Health Policy

Consolidated mail outpatient pharmacy (CMOP) is an automated prescription order processing and delivery system developed by the US Department of Veterans Affairs (VA) in 1994 to provide medications to VA patients.¹ In fiscal year (FY) 2016, CMOP filled about 80% of VA outpatient prescriptions.²

Formalized by the 2010 Memorandum of Understanding between Indian Health Service (IHS) and VA, CMOP is a partnership undertaken to improve the delivery of care to patients by both agencies.³ The number of prescriptions filled by CMOP for IHS patients increased from 1,972 in FY 2010 to 840,109 in FY 2018.⁴ In the fourth quarter of FY 2018, there were 94 CMOP-enrolled IHS federal and tribal sites.⁵ It is only appropriate that a growing number of IHS sites are adopting CMOP considering the evidence for mail-order pharmacy on better patient adherence, improved health outcomes, and potential cost savings.^6-9 Furthermore, using a centralized pharmacy operation, such as CMOP, can lead to better quality services.¹⁰

Crownpoint Health Care Facility (CHCF) serves > 30,000 American Indians and is in Crownpoint, New Mexico, a small community of about 3,000 people.¹¹ Most of the patients served by the facility live in distant places. Many of these underserved patients do not have a stable means of transportation.¹² Therefore, these patients may have difficulty traveling to the facility for their health care needs, including medication pickups. More than 2.5 million American Indians and Alaska Natives IHS beneficiaries face similar challenges due to the rurality of their communities.¹³ CMOP can be a method to increase access to care for this vulnerable population. However, the utilization of CMOP varies significantly among IHS facilities. While some IHS facilities process large numbers of prescriptions through CMOP, other facilities process few, if any. There also are IHS facilities, such as CHCF, which are at the initial stage of implementing CMOP or trying to increase the volume of prescriptions processed through CMOP. Although the utilization of CMOP has grown exponentially among IHS facilities, there is currently no available resource that summarizes the relative advantages and disadvantages, the challenges and opportunities, and the strengths and weaknesses of implementing CMOP for IHS facilities

Methods

A questionnaire encompassing various aspects of CMOP prescription processing was developed and distributed to the primary CMOP contacts for IHS facilities. The questionnaire was first distributed by e-mail on December 19, 2018. It was e-mailed for a second time on January 16, 2019, and the questionnaire was open for responses until the end of January 2019 (Table).

Results

Forty-four of 94 CMOP-enrolled IHS sites responded to the questionnaire. Most sites train the majority of their pharmacists in CMOP prescription processing. Overall, 310 of 347 pharmacists (89%) in these 44 IHS sites can process prescriptions through CMOP. Thirty-one sites have all their pharmacists trained in CMOP prescription processing. Only 1 facility had less than half (2 of 17 pharmacists) of its pharmacists trained in CMOP prescription processing. More than half the total number of pharmacists, 185 out of 347 (53%), check electronic messages via Resource and Patient Management System (RPMS) MailMan to get information about prescriptions rejected by CMOP. Twenty sites have all their pharmacists check messages about CMOP rejections. However, 2 facilities reported that they do not check the rejection messages at all. Twenty-six of the 44 responding sites (59%) transmit prescriptions to CMOP manually in the electronic system. The rest (18 of 44) rely on the auto-transmission (AT) setup to transmit the CMOP-suspended prescriptions at specified times of the day.

Half the sites (8 of 16) that rely on patients asking for prescriptions to be mailed at the time of refill request do not use any method to designate a CMOP patient. Twenty-four sites use the narrative field on the patient’s profile in RPMS, the health information system used by most IHS facilities, to designate CMOP patients. Eighteen sites use pop-up messages on ScriptPro, a pharmacy automation system, as a designation method. Most of the sites (12 of 15) that use both RPMS and ScriptPro designation methods do not require patients to ask for prescriptions to be mailed at the time of refill request; prescriptions for these patients are routed through CMOP unless patients request otherwise. Only 3 of 44 sites use both methods and rely on patients asking for prescriptions to be mailed at the time of refill request. Some other reported designation methods were using the electronic health record (EHR) posting box, keeping a manual list of CMOP patients, and solely utilizing the Prescription Mail Delivery field in RPMS. Three sites also noted that they keep manual lists to auto-refill prescriptions through CMOP.

Thirty sites (68%) reported that they process every prescription through CMOP even if the patient had prescriptions with specified CMOP quantities. Only 8 sites (18%) said that they used the local mail-out program to keep the same days’ supply for all medication orders. For patients with CMOP-ineligible prescriptions, 34 of the 44 sites (77%) process the eligible prescriptions through CMOP and refill the rest of the prescriptions locally. Six sites (14%) process all medication orders locally for patients with any CMOP-ineligible prescriptions.

Only 12 of 44 sites (27%) involve pharmacy technicians in CMOP prescription processing. Five sites have technicians process prescription refills through CMOP. Two of these sites mentioned the strategy of technicians suspending the prescriptions to be sent to CMOP on the refill due date. Other technician roles included tracking CMOP packages, checking electronic messages for CMOP rejections, and signing up patients for CMOP.

Only 3 of the 44 sites (7%) have measured patient satisfaction with the CMOP program. One of these 3 sites reported that the overall satisfaction was high with CMOP. This site administered the survey to patients who came to the clinic for appointments. The second facility called patients and asked for their feedback. The third site conducted the survey by using student pharmacists. Two sites reported that they use the survey results from the CMOP-conducted patient satisfaction surveys, although they have not measured patient satisfaction at their specific facilities.

Most sites have not assessed CMOP’s impact on their insurance (point of sale) collections. However, 13 sites (30%) reported that they believe they are losing on collections by utilizing CMOP. The use of repackaged products by CMOP, which are usually nonreimbursable, is an issue that was mentioned multiple times. In contrast, 2 sites mentioned that CMOP has led to increased insurance collections for their facilities.

Discussion

The utility of CMOP among the responding IHS sites varies quite significantly. Some sites appreciate the convenience of CMOP while acknowledging its limitations, such as the possible decrease in insurance collections, lengthy prescription processing time, or medication backorders. However, some sites have reserved CMOP for special circumstances (eg, mailing refrigerated items to the patient’s street address) due to various complexities that may come with CMOP. One site reported that it compares IHS contract drug prices with VA contract drug prices quarterly to determine which prescriptions should be sent through CMOP.

Most of the IHS pharmacists (89%) are trained in CMOP prescription processing. If an IHS site wants to increase its volume of CMOP prescriptions, it is sensible to train as many pharmacists as possible so that the responsibility does not fall on a few pharmacists. Newly hired pharmacists can receive guidance from trained pharmacists. Designation methods for CMOP patients can be beneficial for these pharmacists to identify CMOP-enrolled patients, especially if the site does not require patients to ask for prescriptions to be mailed at the time of refill request. Only 3 sites (7%) use multiple designation methods in addition to relying on patients to ask for prescriptions to be mailed. Proper implementation of designation methods can remove this extra burden on patients. Conversely, requiring patients to ask for prescriptions to be sent through CMOP can prevent spontaneous mail-outs if a CMOP-designated patient wants to pick up prescriptions locally. Overall, 16 sites (36%) rely on patients asking for prescriptions to be mailed.

One of the main benefits of CMOP is the ability to mail refrigerated items. Local pharmacy mail-out programs may not have this ability. Patients at rural locations often use post office (PO) boxes because they are unable to receive postal services at their physical addresses; however, they may receive packages through United Parcel Service (UPS) at their physical addresses. CMOP uses UPS to send refrigerated items, but UPS does not deliver to PO boxes. Therefore, remotely located sites like CHCF have difficulty in fully optimizing this benefit. One solution is documenting both the physical and mailing addresses on the patient’s EHR, which enables CMOP to send refrigerated items to the patient’s home address via UPS and mail the rest of the prescriptions to the patient’s PO box address with the US Postal Service. The physical address must be listed above the PO box address to ensure that refrigerated items are not rejected by CMOP. Furthermore, both the physical address and the PO box address must be in the same city for this method to work. Two sites noted mailing refrigerated items as one of the major challenges in CMOP prescription processing.

CMOP-enrolled patients must be educated about requesting medications 7 to 10 days before they run out. There is no standard time line for prescriptions filled by CMOP. However, 1 site reported that it may take up to “10 days from time requested to mailbox.” This delay leads to pharmacies facing a dilemma as processing prescriptions too early can lead to insurance rejections, but processing them too late can lead to the patient not receiving the medication by the time they run out of their current supply. However, CMOP provides the ability to track prescriptions sent through CMOP. Pharmacists and technicians need to have access to BestWay Parcel Services Client Portal (genco-mms.bestwayparcel.com) to track CMOP packages. Tracking CMOP prescriptions is a way pharmacy technicians can be involved in CMOP prescription processing. Technicians seem to be underutilized, as only 27% of the responding sites utilize them to some degree in the CMOP process. One site delegated the responsibility of checking CMOP rejection messages to pharmacy technicians. Since 2 of the responding sites do not check CMOP rejection messages at all, this is an excellent opportunity to get pharmacy technicians involved.

A CMOP auto-refill program can potentially be utilized to avoid missed or late medications. In an auto-refill program, a pharmacist can refill prescriptions through CMOP on the due date without a patient request. They may get rejected by insurance the first time they are processed through CMOP for refilling too early if the processing time is taken into account. However, the subsequent refills do not have to consider the CMOP processing time as they would already be synchronized based on the last refill date. Though, if CMOP is out of stock on a medication and it is expected to be available soon, CMOP may take a few extra days to either fill the prescription or reject it if the drug stays unavailable. One of the sites reported “the amount of time [CMOP] holds medications if they are out of stock” as “the hardest thing to work around.” A couple of sites also mentioned the longer than usual delay in processing prescriptions by CMOP during the holidays as one of the major challenges.

CMOP use of repackaged products also may lead insurance companies to deny reimbursement. Repackaged products are usually cheaper to buy.¹⁴ However, most insurances do not reimburse for prescriptions filled with these products.¹⁵ The local drug file on RPMS may have a national drug code (NDC) that is reimbursable by insurance, but CMOP will change it to the repackaged NDC if they are filling the prescription with a repackaged product. One potential solution to this problem would be filling these prescriptions locally. Furthermore, insurance claims are processed when the prescriptions are filled by CMOP. Sites cannot return/cancel the prescription anymore at that point. Therefore, the inability to see real-time rejections as the medication orders are processed on-site makes it challenging to prevent avoidable insurance rejections, such as a refill too soon. One site calculated that it lost $26,386.45 by utilizing CMOP from January 9, 2018 to December 12, 2018. However, it is unclear whether this loss was representative of other sites. It is also worth noting that IHS sites can save a substantial amount of money on certain products by utilizing CMOP because VA buys these products at a reduced price.¹⁶

CMOP-transmitted prescriptions can be rejected for various reasons, such as CMOP manufacturer’s backorder, a different quantity from CMOP stock size, etc. Information about these rejected prescriptions is accessed through electronic messages on RPMS. CMOP does not dispense less than a full, unopened package for most over-the-counter (OTC) medications. The quantity on these prescriptions must be equal to or multiples of the package size for them to be filled by CMOP. This can lead to a patient having prescriptions with different days’ supplies, which results in various refill due dates. If a site has a local mail-out program available, it can potentially keep the same days’ supply for all prescriptions by mailing these OTC medications locally rather than utilizing CMOP. However, this can partially negate CMOP’s benefit of reduced workload.

CMOP also has specified quantities on some prescription medications. One survey respondent viewed “the quantity and day supply required by CMOP” as a negative influence on the site’s insurance collection. It is possible that CMOP does not carry all the medications that a CMOP-enrolled patient is prescribed. Most sites (77%) still send eligible prescriptions through CMOP for the patients who also have CMOP-ineligible prescriptions. There are a small number of sites (14%) that utilize local mail-out program for the patients with any CMOP-ineligible prescriptions, possibly to simplify the process. Schedule II controlled substances cannot be processed through CMOP either; however, facilities may have local policies that prohibit mailing any controlled substances.

Prescriptions can be manually transmitted to CMOP, or they can be automatically transmitted based on the run time and frequency of the auto-transmission setup. The prescriptions that are waiting to be transmitted to CMOP must be in the “suspended” status. The apparent advantage of relying on auto-transmission is that you do not have to complete the steps manually to transmit suspended CMOP prescriptions, thereby making the process more convenient. However, the manual transmission can be utilized as a checkpoint to verify that prescriptions were properly suspended for CMOP, as the prescription status changes from “S” (suspended) to “AT” once the transmission is completed. If a prescription is not properly suspended for CMOP, the status will remain as S even after manual transmission. More than half (59%) of the responding sites must find the manual transmission feature useful as they use it either over or in addition to the auto-transmission setup.

Despite the challenges, many IHS sites process thousands of monthly prescriptions through CMOP. Of the 94 CMOP-enrolled IHS sites, 17 processed > 1,000 prescriptions from March 27, 2019 to April 25, 2019.¹⁷ Five sites processed > 5,000 prescriptions.¹⁷ At the rate of > 5,000 prescriptions per month, the yearly CMOP prescription count will be > 60,000. That is more than one-third of the prescriptions processed by CHCF in 2018. By handling these prescriptions through CMOP, it can decrease pharmacy filling and dispensing workload, thereby freeing pharmacists to participate in other services.¹⁸ Furthermore, implementing CMOP does not incur any cost for the IHS site. There is a nondrug cost for each prescription that is filled through CMOP. This cost was $2.67 during FY 2016.¹⁹ The fee covers prescription vial, label, packaging for mail, postage, personnel, building overhead, and equipment capitalization.¹⁹ The nondrug cost of filling a prescription locally at the site can potentially exceed the cost charged by CMOP.¹⁹

A lack of objective data exists to assess the net impact of CMOP on patients. Different theoretical assumptions can be made, such as CMOP resulting in better patient adherence. However, there is no objective information about how much CMOP improves patient adherence if it does at all. Though J.D. Power US Pharmacy Study ranks CMOP as “among the best” mail-order pharmacies in customer satisfaction, only 3 of the 44 responding sites have measured patient satisfaction locally.²⁰ Only 1 site had objective data about CMOP’s impact on the point of sale. Therefore, it is currently difficult to perform a cost-benefit analysis of the CMOP program. There are opportunities for further studies on these topics.

Limitations

One limitation of this study is that < 50% of the CMOP-enrolled sites (44 of 94) responded to the questionnaire. It is possible that the facilities that had a significantly positive or negative experience with CMOP were more inclined to share their views. Therefore, it is difficult to conclude whether the responding sites are an accurate representative sample. Another limitation of the study was the questionnaire design and the reliance on free-text responses as opposed to structured data. The free-text responses had to be analyzed manually to determine whether they fall in the same category, thereby increasing the risk of interpretation error.

Conclusion

CMOP has its unique challenges but provides many benefits that local pharmacy mail-out programs may not possess, such as the abilities to mail refrigerated items and track packages. One must be familiar with CMOP’s various idiosyncrasies to make the best use of the program. Extensive staff education and orientation for new staff members must be done to familiarize them with the program. Nevertheless, the successful implementation of CMOP can lead to reduced pharmacy workload while increasing access to care for patients with transportation issues.

Acknowledgments
The authors thank LCDR Karsten Smith, PharmD, BCGP, the IHS CMOP Coordinator for providing the list of primary CMOP contacts and CDR Kendall Van Tyle, PharmD, BCPS, for proofreading the article.

Consolidated mail outpatient pharmacy (CMOP) is an automated prescription order processing and delivery system developed by the US Department of Veterans Affairs (VA) in 1994 to provide medications to VA patients.¹ In fiscal year (FY) 2016, CMOP filled about 80% of VA outpatient prescriptions.²

Formalized by the 2010 Memorandum of Understanding between Indian Health Service (IHS) and VA, CMOP is a partnership undertaken to improve the delivery of care to patients by both agencies.³ The number of prescriptions filled by CMOP for IHS patients increased from 1,972 in FY 2010 to 840,109 in FY 2018.⁴ In the fourth quarter of FY 2018, there were 94 CMOP-enrolled IHS federal and tribal sites.⁵ It is only appropriate that a growing number of IHS sites are adopting CMOP considering the evidence for mail-order pharmacy on better patient adherence, improved health outcomes, and potential cost savings.^6-9 Furthermore, using a centralized pharmacy operation, such as CMOP, can lead to better quality services.¹⁰

Crownpoint Health Care Facility (CHCF) serves > 30,000 American Indians and is in Crownpoint, New Mexico, a small community of about 3,000 people.¹¹ Most of the patients served by the facility live in distant places. Many of these underserved patients do not have a stable means of transportation.¹² Therefore, these patients may have difficulty traveling to the facility for their health care needs, including medication pickups. More than 2.5 million American Indians and Alaska Natives IHS beneficiaries face similar challenges due to the rurality of their communities.¹³ CMOP can be a method to increase access to care for this vulnerable population. However, the utilization of CMOP varies significantly among IHS facilities. While some IHS facilities process large numbers of prescriptions through CMOP, other facilities process few, if any. There also are IHS facilities, such as CHCF, which are at the initial stage of implementing CMOP or trying to increase the volume of prescriptions processed through CMOP. Although the utilization of CMOP has grown exponentially among IHS facilities, there is currently no available resource that summarizes the relative advantages and disadvantages, the challenges and opportunities, and the strengths and weaknesses of implementing CMOP for IHS facilities

Methods

A questionnaire encompassing various aspects of CMOP prescription processing was developed and distributed to the primary CMOP contacts for IHS facilities. The questionnaire was first distributed by e-mail on December 19, 2018. It was e-mailed for a second time on January 16, 2019, and the questionnaire was open for responses until the end of January 2019 (Table).

Results

Forty-four of 94 CMOP-enrolled IHS sites responded to the questionnaire. Most sites train the majority of their pharmacists in CMOP prescription processing. Overall, 310 of 347 pharmacists (89%) in these 44 IHS sites can process prescriptions through CMOP. Thirty-one sites have all their pharmacists trained in CMOP prescription processing. Only 1 facility had less than half (2 of 17 pharmacists) of its pharmacists trained in CMOP prescription processing. More than half the total number of pharmacists, 185 out of 347 (53%), check electronic messages via Resource and Patient Management System (RPMS) MailMan to get information about prescriptions rejected by CMOP. Twenty sites have all their pharmacists check messages about CMOP rejections. However, 2 facilities reported that they do not check the rejection messages at all. Twenty-six of the 44 responding sites (59%) transmit prescriptions to CMOP manually in the electronic system. The rest (18 of 44) rely on the auto-transmission (AT) setup to transmit the CMOP-suspended prescriptions at specified times of the day.

Half the sites (8 of 16) that rely on patients asking for prescriptions to be mailed at the time of refill request do not use any method to designate a CMOP patient. Twenty-four sites use the narrative field on the patient’s profile in RPMS, the health information system used by most IHS facilities, to designate CMOP patients. Eighteen sites use pop-up messages on ScriptPro, a pharmacy automation system, as a designation method. Most of the sites (12 of 15) that use both RPMS and ScriptPro designation methods do not require patients to ask for prescriptions to be mailed at the time of refill request; prescriptions for these patients are routed through CMOP unless patients request otherwise. Only 3 of 44 sites use both methods and rely on patients asking for prescriptions to be mailed at the time of refill request. Some other reported designation methods were using the electronic health record (EHR) posting box, keeping a manual list of CMOP patients, and solely utilizing the Prescription Mail Delivery field in RPMS. Three sites also noted that they keep manual lists to auto-refill prescriptions through CMOP.

Thirty sites (68%) reported that they process every prescription through CMOP even if the patient had prescriptions with specified CMOP quantities. Only 8 sites (18%) said that they used the local mail-out program to keep the same days’ supply for all medication orders. For patients with CMOP-ineligible prescriptions, 34 of the 44 sites (77%) process the eligible prescriptions through CMOP and refill the rest of the prescriptions locally. Six sites (14%) process all medication orders locally for patients with any CMOP-ineligible prescriptions.

Only 12 of 44 sites (27%) involve pharmacy technicians in CMOP prescription processing. Five sites have technicians process prescription refills through CMOP. Two of these sites mentioned the strategy of technicians suspending the prescriptions to be sent to CMOP on the refill due date. Other technician roles included tracking CMOP packages, checking electronic messages for CMOP rejections, and signing up patients for CMOP.

Only 3 of the 44 sites (7%) have measured patient satisfaction with the CMOP program. One of these 3 sites reported that the overall satisfaction was high with CMOP. This site administered the survey to patients who came to the clinic for appointments. The second facility called patients and asked for their feedback. The third site conducted the survey by using student pharmacists. Two sites reported that they use the survey results from the CMOP-conducted patient satisfaction surveys, although they have not measured patient satisfaction at their specific facilities.

Most sites have not assessed CMOP’s impact on their insurance (point of sale) collections. However, 13 sites (30%) reported that they believe they are losing on collections by utilizing CMOP. The use of repackaged products by CMOP, which are usually nonreimbursable, is an issue that was mentioned multiple times. In contrast, 2 sites mentioned that CMOP has led to increased insurance collections for their facilities.

Discussion

The utility of CMOP among the responding IHS sites varies quite significantly. Some sites appreciate the convenience of CMOP while acknowledging its limitations, such as the possible decrease in insurance collections, lengthy prescription processing time, or medication backorders. However, some sites have reserved CMOP for special circumstances (eg, mailing refrigerated items to the patient’s street address) due to various complexities that may come with CMOP. One site reported that it compares IHS contract drug prices with VA contract drug prices quarterly to determine which prescriptions should be sent through CMOP.

Most of the IHS pharmacists (89%) are trained in CMOP prescription processing. If an IHS site wants to increase its volume of CMOP prescriptions, it is sensible to train as many pharmacists as possible so that the responsibility does not fall on a few pharmacists. Newly hired pharmacists can receive guidance from trained pharmacists. Designation methods for CMOP patients can be beneficial for these pharmacists to identify CMOP-enrolled patients, especially if the site does not require patients to ask for prescriptions to be mailed at the time of refill request. Only 3 sites (7%) use multiple designation methods in addition to relying on patients to ask for prescriptions to be mailed. Proper implementation of designation methods can remove this extra burden on patients. Conversely, requiring patients to ask for prescriptions to be sent through CMOP can prevent spontaneous mail-outs if a CMOP-designated patient wants to pick up prescriptions locally. Overall, 16 sites (36%) rely on patients asking for prescriptions to be mailed.

One of the main benefits of CMOP is the ability to mail refrigerated items. Local pharmacy mail-out programs may not have this ability. Patients at rural locations often use post office (PO) boxes because they are unable to receive postal services at their physical addresses; however, they may receive packages through United Parcel Service (UPS) at their physical addresses. CMOP uses UPS to send refrigerated items, but UPS does not deliver to PO boxes. Therefore, remotely located sites like CHCF have difficulty in fully optimizing this benefit. One solution is documenting both the physical and mailing addresses on the patient’s EHR, which enables CMOP to send refrigerated items to the patient’s home address via UPS and mail the rest of the prescriptions to the patient’s PO box address with the US Postal Service. The physical address must be listed above the PO box address to ensure that refrigerated items are not rejected by CMOP. Furthermore, both the physical address and the PO box address must be in the same city for this method to work. Two sites noted mailing refrigerated items as one of the major challenges in CMOP prescription processing.

CMOP-enrolled patients must be educated about requesting medications 7 to 10 days before they run out. There is no standard time line for prescriptions filled by CMOP. However, 1 site reported that it may take up to “10 days from time requested to mailbox.” This delay leads to pharmacies facing a dilemma as processing prescriptions too early can lead to insurance rejections, but processing them too late can lead to the patient not receiving the medication by the time they run out of their current supply. However, CMOP provides the ability to track prescriptions sent through CMOP. Pharmacists and technicians need to have access to BestWay Parcel Services Client Portal (genco-mms.bestwayparcel.com) to track CMOP packages. Tracking CMOP prescriptions is a way pharmacy technicians can be involved in CMOP prescription processing. Technicians seem to be underutilized, as only 27% of the responding sites utilize them to some degree in the CMOP process. One site delegated the responsibility of checking CMOP rejection messages to pharmacy technicians. Since 2 of the responding sites do not check CMOP rejection messages at all, this is an excellent opportunity to get pharmacy technicians involved.

A CMOP auto-refill program can potentially be utilized to avoid missed or late medications. In an auto-refill program, a pharmacist can refill prescriptions through CMOP on the due date without a patient request. They may get rejected by insurance the first time they are processed through CMOP for refilling too early if the processing time is taken into account. However, the subsequent refills do not have to consider the CMOP processing time as they would already be synchronized based on the last refill date. Though, if CMOP is out of stock on a medication and it is expected to be available soon, CMOP may take a few extra days to either fill the prescription or reject it if the drug stays unavailable. One of the sites reported “the amount of time [CMOP] holds medications if they are out of stock” as “the hardest thing to work around.” A couple of sites also mentioned the longer than usual delay in processing prescriptions by CMOP during the holidays as one of the major challenges.

CMOP use of repackaged products also may lead insurance companies to deny reimbursement. Repackaged products are usually cheaper to buy.¹⁴ However, most insurances do not reimburse for prescriptions filled with these products.¹⁵ The local drug file on RPMS may have a national drug code (NDC) that is reimbursable by insurance, but CMOP will change it to the repackaged NDC if they are filling the prescription with a repackaged product. One potential solution to this problem would be filling these prescriptions locally. Furthermore, insurance claims are processed when the prescriptions are filled by CMOP. Sites cannot return/cancel the prescription anymore at that point. Therefore, the inability to see real-time rejections as the medication orders are processed on-site makes it challenging to prevent avoidable insurance rejections, such as a refill too soon. One site calculated that it lost $26,386.45 by utilizing CMOP from January 9, 2018 to December 12, 2018. However, it is unclear whether this loss was representative of other sites. It is also worth noting that IHS sites can save a substantial amount of money on certain products by utilizing CMOP because VA buys these products at a reduced price.¹⁶

CMOP-transmitted prescriptions can be rejected for various reasons, such as CMOP manufacturer’s backorder, a different quantity from CMOP stock size, etc. Information about these rejected prescriptions is accessed through electronic messages on RPMS. CMOP does not dispense less than a full, unopened package for most over-the-counter (OTC) medications. The quantity on these prescriptions must be equal to or multiples of the package size for them to be filled by CMOP. This can lead to a patient having prescriptions with different days’ supplies, which results in various refill due dates. If a site has a local mail-out program available, it can potentially keep the same days’ supply for all prescriptions by mailing these OTC medications locally rather than utilizing CMOP. However, this can partially negate CMOP’s benefit of reduced workload.

CMOP also has specified quantities on some prescription medications. One survey respondent viewed “the quantity and day supply required by CMOP” as a negative influence on the site’s insurance collection. It is possible that CMOP does not carry all the medications that a CMOP-enrolled patient is prescribed. Most sites (77%) still send eligible prescriptions through CMOP for the patients who also have CMOP-ineligible prescriptions. There are a small number of sites (14%) that utilize local mail-out program for the patients with any CMOP-ineligible prescriptions, possibly to simplify the process. Schedule II controlled substances cannot be processed through CMOP either; however, facilities may have local policies that prohibit mailing any controlled substances.

Prescriptions can be manually transmitted to CMOP, or they can be automatically transmitted based on the run time and frequency of the auto-transmission setup. The prescriptions that are waiting to be transmitted to CMOP must be in the “suspended” status. The apparent advantage of relying on auto-transmission is that you do not have to complete the steps manually to transmit suspended CMOP prescriptions, thereby making the process more convenient. However, the manual transmission can be utilized as a checkpoint to verify that prescriptions were properly suspended for CMOP, as the prescription status changes from “S” (suspended) to “AT” once the transmission is completed. If a prescription is not properly suspended for CMOP, the status will remain as S even after manual transmission. More than half (59%) of the responding sites must find the manual transmission feature useful as they use it either over or in addition to the auto-transmission setup.

Despite the challenges, many IHS sites process thousands of monthly prescriptions through CMOP. Of the 94 CMOP-enrolled IHS sites, 17 processed > 1,000 prescriptions from March 27, 2019 to April 25, 2019.¹⁷ Five sites processed > 5,000 prescriptions.¹⁷ At the rate of > 5,000 prescriptions per month, the yearly CMOP prescription count will be > 60,000. That is more than one-third of the prescriptions processed by CHCF in 2018. By handling these prescriptions through CMOP, it can decrease pharmacy filling and dispensing workload, thereby freeing pharmacists to participate in other services.¹⁸ Furthermore, implementing CMOP does not incur any cost for the IHS site. There is a nondrug cost for each prescription that is filled through CMOP. This cost was $2.67 during FY 2016.¹⁹ The fee covers prescription vial, label, packaging for mail, postage, personnel, building overhead, and equipment capitalization.¹⁹ The nondrug cost of filling a prescription locally at the site can potentially exceed the cost charged by CMOP.¹⁹

A lack of objective data exists to assess the net impact of CMOP on patients. Different theoretical assumptions can be made, such as CMOP resulting in better patient adherence. However, there is no objective information about how much CMOP improves patient adherence if it does at all. Though J.D. Power US Pharmacy Study ranks CMOP as “among the best” mail-order pharmacies in customer satisfaction, only 3 of the 44 responding sites have measured patient satisfaction locally.²⁰ Only 1 site had objective data about CMOP’s impact on the point of sale. Therefore, it is currently difficult to perform a cost-benefit analysis of the CMOP program. There are opportunities for further studies on these topics.

Limitations

One limitation of this study is that < 50% of the CMOP-enrolled sites (44 of 94) responded to the questionnaire. It is possible that the facilities that had a significantly positive or negative experience with CMOP were more inclined to share their views. Therefore, it is difficult to conclude whether the responding sites are an accurate representative sample. Another limitation of the study was the questionnaire design and the reliance on free-text responses as opposed to structured data. The free-text responses had to be analyzed manually to determine whether they fall in the same category, thereby increasing the risk of interpretation error.

Conclusion

CMOP has its unique challenges but provides many benefits that local pharmacy mail-out programs may not possess, such as the abilities to mail refrigerated items and track packages. One must be familiar with CMOP’s various idiosyncrasies to make the best use of the program. Extensive staff education and orientation for new staff members must be done to familiarize them with the program. Nevertheless, the successful implementation of CMOP can lead to reduced pharmacy workload while increasing access to care for patients with transportation issues.

Acknowledgments
The authors thank LCDR Karsten Smith, PharmD, BCGP, the IHS CMOP Coordinator for providing the list of primary CMOP contacts and CDR Kendall Van Tyle, PharmD, BCPS, for proofreading the article.

Consolidated mail outpatient pharmacy (CMOP) is an automated prescription order processing and delivery system developed by the US Department of Veterans Affairs (VA) in 1994 to provide medications to VA patients.¹ In fiscal year (FY) 2016, CMOP filled about 80% of VA outpatient prescriptions.²

Formalized by the 2010 Memorandum of Understanding between Indian Health Service (IHS) and VA, CMOP is a partnership undertaken to improve the delivery of care to patients by both agencies.³ The number of prescriptions filled by CMOP for IHS patients increased from 1,972 in FY 2010 to 840,109 in FY 2018.⁴ In the fourth quarter of FY 2018, there were 94 CMOP-enrolled IHS federal and tribal sites.⁵ It is only appropriate that a growing number of IHS sites are adopting CMOP considering the evidence for mail-order pharmacy on better patient adherence, improved health outcomes, and potential cost savings.^6-9 Furthermore, using a centralized pharmacy operation, such as CMOP, can lead to better quality services.¹⁰

Crownpoint Health Care Facility (CHCF) serves > 30,000 American Indians and is in Crownpoint, New Mexico, a small community of about 3,000 people.¹¹ Most of the patients served by the facility live in distant places. Many of these underserved patients do not have a stable means of transportation.¹² Therefore, these patients may have difficulty traveling to the facility for their health care needs, including medication pickups. More than 2.5 million American Indians and Alaska Natives IHS beneficiaries face similar challenges due to the rurality of their communities.¹³ CMOP can be a method to increase access to care for this vulnerable population. However, the utilization of CMOP varies significantly among IHS facilities. While some IHS facilities process large numbers of prescriptions through CMOP, other facilities process few, if any. There also are IHS facilities, such as CHCF, which are at the initial stage of implementing CMOP or trying to increase the volume of prescriptions processed through CMOP. Although the utilization of CMOP has grown exponentially among IHS facilities, there is currently no available resource that summarizes the relative advantages and disadvantages, the challenges and opportunities, and the strengths and weaknesses of implementing CMOP for IHS facilities

Methods

A questionnaire encompassing various aspects of CMOP prescription processing was developed and distributed to the primary CMOP contacts for IHS facilities. The questionnaire was first distributed by e-mail on December 19, 2018. It was e-mailed for a second time on January 16, 2019, and the questionnaire was open for responses until the end of January 2019 (Table).

Results

Forty-four of 94 CMOP-enrolled IHS sites responded to the questionnaire. Most sites train the majority of their pharmacists in CMOP prescription processing. Overall, 310 of 347 pharmacists (89%) in these 44 IHS sites can process prescriptions through CMOP. Thirty-one sites have all their pharmacists trained in CMOP prescription processing. Only 1 facility had less than half (2 of 17 pharmacists) of its pharmacists trained in CMOP prescription processing. More than half the total number of pharmacists, 185 out of 347 (53%), check electronic messages via Resource and Patient Management System (RPMS) MailMan to get information about prescriptions rejected by CMOP. Twenty sites have all their pharmacists check messages about CMOP rejections. However, 2 facilities reported that they do not check the rejection messages at all. Twenty-six of the 44 responding sites (59%) transmit prescriptions to CMOP manually in the electronic system. The rest (18 of 44) rely on the auto-transmission (AT) setup to transmit the CMOP-suspended prescriptions at specified times of the day.

Half the sites (8 of 16) that rely on patients asking for prescriptions to be mailed at the time of refill request do not use any method to designate a CMOP patient. Twenty-four sites use the narrative field on the patient’s profile in RPMS, the health information system used by most IHS facilities, to designate CMOP patients. Eighteen sites use pop-up messages on ScriptPro, a pharmacy automation system, as a designation method. Most of the sites (12 of 15) that use both RPMS and ScriptPro designation methods do not require patients to ask for prescriptions to be mailed at the time of refill request; prescriptions for these patients are routed through CMOP unless patients request otherwise. Only 3 of 44 sites use both methods and rely on patients asking for prescriptions to be mailed at the time of refill request. Some other reported designation methods were using the electronic health record (EHR) posting box, keeping a manual list of CMOP patients, and solely utilizing the Prescription Mail Delivery field in RPMS. Three sites also noted that they keep manual lists to auto-refill prescriptions through CMOP.

Thirty sites (68%) reported that they process every prescription through CMOP even if the patient had prescriptions with specified CMOP quantities. Only 8 sites (18%) said that they used the local mail-out program to keep the same days’ supply for all medication orders. For patients with CMOP-ineligible prescriptions, 34 of the 44 sites (77%) process the eligible prescriptions through CMOP and refill the rest of the prescriptions locally. Six sites (14%) process all medication orders locally for patients with any CMOP-ineligible prescriptions.

Only 12 of 44 sites (27%) involve pharmacy technicians in CMOP prescription processing. Five sites have technicians process prescription refills through CMOP. Two of these sites mentioned the strategy of technicians suspending the prescriptions to be sent to CMOP on the refill due date. Other technician roles included tracking CMOP packages, checking electronic messages for CMOP rejections, and signing up patients for CMOP.

Only 3 of the 44 sites (7%) have measured patient satisfaction with the CMOP program. One of these 3 sites reported that the overall satisfaction was high with CMOP. This site administered the survey to patients who came to the clinic for appointments. The second facility called patients and asked for their feedback. The third site conducted the survey by using student pharmacists. Two sites reported that they use the survey results from the CMOP-conducted patient satisfaction surveys, although they have not measured patient satisfaction at their specific facilities.

Most sites have not assessed CMOP’s impact on their insurance (point of sale) collections. However, 13 sites (30%) reported that they believe they are losing on collections by utilizing CMOP. The use of repackaged products by CMOP, which are usually nonreimbursable, is an issue that was mentioned multiple times. In contrast, 2 sites mentioned that CMOP has led to increased insurance collections for their facilities.

Discussion

The utility of CMOP among the responding IHS sites varies quite significantly. Some sites appreciate the convenience of CMOP while acknowledging its limitations, such as the possible decrease in insurance collections, lengthy prescription processing time, or medication backorders. However, some sites have reserved CMOP for special circumstances (eg, mailing refrigerated items to the patient’s street address) due to various complexities that may come with CMOP. One site reported that it compares IHS contract drug prices with VA contract drug prices quarterly to determine which prescriptions should be sent through CMOP.

Most of the IHS pharmacists (89%) are trained in CMOP prescription processing. If an IHS site wants to increase its volume of CMOP prescriptions, it is sensible to train as many pharmacists as possible so that the responsibility does not fall on a few pharmacists. Newly hired pharmacists can receive guidance from trained pharmacists. Designation methods for CMOP patients can be beneficial for these pharmacists to identify CMOP-enrolled patients, especially if the site does not require patients to ask for prescriptions to be mailed at the time of refill request. Only 3 sites (7%) use multiple designation methods in addition to relying on patients to ask for prescriptions to be mailed. Proper implementation of designation methods can remove this extra burden on patients. Conversely, requiring patients to ask for prescriptions to be sent through CMOP can prevent spontaneous mail-outs if a CMOP-designated patient wants to pick up prescriptions locally. Overall, 16 sites (36%) rely on patients asking for prescriptions to be mailed.

One of the main benefits of CMOP is the ability to mail refrigerated items. Local pharmacy mail-out programs may not have this ability. Patients at rural locations often use post office (PO) boxes because they are unable to receive postal services at their physical addresses; however, they may receive packages through United Parcel Service (UPS) at their physical addresses. CMOP uses UPS to send refrigerated items, but UPS does not deliver to PO boxes. Therefore, remotely located sites like CHCF have difficulty in fully optimizing this benefit. One solution is documenting both the physical and mailing addresses on the patient’s EHR, which enables CMOP to send refrigerated items to the patient’s home address via UPS and mail the rest of the prescriptions to the patient’s PO box address with the US Postal Service. The physical address must be listed above the PO box address to ensure that refrigerated items are not rejected by CMOP. Furthermore, both the physical address and the PO box address must be in the same city for this method to work. Two sites noted mailing refrigerated items as one of the major challenges in CMOP prescription processing.

CMOP-enrolled patients must be educated about requesting medications 7 to 10 days before they run out. There is no standard time line for prescriptions filled by CMOP. However, 1 site reported that it may take up to “10 days from time requested to mailbox.” This delay leads to pharmacies facing a dilemma as processing prescriptions too early can lead to insurance rejections, but processing them too late can lead to the patient not receiving the medication by the time they run out of their current supply. However, CMOP provides the ability to track prescriptions sent through CMOP. Pharmacists and technicians need to have access to BestWay Parcel Services Client Portal (genco-mms.bestwayparcel.com) to track CMOP packages. Tracking CMOP prescriptions is a way pharmacy technicians can be involved in CMOP prescription processing. Technicians seem to be underutilized, as only 27% of the responding sites utilize them to some degree in the CMOP process. One site delegated the responsibility of checking CMOP rejection messages to pharmacy technicians. Since 2 of the responding sites do not check CMOP rejection messages at all, this is an excellent opportunity to get pharmacy technicians involved.

A CMOP auto-refill program can potentially be utilized to avoid missed or late medications. In an auto-refill program, a pharmacist can refill prescriptions through CMOP on the due date without a patient request. They may get rejected by insurance the first time they are processed through CMOP for refilling too early if the processing time is taken into account. However, the subsequent refills do not have to consider the CMOP processing time as they would already be synchronized based on the last refill date. Though, if CMOP is out of stock on a medication and it is expected to be available soon, CMOP may take a few extra days to either fill the prescription or reject it if the drug stays unavailable. One of the sites reported “the amount of time [CMOP] holds medications if they are out of stock” as “the hardest thing to work around.” A couple of sites also mentioned the longer than usual delay in processing prescriptions by CMOP during the holidays as one of the major challenges.

CMOP use of repackaged products also may lead insurance companies to deny reimbursement. Repackaged products are usually cheaper to buy.¹⁴ However, most insurances do not reimburse for prescriptions filled with these products.¹⁵ The local drug file on RPMS may have a national drug code (NDC) that is reimbursable by insurance, but CMOP will change it to the repackaged NDC if they are filling the prescription with a repackaged product. One potential solution to this problem would be filling these prescriptions locally. Furthermore, insurance claims are processed when the prescriptions are filled by CMOP. Sites cannot return/cancel the prescription anymore at that point. Therefore, the inability to see real-time rejections as the medication orders are processed on-site makes it challenging to prevent avoidable insurance rejections, such as a refill too soon. One site calculated that it lost $26,386.45 by utilizing CMOP from January 9, 2018 to December 12, 2018. However, it is unclear whether this loss was representative of other sites. It is also worth noting that IHS sites can save a substantial amount of money on certain products by utilizing CMOP because VA buys these products at a reduced price.¹⁶

CMOP-transmitted prescriptions can be rejected for various reasons, such as CMOP manufacturer’s backorder, a different quantity from CMOP stock size, etc. Information about these rejected prescriptions is accessed through electronic messages on RPMS. CMOP does not dispense less than a full, unopened package for most over-the-counter (OTC) medications. The quantity on these prescriptions must be equal to or multiples of the package size for them to be filled by CMOP. This can lead to a patient having prescriptions with different days’ supplies, which results in various refill due dates. If a site has a local mail-out program available, it can potentially keep the same days’ supply for all prescriptions by mailing these OTC medications locally rather than utilizing CMOP. However, this can partially negate CMOP’s benefit of reduced workload.

CMOP also has specified quantities on some prescription medications. One survey respondent viewed “the quantity and day supply required by CMOP” as a negative influence on the site’s insurance collection. It is possible that CMOP does not carry all the medications that a CMOP-enrolled patient is prescribed. Most sites (77%) still send eligible prescriptions through CMOP for the patients who also have CMOP-ineligible prescriptions. There are a small number of sites (14%) that utilize local mail-out program for the patients with any CMOP-ineligible prescriptions, possibly to simplify the process. Schedule II controlled substances cannot be processed through CMOP either; however, facilities may have local policies that prohibit mailing any controlled substances.

Prescriptions can be manually transmitted to CMOP, or they can be automatically transmitted based on the run time and frequency of the auto-transmission setup. The prescriptions that are waiting to be transmitted to CMOP must be in the “suspended” status. The apparent advantage of relying on auto-transmission is that you do not have to complete the steps manually to transmit suspended CMOP prescriptions, thereby making the process more convenient. However, the manual transmission can be utilized as a checkpoint to verify that prescriptions were properly suspended for CMOP, as the prescription status changes from “S” (suspended) to “AT” once the transmission is completed. If a prescription is not properly suspended for CMOP, the status will remain as S even after manual transmission. More than half (59%) of the responding sites must find the manual transmission feature useful as they use it either over or in addition to the auto-transmission setup.

Despite the challenges, many IHS sites process thousands of monthly prescriptions through CMOP. Of the 94 CMOP-enrolled IHS sites, 17 processed > 1,000 prescriptions from March 27, 2019 to April 25, 2019.¹⁷ Five sites processed > 5,000 prescriptions.¹⁷ At the rate of > 5,000 prescriptions per month, the yearly CMOP prescription count will be > 60,000. That is more than one-third of the prescriptions processed by CHCF in 2018. By handling these prescriptions through CMOP, it can decrease pharmacy filling and dispensing workload, thereby freeing pharmacists to participate in other services.¹⁸ Furthermore, implementing CMOP does not incur any cost for the IHS site. There is a nondrug cost for each prescription that is filled through CMOP. This cost was $2.67 during FY 2016.¹⁹ The fee covers prescription vial, label, packaging for mail, postage, personnel, building overhead, and equipment capitalization.¹⁹ The nondrug cost of filling a prescription locally at the site can potentially exceed the cost charged by CMOP.¹⁹

A lack of objective data exists to assess the net impact of CMOP on patients. Different theoretical assumptions can be made, such as CMOP resulting in better patient adherence. However, there is no objective information about how much CMOP improves patient adherence if it does at all. Though J.D. Power US Pharmacy Study ranks CMOP as “among the best” mail-order pharmacies in customer satisfaction, only 3 of the 44 responding sites have measured patient satisfaction locally.²⁰ Only 1 site had objective data about CMOP’s impact on the point of sale. Therefore, it is currently difficult to perform a cost-benefit analysis of the CMOP program. There are opportunities for further studies on these topics.

Limitations

One limitation of this study is that < 50% of the CMOP-enrolled sites (44 of 94) responded to the questionnaire. It is possible that the facilities that had a significantly positive or negative experience with CMOP were more inclined to share their views. Therefore, it is difficult to conclude whether the responding sites are an accurate representative sample. Another limitation of the study was the questionnaire design and the reliance on free-text responses as opposed to structured data. The free-text responses had to be analyzed manually to determine whether they fall in the same category, thereby increasing the risk of interpretation error.

Conclusion

CMOP has its unique challenges but provides many benefits that local pharmacy mail-out programs may not possess, such as the abilities to mail refrigerated items and track packages. One must be familiar with CMOP’s various idiosyncrasies to make the best use of the program. Extensive staff education and orientation for new staff members must be done to familiarize them with the program. Nevertheless, the successful implementation of CMOP can lead to reduced pharmacy workload while increasing access to care for patients with transportation issues.

Acknowledgments
The authors thank LCDR Karsten Smith, PharmD, BCGP, the IHS CMOP Coordinator for providing the list of primary CMOP contacts and CDR Kendall Van Tyle, PharmD, BCPS, for proofreading the article.

In the first 2 articles of this series, “Telemedicine: A primer for today’s ObGyn” and “Telemedicine: Common hurdles and proper coding for ObGyns,” which appeared in the May and June issues of OBG Management, we discussed caring for patients without face-to-face visits and that virtual visits are an opportunity to provide good care in a world such as that created by COVID-19. We also discussed which patients are the most appropriate candidates for telemedicine, as well as how to properly code virtual visits so that you are paid for your time and service. This third article addresses the legal concerns and caveats of using telemedicine and makes a prediction for the future of virtual health care.

Legal issues surrounding telemedicine

There are numerous legal, regulatory, and compliance issues that existed before the pandemic that likely will continue to be of concern postpandemic. Although the recent 1135 waiver (allowing Medicare to pay for office, hospital, and other visits furnished via telehealth)¹ and other regulations are now in place for almost every aspect of telemedicine, virtual medicine is not a free-for-all (even though it may seem like it). Practicing ethical telemedicine entails abiding by numerous federal and state-specific laws and requirements. It is important to be aware of the laws in each state in which your patients are located and to practice according to the requirements of these laws. This often requires consultation with an experienced health care attorney who is knowledgeable about the use of telemedicine and who can help you with issues surrounding:

• Malpractice insurance. It is an important first step to contact your practice’s malpractice insurance carrier and confirm coverage for telemedicine visits. Telemedicine visits are considered the same as in-person visits when determining scope of practice and malpractice liability. Nevertheless, a best practice is to have written verification from your malpractice carrier about the types of telemedicine services and claims for which your ObGyn practice is covered. Additionally, if you care for patients virtually who live in a state in which you are not licensed, check with your carrier to determine if potential claims will be covered.
• Corporate practice laws. These laws require that your practice be governed by a health care professional and not someone with a nonmedical background. This becomes important if you are looking to create a virtual practice in another state. States that prohibit the corporate practice of medicine have state-specific mandates that require strict adherence. Consult with a health care attorney before entering into a business arrangement with a nonphysician or corporate entity.
• Delegation agreement requirements. These laws require physician collaboration and/or supervision of allied health care workers such as nurse practitioners (NPs) and physician assistants (PAs) and may limit the number of allied health care providers that a physician may supervise. Many states are allowing allied health care workers to practice at the top of their license, but this is still state specific. Thus, it is an important issue to consider, especially for practices that rely heavily on the services of advanced practice registered nurses (APRNs), for example, who have a broad scope of practice and who may be qualified to care for many common ObGyn problems.
• Informed consent requirements. Some states have no requirements regarding consent for a virtual visit. Others require either written or verbal consent. In states that do not require informed consent, it is best practice to nevertheless obtain either written or oral consent and to document in the patient’s record that consent was obtained before initiating a virtual visit. The consent should follow state-mandated disclosures, as well as the practice’s policies regarding billing, scheduling, and cancellations of telemedicine visits.
• Interstate licensing laws. Because of the COVID-19 pandemic, federal and state licensure waivers are in place to allow physicians to care for patients outside the physician’s home state, but these waivers likely will be lifted postpandemic. Once waivers are lifted, physicians will need to be licensed not only in the state in which they practice but also in the state where the patient is located at the time of treatment. Even physicians who practice in states that belong to the Interstate Medical Licensure Compact² must apply for and obtain a license to practice within Compact member states. Membership in the Interstate Medical Licensure Compact expedites the licensure process, but does not alleviate the need to obtain a license to practice in each member state. To ensure compliance with interstate licensure laws, seek advice from a health care attorney specializing in telemedicine.
• Drug monitoring laws. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008³ implemented a requirement that physicians have at least one in-person, face-to-face visit with patients before prescribing a controlled substance for the first time. Because state laws may vary, we suggest consulting with a health care attorney to understand your state’s requirements for prescribing controlled substances to new patients and when using telemedicine (see “Prescription drugs” at https://www.cdc.gov/phlp/publications/topic/prescription.html for more information).
• Data privacy and security. From a content perspective, health care data and personally identifiable information are extremely rich, which makes electronic health records (EHRs), or the digital form of patients’ medical histories and other data, particularly tempting targets for hackers and cyber criminals. We caution that services such as Facetime and Skype are not encrypted; they have been granted waivers for telemedicine use, but these waivers are probably not going to be permanent once the COVID-19 crisis passes.
• HIPAA compliance. Generally—and certainly under normal circumstances—telemedicine is subject to the same rules governing protected health information (PHI) as any other technology and process used in physician practices. The Health Insurance Portability and Accountability Act (HIPAA) Security Rule includes guidelines on telemedicine and stipulates that only authorized users should have access to ePHI, that a system of secure communication must be established to protect the security of ePHI, and that a system to monitor communications must be maintained, among other requirements.⁴ Third parties that provide telemedicine, data storage, and other services, with a few exceptions, must have a business associate agreement (BAA) with a covered entity. Covered entities include health care providers, health plans, and health and health care clearinghouses. Such an agreement should include specific language that ensures that HIPAA requirements will be met and that governs permitted and required uses of PHI, strictly limits other uses of PHI, and establishes appropriate safeguards and steps that must be taken in the event of a breach or disallowed disclosure of PHI. Best practice requires that providers establish robust protocols, policies, and processes for handling sensitive information.

During the COVID-19 pandemic, however, certain HIPAA restrictions relating to telemedicine have been temporarily waived by the US Department of Health and Human Services (HHS). More specifically, HHS Secretary Alex Azar has exercised his authority to waive sanctions against covered hospitals for noncompliance with requirements: to obtain a patient’s consent to speak with family members or friends involved in the patient’s care, to distribute a notice of privacy practices, to request privacy restrictions, to request confidential communications, and the use of nonpublic facing audio and video communications products, among others.⁵ These are temporary measures only; once the national public health emergency has passed or at the HHS Secretary’s discretion based on new developments, this position on discretionary nonenforcement may end.

Continue to: Crisis creates opportunity: The future of telemedicine...

Crisis creates opportunity: The future of telemedicine

It was just a few years ago when the use of telemedicine was relegated to treating patients in only rural areas or those located a great distance from brick and mortar practices. But the pandemic, along with the coincident relaxation of the Centers for Medicare and Medicaid Services’ (CMS) requirements for conducting telemedicine visits has made the technology highly attractive to ObGyns who can now treat many patients 24/7 from their homes using laptops and even mobile devices. In addition, the pandemic has prompted an expansion of current procedural terminology (CPT) codes that makes it possible to bill patients for telemedicine services and be appropriately compensated.

Thus, as awful as COVID-19 is, we can conclude that it has provided us with opportunities. We predict that when the crisis has abated, although the current relaxation of HIPAA guidelines will probably be rescinded, restrictions will not likely return to precoronavirus status; changes will certainly be made, and telemedicine will likely become part and parcel of caring for ObGyn patients.

Telemedicine has been used successfully for years to improve patient access to medical care while reducing health care costs. In 2016, an estimated 61% of US health care institutions and 40% to 50% of US hospitals used telemedicine.⁶ And according to the results of a survey of America’s physicians conducted in April 2020, almost half (48%) are treating patients through telemedicine, which is up from just 18% 2 years ago.⁷

Letting loose the genie in the bottle

Widespread use of telemedicine traditionally has been limited by low reimbursement rates and interstate licensing and practice issues, but we predict that the use of telemedicine is going to significantly increase in the future. Here’s why:⁸ Disruptive innovation was defined by Professor Clayton Christensen of the Harvard Business School in 1997.⁹ Disruptive innovation explains the process by which a disruptive force spurs the development of simple, convenient, and affordable solutions that then replace processes that are expensive and complicated. According to Christensen, a critical element of the process is a technology that makes a product or service more accessible to a larger number of people while reducing cost and increasing ease of use. For example, innovations making equipment for dialysis cheaper and simpler helped make it possible to administer the treatment in neighborhood clinics, rather than in centralized hospitals, thus disrupting the hospital’s share of the dialysis business.

The concept of telemedicine and the technology for its implementation have been available for more than 15 years. However, it was the coronavirus that released the genie from the bottle, serving as the disruptive force to release the innovation. Telemedicine has demonstrated that the technology offers solutions that address patients’ urgent, unmet needs for access to care at an affordable price and that enhances the productivity of the ObGyn. The result is simple, convenient, and affordable; patients can readily access the medical care they need to effectively maintain their health or manage conditions that arise.

Telemedicine has reached a level of critical mass. Data suggest that patients, especially younger ones, have accepted and appreciate the use of this technology.¹⁰ It gives patients more opportunities to receive health care in their homes or at work where they feel more comfortable and less anxious than they do in physicians’ offices.

Several other health care issues may be altered by telemedicine.

The physician shortage. If the data are to be believed, there will be a significant shortage of physicians—and perhaps ObGyns—in the near future.¹¹ Telemedicine can help the problem by making it possible to provide medical care not only in rural areas where there are no ObGyns but also in urban areas where a shortage may be looming.

Continuing medical education (CME). CME is moving from large, expensive, in-person conferences to virtual conferences and online learning.

The American health care budget is bloated with expenses exceeding $3 trillion.¹² Telemedicine can help reduce health care costs by facilitating patient appointments that do not require office staff or many of the overhead expenses associated with brick and mortar operations. Telemedicine reduces the financial impact of patient no-shows. Because patients are keen on participating, the use of telemedicine likely will improve patient engagement and clinical outcomes. Telemedicine already has a reputation of reducing unnecessary office and emergency room visits and hospital admissions.¹³

Clinical trials. One of the obstacles to overcome in the early stages of a clinical trial is finding participants. Telemedicine will make patient recruitment more straightforward. And because telemedicine makes distance from the office a nonissue, recruiters will be less restricted by geographic boundaries.

In addition, telemedicine allows for the participants of the trial to stay in their homes most of the time while wearing remote monitoring devices. Such devices would enable trial researchers to spot deviations from patients’ baseline readings.

The bottom line

COVID-19 has provided the opportunity for us to see how telemedicine can contribute to reducing the spread of infectious diseases by protecting physicians, their staff, and patients themselves. Once the COVID-19 crisis has passed, it is likely that telemedicine will continue to move health care delivery from the hospital or clinic into the home. The growth and integration of information and communication technologies into health care delivery holds great potential for patients, providers, and payers in health systems of the future. ●

In the first 2 articles of this series, “Telemedicine: A primer for today’s ObGyn” and “Telemedicine: Common hurdles and proper coding for ObGyns,” which appeared in the May and June issues of OBG Management, we discussed caring for patients without face-to-face visits and that virtual visits are an opportunity to provide good care in a world such as that created by COVID-19. We also discussed which patients are the most appropriate candidates for telemedicine, as well as how to properly code virtual visits so that you are paid for your time and service. This third article addresses the legal concerns and caveats of using telemedicine and makes a prediction for the future of virtual health care.

Legal issues surrounding telemedicine

There are numerous legal, regulatory, and compliance issues that existed before the pandemic that likely will continue to be of concern postpandemic. Although the recent 1135 waiver (allowing Medicare to pay for office, hospital, and other visits furnished via telehealth)¹ and other regulations are now in place for almost every aspect of telemedicine, virtual medicine is not a free-for-all (even though it may seem like it). Practicing ethical telemedicine entails abiding by numerous federal and state-specific laws and requirements. It is important to be aware of the laws in each state in which your patients are located and to practice according to the requirements of these laws. This often requires consultation with an experienced health care attorney who is knowledgeable about the use of telemedicine and who can help you with issues surrounding:

• Malpractice insurance. It is an important first step to contact your practice’s malpractice insurance carrier and confirm coverage for telemedicine visits. Telemedicine visits are considered the same as in-person visits when determining scope of practice and malpractice liability. Nevertheless, a best practice is to have written verification from your malpractice carrier about the types of telemedicine services and claims for which your ObGyn practice is covered. Additionally, if you care for patients virtually who live in a state in which you are not licensed, check with your carrier to determine if potential claims will be covered.
• Corporate practice laws. These laws require that your practice be governed by a health care professional and not someone with a nonmedical background. This becomes important if you are looking to create a virtual practice in another state. States that prohibit the corporate practice of medicine have state-specific mandates that require strict adherence. Consult with a health care attorney before entering into a business arrangement with a nonphysician or corporate entity.
• Delegation agreement requirements. These laws require physician collaboration and/or supervision of allied health care workers such as nurse practitioners (NPs) and physician assistants (PAs) and may limit the number of allied health care providers that a physician may supervise. Many states are allowing allied health care workers to practice at the top of their license, but this is still state specific. Thus, it is an important issue to consider, especially for practices that rely heavily on the services of advanced practice registered nurses (APRNs), for example, who have a broad scope of practice and who may be qualified to care for many common ObGyn problems.
• Informed consent requirements. Some states have no requirements regarding consent for a virtual visit. Others require either written or verbal consent. In states that do not require informed consent, it is best practice to nevertheless obtain either written or oral consent and to document in the patient’s record that consent was obtained before initiating a virtual visit. The consent should follow state-mandated disclosures, as well as the practice’s policies regarding billing, scheduling, and cancellations of telemedicine visits.
• Interstate licensing laws. Because of the COVID-19 pandemic, federal and state licensure waivers are in place to allow physicians to care for patients outside the physician’s home state, but these waivers likely will be lifted postpandemic. Once waivers are lifted, physicians will need to be licensed not only in the state in which they practice but also in the state where the patient is located at the time of treatment. Even physicians who practice in states that belong to the Interstate Medical Licensure Compact² must apply for and obtain a license to practice within Compact member states. Membership in the Interstate Medical Licensure Compact expedites the licensure process, but does not alleviate the need to obtain a license to practice in each member state. To ensure compliance with interstate licensure laws, seek advice from a health care attorney specializing in telemedicine.
• Drug monitoring laws. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008³ implemented a requirement that physicians have at least one in-person, face-to-face visit with patients before prescribing a controlled substance for the first time. Because state laws may vary, we suggest consulting with a health care attorney to understand your state’s requirements for prescribing controlled substances to new patients and when using telemedicine (see “Prescription drugs” at https://www.cdc.gov/phlp/publications/topic/prescription.html for more information).
• Data privacy and security. From a content perspective, health care data and personally identifiable information are extremely rich, which makes electronic health records (EHRs), or the digital form of patients’ medical histories and other data, particularly tempting targets for hackers and cyber criminals. We caution that services such as Facetime and Skype are not encrypted; they have been granted waivers for telemedicine use, but these waivers are probably not going to be permanent once the COVID-19 crisis passes.
• HIPAA compliance. Generally—and certainly under normal circumstances—telemedicine is subject to the same rules governing protected health information (PHI) as any other technology and process used in physician practices. The Health Insurance Portability and Accountability Act (HIPAA) Security Rule includes guidelines on telemedicine and stipulates that only authorized users should have access to ePHI, that a system of secure communication must be established to protect the security of ePHI, and that a system to monitor communications must be maintained, among other requirements.⁴ Third parties that provide telemedicine, data storage, and other services, with a few exceptions, must have a business associate agreement (BAA) with a covered entity. Covered entities include health care providers, health plans, and health and health care clearinghouses. Such an agreement should include specific language that ensures that HIPAA requirements will be met and that governs permitted and required uses of PHI, strictly limits other uses of PHI, and establishes appropriate safeguards and steps that must be taken in the event of a breach or disallowed disclosure of PHI. Best practice requires that providers establish robust protocols, policies, and processes for handling sensitive information.

During the COVID-19 pandemic, however, certain HIPAA restrictions relating to telemedicine have been temporarily waived by the US Department of Health and Human Services (HHS). More specifically, HHS Secretary Alex Azar has exercised his authority to waive sanctions against covered hospitals for noncompliance with requirements: to obtain a patient’s consent to speak with family members or friends involved in the patient’s care, to distribute a notice of privacy practices, to request privacy restrictions, to request confidential communications, and the use of nonpublic facing audio and video communications products, among others.⁵ These are temporary measures only; once the national public health emergency has passed or at the HHS Secretary’s discretion based on new developments, this position on discretionary nonenforcement may end.

Continue to: Crisis creates opportunity: The future of telemedicine...

Crisis creates opportunity: The future of telemedicine

It was just a few years ago when the use of telemedicine was relegated to treating patients in only rural areas or those located a great distance from brick and mortar practices. But the pandemic, along with the coincident relaxation of the Centers for Medicare and Medicaid Services’ (CMS) requirements for conducting telemedicine visits has made the technology highly attractive to ObGyns who can now treat many patients 24/7 from their homes using laptops and even mobile devices. In addition, the pandemic has prompted an expansion of current procedural terminology (CPT) codes that makes it possible to bill patients for telemedicine services and be appropriately compensated.

Thus, as awful as COVID-19 is, we can conclude that it has provided us with opportunities. We predict that when the crisis has abated, although the current relaxation of HIPAA guidelines will probably be rescinded, restrictions will not likely return to precoronavirus status; changes will certainly be made, and telemedicine will likely become part and parcel of caring for ObGyn patients.

Telemedicine has been used successfully for years to improve patient access to medical care while reducing health care costs. In 2016, an estimated 61% of US health care institutions and 40% to 50% of US hospitals used telemedicine.⁶ And according to the results of a survey of America’s physicians conducted in April 2020, almost half (48%) are treating patients through telemedicine, which is up from just 18% 2 years ago.⁷

Letting loose the genie in the bottle

Widespread use of telemedicine traditionally has been limited by low reimbursement rates and interstate licensing and practice issues, but we predict that the use of telemedicine is going to significantly increase in the future. Here’s why:⁸ Disruptive innovation was defined by Professor Clayton Christensen of the Harvard Business School in 1997.⁹ Disruptive innovation explains the process by which a disruptive force spurs the development of simple, convenient, and affordable solutions that then replace processes that are expensive and complicated. According to Christensen, a critical element of the process is a technology that makes a product or service more accessible to a larger number of people while reducing cost and increasing ease of use. For example, innovations making equipment for dialysis cheaper and simpler helped make it possible to administer the treatment in neighborhood clinics, rather than in centralized hospitals, thus disrupting the hospital’s share of the dialysis business.

The concept of telemedicine and the technology for its implementation have been available for more than 15 years. However, it was the coronavirus that released the genie from the bottle, serving as the disruptive force to release the innovation. Telemedicine has demonstrated that the technology offers solutions that address patients’ urgent, unmet needs for access to care at an affordable price and that enhances the productivity of the ObGyn. The result is simple, convenient, and affordable; patients can readily access the medical care they need to effectively maintain their health or manage conditions that arise.

Telemedicine has reached a level of critical mass. Data suggest that patients, especially younger ones, have accepted and appreciate the use of this technology.¹⁰ It gives patients more opportunities to receive health care in their homes or at work where they feel more comfortable and less anxious than they do in physicians’ offices.

Several other health care issues may be altered by telemedicine.

The physician shortage. If the data are to be believed, there will be a significant shortage of physicians—and perhaps ObGyns—in the near future.¹¹ Telemedicine can help the problem by making it possible to provide medical care not only in rural areas where there are no ObGyns but also in urban areas where a shortage may be looming.

Continuing medical education (CME). CME is moving from large, expensive, in-person conferences to virtual conferences and online learning.

The American health care budget is bloated with expenses exceeding $3 trillion.¹² Telemedicine can help reduce health care costs by facilitating patient appointments that do not require office staff or many of the overhead expenses associated with brick and mortar operations. Telemedicine reduces the financial impact of patient no-shows. Because patients are keen on participating, the use of telemedicine likely will improve patient engagement and clinical outcomes. Telemedicine already has a reputation of reducing unnecessary office and emergency room visits and hospital admissions.¹³

Clinical trials. One of the obstacles to overcome in the early stages of a clinical trial is finding participants. Telemedicine will make patient recruitment more straightforward. And because telemedicine makes distance from the office a nonissue, recruiters will be less restricted by geographic boundaries.

In addition, telemedicine allows for the participants of the trial to stay in their homes most of the time while wearing remote monitoring devices. Such devices would enable trial researchers to spot deviations from patients’ baseline readings.

The bottom line

COVID-19 has provided the opportunity for us to see how telemedicine can contribute to reducing the spread of infectious diseases by protecting physicians, their staff, and patients themselves. Once the COVID-19 crisis has passed, it is likely that telemedicine will continue to move health care delivery from the hospital or clinic into the home. The growth and integration of information and communication technologies into health care delivery holds great potential for patients, providers, and payers in health systems of the future. ●

In the first 2 articles of this series, “Telemedicine: A primer for today’s ObGyn” and “Telemedicine: Common hurdles and proper coding for ObGyns,” which appeared in the May and June issues of OBG Management, we discussed caring for patients without face-to-face visits and that virtual visits are an opportunity to provide good care in a world such as that created by COVID-19. We also discussed which patients are the most appropriate candidates for telemedicine, as well as how to properly code virtual visits so that you are paid for your time and service. This third article addresses the legal concerns and caveats of using telemedicine and makes a prediction for the future of virtual health care.

Legal issues surrounding telemedicine

There are numerous legal, regulatory, and compliance issues that existed before the pandemic that likely will continue to be of concern postpandemic. Although the recent 1135 waiver (allowing Medicare to pay for office, hospital, and other visits furnished via telehealth)¹ and other regulations are now in place for almost every aspect of telemedicine, virtual medicine is not a free-for-all (even though it may seem like it). Practicing ethical telemedicine entails abiding by numerous federal and state-specific laws and requirements. It is important to be aware of the laws in each state in which your patients are located and to practice according to the requirements of these laws. This often requires consultation with an experienced health care attorney who is knowledgeable about the use of telemedicine and who can help you with issues surrounding:

• Malpractice insurance. It is an important first step to contact your practice’s malpractice insurance carrier and confirm coverage for telemedicine visits. Telemedicine visits are considered the same as in-person visits when determining scope of practice and malpractice liability. Nevertheless, a best practice is to have written verification from your malpractice carrier about the types of telemedicine services and claims for which your ObGyn practice is covered. Additionally, if you care for patients virtually who live in a state in which you are not licensed, check with your carrier to determine if potential claims will be covered.
• Corporate practice laws. These laws require that your practice be governed by a health care professional and not someone with a nonmedical background. This becomes important if you are looking to create a virtual practice in another state. States that prohibit the corporate practice of medicine have state-specific mandates that require strict adherence. Consult with a health care attorney before entering into a business arrangement with a nonphysician or corporate entity.
• Delegation agreement requirements. These laws require physician collaboration and/or supervision of allied health care workers such as nurse practitioners (NPs) and physician assistants (PAs) and may limit the number of allied health care providers that a physician may supervise. Many states are allowing allied health care workers to practice at the top of their license, but this is still state specific. Thus, it is an important issue to consider, especially for practices that rely heavily on the services of advanced practice registered nurses (APRNs), for example, who have a broad scope of practice and who may be qualified to care for many common ObGyn problems.
• Informed consent requirements. Some states have no requirements regarding consent for a virtual visit. Others require either written or verbal consent. In states that do not require informed consent, it is best practice to nevertheless obtain either written or oral consent and to document in the patient’s record that consent was obtained before initiating a virtual visit. The consent should follow state-mandated disclosures, as well as the practice’s policies regarding billing, scheduling, and cancellations of telemedicine visits.
• Interstate licensing laws. Because of the COVID-19 pandemic, federal and state licensure waivers are in place to allow physicians to care for patients outside the physician’s home state, but these waivers likely will be lifted postpandemic. Once waivers are lifted, physicians will need to be licensed not only in the state in which they practice but also in the state where the patient is located at the time of treatment. Even physicians who practice in states that belong to the Interstate Medical Licensure Compact² must apply for and obtain a license to practice within Compact member states. Membership in the Interstate Medical Licensure Compact expedites the licensure process, but does not alleviate the need to obtain a license to practice in each member state. To ensure compliance with interstate licensure laws, seek advice from a health care attorney specializing in telemedicine.
• Drug monitoring laws. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008³ implemented a requirement that physicians have at least one in-person, face-to-face visit with patients before prescribing a controlled substance for the first time. Because state laws may vary, we suggest consulting with a health care attorney to understand your state’s requirements for prescribing controlled substances to new patients and when using telemedicine (see “Prescription drugs” at https://www.cdc.gov/phlp/publications/topic/prescription.html for more information).
• Data privacy and security. From a content perspective, health care data and personally identifiable information are extremely rich, which makes electronic health records (EHRs), or the digital form of patients’ medical histories and other data, particularly tempting targets for hackers and cyber criminals. We caution that services such as Facetime and Skype are not encrypted; they have been granted waivers for telemedicine use, but these waivers are probably not going to be permanent once the COVID-19 crisis passes.
• HIPAA compliance. Generally—and certainly under normal circumstances—telemedicine is subject to the same rules governing protected health information (PHI) as any other technology and process used in physician practices. The Health Insurance Portability and Accountability Act (HIPAA) Security Rule includes guidelines on telemedicine and stipulates that only authorized users should have access to ePHI, that a system of secure communication must be established to protect the security of ePHI, and that a system to monitor communications must be maintained, among other requirements.⁴ Third parties that provide telemedicine, data storage, and other services, with a few exceptions, must have a business associate agreement (BAA) with a covered entity. Covered entities include health care providers, health plans, and health and health care clearinghouses. Such an agreement should include specific language that ensures that HIPAA requirements will be met and that governs permitted and required uses of PHI, strictly limits other uses of PHI, and establishes appropriate safeguards and steps that must be taken in the event of a breach or disallowed disclosure of PHI. Best practice requires that providers establish robust protocols, policies, and processes for handling sensitive information.

During the COVID-19 pandemic, however, certain HIPAA restrictions relating to telemedicine have been temporarily waived by the US Department of Health and Human Services (HHS). More specifically, HHS Secretary Alex Azar has exercised his authority to waive sanctions against covered hospitals for noncompliance with requirements: to obtain a patient’s consent to speak with family members or friends involved in the patient’s care, to distribute a notice of privacy practices, to request privacy restrictions, to request confidential communications, and the use of nonpublic facing audio and video communications products, among others.⁵ These are temporary measures only; once the national public health emergency has passed or at the HHS Secretary’s discretion based on new developments, this position on discretionary nonenforcement may end.

Continue to: Crisis creates opportunity: The future of telemedicine...

Crisis creates opportunity: The future of telemedicine

It was just a few years ago when the use of telemedicine was relegated to treating patients in only rural areas or those located a great distance from brick and mortar practices. But the pandemic, along with the coincident relaxation of the Centers for Medicare and Medicaid Services’ (CMS) requirements for conducting telemedicine visits has made the technology highly attractive to ObGyns who can now treat many patients 24/7 from their homes using laptops and even mobile devices. In addition, the pandemic has prompted an expansion of current procedural terminology (CPT) codes that makes it possible to bill patients for telemedicine services and be appropriately compensated.

Thus, as awful as COVID-19 is, we can conclude that it has provided us with opportunities. We predict that when the crisis has abated, although the current relaxation of HIPAA guidelines will probably be rescinded, restrictions will not likely return to precoronavirus status; changes will certainly be made, and telemedicine will likely become part and parcel of caring for ObGyn patients.

Telemedicine has been used successfully for years to improve patient access to medical care while reducing health care costs. In 2016, an estimated 61% of US health care institutions and 40% to 50% of US hospitals used telemedicine.⁶ And according to the results of a survey of America’s physicians conducted in April 2020, almost half (48%) are treating patients through telemedicine, which is up from just 18% 2 years ago.⁷

Letting loose the genie in the bottle

Widespread use of telemedicine traditionally has been limited by low reimbursement rates and interstate licensing and practice issues, but we predict that the use of telemedicine is going to significantly increase in the future. Here’s why:⁸ Disruptive innovation was defined by Professor Clayton Christensen of the Harvard Business School in 1997.⁹ Disruptive innovation explains the process by which a disruptive force spurs the development of simple, convenient, and affordable solutions that then replace processes that are expensive and complicated. According to Christensen, a critical element of the process is a technology that makes a product or service more accessible to a larger number of people while reducing cost and increasing ease of use. For example, innovations making equipment for dialysis cheaper and simpler helped make it possible to administer the treatment in neighborhood clinics, rather than in centralized hospitals, thus disrupting the hospital’s share of the dialysis business.

The concept of telemedicine and the technology for its implementation have been available for more than 15 years. However, it was the coronavirus that released the genie from the bottle, serving as the disruptive force to release the innovation. Telemedicine has demonstrated that the technology offers solutions that address patients’ urgent, unmet needs for access to care at an affordable price and that enhances the productivity of the ObGyn. The result is simple, convenient, and affordable; patients can readily access the medical care they need to effectively maintain their health or manage conditions that arise.

Telemedicine has reached a level of critical mass. Data suggest that patients, especially younger ones, have accepted and appreciate the use of this technology.¹⁰ It gives patients more opportunities to receive health care in their homes or at work where they feel more comfortable and less anxious than they do in physicians’ offices.

Several other health care issues may be altered by telemedicine.

The physician shortage. If the data are to be believed, there will be a significant shortage of physicians—and perhaps ObGyns—in the near future.¹¹ Telemedicine can help the problem by making it possible to provide medical care not only in rural areas where there are no ObGyns but also in urban areas where a shortage may be looming.

Continuing medical education (CME). CME is moving from large, expensive, in-person conferences to virtual conferences and online learning.

The American health care budget is bloated with expenses exceeding $3 trillion.¹² Telemedicine can help reduce health care costs by facilitating patient appointments that do not require office staff or many of the overhead expenses associated with brick and mortar operations. Telemedicine reduces the financial impact of patient no-shows. Because patients are keen on participating, the use of telemedicine likely will improve patient engagement and clinical outcomes. Telemedicine already has a reputation of reducing unnecessary office and emergency room visits and hospital admissions.¹³

Clinical trials. One of the obstacles to overcome in the early stages of a clinical trial is finding participants. Telemedicine will make patient recruitment more straightforward. And because telemedicine makes distance from the office a nonissue, recruiters will be less restricted by geographic boundaries.

In addition, telemedicine allows for the participants of the trial to stay in their homes most of the time while wearing remote monitoring devices. Such devices would enable trial researchers to spot deviations from patients’ baseline readings.

The bottom line

COVID-19 has provided the opportunity for us to see how telemedicine can contribute to reducing the spread of infectious diseases by protecting physicians, their staff, and patients themselves. Once the COVID-19 crisis has passed, it is likely that telemedicine will continue to move health care delivery from the hospital or clinic into the home. The growth and integration of information and communication technologies into health care delivery holds great potential for patients, providers, and payers in health systems of the future. ●

Since the COVID-19 pandemic began, many significant changes have occurred that have made the implementation of telemedicine easier and more attractive for gynecologic practices. In the first article in this series, we discussed the benefits of telemedicine to physicians and patients, how to get started using telemedicine, and implementing a workflow. This article will discuss the common hurdles in the process and the proper coding to use to insure reimbursement for services rendered.

Barriers to implementing telemedicine

Incorrect assumptions

Latecomers to telemedicine often assume that patients prefer face-to-face visits when, in fact, many may prefer the convenience of virtual visits. More than 50% of patients who are surveyed about their experience with telemedicine say that online tools have helped improve their relationship with their providers.¹ Telemedicine has grown astronomically during the COVID-19 pandemic to the point where many patients now expect their health care providers to be able to conduct virtual visits. Practices that do not offer telemedicine may find their patients seeking services elsewhere. Nearly two-thirds of health care professionals expect their commitment to telemedicine to increase significantly in the next 3 years.² Of those providers who have not yet adopted the practice, nearly 85% expect to implement telemedicine in the near future.³ COVID-19 has motivated the increased use of telemedicine to enhance the communication with patients, making it possible for patients to have enhanced access to health care during this pandemic while minimizing infectious transmission of COVID-19 to physicians and their staff.⁴

Admittedly, telemedicine is not appropriate for all patients. In general, situations that do not lend themselves to telemedicine are those for which an in-person visit is required to evaluate the patient via a physical examination, to perform a protocol-driven procedure, or provide an aggressive intervention. Additional patients for whom telemedicine may be inappropriate include those with cognitive disorders, those with language barriers, those with emergency situations that warrant an office visit or a visit to the emergency department, and patients who do not have access to the technology to conduct a virtual visit.

Cost and complexity

The process of implementing electronic health records (EHRs) left a bitter taste in the mouths of many health care professionals. But EHRs are complicated and expensive. Implementation often resulted in lost productivity. Because the learning curve was so steep, many physicians had to decrease the number of patients they saw before becoming comfortable with the conversion from paper charts to an EHR.

Telemedicine implementation is much less onerous and expensive. Telemedicine is available as a cloud-based platform, which requires less information technology (IT) support and less hardware and software. The technology required for patients to participate in telemedicine is nearly ubiquitous. According to the Pew Research Center, 96% of Americans own a cell phone (81% have a smart phone), and more than half (52%) own a tablet, so the basic equipment to connect patients to providers is already in place.⁵

On the provider side, the basic equipment required for a telemedicine program is a computer with video and audio capabilities and a broadband connection that is fast enough to show video in real time and to provide high-quality viewing of any images to be reviewed.

The growth in telemedicine means that telemedicine options are now more diverse, with many more affordable solutions. However, most telemedicine programs do require the purchase and set-up of new technology and equipment and the training of staff—some of which may be outside the budgets of health care providers in smaller independent practices. Many gynecologists have technology budgets that are already stretched thin. And for patients who do not have access to a smartphone or computer with Internet access, real-time telemedicine may be out of reach.

But with new guidelines put forth by the Centers for Medicare and Medicaid Services (CMS) in March 2020, connectivity can take place inexpensively using free platforms such as Google Hangouts, Skype, Facetime, and Facebook Messenger. If a non‒HIPAA-compliant platform is used initially, conversion to a HIPAA-compliant platform is recommended.⁶ These platforms do not require the purchase of, or subscription to, any expensive hardware or software. The disadvantages of these programs are the lack of documentation, the failure to be Health Insurance Portability and Accountability Act (HIPAA)-compliant, and the lack of encryption; however, these disadvantages are no longer an issue after the new CMS guidelines.

Depending on the magnitude of the program, IT assistance may be needed to get started. It is imperative that the telemedicine program is interoperable with the EHR and the billing program. Otherwise, double and triple entry will erase the efficiency provided by conducting a virtual visit.

Continue to: Licensing...

Licensing

Another concern or barrier is a license to participate in telemedicine. The March 15, 2020, approval of telemedicine states that physicians who are licensed in the state where the patient is located do not require any additional license or permission to conduct virtual visits.⁷ CMS has temporarily waived the requirement that out-of-state providers be licensed in the state where they are providing services when they are licensed in another state. For questions regarding licensure, contact your State Board of Medicine or Department of Health for information on requirements for licenses across state lines (see “Resources,” at the end of the article).

Informed consent

Just like with any other aspect of providing care for patients, obtaining informed consent is paramount. Not only is getting informed patient consent a recommended best practice of the American Telemedicine Association (ATA), but it is actually a legal requirement in many states and could be a condition of getting paid, depending on the payer. To check the requirements regarding patient consent in your state, look at The National Telehealth Policy Resource Center’s state map (see “Resources.")

Some states do not have any requirements regarding consent for a virtual visit. Others require verbal consent. Even if it is not a legal requirement in your state, consider making it a part of your practice’s policy to obtain written or verbal consent and to document in the patient’s record that consent was obtained prior to the virtual visit so that you are protected when using this new technology.

Because telemedicine is a new way of receiving care for many patients, it is important to let them know how it works including how patient confidentiality and privacy are handled, what technical equipment is required, and what they should expect in terms of scheduling, cancellations, and billing policies. A sample consent form for telemedicine use is shown in FIGURE 1.

Liability insurance

Another hurdle that must be considered is liability insurance for conducting virtual visits with patients. Gynecologists who are going to offer telemedicine care to patients should request proof in writing that their liability insurance policy covers telemedicine malpractice and that the coverage extends to other states should the patient be in another state from the state in which the gynecologist holds a license. Additionally, gynecologists who provide telemedicine care should check with liability insurers regarding any requirements or limitations to conducting a virtual visit with their patients and should document them. For example, the policy may require that the physician keep a written or recorded record of the visit in the EHR. If that is the case, then using Skype, Facebook, or Google for the virtual visit, which do not include documentation, would be less desirable.

Privacy

Certainly, there is concern about privacy, and HIPAA compliance is critical to telemedicine success. Because of the COVID-19 emergency, as of March 1, 2020, physicians may now communicate with patients, and provide telehealth services, through remote communications without penalties.⁸ With these changes in the HIPAA requirements, physicians may use applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, and Skype, to provide telehealth without risk that the Office for Civil Rights will impose a penalty for noncompliance with HIPAA rules. The consent for patients should mention that these “public” applications potentially introduce privacy risks. This is a motivation for gynecologists to consider one of the programs that promises encryption, privacy, and HIPAA compliance, such as Updox, Doxy.me, and Amazon Chime. It is also important to recognize that a virtual visit could result in colleagues (if the patient is in an office setting) or family members (if the patient is in the home environment) overhearing conversations between the health care professional and the patient. Therefore, we suggest that patients conduct virtual visits in locations in which they feel assured of some semblance of privacy.

Continue to: Compensation for telemedicine...

Compensation for telemedicine

Perhaps the biggest barrier to virtual health adoption has been compensation for telemedicine visits. Both commercial payers and CMS have been slow to enact formal policies for telemedicine reimbursement. Because of this, the common misconceptions (that providers cannot be reimbursed for telemedicine appointments or that compensation occurs at a reduced rate) have persisted, making telemedicine economically unappealing.

The good news is that this is changing; legislation in most states is quickly embracing virtual health visits as a result of the COVID-19 pandemic.⁹ In fact, as of January 1, 2020, telemedicine services are no longer considered “optional” coverage in Medicare Advantage plans.¹⁰ Nor are they required to have an additional fee. Instead, CMS now allows telemedicine as a standard, covered benefit in all plans, enabling beneficiaries to seek care from their homes rather than requiring them to go to a health care facility.¹¹ In the past, telemedicine was restricted for use in rural areas or when patients resided a great distance from their health care providers. Starting March 6, 2020, and for the duration of the COVID-19 public health emergency, Medicare will make payment for professional services furnished to beneficiaries in all areas of the country in all settings regardless of location or distance between the patient and the health care provider.¹²

In addition, since March 15, 2020, CMS has expanded access to telemedicine services for all Medicare beneficiaries—not just those who have been diagnosed with COVID-19.¹³ The expanded access also applies to pre-COVID-19 coverage from physician offices, skilled nursing facilities, and hospitals. This means that Medicare will now make payments to physicians for telemedicine services provided in any health care facility or in a patient’s home, so that patients do not need to go to the physician’s office.

The facts are that there are parity laws and that commercial payers and CMS are required by state law to reimburse for telemedicine—often at the same rate as that for a comparable in-person visit. On the commercial side, there has been an increase in commercial parity legislation that requires health plans to cover virtual visits in the same way they cover face-to-face services. With the new guidelines for reimbursement, every state and Washington DC has parity laws in place. (To stay abreast of state-by-state changes in virtual health reimbursement, the Center for Connected Health Policy and the Advisory Board Primer are valuable resources. See “Resources.”) As long as the provider performs and documents the elements of history and decision-making, including the time spent counseling, and documents the visit as if a face-to-face visit occurred, then clinicians have a billable evaluation and management (E&M) visit.

Continue to: Virtual services for Medicare patients...

Virtual services for Medicare patients

There are 3 main types of virtual services gynecologists can provide to Medicare patients: Medicare telehealth visits, virtual check-ins, and e-visits.

Medicare telehealth visits. Largely because of the COVID-19 pandemic, Medicare patients may now use telecommunication technology for any services that previously occurred in an in-person communication. The gynecologist must use an interactive audio and video telecommunications system that permits real-time communication between the physician and the patient, and the patient should have a prior established relationship with the gynecologist with whom the telemedicine visit is taking place. The new guidelines indicate that the US Department of Health and Human Services (HHS) will not conduct audits to ensure that such a prior relationship exists for claims submitted during this public health emergency.¹⁴

The Current Procedural Terminology (CPT) codes for virtual visits using synchronous audio/visual communication are:

• 99201-99295, Office visit for a new patient
• 99211-99215, Office visit for an established patient.

Important modifiers for telemedicine visits include:

• modifier 02 for POS (place of service) for telehealth Medicare
• modifier 95 for commercial payers.

(A list of all available CPT codes for telehealth services from CMS can be found in “Resources.”)

Virtual check-ins. Established Medicare patients may have a brief communication with gynecologists the traditional way using a telephone or via live video. These brief virtual services, usually 5 to 10 minutes in duration, are initiated by the patient. The purpose of the virtual check-in is to determine if an office visit or a test or procedure is indicated.

Medicare pays for these “virtual check-ins” (or brief communication technology-based services) for patients to communicate with their physicians and avoid unnecessary trips to the office. These brief virtual check-ins are only for established patients. If an existing patient contacts the gynecologist’s office to ask a question or determine if an office visit is necessary, the gynecologist may bill for it using code G2012.

E-visits. Established Medicare patients may have non–face-to-face patient-initiated communications with their gynecologists without going to the physician’s office. These services can be billed only when the physician has an established relationship with the patient. The services may be billed using CPT codes 99421 to 99423. Coding for these visits is determined by the length of time the gynecologist spends online with the patient:

• 99421: Online digital evaluation and management service, for an established patient 5 to 10 minutes spent on the virtual visit
• 99422: 11 to 20 minutes
• 99423: ≥ 21 minutes.

Many clinicians want to immediately start the communication process with their patients. Many will avail themselves of the free video communication offered by Google Hangouts, Skype, Facetime, and Facebook Messenger. Since the March 15, 2020, relaxation of the HIPAA restrictions for telemedicine, it is now possible to have a virtual visit with a patient using one of the free, non–HIPAA-compliant connections. This type of visit is no different than a telephone call but with an added video component. Using these free technologies, a gynecologist can have an asynchronous visit with a patient (referred to as the store and forward method of sending information or medical images), which means that the service takes place in one direction with no opportunity for interaction with the patient. Asynchronous visits are akin to video text messages left for the patient. By contrast, a synchronous or real-time video visit with a patient is a 2-way communication that provides medical care without examining the patient.

Using triangulation

There are some downsides to telemedicine visits. First, virtual visits on Skype, FaceTime, and other non–HIPAA-compliant methods are not conducted on an encrypted website. Second, no documentation is created for the doctor-patient encounter. Finally, unless the physician keeps a record of these virtual visits and submits the interactions to the practice coders, there will be no billing and no reimbursement for the visits. In this scenario, physicians are legally responsible for their decision-making, prescription writing, and medical advice, but do not receive compensation for their efforts.

This can be remedied by using “triangulation,” which involves: 1. the physician, 2. the patient, and 3. a scribe or medical assistant who will record the visit. Before initiating the virtual visit using triangulation, it is imperative to ask the patient for permission if your medical assistant (or any other person in the office who functions as a scribe) will be listening to the conversation. It is important to explain that the person is there to take accurate notes and ascertain that the notes are entered into the EHR. Also, the scribe or assistant will record the time, date, and duration of the visit, which is a requirement for billing purposes. The scribe may also ascertain that the visit is properly coded and entered into the practice management system, and that a bill is submitted to the insurance company. By using triangulation, you have documentation that consent was obtained, that the visit took place, that notes were taken, and that the patient’s insurance company will be billed for the visit (see FIGURE 2 for a sample documentation form).

Continue to: Which CPT codes should I use?...

Which CPT codes should I use?

The answer depends on a number of factors, but a good rule of thumb is to use the same codes that you would use for an in-person appointment (CPT codes 99211-99215 for an established patient visit and 99201-99205 for a new patient visit). These are the most common CPT codes for outpatient gynecologic office visits whether they take place face-to-face or as a synchronous virtual visit (via a real-time interactive audio and video telecommunications system).

For example, the reimbursement for code 99213 has a range from $73 to $100. You may wonder how you can achieve the complexity requirements for a level-3 office visit without a physical examination. Whether as a face-to-face or virtual visit, documentation for these encounters requires 2 of 3 of the following components:

• expanded problem-focused history
• expanded problem-focused exam (not accomplished with telemedicine)
• low-complexity medical decision-making OR
• at least 15 minutes spent face to face with the patient if coding is based on time.

If a gynecologist reviews the results of a recent lab test for an estrogen-deficient patient and adjusts the estrogen dosage, writes a prescription, and spends 15 minutes communicating with the patient, he/she has met the complexity requirements for a code 99213. Because Level 3 and 4 visits (99214 and 99215) require a comprehensive physical examination, it is necessary to document the time spent with the patient (code 99214 requires 25 to 39 minutes of consultation and code 99215 requires ≥ 40 minutes).

Some final billing and coding advice

Always confirm telemedicine billing guidelines before beginning to conduct telemedicine visits. Consider starting a phone call to a payer armed with the fact that the payer is required by law to offer parity between telemedicine and face-to-face visits. Then ask which specific billing codes should be used.

Until you and your practice become comfortable with the process of, and the coding and billing for, telemedicine, consider using a telemedicine platform that has a built-in rules engine that offers recommendations for each telemedicine visit based on past claims data. These systems help gynecologists determine which CPT code to use and which modifiers are appropriate for the various insurance companies. In other words, the rules engine helps you submit a clean claim that is less likely to be denied and very likely to be paid. There are some vendors who are so confident that their rules engine will match the service with the proper CPT code and modifier that they guarantee full private payer reimbursement for telemedicine visits, or the vendor will reimburse the claim.

Watch for the third and final installment in this series, which was written with the assistance of 2 attorneys. It will review the legal guidelines for implementing telemedicine in a gynecologic practice and discuss the future of the technology. ●

Since the COVID-19 pandemic began, many significant changes have occurred that have made the implementation of telemedicine easier and more attractive for gynecologic practices. In the first article in this series, we discussed the benefits of telemedicine to physicians and patients, how to get started using telemedicine, and implementing a workflow. This article will discuss the common hurdles in the process and the proper coding to use to insure reimbursement for services rendered.

Barriers to implementing telemedicine

Incorrect assumptions

Latecomers to telemedicine often assume that patients prefer face-to-face visits when, in fact, many may prefer the convenience of virtual visits. More than 50% of patients who are surveyed about their experience with telemedicine say that online tools have helped improve their relationship with their providers.¹ Telemedicine has grown astronomically during the COVID-19 pandemic to the point where many patients now expect their health care providers to be able to conduct virtual visits. Practices that do not offer telemedicine may find their patients seeking services elsewhere. Nearly two-thirds of health care professionals expect their commitment to telemedicine to increase significantly in the next 3 years.² Of those providers who have not yet adopted the practice, nearly 85% expect to implement telemedicine in the near future.³ COVID-19 has motivated the increased use of telemedicine to enhance the communication with patients, making it possible for patients to have enhanced access to health care during this pandemic while minimizing infectious transmission of COVID-19 to physicians and their staff.⁴

Admittedly, telemedicine is not appropriate for all patients. In general, situations that do not lend themselves to telemedicine are those for which an in-person visit is required to evaluate the patient via a physical examination, to perform a protocol-driven procedure, or provide an aggressive intervention. Additional patients for whom telemedicine may be inappropriate include those with cognitive disorders, those with language barriers, those with emergency situations that warrant an office visit or a visit to the emergency department, and patients who do not have access to the technology to conduct a virtual visit.

Cost and complexity

The process of implementing electronic health records (EHRs) left a bitter taste in the mouths of many health care professionals. But EHRs are complicated and expensive. Implementation often resulted in lost productivity. Because the learning curve was so steep, many physicians had to decrease the number of patients they saw before becoming comfortable with the conversion from paper charts to an EHR.

Telemedicine implementation is much less onerous and expensive. Telemedicine is available as a cloud-based platform, which requires less information technology (IT) support and less hardware and software. The technology required for patients to participate in telemedicine is nearly ubiquitous. According to the Pew Research Center, 96% of Americans own a cell phone (81% have a smart phone), and more than half (52%) own a tablet, so the basic equipment to connect patients to providers is already in place.⁵

On the provider side, the basic equipment required for a telemedicine program is a computer with video and audio capabilities and a broadband connection that is fast enough to show video in real time and to provide high-quality viewing of any images to be reviewed.

The growth in telemedicine means that telemedicine options are now more diverse, with many more affordable solutions. However, most telemedicine programs do require the purchase and set-up of new technology and equipment and the training of staff—some of which may be outside the budgets of health care providers in smaller independent practices. Many gynecologists have technology budgets that are already stretched thin. And for patients who do not have access to a smartphone or computer with Internet access, real-time telemedicine may be out of reach.

But with new guidelines put forth by the Centers for Medicare and Medicaid Services (CMS) in March 2020, connectivity can take place inexpensively using free platforms such as Google Hangouts, Skype, Facetime, and Facebook Messenger. If a non‒HIPAA-compliant platform is used initially, conversion to a HIPAA-compliant platform is recommended.⁶ These platforms do not require the purchase of, or subscription to, any expensive hardware or software. The disadvantages of these programs are the lack of documentation, the failure to be Health Insurance Portability and Accountability Act (HIPAA)-compliant, and the lack of encryption; however, these disadvantages are no longer an issue after the new CMS guidelines.

Depending on the magnitude of the program, IT assistance may be needed to get started. It is imperative that the telemedicine program is interoperable with the EHR and the billing program. Otherwise, double and triple entry will erase the efficiency provided by conducting a virtual visit.

Continue to: Licensing...

Licensing

Another concern or barrier is a license to participate in telemedicine. The March 15, 2020, approval of telemedicine states that physicians who are licensed in the state where the patient is located do not require any additional license or permission to conduct virtual visits.⁷ CMS has temporarily waived the requirement that out-of-state providers be licensed in the state where they are providing services when they are licensed in another state. For questions regarding licensure, contact your State Board of Medicine or Department of Health for information on requirements for licenses across state lines (see “Resources,” at the end of the article).

Informed consent

Just like with any other aspect of providing care for patients, obtaining informed consent is paramount. Not only is getting informed patient consent a recommended best practice of the American Telemedicine Association (ATA), but it is actually a legal requirement in many states and could be a condition of getting paid, depending on the payer. To check the requirements regarding patient consent in your state, look at The National Telehealth Policy Resource Center’s state map (see “Resources.")

Some states do not have any requirements regarding consent for a virtual visit. Others require verbal consent. Even if it is not a legal requirement in your state, consider making it a part of your practice’s policy to obtain written or verbal consent and to document in the patient’s record that consent was obtained prior to the virtual visit so that you are protected when using this new technology.

Because telemedicine is a new way of receiving care for many patients, it is important to let them know how it works including how patient confidentiality and privacy are handled, what technical equipment is required, and what they should expect in terms of scheduling, cancellations, and billing policies. A sample consent form for telemedicine use is shown in FIGURE 1.

Liability insurance

Another hurdle that must be considered is liability insurance for conducting virtual visits with patients. Gynecologists who are going to offer telemedicine care to patients should request proof in writing that their liability insurance policy covers telemedicine malpractice and that the coverage extends to other states should the patient be in another state from the state in which the gynecologist holds a license. Additionally, gynecologists who provide telemedicine care should check with liability insurers regarding any requirements or limitations to conducting a virtual visit with their patients and should document them. For example, the policy may require that the physician keep a written or recorded record of the visit in the EHR. If that is the case, then using Skype, Facebook, or Google for the virtual visit, which do not include documentation, would be less desirable.

Privacy

Certainly, there is concern about privacy, and HIPAA compliance is critical to telemedicine success. Because of the COVID-19 emergency, as of March 1, 2020, physicians may now communicate with patients, and provide telehealth services, through remote communications without penalties.⁸ With these changes in the HIPAA requirements, physicians may use applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, and Skype, to provide telehealth without risk that the Office for Civil Rights will impose a penalty for noncompliance with HIPAA rules. The consent for patients should mention that these “public” applications potentially introduce privacy risks. This is a motivation for gynecologists to consider one of the programs that promises encryption, privacy, and HIPAA compliance, such as Updox, Doxy.me, and Amazon Chime. It is also important to recognize that a virtual visit could result in colleagues (if the patient is in an office setting) or family members (if the patient is in the home environment) overhearing conversations between the health care professional and the patient. Therefore, we suggest that patients conduct virtual visits in locations in which they feel assured of some semblance of privacy.

Continue to: Compensation for telemedicine...

Compensation for telemedicine

Perhaps the biggest barrier to virtual health adoption has been compensation for telemedicine visits. Both commercial payers and CMS have been slow to enact formal policies for telemedicine reimbursement. Because of this, the common misconceptions (that providers cannot be reimbursed for telemedicine appointments or that compensation occurs at a reduced rate) have persisted, making telemedicine economically unappealing.

The good news is that this is changing; legislation in most states is quickly embracing virtual health visits as a result of the COVID-19 pandemic.⁹ In fact, as of January 1, 2020, telemedicine services are no longer considered “optional” coverage in Medicare Advantage plans.¹⁰ Nor are they required to have an additional fee. Instead, CMS now allows telemedicine as a standard, covered benefit in all plans, enabling beneficiaries to seek care from their homes rather than requiring them to go to a health care facility.¹¹ In the past, telemedicine was restricted for use in rural areas or when patients resided a great distance from their health care providers. Starting March 6, 2020, and for the duration of the COVID-19 public health emergency, Medicare will make payment for professional services furnished to beneficiaries in all areas of the country in all settings regardless of location or distance between the patient and the health care provider.¹²

In addition, since March 15, 2020, CMS has expanded access to telemedicine services for all Medicare beneficiaries—not just those who have been diagnosed with COVID-19.¹³ The expanded access also applies to pre-COVID-19 coverage from physician offices, skilled nursing facilities, and hospitals. This means that Medicare will now make payments to physicians for telemedicine services provided in any health care facility or in a patient’s home, so that patients do not need to go to the physician’s office.

The facts are that there are parity laws and that commercial payers and CMS are required by state law to reimburse for telemedicine—often at the same rate as that for a comparable in-person visit. On the commercial side, there has been an increase in commercial parity legislation that requires health plans to cover virtual visits in the same way they cover face-to-face services. With the new guidelines for reimbursement, every state and Washington DC has parity laws in place. (To stay abreast of state-by-state changes in virtual health reimbursement, the Center for Connected Health Policy and the Advisory Board Primer are valuable resources. See “Resources.”) As long as the provider performs and documents the elements of history and decision-making, including the time spent counseling, and documents the visit as if a face-to-face visit occurred, then clinicians have a billable evaluation and management (E&M) visit.

Continue to: Virtual services for Medicare patients...

Virtual services for Medicare patients

There are 3 main types of virtual services gynecologists can provide to Medicare patients: Medicare telehealth visits, virtual check-ins, and e-visits.

Medicare telehealth visits. Largely because of the COVID-19 pandemic, Medicare patients may now use telecommunication technology for any services that previously occurred in an in-person communication. The gynecologist must use an interactive audio and video telecommunications system that permits real-time communication between the physician and the patient, and the patient should have a prior established relationship with the gynecologist with whom the telemedicine visit is taking place. The new guidelines indicate that the US Department of Health and Human Services (HHS) will not conduct audits to ensure that such a prior relationship exists for claims submitted during this public health emergency.¹⁴

The Current Procedural Terminology (CPT) codes for virtual visits using synchronous audio/visual communication are:

• 99201-99295, Office visit for a new patient
• 99211-99215, Office visit for an established patient.

Important modifiers for telemedicine visits include:

• modifier 02 for POS (place of service) for telehealth Medicare
• modifier 95 for commercial payers.

(A list of all available CPT codes for telehealth services from CMS can be found in “Resources.”)

Virtual check-ins. Established Medicare patients may have a brief communication with gynecologists the traditional way using a telephone or via live video. These brief virtual services, usually 5 to 10 minutes in duration, are initiated by the patient. The purpose of the virtual check-in is to determine if an office visit or a test or procedure is indicated.

Medicare pays for these “virtual check-ins” (or brief communication technology-based services) for patients to communicate with their physicians and avoid unnecessary trips to the office. These brief virtual check-ins are only for established patients. If an existing patient contacts the gynecologist’s office to ask a question or determine if an office visit is necessary, the gynecologist may bill for it using code G2012.

E-visits. Established Medicare patients may have non–face-to-face patient-initiated communications with their gynecologists without going to the physician’s office. These services can be billed only when the physician has an established relationship with the patient. The services may be billed using CPT codes 99421 to 99423. Coding for these visits is determined by the length of time the gynecologist spends online with the patient:

• 99421: Online digital evaluation and management service, for an established patient 5 to 10 minutes spent on the virtual visit
• 99422: 11 to 20 minutes
• 99423: ≥ 21 minutes.

Many clinicians want to immediately start the communication process with their patients. Many will avail themselves of the free video communication offered by Google Hangouts, Skype, Facetime, and Facebook Messenger. Since the March 15, 2020, relaxation of the HIPAA restrictions for telemedicine, it is now possible to have a virtual visit with a patient using one of the free, non–HIPAA-compliant connections. This type of visit is no different than a telephone call but with an added video component. Using these free technologies, a gynecologist can have an asynchronous visit with a patient (referred to as the store and forward method of sending information or medical images), which means that the service takes place in one direction with no opportunity for interaction with the patient. Asynchronous visits are akin to video text messages left for the patient. By contrast, a synchronous or real-time video visit with a patient is a 2-way communication that provides medical care without examining the patient.

Using triangulation

There are some downsides to telemedicine visits. First, virtual visits on Skype, FaceTime, and other non–HIPAA-compliant methods are not conducted on an encrypted website. Second, no documentation is created for the doctor-patient encounter. Finally, unless the physician keeps a record of these virtual visits and submits the interactions to the practice coders, there will be no billing and no reimbursement for the visits. In this scenario, physicians are legally responsible for their decision-making, prescription writing, and medical advice, but do not receive compensation for their efforts.

This can be remedied by using “triangulation,” which involves: 1. the physician, 2. the patient, and 3. a scribe or medical assistant who will record the visit. Before initiating the virtual visit using triangulation, it is imperative to ask the patient for permission if your medical assistant (or any other person in the office who functions as a scribe) will be listening to the conversation. It is important to explain that the person is there to take accurate notes and ascertain that the notes are entered into the EHR. Also, the scribe or assistant will record the time, date, and duration of the visit, which is a requirement for billing purposes. The scribe may also ascertain that the visit is properly coded and entered into the practice management system, and that a bill is submitted to the insurance company. By using triangulation, you have documentation that consent was obtained, that the visit took place, that notes were taken, and that the patient’s insurance company will be billed for the visit (see FIGURE 2 for a sample documentation form).

Continue to: Which CPT codes should I use?...

Which CPT codes should I use?

The answer depends on a number of factors, but a good rule of thumb is to use the same codes that you would use for an in-person appointment (CPT codes 99211-99215 for an established patient visit and 99201-99205 for a new patient visit). These are the most common CPT codes for outpatient gynecologic office visits whether they take place face-to-face or as a synchronous virtual visit (via a real-time interactive audio and video telecommunications system).

For example, the reimbursement for code 99213 has a range from $73 to $100. You may wonder how you can achieve the complexity requirements for a level-3 office visit without a physical examination. Whether as a face-to-face or virtual visit, documentation for these encounters requires 2 of 3 of the following components:

• expanded problem-focused history
• expanded problem-focused exam (not accomplished with telemedicine)
• low-complexity medical decision-making OR
• at least 15 minutes spent face to face with the patient if coding is based on time.

If a gynecologist reviews the results of a recent lab test for an estrogen-deficient patient and adjusts the estrogen dosage, writes a prescription, and spends 15 minutes communicating with the patient, he/she has met the complexity requirements for a code 99213. Because Level 3 and 4 visits (99214 and 99215) require a comprehensive physical examination, it is necessary to document the time spent with the patient (code 99214 requires 25 to 39 minutes of consultation and code 99215 requires ≥ 40 minutes).

Some final billing and coding advice

Always confirm telemedicine billing guidelines before beginning to conduct telemedicine visits. Consider starting a phone call to a payer armed with the fact that the payer is required by law to offer parity between telemedicine and face-to-face visits. Then ask which specific billing codes should be used.

Until you and your practice become comfortable with the process of, and the coding and billing for, telemedicine, consider using a telemedicine platform that has a built-in rules engine that offers recommendations for each telemedicine visit based on past claims data. These systems help gynecologists determine which CPT code to use and which modifiers are appropriate for the various insurance companies. In other words, the rules engine helps you submit a clean claim that is less likely to be denied and very likely to be paid. There are some vendors who are so confident that their rules engine will match the service with the proper CPT code and modifier that they guarantee full private payer reimbursement for telemedicine visits, or the vendor will reimburse the claim.

Watch for the third and final installment in this series, which was written with the assistance of 2 attorneys. It will review the legal guidelines for implementing telemedicine in a gynecologic practice and discuss the future of the technology. ●

Since the COVID-19 pandemic began, many significant changes have occurred that have made the implementation of telemedicine easier and more attractive for gynecologic practices. In the first article in this series, we discussed the benefits of telemedicine to physicians and patients, how to get started using telemedicine, and implementing a workflow. This article will discuss the common hurdles in the process and the proper coding to use to insure reimbursement for services rendered.

Barriers to implementing telemedicine

Incorrect assumptions

Latecomers to telemedicine often assume that patients prefer face-to-face visits when, in fact, many may prefer the convenience of virtual visits. More than 50% of patients who are surveyed about their experience with telemedicine say that online tools have helped improve their relationship with their providers.¹ Telemedicine has grown astronomically during the COVID-19 pandemic to the point where many patients now expect their health care providers to be able to conduct virtual visits. Practices that do not offer telemedicine may find their patients seeking services elsewhere. Nearly two-thirds of health care professionals expect their commitment to telemedicine to increase significantly in the next 3 years.² Of those providers who have not yet adopted the practice, nearly 85% expect to implement telemedicine in the near future.³ COVID-19 has motivated the increased use of telemedicine to enhance the communication with patients, making it possible for patients to have enhanced access to health care during this pandemic while minimizing infectious transmission of COVID-19 to physicians and their staff.⁴

Admittedly, telemedicine is not appropriate for all patients. In general, situations that do not lend themselves to telemedicine are those for which an in-person visit is required to evaluate the patient via a physical examination, to perform a protocol-driven procedure, or provide an aggressive intervention. Additional patients for whom telemedicine may be inappropriate include those with cognitive disorders, those with language barriers, those with emergency situations that warrant an office visit or a visit to the emergency department, and patients who do not have access to the technology to conduct a virtual visit.

Cost and complexity

The process of implementing electronic health records (EHRs) left a bitter taste in the mouths of many health care professionals. But EHRs are complicated and expensive. Implementation often resulted in lost productivity. Because the learning curve was so steep, many physicians had to decrease the number of patients they saw before becoming comfortable with the conversion from paper charts to an EHR.

Telemedicine implementation is much less onerous and expensive. Telemedicine is available as a cloud-based platform, which requires less information technology (IT) support and less hardware and software. The technology required for patients to participate in telemedicine is nearly ubiquitous. According to the Pew Research Center, 96% of Americans own a cell phone (81% have a smart phone), and more than half (52%) own a tablet, so the basic equipment to connect patients to providers is already in place.⁵

On the provider side, the basic equipment required for a telemedicine program is a computer with video and audio capabilities and a broadband connection that is fast enough to show video in real time and to provide high-quality viewing of any images to be reviewed.

The growth in telemedicine means that telemedicine options are now more diverse, with many more affordable solutions. However, most telemedicine programs do require the purchase and set-up of new technology and equipment and the training of staff—some of which may be outside the budgets of health care providers in smaller independent practices. Many gynecologists have technology budgets that are already stretched thin. And for patients who do not have access to a smartphone or computer with Internet access, real-time telemedicine may be out of reach.

But with new guidelines put forth by the Centers for Medicare and Medicaid Services (CMS) in March 2020, connectivity can take place inexpensively using free platforms such as Google Hangouts, Skype, Facetime, and Facebook Messenger. If a non‒HIPAA-compliant platform is used initially, conversion to a HIPAA-compliant platform is recommended.⁶ These platforms do not require the purchase of, or subscription to, any expensive hardware or software. The disadvantages of these programs are the lack of documentation, the failure to be Health Insurance Portability and Accountability Act (HIPAA)-compliant, and the lack of encryption; however, these disadvantages are no longer an issue after the new CMS guidelines.

Depending on the magnitude of the program, IT assistance may be needed to get started. It is imperative that the telemedicine program is interoperable with the EHR and the billing program. Otherwise, double and triple entry will erase the efficiency provided by conducting a virtual visit.

Continue to: Licensing...

Licensing

Another concern or barrier is a license to participate in telemedicine. The March 15, 2020, approval of telemedicine states that physicians who are licensed in the state where the patient is located do not require any additional license or permission to conduct virtual visits.⁷ CMS has temporarily waived the requirement that out-of-state providers be licensed in the state where they are providing services when they are licensed in another state. For questions regarding licensure, contact your State Board of Medicine or Department of Health for information on requirements for licenses across state lines (see “Resources,” at the end of the article).

Informed consent

Just like with any other aspect of providing care for patients, obtaining informed consent is paramount. Not only is getting informed patient consent a recommended best practice of the American Telemedicine Association (ATA), but it is actually a legal requirement in many states and could be a condition of getting paid, depending on the payer. To check the requirements regarding patient consent in your state, look at The National Telehealth Policy Resource Center’s state map (see “Resources.")

Some states do not have any requirements regarding consent for a virtual visit. Others require verbal consent. Even if it is not a legal requirement in your state, consider making it a part of your practice’s policy to obtain written or verbal consent and to document in the patient’s record that consent was obtained prior to the virtual visit so that you are protected when using this new technology.

Because telemedicine is a new way of receiving care for many patients, it is important to let them know how it works including how patient confidentiality and privacy are handled, what technical equipment is required, and what they should expect in terms of scheduling, cancellations, and billing policies. A sample consent form for telemedicine use is shown in FIGURE 1.

Liability insurance

Another hurdle that must be considered is liability insurance for conducting virtual visits with patients. Gynecologists who are going to offer telemedicine care to patients should request proof in writing that their liability insurance policy covers telemedicine malpractice and that the coverage extends to other states should the patient be in another state from the state in which the gynecologist holds a license. Additionally, gynecologists who provide telemedicine care should check with liability insurers regarding any requirements or limitations to conducting a virtual visit with their patients and should document them. For example, the policy may require that the physician keep a written or recorded record of the visit in the EHR. If that is the case, then using Skype, Facebook, or Google for the virtual visit, which do not include documentation, would be less desirable.

Privacy

Certainly, there is concern about privacy, and HIPAA compliance is critical to telemedicine success. Because of the COVID-19 emergency, as of March 1, 2020, physicians may now communicate with patients, and provide telehealth services, through remote communications without penalties.⁸ With these changes in the HIPAA requirements, physicians may use applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, and Skype, to provide telehealth without risk that the Office for Civil Rights will impose a penalty for noncompliance with HIPAA rules. The consent for patients should mention that these “public” applications potentially introduce privacy risks. This is a motivation for gynecologists to consider one of the programs that promises encryption, privacy, and HIPAA compliance, such as Updox, Doxy.me, and Amazon Chime. It is also important to recognize that a virtual visit could result in colleagues (if the patient is in an office setting) or family members (if the patient is in the home environment) overhearing conversations between the health care professional and the patient. Therefore, we suggest that patients conduct virtual visits in locations in which they feel assured of some semblance of privacy.

Continue to: Compensation for telemedicine...

Compensation for telemedicine

Perhaps the biggest barrier to virtual health adoption has been compensation for telemedicine visits. Both commercial payers and CMS have been slow to enact formal policies for telemedicine reimbursement. Because of this, the common misconceptions (that providers cannot be reimbursed for telemedicine appointments or that compensation occurs at a reduced rate) have persisted, making telemedicine economically unappealing.

The good news is that this is changing; legislation in most states is quickly embracing virtual health visits as a result of the COVID-19 pandemic.⁹ In fact, as of January 1, 2020, telemedicine services are no longer considered “optional” coverage in Medicare Advantage plans.¹⁰ Nor are they required to have an additional fee. Instead, CMS now allows telemedicine as a standard, covered benefit in all plans, enabling beneficiaries to seek care from their homes rather than requiring them to go to a health care facility.¹¹ In the past, telemedicine was restricted for use in rural areas or when patients resided a great distance from their health care providers. Starting March 6, 2020, and for the duration of the COVID-19 public health emergency, Medicare will make payment for professional services furnished to beneficiaries in all areas of the country in all settings regardless of location or distance between the patient and the health care provider.¹²

In addition, since March 15, 2020, CMS has expanded access to telemedicine services for all Medicare beneficiaries—not just those who have been diagnosed with COVID-19.¹³ The expanded access also applies to pre-COVID-19 coverage from physician offices, skilled nursing facilities, and hospitals. This means that Medicare will now make payments to physicians for telemedicine services provided in any health care facility or in a patient’s home, so that patients do not need to go to the physician’s office.

The facts are that there are parity laws and that commercial payers and CMS are required by state law to reimburse for telemedicine—often at the same rate as that for a comparable in-person visit. On the commercial side, there has been an increase in commercial parity legislation that requires health plans to cover virtual visits in the same way they cover face-to-face services. With the new guidelines for reimbursement, every state and Washington DC has parity laws in place. (To stay abreast of state-by-state changes in virtual health reimbursement, the Center for Connected Health Policy and the Advisory Board Primer are valuable resources. See “Resources.”) As long as the provider performs and documents the elements of history and decision-making, including the time spent counseling, and documents the visit as if a face-to-face visit occurred, then clinicians have a billable evaluation and management (E&M) visit.

Continue to: Virtual services for Medicare patients...

Virtual services for Medicare patients

There are 3 main types of virtual services gynecologists can provide to Medicare patients: Medicare telehealth visits, virtual check-ins, and e-visits.

Medicare telehealth visits. Largely because of the COVID-19 pandemic, Medicare patients may now use telecommunication technology for any services that previously occurred in an in-person communication. The gynecologist must use an interactive audio and video telecommunications system that permits real-time communication between the physician and the patient, and the patient should have a prior established relationship with the gynecologist with whom the telemedicine visit is taking place. The new guidelines indicate that the US Department of Health and Human Services (HHS) will not conduct audits to ensure that such a prior relationship exists for claims submitted during this public health emergency.¹⁴

The Current Procedural Terminology (CPT) codes for virtual visits using synchronous audio/visual communication are:

• 99201-99295, Office visit for a new patient
• 99211-99215, Office visit for an established patient.

Important modifiers for telemedicine visits include:

• modifier 02 for POS (place of service) for telehealth Medicare
• modifier 95 for commercial payers.

(A list of all available CPT codes for telehealth services from CMS can be found in “Resources.”)

Virtual check-ins. Established Medicare patients may have a brief communication with gynecologists the traditional way using a telephone or via live video. These brief virtual services, usually 5 to 10 minutes in duration, are initiated by the patient. The purpose of the virtual check-in is to determine if an office visit or a test or procedure is indicated.

Medicare pays for these “virtual check-ins” (or brief communication technology-based services) for patients to communicate with their physicians and avoid unnecessary trips to the office. These brief virtual check-ins are only for established patients. If an existing patient contacts the gynecologist’s office to ask a question or determine if an office visit is necessary, the gynecologist may bill for it using code G2012.

E-visits. Established Medicare patients may have non–face-to-face patient-initiated communications with their gynecologists without going to the physician’s office. These services can be billed only when the physician has an established relationship with the patient. The services may be billed using CPT codes 99421 to 99423. Coding for these visits is determined by the length of time the gynecologist spends online with the patient:

• 99421: Online digital evaluation and management service, for an established patient 5 to 10 minutes spent on the virtual visit
• 99422: 11 to 20 minutes
• 99423: ≥ 21 minutes.

Many clinicians want to immediately start the communication process with their patients. Many will avail themselves of the free video communication offered by Google Hangouts, Skype, Facetime, and Facebook Messenger. Since the March 15, 2020, relaxation of the HIPAA restrictions for telemedicine, it is now possible to have a virtual visit with a patient using one of the free, non–HIPAA-compliant connections. This type of visit is no different than a telephone call but with an added video component. Using these free technologies, a gynecologist can have an asynchronous visit with a patient (referred to as the store and forward method of sending information or medical images), which means that the service takes place in one direction with no opportunity for interaction with the patient. Asynchronous visits are akin to video text messages left for the patient. By contrast, a synchronous or real-time video visit with a patient is a 2-way communication that provides medical care without examining the patient.

Using triangulation

There are some downsides to telemedicine visits. First, virtual visits on Skype, FaceTime, and other non–HIPAA-compliant methods are not conducted on an encrypted website. Second, no documentation is created for the doctor-patient encounter. Finally, unless the physician keeps a record of these virtual visits and submits the interactions to the practice coders, there will be no billing and no reimbursement for the visits. In this scenario, physicians are legally responsible for their decision-making, prescription writing, and medical advice, but do not receive compensation for their efforts.

This can be remedied by using “triangulation,” which involves: 1. the physician, 2. the patient, and 3. a scribe or medical assistant who will record the visit. Before initiating the virtual visit using triangulation, it is imperative to ask the patient for permission if your medical assistant (or any other person in the office who functions as a scribe) will be listening to the conversation. It is important to explain that the person is there to take accurate notes and ascertain that the notes are entered into the EHR. Also, the scribe or assistant will record the time, date, and duration of the visit, which is a requirement for billing purposes. The scribe may also ascertain that the visit is properly coded and entered into the practice management system, and that a bill is submitted to the insurance company. By using triangulation, you have documentation that consent was obtained, that the visit took place, that notes were taken, and that the patient’s insurance company will be billed for the visit (see FIGURE 2 for a sample documentation form).

Continue to: Which CPT codes should I use?...

Which CPT codes should I use?

The answer depends on a number of factors, but a good rule of thumb is to use the same codes that you would use for an in-person appointment (CPT codes 99211-99215 for an established patient visit and 99201-99205 for a new patient visit). These are the most common CPT codes for outpatient gynecologic office visits whether they take place face-to-face or as a synchronous virtual visit (via a real-time interactive audio and video telecommunications system).

For example, the reimbursement for code 99213 has a range from $73 to $100. You may wonder how you can achieve the complexity requirements for a level-3 office visit without a physical examination. Whether as a face-to-face or virtual visit, documentation for these encounters requires 2 of 3 of the following components:

• expanded problem-focused history
• expanded problem-focused exam (not accomplished with telemedicine)
• low-complexity medical decision-making OR
• at least 15 minutes spent face to face with the patient if coding is based on time.

If a gynecologist reviews the results of a recent lab test for an estrogen-deficient patient and adjusts the estrogen dosage, writes a prescription, and spends 15 minutes communicating with the patient, he/she has met the complexity requirements for a code 99213. Because Level 3 and 4 visits (99214 and 99215) require a comprehensive physical examination, it is necessary to document the time spent with the patient (code 99214 requires 25 to 39 minutes of consultation and code 99215 requires ≥ 40 minutes).

Some final billing and coding advice

Always confirm telemedicine billing guidelines before beginning to conduct telemedicine visits. Consider starting a phone call to a payer armed with the fact that the payer is required by law to offer parity between telemedicine and face-to-face visits. Then ask which specific billing codes should be used.

Until you and your practice become comfortable with the process of, and the coding and billing for, telemedicine, consider using a telemedicine platform that has a built-in rules engine that offers recommendations for each telemedicine visit based on past claims data. These systems help gynecologists determine which CPT code to use and which modifiers are appropriate for the various insurance companies. In other words, the rules engine helps you submit a clean claim that is less likely to be denied and very likely to be paid. There are some vendors who are so confident that their rules engine will match the service with the proper CPT code and modifier that they guarantee full private payer reimbursement for telemedicine visits, or the vendor will reimburse the claim.

Watch for the third and final installment in this series, which was written with the assistance of 2 attorneys. It will review the legal guidelines for implementing telemedicine in a gynecologic practice and discuss the future of the technology. ●

Stadnytskyi and colleagues explored the size of droplets created by speech using a highly sensitive laser system. They reported in PNAS that speaking resulted in the generation of a high number of medium-sized droplets (10- to 100-µm in diameter). Under the conditions of their experiment (27% humidity and 23° C) they reported that speech probably generates droplets that originate at a size of 12 to 21 µm in diameter and quickly dehydrate to an estimated diameter of 4 µm. The 4 µm-sized particles had a falling rate of only 0.06 cm·s⁻¹ and remained airborne for 8 to 14 minutes.¹

As reported by Hamner and colleagues, on March 10, 2020, 61 persons attended a 2.5-hour choir practice. One choir member had symptoms of an upper respiratory infection that began on March 7. Eventually that choir member tested positive for SARS-CoV-2. Of the 60 remaining persons, 52 (86.7%) eventually developed an upper respiratory illness. In total, 33 cases of SARS-CoV-2 were confirmed by nucleic acid testing and 20 probable cases were diagnosed (these individuals declined testing). The  choir attendees developed symptoms at a median of 3 days following the practice, with a range of 1 to 12 days. Three of the 53 ill people were hospitalized, and two died.²

The Stadnytskyi study suggests that speech generates large respiratory droplets that dehydrate into very small droplets that may remain in the air for an extended period of time. If the SARS-CoV-2 virus were in the original large droplet, the rapid dehydration of the droplet would result in prolonged airborne presence of the virus and enhance its infectivity.

The Hamner study highlights the importance of vocalization and respiratory particles in transmitting the SARS-CoV-2 virus. For clinicians and patients, both studies support many recommendations to reduce viral transmission, including:

• all clinicians and patients need to wear face masks
• all clinicians and patients should avoid face-to-face contact if alternative approaches to communication are possible
• all clinicians and patients should avoid gathering in large groups or crowded public spaces and need to maintain physical distancing.

The COVID pandemic has dramatically changed how we practice medicine and socialize.

Stadnytskyi and colleagues explored the size of droplets created by speech using a highly sensitive laser system. They reported in PNAS that speaking resulted in the generation of a high number of medium-sized droplets (10- to 100-µm in diameter). Under the conditions of their experiment (27% humidity and 23° C) they reported that speech probably generates droplets that originate at a size of 12 to 21 µm in diameter and quickly dehydrate to an estimated diameter of 4 µm. The 4 µm-sized particles had a falling rate of only 0.06 cm·s⁻¹ and remained airborne for 8 to 14 minutes.¹

As reported by Hamner and colleagues, on March 10, 2020, 61 persons attended a 2.5-hour choir practice. One choir member had symptoms of an upper respiratory infection that began on March 7. Eventually that choir member tested positive for SARS-CoV-2. Of the 60 remaining persons, 52 (86.7%) eventually developed an upper respiratory illness. In total, 33 cases of SARS-CoV-2 were confirmed by nucleic acid testing and 20 probable cases were diagnosed (these individuals declined testing). The  choir attendees developed symptoms at a median of 3 days following the practice, with a range of 1 to 12 days. Three of the 53 ill people were hospitalized, and two died.²

The Stadnytskyi study suggests that speech generates large respiratory droplets that dehydrate into very small droplets that may remain in the air for an extended period of time. If the SARS-CoV-2 virus were in the original large droplet, the rapid dehydration of the droplet would result in prolonged airborne presence of the virus and enhance its infectivity.

The Hamner study highlights the importance of vocalization and respiratory particles in transmitting the SARS-CoV-2 virus. For clinicians and patients, both studies support many recommendations to reduce viral transmission, including:

• all clinicians and patients need to wear face masks
• all clinicians and patients should avoid face-to-face contact if alternative approaches to communication are possible
• all clinicians and patients should avoid gathering in large groups or crowded public spaces and need to maintain physical distancing.

The COVID pandemic has dramatically changed how we practice medicine and socialize.

Stadnytskyi and colleagues explored the size of droplets created by speech using a highly sensitive laser system. They reported in PNAS that speaking resulted in the generation of a high number of medium-sized droplets (10- to 100-µm in diameter). Under the conditions of their experiment (27% humidity and 23° C) they reported that speech probably generates droplets that originate at a size of 12 to 21 µm in diameter and quickly dehydrate to an estimated diameter of 4 µm. The 4 µm-sized particles had a falling rate of only 0.06 cm·s⁻¹ and remained airborne for 8 to 14 minutes.¹

As reported by Hamner and colleagues, on March 10, 2020, 61 persons attended a 2.5-hour choir practice. One choir member had symptoms of an upper respiratory infection that began on March 7. Eventually that choir member tested positive for SARS-CoV-2. Of the 60 remaining persons, 52 (86.7%) eventually developed an upper respiratory illness. In total, 33 cases of SARS-CoV-2 were confirmed by nucleic acid testing and 20 probable cases were diagnosed (these individuals declined testing). The  choir attendees developed symptoms at a median of 3 days following the practice, with a range of 1 to 12 days. Three of the 53 ill people were hospitalized, and two died.²

The Stadnytskyi study suggests that speech generates large respiratory droplets that dehydrate into very small droplets that may remain in the air for an extended period of time. If the SARS-CoV-2 virus were in the original large droplet, the rapid dehydration of the droplet would result in prolonged airborne presence of the virus and enhance its infectivity.

The Hamner study highlights the importance of vocalization and respiratory particles in transmitting the SARS-CoV-2 virus. For clinicians and patients, both studies support many recommendations to reduce viral transmission, including:

• all clinicians and patients need to wear face masks
• all clinicians and patients should avoid face-to-face contact if alternative approaches to communication are possible
• all clinicians and patients should avoid gathering in large groups or crowded public spaces and need to maintain physical distancing.

The COVID pandemic has dramatically changed how we practice medicine and socialize.

The Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the VentFree Respiratory Muscle Stimulator in order to potentially reduce the number of days adult patients, including those with COVID-19, require mechanical ventilation, according to a press release from Liberate Medical.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

In comparison with mechanical ventilation, which is invasive and commonly weakens the breathing muscles, the VentFree system uses noninvasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation, according to the press release. This allows patients to begin treatment during the early stages of ventilation while they are sedated and to continue until they are weaned off of ventilation.

A pair of pilot randomized, controlled studies, completed in Europe and Australia, showed that VentFree helped to reduce ventilation duration and ICU length of stay, compared with placebo stimulation. The FDA granted VentFree Breakthrough Device status in 2019.

“We are grateful to the FDA for recognizing the potential of VentFree and feel privileged to have the opportunity to help patients on mechanical ventilation during the COVID-19 pandemic,” Angus McLachlan PhD, cofounder and CEO of Liberate Medical, said in the press release.

VentFree has been authorized for use only for the duration of the current COVID-19 emergency, as it has not yet been approved or cleared for usage by primary care providers.

lfranki@mdedge.com

The Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the VentFree Respiratory Muscle Stimulator in order to potentially reduce the number of days adult patients, including those with COVID-19, require mechanical ventilation, according to a press release from Liberate Medical.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

In comparison with mechanical ventilation, which is invasive and commonly weakens the breathing muscles, the VentFree system uses noninvasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation, according to the press release. This allows patients to begin treatment during the early stages of ventilation while they are sedated and to continue until they are weaned off of ventilation.

A pair of pilot randomized, controlled studies, completed in Europe and Australia, showed that VentFree helped to reduce ventilation duration and ICU length of stay, compared with placebo stimulation. The FDA granted VentFree Breakthrough Device status in 2019.

“We are grateful to the FDA for recognizing the potential of VentFree and feel privileged to have the opportunity to help patients on mechanical ventilation during the COVID-19 pandemic,” Angus McLachlan PhD, cofounder and CEO of Liberate Medical, said in the press release.

VentFree has been authorized for use only for the duration of the current COVID-19 emergency, as it has not yet been approved or cleared for usage by primary care providers.

lfranki@mdedge.com

The Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the VentFree Respiratory Muscle Stimulator in order to potentially reduce the number of days adult patients, including those with COVID-19, require mechanical ventilation, according to a press release from Liberate Medical.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

In comparison with mechanical ventilation, which is invasive and commonly weakens the breathing muscles, the VentFree system uses noninvasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation, according to the press release. This allows patients to begin treatment during the early stages of ventilation while they are sedated and to continue until they are weaned off of ventilation.

A pair of pilot randomized, controlled studies, completed in Europe and Australia, showed that VentFree helped to reduce ventilation duration and ICU length of stay, compared with placebo stimulation. The FDA granted VentFree Breakthrough Device status in 2019.

“We are grateful to the FDA for recognizing the potential of VentFree and feel privileged to have the opportunity to help patients on mechanical ventilation during the COVID-19 pandemic,” Angus McLachlan PhD, cofounder and CEO of Liberate Medical, said in the press release.

VentFree has been authorized for use only for the duration of the current COVID-19 emergency, as it has not yet been approved or cleared for usage by primary care providers.

lfranki@mdedge.com

Due to the impact of the coronavirus disease 2019 (COVID-19) pandemic, many patients are working from home, which has led to a unique opportunity for dermatologists to step in and continue to care for their patients at home via telemedicine. With recent waivers and guidance from the Centers for Medicare & Medicaid Services (CMS), insurance coverage has been expanded for telehealth services, usually at the same level as an in-person visit. This editorial provides guidance for implementing telehealth services in your practice, and a tip sheet is available online for you to save and print. Please note that this information is changing on a day-to-day basis, so refer to the resources in the Table to get the latest updates.

Billing and Coding

The best reimbursements are for live telemedicine that emulates an outpatient visit and is billed using the same Current Procedural Terminology (CPT) codes (99201–99215). Previously, Medicare did not allow direct-to-patient visits to be billed, instead requiring a waiver for these services to be provided in underserved areas. During the COVID-19 pandemic, this requirement has been lifted, allowing all patients to be seen from any originating site (eg, the patient’s home).

Previously, the CMS had issued guidelines for telehealth visits that required that a physician-patient relationship be established in person prior to conducting telemedicine visits. These guidelines also have been waived for the duration of this public health emergency, allowing physicians to conduct new patient visits via telehealth and bill Medicare. Many commercial payors also are covering new patient visits via telehealth; however, it is best to check the patient’s plan first, as some plans may have different requirements or restrictions on allowable CPT codes and/or place of service. Prior requirements that physicians at a distant site (ie, the physician providing telemedicine services) be located at a site of clinical care also have been relaxed, thus allowing physicians to be located anywhere while providing services, even for those who are confined to their homes.

In general, commercial payors are covering telehealth visits at 100% of an in-person visit. Although COVID-19–related visits are covered by law, many payors including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Emblem Health, Humana, and United Healthcare have indicated that they will waive all telehealth co-pays for a limited time, including visits not related to COVID-19. At the time of publication, only Aetna has issued a formal policy to this effect, so it is best to check with the insurer.^1,2 However, it is important to note that regional and employer-specific plans may have different policies, so it is best to check with the insurance plans directly to confirm coverage and co-pay status.

Coding should be performed using the usual new/established patient visit codes for outpatients (99201–99215). A place of service (POS) code of 02 previously was used for all telehealth visits; however, the CMS is allowing offices to bill with their usual POS (generally POS 11) and modifier -95 in an updated rule that is active during this public health crisis. This change allows access to higher reimbursements, as POS 02 visits are paid at lower facility fee rates. Commercial insurers have varying policies on POS that are changing, so it is best to check with them individually.

In certain states, store-and-forward services may be billed using a GQ modifier for Medicaid; however, the remote check-in and telephone codes for Medicare do not reimburse well and generally are best avoided if a live telemedicine encounter is possible, as it provides better patient care and direct counseling capabilities, similar to an in-person visit. The CMS has indicated that it is now covering telephone visits (99441-99443) so that providers can contact patients through an audio-only device and bill for the encounter. Generally speaking, telephone visits reimburse the same or more than the virtual check-in codes (G2010/G2012) as long as the telephone encounter is more than 5-minutes long. Digital visits also are available (99421-99423), which include both store-and-forward photographs and a telephone call, but the reimbursements are similar to the telephone-only visit codes.³

Although the CMS has relaxed regulations for physicians to provide care across state lines, not all state licensing authorities have adopted similar measures, and the CMS waiver only applies to federally funded programs. It is important to check with state medical licensing authorities to see whether you are authorized to provide care if your patient is not located within the state where you hold your license at the time of the visit. Many states, but not all, have waived this requirement or have set up very expedient ways to apply for telemedicine licenses.

The CMS also released guidance that rules for documentation requirements have been temporarily relaxed,³ such that visits should be billed at a level of service consistent with either medical decision-making or total time spent by the provider, including face-to-face and non–face-to-face time spent on the patient. (Note: If billing by time, which usually is not advised, use the CMS definitions of time-based coding.) History and physical examination criteria do not have to be met.

Workflow

In general, it is best to maintain your current workflow as much as possible, with a live video encounter replacing only the patient interaction portion of the visit. You will need to maintain an infrastructure for scheduling visits, collecting co-pays (eg, over the telephone prior to the video visit), and documentation/billing.

It is best to have one device for conducting the actual video visit (eg, a laptop, tablet, or smartphone) and a separate device to use for documentation (eg, another device to access the electronic medical record). The CMS has advised that it will not enforce Health Insurance Portability and Accountability Act (HIPAA) rules,⁴ allowing physicians to use video conferencing and chat applications such as FaceTime, Skype, or Google Hangouts; however, patient safety is still an issue, and it is imperative to make sure you identify the patient correctly upon starting the visit. During the COVID-19 pandemic, numerous telehealth companies are offering temporary free video conferencing software that is HIPAA compliant, such as Doximity, VSee, Doxy.me, and Medweb. If you are able to go through one of these vendors, you will be able to continue conducting some telemedicine visits after the public health emergency, which may be helpful to your practice.

For some visits, such as acne patients on isotretinoin, you can write for a standing laboratory order that can be drawn at a laboratory center near your patient, and you can perform the counseling via telemedicine. For patients on isotretinoin, iPledge has issued a program update allowing the use of at-home pregnancy tests during the pandemic. The results must be communicated to the provider and documented with a time/date.⁵

Video Visit Tips and Pearls

Make sure to have well-defined parameters about what can be triaged via a single video visit. Suggestions include no total-body skin examinations and a limit of 1 rash or 2 lesions. Provide a disclaimer that it is not always possible to tell whether or not a lesion is concerning via a video visit, and the patient may have to come in for a biopsy at some point.

It is better to overcall via telemedicine than to undercall. Unless something is a very obvious seborrheic keratosis, skin tag, cherry angioma, or other benign lesion, it might be reasonable to tell a patient to come in for further evaluation of a worrisome lesion after things get back to normal. A static photograph from the patient can be helpful so it is clear what lesion is being examined during the current visit. If the patient has a skin cancer at a distant site in the future, there will be no doubt as to what lesion you examined. Having the capability to receive static images from the patient to serve as representative photographs of their chief concern is very helpful before the visit. Often, these images turn out to be better diagnostically than the live video itself, which can be compressed and show inaccurate colors. Some of the telemedicine vendors have this feature built-in, which is preferable. If you are asking patients to send you emails, it is better to have access to a HIPAA-compliant email inbox to avoid any potential issues down the line.

When scheduling a video visit, have your schedulers specifically tell patients that they should be on a high-speed Wi-Fi connection with good lighting in the room. You would be surprised that this is not intuitive for everyone!

Finally, most telemedicine visits are relatively short and to the point. In the beginning, start by scheduling patients every 15 to 20 minutes to allow for technical difficulties, but ultimately plan to be seeing patients at least every 10 minutes—it can be quite efficient!

Due to the impact of the coronavirus disease 2019 (COVID-19) pandemic, many patients are working from home, which has led to a unique opportunity for dermatologists to step in and continue to care for their patients at home via telemedicine. With recent waivers and guidance from the Centers for Medicare & Medicaid Services (CMS), insurance coverage has been expanded for telehealth services, usually at the same level as an in-person visit. This editorial provides guidance for implementing telehealth services in your practice, and a tip sheet is available online for you to save and print. Please note that this information is changing on a day-to-day basis, so refer to the resources in the Table to get the latest updates.

Billing and Coding

The best reimbursements are for live telemedicine that emulates an outpatient visit and is billed using the same Current Procedural Terminology (CPT) codes (99201–99215). Previously, Medicare did not allow direct-to-patient visits to be billed, instead requiring a waiver for these services to be provided in underserved areas. During the COVID-19 pandemic, this requirement has been lifted, allowing all patients to be seen from any originating site (eg, the patient’s home).

Previously, the CMS had issued guidelines for telehealth visits that required that a physician-patient relationship be established in person prior to conducting telemedicine visits. These guidelines also have been waived for the duration of this public health emergency, allowing physicians to conduct new patient visits via telehealth and bill Medicare. Many commercial payors also are covering new patient visits via telehealth; however, it is best to check the patient’s plan first, as some plans may have different requirements or restrictions on allowable CPT codes and/or place of service. Prior requirements that physicians at a distant site (ie, the physician providing telemedicine services) be located at a site of clinical care also have been relaxed, thus allowing physicians to be located anywhere while providing services, even for those who are confined to their homes.

In general, commercial payors are covering telehealth visits at 100% of an in-person visit. Although COVID-19–related visits are covered by law, many payors including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Emblem Health, Humana, and United Healthcare have indicated that they will waive all telehealth co-pays for a limited time, including visits not related to COVID-19. At the time of publication, only Aetna has issued a formal policy to this effect, so it is best to check with the insurer.^1,2 However, it is important to note that regional and employer-specific plans may have different policies, so it is best to check with the insurance plans directly to confirm coverage and co-pay status.

Coding should be performed using the usual new/established patient visit codes for outpatients (99201–99215). A place of service (POS) code of 02 previously was used for all telehealth visits; however, the CMS is allowing offices to bill with their usual POS (generally POS 11) and modifier -95 in an updated rule that is active during this public health crisis. This change allows access to higher reimbursements, as POS 02 visits are paid at lower facility fee rates. Commercial insurers have varying policies on POS that are changing, so it is best to check with them individually.

In certain states, store-and-forward services may be billed using a GQ modifier for Medicaid; however, the remote check-in and telephone codes for Medicare do not reimburse well and generally are best avoided if a live telemedicine encounter is possible, as it provides better patient care and direct counseling capabilities, similar to an in-person visit. The CMS has indicated that it is now covering telephone visits (99441-99443) so that providers can contact patients through an audio-only device and bill for the encounter. Generally speaking, telephone visits reimburse the same or more than the virtual check-in codes (G2010/G2012) as long as the telephone encounter is more than 5-minutes long. Digital visits also are available (99421-99423), which include both store-and-forward photographs and a telephone call, but the reimbursements are similar to the telephone-only visit codes.³

Although the CMS has relaxed regulations for physicians to provide care across state lines, not all state licensing authorities have adopted similar measures, and the CMS waiver only applies to federally funded programs. It is important to check with state medical licensing authorities to see whether you are authorized to provide care if your patient is not located within the state where you hold your license at the time of the visit. Many states, but not all, have waived this requirement or have set up very expedient ways to apply for telemedicine licenses.

The CMS also released guidance that rules for documentation requirements have been temporarily relaxed,³ such that visits should be billed at a level of service consistent with either medical decision-making or total time spent by the provider, including face-to-face and non–face-to-face time spent on the patient. (Note: If billing by time, which usually is not advised, use the CMS definitions of time-based coding.) History and physical examination criteria do not have to be met.

Workflow

In general, it is best to maintain your current workflow as much as possible, with a live video encounter replacing only the patient interaction portion of the visit. You will need to maintain an infrastructure for scheduling visits, collecting co-pays (eg, over the telephone prior to the video visit), and documentation/billing.

It is best to have one device for conducting the actual video visit (eg, a laptop, tablet, or smartphone) and a separate device to use for documentation (eg, another device to access the electronic medical record). The CMS has advised that it will not enforce Health Insurance Portability and Accountability Act (HIPAA) rules,⁴ allowing physicians to use video conferencing and chat applications such as FaceTime, Skype, or Google Hangouts; however, patient safety is still an issue, and it is imperative to make sure you identify the patient correctly upon starting the visit. During the COVID-19 pandemic, numerous telehealth companies are offering temporary free video conferencing software that is HIPAA compliant, such as Doximity, VSee, Doxy.me, and Medweb. If you are able to go through one of these vendors, you will be able to continue conducting some telemedicine visits after the public health emergency, which may be helpful to your practice.

For some visits, such as acne patients on isotretinoin, you can write for a standing laboratory order that can be drawn at a laboratory center near your patient, and you can perform the counseling via telemedicine. For patients on isotretinoin, iPledge has issued a program update allowing the use of at-home pregnancy tests during the pandemic. The results must be communicated to the provider and documented with a time/date.⁵

Video Visit Tips and Pearls

Make sure to have well-defined parameters about what can be triaged via a single video visit. Suggestions include no total-body skin examinations and a limit of 1 rash or 2 lesions. Provide a disclaimer that it is not always possible to tell whether or not a lesion is concerning via a video visit, and the patient may have to come in for a biopsy at some point.

It is better to overcall via telemedicine than to undercall. Unless something is a very obvious seborrheic keratosis, skin tag, cherry angioma, or other benign lesion, it might be reasonable to tell a patient to come in for further evaluation of a worrisome lesion after things get back to normal. A static photograph from the patient can be helpful so it is clear what lesion is being examined during the current visit. If the patient has a skin cancer at a distant site in the future, there will be no doubt as to what lesion you examined. Having the capability to receive static images from the patient to serve as representative photographs of their chief concern is very helpful before the visit. Often, these images turn out to be better diagnostically than the live video itself, which can be compressed and show inaccurate colors. Some of the telemedicine vendors have this feature built-in, which is preferable. If you are asking patients to send you emails, it is better to have access to a HIPAA-compliant email inbox to avoid any potential issues down the line.

When scheduling a video visit, have your schedulers specifically tell patients that they should be on a high-speed Wi-Fi connection with good lighting in the room. You would be surprised that this is not intuitive for everyone!

Finally, most telemedicine visits are relatively short and to the point. In the beginning, start by scheduling patients every 15 to 20 minutes to allow for technical difficulties, but ultimately plan to be seeing patients at least every 10 minutes—it can be quite efficient!

Due to the impact of the coronavirus disease 2019 (COVID-19) pandemic, many patients are working from home, which has led to a unique opportunity for dermatologists to step in and continue to care for their patients at home via telemedicine. With recent waivers and guidance from the Centers for Medicare & Medicaid Services (CMS), insurance coverage has been expanded for telehealth services, usually at the same level as an in-person visit. This editorial provides guidance for implementing telehealth services in your practice, and a tip sheet is available online for you to save and print. Please note that this information is changing on a day-to-day basis, so refer to the resources in the Table to get the latest updates.

Billing and Coding

The best reimbursements are for live telemedicine that emulates an outpatient visit and is billed using the same Current Procedural Terminology (CPT) codes (99201–99215). Previously, Medicare did not allow direct-to-patient visits to be billed, instead requiring a waiver for these services to be provided in underserved areas. During the COVID-19 pandemic, this requirement has been lifted, allowing all patients to be seen from any originating site (eg, the patient’s home).

Previously, the CMS had issued guidelines for telehealth visits that required that a physician-patient relationship be established in person prior to conducting telemedicine visits. These guidelines also have been waived for the duration of this public health emergency, allowing physicians to conduct new patient visits via telehealth and bill Medicare. Many commercial payors also are covering new patient visits via telehealth; however, it is best to check the patient’s plan first, as some plans may have different requirements or restrictions on allowable CPT codes and/or place of service. Prior requirements that physicians at a distant site (ie, the physician providing telemedicine services) be located at a site of clinical care also have been relaxed, thus allowing physicians to be located anywhere while providing services, even for those who are confined to their homes.

In general, commercial payors are covering telehealth visits at 100% of an in-person visit. Although COVID-19–related visits are covered by law, many payors including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Emblem Health, Humana, and United Healthcare have indicated that they will waive all telehealth co-pays for a limited time, including visits not related to COVID-19. At the time of publication, only Aetna has issued a formal policy to this effect, so it is best to check with the insurer.^1,2 However, it is important to note that regional and employer-specific plans may have different policies, so it is best to check with the insurance plans directly to confirm coverage and co-pay status.

Coding should be performed using the usual new/established patient visit codes for outpatients (99201–99215). A place of service (POS) code of 02 previously was used for all telehealth visits; however, the CMS is allowing offices to bill with their usual POS (generally POS 11) and modifier -95 in an updated rule that is active during this public health crisis. This change allows access to higher reimbursements, as POS 02 visits are paid at lower facility fee rates. Commercial insurers have varying policies on POS that are changing, so it is best to check with them individually.

In certain states, store-and-forward services may be billed using a GQ modifier for Medicaid; however, the remote check-in and telephone codes for Medicare do not reimburse well and generally are best avoided if a live telemedicine encounter is possible, as it provides better patient care and direct counseling capabilities, similar to an in-person visit. The CMS has indicated that it is now covering telephone visits (99441-99443) so that providers can contact patients through an audio-only device and bill for the encounter. Generally speaking, telephone visits reimburse the same or more than the virtual check-in codes (G2010/G2012) as long as the telephone encounter is more than 5-minutes long. Digital visits also are available (99421-99423), which include both store-and-forward photographs and a telephone call, but the reimbursements are similar to the telephone-only visit codes.³

Although the CMS has relaxed regulations for physicians to provide care across state lines, not all state licensing authorities have adopted similar measures, and the CMS waiver only applies to federally funded programs. It is important to check with state medical licensing authorities to see whether you are authorized to provide care if your patient is not located within the state where you hold your license at the time of the visit. Many states, but not all, have waived this requirement or have set up very expedient ways to apply for telemedicine licenses.

The CMS also released guidance that rules for documentation requirements have been temporarily relaxed,³ such that visits should be billed at a level of service consistent with either medical decision-making or total time spent by the provider, including face-to-face and non–face-to-face time spent on the patient. (Note: If billing by time, which usually is not advised, use the CMS definitions of time-based coding.) History and physical examination criteria do not have to be met.

Workflow

In general, it is best to maintain your current workflow as much as possible, with a live video encounter replacing only the patient interaction portion of the visit. You will need to maintain an infrastructure for scheduling visits, collecting co-pays (eg, over the telephone prior to the video visit), and documentation/billing.

It is best to have one device for conducting the actual video visit (eg, a laptop, tablet, or smartphone) and a separate device to use for documentation (eg, another device to access the electronic medical record). The CMS has advised that it will not enforce Health Insurance Portability and Accountability Act (HIPAA) rules,⁴ allowing physicians to use video conferencing and chat applications such as FaceTime, Skype, or Google Hangouts; however, patient safety is still an issue, and it is imperative to make sure you identify the patient correctly upon starting the visit. During the COVID-19 pandemic, numerous telehealth companies are offering temporary free video conferencing software that is HIPAA compliant, such as Doximity, VSee, Doxy.me, and Medweb. If you are able to go through one of these vendors, you will be able to continue conducting some telemedicine visits after the public health emergency, which may be helpful to your practice.

For some visits, such as acne patients on isotretinoin, you can write for a standing laboratory order that can be drawn at a laboratory center near your patient, and you can perform the counseling via telemedicine. For patients on isotretinoin, iPledge has issued a program update allowing the use of at-home pregnancy tests during the pandemic. The results must be communicated to the provider and documented with a time/date.⁵

Video Visit Tips and Pearls

Make sure to have well-defined parameters about what can be triaged via a single video visit. Suggestions include no total-body skin examinations and a limit of 1 rash or 2 lesions. Provide a disclaimer that it is not always possible to tell whether or not a lesion is concerning via a video visit, and the patient may have to come in for a biopsy at some point.

It is better to overcall via telemedicine than to undercall. Unless something is a very obvious seborrheic keratosis, skin tag, cherry angioma, or other benign lesion, it might be reasonable to tell a patient to come in for further evaluation of a worrisome lesion after things get back to normal. A static photograph from the patient can be helpful so it is clear what lesion is being examined during the current visit. If the patient has a skin cancer at a distant site in the future, there will be no doubt as to what lesion you examined. Having the capability to receive static images from the patient to serve as representative photographs of their chief concern is very helpful before the visit. Often, these images turn out to be better diagnostically than the live video itself, which can be compressed and show inaccurate colors. Some of the telemedicine vendors have this feature built-in, which is preferable. If you are asking patients to send you emails, it is better to have access to a HIPAA-compliant email inbox to avoid any potential issues down the line.

When scheduling a video visit, have your schedulers specifically tell patients that they should be on a high-speed Wi-Fi connection with good lighting in the room. You would be surprised that this is not intuitive for everyone!

Finally, most telemedicine visits are relatively short and to the point. In the beginning, start by scheduling patients every 15 to 20 minutes to allow for technical difficulties, but ultimately plan to be seeing patients at least every 10 minutes—it can be quite efficient!

The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.

When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.

“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.

The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.

In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.

“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”

At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.

In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.

To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.

Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.

“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”

agallegos@mdedge.com

The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.

When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.

“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.

The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.

In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.

“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”

At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.

In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.

To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.

Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.

“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”

agallegos@mdedge.com

The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.

When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.

“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.

The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.

In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.

“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”

At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.

In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.

To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.

Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.

“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”

agallegos@mdedge.com

In 2016, the Cancer Care Coordinator at the US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACT) in West Haven partnered with the VA New England Healthcare System to use its telementoring program. The VA Specialty Care Access Network Extension for Community Healthcare Outcomes (VA ECHO) was used to present a series of educational conferences on cancer care. This article describes our experience implementing the program and reviews participant feedback gathered from voluntary surveys.

Background

In 2011, the Veterans Health Administration (VHA) Office of Healthcare Transformation launched VA ECHO, a telementoring program for primary care providers (PCPs) and patient-aligned care team staff. VACT was selected as 1 of 7 hub sites across the US. The VA ECHO system uses video and online technology to provide PCPs with case-based specialist consultation and didactic education. The system enables providers at any VA location to participate in online and telephone conferences in real time. The presentations are recorded and made available online to VA providers through a secure site.

VA ECHO is based on the highly successful Project ECHO model established by Sanjeev Arora and the University of New Mexico in 2007.¹ The rationale for Project ECHO was that patient care could be improved by increasing the competence of PCPs in the management of complex diseases by providing access to disease specialists through a case-based learning approach that used technology, which it termed knowledge networks, to connect the PCPs to specialists.

The original model addressed management of hepatitis C in a medically underserved area where half of the population was widely geographically dispersed, making the provision of specialty care challenging. Developers identified 6 characteristics that make a disease appropriate for treatment using the Project ECHO knowledge network model:

• The disease is common;
• Management of the disease is complex;
• Treatment for the disease is evolving;
• The disease has a high societal impact;
• There are serious outcomes if the disease is not treated; and
• Disease management improves outcomes.¹

VA ECHO conferences are available to all VA personnel. Staff can subscribe to an e-mail group list to be alerted to conference times and topics. Participants can connect directly to the conference using Microsoft Outlook Lync or Skype (Redmond, WA) and see the slides in real time on their computer as they listen to the presentation. The presentations are recorded, and the slides with audio can be accessed easily on the VA ECHO SharePoint site for download, enabling VA staff to listen to conferences at their convenience (Figure).

VA Cancer ECHO

The impetus to create a series of talks related to cancer care using VA ECHO was the frequent and often time-consuming requests we received from colleagues at other VA sites for information about areas of cancer care, such as survivorship and cancer care coordination. It was felt that presenting cancer care information as a VA ECHO series would make this information available to a large group of providers at one time, making the method more time effective than sharing the information via one-on-one conversations.

The cancer care coordinator originally conceived this as a 3-part, 1-time series to present work done at VACT in the areas of survivorship, psychosocial distress monitoring, and coordination of cancer care using the VA Cancer Care Tracking System, an online tracking tool. Information about the series was disseminated via VA group e-mail lists for oncology providers and via the existing VA ECHO subscriber invitation process. The 3-presentation series garnered positive feedback and had attendance that ranged from 49 to 75 participants (mean, 60). Participants expressed enthusiasm for the format via e-mail and phone feedback directly to the West Haven staff.

Expansion

The success of this original 3-part series led to a trial of an ongoing Cancer Care Conference series (Conference) using VA ECHO. This was a novel use of VA ECHO and was outside its traditional format, which is geared to discussion of individual cases and clinical knowledge. Nevertheless, this new style of communication has been embraced by a wide range of VA cancer care professionals.

One reason we considered expanding the program was that oncology fit the framework of the original Project ECHO knowledge network model. Cancer is common at the VA, which cares for 175,000 patients with cancer annually.² The management of cancer is complex involving many disciplines working together, and treatments are constantly changing. In addition, cancer has a high societal impact; there are serious outcomes both in terms of patient survival and patient symptom burden. And lastly, outcomes are improved with proactive disease management that is informed by the most current, evidence-based medicine.

The Conference was conceived as a forum for providers across disciplines to share best practices and discuss common challenges in caring for veterans with cancer. We invited participants to submit proposals for presentations related to cancer care initiatives at their VA sites. Potential speakers across all areas of care for veterans with cancer were invited to submit possible topics for the conference. The submissions were reviewed by the moderators in an effort to create a series of talks on a variety of topics across all aspects of care for oncology patients in the VA. This process of effectively crowd-sourcing educational content inspires providers to think more creatively about their practice and quality improvement projects and has sparked an ongoing dialogue about quality initiatives among VA oncology providers across disciplines and geographic locations. As a result, this approach also has enabled participants to learn from colleagues who work at a wide range of rural and urban VA locations throughout the country and to network with colleagues who are working on similar quality initiatives and challenges related to caring for veterans with cancer.

Program

The first Conference talk was in October 2016. It encompassed ten 1-hour talks during the 2016 to 2017 academic year. Speakers were recruited from the VACT West Haven campus and from several other VA sites nationwide. Topics included survivorship, psychosocial distress, palliative care, cancer navigation, and establishing a clinical trials program.

In its first year, the Conference series had 260 unique attendees representing such disciplines as medicine, nursing, social work, pharmacy, psychology, and clinic administration and representing all 21 Veterans Integrated Services Networks (VISNs). Speakers including oncologists, hepatologists, cancer care coordinators, health psychologists, and a research coordinator gave presentations on psychosocial distress screening and issues, cognitive behavioral therapy for cancer pain, cancer navigation, cancer case tracking, VISN-based liver cancer tumor tracker and liver tumor board, starting a VA-based clinical trial, palliative care, and survivorship.

The Conference accounted for 508 continuing medical education (CME) hours, which accounted for one-third of the total CME hours generated by the VACT West Haven VA ECHO program. Highlights of the talks were presented at the 2017 Association of VA Hematology/Oncology annual meeting in Denver, Colorado.

During the second year of the Conference, speakers were recruited to address new American College of Surgeons Commission on Cancer (CoC) requirements regarding survivorship treatment summaries for a subset of cancer survivors.³ The focus on survivorship was driven by ongoing feedback from participants who were working on initiatives to implement this process at their VA sites and wanted to learn from peers involved in this process throughout the VA system. Several speakers gave talks on implementing survivorship care at their VA and specifically on the use of computerized patient record system templates to create survivorship treatment summaries for veterans in accordance with CoC standards.

Since the first Conference in 2016, the number of unique attendees grew by 20% to 327 in 2018. During its first 2 years, participants have earned a total of 1,095 CME credits through Yale University CME. Conferences are usually broadcast at noon eastern time so that providers can take advantage of sessions during lunch breaks.

Participant Surveys

Attendees were invited to participate in voluntary, anonymous surveys to obtain feedback on and to receive input on topics of interest for future talks. Participants also were asked to comment on resources that they utilized to be updated on practice changes (Table 1). 

The Conference has led to increased awareness of other continuing education opportunities available through VA ECHO-Connecticut. Of survey participants, 20% reported that they had attended other VA ECHO conferences.

The survey samples are self-selecting and may not necessarily be representative of the Conference participants or of the VA oncology interdisciplinary team as a whole; however, the relatively large number of survey participants provides some confidence that these survey results can help inform future planning for this and other continuing education opportunities for VA oncology providers.

An additional online survey was designed to elucidate whether participants were incorporating knowledge gained from the Conference in their cancer care practice. Half of the 32 participants strongly agreed with the following statement: “Participation in the VA Cancer Care Conference has added to my knowledge of information relevant to my practice,” and 13 more agreed with the statement for a total of 90.6% of those surveyed responding affirmatively. Only 3 participants neither agreed nor disagreed, and none disagreed with the statement. More than half of the participants reported that they made changes to their practice or plan to make changes as a result of the Conference.

Conculsion

The VA ECHO program established at the VACT West Haven campus in 2012 now offers regular monthly or bimonthly conferences in 9 specialties: pain, liver/hepatitis C, neurology, nephrology, cardiology, diabetes/endocrinology, mental health and addiction, nursing grand rounds, and cancer care. The VACT ECHO program is led by a medical director, and each specialty has a clinical director who conducts sessions and recruits other specialists from their department.

Teleconferencing can provide opportunities for colleagues living in distant locations to connect; share best practices, common goals, and challenges; and initiate ongoing and lasting relationships. The Conference draws the most diverse audience by discipline of all the VA ECHO conferences hosted at VACT (Table 2). 

Traditionally, the national VA ECHO program has been a forum for specialists to discuss clinical case presentations for the benefit of primary care providers and to deliver didactics about chronic clinical conditions. Our Cancer Care Management VA ECHO has explored new ground by discussing material that has helped sites set up and enhance cancer care clinics and disseminate best practices for cancer survivorship and other aspects of cancer care. As a result, this conference has attracted and provided a forum for the most diverse audience of staff among VA ECHO clinics, with participation from clinic administrators to social workers to primary care providers to tumor registrars.

Through the creation of the Conference, > 300 individuals who care for veterans with cancer have been provided with a regular forum at which to connect with colleagues, receive updates on new treatment options for their patients, and learn about and share best practices specific to VA oncology patients. The VA ECHO technology creates a resource that can be accessed by all VA staff from their desktop computer. The VA ECHO SharePoint saves the slides of the Conference presentations both with and without audio to enable staff who can’t participate in real time to access the information at their convenience.

The Conference has facilitated networking among VA oncology providers who have common interests. Conference participants also have participated in other VA ECHO conferences in disciplines beyond oncology. Participants in the Conference also are encouraged to participate as speakers by presenting quality improvement initiatives at their VA site. This novel approach to generating content for this educational series has led to a dynamic interchange of ideas and increased networking among VA providers related to their practice and quality improvement initiatives at their VA sites. The Conference provides a regular forum for VA staff across a wide range of disciplines to share personal experiences, successes, and frustrations and to get feedback from colleagues.

The Conference combines a structured approach to presenting VA-specific educational content related to cancer care and multiple mechanisms that encourage staff to participate in an ongoing dialogue related to quality initiatives both on the phone during the Conference, online using Outlook LYNC or Skype to ask questions during the Conference, and during conversations on group e-mail. The Conference promotes staff engagement at little or no extra cost to the VA. For more information about the VA ECHO Cancer Care Conference or to submit a presentation for consideration for a future session, please contact julie.beck@va.gov or pradeep.mutalik@va.gov.

In 2016, the Cancer Care Coordinator at the US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACT) in West Haven partnered with the VA New England Healthcare System to use its telementoring program. The VA Specialty Care Access Network Extension for Community Healthcare Outcomes (VA ECHO) was used to present a series of educational conferences on cancer care. This article describes our experience implementing the program and reviews participant feedback gathered from voluntary surveys.

Background

In 2011, the Veterans Health Administration (VHA) Office of Healthcare Transformation launched VA ECHO, a telementoring program for primary care providers (PCPs) and patient-aligned care team staff. VACT was selected as 1 of 7 hub sites across the US. The VA ECHO system uses video and online technology to provide PCPs with case-based specialist consultation and didactic education. The system enables providers at any VA location to participate in online and telephone conferences in real time. The presentations are recorded and made available online to VA providers through a secure site.

VA ECHO is based on the highly successful Project ECHO model established by Sanjeev Arora and the University of New Mexico in 2007.¹ The rationale for Project ECHO was that patient care could be improved by increasing the competence of PCPs in the management of complex diseases by providing access to disease specialists through a case-based learning approach that used technology, which it termed knowledge networks, to connect the PCPs to specialists.

The original model addressed management of hepatitis C in a medically underserved area where half of the population was widely geographically dispersed, making the provision of specialty care challenging. Developers identified 6 characteristics that make a disease appropriate for treatment using the Project ECHO knowledge network model:

• The disease is common;
• Management of the disease is complex;
• Treatment for the disease is evolving;
• The disease has a high societal impact;
• There are serious outcomes if the disease is not treated; and
• Disease management improves outcomes.¹

VA ECHO conferences are available to all VA personnel. Staff can subscribe to an e-mail group list to be alerted to conference times and topics. Participants can connect directly to the conference using Microsoft Outlook Lync or Skype (Redmond, WA) and see the slides in real time on their computer as they listen to the presentation. The presentations are recorded, and the slides with audio can be accessed easily on the VA ECHO SharePoint site for download, enabling VA staff to listen to conferences at their convenience (Figure).

VA Cancer ECHO

The impetus to create a series of talks related to cancer care using VA ECHO was the frequent and often time-consuming requests we received from colleagues at other VA sites for information about areas of cancer care, such as survivorship and cancer care coordination. It was felt that presenting cancer care information as a VA ECHO series would make this information available to a large group of providers at one time, making the method more time effective than sharing the information via one-on-one conversations.

The cancer care coordinator originally conceived this as a 3-part, 1-time series to present work done at VACT in the areas of survivorship, psychosocial distress monitoring, and coordination of cancer care using the VA Cancer Care Tracking System, an online tracking tool. Information about the series was disseminated via VA group e-mail lists for oncology providers and via the existing VA ECHO subscriber invitation process. The 3-presentation series garnered positive feedback and had attendance that ranged from 49 to 75 participants (mean, 60). Participants expressed enthusiasm for the format via e-mail and phone feedback directly to the West Haven staff.

Expansion

The success of this original 3-part series led to a trial of an ongoing Cancer Care Conference series (Conference) using VA ECHO. This was a novel use of VA ECHO and was outside its traditional format, which is geared to discussion of individual cases and clinical knowledge. Nevertheless, this new style of communication has been embraced by a wide range of VA cancer care professionals.

One reason we considered expanding the program was that oncology fit the framework of the original Project ECHO knowledge network model. Cancer is common at the VA, which cares for 175,000 patients with cancer annually.² The management of cancer is complex involving many disciplines working together, and treatments are constantly changing. In addition, cancer has a high societal impact; there are serious outcomes both in terms of patient survival and patient symptom burden. And lastly, outcomes are improved with proactive disease management that is informed by the most current, evidence-based medicine.

The Conference was conceived as a forum for providers across disciplines to share best practices and discuss common challenges in caring for veterans with cancer. We invited participants to submit proposals for presentations related to cancer care initiatives at their VA sites. Potential speakers across all areas of care for veterans with cancer were invited to submit possible topics for the conference. The submissions were reviewed by the moderators in an effort to create a series of talks on a variety of topics across all aspects of care for oncology patients in the VA. This process of effectively crowd-sourcing educational content inspires providers to think more creatively about their practice and quality improvement projects and has sparked an ongoing dialogue about quality initiatives among VA oncology providers across disciplines and geographic locations. As a result, this approach also has enabled participants to learn from colleagues who work at a wide range of rural and urban VA locations throughout the country and to network with colleagues who are working on similar quality initiatives and challenges related to caring for veterans with cancer.

Program

The first Conference talk was in October 2016. It encompassed ten 1-hour talks during the 2016 to 2017 academic year. Speakers were recruited from the VACT West Haven campus and from several other VA sites nationwide. Topics included survivorship, psychosocial distress, palliative care, cancer navigation, and establishing a clinical trials program.

In its first year, the Conference series had 260 unique attendees representing such disciplines as medicine, nursing, social work, pharmacy, psychology, and clinic administration and representing all 21 Veterans Integrated Services Networks (VISNs). Speakers including oncologists, hepatologists, cancer care coordinators, health psychologists, and a research coordinator gave presentations on psychosocial distress screening and issues, cognitive behavioral therapy for cancer pain, cancer navigation, cancer case tracking, VISN-based liver cancer tumor tracker and liver tumor board, starting a VA-based clinical trial, palliative care, and survivorship.

The Conference accounted for 508 continuing medical education (CME) hours, which accounted for one-third of the total CME hours generated by the VACT West Haven VA ECHO program. Highlights of the talks were presented at the 2017 Association of VA Hematology/Oncology annual meeting in Denver, Colorado.

During the second year of the Conference, speakers were recruited to address new American College of Surgeons Commission on Cancer (CoC) requirements regarding survivorship treatment summaries for a subset of cancer survivors.³ The focus on survivorship was driven by ongoing feedback from participants who were working on initiatives to implement this process at their VA sites and wanted to learn from peers involved in this process throughout the VA system. Several speakers gave talks on implementing survivorship care at their VA and specifically on the use of computerized patient record system templates to create survivorship treatment summaries for veterans in accordance with CoC standards.

Since the first Conference in 2016, the number of unique attendees grew by 20% to 327 in 2018. During its first 2 years, participants have earned a total of 1,095 CME credits through Yale University CME. Conferences are usually broadcast at noon eastern time so that providers can take advantage of sessions during lunch breaks.

Participant Surveys

Attendees were invited to participate in voluntary, anonymous surveys to obtain feedback on and to receive input on topics of interest for future talks. Participants also were asked to comment on resources that they utilized to be updated on practice changes (Table 1). 

The Conference has led to increased awareness of other continuing education opportunities available through VA ECHO-Connecticut. Of survey participants, 20% reported that they had attended other VA ECHO conferences.

The survey samples are self-selecting and may not necessarily be representative of the Conference participants or of the VA oncology interdisciplinary team as a whole; however, the relatively large number of survey participants provides some confidence that these survey results can help inform future planning for this and other continuing education opportunities for VA oncology providers.

An additional online survey was designed to elucidate whether participants were incorporating knowledge gained from the Conference in their cancer care practice. Half of the 32 participants strongly agreed with the following statement: “Participation in the VA Cancer Care Conference has added to my knowledge of information relevant to my practice,” and 13 more agreed with the statement for a total of 90.6% of those surveyed responding affirmatively. Only 3 participants neither agreed nor disagreed, and none disagreed with the statement. More than half of the participants reported that they made changes to their practice or plan to make changes as a result of the Conference.

Conculsion

The VA ECHO program established at the VACT West Haven campus in 2012 now offers regular monthly or bimonthly conferences in 9 specialties: pain, liver/hepatitis C, neurology, nephrology, cardiology, diabetes/endocrinology, mental health and addiction, nursing grand rounds, and cancer care. The VACT ECHO program is led by a medical director, and each specialty has a clinical director who conducts sessions and recruits other specialists from their department.

Teleconferencing can provide opportunities for colleagues living in distant locations to connect; share best practices, common goals, and challenges; and initiate ongoing and lasting relationships. The Conference draws the most diverse audience by discipline of all the VA ECHO conferences hosted at VACT (Table 2). 

Traditionally, the national VA ECHO program has been a forum for specialists to discuss clinical case presentations for the benefit of primary care providers and to deliver didactics about chronic clinical conditions. Our Cancer Care Management VA ECHO has explored new ground by discussing material that has helped sites set up and enhance cancer care clinics and disseminate best practices for cancer survivorship and other aspects of cancer care. As a result, this conference has attracted and provided a forum for the most diverse audience of staff among VA ECHO clinics, with participation from clinic administrators to social workers to primary care providers to tumor registrars.

Through the creation of the Conference, > 300 individuals who care for veterans with cancer have been provided with a regular forum at which to connect with colleagues, receive updates on new treatment options for their patients, and learn about and share best practices specific to VA oncology patients. The VA ECHO technology creates a resource that can be accessed by all VA staff from their desktop computer. The VA ECHO SharePoint saves the slides of the Conference presentations both with and without audio to enable staff who can’t participate in real time to access the information at their convenience.

The Conference has facilitated networking among VA oncology providers who have common interests. Conference participants also have participated in other VA ECHO conferences in disciplines beyond oncology. Participants in the Conference also are encouraged to participate as speakers by presenting quality improvement initiatives at their VA site. This novel approach to generating content for this educational series has led to a dynamic interchange of ideas and increased networking among VA providers related to their practice and quality improvement initiatives at their VA sites. The Conference provides a regular forum for VA staff across a wide range of disciplines to share personal experiences, successes, and frustrations and to get feedback from colleagues.

The Conference combines a structured approach to presenting VA-specific educational content related to cancer care and multiple mechanisms that encourage staff to participate in an ongoing dialogue related to quality initiatives both on the phone during the Conference, online using Outlook LYNC or Skype to ask questions during the Conference, and during conversations on group e-mail. The Conference promotes staff engagement at little or no extra cost to the VA. For more information about the VA ECHO Cancer Care Conference or to submit a presentation for consideration for a future session, please contact julie.beck@va.gov or pradeep.mutalik@va.gov.

In 2016, the Cancer Care Coordinator at the US Department of Veterans Affairs (VA) Connecticut Healthcare System (VACT) in West Haven partnered with the VA New England Healthcare System to use its telementoring program. The VA Specialty Care Access Network Extension for Community Healthcare Outcomes (VA ECHO) was used to present a series of educational conferences on cancer care. This article describes our experience implementing the program and reviews participant feedback gathered from voluntary surveys.

Background

In 2011, the Veterans Health Administration (VHA) Office of Healthcare Transformation launched VA ECHO, a telementoring program for primary care providers (PCPs) and patient-aligned care team staff. VACT was selected as 1 of 7 hub sites across the US. The VA ECHO system uses video and online technology to provide PCPs with case-based specialist consultation and didactic education. The system enables providers at any VA location to participate in online and telephone conferences in real time. The presentations are recorded and made available online to VA providers through a secure site.

VA ECHO is based on the highly successful Project ECHO model established by Sanjeev Arora and the University of New Mexico in 2007.¹ The rationale for Project ECHO was that patient care could be improved by increasing the competence of PCPs in the management of complex diseases by providing access to disease specialists through a case-based learning approach that used technology, which it termed knowledge networks, to connect the PCPs to specialists.

The original model addressed management of hepatitis C in a medically underserved area where half of the population was widely geographically dispersed, making the provision of specialty care challenging. Developers identified 6 characteristics that make a disease appropriate for treatment using the Project ECHO knowledge network model:

• The disease is common;
• Management of the disease is complex;
• Treatment for the disease is evolving;
• The disease has a high societal impact;
• There are serious outcomes if the disease is not treated; and
• Disease management improves outcomes.¹

VA ECHO conferences are available to all VA personnel. Staff can subscribe to an e-mail group list to be alerted to conference times and topics. Participants can connect directly to the conference using Microsoft Outlook Lync or Skype (Redmond, WA) and see the slides in real time on their computer as they listen to the presentation. The presentations are recorded, and the slides with audio can be accessed easily on the VA ECHO SharePoint site for download, enabling VA staff to listen to conferences at their convenience (Figure).

VA Cancer ECHO

The impetus to create a series of talks related to cancer care using VA ECHO was the frequent and often time-consuming requests we received from colleagues at other VA sites for information about areas of cancer care, such as survivorship and cancer care coordination. It was felt that presenting cancer care information as a VA ECHO series would make this information available to a large group of providers at one time, making the method more time effective than sharing the information via one-on-one conversations.

The cancer care coordinator originally conceived this as a 3-part, 1-time series to present work done at VACT in the areas of survivorship, psychosocial distress monitoring, and coordination of cancer care using the VA Cancer Care Tracking System, an online tracking tool. Information about the series was disseminated via VA group e-mail lists for oncology providers and via the existing VA ECHO subscriber invitation process. The 3-presentation series garnered positive feedback and had attendance that ranged from 49 to 75 participants (mean, 60). Participants expressed enthusiasm for the format via e-mail and phone feedback directly to the West Haven staff.

Expansion

The success of this original 3-part series led to a trial of an ongoing Cancer Care Conference series (Conference) using VA ECHO. This was a novel use of VA ECHO and was outside its traditional format, which is geared to discussion of individual cases and clinical knowledge. Nevertheless, this new style of communication has been embraced by a wide range of VA cancer care professionals.

One reason we considered expanding the program was that oncology fit the framework of the original Project ECHO knowledge network model. Cancer is common at the VA, which cares for 175,000 patients with cancer annually.² The management of cancer is complex involving many disciplines working together, and treatments are constantly changing. In addition, cancer has a high societal impact; there are serious outcomes both in terms of patient survival and patient symptom burden. And lastly, outcomes are improved with proactive disease management that is informed by the most current, evidence-based medicine.

The Conference was conceived as a forum for providers across disciplines to share best practices and discuss common challenges in caring for veterans with cancer. We invited participants to submit proposals for presentations related to cancer care initiatives at their VA sites. Potential speakers across all areas of care for veterans with cancer were invited to submit possible topics for the conference. The submissions were reviewed by the moderators in an effort to create a series of talks on a variety of topics across all aspects of care for oncology patients in the VA. This process of effectively crowd-sourcing educational content inspires providers to think more creatively about their practice and quality improvement projects and has sparked an ongoing dialogue about quality initiatives among VA oncology providers across disciplines and geographic locations. As a result, this approach also has enabled participants to learn from colleagues who work at a wide range of rural and urban VA locations throughout the country and to network with colleagues who are working on similar quality initiatives and challenges related to caring for veterans with cancer.

Program

The first Conference talk was in October 2016. It encompassed ten 1-hour talks during the 2016 to 2017 academic year. Speakers were recruited from the VACT West Haven campus and from several other VA sites nationwide. Topics included survivorship, psychosocial distress, palliative care, cancer navigation, and establishing a clinical trials program.

In its first year, the Conference series had 260 unique attendees representing such disciplines as medicine, nursing, social work, pharmacy, psychology, and clinic administration and representing all 21 Veterans Integrated Services Networks (VISNs). Speakers including oncologists, hepatologists, cancer care coordinators, health psychologists, and a research coordinator gave presentations on psychosocial distress screening and issues, cognitive behavioral therapy for cancer pain, cancer navigation, cancer case tracking, VISN-based liver cancer tumor tracker and liver tumor board, starting a VA-based clinical trial, palliative care, and survivorship.

The Conference accounted for 508 continuing medical education (CME) hours, which accounted for one-third of the total CME hours generated by the VACT West Haven VA ECHO program. Highlights of the talks were presented at the 2017 Association of VA Hematology/Oncology annual meeting in Denver, Colorado.

During the second year of the Conference, speakers were recruited to address new American College of Surgeons Commission on Cancer (CoC) requirements regarding survivorship treatment summaries for a subset of cancer survivors.³ The focus on survivorship was driven by ongoing feedback from participants who were working on initiatives to implement this process at their VA sites and wanted to learn from peers involved in this process throughout the VA system. Several speakers gave talks on implementing survivorship care at their VA and specifically on the use of computerized patient record system templates to create survivorship treatment summaries for veterans in accordance with CoC standards.

Since the first Conference in 2016, the number of unique attendees grew by 20% to 327 in 2018. During its first 2 years, participants have earned a total of 1,095 CME credits through Yale University CME. Conferences are usually broadcast at noon eastern time so that providers can take advantage of sessions during lunch breaks.

Participant Surveys

Attendees were invited to participate in voluntary, anonymous surveys to obtain feedback on and to receive input on topics of interest for future talks. Participants also were asked to comment on resources that they utilized to be updated on practice changes (Table 1). 

The Conference has led to increased awareness of other continuing education opportunities available through VA ECHO-Connecticut. Of survey participants, 20% reported that they had attended other VA ECHO conferences.

The survey samples are self-selecting and may not necessarily be representative of the Conference participants or of the VA oncology interdisciplinary team as a whole; however, the relatively large number of survey participants provides some confidence that these survey results can help inform future planning for this and other continuing education opportunities for VA oncology providers.

An additional online survey was designed to elucidate whether participants were incorporating knowledge gained from the Conference in their cancer care practice. Half of the 32 participants strongly agreed with the following statement: “Participation in the VA Cancer Care Conference has added to my knowledge of information relevant to my practice,” and 13 more agreed with the statement for a total of 90.6% of those surveyed responding affirmatively. Only 3 participants neither agreed nor disagreed, and none disagreed with the statement. More than half of the participants reported that they made changes to their practice or plan to make changes as a result of the Conference.

Conculsion

The VA ECHO program established at the VACT West Haven campus in 2012 now offers regular monthly or bimonthly conferences in 9 specialties: pain, liver/hepatitis C, neurology, nephrology, cardiology, diabetes/endocrinology, mental health and addiction, nursing grand rounds, and cancer care. The VACT ECHO program is led by a medical director, and each specialty has a clinical director who conducts sessions and recruits other specialists from their department.

Teleconferencing can provide opportunities for colleagues living in distant locations to connect; share best practices, common goals, and challenges; and initiate ongoing and lasting relationships. The Conference draws the most diverse audience by discipline of all the VA ECHO conferences hosted at VACT (Table 2). 

Traditionally, the national VA ECHO program has been a forum for specialists to discuss clinical case presentations for the benefit of primary care providers and to deliver didactics about chronic clinical conditions. Our Cancer Care Management VA ECHO has explored new ground by discussing material that has helped sites set up and enhance cancer care clinics and disseminate best practices for cancer survivorship and other aspects of cancer care. As a result, this conference has attracted and provided a forum for the most diverse audience of staff among VA ECHO clinics, with participation from clinic administrators to social workers to primary care providers to tumor registrars.

Through the creation of the Conference, > 300 individuals who care for veterans with cancer have been provided with a regular forum at which to connect with colleagues, receive updates on new treatment options for their patients, and learn about and share best practices specific to VA oncology patients. The VA ECHO technology creates a resource that can be accessed by all VA staff from their desktop computer. The VA ECHO SharePoint saves the slides of the Conference presentations both with and without audio to enable staff who can’t participate in real time to access the information at their convenience.

The Conference has facilitated networking among VA oncology providers who have common interests. Conference participants also have participated in other VA ECHO conferences in disciplines beyond oncology. Participants in the Conference also are encouraged to participate as speakers by presenting quality improvement initiatives at their VA site. This novel approach to generating content for this educational series has led to a dynamic interchange of ideas and increased networking among VA providers related to their practice and quality improvement initiatives at their VA sites. The Conference provides a regular forum for VA staff across a wide range of disciplines to share personal experiences, successes, and frustrations and to get feedback from colleagues.

The Conference combines a structured approach to presenting VA-specific educational content related to cancer care and multiple mechanisms that encourage staff to participate in an ongoing dialogue related to quality initiatives both on the phone during the Conference, online using Outlook LYNC or Skype to ask questions during the Conference, and during conversations on group e-mail. The Conference promotes staff engagement at little or no extra cost to the VA. For more information about the VA ECHO Cancer Care Conference or to submit a presentation for consideration for a future session, please contact julie.beck@va.gov or pradeep.mutalik@va.gov.

The COVID-19 pandemic is posing significant challenges while also providing unique opportunities for patients with substance use disorders (SUD), a leading expert says.

Nora Volkow, MD, director of the National Institute on Drug Abuse, said that the pandemic has accelerated the use of telemedicine, making it easier for patients with SUD to access treatment. It has also led to the proliferation of more mental health hotlines, which is critical since the vast majority of these patients have comorbid mental illness.

In addition, COVID-19 has resulted in increased availability of “alternative” peer support mechanisms via cellphones or computers to aid individuals’ sobriety.

Dr. Volkow spoke at the virtual American Psychiatric Association Spring Highlights Meeting 2020, which is replacing the organization’s canceled annual meeting.

While methadone clinics have had to close during the pandemic, making it challenging for those on medically assisted treatment to receive methadone or buprenorphine, some of the rules and regulations have been relaxed in order to make these medications accessible without the need for in-person attendance at a clinic. In addition, the Substance Abuse and Mental Health Services Administration has relaxed some of its own regulations regarding telehealth and opioid treatment programs.
 

Social isolation, stigma intensified

A pandemic increases anxiety in the general population, but for patients with SUD who may be also be struggling with homelessness and comorbid mental illness, the situation can further exacerbate social stigma and isolation – leading to relapse, more overdoses, and overdose deaths, Dr. Volkow said. Social interaction is “extraordinarily important” for patients and “one of the most powerful tools we have” to build resilience.

Right now, said Dr. Volkow, “we are in the dark as to how COVID infections have affected the number of overdose deaths.”

However, she noted that NIDA has issued a Notice of Special Interest to spur “urgent” research into how COVID-19 is affecting outcomes in patients with SUD.

“So even through this devastation, we can actually extract something that may help others in future,” she said.

Dr. Volkow noted that during the pandemic it is critical to reinforce the importance of engaging in – and remaining in – treatment to SUD patients. It’s also crucial to make patients aware of social support systems and behavioral interventions to help them cope with stress and to mitigate relapse risk.
 

COVID-19 and relapse

Elie G. Aoun, MD, assistant professor of psychiatry at New York University and vice chair of the APA’s Council on Addiction Psychiatry, said in an interview that Dr. Volkow’s presentation provided “exactly the kind of accessible information” clinicians need.

Dr. Aoun said he sees the impact of the COVID-19 crisis in his practice every day. Patients with SUD “are getting the short end of the stick.”

Social distancing measures prompted by the pandemic can be “very triggering” for SUD patients, he said. One of his patients told him the current isolation, loneliness, movement restrictions, and boredom remind her of the way she felt when she used drugs.

Dr. Aoun said four of his patients have relapsed since the pandemic began. Two of them had just started treatment after years of using drugs, so this was a “major setback” for them.

He and his colleagues were “not really prepared” to provide care via video link, which he believes is not as effective as in-person sessions.

In addition to disrupting patient care, said Dr. Aoun, the pandemic is forcing the medical community to face social determinants of health, such as poverty and homelessness, as they relate to addiction disorders and whether or not someone receives care.

This article originally appeared on Medscape.com.

The COVID-19 pandemic is posing significant challenges while also providing unique opportunities for patients with substance use disorders (SUD), a leading expert says.

Nora Volkow, MD, director of the National Institute on Drug Abuse, said that the pandemic has accelerated the use of telemedicine, making it easier for patients with SUD to access treatment. It has also led to the proliferation of more mental health hotlines, which is critical since the vast majority of these patients have comorbid mental illness.

In addition, COVID-19 has resulted in increased availability of “alternative” peer support mechanisms via cellphones or computers to aid individuals’ sobriety.

Dr. Volkow spoke at the virtual American Psychiatric Association Spring Highlights Meeting 2020, which is replacing the organization’s canceled annual meeting.

While methadone clinics have had to close during the pandemic, making it challenging for those on medically assisted treatment to receive methadone or buprenorphine, some of the rules and regulations have been relaxed in order to make these medications accessible without the need for in-person attendance at a clinic. In addition, the Substance Abuse and Mental Health Services Administration has relaxed some of its own regulations regarding telehealth and opioid treatment programs.
 

Social isolation, stigma intensified

A pandemic increases anxiety in the general population, but for patients with SUD who may be also be struggling with homelessness and comorbid mental illness, the situation can further exacerbate social stigma and isolation – leading to relapse, more overdoses, and overdose deaths, Dr. Volkow said. Social interaction is “extraordinarily important” for patients and “one of the most powerful tools we have” to build resilience.

Right now, said Dr. Volkow, “we are in the dark as to how COVID infections have affected the number of overdose deaths.”

However, she noted that NIDA has issued a Notice of Special Interest to spur “urgent” research into how COVID-19 is affecting outcomes in patients with SUD.

“So even through this devastation, we can actually extract something that may help others in future,” she said.

Dr. Volkow noted that during the pandemic it is critical to reinforce the importance of engaging in – and remaining in – treatment to SUD patients. It’s also crucial to make patients aware of social support systems and behavioral interventions to help them cope with stress and to mitigate relapse risk.
 

COVID-19 and relapse

Elie G. Aoun, MD, assistant professor of psychiatry at New York University and vice chair of the APA’s Council on Addiction Psychiatry, said in an interview that Dr. Volkow’s presentation provided “exactly the kind of accessible information” clinicians need.

Dr. Aoun said he sees the impact of the COVID-19 crisis in his practice every day. Patients with SUD “are getting the short end of the stick.”

Social distancing measures prompted by the pandemic can be “very triggering” for SUD patients, he said. One of his patients told him the current isolation, loneliness, movement restrictions, and boredom remind her of the way she felt when she used drugs.

Dr. Aoun said four of his patients have relapsed since the pandemic began. Two of them had just started treatment after years of using drugs, so this was a “major setback” for them.

He and his colleagues were “not really prepared” to provide care via video link, which he believes is not as effective as in-person sessions.

In addition to disrupting patient care, said Dr. Aoun, the pandemic is forcing the medical community to face social determinants of health, such as poverty and homelessness, as they relate to addiction disorders and whether or not someone receives care.

This article originally appeared on Medscape.com.

The COVID-19 pandemic is posing significant challenges while also providing unique opportunities for patients with substance use disorders (SUD), a leading expert says.

Nora Volkow, MD, director of the National Institute on Drug Abuse, said that the pandemic has accelerated the use of telemedicine, making it easier for patients with SUD to access treatment. It has also led to the proliferation of more mental health hotlines, which is critical since the vast majority of these patients have comorbid mental illness.

In addition, COVID-19 has resulted in increased availability of “alternative” peer support mechanisms via cellphones or computers to aid individuals’ sobriety.

Dr. Volkow spoke at the virtual American Psychiatric Association Spring Highlights Meeting 2020, which is replacing the organization’s canceled annual meeting.

While methadone clinics have had to close during the pandemic, making it challenging for those on medically assisted treatment to receive methadone or buprenorphine, some of the rules and regulations have been relaxed in order to make these medications accessible without the need for in-person attendance at a clinic. In addition, the Substance Abuse and Mental Health Services Administration has relaxed some of its own regulations regarding telehealth and opioid treatment programs.
 

Social isolation, stigma intensified

A pandemic increases anxiety in the general population, but for patients with SUD who may be also be struggling with homelessness and comorbid mental illness, the situation can further exacerbate social stigma and isolation – leading to relapse, more overdoses, and overdose deaths, Dr. Volkow said. Social interaction is “extraordinarily important” for patients and “one of the most powerful tools we have” to build resilience.

Right now, said Dr. Volkow, “we are in the dark as to how COVID infections have affected the number of overdose deaths.”

However, she noted that NIDA has issued a Notice of Special Interest to spur “urgent” research into how COVID-19 is affecting outcomes in patients with SUD.

“So even through this devastation, we can actually extract something that may help others in future,” she said.

Dr. Volkow noted that during the pandemic it is critical to reinforce the importance of engaging in – and remaining in – treatment to SUD patients. It’s also crucial to make patients aware of social support systems and behavioral interventions to help them cope with stress and to mitigate relapse risk.
 

COVID-19 and relapse

Elie G. Aoun, MD, assistant professor of psychiatry at New York University and vice chair of the APA’s Council on Addiction Psychiatry, said in an interview that Dr. Volkow’s presentation provided “exactly the kind of accessible information” clinicians need.

Dr. Aoun said he sees the impact of the COVID-19 crisis in his practice every day. Patients with SUD “are getting the short end of the stick.”

Social distancing measures prompted by the pandemic can be “very triggering” for SUD patients, he said. One of his patients told him the current isolation, loneliness, movement restrictions, and boredom remind her of the way she felt when she used drugs.

Dr. Aoun said four of his patients have relapsed since the pandemic began. Two of them had just started treatment after years of using drugs, so this was a “major setback” for them.

He and his colleagues were “not really prepared” to provide care via video link, which he believes is not as effective as in-person sessions.

In addition to disrupting patient care, said Dr. Aoun, the pandemic is forcing the medical community to face social determinants of health, such as poverty and homelessness, as they relate to addiction disorders and whether or not someone receives care.

This article originally appeared on Medscape.com.

The U.S. Food and Drug Administration reinforced its March guidance on when it’s permissible to use hydroxychloroquine and chloroquine to treat COVID-19 patients and on the multiple risks these drugs pose in a Safety Communication on April 24.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The new communication reiterated the agency’s position from the Emergency Use Authorization (EUA) it granted on March 28 to allow hydroxychloroquine and chloroquine treatment of COVID-19 patients only when they are hospitalized and participation in a clinical trial is “not available,” or “not feasible.” The April 24 update to the EUA noted that “the FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines. We are also aware of increased use of these medicines through outpatient prescriptions.”

In addition to reiterating the prior limitations on permissible patients for these treatment the agency also said in the new communication that “close supervision is strongly recommended, “ specifying that “we recommend initial evaluation and monitoring when using hydroxychloroquine or chloroquine under the EUA or in clinical trials that investigate these medicines for the treatment or prevention of COVID-19. Monitoring may include baseline ECG, electrolytes, renal function, and hepatic tests.” The communication also highlighted several potential serious adverse effects from hydroxychloroquine or chloroquine that include QT prolongation with increased risk in patients with renal insufficiency or failure, increased insulin levels and insulin action causing increased risk of severe hypoglycemia, hemolysis in selected patients, and interaction with other medicines that cause QT prolongation.

“If a healthcare professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and consider enrolling the patient,” the statement added.

The FDA’s Safety Communication came a day after the European Medicines Agency issued a similar reminder about the risk for serious adverse effects from treatment with hydroxychloroquine and chloroquine, the need for adverse effect monitoring, and the unproven status of purported benefits from these agents.

The statement came after ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite a lack of evidence.

The FDA’s communication cited recent case reports sent to the FDA, as well as published findings, and reports to the National Poison Data System that have described serious, heart-related adverse events and death in COVID-19 patients who received hydroxychloroquine and chloroquine, alone or in combination with azithromycin or another QT-prolonging drug. One recent, notable but not peer-reviewed report on 368 patients treated at any of several U.S. VA medical centers showed no apparent benefit to hospitalized COVID-19 patients treated with hydroxychloroquine and a signal for increased mortality among certain patients on this drug (medRxiv. 2020 Apr 23; doi: 10.1101/2020.04.16.20065920). Several cardiology societies have also highlighted the cardiac considerations for using these drugs in patients with COVID-19, including a summary coauthored by the presidents of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society (Circulation. 2020 Apr 8. doi: 10.1161/CIRCULATIONAHA.120.047521), and in guidance from the European Society of Cardiology.

mzoler@mdedge.com

The U.S. Food and Drug Administration reinforced its March guidance on when it’s permissible to use hydroxychloroquine and chloroquine to treat COVID-19 patients and on the multiple risks these drugs pose in a Safety Communication on April 24.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The new communication reiterated the agency’s position from the Emergency Use Authorization (EUA) it granted on March 28 to allow hydroxychloroquine and chloroquine treatment of COVID-19 patients only when they are hospitalized and participation in a clinical trial is “not available,” or “not feasible.” The April 24 update to the EUA noted that “the FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines. We are also aware of increased use of these medicines through outpatient prescriptions.”

In addition to reiterating the prior limitations on permissible patients for these treatment the agency also said in the new communication that “close supervision is strongly recommended, “ specifying that “we recommend initial evaluation and monitoring when using hydroxychloroquine or chloroquine under the EUA or in clinical trials that investigate these medicines for the treatment or prevention of COVID-19. Monitoring may include baseline ECG, electrolytes, renal function, and hepatic tests.” The communication also highlighted several potential serious adverse effects from hydroxychloroquine or chloroquine that include QT prolongation with increased risk in patients with renal insufficiency or failure, increased insulin levels and insulin action causing increased risk of severe hypoglycemia, hemolysis in selected patients, and interaction with other medicines that cause QT prolongation.

“If a healthcare professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and consider enrolling the patient,” the statement added.

The FDA’s Safety Communication came a day after the European Medicines Agency issued a similar reminder about the risk for serious adverse effects from treatment with hydroxychloroquine and chloroquine, the need for adverse effect monitoring, and the unproven status of purported benefits from these agents.

The statement came after ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite a lack of evidence.

The FDA’s communication cited recent case reports sent to the FDA, as well as published findings, and reports to the National Poison Data System that have described serious, heart-related adverse events and death in COVID-19 patients who received hydroxychloroquine and chloroquine, alone or in combination with azithromycin or another QT-prolonging drug. One recent, notable but not peer-reviewed report on 368 patients treated at any of several U.S. VA medical centers showed no apparent benefit to hospitalized COVID-19 patients treated with hydroxychloroquine and a signal for increased mortality among certain patients on this drug (medRxiv. 2020 Apr 23; doi: 10.1101/2020.04.16.20065920). Several cardiology societies have also highlighted the cardiac considerations for using these drugs in patients with COVID-19, including a summary coauthored by the presidents of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society (Circulation. 2020 Apr 8. doi: 10.1161/CIRCULATIONAHA.120.047521), and in guidance from the European Society of Cardiology.

mzoler@mdedge.com

The U.S. Food and Drug Administration reinforced its March guidance on when it’s permissible to use hydroxychloroquine and chloroquine to treat COVID-19 patients and on the multiple risks these drugs pose in a Safety Communication on April 24.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The new communication reiterated the agency’s position from the Emergency Use Authorization (EUA) it granted on March 28 to allow hydroxychloroquine and chloroquine treatment of COVID-19 patients only when they are hospitalized and participation in a clinical trial is “not available,” or “not feasible.” The April 24 update to the EUA noted that “the FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines. We are also aware of increased use of these medicines through outpatient prescriptions.”

In addition to reiterating the prior limitations on permissible patients for these treatment the agency also said in the new communication that “close supervision is strongly recommended, “ specifying that “we recommend initial evaluation and monitoring when using hydroxychloroquine or chloroquine under the EUA or in clinical trials that investigate these medicines for the treatment or prevention of COVID-19. Monitoring may include baseline ECG, electrolytes, renal function, and hepatic tests.” The communication also highlighted several potential serious adverse effects from hydroxychloroquine or chloroquine that include QT prolongation with increased risk in patients with renal insufficiency or failure, increased insulin levels and insulin action causing increased risk of severe hypoglycemia, hemolysis in selected patients, and interaction with other medicines that cause QT prolongation.

“If a healthcare professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and consider enrolling the patient,” the statement added.

The FDA’s Safety Communication came a day after the European Medicines Agency issued a similar reminder about the risk for serious adverse effects from treatment with hydroxychloroquine and chloroquine, the need for adverse effect monitoring, and the unproven status of purported benefits from these agents.

The statement came after ongoing promotion by the Trump administration of hydroxychloroquine, in particular, for COVID-19 despite a lack of evidence.

The FDA’s communication cited recent case reports sent to the FDA, as well as published findings, and reports to the National Poison Data System that have described serious, heart-related adverse events and death in COVID-19 patients who received hydroxychloroquine and chloroquine, alone or in combination with azithromycin or another QT-prolonging drug. One recent, notable but not peer-reviewed report on 368 patients treated at any of several U.S. VA medical centers showed no apparent benefit to hospitalized COVID-19 patients treated with hydroxychloroquine and a signal for increased mortality among certain patients on this drug (medRxiv. 2020 Apr 23; doi: 10.1101/2020.04.16.20065920). Several cardiology societies have also highlighted the cardiac considerations for using these drugs in patients with COVID-19, including a summary coauthored by the presidents of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society (Circulation. 2020 Apr 8. doi: 10.1161/CIRCULATIONAHA.120.047521), and in guidance from the European Society of Cardiology.

mzoler@mdedge.com