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The Official Newspaper of the American Association for Thoracic Surgery
First-in-class glutaminase inhibitor combats anti-PD-1/PD-L1 resistance
NATIONAL HARBOR, MD. – Combination treatment with the first-in-class glutaminase inhibitor CB-839 and nivolumab is well-tolerated and shows clinical activity in patients with advanced melanoma, renal cell carcinoma, or non-small cell lung cancer, including anti-PD-1/PD-L1 refractory patients, according to initial results from a phase 1/2 study.
Responses in melanoma patients who were progressing on nivolumab at study entry and who were refractory to multiple prior immunotherapy regimens are particularly notable, as they highlight the potential for CB-839, when added to nivolumab (Opdivo), to help overcome resistance to anti-PD-L1 therapy, Funda Meric‐Bernstam, MD, reported at the annual meeting of the Society for Immunotherapy of Cancer.
CB‐839 is highly selective and targets tumor glutamine metabolism, said Dr. Meric-Bernstam of the University of Texas MD Anderson Cancer Center, Houston.
Competition between tumor cells and immune cells for nutrients such as glutamine in the tumor microenvironment can create a metabolic checkpoint that induces local immune suppression. CB‐839 inhibits tumor glutamine consumption, thereby increasing glutamine availability to support T‐cell activity, she explained, noting that in preclinical models, CB‐839 increased intra‐tumoral glutamine and enhanced antitumor activity of PD‐1/PD‐L1 inhibitors.
In the phase 1 dose escalation study, she and her colleagues evaluated the safety and efficacy of CB-839 in combination with the PD‐1 inhibitor nivolumab in patients with melanoma, non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC). Phase 2 expansion cohorts include a melanoma rescue cohort of patients progressing on anti-PD-L1 therapy at study entry (22 patients), an NSCLC and RCC rescue cohort of patients who were progressing on anti-PD-L1 therapy at study entry or who had stable disease for 6 months or longer without a response (11 NSCLC and 11 RCC), an RCC cohort of patients with prior immunotherapy exposure and no response (10 patients), and an RCC cohort of patents who had no prior immunotherapy exposure (28 patients).
During dose escalation, patients received oral CB‐839 at 600 mg or 800 mg twice daily in combination with standard‐dose nivolumab. In the ongoing phase 2 expansion study, which continues to enroll, patients are receiving 800 mg of CB-839 twice daily with standard‐dose nivolumab, Dr. Meric-Bernstam said.
Patients in each of the cohorts were high risk and/or had intermediate or poor prognostic status at study entry. For example, 50% of patients in the melanoma rescue cohort had liver metastases, 77% had other visceral metastases, and 18% had brain metastases, and the majority of patients in the lung cancer/RCC cohort had visceral metastases. Most had progressive disease as their best response on their last line of immunotherapy.
Of 16 response-evaluable melanoma patients, 1 experienced a complete response, 2 had partial responses, and 4 had stable disease.
“So overall in this patient population that was progressing on a PD-1/PD-L1 inhibitor at enrollment, 19% had an objective response. The disease control rate in this group was 44%,” she said.
In evaluable patients in the lung cancer rescue cohort (6 patients), RCC rescue cohort (8 patients), and RCC prior exposure cohort (7 patients), disease control rates ranged from 57% to 75%, and in the immunotherapy-naive RCC cohort (19 patients), the partial response rate was 21%, and 53% had stable disease, so the overall disease control rate was 74%. Half of the patients in that group remain on study, she noted.
A closer look at the melanoma rescue cohort showed dramatic and rapid responses in two patients who each achieved a partial response in about 8 weeks with response durations of 3.7 months and 5.4 months, respectively. Additionally, pre-treatment biopsies in this cohort showed an elevated T-cell inflamed signature associated with clinical benefit from the addition of CB-839, and in one patient who had both a pretreatment and on-treatment biopsy that was evaluable, the latter showed an increase in T-cell inflamed signature and T-cell effector genes.
In all cohorts, the combination therapy was generally well tolerated. A maximum tolerated dose was not reached. Dose-limiting toxicity – a grade 3 alanine aminotransferase (ALT) increase – occurred in one patient on the 800-mg dose. The most common grade 3 or greater adverse events were fatigue, nausea, photophobia, rash, and elevated ALT, she said, noting that two patients discontinued for treatment-related adverse events (one for a grade 3 rash and one for grade 2 pneumonitis).
“Overall there appeared to be no apparent increase in immune-related adverse events, either in rate or severity, compared with [nivolumab] monotherapy,” she said.
The combination of CB-839 and nivolumab was well tolerated, and in some patients – as seen in the melanoma cohort – adding CB-839 to checkpoint blockade can overcome checkpoint blockade resistance, Dr. Meric-Bernstam concluded, noting that the disease control rates seen in the majority of lung cancer and RCC patients who were progressing on checkpoint blockade is encouraging, as is the objective response rate seen thus far in the RCC therapy-naive patients, and the stable and deep responses seen in the melanoma rescue cohort.
“Based on our encouraging signal in the melanoma rescue cohort, this [cohort] has been expanded,” she said.
Calithera Biosciences sponsored the study. Bristol-Myers Squibb provided nivolumab for the study. Dr. Meric-Bernstam has received grant or research support from Calithera Biosciences and many other companies. She also reported being a paid consultant for several companies and serving on an advisory committee or review panel, or as a board member for multiple companies.
NATIONAL HARBOR, MD. – Combination treatment with the first-in-class glutaminase inhibitor CB-839 and nivolumab is well-tolerated and shows clinical activity in patients with advanced melanoma, renal cell carcinoma, or non-small cell lung cancer, including anti-PD-1/PD-L1 refractory patients, according to initial results from a phase 1/2 study.
Responses in melanoma patients who were progressing on nivolumab at study entry and who were refractory to multiple prior immunotherapy regimens are particularly notable, as they highlight the potential for CB-839, when added to nivolumab (Opdivo), to help overcome resistance to anti-PD-L1 therapy, Funda Meric‐Bernstam, MD, reported at the annual meeting of the Society for Immunotherapy of Cancer.
CB‐839 is highly selective and targets tumor glutamine metabolism, said Dr. Meric-Bernstam of the University of Texas MD Anderson Cancer Center, Houston.
Competition between tumor cells and immune cells for nutrients such as glutamine in the tumor microenvironment can create a metabolic checkpoint that induces local immune suppression. CB‐839 inhibits tumor glutamine consumption, thereby increasing glutamine availability to support T‐cell activity, she explained, noting that in preclinical models, CB‐839 increased intra‐tumoral glutamine and enhanced antitumor activity of PD‐1/PD‐L1 inhibitors.
In the phase 1 dose escalation study, she and her colleagues evaluated the safety and efficacy of CB-839 in combination with the PD‐1 inhibitor nivolumab in patients with melanoma, non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC). Phase 2 expansion cohorts include a melanoma rescue cohort of patients progressing on anti-PD-L1 therapy at study entry (22 patients), an NSCLC and RCC rescue cohort of patients who were progressing on anti-PD-L1 therapy at study entry or who had stable disease for 6 months or longer without a response (11 NSCLC and 11 RCC), an RCC cohort of patients with prior immunotherapy exposure and no response (10 patients), and an RCC cohort of patents who had no prior immunotherapy exposure (28 patients).
During dose escalation, patients received oral CB‐839 at 600 mg or 800 mg twice daily in combination with standard‐dose nivolumab. In the ongoing phase 2 expansion study, which continues to enroll, patients are receiving 800 mg of CB-839 twice daily with standard‐dose nivolumab, Dr. Meric-Bernstam said.
Patients in each of the cohorts were high risk and/or had intermediate or poor prognostic status at study entry. For example, 50% of patients in the melanoma rescue cohort had liver metastases, 77% had other visceral metastases, and 18% had brain metastases, and the majority of patients in the lung cancer/RCC cohort had visceral metastases. Most had progressive disease as their best response on their last line of immunotherapy.
Of 16 response-evaluable melanoma patients, 1 experienced a complete response, 2 had partial responses, and 4 had stable disease.
“So overall in this patient population that was progressing on a PD-1/PD-L1 inhibitor at enrollment, 19% had an objective response. The disease control rate in this group was 44%,” she said.
In evaluable patients in the lung cancer rescue cohort (6 patients), RCC rescue cohort (8 patients), and RCC prior exposure cohort (7 patients), disease control rates ranged from 57% to 75%, and in the immunotherapy-naive RCC cohort (19 patients), the partial response rate was 21%, and 53% had stable disease, so the overall disease control rate was 74%. Half of the patients in that group remain on study, she noted.
A closer look at the melanoma rescue cohort showed dramatic and rapid responses in two patients who each achieved a partial response in about 8 weeks with response durations of 3.7 months and 5.4 months, respectively. Additionally, pre-treatment biopsies in this cohort showed an elevated T-cell inflamed signature associated with clinical benefit from the addition of CB-839, and in one patient who had both a pretreatment and on-treatment biopsy that was evaluable, the latter showed an increase in T-cell inflamed signature and T-cell effector genes.
In all cohorts, the combination therapy was generally well tolerated. A maximum tolerated dose was not reached. Dose-limiting toxicity – a grade 3 alanine aminotransferase (ALT) increase – occurred in one patient on the 800-mg dose. The most common grade 3 or greater adverse events were fatigue, nausea, photophobia, rash, and elevated ALT, she said, noting that two patients discontinued for treatment-related adverse events (one for a grade 3 rash and one for grade 2 pneumonitis).
“Overall there appeared to be no apparent increase in immune-related adverse events, either in rate or severity, compared with [nivolumab] monotherapy,” she said.
The combination of CB-839 and nivolumab was well tolerated, and in some patients – as seen in the melanoma cohort – adding CB-839 to checkpoint blockade can overcome checkpoint blockade resistance, Dr. Meric-Bernstam concluded, noting that the disease control rates seen in the majority of lung cancer and RCC patients who were progressing on checkpoint blockade is encouraging, as is the objective response rate seen thus far in the RCC therapy-naive patients, and the stable and deep responses seen in the melanoma rescue cohort.
“Based on our encouraging signal in the melanoma rescue cohort, this [cohort] has been expanded,” she said.
Calithera Biosciences sponsored the study. Bristol-Myers Squibb provided nivolumab for the study. Dr. Meric-Bernstam has received grant or research support from Calithera Biosciences and many other companies. She also reported being a paid consultant for several companies and serving on an advisory committee or review panel, or as a board member for multiple companies.
NATIONAL HARBOR, MD. – Combination treatment with the first-in-class glutaminase inhibitor CB-839 and nivolumab is well-tolerated and shows clinical activity in patients with advanced melanoma, renal cell carcinoma, or non-small cell lung cancer, including anti-PD-1/PD-L1 refractory patients, according to initial results from a phase 1/2 study.
Responses in melanoma patients who were progressing on nivolumab at study entry and who were refractory to multiple prior immunotherapy regimens are particularly notable, as they highlight the potential for CB-839, when added to nivolumab (Opdivo), to help overcome resistance to anti-PD-L1 therapy, Funda Meric‐Bernstam, MD, reported at the annual meeting of the Society for Immunotherapy of Cancer.
CB‐839 is highly selective and targets tumor glutamine metabolism, said Dr. Meric-Bernstam of the University of Texas MD Anderson Cancer Center, Houston.
Competition between tumor cells and immune cells for nutrients such as glutamine in the tumor microenvironment can create a metabolic checkpoint that induces local immune suppression. CB‐839 inhibits tumor glutamine consumption, thereby increasing glutamine availability to support T‐cell activity, she explained, noting that in preclinical models, CB‐839 increased intra‐tumoral glutamine and enhanced antitumor activity of PD‐1/PD‐L1 inhibitors.
In the phase 1 dose escalation study, she and her colleagues evaluated the safety and efficacy of CB-839 in combination with the PD‐1 inhibitor nivolumab in patients with melanoma, non-small cell lung cancer (NSCLC), or renal cell carcinoma (RCC). Phase 2 expansion cohorts include a melanoma rescue cohort of patients progressing on anti-PD-L1 therapy at study entry (22 patients), an NSCLC and RCC rescue cohort of patients who were progressing on anti-PD-L1 therapy at study entry or who had stable disease for 6 months or longer without a response (11 NSCLC and 11 RCC), an RCC cohort of patients with prior immunotherapy exposure and no response (10 patients), and an RCC cohort of patents who had no prior immunotherapy exposure (28 patients).
During dose escalation, patients received oral CB‐839 at 600 mg or 800 mg twice daily in combination with standard‐dose nivolumab. In the ongoing phase 2 expansion study, which continues to enroll, patients are receiving 800 mg of CB-839 twice daily with standard‐dose nivolumab, Dr. Meric-Bernstam said.
Patients in each of the cohorts were high risk and/or had intermediate or poor prognostic status at study entry. For example, 50% of patients in the melanoma rescue cohort had liver metastases, 77% had other visceral metastases, and 18% had brain metastases, and the majority of patients in the lung cancer/RCC cohort had visceral metastases. Most had progressive disease as their best response on their last line of immunotherapy.
Of 16 response-evaluable melanoma patients, 1 experienced a complete response, 2 had partial responses, and 4 had stable disease.
“So overall in this patient population that was progressing on a PD-1/PD-L1 inhibitor at enrollment, 19% had an objective response. The disease control rate in this group was 44%,” she said.
In evaluable patients in the lung cancer rescue cohort (6 patients), RCC rescue cohort (8 patients), and RCC prior exposure cohort (7 patients), disease control rates ranged from 57% to 75%, and in the immunotherapy-naive RCC cohort (19 patients), the partial response rate was 21%, and 53% had stable disease, so the overall disease control rate was 74%. Half of the patients in that group remain on study, she noted.
A closer look at the melanoma rescue cohort showed dramatic and rapid responses in two patients who each achieved a partial response in about 8 weeks with response durations of 3.7 months and 5.4 months, respectively. Additionally, pre-treatment biopsies in this cohort showed an elevated T-cell inflamed signature associated with clinical benefit from the addition of CB-839, and in one patient who had both a pretreatment and on-treatment biopsy that was evaluable, the latter showed an increase in T-cell inflamed signature and T-cell effector genes.
In all cohorts, the combination therapy was generally well tolerated. A maximum tolerated dose was not reached. Dose-limiting toxicity – a grade 3 alanine aminotransferase (ALT) increase – occurred in one patient on the 800-mg dose. The most common grade 3 or greater adverse events were fatigue, nausea, photophobia, rash, and elevated ALT, she said, noting that two patients discontinued for treatment-related adverse events (one for a grade 3 rash and one for grade 2 pneumonitis).
“Overall there appeared to be no apparent increase in immune-related adverse events, either in rate or severity, compared with [nivolumab] monotherapy,” she said.
The combination of CB-839 and nivolumab was well tolerated, and in some patients – as seen in the melanoma cohort – adding CB-839 to checkpoint blockade can overcome checkpoint blockade resistance, Dr. Meric-Bernstam concluded, noting that the disease control rates seen in the majority of lung cancer and RCC patients who were progressing on checkpoint blockade is encouraging, as is the objective response rate seen thus far in the RCC therapy-naive patients, and the stable and deep responses seen in the melanoma rescue cohort.
“Based on our encouraging signal in the melanoma rescue cohort, this [cohort] has been expanded,” she said.
Calithera Biosciences sponsored the study. Bristol-Myers Squibb provided nivolumab for the study. Dr. Meric-Bernstam has received grant or research support from Calithera Biosciences and many other companies. She also reported being a paid consultant for several companies and serving on an advisory committee or review panel, or as a board member for multiple companies.
AT SITC 2017
Key clinical point:
Major finding: The objective response rate in advanced melanoma patients refractory to anti-PD-1/PD-L1 therapy was 19%.
Data source: A phase 1/2 study of 82 patients.
Disclosures: Calithera Biosciences sponsored the study. Bristol-Myers Squibb provided nivolumab for the study. Dr. Meric-Bernstam has received grant or research support from Calithera Biosciences and many other companies. She also reported being a paid consultant for several companies and serving on an advisory committee or review panel or as a board member for multiple companies.
CMS looking to evolve QPP to measure outcomes, not processes
WASHINGTON – The Quality Payment Program, the value-based payment scheme created under the Medicare Access and CHIP Reauthorization Act, will focus on measuring clinical outcomes – instead of processes – if Seema Verma, administrator of the Centers for Medicare & Medicaid Services, has her way.
“I think the concept of paying for value is a good concept,” Ms. Verma told attendees at the annual meeting of the federal Office of the National Coordinator for Health Information Technology on Dec. 1. “A lot of the measures in terms of how we are evaluating providers aren’t necessarily around outcomes. There are a lot of process measures.”
“Many of us have used the health care system and can attest that it is also a lot of times confusing,” she said. “We don’t know where to go for our care. Who is the best doctor? We don’t always have the information about cost or quality or value, and it is difficult to navigate the health care system.”
She said she wants to “make sure that the data that we have at CMS is available to our beneficiaries, whether it be information about their claims data, information about quality, information about the health plan that they may pick, information about their provider directory, information about the quality ratings if they are seeking hospice care.”
Getting to that point will require addressing an ongoing and familiar problem for physicians: interoperability of health care IT systems.
Improved interoperability would allow for greater patient empowerment by providing patients with better access to their own medical data, she said, noting that the data also belongs to the patient.
“That is our information and the patient should have that,” Ms. Verma said. “When we talk about patient empowerment and patients first, this is what we are talking about. This is what I mean. I want to make sure the beneficiaries who are using the Medicaid program, the Medicare program have this information. That is important.”
She also noted that improved interoperability will allow for greater use of data across the health care spectrum, including in the area of drug pricing.
“We have some very high-cost new drugs coming,” she noted. “We are having discussions about how to pay for these drugs in a different way. Maybe we are going [toward] value-based pricing or indication-based pricing [and] so paying for the drug based on the outcomes.”
WASHINGTON – The Quality Payment Program, the value-based payment scheme created under the Medicare Access and CHIP Reauthorization Act, will focus on measuring clinical outcomes – instead of processes – if Seema Verma, administrator of the Centers for Medicare & Medicaid Services, has her way.
“I think the concept of paying for value is a good concept,” Ms. Verma told attendees at the annual meeting of the federal Office of the National Coordinator for Health Information Technology on Dec. 1. “A lot of the measures in terms of how we are evaluating providers aren’t necessarily around outcomes. There are a lot of process measures.”
“Many of us have used the health care system and can attest that it is also a lot of times confusing,” she said. “We don’t know where to go for our care. Who is the best doctor? We don’t always have the information about cost or quality or value, and it is difficult to navigate the health care system.”
She said she wants to “make sure that the data that we have at CMS is available to our beneficiaries, whether it be information about their claims data, information about quality, information about the health plan that they may pick, information about their provider directory, information about the quality ratings if they are seeking hospice care.”
Getting to that point will require addressing an ongoing and familiar problem for physicians: interoperability of health care IT systems.
Improved interoperability would allow for greater patient empowerment by providing patients with better access to their own medical data, she said, noting that the data also belongs to the patient.
“That is our information and the patient should have that,” Ms. Verma said. “When we talk about patient empowerment and patients first, this is what we are talking about. This is what I mean. I want to make sure the beneficiaries who are using the Medicaid program, the Medicare program have this information. That is important.”
She also noted that improved interoperability will allow for greater use of data across the health care spectrum, including in the area of drug pricing.
“We have some very high-cost new drugs coming,” she noted. “We are having discussions about how to pay for these drugs in a different way. Maybe we are going [toward] value-based pricing or indication-based pricing [and] so paying for the drug based on the outcomes.”
WASHINGTON – The Quality Payment Program, the value-based payment scheme created under the Medicare Access and CHIP Reauthorization Act, will focus on measuring clinical outcomes – instead of processes – if Seema Verma, administrator of the Centers for Medicare & Medicaid Services, has her way.
“I think the concept of paying for value is a good concept,” Ms. Verma told attendees at the annual meeting of the federal Office of the National Coordinator for Health Information Technology on Dec. 1. “A lot of the measures in terms of how we are evaluating providers aren’t necessarily around outcomes. There are a lot of process measures.”
“Many of us have used the health care system and can attest that it is also a lot of times confusing,” she said. “We don’t know where to go for our care. Who is the best doctor? We don’t always have the information about cost or quality or value, and it is difficult to navigate the health care system.”
She said she wants to “make sure that the data that we have at CMS is available to our beneficiaries, whether it be information about their claims data, information about quality, information about the health plan that they may pick, information about their provider directory, information about the quality ratings if they are seeking hospice care.”
Getting to that point will require addressing an ongoing and familiar problem for physicians: interoperability of health care IT systems.
Improved interoperability would allow for greater patient empowerment by providing patients with better access to their own medical data, she said, noting that the data also belongs to the patient.
“That is our information and the patient should have that,” Ms. Verma said. “When we talk about patient empowerment and patients first, this is what we are talking about. This is what I mean. I want to make sure the beneficiaries who are using the Medicaid program, the Medicare program have this information. That is important.”
She also noted that improved interoperability will allow for greater use of data across the health care spectrum, including in the area of drug pricing.
“We have some very high-cost new drugs coming,” she noted. “We are having discussions about how to pay for these drugs in a different way. Maybe we are going [toward] value-based pricing or indication-based pricing [and] so paying for the drug based on the outcomes.”
AT ONC 2017
ENCORE 601 study: Entinostat shows promise in NSCLC
NATIONAL HARBOR, MD. – The oral, class I selective histone deacetylase (HDAC) inhibitor entinostat given in combination with pembrolizumab demonstrated antitumor activity and acceptable safety in patients with non–small cell lung cancer in the phase 1b/2 ENCORE 601 study.
Entinostat, which has been shown in preclinical models to enhance suppressor cells in the tumor microenvironment, was evaluated in ENCORE 601 as a treatment for non–small cell lung cancer (NSCLC), melanoma, and colorectal cancer. Previously reported phase 1 results showed that an oral dose of 5 mg weekly plus 200 mg of pembrolizumab given intravenously every 3 weeks deserved further exploration for these indications, according to Leena Gandhi, MD, who reported phase 2, stage 1 results from the lung cancer arm of the Simon two-stage study at the annual meeting of the Society for Immunotherapy of Cancer.
Treatment at that dose was studied in both anti-PD-L1–naive patients with advanced NSCLC, and in NSCLC patients who progressed on anti-PD-L1 treatment, said Dr. Gandhi of New York University Langone Medical Center.
The primary objective of stage 1 was objective response rate, and criteria for advancement were 4 or more responses out of 17 evaluable anti-PD-L1–naive patients (cohort 1), and at least 3 responses out of 31 patients who progressed on anti-PD-L1 therapy (cohort 2).
Both cohorts met the endpoint, with 4 of 17 evaluable cohort 1 patients (24%) achieving a partial response, and 3 of 31 evaluable cohort 2 patients (10%) achieving a partial response.
In cohort 1, two responses were confirmed and two were unconfirmed. One of the unconfirmed patients had malignant pericardial effusion, but remains on study with continued clinical benefit, Dr. Gandhi said, noting that three patients remain on study in all.
“The other notable thing I’d like to point out here … is that the majority of these were patients who did not have high levels of expression of PD-L1,” she said.
In cohort 2 patients, two responses were confirmed and one was unconfirmed. Three patients remain on study.
“In both of these cohorts there are a couple of patients who’ve had quite durable responses,” she said.
The best response to prior anti-PD-1therapy in the cohort 2 patients who had a response was stable disease (two patients). The response to prior therapy was unknown in one patient, she noted.
“All of them had clear regressions, after that initial PD-1 therapy, with this combination,” she said, noting that two had “essentially negative PD-L1 expression, and none had high levels of expression.”
Treatment was associated with grade 3/4 adverse events deemed drug related in 31% of patients; the most common of these events, occurring in at least 10% of patients in cohort 1, were hypophosphatemia and neutropenia, and in cohort 2 were fatigue, anemia, anorexia, and pneumonitis; 13% of patients discontinued treatment due to an adverse event, Dr. Gandhi said.
Of note, there were reductions in circulating myeloid derived suppressor cells in both cohorts following treatment.
Based on the responses seen in this first stage of the study, cohort 2 has advanced to stage 2 and has completed enrollment. Additional patients have not been enrolled in cohort 1, but that is still under consideration, she said.
Dr. Gandhi reported having no disclosures.
NATIONAL HARBOR, MD. – The oral, class I selective histone deacetylase (HDAC) inhibitor entinostat given in combination with pembrolizumab demonstrated antitumor activity and acceptable safety in patients with non–small cell lung cancer in the phase 1b/2 ENCORE 601 study.
Entinostat, which has been shown in preclinical models to enhance suppressor cells in the tumor microenvironment, was evaluated in ENCORE 601 as a treatment for non–small cell lung cancer (NSCLC), melanoma, and colorectal cancer. Previously reported phase 1 results showed that an oral dose of 5 mg weekly plus 200 mg of pembrolizumab given intravenously every 3 weeks deserved further exploration for these indications, according to Leena Gandhi, MD, who reported phase 2, stage 1 results from the lung cancer arm of the Simon two-stage study at the annual meeting of the Society for Immunotherapy of Cancer.
Treatment at that dose was studied in both anti-PD-L1–naive patients with advanced NSCLC, and in NSCLC patients who progressed on anti-PD-L1 treatment, said Dr. Gandhi of New York University Langone Medical Center.
The primary objective of stage 1 was objective response rate, and criteria for advancement were 4 or more responses out of 17 evaluable anti-PD-L1–naive patients (cohort 1), and at least 3 responses out of 31 patients who progressed on anti-PD-L1 therapy (cohort 2).
Both cohorts met the endpoint, with 4 of 17 evaluable cohort 1 patients (24%) achieving a partial response, and 3 of 31 evaluable cohort 2 patients (10%) achieving a partial response.
In cohort 1, two responses were confirmed and two were unconfirmed. One of the unconfirmed patients had malignant pericardial effusion, but remains on study with continued clinical benefit, Dr. Gandhi said, noting that three patients remain on study in all.
“The other notable thing I’d like to point out here … is that the majority of these were patients who did not have high levels of expression of PD-L1,” she said.
In cohort 2 patients, two responses were confirmed and one was unconfirmed. Three patients remain on study.
“In both of these cohorts there are a couple of patients who’ve had quite durable responses,” she said.
The best response to prior anti-PD-1therapy in the cohort 2 patients who had a response was stable disease (two patients). The response to prior therapy was unknown in one patient, she noted.
“All of them had clear regressions, after that initial PD-1 therapy, with this combination,” she said, noting that two had “essentially negative PD-L1 expression, and none had high levels of expression.”
Treatment was associated with grade 3/4 adverse events deemed drug related in 31% of patients; the most common of these events, occurring in at least 10% of patients in cohort 1, were hypophosphatemia and neutropenia, and in cohort 2 were fatigue, anemia, anorexia, and pneumonitis; 13% of patients discontinued treatment due to an adverse event, Dr. Gandhi said.
Of note, there were reductions in circulating myeloid derived suppressor cells in both cohorts following treatment.
Based on the responses seen in this first stage of the study, cohort 2 has advanced to stage 2 and has completed enrollment. Additional patients have not been enrolled in cohort 1, but that is still under consideration, she said.
Dr. Gandhi reported having no disclosures.
NATIONAL HARBOR, MD. – The oral, class I selective histone deacetylase (HDAC) inhibitor entinostat given in combination with pembrolizumab demonstrated antitumor activity and acceptable safety in patients with non–small cell lung cancer in the phase 1b/2 ENCORE 601 study.
Entinostat, which has been shown in preclinical models to enhance suppressor cells in the tumor microenvironment, was evaluated in ENCORE 601 as a treatment for non–small cell lung cancer (NSCLC), melanoma, and colorectal cancer. Previously reported phase 1 results showed that an oral dose of 5 mg weekly plus 200 mg of pembrolizumab given intravenously every 3 weeks deserved further exploration for these indications, according to Leena Gandhi, MD, who reported phase 2, stage 1 results from the lung cancer arm of the Simon two-stage study at the annual meeting of the Society for Immunotherapy of Cancer.
Treatment at that dose was studied in both anti-PD-L1–naive patients with advanced NSCLC, and in NSCLC patients who progressed on anti-PD-L1 treatment, said Dr. Gandhi of New York University Langone Medical Center.
The primary objective of stage 1 was objective response rate, and criteria for advancement were 4 or more responses out of 17 evaluable anti-PD-L1–naive patients (cohort 1), and at least 3 responses out of 31 patients who progressed on anti-PD-L1 therapy (cohort 2).
Both cohorts met the endpoint, with 4 of 17 evaluable cohort 1 patients (24%) achieving a partial response, and 3 of 31 evaluable cohort 2 patients (10%) achieving a partial response.
In cohort 1, two responses were confirmed and two were unconfirmed. One of the unconfirmed patients had malignant pericardial effusion, but remains on study with continued clinical benefit, Dr. Gandhi said, noting that three patients remain on study in all.
“The other notable thing I’d like to point out here … is that the majority of these were patients who did not have high levels of expression of PD-L1,” she said.
In cohort 2 patients, two responses were confirmed and one was unconfirmed. Three patients remain on study.
“In both of these cohorts there are a couple of patients who’ve had quite durable responses,” she said.
The best response to prior anti-PD-1therapy in the cohort 2 patients who had a response was stable disease (two patients). The response to prior therapy was unknown in one patient, she noted.
“All of them had clear regressions, after that initial PD-1 therapy, with this combination,” she said, noting that two had “essentially negative PD-L1 expression, and none had high levels of expression.”
Treatment was associated with grade 3/4 adverse events deemed drug related in 31% of patients; the most common of these events, occurring in at least 10% of patients in cohort 1, were hypophosphatemia and neutropenia, and in cohort 2 were fatigue, anemia, anorexia, and pneumonitis; 13% of patients discontinued treatment due to an adverse event, Dr. Gandhi said.
Of note, there were reductions in circulating myeloid derived suppressor cells in both cohorts following treatment.
Based on the responses seen in this first stage of the study, cohort 2 has advanced to stage 2 and has completed enrollment. Additional patients have not been enrolled in cohort 1, but that is still under consideration, she said.
Dr. Gandhi reported having no disclosures.
AT SITC 2017
Key clinical point:
Major finding: Partial responses were seen in 24% of cohort 1 patients and 10% of cohort 2 patients.
Data source: Stage 1 of a phase 2 Simon two-stage study (48 evaluable patients).
Disclosures: Dr. Gandhi reported having no disclosures.
5 big ways the tax bill could affect health policy
Having failed to repeal and replace the Affordable Care Act, Congress is now working on a tax overhaul. But it turns out the tax bills in the House and Senate also aim to reshape health care.
Here are five big ways the tax bill could affect health policy:
1. Repeal the requirement for most people to have health insurance or pay a tax penalty
Republicans tried and failed to end the so-called individual mandate this year when they attempted to advance their health overhaul legislation. Now the idea is back, at least in the Senate’s version of the tax bill. The measure would not technically remove the requirement for people to have insurance, but it would eliminate the fine people would face if they choose to remain uninsured.
The Congressional Budget Office has estimated that dropping the requirement would result in 13 million fewer people having insurance over 10 years.
It also estimates that premiums would rise 10% more per year than they would without this change. That is because healthier people would be most likely to drop insurance in the absence of a fine, so insurers would have to raise premiums to compensate for a sicker group of customers. Those consumers, in turn, would be left with fewer affordable choices, according to the CBO.
State insurance officials are concerned that insurers will drop out of the individual market entirely if there is no requirement for healthy people to sign up, but they still have to sell to people who know they will need medical care.
Ironically, the states most likely to see this kind of insurance-market disruption are those that are reliably Republican. An analysis by the Los Angeles Times suggested that the states with the fewest insurers and the highest premiums – including Alaska, Iowa, Missouri, Nebraska, Nevada, and Wyoming – would be the ones left with either no coverage options or options too expensive for most consumers in the individual market.
2. Repeal the medical expense deduction
The House-passed tax bill, although not the Senate’s, would eliminate taxpayers’ ability to deduct medical expenses that exceed 10% of their adjusted gross income.
The medical expense deduction is not widely used – just under 9 million tax filers took it on their 2015 tax returns, according to the Internal Revenue Service. But those who do use it generally have very high medical expenses, often for a disabled child, a serious chronic illness, or expensive long-term care not covered by health insurance.
Among those most vehemently against getting rid of the deduction is the senior advocacy group AARP. Eliminating the deduction, the group said in a statement, “amounts to a health tax on millions of Americans with high medical costs – especially middle income seniors.”
3. Trigger major cuts to the Medicare program
The tax bill includes no specific Medicare changes, but budget analysts point out that passing it in its current form would trigger another law to kick in. That measure requires cuts to federal programs if the federal budget deficit is increased.
Because the tax bills in both the House and Senate would add an additional $1.5 trillion to the deficit over the next 10 years, both would result in automatic cuts under the Statutory Pay-As-You-Go Act of 2010 (PAYGO). According to the CBO, if Congress passes the tax bill and does not waive the PAYGO law, federal officials “would be required to issue a sequestration order within 15 days of the end of the session of Congress to reduce spending in fiscal year 2018 by the resultant total of $136 billion.”
Cuts to Medicare are limited under the PAYGO law, so the Medicare reduction would be limited to 4% of program spending, which is roughly $25 billion of that total. Cuts of a similar size would be required in future years. Most of that would likely come from payments to providers.
4. Change tax treatment for graduate students and those paying back student loans
The House bill, though not the Senate’s, would for the first time require graduate students to pay tax on the value of tuition that universities do not require them to pay.
Currently, graduate students in many fields, including science, often are paid a small stipend for teaching while they pursue advanced degrees. Many are technically charged tuition, but it is “waived” as long as they are working for the university.
The House tax bill would eliminate that waiver and require them to pay taxes on the full value of the tuition they don’t have to pay, which would result in many students with fairly low incomes seeing very large tax bills.
At the same time, the House tax bill would eliminate the deduction for interest paid on student loans. This would disproportionately affect young doctors.
According to the Association of American Medical Colleges, 75% of the medical school class of 2017 graduated with student loan debt, with nearly half owing $200,000 or more.
5. Change or eliminate the tax credit for rare disease drug development
Congress created the so-called Orphan Drug Credit in 1983, as part of a package of incentives intended to entice drugmakers to study and develop drugs to treat rare diseases, defined as those affecting fewer than 200,000 people. With such a small potential market, it does not otherwise make financial sense for the companies to spend the millions of dollars necessary to develop treatments for such ailments.
To date, about 500 drugs have come to market using the incentives, although in some cases drugmakers have manipulated the credit for extra financial gain.
The House tax bill would eliminate the tax credit; the Senate bill would scale it back. Sen. Orrin Hatch (R-Utah), chairman of the tax-writing Finance Committee, is one of the original sponsors of the orphan drug law.
The drug industry has been relatively quiet about the potential loss of the credit, but the National Organization for Rare Disorders called the change “wholly unacceptable” and said it “would directly result in 33% fewer orphan drugs coming to market.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Having failed to repeal and replace the Affordable Care Act, Congress is now working on a tax overhaul. But it turns out the tax bills in the House and Senate also aim to reshape health care.
Here are five big ways the tax bill could affect health policy:
1. Repeal the requirement for most people to have health insurance or pay a tax penalty
Republicans tried and failed to end the so-called individual mandate this year when they attempted to advance their health overhaul legislation. Now the idea is back, at least in the Senate’s version of the tax bill. The measure would not technically remove the requirement for people to have insurance, but it would eliminate the fine people would face if they choose to remain uninsured.
The Congressional Budget Office has estimated that dropping the requirement would result in 13 million fewer people having insurance over 10 years.
It also estimates that premiums would rise 10% more per year than they would without this change. That is because healthier people would be most likely to drop insurance in the absence of a fine, so insurers would have to raise premiums to compensate for a sicker group of customers. Those consumers, in turn, would be left with fewer affordable choices, according to the CBO.
State insurance officials are concerned that insurers will drop out of the individual market entirely if there is no requirement for healthy people to sign up, but they still have to sell to people who know they will need medical care.
Ironically, the states most likely to see this kind of insurance-market disruption are those that are reliably Republican. An analysis by the Los Angeles Times suggested that the states with the fewest insurers and the highest premiums – including Alaska, Iowa, Missouri, Nebraska, Nevada, and Wyoming – would be the ones left with either no coverage options or options too expensive for most consumers in the individual market.
2. Repeal the medical expense deduction
The House-passed tax bill, although not the Senate’s, would eliminate taxpayers’ ability to deduct medical expenses that exceed 10% of their adjusted gross income.
The medical expense deduction is not widely used – just under 9 million tax filers took it on their 2015 tax returns, according to the Internal Revenue Service. But those who do use it generally have very high medical expenses, often for a disabled child, a serious chronic illness, or expensive long-term care not covered by health insurance.
Among those most vehemently against getting rid of the deduction is the senior advocacy group AARP. Eliminating the deduction, the group said in a statement, “amounts to a health tax on millions of Americans with high medical costs – especially middle income seniors.”
3. Trigger major cuts to the Medicare program
The tax bill includes no specific Medicare changes, but budget analysts point out that passing it in its current form would trigger another law to kick in. That measure requires cuts to federal programs if the federal budget deficit is increased.
Because the tax bills in both the House and Senate would add an additional $1.5 trillion to the deficit over the next 10 years, both would result in automatic cuts under the Statutory Pay-As-You-Go Act of 2010 (PAYGO). According to the CBO, if Congress passes the tax bill and does not waive the PAYGO law, federal officials “would be required to issue a sequestration order within 15 days of the end of the session of Congress to reduce spending in fiscal year 2018 by the resultant total of $136 billion.”
Cuts to Medicare are limited under the PAYGO law, so the Medicare reduction would be limited to 4% of program spending, which is roughly $25 billion of that total. Cuts of a similar size would be required in future years. Most of that would likely come from payments to providers.
4. Change tax treatment for graduate students and those paying back student loans
The House bill, though not the Senate’s, would for the first time require graduate students to pay tax on the value of tuition that universities do not require them to pay.
Currently, graduate students in many fields, including science, often are paid a small stipend for teaching while they pursue advanced degrees. Many are technically charged tuition, but it is “waived” as long as they are working for the university.
The House tax bill would eliminate that waiver and require them to pay taxes on the full value of the tuition they don’t have to pay, which would result in many students with fairly low incomes seeing very large tax bills.
At the same time, the House tax bill would eliminate the deduction for interest paid on student loans. This would disproportionately affect young doctors.
According to the Association of American Medical Colleges, 75% of the medical school class of 2017 graduated with student loan debt, with nearly half owing $200,000 or more.
5. Change or eliminate the tax credit for rare disease drug development
Congress created the so-called Orphan Drug Credit in 1983, as part of a package of incentives intended to entice drugmakers to study and develop drugs to treat rare diseases, defined as those affecting fewer than 200,000 people. With such a small potential market, it does not otherwise make financial sense for the companies to spend the millions of dollars necessary to develop treatments for such ailments.
To date, about 500 drugs have come to market using the incentives, although in some cases drugmakers have manipulated the credit for extra financial gain.
The House tax bill would eliminate the tax credit; the Senate bill would scale it back. Sen. Orrin Hatch (R-Utah), chairman of the tax-writing Finance Committee, is one of the original sponsors of the orphan drug law.
The drug industry has been relatively quiet about the potential loss of the credit, but the National Organization for Rare Disorders called the change “wholly unacceptable” and said it “would directly result in 33% fewer orphan drugs coming to market.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Having failed to repeal and replace the Affordable Care Act, Congress is now working on a tax overhaul. But it turns out the tax bills in the House and Senate also aim to reshape health care.
Here are five big ways the tax bill could affect health policy:
1. Repeal the requirement for most people to have health insurance or pay a tax penalty
Republicans tried and failed to end the so-called individual mandate this year when they attempted to advance their health overhaul legislation. Now the idea is back, at least in the Senate’s version of the tax bill. The measure would not technically remove the requirement for people to have insurance, but it would eliminate the fine people would face if they choose to remain uninsured.
The Congressional Budget Office has estimated that dropping the requirement would result in 13 million fewer people having insurance over 10 years.
It also estimates that premiums would rise 10% more per year than they would without this change. That is because healthier people would be most likely to drop insurance in the absence of a fine, so insurers would have to raise premiums to compensate for a sicker group of customers. Those consumers, in turn, would be left with fewer affordable choices, according to the CBO.
State insurance officials are concerned that insurers will drop out of the individual market entirely if there is no requirement for healthy people to sign up, but they still have to sell to people who know they will need medical care.
Ironically, the states most likely to see this kind of insurance-market disruption are those that are reliably Republican. An analysis by the Los Angeles Times suggested that the states with the fewest insurers and the highest premiums – including Alaska, Iowa, Missouri, Nebraska, Nevada, and Wyoming – would be the ones left with either no coverage options or options too expensive for most consumers in the individual market.
2. Repeal the medical expense deduction
The House-passed tax bill, although not the Senate’s, would eliminate taxpayers’ ability to deduct medical expenses that exceed 10% of their adjusted gross income.
The medical expense deduction is not widely used – just under 9 million tax filers took it on their 2015 tax returns, according to the Internal Revenue Service. But those who do use it generally have very high medical expenses, often for a disabled child, a serious chronic illness, or expensive long-term care not covered by health insurance.
Among those most vehemently against getting rid of the deduction is the senior advocacy group AARP. Eliminating the deduction, the group said in a statement, “amounts to a health tax on millions of Americans with high medical costs – especially middle income seniors.”
3. Trigger major cuts to the Medicare program
The tax bill includes no specific Medicare changes, but budget analysts point out that passing it in its current form would trigger another law to kick in. That measure requires cuts to federal programs if the federal budget deficit is increased.
Because the tax bills in both the House and Senate would add an additional $1.5 trillion to the deficit over the next 10 years, both would result in automatic cuts under the Statutory Pay-As-You-Go Act of 2010 (PAYGO). According to the CBO, if Congress passes the tax bill and does not waive the PAYGO law, federal officials “would be required to issue a sequestration order within 15 days of the end of the session of Congress to reduce spending in fiscal year 2018 by the resultant total of $136 billion.”
Cuts to Medicare are limited under the PAYGO law, so the Medicare reduction would be limited to 4% of program spending, which is roughly $25 billion of that total. Cuts of a similar size would be required in future years. Most of that would likely come from payments to providers.
4. Change tax treatment for graduate students and those paying back student loans
The House bill, though not the Senate’s, would for the first time require graduate students to pay tax on the value of tuition that universities do not require them to pay.
Currently, graduate students in many fields, including science, often are paid a small stipend for teaching while they pursue advanced degrees. Many are technically charged tuition, but it is “waived” as long as they are working for the university.
The House tax bill would eliminate that waiver and require them to pay taxes on the full value of the tuition they don’t have to pay, which would result in many students with fairly low incomes seeing very large tax bills.
At the same time, the House tax bill would eliminate the deduction for interest paid on student loans. This would disproportionately affect young doctors.
According to the Association of American Medical Colleges, 75% of the medical school class of 2017 graduated with student loan debt, with nearly half owing $200,000 or more.
5. Change or eliminate the tax credit for rare disease drug development
Congress created the so-called Orphan Drug Credit in 1983, as part of a package of incentives intended to entice drugmakers to study and develop drugs to treat rare diseases, defined as those affecting fewer than 200,000 people. With such a small potential market, it does not otherwise make financial sense for the companies to spend the millions of dollars necessary to develop treatments for such ailments.
To date, about 500 drugs have come to market using the incentives, although in some cases drugmakers have manipulated the credit for extra financial gain.
The House tax bill would eliminate the tax credit; the Senate bill would scale it back. Sen. Orrin Hatch (R-Utah), chairman of the tax-writing Finance Committee, is one of the original sponsors of the orphan drug law.
The drug industry has been relatively quiet about the potential loss of the credit, but the National Organization for Rare Disorders called the change “wholly unacceptable” and said it “would directly result in 33% fewer orphan drugs coming to market.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Drug prices a key focus of Senate HELP examination of Azar nomination
WASHINGTON Escalating drug prices topped the agenda as members of the Senate Health, Education, Labor & Pensions Committee interviewed Alex Azar regarding his nomination as secretary of the Department of Health & Human Services.
Mr. Azar, a former HHS deputy secretary and general counsel during the Bush Administration and a former president of Eli Lilly’s U.S. operations, outlined his priorities to the Senate HELP committee during the Nov. 29 hearing.
Drug prices were the focus of many senators’ questions, and while many contentious questions came from panel Democrats, Sen. Rand Paul (R-Ky.) signaled he was not yet on board with his approval for Mr. Azar’s nomination.
“I think many [Americans] perceive [that drug companies use] their economic might to manipulate the system to maximize profits,” Sen. Paul said. “It’s not like they are selling a cheaper product to more people. They are using government to maximize their profits. Do you acknowledge that, under the current system, Big Pharma uses their economic clout to manipulate the patent system to increase drug prices?”
“There are clearly abuses, Senator, in the system, and that is why one of the steps that I mentioned ... that I believe we have to go after, is the gaming of that,” Mr. Azar responded. He suggested that although Hatch-Waxman rules give innovators a time frame to exclusively sell products “there should be a certain moment” when full generic competition should begin.
Sen. Paul also challenged Mr. Azar on the notion of drug importation.
There has not been a successful path to certify that drugs being imported are “safe and reliable,” Mr. Azar noted.
Sen. Paul countered that “you would have to sit there and say that the European Union has unsafe drugs. It would be unsafe for Americans to buy drugs from the European Union or from Canada or Australia. It’s just frankly not true.”
Sen. Paul told Mr. Azar that if he cannot come up with a way to reimport drugs as a means of addressing the high cost of pharmaceuticals in the United States, “I can’t support you.”
Sen. Paul continued that a lot of people have talked about how they are going to change the system, particularly patent issues that stand in the way of generic competition, and “you’ve got some convincing to make me believe that you are going to represent the American people and not Big Pharma, and I know that’s insulting, and I don’t mean it to be because I am sure you are an honest and upright person. But we all have our doubts because Big Pharma manipulates the system to keep prices high. ... We’ve got to fix it. We can’t tepidly go at it. We have to really fix it, and you need to convince those of us who are skeptical that you will be part of fixing it and won’t be beholden to Big Pharma.”
Regarding his other priorities, Mr. Azar noted that, through his “experience helping to implement [Medicare] Part D and with my extensive knowledge of how insurance, manufacturers, pharmacy, and government programs work together, I believe I can bring the skills and experiences to the table that can help us address these issues, while still encouraging discovery so Americans have access to high-quality care.”
He called for making health care “more affordable, more available, and more tailored to what individuals want and need. … Under the status quo, premiums have been skyrocketing year after year, and choices have been dwindling. We must address these challenges for those who have insurance coverage and for those who have been pushed out or left out of the insurance market by the Affordable Care Act.”
Mr. Azar signaled that he will continue the push toward value-based care and will use the power of Medicare to lead the rest of the health care delivery system to follow suit.
“We can better channel the power of health information technology and leverage what is best in our programs and in the private competitive marketplace to ensure the individual patient is the center of decision making and his or her needs are being met with greater transparency and accountability.”
Regarding the opioid crisis, Mr. Azar said that “we must heed President Trump’s call to action and tackle the scourge of the opioid epidemic that is destroying so many individuals, families, and communities. We need aggressive prevention, education, regulatory, and enforcement efforts to stop overprescribing and overuse of these legal and illegal drugs. And we need compassionate treatment for those suffering from dependence and addiction.”
Mr. Azar also was challenged on women’s health issues, particularly the ability of employers to exclude health insurance coverage of contraception because of religious objections. He noted that there needs to be a balance between the medical needs of the patient and the rights of an organization to follow its conscience.
When queried about making contraception available over the counter, he noted that the regulations regarding OTC conversion are outdated, and he was encouraged that FDA Commissioner Scott Gottlieb, MD, is looking into that.
Mr. Azar also committed during the hearing to working with improving interoperability of electronic health records as well as working with physicians to reduce the associated documentation burden.
He voiced his support of reforming the Affordable Care Act, adding that, “if it remains the law, my goal is to implement a way that leads to affordable insurance, leads to choice of insurance that leads to real access and not a meaningless insurance care, and insurance that has the benefits that people want, not what we say in D.C. for them.”
He also expressed support for the use of block grants to help fund Medicaid.
Mr. Azar’s appearance before the HELP committee was a courtesy as the Senate Finance Committee holds jurisdiction over his nomination. No confirmation hearing had been scheduled at press time.
WASHINGTON Escalating drug prices topped the agenda as members of the Senate Health, Education, Labor & Pensions Committee interviewed Alex Azar regarding his nomination as secretary of the Department of Health & Human Services.
Mr. Azar, a former HHS deputy secretary and general counsel during the Bush Administration and a former president of Eli Lilly’s U.S. operations, outlined his priorities to the Senate HELP committee during the Nov. 29 hearing.
Drug prices were the focus of many senators’ questions, and while many contentious questions came from panel Democrats, Sen. Rand Paul (R-Ky.) signaled he was not yet on board with his approval for Mr. Azar’s nomination.
“I think many [Americans] perceive [that drug companies use] their economic might to manipulate the system to maximize profits,” Sen. Paul said. “It’s not like they are selling a cheaper product to more people. They are using government to maximize their profits. Do you acknowledge that, under the current system, Big Pharma uses their economic clout to manipulate the patent system to increase drug prices?”
“There are clearly abuses, Senator, in the system, and that is why one of the steps that I mentioned ... that I believe we have to go after, is the gaming of that,” Mr. Azar responded. He suggested that although Hatch-Waxman rules give innovators a time frame to exclusively sell products “there should be a certain moment” when full generic competition should begin.
Sen. Paul also challenged Mr. Azar on the notion of drug importation.
There has not been a successful path to certify that drugs being imported are “safe and reliable,” Mr. Azar noted.
Sen. Paul countered that “you would have to sit there and say that the European Union has unsafe drugs. It would be unsafe for Americans to buy drugs from the European Union or from Canada or Australia. It’s just frankly not true.”
Sen. Paul told Mr. Azar that if he cannot come up with a way to reimport drugs as a means of addressing the high cost of pharmaceuticals in the United States, “I can’t support you.”
Sen. Paul continued that a lot of people have talked about how they are going to change the system, particularly patent issues that stand in the way of generic competition, and “you’ve got some convincing to make me believe that you are going to represent the American people and not Big Pharma, and I know that’s insulting, and I don’t mean it to be because I am sure you are an honest and upright person. But we all have our doubts because Big Pharma manipulates the system to keep prices high. ... We’ve got to fix it. We can’t tepidly go at it. We have to really fix it, and you need to convince those of us who are skeptical that you will be part of fixing it and won’t be beholden to Big Pharma.”
Regarding his other priorities, Mr. Azar noted that, through his “experience helping to implement [Medicare] Part D and with my extensive knowledge of how insurance, manufacturers, pharmacy, and government programs work together, I believe I can bring the skills and experiences to the table that can help us address these issues, while still encouraging discovery so Americans have access to high-quality care.”
He called for making health care “more affordable, more available, and more tailored to what individuals want and need. … Under the status quo, premiums have been skyrocketing year after year, and choices have been dwindling. We must address these challenges for those who have insurance coverage and for those who have been pushed out or left out of the insurance market by the Affordable Care Act.”
Mr. Azar signaled that he will continue the push toward value-based care and will use the power of Medicare to lead the rest of the health care delivery system to follow suit.
“We can better channel the power of health information technology and leverage what is best in our programs and in the private competitive marketplace to ensure the individual patient is the center of decision making and his or her needs are being met with greater transparency and accountability.”
Regarding the opioid crisis, Mr. Azar said that “we must heed President Trump’s call to action and tackle the scourge of the opioid epidemic that is destroying so many individuals, families, and communities. We need aggressive prevention, education, regulatory, and enforcement efforts to stop overprescribing and overuse of these legal and illegal drugs. And we need compassionate treatment for those suffering from dependence and addiction.”
Mr. Azar also was challenged on women’s health issues, particularly the ability of employers to exclude health insurance coverage of contraception because of religious objections. He noted that there needs to be a balance between the medical needs of the patient and the rights of an organization to follow its conscience.
When queried about making contraception available over the counter, he noted that the regulations regarding OTC conversion are outdated, and he was encouraged that FDA Commissioner Scott Gottlieb, MD, is looking into that.
Mr. Azar also committed during the hearing to working with improving interoperability of electronic health records as well as working with physicians to reduce the associated documentation burden.
He voiced his support of reforming the Affordable Care Act, adding that, “if it remains the law, my goal is to implement a way that leads to affordable insurance, leads to choice of insurance that leads to real access and not a meaningless insurance care, and insurance that has the benefits that people want, not what we say in D.C. for them.”
He also expressed support for the use of block grants to help fund Medicaid.
Mr. Azar’s appearance before the HELP committee was a courtesy as the Senate Finance Committee holds jurisdiction over his nomination. No confirmation hearing had been scheduled at press time.
WASHINGTON Escalating drug prices topped the agenda as members of the Senate Health, Education, Labor & Pensions Committee interviewed Alex Azar regarding his nomination as secretary of the Department of Health & Human Services.
Mr. Azar, a former HHS deputy secretary and general counsel during the Bush Administration and a former president of Eli Lilly’s U.S. operations, outlined his priorities to the Senate HELP committee during the Nov. 29 hearing.
Drug prices were the focus of many senators’ questions, and while many contentious questions came from panel Democrats, Sen. Rand Paul (R-Ky.) signaled he was not yet on board with his approval for Mr. Azar’s nomination.
“I think many [Americans] perceive [that drug companies use] their economic might to manipulate the system to maximize profits,” Sen. Paul said. “It’s not like they are selling a cheaper product to more people. They are using government to maximize their profits. Do you acknowledge that, under the current system, Big Pharma uses their economic clout to manipulate the patent system to increase drug prices?”
“There are clearly abuses, Senator, in the system, and that is why one of the steps that I mentioned ... that I believe we have to go after, is the gaming of that,” Mr. Azar responded. He suggested that although Hatch-Waxman rules give innovators a time frame to exclusively sell products “there should be a certain moment” when full generic competition should begin.
Sen. Paul also challenged Mr. Azar on the notion of drug importation.
There has not been a successful path to certify that drugs being imported are “safe and reliable,” Mr. Azar noted.
Sen. Paul countered that “you would have to sit there and say that the European Union has unsafe drugs. It would be unsafe for Americans to buy drugs from the European Union or from Canada or Australia. It’s just frankly not true.”
Sen. Paul told Mr. Azar that if he cannot come up with a way to reimport drugs as a means of addressing the high cost of pharmaceuticals in the United States, “I can’t support you.”
Sen. Paul continued that a lot of people have talked about how they are going to change the system, particularly patent issues that stand in the way of generic competition, and “you’ve got some convincing to make me believe that you are going to represent the American people and not Big Pharma, and I know that’s insulting, and I don’t mean it to be because I am sure you are an honest and upright person. But we all have our doubts because Big Pharma manipulates the system to keep prices high. ... We’ve got to fix it. We can’t tepidly go at it. We have to really fix it, and you need to convince those of us who are skeptical that you will be part of fixing it and won’t be beholden to Big Pharma.”
Regarding his other priorities, Mr. Azar noted that, through his “experience helping to implement [Medicare] Part D and with my extensive knowledge of how insurance, manufacturers, pharmacy, and government programs work together, I believe I can bring the skills and experiences to the table that can help us address these issues, while still encouraging discovery so Americans have access to high-quality care.”
He called for making health care “more affordable, more available, and more tailored to what individuals want and need. … Under the status quo, premiums have been skyrocketing year after year, and choices have been dwindling. We must address these challenges for those who have insurance coverage and for those who have been pushed out or left out of the insurance market by the Affordable Care Act.”
Mr. Azar signaled that he will continue the push toward value-based care and will use the power of Medicare to lead the rest of the health care delivery system to follow suit.
“We can better channel the power of health information technology and leverage what is best in our programs and in the private competitive marketplace to ensure the individual patient is the center of decision making and his or her needs are being met with greater transparency and accountability.”
Regarding the opioid crisis, Mr. Azar said that “we must heed President Trump’s call to action and tackle the scourge of the opioid epidemic that is destroying so many individuals, families, and communities. We need aggressive prevention, education, regulatory, and enforcement efforts to stop overprescribing and overuse of these legal and illegal drugs. And we need compassionate treatment for those suffering from dependence and addiction.”
Mr. Azar also was challenged on women’s health issues, particularly the ability of employers to exclude health insurance coverage of contraception because of religious objections. He noted that there needs to be a balance between the medical needs of the patient and the rights of an organization to follow its conscience.
When queried about making contraception available over the counter, he noted that the regulations regarding OTC conversion are outdated, and he was encouraged that FDA Commissioner Scott Gottlieb, MD, is looking into that.
Mr. Azar also committed during the hearing to working with improving interoperability of electronic health records as well as working with physicians to reduce the associated documentation burden.
He voiced his support of reforming the Affordable Care Act, adding that, “if it remains the law, my goal is to implement a way that leads to affordable insurance, leads to choice of insurance that leads to real access and not a meaningless insurance care, and insurance that has the benefits that people want, not what we say in D.C. for them.”
He also expressed support for the use of block grants to help fund Medicaid.
Mr. Azar’s appearance before the HELP committee was a courtesy as the Senate Finance Committee holds jurisdiction over his nomination. No confirmation hearing had been scheduled at press time.
AT A SENATE HELP COMMITTEE HEARING
Defining quality in lung cancer surgery
Implementing quality initiatives and creating reporting mechanisms for lung cancer patients can lead to better outcomes, including overall survival. While barriers exist – namely the conflicting perspectives of providers, payers, hospitals, and patients – thoracic oncologic surgeons should seize the opportunity to establish robust quality and value metrics for lung cancer programs, said Whitney S. Brandt, MD, and her coauthors in an expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154:1397-403).
Dr. Brandt, a surgeon at Memorial Sloan Kettering Cancer Center in New York, and her coauthors examined the key elements of quality and value initiatives, categorizing them into preoperative, intraoperative, and postoperative components and primarily focusing on early stage lung cancer. The National Institutes of Health/National Cancer Center provided a grant for the authors’ work.
The preoperative evaluation should at least include CT imaging of the tumor and, for smokers, smoking cessation, said Dr. Brandt and her coauthors. All candidates for pulmonary lung resection should have spirometry and diffusion capacity tests; furthermore, both predicted postoperative forced expiratory volume in 1 second and diffusing capacity of the lungs for CO should be calculated. “Patients with a predicted postoperative value less than 40% for either measurement should be considered high risk for lobectomy and should be offered either sublobar resection or nonsurgical therapy,” they recommended.
Dr. Brandt and her colleagues also clarified preoperative management of patients with cardiac disease. Only patients with significant cardiac disease risk factors need to undergo cardiac testing before lung surgery, and patients with stable cardiac disease do not require revascularization beforehand.
For preoperative staging, the most comprehensive clinical guidelines come from the National Comprehensive Cancer Network, they stated. The guidelines recommend that all patients with a small cell lung cancer or stage II to IV non–small cell lung cancer (NSCLC) receive a brain MRI or – if that’s not available – a head CT with contrast to assess for brain metastasis.
Intraoperative quality measures take into account the surgical approach, including cost, resection and margins, and lymph node evaluation. With regard to surgical approach, trials have shown traditional video-assisted surgery (VATS) lobectomy results in shorter hospital stays and thereby lower costs, as well as fewer complications and deaths, than thoracotomy, said Dr. Brandt and her coauthors. But that cost advantage has not yet carried over to robotic-assisted VATS. That said, “robotic-assisted VATS remains a relatively new technology, and with time and increased robotic platform competition, costs will likely decrease.”
Dr. Brandt and her coauthors also noted that clinical trials support resection margins of 2 cm in patients having surgery for NSCLC and that adequate lymph node evaluation is a critical component of a lung cancer quality initiative. “Regardless of whether lymph nodes are sampled or dissected, we believe that systematic acquisition of mediastinal nodal tissue based on nodal station(s) is a useful quality metric, and, therefore, we recommend each program adopt a preferred approach and track adherence,” they said.
As for postoperative quality metrics, the most obvious are morbidity and mortality. “A quality program should track 30-day or in-hospital mortality, as well as 90-day mortality, following lung cancer resection.” Such metrics can serve as “starting points” for quality improvement initiatives. Length of stay has also emerged as an important metric because it is a surrogate of other metrics, such as patient comorbidities, age, and socioeconomic status. “Length-of-stay metrics likely need to be risk-stratified on the basis of these and other variables to be meaningful to a practicing surgeon,” Dr. Brandt and her coauthors said, adding that: “Studying the effectiveness of enhanced recovery after surgery programs in thoracic surgical oncology poses an opportunity for a well-designed trial.”
Two other key quality metrics for lung cancer programs that need further development were pointed out in the paper: hospital readmissions and tracking of adjuvant therapies. “Programmatic oncologic quality metrics to track appropriate and inappropriate referrals for adjuvant therapy and the number of patients who complete such therapy are important,” they said.
Another step programs should take: Participating in a national or regional database, as recommended by the Society of Thoracic Surgeons, and taking advantage of the “clear benefits to benchmarking your program to others.”
Dr. Brandt and her coauthors reported having no financial disclosures. The National Institutes of Health/National Cancer Center provided grant support.
Whitney S. Brandt, MD, and her coauthors pointed out the difficulty of finding a comprehensive quality metric because of the multitude of contributing indicators, said Alessandro Brunelli, MD, of St. James University Hospital in Leeds, England, in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:1404-5). But he added that two nonclinical indicators needed further consideration: patient perspectives and costs.
“Satisfaction with care depends on multiple subjective factors and is affected by different socioeconomic and cultural backgrounds,” Dr. Brunelli said. “There have been very few attempts to use patient satisfaction scales as a measure of quality in our specialty.” Residual quality of life after surgery is another key measure of patient perspective. “Long-term survival in fact cannot be assessed in isolation and without taking into consideration the actual quality of life of the cancer survivors,” he said. That information would help inform surgical decision-making.
To be meaningful as a quality metric, cost requires clinical risk adjustment, Dr. Brunelli wrote, and surgeons should take the lead here “to prevent misleading evaluations by third parties.” He added, “There have been few studies reporting on financial risk models in our specialty, and more research is needed in this field.”
Dr. Brunelli reported having no financial disclosures.
Whitney S. Brandt, MD, and her coauthors pointed out the difficulty of finding a comprehensive quality metric because of the multitude of contributing indicators, said Alessandro Brunelli, MD, of St. James University Hospital in Leeds, England, in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:1404-5). But he added that two nonclinical indicators needed further consideration: patient perspectives and costs.
“Satisfaction with care depends on multiple subjective factors and is affected by different socioeconomic and cultural backgrounds,” Dr. Brunelli said. “There have been very few attempts to use patient satisfaction scales as a measure of quality in our specialty.” Residual quality of life after surgery is another key measure of patient perspective. “Long-term survival in fact cannot be assessed in isolation and without taking into consideration the actual quality of life of the cancer survivors,” he said. That information would help inform surgical decision-making.
To be meaningful as a quality metric, cost requires clinical risk adjustment, Dr. Brunelli wrote, and surgeons should take the lead here “to prevent misleading evaluations by third parties.” He added, “There have been few studies reporting on financial risk models in our specialty, and more research is needed in this field.”
Dr. Brunelli reported having no financial disclosures.
Whitney S. Brandt, MD, and her coauthors pointed out the difficulty of finding a comprehensive quality metric because of the multitude of contributing indicators, said Alessandro Brunelli, MD, of St. James University Hospital in Leeds, England, in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:1404-5). But he added that two nonclinical indicators needed further consideration: patient perspectives and costs.
“Satisfaction with care depends on multiple subjective factors and is affected by different socioeconomic and cultural backgrounds,” Dr. Brunelli said. “There have been very few attempts to use patient satisfaction scales as a measure of quality in our specialty.” Residual quality of life after surgery is another key measure of patient perspective. “Long-term survival in fact cannot be assessed in isolation and without taking into consideration the actual quality of life of the cancer survivors,” he said. That information would help inform surgical decision-making.
To be meaningful as a quality metric, cost requires clinical risk adjustment, Dr. Brunelli wrote, and surgeons should take the lead here “to prevent misleading evaluations by third parties.” He added, “There have been few studies reporting on financial risk models in our specialty, and more research is needed in this field.”
Dr. Brunelli reported having no financial disclosures.
Implementing quality initiatives and creating reporting mechanisms for lung cancer patients can lead to better outcomes, including overall survival. While barriers exist – namely the conflicting perspectives of providers, payers, hospitals, and patients – thoracic oncologic surgeons should seize the opportunity to establish robust quality and value metrics for lung cancer programs, said Whitney S. Brandt, MD, and her coauthors in an expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154:1397-403).
Dr. Brandt, a surgeon at Memorial Sloan Kettering Cancer Center in New York, and her coauthors examined the key elements of quality and value initiatives, categorizing them into preoperative, intraoperative, and postoperative components and primarily focusing on early stage lung cancer. The National Institutes of Health/National Cancer Center provided a grant for the authors’ work.
The preoperative evaluation should at least include CT imaging of the tumor and, for smokers, smoking cessation, said Dr. Brandt and her coauthors. All candidates for pulmonary lung resection should have spirometry and diffusion capacity tests; furthermore, both predicted postoperative forced expiratory volume in 1 second and diffusing capacity of the lungs for CO should be calculated. “Patients with a predicted postoperative value less than 40% for either measurement should be considered high risk for lobectomy and should be offered either sublobar resection or nonsurgical therapy,” they recommended.
Dr. Brandt and her colleagues also clarified preoperative management of patients with cardiac disease. Only patients with significant cardiac disease risk factors need to undergo cardiac testing before lung surgery, and patients with stable cardiac disease do not require revascularization beforehand.
For preoperative staging, the most comprehensive clinical guidelines come from the National Comprehensive Cancer Network, they stated. The guidelines recommend that all patients with a small cell lung cancer or stage II to IV non–small cell lung cancer (NSCLC) receive a brain MRI or – if that’s not available – a head CT with contrast to assess for brain metastasis.
Intraoperative quality measures take into account the surgical approach, including cost, resection and margins, and lymph node evaluation. With regard to surgical approach, trials have shown traditional video-assisted surgery (VATS) lobectomy results in shorter hospital stays and thereby lower costs, as well as fewer complications and deaths, than thoracotomy, said Dr. Brandt and her coauthors. But that cost advantage has not yet carried over to robotic-assisted VATS. That said, “robotic-assisted VATS remains a relatively new technology, and with time and increased robotic platform competition, costs will likely decrease.”
Dr. Brandt and her coauthors also noted that clinical trials support resection margins of 2 cm in patients having surgery for NSCLC and that adequate lymph node evaluation is a critical component of a lung cancer quality initiative. “Regardless of whether lymph nodes are sampled or dissected, we believe that systematic acquisition of mediastinal nodal tissue based on nodal station(s) is a useful quality metric, and, therefore, we recommend each program adopt a preferred approach and track adherence,” they said.
As for postoperative quality metrics, the most obvious are morbidity and mortality. “A quality program should track 30-day or in-hospital mortality, as well as 90-day mortality, following lung cancer resection.” Such metrics can serve as “starting points” for quality improvement initiatives. Length of stay has also emerged as an important metric because it is a surrogate of other metrics, such as patient comorbidities, age, and socioeconomic status. “Length-of-stay metrics likely need to be risk-stratified on the basis of these and other variables to be meaningful to a practicing surgeon,” Dr. Brandt and her coauthors said, adding that: “Studying the effectiveness of enhanced recovery after surgery programs in thoracic surgical oncology poses an opportunity for a well-designed trial.”
Two other key quality metrics for lung cancer programs that need further development were pointed out in the paper: hospital readmissions and tracking of adjuvant therapies. “Programmatic oncologic quality metrics to track appropriate and inappropriate referrals for adjuvant therapy and the number of patients who complete such therapy are important,” they said.
Another step programs should take: Participating in a national or regional database, as recommended by the Society of Thoracic Surgeons, and taking advantage of the “clear benefits to benchmarking your program to others.”
Dr. Brandt and her coauthors reported having no financial disclosures. The National Institutes of Health/National Cancer Center provided grant support.
Implementing quality initiatives and creating reporting mechanisms for lung cancer patients can lead to better outcomes, including overall survival. While barriers exist – namely the conflicting perspectives of providers, payers, hospitals, and patients – thoracic oncologic surgeons should seize the opportunity to establish robust quality and value metrics for lung cancer programs, said Whitney S. Brandt, MD, and her coauthors in an expert opinion in the Journal of Thoracic and Cardiovascular Surgery (2017;154:1397-403).
Dr. Brandt, a surgeon at Memorial Sloan Kettering Cancer Center in New York, and her coauthors examined the key elements of quality and value initiatives, categorizing them into preoperative, intraoperative, and postoperative components and primarily focusing on early stage lung cancer. The National Institutes of Health/National Cancer Center provided a grant for the authors’ work.
The preoperative evaluation should at least include CT imaging of the tumor and, for smokers, smoking cessation, said Dr. Brandt and her coauthors. All candidates for pulmonary lung resection should have spirometry and diffusion capacity tests; furthermore, both predicted postoperative forced expiratory volume in 1 second and diffusing capacity of the lungs for CO should be calculated. “Patients with a predicted postoperative value less than 40% for either measurement should be considered high risk for lobectomy and should be offered either sublobar resection or nonsurgical therapy,” they recommended.
Dr. Brandt and her colleagues also clarified preoperative management of patients with cardiac disease. Only patients with significant cardiac disease risk factors need to undergo cardiac testing before lung surgery, and patients with stable cardiac disease do not require revascularization beforehand.
For preoperative staging, the most comprehensive clinical guidelines come from the National Comprehensive Cancer Network, they stated. The guidelines recommend that all patients with a small cell lung cancer or stage II to IV non–small cell lung cancer (NSCLC) receive a brain MRI or – if that’s not available – a head CT with contrast to assess for brain metastasis.
Intraoperative quality measures take into account the surgical approach, including cost, resection and margins, and lymph node evaluation. With regard to surgical approach, trials have shown traditional video-assisted surgery (VATS) lobectomy results in shorter hospital stays and thereby lower costs, as well as fewer complications and deaths, than thoracotomy, said Dr. Brandt and her coauthors. But that cost advantage has not yet carried over to robotic-assisted VATS. That said, “robotic-assisted VATS remains a relatively new technology, and with time and increased robotic platform competition, costs will likely decrease.”
Dr. Brandt and her coauthors also noted that clinical trials support resection margins of 2 cm in patients having surgery for NSCLC and that adequate lymph node evaluation is a critical component of a lung cancer quality initiative. “Regardless of whether lymph nodes are sampled or dissected, we believe that systematic acquisition of mediastinal nodal tissue based on nodal station(s) is a useful quality metric, and, therefore, we recommend each program adopt a preferred approach and track adherence,” they said.
As for postoperative quality metrics, the most obvious are morbidity and mortality. “A quality program should track 30-day or in-hospital mortality, as well as 90-day mortality, following lung cancer resection.” Such metrics can serve as “starting points” for quality improvement initiatives. Length of stay has also emerged as an important metric because it is a surrogate of other metrics, such as patient comorbidities, age, and socioeconomic status. “Length-of-stay metrics likely need to be risk-stratified on the basis of these and other variables to be meaningful to a practicing surgeon,” Dr. Brandt and her coauthors said, adding that: “Studying the effectiveness of enhanced recovery after surgery programs in thoracic surgical oncology poses an opportunity for a well-designed trial.”
Two other key quality metrics for lung cancer programs that need further development were pointed out in the paper: hospital readmissions and tracking of adjuvant therapies. “Programmatic oncologic quality metrics to track appropriate and inappropriate referrals for adjuvant therapy and the number of patients who complete such therapy are important,” they said.
Another step programs should take: Participating in a national or regional database, as recommended by the Society of Thoracic Surgeons, and taking advantage of the “clear benefits to benchmarking your program to others.”
Dr. Brandt and her coauthors reported having no financial disclosures. The National Institutes of Health/National Cancer Center provided grant support.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Quality and value initiatives in lung cancer surgery are complex and multifaceted.
Major finding: Expert opinion identifies quality and value strategies for the preoperative, intraoperative, and postoperative stages.
Data source: Review of elements of quality and value for lung cancer surgery, including the Donabedian classification of structure, process and outcomes.
Disclosures: Dr. Brandt and co-authors reported having no financial disclosures. The National Institutes of Health/National Cancer Center provided grant support.
Bilateral ACP shown similar to unilateral in arch replacement study
What may be the largest study comparing unilateral and bilateral antegrade cerebral perfusion during total arch replacement for type A aortic dissection has reported that outcomes between the two approaches are comparable, although the bilateral approach showed some advantages during the operation itself, investigators from China reported in the Journal of Thoracic and Cardiovascular Surgery (2017;154:767-75).
The effectiveness of bilateral antegrade cerebral perfusion (b-ACP) vs. unilateral antegrade cerebral perfusion (u-ACP) has been the focus of extensive debate, lead study author Guang Tong, MD, of the Guangzhou (China) General Hospital, and coauthors said. They compared outcomes in six different metrics, ranging from cardiopulmonary bypass time to length of stay (LOS) in the ICU and hospital, in 203 patients with type A aortic dissection who had total aortic arch replacement with hypothermic circulatory arrest over an 8-year period ending in August 2014; 121 had b-ACP and 82 had u-ACP. “The issue of u-ACP vs. b-ACP has been examined in aortic arch surgery, but few reports have focused on type A aortic dissection,” Dr. Tong and coauthors wrote.
They acknowledged that some surgeons are reluctant to use b-ACP because of its complexity, but their study found no increase in cross-clamp time, cardiopulmonary bypass time, or surgery time in the b-ACP group. They cited another reason surgeons give for avoiding b-ACP: the risk of embolic injury caused by canulating the left common carotid artery in an atheromatous aorta. “In the present study, this risk was avoided by attaching the left common carotid artery to the four-branched prosthetic graft for left hemisphere perfusion,” Dr. Tong and coauthors wrote.
Key outcomes that the researchers found not statistically significant were:
- Overall 30-day mortality (11.6% for b-ACP vs. 20.7% for u-ACP; P = .075).
- Prevalence of postoperative permanent neurologic dysfunction (8.4% vs. 16.9%; P = .091).
- Average ICU LOS (16 ± 17.75 days vs. 17 ± 11.5 days, P =.454).
- Average hospital LOS (26.5 ± 20.6 days vs. 24.8 ± 10.3 days, P = .434).
However, average ventilation time was lower in the b-ACP group (95.5 hours vs. 147 hours; P less than or equal to.001).
Dr. Tong and coauthors used an aggressive approach, as advocated by Dhaval Trivedi, MD, and colleagues (Ann Thorac Surg. 2016;101:896-903), and had a total arch replacement rate of 57.8%. This rate is higher than most published series in the west but comparable to other studies from China, perhaps because of the relatively young age of this study cohort – an average age of 51 years – compared to data sets other studies have used. Dr. Tong and coauthors used a b-ACP strategy that established both cerebral perfusion routes before circulatory arrest.
Rates of the following complications were also not significantly different across the study population: paraplegia (2.8% for b-ACP vs. 3.1% for u-ACP), temporary neurologic dysfunction (4.7% vs. 9.2%), permanent neurologic dysfunction (8.4% vs. 16.9%), renal failure (18% vs. 23.1%), reoperation for bleeding (2.8% vs. 4.6%), and mediastinal infection (3.7% vs. 6.2%).
While b-ACP patients did not have a statistically significant lower incidence of TND, Dr. Tong and coauthors noted the shorter time on ventilation and significantly lower tracheostomy rates for the b-ACP patients, 3.7% vs. 16.9% for the u-ACP group (P = .003). “In our institute, protocols to wean patients from ventilation were normally initiated as soon as consciousness was regained,” Dr. Tong and coauthors wrote.
Among the study limits Dr. Tong and coauthors acknowledged were its retrospective, nonrandomized, single-center nature, and the fact that the surgeries were performed over an 8-year period representing different eras.
The investigators reported having no relevant financial disclosures.
The study by Dr. Tong and coauthors adds to the discussion between the “bilateralists” and “unilateralists,” as Jean Bachet, MD, called the two prevailing camps on cerebral perfusion strategies in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:765-6). And while most clinical reports find outcomes similar between the two approaches, the evidence favors the bilateral approach for total arch replacement.
Citing how the study implied mortality and neurologic morbidity rates almost half those for unilateral perfusion, but not reaching statistical significance, Dr. Bachet said, “The statisticians would say that this is only a trend and no proof, but some trends might be indicative, and significance might only be a matter of number in each arm of the comparison.”
Dr. Bachet raised a question about the unilateral approach – that once the arch is opened it takes a minute or so to insert the small balloon canula into the origin of the left carotid artery or divided vessel and start bilateral perfusion. “A major question arises,” said Dr. Bachet: “Why should we expose our patients to any undue risk just to avoid a simple maneuver, to spare a little time, or for any other fancy and questionable reason?”
Cardiologists have raised that question for more than 20 years. Said Dr. Bachet, “We still wait for the answer.”
Dr. Bachet is a cardiac surgeon in Surgenes, France. He reported having no financial relationships to disclose.
The study by Dr. Tong and coauthors adds to the discussion between the “bilateralists” and “unilateralists,” as Jean Bachet, MD, called the two prevailing camps on cerebral perfusion strategies in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:765-6). And while most clinical reports find outcomes similar between the two approaches, the evidence favors the bilateral approach for total arch replacement.
Citing how the study implied mortality and neurologic morbidity rates almost half those for unilateral perfusion, but not reaching statistical significance, Dr. Bachet said, “The statisticians would say that this is only a trend and no proof, but some trends might be indicative, and significance might only be a matter of number in each arm of the comparison.”
Dr. Bachet raised a question about the unilateral approach – that once the arch is opened it takes a minute or so to insert the small balloon canula into the origin of the left carotid artery or divided vessel and start bilateral perfusion. “A major question arises,” said Dr. Bachet: “Why should we expose our patients to any undue risk just to avoid a simple maneuver, to spare a little time, or for any other fancy and questionable reason?”
Cardiologists have raised that question for more than 20 years. Said Dr. Bachet, “We still wait for the answer.”
Dr. Bachet is a cardiac surgeon in Surgenes, France. He reported having no financial relationships to disclose.
The study by Dr. Tong and coauthors adds to the discussion between the “bilateralists” and “unilateralists,” as Jean Bachet, MD, called the two prevailing camps on cerebral perfusion strategies in his invited commentary (J Thorac Cardiovasc Surg. 2017;154:765-6). And while most clinical reports find outcomes similar between the two approaches, the evidence favors the bilateral approach for total arch replacement.
Citing how the study implied mortality and neurologic morbidity rates almost half those for unilateral perfusion, but not reaching statistical significance, Dr. Bachet said, “The statisticians would say that this is only a trend and no proof, but some trends might be indicative, and significance might only be a matter of number in each arm of the comparison.”
Dr. Bachet raised a question about the unilateral approach – that once the arch is opened it takes a minute or so to insert the small balloon canula into the origin of the left carotid artery or divided vessel and start bilateral perfusion. “A major question arises,” said Dr. Bachet: “Why should we expose our patients to any undue risk just to avoid a simple maneuver, to spare a little time, or for any other fancy and questionable reason?”
Cardiologists have raised that question for more than 20 years. Said Dr. Bachet, “We still wait for the answer.”
Dr. Bachet is a cardiac surgeon in Surgenes, France. He reported having no financial relationships to disclose.
What may be the largest study comparing unilateral and bilateral antegrade cerebral perfusion during total arch replacement for type A aortic dissection has reported that outcomes between the two approaches are comparable, although the bilateral approach showed some advantages during the operation itself, investigators from China reported in the Journal of Thoracic and Cardiovascular Surgery (2017;154:767-75).
The effectiveness of bilateral antegrade cerebral perfusion (b-ACP) vs. unilateral antegrade cerebral perfusion (u-ACP) has been the focus of extensive debate, lead study author Guang Tong, MD, of the Guangzhou (China) General Hospital, and coauthors said. They compared outcomes in six different metrics, ranging from cardiopulmonary bypass time to length of stay (LOS) in the ICU and hospital, in 203 patients with type A aortic dissection who had total aortic arch replacement with hypothermic circulatory arrest over an 8-year period ending in August 2014; 121 had b-ACP and 82 had u-ACP. “The issue of u-ACP vs. b-ACP has been examined in aortic arch surgery, but few reports have focused on type A aortic dissection,” Dr. Tong and coauthors wrote.
They acknowledged that some surgeons are reluctant to use b-ACP because of its complexity, but their study found no increase in cross-clamp time, cardiopulmonary bypass time, or surgery time in the b-ACP group. They cited another reason surgeons give for avoiding b-ACP: the risk of embolic injury caused by canulating the left common carotid artery in an atheromatous aorta. “In the present study, this risk was avoided by attaching the left common carotid artery to the four-branched prosthetic graft for left hemisphere perfusion,” Dr. Tong and coauthors wrote.
Key outcomes that the researchers found not statistically significant were:
- Overall 30-day mortality (11.6% for b-ACP vs. 20.7% for u-ACP; P = .075).
- Prevalence of postoperative permanent neurologic dysfunction (8.4% vs. 16.9%; P = .091).
- Average ICU LOS (16 ± 17.75 days vs. 17 ± 11.5 days, P =.454).
- Average hospital LOS (26.5 ± 20.6 days vs. 24.8 ± 10.3 days, P = .434).
However, average ventilation time was lower in the b-ACP group (95.5 hours vs. 147 hours; P less than or equal to.001).
Dr. Tong and coauthors used an aggressive approach, as advocated by Dhaval Trivedi, MD, and colleagues (Ann Thorac Surg. 2016;101:896-903), and had a total arch replacement rate of 57.8%. This rate is higher than most published series in the west but comparable to other studies from China, perhaps because of the relatively young age of this study cohort – an average age of 51 years – compared to data sets other studies have used. Dr. Tong and coauthors used a b-ACP strategy that established both cerebral perfusion routes before circulatory arrest.
Rates of the following complications were also not significantly different across the study population: paraplegia (2.8% for b-ACP vs. 3.1% for u-ACP), temporary neurologic dysfunction (4.7% vs. 9.2%), permanent neurologic dysfunction (8.4% vs. 16.9%), renal failure (18% vs. 23.1%), reoperation for bleeding (2.8% vs. 4.6%), and mediastinal infection (3.7% vs. 6.2%).
While b-ACP patients did not have a statistically significant lower incidence of TND, Dr. Tong and coauthors noted the shorter time on ventilation and significantly lower tracheostomy rates for the b-ACP patients, 3.7% vs. 16.9% for the u-ACP group (P = .003). “In our institute, protocols to wean patients from ventilation were normally initiated as soon as consciousness was regained,” Dr. Tong and coauthors wrote.
Among the study limits Dr. Tong and coauthors acknowledged were its retrospective, nonrandomized, single-center nature, and the fact that the surgeries were performed over an 8-year period representing different eras.
The investigators reported having no relevant financial disclosures.
What may be the largest study comparing unilateral and bilateral antegrade cerebral perfusion during total arch replacement for type A aortic dissection has reported that outcomes between the two approaches are comparable, although the bilateral approach showed some advantages during the operation itself, investigators from China reported in the Journal of Thoracic and Cardiovascular Surgery (2017;154:767-75).
The effectiveness of bilateral antegrade cerebral perfusion (b-ACP) vs. unilateral antegrade cerebral perfusion (u-ACP) has been the focus of extensive debate, lead study author Guang Tong, MD, of the Guangzhou (China) General Hospital, and coauthors said. They compared outcomes in six different metrics, ranging from cardiopulmonary bypass time to length of stay (LOS) in the ICU and hospital, in 203 patients with type A aortic dissection who had total aortic arch replacement with hypothermic circulatory arrest over an 8-year period ending in August 2014; 121 had b-ACP and 82 had u-ACP. “The issue of u-ACP vs. b-ACP has been examined in aortic arch surgery, but few reports have focused on type A aortic dissection,” Dr. Tong and coauthors wrote.
They acknowledged that some surgeons are reluctant to use b-ACP because of its complexity, but their study found no increase in cross-clamp time, cardiopulmonary bypass time, or surgery time in the b-ACP group. They cited another reason surgeons give for avoiding b-ACP: the risk of embolic injury caused by canulating the left common carotid artery in an atheromatous aorta. “In the present study, this risk was avoided by attaching the left common carotid artery to the four-branched prosthetic graft for left hemisphere perfusion,” Dr. Tong and coauthors wrote.
Key outcomes that the researchers found not statistically significant were:
- Overall 30-day mortality (11.6% for b-ACP vs. 20.7% for u-ACP; P = .075).
- Prevalence of postoperative permanent neurologic dysfunction (8.4% vs. 16.9%; P = .091).
- Average ICU LOS (16 ± 17.75 days vs. 17 ± 11.5 days, P =.454).
- Average hospital LOS (26.5 ± 20.6 days vs. 24.8 ± 10.3 days, P = .434).
However, average ventilation time was lower in the b-ACP group (95.5 hours vs. 147 hours; P less than or equal to.001).
Dr. Tong and coauthors used an aggressive approach, as advocated by Dhaval Trivedi, MD, and colleagues (Ann Thorac Surg. 2016;101:896-903), and had a total arch replacement rate of 57.8%. This rate is higher than most published series in the west but comparable to other studies from China, perhaps because of the relatively young age of this study cohort – an average age of 51 years – compared to data sets other studies have used. Dr. Tong and coauthors used a b-ACP strategy that established both cerebral perfusion routes before circulatory arrest.
Rates of the following complications were also not significantly different across the study population: paraplegia (2.8% for b-ACP vs. 3.1% for u-ACP), temporary neurologic dysfunction (4.7% vs. 9.2%), permanent neurologic dysfunction (8.4% vs. 16.9%), renal failure (18% vs. 23.1%), reoperation for bleeding (2.8% vs. 4.6%), and mediastinal infection (3.7% vs. 6.2%).
While b-ACP patients did not have a statistically significant lower incidence of TND, Dr. Tong and coauthors noted the shorter time on ventilation and significantly lower tracheostomy rates for the b-ACP patients, 3.7% vs. 16.9% for the u-ACP group (P = .003). “In our institute, protocols to wean patients from ventilation were normally initiated as soon as consciousness was regained,” Dr. Tong and coauthors wrote.
Among the study limits Dr. Tong and coauthors acknowledged were its retrospective, nonrandomized, single-center nature, and the fact that the surgeries were performed over an 8-year period representing different eras.
The investigators reported having no relevant financial disclosures.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Clinical outcomes were comparable between groups who underwent unilateral or bilateral antegrade cerebral perfusion in total arch replacement for type A aortic dissection.
Major finding: Overall 30-day mortality was 11.6% in the bilateral ACP group vs. 20.7% for unilateral ACP (P =.075).
Data source: Population of 203 patients who had aortic arch replacement surgery for type A aortic dissection between September 2006 and August 2014.
Disclosures: Dr. Tong and coauthors reported having no relevant financial disclosures.
Marketplace confusion opens door to questions about skinny plans
Consumers coping with the high cost of health insurance are the target market for new plans claiming to be lower-cost alternatives to the Affordable Care Act that fulfill the law’s requirement for health coverage.
But experts and regulators warn consumers to be cautious – and are raising red flags about one set of limited benefit plans marketed to individuals for as little as $93 a month. Offered through brokers and online ads, the plans promise to be an “ACA compliant, affordable, integrated solution that help ... individuals avoid the penalties under [the health care law].”
Such skinny plans – sold for the first time to individuals – come amid uncertainty over the fate of the ACA and whether the Trump administration will ease rules on plans for individuals. Dozens of brokers are offering the plans.
“The Trump administration is injecting a significant amount of confusion into the implementation of the ACA,” said Kevin Lucia, project director at Georgetown University’s Health Policy Institute. “So it doesn’t surprise me that we would have arrangements popping up that might be trying to take advantage of that confusion.”
Apex Management Group of the Chicago area and Pennsylvania-based Xpress Healthcare have teamed up to offer the plans, and executives from both companies say they don’t need approval from state regulators to sell them. They are selling the policies across the country, although their websites note one state – Massachusetts – where the plans are not offered.
David Shull, Apex’s director of business development, said “this is not insurance” and the plans are designed to meet the “bulk of someone’s day-to-day needs.”
Legal and policy experts have raised concerns that the new plans could leave buyers incorrectly thinking they are exempt from paying a penalty for not having coverage. Additionally, they say, plans sold to individuals must be state-licensed – and one regulator has already asked for an investigation.
“Generally speaking, any entity selling health insurance in the state of California has to have a license,” Dave Jones, the Golden State’s insurance commissioner, said earlier this month. “I have asked the Department of Insurance staff to open an investigation with regard to this company to ascertain whether it is in violation of California law if they are selling it in California.”
Asked about a possible investigation, Apex owner Jeffrey Bemoras emailed a statement last week saying the firm is not offering plans to individuals in California. He also noted that the individual market accounts for only 2% of the company’s business.
“To be clear, Apex Management group adheres closely to all state and federal rules and regulations surrounding offering a self-insured MEC [minimal essential coverage] program,” he wrote. “We are test marketing our product in the individual environment. If at some point it doesn’t make sense to continue that investment we will not invest or focus in on that market.”
Price-tag appeal, but what about coverage?
The new plans promise to be a solution for individuals who say that conventional health insurance is too expensive. Those looking for alternatives to the ACA often earn too much to qualify for tax subsidies under the federal law.
Donna Harper, an insurance agent who runs a two-person brokerage in Crystal Lake, Ill., found herself in that situation. She sells the Xpress plans – and decided to buy one herself.
Ms. Harper says she canceled her BlueCross BlueShield plan, which did meet the ACA’s requirements, after it rose to nearly $11,000 in premiums this year, with a $6,000 annual deductible.
“Self-employed people are being priced out of the market,” she said, noting the new Xpress plan will save her more than $500 a month.
The Xpress Minimum Essential Coverage plans come in three levels, costing as little as $93 a month for individuals to as much as $516 for a family. They cover preventive care – including certain cancer screenings and vaccinations – while providing limited benefits for doctor visits, lab tests, and lower-cost prescription drugs.
There is little or no coverage for hospital, emergency room care, and expensive prescription drugs, such as chemotherapy.
Ms. Harper said she generally recommends that her clients who sign up for an Xpress plan also buy a hospital-only policy offered by other insurers. That extra policy would pay a set amount toward inpatient care – often ranging from $1,500 to $5,000 or so a day.
Still, experts caution that hospital bills are generally much higher than those amounts. A three-day stay averages $30,000, according to the federal government’s insurance website. And hospital plans can have tougher requirements. Unlike the Xpress programs, which don’t reject applicants who have preexisting medical conditions, hospital-only plans often do. Ms. Harper says she personally was rejected for one.
“I haven’t been in the hospital for 40 years, so I’m going to roll the dice,” she said. And if she winds up in the hospital? “I’ll just pay the bill.”
About 100 brokers nationwide are selling the plans, and interest “is picking up quick,” said Edward Pettola, co-owner and founder of Xpress, which for years has sold programs that offer discounts on dental, vision, and prescription services.
Caveat emptor
Experts question whether the plans exempt policyholders from the ACA’s tax penalty for not having “qualified” coverage, defined as a policy from an employer, a government program or a licensed product purchased on the individual market.
The penalty for tax year 2017 is the greater of a flat fee or a percentage of income. The annual total could range from as little as $695 for an individual to as much as $3,264 for a family.
President Trump issued an executive order in October designed to loosen insurance restrictions on lower-cost, alternative forms of coverage, but the administration has not signaled its view on what would be deemed qualified coverage.
Responding to questions from KHN, officials from Apex and Xpress said their plans are designed to be affordable, not to mimic ACA health plans.
“If that is what we are expected to do, just deliver what every Marketplace plan or carriers do, provide a Bronze, Silver Plan, etc., it would not solve the problem in addressing a benefit plan that is affordable,” the companies said in a joint email on Nov. 14. “Individuals are not required to have an insurance plan, but a plan that meets minimum essential coverage, the required preventive care services.”
Mr. Bemoras, in a separate interview, said his company has been selling a version of the plan to employers since 2015.
“As we see the political environment moving and wavering and not understanding what needs to be done, the individual market became extremely attractive to us,” Mr. Bemoras said.
Still, experts who reviewed the plans for KHN said policies sold to individuals must cover 10 broad categories of health care to qualify as ACA-compliant, including hospitalization and emergency room care, and cannot set annual or lifetime limits.
The Xpress/Apex programs do set limits, paying zero to $2,500 annually toward hospital care. Doctor visits are covered for a $20 copayment, but coverage is limited to three per year. Lab tests are limited to 5 services annually. To get those prices, patients have to use a physician or facility in the PHCS network, which says it has 900,000 providers nationwide. Low-cost generics are covered for as little as a $1 copay, but the amount patients pay rises sharply for more expensive drugs.
“I’m very skeptical,” said attorney Alden J. Bianchi of Mintz Levin, who advises firms on employee benefits. “That would be hard [to do] because in the individual market, you have to cover all the essential health benefits.”
The details can be confusing, partly because federal law allows group health plans – generally those offered by large employers – to provide workers with self-funded, minimal coverage plans like those offered by Apex, Mr. Bianchi said.
Apex’s Mr. Shull recently said in an email that the firm simply wants to offer coverage to people who otherwise could not afford an ACA plan.
“There will be states that want to halt this. Why, I do not understand,” he wrote. “Would an individual be better off going without anything? If they need prescriptions, lab or imaging services subject to a small copay, would you want to be the one to deny them?”
Some consumers might find the price attractive, but also find themselves vulnerable to unexpected costs, including the tax liability.
Ms. Harper, the broker who signed up for one of the plans, remains confident: “As long as Xpress satisfies the [mandate], which I’m told it does, my clients are in good hands. Even if it doesn’t, I don’t think it’s a big deal. You are saving that [the tax penalty amount] a month.”
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Consumers coping with the high cost of health insurance are the target market for new plans claiming to be lower-cost alternatives to the Affordable Care Act that fulfill the law’s requirement for health coverage.
But experts and regulators warn consumers to be cautious – and are raising red flags about one set of limited benefit plans marketed to individuals for as little as $93 a month. Offered through brokers and online ads, the plans promise to be an “ACA compliant, affordable, integrated solution that help ... individuals avoid the penalties under [the health care law].”
Such skinny plans – sold for the first time to individuals – come amid uncertainty over the fate of the ACA and whether the Trump administration will ease rules on plans for individuals. Dozens of brokers are offering the plans.
“The Trump administration is injecting a significant amount of confusion into the implementation of the ACA,” said Kevin Lucia, project director at Georgetown University’s Health Policy Institute. “So it doesn’t surprise me that we would have arrangements popping up that might be trying to take advantage of that confusion.”
Apex Management Group of the Chicago area and Pennsylvania-based Xpress Healthcare have teamed up to offer the plans, and executives from both companies say they don’t need approval from state regulators to sell them. They are selling the policies across the country, although their websites note one state – Massachusetts – where the plans are not offered.
David Shull, Apex’s director of business development, said “this is not insurance” and the plans are designed to meet the “bulk of someone’s day-to-day needs.”
Legal and policy experts have raised concerns that the new plans could leave buyers incorrectly thinking they are exempt from paying a penalty for not having coverage. Additionally, they say, plans sold to individuals must be state-licensed – and one regulator has already asked for an investigation.
“Generally speaking, any entity selling health insurance in the state of California has to have a license,” Dave Jones, the Golden State’s insurance commissioner, said earlier this month. “I have asked the Department of Insurance staff to open an investigation with regard to this company to ascertain whether it is in violation of California law if they are selling it in California.”
Asked about a possible investigation, Apex owner Jeffrey Bemoras emailed a statement last week saying the firm is not offering plans to individuals in California. He also noted that the individual market accounts for only 2% of the company’s business.
“To be clear, Apex Management group adheres closely to all state and federal rules and regulations surrounding offering a self-insured MEC [minimal essential coverage] program,” he wrote. “We are test marketing our product in the individual environment. If at some point it doesn’t make sense to continue that investment we will not invest or focus in on that market.”
Price-tag appeal, but what about coverage?
The new plans promise to be a solution for individuals who say that conventional health insurance is too expensive. Those looking for alternatives to the ACA often earn too much to qualify for tax subsidies under the federal law.
Donna Harper, an insurance agent who runs a two-person brokerage in Crystal Lake, Ill., found herself in that situation. She sells the Xpress plans – and decided to buy one herself.
Ms. Harper says she canceled her BlueCross BlueShield plan, which did meet the ACA’s requirements, after it rose to nearly $11,000 in premiums this year, with a $6,000 annual deductible.
“Self-employed people are being priced out of the market,” she said, noting the new Xpress plan will save her more than $500 a month.
The Xpress Minimum Essential Coverage plans come in three levels, costing as little as $93 a month for individuals to as much as $516 for a family. They cover preventive care – including certain cancer screenings and vaccinations – while providing limited benefits for doctor visits, lab tests, and lower-cost prescription drugs.
There is little or no coverage for hospital, emergency room care, and expensive prescription drugs, such as chemotherapy.
Ms. Harper said she generally recommends that her clients who sign up for an Xpress plan also buy a hospital-only policy offered by other insurers. That extra policy would pay a set amount toward inpatient care – often ranging from $1,500 to $5,000 or so a day.
Still, experts caution that hospital bills are generally much higher than those amounts. A three-day stay averages $30,000, according to the federal government’s insurance website. And hospital plans can have tougher requirements. Unlike the Xpress programs, which don’t reject applicants who have preexisting medical conditions, hospital-only plans often do. Ms. Harper says she personally was rejected for one.
“I haven’t been in the hospital for 40 years, so I’m going to roll the dice,” she said. And if she winds up in the hospital? “I’ll just pay the bill.”
About 100 brokers nationwide are selling the plans, and interest “is picking up quick,” said Edward Pettola, co-owner and founder of Xpress, which for years has sold programs that offer discounts on dental, vision, and prescription services.
Caveat emptor
Experts question whether the plans exempt policyholders from the ACA’s tax penalty for not having “qualified” coverage, defined as a policy from an employer, a government program or a licensed product purchased on the individual market.
The penalty for tax year 2017 is the greater of a flat fee or a percentage of income. The annual total could range from as little as $695 for an individual to as much as $3,264 for a family.
President Trump issued an executive order in October designed to loosen insurance restrictions on lower-cost, alternative forms of coverage, but the administration has not signaled its view on what would be deemed qualified coverage.
Responding to questions from KHN, officials from Apex and Xpress said their plans are designed to be affordable, not to mimic ACA health plans.
“If that is what we are expected to do, just deliver what every Marketplace plan or carriers do, provide a Bronze, Silver Plan, etc., it would not solve the problem in addressing a benefit plan that is affordable,” the companies said in a joint email on Nov. 14. “Individuals are not required to have an insurance plan, but a plan that meets minimum essential coverage, the required preventive care services.”
Mr. Bemoras, in a separate interview, said his company has been selling a version of the plan to employers since 2015.
“As we see the political environment moving and wavering and not understanding what needs to be done, the individual market became extremely attractive to us,” Mr. Bemoras said.
Still, experts who reviewed the plans for KHN said policies sold to individuals must cover 10 broad categories of health care to qualify as ACA-compliant, including hospitalization and emergency room care, and cannot set annual or lifetime limits.
The Xpress/Apex programs do set limits, paying zero to $2,500 annually toward hospital care. Doctor visits are covered for a $20 copayment, but coverage is limited to three per year. Lab tests are limited to 5 services annually. To get those prices, patients have to use a physician or facility in the PHCS network, which says it has 900,000 providers nationwide. Low-cost generics are covered for as little as a $1 copay, but the amount patients pay rises sharply for more expensive drugs.
“I’m very skeptical,” said attorney Alden J. Bianchi of Mintz Levin, who advises firms on employee benefits. “That would be hard [to do] because in the individual market, you have to cover all the essential health benefits.”
The details can be confusing, partly because federal law allows group health plans – generally those offered by large employers – to provide workers with self-funded, minimal coverage plans like those offered by Apex, Mr. Bianchi said.
Apex’s Mr. Shull recently said in an email that the firm simply wants to offer coverage to people who otherwise could not afford an ACA plan.
“There will be states that want to halt this. Why, I do not understand,” he wrote. “Would an individual be better off going without anything? If they need prescriptions, lab or imaging services subject to a small copay, would you want to be the one to deny them?”
Some consumers might find the price attractive, but also find themselves vulnerable to unexpected costs, including the tax liability.
Ms. Harper, the broker who signed up for one of the plans, remains confident: “As long as Xpress satisfies the [mandate], which I’m told it does, my clients are in good hands. Even if it doesn’t, I don’t think it’s a big deal. You are saving that [the tax penalty amount] a month.”
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Consumers coping with the high cost of health insurance are the target market for new plans claiming to be lower-cost alternatives to the Affordable Care Act that fulfill the law’s requirement for health coverage.
But experts and regulators warn consumers to be cautious – and are raising red flags about one set of limited benefit plans marketed to individuals for as little as $93 a month. Offered through brokers and online ads, the plans promise to be an “ACA compliant, affordable, integrated solution that help ... individuals avoid the penalties under [the health care law].”
Such skinny plans – sold for the first time to individuals – come amid uncertainty over the fate of the ACA and whether the Trump administration will ease rules on plans for individuals. Dozens of brokers are offering the plans.
“The Trump administration is injecting a significant amount of confusion into the implementation of the ACA,” said Kevin Lucia, project director at Georgetown University’s Health Policy Institute. “So it doesn’t surprise me that we would have arrangements popping up that might be trying to take advantage of that confusion.”
Apex Management Group of the Chicago area and Pennsylvania-based Xpress Healthcare have teamed up to offer the plans, and executives from both companies say they don’t need approval from state regulators to sell them. They are selling the policies across the country, although their websites note one state – Massachusetts – where the plans are not offered.
David Shull, Apex’s director of business development, said “this is not insurance” and the plans are designed to meet the “bulk of someone’s day-to-day needs.”
Legal and policy experts have raised concerns that the new plans could leave buyers incorrectly thinking they are exempt from paying a penalty for not having coverage. Additionally, they say, plans sold to individuals must be state-licensed – and one regulator has already asked for an investigation.
“Generally speaking, any entity selling health insurance in the state of California has to have a license,” Dave Jones, the Golden State’s insurance commissioner, said earlier this month. “I have asked the Department of Insurance staff to open an investigation with regard to this company to ascertain whether it is in violation of California law if they are selling it in California.”
Asked about a possible investigation, Apex owner Jeffrey Bemoras emailed a statement last week saying the firm is not offering plans to individuals in California. He also noted that the individual market accounts for only 2% of the company’s business.
“To be clear, Apex Management group adheres closely to all state and federal rules and regulations surrounding offering a self-insured MEC [minimal essential coverage] program,” he wrote. “We are test marketing our product in the individual environment. If at some point it doesn’t make sense to continue that investment we will not invest or focus in on that market.”
Price-tag appeal, but what about coverage?
The new plans promise to be a solution for individuals who say that conventional health insurance is too expensive. Those looking for alternatives to the ACA often earn too much to qualify for tax subsidies under the federal law.
Donna Harper, an insurance agent who runs a two-person brokerage in Crystal Lake, Ill., found herself in that situation. She sells the Xpress plans – and decided to buy one herself.
Ms. Harper says she canceled her BlueCross BlueShield plan, which did meet the ACA’s requirements, after it rose to nearly $11,000 in premiums this year, with a $6,000 annual deductible.
“Self-employed people are being priced out of the market,” she said, noting the new Xpress plan will save her more than $500 a month.
The Xpress Minimum Essential Coverage plans come in three levels, costing as little as $93 a month for individuals to as much as $516 for a family. They cover preventive care – including certain cancer screenings and vaccinations – while providing limited benefits for doctor visits, lab tests, and lower-cost prescription drugs.
There is little or no coverage for hospital, emergency room care, and expensive prescription drugs, such as chemotherapy.
Ms. Harper said she generally recommends that her clients who sign up for an Xpress plan also buy a hospital-only policy offered by other insurers. That extra policy would pay a set amount toward inpatient care – often ranging from $1,500 to $5,000 or so a day.
Still, experts caution that hospital bills are generally much higher than those amounts. A three-day stay averages $30,000, according to the federal government’s insurance website. And hospital plans can have tougher requirements. Unlike the Xpress programs, which don’t reject applicants who have preexisting medical conditions, hospital-only plans often do. Ms. Harper says she personally was rejected for one.
“I haven’t been in the hospital for 40 years, so I’m going to roll the dice,” she said. And if she winds up in the hospital? “I’ll just pay the bill.”
About 100 brokers nationwide are selling the plans, and interest “is picking up quick,” said Edward Pettola, co-owner and founder of Xpress, which for years has sold programs that offer discounts on dental, vision, and prescription services.
Caveat emptor
Experts question whether the plans exempt policyholders from the ACA’s tax penalty for not having “qualified” coverage, defined as a policy from an employer, a government program or a licensed product purchased on the individual market.
The penalty for tax year 2017 is the greater of a flat fee or a percentage of income. The annual total could range from as little as $695 for an individual to as much as $3,264 for a family.
President Trump issued an executive order in October designed to loosen insurance restrictions on lower-cost, alternative forms of coverage, but the administration has not signaled its view on what would be deemed qualified coverage.
Responding to questions from KHN, officials from Apex and Xpress said their plans are designed to be affordable, not to mimic ACA health plans.
“If that is what we are expected to do, just deliver what every Marketplace plan or carriers do, provide a Bronze, Silver Plan, etc., it would not solve the problem in addressing a benefit plan that is affordable,” the companies said in a joint email on Nov. 14. “Individuals are not required to have an insurance plan, but a plan that meets minimum essential coverage, the required preventive care services.”
Mr. Bemoras, in a separate interview, said his company has been selling a version of the plan to employers since 2015.
“As we see the political environment moving and wavering and not understanding what needs to be done, the individual market became extremely attractive to us,” Mr. Bemoras said.
Still, experts who reviewed the plans for KHN said policies sold to individuals must cover 10 broad categories of health care to qualify as ACA-compliant, including hospitalization and emergency room care, and cannot set annual or lifetime limits.
The Xpress/Apex programs do set limits, paying zero to $2,500 annually toward hospital care. Doctor visits are covered for a $20 copayment, but coverage is limited to three per year. Lab tests are limited to 5 services annually. To get those prices, patients have to use a physician or facility in the PHCS network, which says it has 900,000 providers nationwide. Low-cost generics are covered for as little as a $1 copay, but the amount patients pay rises sharply for more expensive drugs.
“I’m very skeptical,” said attorney Alden J. Bianchi of Mintz Levin, who advises firms on employee benefits. “That would be hard [to do] because in the individual market, you have to cover all the essential health benefits.”
The details can be confusing, partly because federal law allows group health plans – generally those offered by large employers – to provide workers with self-funded, minimal coverage plans like those offered by Apex, Mr. Bianchi said.
Apex’s Mr. Shull recently said in an email that the firm simply wants to offer coverage to people who otherwise could not afford an ACA plan.
“There will be states that want to halt this. Why, I do not understand,” he wrote. “Would an individual be better off going without anything? If they need prescriptions, lab or imaging services subject to a small copay, would you want to be the one to deny them?”
Some consumers might find the price attractive, but also find themselves vulnerable to unexpected costs, including the tax liability.
Ms. Harper, the broker who signed up for one of the plans, remains confident: “As long as Xpress satisfies the [mandate], which I’m told it does, my clients are in good hands. Even if it doesn’t, I don’t think it’s a big deal. You are saving that [the tax penalty amount] a month.”
Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
REBOA improves survival for trauma patients
SCOTTSDALE, ARIZ. – In a small, single-center study of patients with subdiaphragmatic hemorrhage, resuscitative endovascular balloon occlusion of the aorta (REBOA) improved hemodynamic status and 30-day survival rates, compared with resuscitative thoracotomy (RT).
Although the technique was first developed during the Korean War, REBOA never really caught on, possibly because of limitations in endovascular technology. But recent advances in surgical technique have revitalized interest.
Despite the success of the study, some audience members expressed concerns about the skill set required. One questioner pointed out that emergency department physicians may be tempted to use the technique, even though they may not possess the requisite catheter and wire skills. That is a legitimate concern, according to senior author R. Stephen Smith, MD, FACS, professor of acute care surgery at the University of Florida, Gainesville. But this is already happening, he said. “They’ve already done it in the field in Britain, and most are placed by nonsurgeons in Japan. Frankly, we need to pay particular attention to the skills of those emergency medicine physicians, because the average emergency medicine physician at this point really doesn’t have the catheter or wire-based skills to do this safely,” Dr. Smith said at the annual meeting of the Western Surgical Association.
The researchers examined outcomes in patients who underwent REBOA versus RT over a 21-month (2015-2017) period at their institution. Before adopting REBOA, attending surgeons and senior surgical residents attended a 1.5-hour slide presentation combined with simulation training. No external course was required. Operating room personnel received a 30-minute slide presentation. The procedures were conducted in a dedicated trauma operating room equipped with imaging.
Sixteen patients underwent REBOA during the study period, with a mean injury severity score of 38.6. Preoperative hemoglobin levels ranged from 5 to 14.4 mg/dL, and the majority were acidotic because of trauma.
Fourteen of the 16 patients who underwent REBOA survived the operative procedure, and 6 survived to 30 days. By contrast, 8 patients were treated with RT, and none survived to 30 days. Ten of the 16 patients who underwent REBOA experienced an improvement in hemodynamic status, with systolic blood pressure improving to a mean of 131.83 mm Hg (±8.24) and improvement of heart rate to 87.5 (±5.47). One survivor developed a common femoral pseudoaneurysm.
Compared with nonsurvivors, REBOA patients who survived had a significant increase in Initial Glasgow Coma scores (15.0 vs. 6.18; P less than .05), and higher initial platelet counts (276.40 vs. 124.75; P = .01). Survivors also had higher initial postoperative systolic blood pressure (151.40 mm Hg vs. 112.33; P = .05), and a higher mean postoperative arterial blood pressure (109.00 mm Hg vs. 72.78; P = .01).
Overall, the findings were similar to those reported in previous multicenter trials.
The researchers pointed out that REBOA does not replace RT. The latter procedure is still appropriate for some moribund patients with super-diaphragmatic injury and in patients who require open cardiac massage.
The techniques are not mutually exclusive – two patients in the sample were treated with both techniques.
The researchers also mentioned some future possibilities for REBOA. Research in animals has demonstrated the promise of partial REBOA, in which an automated system can partially inflate the balloon and gradually deflate it as the patient’s vital signs improve. That can lighten the load for surgeons and anesthesiologists, according to Dr. Smith. “We look forward to developing that technology in the future,” he said.
The funding source was not disclosed. Dr. Smith is on the speakers bureau for Prytime Medical and is a consultant for Boehringer Laboratory LLC.
SCOTTSDALE, ARIZ. – In a small, single-center study of patients with subdiaphragmatic hemorrhage, resuscitative endovascular balloon occlusion of the aorta (REBOA) improved hemodynamic status and 30-day survival rates, compared with resuscitative thoracotomy (RT).
Although the technique was first developed during the Korean War, REBOA never really caught on, possibly because of limitations in endovascular technology. But recent advances in surgical technique have revitalized interest.
Despite the success of the study, some audience members expressed concerns about the skill set required. One questioner pointed out that emergency department physicians may be tempted to use the technique, even though they may not possess the requisite catheter and wire skills. That is a legitimate concern, according to senior author R. Stephen Smith, MD, FACS, professor of acute care surgery at the University of Florida, Gainesville. But this is already happening, he said. “They’ve already done it in the field in Britain, and most are placed by nonsurgeons in Japan. Frankly, we need to pay particular attention to the skills of those emergency medicine physicians, because the average emergency medicine physician at this point really doesn’t have the catheter or wire-based skills to do this safely,” Dr. Smith said at the annual meeting of the Western Surgical Association.
The researchers examined outcomes in patients who underwent REBOA versus RT over a 21-month (2015-2017) period at their institution. Before adopting REBOA, attending surgeons and senior surgical residents attended a 1.5-hour slide presentation combined with simulation training. No external course was required. Operating room personnel received a 30-minute slide presentation. The procedures were conducted in a dedicated trauma operating room equipped with imaging.
Sixteen patients underwent REBOA during the study period, with a mean injury severity score of 38.6. Preoperative hemoglobin levels ranged from 5 to 14.4 mg/dL, and the majority were acidotic because of trauma.
Fourteen of the 16 patients who underwent REBOA survived the operative procedure, and 6 survived to 30 days. By contrast, 8 patients were treated with RT, and none survived to 30 days. Ten of the 16 patients who underwent REBOA experienced an improvement in hemodynamic status, with systolic blood pressure improving to a mean of 131.83 mm Hg (±8.24) and improvement of heart rate to 87.5 (±5.47). One survivor developed a common femoral pseudoaneurysm.
Compared with nonsurvivors, REBOA patients who survived had a significant increase in Initial Glasgow Coma scores (15.0 vs. 6.18; P less than .05), and higher initial platelet counts (276.40 vs. 124.75; P = .01). Survivors also had higher initial postoperative systolic blood pressure (151.40 mm Hg vs. 112.33; P = .05), and a higher mean postoperative arterial blood pressure (109.00 mm Hg vs. 72.78; P = .01).
Overall, the findings were similar to those reported in previous multicenter trials.
The researchers pointed out that REBOA does not replace RT. The latter procedure is still appropriate for some moribund patients with super-diaphragmatic injury and in patients who require open cardiac massage.
The techniques are not mutually exclusive – two patients in the sample were treated with both techniques.
The researchers also mentioned some future possibilities for REBOA. Research in animals has demonstrated the promise of partial REBOA, in which an automated system can partially inflate the balloon and gradually deflate it as the patient’s vital signs improve. That can lighten the load for surgeons and anesthesiologists, according to Dr. Smith. “We look forward to developing that technology in the future,” he said.
The funding source was not disclosed. Dr. Smith is on the speakers bureau for Prytime Medical and is a consultant for Boehringer Laboratory LLC.
SCOTTSDALE, ARIZ. – In a small, single-center study of patients with subdiaphragmatic hemorrhage, resuscitative endovascular balloon occlusion of the aorta (REBOA) improved hemodynamic status and 30-day survival rates, compared with resuscitative thoracotomy (RT).
Although the technique was first developed during the Korean War, REBOA never really caught on, possibly because of limitations in endovascular technology. But recent advances in surgical technique have revitalized interest.
Despite the success of the study, some audience members expressed concerns about the skill set required. One questioner pointed out that emergency department physicians may be tempted to use the technique, even though they may not possess the requisite catheter and wire skills. That is a legitimate concern, according to senior author R. Stephen Smith, MD, FACS, professor of acute care surgery at the University of Florida, Gainesville. But this is already happening, he said. “They’ve already done it in the field in Britain, and most are placed by nonsurgeons in Japan. Frankly, we need to pay particular attention to the skills of those emergency medicine physicians, because the average emergency medicine physician at this point really doesn’t have the catheter or wire-based skills to do this safely,” Dr. Smith said at the annual meeting of the Western Surgical Association.
The researchers examined outcomes in patients who underwent REBOA versus RT over a 21-month (2015-2017) period at their institution. Before adopting REBOA, attending surgeons and senior surgical residents attended a 1.5-hour slide presentation combined with simulation training. No external course was required. Operating room personnel received a 30-minute slide presentation. The procedures were conducted in a dedicated trauma operating room equipped with imaging.
Sixteen patients underwent REBOA during the study period, with a mean injury severity score of 38.6. Preoperative hemoglobin levels ranged from 5 to 14.4 mg/dL, and the majority were acidotic because of trauma.
Fourteen of the 16 patients who underwent REBOA survived the operative procedure, and 6 survived to 30 days. By contrast, 8 patients were treated with RT, and none survived to 30 days. Ten of the 16 patients who underwent REBOA experienced an improvement in hemodynamic status, with systolic blood pressure improving to a mean of 131.83 mm Hg (±8.24) and improvement of heart rate to 87.5 (±5.47). One survivor developed a common femoral pseudoaneurysm.
Compared with nonsurvivors, REBOA patients who survived had a significant increase in Initial Glasgow Coma scores (15.0 vs. 6.18; P less than .05), and higher initial platelet counts (276.40 vs. 124.75; P = .01). Survivors also had higher initial postoperative systolic blood pressure (151.40 mm Hg vs. 112.33; P = .05), and a higher mean postoperative arterial blood pressure (109.00 mm Hg vs. 72.78; P = .01).
Overall, the findings were similar to those reported in previous multicenter trials.
The researchers pointed out that REBOA does not replace RT. The latter procedure is still appropriate for some moribund patients with super-diaphragmatic injury and in patients who require open cardiac massage.
The techniques are not mutually exclusive – two patients in the sample were treated with both techniques.
The researchers also mentioned some future possibilities for REBOA. Research in animals has demonstrated the promise of partial REBOA, in which an automated system can partially inflate the balloon and gradually deflate it as the patient’s vital signs improve. That can lighten the load for surgeons and anesthesiologists, according to Dr. Smith. “We look forward to developing that technology in the future,” he said.
The funding source was not disclosed. Dr. Smith is on the speakers bureau for Prytime Medical and is a consultant for Boehringer Laboratory LLC.
AT WSA 2017
Key clinical point: REBOA improved hematological outcomes and survival rates, compared with resuscitative thoracotomy.
Major finding: Six of 16 patients in the REBOA group survived to 30 days, compared with none of the 8 resuscitative thoracotomy patients.
Data source: Retrospective analysis of 24 patients at a single center.
Disclosures: The funding source was not disclosed. Dr. Smith is on the speakers bureau for Prytime Medical and is a consultant for Boehringer Laboratory LLC.
Safety-net hospitals would be hurt by hospital-wide 30-day readmission penalties
Considering all readmissions within 30 days of discharge in the Hospital Readmissions Reduction Program would modestly increase the number of hospitals eligible for penalties and would have a bigger impact on safety-net hospitals, based on a study of two years of Medicare claims data from 3,443 hospitals.
“Transition to a hospital-wide measure would require an adjustment in the penalty formula to keep penalties in the same range for most hospitals and without a change in procedures would have a deleterious effect on safety-net hospitals,” according to Rachael B. Zuckerman, PhD, from the Department of Health and Human Services, Washington, and her co-authors.
Analyzing 6,807,899 admissions for hospital-wide readmission measures and 4,392,658 admissions for condition-specific measures, the researchers found that a condition-specific approach would result in 3,238 hospitals being eligible for penalties for at least one condition. A hospital-wide measure of readmissions would result in 76 additional hospitals being eligible for penalties based on one year of admissions data, and 128 additional hospitals based on 3 years of admissions data (NEJM 2017, 377:1551-58. DOI: 10.1056/NEJMsa1701791).
Moving to a hospital-wide measure of readmissions also would significantly increase mean annual penalty rates across all hospitals by 0.89% of base diagnosis-related group (DRG) payments or $393,000; 43% of hospitals would be penalized under this standard.
“Moving to the hospital-wide readmission measure would also substantially increase the disparity between safety-net and other hospitals: the mean penalty as a percentage of base DRG payments would be 0.41 percentage points ($198,000) higher among safety net hospitals,” the authors wrote.
“Since safety-net hospitals tend to perform slightly worse on the hospital-wide measure, they are more likely to receive a penalty, which would increase the disparity in penalties between the two groups.”
The study was supported by the Department of Health and Human Services. One author declared grants from funding bodies and universities outside the submitted work. One author is an associate editor of the New England Journal of Medicine. One author was an employee of the Department of Health and Human Services at the time of the study. No other conflicts of interest were declared.
Considering all readmissions within 30 days of discharge in the Hospital Readmissions Reduction Program would modestly increase the number of hospitals eligible for penalties and would have a bigger impact on safety-net hospitals, based on a study of two years of Medicare claims data from 3,443 hospitals.
“Transition to a hospital-wide measure would require an adjustment in the penalty formula to keep penalties in the same range for most hospitals and without a change in procedures would have a deleterious effect on safety-net hospitals,” according to Rachael B. Zuckerman, PhD, from the Department of Health and Human Services, Washington, and her co-authors.
Analyzing 6,807,899 admissions for hospital-wide readmission measures and 4,392,658 admissions for condition-specific measures, the researchers found that a condition-specific approach would result in 3,238 hospitals being eligible for penalties for at least one condition. A hospital-wide measure of readmissions would result in 76 additional hospitals being eligible for penalties based on one year of admissions data, and 128 additional hospitals based on 3 years of admissions data (NEJM 2017, 377:1551-58. DOI: 10.1056/NEJMsa1701791).
Moving to a hospital-wide measure of readmissions also would significantly increase mean annual penalty rates across all hospitals by 0.89% of base diagnosis-related group (DRG) payments or $393,000; 43% of hospitals would be penalized under this standard.
“Moving to the hospital-wide readmission measure would also substantially increase the disparity between safety-net and other hospitals: the mean penalty as a percentage of base DRG payments would be 0.41 percentage points ($198,000) higher among safety net hospitals,” the authors wrote.
“Since safety-net hospitals tend to perform slightly worse on the hospital-wide measure, they are more likely to receive a penalty, which would increase the disparity in penalties between the two groups.”
The study was supported by the Department of Health and Human Services. One author declared grants from funding bodies and universities outside the submitted work. One author is an associate editor of the New England Journal of Medicine. One author was an employee of the Department of Health and Human Services at the time of the study. No other conflicts of interest were declared.
Considering all readmissions within 30 days of discharge in the Hospital Readmissions Reduction Program would modestly increase the number of hospitals eligible for penalties and would have a bigger impact on safety-net hospitals, based on a study of two years of Medicare claims data from 3,443 hospitals.
“Transition to a hospital-wide measure would require an adjustment in the penalty formula to keep penalties in the same range for most hospitals and without a change in procedures would have a deleterious effect on safety-net hospitals,” according to Rachael B. Zuckerman, PhD, from the Department of Health and Human Services, Washington, and her co-authors.
Analyzing 6,807,899 admissions for hospital-wide readmission measures and 4,392,658 admissions for condition-specific measures, the researchers found that a condition-specific approach would result in 3,238 hospitals being eligible for penalties for at least one condition. A hospital-wide measure of readmissions would result in 76 additional hospitals being eligible for penalties based on one year of admissions data, and 128 additional hospitals based on 3 years of admissions data (NEJM 2017, 377:1551-58. DOI: 10.1056/NEJMsa1701791).
Moving to a hospital-wide measure of readmissions also would significantly increase mean annual penalty rates across all hospitals by 0.89% of base diagnosis-related group (DRG) payments or $393,000; 43% of hospitals would be penalized under this standard.
“Moving to the hospital-wide readmission measure would also substantially increase the disparity between safety-net and other hospitals: the mean penalty as a percentage of base DRG payments would be 0.41 percentage points ($198,000) higher among safety net hospitals,” the authors wrote.
“Since safety-net hospitals tend to perform slightly worse on the hospital-wide measure, they are more likely to receive a penalty, which would increase the disparity in penalties between the two groups.”
The study was supported by the Department of Health and Human Services. One author declared grants from funding bodies and universities outside the submitted work. One author is an associate editor of the New England Journal of Medicine. One author was an employee of the Department of Health and Human Services at the time of the study. No other conflicts of interest were declared.
FROM NEJM
Key clinical point: Adopting a hospital-wide measure of 30-day readmissions for the Hospital Readmissions Reduction Program would modestly increase the number of hospitals eligible for penalties and would have a bigger impact on safety-net hospitals.
Major finding: With a hospital-wide measure of readmissions in the Hospital Readmissions Reduction Program, the mean penalty as a percentage of base DRG payments would be 0.41 percentage points ($198,000) higher among safety net hospitals.
Data source: Analysis of two years of Medicare claims data from 3,443 hospitals.
Disclosures: The study was supported by the Department of Health and Human Services. One author declared grants from funding bodies and universities outside the submitted work. One author is an associated editor of the New England Journal of Medicine. One author was an employee of the Department of Health and Human Services at the time of the study. No other conflicts of interest were declared.