Patricia McKnight

A San Antonio oncology practice and diagnostic reference laboratory have agreed to settle a federal lawsuit, which alleged the two entities had entered an unlawful kickback arrangement.

The US Department of Justice (DOJ) announced on April 2 that Oncology San Antonio, PA, and its physicians have agreed to pay $1.3 million, and CorePath Laboratories, PA, has agreed to pay nearly $2.75 million plus accrued interest in civil settlements with the United States and Texas for alleged violations of the False Claims Act.

According to the DOJ, the diagnostic reference laboratory, CorePath Laboratories, conducted in-office bone marrow biopsies at Oncology San Antonio practice locations and performed diagnostic testing on the samples. CorePath Laboratories agreed to pay $115 for each biopsy referred by Oncology San Antonio physicians, and these biopsy payments were allegedly paid to the private practices of three physicians at Oncology San Antonio. This arrangement allegedly began in August 2016.

The DOJ claimed that the payments for referring biopsies constituted illegal kickbacks under the Anti-Kickback Statute, which prohibits offering or receiving payments to encourage referrals of services covered by federal healthcare programs like Medicare and Medicaid.

“Violations of the Anti-Kickback Statute involving oncology services can waste scarce federal healthcare program funds and corrupt the medical decision-making process,” Special Agent in Charge Jason E. Meadows with the US Department of Health and Human Services Office of Inspector General said in a statement.

Oncology San Antonio told this news organization that the cost and distraction of prolonged litigation were the primary factors in its decision to settle. “The decision to settle was an extremely difficult one because Oncology San Antonio was confident that it would have prevailed in any action,” the practice said via email.

This civil settlement with Oncology San Antonio also resolved allegations that a physician affiliated with the practice, Jayasree Rao, MD, provided unnecessary tests, services, and treatments to patients covered by Medicare, TRICARE, and Texas Medicaid in the San Antonio Metro Area and billed these federal healthcare programs for the unnecessary services.

The DOJ identified Slavisa Gasic, MD, a physician formerly employed by Dr. Rao, as a whistleblower in the investigation. When asked for comment, Oncology San Antonio alleged Dr. Gasic was “disgruntled for not being promoted.”

According to Oncology San Antonio, the contract for bone marrow biopsies was negotiated and signed by a former nonphysician officer of the company without the input of Oncology San Antonio physicians. The contract permitted bone marrow biopsies at Oncology San Antonio clinics instead of requiring older adult and sick patients to go to a different facility for these services.

“Oncology San Antonio and Rao vehemently denied Gasic’s allegations as wholly unfounded,” the company told this news organization.

Dr. Rao retired in March and is no longer practicing. CorePath Laboratories, PA, did not respond to this news organization’s request for comment.

According to the DOJ press release, the “investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud.”
 

A version of this article appeared on Medscape.com.

A San Antonio oncology practice and diagnostic reference laboratory have agreed to settle a federal lawsuit, which alleged the two entities had entered an unlawful kickback arrangement.

The US Department of Justice (DOJ) announced on April 2 that Oncology San Antonio, PA, and its physicians have agreed to pay $1.3 million, and CorePath Laboratories, PA, has agreed to pay nearly $2.75 million plus accrued interest in civil settlements with the United States and Texas for alleged violations of the False Claims Act.

According to the DOJ, the diagnostic reference laboratory, CorePath Laboratories, conducted in-office bone marrow biopsies at Oncology San Antonio practice locations and performed diagnostic testing on the samples. CorePath Laboratories agreed to pay $115 for each biopsy referred by Oncology San Antonio physicians, and these biopsy payments were allegedly paid to the private practices of three physicians at Oncology San Antonio. This arrangement allegedly began in August 2016.

The DOJ claimed that the payments for referring biopsies constituted illegal kickbacks under the Anti-Kickback Statute, which prohibits offering or receiving payments to encourage referrals of services covered by federal healthcare programs like Medicare and Medicaid.

“Violations of the Anti-Kickback Statute involving oncology services can waste scarce federal healthcare program funds and corrupt the medical decision-making process,” Special Agent in Charge Jason E. Meadows with the US Department of Health and Human Services Office of Inspector General said in a statement.

Oncology San Antonio told this news organization that the cost and distraction of prolonged litigation were the primary factors in its decision to settle. “The decision to settle was an extremely difficult one because Oncology San Antonio was confident that it would have prevailed in any action,” the practice said via email.

This civil settlement with Oncology San Antonio also resolved allegations that a physician affiliated with the practice, Jayasree Rao, MD, provided unnecessary tests, services, and treatments to patients covered by Medicare, TRICARE, and Texas Medicaid in the San Antonio Metro Area and billed these federal healthcare programs for the unnecessary services.

The DOJ identified Slavisa Gasic, MD, a physician formerly employed by Dr. Rao, as a whistleblower in the investigation. When asked for comment, Oncology San Antonio alleged Dr. Gasic was “disgruntled for not being promoted.”

According to Oncology San Antonio, the contract for bone marrow biopsies was negotiated and signed by a former nonphysician officer of the company without the input of Oncology San Antonio physicians. The contract permitted bone marrow biopsies at Oncology San Antonio clinics instead of requiring older adult and sick patients to go to a different facility for these services.

“Oncology San Antonio and Rao vehemently denied Gasic’s allegations as wholly unfounded,” the company told this news organization.

Dr. Rao retired in March and is no longer practicing. CorePath Laboratories, PA, did not respond to this news organization’s request for comment.

According to the DOJ press release, the “investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud.”
 

A version of this article appeared on Medscape.com.

A San Antonio oncology practice and diagnostic reference laboratory have agreed to settle a federal lawsuit, which alleged the two entities had entered an unlawful kickback arrangement.

The US Department of Justice (DOJ) announced on April 2 that Oncology San Antonio, PA, and its physicians have agreed to pay $1.3 million, and CorePath Laboratories, PA, has agreed to pay nearly $2.75 million plus accrued interest in civil settlements with the United States and Texas for alleged violations of the False Claims Act.

According to the DOJ, the diagnostic reference laboratory, CorePath Laboratories, conducted in-office bone marrow biopsies at Oncology San Antonio practice locations and performed diagnostic testing on the samples. CorePath Laboratories agreed to pay $115 for each biopsy referred by Oncology San Antonio physicians, and these biopsy payments were allegedly paid to the private practices of three physicians at Oncology San Antonio. This arrangement allegedly began in August 2016.

The DOJ claimed that the payments for referring biopsies constituted illegal kickbacks under the Anti-Kickback Statute, which prohibits offering or receiving payments to encourage referrals of services covered by federal healthcare programs like Medicare and Medicaid.

“Violations of the Anti-Kickback Statute involving oncology services can waste scarce federal healthcare program funds and corrupt the medical decision-making process,” Special Agent in Charge Jason E. Meadows with the US Department of Health and Human Services Office of Inspector General said in a statement.

Oncology San Antonio told this news organization that the cost and distraction of prolonged litigation were the primary factors in its decision to settle. “The decision to settle was an extremely difficult one because Oncology San Antonio was confident that it would have prevailed in any action,” the practice said via email.

This civil settlement with Oncology San Antonio also resolved allegations that a physician affiliated with the practice, Jayasree Rao, MD, provided unnecessary tests, services, and treatments to patients covered by Medicare, TRICARE, and Texas Medicaid in the San Antonio Metro Area and billed these federal healthcare programs for the unnecessary services.

The DOJ identified Slavisa Gasic, MD, a physician formerly employed by Dr. Rao, as a whistleblower in the investigation. When asked for comment, Oncology San Antonio alleged Dr. Gasic was “disgruntled for not being promoted.”

According to Oncology San Antonio, the contract for bone marrow biopsies was negotiated and signed by a former nonphysician officer of the company without the input of Oncology San Antonio physicians. The contract permitted bone marrow biopsies at Oncology San Antonio clinics instead of requiring older adult and sick patients to go to a different facility for these services.

“Oncology San Antonio and Rao vehemently denied Gasic’s allegations as wholly unfounded,” the company told this news organization.

Dr. Rao retired in March and is no longer practicing. CorePath Laboratories, PA, did not respond to this news organization’s request for comment.

According to the DOJ press release, the “investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud.”
 

A version of this article appeared on Medscape.com.

TOPLINE:

Despite concerns about malpractice risk among physicians, investigators found no successful malpractice litigation related to active surveillance as a management strategy for low-risk cancers.

METHODOLOGY:

• Although practice guidelines from the National Comprehensive Cancer Network consider active surveillance an effective strategy for managing low-risk cancers, some physicians have been hesitant to incorporate it into their practice because of concerns about potential litigation.
• Researchers used Westlaw Edge and LexisNexis Advance databases to identify malpractice trends involving active surveillance related to thyroid, prostate, kidney, and  or  from 1990 to 2022.
• Data included unpublished cases, trial orders, jury verdicts, and administrative decisions.
• Researchers identified 201 malpractice cases across all low-risk cancers in the initial screening. Out of these, only five cases, all , involved active surveillance as the point of allegation.

TAKEAWAY:

• Out of the five prostate cancer cases, two involved incarcerated patients with Gleason 6 very-low-risk prostate adenocarcinoma that was managed with active surveillance by their urologists.
• In these two cases, the patients claimed that active surveillance violated their 8th Amendment right to be free from cruel or unusual punishment. In both cases, there was no metastasis or spread detected and the court determined active surveillance management was performed under national standards.
• The other three cases involved litigation claiming that active surveillance was not explicitly recommended as a treatment option for patients who all had very-low-risk prostate adenocarcinoma and had reported negligence from an intervention ( or cryoablation). However, all cases had documented informed consent for active surveillance.
• No relevant cases were found relating to active surveillance in any other type of cancer, whether in an initial diagnosis or recurrence.

IN PRACTICE:

“This data should bolster physicians’ confidence in recommending active surveillance for their patients when it is an appropriate option,” study coauthor Timothy Daskivich, MD, assistant professor of surgery at Cedars-Sinai Medical Center, Los Angeles, said in a statement . “Active surveillance maximizes quality of life and avoids unnecessary overtreatment, and it does not increase medicolegal liability to physicians, as detailed in the case dismissals identified in this study.”

SOURCE:

This study, led by Samuel Chang, JD, with Athene Law LLP, San Francisco, was recently published in Annals of Surgery.

LIMITATIONS:

The Westlaw and Lexis databases may not contain all cases or decisions issued by a state regulatory agency, like a medical board. Federal and state decisions from lower courts may not be published and available. Also, settlements outside of court or suits filed and not pursued were not included in the data.

DISCLOSURES:

The researchers did not provide any disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite concerns about malpractice risk among physicians, investigators found no successful malpractice litigation related to active surveillance as a management strategy for low-risk cancers.

METHODOLOGY:

• Although practice guidelines from the National Comprehensive Cancer Network consider active surveillance an effective strategy for managing low-risk cancers, some physicians have been hesitant to incorporate it into their practice because of concerns about potential litigation.
• Researchers used Westlaw Edge and LexisNexis Advance databases to identify malpractice trends involving active surveillance related to thyroid, prostate, kidney, and  or  from 1990 to 2022.
• Data included unpublished cases, trial orders, jury verdicts, and administrative decisions.
• Researchers identified 201 malpractice cases across all low-risk cancers in the initial screening. Out of these, only five cases, all , involved active surveillance as the point of allegation.

TAKEAWAY:

• Out of the five prostate cancer cases, two involved incarcerated patients with Gleason 6 very-low-risk prostate adenocarcinoma that was managed with active surveillance by their urologists.
• In these two cases, the patients claimed that active surveillance violated their 8th Amendment right to be free from cruel or unusual punishment. In both cases, there was no metastasis or spread detected and the court determined active surveillance management was performed under national standards.
• The other three cases involved litigation claiming that active surveillance was not explicitly recommended as a treatment option for patients who all had very-low-risk prostate adenocarcinoma and had reported negligence from an intervention ( or cryoablation). However, all cases had documented informed consent for active surveillance.
• No relevant cases were found relating to active surveillance in any other type of cancer, whether in an initial diagnosis or recurrence.

IN PRACTICE:

“This data should bolster physicians’ confidence in recommending active surveillance for their patients when it is an appropriate option,” study coauthor Timothy Daskivich, MD, assistant professor of surgery at Cedars-Sinai Medical Center, Los Angeles, said in a statement . “Active surveillance maximizes quality of life and avoids unnecessary overtreatment, and it does not increase medicolegal liability to physicians, as detailed in the case dismissals identified in this study.”

SOURCE:

This study, led by Samuel Chang, JD, with Athene Law LLP, San Francisco, was recently published in Annals of Surgery.

LIMITATIONS:

The Westlaw and Lexis databases may not contain all cases or decisions issued by a state regulatory agency, like a medical board. Federal and state decisions from lower courts may not be published and available. Also, settlements outside of court or suits filed and not pursued were not included in the data.

DISCLOSURES:

The researchers did not provide any disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Despite concerns about malpractice risk among physicians, investigators found no successful malpractice litigation related to active surveillance as a management strategy for low-risk cancers.

METHODOLOGY:

• Although practice guidelines from the National Comprehensive Cancer Network consider active surveillance an effective strategy for managing low-risk cancers, some physicians have been hesitant to incorporate it into their practice because of concerns about potential litigation.
• Researchers used Westlaw Edge and LexisNexis Advance databases to identify malpractice trends involving active surveillance related to thyroid, prostate, kidney, and  or  from 1990 to 2022.
• Data included unpublished cases, trial orders, jury verdicts, and administrative decisions.
• Researchers identified 201 malpractice cases across all low-risk cancers in the initial screening. Out of these, only five cases, all , involved active surveillance as the point of allegation.

TAKEAWAY:

• Out of the five prostate cancer cases, two involved incarcerated patients with Gleason 6 very-low-risk prostate adenocarcinoma that was managed with active surveillance by their urologists.
• In these two cases, the patients claimed that active surveillance violated their 8th Amendment right to be free from cruel or unusual punishment. In both cases, there was no metastasis or spread detected and the court determined active surveillance management was performed under national standards.
• The other three cases involved litigation claiming that active surveillance was not explicitly recommended as a treatment option for patients who all had very-low-risk prostate adenocarcinoma and had reported negligence from an intervention ( or cryoablation). However, all cases had documented informed consent for active surveillance.
• No relevant cases were found relating to active surveillance in any other type of cancer, whether in an initial diagnosis or recurrence.

IN PRACTICE:

“This data should bolster physicians’ confidence in recommending active surveillance for their patients when it is an appropriate option,” study coauthor Timothy Daskivich, MD, assistant professor of surgery at Cedars-Sinai Medical Center, Los Angeles, said in a statement . “Active surveillance maximizes quality of life and avoids unnecessary overtreatment, and it does not increase medicolegal liability to physicians, as detailed in the case dismissals identified in this study.”

SOURCE:

This study, led by Samuel Chang, JD, with Athene Law LLP, San Francisco, was recently published in Annals of Surgery.

LIMITATIONS:

The Westlaw and Lexis databases may not contain all cases or decisions issued by a state regulatory agency, like a medical board. Federal and state decisions from lower courts may not be published and available. Also, settlements outside of court or suits filed and not pursued were not included in the data.

DISCLOSURES:

The researchers did not provide any disclosures.

A version of this article appeared on Medscape.com.

The American Society for Radiation Oncology (ASTRO) recently sent a letter to the Centers for Medicare and Medicaid Services (CMS) opposing the extension of virtual supervision for radiation oncology services.

Although serious errors during virtual supervision are rare, ASTRO said radiation treatments (RT) should be done with a radiation oncologist on site to ensure high-quality care. But some radiation oncologists do not agree with the proposal to move back to direct in-person supervision only. 
 

Changes to Direct Supervision

Most radiation oncology treatments are delivered in an outpatient setting under a physician’s direction and control. 

During the COVID-19 pandemic when social distancing mandates were in place, CMS temporarily changed the definition of “direct supervision” to include telehealth, specifying that a physician must be immediately available to assist and direct a procedure virtually using real-time audio and video. In other words, a physician did not need to be physically present in the room when the treatment was being performed. 

CMS has extended this rule until the end of 2024 and is considering making it a permanent change. In the Calendar Year (CY) 2024 Medicare Physician Fee Schedule (PFS) Final Rule, CMS asked for comments on whether to extend the rule. 

“We received input from interested parties on potential patient safety or quality concerns when direct supervision occurs virtually, which we will consider for future rulemaking,” a CMS spokesperson told this news organization. “CMS is currently considering the best approach that will protect patient access and safety as well as quality of care and program integrity concerns following CY 2024.”

CMS also noted its concerns that an abrupt transition back to requiring a physician’s physical presence could interrupt care from practitioners who have established new patterns of practice with telehealth. 
 

What Are ASTRO’s Concerns?

Late last month, ASTRO sent CMS a letter, asking the agency to change the rules back to direct in-person supervision for all radiation services, citing that virtual supervision jeopardizes patient safety and quality of care. 

Jeff Michalski, MD, MBA, chair of the ASTRO Board of Directors, said in an interview that radiation oncologists should be physically present to supervise the treatments.

“ASTRO is concerned that blanket policies of general or virtual supervision could lead to patients not having direct, in-person access to their doctors’ care,” he said. “While serious errors are rare, real-world experiences of radiation oncologists across practice settings demonstrate how an in-person radiation oncology physician is best suited to ensure high-quality care.”
 

What Do Radiation Oncologists Think?

According to ASTRO, most radiation oncologists would agree that in-person supervision is best for patients. 

But that might not be the case. 

Radiation oncologists took to X (formerly Twitter) to voice their opinions about ASTRO’s letter. 

Jason Beckta, MD, PhD, of Rutland Regional’s Foley Cancer Center, Vermont, said “the February 26th ASTRO letter reads like an Onion article.” 

“I’m struggling to understand the Luddite-level myopia around this topic,” he said in another tweet. “Virtual direct/outpatient general supervision has done nothing but boost my productivity and in particular, face-to-face patient contact.”

Join Y. Luh, MD, with the Providence Medical Network in Eureka, California, said he understands the challenges faced by clinicians working in more isolated rural settings. “For them, it’s either having virtual supervision or closing the center,” Dr. Luh said.

“Virtual care is definitely at my clinic and is not only an option but is critical to my patients who are 2+ snowy, mountainous hours away,” Dr. Luh wrote. “But I’m still in the clinic directly supervising treatments.”

Sidney Roberts, MD, with the CHI St. Luke’s Health-Memorial, Texas, tweeted that supervision does require some face-to-face care but contended that “babysitting trained therapists for every routine treatment is a farce.”

Another issue Dr. Luh brought up is reimbursement for virtual supervision, noting that “the elephant in the room is whether that level of service should be reimbursed at the same rate. Reimbursement has not changed — but will it stay that way?”

ASTRO has acknowledged that radiation oncologists will have varying opinions and says it is working to balance these challenges.

CMS has not reached a decision on whether the change will be implemented permanently. The organization will assess concern, patient safety, and quality of care at the end of the year.

A version of this article first appeared on Medscape.com

The American Society for Radiation Oncology (ASTRO) recently sent a letter to the Centers for Medicare and Medicaid Services (CMS) opposing the extension of virtual supervision for radiation oncology services.

Although serious errors during virtual supervision are rare, ASTRO said radiation treatments (RT) should be done with a radiation oncologist on site to ensure high-quality care. But some radiation oncologists do not agree with the proposal to move back to direct in-person supervision only. 
 

Changes to Direct Supervision

Most radiation oncology treatments are delivered in an outpatient setting under a physician’s direction and control. 

During the COVID-19 pandemic when social distancing mandates were in place, CMS temporarily changed the definition of “direct supervision” to include telehealth, specifying that a physician must be immediately available to assist and direct a procedure virtually using real-time audio and video. In other words, a physician did not need to be physically present in the room when the treatment was being performed. 

CMS has extended this rule until the end of 2024 and is considering making it a permanent change. In the Calendar Year (CY) 2024 Medicare Physician Fee Schedule (PFS) Final Rule, CMS asked for comments on whether to extend the rule. 

“We received input from interested parties on potential patient safety or quality concerns when direct supervision occurs virtually, which we will consider for future rulemaking,” a CMS spokesperson told this news organization. “CMS is currently considering the best approach that will protect patient access and safety as well as quality of care and program integrity concerns following CY 2024.”

CMS also noted its concerns that an abrupt transition back to requiring a physician’s physical presence could interrupt care from practitioners who have established new patterns of practice with telehealth. 
 

What Are ASTRO’s Concerns?

Late last month, ASTRO sent CMS a letter, asking the agency to change the rules back to direct in-person supervision for all radiation services, citing that virtual supervision jeopardizes patient safety and quality of care. 

Jeff Michalski, MD, MBA, chair of the ASTRO Board of Directors, said in an interview that radiation oncologists should be physically present to supervise the treatments.

“ASTRO is concerned that blanket policies of general or virtual supervision could lead to patients not having direct, in-person access to their doctors’ care,” he said. “While serious errors are rare, real-world experiences of radiation oncologists across practice settings demonstrate how an in-person radiation oncology physician is best suited to ensure high-quality care.”
 

What Do Radiation Oncologists Think?

According to ASTRO, most radiation oncologists would agree that in-person supervision is best for patients. 

But that might not be the case. 

Radiation oncologists took to X (formerly Twitter) to voice their opinions about ASTRO’s letter. 

Jason Beckta, MD, PhD, of Rutland Regional’s Foley Cancer Center, Vermont, said “the February 26th ASTRO letter reads like an Onion article.” 

“I’m struggling to understand the Luddite-level myopia around this topic,” he said in another tweet. “Virtual direct/outpatient general supervision has done nothing but boost my productivity and in particular, face-to-face patient contact.”

Join Y. Luh, MD, with the Providence Medical Network in Eureka, California, said he understands the challenges faced by clinicians working in more isolated rural settings. “For them, it’s either having virtual supervision or closing the center,” Dr. Luh said.

“Virtual care is definitely at my clinic and is not only an option but is critical to my patients who are 2+ snowy, mountainous hours away,” Dr. Luh wrote. “But I’m still in the clinic directly supervising treatments.”

Sidney Roberts, MD, with the CHI St. Luke’s Health-Memorial, Texas, tweeted that supervision does require some face-to-face care but contended that “babysitting trained therapists for every routine treatment is a farce.”

Another issue Dr. Luh brought up is reimbursement for virtual supervision, noting that “the elephant in the room is whether that level of service should be reimbursed at the same rate. Reimbursement has not changed — but will it stay that way?”

ASTRO has acknowledged that radiation oncologists will have varying opinions and says it is working to balance these challenges.

CMS has not reached a decision on whether the change will be implemented permanently. The organization will assess concern, patient safety, and quality of care at the end of the year.

A version of this article first appeared on Medscape.com

The American Society for Radiation Oncology (ASTRO) recently sent a letter to the Centers for Medicare and Medicaid Services (CMS) opposing the extension of virtual supervision for radiation oncology services.

Although serious errors during virtual supervision are rare, ASTRO said radiation treatments (RT) should be done with a radiation oncologist on site to ensure high-quality care. But some radiation oncologists do not agree with the proposal to move back to direct in-person supervision only. 
 

Changes to Direct Supervision

Most radiation oncology treatments are delivered in an outpatient setting under a physician’s direction and control. 

During the COVID-19 pandemic when social distancing mandates were in place, CMS temporarily changed the definition of “direct supervision” to include telehealth, specifying that a physician must be immediately available to assist and direct a procedure virtually using real-time audio and video. In other words, a physician did not need to be physically present in the room when the treatment was being performed. 

CMS has extended this rule until the end of 2024 and is considering making it a permanent change. In the Calendar Year (CY) 2024 Medicare Physician Fee Schedule (PFS) Final Rule, CMS asked for comments on whether to extend the rule. 

“We received input from interested parties on potential patient safety or quality concerns when direct supervision occurs virtually, which we will consider for future rulemaking,” a CMS spokesperson told this news organization. “CMS is currently considering the best approach that will protect patient access and safety as well as quality of care and program integrity concerns following CY 2024.”

CMS also noted its concerns that an abrupt transition back to requiring a physician’s physical presence could interrupt care from practitioners who have established new patterns of practice with telehealth. 
 

What Are ASTRO’s Concerns?

Late last month, ASTRO sent CMS a letter, asking the agency to change the rules back to direct in-person supervision for all radiation services, citing that virtual supervision jeopardizes patient safety and quality of care. 

Jeff Michalski, MD, MBA, chair of the ASTRO Board of Directors, said in an interview that radiation oncologists should be physically present to supervise the treatments.

“ASTRO is concerned that blanket policies of general or virtual supervision could lead to patients not having direct, in-person access to their doctors’ care,” he said. “While serious errors are rare, real-world experiences of radiation oncologists across practice settings demonstrate how an in-person radiation oncology physician is best suited to ensure high-quality care.”
 

What Do Radiation Oncologists Think?

According to ASTRO, most radiation oncologists would agree that in-person supervision is best for patients. 

But that might not be the case. 

Radiation oncologists took to X (formerly Twitter) to voice their opinions about ASTRO’s letter. 

Jason Beckta, MD, PhD, of Rutland Regional’s Foley Cancer Center, Vermont, said “the February 26th ASTRO letter reads like an Onion article.” 

“I’m struggling to understand the Luddite-level myopia around this topic,” he said in another tweet. “Virtual direct/outpatient general supervision has done nothing but boost my productivity and in particular, face-to-face patient contact.”

Join Y. Luh, MD, with the Providence Medical Network in Eureka, California, said he understands the challenges faced by clinicians working in more isolated rural settings. “For them, it’s either having virtual supervision or closing the center,” Dr. Luh said.

“Virtual care is definitely at my clinic and is not only an option but is critical to my patients who are 2+ snowy, mountainous hours away,” Dr. Luh wrote. “But I’m still in the clinic directly supervising treatments.”

Sidney Roberts, MD, with the CHI St. Luke’s Health-Memorial, Texas, tweeted that supervision does require some face-to-face care but contended that “babysitting trained therapists for every routine treatment is a farce.”

Another issue Dr. Luh brought up is reimbursement for virtual supervision, noting that “the elephant in the room is whether that level of service should be reimbursed at the same rate. Reimbursement has not changed — but will it stay that way?”

ASTRO has acknowledged that radiation oncologists will have varying opinions and says it is working to balance these challenges.

CMS has not reached a decision on whether the change will be implemented permanently. The organization will assess concern, patient safety, and quality of care at the end of the year.

A version of this article first appeared on Medscape.com

An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a subsidiary of UnitedHealth, took its systems offline after a cyberattack by BlackCat/ALPHV ransomware group. 

The American Hospital Association said that this massive interruption is the “most significant cyberattack on the US healthcare system in American history.” 

What Is the Change Healthcare Attack? 

On February 21, Change Healthcare experienced an outside cybersecurity threat. When it became aware of the issue, the company disconnected its systems to prevent any further issues. Change Healthcare said that it has a “high level” of confidence that the cyberattack did not affect Optum, UnitedHealthcare, and UnitedHealth Group systems, stating it was an isolated attack on Change Healthcare. However, Change Healthcare has not said whether patient information has been compromised. 

Who Is Behind the Attack? 

In a statement, Change Healthcare announced that BlackCat/ALPHV identified itself to the company, claiming responsibility for the cybercrime. According to the US Department of Justice, BlackCat/ALPHV is the second most prolific ransomware-as-a-service entity in the world, with over 1000 victims of cybercrimes across the globe. 

This news organization reached out to the Cybersecurity and Infrastructure Security Agency (CISA), a component of the US Department of Homeland Security, for comment on whether CISA or other agencies had taken any previous action to stop the group after other attacks. 

“CISA is working with our partners and Change Healthcare to support remediation, assist impacted organizations, and share timely information to reduce the likelihood of similar intrusions,” Eric Goldstein, executive assistant director for cybersecurity, responded in a statement. 

How Has the Attack Affected Oncology Practices? 

Change Healthcare is a technology company that provides services to hospitals and clinics across the country, including pharmacy claims transactions, clinician claims processing, patient access and financial clearance, clinician payments, and prior authorizations. 

The Community Oncology Alliance (COA) said that the cyberattack has caused a massive disruption in claims processing. COA also said that practices have reported the disruption of benefits verification for patients, prior authorizations, and financial assistance from the attack. 

“It’s impacting pretty much every facet of the practice and practice management,” said Nicolas Ferreyros, managing director of policy, advocacy, and communications at COA. “Right now, practices are making do, they’re working around these challenges.” 

However, Ferreyros cautioned, continuing to manage these challenges “is absolutely, 100% unsustainable” for oncology practices.

“Very soon you’re going to find practices that are having to make tough decisions about what to do, how are they going to make payroll, are they going to take financial risks on filling prescriptions and treating patients?” he added.

What Are Current Workarounds for Clinicians? 

Change Healthcare recommends that clinicians use manual methods such as calling the payer’s provider service line to check patients’ claim status and complete eligibility verification and prior authorizations. 

The Department of Health & Human Services has issued guidance to Medicare Advantage organizations and Part D sponsors asking them to “remove or relax prior authorization, other utilization management, and timely filing requirements” while systems are offline. The department is also asking Medicare Advantage to offer advance funding to clinicians who have been affected the most.

How Common Are Attacks Like These? 

In 2023, a record-setting 725 healthcare security breaches were reported to the Department of Health & Human Services Office for Civil Rights, according to a report from The HIPAA Journal. The number of breachers has increased yearly. Last year, an average of 370,000 healthcare records were breached every day.

A version of this article first appeared on Medscape.com. 

An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a subsidiary of UnitedHealth, took its systems offline after a cyberattack by BlackCat/ALPHV ransomware group. 

The American Hospital Association said that this massive interruption is the “most significant cyberattack on the US healthcare system in American history.” 

What Is the Change Healthcare Attack? 

On February 21, Change Healthcare experienced an outside cybersecurity threat. When it became aware of the issue, the company disconnected its systems to prevent any further issues. Change Healthcare said that it has a “high level” of confidence that the cyberattack did not affect Optum, UnitedHealthcare, and UnitedHealth Group systems, stating it was an isolated attack on Change Healthcare. However, Change Healthcare has not said whether patient information has been compromised. 

Who Is Behind the Attack? 

In a statement, Change Healthcare announced that BlackCat/ALPHV identified itself to the company, claiming responsibility for the cybercrime. According to the US Department of Justice, BlackCat/ALPHV is the second most prolific ransomware-as-a-service entity in the world, with over 1000 victims of cybercrimes across the globe. 

This news organization reached out to the Cybersecurity and Infrastructure Security Agency (CISA), a component of the US Department of Homeland Security, for comment on whether CISA or other agencies had taken any previous action to stop the group after other attacks. 

“CISA is working with our partners and Change Healthcare to support remediation, assist impacted organizations, and share timely information to reduce the likelihood of similar intrusions,” Eric Goldstein, executive assistant director for cybersecurity, responded in a statement. 

How Has the Attack Affected Oncology Practices? 

Change Healthcare is a technology company that provides services to hospitals and clinics across the country, including pharmacy claims transactions, clinician claims processing, patient access and financial clearance, clinician payments, and prior authorizations. 

The Community Oncology Alliance (COA) said that the cyberattack has caused a massive disruption in claims processing. COA also said that practices have reported the disruption of benefits verification for patients, prior authorizations, and financial assistance from the attack. 

“It’s impacting pretty much every facet of the practice and practice management,” said Nicolas Ferreyros, managing director of policy, advocacy, and communications at COA. “Right now, practices are making do, they’re working around these challenges.” 

However, Ferreyros cautioned, continuing to manage these challenges “is absolutely, 100% unsustainable” for oncology practices.

“Very soon you’re going to find practices that are having to make tough decisions about what to do, how are they going to make payroll, are they going to take financial risks on filling prescriptions and treating patients?” he added.

What Are Current Workarounds for Clinicians? 

Change Healthcare recommends that clinicians use manual methods such as calling the payer’s provider service line to check patients’ claim status and complete eligibility verification and prior authorizations. 

The Department of Health & Human Services has issued guidance to Medicare Advantage organizations and Part D sponsors asking them to “remove or relax prior authorization, other utilization management, and timely filing requirements” while systems are offline. The department is also asking Medicare Advantage to offer advance funding to clinicians who have been affected the most.

How Common Are Attacks Like These? 

In 2023, a record-setting 725 healthcare security breaches were reported to the Department of Health & Human Services Office for Civil Rights, according to a report from The HIPAA Journal. The number of breachers has increased yearly. Last year, an average of 370,000 healthcare records were breached every day.

A version of this article first appeared on Medscape.com. 

An ongoing cyberattack, lasting more than 2 weeks, has had a substantial impact on cancer practices and their patients in the United States. Change Healthcare, a subsidiary of UnitedHealth, took its systems offline after a cyberattack by BlackCat/ALPHV ransomware group. 

The American Hospital Association said that this massive interruption is the “most significant cyberattack on the US healthcare system in American history.” 

What Is the Change Healthcare Attack? 

On February 21, Change Healthcare experienced an outside cybersecurity threat. When it became aware of the issue, the company disconnected its systems to prevent any further issues. Change Healthcare said that it has a “high level” of confidence that the cyberattack did not affect Optum, UnitedHealthcare, and UnitedHealth Group systems, stating it was an isolated attack on Change Healthcare. However, Change Healthcare has not said whether patient information has been compromised. 

Who Is Behind the Attack? 

In a statement, Change Healthcare announced that BlackCat/ALPHV identified itself to the company, claiming responsibility for the cybercrime. According to the US Department of Justice, BlackCat/ALPHV is the second most prolific ransomware-as-a-service entity in the world, with over 1000 victims of cybercrimes across the globe. 

This news organization reached out to the Cybersecurity and Infrastructure Security Agency (CISA), a component of the US Department of Homeland Security, for comment on whether CISA or other agencies had taken any previous action to stop the group after other attacks. 

“CISA is working with our partners and Change Healthcare to support remediation, assist impacted organizations, and share timely information to reduce the likelihood of similar intrusions,” Eric Goldstein, executive assistant director for cybersecurity, responded in a statement. 

How Has the Attack Affected Oncology Practices? 

Change Healthcare is a technology company that provides services to hospitals and clinics across the country, including pharmacy claims transactions, clinician claims processing, patient access and financial clearance, clinician payments, and prior authorizations. 

The Community Oncology Alliance (COA) said that the cyberattack has caused a massive disruption in claims processing. COA also said that practices have reported the disruption of benefits verification for patients, prior authorizations, and financial assistance from the attack. 

“It’s impacting pretty much every facet of the practice and practice management,” said Nicolas Ferreyros, managing director of policy, advocacy, and communications at COA. “Right now, practices are making do, they’re working around these challenges.” 

However, Ferreyros cautioned, continuing to manage these challenges “is absolutely, 100% unsustainable” for oncology practices.

“Very soon you’re going to find practices that are having to make tough decisions about what to do, how are they going to make payroll, are they going to take financial risks on filling prescriptions and treating patients?” he added.

What Are Current Workarounds for Clinicians? 

Change Healthcare recommends that clinicians use manual methods such as calling the payer’s provider service line to check patients’ claim status and complete eligibility verification and prior authorizations. 

The Department of Health & Human Services has issued guidance to Medicare Advantage organizations and Part D sponsors asking them to “remove or relax prior authorization, other utilization management, and timely filing requirements” while systems are offline. The department is also asking Medicare Advantage to offer advance funding to clinicians who have been affected the most.

How Common Are Attacks Like These? 

In 2023, a record-setting 725 healthcare security breaches were reported to the Department of Health & Human Services Office for Civil Rights, according to a report from The HIPAA Journal. The number of breachers has increased yearly. Last year, an average of 370,000 healthcare records were breached every day.

A version of this article first appeared on Medscape.com. 

TOPLINE:

Most older women who are colorectal cancer (CRC) survivors experience prolonged gastrointestinal (GI) symptoms many years after diagnosis and treatment, suggesting a need to improve GI symptom management in this population.

METHODOLOGY:

• In this cross-sectional study, investigators used data from the Women’s Health Initiative (WHI) Life and Longevity After Cancer study to explore the impact of cancer treatments on persistent GI symptoms in long-term female CRC survivors and why some patients suffer from these symptoms.
• The cohort consisted of 413 postmenopausal women aged 50-79 years. The mean age of the patients was 62.7 years at the time of CRC diagnosis and 71.2 years at survey completion.
• Study participants received a CRC diagnosis, mostly in the colon (n = 341), before 2011.
• Participants completed lifestyle questionnaires at baseline and annually thereafter. The questionnaires assessed a range of factors, including GI symptoms, psychological well-being, physical activity, and dietary habits.

TAKEAWAY:

• Most CRC survivors (81%) reported persistent GI symptoms more than 8 years after their cancer diagnosis.
• Abdominal bloating/gas was the most common symptom (54.2%), followed by constipation (44.1%), diarrhea (33.4%), and abdominal/pelvic pain (28.6%). Overall, 15.4% of CRC survivors reported having moderate to severe overall GI symptoms.
• Psychological distress – namely, fatigue, sleep disturbance, and anxiety – represented the most important risk factor for long-term GI symptoms. Other risk factors included time since cancer diagnosis of less than 5 years, advanced cancer stage, poor dietary habits, and low physical activity.
• GI symptoms affected survivors’ quality of life, functioning, and body image.

IN PRACTICE:

“Building upon prior work, our findings contribute to the literature by demonstrating strong relationships between GI symptoms and psychological symptoms,” the authors concluded. “Our findings shed light on the importance of psychosocial support as well as lifestyle interventions (specifically nutritional management) in managing GI symptoms in CRC survivors.”

SOURCE:

The study was led by Claire Han and was published in PLOS ONE in May 2023.

LIMITATIONS:

• The cross-sectional study design limited the researchers’ ability to identify causal effects with respect to risk factors, life impact, and GI symptoms.
• Symptom data were self-reported, so may have been underreported or overreported.

DISCLOSURES:

The study had no direct funding support. The original data collection for the WHI was funded by the National Heart, Lung, and Blood Institute. Authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Most older women who are colorectal cancer (CRC) survivors experience prolonged gastrointestinal (GI) symptoms many years after diagnosis and treatment, suggesting a need to improve GI symptom management in this population.

METHODOLOGY:

• In this cross-sectional study, investigators used data from the Women’s Health Initiative (WHI) Life and Longevity After Cancer study to explore the impact of cancer treatments on persistent GI symptoms in long-term female CRC survivors and why some patients suffer from these symptoms.
• The cohort consisted of 413 postmenopausal women aged 50-79 years. The mean age of the patients was 62.7 years at the time of CRC diagnosis and 71.2 years at survey completion.
• Study participants received a CRC diagnosis, mostly in the colon (n = 341), before 2011.
• Participants completed lifestyle questionnaires at baseline and annually thereafter. The questionnaires assessed a range of factors, including GI symptoms, psychological well-being, physical activity, and dietary habits.

TAKEAWAY:

• Most CRC survivors (81%) reported persistent GI symptoms more than 8 years after their cancer diagnosis.
• Abdominal bloating/gas was the most common symptom (54.2%), followed by constipation (44.1%), diarrhea (33.4%), and abdominal/pelvic pain (28.6%). Overall, 15.4% of CRC survivors reported having moderate to severe overall GI symptoms.
• Psychological distress – namely, fatigue, sleep disturbance, and anxiety – represented the most important risk factor for long-term GI symptoms. Other risk factors included time since cancer diagnosis of less than 5 years, advanced cancer stage, poor dietary habits, and low physical activity.
• GI symptoms affected survivors’ quality of life, functioning, and body image.

IN PRACTICE:

“Building upon prior work, our findings contribute to the literature by demonstrating strong relationships between GI symptoms and psychological symptoms,” the authors concluded. “Our findings shed light on the importance of psychosocial support as well as lifestyle interventions (specifically nutritional management) in managing GI symptoms in CRC survivors.”

SOURCE:

The study was led by Claire Han and was published in PLOS ONE in May 2023.

LIMITATIONS:

• The cross-sectional study design limited the researchers’ ability to identify causal effects with respect to risk factors, life impact, and GI symptoms.
• Symptom data were self-reported, so may have been underreported or overreported.

DISCLOSURES:

The study had no direct funding support. The original data collection for the WHI was funded by the National Heart, Lung, and Blood Institute. Authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Most older women who are colorectal cancer (CRC) survivors experience prolonged gastrointestinal (GI) symptoms many years after diagnosis and treatment, suggesting a need to improve GI symptom management in this population.

METHODOLOGY:

• In this cross-sectional study, investigators used data from the Women’s Health Initiative (WHI) Life and Longevity After Cancer study to explore the impact of cancer treatments on persistent GI symptoms in long-term female CRC survivors and why some patients suffer from these symptoms.
• The cohort consisted of 413 postmenopausal women aged 50-79 years. The mean age of the patients was 62.7 years at the time of CRC diagnosis and 71.2 years at survey completion.
• Study participants received a CRC diagnosis, mostly in the colon (n = 341), before 2011.
• Participants completed lifestyle questionnaires at baseline and annually thereafter. The questionnaires assessed a range of factors, including GI symptoms, psychological well-being, physical activity, and dietary habits.

TAKEAWAY:

• Most CRC survivors (81%) reported persistent GI symptoms more than 8 years after their cancer diagnosis.
• Abdominal bloating/gas was the most common symptom (54.2%), followed by constipation (44.1%), diarrhea (33.4%), and abdominal/pelvic pain (28.6%). Overall, 15.4% of CRC survivors reported having moderate to severe overall GI symptoms.
• Psychological distress – namely, fatigue, sleep disturbance, and anxiety – represented the most important risk factor for long-term GI symptoms. Other risk factors included time since cancer diagnosis of less than 5 years, advanced cancer stage, poor dietary habits, and low physical activity.
• GI symptoms affected survivors’ quality of life, functioning, and body image.

IN PRACTICE:

“Building upon prior work, our findings contribute to the literature by demonstrating strong relationships between GI symptoms and psychological symptoms,” the authors concluded. “Our findings shed light on the importance of psychosocial support as well as lifestyle interventions (specifically nutritional management) in managing GI symptoms in CRC survivors.”

SOURCE:

The study was led by Claire Han and was published in PLOS ONE in May 2023.

LIMITATIONS:

• The cross-sectional study design limited the researchers’ ability to identify causal effects with respect to risk factors, life impact, and GI symptoms.
• Symptom data were self-reported, so may have been underreported or overreported.

DISCLOSURES:

The study had no direct funding support. The original data collection for the WHI was funded by the National Heart, Lung, and Blood Institute. Authors have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

A version of this article first appeared on Medscape.com.

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

A version of this article first appeared on Medscape.com.

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

A version of this article first appeared on Medscape.com.

TOPLINE:

The use of oral cancer drugs on Medicare Part D formularies requiring prior authorization has increased over the past decade, with the biggest rise occurring for nonspecialty brand drugs.

METHODOLOGY:  

• Researchers used Medicare Part D formulary files to identify insurance companies’ use of prior authorization and quantity limits for each drug-dose-formulary combination for oral cancer drugs.
• Drugs were identified using the 2021 Oncology Care Model drug list.
• Researchers categorized drugs as specialty – when monthly costs were higher than $600 in 2010-2016 and $670 in 2017-2020 – or nonspecialty and brand or generic.
• For each year in the study period, which spanned 2010-2020, researchers estimated the enrollment-weighted proportion of drug-dose-formulary combinations subject to administrative burdens. 
• Medicare Part D beneficiaries increased from 28,030,290 in 2010 to 47,337,020 in 2020.

TAKEAWAYS:

• In 2010, 333 formularies covered 62 oral cancer drugs – 26 specialty brands, zero specialty generics, 28 nonspecialty brands, and eight nonspecialty generics – compared with 548 formularies and 249 drugs in 2020 – 139 specialty brands, nine specialty generics, 86 nonspecialty brands, and 15 nonspecialty generics. 
• Unique drug-dose-formulary prescribing combinations increased from 19,004 to 122,173 between 2010 and 2020; the proportion of drug-dose-formulary combinations requiring prior authorization also increased in that time.
• For specialty brand drugs, the proportion requiring prior authorization increased from 72.8% to 95.4%; that proportion increased nearly fivefold, from 15.9% to 78.2%, for nonspecialty brand drugs, and eightfold, from 1% to 8%, for nonspecialty generic drugs.
• The proportion of drug-dose-formulary combinations for oral oncology drugs requiring quantity limits for specialty brand drugs doubled over the study period – from 31.4% to 62.5%. That proportion increased from 32.7% to 77.8% for specialty generic drugs between 2016 and 2020; and between 2010 and 2020, from 11.8% to 47.3% for nonspecialty brand drugs and from 9.7% to 18.8% for nonspecialty generic drugs.

IN PRACTICE:  

“Utilization management may be appropriate for some oncology drugs, such as those approved with provisional evidence of efficacy,” researchers wrote. “It is less clear why prior authorization is required for highly effective, first-line drugs such as generic imatinib.”

SOURCE:  

The analysis, led by Michael Anne Kyle, PhD, RN, was published online July 18 in JAMA Network Open.

LIMITATIONS:

The study focused on Medicare and oral oncology drugs, and future work could expand the scope.

DISCLOSURES:

The research was funded by a National Cancer Institute grant. Coauthors received funding from Arnold Ventures and the Commonwealth Fund.

Authors reported affiliations with the Robert Wood Johnson Foundation, Leukemia & Lymphoma Society, Institute for Clinical and Economic Review, West Health, Medicare Payment Advisory Commission, National Cancer Institute, and Centers for Medicare & Medicaid Services.

A version of this article appeared on Medscape.com.

TOPLINE:

The use of oral cancer drugs on Medicare Part D formularies requiring prior authorization has increased over the past decade, with the biggest rise occurring for nonspecialty brand drugs.

METHODOLOGY:  

• Researchers used Medicare Part D formulary files to identify insurance companies’ use of prior authorization and quantity limits for each drug-dose-formulary combination for oral cancer drugs.
• Drugs were identified using the 2021 Oncology Care Model drug list.
• Researchers categorized drugs as specialty – when monthly costs were higher than $600 in 2010-2016 and $670 in 2017-2020 – or nonspecialty and brand or generic.
• For each year in the study period, which spanned 2010-2020, researchers estimated the enrollment-weighted proportion of drug-dose-formulary combinations subject to administrative burdens. 
• Medicare Part D beneficiaries increased from 28,030,290 in 2010 to 47,337,020 in 2020.

TAKEAWAYS:

• In 2010, 333 formularies covered 62 oral cancer drugs – 26 specialty brands, zero specialty generics, 28 nonspecialty brands, and eight nonspecialty generics – compared with 548 formularies and 249 drugs in 2020 – 139 specialty brands, nine specialty generics, 86 nonspecialty brands, and 15 nonspecialty generics. 
• Unique drug-dose-formulary prescribing combinations increased from 19,004 to 122,173 between 2010 and 2020; the proportion of drug-dose-formulary combinations requiring prior authorization also increased in that time.
• For specialty brand drugs, the proportion requiring prior authorization increased from 72.8% to 95.4%; that proportion increased nearly fivefold, from 15.9% to 78.2%, for nonspecialty brand drugs, and eightfold, from 1% to 8%, for nonspecialty generic drugs.
• The proportion of drug-dose-formulary combinations for oral oncology drugs requiring quantity limits for specialty brand drugs doubled over the study period – from 31.4% to 62.5%. That proportion increased from 32.7% to 77.8% for specialty generic drugs between 2016 and 2020; and between 2010 and 2020, from 11.8% to 47.3% for nonspecialty brand drugs and from 9.7% to 18.8% for nonspecialty generic drugs.

IN PRACTICE:  

“Utilization management may be appropriate for some oncology drugs, such as those approved with provisional evidence of efficacy,” researchers wrote. “It is less clear why prior authorization is required for highly effective, first-line drugs such as generic imatinib.”

SOURCE:  

The analysis, led by Michael Anne Kyle, PhD, RN, was published online July 18 in JAMA Network Open.

LIMITATIONS:

The study focused on Medicare and oral oncology drugs, and future work could expand the scope.

DISCLOSURES:

The research was funded by a National Cancer Institute grant. Coauthors received funding from Arnold Ventures and the Commonwealth Fund.

Authors reported affiliations with the Robert Wood Johnson Foundation, Leukemia & Lymphoma Society, Institute for Clinical and Economic Review, West Health, Medicare Payment Advisory Commission, National Cancer Institute, and Centers for Medicare & Medicaid Services.

A version of this article appeared on Medscape.com.

TOPLINE:

The use of oral cancer drugs on Medicare Part D formularies requiring prior authorization has increased over the past decade, with the biggest rise occurring for nonspecialty brand drugs.

METHODOLOGY:  

• Researchers used Medicare Part D formulary files to identify insurance companies’ use of prior authorization and quantity limits for each drug-dose-formulary combination for oral cancer drugs.
• Drugs were identified using the 2021 Oncology Care Model drug list.
• Researchers categorized drugs as specialty – when monthly costs were higher than $600 in 2010-2016 and $670 in 2017-2020 – or nonspecialty and brand or generic.
• For each year in the study period, which spanned 2010-2020, researchers estimated the enrollment-weighted proportion of drug-dose-formulary combinations subject to administrative burdens. 
• Medicare Part D beneficiaries increased from 28,030,290 in 2010 to 47,337,020 in 2020.

TAKEAWAYS:

• In 2010, 333 formularies covered 62 oral cancer drugs – 26 specialty brands, zero specialty generics, 28 nonspecialty brands, and eight nonspecialty generics – compared with 548 formularies and 249 drugs in 2020 – 139 specialty brands, nine specialty generics, 86 nonspecialty brands, and 15 nonspecialty generics. 
• Unique drug-dose-formulary prescribing combinations increased from 19,004 to 122,173 between 2010 and 2020; the proportion of drug-dose-formulary combinations requiring prior authorization also increased in that time.
• For specialty brand drugs, the proportion requiring prior authorization increased from 72.8% to 95.4%; that proportion increased nearly fivefold, from 15.9% to 78.2%, for nonspecialty brand drugs, and eightfold, from 1% to 8%, for nonspecialty generic drugs.
• The proportion of drug-dose-formulary combinations for oral oncology drugs requiring quantity limits for specialty brand drugs doubled over the study period – from 31.4% to 62.5%. That proportion increased from 32.7% to 77.8% for specialty generic drugs between 2016 and 2020; and between 2010 and 2020, from 11.8% to 47.3% for nonspecialty brand drugs and from 9.7% to 18.8% for nonspecialty generic drugs.

IN PRACTICE:  

“Utilization management may be appropriate for some oncology drugs, such as those approved with provisional evidence of efficacy,” researchers wrote. “It is less clear why prior authorization is required for highly effective, first-line drugs such as generic imatinib.”

SOURCE:  

The analysis, led by Michael Anne Kyle, PhD, RN, was published online July 18 in JAMA Network Open.

LIMITATIONS:

The study focused on Medicare and oral oncology drugs, and future work could expand the scope.

DISCLOSURES:

The research was funded by a National Cancer Institute grant. Coauthors received funding from Arnold Ventures and the Commonwealth Fund.

Authors reported affiliations with the Robert Wood Johnson Foundation, Leukemia & Lymphoma Society, Institute for Clinical and Economic Review, West Health, Medicare Payment Advisory Commission, National Cancer Institute, and Centers for Medicare & Medicaid Services.

A version of this article appeared on Medscape.com.

TOPLINE:

Researchers found that, prior to resection, performing a minimally invasive staging procedure on newly diagnosed patients with pancreatic cancer helped identify metastatic disease and cancer stage, and prompted a change in management in about one in five patients.

METHODOLOGY:

• The study included 1,004 patients who underwent staging laparoscopy at the Mayo Clinic, Rochester, Minn., from January 2017 to December 2021. 
• Patients’ median age was 66 years; 48% of the cohort were female. 
• Tumor location was proximal in 644 patients (64%) and distal in 360 patients (36%); median tumor size was 29 mm. 
• Upfront resectable disease was present in 351 patients (35%), and borderline resectable or locally advanced anatomy was present in 653 (65%).

TAKEAWAY:

• Overall, 180 patients had a positive staging laparoscopy because of gross metastatic disease (n = 140) and/or positive peritoneal cytology (n = 96); patients who underwent neoadjuvant chemotherapy before staging laparoscopy had lower rates of positive laparoscopy (14% vs. 22%; P = .002).
• When the analysis was restricted to chemo-naive patients who had concurrent peritoneal lavage performed, 95 of 419 patients (23%) had positive laparoscopy. 
• Among 721 patients who had a staged procedure with peritoneal washings, 151 (21%) had confirmed metastatic disease; cytology was positive in 96 (13%).
• Among patients with positive staging laparoscopy, median overall survival was 11 months in those with gross metastatic disease and 13 months in those with positive peritoneal cytology only (P = .40).

IN PRACTICE:

“Staging laparoscopy should be considered in the majority of patients prior to resection and/or initiation of neoadjuvant therapy, specifically in patients with high-risk features such as indeterminate extrapancreatic lesions on imaging, young age, large tumor size, distal tumor location, or elevated serum tumor markers,” the authors concluded. 

SOURCE:

The study, led by Hallbera Gudmundsdottir, MD, of the Mayo Clinic was published in the  Journal of the American College of Surgeons  in June. 

LIMITATIONS:

Staging laparoscopy may have been performed in higher-risk patients in earlier years of the study. The Mayo Clinic is a high-volume pancreatic surgery center that sees high-risk patients with advances lesions. This study population may not be generalizable to the those at other centers.

DISCLOSURES:

The authors did not disclose any financial interests.

A version of this article first appeared on Medscape.com.

TOPLINE:

Researchers found that, prior to resection, performing a minimally invasive staging procedure on newly diagnosed patients with pancreatic cancer helped identify metastatic disease and cancer stage, and prompted a change in management in about one in five patients.

METHODOLOGY:

• The study included 1,004 patients who underwent staging laparoscopy at the Mayo Clinic, Rochester, Minn., from January 2017 to December 2021. 
• Patients’ median age was 66 years; 48% of the cohort were female. 
• Tumor location was proximal in 644 patients (64%) and distal in 360 patients (36%); median tumor size was 29 mm. 
• Upfront resectable disease was present in 351 patients (35%), and borderline resectable or locally advanced anatomy was present in 653 (65%).

TAKEAWAY:

• Overall, 180 patients had a positive staging laparoscopy because of gross metastatic disease (n = 140) and/or positive peritoneal cytology (n = 96); patients who underwent neoadjuvant chemotherapy before staging laparoscopy had lower rates of positive laparoscopy (14% vs. 22%; P = .002).
• When the analysis was restricted to chemo-naive patients who had concurrent peritoneal lavage performed, 95 of 419 patients (23%) had positive laparoscopy. 
• Among 721 patients who had a staged procedure with peritoneal washings, 151 (21%) had confirmed metastatic disease; cytology was positive in 96 (13%).
• Among patients with positive staging laparoscopy, median overall survival was 11 months in those with gross metastatic disease and 13 months in those with positive peritoneal cytology only (P = .40).

IN PRACTICE:

“Staging laparoscopy should be considered in the majority of patients prior to resection and/or initiation of neoadjuvant therapy, specifically in patients with high-risk features such as indeterminate extrapancreatic lesions on imaging, young age, large tumor size, distal tumor location, or elevated serum tumor markers,” the authors concluded. 

SOURCE:

The study, led by Hallbera Gudmundsdottir, MD, of the Mayo Clinic was published in the  Journal of the American College of Surgeons  in June. 

LIMITATIONS:

Staging laparoscopy may have been performed in higher-risk patients in earlier years of the study. The Mayo Clinic is a high-volume pancreatic surgery center that sees high-risk patients with advances lesions. This study population may not be generalizable to the those at other centers.

DISCLOSURES:

The authors did not disclose any financial interests.

A version of this article first appeared on Medscape.com.

TOPLINE:

Researchers found that, prior to resection, performing a minimally invasive staging procedure on newly diagnosed patients with pancreatic cancer helped identify metastatic disease and cancer stage, and prompted a change in management in about one in five patients.

METHODOLOGY:

• The study included 1,004 patients who underwent staging laparoscopy at the Mayo Clinic, Rochester, Minn., from January 2017 to December 2021. 
• Patients’ median age was 66 years; 48% of the cohort were female. 
• Tumor location was proximal in 644 patients (64%) and distal in 360 patients (36%); median tumor size was 29 mm. 
• Upfront resectable disease was present in 351 patients (35%), and borderline resectable or locally advanced anatomy was present in 653 (65%).

TAKEAWAY:

• Overall, 180 patients had a positive staging laparoscopy because of gross metastatic disease (n = 140) and/or positive peritoneal cytology (n = 96); patients who underwent neoadjuvant chemotherapy before staging laparoscopy had lower rates of positive laparoscopy (14% vs. 22%; P = .002).
• When the analysis was restricted to chemo-naive patients who had concurrent peritoneal lavage performed, 95 of 419 patients (23%) had positive laparoscopy. 
• Among 721 patients who had a staged procedure with peritoneal washings, 151 (21%) had confirmed metastatic disease; cytology was positive in 96 (13%).
• Among patients with positive staging laparoscopy, median overall survival was 11 months in those with gross metastatic disease and 13 months in those with positive peritoneal cytology only (P = .40).

IN PRACTICE:

“Staging laparoscopy should be considered in the majority of patients prior to resection and/or initiation of neoadjuvant therapy, specifically in patients with high-risk features such as indeterminate extrapancreatic lesions on imaging, young age, large tumor size, distal tumor location, or elevated serum tumor markers,” the authors concluded. 

SOURCE:

The study, led by Hallbera Gudmundsdottir, MD, of the Mayo Clinic was published in the  Journal of the American College of Surgeons  in June. 

LIMITATIONS:

Staging laparoscopy may have been performed in higher-risk patients in earlier years of the study. The Mayo Clinic is a high-volume pancreatic surgery center that sees high-risk patients with advances lesions. This study population may not be generalizable to the those at other centers.

DISCLOSURES:

The authors did not disclose any financial interests.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration recently released final guidance on a voluntary pilot program to help reduce the risks associated with certain diagnostic biomarker tests used to guide cancer treatment decisions for patients.

These laboratory-developed tests were designed to detect cancer biomarkers to help clinicians find the most appropriate cancer treatments for their patients. But the agency explained it has “become increasingly concerned that some tests made by laboratories and not authorized by the FDA may not provide accurate and reliable test results or perform as well as FDA-authorized tests.”

Currently, in most circumstances, an in vitro companion diagnostic would be granted marketing authorization alongside the approval of a corresponding cancer therapy. Under limited circumstances, however, the FDA may decide to approve a cancer therapy that requires a diagnostic test, which has not yet received marketing authorization. In these instances, “the benefits from the use of the therapeutic product are so pronounced as to outweigh the risks from the lack of an [in vitro companion diagnostic] with marketing authorization,” the FDA explained in 2014 in a guidance titled, In Vitro Companion Diagnostic Devices .

The new pilot program now aims to “address concerns and questions around the use of unauthorized diagnostics” and help improve cancer care for patients, Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press announcement.

The voluntary program will seek to provide greater transparency surrounding performance recommendations for these diagnostic tests. More specifically, the FDA will ask drug manufacturers to provide performance information for tests used to enroll patients in clinical trials that support drug approval. The agency will assess the performance information and establish the minimum performance criteria recommended for similar tests used to select cancer treatments for patients. The results, posted to the FDA’s website, may be used by laboratories to guide their development of diagnostic tests.

The FDA plans to evaluate no more than nine drug sponsors for the pilot program. This initial phase of the program is anticipated to last up to a year.

“We believe this guidance and the launch of the pilot program are important steps toward addressing safety risks posed by the use of poorly performing laboratory developed tests,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration recently released final guidance on a voluntary pilot program to help reduce the risks associated with certain diagnostic biomarker tests used to guide cancer treatment decisions for patients.

These laboratory-developed tests were designed to detect cancer biomarkers to help clinicians find the most appropriate cancer treatments for their patients. But the agency explained it has “become increasingly concerned that some tests made by laboratories and not authorized by the FDA may not provide accurate and reliable test results or perform as well as FDA-authorized tests.”

Currently, in most circumstances, an in vitro companion diagnostic would be granted marketing authorization alongside the approval of a corresponding cancer therapy. Under limited circumstances, however, the FDA may decide to approve a cancer therapy that requires a diagnostic test, which has not yet received marketing authorization. In these instances, “the benefits from the use of the therapeutic product are so pronounced as to outweigh the risks from the lack of an [in vitro companion diagnostic] with marketing authorization,” the FDA explained in 2014 in a guidance titled, In Vitro Companion Diagnostic Devices .

The new pilot program now aims to “address concerns and questions around the use of unauthorized diagnostics” and help improve cancer care for patients, Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press announcement.

The voluntary program will seek to provide greater transparency surrounding performance recommendations for these diagnostic tests. More specifically, the FDA will ask drug manufacturers to provide performance information for tests used to enroll patients in clinical trials that support drug approval. The agency will assess the performance information and establish the minimum performance criteria recommended for similar tests used to select cancer treatments for patients. The results, posted to the FDA’s website, may be used by laboratories to guide their development of diagnostic tests.

The FDA plans to evaluate no more than nine drug sponsors for the pilot program. This initial phase of the program is anticipated to last up to a year.

“We believe this guidance and the launch of the pilot program are important steps toward addressing safety risks posed by the use of poorly performing laboratory developed tests,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration recently released final guidance on a voluntary pilot program to help reduce the risks associated with certain diagnostic biomarker tests used to guide cancer treatment decisions for patients.

These laboratory-developed tests were designed to detect cancer biomarkers to help clinicians find the most appropriate cancer treatments for their patients. But the agency explained it has “become increasingly concerned that some tests made by laboratories and not authorized by the FDA may not provide accurate and reliable test results or perform as well as FDA-authorized tests.”

Currently, in most circumstances, an in vitro companion diagnostic would be granted marketing authorization alongside the approval of a corresponding cancer therapy. Under limited circumstances, however, the FDA may decide to approve a cancer therapy that requires a diagnostic test, which has not yet received marketing authorization. In these instances, “the benefits from the use of the therapeutic product are so pronounced as to outweigh the risks from the lack of an [in vitro companion diagnostic] with marketing authorization,” the FDA explained in 2014 in a guidance titled, In Vitro Companion Diagnostic Devices .

The new pilot program now aims to “address concerns and questions around the use of unauthorized diagnostics” and help improve cancer care for patients, Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press announcement.

The voluntary program will seek to provide greater transparency surrounding performance recommendations for these diagnostic tests. More specifically, the FDA will ask drug manufacturers to provide performance information for tests used to enroll patients in clinical trials that support drug approval. The agency will assess the performance information and establish the minimum performance criteria recommended for similar tests used to select cancer treatments for patients. The results, posted to the FDA’s website, may be used by laboratories to guide their development of diagnostic tests.

The FDA plans to evaluate no more than nine drug sponsors for the pilot program. This initial phase of the program is anticipated to last up to a year.

“We believe this guidance and the launch of the pilot program are important steps toward addressing safety risks posed by the use of poorly performing laboratory developed tests,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

A version of this article first appeared on Medscape.com.

Oncology fellows who completed diversity, equity, and inclusion (DEI) training report that they feel more confident about responding to different types of discrimination, both when directed at them personally and when directed at others.

The finding comes from a survey conducted after the introduction of DEI training within the Yale Medical Oncology-Hematology Fellowship Program. The study was reported by Norin Ansari, MD, MPH, of Yale Cancer Center, New Haven, Conn., at the annual meeting of the American Society of Clinical Oncology (ASCO).

Dr. Ansari emphasized the DEI curriculum in fellowship programs by highlighting the racial and gender disparities that exist among physicians.

“There is a significant representation problem – only 2%-3% of practicing oncologists are Black or Hispanic/Latino,” she said. “And that representation decreases with each stage in the pipeline of the workforce.”

Dr. Ansari also noted gender disparities in the oncologist workforce, reporting that about one-third of faculty positions are held by women.

The anonymous survey was sent to 29 fellows; 23 responded, including 8 first-year fellows and 13 senior fellows. Over 57% of respondents rated the importance of DEI education as 10 on a 10-point scale (mean, 8.6).

At the start of this year, the responses of senior fellows who had already received some DEI training during the previous year’s lecture series were compared with first-year fellows who had not had any fellowship DEI education.

First-year fellows reported a mean confidence score of 2.5/5 at navigating bias and microaggressions when experienced personally and a mean score of 2.9/5 when they were directed at others. Senior fellows reported mean confidence scores of 3 and 3.2, respectively.

Yale then compared longitudinal data on fellows’ comfort levels in navigating discrimination in 2021, 2022, and 2023 a month before the ASCO meeting.

Fellows were asked to rate their comfort level from 1 to 10 in navigating different types of discrimination, including racial inequality, sexual harassment, and gender discrimination. In these three categories, fellows rated comfortability as a 5 in 2021 and as 7 in 2023 after the DEI training.

“Our first goal is to normalize talking about DEI and to recognize that different people in our workforce have different experiences and how we can be allies for them and for our patients,” Dr. Ansari said. “And I think for long-term goals we want to take stock of who’s at the table, who’s making decisions, and how does that affect our field, our science, and our patients.”

Yale designed the 3-year longitudinal curriculum with two annual core topics: upstander training and journal club for discussion and reflection. An additional two to three training sessions per year will focus on either race, gender, LGBTQ+, disability, religion, or implicit bias training.

The most popular topics among fellows were upstander training, cancer treatment and outcomes disparities, recruitment and retention, and career promotion and pay disparities.

The preferred platforms of content delivery were lectures from experts in the field, affinity groups or mentorship links, small group discussions, and advocacy education.

Gerald Hsu, MD, PhD, with the San Francisco VA Medical Center, discussed the results of Yale’s DEI curriculum assessment, saying it represented “best practices” in the industry. However, he acknowledged that realistically, not everyone will be receptive to DEI training.

Dr. Hsu said that holding medical staff accountable is the only way to truly incorporate DEI into everyday practice.

“Collectively, we need to be holding ourselves to different standards or holding ourselves to some standard,” Dr. Hsu said. “Maybe we need to be setting goals to the degree to which we diversify our training programs and our faculty, and there needs to be consequences to not doing so.”

No funding for the study was reported.

A version of this article first appeared on Medscape.com.

Oncology fellows who completed diversity, equity, and inclusion (DEI) training report that they feel more confident about responding to different types of discrimination, both when directed at them personally and when directed at others.

The finding comes from a survey conducted after the introduction of DEI training within the Yale Medical Oncology-Hematology Fellowship Program. The study was reported by Norin Ansari, MD, MPH, of Yale Cancer Center, New Haven, Conn., at the annual meeting of the American Society of Clinical Oncology (ASCO).

Dr. Ansari emphasized the DEI curriculum in fellowship programs by highlighting the racial and gender disparities that exist among physicians.

“There is a significant representation problem – only 2%-3% of practicing oncologists are Black or Hispanic/Latino,” she said. “And that representation decreases with each stage in the pipeline of the workforce.”

Dr. Ansari also noted gender disparities in the oncologist workforce, reporting that about one-third of faculty positions are held by women.

The anonymous survey was sent to 29 fellows; 23 responded, including 8 first-year fellows and 13 senior fellows. Over 57% of respondents rated the importance of DEI education as 10 on a 10-point scale (mean, 8.6).

At the start of this year, the responses of senior fellows who had already received some DEI training during the previous year’s lecture series were compared with first-year fellows who had not had any fellowship DEI education.

First-year fellows reported a mean confidence score of 2.5/5 at navigating bias and microaggressions when experienced personally and a mean score of 2.9/5 when they were directed at others. Senior fellows reported mean confidence scores of 3 and 3.2, respectively.

Yale then compared longitudinal data on fellows’ comfort levels in navigating discrimination in 2021, 2022, and 2023 a month before the ASCO meeting.

Fellows were asked to rate their comfort level from 1 to 10 in navigating different types of discrimination, including racial inequality, sexual harassment, and gender discrimination. In these three categories, fellows rated comfortability as a 5 in 2021 and as 7 in 2023 after the DEI training.

“Our first goal is to normalize talking about DEI and to recognize that different people in our workforce have different experiences and how we can be allies for them and for our patients,” Dr. Ansari said. “And I think for long-term goals we want to take stock of who’s at the table, who’s making decisions, and how does that affect our field, our science, and our patients.”

Yale designed the 3-year longitudinal curriculum with two annual core topics: upstander training and journal club for discussion and reflection. An additional two to three training sessions per year will focus on either race, gender, LGBTQ+, disability, religion, or implicit bias training.

The most popular topics among fellows were upstander training, cancer treatment and outcomes disparities, recruitment and retention, and career promotion and pay disparities.

The preferred platforms of content delivery were lectures from experts in the field, affinity groups or mentorship links, small group discussions, and advocacy education.

Gerald Hsu, MD, PhD, with the San Francisco VA Medical Center, discussed the results of Yale’s DEI curriculum assessment, saying it represented “best practices” in the industry. However, he acknowledged that realistically, not everyone will be receptive to DEI training.

Dr. Hsu said that holding medical staff accountable is the only way to truly incorporate DEI into everyday practice.

“Collectively, we need to be holding ourselves to different standards or holding ourselves to some standard,” Dr. Hsu said. “Maybe we need to be setting goals to the degree to which we diversify our training programs and our faculty, and there needs to be consequences to not doing so.”

No funding for the study was reported.

A version of this article first appeared on Medscape.com.

Oncology fellows who completed diversity, equity, and inclusion (DEI) training report that they feel more confident about responding to different types of discrimination, both when directed at them personally and when directed at others.

The finding comes from a survey conducted after the introduction of DEI training within the Yale Medical Oncology-Hematology Fellowship Program. The study was reported by Norin Ansari, MD, MPH, of Yale Cancer Center, New Haven, Conn., at the annual meeting of the American Society of Clinical Oncology (ASCO).

Dr. Ansari emphasized the DEI curriculum in fellowship programs by highlighting the racial and gender disparities that exist among physicians.

“There is a significant representation problem – only 2%-3% of practicing oncologists are Black or Hispanic/Latino,” she said. “And that representation decreases with each stage in the pipeline of the workforce.”

Dr. Ansari also noted gender disparities in the oncologist workforce, reporting that about one-third of faculty positions are held by women.

The anonymous survey was sent to 29 fellows; 23 responded, including 8 first-year fellows and 13 senior fellows. Over 57% of respondents rated the importance of DEI education as 10 on a 10-point scale (mean, 8.6).

At the start of this year, the responses of senior fellows who had already received some DEI training during the previous year’s lecture series were compared with first-year fellows who had not had any fellowship DEI education.

First-year fellows reported a mean confidence score of 2.5/5 at navigating bias and microaggressions when experienced personally and a mean score of 2.9/5 when they were directed at others. Senior fellows reported mean confidence scores of 3 and 3.2, respectively.

Yale then compared longitudinal data on fellows’ comfort levels in navigating discrimination in 2021, 2022, and 2023 a month before the ASCO meeting.

Fellows were asked to rate their comfort level from 1 to 10 in navigating different types of discrimination, including racial inequality, sexual harassment, and gender discrimination. In these three categories, fellows rated comfortability as a 5 in 2021 and as 7 in 2023 after the DEI training.

“Our first goal is to normalize talking about DEI and to recognize that different people in our workforce have different experiences and how we can be allies for them and for our patients,” Dr. Ansari said. “And I think for long-term goals we want to take stock of who’s at the table, who’s making decisions, and how does that affect our field, our science, and our patients.”

Yale designed the 3-year longitudinal curriculum with two annual core topics: upstander training and journal club for discussion and reflection. An additional two to three training sessions per year will focus on either race, gender, LGBTQ+, disability, religion, or implicit bias training.

The most popular topics among fellows were upstander training, cancer treatment and outcomes disparities, recruitment and retention, and career promotion and pay disparities.

The preferred platforms of content delivery were lectures from experts in the field, affinity groups or mentorship links, small group discussions, and advocacy education.

Gerald Hsu, MD, PhD, with the San Francisco VA Medical Center, discussed the results of Yale’s DEI curriculum assessment, saying it represented “best practices” in the industry. However, he acknowledged that realistically, not everyone will be receptive to DEI training.

Dr. Hsu said that holding medical staff accountable is the only way to truly incorporate DEI into everyday practice.

“Collectively, we need to be holding ourselves to different standards or holding ourselves to some standard,” Dr. Hsu said. “Maybe we need to be setting goals to the degree to which we diversify our training programs and our faculty, and there needs to be consequences to not doing so.”

No funding for the study was reported.

A version of this article first appeared on Medscape.com.