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Cancer Drug Shortages Continue in the US, Survey Finds
Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.
“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.
The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.
“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.
However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.
“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.
In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.
Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).
In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.
In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.
Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.
How are centers dealing with ongoing supply issues?
Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.
“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.
Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.
The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.
“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”
A version of this article appeared on Medscape.com.
Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.
“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.
The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.
“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.
However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.
“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.
In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.
Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).
In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.
In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.
Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.
How are centers dealing with ongoing supply issues?
Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.
“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.
Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.
The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.
“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”
A version of this article appeared on Medscape.com.
Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.
“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.
The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.
“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.
However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.
“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.
In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.
Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).
In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.
In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.
Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.
How are centers dealing with ongoing supply issues?
Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.
“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.
Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.
The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.
“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”
A version of this article appeared on Medscape.com.
Study Finds Variations in Pediatric Dermatologists Who Accept Medicaid
TOPLINE:
METHODOLOGY:
- Researchers identified 352 actively practicing board-certified pediatric dermatologists using the Society for Pediatric Dermatology database and determined Medicaid acceptance status.
- They collected physician and practice characteristics from the US Census American Community Survey data and a web search.
TAKEAWAY:
- A total of 275 (78.1%) board-certified pediatric dermatologists accepted Medicaid.
- Academic practices had the highest Medicaid acceptance rate (98.7%), while private practices had the lowest (43.1%), a significant difference (P < .001).
- Acceptance rates were significantly higher in the Midwest (90.9%) than in the Northeast (71.8%) or West (71.4%; P = .005). Regional differences persisted after controlling for practice type: Midwest practice locations had greater odds of Medicaid acceptance than those in the Northeast (odds ratio [OR], 5.25; 95% confidence interval [CI], 1.76-15.65) or West (OR, 5.26; 95% CI, 1.88-14.66).
- Practices in counties with lower median household incomes and greater densities of pediatric dermatologists were associated with higher Medicaid acceptance (P = .001).
IN PRACTICE:
“While most pediatric dermatologists accept Medicaid, this study revealed differential access to care based on practice type, geographic location, and density of pediatric dermatologists per county,” the authors wrote. More research is needed on “the impact on health outcomes when specialty services are unavailable” and on “the role of administrative and reimbursement barriers limiting Medicaid acceptance among pediatric dermatologists,” they added.
SOURCE:
The study was led by Madeleine Tessier-Kay, MPH, Department of Dermatology, at the University of Connecticut Health Center in Farmington, Connecticut. It was published online in Pediatric Dermatology.
LIMITATIONS:
Limitations include potential incomplete capture of board-certified physicians, as not all board-certified pediatric dermatologists may be members of the Society for Pediatric Dermatology, and potential inaccurate capture of physician characteristics and Medicaid acceptance status.
DISCLOSURES:
The study funding source was not disclosed. One author was a consultant for AbbVie. Other authors declared no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers identified 352 actively practicing board-certified pediatric dermatologists using the Society for Pediatric Dermatology database and determined Medicaid acceptance status.
- They collected physician and practice characteristics from the US Census American Community Survey data and a web search.
TAKEAWAY:
- A total of 275 (78.1%) board-certified pediatric dermatologists accepted Medicaid.
- Academic practices had the highest Medicaid acceptance rate (98.7%), while private practices had the lowest (43.1%), a significant difference (P < .001).
- Acceptance rates were significantly higher in the Midwest (90.9%) than in the Northeast (71.8%) or West (71.4%; P = .005). Regional differences persisted after controlling for practice type: Midwest practice locations had greater odds of Medicaid acceptance than those in the Northeast (odds ratio [OR], 5.25; 95% confidence interval [CI], 1.76-15.65) or West (OR, 5.26; 95% CI, 1.88-14.66).
- Practices in counties with lower median household incomes and greater densities of pediatric dermatologists were associated with higher Medicaid acceptance (P = .001).
IN PRACTICE:
“While most pediatric dermatologists accept Medicaid, this study revealed differential access to care based on practice type, geographic location, and density of pediatric dermatologists per county,” the authors wrote. More research is needed on “the impact on health outcomes when specialty services are unavailable” and on “the role of administrative and reimbursement barriers limiting Medicaid acceptance among pediatric dermatologists,” they added.
SOURCE:
The study was led by Madeleine Tessier-Kay, MPH, Department of Dermatology, at the University of Connecticut Health Center in Farmington, Connecticut. It was published online in Pediatric Dermatology.
LIMITATIONS:
Limitations include potential incomplete capture of board-certified physicians, as not all board-certified pediatric dermatologists may be members of the Society for Pediatric Dermatology, and potential inaccurate capture of physician characteristics and Medicaid acceptance status.
DISCLOSURES:
The study funding source was not disclosed. One author was a consultant for AbbVie. Other authors declared no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers identified 352 actively practicing board-certified pediatric dermatologists using the Society for Pediatric Dermatology database and determined Medicaid acceptance status.
- They collected physician and practice characteristics from the US Census American Community Survey data and a web search.
TAKEAWAY:
- A total of 275 (78.1%) board-certified pediatric dermatologists accepted Medicaid.
- Academic practices had the highest Medicaid acceptance rate (98.7%), while private practices had the lowest (43.1%), a significant difference (P < .001).
- Acceptance rates were significantly higher in the Midwest (90.9%) than in the Northeast (71.8%) or West (71.4%; P = .005). Regional differences persisted after controlling for practice type: Midwest practice locations had greater odds of Medicaid acceptance than those in the Northeast (odds ratio [OR], 5.25; 95% confidence interval [CI], 1.76-15.65) or West (OR, 5.26; 95% CI, 1.88-14.66).
- Practices in counties with lower median household incomes and greater densities of pediatric dermatologists were associated with higher Medicaid acceptance (P = .001).
IN PRACTICE:
“While most pediatric dermatologists accept Medicaid, this study revealed differential access to care based on practice type, geographic location, and density of pediatric dermatologists per county,” the authors wrote. More research is needed on “the impact on health outcomes when specialty services are unavailable” and on “the role of administrative and reimbursement barriers limiting Medicaid acceptance among pediatric dermatologists,” they added.
SOURCE:
The study was led by Madeleine Tessier-Kay, MPH, Department of Dermatology, at the University of Connecticut Health Center in Farmington, Connecticut. It was published online in Pediatric Dermatology.
LIMITATIONS:
Limitations include potential incomplete capture of board-certified physicians, as not all board-certified pediatric dermatologists may be members of the Society for Pediatric Dermatology, and potential inaccurate capture of physician characteristics and Medicaid acceptance status.
DISCLOSURES:
The study funding source was not disclosed. One author was a consultant for AbbVie. Other authors declared no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Supreme Court Ruling Overturning Chevron Could ‘Paralyze’ Health Policy Making: Experts
Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, wrote on X, “my worry is that it will paralyze policymaking in healthcare and other areas,” because “Congress will try to fill in more details, making it harder to pass legislation.” He also wrote that federal agencies “will become very cautious in using their regulatory authority.”
In their 6-3 opinion reversing the “Chevron doctrine” — which has been followed since a 1984 Court opinion — the Justices said that the judiciary should no longer have to defer to federal agency interpretations of laws. Existing federal law “requires courts to exercise their independent judgment in deciding whether an agency has acted within its statutory authority,” said the Court, in stating why Chevron should be overruled.
Writing for the majority in the combined cases — Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo — Chief Justice John Roberts Jr. wrote that “agencies have no special competence in resolving statutory ambiguities. Courts do.”
In a dissenting opinion, Justice Elena Kagan said the decision was a judicial power grab and would result in a “jolt to the legal system.” She was joined by Justices Sonia Sotomayor and Ketanji Brown Jackson.
The opinion will have many repercussions, said lawyer and Supreme Court watcher Amy Howe. The Chevron ruling has been “one of the most important rulings on federal administrative law, cited by federal courts more than 18,000 times,” she wrote on her blog.
For example, without the long-standing deference to agencies under Chevron, healthcare providers may have more opportunities to challenge how federal officials set Medicare reimbursement for hospital procedures or prescription drugs, Baker Donelson healthcare attorneys McKenna Cloud and Thomas Barnard wrote in an analysis.
Seventeen health organizations issued a joint statement signaling their disappointment.
“We anticipate that today’s ruling will cause significant disruption to publicly funded health insurance programs, to the stability of this country’s healthcare and food and drug review systems, and to the health and well-being of the patients and consumers we serve,” wrote the organizations, which included American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, ALS Association, American Heart Association, American Lung Association, American Public Health Association, American Thoracic Society, Bazelon Center for Mental Health Law, Campaign for Tobacco-Free Kids, Child Neurology Foundation, Epilepsy Foundation, Muscular Dystrophy Association, National Health Law Program, Physicians for Social Responsibility, The Leukemia & Lymphoma Society, and Truth Initiative.
“It’s much harder for agencies to exercise power without some power to interpret statues. This is big,” wrote Berkeley Law Professor Orin Kerr on X.
A New, Uncertain Landscape for Healthcare
In the original Chevron case, the Court ruled that federal agencies had relevant expertise and should be given deference in resolving ambiguities that Congress had not spelled out in legislation.
In Relentless and Loper Bright, the plaintiffs argued that federal agencies overstepped their authority by issuing a rule that required commercial fishing vessels to pay for professional observers to monitor their catch.
In a statement after Friday’s ruling, the Relentless plaintiffs’ attorneys said that the decision “will recalibrate the balance of power between agencies and courts” and “make it harder for those agencies to adopt regulatory programs that exceed the authority conferred on them by Congress.”
Some predicted chaos in the wake of the ruling.
“Overturning Chevron could invite legal challenges to any and all agency determinations of ambiguous statutes by any stakeholder, leaving individual courts with the impractical task of determining the ‘correct’ meaning of statutes without the benefit of requisite expertise, practical experience, or public engagement,” wrote Sahil Agrawal, MD, PhD, Joseph S. Ross, MD, and Reshma Ramachandran, MD, in JAMA in an opinion piece in March that considered the ramifications of overturning Chevron.
“The spillover effects for medicine and public health, in turn, will be consequential,” they wrote.
In an analysis published in April, the Kaiser Family Foundation noted many potential ramifications on patient and consumer protections in the health insurance market. For instance, courts could vacate current rules governing protections under the Affordable Care Act, including that health plans offer a range of free preventive health services, such as breast, cervical, colon, and lung cancer screening.
Congressional, White House Reaction
Many legal observers said the ruling will have the effect of requiring Congress to write ever-more dense and exacting legislation to prevent agencies from interpreting any gaps.
Some members of Congress welcomed the decision.
Senate Minority Leader Mitch McConnell (R-Kentucky) said in a statement, “The Constitution vests Congress with the sole authority to make law,” adding, “the Supreme Court made it clear today that our system of government leaves no room for an unelected bureaucracy to co-opt this authority for itself.”
In a post on X, Senate Majority Leader Chuck Schumer (D-New York) accused the Court of siding with “special interests and giant corporations.” Added Mr. Schumer, “Their headlong rush to overturn 40 years of precedent and impose their own radical views is appalling.”
White House Press Secretary Karine Jean-Pierre said in a statement that “While this decision undermines the ability of federal agencies to use their expertise as Congress intended to make government work for the people, the Biden-Harris Administration will not relent in our efforts to protect and serve every American.”
A version of this article first appeared on Medscape.com.
Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, wrote on X, “my worry is that it will paralyze policymaking in healthcare and other areas,” because “Congress will try to fill in more details, making it harder to pass legislation.” He also wrote that federal agencies “will become very cautious in using their regulatory authority.”
In their 6-3 opinion reversing the “Chevron doctrine” — which has been followed since a 1984 Court opinion — the Justices said that the judiciary should no longer have to defer to federal agency interpretations of laws. Existing federal law “requires courts to exercise their independent judgment in deciding whether an agency has acted within its statutory authority,” said the Court, in stating why Chevron should be overruled.
Writing for the majority in the combined cases — Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo — Chief Justice John Roberts Jr. wrote that “agencies have no special competence in resolving statutory ambiguities. Courts do.”
In a dissenting opinion, Justice Elena Kagan said the decision was a judicial power grab and would result in a “jolt to the legal system.” She was joined by Justices Sonia Sotomayor and Ketanji Brown Jackson.
The opinion will have many repercussions, said lawyer and Supreme Court watcher Amy Howe. The Chevron ruling has been “one of the most important rulings on federal administrative law, cited by federal courts more than 18,000 times,” she wrote on her blog.
For example, without the long-standing deference to agencies under Chevron, healthcare providers may have more opportunities to challenge how federal officials set Medicare reimbursement for hospital procedures or prescription drugs, Baker Donelson healthcare attorneys McKenna Cloud and Thomas Barnard wrote in an analysis.
Seventeen health organizations issued a joint statement signaling their disappointment.
“We anticipate that today’s ruling will cause significant disruption to publicly funded health insurance programs, to the stability of this country’s healthcare and food and drug review systems, and to the health and well-being of the patients and consumers we serve,” wrote the organizations, which included American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, ALS Association, American Heart Association, American Lung Association, American Public Health Association, American Thoracic Society, Bazelon Center for Mental Health Law, Campaign for Tobacco-Free Kids, Child Neurology Foundation, Epilepsy Foundation, Muscular Dystrophy Association, National Health Law Program, Physicians for Social Responsibility, The Leukemia & Lymphoma Society, and Truth Initiative.
“It’s much harder for agencies to exercise power without some power to interpret statues. This is big,” wrote Berkeley Law Professor Orin Kerr on X.
A New, Uncertain Landscape for Healthcare
In the original Chevron case, the Court ruled that federal agencies had relevant expertise and should be given deference in resolving ambiguities that Congress had not spelled out in legislation.
In Relentless and Loper Bright, the plaintiffs argued that federal agencies overstepped their authority by issuing a rule that required commercial fishing vessels to pay for professional observers to monitor their catch.
In a statement after Friday’s ruling, the Relentless plaintiffs’ attorneys said that the decision “will recalibrate the balance of power between agencies and courts” and “make it harder for those agencies to adopt regulatory programs that exceed the authority conferred on them by Congress.”
Some predicted chaos in the wake of the ruling.
“Overturning Chevron could invite legal challenges to any and all agency determinations of ambiguous statutes by any stakeholder, leaving individual courts with the impractical task of determining the ‘correct’ meaning of statutes without the benefit of requisite expertise, practical experience, or public engagement,” wrote Sahil Agrawal, MD, PhD, Joseph S. Ross, MD, and Reshma Ramachandran, MD, in JAMA in an opinion piece in March that considered the ramifications of overturning Chevron.
“The spillover effects for medicine and public health, in turn, will be consequential,” they wrote.
In an analysis published in April, the Kaiser Family Foundation noted many potential ramifications on patient and consumer protections in the health insurance market. For instance, courts could vacate current rules governing protections under the Affordable Care Act, including that health plans offer a range of free preventive health services, such as breast, cervical, colon, and lung cancer screening.
Congressional, White House Reaction
Many legal observers said the ruling will have the effect of requiring Congress to write ever-more dense and exacting legislation to prevent agencies from interpreting any gaps.
Some members of Congress welcomed the decision.
Senate Minority Leader Mitch McConnell (R-Kentucky) said in a statement, “The Constitution vests Congress with the sole authority to make law,” adding, “the Supreme Court made it clear today that our system of government leaves no room for an unelected bureaucracy to co-opt this authority for itself.”
In a post on X, Senate Majority Leader Chuck Schumer (D-New York) accused the Court of siding with “special interests and giant corporations.” Added Mr. Schumer, “Their headlong rush to overturn 40 years of precedent and impose their own radical views is appalling.”
White House Press Secretary Karine Jean-Pierre said in a statement that “While this decision undermines the ability of federal agencies to use their expertise as Congress intended to make government work for the people, the Biden-Harris Administration will not relent in our efforts to protect and serve every American.”
A version of this article first appeared on Medscape.com.
Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation, wrote on X, “my worry is that it will paralyze policymaking in healthcare and other areas,” because “Congress will try to fill in more details, making it harder to pass legislation.” He also wrote that federal agencies “will become very cautious in using their regulatory authority.”
In their 6-3 opinion reversing the “Chevron doctrine” — which has been followed since a 1984 Court opinion — the Justices said that the judiciary should no longer have to defer to federal agency interpretations of laws. Existing federal law “requires courts to exercise their independent judgment in deciding whether an agency has acted within its statutory authority,” said the Court, in stating why Chevron should be overruled.
Writing for the majority in the combined cases — Relentless v. Department of Commerce and Loper Bright Enterprises v. Raimondo — Chief Justice John Roberts Jr. wrote that “agencies have no special competence in resolving statutory ambiguities. Courts do.”
In a dissenting opinion, Justice Elena Kagan said the decision was a judicial power grab and would result in a “jolt to the legal system.” She was joined by Justices Sonia Sotomayor and Ketanji Brown Jackson.
The opinion will have many repercussions, said lawyer and Supreme Court watcher Amy Howe. The Chevron ruling has been “one of the most important rulings on federal administrative law, cited by federal courts more than 18,000 times,” she wrote on her blog.
For example, without the long-standing deference to agencies under Chevron, healthcare providers may have more opportunities to challenge how federal officials set Medicare reimbursement for hospital procedures or prescription drugs, Baker Donelson healthcare attorneys McKenna Cloud and Thomas Barnard wrote in an analysis.
Seventeen health organizations issued a joint statement signaling their disappointment.
“We anticipate that today’s ruling will cause significant disruption to publicly funded health insurance programs, to the stability of this country’s healthcare and food and drug review systems, and to the health and well-being of the patients and consumers we serve,” wrote the organizations, which included American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, ALS Association, American Heart Association, American Lung Association, American Public Health Association, American Thoracic Society, Bazelon Center for Mental Health Law, Campaign for Tobacco-Free Kids, Child Neurology Foundation, Epilepsy Foundation, Muscular Dystrophy Association, National Health Law Program, Physicians for Social Responsibility, The Leukemia & Lymphoma Society, and Truth Initiative.
“It’s much harder for agencies to exercise power without some power to interpret statues. This is big,” wrote Berkeley Law Professor Orin Kerr on X.
A New, Uncertain Landscape for Healthcare
In the original Chevron case, the Court ruled that federal agencies had relevant expertise and should be given deference in resolving ambiguities that Congress had not spelled out in legislation.
In Relentless and Loper Bright, the plaintiffs argued that federal agencies overstepped their authority by issuing a rule that required commercial fishing vessels to pay for professional observers to monitor their catch.
In a statement after Friday’s ruling, the Relentless plaintiffs’ attorneys said that the decision “will recalibrate the balance of power between agencies and courts” and “make it harder for those agencies to adopt regulatory programs that exceed the authority conferred on them by Congress.”
Some predicted chaos in the wake of the ruling.
“Overturning Chevron could invite legal challenges to any and all agency determinations of ambiguous statutes by any stakeholder, leaving individual courts with the impractical task of determining the ‘correct’ meaning of statutes without the benefit of requisite expertise, practical experience, or public engagement,” wrote Sahil Agrawal, MD, PhD, Joseph S. Ross, MD, and Reshma Ramachandran, MD, in JAMA in an opinion piece in March that considered the ramifications of overturning Chevron.
“The spillover effects for medicine and public health, in turn, will be consequential,” they wrote.
In an analysis published in April, the Kaiser Family Foundation noted many potential ramifications on patient and consumer protections in the health insurance market. For instance, courts could vacate current rules governing protections under the Affordable Care Act, including that health plans offer a range of free preventive health services, such as breast, cervical, colon, and lung cancer screening.
Congressional, White House Reaction
Many legal observers said the ruling will have the effect of requiring Congress to write ever-more dense and exacting legislation to prevent agencies from interpreting any gaps.
Some members of Congress welcomed the decision.
Senate Minority Leader Mitch McConnell (R-Kentucky) said in a statement, “The Constitution vests Congress with the sole authority to make law,” adding, “the Supreme Court made it clear today that our system of government leaves no room for an unelected bureaucracy to co-opt this authority for itself.”
In a post on X, Senate Majority Leader Chuck Schumer (D-New York) accused the Court of siding with “special interests and giant corporations.” Added Mr. Schumer, “Their headlong rush to overturn 40 years of precedent and impose their own radical views is appalling.”
White House Press Secretary Karine Jean-Pierre said in a statement that “While this decision undermines the ability of federal agencies to use their expertise as Congress intended to make government work for the people, the Biden-Harris Administration will not relent in our efforts to protect and serve every American.”
A version of this article first appeared on Medscape.com.
Thanks, But No Thanks
She was young, neatly dressed, professional. I don’t remember her name, though she handed me a business card as soon as I stepped up to the front window.
I thought she was a new drug rep to my territory, and I usually try to say “hi” when they first come in. They’re just doing their job, and I don’t mind chatting for a few minutes.
But she, as it turned out, was here for a whole new thing. Taking out a glossy brochure, she dived into a spiel about my offering a medical credit card through my office. I would get paid quickly, I might even get some extra money from patient interest payments, it is convenient for patients, win-win situation all around, yadda yadda yadda.
I smiled, thanked her for coming in, but told her this wasn’t a good fit for my practice.
I’m well aware that keeping a small practice afloat ain’t easy. Medicine is one of the few fields (unless you’re strictly doing cash pay) where we can’t raise prices to keep up with inflation. Well, we can, but what we get paid won’t change. That’s the nature of dealing with Medicare and insurance. What you charge and what you’ll get (and have to accept) are generally not the same.
But even so, I try to stick with what I know — being a neurologist. I’m not here to offer a range of financial services. I have neither the time, nor interest, to run a patient’s copay while trying to sell them on a medical credit card.
For that matter I’m not going to set up shop selling vitamin supplements, hangover-curing infusions, endorsing products on X, or any of the other dubious things touted as “thinking outside the box” ways to increase revenue.
I suppose some will say I’m old-fashioned, or this is why my practice operates on a thin margin, or that I’m focusing more on patients than business. I don’t mind. Caring for patients is why I’m here.
I also hear the argument that if I don’t market a medical credit card (or whatever), someone else will. That’s fine. Let them. I wish them good luck. It’s just not for me.
Like I’ve said in the past, I’m an old dog, but a happy one. I’ll leave the new tricks to someone else.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
She was young, neatly dressed, professional. I don’t remember her name, though she handed me a business card as soon as I stepped up to the front window.
I thought she was a new drug rep to my territory, and I usually try to say “hi” when they first come in. They’re just doing their job, and I don’t mind chatting for a few minutes.
But she, as it turned out, was here for a whole new thing. Taking out a glossy brochure, she dived into a spiel about my offering a medical credit card through my office. I would get paid quickly, I might even get some extra money from patient interest payments, it is convenient for patients, win-win situation all around, yadda yadda yadda.
I smiled, thanked her for coming in, but told her this wasn’t a good fit for my practice.
I’m well aware that keeping a small practice afloat ain’t easy. Medicine is one of the few fields (unless you’re strictly doing cash pay) where we can’t raise prices to keep up with inflation. Well, we can, but what we get paid won’t change. That’s the nature of dealing with Medicare and insurance. What you charge and what you’ll get (and have to accept) are generally not the same.
But even so, I try to stick with what I know — being a neurologist. I’m not here to offer a range of financial services. I have neither the time, nor interest, to run a patient’s copay while trying to sell them on a medical credit card.
For that matter I’m not going to set up shop selling vitamin supplements, hangover-curing infusions, endorsing products on X, or any of the other dubious things touted as “thinking outside the box” ways to increase revenue.
I suppose some will say I’m old-fashioned, or this is why my practice operates on a thin margin, or that I’m focusing more on patients than business. I don’t mind. Caring for patients is why I’m here.
I also hear the argument that if I don’t market a medical credit card (or whatever), someone else will. That’s fine. Let them. I wish them good luck. It’s just not for me.
Like I’ve said in the past, I’m an old dog, but a happy one. I’ll leave the new tricks to someone else.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
She was young, neatly dressed, professional. I don’t remember her name, though she handed me a business card as soon as I stepped up to the front window.
I thought she was a new drug rep to my territory, and I usually try to say “hi” when they first come in. They’re just doing their job, and I don’t mind chatting for a few minutes.
But she, as it turned out, was here for a whole new thing. Taking out a glossy brochure, she dived into a spiel about my offering a medical credit card through my office. I would get paid quickly, I might even get some extra money from patient interest payments, it is convenient for patients, win-win situation all around, yadda yadda yadda.
I smiled, thanked her for coming in, but told her this wasn’t a good fit for my practice.
I’m well aware that keeping a small practice afloat ain’t easy. Medicine is one of the few fields (unless you’re strictly doing cash pay) where we can’t raise prices to keep up with inflation. Well, we can, but what we get paid won’t change. That’s the nature of dealing with Medicare and insurance. What you charge and what you’ll get (and have to accept) are generally not the same.
But even so, I try to stick with what I know — being a neurologist. I’m not here to offer a range of financial services. I have neither the time, nor interest, to run a patient’s copay while trying to sell them on a medical credit card.
For that matter I’m not going to set up shop selling vitamin supplements, hangover-curing infusions, endorsing products on X, or any of the other dubious things touted as “thinking outside the box” ways to increase revenue.
I suppose some will say I’m old-fashioned, or this is why my practice operates on a thin margin, or that I’m focusing more on patients than business. I don’t mind. Caring for patients is why I’m here.
I also hear the argument that if I don’t market a medical credit card (or whatever), someone else will. That’s fine. Let them. I wish them good luck. It’s just not for me.
Like I’ve said in the past, I’m an old dog, but a happy one. I’ll leave the new tricks to someone else.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
FDA Proposes that Interchangeability Status for Biosimilars Doesn’t Need Switching Studies
The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.
“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”
An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.
While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”
However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.
“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.
“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.
The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.
“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”
An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.
While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”
However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.
“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.
“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.
The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.
“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”
An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.
While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”
However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.
“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.
“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.
The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.
A version of this article first appeared on Medscape.com.
Scope of Practice Concerns Lead to Hospital’s Temp Ban on CRNAs
Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.
In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.
The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.
Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.
“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.
In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”
The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.
Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
CRNA Claims to Be in Charge
Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.
According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.
The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”
Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”
In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.
CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.
CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.
Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.
The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
Scope of Practice Confusion?
But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.
Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.
“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.
It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.
Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.
The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.
Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
Filling a Gap
Nurse anesthetists see things differently.
CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.
She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”
Most nurse anesthetists see themselves as independent practitioners.
Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.
Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.
The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.
Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.
“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”
There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.
Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.
“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”
A version of this article first appeared on Medscape.com.
Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.
In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.
The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.
Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.
“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.
In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”
The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.
Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
CRNA Claims to Be in Charge
Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.
According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.
The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”
Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”
In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.
CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.
CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.
Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.
The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
Scope of Practice Confusion?
But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.
Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.
“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.
It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.
Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.
The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.
Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
Filling a Gap
Nurse anesthetists see things differently.
CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.
She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”
Most nurse anesthetists see themselves as independent practitioners.
Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.
Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.
The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.
Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.
“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”
There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.
Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.
“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”
A version of this article first appeared on Medscape.com.
Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.
In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.
The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.
Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.
“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.
In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”
The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.
Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
CRNA Claims to Be in Charge
Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.
According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.
The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”
Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”
In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.
CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.
CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.
Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.
The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
Scope of Practice Confusion?
But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.
Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.
“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.
It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.
Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.
The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.
Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
Filling a Gap
Nurse anesthetists see things differently.
CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.
She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”
Most nurse anesthetists see themselves as independent practitioners.
Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.
Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.
The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.
Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.
“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”
There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.
Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.
“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”
A version of this article first appeared on Medscape.com.
How to Make Life Decisions
Halifax, Nova Scotia; American Samoa; Queens, New York; Lansing, Michigan; Gurugram, India. I often ask patients where they’re from. Practicing in San Diego, the answers are a geography lesson. People from around the world come here. I sometimes add the more interesting question: How’d you end up here? Many took the three highways to San Diego: the Navy, the defense industry (like General Dynamics), or followed a partner. My Queens patient had a better answer: Super Bowl XXII. On Sunday, Jan. 31st, 1988, the Redskins played the Broncos in San Diego. John Elway and the Broncos lost, but it didn’t matter. “I was scrapin’ the ice off my windshield that Monday morning when I thought, that’s it. I’m done! I drove to the garage where I worked and quit on the spot. Then I drove home and packed my bags.”
In a paper on how to make life decisions, this guy would be Exhibit A: “Don’t overthink it.” That approach might not be suitable for everyone, or for every decision. It might actually be an example of how not to make life decisions (more on that later). But,
The first treatise on this subject was a paper by one Franklin, Ben in 1772. Providing advice to a friend on how to make a career decision, Franklin argued: “My way is to divide half a sheet of paper by a line into two columns; writing over the one Pro and over the other Con.” This “moral algebra” as he called it was a framework to put rigor to a messy, organic problem.
The flaw in this method is that in the end you have two lists. Then what? Do the length of the lists decide? What if some factors are more important? Well, let’s add tools to help. You could use a spreadsheet and assign weights to each variable. Then sum the values and choose based on that. So if “not scraping ice off your windshield” is twice as important as “doubling your rent,” then you’ve got your answer. But what if you aren’t good at estimating how important things are? Actually, most of us are pretty awful at assigning weights to life variables – having bags of money is the consummate example. Seems important, but because of habituation, it turns out to not be sustainable. Note Exhibit B, our wealthy neighbor who owns a Lambo and G-Wagen (AMG squared, of course), who just parked a Cybertruck in his driveway. Realizing the risk of depending on peoples’ flawed judgment, companies instead use statistical modeling called bootstrap aggregating to “vote” on the weights for variables in a prediction. If you aren’t sure how important a new Rivian or walking to the beach would be, a model can answer that for you! It’s a bit disconcerting, I know. I mean, how can a model know what we’d like? Wait, isn’t that how Netflix picks stuff for you? Exactly.
Ok, so why don’t we just ask our friendly personal AI? “OK, ChatGPT, given what you know about me, where can I have it all?” Alas, here we slam into a glass wall. It seems the answer is out there but even our life-changing magical AI tools fail us. Mathematically, it is impossible to have it all. An illustrative example of this is called the economic “impossible trinity problem.” Even the most sophisticated algorithm cannot find an optional solution to some trinities such as fixed foreign exchange rate, free capital movement, and an independent monetary policy. Economists have concluded you must trade off one to have the other two. Impossible trinities are common in economics and in life. Armistead Maupin in his “Tales of the City” codifies it as Mona’s Law, the essence of which is: You cannot have the perfect job, the perfect partner, and the perfect house at the same time. (See Exhibit C, one Tom Brady).
This brings me to my final point, hard decisions are matters of the heart and experiencing life is the best way to understand its beautiful chaos. If making rash judgments is ill-advised and using technology cannot solve all problems (try asking your AI buddy for the square root of 2 as a fraction) what tools can we use? Maybe try reading more novels. They allow us to experience multiple lifetimes in a short time, which is what we need to learn what matters. Reading Dorothea’s choice at the end of “Middlemarch” is a nice example. Should she give up Lowick Manor and marry the penniless Ladislaw or keep it and use her wealth to help others? Seeing her struggle helps us understand how to answer questions like: Should I give up my academic practice or marry that guy or move to Texas? These cannot be reduced to arithmetic. The only way to know is to know as much of life as possible.
My last visit with my Queens patient was our last together. He’s divorced and moving from San Diego to Gallatin, Tennessee. “I’ve paid my last taxes to California, Doc. I decided that’s it, I’m done!” Perhaps he should have read “The Grapes of Wrath” before he set out for California in the first place.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Halifax, Nova Scotia; American Samoa; Queens, New York; Lansing, Michigan; Gurugram, India. I often ask patients where they’re from. Practicing in San Diego, the answers are a geography lesson. People from around the world come here. I sometimes add the more interesting question: How’d you end up here? Many took the three highways to San Diego: the Navy, the defense industry (like General Dynamics), or followed a partner. My Queens patient had a better answer: Super Bowl XXII. On Sunday, Jan. 31st, 1988, the Redskins played the Broncos in San Diego. John Elway and the Broncos lost, but it didn’t matter. “I was scrapin’ the ice off my windshield that Monday morning when I thought, that’s it. I’m done! I drove to the garage where I worked and quit on the spot. Then I drove home and packed my bags.”
In a paper on how to make life decisions, this guy would be Exhibit A: “Don’t overthink it.” That approach might not be suitable for everyone, or for every decision. It might actually be an example of how not to make life decisions (more on that later). But,
The first treatise on this subject was a paper by one Franklin, Ben in 1772. Providing advice to a friend on how to make a career decision, Franklin argued: “My way is to divide half a sheet of paper by a line into two columns; writing over the one Pro and over the other Con.” This “moral algebra” as he called it was a framework to put rigor to a messy, organic problem.
The flaw in this method is that in the end you have two lists. Then what? Do the length of the lists decide? What if some factors are more important? Well, let’s add tools to help. You could use a spreadsheet and assign weights to each variable. Then sum the values and choose based on that. So if “not scraping ice off your windshield” is twice as important as “doubling your rent,” then you’ve got your answer. But what if you aren’t good at estimating how important things are? Actually, most of us are pretty awful at assigning weights to life variables – having bags of money is the consummate example. Seems important, but because of habituation, it turns out to not be sustainable. Note Exhibit B, our wealthy neighbor who owns a Lambo and G-Wagen (AMG squared, of course), who just parked a Cybertruck in his driveway. Realizing the risk of depending on peoples’ flawed judgment, companies instead use statistical modeling called bootstrap aggregating to “vote” on the weights for variables in a prediction. If you aren’t sure how important a new Rivian or walking to the beach would be, a model can answer that for you! It’s a bit disconcerting, I know. I mean, how can a model know what we’d like? Wait, isn’t that how Netflix picks stuff for you? Exactly.
Ok, so why don’t we just ask our friendly personal AI? “OK, ChatGPT, given what you know about me, where can I have it all?” Alas, here we slam into a glass wall. It seems the answer is out there but even our life-changing magical AI tools fail us. Mathematically, it is impossible to have it all. An illustrative example of this is called the economic “impossible trinity problem.” Even the most sophisticated algorithm cannot find an optional solution to some trinities such as fixed foreign exchange rate, free capital movement, and an independent monetary policy. Economists have concluded you must trade off one to have the other two. Impossible trinities are common in economics and in life. Armistead Maupin in his “Tales of the City” codifies it as Mona’s Law, the essence of which is: You cannot have the perfect job, the perfect partner, and the perfect house at the same time. (See Exhibit C, one Tom Brady).
This brings me to my final point, hard decisions are matters of the heart and experiencing life is the best way to understand its beautiful chaos. If making rash judgments is ill-advised and using technology cannot solve all problems (try asking your AI buddy for the square root of 2 as a fraction) what tools can we use? Maybe try reading more novels. They allow us to experience multiple lifetimes in a short time, which is what we need to learn what matters. Reading Dorothea’s choice at the end of “Middlemarch” is a nice example. Should she give up Lowick Manor and marry the penniless Ladislaw or keep it and use her wealth to help others? Seeing her struggle helps us understand how to answer questions like: Should I give up my academic practice or marry that guy or move to Texas? These cannot be reduced to arithmetic. The only way to know is to know as much of life as possible.
My last visit with my Queens patient was our last together. He’s divorced and moving from San Diego to Gallatin, Tennessee. “I’ve paid my last taxes to California, Doc. I decided that’s it, I’m done!” Perhaps he should have read “The Grapes of Wrath” before he set out for California in the first place.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Halifax, Nova Scotia; American Samoa; Queens, New York; Lansing, Michigan; Gurugram, India. I often ask patients where they’re from. Practicing in San Diego, the answers are a geography lesson. People from around the world come here. I sometimes add the more interesting question: How’d you end up here? Many took the three highways to San Diego: the Navy, the defense industry (like General Dynamics), or followed a partner. My Queens patient had a better answer: Super Bowl XXII. On Sunday, Jan. 31st, 1988, the Redskins played the Broncos in San Diego. John Elway and the Broncos lost, but it didn’t matter. “I was scrapin’ the ice off my windshield that Monday morning when I thought, that’s it. I’m done! I drove to the garage where I worked and quit on the spot. Then I drove home and packed my bags.”
In a paper on how to make life decisions, this guy would be Exhibit A: “Don’t overthink it.” That approach might not be suitable for everyone, or for every decision. It might actually be an example of how not to make life decisions (more on that later). But,
The first treatise on this subject was a paper by one Franklin, Ben in 1772. Providing advice to a friend on how to make a career decision, Franklin argued: “My way is to divide half a sheet of paper by a line into two columns; writing over the one Pro and over the other Con.” This “moral algebra” as he called it was a framework to put rigor to a messy, organic problem.
The flaw in this method is that in the end you have two lists. Then what? Do the length of the lists decide? What if some factors are more important? Well, let’s add tools to help. You could use a spreadsheet and assign weights to each variable. Then sum the values and choose based on that. So if “not scraping ice off your windshield” is twice as important as “doubling your rent,” then you’ve got your answer. But what if you aren’t good at estimating how important things are? Actually, most of us are pretty awful at assigning weights to life variables – having bags of money is the consummate example. Seems important, but because of habituation, it turns out to not be sustainable. Note Exhibit B, our wealthy neighbor who owns a Lambo and G-Wagen (AMG squared, of course), who just parked a Cybertruck in his driveway. Realizing the risk of depending on peoples’ flawed judgment, companies instead use statistical modeling called bootstrap aggregating to “vote” on the weights for variables in a prediction. If you aren’t sure how important a new Rivian or walking to the beach would be, a model can answer that for you! It’s a bit disconcerting, I know. I mean, how can a model know what we’d like? Wait, isn’t that how Netflix picks stuff for you? Exactly.
Ok, so why don’t we just ask our friendly personal AI? “OK, ChatGPT, given what you know about me, where can I have it all?” Alas, here we slam into a glass wall. It seems the answer is out there but even our life-changing magical AI tools fail us. Mathematically, it is impossible to have it all. An illustrative example of this is called the economic “impossible trinity problem.” Even the most sophisticated algorithm cannot find an optional solution to some trinities such as fixed foreign exchange rate, free capital movement, and an independent monetary policy. Economists have concluded you must trade off one to have the other two. Impossible trinities are common in economics and in life. Armistead Maupin in his “Tales of the City” codifies it as Mona’s Law, the essence of which is: You cannot have the perfect job, the perfect partner, and the perfect house at the same time. (See Exhibit C, one Tom Brady).
This brings me to my final point, hard decisions are matters of the heart and experiencing life is the best way to understand its beautiful chaos. If making rash judgments is ill-advised and using technology cannot solve all problems (try asking your AI buddy for the square root of 2 as a fraction) what tools can we use? Maybe try reading more novels. They allow us to experience multiple lifetimes in a short time, which is what we need to learn what matters. Reading Dorothea’s choice at the end of “Middlemarch” is a nice example. Should she give up Lowick Manor and marry the penniless Ladislaw or keep it and use her wealth to help others? Seeing her struggle helps us understand how to answer questions like: Should I give up my academic practice or marry that guy or move to Texas? These cannot be reduced to arithmetic. The only way to know is to know as much of life as possible.
My last visit with my Queens patient was our last together. He’s divorced and moving from San Diego to Gallatin, Tennessee. “I’ve paid my last taxes to California, Doc. I decided that’s it, I’m done!” Perhaps he should have read “The Grapes of Wrath” before he set out for California in the first place.
Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].
Study Addresses Litigation Related to Cutaneous Energy-based Based Device Treatments
“The utilization of laser and energy-based devices (LEBD) has grown substantially,” corresponding author Scott Stratman, MD, MPH, and coauthors wrote in their study, which was published online in the Journal of the American Academy of Dermatology. “This has led to a rise in practitioners, both physicians and nonphysicians, who may lack the requisite training in LEBD procedures. Subsequently, procedures performed by these untrained practitioners have resulted in more lawsuits related to patient complications. As the demand for LEBD procedures and the number of practitioners performing these procedures increase, it remains paramount to characterize the trends of malpractice cases involving these procedures.”
Dr. Stratman, a dermatology resident at the Icahn School of Medicine at Mount Sinai, New York City, and colleagues queried the LexisNexis database from 1985 to Sept. 30, 2023, for all state, federal, and appellate cases that included the terms “negligence” or “malpractice” and “skin” and “laser.” After they removed duplicate cases and excluded cases that did not report dermatologic complications or cutaneous energy-based procedures, the final analysis included 75 cases.
Most of the appellants/plaintiffs (66; 88%) were women, a greater number of cases were in the Northeast (26; 34.7%) and the South (23; 30.7%), and the fewest cases were in the Midwest (12 [16%]). The most common anatomical sites were the face, head, and/or neck, and 43 of the cases (57.3%) were decided in favor of the appellee/defendant or the party defending against the appeal, while 29 (38.7%) were in favor of the appellant/plaintiff or the party appealing, and three cases (4%) did not report a verdict.
In other findings, plastic surgeons were the most litigated healthcare professionals (18; 24%), while 39 of the overall cases (52%) involved nonphysician operators (NPOs), 32 (42.7%) involved a physician operator, and 4 cases (5.3%) did not name a device operator. The most common procedure performed in the included cases was laser hair removal (33; 44%). Complications from energy-based devices included burns, scarring, and pigmentation changes. Statistically significant associations were neither found between verdict outcome and appellee/defendant type nor found between energy-device operator or anatomical site.
The authors acknowledged certain limitations of the study, including the fact that the LexisNexis database does not contain cases handled in out-of-court settlements and cases that underwent third-party arbitration.
“Physicians must recognize their responsibility when delegating procedures to NPOs and their role in supervision of these procedures,” they concluded. “Comprehensive training for physicians and their agents is necessary to diminish adverse outcomes and legal risks. Moreover, all practitioners should be held to the same standard of care. Familiarity with malpractice trends not only strengthens the patient-provider relationship but also equips providers with effective strategies to minimize the risk of legal repercussions.”
Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, who was asked to comment on the study, said that it “reaffirms previous studies which show that laser hair removal continues to be the most litigated procedure in laser surgery, and that nonphysician operators are most commonly litigated against. It further reiterates the importance of close supervision and expert training of procedures delegated by physicians.”
Neither the authors nor Dr. Avram reported having relevant financial disclosures.
A version of this article first appeared on Medscape.com.
“The utilization of laser and energy-based devices (LEBD) has grown substantially,” corresponding author Scott Stratman, MD, MPH, and coauthors wrote in their study, which was published online in the Journal of the American Academy of Dermatology. “This has led to a rise in practitioners, both physicians and nonphysicians, who may lack the requisite training in LEBD procedures. Subsequently, procedures performed by these untrained practitioners have resulted in more lawsuits related to patient complications. As the demand for LEBD procedures and the number of practitioners performing these procedures increase, it remains paramount to characterize the trends of malpractice cases involving these procedures.”
Dr. Stratman, a dermatology resident at the Icahn School of Medicine at Mount Sinai, New York City, and colleagues queried the LexisNexis database from 1985 to Sept. 30, 2023, for all state, federal, and appellate cases that included the terms “negligence” or “malpractice” and “skin” and “laser.” After they removed duplicate cases and excluded cases that did not report dermatologic complications or cutaneous energy-based procedures, the final analysis included 75 cases.
Most of the appellants/plaintiffs (66; 88%) were women, a greater number of cases were in the Northeast (26; 34.7%) and the South (23; 30.7%), and the fewest cases were in the Midwest (12 [16%]). The most common anatomical sites were the face, head, and/or neck, and 43 of the cases (57.3%) were decided in favor of the appellee/defendant or the party defending against the appeal, while 29 (38.7%) were in favor of the appellant/plaintiff or the party appealing, and three cases (4%) did not report a verdict.
In other findings, plastic surgeons were the most litigated healthcare professionals (18; 24%), while 39 of the overall cases (52%) involved nonphysician operators (NPOs), 32 (42.7%) involved a physician operator, and 4 cases (5.3%) did not name a device operator. The most common procedure performed in the included cases was laser hair removal (33; 44%). Complications from energy-based devices included burns, scarring, and pigmentation changes. Statistically significant associations were neither found between verdict outcome and appellee/defendant type nor found between energy-device operator or anatomical site.
The authors acknowledged certain limitations of the study, including the fact that the LexisNexis database does not contain cases handled in out-of-court settlements and cases that underwent third-party arbitration.
“Physicians must recognize their responsibility when delegating procedures to NPOs and their role in supervision of these procedures,” they concluded. “Comprehensive training for physicians and their agents is necessary to diminish adverse outcomes and legal risks. Moreover, all practitioners should be held to the same standard of care. Familiarity with malpractice trends not only strengthens the patient-provider relationship but also equips providers with effective strategies to minimize the risk of legal repercussions.”
Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, who was asked to comment on the study, said that it “reaffirms previous studies which show that laser hair removal continues to be the most litigated procedure in laser surgery, and that nonphysician operators are most commonly litigated against. It further reiterates the importance of close supervision and expert training of procedures delegated by physicians.”
Neither the authors nor Dr. Avram reported having relevant financial disclosures.
A version of this article first appeared on Medscape.com.
“The utilization of laser and energy-based devices (LEBD) has grown substantially,” corresponding author Scott Stratman, MD, MPH, and coauthors wrote in their study, which was published online in the Journal of the American Academy of Dermatology. “This has led to a rise in practitioners, both physicians and nonphysicians, who may lack the requisite training in LEBD procedures. Subsequently, procedures performed by these untrained practitioners have resulted in more lawsuits related to patient complications. As the demand for LEBD procedures and the number of practitioners performing these procedures increase, it remains paramount to characterize the trends of malpractice cases involving these procedures.”
Dr. Stratman, a dermatology resident at the Icahn School of Medicine at Mount Sinai, New York City, and colleagues queried the LexisNexis database from 1985 to Sept. 30, 2023, for all state, federal, and appellate cases that included the terms “negligence” or “malpractice” and “skin” and “laser.” After they removed duplicate cases and excluded cases that did not report dermatologic complications or cutaneous energy-based procedures, the final analysis included 75 cases.
Most of the appellants/plaintiffs (66; 88%) were women, a greater number of cases were in the Northeast (26; 34.7%) and the South (23; 30.7%), and the fewest cases were in the Midwest (12 [16%]). The most common anatomical sites were the face, head, and/or neck, and 43 of the cases (57.3%) were decided in favor of the appellee/defendant or the party defending against the appeal, while 29 (38.7%) were in favor of the appellant/plaintiff or the party appealing, and three cases (4%) did not report a verdict.
In other findings, plastic surgeons were the most litigated healthcare professionals (18; 24%), while 39 of the overall cases (52%) involved nonphysician operators (NPOs), 32 (42.7%) involved a physician operator, and 4 cases (5.3%) did not name a device operator. The most common procedure performed in the included cases was laser hair removal (33; 44%). Complications from energy-based devices included burns, scarring, and pigmentation changes. Statistically significant associations were neither found between verdict outcome and appellee/defendant type nor found between energy-device operator or anatomical site.
The authors acknowledged certain limitations of the study, including the fact that the LexisNexis database does not contain cases handled in out-of-court settlements and cases that underwent third-party arbitration.
“Physicians must recognize their responsibility when delegating procedures to NPOs and their role in supervision of these procedures,” they concluded. “Comprehensive training for physicians and their agents is necessary to diminish adverse outcomes and legal risks. Moreover, all practitioners should be held to the same standard of care. Familiarity with malpractice trends not only strengthens the patient-provider relationship but also equips providers with effective strategies to minimize the risk of legal repercussions.”
Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, who was asked to comment on the study, said that it “reaffirms previous studies which show that laser hair removal continues to be the most litigated procedure in laser surgery, and that nonphysician operators are most commonly litigated against. It further reiterates the importance of close supervision and expert training of procedures delegated by physicians.”
Neither the authors nor Dr. Avram reported having relevant financial disclosures.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
CMS Announces End to Cyberattack Relief Program
The Centers for Medicare & Medicaid Services (CMS) has announced the conclusion of a program that provided billions in early Medicare payments to those affected by the Change Healthcare/UnitedHealth Group cyberattack last winter.
CMS reported that the program advanced more than $2.55 billion in Medicare payments to > 4200 Part A providers, including hospitals, and more than $717.18 million in payments to Part B suppliers such as physicians, nonphysician practitioners, and durable medical equipment suppliers.
According to CMS, the Medicare billing system is now functioning properly, and 96% of the early payments have been recovered. The advances were to represent ≤ 30 days of typical claims payments in a 3-month period of 2023, with full repayment expected within 90 days through “automatic recoupment from Medicare claims” — no extensions allowed.
The agency took a victory lap regarding its response. “In the face of one of the most widespread cyberattacks on the US health care industry, CMS promptly took action to get providers and suppliers access to the funds they needed to continue providing patients with vital care,” CMS Administrator Chiquita Brooks-LaSure said in a statement. “Our efforts helped minimize the disruptive fallout from this incident, and we will remain vigilant to be ready to address future events.”
Ongoing Concerns from Health Care Organizations
Ben Teicher, an American Hospital Association spokesman, said that the organization hopes that CMS will be responsive if there’s more need for action after the advance payment program expires. The organization represents about 5000 hospitals, health care systems, and other providers.
“Our members report that the aftereffects of this event will likely be felt throughout the remainder of the year,” he said. According to Teicher, hospitals remain concerned about their ability to process claims and appeal denials, the safety of reconnecting to cyber services, and access to information needed to bill patients and reconcile payments.
In addition, hospitals are concerned about “financial support to mitigate the considerable costs incurred as a result of the cyberattack,” he said.
Charlene MacDonald, executive vice-president of public affairs at the Federation of American Hospitals, which represents more than 1000 for-profit hospitals, sent a statement to this news organization that said some providers “are still feeling the effects of care denials and delays caused by insurer inaction.
“We appreciate that the Administration acted within its authority to support providers during this unprecedented crisis and blunt these devastating impacts, especially because a vast majority of managed care companies failed to step up to the plate,” she said. “It is now time to shift our focus to holding plans accountable for using tactics to delay and deny needed patient care.”
Cyberattack Impact and Response
The ransom-based cyberattack against Change Healthcare/UnitedHealth Group targeted an electronic data interchange clearing house processing payer reimbursement systems, disrupting cash flows at hospitals and medical practices, and affecting patient access to prescriptions and life-saving therapy.
Change Healthcare — part of the UnitedHealth Group subsidiary Optum — processes half of all medical claims, according to a Department of Justice lawsuit. The American Hospital Association described the cyberattack as “the most significant and consequential incident of its kind” in US history.
By late March, UnitedHealth Group said nearly all medical and pharmacy claims were processing properly, while a deputy secretary of the US Department of Health & Human Services told clinicians that officials were focusing on the last group of clinicians who were facing cash-flow problems.
Still, a senior advisor with CMS told providers at that time that “we have heard from so many providers over the last several weeks who are really struggling to make ends meet right now or who are worried that they will not be able to make payroll in the weeks to come.”
Randy Dotinga is a freelance health/medical reporter and board member of the Association of Health Care Journalists.
A version of this article appeared on Medscape.com.
The Centers for Medicare & Medicaid Services (CMS) has announced the conclusion of a program that provided billions in early Medicare payments to those affected by the Change Healthcare/UnitedHealth Group cyberattack last winter.
CMS reported that the program advanced more than $2.55 billion in Medicare payments to > 4200 Part A providers, including hospitals, and more than $717.18 million in payments to Part B suppliers such as physicians, nonphysician practitioners, and durable medical equipment suppliers.
According to CMS, the Medicare billing system is now functioning properly, and 96% of the early payments have been recovered. The advances were to represent ≤ 30 days of typical claims payments in a 3-month period of 2023, with full repayment expected within 90 days through “automatic recoupment from Medicare claims” — no extensions allowed.
The agency took a victory lap regarding its response. “In the face of one of the most widespread cyberattacks on the US health care industry, CMS promptly took action to get providers and suppliers access to the funds they needed to continue providing patients with vital care,” CMS Administrator Chiquita Brooks-LaSure said in a statement. “Our efforts helped minimize the disruptive fallout from this incident, and we will remain vigilant to be ready to address future events.”
Ongoing Concerns from Health Care Organizations
Ben Teicher, an American Hospital Association spokesman, said that the organization hopes that CMS will be responsive if there’s more need for action after the advance payment program expires. The organization represents about 5000 hospitals, health care systems, and other providers.
“Our members report that the aftereffects of this event will likely be felt throughout the remainder of the year,” he said. According to Teicher, hospitals remain concerned about their ability to process claims and appeal denials, the safety of reconnecting to cyber services, and access to information needed to bill patients and reconcile payments.
In addition, hospitals are concerned about “financial support to mitigate the considerable costs incurred as a result of the cyberattack,” he said.
Charlene MacDonald, executive vice-president of public affairs at the Federation of American Hospitals, which represents more than 1000 for-profit hospitals, sent a statement to this news organization that said some providers “are still feeling the effects of care denials and delays caused by insurer inaction.
“We appreciate that the Administration acted within its authority to support providers during this unprecedented crisis and blunt these devastating impacts, especially because a vast majority of managed care companies failed to step up to the plate,” she said. “It is now time to shift our focus to holding plans accountable for using tactics to delay and deny needed patient care.”
Cyberattack Impact and Response
The ransom-based cyberattack against Change Healthcare/UnitedHealth Group targeted an electronic data interchange clearing house processing payer reimbursement systems, disrupting cash flows at hospitals and medical practices, and affecting patient access to prescriptions and life-saving therapy.
Change Healthcare — part of the UnitedHealth Group subsidiary Optum — processes half of all medical claims, according to a Department of Justice lawsuit. The American Hospital Association described the cyberattack as “the most significant and consequential incident of its kind” in US history.
By late March, UnitedHealth Group said nearly all medical and pharmacy claims were processing properly, while a deputy secretary of the US Department of Health & Human Services told clinicians that officials were focusing on the last group of clinicians who were facing cash-flow problems.
Still, a senior advisor with CMS told providers at that time that “we have heard from so many providers over the last several weeks who are really struggling to make ends meet right now or who are worried that they will not be able to make payroll in the weeks to come.”
Randy Dotinga is a freelance health/medical reporter and board member of the Association of Health Care Journalists.
A version of this article appeared on Medscape.com.
The Centers for Medicare & Medicaid Services (CMS) has announced the conclusion of a program that provided billions in early Medicare payments to those affected by the Change Healthcare/UnitedHealth Group cyberattack last winter.
CMS reported that the program advanced more than $2.55 billion in Medicare payments to > 4200 Part A providers, including hospitals, and more than $717.18 million in payments to Part B suppliers such as physicians, nonphysician practitioners, and durable medical equipment suppliers.
According to CMS, the Medicare billing system is now functioning properly, and 96% of the early payments have been recovered. The advances were to represent ≤ 30 days of typical claims payments in a 3-month period of 2023, with full repayment expected within 90 days through “automatic recoupment from Medicare claims” — no extensions allowed.
The agency took a victory lap regarding its response. “In the face of one of the most widespread cyberattacks on the US health care industry, CMS promptly took action to get providers and suppliers access to the funds they needed to continue providing patients with vital care,” CMS Administrator Chiquita Brooks-LaSure said in a statement. “Our efforts helped minimize the disruptive fallout from this incident, and we will remain vigilant to be ready to address future events.”
Ongoing Concerns from Health Care Organizations
Ben Teicher, an American Hospital Association spokesman, said that the organization hopes that CMS will be responsive if there’s more need for action after the advance payment program expires. The organization represents about 5000 hospitals, health care systems, and other providers.
“Our members report that the aftereffects of this event will likely be felt throughout the remainder of the year,” he said. According to Teicher, hospitals remain concerned about their ability to process claims and appeal denials, the safety of reconnecting to cyber services, and access to information needed to bill patients and reconcile payments.
In addition, hospitals are concerned about “financial support to mitigate the considerable costs incurred as a result of the cyberattack,” he said.
Charlene MacDonald, executive vice-president of public affairs at the Federation of American Hospitals, which represents more than 1000 for-profit hospitals, sent a statement to this news organization that said some providers “are still feeling the effects of care denials and delays caused by insurer inaction.
“We appreciate that the Administration acted within its authority to support providers during this unprecedented crisis and blunt these devastating impacts, especially because a vast majority of managed care companies failed to step up to the plate,” she said. “It is now time to shift our focus to holding plans accountable for using tactics to delay and deny needed patient care.”
Cyberattack Impact and Response
The ransom-based cyberattack against Change Healthcare/UnitedHealth Group targeted an electronic data interchange clearing house processing payer reimbursement systems, disrupting cash flows at hospitals and medical practices, and affecting patient access to prescriptions and life-saving therapy.
Change Healthcare — part of the UnitedHealth Group subsidiary Optum — processes half of all medical claims, according to a Department of Justice lawsuit. The American Hospital Association described the cyberattack as “the most significant and consequential incident of its kind” in US history.
By late March, UnitedHealth Group said nearly all medical and pharmacy claims were processing properly, while a deputy secretary of the US Department of Health & Human Services told clinicians that officials were focusing on the last group of clinicians who were facing cash-flow problems.
Still, a senior advisor with CMS told providers at that time that “we have heard from so many providers over the last several weeks who are really struggling to make ends meet right now or who are worried that they will not be able to make payroll in the weeks to come.”
Randy Dotinga is a freelance health/medical reporter and board member of the Association of Health Care Journalists.
A version of this article appeared on Medscape.com.
Is This Journal Legit? Predatory Publishers
This transcript has been edited for clarity.
Andrew N. Wilner, MD: My guest today is Dr. Jose Merino, editor in chief of the Neurology family of journals and professor of neurology and co-vice chair of education at Georgetown University in Washington, DC.
Our program today is a follow-up of Dr. Merino’s presentation at the recent American Academy of Neurology meeting in Denver, Colorado. Along with two other panelists, Dr. Merino discussed the role of open-access publication and the dangers of predatory journals.
Jose G. Merino, MD, MPhil: Thank you for having me here. It’s a pleasure.
Open Access Defined
Dr. Wilner: I remember when publication in neurology was pretty straightforward. It was either the green journal or the blue journal, but things have certainly changed. I think one topic that is not clear to everyone is this concept of open access. Could you define that for us?
Dr. Merino: Sure. Open access is a mode of publication that fosters more open or accessible science. The idea of open access is that it combines two main elements. One is that the papers that are published become immediately available to anybody with an internet connection anywhere in the world without any restrictions.
The second important element from open access, which makes it different from other models we can talk about, is the fact that the authors retain the copyright of their work, but they give the journal and readers a license to use, reproduce, and modify the content.
This is different, for example, from instances where we have funder mandates. For example, NIH papers have to become available 6 months after publication, so they’re available to everybody but not immediately.
Dr. Wilner: I remember that when a journal article was published, say, in Neurology, if you didn’t have a subscription to Neurology, you went to the library that hopefully had a subscription.
If they didn’t have it, you would write to the author and say, “Hey, I heard you have this great paper because the abstract was out there. Could you send me a reprint?” Has that whole universe evaporated?
Dr. Merino: It depends on how the paper is published. For example, in Neurology, some of the research we publish is open access. Basically, if you have an internet connection, you can access the paper.
That’s the case for papers published in our wholly open-access journals in the Neurology family like Neurology Neuroimmunology & Neuroinflammation, Neurology Genetics, or Neurology Education.
For other papers that are published in Neurology, not under open access, there is a paywall. For some of them, the paywall comes down after a few months based on funder mandates and so on. As I was mentioning, the NIH-funded papers are available 6 months later.
In the first 6 months, you may have to go to your library, and if your library has a subscription, you can download it directly. [This is also true for] those that always stay behind the paywall, where you have to have a subscription or your library has to have a subscription.
Is Pay to Publish a Red Flag?
Dr. Wilner: I’m a professional writer. With any luck, when I write something, I get paid to write it. There’s been a long tradition in academic medicine that when you submit an article to, say, Neurology, you don’t get paid as an author for the publication. Your reward is the honor of it being published.
Neurology supports itself in various ways, including advertising and so on. That’s been the contract: free publication for work that merits it, and the journal survives on its own.
With open access, one of the things that’s happened is that — and I’ve published open access myself — is that I get a notification that I need to pay to have my article that I’ve slaved over published. Explain that, please.
Dr. Merino: This is the issue with open access. As I mentioned, the paper gets published. You’re giving the journal a license to publish it. You’re retaining the copyright of your work. That means that the journal cannot make money or support itself by just publishing open access because they belong to you.
Typically, open-access journals are not in print and don’t have much in terms of advertising. The contract is you’re giving me a license to publish it, but it’s your journal, so you’re paying a fee for the journal expenses to basically produce your paper. That’s what’s happening with open access.
That’s been recognized with many funders, for example, with NIH funding or many of the European funders, they’re including open-access fees as part of their funding for research. Now, of course, this doesn’t help if you’re not a funded researcher or if you’re a fellow who’s doing work and so on.
Typically, most journals will have waived fees or lower fees for these situations. The reason for the open-access fee is the fact that you’re retaining the copyright. You’re not giving it to the journal who can then use it to generate its revenue for supporting itself, the editorial staff, and so on.
Dr. Wilner: This idea of charging for publication has created a satellite business of what are called predatory journals. How does one know if the open-access journal that I’m submitting to is really just in the business of wanting my $300 or my $900 to get published? How do I know if that’s a reasonable place to publish?
Predatory Journals
Dr. Merino: That’s a big challenge that has come with this whole idea of open access and the fact that now, many journals are online only, so you’re no longer seeing a physical copy. That has given rise to the predatory journals.
The predatory journal, by definition, is a journal that claims to be open access. They’ll take your paper and publish it, but they don’t provide all the other services that you would typically expect from the fact that you’re paying an open-access fee. This includes getting appropriate peer review, production of the manuscript, and long-term curation and storage of the manuscript.
Many predatory journals will take your open-access fee, accept any paper that you submit, regardless of the quality, because they’re charging the fees for that. They don’t send it to real peer review, and then in a few months, the journal disappears so there’s no way for anybody to actually find your paper anymore.
There are certain checklists. Dr. David Moher at the University of Toronto has produced some work trying to help us identify predatory journals.
One thing I typically suggest to people who ask me this question is: Have you ever heard of this journal before? Does the journal have a track record? How far back does the story of the journal go? Is it supported by a publisher that you know? Do you know anybody who has published there? Is it something you can easily access?
If in doubt, always ask your friendly medical librarian. There used to be lists that were kept in terms of predatory journals that were being constantly updated, but those had to be shut down. As far as I understand, there were legal issues in terms of how things got on that list.
I think that overall, if you’ve heard of it, if it’s relevant, if it’s known in your field, and if your librarian knows it, it’s probably a good legitimate open-access journal. There are many very good legitimate open-access journals.
I mentioned the two that we have in our family, but all the other major journals have their own open-access journal within their family. There are some, like BMC or PLOS, that are completely open-access and legitimate journals.
Impact Factor
Dr. Wilner: What about impact factor? Many journals boast about their impact factor. I’m not sure how to interpret that number.
Dr. Merino: Impact factor is very interesting. The impact factor was developed by medical librarians to try to identify the journals they should be subscribing to. It’s a measure of the average citations to an average paper in the journal.
It doesn’t tell you about specific papers. It tells you, on average, how many of the papers in this journal get cited so many times. It’s calculated by the number of articles that were cited divided by the number of articles that were published. Journals that publish many papers, like Neurology, have a hard time bringing up their impact factor beyond a certain level.
Similarly, very small journals with one or two very highly cited papers have a very high impact factor. It’s being used as a measure, perhaps inappropriately, of how good or how reputable a journal is. We all say we don’t care about journal impact factors, but we all know our journal impact factor and we used to know it to three decimals. Now, they changed the system, and there’s only one decimal point, which makes more sense.
This is more important, for example, for authors when deciding where to submit papers. I know that in some countries, particularly in Europe, the impact factor of the journal where you publish has an impact on your promotion decisions.
I would say what’s even more important than the impact factor, is to say, “Well, is this the journal that fits the scope of my paper? Is this the journal that reaches the audience that I want to reach when I write my paper?”
There are some papers, for example, that are very influential. The impact factor just captures citations. There are some papers that are very influential that may not get cited very often. There may be papers that change clinical practice.
If you read a paper that tells you that you should be changing how you treat your patients with myasthenia based on this paper, that may not get cited. It’s a very clinically focused paper, but it’s probably more impactful than one that gets cited very much in some respect, or they make it to public policy decisions, and so on.
I think it’s important to look more at the audience and the journal scope when you submit your papers.
Dr. Wilner: One other technical question. The journals also say they’re indexed in PubMed or Google Scholar. If I want to publish my paper and I want it indexed where the right people are going to find it, where does it need to be indexed?
Dr. Merino: I grew up using Index Medicus, MedlinePlus, and the Library of Science. I still do. If I need to find something, I go to PubMed. Ideally, papers are listed in MedlinePlus or can be found in PubMed. They’re not the same thing, but you can find them through them.
That would be an important thing. Nowadays, a lot more people are using Google Scholar or Google just to identify papers. It may be a little bit less relevant, but it’s still a measure of the quality of the journal before they get indexed in some of these. For example, if you get listed in MedlinePlus, it has gone through certain quality checks by the index itself to see whether they would accept the journal or not. That’s something you want to check.
Typically, most of the large journals or the journals you and I know about are listed in more than one place, right? They’re listed in Scopus and Web of Science. They’re listed in MedlinePlus and so on. Again, if you’re submitting your paper, go somewhere where you know the journal and you’ve heard about it.
Dr. Wilner: I’m not going to ask you about artificial intelligence. We can do that another time. I want to ask something closer to me, which is this question of publish or perish.
There seems to be, in academics, more emphasis on the number of papers that one has published rather than their quality. How does a younger academician or one who really needs to publish cope with that?
Dr. Merino: Many people are writing up research that may not be relevant or that may not be high quality just because you need to have a long list of papers to get promoted, for example, if you’re an academician.
Doug Altman, who was a very influential person in the field quality of not only medical statistics but also medical publishing, had the idea that we need less research, but we need better research.
We often receive papers where you say, well, what’s the rationale behind the question in this paper? It’s like they had a large amount of data and were trying to squeeze as much as they could out of that. I think, as a young academician, the important thing to think about is whether it is an important question that matters to you and to the field, from whatever perspective, whether it’s going to advance research, advance clinical care, or have public policy implications.
Is this one where the answer will be important no matter what the answer is? If you’re thinking of that, your work will be well recognized, people will know you, and you’ll get invited to collaborate. I think that’s the most important thing rather than just churning out a large number of papers.
The productivity will come from the fact that you start by saying, let me ask something that’s really meaningful to me and to the field, with a good question and using strong research methodology.
Dr. Wilner: Thanks for that, Dr. Merino. I think that’s very valuable for all of us. This has been a great discussion. Do you have any final comments before we wrap up?
Dr. Merino: I want to encourage people to continue reading medical journals all the time and submitting to us, again, good research and important questions with robust methodology. That’s what we’re looking for in Neurology and most serious medical journals.
Dr. Wilner is an associate professor of neurology at the University of Tennessee Health Science Center, Memphis. Dr. Merino is a professor in the department of neurology at Georgetown University Medical Center, Washington, DC. Dr. Wilner reported conflicts of interest with Accordant Health Services and Lulu Publishing. Dr. Merino reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Andrew N. Wilner, MD: My guest today is Dr. Jose Merino, editor in chief of the Neurology family of journals and professor of neurology and co-vice chair of education at Georgetown University in Washington, DC.
Our program today is a follow-up of Dr. Merino’s presentation at the recent American Academy of Neurology meeting in Denver, Colorado. Along with two other panelists, Dr. Merino discussed the role of open-access publication and the dangers of predatory journals.
Jose G. Merino, MD, MPhil: Thank you for having me here. It’s a pleasure.
Open Access Defined
Dr. Wilner: I remember when publication in neurology was pretty straightforward. It was either the green journal or the blue journal, but things have certainly changed. I think one topic that is not clear to everyone is this concept of open access. Could you define that for us?
Dr. Merino: Sure. Open access is a mode of publication that fosters more open or accessible science. The idea of open access is that it combines two main elements. One is that the papers that are published become immediately available to anybody with an internet connection anywhere in the world without any restrictions.
The second important element from open access, which makes it different from other models we can talk about, is the fact that the authors retain the copyright of their work, but they give the journal and readers a license to use, reproduce, and modify the content.
This is different, for example, from instances where we have funder mandates. For example, NIH papers have to become available 6 months after publication, so they’re available to everybody but not immediately.
Dr. Wilner: I remember that when a journal article was published, say, in Neurology, if you didn’t have a subscription to Neurology, you went to the library that hopefully had a subscription.
If they didn’t have it, you would write to the author and say, “Hey, I heard you have this great paper because the abstract was out there. Could you send me a reprint?” Has that whole universe evaporated?
Dr. Merino: It depends on how the paper is published. For example, in Neurology, some of the research we publish is open access. Basically, if you have an internet connection, you can access the paper.
That’s the case for papers published in our wholly open-access journals in the Neurology family like Neurology Neuroimmunology & Neuroinflammation, Neurology Genetics, or Neurology Education.
For other papers that are published in Neurology, not under open access, there is a paywall. For some of them, the paywall comes down after a few months based on funder mandates and so on. As I was mentioning, the NIH-funded papers are available 6 months later.
In the first 6 months, you may have to go to your library, and if your library has a subscription, you can download it directly. [This is also true for] those that always stay behind the paywall, where you have to have a subscription or your library has to have a subscription.
Is Pay to Publish a Red Flag?
Dr. Wilner: I’m a professional writer. With any luck, when I write something, I get paid to write it. There’s been a long tradition in academic medicine that when you submit an article to, say, Neurology, you don’t get paid as an author for the publication. Your reward is the honor of it being published.
Neurology supports itself in various ways, including advertising and so on. That’s been the contract: free publication for work that merits it, and the journal survives on its own.
With open access, one of the things that’s happened is that — and I’ve published open access myself — is that I get a notification that I need to pay to have my article that I’ve slaved over published. Explain that, please.
Dr. Merino: This is the issue with open access. As I mentioned, the paper gets published. You’re giving the journal a license to publish it. You’re retaining the copyright of your work. That means that the journal cannot make money or support itself by just publishing open access because they belong to you.
Typically, open-access journals are not in print and don’t have much in terms of advertising. The contract is you’re giving me a license to publish it, but it’s your journal, so you’re paying a fee for the journal expenses to basically produce your paper. That’s what’s happening with open access.
That’s been recognized with many funders, for example, with NIH funding or many of the European funders, they’re including open-access fees as part of their funding for research. Now, of course, this doesn’t help if you’re not a funded researcher or if you’re a fellow who’s doing work and so on.
Typically, most journals will have waived fees or lower fees for these situations. The reason for the open-access fee is the fact that you’re retaining the copyright. You’re not giving it to the journal who can then use it to generate its revenue for supporting itself, the editorial staff, and so on.
Dr. Wilner: This idea of charging for publication has created a satellite business of what are called predatory journals. How does one know if the open-access journal that I’m submitting to is really just in the business of wanting my $300 or my $900 to get published? How do I know if that’s a reasonable place to publish?
Predatory Journals
Dr. Merino: That’s a big challenge that has come with this whole idea of open access and the fact that now, many journals are online only, so you’re no longer seeing a physical copy. That has given rise to the predatory journals.
The predatory journal, by definition, is a journal that claims to be open access. They’ll take your paper and publish it, but they don’t provide all the other services that you would typically expect from the fact that you’re paying an open-access fee. This includes getting appropriate peer review, production of the manuscript, and long-term curation and storage of the manuscript.
Many predatory journals will take your open-access fee, accept any paper that you submit, regardless of the quality, because they’re charging the fees for that. They don’t send it to real peer review, and then in a few months, the journal disappears so there’s no way for anybody to actually find your paper anymore.
There are certain checklists. Dr. David Moher at the University of Toronto has produced some work trying to help us identify predatory journals.
One thing I typically suggest to people who ask me this question is: Have you ever heard of this journal before? Does the journal have a track record? How far back does the story of the journal go? Is it supported by a publisher that you know? Do you know anybody who has published there? Is it something you can easily access?
If in doubt, always ask your friendly medical librarian. There used to be lists that were kept in terms of predatory journals that were being constantly updated, but those had to be shut down. As far as I understand, there were legal issues in terms of how things got on that list.
I think that overall, if you’ve heard of it, if it’s relevant, if it’s known in your field, and if your librarian knows it, it’s probably a good legitimate open-access journal. There are many very good legitimate open-access journals.
I mentioned the two that we have in our family, but all the other major journals have their own open-access journal within their family. There are some, like BMC or PLOS, that are completely open-access and legitimate journals.
Impact Factor
Dr. Wilner: What about impact factor? Many journals boast about their impact factor. I’m not sure how to interpret that number.
Dr. Merino: Impact factor is very interesting. The impact factor was developed by medical librarians to try to identify the journals they should be subscribing to. It’s a measure of the average citations to an average paper in the journal.
It doesn’t tell you about specific papers. It tells you, on average, how many of the papers in this journal get cited so many times. It’s calculated by the number of articles that were cited divided by the number of articles that were published. Journals that publish many papers, like Neurology, have a hard time bringing up their impact factor beyond a certain level.
Similarly, very small journals with one or two very highly cited papers have a very high impact factor. It’s being used as a measure, perhaps inappropriately, of how good or how reputable a journal is. We all say we don’t care about journal impact factors, but we all know our journal impact factor and we used to know it to three decimals. Now, they changed the system, and there’s only one decimal point, which makes more sense.
This is more important, for example, for authors when deciding where to submit papers. I know that in some countries, particularly in Europe, the impact factor of the journal where you publish has an impact on your promotion decisions.
I would say what’s even more important than the impact factor, is to say, “Well, is this the journal that fits the scope of my paper? Is this the journal that reaches the audience that I want to reach when I write my paper?”
There are some papers, for example, that are very influential. The impact factor just captures citations. There are some papers that are very influential that may not get cited very often. There may be papers that change clinical practice.
If you read a paper that tells you that you should be changing how you treat your patients with myasthenia based on this paper, that may not get cited. It’s a very clinically focused paper, but it’s probably more impactful than one that gets cited very much in some respect, or they make it to public policy decisions, and so on.
I think it’s important to look more at the audience and the journal scope when you submit your papers.
Dr. Wilner: One other technical question. The journals also say they’re indexed in PubMed or Google Scholar. If I want to publish my paper and I want it indexed where the right people are going to find it, where does it need to be indexed?
Dr. Merino: I grew up using Index Medicus, MedlinePlus, and the Library of Science. I still do. If I need to find something, I go to PubMed. Ideally, papers are listed in MedlinePlus or can be found in PubMed. They’re not the same thing, but you can find them through them.
That would be an important thing. Nowadays, a lot more people are using Google Scholar or Google just to identify papers. It may be a little bit less relevant, but it’s still a measure of the quality of the journal before they get indexed in some of these. For example, if you get listed in MedlinePlus, it has gone through certain quality checks by the index itself to see whether they would accept the journal or not. That’s something you want to check.
Typically, most of the large journals or the journals you and I know about are listed in more than one place, right? They’re listed in Scopus and Web of Science. They’re listed in MedlinePlus and so on. Again, if you’re submitting your paper, go somewhere where you know the journal and you’ve heard about it.
Dr. Wilner: I’m not going to ask you about artificial intelligence. We can do that another time. I want to ask something closer to me, which is this question of publish or perish.
There seems to be, in academics, more emphasis on the number of papers that one has published rather than their quality. How does a younger academician or one who really needs to publish cope with that?
Dr. Merino: Many people are writing up research that may not be relevant or that may not be high quality just because you need to have a long list of papers to get promoted, for example, if you’re an academician.
Doug Altman, who was a very influential person in the field quality of not only medical statistics but also medical publishing, had the idea that we need less research, but we need better research.
We often receive papers where you say, well, what’s the rationale behind the question in this paper? It’s like they had a large amount of data and were trying to squeeze as much as they could out of that. I think, as a young academician, the important thing to think about is whether it is an important question that matters to you and to the field, from whatever perspective, whether it’s going to advance research, advance clinical care, or have public policy implications.
Is this one where the answer will be important no matter what the answer is? If you’re thinking of that, your work will be well recognized, people will know you, and you’ll get invited to collaborate. I think that’s the most important thing rather than just churning out a large number of papers.
The productivity will come from the fact that you start by saying, let me ask something that’s really meaningful to me and to the field, with a good question and using strong research methodology.
Dr. Wilner: Thanks for that, Dr. Merino. I think that’s very valuable for all of us. This has been a great discussion. Do you have any final comments before we wrap up?
Dr. Merino: I want to encourage people to continue reading medical journals all the time and submitting to us, again, good research and important questions with robust methodology. That’s what we’re looking for in Neurology and most serious medical journals.
Dr. Wilner is an associate professor of neurology at the University of Tennessee Health Science Center, Memphis. Dr. Merino is a professor in the department of neurology at Georgetown University Medical Center, Washington, DC. Dr. Wilner reported conflicts of interest with Accordant Health Services and Lulu Publishing. Dr. Merino reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Andrew N. Wilner, MD: My guest today is Dr. Jose Merino, editor in chief of the Neurology family of journals and professor of neurology and co-vice chair of education at Georgetown University in Washington, DC.
Our program today is a follow-up of Dr. Merino’s presentation at the recent American Academy of Neurology meeting in Denver, Colorado. Along with two other panelists, Dr. Merino discussed the role of open-access publication and the dangers of predatory journals.
Jose G. Merino, MD, MPhil: Thank you for having me here. It’s a pleasure.
Open Access Defined
Dr. Wilner: I remember when publication in neurology was pretty straightforward. It was either the green journal or the blue journal, but things have certainly changed. I think one topic that is not clear to everyone is this concept of open access. Could you define that for us?
Dr. Merino: Sure. Open access is a mode of publication that fosters more open or accessible science. The idea of open access is that it combines two main elements. One is that the papers that are published become immediately available to anybody with an internet connection anywhere in the world without any restrictions.
The second important element from open access, which makes it different from other models we can talk about, is the fact that the authors retain the copyright of their work, but they give the journal and readers a license to use, reproduce, and modify the content.
This is different, for example, from instances where we have funder mandates. For example, NIH papers have to become available 6 months after publication, so they’re available to everybody but not immediately.
Dr. Wilner: I remember that when a journal article was published, say, in Neurology, if you didn’t have a subscription to Neurology, you went to the library that hopefully had a subscription.
If they didn’t have it, you would write to the author and say, “Hey, I heard you have this great paper because the abstract was out there. Could you send me a reprint?” Has that whole universe evaporated?
Dr. Merino: It depends on how the paper is published. For example, in Neurology, some of the research we publish is open access. Basically, if you have an internet connection, you can access the paper.
That’s the case for papers published in our wholly open-access journals in the Neurology family like Neurology Neuroimmunology & Neuroinflammation, Neurology Genetics, or Neurology Education.
For other papers that are published in Neurology, not under open access, there is a paywall. For some of them, the paywall comes down after a few months based on funder mandates and so on. As I was mentioning, the NIH-funded papers are available 6 months later.
In the first 6 months, you may have to go to your library, and if your library has a subscription, you can download it directly. [This is also true for] those that always stay behind the paywall, where you have to have a subscription or your library has to have a subscription.
Is Pay to Publish a Red Flag?
Dr. Wilner: I’m a professional writer. With any luck, when I write something, I get paid to write it. There’s been a long tradition in academic medicine that when you submit an article to, say, Neurology, you don’t get paid as an author for the publication. Your reward is the honor of it being published.
Neurology supports itself in various ways, including advertising and so on. That’s been the contract: free publication for work that merits it, and the journal survives on its own.
With open access, one of the things that’s happened is that — and I’ve published open access myself — is that I get a notification that I need to pay to have my article that I’ve slaved over published. Explain that, please.
Dr. Merino: This is the issue with open access. As I mentioned, the paper gets published. You’re giving the journal a license to publish it. You’re retaining the copyright of your work. That means that the journal cannot make money or support itself by just publishing open access because they belong to you.
Typically, open-access journals are not in print and don’t have much in terms of advertising. The contract is you’re giving me a license to publish it, but it’s your journal, so you’re paying a fee for the journal expenses to basically produce your paper. That’s what’s happening with open access.
That’s been recognized with many funders, for example, with NIH funding or many of the European funders, they’re including open-access fees as part of their funding for research. Now, of course, this doesn’t help if you’re not a funded researcher or if you’re a fellow who’s doing work and so on.
Typically, most journals will have waived fees or lower fees for these situations. The reason for the open-access fee is the fact that you’re retaining the copyright. You’re not giving it to the journal who can then use it to generate its revenue for supporting itself, the editorial staff, and so on.
Dr. Wilner: This idea of charging for publication has created a satellite business of what are called predatory journals. How does one know if the open-access journal that I’m submitting to is really just in the business of wanting my $300 or my $900 to get published? How do I know if that’s a reasonable place to publish?
Predatory Journals
Dr. Merino: That’s a big challenge that has come with this whole idea of open access and the fact that now, many journals are online only, so you’re no longer seeing a physical copy. That has given rise to the predatory journals.
The predatory journal, by definition, is a journal that claims to be open access. They’ll take your paper and publish it, but they don’t provide all the other services that you would typically expect from the fact that you’re paying an open-access fee. This includes getting appropriate peer review, production of the manuscript, and long-term curation and storage of the manuscript.
Many predatory journals will take your open-access fee, accept any paper that you submit, regardless of the quality, because they’re charging the fees for that. They don’t send it to real peer review, and then in a few months, the journal disappears so there’s no way for anybody to actually find your paper anymore.
There are certain checklists. Dr. David Moher at the University of Toronto has produced some work trying to help us identify predatory journals.
One thing I typically suggest to people who ask me this question is: Have you ever heard of this journal before? Does the journal have a track record? How far back does the story of the journal go? Is it supported by a publisher that you know? Do you know anybody who has published there? Is it something you can easily access?
If in doubt, always ask your friendly medical librarian. There used to be lists that were kept in terms of predatory journals that were being constantly updated, but those had to be shut down. As far as I understand, there were legal issues in terms of how things got on that list.
I think that overall, if you’ve heard of it, if it’s relevant, if it’s known in your field, and if your librarian knows it, it’s probably a good legitimate open-access journal. There are many very good legitimate open-access journals.
I mentioned the two that we have in our family, but all the other major journals have their own open-access journal within their family. There are some, like BMC or PLOS, that are completely open-access and legitimate journals.
Impact Factor
Dr. Wilner: What about impact factor? Many journals boast about their impact factor. I’m not sure how to interpret that number.
Dr. Merino: Impact factor is very interesting. The impact factor was developed by medical librarians to try to identify the journals they should be subscribing to. It’s a measure of the average citations to an average paper in the journal.
It doesn’t tell you about specific papers. It tells you, on average, how many of the papers in this journal get cited so many times. It’s calculated by the number of articles that were cited divided by the number of articles that were published. Journals that publish many papers, like Neurology, have a hard time bringing up their impact factor beyond a certain level.
Similarly, very small journals with one or two very highly cited papers have a very high impact factor. It’s being used as a measure, perhaps inappropriately, of how good or how reputable a journal is. We all say we don’t care about journal impact factors, but we all know our journal impact factor and we used to know it to three decimals. Now, they changed the system, and there’s only one decimal point, which makes more sense.
This is more important, for example, for authors when deciding where to submit papers. I know that in some countries, particularly in Europe, the impact factor of the journal where you publish has an impact on your promotion decisions.
I would say what’s even more important than the impact factor, is to say, “Well, is this the journal that fits the scope of my paper? Is this the journal that reaches the audience that I want to reach when I write my paper?”
There are some papers, for example, that are very influential. The impact factor just captures citations. There are some papers that are very influential that may not get cited very often. There may be papers that change clinical practice.
If you read a paper that tells you that you should be changing how you treat your patients with myasthenia based on this paper, that may not get cited. It’s a very clinically focused paper, but it’s probably more impactful than one that gets cited very much in some respect, or they make it to public policy decisions, and so on.
I think it’s important to look more at the audience and the journal scope when you submit your papers.
Dr. Wilner: One other technical question. The journals also say they’re indexed in PubMed or Google Scholar. If I want to publish my paper and I want it indexed where the right people are going to find it, where does it need to be indexed?
Dr. Merino: I grew up using Index Medicus, MedlinePlus, and the Library of Science. I still do. If I need to find something, I go to PubMed. Ideally, papers are listed in MedlinePlus or can be found in PubMed. They’re not the same thing, but you can find them through them.
That would be an important thing. Nowadays, a lot more people are using Google Scholar or Google just to identify papers. It may be a little bit less relevant, but it’s still a measure of the quality of the journal before they get indexed in some of these. For example, if you get listed in MedlinePlus, it has gone through certain quality checks by the index itself to see whether they would accept the journal or not. That’s something you want to check.
Typically, most of the large journals or the journals you and I know about are listed in more than one place, right? They’re listed in Scopus and Web of Science. They’re listed in MedlinePlus and so on. Again, if you’re submitting your paper, go somewhere where you know the journal and you’ve heard about it.
Dr. Wilner: I’m not going to ask you about artificial intelligence. We can do that another time. I want to ask something closer to me, which is this question of publish or perish.
There seems to be, in academics, more emphasis on the number of papers that one has published rather than their quality. How does a younger academician or one who really needs to publish cope with that?
Dr. Merino: Many people are writing up research that may not be relevant or that may not be high quality just because you need to have a long list of papers to get promoted, for example, if you’re an academician.
Doug Altman, who was a very influential person in the field quality of not only medical statistics but also medical publishing, had the idea that we need less research, but we need better research.
We often receive papers where you say, well, what’s the rationale behind the question in this paper? It’s like they had a large amount of data and were trying to squeeze as much as they could out of that. I think, as a young academician, the important thing to think about is whether it is an important question that matters to you and to the field, from whatever perspective, whether it’s going to advance research, advance clinical care, or have public policy implications.
Is this one where the answer will be important no matter what the answer is? If you’re thinking of that, your work will be well recognized, people will know you, and you’ll get invited to collaborate. I think that’s the most important thing rather than just churning out a large number of papers.
The productivity will come from the fact that you start by saying, let me ask something that’s really meaningful to me and to the field, with a good question and using strong research methodology.
Dr. Wilner: Thanks for that, Dr. Merino. I think that’s very valuable for all of us. This has been a great discussion. Do you have any final comments before we wrap up?
Dr. Merino: I want to encourage people to continue reading medical journals all the time and submitting to us, again, good research and important questions with robust methodology. That’s what we’re looking for in Neurology and most serious medical journals.
Dr. Wilner is an associate professor of neurology at the University of Tennessee Health Science Center, Memphis. Dr. Merino is a professor in the department of neurology at Georgetown University Medical Center, Washington, DC. Dr. Wilner reported conflicts of interest with Accordant Health Services and Lulu Publishing. Dr. Merino reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.