Rheumatology News

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

Should a hospital or medical practice fulfill a patient’s request to be treated or cared for only by vaccinated health care providers?The answer is yes, in a perfect world. Patients should feel assured that their health care providers – clinicians and caregivers – are not exposing them to infectious diseases.But issues are being raised – subquestions that need to be answered to understand the current situation and assist health care employers in their decision-making:

• Must health care employers ensure that their employees are vaccinated?
• Can health care employers require that their employees be vaccinated?
• Do employees have any rights to refuse vaccination or to refuse to supply their employer with their vaccination status?
• Can a health care employer terminate an employee who refuses vaccination?
• Does a patient have a legal right to a vaccinated health care provider?

At present, federal policy says that employers may, but are not required to, insist that employees be vaccinated. The currently prevailing state case law says that hospitals and other employers can require staff to be vaccinated and can terminate employees who refuse vaccination. In June, a Texas court dismissed a case in which 117 employees sued a hospital for requiring that employees be vaccinated. More cases are pending in other states, and there may be differing decisions in other states and on appeal.

State laws enacted years ago also weigh in on employer obligations. In at least one state, Oregon, employers of health care providers may not require vaccination, even though other employers may. Other states have laws about what an employer may or may not require of an employee regarding vaccination, and some have introduced laws which are pending.

So, in most states, health care employers may, not must, require that employees be vaccinated. In most states, hospitals and medical practices may terminate employees who refuse vaccination. However, employers should research the laws of their own states before requiring vaccinations and before terminating employees who are not vaccinated.

The issue of employer mandates is complicated further by the practicality that, in some areas of the country, health care providers are in scarce supply. Employers don’t want to lose the providers they have.

And there are additional questions about how certain federal laws affect the situation. Federal law that may apply includes:

• U.S. Food and Drug Administration regulation on approval of vaccines
• The Americans With Disabilities Act (ADA)
• The Health Insurance Portability and Accountability Act of 1996, which protects sensitive patient health information from being disclosed without the patient’s consent
• Civil rights laws
• Patients’ rights

FDA. Some health care providers who refuse vaccination argue that employers have no legal right to require a vaccine that is not fully approved by the FDA. COVID-19 vaccinations have emergency use authorization – something less than full approval. Courts have not yet ruled on this issue.

ADA. Some attorneys believe that honoring a patient’s request to be attended only by a vaccinated health care provider can implicate the ADA. However, the ADA doesn’t protect healthy individuals who don’t want to be vaccinated. The ADA protects the person who, because of their disability, shouldn’t get the vaccination. If an employer mandates vaccination, the employer must, under the ADA, consider requests for exemptions from disabled individuals. However, even when an employee has a disability that may qualify the employee for an exemption to the vaccination requirement, an employer may argue that giving an exemption would be a direct threat to the safety of others; in that case, the ADA may require that the disabled employee and hospital work something out. A compromise might be that the unvaccinated disabled individual would not provide direct patient care or would wear a mask and maintain physical distance.

HIPAA. Some argue that federal privacy law enters into the discussion, maintaining that health care employers can’t disclose employees’ vaccination status under HIPAA. That is not true. Employers are not “covered entities” under HIPAA. It is health care providers who are precluded under HIPAA from disclosing a patient’s personal information. So, if an employer were to ask an employee’s health care provider about the employee’s vaccination status, the health care provider could disclose that status only if the employee consented to the disclosure. An employer may ask an employee for the employee’s proof of vaccination card. However, employers must not ask for unnecessary details that might reveal disability information protected by the ADA.

Civil rights law. Civil rights laws may protect certain individuals from employment consequences of refusing vaccination. Specifically, individuals with sincerely held religious convictions against vaccinations are protected from retaliation by employers for refusing vaccination, under the Constitutional right of freedom of religion. The individual without sincerely held religious convictions against vaccinations and without a relevant disability doesn’t have legal remedies under civil rights laws.

Civil rights laws may apply if employers don’t apply their vaccination requirements to all employees equally. That is, employers can’t require vaccinations of some employees but not others.

Patients’ rights. Legal protections for patients who want a vaccinated health care provider are nowhere to be seen, at this time. It is unlikely that a single patient will be able to convince a hospital or medical practice to require that its staff be vaccinated. However, if a patient becomes infected with COVID-19 and can prove that the illness is causally related to interacting with an unvaccinated health care worker, the patient may have a case against the employer. The legal theory would be malpractice or negligence under informed consent law: That is, the patient did not consent to be treated by an unvaccinated person.
 

Employer options

So, what can health care employers do? They have three options:

• Require vaccination of all employees, independent contractors, and other providers who have privileges to see patients. Then, as long as the employer enforces the vaccination mandate, the employer can tell patients that all providers are vaccinated.
• Not require that employees and others with access to patients be vaccinated, and if a patient requests to be seen only by vaccinated providers, provide that patient with a vaccinated provider. It is especially important that health care employers take care with patients who are unvaccinated and who have been advised not to be vaccinated because of a medical condition. Both the patient and the health care employer would be protected best by avoiding having two unvaccinated individuals interact. Masks and physical distancing may decrease the risk.
• Not require that employees be vaccinated and refuse to guarantee that providers are vaccinated. To avoid risk for future lawsuits, employers should inform patients that there is no assurance that providers are vaccinated. That leaves it to each patient to ask individual providers about the provider’s vaccination status. If a patient doesn’t like a provider’s answer, then the patient has the right to leave. It’s not clear that the patient has a legal right to stay and demand a vaccinated provider.

Option three is problematic for a number of reasons. Patients aren’t always in a position to query each provider who enters the room about vaccination status. Patients may be sedated or too ill to exert that effort. And it puts supervisors in the position of having to mediate situations where a patient wants to leave against medical advice but the option of staying may also be dangerous.

Health care employers should discuss the options with their legal counsel before deciding which option to adopt.

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

I receive updates and stories every day from rheumatologists and their offices regarding the egregious behavior of various health care entities that profit off patients and harm them in the process. If you know me, you know I’m willing to tell and retell horror stories of pharmacy benefit managers (PBMs), especially of how they construct formularies for the most profit, again, harming patients in the process. It’s critical to serve as a voice to counter the PBM trade group, the Pharmaceutical Care Management Association, which continues to extol how PBMs are essentially saving our country billions ... one restrictive formulary at a time.

It does seem that we are constantly fighting against something:

• Patients arbitrarily being switched to completely different medications to “save” money. These “savings” are pocketed by the middlemen, not the patients or the employers paying for the coverage.
• Copay cards for medications that have no lower-cost alternative. These fill the coffers of the health plans without patients getting credit toward their deductible.
• Mandating that patients move from receiving their infusions under the watchful eye of their rheumatologist’s office to home infusion. This has been shown to be more dangerous for our patients.
• Wasting hours on prior authorization paperwork for needed medication. We know that these are nearly always approved, and thereby delay treatment unnecessarily.

By now you might wonder: “Where is the good news?” In spite of the daily barrage of battles that come our way, rheumatologists continue to do good and improve the lives of our patients. I would go as far as to say that we are prospering in spite of the challenges. Why? Because every day there are wins. Seeing that smile for the first time on the face of a patient who finally has answers and a treatment plan for their newly diagnosed RA. Walking out of the exam room and having patients and their parents give you a hug. Helping a dad be able to walk his daughter down the aisle with ease. On the clinical front, I don’t have to tell you: We score wins every single day.

There is good news on the advocacy side, too. In my own state of Louisiana, this legislative session, we passed a number of bills that are beneficial to our patients, including a bill to stop the aforementioned attacks on copay assistance by state regulated payers. We even blocked one that the Rheumatology Alliance of Louisiana felt would be harmful to our patients. The wins this session follow wins during the previous session, including passage of new and updated laws to put more prescribing power back in the hands of physicians when medication access is unnecessarily restricted by step therapy. While there has been some doubt as to whether these state laws actually work, I can attest that the new Louisiana step therapy law has allowed stable patients to remain on their medication in a number of specialties, including rheumatology and ophthalmology.

My own state of Louisiana is not the only one where the rheumatology community has seen legislative successes, and that speaks to the strength of the network that rheumatologists have built within their states and across the country, as well as our passion for our patients. Just 3 years after the emergence of accumulator programs, 11 states have already seen fit to curtail their use (Arizona, Arkansas, Connecticut, Georgia, Illinois, Kentucky, Louisiana, Oklahoma, Tennessee, Virginia, and West Virginia), and over 20 states considered adopting similar legislation this year. Reforms to the use of step therapy continue their drumbeat across the country, with three more states (Arkansas, Nebraska, and Oregon) having bills signed into law this year. West Virginia took a bold step to reduce patient out-of-pocket costs at the point of sale by an amount commensurate with 100% of rebates received by a PBM. These material policy wins demonstrate how we continue to successfully chip away at the opacity of PBMs and the rebate system, which is truly at the root of so many of the issues affecting our patients’ care.

At the federal level, rheumatologists engage both with Congress and the administration to ensure that our patients’ voices are represented against very well funded and organized forces like insurers and PBMs. Rheumatologists weighed in on issues ranging from Medicaid payment policy, to copay accumulators in the exchanges, to creating transparency and fixing misaligned incentives in the pharmaceutical supply chain. We drive coalition engagement on issues of shared interest with other specialty and provider groups, such as extending a moratorium on Medicare sequestration. We also engage on narrow issues as they arise: For example, I personally testified before Congress that any proposed limitations on pharmaceutical samples must consider the fact that these samples can provide a critical bridge for patients waiting for their insurers to approve their needed medication. And, perhaps most importantly, we have defeated misguided and potentially devastating Part B payment reform models from the Innovation Center three separate times.

There is more work to be done. And to make it easier to find “Rheum for Action” in your daily work, the Coalition of State Rheumatology Organizations has tools on our website that summarize legislation and facilitate engagement with policy makers, including thank you messages to those who supported our priorities to celebrate the good news this year.

So yes, there is good news now, and more to come! I am optimistic that we will continue to see these advocacy wins, which will help to ensure that those hugs we share with our patients will continue long into the future.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

I receive updates and stories every day from rheumatologists and their offices regarding the egregious behavior of various health care entities that profit off patients and harm them in the process. If you know me, you know I’m willing to tell and retell horror stories of pharmacy benefit managers (PBMs), especially of how they construct formularies for the most profit, again, harming patients in the process. It’s critical to serve as a voice to counter the PBM trade group, the Pharmaceutical Care Management Association, which continues to extol how PBMs are essentially saving our country billions ... one restrictive formulary at a time.

It does seem that we are constantly fighting against something:

• Patients arbitrarily being switched to completely different medications to “save” money. These “savings” are pocketed by the middlemen, not the patients or the employers paying for the coverage.
• Copay cards for medications that have no lower-cost alternative. These fill the coffers of the health plans without patients getting credit toward their deductible.
• Mandating that patients move from receiving their infusions under the watchful eye of their rheumatologist’s office to home infusion. This has been shown to be more dangerous for our patients.
• Wasting hours on prior authorization paperwork for needed medication. We know that these are nearly always approved, and thereby delay treatment unnecessarily.

By now you might wonder: “Where is the good news?” In spite of the daily barrage of battles that come our way, rheumatologists continue to do good and improve the lives of our patients. I would go as far as to say that we are prospering in spite of the challenges. Why? Because every day there are wins. Seeing that smile for the first time on the face of a patient who finally has answers and a treatment plan for their newly diagnosed RA. Walking out of the exam room and having patients and their parents give you a hug. Helping a dad be able to walk his daughter down the aisle with ease. On the clinical front, I don’t have to tell you: We score wins every single day.

There is good news on the advocacy side, too. In my own state of Louisiana, this legislative session, we passed a number of bills that are beneficial to our patients, including a bill to stop the aforementioned attacks on copay assistance by state regulated payers. We even blocked one that the Rheumatology Alliance of Louisiana felt would be harmful to our patients. The wins this session follow wins during the previous session, including passage of new and updated laws to put more prescribing power back in the hands of physicians when medication access is unnecessarily restricted by step therapy. While there has been some doubt as to whether these state laws actually work, I can attest that the new Louisiana step therapy law has allowed stable patients to remain on their medication in a number of specialties, including rheumatology and ophthalmology.

My own state of Louisiana is not the only one where the rheumatology community has seen legislative successes, and that speaks to the strength of the network that rheumatologists have built within their states and across the country, as well as our passion for our patients. Just 3 years after the emergence of accumulator programs, 11 states have already seen fit to curtail their use (Arizona, Arkansas, Connecticut, Georgia, Illinois, Kentucky, Louisiana, Oklahoma, Tennessee, Virginia, and West Virginia), and over 20 states considered adopting similar legislation this year. Reforms to the use of step therapy continue their drumbeat across the country, with three more states (Arkansas, Nebraska, and Oregon) having bills signed into law this year. West Virginia took a bold step to reduce patient out-of-pocket costs at the point of sale by an amount commensurate with 100% of rebates received by a PBM. These material policy wins demonstrate how we continue to successfully chip away at the opacity of PBMs and the rebate system, which is truly at the root of so many of the issues affecting our patients’ care.

At the federal level, rheumatologists engage both with Congress and the administration to ensure that our patients’ voices are represented against very well funded and organized forces like insurers and PBMs. Rheumatologists weighed in on issues ranging from Medicaid payment policy, to copay accumulators in the exchanges, to creating transparency and fixing misaligned incentives in the pharmaceutical supply chain. We drive coalition engagement on issues of shared interest with other specialty and provider groups, such as extending a moratorium on Medicare sequestration. We also engage on narrow issues as they arise: For example, I personally testified before Congress that any proposed limitations on pharmaceutical samples must consider the fact that these samples can provide a critical bridge for patients waiting for their insurers to approve their needed medication. And, perhaps most importantly, we have defeated misguided and potentially devastating Part B payment reform models from the Innovation Center three separate times.

There is more work to be done. And to make it easier to find “Rheum for Action” in your daily work, the Coalition of State Rheumatology Organizations has tools on our website that summarize legislation and facilitate engagement with policy makers, including thank you messages to those who supported our priorities to celebrate the good news this year.

So yes, there is good news now, and more to come! I am optimistic that we will continue to see these advocacy wins, which will help to ensure that those hugs we share with our patients will continue long into the future.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

I receive updates and stories every day from rheumatologists and their offices regarding the egregious behavior of various health care entities that profit off patients and harm them in the process. If you know me, you know I’m willing to tell and retell horror stories of pharmacy benefit managers (PBMs), especially of how they construct formularies for the most profit, again, harming patients in the process. It’s critical to serve as a voice to counter the PBM trade group, the Pharmaceutical Care Management Association, which continues to extol how PBMs are essentially saving our country billions ... one restrictive formulary at a time.

It does seem that we are constantly fighting against something:

• Patients arbitrarily being switched to completely different medications to “save” money. These “savings” are pocketed by the middlemen, not the patients or the employers paying for the coverage.
• Copay cards for medications that have no lower-cost alternative. These fill the coffers of the health plans without patients getting credit toward their deductible.
• Mandating that patients move from receiving their infusions under the watchful eye of their rheumatologist’s office to home infusion. This has been shown to be more dangerous for our patients.
• Wasting hours on prior authorization paperwork for needed medication. We know that these are nearly always approved, and thereby delay treatment unnecessarily.

By now you might wonder: “Where is the good news?” In spite of the daily barrage of battles that come our way, rheumatologists continue to do good and improve the lives of our patients. I would go as far as to say that we are prospering in spite of the challenges. Why? Because every day there are wins. Seeing that smile for the first time on the face of a patient who finally has answers and a treatment plan for their newly diagnosed RA. Walking out of the exam room and having patients and their parents give you a hug. Helping a dad be able to walk his daughter down the aisle with ease. On the clinical front, I don’t have to tell you: We score wins every single day.

There is good news on the advocacy side, too. In my own state of Louisiana, this legislative session, we passed a number of bills that are beneficial to our patients, including a bill to stop the aforementioned attacks on copay assistance by state regulated payers. We even blocked one that the Rheumatology Alliance of Louisiana felt would be harmful to our patients. The wins this session follow wins during the previous session, including passage of new and updated laws to put more prescribing power back in the hands of physicians when medication access is unnecessarily restricted by step therapy. While there has been some doubt as to whether these state laws actually work, I can attest that the new Louisiana step therapy law has allowed stable patients to remain on their medication in a number of specialties, including rheumatology and ophthalmology.

My own state of Louisiana is not the only one where the rheumatology community has seen legislative successes, and that speaks to the strength of the network that rheumatologists have built within their states and across the country, as well as our passion for our patients. Just 3 years after the emergence of accumulator programs, 11 states have already seen fit to curtail their use (Arizona, Arkansas, Connecticut, Georgia, Illinois, Kentucky, Louisiana, Oklahoma, Tennessee, Virginia, and West Virginia), and over 20 states considered adopting similar legislation this year. Reforms to the use of step therapy continue their drumbeat across the country, with three more states (Arkansas, Nebraska, and Oregon) having bills signed into law this year. West Virginia took a bold step to reduce patient out-of-pocket costs at the point of sale by an amount commensurate with 100% of rebates received by a PBM. These material policy wins demonstrate how we continue to successfully chip away at the opacity of PBMs and the rebate system, which is truly at the root of so many of the issues affecting our patients’ care.

At the federal level, rheumatologists engage both with Congress and the administration to ensure that our patients’ voices are represented against very well funded and organized forces like insurers and PBMs. Rheumatologists weighed in on issues ranging from Medicaid payment policy, to copay accumulators in the exchanges, to creating transparency and fixing misaligned incentives in the pharmaceutical supply chain. We drive coalition engagement on issues of shared interest with other specialty and provider groups, such as extending a moratorium on Medicare sequestration. We also engage on narrow issues as they arise: For example, I personally testified before Congress that any proposed limitations on pharmaceutical samples must consider the fact that these samples can provide a critical bridge for patients waiting for their insurers to approve their needed medication. And, perhaps most importantly, we have defeated misguided and potentially devastating Part B payment reform models from the Innovation Center three separate times.

There is more work to be done. And to make it easier to find “Rheum for Action” in your daily work, the Coalition of State Rheumatology Organizations has tools on our website that summarize legislation and facilitate engagement with policy makers, including thank you messages to those who supported our priorities to celebrate the good news this year.

So yes, there is good news now, and more to come! I am optimistic that we will continue to see these advocacy wins, which will help to ensure that those hugs we share with our patients will continue long into the future.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at rhnews@mdedge.com.

Statins are associated with a low risk of adverse events in patients without a history of heart disease, but the potential harms are small and should not deter their use in primary prevention, a new systematic review and meta-analysis concludes.

RogerAshford/Thinkstock

As reported July 14 in BMJ, the analysis showed a slightly increased risk for self-reported muscle symptoms after treatment with statins but no increased risk for clinically confirmed muscle disorders. Statins were associated with liver dysfunction, renal insufficiency, and eye conditions, but not with diabetes.

“These risks are very, very small and, in fact, the adverse events we’re talking about are potentially quite mild, so if you weigh them against the benefits in terms of reduction in major cardiovascular events, the benefit-to-harm ratio is very much in favor of prescribing treatment for almost all patients,” senior author James P. Sheppard, MD, University of Oxford (England), said in an interview.

Although there’s an abundance of data showing that statins prevent recurrent cardiovascular events, their use is controversial in primary prevention, owing partly to the lower risk for cardiovascular disease (CVD). The absolute benefits of statins are smaller in primary prevention than in those with existing CVD, and the benefit-to-harm balance of treatment might be less favorable, the authors note.

A 2019 review suggested that the use of statins in primary prevention may be an example of “low-value care, having little benefit and potential to cause harm,” and a meta-analysis with more than 94,000 trial participants showed statins significantly increased risks for myopathy, renal dysfunction, and hepatic dysfunction.

Nevertheless, clinical guidelines have recommended wider use of statins for primary prevention, calling on physicians to weigh the benefits and harms.

“This is a reasonable expectation but, at present, the data on the harms of treatment are much less well understood in comparison to the benefits and there’s quite a lot of debate about the extent to which statins are associated with adverse events,” Dr. Sheppard said. “So we wanted to look at this in a bit more detail.”

The investigators analyzed results from 62 randomized controlled trials with 120,456 participants (mean age, 61; 40% women) followed for a mean of 3.9 years. All but two studies enrolled participants with hyperlipidemia or dyslipidemia. Common comorbidities were diabetes (11 studies), asymptomatic atherosclerosis (nine studies), and hypertension (four studies).

Statins increased risks for self-reported muscle symptoms in 21 trials (odds ratio [OR], 1.06), liver dysfunction in 21 trials (OR, 1.33), renal insufficiency in eight trials (OR, 1.14), and cataracts or other eye-related conditions in six trials (OR, 1.23).

At the same time, statins decreased risks for myocardial infarction in 22 trials (OR, 0.72), stroke in 17 trials (OR, 0.80), and CVD death in 22 trials (OR, 0.83).

These risks translated into 15 more events of muscle symptoms, 8 more liver events, 12 more kidney events, and 14 more eye conditions per 10,000 patients treated for a year.

Statins were estimated to prevent 19 myocardial infarctions, 9 strokes, and 8 CVD deaths per 10,000 patients treated for a year.

Dr. Sheppard suggested that the inclusion of previously omitted trials and the decision to classify muscle problems as self-reported symptoms or clinically defined muscle disorders based on changes in creatine kinase might explain why they found the association with statins, whereas most systematic reviews have not.

“Some people would argue that these side effects are so small and so negligible that we shouldn’t talk about them, but the problem with doing that is if you’ve got a patient who has a preconceived idea that statins are harmful,” he added. “So having some empirical data where you can actually say: ‘Look, just 15 people out of 10,000 patients who’ve been treated for a year might experience one of those self-reported muscle symptoms,’ hopefully, will be helpful for physicians having discussions in practice.”

The analysis is “another data point indicating the overall safety and net benefit of statins for patients, even in primary prevention,” Donald M. Lloyd-Jones, MD, ScM, chair of preventive medicine, Northwestern University, Chicago, said in an interview.

He noted that the renal insufficiency findings are difficult to interpret, given that the endpoint was defined as “any decline in renal function,” but that most will have been clinically unimportant. In general, most studies didn’t systematically look to ascertain some of adverse events but relied on participant or physician report. “Nonetheless, there is little reason to suspect bias in the collection of these data among the blinded studies.

“Although not definitive, given the study design and inclusion of very different types of studies and variable ascertainment of adverse events, the findings are reassuring that the risks of adverse events were small, and the potential adverse events identified were not very clinically significant and clearly outweighed by the important beneficial reductions in major cardiovascular events,” said Dr. Lloyd-Jones.

“This study is yet another reminder of the safety of statins,” Ann Marie Navar, MD, PhD, a specialist in preventive cardiology at UT Southwestern Medical School, Dallas, said in an email.

“I’m pleased to have a comprehensive study like this – a well-done, systematic review of randomized trials – to help combat the vast amounts of misinformation about statins circulating on the Internet.”

Dr. Lloyd-Jones also acknowledged the need to address misinformation, pointing out that the loss of contact with physicians and the adverse effects of the pandemic on weight and other health behaviors mean that many patients have had worsening of their cardiovascular risk factors.

“We must continue to help patients and the public understand that statins are beneficial for patients at sufficient risk for cardiovascular disease because of elevated cholesterol or their total burden of risk factors,” Dr. Lloyd-Jones said. “We must also be upfront about the risks of potential side effects, which are uncommon and almost always very easily managed with washout and dose reduction or switching to a different drug in the same class.”

Analyses by type of statin, however, showed few significant differences in adverse events. Rosuvastatin was associated with increased risks for self-reported muscle symptoms, renal insufficiency, diabetes, and eye conditions, whereas atorvastatin and lovastatin increased the risk for liver dysfunction.

In dose-response meta-analyses, a possible modest dose-response relationship was detected only for the effect of atorvastatin on liver dysfunction.

The current data do not support tailoring the type of statin or dosage to reduce adverse events, the authors say, although routine monitoring of liver function during treatment is probably warranted in primary prevention, given the increased risk for liver dysfunction.

To help improve adherence to statins, the investigators said, additional studies are needed to identify patient characteristics crucial to the small risks of adverse events.

Limitations of the research, they said, are that many of the analyses were underpowered to detect between-group differences, many trials had short periods of follow-up, and some trials excluded vulnerable people more likely to have adverse events, such as those with high serum creatinine.

The study was funded by a British Heart Foundation PhD Scholarship held by first author Ting Cai. Dr. Sheppard reports receiving funding from a Wellcome Trust/Royal Society Sir Henry Dale Fellowship. Disclosures for other authors are listed in the paper. Dr. Lloyd-Jones and Dr. Navar report having no conflicts of interest.

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

Statins are associated with a low risk of adverse events in patients without a history of heart disease, but the potential harms are small and should not deter their use in primary prevention, a new systematic review and meta-analysis concludes.

RogerAshford/Thinkstock

As reported July 14 in BMJ, the analysis showed a slightly increased risk for self-reported muscle symptoms after treatment with statins but no increased risk for clinically confirmed muscle disorders. Statins were associated with liver dysfunction, renal insufficiency, and eye conditions, but not with diabetes.

“These risks are very, very small and, in fact, the adverse events we’re talking about are potentially quite mild, so if you weigh them against the benefits in terms of reduction in major cardiovascular events, the benefit-to-harm ratio is very much in favor of prescribing treatment for almost all patients,” senior author James P. Sheppard, MD, University of Oxford (England), said in an interview.

Although there’s an abundance of data showing that statins prevent recurrent cardiovascular events, their use is controversial in primary prevention, owing partly to the lower risk for cardiovascular disease (CVD). The absolute benefits of statins are smaller in primary prevention than in those with existing CVD, and the benefit-to-harm balance of treatment might be less favorable, the authors note.

A 2019 review suggested that the use of statins in primary prevention may be an example of “low-value care, having little benefit and potential to cause harm,” and a meta-analysis with more than 94,000 trial participants showed statins significantly increased risks for myopathy, renal dysfunction, and hepatic dysfunction.

Nevertheless, clinical guidelines have recommended wider use of statins for primary prevention, calling on physicians to weigh the benefits and harms.

“This is a reasonable expectation but, at present, the data on the harms of treatment are much less well understood in comparison to the benefits and there’s quite a lot of debate about the extent to which statins are associated with adverse events,” Dr. Sheppard said. “So we wanted to look at this in a bit more detail.”

The investigators analyzed results from 62 randomized controlled trials with 120,456 participants (mean age, 61; 40% women) followed for a mean of 3.9 years. All but two studies enrolled participants with hyperlipidemia or dyslipidemia. Common comorbidities were diabetes (11 studies), asymptomatic atherosclerosis (nine studies), and hypertension (four studies).

Statins increased risks for self-reported muscle symptoms in 21 trials (odds ratio [OR], 1.06), liver dysfunction in 21 trials (OR, 1.33), renal insufficiency in eight trials (OR, 1.14), and cataracts or other eye-related conditions in six trials (OR, 1.23).

At the same time, statins decreased risks for myocardial infarction in 22 trials (OR, 0.72), stroke in 17 trials (OR, 0.80), and CVD death in 22 trials (OR, 0.83).

These risks translated into 15 more events of muscle symptoms, 8 more liver events, 12 more kidney events, and 14 more eye conditions per 10,000 patients treated for a year.

Statins were estimated to prevent 19 myocardial infarctions, 9 strokes, and 8 CVD deaths per 10,000 patients treated for a year.

Dr. Sheppard suggested that the inclusion of previously omitted trials and the decision to classify muscle problems as self-reported symptoms or clinically defined muscle disorders based on changes in creatine kinase might explain why they found the association with statins, whereas most systematic reviews have not.

“Some people would argue that these side effects are so small and so negligible that we shouldn’t talk about them, but the problem with doing that is if you’ve got a patient who has a preconceived idea that statins are harmful,” he added. “So having some empirical data where you can actually say: ‘Look, just 15 people out of 10,000 patients who’ve been treated for a year might experience one of those self-reported muscle symptoms,’ hopefully, will be helpful for physicians having discussions in practice.”

The analysis is “another data point indicating the overall safety and net benefit of statins for patients, even in primary prevention,” Donald M. Lloyd-Jones, MD, ScM, chair of preventive medicine, Northwestern University, Chicago, said in an interview.

He noted that the renal insufficiency findings are difficult to interpret, given that the endpoint was defined as “any decline in renal function,” but that most will have been clinically unimportant. In general, most studies didn’t systematically look to ascertain some of adverse events but relied on participant or physician report. “Nonetheless, there is little reason to suspect bias in the collection of these data among the blinded studies.

“Although not definitive, given the study design and inclusion of very different types of studies and variable ascertainment of adverse events, the findings are reassuring that the risks of adverse events were small, and the potential adverse events identified were not very clinically significant and clearly outweighed by the important beneficial reductions in major cardiovascular events,” said Dr. Lloyd-Jones.

“This study is yet another reminder of the safety of statins,” Ann Marie Navar, MD, PhD, a specialist in preventive cardiology at UT Southwestern Medical School, Dallas, said in an email.

“I’m pleased to have a comprehensive study like this – a well-done, systematic review of randomized trials – to help combat the vast amounts of misinformation about statins circulating on the Internet.”

Dr. Lloyd-Jones also acknowledged the need to address misinformation, pointing out that the loss of contact with physicians and the adverse effects of the pandemic on weight and other health behaviors mean that many patients have had worsening of their cardiovascular risk factors.

“We must continue to help patients and the public understand that statins are beneficial for patients at sufficient risk for cardiovascular disease because of elevated cholesterol or their total burden of risk factors,” Dr. Lloyd-Jones said. “We must also be upfront about the risks of potential side effects, which are uncommon and almost always very easily managed with washout and dose reduction or switching to a different drug in the same class.”

Analyses by type of statin, however, showed few significant differences in adverse events. Rosuvastatin was associated with increased risks for self-reported muscle symptoms, renal insufficiency, diabetes, and eye conditions, whereas atorvastatin and lovastatin increased the risk for liver dysfunction.

In dose-response meta-analyses, a possible modest dose-response relationship was detected only for the effect of atorvastatin on liver dysfunction.

The current data do not support tailoring the type of statin or dosage to reduce adverse events, the authors say, although routine monitoring of liver function during treatment is probably warranted in primary prevention, given the increased risk for liver dysfunction.

To help improve adherence to statins, the investigators said, additional studies are needed to identify patient characteristics crucial to the small risks of adverse events.

Limitations of the research, they said, are that many of the analyses were underpowered to detect between-group differences, many trials had short periods of follow-up, and some trials excluded vulnerable people more likely to have adverse events, such as those with high serum creatinine.

The study was funded by a British Heart Foundation PhD Scholarship held by first author Ting Cai. Dr. Sheppard reports receiving funding from a Wellcome Trust/Royal Society Sir Henry Dale Fellowship. Disclosures for other authors are listed in the paper. Dr. Lloyd-Jones and Dr. Navar report having no conflicts of interest.

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

Statins are associated with a low risk of adverse events in patients without a history of heart disease, but the potential harms are small and should not deter their use in primary prevention, a new systematic review and meta-analysis concludes.

RogerAshford/Thinkstock

As reported July 14 in BMJ, the analysis showed a slightly increased risk for self-reported muscle symptoms after treatment with statins but no increased risk for clinically confirmed muscle disorders. Statins were associated with liver dysfunction, renal insufficiency, and eye conditions, but not with diabetes.

“These risks are very, very small and, in fact, the adverse events we’re talking about are potentially quite mild, so if you weigh them against the benefits in terms of reduction in major cardiovascular events, the benefit-to-harm ratio is very much in favor of prescribing treatment for almost all patients,” senior author James P. Sheppard, MD, University of Oxford (England), said in an interview.

Although there’s an abundance of data showing that statins prevent recurrent cardiovascular events, their use is controversial in primary prevention, owing partly to the lower risk for cardiovascular disease (CVD). The absolute benefits of statins are smaller in primary prevention than in those with existing CVD, and the benefit-to-harm balance of treatment might be less favorable, the authors note.

A 2019 review suggested that the use of statins in primary prevention may be an example of “low-value care, having little benefit and potential to cause harm,” and a meta-analysis with more than 94,000 trial participants showed statins significantly increased risks for myopathy, renal dysfunction, and hepatic dysfunction.

Nevertheless, clinical guidelines have recommended wider use of statins for primary prevention, calling on physicians to weigh the benefits and harms.

“This is a reasonable expectation but, at present, the data on the harms of treatment are much less well understood in comparison to the benefits and there’s quite a lot of debate about the extent to which statins are associated with adverse events,” Dr. Sheppard said. “So we wanted to look at this in a bit more detail.”

The investigators analyzed results from 62 randomized controlled trials with 120,456 participants (mean age, 61; 40% women) followed for a mean of 3.9 years. All but two studies enrolled participants with hyperlipidemia or dyslipidemia. Common comorbidities were diabetes (11 studies), asymptomatic atherosclerosis (nine studies), and hypertension (four studies).

Statins increased risks for self-reported muscle symptoms in 21 trials (odds ratio [OR], 1.06), liver dysfunction in 21 trials (OR, 1.33), renal insufficiency in eight trials (OR, 1.14), and cataracts or other eye-related conditions in six trials (OR, 1.23).

At the same time, statins decreased risks for myocardial infarction in 22 trials (OR, 0.72), stroke in 17 trials (OR, 0.80), and CVD death in 22 trials (OR, 0.83).

These risks translated into 15 more events of muscle symptoms, 8 more liver events, 12 more kidney events, and 14 more eye conditions per 10,000 patients treated for a year.

Statins were estimated to prevent 19 myocardial infarctions, 9 strokes, and 8 CVD deaths per 10,000 patients treated for a year.

Dr. Sheppard suggested that the inclusion of previously omitted trials and the decision to classify muscle problems as self-reported symptoms or clinically defined muscle disorders based on changes in creatine kinase might explain why they found the association with statins, whereas most systematic reviews have not.

“Some people would argue that these side effects are so small and so negligible that we shouldn’t talk about them, but the problem with doing that is if you’ve got a patient who has a preconceived idea that statins are harmful,” he added. “So having some empirical data where you can actually say: ‘Look, just 15 people out of 10,000 patients who’ve been treated for a year might experience one of those self-reported muscle symptoms,’ hopefully, will be helpful for physicians having discussions in practice.”

The analysis is “another data point indicating the overall safety and net benefit of statins for patients, even in primary prevention,” Donald M. Lloyd-Jones, MD, ScM, chair of preventive medicine, Northwestern University, Chicago, said in an interview.

He noted that the renal insufficiency findings are difficult to interpret, given that the endpoint was defined as “any decline in renal function,” but that most will have been clinically unimportant. In general, most studies didn’t systematically look to ascertain some of adverse events but relied on participant or physician report. “Nonetheless, there is little reason to suspect bias in the collection of these data among the blinded studies.

“Although not definitive, given the study design and inclusion of very different types of studies and variable ascertainment of adverse events, the findings are reassuring that the risks of adverse events were small, and the potential adverse events identified were not very clinically significant and clearly outweighed by the important beneficial reductions in major cardiovascular events,” said Dr. Lloyd-Jones.

“This study is yet another reminder of the safety of statins,” Ann Marie Navar, MD, PhD, a specialist in preventive cardiology at UT Southwestern Medical School, Dallas, said in an email.

“I’m pleased to have a comprehensive study like this – a well-done, systematic review of randomized trials – to help combat the vast amounts of misinformation about statins circulating on the Internet.”

Dr. Lloyd-Jones also acknowledged the need to address misinformation, pointing out that the loss of contact with physicians and the adverse effects of the pandemic on weight and other health behaviors mean that many patients have had worsening of their cardiovascular risk factors.

“We must continue to help patients and the public understand that statins are beneficial for patients at sufficient risk for cardiovascular disease because of elevated cholesterol or their total burden of risk factors,” Dr. Lloyd-Jones said. “We must also be upfront about the risks of potential side effects, which are uncommon and almost always very easily managed with washout and dose reduction or switching to a different drug in the same class.”

Analyses by type of statin, however, showed few significant differences in adverse events. Rosuvastatin was associated with increased risks for self-reported muscle symptoms, renal insufficiency, diabetes, and eye conditions, whereas atorvastatin and lovastatin increased the risk for liver dysfunction.

In dose-response meta-analyses, a possible modest dose-response relationship was detected only for the effect of atorvastatin on liver dysfunction.

The current data do not support tailoring the type of statin or dosage to reduce adverse events, the authors say, although routine monitoring of liver function during treatment is probably warranted in primary prevention, given the increased risk for liver dysfunction.

To help improve adherence to statins, the investigators said, additional studies are needed to identify patient characteristics crucial to the small risks of adverse events.

Limitations of the research, they said, are that many of the analyses were underpowered to detect between-group differences, many trials had short periods of follow-up, and some trials excluded vulnerable people more likely to have adverse events, such as those with high serum creatinine.

The study was funded by a British Heart Foundation PhD Scholarship held by first author Ting Cai. Dr. Sheppard reports receiving funding from a Wellcome Trust/Royal Society Sir Henry Dale Fellowship. Disclosures for other authors are listed in the paper. Dr. Lloyd-Jones and Dr. Navar report having no conflicts of interest.

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

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.

In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.

The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.

Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.

Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.

“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.

By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.

All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.

“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.

The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.

The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.

“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
 

Cautious optimism, long-term monitoring

The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.

“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.

The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.

“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.

The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.

Practicing rheumatologists in the United States received more than $220 million from pharmaceutical companies during 2014-2019, with payments increasing each year, according to findings from a descriptive study of the Centers for Medicare & Medicaid Services Open Payments Database.

Rheumatologists have identified conflicts of interest as an ethical concern, but the details of industry payments to rheumatologists have not been investigated, wrote Michael Putman, MD, of the Medical College of Wisconsin, Milwaukee, and colleagues in Arthritis & Rheumatology. “Payments among rheumatologists may be of particular interest,” given their frequent prescription of expensive and primarily on-patent biologic and targeted disease-modifying antirheumatic drugs (DMARDs), the researchers said.

Over the 2014-2019 study period, 5,723 rheumatologists received a total of $221,254,966 from 1,610,668 payments. Of these, 3,416 (59%) received less than $5,000; 368 (6%) received more than $100,000, accounting for 78% of the total payments. The yearly value of the payments increased from $29,755,133 in 2014 to $46,308,926 in 2019, a 56% increase.

The payments to individual rheumatologists during the study period ranged from $8 to $5,612,254, with a median individual payment of $2,818. However, most (81%) of the payments were less than $25, and only 4% were more than $1,000.

Physicians who received more than $100,000 were significantly more likely to be paid speakers’ fees, consulting fees, and travel and lodging fees, but significantly less likely to receive payments for food and beverage than were those who received less than $100,000.

Overall, women made up 43% of the study population and received 34% of the total payments.

However, the median payment to male rheumatologists was significantly higher than the median payment to female rheumatologists ($3,732 vs. $2,084). Female rheumatologists were significantly more likely to receive payments for food and beverage and significantly less likely to receive speakers’ fees or travel and lodging coverage.

When the data were analyzed by state, California had the highest amount of total payments ($27,769,124), followed by New York and Texas, while Arizona had the highest spending per rheumatologist ($143,559). By region, based on U.S. Census divisions, the highest spending occurred in the Middle Atlantic Division ($46,327,351) and the highest per rheumatologist spending occurred in the East-South Central Division ($49,605).

“These data suggest industry payments in rheumatology have followed two distinct patterns, which have been observed in other medical subspecialties,” specifically, that many small payments are made to a large number of physicians, and large-value payments are made to a small number of physicians, the researchers noted.

The impact of small payments cannot be discounted, they said, “as even small gifts may affect behavior and are associated with prescribing patterns.” The impact of large payments on behavior and practice deserve further investigation, “but it is notable that a recent evaluation of rheumatology clinical practice guidelines identified substantial involvement from rheumatologists who had accepted large values of industry payments,” the researchers added.

Approximately half the total value of payments came from three companies: Bristol-Myers Squibb (20%), Abbvie (17%), and Pfizer (12%). Medications associated with the highest spending included Otezla, Humira, and Xeljanz.

Of note, the data showed that H.P. Acthar gel was among the top 10 agents for total payments, and “over 90% of rheumatologists who frequently prescribe H.P. Acthar gel have also received H.P. Acthar–related payments, raising the possibility that such payments have influenced prescribing behavior,” given the lack of high-quality evidence to support its use and the availability of less expensive alternatives, the researchers said.

The study findings were limited by several factors, including the focus only on general payments to rheumatologists, and the lack of external sources to verify payments, the researchers noted. “Most importantly, this was a descriptive study, and the degree to which payments have influenced physician behavior lies outside the scope of this work. Future studies should investigate the degree to which industry payments have influenced prescribing in the field of rheumatology.”

Focus on collaborations that add value

The study is important because previous data on the magnitude of payments or payment patterns from pharmaceutical companies to practicing rheumatologists were limited, lead author Dr. Putman said in an interview.

“I was most surprised by some of the medications that received high values of payments,” he said. “Many payments were linked to medications that we use commonly and that have high-quality data supporting their use. That was not surprising, and you could imagine dollars spent on [interleukin]-23 or IL-17 inhibitors being used in a way that is valuable to other physicians or to patients with rheumatic diseases. On the other hand, some medications – most notably H.P. Acthar gel – have no high-quality data supporting their use, are used by a very small cadre of physicians, and are extraordinarily expensive. At least in my opinion, there is no world where payments linked to H.P. Acthar gel provide any benefit for physicians or patients.”

Dr. Putman said he expected that the patterns and the increases observed in the study are likely to continue.

“Ultimately, I have a somewhat nuanced view of financial conflicts of interest,” he said. “Collaborations between the pharmaceutical industry and rheumatologists have provided extraordinary value to our field. I think rheumatologists should be much more involved in some areas. At the same time, I think we should be much less involved in marketing drugs that provide little value to patients and great cost to society. H.P. Acthar Gel is the classic example of this, but there are others as well. I think future research should focus on how these payments influence behavior and should seek to identify areas where they result in low-value care.” Going forward, valuable collaborations between rheumatologists and the pharmaceutical industry should be encouraged, but collaborations without value should be discouraged, he said.
 

Industry payments serve no useful purpose

The findings “highlight the overarching concern regarding the ability of industry payments to adversely affect care quality within the specific context of rheumatology practice,” Aaron P. Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York, wrote in an accompanying editorial.

Dr. Mitchell emphasized several points, starting with the temporal trend showing an increase in industry payments beyond the rate of inflation that has not been universal across specialties. He also emphasized the “highly skewed distribution of payments,” with a large majority going to a relatively small number of rheumatologists. “This suggests an industry strategy of targeting ‘key opinion leaders,’ or KOLs, with higher payments,” and which was not surprising, as similar patterns have been seen in other specialties. Dr. Mitchell noted that 10 drugs accounted for more than half of the payments, and that “the unifying feature of these drugs is their high cost.”

“The picture of industry strategy that emerges from Putman et al. and other similar reports is that of intense, sustained KOL-focused marketing soon after the release of a new high-margin drug,” he wrote.

Despite the descriptive nature of the study, the findings have clinical implications based on other studies of the consequences of industry payments with respect to care quality, Dr. Mitchell said. “Hypothetically, industry spending to promote drugs to physicians could increase dissemination of new, superior drugs, improving patient outcomes.” However, physicians tend to opt for game-changing drugs without added incentive; “it is the less-innovative drugs that industry has to push harder.”

The practice of industry payments for physicians becomes even more difficult to rationalize given the potential for increased out-of-pocket costs and potentially avoidable toxicities for patients, Dr. Mitchell said. “Moreover, industry payments serve no unmet need; through our professional societies and other nonprofit sources, we physicians are fully capable of staying up-to-date on new treatments without relying on industry meals and sponsored events.”
 

Disclosure of payments is important

The study is important because it is essential to understand how public disclosure of industry payments influences financial relationship between the biomedical industry and physicians, said Amarnath Annapureddy, MD, a clinical fellow in cardiology at Yale University, New Haven, Conn., who has studied and written about industry payments to physicians.

Dr. Annapureddy said in an interview that he was surprised by how the study findings were opposite to the assumption that public disclosure would dissuade continuation of financial ties between physicians and industry. “This study showed payments increased over time rather than decreasing due to public disclosure.”

However, Dr. Annapureddy said that he was not surprised at how few physicians received the bulk of industry payments. “These physicians are considered to be ‘key opinion leaders’ who could influence practicing patterns of other physicians. These findings are similar to payment patterns for other specialties, including cardiology.

“So far, no study has evaluated factors that drive changes in industry payment patterns,” Dr. Annapureddy said. “I anticipate the patterns noted in this study will continue at least in the short term. If health care systems mandate physicians to disclose potential conflicts of interest to the patients, it may reduce payments.”

However, “unless, there is a major health policy mandate by government, I anticipate public disclosure of payments through the open payments program will not impact industry-physician ties,” he said. “This study has not evaluated impact of payments on prescribing practices. There are overwhelming data from several studies that showed payments influence physicians practicing patterns, whether it is prescribing a medication or implanting a device.” However, as for additional research, Dr. Annapureddy said that it would interesting to see a randomized trial to show whether the way physicians disclose their financial ties with patients would impact their practicing patterns.

The study received no outside funding. Dr. Putman was supported by a Rheumatology Research grant, but he and the other researchers had no financial conflicts to disclose. Dr. Mitchell disclosed a merit award from the nonprofit Conquer Cancer Foundation, for which the Foundation received financial support from Merck. Dr. Annapureddy had no financial conflicts to disclose.

Practicing rheumatologists in the United States received more than $220 million from pharmaceutical companies during 2014-2019, with payments increasing each year, according to findings from a descriptive study of the Centers for Medicare & Medicaid Services Open Payments Database.

Rheumatologists have identified conflicts of interest as an ethical concern, but the details of industry payments to rheumatologists have not been investigated, wrote Michael Putman, MD, of the Medical College of Wisconsin, Milwaukee, and colleagues in Arthritis & Rheumatology. “Payments among rheumatologists may be of particular interest,” given their frequent prescription of expensive and primarily on-patent biologic and targeted disease-modifying antirheumatic drugs (DMARDs), the researchers said.

Over the 2014-2019 study period, 5,723 rheumatologists received a total of $221,254,966 from 1,610,668 payments. Of these, 3,416 (59%) received less than $5,000; 368 (6%) received more than $100,000, accounting for 78% of the total payments. The yearly value of the payments increased from $29,755,133 in 2014 to $46,308,926 in 2019, a 56% increase.

The payments to individual rheumatologists during the study period ranged from $8 to $5,612,254, with a median individual payment of $2,818. However, most (81%) of the payments were less than $25, and only 4% were more than $1,000.

Physicians who received more than $100,000 were significantly more likely to be paid speakers’ fees, consulting fees, and travel and lodging fees, but significantly less likely to receive payments for food and beverage than were those who received less than $100,000.

Overall, women made up 43% of the study population and received 34% of the total payments.

However, the median payment to male rheumatologists was significantly higher than the median payment to female rheumatologists ($3,732 vs. $2,084). Female rheumatologists were significantly more likely to receive payments for food and beverage and significantly less likely to receive speakers’ fees or travel and lodging coverage.

When the data were analyzed by state, California had the highest amount of total payments ($27,769,124), followed by New York and Texas, while Arizona had the highest spending per rheumatologist ($143,559). By region, based on U.S. Census divisions, the highest spending occurred in the Middle Atlantic Division ($46,327,351) and the highest per rheumatologist spending occurred in the East-South Central Division ($49,605).

“These data suggest industry payments in rheumatology have followed two distinct patterns, which have been observed in other medical subspecialties,” specifically, that many small payments are made to a large number of physicians, and large-value payments are made to a small number of physicians, the researchers noted.

The impact of small payments cannot be discounted, they said, “as even small gifts may affect behavior and are associated with prescribing patterns.” The impact of large payments on behavior and practice deserve further investigation, “but it is notable that a recent evaluation of rheumatology clinical practice guidelines identified substantial involvement from rheumatologists who had accepted large values of industry payments,” the researchers added.

Approximately half the total value of payments came from three companies: Bristol-Myers Squibb (20%), Abbvie (17%), and Pfizer (12%). Medications associated with the highest spending included Otezla, Humira, and Xeljanz.

Of note, the data showed that H.P. Acthar gel was among the top 10 agents for total payments, and “over 90% of rheumatologists who frequently prescribe H.P. Acthar gel have also received H.P. Acthar–related payments, raising the possibility that such payments have influenced prescribing behavior,” given the lack of high-quality evidence to support its use and the availability of less expensive alternatives, the researchers said.

The study findings were limited by several factors, including the focus only on general payments to rheumatologists, and the lack of external sources to verify payments, the researchers noted. “Most importantly, this was a descriptive study, and the degree to which payments have influenced physician behavior lies outside the scope of this work. Future studies should investigate the degree to which industry payments have influenced prescribing in the field of rheumatology.”

Focus on collaborations that add value

The study is important because previous data on the magnitude of payments or payment patterns from pharmaceutical companies to practicing rheumatologists were limited, lead author Dr. Putman said in an interview.

“I was most surprised by some of the medications that received high values of payments,” he said. “Many payments were linked to medications that we use commonly and that have high-quality data supporting their use. That was not surprising, and you could imagine dollars spent on [interleukin]-23 or IL-17 inhibitors being used in a way that is valuable to other physicians or to patients with rheumatic diseases. On the other hand, some medications – most notably H.P. Acthar gel – have no high-quality data supporting their use, are used by a very small cadre of physicians, and are extraordinarily expensive. At least in my opinion, there is no world where payments linked to H.P. Acthar gel provide any benefit for physicians or patients.”

Dr. Putman said he expected that the patterns and the increases observed in the study are likely to continue.

“Ultimately, I have a somewhat nuanced view of financial conflicts of interest,” he said. “Collaborations between the pharmaceutical industry and rheumatologists have provided extraordinary value to our field. I think rheumatologists should be much more involved in some areas. At the same time, I think we should be much less involved in marketing drugs that provide little value to patients and great cost to society. H.P. Acthar Gel is the classic example of this, but there are others as well. I think future research should focus on how these payments influence behavior and should seek to identify areas where they result in low-value care.” Going forward, valuable collaborations between rheumatologists and the pharmaceutical industry should be encouraged, but collaborations without value should be discouraged, he said.
 

Industry payments serve no useful purpose

The findings “highlight the overarching concern regarding the ability of industry payments to adversely affect care quality within the specific context of rheumatology practice,” Aaron P. Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York, wrote in an accompanying editorial.

Dr. Mitchell emphasized several points, starting with the temporal trend showing an increase in industry payments beyond the rate of inflation that has not been universal across specialties. He also emphasized the “highly skewed distribution of payments,” with a large majority going to a relatively small number of rheumatologists. “This suggests an industry strategy of targeting ‘key opinion leaders,’ or KOLs, with higher payments,” and which was not surprising, as similar patterns have been seen in other specialties. Dr. Mitchell noted that 10 drugs accounted for more than half of the payments, and that “the unifying feature of these drugs is their high cost.”

“The picture of industry strategy that emerges from Putman et al. and other similar reports is that of intense, sustained KOL-focused marketing soon after the release of a new high-margin drug,” he wrote.

Despite the descriptive nature of the study, the findings have clinical implications based on other studies of the consequences of industry payments with respect to care quality, Dr. Mitchell said. “Hypothetically, industry spending to promote drugs to physicians could increase dissemination of new, superior drugs, improving patient outcomes.” However, physicians tend to opt for game-changing drugs without added incentive; “it is the less-innovative drugs that industry has to push harder.”

The practice of industry payments for physicians becomes even more difficult to rationalize given the potential for increased out-of-pocket costs and potentially avoidable toxicities for patients, Dr. Mitchell said. “Moreover, industry payments serve no unmet need; through our professional societies and other nonprofit sources, we physicians are fully capable of staying up-to-date on new treatments without relying on industry meals and sponsored events.”
 

Disclosure of payments is important

The study is important because it is essential to understand how public disclosure of industry payments influences financial relationship between the biomedical industry and physicians, said Amarnath Annapureddy, MD, a clinical fellow in cardiology at Yale University, New Haven, Conn., who has studied and written about industry payments to physicians.

Dr. Annapureddy said in an interview that he was surprised by how the study findings were opposite to the assumption that public disclosure would dissuade continuation of financial ties between physicians and industry. “This study showed payments increased over time rather than decreasing due to public disclosure.”

However, Dr. Annapureddy said that he was not surprised at how few physicians received the bulk of industry payments. “These physicians are considered to be ‘key opinion leaders’ who could influence practicing patterns of other physicians. These findings are similar to payment patterns for other specialties, including cardiology.

“So far, no study has evaluated factors that drive changes in industry payment patterns,” Dr. Annapureddy said. “I anticipate the patterns noted in this study will continue at least in the short term. If health care systems mandate physicians to disclose potential conflicts of interest to the patients, it may reduce payments.”

However, “unless, there is a major health policy mandate by government, I anticipate public disclosure of payments through the open payments program will not impact industry-physician ties,” he said. “This study has not evaluated impact of payments on prescribing practices. There are overwhelming data from several studies that showed payments influence physicians practicing patterns, whether it is prescribing a medication or implanting a device.” However, as for additional research, Dr. Annapureddy said that it would interesting to see a randomized trial to show whether the way physicians disclose their financial ties with patients would impact their practicing patterns.

The study received no outside funding. Dr. Putman was supported by a Rheumatology Research grant, but he and the other researchers had no financial conflicts to disclose. Dr. Mitchell disclosed a merit award from the nonprofit Conquer Cancer Foundation, for which the Foundation received financial support from Merck. Dr. Annapureddy had no financial conflicts to disclose.

Practicing rheumatologists in the United States received more than $220 million from pharmaceutical companies during 2014-2019, with payments increasing each year, according to findings from a descriptive study of the Centers for Medicare & Medicaid Services Open Payments Database.

Rheumatologists have identified conflicts of interest as an ethical concern, but the details of industry payments to rheumatologists have not been investigated, wrote Michael Putman, MD, of the Medical College of Wisconsin, Milwaukee, and colleagues in Arthritis & Rheumatology. “Payments among rheumatologists may be of particular interest,” given their frequent prescription of expensive and primarily on-patent biologic and targeted disease-modifying antirheumatic drugs (DMARDs), the researchers said.

Over the 2014-2019 study period, 5,723 rheumatologists received a total of $221,254,966 from 1,610,668 payments. Of these, 3,416 (59%) received less than $5,000; 368 (6%) received more than $100,000, accounting for 78% of the total payments. The yearly value of the payments increased from $29,755,133 in 2014 to $46,308,926 in 2019, a 56% increase.

The payments to individual rheumatologists during the study period ranged from $8 to $5,612,254, with a median individual payment of $2,818. However, most (81%) of the payments were less than $25, and only 4% were more than $1,000.

Physicians who received more than $100,000 were significantly more likely to be paid speakers’ fees, consulting fees, and travel and lodging fees, but significantly less likely to receive payments for food and beverage than were those who received less than $100,000.

Overall, women made up 43% of the study population and received 34% of the total payments.

However, the median payment to male rheumatologists was significantly higher than the median payment to female rheumatologists ($3,732 vs. $2,084). Female rheumatologists were significantly more likely to receive payments for food and beverage and significantly less likely to receive speakers’ fees or travel and lodging coverage.

When the data were analyzed by state, California had the highest amount of total payments ($27,769,124), followed by New York and Texas, while Arizona had the highest spending per rheumatologist ($143,559). By region, based on U.S. Census divisions, the highest spending occurred in the Middle Atlantic Division ($46,327,351) and the highest per rheumatologist spending occurred in the East-South Central Division ($49,605).

“These data suggest industry payments in rheumatology have followed two distinct patterns, which have been observed in other medical subspecialties,” specifically, that many small payments are made to a large number of physicians, and large-value payments are made to a small number of physicians, the researchers noted.

The impact of small payments cannot be discounted, they said, “as even small gifts may affect behavior and are associated with prescribing patterns.” The impact of large payments on behavior and practice deserve further investigation, “but it is notable that a recent evaluation of rheumatology clinical practice guidelines identified substantial involvement from rheumatologists who had accepted large values of industry payments,” the researchers added.

Approximately half the total value of payments came from three companies: Bristol-Myers Squibb (20%), Abbvie (17%), and Pfizer (12%). Medications associated with the highest spending included Otezla, Humira, and Xeljanz.

Of note, the data showed that H.P. Acthar gel was among the top 10 agents for total payments, and “over 90% of rheumatologists who frequently prescribe H.P. Acthar gel have also received H.P. Acthar–related payments, raising the possibility that such payments have influenced prescribing behavior,” given the lack of high-quality evidence to support its use and the availability of less expensive alternatives, the researchers said.

The study findings were limited by several factors, including the focus only on general payments to rheumatologists, and the lack of external sources to verify payments, the researchers noted. “Most importantly, this was a descriptive study, and the degree to which payments have influenced physician behavior lies outside the scope of this work. Future studies should investigate the degree to which industry payments have influenced prescribing in the field of rheumatology.”

Focus on collaborations that add value

The study is important because previous data on the magnitude of payments or payment patterns from pharmaceutical companies to practicing rheumatologists were limited, lead author Dr. Putman said in an interview.

“I was most surprised by some of the medications that received high values of payments,” he said. “Many payments were linked to medications that we use commonly and that have high-quality data supporting their use. That was not surprising, and you could imagine dollars spent on [interleukin]-23 or IL-17 inhibitors being used in a way that is valuable to other physicians or to patients with rheumatic diseases. On the other hand, some medications – most notably H.P. Acthar gel – have no high-quality data supporting their use, are used by a very small cadre of physicians, and are extraordinarily expensive. At least in my opinion, there is no world where payments linked to H.P. Acthar gel provide any benefit for physicians or patients.”

Dr. Putman said he expected that the patterns and the increases observed in the study are likely to continue.

“Ultimately, I have a somewhat nuanced view of financial conflicts of interest,” he said. “Collaborations between the pharmaceutical industry and rheumatologists have provided extraordinary value to our field. I think rheumatologists should be much more involved in some areas. At the same time, I think we should be much less involved in marketing drugs that provide little value to patients and great cost to society. H.P. Acthar Gel is the classic example of this, but there are others as well. I think future research should focus on how these payments influence behavior and should seek to identify areas where they result in low-value care.” Going forward, valuable collaborations between rheumatologists and the pharmaceutical industry should be encouraged, but collaborations without value should be discouraged, he said.
 

Industry payments serve no useful purpose

The findings “highlight the overarching concern regarding the ability of industry payments to adversely affect care quality within the specific context of rheumatology practice,” Aaron P. Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York, wrote in an accompanying editorial.

Dr. Mitchell emphasized several points, starting with the temporal trend showing an increase in industry payments beyond the rate of inflation that has not been universal across specialties. He also emphasized the “highly skewed distribution of payments,” with a large majority going to a relatively small number of rheumatologists. “This suggests an industry strategy of targeting ‘key opinion leaders,’ or KOLs, with higher payments,” and which was not surprising, as similar patterns have been seen in other specialties. Dr. Mitchell noted that 10 drugs accounted for more than half of the payments, and that “the unifying feature of these drugs is their high cost.”

“The picture of industry strategy that emerges from Putman et al. and other similar reports is that of intense, sustained KOL-focused marketing soon after the release of a new high-margin drug,” he wrote.

Despite the descriptive nature of the study, the findings have clinical implications based on other studies of the consequences of industry payments with respect to care quality, Dr. Mitchell said. “Hypothetically, industry spending to promote drugs to physicians could increase dissemination of new, superior drugs, improving patient outcomes.” However, physicians tend to opt for game-changing drugs without added incentive; “it is the less-innovative drugs that industry has to push harder.”

The practice of industry payments for physicians becomes even more difficult to rationalize given the potential for increased out-of-pocket costs and potentially avoidable toxicities for patients, Dr. Mitchell said. “Moreover, industry payments serve no unmet need; through our professional societies and other nonprofit sources, we physicians are fully capable of staying up-to-date on new treatments without relying on industry meals and sponsored events.”
 

Disclosure of payments is important

The study is important because it is essential to understand how public disclosure of industry payments influences financial relationship between the biomedical industry and physicians, said Amarnath Annapureddy, MD, a clinical fellow in cardiology at Yale University, New Haven, Conn., who has studied and written about industry payments to physicians.

Dr. Annapureddy said in an interview that he was surprised by how the study findings were opposite to the assumption that public disclosure would dissuade continuation of financial ties between physicians and industry. “This study showed payments increased over time rather than decreasing due to public disclosure.”

However, Dr. Annapureddy said that he was not surprised at how few physicians received the bulk of industry payments. “These physicians are considered to be ‘key opinion leaders’ who could influence practicing patterns of other physicians. These findings are similar to payment patterns for other specialties, including cardiology.

“So far, no study has evaluated factors that drive changes in industry payment patterns,” Dr. Annapureddy said. “I anticipate the patterns noted in this study will continue at least in the short term. If health care systems mandate physicians to disclose potential conflicts of interest to the patients, it may reduce payments.”

However, “unless, there is a major health policy mandate by government, I anticipate public disclosure of payments through the open payments program will not impact industry-physician ties,” he said. “This study has not evaluated impact of payments on prescribing practices. There are overwhelming data from several studies that showed payments influence physicians practicing patterns, whether it is prescribing a medication or implanting a device.” However, as for additional research, Dr. Annapureddy said that it would interesting to see a randomized trial to show whether the way physicians disclose their financial ties with patients would impact their practicing patterns.

The study received no outside funding. Dr. Putman was supported by a Rheumatology Research grant, but he and the other researchers had no financial conflicts to disclose. Dr. Mitchell disclosed a merit award from the nonprofit Conquer Cancer Foundation, for which the Foundation received financial support from Merck. Dr. Annapureddy had no financial conflicts to disclose.

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

In what could be a model for other states, Texas has become the first state to exempt physicians from prior authorizations for meeting insurer benchmarks.

The law was passed in June and will take effect in September. It excuses physicians from having to obtain prior authorization if, during the previous 6 months, 90% of their treatments met medical necessity criteria by the health insurer. Through this law, doctors in the state will spend less time getting approvals for treatments for their patients.

Automatic approval of authorizations for treatments – or what the Texas Medical Association (TMA) calls a “gold card” – “allows patients to get the care they need in a more timely fashion,” says Debra Patt, MD, an Austin, Tex.–based oncologist and former chair of the council on legislation for the TMA.

Eighty-seven percent of Texas physicians reported a “drastic increase over the past five years in the burden of prior authorization on their patients and their practices,” per a 2020 survey by the TMA. Nearly half (48%) of Texas physicians have hired staff whose work focuses on processing requests for prior authorization, according to the survey.

Jack Resneck Jr., MD, a San Francisco–based dermatologist and president-elect of the American Medical Association (AMA), said other states have investigated ways to ease the impact of prior authorizations on physicians, but no other state has passed such a law.

Administrative burdens plague physicians around the country. The Medscape Physician Compensation Report 2021 found that physicians spend on average 15.6 hours per week on paperwork and administrative duties.
 

Better outcomes, less anxiety for patients

Dr. Patt, who testified in support of the law’s passage in the Texas legislature, says automatic approval of authorizations “is better for patients because it reduces their anxiety about whether they’re able to get the treatments they need now, and they will have better outcomes if they’re able to receive more timely care.”

Recently, a chemotherapy treatment Dr. Patt prescribed for one of her patients was not authorized by an insurer. The result is “a lot of anxiety and potentially health problems” for the patient, said Dr. Patt.

She expects that automatic approval for treatments will be based on prescribing patterns during the preceding 6 months. “It means that when I order a test today, the [health insurer] looks back at my record 6 months previously,” she said. Still, Dr. Patt awaits guidance from the Texas Department of Insurance, which regulates health insurers in the state, regarding the law.

Dr. Resneck said the pharmacy counter is where most patients encounter prior authorization delays. “That’s when the pharmacist looks at them and says, ‘Actually, this isn’t covered by your health insurer’s formulary,’ or it isn’t covered fully on their formulary.”

One of Dr. Resneck’s patients had a life-altering case of eczema that lasted many years. Because of the condition, the patient couldn’t work or maintain meaningful bonds with family members. A biologic treatment transformed his patient’s life. The patient was able to return to work and to re-engage with family, said Dr. Resneck. But a year after his patient started the treatment, the health insurer wouldn’t authorize the treatment because the patient wasn’t experiencing the same symptoms.

The patient didn’t have the same symptoms because the biologic treatment worked, said Dr. Resneck.

Kristine Grow, a spokesperson for America’s Health Insurance Plans, a national association for health insurers, said, “The use of prior authorization is relatively small – typically, less than 15% – and can help ensure safer opioid prescribing, help prevent dangerous drug interactions, and help protect patients from unnecessary exposure to potentially harmful radiation for inappropriate diagnostic imaging. Numerous studies show that Americans frequently receive inappropriate care, and 25% of unnecessary treatments are associated with complications or adverse events.”

Medical management tools, such as prior authorization, are an “an important way” to deliver “safe, high-quality care” to patients, she added.
 

State and federal efforts to curb prior authorization

In addition to efforts to curb prior authorization in other states, the AMA supports the Improving Seniors’ Timely Access to Care Act (HR 3173). The act includes a provision related to “gold-carding,” said Robert Mills, an AMA spokesperson.

The bill establishes requirements and standards for prior authorization processes related to Medicare Advantage (MA) plans. The requirements and standards for MA plans include the following:

• Establishing an electronic prior authorization program that meets specific standards, such as the ability to provide real-time decisions in response to requests for items and services that are routinely approved.
• Publishing on an annual basis specific prior authorization information, including the percentage of requests approved and the average response time.
• Meeting standards set by the Centers for Medicare & Medicaid Services related to the quality and timeliness of prior authorization determinations.

The act was introduced to the U.S. House of Representatives in May, after which it was referred to two committees for consideration.

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

U.S. Sen. Chuck Schumer, the Senate majority leader, is cosponsoring legislation that would decriminalize marijuana at the federal level.

VladK213/Getty Images

The Cannabis Administration & Opportunity Act would allow the federal government to regulate and tax marijuana sales for the first time and would stop the federal prosecution of people for possessing and selling the drug, The New York Times reported. States could still make their own marijuana laws, however.

The bill calls for using money raised by taxing marijuana to help poor people and communities of color that have been unduly affected by marijuana laws.

Arrests and convictions for nonviolent marijuana offenses would be automatically expunged, The New York Times reported.

“The War on Drugs has been a war on people – particularly people of color,” a draft of the bill said, adding that the bill “aims to end the decades of harm inflicted on communities of color by removing cannabis from the federal list of controlled substances and empowering states to implement their own cannabis laws.”

But passage of the bill is highly uncertain because of strong Republican opposition in the Senate, where Democrats hold a narrow majority, according to The New York Times.

President Biden has not said he supports such legislation.

Sen. Schumer signaled his intentions when he spoke on April 20, the unofficial holiday for marijuana smokers.

“Hopefully, the next time this unofficial holiday of 4/20 rolls around, our country will have made progress in addressing the massive overcriminalization of marijuana in a meaningful and comprehensive way,” he said at the time, the newspaper reported.

Cosponsors were U.S. Sen. Cory Booker of New Jersey and U.S. Sen. Ron Wyden of Oregon, chairman of the Senate Finance Committee.

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

U.S. Sen. Chuck Schumer, the Senate majority leader, is cosponsoring legislation that would decriminalize marijuana at the federal level.

VladK213/Getty Images

The Cannabis Administration & Opportunity Act would allow the federal government to regulate and tax marijuana sales for the first time and would stop the federal prosecution of people for possessing and selling the drug, The New York Times reported. States could still make their own marijuana laws, however.

The bill calls for using money raised by taxing marijuana to help poor people and communities of color that have been unduly affected by marijuana laws.

Arrests and convictions for nonviolent marijuana offenses would be automatically expunged, The New York Times reported.

“The War on Drugs has been a war on people – particularly people of color,” a draft of the bill said, adding that the bill “aims to end the decades of harm inflicted on communities of color by removing cannabis from the federal list of controlled substances and empowering states to implement their own cannabis laws.”

But passage of the bill is highly uncertain because of strong Republican opposition in the Senate, where Democrats hold a narrow majority, according to The New York Times.

President Biden has not said he supports such legislation.

Sen. Schumer signaled his intentions when he spoke on April 20, the unofficial holiday for marijuana smokers.

“Hopefully, the next time this unofficial holiday of 4/20 rolls around, our country will have made progress in addressing the massive overcriminalization of marijuana in a meaningful and comprehensive way,” he said at the time, the newspaper reported.

Cosponsors were U.S. Sen. Cory Booker of New Jersey and U.S. Sen. Ron Wyden of Oregon, chairman of the Senate Finance Committee.

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

U.S. Sen. Chuck Schumer, the Senate majority leader, is cosponsoring legislation that would decriminalize marijuana at the federal level.

VladK213/Getty Images

The Cannabis Administration & Opportunity Act would allow the federal government to regulate and tax marijuana sales for the first time and would stop the federal prosecution of people for possessing and selling the drug, The New York Times reported. States could still make their own marijuana laws, however.

The bill calls for using money raised by taxing marijuana to help poor people and communities of color that have been unduly affected by marijuana laws.

Arrests and convictions for nonviolent marijuana offenses would be automatically expunged, The New York Times reported.

“The War on Drugs has been a war on people – particularly people of color,” a draft of the bill said, adding that the bill “aims to end the decades of harm inflicted on communities of color by removing cannabis from the federal list of controlled substances and empowering states to implement their own cannabis laws.”

But passage of the bill is highly uncertain because of strong Republican opposition in the Senate, where Democrats hold a narrow majority, according to The New York Times.

President Biden has not said he supports such legislation.

Sen. Schumer signaled his intentions when he spoke on April 20, the unofficial holiday for marijuana smokers.

“Hopefully, the next time this unofficial holiday of 4/20 rolls around, our country will have made progress in addressing the massive overcriminalization of marijuana in a meaningful and comprehensive way,” he said at the time, the newspaper reported.

Cosponsors were U.S. Sen. Cory Booker of New Jersey and U.S. Sen. Ron Wyden of Oregon, chairman of the Senate Finance Committee.

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

Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.

Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).

Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).

Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.

“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.

“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.

The study was published online July 12 in BMJ Open.
 

Personal experience

The study was “inspired by experiences that I endured over a period of time and am grateful to have survived,” said Dr. Van Spall.

“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.

Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”

To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.

Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.

Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.

“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
 

Systemic sexism

Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.

The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).

“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.

“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.

“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.

She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
 

Multiple deterrents

Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).

Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.

When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.

The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).

Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
 

Support available

Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”

Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.

“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”

She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.

“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.

Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.

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

Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.

Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).

Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).

Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.

“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.

“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.

The study was published online July 12 in BMJ Open.
 

Personal experience

The study was “inspired by experiences that I endured over a period of time and am grateful to have survived,” said Dr. Van Spall.

“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.

Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”

To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.

Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.

Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.

“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
 

Systemic sexism

Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.

The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).

“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.

“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.

“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.

She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
 

Multiple deterrents

Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).

Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.

When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.

The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).

Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
 

Support available

Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”

Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.

“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”

She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.

“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.

Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.

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

Bullying in academic medicine, especially among women, is rife, underreported, and remains largely unaddressed, new research suggests.

Investigators reviewed close to 70 studies, encompassing over 82,000 medical consultants or trainees in academic medical settings, and found that men were identified as the most common perpetrators – close to 70% of respondents – whereas women were the most common victims (56%).

Collectively, respondents in all of the studies identified the most common bullies to be consultants (54%), followed by residents (22%), and nurses (15%).

Disturbingly, less than one-third of victims overall reported that they were bullied, and close to 60% who formally reported the abuse said they did not have a positive outcome.

“We found that bullies are commonly men and senior consultants, while more than half of their victims are women,” senior author Harriette G.C. Van Spall, MD, MPH, associate professor of medicine and director of e-health and virtual care, Division of Cardiology, McMaster University, Hamilton, Ont., said in an interview.

“The greatest barriers to addressing academic bullying are the fear of reprisal, lack of impact of reporting, and non-enforcement of anti-bullying policies,” she added.

The study was published online July 12 in BMJ Open.
 

Personal experience

The study was “inspired by experiences that I endured over a period of time and am grateful to have survived,” said Dr. Van Spall.

“Some behaviors were excruciating to deal with, protesting against them would bring more on, and every day was filled with dread. It took sheer will to show up at work to care for patients, to complete research I was leading, and to have hope, and my academic output, income, and personal well-being dropped during those years,” she added.

Dr. Van Spall thought the subject “merited research because our performance as clinicians, researchers, and educators relies on our work environment.”

To investigate, the researchers reviewed 68 studies (n = 82,349 respondents) conducted between 1999 and 2021 in academic medical settings, in which victims were either consultants or trainees. Many of the studies (31) were conducted in the U.S.

Other countries included the United Kingdom, Canada, Australia, Pakistan, Egypt, Iran, Turkey, New Zealand, Lithuania, Greece, India, Germany, Nigeria, Oman, and Finland.

Studies were required to describe the method and impact of bullying; characteristics of the perpetrators and victims; or interventions that were used to address the bullying.

“Bullying” was defined as “the abuse of authority by a perpetrator who targets the victim in an academic setting through punishing behaviors that include overwork, destabilization, and isolation in order to impede the education or career of the target.”
 

Systemic sexism

Bullying behaviors, reported in 28 studies (n = 35,779 respondents), were grouped into destabilization, threats to professional status, overwork, and isolation, with overwork found to be the most common form of bullying.

The most common impact of being bullied was psychological distress, reported by 39.1% of respondents in 14 studies, followed by considerations of quitting (35.9%; 7 studies), and worsening of clinical performance (34.6%, 8 studies).

“Among demographic groups, men were identified as the most common perpetrators (67.2% of 4,722 respondents in 5 studies) and women the most common victims (56.2% of 15,246 respondents in 27 studies),” the authors report.

“Academic medicine in many institutions is encumbered by systemic sexism that is evident in processes around remuneration, recognition, opportunities for advancement, and leadership positions,” said Dr. Van Spall.

“There are fewer women at decision-making tables in academic medicine, the climb is uphill at the best of times, and women are likely easier targets for bullies, as their voices are easier to drown out,” she added.

She noted that many men do “exhibit wonderful attributes of professionalism and decency,” but “some in positions of power are given impunity by virtue of other accomplishments.”
 

Multiple deterrents

Thirty-one studies (n = 15,868) described characteristics of the bullies and showed the most common to be consultants (53.6% [30 studies]), residents (22% [22 studies]), and nurses (14.9% [21 studies]).

Only a minority of victims (28.9% of 9,410 victims [10 studies]) formally reported the bullying. The researchers identified multiple deterrents to reporting.

When a formal complaint was submitted (n = 1,139 respondents), it most frequently had no perceived effect (35.6%); more than one-fifth (21.9%) experienced worsening of the bullying, and only 13.7% reported improvement.

The common institutional facilitators of bullying, described in 25 studies, included lack of enforcement of anti-bullying policies (13 studies), the hierarchical structure of medicine (7 studies), and normalization of bullying (10 studies).

Forty-nine studies looked at strategies to address academic bullying, including anti-bullying policies, mandatory workshops on mistreatment, establishing an anti-bullying oversight committee, and institutional support for victims. However, the studies testing the effectiveness of these interventions “had a high risk of bias.”
 

Support available

Commenting on the research for this news organization, Roberta Gebhard, DO, past president of the American Medical Women’s Association (AMWA) and a member of the advisory board for Physician Just Equity, called it a “good study, large, international, and well-written.”

Dr. Gebhard, a member of the Governing Council for the American Medical Association Women Physician Section, was not associated with this study but said she is currently researching women who left medical school and residency.

“A common reason for leaving is being bullied. Bullying is often not reported and if reported, often not addressed. Or, if addressed, the person who reports it is often retaliated against, which is a common experience, especially in women.”

She advised female physicians who are bullied to get support from other female physicians – for example, by joining the AMWA, which has an online women’s leadership group.

“Having other women physicians throughout the country you can call for advice and support can be helpful,” said Dr. Gebhard, a family practice physician based in Grand Island, New York.

Dr. Van Spall receives support from the Canadian Institutes of Health Research, the Heart and Stroke Foundation, the Women As One Escalator Award, and McMaster Department of Medicine. The study authors and Dr. Gebhard have disclosed no relevant financial relationships.

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

An extreme price to pay for immortality

We know that men don’t live as long as women, but the reasons aren’t entirely clear. However, some New Zealand scientists have a thought on the subject, thanks to a sheep called Shrek.

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The researchers were inspired by a famous old sheep who escaped captivity, but was captured 6 years later at the age of 10. The sheep then lived 6 more years, far beyond the lifespan of a normal sheep, capturing the hearts and minds of Kiwis everywhere. Look, it’s New Zealand, sheep are life, so it’s only natural the country got attached. Scientists from the University of Otago suspected that Shrek lived such a long life because he was castrated.

So they undertook a study of sheep, and lo and behold, sheep that were castrated lived significantly longer than their uncastrated kin, thanks to a slowing of their epigenetic clocks – the DNA aged noticeably slower in the castrated sheep.

Although the research can most immediately be applied to the improvement of the New Zealand sheep industry, the implication for humanity is also apparent. Want to live longer? Get rid of the testosterone. An extreme solution to be sure. As previously reported in this column, researchers wanted to torture our mouths to get us to lose weight, and now they want to castrate people for longer life. What exactly is going on down there in New Zealand?

Man’s best mind reader

There are a lot of reasons why dogs are sometimes called “man’s best friend,” but the root of it may actually have something to do with how easily we communicate with each other. Researchers dug deeper and fetched something that Fido is born with, but his wild wolf cousin isn’t.

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That something is known as the “theory of mind” ability. Have you noticed that when you point and tell dogs to grab a leash or toy, they react as if they understood the language you spoke? Researchers from Duke University wondered if this ability is a canine thing or just a domesticated dog thing.

They compared 44 canine puppies and 37 wolf pups between 5 and 18 weeks old. The wolf pups were taken into human homes and raised with a great amount of human interaction, while the dog pups were left with their mothers and raised with less human interaction.

All the puppies were then put through multiple tests. In one test, they were given clues to find a treat under a bowl. In another test, a block of wood was placed next to the treat as a physical marker. During yet another test, researchers pointed to the food directly.

The researchers discovered that the dog puppies knew where the treat was every time, while their wild relatives didn’t.

“This study really solidifies the evidence that the social genius of dogs is a product of domestication,” senior author Brian Hare said in a separate statement.

The domestication hypothesis theorizes that dogs picked up the human social cues through thousands of years of interaction. The more friendly and cooperative a wolf was with humans, the more likely it was to survive and pass on those same traits and practices. Even within the study, the dog puppies were 30 times more likely to approach a stranger than were the wolf pups.

You may think your dog understands everything you say, but it’s actually body language that Fido is most fluent in.