User login
Bringing you the latest news, research and reviews, exclusive interviews, podcasts, quizzes, and more.
div[contains(@class, 'header__large-screen')]
div[contains(@class, 'read-next-article')]
div[contains(@class, 'main-prefix')]
div[contains(@class, 'nav-primary')]
nav[contains(@class, 'nav-primary')]
section[contains(@class, 'footer-nav-section-wrapper')]
footer[@id='footer']
section[contains(@class, 'nav-hidden')]
div[contains(@class, 'ce-card-content')]
nav[contains(@class, 'nav-ce-stack')]
div[contains(@class, 'view-medstat-quiz-listing-panes')]
div[contains(@class, 'pane-article-sidebar-latest-news')]
div[contains(@class, 'medstat-accordion-set article-series')]
ERISA Health Plan Lawsuits: Why Should We Care?
A recently filed lawsuit against Johnson & Johnson can serve as an example to use when advocating for patients who have insurance through their employers that can potentially hurt them physically and financially. When your patient has an employer-funded health insurance plan where the employer directly pays for all medical costs — called an ERISA plan for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act — there are certain accountability, fairness, and fiduciary responsibilities that the employers must meet. These so-called ERISA plans do not have to follow state utilization management legislation that addresses harmful changes in insurers’ formularies and other policies, so when the plans are not properly overseen and do not mandate the delivery of proper care at the lowest cost, both the patient and employer may be losing out.
The J&J lawsuit serves as a bellwether warning to self-insured employers to demand transparency from their third-party administrators so as not to (knowingly or unknowingly) breach their fiduciary duty to their health plans and employees. These duties include ensuring reasonable plan costs as well as acting in the best interest of their employees. There were multiple complaints in the lawsuit by a J&J employee, stating that she paid a much higher price for her multiple sclerosis drug through the plan than the price she eventually found at a lower cost pharmacy. The allegations state that J&J failed to show prudence in its selection of a pharmacy benefit manager (PBM). In addition, the company failed to negotiate better drug pricing terms, and the design of the drug plan steered patients to the PBM specialty pharmacy, resulting in higher prices for the employees. All of these led to higher drug costs and premiums for employees, which, according to the lawsuit, is a breach of J&J’s fiduciary duties.
Why Should Rheumatologists Care About This?
With all insurance plans, it feels as though we are dealing with obstacles every day that keep us from giving the excellent rheumatologic care that our patients deserve. Self-insured employers now account for over 50% of commercial health plans, and as rheumatologists caring for the employees of these companies, we can use those transparency, accountability, and fiduciary responsibilities of the employer to ensure that our patients are getting the proper care at the lowest cost.
Not only is the J&J lawsuit a warning to self-insured employers, but a reminder to rheumatologists to be on the lookout for drug pricing issues and formulary construction that leads to higher pricing for employees and the plan. For example, make note if your patient is forced to fail a much higher priced self-injectable biologic before using a much lower cost infusible medication. Or if the plan mandates the use of the much higher priced adalimumab biosimilars over the lower priced biosimilars or even the highest priced JAK inhibitor over the lowest priced one. Let’s not forget mandated white bagging, which is often much more expensive to the plan than the buy-and-bill model through a rheumatologist’s office.
Recently, we have been able to help rheumatology practices get exemptions from white-bagging mandates that large self-insured employers often have in their plan documents. We have been able to show that the cost of obtaining the medication through specialty pharmacy (SP) is much higher than through the buy-and-bill model. Mandating that the plan spend more money on SP drugs, as opposed to allowing the rheumatologist to buy and bill, could easily be interpreted as a breach of fiduciary duty on the part of the employer by mandating a higher cost model.
CSRO Payer Issue Response Team
I have written about the Coalition of State Rheumatology Organizations (CSRO)’s Payer Issue Response Team (PIRT) in the past. Rheumatologists around the country can send to PIRT any problems that they are having with payers. A recent PIRT submission involved a white-bagging mandate for an employee of a very large international Fortune 500 company. This particular example is important because of the response by the VP of Global Benefits for this company. Express Scripts is the administrator of pharmacy benefits for this company. The rheumatologist was told that he could not buy and bill for an infusible medicine but would have to obtain the drug through Express Scripts’ SP. He then asked Express Scripts for the SP medication’s cost to the health plan in order to compare the SP price versus what the buy-and-bill model would cost this company. Express Scripts would not respond to this simple transparency question; often, PBMs claim that this is proprietary information.
I was able to speak with the company’s VP of Global Benefits regarding this issue. First of all, he stated that his company was not mandating white bagging. I explained to him that the plan documents had white bagging as the only option for acquisition of provider-administered drugs. A rheumatologist would have to apply for an exemption to buy and bill, and in this case, it was denied. This is essentially a mandate.
I gave the VP of Global Benefits an example of another large Fortune 500 company (UPS) that spent over $30,000 per year more on an infusible medication when obtained through SP than what it cost them under a buy-and-bill model. I had hoped that this example would impress upon the VP the importance of transparency in pricing and claims to prevent his company from unknowingly costing the health plan more and its being construed as a breach of fiduciary duty. It was explained to me by the VP of Global Benefits that his company is part of the National Drug Purchasers Coalition and they trust Express Scripts to do the right thing for them. As they say, “You can lead a horse to water, but can’t make it drink.”
Liability of a Plan That Physically Harms an Employee?
A slightly different example of a self-insured employer, presumably unknowingly, allowing its third-party administrator to mishandle the care of an employee was recently brought to me by a rheumatologist in North Carolina. She takes care of an employee who has rheumatoid arthritis with severe interstitial lung disease (ILD). The employee’s pulmonary status was stabilized on several courses of Rituxan (reference product of rituximab). Recently, BlueCross BlueShield of North Carolina, the third-party administrator of this employer’s plan, mandated a switch to a biosimilar of rituximab for the treatment of the ILD. The rheumatologist appealed the nonmedical switch but gave the patient the biosimilar so as not to delay care. Her patient’s condition is now deteriorating with progression of the ILD, and she once again has asked for an exemption to use Rituxan, which had initially stabilized the patient. Her staff told her that the BCBSNC rep said that the patient would have to have a life-threatening infusion reaction (and present the bill for the ambulance) before they would approve a return to the reference product. An employer that knowingly or unknowingly allows a third-party administrator to act in such a way as to endanger the life of an employee could be considered to be breaching its fiduciary duty. (Disclaimer: I am not an attorney — merely a rheumatologist with common sense. Nor am I making any qualitative statement about biosimilars.)
We now have a lawsuit to which you can refer when advocating for our patients who are employed by large, self-insured employers. It is unfortunate that it is not the third-party administrators or PBMs that can be sued, as they are generally not the fiduciaries for the plan. It is the unsuspecting employers who “trust” their brokers/consultants and the third-party administrators to do the right thing. Please continue to send us your payer issues. And if your patient works for a self-insured employer, I will continue to remind the CEO, CFO, and chief compliance officer that an employer with an ERISA health plan can potentially face legal action if the health plan’s actions or decisions cause harm to an employee’s health — physically or in the wallet.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past 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 [email protected].
A recently filed lawsuit against Johnson & Johnson can serve as an example to use when advocating for patients who have insurance through their employers that can potentially hurt them physically and financially. When your patient has an employer-funded health insurance plan where the employer directly pays for all medical costs — called an ERISA plan for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act — there are certain accountability, fairness, and fiduciary responsibilities that the employers must meet. These so-called ERISA plans do not have to follow state utilization management legislation that addresses harmful changes in insurers’ formularies and other policies, so when the plans are not properly overseen and do not mandate the delivery of proper care at the lowest cost, both the patient and employer may be losing out.
The J&J lawsuit serves as a bellwether warning to self-insured employers to demand transparency from their third-party administrators so as not to (knowingly or unknowingly) breach their fiduciary duty to their health plans and employees. These duties include ensuring reasonable plan costs as well as acting in the best interest of their employees. There were multiple complaints in the lawsuit by a J&J employee, stating that she paid a much higher price for her multiple sclerosis drug through the plan than the price she eventually found at a lower cost pharmacy. The allegations state that J&J failed to show prudence in its selection of a pharmacy benefit manager (PBM). In addition, the company failed to negotiate better drug pricing terms, and the design of the drug plan steered patients to the PBM specialty pharmacy, resulting in higher prices for the employees. All of these led to higher drug costs and premiums for employees, which, according to the lawsuit, is a breach of J&J’s fiduciary duties.
Why Should Rheumatologists Care About This?
With all insurance plans, it feels as though we are dealing with obstacles every day that keep us from giving the excellent rheumatologic care that our patients deserve. Self-insured employers now account for over 50% of commercial health plans, and as rheumatologists caring for the employees of these companies, we can use those transparency, accountability, and fiduciary responsibilities of the employer to ensure that our patients are getting the proper care at the lowest cost.
Not only is the J&J lawsuit a warning to self-insured employers, but a reminder to rheumatologists to be on the lookout for drug pricing issues and formulary construction that leads to higher pricing for employees and the plan. For example, make note if your patient is forced to fail a much higher priced self-injectable biologic before using a much lower cost infusible medication. Or if the plan mandates the use of the much higher priced adalimumab biosimilars over the lower priced biosimilars or even the highest priced JAK inhibitor over the lowest priced one. Let’s not forget mandated white bagging, which is often much more expensive to the plan than the buy-and-bill model through a rheumatologist’s office.
Recently, we have been able to help rheumatology practices get exemptions from white-bagging mandates that large self-insured employers often have in their plan documents. We have been able to show that the cost of obtaining the medication through specialty pharmacy (SP) is much higher than through the buy-and-bill model. Mandating that the plan spend more money on SP drugs, as opposed to allowing the rheumatologist to buy and bill, could easily be interpreted as a breach of fiduciary duty on the part of the employer by mandating a higher cost model.
CSRO Payer Issue Response Team
I have written about the Coalition of State Rheumatology Organizations (CSRO)’s Payer Issue Response Team (PIRT) in the past. Rheumatologists around the country can send to PIRT any problems that they are having with payers. A recent PIRT submission involved a white-bagging mandate for an employee of a very large international Fortune 500 company. This particular example is important because of the response by the VP of Global Benefits for this company. Express Scripts is the administrator of pharmacy benefits for this company. The rheumatologist was told that he could not buy and bill for an infusible medicine but would have to obtain the drug through Express Scripts’ SP. He then asked Express Scripts for the SP medication’s cost to the health plan in order to compare the SP price versus what the buy-and-bill model would cost this company. Express Scripts would not respond to this simple transparency question; often, PBMs claim that this is proprietary information.
I was able to speak with the company’s VP of Global Benefits regarding this issue. First of all, he stated that his company was not mandating white bagging. I explained to him that the plan documents had white bagging as the only option for acquisition of provider-administered drugs. A rheumatologist would have to apply for an exemption to buy and bill, and in this case, it was denied. This is essentially a mandate.
I gave the VP of Global Benefits an example of another large Fortune 500 company (UPS) that spent over $30,000 per year more on an infusible medication when obtained through SP than what it cost them under a buy-and-bill model. I had hoped that this example would impress upon the VP the importance of transparency in pricing and claims to prevent his company from unknowingly costing the health plan more and its being construed as a breach of fiduciary duty. It was explained to me by the VP of Global Benefits that his company is part of the National Drug Purchasers Coalition and they trust Express Scripts to do the right thing for them. As they say, “You can lead a horse to water, but can’t make it drink.”
Liability of a Plan That Physically Harms an Employee?
A slightly different example of a self-insured employer, presumably unknowingly, allowing its third-party administrator to mishandle the care of an employee was recently brought to me by a rheumatologist in North Carolina. She takes care of an employee who has rheumatoid arthritis with severe interstitial lung disease (ILD). The employee’s pulmonary status was stabilized on several courses of Rituxan (reference product of rituximab). Recently, BlueCross BlueShield of North Carolina, the third-party administrator of this employer’s plan, mandated a switch to a biosimilar of rituximab for the treatment of the ILD. The rheumatologist appealed the nonmedical switch but gave the patient the biosimilar so as not to delay care. Her patient’s condition is now deteriorating with progression of the ILD, and she once again has asked for an exemption to use Rituxan, which had initially stabilized the patient. Her staff told her that the BCBSNC rep said that the patient would have to have a life-threatening infusion reaction (and present the bill for the ambulance) before they would approve a return to the reference product. An employer that knowingly or unknowingly allows a third-party administrator to act in such a way as to endanger the life of an employee could be considered to be breaching its fiduciary duty. (Disclaimer: I am not an attorney — merely a rheumatologist with common sense. Nor am I making any qualitative statement about biosimilars.)
We now have a lawsuit to which you can refer when advocating for our patients who are employed by large, self-insured employers. It is unfortunate that it is not the third-party administrators or PBMs that can be sued, as they are generally not the fiduciaries for the plan. It is the unsuspecting employers who “trust” their brokers/consultants and the third-party administrators to do the right thing. Please continue to send us your payer issues. And if your patient works for a self-insured employer, I will continue to remind the CEO, CFO, and chief compliance officer that an employer with an ERISA health plan can potentially face legal action if the health plan’s actions or decisions cause harm to an employee’s health — physically or in the wallet.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past 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 [email protected].
A recently filed lawsuit against Johnson & Johnson can serve as an example to use when advocating for patients who have insurance through their employers that can potentially hurt them physically and financially. When your patient has an employer-funded health insurance plan where the employer directly pays for all medical costs — called an ERISA plan for the federal law that governs employee benefit plans, the Employee Retirement Income Security Act — there are certain accountability, fairness, and fiduciary responsibilities that the employers must meet. These so-called ERISA plans do not have to follow state utilization management legislation that addresses harmful changes in insurers’ formularies and other policies, so when the plans are not properly overseen and do not mandate the delivery of proper care at the lowest cost, both the patient and employer may be losing out.
The J&J lawsuit serves as a bellwether warning to self-insured employers to demand transparency from their third-party administrators so as not to (knowingly or unknowingly) breach their fiduciary duty to their health plans and employees. These duties include ensuring reasonable plan costs as well as acting in the best interest of their employees. There were multiple complaints in the lawsuit by a J&J employee, stating that she paid a much higher price for her multiple sclerosis drug through the plan than the price she eventually found at a lower cost pharmacy. The allegations state that J&J failed to show prudence in its selection of a pharmacy benefit manager (PBM). In addition, the company failed to negotiate better drug pricing terms, and the design of the drug plan steered patients to the PBM specialty pharmacy, resulting in higher prices for the employees. All of these led to higher drug costs and premiums for employees, which, according to the lawsuit, is a breach of J&J’s fiduciary duties.
Why Should Rheumatologists Care About This?
With all insurance plans, it feels as though we are dealing with obstacles every day that keep us from giving the excellent rheumatologic care that our patients deserve. Self-insured employers now account for over 50% of commercial health plans, and as rheumatologists caring for the employees of these companies, we can use those transparency, accountability, and fiduciary responsibilities of the employer to ensure that our patients are getting the proper care at the lowest cost.
Not only is the J&J lawsuit a warning to self-insured employers, but a reminder to rheumatologists to be on the lookout for drug pricing issues and formulary construction that leads to higher pricing for employees and the plan. For example, make note if your patient is forced to fail a much higher priced self-injectable biologic before using a much lower cost infusible medication. Or if the plan mandates the use of the much higher priced adalimumab biosimilars over the lower priced biosimilars or even the highest priced JAK inhibitor over the lowest priced one. Let’s not forget mandated white bagging, which is often much more expensive to the plan than the buy-and-bill model through a rheumatologist’s office.
Recently, we have been able to help rheumatology practices get exemptions from white-bagging mandates that large self-insured employers often have in their plan documents. We have been able to show that the cost of obtaining the medication through specialty pharmacy (SP) is much higher than through the buy-and-bill model. Mandating that the plan spend more money on SP drugs, as opposed to allowing the rheumatologist to buy and bill, could easily be interpreted as a breach of fiduciary duty on the part of the employer by mandating a higher cost model.
CSRO Payer Issue Response Team
I have written about the Coalition of State Rheumatology Organizations (CSRO)’s Payer Issue Response Team (PIRT) in the past. Rheumatologists around the country can send to PIRT any problems that they are having with payers. A recent PIRT submission involved a white-bagging mandate for an employee of a very large international Fortune 500 company. This particular example is important because of the response by the VP of Global Benefits for this company. Express Scripts is the administrator of pharmacy benefits for this company. The rheumatologist was told that he could not buy and bill for an infusible medicine but would have to obtain the drug through Express Scripts’ SP. He then asked Express Scripts for the SP medication’s cost to the health plan in order to compare the SP price versus what the buy-and-bill model would cost this company. Express Scripts would not respond to this simple transparency question; often, PBMs claim that this is proprietary information.
I was able to speak with the company’s VP of Global Benefits regarding this issue. First of all, he stated that his company was not mandating white bagging. I explained to him that the plan documents had white bagging as the only option for acquisition of provider-administered drugs. A rheumatologist would have to apply for an exemption to buy and bill, and in this case, it was denied. This is essentially a mandate.
I gave the VP of Global Benefits an example of another large Fortune 500 company (UPS) that spent over $30,000 per year more on an infusible medication when obtained through SP than what it cost them under a buy-and-bill model. I had hoped that this example would impress upon the VP the importance of transparency in pricing and claims to prevent his company from unknowingly costing the health plan more and its being construed as a breach of fiduciary duty. It was explained to me by the VP of Global Benefits that his company is part of the National Drug Purchasers Coalition and they trust Express Scripts to do the right thing for them. As they say, “You can lead a horse to water, but can’t make it drink.”
Liability of a Plan That Physically Harms an Employee?
A slightly different example of a self-insured employer, presumably unknowingly, allowing its third-party administrator to mishandle the care of an employee was recently brought to me by a rheumatologist in North Carolina. She takes care of an employee who has rheumatoid arthritis with severe interstitial lung disease (ILD). The employee’s pulmonary status was stabilized on several courses of Rituxan (reference product of rituximab). Recently, BlueCross BlueShield of North Carolina, the third-party administrator of this employer’s plan, mandated a switch to a biosimilar of rituximab for the treatment of the ILD. The rheumatologist appealed the nonmedical switch but gave the patient the biosimilar so as not to delay care. Her patient’s condition is now deteriorating with progression of the ILD, and she once again has asked for an exemption to use Rituxan, which had initially stabilized the patient. Her staff told her that the BCBSNC rep said that the patient would have to have a life-threatening infusion reaction (and present the bill for the ambulance) before they would approve a return to the reference product. An employer that knowingly or unknowingly allows a third-party administrator to act in such a way as to endanger the life of an employee could be considered to be breaching its fiduciary duty. (Disclaimer: I am not an attorney — merely a rheumatologist with common sense. Nor am I making any qualitative statement about biosimilars.)
We now have a lawsuit to which you can refer when advocating for our patients who are employed by large, self-insured employers. It is unfortunate that it is not the third-party administrators or PBMs that can be sued, as they are generally not the fiduciaries for the plan. It is the unsuspecting employers who “trust” their brokers/consultants and the third-party administrators to do the right thing. Please continue to send us your payer issues. And if your patient works for a self-insured employer, I will continue to remind the CEO, CFO, and chief compliance officer that an employer with an ERISA health plan can potentially face legal action if the health plan’s actions or decisions cause harm to an employee’s health — physically or in the wallet.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s Vice President of Advocacy and Government Affairs and its immediate Past President, as well as past 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 [email protected].
Medicare Doc Pay Cut Eased, but When Will Serious Revisions Come?
President Joe Biden on March 9 signed into law a measure that softened — but did not completely eliminate — a 2024 cut in a key rate used to determine how physicians are paid for treating Medicare patients.
While physician groups hailed the move as partial relief, they say they’ll continue to press for broader changes in the Medicare physician fee schedule.
The Medicare provision was tucked into a larger spending package approved by the US House and Senate.
The American Academy of Family Physicians (AAFP), the American Medical Association (AMA), and other groups have lobbied Congress for months to undo a 3.4% cut in the base rate, or conversion factor, in the physician fee schedule for 2024.
The conversion factor is used in calculations to determine reimbursement for myriad other services. Federal Medicare officials said the cut would mean a 1.25% decrease in overall payments in 2024, compared with 2023.
“With the passage of this legislation, Congress has offset 2.93% of that payment cut,” said Steven P. Furr, MD, AAFP’s president in a statement. “We appreciate this temporary measure but continue to urge Congress to advance comprehensive, long-term Medicare payment reform.”
In a statement, Representative Larry Bucshon, MD (R-IN), said the payment cut could not be completely eliminated because of budget constraints.
The Medicare physician fee schedule covers much of the care clinicians provide to people older than 65 and those with disabilities. It covers about 8000 different types of services, ranging from office visits to surgical procedures, imaging, and tests, according to the Medicare Payment Advisory Commission (MedPAC).
Along with physicians, the fee schedule sets payments for nurse practitioners, physician assistants, podiatrists, physical therapists, psychologists, and other clinicians.
In 2021, the Medicare program and its beneficiaries paid $92.8 billion for services provided by almost 1.3 million clinicians, MedPAC said.
Larger Changes Ahead?
Rep. Bucshon is among the physicians serving in the House who are pressing for a permanent revamp of the Medicare physician fee schedule. He cosponsored a bill (HR 2474) that would peg future annual increases in the physician fee schedule to the Medicare Economic Index, which would reflect inflation’s effect.
In April, more than 120 state and national medical groups signed onto an AMA-led letter urging Congress to pass this bill.
The measure is a key priority for the AMA. The organization reached out repeatedly last year to federal officials about it through its own in-house lobbyists, this news organization found through a review of congressional lobbying forms submitted by AMA.
These required disclosure forms reveal how much AMA and other organizations spend each quarter to appeal to members of Congress and federal agencies on specific issues. The disclosure forms do not include a detailed accounting of spending on each issue.
But they do show which issues are priorities for an organization. AMA’s in-house lobbyists reported raising dozens of issues in 2024 within contacts in Congress and federal agencies. These issues included abortion access, maternal health, physician burnout, and potential for bias in clinical use of algorithms, as well as Medicare payment for physicians.
AMA reported spending estimated cost of $20.6 million. (AMA spent $6.7 million in the first quarter, $4.75 million in the second quarter, $3.42 million in the third quarter, and $5.74 million in the fourth quarter.)
In a March 6 statement, Jesse M. Ehrenfeld, MD, MPH, AMA president, urged Congress to turn to more serious consideration of Medicare physician pay beyond short-term tweaks attached to other larger bills.
“As physicians, we are trained to run toward emergencies. We urge Congress to do the same,” Dr. Ehrenfeld said. “We encourage Congress to act if this policy decision is an emergency because — in fact — it is. It is well past time to put an end to stopgap measures that fail to address the underlying causes of the continuing decline in Medicare physician payments.”
There’s bipartisan interest in a revamp of the physician fee schedule amid widespread criticism of the last such overhaul, the Medicare Access and CHIP Reauthorization Act of 2015.
For example, Senate Budget Chairman Sheldon Whitehouse (D-RI) has proposed the creation of a technical advisory committee to improve how Medicare sets the physician fee schedule. The existing fee schedule provides too little money for primary care services and primary care provider pay, contributing to shortages, Sen. Whitehouse said.
Sen. Whitehouse on March 6 held a hearing on ways to beef up US primary care. Among the experts who appeared was Amol Navathe, MD, PhD, of the University of Pennsylvania, Philadelphia, Pennsylvania.
Dr. Navathe said the current Medicare physician fee schedule tilts in favor of procedural services, leading to “underinvestment in cognitive, diagnostic, and supportive services such as primary care.”
In addition, much of what primary care clinicians do, “such as addressing social challenges, is not included in the codes of the fee schedule itself,” said Dr. Navathe, who also serves as the vice chairman of MedPAC.
It’s unclear when Congress will attempt a serious revision to the Medicare physician fee schedule. Lawmakers are unlikely to take on such a major challenge in this election year.
There would be significant opposition and challenges for lawmakers in trying to clear a bill that added an inflation adjustment for what’s already seen as an imperfect physician fee schedule, said Mark E. Miller, PhD, executive vice president of healthcare at the philanthropy Arnold Ventures, which studies how payment decisions affect medical care.
“That bill could cost a lot of money and raise a lot of questions,” Dr. Miller said.
A version of this article appeared on Medscape.com.
President Joe Biden on March 9 signed into law a measure that softened — but did not completely eliminate — a 2024 cut in a key rate used to determine how physicians are paid for treating Medicare patients.
While physician groups hailed the move as partial relief, they say they’ll continue to press for broader changes in the Medicare physician fee schedule.
The Medicare provision was tucked into a larger spending package approved by the US House and Senate.
The American Academy of Family Physicians (AAFP), the American Medical Association (AMA), and other groups have lobbied Congress for months to undo a 3.4% cut in the base rate, or conversion factor, in the physician fee schedule for 2024.
The conversion factor is used in calculations to determine reimbursement for myriad other services. Federal Medicare officials said the cut would mean a 1.25% decrease in overall payments in 2024, compared with 2023.
“With the passage of this legislation, Congress has offset 2.93% of that payment cut,” said Steven P. Furr, MD, AAFP’s president in a statement. “We appreciate this temporary measure but continue to urge Congress to advance comprehensive, long-term Medicare payment reform.”
In a statement, Representative Larry Bucshon, MD (R-IN), said the payment cut could not be completely eliminated because of budget constraints.
The Medicare physician fee schedule covers much of the care clinicians provide to people older than 65 and those with disabilities. It covers about 8000 different types of services, ranging from office visits to surgical procedures, imaging, and tests, according to the Medicare Payment Advisory Commission (MedPAC).
Along with physicians, the fee schedule sets payments for nurse practitioners, physician assistants, podiatrists, physical therapists, psychologists, and other clinicians.
In 2021, the Medicare program and its beneficiaries paid $92.8 billion for services provided by almost 1.3 million clinicians, MedPAC said.
Larger Changes Ahead?
Rep. Bucshon is among the physicians serving in the House who are pressing for a permanent revamp of the Medicare physician fee schedule. He cosponsored a bill (HR 2474) that would peg future annual increases in the physician fee schedule to the Medicare Economic Index, which would reflect inflation’s effect.
In April, more than 120 state and national medical groups signed onto an AMA-led letter urging Congress to pass this bill.
The measure is a key priority for the AMA. The organization reached out repeatedly last year to federal officials about it through its own in-house lobbyists, this news organization found through a review of congressional lobbying forms submitted by AMA.
These required disclosure forms reveal how much AMA and other organizations spend each quarter to appeal to members of Congress and federal agencies on specific issues. The disclosure forms do not include a detailed accounting of spending on each issue.
But they do show which issues are priorities for an organization. AMA’s in-house lobbyists reported raising dozens of issues in 2024 within contacts in Congress and federal agencies. These issues included abortion access, maternal health, physician burnout, and potential for bias in clinical use of algorithms, as well as Medicare payment for physicians.
AMA reported spending estimated cost of $20.6 million. (AMA spent $6.7 million in the first quarter, $4.75 million in the second quarter, $3.42 million in the third quarter, and $5.74 million in the fourth quarter.)
In a March 6 statement, Jesse M. Ehrenfeld, MD, MPH, AMA president, urged Congress to turn to more serious consideration of Medicare physician pay beyond short-term tweaks attached to other larger bills.
“As physicians, we are trained to run toward emergencies. We urge Congress to do the same,” Dr. Ehrenfeld said. “We encourage Congress to act if this policy decision is an emergency because — in fact — it is. It is well past time to put an end to stopgap measures that fail to address the underlying causes of the continuing decline in Medicare physician payments.”
There’s bipartisan interest in a revamp of the physician fee schedule amid widespread criticism of the last such overhaul, the Medicare Access and CHIP Reauthorization Act of 2015.
For example, Senate Budget Chairman Sheldon Whitehouse (D-RI) has proposed the creation of a technical advisory committee to improve how Medicare sets the physician fee schedule. The existing fee schedule provides too little money for primary care services and primary care provider pay, contributing to shortages, Sen. Whitehouse said.
Sen. Whitehouse on March 6 held a hearing on ways to beef up US primary care. Among the experts who appeared was Amol Navathe, MD, PhD, of the University of Pennsylvania, Philadelphia, Pennsylvania.
Dr. Navathe said the current Medicare physician fee schedule tilts in favor of procedural services, leading to “underinvestment in cognitive, diagnostic, and supportive services such as primary care.”
In addition, much of what primary care clinicians do, “such as addressing social challenges, is not included in the codes of the fee schedule itself,” said Dr. Navathe, who also serves as the vice chairman of MedPAC.
It’s unclear when Congress will attempt a serious revision to the Medicare physician fee schedule. Lawmakers are unlikely to take on such a major challenge in this election year.
There would be significant opposition and challenges for lawmakers in trying to clear a bill that added an inflation adjustment for what’s already seen as an imperfect physician fee schedule, said Mark E. Miller, PhD, executive vice president of healthcare at the philanthropy Arnold Ventures, which studies how payment decisions affect medical care.
“That bill could cost a lot of money and raise a lot of questions,” Dr. Miller said.
A version of this article appeared on Medscape.com.
President Joe Biden on March 9 signed into law a measure that softened — but did not completely eliminate — a 2024 cut in a key rate used to determine how physicians are paid for treating Medicare patients.
While physician groups hailed the move as partial relief, they say they’ll continue to press for broader changes in the Medicare physician fee schedule.
The Medicare provision was tucked into a larger spending package approved by the US House and Senate.
The American Academy of Family Physicians (AAFP), the American Medical Association (AMA), and other groups have lobbied Congress for months to undo a 3.4% cut in the base rate, or conversion factor, in the physician fee schedule for 2024.
The conversion factor is used in calculations to determine reimbursement for myriad other services. Federal Medicare officials said the cut would mean a 1.25% decrease in overall payments in 2024, compared with 2023.
“With the passage of this legislation, Congress has offset 2.93% of that payment cut,” said Steven P. Furr, MD, AAFP’s president in a statement. “We appreciate this temporary measure but continue to urge Congress to advance comprehensive, long-term Medicare payment reform.”
In a statement, Representative Larry Bucshon, MD (R-IN), said the payment cut could not be completely eliminated because of budget constraints.
The Medicare physician fee schedule covers much of the care clinicians provide to people older than 65 and those with disabilities. It covers about 8000 different types of services, ranging from office visits to surgical procedures, imaging, and tests, according to the Medicare Payment Advisory Commission (MedPAC).
Along with physicians, the fee schedule sets payments for nurse practitioners, physician assistants, podiatrists, physical therapists, psychologists, and other clinicians.
In 2021, the Medicare program and its beneficiaries paid $92.8 billion for services provided by almost 1.3 million clinicians, MedPAC said.
Larger Changes Ahead?
Rep. Bucshon is among the physicians serving in the House who are pressing for a permanent revamp of the Medicare physician fee schedule. He cosponsored a bill (HR 2474) that would peg future annual increases in the physician fee schedule to the Medicare Economic Index, which would reflect inflation’s effect.
In April, more than 120 state and national medical groups signed onto an AMA-led letter urging Congress to pass this bill.
The measure is a key priority for the AMA. The organization reached out repeatedly last year to federal officials about it through its own in-house lobbyists, this news organization found through a review of congressional lobbying forms submitted by AMA.
These required disclosure forms reveal how much AMA and other organizations spend each quarter to appeal to members of Congress and federal agencies on specific issues. The disclosure forms do not include a detailed accounting of spending on each issue.
But they do show which issues are priorities for an organization. AMA’s in-house lobbyists reported raising dozens of issues in 2024 within contacts in Congress and federal agencies. These issues included abortion access, maternal health, physician burnout, and potential for bias in clinical use of algorithms, as well as Medicare payment for physicians.
AMA reported spending estimated cost of $20.6 million. (AMA spent $6.7 million in the first quarter, $4.75 million in the second quarter, $3.42 million in the third quarter, and $5.74 million in the fourth quarter.)
In a March 6 statement, Jesse M. Ehrenfeld, MD, MPH, AMA president, urged Congress to turn to more serious consideration of Medicare physician pay beyond short-term tweaks attached to other larger bills.
“As physicians, we are trained to run toward emergencies. We urge Congress to do the same,” Dr. Ehrenfeld said. “We encourage Congress to act if this policy decision is an emergency because — in fact — it is. It is well past time to put an end to stopgap measures that fail to address the underlying causes of the continuing decline in Medicare physician payments.”
There’s bipartisan interest in a revamp of the physician fee schedule amid widespread criticism of the last such overhaul, the Medicare Access and CHIP Reauthorization Act of 2015.
For example, Senate Budget Chairman Sheldon Whitehouse (D-RI) has proposed the creation of a technical advisory committee to improve how Medicare sets the physician fee schedule. The existing fee schedule provides too little money for primary care services and primary care provider pay, contributing to shortages, Sen. Whitehouse said.
Sen. Whitehouse on March 6 held a hearing on ways to beef up US primary care. Among the experts who appeared was Amol Navathe, MD, PhD, of the University of Pennsylvania, Philadelphia, Pennsylvania.
Dr. Navathe said the current Medicare physician fee schedule tilts in favor of procedural services, leading to “underinvestment in cognitive, diagnostic, and supportive services such as primary care.”
In addition, much of what primary care clinicians do, “such as addressing social challenges, is not included in the codes of the fee schedule itself,” said Dr. Navathe, who also serves as the vice chairman of MedPAC.
It’s unclear when Congress will attempt a serious revision to the Medicare physician fee schedule. Lawmakers are unlikely to take on such a major challenge in this election year.
There would be significant opposition and challenges for lawmakers in trying to clear a bill that added an inflation adjustment for what’s already seen as an imperfect physician fee schedule, said Mark E. Miller, PhD, executive vice president of healthcare at the philanthropy Arnold Ventures, which studies how payment decisions affect medical care.
“That bill could cost a lot of money and raise a lot of questions,” Dr. Miller said.
A version of this article appeared on Medscape.com.
Factors Associated with Patient-Reported Treatment Success in PsA
Key clinical point: Improvements in inflammatory arthritis, pain, physical functioning, and the use of tumor necrosis factor (TNF) inhibitors were associated with patient-reported treatment success in patients with psoriatic arthritis (PsA).
Major finding: Increased odds for patient-reported treatment success was seen with TNF inhibitors therapy (odds ratio [OR] 12.86, 95% CI 1.50-110.47), while pain, fatigue, and swollen and tender joint counts reduced the odds of treatment success (OR < 1.00, P < .05). Each point increase in the physical function score was associated with 12%-14% increased odds of treatment success.
Study details: This single-center study included 178 patients with PsA, of which 116 patients reported treatment success.
Disclosures: This study was supported by Celgene; Amgen; Johns Hopkins School of Medicine Biostatistics, Epidemiology and Data Management Core; and others. Two authors declared serving as principal investigators or private consultants for or having other ties with various sources, including Amgen or John Hopkins University. The other authors declared no conflicts of interest.
Source: Samuel C, Finney A, Grader-Beck T, et al. Characteristics associated with patient-reported treatment success in psoriatic arthritis. Rheumatology (Oxford). 2024 (Mar 9). doi: 10.1093/rheumatology/keae149 Source
Key clinical point: Improvements in inflammatory arthritis, pain, physical functioning, and the use of tumor necrosis factor (TNF) inhibitors were associated with patient-reported treatment success in patients with psoriatic arthritis (PsA).
Major finding: Increased odds for patient-reported treatment success was seen with TNF inhibitors therapy (odds ratio [OR] 12.86, 95% CI 1.50-110.47), while pain, fatigue, and swollen and tender joint counts reduced the odds of treatment success (OR < 1.00, P < .05). Each point increase in the physical function score was associated with 12%-14% increased odds of treatment success.
Study details: This single-center study included 178 patients with PsA, of which 116 patients reported treatment success.
Disclosures: This study was supported by Celgene; Amgen; Johns Hopkins School of Medicine Biostatistics, Epidemiology and Data Management Core; and others. Two authors declared serving as principal investigators or private consultants for or having other ties with various sources, including Amgen or John Hopkins University. The other authors declared no conflicts of interest.
Source: Samuel C, Finney A, Grader-Beck T, et al. Characteristics associated with patient-reported treatment success in psoriatic arthritis. Rheumatology (Oxford). 2024 (Mar 9). doi: 10.1093/rheumatology/keae149 Source
Key clinical point: Improvements in inflammatory arthritis, pain, physical functioning, and the use of tumor necrosis factor (TNF) inhibitors were associated with patient-reported treatment success in patients with psoriatic arthritis (PsA).
Major finding: Increased odds for patient-reported treatment success was seen with TNF inhibitors therapy (odds ratio [OR] 12.86, 95% CI 1.50-110.47), while pain, fatigue, and swollen and tender joint counts reduced the odds of treatment success (OR < 1.00, P < .05). Each point increase in the physical function score was associated with 12%-14% increased odds of treatment success.
Study details: This single-center study included 178 patients with PsA, of which 116 patients reported treatment success.
Disclosures: This study was supported by Celgene; Amgen; Johns Hopkins School of Medicine Biostatistics, Epidemiology and Data Management Core; and others. Two authors declared serving as principal investigators or private consultants for or having other ties with various sources, including Amgen or John Hopkins University. The other authors declared no conflicts of interest.
Source: Samuel C, Finney A, Grader-Beck T, et al. Characteristics associated with patient-reported treatment success in psoriatic arthritis. Rheumatology (Oxford). 2024 (Mar 9). doi: 10.1093/rheumatology/keae149 Source
Cytokine Profiles and Response to TNFα Inhibitor And IL-17A Inhibitor In PsA: Any Link?
Key clinical point: Patients with psoriatic arthritis (PsA) who did or did not respond to treatment with tumor necrosis factor alpha inhibitor (TNFi) and interleukin-17A inhibitor (IL-17Ai) showed different profiles of pro- and anti- inflammatory cytokines.
Major finding: At 4 months of follow up, a significant decrease in IL-6 (P = .032) and an increase in IL-10 (P = .010) was seen in patients achieving ≥ 50% improvement in Disease Activity in PsA (DAPSA50) response with TNFi treatment. IL-17Ai treatment showed decrease in IL-1α and IL-27 levels in DAPSA50 responders and increase in IL-17A in both DAPSA 50 responders and non-responders (all P < .05).
Study details: This study included 68 patients with PsA who were initiated with TNFi (n = 29), IL-17Ai (n = 19), or methotrexate (n = 20) treatment and were followed for 4 months.
Disclosure: This study was supported by Eli Lilly and Co., the Danish Rheumatism Association, and others. Two authors declared receiving research funding, speaker fees, and other ties with various sources, including Eli Lilly and the Danish Rheumatism Association. Two authors declared no conflicts of interest.
Source: Skougaard M, Sondergaard MF, Ditlev SB, Kristensen LE. Changes in inflammatory cytokines in responders and non-responders to TNFα inhibitor and IL-17A inhibitor: A study examining psoriatic arthritis patients. Int J Mol Sci. 2024:25(5);3002 (Mar 5). doi: 10.3390/ijms25053002 Source
Key clinical point: Patients with psoriatic arthritis (PsA) who did or did not respond to treatment with tumor necrosis factor alpha inhibitor (TNFi) and interleukin-17A inhibitor (IL-17Ai) showed different profiles of pro- and anti- inflammatory cytokines.
Major finding: At 4 months of follow up, a significant decrease in IL-6 (P = .032) and an increase in IL-10 (P = .010) was seen in patients achieving ≥ 50% improvement in Disease Activity in PsA (DAPSA50) response with TNFi treatment. IL-17Ai treatment showed decrease in IL-1α and IL-27 levels in DAPSA50 responders and increase in IL-17A in both DAPSA 50 responders and non-responders (all P < .05).
Study details: This study included 68 patients with PsA who were initiated with TNFi (n = 29), IL-17Ai (n = 19), or methotrexate (n = 20) treatment and were followed for 4 months.
Disclosure: This study was supported by Eli Lilly and Co., the Danish Rheumatism Association, and others. Two authors declared receiving research funding, speaker fees, and other ties with various sources, including Eli Lilly and the Danish Rheumatism Association. Two authors declared no conflicts of interest.
Source: Skougaard M, Sondergaard MF, Ditlev SB, Kristensen LE. Changes in inflammatory cytokines in responders and non-responders to TNFα inhibitor and IL-17A inhibitor: A study examining psoriatic arthritis patients. Int J Mol Sci. 2024:25(5);3002 (Mar 5). doi: 10.3390/ijms25053002 Source
Key clinical point: Patients with psoriatic arthritis (PsA) who did or did not respond to treatment with tumor necrosis factor alpha inhibitor (TNFi) and interleukin-17A inhibitor (IL-17Ai) showed different profiles of pro- and anti- inflammatory cytokines.
Major finding: At 4 months of follow up, a significant decrease in IL-6 (P = .032) and an increase in IL-10 (P = .010) was seen in patients achieving ≥ 50% improvement in Disease Activity in PsA (DAPSA50) response with TNFi treatment. IL-17Ai treatment showed decrease in IL-1α and IL-27 levels in DAPSA50 responders and increase in IL-17A in both DAPSA 50 responders and non-responders (all P < .05).
Study details: This study included 68 patients with PsA who were initiated with TNFi (n = 29), IL-17Ai (n = 19), or methotrexate (n = 20) treatment and were followed for 4 months.
Disclosure: This study was supported by Eli Lilly and Co., the Danish Rheumatism Association, and others. Two authors declared receiving research funding, speaker fees, and other ties with various sources, including Eli Lilly and the Danish Rheumatism Association. Two authors declared no conflicts of interest.
Source: Skougaard M, Sondergaard MF, Ditlev SB, Kristensen LE. Changes in inflammatory cytokines in responders and non-responders to TNFα inhibitor and IL-17A inhibitor: A study examining psoriatic arthritis patients. Int J Mol Sci. 2024:25(5);3002 (Mar 5). doi: 10.3390/ijms25053002 Source
Bimekizumab More Favorable in PsA than Secukinumab
Key clinical point: Bimekizumab (160 mg/4 weeks) demonstrated favorable efficacy outcomes over secukinumab (150 mg or 300 mg/4 weeks) in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying anti-rheumatic drugs (bDMARD) or had prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: In the bDMARD naive subgroup, the probability of achieving at least 70% improvement in American College of Rheumatology (ACR) response was higher with bimekizumab vs secukinumab (odds ratio > 2; P < .05) at week 52, with similar response in the TNFi-IR subgroup for ACR70 and minimal disease activity outcomes (all P < .05).
Study details: This study included data of bDMARD naive or TNFi-IR patients with PsA who received bimekizumab from BE OPTIMAL (n = 236) and BE COMPLETE (n = 146) and secukinumab from FUTURE 2 trial (n = 200).
Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees and stockholders of UCB Pharma. Several authors declared receiving research grants, and other ties with various sources, including UCB Pharma.
Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and secukinumab in patients with psoriatic arthritis at 52 weeks using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Mar 6). Source
Key clinical point: Bimekizumab (160 mg/4 weeks) demonstrated favorable efficacy outcomes over secukinumab (150 mg or 300 mg/4 weeks) in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying anti-rheumatic drugs (bDMARD) or had prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: In the bDMARD naive subgroup, the probability of achieving at least 70% improvement in American College of Rheumatology (ACR) response was higher with bimekizumab vs secukinumab (odds ratio > 2; P < .05) at week 52, with similar response in the TNFi-IR subgroup for ACR70 and minimal disease activity outcomes (all P < .05).
Study details: This study included data of bDMARD naive or TNFi-IR patients with PsA who received bimekizumab from BE OPTIMAL (n = 236) and BE COMPLETE (n = 146) and secukinumab from FUTURE 2 trial (n = 200).
Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees and stockholders of UCB Pharma. Several authors declared receiving research grants, and other ties with various sources, including UCB Pharma.
Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and secukinumab in patients with psoriatic arthritis at 52 weeks using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Mar 6). Source
Key clinical point: Bimekizumab (160 mg/4 weeks) demonstrated favorable efficacy outcomes over secukinumab (150 mg or 300 mg/4 weeks) in patients with psoriatic arthritis (PsA) who were naive to biologic disease-modifying anti-rheumatic drugs (bDMARD) or had prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: In the bDMARD naive subgroup, the probability of achieving at least 70% improvement in American College of Rheumatology (ACR) response was higher with bimekizumab vs secukinumab (odds ratio > 2; P < .05) at week 52, with similar response in the TNFi-IR subgroup for ACR70 and minimal disease activity outcomes (all P < .05).
Study details: This study included data of bDMARD naive or TNFi-IR patients with PsA who received bimekizumab from BE OPTIMAL (n = 236) and BE COMPLETE (n = 146) and secukinumab from FUTURE 2 trial (n = 200).
Disclosures: This study was sponsored by UCB Pharma. Four authors declared being employees and stockholders of UCB Pharma. Several authors declared receiving research grants, and other ties with various sources, including UCB Pharma.
Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and secukinumab in patients with psoriatic arthritis at 52 weeks using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Mar 6). Source
Real-World Study Confirms Benefits of Guselkumab in Active Longstanding PsA
Key clinical point: Real-world treatment with guselkumab for ≥6 months was effective and safe in patients with longstanding active psoriatic arthritis (PsA) who had median disease duration of 6 years.
Major finding: Disease Activity Index for Psoriatic Arthritis (DAPSA) scores reduced significantly by 15.47 points in guselkumab-treated patients with PsA (P = .001), with 39.6% of patients achieving low disease activity, as assessed by achievement of DAPSA ≤ 14 at 6 months of follow-up. Guselkumab was well tolerated, with no reports of new safety signals.
Study details: This was a prospective real-world cohort study including 111 patients with active, longstanding PsA with a median disease duration of 6 years, who received guselkumab for ≥6 months.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Ruscitti P, Cataldi G, Gentile M, et al. The evaluation of effectiveness and safety of guselkumab in patients with psoriatic arthritis in a prospective multicentre "real-life" cohort study. Rheumatol Ther. 2024 (Mar 4). doi: 10.1007/s40744-024-00649-2 Source
Key clinical point: Real-world treatment with guselkumab for ≥6 months was effective and safe in patients with longstanding active psoriatic arthritis (PsA) who had median disease duration of 6 years.
Major finding: Disease Activity Index for Psoriatic Arthritis (DAPSA) scores reduced significantly by 15.47 points in guselkumab-treated patients with PsA (P = .001), with 39.6% of patients achieving low disease activity, as assessed by achievement of DAPSA ≤ 14 at 6 months of follow-up. Guselkumab was well tolerated, with no reports of new safety signals.
Study details: This was a prospective real-world cohort study including 111 patients with active, longstanding PsA with a median disease duration of 6 years, who received guselkumab for ≥6 months.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Ruscitti P, Cataldi G, Gentile M, et al. The evaluation of effectiveness and safety of guselkumab in patients with psoriatic arthritis in a prospective multicentre "real-life" cohort study. Rheumatol Ther. 2024 (Mar 4). doi: 10.1007/s40744-024-00649-2 Source
Key clinical point: Real-world treatment with guselkumab for ≥6 months was effective and safe in patients with longstanding active psoriatic arthritis (PsA) who had median disease duration of 6 years.
Major finding: Disease Activity Index for Psoriatic Arthritis (DAPSA) scores reduced significantly by 15.47 points in guselkumab-treated patients with PsA (P = .001), with 39.6% of patients achieving low disease activity, as assessed by achievement of DAPSA ≤ 14 at 6 months of follow-up. Guselkumab was well tolerated, with no reports of new safety signals.
Study details: This was a prospective real-world cohort study including 111 patients with active, longstanding PsA with a median disease duration of 6 years, who received guselkumab for ≥6 months.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Ruscitti P, Cataldi G, Gentile M, et al. The evaluation of effectiveness and safety of guselkumab in patients with psoriatic arthritis in a prospective multicentre "real-life" cohort study. Rheumatol Ther. 2024 (Mar 4). doi: 10.1007/s40744-024-00649-2 Source
Guselkumab Superior to Ustekinumab for Joint and Skin Outcomes in PsA
Key clinical point: Guselkumab was more effective than ustekinumab in improving joint and skin outcomes in patients with psoriatic arthritis (PsA), regardless of prior exposure to biologics.
Major finding: A higher proportion of patients with prior exposure to biologics receiving guselkumab (dosage 100 mg/2 weeks or 100 mg/4 weeks) vs ustekinumab (dosage 45/90 mg) achieved the American College of Rheumatology-20 response (> 58% vs 35.6%) and Psoriasis Area Severity Index-90 response (> 50.0% vs 25.9%) at week 52, with similar outcomes in patients naive to biologics.
Study details: This study included pooled individual data from four trials of patients having PsA with (n = 197) or without prior exposure to biologics (n = 1170) who received either guselkumab or ustekinumab.
Disclosures: This study was sponsored by Janssen Research and Development (HEMAR Department, High Wycombe, United Kingdom). All authors reported being employees of Janssen Research and Development or EVERSANA, which received funding from Janssen Research and Development for this study.
Source: Thilakarathne P, Schubert A, Peterson S, et al. Comparing efficacy of guselkumab versus ustekinumab in patients with psoriatic arthritis: An adjusted comparison using individual patient data from the DISCOVER and PSUMMIT trials. Rheumatol Ther. 2024;11:457-474 (Feb 28). doi: 10.1007/s40744-024-00644-7 Source
Key clinical point: Guselkumab was more effective than ustekinumab in improving joint and skin outcomes in patients with psoriatic arthritis (PsA), regardless of prior exposure to biologics.
Major finding: A higher proportion of patients with prior exposure to biologics receiving guselkumab (dosage 100 mg/2 weeks or 100 mg/4 weeks) vs ustekinumab (dosage 45/90 mg) achieved the American College of Rheumatology-20 response (> 58% vs 35.6%) and Psoriasis Area Severity Index-90 response (> 50.0% vs 25.9%) at week 52, with similar outcomes in patients naive to biologics.
Study details: This study included pooled individual data from four trials of patients having PsA with (n = 197) or without prior exposure to biologics (n = 1170) who received either guselkumab or ustekinumab.
Disclosures: This study was sponsored by Janssen Research and Development (HEMAR Department, High Wycombe, United Kingdom). All authors reported being employees of Janssen Research and Development or EVERSANA, which received funding from Janssen Research and Development for this study.
Source: Thilakarathne P, Schubert A, Peterson S, et al. Comparing efficacy of guselkumab versus ustekinumab in patients with psoriatic arthritis: An adjusted comparison using individual patient data from the DISCOVER and PSUMMIT trials. Rheumatol Ther. 2024;11:457-474 (Feb 28). doi: 10.1007/s40744-024-00644-7 Source
Key clinical point: Guselkumab was more effective than ustekinumab in improving joint and skin outcomes in patients with psoriatic arthritis (PsA), regardless of prior exposure to biologics.
Major finding: A higher proportion of patients with prior exposure to biologics receiving guselkumab (dosage 100 mg/2 weeks or 100 mg/4 weeks) vs ustekinumab (dosage 45/90 mg) achieved the American College of Rheumatology-20 response (> 58% vs 35.6%) and Psoriasis Area Severity Index-90 response (> 50.0% vs 25.9%) at week 52, with similar outcomes in patients naive to biologics.
Study details: This study included pooled individual data from four trials of patients having PsA with (n = 197) or without prior exposure to biologics (n = 1170) who received either guselkumab or ustekinumab.
Disclosures: This study was sponsored by Janssen Research and Development (HEMAR Department, High Wycombe, United Kingdom). All authors reported being employees of Janssen Research and Development or EVERSANA, which received funding from Janssen Research and Development for this study.
Source: Thilakarathne P, Schubert A, Peterson S, et al. Comparing efficacy of guselkumab versus ustekinumab in patients with psoriatic arthritis: An adjusted comparison using individual patient data from the DISCOVER and PSUMMIT trials. Rheumatol Ther. 2024;11:457-474 (Feb 28). doi: 10.1007/s40744-024-00644-7 Source
Early PsA Diagnosis May Yield Better Outcomes
Key clinical point: A long delay (>1 year) in diagnosing psoriatic arthritis (PsA) is associated with worse clinical outcomes, especially in women and patients with enthesitis, chronic back pain, and lower C-reactive protein (CRP) levels.
Major finding: Patients with a short (<12 weeks) vs long delay (>1 year) in PsA diagnosis after symptom onset was more likely to achieve minimum disease activity (odds ratio 2.55; 95% CI 1.37-4.76). Female sex, chronic back pain (age < 45 years), enthesitis, and lower CRP levels were associated with a diagnostic delay > 1 year in patients with PsA (all P < .05).
Study details: This study included 708 newly diagnosed patients with PsA who were followed up for ≥3 years; were naive to disease-modifying antirheumatic drugs; and were categorized into groups having short (n = 136), intermediate (12 weeks to 1 year; n = 237), or long (n = 335) delay to diagnosis after symptom onset.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Snoeck Henkemans SVJ, de Jong PHP, Luime JJ, et al. Window of opportunity in psoriatic arthritis: The earlier the better? RMD Open. 2024;10:e004062 (Feb 27). doi: 10.1136/rmdopen-2023-004062 Source
Key clinical point: A long delay (>1 year) in diagnosing psoriatic arthritis (PsA) is associated with worse clinical outcomes, especially in women and patients with enthesitis, chronic back pain, and lower C-reactive protein (CRP) levels.
Major finding: Patients with a short (<12 weeks) vs long delay (>1 year) in PsA diagnosis after symptom onset was more likely to achieve minimum disease activity (odds ratio 2.55; 95% CI 1.37-4.76). Female sex, chronic back pain (age < 45 years), enthesitis, and lower CRP levels were associated with a diagnostic delay > 1 year in patients with PsA (all P < .05).
Study details: This study included 708 newly diagnosed patients with PsA who were followed up for ≥3 years; were naive to disease-modifying antirheumatic drugs; and were categorized into groups having short (n = 136), intermediate (12 weeks to 1 year; n = 237), or long (n = 335) delay to diagnosis after symptom onset.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Snoeck Henkemans SVJ, de Jong PHP, Luime JJ, et al. Window of opportunity in psoriatic arthritis: The earlier the better? RMD Open. 2024;10:e004062 (Feb 27). doi: 10.1136/rmdopen-2023-004062 Source
Key clinical point: A long delay (>1 year) in diagnosing psoriatic arthritis (PsA) is associated with worse clinical outcomes, especially in women and patients with enthesitis, chronic back pain, and lower C-reactive protein (CRP) levels.
Major finding: Patients with a short (<12 weeks) vs long delay (>1 year) in PsA diagnosis after symptom onset was more likely to achieve minimum disease activity (odds ratio 2.55; 95% CI 1.37-4.76). Female sex, chronic back pain (age < 45 years), enthesitis, and lower CRP levels were associated with a diagnostic delay > 1 year in patients with PsA (all P < .05).
Study details: This study included 708 newly diagnosed patients with PsA who were followed up for ≥3 years; were naive to disease-modifying antirheumatic drugs; and were categorized into groups having short (n = 136), intermediate (12 weeks to 1 year; n = 237), or long (n = 335) delay to diagnosis after symptom onset.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Snoeck Henkemans SVJ, de Jong PHP, Luime JJ, et al. Window of opportunity in psoriatic arthritis: The earlier the better? RMD Open. 2024;10:e004062 (Feb 27). doi: 10.1136/rmdopen-2023-004062 Source
Certain Gut Microbiota and Serum Metabolites May Protect Against PsA
Key clinical point: Higher relative abundance of gut microbiota belonging to family Rikenellaceae and an unidentified metabolite X-11538 were associated with a reduced risk for psoriatic arthritis (PsA), highlighting the potential of gut microbiota taxa and metabolites as biomarkers for treatment and prevention of PsA.
Major finding: Adjusted multivariable Mendelian randomization analysis showed that a higher relative abundance of microbiota belonging to the family Rikenellaceae (odds ratio [OR] 0.5; 95% CI 0.320-0.780) and elevated serum levels of X-11538 (OR 0.448; 95% CI 0.244-0.821) were causally associated with a reduced risk for PsA.
Study details: This Mendelian randomization study included summary level data of gut microbiota taxa (n = 18,340), PsA (n = 339,050), and metabolites (n = 7824) from participants included in the MiBioGen consortium, FinnGen Biobank, and TwinsUK and KORA cohorts, respectively.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Xu X, Wu LY, Wang SY, et al. Investigating causal associations among gut microbiota, metabolites, and psoriatic arthritis: A Mendelian randomization study. Front Microbiol. 2024;15:1287637 (Feb 14). doi: 10.3389/fmicb.2024.1287637 Source
Key clinical point: Higher relative abundance of gut microbiota belonging to family Rikenellaceae and an unidentified metabolite X-11538 were associated with a reduced risk for psoriatic arthritis (PsA), highlighting the potential of gut microbiota taxa and metabolites as biomarkers for treatment and prevention of PsA.
Major finding: Adjusted multivariable Mendelian randomization analysis showed that a higher relative abundance of microbiota belonging to the family Rikenellaceae (odds ratio [OR] 0.5; 95% CI 0.320-0.780) and elevated serum levels of X-11538 (OR 0.448; 95% CI 0.244-0.821) were causally associated with a reduced risk for PsA.
Study details: This Mendelian randomization study included summary level data of gut microbiota taxa (n = 18,340), PsA (n = 339,050), and metabolites (n = 7824) from participants included in the MiBioGen consortium, FinnGen Biobank, and TwinsUK and KORA cohorts, respectively.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Xu X, Wu LY, Wang SY, et al. Investigating causal associations among gut microbiota, metabolites, and psoriatic arthritis: A Mendelian randomization study. Front Microbiol. 2024;15:1287637 (Feb 14). doi: 10.3389/fmicb.2024.1287637 Source
Key clinical point: Higher relative abundance of gut microbiota belonging to family Rikenellaceae and an unidentified metabolite X-11538 were associated with a reduced risk for psoriatic arthritis (PsA), highlighting the potential of gut microbiota taxa and metabolites as biomarkers for treatment and prevention of PsA.
Major finding: Adjusted multivariable Mendelian randomization analysis showed that a higher relative abundance of microbiota belonging to the family Rikenellaceae (odds ratio [OR] 0.5; 95% CI 0.320-0.780) and elevated serum levels of X-11538 (OR 0.448; 95% CI 0.244-0.821) were causally associated with a reduced risk for PsA.
Study details: This Mendelian randomization study included summary level data of gut microbiota taxa (n = 18,340), PsA (n = 339,050), and metabolites (n = 7824) from participants included in the MiBioGen consortium, FinnGen Biobank, and TwinsUK and KORA cohorts, respectively.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Xu X, Wu LY, Wang SY, et al. Investigating causal associations among gut microbiota, metabolites, and psoriatic arthritis: A Mendelian randomization study. Front Microbiol. 2024;15:1287637 (Feb 14). doi: 10.3389/fmicb.2024.1287637 Source
Bimekizumab Shows Long-term Benefits in PsA with Inadequate Response or Intolerance to TNFi
Key clinical point: Bimekizumab led to long-term improvements in efficacy outcomes and had a manageable safety profile in patients with active psoriatic arthritis (PsA) and prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: At week 16, a significantly higher number of patients achieved ≥50% improvement in American College of Rheumatology response with bimekizumab vs placebo (43.4% vs 6.8%; P < .0001), with improvements sustained up to week 52 by >40% of patients receiving bimekizumab. No new safety signals were observed.
Study details: Findings are from the BE VITAL open-label extension study including 377 patients with active PsA and TNFi-IR who received bimekizumab or placebo for 16 weeks followed by only bimekizumab up to week 52.
Disclosures: This study was sponsored by UCB Pharma. Four authors reported being employees or shareholders of UCB Pharma. Several authors declared receiving research support or consulting fees or having other ties with various sources, including UCB Pharma.
Source: Coates LC, Landewe R, McInnes IB, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10:e003855 (Feb 22). doi: 10.1136/rmdopen-2023-003855 Source
Key clinical point: Bimekizumab led to long-term improvements in efficacy outcomes and had a manageable safety profile in patients with active psoriatic arthritis (PsA) and prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: At week 16, a significantly higher number of patients achieved ≥50% improvement in American College of Rheumatology response with bimekizumab vs placebo (43.4% vs 6.8%; P < .0001), with improvements sustained up to week 52 by >40% of patients receiving bimekizumab. No new safety signals were observed.
Study details: Findings are from the BE VITAL open-label extension study including 377 patients with active PsA and TNFi-IR who received bimekizumab or placebo for 16 weeks followed by only bimekizumab up to week 52.
Disclosures: This study was sponsored by UCB Pharma. Four authors reported being employees or shareholders of UCB Pharma. Several authors declared receiving research support or consulting fees or having other ties with various sources, including UCB Pharma.
Source: Coates LC, Landewe R, McInnes IB, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10:e003855 (Feb 22). doi: 10.1136/rmdopen-2023-003855 Source
Key clinical point: Bimekizumab led to long-term improvements in efficacy outcomes and had a manageable safety profile in patients with active psoriatic arthritis (PsA) and prior inadequate response or intolerance to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: At week 16, a significantly higher number of patients achieved ≥50% improvement in American College of Rheumatology response with bimekizumab vs placebo (43.4% vs 6.8%; P < .0001), with improvements sustained up to week 52 by >40% of patients receiving bimekizumab. No new safety signals were observed.
Study details: Findings are from the BE VITAL open-label extension study including 377 patients with active PsA and TNFi-IR who received bimekizumab or placebo for 16 weeks followed by only bimekizumab up to week 52.
Disclosures: This study was sponsored by UCB Pharma. Four authors reported being employees or shareholders of UCB Pharma. Several authors declared receiving research support or consulting fees or having other ties with various sources, including UCB Pharma.
Source: Coates LC, Landewe R, McInnes IB, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10:e003855 (Feb 22). doi: 10.1136/rmdopen-2023-003855 Source