Category: ACR

ACR Significantly Concerned with MedPAC’s Latest Recommendations to Cut Part B Drug Reimbursement

Posted on by Grayson

The following is a press release from ACR dated June 15, 2023:

The American College of Rheumatology (ACR) today expressed disappointment that the Medicare Payment Advisory Commission (MedPAC) has recommended yet another cut to physician reimbursement for infusing life-altering treatments as part of its June 2023 Report to the Congress: Medicare and the Health Care Delivery System.

In a letter to MedPAC, ACR took issue with the organization’s recommendation to Congress to keep a six percent add-on payment for the lowest-cost drugs, reduce the add-on payment for mid-to-high-level drugs, and add a payment cap for the costliest drugs.

“While we support efforts to rein in the cost of prescription drugs, we firmly believe that this policy would jeopardize provider practices and patients’ health by reducing access to life-changing provider-administered therapies,” said Douglas White, MD, PhD, president of the ACR. “We urge Congress to address the high cost of drugs at the root cause, like the opaque pharmacy benefit manager business practices, and not at the expense of providers.”

In its recommendation, MedPAC asserted that providers prescribe and administer the highest-price medications in order to receive higher reimbursement. ACR firmly rejects this premise. Administering Medicare Part B drugs in provider offices requires rheumatologists to buy the drug in bulk, maintain full-time staff to administer the treatment, and only bill Medicare after it has been given to the patient.

The six percent of the average sales price (ASP) add-on does not incentivize high-cost treatments, but rather offsets the costs of acquiring, storing, and administering treatments. As written, MedPAC’s recommendation would force providers to cut back on offering cutting-edge therapies or offer these medications at a loss, severely limiting patients’ access to medication and threatening practice viability.

“As providers, it is our job to prescribe the most appropriate treatment for our patients. The add-on payments are not considered in our clinical decision-making. We are concerned that policymakers are concentrating on these add-on payments rather than focusing on policies that address the true cause of drug prices,” said Christina Downey, MD, chair of ACR’s Government Affairs Committee. “The ACR will always express concern when provider payments to administer drugs are eschewed by widely supported policies. Hopefully, the bipartisan movement to reform the PBMs industry will yield meaningful change, and patients will see the benefits.”

ACR Endorses Strengthening Medicare for Patients and Providers Act

Posted on by Grayson

The following is a press release issued by the ACR as of yesterday, April 24, 2023:

Today, the American College of Rheumatology (ACR) commended the introduction of the Strengthening Medicare for Patients and Providers Act (H.R. 2474), a bipartisan bill intended to update Medicare physician payments to reflect the impact of the broader economy on physician practices.

The legislation, introduced by Reps. Raul Ruiz, M.D. (D-CA), Larry Bucshon, M.D. (R-IN), Ami Bera, M.D. (D-CA), and Mariannette Miller-Meeks, M.D. (R-IA), would adjust the Medicare Physician Fee Schedule (MPFS) based on inflationary updates measured by the Medicare Economic Index (MEI).

“For too long, specialty providers, like rheumatologists, have faced considerable uncertainty regarding their ability to continue providing needed care to patients,” said Douglas White, MD, PhD, president of the American College of Rheumatology. “The Strengthening Medicare for Patients and Providers Act represents a long-overdue adjustment to the Medicare Physician Fee Schedule that will help stabilize physician practices and ensure that beneficiaries have timely access to rheumatological care.”

The MPFS is the only major fee schedule without an automatic inflationary update. Consequently, Medicare provider reimbursement has failed to keep pace with broader economic realities. Recent analysis from the American Medical Association (AMA) demonstrates that when adjusted for inflation, Medicare physician payments declined 26% from 2001 to 2023, as consumer and practice costs rose.

“This legislation would allow Medicare to more accurately reflect the cost of practicing medicine, which has increased dramatically in recent years,” said Christina Downey, MD, chair of ACR’s Government Affairs Committee. “ACR looks forward to working to advance this important policy reform that will help build a sustainable payment system and protect access to care for patients with serious, chronic diseases.”

ACR: Medicare Drug Pricing Negotiation Methodology Should Include Real-World Experience

Posted on by Grayson

The following is a press release issue by the American College of Rheumatology on April 14, 2023:

The American College of Rheumatology (ACR) today submitted comments to the Centers for Medicare and Medicaid Services (CMS) administrator Chiquita Brooks-LaSure urging that Medicare’s drug price negotiation program balance cost with innovation, incorporate real-world experience from patients and providers, and improve transparency in the program’s methodology.

In its comment letter, the ACR urges CMS to:

  • Ensure that drug pricing timelines and eligibility requirements for negotiating high-spend drugs do not impede innovation and the development of new treatments.
  • Allow greater public participation as the process evolves, including public comment periods of at least 60 or 90 days.
  • Incorporate patient and provider perspectives throughout the process.
  • Make drug negotiation methodologies transparent, accessible, and understandable to all stakeholders.
  • Publish subsequent policies regarding drug price negotiations using the customary regulatory process including a more appropriate public comment period.

“While negotiations toward a maximum fair price are largely between the pharmaceutical industry and CMS, the implications of these negotiations are far-reaching,” said Douglas White, MD, PhD, President of the American College of Rheumatology. “We firmly believe that the real-world experience of patients and prescribers must be integrated into any attempts to identify and negotiate fair drug prices. The ACR appreciates the opportunity to contribute its experience to CMS’s process.”

ACR Urges CMS to Reconsider Copay Assistant Programs in CMS Proposed Rule

Posted on by Grayson

The following is a press release issued by the American College of Rheumatology dated January 31, 2023:

The American College of Rheumatology (ACR) today submitted comments to Centers for Medicare and Medicaid Services (CMS) administrator Chiquita Brooks-LaSure urging the agency to reconsider its current policies on essential copay assistance programs that enable patient access to needed treatments.

Current CMS policy allows insurers to exclude copay assistance from counting toward a patient’s deductible. Copay assistance programs provide patients with financial relief from the high costs associated with many treatments, such as biologics and biosimilar products, upon which they rely to control rheumatic diseases. Without copay assistance, many patients will be unable to pay their deductible, resulting in delays to needed treatment, medication rationing, or forfeiting treatment entirely.

“Rheumatologists care for patients with complex chronic and acute conditions that often require costly treatments. Without vital programs like copay assistance to help them afford treatment, our patients can face irreversible joint and tissue damage as well as serious declines in the quality of their everyday lives,” said Douglas White, MD, PhD, President of the ACR.

The ACR remains deeply concerned about cost-shifting tactics used by health insurers that place a disproportionate financial burden on patients with chronic rheumatic and musculoskeletal conditions like lupus and rheumatoid arthritis. With roughly 95% of expensive specialty medicines having no generic or lower-cost alternative, this proposed rule will leave many rheumatology patients in an untenable position.

“The ACR is deeply concerned that the proposed policies to increase the maximum out-of-pocket limitations, coupled with allowing insurers to exclude copay coupons to be applied toward a patient’s out-of-pocket limit, debilitates our patient’s ability to access the treatments needed to help manage their painful chronic condition,” wrote ACR in its letter. “While we understand the need to find solutions to help curb the increasing cost of healthcare, we cannot support policies that sacrifice our patients’ health in the name of cost savings.”

2022 Specialty Match Day Results Show Strong Appeal of Adult Rheumatology, Ongoing Need to Increase Interest in Pediatric Rheumatology

Posted on by Grayson

The following is a press release from the ACR dated 12-21-2022:

The American College of Rheumatology is pleased to announce another successful recruitment season and welcomes this impressive pool of applicants to the field of rheumatology. 75 percent of the eligible candidates interested in adult rheumatology and 96 percent of eligible applicants interested in pediatric rheumatology were matched to fellowship programs for the 2023 appointment year as part of the annual National Residents Matching Program (NRMP).

Rheumatology leaders again noticed a stark contrast when looking at the percentage of available adult and pediatric fellowship slots that were filled. Whereas the adult programs filled 97.8 percent of their available slots, the pediatric programs only filled 62.8 percent, signaling a need to increase interest in pediatric rheumatology. While the number of adult fellowship matches has seen a steady increase over the past five years, interest from candidates has continued to exceed the number of available positions, suggesting ongoing opportunity to expand fellowship training opportunities. Continuing to make progress in these areas will be important given the workforce shortage projections identified in ACR’s 2015 workforce study.

“This year was the first time that the adult and pediatric fellowship Match dates aligned, allowing participants the opportunity to apply to and rank both adult and pediatric training programs in a single rank list by a dual-trained applicant or by a couple. This change has been welcome, as it facilitates the application process for a number of candidates,” said Beth Marston, MD, chair of the American College of Rheumatology’s (ACR) Committee on Training and Workforce Issues (COTW).

“Unfortunately, we continue to see limited numbers of applications for pediatric rheumatology fellowship positions, with 27 applicants filling only 26 of a possible 43 total positions. Other pediatric specialties such as pediatric pulmonology, nephrology, infectious disease, and endocrinology also had a significant number of unfilled positions; in contrast, the relatively new field of pediatric hospital medicine filled nearly all open positions, which may hint at the goals and training interests of current pediatric applicants. Many potential barriers have been suggested, including inadequate exposure and mentorship within these specialties, long periods of required training, and lower ultimate compensation for pediatric specialists, which might be targets for future work to improve our pediatric specialty workforce,” continued Marston.

“The adult rheumatology workforce also remains threatened, with ongoing national efforts by the ACR’s Workforce Solutions Committee to increase fellowships and fellowship positions, particularly in geographically underserved areas. Because a substantial number of applicants have remained unmatched over the last several years, any increase in the number of available fellowship positions is likely to continue to directly affect the future physician workforce within rheumatology,” Marston concluded.

In addition to efforts to continue to increase fellowship positions, the ACR continues to work to create new mechanisms to increase exposure to rheumatology earlier in training, to understand barriers to training in pediatric and combined internal medicine and pediatrics rheumatology, and to support programs and program directors as they navigate curricular and regulatory changes.

The NRMP, established in 1952 at the request of medical students, uses a computerized, mathematical algorithm to align the preferences of applicants and program directors to fill training positions available at teaching hospitals in the United States. Full details of the 2022 Match Day results for adult and pediatric fellowships can be found online here.

ACR Educating Dermatologists and Nephrologists on Lupus Clinical Trials Racial Disparities

Posted on by Grayson

The following is a press release issued by ACR this morning (Nov 2, 2022).

The American College of Rheumatology (ACR) has released Continuing Medical Education (CME) for dermatologists and nephrologists to help them learn more about clinical trials for lupus patients in their respective treatment areas and the importance of getting more of their African American/Black patients enrolled.

Lupus is a multisystem disease and is frequently managed by a care team including rheumatologists, nephrologists, dermatologists, and other specialists. African American/Black, Hispanics and Native Americans are also disproportionately affected by the condition. This new CME is part of the ACR’s “Materials to Increase Minority Involvement in Clinical Trials” (MIMICT) initiative and is aimed at educating these providers on the importance of increasing minority participation in lupus clinical trials.

“In the United States, African American/Black patients represent approximately 43 percent of lupus cases, however, only 14 percent of lupus clinical trial participants are African American/Black,” said Starla H. Blanks, Senior Director of Collaborative Initiatives for the American College of Rheumatology. “African American/Black patients with lupus. They are also four times more likely to get lupus nephritis, a type of kidney disease, which can increase the mortality rate.”

The new CME provides nephrologists and dermatologists with specific information on racial disparities in lupus clinical trials, why it’s important to increase minority participation in lupus clinical trials, and the barriers providers face when encouraging patients to participate in lupus clinical trials.

“Skin and kidney symptoms are common in lupus patients and there are clinical trials specifically targeting these two organ systems. The CME training addresses barriers like patient mistrust, lack of familiarity with trials, and an intimidating consent process,” said Rosalind Ramsey-Goldman, MD, DrPH, chair of the ACR’s Collaborative Initiatives Committee. “It also addresses facilitators like culturally sensitive communication and social support by emphasizing skills that provide support for both the provider and the patient.”

The new CME for nephrologists and dermatologists can be found on the ACR’s Lupus Initiative website. The expansion of MIMICT was made possible by a two-year grant for the ACR’s Training to Increase Minority Enrollment in Lupus Clinical Trials with CommunitY Engagement (TIMELY) project from the U.S. Department of Health and Human Services Office of Minority Health. More information about the ACR’s work on lupus awareness and educational programs can be found at www.thelupusinitiative.org.

Updated Guideline Introduces Recommendations for Prevention and Treatment of Glucocorticoid-Induced Osteoporosis

Posted on by Grayson

The following is a press release from this past week, care of the ACR.

The American College of Rheumatology (ACR) released a summary of its updated guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis. Many patients take glucocorticoids for a variety of inflammatory conditions, and anyone who is taking glucocorticoid medications and has other risk factors for osteoporosis increases their risk of developing glucocorticoid-induced osteoporosis. New osteoporosis medications and new literature have become available since the last ACR treatment guideline was published in 2017.

“One major side effect of glucocorticoid therapy is bone loss and an increase in the risk of fractures. Fractures can cause significant morbidity and be associated with an increased risk of mortality,” said Mary Beth Humphrey, MD, PhD, co-principal investigator of the guideline and interim Vice President for Research and a Professor of Medicine at the University of Oklahoma Health Sciences Center. “With newly approved osteoporosis medications and a review of the relevant literature, we felt it was important to update the guideline.”

The guideline team conducted an updated systematic literature review for clinical questions on non-pharmacologic and pharmacologic treatment addressed in the 2017 guideline, and for questions on new pharmacologic treatments, discontinuation of medications, sequential and combination therapy.  The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the certainty of evidence. A Voting panel including clinicians and patients achieved ≥70% consensus on the direction (for or against) and strength (strong or conditional) of recommendations.

The guideline includes recommendations on abaloparatide and romosozumab, which are two medications that are newly available since the 2017 guideline, as well as recommendations for other osteoporosis medications.

The guideline also recommends sequential therapy (any treatment regimen in which the patient is given one treatment followed by another), which was not addressed in the previous guideline. The recommendations for sequential therapies are based in part on some study designs, long term follow-up studies, and new clinical trials.

“Some physicians may be surprised about the need for sequential therapy when completing a course of denosumab, parathyroid hormone/parathyroid hormone related protein, or romosozumab. If not done, patients could be at risk of rapidly developing vertebral fractures and bone loss,” said Linda Russell, MD, Director of Perioperative Medicine, Director of the Osteoporosis and Metabolic Bone Health Center for the Hospital for Special Surgery and co-principal investigator of the guideline.

The updated guideline also gives more flexibility on drug selection and considers patient and physician preferences.

“The previous guideline rank-ordered medication for the treatment of glucocorticoid induced osteoporosis. We felt it was important that this guideline reflect patient/physician decision making,” said Dr. Humphrey.

A full manuscript has been submitted for journal peer review and is anticipated to be published in rheumatology journals in early 2023. The summary of the guideline recommendations can be viewed in full on the ACR website.

New Guideline Introduces Recommendations for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases

Posted on by Grayson

The following is a press release from ACR dated today. Also, I helped with this!

New Guideline Introduces Recommendations for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases | Not Standing Still's Disease

The American College of Rheumatology (ACR) released a summary of its new treatment guideline for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases (RMDs). The effectiveness and safety of vaccines may differ in rheumatology patients as compared to the general population. The guideline summary provides recommendations on topics such as broadened indications for some vaccines in patients on immunosuppressants, medication management at the time of vaccination, and safe approaches to the use of live attenuated vaccines in patients on immunosuppressive medications.

“Patients worry about the safety of vaccines and the potential for inducing a disease flare. Providers are concerned whether rheumatic diseases and the medications used to treat them could blunt the effectiveness of vaccines,” said Anne R. Bass, MD, Professor of Clinical Medicine, Hospital for Special Surgery and Weill Cornell Medicine in New York. “They also want to know whether certain vaccines should be given to protect rheumatology patients who are outside the age range for which they are typically recommended. This guideline was designed to address these issues.”

A few highlights of the new guideline include:

  • Pneumococcal vaccination should be administered to all RMD patients taking immunosuppressive medications.
  • Seasonal influenza vaccination should be administered to RMD patients even if their disease is active, they are taking high- dose glucocorticoids, and/or they are on rituximab.
  • Methotrexate should be held for two weeks after influenza vaccination if disease activity allows.
  • In RMD patients on rituximab, vaccines other than influenza should be administered at least 6 months after the last rituximab dose.

One recommendation that differs from current standards is to administer the rotavirus vaccine in the first 6 months of life to infants who have been exposed to tumor necrosis factor (TNF) inhibitors in utero. Rotavirus is a contagious virus that is most common in infants and young children. Currently, pediatricians postpone vaccination in these TNF-inhibitor exposed children until they are a year old.

The guideline also recommends a shorter interval between the last dose of a biologic disease modifying anti-rheumatic drug (DMARD) and administration of a live attenuated (a weakened form of the germ that causes the disease) vaccine.

“This new guideline recognizes that some patients, particularly very young children with autoinflammatory conditions, simply cannot stay off their medications for very long without having a severe flare of their disease. However, those patients still need to get vaccinated,” said Dr. Bass.

The guideline recommends giving the adjuvanted (an ingredient of a vaccine that helps promote a better immune response) influenza vaccination to patients under 65.

“This might come as a surprise to some providers since it hasn’t been directly tested in that age group, but there are no safety signals in the older population,” said Dr. Bass. “There might be concerns about lack of insurance coverage for vaccines recommended outside the typical age range, but the guideline itself will be a useful resource when discussing reimbursement with insurance companies.”

Recommendations for COVID-19 vaccination in RMD patients was not included in the guideline. Readers can refer to the CDC for the most up-to-date recommendations for COVID-19 vaccination, including for patients on immunosuppressive medications. Recommendations about holding immunosuppressive medications at the time of non-live attenuated virus vaccination in this guideline differ from those recommended around the time of COVID-19 vaccination in the ACR COVID-19 Vaccine Guidance.

“This is because prior to the introduction of COVID-19 vaccines in late 2020, there was little population-level immunity to the SARS-CoV-2 virus, and maximizing vaccine efficacy was a public health imperative,” said Dr. Bass.

A full manuscript has been submitted for journal peer review and is anticipated to be published in rheumatology journals in early 2023. The complete summary of the guideline recommendations can be viewed on the ACR website.

ACR Applauds FTC Decision to Investigate PBM Business Practices

Posted on by Grayson

The following is a press release from the American College of Rheumatology:

The American College of Rheumatology applauds the Federal Trade Commission’s decision to investigate the business practices of pharmacy benefit managers (PBMs), which continue to increase PBM profit margins while placing the burden of skyrocketing drug costs on America’s most vulnerable patients, including those living with chronic and severe rheumatic diseases.

This welcomed news follows sustained calls from the rheumatology community for greater oversight over the insurance middlemen who drive up drug costs for our patients. The FTC investigation is a critical step toward greater transparency and oversight over PBMs’ opaque business practices, as well as the enactment of meaningful drug pricing reforms that will reduce costs and expand access to important therapies for our patients.

While PBMs were originally conceived to help manage the complexities of prescription drug benefits, they have since become massive, consolidated, profit-driven enterprises that exercise immense control over our patients’ access to needed treatments. Their business practices are detrimental to policy efforts to curb the high cost of prescription drugs.

The FTC announced today it will examine the role of PBMs, which are hired by insurers to negotiate rebates and fees with drug manufacturers as well as develop drug formularies that impact reimbursement to pharmacies for patient medications. Citing “complicated and opaque methods to determine pharmacy reimbursement, prevalence of prior authorizations and other administrative restrictions and the use of specialty drug lists surrounding specialty drug policies” as some areas of investigation, the FTC noted it has received more than 24,000 public comments to date regarding the potential investigation of PBMs.