At the upcoming American Medical Association (AMA) House of Delegates (HOD) Annual Meeting June 9–14 in Chicago, the ACR will co-lead with the American Society of Clinical Oncology a resolution on in-office dispensing of specialty drugs. Additionally, the ACR authored and will lead 10 other specialty societies to advance a resolution on the proposed NIH Public Access Plan and its potential adverse consequences for equitable access to quality clinical research.
Close to 500 resolutions and reports have been filed for consideration at the AMA’s June HOD meeting, at which delegates from medical specialty societies and state medical associations will set policy and direction for the nation’s largest physician organization. Topics slated to be addressed include: updates to Medicare Physician Fee Schedule payments, budget cuts and budget neutrality issues, approaches to sustaining community practices, biosimilars policies, artificial intelligence in healthcare, prior authorization and many more issues that impact rheumatology and rheumatology practices.
In-Office Specialty Drug Dispensing
The ACR will lead two resolutions at this meeting. First, the ACR has joined with the American Society of Clinical Oncology to advance resolution 246, which would provide protections for practices related to office-based dispensing of specialty drugs.
This resolution would have the AMA request that the Centers for Medicare & Medicaid Services (CMS) rescind its recent determination that delivery of medicine to a patient using the U.S. Postal Service, a commercial package service or a trusted surrogate violates the in-office exception of the physician self-referral law, commonly referred to as the Stark Law. Additionally, if the CMS were to not change its position on disallowing the delivery of medicine to a patient using the U.S. Postal Service or a commercial package service, the resolution would have the AMA call for legislation to clarify that a surrogate may deliver medicine dispensed at a physician-owned pharmacy without being in violation of the Stark Law.
The Stark Law prohibits physicians from making referrals to entities in which they have a financial relationship, unless an exception applies (common exceptions include in-office ancillary services, so that physicians can furnish designated health services to their practice’s patients). In-office dispensing of medication has been associated with improved patient access and adherence. Although the provisions of this resolution will not prevent insurers, PBMs and others from requiring selected delivery mechanisms (such as white bagging, brown bagging, etc.) to drive down costs by restricting patient choice, clarifying this exception to the Stark Law would ensure physician practices that utilize an in-office pharmacy would be able to choose the best delivery method for their individual patients.
NIH Public Access Plan
Additionally, the ACR authored and will lead a resolution titled “NIH Public Access Plan” to raise awareness of possible unintended negative consequences of the planned National Institutes of Health (NIH) pathway. The resolution is cosponsored with 10 other specialty societies. The resolution, if passed, would direct the AMA to work with professional organizations, such as the ACR and other specialty societies, and Congress to raise awareness of and mitigate possible adverse consequences of the proposed NIH Public Access Plan to ensure continued equitable access to quality clinical research.
The concerns of the ACR and other specialty societies stem from changes directed in 2022 by the White House Office of Science & Technology Policy (OSTP), which established new guidance for public access to scholarly publications and data resulting from federally supported research. The OSTP directive requires that peer-reviewed scholarly publications containing any content derived from federal funding, including data on which a study is based, be made immediately available, at no cost, by the end of 2025. This reverses a 2013 policy permitting manuscripts to remain behind a subscription paywall for a one-year period before being accessible for free. The AMA previously had policy that it would work with organizations and Congress to prevent any changes to this policy that would allow public release of NIH research articles within 12 months of publication.
The groups recognize the policy’s intended benefit of making new knowledge as described in published scientific manuscripts immediately available to researchers, scientists and the lay public without a subscription, which in theory could improve efforts to replicate results and the faster application of new scientific and clinical knowledge. However, they also recognize that the NIH plan as proposed might not achieve these goals, due to several likely unintended consequences related to significant changes in business models. These include potential negative consequences in the areas of equity, quality, peer review, scientific record oversight, financial sustainability and the future of scientific research.
In particular, there are concerns the pathway as currently proposed by NIH will encourage a pay-to-publish model that may create substantial inequity in terms of who is able to contribute to the body of peer-reviewed, published scientific research. Necessary changes to business models will likely shift financial responsibility from subscribers to the researchers seeking to have their research published, creating substantial additional barriers for those seeking publication. Many researchers, including junior scientists, who often have limited funds, will find these fees prohibitive. When funds are unavailable, publishing completed work will be delayed or abandoned, hindering the dissemination of new knowledge—precisely the opposite of the desired policy goals.
Additionally, there are concerns about the proposed changes’ impacts on publishers’ ability to maintain meaningful peer review. Diligent peer review, management and public disclosures of conflicts, and data and figure integrity checks are vital parts of the process. Such threats as plagiarism, “paper mills” and fraudulent data are increasingly present and require steady attention. Maintaining this trusted role in society, at a time when disinformation is rampant, requires a significant investment. However, the absence of significant revenue from subscriptions could diminish the incentive for publishers to maintain meaningful peer review. This along with other concerns has the potential to cause significant harm to the viability of the U.S. biomedical research enterprise.
Joining the ACR in raising concerns and calling for AMA involvement through this resolution include: American Academy of Allergy, Asthma and Immunology; American Academy of Neurology; American College of Physicians; American Society of Anesthesiologists; American Society of Hematology; American Society for Radiation Oncology; American Thoracic Society; American Urological Association; Association for Clinical Oncology; and Endocrine Society.
Resolutions are introduced and considered by the ACR based on its positions and policies and the work of ACR committees and the Board of Directors. The ACR’s delegation to the AMA House of Delegates consists of Gary Bryant, MD (Delegate and Delegation Chair), Eileen Moynihan, MD (Delegate), Cristina Arriens, MD (Alternate Delegate), Colin Edgerton, MD (Alternate Delegate), Luke Barre, MD (Young Physician Section representative), Christina Downey, MD (Young Physician Section representative), and Rami Diab, MD (Resident and Fellows Section representative).
The ACR encourages rheumatologists to join or renew membership in the AMA so that this work may continue. Input on the AMA delegation’s work on behalf of the rheumatology community—along with questions or suggestions for this House of Delegates meeting—can be directed to [email protected]. The ACR offers individualized assistance to ACR and ARP members. If you are experiencing specific issues with payers or have other insurance, coding, billing or practice concerns, write to [email protected].
