Jan. 10, 2025: National Advocacy Update

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a new proposed regulation that modifies the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. 

OCR is endeavoring to further strengthen cybersecurity protections for electronic protected health information (ePHI) by covered entities (most health care providers, health plans, and health care clearinghouses), and their business associates. The HIPAA Security Rule was initially published in 2003 and most recently revised in 2013. 

In light of the ever-increasing cybersecurity threats facing the health care sector, OCR is proposing several updates to the Security Rule’s standards. OCR proposes that Covered Entities and Business Associates provide greater specificity when conducting their security risk analysis, including a written assessment that contains identification of all reasonably anticipated threats to the confidentiality, integrity, and availability of ePHI. The proposal also includes new requirements for planning for contingencies and responding to security incidents, including establishing written procedures to restore the loss of certain relevant electronic information systems and data within 72 hours. In addition, the regulation requires encryption of ePHI, the use of multi-factor authentication, and vulnerability scanning at least every six months and penetration testing at least once every 12 months. 

The AMA is reviewing this proposed regulation. Many of the changes proposed by OCR would be extremely challenging for many physician practices to adopt. Public comments are due by March 7, 2025. 

In response to advocacy by the AMA and many other medical organizations, the U.S. Food and Drug Administration (FDA) recently clarified that current buprenorphine labeling does not require a maximum dose restriction. Currently, the FDA label for many buprenorphine products to treat opioid use disorder (OUD) suggests that doses above 24mg daily have not been shown to be effective. These labels, however, are old and not reflective of the current use of illicitly manufactured fentanyl—or that physicians treating OUD patients are reporting benefits of doses above 24mg for some patients. The FDA is now encouraging submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of OUD. 

The AMA has received multiple reports from physicians that health insurers have been using the current FDA labeling to impose restrictions such as prior authorization, quantity limits, or outright denials on doses of 24mg or higher. These restrictions often prevent patients from accessing buprenorphine at a dose that can effectively manage their OUD, which can have tragic results. Several states also have statutory buprenorphine dose restrictions based on the outdated FDA labeling.  

“Policymakers must take note of these findings and the growing body of evidence that further affirm buprenorphine as a safe, effective, and lifesaving tool in the fight against the illicit fentanyl overdose epidemic,” said Bobby Mukkamala, MD, AMA president-elect and chair of the AMA Substance Use and Pain Care Task Force after a 2024 NIH report on this topic was released. “It is also critically important for health insurance companies, Medicaid, and Medicare to remove dosage caps for buprenorphine. The AMA strongly urges outdated policies be revised to ensure patients with OUD can access lifesaving, evidence-based care. 

In a Dec. 27, 2024, notice in the Federal Register, the FDA agreed that current “labeling for [buprenorphine] products may be misinterpreted by some as establishing a maximum dosage when none exists. FDA is concerned that misinterpretation of these labeling statements may be adversely impacting patients' access to [buprenorphine].” The notice provides the updated FDA-recommended language, including for pregnant individuals.  

The AMA supports the FDA’s efforts to clarify that there is no maximum dose restriction for buprenorphine, and that dosage decisions should be made on an individualized basis. The AMA further urges all payers and states to remove policies that include a maximum dose restriction. 

Last year, the Center for Medicare and Medicaid Innovation (CMMI) announced the creation of a new model to support state Medicaid program efforts to improve maternal health care and pregnancy outcomes. The Transforming Maternal Health (TMaH) model began in 15 states on Jan. 1, 2025: Alabama, Arkansas, California, District of Columbia, Illinois, Kansas, Louisiana, Maine, Minnesota, Mississippi, New Jersey, Oklahoma, South Carolina, West Virginia and Wisconsin. 

The AMA strongly supports efforts to improve maternal and infant health and early on raised concerns (PDF) that the plans for TMaH might not allow it to achieve its objectives. For example, the AMA recommended increasing the funding as each participating state will only receive $17 million over the 10-year model period. The AMA also urged CMMI to prioritize support for small, independent and safety net physician practices and facilities that provide maternity care to underserved rural and urban communities and patients; and to address chronic and acute conditions that cause maternal mortality and morbidity by ensuring physicians and facilities have the resources and support necessary to adopt evidence-based patient safety bundles.

TMaH has a 3-year Pre-implementation Period, during which states receive targeted technical assistance to advance each model element and achieve required pre-implementation milestones, followed by a 7-year Implementation Period to execute the model. More information is available on the CMS website.

On Dec. 27, 2024, the Centers for Medicare & Medicaid Services (CMS) updated the No Surprises Act webpage to reflect the updated certified independent dispute resolution (IDR) entity fees for 2025, which will remain unchanged from 2024 at $200-$840 for single determinations and $268-$1,173 for batched determinations plus an administrative fee of $115 per party per dispute. The specific fees vary by certified IDR entity and can be found listed on the webpage. For additional information and background resources on the No Surprises Act and relevant AMA advocacy efforts, visit our No Suprises Act webpage. 

Change is once again in the air for Washington with the 2024 elections marking the sixth consecutive "change election." Both the U.S. Senate and White House will flip to Republican control in 2025. Democrats had a net gain of 1 seat in the House, but that was not enough for them to retake the majority in that chamber. 

These changes in party control are not the only aspects of the 119th Congress that are noteworthy. Within each chamber of Congress, additional seeds of change have been planted, with more to come. 

South Dakota Senator John Thune assumes the mantles of both party and Majority Leader. He replaces Kentucky Senator Mitch McConnell as GOP leader. New York's Chuck Schumer will remain the Senate's top Democrat as Minority Leader, but other leadership positions and committee rosters shift as the game of musical committee chairs plays out. 

Over in the House, a slim majority maintained by Republicans has been narrowed by departures for the Administration. Elise Stefanik (NY-21) leaves to become Ambassador to the United Nations and Michigander Lisa McClain (MI-10) replaces her as House Republican Conference Chair. While other top roles for both the Republicans and Democrats remain unchanged, committee assignments have been shuffled. 

Could other changes jolt the makeup of Congress in 2025? Who will wield more influence in the 119th Congress? And what does this all mean for health policy? 

This AMA educational session on Jan. 22 at 7:00 p.m. Central time will explore the fluid Congressional landscape, the effect it will have on health care policy in the new Congress, and how you can be an effective advocate in 2025 and beyond. 

With a new administration and new Congress taking the reins at the start of this new year, how is AMA advocacy positioned to effect change on the key issues facing patients and physicians? What opportunities and challenges lie ahead, and how can physicians get involved? 

Join AMA President Bruce A. Scott, MD, for a webinar on Jan. 29 at Noon Eastern/11 a.m. Central to hear the latest, and get a sneak preview of the upcoming AMA National Advocacy Conference in February.

Featured speakers will include: 

• Todd Askew, senior vice president, AMA Advocacy 

• Jason Marino, director of congressional affairs, AMA Advocacy 

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