- AMA comments on FDA generative AI-enabled medical device regulatory considerations
- AMPAC launches interactive Election Hub
- AMA responds to NIH RFI on changes to reporting outcomes from NIH peer review
- New members added to payment model advisory committee
- CMS proposes rule implementing AMA-backed REAL Health Providers Act and PBM reforms
- HHS Cyber Gateway offers physicians free training and resources to strengthen healthcare cybersecurity
- More articles in this issue
AMA comments on FDA generative AI-enabled medical device regulatory considerations
On Oct. 16, the AMA submitted comments (PDF) to the Food and Drug Administration (FDA) regarding the agency’s discussion paper and request for feedback, Considerations for the Regulation of Generative AI-Enabled Medical Devices (PDF). The paper included policy proposals regarding risk assessment, a competency-based approach to premarket evaluation, risk-proportionate postmarket monitoring, and other considerations related to the oversight of generative AI (GenAI)-enabled devices, which present unique regulatory challenges due to the limitless variability of their inputs and outputs.
The FDA proposes a total product life cycle, risk-based approach based on a device’s intended use and technological characteristics, relying on a two-axis framework heuristic considering the level of the device’s independence in directing or taking action relative to the consequences or severity of harm that could result from relying on an incorrect output.
The AMA expressed strong support overall, emphasizing the importance of physician involvement in establishing and evaluating device standards while adding that the agency’s prioritization of regulatory flexibility should not detract from measures necessary to establish a reasonable assurance of safety and effectiveness.
The AMA cautioned that physician supervision should not be presumed to mitigate device risk and that physician expertise should inform the standards for regulatory controls rather than serve as a safety net for potentially unsafe and ineffective GenAI devices. The AMA was supportive of the agency’s proposal for a competency-based approach for premarket evaluation encompassing both device benchmarking and clinical confirmation but stressed that clinician involvement in these processes should not result in accountability for device performance being passed from manufacturers to physicians.
“GenAI has the potential to extend the reach of physicians and fundamentally improve how patients receive care. Realizing that potential requires new approaches to evaluating technologies that can perform increasingly consequential clinical functions,” said AMA President Willie Underwood, MD, MSc, MPH, in a statement on the letter. “Physicians have a critical role in defining what good performance looks like, and the AMA is ready to help build the evidence and oversight frameworks that will allow trustworthy AI that improves care. Manufacturers must remain accountable for the performance of their products, and patients and physicians deserve the confidence that these technologies are safe and effective.”
The FDA is considering feedback from interested parties in developing future draft guidance for GenAI-enabled medical devices.
AMPAC launches interactive Election Hub
AMPAC has launched a new mobile-friendly, interactive Election Hub to help physicians and supporters explore AMPAC’s political activity, supported candidates and voter engagement opportunities. The hub features searchable race and candidate information, a national overview highlighting the geographic reach and bipartisan nature of AMPAC’s support, voter information resources, AMPAC’s independent expenditure efforts, and resources for physicians and other candidates considering elected office. The site is designed to provide a comprehensive view of AMPAC's work to advance AMA's advocacy efforts through political engagement.
AMA responds to NIH RFI on changes to reporting outcomes from NIH peer review
In a recent public response to a National Institutes of Health (NIH) RFI, the AMA urged NIH to retain reporting of overall impact scores and percentile rankings and to establish clear standards for how peer-review results and programmatic priorities inform funding decisions.
In its RFI on Proposed Changes to Reporting Outcomes from NIH Peer Review, the agency proposed replacing the reporting of final overall impact scores and percentile rankings with three broad categories: “Most Competitive,” “Competitive,” and “Not Discussed.” Although expert reviewers would continue to evaluate and score applications under existing procedures, NIH proposed to withhold the final overall impact scores and percentile rankings from applicants, their institutions, NIH program staff, Institute and Center leadership, and advisory councils.
The AMA advocated that NIH preserve expert peer review and accountability in funding decisions. The RFI expressly stated that withholding scores would empower program officials to use their “substantial expertise, portfolio analyses, and good judgment,” to make award recommendations that better reflect NIH's strategic priorities. However, the proposal did not specify the minimum scientific qualifications required of officials exercising this discretion or establish standards for documenting how programmatic considerations justify funding recommendations that depart from expert peer-review rankings.
The AMA's response also asked the NIH to maintain meaningful peer-review feedback for investigators and research institutions, so investigators have information about the relative competitiveness of their applications, helping them interpret peer-review outcomes and decide whether and how to revise and resubmit their proposals.
In addition, the AMA recommended that NIH advance its Unified Funding Strategy through transparent, scientifically grounded award decisions, allowing NIH to achieve the objectives of its strategy while preserving the rigor, independence and transparency of expert peer review.
The AMA response aligned with the positions expressed in a July 10 letter (PDF) to the Office of Management and Budget on Federal Awards, which emphasized that federal grantmaking should be grounded in evidence, statutory purpose and expected public value.
New members added to payment model advisory committee
Six new members have been appointed to the Physician-focused Payment Model Technical Advisory Committee (PTAC) for three-year terms by the Government Accountability Office. The PTAC is an 11-member independent committee created by the Medicare Access and CHIP Reform Act (MACRA) of 2015 to review alternative payment model proposals and make recommendations to the Secretary of Health and Human Services on those that the government should test or implement. Of the six new members, three are physicians:
- AMA Trustee Marta Van Beek, MD, MPH, a board-certified dermatologist and Mohs micrographic surgeon who serves as executive medical director for the University of Iowa Health Care Enterprise
- Jennifer Aloff, MD, FAAFP, a board-certified family physician and owner of Midland Family Physicians who represents family physicians on the AMA/Specialty Society Relative Value Scale Update Committee (RUC)
- Reshma Gupta, MD, MSHPM, chief of population health and accountable care at UC Davis Health
CMS proposes rule implementing AMA-backed REAL Health Providers Act and PBM reforms
On Oct. 16, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule implementing several provisions of the Consolidated Appropriations Act of 2026, including the AMA-backed Requiring Enhanced and Accurate Lists of (REAL) Health Providers Act and new pharmacy benefit manager (PBM) reforms.
Beginning in 2028, the REAL Health Providers Act requires Medicare Advantage (MA) plans to verify provider directory information at least every 90 days for most providers, remove providers who are no longer in-network, and conduct annual assessments of directory accuracy, with public reporting beginning in 2029. The law also protects patients who rely on inaccurate directories to obtain care by limiting their cost sharing to the in-network amount when it is lower. CMS' proposed rule establishes requirements for implementing these protections, including how plans verify directory information, assess accuracy and determine when patients qualify for cost-sharing protections.
Of particular concern, CMS proposes new requirements that would obligate MA plans to include contractual provisions requiring physicians to maintain accurate directory information and furnish documentation of when patients scheduled appointments, with the latter obligation extending at least 10 years after leaving a plan's network. The proposal would also permit plans to rely on repeated outreach to physician practices to verify directory information, potentially creating significant administrative burdens and shifting responsibility for directory accuracy from plans to physicians.
The AMA will submit comments consistent with existing policy, focusing on MA plan accountability for directory accuracy, minimizing administrative burdens on physicians, improving the reliability and transparency of provider network information for patients, and implementing patient cost-sharing protections.
The importance of these reforms was recently highlighted in a New York Times article examining persistent limitations in MA provider directory information. AMA President Willie Underwood III, MD, MSc, MPH, welcomed the forthcoming accuracy requirements and emphasized the importance of plans using information already available to them rather than imposing additional verification burdens on physicians.
Separately, the rule proposes implementing statutory restrictions on PBM compensation and requiring PBMs to report information on drug costs, formulary placement and utilization management practices to Part D sponsors and CMS. The AMA will urge CMS to prevent PBMs from circumventing the compensation restrictions through inflated service fees or affiliate arrangements and to use the new reporting data to assess formulary placement, PA requirements and whether savings are reaching patients through lower out-of-pocket prescription drug costs.
Comments are due Dec. 15, 2026.
HHS Cyber Gateway offers physicians free training and resources to strengthen healthcare cybersecurity
During Cybersecurity Awareness Month, physicians and healthcare organizations should take this opportunity to strengthen their cybersecurity readiness. The AMA encourages physicians to access the Department of Health and Human Services (HHS) Cyber Gateway, a valuable resource available at no cost through the 405(d) Program. Developed through a collaboration between the federal government and healthcare industry stakeholders, the Cyber Gateway serves as a central hub for cybersecurity guidance, tools and educational materials for the healthcare and public health sector. These resources build on the “Cyber Safety is Patient Safety” message, and underscore the critical link between cybersecurity and protecting patient care.
The portal provides a wide range of assets tailored to organizations of all sizes, from small physician practices and clinics to large health systems. Visitors can access the Health Industry Cybersecurity Practices (HICP) publications (PDF), technical guidance documents, resiliency analyses, cybersecurity toolkits, posters, webinars and other materials focused on mitigating today’s most common cyber threats.
The site also features a Knowledge on Demand tab that delivers practical cybersecurity education, including resources on major healthcare cyber threats and quick-learning modules that can help staff improve their awareness and preparedness. All materials are freely available, making it easier for organizations to strengthen their cyber defenses regardless of their budgets.
Healthcare leaders should fully leverage these offerings and consider incorporating the training and educational resources into employee onboarding, annual compliance activities and ongoing cybersecurity awareness programs.
Physicians can also subscribe to the 405(d) mailing list to receive cybersecurity newsletters, advisory bulletins, and updates on emerging threats, ensuring they stay informed in an increasingly complex threat landscape.
