- 120+ physician organizations support Improving Seniors’ Timely Access to Care Act
- FDA announces TEMPO pilot for digital health devices
- AMA urges CMS to protect patients with pain
- AMA joins more than 100 physician and provider organizations to ask HHS to withdraw HIPAA Security Proposed Rule
- More articles in this issue
120+ physician organizations support Improving Seniors’ Timely Access to Care Act
On Dec. 9, more than 120 national medical specialty societies and state medical associations joined an AMA-led letter (PDF) to congressional leadership in support of H.R. 3514/S. 1816, the Improving Seniors’ Timely Access to Care Act. AMA’s long-standing support of this bipartisan, bicameral legislation to reform prior authorization in Medicare Advantage (MA) spans numerous years and Congressional sessions.
The Improving Seniors’ Timely Access to Care Act is dedicated to reducing physician administrative burden and unnecessary delays in patient care by facilitating the expansion of electronic prior authorization solely for “items and services” in MA. The bill, which currently has a majority of the House of Representatives (238) and a super majority of the Senate (63) as cosponsors, incorporates all the major elements of a 2018 consensus statement (PDF) developed by leading physician, hospital, medical group, health plan and pharmacy stakeholders.
More specifically, the legislation would:
- Require MA plans to implement electronic prior authorization programs that adhere to newly developed federal standards and are capable of seamlessly integrating into electronic health systems (vs. proprietary health plan portals).
- Mandate that plans report to CMS on the extent of their use of prior authorization and the rate of approvals and denials.
- Provide a pathway for CMS to study and institute real-time decisions for routinely approved items and services.
- Clarify CMS’ authority to establish timeframes for electronic prior authorization request approvals, including expedited deadlines for emergent services.
- Require the Department of Health and Human Services (HHS) and other agencies to report to Congress on program integrity efforts and other ways to further improve the electronic prior authorization process.
The letter also features the results of a 2024 AMA national survey (PDF) including that “93 percent of physicians cited care delays linked to prior authorization, 82 percent reported that it sometimes causes patients to abandon recommended treatment, and almost one in three physicians witnessed prior authorization leading to a serious adverse event for a patient, including hospitalization, disability, or death.”
Representatives Mike Kelly (R-PA), Suzan DelBene (D-WA), Ami Bera, MD (D-CA), and John Joyce, MD (R-PA), introduced H.R. 3514 in the House of Representatives, while Senators Roger Marshall, MD and Mark Warner (D-VA) are the lead sponsors of S. 1816. AMA will continue to push bipartisan, bicameral members of Congress to expeditiously enact the Improving Seniors’ Timely Access to Care Act.
FDA announces TEMPO pilot for digital health devices
On Dec. 5, the U.S. Food and Drug Administration (FDA) announced the Technology-Enabled Patient Outcomes for Digital Health Services (TEMPO) pilot, a program aimed at enabling the success of the Advancing Chronic Care with Effective, Sustainable Solutions (ACCESS) model announced by CMS on Dec. 1. The ACCESS model is a voluntary initiative to test technology-supported care for Medicare beneficiaries with chronic conditions.
The FDA TEMPO model is a voluntary pilot offering a new, risk-based enforcement approach to support use of certain digital health devices. Developed in collaboration with CMS to support the ACCESS model, devices intended to provide care under the model may request that FDA exercise enforcement discretion for certain FDA requirements, such as FDA pre-market review. If granted enforcement discretion, manufacturers of these devices must collect, monitor, and report real-world performance data to help both FDA and CMS better understand performance of these technologies in real-life settings. Manufacturers of devices intended to improve cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions within the ACCESS model will be eligible to apply for the TEMPO pilot.
The AMA issued a statement of support for the ACCESS model, with AMA CEO John Whyte, MD, MPH, stating that “ACCESS is an important step toward bringing new, effective digital health tools into everyday care for Medicare patients.” The AMA will continue to monitor the implementation of both the ACCESS model and TEMPO pilot and will continue to support efforts that allow for greater incorporation of innovative technologies into clinical care.
AMA urges CMS to protect patients with pain
The AMA sent a letter (PDF) urging CMS to rescind proposed Local Coverage Determinations (LCDs) for Peripheral Nerve Blocks (PNBs) and Procedures for Chronic Pain to avoid patient harm and preserve physicians’ ability to provide optimal pain care to their patients. The AMA asked CMS (PDF) to direct multiple Medicare Administrative Contractors (MACs) to rescind the LCDs so that physicians are not placed in a potentially ethically and clinically compromised position.
Without being able to recommend evidence-based PNBs (e.g. Greater Occipital Nerve Blocks, Stellate Ganglion Block and Sympathetic Blocks, Lateral Femoral Cutaneous Nerve Blocks and Ilioinguinal and Iliohypogastric Nerve Blocks), “physicians would not be able to recommend what is optimal and be forced to try other treatments including opioid therapy or other pharmacologic or non-pharmacologic options,” the AMA wrote in the letter. “Patients, as a result, would likely face higher risks, increased potential for complications, and sub-optimal pain relief.”
AMA joins more than 100 physician and provider organizations to ask HHS to withdraw HIPAA Security Proposed Rule
In a Dec. 8 letter (PDF) to HHS Secretary Robert F. Kennedy, Jr., the AMA joined other physician and provider organizations asking HHS to withdraw the Health Insurance Portability and Accountability Act (HIPAA) Security Proposed Rule issued in January 2025. The signatories instead encouraged HHS to conduct a collaborative outreach initiative with providers and other regulated entities to produce a HIPAA Security Rule that offers more robust protections of individuals’ health information but is less burdensome and costly for health care providers and other stakeholders.
The letter reaffirms a firm conviction for the importance of HIPAA and the cybersecurity safeguards it provides but raises the proposal’s substantial new financial burdens on providers as well as the unreasonable implementation timelines that make it difficult to reconcile the rule’s new requirements with the information technology complexities of modern health care delivery organizations. The letter also contends that any update to health care cybersecurity standards must be flexible enough to accommodate a wide range of provider organizations and set strong protections that allow providers opportunities to innovate to respond effectively to evolving cybersecurity risks.
The AMA submitted a comment letter (PDF) on the Proposed Rule in March 2025 that discussed how the proposal required substantial revision and should not be finalized in its current iteration.
