{"id":2385,"date":"2026-11-02T13:16:24","date_gmt":"2026-11-02T13:16:24","guid":{"rendered":"https:\/\/cms.hhs.com\/?p=2385"},"modified":"2026-11-02T13:16:24","modified_gmt":"2026-11-02T13:16:24","slug":"cassidy-releases-healthcare-ai-discussion-draft","status":"publish","type":"post","link":"https:\/\/cms.hhs.com\/index.php\/2026\/11\/02\/cassidy-releases-healthcare-ai-discussion-draft\/","title":{"rendered":"Cassidy Releases Healthcare AI Discussion Draft"},"content":{"rendered":"<p><strong>Cassidy Releases Healthcare AI Discussion Draft<\/strong> \u2013 Senate Health, Education, Labor, and Pensions Committee Chair Bill Cassidy, MD (R-La.) has released a <a href=\"https:\/\/www.help.senate.gov\/imo\/media\/doc\/PATIENT%20AI%20Act%20Discussion%20Draft.pdf\">discussion draft<\/a> of legislation to \u201cdemocratize patient access to AI-based health technologies in a safe and responsible manner.\u201d The Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care Act \u2013 or PATIENT AI Act \u2013 would:<\/p>\n<ul>\n<li>Direct the U.S. Department of Health and Human Services to further implement AI in its internal processes and release guidance to ensure that AI deployment protects patient privacy and security;<\/li>\n<li>Clarify when an AI-based technology is subject to oversight by the Food and Drug Administration (FDA) or the Office of the National Coordinator for Health Information Technology;<\/li>\n<li>Grant the FDA new authorities to review changes to software on a rolling basis; and<\/li>\n<li>Create a payment pathway to support greater adoption of AI-based tools.<\/li>\n<\/ul>\n<p>Cassidy is requesting stakeholder feedback on the proposal be submitted to <a href=\"mailto:patientai@help.senate.gov\">patientai@help.senate.gov<\/a> no later than December 1, 2026.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Pallone Requests GAO Investigation into TrumpRx \u2013 <\/strong>House Energy and Commerce Committee Ranking Member Frank Pallone (D-N.J.) has <a href=\"https:\/\/democrats-energycommerce.house.gov\/sites\/evo-subsites\/democrats-energycommerce.house.gov\/files\/evo-media-document\/2026.10.27.gao_.letter-re-trumprx.pdf\">requested<\/a> that the Government Accountability Office (GAO) conduct a review of TrumpRx.gov. \u201cThe Trump Administration has claimed that TrumpRx has generated substantial new savings for American patients,\u201d Pallone writes, \u201cHowever, it has failed to disclose critical information allowing the public to scrutinize those claims.\u201d He asks that the GAO analyze whether and how the platform tracks TrumpRx usage and whether it is possible to calculate what, if any, savings it has provided for Americans.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Wyden, Sanders Query Insurers on Marketplace Disenrollments \u2013 <\/strong>Twelve Democratic senators led by Senate Finance Committee Ranking Member Ron Wyden (D-Ore.) and HELP Committee Ranking Member Bernie Sanders (I-Vt.) have <a href=\"https:\/\/www.wyden.senate.gov\/imo\/media\/doc\/10262026wydensanderssenatedemocratsacadisenrollmentscignaletter.pdf\">written<\/a> to the nation\u2019s major health insurance companies asking about their involvement in the Trump administration\u2019s decision to disenroll 760,000 marketplace patients due suspected fraud. Letters were sent to Cigna, UnitedHealthcare, Centene, AmeriHealth Caritas, Elevance, Florida Blue, Oscar Health, Molina Healthcare, Health Care Service Corporation, and Imperial Insurance Companies. \u201cAligning with Republicans and their so-called \u2018war on fraud,\u2019 insurance companies chose to participate in a collaborative effort with the Trump administration to inject yet more chaos and damage into the Affordable Care Act marketplace,\u201d the senators wrote. The administration has stated that the terminations were in response to phantom enrollment of people without their knowledge or consent, or of individuals otherwise ineligible for coverage.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Senators Push Back on New Nursing Home Inspection Policy \u2013 <\/strong>Four Democratic senators are <a href=\"https:\/\/www.warren.senate.gov\/wp-content\/uploads\/2026\/10\/Letter-to-CMS-Administrator-Oz-re-Risk-Based-Surveys-in-Nursing-Homes.pdf\">requesting<\/a> information by November 9 from the Trump administration about a policy that they argue would result in thousands of nursing homes going without an annual inspection. The letter, signed by Sens. Elizabeth Warren (D-Mass.), Mazie Hirono (D-Hawaii), Kirsten Gillibrand (D-N.Y.), and Richard Blumenthal (D-Conn.), raises concerns about the Centers for Medicare and Medicaid Services\u2019 (CMS) recently implemented Risk-Based Survey (RBS) program, which would limit the number and scope of required federal and state nursing home inspections. \u201cCMS has adopted the RBS against a broader backdrop of rolled-back nursing home standards, including the elimination of new minimum staffing standards and delays to nursing home financial transparency requirements. These actions already place nursing home residents at risk \u2014 and the new policy of limited surveys will only make matters worse,\u201d the lawmakers argue.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Sen. Chris Murphy Hospitalized Following Stroke<\/strong> \u2013 Sen. Chris Murphy (D-Conn.) was hospitalized on Saturday afternoon after experiencing a stroke. Murphy has been transferred to Johns Hopkins for further monitoring. According to a statement from the senator\u2019s chief of staff, he is responding well to treatment and is awake and alert. Sen. Murphy serves on the Senate HELP Committee and Appropriations Committee.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Trump Administration Finalizes New PBM Transparency, Reporting Requirements \u2013 <\/strong>The Department of Labor has finalized a <a href=\"https:\/\/www.federalregister.gov\/documents\/2026\/11\/02\/2026-22306\/improving-transparency-into-pharmacy-benefit-manager-fee-disclosure\">regulation<\/a> to implement pharmacy benefit manager (PBM) reforms within large, self-insured ERISA health plans.\u00a0 The provisions in this final rule, which stems from the Consolidated Appropriations Act of 2026, require PBMs to provide ERISA plan fiduciaries with detailed information on pricing, rebates, discounts, and benefit design. This information is intended to help the fiduciaries select a PBM and ensure compliance with the new rule. The regulation applies to ERISA health plans that begin on or after July 1, 2027. The final rule specifically requires PBMs to:<\/p>\n<ul>\n<li>Submit a report to ERISA plan fiduciaries focused on the services provided, the compensation received, and the arrangements with other parties in the pharmaceutical supply chain when an initial contract is signed and again on a semiannual basis;<\/li>\n<li>Report on all compensation, including drug manufacturer payments, spread pricing, copay claw-backs, and incentives related to formulary placement or price protection agreements; and<\/li>\n<li>Allow plan fiduciaries to audit their PBM at least once per year to verify the accuracy of the disclosures.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>HHS Solicits Nominations for ACIP \u2013 <\/strong>The U.S. Department of Health and Human Services (HHS) is <a href=\"https:\/\/www.federalregister.gov\/documents\/2026\/10\/30\/2026-22185\/solicitation-of-nominations-for-appointment-to-the-advisory-committee-on-immunization-practices\">soliciting<\/a> nominations for the Advisory Committee on Immunization Practices (ACIP). The notice specifically calls for nominations representing a \u201cbalanced range of scientific, clinical, and public health expertise relevant to the committee\u2019s mission, including person(s) knowledgeable about consumer perspectives and\/or social and community aspects of immunization programs.\u201d Nominations will be accepted through December 31, 2026. ACIP, which typically meets three times a year, has not met since December 2025 due to ongoing litigation around HHS Secretary Robert F. Kennedy Jr.\u2019s appointment of new members to the panel. The solicitation of new nominees could allow the committee to resume its work early next year.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>ARPA-H Director Placed on Administrative Leave \u2013 <\/strong>Alicia Jackson, PhD, director of the Advanced Research Projects Agency for Health (ARPA-H), has been placed on administrative leave. Jackson, a former health technology industry executive, has led ARPA-H for a little more than a year. She had previously sought a limited conflict of interest waiver based on her financial interests, but it remains unclear whether the waiver has been finalized or granted. ARPA-H chief medical officer Rafid Fadul, MD, MBA is assuming the duties of director in Jackson\u2019s absence as the U.S. Department of Health and Human Servies resolves issues in her ethics clearance process.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Recently Introduced Health Legislation<\/strong><\/p>\n<p>H.R.10908 \u2014To implement Universal Savings Accounts and expand transparency, competition, and patient rights in health care; Sponsor: Cloud, Michael [Rep.-R-TX-27]; Committees: House &#8211; Energy and Commerce; Ways and Means<\/p>\n<p>&nbsp;<\/p>\n<p>H.R.10919 \u2014 To amend title III of the Public Health Service Act to ensure that certain safety net providers are not required to pay more than the 340B ceiling price for covered outpatient drugs at the time of purchase; Sponsor: Bergman, Jack [Rep.-R-MI-1]; Committees: House &#8211; Energy and Commerce<\/p>\n<p>&nbsp;<\/p>\n<p>H.R.10920 \u2014 To amend the Public Health Service Act to reauthorize a program under which the Secretary of Health and Human Services makes grants to State professional licensing boards for the development and implementation of policies to reduce statutory and regulatory barriers to telemedicine, and for other purposes; Sponsor: Cammack, Kat [Rep.-R-FL-3]; Committees: House &#8211; Energy and Commerce<\/p>\n<p>&nbsp;<\/p>\n<p>H.R.10921 \u2014 To amend title XVIII of the Social Security Act to provide coverage for custom fabricated breast prostheses following a mastectomy; Sponsor: Chu, Judy [Rep.-D-CA-28]; Committees: House &#8211; Energy and Commerce; Ways and Means<\/p>\n<p>&nbsp;<\/p>\n<p>H.R.10923 \u2014To amend the Controlled Substances Act to better align such Act with modern medical knowledge, establish a new system for the scheduling of controlled substances, redelegate certain authorities, promote scientific research, and for other purposes; Sponsor: Cohen, Steve [Rep.-D-TN-9]; Committees: House &#8211; Energy and Commerce; Judiciary; Oversight and Government Reform; Natural Resources; Agriculture; Transportation and Infrastructure<\/p>\n<p>&nbsp;<\/p>\n<p>H.R.10924 \u2014 To amend the Social Security Act to establish a Medicare for America health program to provide for comprehensive health coverage for all Americans; Sponsor: DeLauro, Rosa L. [Rep.-D-CT-3]; Committees: House &#8211; Ways and Means; Energy and Commerce; Judiciary; Natural Resources; Education and Workforce; House Administration<\/p>\n<p>&nbsp;<\/p>\n<p>H.R.10933 \u2014 To amend the Public Health Service Act to direct the Secretary of Health and Human Services to make grants to eligible entities for activities related to emergency medical services, and for other purposes; Sponsor: Kean, Thomas H. [Rep.-R-NJ-7]; Committees: House &#8211; Energy and Commerce<\/p>\n<p>&nbsp;<\/p>\n<p>H.R.10937 \u2013 To amend title XXVII of the Public Health Service Act to ensure the equitable treatment of covered entities and pharmacies participating in the 340B drug discount program, and for other purposes; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House &#8211; Energy and Commerce; Ways and Means<\/p>\n<p>&nbsp;<\/p>\n<p>H.R.10938 \u2014 To amend title 38, United States Code, to increase the maximum amount of a home health service benefit available to certain veterans under the laws administered by the Secretary of Veterans Affairs; Sponsor: Miller, Max L. [Rep.-R-OH-7]; Committees: House &#8211; Veterans&#8217; Affairs<\/p>\n<p>&nbsp;<\/p>\n<p>H.R.10945 \u2014To amend title XI of the Social Security Act to exclude from the anti-kickback statute and other sanctions certain remunerations for providing food or nutrition services to individuals; Sponsor: Sykes, Emilia Strong [Rep.-D-OH-13]; Committees: House &#8211; Energy and Commerce; Ways and Means<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cassidy Releases Healthcare AI Discussion Draft \u2013 Senate Health, Education, Labor, and Pensions Committee Chair Bill Cassidy, MD (R-La.) has released a discussion draft of legislation to \u201cdemocratize patient access to AI-based health technologies in a safe and responsible manner.\u201d The Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care Act \u2013 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/cms.hhs.com\/index.php\/2026\/11\/02\/cassidy-releases-healthcare-ai-discussion-draft\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Cassidy Releases Healthcare AI Discussion Draft&#8221;<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[8],"tags":[13,15],"issue":[],"class_list":["post-2385","post","type-post","status-publish","format-standard","hentry","category-weekly-policy-briefing","tag-legislative-updates","tag-regulatory-updates"],"_links":{"self":[{"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/posts\/2385","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/comments?post=2385"}],"version-history":[{"count":1,"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/posts\/2385\/revisions"}],"predecessor-version":[{"id":2387,"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/posts\/2385\/revisions\/2387"}],"wp:attachment":[{"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/media?parent=2385"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/categories?post=2385"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/tags?post=2385"},{"taxonomy":"issue","embeddable":true,"href":"https:\/\/cms.hhs.com\/index.php\/wp-json\/wp\/v2\/issue?post=2385"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}