Health Care Week in Review | CMS Announces Optional Medicaid Community Engagement Requirement Hold Harmless Period Through June 30, 2027, and Extends Home Health, Hospice Enrollment Moratorium

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news. 

Regulations, Notices & Guidance

• On November 9, 2026, the Food and Drug Administration (FDA) released final guidance entitled, Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff. This final guidance describes general recommendations for the validation of in vitro diagnostic devices (IVDs) for emerging pathogens during an applicable declaration of public health emergency (PHE). This guidance and the associated template include the recommendations that apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered as described in an applicable enforcement discretion policy.
• On November 10, 2026, the National Institutes of Health (NIH) released a notice entitled, Privacy Act of 1974; System of Records. In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is publishing notice of modifications to an existing system of records maintained by the NIH entitled, Administration: National Library of Medicine, User Services and Collection Division (NIH Library). The modifications affect the: System name, Routine uses, System location, System manager(s), Purpose of the system, Categories of individuals covered, Categories of records, Retention and disposal, Policies and practices for retrieval, and Record source categories.
• On November 10, 2026, FDA released a request for information (RFI) entitled, Patient-Level Data for Drugs and Biological Products Submissions Containing Real-World Data and Real-World Evidence. FDA is announcing an RFI to solicit input from interested parties on innovative solutions to address the challenges in submitting patient-level data for real-world data (RWD) analyzed in clinical studies included in a marketing application. Interested parties may include regulated industry, health information technology (HIT) vendors, academic medical centers, electronic data capture vendors, patient advocates, and other interested parties. Comments are due January 11, 2027.
• On November 10, 2026, FDA released draft guidance entitled, Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry. The purpose of this draft guidance is to provide recommendations to sponsors and clinical investigators developing early-phase trials, which include first-in-human (FIH) protocols or protocols for drugs and biologic products with limited human experience, submitted under an Investigational New Drug Application (IND) to the appropriate disease-specific division located within the Office of Oncologic Diseases (OOD) in the Center for Drug Evaluation and Research (CDER) and the Office of Clinical Evaluation (OCE) in the Center for Biologics Evaluation and Research (CBER.) This draft guidance is specific to solid tumors and does not address protocols for investigational drugs intended to treat hematologic malignancies. Comments are due January 11, 2027.
• On November 12, 2026, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Order under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right to Introduce Certain Persons from Countries Where a Quarantinable Communicable Disease Exists. CDC is announcing that it is issuing an order under Sections 362 and 365 of the Public Health Service Act, and associated implementing regulations, continuing the suspension of the right to introduce certain persons from countries where an outbreak of a quarantinable communicable disease exists. This order was issued on November 10, 2026, and will remain in effect through Thursday, December 10, 2026.
• On November 13, 2026, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension and Modification of the Nationwide Temporary Moratorium on Enrollment of Home Health Agencies (HHAs). CMS is announcing the extension and modification of the nationwide temporary moratorium on the enrollment of new Medicare Home Health Agencies (HHAs) initially imposed on May 13, 2026. The moratorium extension will only apply to initially enrolling HHAs. The extension will not apply to additions of HHA branches, and the moratorium on the addition of branches by currently enrolled HHAs will end as of November 12, 2026, the effective date of this notice.
• On November 12, 2026, CMS released a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension and Modification of the Nationwide Temporary Moratorium on Enrollment of Hospices. CMS is announcing the extension and modification of the nationwide temporary moratorium on the enrollment of new Medicare hospices initially imposed on May 13, 2026. The moratorium extension will only apply to initially enrolling hospices. The extension will not apply to additions of hospice practice locations, and the moratorium on the enrollment of new practice locations by currently enrolled hospices will end as of November 12, 2026, the effective date of this notice.
• On November 12, 2026, CMS released a notice entitled, Privacy Act of 1974; Matching Program. In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, CMS is providing notice of a new matching program between CMS and the U.S. Department of Education (ED). The matching program supports eligibility determinations for enrollment in applicable State health subsidy programs under the Patient Protection and Affordable Care Act (ACA), including Qualified Health Plans (QHPs), Medicaid, the Children's Health Insurance Program (CHIP), and Basic Health Programs (BHPs). The matching program also supports implementation of statutory requirements concerning Medicaid community engagement and the prevention of concurrent Medicaid enrollment in more than one State through the Multi-State Enrollment Prevention (MSEP) system.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event. 

• November 16, 2026: NIH announced a meeting of the Sickle Cell Disease Advisory Committee. This is a virtual meeting open to the public.
• November 18, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is a virtual meeting open to the public.
• November 19, 2026: FDA announced a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. This is a hybrid meeting open to the public.
• November 20, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Diabetes and Digestive and Kidney Diseases (NIDDK). This is a virtual meeting with some sessions open to the public.
• **November 20, 2026: NIH announced a meeting of the Interagency Autism Coordinating Committee (IACC). This is a virtual meeting open to the public.
• December 2, 2026: NIH announced a meeting of the National Cancer Advisory Board. This is a virtual meeting with some sessions open to the public.
• December 2, 2026: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This is a virtual meeting open to the public.
• December 2, 2026: NIH announced a meeting of the NCI. This is a virtual meeting with some sessions open to the public.
• December 2, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a virtual meeting open to the public.
• December 3, 2026: NIH announced a meeting of the Sleep Disorders Research Advisory Board (SDRAB). This is a virtual meeting open to the public.
• December 6-7, 2027: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD). This is a hybrid meeting open to the public.
• December 7-8, 2026: NIH announced a meeting of the NICHD. This is a hybrid meeting open to the public.
• December 8, 2026: The Internal Revenue Service (IRS) announced a hearing on the proposed regulations amending an individual taxpayer’s eligibility for a Premium Tax Credit (PTC). This is a telephonic meeting open to the public.
• December 8-9, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
• December 9-10, 2026: CMS announced a town hall meeting to discuss fiscal year (FY) 2028 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). This is a virtual meeting open to the public.
• January 16, 2027: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). This is a virtual meeting open to the public.
• January 20, 2027: NIH announced a meeting of the NIDDK Advisory Council. This is a virtual meeting with some sessions open to the public.
• January 21, 2027: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is a virtual meeting with some sessions open to the public.
• January 25-26, 2027: NIH announced a meeting of the NICHD. This is a virtual meeting with some sessions open to the public.
• January 26, 2026: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a virtual meeting with some sessions open to the public.
• January 26-27, 2027: NIH announced a meeting of the National Institute of Aging. This is a virtual meeting with some sessions open to the public.
• February 8-9, 2027: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• February 19, 2027: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• May 3-4, 2027: NIH announced a meeting of the NICHD. This is a virtual meeting with some sessions open to the public.
• **May 4-6, 2027: NIH announced a meeting of the Board of Scientific Counselors, National Institute on Aging. This is a hybrid meeting with some sessions open to the public.
• May 11-12, 2027: NIH announced a meeting of the National Advisory Council on Aging. This is an in-person meeting with some sessions open to the public.
• May 12, 2027: NIH announced a meeting of NIDDK. This is a hybrid meeting with some sessions open to the public.
• May 18, 2027: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is a hybrid meeting with some sessions open to the public.
• June 4, 2027: NIH announced a meeting of the NICHD. This is a virtual meeting with some sessions open to the public.
• June 7, 2027: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• June 7-8, 2027: NIH announced a meeting of the NICHD. This is an in-person meeting with some sessions open to the public.
• June 25, 2027: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• September 7-8, 2027: NIH announced a meeting of the NICHD. This is an in-person meeting with some sessions open to the public.
• September 9-10, 2027: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 14, 2027: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is a hybrid meeting with some sessions open to the public.
• September 14-15, 2027: NIH announced a meeting of the National Institute of Aging. This is a hybrid meeting with some sessions open to the public.
• October 15, 2027: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• **October 19-21, 2027: NIH announced a meeting of the Board of Scientific Counselors, National Institute on Aging. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

OIG Finds Gaps in CMS Oversight of Medicare Cost Report Settlements

On November 10, 2026, the HHS Office of Inspector General (OIG) released a report entitled, CMS’s Oversight of Medicare Administrative Contractors’ (MACs) Cost Report Settlement Processes Was Not Adequate To Identify Settlements That Contained Obvious Errors and That Had Inadequate Supervisory Review. Previous OIG audits identified that MACs performed audits and desk reviews of annual cost reports submitted by Medicare-certified providers and reopened certain final settlements to correct them because of errors or inconsistencies with the law, regulations, or Medicare manual instructions. This report summarizes the results of six previous audits of reopened and corrected cost report final settlements to determine whether CMS’s oversight of MACs’ cost report settlement processes was adequate. OIG identified 234 cost report reopenings that resulted in corrected final settlements to providers totaling $31.6 million, which consisted of $23.3 million in overpayments and $8.3 million in underpayments. OIG found that of the 234 cost report reopenings with settlement errors that OIG’s previous audits identified, CMS’s quality assurance process had identified only eight cost reports as having had settlement errors. OIG recommended that CMS enhance the oversight activities of its quality assurance process, require MACs to submit annual reports on the numbers and types of errors they identify in final settlements of cost reports, and instruct MACs to create a quality assurance review of cost reports that have had either an audit or a desk review only.

Other Health Policy News

Senator Sanders Outlines Medicare-for-All Priorities for Next Congress

On November 8, 2026, current Senate Health, Education, Labor, & Pensions (HELP) Ranking Member Bernie Sanders (I-VT) announced, via a post on X, his proposal to work towards Medicare-for-All in the upcoming 120^th Congress. He wrote that the “immediate first step” should be to lower the Medicare age of eligibility to 55, ensure all children are covered, and expand existing Medicare benefits to include dental, vision, and hearing services. Medicare primarily provides health insurance coverage to Americans aged 65 and older, though certain younger individuals may qualify under specific circumstances.

Senator Sanders’ post on X may be found here.

Senator Wyden Sets Senate Finance Health Care Priorities

On November 9, 2026, Senate Finance Committee Ranking Member Ron Wyden (D-OR) announced that the top health care priorities for the Senate Finance Committee next Congress will be to repeal the cuts to Medicaid passed in H.R. 1, the One Big Beautiful Bill Act (OBBBA) (also known as the Working Families Tax Cuts legislation), notably, reversing the community engagement requirement “as quickly as possible.” He also supports extending the enhanced premium tax credits (EPTCs) for ACA plans. Senator Wyden reiterated his recently announced support for the “Medicare-for-All” proposal to provide a single-payer, universal health care system, but did not commit to holding a hearing on the topic in the Committee.

The recording of the press conference may be viewed here.

CMS Awards $10 Billion for Rural Health Transformation Program

On November 9, 2026, CMS announced $10 billion in awards to all 50 states for the second year of the Rural Health Transformation Program (RHTP).  In the press release, CMS noted that all 50 states submitted annual reports documenting their progress, which CMS reviewed as part of determining each state’s award. State awards were determined based on a variety of factors, including state progress on implementation of state policies to improve rural health. For initiative-based portions of the funding framework, CMS used an established checkpoint model to assess implementation progress. Checkpoints measure concrete steps in implementation, such as establishing program governance, developing and receiving approval of project plans, launching initiatives, reaching milestones, establishing methods for measuring results, and planning for long-term sustainability. CMS highlighted that the RHTP’s five-year structure gives states the opportunity to build, test, refine, and scale approaches capable of delivering sustainable improvements beyond the life of the program. In total, states have received $20 million through the RHTP and are expected to receive an additional $30 million over the remaining three years of the program. Fiscal year (FY) 2027 awards ranged from $142.3 million for New Jersey to $282.0 million for Texas, with most states receiving between $180 million and $220 million.

The CMS press release and list of RHTP awards by state may be found here. The CMS fact sheet may be found here.

Senate Democrats Urge Delay of Medicaid Community Engagement Requirements

On November 9, 2026, a group of 16 Senate Democrats, led by Senators Raphael Warnock (D-GA) and Ben Ray Luján (D-NM), sent a letter to bipartisan Senate leadership urging them to delay implementation of the Medicaid community engagement requirement passed as a part of H.R. 1 by two years. The Senators note that an estimated three to seven million Americans are estimated to lose their health care coverage as a result of the community engagement requirement and argue that states have not had sufficient time to prepare to implement the new reporting mandates set to take effect on January 1, 2027.

In addition to Senators Warnock and Luján, the letter was signed by Senators Angela Alsobrooks (D-MD), Lisa Blunt Rochester (D-DE), Tim Kaine (D-VA), Brian Schatz (D-HI), Tammy Duckworth (D-IL), Jeanne Shaheen (D-NH), Mark Kelly (D-AZ), Tina Smith (D-MN), Alex Padilla (D-CA), Chris Van Hollen (D-MD), Mazie Hirono (D-HI), Andy Kim (D-NJ), Michael Bennet (D-CO), and Tammy Baldwin (D-WI).

Additionally, on November 9, 2026, Senate Finance Committee Ranking Member Ron Wyden (D-OR) and House Energy and Commerce Committee Ranking Member Frank Pallone (D-NJ-6) sent a joint letter to CMS Administrator Mehmet Oz urging for an immediate delay of the community engagement requirements, highlighting the coverage loss resulting from administrative burden on the enrollees and a lack of implementation time at the state level.

The Senate Democratic letter may be found here. The letter sent by Senator Wyden and Representative Pallone may be found here.

Congressional Republicans Elect New Leadership for 120th Congress

On November 10, 2026, House and Senate Republicans held leadership elections for the next Congress. House Republicans elected Rep. Jim Jordan (R-OH-4) as House Minority Leader, defeating Rep. Steve Scalise (R-LA-1) by a 106-73 vote in a closed-door conference election. Representative Jordan is a co-founder of the House Freedom Caucus and current chair of the House Judiciary Committee. Republicans also reelected Representative Tom Emmer (R-MN-6) as House Minority Whip, defeating a challenge from Representative August Pfluger (R-TX-11). Senate Republicans reelected Senator John Thune (R-SD) as Senate Minority Leader, Senator John Barrasso (R-WY) as Senate Minority Whip, and Senator Shelley Moore Capito (R-WV) as Senate Republican Policy Committee Chair.

Senate and House Democrats are expected to hold leadership elections in the coming weeks. On November 12, 2026, Senator Chris Van Hollen (D-MD) announced that he will be challenging Senator Schumer for Senate Majority Leader. Despite this challenge, Senator Schumer is expected to retain his leadership position, as will Representative Hakeem Jeffries (D-NY-8), who is currently running unopposed.

Senator Rand Paul to Serve as Ranking Member of Senate HELP Committee

On November 11, 2026, Senator Rand Paul (R-KY) announced that he plans to serve as Ranking Member on the Senate HELP Committee in the 120^th Congress, following Democrats flipping the chamber. Current HELP Chair Bill Cassidy (R-LA) is exiting Congress after losing his primary earlier this year, opening the Republican lead to Senator Paul, who is now the most senior member on the Committee. This move will leave a vacancy among Republican leadership on the Senate Homeland Security and Governmental Affairs Committee, where he currently serves as Chair.

Senator Paul is an ophthalmologist by training and has historically been a strong ally of the Make America Healthy Again (MAHA) movement, led by HHS Secretary Robert F. Kennedy, Jr. In a press release, Senator Paul said that he plans to “stand against efforts to put Washington between Americans and their doctors, their children’s schools, and their paychecks.” He is likely to stand in opposition to incoming Chair Bernie Sanders’ (I-VT) Medicare-for-All proposal and Senate Democrats’ expressed priority of repealing or delaying H.R. 1 provisions and reinstating the EPTCs. Senator Paul was also the lone HELP Committee member to vote against the bipartisan S. 2355, Patients Deserve Price Tags Act.

The press release from Senator Paul’s office may be found here.

CMS Extends Medicare Hospice and Home Health Enrollment Moratorium

On November 12, 2026, CMS extended its nationwide moratorium on new Medicare enrollments for hospices and HHAs for an additional six months. CMS noted that the initial moratoria, which began May 13, 2026, allowed CMS to conduct targeted investigations and deploy advanced data analytics to identify hospice and home health providers suspected of committing fraud and remove them from the Medicare program. CMS determined that extending the moratorium for an additional six months was necessary to allow the agency to monitor providers for indicators of fraud, and, when appropriate, take administrative actions such as payment suspension and revocation to combat this conduct.

As with the original moratorium, the extensions apply nationwide, preventing potentially fraudulent operators from circumventing the enrollment restrictions by moving across state lines. The moratorium extensions will continue to cover new applications for initial Medicare enrollment and certain changes in majority ownership. Unlike the May 2026 moratorium, the moratorium extensions will allow currently enrolled hospices and HHAs to add new practice locations within their existing enrollment. The extensions will not affect existing Medicare enrollments or prevent currently enrolled providers from continuing to deliver services. 

The notice, as published in the Federal Register, may be found here (hospice) and here (HHA). The CMS press release may be found here.

Senate Democrats Press CMS on Medicaid Program Integrity and Fraud Enforcement

On November 13, 2026, Senate Finance Committee Ranking Member Ron Wyden (D-OR) alongside five other Senate Democrats sent a letter to CMS Administrator Oz requesting information on the agency’s Medicaid program integrity activities and recent enforcement actions against Democratic-led states. The letter follows the Trump Administration threatening state health programs with significant cuts based on what they label as “flawed” data, CMS withholding Medicaid payments to California and Minnesota, and the HHS OIG decertifying state Medicaid Fraud Control Units (MFCUs) in Hawaii and New York. The letter also raises concerns about the Administration violating federal law by failing to maintain the minimum required funding and staffing levels for the Medicaid Integrity Program (MIP), which was created by Congress to help states fight fraud.

The Senators requested information regarding their concerns, as well as on the funding, staffing, and results of CMS’s Medicaid Fraud “War Room” and artificial intelligence (AI) pilots intended to identify potentially improper Medicaid billing. The letter asked CMS to provide all requested documents and information by November 27, 2026. The Senators also requested a staff-level briefing within two weeks on the operational and fiscal relationship between the MIP, the Medicaid Fraud War Room, and the Healthcare Fraud Prevention Partnership.

The letter sent to CMS Administrator Oz may be found here. The press release from Senator Wyden’s office may be found here.

CMS Offers Hold Harmless Period for Medicaid Community Engagement Requirements

On November 13, 2026, CMS announced an optional hold harmless period for states to delay enforcement of the Medicaid community engagement requirement through June 30, 2027. States that elect to implement the hold harmless period will assess whether individuals either meet the work requirement or are excluded from it, but will not deny applications or disenroll otherwise eligible individuals solely for failure to meet the requirement. CMS notes that this hold harmless transition period will provide states the opportunity to improve and refine their processes, identify and address workforce training needs, and streamline the applicant and beneficiary experience prior to enforcement. In addition to implementing the hold harmless period, CMS also strongly encourages all states to maximize automated verification by utilizing reliable data already available to the state to verify qualifying activities and possible exclusions before prompting applicants to provide additional information; streamline the verification process; test and strengthen all systems and system coordination; and coordinate with community partners to connect applicants and beneficiaries with opportunities for employment, education, job training, and volunteering.

The CMS press release may be found here.

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