Health Care Week in Review | HHS Releases Artificial Intelligence (AI) Strategy; Senate Democrats Announce Plan to Introduce A Clean 3-Year Extension of ACA Enhanced Premium Tax Credits

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 28, 2025, the Centers for Medicare & Medicaid Services (CMS) released a rule entitled, Calendar Year 2026 Home Health Prospective Payment System Rate Update, etc. This final rule sets forth routine updates to the Medicare home health (HH) payment rates in accordance with existing statutory and regulatory requirements. In addition, this final rule finalizes permanent and temporary behavior adjustments and recalibrates the case-mix weights and updates the functional impairment levels; comorbidity subgroups; and low-utilization payment adjustment (LUPA) thresholds for calendar year (CY) 2026. This final rule also finalizes changes to the face-to-face encounter policy and changes to the Home Health Quality Reporting Program (HHQRP) and the expanded Home Health Value-Based Purchasing (HHVBP) Model requirements. In addition, it updates the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). Lastly, it finalizes a technical change to the HH conditions of participation; updates to DMEPOS supplier conditions of payment; updates to provider and supplier enrollment requirements; and changes to DMEPOS accreditation requirements.
• On November 28, 2025, the Food and Drug Administration (FDA) released draft guidance entitled, QE3 Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs. This draft guidance presents a holistic framework and process for the assessment and control of extractables and leachables (E&L) for pharmaceutical products. The draft guidance builds upon International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) impurity guidances on new drug substances (ICH Q3A) and new drug product (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), as well as DNA reactive (mutagenic) impurities (ICH M7). In addition to outlining E&L safety assessment principles, the draft guidance includes draft supporting documentation of Class 3 leachable monographs. The draft guidance is intended to provide approaches to risk-based assessment and control of E&L to ensure patient safety and pharmaceutical product quality.
• On November 28, 2025, FDA released draft guidance entitled, Q3E Guideline for Extractables and Leachables. This draft guidance presents a holistic framework and process for the assessment and control of E&L for pharmaceutical products. The draft guidance builds ICH Q3A and ICH Q3B, ICH Q3C, and ICH Q3D, as well as ICH M7. In addition to outlining E&L safety assessment principles, the draft guidance includes draft supporting documentation of Class 3 leachable monographs. The draft guidance is intended to provide approaches to risk-based assessment and control of E&L to ensure patient safety and pharmaceutical product quality.
• On November 28, 2025, FDA released guidance entitled, Current Good Manufacturing Practice for Medical Gases: Draft Guidance for Industry. This guidance is intended to assist manufacturers of medical gases in complying with regulations for current good manufacturing practice (CGMP) that become effective on December 18, 2025. These regulations are specific to medical gases for human and animal use and, like all CGMP requirements, contain the minimum requirements to ensure that manufacturing processes operate under a state of control to meet prespecified quality standards for identity, strength, quality, and purity, but are tailored more narrowly to how medical gases are manufactured, packaged, labeled, stored, and distributed. This draft guidance is being issued to reflect new and revised regulations in several areas to reduce the regulatory burden, as appropriate, for the medical gas industry. This draft guidance revises and replaces the draft guidance entitled, Current Good Manufacturing Practice for Medical Gases, issued in June 2017.
• On December 1, 2025, the Health Resources and Services Administration (HRSA) released a notice entitled, Medical Student Education Program Non-Competitive Supplement. HRSA provides grants to public institutions of higher education to expand or support graduate education for medical students preparing to become physicians in states with a projected primary care provider shortage. This supplemental funding is for the 12 Medical Student Education (MSE) Program award recipients from the fiscal year (FY) 2023 cohort to expand scholarships and faculty, preceptor, and curriculum development activities.
• On December 2, 2025, FDA released guidance entitled, QTc Information in Human Prescription Drug and Biological Product Labeling. This guidance is intended to assist applicants with incorporating heart rate-corrected QT (QTc) interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological products. The guidance provides recommendations on how and where to appropriately include the clinically relevant information on QTc interval prolongation in the labeling, in accordance with regulatory requirements for the content and format of human prescription drug labeling. This guidance finalizes the draft guidance of the same title issued on August 8, 2023.
• On December 2, 2025, FDA released draft guidance entitled, Monoclonal Antibodies: Streamlined Nonclinical Safety Studies. The draft guidance provides recommendations for streamlined approaches to assess long-term safety from monoclonal antibodies that recognize a single molecular target; describes when general toxicology studies are not warranted or may be limited to a short-term study; and addresses reproductive, developmental, and juvenile toxicity assessments. The draft guidance is intended to assist sponsors in avoiding unnecessary use of animals, particularly non-human primates (NHPs), in furtherance of FDA’s “3R” principles of reducing, refining, and replacing the use of animal testing.
• On December 2, 2025, CMS released a notice entitled, Medicare, Medicaid, and Children's Health Insurance Programs: Provider Enrollment Application Fee Amount for Calendar Year 2026. This notice announces a $750.00 CY 2026 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2026, and on or before December 31, 2026.
• On December 2, 2025, CMS released a rule entitled, Medicare and Medicaid Programs: Repeal of Minimum Staffing Standards for Long-Term Care Facilities. This interim final rule repeals provisions of the final rule entitled, Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting. CMS took this action in view of changes made by public law, which precludes HHS from implementing, administering, or enforcing certain provisions of the final rule until September 30, 2034.
• On December 3, 2025, FDA released a rule entitled, Medical Devices: Quality Management System Regulation Technical Amendments. FDA is amending certain medical device regulations to revise references and language in existing Code of Federal Regulations (CFR) provisions to conform with the final rule entitled, Medical Devices; Quality System Regulation Amendments. This rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors, conform regulatory references, and ensure accuracy and clarity in the FDA’s regulations.
• On December 3, 2025, FDA released guidance entitled, eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff. This guidance provides information on the eCopy Program for medical device submissions. Section 745A(b)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by section 207 of the FDA Reauthorization Act of 2017 (FDARA), requires that Pre-Submissions and submissions for devices under section 510(k), 513(f)(2)(A), 515(c), 515(d), 515(f), 520(g), 520(m), or 564 of the FD&C Act or section 351 of the Public Health Service Act, and any supplements to such Pre-Submissions or submissions, including appeals of those submissions, be submitted in solely in electronic format, beginning on such date as specified by FDA in final guidance. The eSTAR Program is the current program for submissions solely in electronic format. Until such time that eSTAR is implemented for each specified submission type, Section 745A(b)(1) identifies that Pre-Submissions or submissions for the submission types identified above must be submitted as electronic copies (eCopies). This guidance describes how FDA is implementing the eCopy Program under section 745A(b) of the FD&C Act.
• On December 3, 2025, CMS released a notice entitled, Medicare Program: Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2026. This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2026. The CY 2026 AIC threshold amounts are $200 for ALJ hearings and $1,960 for judicial review.
• On December 3, 2025, the Centers for Disease Control and Prevention (CDC) released a rule update entitled, Control of Communicable Diseases; Foreign Quarantine; Expiration. CDC is announcing that interim final rule (IFR) 0920- AA75, which amended its Foreign Quarantine regulations during the COVID-19 public health emergency, has expired.
• On December 4, 2025, FDA released guidance entitled, Product-Specific Guidances. These product-specific draft guidances provide recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled, Bioequivalence Recommendations for Specific Products, that explained the process that would be used to make product-specific guidances available to the public on FDA’s website. The draft guidances identified in this notice were developed using the process described in that guidance.
• On December 4, 2025, the Department of Health and Human Services (HHS) released a notice entitled, Medicare and Medicaid Programs: Continued Approval of the American Association for Accreditation of Ambulatory Surgery Facilities’ Rural Health Clinic Accreditation Program. This notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities (DBA “QUAD A”) for continued recognition as a national accrediting organization (AO) for rural health clinics that wish to participate in the Medicare or Medicaid programs. The statute requires that, within 60 days of receipt of an organization’s complete application, the HHS Secretary publishes a notice through CMS that identifies the AO making the request, describes the nature of the request, and provides at least a 30-day public comment period.
• On December 4, 2025, CMS released a notice entitled, Medicare and Medicaid Programs: Announcement of Application from a Hospital Requesting Waiver for Organ Procurement Service Area. This notice acknowledges the receipt of an application from a hospital that has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated organ procurement organization (OPO). This notice requests comments from OPOs and the general public for CMS’s consideration in determining whether CMS should grant the requested waiver.
• On December 4, 2025, FDA released a notice entitled, Emergency Use of a Drug Product During the COVID-19 Pandemic; Revocation. FDA announced the revocation of the Emergency Use Authorization (EUA) issued to Genentech, Inc. for Actemra (tocilizumab). FDA revoked this EUA on August 8, 2025, under the FD&C Act. The revocation, including an explanation of the reasons for the revocation, are reprinted in this document.
• On December 4, 2025, FDA released a notice entitled, Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot. FDA’s Center for Devices and Radiological Health (CDRH) is announcing its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot (“TEMPO pilot”), in connection with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, to promote access to certain digital health devices while safeguarding patient safety.

Event Notices

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

• December 9, 2025: The National Institutes of Health (NIH) announced a meeting of the Council of Councils. This is a hybrid meeting open to the public.
• December 9, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• December 10, 2025: CMS announced a town hall meeting on FY 2027 applications for new technology add-on payments. This is a virtual meeting open to the public.
• December 10, 2025: FDA announced a workshop entitled, Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks. This is a hybrid meeting open to the public.
• December 10, 2025: FDA announced a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• December 10, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a virtual meeting open to the public.
• December 15-18, 2025: HRSA announced a public meeting of the Advisory Commission on Childhood Vaccines. This is a virtual meeting open to the public.
• December 16, 2025: FDA announced a public workshop entitled, Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine. This is a virtual workshop open to the public.
• December 17-18, 2025: CMS announced the second biannual virtual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2025. This is a virtual meeting open to the public.
• December 18, 2025: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a hybrid meeting open to the public.
• **January 12-14, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a virtual meeting with some sessions open to the public.
• January 22, 2026: FDA announced a meeting of the Tobacco Products Scientific Advisory Committee. This is a hybrid meeting open to the public.
• January 23, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a virtual meeting open to the public.
• **January 26, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a virtual meeting with some sessions open to the public.
• January 28-29, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.
• **February 8-10, 2026: NIH announced a meeting of the National Institute of Environmental Sciences. This is a hybrid meeting with some sessions open to the public.
• February 9-10, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• March 30-31, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• May 4, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• May 13, 2026: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
• June 1-2, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• June 5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 15-16, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

• On December 3, 2025, GAO released a report entitled, Patient Protection and Affordable Care Act: Preliminary Results from Ongoing Review Suggest Fraud Risks in the Advance Premium Tax Credit Persist. GAO found that fraud risks in the advanced premium tax credit (APTC) program persist, based on preliminary results from ongoing covert testing and data analysis. GAO’s analysis revealed vulnerabilities in Marketplace data, including potential misuse of Social Security numbers (SSNs) and unauthorized enrollment changes. For plan year 2023, GAO could not identify evidence of reconciliation for over $21 billion in APTCs, which may include overpayments to ineligible enrollees. Additionally, GAO found over 29,000 SSNs in 2023 and nearly 68,000 in 2024 used for multiple enrollments in a single year, and at least 160,000 applications in 2024 with likely unauthorized changes by agents or brokers. CMS implemented a new control in July 2024 to address unauthorized changes, which GAO is reviewing. GAO also identified weaknesses in CMS’s fraud risk management. CMS has not updated its fraud risk assessment since 2018, and the existing assessment does not fully align with leading practices or inform an antifraud strategy.
• On December 3, 2025, the Government Accountability Office (GAO) released a report entitled, VA Health Care: Status of Key Recommendations Related to Mental Health and Medication Management. GAO reviewed the Department of Veterans Affairs’ (VA) efforts to manage medications for veterans, particularly those with mental health conditions and chronic pain. GAO found that VA implemented four recommendations to improve oversight of mental health treatment plans and opioid risk mitigation strategies. For mental health care, VA now requires providers to document evidence-based treatment options and conducts biannual chart reviews. For opioid safety, VA expanded its Opioid Safety Initiative by creating tools and training to ensure providers follow risk mitigation practices, such as urine drug screenings. However, VA has not yet implemented GAO’s recommendation for the Department of Defense-VA Joint Executive Committee to assess the effectiveness of mental health services for transitioning service members. While the Department of Defense-VA Joint Executive Committee identified mental health touchpoints, it has not evaluated whether these efforts improve access. GAO conducted this work due to concerns about polypharmacy and its risks, including increased suicide risk when opioids and benzodiazepines are prescribed together.
• On December 4, 2025, the HHS Office of Inspector General (OIG) released a report entitled, Medicare Improperly Paid Selected Optometrists for Services Provided to Enrollees at Nursing Facilities. OIG audited Medicare Part B payments to optometrists for high-level evaluation and management (E/M) services typically not billed by optometrists. Between 2021 and 2023, Medicare paid $4.7 million to 200 optometrists for moderate to highly complex subsequent nursing facility care, with the top 15 optometrists accounting for 72 percent of these payments. The audit focused on whether these 15 optometrists complied with Medicare billing requirements. OIG found that none of the sampled claims met Medicare documentation or coding requirements. All 399 claim lines billed as high-level E/M codes were noncompliant, and OIG estimated at least $3 million in overpayments during the audit period. CMS had not conducted claim reviews for optometrists’ billing and lacked system edits to prevent incorrect coding. OIG recommended that CMS recover overpayments within the 4-year reopening period, increase claim reviews, and implement system edits to prevent improper billing. CMS concurred with two recommendations but did not fully agree to expand claim reviews or develop system edits.

Hearings & Markups

• On December 2, 2025, the House Ways and Means Oversight Subcommittee held a hearing entitled, Lives at Stake: Holding Tax-Exempt Organ Procurement Organizations Accountable. Witnesses included: Ms. Heather Knuckles, Family Member of Organ Donor; Ms. Nyckolleta (Nycki) Martin, Whistleblower, Former OPO Employee; Ms. Jennifer Erickson, Senior Fellow for Organ Donation Policy, Federation of American Scientists; and Dr. Emily Gee, Senior Vice President, Economic Policy; Senior Fellow, Health Policy, American Progress.
• On December 3, 2025, the Senate Committee on Health, Education, Labor & Pensions (HELP) held a hearing entitled, Making Health Care Affordable Again: Healing a Broken System. Witnesses included: Mr. Joel White, President, Council for Affordable Health Coverage; Ms. Marcie Strouse, Owner and Partner, Capitol Benefits Group; and Dr. Claudia M. Fegan, MD, National Coordinator, Physicians for a National Health Program.
• On December 3, 2025, the Senate Special Committee on Aging held a hearing entitled, Aging in Place: The Impact of Community during the Holidays. Witnesses included: Mr. John Offerdahl, President, Offerdahl’s Hand-Off Foundation; Mr. Jason Resendez, CEO, National Alliance for Caregiving; Ms. Alison Barkoff, JD, Hirsh Health Law & Policy Associate Professor and Director of the Hirsh Health Law & Policy Program, George Washington University; and Ms. Emily Ladau, Disability Right Advocate and Author of Demystifying Disability.
• On December 3, 2025, the House Committee on Veterans' Affairs held a hearing entitled, Legislative Hearing on H.R: 6047, the “Sharri Briley and Eric Edmundson Veterans Benefits Expansion Act of 2025”, H.R. 4077, the “GUARD Veterans’ Health Care Act.”   Witnesses included: Mrs. Sharri Briley, Surviving Spouse of CWR Donovan ‘Bull’ Briley; Mr. Edgar Edmundson, Father of Sargeant Eric Edumndson; Ms. Kristina Keenan, Legislative Director, Veterans of Foreign Wars; Dr. Brian Miller, Associate Professor of Medicine, Johns Hopkins University; Mr. Tom Wheaton, National Treasurer, Paralyzed Veterans of America; Ms. Margarita Devlin, Principal Deputy Undersecretary for Benefits, Performing the Delegable Duties of the Undersecretary for Benefits, VA; Ms. Heather Ford, Acting Chief Financial Officer, Veterans Health Administration, VA; Mr. Kevin Johnson, Director, Revenue Operations, and Office of Finance, Veterans Health Administration, VA; and Ms. Stephanie Li, Assistant Director, Regulations, Legislation, Engagement, and Training, Veterans Benefits Administration, VA.

Other Health Policy News

• On December 1, 2025, CMS announced the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model. This voluntary, 10-year model starting July 1, 2026, is intended to test whether recurring “Outcome-Aligned Payments” for managing patients’ qualifying condition(s) result in clinical improvement or control of the condition(s). Through the ACCESS Model, CMS intends to expand clinicians’ ability to offer technology-supported care to improve patients’ health while complementing traditional care.
  

  Initially, the ACCESS Model will focus on the following four clinical tracks and include chronic conditions:

  • Early cardio-kidney-metabolic conditions (eCKM): hypertension (high blood pressure), dyslipidemia (high or abnormal lipids, including cholesterol), obesity or overweight with marker of central obesity, and prediabetes
  • Cardio-kidney-metabolic conditions (CKM): diabetes, chronic kidney disease (3a or 3b), and atherosclerotic cardiovascular disease, including heart disease
  • Musculoskeletal conditions (MSK): chronic musculoskeletal pain
  • Behavioral health conditions (BH): depression and anxiety

  More information, including the Request for Applications, is forthcoming. Applications will be due by April 1, 2026. The model webpage can be accessed here. The model interest form can be found here.

• On December 3, 2025, the Senate HELP Committee held a hearing entitled, Making Health Care Affordable Again: Healing a Broken System. This hearing focused on the challenge of health care affordability, particularly the looming expiration of ACA enhanced premium tax credits (EPTCs) on January 1, 2026. Some Members urged extending EPTCs to prevent premium increases and coverage losses. Committee Ranking Member Bernie Sanders (I-VT) pushed for a clean extension of the tax credits for at least one to three years to prevent millions from losing coverage or facing unaffordable premiums. Other Members argued that the current subsidy structure masks true costs and enables fraud, instead proposing alternatives such as pre-funded Health Savings Accounts (HSAs), greater price transparency, and increased competition to address the root causes of rising costs and improve patient choice. Of note, Committee Chairman Bill Cassidy (R-LA) proposed redirecting EPTC funds from insurers to pre-funded HSAs paired with bronze plans, contending that this approach would send 100 percent of dollars directly to patients rather than being diminished by administrative overhead and profit. Witnesses examined the drivers of rising health care costs, with some advocating for market-based solutions and others calling for systemic reforms such as Medicare for All.
  
  More information on this hearing can be found here.
• On December 4, 2025, Senate Democrats officially announced that they will attempt to advance a three-year extension of the ACA EPTCs, with a vote on the legislation scheduled for next Thursday, December 11, 2025. Additionally, House Speaker Mike Johnson (R-LA) announced that House Republican leadership will likely roll out their health care plan this weekend or early next week, which is not currently slated to include an extension of the EPTCs. The Democratic bill is expected to fail without support from Republicans.
• On December 4, 2025, HHS released its AI Strategy for integrating AI tools into its internal operations and research. The AI Strategy focuses on five essential pillars: (1) ensure governance and risk management for public trust, (2) design infrastructure and platforms for user needs, (3) promote workforce development and burden reduction for efficiency, (4) foster health research and reproducibility through gold standard science, and (5) enable care and public health delivery modernization for better outcomes.
  
  Goals based on these pillars range from establishing pre-deployment protocols for technology adoption; acquiring private sector AI tools for use in HHS research; and supporting early decision-making, risk stratification, and proactive outreach in HHS work. In a press release, HHS states that this AI Strategy is not a comprehensive vision for how HHS will integrate AI, but does outline HHS’s first steps in doing so.
  
  The full AI Strategy can be found here. A press release can be found here.

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