Health Care Week in Review July 2, 2026

Health Care Week in Review | CMS Releases OPPS and Home Health Proposed Payment Rules; House Ways and Means Committee Advances Tax-Exempt Hospital Transparency Bill

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. 

Highlight of the Week

This week, CMS released CY 2027 proposed rules for the Home Health and Hospital Outpatient Prospective Payment Systems that would revise payment rates, quality reporting, provider enrollment, and fraud prevention policies, while the House Ways and Means Committee advanced a bill to establish new reporting requirements for tax-exempt hospitals.

Regulations, Notices & Guidance

  • On June 29, 2026, the Food and Drug Administration (FDA) released a rule entitled, Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation. FDA is classifying the monitor for opioid induced impairment of oxygenation into class II (special controls). The special controls that apply to the device type are identified in this rule and will be part of the codified language for classification of the monitor for opioid induced impairment of oxygenation. FDA is taking this action because the agency has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
  • On June 29, 2026, FDA released a rule entitled, General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis. FDA is classifying the skin patch for treatment of hyperhidrosis into class II. The special controls that apply to the device type are identified in this rule and will be part of the codified language for classification of the skin patch for treatment of hyperhidrosis. FDA is taking this action because the agency has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
  • On June 30, 2026, the Health Resources and Services Administration (HRSA) released a notice entitled, Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas. This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSA) in a designated status as of April 30, 2026. HRSA also announced that HPSAs that were placed in a proposed for withdrawal status due to state primary care office (PCO) actions between October 16, 2024, and September 21, 2025, will be withdrawn. HPSAs that did not pass the National Shortage Designation Update conducted in September 2025 will be maintained in a proposed for withdrawal status after the publication of this notice, and the state PCOs will be allowed additional time to review and update designations. HRSA intends to address those HPSAs with the publication of the federal register notice (FRN) on or before July 1, 2027.
  • On June 30, 2026, HRSA released a notice entitled, Modification of Living Organ Donation Reimbursement Program Eligibility Guidelines in Response to Honor Our Living Donors Act. HRSA proposes to modify the eligibility guidelines for the Living Organ Donation Reimbursement Program (LODRP) to align with the Honor Our Living Donors Act (HOLD Act), enacted on February 3, 2026. The HOLD Act prohibits consideration of the income of the organ transplant recipient in determining eligibility for reimbursement of qualifying non-medical expenses related to living organ donation under LODRP. Consistent with this statutory requirement, HRSA is proposing to revise the LODRP eligibility guidelines to eliminate recipient income as a factor in eligibility determinations and to establish a donor-focused eligibility framework based on donor household income and financial need. HRSA will continually monitor the effectiveness and availability of funds for LODRP and further modify the eligibility guidelines in the future if needed.
  • On June 30, 2026, the National Institutes of Health (NIH) released a notice entitled, Federal Demonstration Partnership; Phase VIII. NIH solicits large and small public and private colleges and universities, non-profit research and education organizations, and research hospitals and medical centers that are recipients of federal research or research-related funding to participate in Phase VIII of the Federal Demonstration Partnership (FDP). FDP is a forum of federal agencies and recipients committed to testing innovative approaches and streamlining processes and systems for federally supported research. It is anticipated that the National Academy of Sciences, Engineering and Medicine will continue to function as the secretariat for the FDP, as it has since 1988.
  • On July 1, 2026, the Administration for Children and Families (ACF) released a rule entitled, Reducing Bureaucracy and Burden for Children, Youth, and Family Programs. This final rule removes duplicative and unnecessary sections from the Runaway and Homeless Youth Program regulations. These amendments will streamline the Runaway and Homeless Youth Program regulations to make them more accessible to the public.
  • On July 1, 2026, the Drug Enforcement Administration (DEA) released a proposed rule entitled, Temporary Placement of 7-Hydroxymitragynine above a Specified Threshold in Schedule I. This proposed rule would place a temporary order to schedule 7-hydroxymitragynine above a specified threshold, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 7-hydroxymitragynine above a specified threshold.
  • On July 1, 2026, DEA released a proposed rule entitled, Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I. This proposed rule would place a temporary order to schedule three 7-hydroxymitragynine-related substances (mitragynine pseudoindoxyl, MGM-15, and MGM-16), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle these three 7-hydroxymitragynine-related substances.
  • On July 1, 2026, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule entitled, Calendar Year 2027 Home Health Prospective Payment System Rate Update; etc. This proposed rule would set forth annual updates to the Medicare home health payment rates for calendar year (CY) 2027 in accordance with existing statutory and regulatory requirements.
  • On July 2, 2026, CMS released a proposed rule entitled, Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; etc. This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System for CY 2027.

Event Notices

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

  • July 6-7, 2026: NIH announced a meeting of the National Cancer Institute (NCI). This is a virtual meeting with some sessions open to the public.
  • July 7, 2026: FDA announced an educational conference entitled, Third Annual Animal Drug User Fee Educational Conference. This is a hybrid event open to the public.
  • July 8, 2026: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a hybrid meeting with some sessions open to the public.
  • July 14-15, 2026: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting open to the public.
  • July 15, 2026: NIH announced a meeting of the NCI Clinical Trials and Translational Research Advisory Committee. This is a virtual meeting open to the public.
  • July 16, 2026: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
  • July 23-24, 2026: FDA announced a meeting of the Pharmacy Compounding Advisory Committee. This is a hybrid meeting open to the public.
  • July 29, 2026: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This is a virtual meeting open to the public.
  • August 2-4, 2026: NIH announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health Sciences. This is a virtual meeting with some sessions open to the public.
  • August 6, 2026: NIH announced a meeting of the National Heart, Lung, and Blood Institute. This is a hybrid meeting open to the public.
  • August 25, 2026: FDA announced a meeting entitled, Patient-Focused Drug Development for Nonhealing Chronic Wounds. This is a hybrid meeting open to the public.
  • September 2, 2026: NIH announced a meeting of NCI. This is a virtual 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 14-15, 2026: The Department of Health and Human Services (HHS) announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
  • September 16, 2026: NIH announced a meeting of the National Institute of Biomedical Imaging and Bioengineering. This is an in-person meeting with some sessions open to the public.
  • September 15-16, 2026: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a virtual meeting 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.
  • September 24, 2026: The Office of the National Coordinator for Health IT (ONC) announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
  • October 14, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) National Advisory Child Health and Human Development Council. This is an in-person meeting with some sessions open to the public.
  • October 16, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
  • **October 20, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a virtual meeting open to the public.
  • November 5, 2026: ONC announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
  • December 1, 2026: NIH announced a meeting of NCI. This is an in-person meeting with some sessions open to the public.
  • December 7-8, 2026: NIH announced a meeting of NICHD. This is a hybrid meeting open to the public.
  • December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
  • January 16, 2027: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. This is a virtual meeting open to the public.

Reports, Studies & Analyses

  • On June 29, 2026, the Government Accountability Office (GAO) released a report entitled, National Alzheimer’s Project: HHS Needs to Better Assess and Communicate Progress. GAO found that the National Alzheimer’s Project has played a significant role in advancing federal coordination of Alzheimer’s disease and related dementia research, with stakeholders citing major accomplishments, including the development of new blood-based diagnostic tools, treatments designed to slow progression of early-stage Alzheimer’s disease, expanded understanding of dementia risk factors, and increased support for patients and caregivers through. Despite these achievements, GAO found that HHS has not adequately assessed or communicated the National Alzheimer’s Project’s overall progress toward its long-term goals. While HHS reports aggregate information showing that many Advisory Council recommendations have been fully or partially implemented, it does not regularly provide detailed information on the status of individual recommendations. GAO also concluded that HHS has not adopted key performance management practices at the project level. GAO found that HHS lacks a comprehensive framework to evaluate progress, make informed management decisions, and clearly communicate outcomes to stakeholders. GAO recommended that HHS provide more detailed implementation updates on Advisory Council recommendations, establish project-level performance goals and measures, collect and use data to assess progress, and present project results in a clearer and more accessible format.
  • On June 29, 2026, the HHS Office of Inspector General (OIG) released a report entitled, Part D Plans Generally Include Drugs Commonly Used by Dual-Eligible Enrollees: 2026. OIG found that Medicare Part D plans generally continue to provide broad formulary coverage for prescription medications most commonly used by individuals dually eligible for Medicare and Medicaid. Examining 327 unique formularies used by more than 5,000 Part D plans in 2026, OIG found that most formularies covered nearly all commonly used drugs, with 315 formularies covering at least 97 percent of the 192 frequently utilized medications included in the analysis. Among benchmark plans—those to which dual-eligible beneficiaries are often automatically assigned—most formularies also covered at least 97 percent of commonly used drugs. Although two commonly prescribed drugs, one for diabetes and one for gastroesophageal reflux disease, were covered by fewer than 75 percent of formularies, plans generally included alternative drugs within the same therapeutic classes. OIG concluded that dual-eligible beneficiaries can generally expect access to the vast majority of commonly used prescription drugs regardless of their Part D plan, although beneficiaries whose medications are not on a formulary may need to navigate plan changes, appeals processes, alternative therapies, or out-of-pocket costs to obtain coverage. The findings are consistent with OIG’s annual assessments since 2011, indicating that overall access to commonly used medications for dual-eligible beneficiaries has remained stable.
  • On July 2, 2026, GAO released a report entitled, Assisted Living Facilities: Information on Federal Spending and Medicaid Coverage. GAO examined federal spending and Medicaid coverage related to services provided in assisted living facilities and found that federal Medicaid and Medicare spending for such services totaled at least $12 billion in 2024, although the amount is likely underestimated due to data limitations and inconsistent identification of assisted living facilities across states. GAO identified at least $3.5 billion in federal Medicaid spending and $8.5 billion in traditional Medicare spending associated with services delivered in assisted living settings. Medicaid spending primarily supported assisted living services and other health care services for approximately 300,000 beneficiaries, while Medicare spending was largely attributable to hospice and home health services provided to roughly 829,000 beneficiaries. The report also found that 44 states covered assisted living services for older adults and people with disabilities through Medicaid as of March 2025. However, coverage policies, eligibility standards, payment rates, and service offerings varied substantially across states. Stakeholders cited several factors affecting access, including the inability of Medicaid to cover room and board costs, enrollment caps and other coverage limitations within Medicaid programs, low provider participation driven by reimbursement concerns, workforce shortages, and growing demand associated with an aging population. While some states have implemented strategies to improve access, stakeholders expressed concerns that affordability challenges and fiscal pressures on Medicaid programs could continue to constrain access in the future.

Hearings & Markups

  • On June 29, 2026, the House Committee on Rules met on the following measures: H.R. 8800 – National Defense Authorization Act for Fiscal Year 2027; H.R. 8884 – Removing Barriers to Work for Disabled Americans Act; and H. Res. 1383 – Commemorating the one-year anniversary of the enactment of the Working Families Tax Cuts Act.
  • On June 30, 2026, the House Committee on Appropriations Subcommittee on Financial Services and General Government held a hearing entitled, Oversight Hearing - Office of Management and Budget. The Honorable Russell Vought, Director, Office of Management and Budget (OMB) served as the sole witness.
  • On June 30 2026, the House Committee on Veterans’ Affairs Subcommittee on Health held a legislative hearing on H.R.4398, the Veteran Burial Timeliness and Death Certificate Accountability Act; H.R.4805, the Warrior Impact from Neurological and G-Force Stress Act; H.R.6835, the Veterans Spinal Trauma Access to New Devices Act; H.R.9376, the Trauma Outreach, Understanding, and Resiliency through Spirituality Act; H.R.9316, the Travel Assistance for Veterans in Medical Deserts Act; Discussion Draft: the Foreign Medical Program Integrity and Improvement Act; Discussion Draft: To direct the Secretary of Veterans Affairs to seek to enter into a memorandum of understanding with the Secretary of Health and Human Services to avoid duplicative, improper, or erroneous billings or payments for hospital care and medical services furnished under the laws administered by the Secretary of Veterans Affairs; Discussion Draft: To direct the Secretary of Veterans Affairs to coordinate with the Secretary of Health and Human Services in administering the Veterans Community Care Program, and for other purposes; Discussion Draft: To direct the Secretary of Veterans Affairs to seek to enter into a memorandum of understanding with the Secretary of Health and Human Services and to provide for coordination between the Secretaries in the administration of the Veterans Community Care Program and certain health plans under the Medicare program, and for other purposes; Discussion Draft: VA Coaching into Care Act; Discussion Draft: National Task Force on Caregiving Youth of Veterans Act; Discussion Draft: the VHA OPEN Policies Act of 2026; Discussion Draft: To direct the Secretary of Veterans Affairs to report biennially on staffing of medical facilities of the Department of Veterans Affairs; H.R.9018: Fostering TRUST Act of 2026; Discussion Draft: the Veterans Health Administration Personnel Transparency and Accountability Act.
  • On July 1, 2026, the House Committee on Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, Direct Contracting: A Prescription for Lower Health Care Costs. Witnesses present included: Dr. Chad Savage, President, Direct Primary Care (DPC) Action, Founder and Physician, YourChoice Direct Care; Mr. Mark Newman, Chief Executive Officer (CEO) and Co-Founder, Nomi Health; Mr. Brad Woodhouse, President, Protect Our Care; and Mr. James Gelfand, President and CEO, The ERISA Industry Committee (ERIC).
  • On July 1, 2026, the House Committee on Ways and Means held a markup of the following legislation: H.R. 9496, the End Tax Penalties on American Hostages Act; H.R. 9500, the Tax Relief for Fraud Victims Act;H.R. 9498, the Taxpayer Advocate Participation Act; H.R. 9501, the AI Tax Integrity Act of 2026; H.R. 9499, the Protecting Taxpayers from Ghost Preparers Act; H.R. 7972, the Taxpayer Workforce Modernization Act; and H.R. 9504, the Tax Exempt Hospital Transparency Act.

Other Health Policy News

  • On July 1, 2026, the House Committee on Ways and Means advanced the Tax-Exempt Hospital Transparency Act (H.R. 9504) to the house floor along party lines. The legislation would expand Internal Revenue Service (IRS) reporting requirements for nonprofit hospitals by requiring additional disclosures related to community benefit spending, subsidized service lines, financial assistance programs, and utilization of the 340B Drug Pricing Program. Larger nonprofit hospital systems would face additional reporting obligations aimed at increasing transparency surrounding the use of their tax-exempt status. Democratic committee members raised concerns that the proposal emphasizes compliance reporting rather than addressing health care affordability, while Republican supporters argued the bill would improve public accountability for tax-exempt hospitals.

    More information on this markup is available here. The full text of H.R. 9504 is available here.

  • On July 1, 2026, Rep. Lloyd Doggett (D-TX), joined by more than 40 House Democrats, introduced the Saving Medicare Enrollees from Deceptive Insurers and Creating Ample Resources for Everyone Act (Saving MEDICARE Act), legislation designed to reduce Medicare Advantage (MA) overpayments and strengthen oversight of the program. The bill would implement several recommendations previously advanced by the Medicare Payment Advisory Commission (MedPAC) and other policy organizations, including limiting the use of diagnosis codes obtained through chart reviews for risk adjustment, eliminating MA quality bonus payments, reforming benchmark payment calculations, strengthening risk adjustment data validation audits, and allowing state insurance commissioners to share enforcement responsibilities with CMS.

    The bill text is available here. A fact sheet is available here. A press release is available here.

  • On July 1, 2026, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule entitled, Calendar Year 2027 Home Health Prospective Payment System Rate Update; etc. This proposed rule would set forth annual updates to the Medicare home health payment rates for CY 2027 in accordance with existing statutory and regulatory requirements. To combat fraud, CMS proposes several provisions modifying Medicare provider and supplier enrollment requirements. In addition, this proposed rule analyzes the difference between assumed and actual behavior change on estimated aggregate expenditures for home health payments and proposes a temporary behavior adjustment to the CY 2027 30-day base payment rate. CMS also proposes to recalibrate the Patient-Driven Groupings Model (PGDM) case-mix weights; update the fixed dollar loss (FDL) for outlier payments; and update functional impairment levels; comorbidity adjustment subgroups; and low-utilization payment adjustment (LUPA) thresholds for CY 2027.

    Additionally, this proposed rule discusses the role of home health in the provision of palliative care services and includes a request for information (RFI) on development of a home health-specific wage index. This proposed rule also proposes various initiatives to improve alignment between the Home Health Quality Reporting Program (HH QRP) and the expanded Home Health Value Based Purchasing (HHVBP) Model. Lastly, the proposed rule would clarify that an additional face-to-face encounter is not necessary under the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) requirements for replacement DMEPOS items; and amend the definition of durable medical equipment (DME) to expand the DME benefit to cover infusion pumps and drugs.

    The proposed rule is available here. A fact sheet is available here. A press release is available here.

  • On July 2, 2026, CMS released a proposed rule entitled, Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; etc. This proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System for CY 2027. CMS proposes updating OPPS payment rates for hospitals and ASC payment rates for ASCs that meet applicable quality reporting requirements by 2.4 percent. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program and the Ambulatory Surgical Center Quality Reporting Program. There would be no changes to the Rural Emergency Hospital Quality Reporting Program.

    Specifically, CMS proposes to expand the method to control unnecessary increases in the volume of outpatient services to include imaging without contrast services furnished in excepted off-campus provider-based departments (PBDs) for CY 2027 by applying a Physician Fee Schedule equivalent payment rate for those services. CMS is also proposing to reduce payments for 340B-acquired drugs; adjust payments for non-drug items and services; maintaining its proposal to eliminate the inpatient only (IPO) list; add a cost-of-living adjustment for payments to hospitals located in Alaska and Hawaii; update payment rates for Intensive Outpatient Program (IOP) and Partial Hospitalization Program (PHP) services furnished in hospital outpatient departments and Community Mental Health Centers (CMHCs); and require prior authorization for eight additional Botulinum Toxin Injection service codes.

    CMS further proposes to make changes to certain measures in the Hospital Outpatient Quality Reporting (OQR) Program and ASC Quality Reporting Program. Additionally, the proposed rule announces notices of closure of teaching hospitals and opportunities to apply for available slots. CMS is further proposing to permit hospital accrediting organizations (AOs) with deeming authority to assess compliance with certain Emergency Medical Treatment and Labor Act (EMTALA) administrative requirements during accreditation and reaccreditation surveys. The proposed rule requests information regarding potential approaches to improve comparability and standardization, particularly for complex contracting methodologies, of the hospital price transparency (HPT) information reported in machine-readable files and consumer-friendly displays. CMS also solicits comments on a potential separate payment under the Inpatient Prospective Payment System (IPPS) for domestic procurement of personal protective equipment and essential medicines.

    The proposed rule is available here. A fact sheet is available here. A press release is available here.

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