This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules; Supreme Court overturns Chevron Doctrine and dismisses Idaho EMTALA case.

House of Representatives

The House of Representatives is in district work period.

Senate

The Senate is in state work period.

House of Representatives

House Appropriations Subcommittee Acts on Labor-HHS FY2025 Bill

On June 27, the House Appropriations Committee Labor, Health and Human Services (HHS), Education and Related Agencies Subcommittee marked up and reported out of committee the FY 2025 Labor-HHS-Ed appropriations bill. The bill would:

  • Fund HHS at $107 billion, $8.5 billion less than in FY 2024 ;
  • Cut Centers for Disease Control and Prevention funding by 22 percent and eliminate 23 programs;
  • Maintain funding for the National Institutes of Health (NIH) at $48 billion and eliminate 12 NIH centers;
  • Decrease Title X family planning grants and prevent federal funds from being used for abortion;
  • Increase funding for the National Cancer Institute to $7.875 billion;
  • Fund the Administration for Strategic Preparedness and Response at $3 billion;
  • Maintain funding for the HHS Office for Civil Rights at $40 million;
  • Increase funding for Substance Abuse and Mental Health Services Administration’s substance use prevention block grants; and
  • Allocate $400 million to prevent rural hospital closures and increase rural residency programs.

For more information, click here.

House Ways and Means Committee Marks Up Four Healthcare Bills

On June 27, the House Ways and Means Committee marked up and reported out of committee four healthcare bills concerning multi-cancer early detection screening, breakthrough medical devices, anti-obesity drugs and a Medicare cognitive impairment detection benefit. One of the bills would allow Medicare to cover the cost of anti-obesity medications.

The bills are:

H.R. 1691, Ensuring Patients Access to Critical Breakthrough Products Act of 2023: Provides a specific pathway for immediate transitional Medicare coverage of breakthrough medical devices for four years once the device has been approved by the Food and Drug Administration (FDA).

H.R. 2407, Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act: Expands access to transitional Medicare coverage and reimbursement for FDA-approved multi-cancer early detection screening tests.

H.R. 8816, American Medical Innovation and Investment Act: Would update coverage evidence development requirements and includes provisions related to innovation.

H.R. 4818, Treat and Reduce Obesity Act of 2023: Allows Medicare to cover anti-obesity medications for new Medicare beneficiaries who already had a non-Medicare plan covering the medicine at least one year before enrolling in the federal health program.

For more information, click here.

House Ways and Means Committee Subcommittee on Health Holds Hearing on Value-Based Care

On June 26, the House Ways and Means Committee Subcommittee on Health held a hearing concerning value-based care. Members discussed how to define and measure high quality care services, increase Medicare Physician Fee Schedule payments and address rural healthcare provider challenges. Witnesses were:

  • Sarah Chouinard, Main Street Health, Chief Medical Officer
  • Stephen Nuckolls, Coastal Carolina Health Care and PA, Chief Executive Officer
  • Matthew Philip, Duly Health and Care, Chief Medical Officer
  • Robert Berenson, Urban Institute Fellow

For more information, click here.

House Energy and Commerce Committee Chairmen Send Letter Concerning FDA Foreign Drug Inspections

On June 21, House Energy and Commerce Committee Chairman Cathy McMorris Rodgers (R-WA) and two subcommittee chairmen, Brett Guthrie (R-KY) and Morgan Griffith (R-VA), sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf, concerning the FDA Foreign Drug Inspection Program.

A committee analysis of FDA inspections demonstrated variations in inspection outcomes. The chairmen are requesting the FDA submit records and documents concerning inspector:

  • Anti-bribery and gratuity training materials;
  • Performance evaluation metrics;
  • Selection process; and
  • Background checks and periodic personnel reviews.

For more information, click here.

Members Send Letter Concerning TRICARE Pharmacy Program Exclusive Contract

On June 26, Rep. Carter (R-GA) and 20 other representatives sent a letter to Assistant Secretary of Defense for Health Affairs Dr. Lester Martinez-Lopez and Defense Health Agency (DHA) Director Lieutenant General Telita Crosland, concerning the DHA’s decision to grant an exclusive contract to a pharmacy benefit manager (PBM) to administer the TRICARE pharmacy program.

The members are concerned that the PBM denies coverage of expensive specialty drugs, increases the cost of generic drugs and engages in anti-competitive practices. They are requesting the DHA provide information on TRICARE pharmacies, care denials and network adequacy requirements.

The letter was also signed by Sens. Warren (D-MA), Rounds (R-SD) and Welch (D-VT).

For more information, click here.

Members Send Letter Concerning AI and Algorithms Used For MA Prior Authorizations

On June 25, Rep. Chu (D-CA) and 45 other members of Congress sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure concerning the use of artificial intelligence (AI) and algorithmic software by Medicare Advantage (MA) providers during prior authorization coverage decisions. The members are concerned these tools result in erroneous denials of care for beneficiaries and are urging CMS to:

  • Clarify the specific elements that must be contained in denial notices;
  • Establish an approval process to review AI and algorithmic tools and their inputs;
  • Review algorithms and AI tools currently being used;
  • Prohibit the use of AI/algorithmic tools and software in coverage denials until a systematic review of their use can be completed;
  • Clarify how CMS distinguishes between uses of algorithms or software that account for individual circumstances and those that do not; specify what criteria, methods or data will be used to determine their distinction; and clarify how this requirement will be enforced and communicated to plans;
  • Outline when MA organizations are able to use internal coverage criteria when making medical necessity determinations for basic Medicare benefits; and
  • Impose a minimum time period during which MA plans cannot issue a termination notice after their prior termination decision has been reversed by a Medicare contractor.

The letter was also signed by Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) and Sens. Warren (D-MA), Smith (D-MN), Braun (R-IN) and Brown (D-OH).

For more information, click here.

Members Send Letter Concerning March-In Rights

On May 29, Reps. Buchanan (R-FL) and Smith (R-NE) and Sens. Blackburn (R-TN) and Tillis (R-NC) sent a letter to Director of the National Institute of Standards and Technology (NIST) and Undersecretary of Commerce for Standards and Technology Laurie Locascio, expressing their concern over a Draft Interagency Guidance Framework for Considering the Exercise of March-in Rights.

The members are concerned that allowing the federal government to invoke march-in rights to force a patent holder to share the intellectual property of their product if they refuse to adjust the product’s price will:

  • Stifle competition;
  • Decrease innovation; and
  • Hinder public-private collaboration and the development of new products.

For more information, click here.

Senate

Senate Finance Committee Chairman Sends Letter Concerning PBM Contracting Practices

On June 24, Senate Finance Committee Chairman Ron Wyden (D-OR) sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, urging CMS to strengthen oversight and regulatory enforcement of Medicare Part D program requirements for plan sponsors and pharmacy benefit managers (PBMs).

The chairman is concerned that PBMs are not adhering to a CMS final rule that prohibits plan sponsors and PBMs from retroactively assessing direct and indirect renumeration fees or claims submitted by pharmacies under Medicare Part D. The chairman is urging CMS to:

  • Enforce “Any Willing Pharmacy” requirements by ensuring that PBMs reimburse pharmacies at a minimum of the cost to acquire and dispense covered prescription drugs;
  • Enforce through auditing, the pharmacy price concessions provision included in the CMS Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Program final rule, which requires all pharmacy price concessions be applied to negotiated prices at the point of sale under Part D;
  • Implement standardized pharmacy measures, including evaluation and reporting or plan performance measures that CMS has finalized in pending rulemaking;
  • Review formal and informal complaints about PBM contracting practices under Part D received during the past 18 months to determine if the number of complaints is higher than in prior years; and
  • Provide information within 60 days, on the number of formal or informal complaints received about PBM contracting practices during the past 18 months, a description of the type of complaints received and their disposition.

For more information, click here.

Senators Send Letter Concerning Medicare Beneficiary Access to Diagnostic Scans

On June 25, Sen. Blackburn (R-TN) and 14 other senators sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, urging CMS to strengthen Medicare beneficiary access to Positron Emission Tomography and Single Photon Emission Computed Tomography diagnostic scans.

The senators request that CMS address packaging of payment for diagnostic radiopharmaceuticals in the upcoming calendar year 2025 rulemaking on Hospital Outpatient Prospective Payment System to expand access to diagnostic scans in hospital outpatient settings.

For more information, click here.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.