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June 30, 2024

This Week in Health Policy for July 1

This Week (July 1 - 5)

This week, Congress will be in recess for the Fourth of July holiday. This Week in Health Policy will not publish while Congress is away.

Last Week (June 24 - 28)

Health Care Highlights

Supreme Court rulings with health care implications. Last week, the Supreme Court issued several rulings that have implications for health care:

  • On Friday (June 28), the Supreme Court in a 6-3 ruling overturned the court's 1984 decision in Chevron v. Natural Resources Defense Council, ruling that courts may not defer to an agency interpretation of the law simply because a statute is ambiguous. The ruling changes decades of legal precedent and could have implications for federal regulators' ability to issue rules related to health, the environment, labor, and employment.
  • On Thursday (June 27), the Supreme Court ruled 6-3 to dismiss as premature the appeal of a lower-court decision that invalidated an Idaho law limiting abortion care to instances in which the pregnant person's life is at risk. The ruling allows emergency abortions to be performed in Idaho. The court did not rule on the merits of the case.
  • On Thursday (June 27), the Supreme Court ruled 5-4 to overturn a settlement related to the opioid epidemic with Purdue Pharma that included legal protections for the Sackler family from opioid victims' cases.
  • On Monday (June 24), the Supreme Court declined to hear a case brought by Home Depot and other health plan sponsors challenging the nearly $2.7 billion Blue Cross Blue Shield 2020 settlement over whether BCBS plans anti-competitive behavior violated the rights of health care purchasers. The Court's refusal to hear the case will leave the settlement in place.

House takes up appropriations bills. On Friday (June 28), the House voted 217-198, largely along party lines, to pass an $833 billion fiscal year (FY) 2025 defense appropriations bill that includes controversial policy riders including restrictions for abortion care and gender-affirming care. The House also voted 212-200, along party lines, to pass the FY 2025 State, Foreign Operations, and Related Programs appropriations bill, which includes a policy to ban groups that promote abortion rights from receiving US global health funding, as well as additional funding to combat fentanyl from entering the US.

CMS publishes Cell and Gene Therapy (CGT) Access Model request for applications On Friday (June 28), CMS released a request for applications for states that wish to participate in the Cell and Gene Therapy (CGT) Access Model. The model will test whether outcomes-based agreements for cell and gene therapies improves Medicaid beneficiaries' health outcomes, improves access to treatment, and reduces spending. There is expected to be widespread interest in participation. Fact sheet.

CMS issues CY 2025 Home Health Prospective Payment System proposed rule. On Thursday (June 27), CMS issued the CY 2025 Home Health Prospective Payment System proposed rule. While CMS proposed a 2.5% payment increase for home health providers, it estimates that the net effect of other policy changes, including a statutorily required -4.067% adjustment to account for the impact of implementing the Patient-Driven Groupings Model (PDGM), would reduce home health payments by an estimated $280 million, or 1.7%, in CY 2025, compared with CY 2024. The rule also includes proposed revisions to home health quality standards and the Home Health Quality Reporting Program (HHQRP), as well as requests for information (RFI) on measure concepts for the HHQRP and Home Health Value Based Purchasing (HHVBP) demonstration project, the feasibility of rehabilitative therapists conducting the comprehensive assessment and the overall scope of Home Health Agency services. CMS is accepting public comments through August 26. Fact sheet, Proposed rule

CMS issues CY 2025 ESRD Prospective Payment System proposed rule. On Thursday (June 27), CMS released the CY 2025 End-Stage Renal Disease (ESRD) PPS proposed rule, which includes a base payment rate of $273.20. This represents an increase of 2.2% from the final CY 2024 base payment rate. The proposed rule also includes an update to equalize the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for 2025 with the overall base rate and proposes to extend Medicare payment to dialysis in the home setting for beneficiaries with acute kidney injury. The rule also includes updates to the ESRD Quality Incentive Program. CMS will accept comments on the proposed rule until August 26. Fact sheet, Proposed rule.

CMS issues latest Medicare Part B inflation rebate drug list. On Wednesday (June 26), CMS released the latest list of drugs subject to the Medicare Part B inflation rebate program. The selected drugs will result in lower Part B coinsurance for beneficiaries from July 1 to September 30, calculated as 20% of the inflation-adjusted payment amount. Fact sheet.

FDA issues draft guidance on clinical trial diversity. On Wednesday (June 26), the Food and Drug Administration (FDA) issued draft guidance providing new details on the format and content of clinical trial diversity action plans, the types of studies for which they are required, and the timing and process for submitting action plans to the agency, nearly six months after its statutorily required deadline. The guidance also explains the criteria and process FDA will use to evaluate waiver requests. FDA will accept comment on the draft guidance until September 26.

CMS issues FAQ on PrEP for HIV National Coverage Determination. On Tuesday (June 25), CMS published a new FAQ providing technical information on how to submit Medicare Part B claims for Pre-exposure Prophylaxis (PrEP) Using Antiretroviral Drugs to Prevent HIV Infection in advance of a final National Coverage Determination.

US Surgeon General calls firearm violence a public health crisis. On Tuesday (June 25), US Surgeon General Dr. Vivek Murthy issued an advisory declaring firearm violence in America to be a public health crisis. The advisory highlights the number of firearm-related deaths, the impact of firearm violence on communities and families, factors contributing to firearm violence, and a public health approach to firearm injury and prevention.

OIG issues final rule implementing provider disincentives for information blocking. On Monday (June 24), the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a final rule that establishes disincentives for health care providers found to have committed information blocking. Under the rule, eligible hospitals or critical access hospitals that commit information blocking will not be considered a meaningful user of electronic heath records (EHRs) during that calendar year under the Promoting Interoperability program and individual MIPS providers will not be considered a meaningful EHR provider. Providers participating in the Medicare Shared Savings Program that commit information blocking will have their eligibility suspended for at least one year. Press release , Final rule.

Hearings, Markups, and Other Committee Activity

House Energy and Commerce Committee cancelled a markup of data privacy, telehealth, and other legislation. On Thursday (June 27), the Committee at the last minute canceled the mark up in the wake of Republican leadership concerns with the American Privacy Rights Act, particularly the bill's private right of action provision. In a statement, Ranking Member Frank Pallone (D-NJ) criticized the interference that resulted in the markup being canceled. It is unclear when the markup, which included legislation to extend Medicare telehealth flexibilities set to expire at the end of 2024 through 2026, may be rescheduled. Chair Cathy McMorris Rodgers (R-WA), who is retiring at the end of the year, said in a statement "we will continue our pursuit to give Americans privacy rights online."

  • More information available here.

House Ways & Means Committee held a markup of H.R. 1691, H.R. 2407, H.R. 8816, and H.R. 4818. On Thursday (June 27), the Committee advanced four bills to create a transitional coverage pathway for FDA-approved breakthrough devices under the Medicare program, to enable Medicare to cover FDA-approved multi-cancer early detection screening tests, to provide a cognitive impairment screening under Medicare, and to expand Medicare coverage for obesity drugs and intensive behavioral therapy. During the markup, there was strong bipartisan support for advancing the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, with the committee taking a moment to applaud the bill's unanimous passage. Much of the markup's discussion focused on the Treat and Reduce Obesity Act of 2023, which would allow Medicare to cover of obesity drugs. Several Democrats raised concerns about the amended bill, which significantly scales back eligibility for Medicare beneficiaries to those who are already taking it, reducing the bill's cost to $1.7 billion over a decade. While members who spoke in support of the bill viewed it as an important first step to increasing access to weight loss drugs, Democrats who raised concerns said the bill imposes "arbitrary" limits on who is eligible for coverage that does not account for patient need.

  • More information available here.

House Judiciary Subcommittee on the Administrative State, Regulatory Reform, and Antitrust held a hearing on "Follow the Science?: Oversight of the Biden Covid-19 Administrative State Response." On Wednesday (June 26), the Subcommittee held an oversight hearing on the Biden administration's COVID-19 response. During the hearing, discussion focused on the FDA's process for authorizing COVID-19 vaccines and boosters and the Biden administration's decision to issue a vaccine mandate.

  • More information available here.

House Appropriations Labor, Health and Human Services, Education, and Related Agencies held a "markup of the fiscal 2025 Labor-HHS-Education bill." On Thursday (June 27), the Subcommittee advanced a FY 2025 Labor-HHS-Education appropriations bill that would cut the HHS budget by 7% and reorganize the National Institutes of Health. The bill also includes restrictions related to abortion care and gender-affirming care that are strongly opposed by Democrats. It is unlikely to be approved by the Senate.

  • More information available here.

House Veterans' Affairs Subcommittee on Health Oversight held a hearing on "The Continuity of Care: Assessing the Structure of VA's Healthcare Network." On Wednesday (June 26), the Subcommittee held a hearing during which lawmakers heard testimony from Veterans Health Administration officials, the VA Office of Inspector General, and academics. The hearing largely focused on the organizational structure of the VA health care system and ways to address organizational gaps and improve veteran care.

  • More information available here.

House Ways & Means Committee will hold a hearing on "Health Subcommittee Hearing on Improving Value-Based Care for Patients and Providers." On Wednesday (June 26), the Subcommittee held a hearing on "Improving Value-Based Care for Patients and Providers." During the hearing, there was consensus among members and witnesses that the current fee-for-service health care system generates higher costs and poorer patient care. Both Republicans and Democrats expressed frustration with the slow transition to value-based payment models, with several members critiquing the Center for Medicare and Medicaid Innovation (Innovation Center). Witnesses and members spoke about the need to better align incentives toward care value and ensure more accurate benchmarking in models, with Ranking Member Lloyd Doggett (D-TX) and Dr. Robert Berenson of the Urban Institute emphasizing the need to correct the Medicare Physician Fee Schedule (MPFS). Several lawmakers and witnesses also spoke about ways value-based payment models can help mitigate workforce shortages by building out care teams of clinical and non-clinical providers and ensuring everyone operates at the top of their license.

  • More information available here.

House Committee on Education & the Workforce Subcommittee on Health, Employment, Labor, and Pensions will hold a hearing on "Examining the Policies and Priorities of the Employee Benefits Security Administration." On Thursday (June 27), the Subcommittee held a hearing during which lawmakers questioned Lisa Gomez, Assistant Secretary of the Employee Benefits Security Administration (EBSA), on EBSA's policies and priorities. Throughout the discussion, Republicans pressed Gomez on the administration's stance on ERISA preemption, with Chairwoman Virginia Foxx (R-NC) asking her to commit to defending strong preemption moving forward, to which Gomez said they would evaluate each case as appropriate. Republicans also criticized the administration's efforts to pull back on Trump-era Association Health Plan (AHP) and short-term limited duration insurance regulations, while Democrats such as Bobby Scott (D-VA) applauded the move and said they can lead to Americans paying more for health care with less protections. Gomez also said that advancing mental health parity is a top priority for them, but would not give a firm update on when to expect the final rule, and noted the difficulty in having a comprehensive enforcement strategy for private health plans given inadequate staffing levels. She and Democrats on the committee both expressed the need for more agency funding.

  • More information available here.

Reports, Studies, and Journals

Congressional Budget Office: The Effects of Permanently Extending the Expansion of the Premium Tax Credit and the Costs of that Credit for Deferred Action for Childhood Arrivals Recipients. CBO projects that permanently expanding enhanced subsidies to purchase coverage on the ACA's exchanges would increase the deficit by $335 billion over a decade and increase the overall number of people with insurance by 3.4 million, with a 6.9 million net increase in marketplace coverage enrollees, a 3.5 million decrease in those enrolling in employer-based coverage and a 500,000 decrease in those enrolling in nongroup coverage purchased off the exchanges.

HHS Office of Climate Change and Health Equity: Catalytic Program on Utilizing the Inflation Reduction Act. The office published case studies showcasing how two not-for-profit safety-net health care providers are using the Inflation Reduction Act's environmental provisions to reduce carbon emissions.

Health Affairs: The United States Needs A Better Testing Playbook For Future Public Health Emergencies. The analysis explores a comprehensive national playbook for developing and deploying testing in biological emergencies and ways to address gaps in the US' pandemic response.

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Contact Information

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Washington Council Ernst & Young