June 5, 2023
This Week in Health Policy for June 5
This Week (June 5 - 9)
The Committee on Education and the Workforce is expected to hold a markup on telehealth and other health care legislation.
House Energy and Commerce Oversight and Investigations Subcommittee will hold a hearing on "Looking Back Before Moving Forward: Assessing CDC's Failures in Fulfilling its Mission."
Senate Judiciary Subcommittee will hold a hearing on "Artificial Intelligence and Intellectual Property — Part I: Patents, Innovation, and Competition."
Senate Veterans' Affairs Committee will hold a hearing on "An Abiding Commitment to Those Who Served: Examining Veterans' Access to Long Term Care."
The House Ways and Means Committee is expected to hold a markup of health care legislation.
The Senate Finance Committee will hold a hearing on "Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs."
The Senate Health, Education, Labor & Pensions Committee will hold a hearing on "Why Are So Many American Youth in a Mental Health Crisis? Exploring Causes and Solutions."
Last Week (May 29 - June 2)
Health Care Highlights
Congress averts debt default. On Thursday (June 1), the Senate voted 63-36 to send the Fiscal Responsibility Act of 2023, which cleared the House the day before in a 314-117 vote, to President Biden's desk for his signature. The bill, which reflects a deal struck between President Biden and House Speaker Kevin McCarthy (R-CA), suspends the debt ceiling through early 2025, curbs government spending, claws-back IRS and COVID-related funding, and other items.
The bill would rescind about $28 billion in unspent COVID-19 funding allocated to various federal health care agencies as part of federal COVID-relief bills. For example, the deal would rescind portions of public health and social services emergency funding to support COVID-related prevention, preparedness and response efforts totaling over $9.9 billion, as well as funding for global health; mental health and substance use disorder training and education; the public health workforce and medical reserve corps; public health funding for community health centers and community care, National Health Services Corp., teaching health centers, and family planning; and Defense Production Act COVID-19 emergency medical supplies. However, the Biden administration said the deal retains $5 billion for the federal Project NexGen, which aims to accelerate the development of new COVID-19 vaccines and treatments, as well as funding for COVID-19 vaccines and treatments for the uninsured.
While the deal does not include Medicaid work requirements included in the House Republican-passed budget proposal — the Limit, Save, Grow Act, H.R. 2811 — it does phase in work requirements for the Supplemental Nutrition Assistance Program (SNAP) for those ages 50-54 and creates a program to implement work requirements for Temporary Assistance for Needy Families (TANF) recipients. Those provisions include exceptions for veterans, homeless people and foster youth.
The bill would establish caps on discretionary spending for FY 2024 and FY 2025: an FY 2024 defense limit of $868.349 billion and nondefense limit of $703.651 billion, growing by 1% in FY 2025 to $895.212 billion for defense and $710.688 billion for nondefense. The bill also includes a mechanism to discourage continuing resolutions, providing that if all 12 appropriations bills are not enacted by January 1 of the following year, discretionary spending will temporarily operate at a maximum of 99% of current levels. The deal also includes a new administrative PAYGO, which would require agencies to detail ways to reduce direct spending if they finalize a rule that would increase direct spending by at least $1 billion over a decade or $100 million in a single year. For rule provisions mandated by statute, agencies would have to demonstrate how they achieved the least costly implementation option.
CMS clarifies coverage for Alzheimer's drugs. On Thursday (June 1), CMS offered additional details on how patients may receive Medicare coverage for a class of drugs intended to slow the progression of Alzheimer's disease. CMS said drugs that receive traditional FDA approval will be eligible for Medicare Part B coverage if patients meet the criteria, including having a qualified physician and clinical team participating in a registry to collect real-world evidence on the drug. Currently, two Alzheimer's drugs have received FDA accelerated approval, and CMS limits coverage to those enrolled in clinical trials. FDA in the coming weeks will consider traditional approval of one of the drugs, Eisai's Leqembi.
Supreme Court rules in anti-trust case. On Thursday (June 1), the Supreme Court overturned a 7th Circuit Court of Appeals ruling that had determined Safeway and SuperValu pharmacies did not overcharge Medicare and Medicaid hundreds of millions of dollars for prescription drugs. The justices said the appeals court applied the wrong standard and that the pharmacies cannot claim they did not "knowingly" violate the False Claims Act.
CMS withdraws health care staff COVID vaccination requirements. On Wednesday (May 31), CMS issued a final rule withdrawing COVID-19 health care staff vaccination requirements and long-term care facility testing requirements, effective immediately. The rule notes that quality metrics that assess the proportion of health care workers who are vaccinated will remain in place. CMS proposed updated versions of those measures for FY 2024 in spring rulemaking.
FDA proposes simplified medication guides. On Tuesday (May 30), the FDA proposed a new rule to update the medication guides that come in prescription drug packages. The rule aims to simplify the information patients receive and would require essential drug information to be included on a single page using a standardized format. The new format would replace two types of FDA-approved written prescription drug patient information and certain biological product information. The rule is open for public comment for 180 days.
Hearings, Markups, and Other Committee Action
Senate Veterans Affairs Committee held a confirmation hearing for Tanya Bradsher, nominee to be deputy secretary of the Department of Veterans Affairs. On Wednesday (May 31), the Committee questioned Bradsher who told the senators that she is committed to ensuring veterans' access to resources when they leave active duty and rebuilding trust with veterans. Senators overall seemed supportive of Bradsher. Committee Chair Jon Tester (D-Mont.) said he would schedule a vote on Bradsher's nomination as soon as possible but did not specify a timeline.
Reports, Studies, and Journals
Kaiser Family Foundation: What Do the Early Medicaid Unwinding Data Tell Us? Publicly available data from 11 states that have begun the Medicaid redetermination process show more than half a million people have been disenrolled from Medicaid since April 1, with figures ranging by state from a high of nearly 250,000 people in Florida to a low of 3,000 in Nebraska.
HHS Office of Inspector General: Medicare Paid Millions More for Physician Services at Higher Nonfacility Rates Rather Than at Lower Facility Rates While Enrollees Were Inpatients of Facilities. The report found Medicare made overpayments totaling $22,463,193 for 1,130,182 claim lines by paying the higher nonfacility rate rather than the lower facility rates for physician services for services coded as furnished in a nursing facility or SNF setting without Part A coverage while enrollees were a Part A SNF or hospital inpatients.
Congressional Budget Office: CBO's Estimate of the Budgetary Effects of H.R. 3746, the Fiscal Responsibility Act of 2023. The report states that the bill, if enacted and appropriations were limited to the bill's caps, would reduce CBO's projections of budget deficits by about $1.5 trillion over the 2023—2033 period relative to its May 2023 baseline projections.
HHS Office for Civil Rights: Language Access Annual Progress Report. The report highlights action taken by HHS to improve access to language assistance services for those with limited English proficiency, as well as future steps the department can make.