THIS WEEK’S DOSE

The House’s scheduled Memorial Day recess was cut short after President Biden and House Speaker McCarthy (R-CA) announced last weekend that they had reached a deal on raising the debt limit. The House quickly took up the package, advancing the bill by a bipartisan vote of 314–117 on May 31, and the Senate acted June 1 to pass the bill by a bipartisan vote of 63–36, successfully averting a debt default.

CONGRESS

House and Senate Consider Debt Limit Package. On May 27, President Biden and House Speaker McCarthy reached an anxiously awaited agreement to raise the federal debt limit. In addition to raising the debt limit into 2025, the Fiscal Responsibility Act (H.R. 3746) includes government spending cuts, addresses the speed of permitting for energy projects, redirects $20 billion from the Internal Revenue Services to other agencies, makes modest reforms to the student loan program, modifies work requirements for the Temporary Assistance to Needy Families program and the Supplemental Nutrition Assistance Program (but does not touch Medicaid work requirements), establishes a new administrative Pay-As-You-Go (PAYGO) requirement for executive branch rules that would increase direct spending, and rescinds $28 billion in unspent COVID-19 funding. Many of these policies involve nuances and time limits that will impact how they work, and we’ll learn more as implementation moves forward.

The policy changes in the carefully crafted agreement allow both Republicans and Democrats to find points that fit their own narratives for supporting the measure. Republicans can note that there are several real cuts and policy changes. Democrats can state that they protected Medicare, Medicaid and Social Security and echo the most common refrain heard from Democrats—it could have been much worse. Of course, members on both sides of the aisle can also find policy rationales in the deal to express their opposition.

After the agreement was announced, Speaker McCarthy and his team moved quickly to call the House back from a previously scheduled recess and begin consideration of H.R. 3746. On May 30, the package cleared its first procedural hurdle, advancing out of the House Rules Committee by a narrow partisan margin. The bill then proceeded to the House floor on May 31, where it passed by a strong bipartisan vote of 314–117, with 149 Republicans and 165 Democrats voting to support the bill. The vote was a notable victory for Speaker McCarthy, who was able to hold together a significant percentage of his often-fractious caucus. That credit extends to President Biden and House Minority Leader Jeffries (D-NY), as the leadership trio demonstrated their ability to work together to advance necessary legislation in a divided government.

The bill quickly moved to the Senate, where it was passed by a bipartisan vote of 63–36, successfully averting a debt default. During consideration of the bill, much of the concern came from Senate Republicans, who demanded a written statement from Senate leaders committing not to block supplemental defense funding and consideration of appropriations bills. Senate Democrats also raised concerns regarding other domestic priorities. A total of 11 amendments were offered to the bill, all of which failed. The swift Senate passage of the bill marks a victory for Congress in averting the debt default deadline. The legislation now heads to the President’s desk to be signed into law.

ADMINISTRATION

CMS Withdraws COVID-19 Vaccination Mandate, Enhances Focus on Quality Measures. On May 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule formally rescinding the Omnibus COVID-19 Health Care Staff Vaccination interim final rule. With this withdrawal, various Medicare and Medicaid certified healthcare facility types are no longer required to enforce COVID-19 vaccination among all staff and contractors. CMS notes, however, that it will now use quality reporting and value-based measures and incentives to encourage entities to keep workers “up-to-date” on COVID-19 vaccinations. The final rule also acknowledges staffing challenges created by the vaccine mandates and makes permanent policies requiring long-term care providers to educate and offer COVID-19 vaccines to staff and residents.

The final rule is expected to be published on June 5, 2023, and will become effective 60 days after the date of publication in the Federal Register. CMS explicitly notes, however, that it will use enforcement discretion even prior to the 60-day effective date and will no longer enforce the staff vaccination provisions.

CMS Announces Plan to Ensure Availability of New Alzheimer’s Drugs. On June 1, CMS Administrator Chiquita Brooks-LaSure announced how beneficiaries can obtain Medicare coverage for drugs that may slow the progression of Alzheimer’s disease. The agency noted that if the US Food and Drug Administration (FDA) grants traditional approval, then Medicare will cover the drugs in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare. The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will discuss the results of a confirmatory trial of the Eisai product Leqembi on June 9, with a decision on traditional approval possible within weeks. Broader Medicare coverage would begin on the same day that FDA grants traditional approval.

Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world via a registry. Clinicians will be able to submit this evidence through a nationwide CMS-facilitated portal that will be available when any product gains traditional approval and will collect information via an easy-to-use format. Other registries for drugs that may slow the progression of Alzheimer’s disease may become available in the coming weeks and months. Information will be available here as studies come online. Read the full CMS press release here.

QUICK HITS

• Dr. Mandy Cohen Expected to Be Nominated to Lead CDC. It is being circulated that President Biden plans to appoint Mandy Cohen as the next director of the CDC. Mandy Cohen is an internal medicine physician who also has a degree in public health.  She recently served as North Carolina’s Secretary of Health and Human Services for five years – managing their response to COVID. Prior to that, she worked in President Obama’s administration as a senior official at CMS in multiple roles. She currently works as chief executive officer of Aledade Care Solutions and an executive vice president at Aledade Inc., advancing accountable care organizations. President Biden is expected to make a formal announcement later this month.

• New MEDPAC Members. The US Government Accountability Office (GAO) announced the appointment of three new members to the Medicare Payment Advisory Commission, as well as the reappointment of three current members, one of whom will continue to serve as chair. The newly appointed members, whose terms began in May 2023 and will expire in April 2026, are R. Tamara Konetzka, PhD, and Brian Miller, MD, MBA, MPH. Gina Upchurch, RPh, MPH was also appointed. She is serving the remaining term for a member who resigned, so her term will expire in 2024. The reappointed members, whose terms will expire in April 2026, are Michael E. Chernew, PhD, Betty Rambur, PhD, RN, FAAN, and Wayne Riley, MD, MPH, MBA.

• RSV Vaccine Approval. On May 31, the FDA approved Pfizer’s respiratory syncytial virus vaccine Abrysvo for older adults. In late-stage clinical trials, the Pfizer vaccine was more than 66.7% effective at preventing mild cases of RSV and more than 85% effective against more moderate cases. RSV has been shown to be particularly dangerous for infants and older adults. The Centers for Disease Control and Prevention (CDC) estimates that the virus causes up to 160,000 hospitalizations annually for adults older than 65 in the United States, and causes up to 13,000 deaths. Pfizer has also asked the FDA to approve its RSV vaccine for pregnant individuals that offers protection to their fetuses. The FDA will decide whether to approve this vaccine by August. The CDC Advisory Committee on Immunization Practices will meet on June 21 to discuss recommendations for the appropriate use of RSV vaccines in older adults.

• HHS Announces New 988 Grants. On May 25, the US Department of Health and Human Services, through the Substance Abuse and Mental Health Services Administration, awarded 13 grants to communities to create and enhance mobile crisis response teams. The teams will respond to mental health and substance use crises in high-need areas, in coordination with local law enforcement. These new awards build on mobile crisis grants awarded last year and other efforts to support crisis care tied to the 988 Suicide & Crisis Lifeline. Recipients of this funding are required to build crisis system capacity by providing post-crisis follow-up, developing and implementing protocols for coordination with law enforcement, providing evidence-based crisis training to providers and first responders, mapping community crisis systems and improving use of data.

• Medicaid Unwinding. Kaiser Family Foundation released an analysis on early Medicaid unwinding data. Early data from a handful of states reveal wide variation in disenrollment rates. Data from 11 states show that more than half a million enrollees have already been disenrolled. In nine states that reported both total completed renewals and total disenrollments, the disenrollment rate ranges from 54% in Florida to just 10% in Pennsylvania and Virginia. The early data also reveal high rates of procedural disenrollments in some states. The share of procedural disenrollments, which occurs when people are disenrolled because they did not complete the enrollment process and may or may not still be eligible for Medicaid, exceeds 80% in Arkansas, Indiana and Florida, and was almost 55% in Iowa.

• Nurse Staffing Ratios. A CMS proposed rule regarding minimum staffing standards is pending review at the Office of Management and Budget (OMB). The proposed rule is titled Minimum Staffing Standards for Long-Term Care Facilities (CMS-3442) and was received by OMB on May 30.

NEXT WEEK’S DIAGNOSIS

The House and Senate are both in session next week, with healthcare activity expected at the committee level. This includes a House Energy and Commerce Oversight and Investigations Subcommittee hearing focused on the CDC, an anticipated House Education and Workforce Committee markup of bills impacting employer-sponsored health coverage, an anticipated House Ways and Means Committee markup of health savings account legislation, a Senate Finance Committee hearing on health care consolidation, and a Senate Health Education Labor and Pensions (HELP) Committee hearing on youth mental health.