Health Care Checkup: June 7, 2024

Health Care Checkup

June 7, 2024

THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS

On Thursday, Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) have announced a request for information (RFI) to provide input on how Congress can help spur the next generation of life-changing treatments and ensure that patients can access them. The efforts build upon the 21^st Century Cures Act and Cures 2.0 to continue the ongoing process of reform.

On Wednesday, Senate Finance Committee Chair Ron Wyden (D-OR) urged the Department of Health and Human Services (HHS) to immediately mandate that systemically important health care companies improve their cybersecurity practices.

Multiple committees of jurisdiction held health hearings this week on the 340B drug pricing program, abortion bans, and examining former NIH director Dr. Anthony Fauci on the origins of the COVID-19 pandemic.

Late last week, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) published an update clarifying that covered healthcare entities affected by the Change Healthcare hack can contact Change and direct it to provide the notifications on their behalf.

What to Expect Next Week:

Elizabeth Fowler, director of the Center for Medicare and Medicaid Innovation, will testify on Thursday before the House Energy and Commerce Subcommittee on Health on value-based care. The House Energy & Commerce Committee may also conduct a full committee markup of bills considered in the subcommittee.

In the Senate, the Senate Judiciary Committee will hold a hearing on Wednesday, examining abortion bans and interstate travel for care after Dobbs. The Senate will also consider the IVF bill, the Right to IVF Act (S. 4445).

DEEP DIVE

Congressional:

House Committee On COVID-19 Holds Hearing with Former NIAID Director, Fauci

On Monday, Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases, testified before the House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic. During the hearing, Fauci pushed back on claims by Republicans on the committee that he tried to squelch the theory that the virus spilled over from a lab in Wuhan, China. Fauci stated he has kept an open mind on the pandemic's origins but has endorsed a theory that the disease came from an animal. Fauci also said of his longtime Fauci adviser, David Morens, that Morens was not part of his inner circle, stating, “Despite his title, and even though he was helpful to me in writing scientific papers, Dr. Morens was not an adviser to me on institute policy or other substantive issues.” Read Fauci’s testimony here.

House Energy & Commerce Committee Examines 340B Program

On Tuesday, the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing examining the 340B Program. During the hearing, members were largely divided on party lines on the future of the 340B discount drug pricing program, with Republicans pushing changes to the federal program and Democrats defending it. Republican leadership on the committee stated some hospitals were taking advantage of the program, and increased transparency was needed to ensure hospitals are using 340B savings to serve the intended patients. Ranking Members Frank Pallone and Kathy Castor voiced their support for the 340B program and stated concerns that proposed Republican changes could be detrimental to hospitals and not yield significant savings. Read Mehlman’s hearing summary here.

Senate HELP Committee Holds Hearing on Abortion Bans

On Tuesday, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing titled “The Assault on Women’s Freedoms: How Abortion Bans Have Created a Health Care Nightmare Across America.” Witnesses included the Chief Medical Officer for Planned Parenthood of Wisconsin, the CEO of the American Association of Pro-Life Obstetricians and Gynecologists physicians, and an abortion patient, among others. Read the witness testimonies here.

Reps. DeGette and Bucshon Announce RFI on the 21^st Century Cures Act

Sen. Wyden Urges HHS to Require Mandatory Cybersecurity Defenses for Large Health Care Companies

On Wednesday, Senate Finance Committee Chair Ron Wyden (D-OR), urged the Department of Health and Human Services (HHS) to immediately mandate systemically important health care companies to improve their cybersecurity practices. In the letter, Wyden asked HHS to immediately put in place new security rules, including establishing minimum technical cybersecurity and resiliency standards, performing periodic audits, and providing technical assistance to providers, particularly those with low resources. Read the press release here and the letter here.

Pallone & Nadler Commend Biden Administration's Inquiry into the Impacts of Private Equity & Corporate Greed on Health Care

On Thursday, House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) and House Judiciary Committee Ranking Member Jerrold Nadler (D-NY) wrote a letter to the Department of Justice (DOJ), Federal Trade Commission (FTC), and the Department of Health and Human Services (HHS) commending the Biden Administration for opening a public inquiry into how private equity and corporate greed have affected Americans’ health care. The Committee leaders’ letter highlights key concerns about private equity’s growing role in the health care system. The Ranking Members also underscored their continued alarm over the role private equity has played in rising health care costs and surprise medical bills. Read the press release and letter here.

31 Senators Back Senate Joint Resolution to Block Biden Nursing Home Rule

On Tuesday, Sen. James Lankford (R-OK) introduced a joint resolution Tuesday evening that would block the Biden administration from implementing a rule mandating minimum nurse staffing levels in nursing homes. Thirty senators, including Joe Manchin (I-WV) and Jon Tester (D-MT), joined Lankford in introducing the measure (S.J. Res 91), which would, under the Congressional Review Act, block the staffing rule. The rule, finalized in April, will require 3.48 hours of daily care per resident, with 0.55 hours of that care coming from registered nurses. Nursing homes would also be required to have a nurse on duty 24 hours a day, seven days a week. A Congressional Review Act resolution needs a simple majority of votes to pass but would need a two-thirds majority to overcome a presidential veto. Read the press release here.

Senate Tees up IVF Vote After Contraception Rights Bill Fails

On Wednesday, Senate Republicans blocked the Right to Contraception Act (S. 4381), which would codify the right to access contraception, in a 51-39 procedural vote. Senate Majority Leader Chuck Schumer (D-NY) stated that the Senate will bring up the Right to IVF Act (S. 4445) next week, and he expects to hold more votes as well.

Senate Democrats Pressure Biden Administration to Finalize Mental Health Parity Rule

On Thursday, a group of Senate Democrats sent a letter to Biden administration officials asking the administration to finalize the rule requiring insurers to provide mental health care parity. The effort led by Sen. Chris Murphy (D-CT) alongside Sens. Peter Welch (D-VT), Alex Padilla (D-CA), Ed Markey (D-MA), Tina Smith (D-MN), Amy Klobuchar (D-MN) and Ben Ray Luján (D-NM), urges the Biden administration to stay the course as the measure would make a significant dent in the nation’s mental health and substance use disorder crises. The Treasury Department has targeted June to finalize the rules. Read the letter here.

Reps. Van Duyne, Cleaver Lead Effort to Ensure Safe and Efficient Organ Transportation

Late last week, Reps. Beth Van Duyne (R-TX-24) and Emanuel Cleaver (D-MO–05) led a bipartisan group of lawmakers in urging the Department of Transportation (DOT) and Federal Aviation Administration (FAA) to carry out the creation of a working group to develop best practices and identify hindrances for transporting donated organs in the cabin of commercial aircrafts. The FAA Reauthorization Act of 2024, which was signed into law on May 16, 2024, contained a provision requiring the DOT and FAA to form a working group within 90 days. Read the press release and letter here.

Notable Bills Introduced:

Sens. Duckworth, Murray, Booker Introduce Legislative Package to Establish a Nationwide Right to IVF and Lower IVF Costs

On Monday, Senators Tammy Duckworth (D-IL), Patty Murray (D-WA), and Cory Booker (D-NJ) introduced a legislative package that would establish a nationwide right to in-vitro fertilization (IVF) and other assisted reproductive technology (ART) and require insurers to cover IVF treatment. Read the press release here and the bill here.

Sens. Cardin and Blackburn Introduce CKD Bill to Improve Research and Treatment

On Wednesday, Senators Ben Cardin (D-MD) and Marsha Blackburn (R-TN) introduced S. 4469, the Chronic Kidney Disease Improvement in Research and Treatment Act of 2024. Similar to the House companion bill (H.R. 5027), the Chronic Kidney Disease Improvement in Research and Treatment Act of 2024, would make important strides toward prioritizing early kidney disease detection and screening, create important long-term pathways for innovation in the ESRD PPS, ensure access to care and coverage, and boost a sustainable kidney care workforce. Read the bill here.

Executive Branch:

HHS Allows Hospitals To Push Patient Hack Notifications to UnitedHealth

Late last week, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) published an update to the frequently asked questions (FAQs) webpage concerning the Change Healthcare cybersecurity incident. The update clarified that covered healthcare entities affected by the hack can contact Change Healthcare and direct it to provide the notifications on their behalf. OCR added in a press release that the providers will not be subject to any additional requirements under HIPAA. UnitedHealth Group said the insurer welcomed the move. Read the press release here.

Secretary Becerra Calls For Mandatory Indian Health Service Funding After Supreme Court Ruling

In light of a Thursday Supreme Court ruling, Health and Human Services Secretary Xavier Becerra is urging Congress to shift funding for the Indian Health Service budget from discretionary to mandatory spending beginning in fiscal 2026. The Supreme Court ruled 5-4 in an opinion written by Chief Justice John Roberts that the government must reimburse Indian tribes for administrative costs associated with third-party payers like Medicare, Medicaid, and private insurers. The case centered on the interpretation of the Indian Self-Determination and Education Assistance Act, which allows tribes to take over the administration of health care programs that would otherwise be run by IHS. Becerra stated that Congress should act on Biden's latest budget request to shift the IHS budget from discretionary to mandatory funding to "protect the overall appropriation for the Indian Health Service and create more adequate and stable funding into the future." The Indian Health Service said in its congressional justification shifting to mandatory funding is necessary for "adequate, stable, and predictable funding for the Indian Health system." Read the HHS statement here.

FDA Advisory Panel Votes Against Use of MDMA for PTSD

On Tuesday, a scientific advisory panel to the Food and Drug Administration (FDA) overwhelmingly voted against recommending the use of MDMA to treat post-traumatic stress disorder. The Psychopharmacologic Drugs Advisory Committee voted 9-2 that data do not demonstrate that MDMA, more commonly known as ecstasy or molly, is effective in treating PTSD, with members of the panel questioning clinical trials of the drug's use for PTSD. 9 out of 10 panel members also voted no on whether the available data show that the benefits of treatment using MDMA outweigh the potential risks. The panel's recommendations are not binding, and the FDA is not required to follow those recommendations but typically takes such recommendations into consideration. The FDA is expected to decide on the drug's use by August 11.

FDA Approves Moderna RSV Vaccine For Older Adults

Late last week, the Food and Drug Administration approved a respiratory syncytial virus (RSV) vaccine from Moderna on Friday to protect older adults. This is the third RSV vaccine for older adults to hit the market and the second approved mRNA product from Moderna. The approval also marks the first time the FDA has approved an mRNA vaccine for a disease other than COVID-19. The mRNA shot will protect adults aged 60 and older, and the drugmaker expects to have the shot available for this population for the 2024-2025 respiratory virus season. In June, Centers for Disease Control and Prevention vaccine advisers will vote on recommendations for the vaccine's use. Read the press release here.

Legal & Other:

HHS Asks Court to Deny Motions to Block Medicare Payment Rule

On Monday, the Justice Department asked a federal court in Texas to deny separate requests for preliminary injunctions that would block an HHS rule that limits payments to “field marketing organizations” that help insurance agents and brokers enroll seniors into Medicare managed care plans. Two lawsuits that claim the Department of Health and Human Services overstepped its authority by finalizing the rule have been filed in US District Court for the Northern District of Texas. Americans for Beneficiary Choice and Senior Security Benefits LLC claimed CMS “upends the regulatory status quo, dramatically limiting administrative fees that Congress did not intend” for the CMS to regulate. A similar complaint was filed by attorneys for the Council for Medicare Choice, the Fort Worth Association of Health Underwriters, and Vogue Insurance Agency LLC. The Justice Department argued that both motions for preliminary injunctions should be denied.

Nursing Homes Sue to Stop HHS Mandatory Staffing Requirement

Late last week, the American Health Care Association (AHCA), which represents more than 14,000 nursing homes, filed suit in federal court in the US District Court for the Northern District of Texas to block a mandatory nursing home staffing rule that would require 75% of facilities to add direct-care workers or face administrative penalties and fines. AHCA claims the Department of Health and Human Services and the Centers for Medicare & Medicaid Services exceeded their statutory authority and acted arbitrarily and capriciously in finalizing the staffing requirement.