Health Care Checkup: March 15, 2024

Health Care Checkup

March 15, 2024

THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS

On Monday, President Biden released his budget proposal for fiscal year (FY) 2025. The budget request seeks to raise the Health and Human Services Department’s (HHS) discretionary spending to $133.8 billion, a nearly $5 billion increase from fiscal year 2023. The HHS budget plan is central to Biden’s plan for reducing costs and includes expanding the number of drugs subject to negotiation and extending the $2,000-per-year out-of-pocket cap on drug costs from Medicare to private plans.

On Sunday, the Department of Health and Human Services (HHS) told health care leaders that the agency is urging UnitedHealth Group to take responsibility for the impact of a massive cyberattack on Charge Health Care that has delayed provider payments. Separately, on Wednesday, the HHS Office of Civil Rights (OCR) announced a probe into whether the Change Healthcare hack resulted in the disclosure of private patient information.

What to Expect Next Week:

The next six-bill package for the remainder of the federal government spending bills is expected to be released this weekend. The deadline is March 22.

HHS Secretary Becerra will continue to discuss the HHS proposed fiscal 2025 budget next week at hearings with the House Appropriations Health Subcommittee and the House Ways and Means Committee on Wednesday.

Also, on Wednesday, the House Energy and Commerce Health Subcommittee will hold a hearing to examine the FDA’s proposed rule to regulate laboratory-developed tests.

DEEP DIVE

Congressional:

House Energy and Commerce Health Subcommittee Advances 19 Bills

On Tuesday, the House Energy and Commerce Health Subcommittee held a markup, advancing 19 healthcare bills, most of which were bipartisan. The legislation included many bills reauthorizing programs, legislation to tackle provider burnout, continuing programs for traumatic brain injuries, boosting rural emergency medical services, and extending the National Alzheimer’s Project. Two bills saw some opposition from Democrats. The Kidney PATIENT Act, which would delay CMS from moving oral-only drugs for chronic kidney disease into a different payment system that backers argue would restrict access and increase costs, advanced in a 16-10 vote despite concerns from full committee ranking member Frank Pallone (D-NJ) that it would hurt access to care and raise costs. Another bill was the Seniors’ Access to Critical Medications Act of 2023, which would permanently allow independent doctors to send prescriptions via mail, advanced in a 19-6 vote despite concerns from Pallone over fraud risk. Read Mehlman’s markup summary here.

Senate Finance Committee Holds Hearing on President’s FY2025 HHS Budget

On Thursday, the Senate Finance Committee held a hearing with the Department of Health and Human Services (HHS) Secretary Xavier Becerra to examine President Biden’s proposed fiscal year 2025 budget for HHS. Speaking before the committee, Secretary Becerra defended the White House's $130.7 billion discretionary funding request for HHS and reiterated the president's calls for Congress to implement proposals to reduce the cost of prescription drugs and cap out-of-pocket costs. During the hearing, Senate Finance Committee Chair Wyden (D-OR) and Ranking Member Crapo (R-ID) reiterated their calls for their bipartisan drug pricing legislation and pharmacy benefit manager (PBM) reform (S 2973, S 3430), which the committee overwhelmingly advanced last year. Secretary Becerra confirmed to the Committee that HHS was willing and prepared to work with Congress on PBM reform. Members also spoke on a wide range of topics, including the recent cyber-attack on Change Health Care and a lack of cybersecurity standards for healthcare, HHS responses to various measures in the Inflation Reduction Act, HHS responsibility for unaccompanied minors and screening of sponsors, and the Biden Administration’s proposed rule for mandated nursing home staffing ratios. Read Mehlman’s hearing summary here.

Senators Wyden, Crapo Hold Press Conferences with Pharmacists Calling for Bipartisan PBM Reforms

On Thursday, the Senate Finance Committee Chair Ron Wyden (D-OR) and Ranking Member Mike Crapo (R-ID), held a press conference with pharmacy leaders and pharmacists on the need to pass meaningful bipartisan pharmacy benefit manager (PBM) reforms. Wyden and Crapo indicated they are pushing to get the PBM provisions included in the final fiscal 2024 HHS spending bill, which is expected to be released this weekend. Crapo stated, "We have an opportunity, hopefully within the next few days, to get this legislation over the finish line." Read the press release and letter here.

Ways and Means Committee Holds Hearing on Care at Home in Rural and Underserved Communities

On Tuesday, the House Ways and Means Committee held a hearing to consider the future of telehealth, remote patient monitoring, and hospital-at-home care. During the COVID-19 pandemic, Congress temporarily lifted Medicare's geographic restrictions on telehealth while extending Centers for Medicare and Medicaid Services waivers that formed the basis of its "hospital at home" initiative. Both authorities expire on December 31. There was bipartisan support for the benefits of home-based care and telehealth services as a tool to increase healthcare access and equity, as well as the current challenges of providing these services in rural areas. Members also spoke on increasing Medicare provider reimbursement, particularly for rural areas, and employing appropriate guardrails to prevent fraud, waste, and abuse. Witnesses included patients, leading telemedicine researcher Dr. Ateev Mehrotra of Harvard Medical School; Chris Altchek, CEO of remote patient-monitoring firm Cadence; and Dr. Nathan Starr, lead hospitalist at a tele-hospitalist program at Utah-based Intermountain Healthcare and Castell Home Services. Read Mehlman’s hearing summary here.

Congressional Interest and Oversight of FDA Diagnostic Test Regulations Heats Up

The Energy and Commerce Health Subcommittee will hold a hearing on Thursday, March 21, on the issue of how diagnostic lab tests should be regulated. Negotiations to overhaul lab regulation faltered in 2022, prompting the Food and Drug Administration (FDA) to move ahead with a proposed rule to reclassify lab tests as medical devices, putting lab tests under the agency's regulatory jurisdiction. Republicans, including Energy and Commerce Chair Cathy McMorris Rodgers (R-WA) and Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) oppose the rule.

On Wednesday, Senator Cassidy announced a request for information (RFI) from stakeholders on ways to improve the regulation of clinical tests in the United States. Cassidy hopes to use the feedback on how Congress can modernize current regulations to support innovation while ensuring these clinical tests are safe and effective to use. The deadline to submit feedback is April 3, 2024. Read the press release here and the full request here.

Notable Bills Introduced:

Sens. Cassidy, Carper, Cornyn, Warner, Scott, Menendez Comprehensive Legislation Improve Care for Patients Jointly Enrolled in Medicare and Medicaid

On Thursday, Senators Bill Cassidy (R-LA), Tom Carper (D-DE), John Cornyn (R-TX), Mark Warner (D-VA), Tim Scott (R-SC), and Bob Menendez (D-NJ), members of the Senate Duals Working Group, introduced the Delivering Unified Access to Lifesaving Services (DUALS) Act of 2024 to improve coverage for individuals jointly enrolled in Medicare and Medicaid, also known as dual eligibles. The legislation would require each state, with support from the Centers for Medicare & Medicaid Services (CMS), to select, develop, and implement a comprehensive, integrated health plan for dual-eligible beneficiaries. Additionally, it would reduce “look-alike” plans that target dual eligible beneficiaries for enrollment, create a single appeals process instead of the current Medicare and Medicaid appeals process, and reduce third-party marketing organization incentives to target beneficiaries. The bill would also expand Program of All-Inclusive Care for the Elderly (PACE) coverage nationwide by requiring every state to allow PACE programs to be established, allow enrollment in a PACE program at any time in the month, and expand PACE coverage to individuals under the age of 55. Read the press release here and the bill here.

Sens. Cornyn, Bennet Introduce Bill to Lower Prescription Drug Costs for Seniors

On Thursday, Senators John Cornyn (R-TX) and Michael Bennet (D-CO) today introduced the Increasing Access to Biosimilars Act, which would lower prescription drug costs for seniors by promoting competition and encouraging physicians to prescribe biosimilar medications with lower out-of-pocket costs. legislation would direct the U.S. Department of Health and Human Services to establish a shared savings demonstration project to increase access to biosimilars in the Medicare Part B program. Read the press release here and the bill here.

Sens. Whitehouse, Barrasso, Kilmer, Smith, Reps. Gallagher, DelBene Introduce Bipartisan, Bicameral Legislation to Expand Access to Accountable Care Organizations and Coordinated Health Care

On Thursday, Senators Sheldon Whitehouse (D-RI), and John Barrasso (R-WY), and Reps. Derek Kilmer (D-WA), Adrian Smith (R-NE), Mike Gallagher (R-WI), and Suzan DelBene (D-WA) today introduced the ACO Assignment Improvement Act, which would expand Medicare Accountable Care Organizations (ACOs) to include nurse practitioners, physician assistants, and clinical nurse specialists. Currently, Medicare beneficiaries who want to participate meet with a primary care physician, who will assign them to an ACO. The ACO Assignment Improvement Act will respect the longstanding relationships patients have with their primary care providers and allow for ACO assignment based on primary care visits with nurse practitioners, physician assistants, and clinical nurse specialists. Read the press release here and the bill here.

Senators Smith, Stabenow, Reps. Tonko, Fitzpatrick, Trone Reintroduce Legislation Expanding Mental Health Care Access, Increase Medicaid Reimbursement Rate

On Thursday, Senators Tina Smith (D-MN), and Debbie Stabenow (D-MI), announced reintroduced legislation to expand access to mental health services for low-income families and children, the elderly, and people living with disabilities. The Medicaid Bump Act would increase the federal reimbursement rate for mental and behavioral health care services under Medicaid, which covers one-fifth of all Americans with mental health disorders. A House companion bill was introduced by Reps. Paul Tonko (D-NY), Brian Fitzpatrick (R-PA), and David Trone (D-MD). Read the press release here and the bill here.

Reps. Wenstrup & Schneider Introduce Bipartisan Bill to Make Telehealth & Primary Care Visits More Affordable

On Wednesday, Reps. Brad Wenstrup (R-OH) and Brad Schneider (D-IL) introduced the Bipartisan Primary and Virtual Care Affordability Act to enhance the affordability of primary care and telehealth for patients with High-Deductible Health Plans (HDHPs). The legislation would allow HDHPs to waive the deductible for primary care and telehealth. Read the press release here and the bill here.

Reps. Wenstrup and Blumenauer Release Bipartisan Draft to Expand Access to Health Care at Home

On Tuesday, Reps. Wenstrup and Blumenauer released a bipartisan draft of the Hospital Inpatient Services Modernization Act, which would reauthorize the Acute Hospital Care at Home waiver flexibilities, currently set to expire December 31, 2024, through September 30, 2027. Acute care delivery at home allows for in-home, hospital-quality medical care to be administered to interested patients with qualifying acute conditions instead of admission as an inpatient at a hospital. Read the draft here.

Rep. Carter, Colleagues Introduces Bipartisan Permanent Telehealth for Seniors Bill

On Tuesday, Reps. Buddy Carter (R-GA), Lisa Blunt Rochester (D-DE), Greg Steube (R-FL), Terri Sewell (D-AL), Mariannette Miller-Meeks (R-IA), Jefferson Van Drew (R-NJ), and Joe Morelle (D-NY) introduced the Telehealth Modernization Act of 2024 to extend telehealth flexibilities for Medicare beneficiaries permanently. The bill would ensure permanent access to telehealth services for Medicare beneficiaries and extends these flexibilities to federally qualified health centers and rural health clinics. Read the press release here and the bill here.

Reps. Trahan, Fitzpatrick Reintroduce Bipartisan Legislation to Keep Assisted Living Facilities Open

Late last week, Reps. Lori Trahan (D-MA) and Brian Fitzpatrick (R-PA) reintroduced the Safeguarding Elderly Needs for Infrastructure and Occupational Resources (SENIOR) Act. The SENIOR Act directs the U.S. Department of Labor and Health Resources and Services Administration (HRSA) to establish new and expand existing workforce development programs to strengthen the pipeline and incentivize the development of a stronger geriatric workforce. Additionally, the bill establishes a “Senior Care Cost Reduction Program” that allows States to administer monthly cost reduction amounts to low-income seniors to allow them to access assisted living facilities as opposed to nursing homes. Read the press release here and the bill here.

Reps. Barragán and Burgess Introduce National Patient Safety Board Act

Late last week, Reps. Nanette Barragán (D-CA) and Michael Burgess (R-TX), reintroduced the National Patient Safety Board Act. The NPSB will be a nonpunitive, collaborative, and independent board within the Department of Health and Human Services, and will interface with the Department of Health and Human Services agencies, the Department of Veterans Affairs, and private entities. The NPSB would identify harm, conduct studies, and recommend solutions. Read the press release here and the bill here.

Executive Branch:

HHS and CMS Responds to Change Health Care Cyber Attack

On Sunday, the Department of Health and Human Services (HHS) told health care leaders that the agency is urging UnitedHealth Group to take responsibility for the impact of a massive cyberattack that has delayed provider payments. HHS Secretary Xavier Becerra wrote to the health care industry, defending HHS’ actions following the attack and stated officials are “asking private sector leaders across the health care industry, especially other payers, to meet the moment.” On Saturday, HHS also widened the types of providers that can receive advance payment to help them. In his letter, Becerra called on UnitedHealth to ensure expedited delivery of funds to providers, communicate more frequently, and provide Medicaid agencies with a list of impacted providers. He also turned to insurers, calling on them to make interim payments to providers, particularly Medicaid providers, and ease their administrative burden. Impacted providers can apply for 30 days of relief that must be repaid. Read the letter here. Read the CMS statement here and the fact sheet here.

On Tuesday, HHS Secretary Xavier Becerra and Deputy Secretary Andrea Palm led a convening of health care community leaders, joined by White House Domestic Policy Advisor Neera Tanden, White House Deputy National Security Advisor (DNSA) for Cyber and Emerging Technologies Anne Neuberger, and others from the federal government, to discuss concrete actions to mitigate harms to patients and providers caused by the cyberattack on Change Healthcare. Read the HHS readout here and the CMS statement here.

Separately, on Wednesday, the HHS Office of Civil Rights (OCR) announced a probe into whether the Change Healthcare hack resulted in the disclosure of private patient information. The investigation will also center on whether Change Healthcare and its owner, UnitedHealth Group, were in compliance with HIPPA health privacy laws. Melanie Fontes Rainer, director of the HHS Office for Civil Rights, said in a letter Wednesday, "Given the unprecedented magnitude of this cyberattack, and in the best interest of patients and health care providers, OCR is initiating an investigation into this incident." Read the letter here.

President Biden Releases Fiscal Year 2025 Budget Proposal

$47.9 billion for the National Institutes of Health, up from $47.6 billion under fiscal 2023 law. This includes flat funding for the Advanced Research Projects Agency for Health, opioid and pain research, HIV research, and developing a universal flu vaccine.
$8.5 billion in discretionary spending for the Centers for Disease Control and Prevention, a 1 percent increase from 2023 levels.
$3.8 billion for the Administration for Strategic Preparedness and Response, up from $3.6 billion.
The Centers for Medicare and Medicaid Services would receive an increase under the request, with a proposed 5% bump for CMS Program Management to $4.3 billion and a $48 million increase to $941 million for program integrity efforts.

Read the White House fact sheet on healthcare provision in the budget proposal here.

FDA Approves Wegovy to Reduce Risk of Serious Heart Problems

On Friday, the FDA approved Novo Nordisk's Wegovy for the prevention of cardiovascular death, heart attack, and stroke in patients who are overweight and have cardiovascular disease. In a multi-national study of 17,600 patients, 6.5 percent of trial participants who received Wegovy suffered cardiovascular deaths, heart attacks, or strokes compared to 8 percent in the placebo group. The decision could broaden access to the drug through insurance and Medicare, which does not cover drugs for obesity and will also likely raise concerns around government spending as Medicare access to the drug widens. Read the FDA press release here.

FDA Approves First Drug to Treat Common, Lethal Liver Disease

On Thursday, Madrigal Pharmaceuticals Inc. a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), a potentially deadly liver disease that affects millions worldwide, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Rezdiffra (resmetirom). The drug price is listed at $47,400 a year. Read the press release here.

CONGRESSIONAL HEARINGS & EVENTS

House & Senate Hearings and Markups:

House:

House Ways and Means Committee – Field Hearing (Denton, Texas)

“Access to Health Care in America: Ensuring Resilient Emergency Medical Care”

Monday, March 18, at 2:00 PM (Central Standard Time)

House Appropriations Committee, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies - Hearing

“Fiscal Year 2025 Budget Request for the Department of Health and Human Services”

Wednesday, March 20, at 10:00 AM

House Ways and Means Committee – Hearing

“Hearing with Health and Human Services Secretary Becerra”

Wednesday, March 20, at 2:00 PM

House Energy and Commerce, Subcommittee on Health – Hearing

“Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.”

Thursday, March 21, at 10:00 AM

House Committee on Veterans' Affairs, Subcommittee on Health – Hearing

“H.R. 3584, Veterans Care Act; H.R. 3644, Act for Veterans Act; H.R. 3649, Veterans National Traumatic Brain Injury Treatment Act; H.R. 4424, Vietnam Veterans Liver Fluke Cancer Study Act; H.R. 5530, VA Emergency Transportation Access Act; H.R. 6324, FY24 VA Major Medical Facility Authorization Act; H.R. 6373, Veterans STAND Act; H.R. 7347, To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to report on whether the Secretary will include certain psychedelic drugs in the formulary of the Department of Veterans Affairs; H.R. 3225, BUILD for Veterans Act; H.R. 5794, VA Peer Review Neutrality Act; H.R. 3303 Maternal Health for Veterans Act (Rep. Underwood); and H.R. 5247, Expedited Hiring for VA Trained Psychiatrists Act of 2023.”

Thursday, March 21, at 2:00 PM

Select Subcommittee on the Coronavirus Pandemic – Hearing

“Assessing America’s Vaccine Safety Systems, Part 2”

Thursday, March 21, at 2:00 PM

Senate:

Senate Judiciary Committee – Hearing

“The Continued Assault on Reproductive Freedoms in a Post-Dobbs America”

Wednesday, March 20, at 2:30 PM