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Congressional:
Senate Passes Maternal and Child Health Stillbirth Prevention Act, Heads to President
On Tuesday, the Senate passed H.R. 4581, the Maternal and Child Health Stillbirth Prevention Act, via unanimous consent. The bill expands the scope of the Maternal and Child Health Services Block Grant to include research and activities to prevent stillbirths. The House passed the bill in May, and it now heads to the president, where it is expected to be signed into law.
House Energy and Commerce Committee Advances 13 Healthcare Bills
On Wednesday, the House Energy and Commerce Committee held a markup on 13 healthcare bills covering a wide range of topics. The bills included improving Medicaid program integrity, creating means for improved stem cell and autism research, raising awareness of stillbirths, supporting living organ donors, and improving seniors' access to healthcare. All 13 bills passed out of Committee on a bipartisan basis. There was no telehealth extension legislation included in the markup. Chair Rodgers stated that lawmakers are still working on a “fully paid for” telehealth package, with additions related to diabetes and cardiac care, and she’s hopeful the committee will advance the package before the August recess. Read Mehlman’s markup summary here.
House Energy and Commerce Health Subcommittee Holds Hearing on CMMI
On Thursday, the House Energy and Commerce Subcommittee on Health held a hearing to examine the state of the Center for Medicare and Medicaid Innovation (CMMI) and the transition toward value-based care. CMMI Deputy Administrator and Director Liz Fowler was the sole witness at the hearing. The hearing centered on CMS’ transition to value-based care, which CMMI has been trying to implement. Fowler pushed back against GOP accusations that CMMI's operations are too expensive, stating that CMS heeds providers’ advice and reducing spending is CMMI’s “statutory mission.” Republicans also raised concerns that the center is shifting away from saving money and only to improving the quality of care. Full Committee Chair Cathy McMorris Rodgers (R-WA) stated, “It seems there’s an explicit shift and focus away from trying to reduce spending.” Fowler stated that as most models are voluntary, it "has affected our ability to generate savings," and providers can choose to drop out of models if they are not doing well, which "has led to risk selection." Read Fowler’s testimony here.
House Committee Outlines 2025 FDA Budget Request
On Monday, House Republicans proposed $3.5 billion in discretionary funding for the Food and Drug Administration (FDA) for fiscal 2025, roughly $300 million less than the Biden administration requested. The proposal includes $6.75 billion in total program funding: $3.5 billion in discretionary funding, roughly $22 million below 2024 funding levels, and $3.25 billion in user fees. The House Agriculture, Rural Development, and FDA subcommittee held a markup on the overall Agriculture-FDA appropriations bill on Tuesday, with the full committee markup on the bill scheduled for July 10. Read the press release and bill here.
Sen. Sanders Announces HELP Committee Vote to Subpoena Novo Nordisk Inc. President
On Tuesday, Senate Health, Education, Labor and Pensions (HELP) Chairman Bernie Sanders (I-VT) announced that the committee will vote to subpoena the President of Novo Nordisk Inc., Doug Langa, to provide testimony about why his company charges higher prices for Ozempic and Wegovy in the U.S. compared to other countries on Tuesday, June 18. Sanders stated he plans to hold an executive session on the topic on Wednesday, July 10. Read the press release here.
MACPAC Urges Enhanced Transparency, Care Coordination
On Tuesday, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its June report to Congress. The report recommended measures to enhance the transparency of the program’s financing, improve care coordination for dual eligible beneficiaries, and optimize state Medicaid agency contracts. MACPAC recommended that Congress amend the Medicaid statute to require states to submit annual, comprehensive reports on their Medicaid financing methods and the amounts of the non-federal share of Medicaid spending acquired from all providers. The report stated the increased transparency would enable policymakers to analyze the full scope of net Medicaid payments and provide a clearer understanding of how providers are paid under alternative financing mechanisms. Read the full report here.
MedPAC Report to Congress Highlights Program Challenges, Goals
On Thursday, the Medicare Payment Advisory Commission (MedPAC) released its June report to Congress, addressing physician payment, Medicare Advantage, and artificial intelligence (AI), among other topics. In the report, MedPAC raised concerns about whether payments for clinicians will be sufficient in the future and suggested changing payment rates through the Medicare Economic Index, minus a percentage point. It also suggested continuing incentives for participating in alternative payment models for “a few more years.” The report also examined Medicare Advantage (MA) prior authorizations, finding that 95% of prior authorization requests were approved in Medicare Advantage in 2021, with denial rates between 3 and 12% among the largest MA plans. Regarding AI, the report stated it will weigh how Medicare should pay for software like AI, saying it will need to balance access and affordability. Read the report here.
Wyden Urges Biden Administration to Investigate UnitedHealth Group
On Thursday, June 13, Senate Finance Committee Chair Ron Wyden (D-OR) sent a letter to Federal Trade Commission (FTC) Chair Lina S. Khan and U.S. Securities and Exchange Commission (SEC) Chair Gary Gensler urging the agencies to hold UnitedHealth Group (UHG) accountable for "negligent cybersecurity practices." In the letter, Wyden stated, “This incident and the harm that it caused was, like so many other security breaches, completely preventable and the direct result of corporate negligence.” Wyden asked the FTC and SEC to investigate UHG’s “numerous cybersecurity and technology failures, to determine if any federal laws under your jurisdiction were broken, and, as appropriate, hold these senior officials accountable.” Read the press release and letter here.
House E&C Republicans Release Interim Staff Report on NIH Misconduct and Inadequate Oversight Involving Taxpayer-Funded MPXV Research
On Tuesday, the House Energy and Commerce Committee released a report titled “Interim Staff Report into Risky MPXV Experiment at the National Institute of Allergy and Infectious Diseases.” The report details the Committee’s investigation, which was launched following a 2022 Science magazine interview in which Dr. Bernard Moss of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) revealed that he was planning to insert segments of a lethal strain of MPXV (formerly known as “monkeypox”) into a more a transmissible strain of the virus. The report stated Officials from the Department of Health and Human Services (HHS) and the NIH “repeatedly obstructed and misled” a congressional inquiry into whether a federal researcher attempted to make a more potent mpox virus. Read the press release here and the report here.
Sen. Warren Calls for Bigger Crackdown on Insurers, Private Equity, and Big Pharma
On Monday, Sen. Elizabeth Warren (D-MA) wrote to the Department of Justice (DOJ), the Department of Health and Human Services (HHS), and the Federal Trade Commission (FTC), asking the three agencies to focus on a number of issues, including merger guidelines, potential insurer profit-shifting schemes, overpayments to private insurers in Medicare Advantage, and fighting patent abuse. The letter responds to the three agencies’ March 2024 cross-government inquiry, and highlights examples of abusive and anticompetitive behavior by companies in the health care industry. Read the letter here.
Notable Bills Introduced:
Sen. Marshall, Colleagues Reintroduce Bipartisan, Bicameral Prior Authorization Reform Bill
On Wednesday, Senators Roger Marshall (R-KS), Kyrsten Sinema (I-AZ), John Thune (R-SD), Sherrod Brown (D-OH), and Reps. Mike Kelly (R-PA), Suzan DelBene (D-WA), Larry Bucshon (R-IN), and Ami Bera (D-CA) reintroduced the Improving Seniors’ Timely Access to Care Act. The legislation would streamline the prior authorization process under Medicare Advantage (MA) by establishing an electronic prior authorization process for MA plans, including standardization for transactions and clinical attachments, and increase transparency around MA prior authorization requirements and its use, among other things. The legislation unanimously passed the House last Congress and was cosponsored by a majority of members in the Senate and House of Representatives. Read the press release here and the bill here.
Reps. Pettersen, Molinaro Introduce Bill to Bolster Health Care Access in Rural Communities
On Thursday, Reps Brittany Pettersen (D-CO) and Marc Molinaro (R-NY) introduced the Rural Health Preceptor Tax Fairness Act. The legislation would create a $1,000 non-refundable tax credit for licensed medical professionals who supervise medical and nursing students during their clinical rotations in rural areas, creating an increased financial incentive for medical professionals in rural communities to take on precepting duties. Read the press release here and the bill here.
Diabetes Caucus Co-Chairs Shaheen & Collins Introduce Bipartisan Bill to Strengthen Early Detection of Type 1 Diabetes, Improve Health Outcomes
On Wednesday, Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME), Co-Chairs of the U.S. Senate Diabetes Caucus, introduced the Strengthening Collective Resources for Encouraging Education Needed (SCREEN) for Type 1 Diabetes Act to improve early detection and screening for Type 1 diabetes. The legislation would conduct a public awareness campaign to increase awareness of the signs and symptoms of type 1 diabetes, as well as the importance of early detection and screening. Reps. Kim Schrier (D-WA) and John Joyce (R-PA) are leading a companion bill in the House of Representatives. Read the press release here and the bill here.
Rep. Letlow and Schrier Introduce the Newborn Essentials Support Toolkit (NEST) Act
On Wednesday, Reps. Julia Letlow (R-LA) and Kim Schrier (D-WA), along with co-sponsors Marrianette Miller-Meeks (R-IA) and Nanette Barragan (D-CA), introduced the Newborn Essentials Support Toolkit (NEST) Act. The bill seeks to establish a pilot program at the U.S. Department of Health and Human Services (HHS) to distribute newborn supply kits containing essential goods for new mothers and their infants. Through public-private partnerships, the legislation would direct HHS to work with community-based organizations, hospitals, and other organizations serving mothers and infants to distribute the supply kits. Read the press release here and the bill here.
Sens. Kelly, Braun Introduce Bipartisan, Bicameral Legislation to Support Senior Food Program
On Tuesday, Senators and Aging Committee members Mark Kelly (D-AZ) and Mike Braun (R-IN) introduced the Delivering for Rural Seniors Act, a bipartisan bill to support the delivery of the Commodity Supplemental Food Program (CSFP), commonly known as the “senior food box.” The Commodity Supplemental Food Program, administered by the U.S. Department of Agriculture, is a federal food assistance program that provides monthly food boxes to low-income seniors. However, seniors living in rural areas, seniors with disabilities, and those without reliable transportation often do not receive home delivery services from food banks participating in CSFP. The Delivering for Rural Seniors Act would address this gap by creating a pilot program to fund grants specifically for the delivery of CSFP to these underserved populations. Read the press release here and the bill here.
Executive Branch:
Vice President Harris Announces Proposal to Prohibit Medical Bills from Being Included on Credit Reports
On Tuesday, Vice President Harris and the Consumer Financial Protection Bureau’s (CFPB) Director Rohit Chopra announced a new action by the CFPB that would remove medical debt from credit reports of more than 15 million Americans, raising credit scores by an average of 20 points and leading to the approval of approximately 22,000 additional mortgages every year. Under the rule, credit reporting agencies can no longer use patients’ medical devices as collateral or repossess them. The proposal would work alongside the American Rescue Plan, a Covid-19-era law that allows local governments to partly cancel debt for their constituents. The effort would relieve up to $7 billion in loans for around 3 million Americans by 2026. The Vice President also called upon states, local governments, and health care providers to take additional actions to reduce the burden of medical debt for millions of Americans. Read the White House press release here.
CMS Releases 2023-2032 National Health Expenditure Projections
On Wednesday, the Centers for Medicare & Medicaid Services’ (CMS) Office of the Actuary released projections of National Health Expenditures (NHE) and health insurance enrollment for the years 2023-2032. The Office of the Actuary projects that over 2023-2032, average annual growth in NHE (5.6%) will outpace average annual growth in gross domestic product (GDP) (4.3%), resulting in an increase in the health spending share of GDP from 17.3% in 2022 to 19.7% in 2032. Of the payors, Medicare has the highest projected 10-year average spending growth rate at 7.4 percent, followed by private insurers at 5.6 percent and Medicaid at 5.2 percent. Out-of-pocket spending is projected to grow at an average rate of 4.7 percent between 2023 and 2032. During that time period, hospital and physician care spending is projected to grow at a rate of 5.7 and 5.6 percent, respectively. A 6 percent average annual growth in retail prescription drug spending was projected between 2023 and 2032. Read the press release and report here.
FDA Launches Emerging Drug Safety Technology Meeting (EDSTM) Program
On Monday, the Food and Drug Administration (FDA) announced a new drug center effort called the Emerging Drug Safety Technology Meeting (EDSTM) to understand how emerging artificial intelligence tools can be used to conduct pharmacovigilance. The EDSTM will have drug regulators meeting with academia, contract research organizations, vendors, and software developers to discuss the use of AI. Read more on the program here.
Advisory committee paves the way for Alzheimer's drug approval after delays
On Monday, a Food and Drug Administration (FDA) advisory committee unanimously voted to back approval of Eli Lilly's Alzheimer's drug donanemab. If approved, Eli Lilly's drug would be the second such drug on the market and compete with Eisai and Biogen's Alzheimer's drug, Leqembi. Both drugs remove toxic beta-amyloid plaques from people with early-onset Alzheimer's disease. Advisers on the Peripheral and Central Nervous System Drugs Advisory Committee voted 11-0 that donanemab's benefits outweigh its risks and also voted 11-0 that the drug is effective. The FDA is not required to follow the recommendation of the advisory committee but typically does.
Legal & Other:
Supreme Court to Revisit Contested Medicare Payment Ruling
On Monday, the Supreme Court announced they accepted a petition to review a decision on a case that decreased the extra Medicare payments received by hospitals that serve larger populations of low-income patients. More than 200 hospitals in more than 30 states led by Advocate Christ Medical Center in Illinois have asked the justices to overturn a lower court ruling that allows the Department of Health and Human Services (HHS) to reimburse a lower rate for treating a high proportion of low-income patients. The hospitals argued in a petition that HHS should base the Disproportionate Share Hospital (DSH) rate on Medicare patients who are enrolled in Social Security's Supplementary Security Income program, regardless of whether that patient is actually receiving cash benefits at the time of admission. The Biden administration has defended its position, which hinges on whether the patient is actually receiving cash payments at the time of hospital admission. Oral arguments in the Supreme Court will be held sometime in the October term.
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