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Congressional:
Senate Passes 'Patent Thicket' Legislation
On Thursday, the Senate approved, by unanimous consent, the patent thicket portion of the Affordable Prescriptions for Patients Act of 2023 (S. 150). The bill seeks to limit the number of patents a drugmaker can use in a patent infringement lawsuit against a company trying to make a biosimilar version of their product. The bill would save $1.8 billion in federal spending over the next ten years, with the savings going into the Medicare Improvement Fund. Read the bill summary here.
House Appropriators Advance HHS Spending Bill
On Wednesday, the House Appropriations Committee held a markup on the Department of Health and Human Services spending bill, advancing it on a 31-25 party-line vote. The Labor-HHS-Education bill would provide $107 billion for the Health and Human Services Department, a decrease of $8.5 billion, or 7%, from the fiscal 2024 enacted level. The measure includes cuts for the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the Health Resources and Services Administration (HRSA). The Substance Abuse and Mental Health Services Administration (SAMHSA) would see an increase. The HHS funding bill would also provide flat funding of $48 billion for the National Institutes of Health (NIH) and calls for restructuring the agency's 27 centers into 15 sections. Rep. Rosa DeLauro (D-CT), the top Democratic appropriator, stated Democrats would not settle for less than a 1% increase in domestic spending bills and parity with any added defense spending. Read the bill report here and the full committee markup summary here.
Senate Appropriators Approve FDA Spending Bill
On Thursday, the Senate Appropriations Committee approved 27-0 a draft bill to fund the Food and Drug Administration (FDA), one day after the House approved its own measure. The Senate Agriculture spending measure would fund the FDA at $6.9 billion in fiscal 2025, which includes $3.5 in discretionary funding, a $22 million increase over fiscal 2024. The House Appropriations Committee version approved Wednesday evening would fund the agency at $6.8 billion, including $3.5 billion in direct appropriations. The Senate bill includes an increase of $15 million for food safety at the FDA. Read the bill text here, bill report here, and summary report here.
Senate Special Committee on Aging Holds Hearing on Health Care Transparency
On Thursday, the Senate Special Committee on Aging held a hearing to examine how to cut costs and empower patients through health care transparency. During the hearing, Chair Bob Casey (D-PA) introduced his Capping Prescription Drug Costs Act with nine colleagues, which would extend prescription drug cost savings to the commercial health care market by capping out-of-pocket costs at $2,000 annually for individuals and $4,000 annually for families. Ranking Member Mike Braun (R-IN) also announced his plans to release a new report highlighting the need for Congress to enact additional transparency across the health care supply chain. Read Mehlman’s hearing summary here.
Senate HELP Committee Holds Hearing on Medical Debt
On Thursday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on reducing medical debt, with senators split along party lines on the solution. Democrats pushed for debt cancellation to help patients maintain the care they need, pointing to evidence that financial stress can exacerbate health problems. Ranking member Bill Cassidy (R-LA) and other Republicans on the panel advocated for redefining government policies to ensure that hospitals use subsidies for patient care. Cassidy stated, “A one-time cancellation of medical debt is not a solution. It is a Band-Aid approach to a one-time problem that’s gonna come back.” There was bipartisan support for improving health care price transparency, but Sen. Tina Smith (D-MN) and other Democrats expressed doubt that transparency alone would fix the larger issue of medical debt. Read more on the hearing here.
House GOP Leadership Demands Answers from Agencies Post-Chevron
On Wednesday, House Majority Leader Steve Scalise (R-LA) and House Oversight Committee Chair James Comer (R-KY) released statements following the Supreme Court overturning of the Chevron deference last month, demanding dozens of federal agencies review “overreaching” regulations. In his statement, Scalise stated, “We intend to ensure agencies are held accountable following the court’s ruling and observe the proper checks on their power.” Comer and other committee chairs wrote to more than two dozen federal agencies, including HHS, the Justice Department, the EPA, and the Departments of Labor, Energy, Education, and Homeland Security. The Republican leaders asked the agencies to provide a list of rules and adjudications that could be impacted by the decision if challenged and a list of pending challenges, as well as all pending rules and adjudications that could have been eligible for Chevron deference before the decision, by the end of the month. Read Scalise’s statement here and Comer’s statement and letters here.
Notable Bills Introduced:
Reps. Burgess, Cárdenas, Griffith, Gonzales Introduce the Physician Led and Rural Access to Quality Care Act
On Thursday, Reps. Michael Burgess (R-TX), Tony Cárdenas (D-CA), Morgan Griffith (R-VA), and Vicente Gonzalez (D-TX) introduced the Physician Led and Rural Access to Quality Care Act. The bipartisan legislation would increase access to care for American patients in rural areas across Texas and the United States. The bill would also allow certain exemptions to rules for physician-owned hospitals in rural areas and remove a ban that prevents existing physician-owned hospitals from expanding. Read the press release here and the bill here.
Rep. Carey & Colleagues Introduce Bill to Expand Emergency Medical Treatment Options for Seniors
On Wednesday, Reps. Mike Carey (R-OH), Lloyd Doggett (D-TX), Carol Miller (R-WV), Pat Ryan (D-NY), and Debbie Dingell (D-MI) introduced the bipartisan Improving Access to Emergency Medical Services for Seniors Act. The bill would allow seniors on Medicare to receive at-home emergency medical services to treat minor medical incidents. Read the press release here and the bill here.
Rep. McMorris Rodgers Introduces the MIRACLE Act to Improve Lives of Drug-Dependent Newborns
On Tuesday, Rep. Cathy McMorris Rodgers (R-WA) introduced H.R. 8905, the Maddie’s Infant Recovery and Children’s Legislative Emergency (MIRACLE) Act, to better understand the prevalence of Neonatal Abstinence Syndrome (NAS), a group of conditions that can occur when newborns withdraw from certain substances, including opioids, that they were exposed to before birth. Specifically, the MIRACLE Act would require the Secretary of Health and Human Services (HHS) to conduct a study on the prevalence of NAS that Congress and states like Washington can use to address the root cause of the issue. Read the press release here and the bill here.
Executive Branch:
HHS Releases CY 2025 Physician Payment Proposed Rule
On Wednesday, the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced new policies in the calendar year (CY) 2025 Medicare Physician Fee Schedule (PFS) proposed rule. The proposal includes a 2.8% cut to physician Medicare reimbursements for 2025. The proposed rule would also strengthen primary care, expand access to behavioral health, oral health, and caregiver training services, maintain telehealth flexibilities, and expand access to screening for colorectal cancer and vaccinations for hepatitis B. Read the press release here and the fact sheet here.
HHS Releases CY 2025 Hospital Outpatient Prospective Payment System (OPPS) And Ambulatory Surgical Center (ASC) Proposed Rule
On Tuesday, the Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced new policies that aim to reduce maternal mortality and morbidity. The Calendar Year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule proposes a 2.6% increase for hospitals’ outpatient services and ambulatory surgical centers. CMS is also proposing policies that would increase access to care and advance health equity including: proposing exceptions to the Medicaid clinic services “four walls” requirement; codifying the requirement of 12 months of continuous eligibility for children enrolled in Medicaid and CHIP; proposing an add-on payment to the All-Inclusive Rate (AIR) for certain Indian Health Services (IHS) and tribal facilities to increase access to certain high-cost drugs; expanding the hospital outpatient, ASC and rural emergency hospital quality program measure sets to include equity measures consistent with other provider types; and eliminating barriers for enrolling and maintaining Medicare coverage for individuals returning to the community from incarceration. Read the press release here.
HHS ONC Proposes Rule to Enable Data Sharing in A Public Health Emergency
On Wednesday, the Department of Health and Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC), released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule for public comment. The HTI-2 proposed rule reflects ONC’s efforts to advance interoperability and improve information sharing among patients, providers, payers, and public health authorities. The HTI-2 proposed rule has two sets of new certification criteria designed to enable health IT for public health as well as health IT for payers to be certified under the ONC Health IT Certification Program. Read the press release here.
FTC Releases Preliminary Report on PBM Role in Raising Drug Costs
On Tuesday, the Federal Trade Commission (FTC) published a staff report detailing preliminary findings from the Federal Trade Commission’s study into the six largest pharmacy benefit managers (PBM), which the agency launched in June 2022. The report stated that PBMs’ integration with health insurers and specialty and retail pharmacies means they “can now exercise significant power over Americans’ access to drugs and the prices they pay.” FTC Chair Lina Khan stated, “The FTC’s interim report lays out how dominant pharmacy benefit managers can hike the cost of drugs—including overcharging patients for cancer drugs,” and “squeeze independent pharmacies that many Americans—especially those in rural communities—depend on for essential care.” Read the report here.
FTC Preparing Suit Against PBMs Over Insulin & Drug Rebates
On Wednesday, the Federal Trade Commission announced it is drawing up a lawsuit against the three largest pharmacy benefit managers, CVS Health, Cigna Group, and UnitedHealth Group, over their use of rebates for insulin and other drugs. The lawsuit will claim the companies illegally maximize profits by steering patients toward high-cost drugs. However, the agency’s five commissioners must vote on the lawsuit before it can be filed. An interim FTC report released Tuesday (see story below) found PBMs often “steer” patients to their own dispensaries to “advantage their own pharmacies while excluding rivals.” The lawsuit could be filed as soon as this month, but no final decision has been made.
FDA Updates Draft Guidance on Misinformation on Medical Devices and Prescription Drugs
On Monday, the Food and Drug Administration (FDA) released a revised draft guidance allowing prescription drug makers and medical device manufacturers to directly call out and correct social media influencers who spread online misinformation about their products. The guidance encourages companies to directly respond to internet-based misinformation when that misinformation is disseminated by an independent or third party. The agency says this could include a celebrity, health care provider, or influencer not acting on behalf of the company. The draft guidance revises the guidance for industry issued in June 2014. Read the draft guidance here.
Legal & Other:
Judge Tosses Boehringer Bid to Block Biden Drug Price Plan
Last week, a federal judge rejected Boehringer Ingelheim’s attempt to block the Medicare Drug Price Negotiation Program. Chief Judge Michael P. Shea of the US District Court for the District of Connecticut denied all of Boehringer Ingelheim Pharmaceuitcals Inc. claims that the Biden administration’s program is unconstitutional. The manufacturer argued the program violates the First Amendment prohibition on compelled speech, Fifth Amendment due process and takings clauses, Eighth Amendment excessive fines clause, the Administrative Procedure Act, and the unconstitutional conditions doctrine. Shea wrote in his opinion, “I find that BI’s participation in Medicare and Medicaid is voluntary, even if BI has a considerable economic incentive to participate.” The case is Boehringer Ingelheim Pharmaceuticals, Inc. v. United States Department of Health and Human Services. Read more on the case here.
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