Health Care Watch: August 12, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from August 3 – August 11. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On August 2, a bipartisan group of 80 members of Congress, led by Reps. Jack Bergman (R-MI) and Lou Correa (D-CA) sent a letter to President Biden and Food & Drug Administration (FDA) Commissioner Dr. Robert Califf urging the Administration to approve MDMA-assisted therapy to help address the veteran suicide epidemic.
The House returns from its August recess on September 9.
Senate
On August 2, Health, Education, Labor & Pensions (HELP) Committee Chairman Bernie Sanders (I-VT)introduced the Long COVID Research Moonshot Act of 2024. The legislation would provide $1 billion in mandatory funding per year for 10 years to the National Institutes of Health (NIH) to support long COVID research.
On August 2, Judiciary Committee Chairman Dick Durbin (D-IL) and HELP Committee Ranking Member Bill Cassidy (R-LA) introduced the Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act which aims to promote competition by removing barriers to FDA approval for lower-cost generic drugs. TheREMEDY Act would narrow the scope of the 30-month stay by requiring the brand-name manufacturer, upon FDA approval of its drug, to identify which single patent would receive the 30-month stay if challenged.
On August 6, Finance Committee Ranking Member Mike Crapo (R-ID), House Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA), and House Ways & Means Committee Chairman Jason Smith (R-MO) sent a letter to Government Accountability Office (GAO) Comptroller General Gene Dodaro asking the office to review the legality of the Medicare Part D Premium Stabilization demonstration recently announced by the Centers for Medicare & Medicaid Services (CMS). The lawmakers also ask GAO to investigate the budgetary analysis CMS performed when developing the program as well as the demonstration’s projected cost and determine whether it meets budget neutrality requirements.
On August 8, Finance Committee Chairman Ron Wyden (D-OR) and Sens. Cynthia Lummis (R-WY), Sherrod Brown (D-OH), Susan Collins (R-ME), and Bob Casey (D-PA) released bipartisan legislation that aims to help Customs and Border Protection (CBP) stop the flow of illicit goods, including fentanyl, counterfeits, and products made with forced labor, into the country by tightening import requirements for low-value packages. Specifically, the Fighting Illicit Goods, Helping Trustworthy Importers, and Netting Gains (FIGHTING) for America Act would tighten the rules for de minimis entry and help CBP more effectively stop unlawful imports.
The Senate returns from its August recess on September 9.
REGULATORY UPDATE
On August 1, FDA approved TECELRA (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA authorized companion diagnostic devices.
On August 5, the Health Resources and Services Administration (HRSA) released new data finding that over 31 million total patients were served at HRSA-funded health centers in 2023—an increase of 2.7 million since 2020. Additionally, HRSA found that Health Centers are now serving one in eight children across the country, more than 9.7 million patients in rural areas, over 6.4 million patients who live in or near public housing, and over 1.4 million people experiencing homelessness.
On August 5, FDA’s Center for Devices and Radiological Health (CDRH) released a discussion paper on health equity for medical devices. The discussion paper aims to obtain feedback regarding ways to help ensure that all patients have timely access to safe, effective, and high-quality medical devices and safe radiation-emitting products. The paper requests feedback on possible considerations that may help inform the design of a clinical study that adequately reflects the intended use population for a particular medical device.
On August 7, CMS issued a final procedural notice outlining the Transitional Coverage for Emerging Technologies (TCET) Pathway. The new TCET pathway, for certain FDA-designated Breakthrough Devices, increases the number of national coverage determinations (NCDs) that CMS will conduct per year and aims to support improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population. CMS anticipates accepting up to five TCET candidates per year and, for technologies accepted into and continuing in the TCET pathway, CMS’ goal is to finalize an NCD within six months after FDA market authorization. A fact sheet detailing the TCET pathway can be found here.
On August 7, HRSA, awarded nearly $9 million to 18 HRSA-funded health centers to improve access to cancer screenings in underserved communities. Health centers will be able to partner directly with National Cancer Institute-Designated Cancer Centers to expedite patient access to cancer care and treatment. A list of all awardscan be found here.
On August 7, FDA approved ZURNAI, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older.
On August 7, CDC released a statement alerting doctors of a deadly new strain of mpox spreading through parts of Africa. The CDC alert came after World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said he would convene an emergency committee to determine if the outbreak amounts to a public health emergency of international concern.
On August 8, the Department of Health & Human Services (HHS) released a proposed rule to amend and update its Health and Human Services Acquisition Regulation (HHSAR). The proposed rule would implement requirements to procure health information technology (health IT) that meets standards and implementation specifications adopted by the Office of the National Coordinator for Health Information Technology (ONC) in the following parts: Acquisition of Information Technology and Solicitation Provisions and Contract Clauses. HHS stated that the proposed rule aims to help create clear guidelines for health tech, reduce burden for developers, and make it easier to share data across systems. Comments are due by October 8.
On August 8, HHS released division-specific language access plans in an effort to make sure that individuals with limited English proficiency (LEP) and people with disabilities have greater access to health care services. HHS stated that this effort aims to exemplify the Department’s commitment to providing accessible, culturally and linguistically competent, and comprehensive health care and human services.
On August 8, CDC released updated guidance for contraceptive prescribing and use. The new recommendations cover many topics including contraceptive options for people with kidney disease and guidance for new birth control methods.
On August 8, CMS released guidance on how state Medicaid agencies must ensure that enrollees have access to family planning services. This bulletin highlights state obligations, provides strategies to enhance access to contraception, provides guidance on confidentiality requirements for those seeking family planning services, and shares recommendations about ways to measure quality in delivering family planning services.
On August 9, FDA rejected Lykos Therapeutics’ application for a new drug application for midomafetamine capsules for patients suffering from post-traumatic stress disorder (PTSD). FDA requested that Lykos conduct an additional Phase 3 trial to further study the safety and efficacy of MDMA. Lykos stated that it plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency's recommendations for a resubmission seeking regulatory approval for midomafetamine capsules.
On August 9, FDA approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who weigh at least 30 kilograms (about 66 pounds). The approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection.
WHITE HOUSE
On August 6, Vice President Kamala Harris named Minnesota Governor Tim Walz (D) as her running mate for the 2024 Presidential Election. Gov. Walz served as a U.S. Representative for Minnesota's First Congressional District for 12 years and became Minnesota’s Governor in 2018.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program (CMS-2434); Final Rule; 3/22/24
Administrative Simplification: Modifications to NCPDP Retail Pharmacy Standards (CMS-0056); Final Rule; 6/27/24
HHS Notice of Benefit and Payment Parameters for 2026 (CMS-9888); Proposed Rule; 7/17/24
Amendments to Rules Governing Organ Procurement Organizations (CMS-3409); Proposed Rule; 8/8/24
FDA
Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability; Notice; 7/9/24
Conducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Stakeholders; Availability (2023-814); Notice; 7/25/24
Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availability; Notice; 7/25/24
OASH
Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity Act; 8/6/24; Proposed Rule
Public Health Service Policies on Research Misconduct; Final Rule; 8/7/24
REPORTS
Office of Inspector General (OIG)
On August 5, OIG released a report examining NIH health administered superfund appropriations during fiscal year (FY) 2023. OIG found that, during FY 2023, NIH administered Superfund appropriations in accordance with applicable Federal requirements. Specifically, NIH obligated and disbursed Superfund appropriations in accordance with Federal requirements and in similar proportions to prior years. In addition, the Institute’s monitoring of Superfund grants generally ensured that recipients met requirements for financial, performance, and audit reporting.
On August 5, OIG released a report examining CDC oversight and assistance in implementing a COVID-19 vaccine confidence strategy. OIG found that CDC provided oversight and assistance to the recipients in developing and implementing a vaccine confidence strategy by utilizing recipient data, conducting periodic outreach through webinars and technical assistance calls, among other things. Of the nearly $244 million in funding to the 64 recipients, more than $116 million, or nearly 48%, had been expended as of March 4, 2024. Based on the recipients’ responses to the OIG survey, OIG identified challenges or barriers that the recipients faced in developing and implementing a vaccine confidence strategy. Some of those challenges or barriers included: 1) language and location barriers; 2) lengthy contract processes; 3) COVID-19 fatigue; and 4) vaccine mistrust or hesitancy, which impacted recipients’ expending of award funds. OIG made no recommendations, however, CDC indicated that it would use the suggestions and feedback from the recipients’ responses to the OIG survey to improve the development and oversight of its Vaccinate with Confidence strategic framework.
On August 7, OIG released a report examining opioid treatment programs (OTPs) in Washington state. OIG found that Washington did not ensure that OTPs fully complied with Federal and State requirements for OTP services they provided. Of the 100 sample items, 4 met the requirements, but 96 sample items did not meet the requirements. Additionally, OIG found that OTPs did not adequately document enrollee admissions, treatment plans, opioid treatment services, the results of drug screens, checks of Washington’s prescription drug monitoring program (PDMP) prescription data, and enrollee assessments. OIG also found that OTPs did not provide take-home medications in accordance with Federal and State requirements. OIG recommends that that the Washington State Health Care Authority work with its contracted managed care organizations and the Department of Health to ensure that OTPs comply with Federal and State requirements for providing and documenting OTP services, including ensuring that OTPs: 1) adequately document enrollee admissions, treatment plans, opioid treatment services, the results of drug screens, checks of Washington PDMP prescription data, and enrollee assessments; and 2) provide take-home medications in accordance with Federal and State requirements.
Government Accountability Office (GAO)
On August 8, GAO released a report examining Medicare coverage of immunosuppressant drugs for patients undergoing a kidney transplant. GAO stated that the benefit, which took effect on January 1, 2023, is limited to immunosuppressive drugs, and does not cover other Medicare services. Additionally, GAO stated that patients enrolled in the benefit, attested to having no other coverage for immunosuppressive drugs and paid monthly premiums and cost sharing, including 20% of the Medicare-approved amount for the drugs. GAO found that there were 104 patients enrolled in the benefit as of February 2024 and another 146 patients enrolled and then disenrolled in the benefit from January 2023 through February 2024 due to various reasons, such as nonpayment of premiums. GAO made no recommendations and stated that CMS' efforts at the time of GAO's review are consistent with agency statements that CMS will monitor compliance with the benefit's eligibility requirements and address any concerns.
UPCOMING HEARINGS
Senate
HELP Committee
September 12; TBD
Testimony from Ralph De La Torre, CEO, Steward Health
September 24; 10:00 AM; SD-562
ADDITIONAL POLICY NEWS
On August 8, Ohio Federal Judge Michael Newman threw out the U.S. Chamber of Commerce's challenge to the Medicare drug price negotiations, stating that the lawsuit was filed in an improper venue and that other plaintiffs in the case lacked standing. Judge Newman ruled that the Dayton Area Chamber of Commerce, Ohio Chamber of Commerce and Michigan Chamber of Commerce had no standing to sue because their claims did not relate specifically to the state and local interests they were meant to protect.