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This week’s dose

This week, a bipartisan group of senators working on a gun violence prevention compromise announced a deal that has the backing of 10 Republican senators, enough to overcome a filibuster. We are awaiting the legislative text on the agreement, which should include certain health-related provisions. The Senate Committee on Health, Education, Labor, and Pensions (HELP) advanced its Food and Drug Administration (FDA) user fee reauthorization agenda, and the Senate Finance Committee unveiled the next element of his mental health program. In the House, the appropriations committee has begun reviewing its 12 annual spending bills for fiscal year 2023, with the goal of concluding all subcommittee and committee of the whole approvals before the July 4 recess. . The Supreme Court also ruled unanimously in favor of hospitals regarding the 340B drug pricing program payment reductions.

Congress

The FDA user fee bill is moving through the Senate. On June 14, the Senate HELP Committee held an executive session to consider Section 4348, the Food and Drug Administration Safety and Landmark Advancements Act. The bill reauthorizes the FDA’s user fee programs, which provide the agency with the funding necessary to conduct a number of activities, including product reviews, facilitating product development, inspections of facilities and product monitoring.

The HELP Committee approved Section 4348 by a vote of 13 to 9. Notably, Ranking Member Burr (R-NC) – who drafted the bill with Chairman Murray (D-WA) – voted against the bill of law due to the amendments adopted during the markup.

There are significant differences between S. 4348 and the FDA user fee bill passed by the House on June 8 (HR 7667) – notably, that the Senate bill includes the VALID (Verifying Accurate Leading-edge IVCT Development), which would give the FDA additional authorities to regulate in vitro diagnostics, including laboratory-developed tests, new regulations on cosmetics and dietary supplements, provisions impacting FDA regulations on infant formula and the re-importation of medicines.

Congress is working to quickly complete action on FDA user fee authorizations, as the FDA will begin to experience disruptions long before the authorization’s September 30 expiration date. Differences between the House and Senate bills will need to be reconciled before a bill can be finalized and reach the president’s desk for signing into law, which lawmakers hope to accomplish before the FDA has to begin send leave notices in early August.

The HELP committee also advanced four other bills during the June 14 executive session: The Health Care Act (S. 958) to Maximize Outcomes Through Better Investments in Lifesaving Equipment (MOBILE) ; the Retirement Enhancement and Savings Enhancement to Supplement Sound Nest Place Investments (RISE & SHINE) Act (S. 4353); the Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act (S. 1133); and the Auditory Early Detection and Intervention Act (S. 4052).

Senate Finance Committee Releases Draft on Mental Health. On June 15, leaders of the Senate Finance Committee released a discussion draft focused on youth mental health. This discussion draft is the second of five areas under development to be released as the committee seeks to push forward a comprehensive set of mental health reforms this year. The first discussion draft – focusing on telehealth policy – ​​was released on May 26, and additional material on workforce, parity and integrated care is expected in the coming weeks.

This part discusses policies aimed at improving the mental health of young people, mainly within the framework of the Medicaid program. The draft provisions include:

  • Eliminate barriers to coordinated care by allowing all providers to receive Medicaid reimbursement for behavioral and physical health services provided on the same day;

  • Support mental health in schools by updating state Medicaid guidelines to clarify authorized payments and identify strategies to reduce administrative burden;

  • Improve enforcement and monitoring of Medicaid’s early and periodic screening, diagnosis, and treatment (EPSDT) benefits;

  • Streamlined enrollment of out-of-state providers in another state’s Medicaid program; and

  • Lead Medicaid to guide states on how to cover family care services treatment for Medicaid-enrolled youth in care with acute mental health needs.

A press release from the Finance Committee on the draft discussion can be found here.

Administration

HHS OCR publishes guidance on HIPAA and audio-only telehealth. The Office of Civil Rights (OCR) of the Department of Health and Human Services (HHS) recently issued guidance on how the rules of the Health Insurance Portability and Accountability Act of 1996 (HIPAA ) allow covered healthcare providers and health plans to use audio-only telehealth remote communication technologies.

During the COVID-19 Public Health Emergency (PHE), the OCR exercised its enforcement discretion and did not impose sanctions on covered healthcare providers for non-compliance with HIPAA rules requirements in related to the bona fide provision of telehealth using non-public contacts. remote audio or video communication technologies. Therefore, Covered Healthcare Providers may use any non-public remote communication technologies available for telehealth, even when those technologies, and the manner in which they are used, may not be fully HIPAA compliant.

This guide includes four FAQs that address what will happen when the PHE expires and the OCR application flexibilities end:

  • Does the HIPAA Privacy Rule allow covered healthcare providers and health plans to use remote communication technologies to provide audio-only telehealth services?

  • Do covered healthcare providers and health plans have to meet HIPAA security rule requirements in order to use remote communication technologies to provide audio-only telehealth services?

  • Do HIPAA rules allow a covered healthcare provider or health plan to conduct audio-only telehealth using remote communication technologies without a business associate agreement in place with the provider?

  • Do HIPAA rules allow covered healthcare providers to use remote communication technologies to provide audio-only telehealth if an individual’s health plan does not provide coverage or payment for these services?

Generally, the answer to each of these FAQs is “yes” or “yes, under certain circumstances”. For more detailed answers, please refer to the full instructions, which also include links to additional OCR resources.

Courts

Supreme Court rules in favor of hospitals in Case 340B. On June 15, the United States Supreme Court issued a unanimous opinion in American Hospital Association v. Becerra, the case brought by the American Hospital Association (AHA), Association of American Medical Colleges (AAMC), and America’s Essential Hospitals (AEH) against HHS arguing that Medicare payment reductions on 340B drugs in 2018 and 2019 were illegal.

The Court ruled 9-0 in favor of the Hospital Groups, although it did not use the case to challenge the Administration’s interpretative authority and did not provide a specific remedy. The case will now return to a lower court for further deliberations, including appeals.

In a joint statement released after the decision, the AHA, AAMC and AEH said, “Now that the Supreme Court has ruled, we look forward to working with the administration and the courts to develop a reimbursement plan. of the 340 B hospitals affected by these illegal cuts while ensuring that the rest of the hospital field is not disadvantaged as they also continue to serve their communities.

See our 340B Dispute Tracker for more details.

Courts

  • The Senate HELP Committee held a hearing entitled “An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning”.

  • HHS and the United States Department of Agriculture (USDA) have called for nominations for the 2025 Dietary Guidelines Advisory Committee. Nominations to serve on the committee – which will provide independent, science-based advice and recommendations to HHS and USDA and will apply a healthy equity lens in reviewing the evidence to ensure that factors such as socioeconomic status, race, ethnicity, and culture are described and considered to inform guidance resulting – are due by July 15.

  • The HHS Office of Inspector General (OIG) released a report titled “Inaccuracies in Medicare Race and Ethnicity Data Impede the Ability to Assess Health Disparities,” which included several recommendations at CMS focused on improving its data on race and ethnicity.

  • The Medicare Payment Advisory Commission (MedPAC) released its June 2022 report to Congress, providing insight and recommendations on Medicare payment policies, as well as issues related to access and quality of care.

  • HHS announced that 253,000 parents gained access to 12 months of postpartum coverage through Medicaid and Children’s Health Insurance Program (CHIP) extensions.

Health Policy Break Room Podcast

On Sunday, a bipartisan group of senators announced a framework for federal gun violence prevention legislation. As the details of this agreement continue to emerge this week, Debbie Curtis and Rodney Whitlock talk about the process of turning action into legislation and the critical role health care will play in this meaningful bill.

Diagnosis next week

The House and Senate will be in session next week, with the House due to introduce several health-related bills, including mental health legislation and a bill to create the Advanced Research Projects Agency for Health. health (ARPA-H). We are still awaiting the legislative text on the gun violence prevention agreement announced earlier this week. We also continue to await the imminent Supreme Court ruling on abortion rights.