THIS WEEK’S DOSE

• Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new speaker. It is unknown if that vote will occur quickly. If not, it will raise questions of what can be done in the House while it is governed by a non-elected speaker pro tempore as the clock ticks toward the November 17 deadline for government funding.
• New Senator: California Governor Gavin Newsom quickly appointed Laphonza Butler to fulfill the term of Senator Dianne Feinstein, who passed away last week. Senator Butler (D-CA) was sworn in as the nation’s third Black woman senator.
• Laboratory Developed Tests Proposed Rule: The US Food and Drug Administration (FDA) published a proposed rule that would impose regulatory requirements for laboratory developed tests (LDTs).
• DEA Telehealth Flexibility Extended: The US Drug Enforcement Administration (DEA) issued a temporary rule that further extends the ability to prescribe controlled substances via telemedicine without an in-person visit.
• Over-the-Counter Preventive Services RFI: Three federal agencies released a request for information (RFI) on access to a range of over-the-counter (OTC) preventive services.

CONGRESS

Turmoil Among House Republicans Leaves Legislative Agenda Unclear. On October 3, after a small group of detractors successfully forced a vote, the House voted to remove Kevin McCarthy as speaker. The House is currently in uncharted territory, with Rep. McHenry (R-NC) serving as an interim speaker pro tempore for an undetermined amount of time, until a new speaker can be elected. The House quickly recessed with a plan to return to hold an election for a new speaker on October 11.

Whether and to what extent House committees will continue legislative business while working to select a new speaker is not yet clear. As a result, the advancement of key healthcare priorities, including the extensions of expiring healthcare programs, is uncertain. What isn’t uncertain is the date of November 17—the day the current continuing resolution funding government expires.

ADMINISTRATION

DEA Further Extends Telehealth Flexibilities. DEA issued a temporary rule that further extends the ability to prescribe controlled substances via telemedicine without in an in-person visit through December 31, 2024. The current flexibility was set to expire November 11, 2023. The temporary rule comes on the heels of a two-day listening session on September 12 and 13, where the agency heard from healthcare practitioners, experts, advocates, patients, and other members of the public to help inform DEA’s regulations on prescribing controlled substances via telemedicine.

Specifically, the temporary rule will extend the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency through December 31, 2024. This includes any practitioner-patient telemedicine relationships that have been or will be established up to December 31, 2024. (This was previously only allowed for relationships established on or before November 11, 2023.) The temporary rule will take effect on November 11, 2023. The DEA anticipates releasing a final rule in the fall of 2024.

FDA Publishes LDT Proposed Rule. The FDA published a long-awaited proposed rule on LDTs that, if finalized as proposed, would regulate virtually all LDTs as medical devices. The proposal also raises several critical (and unanswered) questions, including whether the FDA has legal authority to regulate LDTs, whether the agency will allow some type of grandfathering for existing tests and whether an exclusion for academic medical centers will be offered.

The proposed rule is open for comment until December 2. For more information, read our McDermott On the Subject here and our Regs & Eggs blog post here.

Agencies Request Public Input on Coverage of OTC Preventive Services. The US Departments of Health and Human Services (HHS), Labor and the Treasury released an RFI on OTC preventive items and services. The RFI solicits comment on access to a range of OTC items recommended by experts for preventive care, including contraceptives, tobacco smoking cessation products, COVID-19 tests, folic acid during pregnancy and breastfeeding supplies.

The RFI includes questions related to health equity, including whether certain populations face disproportionate challenges in accessing OTC preventive products. The RFI also seeks feedback on the potential benefits and challenges if OTC preventive products were provided without cost-sharing and without a prescription by a healthcare provider.

Comments must be received no later than 5 pm EST on December 4. Read the Centers for Medicare & Medicaid Services press release here.

Administration Releases Additional Guidance on No Surprises Act QPA and IDR Portal. On October 6, HHS, the Department of Labor and the Department of Treasury, along with the Office of Personal Management (OPM) provided additional guidance on the No Surprises Act qualifying payment amount (QPA) and independent dispute resolution (IDR) portal.  With respect to the QPA, the Departments note they will exercise enforcement discretion from now until May 1, 2024 to insurers, stating that “the Departments and OPM generally do not intend to issue interim guidance… addressing the QPA methodology in response to Texas Medical Association (TMA) III. Accordingly, plans and issuers are expected to calculate QPAs using a good faith, reasonable interpretation of the applicable statutes and regulations that remain in effect after the TMA III decision.” Similarly, the Departments will exercise enforcement discretion for providers who bill the patient the incorrect cost-sharing amount based on a previously-calculated QPA.  The guidance encourages States that are the primary enforcers of the relevant No Surprises Act provisions to adopt a similar approach to enforcement. The Departments also clarify that insurers are still required to provide all the disclosures related to the QPA when they submit the initial payment or notice of denial. However, the Departments will exercise enforcement discretion for disclosures related to a QPA that was incorrectly calculated. For more information, read here. With the TMA III Court rule, the Departments explicitly clarify that they disagree with the decision in TMA III and the Department of Justice will appeal the decision.

The Departments have also reopened the Federal IDR portal for new single and bundled disputes. Processing of batched disputes, however, remains suspended while the Departments update batching guidance to align with the district court’s opinions and orders in TMA III and TMA IV. The Departments will allow parties impacted by the suspension of the Federal IDR process more time to submit and respond to new disputes, as follows:

• When IDR initiation deadline falls on a date beginning on August 3, 2023 – November 3, 2023, parties will have until November 3, 2023, to initiate a new dispute (essentially 20 business day after the Federal IDR portal reopens).
• For new disputes initiated between October 6, 2023 – November 3, 2023, the deadline for certified IDR entity selection will be 10 business days after initiation, and the deadline to submit fees and offers will remain 10 business days after certified IDR entity selection.
• Disputing parties that were engaged in certified IDR entity selection when the Federal IDR portal temporarily closed will have 10 business days from October 6, 2023, to agree on a certified IDR entity.

No specific timing related to batched disputes is provided and all other deadlines under the Federal IDR process remain unchanged. More information is available here.

Administration Moves Forward with Medicare Drug Price Negotiations. HHS announced that all 10 drug companies whose drugs were selected for price negotiation with Medicare for the first cycle of the program have decided to initially participate in those negotiations. The agency will also seek input from patients on the benefits and costs of these drugs, which accounted for $50.5 billion in total Part D gross costs between June 1, 2022, and May 31, 2023 (the time period used to determine which drugs were eligible for negotiation). Medicare enrollees taking the 10 selected drugs paid a total of $3.4 billion in out-of-pocket costs in 2022. The 10 companies participating in the Medicare Drug Price Negotiation Program can be found here.

COURTS

Federal Judge Denies Request to Block Medicare Negotiation. In related Medicare price negotiation news, US District Judge Michael J. Newman ruled against a request for a preliminary injunction by the US Chamber of Commerce in its lawsuit to stop the Medicare drug price negotiation program. His ruling came ahead of the October 1 deadline by which drugmakers whose products were named for negotiation were required to sign agreements to engage in the process or face the penalties. Newman also denied a request from the federal government to dismiss the case entirely. Several other lawsuits on the program are still pending.

QUICK HITS

• MedPAC Hosts October 2023 Meeting. The Medicare Payment Advisory Commission (MedPAC) met October 5 to discuss Medicare payment policy, nursing staffing ratios and prices of generic drugs under Part D. View the full MedPAC agenda and presentation slides here.
• CBO Releases Report on CMMI. The Congressional Budget Office (CBO) released a report indicating that while the Center for Medicare & Medicaid Innovation (CMMI) was initially envisioned as a way to save money, it instead increased spending by $5.4 billion in its first decade and is estimated to continue to increase spending in its second decade.
• CBO Releases Blog Post on Anti-obesity Medications. The blog post discusses recent trends in the availability and use of anti-obesity medications (AOMs). The blog also notes Medicare coverage of AOMs would result in increased use by enrollees and, at current AOM prices, would increase overall federal spending.
• SAMHSA Announces Almost $35 Million for Comprehensive Behavioral Healthcare, HIV Prevention and Care for Underserved Populations. The Substance Abuse and Mental Health Services Administration (SAMHSA) awards include funding for substance use disorder treatment for racial and ethnic minority populations at high risk for HIV/AIDS, a substance use and HIV prevention program for racial and ethnic minorities, and an integrated behavioral health and HIV care for unsheltered populations pilot project.
• ARPA-H Announces $330+ Million to Advance Cancer Moonshot Initiative, Improve Healthcare Research, Treatment and Outcomes. The Advanced Research Projects Agency for Health (ARPA-H) announced a series of research projects totaling more than $330 million dollars that will support biomedical health breakthroughs aimed at improving health solutions and healthcare for the US public. New ARPA-H initiatives include the Digital Health Security project, a 3D tissue printing project, a regenerative tissue project, the Defeating Antibiotic Resistance through Transformative Solutions project and research projects in support of the Cancer Moonshot objectives.

NEXT WEEK’S DIAGNOSIS

The Senate is scheduled to be in recess, while in the House the focus will be on electing a new speaker. It remains to be seen whether legislative activity will occur in House committees next week.

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