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This week (Jan. 09-13)

The House is scheduled to be in session next week and the Senate is in recess until January 23.

Last week (Jan. 02-06)

Health Care Highlights

118th Congress off to a rocky start. On Tuesday (Jan. 3), the 118th Congress convened. Senate Democrats conducted convening and swearing-in activities and will be on recess until Jan. 23. In the House, Rep. Kevin McCarthy (R-CA) has failed to gain a majority of votes (which is generally 218) that is required for the House Speakership. While there were some indications late yesterday of a potential deal between McCarthy allies and the conservatives who have thus far withheld their support, it remains to be seen whether the development breaks the logjam and if the voting process will continue into the weekend or next week. Without a Speaker, the House cannot officially begin legislative business and chairmanships of committees, including key health care committees, cannot be decided.

FDA approves new Alzheimer's drug. On Friday (Jan. 6), the Food and Drug Administration granted accelerated approval to Eisai's Leqembi, a new Alzheimer's disease treatment for people with mild cognitive impairment or early stage Alzheimer's. FDA's approval is based on preliminary evidence that the drug reduces the amount of beta-amyloid, a protein in the brain believed to contribute to Alzheimer's.

CMS issues guidance to increase access to Medicaid-covered specialty care. On Thursday (Jan. 5), the Centers for Medicare & Medicaid Services (CMS) issued updated guidance to state health officials clarifying how Medicaid and the Children's Health Insurance Plan (CHIP) covers and pays for interprofessional consultations. CMS said the guidance aims to increase access to behavioral health care and other specialty care.

FTC proposes to ban noncompete clauses from employer contracts. On Thursday (Jan. 5), the Federal Trade Commission (FTC) issued a proposed rule that would ban noncompete clauses in contracts often used by health care employers. The proposal is part of the FTC's strategy to reduce anticompetitive activity in the health care industry and fulfills a component of President Biden's July 2021 executive order on promoting competition in the United States.

HHS Office for Civil Rights proposes updates to conscience rules. On Thursday (Jan. 5), the Department of Health and Human Services' (HHS) Office for Civil Rights released a draft rule that would partially rescind a 2019 rule on protecting health care professionals' conscience rights and maintain a 2011 complaints process to address providers who wish to decline services. The 2019 rule was challenged in court and ultimately never went into effect.

CMS clarifies Medicaid coverage for nonmedical services (SDOH). On Wednesday (Jan. 4), CMS released guidance clarifying how states can use a Medicaid managed care option to provide nonmedical services to reduce health disparities and meet enrollees' social needs. The option, finalized under the 2016 Medicaid and CHIP managed care final rule, allows states and managed care plans to request CMS' approval to cover alternative services or settings in lieu of a service or setting covered under the state plan.

CMS releases updated enrollment figures. On Wednesday (Jan. 4), CMS released the latest enrollment figures for Medicare, Medicaid, and the CHIP. The data show as of September 2022 the number of Medicare enrollees had risen to about 65 million people, including 30,119,512 who are enrolled in Medicare Advantage or other health plans, and nearly 91 million enrolled in Medicaid and CHIP.

CMS releases performance results for End Stage Renal Disease ETC Model. On Wednesday (Jan. 4), CMS published performance information and results for Measurement Year 1 (MY1) of the End Stage Renal Disease (ESRD) Treatment Choices (ETC) Model available. The data show the majority of ETC participants received either 0% or +2% adjustment to claims.

FDA expands access to mifepristone. On Tuesday (Jan. 3), the Food and Drug Administration officially updated the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program to allow retail and online pharmacies to become certified to distribute the drug, which is used in conjunction with misoprostol for first trimester abortions. In related news, on Monday (Dec. 23), the Department of Justice issued a legal opinion allowing the U.S. Postal Service to deliver Mifepristone and misoprostol via mail in states with limitations on their use.

ICYMI: Health Policy Updates from Dec. 26-30

Affordable Care Act exchange plan sign ups on the rise. On Tuesday (Dec. 27), the Centers for Medicare and Medicaid (CMS) announced that nearly 11.5 million people had selected a qualified health plan as of Dec. 15 — the deadline for coverage effective Jan. 1 in most states. CMS reported that the figure, which does not specify those who have enrolled in a plan by paying their first month's premium, is up about 1.8 million or 18% from the previous open enrollment period.

Reports, Studies, and Journals

Centers for Medicare and Medicaid Services. Initial Report on the Independent Dispute Resolution (IDR) Process. The CMS report shows there were more than 90,000 submissions to the IDR portal from April 15 through Sept. 30, 2022, far outpacing federal estimates. The disputes primarily focused on emergency or non-emergency items or services (as opposed to air ambulance services) submitted by out-of-network health care providers and facilities.

HHS Office of Inspector General. Manufacturers May Need Additional Guidance To Ensure Consistent Average Sales Price Calculations. The report, which examined the accuracy of average sales prices for Medicare Part B drugs, found a few inconsistencies in manufacturers' ASP calculations and identified areas where CMS could provide additional guidance.

HHS Office of Inspector General. CMS Should Bolster Its Oversight of Manufacturer-Submitted Average Sales Price Data To Ensure Accurate Part B Drug Payments. The report, which was required under the Consolidated Appropriations Act, found CMS was unable to determine Medicare Part B payment amounts for 8% of drugs at least once between 2016 and 2020 due to invalid or missing data on products' average sales price.

Substance Abuse and Mental Health Services Administration. 2021 National Survey on Drug Use and Health (NSDUH) Report. The annual report found 94% of people with a substance disorder in 2021 went without treatment and that those with a serious mental health illness were more likely to receive treatment than those with any mental illness.

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