THIS WEEK’S DOSE

• Congress Continues a Quiet Recess. Lawmakers will be back on September 9, 2024, so this edition focuses primarily on executive branch actions.
• CMS Finalizes New TCET Pathway. The Centers for Medicare & Medicaid Services (CMS) will provide expedited coverage for a small number of breakthrough devices via the Transitional Coverage for Emerging Technologies (TCET) pathway.
• CMS Announces Changes to ACO REACH Model. The improvements to model sustainability, benchmark accuracy and risk management will begin in 2025.
• ASTP Proposes to Require Government Grantees to Use Certified Technologies. The proposal comes during the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) push to improve information sharing.
• CMS Announces Negotiated Prices for 10 Medicare Part D Drugs. The negotiated prices range from 38% to 79% less than list prices and are set to go into effect in 2026.
• White House Launches “Time Is Money” Initiative. The initiative aims to address burdensome business practices and includes action on healthcare.

ADMINISTRATION

CMS Finalizes New TCET Pathway. The final procedural notice, effective immediately, creates a new pathway that uses existing national coverage determination and coverage with evidence development (CED) processes to expedite Medicare coverage of certain breakthrough devices. Under the finalized TCET pathway, eligible US Food & Drug Administration (FDA) designated breakthrough devices that fall within a Medicare benefit category can obtain national coverage for several years as the manufacturer develops evidence to address gaps identified through a contractor-generated evidence preview and pursuant to an evidence development plan. CMS, however, notes that it expects only a handful of devices to use this new pathway.

Along with the final procedural notice for TCET, CMS published a blog post and a fact sheet. CMS also issued finalized versions of the following guidance documents:

• Guidance on CED.
• CMS National Coverage Analysis Evidence Review guidance on fit-for-purpose study designs.
• Clinical Endpoints Guidance: Knee Osteoarthritis, the first in a series of clinical endpoints guidance documents that review health outcomes and their clinically meaningful differences within priority therapeutic areas.

CMS Announces Changes to ACO REACH Model. Starting in performance year (PY) 2025, CMS will make changes to improve the Accountable Care Organization Realizing Equity, Access, and Community Health (ACO REACH) Model in response to findings from the PY 2022 report. Changes are related to:

• Model sustainability: Includes changes to maintain the current benchmark blend of historical and regional expenditures for standard ACOs and updating the risk adjustment model.
• Benchmark accuracy: Includes increasing the ceiling for the regional blend adjustment to benchmark for high needs population ACOs and applying the Standardized Area Deprivation Index for the health equity benchmark adjustment.
• Risk management: Includes improving statistical reliability of the benchmark for voluntarily aligned beneficiaries and adjusting PY 2023 expenditures for significant, anomalous and highly suspect billing.

The full details of the model’s updates can be found here.

ASTP Proposes to Require Government Grantees to Use Certified Technologies. In an effort to promote interoperability, ASTP’s proposed rule would update the US Department of Health & Human Services’ (HHS’s) acquisition regulation to require government grantees to buy health information technology that is certified by ASTP. If finalized, this policy would mean that optional certification criteria in the recent HTI-2 proposed rule would become mandatory for government grantees.

The proposed rule is open for public comment until October 8, 2024. For more information, read the ASTP blog post and the McDermott+ +Insight on the HTI-2 proposed certification criteria.

CMS Announces Negotiated Prices for 10 Medicare Part D Drugs. The negotiated prices are set to take effect in 2026 and save between 38% and 79% of the drugs’ list prices. CMS projects that the negotiated prices will save $1.5 billion. The prices are in the table below.

CMS will select up to 15 additional drugs covered under Part D for negotiation for 2027 by February 1, 2025. Legal challenges to drug price negotiation are ongoing and could impact the program going forward.

The press release can be found here, and the fact sheet can be found here.

White House Launches “Time Is Money” Initiative. The Administration highlights this government-wide initiative as cracking down on time-consuming and burdensome business processes. Healthcare components of the initiative include a requirement for federal employee health plans to provide an online opportunity to submit claims, and a letter to health insurance CEOs from HHS Secretary Becerra and US Department of Labor Acting Secretary Su that includes a call to implement actions such as:

• Offering online claim submissions.
• Denying claims only where appropriate and providing clear steps to appeal the decision.
• Prioritizing clear language and avoiding jargon.
• Improving customer service.

The letter also anticipates a meeting of healthcare CEOs with the Secretary. The fact sheet on the broader initiative can be found here.

QUICK HITS

• CMS Issues New Medicaid Guidance on Family Planning Services. The guidance specifies that states have flexibility regarding what family planning services they cover, but they must ensure that enrollees can access services from a provider of their choice. CMS also provides states with best practices for complying with this obligation and existing confidentiality requirements.
• House and Senate Republican Committee Leaders Request Review of Medicare Part D Premium Stabilization Demonstration. House Ways & Means Committee Chair Smith (R-MO), House Energy & Commerce Committee Chair Rodgers (R-WA) and Senate Finance Committee Ranking Member Crapo (R-ID) sent a letter to the US Government Accountability Office requesting the review and accusing the Administration of deflating seniors’ premiums without budgetary analysis, clear statutory basis or credible research goals. Their press release can be found here.
• CMS Innovation Center Seeks Submissions for 2024 Rural Health Hackathon. The event is a series of in-person sessions designed to generate and construct ideas to address rural challenges, such as access to care, care delivery model and workforce. The press release can be found here.
• CMS Updates Guidance for Consumers Dually Enrolled in Medicaid and Marketplace Coverage. For 2024, CMS will alert consumers of their dual enrollment in Medicaid and the Marketplace and ask them to take action themselves. This is a change from CMS’s previous policy of terminating Marketplace subsidies for dually enrolled individuals. This guidance aims to mitigate consumer harm due to potentially inaccurate data caused by the Medicaid unwinding.
• Administration Awards Cancer Moonshot Funds. The Health Resources & Services Administration (HRSA) awarded almost $9 million to 18 HRSA-funded health centers to improve access to cancer screenings in underserved communities, and President Biden traveled to Atlanta to announce that the Advanced Research Projects Agency for Health awarded $150 million in funding for development of tumor-removal surgeries.
• FDA Announces Roster of Digital Health Advisory Committee. The committee will hold a two-day meeting on November 20 – 21, 2024. The roster can be found here.

NEXT WEEK’S DIAGNOSIS

Congress is in recess until September 9, 2024. The Check-Up will be on hiatus until September 6, 2024.