Health Policy Report (8/29)

Both chambers are recessed to allow for district work and will return to Capitol Hill in September. The Senate returns first on Tuesday, September 6, followed by the House on Tuesday, September 13.

Biden Administration Issues Final Surprise Billing Rules

Last week, the Departments of Labor (DOL), Health and Human Services (HHS), and Treasury issued final rules(rule; press release; fact sheet) entitled, “Requirements Related to Surprise Billing.” These final rules concern standards related to the arbitration process in implementing the No Surprises Act (NSA) and seek to clarify federal processes to protect against surprise medical billing. Notably, the rules make certain medical claims payment processes more transparent for providers by finalizing and adding additional disclosure requirements to information that providers and insurers must share about the qualifying payment amount (QPA). The rules also clarify the process for providers and health insurance companies to resolve disputes with one another.

Surprise medical bills happen when an individual receives medical care from providers that are outside of their health plan’s network, either in an emergency or non-emergency scenario. Typically, the health plan does not cover the entire out-of-network cost. To recoup costs, the out-of-network provider then bills the individual who received the medical care for the difference between the billed charge and the amount paid by their insurance plan. Congress took action to largely ban this practice by passing the NSA within the Consolidated Appropriations Act, 2021 (CAA, 2021).

CMS Outlines Medicaid and CHIP Continuous Enrollment Unwinding for Stakeholders and Partners

Last week, the Centers for Medicare and Medicaid (CMS) held a webinar entitled “Medicaid and CHIP Continuous Enrollment Unwinding: What to Know and How to Prepare, A Partner Education Monthly Series.” Staff from CMS provided an overview of the Health Insurance Marketplace, a timeline for the consumer experience, an overview of key Federally Facilitated Marketplace (FFM) processes, and updates on plans for COVID-19 public health emergency (PHE) unwinding. Additionally, the staff explained several resources for partners and stakeholders, including engagement and outreach toolkits and training materials for State-based Marketplaces (SBMs) and Marketplace health plans. The staff pointed stakeholders to visit the National Stakeholder Calls Webpage to watch previous stakeholder webinars and view additional resources on the Medicaid unwinding process. Notably, CMS intends to release guidance soon on the impact of the Inflation Reduction Act (IRA) for connecting eligible beneficiaries to Medicaid and CHIP coverage.

FDA Discusses ALS Therapy Development, Neurodegenerative Disease Drug Approvals

On Wednesday, the Food and Drug Administration (FDA) held a stakeholder webinar on the Accelerating Access to Critical Therapies (ACT) for ALSAct, where both FDA and National Institutes of Health (NIH) officials discussed agency plans “to move the needle” on the development of amyotrophic lateral sclerosis (ALS) therapies. Specifically, leaders and subject matter experts from the agencies walked through the FDA’s Rare Neurodegenerative Disease Grant Program, the FDA Action Plan for Rare Neurodegenerative Diseases and the NIH/ National Institute of Neurological Disorders and Stroke (NINDS) Grant Program for Research Utilizing Data from Expanded Access. Within these discussions, officials pointed toward the need for the development of digital health technologies, use of real-world evidence, utilization of public-private partnerships, and increased clinical trial diversity, among other items.

CMS Indefinitely Delays Radiation Oncology Model

The Centers for Medicare and Medicaid Services (CMS) officially delayed implementation of the Radiation Oncology (RO) Model. The Model was originally set to begin on January 1, 2021, and has been pushed back multiple times until January 1, 2023. CMS’s Innovation Center (CMMI) intended for the Model to explore cost saving opportunities by requiring prospective, site-neutral, episode-based payments for radiation therapy. Initial implementation of the Model would have required randomly selected providers across the U.S. to participate in the Model. However, radiation oncologists were critical of the RO Model, requesting that CMS allow it to be voluntary and streamlining the payment methodology. Additionally, they supported episodic payments but highlighted concerns of reduced payment rates to physicians. While the RO Model is on hold — and CMS promised six-months’ notice before determining a new start date for the Model — the agency appears committed to reworking and instating the RO Model in the future.