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.
