Congress will return for votes this week, with the Senate in first later today followed by the House tomorrow. As the December 16 government funding deadline draws nearer, appropriators are pushing to reach an agreement on topline funding levels for fiscal year (FY) 2023 — a key precursor to a year-end spending package. With divided government on the horizon, lawmakers appear motivated to tie up loose ends on several bipartisan legislative efforts prior to the start of the 118th Congress. However, cooperation between Democratic and Republican leadership will be crucial, especially in the evenly divided Senate. Any extraneous policy riders that imperil the omnibus’s chances of reaching 60 votes will likely fall by the wayside to ensure that the government remains funded past the December 16 deadline.
Capitol Hill Update
President Joe Biden signed a two-month continuing resolution (CR) (text; summary) late last week after congressional leadership struck a deal to keep the government funded until December 16. Barring a sudden and unforeseen change in the schedule, final passage of the CR will be the final vote either chamber takes until after the November midterm elections. Senators were originally slated to come in for a nine-day legislative work period to tackle the fiscal year (FY) 2023 National Defense Authorization Act (NDAA), but instead will remain in their respective states during the final weeks of the 2022 campaign. Regardless of who comes out on top on November 8, lawmakers will be faced with a hectic “lame duck” work period to close out the 117th Congress, with a particular focus on trying to strike an omnibus spending package for FY 2023 that could potentially carry a host of health policy priorities before the start of the new Congress.
House and Senate lawmakers will resume legislative business today as negotiations on a continuing resolution (CR) continue. In particular, discussions at the leadership level are likely to focus on reaching agreements on items that could potentially be added onto the stopgap, including energy permitting reforms and reauthorization of several user fee agreements at the Food and Drug Administration (FDA). Both of these proposals will require bipartisan cooperation to ensure that the CR can pass the Senate with a filibuster-proof majority — a factor that could prolong the talks into the final days leading up to the September 30 deadline. Meanwhile, members of the House Freedom Caucus have coalesced behind a strategy spearheaded by three GOP senators — including Sens. Mike Lee (R-UT), Rick Scott (R-FL), and Ted Cruz (R-TX) — in opposing a CR through mid-December. Instead, the Republican lawmakers have been pushing for a “clean” funding bill that maintains current federal spending levels until the new Congress begins in 2023
House lawmakers will return tomorrow to kick off the September work period. According to a “Dear Colleague” letter from Majority Leader Steny Hoyer (D-MD), leadership could file a continuing resolution (CR) to fund the government into mid-December for a vote prior to the end of the week. However, disagreements over policy riders — including the White House’s $47.1 billion supplemental funding request and energy permitting reforms — could shift the timing on this vote. In addition to the stopgap funding bill, lawmakers are slated to consider three bills out of the Oversight and Reform Committee that pertain to: (1) improving federal whistleblower protections (H.R. 2988); (2) modifying certain census bureau authorities to promote accuracy and fairness (H.R. 8326); and (3) prohibiting executive agency positions in the competitive service from being placed in the excepted service (H.R. 302). In the upper chamber, senators will be in session this afternoon to resume consideration of pending judicial nominations.
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.
Congress is set to break for the balance of the month and will return to action in September with a lengthy legislative to-do list. This includes, among other things: (1) government funding and the National Defense Authorization Act (NDAA) for FY 2023; (2) Food and Drug Administration (FDA) user fee agreements; and (3) the National Flood Insurance Program (NFIP), along with several other programs that are set to expire on September 30. Additionally, Democratic lawmakers will be scrambling to finalize other last-minute legislative wins — including permitting reform, tax extenders, retirement savings, water resources development projects, and more — before the conclusion of the 117th Congress.
Senate Democrats clinched final passage of their long-sought reconciliation bill over the weekend, sending the measure to the House for a final vote later this week. Democratic leadership reached a breakthrough late last week after Majority Leader Chuck Schumer (D-NY) offered a series of tweaks to tax and climate policies within the underlying bill to appease some concerns from Sen. Kyrsten Sinema (D-AZ), who was the last remaining holdout on the Inflation Reduction Act. Additionally, the Senate Parliamentarian’s “Byrd bath” rulings — along with the marathon “vote-a-rama” amendment process — resulted in a pair of key changes to the drug pricing policies within the filibuster-proof measure, including: (1) the removal of a provision that would have required drug companies to provide rebates if the cost of their products sold to private insurers exceed inflation; and (2) nixing a proposed price cap for insulin in the private marketplace.
The Senate will return to action on Monday as Democrats prepare to act on their newly-released Inflation Reduction Act. Text of the reconciliation bill, which includes an array of health, tax, clean energy, and climate policies, is currently being reviewed by the Senate Parliamentarian — a process that could result in additional changes to the legislation if its provisions run afoul of the chamber’s arcane budgetary rules.