Health Care Checkup
December 21, 2023
THE BIG PICTURE: KEY CONGRESSIONAL & EXECUTIVE BRANCH DEVELOPMENTS
The Senate wrapped up its session on Wednesday afternoon without holding a vote for a security supplemental spending package. Per a joint statement released by Leaders Schumer and McConnell, negotiations will continue on a security supplemental spending package with the hope of finalizing an agreement in January. The House adjourned last week, and both houses of Congress are expected to return to work in January. 

A rule setting fees for filing No Surprises Act billing arbitration cases was finalized by the Biden administration following a slew of litigation over dispute resolution portals created under the law. The rule, released Monday, would raise fees from $50 to $115 per filing, lower than the $350 fee the government had earlier set for filings.

On Tuesday, the Department of Labor said it wants to unwind a 2018 rule that broadened the criteria of employers and groups that could offer association health plans.
What to Expect Next Week:

The House and Senate are in recess and will reconvene on Monday, January 8 (Senate) and Tuesday, January 9 (House).

When Congress returns, it will face the prospect of a partial government shutdown within just 10 days and another important spending deadline in early February, along with continued work on the supplemental and many other legislative priorities.

The Checkup will also return the second week of January. Until then, Merry Christmas and Happy Holidays! 
DEEP DIVE
Congressional:

Senate Leaves for Recess Without Passing Security Supplemental Spending Package
The Senate wrapped up its session on Wednesday afternoon without holding a vote for a security supplemental spending package. On Tuesday night, the Senate passed a three-month extension of the FAA reauthorization until March 8 via unanimous consent. Per a joint statement released by Leaders Schumer and McConnell, negotiations will continue on a security supplemental spending package with the hope of finalizing an agreement in January. The House adjourned last week, and both chambers are expected to return the week of January 8, with a focus on passing all 12 appropriations bills before the January 19th and February 2nd deadlines.
 
115 Organizations Call on Congress to Reauthorize PAHPA
On Monday, Senate Health, Education, Labor and Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) released a statement highlighting the 115 organizations, including hospital, public health, and pharmaceutical groups, who have called on Congress to reauthorize the bipartisan Pandemic and All-Hazards Preparedness Act (PAHPA), which expired on September 30. In July, the HELP Committee passed legislation to reauthorize PAHPA by a bipartisan vote of 17-3, but it has yet to be fully reauthorized by Congress. Cassidy stated, “Providing a strong PAHPA framework is crucial to improving our readiness towards the next pandemic, natural disaster, attack, or accident that puts Americans’ health and safety at risk.” Read the press release here.

Notable Bills Introduced:

Senators Whitehouse, Barrasso, Welch, Tillis, and Colleagues Introduce Bipartisan Legislation to Incentivize Better Health Care at Lower Costs 
Late last week, Senators Sheldon Whitehouse (D-RI), John Barrasso (R-WY), Peter Welch (D-VT), Thom Tillis (R-NC), Bill Cassidy, M.D. (R-LA), John Thune (R-SD) and Marsha Blackburn (R-TN) introduced the Value in Health Care Act. The bipartisan legislation would update the program parameters of Medicare’s Alternative Payment Models (APMs) to incentivize participation in Accountable Care Organizations (ACOs). The changes would increase participation in these value-based health programs, which are designed to improve the quality of care and health outcomes for seniors while lowering costs. Read the press release here and the section-by-section here.
 
Reps. Fitzpatrick, Dingell Introduce the Knockout Cancer Act
Late last week, Representatives Brian Fitzpatrick (R-PA) and Congresswoman Debbie Dingell (D-MI) introduced the Knockout (K.O.) Cancer Act of 2023. The bipartisan legislation boosts funding for the National Cancer Institute by 25 percent over fiscal years 2024 through 2028 to more appropriately align with the current cancer mortality rates. Additionally, the Knockout Cancer Act asks Congress for a report on the devastating shortage of cancer drugs. Read the press release here and the bill here.

Rep. Craig Leads Bipartisan Effort to Address Critical Medication Shortages and Reduce American Reliance on China
Late last week, Representatives Angie Craig (D-MN), Jefferson Van Drew (R- NJ), and Abigail Spanberger (D-VA) introduced bipartisan legislation to strengthen domestic medication supply chains and reduce American reliance on China for critical medications. The bipartisan RAPID Reserve Act would encourage the domestic production of critical medications and incentivize American-based manufacturers to increase their reserves of these medications to prepare for future public health threats and supply chain challenges. Read the press release here and the bill here.

McGovern, Malliotakis, Pingree, Evans, and Fitzpatrick Introduce Legislation to Create a Medically Tailored Meals Demonstration Program in Medicare
Late last week, Representatives James McGovern (D-MA), Nicole Malliotakis (R-NY), Chellie Pingree (D-ME), Dwight Evans (D-PA), and Brian Fitzpatrick (R-PA) introduced bipartisan legislation to establish a nationwide pilot program through Medicare to provide seniors with diet-impacted diseases medically tailored meals in their homes. The Medically Tailored Home-Delivered Meals Demonstration Pilot Act would test various Medicare payment and delivery models to improve health outcomes, reduce the rate of hospital readmissions, and increase access to healthy foods while saving the Medicare program money. Read the press release here and the bill here

Executive Branch:

HHS Presses States to Preserve Kids’ Coverage
On Monday, HHS Secretary Xavier Becerra pressed governors to remove discretionary barriers that impede access to children’s health coverage in a letter sent to governors of nine states: Arkansas, Florida, Georgia, Idaho, Montana, New Hampshire, Ohio, South Dakota, and Texas. The administration also announced that it will be extending all of its beneficiary-focused flexibilities, like automatic renewals, until the end of 2024. The moves come after Medicaid and Children’s Health Insurance Program enrollment for children declined significantly since states resumed regular eligibility checks, according to a Centers for Medicare & Medicaid Services analysis of state enrollment figures. Nationwide, Medicaid and CHIP enrollment for children decreased by 2.2 million, or 5.3%, between March and September 2023. Becerra urged governors to take steps such as removing barriers like CHIP enrollment fees and premiums, reducing call center wait times, collaborating with community partners to increase outreach efforts, adopting waivers to simplify and automate renewals, and expanding Medicaid so that children aren’t at risk of losing coverage once they reach age 19. Read the HHS press release here.
 
DoL Proposes Rolling Back Association Health Plan Rule
On Tuesday, the Department of Labor (DoL) said it wants to unwind a 2018 rule that broadened the criteria of employers and groups that could offer association health plans. The definition allowed unrelated groups of employers, including self-employed individuals, to qualify as a single employer that could offer a health plan to their workers. That allows those employers to evade consumer protections established by the 2010 health care law, the department said in a press release announcing the proposed rule Tuesday. But the 2018 rule was never fully implemented. A U.S. District Court decision set aside the criteria in 2019, and the department said it is not aware of any existing association health plans that formed based on the rule. The DoL said it is seeking public comments on whether it should issue more rule-making on association health plans. Read the proposed rule here.
 
No Surprises Act Arbitration Fee Rule Responds to Court Decision
A rule setting fees for filing No Surprises Act billing arbitration cases was finalized by the Biden administration following a slew of litigation over dispute resolution portals created under the law. The rule, released Monday, would raise fees from $50 to $115 per filing, lower than the $350 fee the government had earlier set for filings. The regulation responds to an August ruling from the US District Court for the Eastern District of Texas that the Department of Health and Human Services, the Department of Labor, and the Internal Revenue Service violated the Administrative Procedure Act by raising arbitration filing fees without proper notice and comment. The ruling favored challengers Texas Medical Association and additional medical providers who complained that the agencies hadn’t established “a fair and workable” process for payment disputes “that allows out-of-network physicians to obtain reasonable compensation for their services.” Read the CMS fact sheet here and the rule here.

FTC, DOJ Finalize Merger Guidance
On Monday, the Federal Trade Commission (FTC) and the Justice Department finalized new merger guidelines that will apply across the economy, including the healthcare sector. The rules largely align with the agencies’ proposal this summer aimed to prevent excessive concentration and bar mergers that eliminate competition or entrench a dominant position. Courts have the final say after the FTC and the DOJ take on mergers. In the pharmaceutical sector, the FTC has focused on bundled discounts for products, which it argues could cement market dominance. Pharmaceutical companies have argued that given the substantial cost of drug development, mergers, and acquisitions are key to getting new treatments across the finish line and that the proposed guidelines created a “chilling effect” for mergers and acquisitions. Read the merger guidelines here and the press release here.
CONGRESSIONAL HEARINGS & EVENTS
House & Senate Hearings and Markups:

None. The House and Senate are in recess for the next two weeks. 
ADMINISTRATION ANNOUNCEMENTS
Centers for Medicare & Medicaid Services
Food and Drug Administration
Guidance Documents from the Centers for Disease Control and Prevention
National Institutes of Health
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Washington, DC 20005
202-585-0258