ICYMI: Biden Administration Drops Appeal on the Copay Accumulator Decision

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The Biden Administration has dropped its previous appeal of an October U.S. District Court decision to strike down a 2021 rule allowing copay accumulators. House and Senate members urged the administration to drop its appeal, including via introduction of bipartisan, bicameral legislation, the HELP Copays Act. 19 States have banned copay accumulator programs.

 

Leadership Announces Bipartisan Agreement on Overall Funding Levels Ahead of First Shutdown Deadline

Leadership Announces Bipartisan Agreement on Overall Funding Levels Ahead of First Shutdown Deadline

Lawmakers return to session this week after congressional leadership on Sunday announced bipartisan agreement on topline spending amounts which provide a path to avoid a January 20 partial government shutdown. House Speaker Mike Johnson (R-La.) communicated the development in a Dear Colleague letter stating “The topline constitutes $1.590 trillion for FY24 – the statutory levels of the Fiscal Responsibility Act. That includes $886 billion for defense and $704 billion for nondefense.” Senate Majority Leader Chuck Schumer (D-N.Y.) and House Minority Leader Hakeem Jeffries (D-N.Y.) released a joint statement on the agreement stating that “The bipartisan topline appropriations agreement clears the way for Congress to act over the next few weeks in order to maintain important funding priorities for the American people and avoid a government shutdown.” Office of Management and Budget Director Shalanda Young characterized the work to pass funding for the Departments of Agriculture, Veterans Affairs, Energy, Agriculture-Food and Drug Administration, Transportation, and Housing and Urban Development ahead of the first government funding deadline on January 20 as “daunting,” with House Speaker Mike Johnson (R-La.) standing by his pledge to not pass another continuing resolution. No decisions have been reached regarding which health care related riders could be attached to the January spending vehicle. A Medicaid disproportionate share hospital cut delay and funding for several programs, including the community health center program, face a January 19 expiration. Other potential policy riders include a partial Medicare physician reimbursement fix, health transparency legislation, pharmacy benefit manager reforms, and site neutrality proposals. Congress has until February 2 to pass the Labor-Health and Human Services funding legislation and the other remaining annual appropriations bills.

 

Senators Comment on Co-pay Assistance Lawsuit

A bipartisan group of 19 senators led by Tim Kaine (D-Va.) and Roger Marshall (R-Kan.) are urging the Biden administration to drop its appeal of a court decision that struck down a regulation allowing insurers to avoid counting manufacturer co-pay assistance toward patients’ maximum out-of-pocket costs and deductibles. Patient advocacy groups, who brought the lawsuit against the U.S. Department of Health and Human Services (HHS), argued that the rule contradicts the statutory definition of cost sharing and would result in increased costs for patients. The lawmakers characterize the court decision as “an important step in the right direction for low-income and other eligible patients who rely on manufacturer and nonprofit copay assistance programs to alleviate affordability and access challenges for their medicines.” The letter also expresses support for the Help Ensure Lower Patient Copays Act (S. 1375/H.R. 830) that would prohibit the use of copay accumulators.

 

E&C GOP Launches Probe into Internal Scientific Disagreements at FDA

Republicans on the House Energy and Commerce Committee are investigating the handling of internal scientific disagreements related to regulatory decisions at the Food and Drug Administration (FDA). The lawmakers specifically cite the events surrounding the departure of several agency vaccine regulators following updated coronavirus vaccine recommendations in August 2021. Their letter seeks information on the adequacy of the FDA’s existing policies for handling scientific disagreements, and whether FDA leadership has taken retaliatory actions against dissenting FDA officials. It requests a written response from the agency by January 24.

 

FDA Approves FL Request to Import Drugs from Canada

The FDA has approved a plan from the state of Florida to allow the importation of prescription drugs from Canada. Before drug importation can commence, the state will first need to submit specific medications for FDA review and approval and ensure the products have been tested for authenticity and safety. In its letter authorizing the proposal, the agency stated that Florida has demonstrated that its plan “will significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety.” The agency has already denied a citizen petition from PhRMA to block the importation plan. Other states, including Colorado and New Hampshire, along with American Indian tribes have expressed interest in submitting similar applications to the FDA.

 

Congressional Retirements and Resignations

Reps. Doug Lamborn (R-Colo.) and Blaine Luetkemeyer (R-Mo.) each announced last week that they will not be seeking reelection this year. Lamborn has served in Congress since 2006 and is a member of the Armed Services and Natural Resources committees. Luetkemeyer was first elected to the House in 2008. He currently serves on the Financial Services and Small Business committees.

 

A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE
Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Feinstein (D), CA
Manchin (D), WV

 

HOUSE OF REPRESENTATIVES
Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Spartz (R), IN
Schiff (D), CA Bishop (R), NC
Slotkin (D), MI Lesko (R), AZ
Allred (D), TX Granger (R), TX
Trone (D), MD Buck (R), CO
Blunt Rochester (D), DE Burgess (R), TX
Napolitano (D), CA Santos (R), NY (effective Dec. 1, 2023)
Wexton (D), VA Wenstrup (R), OH
Kim, Andy (D), NJ McHenry (R), NC
Jackson, Jeff (D), NC McCarthy (R), CA (effective Dec. 31, 2023)
Sarbanes (D), MD Johnson, Bill (R), OH (effective Jan. 21, 2023)
Blumenauer (D), OR Ferguson (R), GA
Kilmer (D), WA Curtis (R), UT
Spanberger (D), VA Luetkemeyer (R), MO
Kildee (D), MI Lamborn (R), CO
Jackson Lee (D), TX
Phillips (D), MN
Cardenas (D), CA
Eshoo (D), CA
Manning (D), NC
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC

 

 

Upcoming Congressional Hearings and Markups

 

Senate Homeland Security and Governmental Affairs hearing “Harnessing AI to Improve Government Services and Customer Experience;” 10:00 a.m.; January 10

 

House Education and the Workforce Subcommittee on Health, Employment, Labor, and Pensions hearing “Lowering Costs and Increasing Access to Health Care with Employer-Driven Innovation;” 10:15 a.m.; January 11

 

House Veterans’ Affairs Committee oversight hearing “Rural Access: Is VA Meeting All Veterans Where They Live?;” immediately following committee business meeting; 10:15 a.m.; January 11

OMB Provides Clarification Around Debt Ceiling Agreement Sequestration Provision

OMB Provides Clarification Around Debt Ceiling Agreement Sequestration Provision

According to guidance released on December 22, the Office of Management and Budget (OMB) has instructed federal agencies to not prepare for sequestration cuts at this time. The federal government is currently operating under a continuing resolution (CR) that funds some parts of the government through January 19 and others through February 2. Congress faces an effective April 30 deadline to pass fiscal year 2024 appropriations, given that the most recent debt ceiling agreement included a provision to subject all discretionary spending to a 1% automatic cut should a stopgap spending measure still be in place past that date. The OMB guidance sought to provide clarification around the April 30 date, given that the law states that the 1% cut will be required if Congress relies on a CR beyond December 31; OMB, however, is not required to issue a sequestration order until the end of April. The guidance also confirms that cuts will be negated once lawmakers reach a full-year funding deal, even if that occurs after the April 30 deadline. The sequestration spending cuts would only apply during the period in which a CR is in place beyond April 30.

 

Ways and Means Chair Comments on NSA Implementation

House Ways and Means Committee Chairman Jason Smith (R-Mo.) has released a statement on the administration’s “bungled” implementation of the No Surprises Act, following the release of a Government Accountability Office (GAO) report outlining the challenges with implementation of the 2020 law. “GAO’s report is further evidence that the Biden administration is failing to deliver this law’s promised benefits to patients and providers,” Smith states. “While I’m pleased the bipartisan advocacy of members of the Ways and Means Committee has contributed to a reduction of the dispute resolution process administrative fee, there’s much more that needs to be fixed. We will continue our efforts to hold the Biden administration accountable for ignoring the law’s clear Congressional intent.”

 

Administration Extends IDR Flexibilities Following Portal Reopening

On December 21, the U.S. Departments of Health and Human Services, Labor, and the Treasury announced an extension of the deadline for parties to complete certain independent dispute resolution (IDR) activities that were impacted by the temporary suspension of IDR operations due to litigation surrounding the implementation of the No Surprises Act. Parties for whom the IDR initiation deadline under applicable regulations fell on any date between August 3, 2023, and December 14, 2023, will have until March 14, 2024, to initiate a new batched dispute or a new single dispute involving air ambulance services. For disputes initiated between August 3, 2023, and January 21, 2024, the administrative fee amount is $50 per party per dispute. For disputes initiated on or after January 22, 2024, the administrative fee amount is $115 per party per dispute. Certified IDR entity fees for disputes initiated on or after January 22, 2024, may be updated to fall within the ranges finalized in the December 21, 2023, final rules to establish the new administrative fee amount and certified IDR entity fee ranges. The administration previously reopened the federal IDR portal to process all dispute types on December 15.

 

IRA Medicare Reforms Effective Jan. 1

Several Medicare reforms passed as a part of the 2022 Inflation Reduction Act are now in effect, including an expansion of the federal Low-Income Subsidy (LIS) program. There will no longer be a partial LIS program providing a lower level of financial support for certain individuals. Effective January 1, 2024, anyone who qualifies for the LIS program will get full program benefits, covering the majority, if not all, out-of-pocket costs for prescription medications. The new year also brings the elimination of the 5% coinsurance for Medicare Part D beneficiaries who have entered the catastrophic phase of their coverage.

 

Former Texas Congresswoman Eddie Bernice Johnson Dies at 88

Former Congresswoman Eddie Bernice Johnson (D) passed away on Sunday at the age of 88. Johnson was a nurse before entering politics, first serving as a Texas state lawmaker before being elected to the House of Representatives in 1992. She was the first African American and woman to serve as chair of the House Committee on Science, Space and Technology. She retired in 2021 after serving nearly 30 years in Congress.

 

Congressional Retirements and Resignations

Rep. John Curtis (R-Utah) is planning to announce his candidacy for the U.S. Senate early this month. Curtis was first elected to Congress in 2017 and currently serves as a member of the House Energy and Commerce Committee. Sen. Mitt Romney (R-Utah) previously announced his decision to not seek a second Senate term in September.

 

A running list of members of Congress who are retiring or seeking other office can be found below.

 

SENATE

Stabenow (D), MI Braun (R), IN
Cardin (D), MD Romney (R), UT
Carper (D), DE
Feinstein (D), CA
Manchin (D), WV
 

HOUSE OF REPRESENTATIVES

Porter (D), CA Mooney (R), WV
Lee (D), CA Banks (R), IN
Gallego (D), AZ Spartz (R), IN
Schiff (D), CA Bishop (R), NC
Slotkin (D), MI Lesko (R), AZ
Allred (D), TX Granger (R), TX
Trone (D), MD Buck (R), CO
Blunt Rochester (D), DE Burgess (R), TX
Napolitano (D), CA Santos (R), NY (effective Dec. 1, 2023)
Wexton (D), VA Wenstrup (R), OH
Kim, Andy (D), NJ McHenry (R), NC
Jackson, Jeff (D), NC McCarthy (R), CA (effective Dec. 31, 2023)
Sarbanes (D), MD Johnson, Bill (R), OH (effective after March 2024)
Blumenauer (D), OR Ferguson (R), GA
Kilmer (D), WA
Spanberger (D), VA
Kildee (D), MI
Jackson Lee (D), TX
Phillips (D), MN
Cardenas (D), CA
Eshoo (D), CA
Manning (D), NC
Higgins (D), NY (effective Feb. 2, 2024)
Nickel (D), NC

 

Recently Introduced Health Legislation

H.R.6903 – To direct the Secretary of Defense to develop a plan to ensure an adequate supply of medications for the military health system. Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

 

H.R.6897 – To require the Secretary of Defense to establish a pilot program to evaluate novel pharmaceutical manufacturing technologies to reduce the reliance of the Department on foreign manufacturers for active pharmaceutical ingredients and key starting materials. Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

 

H.R.6895 – To amend the National Defense Authorization Act for Fiscal Year 2023 to extend Federal support for bioindustrial manufacturing processes to include support for the manufacturing of certain pharmaceutical ingredients. Sponsor: Slotkin, Elissa [Rep.-D-MI-7]; Committees: House – Armed Services

 

H.R.6892 – To provide for the coverage of medically necessary food and vitamins and individual amino acids for digestive and inherited metabolic disorders under Federal health programs and private health insurance, to ensure State and Federal protection for existing coverage, and for other purposes. Sponsor: McGovern, James P. [Rep.-D-MA-2]; Committees: House – Energy and Commerce; Ways and Means; Oversight and Accountability; Armed Services

 

H.R.6884 – To increase the minimum levels of financial responsibility for transporting property, and to index future increases to changes in inflation relating to medical care. Sponsor: Garcia, Jesus G. “Chuy” [Rep.-D-IL-4]; Committees: House – Transportation and Infrastructure

 

H.R.6881 – To direct the Federal Trade Commission to establish standards for making publicly available information about the training data and algorithms used in artificial intelligence foundation models, and for other purposes. Sponsor: Beyer, Donald S., Jr. [Rep.-D-VA-8]; Committees: House – Energy and Commerce