Congress Passes CR, Averting Government Shutdown Until March-Congress successfully passed another two-step stopgap spending bill (H.R. 2872) last week. The measure extends funding deadlines for federal agencies from January 19 and February 2 to March 1 and March 8. The Senate passed the bill in a 77-18 vote on Thursday. The CR was approved by the House of Representatives in a 314-108 vote hours later, and signed by President Joe Biden on Friday. House Speaker Mike Johnson (R-La.) had previously pledged to not pass any additional temporary spending measures, and nearly half the House Republican caucus voted against the bill in opposition to the Speaker’s dealmaking with congressional Democrats and in demand of immigration and border security policy changes. Last week, prior to passage of the CR, Congressional leadership announced bipartisan agreement on a $1.66 trillion topline spending cap for fiscal year (FY) 2024, and lawmakers hope the latest CR will provide enough time to negotiate the details of the 12 annual appropriations bills. Congress faces an effective April 30 deadline to pass appropriations for FY 2024 due to a provision included in the most recent debt ceiling compromise which would impose an automatic across the board spending cut should a CR still be in place at that time. House GOP leadership have announced a change to the chamber’s schedule for next month, deciding to cut their February recess short and hold votes February 28 through March 1.
CMS Releases Final Interoperability and E-Prior Authorization Regulation-The Centers for Medicare and Medicaid Services (CMS) released its final rule on advancing interoperability and improving prior authorization processes last week. The regulation would impose new requirements aimed at enhancing the electronic exchange of health care data and improving prior authorization processes. Provisions in the final rule apply to Medicare Advantage organizations, state Medicaid and Children’s Health Insurance Program (CHIP) fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally Facilitated Exchanges. The rule requires impacted payers to implement an HL7 FHIR Patient Access application programming interface (API), a provider access API, a payer-to-payer API, and a prior authorization API. It also includes provisions to require impacted payers to send prior authorization decisions within 72 hours for urgent requests and seven calendar days for standard requests, to provide a specific reason for denied prior authorization decisions, and to publicly report certain prior authorization metrics on an annual basis. The regulation also adds a new “Electronic Prior Authorization” measure for Merit-based Incentive Payment System eligible clinicians and hospitals, including critical access hospitals. The regulation was praised by the congressional champions of the Improving Seniors’ Timely Access to Care Act, who stated that the regulation will “make a big difference in helping seniors access the medical care they are entitled to without unnecessary delays and denials.” Rep. Suzan DelBene (D-Wash.) explained that although the rule address many of the things that were in the bill, there are areas where CMS “could have gone further, especially in terms of speed of decision-making.” She and the other bill sponsors plan to review the final rule and “see what else we can do legislatively to not only solidify and codify what is in the rule, but also look at what we can do to try to increase speed of responses.”
HELP to Vote on Prescription Drug Pricing Investigation-The Senate Health, Education, Labor, and Pensions (HELP) Committee is set to vote on January 31 to authorize an investigation into the high costs of prescription drugs. The panel will also vote on subpoenaing the CEOs of Johnson & Johnson and Merck to testify about why the manufacturers charge “substantially higher prices for medicine in the U.S. compared to other countries.” Chairman Bernie Sanders (I-Vt.) will need a majority of his panel to vote in support of the subpoenas. If he is successful, it will be the first time the committee has subpoenaed anyone in more than 40 years.
Biden Administration Drops Appeal on the Copay Accumulator Decision-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. The decision was praised by many lawmakers on Capitol Hill, including Sens. Tim Kaine (D-Va.) and Roger Marshall (R-Kan.) and Reps. Buddy Carter (R-Ga.), Nanette Barragan (D-Calif.), and Mariannette Miller-Meeks (R-Iowa), who had urged the administration to drop its appeal and introduced the HELP Copays Act (S. 1375/H.R. 830), which would prohibit the use of copay accumulator programs. Nineteen states have already acted to ban copay accumulator adjustment programs.
Schatz Leads Bipartisan Letter on Permanent Telehealth Flexibilities-A bipartisan group of senators led by Sen. Brian Schatz (D-Hawaii) have sent a letter to the U.S. Department of Health and Human Services (HHS) urging the administration to work with Congress to ensure that all Medicare beneficiaries have permanent access to telehealth services. Temporary COVID-era waivers expanding access to telehealth are currently set to expire on December 31, 2024. The letter urges Secretary Xavier Becerra to communicate to Congress and the public the authorities, appropriations, resources, and other supports needed to enact permanent telehealth legislation. The lawmakers also encourage HHS to solicit information from stakeholders to address any outstanding implementation questions related to permanent policy.
ARPA-H to Solicit Rural Care Proposals-The Advanced Research Projects Agency for Health (ARPA-H) has launched a program to increase access to early disease detection and hospital level care in rural areas of the country. The Platform Accelerating Rural Access to Distributed & Integrated Medical care (PARADIGM) program aims to support the development of mobile health units to extend the reach of rural hospitals. A forthcoming PARADIGM program solicitation will solicit proposals from a wide range of applicants with proposals for bringing advanced medical services to underserved rural populations throughout the country. More information about the PARADIGM program and the scheduled Proposers’ Day to be held the week of February 12 can be found here.
FDA, CMS Issue Joint Statement on Regulation of LDTs-The Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) issued a joint statement last week reiterating mutual support for FDA oversight of the analytical and clinical validity of laboratory developed tests (LDTs). The statement acknowledges the concerns that have been raised about the safety and effectiveness of LDTs, and responds to the suggestion that these concerns should be addressed through the expansion of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). “The FDA and CMS have long stood together in mutual support of FDA oversight of the analytical and clinical validity of LDTs,” the statement reads. “Applying the same oversight approach to laboratories and non-laboratories that manufacture tests would better assure the safety and effectiveness of LDTs and would remove a disincentive for non-laboratory manufacturers to develop novel tests that can be available to and used by many laboratories for many patients.”
Congressional Retirements and Resignations-Rep. Jeff Duncan (R-S.C.) announced his retirement last week. Duncan was first elected to Congress in 2010, and currently sits on the Energy and Commerce Committee.
House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) announced the selection of Rep. Buddy Carter (R-Ga.) to replace Rep. Bill Johnson (R-Ohio) as Chair of the Environment, Manufacturing, and Critical Materials Subcommittee. Johnson resigned from Congress effective this week to start as President at Youngstown State University.
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 |
| Phillips (D), MN | Bucshon (R), IN |
| Cardenas (D), CA | Pence (R), IN |
| Eshoo (D), CA | Duncan (R), SC |
| Manning (D), NC | |
| Higgins (D), NY (effective Feb. 2, 2024) | |
| Nickel (D), NC | |
Upcoming Congressional Hearings and Markups
Senate Judiciary Subcommittee on Intellectual Property hearing to examine the Patent Eligibility Restoration Act, focusing restoring clarity, certainty, and predictability to the U.S. patent system; 2:30 p.m.; January 23
Senate Committee on Environment and Public Works oversight hearing to examine the Toxic Substances Control Act amendments implementation; 10:00 a.m.; January 24
Senate Special Committee on Aging hearing “Assisted Living Facilities: Understanding Long-Term Care Options for Older Adults;” 10:00 a.m.; January 25
House Veterans’ Affairs Subcommittee on Technology Modernization hearing “The Future of Data Privacy and Artificial Intelligence at VA;” 3:30 p.m.; January 29
Senate Health, Education, Labor, and Pensions Committee executive session to authorize an investigation into the high costs of prescription drugs for patients in the United States compared to other countries; 11:00 a.m.; January 31
Recently Introduced Health Legislation
H.R.6986-To address patent thickets; Sponsor: Arrington, Jodey C. [Rep.-R-TX-19]; Committees: House-Judiciary
H.R.6992-To require the Secretary of Health and Human Services to establish a list of essential medicines, and for other purposes; Sponsor: Matsui, Doris O. [Rep.-D-CA-7]; Committees: House – Energy and Commerce
H.R.6993-To allow individuals to choose to opt out of the Medicare part A benefit; Sponsor: Palmer, Gary J. [Rep.-R-AL-6]; Committees: House – Ways and Means
S.3597-A bill to reauthorize programs relating to oral health promotion and disease prevention; Sponsor: Durbin, Richard J. [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions
S.3598-A bill to require the Secretary of Veterans Affairs to establish a comprehensive standard for timing between referrals and appointments for care from the Department of Veterans Affairs and to submit a report with respect to that standard, and for other purposes; Sponsor: Scott, Rick [Sen.-R-FL]; Committees: Senate – Veterans’ Affairs
S.3607-A bill to amend the Internal Revenue Code of 1986 to provide that amounts paid for an abortion are not taken into account for purposes of the deduction for medical expenses; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate-Finance
S.3608-A bill to amend the Internal Revenue Code of 1986 to prohibit treatment of certain distributions and reimbursements for certain abortions as qualified medical expenses; Sponsor: Lee, Mike [Sen.-R-UT]; Committees: Senate-Finance
H.R.7002-To provide for a wage differential program to support new nursing school faculty members; Sponsor: Bonamici, Suzanne [Rep.-D-OR-1]; Committees: House – Energy and Commerce
H.R.7014-To amend title XIX of the Social Security Act to prohibit Federal Medicaid funding for the administrative costs of providing health benefits to individuals who are unauthorized immigrants; Sponsor: Hudson, Richard [Rep.-R-NC-9]; Committees: House – Energy and Commerce
H.R.7017-To amend the Internal Revenue Code of 1986 to take certain Medicare premiums of household members into account in determining the health care insurance premiums tax credit; Sponsor: Levin, Mike [Rep.-D-CA-49]; Committees: House – Ways and Means
S.3609-A bill to ensure that women seeking an abortion are informed of the medical risks associated with the abortion procedure and the major developmental characteristics of the unborn child, before giving their informed consent to receive an abortion; Sponsor: Blackburn, Marsha [Sen.-R-TN]; Committees: Senate – Health, Education, Labor, and Pensions
S.3612-A bill to prohibit the limitation of access to assisted reproductive technology, and all medical care surrounding such technology; Sponsor: Duckworth, Tammy [Sen.-D-IL]; Committees: Senate – Health, Education, Labor, and Pensions
S.3621-A bill to amend the Federal Food, Drug, and Cosmetic Act to establish nonvisual accessibility standards for certain devices with digital interfaces, and for other purposes; Sponsor: Hassan, Margaret Wood [Sen.-D-NH]; Committees: Senate – Health, Education, Labor, and Pensions
S.3628-A bill to amend title XVIII of the Social Security Act to improve mobility crisis under the Medicare program; Sponsor: Cortez Masto, Catherine [Sen.-D-NV]; Committees: Senate-Finance
S.3630-A bill to amend title XI of the Social Security Act to establish a pilot program for testing the use of a predictive risk-scoring algorithm to provide oversight of payments for durable medical equipment and clinical diagnostic laboratory tests under the Medicare program; Sponsor: Braun, Mike [Sen.-R-IN]; Committees: Senate-Finance
H.Res.976-Recognizing the roles and the contributions of Americas Certified Registered Nurse Anesthetists (CRNAs) and their critical role in providing quality health care for the public and the Nations Armed Forces for more than 150 years, through multiple public health emergencies, and beyond; Sponsor: Schakowsky, Janice D. [Rep.-D-IL-9]; Committees: House – Energy and Commerce
H.R.7044-To ensure that women seeking an abortion are notified, before giving informed consent to receive an abortion, of the medical risks associated with the abortion procedure and the major developmental characteristics of the unborn child; Sponsor: McClain, Lisa C. [Rep.-R-MI-9]; Committees: House – Energy and Commerce
H.R.7049-To repeal the Department of Veterans Affairs directive relating to the COVID-19 vaccination program for Veterans Health Administration health care personnel, and for other purposes; Sponsor: Roy, Chip [Rep.-R-TX-21]; Committees: House – Veterans’ Affairs
H.R.7050-To amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the substance use disorder crisis; Sponsor: Schneider, Bradley Scott [Rep.-D-IL-10]; Committees: House – Ways and Means; Energy and Commerce
H.R.7056-To prohibit the limitation of access to assisted reproductive technology, and all medical care surrounding such technology; Sponsor: Wild, Susan [Rep.-D-PA-7]; Committees: House – Energy and Commerce