Health Care Watch: January 21, 2024
he following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from January 14 – January 21. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
LEGISLATIVE UPDATE
House
On January 17, Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-WA) announced that the committee’s investigation into the origins of COVID-19 uncovered that a SARS-CoV-2 sequence was submitted to GenBank, the National Institutes of Health’s (NIH) genetic sequence database operated by the National Center for Biotechnology Information (NCBI), on December 28, 2019—two weeks before the Chinese Center for Disease Control and Prevention (China CDC) first released the virus’s sequence. The letter maintains that the existence of this sequence days before the Chinese Communist Party (CCP) acknowledged an outbreak, and more than two weeks before the China CDC release their sequence, calls into question how early the CCP knew about the virus and how long they withheld this information from the world, resulting in more deaths and wasting critical time to develop vaccines and treatments.
On January 17, Energy & Commerce Committee member Jeff Duncan (R-SC) announced that he will not seek re-election.
On January 18, the House passed a stopgap funding bill, H.R. 2872, the Further Additional Continuing Appropriations and Other Extensions Act of 2024, in a 314-108 vote, averting a government shutdown. The legislation was passed by the Senate earlier that day in a 77-18 vote. The continuing resolution (CR) keeps the laddered approach of the current CR and extends Agriculture-FDA, Energy-Water, Military Construction-VA, and Transportation-HUD funding to March 1, with the remaining Departments, including health care “extenders,” funded through March 8. President Biden signed the bill on January 19.
The House will return to session on January 29.
Senate
On January 16, Special Committee on Aging Chairman Bob Casey (D-PA) sent letters to the CEOs of three of the largest corporate owners of assisted living facilities—Atria Senior Living, Brookdale Senior Living, and Sunrise Senior Living. The letters address concerns about workforce shortages and expensive and inadequate care in assisted living facilities raised by recent reporting in the Washington Post and New York Times. In the letters, Chairman Casey requests a series of information from the companies about these concerns. In addition to sending the letters, Chairman Casey will hold an Aging Committee hearing on January 25th entitled Assisted Living Facilities: Understanding Long-Term Care Options for Older Adults.
On January 17, Health, Education, Labor & Pensions (HELP) Committee Ranking Member Bill Cassidy (R-LA) sent letters to CVS Health and Walgreens seeking information on how the retail pharmacies use and generate revenue from the federal government’s 340B Drug Pricing Program. The letters come as part of an ongoing investigation into how health care entities use and generate revenue from the 340B program.
On January 18, the HELP Committee held a hearing entitled Addressing Long COVID: Advancing Research and Improving Patient Care. The hearing included testimony from long COVID patients and health care specialists and examined ways to treat, research, address, and increase funding for long-COVID initiatives.
On January 18, HELP Committee Chairman Bernie Sanders (I-VT) announced that on January 31 the committee will hold votes to issue subpoenas for Johnson & Johnson CEO Joaquin Duato and Merck CEO Robert Davis to provide testimony about high drug prices and the companies’ pricing strategies. If authorized, these would be the first subpoenas issued by the HELP Committee since 1981.
On January 19, a group of bipartisan lawmakers, led by Sen. Brian Schatz (D-HI) and Roger Wicker (R-MS), sent a letter to Department of Health & Human Services (HHS) Secretary Xavier Becerra asking the department to prioritize telehealth and work with Congress to make pandemic-era expanded telehealth access permanent. The letter calls for HHS to provide timely technical assistance and data-sharing and to address potential implementation questions.
REGULATORY UPDATE
On January 16, HHS dismissed its appeal of the U.S. District Court for the District of Columbia decision to overturn the 2021 Notice of Benefit and Payment Parameters final rule that would have permitting plans to not count copay assistance from manufacturer and non-profit copay assistance programs toward maximum out-of-pocket limits (so-called copay accumulators). The plaintiffs in the original lawsuit, the HIV + Hepatitis Policy Institute, hope that dropping the appeal indicates that HHS will now enforce the earlier 2020 policy that barred use of copay accumulators.
On January 16, the Advanced Research Projects Agency for Health (ARPA-H) launched the Platform Accelerating Rural Access to Distributed & InteGrated Medical care (PARADIGM) program. PARADIGM will enhance early detection and management of illness and disease in rural communities across the nation. PARADIGM aims to create a multi-functional, rugged electric vehicle platform that integrates many different medical devices to treat a large variety of health conditions. The program will do this by building software that will connect on-board and remote medical devices with any electronic health record system. The program also is exploring the creation of mini CT-scanners and digitally-enhanced real-time training tools to upskill healthcare workers to perform tasks beyond their usual training. PARADIGM will be using a program solicitation focused on five technical areas: Decentralized Approach to Hospital-Level Care, Care Delivery Platform Integration, Medical IoT Platform, Ruggedized CT Scanner, and Intelligent Task Guidance.
On January 16, the Centers for Medicare & Medicaid Services (CMS) announced that the Skilled Nursing Facility (SNF) Provider Preview Reports have been updated and are now available. These reports contain provider performance scores for quality measures, which will be published on Care Compare and Provider Data Catalog (PDC)during the April 2024 refresh.
On January 16, CMS announced that a public release of the data submitted to CMS as part of the Acute Hospital Care at Home initiative will now be available. CMS plans to release data through the Research and Data Assistance Center (ResDAC), collected from November 27, 2020, through March 30, 2023. Individuals interested in obtaining the CMS data will need to request the available data through ResDAC with an approved Data Use Agreement. More information on how to obtain data can be found here.
On January 16, the Food & Drug Administration (FDA) approvedCasgevy, a cell-based gene therapy, for the treatment of patients 12 years of age and older with transfusion-dependent beta-thalassemia, an inherited disorder characterized by life-long anemia requiring frequent blood transfusions. This application received Fast Track andRegenerative Medicine Advanced Therapy (RMAT) designations. The approval signifies a second FDA-approved indication for Casgevy, as the product was also recently approved for the treatment of sickle cell disease in patients 12 years and older.
On January 17, CMS finalized the Interoperability and Prior Authorization Final Rule (CMS-0057-F). The rule sets requirements for Medicare Advantage (MA) organizations, Medicaid and the Children’s Health Insurance Program (CHIP) fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and issuers of Qualified Health Plans (QHPs) offered on the Federally-Facilitated Exchanges (FFEs) to improve the electronic exchange of health information and prior authorization processes for medical items and services. Beginning on January 1, 2027, impacted payers will be required to build and maintain application programming interfaces (APIs) that will help automate the process for providers to determine whether a prior authorization is required, identify prior authorization information and documentation requirements, and facilitate the exchange of prior authorization requests and decisions from their electronic health records or practice management system. Beginning in 2026, payers must provide a specific reason for denied prior authorization decisions, regardless of the method used to send the prior authorization request. Under the rule, payers must send prior authorization decisions within 72 hours for expedited (i.e., urgent) requests and seven calendar days for standard (i.e., non-urgent) requests. Payers must also add information about prior authorizations (excluding those for drugs) via a Patient Access API. A fact sheet detailing the final rule can be found here.
On January 17, CMS reopened the comment period on a draft rule that aims to streamline and improve the No Surprises Act independent dispute resolution (IDR) process to give stakeholders more time to offer feedback. The comment period will be open for 14 days after the notice is published in the Federal Register on January 22, with comments now due on February 5. Comments can be made here.
On January 17, CMS announced the first 2024 National Stakeholder Call with CMS administrators. The call will include discussion from CMS administrator Chiquita Brooks-LaSure and her leadership team, who will highlight CMS’ key 2023 accomplishments and look ahead to how CMS’s 2024 priorities will advance the CMS Strategic Plan. The call will take place on January 23 from 1:00 PM to 2:00 PM ET. Registration can be found here.
On January 18, CMS’ Center for Medicare & Medicaid Innovation (CMMI) announced the Innovation in Behavioral Health (IBH) Model. The model’s goal is to improve the overall quality of care and outcomes for adults with mental health conditions and/or substance use disorder by connecting them with the physical, behavioral, and social supports needed to manage their care. Under IBH, community-based behavioral health practices will form interprofessional care teams consisting of behavioral and physical health providers, as well as community-based supports. CMS will release a Notice of Funding Opportunity for the IBH Model this spring, and the model will launch in fall 2024. CMS anticipates that the model will operate for eight years in up to eight states. A fact sheet detailing the model can be found here.
On January 18, HHS through the Indian Health Service (IHS), awarded$55 million in funding to 15 tribes and tribal organizations as part of the competitive Small Ambulatory Program to invest in the construction, expansion, or modernization of small ambulatory health care facilities.
On January 18, FDA and CMS issued a joint statement regarding laboratory-developed test (LDTs) regulations. The statement highlights that CMS supports FDA’s proposal to subject tests developed and used within a single laboratory to greater oversight.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Healthcare System Resiliency and Modernization (CMS-3426); Proposed Rule; 10/12/23
Alternative Payment Model Updates; Increasing Organ Transplant Access (IOTA) Model (CMS-5535); Proposed Rule; 11/9/23
Advance Notice of Methodological Changes for Calendar Year 2025 for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies & Draft CY 2025 Part D Redesign Program Instructions; Proposed Rule; 12/1/23
Disproportionate Share Hospital (DSH) Third Party Payer (CMS-2445); Final Rule; 12/8/23
Streamlining the Medicaid, CHIP, and BHP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421); Final Rule’ 12/19/23
Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (CMS-2439); Final Rule; 12/20/23
FDA
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act; Proposed Rule; 8/29/23
Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products; Revised Draft Guidance for Industry (CDER, 2023-36); Notice; 12/1/23
OCR
Confidentiality of Substance Use Disorder Patient Records; Final Rule; 12/4/23
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
REPORTS
Government Accountability Office (GAO)
On January 16, GAO released a report examining the Administration for Strategic Preparedness and Response (ASPR)'s workforce planning. GAO found that ASPR has not identified critical areas in the agency that need workforce assessments nor developed a plan to conduct them. GAO stated that it has also not conducted an agency-wide workforce assessment to prioritize the skills and competencies of greatest need to achieve the agency's goals and mission. GAO recommends that that ASPR: 1) establish specific goals and performance measures to use for its new hiring office once it is fully operational; 2) develop tailored strategies for recruiting and hiring human capital staff for the new office; 3) identify the critical areas that need workforce assessments and develop plans to implement them; and 4) conduct an agency-wide workforce assessment. HHS neither agreed nor disagreed with the first two recommendations and agreed with the last two recommendations.
UPCOMING HEARINGS
Senate
HELP Committee
January 31; 11:00 AM; SD-430
Authorization for Investigation into the High Costs of Prescription Drugs and Related Subpoenas
Authorizations: Subpoena of Joaquin Duato, Chief Executive Officer, Johnson & Johnson; Subpoena of Robert Davis, Chief Executive Officer, Merck.
Special Committee on Aging
January 25; 10:00 AM; SD-106
Assisted Living Facilities: Understanding Long-Term Care Options for Older Adults
OTHER POLICY NEWS
On January 16, the Canadian Minister of Health released a statementon FDA’s approval of drug importation from Canada. The statement expresses disappointment with FDA’s decisions and advises that Canada take all necessary measures to protect the Canadian drug supply.