Health Care Watch: December 2, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 26 – December 2. 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 November 29, the Budget Committee held a hearing entitled Examining the Need for a Fiscal Commission Reviewing H.R. 710, H.R. 5779, and S. 3262. The hearing examined bicameral, bipartisan proposals to create a fiscal commission to study and provide policy solutions on the growing deficit. Sens. Mitt Romney (R-UT) and Joe Manchin (D-WV) along with a panel of House members discussed their independent fiscal commission proposals.
On November 29, the Energy & Commerce Health Subcommittee held a hearing entitled Understanding How AI Is Changing Health Care. The hearing included testimony from expert witnesses and a discussion of potential regulatory action and payment structures to be implemented as AI technology in health care continues to expand.
On November 29, Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA) sent a letter to Centers for Disease Control and Prevention (CDC) Director Mandy Cohen, who testified before the Oversight Subcommittee on November 30. The letter stated that the CDC’s “failure to communicate accurate information in real-time during the COVID-19 pandemic has undermined public trust in the agency. If the CDC is to regain credibility with the American people, it must be transparent and forthcoming with the information it has on public health threats facing our nation.” Director Cohen’s full testimony can be found here.
REGULATORY UPDATE
On November 27, the Food & Drug Administration (FDA) approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.
On November 28, FDA announced an investigation into a possible link between patients developing new cancers after undergoing CAR-T therapy. FDA has received reports of T-cell malignancies, including CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell therapies. Reports were received from clinical trials and/or postmarketing adverse event (AE) data sources. FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed CAR T cell therapies.
On November 29, FDA Commissioner Robert Califf announced that chief scientist Dr. Namandjé Bumpus will become Principal Deputy Commissioner early next year after Dr. Janet Woodcock retires.
On November 29, the Department of Education (ED) and the Department of Health and Human Services’ (HHS’) Administration for Strategic Preparedness and Response (ASPR), announced a partnership to distribute free COVID-19 tests to schools across the country. In a letter sent to local education agencies by ED, school districts are being encouraged to order tests directly from the federal government to be made available to students, parents, staff, and school communities.
On November 29, the Centers for Medicare & Medicaid Services (CMS) announced the implementation of 41 new procedure codes into the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS), effective April 1, 2024. More information regarding the procedure codes can be found here.
On November 29, CMS announced an extension of the application deadline for the Making Care Primary (MCP) Model until December 14, 2023. The MCP Model is a voluntary, 10.5-year, multi-payer model that will run from July 2024 to December 2034, building on previous Centers for Medicare and Medication Innovation (CMMI) primary care models. More information on the model is available here.
On November 29, CMS announced that North Carolina’s Medicaid expansion will offer nearly 600,000 adults aged 19 to 64 who make less than $20,120 annually comprehensive health coverage through Medicaid.
WHITE HOUSE
On November 27, President Biden announced actions to strengthen America’s supply chains, lower costs for families, and secure key sectors. Actions include: the creation of the Council on Supply Chain Resilience, the use of the Defense Production Act (DPA) to make more essential medicines in America and mitigate drug shortages, new cross-governmental supply chain data-sharing capabilities, and additional actions aimed at supporting stronger supply chains and access to affordable, reliable energy and critical technology. Additionally, President Biden will issue a Presidential Determination to broaden HHS authorities under DPA to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and critical inputs that have been deemed by the President as essential to the national defense. HHS has identified $35 million for investments in domestic production of key starting materials for sterile injectable medicines and will also designate a new Supply Chain Resilience and Shortage Coordinator.
On November 28, senior Biden Administration officials met with suppliers to discuss the manufacturing, distribution, and accessibility of RSV immunizations through the private market. Senior administration officials underscored the importance of manufacturers such as Sanofi and AstraZeneca working to meet demand with a sense of urgency the winter season commences. During the meeting, manufacturers and senior administration officials also agreed on proactive planning now to meet next year’s projected demand for immunizations.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
ASPR
Health Resources Priority and Allocations System (HRPAS); Final Rule; 11/17/23
CMS
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326); Final Rule; 7/31/23
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; 12/27/22
Appeal Rights for Certain Changes in Patient Status (CMS-4204); Proposed Rule; 9/18/23
Interoperability and Prior Authorization for MA Organizations, Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers, MIPS Eligible Clinicians, Eligible Hospitals and CAHs (CMS-0057); Final Rule; 10/25/23
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
Federal Independent Dispute Resolution Process Fees (CMS-9890); Final Rule; 11/14/23
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
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability (CDER, 2023-357); Notice; 10/23/23
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability (CDER, 2023-356): Notice; 10/23/23
Menu Labeling: Supplemental Guidance for Industry (Edition 2); Draft Guidance for Industry; Notice; 10/31/23
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry; Availability; Notice; 11/8/23
Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization; Notice; 11/27/23
OCR
Safeguarding the Rights of Conscience as Protected by Federal Statutes; Final Rule; 9/15/23
Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing; Final Rule’ 10/19/23
SAMHSA
Medications for the Treatment of Opioid Use Disorder; Final Rule; 10/24/23
IHS
Calendar Year 2024 Reimbursement Rates Notice; Notice; 11/10/23
REPORTS
Office of Inspector General (OIG)
On November 27, OIG released a report examining the risk of misuse and diversion of buprenorphine for opioid use disorder in Medicare Part D. OIG found that almost all Part D enrollees who received buprenorphine for the treatment of opioid use disorder received the recommended amounts in 2022. OIG stated that the findings suggest that the risk of misuse and diversion of buprenorphine in Part D continues to be low.
On November 28, OIG released a report examining Medicaid capitation payments to managed care organizations (MCOs) after enrollees’ deaths. OIG identified more than $249 million ($172 million Federal share) in unallowable Medicaid capitation payments that the States made to MCOs on behalf of deceased enrollees. OIG recommends that CMS: 1) collect the outstanding unallowable payments totaling the estimated $41,003,804 previously identified; 2) ensure that States complete actions on remaining recommendations to address the internal control weaknesses OIG identified; and 3) continue to explore opportunities for using Transformed Medicaid Statistical Information System (T-MSIS) and Social Security Administration's (SSA's) Death Master File (DMF) data to improve its oversight of the Medicaid program.
On November 28, OIG released a report examining Medicare Part B payment amounts for Tezspire. OIG determined that the Part B payment amount for the drug Tezspire included a noncovered self-administered version and a covered provider-administered version beginning in July 2023. OIG is issuing this early alert brief so that CMS can remove the self-administered version of Tezspire from payment amount calculations in subsequent quarters if the exclusion would result in lower payment amounts. OIG will conduct a full assessment of billing codes in 2023 to determine if there are any additional codes for which self-administered versions and provider-administered versions were used to set payment amounts that year.
On November 30, OIG released its semi-annual report to Congress. The report describes OIG's work identifying significant risks, problems, abuses, deficiencies, remedies, and investigative outcomes relating to the administration of HHS programs from April 1, 2023 – September 30, 2023. The report found that during this period, OIG issued 65 audit reports and 22 evaluation reports, identified $82.7 million in expected recoveries and $1.2 billion in questioned costs, and identified $47.2 million in potential savings for HHS. The full report can be found here.
Government Accountability Office (GAO)
On November 30, GAO released a report examining CMS’ plans for including phosphate binders in the bundled payment for end-stage renal disease (ESRD). GAO found that all dialysis organization representatives interviewed by GAO anticipate needing to expand their existing capacity to dispense oral drugs. GAO stated that they attributed this need, in part, to the high volume of phosphate binder prescriptions. In addition, dialysis organization representatives expressed concerns that the modified bundled payment may not fully account for the costs of acquiring, shipping, and dispensing phosphate binders. GAO stated that CMS plans to monitor beneficiary utilization of phosphate binders and health outcomes related to phosphate binder treatment once these drugs are included in the bundled payment.
UPCOMING HEARINGS
House
Energy & Commerce Committee
December 4; 2:00 PM; 2123 Rayburn
Markup of 44 bills including:
H.R. 2365, National Plan to End Parkinson’s Act;
H.R. 5372, Expanding Seniors’ Access to Lower Cost Medicines Act of 2023;
H.R. 2880, Protecting Patients Against PBM Abuses Act;
H.R. 5393, To amend title XVIII of the Social Security Act to ensure fair assessment of pharmacy performance and quality under Medicare part D, and for other purposes;
H.R. 5385, Medicare PBM Accountability Act;
H.R. 5386, Cutting Copays Act;
H.R. 4881, To amend title XVIII of the Social Security Act to limit cost sharing for drugs under the Medicare program;
H.R. 5389, National Coverage Determination Transparency Act, as amended;
H.R. 133, Mandating Exclusive Review of Individual Treatments (MERIT) Act;
H.R. 5396, Coverage Determination Clarity Act of 2023;
H.R. 5371, Choices for Increased Mobility Act of 2023;
H.R. 5388, Supporting Innovation for Seniors Act;
H.R. 5380, To amend title XVIII of the Social Security Act to increase data transparency for supplemental benefits under Medicare Advantage;
H.R. 3842, Expanding Access to Diabetes Self-Management Training Act of 2023, as amended;
H.R. 5397, Joe Fiandra Access to Home Infusion Act of 2023, as amended;
H.R. 6366, To amend title XVIII of the Social Security Act with respect to the work geographic index for physician payments under the Medicare program and to revise the phase-in of clinical laboratory test payment changes under such program;
H.R. 6369, To amend title XVIII of the Social Security Act to extend incentive payments for participation in eligible alternative payment models;
H.R. 5555, DMEPOS Relief Act of 2023;
H.R. 6545, Physician Fee Schedule Update and Improvements Act;
H.R. 6364, Medicare Telehealth Privacy Act of 2023; and
H.R. 1352, Increasing Access to Biosimilars Act of 2023.
Oversight and Accountability Committee
December 6; 2:00 PM; 2154 Rayburn
Senate
Finance Committee
December 5; 10:00 AM; 215 Dirksen
Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective
Witnesses: Inmaculada Hernandez, Professor, Division of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego; Marta Wosińska, Senior Fellow, Schaeffer Initiative on Health Policy, The Brookings Institution; Allan Coukell, Senior Vice President of Public Policy, Civica Rx; Jason Westin, MD, Director, Lymphoma Clinical Research Program, Section Chief, Aggressive Lymphoma, Department of Lymphoma & Myeloma, M.D. Anderson Cancer Center.
Appropriations Committee
December 8; 9:00 AM; 106 Dirksen
A Review of the President’s Supplemental Request for the Departments of Health and Human Services and Homeland Security
Witnesses: Xavier Becerra, Secretary, Department of Health and Human Services; Alejandro Mayorkas, Secretary, Department of Homeland Security
HELP Committee
December 12
SUPPORT Act reauthorization markup
December 15, TBD
Hearing on diabetes
TBD
Hearings on not-for-profit hospitals and the pharmaceutical industry
January 25; 10:00 AM
Why Does the United States Pay, By Far, The Highest Prices in the World for Prescription Drugs?
OTHER POLICY NEWS
On November 27, the Medicare Payment Advisory Commission (MedPAC) announced that it will hold its monthly meetings on December 7 and 8. The Commission will focus on provider payment adequacy. The agenda can be found here.
On November 27, former President Donald Trump announced that he plans to try and repeal the Affordable Care Act should he be re-elected.