Health Care Watch: November 19, 2023
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from November 12 – November 19. 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 12, Ways & Means Health Subcommittee member Brian Higgins (D-NY) announced that he will not run for re-election. On November 16, fellow Committee member Dan Kildee (D-MI) announced his retirement at the end of the Congress.
On November 13, the Rules Committee voted 8-4 to advance the Departments of Labor, Health & Human Services (HHS), and Education funding bills. On November 14, House leadership announced that they will not move forward with the legislation until after the Thanksgiving holiday.
On November 14, the House passed a continuing resolution (CR) to fund certain aspects of the government, including health care policy “extenders,” until January 19 and the military and other large domestic programs being funded through February 2. The legislation passed with a 336-95 vote with 127 Republicans joining 209 Democrats to pass the legislation. The legislation passed the Senate on November 15 in an 87-11 vote.
On November 15, the Energy & Commerce Committee held a markup of legislation aimed at improving patient access to care, supporting providers, and restricting pharmacy benefit managers (PBMs). The committee advanced 21 pieces of legislation. A list of bills discussed and advanced during the mark-up can be found here.
Senate
On November 14, the Finance Health Cubcommittee held a hearing entitled Ensuring Medicare Beneficiary Access: A Path to Telehealth Permanency. The hearing discussed how to make expanded telehealth permanently for Medicare patients.
On November 14, Sens. Raphael Warnock (D-GA) and John Kennedy (R-LA) released a report entitled Insulin Deserts: The Urgency of Lowering the Cost of Insulin for Everyone. The report followed the Senators’ introduction of the Affordable Insulin Now Act of 2023 earlier this year that would cap the cost of insulin in commercial plans at $35 a month. Sen. Warnock stated that he is hoping for a vote on the proposed legislation by the end of the year.
REGULATORY UPDATE
On November 13, the Substance Abuse and Mental Health Services Administration (SAMHSA), released the results of the 2022 National Survey on Drug Use and Health (NSDUH). The report shows how people living in the United States reported about their experience with mental health, substance use, and treatment related behaviors in 2022. A fact sheet detailing the survey can be found here. The Biden Administration’s statement on the findings of the survey can be found here.
On November 13, the Centers for Medicare & Medicaid Services (CMS) announced that the Doctors and Clinicians Preview Period is officially open. Providers can preview their 2022 Quality Payment Program (QPP) performance information before it will appear on clinician and group profile pages on the Medicare.gov compare tool and in the Provider Data Catalog (PDC).
On November 14, CMS, announced Missouri’s extension of comprehensive coverage after pregnancy through Medicaid and the Children’s Health Insurance Program (CHIP) for postpartum individuals for a full 12 months. Missouri is the 40th state to be approved for extended coverage.
On November 15, HHS released the HHS Language Access Plan. In releasing the Language Access Plan, HHS is working to ensure greater access to the life-saving services that it provides for people with Limited English Proficiency (LEP) and people with disabilities.
On November 15, CMS released the Fiscal Year (FY) 2023 Improper Payments Fact Sheet detailing improper payment rates for CMS’ programs in FY2023. The fact sheet states that: 1) Medicare fee-for-service (FFS) estimated improper payment rate was 7.38% ($31.2 billion); 2) Medicare Part C estimated improper payment rate was 6.01% ($16.6 billion); and 3) Medicare Part D estimated improper payment rate was 3.72% ($3.4 billion).
On November 15, CMS released a final rule requiring the disclosure of certain ownership, managerial, and other information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities. The rule requires Medicare SNFs and Medicaid nursing facilities to disclose the following information upon enrolling and revalidating enrollment: (1) each member of the facility’s governing body, including the name, title and period of service of each member; (2) each person or entity who is an officer, director, member, partner, trustee or managing employee of the facility, including the name, title and period of service of each such person or entity; (3) each person or entity who is an additional disclosable party of the facility; and (4) the organizational structure of each additional disclosable party of the facility and a description of the relationship of each such additional disclosable party to the facility and to one another. SNFs must revalidate their Medicare enrollment every five years. The rule also defines the terms “private equity company” and “real estate investment trust,” about which information must be disclosed on the Medicare enrollment application. A fact sheet detailing the final rule can be found here.
On November 15, CMS released the HHS Notice of Benefit and Payment Parameters for 2025 proposed rule. The rule proposes standards for issuers and Marketplaces, as well as requirements for agents, brokers, web-brokers, direct enrollment entities, and assisters that help Marketplace consumers. The proposed rule also includes several proposals impacting the Medicaid program, CHIP, and the Basic Health Program (BHP). A fact sheet detailing the proposed rule can be found here.
On November 16, SAMHSA, announced notices of funding opportunities for grant programs that address behavioral health challenges in local communities by preventing substance use initiation, reducing the progression of substance use, and addressing other related concerns. The grant opportunities total about $74.4 million. Grants include: $30.4 million for Expansion and Sustainability of the Comprehensive Community Mental Health Services for Children with Serious Emotional Disturbances (CMHI), $13.1 million for tribal behavioral health, $15.5 million for Partnerships for Success for States, and $15.5 million for Partnerships for Success for Communities, Local Governments, Universities, Colleges, and Tribes/Tribal Organizations.
On November 16, HHS announced the establishment of the Secretary’s Advisory Committee on Long COVID and invites nominations for the Committee. This Committee is called for in the National Research Action Plan on Long COVID, published in April 2022, to make recommendations on research and innovation in the whole-of-government response to the longer-term impacts of COVID-19. This Committee will bring perspectives from outside the government to help inform action on Long COVID and associated conditions, with a focus on health equity. More information on the Committee can be found here.
On November 16, the Centers for Disease Control and Prevention (CDC) announced the release of more than 77,000 additional doses of Beyfortus (nirsevimab-alip (100 mg)), a long-acting monoclonal antibody designed to protect infants against severe respiratory syncytial virus (RSV) disease. These additional doses will be distributed immediately to physicians and hospitals through the Vaccines for Children Program and commercial channels.
On November 16, Principal Deputy Food 7 Drug Administration (FDA) Commissioner Janet Woodcock announced that she will retire in early 2024.
WHITE HOUSE
On November 13, the Biden Administration announced the White House Initiative on Women’s Health Research. As a first step, President Biden is directing his Administration to: establish the initiative consisting of executive departments and agencies across the Federal government; deliver concrete recommendations to advance women’s health research; take a targeted, high-impact approach; and engage the scientific, private sector, and philanthropic communities. The Initiative will explore new public-private partnerships and engage private and philanthropic leaders to drive innovation and ensure the combined power of public, private, and philanthropic sectors advances research on women’s health.
On November 15, President Biden and Chinese President Xi Jinping announced an agreement to curb the export of chemicals used to make fentanyl from China. Both leaders welcomed the resumption of bilateral cooperation to combat global illicit drug manufacturing and trafficking, including synthetic drugs like fentanyl, and the establishment of a working group for ongoing communication and law enforcement coordination on counternarcotics issues.
On November 15, the Biden Administration hosted a round table with leading rural health care provider and consumer and advocacy organizations to mark National Rural Health Day and discuss the work of the Administration to advance the health and well-being of rural Americans. Participants discussed the importance of the Administration’s commitment to rural health and the opportunities that training more providers, leveraging technology, and supporting rural health care infrastructure offer to help sustain and increase access to care in rural communities.
On November 15, First Lady Jill Biden announced new actions to provide patient navigation support to Americans with cancer. She stated that through the Cancer Moonshot Imitative, the Biden Administration is putting in place billing codes that health insurers – including Medicare – can use to pay for patient navigation services.
On November 16, the White House released several resources to help support federal agencies, states, local and tribal governments to better coordinate health care, public health, and social services. Specifically, the White House released the first ever U.S. Playbook to Address Social Determinants of Health. To accompany this, HHS released a Call to Action to Address Health Related Social Needs, and a Medicaid and CHIP Health-Related Social Needs Framework.
On November 17, President Biden signed H.R. 6363, the Further Continuing Appropriations and Other Extensions Act, 2024, averting a government shutdown and funding the government fully until January 19, 2024, with some programs being funded through February 2, 2024.
On November 17, President Joe Biden announced his intent to appoint Dr. W. Kimryn Rathmell as the Director of the National Cancer Institute (NCI).
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
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
CMS Enforcement of State Compliance with Reporting and Federal Medicaid Renewal Requirements Under Section 1902(tt) of the Social Security Act (CMS-2447); Interim Final Rule; 8/16/23
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
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Final Rule; 9/7/23
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
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 13, OIG released a report examining Pennsylvania nursing homes’ compliance with federal requirements for life safety, emergency preparedness, and infection control. OIG found that Pennsylvania could better ensure that nursing homes in Pennsylvania that participate in the Medicare or Medicaid programs comply with Federal requirements for life safety, emergency preparedness, and infection control if additional oversight was provided. During onsite inspections, OIG identified deficiencies related to life safety, emergency preparedness, or infection control at all 20 nursing homes that were audited, totaling 586 deficiencies. As a result, the health and safety of residents, staff, and visitors at the 20 nursing homes are at an increased risk during a fire or other emergency, or in the event of an infectious disease outbreak. OIG recommends that Pennsylvania follow up with the 20 nursing homes reviewed as part of the audit to verify that corrective actions have been taken regarding the deficiencies identified in this report.
On November 15, OIG released the Top Management and Performance Challenges Facing HHS. The document helps the Department fulfill its mission to enhance the health and well-being of all Americans by directing the Department’s focus on the top management and performance challenges identified by OIG. The report contains 5 sections: 1) safeguarding public health; 2) ensuring the financial integrity of HHS programs; 3) improving outcomes and Medicare and Medicaid; 4) protecting HHS beneficiaries; and 5) securing data and technology. The complete report can be found here.
UPCOMING HEARINGS
House
Ways & Means Committee
TBD
Markup of drug and device legislation and hearing on the status of CMMI
Senate
HELP Committee
Week of December 4 or 11
SUPPORT Act reauthorization markup
December 15, TBD
Hearing on diabetes
TBD
Hearings on not-for-profit hospitals and the pharmaceutical industry