Health Care Watch: March 2, 2024
The following Federal Health Policy (FHP) Strategies Weekly Health Care Watch provides a summary of legislative and regulatory health care activities from February 25 – March 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 February 28, Congressional leaders reached a government funding deal on six annual spending bills alongside a stopgap bill that pushes the current March 1 continuing resolution (CR) deadline to March 8 and the current March 8 deadline to March 22. Leadership has come to an agreement on six bills: (1) Agriculture-FDA; (2) Commerce-Justice and Science; (3) Energy and Water Development; (4) Interior; (5) Military Construction-VA; and (6) Transportation-HUD. After preparing final text, this package of six full year Appropriations bills will be voted on and enacted prior to March 8. The remaining six Appropriations bills – Defense; Financial Services and General Government; Homeland Security; Labor-HHS; Legislative Branch; and State and Foreign Operations - will be finalized, voted on, and enacted prior to March 22. Leaders hope to release text of the annual spending bills by this weekend and clear the spending bills next week, funding those agencies through September.
On February 29, the House passed the stopgap funding bill that pushes funding deadlines to March 8 and 22 in a 320 to 99 vote. The Senate passed the bill shortly after in a 77-13 vote. On March 1, President Biden signed this legislation it law, averting a partial government shutdown.
On March 5, the House will consider the following bills under Suspension of the Rules:
H.R. 3838, the Preventing Maternal Deaths Reauthorization Act of 2023, which would reauthorize funding for state-based maternal mortality review committees through FY2028;
H.R. 3836, the Medicaid Primary Care Improvement Act, which would allow states to pay a fixed fee for certain primary care services;
H.R. 3843, the Action for Dental Health Act, which would reauthorize funding for dental workforce grants; and
S. 206, the END FENTANYL Act, which would reform policies relating to inspections at ports of entry to the U.S.
Senate
On February 27, Sen. Tammy Duckworth (D-IL) asked for unanimous consent on the Senate floor for her legislation, H.R.7056, the Access to Family Building Act which would federally protect in-vitro fertilization and other fertility treatments. Consideration of the legislation was blocked.
On February 28, Republican Leader Mitch McConnell (R-KY) announced that he will not run for another term as leader. Leader McConnell has served as party leader since 2007, the longest stint in Senate history.
REGULATORY UPDATE
On February 26, the Department of Health & Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced $36.9 million in notices of funding opportunities for grant programs supporting behavioral health services across the country. Additionally, the Centers for Medicare & Medicaid Services (CMS) issued guidance that allows states to expand the pool of behavioral health care providers eligible for enhanced federal Medicaid funding, which will better support the critical workforce as well as improve access to care. The guidance also allows states to claim federal dollars for nurse advice lines. A list of all grant funding opportunities can be found here.
On February 26, OIG released a favorable advisory opinion regarding the use of a "preferred hospital" network as part of Medicare Supplemental Health Insurance ("Medigap") policies, whereby an insurance company would contract with a preferred hospital organization to provide discounts on the otherwise-applicable Medicare inpatient deductible for its policyholders and, in turn, would provide a premium credit of $100 off the next renewal premium to policyholders who use a network hospital for an inpatient stay.
On February 27, the Department of Justice (DOJ) launched an antitrust investigation into UnitedHealth Group. Investigators have been interviewing healthcare industry representatives in sectors where UnitedHealth competes, including doctor groups. During their interviews, investigators have asked about issues including certain relationships between the company's UnitedHealthcare insurance unit and its Optum health services arm.
On February 27, CMS announced a webinar to educate providers of current changes and to help providers to achieve a full Annual Payment Update (APU) in the Skilled Nursing Facility (SNF) Quality Reporting Program (QRP). The webinar will take place on March 26 from 1:00 to 2:30 PM ET. Registration can be found here.
On February 27, the Food & Drug Administration (FDA) announced that it will convene a meeting of its Vaccines and Related Biological Products Advisory Committee on May 16, 2024. During the meeting, the panel will discuss recommendations regarding which variants the 2024-2025 COVID-19 vaccine should target.
On February 27, HHS, through the Administration for Community Living (ACL), announced new initiatives and resources from ACL’s Direct Care Workforce (DCW) Strategies Center to address the shortage of professionals who provide the services many older adults and people with disabilities need to live in the community. Initiatives include: (1) a national hub to connect states, stakeholders and communities to best practices and other resources related to the direct care workforce; and (2) a webinar series for states and stakeholders focused on a range of direct care workforce topics.
On February 27, HHS’s Office on Women’s Health (OWH) announced that it has awarded prizes to the winners in the final phase of the Reducing Disparities in Breastfeeding Innovation Challenge. The national competition was created to identify and reward programs that increase breastfeeding initiation and continuation rates – and decrease disparities – among breastfeeding mothers in the United States. A list of all winners can be found here.
On February 28, HHS released a readout of HHS Secretary Xavier Becerra’s meeting with Director-General of the World Health Organization (WHO) Dr. Tedros Ghebreyesus regarding the current pandemic accord negotiations. During the call, Secretary Becerra stressed the importance of establishing a global agreement that would make America and the world better prepared in the future, and they agreed to continue working together to find common ground.
On February 28, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted 11-1, with one abstention, to recommend that people 65 and older receive an additional dose of the COVID-19 vaccine’s current formulation.
On February 28, HHS Assistant Secretary for Health Admiral Rachel Levine and members of the National Syphilis and Congenital Syphilis Syndemic Federal Task Force (Task Force) met with leaders from national provider organizations. The meeting builds upon a series of conversations and engagements to respond to the U.S. syphilis and congenital syphilis epidemic. During the roundtable, members of the Task Force highlighted the work being done to improve access to care, advocate for syphilis testing whenever indicated, innovate screening and testing methods of intervention, initiate syphilis treatment immediately, foster an environment of open communication, and further connect organizations to available HHS resources.
On February 29, CMS announced the release of the 2024 Impact Assessment Report. The report analyses the quality measures used in 26 CMS quality and value-based incentive payment programs. The report states that improvements in measure performance, largely prior to the COVID-19 public health emergency, are associated with positive impacts for millions of patients and substantial costs avoided. The report finds that during 2020 and 2021, 38% and 47% of measures analyzed, respectively, had scores worse than expected from baseline (2016–2019) trends, including significant worsening of key patient safety metrics. The full report can be found here.
On February 29, CMS released a statement noting that Medicare Administrative Contractors (MACs) updated March 2023 billing instructions for access to blood tests used to monitor for organ transplantation. The newly released instructions clarify that these tests remain available to patients when medically necessary and ordered by a physician.
On February 29, CMS announced that it is requesting comment on proposed refinements to the Quality Rating System (QRS) and qualified health plans (QHP) Enrollee Survey included in the Draft 2024 Call Letter for the Quality Rating System and the Qualified Health Plan Enrollee Experience Survey. In the Draft 2024 Call Letter, CMS is requesting feedback on topics including refinements to the QRS measure set, advancing health equity, Electronic Clinical Data System reporting, and QHP Enrollee Survey updates. Comments are due by March 28, 2024.
On February 29, CMS released the final part one guidance for the new Medicare Prescription Payment Plan program. The program was created by the Inflation Reduction Act (IRA) and requires Part D plans to provide enrollees the option to pay out-of-pocket (OOP) prescription drug costs in the form of monthly payments over the course of the plan year instead of all at once to the pharmacy.. The new guidance helps ensure that Part D plan sponsors can successfully implement the program and effectively build the necessary infrastructure for the program. The guidance requires Part D sponsors to notify a pharmacy to provide information on the program for anyone who meets a $600 OOP threshold based on a single prescription at the point-of-sale. Additionally, the guidance also finalizes the requirement that Part D sponsors must process election requests within 24 hours during the plan year. Through the guidance, CMS establishes a requirement for Part D sponsors to use a Bank Identification Number (BIN) and/or Processor Control Number (PCN) that is unique to the payment plan program to ensure program participants are charged $0 at the pharmacy. CMS also released an Information Collection Request (ICR) for the Medicare Prescription Payment Plan, which includes model materials for Part D plan sponsors to use when communicating to enrollees about the program. Comments on the ICD are due by April 29, 2024. A fact sheet detailing the final part one guidance can be found here.
On March 1, HHS, along with eight other agencies, released a final rule that restores religious liberty protections for beneficiaries of federally funded social services. The final rule will: (1) require federal grantees that administer social service programs to notify beneficiaries of their right to be free from discrimination on the basis of religion and providing a model notice for providers’ use; (2) make clear that all covered social service programs may not discriminate against beneficiaries on the basis of their religion; and (3) encourage governmental agencies that fund domestic programs to help beneficiaries identify alternative federally funded service providers in their area, including providers that are more compatible with their beliefs.
White House
On February 27, the Biden Administration announced 141 new commitments from stakeholders across the nation, including health systems, insurers, companies, non-profits, philanthropic groups, academia, and local elected officials, who responded to the White House Challenge to End Hunger and Build Healthy Communities. The challenge was a nationwide call-to-action to make commitments to advance President Biden’s goal to end hunger and reduce diet-related diseases by 2030, while reducing health disparities. The $1.7 billion in new commitments build on $8 billion in commitments announced at the White House Conference on Hunger, Nutrition, and Health.
On February 28, the White House announced that it will host a listening session on pharmacy benefit manager (PBM) reform on Monday, March 4, 2024. Invitees include Cost Plus Drug Company Founder Mark Cuban and Federal Trade Commission (FTC) Chair Lina Khan.
On February 28, President Biden issued an Executive Order (EO) mandating that the U.S. Department of Health and Human Services (HHS), along with other agencies, take steps to protect Americans’ data from being collected and sold to countries of concern. The data includes personal and sensitive information, including genomic data, biometric data, personal health data, geolocation data, financial data, and other types of personally identifiable information. A fact sheet on the EO can be found here.
On February 29, Assistant to the President and Director of the Gender Policy Council Jennifer Klein and Assistant and Senior Advisor to the President and Director of the Office of Public Engagement Stephen Benjamin convened a roundtable discussion on the importance of ensuring access to fertility services—including in vitro fertilization (IVF)—in the wake of the Alabama Supreme Court ruling that has halted access to IVF in much of the state. Participants included leaders of national advocacy organizations dedicated to improving access to fertility services, including fertility preservation, and health care provider associations.
President Biden will give his State of the Union Address to a Joint Session of Congress on March 7. He is expect to submit his FY2025 Budget proposal on March 11.
RULES AT THE WHITE HOUSE OFFICE OF MANAGEMENT & BUDGET (OMB)
Pending Review
CMS
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
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
Ensuring Access to Medicaid Services (CMS-2442); Final Rule; 1/26/24
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY 2025 Rates (CMS-1808); Proposed Rule; 1/31/24
HHS Notice of Benefit and Payment Parameters for 2025 (CMS-9895); Final Rule; 2/15/24
FY 2025 Hospice Wage Index, Payment Rate Update, and Quality Reporting Requirements (CMS-1810); Proposed Rule; 2/16/24
Short-Term, Limited-Duration Insurance; Independent, Noncoordinated Excepted Benefits Coverage; and Tax Treatment of Certain Accident and Health Insurance (CMS-9904); Final Rule; 2/22/24
Contract Year 2025 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, and Medicare Cost Plan Programs, and PACE (CMS-4205); Final Rule; 2/22/24
FY 2025 Inpatient Psychiatric Facilities Prospective Payment System Rate and Quality Reporting Updates (CMS-1806); Proposed Rule; 2/28/24
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
Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Notice; 2/28/24
ONC
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Proposed Rule; 1/18/24
REPORTS
Office of Inspector General (OIG)
On February 26, OIG released a report detailing lessons learned during the COVID-19 pandemic that could improve care in nursing homes. OIG found that nursing homes faced monumental and ongoing staffing challenges, including a significant loss of staff and substantial difficulties in hiring, training, and retaining new staff. OIG noted that many nursing homes used outside staffing agencies to fill gaps, which had significant downsides. Additionally, OIG found that nursing homes continued to struggle with costs, testing protocols, personal protective equipment compliance, and vaccination rates after initial challenges were resolved. OIG made five recommendations to CMS including that CMS: (1) implement and expand upon its policies and programs to strengthen the nursing home workforce; (2) reassess nurse aide training and certification requirements; (3) update the nursing home requirements for infection control to incorporate lessons learned from the pandemic; (4) provide effective guidance and assistance to nursing homes on how to comply with updated infection control requirements; and (5) facilitate sharing of strategies and information to help nursing homes overcome challenges and improve care.
UPCOMING HEARINGS
House
Oversight and Accountability
March 6; 10:00 AM; 2154 Rayburn
Examining the White House’s Role in Pandemic Preparedness and Response
Witness: Maj. Gen. Paul Friedrichs, M.D. (ret.), Director of the Office of Pandemic Preparedness and Response Policy, White House
Senate
Budget Committee
March 6; 10:00 AM; SD-608
How Primary Care Improves Health Care Efficiency
Witnesses: Christopher Koller, President Milbank Memorial Fund; Dr. Amol Navathe, Associate Professor, Perelman School of Medicine & the Wharton School, University of Pennsylvania; Dr. Bob Rauner, President, Partnership for a Healthy Nebraska & Representative, American Academy of Family Physicians; Lisa Grabert, Visiting Research Professor, Marquette University College of Nursing; and Dr. Christina Taylor, Chief Medical Officer, Value Based Care, Clover Health & President-elect, Iowa Medical Society.
Health, Education, Labor & Pensions Committee
March 7; 11:00 AM; SD-430
The Older Americans Act: Supporting Efforts to Meet the Needs of Seniors
OTHER POLICY NEWS
On March 1, a federal judge rejected AstraZeneca’s legal challenge seeking to overturn parts of the IRA’s Medicare drug price negotiation program. CMS selected AstraZeneca’s diabetes drug Farxiga as one of the first 10 drugs to be negotiated for 2026. U.S. District Judge Colm Connolly’s opinion makes clear that AstraZeneca’s constitutional challenge against the IRA should not move forward because the company “has no legitimate claim of entitlement to sell its drugs to the Government at any price other than what the Government is willing to pay.” HHS Secretary Xavier Becerra issued a statement applauding the decision noting, “today's ruling offers more reason for optimism that we will drive down the cost of prescription drugs in America.” AstraZeneca said it was disappointed in the ruling and evaluating its path forward.
The Medicare Payment Advisory Commission (MedPAC) will host its March meetings on March 7 and 8. Topics and session times can be found here and include:
Rural hospital and clinician payments;
Measuring utilization by Medicare Advantage (MA) enrollees;
MA quality;
The Acute Care Hospital at Home program; and
Updates on trends and issues in inpatient psychiatric hospital services.