This Week’s Highlight

CMS National Stakeholder Call – January 23

On Tuesday, January 23, the Centers for Medicare and Medicaid Services (CMS) hosted a National Stakeholder Call. The call lasted approximately 45 minutes and featured updates from the heads of each of the CMS departments listed below. The call opened with an update from Administrator Chaquita Brooks-LaSure, who focused on the administration’s achievements and noted that 2023 was the third straight year of record-breaking enrollments in health plans offered in the marketplace. She also discussed implementation of the Inflation Reduction Act, which is expected to cut healthcare costs for many seniors.

The Administrator, Deputy Administrator, Dr. Meena Seshamani, and many of the subsequent presenters, also highlighted the agency’s efforts to expand access to mental and behavioral health services, as well as to promote health equity. Many presenters highlighted the agency’s decision to allow marriage and family therapists and mental health counselors to enroll as Medicare providers, allowing more than 400,000 additional providers to offer mental health services to Medicare beneficiaries. Dr. Aditi Mallick, Acting Director of the Office of Minority Health touted the first ever CMS-hosted Health Equity Conference in 2023 and invited those interested to submit abstract for the 2024 Conference by February 9. Of note, Dr. Dora Hughes, Acting CMS Chief Medical Officer and Director, Center for Clinical Standards and Quality, said CMS expects to finalize guidance documents implementing the transitional coverage for emerging technologies (TCET) pathway later this year.

Other Agency News

Centers for Medicare and Medicaid Services

MedPAC and MACPAC jointly publish DataBook on Beneficiaries Dually Eligible for Medicare and Medicaid

• There were 12.8 million people who were dually eligible for Medicare and Medicaid for at least one month in 2021.
• People who are dually eligible for Medicare and Medicaid account for a disproportionate share of spending in both programs.
  • Dual-eligible beneficiaries totaled 19 percent of the Medicare population in 2021 but accounted for 35 percent of Medicare spending.
  • Similarly, dual-eligible beneficiaries accounted for 13 percent of all Medicaid beneficiaries but 27 percent of Medicaid spending.
• Reflecting the continued shift from fee-for-service (FFS) to managed care in Medicare and Medicaid:
  • Less than half of dual-eligible beneficiaries (42 percent) were enrolled only in Medicare FFS in 2021, 46 percent were in managed care only, and 13 percent spent part of the year in FFS and part of the year in managed care.
  • For Medicaid services, 42 percent of dual-eligible beneficiaries had at least one month of comprehensive managed care enrollment.
• One-quarter (25 percent) of all dual-eligible beneficiaries had at least one month in which they were simultaneously enrolled in a Medicare managed care plan and a comprehensive Medicaid managed care plan. Another 48 percent of all dual-eligible beneficiaries had some enrollment in Medicare managed care and/or comprehensive Medicaid managed care but not simultaneously.

CMS Requests Information on MA Data Release as Congress Calls for More Data

CMS requests information on how to meet shared goals of enhancing data capatilbties to have better insight into MA programs. Strategies include making MA data-sharing commensurate with traditional Medicare data sharing, and allowing for analysis in the context of other programs like ACOs, the Marketplace, integrated delivery systems and Medicaid managed care. More

At the same time, the Medicare Advantage Supplemental Benefits Transparency Act of 2023, introduced by Sens. Mark Warner (D-VA) and Marsha Blackburn (R-TN) would require MA plans to report enrolle-level data on supplemental benefits, beneficiary eligibility, benefit categories, and benefit utilization and payments.

CMS Updates Open Payments (Physician Payments Sunshine Act) Data

Open Payments data have been updated to reflect changes that took place since the last publication in June 2023. The refreshed Open Payments data includes:

• Record Updates: Changes to non-disputed records made on or before November 15, 2023, are published.
• Disputed Records: Dispute resolutions completed on or before December 31, 2023, are displayed with the updated information. Records with active disputes that were not resolved by December 31, 2023, are displayed as disputed.
• Record Deletions: Records deleted before December 31, 2023, were removed from the Open Payments database. Records deleted after December 31, 2023, remained in the database, but will be removed during the next data publication in June 2024.
• The following is not included in the data refresh:
  • Any records submitted to the Open Payments system for the first time after the close of the Program Year 2022 submission window (March 31, 2023).
  • Any records disputed and for which dispute resolution resulted in a change to the covered recipient.

CMMI Touts Start of BPCI-A Model Year 7

Since the start of Model Year 6, and continuing through Model Years 7 and 8, the model has 8 Clinical Episode Service Line Groups with 29 Inpatient, 3 Outpatient, and 2 multi-setting Clinical Episode Categories. BPCI-A aims to support healthcare providers who invest in practice innovation and care redesign to better coordinate care and reduce expenditures, while improving the quality of care for Medicare beneficiaries. BPCI Advanced qualifies as an Advanced Alternative Payment Model (APM) under the Quality Payment Program.

Ranking of Selected Clinical Episode Service Line Groups

1. Cardiac Care (Acute Myocardial Infarction (AMI), Cardiac Arrhythmia, Congestive Heart Failure)
2. Medical & Critical Care (Cellulitis; Chronic Obstructive Pulmonary Disease (COPD), Bronchitis, Asthma; Renal Failure; Sepsis; Simple Pneumonia and Respiratory Infections; Urinary Tract Infection)
3. Orthopedics (Double Joint Replacement of the Lower Extremity, Fractures of the Femur and Hip or Pelvis, Hip and Femur Procedures Except Major Joint, Lower Extremity/Humerus Procedure Except Hip, Foot, Femur, Major Joint Replacement of the Lower Extremity (MJRLE) (Multi-setting Inpatient/Outpatient), Major Joint Replacement of the Upper Extremity (MJRUE) (Multi-setting Inpatient/Outpatient))
4. Gastrointestinal Care (Disorders of the Liver Except Malignancy, Cirrhosis, or Alcoholic Hepatitis; Gastrointestinal Hemorrhage; Gastrointestinal Obstruction; Inflammatory Bowel Disease)
5. Neurological Care (Seizures, Stroke)
6. Gastrointestinal Surgery (Bariatric surgery, Major bowel procedure)
7. Spinal Procedures (Back and Neck Except Spinal Fusion (Inpatient), Back and Neck Except Spinal Fusion (Outpatient), Spinal Fusion)
8. Cardiac Procedures (Cardiac Defibrillator (Inpatient), Cardiac Defibrillator (Outpatient), Cardiac Valve, Coronary Artery Bypass Graft (CABG), Endovascular Cardiac Valve Replacement, Pacemaker, Percutaneous Coronary Intervention (PCI – Inpatient), Percutaneous Coronary Intervention (PCI – Outpatient)).

CMS Outlines Correct Use of Outpatient E/M Add-on Code

CMS has provided additional information, including clinical vignettes, for clinicians looking to bill the controversial new code.

Food and Drug Administration

Medical Device Sterilization Town Hall

On January 26, 2024, the FDA hosted the second in a series of medical device sterilization town halls to:

• Describe the FDA’s early actions to help assure sterilization capacity in the U.S. and recent activities to reduce overall EtO reliance while maintaining a resilient supply of sterilized medical devices
• Discuss the FDA’s understanding of opportunities and challenges to using alternative sterilization methods
• Describe creation of a dedicated EtO Tiger Team to advance innovations in medical device sterilization.

Next webinar scheduled for Wednesday, February 7.

FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting February 13

The panel will meet regarding the premarket approval application(PMA) for Abbott’s tricuspid valve edge-to-edge repair device. If approved,this device would be used to help treat people living with symptomatic severe tricuspid regurgitation who meet certain medical qualifications. More

Register for FDA Office of Minority Health and Health Equity (OMHHE) Technical Session for the Health Equity Innovation Award

As part of OMHHE’s Enhance EQUITY Initiative, OMHHE announced a new Health Equity Innovation Award: Enhance Equity Funding Opportunity. The purpose of this funding opportunity announcement (FOA) is to support innovative research that will strengthen and advance health outcomes for diverse communities. The FDA OMHHE will host a technical session on Thursday, February 1, 2024, from 1 PM – 2 PM EST for the Health Equity Innovation Award Funding Opportunity.

FDA Elevates Office of Strategic Partnerships and Technology Innovation to Super Office in CDRH

The following statement is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation (OST), CDRH:

CDRH is pleased to announce that, effective immediately, the Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a Super Office within the Center. The Super Office designation allows the Center, specifically OST, to be well-positioned and capable of adapting to and addressing future public health needs and challenges while continuing to advance the voice of patients, innovation and safety, regulatory science, and service excellence with our customers.

By elevating OST to a Super Office, several organizational shifts will occur, including the establishment of the following five offices within OST: Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR), and Office of Equity and Innovative Development (OEID).

Other News from Around HHS and Beyond

National Academies: Exploring Diversity, Equity, Inclusion, and Health Equity Commitments and Approaches by Health Organization C-Suites

Between 2020-2023, many health systems and organizations created formal positions to improve diversity, equity, and inclusion (DEI) and health equity in response to social and health injustices and public demands for diversity and equity among executive level leadership. The National Academies Roundtable on the Promotion of Health Equity hosted an October 2023 public hybrid workshop to explore the successes and challenges of DEI and health equity C-suites, dimensions of DEI and health equity commitments, strategies for achieving internal and external goals, and potential metrics for measuring success.

National Academies: Unequal Treatment Revisited: The Current State of Racial and Ethnic Disparities in Health Care: Proceedings of a Workshop

A National Academies committee hosted a public workshop series in 2023. Speakers invited by the committee discussed the current state of racial and ethnic health care disparities in the U.S., highlighted major drivers of health care disparities, provided insight into successful and unsuccessful interventions, identified gaps in the evidence base and proposed strategies to close those gaps, and considered ways to scale and spread effective interventions to reduce racial and ethnic inequities in health care. This workshop series is part of an ongoing consensus study examining the current state of racial and ethnic health care disparities in the U.S., building on the 2003 Institute of Medicine consensus report,

US Sells Off Helium Stockpile, Worrying MedTec

On Thursday, the U.S. government sold the Federal Helium Reserve, a massive underground stockpile based in Amarillo, Texas, that supplies up to 30% of the country’s helium. More

From the Hill

House Budget Committee Looks to Develop Fiscal Commission

The Commission would consist of 16 people to be selected by the House speaker and minority leader as well as the Senate majority and minority leaders. The commission would vote on its recommendations on the country’s fiscal issues, including the Medicare Part A trust fund, no later than Nov. 15 and then forward their ideas to the House and Senate, which will be required to vote on them. More

Bipartisan Group of Senators Request HHS’ Help with Permanent Telehealth Reform

In a January 19 letter, a group of 10 Senators asked Sec. Becerra to work with them to ensure Medicare beneficiaries have access to telehealth services when temporary waivers expire at the end of the year.

Other Notable News…

Cigna Projects Top Healthcare Trends for Employers in 2024 Top health care trends of 2024 and how they will impact U.S. employers

• Delivery and Navigation
• Population Health and Health Equity
• Patient Access, Experience, and Outcomes
• Plan Benefits and Design
• AI
• Curbing Increasing Pharmacy Costs

More