The following is the latest health policy news from the federal government for August 23-30.  Some of the language used below is taken directly from government documents.

340B

Johnson & Johnson, the pharmaceutical, biotechnology, and medical technologies company, told health care providers this week that it would shift from the long-time 340B upfront discount approach to a rebate model for two of its drugs and that eligible 340B hospitals and other providers will need to purchase the prescription drugs Stelara and Xarelto at list price and then, after dispensing them to patients, will need to submit 340B rebate claims to the company.  In response, HHS’s Health Resources and Services Administration (HRSA) wrote that “As the Health Resources and Services Administration has communicated to Johnson & Johnson, [its] proposal to implement a 340B rebate model is inconsistent with the 340B statute, which requires secretarial approval of any such proposal.”  The HRSA statement also noted that “The secretary has not approved J&J’s rebate model” and that “HRSA has communicated this information to J&J and will take appropriate actions as warranted.”  Learn more about Johnson & Johnson’s intentions from this notice it sent to 340B participants.

Centers for Medicare & Medicaid Services

  • The deadline for hospitals to submit a hardship exception application to delay submitting documentation that they were meaningful users of certified electronic health record technology (CEHRT) under the Medicare Promoting Interoperability Program for calendar year 2023 is August 31 (and November 30 for critical access hospitals).  Hospitals that do not meet the requirement are subject to a reduction of their Medicare payments.  Learn more about what constitutes grounds for a hardship exception and how to submit a hardship exception application from this CMS notice.
  • CMS has written to state Medicaid directors to describe its current approach to determining budget neutrality for Medicaid demonstration projects authorized under section 1115(a) of the Social Security Act.  The purpose of the memo is to give states and interested parties information about how CMS calculates and applies budget neutrality in demonstration approvals.  The methodology described in the letter reflects a change in CMS’s methodology since it last described this process in 2018 and is intended to update and supersede the agency’s 2018 description.  Go here to see the CMS letter to state Medicaid directors.
  • CMS has sent an informational bulletin to state Medicaid and CHIP programs presenting additional guidance to states on their obligation to come into compliance with federal regulations on timely processing of Medicaid and CHIP eligibility renewals and to update the timeline in which states must complete unwinding-related renewals.  CMS is giving states additional time to complete eligibility renewals, address backlogs in processing redeterminations, and ensure that states comply with federal renewal timeliness requirements by December of 2025. This bulletin outlines the duration and conditions under which states may rely on an exception to those requirements.  Find the CMS memo here.
  • CMS has published a summary of every HCPCS Level II code application and its coding decision for each application processed in a 2024 non-drug and non-biological items and services bulletin.  Each summary includes the Medicare Electronic Application Request Information System (MEARIS) identification number; the topic; a summary of the applicant’s request; CMS’s preliminary HCPCS Level II coding recommendation; a summary of public feedback from or following the HCPCS Level II public meeting; CMS’s final HCPCS Level II coding decision; and CMS’s preliminary and final benefit category and payment determination, if applicable.  Except as indicated, all new coding actions will take effect on October 1, 2024.  Find the publication here.
  • CMS has published a bulletin describing updates of the inpatient psychiatric facilities prospective payment system for FY 2025.  Find the bulletin here.
  • CMS has published a bulletin describing revisions of Medicare Part B’s coverage policy for pneumonia vaccines to update coverage requirements and bring Medicare policy into line with Advisory Committee on Immunization Practices recommendations for pneumonia vaccination coverage.  Find the bulletin here.
  • CMS has published a bulletin about the social determinants of health risk assessment that is part of annual Medicare wellness visits to clarify that the MACs will process G0136 using the physician fee schedule.  Find the bulletin here.
  • CMS has awarded contracts worth $100 million to “Navigators” – organizations that help underserved communities, consumers, and small businesses find and enroll in health coverage through HealthCare.gov.  Learn more about the funding for Navigators from this HHS news release and find a list of the new Navigator contracts here.

Department of Health and Human Services

  • HHS and its Health Resources and Services Administration (HRSA) have awarded more than $440 million in grants to expand voluntary, evidence-based maternal, infant, and early childhood home visiting services for eligible families.  In addition, the CDC will spend $118.5 million over five years to continue building the public health infrastructure to better identify and prevent pregnancy-related deaths.  Learn more about how this money will be used and find a link to a list of the HRSA grants from this HHS news release.
  • HRSA announced that the Organ Procurement and Transplantation Network (OPTN) board of directors, which has been the governing board that develops national organ allocation policy for 40 years, is now separately incorporated and independent from the board of United Network for Organ Sharing (UNOS), which for 40 years has been the federal government OPTN contractor.  HRSA has awarded an OPTN board support contract to American Institutes for Research to work with the newly incorporated OPTN board.  Learn more about this development and why it is being undertaken from this HHS news release.
  • HHS and its Substance Abuse and Mental Health Services Administration (SAMHSA) have announced more than $65 million in grants and notices of funding opportunities to address mental health and substance use crises.  This includes $27.5 million through the Strategic Prevention Framework – Partnerships for Success program to help Tribes, state and local governments, and colleges and universities to develop and deliver substance use prevention services and additional awards to support children with unmet behavioral health needs, increase access to behavioral health care for people who are or are at risk of becoming unhoused, and enhance the behavioral health workforce by supporting substance use disorder training for graduate-level health care professionals.  Learn more about the funding, the individual programs it will support, and the notices of funding opportunities from this HHS news release.
  • SAMHSA awarded an additional $81.3 million in grants to support the integration of primary and behavioral health care and to expand the capacity of drug treatment courts.  The grants fund eight specific initiatives.  Learn more about those initiatives and how the money will be used and find links to lists of grant recipients in this HHS news release.
  • HHS’s Office of the Inspector General has issued a favorable opinion about a proposed patient assistance program operated by a non-profit grant-making organization.  The program in question involves proposed subsidies for certain cost-sharing obligations for low-income Medicare enrollees who have diabetes and reside in a specified rural area and whether such a program would violate federal anti-kickback statutes and other guidelines and regulations.  Find the opinion here.
  • Beginning in late September, people can order four free COVID-19 tests per household from the federal government.  Learn more from this HHS notice.

HHS Newsletters

HHS Videos

CMS – “How to Participate as a Group in MIPS” – this video provides an overview about group participation in Medicare’s Merit-Based Incentive Payment System, or MIPS.  This video will enable users to understand how to participate in MIPS as a group and explain which clinicians in a practice will receive MIPS payment adjustments when their practice reports as a group.

Medicare Payment Advisory Commission (MedPAC)

MedPAC has submitted written comments to CMS in response to CMS’s proposed updates of its end-stage renal disease prospective payment system and its home health prospective payment system for FY 2025.  Find its letter in response to proposed renal disease services payment changes here and its letter about proposed FY 2025 home health payments here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

A new MACPAC issue brief provides a comparative review of methodological approaches for analyzing Medicaid long-term services and supports (LTSS) data, focusing specifically on four key analytic frameworks:  a CMS LTSS expenditure and user report; home- and community-based (HCBS) taxonomy work sponsored by HHS’s Assistant Secretary for Planning and Evaluation (ASPE); a DQ Atlas HCBS methodology brief; and HCBS analyses performed by the Kaiser Family Foundation.  The issue brief highlights differences in how these methodologies identify and categorize HCBS and institutional care claims.  Learn more from the MACPAC issue brief “Methodological Approaches for Analyzing Use and Spending in Medicaid Long-Term Services and Supports:  A Comparative Review.”

Food and Drug Administration

  • The FDA has approved two new tests that detect both COVID-19 and flu.  Learn more this FDA news release.
  • The FDA has approved new COVID-19 booster vaccines.  The new vaccines offer protection against more recent COVID-19 variations.  Learn more from this FDA news release.

Stakeholder Events

MedPAC – Commissioners Meeting – September 5-6

MedPAC commissioners will hold their next public meeting on Thursday, September 5 and Friday, September 6.  The meeting agenda and information about participating in the meetings in person or remotely are not yet available but when they are they will be posted here.

CMS – Hospital Open Door Forum – September 10

CMS will hold an open-door forum for hospital officials on Tuesday, September 10 at 2:00 (eastern).  Go here to register to participate.

CMS – 2024 ICD-10 Coordination and Maintenance Committee Meeting Update – September 10-11

CMS’s ICD-10 Coordination and Maintenance Committee Meeting will meet virtually on Tuesday, September 10 and Wednesday, September 11.  The final agenda and meeting materials for the procedure code topics to be discussed on September 10 are posted here on the CMS website and the final agenda and meeting materials for the diagnosis code topics to be discussed during both meetings will be posted here.  Registration is required to attend; go here to register.

HRSA – Council on Graduate Medical Education Meeting – September 12

HHS’s Health Resources and Services Administration will convene a virtual meeting of its Council on Graduate Medical Education on Thursday, September 12 at 10:00 (eastern).  Go here for information on the meeting agenda and materials and how to participate.

CMS – Maternal Health Webinar – September 17

CMS will hold a maternal health informational webinar offering an overview of maternal health affinity groups and the expression-of-interest process on Tuesday, September 17 at 2:00 (eastern).  Go here to register to participate.

CMS – Home Health, Hospice, and DME Open Door Forum – September 17

CMS will hold an open-door forum for home health, hospice, and DME providers on Wednesday, September 17 at 2:00 (eastern).  Go here to register to participate.

CDC – Outreach Webinar on Lyme Disease – September 19

As part of its clinician outreach and communication efforts, the CDC will hold a webinar on new clinical tools and resources to support patients with prolonged symptoms and   concerns about Lyme disease.  Presenters will offer a brief overview of Lyme disease, provide a diagnostic and management framework for patients with prolonged symptoms and concerns about Lyme disease, and review new clinical tools and resources to help support these patients.  Continuing education credits are available.  Learn more about the webinar and how to participate from this CDC notice.

MACPAC – Commissioners Meeting – September 19-20

MACPAC commissioners will hold their next public meeting on Thursday, September 19 and Friday, September 20.  The meeting agenda and information about participating in the meetings in person or remotely are not yet available but when they are they will be posted here.

CMS – Hospital Price Transparency Webinar – October 21

CMS will hold a webinar on hospital price transparency during which it will address encoding new January 2025 price transparency requirements data in machine-readable files on Monday, October 21 at 1:00 (eastern).  Go here to register to participate.