The following is the latest health policy news from the federal government for May 31-June 6.  Some of the language used below is taken directly from government documents.

Centers for Medicare & Medicaid Services
  • The deadline for stakeholders to submit comments on CMS’s proposed FY 2025 Medicare inpatient prospective payment system and long-term-care hospital prospective payment system regulation is Monday, June 10.  Go here for further information about the proposed rule and how to submit comments.
  • CMS has posted a bulletin describing billing changes in the Medicare hospital outpatient prospective payment system that will take effect on July 1.  Find that bulletin here.
  • CMS is accepting applications to participate in its ACO Primary Care Flex Model, which seeks to increase participation in ACOs and the Medicare Shared Savings Program and increase the number of people with Medicare in an accountable care relationship.  The ACO Primary Care Flex Model is a voluntary model that will focus on primary care delivery in the Shared Savings Program and will test how prospective payments and increased funding for primary care in ACOs affect health outcomes, quality, and costs of care.  The model will launch on January 1 and run for five years.  Learn more about the model, requirements for participation, and how to apply to participate from the ACO Primary Care Flex Model web page and the program’s request for applications.  Organizations interested in participating must first apply, either as new ACOs or renewing ACOs, to the Shared Savings Program.  The deadline for submitting applications to the Shared Savings Program is June 17 and applicant ACOs must submit a supplemental ACO Primary Care Flex Model application questionnaire by August 1.
  • CMS is inviting a second round of applications to participate in its Enhancing Oncology Model beginning next year.  It also has announced several refinements of the model’s policies, including increasing the monthly base payment, raising the threshold for the point at which participants are required to pay back CMS for costs related to their patients’ care, and extending the model by two years, until June of 2030.  Learn more about the program, how it works, and the changes CMS is making from this CMS announcement and the request for applications.  The application portal to apply will open in July and the deadline for submitting applications is September 16.
  • CMS and HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) have added 10 new states to the Certified Community Behavioral Health Clinic (CCBHC) Medicaid Demonstration Program.  The program seeks to increase access to crisis and behavioral health care in the community, providing reimbursement through Medicaid for the full cost of services that CCBHCs provide at higher, more competitive rates than community mental health centers previously received for Medicaid patients.  This sustainable funding seeks to enable CCBHCs to provide a comprehensive range of services rather than fragmented services driven by separate billing codes.  Learn more about the program and the new states that will be participating in it from this HHS news release.
  • CMS has posted a report presenting the scheduled state timelines for completing their Medicaid unwinding-related renewal activities.  The report includes projected end dates for each state’s unwinding efforts.  Find the report here.
  • At the same time CMS has published this report it has sent a letter to state Medicaid officials to inform them that it is extending current state reporting of certain metrics contained in the unwinding data report.  CMS is extending reporting of these metrics to support continued insight into state eligibility and enrollment operations and to further strengthen CMS’s ability to identify and address areas of non-compliance with federal renewal and fair hearing requirements.  Monthly state reporting about renewal actions occurring on or after July 1, 2024 and fair hearing requests that have been pending for more than 90 days as of the end of the reporting period will continue on an ongoing basis.  CMS also intends to continue reporting data publicly to maintain transparency into Medicaid and CHIP renewal outcomes at the national and state level.  Learn more from CMS’s letter to state Medicaid officials.
  • CMS has updated the FAQ for its Home Health Value-Based Purchasing Model.  Find the updated FAQ here.
  • Writing in the publication Health Affairs, CMS has published an update on its efforts to pursue health equity through the use of value-based care.  Find the article here.
  • CMS has posted an FAQ on Medicaid and CHIP coverage of peer support services as a component of a comprehensive mental health and substance use service delivery system.  Find the FAQ here.
  • Under federal law, Medicare Advantage programs and Part D sponsors must employ approved processes for outreach to individuals identified as likely to benefit from, enroll in, or terminate their participation in such programs.  CMS has developed model notices to provide standardized and consistent language for potential and active program participants, regardless of which Part D plan they may be enrolled in, and it will require Part D plans to disseminate these notices, as appropriate, to Part D enrollees.  Now, the agency invites comment on those notices.  Go here to learn more about this undertaking and here to find the model notices.     The deadline for submitting comments is June 27.
  • CMS invites public comment on data collection requirements it imposes on hospitals involving examination and treatment for emergency medical conditions and women in labor under EMTALA and certain rate increase disclosure and review requirements.  Learn more about the data CMS collects and the input it seeks from this CMS notice.  The deadline for submitting comments is August 5.
Department of Health and Human Services
  • HHS’s Office for Civil Rights updated its FAQ about the Change Healthcare cybersecurity incident, which focuses on aspects of the incident that involve potential breaches of HIPAA rules and requirements.  Among the major aspects of the update is the following guidance:
    • Covered entities affected by the Change Healthcare breach may delegate to Change Healthcare the task of providing the required HIPAA breach notifications on their behalf.
    • Only one entity – which could be the covered entity itself or Change Healthcare – needs to complete breach notifications to affected individuals, HHS, and, where applicable, the media.
    • If covered entities work with Change Healthcare to perform the required breach notifications in a manner consistent with the HITECH Act and HIPAA Breach Notification Rule, they will not have additional HIPAA breach notification obligations.

Learn more from this HHS news release and the updated FAQ.

  • HHS invites public comment on its intention to seek information, primarily from institutions and institutional review boards, to determine whether those engaged in non-exempt research involving human subjects conducted or supported by a Common Rule department or agency have established adequate administrative policies and procedures for protecting the rights and welfare of human subjects in research and accepts that responsibility.  Other reporting requirements will be used to assess whether the institution is following the established procedures; ensure that federal funds are not expended for unapproved human subjects research; and determine if the approved status of an awarded grant, contract, or cooperative agreement should be reviewed, with the ultimate goal of maintaining or increasing human subject protections.  Learn more from this HHS notice.  The deadline for submitting comments is August 2.
  • HHS seeks comments on its intention to collect information from ambulatory surgical centers to determine whether such facilities properly train staff to provide the appropriate type and level of care for the environment of ambulatory surgical center patients.  Learn more about the data HHS collects and why it collects it from this agency notice.  The deadline for submitting comments is July 1.
  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) invites the general public and stakeholders to comment on the continuation of current data collection activities associated with SAMHSA-certified opioid treatment programs.  SAMHSA seeks continued approval of the information-collection requirements in the regulation governing such programs and of the forms used in implementing the regulation.  Learn more from this SAMHSA notice.  The deadline for submitting comments is August 5.
  • HHS’s Office of the Assistant Secretary for Health (OASH) is seeking OMB approval of a new information collection activity, the OASH Periodic Performance Project Report for Grants and Cooperative Agreements.  The purpose of this data collection is to gather quantitative and qualitative information common to the assessment of recipient performance on individual grants and cooperative agreements managed by OASH.  OASH will collect common data elements measuring the performance of each recipient against the approved grant project plan, including progress toward goals and outcomes.  Learn more from this HHS notice.  The deadline for submitting comments is July 5.
  • HHS’s Health Resources and Services Administration (HRSA) announced a combined investment of $15 million over four years through the Rural Maternity and Obstetrics Management Strategies Program to improve maternal health in rural communities and a new program focused on strengthening maternal care and reducing disparities in the Delta region (within Alabama, Arkansas, Illinois, Kentucky, Louisiana, Mississippi, Missouri, and Tennessee).  Learn more about the program and its latest participants from this HHS news release and the Rural Maternity and Obstetrics Management Strategies Program web page.
  • HHS’s Health Sector Cybersecurity Coordination Center and its Office of Information Security have issued a report on distributed-denial-of-service (DDoS) attacks, a type of cyberattack in which an attacker uses multiple systems, often referred to as a botnet, to send a high volume of traffic or requests to a targeted network or system, overwhelming it and making it unavailable to legitimate users.  The report defines and describes the attacks and the attackers, offers tips for prevention and response, and directs interested parties to additional resources.  Find the report here.
  • HHS’s Health Sector Cybersecurity Coordination Center and its Office of Information Security have posted a bulletin describing vulnerabilities in various Baxter products, including the Baxter Welch Allyn Configuration Tool and the Baxter Welch Allyn Connex Spot Monitor.  The bulletin describes the challenge, the vulnerabilities, defensive measures, and mitigation and directs affected parties to additional resources.  Find the bulletin here.
  • HHS has posted a fact sheet describing its response, and that of the FDA, CDC, and Department of Agriculture, to recent cases of avian (bird) flu in dairy cattle and two farm workers.  The fact sheet addresses treatment, personal protective equipment assistance, genomic analysis, safety guidance, educating workers, health surveillance, and exposure monitoring.  Learn more from this HHS fact sheet; an FDA update on its avian flu efforts; updated information from the CDC; and this Department of Agriculture avian flu web page.
  • HHS’s Office of the Inspector General has submitted its semi-annual report to Congress; the report covers the period from October of 2023 through March of this year.  Among other issues, the report highlights more than $2.76 billion that the federal government expects to recover as a result of audits and investigations during reporting period.  Find the report here.
HHS Newsletters
  • CMS – MLN Connects – June 6
  • AHRQ News Now – June 4
  • HRSA eNews – May 17 (includes funding opportunities)
Centers for Disease Control and Prevention

The CDC has published a notice inviting comment on a proposed information collection project titled National Healthcare Safety Network (NHSN) Coronavirus (COVID-19) Surveillance in Healthcare Facilities.  This data collection is designed to standardize the data elements collected from across the country regarding the impact of COVID-19 on health care facilities.  Learn more from this CDC notice.  The deadline for submitting comments is August 5.

National Institutes of Health
  • The NIH has posted a brief summary of two current clinical trials examining a novel long-acting form of HIV pre-exposure prophylaxis in cisgender women and people who inject drugs.  The mid-stage studies will assess the safety, acceptability, and pharmacokinetics of an antiretroviral drug administered by injection every six months.  Find the notice here.
  • The NIH has published its plan for advancing H5N1 (bird or avian) influenza basic research and translating those findings into strategies and interventions that can benefit people.  The research agenda focuses on four key objectives:  increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus.  Learn more from this NIH news release.
Medicare Payment Advisory Commission (MedPAC)

MedPAC has written to CMS in response to the proposed FY 2025 Medicare inpatient prospective payment system regulation.  In its letter MedPAC addressed the proposed increase in inpatient prospective payment system and capital base rates; the proposed Transforming Episode Accountability Model (TEAM); the addition of a new payment to small, independent hospitals for maintaining a buffer stock of essential medicines; updated wage index values and policies; and updated outlier reconciliation thresholds.  Go here to find MedPAC’s letter to CMS.

Congressional Budget Office (CBO)

The CBO has published a preliminary report on the effects of extreme temperatures from climate change on the Medicare population, including the effect on health status and mortality, access to care, and Medicare costs.  Find the report here.

Stakeholder Events

CMS – Skilled Nursing Facility/Long-Term Care Open Door Forum – June 13

CMS will hold an open-door forum for skilled nursing and long-term care operators on Thursday, June 13 at 2:00 (eastern).  Go here to register to participate.

CMS – Annual Public Meeting About New and Reconsidered Clinical Diagnostic Laboratory Test Codes for 2025 – June 25

CMS will hold a public meeting on Tuesday, June 25 at 9:00 (eastern) to receive comments and recommendations on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule for calendar year 2025.  This meeting also will provide a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.  Go here to learn more about the meeting, including how to submit information and questions and register to participate.

CMS – Home Health, Hospice, and DME Open Door Forum – June 26

CMS will hold an open-door forum for home health, hospice, and durable medical equipment operators on Wednesday, June 26 at 2:00 (eastern).  Go here to register to participate.

CMS – Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests – July 25-26

CMS’s Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests will hold public meetings on Thursday, July 25 and Friday, July 26.  The panel advises the Secretary of the Department of Health and Human Services and the CMS Administrator on issues involving clinical diagnostic laboratory tests.  Learn more about the meetings and how to participate from this CMS notice.