The following is the latest health policy news from the federal government for June 21-28.  Some of the language used below is taken directly from government documents.

The Courts
  • The Supreme Court has overturned the court’s own decision in the 1984 case of Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc. that gave federal agencies considerable leeway to interpret ambiguous laws enacted by Congress.  While the Chevron decision called for the courts to defer to federal agency interpretation of ambiguous statutes if they found them to be reasonable, the latest Supreme Court decision calls for the courts to act independently when evaluating the appropriateness of agency interpretations and the regulations agencies implement in support of those interpretations.  This change is widely expected to affect how future federal health care legislation is implemented.  Learn more from the new Supreme Court decision.
  • In a challenge to the Affordable Care Act’s requirement that health insurers offer certain preventive care services with no copay, a federal appeals court ruled that requirement invalid because the U.S. Preventive Services Task Force, one of the parties involved in determining the preventive care services to which the requirement applies, is not subject to confirmation by Congress.  The court’s findings in Braidwood Management v. Becerra only affect the plaintiffs in the case – two businesses that together employ fewer than 100 people – and do not apply more broadly, although they may leave the requirement vulnerable to future challenges.  Learn more from the court’s decision in the case.
  • Contrary to past HHS guidance, a federal court has ruled that the agency does not have the authority to prevent hospitals from using third-party online tracking technology on their public web pages.  The data such technologies produce, the court found, does not violate HIPAA requirements because it does not yield patient-specific information.  Learn more from the court’s ruling.
Department of Health and Human Services
  • HHS has published a final rule that establishes penalties for health care providers that engage in “information blocking”:  practices that interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information by authorized users except as required by law or covered by a regulatory exception.  Under the new rule, hospitals and MIPS-eligible clinicians found to be engaging in information blocking will be considered out of compliance for interoperability requirements and receive less than the full Medicare update; critical access hospitals that engage in information blocking will receive from Medicare 100 percent of their costs and not the usual 101 percent; and ACO participants may become ineligible to participate in the program for as long as one year.  Learn more about the implications of being referred by HHS’s Office of the Inspector General for information blocking from this HHS news release and from this pre-publication version of the final information blocking rule.
  • HHS announced that some Medicare enrollees will pay less for 64 prescription drugs available through Medicare Part B.  The drugs will have a reduced Part B coinsurance rate from July 1 through September 30 of this year because the drug companies that produce them raised prices faster than the rate of inflation.  More than 750,000 people with Medicare use these drugs annually.  Learn more from this HHS news release and go here to learn more about the reduced coinsurance program and find a list of the affected prescription drugs.
  • HHS’s Office of Climate Change and Health Equity has published case studies highlighting how two non-profit safety-net health care providers are using the Inflation Reduction Act to reduce carbon emissions.  The case studies are intended to offer health care organizations a roadmap for how to use the Inflation Reduction Act to serve their core mission, reduce climate-related health effects, and advance health equity.  Learn more from this HHS news release, which includes links to the two case studies.
  • HHS and its Health Resources and Services Administration (HRSA) have announced a new policy to facilitate access to housing for people with HIV served by the Ryan White HIV/AIDS Program.  The new guidance enables use of Ryan White HIV/AIDS Program funds to cover housing security deposits for eligible clients.  Learn more from this HHS announcement.
  • HHS and HRSA have awarded $56 million to support modernized technology in HRSA-funded health centers.  HRSA also is adopting a modernized Uniform Data System for health centers that will create automated reporting platforms for quality and performance management, thereby streamlining back-end work.  Award recipients will use this supplemental funding for new equipment, to meet interoperability standards, and to provide data management training to staff.  Learn more about the funding and how it will be used from this HHS news release, which includes a link to a list of grant recipients.
  • HHS’s Administration for Strategic Preparedness and Response (ASPR), through the Biomedical Advanced Research and Development Authority (BARDA), has introduced a pandemic influenza preparedness and response strategy.  In the strategy, BARDA seeks to leverage existing infrastructures and capabilities to respond to the current highly pathogenic avian influenza H5N1 threat while continuing to establish new capabilities to improve rapid response to both the current H5N1 virus and other potential pandemic influenza viruses in the future.  Learn more from this HHS announcement and the ASPR/BARDA pandemic influenza preparedness and response strategy.
  • HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) has published an issue brief that uses Nursing Home Care Compare Data from May of 2024 to examine current staffing levels in U.S. nursing homes relative to specific minimum staffing requirements in Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting final rule CMS published in April.  Find the ASPE issue brief here.
  • HHS’s Office of the Inspector General (OIG) has published a review of HHS’s compliance with the Federal Information Security Modernization Act of 2014 for FY 2023.  Overall, the OIG concluded that HHS’s information security program was “Not Effective.”  Learn more from this OIG report.
  • HHS’s Health Sector Cybersecurity Coordination Center and its Office of Information Security have posted a threat profile about Qilin, a ransomware-as-a-service group targeting the health care industry and other sectors.  Qilin targets through phishing and spear phishing emails and upon infiltration makes ransom demands.  The threat profile offers technical details about Qilin, describes attack techniques, offers information about prevention and mitigation, and directs readers to additional resources.  Go here to find the Qilin threat profile.
  • HHS’s Health Sector Cybersecurity Coordination Center and its Office of Information Security have posted a health sector alert about a critical vulnerability that has been identified in MOVEit, a common file transfer platform used in the health sector.  This vulnerability exposes health care organizations to cyberattacks, especially ransomware and data breaches.  Progress, the company that owns and operates the MOVEit platform, has released patches to fix this vulnerability but exploit code is also available to the public and this vulnerability is being actively targeted by cyber threat actors.  Learn more from this health sector alert.
  • HHS and the FBI have released a joint cybersecurity advisory to disseminate known indicators of compromise and tactics, techniques, and procedures used in a social engineering campaign targeting health care, public health entities, and providers.  Threat actors are using phishing schemes to steal login credentials for initial access and the diversion of automated clearinghouse payments to U.S.-controlled bank accounts.  Health care organizations are considered attractive targets for these threat actors because of their size, technological dependence, access to personal health information, and the unique impact of patient care disruptions.  The FBI and HHS encourage organizations to implement specific recommendations to reduce the likelihood and impact of social engineering incidents.  Learn more from this advisory, which describes how the attacks are launched, gives examples of indicators of compromise, offers mitigation advice, and directs stakeholders to additional resources.
Centers for Medicare & Medicaid Services
  • CMS has issued its calendar year 2025 home health prospective payment system proposed rule, which calls for reducing the 2025 home health base payment rate by 4.067 percent to account for the impact of implementing the Patient-Driven Groupings Model (PDGM).  CMS also proposes recalibrating the PDGM case-mix weights; updating the fixed dollar loss for outlier payments; updating the low utilization payment adjustment thresholds, functional impairment levels, and comorbidity adjustment subgroups; establishing a home health occupational therapy low utilization payment adjustment add-on factor; updating other low utilization payment adjustment add-on factors; and more.  Learn more about how CMS proposes updating the home health prospective payment system for 2025 from this CMS fact sheet and this preview version of the proposed rule.  The proposed rule is scheduled for official publication on July 3 and the deadline for stakeholders to submit comments is August 26.
  • CMS has issued its calendar year 2025 end-stage renal disease (ESRD) prospective payment system proposed rule, which would raise the base rate from the current $271.02 to $273.20; update the acute kidney injury dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year 2025 and extend Medicare payment to dialysis in the home setting for beneficiaries with acute kidney injury; provides information on how CMS will operationalize the inclusion of oral-only drugs in the ESRD prospective payment system as of January 1, 2025; update requirements for the ESRD Quality Incentive Program; and more.  Learn more about the proposed ESRD prospective payment system rule for 2025 from this CMS news release and this pre-publication version of the proposed rule.  The deadline for submitting comments is August 26.
  • CMS has updated its recently published July bulletin on ambulatory surgical center payments.  The update removes five codes.  Go here to see the updated version of the July bulletin.
  • CMS has published technical FAQs for pharmacies about the Preexposure Prophylaxis (PrEP) Using Antiretroviral Drugs to Prevent HIV National Coverage Determination, which it expects to release in late September of this year.  Learn more from this fact sheet; the national coverage analysis; and the FAQs.
  • Eighteen states will receive CMS grants for the implementation, enhancement, and expansion of Medicaid and CHIP school-based services.  The states will use these funds to support their efforts to connect millions more children at school to health care services, especially mental health services.  The participating states will each receive up to $2.5 million over three years for the implementation, enhancement, and expansion of the use of school-based health services through Medicaid and CHIP.  Go here (and scroll down to “CMS Awards School-Based Services Grants to 18 States – June 25, 2024”) to learn more about the funding and the states that will receive it.
  • CMS is asking the Office of Management and Budget (OMB) for permission to continue requiring home health care providers to continue notifying original Medicare beneficiaries receiving home health care benefits of plans of care changes through formal Home Health Change of Care Notices.  CMS invites stakeholders to submit comments on the need for such notices and the administrative burden of providing them.  Learn more about the current requirement, CMS’s desire to extend it, and the estimated burden of compliance from this CMS notice.  The deadline for submitting comments is August 26.
  • CMS is asking OMB for permission to revise two current health care reporting requirements made of consumers.  The first is its proposed revision of a form that authorizes Medicare beneficiaries to appoint a representative to act on their behalf to respond to an initial claim determination or appeal; and the second is a proposed change in the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey that many Medicare beneficiaries complete to help the agency evaluate the effectiveness of the various means through which Medicare serves the Medicare population.  CMS invites stakeholders to submit comments on the need for such notices and the administrative burden of providing them.  Learn more about the current requirements, the changes CMS proposes, and the estimated burden of compliance from this CMS notice.  The deadline for submitting comments is July 25.
  • CMS is asking OMB for permission to continue its use of two current health care reporting requirements:  the Organ Procurement Organization/Histocompatibility Laboratory Cost Report Form (CMS-216-94) and the Hospice Facility Cost Report (CMS-1984-14).  Learn more about the purpose of these forms and the administrative burden CMS projects for completing them from this CMS notice.  The deadline for submitting stakeholder comments is August 26.
HHS Newsletters
  • CMS – MLN Connects – June 27
  • AHRQ News Now – June 25
  • HRSA eNews – June 20 (includes funding opportunities)
Centers for Disease Control and Prevention
  • The CDC has updated its recommendations for the use of respiratory syncytial virus (RSV) vaccines for people ages 60 and older.  Learn about the new recommendation from this CDC news release.
  • The CDC has issued recommendations for updated 2024-2025 COVID-19 vaccines and the updated 2024-2025 flu vaccines to protect against severe COVID-19 and flu this fall and winter.  Learn more about the latest vaccine recommendations from this CDC news release.
  • The CDC has issued a health alert to notify health care providers, public health authorities, and the public about an increased risk of dengue virus infections in the U.S. in 2024.  The global incidence of dengue in 2024 has been the highest on record this calendar year and many countries – including the U.S. –  are reporting higher-than-usual dengue case numbers.  For background information about the virus, including symptoms, testing, diagnosis, treatment, and other resources, see this CDC health alert.
Food and Drug Administration

The FDA has granted marketing authorization for the first hepatitis C test that can be used at certified point-of-care settings for individuals at risk for hepatitis C.  Learn more from this FDA news release.

National Institutes of Health

The NIH’s National Institute for Mental Health (NIMH) has issued a request for information on its strategic plan.  As the lead federal agency for research on mental illnesses, NIMH is guided by its strategic plan for research, which outlines the institute’s priorities, spanning fundamental science to public health impact.  Now, the agency is soliciting feedback on who is using its strategic plan, how they are using the strategic plan, what elements of the plan are useful and what are not, and what is missing from the plan.  Learn more about the NIMH and the feedback it seeks from this NIH notice.  The deadline for responding to the request for information is July 24.

Congressional Budget Office (CBO)

The CBO has prepared an analysis of the potential effects on the federal budget and on health insurance coverage of permanently extending the expanded premium tax credit and about the cost of that credit for Deferred Action for Childhood Arrivals recipients.  Find that CBO report here.

Stakeholder Events

CMS – Physicians, Nurses, and Allied Health Professionals Open Door Forum – July 11

CMS will hold an open-door forum for physicians, nurses, and allied health professionals on Thursday, July 11 at 2:00 (eastern).  Go here to register to participate.

HHS/Health Resources and Services Administration – National Telehealth Conference – July 16

HHS’s Health Resources and Services Administration (HRSA) will hold a virtual national telehealth conference on Tuesday, July 16 from 9:30-5:00 (eastern).  Conference topics will include licensing across state lines to increase access to behavioral health care; implications of health policy to inform telehealth’s future; expanding access to services for underserved and low-income communities; exploring health care innovations and future telehealth technologies; and improving health equity through expansion of broadband connectivity and adoption of telehealth.  Go here to learn more about the conference and to register to participate.

CMS – Rural Health Open Door Forum – July 18

CMS will hold an open-door forum for rural health care providers on Thursday, July 18 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.

CMS – Skilled Nursing Facility/Long-Term Care Open Door Forum – July 25

CMS will hold an open-door forum for skilled nursing facility and long-term care facility operators on Thursday, July 25 at 2:00 (eastern).  Go here to register to participate.

CMS – Long-Term Services and Supports Open Door Forum – July 30

CMS will hold an open-door forum for long-term services and supports providers on Tuesday, July 30 at 2:00 (eastern).  Go here to register to participate.

CMS – Post-Acute Care Health Equity Confidential Feedback Report Listening Session – July 31

CMS will hold a listening session on Wednesday July 31 at 2:00 (eastern) to discuss the 2023 Health Equity Confidential Feedback Reports, which were released to post-acute-care providers in home health, inpatient rehabilitation facility, long-term-care hospital, and skilled nursing facility settings.  The goal of the listening session is to gather feedback from providers and stakeholders on the post-acute care health equity confidential feedback to guide the development of this report in the future.  Go here to learn more about the listening session and to register to participate.

CMS – 2024 “Rural Health Hackathon” – August 14, 22, and 29

In August CMS and its Center for Medicare and Medicaid Innovation will hold a series of collaborative sessions, to be held in person, designed to generate and develop creative and actionable ideas to address rural health challenges.  The event seeks to build on CMS’s outreach to rural communities through site visits and listening sessions to better understand rural health care issues.  At these sessions CMS will bring together rural health community care providers, community organizations, industry and tech entrepreneurs, funders, policy experts, and beneficiaries to attempt to take advantage of the collective experience and expertise of participants to generate new ideas to address some of the top challenges affecting health care in rural health settings and drive action to improve clinical outcomes, increase access, and foster a better care experience for patients and providers in rural communities.  Hackathon events will be held in person on August 14 in Bozeman, Montana; on August 22 in Dallas; and on August 29 in Wilson, North Carolina.  Learn more about the event, including how to participate in person or submit ideas virtually, from this CMS announcement.

CMS – National Provider Compliance Conference – August 7-8

CMS will hold its National Provider Compliance Conference on Wednesday, August 7 and Thursday, August 8.  The conference will bring together Medicare Administrative Contractors (MACs) and program integrity experts to provide compliance professionals with the information and tools they need to efficiently and effectively submit Medicare Part A, Part B, home health, hospice, and durable medical equipment claims.  The target audience is anyone who processes Medicare Part A and Part B, home health, hospice, or DME claims, including physicians, non-physician practitioners, billing specialists, suppliers, associations, coders, and medical review contractors.  Go here to learn more about the conference and to register to participate in the virtual event.  The deadline for registering is July 31.