The following is the latest health policy news from the federal government for the week of September 26 to October 6.  Some of the language used below is taken directly from government documents.


  • HHS must immediately end its significant cut in reimbursement for 340B-covered prescription drugs provided on an outpatient basis to eligible patients, a federal court has ruled, writing that “The prospective portion of the 2022 reimbursement rate shall be vacated because it is defective and because vacating this portion of the 2022 OPPS Rule will not cause substantial disruption” and that “HHS should not be allowed to continue its unlawful 340B reimbursements for the remainder of the year just because it promises to fix the problem later.”  Learn more from this federal district court decision.
  • In response to this ruling, HHS shared its plan for responding to the court order by restoring a payment rate of average sales price plus six percent for 340B-covered drugs.  In a brief to the court it explained that “…the process of adjusting the 2022 OPPS payment rates for 340B hospitals would take approximately two weeks” because it “requires revisions to four different electronic data files and then testing by multiple offices to confirm that the revised files function appropriately before the files are loaded to the production environment where they will be used to calculate OPPS reimbursements on a prospective basis.”

Centers for Medicare & Medicaid Services

  • CMS has released a Request for Information (RFI) seeking public input on the idea of CMS creating a directory with information on health care providers and services or a “National Directory of Healthcare Providers and Services.”  In its announcement of the RFI, CMS notes that “Health care directories can serve as an important resource for patients, helping them locate providers who meet their individual needs and preferences and allowing them to compare health plan networks.”  The RFI suggests that such a directory could reduce directory maintenance burden on providers and outlines how modern interoperable technology could facilitate keeping such a directory updated.  Learn more from this CMS news release and this pre-publication version of a Federal Register notice.  Comments are due by December 6.
  • CMS has published Transmittal 17, which revises the Medicare cost report to reflect, among other things, a policy to phase in Medicare disproportionate share (Medicare DSH) DSH payment reductions for hospitals that transitioned from urban to rural when CMS finalized adoption of new OMB labor market standards in FY 2021; the temporary suspension of the two percent Medicare sequestration amount; and the need to report COVID-19 vaccines and monoclonal antibody products provided to patients.  Learn more from this update of the Medicare provider reimbursement manual and Medicare cost report Form CMS-2552-10 with the changes highlighted.
  • CMS has posted the annual adjustment in the amount in controversy threshold amounts for administrative law judge hearings and judicial review under the Medicare appeals process.  The adjustment to the threshold amounts for requests for hearings and judicial review filed on or after January 1, 2023 are $180 for administrative law judge hearings and $1,850 for judicial review.  Learn more from this Federal Register notice.
  • CMS has posted information about changes to beneficiary coinsurance for additional procedures furnished during the same clinical encounter as certain colorectal cancer screening tests.  Find the updated information here.
  • CMS has released information about various aspects of future Medicare costs for program participants in calendar year 2023.  This includes a fact sheet on 2023 Medicare Parts A and B premiums and deductibles and 2023 Medicare Part D income-related monthly adjustment amounts and a news release on Medicare Part D and Medicare Advantage premiums for 2023.
  • CMS has updated its guidance to states on COVID-19 testing requirements for long-term-care facility staff and residents.  Learn about the updated guidance in CMS’s letter to state survey agencies.
  • CMS also has updated its guidance on nursing home visitation, addressing matters such as limited visiting, vaccination requirements, use of masks, and other subjects.  See the updated guidance in this CMS letter to state survey agencies.
  • CMS has announced the calendar year participants in the Medicare Advantage Value-Based Insurance Design Model.  The agency estimates that the number of Medicare enrollees covered by participating Medicare Advantage plans will increase by more than 24 percent in 2023.  Fifty-two Medicare Advantage organization will participate in the program in 2023, up from 34 in 2022.  Learn more about the participating organizations, their benefits plans, and the Medicare Advantage Value-Based Insurance Design Model from this CMS fact sheet.  CMS’s Center for Medicare and Medicaid Innovation has updated its web page on the Medicare Advantage Value-Based Insurance Design Model; find that updated page here.
  • CMS has published information about its October 2022 quarterly DMEPOS (durable medical equipment, prosthetics, orthotics, and supplies) fee schedule update.  Find it here.
  • CMS has posted updated FY 2019 and 2020 supplemental security income Medicare beneficiary data for inpatient prospective payment system hospitals in the 9th Circuit (Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, Oregon, and Washington) in the wake of the Supreme Court’s decision to uphold the agency’s interpretation of the Medicare disproportionate share hospital (Medicare DSH) statute in Azar v. Empire Health Foundation.  The data for all other hospitals is unchanged.  Find the CMS posting here.
  • CMS has posted information about ICD-10 code updates and other coding revisions to national coverage determinations that will take effect on January 1, 2023.  Find that information here.
  • The latest editions of MLN Connects, CMS’s online newsletter addressing Medicare reimbursement issues, include information about 2023 Medicare Part A and Part B premiums and deductibles; new contractors that will begin processing Medicare enrollment applications for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS); implementation of Inflation Reduction Act provisions affecting Medicare payments for biosimilars; an October update of the ambulatory surgical center payment system; and more.  Find the two latest editions of MLN Connects here and here.  Learn more about the biosimilars changes from this CMS news release.
  • CMS has approved Medicaid section 1115 demonstration initiatives in Massachusetts and Oregon that seek to test improvements in coverage, access, and quality with innovative approaches to ensure that more eligible people retain their Medicaid coverage, including by approving Oregon’s demonstration to keep children enrolled in Medicaid up to age six.  The initiatives also seek to address unmet health-related social needs, such as by giving the two states new authority to test coverage for evidence-based nutritional assistance and medically-tailored meals, clinically-tailored housing supports, and other interventions for certain beneficiaries where there is a clinical need.  Learn more about CMS’s approval of the waivers from this HHS news release.  Find additional information about the Massachusetts waiver here and about the Oregon waiver here.
  • Dr. Meena Seshamani, M.D., Ph.D., deputy administrator of CMS and director of its Center for Medicare, recently was interviewed about trends in Medicare enrollment and possible future changes in the program.  See that interview here.

Department of Health and Human Services

  • HHS and its Health Resources and Services Administration (HRSA) have awarded more than $266 million in grants to expand the community and public health workforce.  HRSA awarded $225.5 million to 83 grantees as part of its Community Health Worker Training Program, a new, multi-year program that will support training and apprenticeship to support an estimated 13,000 new community health workers.  It also awarded $40.7 million to 29 grantees through the Public Health Scholarship Program, which will offer incentives for individuals to pursue training and careers in public health.  Learn more about the purposes for which the grants were awarded and the programs of which they are a part and find links to lists of grant recipients from this HHS news release.  In addition, the White House has posted a separate fact sheet on the Community Health Worker Training Program.
  • HHS and HRSA have awarded nearly $27 million in grants to improve and expand mental health care for children.  This funding seeks to support efforts to offer timely mental health support to children and adolescents by training pediatricians and other children’s health care providers in treating mental health conditions and by providing tele-consultation to bring mental health expert support directly to pediatric primary care providers.  Learn more about the funding and how HRSA expects it to be used, and find a link to a list of grant recipients, from this HHS news release.
  • HRSA’s monthly newsletter lists a number of current funding opportunities, including for health professional student loan repayment assistance, health workforce awards, health centers, rural health care providers, and maternal and child health providers.  Find this and more in HRSA eNews.
  • HHS and its Office of Minority Health have awarded more than $4.8 million in grants to 10 organizations under its Community-Driven Approaches to Address Factors Contributing to Structural Racism in Public Health initiative.  The grant money will support a three-year program to identify new and innovative ways to address policies that may create or perpetuate health disparities and may contribute to structural racism.  Learn more about the funding and its intended purpose and find a list of grant recipients from this HHS news release.
  • HHS has announced a number of programs that seek to address the language barrier in health and human services, including $4 million in grants to 11 organizations by the agency’s Office of Minority Health for an initiative called Promoting Equitable Access to Language Services in Health and Human Services.  This three-year program covers developing and testing methods of informing individuals with limited English proficiency about the availability of language access services in health care-related settings.  Learn more about this program, the grant recipients, and other aspects of HHS’s language barrier initiative from this HHS news release.
  • HHS and its Office of Population Affairs have awarded more than $6 million for Title X Family Planning Research grants, Research-to-Practice Center grants, and Teenage Pregnancy Prevention Evaluation and Research grants as part of their objective of protecting and expanding access to reproductive health care.  The funding is intended to improve service delivery, promote the adoption of healthy behaviors, and reduce existing health disparities.  Learn more about the different categories of grants and find lists of the grant recipients from this HHS news release.
  • HHS’s Office of the National Coordinator for Health Information Technology (ONC) has awarded $2 million in grants through its Leading Edge Acceleration Projects in Health Information Technology (LEAP in Health IT) program.  These awards seek to encourage the development of methods and tools to improve care delivery, advance research capabilities, and address emerging challenges that inhibit the advancement of interoperable health IT.  Learn more about the funding program and the grant recipients and how they intend to use the funding they received from this HHS news release.
  • ONC reminds providers that October 6 marks the end a two-year glide path laid out by regulation for electronic health record information-blocking practices.  It describes in detail how electronic health record systems’ data-sharing obligations have now changed and they must make more health data available to patients in this ONC blog post.
  • HHS and its Administration for Community Living are inviting public comment on their “2022 National Strategy to Support Family Caregivers,” which is intended to serve as a national roadmap for better recognizing and supporting family and kinship caregivers of all ages, backgrounds, and caregiving situations.  Find the strategy here; additional information about it here; and additional information about the strategy and the request for comments from this Federal Register notice.  Comments are due by November 30.
  • HHS Secretary Xavier Becerra has written to selected congressional committee and subcommittee chairs to inform them that he intends to establish a new “Medicare Drug Rebate and Negotiations Group” within HHS to negotiate the price of selected prescription drugs for Medicare beneficiaries as authorized by the Inflation Reduction Act of 2022.  Learn more about HHS’s plans for the new group from this letter to congressional leaders.
  • HHS’s Office of the Inspector General has performed an audit to determine whether HHS’s and HRSA’s controls on selected Provider Relief Fund program requirements, such as those related to the requirements for submission of revenue information and attestation of rejection of payments, ensured that providers received the correct payments from the Phase 1 General Distribution.  Read about what the auditors found in this summary of their report and from the full report, “HHS’s and HRSA’s Controls Related to Selected Provider Relief Fund Program Requirements Could be Improved.”

Medicare Payment Advisory Commission (MedPAC)

Members of MedPAC met virtually last week and, along with other business, received presentations on the following subjects:

  • supporting safety-net clinicians
  • a mandated report on evaluation of a prototype design for a post-acute care prospective payment system
  • nursing facility staffing
  • a mandated report on a study of the expansion of telehealth
  • a report to Congress on Medicare inpatient psychiatric facility care
  • analysis of Medicare Part D data on drug rebates and discounts

Find links to those presentations here.

Federal Emergency Management Agency (FEMA)

FEMA has published a calendar for FY 2023 of its planned virtual tabletop exercises for presenting information about responses to various types of emergencies.  Go here for the calendar and information about participating.

Government Accountability Office (GAO)

Congressional Budget Office

The Congressional Budget Office has published the report “Policy Approaches to Reduce What Commercial Insurers Pay for Hospitals’ and Physicians’ Services.”

Congressional Research Service

The Congressional Research Service has updated its report “Medicare Graduate Medical Education Payments:  An Overview.”  The update addresses Medicare graduate medical education (GME) payments to hospitals – specifically, eligibility for these payments, what and how Medicare pays for GME, how Medicare determines the number of residents it pays for, and how much it pays for each resident.  Find the report here.

Department of Labor

The Department of Labor has announced an $80 million funding opportunity through its Nursing Expansion Grant Program to support nurse training programs designed to expand the pipeline of nursing professionals while advancing equity and creating pathways for workers to fill these jobs and improve the nation’s health care system.  These grants will support organizations that use worker-centered industry strategies to train nursing instructors or create nursing professional career pathway programs.  The program is expected to award 25 grants ranging from $1 million to $6 million.  Learn more about this funding opportunity from this Department of Labor news release and this formal funding opportunity notice.  Applications are due by January 6.


  • HHS has amended a 2008 declaration for smallpox countermeasures and countermeasures against other orthopoxviruses to emphasize that the declaration applies to monkeypox virus; to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox, monkeypox, and other orthopoxviruses in a declared emergency; and to extend the duration of the declaration.  Find HHS’s announcement of this extended declaration and learn more about it from this Federal Register notice and this HHS news release.
  • The CDC has issued a health alert to advise providers about severe manifestations of monkeypox among people who are immunocompromised due to HIV or other conditions, including information about how to diagnose and treat this condition.  Find that alert here.
  • The CDC has posted a series of updates about monkeypox-related issues.
  • The CDC has posted an updated map showing the distribution of 26,311 confirmed cases of monkeypox in the U.S. as of October 5, up from 25,132 cases on September 26.
  • The White House monkeypox response team and other federal health officials have briefed the press on the latest in the federal response to the outbreak.  Find a transcript of that briefing here.

Centers for Disease Control and Prevention

Food and Drug Administration

The FDA has released information about the risk of COVID-19 due to certain variants that are not neutralized by Evusheld, which is currently the only option for pre-exposure prevention of COVID-19.  The information includes revised guidance for providers and patients.  Learn more from this FDA notice and this revised fact sheet about the drug Evusheld,

Stakeholder Events

CDC – Clinical Call on Melioidosis – October 13

The CDC will hold a webinar to provide information about the new and evolving epidemiology of a rare and serious disease called melioidosis in the United States and to discuss what clinicians need to know to prevent, diagnose, and treat melioidosis.  The webinar will be held on Wednesday, October 13 at 2:00 (eastern); continuing education credits are available.  Learn more about the webinar and its objectives, the presenters, and how to participate from this CDC notice.

FDA – Oncologic Drugs Advisory Committee – October 28

The FDA’s Oncologic Drugs Advisory Committee will meet virtually on Friday, October 28 at 10:00 (eastern).  The general function of this committee is to provide advice and recommendations to the FDA on regulatory issues.  Learn more about the meeting, including about the docket, how to submit comments, and how to participate, from this Federal Register notice.

CDC – Healthcare Infection Control Practices Advisory Committee– November 3

The CDC’s Healthcare Infection Control Practices Advisory Committee will hold a virtual public meeting on Thursday, November 3 at noon (eastern).  The committee is charged with providing advice and guidance to various CDC offices on the practice of health care infection prevention and control; (2) strategies for surveillance, prevention, and control of infections, antimicrobial resistance, and related events in settings where care is provided; and (3) periodic updating of CDC guidelines and other policy statements regarding prevention of health care-associated infections and health care-related conditions.  Learn more about the committee, see the agenda, and find information about how to participate from this Federal Register notice.

FDA – Cardiovascular and Renal Drugs Advisory Committee – December 14

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet virtually on Wednesday, December 14 at 9:00 (eastern).  For information on the meeting’s agenda, the docket the committee has created for the meeting, how to submit comments and papers, and how to join the meeting, see this Federal Register notice.

HHS – New Technology Town Hall – December 14-15

HHS will hold a new technology town hall meeting on Wednesday, December 14 and Thursday, December 15, with both virtual sessions to begin at 9:00 (eastern), to discuss FY 2024 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system.  Interested parties may present comments, recommendations, and data regarding whether the FY 2024 new medical services and technologies applications meet the substantial clinical improvement criterion.  Learn more about the meeting and its purpose and how to participate from this Federal Register notice.