The following is the latest health policy news from the federal government for the week of January 23 to February 6.  Some of the language used below is taken directly from government documents.


  • Pharmaceutical companies may restrict the ability of providers to use specialty and community pharmacies to distribute 340B-covered drugs, a federal appeals court has decided.  See the court’s ruling here.

Centers for Medicare & Medicaid Services

  • CMS has revised its fact sheets about COVID-19 public health emergency waivers and flexibilities for different types of providers, updating which waivers and flexibilities have already been terminated, which have been made permanent, and which will end at the end of the public health emergency on May 11.  Find the updated fact sheets here.
  • CMS has written to state Medicaid officials about Medicaid continuous enrollment changes, conditions for receiving the Families First Coronavirus Response Act temporary increase in federal Medicaid matching funds, and enforcement provisions in the Consolidated Appropriations Act of 2023.  Find the letter here.
  • CMS has announced a marketplace special enrollment period (SEP) for qualified individuals and their families who lose Medicaid or CHIP coverage due to the end of continuous Medicaid enrollment.  This SEP will enable individuals and families in markets served by to enroll in marketplace health insurance coverage outside of the annual open enrollment period.  CMS will update so marketplace-eligible consumers who submit a new application or update an existing application between March 31, 2023 and July 31, 2024 and attest to a last date of Medicaid or CHIP coverage within the same time period are eligible for this SEP.  Consumers who are eligible for this SEP will have 60 days after they submit their application to select a marketplace plan with coverage that starts the first day of the month after they select a plan.  Learn more from this CMS notice.
  • CMS has published two notices designed to help hospitals fulfill their 2023 Promoting Interoperability Requirements.  For further information, see “Learn About This Year’s Medicare Promoting Interoperability Program Requirements with the 2023 Program Specification Sheets” and “Updated 2023 CMS QRDA I Implementation Guide (IG), Schematron, and Sample Files for Hospital Quality Reporting.”
  • CMS has released the Calendar Year 2024 Advance Notice for the Medicare Advantage and Part D Prescription Drug Programs to update payment policies for these programs.  The proposed net payment impact, with an effective growth rate of 2.09 percent and a series of adjustments, is an expected average increase in revenue of 1.03 percent.  The notice also outlines several changes that will go into effect or be in effect on January 1, 2024, including the continuation of reduced cost-sharing for insulin; elimination of cost-sharing for recommended, preventive vaccines; the elimination of cost-sharing for Part D prescription drugs in the catastrophic phase; and expansion of eligibility for full cost-sharing and premium subsidies under the low-income subsidy program.  Learn more from this CMS news release; a CMS fact sheet; and the formal advance notice.  The deadline for submitting comments is March 3.
  • CMS has published a final regulation governing the Medicare Advantage Risk Adjustment Data Validation (RADV) program that the agency uses to recover improper risk adjustment payments made to Medicare Advantage plans.  The RADV final rule seeks to help CMS protect the Medicare Advantage program by addressing instances where Medicare paid Medicare Advantage organizations more than they otherwise should have received because the medical diagnoses submitted for risk adjustment payment were not supported in beneficiaries’ medical records.  This rule establishes an audit methodology in which CMS will extrapolate RADV audit findings beginning with payment year 2018.  CMS is expected to recover billions in overpayments.  Learn more from this CMS news release; a CMS fact sheet; and the final rule itself.
  • CMS has written to state survey agencies with information about the new Rural Emergency Hospital (REH) designation.  The CMS memo provides guidance regarding the REH enrollment and conversion process for eligible facilities, an FAQ, and a newly developed State Operations Manual Appendix (Appendix O) with survey procedures and conditions of participation regulatory text.  Find the memo here.
  • CMS has posted information about how it will adjust payments to hospitals for purchasing NIOSH-approved surgical N95 respirators.  Find it here.
  • CMS has posted information about its quarterly update for its clinical laboratory fee schedule and laboratory services subject to reasonable charge payment.  Find it here.
  • CMS has published new editions of MLN Connects, its weekly online newsletter with information about Medicare reimbursement issues.  The latest issues includes features on changes coming soon to the Medicare PECOS (Provider Enrollment, Chain, and Ownership System) through which providers enroll to become Medicare providers and other regulatory changes in provider enrollment.  Find the two latest issues of MLN Connects here and here.
  • CMS is inviting interested parties to submit nominations to fill vacancies on its Advisory Panel on Outreach and Education, which make recommendations to CMS and HHS on the implementation of national Medicare, Medicaid, Children’s Health Insurance Program and Health insurance marketplace outreach and education programs.  Learn more about the panel and the nominating process from this CMS announcement, which includes a link to a formal Federal Register notice.  The deadline for submitting nominations is February 24.
  • In a letter to the New England Journal of Medicine, the leaders of several CMS centers have expressed their intention to consolidate the agency’s various quality programs and “…move toward a building-block approach:  a ‘universal foundation’ of quality measures that will apply to as many CMS quality-rating and value-based care programs as possible, with additional measures added on, depending on the population or setting.”  Go here to see that letter and learn more about CMS’s intentions.
  • CMS has published a quarterly notice listing its manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2022 that address Medicare, Medicaid, and other programs administered by CMS.  Find the listing in this Federal Register notice.

Department of Health and Human Services

  • HHS and the departments of Labor and the Treasury have proposed rules to strengthen access to birth control coverage under the Affordable Care Act.  Under that law, most health insurance plans are required to offer coverage of birth control with no out-of-pocket costs.  The proposed rule creates a means for individuals enrolled in plans arranged or offered by objecting entities to make their own choice to obtain contraceptive services directly through a willing contraceptive provider without any cost.  Learn more about the proposed rule from this HHS news release; this fact sheet; and the proposed rule itself.  The deadline for comments is April 3.
  • HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) has created a Services Grant Program for Residential Treatment for Pregnant and Postpartum Women, which seeks to provide comprehensive services for pregnant and postpartum women with substance use disorders across the continuum of residential settings that support and sustain recovery.  Learn more about the program and how to apply for funding from this SAMHSA announcement.  The deadline for applying for $11.6 million in grants is March 27.
  • HHS’s Office of Information Security has published a new edition of its HC3:  Healthcare Cybersecurity Bulletin, with information about ransomware attacks, data breaches, and other cyber threats and vulnerabilities currently facing health care organizations.  Find the bulletin here.
  • Another bulletin from that office alerts health care interests to the group “‘KillNet,” which has targeted the U.S. health care industry in the past and is actively targeting the health and public health sector at this time.  The group is known to launch distributed denial-of-service (DdoS) attacks and operates multiple public channels aimed at recruitment and garnering attention from these attacks.  The notice describes the attacks and offers mitigation suggestions.  Find the notice here.
  • HHS’s Health Resources and Services Administration (HRSA) has awarded $12.5 million to five organizations in California, $7.5 million to three organizations in Texas, and $5 million to two organizations in New York to help primary care physicians meet families’ mental health needs.
  • HRSA has updated its Provider Relief Fund FAQ with three revised answers that address Form 990s that providers will receive for 2022 activity.  The revised answers are all on page 6 and are marked “Modified 1/30/2023.”  Find the updated FAQ here.
  • The deadline for providers that believe their Provider Relief Fund Phase 4 or American Rescue Plan Rural payment was not calculated correctly to submit a request for recalculation of that payment is February 21.  Go here to learn more about the limits of a reconsideration request and how to apply for it.
  • HHS and HRSA have awarded nearly $11 million to 22 HRSA-funded health centers to improve access to cancer screenings and early detection services for underserved communities.  The grants are part of the administration’s “cancer moonshot.”  Learn more about the program and how the money will be used and find a list of grant recipients from this HHS news release.
  • HHS’s Office of the National Coordinator for Health Information Technology (ONC) has published a data brief describing the state of interoperability among hospitals as of 2021.  The brief presents trends on information exchange and the availability and use of information at the point of care; highlights key barriers to interoperability; outlines the methods hospitals use to exchange health information; and describes their participation in national networks and health information exchanges (HIEs).  Find the ONC data brief here.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) seeks nominations for new members of the U.S. Preventive Services Task Force.  Candidates must demonstrate expertise and national leadership in critical evaluation of research, clinical preventive services, and implementation of evidence-based recommendations in clinical practice.  For consideration for positions beginning in 2024, applications must be submitted by March 15.  Learn more from this AHRQ announcement.
  • HHS’s Administration for Strategic Preparedness and Response (ASPR) has updated its FAQ on opioids.  Find the revised document here.
  • HHS and its Indian Health Service have awarded $139 million for the Special Diabetes Program for Indians to provide diabetes prevention and treatment services for American Indian and Alaska Native communities.  Learn more from this HHS news release.

Centers for Disease Control and Prevention

Food and Drug Administration

  • Because of changes in the predominant strain of COVID-19 currently in the U.S., the FDA has withdrawn its emergency use authorization for the use of Evusheld to treat the virus.  The agency urges providers to keep their current supply of Evusheld in case the predominant strain changes – as it has in the past – and outlines other drugs that can be prescribed in its place.  Learn more from this FDA news announcement.
  • The FDA has revised its emergency use authorizations for the COVID-19 therapeutics Paxlovid and Lagevrio so the drugs may now be prescribed for patients who have COVID-19 but do not have a positive test for the virus.  See the FDA’s revised emergency use authorization letter for Paxlovid here and the Lagevrio letter here.

National Institutes of Health

  • The proportion of opioid overdose deaths involving buprenorphine, a medication used to treat opioid use disorder, did not increase in the months after prescribing flexibilities were put in place during the COVID-19 pandemic, according to a new study.  Learn more from this NIH news release.

Medicare Payment Advisory Commission (MedPAC)

  • MedPAC and MACPAC have released “Beneficiaries Dually Eligible for Medicare and Medicaid,” which presents information on the demographic and other personal characteristics, expenditures, and health care utilization of individuals who were dually eligible for Medicare and Medicaid coverage in 2020.  The book compares subgroups of dual-eligible beneficiaries, including those with full versus partial benefits and those under age 65 versus those ages 65 and older.  It also compares dual-eligible beneficiaries with non-dual-eligible Medicare and Medicaid beneficiaries.  Find the data book here.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has written to CMS in response to that agency’s notice of proposed rulemaking outlining benefit and payment parameters for qualified health plans offered on health insurance exchanges.  MACPAC offered comments on opportunities to improve access to and enrollment in Medicaid and the State Children’s Health Insurance Program (CHIP).  In its letter, MACPAC encouraged CMS to consider other steps it can take to reduce gaps and expressed concern that beneficiaries submitting Medicaid or CHIP renewal forms also must submit new exchange applications.  MACPAC urged CMS to do more to align eligibility and enrollment policies with the statutory requirements for streamlined coverage.  Learn more from MACPAC’s letter to CMS.
  • MACPAC has written to HHS in response to a notice of proposed rulemaking on the confidentiality of substance use disorder (SUD) patient records.  In the letter, MACPAC expressed support for HHS’s efforts to improve the ability of patients and providers to share SUD information while also strengthening patient rights and protections but expressed concern about the stricter consent requirements proposed for intermediaries, such as health information exchanges and accountable care organizations, and HHS’s decision to implement new anti-discrimination protections in separate rulemaking.  Learn more from MACPAC’s letter to HHS.

Government Accountability Office (GAO)

Stakeholder Events

CMS – Hospital/Quality Initiative Open Door Forum – February 7

CMS will hold a hospital/quality initiative open door forum on Tuesday, February 7 at 2:00 (eastern).  Subjects on the agenda include upcoming wage index guidelines, the distribution of additional residency positions, modernizing CMS’s payment system software, and the skilled nursing facility quality reporting program.  To see a more detailed version of the agenda and for information on how to join the event, which will be held by conference call, see this CMS notice.

CMS – Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule Educational Session – February 9

CMS’s Office of Burden Reduction and Health Informatics is holding a virtual education session on the Advancing Interoperability and Improving Prior Authorization Processes proposed rule on February 9 at noon (eastern).  The session is directed to administrative, health IT, and government affairs professionals.  Participants must register by February 8.  Go here to register.

NIH – Health Disparities – February 9

The NIH will hold a webinar on “The Intractability of Health Disparities: Where Do We Go From Here?” on Thursday, February 9 at 2:00 (eastern).  This webinar will address the pervasiveness of health disparities among Black people and the social and structural determinants that underlie health inequities and describe the historical role of science and scientists in creating and perpetuating racism and racial health inequities.  The webinar also will explain the importance of systems-level change in creating and integrating equitable and inclusive policies and initiatives to achieve health equity.  Go here for further information about the webinar and how to join it.

HRSA – Data Bank Administrator Training Webinar – February 22

HHS’s Health Resources and Services Administration and the National Practitioner Data Bank will hold a webinar on Wednesday, February 22 at 2:00 (eastern) to explain the roles and responsibilities of data bank administrators and National Practitioner Data Bank account management.  The webinar will include a Q&A session with National Practitioner Data Bank staff members.  Participants are eligible for continuing education credits.  Go here for further information and to register to participate.

MedPAC – Commissioners’ Meeting – March 2-3

MedPAC’s commissioners will hold their next public meeting on Thursday, March 2 and Friday, March 3.  An agenda for the meeting and information about participation are not yet posted, but when they are they will be here.

MACPAC – Commissioners’ Meeting – March 2-3

MACPAC’s commissioners will hold their next public meeting on Thursday, March 2 and Friday, March 3.  An agenda for the meeting and information about participation are not yet posted, but when they are they will be here.

FDA – Workshop on Fatal Overdoses, Product Development, and Public Health Interventions – March 8-9

The FDA, in partnership with the Reagan-Udall Foundation for the FDA, will hold a two-day virtual public meeting entitled “Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose.”  The event, to be held on Wednesday, March 8 and Thursday, March 9 at 1:00 (eastern) both days, is for stakeholders, including people who use drugs, their families, harm reduction programs, clinicians, academic researchers, and federal partners.  Go here to learn more about the event and how to register to participate.