The following is the latest health policy news from the federal government as of 2:30 p.m. on Thursday, April 28.  Some of the language used below is taken directly from government documents.

White House

  • The White House has announced a series of steps designed to increase the availability of oral treatments for COVID-19.  Those steps include nearly doubling the number of places oral antivirals are available in the coming weeks; launching a new effort to establish federally-supported test-to-treat sites; supporting medical providers with more guidance and tools to understand and prescribe treatments; and communicating to the public that safe, effective treatments are widely available.  Learn more from this White House fact sheet and from the transcript of a briefing the White House held for reporters on this initiative.
  • White House press secretary Jen Psaki and White House COVID-⁠19 response coordinator Dr. Ashish Jha recently briefed the press on several aspects of the administration’s response to COVID-19.  Find a transcript of that briefing here.
  • The White House has released its “National Drug Control Strategy,” which it says “…proposes bold, targeted, and consequential actions to bend the curve on overdose deaths in the immediate term and reduce drug use and its damaging consequences over the longer term.”

Department of Health and Human Services

Health Policy News

  • HHS has announced new measures that seek to enable consumers to find more easily the health care coverage on that best meets their needs.  The measures consist of:
    • standardized plan options
    • new network adequacy requirements
    • health equity components
    • increasing the value of coverage for consumers
    • increasing access for consumers and removing barriers to coverage
    • expanding access to essential community providers by raising the essential community provider threshold from 20 percent to 35 percent
    • further streamlining

Learn more from the following resources:

an HHS news release 

an HHS fact sheet 

the new final regulation

  • HHS and the White House have issued a “call to action” for health care stakeholders to commit to tackling the climate crisis through a new initiative aimed at reducing emissions across the health care sector.  The voluntary pledge asks participants to, at a minimum, commit to:  (1) reducing their organization’s emissions (by 50 percent by 2030 and to net zero by 2050) and publicly reporting on their progress; (2) completing an inventory of supply chain emissions; and (3) developing climate resilience plans for their facilities and communities.  It also asks them to designate an executive lead for this work.  Learn more from this HHS news release and find additional information, including an FAQ and forms for submitting pledges to participate, on this new HHS web page.

Centers for Medicare & Medicaid Services

Health Policy News

  • CMS has issued a proposed regulation to update Medicare enrollment and eligibility rules to expand coverage for people with Medicare and advance health equity.  This proposed rule would provide Medicare coverage the month immediately after enrollment, thereby reducing the uninsured period, and expand access through Medicare special enrollment periods that would affect those who have recently lost their Medicaid coverage, those who have experienced natural disasters or emergencies, and others.  It also would enable eligible beneficiaries to receive Medicare Part B coverage without a late enrollment penalty and target people undergoing kidney transplants and dialysis for faster access to coverage and improved benefits.  CMS believes these proposed changes will make it easier for people to enroll in Medicare and eliminate delays in coverage.  Learn more from this CMS news release; from an accompanying CMS fact sheet; and from the proposed rule itself.  Comments are due by June 27.
  • As part of its effort to prepare providers to return to regular operations after COVID-19, CMS has posted a webinar from its Medicaid and CHIP learning collaborative on Medicaid and CHIP eligibility and enrollment unwinding data reporting and submission.  Find the recorded webinar here and the presentation that accompanied that webinar here.
  • The latest edition of MLN Connects, CMS’s online newsletter on Medicare reimbursement matters, includes features on a new tool for determining patient eligibility for selected Medicare-covered services; information about providers that have not updated their names and NPI numbers in the National Plan and Provider Enumeration System and how providers can address this; a reminder that the deadline for physicians, teaching hospitals, physician assistants, and advance practice nurses to review their Open Payments data is May 15; MS-DRG updates effective October 1, 2020; and more.
  • On December 27, 2021 CMS published a final rule with comment period (CMS-1752-FC3) that implemented changes in Medicare graduate medical education (GME) payments for teaching hospitals.  The rule implements legislative changes to direct GME and indirect medical education (IME) payments to teaching hospitals that were included in the Consolidated Appropriations Act of 2021.  Now, CMS has posted guidance to hospitals and instructions to the MACs on how to review and implement requests to increase hospitals’ IME and direct GME interim rates (and eventually, rural track FTE limitations) due to participating in new rural track programs (RTPs) and/or adding clinical participating sites to existing RTPs.

Centers for Disease Control and Prevention

  • The CDC has issued a health alert to update providers, public health departments, and the public about the availability and use of recommended therapies for COVID-19 and to advise against using unproven treatments that pose known or potential harm for outpatients with mild to moderate COVID-19.  The advisory includes information about drugs created to treat COVID-19 and warns against prescribing and using antibiotics and steroids, which it says offer no benefits for COVID-19 patients and can harm some patients.  Learn more from this CDC advisory announcement.
  • The CDC has posted a new study analyzing COVID-19 age-adjusted death rates by race and ethnicity for 2020 and 2021.

Food and Drug Administration

  • The FDA has expanded its approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least three kilograms (about seven pounds) with positive results of COVID-19 testing who are hospitalized or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.  This action makes remdesivir the first approved COVID-19 treatment for children less than 12 years of age.  Learn more from this FDA announcement.
  • The FDA has announced that it is seeking public comment on a potential change that would require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back envelopes and that would require pharmacists to provide patient education on safe disposal of opioids.  This potential modification of the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy would, the FDA writes, “… provide a convenient, additional disposal option for patients beyond those already available such as flushing, commercially available in-home disposal products, collection kiosks and takeback events.”  Learn more about the proposal in this FDA news release and this Federal Register notice, which explains the proposal further and advises stakeholders on how to submit comments, which are due by June 21.
  • The FDA invites industry organizations interested in participating in the selection of a non-voting industry representative to serve on the Pediatric Advisory Committee to notify the agency in writing.  The FDA also seeks nominations for non-voting industry representatives to serve on the Pediatric Advisory Committee.  Learn more in this Federal Register notice.  Letters of interest are due by May 31.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has written to the chairs and ranking members of the Senate Finance Committee and House Energy and Commerce Committee and the Secretary of the U.S. Department of Health and Human Services about two reports issued recently by the Secretary.  The first was a response to a 21st Century Cures Act directive that the Secretary study Medicaid coverage for beneficiaries age 21–64 receiving services in institutions for mental diseases (IMDs) as in-lieu-of services through managed care and the second was a report required by the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act on best practices for the use of prescription drug monitoring programs (PDMPs) and for protecting the privacy of Medicaid beneficiary information in PDMPs.  Find the MACPAC letter here.
  • CMS has implemented its “Financial Alignment Initiative” to improve care and reduce costs for approximately 12.2 million low-income seniors and people with disabilities who are dually eligible for Medicare and Medicaid and to improve coordination between Medicaid and Medicare.  As of January 2022, 11 states participated in the Financial Alignment Initiative.  In the new issue brief “Financial Alignment Initiative for Beneficiaries Dually Eligible for Medicaid and Medicare” MACPAC describes the overall design of the initiative, compares key provisions of the approaches in the capitated model demonstrations in the participating states, and provides updated information on enrollment, plan, state participation in the demonstration, and changes in payment methodologies.

Stakeholder Events

CDC – Clinician Outreach and Communication Activity – May 5

The CDC’s Clinical Outreach and Communication Activity organization will hold a virtual webinar on evaluating and supporting patients presenting with cognitive symptoms following COVID-19 on Thursday, May 5 at 2:00 (eastern).  Go here to learn more about the webinar, the presenters, and how to participate.

CDC – The Inpatient Rehabilitation Facility and Long-Term Care Hospital  Updated Guidance Virtual Training Program – May 9 and June 15-16

CMS will present virtual training to review the updated guidance for the Inpatient Rehabilitation Facility – Patient Assessment Instrument (IRF-PAI) 4.0 and the LTCH Continuity Assessment Record and Evaluation (CARE) Data Set (LCDS) 5.0 for providers in the IRF and LTCH settings.  This training is part of the agency’s effort to ensure that IRF and LTCH providers understand and can comply with changes in reporting requirements associated with the IRF and LTCH quality reporting programs that go into effect on October 1, 2022.  A major focus of this training will be on the cross-setting implementation of the standardized patient assessment data elements being introduced in 2022 to ensure more consistent reporting and evaluation across post-acute-care settings.  The training will consist of two parts.

  • Beginning May 9, CMS will offer recorded training videos that deliver foundational knowledge necessary to understand the new items and guidance.  These videos are intended to be reviewed in advance of the live event.
  • On June 15–16, CMS will conduct live, virtual workshops to provide coding practice on the items covered in the Part 1 videos.  These live sessions will take place each day between 1:00 and 5:00 (eastern).

Go here to register to participate.

HHS/Health Resources and Services Administration – Telehealth – May 16-17

HRSA will hold a virtual national telehealth conference on Monday, May 16 and Tuesday, May 17.  Over the course of two days, experts and leaders in the field will examine the evolution of telehealth, discuss its place in an overall, integrated health care delivery model, and review the lessons learned during the COVID-19 pandemic to inform the future of telehealth.  To learn more about the conference, see its agenda, and register to participate, go here.

CDC – Board of Scientific Counselors, Center for Preparedness and Response – June 1 and 2

The Board of Scientific Counselors of the CDC’s Center for Preparedness and Response will meet virtually on Wednesday, June 1 at 1:00 p.m. and Tuesday, June 2 at 1:00 p.m. to 4:30 p.m. (eastern).  This board is charged with providing advice and guidance to the Secretary, Department of Health and Human Services, the Assistant Secretary for Health, the Director of the CDC, and the Director of the Center for Preparedness and Response concerning strategies and goals for the programs and research within the Center for Preparedness and Response, monitoring its overall strategic direction and focus, and administration and oversight of peer review for its scientific programs.  Learn more about the board, the agenda for the meetings, and how to participate from this Federal Register notice.

CDC – Community Preventive Services Task Force – June 8-9

The CDC’s Community Preventive Services Task Force will meet virtually on Wednesday, June 8 and Thursday, June 9 beginning at 10:00 (eastern) on both days.  The task force works to identify community preventive programs, services, and policies that increase health, longevity, save lives and dollars, and improve Americans’ quality of life, and during its meetings it considers the findings of systematic reviews of existing research and practice-based evidence and issues recommendations.  Individuals interested in participating must register to do so and then will receive information about how to join the meeting.  Find the meeting’s agenda and registration information in this Federal Register notice.

CMS – Clinical Laboratory Codes and Fees Public Meeting – June 23

CMS will hold a public meeting 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 2023.  The meeting is scheduled for Thursday, June 23 at 9:00 (eastern).  To learn more about the meeting, about submitting comments and presentations for the meeting, and about joining the meeting virtually, see this Federal Register notice.

CMS – Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests – July 18 and 19

CMS’s Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests will meet virtually on Monday, July 18 and Tuesday, July 19 beginning at 9:00 on both days.  The purpose of the panel is to advise HHS and CMS on issues related to clinical diagnostic laboratory tests.  Learn more about the panel and how to participate in the meeting from this Federal Register notice.