Federal Health Policy Update for Monday, January 24

The following is the latest health policy news from the federal government as of 3:00 p.m. on Monday, January 24.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

  • The reconsideration window for Provider Relief Fund Phase 4 payments and American Rescue Plan rural hospital payments will open on February 1, 2022, at which time providers will be able to request reconsideration of their payments.  This process is intended only for providers that believe their payment was not calculated correctly.  They will not have an opportunity to submit an application if they missed a deadline; will not be able to revise or correct their original application; and will not be able to request reconsideration that would require a change to payment methodology or policy.  Learn more from this Provider Relief Fund web page.

White House

Centers for Medicare & Medicaid Services

COVID-19

Department of Health and Human Services

COVID-19 Update

Health Policy Update

  • HHS has awarded $6.6 million through the Title X family planning program to address the need for family planning services where restrictive laws and policies have affected access to reproductive health services.  These competitively awarded grants were made to entities in seven states.  Learn more about the program, how the funding will be used, and to whom it was awarded from this HHS news release.
  • In support of this objective, HHS has launched an agency-wide task force, the HHS Reproductive Healthcare Access Task Force, that consists of senior-level HHS officials who have been designated by their respective agencies to identify and coordinate activities across the department to protect and bolster access to essential sexual and reproductive health care, including implementation of activities identified in the White House National Strategy on Gender Equity and Equality.  The working group activities will focus on advancing quality, access, and equity for reproductive health, rights, and justice and include coordinating federal interagency policy-making, program development, and outreach to address barriers affecting individuals and communities seeking reproductive health care.  Learn more about the work the task force is expected to undertake from this HHS news release and from this HHS statement.
  • HHS’s Office of the National Coordinator for Health Information Technology (ONC) has released a Request for Information (RFI) seeking input from the public on electronic prior authorization standards, implementation specifications, and certification criteria that could be adopted within the ONC Health IT Certification Program.  Responses to this RFI may be used to inform potential future rulemaking to better enable providers to interact with health care plans and other payers for the automated, electronic completion of prior authorization tasks.  Learn more from this HHS news release and the RFI itself.  Stakeholder comments are due March 25.
  • HHS’s Agency for Healthcare Research and Quality (AHRQ) has published a data brief on the most frequent reasons for emergency department visits in 2018.  Find it here.

Centers for Disease Control and Prevention

Food and Drug Administration

  • The FDA has revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.   Recent data shows that these treatments are highly unlikely to be active against the omicron variant.  Learn more from this FDA statement.
  • The FDA has taken two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease.  Those actions are:
    • The agency expanded the approved indication for remdesivir to include its use in adults and pediatric patients (12 years of age and older who weigh at least 88 pounds) with positive results of direct COVID-19 testing, are not hospitalized, have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.
    • It revised its emergency use authorization for remdesivir to authorize the drug for treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms, who have tested positive for COVID-19, who are not hospitalized and have mild-to-moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization of death.

Learn more from the following resources:

– an FDA news release;

– revised prescribing information for remdesivir;

– the revised emergency use authorization for the drug; and

– a revised FDA FAQ on remdesivir.

  • The FDA has updated its device shortage list to include all blood specimen collection tubes (product codes GIM and JKA) to the testing supplies and equipment/specimen collection category on the device shortage list.  The list previously included sodium citrate (light blue top) tubes only.  The device shortage list reflects the categories of devices the FDA has determined to be in short supply at this time.  The FDA has published an FAQ explaining the shortage and its decision.

National Institutes of Health

  • COVID-19 was initially identified as a respiratory virus but it can affect the entire body, including the nervous system, and this has implications for patients with long COVID, according to the NIH.  Learn more from this NIH news release.
  • COVID-19 vaccination does not affect the chances of conceiving a child, according to a study of more than 2000 couples that was funded by the National Institutes of Health.  Researchers found no differences in the chances of conception if either male or female partner had been vaccinated, compared to unvaccinated couples, but it did find that couples had a slightly lower chance of conception if the male partner had been infected with COVID-19 within 60 days before a menstrual cycle, suggesting that COVID-19 could temporarily reduce male fertility.  Learn more from this NIH news release.
  • Survey data of more than 3000 adolescents ages 11-14 recorded before and during the early months of the COVID-19 pandemic in 2020 found that supportive relationships with family and friends and healthy behaviors, like engaging in physical activity and better sleep, appeared to shield against the harmful effects of the pandemic on adolescents’ mental health.  Learn more from this NIH news release.

Medicaid and CHIP Payment and Access Commission (MACPAC)

  • MACPAC has posted a summary of its January 21-22 public meetings and provided links to the presentations made during those meetings.  Find them here.

Congressional Budget Office (CBO)

Stakeholder Events

NIH National Institute of Nursing Research – January 25

NIH’s National Institute of Nursing Research, which supports basic and clinical research that seeks to establish a scientific basis for the care of individuals, will hold an open session of its National Advisory Council for Nursing Research on January 25 at 11:00 a.m.  For a meeting agenda and information on how to view the meeting, go here.