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Federal Health Policy Update for Thursday, June 10

The following is the latest health policy news from the federal government as of 3:00 p.m. on Thursday, June 10.  Some of the language used below is taken directly from government documents.

White House

Health Policy News

  • The White House has released a memo titled “What We Urge You To Do To Protect Against The Threat of Ransomware.”  This memo addresses the growing number and size of ransomware incidents and calls upon government and the private sector to take steps to protect their organizations from this growing threat.  The memo also outlines the federal government’s recommended best practices.  Find the memo here.

Centers for Medicare & Medicaid Services

COVID-19

Health Policy News

  • CMS has published the latest edition of MLN Connects, its online publication.  For articles about prior authorization for hospital outpatient departments, ICD-10 PCS procedure codes for FY 2022, HCPCS codes subject to and excluded from CLIA amendments, Medicare’s quarterly compliance newsletter, and more, go here.

Department of Health and Human Services

COVID-19

  • HHS Secretary Xavier Becerra has written to providers to remind them that COVID-19 tests and vaccines are to be “…free for any individual living in the United States, regardless of their insurance or immigration status.”  The letter reminds providers of how they may seek reimbursement for their testing and vaccine administration costs from entities other than their patients.  See the HHS announcement of this reminder from Secretary Becerra and the letter to providers.
  • HHS announced that the federal government will purchase approximately 1.7 million courses of the investigational antiviral treatment molnupiravir (MK-4482), which is used to treat COVID-19, pending emergency use authorization or approval by the FDA.  The drug is currently in phase 3 trials.  The value of the purchase is $1.2 billion.  See the HHS announcement here.
  • HHS’s Office of the Assistant Secretary for Preparedness and Response has updated its COVID-19 Behavioral Health Resources page to help address health care professional stress and resilience, including self-care resources and combating compassion fatigue.

Occupational Safety and Health Administration

  • OSHA posted a new emergency rule, soon to be published in final form, describing new steps that health care entities must take to protect their workers from COVID-19.  The steps address the use of personal protective equipment, ventilation, social distancing, time off for vaccines, and more.  Learn more from information posted on the OSHA web site and from the new emergency rule itself.  The rule takes effect upon official publication.

Centers for Disease Control and Prevention

COVID-19

National Institutes of Health

  • The NIH announced that a clinical trial is under way in five U.S. cities to determine whether delivering integrated health services through mobile clinics can improve HIV and substance use outcomes among people with opioid use disorder who inject drugs.  Learn more here.

Stakeholder Events

Friday, June 11 – FDA
Identification of Medicinal Products: Path to Global Implementation
Friday, June 11 at 1:00 – 2:30 pm ET  Click here to learn more
FDA will present updates on the Identification of Medicinal Products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form and pharmaceutical identification.

Friday, June 11 – FDA
Identification of Medicinal Products:  Path to Global Implementation
Friday, June 11 at 1:00 – 2:30 pm ET   Click here to learn more
The FDA will present updates on the identification of medicinal products standards development and implementation with an emphasis on international collaboration, pilot projects on substance, dosage form, and pharmaceutical identification.

Friday, June 18 – Office of the National Coordinator for Health Information Technology (ONC)
ONC Workshop: Advancing Social Determinants of Health Data Use and Interoperability for Achieving Health Equity
Friday, June 18 at 10:00 am – 4:30 pm ET  Click here to learn more
This workshop will explore existing and emerging data standards, tools, approaches, policies, models, and interventions for advancing the use and interoperability of non-clinical health data for individual and community health improvement.  It will enable varying perspectives of health policy-makers and health improvement implementers to highlight inventive solutions, share challenges, and review ideas on data modernization to advance health equity.  The workshop offers introductory content as well as deep exploration of key topics as part of social determinants of health IT data use and interoperability including facilitated, expert stakeholder engagement.

Tuesday, June 22 – FDA
FDA Drug Topics: Overview of Risk Evaluation and Mitigation Strategies (REMS) for Health Care Providers
Tuesday, June 22 at 1:00 – 2:15 pm ET  Click here to learn more
This webinar will provide an overview of REMS and discuss how the REMS safety requirements affect prescribers, dispensers and patients.  Participants should gain an understanding of the REMS authorities, how REMS are implemented, and the entities that provide oversite and support.  REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.