The following is the latest health policy news from the federal government as of 2:45 p.m. on Tuesday, June 8.  Some of the language used below is taken directly from government documents.

White House

Health Policy News

• The White House, HHS, HHS’s Office of the Assistant Secretary for Preparedness and Response, and the FDA have announced a series of policy recommendations to address vulnerabilities in U.S. pharmaceutical supply chains.  Under one of these recommendations, HHS, under the Defense Production Act and building on current public-private partnerships, will establish a public-private consortium for advanced domestic manufacturing of essential medicines production.  The consortium’s first task will be to select 50-100 critical drugs, drawn from the FDA’s essential medicines list, to be the focus of this effort.  HHS also will make an initial commitment of approximately $60 million from the American Rescue Plan to develop novel platform technologies to increase domestic manufacturing capacity for active pharmaceutical ingredients.  Learn more about this initiative from the following resources:
  • An HHS news release that focuses on the pharmaceutical aspect of this endeavor
  • A White House fact sheet on this new effort to address various supply chain challenges
  • The report of an administration review of supply chain issues that led to this initiative

COVID-19

• The White House has posted transcripts of the June 3 and June 8 press briefings given by its COVID-19 response team and public health officials.

Centers for Medicare & Medicaid Services

COVID-19

• CMS has published three resources for facilitating the administration of COVID-19 tests in schools:
  • “Quick Start Guide to CLIA Certification for COVID-19 Testing in Schools”
  • “How to Get Certification for In-School COVID-19 Testing”
  • “Achieving Quality COVID-19 Testing in Schools” (an infographic)

Health Policy News

• According to reports, Jon Blum will join CMS as principal deputy administrator, the same position he held during the Obama administration.  Also, Erin Richardson, currently a lobbyist for the Federation of American Hospitals, will join CMS as administrator Chiquita Brooks-LaSure’s chief of staff.  Ms. Richardson served on the White House Domestic Policy Council during the Obama administration.
• CMS has published a guide to using the health-related social needs screening tool from the Accountable Health Communities Model.  Health-related social needs are individual-level, adverse social conditions that negatively affect individuals’ health care and are distinguished from social determinants of health.  Find the guide here.
• CMS has issued a 2021 navigator notice of funding opportunity that will make $80 million in grant funding available to navigators in states with a federally-facilitated marketplace for the 2022 plan year.  Go here to see CMS’s announcement about the funding and go here to see formal notice of the funding opportunity.  Applications are due July 6.

Department of Health and Human Services

Health Policy News

• HHS’s Office of the Assistant Secretary for Preparedness and Response has issued a warning describing current vulnerabilities, including to ransomware threats, for selected health care information systems.  Find that notice here.

Centers for Disease Control and Prevention

COVID-19

• A CDC study has concluded that mRNA COVID-19 vaccines reduce the risk of infection by 91 percent for fully vaccinated people and that vaccination makes illness milder and shorter for the people who are vaccinated but still get COVID-19.  Learn more here.
• The CDC has published research on decreases from September 1, 2020 through May 1 of this year in the numbers of COVID-19-related cases, emergency room visits, hospital admissions, and deaths among older adults since the introduction of COVID-19 vaccines.  See the report here.
• The CDC has posted research on the hospitalization of adolescents between the ages of 12 and 17 who have been diagnosed with COVID-19.  The report found that about one-third of such hospitalized adolescent patients needed to be admitted to hospital ICUs and some required mechanical ventilation.
• The CDC has posted information about how operators of community clinics can arrange to work with federal pharmacy partners to administer COVID-19 vaccines.
• The CDC has updated its information on safe operations in light of the COVID-19 pandemic for institutions of higher education.
• The CDC has updated its guidelines for laboratories for safe handling of COVID-19 and COVID-19-suspected specimens.
• The CDC has added emergency department visit data to its daily COVID-19 data tracker.
• The CDC has added a health equity landing page to its COVID-19 data tracker.

Food and Drug Administration

COVID-19

• The FDA reissued a letter of authorization for REGEN-COV (Casirivimab and Imdevimab) treatment for COVID-19 with changes that address dosage, the proportions for combining the two drugs, and methods for administering them.  For further information, consult the following resources:
  • The letter of authorization
  • A letter from the FDA to providers with prescribing information
  • A fact sheet for providers
  • A fact sheet for patients, parents, and caregivers
  • An updated FAQ on the revised emergency use authorization
• The FDA has approved an abbreviated new drug application for albuterol sulfate inhalation aerosol 90 mcg (base)/actuation.  Albuterol sulfate inhalation aerosol is used for the treatment or prevention of bronchospasm (narrowing of the airways) in patients four years of age and older with reversible obstructive airway disease (such as asthma) and for the prevention of exercise-induced bronchospasm in patients four years of age and older.  It is used in the treatment of COVID-19 patients.
• The FDA has updated its SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests web page.

Health Policy News

• The FDA has approved Aduhelm (aducanumab) for the treatment of Alzheimer’s.  Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments.  Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.  Go here to see the FDA announcement and go here for further information about Aduhelm.

Medicare Payment Advisory Commission

• MedPAC has submitted formal comments to CMS on three proposed Medicare payment regulations for FY 2022:
  • For inpatient rehabilitation facilities
  • For skilled nursing facilities
  • For hospice care providers

Patient-Centered Outcomes Research Institute

• PCORI, a non-profit organization created through the Affordable Care Act, is launching a Health Systems Implementation Initiative that it says it hopes will “…provide a channel to facilitate real-world uptake and use of evidence in healthcare delivery systems.”  To this end, PCORI has published a request for information through which it seeks “…to learn about health systems’ interest in undertaking implementation projects to improve care delivery based on findings from PCORI-funded research and related evidence.  Further, PCORI seeks feedback regarding the incentives and support that would enable health systems to undertake these activities.”  See an introduction to the project here and find the RFI here.  Questions are due by June 24 and responses are due by July 15.

Stakeholder Events

Wednesday, June 9 – FDA

Virtual Town Hall Series- Coronavirus (COVID-19) Test Development and Validation
Wednesday, June 9 at 12:15 pm ET  Click here for connection information
FDA will host a virtual town hall for COVID-19 test developers. The purpose of this town hall is to help answer technical questions about the development and validation of tests for COVID-19.

Thursday, June 10 – FEMA
COVID-19 Pandemic Operational Guidance Webinars
Thursday, June 10 at 11:00 am at 12:00 pm  ET Click here for connection information
FEMA is offering a series of webinars throughout the month of June to further educate people on the pandemic operational guidance.  The webinar will cover information included in the COVID-19 Pandemic Operational Guidance: All Hazards Incident Response and Recovery, a document aimed at helping emergency managers plan for disaster response and recovery while adhering to public health guidelines to prevent the spread of COVID-19.

Thursday, June 10 – CMS

Rural Health Open Door Forum

Thursday, June 10 at 2:00 ET

Items on the agenda include the FY 2022 inpatient prospective payment system rule, including graduate medical education policies, and a COVID-19 vaccination payment update.

This call will be by conference call only.  To participate by phone dial 1-888-455-1397 and reference conference passcode 8604468.  Persons participating by phone are not required to RSVP.  TTY Communications Relay Services are available for the hearing impaired.  For TTY services dial 7-1 or 1-800-855-2880 and a relay communications assistant will help.  Instant Replay is available by dialing 1-866-346-7095; no passcode needed.

Friday, June 11 – FDA
Identification of Medicinal Products: Path to Global Implementation
Monday, 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
Monday, 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.