The following is the latest health policy news from the federal government as of 2:30 p.m. on Monday, September 13.  Some of the language used below is taken directly from government documents.

Provider Relief Fund

• HHS and its Health Resources and Services Administration (HRSA) are making $25.5 billion in new funding available for health care providers affected by the COVID-19 pandemic.  This funding includes $8.5 billion in American Rescue Plan money for providers that serve rural Medicaid, Children’s Health Insurance Program (CHIP), or Medicare patients and an additional $17 billion for Provider Relief Fund Phase 4 grants for a broad range of providers that can document revenue loss and expenses associated with the pandemic.  To learn more about the funding to be distributed and how it will be distributed, see the following resources:
  • the HHS announcement
  • a more detailed explanation from HRSA
  • information about the calculation of Phase 3 grants

NASH members received a more detailed explanation about the availability of these funds last Friday, September 10.

The White House

• In support of the president’s speech about his administration’s next steps in the fight against COVID-19, the White House has published a plan describing those next steps.  The plan, “Path Out of the Pandemic,” consists of six parts:
  • vaccinating the unvaccinated
  • further protecting the vaccinated
  • keeping schools safely open
  • increasing testing and requiring masking
  • protecting the economy recovery
  • improving care for those with COVID-19
• The White House has posted a transcript of the September 10 press briefing given by its COVID-19 response team and public health officials.  Find the slides presented during the briefing here.

Department of Health and Human Services

COVID-19

• HHS has amended the Public Readiness and Emergency Preparedness (PREP) Act declaration to provide liability protection to licensed pharmacists, pharmacy technicians, and pharmacy interns to provide a pathway for increased access to COVID-19 therapeutics – specifically, monoclonal antibodies – especially in surge states with rising numbers of COVID-19 cases and in rural areas where access to inpatient and outpatient services may be more limited.  For more information about the health care professionals to which these protections have been extended and about the protections themselves, see this HHS announcement.  This amendment of the PREP Act also will be published in the Federal Register; go here to see a pre-publication version of the Federal Register notice.

Health Policy News

• HHS, the departments of Labor and the Treasury, and the Office of Personnel Management have proposed rules that would require health plans, issuers, and providers of air ambulance services to submit detailed data regarding air ambulance services specified in the reporting requirements of the No Surprises Act.  The rules also outline CMS’s authority to fully enforce Title I (the No Surprises Act) and Title II (Transparency) of Division BB of the Consolidated Appropriations Act of 2021 in states that do not have the authority to enforce or fail to substantially enforce one or more of the provisions and seek to help consumers understand the compensation being paid to agents and brokers who help them select health insurance.  This is the latest regulatory action in a series of rulemaking implementing the No Surprises Act.  Learn more from the following resources:
  • an HHS news release
  • an HHS fact sheet about the proposed rule
  • a pre-publication version of the proposed rule itself

• HHS is awarding $20 million in American Rescue Plan grant funding to state-based marketplaces to increase consumer access to affordable, comprehensive health insurance coverage.  The grants will be used by 21 state-based marketplaces to modernize IT systems and/or conduct targeted consumer outreach activities to help make health care coverage enrollment simpler.  Learn more about how the money will be used and which state-based marketplaces will receive it in this HHS announcement.
• HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA) is awarding more than $123 million in funding through six grant programs to provide support to communities and health care providers to help combat the overdose epidemic.  Grants are being awarded through six existing programs:  Medication Assisted Treatment for Prescription Drug and Opioid Addiction; Tribal Opioid Response Grants; Screening, Brief, Intervention, and Referral to Treatment; Strategic Prevention Framework for Prescription Drugs; First Responder-Comprehensive Addiction and Recovery Act Grants; and Providers Clinical Support System – Universities.  Learn more about where the money will go and how it will be spent in this HHS news release.

Centers for Medicare & Medicaid Services

COVID-19

• The administration announced that it will require COVID-19 vaccination of staff in all Medicare- and Medicaid-certified facilities.  CMS, in collaboration with the CDC, announced that emergency regulations requiring vaccinations for nursing home workers will be expanded to include hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, among others, as a condition for participating in the Medicare and Medicaid programs.  Go here to find an explanation of the new policy.

Health Policy News

• CMS announced that it is rescinding audit determinations for providers notified in January of 2021 that they had failed to qualify for what is known as the “mid-build exception.”  The Bipartisan Budget Act of 2015 changed how off-campus provider-based departments are paid for items and services furnished to Medicare beneficiaries.  CMS will review each previously failing provider’s audit findings for compliance with statutory requirements and for accuracy and completeness and providers that received failing audit determinations are no longer required to report or return overpayments based on those determinations.  Each provider will receive a letter rescinding the previous determination.   An updated audit determination letter will be issued following the review of each provider’s audit.  A new overpayment return deadline for self-identified overpayments will be included in that letter should the provider receive a failing audit determination.  Learn more from this CMS announcement.

Centers for Disease Control and Prevention

• The CDC has updated its COVID-19 infection prevention and control recommendations for health care workers and similar guidance to prevent the spread of COVID-19 in nursing homes.
• The CDC has updated its guidance on managing health care workers who have COVID-19 or have been exposed to the virus.
• The CDC has updated its information about its efforts to promote COVID-19 vaccine equity.

Food and Drug Administration

• The FDA has approved an abbreviated new drug application for dexmedetomidine injection USP, 200 mcg/2 mL, indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.  The drug is often used on COVID-19 patients who need ventilators.  See the FDA’s announcement.

Stakeholder Events

 CDC – Evaluating and Supporting Patients Presenting With Fatigue Following COVID-19 – September 30

The CDC will hold a webinar on evaluating and supporting patients who present with fatigue following treatment for COVID-19.  The webinar will be held on Thursday, September 30 at 2:00 p.m. (eastern).  For further information on the subjects the webinar will cover, those who will be participating in the event, and how to join the webinar, go here.

 FDA – Workshop Addressing Response to the Opioid Crisis – October 13

The FDA will hold a workshop entitled “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS)” to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS effort.  The public workshop will be held on October 13 from 1 p.m. to 5 p.m. (eastern) and October 14 from 1 p.m. to 4:00 p.m.  For information about participating in the workshop or submitting comments or materials, see this Federal Register notice.