Medicare Compliance & Reimbursement

See details on the latest COVID-19-related amendment.

The COVID-19 public health emergency (PHE) has upended life as we know it and caused general mayhem for almost a year. So, it should come as no surprise that vaccinating the public — a behemoth undertaking — would hit a few snags. A recent update, however, may alleviate some issues and help to expedite the vaccine rollout.

Update: On Jan. 28, the Department of Health and Human Services (HHS) Acting Secretary Norris Cochran issued a fifth amendment to the COVID-19 PHE declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). This latest amendment authorizes a more diverse variety of qualified healthcare providers “to prescribe, dispense, and administer” U.S. Food and Drug Administration (FDA)-approved COVID-19 vaccines, an HHS release suggests.

Why? The feds updated the list of qualified healthcare professionals to boost vaccination efforts and meet the needs of the public.

“The Biden Administration is broadening use of the PREP Act to expand the vaccination workforce quickly with additional qualified healthcare professionals,” says Cochran in a release. “As vaccine supply is made more widely available over the coming months, having additional vaccinators at the ready will help providers and state health departments meet the demand for vaccines and protect their communities more quickly.”

Who Is ‘Qualified’ to Administer the COVID-19 Shots?

The fifth amendment to the PHE declaration offers clarity on exactly who HHS deems to be a “qualified healthcare professional” able to administer the COVID-19 vaccines to the public.

“This expanded definition of Covered Person is expected to alleviate some of the hurdles to more effective and expedited vaccine administration,” say attorneys Jessica C. Abrahams, Blake A. Angelino, and Jessica Benson Cox with law firm Faegre Drinker Biddle & Reath LLP in online legal analysis. “The extension of PREP Act coverage to relevant individuals will hopefully assist in achieving that goal, but is not likely to be the last amendment to the PREP Act declaration issued by the new administration,” the Faegre Drinker lawyers add.

First, the amendment allows licensed or certified healthcare providers from any state to prescribe, dispense, and administer the COVID-19 vaccine in any other state or U.S. territory.

Second, “any physician, registered nurse, or practical nurse whose license or certification expired within the past five years” can “prescribe, dispense and/or administer COVID-19 vaccines in any state or U.S. territory so long as the license or certification was active and in good standing prior to the date” it expired, according to HHS.

Lastly, all the healthcare providers referenced in the amendment, and who are now able to administer the vaccines, must complete a COVID-19 training program through the Centers for Disease Control and Prevention (CDC). The amendment also “requires an on-site observation period by a currently practicing healthcare professional,” HHS says.

Understand How the Amendment Impacts State Laws

The PREP Act was enacted in December 2005 and gives the HHS Secretary the power to issue declarations that can remove liability for certain entities in situations where their efforts are combatting the emergency. In this case, the feds are trying to increase COVID-19 vaccinations across the country by offering some regulatory relief by lessening provider restrictions.

“Under the PREP Act, qualified providers are immune from liability under federal and state law against claims arising from the manufacture, distribution, administration and/or use of covered medical countermeasures against COVID-19, except for claims involving willful misconduct,” explains attorney Ada (Kozicz) Janocinska with law firm Rivkin Radler LLP in the Rivkin Rounds health blog.

“The PREP Act [also] preempts any state law that would otherwise prohibit a healthcare provider from prescribing, dispensing or administering the COVID-19 vaccine if the individual is considered a ‘qualified person’ under the PREP Act,” Janocinska asserts.

Tip: Just because you are now covered to dispense the shots under this latest amendment, doesn’t mean you can ignore your state’s COVID-19 vaccine administration rules. Many states have additional training on how the vaccine is distributed and administered with explicit protocols that must be followed, even by qualified healthcare providers.

Bottom line: It’s critical to remember that just because the feds have reeled back certain restrictions, many other regulations are still in place. You must ensure you’re remaining compliant, especially if you’re taking advantage of the provisions under these special emergency declarations.

Resource: Read the PREP Act amendment notice published in the Federal Register on Feb. 2 at www.govinfo.gov/content/pkg/FR-2021-02-02/pdf/2021-02174.pdf.