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February 1, 2021

Health Headlines – February 1, 2021


HHS Expands Categories of Persons Covered Under the PREP Act Who Can Administer COVID-19 Vaccines – On January 28, 2021, HHS issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), expanding the categories of persons able to prescribe, dispense, and administer COVID-19 vaccines under the protections of the PREP Act (the Fifth Amendment).

HHS first issued a Declaration under the PREP Act in March 2020, providing liability immunity for medical countermeasures against COVID-19.  There have since been four amendments to the Declaration, expanding liability immunity for various actions taken by “qualified persons” in furtherance of the COVID-19 countermeasures.  In the Fifth Amendment, HHS now amends Section V of the Declaration to add additional categories of persons covered under the PREP Act as qualified to prescribe, dispense, and administer COVID-19 vaccines.  The Fifth Amendment specifically permits the following:

  • Any healthcare provider who is licensed or certified in a state to prescribe, dispense, and/or administer COVID-19 vaccines in any other state or U.S. territory “so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest . . . .”
  • Any physician, registered nurse, or practical nurse whose license or certification expired within the past five years to 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 went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline, or investigation by a licensing authority or surrendered following an arrest . . . .”

To be covered by the protections of the PREP Act, the Fifth Amendment requires these qualified individuals to complete the CDC’s COVID-19 Vaccine Training and, for healthcare providers who are not currently practicing or whose license or certification is expired, to undergo a period of on-site observation by a currently practicing healthcare professional.  

The language of the Fifth Amendment can be found here.  The press release issued by HHS is available here.

Reporter, Amy L. O’Neill, Sacramento, +1 916 321 4812, aoneill@kslaw.com.

HHS Releases New Frequently Asked Questions Regarding CARES Act Provider Relief Funds – Last week, HHS released nineteen new and modified Frequently Asked Questions (FAQs) regarding payments distributed to providers via the CARES Act Provider Relief Fund.  The FAQs cover a wide range of topics, including sharing funds between subsidiaries, using funds for COVID-19 vaccines, and more.

The new FAQs broadly discuss the following general categories: (1) ownership structures and financial relations; (2) use of funds; (3) sharing funds; (4) reporting on funds; (5) COVID-19 vaccine distribution and administration; (6) Phase 3 General Distribution; and (7) nursing home infection control distribution.  Notably, the FAQs explain that even if all funds are expended to cover unreimbursed healthcare-related expenses attributable to coronavirus, reporting entities are still required to submit lost revenue information.  More specifically, reporting entities are required to submit actual patient care revenue for calendar years 2019 and 2020 in order to inform program integrity and HRSA’s audit strategy.  Additionally, reporting entities that received General and Targeted Distribution payments will submit a consolidated report through the Provider Relief Fund Reporting Portal.  As previously reported here, the Reporting Portal is open for registration but not yet open for reporting.

The FAQs also explain that relief fund payments may be used to support expenses associated with the distribution of a COVID-19 vaccine licensed or authorized by the FDA that have not been reimbursed from other sources or that other sources are not obligated to reimburse.  This may include using funds to purchase additional refrigerators or freezers, personnel costs to provide vaccinations, and transportation costs not otherwise reimbursed.  Furthermore, the costs associated with administering a vaccine to a patient with Medicare Part A coverage, but not Part B, would be considered unreimbursed amounts under the Provider Relief Fund, and payments could be used to cover incurred expenses.

The complete FAQ document is available here.

Reporter, Ahsin Azim, Washington, D.C., +1 202 626 9262, aazim@kslaw.com.

President Biden Orders Special Enrollment Period for Federal Marketplaces and Review of Policies “Inconsistent” with ACA and Medicaid Goals – On January 28, 2021, President Biden signed the “Executive Order on Strengthening Medicaid and the Affordable Care Act” which, among other things, ordered a special enrollment period (SEP) for the federal Health Insurance Marketplace offered by the HealthCare.gov platform.  The Executive Order also directs the Secretary of HHS to review all existing regulations and agency policies to determine whether they are consistent with the stated goal to “protect and strengthen Medicaid and the [Affordable Care Act].”  Finally, the Executive Order revokes two earlier orders invoked by the Trump Administration.

The Executive Order cites “the exceptional circumstances caused by the ongoing COVID-19 pandemic” as the reason for the SEP.  Pursuant to the Executive Order, CMS announced that the SEP will be open beginning February 15, 2021 through May 15, 2021.  The SEP will apply to the 36 states utilizing the federal Marketplace platform.  CMS has encouraged states operating their own health insurance platforms to make a similar enrollment opportunity available to consumers in their states.

The Executive Order also charges the Secretary of HHS to perform an “immediate review” of its current regulations and policies to determine whether those regulations and policies are inconsistent with the goals of Medicaid and the Patient Protection and Affordable Care Act (ACA).  The review pertains to existing regulations, orders, guidance documents, policies, and any other similar agency actions.  Specifically, the following areas are enumerated in the Executive Order for review:

  • policies or practices that may undermine protections for people with pre-existing conditions, including complications related to COVID-19, under the ACA;
  • demonstrations and waivers, as well as demonstration and waiver policies, that may reduce coverage under or otherwise undermine Medicaid or the ACA;
  • policies or practices that may undermine the Health Insurance Marketplace or the individual, small group, or large group markets for health insurance in the United States;
  • policies or practices that may present unnecessary barriers to individuals and families attempting to access Medicaid or ACA coverage, including for mid-year enrollment; and
  • policies or practices that may reduce the affordability of coverage or financial assistance for coverage, including for dependents.

Based on these parameters, the Secretary of HHS is to “consider whether to suspend, revise, or rescind” and publish for notice and comment its proposed rules regarding any suspensions, revisions, or repeals.

Finally, the Executive Order revokes Executive Order 13765 of January 20, 2017 (Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal), and Executive Order 13813 of October 12, 2017 (Promoting Healthcare Choice and Competition Across the United States).

The Executive Order is available here

CMS’s press release regarding the SEP is available here

Reporter Michael L. LaBattaglia, Washington, D.C., +1 202 626 5579, mlabattaglia@kslaw.com.

Also in the News

Biden Administration Delays Rule Regarding Organ Procurement – The final rule titled, “Medicare and Medicaid Programs: Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations; Final Rule,” (OPO Final Rule) (RIN:0938-AU02), which was set to take effect on February 1, 2021, has been delayed until March 30, 2021.  CMS is also providing for an additional 30-day comment period for the OPO Final Rule.  The OPO Final Rule, should it be implemented, would impose tougher quality and transparency requirements for organ procurement organizations that receive payment from Medicare and Medicaid.  The Federal Register publication delaying the effective date and providing for the comment period is available here.  On January 20, 2021, the Biden Administration issued a memo ordering that all rules, guidance, or agency actions which did not take effect prior to noon on January 20, 2021, are to be delayed to provide agency officials with the opportunity for further review of the issues of fact, law, and policy raised by this rules. The Biden Administration memo is available here

GAO Finds That Three Trump-Era Healthcare Rules Violate the Congressional Review Act – The Government Accountability Office (GAO) found that three healthcare rules created during the Trump administration violated the Congressional Review Act.  The Congressional Review Act requires that rules take effect 60 days after publication in the Federal Register, or after Congress receives them, whichever occurs later.  Two of the rules, “Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations” (the Stark Law Final Rule) and “Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” (the Anti-Kickback Statute Final Rule), significantly amend Stark Law and Anti-Kickback Statute regulations, respectively.  The third rule, “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection For Certain Point-of-Sale Reductions in Price On Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees,” (the Medicare Part D Rule) amends the discount safe harbor such that rebates paid from drug manufacturers to Medicare Part D prescription drug plan sponsors or their pharmacy benefit managers are not protected from liability under the discount safe harbor.  Pursuant to the January 20, 2021 Biden Administration memo, the GAO’s findings may permit the Biden Administration to issue new effective dates for these three rules.  The Stark Law Final Rule is available here.  The Anti-Kickback Statute Final Rule is available here. The Medicare Part D Rule is available here.