HHS Announces Providers Can Use Provider Relief Fund Payments for Vaccine Distribution

On October 28, 2020, the Department of Health and Human Services (HHS) updated the Provider Relief Fund FAQs on Use of Funds to provide that healthcare providers can use payments received from the Provider Relief Fund to pay for equipment, personnel and transportation costs to be used to support distribution of a COVID-19 vaccine licensed or approved by the Food and Drug Administration. However, these funds cannot be used for expenses and losses related to vaccine distribution that have been reimbursed from other sources that are already obligated to reimburse such expenses, including Medicare, Medicaid, and CHIP (Children’s Health Insurance Program). These new FAQs join other recent guidance from HHS regarding which expenses and losses providers can legally count toward the COVID-19 Provider Relief Fund grants.

HHS Authorizes Qualified Pharmacy Technicians and State-Authorized Pharmacy Technicians to Administer Childhood and COVID-19 Vaccines

On October 21, 2020, the Department of Health and Human Services (HHS) announced that it had authorized qualified pharmacy technicians and State-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines (when available), and COVID-19 tests, subject to certain conditions. This guidance expands the HHS September 2020 authorization allowing pharmacists to administer childhood vaccines and COVID-19 vaccines. The requirements applicable to pharmacy technicians and authorized pharmacy interns include, among other things:

  • The vaccination must be ordered by the supervising qualified pharmacist.
  • The supervising qualified pharmacist must be readily and immediately available to the immunizing qualified pharmacy technicians.
  • The vaccine must be FDA-authorized or FDA-licensed.
  • In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendation(s).
  • In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
  • The qualified pharmacy technician or State-authorized pharmacy intern must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include a hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.
  • The qualified pharmacy technician or State-authorized pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.
  • The qualified pharmacy technician must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during the relevant State licensing period(s).
  • The supervising qualified pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary care provider when available and submitting the required immunization information to the State or local immunization information system (vaccine registry).
  • The supervising pharmacist is responsible for complying with requirements related to reporting adverse events.
  • The supervising qualified pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy technician or State-authorized pharmacy intern. 
  • The qualified pharmacy technician and State-authorized pharmacy intern must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients when appropriate.

The supervising qualified pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

HHS Expands Phase 3 Provider Relief Fund Eligibility

On October 22, 2020, the Department of Health and Human Services (HHS) announced that the Phase 3 Provider Relief Fund (PRF) application period has been expanded to include additional provider applicants, including residential treatment facilities, chiropractors, and eye and vision providers who have not yet received PRF distributions. Regardless of whether or not they accept Medicare and Medicaid, providers can apply for Phase 3 PRF distributions here until November 6, 2020.

HHS Updates Provider Relief Fund Distribution Reporting Requirements

On October 22, 2020, the Department of Health and Human Services (HHS) announced that it had updated its final reporting guidance originally published in September. The update includes clarification that, for purposes of relief payment for lost revenues attributable to COVID-19, recipients must submit information showing a negative change in year-over-year net patient care operating income. The updated FAQs on reporting can be found here and the HHS policy memorandum on the reasons for the change can be found here.  

Hospitals Must Ensure that Patients Can Exercise Religious Rights

On October 20, 2020, the Office for Civil Rights (OCR) at the Department of Health and Human Services announced that it had resolved two religious discrimination complaints concerning clergy access to patients during the COVID-19 pandemic. More specifically, complainants alleged that hospitals had denied requests for clergy to have access to hospital patients to administer requested religious services. The Centers for Medicare & Medicaid Services has emphasized that facilities must ensure patients have adequate and lawful access to chaplains or clergy during the COVID-19 pandemic in conformance with the Religious Freedom Restoration Act and Religious Land Use and Institutionalized Persons Act. Acting with OCR, the named hospitals developed revised religious hospital visitation policies to ensure that patients can freely exercise their religious rights while remaining in conformance with hospital safety and care policies and practices necessary to prevent the transmission of COVID-19.

Hospitals Must Report Daily Flu, COVID-19 Data to HHS

On October 6, 2020, the Department of Health and Human Services (HHS) announced that starting October 7, hospitals will have 14 weeks to comply with federal COVID-19 data-reporting requirements.  This timeline follows the interim final rule published on September 2 that requires all Medicare and Medicaid-certified hospitals to provide daily data updates to HHS on numerous COVID-related measures.  Under the new guidance, hospitals will also have to provide similar data about the seasonal flu.  Failure to make the mandatory reporting could result in exclusion from the Medicare and Medicaid programs.

HHS Announces Additional $20 Billion in New Phase 3 Provider Relief Funding

On October 1, 2020, the Department of Health and Human Services (HHS) announced that an additional $20 billion in funding will be available for providers fighting the COVID-19 pandemic.  Providers who have already received Provider Relief Funds may apply, as well as newly-practicing providers and an expanded group of behavioral health providers treating the effects that the pandemic has had on patients’ mental health.  The new funds will include an equitable payment of 2% of annual revenue of patient care for all applicants plus an add-on payment to account for revenue losses and expenses attributable to COVID-19. The application period begins on October 5 and lasts until November 6. Providers are encouraged to apply as soon as possible.

HHS Publishes Reporting Requirements for Provider Relief Fund Recipients and Changes Lost Revenue Calculation

On September 19, 2020, the Department of Health and Human Services (HHS) published new Post-Payment Reporting Requirements applicable to providers who received payments of more than $10,000 from the Provider Relief Fund*.  Qualifying recipients will be required to report: (1) healthcare expenses attributable to the coronavirus not reimbursed by other sources; (2) general and administrative expenses attributable to the coronavirus; (3) lost revenues attributable to the coronavirus; and (4) additional non-financial data.

Notably, HHS has changed how lost revenues must be calculated.  Formerly, HHS provided that “lost revenues” meant any revenue that a health care provider lost due to the coronavirus, such as the difference between a provider’s budgeted revenue and actual revenue, or comparison to revenues for the same period last year.  The new calculation of “lost revenues” defines it as a year-over-year change in net patient care operating income, which is equal to patient care revenue for the year minus patient care related expenses for the year.  The new guidance also places a cap on how much lost revenue providers can claim.

The HHS reporting portal will open on January 15, 2021. *The Post-Payment Reporting Requirements do not apply to Nursing Home Infection Control grants, Rural Health Clinic Testing grants, or reimbursements from the Health Resources and Services Administration Uninsured Program.

HHS to Allow Pharmacists to Order and Administer COVID Vaccines

On September 9, 2020, the Department of Health and Human Services (HHS) announced that it had published guidance authorizing state-licensed pharmacists to order and administer COVID-19 vaccinations to persons age 3 and up, subject to certain requirements.  The authorization preempts any state and local laws that prohibit those who satisfy the HHS requirements from ordering or administering COVID-19 vaccines. These requirements include, among other things:

  • The vaccine must be U.S. Food and Drug Administration (FDA)-authorized or licensed.
  • The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP) COVID-19 vaccine recommendation.
  • The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
  • The licensed pharmacist must have a current certificate in basic CPR.
  • The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each state licensing period.
  • The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including reviewing the vaccine registry or other vaccination records prior to administering a vaccine.
  • The licensed pharmacist must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.
  • The licensed pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

HHS OIG Will Audit Medicare Payments for COVID-19 Patient Discharges

As we previously reported, the Centers for Medicare & Medicaid Services (CMS) recently published new guidance requiring hospitals to document a positive COVID-19 laboratory test to receive a 20% increase in the Medicare Severity-Diagnosis Related Group (MS-DRG) weighting factor for their inpatients being treated for COVID-19. The Department of Health and Human Services Office of Inspector General (HHS OIG) has now updated its work plan providing that it will audit Medicare payments for inpatient discharges billed by hospitals for COVID-19 patients for compliance with Federal requirements, including the positive COVID-19 laboratory test requirement. Hospitals should maintain comprehensive clinical and financial documentation to support their actions and billing practices and avoid potential recoupments from audits in the future.