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.  

Government May Publish Names of Hospitals with Missing Data Reporting

On September 2, 2020, the Wall Street Journal reported that the federal government is planning to publicize the names of hospitals that have not met COVID-19 data reporting requirements as early as next week.  Hospitals are required to submit data daily to the Department of Health and Human Services (HHS) Protect reporting system on testing, capacity and utilization, and patient flows to facilitate the public health response to COVID-19.   

Nursing Homes May Qualify for Performance-Based Provider Relief Funds

As we reported last week, the Department of Health and Human Services (HHS) announced that it was developing “performance indicators” for distribution of an additional $2 billion to nursing homes this fall.  On September 3, 2020, HHS published the metrics for evaluating performance for these performance-based incentive payments.  Qualified nursing homes and skilled nursing facilities that report data through the National Healthcare Safety Network long-term care facility (LTCF) COVID-19 module will be measured against a baseline level of infection in the community where the facility is located.  Against this baseline, facilities will have performance measured on: (1) ability to keep new COVID infection rates low among residents; and (2) ability to keep COVID mortality low among residents. There will be four individual performance periods (September, October, November, and December) each with $500 million available.  Nursing homes will not have to apply to receive a share of this $2 billion incentive payment allocation, but will need to agree to the applicable Terms and Conditions.

Assisted Living Facilities Eligible for COVID-19 Funding

On September 1, 2020, the Department of Health and Human Services (HHS) announced that assisted living facilities may now apply for Provider Relief Fund payments to help address the economic harm and additional expenses caused by the COVID-19 pandemic. Assisted living facilities that may have previously been ineligible for Phase 2 General Funding of the Provider Relief Fund are invited to apply.  Assisted living facilities may receive 2% of their annual revenue from patient care under this funding.  Eligible facilities can apply at the Provider Relief Fund site here until September 13, 2020.

HHS Has Distributed $2.5 Billion to Nursing Homes

On August 27, 2020, the Department of Health and Human Services (HHS) announced it has distributed almost $2.5 billion of an allocated $5 billion from the Provider Relief Fund to nursing homes to support increased testing, staffing, and supply needs to combat COVID-19.  HHS plans to distribute another $2 billion to nursing homes later this fall based on “certain performance indicators” that have yet to be published.  According to HHS data, 208 Kentucky nursing homes have received a total of roughly $41 million from the $2.5 billion distribution.

Pharmacists Authorized by HHS to Administer Vaccines

On August 19, 2020, the Department of Health and Human Services (HHS) announced that it had amended the March 17, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) concerning the COVID-19 Public Health Emergency to increase accessibility of lifesaving childhood vaccines in order to control preventable outbreaks and diseases and mitigate additional strains on the healthcare system. The directive authorizes state-licensed pharmacists to administer, without a doctor’s prescription, vaccines to children ages 3 to 18, pursuant to certain conditions and restrictions. Twenty-eight states already allow pharmacists to administer vaccinations to children. On August 20th, HHS also announced it was expanding the PREP Act’s liability immunity provisions to protect pharmacists and pharmacy interns from liability for alleged harm arising from their administration of vaccines to children.

The amended Declaration can be reviewed here. The American Academy of Pediatrics published an announcement opposing the HHS action, calling it “incredibly misguided” and arguing that pediatricians are the best and safest administrators of childhood vaccinations.

HHS Extends Deadline for Medicaid Providers to Request Relief

In June 2020, Medicaid, Children’s Health Insurance Program (CHIP), and dental providers were able to apply to the Provider Relief Fund for funding of up to 2% of reported revenue from patient care. The initial deadline of July 20, 2020 was extended to August 3. Now, the Department of Health and Human Services has extended the deadline to August 28 to apply for funds. Furthermore, starting next week, Medicare providers who missed the opportunity to apply for additional funding from the initial Medicare General Distribution made in April will be able to apply for funds until August 28.

HHS Office of Inspector General Updates its FAQs on Arrangements During the COVID-19 Public Health Emergency

On July 29, 2020, the Department of Health and Human Services Office of Inspector General (OIG) updated its FAQs published in response to inquiries from the healthcare community on the application of the OIG’s administrative enforcement authorities to arrangements connected to the COVID-19 public health emergency. More specifically, the OIG concluded that if certain conditions are met, there is a low risk of fraud and abuse for an oncology practice to offer free or discounted lodging to patients who are Federal health care program beneficiaries and who, prior to the COVID-19 emergency, would have  qualified for free or discounted housing at a nonprofit lodging facility while receiving chemotherapy or radiation treatment. Applicable conditions include: (1) the patient must reside more than fifty miles from the treatment site; (2) the patient is an established patient of the practice who scheduled the treatment prior to the offering of the free or discounted lodging; (3) the lodging aid would facilitate the patient’s access to care while receiving treatment; (4) the practice reasonably believes that the patient would have qualified for free or discounted lodging during treatment at a nonprofit lodging facility that is closed as a result of the COVID-19 emergency; (5) the aid is in-kind (as opposed to a stipend given directly to the patient); (6) the lodging is in close proximity to the treatment site; (7) the practice does not advertise the availability of this aid; and (8) the lodging is provided during the COVID-19 emergency. Healthcare providers are invited to submit inquiries to OIGComplianceSuggestions@oig.hhs.gov after reading these FAQs.

HHS Renews COVID-19 Public Health Emergency

On July 23, 2020, Secretary of Health and Human Services Alex Azar renewed the determination that a Public Health Emergency related to the COVID-19 pandemic exists. Secretary Azar first declared the COVID-19 Public Health Emergency on January 27, 2020 and first renewed that declaration on April 21. This renewal was due to expire on July 25. The emergency powers granted through a Public Health Emergency have empowered the expansion of telehealth, emergency approval of new drugs and tests, and a host of waivers and flexibilities to facilitate and aid providers’ treatment of their patients through the COVID-19 pandemic. This new expansion will last for 90 days until late October.