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 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.  

HHS Mandates COVID-19 Testing and Weekly Data Reporting for Nursing Homes

On August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) announced a new Interim Final Rule (IFR) that changes existing infection control regulations for nursing homes and mandates weekly reporting of COVID-19 related data. 

Testing.  CMS states that, in support of national efforts to control the spread of COVID-19, nursing homes will be required to test staff and to offer testing to residents for COVID-19.  The testing of “staff” includes employees, individuals providing services under arrangement and volunteers.  CMS acknowledges that not all residents and staff will consent or be able to be tested for COVID-19.  Regarding these situations, CMS states in the IFR:

“We acknowledge that not all residents and staff will consent to COVID-19 testing. In accordance with the requirements at § 483.10(c)(6),residents have the right to refuse and/or discontinue treatment.  In addition, staff retain the right to refuse COVID-19 testing.  There may also be instances in which facility residents or staff are not able to be tested, such as the presence of anatomical or other medical contraindications. At § 483.80(h)(5), we are requiring that the facility have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refuse or are unable to be tested.  In these instances, we also expect facilities to take steps to maintain the health and safety of its staff and residents who have not been diagnosed with COVID-19 that may include limiting the staff’s access to the facility and cohorting residents [further described in the IFR].”

The frequency of staff testing will be based on the degree of community spread as an indicator that a facility may be at increased risk for COVID-19 transmission.  CMS states that additional guidance on the testing frequency is forthcoming.  The IFR’s testing requirement will be formally implemented through a revision of the LTC facility infection control regulations at § 483.80.

Reporting.  The IFR also requires nursing homes to submit reports of COVID-19 related facility data to the CDC National Healthcare Safety Network (HNSN) not less than weekly.  Noncompliance with the reporting requirement will be cited at a scope of “widespread,” and a severity of “no actual harm with potential for more than minimal harm that is not immediate jeopardy,” and will constitute a level “F” deficiency.  Civil Monetary Penalties (CMPs) will be imposed for each failure to report with a minimum of $1,000 in CMPs for the first time the facility fails to submit a timely report, and an incremental increase of $500 in the CMPs for each subsequent failure.  For example, the first failure to timely report would entail a $1,000 fine and the second failure to timely report would entail a $1,500 fine.

Additional details on the new infection control and reporting regulations are contained in the IFR.  CMS is waiving the normal notice-and-comment process for this Interim Final Rule citing the Administrative Procedure Act section related to Public Health Emergencies.  The IFR will take effect upon its publication in the Federal Register, which had not occurred as of this writing [August 28, 2020].

Can Employers Limit Off-Duty Activities and Travel During the COVID-19 Pandemic?

Written by:  Meredith L. Eason

Most employers have implemented new policies to comply with OSHA’s requirement to provide a safe workplace and to limit the spread of COVID-19.  These new policies typically include enhanced cleaning procedures, facemask and social distancing requirements, and limitations on business travel and in-person meetings.  Many employers wonder whether they can legally take these policies a step further and place restrictions on their employees’ behavior outside the workplace, particularly if they believe the employee is engaging in risky travel or other behavior that may increase their likelihood of contracting the virus.  Unfortunately, as with most questions surrounding this pandemic, the answer is that it depends.

Certain states (California, Colorado, New York, and North Dakota) have laws that prohibit employers from placing any restrictions on employees engaged in lawful activities outside the workplace.  Other states have more narrow laws, such as statutes that protect the off-duty use of tobacco and alcohol or employees’ rights to free speech.  Employers must also consider other federal and state laws that would impact their ability to control their employees’ activities while they are off the clock.  For instance, employers cannot place restrictions that discriminate against certain protected groups under Title VII, that violate the Family and Medical Leave Act, or that limit concerted activity under the National Labor Relations Act.

Employers generally can place restrictions on their employees’ personal travel or other activities engaged in during their leisure time, if the employer has a reasonable belief that the employee presents an increased risk to the workplace and provided that the policy is enforced uniformly across the workforce.  However, even though it is legal, it probably is not recommended.

Most businesses would have trouble monitoring this and enforcing it equally – for instance, people who do not post their whereabouts on social media are less likely to be singled out than those who do.  Further, there could be substantial business interruptions if an employer mandates a quarantine whenever an employee engages in any type of “risky” behavior on his or her own time.  Employers should also consider whether this is necessary given the needs of the business.  Imposing strict requirements that limit employees’ personal lives could result in low morale and bad publicity, and it is probably not necessary if the majority of the workforce can work from home anyway.

A better approach would be to have a return to work policy in place that is strictly and uniformly enforced, which would require any employee showing symptoms to self-quarantine and would require all employees to wear masks and practice social distancing while in the workplace.  Depending on the business, employers may also want to implement a policy that requires employees to notify the employer about any upcoming personal travel, advise them about the risks of such travel, and implement policies for how the employee will be integrated back into the workforce after taking the trip.

Most of these questions are fact-specific and depend on which state law applies, the job duties of the employees, and the needs of the business.  If you have any specific questions about your workforce, please contact a member of Wyatt’s labor and employment team.

CMS Proposes Permanent Expanded Telehealth Benefits

On August 4, 2020, pursuant to Executive Order on Improving Rural and Telehealth Access, the Centers for Medicare & Medicaid Services (CMS) announced proposed permanent changes to extend the availability of certain telehealth services even after the COVID-19 public health emergency ends to give Medicare beneficiaries more convenient ways to access healthcare, particularly in rural areas. CMS proposes adding services to the permanent Medicare telehealth list here and seeks to create a category of Medicare telehealth services available on a temporary basis. CMS is soliciting feedback and public comments on the proposed rule which are due by October 5, 2020.

FAQs on COVID-19 Testing for Long-Term Care Facilities

On August 5, 2020, the Kentucky Cabinet for Health & Family Services (CHFS) answered Frequently Asked Questions relating to surveillance COVID-19 Testing for long-term care facilities.  These FAQs address common questions about testing of staff and residents, such as who should be tested, how often, should staff be tested if not working, etc.  This follows up the previously issued Provider Guidance: Surveillance COVID-19 Testing for Long-Term Care Facilities which recommends testing each staff member (including agency staff, contracted health professionals and others who regularly enter the facility) at least bi-weekly.

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.

CMS Implements New Hospital Procedure Codes for COVID-19-Related Therapeutics

On July 30, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that new procedure codes are being implemented to allow Medicare to identify the use of the therapeutics remdesivir and convalescent plasma for treating hospital in-patients with COVID-19. These codes will be effective August 1, 2020 and are intended to assist tracking and research efforts of the effectiveness of these treatments. Instructions on these new codes are available here.

Revised Medicare Billing Guidance Allows for Reimbursement for COVID-19 Counseling During Testing

On July 30, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) revised its billing guidance to allow for payment to healthcare professionals who counsel patients, at the time of COVID-19 diagnostic testing, about the importance of self-isolating following testing and prior to the onset of symptoms. Providers should discuss with patients the signs and symptoms of COVID-19, the immediate need for isolation (including before test results are available), and the importance of informing their close contacts to separate from the tested individual. The patient should also be informed that if he or she tests positive, the patient will be contacted by the public health department for contact tracing, and that services may be available to aid the patient’s self-isolation. A counseling check list tool and links to additional information are available here.

Legal Professionals Weigh the Long-Term Impact of CMS 1135 Pandemic Waivers

In response to the COVID-19 public health emergency (PHE), the Centers for Medicare & Medicaid Services (CMS) published numerous 1135 blanket waivers (available here) to help counteract the strains and limitations placed on healthcare providers caused by the virus. On July 24, 2020, the American Health Lawyers Association published a detailed article considering the complexities of continued or amended waivers in: (1) the expansion of telehealth services; (2) the three-day hospital stay requirement for skilled nursing facility (SNF) coverage; (3) hospitals’ ability to provide SNF care; (4) hospitals’ ability to provide care at different locations; (5) waivers to certain supervision requirements; (6) delegation of duties in long-term care facilities; (7) patient access to records in long-term care facilities and home health agencies; (8) use of focus surveys in long-term care; and (9) other blanket waivers. Considerations regarding access to care, standards of care, and fraud and abuse risks will be forefront to CMS’s and lawmakers’ approaches as they look at long-term changes.