340B and Telehealth/HHS Waivers

17 Mar 2020

The COVID-19 pandemic has created an increased need for the use of telehealth services.  Powers has received several questions from Ryan White clinics about whether a prescription for a patient who receives services through telehealth qualifies to be filled with 340B drugs.  A prescription that is written as the result of a telehealth visit may be filled with 340B drugs, provided that the three prongs of the patient definition are met:

  1. the prescriber must be employed by or under contract with the Ryan White clinic, or have received a referral from the Ryan White clinic;
  2. the Ryan White clinic must have medical records of the telehealth visit; and
  3. the service provided via telehealth must be within the scope of the Ryan White clinic’s grant.

For a telehealth visit with a prescriber who received a referral from a Ryan White clinic, the Ryan White clinic is responsible for maintaining documentation of both the referral and the telehealth visit.  We have confirmed with Apexus that the prescriber does not have to be physically located in the Ryan White clinic when providing the telehealth service in order for the prescription to qualify for 340B, as long as the three prongs are satisfied.   In some cases if a patient relationship has already been established, renewals of prescriptions may not require any visit.

HHS announced today a waiver of certain restrictions related to Medicare payment for telehealth services.  Significantly, the waiver allows for Medicare payment for services provided in all settings, including when the patient is at home.  This waiver applies to all patients – not just those with COVID-19.  FAQs on the waiver are available here.

HHS also announced that the Office of Civil Rights would not impose penalties for noncompliance with HIPPA rules in connection with the good faith provision of telehealth during the COVID-19 public emergency.  The announcement is available here.  Powers will be sending a longer client alert on the HHS waivers.

Powers has drafted a  summary and analysis of the Administration’s guidance on the expansion of Medicare coverage of telehealth services and the types of audio/video devices that HIPAA covered health care providers can use to provide telehealth services to patients.  The memorandum is available on  Powers’ website.  Please contact us if you have any questions.

Category: Congress

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