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Secretary Azar used his authority under the Public Health Service Act to declare a public health emergency across the entire United States on January 31, 2020 giving HHS additional emergency powers to respond to the coronavirus.  On March 13, 2020, President Trump declared a national emergency, unlocking additional powers, under section 1135 of the Social Security Act.

In February, the Alliance for Connected Care called on Congress to expand access to telehealth for Medicare beneficiaries in response to the growing public health emergency.  In March, Congress passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, waiving restrictions on telehealth in Medicare fee-for-service to enable more seniors to access care from the safety of their own homes during the public health emergency.

HHS has used these new powers to unleash a number of changes aimed at increasing access to telehealth.  Please find those provisions most relevant to telehealth listed below:

CMS – Medicare Fee-for Service Payment

On Tuesday, March 17, 2020 the Centers for Medicare and Medicaid Services expanded Medicare coverage for telehealth visits, implementing new powers under the coronavirus legislation.  These changes temporarily remove originating site and geographic restrictions from coverage of teleheath under Medicare fee-for-service.  This coverage applies to all Medicare-approved telehealth services.

HHS OIG – Anti-kickback

In response to the public health emergency, leading provider organizations and the Alliance for Connected Care expressed interest in ensuring the ability of providers to waive co-pays or provide some telehealth services at no cost — to encourage more seniors to access needed care.  On March 17, the HHS Office of the Inspector General (OIG) issued a policy statement assuring providers that they could make these changes without a risk of triggering the Federal anti-kickback statute, the civil monetary penalty and exclusion laws related to kickbacks, or the civil monetary penalty law prohibition on inducements to beneficiaries.

DEA – Telemedicine Prescribing of Controlled Substances

For as long as the Secretary’s designation of a public health emergency remains in effect, Drug Enforcement Administration (DEA)-registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met (as defined under Section 802(54)(D):

  • The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice

  • The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system.

  • The practitioner is acting in accordance with applicable Federal and State law.

FDA – Enforcement Policy for Non-Invasive RPM

FDA issued guidance to expand the availability and capability of non-invasive remote monitoring devices (RPM) to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic.  The March 20 policy creates:

  • Flexibility for modifications to FDA-cleared indications, claims or functionality in response to COVID-19 emergency.

  • Flexibility for FDA-cleared hardware or software to increase RPM monitoring availability or capability.

  • Flexibility for clinical decision support software for monitoring related to COVID-19 and co-existing conditions.

HHS Office for Civil Rights (OCR)  – Health Insurance Portability and Accountability Act (HIPAA)

In response to concerns about the rapid expansion of telehealth to those less equipped to handle a telehealth visit, OCR issued a “Notification of Enforcement Discretion” for telehealth remote communications during the public health emergency.  It clarifies the ability of telehealth to be delivered through platforms such as Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, without risk that OCR might seek to raise HIPAA compliance concerns.

CMS – Medicaid

As a companion to the Medicare fee-for-service telehealth guidance above, CMS issued guidance for states seeking to expand telehealth for Medicaid.  This does not create new policy, but reminds states about the flexibility that exists in the Medicaid program.

CMS – Medicare Advantage (MA)

In response to the coronavirus pandemic, CMS outlined flexibility that Medicare Advantage plans have to help prevent the spread of COVID-19.  One emphasis was expanding access to certain telehealth services.  CMS clarified the ability to add telehealth benefits to existing plans as well as flexibility to waive cost-sharing or reduce costs for specific services.

Federal Guidance for Commercial Plans

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