Alex Azar, Secretary of the U.S. Department of Health and Human Services (“HHS”), declared a public health emergency related to the coronavirus pandemic (“Emergency Declaration”) on January 31, 2020. The Emergency Declaration paved the way for additional actions by various federal and state authorities, including the Centers for Medicare & Medicaid Services (“CMS”), the Office of Inspector General (“OIG”), the Drug Enforcement Administration (“DEA”), and state executives and agencies, to facilitate the delivery of health care services to larger numbers of patients by temporarily waiving certain regulatory prerequisites to the provision of and payment for health care. These authorities are now issuing or seeking relief from a variety of requirements that typically have limited providers’ use of telehealth technologies—including requirements about what equipment may be used for a telehealth visit and where patients may be located when they receive health care through virtual technologies.    

Expanded Access to Care for Medicare Patients.  Due to the Emergency Declaration, on March 13 Secretary Azar authorized waivers and modifications under Section 1135 of the Social Security Act to be effective as of March 1, 2020. CMS, in turn, issued a number of blanket waivers intended to prevent gaps in access to care for Medicare beneficiaries impacted by the coronavirus emergency. CMS also issued a Section 1135 waiver specific to telehealth [1],  including the following key points:  

• Medicare patients can receive telehealth visits at home.  Medicare beneficiaries, who generally are at a higher risk for COVID-19, are now able to visit with their physicians from home instead of potentially heightening their risk—and the risk to others—of contracting the virus by going to a crowded physician’s office or a hospital. Effective as of March 6 and until the public health emergency ends, Medicare will pay for office, hospital, and other visits furnished through telehealth technologies, and patients may participate in these visits from their residences. Providers may furnish telehealth visits, virtual check-ins, and e-visits to Medicare beneficiaries through these technologies. 
• Smart phones may be used for telehealth visits. The telehealth visits may be conducted through computers or phones that have interactive audio and video capabilities, but virtual check-ins and e-visits may be performed through audio-only calls, text messages, or other online interactions.
• No prior physician/patient relationship is required.  CMS recognizes that patients should avoid travel during the emergency, whenever possible, so where it otherwise would be required that the patient have a prior established relationship with a particular practitioner, HHS will not conduct audits during the duration of the emergency to ensure that such a prior relationship existed.   

Waiver of Co-insurance Permitted.  The blanket waivers also allowed OIG to permit providers to waive co-pays and deductibles for Medicare and Medicaid telehealth visits for the duration of the public health emergency [2]. Under normal circumstances, routine waivers of these amounts would implicate the Anti-Kickback Statute and the civil monetary penalty laws. 

FaceTime and Skype May be Used for Telehealth.  HHS’s Office for Civil Rights (“OCR”) announced that it will not impose penalties against providers for violations of certain HIPAA rules when delivering care by telehealth [3]. Specifically, providers who serve patients in good faith using everyday communications technologies like FaceTime or Skype will not be subject to HIPAA enforcement. However, OCR cautioned that this flexibility does not extend to the use of public-facing video communication applications like FaceBook Live and TikTok. Although OCR recommended that providers identify HIPAA-compliant telehealth vendors and enter into business associate agreements (“BAAs”) with such vendors, it will not impose penalties for failure to have a BAA in place or other noncompliance with HIPAA requirements during the emergency. 

Prescribers May Issue Controlled Substance Prescriptions for New Patient by Telehealth.  DEA also has offered flexibility in prescribing for patients in conjunction with telehealth visits. Due to the public health emergency, DEA-registered clinicians may issue prescriptions for controlled substances to patients with whom they have not previously conducted an in-person medical evaluation using an audio-visual, real-time, two-way interactive communication system [4]. This is a significant change, as the Ryan Haight Act generally prohibits clinicians from prescribing controlled substances to individuals they have not examined in person.

States May Seek Additional Waivers.  CMS’s blanket waivers further enabled states to seek their own telehealth-related Section 1135 waivers, which may include temporary waivers of the requirement that physicians and other health care professionals be licensed in the state in which they are providing services (which, for purposes of telemedicine, is the state in which the patient is located), so long as they are currently licensed in another state [5]. These waivers could apply for services provided to all patients, regardless of their health insurer.

State executives, Medicaid agencies, and licensing boards are now seeking or issuing waivers of regulations to assist health care providers in serving individuals during the emergency, including through increased use of telehealth. Examples of such relief include:

• The South Carolina Board of Medical Examiners (“SC Board”) issued an order on March 14 waiving South Carolina licensing requirements for physicians, physician assistants, and respiratory care practitioners who are licensed in good standing in another state and “whose services are determined to be necessary by South Carolina DHEC.”[6] The SC Board has indicated that this means South Carolina will permit these categories of out-of-state practitioners to treat South Carolina residents, in person or through telehealth technologies, to screen or treat patients for the coronavirus.  It is possible that the scope of permitted treatment by these practitioners may expand during the course of the coronavirus emergency.
• On March 19, the South Carolina Department of Health and Human Services (“SC DHHS”) expanded coverage for telephonic and telehealth services for Medicaid enrollees for dates of service on or after March 15, 2020. Claims for these services may be submitted beginning April 1, 2020. The services must be rendered by a physician, nurse practitioner, or physician assistant and are payable only when provided to an established patient. [7] SC DHHS has issued additional policy changes permitting Medicaid coverage of COVID-19 testing, waiving patient cost share for all evaluation and management codes, allowing pharmacies to bypass early refill denials for fee-for-service beneficiaries, suspending the annual ambulatory care visit limit, and waiving the direct supervision requirement for care provided in infusion centers.[8]   
• The North Carolina Medical Board (NC Board) permits physicians who do not hold a license to practice in the state of North Carolina to do so if the Governor has declared a disaster or state of emergency.[9] Governor Roy Cooper issued an Executive Order on March 10 in which he temporarily waived North Carolina’s licensure requirements for health care and behavioral health care personnel who are licensed in another state or territory but wish to provide health care services to individuals in North Carolina.[10] The NC Board permits non-licensees in these circumstances to provide services to patients remotely using telehealth technologies.[11] Following the Executive Order, to assist in meeting the anticipated need for additional health care providers during the emergency, the NC Board voted to permit recently (within the last 24 months) retired or inactive physicians and physician assistants to obtain a temporary license to return to practice upon application and meeting certain circumstances.[12]  
• In Florida, the Surgeon General issued an Emergency Order [13]  on March 16 providing that physicians, physician assistants, and advanced registered nurse practitioners who hold an unrestricted license in another state are permitted to furnish telehealth services to individuals in Florida for a period of 30 days. The Emergency Order also permits licensed physicians, physician assistants, and advanced registered nurse practitioners who have designated themselves as a “controlled substance prescribing practitioner” in accordance with Florida law to issue a renewal prescription for certain controlled substances through the use of a telehealth examination solely to an existing patient to treat chronic malignant pain.

Additional Guidance Likely.  In this time of significant uncertainty, the federal and state governments and enforcement authorities appear to be working collaboratively to assure that patients who need medical attention during the coronavirus emergency are able to get it, in many cases through the use of telehealth applications. These efforts should both help decrease the risk of further transmission of COVID-19 and allow hospitals to focus on treating those patients most in need of intensive and emergency care. As additional waivers and announcements addressing these issues are emerging almost daily, health care providers should remain aware of state and local requirements applicable to specific types of providers and health care services and continue to provide health care services in good faith to patients requiring them.    

[1] Medicare Telemedicine Health Care Provider Fact Sheet (Mar. 17, 2020), available at https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet. 
[2] See OIG Policy Statement Regarding COVID-19 Outbreak (Mar. 17, 2020), available at https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/policy-telehealth-2020.pdf 
[3] See Notification of Enforcement Discretion for Telehealth Remote Communications During the OVID-19 Nationwide Public Health Emergency (Mar. 17, 2020), available at https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html 
[4] See DEA Diversion Control Division, COVID-19 Information Page, available at https://www.deadiversion.usdoj.gov/coronavirus.html 
[5] See COVID-19 Emergency Declaration Health Care Providers Fact Sheet (Mar. 13, 2020), available at https://www.cms.gov/files/document/covid19-emergency-declaration-health-care-providers-fact-sheet.pdf. 
[6] South Carolina Department of Labor, Licensing and Regulation, Board of Medical Examiners, Order Waiving Licensing Requirements for Certain Providers (Mar. 14, 2020), available at https://llr.sc.gov/med/pdf/MedicalBoardOrder3-14-2020Signed.pdf 
[7] See Coronavirus Disease 2019 (COVID-19) Temporary Telephonic and Telehealth Services Updates (Mar. 19, 2020), available at https://www.scdhhs.gov/press-release/coronavirus-disease-2019-covid-19-temporary-telephonic-and-telehealth-services-updates 
[8] See Coronavirus Disease 2019 (COVID-19) Temporary Policy Updates (Mar. 17, 2020), available at https://www.scdhhs.gov/press-release/coronavirus-disease-2019-covid-19-temporary-policy-updates 
[9] Physicians can begin practicing under this rule in one of two ways: (1) under certain defined circumstances, a physician holding an unrestricted license to practice in another state may practice medicine at a North Carolina hospital, or (2) a physician holding an unrestricted license to practice in another state may apply for a limited emergency license to practice medicine in North Carolina under certain conditions. See 21 N.C.A.C. 32B .1706, available at https://www.ncmedboard.org/images/uploads/article_images/Physician-21_ncac_32b_.1706.pdf. 
[10] See State of North Carolina, Executive Order No. 116 (Mar. 10, 2020), available at https://files.nc.gov/governor/documents/files/EO116-SOE-COVID-19.pdf 
[11] See Use of Telemedicine amid COVID-19 Concerns, available at https://www.ncmedboard.org/resources-information/professional-resources/publications/forum-newsletter/notice/use-of-telemedicine-amid-covid-19-concerns 
[12] NCMB Approves Path for Retirees to Help with COVID-19 (Mar. 11, 2020), available at https://www.ncmedboard.org/resources-information/professional-resources/publications/forum-newsletter/notice/ncmb-approves-path-for-retirees-to-help-with-covid-19 
[13] State of Florida, Department of Health, Emergency Order (Mar. 16, 2020), available at http://www.flhealthsource.gov/pdf/emergencyorder-20-002.pdf