March 20, 2020
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 , including the following key points:
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 . 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 . 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 . 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 . 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:
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.
 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.
 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
 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
 See DEA Diversion Control Division, COVID-19 Information Page, available at https://www.deadiversion.usdoj.gov/coronavirus.html
 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.
 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
 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
 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
 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.
 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
 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
 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
 State of Florida, Department of Health, Emergency Order (Mar. 16, 2020), available at http://www.flhealthsource.gov/pdf/emergencyorder-20-002.pdf
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