As health care providers across the country take steps to initiate or increase use of telehealth to provide patient care while complying with “social distancing” or “shelter in place” directives, federal and state governments have taken, and continue to take, numerous steps to facilitate greater use of telehealth during the COVID-19 pandemic. Given the numerous regulatory hurdles that telehealth providers encounter in ordinary circumstances, these steps meaningfully relax the regulatory requirements associated with treating patients via telehealth for purposes of addressing the COVID-19 pandemic.
Federal Telehealth Actions
Numerous steps taken by the federal government include the following:
CMS Telehealth Waiver
Having been empowered by the President and Congress, CMS has acted to loosen a number of requirements with respect to telehealth. Medicare pays for three types of telehealth services: (1) telehealth visits; (2) virtual check-ins; and (3) e-visits. Virtual check-ins and e-visits, which involve established patients, are not limited to rural areas or particular settings (i.e., they are available in the home). However, in ordinary circumstances and with limited exceptions, Medicare telehealth visits are limited to certain rural areas and can only be initiated in certain settings (not including the home, for most types of services).
Due to the COVID-19 pandemic, CMS has temporarily eliminated those restrictions so that Medicare telehealth visits can now occur in all geographic areas in the U.S. and be initiated by patients from any health care facility or from their home. Although this exception is currently limited to existing patients (i.e., those seen in the immediately preceding three (3) years) under the terms of the waiver authorized by Congress, CMS has announced a policy of enforcement discretion and will therefore not conduct audits to determine whether a prior provider-patient relationship existed for claims submitted during the ongoing public health emergency. Further, the existing patient limitation may soon be completely removed for the purpose of the COVID-19 national public health emergency with the expected passage of the CARES Act currently under consideration in Congress. Stay tuned for further updates from Chambliss concerning the CARES Act.
General CMS 1135 Waivers
CMS has issued a number of blanket waivers that impact telehealth, including temporarily waiving the requirement that out-of-state providers be licensed in the state where they are providing services, if licensed in another state (for Medicare and Medicaid purposes), as well as other waivers that can be requested by states, including waivers designed to expedite enrollment of providers with CMS.
HHS OIG Allowance for Reduction or Waivers of Cost-Sharing in Telehealth Context
Ordinarily, providers that routinely reduce or waive patient cost sharing obligations under federal health care programs risk running afoul of federal fraud and abuse laws. However, the HHS Office of the Inspector General (OIG) has issued a policy statement indicating that physicians and other practitioners who reduce or waive cost-sharing obligations (i.e., coinsurance and deductibles) that federal program beneficiaries owe for telehealth services furnished consistent with applicable coverage and payment rules during the timeframe covered by the HHS Secretary’s COVID-19 Declaration (duration uncertain, but likely to extend at least through April) will not be subject to administrative sanctions. Notably, this policy statement does not waive compliance with other laws pertaining to the applicable services, including state laws. Also, health care providers may, but are not required, to waive such cost-sharing obligations.
Enhanced Telehealth Flexibility Under HIPAA
Earlier in the year, the Office for Civil Rights (“OCR”) at HHS issued guidance on HIPAA exceptions that are generally available in situations such as the current COVID-19 pandemic. However, on March 17, 2020, OCR further announced that it would be exercising enforcement discretion for telehealth remote communications during the COVID-19 national public health emergency. Specifically, OCR indicated that, during the national emergency, health care providers may, in the exercise of their professional judgement, use any non-public facing remote communication product for the good faith provision of telehealth services to patients, even though such products may not fully comply with the HIPAA rules. OCR will not impose penalties for the use of such products or any noncompliance with the HIPAA rules that relates to the good faith provision of telehealth services during the COVID-19 national emergency. Such non-public facing products specifically include Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, among others, and OCR has indicated that it will not impose penalties upon providers for failure to sign a business associate agreement with the providers of such non-public facing products in this specific context. However, OCR has encouraged providers to notify patients that these types of products create privacy risks and has indicated that providers should use all available encryption and privacy features when using such products. This announcement should be particularly helpful to providers who have not previously used telehealth to serve their patients but now desire to do so to better protect the health of their patients and staff.
Notably, for providers subject to the federal statutes and regulations regarding the confidentiality of substance use disorder information (42 C.F.R. Part 2), SAMHSA has issued guidance concerning the use of the medical emergency exception during the COVID-19 national emergency in situations in which a provider is not able to obtain a patient’s prior written consent for disclosure of substance use disorder information in connection with telehealth consultations or other treatment situations. The forthcoming CARES Act under consideration in Congress may provide further flexibility with respect to patient consents and otherwise make Part 2 more consistent with HIPAA.
DEA Public Health Emergency Exception for Telehealth
Along with Medicare limitations, one of the significant remaining obstacles to telehealth practice in ordinary circumstances is the federal prohibition, to which there are very limited exceptions, on internet (including telehealth) prescribing of controlled substances when the prescribing practitioner has not conducted at least one in-person medical evaluation of the patient. Due to the HHS Secretary’s public health emergency declaration, the DEA has indicated that one such exception to the prohibition—the public health emergency exception—is now generally in effect while the current public health emergency continues. Specifically, DEA-registered practitioners in all areas of the U.S. may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met:
- 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; and
- The practitioner is acting in accordance with applicable federal and state laws (i.e. practitioners must still comply with all other applicable federal and state requirements related to prescribing).
Tennessee Telehealth Actions
States across the country are also taking action to increase telehealth flexibility during the COVID-19 pandemic. By way of example, Tennessee has taken the following actions, among others:
Executive Order No. 15
Tennessee Gov. Bill Lee recently issued Executive Order No. 15 and also Executive Order No. 20 which, among other critical actions, set forth a number of significant telehealth-related waivers and directives designed to help address the COVID-19 pandemic:
- Waiver of Licensure Requirements –
- The relevant statutory licensing provisions governing almost all health care providers and facilities licensed by the Tennessee Department of Health or its associated boards or agencies (including physicians, nurses, dentists, psychologists, optometrists, and veterinarians, and facilities like hospitals, nursing homes, ASTCs, hospices, ODCs, etc.) are waived at the Commissioner’s discretion to allow out-of-state health care providers to engage in their profession in connection with the medical response to COVID-19. The requisite form for such waiver will be found on the Department of Health’s Health Professional Boards page.
- For health care facility and practitioner licensees and applicants, including health care practitioners desiring to come out of retirement, a number of licensure application and licensure maintenance requirements have been waived to facilitate the availability of health care providers during the COVID-19 pandemic, including waiver of initial license application fees, waiver of application notarization requirements, and waiver of the requirement to submit proof of continuing education, among other requirements.
- Tennessee requirements regarding scope of licensure for telehealth are waived to the extent necessary to allow any health care practitioner licensed by the Tennessee Department of Health or its associated boards or agencies to provide services via telehealth, regardless of the practitioner’s authority to diagnose. Notably, this waiver does not otherwise alter any licensee’s scope of practice or record-keeping obligations.
- Telemedicine Coverage – A number of key telemedicine-related provisions are authorized, including:
- Health insurance plans are to provide coverage for clinically appropriate, medically necessary covered services via telemedicine to all providers regardless of network status or originating site.
- Providers are urged to follow new guidance from CMS regarding equipment and everyday communications technologies that may be used for provision of telemedicine.
- Health insurance plans are further urged not to impose prior authorization requirements on medically necessary treatment related to COVID-19 delivered by in-network providers via telemedicine.
- Also, out of state health care professionals authorized pursuant to the Order to temporarily practice in Tennessee are permitted to engage in telemedicine with respect to Tennessee patients if the scope of practice of their applicable professional licenses would authorize them to diagnose and treat humans.
- Statutory restrictions on telehealth with respect to pain management clinics and chronic nonmalignant pain treatment are suspended.
Commercial, Medicare Advantage, and Tenncare Health Insurance Plans
As reported by the Tennessee Medical Association, major commercial plans in Tennessee are currently providing coverage for telehealth services provided to patients in their homes. The same is reportedly the case for certain Medicare Advantage and all Tenncare plans. The Division of Tenncare has published a letter concerning provision of telehealth under Tenncare during the COVID-19 epidemic, including guidance from each Tenncare plan.
