In light of community spread of COVID-19, federal and state regulators continue to take action to promote the expanded use of telehealth to reach patients, though providers should be aware of reimbursement and compliance-related limitations that may remain.  Following initial agency action on March 17 to waive the “originating site” limitations for telehealth services, CMS released on March 31 an Interim Final Rule to expand the scope of services for which Medicare will reimburse qualifying providers for the duration of the public health emergency.

Below we’ve summarized the impact of significant federal and state measures on providers seeking to roll out (or expand) a telehealth modality for reaching patients during the COVID-19 pandemic.

CMS Waived “Originating Site” Limitations for Telehealth Services

On March 17, using its authority under Section 1135 waivers, the Centers for Medicare and Medicaid Services (CMS) waived the requirement that an “originating site” (where the patient is located) be in a rural or health professional shortage area. For claims with dates of service beginning March 6 and for the duration of the public health emergency, providers may receive Medicare reimbursement for eligible telehealth services furnished to beneficiaries in any geographic area, and at any site including the patient’s home. The waiver applies not only to services relating to cases of COVID-19but to all covered telehealth services.

Site of Service Differentials Will Be Reflected in Medicare Reimbursement for Telehealth Services

In the Interim Final Rule, CMS recognizes that in light of the Section 1135 waivers effectively allowing patients to receive services in their homes, and not limited to rural areas, suppliers may incur the same overhead for these services (such as through employing nursing and administrative staff) as if furnished in person. Accordingly, CMS assumes the resource costs of the services should be reflected in payment to practitioners billing for telehealth during the public health emergency and instructs such practitioners to utilize the place of service (POS) code that would have been reported had such services been provided in person.

CMS Waived Certain Health Professional Licensure Requirements for Medicare Reimbursement, and State Regulatory Authorities Are Following Suit

CMS has waived any requirement that a physician or other healthcare professional be licensed in the state “in which they provide services” for purposes of Medicare reimbursement.

Practitioners remain subject to state-level scope of practice laws, licensure requirements, and professional board rules; however, many have already taken action to waive certain licensure restrictions and renewal requirements, temporarily eliminating further barriers to the increased use of telehealth as a modality to deliver care. In some cases, practitioners are required to obtain a specific form or limited license for the provision of care in a state in which they do not hold an unrestricted license, or are otherwise subject to rules such as that the care must be directly related to treating and/or mitigating the spread of COVID-19.

Additional state actions are likely to follow. In a letter dated March 24, HHS Secretary Azar asked all governors to take immediate action to address healthcare workforce shortages in fighting the COVID-19 pandemic. Specific requests include, among others, allowing health professionals to treat patients in the state without an in-state license, waiving in-person requirements for establishing a patient-provider relationship, and allowing physicians to supervise mid-level practitioners via telephone or other remote means.

Practitioners May Provide Telehealth Services to New Medicare Patients Without Risk of Audit

There have been no changes to the types of practitioners who are eligible for Medicare Part B reimbursement for telehealth services. These include physicians, nurse practitioners, physician assistants, clinical psychologists, nurse-midwives, certified registered nurse anesthetists, clinical social workers, and others.

CMS announced on March 17 that it will not audit claims submitted pursuant to the Section 1135 waivers to ensure a practitioner’s compliance with the requirement that a patient receiving telehealth services be an “established patient.” Also, provisions of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) expressly broaden the statutory authority under Section 1135 of the Social Security Act to allow HHS to waive requirements for a prior-existing patient relationship, or restrictions on telephone usage, for the provision of telehealth services by qualified providers.

The Interim Final Rule also removed the “established patient” limitation otherwise applicable for virtual “check-in” visits.  These short check-in services may now be provided, and billed to Medicare, for new patients, provided all other requirements are met.

Medicare Reimbursement Is Available for More Telehealth Services

As announced in the Interim Final Rule, as of March 30, CMS will pay for more than 80 additional services when rendered via telehealth to Medicare beneficiaries during the COVID-19 pandemic.  These services include emergency room visits, discharge visits and home visits, even if the beneficiary’s communications system has only audio (and not video) capabilities when rendered remotely by a qualified practitioner.  Certain practitioners may also monitor patients and supervise clinical staff remotely.

Prescriptions for Controlled Substances May Be Issued Based on a Telehealth Consultation

Before the waivers were issued, prescriptions for controlled substances based on telemedicine visits had to be predicated on prior in-person medical evaluations, subject to certain exceptions under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. One such exception – the declaration of a public health emergency by HHS – was met on January 31 when HHS Secretary Azar declared a public health emergency with regard to COVID-19. On March 16, HHS Secretary Azar, with the concurrence of the Acting Administrator of the Drug Enforcement Administration (DEA), designated that the telemedicine allowance applies to all Schedule II-V controlled substances in all areas of the United States.

During the pandemic, DEA-registered practitioners may issue prescriptions for all Schedule II-V controlled substances to patients for whom prior in-person medical evaluations have not been conducted as long as all of the following certain conditions are met:

  • The prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of the practitioner’s professional practice.
  • The telemedicine communication platform must use a real-time, two-way communication system with both audio and video capabilities.
  • The practitioner must act in accordance with applicable federal and state law.

In addition, while DEA requires that a prescriber hold a DEA registration in every state where the individual prescribes controlled substances, the DEA has announced that for the duration of the COVID-19 pandemic, practitioners will not be required to obtain additional DEA registrations in states where the prescribing occurs if state-level action (or waiver) permits the practitioner to dispense controlled substances in such state(s). Since HHS’ request of states to relax these and other requirements, we have started to see more flexibility at the state level.

Agency Announcements of Enforcement Discretion Allow Additional Flexibility for Telehealth

The HHS Office of Inspector General (OIG) will not enforce cost-sharing obligations during the COVID-19 pandemic.

CMS did not waive otherwise-applicable cost-sharing obligations of Medicare beneficiaries receiving telehealth services. However, on March 17, the OIG announced that it would not bring an enforcement action under the federal Anti-Kickback Statute or Civil Monetary Penalties Law against any practitioner who waives patients’ cost-sharing obligations during the current public health emergency, as further discussed here.

The HHS Office for Civil Rights (OCR) will not enforce certain requirements for communication systems facilitating telehealth services under the Health Insurance Portability and Accountability Act (HIPAA).

OCR has announced that it will not impose penalties for noncompliance with applicable HIPAA requirements for practitioners providing telehealth services in good faith using any non-public facing remote communication product. OCR has also specified that it will not impose penalties against providers for the lack of a business associate agreement (BAA) with video communication vendors for the use of telehealth during the COVID-19 pandemic.

Although there is not presently a risk of enforcement, providers are encouraged to select a telecommunications vendor that will sign a BAA in the ordinary course or can otherwise represent and warrant its compliance with HIPAA. Providers should implement reasonable safeguards, and ensure their technology vendors can do the same, to protect protected health information from unauthorized disclosure, such as utilizing encryption and privacy modes when feasible. Patients should also be made aware of and should consent to, potential risks to the privacy and security of their personal information that are inherent to telehealth.

States Are Taking Further Action to Urge Payors to Cover Telehealth During the Pandemic

States continue to take action, following HHS’ issuance of the Section 1135 waivers, to offer additional flexibility to providers and other healthcare entities seeking reimbursement for telehealth services. The scope of these actions varies, including directives to state-licensed commercial insurers to cover services furnished remotely and express Medicaid waivers of otherwise-limiting telehealth requirements. Providers should be aware of conditions of payment and other requirements still applicable to telehealth coverage.

CARES Act Expands Funding for and Further Promotes Flexibility in Offering Telehealth

The CARES Act contains funding provisions aimed at increasing access to and opportunities to expand telehealth, as well as temporarily removes certain restrictions on the use of telehealth.  Such provisions are discussed in detail here.

While providers should remain aware of conditions of payment and potential legal barriers that remain, increasing federal and state action in this public health emergency is opening doors to telehealth that allow providers to reach patients in a critical time.

If you have any questions about requirements waived and remaining in place for telehealth services during the COVID-19 pandemic, then please contact the authors of this content.