By Arthur Fried and Amy Lerman

Law360 (April 17, 2020, 5:30 PM EDT) --

Arthur Fried

Amy Lerman

As the spread of COVID-19 across the nation and around the world has dramatically limited safe access to health care providers, many U.S. jurisdictions quickly moved to implement a wide array of emergency measures to allow increased access to providers, including through telehealth, in the face of widespread physical distancing orders. This article provides an overview of the types of waivers that have been issued at the federal and state levels, with a specific focus on New York.

Medicare

In early March, amid increasing attention on the growing COVID-19 pandemic[1], Congress passed legislation that provided for more than $8 billion in emergency funding to combat COVID-19. This supplemental funding package included the Telehealth Services During Certain Emergency Periods Act of 2020,[2] which authorized the administration to loosen restrictions on telehealth in order to expand access to COVID-19 related telehealth services for Medicare beneficiaries — many of whom are especially vulnerable to this virus — and in the event of future emergencies.

On March 17, the Trump administration announced the implementation of this waiver with a retroactive effective date of March 6.[3]

Prior to the COVID-19 outbreak, the Medicare program had among the most narrow rules and requirements for payment of telehealth services. Beginning in late 2001, Congress amended the Social Security Act to provide for limited coverage of telehealth services, largely to benefit those beneficiaries living in rural areas.

Coverage of telehealth services was to include: (1) live, synchronous, two-way modalities, where the patient and provider are linked by real-time, audiovisual technology (excluding telephone communications); (2) that were provided to rural-based patients; (3) who received the care at specific types of locations.[4]

Medicare has since broadened its coverage of telehealth services, but in limited ways. Yet, despite these recent expansions, broad use of these services by Medicare beneficiaries is still limited by the narrow geographic and location restrictions that have long existed. To its credit, however, the Medicare program was among the first of payors to eliminate most of its traditional barriers to payment for such services in the wake of the COVID-19 outbreak.

The Telehealth Services During Certain Emergency Periods Act of 2020 Act relaxed some of Medicare's restrictions on coverage of telehealth services as in connection with the COVID-19 public health emergency declaration.[5]

Specifically, the act granted the secretary of the U.S. Department of Health and Human Services authorization to waive or modify the application of Medicare statutory and applicable regulatory provisions for telehealth services delivered by a qualified provider in an emergency area during an emergency period, including any telehealth service that is already reimbursable under applicable HCPCS codes — not just services for the treatment of COVID-19.

In addition, the Telehealth Services During Certain Emergency Periods Act of 2020 Act allowed for the waiver of current restrictions that prohibit the use of a telephone to conduct the telehealth visit,enabling provision of telehealth services beyond a virtual check-in through audio-only telephone.[6]

Through this waiver-based expansion, Medicare is now covering telehealth services provided via telephone as long as the telephone has "audio and video capabilities that are used for two-way, real-time interactive communication."[7] Finally, the act enables Medicare to cover telehealth services to beneficiaries regardless of where they live and where they seek to receive care for the period of the emergency.

The Centers for Medicare & Medicaid Services has subsequently issued additional regulatory waivers giving Medicare providers flexibility during this emergency period, with the goal of expanding treatment capacity. On March 30, CMS issued a press release[8] announcing several of these initiatives, including:

Increased Hospital Capacity

CMS is allowing local ambulatory surgical centers that have cancelled elective surgeries to contract with local health care systems to provide hospital services or to enroll and bill as hospitals.

CMS also is temporarily permitting nonhospital buildings to be used for patient care and quarantine sites; allowing health care entities to perform tests for COVID-19 at people's homes and in other community-based settings; allowing physician-owned hospitals to temporarily increase their number of licensed beds, operating rooms and procedure rooms; and allowing other flexibilities such as ambulance transport and telehealth.

Expansion of Health Care Workforce

CMS is allowing hospitals and health systems to increase workforce capacity during the emergency by temporarily removing barriers for providers to be readily hired from the community and those licensed in other states without violating Medicare rules. CMS also is issuing waivers to let nonphysician practitioners perform services such as ordering tests and medications that may have previously required a physician's order. CMS is allowing providers to enroll temporarily in Medicare to provide care during the crisis.

Prioritizing Patients Over Paperwork

CMS is temporarily eliminating paperwork requirements including covering respiratory-related devices and equipment for any medical reason, eliminating the need for written policies on visitation of patients in COVID-19 isolation, and relaxing audit and reporting requirements.

Promoting Greater Use of Telehealth

CMS is allowing for more than 80 additional services to be furnished via telehealth during the crisis. Medicare providers will be able to evaluate beneficiaries who have audio-only phones and will be able to bill for telehealth visits at the same rate as in-person visits. Beneficiaries will be permitted to stay in their homes during such encounters.

CMS also is temporarily allowing the use of telehealth to fulfill certain face-to-face requirements and has made it clear that remote patient monitoring services may be provided to beneficiaries dealing with acute and chronic conditions. Further, CMS is allowing physicians to supervise other clinical staff virtually when appropriate.

Congress also enacted the Coronavirus Aid, Relief, and Economic Security Act, which further relaxes rules and requirements related to the provision of telehealth services by Medicare (and other payors). Among its numerous provisions, the CARES Act:

• Waives the requirement that practitioners be licensed in the state where they are providing services, so long as the state in which the patient is located permits it;

• Waives numerous face-to-face encounter requirements, such as for home dialysis patients, home health patients and hospice patients;

• Waives the requirement that there be a preexisting patient/provider relationship for telehealth services; and

• Enables and enhances payment for federally qualified health centers and rural health clinics providing telehealth consultations.

CMS continues to release additional guidance for Medicare providers related to the use of telehealth and other modifications to program rules and requirements.[9]

Medicaid

Most rules regulating Medicaid payment for telehealth services are governed by state law. Even before the COVID-19 outbreak, New York state had expanded its coverage of telehealth services. By statute, services covered under health insurance cannot be excluded from coverage when the service is delivered via telehealth, which services will be reimbursed at parity with existing off-site visit payments. New York was also one of the first states to expand telehealth coverage for Medicaid beneficiaries during the COVID-19 emergency, and remains one of the most expansive in terms of Medicaid telehealth coverage.

New York's comprehensive guidance regarding the use of telehealth during the COVID-19 state of emergency, which has also been expanded to include telephonic services, is intended to provide a broad expansion of the ability of all Medicaid providers in all situations to use a wide variety of communication methods to deliver services remotely, as long as the service is appropriate for telehealth.[10]

Among the specific actions taken by New York to further promote telephonic and telehealth services are:

Telephonic Evaluation

Beginning with dates of service of March 1, Medicaid will reimburse telephonic evaluation and management services for established patients where face-to-face visits may not be recommended and it is medically appropriate to evaluate and manage the patient by phone. Additionally, where a patient face-to-face visit is not possible due to the state of emergency, telephonic visits documented as clinically appropriate by the provider will be considered medically necessary for Medicaid payment purposes. Telephonic communication will be covered by Medicaid when provided by any qualified practitioner or service provider.

Face-to-Face Requirements

Home and community-based services provided under both the home health care management and 1915(c) children's waiver are authorized to be provided telephonically or via telehealth whenever possible in lieu of face-to-face contact.

Use of Telehealth

Also for New York Medicaid Managed Care plans, under recent amendments to the New York Insurance and Public Health Laws, services that are covered under a comprehensive health insurance policy or contract must be covered when the service is delivered via telehealth.

The New York State Department of Health is encouraging the use of telehealth modalities to provide COVID-19 related services to Medicaid recipients. For the duration of the emergency there are no limits on the originating sites (place where the patient is located) or the distant site (location of the provider), as long as the latter is within the United States or U.S. territories.

State Licensure Waivers and Modifications

After a number of states took the lead in relaxing various professional practice requirements, the secretary of the U.S. Department of Health and Human Services called on all states to remove licensure and scope of practice barriers during the emergency caused by the coronavirus pandemic, including to cross-state practice. In his March 24 letter and accompanying guidance, HHS Secretary Alex Azar urged state governors, among other things, to temporarily:

• Waive licensure requirements or restrictions to allow health professionals licensed, registered or certified and in good standing with another state to practice in their state, either in person or through telemedicine;

• Waive statutory and regulatory standards to allow the use of telehealth modalities to establish a patient-provider relationship, and diagnose and deliver treatment recommendations;

• Permit the rapid certification/licensure and recertification/relicensure of health care professionals; and

• Rescind medical malpractice insurance provisions that prevent coverage of a health care provider's COVID-19 emergency response in another state and work with health care insurers to waive similar limitations in their policies.

Upon receipt of Azar's letter, many states complied in a number of these areas. Of the 51 U.S. jurisdictions (including Washington, D.C.) only seven have not, to date, enacted some sort of emergency measure allowing health care providers licensed in another state to practice there without a separate license to practice medicine in that state.

Many of those emergency rules apply equally to various types of health care practice through telehealth. New York, for example, is allowing physicians, nurses and physician assistants licensed and in current good standing in any state in the U.S. to practice medicine in New York state.

HIPAA

To further facilitate the delivery of telehealth services, the HHS Office for Civil Rights has issued a notification of enforcement discretion for telehealth remote communications. OCR will exercise its enforcement discretion and will not impose penalties for noncompliance with Health Insurance Portability and Accountability Act in connection with the good faith provision of telehealth during the COVID-19 emergency.[11]

Conclusion

In sum, this unprecedented threat to the public's health has led to an unparalleled easing of regulatory standards that ordinarily operate to protect the public's health, but have had the opposite effect in the face of a highly infectious and deadly disease.

Indeed, many believe that even outside of an emergency situation such as the present one, uniform standards that facilitate greater utilization of telehealth in all geographies and environments, and for all types of providers and payors, will enhance access to quality care. Similarly, greater flexibility to utilize professional licensure in order to provide care across state lines, particularly with respect to telehealth services, could serve to enhance limited access in many areas of the country.

At the same time, providers making the transition from in-person care to telehealth must be mindful of the temporary nature of current changes that are helping to facilitate greater use of telehealth, and should avoid long-range planning around the current rules of the road. All of the various changes are applicable to provision of telehealth services during the COVID-19 pandemic period, and as such are limited in time to this period, however long it may last. It is important for this reason that providers of telehealth services maintain consistent, best practice standards for tasks such as documentation and informed consent. Recommendations for providers include:

• Preserving a record (paper-based or electronic) of fact sheets and other guidances issued by Medicare, Medicaid, commercial payors,and other regulatory agencies (e.g., OIG, the U.S. Drug Enforcement Administration, OCR) — if there is an audit in subsequent years you will want to be able to readily produce these materials as support for decision-making during this time period.

• Documenting adherence to the criteria set forth by Medicare, Medicaid, commercial payors and other regulatory agencies (e.g., OIG, DEA, OCR);

• Documenting requests by patients for telehealth visits, as well as patients' consent to treatment via telehealth; and

• Documenting that patient visits occurred during the COVID-19 pandemic time period.

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Arthur Fried and Amy Lerman are members at Epstein Becker & Green PC.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] See World Health Organization, WHO Director-General's Opening Remarks at the Media Briefing on COVID-19 (Mar. 11, 2020), https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020.

[2] H.R.6074, Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020.

[3] Centers for Medicare & Medicaid Services, Press Release, President Trump Expands Telehealth Benefits for Medicare Beneficiaries During COVID-19 Outbreak (Mar. 17, 2020), https://www.cms.gov/newsroom/press-releases/president-trump-expands-telehealth-benefits-medicare-beneficiaries-during-covid-19-outbreak.

[4] See 42 C.F.R. § 410.78(a)(3), (b) and Sec. 223(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (P.L. 106-554).

[5] U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Determination That a Public Health Emergency Exists (Jan. 31, 2020), https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.

[6] Pursuant to the Act, to be codified as 42 U.S.C. § 1320b-5(b)(8). The virtual check-in limits coverage of telehealth interactions to those with established patients where the communication is not related to a medical visit within the previous seven days and does not lead to a medical visit in the succeeding twenty-four hours. Telehealth interactions that fall out of this duration scope are "bundled" with the other medical visit(s) and the virtual check-in is not coverage as a separately identifiable service.

[7] Pursuant to the Act, to be codified as 42 U.S.C. § 1320b-5(g)(3).

[8] See Centers for Medicare & Medicaid Services, Press Release, Additional Background: Sweeping Regulatory Changes to Help U.S. Healthcare System Address COVID-19 Patient Surge (Mar. 30, 2020), https://www.cms.gov/newsroom/fact-sheets/additional-backgroundsweeping-regulatory-changes-help-us-healthcare-system-address-covid-19-patient.

[9] See Centers for Medicare & Medicaid Services, Current Emergencies, https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page.

[10] New York's Medicaid Program Telehealth Guidance can be found at https://health.ny.gov/health_care/medicaid/program/update/2020/no05_2020-03_covid-19_telehealth.htm.

[11] The Notice of Enforcement Discretion can be found at https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html.

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