|Footnotes for this article are available at the end of this page.
In response to the COVID-19 pandemic, the Centers for Medicare and Medicaid Services (CMS) has issued numerous telehealth waivers and flexibilities aimed at alleviating burdens for health care providers and facilitating the provision of patient care. Most of these waivers and flexibilities are time-limited to the declared public health emergency (PHE) and/or the declared national emergency. In the absence of other administrative action, such waivers and flexibilities that providers have relied upon for the expansion of telehealth during the COVID-19 emergency will end when these declarations expire or are terminated.
The current PHE declaration is set to expire on July 25, 2020. Notably, the U.S. Department of Health and Human Services (HHS) has signaled that Secretary Azar is likely to renew the PHE declaration, which would extend the waivers for another 90 days. In addition, CMS has indicated that it will work to extend permanently certain telehealth flexibilities that are within its general rule-making authority, and it is anticipated that some may be included in the CY 2021 Medicare Physician Fee Schedule Proposed Rule likely to be released this month. However, such rulemaking can be a multi-month process, and there is no allowance under the current framework for a phased approach to termination of the COVID-19 flexibilities. In other words, as soon as the PHE ends, so do the waivers.
Thus, providers should be monitoring for extensions while also preparing for terminations. The expansion of telehealth has seen relaxation of requirements in many areas (e.g., beneficiary location, permitted telehealth technology, practitioner licensure, etc.). In many cases, providers have rapidly implemented new or expanded telehealth programs, based on these flexibilities. When the PHE ends, providers need to understand which elements of their programs will need to be adjusted–either to return to pre-PHE standards or to align with any new changes that are implemented in the interim—and be prepared to implement these adjustments.
Below are a few key areas providers should consider:
Who Is Eligible to Provide Telehealth Services?
Eligible Provider Types: Under pre-PHE rules, telehealth-eligible providers were limited to physicians and certain non-physician practitioners, such as physician assistants, nurse practitioners, and clinical social workers.1 However, pursuant to waiver authority granted under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), CMS has expanded the types of health care professionals that can furnish distant site telehealth services to include all those that are eligible to bill Medicare for their professional services, including physical therapists, occupational therapists, speech language pathologists, and others. Post-PHE, the list of eligible providers will once again revert to the more limited list. Changes to this list will require Congressional action.
Licensure: Generally, Medicare requires that out-of-state practitioners be licensed in the state where they are providing services, i.e., the state where the patient is located. However, during the PHE, CMS is temporarily waiving such requirements pursuant to Social Security Act § 1135(b)(2) when a practitioner is licensed in another state (subject to a few minimum requirements).2 Note that this does not have the effect of waiving state or local licensure requirements, so practitioners must cross check with any other applicable regulatory bodies to confirm that their license will satisfy the requirements of the jurisdiction in which they will be providing services. After the PHE ends, standard licensure requirements will again apply.
What Services Are Reimbursable?
Professional Fees: During the PHE, CMS has expanded the list of Medicare-reimbursable telehealth services.3 This expansion is tied to the duration of the PHE, so providers should be mindful of the services that are eligible for reimbursement once the declaration expires or is terminated. Addition of services to the list is within CMS’s regular rule-making authority, so providers should watch for potential updates making these changes permanent in future rule notices.
Originating Site Fee: CMS clarified that, for the duration of the PHE, when a patient is receiving a professional service via telehealth in a temporary expansion location that is considered a hospital provider-based department – including the patient’s home – and the patient is a registered outpatient of the hospital, the hospital in which the patient is registered may bill the originating site facility fee for the service. Per statute, no originating site fee typically is paid when the originating site is the patient’s home.4 Thus, Congressional action would be required to modify this requirement after the PHE ends. (For more information, see our prior article, here.)
What Technology May Be Used?
“Phones” and Audio-Only: Medicare telehealth services generally must be provided via two-way interactive audio and video telecommunications that permit real-time communication between the distant site physician or practitioner and the Medicare beneficiary.5 However, during the PHE, CMS has issued several waivers that will allow for payment for certain audio-only visits, and also clarified that mobile computing devices that include audio and video real-time interactive capabilities and are colloquially called “phones” satisfy the technology requirement.6 Note, however, that unless provided otherwise, other services included on the Medicare telehealth services list must be furnished using, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.7 Post-PHE, the stricter requirements will again apply.
HIPAA Considerations: Early on in the series of flexibilities announced for telehealth during the PHE, the HHS Office for Civil Rights (OCR) announced that it will exercise enforcement discretion and waive penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies during the PHE.8 Such applications historically have not always been willing or able to satisfy the HIPAA requirements, and accordingly, the conventional guidance has been that such platforms are not acceptable methods to transmit PHI, for example during a telehealth encounter. However, OCR has said that a covered health care provider that wants to use audio or video communication technology to provide telehealth to patients during the PHE can use any non-public-facing remote communication product that is available to communicate with patients, specifically including FaceTime, Skype, and Zoom in its list of illustrative examples.9 Providers should note that such enforcement discretion is slated to end when the PHE expires and should be prepared to discontinue use of such platforms or demonstrate full HIPAA compliance at that time. (For more information, see our prior articles here and here.)
Where Can Patients Receive Telehealth?
A significant limitation to pre-PHE telehealth was the requirement that beneficiaries must be located in certain qualifying “originating sites” in an eligible geographic area (which generally must be rural).10 As defined by statute, these originating sites were largely healthcare facilities (e.g., hospitals, skilled nursing facilities), and only in very limited circumstances was a patient’s home eligible.11 However, under a waiver issued for the duration of the PHE pursuant to the Coronavirus Preparedness and Response Supplemental Appropriations Act,12 CMS has waived the geographic location element, and Medicare will pay for telehealth services provided to beneficiaries wherever they are located.13 This is another example of a flexibility that would require Congressional action to become permanent.
Who Is Eligible to Receive Services by Telehealth?
Generally, any Medicare-enrolled beneficiary is eligible to receive medically necessary telehealth services, though an established relationship with the practitioner may be required prior to such service. However, during the PHE, CMS has said it will not enforce a requirement that patients have an established relationship with the practitioner providing telehealth.14 After the PHE, providers should once again be mindful of whether such established relationship requirements apply to a given encounter.
What Does It Cost Beneficiaries?
Medicare coinsurance and deductibles would generally apply to telehealth services. However, the HHS Office of Inspector General is providing flexibility for healthcare providers to reduce or waive cost-sharing for telehealth visits paid by federal healthcare programs during the PHE.15 After the PHE, providers will once again be responsible for collecting any such cost-sharing amounts. To the extent providers rely on this waiver during the PHE, they should also consider how they communicate this temporary policy to their patients and work to set expectations for the reversion when the PHE ends.
The immediate reversion to pre-PHE requirements may catch some providers off-guard when it occurs. Providers should be prepared to comply with the rules and requirements in effect upon expiration of the PHE—i.e., the pre-PHE rules and any changes to those rules that, through administrative action, survive the PHE—as soon as the PHE expires. Failure to do so could result in issues such as providing services that are no longer eligible to be reimbursed under Medicare, or more seriously, being reimbursed for services that were not provided in accordance with Medicare requirements (e.g., by an inappropriately licensed practitioner), or resulting in violations of other laws (e.g., HIPAA, beneficiary inducement statute). All of these raise thorny legal and compliance issues that providers should proactively endeavor to avoid—including potential overpayment obligations or False Claims Act liability. In various public teleconferences, CMS and OCR have acknowledged this difficulty and have signaled that there may be some informal enforcement discretion exercised as providers pivot when the PHE ends, but such grace period, if any, is likely to be limited in duration and in scope. For more information, please contact Madison M. Pool.
 Social Security Act § 1834(m)(4)(E).
 Centers for Medicare and Medicaid Services, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf (last visited 7/18/20); specifically, CMS will waive the physician or non-physician practitioner licensing requirements when the following four conditions are met: 1) must be enrolled as such in the Medicare program; 2) must possess a valid license to practice in the state, which relates to his or her Medicare enrollment; 3) is furnishing services – whether in person or via telehealth – in a state in which the emergency is occurring in order to contribute to relief efforts in his or her professional capacity; and, 4) is not affirmatively excluded from practice in the state or any other state that is part of the 1135 emergency area.
 See CMS.gov, List of Telehealth Services, https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes (last visited 7/18/20).
 Social Security Act § 1834(m)(2).
 Id. at § 1834(m) & 42 C.F.R. § 410.78; see also, Centers for Medicare and Medicaid Services, Medicare Telemedicine Health Care Provider Fact Sheet, https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet (last visited 7/18/20).
 Centers for Medicare and Medicaid Services, COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers, https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf (last visited 7/18/20); see also, Centers for Medicare and Medicaid Services, Medicare Telehealth Frequently Asked Questions, https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf (last visited 7/18/20).
 See HHS Office for Civil Rights, Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency, https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html (last visited 7/18/20).
 Social Security Act § 1834(m)(4); see also, CMS Medicare Claims Processing Manual, Chapter 12 – Physicians/Nonphysician Practitioners, § 190.2 [HEREINAFTER “Claims Processing Manual”].
 Social Security Act § 1834(m)(4); see also, Claims Processing Manual § 190.1.
 Coronavirus Preparedness and Response Supplemental Appropriations Act, PUBLIC LAW 116–123—MAR. 6, 2020, available at https://www.congress.gov/116/plaws/publ123/PLAW-116publ123.pdf (last visited 7/18/20).
 See Centers for Medicare and Medicaid Services, Medicare Telemedicine Health Care Provider Fact Sheet, https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet (last visited 7/18/20); see also, Centers for Medicare and Medicaid Services, Medicare Telehealth Frequently Asked Questions, https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf (last visited 7/18/20).
 Centers for Medicare and Medicaid Services, Medicare Telehealth Frequently Asked Questions, https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf (last visited 7/18/20).
 Centers for Medicare and Medicaid Services, Medicare Telemedicine Health Care Provider Fact Sheet, https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet (last visited 7/18/20).