In recognition of “the unique circumstances resulting from the COVID-19 outbreak,” the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (“HHS”) announced that the agency will not impose sanctions on certain conduct during the COVID-19 public health emergency that otherwise violates the Stark Physician Self-Referral Law (the “Stark Law”), the Anti-Kickback Statute, and the Civil Monetary Penalty Law’s Beneficiary Inducement Prohibition.
In the first statement issued on March 17, 2020 (“Telehealth Services Policy Statement”), the OIG stated that the agency will not impose administrative sanctions on physicians and other practitioners for reducing or waiving any cost-sharing obligations that Federal health care program beneficiaries may owe for telehealth services.
Ordinarily, routine reductions or waivers of beneficiary cost-sharing amounts (such as coinsurance and deductibles) would implicate the federal Anti-Kickback Statute, the Civil Monetary Penalty and Exclusion Law related to kickbacks, and the Civil Monetary Penalty Law’s prohibition on inducements to beneficiaries.
In order to fall within the exemption under the Telehealth Services Policy Statement, the telehealth services must be furnished consistent with the then-applicable coverage and payment rules and be furnished during the public health emergency. In addition, during the public health emergency, the OIG stated that the agency will not view the provision of free telehealth services furnished alone to be an inducement or as likely to influence future referrals, and will not view the furnishing of subsequent services occurring as a result of the free telehealth services, without more, as evidence of an inducement.
Subsequent to issuance of the Telehealth Services Policy Statement, the OIG clarified in a supplemental FAQ that the policy is not limited to the services defined by Medicare or the Centers for Medicare or Medicaid Services (“CMS”) as “telehealth visits.”[ii] Instead, the OIG intends for the policy to apply to a broad category of non-face-to-face services furnished through various modalities, including telehealth visits, virtual check-in services, e-visits, monthly remote care management, and monthly remote patient monitoring.[iii]
In addition, the OIG clarified in the FAQ that the Telehealth Services Policy Statement applies to both a physician or other practitioner billing for telehealth services or a hospital or other eligible individual or entity billing on behalf of the physician or practitioner for such services when the physician or other practitioner has reassigned his or her right to receive payments to such individual or entity.[iv]
In a second statement issued on April 3, 2020 (“Stark Law Policy Statement”), the OIG stated that the agency will exercise its enforcement discretion not to impose administrative sanctions under the federal Anti-Kickback Statute for certain Stark Law violations that had been waived by HHS during the public health emergency.[v]
Ordinarily, some physician financial relationships that implicate the Stark Law also may implicate, and potentially violate, the Anti-Kickback Statute. However, pursuant to Section 1135 of the Social Security Act, HHS issued Blanket Waivers on March 30, 2020 to ensure that health care providers that furnish services in good faith, but are unable to comply with one or more of the specified requirements of the Stark Law as a result of the consequences of the COVID-19 pandemic may be reimbursed for services and exempted from sanctions for such noncompliance, absent the Government’s determination of fraud or abuse.[vi]
Applicable to conduct occurring on or after April 3, 2020, and continuing until the Blanket Waivers expire, the OIG’s Stark Law Policy Statement adopts all of the conditions and definitions that apply to the Blanket Waivers. Accordingly, the Stark Law Policy Statement applies only to financial relationships and referrals that are related to the COVID-19 public health emergency, i.e., diagnosis or medically necessary treatment of COVID-19 for any patient or individual, whether or not the patient or individual is diagnosed with a confirmed case of COVID- 19, expanding the capacity of health care providers to address patient and community needs due to the COVID-19 outbreak, and shifting the diagnosis and care of patients to appropriate alternative settings due to COVID-19.
Notably, financial arrangements that implicate the Anti-Kickback Statute but do not present violations of the Stark Law (and therefore are not covered by Blanket Waivers) would not be protected by the Stark Law Policy Statement. For example, the OIG stated that the exemption would not apply to direct financial relationships between pharmaceutical or device manufacturers and physicians or between providers where there is no physician involved.
For arrangements directly connected to the public health emergency, the OIG has established a special procedure to accept questions from the health care community regarding the application of the agency’s administrative enforcement authorities and to post answers as Frequently Asked Questions.[vii]
If you have questions about whether particular arrangements or conduct implicates the Stark Law, the Anti-Kickback Statute, or the Civil Monetary Penalty Law’s Beneficiary Inducement Prohibition, please contact Adam Falcone at email@example.com or call (202) 466-8960.
 Office of Inspector General (“OIG”), U.S. Department of Health and Human Services, “OIG Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak,” available at: https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/policy-telehealth-2020.pdf.
[ii] OIG, “FAQs—OIG Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak,” (as of March 24, 2020), available at: https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/telehealth-waiver-faq-2020.pdf.
[v] OIG, “OIG Policy Statement Regarding Application of Certain Administrative Enforcement Authorities Due to Declaration of Coronavirus Disease 2019 (COVID-19) Outbreak in the United States as a National Emergency,” available at: https://oig.hhs.gov/coronavirus/OIG-Policy-Statement-4.3.20.pdf.
[vi] HHS, “Blanket Waivers of Section 1877(g) of the Social Security Act Due to Declaration of COVID-19 Outbreak in the United States as a National Emergency,” available at: https://www.cms.gov/files/document/covid-19-blanket-waivers-section-1877g.pdf.
[vii] The OIG is accepting inquiries by email at OIGComplianceSuggestions@oig.hhs.gov and is posting its responses to questions here: https://oig.hhs.gov/coronavirus/authorities-faq.asp.