FAQs–Application of OIG's Administrative Enforcement Authorities to Arrangements Directly Connected to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Last Updated: 05-14-2020
The Office of Inspector General (OIG) recognizes that, in the current public health emergency resulting from the outbreak of the COVID-19, the health care industry must focus on delivering needed patient care.1 As part of OIG's mission to promote economy, efficiency, and effectiveness in HHS programs, we are committed to protecting patients by ensuring that health care providers have the regulatory flexibility necessary to adequately respond to COVID-19 concerns. Therefore, OIG is accepting inquiries from the health care community regarding the application of OIG's administrative enforcement authorities, including the Federal anti-kickback statute and civil monetary penalty (CMP) provision prohibiting inducements to beneficiaries (Beneficiary Inducements CMP).2 If you have a question regarding how OIG would view an arrangement that is directly connected to the public health emergency and implicates these authorities, please submit your question to OIGComplianceSuggestions@oig.hhs.gov. In your submission, please provide sufficient facts to allow for an understanding of the key parties and terms of the arrangement at issue.3 OIG will update the FAQ site as we respond to additional frequently asked questions.
The OIG's advisory opinion process remains available to interested parties. An OIG advisory opinion is a legal opinion issued by OIG to one or more requesting parties about the application of the OIG's fraud and abuse authorities to the party's existing or proposed business arrangement. An OIG advisory opinion is legally binding on HHS and the requesting party or parties. For more information about the advisory opinion process, including information regarding how to submit an advisory opinion and how long it takes for OIG to process an advisory opinion request, please see https://oig.hhs.gov/faqs/advisory-opinions-faq.asp.
The following limitations apply to these FAQs:
- The informal feedback furnished on this site does not bind or obligate HHS, the U.S. Department of Justice, or any other agency.
- Although we are making every attempt to provide an accurate response to questions posed in the context of the exigent circumstances unique to the COVID-19 public health emergency, due to the limited scope of facts presented to us—which are not certified—any favorable answer will not result in prospective immunity or protection from OIG administrative sanctions or prospective immunity or protection under Federal criminal law.
- OIG expresses no opinion with respect to the application of any other Federal, State, or local statute, rule, regulation, ordinance, or other law that may be applicable to the question answered, including, without limitation, the physician self-referral law, section 1877 of the Act (or that provision's application to the Medicaid program at section 1903(s) of the Act).4 Any answer provided here is not intended to be, and should not be construed as, a determination that an arrangement complies with the physician self-referral law or satisfies a statutory or regulatory exception or waiver to that law.
- OIG expresses no opinion regarding the liability of any party under the Federal False Claims Act, Federal criminal law, or other legal authorities for any improper billing, claims submission, cost reporting, or related conduct.
- The informal feedback here applies only to arrangements in existence solely during the time period subject to the COVID-19 Declaration.5 Given the unique circumstances surrounding the public health emergency, OIG may take a different position on arrangements that are the same or similar in nature that existed before the effective date of the COVID-19 Declaration or after the time such COVID-19 Declaration ends.
Posted May 14, 2020
We recognize that sufficient access to personal protective equipment is crucial to protect patients and frontline health care workers during the coronavirus disease 2019 (COVID-19) public health emergency. OIG's longstanding guidance makes clear that, depending on the facts and circumstances, providing free or discounted goods or services to an actual or potential referral source may violate the Federal anti-kickback statute. In light of such guidance, a physician group's provision of free or reduced-cost masks to nursing homes where they provide care to Federal health care program beneficiaries could raise concerns under the anti-kickback statute. However, given the unique circumstances of the COVID-19 public health emergency, we believe that the provision of free or reduced-cost masks would pose a low risk of fraud and abuse under the Federal anti-kickback statute provided that (1) the decision to furnish masks for free or at a reduced cost is directly connected to addressing the impact of the COVID-19 outbreak (e.g., the nursing home needs masks due to COVID-19 supply chain disruptions); (2) the masks are furnished only during the time period subject to the COVID-19 Declaration; (3) the provision of free or reduced-cost masks is not marketed by the physician group; and (4) the provision of the masks is not made contingent on the nursing home's referrals to the physician group of any specified item or service, or any specified volume or value of past or anticipated referrals of items or services that may be reimbursable, in whole or in part, by a Federal health care program.
We recognize that the donation of face masks under these circumstances presents a lower risk of fraud and abuse because it operates to protect the health and safety of the donor physician group and its treating clinicians who furnish services to the nursing home's residents during the public health emergency and who may work closely with the nursing home's staff.
Posted May 8, 2020
According to the facts presented, the retail pharmacy would set up COVID-19 testing collection sites and would incur certain costs associated with running these sites (e.g., personal protective equipment for employees, scheduling services, processing and sending the specimens). The clinical laboratory would bill payors, including Federal health care programs, for the laboratory tests, and it would pay the retail pharmacy a fair market value fee for the costs described above associated with running the collection sites. The arrangement would implicate the Federal anti-kickback statute because the clinical laboratory would pay remuneration to a referral source (i.e., the retail pharmacy).
Our longstanding guidance makes clear that "[w]henever a laboratory offers or gives to a source of referrals anything of value not paid for at fair market value, the inference may be made that the thing of value is offered to induce the referral of business." OIG, Special Fraud Alert: Arrangements for the Provision of Clinical Laboratory Services (Oct. 1994), available at https://oig.hhs.gov/compliance/alerts/index.asp (the "1994 Alert"). Moreover, a 2014 Special Fraud Alert described certain problematic "specimen processing arrangements" in which clinical laboratories provided remuneration to physicians to collect, process, and package patients' specimens, and we noted there that "when a laboratory pays a physician more than fair market value for the physician's services or for services . . . for which the physician is otherwise compensated, the anti-kickback statute is implicated" and explained that "[s]uch payments are suspect under the anti-kickback statute because of the implication that one purpose of the payments is to induce the physician's Federal health care program referrals." OIG, Special Fraud Alert: Laboratory Payments to Referring Physicians (June 2014), available at https://oig.hhs.gov/compliance/alerts/index.asp (the "2014 Alert"). In the circumstances described in the 2014 Alert, the Medicare program reimbursed physicians for processing and packaging specimens for transport to a clinical laboratory through a bundled payment reported under a particular Current Procedural Terminology code. We stated that if the services for which the laboratory compensated the physician were paid for by a third party through other means, any payment by the laboratory to the physician for the physician's services could constitute double payment that evidenced unlawful intent under the Federal anti-kickback statute.
Because the facts presented here differ from those in the 1994 Alert and the 2014 Alert, we believe that the proposed arrangement between the clinical laboratory and retail pharmacy, in the context of the COVID-19 public health emergency, would be sufficiently low risk under the following circumstances: (i) the retail pharmacy incurs costs in operating the testing collection sites; (ii) the payment is fair market value for the items and services furnished by the retail pharmacy in running the sites; and (iii) the retail pharmacy is not submitting claims to Federal health care programs—or directly or indirectly receiving other Federal or State funding—that reimburse it, in whole or in part, for the items and services furnished by the retail pharmacy in running the sites for which the laboratory reimburses the pharmacy. In contrast, if the pharmacy were to bill Federal health care programs for—or otherwise were to receive Federal or State funding (e.g., through the Coronavirus Aid, Relief, and Economic Security Act) to cover the costs associated with—the items and activities for which the clinical laboratory would reimburse the pharmacy, such remuneration could constitute a problematic double payment and could evidence unlawful intent under the Federal anti-kickback statute. It is incumbent on the parties to determine a fair market value payment for the actual and necessary items and services furnished by the retail pharmacy; we express no opinion regarding the fair market value for such items and services.
Posted May 1, 2020
The "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" does not incorporate sections II(B)(12)-(18) of the blanket waivers of the physician self-referral law as issued by the Secretary. Sections II(B)(12)-(17) of the blanket waivers of the physician self-referral law protect "referrals," as defined under section 1877(g) of the Act, rather than "remuneration," and reflect differences in the statutory proscriptions of the physician self-referral law when compared to the Federal anti-kickback statute. Section II(B)(18) of the blanket waivers protects a compensation arrangement that is neither set forth in writing nor signed by the parties but otherwise fully complies with an applicable physician self-referral law exception. For parties analyzing referrals by physicians for designated health services to entities under sections II(B)(12)-(17) of the blanket waivers under the Federal anti-kickback statute, we advise parties to consider whether such referrals would result in remuneration that implicates the Federal anti-kickback statute. For parties analyzing an arrangement neither set forth in writing nor signed by the parties but that otherwise fully complies with an applicable physician self-referral law exception, we advise parties to consider whether any remuneration stemming from the arrangement implicates the Federal anti-kickback statute. If, after such analysis, the parties remain concerned about OIG pursuing administrative enforcement authority in connection with remuneration related to such referrals or arrangement, we invite the parties to submit questions to OIGComplianceSuggestions@oig.hhs.gov. In your submission, please provide sufficient facts that allow for an understanding of the key parties and terms of the arrangement at issue.
Posted May 1, 2020
FQHCLAs deliver comprehensive primary care services to some of the country's most vulnerable individuals and families in areas where economic, geographic, or cultural barriers may limit access to affordable health care services. It is our understanding that many FQHCLAs and other providers face financial strain in light of the COVID-19 public health emergency due to shifting demands for health care items and services and, consequently, decreased revenue. Some hospitals may be in a position to provide certain relief to FQHCLAs by, for example, suspending rent or forgoing the accrual of interest on loans or lines of credit, which could allow FQHCLAs to continue to serve medical needs in underserved communities during the public health emergency.
In light of the unique circumstances of the current public health emergency, the Secretary has offered regulatory flexibilities to health care entities similar to those requested here via Blanket Waivers of Section 1877(g) of the Social Security Act (the Act), issued March 30, 2020 (the Blanket Waivers). On April 3, 2020, OIG issued a Policy Statement announcing it will exercise enforcement discretion for various categories of remuneration described by the Blanket Waivers, including the following categories relevant to this FAQ:
- Rental charges paid by a physician (or an immediate family member of a physician) to an entity that are below fair market value for the physician's (or immediate family member's) lease of office space from the entity.
- Remuneration from an entity to a physician (or the immediate family member of a physician) resulting from a loan to the physician (or the immediate family member of the physician): (1) with an interest rate below fair market value; or (2) on terms that are unavailable from a lender that is not a recipient of the physician's referrals or business generated by the physician.
A FQHCLA is not a physician or physician organization for purposes of section 1877 of the Act, and therefore this remuneration is not covered by the enforcement discretion described in the Blanket Waivers or the OIG Policy Statement. Nevertheless, OIG believes that a hospital's suspension of rental charges and accrual of interest for a FQHCLA presents a sufficiently low risk of fraud and abuse so long as the following conditions are met: (i) the arrangement suspending rental charges and accrual of interest is set out in a written document or documents, signed by the parties, that describes all material terms of the arrangement (which could be in the form of amendments to the underlying lease and line-of-credit agreements); (ii) the suspension of rent and accrual of interest is not conditioned on the volume or value of Federal health care program business generated between the hospital and the FQHCLA; (iii) the arrangement does not require the FQHCLA (or its affiliated health care professionals) to refer patients to a particular individual or entity or restrict the FQHCLA (or its affiliated health care professionals) from referring patients to any individual or entity; (iv) the suspension of rent and accrual of interest is only offered to the FQHCLA when necessary as a result of the COVID-19 outbreak; and (v) the suspension of rent and accrual of interest is effective only during the period subject to the COVID-19 Declaration.
Posted April 24, 2020
This question is outside the jurisdiction of OIG's authorities. However, providers may find more information about the CARES Act Provider Relief Fund and reach the attestation portal here: https://www.hhs.gov/provider-relief/index.html.
Posted April 23, 2020
We recognize the need during the COVID-19 outbreak for many health care providers and suppliers to furnish services through various modalities in lieu of in-person visits. We also acknowledge that some vulnerable patient populations may not own or have access to the necessary technology or data services to facilitate these services. The provision of valuable technology and services to Federal health care program beneficiaries for free or at a reduced cost likely implicates the Federal anti-kickback statute and Beneficiary Inducements CMP; in normal circumstances, offering or giving Federal health care program beneficiaries such items or services would be suspect under both laws.
In the limited context of the COVID-19 outbreak and in light of certain flexibilities in coverage for various telehealth and other virtual services payable by Federal health care programs, we believe the provision of a cell phone, service or data plan, or both (individually or collectively, "Telecommunications Technologies") by a mental health or substance use disorder provider to a patient likely presents a sufficiently low risk of fraud and abuse so long as the arrangement includes the following safeguards: (i) the provider determines in good faith that the patient is in financial need in advance of providing the Telecommunications Technologies; (ii) the provider determines in good faith that the patient requires Telecommunications Technologies to access medically necessary services related to his or her mental health or substance use disorder treatment; (iii) all services furnished using the Telecommunications Technologies are medically necessary, which lowers the risk of overutilization or inappropriate utilization; (iv) the provider uses the third party's funding solely for Telecommunications Technologies; (v) the provider does not market the Telecommunications Technologies (e.g., offer or provide free phones to generate business); (vi) the provider offers the Telecommunications Technologies only to "established patients" as that term is defined under 42 C.F.R. § 1001.952(bb); and (vii) the provision of the Telecommunications Technologies is limited to the time period subject to the COVID-19 Declaration, requiring the return of the cell phone, cessation of payment for the patient's service or data plan, or both, after the time period subject to the COVID-19 Declaration. We also acknowledge that it may be possible for parties to structure a program to meet the Promotes Access to Care exception to the Beneficiary Inducements CMP (see, e.g., OIG Advisory Opinion 19-02), but we are unable to make this determination without all the relevant facts, and we further note that there is no parallel safe harbor for protection under the Federal anti-kickback statute.
We recognize that this scenario involves potential direct or indirect financial relationships between donors, providers, and patients and that there are different fraud and abuse risks with respect to each relationship. Under certain circumstances, such as the Federal Communications Commission distributing grants to certain providers to fund Telecommunications Technologies, the remuneration (i.e., the grant funds) from the "donor" (i.e., the Federal Government) to the provider would not implicate the Federal fraud and abuse laws. However, under other circumstances, arrangements between the donor and the provider, or indirect financial relationships between the donor and the patient, could implicate–and present risk under–the Federal fraud and abuse laws. Given the numerous potential variations on the facts related to donors, this response focuses only on the financial relationship between the provider and patient. Parties must separately assess any fraud and abuse risks that may arise with respect to any direct or indirect financial relationships between the donor and the provider or patient.
Posted April 23, 2020
According to the facts presented, an oncology group practice has temporarily closed a particular office due to actual or potential patient and staff exposure to COVID-19. During the closure, the group practice desires to provide established patients with modest transportation assistance (e.g., a voucher or reimbursement for taxi or ridesharing services or a driver or ridesharing service paid for by the practice) to assist them in obtaining oncology care at one of the group practice's alternate locations. While the group practice may be able to structure such transportation arrangements to comply with the existing safe harbor for local transportation, 42 C.F.R. § 1001.952(bb), we understand that the transportation the oncology group practice would like to provide may not always meet every requirement of this safe harbor; for example, the travel distance between a patient's home and the alternate practice location may exceed the mileage limitations associated with that safe harbor.
In addition to the facts presented, we also believe that many urban beneficiaries who normally use public transportation (e.g., bus or subway) to access oncology care may temporarily need modest transportation assistance during the COVID-19 Declaration. For example, the oncology group practice may desire to provide transportation assistance for patient safety reasons to prevent the risk of COVID-19 exposure to patients while using public transportation.
In-kind transportation services offered by an oncology group practice to Federal health care program beneficiaries for free constitutes remuneration that may violate the Federal anti-kickback statute if the requisite intent to induce referrals is present. This remuneration also could reasonably influence a patient to select the group practice to receive federally reimbursable items and services. Accordingly, the arrangement implicates the Beneficiary Inducements CMP.
Under the unique and exigent circumstances resulting from the COVID-19 outbreak, we believe that modest, in-kind transportation assistance (e.g., a voucher or reimbursement for taxi or ridesharing services or a driver or ridesharing service paid for by the practice)-that does not otherwise satisfy the conditions set forth in the existing safe harbor for local transportation-provided for free to established patients of an oncology practice would present a low risk of fraud and abuse under the Federal anti-kickback statute and the Beneficiary Inducements CMP and could improve beneficiaries' access to oncology care in certain circumstances. In particular, we believe such transportation assistance would present low risk so long as the transportation assistance is: (i) provided by an "eligible entity" to an "established patient," as those terms are defined under 42 C.F.R. § 1001.952(bb), for free or at reduced cost to obtain medically necessary items or services furnished by the eligible entity; (ii) provided only when necessary as a result of the COVID-19 outbreak and during the period subject to the COVID-19 Declaration; and (iii) not air, luxury, or ambulance-level transportation. In addition, for the transportation assistance to present a low risk of fraud and abuse, the eligible entity must not: (i) determine an established patient's eligibility for transportation assistance in a manner related to the past or anticipated volume or value of Federal health care program business; (ii) publicly market or advertise the in-kind transportation or allow marketing of health care items and services during the course of the transportation or at any time by drivers who provide the transportation; or (iii) pay drivers or others arranging for the transportation on a per-beneficiary-transported basis.
We recognize that many physicians who prescribe extended courses of treatment such as chemotherapy, dialysis, radiation therapy, cardio/pulmonary rehabilitation treatment, or behavioral health services to beneficiaries may desire to provide transportation assistance to mitigate the effects of office closures caused by the COVID-19 outbreak or increased risk of exposure to COVID-19 for patients who use public transportation to access care. We believe that transportation assistance provided by these categories of providers in accordance with the conditions set forth above also would likely present a low risk of fraud and abuse.
Posted April 3, 2020
OIG's longstanding guidance makes clear that, depending on the facts and circumstances, the provision of free goods or services to an actual or potential referral source may violate the Federal anti-kickback statute; similarly, depending on the facts and circumstances, the provision of free goods or services to Federal health care program beneficiaries may implicate the Beneficiary Inducements CMP. However, we believe that there are scenarios in which health care providers could work together to fill critical gaps caused by the COVID-19 outbreak to provide necessary care to vulnerable beneficiaries receiving care in a SNF or other long-term-care facility. For example, we understand that some essential staff at SNFs and other long-term-care providers may be unable to report to work due to a lack of childcare, and we received a question about whether a hospice vendor that is already providing services to some patients at a SNF could furnish certain basic care needs—not to exceed the scope of the hospice's or the hospice staff's licenses—for free to patients who are not the hospice's clients to help mitigate any staffing shortages. Similarly, we received a question about a SNF or other long-term-care provider filling patient-care needs as a result of staffing shortages with, for example, community dentists or podiatrists who otherwise are not practicing at full capacity during the current public health emergency and are willing to offer their services for free or at a reduced rate to the SNF's patients on a temporary basis.
In the unique circumstances resulting from the COVID-19 outbreak, we believe that these scenarios likely would present a low risk of fraud and abuse under the Federal anti-kickback statute and the Beneficiary Inducements CMP provided the services being offered are (i) necessary to meet patient care needs as a result of staffing shortages directly connected to the COVID-19 outbreak; (ii) provided for free or at a reduced cost only when necessary as a result of the COVID-19 outbreak; (iii) limited to the period subject to the COVID-19 Declaration; and (iv) not contingent on referrals for any items or services that may be reimbursable in whole or in part by a Federal health care program, either during or after the COVID-19 Declaration period.
Posted April 10, 2020
According to the facts presented in the question we received, during the timeframe subject to the COVID-19 Declaration, the hospital would provide free access to a web-based telehealth platform to independent physicians on its medical staff. Such physicians could access the platform from various settings outside of the hospital's campus. The hospital would receive no payment from any (i) independent physician to whom it grants free access to the platform, or (ii) payor for services furnished through its telehealth platform by the independent physicians. In addition, independent physicians who use the hospital's telehealth platform for free (i) receive no remuneration for use of the platform from the hospital (other than free access to the platform); (ii) must be responsible for appropriately maintaining any required records for patients who receive services using the platform; and (iii) independently bill and receive reimbursement from payors for professional services furnished via the platform.
OIG's longstanding guidance makes clear that, depending on the facts and circumstances, the provision of free or below fair market value goods or services to an actual or potential referral source may violate the Federal anti-kickback statute. We recognize that access to the platform would provide independent value to the physicians-who may refer Federal health care program business to the hospital-and therefore would implicate the Federal anti-kickback statute. Nonetheless, in the unique and exigent circumstances resulting from the COVID-19 outbreak, we believe that free access to a hospital's telehealth platform by physicians on its medical staff would present a low risk of fraud and abuse under the Federal anti-kickback statute and could improve beneficiaries' access to telehealth services, so long as the platform is (i) provided for free to physicians to furnish medically necessary telehealth services; (ii) provided only when necessary as a result of the COVID-19 outbreak and during the period subject to the COVID-19 Declaration; (iii) not conditioned on the physician's past or anticipated volume or value of referrals to, or other business generated for, the hospital for any items or services that may be reimbursable in whole or in part by a Federal health care program; and (iv) offered to all physicians on the medical staff on an equal basis (but not necessarily accepted by every member to whom it is offered).
We encourage parties to review the recent guidance published by the Office for Civil Rights regarding the use of audio or video communication technology to furnish telehealth services during the COVID-19 public health emergency: "Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency."
1The Secretary of the Department of Health and Human Services (HHS) determined, through a January 31, 2020, determination, pursuant to section 319 of the Public Health Service Act, that a public health emergency exists and has existed since January 27, 2020. See U.S. Department of Health and Human Services, Determination that a Public Health Emergency Exists (Jan. 31, 2020), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx (COVID-19 Declaration).
2Section 1128B(b) of the Social Security Act (Act), 42 U.S.C. § 1320a-7b(b); section 1128A(a)(5) of the Act, 42 U.S.C. § 1320a-7a(a)(5).
3OIG plans to review all submissions, develop responses as appropriate to Frequently Asked Questions (FAQs), and make such responses publicly available on its website by updating this site. Your submission of a question does not obligate OIG to take action, including responding to the question, making the question public, or issuing public feedback.
442 U.S.C. § 1395nn; 42 U.S.C. § 1396b(s).
5Note that "[a public health emergency] declaration lasts until the Secretary declares that the [public health emergency] no longer exists or upon the expiration of the 90-day period beginning on the date the Secretary declared a [public health emergency] exists, whichever occurs first. The Secretary may extend the [public health emergency] declaration for subsequent 90-day periods for as long as the [public health emergency] continues to exist, and may terminate the declaration whenever he determines that the [public health emergency] has ceased to exist." See U.S. Department of Health and Human Services, Public Health Emergency Declaration Q&As, available at https://www.phe.gov/Preparedness/legal/Pages/phe-qa.aspx#faq7.