Authorities Frequently Asked Questions (FAQs)

Posted May 24, 2021

OIG is aware that a broad range of entities are offering a wide variety of incentives and rewards (e.g., food and beverages, tickets to concerts and baseball games, cash) to individuals who receive the COVID-19 vaccine. We recognize that effective, expeditious, and widespread vaccine administration is crucial to the COVID-19 pandemic response. We also understand that certain incentives and rewards may promote broader access to and uptake of COVID-19 vaccinations.

Because Medicare and other Federal health care programs reimburse for COVID-19 vaccine administration, the offer or provision of incentives and rewards to beneficiaries of these programs who receive the vaccine from a particular practitioner, provider, or supplier implicates the Federal anti-kickback statute and the Beneficiary Inducements CMP. Indeed, OIG has longstanding and continuing concerns about the provision of anything of value to Federal health care program beneficiaries intended to induce the utilization of reimbursable items or services-remuneration that likely would violate the Federal anti-kickback statute on its face.

We understand that some health care providers, suppliers, and managed care organizations have offered or provided or would like to offer or provide incentives or rewards to Federal health care program beneficiaries in connection with the beneficiary receiving a COVID-19 vaccine. In the limited context of the COVID-19 public health emergency, a health care provider, supplier, or managed care organization offering or providing a reward or incentive in connection with the beneficiary receiving the COVID-19 vaccine (either one or both doses) would be sufficiently low risk under the Federal anti-kickback statute and Beneficiary Inducements CMP if the following safeguards were met: (1) the incentive or reward is furnished in connection with receiving a required dose of a COVID-19 vaccine (which could include either one or two doses, depending on vaccine type); (2) the vaccine is authorized or approved by the Food and Drug Administration as a COVID-19 vaccine and is administered in accordance with all other applicable Federal and State rules and regulations and the conditions for the provider or supplier receiving vaccine supply from the Federal government; (3) the incentive or reward is not tied to or contingent upon any other arrangement or agreement between the entity offering the incentive or reward and the Federal health care program beneficiary; (4) the incentive or reward is not conditioned on the recipient's past or anticipated future use of other items or services that are reimbursable, in whole or in part, by Federal health care programs; (5) the incentive or reward is offered without taking into account the insurance coverage of the patient (or lack of insurance coverage) unless the incentive or reward is being offered by a managed care organization and eligibility is limited to its enrollees; and (6) the incentive or reward is provided during the COVID-19 public health emergency.

Many incentives and rewards currently offered to Federal health care program beneficiaries who receive the COVID-19 vaccine are offered and paid for by entities that are not affiliated or connected with any health care industry stakeholder (e.g., restaurants) or by governmental entities (e.g., local or State Departments of Health); those incentives and rewards have minimal risk under the Federal anti-kickback statute, and to the extent it is implicated, the Beneficiary Inducements CMP. Incentives or rewards offered and funded by such entities would not be an enforcement priority for OIG, and absent some other fraud scheme, OIG would not bring an administrative enforcement action based on the offer or provision of such COVID-19 vaccine incentives and rewards. The Federal anti-kickback statute and Beneficiary Inducements CMP relate to items and services for which payment may be made in whole or in part under a Federal health care program. Consequently, it is unlikely that these statutes would be implicated by incentives and rewards furnished to commercially insured or uninsured individuals.

OIG expresses no opinion on the merits or utility of any particular incentive or reward to address the goal of encouraging vaccination; this FAQ is limited to application of OIG's administrative enforcement authorities.

Posted May 5, 2021

While an ambulance provider or supplier waiving or discounting beneficiary cost-sharing obligations resulting from ground ambulance services paid for by the Medicare program under a waiver established pursuant to section 1135(b)(9) of the Social Security Act would implicate the Federal anti-kickback statute and Beneficiary Inducements CMP, OIG believes that such discounts or waivers would represent a sufficiently low risk of fraud and abuse under those statutes, provided the ground ambulance services are billed in accordance with the waiver described further below. In response to the COVID-19 public health emergency, various State, local, or municipal authorities (including hospitals, but only where a hospital has the requisite legal authority) have established communitywide emergency medical service (EMS) protocols that require or allow, with patient consent, ambulance providers and suppliers to treat certain patients, including Medicare beneficiaries, "in place" who otherwise, but for the COVID-19 public health emergency, would have been transported to a Medicare covered destination (such as a hospital). In light of these EMS protocols, on May 5, 2021, pursuant to section 1135(b)(9) of the Social Security Act, the Secretary of Health and Human Services waived certain statutory requirements relating to Medicare payments for ground ambulance services furnished in response to a 911 call (or the equivalent in areas without a 911 call system) in cases in which an individual would have been transported to a destination permitted under Medicare regulations but such transport did not occur as a result of communitywide EMS protocols established due to the public health emergency (the Waiver). The Waiver is effective retroactively to Medicare claims for services rendered on or after March 1, 2020.

Pursuant to the Waiver, ground ambulance services under such circumstances will be paid at the usual base rate based on the level of service that was provided-Basic Life Support (BLS) emergency or Advanced Life Support, level 1 (ALS1) emergency-that would have been paid if the patient had in fact been transported to the nearest appropriate facility able to treat the patient's condition and other means of transportation were contraindicated, without payment for mileage. Documentation to support medical necessity and the qualifying communitywide EMS protocols must be maintained by the ambulance providers and suppliers and provided to CMS contractors, such as part of a medical review, upon request. Under the Ambulance Fee Schedule, Medicare Part B pays 80 percent of the approved amount, and the beneficiary is responsible for 20 percent of the approved amount as well as the applicable Part B deductible, if it has not yet been met. OIG has become aware that some ambulance providers and suppliers may wish to waive or discount beneficiary cost-sharing obligations in the context of services provided and billed to Medicare under the flexibilities provided by the Waiver.

Routine waivers of cost-sharing obligations implicate the Federal anti-kickback statute and the civil monetary penalty provision prohibiting inducements to beneficiaries and may result in overutilization or inappropriate utilization of items and services reimbursable by Federal health care programs. We recognize, however, that beneficiary obligations that arise as a result of billing by ambulance providers or suppliers under the Waiver could result in the perception of "surprise billing," particularly with respect to retroactive billing for services that were provided prior to the issuance of the Waiver. In addition, in the context of ground ambulance services performed prior to the issuance of the Waiver, ambulance providers and suppliers would have had no expectation that the Medicare program would reimburse for services that did not involve an actual transport, and there was no expectation on the part of the beneficiaries receiving services that they would have incurred cost-sharing obligations. Therefore, a retroactive waiver of cost-sharing obligations by ground ambulance providers and suppliers for instances in which no ambulance transport was provided but for which the Medicare program retroactively reimburses for these specified services is unlikely to induce the use of those or any other services in the future. Accordingly, under the unique circumstances of the COVID-19 public health emergency, and in the context of the Waiver cited above, OIG believes it would represent a sufficiently low risk of fraud and abuse for ground ambulance providers and suppliers to waive or discount beneficiary cost sharing obligations for claims billed in accordance with the Waiver.

Posted March 24, 2021

We recognize that effective and expeditious vaccine administration is crucial to the COVID-19 pandemic response and that individuals in rural areas may face heightened challenges in accessing vaccines. In the facts presented, the FQHC would provide the free use of space for the pharmacy to operate a vaccination clinic. The pharmacy would direct and operate all aspects of the vaccination clinic, including obtaining patient consents; administering COVID-19 vaccinations to individuals, some of whom may be Federal health care program beneficiaries; observing patients after vaccination and responding to any adverse reactions; and providing all items and services related to vaccine administration (e.g., staff and equipment). According to the FQHC, other than the free use of space, no remuneration would be exchanged between the parties. With respect to a patient of the FQHC who receives a vaccine administered by the pharmacy, the FQHC would maintain a record of vaccine administration within the patient's medical record.

OIG's longstanding guidance makes clear that, depending on the facts and circumstances, the provision of free space to an actual or potential referral source likely implicates the Federal anti-kickback statute and would not satisfy the requirements of the space rental safe harbor, 42 C.F.R. § 1001.952(b). Nevertheless, we believe that the provision of space at no charge by an FQHC in a rural area for a pharmacy to administer COVID-19 vaccinations would pose a low risk of fraud and abuse under the Federal anti-kickback statute because of the unique circumstances of the COVID-19 public health emergency and could address challenges in vaccine access for individuals in rural areas.

Posted February 17, 2021

A non-provider philanthropic organization (the Organization) wishes to provide certain administrative services, described further below, to support the development and operation of COVID-19 vaccination sites. The Organization would contract with various health care providers (HCPs), including physicians, physician group practices, and health systems, to provide these administrative services. The HCPs would oversee administration of the COVID-19 vaccine and provide certain clinical staffing to administer the vaccine at the sites. HCPs also would bill third-party payors, including Federal health care programs, for vaccine administration services.

The Organization and each HCP would enter into a signed, written agreement setting forth the duties of each party and the methodology for determining the compensation the HCP pays to the Organization. Under its agreements with HCPs, the Organization would provide the following administrative services: arranging for the physical vaccination sites, data systems, online and web-based scheduling, site development and training, and reporting to state agencies. The Organization stated that it has the experience and expertise to provide reliable administrative services for vaccination sites. In addition, the Organization stated that the vaccination sites would be operated in accordance with guidelines from the state health department and the U.S. Centers for Disease Control and Prevention, including that the sites would administer the COVID-19 vaccine regardless of the vaccine recipient's insurance coverage status. The Organization also explained that the COVID-19 vaccines administered at the sites would be approved by the U.S. Food and Drug Administration (FDA) or subject to an FDA-issued Emergency Use Authorization. Finally, the Organization's provision of administrative services to HCPs would not operate in conjunction with any other arrangement or agreement between and among the Organization, the HCPs, any Federal health care program beneficiary who receives vaccinations from one of the sites, or any other person or entity in a position to refer or arrange for the referral of items or services reimbursable by a Federal health care program.

As compensation for the enumerated administrative services, each HCP would share a portion of the vaccine administration fees the HCP collects from third-party payors, including Federal health care programs, with the Organization as follows: After the HCP retains a certain amount per hour for the HCP's compensation and to cover the staffing costs associated with the clinicians who administer the vaccine under the HCP's supervision, the HCP would distribute the remaining vaccine administration fee amounts to the Organization. In other words, the compensation to the Organization could vary based on the number of vaccine doses the HCP administers.

Compensation methodologies that involve "per patient," "per click," "per order," and similar methodologies in payment arrangements with parties in a position, directly or indirectly, to refer or recommend an item or service payable by a Federal health care program implicate and may violate the Federal anti-kickback statute. OIG has previously expressed concerns that such compensation arrangements could promote overutilization. However, under the facts described herein, the payment of compensation by HCPs to the Organization in the form of a share of vaccine administration fees paid by third-party payors, including Federal health care programs, presents a sufficiently low risk of fraud and abuse under the Federal anti-kickback statute because of the unique circumstances of the COVID-19 public health emergency, the low risk of overutilization, and the safeguards incorporated into the arrangement, as described above.

Posted December 14, 2020

An FQHC has received funding from a non-governmental donor to be used to provide free COVID-19 diagnostic testing to vulnerable populations that may have difficulty accessing testing due to low income, lack of transportation, or other barriers. Free COVID-19 diagnostic testing would be provided on a first-come-first-served basis and would not be tied to receiving any other items or services from the FQHC. In addition, the FQHC would not offer special discounts on additional items or services to patients who receive free testing. If a patient received a positive test result, the patient would be directed to the provider of his or her choice and would not be directed to the FQHC or any other specific provider. The FQHC would not bill the COVID-19 testing to any Federal health care program, other third-party payors, or the patient. The FQHC intends to advertise the availability of free testing.

In earlier FAQs, we have recognized that FQHCs deliver care to some of the nation's most vulnerable individuals and families, which can include Federal health care program beneficiaries. In addition, we recognize that the availability of COVID-19 testing may be critical to combatting the current public health emergency. Under the facts described herein, the provision of free COVID-19 diagnostic testing to Federal health care program beneficiaries presents a sufficiently low risk of fraud and abuse under the Federal anti-kickback statute and Beneficiary Inducements CMP because, as described, the program includes the following safeguards: (1) free COVID-19 testing is offered to all patients who request it, regardless of the patient's insurance coverage or lack thereof; (2) beneficiaries who received positive test results would not be referred to the FQHC or to any other specific provider; (3) the FQHC would not offer special discounts or any other free or discounted items or services to beneficiaries who received free COVID-19 testing; (4) no payor, including the beneficiary, a commercial insurance company, or a Federal health care program, would be billed for or pay any costs in connection with the COVID-19 testing services; and (5) the COVID-19 tests are cleared or approved by the Food and Drug Administration (FDA), are subject to an FDA-issued Emergency Use Authorization, or are covered by the Medicare program.

This response addresses only the provision of free COVID-19 testing by the FQHC to Federal health care program beneficiaries. Providing free testing to individuals who are not Federal health care program beneficiaries would be unlikely to implicate the Federal anti-kickback statute or Beneficiary Inducements CMP. In addition, we recognize that this scenario also involves potential direct or indirect financial relationships between the non-governmental donor entity providing funding, the FQHC, and Federal health care program beneficiaries, and there are different potential fraud and abuse risks with respect to those relationships. Because no information was provided with respect to the donor, and given the numerous potential variations on the facts depending on the nature of donors, this response focuses only on the financial relationship between the FQHC and the Federal health care program beneficiary receiving free COVID-19 testing services from the FQHC. 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 FQHC or Federal health care program beneficiaries.

Posted December 10, 2020

Under some state and regional COVID-19 vaccine plans, providers and suppliers such as hospitals, pharmacies, and health systems play a critical role in the storage, distribution, redistribution, and administration of COVID-19 vaccines. In this role, providers and suppliers may furnish free items and services (e.g., vaccine cold or ultracold storage, staff time, and supplies) to other providers and suppliers that are actual or potential Federal health care program referral sources. For example, under some State plans certain providers and suppliers assume responsibility for storing COVID-19 vaccines in cold or ultracold storage and redistributing (which includes, in certain instances, transporting) vaccines to other providers and suppliers, some of which may be actual or potential referral sources.

We recognize that effective and expeditious vaccine distribution, redistribution, and administration is crucial to the COVID-19 pandemic response. We also acknowledge that 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 that guidance, a provider or supplier furnishing free COVID-19 vaccine-related items or services to other providers and suppliers could raise concerns under the Federal anti-kickback statute.

However, we believe that the provision of free items and services related to COVID-19 vaccine storage, distribution, redistribution, and administration would pose a low risk of fraud and abuse under the Federal anti-kickback statute. As such, and except as provided in the last paragraph below, OIG would not take enforcement action against a provider or supplier that furnishes free or discounted goods or services related to COVID-19 vaccine storage, distribution, redistribution, and/or administration. It is unlikely that such a provider or supplier would have the requisite intent to induce or reward patient referrals, or generate Federal health care program business, by furnishing such goods or services.

The factors relevant to this assessment include, but are not limited to, the unique circumstances of the COVID-19 public health emergency, the key role of providers and suppliers under current plans related to distribution of COVID-19 vaccines approved or authorized by the Food and Drug Administration (FDA), and that such items and services are furnished consistent with a state or regional COVID-19 vaccine plan submitted to the Centers for Disease Control and Prevention, or are otherwise furnished at the direction of or in coordination with Federal, state, or local public health officials.

We note that the same factors would not be present for providers, suppliers, or other individuals and entities that distribute, redistribute, or administer adulterated, counterfeit, or fraudulent COVID-19 vaccines, or that otherwise attempt to induce or generate Federal health care program business by providing free items and services in connection with COVID-19 vaccines or other medical countermeasures not approved or authorized by the FDA. The latter conduct would be suspect under the Federal anti-kickback statute, and both types of conduct may implicate other criminal and civil statutes.

Posted September 3, 2020

We recognize that FQHCs deliver care to some of the nation's most vulnerable individuals and families, including Federal health care program beneficiaries. During the COVID-19 public health emergency, some patients who receive care from FQHCs may be experiencing additional financial hardships. As safety net providers, FQHCs are well-positioned to identify these hardships and provide assistance to patients to address social determinants of health (e.g., food insecurity, housing instability, and transportation).

OIG has longstanding and continuing concerns regarding the provision of cash or cash equivalents to Federal health care program beneficiaries. However, under the facts presented to us, the COVID-19 relief grant was specifically designated for emergency cash assistance to individuals and, in the limited context of the COVID-19 public health emergency and with the combination of safeguards presented below, distributing the grant funds to individuals including Federal health care program beneficiaries in the form of cash-equivalent gift cards would be sufficiently low risk. Specifically, based on the facts included in the question submitted to us, the distribution of grant funds would be administered through one of the FQHC's social services programs, and the FQHC would:

(1) screen for financial need (demonstrated by an individual's enrollment in Medicaid or by an uninsured individual's attestation of annual income);

(2) screen for COVID-19-related financial need to confirm that an individual has lost more than 50 percent of his or her income due to the COVID-19 public health emergency;

(3) document each individual's satisfying of the two-pronged financial need criteria;

(4) explain to a recipient, and require a signed acknowledgment from each recipient, that eligibility for the cash assistance is not tied to becoming a patient of the FQHC, or for individuals who are the FQHC's patients continuing to receive care from the FQHC;

(5) limit any cash-equivalent gift card to $100 to $200 (depending on family size);

(6) track to ensure a patient receives gift card assistance only once; and

(7) refrain from advertising the program. In addition, individuals would be screened for eligibility after being referred to the FQHC for case management services,

but the offer or provision of gift cards would not be conditioned on the individual's past or anticipated future use of the FQHC's services reimbursable in whole or in part by Federal health care programs.

This response addresses only the distribution of gift cards from the FQHC to Federal health care program beneficiaries. We recognize that this scenario also involves potential direct or indirect financial relationships between the private foundation, the FQHC, and the Federal health care program beneficiary receiving the grant funding, and that there are different fraud and abuse risks with respect to each relationship. Given the numerous potential variations on the facts related to donors, this response focuses only on the financial relationship between the FQHC and the Federal health care program beneficiary receiving grant funding. 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 FQHC or Federal health care program beneficiary.

Posted September 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 of Federal health care program business may implicate the Federal anti-kickback statute. Similarly, depending on the facts and circumstances, providing 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 an HHA and an assisted living facility could work together to fill critical gaps caused by the COVID-19 outbreak to provide necessary health care services to vulnerable beneficiaries residing in an assisted living facility. Facilitating blood draws for medically necessary clinical laboratory testing in a patient's residence may improve access to care and promote patient safety during the current pandemic by avoiding exposure to a separate testing site.

In the unique circumstances resulting from the COVID-19 outbreak, we believe that these facts likely would present a low risk of fraud and abuse under the Federal anti-kickback statute and the Beneficiary Inducements CMP provided the free blood draw services being offered by an HHA—through its staff members—to Federal health care program beneficiaries who are not patients of the HHA and reside in an assisted living facility are: (1) within the scope of practice of the HHA's staff; (2) limited to the period subject to the COVID-19 Declaration; and (3) not contingent upon 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. In addition, no party may bill or otherwise shift the costs of free blood draws to Federal health care programs.

Posted August 4, 2020

According to the facts presented, a clinical laboratory would provide free COVID-19 antibody testing to patients, including Federal health care program beneficiaries, who contemporaneously undergo other medically necessary blood tests performed by the laboratory. The laboratory's stated purpose for the arrangement is to increase patient awareness of antibodies to promote donations of COVID-19 blood plasma, which could be used for certain experimental convalescent plasma therapy treatments for COVID-19. The laboratory would not charge any patient or other payor for the COVID-19 antibody tests. Patients and physicians would be able to access COVID-19 antibody testing results through the laboratory's patient portal, and the results from the antibody testing program also would be reported to the Centers for Disease Control and Prevention and State public health agencies to further support COVID-19 surveillance and response efforts.

Providing free laboratory testing to Federal health care program beneficiaries implicates the Federal anti-kickback statute because the clinical laboratory would be providing something of value for free to beneficiaries who could self-refer to the laboratory for items and services reimbursable by a Federal health care program. The proposed arrangement also implicates the Beneficiary Inducements CMP because the free COVID-19 antibody testing could reasonably influence a Medicare or State health care program beneficiary to select—or to cause his or her physician to select—the clinical laboratory for other medically necessary blood testing that is reimbursable by Medicare or a State health care program, in order to qualify for the free COVID-19 antibody testing.

We believe the proposed arrangement offers the possibility of substantial public health benefits through the identification of additional potential convalescent plasma donors and valuable public health information and data and would pose a sufficiently low risk of fraud and abuse, provided the proposed arrangement includes the following safeguards: (1) the physicians ordering the laboratory tests, including the free COVID-19 antibody tests, would not receive any payments or anything else of value from the clinical laboratory in connection with the free antibody testing program; (2) the patients receiving the laboratory tests would not receive any payments or anything of value, other than the free COVID-19 antibody test, from the clinical laboratory in connection with the free antibody testing program; (3) the tests would be offered only to patients receiving other medically necessary blood tests as part of a medically necessary exam or treatment; (4) no payor, including the patient, a commercial insurance company, or a Federal health care program, would be billed for or pay any costs in connection with the COVID-19 antibody tests; and (5) the antibody tests are cleared or approved by the U.S. Food and Drug Administration (FDA) or are subject to an FDA-issued Emergency Use Authorization.

Posted July 29, 2020

We understand that Federal health care program beneficiaries with cancer, who are receiving chemotherapy or radiation treatment, sometimes qualify for free or discounted housing at a nonprofit lodging facility near treatment sites while receiving treatment. We also understand that some of these lodging facilities have closed as a result of the COVID-19 public health emergency. We further understand that some patients with cancer, including Federal health care program beneficiaries, must travel longer distances from their homes to receive chemotherapy or radiation treatment because of practice closures or consolidation of practice sites resulting from the COVID-19 public health emergency.

According to the facts presented in the question submitted, an oncology practice wishes to offer free or discounted lodging to certain financially needy patients who would have qualified for free or discounted lodging at a nonprofit lodging facility that is now closed as a result of the COVID-19 public health emergency. Under the unique circumstances resulting from the COVID-19 outbreak, we believe that the provision of free or discounted lodging by an oncology practice to financially needy Federal health care program beneficiaries otherwise eligible for lodging at a nonprofit lodging facility presents a low risk of fraud and abuse if certain conditions are met. We also acknowledge that it may be possible for parties to structure the provision of free or reduced-cost lodging to meet the Promotes Access to Care exception to the Beneficiary Inducements CMP (see, e.g., OIG Advisory Opinion 17-01), 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 believe an oncology practice's provision of free or discounted lodging to certain financially needy Federal health care program beneficiaries presents a low risk of fraud and abuse under the Federal anti-kickback statute and the Beneficiary Inducements CMP if the following conditions are met:

(1) the patient resides at least 50 miles from the treatment site;

(2) the patient is an established patient of the oncology practice who has already scheduled chemotherapy or radiation treatment prior to the offer of free or discounted lodging;

(3) the patient's physician determines that free or discounted lodging would facilitate access to care while the patient is receiving chemotherapy or radiation treatment;

(4) the oncology practice reasonably believes that the patient would have qualified for free or discounted housing during treatment at a nonprofit lodging facility that is closed as a result of the COVID-19 public health emergency;

(5) the remuneration is in-kind, such as a direct payment to a hotel or motel for the appropriate number of nights;

(6) the hotel or motel is located in close proximity to the treatment site;

(7) the practice does not advertise the availability of free or discounted housing or otherwise use the availability of this remuneration for patient recruitment; and

(8) the lodging is provided during the COVID-19 public health emergency.

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."