Articles Posted in Anti-Kickback

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When structuring healthcare arrangements, three major compliance challenges frequently emerge: the Stark Law (officially the Physician Self-Referral Law), the Anti-Kickback Statute (AKS), and the Eliminating Kickbacks in Recovery Act (EKRA). These laws govern referrals to or from a healthcare provider or supplier and carry the risk of severe, sometimes criminal, penalties. Yet, each also offers several exceptions or safe harbors that certain business models might meet. Even a simple arrangement with a healthcare entity can involve complex analysis regarding these three statutes.

The Stark Law (42 U.S.C. 1395nn) prohibits doctors from referring patients to entities providing “designated health services” covered by Medicare or Medicaid if there is a financial relationship between the physician (or their immediate family) and the entity, except under specific exceptions. Financial relationships subject to the Stark Law encompass both compensation and investment interests. Covered services range from clinical labs to physical and occupational therapy, durable medical equipment, certain imaging services, and more. Common exceptions include provisions for in-office ancillary services, fair market value compensation, and legitimate employment relationships. Recently, CMS introduced additional exceptions for value-based arrangements to accommodate evolving healthcare delivery models.

Similarly, the AKS (42 U.S.C. 1320a-7b(b)) criminalizes the exchange of “remuneration” to influence patient referrals or generate business for services billed to federal healthcare programs. “Remuneration” is broadly defined to include any item of value, not just cash. Nonetheless, where conduct implicates the AKS, it may still be lawful if the conduct fits within one of the statute’s “safe harbors,” which cover certain investments, rental agreements, and personal service contracts, among others. Recent updates have also added safe harbors for value-based healthcare arrangements, reflecting the industry’s shift towards this model.

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In November 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its General Compliance Program Guidance (GCPG). This guidance was released as part of OIG’s Modernization Initiative, which seeks to make compliance program guidance more user friendly and accessible. The document does not include new information but instead summarizes existing guidance regarding fraud and abuse risk, serving as an up-to-date comprehensive reference guide for the general healthcare community and industry stakeholders. OIG also noted that in 2024 it will begin publishing industry segment-specific CPGs (ICPGs) which will address compliance measures for industry subsectors.

The GCPG is not legally binding on any individual or entity, but contains valuable information regarding compliance with federal fraud and abuse statutes and regulations. The OIG guidance includes information regarding key fraud and abuse laws, the primary elements of an effective compliance program, program adaptations for small and large entities, other compliance considerations, and OIG resources and processes.

The GCPG begins with an overview of the principal federal fraud and abuse laws including the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (PSL; also known as the “Stark law”), the False Claims Act (FCA), and the Civil Monetary Penalty law (CMP). Their stated goal in summarizing these laws is to “create awareness and provide tools and resources to aid compliance efforts in both preventing violations and identifying potential red flags early with respect to these laws and regulations.”

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On October 10, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued an advisory opinion reinforcing the broad protection of physician employees under the safe harbor provision of the Anti-Kickback Statute (AKS). The AKS is a federal criminal law which prohibits payment for the inducement or reward of patient referrals or generation of business where any item or service payable by a federal healthcare program is involved.  Remuneration under the law has been interpreted to mean “the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind.” Violation of the AKS can result in severe penalties, including imprisonment of up to 10 years, a maximum fine of $100,000, and exclusions from Medicare and Medicaid reimbursement.

There are several statutory and regulatory exceptions to the AKS, which allow for specific remuneration arrangements when certain criteria are met. One statutory exception protects payments made by employers to employees who are in bona fide employment relationships for providing covered items and services under the employment agreement. Similarly, safe harbor regulations have been promulgated by HHS which clarify that “remuneration” under the AKS does not include payments under the bona fide employer-employee relationship described above.

In the recent advisory opinion, the OIG considered whether employer payment of bonuses based on net profits to employed physicians in a multi-specialty ambulatory surgery center (ASC) would constitute a violation of the AKS. The employer practice operated two separate ASCs – noted to be divisions and not subsidiaries – and planned to compensate physician employees via a bonus structure where employed physicians who performed procedures at the ASCs would receive 30% of the practice’s net profits in addition to base employment compensation. The OIG concluded that this type of arrangement would not violate the terms set forth in the AKS.

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released Advisory Opinion 23-04 (Advisory Opinion) on July 11, 2023, addressing arrangements between online healthcare directories and certain third-party websites (Directories) with federal healthcare program beneficiaries. In the Advisory Opinion, the OIG declined to impose sanctions on healthcare provider Directories offering these sort of advertising services to providers.

Under the proposed arrangement, healthcare provider Directories are serving as marketplaces in which users and potential patients can book medical appointments with physicians and other healthcare providers (Providers) who are listed on the online Directories. Patients can filter their results by searching for different types of medical providers, and the Directories generate personalized results using a proprietary algorithm.

Although no fee is charged to the patients for using the directory, Providers pay a fee to be included in the directory through an array of payment methods. Whenever potential patients click on a Provider’s profile during their searches, a “per-click” fee is charged to Providers. A “per-booking” fee is also charged to Providers for each new patient the Providers receive through the Directory which may vary in amount based on location, specialty, and other factors impacting the fair market value of the marketing service. Providers can also set spending caps, which would remove the Providers from the directory once a certain amount of booking fees has been met.

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Recently, in Advisory Opinion 22-20, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) approved an acute care hospital’s arrangement in which its employed nurse practitioners (NPs) perform certain services that the patients’ primary care physicians traditionally perform. This opinion may present opportunities for providers because it represents a departure from OIG’s typical approach to arrangements involving remuneration from a hospital to a referring physician and demonstrates OIG’s emphasis on healthcare providers offering quality care to federal healthcare program beneficiaries. However, it must be noted that this opinion’s efficacy is limited only to the federal Anti-Kickback Statute. Other laws, such as the federal physician self-referral law or Stark Law, may pose significant risk factors to similar arrangements. Also, Advisory Opinions are only binding on OIG in regarding the specific arrangements review, but they can be a source of guidance regarding other arrangements.

Under the proposed arrangement, the Requestor is an acute care hospital that provides inpatient and outpatient hospital-based services and which seeks to use its employed NPs to perform various tasks for the patients, who are inpatients or in observation status in two designated medical units and who are admitted by physicians that participate in the Requestor’s program. Participating physicians are predominantly primary care physicians, although the hospital makes the services available for all physicians who regularly admit patients to the designated medical units. The hospital does not take into account a physician’s volume or value of referrals in considering the physician for participation.

The arrangement is limited to two general care units and does not extend to surgical or specialty care units. Under the arrangement, the NPs perform various tasks in communication and collaboration with the physicians that the physicians would normally perform. Such tasks include initiating plans of care, educating patients and families, and arranging for follow-up laboratory or imaging studies, among others. The patients seen by the NPs are under active evaluation and require ongoing medical attention, thus the arrangement allows them to be diagnosed and treated more quickly. The treating physicians remain ultimately responsible for the patients’ care and must still round on their patients daily. The physicians also cannot bill for the NPs’ services. The hospital neither makes payments to the treating physicians under the arrangement nor separately bills any payor for the NPs’ services.

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The Office of Inspector General (OIG) for the United State Department of Health and Human Services (HHS) recently released a template to assist with preparing advisory opinion requests. This template can be used to ensure that requestors include the information required for the advisory opinion process. The template lays out the basic information required for an advisory opinion request and leaves an optional section for legal analysis. Although providing a legal analysis is not required, most requests include significant legal analysis regarding why OIG should approve the arrangement and it is often the most detailed and insightful portion of a successful advisory opinion request.

Advisory opinions issued by HHS OIG are legal opinions that are issued to the requesting parties that apply OIG’s fraud and abuse authorities to the requesting parties’ current or proposed business arrangement. Since the advisory opinion is tailored to and binding on a requesting party’s current or proposed business arrangement, OIG will not advise on any hypothetical or other arrangements that the party does not actually intend to engage in. Although most advisory opinion requests seek guidance regarding the Anti-Kickback Statute (AKS) and its safe harbors, OIG is also authorized to issue advisory opinions on the application of exclusion authorities, civil monetary penalty authorities, and criminal penalties.

OIG also declines to issue opinions on general questions of interpretation, the fair market value of goods, services, or property, or the application of the Stark law or the Eliminating Kickbacks in Recovery Act (EKRA). Although advisory opinions can provide valuable guidance, requesting an advisory opinion is a completely voluntary process. Accordingly, failure to seek an advisory opinion regarding a business arrangement cannot be introduced as evidence as proof that the party violated the law.

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued OIG Advisory Opinion No. 22-14 that applied its November 2020 special fraud alert targeting remuneration associated with speaking arrangements funded by pharmaceutical and medical device companies.

The November 2020 special fraud alert addressed potential Anti-Kickback Statute (AKS) risks arising from paying physicians to speak at educational programs and providing benefits to  attendees. OIG outlined several factors that, if present, would increase the risk of an AKS violation.

OIG’s No. 22-14 Advisory Opinion was issued in response to an ophthalmology practice’s proposed continued education program. The practice intended to offer continued education programs to local optometrists, who may be responsible for referring approximately half of the practice’s surgical patients. Although many of the local optometrists refer their patients to the practice, the program would be available to all optometrists in the area, and there would be no obligation to refer patients to the practice after attending the program.

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On July 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a special fraud alert targeting remuneration paid to physicians and other practitioners by telemedicine companies. As telemedicine use has increased exponentially over the last two years, so too have the proliferation of telemedicine marketing arrangements and the prosecution of these arrangements by OIG and federal law enforcement. OIG issued the fraud alert in conjunction with the announcement of a new $1.2 billion enforcement action regarding alleged telemedicine fraud.

Generally, the arrangements at issue involve a telemedicine company that may recruit both patients and physicians (or other practitioners). The telemedicine company then pays the physician to review some form of medical record, possibly contact the patient, and order some product or service, generally durable medical equipment (DME) or laboratory testing. OIG has taken the position that the fees paid to physicians and practitioners under these arrangements may constitute unlawful “remuneration” meant to induce or reward referrals under the Anti-Kickback Statute (AKS). Pursuant to the AKS, it is unlawful to knowingly and willfully solicit, receive, offer, or pay any remuneration to induce or reward, among other things, referrals for, or orders of, items or services reimbursable by a federal health care program.

OIG drafted the alert as a notice to physicians and other practitioners to be wary of certain characteristics in these arrangements. OIG outlined several ‘suspect characteristics’ that it believes may increase the risk of fraud and abuse in telemedicine arrangements:

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This spring, the Department of Justice (DOJ) intervened in a two-year-old qui tam whistleblower lawsuit against a hospital and oncology practice in Memphis, Tennessee. DOJ accused the hospital of violating the Anti-Kickback Statute (AKS) and the False Claims Act (FCA) by paying the oncology practice for its patient referrals. The hospital and the practice have maintained that the complex series of contracts between them represented a lawful business relationship meant to create a new cancer treatment center.

The AKS is a criminal statute that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs. Remuneration goes beyond cash payments and includes anything of value. If the AKS applies, conduct may still be lawful if it falls into one of several “safe harbors.” Some of the most common safe harbors are the investment interest safe harbor, specific types of rental agreements for office space or equipment, and contracts for personal services that meet certain criteria. The AKS is often enforced in conjunction with the FCA, which imposes civil liability for knowingly submitting false claims to the government. Importantly, the FCA carries severe consequences, including treble damages and a per-claim penalty that increases each year with inflation ($12,537 per claim for 2022).

In this case, the arrangement between the hospital and practice involved several distinct agreements. First, the hospital purchased many of the assets of the practice, including offices and equipment. Second, the hospital leased approximately 200 physician and non-physician employees from the practice. These first two agreements were supported by fair market value (FMV) opinions. Third, the hospital paid the physicians for management services under a Management Services Agreement (MSA). Lastly, the hospital made a several-million-dollar investment in a for-profit research entity controlled by the practice’s owners.

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Late last year, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a significant Advisory Opinion regarding a proposed joint venture (JV) between a therapy services provider and an owner of various long-term care (LTC) facilities. OIG concluded that it viewed the Proposed Arrangement as presenting a significant risk of fraud and abuse and potentially designed to permit the therapy services provider to pay the LTC owner a share of the profits derived from referrals for therapy services made by the LTC owner’s facilities. The opinion reiterates OIG’s longstanding concern that joint ventures formed between healthcare providers or suppliers and referral sources can present risk under the Anti-Kickback Statute (AKS).

Under the Proposed Arrangement, a therapy services provider would form a JV with an owner of LTC facilities where the JV would provide therapy services to the LTC facilities. The JV would contract out the bulk of operations (all clinical and non-clinical employees, space, and equipment) to the therapy services provider in exchange for a fair market value fee. The LTC owner would hold a 40% interest in the JV and the therapy services provider would hold the remaining 60% interest. The LTC owner’s investment in the JV would be based, at least in part, on the JV’s expected business from the LTC owner’s facilities. The LTC owner’s facilities were not required to contract with the JV or otherwise make or direct referrals to the JV, although the therapy services provider certified that it expected the LTC owner’s facilities to do so, and during the initial phases of the JV all of the JV’s revenues would be generated by services provided to the LTC owner’s facilities.

OIG concluded that the Proposed Arrangement would not satisfy any AKS safe harbors, including the small entity investment safe harbor, because the Arrangement likely violates the investor test, the revenue test, and the investment offer test. Moreover, OIG referred to its landmark 2003 Special Advisory Bulletin on Contractual Joint Ventures, which includes a detailed list of characteristics that OIG considers suspect when present under a contractual JV. Since the JV described in the Proposed Arrangement included several of these previously outlined suspect characteristics, OIG further determined that the proposed JV presents significant risk of fraud and abuse. This Advisory Opinion serves as a useful reminder of the regulatory framework applicable to joint ventures between healthcare providers and entities in a position to refer or generate business for the joint venture. Providers considering joint ventures should ensure that they are structured to comply with AKS and OIG guidance.

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