the Anti-Kickback Statute, and the U.S. Department of Justice (DOJ) has an active history of enforcement actions involving such referral schemes. Even under facts where these schemes may have at one point been permissible, the plain language of EKRA now prohibits this practice.In contrast, in-office laboratories generally only test specimens that are provided by the medical practice in which they are located. As such, EKRA may not be on their immediate radar. Therefore, legal counsel should ensure providers with in-office laboratories are aware of EKRA, as recent enforcement actions, testing trends during the COVID-19 pandemic, and a plain reading of the statute suggests in-office laboratories are also subject to the statute's prohibitions.What EKRA Covers:Unlike many federal fraud and abuse statutes, EKRA's prohibitions are applicable to services covered by any "health care benefit program," including those offered by private payors. The statute expressly adopts this definition from 18 U.S.C. § 24(b), and covers "any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract." Therefore, EKRA's reach is broader than the Anti-Kickback Statute and Stark Law, which only govern federal health care programs like Medicare and Medicaid. EKRA's reach also extends beyond large-scale laboratory operations. EKRA derives its definition of "laboratory" directly from 42 U.S.C. § 263a, which defines the term "laboratory" or "clinical laboratory" as "a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of,

Not to diminish the importance of complying with the law in these areas, but because the FDC Act’s prohibited act section covers almost all aspects of regulatory authority vested in FDA, prosecutors may well argue to courts if the proposed amendments are adopted that sentencing for a vast number of FDCA violations must be calculated under the “fraud” guidelines when in fact no fraud is involved, and even, potentially, when there is no direct impact on government health care programs.The Commission appears to be well-meaning enough by proposing to amend the definition of “federal health care offense” in section 2B1.1 of the Sentencing Guidelines (the “fraud” guidelines) to have the same meaning as in 18 U.S.C. § 24. Indeed, it proposes to amend that definition because the PPACA amended 18 U.S.C. § 24 to include FDC Act “prohibited acts” under 21 U.S.C. § 331. But without carving out from this section the FDC Act “prohibited acts” that do not involve fraud, the Commission could be inviting courts to impose greater sentences for FDC Act crimes that have nothing to do with fraud.

13See 18 U.S.C. § 220(a) & (e); 42 U.S.C. § 263a.14 18 U.S.C. § 24(b). Importantly, however, EKRA states that it “does not apply to conduct that is prohibited” by the AKS. 18 U.S.C. § 220(d).

While the Anti-Kickback Statute applies to federally-reimbursed funds and the Stark Law is specific to Medicare and Medicaid, the EKRA encompasses all services that are, “covered by a health care benefit program.”Under 18 U.S.C. Section 24(b), a “health care benefit program is defined as, “any public or private plan or contract . . . under which any medical benefit, item, or service is provided to any individual . . . .” Thus, the EKRA applies not only to remuneration paid in connection with referrals of federal health care benefit program beneficiaries, but to remuneration paid in connection with patients who have private health insurance coverage as well.4.

18 U.S.C. §§ 1347, 1349. The VA is a “health care benefit program,” 18 U.S.C. § 24(b), and the Anti-Kickback Statute provides stiff penalties, including fines and prison time, for fraud involving “federal health care programs” like the VA, see 42 U.S.C. § 1320a-7b. Civil fines under the Anti-Kickback Statute also can be imposed per violation, potentially exposing organizations to millions of dollars in liability.

That is likely true. But until further clarification is issued, anyone potentially affected by the law should review his/her business arrangements and consult with regulatory and compliance counsel without delay.1 EKRA refers to the statutory definition of health care benefit program found at 18 U.S.C. § 24. That statute defines a “health care benefit program” as “any public or private plan or contract, affecting commerce, under which any medical benefit, item or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item or service for which payment may be made under the plan or contract.”

This incorporates the definition of “laboratory” in 42 U.S.C. 263a(a).[9] EKRA applies to services covered by a “health care benefit program,” which is defined as having its meaning under 18 U.S.C. 24(b): “any public or private plan . . . under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.”[10] For a full list of AKS safe harbors, see 42 C.F.R. 1001.

18 U.S.C § 220(e)(4). [6] 18 U.S.C. § 24(b). [7] The Commerce Clause of the United States Constitution authorizes Congress to regulate commercial activity “with foreign Nations, and among the several States, and with the Indian Tribes.” U.S. Const. Art. I, Sec. 8, cl. 3. [8] 42 U.S.C. § 1320a-7b(b).

As referenced above, whereas the Federal AKS applies only to referral of patients who are covered by a “Federal Health Care Program,”[2] the Eliminating Kickbacks in Recovery Act extends its prohibitions to any and all health care benefit programs – defined by the Federal Criminal Code as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.” 18 U.S. Code § 24(b). In effect, the federal government can now police strictly private market arrangements for conflicts of interest (i.e., between private providers and commercial insurers).

As referenced above, whereas the Federal AKS applies only to referral of patients who are covered by a “Federal Health Care Program,”[2] the Eliminating Kickbacks in Recovery Act extends its prohibitions to any and all health care benefit programs – defined by the Federal Criminal Code as “any public or private plan or contract, affecting commerce, under which any medical benefit, item, or service is provided to any individual, and includes any individual or entity who is providing a medical benefit, item, or service for which payment may be made under the plan or contract.” 18 U.S. Code § 24(b). In effect, the federal government can now police strictly private market arrangements for conflicts of interest (i.e., between private providers and commercial insurers).