The Anti-Kickback Statute

The Anti-Kickback Statute criminalizes offering or receiving remuneration (defined as anything of value) in exchange for referring or generating federal healthcare business. Each violation can be punished by up to a $100,000 fine (up from $25,000 before 2018), 10 years in prison (up from 5 years before 2018), or both. Needless to say, these penalties are extremely harsh—especially considering the conduct it criminalizes is perfectly legal in almost every other industry except healthcare. Indeed, the government itself warns in its Roadmap for New Physicians that:  “In some industries, it is acceptable to reward those who refer business to you. However, in the Federal health care programs, paying for referrals is a crime.”

Although “rewarding referrals” may sound easy enough to understand, the AKS is so broad and ambiguous that no single condensed statement can capture all the conduct it criminalizes.  One federal court judge has famously described this statute as a “meat axe.”  U.S. v. Anderson, 85 F. Supp. 2d 1047 (D. Kan. 1999).

The AKS, found at 42 U.S. Code § 1320a–7b(b), provides:

(b)Illegal remunerations

(1) Whoever knowingly and willfully solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind—

(A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or
(B) in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program,

shall be guilty of a felony and upon conviction thereof, shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.

(2) Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person—

(A) to refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program, or
(B) to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program,

shall be guilty of a felony and upon conviction thereof, shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.

Recognizing that AKS criminalizes a broad swath of conduct and is difficult to interpret, Congress authorized the Department of Health and Human Services to create “safe harbors.”  These safe harbors spell out ways in which you can structure your transaction to avoid AKS liability.  Many of the safe harbor structures would technically violate the AKS—but for the regulation’s explicit promise that the “practices shall not treated as a criminal offense.”

WLEK Safe Harbor

There are currently 25 regulatory safe harbors, found at 42 CFR § 1001.952, that may apply to transactions involving:

A.  Investment Interests
B.  Space Rental
C.  Equipment rental
D.  Personal services and management contracts
E.  Sale of practice
F.  Referral services
G.  Warranties
H.  Discounts
I.  Employees
J.  Group purchasing organizations
K.  Waiver of beneficiary coinsurance and deductible amounts
L.  Increased coverage, reduced cost-sharing amounts, or reduced premium amounts offered by health plans
M.  Price reductions offered to health plans

N.  Practitioner recruitment
O.  Obstetrical malpractice insurance subsidies
P.  Investments in group practices
Q.  Cooperative hospital service organizations
R.  Ambulatory surgical centers
S.  Referral agreements for specialty services
T.  Price reductions offered to eligible managed care organizations
U.  Price reductions offered by contractors with substantial financial risk to managed care organizations
V.  Ambulance replenishing
W.  Health centers
X.  Electronic prescribing items and services
Y.  Electronic health records items and services

Each safe harbor comes with its own stringent set of requirements, every one of which must be met in order to qualify for protection.

We can help evaluate your transactions and circumstances to determine your risk under the AKS and whether a safe harbor may apply.  We can also assist in structuring your remunerative scheme so that it falls within a safe harbor.

If the federal government has already initiated an investigation, served you with a subpoena, or executed a search warrant, you may want to consider asserting your constitutional rights.  We can help you evaluate whether to assert these rights, whether to cooperate with the government and reach a negotiated settlement, or whether to fight the charges all the way through trial. Give us a call at 703-591-9700.

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