Targets, Theories, and Themes in Criminal Enforcement Actions
The takedowns and enforcement activity over the last several years highlight some common targets, theories, and themes in genetic testing fraud cases. The usual targets are (1) marketing companies (usually telemarketing, but some have also included elements of door-to-door marketing, Internet marketing, and direct marketing at community events and health fairs); (2) telemedicine company owners and their physicians; and (3) laboratory owners.
Theories of liability almost always are based on lack of medical necessity, transactions tainted by kickbacks, or both. And the specific offenses charged are likewise fairly consistent, including health care fraud (18 U.S.C. § 1347); conspiracy to commit health care fraud (18 U.S.C. § 1349); offering, receiving, or paying kickbacks (42 U.S.C. § 1320a-7b); and conspiracy to pay or receive kickbacks (18 U.S.C. § 371).
The alleged schemes usually share many of the same characteristics, typically alleging (1) aggressive marketing tactics to recruit Medicare beneficiaries to agree to genetic tests; (2) using telemedicine physicians to prescribe the genetic tests without seeing the patient or with little to no interaction with the patient; and (3) laboratories paying illegal kickbacks to the marketers and telemedicine companies/physicians to recruit the patients. A recent Southern District of Florida case, United States v. Omar Saleh, Case No. 1:22-cr-20317 (S.D. Fla. July 15, 2022), illustrates these common patterns.
Dr. Omar Saleh was charged on July 15, 2022, with conspiracy to commit health care fraud (18 U.S.C. § 1349), along with alleged co-conspirators Panda Conservation Group, LLC (owner of multiple laboratories and a marketing call center), and Michael Stein (an individual who solicited telemedicine physicians to order genetic tests for Medicare beneficiaries).
The government alleged that Saleh caused the submission of false and fraudulent claims for CGx and cardiovascular genetic testing that were “(a) procured through illegal kickbacks and bribes, (b) medically unnecessary, (c) ineligible for reimbursement, and (d) not provided as represented.” (Id.) Specifically, the government alleged that Saleh’s “[c]o-conspirators obtained access to thousands of Medicare beneficiaries’ insurance information and DNA material by causing them to be targeted with deceptive marketing campaigns, including online advertising and telemarketing, that promoted genetic testing.” (Id.) Stein then paid Saleh kickbacks to write genetic tests for Panda; Saleh ordered these genetic tests for patients with whom he had no prior relationship and whom he was not treating for any medical condition, and he did not use the test results for the treatment of the beneficiaries. To support its theories of liability, the government relied on 42 U.S.C. § 1395y(a)(1)(A), which states that Medicare does not cover diagnostic testing that is “not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” It also relied on 42 C.F.R. § 410.32(a), which provides,
all diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. . . . Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary.
Civil Enforcement Actions
The government has also addressed alleged misconduct involving genetic testing via civil enforcement. As usual, the government has primarily used the FCA in such matters. As in the criminal context, most civil actions involve allegations of (1) ordering medically unnecessary genetic tests and (2) inducing health care providers to give referrals through illegal kickbacks. (While the Anti-Kickback Statute (AKS) is a criminal statute, the government often uses alleged AKS violations to establish civil liability under the FCA and the Civil Monetary Penalties Law. (See 42 U.S.C. § 1320a-7b(g) (providing that “a claim that includes items or services resulting from a violation of the [AKS] constitutes a false or fraudulent claim” under the FCA); 42 U.S.C. § 1320a-7a(a)(1) (providing that it is a violation of the Civil Monetary Penalties Law to present a claim to the government “for a medical or other item or service . . . [when] the person knows or should know the claim is false or fraudulent.”).)
For example, in February 2019, a Canadian laboratory, GenomeDx Biosciences Corp., entered a $1.99 million settlement with the Department of Justice to resolve FCA allegations that it was billing Medicare for medically unnecessary CGx tests. (Press Release, U.S. Dep’t of Just., Genetic Testing Company Agrees to Pay $1.99 Million to Resolve Allegations of False Claims to Medicare for Medically Unnecessary Tests (Feb. 11, 2019).) The CGx tests at issue were for prostate cancer patients who “did not have risk factors necessitating” the CGx tests. (Id.)
In October 2019, another laboratory, UTC Laboratories, Inc., agreed to pay $42.6 million to resolve allegations that it was paying illegal kickbacks and submitted claims for medically unnecessary pharmacogenetic (PGx) testing. (Press Release, U.S. Dep’t of Just., Genetic Testing Company and Three Principals Agree to Pay $42.6 Million to Resolve Kickback and Medical Necessity Claims (Oct. 9, 2019).) While CGx involves genetic testing specifically related to cancer predisposition, PGx tests are administered to determine how a patient’s genetic makeup may affect his or her response to certain medications. (Pharmacogenomics in Patient Care, Mayo Clinic (last visited Feb. 16, 2023).) The illegal kickbacks at issue were twofold: (1) UTC paid kickbacks to physicians to order PGx tests “in return for their participation in a clinical trial known as Diagnosing Adverse Drug Reactions Registry” (Press Release, U.S. Dep’t of Just. (Oct. 9, 2019), supra); and (2) UTC paid kickbacks to entities and individuals for referrals of medically unnecessary PGx tests. As a part of the settlement, UTC Laboratories agreed to a 25-year exclusionary period from participating in any federal health care program.
More recently, in January 2022, UC San Diego Health agreed to pay the Department of Justice close to $3 million to resolve allegations that it ordered and submitted referrals for medically unnecessary genetic tests performed by CQuentia Labs and paid by Medicare in violation of the FCA, the Civil Monetary Penalties Law, and the Program Fraud Civil Remedies Act. (See Press Release, U.S. Dep’t of Just., UC San Diego Health Pays $2.98 Million to Resolve Allegations of Ordering Unnecessary Genetic Testing (Jan. 11, 2022); UC San Diego Health and U.S. Dep’t of Just. Settlement Agreement (Nov. 23, 2021).) Specific details related to why the government believed the tests were medically unnecessary were not provided in the Department of Justice’s announcement or the parties’ settlement agreement. However, a statement by UC San Diego Health asserted the false claims were a result of issues related to one of its “technology providers” and “order[ing] tests from a company that then allegedly made false claims about those orders.” (Kristina Davis, UC San Diego Health Pays $2.98M Settlement Over Claims of Unnecessary Genetic Testing, San Diego Tribune (Jan. 11, 2022).)
Practical Takeaways
Given the government’s robust enforcement to date, businesses, providers, and other stakeholders who work with CGx, PGx, and related testing or laboratory work need to be on guard. While risks cannot be completely avoided, several basic steps can help companies and individuals minimize those risks, including:
- Scrutinize contractual arrangements with business associates and marketers to ensure compliance with the AKS and the Civil Monetary Penalties Law. These laws are nuanced and, often, not intuitive.
- Ensure that any genetic tests ordered are (1) by a physician with an established physician-patient relationship, (2) medically necessary, and (3) properly reimbursable. Medical necessity should be well-documented within patients’ records.
- If telehealth services are utilized, stay current on the evolving reimbursement rules for telemedicine and ensure the underlying requirements for appropriately billing such tests are met.
- Regularly audit for potential outliers to assess for noncompliance.
- Consult with experienced counsel for compliance issues, preferably at the outset of a new venture, but especially if government scrutiny is suspected.