On April 11, 2022, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) issued Advisory Opinion #22-06, finding that the sponsored genetic counseling and testing program by a pharmaceutical manufacturer posed a low risk of fraud and abuse, despite the involvement of federal anti-bribery law. This advisory is a welcome development for pharmaceutical manufacturers, as it provides the first insight into how the OIG might view sponsored testing programs that have become more prevalent with the advent of personalized medicine and a number growing number of targeted therapies. But the good news doesn’t come without an important caveat, as the OIG noted that if certain facts of the arrangement were different, the OIG would “likely come to a different conclusion.”
As always, the advisory opinion applies only to the specific arrangement being analyzed and does not bind the agency with respect to any other sponsored testing arrangement. Critically, the OIG advisory highlights the need for manufacturers to carefully consider the facts and safeguards applicable to any sponsored testing program.
The Products and Sponsored Testing Program
The applicant manufactures a drug approved for the treatment of a rare and serious disease, one form of which can affect the heart and lead to heart failure and death. The disease caused by the disorder can be inherited or occur spontaneously. The drug is approved to treat both versions of the disease and comes in two forms. According to the petitioner, diagnosis of the disease requires clinical evaluation including diagnostic tests, but patients are often not correctly diagnosed with the disease until years after its onset, which can lead to inadequate or incorrect treatment.
The majority of hereditary cases of the disease are caused by a specific genetic mutation that can be identified by genetic testing. About ten to twenty percent of patients who carry the mutation will develop the disease. Thus, although genetic testing cannot diagnose disease, it can provide information to help: (1) identify the form of disease a patient has, which may influence disease progression; (2) identify patients who could benefit from diagnostic testing for the disease; and (3) monitor asymptomatic patients at increased risk of developing disease.
Under the sponsored screening program, the applicant offers free genetic testing and counseling services to certain eligible individuals. Genetic testing is only for specific mutations associated with the disease. To be eligible to participate in the program, a person must: (1) be diagnosed with the disease; (2) being suspected by their doctor of having the disease; or (3) have a family member with a confirmed diagnosis of the hereditary form of the disease.
Any doctor can order the genetic test through the program for any eligible patient. Applicant has certified that it does not otherwise require or encourage physicians who order genetic testing through the Program to recommend, prescribe or administer products manufactured by Applicant.
Blood samples are collected at the prescribing physician’s office, similar practice setting, or associated laboratory. The applicant does not provide payment for sample collection, but it is possible that, in at least some circumstances, sample collection may be covered by a federal health care program or other payer.
Patients who undergo genetic testing under the program can also obtain free counseling services at the request of the prescribing physician. Some physicians who order a test under the program may choose to offer genetic counseling directly to their patients, which may be reimbursable in certain circumstances, but is not paid for by the applicant.
Applicant’s sales representatives distribute program materials and specimen collection kits to cardiologists that Applicant has identified as capable of diagnosing and treating patients with the disease. The requester limits the number of sample collection kits a sales representative can provide to an individual physician, although physicians can order additional sample collection kits directly from the test provider.
Applicant does not proactively provide program information to patients or potential patients. However, Applicant’s patient support program may reactively provide program information to a patient who has been prescribed medication for the illness. Additionally, the requester does not receive any data from test or counseling providers that includes individually identifiable health information or from the specific providers who ordered the tests. Applicant does not use test program data for any sales and marketing purposes, including targeting or incentivising.
OIG Approves Proposed Sponsored Testing Program But Points Out Limitations to Its Approval
The OIG said the program involves federal anti-bribery law because it results in compensation for patients and their physicians. On the patient side, the program offers free genetic testing and counseling services that the OIG has called “intrinsically valuable.” As far as physicians are concerned, the program offers the possibility of offering a free service to patients and possibly of charging for other ancillary services. However, the OIG found the program to be at low risk of fraud and abuse for several reasons.
First, taking into account the eligibility criteria and other safeguards, the OIG concluded that the program was unlikely to result in overuse or inappropriate use because the presence of genetic mutations does not, on its own, determine whether a patient has (or will develop) the disease and could benefit from the plaintiff’s drug. In addition to this attenuated link between testing and treatment decisions, the OIG relied on several other critical factors in reaching its conclusion:
there are no data to support the use of the drug in patients who have not been diagnosed with the disease;
it is not medically appropriate for a physician to prescribe the drug to patients who have not been diagnosed with the disease;
the plaintiff does not promote the drug to patients who have not been diagnosed with the disease; and
the claimant does not manufacture, market, promote or have any other financial interest in any other items or services used to treat or diagnose the disease.
Significantly, the OIG noted that it would likely come to a different conclusion if there was a more direct link between the free genetic test and the ordering or purchase of the manufacturer’s products.
In addition to the key facts above, the OIG noted that the program covers only one genetic test which has limited utility as an aid in the diagnosis of the specific disease at issue. The OIG found that “depending on the circumstances, free genetic tests that cover a wider range of genetic mutations may present a higher risk of overuse or inappropriate use.”
Secondthe OIG has found that the program is unlikely to distort clinical decision-making or raise concerns about patient safety or quality of care because the applicant does not encourage or otherwise require providers who order tests through the program recommend, prescribe or administer products manufactured by the applicant.
ThirdThe OIG has identified various safeguards that prevent the program from being used as a marketing or sales tool:
the applicant has certified that its sales representatives will not distribute specimen collection materials or kits in a manner that takes into account a physician’s use of the program or his or her history of prescribing the drug;
the applicant limits the number of kits a sales representative can provide to a particular physician; and
there are important limitations on the applicant’s receipt and use of data related to the sponsored testing program, including:
not to receive personally identifiable health information about patients or data identifying the providers who ordered the tests; and
not to use data from testing or consulting providers for sales targeting or incentives.
Questions remain for other test programs
While the OIG opinion recognizes the legitimacy of manufacturer-sponsored testing programs, as well as the limited accompanying genetic counseling for patients, the long list of facts and safeguards that informed the analysis of the agency can be used to limit their scope.
Perhaps most notably, the OIG reported that it likely would have reached a different conclusion if the program had a stronger link to the manufacturer’s product requirements, which could impact sponsored testing programs where the free test plays a bigger role in making a definitive diagnosis. This view is confusing, however, because in many cases a more definitive genetic test can rule out patients who are not suitable candidates for a particular therapy, helping to avoid overuse or inappropriate use of the drug. Hopefully the BIG caveats will not unduly restrict these types of beneficial testing programs.
Additionally, the OIG has expressed skepticism towards programs involving the provision of free genetic testing that cover a wider range of genetic mutations and programs that are used as a marketing tool or to target donor doctors. order for sales tracking messages.