No administrative sanctions will be imposed by the Health and Human Services Office of Inspector General (OIG) for a proposed patient-assistance program that provides funds for insurance premiums and other medical treatments, according to Advisory Opinion No. 13-19, posted on the OIG Web site Dec. 2. While the opinion is not directly related to laboratories, it does provide information that can be used by a laboratory’s compliance officer to make decisions about financial assistance requests being sought for individual patients or as a mechanism to assess the risk associated with its programs for charitable donations and financial aid for uninsured patients. Laboratories, and other kinds of providers, are often asked whether they can provide financial aid to pay for tests or services for a patient who either has no insurance or whose insurance does not cover all of their medical expenses. The facts described in the opinion concerning this particular arrangement are not as important as the OIG’s legal analysis of the proposed arrangement. It is this analysis that can provide useful information about reducing compliance risks in a lab’s charitable contributions and financial aid policies. Just as the anti-kickback statute (AKS) prohibits inducements for referring practitioners, it also prohibits […]
No administrative sanctions will be imposed by the Health and Human Services Office of Inspector General (OIG) for a proposed patient-assistance program that provides funds for insurance premiums and other medical treatments, according to Advisory Opinion No. 13-19, posted on the OIG Web site Dec. 2.
While the opinion is not directly related to laboratories, it does provide information that can be used by a laboratory’s compliance officer to make decisions about financial assistance requests being sought for individual patients or as a mechanism to assess the risk associated with its programs for charitable donations and financial aid for uninsured patients.
Laboratories, and other kinds of providers, are often asked whether they can provide financial aid to pay for tests or services for a patient who either has no insurance or whose insurance does not cover all of their medical expenses. The facts described in the opinion concerning this particular arrangement are not as important as the OIG’s legal analysis of the proposed arrangement. It is this analysis that can provide useful information about reducing compliance risks in a lab’s charitable contributions and financial aid policies.
Just as the anti-kickback statute (AKS) prohibits inducements for referring practitioners, it also prohibits inducements for beneficiaries. The laboratory may not provide incentives directly to patients as a means of influencing their health care choices unless they meet the requirements of certain well defined exceptions under the self-referral (Stark) and AKS laws and regulations. The OIG points out the factors that reduce the risk of abuse in the proposed arrangement described in the advisory opinion, and it is this list of mitigating factors that resulted in a favorable opinion.
Objectivity and Distance
According to the opinion, “Long-standing OIG guidance makes clear that industry stakeholders can contribute to the health care safety net for financially needy patients, including beneficiaries of federal health care programs, by contributing to independent, bona fide charitable assistance programs.” Applying the principles expressed in the advisory opinion to a laboratory’s charitable donations or patient financial-assistance policies is a challenge but it can be worth the effort, especially in the environment of today’s laboratory market where government scrutiny is increasing and one genetic test can cost more than $2,000.
Donating to a program, such as the foundation described in the opinion, as opposed to donating directly to individual patients, helps provide some distance between the donating entity and the patient and as a result reduces the risk of linking one to the other. It is important to have some kind of autonomous entity, committee, or department that determines which patients receive a charitable donation or financial aid. The intervening committee would make all choices about recipients based on its own objective criteria but it should not make any attempt to influence patient choices.
One important aspect is to ensure that the sales and marketing or business development departments do not have any authority or oversight of the committee activities and funding for the committee is separate. Another factor to consider is that patients have no restrictions on where they receive their laboratory tests.
In assessing any patient financial aid program, the OIG should consider the totality of facts and circumstances of the program as expressed in policy and procedure and would consider any audit results of the program to ensure it meets policy and procedure requirements. A lab that incorporates the concepts described in this advisory opinion in its financial aid or charitable donation policies should have decreased risk of compliance problems with its programs.
Takeaway: Patient assistance programs can be allowed if structured properly. Compliance officers should review all advisory opinions from the Health and Human Services OIG, even those seemingly unrelated to laboratory services, because they often contain useful guidance for some aspect of their compliance program.
