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Application of Certain Fraud and Abuse Authorities to Certain Types of Arrangements

(1) A hospital would like to distribute, upon discharge, naloxone rescue kits to patients who present to its emergency department with an opioid overdose and are at risk for opioid overdose after leaving the hospital. Some of the patients who receive the naloxone rescue kits would be Federal health care program beneficiaries.

OIG recognizes that naloxone plays a critical role in saving the lives of those who abuse or misuse opioids, and the importance of readily available naloxone has been documented throughout HHS. For instance, the U.S. Surgeon General has issued an advisory discussing the importance of the availability of this medication in the context of the opioid epidemic:

Expanding the awareness and availability of this medication is a key part of the public health response to the opioid epidemic. Naloxone is a safe antidote to a suspected overdose and, when given in time, can save a life. Research shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities. Therefore, increasing the availability and targeted distribution of naloxone is a critical component of our efforts to reduce opioid-related overdose deaths and, when combined with the availability of effective treatment, to ending the opioid epidemic. [Office of the Surgeon General, U.S. Surgeon General’s Advisory on Naloxone and Opioid Overdose. Accessed at https://www.hhs.gov/surgeongeneral/reports-and-publications/addiction-and-substance-misuse/advisory-on-naloxone/index.html on Jan. 18, 2023.]

In addition, the Centers for Disease Control and Prevention recommends that individuals carry naloxone if they, or someone they know, are at increased risk for opioid overdose. [https://www.cdc.gov/stopoverdose/naloxone/index.html.]

Providing free items, including naloxone rescue kits, to patients who are Federal health care program beneficiaries implicates the Federal anti-kickback statute because the hospital would be offering something of value for free to Federal health care program beneficiaries, who could self-refer to the hospital for reimbursable items and services. The proposal also would implicate the Beneficiary Inducements CMP because the free naloxone rescue kits could reasonably influence a Medicare or State health care program enrollee to select the hospital for other items or services reimbursable by Medicare or a State health care program.

Nonetheless, in the context of a nationwide opioid epidemic, we believe the provision of naloxone rescue kits in the circumstances described in the question could present a sufficiently low risk of fraud and abuse and could save the lives of individuals who may suffer an opioid overdose. Various factors, if present, may decrease any risk of fraud and abuse under the statute, such as:

  • The hospital’s distribution of naloxone rescue kits complies with all other Federal and State laws governing such distribution.
  • The hospital has a written policy for the distribution of the naloxone rescue kits to patients at risk for opioid overdose and applies such policy uniformly to all patients who present to the emergency department.
  • The hospital does not advertise or market the availability of the free naloxone rescue kits to induce an enrollee to receive federally reimbursable items or services or to receive such items and services from the hospital.
  • The provision of the free naloxone rescue kits is not contingent on the enrollee’s selection of the hospital for any future items or services reimbursable by Federal health care programs.

(2) Can a plan provide remuneration to Dual Eligible Special Needs Plan (D-SNP) enrollees to compensate them for their time and expertise on the plan’s enrollee advisory committee?

By regulation, Medicare Advantage (MA) organizations offering one or more D-SNPs in a State must establish and maintain, for contract year 2023 and subsequent years, one or more enrollee advisory committees that serve the D-SNPs offered by the MA organization in that State. More specifically, the regulations require that the enrollee advisory committees include a reasonably representative sample of enrollees, or other individuals representing those enrollees, and that the MA organizations solicit input from the enrollee advisory committees on, among other topics, ways to improve access to covered services, coordination of services, and health equity for underserved populations.

Remuneration to a D-SNP enrollee for serving on the plan’s enrollee advisory committee likely would not implicate the Beneficiary Inducements CMP. The provision of anything of value to a D-SNP enrollee to participate on an enrollee advisory committee is remuneration to a Medicare enrollee. However, remuneration from a health plan for the purposes of compensating D-SNP enrollees for their work on the plan’s enrollee advisory committee is not likely to influence the enrollee’s selection of a particular provider, practitioner, or supplier for the order or receipt of any item or service for which payment may be made by Medicare or a State health care program. Furthermore, to the extent that the remuneration has the potential to influence an enrollee’s selection of a particular D-SNP, we note that a D-SNP is not a provider, practitioner, or supplier for purposes of the Beneficiary Inducements CMP.

However, this remuneration implicates the Federal anti-kickback statute because remuneration from the plan could induce D-SNP enrollees to enroll or re-enroll in the plan, which in turn arranges for the provision of federally reimbursable items and services. To ensure that a D-SNP can meet its regulatory obligations, a D-SNP’s provision of certain in-kind remuneration to enrollees who are advisory committee participants (e.g., refreshments, reasonable meals, travel reimbursement, transportation tokens, or gift cards other than cash equivalents) may be appropriate and sufficiently low risk under the Federal anti-kickback statute. Various factors, if present, may decrease the risk of fraud and abuse under the statute, such as:

  • The remuneration compensating D-SNP enrollees for their time and expertise on the plan’s enrollee advisory committee is of modest value and is proportionate to the value of the enrollees’ time and effort expended in serving on the plan’s advisory committee.
  • The plan uses a uniform selection process for committee participants that is based on factors unrelated to the enrollee’s health status (to avoid cherry picking).
  • The plan does not advertise any remuneration furnished in connection with participation on the plan’s enrollee advisory committee.

As a reminder, OIG has a longstanding view that providing cash and cash-equivalent remuneration to enrollees may raise substantial fraud and abuse risks.

Last updated March 22, 2023