On October 3, 2014, the Office of Inspector General (OIG) published a favorable proposed rule that would make changes to the anti-kickback and civil monetary penalties (CMP) regulations. This proposed rule clarifies previously issued guidance and provides insight on the OIG’s stance with respect to these laws. Set forth below are highlights of the proposed rule.

  • Free Transportation Safe Harbor. The OIG proposed to add a new regulatory safe harbor to the anti-kickback statute that would protect free or discounted local transportation made available to established patients to obtain medically necessary items and services. This could allow, for example, a physician in an oncology practice to offer local transportation to a patient who has attended at least one appointment and who might have trouble reliably attending future appointments for chemotherapy.
  • Exceptions to Beneficiary Inducement CMP. The OIG proposed to add exceptions to the definition of “remuneration” in the beneficiary inducement CMP regulations to allow certain arrangements that benefit patient care.
    • One exception would protect remuneration that “promotes access to care and poses a low risk of harm to patients and Federal health care programs.” The addition of this exception to the regulations would implement one of the statutory exceptions added to the definition of “remuneration” by the Patient Protection and Affordable Care Act. As an example of this exception, a hospital could provide lodging assistance to patients and their families when the assistance is necessary for the patient to obtain appropriate care.
    • Another exception would protect the offer or transfer of items or services for free or less than fair market value after a determination that the recipient is in financial need and meets certain other criteria. As an example of this exception, a physician could provide an air conditioner to an asthmatic patient if the physician makes an individualized determination that such patient is in financial need.
  • Gainsharing CMP. In light of changes to the practice of medicine over the years, the OIG is considering a narrower interpretation of the term “reduce or limit services” as used in the gainsharing CMP statute. The OIG seeks comments on how to “interpret the statutory prohibition broadly enough to protect beneficiaries and Federal health care programs, but narrowly enough to allow low risk programs that further the goal of delivering high quality health care at a lower cost.” This change could allow, for example, a hospital to offer physicians the opportunity to share in cost savings realized by a standardization of medical devices program so long as the program does not “reduce or limit services” to patients.

The proposed rule can be accessed here.