Health Center Regulatory Issues

OIG Issues Proposed Rule that Revises Safe Harbors under the Anti-Kickback Statute and Amends Regulatory Exceptions Related to Beneficiary Inducements

The OIG has issued a notice of proposed rulemaking (NPRM) that would revise the Medicare and Medicaid safe harbors under the anti-kickback statute and amend the civil monetary penalty rules pertaining to beneficiary inducement and gainsharing.  Among the revisions to the existing safe harbors to the Anti-Kickback Statute, the OIG intends to codify protection for certain cost-sharing waivers related to pharmacy services provided to financially needy Medicare Part D beneficiaries, protection for remuneration between Medicare Advantage organizations and FQHCs, and protection for free or discounted local transportation services that meet specified criteria.

In addition, the OIG would amend the definition of “remuneration” in the Civil Monetary Penalties (CMP) regulations related to the prohibition against patient inducements/incentives, promulgating the implementing regulations for the new exceptions to remuneration codified in the Affordable Care Act.  Among the changes, the OIG would extend protection to certain remuneration (i.e., patient incentives and inducements) that promotes access to care and poses a low risk of harm to patients and to federal health care programs, and to certain remuneration to financially needy individuals.  The OIG proposes to define “promotes access to care” as remuneration that improves a beneficiary’s ability to access medically necessary health care items and services (thus indicating that the remuneration must have a direct connection with access to care).  The OIG is considering expanding this definition to include remuneration that has an indirect connection by encouraging, supporting and/or assisting patients in accessing care, or making access to care more convenient for patients.  In this regard, the OIG has requested specific examples of remuneration to beneficiaries that would promote access to care under the broader definition while posing low risk of harm to Medicare and Medicaid beneficiaries and programs.

NACHC intends to comment on the NPRM as it provides FQHCs with an additional legal basis to waive cost-sharing obligations, accept donations from Medicare Advantage organizations, provide free or discounted local transportation services, and provide certain incentives to patients that would otherwise create exposures under either the Anti-Kickback Statute or CMP regulations related to the prohibition against beneficiary inducements.  Comments are due by December 2, 2014 at 5 pm EST.