On December 7, 2016, the HHS Office of Inspector General published the long-awaited final rule (the Rule) amending the safe harbors under the Anti-Kickback Statute and the civil monetary penalty (CMP) rules under the Affordable Care Act (ACA). The rule changes become effective on January 6, 2017.

The new and revised safe harbors protect certain payment practices and business arrangements from sanction under the Anti-Kickback Statute. The rule changes are designed to “promote access, quality, patient choice, appropriate utilization, and competition while protecting against increased costs, inappropriate steering of patients, and harms associated with inappropriate incentives tied to referrals.”  Among the services covered by the Rule are:

Pharmacy waivers of cost-sharing for financially-needy beneficiaries; Arrangements to provide free or discounted local transportation to patients; Cost-sharing waivers for emergency state or municipality-owned ambulance services; Protection for certain payments between Medicare Advantage organizations and federally qualified health centers; and Protection for discounts furnished by drug manufacturers to beneficiaries under the Medicare Coverage Gap Discount program.

However, with the good comes the bad, and while the Rule offers expanded safe harbors, it also grants enlarged civil monetary penalty authority.  The Rule allows for civil monetary penalties, assessments and exclusion for failing to provide timely access to records, ordering or prescribing while excluded, making false statements, omissions or misrepresentations in an enrollment application, failing to report and/or return an overpayment, and making or using a false record or statement that is material to a false or fraudulent claim.

Healthcare providers and pharmacies, while given new latitude for certain remuneration practices and the provision of some free or discounted services under the expanded safe harbor exclusions, should not become complacent. Appropriate compliance programs should be actively maintained and effectively implemented in order to stand ready for any government inquiries or investigations.