The HHS Office of Inspector General has published notice of a proposed rule which (if adopted) would modify some of the existing safe harbors to the anti-kickback statue, and add new safe harbors (including a long-awaited safe harbor for free or discounted local transportation services).  The proposed rule would also codify civil monetary provisions for gainsharing and would amend the definition of “remuneration” in the existing civil monetary penalty regulations to provide for additional exceptions.

The proposed rule:

• Makes a technical correction to the existing safe harbor for referral services.

• Proposes the addition of a new safe harbor for certain cost sharing waivers, including:

(i)        pharmacy waivers of cost-sharing for financially needy
Medicare Part D beneficiaries; and

(ii)       waivers of cost-sharing for emergency ambulance services
furnished by State or municipality-owned ambulance services.

• Proposes the addition of a new safe harbor for certain remuneration between Medicare Advantage plans and FQHCs.

• Proposes the addition of a new safe harbor for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program.

• Proposes the addition of a new safe harbor for free or discounted local transportation services to established patients for the purpose of obtaining medically necessary items or services and which  meet specified criteria.

• Would exclude the following from the definition of “remuneration” under the civil monetary penalty law:

(i)        copayment reductions for certain hospital outpatient
department services;

(ii)       certain remuneration that poses a low risk of harm and
promotes access to care;

(iii)      coupons, rebates, or other retailer reward programs that meet
specified requirements;

(iv)      certain remuneration provided to financially needy individuals;
and

(v)       copayment waivers for the first fill of generic drugs.

• Codification of the gainsharing civil monetary penalty rule.

Some of the proposed rule originates from statutory changes set forth in the Affordable Care Act and the Medicare Prescription Drug, Improvement and Modernization Act of 2003. Others go back even farther.  The OIG initially announced that public comments would be solicited regarding the provision of free and discounted local transportation services in an August 2002 Special Advisory Bulletin entitled “Offering Gifts and other Financial Inducements to Beneficiaries”.  Public comments regarding the proposed rule will be accepted 60 days from the publication of the proposed rule in the Federal Register.