On
October 3, 2014, the Department of Health and Human Services, Office of
Inspector General (“OIG”) published a proposed rule amending the safe harbors to the
anti-kickback statute (“AKS”) and the civil monetary penalty (“CMP”) rules. The AKS, authorizes penalties of up to five years in jail and $25,000 in fines, for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce or reward the referral for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce or reward the referral of business reimbursable under Federal health care programs. However, the statute and current regulations provide safe harbors that protect certain arrangements that might otherwise implicate the AKS, from penalty. The proposed rule adds the following safe harbors:
- pharmacy waivers of cost-sharing for financially needy
Medicare Part D beneficiaries;
- waivers of cost-sharing for emergency ambulance
services furnished by State- or municipality-owned ambulance services;
- certain remuneration between Medicare Advantage
organizations and federally qualified health centers (“FQHCs”);
- discounts by manufacturers on drugs furnished to
beneficiaries under the Medicare; Coverage Gap Discount Program; and
- certain free or discounted local transportation services.
The proposed rule revises the
definition of “remuneration” in the CMP regulations, adding the following
statutory exceptions, which will allow these listed patient inducements to
circumvent triggering a CMP:
- copayment reductions for certain hospital outpatient
department services;
- certain remuneration that poses a low risk of harm and
promotes access to care;
- coupons, rebates, or other retailer reward programs
that meet specified requirements;
- certain remuneration to financially needy individuals;
and
- copayment waivers for the first fill of general drugs.
The proposed rule also codifies a
gainsharing CMP provision as set forth in Social Security Act 1128A(b).
Comments on the proposed rule may be
submitted until December 2, 2014, after which the OIG will review the comments,
revise the rule as necessary and publish a final rule.
Should you wish additional information or if you
have questions regarding this article, please do not hesitate to contact Meghan McNab at 317.808.5863 or Susan Ziel at 612.564.1927.