OIG Proposes Amending the Safe Harbors to AKS and CMP Rules, Local Transportation Included
October 3, 2014
By: Louis C. Szura
Hospitals and providers may soon be able to offer a free ride to their patients so that they can make their appointments. Earlier today HHS/OIG issued proposed revisions to Safe Harbors under the Anti-Kickback Statute (AKS) and Civil Monetary Penalty (CMP) Rules. For the most part, the revisions seek to codify statutory changes set forth in recent laws (MMA, PPACA and ACA) into the AKS and CMP, but they would also add to the safe harbors as well. The proposed AKS safe harbor changes would include:
(a) A “technical” correction to the text of the existing safe harbor for referral services;
(b) Protection for pharmacy waivers of cost-sharing for certain Part D beneficiaries;
(c) Protection for waivers of cost-sharing for emergency ambulance services furnished by state-owned ambulance services;
(d) Protection for certain remuneration between Medicare Advantage organizations and FQHCs;
(e) Protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
(f) Protection for certain free or discounted local transportation services.
The proposed regulations also seek to amend the definition of “remuneration” in the CMP regulations by including exceptions for: (a) co-payment reductions for certain hospital outpatient department services; (b) remuneration that poses a low risk of harm and promotes access to care, (c) retailer rebate programs, (d) certain types of remuneration to financially needy individuals; and (e) waivers for co-payment for the first fill of generic drugs.
While many of these provisions are codifications of changes in other recent laws, the inclusion of a proposed new safe harbor for non-nominal “local transportation” has been discussed for some time. The new safe harbor would apply to free or discounted local transportation provided to federal health care beneficiaries, even if such services are not nominal in cost. The proposed rule includes limits on the type of providers that could provide local transportation service and the type of patients to whom such services could be provided (established patients only). The OIG is seeking comments on the rule and it raises numerous interesting questions, such as the context in which it should be allowed in the home health industry, the types of providers that might utilize the service, whether there should be any requirement to document a need for transportation, how the services could be marketed, and the distance considered to be “local” in urban and rural areas.
The OIG is seeking comments by December 2, 2014. (Full text of Proposed Rule: http://0-www.gpo.gov.librus.hccs.edu/fdsys/pkg/FR-2014-10-03/pdf/2014-23182.pdf)