Proposed Revisions to the AKS and CMP Regulations

By Adrienne Dresevic, Esq., and Leslie A. Rojas, Esq.

On October 3, 2014, the OIG published a proposed rule, 79 FR 59717, to amend the safe harbors under the Anti-Kickback Statute (AKS), as well as to revise the definition of “remuneration” and add a gainsharing provision under the Civil Monetary Penalties (CMP) regulations. Included in the recommended changes is the OIG’s proposal to add AKS protection for certain free or discounted local transportation services.

AKS Protection for Certain Free or Discounted Local Transportation Services

One of the major provisions of the proposed rule is new protection for free or discounted local transportation services provided to federal health care program beneficiaries as long as specific requirements are met. Currently, section 1128A(a)(5) of the Social Security Act is not intended to preclude the provision of complimentary local transportation of nominal value. “Nominal value” means “no more than $10 per item or service or $50 in the aggregate over the course of a year.” However, the OIG is concerned that this definition is overly restrictive. The proposed safe harbor would protect not only certain free transportation but also certain discounted transportation.

First, the safe harbor only protects transportation services provided to the patient (and, if necessary, someone to assist the patient) to obtain medically necessary items or services within the local area (25 miles) of the health care provider or supplier. The proposed safe harbor does not apply to laboratories or to individuals and entities that primarily supply health care items, such as DME suppliers. The OIG is soliciting comments on what other providers and suppliers should be excluded from protection under this safe harbor. For example, the OIG is concerned that the protection of free or discounted transportation by home health care providers to physician offices may result in unnecessary physician visits or serve as an inducement to physicians to refer to the home health care provider.

Additionally, the safe harbor is only available for the transportation of established patients. This restriction is intended to reduce the risk that a provider or supplier could use the safe harbor to inappropriately induce referrals of new patients from other providers. Similarly, the provider or supplier is not afforded protection under the safe harbor if: (i) the transportation is made available only to patients who were referred by a particular referral source; or (ii) the transportation is contingent on a patient seeing a particular provider or supplier who may be a referral source. Further, under the proposed rule, while a provider or supplier may restrict the offer of free or discounted transportation to patients whose conditions require frequent or critical appointments, they may not restrict the offer to patients receiving expensive treatments that are lucrative for the provider or supplier offering the transportation.

Additional exclusions from protection under the safe harbor include: transportation by air, luxury (eg, limousine), or ambulance-level transportation; transportation involving payment on a per-beneficiary basis (as opposed to an hourly or mileage basis); transportation services that are publicly advertised to patients or potential referral sources; and transportation that includes the marketing of health care items and services during the transportation (not including signage on the vehicle designating the source of the transportation). Lastly, the OIG is soliciting comments on whether it should require providers and suppliers to document beneficiary eligibility criteria, such as a need for free or discounted transportation, and whether the protection should apply to transportation for non-medical care that relates to the patient’s health care (eg, counseling or social services).

Additional Proposed Revisions to the AKS Regulations

The OIG proposes further revisions to the AKS regulations, including:

a technical revision to the “referral services” safe harbor under the AKS;
protection for cost-sharing waivers, including certain Medicare Part D cost-sharing waivers by pharmacies, cost-sharing waivers for emergency ambulance services furnished by state-owned or Indian tribe-owned ambulance service providers;
protection for certain remuneration between Medicare Advantage organizations and federally-qualified health centers; and
protection for discounts in the price of an “applicable drug” of a manufacturer that is furnished to “applicable beneficiaries” under the Medicare Coverage Gap Discount Program.

Proposed Revisions to the CMP Regulations

In addition to adding a gainsharing provision to the CMP regulations, the OIG proposes to amend the definition of “remuneration” in the CMP regulations by adding statutory exceptions for:

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 generic drugs.

Conclusion

The proposed rule, if adopted, would have a major impact on the AKS and CMP regulations. The proposed safe harbor protecting free and discounted local transportation may be of particular interest to the AHRA community. Imaging providers and suppliers offering transportation services, or those who are interested in offering transportation services, should stay tuned for the final rule. The public may submit comments on the proposed rule through December 2, 2014.

Adrienne Dresevic, Esq. graduated Magna Cum Laude from Wayne State University Law School. Practicing healthcare law, she concentrates in Stark and fraud/abuse, representing various diagnostic imaging providers, e.g., IDTFs, mobile leasing entities, and radiology and multi-specialty group practices.

Leslie Rojas, Esq. graduated from Wayne State University Law School and is licensed to practice law in Michigan and Illinois. Practicing healthcare law, she concentrates on fraud/abuse issues, compliance with federal and state healthcare regulations, health information privacy and technology issues, and transactional and corporate aspects of healthcare.

The authors are members of The Health Law Partners, P.C. and may be reached at (248) 996-8510 or (212) 734-0128, or at www.thehlp.com.

For more regulatory news, visit www.ahraonline.org/news.