In the ever-changing landscape of anti-kickback regulations, a new rule is in the mix that imaging providers should understand. While there is no such thing as a free lunch, a free ride is legitimate when it comes to transporting patients and even a helper to imaging exams. This action is key to opening up access to more patients, as long as providers follow the regulations closely.
On Dec. 7, 2016, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued a final rule expanding the safe harbor provisions of the anti-kickback statute (AKS) and amending the civil monetary penalty (CMP) rule’s definition of “remuneration.” The final rule has a major impact on the AKS and CMP regulations, and is an invaluable resource for imaging providers and suppliers. 1
In particular, the rule has provisions protecting free/subsidized local transportation under both the AKS and the CMP. Imaging providers and suppliers should know of these changes—many in the imaging world will and should seek to utilize the free and subsidized local transportation rules.
The rule adopts positions outlined in the OIG’s proposed rule from Oct. 3, 2014.2 The OIG noted in that proposed rule that any safe harbor offering protection under the AKS would exempt the same practice from the definition of “remuneration” under the CMP law.
The Final Rule on Transportation, Explained
The final rule protects transportation services provided to the patient (and, if necessary, someone to assist the patient) only to obtain medically necessary items or services within the local area (25 miles) of the healthcare provider or supplier (50 miles for rural areas). Safe harbor protection is available for the transportation of “established patients” only. 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 protected if the transportation is limited to patients referred by a particular referral source or the transportation is contingent on a patient seeing a particular provider or supplier who may be a referral source. A provider or supplier also can restrict the offer of free or discounted transportation to patients whose conditions require frequent or critical appointments. However, the provider or supplier can’t restrict the offer to patients receiving expensive treatments that are lucrative for the provider or supplier offering the transportation.
Other scenarios that OIG says are not protected under the safe harbor include:
- Transportation by air, luxury transportation (e.g., limousine), or ambulance-level transportation;
- Transportation involving payment to the transporter on a per-beneficiary basis (as opposed to an hourly or mileage basis);
- Transportation services publicly advertised to patients or potential referral sources; and
- Transportation that includes marketing healthcare items and services during the transportation (not including signage on the vehicle designating the source of the transportation).
These exclusions follow the OIG’s longstanding guidance on these issues. The final rule further requires that the free and subsidized transportation policy be included in a written and adhered to policy that is applied uniformly and consistently. It cannot be determined in a manner related to the past or anticipated volume or value of federal health care program business.
The rule also prohibits the eligible entity from publicly marketing or advertising the free and subsidized transportation. The financial burden of the transportation costs can’t be shifted onto any federal health care program, other payers or other individuals.
7 Things to Know
It is important to dig into both the final rule’s requirements and the regulatory thinking in commentary to both the proposed and final rules. They are key to structuring a transportation program.
- General Comments: In response to several general commenters, the OIG agreed that the safe harbor does not need to require that transportation be planned in advance. It protects transportation both to a provider or supplier and back to a patient’s home, and a transportation program can use vouchers rather than having the transportation provided directly by the eligible entity.
- Eligible Entity: The final rule excludes entities that primarily supply healthcare items (including, but not limited to, durable medical equipment suppliers or pharmaceutical companies) from the definition of eligible entities because these types of entities might be more likely to offer transportation to their patients in exchange for referrals. The OIG notes that entities that primarily provide services, but also provide items, such as a hospital with a laboratory or pharmacy, can offer transportation to established patients to its own location for items or services provided by the entity.
- Established Patients: A patient can be “established” after he or she selects and initiates contact with a provider or supplier to schedule an appointment. The rule does not require that he or she has attended the appointment.
- Purpose of Transportation: The OIG proposed and solicited comments on conditions related to the purpose of the transportation and the location which a patient could be transported. In the final rule, the OIG does not protect transportation for purposes other than to obtain medically necessary items or services. They deem the risk too high when transportation is offered for an individual, as opposed to a shuttle service, for non-health-related purposes (transportation to and from appointments is OK).
In response to one commenter, the OIG opines that a transportation program limited to Medicare beneficiaries is unlikely to meet the safe harbor requirement that the transportation offered cannot be determined in a manner related to the past or anticipated volume or value of federal healthcare program business. However, an eligible entity could consider an individual patient’s need for transportation which could cause a disproportionate transportation to elderly or low-income patients. The OIG warns that the determination must be made individually, and not based on insurance type. Transportation to referral sources is not specifically excluded. However, it cannot be contingent on the patient choosing the referral source.
- Need for Transportation: The OIG sought comments on whether eligible entities should have to maintain documented beneficiary eligibility criteria to take advantage of the safe harbor, and after further consideration, finalized a requirement that eligible entities need to have a set policy regarding the availability of transportation assistance. The policy must be applied uniformly and consistently. Interestingly, although the OIG states it is not requiring entities to document transportation assistance provided, if it follows the entity’s policy, it is suggested that it might be best practice to do so.
- Marketing: While transportation within the guidelines is allowed, marketing their availability is not. The transportation can’t be publicly advertised or marketed to patients or other potential referral sources and no marketing of healthcare items or services can take place during the transport. Also, drivers or others involved in arranging the transportation can’t be paid on a per-beneficiary-transported basis. In the final rule, it is made clear that advertising the availability of free or discounted transportation extends to online and printed materials available to the public.
- “Local” Transportation: As the name implies, the Local Transportation Safe Harbor protects “local” transportation which is 25 miles for patients in urban areas and 50 miles in rural locales. Mileage can be measured directly (i.e., as the crow flies), which would include any route within that radius (even if the route is over 25 or 50 miles when driven). So imaging providers must make the free or discounted transportation available only “within 25 miles of the healthcare provider or supplier to or from which the patient would be transported, or within 50 miles if the patient resides in a rural area.”
The OIG’s Local Transportation safe harbor is an important step towards loosening existing fraud and abuse rules to promote access to care. Properly structured, imaging entities have new avenues to use free and subsidized transportation for their patients without risk of violating the AKS or the CMP.
Adrienne Dresevic, Esq., and Clinton Mikel, Esq., focus their practices on healthcare law with The Health Law Partners, P.C., in Southfield, Mich.
- Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements; 2016.
- Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing; 2014.