Legally speaking By Diane Millman
Legal considerations for patient- centered care
A look at the laws related to beneficiary inducement
In light of the rise of patient-centered care as the new mantra for health care regulators, physicians and other providers might be tempted to believe that providing Medicare and Medicaid patients free preventive screenings, help with health care–related transportation, lodging and similar expenses, reductions in co-pays, and financial assistance in obtaining other supportive items and services that are needed to improve health outcomes would be universally viewed positively by regulators.
Unfortunately, it isn’t necessarily so: While some of the rules related to “beneficiary inducements” appear to be relaxing as the result of new exceptions created by the Affordable Care Act (ACA), care is still needed to avoid legal pitfalls.
Legal risks The legal risks that arise in this area stem from two statutory provisions. The first is the antikickback provision, which, among other things, precludes the payment of any remuneration to a patient covered by Medicare, Medicaid or certain other governmental health programs to obtain covered services.
The second is the beneficiary inducement prohibition of the Civil Monetary Penalties (CMP) law, which provides that a person who offers or provides any remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier may be liable for civil money penalties, subject to a limited number of exceptions.
Because these two provisions are separate and distinct, a financial benefit to a beneficiary that is eligible for an exception under one of them could still violate the other (at least theoretically). For example, one or both of these prohibitions may be triggered by wellness programs/health fairs/health promotion; patient assistance
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programs; transportation/lodging assistance; and incentives that promote adherence to treatment regimens.
“Safe harbor” regulations There are specific safe harbors regulations for certain free or discounted benefits provided to beneficiaries, such as co-insurance waivers. There is also a new safe harbor for free or discounted transportation that meets certain requirements. Remuneration that meets the requirements in these regulations are not subject to potential liability under the antikickback prohibition. But there are no safe harbors for patient benefits such as free screening, participation in health fairs, or health promotion.
Patient assistance programs that, for example, shield Medicare beneficiaries from reductions or waiver of co-insurance need to be carefully circumscribed to avoid scrutiny under the antikickback laws. (Just ask Pfizer, which recently paid $24 million to settle a case involving a co-pay assistance program for an atrial fibrillation drug).
The safe harbors leave in limbo many types of free and discounted services that have the potential to improve the quality or reduce the cost of health care. That is, arrangements that do not meet safe harbor requirements are not necessarily illegal under the antikickback law but rather fall into a grey area where legality is based on the individual facts and circumstances involved.
Exceptions The beneficiary inducement provisions of the CMP law exclude from the definition of prohibited beneficiary remuneration a number of beneficiary benefits that may be of interest to IRs and other physicians. For example, the beneficiary inducement statute and regulations allow the provision of incentives to promote the delivery of those preventive care services that are covered by Medicare or Medicaid, so long as the payment is not cash and is not disproportionate to the
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