The U.S. Department of Health & Human Services Office of Inspector General (“OIG”) issued a proposed rule Oct. 2 that would add new safe harbors to the Anti-Kickback Statute (“AKS”) regulations and interpret existing, statutory safe harbors. The rule would also amend the Civil Monetary Penalties (“CMP”) regulations by adding statutory exceptions to the regulatory definition of “remuneration” and codifying the so-called “gainsharing CMP” found in the Social Security Act.

The full text of the proposed rule may be found here. Some highlights include:

  • A proposed anti-kickback safe harbor that would protect emergency ambulance service providers that offer uniform reductions or waivers of cost-sharing amounts, so long as the ambulance provider or supplier: (i) is owned and operated by a state, state subdivision, or federally recognized Indian tribe; and (ii) is the Medicare Part B provider or supplier of the ambulance services. Note the safe harbor would not apply to contracts with outside ambulance providers or suppliers, and a governmental unit cannot require its contracted ambulance provider or supplier to waive or reduce beneficiaries’ cost-sharing amounts unless the governmental unit pays or makes arrangements to pay those amounts.
  • A proposed anti-kickback safe harbor that would protect “eligible entities” who provide to “established patients” free or discounted local transportation within the healthcare provider’s local area for purposes of obtaining medically necessary items or services, so long as certain conditions are met. Some conditions include: (i) not marketing or advertising the services; (ii) not determining the availability of transportation services in a manner related to the past or anticipated volume or value of federal health care program business; and (iii) not paying drivers or those who arrange for transportation on a per-beneficiary basis. The OIG also noted numerous considerations related to the final content of the safe harbor and is soliciting comments on each. Some considerations include:  (i) whether a secondary form of transportation, such as a shuttle, should be covered; (ii) whether the safe harbor should be limited to the provision of transportation for medical purposes, or if entities may also provide transportation for other purposes related to the recipient’s overall health (e.g. trips to food banks/grocery stores, trips to obtain counseling and social services, etc.); and (iii) whether the allowable scope of transportation should be measured by distance or travel time.
  • A proposed exception to the definition of “remuneration” for “any other remuneration which promotes access to care and poses a low risk of harm to patients and Federal health care programs.” Under OIG’s proposal, “promotes access to care” will mean the remuneration provided improves the beneficiary’s ability to obtain medically necessary health care items and services, and  “low risk of harm” will mean the remuneration is unlikely to skew clinical decision-making, unlikely to increase costs to a program through overutilization or inappropriate utilization, and does not raise patient safety or quality-of-care concerns. OIG is seeking specific comments on how to safeguard against inappropriate forms of remuneration or incentives. (For example, when is it beneficial and low-risk to reward patients with an incentive for achieving treatment milestones?) Further, OIG is also broadly requesting comments on “other types of remuneration to beneficiaries not mentioned [here] that both promote access to care and pose a low risk of harm to Medicaid and Medicaid beneficiaries.”

Overall, the proposal appears to signify OIG’s recognition that the healthcare landscape has shifted, and new healthcare delivery models that center on shared risk and coordinated care require a degree of flexibility in the current regulations and an acknowledgment that some activities’ benefits to both patients and providers outweigh potential fraud and abuse concerns.

By issuing this proposed rule and soliciting for very broad comments, OIG has taken an important step to engage stakeholders to help develop a regulatory framework that strikes a balance between deterring arrangements harmful to federal health programs and their beneficiaries and encouraging provider-patient collaboration to improve care and reduce costs.