The Department of Health and Human Services Office of Inspector General (OIG) Dec. 6 issued a final rule that amends safe harbors to the Antikickback statute (AKS) and changes the civil monetary penalty rules to allow certain renumeration to patients who pose a low risk of harm. The AKS prohibits the exchange of anything of value in an attempt to induce a referral for federal health care program business. However, there are “safe harbors” that protect beneficial arrangements that enhance the efficient and effective delivery of health care and promote the best interests of patients.
A noteworthy expansion in the final rule is a new safe harbor that permits “eligible entities” to provide free or discounted local transportation to “established” patients to access medically necessary services. For example, a hospital could establish a complementary transportation arrangement to transport patients to the hospital’s campus if properly structured. The rule outlines certain criteria that must be met to meet the safe harbor, which includes a limitation of distance of 25 miles and excludes air, luxury, or ambulance-level transportation.
The rule also amends the definition of “renumeration” in the civil monetary penalty (CMP) regulations by interpreting and incorporating certain 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. Examples could include computers and smartphone applications, home monitoring services, telemedicine capability, and others;
- Coupons, rebates, or other retailer reward programs that meet specific requirements;
- Certain remuneration to financially needy individuals; and
- Copayment waivers for the first fill of generic drugs.