ACP Resources Help Physicians Navigate Changes to the Stark Law and Anti-Kickback Statute Regulations

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The new rules aim to provide physicians more flexibility while continuing to maintain safeguards against fraud and abuse

Oct. 15, 2021 (ACP) – The Stark Law and Anti-Kickback Statute (AKS) have both gone through a round of revisions this year, and the American College of Physicians has created new resources that will help members understand how things have changed.

More than a generation ago, a California congressman named Pete Stark passed a bill in Congress that aimed to prevent kickbacks via certain referrals by physicians who are reimbursed by Medicare and Medicaid. This became known as the Stark Law. The AKS prohibits physicians from knowingly offering, paying, soliciting or receiving remuneration to induce or reward the referral of business reimbursable under any federal health care program.

In November 2020, the Centers for Medicare & Medicaid Services announced changes to what the agency referred to as “outdated” federal regulations in the Stark Law and AKS that burdened health care professionals with additional administrative costs and impede the health care system move toward value-based reimbursement. The changes went into effect on Jan. 19, 2021.

“ACP members should understand that these changes focus on building a system that delivers value by way of pioneering new models in Medicare and Medicaid to remove burdens that impede care coordination,” said Brian Outland, ACP director of regulatory affairs. “These revisions are consistent with the 2017 initiative by CMS called Patients over Paperwork, which in terms aligns with ACP's previously established Patients Before Paperwork efforts. It seeks to adjust rules to offer more flexibility in the way physicians can comply with the laws. Before these changes, physicians were growing increasingly concerned that the requirements of the regulations were a burden that took away from the care of patients and impeded practice. The modifications to the Stark Law should help physicians realize the agency's intent, thereby benefiting patient care.”

As Outland explained, the new Stark Law rules “were designed to give physicians more flexibility (while simultaneously maintaining safeguards to protect patients and federal health care programs from fraud and abuse), reduce costly administrative burden and allow for greater participation in value-based payment arrangements.”

Outland added that the most notable new rules may be the exceptions that permit a broad range of value-based activities. “These changes were supported by ACP since these activities could have been deemed problematic under the previous law absent these new protections for value-based arrangements and patient care coordination activities,” he said.

ACP's new resources can be found here. Outland credited Dejaih Johnson, an ACP associate in regulatory affairs, with playing a major role in creating the resources, which cover both Stark Law reforms and changes to the AKS.

“It is important that our members understand that provisions and requirements across the two laws are similar but apply in different contexts and have different implications,” Outland said. “To help illustrate this, ACP created a chart detailing the differences between the Stark Law and the AKS, inclusive of situational applicability, exceptions, requisite intent, penalties, etc.”

ACP also created a Frequently Asked Questions section to provide more insight into the nuances of the laws. “We will keep these updated as regulatory requirements change and we receive additional questions and feedback from our members,” Outland said. “Finally, we will shortly be publishing a series of analyses highlighting key changes and their impact to physicians and different arrangements. These will take the format of PDFs so members can print these and have them on-hand for consultation.”

Moving forward, he said, “it is our hope that these resources serve as a point of consult and ease the nervousness and uncertainty around the recent changes to the Stark Law and AKS, but also the laws and regulations more broadly. We continue to encourage members to submit to ACP any and all questions that they or their colleagues come across so we may include those in our set of FAQs.”

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