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Stark Law Reform Push Sees Movement on Multiple Fronts

Analysis  |  By Steven Porter  
   August 27, 2018

Regulatory tweaks? Legislative changes? Trump administration officials seem to be considering it all when it comes to potential reforms to the Stark Law, Anti-Kickback Statute.

The window closed Friday night for public comments on a Centers for Medicare & Medicaid Services request for information regarding possible changes to Stark Law and anti-kickback regulations on the healthcare industry.

When the agency announced the RFI earlier this summer, CMS Administrator Seema Verma signaled that both the laws and the regulations stemming from them could be impeding value-based care. Many commenters agreed, arguing that the decades-old restrictions should be scaled back to make room for the industry to generate and implement new ideas.

"New innovative models of care present a challenge for regulators who want to improve care coordination and outcomes via incentivized value-based arrangements without creating legal uncertainty in advancing these goals," AMGA President and CEO Jerry Penso, MD, MBA, said in a statement Friday. The organization submitted a comment on the RFI last week.

Related: AHA Pushes Stark Law Reform: 4 Recommendations

"CMS is in a difficult position, but there are regulatory improvements, however incremental, that can be made to Stark," Penso said.

Beyond the prospect of incremental regulatory tweaks, the information CMS collected could also be used to push for more-permanent legislative changes, says Tobin Lassen, MBA, MPH, chief knowledge officer and co-founder of Global Healthcare Alliance.

"My preference really would be to influence legislation," Lassen tells HealthLeaders. "For the long run, I think that would be the better thing, but you've got to get everybody to agree on that."

We're seeing movement on Stark Law reform on multiple fronts because healthcare leaders are speaking up about what they see as a high priority, Lassen says.

"It is the squeaky wheel, so to speak, that needs the oil right now, so [officials are] paying attention to that because of so many comments," he adds.

Conversations about legislative fixes are already happening on Capitol Hill. Members of the U.S. House heard from Health and Human Services Deputy Secretary Eric Hargan in July that the physician self-referral law needs to be updated. Hargan has been leading what the Trump administration is calling a "regulatory sprint to coordinated care," identifying barriers to care coordination and assessing whether those regulatory hurdles are needed.

To that end, the HHS Office of Inspector General published an RFI of its own on Monday, asking for input on how it might add or alter safe harbors to the anti-kickback statute.

"Through internal discussion and with the benefit of facts and information received from external stakeholders, OIG has identified the broad reach of the anti-kickback statute and beneficiary inducements [civil monetary penalty (CMP)] as a potential impediment to beneficial arrangements that would advance coordinated care," the HHS OIG wrote.

Among questions about potential arrangements that interest the industry and how the government might be able to support those without going easy on fraud and abuse, the HHS OIG request sought assistance in defining a list of sometimes-nebulous terms, such as "gainsharing," "incentive payments" and "value-based care."

Related: Michigan Hospital to Pay $84.5M to Settle Stark Law, Kickback Claims

Comments submitted in response to the closed CMS RFI are available on, and details on the HHS OIG RFI are available in the Federal Register.

One important thing to keep in mind is that the Stark and anti-kickback laws should not simply be repealed, Lassen says.

"We have to protect Medicare beneficiaries. But I think there are probably ways to make these laws a lot more simple to follow, rather than continue to create waivers around the mechanical rules, each waiver being a little bit different from the other depending on the program," he says. "That can get complicated."

Editor's note: A previous version of this story included a link to the wrong AMGA letter. It has been corrected.

Steven Porter is an associate content manager and Strategy editor for HealthLeaders, a Simplify Compliance brand.


One request for information by the HHS OIG opened the day another by CMS closed.

Officials have telegraphed that they view current regulations as possible impediments to value-based care.

In addition to possible agency action, there has been talk of potential legislative action in Congress as well.

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