Hospitals to OIG: Please give us anti-kickback safe harbors for value-based care 

Patient and nurse in hospital
Hospital groups are weighing in on how the OIG can reform the anti-kickback laws to make it friendlier to value-based care. (Getty/monkeybusinessimages)

Anti-kickback statutes stand in the way of growing participation in value-based models, hospitals warn. 

Major hospital groups were among the slew of industry stakeholders who weighed in on the Department of Health and Human Service Office of Inspector General’s request for information on ways to reform the Stark and anti-kickback laws

In its letter (PDF) to OIG, the Federation of American Hospitals said value-based payments are “hindered by the existing fraud and abuse regime.” To address this, OIG should build an overarching waiver to anti-kickback laws for advanced payment models run by the Centers for Medicare & Medicaid Services. 


2019 Drug Pricing and Reimbursement Stakeholder Summit

Given federal and state pricing requirements arising, press releases from industry leading pharma companies, and the new Drug Transparency Act, it is important to stay ahead of news headlines and anticipated requirements in order to hit company profit targets, maintain value to patients and promote strong, multi-beneficial relationships with manufacturers, providers, payers, and all other stakeholders within the pricing landscape. This conference will provide a platform to encourage a dialogue among such stakeholders in the pricing and reimbursement space so that they can receive a current state of the union regarding regulatory changes while providing actionable insights in anticipation of the future.

Provider groups, including the American Hospital Association, have long argued that the Stark and anti-kickback laws pose a major barrier to care coordination, a crucial piece of these new payment arrangements. 

RELATED: CMS seeks ‘bold ideas’ as it makes reducing regulatory burden of the Stark law a top priority  

The Medicare Access and CHIP Reauthorization Act signaled how much the federal government values these new models, FAH said, but hospitals need the flexibility to align participants and offer incentives. A broad waiver to address this problem would reverse OIG’s current approach, which is to review waivers for alternative payment models on a case-by-case basis.  

The changes would offer a sense of consistency across APMs and “will provide to hospitals and physicians the confidence necessary to move forward with meaningful alignment strategies that further quality, reduce waste, and improve patient outcomes,” FAH said. 

For advanced payment models operating outside of CMS’ purview, OIG should offer providers anti-kickback safe harbors in these arrangements, FAH said. 

“Provided that the compensation to be received is fair market value, does not take into account the volume or value of referrals and is commercially reasonable, the arrangement should be deserving of safe harbor protection,” the group said. 

RELATED: Athenahealth floats kickback carve-out that would allow physicians to pay for clinical data exchange 

FAH’s suggestions were echoed in letters from other hospital groups. America’s Essential Hospitals also pushed (PDF) for broader waivers for APMs and suggested that the OIG consider narrowing its use of anti-kickback and civil monetary penalty statutes. 

Anti-kickback provisions, AEH said, are overly broad and could apply to any payment that has an impact on referrals, even if ultimately it leads to better care or otherwise benefits patients. At the same time, existing anti-kickback safe harbors are very narrow, the group said. 

Narrowing the use of these statutes would offer providers greater certainty in the work they’re doing and would allow for clarification of regulatory requirements, AEH said. 

“Regulatory uncertainty has put essential hospitals in an untenable position,” AEH said. “The very activities our members undertake to support new delivery system and payment models—actives the Centers for Medicare & Medicaid Services and Congress have encouraged—increase their exposure under the AKS and CMP law.” 

RELATED: OIG’s anti-kickback request for information offers providers an opportunity for ‘legal clarity’ 

The Association of American Medical Colleges, which represents academic medical centers, noted (PDF) that the Stark and anti-kickback laws are relics of a healthcare system that hadn’t yet conceived of value-based models. 

Because alternative payment models are tightly regulated, it’s unlikely that patients would receive poor care, AAMC said. So CMS and OIG need to continue to evolve the policies governing these models to draw in more participants. 

“It is critical that CMS, the OIG, and other associated agencies coordinate their efforts to allow waivers of the physician self-referral law, the civil monetary penalties and anti-kickback laws, as appropriate to support the clinical and financial integration needed for the success of these new delivery and payment models,” AAMC said. 

Suggested Articles

Researchers at two universities plan to develop an autonomous trauma care system that uses robotics and artificial intelligence to treat soldiers.

A change to the government’s voluntary bundled payment model for oncology is going to be bad news for many participants.

CMS Administrator Seema Verma said it will be crucial to have more conversations on how to address emerging—and expensive—therapies.