The Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) are trying to reduce regulatory burdens on healthcare organizations with rule changes that would protect some activities from anti-kickback allegations. The changes are intended to promote value-based care.

  • The rule changes could give physicians more flexibility in treatment options.
  • HHS and CMS are proposing new exceptions to the Stark law and other anti-kickback laws.
  • Many healthcare organizations support the proposed changes.

The Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) are continuing their plan to ease burdens on healthcare providers by amending the Stark law, the Anti-Kickback Statute (AKS), and the Civil Monetary Penalties Law.

The HHS Office of Inspector General has proposed revisions to ease requirements under existing AKS safe harbors. The proposed changes involve electronic health records (EHRs), warranties, local transportation, and personal services and management contracts.

This effort to reduce regulatory burdens is part of the HHS Regulatory Sprint to Coordinated Care, says Jayme R. Matchinski, JD, an officer with Greensfelder in Chicago. That program aims to encourage value-based arrangements and patient care coordination, allowing some activities that otherwise might be considered forbidden by current law.

“This is good news for healthcare organizations,” she says. “This is an opportunity to pursue quality healthcare without having to face obstacles that were meant to deter fraud but that, in practice, often got in the way of doing the right thing for the patient.”

The proposed changes would add new value-based exceptions to Stark, provide new safe harbors under the AKS, and revise some AKS safe harbors.

Healthcare Is Different Now

The proposed changes should reduce burdens for healthcare providers and allow greater flexibility while still discouraging fraud and abuse, Matchinski says.

A statement from HHS explained that “The Stark law’s new value-based exceptions, under the proposed rule issued by the Centers for Medicare & Medicaid Services, acknowledge that incentives are different in a healthcare system that pays for value, rather than the volume, of services provided. They include proper safeguards that ensure the Stark law will continue to provide meaningful protection against overutilization and other harms, while giving physicians and other healthcare providers added flexibility to improve the quality of care for their patients.”

The proposed changes would address “the longstanding concern these laws unnecessarily limit the ways in which healthcare providers can coordinate care for patients,” HHS said. “The changes would offer flexibility for beneficial innovation and improved coordinated care through, for example, outcome-based payment arrangements that reward improvements in patient health. The changes also would make it easier for physicians and other healthcare providers to ensure they are complying with the law by offering specific safe harbors for these arrangements.” (The statement can be found at: https://www.hhs.gov/about/news/2019/10/09/hhs-proposes-stark-law-anti-kickback-statute-reforms.html.)

Healthcare organizations have responded positively to the proposed changes. Janis Orlowski, MD, chief health officer of the Association of American Medical Colleges, issued a statement saying the group commends the “comprehensive efforts in this proposed rulemaking to increase opportunities for hospitals and physicians to engage in innovative arrangements to enhance care coordination, improve quality, and reduce costs. In this rulemaking, CMS takes a major step forward by addressing many of the real-world challenges that hospitals and physicians encounter when trying to structure arrangements that comply with the Stark regulations.” (The statement can be read at: https://www.aamc.org/system/files/2019-12/ocomm-ogr-AAMC%20Comment%20Letter%20CMS%20Stark%20Proposed%20Rule%2012.30.2019.pdf.)

The American Medical Group Association echoed those sentiments with a statement saying the group is “supportive of these exceptions, which would allow providers to take more innovative approaches in their financial arrangement while encouraging and removing barriers to value-based care.” (The comments are available at: https://www.amga.org/AMGA/media/PDFs/Advocacy/Correspondence/CMS%20Correspondence/Physician%20Self-Referral/Cmts-on-Physician-Self-Referral-Proposed-Rule.pdf.)

Home Dialysis Could Benefit

One proposed improvement cited by HHS and CMS involves in-home dialysis treatment. HHS says that health outcomes could be improved for patients with end-stage kidney disease by allowing a nephrologist, dialysis facility, or other provider to use telehealth to monitor and communicate with the patient.

Matchinski says this would be a huge step forward for these patients, and it is a good example of how the proposed changes could improve care by eliminating unnecessary roadblocks.

“Since the Affordable Care Act, HHS has strengthened its healthcare fraud and abuse oversight, so this is interesting that they are trying to move away a little bit from that,” she says. “The Affordable Care Act gave the federal government a stronger tool belt to go after fraud and abuse, but now HHS is putting in this value-based exception to the Stark law, adding these proposed additional safe harbors. They’re looking at how these value-based arrangements can improve care and easing some of the restrictions to provide a little more flexibility.”

There still will be penalties for persons or entities offering remuneration that violates Stark or other laws, but the proposed rules alter the definition of remuneration and specifically allow some activities like telehealth for in-home dialysis, Matchinski explains.

“This new safe harbor would support that arrangement for end-stage renal disease and in-home dialysis, which would allow healthcare organizations to provide this service in the way that is best for these patients. They currently can’t do that without fear of violating Stark or other anti-kickback statutes,” she says. “They would have an exception so that it would not be considered remuneration under the Anti-Kickback Statute.”

With the proposed changes, an end-stage renal disease patient would not have to make a trip to the hospital or clinic for a face-to-face evaluation by a physician to receive dialysis, Matchinski explains.

“It can be a telehealth visit as long as there is documentation that the intention is not to steer the provider to a particular provider or supplier. My clients have been looking at this and making sure they have the right forms showing the client understands how the patient care is going to be delivered,” she says. “Telehealth technologies cannot be an advertisement or a solicitation. Telehealth has to be about providing services for those end-stage renal disease patients, and the providers have to be aware of the change in technology. The provider has to document that this telehealth technology significantly adds to the provision of the patient’s care.”

Value, Freedom of Choice Required

In addition, the telehealth service cannot be of “excessive value.” Matchinski says this is the area that HHS and CMS will police closely.

“You can’t provide a $600 smartphone when a $300 smartphone would be adequate for the technology,” Matchinski says. “You have to use efficient telehealth technology, not necessarily the most expensive. You also can’t use duplicative technology, providing the patient a smartphone if they already have one that will work with the technology.”

The healthcare organization providing the telehealth technology also must document that the patient has been informed of his or her right to obtain healthcare services from any provider, that the provision of technology does not bind the patient to that healthcare provider.

“This changes the game for a lot of end-stage renal disease patients and eases the enforcement obligation for HHS,” Matchinski says. “Make sure you have good documentation for medical necessity, that the telehealth technology meets the requirements for multimedia communications, and the freedom of choice form must be reviewed and signed to show that the patient understands care can be obtained elsewhere.”