Legal and Regulatory Compliance

Although relaxed regulations under Stark Law and anti-kickback statutes encourage better care coordination for patients, there’s also higher risks of noncompliance

January 22, 2021 12:48 am

Venson Wallin, FHFMA, CHFP, CPA, managing director, BDO Consulting

Proposed changes to Stark Law and anti-kickback statutes are encouraging more provider organizations to participate in value-based care models, according to Venson Wallin, FHFMA,  CHFP, CPA.

The opportunities and challenges associated with those changes were explained by Wallin, a managing director with BDO Consulting, during a presentation Wednesday as part of HFMA’s Digital Annual Conference.

The proposed changes were released in October 2019 and were originally to be finalized by spring 2020, but the coronavirus pandemic slowed down the process, Wallin said.

“The government’s had their hands pretty full … so finalizing these rules has not been the top priority,” he said.

In general, the changes are intended to make the rules more lenient and encourage participation in value-based care models, Wallin said. In the past, providers were reluctant to enter such arrangements because the rules were so strict that it was difficult to avoid breaking them.

 “The current Stark and anti-kickback statutes somewhat inhibit innovation, and they really discouraged outcomes-based arrangements,” he said. The proposed rules will encourage hospitals, physicians and vendors to work together and remove barriers to value-based care arrangements.

However, with those relaxed rules come new compliance risks, Wallin cautioned. In the past many arrangements have been somewhat standard, which has prevented some organizations from having to do a comprehensive legal review. However, that is no longer the case.

 “It’s no longer a standard template that can be used to enter arrangements,” he said. “There are going to be so many different types of potential arrangements that having a more intense legal review is going to be necessary to address any possible risks.”

Three opportunities of relaxed rules

The new rules provide opportunities in three key areas, according to Wallin.

1. Hospitals and physicians are encouraged to become more engaged with patients to better  address patients’ ongoing care and reduce any chronic illness, which will lower overall costs,

2. More opportunities to use technology to coordinate care. For example, providers can employ wearable devices that patients can use to monitor blood pressure, glucose levels, heart rate, oxygen, etc.

3. Increased communication among providers to ensure patient care is coordinated to provide better care at a lower cost.

“With leniency comes responsibility”

CMS and OIG will be watching closely to ensure provider organizations are following the rules, Wallin said.

“With the leniency and ability and encouragement of entering into the arrangements, sharing of data, sharing of technology, working together … there will be some more opportunities for people to take advantage of the system … in a bad way.”

With increased leniency, it will be easier for providers to move into gray areas that aren’t in the spirit of the new revisions, Wallin said.

 “If it doesn’t feel right, it’s probably not right,” he said. “Always make sure that you’re having someone, from a legal perspective, review the arrangements to ensure that they are appropriate and keeping with the proposed rule.”

How to address the challenges

CMS will be keeping a closer eye on value-based care arrangements, and provider organizations should be prepared, Wallin said. He suggested three key areas of focus.

1. The provider organization’s governmental affairs office or department should be fully prepared to keep up to date on the new and ever-changing rules. Governmental affairs review should be enhanced to monitor revisions and ensure all stakeholders understand them. It’s also important to note that the rules are not yet final, he said. There could be key changes between the proposed rules and the final ones. Even once the rules are finalized, OIG and CMS will probably continue to look at results and tweak the rules to tighten any potential opportunities for fraud and abuse, he said.

2. Data analytics should be monitored, Wallin said. Provider organizations should be sure that what’s being reported is appropriate and accurate. Educate all stakeholders on what’s being measured, what data elements go into those measures make sure they’re being pulled correctly. Cybersecurity also is an issue, so software should be updated, and all vendors thoroughly vetted.

3. Healthcare organizations should regularly review their compliance program to ensure it addresses arrangements as they relate to new regulations, Wallin said. The compliance department is going to be integral to staying current with compliance to this and other new regulations.


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