With Stark Changes in Effect, Compliance, Self-Disclosure Are Whole New Ballgame

CMS officials say they massaged the Stark regulations to reduce the burden on providers, improve their compliance, reduce submissions to the self-referral disclosure protocol for technical violations of the Stark law and promote reform of health care payment and delivery systems. For starters, CMS recast agreements under the compensation exception to the Stark law, including employment agreements, leases of office space and equipment, personal services agreements, fair-market-value compensation and isolated transactions. The regulations previously used the terms “agreement” and “arrangement” interchangeably when it came to the writing requirement of the compensation exception. The terminology implied different requirements, and the use of the word ‘agreement’ led people to conclude that to satisfy the writing requirement, a formal agreement had to be signed by both parties, “so the final rule removed the term ‘agreement.’” The change in terminology represents something deeper than semantics. Apparently CMS wants entities that provide designated health services (DHS) to have more flexibility in the way they establish and document deals with their referring physicians, and vice versa, without losing the spirit of the Stark self-referral law. “Shift from thinking about agreements to thinking about arrangements,” said Matthew Edgar, a health insurance specialist in the CMS Division of Technical Payment Policy. The Stark law prohibits Medicare payments to entities for DHS (e.g., hospital inpatient and outpatient services) if they were ordered by physicians who have a financial relationship with the entities, unless an exception applies. Many exceptions require the agreements between DHS entities and physicians to be in writing. “You don’t need a single formal contract to satisfy the writing requirement for the compensation exception,” Edgar said. While having a formal contract is a best practice, “it’s not strictly necessary,” he noted. “You can rely on a collection of documents, such as contemporaneous documents that evidence a course of conduct between the parties.” The idea is for the documents to allow a “reasonable person to verify compliance” with the Stark exception at the time the referral is made.

Source: https://aishealth.com