1. Signed Writing Requirement
Stark Law requires that agreements that fall into the safe harbor provisions must be in writing and executed by the parties. Prior to the BBA changes, it was argued the writing needed to be a single contractual document that complied with strict Stark Law requirements.
Several Qui Tam cases were brought against health care providers, arguing the failure of the writing requirement was not insubstantial and, therefore, the absence of the signed writing could give rise to a successful false claims suit. The courts struggled with the rule and often the health care provider was left to pay the price
The BBA did not change the need for an executed writing, but it did make it clear that the writing requirement could be satisfied with a series of documents that show the existence of a signed agreement that complies with Stark Law regulations.
The BBA modification states, “… by a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties involved.”
The Stark Law writing requirement is not in line with contract law and the basic steps necessary to prove the existence of a contract.
2. Signature requirement
Prior to the BBA clarification, the signature requirement was often confusing, using language related to noncompliance, inadvertent noncompliance, and not-inadvertent noncompliance.
The new rule allows claims submission when the signature requirement is missing provided, “… not later than 90 consecutive calendar days immediately after the date on which the compensation arrangement became noncompliant (without regard to whether any referrals occur or compensation is paid during such 90-day period) and the compensation arrangement otherwise complies with all criteria of the applicable exception.” 42 CFR 411.357(g)
3. Holdover lease and personal service arrangement (“PSA”)
The BBA modified Stark to allow holdover and expired PSA agreements to indefinitely meet the requirements of Stark exception to office space, rental agreements, and PSAs. The agreement must have been for at least one year, and all other terms of the agreement must meet the Stark exception criteria.