The procedure for voluntary self-disclosure of actual or potential Stark Law (federal physician self-referral law) violations has changed. As of June 1st, 2017, those providers wishing to make a Stark Law self-referral disclosure must submit all relevant information via Form CMS-10328 which includes four parts.
The Centers for Medicare and Medicaid Services (CMS) now require the following elements for voluntary self-disclosure:
- The SDRP Disclosure Form, which contains information about the disclosing party, the occurrence(s) that took place, and what measures are being taken to ensure non-compliance does not continue in the future.
- The Physician Information Form, which is required for each physician involved in the noncompliance and includes details relating to the financial relationship(s) between them and the disclosing party,
- A Financial Analysis Worksheet detailing the amount of overpayment as it relates to each physician’s referral(s), and
- Certification that the aforementioned information is accurate.
How Have the Disclosure Elements Changed?
While much of the required documentation is very similar to those required by the SRDP prior to June 1st, 2017, there are several differing elements:
- If the disclosing party files for bankruptcy, or has a change in ownership or a designated representative, it MUST inform CMS of that information by e-mail.
- Some information is no longer required, such as the disclosing party’s evaluation and description of its pre-existing compliance program.
- No longer does a disclosing entity have to submit information as it relates to the financial benefits of a noncompliant relationship.
- The SDRP Disclosure Form requires disclosure of the pervasiveness of the noncompliance as a means of comparing it with similar financial relationships.
- As it relates to pervasiveness, the revised SDRP provides guidance in the form of detailed examples as they relate to the “stand in the shoes” provisions of the Stark Law.
- While each physician must complete the Physician Information Form, the disclosing entity might be required to submit multiple forms if the practice doesn’t meet the Stark Law definition of a group practice.
- The Physician Information Form now includes checkboxes that “allow parties to quickly identify those elements of an applicable exception that a financial relationship satisfied and those elements that the relationship failed to satisfy.”
- Regarding the Physician Information Form, the disclosing entity must either certify that the financial relationship was noncompliant, or, if they can’t confirm its compliance, they must certify it as noncompliant.
How to Know If You Are Compliant
If you have any concerns about Stark Law compliance, including completion of any or all of the aforementioned forms, it is best to seek the counsel of an experienced healthcare attorney.