On January 23, the Centers for Medicare & Medicaid Services (CMS) released revisions to its Voluntary Self-Referral Disclosure Protocol (SRDP), an important mechanism through which providers may disclose actual or potential violations of the federal physician self-referral prohibition commonly known as the Stark Law. The updated forms include a new Group Practice Information Form that may streamline the process for disclosures concerning noncompliance with the “group practice” definition, or at least reduce the paperwork. The updated forms also incorporate a few other changes that reduce the burden on providers and may improve the efficiency of the review process. Disclosing parties may use the updated forms effective immediately. They must do so for disclosures submitted on or after March 1, 2023.

Background

The Affordable Care Act required the establishment of a voluntary self-referral disclosure protocol that sets forth a process through which providers may disclose actual or potential violations of the Stark Law. In accordance with this mandate, CMS established the SRDP on September 23, 2010.

Initially, SRDP submissions took the form of letters, often lengthy, that were keyed to an eight-page instruction document from CMS. Beginning June 1, 2017, disclosing parties have been required to make submissions using a series of forms that collect information about the parties, the noncompliance, and the financial analysis. No changes have been made to the forms since that time.

Revised SRDP Forms

The revised SRDP forms include a new Group Practice Information Form. The Group Practice Information Form should be submitted by physician practices only where the practice is reporting noncompliance arising from the failure to qualify as a “group practice” under 42 C.F.R. § 411.352. In such cases, the disclosing party need not complete Physician Information Forms for each involved physician. In all other cases, including disclosures by physician practices that relate to noncompliance with the in-office ancillary services exception, the disclosing party should continue to use the Physician Information Forms.

The Group Practice Information Form requires the disclosing party to identify each element of the “group practice” definition that the practice failed to satisfy. The form includes specific prompts for each of the requirements of 42 C.F.R. § 411.352 that are intended to cause the disclosing party to describe precisely how the practice failed to satisfy the requirements. For example, if the noncompliance relates to the payment of improper productivity bonuses, the disclosing party should not only describe the methodology used to calculate productivity bonuses but also provide other information relevant to CMS’s assessment of the matter, including (1) the number of designated health services CPT/HCPCS codes for which physicians received productivity bonuses that were neither personally performed by physicians nor services “incident to” such personally-performed services, as well as the total number of unique CPT/HCPCS codes billed by the practice; (2) the revenues derived from designated health services; and (3) the number of affected physicians in the practice.

The form also requires the disclosing party to submit a single spreadsheet with information about the physicians who made prohibited referrals to the practice, including a statement of whether each physician is or was an owner, employee, or independent contractor of the practice; a statement of whether the physician received compensation in a manner that was inconsistent with the group practice requirements; and a description of the period noncompliance. In many respects, the Group Practice Information Form collects information that would have been disclosed under the current SRDP forms. But it does so more efficiently and the specific prompts should facilitate the resolution of disclosures by ensuring that the disclosing party includes all information deemed relevant by CMS.

Aside from adding the Group Practice Information Form, the revised instructions permit a disclosing party to submit a single Physician Information Form for all physicians who stand in the shoes of their physician organization. More specifically, if the disclosing party is disclosing multiple compensation arrangements with physicians due solely to the fact the physicians are deemed to stand in the shoes of the physician organization that is party to the noncompliant arrangement, then the disclosing party may submit a single Physician Information Form along with a list of each physician who is deemed to have the same noncompliant compensation arrangement as the physician organization. The list should not only identify the physicians but also describe the period of noncompliance for each physician relative to the noncompliant compensation arrangement.

The revised instructions also do away with the requirement to submit a hard copy of the certification statement. Previously, the SRDP required disclosing parties to send complete copies of disclosures via email but to separately send a hard copy of the signed certification to CMS’s Division of Technical Payment Policy. Now, the entire submission, including the signed certification, may be submitted electronically.

Takeaways

CMS’s changes to the SRDP are limited in scope. They do, however, provide some relief in a couple of frequently occurring scenarios. According to CMS, the majority of self-disclosures that report noncompliance involving multiple physicians in the same physician organization involve either (1) group practice noncompliance or (2) arrangements that are deemed to be between entities and physicians under the stand in the shoes rules.Taken together, the new Group Practice Information Form and the special rule for physicians who stand in the shoes of their physician organization allow parties to report these types of noncompliance in a simpler, less voluminous manner.

With that said, the revisions do not change how parties should disclose what might be characterized as adjacent instances of noncompliance. For example, when a group practice fails to satisfy the requirements of the in-office ancillary services exception, the disclosing party may not use the Group Practice Information Form. Instead, because the facts of each physician’s prohibited referrals will differ, the disclosing party should continue to submit separate Physician Information Forms. Likewise, when a party discloses noncompliance with respect to its compensation arrangements with physicians who are not in the same physician organization, it should submit separate Physician Information Forms even if the factual details of the compensation arrangements are virtually identical.

If you have any questions about the revisions to the SRDP, or about the SRDP process generally, please contact the authors.