Streamlined Process or Added Burden: CMS Seeking Comment to Proposed Self-Referral Disclosure Protocol Form

On May 6, 2016, the Centers for Medicare and Medicaid Services (CMS) released proposed revisions to its self-referral disclosure protocol (SRDP), with public comments due no later than July 5, 2016.¹ CMS’ stated goal of the proposed changes is to “streamline and simplify the SRDP” by issuing a required, standardized SRDP submission form that should reduce the burden on disclosing parties. Realistically, however, the revisions likely will not reduce the burden for disclosing providers. The revised SRDP expands the information required for submission and adds specific data requests that will likely take providers considerable time and resources to compile.

The SRDP enables providers of services and suppliers to self-disclose actual or potential violations of the physician self-referral statute, otherwise known as the Stark Law.² After CMS established the SRDP on September 23, 2010, it was quickly overwhelmed by the large number of SRDP submissions hindering its ability to timely settle with providers. To date, 69 submissions have been settled. No settlements have been announced since December 2014.³

Under the proposed SRDP process, providers must provide a financial analysis of overpayments arising from actual or potential Stark Law violations based on a 6-year, rather than a 4-year, lookback period. While the previous 4-year lookback period was based on the reopening rules, the longer 6-year lookback period brings the SRDP in line with the timeframe established by CMS’ final rule published on February 12, 2016, on reporting and repaying overpayments.⁴

The proposed revisions envision a process by which providers will submit an optional cover letter and four forms: (1) the SRDP Disclosure Form, (2) the Physician Information Form(s), (3) the Financial Analysis Worksheet and (4) the Certification.⁵ While the Certification is substantially the same as the current SRDP format, the remaining three forms include a number of notable information requests that are not currently required by the SRDP process.

Perhaps most notably, the SRDP Disclosure Form requires the disclosing provider to address the “pervasiveness of noncompliance.” For purposes of the SRDP, pervasiveness means how common or frequent the disclosed noncompliance was in comparison with similar financial relationships between the disclosing party and physicians. Additionally, the disclosing party must address the methodology used to determine pervasiveness; and, if the provider wishes, any additional details and context to help CMS evaluate the pervasiveness of the non-compliance. Within the SRDP Disclosure Form, CMS includes a number of examples to help guide providers in responding to its pervasiveness inquiry. Examples include:

• The hospital has numerous compensation arrangements with physicians. We estimate that the noncompliant compensation arrangements disclosed herein represent less than 3 percent of all financial relationships with physicians.
• The physician practice provided nonmonetary compensation to 50 referring physicians who were not part of the physician practice during calendar year 2015. The physician practice exceeded the annual limit on nonmonetary compensation with respect to two physicians. Neither physician returned the excess nonmonetary compensation during the period established at [42 C.F.R.] § 411.357(k)(3).⁶

CMS also gave specific guidance related to application of the “stand in the shoes” provisions at 42 C.F.R. § 411.354(c) and violations arising from failure to qualify as a group practice, as the term is defined at 42 C.F.R. § 411.352. Providers may find that this guidance expands the number of financial arrangements that must be analyzed and disclosed.

CMS noted that if a compensation arrangement exists with a physician organization, the arrangement is deemed to have been an arrangement with all physicians that stand in the shoes of the physician organization. For example, if the noncompliant arrangement involves a physician organization consisting of three owners, it would count as three arrangements because the physician organization is deemed to be an arrangement with all physicians standing in the shoes of the organization.

If the disclosed noncompliance involves the failure of a physician organization to meet the group practice definition, the financial arrangements should not be reported as potential violations of the group practice requirements. Instead, all financial arrangements involving physicians in the purported group practice must be analyzed under exceptions involving both ownership or investment interests⁷ and compensation arrangements.⁸

A separate Physician Information Form must be submitted for each physician included in the disclosure. Each Physician Information Form must include a tally of the total number of noncompliant compensation and ownership/investment arrangements and address and analyze each of those arrangements. This analysis must include a narrative explanation addressing the nature of the noncompliant arrangement and a narrative describing how the arrangement was brought back into compliance or otherwise terminated. The Physician Information Form provides a list of factors that must be addressed for each type of noncompliance (services exception noncompliance, compensation, and/or ownership/investment).

The Financial Analysis Worksheet requires that the disclosing party provide a financial analysis of the potential overpayment based on the 6-year lookback period. Unlike the current SRDP, unless otherwise requested by CMS, disclosing parties are not required to report the amount of remuneration between the parties. The spreadsheet also must include a text box describing the methodology used to set forth the overpayment including whether estimates were used, and, if so, how they were calculated. By way of example, the Financial Analysis Worksheet must be submitted in Excel-compatible format and should include the following information:

Finally, if, after the disclosure is made to CMS, the disclosing party files for bankruptcy, undergoes a change of ownership or changes the designated representative, the disclosing party must inform CMS of the changes within 30 days.

The revised SRDP form provides a more standardized process and brings some clarity on CMS’ expectations for the information needed to resolve a self-disclosure. However, it will likely prove more burdensome for disclosing providers due to the detailed information required for the form’s completion. Providers disclosing arrangements involving physicians “standing in the shoes” of their physician organizations or situations where the organization fails to meet the group practice definition will particularly be faced with additional analysis and compilation of information to complete the proposed form. After the information is compiled, however, this standardized process may allow CMS to conduct a more expeditious review of self-disclosures and lead to a quicker resolution, which would be welcome by providers in the self-disclosure process.

Interested parties should review the proposed SRDP revisions carefully and submit comments by July 5, 2016.

¹ 81 Fed. Reg. 27452 (May 6, 2016).
² 42 U.S.C. § 1395nn.
³ See https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/Self-Referral-Disclosure-Protocol-Settlements.html.
⁴ 81 Fed. Reg. 7673 (Feb. 12, 2016). See also http://www.bassberry.com/publications/2016/02/cms-releases-final-rule-for-overpayments.
⁵ The cover letter is optional and may include information believed to be relevant to CMS’ evaluation of the disclosure. The forms are listed as CMS-10328.
⁶ Additional examples provided on SRDP Disclosure Form – CMS 10328.
⁷42 C.F.R. §411.356.
⁸42 C.F.R. §411.357.