James

By Alyssa James

Recently, the Centers for Medicare and Medicaid Services (CMS), finalized a new set of forms intended to streamline and simplify the voluntary Self-Referral Disclosure Protocol (SRDP) process available to providers for the disclosure of potential violations of the Stark Law. The original protocol was created because of the Affordable Care Act and published in September 2010.

CMS proposed the usage of the new form in May 2016 citing a need to “reduce the burden on disclosing parties by reducing the amount of information…required for submissions to the SRDP.” Having received no comments, CMS published the final form on March 28, 2017 (SRDP Form).

A copy of the new SRDP Form is available at https://goo.gl/RHxSxE. Effective June 1, 2017, the SRDP Form is mandatory when disclosing potential or actual violations of the physician self-referral statute commonly known as the Stark Law. While the new SRDP Form simplifies the process in certain aspects, challenges remain.

Changes and Challenges

The new SRDP Form provides CMS and healthcare providers a standardized means of disclosing potential or actual Stark violations. Under the updated SRDP process, disclosing parties must include in every disclosure:

• A completed SRDP disclosure form.
• A physician information form for each physician arrangement.
• A financial analysis worksheet.
• A certification verifying the accuracy and truthfulness of the information submitted in the disclosure.

While the new SRDP process requires disclosing information in a different and potentially more detailed format, the information requested is like that which was required under the prior SRDP. However, there are a few key changes highlighted below that may present challenges for healthcare providers in assembling the necessary information required to complete the SRDP Form.

Pervasiveness of Noncompliance

The updated SRDP Form requires providers to identify the pervasiveness of noncompliance as part of the disclosure process to CMS. For purposes of SRDP, pervasiveness means how common or frequent the disclosed noncompliance was in comparison with similar financial relationships between the disclosing party and physicians.

Providers may report based on the type of noncompliance (i.e. lease arrangements) or in the aggregate, but they must explain how the calculations were determined. CMS states the pervasiveness question should be answered with a quantitative analysis and provides examples of this analysis within the SRDP Form. Depending upon the size of the organization, identifying all the financial arrangements during the applicable look back period may pose challenges.

Additionally, there may be several ways of presenting the information when demonstrating pervasiveness. Although CMS does not provide details on how proposed settlements are calculated under the SRDP, it is possible that pervasiveness will be considered as a factor when determining settlement amounts.

Physician Information Form

The new SRDP Form includes a Physician Information Form (PIF) that discloses each physician involved in the noncompliant arrangement. While prior CMS disclosures required identification of the physician group involved, CMS now requires that a separate PIF must be completed for any physician that stand in the shoes of the physician’s organization. The PIF must include, among other details:

• An explanation of the arrangement.
• Information regarding the rate of compensation or the amount of remuneration provided under the problematic arrangement.
• The date of discovery of the potentially un-compliant arrangement.

Identifying the specific physicians that stand in the shoes may present challenges because this information is rarely publicly available and healthcare entities often contract with physician groups but may not have specific information regarding ownership structures or individual physician owners. Explicit identification of the date of discovery of the potentially non-compliant arrangement may also have implications for disclosing entities as this information may implicate the 60-day over-payment rule.

Financial Analysis Worksheet

Disclosing providers must also submit a financial analysis worksheet of the potential overpayments received (based on a lookback period of six years). The financial analysis must be created in Microsoft Excel.

For each physician arrangement included in the disclosure, the worksheet must include:

• The physician’s name.
• The physician’s NPI.
• The date the over-payment was identified.
• The amount of reimbursement received because of the potentially non-compliant arrangement.

This format is more detailed than previous CMS requests.

Practical Takeaways

Although the new SRDP Form provides some administrative clarity for both providers and CMS, it also raises concerns regarding proper documentation and tracking of physician arrangements. The SRDP Form now requires more information regarding the facts and circumstances of the arrangement(s) than previous self-disclosures and healthcare providers should carefully review all information prior to submitting an SRDP Form to CMS.

In addition, all healthcare providers should maintain thorough and accurate records of all financial relationships with physicians and physician organizations. Due to the high stakes at risk and the complicated nature of the SRDP Form, it is highly encouraged that providers considering self-disclosure seek legal counsel for appropriate analyses and SRDP Form completion strategies.

-Alyssa James is an attorney with Hall, Render, Killian, Heath & Lyman in Indianapolis, Ind.