CMS has asked for comments on a form for healthcare providers to disclose actual or potential violations of the federal self-referral (Stark) law. The proposed format includes a disclosure form, a physician-information form, and a financial-analysis worksheet.
As many providers know, CMS is significantly backlogged with self-disclosures, and so the standard form may help the agency more speedily process self-disclosures. Although CMS anticipates that the standard form will also limit the amount of time that it takes to prepare a self-disclosure through the agency’s Self-Referral Disclosure Protocol, the proposed form expands some of the information that providers must include. And especially because CMS still permits an optional cover letter, preparing submissions under the new approach will likely require a similar amount of effort as prior submissions.
For example, on the proposed form, providers must include more information about other financial relationships about the relevant timeframe, which could take significant time to determine, to show the “pervasiveness of noncompliance.” CMS will also need to be informed within 30 days of the disclosing party’s bankruptcy filing, change of ownership, or change of designated representative. Helpfully, however, the form expressly eliminates reporting of the amount of remuneration between the parties, which previously needed to be provided with the financial analysis.
CMS will also be making changes to expand the current four-year lookback to six years based on the OIG’s final rule on overpayments, briefed in our post “CMS issues anticipated Medicare overpayments final rule; relaxes initial proposals.” Despite the agency’s relaxed rules, briefed in our coverage of the 2016 Medicare Physician Fee Schedule final rule, that may allow some providers to withdraw their submissions if they locate sufficient documentation to satisfy the elements of a Stark Law exception, the challenges of locating documentation for a six-year period to support a compliant arrangement may result in providers reporting some, if not all, of arrangements that do not satisfy all elements of an applicable exception.
CMS’s request for comments is available in the May 6 Federal Register (81 Fed. Reg. 27,450). Comments are due on July 5.