In recent months, the United States Centers for Medicare and Medicaid Services (CMS) made changes and provided clarifications on the Stark Law. The agency created new forms under the Stark Law Voluntary Self-Referral Disclosure Protocol (SRDP) and streamlined the voluntary self-disclosure process for certain parties. CMS also revised its process for updating its Stark Law code list.
Changes to SRDP
Providers are able to self-disclose noncompliance with the Stark Law and receive reduced penalties for the noncompliance. Importantly, a disclosing party should only use the SRDP if they intend to resolve its overpayment liability exposure for the identified conduct. In 2017, CMS required specific forms and a worksheet when an entity self-disclosed noncompliance. In December 2022, CMS revised the SRDP to better streamline the disclosure process for physician group practices and entities that are disclosing multiple financial relationships with physicians when the physician is “standing in the shoes” of the physician organization.
The revised SRDP has a new Group Practice Form that allows physician group practices to report noncompliance with the requirement to qualify as a group practice. Previously a physician practice that was reporting noncompliance with the group practice requirements had to complete a physician information form for each individual physician of the practice who made prohibited referrals to the practice, even when the noncompliance was similar or identical amongst physicians.
The Group Practice form also requires groups to now disclose the “approximate date that the party discovered the actual or potential noncompliance.” This change is also made in the updated Physician Information Form template, though the financial analysis worksheet instructions require the disclosure of the “date that the overpayment associated with the physician was identified.”
Additionally, CMS now requires a financial worksheet be submitted by physician groups with each physician’s name, national provider identifier, relationship to the group (owner, employee, contractor), a statement of whether the individual physician received compensation inconsistent with the group practice requirements, and a description of any periods of noncompliance. This must be submitted in Excel format in a non-editable manner.
CMS also changed the format of certification statements. Previously, signed wet signature certification statements had to be mailed to CMS’ Division of Technical Payment Policy, in addition to the electronic filing. Now, however, CMS will allow disclosing parties to submit electronic certification statements with the SRDP.
Requirements as of March 1, 2023
Therefore, for disclosure of noncompliance arising from the failure of a physician practice to properly qualify as a group practice, the self-disclosure must include the following: the SRDP Disclosure Form; the Group Practice Information Form; a financial analysis worksheet; and a certification, either mailed or electronic.
For all other types of noncompliance disclosure, the self-disclosure must include: the SRDP Disclosure Form; Physicians Information Form(s); a financial analysis worksheet; and a certification, either mailed or electronic.
Changes to the Code List
CMS typically expects providers and suppliers to know which services are designated health services (DHS) under the Stark Law. However, the Code List only covers four designated health services categories and incorporates entire ranges of code by reference, leading physician practices to potentially miss either a range of codes or wrongly flag non-DHS codes.
For Calendar Year 2023, CMS made changes to the 2022 Code List, including adding several clinical laboratory HCPCS codes, radiology codes, and radiation therapy codes. CMS also removed some codes, including two codes associated with mammography imaging.
In the future, CMS will continue to publish annual updates to the Code List, but the updates will only be made on the Code List website. These changes will be posted on or before December 2 of each year for the following calendar year.