September 23, 2010, CMS released its Voluntary Self-Referral Disclosure Protocol (“SRDP”), as required by Section 6409 of the Patient Protection and Affordable Care Act (“PPACA”). The PPACA requires that the Secretary of the Department of Health and Human Services establish protocol for healthcare providers and suppliers to disclose actual or potential violations of Section 1877 of the Social Security Act (commonly known as the Stark Act). Under the Stark Act, healthcare providers and suppliers may not refer patients to any entity for certain services if the physician has a financial relationship with the entity, unless an exception for such referral applies.
The SRDP is available to all health care providers of services or suppliers, regardless of whether they are individuals or entities, and is not limited to any particular industry, medical specialty or type of service. The SRDP provides guidelines and a process for health care providers and suppliers to self-report actual or potential violations of the Stark Act in exchange for potentially (although not guaranteed) more lenient and less formal settlement proceedings.
The SRDP is a tedious process involving careful legal and financial analysis of a provider or supplier’s business. Providers and suppliers should be cautious in self-disclosure to avoid waiving future appeal rights or reporting conduct which may raise potential liability for violations of other federal criminal, civil or administrative laws. Providers and suppliers are urged to seek legal counsel if an inappropriate referral or Stark Act violation has occurred to determine the most appropriate course of action.
For more information on the SRDP process or how to address potential Stark Act violations, please contact Jill Shotzberger at jsberger@jeylaw.com or (404) 995-6792.
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