April 23, 2019

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New Voluntary Self-Referral Disclosure Protocol Announced

Beginning June 1, 2017, health care providers and suppliers who wish to voluntarily disclose actual or potential violations of the Stark Law must follow the new process recently finalized by the Centers for Medicare and Medicaid Services (CMS).

The Stark Law prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare or Medicaid to an entity with which the physician, or an immediate family member, has a financial relationship, unless an exception applies. The Stark Law also prohibits billing for DHS provided as a result of a prohibited referral. The 2010 Patient Protection and Affordable Care Act (ACA) required the Department of Health and Human Services (HHS) to establish a self-referral disclosure protocol (SRDP) to set forth a process for health care providers and suppliers to voluntarily self-disclose actual or potential violations of the Stark Law.

Previously, health care providers and suppliers submitted self-disclosures of actual or potential Stark violations to CMS via letter. Beginning June 1, 2017, providers and suppliers must submit all information necessary for CMS to analyze the actual or potential Stark violation via a new collection instrument (Form CMS-10328), which includes a SRDP Disclosure Form, a Physician Information Form for each physician included in the disclosure, a Financial Analysis Worksheet, and a certification. Disclosing parties are permitted to submit an optional cover letter with any additional information the party believes may be relevant to CMS’s review. The SRDP and the required forms are located here.

It’s worth noting the new SRDP does not apply to physician-owned hospitals, which are required to continue reporting noncompliant conduct via a separate process, available here. Additionally, health care providers and suppliers who wish to self-report actual or potential fraud unrelated to the Stark Law should continue to use the self disclosure protocol set forth by the HHS Office of the Inspector General (OIG) at https://oig.hhs.gov/compliance/self-disclosure-info/protocol.asp.

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Sarah C. Persinger PharmD RPh, managed care lawyer & pharmacy benefits management attorney at Dinsmore Law Firm
Associate

Sarah is a member of our Health Care Practice Group. She holds a Doctor of Pharmacy degree and is a registered pharmacist with extensive pharmacy practice experience and a working knowledge of regulatory affairs. She has managed health system pharmacy compliance with Ohio State Board of Pharmacy, DEA, and CMS regulations, the federal 340B Drug Discount Program, USP 797 and FDA Sterile Compounding requirements, and Joint Commission and HFAP Accreditation standards. 

Sarah has a strong working knowledge of specialty pharmacy, managed care and...

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Thomas Hess, health care industry attorney, Dinsmore Shohl, law firm
Partner

Annually appearing on The Best Lawyers in America list, as well as the Ohio Super Lawyers list, Tom has over 30 years of experience representing health care providers before state, federal and administrative courts across the country. He is the Practice Group Leader for the Government Relations and Health Law Practice Groups.

Leveraging extensive experience with a thorough understanding of the issues facing the health care industry, Tom takes a practical, yet aggressive approach to help clients meet their needs while also mitigating risk. Within the constantly-evolving industry, Tom guides clients through myriad challenges, including certificate of need, health care fraud and licensure investigation issues, as well as issues related to Medicare and Medicaid audits, overpayments, certifications and reimbursement. Additionally, he also has assisted clients with the acquisition and disposition of health care facilities and practices, demonstrating a knowledge of not only the industry’s distinctive operations, but also of traditional business transactions. Understanding that complex health care reform initiatives and an unstable economy have dramatically impacted the industry’s operations, Tom, a former Assistant Attorney General in Ohio, utilizes his familiarity with the regulatory agencies and their procedures to provide clients with the insight they need to confidently move forward.

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