Industries & Practices

Health Care Regulatory

Health system and physician-owned hospital affiliation

Prepared several options for a health system and physician-owned surgical hospital to affiliate in a secondary market. Provided regulatory advice, including an analysis of potential Stark Law and Anti-Kickback Statute compliance issues, as well as antitrust and federal tax law advice.

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Change of Ownership RAP appeal

Represented a home health agency in its appeal of post-Medicare Change of Ownership Request for Anticipated Payment suspension imposed by the Centers for Medicare and Medicaid Services. Successfully appealed the payment suspension, which was worth $15 million.

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Behavioral health provider counseling

Represent a variety of behavioral health providers in state licensure matters as well as general operational and compliance matters.

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Testimony before the Ohio House Health Committee

Gave testimony before the Ohio House of Representatives Health Committee on behalf of a state-level hospital association regarding medical record contents (H.B. 172).

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Provider-based attestations

Prepared successful provider-based and mid-build attestations for a hospital system regarding an off-campus, provider-based department and counseled the client through the process.

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340B self-disclosure

Managed and successfully negotiated self-disclosure by a 340B covered entity to multiple drug manufacturers and the Health Resources Services Administration.

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340B Program contract negotiations

Drafted and negotiated pharmacy services agreement and contract pharmacy agreements on behalf of a hospital system with national pharmacy providers.

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False Claims Act Supreme Court amicus brief

Drafted and filed an amicus brief on behalf of a managed care organization in an important False Claims Act case pending before the U.S. Supreme Court. The issues before the Court were whether and how the so-called “implied false certification theory” can be a basis for liability under the False Claims Act. The firm prepared an amicus brief on behalf of our client, which was very well received both by the client and petitioner’s counsel.   

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Amicus in support of HHS interpretive rule

Prepared an amicus brief on behalf of the American Hospital Association in support of the U.S. Department of Health and Human Services (HHS) interpretive rule providing guidance on the scope of the exclusion of orphan drugs from 340B discounts. 

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Health care information database

Assisted in the development of a state-wide database for health care information reports, including the creation of policies and agreements and compliance with regulatory requirements (including HIPAA). Also worked to revise protocols for state-to-state relationships, the sharing of data and related data sharing agreements.

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System-wide electronic medical record system

Assisted a large health system with the system-wide implementation of an electronic health records (EHR) system, ensuring legal and regulatory compliance, HIPAA security and continuity of patient care. 

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County hospital affiliation

Represented a county hospital that became affiliated with a large health care system, obtaining all regulatory approvals, overseeing self-disclosure of potential Stark issues and assisting with the payoff of outstanding bonds.

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