New Medicare Billing Rules for Off-Campus Provider-Based Departments: Best Practices for Planning and Implementation

Ms. DeBra advises clients on compliance with the physician self-referral law (the Stark Law) and the Anti-Kickback Statute (AKS), as well as similar state “mini-Stark” and “mini-kickback” laws. She also works with the firm's transaction attorneys to provide analysis and guidance on Stark Law and AKS matters when physician compensation and other potential compliance issues arise in the context of due diligence of a transaction. Ms. DeBra helps health care providers navigate the Stark Law value-based exceptions and AKS value-based safe harbors to develop compliant, high-impact arrangements. She also collaborates with providers to conduct compliance and billing audits and internal investigations. When an investigation finds potential violations of law, she advises on the best route to resolve the identified issue. As appropriate, she prepares overpayment refunds to be submitted to the Medicare administrative contractor and Medicaid agency, as well as voluntary disclosures to the U.S. Attorney’s Office, U.S. HHS OIG, or CMS. Ms. DeBra also advises clients on the Medicare provider-based rules and how they apply to hospitals. Clients rely on her to help them implement corporate integrity agreements, create new compliance policies and procedures, and conduct compliance program effectiveness reviews and gap analyses to review existing compliance programs for consistency with OIG general compliance program guidance, industry segment-specific compliance program guidance, and industry best practices. She has defended health care providers in sealed qui tam cases, including developing defense strategies and leading settlement discussions with the U.S. DOJ. 

Mr. Johnston regularly counsels clients on a wide range of reimbursement issues, including Medicare cost report issues and appeals and provider-based compliance and opportunities. He also guides clients on all aspects of 340B drug program compliance and management, pharmacy compliance and operations, provider and supplier enrollment and enforcement issues and appeals, change of ownership transactions and implementation, and long-term care transactions and certificates of need. Mr. Johnston’s clients include hospitals, health systems, pharmacies, Federally Qualified Health Centers (FQHCs), Rural Health Centers, long-term care providers, and numerous other types of health care facilities. In addition, home health and behavioral health providers and durable medical equipment companies seek David’s advice on optimizing their compliance and operations.

Mr. Killworth helps hospitals and health care facilities navigate federal and state regulatory issues. Health care providers seek his counsel on a variety of survey, certification, and licensure issues. Mr. Killworth helps clients prepare for and respond to surveys, drafts plans of correction, and appeals adverse determinations. Clients also look to Mr. Killworth for advice on provider enrollment and regulatory issues related to initial organization, changes of ownership, and mergers and acquisitions of health care entities. Additionally, he assists providers with a wide range of HIPAA privacy and security issues, including full and focused audits, breach investigations, assistance with OCR compliance investigations, policy drafting and implementation, and workforce training. Mr. Killworth is a frequent author and lecturer on health law issues.