Stark Law Compliance: Unanswered questions, pitfalls, and black holes

Gadi Weinreich | Dentons

Gadi is one of the nation’s more experienced and sought-after health care fraud and abuse and regulatory compliance lawyers, garnering tier one recognition from Chambers USA for the past nine years. Clients have described him as “brilliant” and “creative,” “a deep strategic thinker who is results-focused” and “a tremendous problem solver.” His unrelenting commitment to his client’s success also has earned him accolades in The Legal 500, SuperLawyers and from BTI Consulting Group, among others.

Gadi has 35 years of experience representing hospitals, health systems, academic medical centers, and other facilities (e.g., ASCs); pharmaceutical (including vaccine) developers and manufacturers, medical device and durable medical equipment (DME) manufacturers and suppliers, faculty practice plans and physician medical practices, group purchasing organizations, accountable care organizations (ACOs), managed care organizations, private equity and information technology companies in a wide variety of matters.

Experience

• Defending litigation and investigations involving the False Claims Act, including qui tam/whistleblower claims, and other health care and insurance fraud enforcement actions
• Representing clients in connection with congressional and executive branch (e.g., DOJ, HHS-OIG) hearings, subpoenas, civil investigative demands, audits and investigations
• Counseling on compliance with federal and state anti-kickback and physician self-referral prohibitions, including the Physician Self-Referral Law (Stark Law), Anti-Kickback Statute (AKS) and Beneficiary Inducement CMPs; provider-based department requirements; hospital “under arrangement” rules; and a host of other Medicare and Medicaid rules, regulations, manuals, orders, sub-regulatory policies and guidance relating to coverage, reimbursement, pricing (including discounts, rebates and other things of value), marketing and sales
• Advising with respect to strategic planning and geographic expansion, organizational and regulatory structure and operations, including mergers and acquisitions, stock and asset acquisitions, joint operating agreements, joint ventures, strategic alliances and affiliations, outreach networks and programs, and other corporate transactions
• Counseling regarding a host of strategic and operational initiatives, including clinical integration, co-management, physician recruitment, and telemedicine arrangements with an emphasis of compliant physician compensation methodologies

Assisting in negotiating and monitoring corporate compliance and integrity programs and agreements, and in effectuating voluntary disclosures to government authorities.

Christopher Janney | Dentons

Christopher Janney is a partner in the Health Care practice and the Life Sciences practice, resident in the Washington, DC, office. A former practice chair, Christopher has more than 30 years of experience representing hospitals, health systems, academic medical centers, pharmaceutical, vaccine and device manufacturers, durable medical equipment suppliers, group purchasing organizations, accountable care organizations, payers and information technology companies in connection with:

• Structuring complex business and clinical arrangements—including
  mergers, acquisitions and agreements pertaining to services, products, marketing, recruiting and other areas—to ensure compliance with federal and state laws
• Advising on anti-kickback, physician self-referral, civil monetary penalty and similar laws
• Developing and implementing health care fraud and abuse programs and corporate compliance programs
• Managing internal investigations and audits relating to potential violations of civil and criminal health care fraud and abuse laws.

Representing providers in connection with investigations and audits undertaken by federal and state regulatory and enforcement agencies, including the US Department of Justice (DOJ), the US Department of Health and Human Services Office of Inspector General (HHS-OIG), the Centers for Medicare and Medicaid Services (CMS) and CMS contractors.

Samantha Groden | Dentons

Samantha Groden is a member of Dentons’ Health Care practice, focusing on health care fraud and abuse, privacy and confidentiality, and other compliance and regulatory matters.

Prior to joining Dentons, Samantha served as counsel in the Health Law Group at the University of California, Office of the President, where she focused on issues related to health care fraud and abuse, privacy, licensure, clinical research compliance and Medicare/Medi-Cal reimbursement.

Experience

• Counsels with respect to compliance with federal and state anti-kickback/anti-inducement laws, the Stark Law, the Beneficiary Inducement Law, and other Medicare and Medicaid rules and sub-regulatory policies relating to coverage, reimbursement, pricing (including discounts, rebates, and other things of value), marketing and sales
• Counsels with respect to compliance with HIPAA and state privacy laws, and regularly reviews and negotiates business associate agreements
• Assists clients in assessing and monitoring corporate compliance programs and managing the implementation of corporate integrity agreements
• Counsels regarding various operational and contractual matters, including physician employment arrangements, personal service arrangements, data sharing arrangements, and terms and conditions for rebates and other offerings by manufacturers, distributors or group purchasing organizations
• Drafts and negotiates voluntary disclosures submitted to relevant government authorities (e.g., CMS, HHS-OIG) on behalf of clients and assists with US False Claims actions and other health care enforcement actions

I. Mistakes, Disputes, and the Elusive Laws of Retroactivity | 12:00pm – 1:00pm

1. Addressing payment discrepancies and contract disputes without falling out of compliance

Break | 1:00pm – 1:10pm

II. Personally Performed (and by Whom)? | 1:10pm – 1:40pm

1. Highlighting unanswered questions surrounding the structuring of compensation based on personally performed professional services

III. Under Arrangements and Unit-Based Compensation Methodologies — Buckle up for the roller coaster ride of the 2020s | 1:40pm – 2:10pm