Healthcare Compliance, Regulatory & Policy

We are a resource for structuring deals, launching new ventures, responding to audits and investigations, and mitigating enforcement risks —anticipating regulatory hurdles, developing solutions, and offering practical, business-focused strategies to keep clients compliant while advancing their goals.

With multiple regulatory bodies governing the healthcare sector at the state and federal levels, healthcare industry participants must juggle sometimes ambiguous, often conflicting, regulations and policies. The firm’s nationwide team of attorneys works across 20 offices to provide clients with boots-on-the-ground advocacy for complying with local, state and federal regulations in jurisdictions throughout the United States. Our lawyers provide updates on national and local regulatory trends and pending legislation via compliance training and other educational resources, client alerts, newsletters and blogs, including McGuireWoods’ The FCA Insider and Healthcare Pre-Transaction Notices/Consents page.

How We Help

McGuireWoods advises clients on regulatory and policy issues, including:

• state and federal anti-kickback and fraud and abuse laws;
• state and federal self-referral laws, including the federal Stark Law;
• False Claims Act (FCA);
• federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA);
• corporate practice doctrines applicable to professionals, including medicine, dentistry, and nursing;
• Medicare and Medicaid conditions of participation;
• Medicare & Medicaid coverage and reimbursement issues;
• licensing, certification, and certificate of need;
• state transaction reporting requirements;
• restrictions on patient transfers, including the federal Emergency Medical Treatment and Active Labor Act (EMTALA);
• Health Care Quality Improvement Act (HCQIA);
• patient notice and consent issues;
• Federal Food, Drug, and Cosmetic Act (FDCA) and other U.S. Food and Drug Administration regulations;
• No Surprises Act;
• Section 1557 Nondiscrimination Rules; and
• Eliminating Kickbacks in Recovery Act (EKRA).

Attorneys advise on regulatory matters that arise during audits, investigations and enforcement proceedings initiated by federal and state agencies, including:

• Centers for Medicare & Medicaid Services (CMS);
• Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS-OIG);
• U.S. Department of Justice (DOJ);
• Office for Civil Rights (OCR);
• FDA;
• state health departments;
• state professional licensing boards; and
• state attorneys general.

We also counsel participants in the healthcare and life sciences industries, including healthcare providers and medical device and pharmaceutical manufacturers, on compliance matters such as:

• establishing compliance programs;
• adopting policies and procedures ;
• compliance training;
• resolving compliance reports and investigations; and
• structuring prophylactic measures to avoid scrutiny.

Representative Experience

• Submit Stark Law self-referral protocol disclosures to CMS;
• submit fraud and abuse self-disclosures to OIG;
• respond to government subpoenas, document requests and civil investigation demands;
• negotiate co-management agreements, physician service agreements and other strategic arrangements;
• evaluate group practice compensation models for Stark Law compliance;
• submit change-of-ownership filings, including premerger state filings, to licensing and certification bodies;
• perform healthcare diligence and evaluate healthcare providers for regulatory compliance;
• obtain favorable advisory opinions from OIG and CMS; and
• appeal Medicare reimbursement claim denials or recoupment requests.