Healthcare Compliance, Regulation & Policy

Government oversight affects every aspect of the healthcare industry, from construction of new healthcare facilities, to payment for medical services and the buying and selling of healthcare businesses. With multiple regulatory bodies governing the healthcare industry at state and federal levels — often with overlapping authority — providers, investors and healthcare service providers must juggle numerous, constantly changing regulations and policies.

McGuireWoods’ attorneys have the knowledge and experience healthcare providers need to assess and achieve compliance with federal and state-specific regulatory requirements. This group of more than 53 healthcare-focused attorneys advises clients on a range of regulatory and policy issues, including:

Federal and state anti-kickback and fraud and abuse laws
Federal and state self-referral laws, including the federal Stark Law
Corporate practice of medicine restrictions
False Claims Act
Federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA)
Medicare and Medicaid conditions of participation
Licensing, certification and certificate of need
Restrictions on patient transfers, including the federal Emergency Medical Treatment and Active Labor Act (EMTALA)
Health Care Quality Improvement Act
Patient consent issues
U.S. Food and Drug Administration regulations
No Surprises Act
Section 1557
Eliminating Kickbacks in Recovery Act

McGuireWoods takes full advantage of the firm’s national network of 20 offices to advise clients on compliance with local, state and federal regulations in jurisdictions throughout the United States. Given the rate of change and level of uncertainty in this highly regulated industry, we update our clients regularly on national and local trends and pending legislation via frequent client alerts, newsletters and blogs, including The Healthcare Investor and The FCA Insider.

Representative matters include:

Submission of Stark Law self-disclosures
Submission of Office of Inspector General (OIG) self-disclosures
Development of compliance programs, policies and procedures and associated training
Negotiation of co-management agreements
Evaluation of group practice compensation models for Stark Law compliance
Change-of-ownership filings to various licensing and certification boards
Healthcare diligence and the evaluation of healthcare providers for regulatory compliance
Development of Surprise Billing policies, procedures and notifications
Submission of OIG advisory opinions and Medicare reimbursement claim appeals