Healthcare Regulatory and Compliance

Our Healthcare Regulatory and Compliance practice combines top-tier expertise in healthcare regulatory compliance with extensive transactional experience, providing pragmatic guidance for dealmakers across the healthcare landscape.

In a highly regulated and expanding industry, the firm focuses on helping healthcare clients overcome challenges and meet their business goals. Healthcare providers and healthcare supply chain businesses operate in an industry in which conventions are constantly changing and becoming more complex. Changes in regulations and business practices bring many challenges, but also create opportunities, as legislative and regulatory actions alter the business models of insurers, providers, suppliers, and other entities that interact with providers on a number of levels.

Given the regulatory complexities inherent in healthcare transactions, firms often mitigate risks by engaging separate regulatory and transactional counsel. Goodwin offers a unique blend of healthcare regulatory proficiency — encompassing Fraud and Abuse, Anti-Kickback Statute, Stark, False Claims Act, HIPAA, licensing, certificates of need, corporate practice of medicine, and reimbursement — alongside corporate, M&A, and transactional capabilities. This comprehensive approach ensures optimal client outcomes within a single, integrated solution delivery framework.

Our healthcare clients include acute and post-acute providers and suppliers, including single and multi-specialty physician groups, PPMs, MSOs, DSOs, outpatient medical care and diagnostic centers, long-term care organizations, hospice providers, home health agencies, retail and long-term care pharmacies, specialty, combo, home infusion and long-term care, rehabilitation centers, for-profit and nonprofit hospitals and health systems, academic medical centers, ambulatory surgery centers (ASCs), specialty hospitals, research institutions and laboratories, contract research organizations (CROs), healthcare product and services suppliers, and group purchasing organizations (GPOs).

Additionally, we counsel medical device companies, pharmaceutical manufacturers, and biotechnology firms on various transactional and regulatory matters. Our services regularly include drafting and negotiating agreements throughout the healthcare supply chain, such as supply contracts, manufacturing agreements, technology contracts, logistics and outsourcing transactions, and negotiations with distribution partners, GPOs, downstream providers, and PBMs.

Regulatory pressures and changes in service delivery models are also driving the rapid development of disruptive healthcare technologies. Goodwin’s Digital Health team assists clients in adapting business strategies to meet evolving patient needs and consumer demands and ultimately improve quality of care. Our team of over 100 healthcare lawyers has extensive industry knowledge and experience, having served more than 550 digital health clients and executed deals worth over $160 billion. We leverage our deep resources in data privacy, cybersecurity, strategic collaborations, company formation, regulatory issues, patent protection, M&A transactions, IPOs, and more to serve these clients. Our digital health services cover clients engaged in businesses such as provider directories, hybrid care, digital therapeutics, billing, app development, diagnostics, clinical intelligence, home health tech, virtual care, patient engagement, and workflow automation.

Goodwin’s team includes an impressive roster of former government enforcement officials. We help our clients comply with federal and state laws governing fraud and abuse, coverage and reimbursement, privacy and security, clinical research, telemedicine, and more. We also assist them with FDA regulatory and compliance issues, from product development and approval to commercialization and transactions. Whether they are healthcare services providers, life sciences innovators, digital health disruptors, or health technology investors, we offer our clients strategic guidance and effective solutions to achieve their goals.

Fraud and Abuse Laws

Entities operating in the healthcare and pharmaceutical space increasingly are targeted by the DOJ, HHS OIG, individual U.S. Attorney’s Offices, and state attorneys general, all seeking to enforce a wide range of fraud and abuse laws, such as the False Claims Act, the Anti-Kickback Act, Medicare and Medicaid regulations, the Food, Drug and Cosmetic Act,

the Prescription Drug Marketing Act, the U.S. Foreign Corrupt Practices Act (FCPA), healthcare fraud and other criminal statutes.

To assist compliance efforts, and reduce enterprise risk for our clients, the firm also provides a consultative regulatory investigation service that conducts field testing of compliance plan design and operation, before regulators arrive. This process enables identification of misconduct (whether intentional or not) and testing of compliance effectiveness by identifying issues from a regulatory perspective, based on investigative techniques used during federal and state regulatory investigations. The consultation can identify vulnerabilities and remediation measures, such as plan and work-flow changes, and is indicative of a provider’s intent to operate appropriately.

We represent clients facing investigation and prosecution by state and federal authorities, including the U.S. Attorneys’ offices, state attorneys general and Congressional oversight committees. Our broad and deep industry experience is the cornerstone of our white collar defense and corporate investigation practice in the healthcare and pharmaceutical space.

Billing and Reimbursement

We counsel a wide range of healthcare clients and supply chain participants on billing, reimbursement and claims issues, including issues under Medicare Parts A, B and D, Medicaid and commercial payor requirements. We represent clients in dealing with regulatory issues impacting commercial healthcare transactions as well as those affecting members in the medical and pharmaceutical supply chains, including pharmaceutical medical device manufacturers and suppliers, hospitals, physicians, GPOs, outsourcing companies and other providers.

We counsel, advise and represent third-party administrators of prescription drug programs in dealing with issues of competition, regulation, and transparency, and help these purchasers carefully evaluate and structure those relationships to avoid government scrutiny.