We advise on compliance with 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), and state health care fraud and other criminal statutes. Our services include field testing of compliance plan design and operation to spot and correct issues before regulators arrive, as well as representation in internal and federal and state investigations.
We counsel on billing, reimbursement, and claims issues, including issues under Medicare Parts A, B, and D, Medicaid, and commercial payor requirements. We advise on regulatory issues impacting commercial health care transactions as well as those affecting members in the medical and pharmaceutical supply chains, including pharmaceutical and medical device manufacturers and suppliers, hospitals, physicians, GPOs, outsourcing companies, and other providers.
We also 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.
We advise on compliance with the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology for Economic and Clinical Health Act (HITECH), the European Union Data Protection Directive, state laws regarding privacy of health information, FDA regulations and guidance on the use of scientific and medical data, and Federal Trade Commission and Federal Communications Commission regulations related to data usage.
Health care providers must comply with numerous, ever-changing licensure and certification requirements pertaining to the health care organization itself and its licensed staff. For example, state certificate of public need (COPN) laws require regulatory approval for new programs and services or for expansion of existing programs and services, and Medicare certification rules can affect how deals are structured or delay entire projects. As such, compliance is critical and often impacts day-to-day operations, the development of new and existing facilities, and a range of corporate transactions.
The evaluation and negotiation of all types of contracts, including supply and purchase contracts, technology acquisition agreements, group purchasing agreements, outsourcing agreements, distribution agreements, logistics agreements, sales agreements, licensing agreements, leases and other facility agreements, and a wide array of other contracts, has been the bedrock of our commercial practice for decades. Our health care supply chain counseling combines that institutional knowledge and experience with our deep understanding of the regulations and market forces impacting health care businesses, including issues involving pricing, discounts, and rebates, and compliance with the Stark Law, the federal Anti-Kickback Statute, other fraud and abuse regulations, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and other regulations affecting life sciences/health care supply chain contracting.
