OFW Law’s Health Industry Policy and Regulatory Practice works to provide high quality substantive legal and regulatory advice and combines that work with skilled advocacy on behalf of clients to government policymakers. The professionals of the health industry practice advise and work on behalf of clients in the health care delivery system area and medical products and life sciences area.
In the health care delivery system area, OFW represents large physician practices, integrated health systems, medical societies, business associates and payer organizations. We assist health care entities in understanding and complying with various Medicare and Medicaid regulations, and are particularly active in legislative and regulatory policy advocacy when clients seek to improve underlying statutory and regulatory policy and executive branch interpretations. OFW professionals are deeply engaged in the area of health reform, having represented clients in the creation and implementation of the Affordable Care Act (ACA), and now the ongoing effort to repeal and replace that legislation. Some specific areas of expertise, include:
- Payment reform, including the Quality Payment Program, various value-based payment programs, alternative payment models (APMs), and the Center for Medicare and Medicaid Innovation (CMMI);
- Appropriate uses and disclosures of Protected Health Information under federal laws implemented and enforced by the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR);
- Compliance with federal laws and regulations prohibiting health care fraud and abuse, including the Anti-Kickback Statute and Civil Money Penalty Law (a.k.a. the “Beneficiary Inducement Statute”);
- Medicare and Medicaid coverage and reimbursement;
- Health care-related fraud, abuse and compliance;
- Health care regulatory compliance and counseling;
- Counseling and due diligence in health care corporate transactions
In the medical products and life sciences areas, we represent clients that manufacture, distribute, and dispense medical products. Representative clients range from major bio-pharmaceutical manufacturers, to early-stage biopharmaceutical companies, and medical device and diagnostic manufacturers. In this area, we help clients navigate policy and regulation through the FDA-approval process, and then assist with payment and coverage-related issues once the approval has occurred. Some specific areas of expertise, include:
- The Federal Food, Drug, and Cosmetic Act and the Public Health Service Act;
- Medicare and Medicaid coverage;
- Medical product supply chain integrity and traceability;
- Clinical trials and clinical investigators, including compliance with FDA and HHS requirements; and
- Compliance with the Drug Enforcement Administration (DEA) requirements for the manufacture and distribution of controlled substances and listed chemicals.
We invite you to read more about our Health Care practice by following the links to our related practice areas. For more information about our services, please contact Ladd Wiley, Chairman of the Health Industry Practice, at (202) 549-3595 or firstname.lastname@example.org