Participants in the health and life sciences industries face an unmatched tangle of laws and regulations that can impede useful innovations in the delivery of care. We provide solutions for health care providers, companies, and investors on how to manage this tangle.
Our services include advising clients on regulatory and operational compliance issues, reimbursement, contracting, administrative licensing defense, and representing health care clients in commercial litigation matters. Whether you are a start-up with little more than an idea, a multi-practice health system, or an international health care conglomerate, we can help you find new and effective ways to deliver health care within the industry’s regulatory constraints.
General and Transactional Healthcare Regulatory Advice:
- Guiding clients in compliance with federal Stark, and federal and state Anti-Kickback, and False Claims Act laws and regulations.
- Advising clients on compliance with health privacy and security laws including HIPAA and its state law counterparts.
- Drafting policies and procedures relating to numerous operational aspects of the health industry, including without limitation, telemedicine, recordkeeping, informed consent, adverse event tracking and disclosure, and electronic medical records management.
- Assisting in the wind-down of health facilities, including change of ownership and licenses and disposition of assets.
- Assisting clients with health care financing transactions involving Medicare and Medicaid payments.
- Representing all disciplines of health care providers before professional licensing boards, including Pharmacy Boards, Medical Boards, Nursing Boards, Boards of Chiropractic Examiners, and state Departments of Health Services.
- Obtain variances for clients from regulatory requirements that interfere with business opportunities.
Health Facilities and Healthcare Systems:
- Advising on health facility start-up, including the preparation and review of governance documents, bylaws, license applications, policies and procedures, privileging and credentialing criteria, and other operational requirements.
- Preparing root cause analyses and reporting adverse events.
- Advising Medical Executive Committees on provider disciplinary and peer review matters.
- Advising clients regarding conditions of participation in Medicare and Medicaid programs.
- Counseling client through internal investigation of potential billing fraud.
- Advise on regulatory aspects of court-appointed receivers.
Reimbursement and Payment:
- Defending clients in qui tam challenges to drug pricing and reporting.
- Representing hospitals, behavioral health providers, and pharmacy chains in administrative and federal appellate challenges to Medicare (Parts A, C, and D) and state Medicaid reimbursement.
- Advising Pharmacies and Pharmacy Benefits Management companies on a range of issues, including state licensure requirements, network size and access, drug pricing, and service contracts.
- Advising drug manufacturers on rebate and discount compliance, reporting, and management.
- Drafting, revising, and advising on network participation agreements for pharmacy chains with commercial, Part D, and Medicaid plans.
- Training manufacturer leadership on compliant contracting and network management for launch of specialty oncology drug.
- Assisting clients (manufacturers, pharmacies, PBMS, and call centers) on HUB development and management of specialty drug adherence programs.
Pharmacy Practice and Compliance:
- Negotiating contracts for the marketing, sale, and ongoing monitoring of specialty drugs.
- Serving as National Coordinating Counsel to large pharmacy chain on Board of Pharmacy regulatory and enforcement issues.
- Identifying market opportunities for a large pharmacy chain with respect to its PBM and Medicare Part D agreements.
- Providing legal support in the development of a national pharmacy prescription data management and e-prescribing system.
- Advising national pharmacy chains on DEA and state-specific restrictions on the sale of controlled substances.
- Assisting manufacturers and specialty pharmacies on compliance with federally-mandated REMS programs.
- Advise compounding pharmacies on anticipatory compounds and office-based administration issues.
- Advising retailers on acceptable promotional practices for pharmacy sales.
- Advising on complex multistate pharmacy operational matters to comply with non-resident pharmacy laws.
- Developing processes for central fill and shared services pharmacy practice.
Drug and Device Marketing and Distribution Compliance:
- Counseling medical device and mobile medical application developers on registration, listing, and 510K clearance.
- Advising clients on manufacturing policies, procedures and processes to achieve compliance with cGMPs, as well as drafting and reviewing quality agreements on behalf of manufacturers and contract manufacturers.
- Assisting manufacturers with FDA inspections and responding to FDA Form 483 observations.
- Advising manufacturers and repackagers on state licensure and labeling requirements.
- Training drug marketing representatives and management on compliance with the PhRMA Code of Ethics, FDA, and state law restraints on promotion.
- Drafting and revising manufacturer marketing policies and procedures.
- Reviewing marketing claims against regulatory standards to ensure product is appropriately categorized as a nutriceutical vs. a drug.
- Advising clients on state and federal law warning label requirements.
- Advising clients on state distribution and registration requirements, including pedigree compliance for non-routine distribution channels.
- Consulting on distribution and rebate agreements.
- Assisting wholesalers with FDA and state law inspections and responding to FDA Form 483 observations.
- Advising wholesalers on state licensure requirements.
- Defending prescription drug wholesaler in DEA investigation of product security and inventory controls.
We prepare and prosecute U.S. and foreign patent applications and routinely counsel our clients on patent-related issues and strategies. Among other technology areas, we prosecute patents related to:
- Software applications
- Wireless applications
- Wireless content development systems
- Medical systems and devices
- Content searching algorithms and systems
- Compression-decompression algorithms
- Applications and web-based business systems
- Consumer products