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.

Patents

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