FDA & Healthcare

Our keen grasp of regulations and subregulatory guidance from the Centers for Medicare & Medicaid Services, including local coverage decisions and national coverage determinations, gives our clients a critical advantage in coverage and payment matters arising under Medicare, Medicaid, and other federal healthcare programs. Our services include the following:

• Advice and defense in Medicare, Medicaid, and regional contractor audits and investigations related to alleged fraud and abuse in billing and coding practices
• Representation on Medicare reimbursement appeals at the redetermination and reconsideration stages before administrative law judges, the Medicare Appeals Council, and in federal courts
• Representation of Part A providers before the Provider Reimbursement Review Board
• Guidance on appeals of Medicaid reimbursement issues at the US state level

Our healthcare team assists clients in the public policy sphere to interpret, monitor, and influence US congressional legislation, federal rules and regulations, and policies issued by the executive branch. The experience of many of our lawyers who served in government healthcare oversight agencies allows us to offer clients astute analysis of rapidly evolving developments and timely guidance on matters critical to their businesses.

We advise clients on the full spectrum of privacy and security compliance matters, including those related to the following:

• Health Insurance Portability and Accountability Act (HIPAA)
• Health Information Technology for Economic and Clinical Health (HITECH) Act
• Gramm-Leach-Bliley Act
• State security breach notification laws
• US Federal Trade Commission privacy and security standards
• State medical privacy laws
• Red Flags Rule
• International privacy rules

Our team also handles the following:

• Developing privacy and data security policies and procedures
• Structuring healthcare information technology ventures
• Responding to security breaches
• Transmitting data to state and federal healthcare agencies
• Negotiating and litigating of data breach civil penalties imposed by the US Department of Health and Human Service’s Office of Civil Rights
• Training employees on the disclosure of information and ongoing compliance monitoring
• Interpreting, monitoring, and influencing privacy and data security rules and regulations, congressional legislation, and other policies issued by the executive branch

Learn more about our Privacy & Cybersecurity team.

Cutting-edge digital health technologies are revolutionizing healthcare and helping patients in new and innovative ways. Rules impacting these digital health technologies are evolving quickly as well to guide the lawful use of these tools. Our lawyers help navigate digital health clients through CMS and FDA regulations, privacy and cybersecurity concerns, private and governmental reimbursement matters, FCC and telecommunications regulation, state licensure and scope of practice rules, intellectual property matters, and transactions related to government contracts, venture capital, financing, mergers and acquisitions, and initial public offerings (IPOs), among other matters.

We advise clients across the digital health landscape, including companies focused on the following areas:

• Artificial intelligence and machine learning
• Telehealth, telemedicine, and virtual care
• Remote patient monitoring services
• Big data and analytics
• Bioinformatics, genomics, and sequencing
• Care coordination
• Clinical decision support software
• Consumer health information portals
• Cloud computing and software-as-a-service
• Electronic medical records (EMRs)
• Internet of Things (IoT)
• Medical devices
• E-prescribing and online pharmacies
• Wearables and biosensors
• ePayments and online scheduling
• Patient engagement
• Population health management

Learn more about our Digital Health team.

Medical device law is being dramatically reconfigured in response to rapidly evolving technology. These changes affect small startups and large multinationals alike. Companies need sophisticated and experienced guidance to navigate issues related to the Center for Devices and Radiological Health.

Within this new and complicated regulatory environment, our strategic assistance at the premarket stage focuses on avoiding costs and saving time. We assist with the following:

• Section 510(k) premarket notifications
• Section 510(k) premarket notifications
• Investigational Device Exemption (IDE) submissions
• Premarket approval (PMA) applications
• Humanitarian device exemption (HDE) submissions
• Panel reviews
• Scientific disputes and appeals
• Resolution of jurisdictional uncertainties
• Device modification analyses

At the post-market stage, we help clients ensure that product marketing strategies are optimized, while compliance and other liability exposures are controlled. To maximize market potential, we provide creative promotional, reimbursement, marketing, and distribution strategies and support day-to-day compliance activities by offering technical advice on such issues as medical device reporting, cGMPs, and recalls and field corrections. We also anticipate, and seek to contain, product liability exposure.

When enforcement concerns arise, we leverage our experience with some of the largest and most complex government investigations and settlements of the last decade. As the FDA, DOJ, Health Care Financing Administration (HCFA), and the HHS’s Office of Inspector General (OIG) continue to take an aggressive enforcement stance, we help clients respond to civil and criminal enforcement and compliance actions, including the following:

• FDA Form 483 and warning letter responses
• Import/export issues
• Consent decree issues
• FDA integrity policy

Morgan Lewis counsels early-stage and mature global pharmaceutical and biotech companies from product development through the product life cycle. This includes clinical trial design, FDA regulatory approval, manufacturing and current good manufacturing practices (cGMPs), supply chain issues, promotions and marketing, pricing, and distribution. We also advise companies on the FDA and related regulatory aspects of corporate transactions, as well as government enforcement and investigations.

Our clients call on us for help in many areas, including the following:

• Advice on pharmaceutical product development pathway strategies and clinical trial design, including agreements and informed consent
• Orphan drug designations and submissions
• Investigational New Drug (IND) applications, New Drug Applications (NDAs), 505(b)(2) applications, Biologics License Applications (BLAs), 351(k) biosimilar applications, and special protocol assessments
• Patent and market exclusivity strategies, including for biosimilars
• Preparation for FDA and other advisory committee meetings
• Approval, negotiation, and dispute resolution, including for FDA complete response letters
• Risk Evaluation and Mitigation Strategies (REMS), US Drug Enforcement Administration (DEA) scheduling, and related issues
• Preparation of drug supply, quality, pharmacovigilance, and related agreements, and cGMP policies and procedures
• Advice on and resolution of cGMP inspection issues, FDA Form 483s, untitled letters, and warning letters
• Government contract pricing and enforcement matters
• Recalls, market withdrawals, and quarantines under the Drug Quality and Security Act (DQSA) and related crisis management issues
• Import and export issues

Our keen grasp of government pricing regulations and subregulatory guidance across multiple government healthcare programs gives our clients a critical advantage in staying ahead of the curve, ensuring compliance and maximizing business advantage. Our services include the following:

• Strategic counseling on emerging requirements relating to the Medicaid Drug Rebate Program, Medicare Part B and D, the 340B Program, TriCare, and the Veterans Health Care Act
• Counseling on emerging state price reporting and transparency rules
• Creation of detailed government price reporting methodologies and calculation frameworks
• Performing government pricing compliance reviews, recalculations, and voluntary disclosures
• Evaluating programs and commercial contracts relative to fraud and abuse and government price considerations

Our keen grasp of federal government procurements, government funded research and development (R&D), and government contract regulations gives our clients a critical advantage in bidding for, capturing, and successfully performing government contracts. Our services include the following:

• Advising manufacturers, resellers, startups, R&D firms, prime contractors, and subcontracts regarding emerging requirements, risks of government contracts, and strategic management of risk
• Reviewing solicitations and preparing proposals, including Federal Supply Schedule contract commercial item proposals
• Performing government contract compliance reviews
• Assisting in resolution of contract disputes, terminations, and bid protests

Morgan Lewis assists manufacturers file new dietary ingredient and 30-day market claim notices with the FDA. We also help determine the appropriateness of new or novel dietary supplement ingredients, and whether a product’s delivery mechanism affects its regulatory status. To help companies avoid more rigorous regulation, we advise clients on the types of health claims and structure and function claims that are appropriate for dietary supplements. We provide strategic, creative solutions in connection with broadcast, print, and online advertising and we help prepare defensible labeling to support claims that the supplement or food provides an enhanced function, while reducing the risk of additional FDA regulation.

We represent the full spectrum of companies that develop, market, and distribute a wide array of foods and food additives and we advise on labeling and marketing health and structure/function claims for foods. Our clients’ businesses include the following:

• Food and color additives
• Dietary supplements
• Food components
• Generally recognized as safe (GRAS) substances
• Medical foods and infant formulas
• Packaging materials
• Animal feed products
• Traditional and biotechnology-derived human and animal food additives
• Bioengineered plant derived foods

Our team assists clients with the appropriate safety assessment and submissions for food ingredients, including the following:

• Food additive petitions
• Food contact notices
• GRAS notifications and self-determinations
• Legal services supported by chemists and toxicologists to bring new food additives to market
• Product labeling and advertising issues
• FDA and state enforcement matters, including reportable food events, recalls, and import detention issues
• Hazard Analysis and Critical Control Points (HACCP)
• Hazard Analysis and Risk-Based Preventive Controls (HARPC)
• cGMP compliance issues and enforcement actions (Form 483s)
• Regulation of meat, poultry, and egg products by the USDA Food Safety and Inspection Service (FSIS) and its continuous inspection, prior label approval, and preventive food safety requirements