Life Sciences and Healthcare Regulatory

Why Cooley

Our global life sciences and healthcare regulatory lawyers understand the myriad challenges and opportunities facing the healthcare and life sciences industries. In an environment of increasingly evolving laws and regulations, any company that is directly or indirectly involved with the delivery of drugs, biologics, medical devices and other healthcare products or services must consider the intricate legal and regulatory obligations relevant to its business operations. Whether providers, developers, manufacturers, suppliers, payors, technology companies or investors in this space, our team has the depth of experience necessary to navigate the ever-changing rules of this dynamic marketplace.

Areas of Practice

Fraud & Abuse

• Analyze, counsel and structure arrangements between and among referral sources for compliance with fraud and abuse laws, including state and federal anti-kickback laws, civil monetary penalties law, physician self-referral laws, False Claims Acts and related state licensure and unprofessional conduct regulations
• Assist clients with remediation efforts for fraud and abuse compliance, including advice regarding self-disclosure reporting obligations
  
• Respond to administrative, civil, criminal and grand jury subpoenas, Congressional inquiries and agency audits and notices
• Defend False Claims Act actions arising from allegations of patient safety and research misconduct, manufacturing deficiencies, other Food, Drug and Cosmetic Act violations, federal and state anti-kickback law violations, and other relevant fraud and abuse laws led by US local, state and federal civil and criminal government enforcers 

Corporate Compliance

• Advise on and implement compliance program infrastructures, such as committee structures and organizational considerations, auditing and risk assessment programs, charters, policies and procedures
• Conduct internal compliance effectiveness reviews, compliance audits and internal investigations
• Advise and train boards of directors, senior management and compliance personnel on corporate compliance obligations

FDA, EU and UK Compliance Obligations

• Provide strategic advice on product development and placement and governing regulations
• Counsel regarding all aspects of clinical trials, including interactions with authorities, principal investigators, sites, CROs and related service providers, in relation to post-market Phase IV clinical studies, data privacy issues and clinical study reporting obligations
• Prepare and advise on development plans and key meetings with FDA, EMA, European Commission and national authorities in EU Member States and the UK
• Counsel drug, biologic and medical device clients in pre-approval and post-commercial strategies and compliance matters
• Advise on all aspects of advertising of drugs and medical devices, marketing and promotional compliance, including labeling and advertising claims review, social media and interactions with HCPs
• Counsel regarding nonpromotional and scientific activities related to interactions with HCPs and related responses to unsolicited requests for information, medical information to HCPs and disease state awareness activities
• Advise on Risk Evaluation and Mitigation Strategies, including the US Prescription Drug Marketing Act sampling compliance and equivalent provisions in the EU and the UK, adverse events, recalls and medication guides
• Assist clients in development of digital health offerings and mobile health and interactions between digital components, drugs, medical devices and data privacy obligations
• Participate regularly or ad hoc on promotions review committee to suggest modifications and assess legal risk of proposed advertising and promotions
• Represent individuals and entities in civil and criminal enforcement actions brought by the government for violations of the US Federal Food, Drug, and Cosmetic Act, Public Health Services Act and related statutes

Contractual Relationships

• Draft and negotiate a wide variety of agreements between manufacturers, healthcare and life science providers, HCPs, health institutions, suppliers and purchasers, such as clinical trials, goods and services agreements, co-development agreements and consulting agreements
• Draft template healthcare provider service agreements for anti-kickback safe harbor compliance
• Draft and negotiate agreements concerning rebates, discounts, managed care provider agreements, pharmacy benefit management services, co-promotions, vendor agreements, practice entity formation, purchase and lease agreements and administrative services agreements
• Draft and negotiate agreements concerning grant, sponsorship and charitable contributions  

Transparency/Sunshine Laws

• Advise on implementation, tracking and reporting obligations for US federal and state marketing and disclosure laws and equivalent laws in the EU and the UK
• Respond to government inquiries in the US, EU and UK, conduct internal investigations and advise on corrective and disciplinary action
• Counsel regarding audits of reported data, assist in development of compliance policies and procedures and conduct internal preparatory audits
• Provide comments to proposed regulations and other guidance concerning scope, changes and potential impact in the healthcare and life sciences sectors

Coding, Coverage & Reimbursement

• Provide guidance to manufacturers regarding how private, state and federal payors cover and/or pay for products in the US, EU and UK
• Assist companies with determining conditions of participation in government programs and in preparing related requests for participation
• Advise regarding Medicare (all parts), Medicaid (including fee-for-service and managed Medicaid), DOD, VA, CHAMPUS/TRICARE, Federal Employees Health Benefits Programs coverage, commercial payor coverage issues and state law benefit mandates
• Advice concerning pricing and reimbursement processes in EU Member States and UK and related obligations and restrictions
• Analyze and assist clients in implementation of patient assistance programs 

Healthcare Data Privacy

• Counsel clients on federal (e.g. HIPAA), state and international (e.g. GDPR) privacy laws, and assist with day-to-day privacy and security questions

• Draft policies, procedures and related documentation for compliance with GDPR, UK data privacy obligations and HIPAA and assist with compliance infrastructure implementation, including conducting training

• Provide counsel to clients regarding data breach reports and responses and related government disclosures and support clients in connection with data breach investigations

• Assist clients with responding to patient or member complaints related to GDPR, EU data privacy and HIPAA or HITECH compliance

• Advise clients with determining GDPR, UK, HIPAA and applicable US state law obligations during transactions involving the sharing of protected health information

Digital Health/Telehealth

• Counsel clients on transaction structures to address state corporate practice of medicine and related professional licensing standard and restrictions
• Assist clients with web platform terms of use, privacy policies, as well as consumer/customer online registration and consenting processes
• Monitor and advise clients on payor coverage and reimbursement policies for telehealth

Regulatory Due Diligence

• Advise purchasers, investors and financial groups in connection with transactions within the healthcare and life sciences industries
• Conduct regulatory due diligence reviews to identify and assess risks associated with target companies and their products and research activities in the healthcare and life sciences industries
• Draft comprehensive reports to identify and implement compliance enhancement opportunities
• Prepare EU, UK and US local, state and federal health regulatory transactional filings and notices and evaluate and structure arrangements to comply with all relevant laws, including fraud and abuse requirements
• Provide due diligence services for companies and investors involved in strategic transactions, financings and public offerings
• Provide regulatory and quality standards and compliance terms for vendor agreements

US Licensure & Accreditation

• Analyze and review proposed transactions for state licensure and/or accreditation impact
• Advise clients regarding certificate of need, initial licensure and change of ownership licensure approval process and notification requirements
• Prepare licensure and certification related regulatory filings
• Assist client in preparation for licensure and accreditation surveys and audits 
• Coordinate client communications and deficiency notice responses to licensing and accreditation agencies

Health Reform Counseling & Strategic Planning

• Assist clients in the design, implementation and monitoring of programs created in response to health reform and programs to expand healthcare access
• Counsel clients and develop strategies for the impacts, risks and opportunities of legislative proposals and Congressional actions, including investigations
• Monitor legislative and regulatory developments and assist clients in responding to proposed changes, including advocacy for modifications, preparing comments to proposed regulations and developing strategies to address the changing landscape