Health Industry Compliance & Government Enforcement
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Areas of Experience
Health Industry Compliance and Government Enforcement is an area where a law firm’s experience, credibility, and judgment predominately influence a company’s choice of legal representation. The attorneys in Morgan Lewis’s FDA and Healthcare Practice are nationally recognized as leaders in health industry compliance and enforcement matters and provide compliance guidance, fraud and abuse counseling, and corporate defense in government investigations and proceedings to manufacturers, suppliers, vendors, GPOs, hospitals and health systems, academic medical centers, pharmacies, specialty and long-term care providers, health plans, clinical research organizations, medical societies, private equity companies, and physician practices. Our team exclusively represents the health industry in compliance and enforcement matters and brings unique government and industry perspectives to assist our clients in a wide variety of health industry compliance and enforcement matters.
Our multisector health industry focus enables us to provide integrated and collaborative legal guidance and manage a company’s credibility dividend with the government, patients, investors, business partners, and the public. Our compliance and enforcement representations are substantially assisted by our healthcare industry experience in FDA, clinical research, federal reimbursement, federal and state regulatory issues, DEA and pharmacy, EU transactions, and privacy and security matters.
With international clients of all sizes, and Morgan Lewis offices in London, Paris, Brussels, Frankfurt, Beijing, and Tokyo, our health industry compliance and enforcement representations increasingly have a global focus and involve counseling, internal reviews, and corporate defense related to sales and marketing, clinical research, and other business activities for small and large clients with international operations.
On healthcare compliance issues our team represents companies in both voluntary internal compliance efforts and in government-mandated compliance, including compliance reviews and assessments, policy development, internal investigations, state and federal consent decrees, HHS-OIG Corporate Integrity Agreements, and DOJ deferred-prosecution agreements (DPAs). We provide integrated regulatory, reimbursement, anti-kickback, Stark Law, FCPA, and industry codes of ethics counseling as part of compliance reviews, internal investigations, business transactions, and corporate due diligence reviews. Our team often serves as special counsel in internal and external compliance matters to assist the effective navigation of complex legal and business issues that may substantially impact corporate operations and reputation.
Fraud and Abuse Counseling
Domestic and international anti-kickback laws, conflict of interest regulations, and evolving industry codes of ethics dominate the management of business transactions, practices, and arrangements. Our attorneys provide integrated fraud and abuse and health industry ethics counseling to a wide variety of health industry arrangements and collaborations. We are conversant with emerging trends in transactions and arrangements, including bundling, discounts, pricing, quality and clinical incentives, OIG Advisory Opinions, state marketing laws, and relevant industry codes of ethics. Because we also handle government enforcement issues nationally and in multiple federal and state jurisdictions, we have a real-time sense of emergent fraud and abuse issues that can impact business practices, transactions, and relationships.
Healthcare Fraud Enforcement and Program Integrity
Our team represents healthcare organizations in state and federal investigations and criminal, civil, and administrative legal proceedings. Members of our team are nationally recognized False Claims Act practitioners and thought leaders and have handled federal and state investigations in more than 36 jurisdictions. Our attorneys have led government healthcare fraud investigations and False Claims Act matters as healthcare fraud prosecutors and now health industry defense counsel in hundreds of matters since the early 1990s. Our matters involve government and qui tam whistleblower allegations of off-label promotion, kickback and Stark Law violations, reimbursement irregularities, and quality of care and privacy violations. Many of our matters are parallel proceedings that involve multiple government prosecuting agencies and multiple defendants at the federal and state levels. We have represented clients in matters concerning OIG exclusion, and in other agency debarment matters arising from healthcare enforcement prosecutions as well as Medicare billing revocation matters and ZPIC and RAC reviews. Our team often consults as special counsel in existing matters for other law firms and healthcare companies.
OIG Corporate Integrity Agreements and Government Consent Decrees
Government-mandated compliance measures are part of many government resolutions and impose significant obligations on a healthcare company. We strategize at the inception of a matter with our clients to avoid formal government compliance mandates in appropriate circumstances and to negotiate and implement realistic provisions in settlements that require mandated compliance terms. Our team has been involved—as DOJ healthcare fraud prosecutors, OIG counsel, defense counsel, and special counsel—in countless negotiations since the early 1990s related to government mandated compliance agreements in the health industry involving quality of care, privacy, fraud and abuse, sales and marketing, FDA promotion, billing, DEA, and pharmacy matters.
Health Industry Compliance Training and Policy Development
Many compliance and enforcement matters compel compliance training and policy development unique to a particular company or industry sector. Our health industry attorneys have conducted voluntary and government-mandated compliance training for the boards of directors, senior management, risk management, quality assurance, and sales and marketing divisions of hospitals, long-term care providers, device companies, pharmaceutical companies, and other healthcare companies. We have developed new compliance policies related to product purchases and development, industry collaborations, clinical research, conflict of interest, off-label use, charitable contributions, grants, education funding, gifts, entertainment, CME funding, and transparency and disclosure programs.
Transparency and Disclosure Compliance
Our team is deeply involved in state and federal transparency and disclosure compliance, including the Massachusetts Marketing Law and related requirements in other state jurisdictions, including California. We have assisted device companies, pharmaceutical companies, hospitals, physicians, and medical societies in complying with emerging legal and codes of ethics requirements and in developing effective transparency and disclosure policies.
DEA and Pharmacy Compliance
Members of our team have worked in government and in the private sector on DEA institutional compliance and enforcement issues for hospitals, nursing homes, hospice, and institutional pharmacies. We have also worked with various state boards of pharmacy on regulatory issues, including the California Board of Pharmacy. Our team has defended diversion investigations, assisted the reporting of regulatory violations (including diversion issues), undertaken compliance assessments, and developed related policies and protocols.
Corporate Transaction Due Diligence
Our team assists companies engaging in corporate transactions, acquisitions, and mergers in assessing compliance and enforcement issues, including anti-kickback and Stark physician self-referral compliance, False Claims Act investigations and litigation, and compliance with healthcare regulations.
Government Disclosures for Regulatory Violations
Many aspects of our healthcare compliance practice involve an assessment of government disclosure issues and strategies. Our team has assisted clients with practical assessments of disclosure issues and with the necessary government communications that must occur in any disclosure process.
Health Industry Leadership
The attorneys in Morgan Lewis’s FDA and Health Practice are nationally recognized in the health industry as thought leaders and counselors on healthcare compliance and government enforcement issues. In addition to our government, industry, association, and private sector experience in all aspects of the health industry, our team has authored articles, treatises, and book chapters on fraud and abuse issues and serve in leadership positions in the American Health Lawyers Association and the American Bar Association. We are frequently invited to speak at health industry and professional conferences on healthcare compliance and enforcement issues; are active members of AdvaMed and FDLI; and serve as faculty for the Seton Hall Compliance Certification Program and the Healthcare Compliance Association. Our team publishes a bimonthly column on pharmaceutical issues for the Journal of Healthcare Compliance and are invited faculty at FDA-sponsored education programs.