Overview
The United States health care industry continues to face challenges arising from transforming business models, evolving government roles and guidelines, and increased government scrutiny of business practices. Burke, Warren, MacKay & Serritella has the experience necessary to help clients achieve their business goals in a manner that successfully navigates this evolving business and regulatory landscape. Our practice is national in scope and our clients range from start-up ventures to Fortune 20 corporations.
We are able to provide prompt, effective, and efficient legal guidance by leveraging our intimate knowledge of our clients’ businesses and our sharp focus on relevant legal issues. We have represented clients throughout the health care industry, both for-profit and non-profit, including pharmaceutical manufacturers, bio-tech companies, pharmacy benefit management companies, specialty pharmacies, retail clinics, home health agencies, DME vendors, retail pharmacies, physician practices, hospitals, academic medical centers, and health insurers.
Services Provided
Regulatory Compliance and Risk Mitigation
Our attorneys have significant expertise in regulatory and compliance matters, including fraud and abuse compliance, state and federal anti-kickback and anti-referral laws, conflict of interest disclosure and management processes, corporate practice and fee splitting, and privilege and confidentiality issues. We work closely with our clients to provide effective guidance necessary to successfully address the business and legal challenges of these complex laws. Our areas of focus include:
- Guidance on appropriate structure of transactions and contractual arrangements to minimize fraud and abuse risk
- Guidance on payment structures, including GPO and PBM administrative fees, client credits, rebate and discount payments, and service fee arrangements
- Guidance on implications of various sales and marketing practices, including customer incentive and retention programs and physician office interactions
- Development of corporate compliance programs, policies, and codes of conduct
- Guidance on HIPAA and HITECH compliance
- Guidance on privilege and confidentiality issues uniquely applicable to mental health records and communications
- Compliance training for in-house legal departments and their business counterparts
- Internal compliance audits and guidance on the best manner to address audit findings
- Appropriate and effective handling of cases alleging staff negligence or misconduct
Operational Contracting
Our expertise and efficiency enable us to become trusted advisors to clients in the operational contracting that is necessary to allow their businesses to thrive. Clients have relied on us not only to develop and refine their contracting documents and models, but also to assume ongoing responsibility for day-to-day negotiation of their business contracts. Our attorneys also serve as outside general counsel for a number of companies. Our areas of focus include:
- Pharmaceutical product purchase, sale, and distribution agreements
- Pharmaceutical product service agreements, including data supply, pharmacy adherence, and adverse event reporting
- PBM rebate agreements
- GPO network contracting
- Clinical affiliation agreements
- Payor and provider contracting
- Practice management agreements
- Physician employment and independent contractor agreements
- Vendor service agreements
- Business associate agreements
Corporate Transactions
Clients appreciate the effective and efficient manner in which we successfully negotiate and complete corporate transactions. We seamlessly incorporate a multidisciplinary approach with other Burke Warren practice areas, including Corporate, Tax Advisory Services, Employee Benefits, Labor and Employment, and Real Estate. Further, our deep industry knowledge and legal expertise enables us to provide exceptional regulatory due diligence and identify risks that not only materially affect the valuation of the deal, but would also create significant post-closing liability. Our areas of focus include:
- Mergers, acquisitions, divestitures, and reorganizations
- Specialized regulatory due diligence examinations of target company compliance, including business practices and contracting models
- Partnerships, joint ventures, and other collaborations
- Debt and equity financings, including traditional bank lending, debt restructurings, venture capital financings, and securities offerings
- Tax structuring analysis and guidance
Employment and Labor
Our depth of knowledge of and experience in the health care market affords clients unique assistance in efficiently and effectively addressing employment and labor issues on behalf of management. Our areas of focus include:
- Union organizing attempts
- Union contract negotiation and resolution
- Grievance arbitrations
- Administrative agency disputes (EEOC, NLRB, et al)
- Wrongful termination disputes
- Employee disciplinary disputes
- Employment-related policies and procedures and related statutory/administrative compliance
Clients
We represent clients throughout the health care industry, both for-profit and non-profit, including:
- Academic medical centers
- Ancillary services providers
- Biotechnology companies
- Disease management companies
- DME vendors
- Health plans and other health insurers
- Home health providers
- Hospitals and health systems
- Nursing homes, skilled nursing facilities, and assisted living facilities
- Pharmaceutical manufacturers
- Prescription benefit management companies
- Physician practices
- Physician management companies
- Retail clinic providers
- Retail pharmacies
- Social service agencies
- Specialty pharmacies
