Bob handles corporate transactions and provides regulatory counseling relating to health care, pharmaceuticals and medical devices. He also assists in health care-related litigation, investigations and disputes. A member of Reed Smith’s Life Sciences Health Industry Group with more than 25 years’ experience in health care matters, Bob combines a deep understanding of the legal requirements and industry practices shaping the health care industry with extensive transactional skills and experience. Bob draws upon his and his colleagues’ knowledge of constantly-evolving industry and legal developments, such as health care reform initiatives and novel legal theories in false claims act or class action litigation, to help clients navigate through the thicket of risks and achieve success in today’s challenging legal and industry environment.
A core element of Bob’s practice is negotiation of agreements relating to medical device and prescription drug pricing and related services. These include:
- Rebate agreements between pharmaceutical manufacturers and pharmacy benefit managers (“PBMs”), managed care organizations ("MCOs”) or other payers, including agreements relating to formulary rebates, market share rebates, outcomes-based rebates, rebates on drugs covered under a medical benefit, and Medicaid supplemental rebates;
- PBM service and drug pricing agreements with MCOs and other payers;
- Specialty pharmacy agreements with pharmaceutical manufacturers;
- Pharmacy, hospital and other provider agreements with payers;
- Contracted pharmacy agreements under the federal 340B program;
- Group purchasing organization (“GPO”) agreements;
- Distribution agreements;
- Direct sales, rebate and chargeback agreements between manufacturers and hospitals, pharmacies and other health care providers; and
- Various innovative arrangements, including sale of products on a consignment basis and long-term pricing agreements in connection with joint ventures.
Bob also handles or advises upon a wide variety of corporate transactions for life sciences and health care clients including acquisitions, divestitures, joint ventures, financings and service agreements. For example, he represented a health system client in entering into a service contract and subsequently forming a joint venture relative to “hospital at home” services. He has handled both corporate and regulatory aspects of mergers and acquisitions of numerous types of health care companies and assets, including hospitals, pharmacies, nursing homes, assisted service providers and prescription drug marketing rights.
Bob’s regulatory counseling encompasses the full range of issues relating to the provision of and
payment for health care, medical devices and pharmaceuticals. These include:
- Federal and state fraud & abuse laws, including the federal anti-kickback statute, safe harbor regulations, civil monetary penalties, and federal and state false claims acts;
- Rules and guidance applicable to Medicare Parts A and B, Medicare Advantage, Medicare Part D, Medicaid (including Medicaid managed care organizations), and ACA Exchange qualified health plans;
- Review of agreements and transactions for compliance under clients’ Corporate Integrity Agreements (CIAs) with the Office of Inspector General (OIG) of the Department of Health and Human Services; and
- HIPAA, electronic medical records, e-prescribing, the federal 340B program, government price reporting for pharmaceuticals, patient assistance program issues, excluded provider issues, FDA issues, products liability issues, and Robinson-Patman and antitrust issues.
Bob’s litigation-related work includes assistance with respect to:
- Governmental investigations, litigation and settlements under the federal anti-kickback statute, state and federal false claims acts and other state and federal fraud & abuse laws, including assistance in responding to subpoenas and civil investigative demands, drafting and review of pleadings, and assistance with negotiation of settlement agreements and CIAs;
- Disputes between private companies alleging breach of contract or other legal theories, including default notices, mediation, arbitration, litigation and settlements; and
- Health care-related class action litigation.
