Bob handles corporate transactions and provides regulatory counseling relating to health care services, pharmaceuticals and medical devices. He also assists in health care-related litigation, investigations and disputes, and in legislative and regulatory policy issues and related advocacy and drafting.
A core element of Bob’s practice is negotiation of agreements relating to pricing and/or provision of prescription drugs and other health care 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 (a/k/a value-based rebates), rebates on drugs covered under a medical benefit, and Medicaid supplemental rebates;
- PBM service agreements with MCOs, including provisions relating to pharmacy network pricing and composition, manufacturer rebates and compliance with regulatory requirements;
- Payer agreements between PBMs or MCOs and pharmacies or other types of health care providers;
- Specialty pharmacy agreements with pharmaceutical manufacturers;
- Contracted pharmacy agreements under the federal 340B program;
- Group purchasing organization (GPO) agreements;
- Pharmaceutical distribution agreements;
- Direct sales, rebate and chargeback agreements between drug 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 clients involved in life sciences and health care, including acquisitions, divestitures, joint ventures, financings and service agreements. For example, he has handled corporate and/or health care regulatory aspects of mergers and acquisitions of numerous types of health care companies and assets, including:
- Pharmacies;
- Prescription drugs;
- Hospitals, nursing homes and assisted living facilities;
- Various types of service providers; and
- Data services.
Bob’s regulatory counseling encompasses the full range of issues relating to the provision of and payment for health care services, 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, Medicaid and commercial health plans, particularly those relating to Medicare Part D, Medicare Advantage and Medicaid managed care plans and to requirements under the Affordable Care Act;
- Federal and state laws (existing and proposed) regulating PBMs or drug pricing;
- 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.
