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 (including rebates on Part B drugs covered under Medicare Advantage plans), and Medicaid supplemental rebates;
- Agreements between MCOs and PBMs relating to PBM services and drug pricing;
- Payer agreements between PBMs or MCOs and various types of health care providers, including hospitals, long-term care facilities and pharmacies (for retail, specialty, long-term care and mail order pharmacies);
- 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 life sciences and health care clients, 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;
- Nursing homes and assisted living facilities;
- Varios types of service providers;
- Data services; 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 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 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.
