Reed Smith offers medical device, diagnostic, pharmaceutical, biologic and biotechnology firms a wide array of reimbursement analysis and advocacy. Today’s health care environment places new pressures on the introduction of innovative medical products. Reed Smith’s Life Sciences Practice provides comprehensive reimbursement support to help companies anticipate and respond to these pressures when developing advanced therapeutic, rehabilitative, diagnostic and monitoring technologies.
Reed Smith’s health care/life science attorneys and policy analysts work with life sciences companies in the following areas:
- CPT procedure codes
- HCPCS drug, device and durable medical equipment codes
- ICD-9-CM diagnosis and procedure codes
- National Medicare coverage policies
- Local medical review policies – Medicare carriers and fiscal intermediaries
- Blue Cross and Blue Shield Technology Evaluation Center (TEC) policies
- Private insurer and managed care coverage policies
- Inpatient hospital Diagnosis Related Group (DRG) and new technology DRG add-on
- Outpatient hospital Ambulatory Payment Classification (APC) and pass-through payment
- Medicare physician and diagnostic test payment under the resource-based, relative value schedule (RBRVS)
- Clinical laboratory test payment under gap-filling, cross-walking and Medicare national limitation amounts
- Durable Medical Equipment, prosthetics, orthotics and supplies (DMEPOS) payment under DMERC fee schedules
- Drug payment under AWP and related authorities
Reed Smith’s Life Science lawyers provide medical technology manufacturers with the following services:
- Reimbursement feasibility analysis
- Reimbursement strategic planning
- Coverage, coding and payment documents
- Reimbursement guidelines for hospital and physician customers
- Coordination with medical specialty societies
- Advocacy before local and national Medicare agencies
- Support from federal and state legislative bodies
Our attorneys have worked on federal reimbursement and drug pricing matters since the initiation of these programs, and are well-versed when it comes to reimbursement and pricing reporting issues. They regularly provide guidance to manufacturers with respect to pharmaceutical pricing issues associated with managed care, federal program reimbursement, the Medicaid Best Price Program and Section 340B of the Public Health Service Act, the Veterans Health Care Act, and the Medicare Average Sales Price requirements. We assist clients in understanding and analyzing the impact of the Medicare Modernization Act (“MMA”) and Deficit Reduction Act on their operations. We also have facilitated client interactions with CMS on a variety of MMA-related issues, including the Medicare Prescription Drug Card Program, Part B and HOPPS payment changes, the Section 641 demonstration project, and the Part D outpatient drug benefit.
Reed Smith brings a highly qualified team of attorneys, several of whom have practiced in government agencies, including in the U.S. Department of Health and Human Services; medical professionals including nurses and a physician; and health policy analysts with experience in all facets of legislative and regulatory policy-making.
Getting new drugs, biotechnology products, and medical devices recognized by payors requires careful advance planning. Reed Smith supports established corporations and start-up firms with comprehensive integrated reimbursement advocacy.