Health Care Services – Regulatory
OVERVIEW
The regulatory environment around Medicare, Medicaid, and other Federal health care programs is highly complex and constantly evolving. LPG’s team has decades of experience allowing us to assist manufacturers, providers and plans in addressing emerging policy issues and challenges that impact both reimbursement and operations. Stakeholders must navigate a complex set of Medicare and Medicaid regulations, guidance, and procedures to ensure appropriate reimbursement for the products and services they provide. LPG’s expertise in policy, government process matters, and in engaging key Federal policy makers ensures that our clients have the best possible opportunity to be successful in meeting their goals.
LPG has policy expertise in every major area of Medicare and is able to assist hospitals, post-acute care facilities, Medicare Advantage (MA) plans, and other providers and organizations in understanding and determining the impact of the myriad of policy changes and issuances by CMS related to payment, quality, oversight, innovation models, and other programs that may impact reimbursement, operations, and how they interact with Medicare. For example, LPG reviews annual payment regulations; sub-regulatory issuances, and contractor guidance impacting reimbursement levels and coverage. Where challenges arise or a particular policy outcome is desired, LPG works closely with its clients to craft a policy response and design a specific advocacy approach to ensure the best possible result.
For manufacturers of new health care technologies and drugs, LPG formulates reimbursement strategies based on key questions such as: Are there legal or policy obstacles to Medicare coverage? Do local or national coverage determinations apply? How should the product or service be coded? Is payment made on an individual basis or bundled into a larger service or episode-based unit within a payment system? Are there additional payment avenues available for new technologies at launch? Should we engage with CMS or Medicare Administrative Contractors (MACs) and when? In addition, LPG closely tracks and assists clients in understanding and responding to the potential for broader changes in Federal health care programs. For example, where is drug pricing reform headed? How will future Medicare Part B and/or Part D payment reforms impact a client’s product? LPG then guides manufacturers through the application process and engages key decision makers at CMS.
REGULATORY TEAM
Our team’s experience uniquely positions us to respond to these questions and develop and execute clear and comprehensive reimbursement strategies. Tom Scully served as CMS Administrator in the George W. Bush Administration. In this capacity, Tom functioned as the Administration’s top negotiator for the development and passage of the Medicare Part D benefit and made foundational reforms to MA. Rudy Missmar is a former Partner at a prominent Washington, D.C. law firm, and analyst at Avalere Health, who has provided clients with technical reimbursement and policy expertise – including developing reimbursement strategies and drafting and submitting coverage, coding and payment applications – while interacting with political and career CMS staff for 15 years.
In 2019, Laurence Wilson and Colin Roskey joined LPG’s health care team. Laurence spent more than 30 years working at CMS, where he was a Senior Executive and the Director of the Chronic Care Policy Group. At CMS, Laurence was responsible for payment and benefits policy on a broad range of Medicare health care benefits and payment systems, including post-acute care, hospice, dialysis, durable medical equipment, and various hospital services. Colin returned to LPG after working on policy and legislative issues as a Deputy Assistant Secretary within the Office of the Secretary of the U.S. Department of Health & Human Services. With their recent Federal government experience, Colin and Laurence are uniquely positioned to offer clients policy insight on key health care programs.
AREAS OF EXPERTISE
LPG has a wide range of expertise related to coverage, coding, and payment for all sites of care and types of products and services. The following provides examples of our past and current work:
Developed policy positions and drafted comment letters on all major CMS proposed rules, including Medicare Inpatient Prospective Payment System (IPPS), Outpatient Prospective Payment System (OPPS), End Stage Renal Disease (ESRD)-PPS, Physician Fee Schedule (PFS), Inpatient Rehabilitation Facility (IRF)-PPS, Skilled Nursing Facility (SNF)-PPS, and Home Health PPS;
Advised and represented clients before CMS and HHS on a wide range of Medicare regulatory and program issues such as Part B and Part D drug pricing, modernization of Medicare Advantage and the Part D drug benefit, hospital price transparency, 340B payments, various innovation models, post-acute provider payments, dialysis payment reform, and durable medical equipment competitive bidding;
Assisted manufacturers in successfully obtaining separate reimbursement from Medicare through various payment mechanisms, including “pass-through” status and New Technology Ambulatory Payment Classification (APC) assignments under OPPS; and New Technology Add-On Payment (NTAP) status and Medicare Severity Diagnosis Related Group (MS-DRG) reclassifications under IPPS;
Assisted manufacturers in obtaining coverage and coding for new drugs, biosimilars, devices, as well as cell and gene therapies (e.g., Chimeric Antigen Receptor T-cell (CAR-T) therapy), including representing clients to CMS and MACs, and drafting successful coding applications for Healthcare Common Procedure Coding System (HCPCS), Current Procedural Terminology (CPT), and International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10) codes, and presenting at CMS public meetings; and
Worked with clients to propose to the Center for Medicare & Medicaid Innovation (CMMI) new payment models including outcomes-based models, as an alternative to traditional Medicare outpatient and inpatient reimbursement.
