Health Policy, Reimbursement, and Executive Branch Advocacy
Our Health Policy and Reimbursement Strategy Group advisors possess deep yet broad health policy experience, working across a wide array of healthcare technology companies. They regularly provide strategic advice and tactical support for cutting-edge healthcare companies of all sizes. Their work spans both traditional health policy and coverage, coding, and payment issues. Our advisors also regularly represent clients before the Administration and other health policy stakeholders.
Health Policy Strategic Advising As a Washington DC-based health policy firm, our advisors are at the forefront of emerging health policy developments and keep a strong pulse on shifts occurring in the healthcare landscape. With extensive experience in understanding how policy processes work in Washington and within the Administration, we are well-versed in assisting companies in navigating the complexities of health policy issues in federal healthcare programs and engaging on priority policy proposals for clients.
Our health policy strategic advising services are unique to each client and their technologies, as well as their long-term policy priorities. Our goal in strategic advising is to ensure that companies’ health policy strategic plans are attuned to the healthcare landscape, well-informed by existing regulations and guidance, and continually updated as developments in the landscape occur. These services typically are provided on an ongoing basis, with our team providing regular advice and support based on established priorities for the client.
Federal Healthcare Programs K&A’s policy advisors have spent their careers immersed in policy aspects of the federal healthcare programs, particularly Medicare, Medicaid, 340B and TRICARE. We have deep understanding of the Medicare payment systems, such as the Medicare Physician Fee Schedule, the Medicare Inpatient Prospective Payment System, the ESRD Prospective Payment System, the Hospital Outpatient Prospective Payment System, and the Medicare Part D Program; the Medicaid Drug Rebate Program; the 340B Drug Pricing Program; and the TRICARE prescription drug program. We also remain at the forefront of value-based payment demonstrations and other changes in federal payment systems, such as the Quality Payment Program.
We assess and advise on health policy proposals in rulemakings and guidance relating to these programs and the impacts on our clients. Our advisors guide clients seeking to advance policy proposals under these systems, as well as those seeking to meet with the federal government. We also regularly conduct research and develop work product, such as presentations, to respond to client questions on these programs.
Coverage, Coding, and Payment Our advisors provide support to clients on an array of coverage, coding, and payment strategy issues for healthcare technology companies: Coverage, Coding, & Payment Education We regularly conduct educational presentations on the foundations of coverage, coding, and payment for healthcare technologies to assist companies in building tactical plans. Our advisors are knowledgeable about the coverage standards that apply for healthcare technologies in federal healthcare programs and conduct assessments to identify threats and opportunities for pre-commercial technologies. We are experienced in working with the Centers for Medicare and Medicaid Services (CMS) on National Coverage Determination (NCD) policies, including representing clients through the National Coverage Analysis (NCA) process. Our advisors also assist clients in remaining abreast of changes occurring through the Local Coverage Determination (LCD) process with the Medicare Administrative Contractors (MACs).
Coding Our advisors support clients on a variety of coding applications and related services, such as:
Coding Education: We provide education to clients regarding the various coding systems that apply to healthcare technologies and the importance of different codes to a successful reimbursement strategy.
HCPCS Coding Services: Our advisors possess extensive experience representing companies seeking HCPCS codes. We provide end-to-end support for developing and submitting HCPCS applications, as well as preparing companies to present at HCPCS public meetings. We recommend that clients begin HCPCS applications well in advance of submission deadlines based on the strategic considerations and research that must be completed for a successful coding application.
ICD-10-CM Diagnosis Coding Services: Our Group provides full-scale support for organizations engaging in the ICD-10-CM Diagnosis Coding revision process. These services include development and submission of the coding application, preparation for and representation at the public meetings, and development and submission of comments in support of the application.
Transitional Pass-through Payment Services: Our team assists clients in preparing and submitting Transitional Pass-through Payment Applications for biopharmaceuticals under the Medicare Hospital Outpatient Prospective Payment System. These services include full-scale application development and submission, as well as education relating to the pass-through payment process and longer-term strategic considerations relating to the initial launch phase of a biopharmaceutical.
Payment Our advisors are well-versed in payment methodologies that apply to healthcare technologies across federal healthcare programs. We assist companies in understanding the cascade of payment methodologies that apply for newly commercialized technologies in federal healthcare programs. Our Group regularly assists clients in navigating Medicare’s complex payment systems, such as the Hospital Outpatient Prospective Payment System and the Medicare Physician Fee Schedule.
Biopharma Advising Our advisors possess extensive experience working on health policy and reimbursement strategy issues for biopharmaceutical companies. Our advisors have worked in-house, at trade associations, and represented an array of biopharmaceutical companies. We have worked on the implementation of nearly every major biopharmaceutical law that Congress has enacted and CMS has implemented via regulation over the past twenty years, from the institution of the Medicare Part B Average Sales Price System (ASP) to the start of the Medicare Part D program. Our Group regularly advises biopharmaceutical companies of all sizes, from pre-commercial companies to some of the largest biopharmaceutical companies in the world, with our services varying based on company structure and areas of need.
Health Policy Our Group provides strategic advice and consulting support on health policy issues for biopharmaceutical companies. We are at the forefront of changes occurring across the health policy landscape, from policy proposals emerging in federal rulemakings to guidance developments occurring at agencies. Through these services, we ensure our clients are informed of critical changes of potential impact to their companies, as well as actions to take in response to these developments. We also assist companies in building proprietary strategic plans for proactive policy proposals they are seeking to advance. Examples of health policy services that are most frequently requested by clients include:
Assessments of proposed and final rules in the Federal Register for identification of health policy impacts
Development of comments for submission in response to proposed rules
Assistance in engaging with the federal government on health policy matters
Research and work product development on health policy projects
Monitoring of MedPAC, MACPAC, and other policy bodies
Development of talking points and one-pagers on policy issues
Gene & Cell Therapy Our firm possess experience in representing cell and gene therapy companies on an array of health policy and coding, coverage, and payment matters. Our advisors are knowledgeable on the critical policy issues and developments for these therapies, such as genetic screening considerations, innovative payment priorities, existing system barriers, and care coordination complexities. We assist these companies in taking an agile approach to the shifting health policy landscape while advocating for policies and structural changes to better reflect the unique nature of these therapies.
Support for Pre-Commercial Companies Our firm often works with pre-commercial companies several years in advance of their first launch, assisting companies in developing and executing on a strategic health policy plan. These services often involve the following:
Assessment of coverage, coding, and payment health policy issues to identify opportunities and potential barriers
Education on federal healthcare programs for biopharmaceuticals, such as Medicare, Medicaid, and 340B
Development and education of a health policy strategic plan
Research support to respond to ongoing questions in preparing for launch
Health Policy Presentations and Meeting Facilitation Our advisors present on health policy matters at conferences, Board meetings, and client cross-functional team meetings. We also have experience facilitating cross-functional meetings to attain alignment on policy priorities and objectives, as well as serving as moderators at health policy-focused events.