Mark Gooding provides strategic guidance to life sciences clients on policy developments and reimbursement considerations.
In particular, Mark has extensive experience analyzing federal- and state-level policies and developing market access strategies to drive coverage and patient access. His work at Avalere has focused on a broad range of topics and therapeutic areas, including drug pricing, payer coverage, patient support programs, and payment considerations for CKD and ESRD therapies.
Prior to joining Avalere, Mark was a senior associate at Covance Market Access Services, supporting pharmaceutical manufacturers by conducting market research with payers and providers on issues, including coverage decision-making, reimbursement and financial support program optimization, and alternative payment model implementation. Prior, Mark worked at George Washington University’s Department of Health Policy, where he focused on issues including the development and implementation of the Affordable Care Act, state Medicaid policy, and early childhood development.
Mark earned an MPS in political management from the George Washington University and a BA in political science and philosophy from Wake Forest University.
Authored Content
The TDAPA supports payment and patient access to new therapies introduced to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS). While no major TDAPA revisions were finalized in the Calendar Year (CY) 2021 ESRD PPS Final Rule, stakeholders should continue to monitor this payment adjustment policy, as it has evolved since its introduction and may continue to change in future rulemaking cycles.
Implementation of copay accumulator and maximizer programs continues to increase; recent policy provisions finalized through federal rulemaking and state-level legislation have created new uncertainty for the future of these programs and the stakeholders they affect.
The COVID-19 public health emergency, new policy changes, and existing unmet patient needs will pressure the evolving payer, provider, and reimbursement landscape for kidney care in 2021.
With a number of cell and gene therapies (CGTs) expected to obtain Food & Drug Administration (FDA) approval in the next 3 years, stakeholders must consider the unique patient access and affordability barriers that may limit patient ability to receive these novel treatments. Stakeholders should explore affordability solutions that can optimize access, or they risk excluding patients from obtaining potentially life-saving treatments.
The ESRD Treatment Choice model demonstrates an increased focus on improving health outcomes for Medicare patients receiving dialysis by realigning incentives to favor the adoption of home dialysis and increasing the rate at which patients receive kidney transplants. This mandatory model could lead to significant disruption for stakeholders in the coming years. Understanding the risk and opportunities associated with this model will be critical for patients, providers, and manufacturers alike.
On August 25, “Calcimimetic Use in Dialysis-Dependent Medicare Fee-for-Service Beneficiaries and Implications for Bundled Payment” was published in Kidney 360. The article featured research and analytics conducted by Avalere experts.
Recent CMS rulemaking has expanded the opportunity for new drugs and devices to achieve NTAP status, either through the traditional process or via alternative. Manufacturers that are nearing the launch of new technologies, especially in the antimicrobial space, should assess whether their technology may qualify for NTAP. Applications for NTAPs effective in FY 2022 are due this fall.
Mental Health Awareness Month and the COVID-19 crisis intersect—and highlight challenges in the US mental health care system
Although COVID-19 is introducing new challenges within the global pharmaceutical supply chain, the current situation also creates opportunities for stakeholders to evaluate drug security and implement risk-mitigation strategies around shortages and required stockpiles.
The kidney care payment and delivery landscape was poised for change in 2020 due to existing policies and market trends. Given the specific risk COVID-19 poses to these patients, the pandemic is creating new challenges and potentially accelerating existing trends in the kidney care space.
As the economic and social impact of COVID-19 change how patients access and receive care, manufacturers and third-party suppliers must consider how to evolve their patient support programs to meet the shifting access and affordability needs of patients.
The Centers for Medicare & Medicaid Services (CMS) issued a new Interim Final Rule (IFR) that is intended to allow additional beneficiaries, especially those who are at high-risk, to receive home infusions amid COVID-19 transmission concerns. Specifically, the CMS clarified the definition of “homebound” under the Medicare Home Health Benefit and temporarily suspended enforcement of the National and Local Coverage Determinations (NCD and LCD) related to home infusion services. Uncertainties remain as to how these new flexibilities will be utilized, as well as how these flexibilities could impact treatment outcomes.
The Center for Medicare & Medicaid Services (CMS) recently issued its proposed Notice of Benefit and Payment Parameters (NBPP) for the 2021 plan year. The proposed rule would significantly expand commercial payer flexibility to not count manufacturer copay support toward deductibles or out-of-pocket (OOP) maximums.
With new cell and gene therapies poised to revolutionize treatment for a growing number of disease states, stakeholders are working to reimagine existing value and reimbursement models to meet the special challenges these breakthrough services present.
A shifting policy landscape and emerging market forces could introduce significant disruption in the kidney care space in the coming years. Understanding the risks and opportunities that these changes may present will be critical for patients, providers, payers, and manufacturers alike.
Tune in to hear the final episode in our 3-part series that focuses on CMS’s most recent proposed payment rules. In episode 3, we’ll be focusing on the End Stage Renal Disease (ESRD) Prospective Payment System, with a focus on proposed payment changes for innovative drugs, supplies, and equipment and updates to the Quality Incentive Program (QIP).
Manufacturers currently face an almost-unprecedented level of uncertainty in developing contracting strategies for the coming plan years. Avalere’s combination of policy and commercialization expertise, paired with its data capabilities, allow us to support life sciences companies understand this challenging landscape to ensure access to innovative therapies for their patients.
Additional Medicare payment options available for new, high-cost technologies used in the inpatient setting.
Recent developments in the specialty pharmaceutical marketplace merit distinct attention from manufacturers.
The interaction of recently announced drug pricing reforms will have differential implications for stakeholders.