Meet
Mark Gooding
Practice Director
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
State legislators are attempting to reduce patient costs through Prescription Drug Affordability Review Boards.
State legislators are attempting to reduce patient costs and increase access through policies that block copay accumulators and maximizers.
The growth of DTC drug purchasing programs may shift the patient access and affordability landscape, with implications for manufacturers, payers, and other stakeholders.
The kidney care policy landscape is undergoing important changes, given shifts in the Trump administration’s priorities and a reassessment of existing kidney care models.
A DTC purchasing program could take various forms to enable patients to access MFN pricing.
A new EO revives international reference pricing as a core Trump administration priority, with a focus on Most-Favored Nation pricing through direct-to-consumer models, regulatory action, and broader enforcement measures.
Avalere Health’s analysis of early MPPP enrollment shows that only a small portion of beneficiaries who are likely to benefit from the program have enrolled.
Additional Medicare payment in the inpatient setting may be available to certain qualifying new technologies, but requires successful navigation of application processes.
Political changes, transplant system reforms, research advancements, and expanded CKD indications create opportunities and challenges in the kidney care space.
Avalere’s new CY 2025–2026 Coding and Regulatory Calendar supports life sciences firms’ strategic planning for critical coding deadlines, timelines, and regulatory updates.
Two Avalere experts captured information presented at a recent conference and published their perspectives in Pharmaceutical Commerce.
The MPPP introduces new considerations for Part D plans’ financial risk, operations, and enrollee engagement.
The MPPP will help improve Part D patient affordability, prompting manufacturers to reassess existing patient assistance programs and educational efforts.
The MPPP is a new payment option for Part D beneficiaries in 2025; patient groups will play a key role in supporting education and outreach on the program.
The Medicare Prescription Payment Plan will change how Medicare beneficiaries manage their Part D out-of-pocket costs, with implications across stakeholders.
At the 2024 BIO International Convention, Avalere led discussions on post-IRA patient access and affordability and reimbursement pathways for digital therapeutics.
Ahead of Asembia 2024, Avalere market access experts discuss the potential impacts of IRA provisions, including Part D redesign and Medicare drug price negotiation, on go-to-market and contracting strategy.
Recent growth in the NTAP designation alters dynamics for manufacturers considering pursuing the designation for new technologies.
A dynamic regulatory landscape, technological advancements, and investments in R&D offer new opportunities and challenges in kidney care.
An analysis presented at ASN’s Kidney Week 2023 found lower rates of home dialysis utilization among Medicare dual eligibles compared to non-dual eligibles.
New analysis finds that just over 40,000 Medicare FFS patients with end-stage renal disease (ESRD) elected to enroll in Medicare Advantage during the 2021 open enrollment period—the first time all ESRD patients had access to an MA plan. This enrollment shift increased the proportion of ESRD patients enrolled in MA from 23% to 30%.
Longstanding barriers have limited rates of kidney transplantation, but recent changes in the policy landscape may signal changes for patients and providers.
A district court’s decision to strike down the 2021 NBPP is the latest policy update on the use of copay adjustment programs, but questions persist.
The TDAPA supports payment and patient access to new therapies introduced to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS). CMS has continued to refine the payment designation through rulemaking. 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.
The recent FY 2024 IPPS final rule revised NTAP eligibility criteria for certain technologies. Applications for the FY 2025 NTAP cycle are due by October 17, 2023.
Avalere experts delve into the dynamic patient assistance program landscape, including copay accumulators and maximizers, alternative funding initiatives, and the repercussions of policy shifts such as the Inflation Reduction Act and state-level copay accumulator bans.
In CY 2024 rulemaking, CMS proposes operational clarification to the discarded drug refund policy finalized last year.
The revised guidance contains significant changes to the initial guidance released in March, but important outstanding questions remain.
Starting July 1, providers must report the JZ modifier on all claims for single-use Part B drugs when applicable, including for products billed with an NOC code.
19% of people enrolled in the US commercial insurance market will belong to a health plan that must count copay assistance toward patient cost sharing by 2024.
CMS recently convened stakeholders for a public HCPCS meeting to discuss billing, coding, and reimbursement of non-drugs and non-biological products.
Increased use of alternative funding programs has introduced new access challenges for patients, plans, and manufacturers for specialty therapies.
IRA negotiation eligibility criteria may impact orphan drug investment, affecting long-term innovation and patient access.
Stakeholders should consider the interaction of inflation-based rebates, AMP cap removal, and Medicare price negotiation in pricing and contracting strategies.
168 million individuals could lose access to $0 preventive services, creating pressure for healthcare stakeholders to address access and equity concerns.
IRA inflation rebates and drug price negotiation will impact drug launch prices in Medicare, with spillover effects in the Medicaid and commercial markets.
Ahead of Asembia 2023, Avalere experts discuss how the IRA and other regulatory changes will impact patient access and affordability.
Medicaid redeterminations will bring changes to individual prescription drug access. Manufacturers should consider the impact on patient support programs.
Guidance adds clarity on drug selection, maximum fair price application (MFP), evidence submission, and manufacturer engagement, but leaves questions on determining MFP.
Continued shifts in Medicare Advantage enrollment introduce new value-based care opportunities for patients with ESRD.
The IRA will reduce out-of-pocket drug costs (especially in Medicare Part D), increase the availability of marketplace plans, and expand access to vaccines.
Assessing barriers that impact patient access to obesity care and educating stakeholders on how to mitigate them can advance solutions toward improving care.
On November 4, Avalere presented a poster on disparities in wait times for kidney transplants at the American Society of Nephrology (ASN) Kidney Week 2022 conference.
The MPFS final rule implements the discarded drug refund requirement for certain single-use physician-administered drugs, presenting risks to manufacturers of these products.
President Biden’s executive order directs HHS to identify CMMI model options that could lower drug costs and promote access for Medicare and Medicaid enrollees.
The ESRD QIP is the first pay-for-performance program that penalizes dialysis facilities for not meeting performance thresholds.
Recent Medicare rulemaking requested stakeholder feedback on potential payment system changes to support access to therapies for patients on dialysis.
In recent years, payers and pharmacy benefit managers (PBMs) have been interested in implementing strategies that may reduce overall costs, such as the use of white bagging. However, provider and patient groups have raised concerns that these tactics may create access to care, cost, and safety issues. Legislation seeking to regulate this practice is on the rise in many state legislatures.
Tune into the second episode in the Avalere Health Essential Voice podcast miniseries focused on the evolving kidney care landscape. In this segment, our Market Access and Policy experts take a deeper dive into several of the policy and payment trends in the kidney disease space.
Tune into the second episode in the Avalere Health Essential Voice podcast miniseries focused on the evolving kidney care landscape. In this segment, our Market Access and Policy experts take a deeper dive into several of the policy and payment trends in the kidney disease space.
Tune into the first episode in the Avalere Health Essential Voice podcast miniseries focused on the evolving kidney care landscape. In this segment, our Market Access experts discuss the kidney disease patient population as well as treatment and payment systems this space.
Tune into the first episode in the Avalere Health Essential Voice podcast miniseries focused on the evolving kidney care landscape. In this segment, our Market Access experts discuss the kidney disease patient population as well as treatment and payment systems this space.
From policy and regulatory changes to COVID-19 and driving customer engagement, the healthcare environment continues to require healthcare stakeholders to adapt their strategies. How will you stay ahead of the trends impacting your business?
In light of proposed changes to the ESRD Treatment Choices Model to address health disparities, an Avalere analysis of Medicare claims found gaps in access to and utilization of specific dialysis-related services by patient race, ethnicity, and socioeconomic status.
An Avalere survey of 37 decision-makers at risk-bearing payer entities identified shifting trends and focus for coverage of and access to behavioral health treatments and services.
Medicare offers an add-on payment to facilities furnishing qualified new and innovative renal dialysis equipment and supplies via the Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES).
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.
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.
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.