Kolton Gustafson assists clients in evaluating the impact of federal health policy developments on their business priorities and policy engagement strategies.
He uses his experience in government payment systems and reimbursement and his familiarity with provider perspectives to support engagements in cell and gene therapy, drug pricing, physician payment, Medicare reimbursement, and healthcare reform.
Prior to joining Avalere, Kolton was a senior analyst at Mass General Brigham where he monitored Medicare and Medicaid policy changes to assess financial impact on network hospitals. He also tracked the rule-making process for federal/state payment systems and drafted feedback to CMS on reimbursement and quality proposals. Prior to this, he was a research assistant at the Dana-Farber Cancer Institute in the Department of Cell Therapies, working with bone marrow transplant patients and collaborating on patient education efforts. He has also worked on health policy and communications for the American College of Physicians.
Kolton has an MPH in health policy from the Harvard T. H. Chan School of Public Health and a BA in political science from the George Washington University.
Authored Content
Join us for a webinar exploring the RNA-Based Therapy landscape.
Stakeholders consider implementation of a 340B rebate model to address duplicate discount risk.
Analysis highlights potential access barriers to a broad set of CAR-T therapies
Transparency disclosures could provide significant insight into pricing and rebating activities.
Medicare CAR-T payment remains stable; CMS proposed structural changes for New Technology Add-on Payments (NTAP).
In this installment of our 2024 Trends Influencing Rare Disease series, Avalere experts summarize key learnings for pharmaceutical companies to consider.
In this installment of our 2024 Trends Influencing Rare Disease series, Avalere experts explore policies shaping rare disease drug development and access.
The CGT Access Model will allow CMS to negotiate outcomes-based agreements on behalf of state Medicaid programs for CGTs, beginning with sickle cell disease.
Drug shortages have consequences for a broad range of stakeholders, and policy proposals vary in their ability to address negative impacts.
Payments to off-campus hospital sites affected by site-neutral payment policy amount to only 2.3% of Medicare outpatient spending.
Physician reimbursement for some services under Medicare FFS has declined, while payment increased for the same services in the hospital outpatient setting.
Medicare CAR-T payment remains stable, but changes to outlier payments and NTAP eligibility may create challenges.
Providers and pharmacies are two critical stakeholders that should prepare their own IRA strategies to adequately react to a changing landscape.
Plans preparing MA-PD and PDP bids for Plan Year 2025 should consider how Part D redesign will affect enrollee costs, plan payment, and market dynamics.
Section 340B of the Public Health Service Act requires significant discounts on outpatient drugs for “covered entities"—safety-net providers and programs.
Policy proposals for Medicare’s CAR-T inpatient reimbursement reflect additional cases and increase clinical trial payment.
Avalere’s assessment highlights a diverse set of over 200 products in development that could challenge payment models across care settings and payers.
CMMI releases long-awaited response to President Biden’s executive order on drug pricing with a directive for the Centers for Medicare & Medicaid Services (CMS) to develop three models.
Avalere found that from 2016 to 2022, hospitals undergoing mergers and acquisitions were more likely to have 500+ beds and to be a 340B covered entity.
Avalere analysis shows that a CMS policy to increase payment for 340B drugs, compared to alternative approaches, will result in lower payment to most hospitals.
To assess how changes in OPPS payment for reimbursement of drugs under the 340B program would affect hospital reimbursement and Medicare Part B beneficiary cost sharing, Avalere estimated the impact of increasing reimbursement for 340B drugs in Medicare Part B to ASP + 6%. The analysis finds that most hospitals would see overall payment decreases, while payments would be subject to higher cost sharing.
Avalere research finds that state Medicaid programs have taken a variety of approaches to coverage policy development for innovative therapies, highlighting opportunities for increased consistency and transparency.
The SCOTUS decision is the most prominent action related to the 340B program, but ongoing litigation among stakeholders and growing activity at the state level are catalyzing developments that could shape the 340B landscape
Join Avalere’s panel of market access and policy experts for a discussion on the growing cell and gene therapy (CGT) pipeline, an in-depth look at the unique opportunities and challenges these novel therapies present, and an overview of the many hurdles stakeholders need to navigate for success.
Policy proposals for Medicare’s CAR-T inpatient reimbursement build on market developments as bundled payment incorporates additional treatments.
Avalere analysis finds that 340B child sites and contract pharmacies are often located in less diverse and higher income ZIP codes than their disproportionate share hospital parent entities.
Analysis finds that patients face barriers to cell therapy treatments regardless of proximity to cell therapy treatment sites.
As manufacturers prepare for discarded drug rebates to begin in 2023, an Avalere analysis identified 39 drugs at risk for rebates totaling $151 million.
Amid recent policy focus on the accelerated approval pathway and questions regarding the pathway’s evidentiary standards and decision framework, Avalere reviewed the history, process, and use of this pathway to date and the potential future use of accelerated approval for pipeline products.
Finalized policy for Medicare’s CAR-T inpatient reimbursement builds on policies solidified in last year’s rulemaking. Looking ahead, stakeholders will continue to weigh the appropriateness of payment.
In November 2020, the Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to COVID-19 monoclonal antibodies for treatment of mild-to-moderate COVID-19 infection.
Policy proposals for Medicare’s CAR-T inpatient reimbursement build on policies finalized in last year’s rulemaking. Looking ahead, stakeholders will continue to weigh the appropriateness of payment.
Tune into another episode in the Avalere Health Essential Voice podcast series focused on disease education. In this segment, the first of several discussing cell and gene therapies, experts from our Policy and Market Access practices highlight many of the challenges surrounding these therapies from both the patient and payer perspective.
Tune into another episode of Avalere Health Essential Voice in our Start Your Day with Avalere series. In this segment, our policy experts discuss the topic of healthcare price transparency in terms of policy, compliance, and the potential impact of making previously confidential pricing information public.
Policy changes to Medicare’s CAR-T inpatient reimbursement set a precedent for high-cost durable treatments. Looking ahead, questions and concerns remain for pipeline cell and gene therapies that have high up-front costs.
As our healthcare industry rapidly evolves to address the COVID-19 pandemic, keep track of new resources and policies affecting patients and providers with the COVID-19 guide below.
Avalere assessed the impacts of select policies to expand low-income subsidy (LIS) eligibility under Medicare Part D