The Advocate

Volume 2, Issue 10


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October 2022

In This Issue:

Apply Now for Congressional Policy Fellowship
ASGCT Members Discuss CAR T Pipeline Issues with House Cancer Caucus
Inflation Reduction Act Implementation to Take Many Forms
Get to Know Your P&A Team!
Events
Policy News

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ASGCT Advocacy


Apply Now for Congressional Policy Fellowship

Applications are now open for the inaugural ASGCT Congressional Policy Fellowship! In partnership with AAAS, one applicant will be selected for a year-long policy fellowship in a legislative office on Capitol Hill beginning in the fall of 2023. Fellows will provide high-quality, science-based, independent guidance to federal policy makers and elevate awareness of the Society among policymaking circles. Take it from former science and technology Hill fellow and current ASGCT Government Relations Committee Chair Diane Berry, PhD – it’s not an opportunity to miss! Applicants must be an ASGCT member with a doctoral degree looking to gain skills at the intersection of science and policy.

A summary of application materials and FAQs are available, so take a look and apply today.

ASGCT Members Discuss CAR T Pipeline Issues with House Cancer Caucus

ASGCT thanks the Congressional Cancer Caucus co-chairs, Congressmen Higgins (D-NY), Kilmer (D-WA), Fitzpatrick (R-PA), and Kelly (R-PA), for supporting CAR T-cell therapies at a recent bipartisan briefing on innovative approaches to cancer care. ASGCT members and leaders explained the basics of gene and cell therapy, the patient experience, access considerations, and the future outlook and pipeline of CAR T treatments. You can watch the briefing on ASGCT’s YouTube channel.

This discussion was prompted in part by a recent report on manufacturing bottlenecks for CAR T therapies and how these have a downstream impact on patient access. The briefing introduced various issues facing advanced oncology therapies like CAR Ts, including the practical barriers for researchers, providers, and patients. Experts shared their experience with delays in time to treatment, funding challenges from NIH and private grants, and the need to modernize given the curative potential for these therapies. The Society is encouraged by the productive dialogue with Representatives and their staff on these important issues.   

Inflation Reduction Act Implementation to Take Many Forms

In August, President Biden signed into law the Inflation Reduction Act (IRA) of 2022 (HR5376). The bill included significant changes to how Medicare pays for drugs including:

  • Negotiation – new directives for HHS to negotiate with drug manufacturers on the cost of certain drugs with the highest expenditures in Medicare Parts B and D (while setting a limit on the price)

  • Rebates – requiring drug manufacturers to rebate to HHS the cost increases of any drugs over the rate of inflation on part B and D drugs (specific to Medicare prices only – commercial prices were excluded)

  • Part D reform – significant reforms to the Part D benefit, including changes to the amount of financial liability borne by beneficiaries, the government, manufacturers, and Part D insurers

ASGCT is watching the implementation of the Inflation Reduction Act, specifically what tools CMS has available to institute these changes and what if any impact they may have on genetic therapies. While the IRA has several clear directives from Congress, many provisions allow for CMS to take latitude with their implementation. It’s expected that CMS will need to provide additional guidance surrounding the negotiation and rebate provisions. This will be a process in the coming years, but work is already underway.

Turning a law into reality can be complicated, so here’s the breakdown: implementation of the IRA can be achieved through formal regulation (issuing a proposed rule, soliciting public comment, and then publishing the final rule), Health Plan Management System (HPMS) memos to inform of operational changes, and/or other creative federal guidance solutions. For directives that allow CMS more latitude, language within the IRA allows that “the Secretary of Health and Human Services shall implement this section, including the amendments made by this section…[through] program instruction or other forms of program guidance.” This provides HHS with authority to implement the statute outside of formal regulation. By contrast, in other laws, Congress may explicitly require rulemaking. Regardless of the tools they ultimately choose for to execute each provision, keep an eye out for CMS to release a number of guidance documents and rules in the coming year. CMS has already released several public resources related to the IRA implementation timeline, FAQ, and cost savings analysis.   

Both HHS Secretary Xavier Beccera and CMS Administrator Chiquita Brooks-LaSure have released statements on the Medicare Part B payment changes for certain biosimilars, one of the first Medicare provisions of the Inflation Reduction Act to go into effect. As more measures in the IRA are implemented, ASGCT will continue to engage on any that impact the gene and cell therapy space.

Get to Know Your P&A Team!  

As the cell and gene therapy field continues to grow, your ASGCT Policy and Advocacy (P&A) team is finding new ways to support research, development, and commercialization of these therapies through public policy channels. The goal of ASGCT’s P&A department is to proactively inform legislators and regulators about gene and cell therapies, and to develop policy relationships that will help promote broad patient access to approved therapies.

Margarita Valdez Martínez is the Director of the P&A department. Since joining ASGCT in March of 2022, Margarita has led the Society’s regulatory and legislative initiatives, bringing more than 10 years of experience on the Hill and more than 20 years working with associations. Margarita is also very active in the American Society for Association Executives and serves as chair of their public policy committee. At ASGCT she oversees the department’s four policy committees, Hill and Congressional outreach, regulatory interactions with FDA, event programming at the Annual Meeting and Policy Summit, and more!

Margarita is an avid runner but has not yet convinced the rest of the P&A team that a staff bonding 5K is a good idea. She leads through hard work, dedication to patients and science, and occasionally (with a little help from Baby Yoda) The Force.

Have a question about ASGCT’s policy priorities or want to get involved? Contact Margarita at any time at mvaldez@asgct.org or find her at any ASGCT event - likely in a brightly colored floral ensemble.

Events


Oct. 27 is the Final Day to Watch Policy Summit Sessions

We were excited to welcome nearly 300 in-person and virtual attendees to address the most important policy topics in the field at the 2022 Policy Summit. If you didn't catch every session, you can watch them all through Oct. 27. Registration will also stay open through that date.

You can also read our blog for an in-depth summary of each expert panel.

Policy News


2023

26th Annual Meeting

May 16-20 | Los Angeles, CA

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