LAB held our Summer Coalition Meeting on Thursday, May 30th. We were joined by Avalon Healthcare Solutions who explained how lab value interpretation, comparison to diagnosis and management, and informing providers on the latest science can improve quality, cost, and care equity.

An update on LAB activities, including the FDA final rule on LDTs, PAMA delay, and value-based care was also provided.

Missed the meeting and want to learn more? Please contact bmeeks@labcoalition.org or smcgurl@labcoalition.org

Join LAB and the Association for Molecular Pathology on Tuesday, May 7, at 1 p.m. (EST) for a conversation about the FDA's LDT Final Rule to regulate LDTs as medical devices.

This rule will impact patients' access to innovative tests, lab operations, and pathologists' ability to practice medicine. Below is an overview of what will be discussed:

• LDT Rule Overview

• IVD Definition

• Four-Year Phase In

• Continued “Enforcement Discretion”

• LAB Comments

• AMP & other Allied Organization Comments

Missed the meeting and want to learn more? Please contact bmeeks@labcoalition.org or smcgurl@labcoalition.org

LAB will be holding our first open meeting of the year on February 15 at 1:00 PM ET. Grace Graham from the House Energy and Commerce Subcommittee on Health will be joining us as a guest speaker. Our agenda includes a recap of LAB’s efforts in 2023, an outlook on 2024, and LAB’s priorities for the upcoming year.

Missed the meeting and want to learn more? Please contact bmeeks@labcoalition.org or smcgurl@labcoalition.org

LAB will be holding our final General Meeting of 2023 on November 15 at 2 pm ET. We will be joined by guest speaker Conor Sheehey who serves as Senior Health Policy Advisor on the minority staff of the Senate Finance Committee. The agenda also includes a 2023 EOY outlook, LAB year in review, Congressional action on PAMA cuts, FDA LDT rule, and value-based safe harbor for labs in AKS.

Missed the meeting and want to learn more? Please contact bmeeks@labcoalition.org or smcgurl@labcoalition.org

Earlier this summer, the U.S. Department of Health and Human Services (HHS) released its final rule implementing information blocking penalties for some actors, and a rule impacting providers is expected this fall. These rules, required by the 21st Century Cures Act, establish statutory penalties of up to $1 million per violation for developers and exchanges as well as “disincentives” for providers. Under the rule, laboratories, pharmacies, pharmacists, community health centers, and community mental health centers are considered providers and are subject to disincentives.

So, how do these rules impact your work at laboratories, pharmacies, pharmacists, community health centers, and community mental health centers? This webinar is your chance to engage directly with leadership at the Office of the National Coordinator for Health Information Technology (ONC) and learn more about the thinking behind the Cures Act from the person who wrote it.

Brett Meeks, the author of the Cures Act, now the Executive Director of the LAB Coalition and the Health Innovation Alliance will lead Micky Tripathi, Ph.D., M.P.P., National Coordinator for Health Information Technology at HHS in a discussion about how you can ensure you’re following the rules to avoid costly penalties before taking questions from participants.

Missed the event and want to learn more? Please contact bmeeks@labcoalition.org or smcgurl@labcoalition.org

LAB will be holding our first General Meeting of the year on March 15 at 2 pm ET. We will be joined by Colin Goldfinch from the CMS Center for Consumer Information and Insurance Oversight (CCIIO). Our agenda also includes a discussion on the No Surprises Act, a 2023 overview along with LAB priorities for the year, PHE expiration, Committees in the 118th Congress, a prior authorization update, and information blocking.

Missed the meeting and want to learn more? Please contact bmeeks@labcoalition.org or smcgurl@labcoalition.org

Join the LAB Coalition for our September General Meeting. Guest speaker, Dr. Jason Bush, Executive Vice President, Product at Avalon Healthcare Solutions, will lead us in a preview of the 2022 Lab Trend Report. We will also hear from the LAB Coalition’s Executive Director, Brett Meeks, who will discuss how federal interoperability rules apply to labs and what that means going into the next year.

Agenda:

·       Welcome and Introductions

·       Guest Speaker: Jason Bush, Ph.D., MBA

o   Preview of 2022 Lab Trend Report

·       LAB Coalition One-Year Review

·       Interoperability Rules and Labs

·       Work Ahead

·       Adjourn

Dr. Bush has more than 20 years of experience in leadership positions in venture capital-backed healthcare and life sciences companies. In his current position at Avalon Healthcare Solutions, he is responsible for product strategy, design, and management.

Brett Meeks, Executive Director of the LAB Coalition, has more than a decade of experience working on health care issues, including eight years on Capitol Hill where he served as Deputy Health Policy Director on the Senate HELP Committee where he wrote, negotiated, and oversaw the passage of several federal health care laws, including the 21st Century Cures Act.

Missed the meeting and want to learn more? Please contact bmeeks@labcoalition.org or smcgurl@labcoalition.org

Please join us for the LAB Coalition August meeting featuring a special guest speaker from the Senate Health, Education, Labor, & Pensions (HELP) Committee staff. Topics on the agenda include: 

• Medical Necessity & Prior Authorization

• Access, Equity & Value-Based Arrangements

• Build Ideal Prior Authorization Framework

• Anti-Kickback Statute Safe Harbor for Labs

With the persistence of the COVID pandemic, lab-related policy continues to be pushed into the forefront of national media and policy discussions at every level of government. The time is ripe for our community of experts to engage. We hope you can join us as we discuss policy and strategy to guide us moving forward. 

Missed the meeting and want to learn more? Please contact bmeeks@labcoalition.org or smcgurl@labcoalition.org

Please join us for a kick-off meeting of the Laboratory Access and Benefits (LAB) Coalition on July 8, 2021 at 2:00 p.m. EST. Representatives from the Food and Drug Administration will join the meeting and provide brief remarks. We look forward to discussing opportunities in lab policy and hearing from participants on these important issues.

Agenda:

• Welcome and Introductions

• Brief Remarks from FDA

  • Elizabeth Hillebrenner, Associate Director for Scientific and Regulatory Programs, Center for Devices and Radiological Health

• Brief Remarks from Avalon Healthcare Solutions CEO, Dr. Bill Kerr

•  Review and Discussion of Four Proposed Policy Focus Areas

  • Cost and Reimbursement

  • Medical Necessity and Prior Authorization

  • Oversight and Regulatory Authority

  • Access, Equity, and Value-based Arrangements

•  Joining LAB: Membership Overview

• Wrap-up & Next Steps

Missed the meeting and want to learn more? Please contact bmeeks@labcoalition.org or smcgurl@labcoalition.org