Access, Equity, & Value-based Arrangements
Improving access to affordable diagnostic testing
The Fall 2020 OIG Final Rule, which went into effect in January 2021, added safe harbors for certain value-based arrangements (VBA) under the Anti-Kickback Statute (AKS), Stark and CMP, but specifically carved out clinical laboratories and pharmaceutical manufacturers from participating in VBAs under AKS.
This law means laboratories and providers are not allowed to work together on value-based plan design for testing, including complex tests for things like cancer, and patients get less as a result. Exclusion from the safe harbor creates a chilling effect where laboratories are not allowed to pursue innovative coverage models.
LAB has proposed simple legislation adding labs to the value-based arrangement safe harbor so laboratories will be able to participate in VBAs to increase access to tests, shorten time to diagnosis, and decrease costs.
LAB Sends Letter on Telehealth
In 2020 Congress enabled broad access to healthcare via telehealth through enacting waiver authorities in pandemic response legislation. On March 3, 2022, we wrote to Majority Leader Schumer, Minority Leader McConnell, Speaker Pelosi, and Minority Leader McCarthy requesting that the members extend these regulatory flexibilities beyond the public health emergency (PHE). The policy changes from 2020 were critical to ensuring a continuation of health care during a very disruptive time in history, and they led to a dramatic increase in the utilization of telehealth in the past two years. In a report released by the Department of Health and Human Services (HHS), the share of Medicare fee for service visits conducted via telehealth increased 63-fold, from approximately 840,000 in 2019 to 52.7 million in 2020.
We wrote in opposition to the requirement for a face-to-face visit prior to ordering a high-cost laboratory test via telehealth as included in H.R. 6202, the Telehealth Extension Act. and S. 3593, the Telehealth Extension and Evaluation Act. The in-person requirement has the potential to block legitimate and clinically-appropriate patient access to much-needed laboratory tests.
Telehealth has the potential to increase access to care, address health inequities, and improve health outcomes for patients through lung-cancer screening, at-home sample collection, and testing for sexually transmitted infections (STIs). We hope that Congress will recognize the importance of telehealth and work to extend the telehealth waivers granted during the PHE. However, we strongly caution against including guardrails into legislation until we fully assess all of the implications and understand the potential unintended consequences they will have on patient access, including laboratory services.