Congress

The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.

At the Personalized Medicine Conference this week, stakeholders historically at odds over lab test regulation said it is up to Congress to resolve the issue.

A tick-borne disease working group recommends the federal government explore using new technologies and repurposing existing ones to improve diagnosis.

The association is concerned that waived testing sites are operating with insufficient oversight and compromising patient safety, and is asking Congress to investigate.

The association says a provision requiring MACs to independently review LCDs from other jurisdictions before adoption is critical to the legislation.

Efforts by CMS and Congress to seek public comment on whether the Stark Law could be modified to accommodate value-based care have drawn divergent opinions from with the lab industry.

The lab association fears that the FDA's recent proposed framework would give the agency "virtually unfettered discretion" to regulate LDTs.

The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.

Lab, diagnostic and healthcare groups want Congress to enact legislation to modify PAMA and address  concerns about the way CMS collected data and established test prices.

The agency asked Reps. Bucshon and DeGette to consider the precertification program idea as they work on refining the draft of the Diagnostic Accuracy and Innovation Act.

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