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Diagnostics Policy & Legislation

News on government policy and legislation impacting life science and diagnostics.

The groups have written draft recommendations and are now asking for public comment from pathologists and other stakeholders.

The proposed Medicines and Medical Devices Bill updates the framework for regulating IVDs following the UK's exit from the EU.

The bipartisan bill is backed by more than 250 organizations, but ACMG remains opposed, arguing that ordering tests is part of the practice of medicine.

Scheduled to go into effect next year, CMS' price transparency regulations could drive down reimbursements but also streamline billing for hospital labs.

A pair of lawyers familiar with the case said that while ACLA might not win the legal battle, its lawsuit could aid efforts to get a legal fix to the law.