Tag: the dark report

Proposed Bill in Congress Would Regulate LDTs

CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both laboratory-developed tests and in vitro diagnostic test kits, changing current regulatory protocols for

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Medicare Demands Force PGx Lab into Bankruptcy

CEO SUMMARY: It’s becoming a familiar story. In Houston, a pharmacogenomics lab company started strong in 2011, then payments dropped sharply when Medicare issued restrictive new guidelines for PGx testing. Next, the Medicare administrative contractor handling the claims of CompanionDx Reference Lab canceled the lab’s registry and stopped paying most Medicare claims. In the wake

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ARUP Laboratories Earns CAP’s ISO 15189 Accreditation

CEO SUMMARY: Being accredited to this internationally recognized standard for quality and competence communicates to clients and prospective clients that one of the nation’s largest clinical labs is committed to the highest standards of quality. Clients already knew about that commitment but now have definitive proof, ARUP said. Also, lab administrators believed that gaining accreditation

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Labs Ask: Does PAMA Statute Prevent Legal Challenges?

SINCE MEDICARE OFFICIALS PUBLISHED the final rule for lab test market price reporting of private payer prices last year, clinical lab industry consultants and lawyers have raised serious criticisms of the rule.

The critics recognized that CMS officials wrote a final rule for the Protecting Access to Medicare Act (PAMA) that excluded from reporting large numbers

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