Latest Draft of Hatch IVD Bill Contains New Regulatory Proposals; Pricing Reforms under Discussion
July 06, 2011
Latest Draft of Hatch IVD Bill Contains New Regulatory Proposals; Pricing Reforms under Discussion
The latest iteration of a bill being drafted by Republican Senator Orrin Hatch includes new proposals to bring "follow-on" diagnostics to market and a process for grandfathering in already-commercialized IVD products. Other issues, such as the development of a market-based pricing model for advanced personalized diagnostics, are still under consideration.
Full-text access for premium subscribers only.
Existing premium subscribers login here.
New to GenomeWeb? Register here quickly.
New to GenomeWeb? Register here quickly.
Related Stories
- Texas Congressman Drafts Bill to Keep Lab Test Oversight out of 'FDA's Lap,' Expand Authority of CMS
October 19, 2011 / Pharmacogenomics Reporter - Lab Group Tells CMS That Medicare Contractors Aren't Paying for MDx Tests With New CPT Codes
April 1, 2013 / GenomeWeb Daily News - CMS Stance on Reimbursement of Multi-Analyte Algorithm Assays Raises Industry Concerns
September 19, 2012 / Pharmacogenomics Reporter - Lab Group to Ask Congress for Statutory Changes to Keep LDTs Under CLIA
May 4, 2011 / Pharmacogenomics Reporter - FDA Official Offers Agency's Take on Protein IVDMIA Mock 510(k) Submissions
January 14, 2011 / ProteoMonitor