CMS denies Exact Sciences coverage
This article was originally published in The Gray Sheet
Executive Summary
Medicare agency will not cover Exact Sciences' PreGen-Plus stool-based DNA assay as an alternative to screening colonoscopy because it is not FDA-approved, the agency says April 28, confirming its earlier proposal. Other payers, including those represented by trade group America's Health Insurance Plans, support CMS' decision. FDA dealt Exact Sciences a warning letter in October stating that the test needed to undergo regulatory review and could no longer be provided out of laboratory partner LabCorp. Although stool-based DNA testing was recently added to American Cancer Society guidelines as a recommended screening test for colorectal cancer, Exact Sciences said in March it was pursuing strategic alternatives including a possible sale of the company (1"The Gray Sheet" March 24, 2008, In Brief)
You may also be interested in...
Exact Sciences seeks buyer
Colorectal cancer test developer hires investment banking firm Leerink Swann to assist its evaluation of "strategic alternatives," including the potential sale of the company. Announced March 18, the move follows CMS' Jan. 30 proposal not to cover the company's PreGen-Plus stool-based DNA screening assay technology, which is licensed to LabCorp for use as a testing service. Coverage was blocked as a result of an FDA warning letter sent to Exact Sciences last October, which said that the colonoscopy alternative required regulatory review (1"The Gray Sheet" Feb. 4, 2008, In Brief)
EU Parliament Stricter Than Council On Medicines And Medical Devices Packaging
The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.
Stay Or Exit? Global Health Players Ponder New China Trajectory
It's again the time of year when global CEOs descend on China's capital to discuss strategies. This year, however, the mood is different.