Advanced Diagnostics: Innovation, Reimbursement, And Coverage Challenges
Executive Summary
Developers of novel advanced diagnostics tests face many challenges that dramatically constrain both innovation and the ability to provide new tests to clinicians and patients. Recently, planned changes in pricing detailed in the Protecting Access to Medicare Act of 2014, and new guidelines on evidence development have been put forward and in some cases adopted – will these recent changes address the challenges?
You may also be interested in...
Patents After Myriad: Can cDNA Cover All The Bases?
Life sciences attorneys expect the Supreme Court’s ruling that isolated DNA is not patentable will invalidate thousands of patents; it is unclear whether medicinal molecules isolated from nature or made synthetically are impacted by the decision.
Biotech Industry Fears Fallout From Supreme Court’s Myriad Ruling; PTO Offers Guidance
Supreme Court unanimously holds that DNA isolated from the human body cannot be patented but cDNA, which is created in a laboratory, can; Patent and Trademark Office tells examiners to reject product claims drawn solely to naturally occurring nucleic acids or their fragments.
California Bill To Age-Restrict Sales Of Diet Pills Further Along Than Other States’ Legislation
CA, MA and NJ legislatures remain in session with bills active proposing regulations similar to NY law effective 22 April requiring retailers, including online, to ask for proof of age when customers buying consumer health products containing ingredients labeled or promoted for weight loss and bodybuilding benefits appear younger than 18.