GenomeDx Biosciences bagged Medicare coverage for its postoperative prostate cancer diagnostic, putting its test in the hands of more patients and helping the company gain ground in a crowded market.
Sleep apnea devicemaker Inspire Medical updated investors on its commercialization strategy at the JP Morgan Healthcare conference. After a May PMA approval, the next big challenge for the Medtronic spinout is to secure reimbursement and ramp up commercialization, Tim Herbert, the company's president and CEO, said.
Boston Scientific has released one-year, retrospective data to demonstrate efficacy for its Precision Spectra Spinal Cord Stimulator in treating chronic lower back pain.
The U.S. House of Representatives this week passed a bill that specificially bans Medicare coverage of vacuum erection systems (VES) used to treat impotence.
A subsidiary of French in vitro diagnostics giant bioMérieux gained Medicare coverage for a new breast cancer test, a vital milestone necessary to compete in today's market.
The HHS Inspector General's office says the fine print isn't enough to safeguard against Medicare recipients' coupon use. Drugmakers have to do more--or risk violating antikickback laws.
A big no-no in the co-pay coupon world is Medicare. It's illegal to promote money-off coupons to Part D beneficiaries, because the government figures--rightly so--that the promos work to boost their brands over generics or other cheaper alternatives. But a new Inspector General's report points out that some 7% of seniors are using coupons to help cover their prescriptions.
Eli Lilly's Alzheimer's imaging agent, Amyvid, can't get very far sales-wise without coverage from the Center for Medicare and Medicaid Services (CMS). And as per a September decision, that's something it doesn't have. Now, however, it's fighting back, funding litigation it couldn't file itself.
Cancer Genetics isn't making money yet. But the New Jersey developer of DNA-based cancer diagnostics closed out its 2014 second quarter with smaller losses, some strategic acquisitions and a biomarker development partnership with AstraZeneca.
Novartis has to face a kickbacks lawsuit filed by the U.S. Department of Justice, which alleges that the Swiss drugmaker gave pharmacies discounts and rebates to boost sales of two drugs, a federal judge ruled Thursday.