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CMS to form inter-agency group to review Stark law The CMS plans to convene an inter-agency group to figure out how to minimize the regulatory barriers of federal anti-kickback laws, which have slowed providers’ move to value-based care, according to CMS Administrator Seema Verma. The CMS, HHS’ Office of Inspector General, HHS’ General Counsel and the Department of Justice will participate in the group. The ... Read More
Conflict of interest concerns keep CDC's Fitzgerald away from yet another meeting with Congress A Senate health committee held the first of two hearings Wednesday over the current state of the nation’s readiness to address public health emergencies, which led to calls to improve the reliability of data collected during and after disasters. But before senators could tackle some of those pressing issues, they first had to contend with the ... Read More
House to consider bill that would define 340B-eligible patients The odds in Congress’ big-money fight over 340B drug discounts are shifting against hospitals with a soon-to-be-introduced bill that would limit the number of patients qualifying for the discount. Rep. Chris Collins, New York Republican and ardent critic of the recent 340B expansion, is gearing up to unveil the bill that has support from his party’s ... Read More
CMS: New lock-in policy could turn tide in opioid fight The CMS hopes it will soon have a new tool to combat the opioid epidemic: the ability to lock-in beneficiaries to a single prescriber of frequently abused drugs, a senior agency official told Congress on Wednesday. The CMS has proposed a policy to prevent Medicare beneficiaries from obtaining prescription drugs from multiple doctors or pharmacies, locking ... Read More
Pediatric Gene Therapy The European approvals of Glybera® in 2012 and Strimvelis® in 2016 seem likely to be the vanguard of the therapeutic revolution heralded by the decoding of the human genome. Both of these treatments originated from academic centers of excellence and became the subjects of agreements with pharmaceutical companies (Uniqure/Chiesi and GSK, respectively) with the experience ... Read More
The Case for Intelligent Design (and Infrastructure) in Life Science Biologics R&D New White Paper from IDC Health Insights examines industry trends, new challenges and emerging capabilities in biologics. With many recent blockbuster patents expiring, the pharmaceutical industry finds itself in the middle of a transformation. Leading life science organizations are updating their business strategies to include the pursuit of a new market opportunity – the discovery and development ... Read More