Laboratories are pleased that CMS is opening the process of setting reimbursement for laboratory services, just as it is doing for physician services, which will give labs more say over pay rates.
The American Medical Association weighed in on the topic of clinical trial data sharing by recently adopting a resolution urging FDA to come up with ways for investigators to access safety data from industry-sponsored trials, an effort the drug and biologics industry say is unnecessary given data-sharing principles that have been developed and adopted by industry.
On July 1, enrollment doubled to about 120,000 dually eligible beneficiaries in the so-called duals demonstrations run in five states, and the vast majority of that increase is due to beneficiaries being automatically, or "passively," enrolled, according to a CMS official.
A new program to expedite medical device reviews by shifting data collection to the postmarket setting focuses on premarket approval (PMA) devices because the agency has more authority to compel evidence for those devices, FDA device center Director Jeff Shuren recently said, weighing in on what is viewed as the key component of the new program.
FDA's alternative proposed format for the updated nutrition facts label has garnered overwhelming support from consumer advocates and researchers, who say it will better inform consumers of how nutrients fit into their diet, but industry groups say the alternative format is too prescriptive and could lead to more consumer confusion.
Pharmacy compounders have joined with some patient advocates and providers to counter what they fear is a growing trend by pharmaceutical benefit managers and insurers to limit coverage of compounded drugs due to the rising cost of these customized medications.
Some patients advocates worry that the House Energy and Commerce Committee is favoring industry-backed patient groups as part of its new medical production innovation initiative, said Diana Zuckerman, president of the National Center for Health Research, which advocates consumer health and safety through medical research.
CMS on Thursday (July 3) proposed a physician pay rule that adds important details to the new, primary-physician-backed pay code for managing patients and that gives physicians more influence starting in 2016 over Medicare pay rates.
CMS is moving ahead with plan, put on hold last year, to shift hospital outpatient payments from the current hybrid approach to a more complete prospective payment system that bundles payments for certain primary procedures, the agency revealed in a proposed 2015 OPPS rule unveiled late Thursday (July 3).
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