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Stage 3 of meaningful use is shaping up to be the most challenging…for healthcare providers…elements that warrant attention are quality reporting, clinical decision support and security risk analysis… We have a long way to go until Stage 3 is finalized… new developments…is..decoupling of certification and meaningful use…We need to know which quality programs will require additional criteria for their programs and there is no way to anticipate that...

Centers for Medicare and Medicaid Services…issued guidance to all Medicare Part D plan sponsors regarding the Part D program's "any willing pharmacy" requirement…To comply with the AWP requirement,.. all…plans must have posted standard contracting terms and conditions… This new guidance should help reduce the likelihood of repeating the debacle of early 2015 that affected approximately 400,000 Medicare beneficiaries…

small drugmaker…may succeed…in winning approval for the first drug to boost women's sexual desire…team that founded Sprout Pharmaceuticals is not new to the..business …previous company, Slate Pharmaceuticals, sold an implantable testosterone pellet.. ran afoul of federal rules,… FDA sent Slate an 11-page warning letter…"I can't remember seeing a warning letter with so many examples of misbranding in it," said Fugh-Berman, who … signed a petition urging the FDA to reject Addyi (flibanserin)

Food and Drug Administration says Kardashian's social media posts violate federal drug-promotion rules…they don't mention side effects of Diclegis, which include sleepiness that can make it dangerous to drive or perform other activities that require mental alertness…

Prescription Drug User Fee Act authorizes FDA to collect fees from pharmaceutical companies to help fund the agency’s drug review work...provide additional funding for FDA to hire staff, improve systems, and establish a better-managed review process...enables us to do more timely reviews of human drug applications….The current legislation, PDUFA V, is set to expire in September 2017…ideas for further enhancements, including:

• Further efforts to involve the patient perspective in drug development processes;
• Building on FDA’s Sentinel System for active surveillance of safety issues for medical products, including expanding its use as a source of data;
• Enhancing regulatory science initiatives, including the use of patient-reported outcomes and biomarkers.

Even as stakeholders await the imminent release of the final updates to Stage 3 meaningful use, there's still widespread interest in delaying it... Fueling that fire is… Medicare Merit-Based Incentive Payment System, will attempt to bring all existing quality measures under one umbrella – but no one knows exactly how… details on this is driving physicians and vendors alike into a state of deep concern…

Massachusetts is joining the state-level push to tamp down drug prices. Lawmakers are proposing new disclosures about pharma's pricing decisions, just as they are in other states. But unlike California's move to limit price increases, for instance, Massachusetts could actually cap prices on specialty meds… state officials would have the power to limit prices...

Planned Parenthood fired back..against allegations that three Florida abortion clinics provided second-trimester abortions without proper licenses, seeking an emergency injunction against the state Agency for Health Care Administration "to protect women's access to safe, legal abortion."… grounds for the injunction,… AHCA was ignoring a 2006 agency rule, which defined the first trimester as "extending through the completion of 14 weeks of pregnancy…

India and the European Union are taking steps to end a trade row sparked by an EU ban on Indian pharmaceutical products that New Delhi responded to by cancelling talks on a free trade accord with its largest trading partner,.. both sides are working to end the row,…European Union said…the India-made pharmaceuticals that drug makers can avoid the ban by submitting fresh test results...

Department of Health and Human Services will fund 266 new primary care community health center sites in high-need areas nationwide to the tune of $169 million.. new sites, infused with Affordable Care Act funds, will increase care access for more than 1.2 million patients, according to HHS, building on $101 million the department gave to the program in May...