- Stage 3 meaningful use: What’s next? (healthcareitnews.com)
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...
- Planned Parenthood Seeks Injunction After Abortion Allegations (health.wusf.usf.edu)FL Planned Parenthood Inspections Find Violations (health.wusf.usf.edu)
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…
- Health system cleared in data breach lawsuit (healthcareitnews.com)
An appellate court has cleared Advocate Medical Group of wrongdoing in a class action lawsuit alleging the organization failed to protect patient data following a massive HIPAA data breach… The fact that two plaintiffs to date (out of those four million) have received notification of fraudulent activity, i.e., have suffered actual injury arising…does not show that plaintiffs here face imminent,..impending, or a substantial risk of harm..
- Diabetes could ‘bankrupt the NHS’ after 60% rise in number of cases, charity warns (independent.co.uk)
An extra 1.2 million people have diabetes now than a decade ago, according to new figures – leading to a warning that its cost could "bankrupt the NHS" (National Health Service) ..The number of those living with the condition has soared by 59.8 per cent since 2005, meaning more than 3.3 million now have it… Prescriptions for diabetes now take up 10 per cent of GP (General Practioner) practices’ annual prescribing budget in England. A total of 47.2 million items were prescribed in the last financial year, at a cost of £860m.($1.34b)...
- Kicking off the PDUFA VI Reauthorization Process (blogs.fda.gov)
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.
- CMS issues guidance on AWP compliance (drugstorenews.com)
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…
- Will delaying Stage 3 meaningful use help with MIPS? (healthcareitnews.com)
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…
- Sen. Manchin blasts FDA for OxyContin approval for children over 11 (wvva.com)CDER Conversation: Pediatric pain management options (fda.gov)
Senator Joe Manchin says he is "ashamed" and "disgusted" with the Federal Drug Administration's recent decision to allow physicians to prescribe OxyContin to children. Manchin calls the decision "a horrifying example of the disconnect between the FDA approval process and the realities of the deadly epidemic of prescription drug abuse are having on our communities." He is calling for a Senate investigation.
- Patients Strongly Oppose Prescription-Only Pseudoephedrine (pharmacytimes.com)
..vast majority of patients wants continued access to OTC medications containing pseudoephedrine and opposes making the drugs prescription-only…This conclusion comes from an Asthma and Allergy Foundation of America survey of more than 2000 adults … who experienced cold, cough, flu, asthma, or allergies…71% of patients unfavorably view pharmacies and grocery stores that remove OTC medications containing PSE from their shelves..
- India, EU working to end trade huff over generic drugs (newsdaily.com)
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...



