EpiPen maker Mylan agreed to pay $465 million as part of a final settlement deal with the Justice Department, resolving claims that the firm overcharged the US government by misclassifying the epinephrine auto-injector as a generic product under Medicaid's Drug Rebate Program while it was being marketed and priced as a branded treatment. The settlement, which requires Mylan to reclassify EpiPen and pay rebates applicable to its new classification effective April 1, was criticized by several lawmakers who believe the settlement is too low.
HHS has postponed until July 2018 the effective date of a new rule that would have reduced ceiling prices for medications purchased by hospitals under the 340B drug discount program, and would have given the agency the authority to fine drug manufacturers that intentionally overcharge a hospital. HHS said the decision to delay the rule, which was supposed to take effect in April, will give the agency more time to consider alternative and supplemental regulatory provisions.
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Specialty access standards used by five state Medicaid agencies did not significantly improve access to specialist physicians, according to a study in JAMA Internal Medicine. By next year, the CMS will require state Medicaid programs to implement time and distance standards for managed care organizations to ensure Medicaid patients have adequate access to specialist physicians.
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The rate of drug overdose deaths among youths ages 15 to 19 in the US more than doubled between 1999 and 2015, with a 19% increase from 2014 to 2015, according to a report from the CDC's National Center for Health Statistics. Researchers also found that most drug overdose deaths in 2015 were accidental and caused by opioids.
Normal-weight postmenopausal women who consumed higher dietary energy density had a 10% higher risk of obesity-related cancers than those with a low-DED diet, according to a study in the Journal of the Academy of Nutrition and Dietetics. A diet rich in energy-dense foods also was associated with higher body mass index levels and greater waist circumference in this group.
A database analysis estimated 86% of more than 105,000 patients with cardiovascular disease could reduce their LDL cholesterol to less than 70 mg/dl just using statin intensification with ezetimibe added as needed. An estimated 14% would hit maximum levels of the oral treatments and need to move on to a proprotein convertase subtilisin/kexin type 9 inhibitor, according to the study in JAMA Cardiology.
Researchers from the University of Wisconsin found a 6% increase in office visits among providers that have adopted electronic visit programs because many doctors feel the need to see telemedicine patients in person, causing them to spend an additional 45 minutes on those visits. The study, based on health care encounters between 90 providers and more than 140,000 patients over five years, said e-visit programs also reduced the number of new patients seen by providers each month by 15% and did not contribute any "observable improvement in patient health" between users and nonusers.
Makers of brand-name drugs "game the system and game the rules" of a patient safety program to prevent generic-drug makers from obtaining adequate samples for equivalence studies, says FDA Commissioner Scott Gottlieb, who has vowed action to curb the practice.
The FDA has granted emergency use authorization for the CII-ArboViroPlex rRT-PCR test developed by researchers at Columbia University's Mailman School of Public Health. The test can detect Zika virus, chikungunya virus, West Nile virus and dengue virus.
The CMS reduced the number of locations mandated to participate in the bundled payment model on Comprehensive Care for Joint Replacement and canceled two others set to begin in January without proposing replacements, saying the rules associated with these models are too burdensome to providers.
There is no waste of any kind in the world that equals the waste from needless, ill-directed and ineffective motions.
Frank Bunker Gilbreth, engineer
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