Mylan agrees to pay $465M to settle EpiPen misclassification claims | HHS delays rule that would lower ceiling prices for 340B drug program | Study: Specialist access no higher using state standards
August 18, 2017
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Mylan agrees to pay $465M to settle EpiPen misclassification claims
Mylan agrees to pay $465M to settle EpiPen misclassification claims
(Joe Raedle/Getty Images)
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.
Reuters (8/17),  The Hill (8/17) 
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HHS delays rule that would lower ceiling prices for 340B drug program
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.
Modern Healthcare (tiered subscription model) (8/17) 
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Connect your health plan to today's digital sales platforms
Vericred partners with carriers across the nation to deliver benefit and rate, provider-network and formulary data to digital sales platforms that are transforming the way health insurance and employee benefits are quoted, sold and enrolled. Learn more about how Vericred can enable your health plan's data distribution.
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Providers & Suppliers
Study: Specialist access no higher using state standards
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.
Healio (free registration) (8/15) 
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What if you didn’t wait to use Social Determinants of Health Insights?
Join our experts for a complimentary webinar. Learn how the use of social and economic factor points can be leveraged for insights to assess risk for members with or without claims data. Register for the August 29th webinar.
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Medical Update
CDC reports rising teen drug overdose mortality rates
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.
NBC News (8/16),  CNN (8/16),  HealthDay News (8/16) 
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Study: Diet high in energy-dense foods raises cancer risks
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.
MedPage Today (free registration) (8/17) 
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Study: 86% of patients with CVD could hit LDL goals with oral meds
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.
Medscape (free registration) (8/14) 
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Emerging Trends
Study: Telemedicine may lead to more office visits
Study: Telemedicine may lead to more office visits
(Carsten Koall/Getty Images)
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.
Healthcare IT News (8/16) 
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Health Insurance Plan Company News
New Report: Straight Talk on Member Engagement
What are the four key rules of member engagement for inspiring the behaviors you desire? Get the latest tips for supporting loyalty at member on-boarding and beyond. Learn what some payers are doing to engage members more successfully than others.
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Solutions Provider News
Pharma News
FDA commissioner vows action to boost generic-drug development
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.
USA Today (8/15) 
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Zika assay granted emergency use authorization by FDA
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.
GenomeWeb Daily News (free registration) (8/14) 
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Policy Watch
CMS scales back value-based care models
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.
Modern Healthcare (tiered subscription model) (8/16) 
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AHIP News
Earn your PAHM® with AHM250
Master the concepts behind today's health insurance business models with Healthcare Management: An Introduction (AHM 250) and earn your Professional, Academy for Healthcare Management (PAHM) designation with one intensive course. Lay the groundwork for the remaining Academy for Healthcare Management courses. Learn more and sign up today.
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Health plans: Social needs matter
AHIP President and CEO Marilyn Tavenner discusses the importance of socioeconomic conditions, like places to stay cool in summer, that influence people's health and well-being. Watch the video.
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Must-attend webinars. Register today
Sept. 19, 1 to 2 p.m. ET, "Leveraging Big Data Technology for Clinical Data Integration" substantiates a real world clinical data integration approach leveraging big data and yielding ideal infrastructures across structured and unstructured datasets. Sept. 20, 1 to 2 p.m. ET, "Algorithm-driven care to streamline utilization management" validates best practices in standardizing decision-making based on evidence-based clinical content.
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