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Posts Tagged ‘healthcare’

Court approves Vascepa® for off-label use despite pushback from FDA

pill_bottlesOn Friday August 7th, the Southern District Court of New York permitted Amarin Pharma to promote certain off-label uses of its 2012 FDA-approved drug, Vascepa®. The FDA has made it known that promoting uses of drugs that are not on FDA-approved labeling violates the Food, Drug, and Cosmetic Act (FDCA). This means that a manufacturer can promote its drug for its approved intended use, but a true and non-misleading promotion of an off-label use is considered misbranding. Doing so is prohibited conduct, and could result in penalties and criminal prosecution. Read more…

Report cites criminal attacks as primary cause of healthcare data breaches

healthbreachIn the fifth annual Ponemon Institute privacy and security report, cyber attacks were listed as the top cause of healthcare breaches. Officials studied privacy and security trends for healthcare covered entities and their business associates. Over the course of the five years Ponemon has been publishing its annual breach report, criminal activity has grown 125 percent. Officials at the institute discovered 69 percent of healthcare organizations uncovered the breach via an audit or assessment. Forty four percent were discovered by an employee, while another 30 percent were found after a patient complained.

Ponemon stated, “Historically, the main cause of the data breach was the negligence or incompetence or system glitches within the organization, not necessarily criminal activity. This year, criminal activity was the number one cause.” Forty-five percent of respondents in the report claimed criminal attacks were directly responsible for Read more…

Takeda Pharmaceutical agrees to settlement concerning diabetes drug Actos

gavel_pillsOn Tuesday April 28, Japan’s Takeda Pharmaceutical agreed to a $2.4 billion settlement involving thousands of lawsuits from patients and their family members claiming that the company’s diabetes drug Actos was responsible for causing bladder cancer. Takeda stated that this settlement would resolve the majority of product-liability lawsuits linked to Actos, but a $2.7 billion charge against earnings will be necessary to cover the settlement and costs for defending the outstanding cases.

Takeda, however, did not admit liability. The company’s reason for settling was to “reduce the uncertainties of complex litigation,” and stated that the claims brought forth in the lawsuit were without merit. Takeda also added that Actos’ benefits offset any risks caused by the drug, which is sold in the United States and other countries. Read more…

Rising healthcare industry brings stand-alone tail coverage to mind

March 19, 2015 Leave a comment

money_healthWhile technology, energy and other industry sectors often capture the headlines in the financial press and in the media, health care companies are a major economic force within the U.S. economy and growing. According to The World Bank, health care spending between 2010 and 2014 accounted for nearly 18% of U.S. GDP. This number is only expected to grow in the decade ahead. While some have argued that the PPACA will slow this trend, I find little evidence that it will do so in any meaningful fashion. All of this means that health care dollars spent in the U.S. will claim an increasing portion of our GDP. Read more…

Blue Cross of MA expands pay-per-performance system to PPO markets

dr_patientThe spotlight in local health care news this week shines on Blue Cross Blue Shield of Massachusetts and its continued efforts toward performance-based payment reform for doctors. This system that pays doctors based on how well they care for patients will expand to include more than one million members. For patients, this should mean a decrease in office visits and unnecessary testing, and an increase in individualized health management and post-procedural care.

Currently, a fee-for-service system accounts for 66 percent of the Massachusetts market. Specialists agree, this traditional practice – one where doctors are paid per patient visit, needle prick and procedure – encourages unnecessary testing and overbooking appointments, often under prioritizing patient health. Read more…

House votes to repeal Affordable Care Act

obamacare_repealSince the law originally passed in 2010, many Americans have been closely watching the changing political environment to see what changes happen with the Affordable Care Act (ACA or Obamacare). Employers are watching Washington with an invested interest to see what rules they will need to comply with and which rules might change.

The most recent midterm election resulted in a swing of control to the GOP. Clients are asking what impact this change might have on attempts to repeal the ACA. Regardless of the GOP’s dominance in Congress and in the House of Representatives, WGA believes that Obamacare is not going away anytime soon. Read more…

Tort reform – hype vs. reality

February 26, 2015 Leave a comment

med_mal_op_edAsk any healthcare provider about what goes on during the arduous task of completing a medical professional liability renewal and you’re bound to hear about insurance market conditions and the state of insurance renewals. Everyone from politicians (both local and federal) to advocacy groups and providers themselves seems to be commenting about how the “crisis” with medical malpractice insurance inhibits the performance of good medicine. The phrase “defensive medicine” was a phrase rarely mentioned until recently. Now, it’s permeated the nomenclature of both patients and providers alike. However, an objective review of the medical professional liability insurance market would find the claim of a “crisis” to be unfounded, or incomplete at best. Read more…