Will the FDA go back on a decision it made years ago? I am referring to a story that has a lot of buzz: whether or not the FDA will take recommendations from its advisory committee and change the restrictions on Avandia (rosiglitazone). Avandia was approved in 1999 and shortly became the top-selling type 2 diabetes medication in the world. In 2010, data from a number of trials convinced the FDA to severely restrict the medication through implementation of a Risk Evaluation and Mitigation Strategy (REMS), while Europe banned it entirely.
So last week it was all doom and gloom about Pioneer ACOs.
The buzz in health care wonkdom was all about 9 of the 32 organizations defecting from a program supposedly designed for the best and brightest of American health care organizations — with maybe more to follow. Accepting downside risk was just too perilous. Lags in getting data from Centers for Medicare & Medicaid Services (CMS) were undermining cost and quality control efforts. And the contradiction of being responsible (aka accountable) for the costs of Medicare enrollees but having no direct control over where they receive care — a central feature of the ACO model — was simply untenable.
But this morning CMS attempted to change the doleful Pioneer ACO tune with a long-awaited announcement of cost and quality results from 2012, the first year the Pioneer ACOs were in operation.
Everybody else always knew that they weren’t really invincible, and now they seem to be grasping that fact as well. More than 70% of people 30 and younger say that having health insurance is very important to them, according to a poll by the Kaiser Family Foundation (http://tinyurl.com/insured-youth). These have historically been called the “young invincibles” because of their belief that chances are slim that they’ll suffer serious illness or injury and that, therefore, they don’t need to buy insurance.
Though the Department of Health and Human Services and Department of Labor issued final regulations concerning “Incentives for Nondiscriminatory Wellness Programs in Group Health Plans,”1 employers and health plans must still navigate unresolved inconsistencies between the Affordable Care Act (ACA) and the Americans with Disabilities Act (ADA).
In the first of several posts, Tom Ewers and Munzoor Shaikh of West Monroe Partners discuss the dynamics of health care payer mergers. Here, they describe how success hinges on several key ingredients in the stages before closing — the pre-close stage.
Research from the New England Healthcare Institute has the world rethinking what the next great advance in health care will look like. While many of us are only now beginning to hear the noise about medication nonadherence, health care leaders are already hot on the trail to finding effective ways to reduce nonadherence.
One thing is clear from the decision the Supreme Court rendered Monday: There’s going to be more litigation. The Supreme Court ruled 5–3 that the Federal Trade Commission (FTC) has the right to examine “pay for delay” deals between brand and generic manufacturers on antitrust grounds. It did not support the FTC’s contention that pay-for-delay deals are inherently illegal.
Pay-for-delay is the term coined to describe settlements reached between brand manufacturers and generic manufacturers where the brand manufacturer pays the generic manufacturer not to challenge a patent.
At a recent Grand Rounds, a leading clinician medical ethicists told of a meeting with members of the family of a critically ill 6 week old boy who had been in a neonatal intensive care unit since birth. At the meeting were the mother and father, both sets of grandparents, an and aunt and uncle, three members of the hospital ethics committee and physicians and nurses who were caring for the seriously ill child. The one question that our speaker posed to the parents and any other family members that chose to offer a response:
"For what do you hope for your son/ grandson/ nephew?"
A health care consultant and member of Managed Care magazine’s Editorial Advisory Board says that under health reform, pharmacies will have a greater need to balance clinical and economic considerations. The less expensive drug might not always be preferable.
New prescriptions were given to 232 patients from April to August 2010 at St. Michael’s Hospital in Toronto. Twenty-eight percent exhibited primary non-adherence at 7 days after discharge; 24 percent at 30 days. Perhaps more surprising is that patients discharged to home had a better adherence rate (26 percent) than those discharged to a nursing home (43 percent). There were no significant demographic differences between the adherent and non-adherent groups. Participants were all 66 or older; the average age was 78.