Unbiased Analysis of Today's Healthcare Issues

Archive for the 'Regulation' Category

How the FDA evaluates Cancer Drugs

The Food and Drug Administration (FDA) reviews and approves all drugs. But what criteria does the FDA use to evaluate new drugs? Namely that they are effective (i.e., improve health outcomes) and safe (i.e., have limited adverse health events). In a 2007 guidance document from the FDA’s Center for Drug Evaluation and Research (CDER) and […]

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Does licensing increase prices for dentists?

Clearly the answer is yes. For many basic tasks, dentists and dental hygenists may perform task of similar quality. However, in some states, dental hygenists are not allowed to perform these tasks. A paper by Wing and Marier find the following: United States, occupational regulations influence the work tasks that may legally be performed by […]

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Regulating 23andMe

A number of companies, such as 23andMe, allow individuals to sequence their own genes in order to attempt to determine if they have an elevated risk for certian diseases. This sector has largely been unregulated…until now. The Economist reports, On November 22nd the FDA…sent a stern letter to 23andMe, a genetic-testing firm. Despite “more than […]

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What is value-based pricing?

Where has public policy gone in the last few years?  Popular policies include move towards more bundled payments, the creation of accountable care organizations, additional funding for comparative effectiveness research (CER), evidence-based medicine (EBM) and value-based purchasing programs that link payments to various quality metrics. With health care costs rising, payers are looking to decrease […]

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California Hospitals Charge Fair Prices to the Uninsured

Why is that?  Because in 2006 California passed the Hospital Fair Pricing Act.  Melnick and Fonkych (2013) describe the bill as follows. The Hospital Fair Pricing Act…mandated that hospitals develop formal, written financial assistance policies and limit the  prices they charge uninsured patients with low to moderate incomes…Under the law, hospitals must limit the amounts they collect from […]

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The Trade-offs of Healthcare Regulation

When a problem appears, politicians often call for more regulation. Wall Street collapses? Frank-Dodd. Health insurance doesn’t cover pre-existing conditions? PPACA. Need to protect patient privacy? HIPAA. But are there downsides to increased regulation? A paper by Cotet and Benjamin (2013) examines just this question. In particular, they examine the welfare implications of regulations that […]

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The end of the FDA?

When Alfred Caronia worked for a drug company, he promoted some drug’s off-label use. The Department of Justice did not take kindly to Caronia’s behavior and sued him for violating the Food, Drug, and Cosmetic Act (FDCA). He was convicted, but appealed the conviction. Caronia argued that this commercial speech is protected by the first […]

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What does a NICE health economist do?

What role do health economists at the UK’s National Institute for Health and Clinical Excellence (NICE) play and how do they conduct their cost effectiveness analyses for new treatments? I answer this question today based on NICE’s own documents.  According to their guidelines manual, the role of the health economist in clinical guideline development is to: […]

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How to Survive a Plague

Last weekend, I watched the movie How to Survive a Plague.  The movie discusses the AIDS activist group ACT UP (AIDS Coalition to Unleash Power).  Although I am not a  movie critic (you can see reviews by professional critics here), I do want to discuss one key issue that the move discusses: should the FDA liberalize its […]

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Who gets hurt when Americans buy drugs in Canada?

A few years ago, changing federal laws to lower drug prices was a key political issue. Some proposed allowing Medicare to negotiate lower prices from drug manufacturers and others recommended allowing U.S. citizens to import drugs from lower-priced developed countries such as Canada. These policies would certainly reduce drug prices, however, lower prices could also […]

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