Unbiased Analysis of Today's Healthcare Issues

Archive for the 'Regulation' Category

Too much or too little regulation

Getting Obamacare subsidies may be too easy or too hard depending on your perspective. From MSN: In May 970,000 people had citizenship data errors in their Obamacare applications. As of August, 450,000 of those cases have been resolved, 210,000 are in progress and 60,000 new documents arrive every day. The 310,000 remaining applicants will receive […]

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How do states plan to control Obamacare premiums?

Obamacare mandates that individuals need to buy health insurance or else they will face a financial penalty. This threat, however, is not credible unless there are affordable health insurance options for most Americans. What are states doing to hold down health insurance rates in the ACA’s health insurance exchanges? A RWJF working paper provides some […]

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First biosimilar hits the market

Making a generic version of a single molecule drug is fairly straightforward.  Making a replica of a biologic treatment, however, is not.  Nevertheless, Congress signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) to create a fast-track approval process for biological products that are demonstrated to be highly similar an FDA-approved biological product.  These products […]

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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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