Unbiased Analysis of Today's Healthcare Issues

Archive for the 'Regulation' Category

Narrow Networks

One of the ways health plans in the health insurance exchanges have been able to keep premiums down is through offering beneficiaries very narrow networks. By steering patients towards “efficient” doctors, premiums stay low. However, patients may worry that these “low cost” doctors are lower quality than those outside of the network. The tradeoff between […]

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Does your FitBit need to be FDA approved?

Right now, the answer is no, but in the near future, this may no longer be the case. The FDA has released a draft guidance on how it will regulate the new generation of wearable technology.  This guidance  says it will not regulate “general wellness” products like the FitBit. However, if the wearable cites health benefits for […]

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Regulatory Tsunami?

Medicare is working hard to make sure that doctors are efficiently providing high-quality care. Programs such as the Physician Quality Reporting System (PRQS) and the Value-Based Payment Modifier all are aimed to improve quality and lower cost. The downside of such programs, however, is that the impose reporting burdens on physicians. For instance, Medicare can […]

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Residency Hour Restrictions and Patient Outcomes

Residency has been a right of passage for physicians. Long 36-hour shifts mix with the excitement of new learning. However, recent regulations have now capped residency weekly hours at 80. Although patient medical care in the short-run may improve (because physicians are less tired), in the long run, are physicians exposed to as wide a […]

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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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