Unbiased Analysis of Today's Healthcare Issues

Archive for the 'Regulation' Category

Incentives for investing in “off label” trials

Aaron Carroll of the Incidental Economist draws on a column from his colleague Austin Frakt in The Upshot to explain why there is not more research into off-label uses of patented or generic drugs.  

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Off Label Drug Use

Approximately one in five prescriptions for drugs in the US are for off label use.  In some cases, this may be inapprorpiate as there is typically limited clinical evidence supporting off label use.  In other cases, off label use is approrpiate.  Clinical trials rarely enroll children or pregnant women and thus medictions are often not […]

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Will value-based pricing be coming to the U.S.?

The answer may be yes.  One of the big inpediments to value-based pricing of pharmaceuticals was that any discount given to any single organization based on outcomes needed to be reflected in the Medicaid price.  Since outcomes are subject to random noise, there will inevitably be health plans that end up getting a low price due to worse than expected […]

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Brexit = upheaval for drug makers

Will the European Medicines Agency (EMA) need to re-located after Brexit? According to a Reuters story, the answer is yes. The EMA is a London-based organization that approves treatments for all EU countries. As the UK leaves the EU, however, EMA is expected to have to relocate. 600 individuals work for EMA. More important is […]

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What is the FDA doing about opioids?

The FDA is planning to put additional scrutiny on the use and approval of opioids in order to prevent opioid abuse and addiction.  Here is their plan: Re-examine the risk-benefit paradigm for opioids and ensure that the agency considers their wider public health effects Convene an expert advisory committee before approving any new drug application for an […]

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The cost of allowing kids to remain dependents up to 26 years

Many of the provisions of the Affordable Care Act include provisions requiring health insurers to do certain things.  Variability of premiums are regulated, certain services are mandated (e.g., free annual check-up) and minimum benefits packages are set on the health insurance exchanges.  One seemingly innocuous provision of the ACA is that children are allowed to remain […]

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FDA to Consider Patient Preferences

Typically, the FDA evaluates drugs and devices based on whether they are safe and effective. Patient treatment preferences play little to no role in whether a drug or device is approved by the FDA. However, times are a changing. On Wednesday, the FDA released draft guidance whereby they recommend the inclusion of patient preference information […]

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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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