Unbiased Analysis of Today's Healthcare Issues
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…
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…
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 On Wednesday, the FDA released draft guidance whereby they recommend the inclusion of patient preference information…
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…
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 The FDA has released a draft guidance on how it will regulate the new generation of wearable technology.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…
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…
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…
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…
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…
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…