Apples to Apples Regulatory Approval Times No Less In Europe

A study recently appeared in the NEJM comparing the average approval times for innovative, high risk medical devices in the U.S. and in Europe. It appears for new devices the approval times are similar overall. I think the key is that these are innovative (new technology) rather than more of the same. The authors of this Perspective study, “based their case on data showing that reimbursement decisions figure as prominently as regulatory ones in delaying—or expediting—patient access to innovative, high-risk devices.”

Another standard test is questioned after a study shows there is little benefit for the patient

Grant money is growing for studies examining how we spend our health care dollars. A short while back two different studies questioned the wide spread use of mammography. Last week a study questioned the growing use of imaging in stage 4 Medicare cancer patients. As pressure grows to decrease the cost of health care more studies will question the way we conduct health care as we try to determine a value proposition for each and every test conducted.

Study Finds Advanced Imaging Growing Fastest in Stage 4 Cancer Patients.

We all know that most of our medical expenses occur at the end of life. This study reported by AuntMinnie showed that stage 4 Medicare cancer patients were being sent for advanced imaging studies more frequently than those with earlier stages of disease. The conclusion drawn by the investigators was that guidelines have to be developed for the appropriate use of advanced imaging in stage 4 cancer patients. I suspect the Government and other payers will be looking closely at the results of this investigation.

7.26.12 – GAO report on the ACA implementation of “Meaningful Use” show few hospitals and professionals qualify

In case you forgot what it means here’s a working definition for Meaningful Use. From a publication of the Robert Woods Johnson Foundation: Glossary of Health Care Quality Terms, Meaningful use— Meaningful use is a qualification to receive federal funding for health information technology. For instance, if a health information technology (HIT) system is used in a meaningful way to provide better patient care, a health system can qualify to receive federal subsidies to help to pay for the technology.

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