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2011 Potpourri XXXXI

By October 21, 2011Commentary

The Food & Drug Administration and the Centers for Medicare and Medicaid Services have issued a brief notice on the next step in their effort to create a parallel review process which will allow the approval process for marketing of medical products to be conducted at the same time as decisions on whether Medicare will cover the product.  This notice seeks nominations in regard to devices wishing to participate in a pilot program.  The program is to last two years and about five devices a year will be reviewed.  If successful, CMS and FDA intend to extend it to drugs and biologics.  Basically the FDA review will proceed as usual, but CMS will participate and begin its coverage process.  This should provide useful feedback to manufacturers earlier and potentially get beneficial products to patients faster.   (FR Notice)

Reporting of medical errors or near-misses is important to identify potentially sources of patient hazard and opportunities for quality improvement, particularly if the reporting reveals systemic problems.  Many institutions have systems in place, including online systems, for such error reporting.  A Johns Hopkins study looked at whether radiation oncologists and related providers used the system, and if not why not.  About 274 providers responded to the survey.  Almost all reported having been involved in a medical error or near-miss, most of which resulted in no patient harm.  Most said they understood the system and had time to use.  But it often wasn’t used, primarily because of fear of embarrassment, getting colleagues in trouble and creating a liability issue.   (JH Release)

Do we care less about the feelings of people we don’t think are very likable?  Well, yeah, duh.  But that can have some health care ramifications.  Researchers had a group of 40 observers make judgments about the pain of patients who had previously been described to them as having negative, neutral or likable personality traits.  In observing the patients’ description of pain symptoms, as then might be expected, the study participants rated the pain of unlikable patients as not as severe as that of neutral characteristic patients, who in turn had their pain rated lower than that of likable patients.  Since physicians, nurses, and other providers are only human, it is likely they share this approach, which means they need to be sensitive to their view of a patient when managing pain.   (Pain Study)

The Massachusetts Medical Society surveyed its members on health care issues.  Several specialities continue to have severe or critical shortages, including some primary care ones; many doctors are working very long hours and most of them are not happy that a significant portion of those hours are taken up on administrative tasks.  There is difficulty recruiting physicians into the state, even when they trained there, partly because of compensation issues and liability concerns.  Many primary care groups, in fact the majority, are not accepting new patients and report long wait times.  Less than half of the state’s doctors are interested in participating in global payments or ACOs.  In the last five years, however, the number of doctors who are very dissatisfied has declined and the number who are satisfied has risen, so that there about 40% in each group.   (Mass. MD Survey)


Research reported in Archives of Internal Medicine compared three interventions designed to control blood pressure.  There was a control group of usual care and one group that received nurse-administered behavior management, one that got nurse and doctor-based medication management and one that got both of the interventions.  Intervention phone calls were based on home blood pressure readings submitted via a telemonitoring device.  The study had an 18 month period.  The interventions showed positive results at 12 months but not at 18.  However, in a subgroup of those with poor blood pressure at baseline, the combined intervention did show significant results at 18 months.    (Archives Article)

Medicare released the latest results of its Star program for Medicare Advantage and Prescription Drug Plans.  The program collects a variety of quality measures into a summary score of 1 to 5 Stars.  High scoring plans get bonuses and the highest scoring can enroll members all year long.  Only nine of 569 plans received that five score, but that is up from three last year.  Kaiser operated four of the five-star plans.  None of the biggest insurers plans scored that high.  The average score went up to 3.44 from 3.18 last year.  About $4 billion in bonuses will be paid out, which compensates to some extent for the cuts to Medicare Advantage payments enacted in the “reform” law.  The plans are focused on improving their scores, which may or may not be a good thing, as they may neglect other areas which are even more important to better health outcomes.   (CMS Data)


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