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2012 Potpourri VIII

By March 2, 2012March 3rd, 2012Commentary

Device regulation in the United States has endured critical review in recent years and significant changes are proposed.  Devices have become both more complex and more commonplace as a treatment modality.  An article in the New England Journal of Medicine examines regulation in the United States and Europe.  Both systems have challenges.  The FDA has been criticized for being slow and for creating expensive approval mechanisms, but at the same time for allowing potentially high-risk devices to get clearance through an inappropriately low-risk pathway.  Europe relies on private entities to evaluate devices and has limited transparency to process and data and limited coordination across countries in terms of after-market monitoring.  In general, the authors seem to feel that the US system provides greater safety to patients, even though valuable technologies may be slower to be approved and therefore available to patients.   (NEJM Perspective)

An article in Health Affairs reports that many physicians are careful in their conversations with patients.  Based on a survey of almost 1900 doctors, it suggests that while most physicians agree that it is important to fully inform patients about the benefits and risks of various treatments, about one-third did not completely agree with disclosing serious medical errors to patients, about one-fifth did not agree that a physician should never tell a patient something that was untrue, about two-fifths did not agree that they should disclose all their relationships with drug or device companies and one-tenth said they had told patients something untrue in the last year.   (HA Article)

The Office of Inspector General looked at CMS’ oversight of home health care agencies.  OIG focused on the Outcome and Assessment Information Set data and found that for about 6% of claims the information was not submitted, but CMS only penalized a fraction of the offenders.  In addition, OIG found that about 15% of OASIS datasets were submitted late.  States have some responsibility to oversee home health care agencies and OIG also reported that states did a limited job of monitoring reporting and performance and that CMS did a limited job of checking on how the states were doing.  OIG recommended that CMS identify and penalize all missing and late OASIS data reporting and step-up its oversight of states’ oversight of home health agencies.    (OIG Report)

The Annals of Emergency Medicine published an analysis of a CMS rule regarding use of CT scans in emergency rooms.  The rule relates to scanning for patients with non-traumatic headache.  The researchers looked at 748 patients who CMS said had inappropriate scans, based on use of billing records, and found that in fact, when medical records were examined, 65% of the scans complied with the CMS measure and another 18% were valid based on guidelines and expert consensus.  So CMS’ measure only accurately picked up inappropriate scans 16% of the time.  Just shows the danger of relying on administrative data for clinical measures.   (Annals Release)

The current issue of the New England Journal of Medicine has several commentaries on patient-centered care.  Such care is supposed to be focused on consistency with patient goals and values.  Instead of process of care or even health outcome measures like mortality, such care would be measured by management of symptoms that are important to the patient and improvement in functional items that the patient wants improved.  Another commentary focuses on shared decision-making as critical to involving and being responsive to patients, but of course the big obstacle there is that many patients, especially with serious diseases, are not capable of being that involved.  Another issue is that if we expect physicians to help control costs by reducing inappropriate use of medical resources, that may not be consistent with patient wishes when the patient wants all kinds of treatment that probably won’t be helpful.   (NEJM Perspective) 

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