{"id":28032,"date":"2012-04-05T10:09:48","date_gmt":"2012-04-05T14:09:48","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=voices&p=28032"},"modified":"2012-04-05T10:09:48","modified_gmt":"2012-04-05T14:09:48","slug":"when-the-feds-come-knocking","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/04\/05\/when-the-feds-come-knocking\/","title":{"rendered":"When the Feds Come Knocking"},"content":{"rendered":"

CardioExchange welcomes this guest post from electrophysiologists Westby Fisher and John Mandrola. This piece originally appeared on their respective blogs, Dr. Wes<\/a> and Dr. John M<\/a>.<\/em><\/p>\n

Slightly over a year ago, the Department of Justice (DOJ) launched an investigation of a large number of institutions regarding concerns that implantable cardiac defibrillator (ICD) procedures were performed for reasons outside of the criteria set forth in Medicare\u2019s National Coverage Decision (NCD). This investigation occurred just after Al-Khatib and others\u00a0published<\/a>\u00a0a JAMA<\/em> report on January\u00a04, 2011 that suggested as many as 22.5% of implantable defibrillators\u00a0implanted for primary prevention of sudden death were not evidence-based. While the physician community\u00a0took issue<\/a>\u00a0with the Al-Khatib paper, the media firestorm it generated \u2014 paired with the\u00a0announcement<\/a>\u00a0to the Heart Rhythm Society physician community\u00a0that a federal investigation was underway\u00a0\u2014 had a\u00a0chilling effect on ICD implantation nationwide. Drs. Jonathan S. Steinberg and Suneet Mittal have published a report<\/a>\u00a0on their experience\u00a0with DOJ investigators under this heavy regulatory oversight in the Journal of the American College of Cardiology<\/em>.<\/p>\n

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Steinberg and Mittal’s diplomatic account carefully describes the challenges of retrospective audits performed by DOJ lawyers and those of their targeted health care facilities.\u00a0The DOJ identified 229 cases as potentially inappropriate based on Medicare-code criteria. (This represented 8.7% of the de novo non-resynchronization ICD implants done\u00a0for primary prevention at their institutions).\u00a0After determining that some\u00a0of these targeted cases\u00a0were actually for secondary prevention or other coding transgressions, the authors could medically justify all but thirty-four (15% \u2014 or a very low 1.5%\u00a0of all ICDs<\/em>\u00a0implanted for primary prevention of sudden death) at their institution. As has been the case in most reports, the majority of outside NCD-directed ICD implants occurred because of timing violations \u2014 too close to the diagnosis of heart failure, heart attack, and coronary intervention.\u00a0These timing constraints constitute the primary issue before implanting doctors: their professional society guidelines do not \u2014 in all cases \u2014 recognize similar timing restrictions.<\/p>\n

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It is surprising that we are not told what sanctions, if any, were levied against their respective institutions. Perhaps the authors felt this important detail was unimportant to disclose or perhaps they were prohibited from doing so. Perhaps their penalty is still being determined: after all, nothing drives behavior like fear. To this end, we found the authors\u2019 compliments of the government\u2019s legal team unusual to report in a scientific manuscript, as if they were suffering from Stockholm Syndrome<\/a>. We should acknowledge that the authors have added much-needed clarity to the gray area of decision-making surrounding ICD implantation. Their explanations of timing violations highlight problems with coding and confusion around incidental PCI intervention in patients with dilated cardiomyopathy, and demonstrate the overlap decisions that must be made when bradycardia and tachycardia functions might be required for our patients. This kind of clinically relevant nuance was lacking in the impugnable Al-Khatib JAMA<\/em> piece.<\/p>\n<\/div>\n

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We\u00a0can only speculate about the large cost of the legal fees and man-hours devoted to this review process. We will never know how many patients died during, and after, the course of this investigation because they were not offered ICDs (because ICDs can only be offered to patients who meet\u00a0Medicare\u2019s rigid, outdated, and still-to-be-updated NCD for implantable defibrillators). But perhaps this is the price of regulation that\u00a0America\u00a0is willing to pay in return for cost savings. Perhaps we should not be concerned\u00a0that professional guidelines for care delivery should be second fiddle to government mandates for ICD implantation.<\/p>\n

With this latest report, a new era for medical practice is now upon us \u2013 one where priorities of low-cost care and high quantity of care determined by non-medical personnel supersede the highest quality of medical care to our patients. For regulators, it is easy to be a Monday-morning armchair quarterback evaluating\u00a0health care delivery. It is far harder, however,\u00a0to decide prospectively who is likely to die (or not) when they sit before you with a newly-diagnosed cardiomyopathy and ejection fraction of 12%.<\/p>\n

When government and legal officials who carry no responsibility for the long-term well-being of our patients have the authority to retrospectively impugn and penalize doctors (and their health care facilities) based merely on retrospective reviews of billing codes and outdated\u00a0payment mandates, they risk irrevocable harm to patients who might qualify for devices according to updated professional guidelines. Doctors everywhere should stand up collectively to disown\u00a0the practice of using NCD mandates, rather than updated professional guidelines,\u00a0to determine appropriate care for patients.<\/p>\n

After all, our patients are depending on us.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

CardioExchange welcomes this guest post from electrophysiologists Westby Fisher and John Mandrola. This piece originally appeared on their respective blogs, Dr. Wes and Dr. John M. Slightly over a year ago, the Department of Justice (DOJ) launched an investigation of a large number of institutions regarding concerns that implantable cardiac defibrillator (ICD) procedures were performed […]<\/p>\n","protected":false},"author":1177,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[1198,448],"class_list":["post-28032","post","type-post","status-publish","format-standard","hentry","category-electrophysiology","tag-federal-audit","tag-icds"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/28032","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/1177"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=28032"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/28032\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=28032"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=28032"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=28032"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}