healthy4u: Kathleen Sebelius

Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning. Press reports say she is resigning in large part due to the Exchange Website debacle.   This from the New York Times: <blockquote class="tr_bq">Health Secretary Resigns After Woes of HealthCare.gov <a href="http://www.nytimes.com/2014/04/11/us/politics/sebelius-resigning-as-health-secretary.html?_r=0" target="_blank">http://www.nytimes.com/2014/04/11/us/politics/sebelius-resigning-as-health-secretary.html?_r=0</a> ... Officials said Ms. Sebelius, 65, made the decision to resign and was not forced out [Yeah, right - SS]. But the frustration at the White House over her performance had become increasingly clear, as administration aides worried that the crippling problems at HealthCare.gov, the website set up to enroll Americans in insurance exchanges, would result in lasting damage to the president’s legacy.</blockquote> It's not as if there's no literature out there on how to create good health IT.  Doing so is not a state secret.  Simple (and free, unlike the hundreds of millions spent on incompetent <a href="http://en.wikipedia.org/wiki/Beltway_bandits">beltway-bandit</a> 'consultants') Google searches on the term <a href="https://www.google.com/search?q=%22healthcare+IT+failure%22">"healthcare IT failure"</a> or similar return ample resources that could have prevented the "lasting damage to the president's legacy." Way to go, Ms. Ex-Secretary.  Another health IT amateur bites the dust, as my early computer mentor, Philadelphia's George Washington High School math instructor Fred Holzwarth (<a href="http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf">http://www.historicbuckscounty.org/nths/HISTORIA/PDF/Historia_Nov2005.pdf</a>) would have said. However, even worse ... far worse ... Under this Secretary of the Department of Health and Human Services, the principal watchdog agency over medicine and medical device safety under her aegis, the FDA, found that: <blockquote class="tr_bq">... products with health management heath IT functions, includes software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software. Products with health management health IT functions are of sufficiently low risk and thus, if they meet the statutory definition of a medical device, FDA does not intend to focus its oversight on them. </blockquote> <div style="margin-bottom: 0in;">Thus, patients are condemned to injury and death, probably at ECRI Deep Dive study levels [1], for the foreseeable future (see my post on that FDA decision at my April 9, 2014 post <a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html"> <style type="text/css">P { margin-bottom: 0.08in; }</style></a>"FDA on health IT risk: reckless, or another GM-like political coverup?" at <a href="http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html">http://hcrenewal.blogspot.com/2014/04/fda-on-health-it-risk-reckless-or.html</a>).</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">This is especially outrageous at the time massive investigations are ongoing about the 13 deaths caused by apparent coverups of a faulty General Motors ignition switch.</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">It was your FDA agency, Ms. Ex-Secretary.  You own that decision.</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">Good Riddance, indeed.  </div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">The person at this link: <a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html</a> would certainly agree, if she were alive; she is not thanks to the very devices your FDA just perversely found to be of "sufficiently low risk."</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">-- SS</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">Note:</div><div style="margin-bottom: 0in;"> </div><div style="margin-bottom: 0in;">[1]  In 9 weeks in 36 PSO-member hospitals, 171 IT mishaps sufficient to cause harm were voluntarily reported; 8 injuries occurred, some severe, and 3 deaths may have been the result.  See <a href="http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html">http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html</a>.</div>

Healthcare IT Amateur Kathleen Sebelius Resigns - Good Riddance

The Secretary of the U.S. Department of Health and Human Services (HHS) is resigning. Press reports say she is resigning in large part due t...

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Cybernetik Über Alles Again: HHS and Sebelius - Hospitals And Their Computers Have More Rights Than Patients

A Nov. 29, 2012 New York Times article by Reed Abelson entitled "<a href="http://www.nytimes.com/2012/11/29/business/medicare-is-faulted-in-electronic-medical-records-conversion.html" target="_blank">Medicare Is Faulted on Shift to Electronic Records</a>" observes that: <blockquote class="tr_bq">The conversion to electronic medical records — a critical piece of the Obama administration’s plan for health care reform — is “vulnerable” to fraud and abuse because of the failure of Medicare officials to develop appropriate safeguards, according to a sharply critical report to be issued Thursday by federal investigators [the report from HHS OIG is <a href="https://oig.hhs.gov/oei/reports/oei-05-11-00250.pdf" target="_blank">here</a> - ed.] ... Medicare, which is charged with managing the incentive program that encourages the adoption of electronic records, has failed to put in place adequate safeguards to ensure that information being provided by hospitals and doctors about their electronic records systems is accurate. To qualify for the incentive payments, doctors and hospitals must demonstrate that the systems lead to better patient care, meeting a so-called meaningful use standard by, for example, checking for harmful drug interactions. [I note that meeting EHR "meaningful use" standards does not necessarily signify better care; the "standards" are experimental - ed.]</blockquote> Hospitals and doctors are lying about their EHR efforts, in order to gain incentive payments, it seems. In an article "<a href="http://www.publicintegrity.org/2012/11/29/11865/medicare-paid-36-billion-electronic-health-records-didnt-verify-quality-goals-were" target="_blank">IG says program is 'vulnerable' to abuse, better oversight needed</a>", Fred Schulte at the Center for Public Integrity notes: <blockquote class="tr_bq">... the Centers for Medicare and Medicaid Services has since paid out more than $3.6 billion to medical professionals who made the switch without verifying they are meeting the required quality goals, according to a new federal <a href="https://oig.hhs.gov/oei/reports/oei-05-11-00250.pdf">audit</a> to be released today </blockquote> Observes the CEO of the American Health Information Management Association: <blockquote class="tr_bq"> “We’ve gone from the horse and buggy to the Model T, and we don’t know the rules of the road. Now we’ve had a big car pileup,” said Lynne Thomas Gordon, the chief executive of the American Health Information Management Association, a trade group in Chicago.  </blockquote> More Horse and Buggy than Model T.  At least the Model T was reasonably dependable.  Also mentioned is this: <blockquote class="tr_bq"><div itemprop="articleBody">House Republicans echoed these concerns in early October <a href="http://waysandmeans.house.gov/uploadedfiles/hhs_ehr_mu2_final.pdf" title="The letter to Ms. Sebelius.">in a letter</a> to Kathleen Sebelius, secretary of health and human services. Citing the Times article, they called for suspending the incentive program until concerns about standardization had been resolved. “The top House policy makers on health care are concerned that H.H.S. is squandering taxpayer dollars by asking little of providers in return for incentive payments,” said a statement issued at the same time by the Republicans, who are likely to seize on the latest inspector general report as further evidence of lax oversight. Republicans have said they will continue to monitor the program.</div><div itemprop="articleBody"> </div>In her letter in response, which has not been made public, Ms. Sebelius dismissed the idea of suspending the incentive program, arguing that it “would be profoundly unfair to the hospitals and eligible professionals that have invested billions of dollars and devoted countless hours of work to purchase and install systems and educate staff.”</blockquote> I was taught "first, do no harm."  Fairness to patients injured and killed by this technology in its present "Horse and Buggy" state (<a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/" target="_blank">buggy</a> being a particularly apropos term) seems not a matter of particularly high concern to HHS.   A suspension of incentives would slow the adoption rate down, necessary in order to "get the bugs" out of the technology before mass deployment and develop safety, validation and surveillance standards (currently non-existent), as I wrote in my Oct. 24, 2012 "<a href="http://hcrenewal.blogspot.com/2012/10/letter-to-us-senators-and.html" target="_blank">Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems</a>." This is despite the fact that FDA, IOM and others have indicated the level of harm is not known, due to systematic impediments to diffusion of that knowledge (see IOM statements in the midsection of my post on health information technology hyper-enthusiasm <a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">at this link</a>, and an internal FDA memo on HIT safety <a href="http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html" target="_blank">at this link</a>).  HHS seems to care not about health and human services, or at best to be severely misguided.  "<a href="http://hcrenewal.blogspot.com/2011/10/cybernetik-uber-alles-computers-have.html" target="_blank">Cybernetik Über Alles</a>" seems their current credo. -- SS

Cybernetik Über Alles Again: HHS and Sebelius - Hospitals And Their Computers Have More Rights Than Patients

A Nov. 29, 2012 New York Times article by Reed Abelson entitled " Medicare Is Faulted on Shift to Electronic Records " observes th...

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Congresswoman Renee Ellmers on Health IT Concerns

A letter on Health IT from Congresswoman <a href="http://ellmers.house.gov/index.cfm?sectionid=94&sectiontree=2,94">Renee Ellmers</a>, (R) NC, Chairwoman of the U.S. House of Representative's Committee on Small Business, Subcommittee on Healthcare and Technology was just sent to Secretary of the Dept. of Health and Human Services Kathleen Sebelius. The themes in the letter will be familiar to readers of Healthcare Renewal. A PDF copy of the letter can be downloaded by clicking below, and the text follows. <div style="text-align: center;"><a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh_2qirVMyivJO381vV0HLJ5llEXSAZTVTTq38vhgR-RkUBW0XIKs_CJQR43Sxm1tjdVyB8YkT_9FcRqSwIU02xHFgfYVe4TnyG4852AOTTRfq0U1PbZEmb8qgX06yZPn2b4IDfipISDnDD/s1600/ellmers.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5639969911782066050" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEh_2qirVMyivJO381vV0HLJ5llEXSAZTVTTq38vhgR-RkUBW0XIKs_CJQR43Sxm1tjdVyB8YkT_9FcRqSwIU02xHFgfYVe4TnyG4852AOTTRfq0U1PbZEmb8qgX06yZPn2b4IDfipISDnDD/s320/ellmers.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 246px; height: 320px;" /></a>(<a style="font-weight: bold;" href="http://smbiz.house.gov/UploadedFiles/Health_IT_Concerns_Sebelius_8.11.11.pdf">click here</a> to download PDF) </div> Here is the text, along with several comments: <blockquote> August 11, 2011 The Honorable Kathleen Sebelius Secretary U.S. Department of Health and Human Services 200 lndependence Avenue, S.W. Washington, DC 20201 Via Facsimile: 202. 690.7380 Dear Secretary Sebelius: The House Small Business Committee, on which I serve, is required by the Rules of the House to study and investigate the problems of all types of small businesses. This jurisdiction extends to matters concerning small businesses and health care. I chair the Committee’s Subcommittee on Healthcare and Technology. On June 2, 2011, the Subcommittee held a hearing on the barriers to health information technology that are encountered by physicians and other providers in small practices. At the hearing, physicians testified that the cost to purchase and maintain a health IT system, is addition to staff training and downtime during the transition to health IT, are significant burdens for small practices. These barriers mere mentioned even by physicians who believe health IT would ultimately benefit their practices. Providers at the hearing also stated their concern about the Medicare reimbursement penalties that will be assessed against providers who do not demonstrate “meaningful use” of health IT by 2015. One of the frequently mentioned benefits of health IT has been a reduction in medical errors. However, recent news reports have noted incidents of health IT errors. An article in Sunday’s Pittsburgh Post-Gazette [a series, actually, <a style="font-weight: bold; font-style: italic;" href="http://hcrenewal.blogspot.com/2011/05/healthcare-renewal-cited-in-pittsburgh.html">here</a> and <a style="font-weight: bold; font-style: italic;" href="http://www.post-gazette.com/pg/11219/1165767-114-0.stm?cmpid=nationworld.xml">here</a>- ed.] cited a baby who was killed while computerized IV equipment prepared a lethal dose of an intravenous sodium chloride solution. The machine did not catch the pharmacy technician’s error. The article also noted that when a hepatitis C-positive kidney was accidentally transplanted from a live donor into a recipient, the physician team missed the electronic records alert, and the physicians complained that their electronic records system is cumbersome and difficult to adjust to any one physician’s needs. [You can be sure that my writings on health IT mission hostility, poor quality, lack of regulation, etc. as well as the cases of health IT-related injury and death I know of, including that of my own relative, will find their way to Rep. Ellmer's office - ed.] The Journal of the American Medical Association recently published a study of almost 4,000 computer-generated prescriptions that were received by a pharmacy chain. The report found that 12 percent of the prescriptions contained errors, which, the report said, is consistent with error rates with handwritten prescriptions. [I wrote about that <a style="font-weight: bold; font-style: italic;" href="http://hcrenewal.blogspot.com/2011/06/electronic-medication-prescribing-magic.html">here</a> - ed.] A modern, well-equipped office is critical to the practice of medicine, and health IT offers promise to all medical professionals. [But only when done well - and there is massive complexity behind those simple two words "done well" that is poorly recognized and/or ignored - ed.] Health IT has the potential to improve health care delivery, decrease medical errors, increase clinical and administration efficiency, and reduce paperwork. We most do all we can to ensure a commitment to our health care system and patient care. As technology rapidly evolves, I ask that you consider a study of health IT’s adoption, benefits and cost effectiveness. [Cart before the horse when being done AFTER a national multi-billion dollar rollout is put into law, <a href="http://hcrenewal.blogspot.com/2010/10/cart-before-horse-again-institute-of.html">as I wrote here</a>, but better late than never - ed.] As part of the study, I hope you will also consider medical error rates — both human and technological --so that all errors can he better assessed and prevented. [I have been calling for this for years now - ed.] Sincerely, Renee Ellmers Chairwoman Subcommittee on Healthcare and Technology House Committee on Small Business </blockquote> I find this letter from a leading member of the House of Representatives remarkable. Importantly, Chairwoman Ellmers has a medical background (HHS Secretary Sebelius, to my knowledge, does not). Here is part of Chairwoman Ellmer's <a href="http://en.wikipedia.org/wiki/Renee_Ellmers">background</a> from Wikipedia: <blockquote>In 1990, she graduated with a Bachelor of Science degree in Nursing. Ellmers worked as a nurse in Beaumont Hospital's surgical intensive care unit. In North Carolina, she was clinical director of the Trinity Wound Care Center in Dunn.</blockquote> The only other letters like it asking questions like this that I know of came from a Republican Senator to the HIT vendors, Sen. Grassley of Iowa (see <a href="http://hcrenewal.blogspot.com/2009/10/washington-post-emrs-no-cure-all-sen.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/01/grassley-asks-hospitals-about.html">here</a>). Sen. Grassley also wrote directly on HIT problems to HHS Secretry Sebelius on Feb. 24, 2010; see the letter <a href="http://www.scribd.com/doc/27483558/Grassley-Feb-24-Letters">here</a>. -- SS

Congresswoman Renee Ellmers on Health IT Concerns

A letter on Health IT from Congresswoman Renee Ellmers , (R) NC, Chairwoman of the U.S. House of Representative's Committee on Small Bus...

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