healthy4u

BLOGSCAN: Key Opinion Leader Admits to being a Marketer

Without any notable shame, and <a href="http://www.kevinmd.com/blog/2012/08/doctors-key-opinion-leader-social-media.html">as a guest blogger</a> on KevinMd.  The post was about other physicians can become big-time KOLs by using social media, and refers to <a href="http://www.medcrunch.net/pharma-marketing-101-two-things-pharma-needs-from-you/">another post</a> which indicates that pharmaceutical companies look for physicians who are big prescribers of their products and have a lot of influence to, guess what, help market their products.  Although the blogger refers to ethics more than once, how it is ethical to trade on the trust physicians get for their professional vows to put patients first to market products (that may not always be good for patients) remains beyond me. ADDENDUM (27 August, 2012) - See also <a href="http://brodyhooked.blogspot.com/2012/08/you-too-can-be-kol.html">comments</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

BLOGSCAN: Key Opinion Leader Admits to being a Marketer

Without any notable shame, and as a guest blogger on KevinMd. The post was about other physicians can become big-time KOLs by using social...

Đọc thêm »

An Even Bigger Golden Parachute for Captain Outrageous

In 2009, I first <a href="http://hcrenewal.blogspot.com/2009/09/captains-outrageous-for-cape-annes.html">posted</a> about the amazingly colorful leadership and governance problems at a small hospital system in Massachusetts.  Background: Northeast Health System The story of Northeast Health System then included  leaders who solicited money from the community but concealed what they were doing from the same community, an adolescent pregnancy pact after the hospital system refused to provide confidential birth control information at the high school clinic it ran, a hospital vice-president accused of art theft, various cuts, some concealed, of medical services, accusations of conflicts of interest affecting the board of trustees, and no-confidence votes by nurses and physicians. Finally, Stephen Laverty, the CEO held responsible for much of the mess, resigned and things quieted down a bit.  However, he left a system in deficit, leading to further lay-offs, (e.g., see <a href="http://www.boston.com/yourtown/salem/articles/2010/08/18/beverly_hospital_group_to_cut_jobs/">this story</a> in the Boston Globe).  And the vice-president accused of art theft was also "arraigned on bribery and larceny charges" (also <a href="http://www.boston.com/business/healthcare/articles/2010/07/23/former_hospital_official_accused_of_kickback_scheme">per the Boston Globe</a>.) Nonetheless, in 2010, it was <a href="http://hcrenewal.blogspot.com/2010/09/golden-parachute-for-captain-outrageous.html">revealed</a> that Mr Laverty left with a golden parachute worth more than $1 million.  But wait, now there is more. A Guilty Plea In May, 2012, <a href="http://www.salemnews.com/local/x1221403196/Former-hospital-VP-gets-18-months-in-jail">per the Salem News</a>, <blockquote>A former associate vice president at Beverly Hospital pleaded guilty yesterday to soliciting bribes and kickbacks from hospital contractors and stealing valuable paintings and other antiques while overseeing a $50 million renovation of the facility. Paul Galzerano, 60, was sentenced to serve 18 months of a two-year jail term on four larceny counts and two years of probation on two counts of commercial bribery during a hearing yesterday at Salem Superior Court.</blockquote> Yet More Severance Payments But wait, there is even more. Yesterday, the Gloucester Times <a href="http://www.gloucestertimes.com/local/x1088167079/Ex-hospital-CEO-Laverty-cashing-in">reported</a> about Mr Galzerano's former boss, <blockquote>Nearly four years after he resigned under fire, former Northeast Health System CEO Stephen Laverty is still collecting big paychecks from his former employer. Laverty was paid $573,348 in severance in 2011, the second year in a row he has received buyout money from Northeast, the parent nonprofit corporation to Beverly Hospital and Gloucester’s Addison Gilbert Hospital, and a corporation that was essentially merged with Lahey Clinic to become the new Lahey Health System under an agreement that gained the necessary state approvals earlier this year. </blockquote> Laverty's total severance payments have reached "more than $1.56 million over those two years." Whether the payments have ended is not clear. Attempts to discover why payments continued and became so large revealed only, <blockquote>Beverly Hospital released a statement Monday saying, 'We cannot comment on Mr. Laverty or the terms of any agreements between the company and past employees.'</blockquote>Summary For a relatively small hospital system, Northeast Health System has produced an enormous example of the perverse incentives given to top executives of health care organizations. Mr Laverty has been made a millionaire despite what the Gloucester Times called in its news article a "tenure plagued by acrimony and controversy," and leadership previously described in a Gloucester Times editorial as "arrogant, dictatorial," and a history of what only can be described as outrageous management failures. Furthermore, the money he received came not from rich stockholders, but from a struggling community hospital system. The ability of top executives of many, probably most health care organizations to collect bloated paychecks out of proportion to, if not despite their performance attracts the wrong people to lead these organizations, and provides incentives for even the right people to lead badly.  Until we make health care leaders accountable, and until their incentives reflect their ability to uphold the health care mission, expect more unaccountable leadership that subverts the health care mission, and hence continually rising costs, declining access, and deteriorating quality.

An Even Bigger Golden Parachute for Captain Outrageous

In 2009, I first posted about the amazingly colorful leadership and governance problems at a small hospital system in Massachusetts. Backg...

Đọc thêm »

Pfizer's Pforeign Pfiasco

Quelle surprise.  Giant international pharmaceutical company Pfizer managed to go for nearly 10 months without announcing a major legal settlement.  However, this month, as <a href="http://www.bloomberg.com/news/2012-08-07/pfizer-agrees-to-settle-foreign-bribery-case-with-u-s-.html">reported</a> by Bloomberg, it was time for Pfizer to settle again.  The basics were: <blockquote>Pfizer Inc., the world’s biggest drugmaker, agreed to pay $60.2 million to settle foreign bribery cases it brought to U.S. authorities involving alleged payments paid by employees and agents of subsidiaries. Pfizer entered into two agreements with the Securities and Exchange Commission and the New York-based drugmaker reached a deferred prosecution accord with the Department of Justice, according to filings today in federal court in Washington. </blockquote> Bribery This case is worth perusing because of how it documents what the US government called not merely deceptive, but corrupt practices used by Pfizer to sell drugs. The practices were widespread around the world: <blockquote>The settlements announced today include Pfizer operations in eight countries: Bulgaria, Croatia, Kazakhstan, Russia, Italy, China, the Czech Republic and Serbia. The Wyeth settlement, over its nutrition business, was for China, Indonesia, Saudi Arabia and Pakistan. </blockquote> The practices involved, not to put too fine a point on it, bribing doctors. Furthermore, as part of the settlement Pfizer apparently admitted to some of the specific practices alleged by the government: <blockquote>In Bulgaria, local representatives spent $28,000 to invite government doctors on 'incentive trips' to Greece, as a reward for the physicians who were the biggest prescribers of Pfizer’s products, Pfizer admitted according to the Justice Department filing. They also paid $17,000 to send doctors to medical conferences, again in exchange for commitments to prescribe Pfizer drugs. In Croatia, the unit there had used a consulting agreement with a government doctor to help influence which drugs were allowed to be sold in the country, paying the physician in cash and travel expenses, Pfizer admitted. Pfizer also admitted to what was called the 'hospital program,' in Russia, where doctors were given a 5 percent kick- back on certain drugs prescribed. 'Pfizer Russia used the Hospital Program to make cash payments to individual government healthcare professionals to corruptly reward past purchases and prescriptions of Pfizer products, and to corruptly induce future purchases and prescriptions,' the Justice Department said in the filing. Pfizer’s Russian unit also used intermediary companies to pay off doctors and government officials, the company admitted. </blockquote> No Individual Penalties Despite the shamefulness of these practices, as is now distressingly usual (look <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">here</a>), no individual seems to be obligated to suffer any penalty or negative consequences as a result of this settlement. While the US government alleged criminal behavior, beyond the fines imposed on the company, further prosecution will be deferred: <blockquote>The Justice Department charged the Pfizer HCP Corp. unit with two criminal counts, conspiracy to violate the Foreign Corrupt Practices Act and a violation of the FCPA’s anti-bribery provisions. Prosecutors agreed to defer prosecution and drop the charges after two years if Pfizer continues to cooperate and take remedial steps. </blockquote> The article contained a curious statement seemingly asserting that the payments were somehow made independent of any actions by individuals at Pfizer: <blockquote>The SEC said the payoffs were made 'without the knowledge or approval of officers or employees of Pfizer, but the inaccurate books and records of Pfizer subsidiaries were consolidated in the financial reports of Pfizer.' </blockquote> So were the payments made by machines acting autonomously? or by ghosts? Maybe this was just a typo. However, note that the de rigeur statement by Pfizer's internal counsel was phrased so as to imply the actions somehow occurred outside of the organization: <blockquote>'The actions which led to this resolution were disappointing, but the openness and speed with which Pfizer voluntarily disclosed and addressed them reflects our true culture and the real value we place on integrity and meeting commitments,' Amy Schulman, Pfizer’s general counsel, said in an e-mailed statement.</blockquote> Summary This latest settlement reaffirms the poor ethical culture now prevalent in major health care organizations throughout the world.  It also affirms how deeply unethical the culture has become at some of our largest and most prominent and influential health care organizations.  This settlement is only the latest evidence of ethical missteps by Pfizer's leadership. In the beginning of the 21st century, <a href="http://articles.philly.com/2009-09-03/business/25267571_1_pfizer-employee-pfizer-sales-representatives-zyvox">according to the Philadelphia Inquirer</a>, Pfizer made three major settlements, <blockquote>October 2002: Pfizer and subsidiaries Warner-Lambert and Parke-Davis agreed to pay $49 million to settle allegations that the company fraudulently avoided paying fully rebates owed to the state and federal governments under the national Medicaid Rebate program for the cholesterol-lowering drug Lipitor. May 2004: Pfizer agreed to pay $430 million to settle DOJ claims involving the off-label promotion of the epilepsy drug Neurontin by subsidiary Warner-Lambert. The promotions included flying doctors to lavish resorts and paying them hefty speakers' fees to tout the drug. The company said the activity took place years before it bought Warner-Lambert in 2000. April 2007: Pfizer agreed to pay $34.7 million in fines to settle Department of Justice allegations that it improperly promoted the human growth hormone product Genotropin. The drugmaker's Pharmacia & Upjohn Co. subsidiary pleaded guilty to offering a kickback to a pharmacy-benefits manager to sell more of the drug.</blockquote> Thereafter, Pfizer paid a $2.3 billion settlement in 2009 of civil and criminal allegations and a Pfizer subsidiary entered a guilty plea to charges it violated federal law regarding its marketing of Bextra (see post <a href="http://hcrenewal.blogspot.com/2009/09/pfour-legal-settlements-for-pfizer-why.html">here</a>).  Pfizer was involved in two other major cases from then to early 2010, including one in which a jury found the company guilty of violating the RICO (racketeer-influenced corrupt organization) statute (see post <a href="http://hcrenewal.blogspot.com/2010/03/settlement-and-conviction-round-up.html">here</a>).  The company was listed as one of the pharmaceutical "big four" companies in terms of defrauding the government (see post <a href="http://hcrenewal.blogspot.com/2010/12/drug-companies-are-now-no-1-when-it.html">here</a>).  Pfizer's Pharmacia subsidiary settled allegations that it inflated drugs costs paid by New York in early 2011 (see post <a href="http://hcrenewal.blogspot.com/2011/02/pharmacia-or-maybe-pfizer-settles-only.html">here</a>).   In March, 2011, a settlement was announced in a long-running class action case which involved allegations that another Pfizer subsidiary had exposed many people to asbestos (see <a href="http://www.bloomberg.com/news/2011-03-22/pfizer-reaches-asbestos-settlement-that-may-end-quigley-unit-s-bankruptcy.html">this story</a> in Bloomberg).  In October, 2011, Pfizer settled allegations that it illegally marketed bladder control drug Detrol (see this <a href="http://hcrenewal.blogspot.com/2011/10/what-pfizer-v-few-consequences-for-long.html">post</a>). Thus, it appears on 10 separate occasions between 2002 and 2012, Pfizer settled allegations of, pleaded guilty to, or was convicted for actions that represented seriously unethical behavior.  Note that these included a conviction that found the company to be a racketeer-influenced corrupt organization. Yet the company has not failed or been restructured, and none of its leaders has ever faced any negative consequences.  In fact, last year its CEO made over $18 million, up from over $6 million the year before (see <a href="http://hcrenewal.blogspot.com/2012/04/there-they-go-again-pfizer-ceo.html">this post</a>).    So obviously it is not just that one company's culture has become seriously corrupt.  We seem to live in such a corrupt nation, and maybe such a corrupt global society that such corrupt cultures thrive in our major corporations and organizations.  Despite stories like this in health care, just like in finance despite the global financial collapse, as Charles Ferguson said at the Oscar awards last year, " not a single ... executive has gone to jail, and that's wrong." <iframe allowfullscreen="allowfullscreen" frameborder="0" height="315" src="http://www.youtube.com/embed/mpz5DVwnbnk" width="560"></iframe> Unless we hold leaders of health care organizations accountable for bad behavior and corruption, expect bad behavior and corruption to get worse.  Until we have political leaders with the courage to stand up for honesty and the law, expect continued dishonesty and the law to continue to be trampled by the rich and powerful.

Pfizer's Pforeign Pfiasco

Quelle surprise. Giant international pharmaceutical company Pfizer managed to go for nearly 10 months without announcing a major legal sett...

Đọc thêm »

Did Joint Commission Accredit a Hospital Whose Understanding of Medication Reconciliation is Recklessly Superficial?

I submitted this complaint to the Joint Commission today. I've been challenging them in recent years (especially since my JAMA letter "<a href="http://jama.jamanetwork.com/article.aspx?articleid=184302" target="_blank">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>" on hospital executive's violation of JC Safety Standards of July 2009) over the issue of their accreditation of hospitals using bad health IT. Eventually, I hope, they will take a leadership role on health IT risk, lest they become a target for litigation.  (I think they're already there for their inaction on EHR problems despite admitted knowledge of the problems, in print, e.g., in their 2009 Sentinel Events Alert on Health IT Risks.) Here is my complaint submitted both via email and via the Joint Commission "<a href="http://www.jointcommission.org/report_a_complaint.aspx" target="_blank">Report a Complaint online</a>" page.  I added a few comments for readers in [bold red italics] that, of course, were not part of the submission: ------------------------------ Thank you for submitting your complaint!     Monday, August 20, 2012 Your complaint incident number is:     ########-######## ------------------------------ Dear Joint Commission, <div class="MsoNormal">I also sent this complaint to<a href="mailto:PSchyve@jointcommission.org" target="_blank"></a> PSchyve, AGiuntoli and MChassin via email.</div><div class="MsoNormal"> </div><div class="MsoNormal">You are already aware of the injury and death from Med Recon failure of my mother at [name redacted] Hospital, in an incident that began May 19, 2010.  Reference Incident #######-######.</div><div class="MsoNormal"> </div><div class="MsoNormal">I am also filing the issue below as a formal JC complaint:</div><div class="MsoNormal"> </div><div class="MsoNormal">As demonstrated in the sworn defense response by [name redacted] Hospital today, 8/20/12, the hospital has a very superficial understanding of Med Recon and Med Recon Failure.  </div><div class="MsoNormal"> </div><div class="MsoNormal">I am assuming they passed Joint Commission Accreditation that includes the ability to ensure continuity of care, including giving correct meds via Med Recon.</div><div class="MsoNormal"> </div><div class="MsoNormal">The hospital through defense counsel today (8/20/12) writes in a document I've placed at [URL redacted]:  <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/00235447.pdf" target="_blank"></a></div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal">... 4.  As plead [sic -ed.], the <a href="http://legal-dictionary.thefreedictionary.com/gravamen" target="_blank">gravamen</a> [the basic gist of every claim or charge in a complaint - ed.] of Plaintiffs complaint is the allegation that he told the treating professionals about Mrs. Silverstein's Sotalol medication.</div><div class="MsoNormal"> </div><div class="MsoNormal">5.  Therefore, the central issue of this case is one of human communication- i.e., whether Dr. Silverstein told the various staff or not.  [In other words, their obligations to check medications end there - ed.]</div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">In fact, the complaint was quite clear:</div><div class="MsoNormal"> </div><div class="MsoNormal">...32.  The tortious conduct of defendant [name redacted] Hospital consisted of the following:</div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal">a. vicarious liability for the actions of its agents [redacted], [redacted] and [redacted] to ensure continuation of the Sotalol therapy [can we all agree that's a primary responsibility of a hospital and its agents? - ed.];</div><div class="MsoNormal"> </div><div class="MsoNormal">b. vicarious liability for the actions of its agents [redacted], [redacted] and [redacted] to ensure proper operation of the defendant’s EMR system so as to ensure continuation of a presently active medication;</div><div class="MsoNormal"> </div><div class="MsoNormal">c. vicarious liability for the failure of its agents identified in this complaint to adequately communicate Ms. Silverstein’s complete medication history with the subsequent treating health care providersduring this admission;</div><div class="MsoNormal"> </div><div class="MsoNormal">d. vicarious liability for the failure of its agents, identified in this complaint, to question why no Sotalol was ordered given the noted history of arrhythmia [a medical student-level question - ed.];</div><div class="MsoNormal"> </div><div class="MsoNormal">e. failure to have in place adequate procedures or policies to insure that presently active medications are continuously active in the EMR system unless deactivated by an appropriately qualified health care provider;</div><div class="MsoNormal"> </div><div class="MsoNormal">f. failure to have in place adequate procedures or policies to insure that the computer generates appropriate alerts for others to see when critical medications become inactive;</div><div class="MsoNormal"> </div><div class="MsoNormal">g. failure to properly assess the operational effectiveness of its EMR system so as to insure that presently active medications are automatically continued unless specifically deactivated by a qualified and authorized health care provider.</div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">33. As a result of the above identified failures in medication administration and medical record charting, Ms. Silverstein has suffered the following:</div><div class="MsoNormal"> </div><blockquote class="tr_bq"><div class="MsoNormal">a. Intracranial hemorrhage; b. atrial fibrillation; c. damage to her nerves and nervous system, including memory difficulties, and seizure activity; d. brain compression due to the intracranial hemorrhage; e. requirement for additional procedures; f. prolonged hospitalizations; g. need for rehabilitation; h. need for continuous therapies; i. pain, suffering, embarrassment, humiliation, and the loss of life’s pleasures; j. death. </div></blockquote><div class="MsoNormal"> </div><div class="MsoNormal">While I gave the history of Sotalol to the clinicians on 5/19/10 (my mother had been on it dating to 2002) as I had done multiple times in this ED, this hospital seems to believe its Med Recon responsibilities end at the family - even when they have records in abundance in their paper records and EHRs (ED and floor), including from just a few weeks prior, with current med lists.</div><div class="MsoNormal"> </div><div class="MsoNormal">I note (as I had previously sent you) that Pennsylvania's Medicare QIO, Quality Insights, found the hospital had failed in medication continuity, and that the failure to administer Sotalol caused the recurrent A. fib and subsequent complications, the care not meeting professionally accepted standards. [The formal terminology for "malpractice" - ed.]</div><div class="MsoNormal"> </div><div class="MsoNormal">If you accredited this hospital, as I believe you did, this superficial understanding of Med Recon that you apparently missed or recklessly glossed over poses a serious danger to the community, and contributed materially to my mother's injuries, suffering and death.</div><div class="MsoNormal"> </div><div class="MsoNormal">Sincerely,</div><div class="MsoNormal"> </div><div class="MsoNormal">S. Silverstein, MD</div><div class="MsoNormal"> </div><div class="MsoNormal">Cc:  [attorney handling the malpractice lawsuit]</div><div class="MsoNormal"> </div><div class="MsoNormal">- end complaint -</div><div class="MsoNormal"></div><div class="MsoNormal"> --------------------</div><div class="MsoNormal"> </div><div class="MsoNormal">They defense is also trying to deflect the Judge from the issue of Metadata: <blockquote class="tr_bq">... At this point in time, it is respectfully submitted that the proposed electronic discovery is not relevant to the central issue of this case. For example, if the Triage Nurse and subsequent providers were all to testify that Dr. Silverstein never informed them that Sotalol was a current medication of Mrs, Silverstein, then the fact that medical record does not record this as a current medication has nothing to do with metadata. </blockquote> Wrong. "The fact that medical record does not record Sotalol as a current medication" after the ED encounter on 5/19/10 indicates a forensic examination of the metadata is crucial. It is in fact only through metadata that it can be determined if the medication, listed as "current" only a few weeks prior and normally visible when the user brings up a patient's record to initiate triage, was deleted by the user (e.g., via "use error" per NIST, related to bad IT design) and how and when; if it ended up in another patient's chart due to malfunction (misidentification); if the EHR malfunctioned and simply erased the med; if the chart was altered to try to hide the mistake, etc.  These are all well known failure modes.  See an example of what metadata can show <a href="http://hcrenewal.blogspot.com/2011/09/sweet-death-that-wasnt-very-sweet-how_24.html" target="_blank">at this link</a> in a case that settled for over $1 million before a trial even began. In fact, over and above potentially misrepresenting my and my mother's stated medication history at ED triage: Note their attempting to deflect attention away from health IT and the med recon failure of their own staff.   Also note a reckless understanding of Medication Reconciliation, that seems to imply the hospital believes it had no duty to reconcile meds with itself, that is, check its own EHR or paper records from just a few weeks prior along with multiple others dating back 8 years, or check with the hospital-affiliated primary care and other physicians treating the patient for years, who were reachable via a simple phone call.  Instead, the issue of whether a family member told "them about the med or not" seems to be their central defense.    On the issue of who's actually responsible (and liable) for Med Recon, from the American Medical Association monograph entitled "<a href="http://www.ama-assn.org/resources/doc/cqi/med-rec-monograph.pdf" target="_blank">The physician’s role in medication reconciliation</a>", pg. 3.   <blockquote class="tr_bq">... The essence of medication reconciliation is making sense of a patient’s medications and resolving conflicts between different sources of information [paper, electronic, verbal, information from other physicians treating the patient, etc. - ed.] to minimize harm and to maximize therapeutic effects. It is an ongoing, dynamic, episodic and team-based process that should be led by and is the responsibility of the patient’s attending or personal physician in collaboration with other health care professionals. Medication reconciliation is essential to optimize the safe and effective use of medications. It is one element in the process of therapeutic use of medications and medication management for which physicians are ultimately held legally accountable. </blockquote> The AMA monograph has a special section starting on p. 20 on IT and Med Recon.  It warns explicitly about practicing medicine like a mindless robot: <blockquote class="tr_bq">... IT systems and applications do have the potential to streamline the medication reconciliation process—especially assembling and storing patient information—and to provide the means to effectively transfer patient medication information across the continuum of care. However, health care technology is fragmented and requires close attention by potential users to ensure that implementation does not create additional pressures and problems with accuracy of medications.</blockquote> The apparent hospital misunderstanding of Med Recon could - and in my view, should - result in charges of gross negligence, perhaps criminal, against its medical leadership if other patients have been, or are, harmed as a result of resultant medication reconciliation errors. Of course, it's also possible that the defense is <a href="http://hcrenewal.blogspot.com/2012/08/defense-attorney-lies-under-oath-to.html" target="_blank">just making stuff up again</a> to try to blow smoke up the judge's behind.  However, what's sworn certainly should not be lightly dismissed.  I also note that this hospital is making a spectacle of itself in front of the Judge, the President Judge in the county where it conducts operations, who already dismissed a boatload of meritless claims.  That does not bode well for them in the future. </div><div class="MsoNormal"> </div><div class="MsoNormal">-- SS</div>

Did Joint Commission Accredit a Hospital Whose Understanding of Medication Reconciliation is Recklessly Superficial?

I submitted this complaint to the Joint Commission today. I've been challenging them in recent years (especially since my JAMA letter &q...

Đọc thêm »

Paging Doctor EBDITA - How Private Equity May Push Hospitals to Put Revenue Ahead of Patient Care

Issues raised by the increasing influence of <a href="http://hcrenewal.blogspot.com/search/label/private%20equity">private equity</a> firms in the direct care of patients were illuminated by a series of articles about the for-profit hospital chain HCA. Quality Problems The articles highlighted a series of concerns about quality problems affecting the chain's patients.  Cardiac Overtreatment First, a New York Times <a href="http://www.nytimes.com/2012/08/07/business/hospital-chain-internal-reports-found-dubious-cardiac-work.html">article</a> described problems in the care of cardiac patients.  <blockquote>HCA, the largest for-profit hospital chain in the United States with 163 facilities, had uncovered evidence as far back as 2002 and as recently as late 2010 showing that some cardiologists at several of its hospitals in Florida were unable to justify many of the procedures they were performing. Those hospitals included the Cedars Medical Center in Miami, which the company no longer owns, and the Regional Medical Center Bayonet Point. In some cases, the doctors made misleading statements in medical records that made it appear the procedures were necessary, according to internal reports. </blockquote> More specifically, at one hospital, cardiac catheterizations seemed to occur to often: "about half the procedures ... were determined to have been done to patients without significant heart disease." Two patients at another hospital had severe adverse effects after cardiac procedures that seemed unnecessary in retrospect. There were "incidents at Bayonet Point where patients were treated for multiple lesions, or blockages, even when 'the second lesion (or third) did not appear to have significant disease....' [In] 'several cases'  ... patients were treated even though their arteries did not have significant blockages." Then, <blockquote>HCA brought in an external company, CardioQual Associates of Franklin, Mich., in 2004 to examine medical records from Bayonet Point. In a confidential memo prepared in December 2004 and reviewed by The Times, CardioQual concluded that as many as 43 percent of 355 angioplasty cases, where doctors performed invasive procedures to open up a patient’s arteries, were outside reasonable and expected medical practice. Worse, the investigation revealed that some physicians had indicated in medical records that the patients had blockages of 80 to 90 percent when a later, more scientific analysis of a sampling of cases revealed the blockages had ranged from 33 to 53 percent.</blockquote> Possible Undertreatment of Acute Illness Then, a second NY Times <a href="http://www.nytimes.com/2012/08/15/business/hca-giant-hospital-chain-creates-a-windfall-for-private-equity.html">article</a> found that <blockquote>HCA decided not to treat patients who came in with nonurgent conditions, like a cold or the flu or even a sprained wrist, unless those patients paid in advance. In a recent statement, HCA said that of the six million patients treated in its emergency rooms last year, 80,000, or about 1.3 percent, 'chose to seek alternative care options.'</blockquote> Of course, the problem with this approach is that it is not always possible to tell how severe an acute illness is without a more complete evaluation than can be done in emergency department triage. There is anecdotal evidence that HCA turned away some patients who actually had serious illness: <blockquote>Regulators in several states have taken HCA hospitals to task over screening out patients too aggressively, including situations where the screening missed serious conditions. In early 2010, an uninsured patient who entered HCA’s TriStar Skyline Medical Center in Nashville, complaining of 'pain when breathing,' was sent away. An hour and a half later, at another hospital, the same patient was found to have pneumonia, according to the results of a Medicare investigation. Regulators cited Skyline for having 'failed to ensure that an appropriate medical screening examination was conducted.' This year, the Office of Inspector General fined HCA’s Northside Hospital in St. Petersburg, Fla., $38,000 for sending home a feverish patient with an artificial heart valve. Two days later, the patient reappeared with the flu and severe respiratory problems. The following day, he died. </blockquote> Undertreatment of Bed Sores The second Times <a href="http://www.nytimes.com/2012/08/15/business/hca-giant-hospital-chain-creates-a-windfall-for-private-equity.html">article </a>also suggested that decreased nurse staffing at HCA hospitals lead to worse treatment of bed sores (decubitus ulcers): <blockquote>Experts say there is often a direct correlation between bedsores and the quality of hospital staff levels. 'Staffing is critical,' said Courtney H. Lyder, the dean at the UCLA School of Nursing and an expert on wound care. 'When you see high levels of wounds, you usually see a high level of dysfunctional staff,' he said. HCA owned eight of the 15 worst hospitals for bedsores among 545 profit-making hospitals nationwide, each with more than 1,000 patient discharges, tracked by the Sunlight Foundation using Medicare data from October 2008 to June 2010. HCA’s West Houston Medical Center and CJW Medical Center in Richmond, Va., landed near the top of the list. HCA says it has increased its nursing staff at its hospitals each year over the last five years. But an examination of lawsuits shows bedsore problems have been persistent at several HCA facilities. In Portsmouth Regional Hospital in New Hampshire, a 60-year-old woman died in 2009 after her bedsores went untreated for three days and became infected, according to a wrongful-death lawsuit filed in the spring of 2011 in federal court against the hospital.</blockquote> One HCA hospital <blockquote>was cited twice by Florida regulators, in 2008 and 2010, for having inadequate numbers of nurses on its staff to oversee wound care for patients. During the 2010 examination, regulators noted that Memorial had less than the equivalent of two full-time nurses who specialized in wound care to treat the 132 patients who required aid. 'The system of treatment for wound care places patients at risk for additional medical complications,' the examiners said. </blockquote> So, in summary, there is reason for concern about overtreatment of cardiac disease, and undertreatment of acute illness and bedsores at HCA hospitals. However, no hospital and no doctor is perfect. Everyone makes mistakes, and many decisions can be questioned in retrospect. Instead Putting Money Ahead of Quality Instead, the articles suggested they were part of a pattern in which concerns about short-term revenue trumped concerns about patient care. Cardiac Procedures to Generate More Revenue The <a href="http://www.nytimes.com/2012/08/07/business/hospital-chain-internal-reports-found-dubious-cardiac-work.html">article</a> about cardiac care noted that one of the physicians who allegedly was doing too many cardiac procedures <blockquote>was highlighted by the hospital in a 2009 business plan as being the most profitable doctor at the facility. 'Our leading EBDITA MD,' the plan described him. (Ebitda, or earnings before interest, taxes, depreciation and amortization, is a measure of corporate earnings.) </blockquote> On the other hand, <a href="http://www.tampabay.com/news/health/medicine/scrutiny-of-cardiac-care-at-pasco-hca-hospital-latest-in-long-saga/1244719">according to the Tampa Bay Times</a>, some of the doctors whom HCA suspended for doing too many percutaneous cardiac revascularization procedures charged that the issue was that <blockquote>far from concern over the cost of stents — Bayonet Point was upset that stents were replacing more expensive bypass surgeries.</blockquote> The first NY Times <a href="http://www.nytimes.com/2012/08/07/business/hospital-chain-internal-reports-found-dubious-cardiac-work.html">article</a> also suggested that HCA executives did their best to keep the issue quiet so as not to affect revenue. First, <blockquote>HCA declined to provide evidence that it had alerted Medicare, state Medicaid or private insurers of its findings, or reimbursed them for any of the procedures that the company later deemed unnecessary, as required by law. </blockquote> Also, <blockquote>HCA also declined to show that it had ever notified patients, who might have been entitled to compensation from the hospital for any harm. </blockquote> The Times uncovered internal HCA communications suggesting that obfuscation was deliberate: <blockquote>In January 2005, David Williams, who was then the chief executive of Bayonet Point, wrote in an e-mail: 'Clearly, we have protected ourselves under the peer review umbrella and have released very little information.' The recipients of his message included Dan Miller, who then oversaw HCA’s hospitals in western Florida, and Charles R. Evans, a Nashville executive who was president of all of HCA’s hospitals on the eastern side of the country. In his response, Mr. Evans thanked Mr. Williams for the update and asked for a 'summary as to the business impact.' </blockquote> Furthermore, as the last sentence above indicated, review of internal emails suggested that executives were more worried about revenue than quality of care or patient outcomes: <blockquote>A review of those communications reveals that rather than asking whether patients had been harmed or whether regulators needed to be contacted, hospital officials asked for information on how the physicians’ activities affected the hospitals’ bottom line. </blockquote> Avoiding Caring for Poor Patients in the Emergency Department On the other hand, the impetus for triaging away apparently less acutely ill patients from the Emergency Department was to avoid such patients who could not pay. The <a href="http://www.nytimes.com/2012/08/15/business/hca-giant-hospital-chain-creates-a-windfall-for-private-equity.html">second NY Times article </a>noted there was a way for supposedly less ill patient to get Emergency Department treatment, <blockquote>Patients whose ailments were not deemed urgent were told to go somewhere else, like a free clinic, or that they could be treated if they paid the co-payment for their insurance or around $150 in cash. </blockquote> In addition, there is reason to think that HCA management pushed health care professionals to put off increasing numbers of patients, regardless of their clinical problems, <blockquote>Several former emergency department doctors at Lawnwood Regional Medical Center in Fort Pierce, Fla., said they frequently had felt compelled to override the screening system in order to treat patients. </blockquote>Also, <blockquote>'Physicians had a really, really hard time with it,' said Dr. J. Patrick Pearsall, who worked for an emergency physician group based in Houston that worked in HCA hospitals. When the doctors failed to meet the hospital’s goals for how many patients should be considered emergencies, 'they really started putting pressure on.' One emergency room doctor who worked at an HCA Florida hospital said doctors had been told they had targets to hit. The doctors’ concerns about the screening policy were acknowledged in an e-mail reviewed by The Times that was sent to the doctors at the hospital in early 2008 by an outside company that worked in the emergency room. The doctors were told HCA’s regional executives were 'quite intent on pursuing this program at least for the time being and fully expects us to comply. Their expectations are that approximately 15 percent of all patients are to be screened and of those screened no more than 35 percent overridden.' </blockquote> Keep in mind that variations in patient populations over time and across geographic areas means that the proportions of more and less severely ill patients showing up at individual Emergency Departments will vary substantially. Pressuring health care professionals to turn away a minimum percentage of people will make it very likely that at some times severely acutely ill patients will not be seen. So it appears that at HCA, patients sometimes were overtreated, and sometimes were undertreated, and that executives trying to increase revenue may have been more responsible for both than simple human error. Finally, there is reason to think that the take-over of HCA by private equity (that is, leveraged buy-out) firms further increased the for-profit corporation's emphasis on short-term revenue leading to worsening quality of care. Private Equity Pushed for Even More Short-Term Revenue The second NY Times <a href="http://www.nytimes.com/2012/08/15/business/hca-giant-hospital-chain-creates-a-windfall-for-private-equity.html">article</a> first noted, <blockquote>During the Great Recession, when many hospitals across the country were nearly brought to their knees by growing numbers of uninsured patients, one hospital system not only survived — it thrived. In fact, profits at the health care industry giant HCA, which controls 163 hospitals from New Hampshire to California, have soared, far outpacing those of most of its competitors. The big winners have been three private equity firms — including Bain Capital, co-founded by Mitt Romney, the Republican presidential candidate — that bought HCA in late 2006. HCA’s robust profit growth has raised the value of the firms’ holdings to nearly three and a half times their initial investment in the $33 billion deal. The financial performance has been so impressive that HCA has become a model for the industry.</blockquote> Note that the private equity firms extracted a considerable amount of cash from HCA at the time they turned it back into a publicly held for-profit corporation: <blockquote>In 2010, buoyed by robust growth in profit, HCA was able to issue billions of dollars in debt that was used to pay funds overseen by the three buyout firms nearly $1 billion in dividends — each. In the spring of 2011, in one of the most closely watched public offerings since the financial crisis, HCA became a public company once again. Its three buyout owners each sold another $500 million worth of stock, allowing them to recoup all their initial investment.</blockquote>By thus increasing the new public corporation's debt load, they further increased pressure on its executives to bolster short-term revenue. However, <blockquote>As HCA’s profits and influence grew, strains arose with doctors and nurses over whether the chain’s pursuit of profit may have, at times, come at the expense of patient care. </blockquote> Summary:  Why No Hospital Should be For-Profit? Among all developed countries, I believe only the US has such a high proportion of for-profit hospitals, and physicians employed by for-profit corporations to take care of patients. However, in summary, this case shows there is evidence that - The management of one for-profit hospital chain was pushed to focus even more on short-term revenue by a leveraged buy-out engineered by private equity firms - This focus lead management to pressure health care professionals to increase revenue, even if that required over- or under-treating patients - The resulting over- and under-treatment likely harmed patients. As a Tampa Bay Times <a href="http://www.tampabay.com/opinion/editorials/hcas-prescription-for-profits/1245248">editorial</a> put it, <blockquote>the allegations suggest a disturbing pattern of endangering patients, and they again expose the weaknesses of a health care system driven by volume and profit rather than efficiencies and patient outcomes.</blockquote> In a <a href="http://www.forbes.com/sites/stevedenning/2012/08/15/private-equity-wont-fix-health-care-either/">column</a> in Forbes, Steve Denning warned, <blockquote>The hospitals owned by private equity are making money in the short-term at the expense of Medicare and the economy. But when the private equity firms depart, as they plan to do, they leave the hospitals with a load of debt, dispirited doctors and nurses, and a bankrupt Medicare system, with serious questions as to whether overall care has been maintained, let alone improved. The current bonanza for private equity from milking Medicare is a bubble that cannot be sustained.</blockquote> We have <a href="http://hcrenewal.blogspot.com/2012/04/health-care-dysfunction-explained-by.html">noted</a> how health care organizations have increasingly been "financialized," lead by executives who put short-term revenue generation ahead of all other goals, including good patient care. Furthermore, hospitals are increasingly likely to be formally for-profit, and hence likely to be lead by such executives. Worse, hospitals are increasingly likely to be owned by <a href="http://hcrenewal.blogspot.com/search/label/private%20equity">private equity</a> firms, further increasing the emphasis on short-term money making. Even worse, physicians are now more frequently <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">employed by such organizations</a>, which may pressure them to do what it takes to increase revenue, no matter what the effect on patients' and the public's health. The probably effects on the quality of care, access, and costs are obvious. In my humble opinion, before the health care bubble bursts, we need to challenge the notion that direct health care should ever be provided, or that medicine ought to be practiced by for-profit corporations. Before market fundamentalism became so prominent, many stated prohibited the corporate practice of medicine, and the American Medical Association <a href="http://hcrenewal.blogspot.com/2007/12/relman-in-jama-on-threats-to-physicians.html">forbade the commercialization of medicine.</a> It is time to heed that wisdom. I submit that we will not be able to have good quality, accessible health care at an affordable price until we restore physicians as independent, ethical health care professionals, and until we restore small, independent, community responsible, non-profit hospitals as the locus for inpatient care. As Todd Hixon wrote, surprisingly <a href="http://www.forbes.com/sites/toddhixon/2012/08/16/where-the-market-approach-to-health-care-completely-fails/">in Forbes</a>, <blockquote>I believe a big part of the answer lies in changing the idea that health care should be a path to riches. There are professions, like university teaching and research, where a big part of the motivation is helping people and gaining respect in the community. If we could shift the balance for health care providers in that direction, solving problems like the one manifest at HCA would be a lot more possible.</blockquote> True health care reform will require an end to market fundamentalism in health care. Note - See also <a href="http://runningahospital.blogspot.com/2012/08/lets-do-numbers.html">comments</a> by Paul Levy in the Not Running a Hospital Blog.

Paging Doctor EBDITA - How Private Equity May Push Hospitals to Put Revenue Ahead of Patient Care

Issues raised by the increasing influence of private equity firms in the direct care of patients were illuminated by a series of articles a...

Đọc thêm »

Health IT difficulties and controversial excuses from health IT hyperenthusiasts and extremists

As I observed at my Aug. 15, 2012 post "<a href="http://hcrenewal.blogspot.com/2012/08/contra-costas-45-million-computer.html">Contra Costa's $45 million computer health care system endangering lives, nurses say</a>" and other posts, common in case reports of health IT difficulties is the refrain (usually from a seller, healthcare executive or health IT pundit) that: <ul><li>It's a rare event, it's just a 'glitch',  it's teething problems, it's a learning experience, we have to work the 'kinks' out, it's growing pains, etc.</li></ul> Or perhaps worse: <ul><li>Patient safety was not compromised (stated long before the speaker or writer could possibly know that).</li></ul> What these statements translate to:  any patient harm that may have resulted is for the "greater good" in perfecting the technology. Here is the problem with that: These statements, while seemingly banal, are actually highly controversial and amoral. and reflect what can be called "faith-based informatics beliefs" (i.e., enthusiasm not driven by evidence). They are amoral because they significantly deviate from accepted medical ethics and patient rights, especially regarding experimentation or research such as the plain language of the <a href="http://history.nih.gov/research/downloads/nuremberg.pdf" target="_blank">Nuremberg code</a>, the <a href="http://videocast.nih.gov/pdf/ohrp_belmont_report.pdf" target="_blank">Belmont Report</a>, World Medical Association <a href="http://history.nih.gov/research/downloads/helsinki.pdf" target="_blank">Declaration of Helsinki</a>, <a href="http://www.nccamwatch.org/research/human_guidelines.pdf" target="_blank">Guidelines for Conduct of Research Involving Human Subjects at NIH</a>, and <a href="http://bioethics.od.nih.gov/IRB.html" target="_blank">other documents</a> that originated out of medical abuses of the past. Semantic or legal arguments on the term "research", "experimentation" etc. are, at best, misdirection away the substantive issues.  Indeed, for all practical purposes the use of unfinished software (or software with newly-minted modifications) that has not been extensively tested and validated and that is suspected to or known to cause harm, without explicit informed consent, is contrary to the spirit of the aforementioned patients' rights documents. They are excuses from health IT hyper-enthusiasts ("<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html" target="_blank">Ddulites</a>"), who in fact have become so hyper-enthusiastic as to ignore the ethical issues and downsides.  The attitude gives more rights to the cybernetic device and its creators than to the patients who are subject to the device's effects. These excuses are, in effect, from people who it would not be unreasonable to refer to as technophile extremists. -- SS Addendum: The <a href="http://videocast.nih.gov/pdf/ohrp_belmont_report.pdf" target="_blank">Belmont Report</a> of the mid to late 1970's, long before health IT became at all common, actually starts out with a section discussing "BOUNDARIES BETWEEN PRACTICE AND RESEARCH."  I have updated one of the observations in that section to modern times: <blockquote class="tr_bq"> ... It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research. ... When a clinician [or entire healthcare delivery system - ed.] departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research. Radically new procedures of this description [such as use of cybernetic intermediaries to regulate and govern care - ed.] should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation [such as health IT - ed.] be incorporated into a formal research project. </blockquote> Health IT appears to have been "graduated" from experimental to tried-and-true without the formal safety research called for in the Belmont report. The Belmont report continues: <blockquote class="tr_bq">Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects. </blockquote> Instead, what we have for the most part are excuses and special accommodations for health IT, on which the <a href="http://hcrenewal.blogspot.com/2011/02/updated-reading-list-on-health-it.html" target="_blank">literature is conflicting</a> regarding safety and efficacy, all the way up to the <a href="http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html" target="_blank">Institute of Medicine</a>. -- SS

Health IT difficulties and controversial excuses from health IT hyperenthusiasts and extremists

As I observed at my Aug. 15, 2012 post " Contra Costa's $45 million computer health care system endangering lives, nurses say "...

Đọc thêm »

EHR sabotage for ransom: Try this with paper!

I have frequently written that health IT, touted as a technology that will deterministically "transform medicine", allows (aside from clinical chaos) new sorts of problems, such as information security abuses en masse, to occur.  See this query link for numerous postings on that topic:  <a href="http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy">http://hcrenewal.blogspot.com/search/label/medical%20record%20privacy</a> I am not, of course, advocating a return to paper; I am in fact "pro-good IT" but "anti-bad IT." "Bad IT" is IT that interferes with quality patient care for any reason, permits evidence spoliation, permits overbilling, exposes confidential medical information to unauthorized parties, etc. Here is another example of unintended consequences of bad health IT.  Try this trick with paper: <blockquote class="tr_bq"><a href="http://www.cio.com/article/713605/Attackers_Demand_Ransom_After_Encrypting_Medical_Center_s_Server" target="_blank">Attackers Demand Ransom After Encrypting Medical Center's Server</a> John E Dunn, Techworld August 14, 2012  Details have emerged of an extraordinary data breach incident in which a U.S. medical practice had thousands patient records and emails encrypted by attackers who then demanded a ransom to unscramble the data. The incident appears to have come to light after a security blogger 'Dissent Doe' noticed a data breach report made by Illinois-based The Surgeons of Lake County medical centre to the US Department of Health and Human Services. According to a small newswire that reported events, attackers were able to compromise one of the medical centre's servers, encrypting its contents including 7,067 patient records and a quantity of emails. The first the centre knew about the attack was on 25 June when a ransom note for an undisclosed sum was posted on the server, at which point it was turned off. It is not clear whether the data was recovered through backups but the organisations reported the incident to the police and Department of Health. ... What marks the compromise out from almost every data breach attack recorded is that the attackers opted to extort the victim organisation rather than attempting to sell or exploit the data itself.  [Cyber criminals should never be assumed to be uncreative - ed.] It remains unlikely that the intention was to abuse this data directly; having occurred only days before the extortion note was received, the criminals would normally want a longer period to execute data and identity theft crimes. Most data theft criminals attempt to go undetected for this reason. The criminals will, nevertheless, had access to sensitive data including names, addresses, social security and credit cards numbers plus medical records, prompting the centre to inform its affected patents of the breach. "This is a warning bell. Maybe they're the canary in the coal mine that unpredictable things can happen to data once it's digitized," [you think? - ed.] said Santa Clara University law school professor, Dorothy Glancy, quoted by Bloomberg. </blockquote> This incident is, quite simply, stunning.  In addition to identity theft concerns, a patient whose information was cybernetically 'held hostage' could have suffered clinically as a result. A warning bell indeed about "bad IT." -- SS

EHR sabotage for ransom: Try this with paper!

I have frequently written that health IT, touted as a technology that will deterministically "transform medicine", allows (aside f...

Đọc thêm »