Cook Medical Interview Discussing PAD Leg Therapies Rob Lyles, VP Peripheral Intervention Division

The stent has been approved in Europe already.  In addition another article of interest was an interview I did a while back with UCLA Dr. Peter F. Lawrence, Director of the UCLA Gonda Vascular Center who treats patients for PAD.   BD

The UCLA Gonda Vascular Center Treats PAD (Peripheral Arterial Disease)-Interview with Dr. Peter Lawrence Chief of Vascular Surgery

Zilver PTX Stent from Cook Medical Gains CE Mark Treatment for Peripheral Arterial Disease (PAD)

Oct. 11 (Bloomberg) — A drug-coated stent from Cook Medical met safety and effectiveness goals in the treatment of blocked femoral arteries, according to a staff report by U.S. regulators weighing whether to clear the device for sale.

Clinical trials showed closely held Cooks stent, the Zilver PTX, worked as well as or better than angioplasty and non-medicated stents in unclogging vessels, Food and Drug Administration staff said in a preliminary review released today on the agencys website. Outside advisers to the FDA will meet Oct. 13 to evaluate the findings.

The device from Bloomington, Indiana-based Cook would be the first drug-coated stent approved in the U.S. to treat peripheral vascular disease in the largest artery of the upper leg. The stent could reduce leg amputations and painful bypass surgeries, the company said after winning approval for the device in Europe two years ago.

http://www.businessweek.com/news/2011-10-11/cook-s-stent-met-efficacy-safety-goals-fda-staff-says.html

99 Percenters

A growing number of protesters are calling themselves the ”99 Percenters,” (Alter, Jonathan.  Why Occupy Wall Street Should Scare Republicans.  Bloomberg, October 6, 2011.  Link here) referring to those who are not in the top 1% of earners.  (The top 1% of income is clearly greater than $250,000/ year [see 2009 census data on US household income here], and likely around $380,000 a year [based on the distribution of income reported on tax returns here.]) 

In health care, nearly all who are paid more than $380K/ year are either proceduralists (some medical sub-specialist physicians, and some surgeons, again mainly sub-specialist), or managers and executives of health care organizations.

Health Care’s 1% 

We have been discussing since 2007 how the inequality among physicians’ incomes favoring those who do procedures over primary care and other “cognitive” physicians has been driven not by the market, but by regulatory capture.  The fees paid for all physicians services by Medicare, a fee schedule adopted without question or major changes by nearly all insurers, are set through the Resource Based Relative Value System (RBRVS) by the US Center for Medicare and Medicaid Services (CMS).  CMS, in turn, gets virtually all its input on these fees from the RBRVS Update Committee (RUC), a private committee of the American Medical Association (AMA), made up largely of proceduralists, whose deliberations are secret, and whose membership has been secret until recently.  See here for most recent posts.  Note that the CMS’ peculiar relationship with the RUC is now subject of a lawsuit that accuses this relationship of violating the Federal Advisory Committee Act (Klepper B, Kibbe D. A legal challenge to CMS’ reliance on the RUC.  Health Affairs Blog, August 9, 2011.  Link here) 

The real top earners in health care, however, are not physicians, but executives of big corporations, non-profit and especially for profit.  We have discussed endlessly how huge their compensation may be, and how it seems unrelated to any aspect of their own or their organizations’ performance, especially not to how much they benefit patients’ or the public’s health.  Furthermore, we have noted how executives have prospered even when their management seems overtly hostile to the health care mission, when it leads to ethical missteps requiring legal settlements, or even guilty pleas or verdicts to criminal charges. 

So health care’s “99 percenters” ought to be angry at the top 1%.

The Power of Finance

Furthermore, the Occupy Wall Street protesters are not merely upset with the upper 1%, but particularly outraged by those in the financial sector, which “with regulators and elected officials in collusion, inflated and profited from a credit bubble that burst, costing millions of Americans their jobs, incomes, savings and home equity.”  Then, “the initial outrage has been compounded by elected officials’ hunger for campaign cash from Wall Street, a toxic combination that reaffirmed the economic and political power of banks and bankers, while ordinary Americans suffer.  Extreme income inequality is the hallmark of a dysfunctional economy, dominated by a financial sector that is driven as much by speculation, gouging and government backing as by productive investment.” (Anonymous. Protesters against Wall Street.  NY Times, October 8, 2011. Link here)

In another report, the protesters “unite around a common theme: bankers are ripping off America.  Two secondary themes also emerge….  One is that the super rich own the politicians.  The other is that the news media, almost across the board, view events through the eyes of the super rich.” (Johnston DC. Occupy Wall Street.  Reuters Blogs, October 7, 2011.  Link here.)

Finance’s Links to Health Care

We have noted parallels between the effects of Wall Street and health care on the economy.  Furthermore, we have noted active ties among Wall Street and health care organizations. (Look here for examples.)  Top executives and board members of some of the financial firms most obviously responsible for the global economic collapse/ great recession have served on boards of trustees of top medical schools and academic medical centers, and their parent universities.  The top leaders of medical schools, academic medical centers, and their parent universities have served on the boards of such financial firms.  There are also board interlocks among Wall Street firms and all sorts of health care corporations.  The corporate culture of Wall Street and health care have long overlapped. 

We have further noted how the leadership of big health care organizations has deceptively influenced policy, particularly through stealth health policy advocacy.  Meanwhile, until the last few years, much of health care dysfunction has been anechoic.  Now the media is beginning to report some of the abuses.  Little about them appears, however, in the medical and health care literature that health care professionals are likely to trust more than news media. 

Summary

We have frequently suggested that true health care reform requires reform of health care leadership and governance.  We need leaders who understand the health care context, uphold health care professionals’ values, and put patients first.  We do not need leaders who are ill-informed, incompetent, self-interested, conflicted, or corrupt.  We need governance that is accountable, honest, transparent, ethical, and again puts patients first.  Maybe to do that we will have to “occupy health care.”

In any case, it is time for health care’s “99 percenters” to stand up for their patients and the integrity of their values. 

Walgreens Going to Sell Health Insurance? Data Information Connections Are Alive to Mine for Potential Premiums Rates & Chronic ConditionsInsurance Subsidiary Alert

You wonder sometimes is providing drugs a secondary interest as they need to sell drugs to get the data right?  Profit margins on data are huge as they dont have to stock it, order the drugs from a pharmaceutical company, just collect from the data scraping and other tools out there to mine the information.  United has a plan in place in some areas in the US to where the pharmacists can earn pay for performance for signing people up in programs such as the YMCA and others, and this brings more data into play and of course as a consumer it is something that is healthy of course, but they make money, bottom line.  The analytics end of United, Optum, formerly known as Ingenix is one of the companies that has been selling prescription data for years. 

By increasing understanding of potential disease conditions and relative risk, MedPoint enables underwriters to more accurately project future claims costs on a case-by-case basis.

United Healthcare Expanding Diabetes Prevention & Predictive Algorithm Program With Walgreens And Pay for Performance Incentives In Atlanta

The prevention arm will use UnitedHealth claims data and other demographic information to flag people at risk of developing diabetes and invite them to a free, 16-session exercise and nutrition class at a local YMCA. Theyll have monthly follow-up after the class is over, and instructors will be paid bonuses if participants meet certain modest weight-loss goals.

I thought this article was interesting too about how pay for performance is not all it has cracked up to be as folks seem to making money at some part of this but no better outcomeshmmm.report from Harvard. 

Pay For Performance Is Not All That It Has Cracked Up to Be-Time to Rethink As Money Is Not Creating Better Health Outcomes

If these areas dont bring in more money, well theres always alcohol and how does that play into better care <grin> 

Walgreens Applying For and Getting Liquor Licenses Across the US Be Healthy and Get Your Alcohol Here Too

I dont know what the chances would be with selling Blue Cross insurance since as of the first of the year unless anything changes, consumers wont be able to fill their prescriptions at Walgreens. 

Anthem Blue Cross Members Will No Longer Be Able to Fill Prescriptions at Walgreens After January 1, 2012

Granted this has to do with the pharmacy benefit management end of things with Express Scripts as they dont have the retail sales data to add to prescription data to create information rich behavioral analytics to sell, they just have data and any information they gather with conversing with consumers so the retail folks have truckload of data to include every bottle of wine, candy bar or what ever you may purchase in the store to relate to your medicationsthink about that folks as all are aggregating and selling data today and dont think they aren’t.  If you are filling a prescription for diabetes, they can match it to that package of M and Ms you buy a the same time or any other time in the store.

We have too many folks today creating markets where they really do not exist and some of the numbers we see are just for that, marketing and data gets mismatched and abused and ends up taking away for profit.  A good example of an over sell this this circus with FICO that I hope someone calls them on it with using your credit score and other data to determine if you will take your medications and they are selling this to pharma and insurance companies with scoring you. 

Hell, even the algorithm that Netflix uses to determine what you will like is only 60% on target so look at what a fleecing this is with misuse of numbers.  Listen to the audio at the link below and all of this will become clear to you and make you think about how numbers are used for profit and are not always what they seem to be, the dirty algorithms.  theres a link to the FICO story there and you can read all about this abuse of data and how it will affect you. 

Numbers Dont Lie, But People DoRadio Interview from Charles SiefeJournalists Take Note, He Addresses How Marketing And Bogus Statistics Are Sources of Problems That Mislead the Public & Government

Speaking of FICO and their fleecing the public algorithms, check this out, they just hired  a new director and where did he come from, you guessed it, United Healthcare.  Getting a big name on board in healthcare will help defend those bogus algorithms maybe, either that or open doors to sell those medication compliant bogus algorithms to someone where they can convince there is a market for it and I hope pharma is smart enough to bow out on that sale. 

Are  you getting the picture yet on how this is all intertwined here for profit, the stuff that the protesters are occupying Wall Street to bring this to light.   

So time will tell if Walgreens starts selling insurance but big big question, can you go into the store to settle a claim dispute??  OH yes that should definitely be part of the plan if one is going to be full service here and offer exchange services.  I think we would all save a lot of money and be much better off with a tech company doing this since the insurance exchanges and their existence and creation is all based on a strong IT infrastructure that HHS keeps handing grants out to help states get set up.  Let eBay do it as they have a platform that could do it as far as selling and price comparing. 

eBay and PayPal Expanding Mobile Technology Opening Up Platform to Allow 3rd Party DevelopersCould it Handle Insurance Exchanges & Save a Ton of Money?

Well they all must have some really expensive anti-trust attorneys on staff is about all I can say and one more comment here, did you know that United created a new subsidiary to be in the medical devices business?  I call these articles subsidiary watch as everyone is oblivious as to how they work behind the scenes with data and intelligence today and its a sleeper so I hope all wake up soon as those algorithms along with very little awareness allows them to function and take over.  This appears to be their first big step with devices since acquiring China Gate a couple of years ago and who knows what drugs or biotech will be next and they could theoretically control the whole process of introduction to the FDA all the way to MD reimbursement as they have subsidiaries that can all the work, again subsidiary watch .please.  So who knows, if Walgreens decides to sell insurance maybe United will be the first insurance they would sell, as collaboration and profit efforts are already in place in some areas between the 2.  BD 

United HealthCare Gets In the Medical Device BusinessDistributing Cheap Hearing Aides Sold Via Hi HealthInnovations Division Subsidiary Watch

Imagine walking into your corner drugstore to pick up aspirin, toothpaste and individual health insurance.

That day might not be so far away. Walgreens reportedly may enter the health insurance marketplace this fall, selling a variety of health plans at a variety of price points, although the company has not confirmed such reports.

Walgreens’ possible entrance into the health insurance market is a result of a health care reform legislation mandate that will establish health insurance exchanges to offer coverage options. The exchanges must be in place by Jan. 1, 2014.

Ankeny Minoux, president of the nonprofit Foundation for Health Coverage Education, speculates that companies are holding off making announcements about plans to enter the health insurance arena because the formal rules under which they would operate haven’t been established yet.

http://www.foxbusiness.com/personal-finance/2011/10/06/would-buy-health-insurance-from-your-drugstore/

I fear that these problems will become far more commonplace under the “incentives” and penalties for “non-meaningful” users of “certified” health IT (incentives = “take our incentives and use this stuff, or we will punish you”).

These posts should be read in sequence:

1. “On EHR Warnings: Sure, The Experts Think You Shouldn’t Ride A Bicycle Into The Eye Of A Hurricane, But We Have Our Own Theory”, http://hcrenewal.blogspot.com/2011/07/on-ehr-warnings-sure-experts-think-you.html

2. “The Issues at This Site, Started in 1999, Are Not Academic or Theoretical. My Own Mother Was Maimed by a Health IT-Related Problem Last Year“, http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=bcs

3. “Saving My Mother From Being Maimed Twice. MAUDE Adverse Event Report - Life Threatening; Hospitalization Required”, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1729552

4. “Saving My Mother Again. EMR Problems? No, They’re Merely Anecdotal; the Truth Must Be That I Attract Bad Electrons and Stale Bits”, http://hcrenewal.blogspot.com/2011/01/ehr-problems-no-theyre-merely.html

5. “Saving My Mother yet Again. EHR Legible Gibberish - Another Example, the ED EHR Allergy List - And Legal Threats for Exposing Problems”, http://hcrenewal.blogspot.com/2011/03/ehr-legible-gibberish-another-example.html

6. “My mother passed away”, http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html

7. Aftermath - “There Are Still Some Medical Watchdog Organizations That Call a Spade a Spade”, http://hcrenewal.blogspot.com/2011/10/there-are-still-some-medical-watchdog.html

This is a cautionary tale of the most profound kind regarding one of the biggest non-consensual medical experiments in history.

– SS

U.S. drug regulators approved Eli Lilly’s Cialis drug to treat enlargement of the prostate, expanding use of the blockbuster impotence medicine.

The Food and Drug Administration said Cialis could be labeled for treatment of the signs and symptoms of a non-cancerous enlarged prostate, called benign prostatic hyperplasia (BPH), and also be used for people who have both BPH and erectile dysfunction.

About half of men over 50 suffer from prostate problems, which can cause difficulty urinating.

"BPH can have a big impact on a patient’s quality of life," said Scott Monroe, director of the FDA’s division of reproductive and urologic products. "Cialis offers these men another treatment option, particularly those who also have ED (erectile dysfunction), which is also common in older men."

In an interview in July, Eli Lilly CEO John Lechleiter said he expects the longer-lasting Cialis to overtake Pfizer’s Viagra to become the market leader for impotence drugs.

http://www.foxnews.com/health/2011/10/07/fda-oks-cialis-for-enlarged-prostate/

Orange County California REC Center For Doctor Assistance with Medical Records Appears to be a Bust So Far

Services for PracticesLA County first then the OC

Meaningful Use Information

How to Register for EHR Incentives

EHR Vendor contracts

October 5, 2011
New York Times
Patient Data Landed Online After a Series of Missteps

By KEVIN SACK

Private medical data for nearly 20,000 emergency room patients at Californias prestigious Stanford Hospital were exposed to public view for nearly a year because a billing contractors marketing agent sent the electronic spreadsheet to a job prospect as part of a skills test, the hospital and contractors confirmed this week. The applicant then sought help by unwittingly posting the confidential data on a tutoring Web site. [Got all that? - ed.]

In an e-mail sent to a victim of the breach, the billing contractor, Joe Anthony Reyna, president of Multi-Specialty Collection Services in Los Angeles, explained that his marketing vendor, Frank Corcino, had received the data directly from Stanford Hospital, converted it to a new spreadsheet and then forwarded it to a woman he was considering for a short-term job.

The position was with Mr. Corcinos one-man shop, Corcino & Associates, Mr. Reyna wrote in the e-mail, which was authenticated by his lawyer, Ellyn L. Sternfield. The job applicant apparently was challenged to convert the spreadsheet which included names, admission dates, diagnosis codes and billing charges into a bar graph and charts, Stanford Hospital officials said.

Not knowing that she had been given real patient data, the applicant posted it as an attachment to a request for help on studentoffortune.com [I wrote about that earlier here - ed.], which allows students to solicit paid assistance with their work. First posted on Sept. 9, 2010, the spreadsheet remained on the site until a patient discovered it on Aug. 22 and notified Stanford.

My, how electronic data can travel when mishandled. Try that trick with 20,000 paper charts …

The hospital, located on the campus of Stanford University in Palo Alto, demanded that the spreadsheet be removed, and the Web site quickly complied. Pressed for time, the job prospect wound up completing the assignment herself and, in the end, did not get hired, Ms. Sternfield said.

Ironically, this was all for naught.

Mr. Corcino, in his first public statement, attributed the breach to a chain of mistakes which are far too easy to make when handling electronic data.

Far to easy to make - especially by the dyscompetent.

… Breaches of private medical data have become distressingly commonplace, with two substantial ones disclosed in the last week alone. [We don't know the details of those yet; that's for next week - ed.]

Case 2: Pandemonium (from same NYT article)

In Orlando, officials with Florida Hospital reported that three employees had improperly combed through emergency department records of 2,252 patients, apparently to forward information about accident victims to lawyers. The employees were fired, and law enforcement officials are investigating.

Trolling for Torts - is this a new EMR TV game contestant show? Perhaps it could be followed by “Trolling for Tarts?“

Case 3: Bedlam (from the same NYT article)

Meanwhile, Science Applications International Corporation disclosed that computer backup tapes containing medical data for 4.9 million military patients [that number also amounts to almost 2% of the total U.S. population - ed.] had been stolen from an employees car in San Antonio. The data included Social Security numbers, clinical notes, laboratory test results and prescriptions. The company said the risk of harm was low because retrieving data from the tapes would require specialized knowledge, software and hardware. [Who's to say the theft was not by someone with that specialization, or someone paid by same to steal the tapes? - ed.]

The Texas breach is by far the largest since September 2009, when a new federal law began requiring disclosures of medical privacy violations involving at least 500 people. Some 330 such episodes have been tallied, including four others that affected more than one million people each.

We’d all be buried in stray clinical paper by now if it weren’t for computers. Thank god for them!

Officials at the Department of Health and Human Services said the new reporting requirements had exposed deep vulnerabilities and encouraged renewed vigilance.

Exposed to whom? The blind, deaf and dumb?

Were moving in the right direction in terms of a culture of compliance, said Leon Rodriguez, director of the departments Office for Civil Rights, which investigates medical privacy cases. Are there still a lot of problems out there? Yeah, my sense is there are still a lot of problems.

The Titanic was moving in the right direction - towards New York Harbor, in fact, when it met a little unexpected obstacle. Perhaps a culture of brains would be better than a culture of compliance…

The Stanford breach was notable for the duration of public exposure, and for spotlighting the vulnerability created by a medical providers business relationships with outside parties.

Last week, lawyers filed suit in state court in Los Angeles, seeking certification as a class action and $20 million in damages from Stanford Hospital & Clinics and Multi-Specialty Collection Services, which is known as MSCS.

$20 million might hurt a bit, and might help motivate the organization to hire better and/or more appropriate clinical information management expertise - in house where it belongs (see below).

The threat of liability set off a predictable round of finger-pointing.

In written responses to questions, Lisa Lapin, Stanford Universitys assistant vice president for university communications, said, MSCS bears the complete and sole responsibility for the breach.

It’s their fault, not ours.

Ms. Lapin said the hospital had sent the data in encrypted form to Mr. Corcino, who requested it on behalf of MSCS to analyze a strategy for improving billing collections. She said Mr. Corcino had regularly represented himself as MSCSs executive vice president and had been Stanfords primary contact during a seven-year relationship. MSCS, a five-person firm that audits hospital accounts to maximize reimbursement, possessed the passwords to unencrypt the data, she said.

It was all about money and outsourcing.

This mishandling of private patient information was in complete contravention of the law and of the requirements of MSCSs contract and is shockingly irresponsible, the hospital said in a statement.

It is foolish to believe that someone else can run critical aspects of your business, and it is even more foolish to believe that it is OK for someone else to run critical aspects of your business.

Ms. Sternfield, Mr. Reynas lawyer, said Mr. Corcino had never been an MSCS employee, but rather was paid a monthly fee to drum up business, typically in face-to-face meetings with health care executives. Mr. Reyna, she said, had no knowledge that the Stanford data had been sent to Mr. Corcino, or that he had passed it on.

Mr. Corcino was not authorized to use an MSCS title, Ms. Sternfield said, but she declined to say whether Mr. Reyna was aware of the practice. She acknowledged that Mr. Corcino sometimes used an MSCS e-mail account.

In his e-mail to the breach victim, who shared it with The Times, Mr. Reyna wrote that Stanford had sent the file to Mr. Corcino for a potential MSCS project that would audit paid accounts to verify that the reimbursement was correct.

For his part, Mr. Corcino said in a statement that he was an independent contractor but was the marketing face of the company, and that MSCS allowed me to use the title of executive vice president. He wrote: Stanford sent the file to me at MSCS, and I imported the data into a spreadsheet that was forwarded to the job applicant as part of a skills test. I did not intend to provide any personal health information in the file. This was a marketing project.

Without explaining how or why he sent the data to the applicant, Mr. Corcino said MSCS had not trained him properly and faulted Stanford for sending him private information that he did not need. That, he said, was the first link in a chain of mistakes.

I regret that Stanford released a file containing unnecessary information, Mr. Corcino said, that MSCS did not have an appropriate training and audit system for the handling of electronic data and that I was not more careful with the file. While Stanford and MSCS left the information in the file I received, it was my mistake to not catch its inclusion and remove the data. … The hospital has terminated its relationship with MSCS, and Mr. Reyna has done the same with Mr. Corcino.

Even I can’t follow all that. This will be one convoluted court case…

Stanford Hospital has reassured affected patients that the posted spreadsheet did not contain Social Security numbers, birthdates or credit card numbers, and has offered free identity theft protection services. The hospital said it had not uncovered any misuse of the exposed data.

Yet, that is. (Is it no wonder that sedatives are among the most highly-prescribed medications?)

Moving from the NYT article:

Case 4: Tumult (I’m running out of descriptors)

A large class action lawsuit again Health Net and IBM:

California Legal
Westlaw Journal Insurance Coverage

Health Nets, IBMs negligence compromised medical data, suit says

June 7 (Westlaw Journals) - Health Net Inc. and IBM face a class-action lawsuit seeking $5 million in damages over the loss of computer storage devices that held the medical histories, financial data and Social Security numbers of 2 million people.

Health Net Policyholder Alana Bournas class-action complaint in the U.S. District Court for the Eastern District of California alleges that the insurer and IBM breached their duty of confidentiality and negligently allowed the release of highly personal and confidential information of millions of Health Net employees and policyholders.

The complaint alleges violation of Californias Confidentiality of Medical Information Act, Cal. Civ. Code 56; Cal. Civ. Code 1798.2, which concerns the unauthorized disclosure of customer records; Cal. Bus. & Prof. Code 17200, the states unfair-competition law; and public disclosure of private facts.

Companies will either pay the going price for competent employees, or pay for the mistakes of incompetent ones. It would probably be better for society, however, to do the former habitually.

The suit says IBM agreed to manage Health Nets information technology database for five years beginning in 2008.

IBM informed Health Net Jan. 21 that it had lost nine disk drives containing the confidential information of 2 million people, including Health Net policyholders and employees.

Health Net failed to alert the victims of the breach until March 14, the complaint says.

IBM allegedly also failed to encrypt the data, thereby enabling anyone who possesses the hard drives to easily access the confidential information. This puts the victims at an increased risk of identity theft and other unauthorized uses of plaintiff and class members personal information the suit says.

Encryption, a feature now built into mainstream OS’s by Microsoft and Apple? (Oh wait…IBM…)

Health Nets attempt to compensate the victims by providing two years of free credit monitoring services through TransUnion is an inadequate remedy for the defendants conduct, Bournas says. This remedy fails to address unauthorized disclosures of medical information, and the monitoring services only protect against new account fraud but do not address fraudulent activity with existing accounts, the suit says.

These executives apparently can’t even get the fix straight.

Moreover, the complaint says, Health Net has previously been accused of a similar breach of confidential information. In 2009 it lost the same types of records of nearly 1.5 million people and waited six months before notifying the victims. In settling the state of Connecticuts lawsuit stemming from that security breach, the company promised to enhance security procedures and training, the suit says.

What can I say?

The current breach could have been avoided had Health Net and IBM taken proper precautions and implemented security policies to maintain consumers confidential data, according to Bournas. Therefore, the protections granted under California law require that Health Net be penalized for its negligence, she says.

The plaintiff notes that millions of people entrusted Health Net with their private data.

At best, defendants actions allowed this private information to go astray. At worst, the private information is being viewed, sold, resold, and used for illegitimate and illegal purposes, the complaint says.

The suit is seeking injunctive relief, compensatory damages, declaratory relief, and attorney fees and costs.

Bournas v. Health Net Inc., No. 2_11-CV-01262, complaint filed (E.D. Cal. May 11, 2011).

I would revise that to say “The current breach could have been avoided had Health Net and IBM hired personnel in adequate numbers with the qualifications and true gravitas (and not laid them off, of course) to maintain consumers confidential data.”

Case 5: Maelstrom (I am reaching to the bottom of the barrel for such descriptors).

Wellpoint recently settled class-action suit in CA.

AMA news
By Pamela Lewis Dolan, amednews staff.
Posted Aug. 1, 2011.

WellPoint reaches tentative accord in data breach suit

It is the second settlement to come from lawsuits claiming that the company failed to protect the privacy of individual insurance applicants online.

WellPoint has reached a preliminary settlement that will, if approved, bring an end to a class-action lawsuit filed more than a year ago.

The lawsuit, filed in the Superior Court of the State of California, involves the potential exposure of data belonging to more than 600,000 individual health insurance applicants on a company-run website that allowed insurance applicants to track their applications.

The situation came to light when an applicant to WellPoint-owned Anthem Blue Cross of California sued the company in March 2010. The applicant was able to manipulate the web address within the site to gain access to other applicants’ information, including names, addresses, dates of birth, Social Security numbers and health and financial information.

In other words, probably changing a simple number in the URL brought up someone else’s records. Good going there, Wellpoint. What were the programmers thinking? (Were they thinking?)

When the suit was filed, the company said an upgrade to the system caused the information to become exposed. The company said a third-party vendor validated that all security measures were in place when, in fact, they were not. Changes were made to the system soon after the situation was discovered.

Blame someone else, yet again.

In addition to the class-action suit, the company was sued by Indiana Attorney General Greg Zoeller in July 2010. The suit, filed in Marion County Civil Superior Court, alleged that the company violated the Indiana Disclosure of Security Breach Act by failing to notify Zoeller, and the 32,051 Indiana residents affected by the incident, in a timely manner. That suit was settled in early July, when WellPoint agreed to pay a $100,000 fine. As part of the settlement, WellPoint admitted it had a security breach and failed to properly notify the attorney general’s office as required by law.

Gevalt.

Under the preliminary settlement in the California class-action matter, WellPoint agreed to offer credit monitoring for two years to all affected individuals. Class members are eligible to receive reimbursement for identity theft losses of up to $50,000 per incident, as well as additional time to file identity theft claims until May 31, 2016. Those making identity theft claims are eligible for an additional five years of credit monitoring. The company also will donate a total of $250,000 to two nonprofit organizations whose efforts are directed at protecting consumers’ privacy on the Internet.

It might have been cheaper and better for goodwill not to outsource a vital function…those third-party vendors can really hurt you. (I’d really like to know - was this “third party vendor” domestic, or overseas?)

WellPoint did not admit wrongdoing in the case, nor was it found guilty. A fairness hearing is scheduled for November, and the courts then will decide whether to approve the settlement.

Large corporations are immune from such formalities as admitting wrongdoing or being found guilty.

———————–

But don’t worry. Your medical data’s safe.

Sort of. See also:

• “Networked EMR’s and Healthcare Information Security: Practical When Massive IT Security Breaches Continue?”,

• “Networked, Interoperable, Secure National Medical Records a Castle in the Sky?“,

• “Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?“,

• “Medical data breach of the week - but your EMR data is secure, trust us, we’re IT experts“,

• “Insurers Test Data Profiles to Identify Risky Clients“,

• and others

– SS

The US Dispute with Brazil, on Behalf of Merck and Pfizer, About HIV Drugs

When [William] Daley was commerce secretary in the later years of the Clinton administration, Brazil rankled U.S. drug companies by opting to provide its citizens with a generic version of another HIV drug. Like Thailand, Brazil declared a public health emergency in an effort to lower the cost of treating roughly a half-million HIV infections. The U.S. government responded by sending Daley to Brazil with executives from U.S. pharmaceutical giants Merck & Co. and Pfizer to try to pressure the Brazilian government into reversing its decision.

Thus the US government appeared to be putting the revenues of US corporations ahead of the public health, at least in Brazil.
Daley soon made the transition to the private sector:

In a speech at Johns Hopkins University before leaving for Brazil, Daley encouraged students to enter the revolving door between big business and public policy-making. ‘Let me say this: As one of the only members of the president’s Cabinet to come from business, it’s good when you mix both government and business in your careers,’ he said. ‘It makes better public servants, and it makes better businesspeople.’

It has certainly been good for Daley’s career. His effort to twist arms in Brazil failed, but drug companies apparently took note. It was after leaving the Clinton administration that Daley was hired by Abbott, where he raked in more than $1.3 million as a board member from 2004 to 2010, according to Securities and Exchange Commission filings. Over the same period, he served on Boeing’s board and was a top lobbyist for JPMorgan Chase.

Abbot’s Dispute, Supported by the US Government, with Thailand About Kaletra

Soon Abbot was involved in a similar dispute.

The background is:

[HIV drug] Kaletra costs more than $10,000 a year for a patient living in the United States, a price that is reflective of the highly protective American patent system. The U.S. is the only country that grants long-term monopolies on life-saving medicine without regulating the price of monopolized drugs.

In addition

In countries that negotiate with companies on drug prices, the cost of medicine is often far lower. But though American pharmaceutical companies do supply drugs to developing nations at rates below those charged in the U.S., those discounted prices are still too high for many poor or hard-hit nations to afford.

‘In many developing countries, it’s a death sentence,’said Nobel Prize-winning economist Joseph Stiglitz, referring to high drug prices.

The core of the dispute:

In 2007 negotiations with the Thai government, Abbott Labs wouldn’t budge below a price of $2,200 per person, per year for Kaletra. At the time, Thailand was classified as a ‘lower-middle income’ country by the World Bank — the second lowest of four categories. With more than a half-million citizens living with HIV, Thailand considered that price beyond its budgetary capacity. So it declared a public health emergency and began importing a vastly cheaper generic version of Kaletra from India.

And then, by international trade standards, all hell broke loose.

‘When countries declare the health emergency, they face a huge backlash, particularly from the USTR [US Trade Representative] and the drug companies,’said Tim Boyd, policy research coordinator with the AIDS Healthcare Foundation, a U.S. nonprofit dedicated to eradicating HIV.

Abbott responded by withdrawing pending applications to register drugs in Thailand, cutting its citizens off from other medications. The move was unprecedented: Never before had an American drug company attempted to punish a country during drug price negotiations by cutting off the supply of other medicines.

At the time, Brook Baker, a law professor at Northeastern University and a member of the board at the Health Global Access Project, called the move a ‘ruly appalling example of corporate hubris’that ‘irectly violates any conceivable norm of corporate responsibility.’

At that time, the US government went along with Abbott:

As for the USTR, it seemed to support the company, placing Thailand on its ‘Priority Watch List ‘of nations that do not respect U.S. intellectual property rights. ‘In late 2006 and early 2007, there were further indications of a weakening of respect for patents, as the Thai Government announced decisions to issue compulsory licenses for several patented pharmaceutical products,’ wrote the agency in its report announcing that Thailand had been added to the priority list.

Although the USTR blacklist is little known domestically, it is a major economic indicator abroad and can affect a country’s ability to import everything from software to DVDs to automobiles. Thailand’s new status as an international rogue sparked concern among the country’s economic policy officials and corporate leaders. And 35 members of Congress wrote to the USTR to protest Thailand’s blacklisting, noting, ‘The move is being interpreted in the public health community as a warning and a threat to other countries.’

Note that:

Abbott Labs declined to detail Daley’s involvement in the Thailand episode, but as a member of the board, he should have been well informed about the strategy.

US Government Pressure to Protect Drug Companies’ Patents

William Daley has transitioned the revolving door again in the other direction:

As commerce secretary under Bill Clinton, William Daley worked with U.S. pharmaceutical giants to curb the use of cheaper generic drugs abroad. As a board member for Abbott Laboratories, he had a front-row seat on a brutal clash between a major drug company and a developing nation over access to life-saving medication. And as White House chief of staff today, Daley has President Barack Obamas ear.

In his new government job,

Add up Daleys power and experience, and experts who follow public health policy suspect his influence in the U.S. stance in negotiations over a major international trade deal -- a stance with hugely profitable implications for giant American drugmakers.

The United States is in talks with eight other Pacific nations to establish the Trans-Pacific Partnership, which the administration hopes will serve as a template for other trade pacts. According to leaked documents from the negotiations, the Obama administration is using the deal to push hard-line intellectual property standards that could drive up medicine prices overseas, boosting the bottom line for U.S. drugmakers like Abbott Labs at the expense of public health.

Public health advocates are worried. ‘If the point of the trade policy is not just to protect the interests of our companies, but the public health benefit and burden of research, then [the United States] is doing this all wrong,’ said James Love, director of Knowledge Ecology International, a nonprofit that focuses on how patent laws affect the poor.

A White House spokesman said only that the negotiations — which are being conducted behind closed doors with input from corporate lobbyists — are being ‘ably led’ by the United States Trade Representative (USTR) and that Daley is ‘not directing or participating in those negotiations.’

Note that the USTR leadership includes other travelers through the revolving door:

Daley’s personal history with drug access is not unique among top-tier government officials with trade responsibilities. McCoy lobbied on intellectual property issues at the influential D.C. law firm Covington & Burling before moving to the USTR in 2006. His top deputy, Kira Alvarez, was a lobbyist for drugmaker Eli Lilly before joining the agency.

Summary

Per Zach Carter, the author of the Huffington Post article:

Daley, who previously lobbied for JPMorgan Chase, is a prominent examplar of a bipartisan phenomenon in American government in which corporate insiders, and the profit-driven perspective of the boardroom, have come to dominate formal and informal debate over public policy.

Another way to describe this is corporatism. The corporatism in this case is partly enabled by the continuation of the revolving door, the free transit of individuals from leadership positions in top corporations and in government. The government and big corporations have teamed up to produce solutions that may seem beneficial to the people making the decisions, and may benefit their long term career strategies, but may not be good for the US public, for patients’ and the public’s health in this case, and for the ability of the country to conduct foreign policy based on some ethical and moral principles.

By the way, note that combined with other cases we have discussed, this shows that the revolving door pheonomenon, and other aspects corporatism affecting health care are not linked with any one political party.

So,

There is no evidence that any of these players, including Daley, have done anything illegal or explicitly corrupt during the Trans-Pacific trade negotiations. But public health doesnt seem to be their first priority.

‘The real concern is that the U.S. is using its international power and prestige to force poor countries to enforce our intellectual property standards, and the result of that is that access to medicine is denied and people are dying,’ said Joseph Stiglitz.

Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients’ and the public’s health first, way ahead of the financial comfort of corporate leaders.
xx

The civil justice system is slow, subject to legal spin, and not exactly easy to navigate.

Fortunately there are medical watchdog organizations that are not simply figureheads or puppets for large healthcare organizations. They call a spade a spade.

I had filed, at the request of my mother when she was still lucid and living, a complaint in Dec. 2010 with the Medicare Quality Improvement Organization (QIO) in the region where my mother was treated and injured earlier that year.

The QIO investigated and the records were reviewed by an independent expert physician of the appropriate specialty. The QIO’s report is as follows (redacted of names, places and dates; emphases mine):

Dear Mr. Silverstein, [Dr., actually - ed.]

[QIO organization] is the Quality Improvement Organization authorized by the Medicare program to review medical services provided to Medicare patients in [state]. Our responsibilities include a review of medical records to determine whether services meet professionally recognized standards of health care, are medically necessary, and are delivered in the most appropriate setting. We also review written complaints about the quality of Medicare services received by Medicare patients. Where we identify quality concerns, we provide education and feedback to providers and their medical staffs to improve the quality of services they provide in their facilities.

In response to your initial written concern, a QIO physician has reviewed the medical records concerning the services your mother received on 05/##/10 at [YY Hospital].

You are concerned about the following:

Concern:

Your mother was admitted at [YY Hospital] on May ##, 2010. You are concerned regarding the failure of the staff to properly conduct medication reconciliation which resulted in denial of a critical heart rhythm maintaining medicine, Sotalol, to your mother who had been taking it for approximately 8 years.

Response:

A QIO physician reviewer has reviewed the complete medical record for this admission and previous admissions. It was noted that the medication Sotalol was on the 4/##/10 discharge summary and the [later] 4/##/10 ER visit, current medications listed Sotalol 120mg every 12 hours.

It appears that on the 05/##/10 ER visit the current medication list does not include Sotalol and it does not appear that the patient received Sotalol on admission on 5/##/10. Also, the cardiology consult note on 5/##/10 states Sotalol was on hold but that is not clear from the ER note or admission H&P. It appears that Sotalol was not given from 05/##/10 - 05/##/10. Appropriate medication reconciliation of this medication appears not to have been performed. Therefore, a quality of care concern has been identified and confirmed.

Concern:

You are concerned that this failure resulted in lack of continuity of care and many medical complications your mother suffered which include, permanent CNS and cardiac injury as well as increased risk for CVA.

Response:

The QIO physician determined that there is a lack of continuity of care based on the review of the medical records submitted. It appears that the failure to administer Sotalol resulted in the recurrent atrial fibrillation on 5/##/10 and other subsequent medical complications. Therefore, a quality of care concern has been identified and confirmed.

As required by Federal regulations, prior to reaching our decision we gave [YY Hospital] an opportunity to discuss the services your mother received.

After a thorough review of your medical records and any additional information provided by the facility, we determined that the services your mother received did not meet applicable professionally recognized standards of health care. [That phraseology might be considered a technical description of malpractice - ed.]

In addition to determining whether or not care met professionally recognized standards of health care, we have reviewed the medical records pertaining to the services provided to your mother to see if there were any opportunities for improvement.

We share your concern about the quality of service your mother received and have initiated appropriate action as warranted by our review findings. [I was told by QIO representatives that the hospital was required to develop and/or follow a remediation plan to prevent further errors of this kind, and report back to the QIO for several quarters on their progress - ed.]

Before reaching our decision, we gave all involved practitioners and providers an opportunity to review our response concerning the services your mother received.

Please note that the information concerning individual practitioners contained in this letter is confidential and cannot be given out to anyone else, unless that practitioner’s identity is not disclosed or he/she) has given consent.

If you have other concerns regarding this matter, please contact us.

Sincerely,

[Doctor Name]

QIO Medical Director

(It’s regrettable that my mother left this earth before seeing this report.)

So, there are in fact organizations that will not tolerate substandard medical care.

These organizations need to receive increased influence and authority.

Of course, I mentioned early in this post that seeking justice is not a linear process.

It seems part of the problem is that many hospitals have problems with basic honesty, accountability, and medical common sense.

Exhibit one in that regard is the statements from the hospital’s representatives even after Medicare found them to have not met applicable professionally recognized standards of health care:

“Defendant is unable to determine what plaintiff’s claims are.”

On issues of health IT’s role in the errors, the response is Blame the Vendor:

“Claims are more appropriately brought against the software manufacturer.”

[Which could likely have a "hold harmless" agreement with the hospital - ed.]

This is reminiscent of the hemming and hawing in the aforementioned cases linked at the beginning of this post, and leads me to conclude many hospitals are, through legal games and technicalities, burying their mistakes with little accountability.

[Of course, the hemming and hawing nets defense attorneys probably $400+ per hour of the hospital's money ... - ed.]

I submit that if after Medicare finds hospitals to have not met applicable professionally recognized standards of health care resulting in patient injury, yet the hospitals profess they “cannot determine plaintiff’s claims”, seek to pass blame to vendors of medical devices that may have contributed to harm, and other legerdemain, then … those hospitals needs to find themselves new medical and Board-level leadership.

This is especially true when experts have forewarned them about medical device deficiencies that could result in patient harm.

– SS

Let’s spend tens or even better, hundreds of billions of dollars more on experimental healthcare IT.

(It worked out so well for the UK’s NPfIT, we should follow the NHS’s example of how to wisely spend our crucial healthcare billions.)

I will comment no further:

Wall Street Journal Health Blog
October 5, 2011, 10:00 AM ET
Public-Health Services Get Crunched by Budget Woes
By Betsy McKay

Immunizations, emergency preparations for hurricanes, and restaurant inspections are among local public-health services being cut back or eliminated amid budget constraints.

Some 55% of the nations county and city health departments reduced or eliminated at least one program between July 2010 and June 2011, and the public-health workforce continued to shrink, according to a new survey by the National Association of County and City Health Officials.

The cuts hit maternal and child health services (at 21% of the departments reporting cuts), personal health services (20%), emergency preparedness (20%), chronic disease screenings (17%), and food safety (11%), among other programs.

Health departments lost 5,400 jobs in the first half of this year, after losing 6,000 in all of 2010. There are currently about 120,600 local health department employees across the country after those cutbacks. While the workforce has been shrinking since 2008, the downsizing is now eating into program capacity, says Robert Pestronk, NACCHOs executive director.

Particularly worrying are the cutbacks in emergency-preparedness programs, he says. Its troublesome given what were seeing in terms of weather conditions and threats in communities, he tells the Health Blog. Health-department employees help plan for emergencies such as hurricanes, make sure supplies are in place and work as responders.

Meantime, cutbacks in immunization programs are making it harder for some children to get needed polio, tetanus and other preventive vaccinations, while reductions in food-safety programs mean fewer restaurant inspections or staff to interview people sickened in a food-borne illness outbreak, Pestronk says.

These woes arent limited to local health departments. The Centers for Disease Control and Prevention has seen its budget for preparedness and response fall by more than $350 million since 2005, to about $832 million in fiscal 2011. That challenges the CDCs ability to respond to a pandemic like the type featured in the recent bio-thriller Contagion, Rear Admiral Ali Khan, the CDCs chief of public health preparedness and response, told the Health Blog at a screening of the film.

Also see my March 2010 post “Hospitals Under the Knife: Sacrificing Hospital Jobs for the Extravagance of Healthcare IT?” where I observed:

… In effect, NY hospital physicians, nurses and support staff will lose their job due to budget shortfalls, at the same time the NY hospitals have been spending hundreds of millions of dollars on the extravagance of experimental clinical IT systems whose benefit is still an unknown.

Perhaps some of those millions could have been better spent on human beings, such as employees or better yet, patient care.

– SS