Medical transcription outsourcing: Who actually does the work?

Knowing who actually does the outsourced medical transcription work is very important because of the very sensitive and critical nature of the work. Making sure that the company chosen for outsourcing, executes the medical transcription work themselves, and not through subcontractors or home transcriptionists is very important. This has benefits like:

· Better control
Having to deal with one entity that does the work makes it easier to control all the processes. Otherwise it could result in dilution of control

· Data security
Data Security is one of the most important factors to be considered before engaging the services of an outsourced transcription vendor. Getting work done through a series of subcontractors and home-based transcriptionists would mean that patient data is exposed to various networks and computers.

The more number of people and networks handling this information the higher is the security risk.

When outsourcing to a zero-subcontracting company like TransDyne, the data is handled professionally. TransDyne employs the best data security practices like high –end encryption, firewalls and foolproof access control measures

· Consistent Quality of work
When a company engages subcontractors, it has no control over who does the work and how. With a service provider like TransDyne there is more consistency in the quality of work as it is done by the same team of people who handle the same set of providers on a regular basis

· Personalized services
Any personalized needs of the healthcare facility like formats etc can be easily changed/added whenever required and the smallest preferences of each individual dictator are taken care of.

· Better understanding of special needs
When subcontractors work on dictations, they treat the work as a commodity, as a job that needs to be finished with the least amount of resources.

With a company like TransDyne any special needs of the healthcare facility are taken care of as TransDyne has complete control over the entire transcription process and their people are trained to take care of each client’s special needs.

· Better rates
By eliminating the need for the sub-contractor a company like TransDyne will be in a position to offer much better rates for superior service.

· Better customer service
One to one communication means less scope for misunderstanding and this translates into better customer service.

· Zero legal hassles
Due to the sensitivity of the data involved, it is important to keep it secure. Data access to more people can result in legal hassles due to misuse. Getting work done by a zero subcontracting company like TransDyne would mean zero legal hassles.

· Better turnaround time
When home transcriptionists or sub contractors are involved there are a lot of delays due to various factors like power outage, poor connectivity etc. These delays are avoided when the medical transcription service provider does the transcription in-house and turnaround time commitments are met with.

At TransDyne it is believed that it is their privilege to be serving their customers’ needs in the best way possible. So any work outsourced to TransDyne, is executed by their own team of trained medical transcriptionists, than by the use of subcontractors or home transcriptionists.

The healthcare facility benefits by virtue of TransDyne’s vast experience, their training methods, best practices, and the comfort of absolute confidentiality & data security.

To avail medical transcription services form TransDyne, click here

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CEO Summit at the Governor's HIT Conference

On most Thursdays, I write about something personal. However, this week is filled with special HIT events convened by Massachusetts Governor Deval Patrick.

Today, the Governor's Healthcare IT Conference began with a panel of CEOs from Humedica, Patientkeeper, Vecna, eCW, Microsoft, Intersystems, Concordant, Biscom, Bessemer Ventures, Life Image, EMC, NaviNet, Navigator Ventures, Meditech, and T2Bio.

Here's a summary of their comments

*The uncertainty in meaningful use and standards caused a delay in sales for 6 months, followed by record sales once hospitals and eligible professionals felt confident about their purchases

*Qualified staff is getting harder to find. Over the next few years, there is likely to be a competition for trained healthcare IT professional, similar to the Dot Com era. The states can really help by adding additional resources to community colleges for staff development as we prepare for 50,000 new HIT jobs.

*Medicaid programs and private insurers can accelerate adoption of HIT by aligning incentives. For example, if states and private insurers adopted meaningful use criteria, we could reduce healthcare costs by eliminating redundant testing.

*Massachusetts CEOs emphasized the need for affordable housing and transportation investments so that staff living in lower cost areas can commute to corporate locations.

*Standards, especially a consistent way to transmit clinical data from place to place are enablers.

*Loan programs for clinicians will aid investment today to achieve meaningful use stimulus payments in the future

*Health Information Exchange is a Greatest Good for the Greatest Number activity. State Governments need to provide leadership to ensure the stakeholders in each region are aligned with a single project plan, a single set of transaction priorities, and all the enablers such as regional infrastructure to accelerate adoption of data exchange.

*Regulatory barriers such as variation in privacy laws need state and federal government action to enable data liquidity. For example, revisions in the clinical laboratory improvement act (CLIA) and e-prescribing for controlled substances are already in process.

The afternoon of the conference included a great keynote by David Blumenthal outlining everything ONC has done thus far.

All that remains in the current grant program is the announcement of Beacon Communities, which he said will occur very soon.

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My Thanks to HITSP

Today I wrote this email to all HITSP members thanking them for all their service from October 2005 to the present.

-------------

Folks:

Today is a milestone day. The HITSP Contract extension expires but our work will live on as a foundation to meaningful use, standards and certification.

It is my hope that all of us will continue to be part of the ONC processes, providing input to the Federal Advisory Committees, staffing workgroups, and implementing interoperability solutions in our communities.

The HITSP website, containing all the HITSP documents, will continue to be available. ANSI has graciously offered to maintain the website for the next few months until contracts are awarded and other arrangements are made.

The new RFPs have not yet been awarded and we'll continue to watch for those announcements.

What's new in the heatlhcare standards world this month?

The April HIT Standards Committee focused on vocabulary standards, consumer engagement and healthcare reform transactions.

NHIN Direct continued its work to define simple transport implementation guides and addressing specifications.

We'll see the revised Interim Final Rule on Standards and the Notice of Proposed Rulemaking on Meaningful Use before Summer.

A busy time for all as we implement all the standards and interoperability we've all worked so hard to define.

Thank you for all you do and I look forward to seeing you in Washington as we continue our work in a new ONC framework that leverages everything HITSP has accomplished.

John

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Food Allergy Message from Trace Adkins

Country music star, Trace Adkins, has posted a public service announcement on YouTube. While it doesn't give much new information to those of us food allergy veterans, it is a fun to link to share with friends and family.

Check it out and pass it on!

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Medical Transcription services

What is transcription and how does it relate to the field of medicine?
Transcription is conversion of audio files to typed records in a paper form or in the form of computer files as per specified formats. Medical transcription is the conversion of audio files of a patient encounter as dictated by a healthcare professional into a typed version, which is then stored in the form of paper records or as a computer file.

Why is medical transcription needed?
Records of patient encounter need to be created and maintained for various reasons such as patient treatment, permanent patient records, referrals to other doctors, evidence in case of malpractice suits, coding, billing and insurance claims and satisfaction of regulatory norms. Medical transcription plays a vital role in creating accurate records of patient encounters with the doctors.

How is medical transcription done?
After the patient encounter, the healthcare professional dictates notes regarding the encounter into a recording device of his choice, which is then transcribed by a person skilled in this kind of work having knowledge of medicine, latest drugs, procedures and good language skills.

When is medical transcription done?
Once the doctor has finished dictating notes these are then transmitted to the medical transcriptionist using various means, the actual transcription is finished within a period of 24 hours at the latest. Priority is given to STAT files and these are returned earlier.

Who does the medical transcription?
Medical transcription is done by in-house medical transcriptionists or through outsourcing to a medical transcription service provider who specializes in this kind of work.

It has been argued that doctors could themselves create records as and when they finish with the patient encounter. But this has been proven to curb the productivity of doctors in terms of time spent typing (which is not necessarily their core skill) and reducing the time spent on care of patients.

Why outsource medical transcription?
Outsourcing medical transcription can benefit a healthcare facility in various ways. If helps them to focus on healthcare which is their core business rather than medical transcription which is not. It also improves profitability by freeing up valuable resources like manpower, capital and time etc which would otherwise be focused on medical transcription.

Having understood the importance of medical transcription and the benefits of outsourcing, one needs to choose a medical transcription service provider that excels on the following criteria:

Accuracy: This means the percentage of accuracy of the completed transcripts vis-à-vis what was dictated. A minimum of 99% and above would be acceptable.

Turnaround time: Turnaround time refers to the time taken to revert the transcribed report to the healthcare facility. A Turnaround time of not more than 24 hours for normal reports and 4-12 hours for STAT reports would be considered ideal.

Data security: The company being outsourced to should be HIPAA/HITECH compliant. The medical transcription service provider has to have adequate security measures to ensure that the confidential data transmitted back and forth is safe and secure.

Pricing: Saving on costs is one of the main benefits that a healthcare facility hopes to have, from the outsourcing option. Pricing should be fair and reasonable for the services rendered. Pricing method should also be transparent and simple so that both parties can verify the same at any stage of the process

Technology: The technology used by the service provider should not only be secure but should also be easy to use, without having to require extensive training.

TransDyne offers quality medical transcription at reasonable prices, done by expert medical transcriptionists with a very quick turnaround time executed through secure HIPAA and HITECH compliant channels, with very high levels of accuracy and all this with technology that is advanced but easy to use!

To avail TransDyne’s superior medical transcription services, click here.

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Investigations, Indictments and Guilty Pleas at Famous US Teaching Hospitals

Some of the US most prestigious academic medical centers have been receiving unusual scrutiny lately.

Mount Sinai Medical Center and New York - Presbyterian Hospital.

As reported first by the Wall Street Journal,

Federal prosecutors are investigating allegations that bid rigging and fraud at Mount Sinai Medical Center and New York-Presbyterian Hospital resulted in the hospitals awarding contracts worth tens of millions of dollars to outside contractors.

Purchasing officials at the hospitals, two of the city's largest and most prestigious, are alleged to have gotten more than a million dollars in payments from companies that were then given lucrative contracts to perform work such as re-insulating pipes and removing asbestos, according to documents filed in the Southern District of New York.

Nine contractors are involved in the case. So far, eight people and three companies supplying the hospitals have pleaded guilty to charges including bid-rigging, mail fraud and tax fraud. Three more people have been indicted on similar charges.

The Federal Bureau of Investigation and Internal Revenue Service have been investigating and the Justice Department's Antitrust Division is prosecuting the allegations in the case.

Some relevant specifics:

The most recent indictment, handed up by a federal grand jury April 6, involved the alleged awarding of more than $195,000 in maintenance and insulation contracts. Mario Perciavalle, associate director of plant services at Mount Sinai, is accused of taking at least $20,500 in cash from a Long Island City company in 2004 and 2005 in exchange for the company, unnamed in documents, winning the deals.

Prosecutors also are pursuing a case involving a former official at New York-Presbyterian, Salvatore Scotto-DiVetta, a supervisor at the hospital's Facilities Operations department. He pleaded guilty in March to rigging bids for re-insulation contracts, the Department of Justice said.

The next day, the Journal reported:

Two New York-Presbyterian Hospital officials and two contractors who did business with the prestigious hospital were indicted on fraud charges Tuesday in the latest cases stemming from a federal investigation into bid-rigging and fraud.

The indictment alleges that the hospital officials�Santo Saglimbeni of Armonk, N.Y., and Emilio Figueroa, whose hometown wasn't given�received payments and gifts in exchange for awarding contracts to certain companies.

And already the box score for this investigation increased:

As a result of the investigation, a total of five hospital employees, 10 people outside the hospitals and six companies have either pleaded guilty or face charges.

The comments by hospital officials had a familiar ring to anyone who has been following the hearings in Washington on the global financial collapse. From the first article:

A Mount Sinai spokesman said the hospital notified the Justice Department 'about the possibility of impropriety immediately after it was identified in an internal audit' and is cooperating with the investigation. The spokesman said the hospital dismissed the employee under investigation and instituted tougher contracting systems.

From the second:

New York-Presbyterian was an 'unknowing victim of these alleged crimes,' a hospital spokeswoman said. She also said that the staffers named in the indictment no longer work at the hospital, and it is cooperating with the investigation.

Partners Healthcare System

Just out today in the Boston Globe:

The US Department of Justice has opened a civil investigation into possible anticompetitive behavior by Partners HealthCare System Inc., the region�s most powerful hospital and physician network.

In a letter sent to Partners and the state�s three largest health insurers on April 19, investigators from the Justice Department�s antitrust division demanded documents relating to Partners� 'contracting and other practices in health care markets in Eastern Massachusetts.'

The letter, obtained by the Globe, said the probe sought to determine whether the practices violated the Sherman Antitrust Act, which bars companies from using their market power to limit trade or artificially raise prices.

The background is:

Boston-based Partners has been under growing scrutiny because of its market power and ability to draw high prices from insurers. The company employs about 5,500 physicians and operates a half dozen smaller hospitals, in addition to their prestigious Harvard-affiliated Boston teaching hospitals, Mass. General and the Brigham.

Earlier this year, Attorney General Martha Coakley issued a report documenting that Massachusetts insurance companies pay some hospitals and doctors, including those in the Partners network, twice as much money as others for essentially the same patient care. The report pointed to the market clout of the best-paid providers as a main driver of the state�s spiraling health care costs.

A 2008 Globe Spotlight Team series focused on the Boston market found that hospitals such as Mass. General and the Brigham typically are paid 15 to 60 percent more for essentially the same work as other hospitals.

Soon after that series, Coakley launched her investigation into whether Partners and Blue Cross-Blue Shield, the state�s largest health insurer, may have illegally colluded to increase the price of health insurance statewide over the last decade, according to several legal and government sources.

And again, the official response had a familiarly evasive ring:

Partners spokesman Rich Copp yesterday noted that the hospital network already has supplied similar information to investigators from the state attorney general�s office, which launched its own review of Partners� contracting practices last year. He noted in Partners� defense that it vies with other providers in the area�s 'highly competitive' health care market.

'The Department of Justice has requested the same information that we have provided to the attorney general�s office,' said Copp. 'We will continue to cooperate with both government agencies during this ongoing analysis of health care in Massachusetts.'

Summary

So there it is.  Multiple indictments for and guilty pleas to charges of bid-rigging and fraud at two New York academic medical centers, and state collusion and federal anti-trust investigations of a Massachusetts hospital system.  The issues involve four of the most prestigious teaching hospitals in the US.

Of course, not all the indictments may result in convictions, and the investigations may not result in charges.  But this involves some institutions that at one time would have appeared beyond reproach.  The lack of clear denials from the inevitable official spokespeople, and attempts to deny responsibility for the actions of employees elsewhere identified as "officials" do not provide much reassurance.

Of course, readers of Health Care Renewal would have known that questions could be raised about leadership and governance of these once-revered institutions.  Questions could be raised about the incentives implied by the huge compensation given to the top hired executives at New York - Presbyterian, awarded by a board of trustees that includes some of the leaders of the more prominent failed finance corporations involved in the global financial collapse.  Questions could be raised about the dominant presence of finance leaders and possibly conflicted individuals on the Partners board, and apparent interlocks among Partners leadership and the leadership of the largest health insurer in Massachusetts, which was willing to pay that system so much.

Maybe, instead of lecturing the more lowly among us about our responsibilities to improve health care, the leaders of our previously most august health care institutions need to introspect more about their own responsibility to address the metastasis of "greed and incompetence" in health care from the financial sector.

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The April HIT Standards Committee Meeting

The April HIT Standards Committee today had a rich agenda and very active discussion.

We began with an update from the Implementation Workgroup and their desire to make toolkits, accelerators, and best practices available via the web. They'll align their efforts with the Tools and Standards Repository RFP described in my earlier blog.

We next discussed healthcare reform and its requirements for comprehensive insurance plan enrollment standards support as written in SEC. 3021. HEALTH INFORMATION TECHNOLOGY ENROLLMENT STANDARDS AND PROTOCOLS.

"Not later than 180 days after the date of enactment of this title, the Secretary, in consultation with the HIT Policy Committee and the HIT Standards Committee, shall develop interoperable and secure standards and protocols that facilitate enrollment of individuals in Federal and State health and human services programs, as determined by the Secretary."

As David Blumenthal described it, the intent of this provision is to make signing up for insurance as easy as using an ATM card. All the supportive transactions including identity documentation, eligibility checking, and matching identity among diverse databases needs to be specified over the next 6 months. To do this, it is clear that the Policy and Standards Committees will need to work together. Doug Fridsma and ONC was charged with recommending a process, a structure, and a framework for us to do this work.

Dixie Baker and Steve Findlay updated us on consent standards and the suite of consumer focused domain standards. The industry is asking for more specificity in the patient engagement portions of meaningful use - when producing an electronic copy of a health record, what should be included? What fields are required for an outpatient summary? The HIT Standards Committee working with ONC has more work to do in this area.

Janet Corrigan and Floyd Eisenberg described the ongoing efforts by the Quality workgroup to retool existing metrics to be EHR friendly and their project to catalog existing electronic quality measures already in use.

After lunch, Jamie Ferguson outlined two recommendations of the Vocabulary Task Force. The need for a single government office or agency to coordinate vocabulary subsets/codesets and the need to make them available via "one stop shopping" in a single repository. The committee endorsed these recommendations and they were forwarded to ONC.

Arien Malec and Doug Fridsma presented an update on the NHIN Direct effort and its short timeline to produce reference implementation. NEHEN will work to connect Massachusetts with other states as a demonstration of the NHIN Direct protocols. The HIT Standards Committee agreed that we need to coordinate all the privacy/security efforts of the HIT Policy Committee, HIT Standards Committee, NHIN Connect, and NHIN Direct efforts to ensure consistency.

Finally, Jodi Daniel from ONC and Michelle Ferritto from the Drug Enforcement Administration/Office of Diversion Control presented all the requirements for e-Prescribing controlled substances. Identity proofing is key to reducing fraud, so two factor authentication is required. Audit trails are required. Certification of software is required. e-Prescribing of controlled substances is not required as part of meaningful use at this point, but it is likely clinicians will want to do it so that they have the same workflows for prescribing Lipitor (a non-controlled substance) as Valium (a controlled substance).

The work ahead for the next few months will include

Content standards - administrative transactions such as enrollment and claims attachments in support of healthcare reform

Vocabulary standards - all the subsets/codesets required for meaningful use

Transmission standards - supporting the NHIN Direct effort

Privacy/Security - continuing our work on consent standards and the specificity needed for patient engagement

All of this will be done in the context of evolving harmonization frameworks which are supported by new RFPs.

I look forward to the work ahead!

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Judge Rejects Prosecutors' Lenient Settlement of the Case of the Hidden Defibrillator Defects

We just discussed the proposed settlement of a case in which the Guidant subsidiary of Boston Scientific was alleged to have withheld information about defects in its implantable cardiac defibrillators that were associated with six patient deaths (see next most recent post here with more complete summary).  The devices were manufactured in 2000-02, and the issue first became public in 2005.  The proposed settlement included a seemingly large fine for the company. 

Now the New York Times has reported that the presiding judge has rejected the settlement as too lenient.

A federal judge in Minnesota on Tuesday rejected a plea agreement between the federal government and the Guidant Corporation, saying that the deal did not hold the company sufficiently accountable for an episode in which it sold potentially flawed heart defibrillators.

The ruling was a setback for the Justice Department, which had characterized the agreement as a demonstration of its get-tough approach to corporate crime. The deal called on Guidant to plead guilty to two misdemeanors and pay a $296 million fine, described as the largest by a medical device company.

But in his opinion, the judge, Donovan W. Frank of United States District Court said the provisions of the agreement were 'not in the best interest of justice and do not serve the public�s interest because they do not adequately address Guidant�s history and the criminal conduct at issue.'

The story brought several peculiar aspects of the settlement to light.

- The settlement seemed to ignore the most egregious misconduct alleged:

Recently, prosecutors charged in court papers that Guidant had knowingly sold potentially flawed defibrillators. But that issue was not addressed in the plea agreement. Instead, the company agreed to plead guilty to two misdemeanor charges that related to the completeness and accuracy of its filings with the Food and Drug Administration.

- It was not really the Guidant subsidiary that was going to plead guilty, but a new entity apparently constructed solely to "take the rap."

The company created to enter Guidant�s plea, Guidant LLC, existed only on paper.

In his ruling, Judge Frank took direct aim at that argument, suggesting it contradicted the Justice Department�s own public statements about the case. He noted that a department news release said Guidant�s plea deal was 'about accountability.'

Judge Frank wrote, 'The interests of justice are not served by allowing a company to avoid probation simply by changing their corporate form.'

So, the judge demanded that at least the company be put on probation, and possibly be required to do some good works:

Judge Frank said that prosecutors should have sought probation for Guidant and its parent, Boston Scientific. Probation would have required the companies to take certain steps, like helping to rebuild public confidence in the safety of heart devices, in addition to paying a fine.

The judge also outlined other provisions that might be suitable in a new plea deal, including charitable activities by Guidant to improve heart device safety and improve medical care among minority patients.

Daniel R. Margolis, a lawyer in New York who works on medical product cases, said that probation is effectively a way for a court to maintain some control over a company�s activities after it pays a financial penalty.

However, the judge felt he could not require prosecution of the actual people who authorized, directed, or implemented the misbehavior at issue.

After a hearing this month, several doctors and patients wrote to Judge Frank urging him to reject the deal and arguing that former Guidant executives should be criminally charged in the case. But Judge Frank noted in his ruling that it was up to prosecutors, not a court, to decide who should be prosecuted.

We have discussed a series of settlements and convictions resolving cases of alleged wrong-doing by health care organizations.  Almost none included any penalties for people who authorized, directed or implemented the bad behavior.  None of the financial penalties were so big as to be more than another cost of doing business for the organizations involved.  Some of the cases included gimmicks, like a subsidiary constructed only to plead guilty, that otherwise seemed to lessen accountability. 

Despite the US Justice Department's assertion of a new "get-tough" approach, this new settlement did not seem like any more of a deterrent to bad behavior than the parade of settlements that cam before, that is, until Judge Frank acted. 

We applaud the judge for trying to hold at least one large health care organization accountable for its misdeeds.  However, I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health.

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Pondering Leadership

This blog often talks about the failure of leaders in health care. The April, 2010, issue of Harvard Business Review boasts an entire "Spotlight" Section on this subject.

Perhaps the two most interesting articles in this section, both by big names--Atul Gawande and Tom Lee--among today's medical chattering classes, are entitled, respectively, "Health care needs a new kind of hero," and "Turning doctors into leaders." The first, an interview, first touts the good doctor's vaunted emphasis on checklists, then goes on to plead for improved training in team-play: "we don't train physicians how to lead teams or be team members."

The second, by Dr. Lee, is more substantive. The network president of Boston's Partners Healthcare System and CEO of Partners Community HealthCare, formed quite a while back by Brigham and Women's and MGH joining forces, Lee makes a longer version of the same argument which boils down, essentially to, "docs need to learn to play nice."

He starts with the plea we've heard so often before, it sounds like elevator music:

The problem with health care is people like me�doctors (mostly men) in our fifties and beyond, who learned medicine when it was more art and less finance. We were taught to go to the hospital before dawn, stay until our patients were stable, focus on the needs of each patient before us, and not worry about costs. We were taught to review every test result with our own eyes�to depend on no one. The only way to ensure quality was to adopt high personal standards for ourselves and then meet them. Now, at many health care institutions and practices, we are in charge. And that�s a problem, because health care today needs a fundamentally different approach�and a new breed of leaders.

Seems unexceptionable, as far as it goes. Maybe I'm just a crank who preceded Dr. Lee at his alma mater by, oh, say, a decade or so, but I'm feeling just a wee bit brassed off at hearing, yet again, Pogo's same tired old "we have met the enemy and he is us" plaint. Here it is, from Dr. Lee himself:

The usual suspects have surprisingly small roles. Greed and incompetence surely exist, but economists agree that they don�t account for double-digit annual cost increases on their own.

Oh really? So let me see here, what we really need is more folks like Tom Lee, folks who are willing to apply "Tough Medicine" and understand that "Performance Matters." A whiff of the self-serving here. Being "tough" here means being a good measurement wonk, holding doctors to "results" standards.

While one could never wholly disagree with this sentiment, or conviction, or whatever it is, what's missing is the big picture. For starters, the problem of executives with purely technocratic solutions.

Which is partly why, in this observer's humble view, we continue to have this "anechoic effect." That's the one critics of the larger defects in the health care system don't just get drowned out by technocratic Pogo-talk. They really aren't much heard at all.

The defects include rotten information technology, corrupt hospital and insurance leaders, and insurance companies cocky enough to crow, eleven days after HR 4872, and now quoting Secretary Sebelius, they're "allowed to insure a child, but exclude treatments for that child�s pre-existing condition."

Why don't the self-professed next-gen leaders ever talk about this stuff? A recent New York Times op-ed piece suggested one answer. I read it and slapped my forehead, "of caws!"

Adam Cohen, the author, is describing why the Cassandras--hey, there are a few of those in this blog, eh wot?--don't get heard. Why they disappear into the anechoic chamber. In this case, on the topic of the 2008-2009 meltdown in the broader economy.

Incompetence often plays a role. So does ideology: one reason [Federal Reserve governor Edward] Gramlich, a Democratic nominee, was ignored was that his warnings clashed with the antiregulatory convictions of the Bush administration. In other cases, to borrow Al Gore�s phrase, an �inconvenient truth� imposes burdens that people don�t want or threatens powerful interests.

Cassandras warning about the Catholic Church's abuses, about Bernie Madoff, about 9-11: you can find 'em all. But Cohen's is not a rant. It's a reasoned explanation of why warnings don't get listened to.

So here are a couple warnings. Neither Tom Lee-style technocratic "let's pull up our socks" answers, nor HR 4872, get anywhere near solving the problems that continue to plague this country's bloated health care system. Primary care continues to circle the drain. Health care leaders continue to line their own pockets, basically betting against the system's ability to sustain this percentage of the GDP [this blog, passim].

I guess it's just the old dance. Leaders in lofty positions in Harvard organizations learn to measure their words and advance their own "be like me" agendas, while the Cassandras sit out there in the blogosphere and thump their chests.

But wouldn't it be grand if just occasionally, the Tom Lees of the world grew some cojones and really stood up to those who're milking our system for everything it's worth? Or are they too busy managing their own conflicts of interest and sweetheart deals?

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Oh, the Prices We Pay, Reloaded - Celgene Balks at Explaining High Price of Thalidomide

A brief article on Bloomberg.com implied that Celgene has been fighting efforts by the Canadian Patented Medicine Prices Review Board to get pricing data about the drug Thalidomid (thalidomide):

Celgene Corp., the biotechnology company specializing in blood-cancer medicines, will get a hearing before Canada�s highest court over the country�s demands to provide pricing information for the drug Thalomid.

The Supreme Court of Canada today agreed to hear Celgene�s appeal of a Federal Court of Appeal ruling that said Canada�s Patented Medicine Prices Review Board was entitled to information about the pricing of the drug. The high court gave no reason for its decision.

Celgene�s two top-selling drugs are Revlimid and Thalomid, for a form of blood-cancer called multiple myeloma. They brought in more than 80 percent of the company�s total $2.25 billion in 2008 revenue.

It should be no surprise that Celgene may be sensitive about the price of Thalidomid. We posted back in 2005 about the stratospheric prices of new drugs that seemed disproportionate to manufacturing and development costs on one hand, and the value of the drugs for patients on the other. We noted that thalidomide, a very old drug that notoriously was found to cause birth defects when it was given to pregnant women, but that then showed promise as an anti-cancer drug, was being marketed in the US for $29 per capsule (approximately $25,000 a year), while a generic form sold in Brazil for $0.07 per capsule.
 
The amount Celgene manages to make from this very old (and demonstrably cheap to produce) molecule is vivid, albeit anecdotal evidence about what has gone wrong with health care prices in the US.  Despite health care insurance companies' protestations that their goal is to provide reasonably priced health care, they seem utterly incapable of negotiating down the prices of even the most obviously over-priced drugs.  And the US government Medicare program so far is prohibited by law from negotiating prices.  How our supposed free market health care system has tilted so far in favor of pharmaceuticals is a reason to wonder, but ought to be reason to investigate. 
 
Meanwhile, Celgene's 2010 annual report shows that the company has sold more than $400 million worth of Thalidomid yearly since 2007. The company's total sales in 2009 were $2.567 billion, while it spent $795 million on research and development, and $754 million on general, sales, and administrative expenses. According to the company's 2009 proxy statement, in 2008 its CEO received over $8.5 million, its COO over $5.1 million, its CFO over $2.1 million in compensation, and a senior vice president over $3.0 million. The total compensation of its five highest-paid hired managers (compare to a total of 2813 full-time employees in 2009), approximately $20.5 million 2008, was was approximately 2.6% of the company's net income in 2009, and just under 1% of its total sales.
 
As we have said previously, so the health care bubble continues to inflate.  One cause is"compensation madness," including "insiders hijacking established institutions for their personal benefit."  Another is the amazing acquiescence of those who pay bills at all levels, from the individuals who ultimately fund health care through salary dollars not earned, health insurance premiums, co-pays and the like, and tax payments, through the health care insurers and government agencies who did not balk at paying $25,000 a year for thalidomide in 2005.  If we really want to provide accessible health care of good quality and a reasonable cost, we will need to develop mechanisms to pay more reasonable amounts for health care goods and services. This will require some courage facing down the corporate and organizational insiders who have made themselves very rich from the current craziness.

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Food Allergy and EpiPens

So, a new study shows that an increased number of us are accidentally poking ourselves with epinephrine auto-injectors. Well, at least teenagers are. The study, with data from 1994-2007, didn't give information about the circumstances of these accidents.

I suspect that as more people carry and use auto-injectors, we'll see more accidents.

The recommendation is improved design of the auto-injector and better training. EpiPen® has a new design. Have you seen it yet? It does seem to be easier to hold. When this new one expires, I'll try it out in an orange- taking great care not to inject myself!

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The Genomes, Environments and Traits Conference

This morning, I'll be on stage with all the humans who have had their genomes sequenced - James Watson (pictured above), Henry Louis Gates, Misha Angrist, John West, Jay Flatley, Greg Lucier, Seong-Jim Kim, Rosalynn Gill, George Church, and James Lupski.

The GET Conference 2010 marks the last chance in history to collect everyone with a personal genome sequence on the same stage to share their experiences and discuss the important ways in which personal genomes will affect all of our lives in the coming years.

From 9a-12p, we'll discuss our personal experiences with sequencing and its impact on our lives, families, medical care, and policy thinking.

At noon we'll gather for a photograph of all the sequenced humans. By 2011 the number of individuals with personal genome sequences will rise dramatically, from a dozen today to hundreds, and possibly thousands. This makes tomorrow's photograph the last opportunity to have us all together.

I'll publish the photo on my blog as soon as it is available.

A few interesting items from the conference

In April 1953, Watson and Crick published their article characterizing DNA

In April 2003 the first Human Genome sequence was completed

In April 2008 the genetic non-discrimination act (GINA) was published

The cost of a complete human sequence in 2000 was $3 billion

The cost of a sequence 2004-2007 was $70 million

The cost of sequence in 2008 was $50,000

The cost of a sequence in 2010 is $1500

This is Moore's law on steroids. No one in the industry can believe the amazing drop in sequencing costs over the past decade.

My sequence is in the public domain and my stem cells are available online for $85.00.

I'm Coriell subject 21070.

The next addition to my online public data is a functional MRI map of my brain. I completed the scans over the weekend and I'll post an overview soon.

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The Governor's Healthcare IT Conference

Although healthcare reform has its supporters and detractors, healthcare IT reform - the use of technology to improve the quality, safety and efficiency of healthcare throughout the country - has broad support from all stakeholders.

The passage of last year�s $787 billion economic stimulus bill brought with it a healthcare IT modernization program that could inject about $30 billion into the economy. Since Massachusetts is a leader both in the use and the manufacturing of healthcare IT systems, this could translate into over a $1 billion for the Commonwealth of Massachusetts.

This isn�t a �cash for computers� program though � it�s much more than that. The stimulus bill was crafted very wisely. It�s not a field day either for the doctors and hospitals who would receive these funds, or for the vendors selling this hardware and software. That�s because in order to get these dollars, physicians and hospitals have to not only buy the new systems, they have to prove that they�re using them to improve care before they�ll qualify to get any money back from the government. What does it mean to improve care? The requirements are actually quite specific and include: improving care coordination, reducing healthcare disparities, engaging patients and their families, improving population and public health, and ensuring adequate privacy and security protections.

The health IT modernization program promotes the use of advanced tools which could significantly improve the quality and efficiency of healthcare in the country today. Massachusetts is well positioned to lead this charge.

The genius of the program is that it is carefully tailored to fit our uniquely American economy and culture. We are a society that prizes individual initiative and rejects �top-down� solutions, and no other part of the economy is more reflective of that than health care delivery. We also believe in the power of markets to allocate resources where they�ll create the most value and to drive innovation that improves peoples� lives. So unlike other countries where the government is creating its own infrastructure and dictating which systems the medical community must use, the Obama Administration�s health IT program uses federal dollars to give an adrenaline boost to the market.

It does this in three ways: incentives to providers who use IT to achieve higher quality, lower cost care; non-proprietary strict standards to create a level playing field for users and sellers of software and hardware systems; unbiased certification of software to provider assurance that it meets basic quality, safety, and efficiency standards.

Incentives. Medicare and Medicaid have defined 25 basic projects that each hospital and clinician office must complete to demonstrate that they have embraced technology to improve care. For example, medications must be electronically ordered, checked for safety, and routed to pharmacies - going from the clinician's brain to the patient's vein without paper or error-prone handwriting. Massachusetts is already the #1 electronic prescriber in the country and has been for the past 3 years. Even so, less than one-third of all prescriptions in the Commonwealth are transmitted electronically today. Fortunately, all of our regional health plans have been champions of e-prescribing, as have all of our major provider groups. Multi-stakeholder partnerships such as the New England Healthcare Institute, Massachusetts Health Data Consortium, and Massachusetts eHealth Collaborative have focused on medication safety. So even though we�re ahead of the pack, we still have a long way to go. The federal health IT program will provide a valuable boost to all of these efforts.

Standards. Well-defined precise electronic formats are needed to share data in our communities with patient consent. For more than a decade, Massachusetts has been a leading state in the secure exchange of patient data via the New England Healthcare Exchange Network (NEHEN), SafeHealth, Community Hospitals and Physician Practice Systems (CHAPS) and the Northern Berkshire eHealth Collaborative sponsored by the Massachusetts eHealth Collaborative. Massachusetts is also a national leader in providing patient access to their medical records through such programs as PatientSite, PatientGateway, myHealth Online, and Indivo Health and providers and health plans making their data available to GoogleHealth and Microsoft HealthVault.

Certification. Medical software, like any other technology that directly impacts public safety, must conform to basic testing and certification to ensure it has the capabilities needed to improve quality, safety and efficiency in hospitals and offices.

Incentives to physicians and hospitals adds fuel to the health care delivery sector, which is one of the engines of the Massachusetts economy. Furthermore, incentives to purchase software and hardware will draw dollars from other parts of the country because Massachusetts is home to several leading vendors of electronic record products such as eClinicalWorks in Westborough, AthenaHealth in Watertown, and Meditech in Westwood.

In addition to direct stimulus payments to hospitals and providers, our state has already garnered millions of dollars in grants to establish core infrastructure to spur the market. The Massachusetts eHealth Institute, a subsidiary of the quasi-governmental Massachusetts Technology Collaborative, has received almost $25 million to accelerate healthcare information exchange and facilitate electronic health record rollout. Harvard Medical School received $15 million for advanced research in electronic health records. Our academic, government, and industry experts will continue to compete successfully for additional grants as they become available.

On April 29 and 30, Governor Deval Patrick will host the Health Information Technology: Creating Jobs, Reducing Costs and Improving Quality Conference. HHS Secretary Sebelius, National Healthcare IT Coordinator David Blumenthal, and many governors will attend. It will offer us a remarkable opportunity to showcase the strength of our healthcare technology accomplishments in Massachusetts, and to learn from leaders from other parts of the country.

For all we've accomplished, there is much to do.

We still have silos of information locked away in hospitals, offices, pharmacies, and labs. We still have redundant and unnecessary testing because our care is uncoordinated. We're still using a huge amount of paper in our healthcare facilities. Paper kills.

How?

My grandmother's life was cut short by medical error. She was prescribed a combination of medications that should never be given to an older person. She developed stomach bleeding, a sudden drop in blood pressure, a stroke, and ultimately died as a result of it.

With electronic health records, data sharing, and decision support rules that inform clinicians about best practices for personalized medical care, she would have avoided harm.

Massachusetts has been an intellectual, economic, and political leader for healthcare IT for decades. We're now at the tipping point with the funding, momentum, and opportunity to ensure every patient has an electronic health record. The work ahead to complete the transformation of our manual workflows and data silos into a coordinated electronic healthcare system will be hard. Politicians, payers, providers, and patients must work together to make it happen over the next 5 years.

The lives of our grandmothers depend on it.

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Food Allergy Friendly Baseball

It's baseball season again (Go Phillies!) and I need to give a shout out to Jennifer over at Food Allergy Buzz. She also writes Free to Enjoy Baseball, which is a listing of baseball teams and games that have made special accommodations for those with peanut and other food allergy.

So make plans this spring or summer to take in a game- safely. If your team doesn't offer food allergy friendly games, contact them through their website and ask them to consider it. If you hear of any special games, shoot the info over to Jennifer (e-mail: jennifer@foodallergybuzz.com)so she can list it on her site for everyone's benefit.

Time to play ball!!!!

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BLOGSCAN: CMSS New Ethics Code Analyzed

The Council of Medical Specialty Societies got some good press for its new code of ethics regarding medical associations' interaction with industry.  Two of the best skeptical bloggers about health care dissected the code, suggesting it will not be as tough as it was cracked up to be.  See these posts by Dr Daniel Carlat on the Carlat Psychiatry Blog and by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

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Explaining Health Care Executives' Impunity - the (Unexplained) Leniency of Prosecutors

On Health Care Renewal, we noted many legal settlements and criminal convictions in cases alleging unethical behavior by health care organizations.  Some organizations have settled, and/or pleaded guilty, and/or been convicted numerous times.  And we have said repeatedly, (e.g., here) such legal actions will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Relatively small fines imposed on large corporations pain workers on the line and stockholders while sparing the richly paid top hired management and the boards that will not reign them in.

A recent article in the New York Times about a plea agreement in a case in which the Guidant subsidiary of Boston Scientific was alleged to have withheld information about defects in its implantable cardiac defibrillators that were associated with six patient deaths (see most recent post here) throws some light onto the apparent impunity of top health care leaders.  The article reiterated:

In recent years, the Justice Department has won hundreds of millions of dollars in fines from drug and device makers, including a string of cases in which the companies have pleaded guilty to violating federal laws.

But corporate executives rarely face criminal charges in such actions....

The article noted:

�Prosecutors want the money,� said Mr. Fleder, of Hyman, Phelps & McNamara. �And at least in the big money settlements they have had in pharma cases, it appears that prosecutors are willing to settle even if it means forgoing prosecutions against individuals.�

Yet, as we have said,

Short of executives facing prosecution, companies see the hefty financial settlements demanded by the Justice Department as another price of doing business, industry critics say.

There does not seem to be a legal barrier to holding these executives accountable:

... they can be held liable under federal law for regulatory violations that occur on their watch � whether or not prosecutors can prove the executives participated in the wrongdoing or even knew about it.

But if this is so, why have corporate leaders not faced such penalties before? An experienced prosecutor explained it at one level:

A former prosecutor in many drug and medical device-related cases, Michael K. Loucks, said he never charged corporate executives with misdemeanors � which apply in cases when the violations are deemed unintentional � because he believed that being barred from the industry was too harsh a consequence.


�I think that if you are going to take actions that take away someone�s liberty or livelihood, you should have to prove felony conduct,� said Mr. Loucks, who spent over 20 years as an assistant United States attorney in Boston.

This ends up as a very disturbing response. Professionals who hold positions of trust in society, most particularly health care professionals, can lose their livelihood for unprofessional conduct or unethical actions that are not felonies, or even criminal. In health care (and in some other fields, like law), professionals are held to a higher standard that merely avoiding conviction for felonies. (For examples, peruse the lists of doctors and other health care professionals whose licenses were suspended or revoked by state medical boards.)

In our current world of commercialized health care, leaders of large health care organizations can take actions that have as important consequences for peoples' health and safety as the individual actions of doctors and nurses. Why should they not be at risk of the loss of their current livelihood for actions that risk peoples' health and safety?

I do not know why an experienced prosecutor felt that health care executives deserved so much more leniency than health care professionals may receive from medical boards. Maybe in the future we will begin to hold those who authorized or directed unethical actions that risk health and safety accountable.

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Pay for Hypocrisy for Health Insurance Executives

A few weeks ago, we discussed the cognitive dissonance produced by huge salary boosts for top executives of health care companies with miserable ethical track records.  One of our examples contrasted a long list of ethical violations by US giant health insurance company/ managed care organization WellPoint and the huge raises given its CEO and top executives.  Now more ethical questions are being raised about WellPoint.

Rate Hikes Retrospectively for Golden Parachutes

An op-ed published in several California newspapers (here via the Sonoma Index-Tribune) claimed that the huge rate hike that WellPoint's California subsidiary proposed earlier this year, an action that helped to revitalize the US legislative health care reform process, was meant to recoup costs of a previous merger that the company had agreed not impose on its policy-holders:

Nobody at Anthem Blue Cross, the firm that's now a poster boy for out-of-control health insurance premiums, likes remembering the company's days of high anxiety back in 2004, when California's then-Insurance Commissioner John Garamendi was holding up its $18 billion deal to take over Thousand Oaks-based WellPoint and its California Blue Cross subsidiary.

A frequent resister of insurance rate increases, he at least wanted to make sure Anthem didn't pass along the inflated price it paid for WellPoint to Blue Cross customers.

So he refused for months to sign off on the merger, a form of passive resistance that threatened to hold up the entire deal, which also involved WellPoint insurance subsidiaries in other states.

...in the process, he achieved some things for California consumers: Anthem formally agreed to forego any rate increases for Blue Cross customers to cover the costs of the merger, which increased more than $2 billion during the delay as WellPoint shares rose from $91 to $113 between the day the deal was announced and the day it went through. The company also promised to invest $200 million over 10 years in under-served communities through California's Healthy Families program, plus another $15 million on children's insurance programs and $50 million for training nurses and operating clinics in California.

It wasn't as good as keeping California Blue Cross a California company, but at least it was something.

'Was' now appears likely to be the operative word, because there is no way the cost of medical tests, doctor and hospital fees and medical supplies has risen 39 percent in one year, a claim made by Anthem executives while testifying before Congress and state legislative committees.

Nope, it's now clear that, even if Anthem doesn't admit it, a good part of its rate increase would go to replenish corporate cash spent on the WellPoint takeover.

It's been just over five years since that deal was completed, with Anthem adopting the WellPoint name for its parent company, much as North Carolina-based NationsBank renamed itself Bank of America after taking over the B of A. The Anthem tag was then hung on California Blue Cross.

That's enough time so the corporation can conveniently maintain it has lived up to its written commitment not to make customers pay for its high-priced acquisition - while in reality making them do just that.

For certain, the huge price increases Anthem may now assess violate the spirit of its agreement with Garamendi, even if they might not violate the letter of that deal.

Note that this article did not make explicit what  "costs of the merger" Mr Garamendi did not want policy-holders to pay for.  As contemporaneous coverage of the negotiations by USAToday made clear, these included golden parachutes for some of the executives involved.

Commissioner John Garamendi was the last major stumbling block to the $16.4 billion deal, delaying the merger of a piece of the company, Blue Cross Life & Health, over which he had jurisdiction. His main concerns were costs to policyholders and the size of executives' golden parachutes, estimated at $200 million to $600 million.

WellPoint CEO Leonard Schaeffer alone is expected to get a package worth $53.5 million in cash, stock options and pension payments when the deal is completed.

Now, of course, it appears that the policy-holders are being called upon to retrospectively reimburse the company for the outrageous amounts it gave to executives back then, who may turn out to have been the biggest beneficiaries of the merger.

Turning Administrative into Patient Care Costs

Then, an article in the Washington Post reported how WellPoint was reclassifying administrative costs as patient care costs to fulfill an upcoming requiement of health care reform to spend at least 80 percent of premiums on health care.

The idea was simple enough: Make sure that health insurers spend the vast majority of their revenue on patient care, instead of using it for things such as advertising, profits and executive pay.

To that end, the new health-care law says an insurer must give money back to consumers if it devotes less than 80 percent of premiums to paying medical claims and improving care. For insurers serving large groups, the target is 85 percent.

But even before the health-care overhaul was signed into law last month, one of the nation's largest insurance companies reclassified certain expenses in a way that increased its so-called medical-loss ratio. In January, WellPoint began including under medical benefits such costs as nurse hotlines, 'medical management,' and 'clinical health policy,' a WellPoint executive said in a March briefing for investors.

To be clear, while it may be that "nurse hotlines" actually involve care for patients, it is hard to fathom what "medical management" by an insurance company means.  Certainly, "clinical health policy" is not direct patient care.

Targeting Breast Cancer Patients for Insurance Policy Cancellation

At least the above two cases were only about money. The third case affects patient care.

A Reuters report showed how WellPoint deliberately targeted every patient who developed breast cancer for a fraud investigation, often resulting in findings of minor irregularities in insurance applications that the company used as pretexts to retroactively cancel the patients' policies. Many of these patients then could not get needed cancer care.

...WellPoint was using a computer algorithm that automatically targeted them and every other policyholder recently diagnosed with breast cancer. The software triggered an immediate fraud investigation, as the company searched for some pretext to drop their policies, according to government regulators and investigators.

Once the women were singled out, they say, the insurer then canceled their policies based on either erroneous or flimsy information. WellPoint declined to comment on the women's specific cases without a signed waiver from them, citing privacy laws.

That tens of thousands of Americans lost their health insurance shortly after being diagnosed with life-threatening, expensive medical conditions has been well documented by law enforcement agencies, state regulators and a congressional committee. Insurance companies have used the practice, known as 'rescission,' for years. And a congressional committee last year said WellPoint was one of the worst offenders.

But WellPoint also has specifically targeted women with breast cancer for aggressive investigation with the intent to cancel their policies, federal investigators told Reuters.

Not only did this seem heartless and unethical, it demonstrated the hypocrisy of WellPoint's leadership.

The revelation is especially striking for a company whose CEO and president, Angela Braly, has earned plaudits for how her company improved the medical care and treatment of other policyholders with breast cancer.

Specifically,

Singling out women with breast cancer for aggressive investigation with the intent of canceling their insurance stands in stark contrast not only to the public image WellPoint cultivates for itself but also to the good work it does for many other policyholders with breast cancer.

WellPoint CEO Braly has taken a strong personal interest in women's health issues. Foremost among them is how to increase services to people with breast cancer.

The company prides itself on being one of the United States' largest corporations with women at the helm. Besides Braly, two high-powered, politically connected women sit on WellPoint's board: Susan Bayh, the wife of retiring Democratic Sen. Evan Bayh of Indiana, and Sheila Burke, who was chief of staff to former Senate Republican leader Bob Dole.

On Braly's initiative, WellPoint has funded groundbreaking studies about the disparities in quality of health care to minority women -- including women with breast cancer.

WellPoint has worked to encourage mammography for at-risk women. Personalized letters -- followed up by phone calls -- are sent to more than 80,000 women between the ages of 52 and 69 if they have not had a mammogram in the past year. The company conducts automated calls for women ages 40 to 69 to make sure they are getting mammograms.

Once diagnosed, WellPoint has set up an 'Breast Cancer Resource Center' for its policyholders to help them 'navigate the complex health care system.'

And in May 2009, WellPoint's charitable foundation, the WellPoint Foundation LLC, provided a grant for the American Cancer Society for its 'Hope Lodges,' which allow cancer patients and family members free lodging and support while receiving care far from home.

The only explanation provided in the article for this behavior was that politically correct concerns about womens' health issues only go so far, money is more important.

Why would WellPoint on the one hand work to improve health care for women with breast cancer while automatically investigating every single woman diagnosed with breast cancer for possible cancellation of their policies?

Karen L. Pollitz, a research professor at the Health Policy Institute at Georgetown University, offers one possible explanation: 'It is important for these companies' profit margins that they get rid of policyholders with expensive diseases,' she said.

I would add also that these profit margins provide the excuses for baronial compensation for the company's top executives. 

Parenthetically, the article also noted that WellPoint had lobbied against provisions in the health care reform bill that might have threatened its ability to retrospectively cancel insurance policies after their holders got sick:

Many critics worry the new law will not lead to an end of these practices. Some state and federal regulators -- as well as investigators, congressional staffers and academic experts -- say the health care legislation lacks teeth, at least in terms of enforcement or regulatory powers to either stop or even substantially reduce rescission.

'People have this idea that someone is going to flip a switch and rescission and other bad insurance practices are going to end,' says Peter Harbage, a former health care adviser to the Clinton administration. 'Insurers will find ways to undermine the protections in the new law, just as they did with the old law. Enforcement is the key.'

During the recent legislative process for the reform law, however, lobbyists for WellPoint and other top insurance companies successfully fought proposed provisions of the legislation. In particular, they complained about rules that would have made it more difficult for the companies to fairly -- or unfairly -- cancel policyholders.

For example, an early version of the health care bill passed by the House of Representatives would have created a Federal Office of Health Insurance Oversight to monitor and regulate insurance practices like rescission. WellPoint lobbyists pressed for the proposed agency to not be included in the final bill signed into law by the president.

They also helped quash proposed provisions that would have required a third party review of its or any other insurance company's decision to cancel a customer's policy.

Furthermore, an article on the Huffington Post noted that a former WellPoint executive seems to have written a good part of the health care reform legislation:

As Marcy Wheeler reported last year, the Senate Finance Committee bill was written by former WellPoint VP Liz Fowler, who left her position at the insurance company in February 2009 expressly for the purpose of helping the committee to draft the health care bill.

And when Max Baucus did a 'victory lap' after the health care bil passed, he expressly thanked Fowler for her work:

'I wish to single out one person, and that one person is sitting next to me. Her name is Liz Fowler. Liz Fowler is my chief health counsel. Liz Fowler has put my health care team together. Liz Fowler worked for me many years ago, left for the private sector, and then came back when she realized she could be there at the creation of health care reform because she wanted that to be, in a certain sense, her profession lifetime goal. She put together the White Paper last November-2008-the 87-page document which became the basis, the foundation, the blueprint from which almost all health care measures in all bills on both sides of the aisle came.'

Summary

To make this more personal than these posts usually are, I wonder how WellPoint CEO Angela Braly sleeps in whatever luxurious accomodations her eight-figure compensation affords her?  I wonder how all the other current and former WellPoint leaders who styled themselves great proponents of "womens' health issues" can live with putting profits ahead of the care of breast cancer patients?

Adding this latest list of ethical offenses to those we discussed earlier, WellPoint is beating out the heavy corporate competition as an example of the hypocrisy produced by putting imperial CEOs and their trusty hench-people ahead of every other consideration.  It has also become a premier example of how self-interested leadership can raise costs, decrease access, and degrade clinical care.  It further shows how compensating health care leaders to the point where they become imperial also grants them the power to fend off most threats to their power.  (Consider what health care reform might have become if it were orchestrated by people really interested in improving care, controlling costs, and increasing access, rather than by imperial CEOs who just wanted to become more imperial.) 

If we truly want health care that is accessible, of high quality, at a fair price, and more importantly, if we want health care that is honest and focused on patients, we need to provide health care leaders with clear, rational incentives in these directions, and make them fully accountable for their actions, and the courses of their organizations under their leadership.

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Cool Technology of the Week

While touring colleges this week, I was impressed by the focus on green technologies at many institutions. Many have LEED certified buildings, extensive recycling programs and innovative alternative energy sources.

I was most intrigued by Middlebury's commitment to be carbon neutral by 2016. A major component of that effort is their Biomass gasification facility pictured above, my cool technology of the week.

The idea is simple. Biomass is fuel derived from plants, such as trees, grass, soybeans and corn. Middlebury's plant uses a highly efficient gasification process in which wood chips are super-heated in an oxygen deprived environment, where they smolder creating gasses that are ignited to heat the boiler, which produces steam. The filters in the biomass facility are rated to remove 99.7 % of the particulates from the exhaust. Overall the emissions produced by the biomass plant are not greater than those that result from Number 6 fuel oil. Burning wood produce ssignificantly less emission of sulfur compounds, which contribute to acid rain.

Benefits include

*40% reduction in net emissions of carbon (12,500 metric tons)

*eliminates 1 million gallons of Number 6 fuel oil

*utilizes a local, renewable resource

*education of students and the public about energy use

*research into new fuel sources, such as willows that local farmers can grow on marginal lands

*support for locally manufactured green technology

*stimulation of the local and state economy

*less dependence on foreign oil

Additionally, the biomass plant uses the excess pressure from the steam to co-generate approximately 3-5 million kilowatt-hours of electricity per year. Also, the heat from the exhaust is used to preheat water going into the boiler.

A renewal, carbon neutral, co-generation plant - that's cool!

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Cookie Contest Winner

For all you cookie lovers out there, a new allergy friendly cookie will soon be on the market. Congratulations to Elizabeth Ilson of Tarpon Springs, Florida with her Double Chocolate Brownie Bites. The contest was co-sponsored by FAAN and Divvies.

Here's the full press release.

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Smoke Screen - How a Conflict of Interest Muddled the Debate on the Smoke-Free Initiative at the University of Michigan

As a physician, not being a big fan of cigarette smoking, I would have found little to criticize had anyone showed me the Smoke-Free Initiative at the University of Michigan, as promoted by the University President, Mary Sue Coleman. 

A Conflict of Interest: University President and Johnson & Johnson Board Member

It turns out, though, that this initative has provoked debate on that campus, not so much about its possible benefits and harms, but about whether the Ms Coleman's promotion of it had to do with a conflict of interest.  The debate broke out with an op-ed in the Michigan Daily:

It�s clear, then, that University President Mary Sue Coleman is the architect of the Smoke-Free Initiative, which will take effect in July of 2011. The initiative will prohibit smoking on all outdoor University property. Coleman and University administrators have been embarrassingly vague about why such a ban is necessary. Instead, they keep insisting that the smoking ban will improve public health.

Interestingly enough, the smoking ban may also improve Coleman�s salary.

That�s because Coleman isn�t just a college president. In her spare time, she moonlights as a businesswoman, sitting on the board of directors for major pharmaceutical company Johnson &  Johnson, as well as the Meredith Corporation, a magazine publisher. According to Forbes.com, her position at Johnson & Johnson netted her an income of $229,000 last year.

Among Johnson & Johnson�s many marketed brands are smoking cessation products like Nicorette and Nicoderm � products that University smokers will feel encouraged to use once smoking becomes unwelcome on campus in July 2011. Indeed, administrators have already announced that smoking cessation products may be offered at discounted prices to students who are trying to quit.

Obviously, this is a sizeable conflict of interest for Coleman. Even if her Johnson & Johnson salary didn�t actively influence her decision to ban smoking, it makes it substantially harder to take her at her word that the University needs this ban � especially when representatives of her administration can�t come up with a specific reason for it.

But Coleman�s corporate troubles run deeper than this. As the University�s College Libertarians pointed out in a press release this weekend, Johnson & Johnson has an affiliated non-profit group, the Robert Wood Johnson Foundation, which lobbies for the adoption of certain health-related policies through research and grant money. RWJF is notoriously anti-smoking, as its website explains: 'At the state and community level, we support advocacy for proven tobacco control measures, such as smoke-free air laws, funding of prevention and cessation programs and increases in tobacco taxes.'

While it�s no surprise that RWJF would fight for laws that restrict smoking and lead to increased use of Johnson & Johnson products, such an aggressive lobbying force should not hold financial sway over the president of a public university. Students, faculty and staff must be able to trust that their president is working in the best interests of the University community, not a profit-motivated corporation. Even the perception of a conflict of interest is embarrassing for this institution.

And then, in another op-ed in that paper:

Granted, some of Coleman�s reasons for the Smoke-Free Initiative are likely motivated by good intentions like lowering the University�s health care costs. But these justifications are severely compromised by her compensation from a corporation that will likely benefit from the smoking ban. Coleman sits on the board of directors for Johnson & Johnson, from which she earned nearly a quarter of a million dollars in 2009, and holds 11,159 shares of common stock, 10,777 shares of common stock equivalent units and 7,600 exercisable stock options in the company. Johnson & Johnson is the producer of a host of nicotine replacement products, including Nicoderm and Nicorette. Coleman explains, 'the University will offer free behavioral sessions and selected over-the-counter smoking cessation products to faculty and staff, along with co-pay reductions for prescription tobacco cessation medicines (and) discounts on tobacco cessation aids.'

In other words, under the proposed Smoke-Free Initiative, the University would subsidize products made by Johnson & Johnson. The University would purchase more nicotine replacement products, likely resulting in financial gains for Johnson & Johnson and, consequently, Coleman.

In reply, a letter by Dr Robert W Winfield, University of Michigan Chief Health Officer, asserted:

Some have raised concern about the appearance of a conflict of interest between President Coleman�s service on the board of directors of Johnson & Johnson, a company that produces some smoking-cessation products.

Simply put, there is no conflict. Prescription-only drugs for smoking cessation are generally considered the most effective and most widely used. Johnson & Johnson does not make any prescription-only smoking-cessation products.

A report of a meeting of the Michigan Student Association noted:

In a press release and columns in The Michigan Daily, members of the College Libertarians have identified Coleman as having an apparent conflict of interest due to her position on the board of Johnson & Johnson � a company that manufactures and markets smoking cessation products.

Kozack said if the allegations prove to be true, they could have large implications as Coleman is compensated for sitting on the company�s board.

He said the main reason for the resolution and the accusation of Coleman�s conflict of interest is that there is not enough information provided to the whole campus about the origin of the Smoke Free Initiative.

But in defense of President Coleman, the following appeared in the Michigan Capitol Confidential:

The University of Michigan's student newspaper - The Michigan Daily - wrote an opinion piece last week suggesting a conflict of interest involving University of Michigan President Mary Sue Coleman.

Coleman also earned a $230,000 salary in 2009 for sitting on the board of Johnson & Johnson. Alza Corporation, a subsidiary of Johnson & Johnson, markets Nicorette and Nicoderm, smoking cessation products.

Three ethics experts say Coleman is not in conflict.

'She is doing a public health service,' Peter Rost, a former vice president of Pfizer who has testified before Congress on the business practices of drug companies, wrote in an e-mail. 'The possible income by J& J from this campus is completely and utterly negligible and will have no impact on J&J income statement. Same thing if she opened public health clinic for depressed students and happened to sit on board of (a company) selling antidepressants. Conflict of interest should normally have some undue influence on either party. Since that is not the case I'm not troubled.'

Aine Donovan, the executive director of the Ethics Institute at Dartmouth College who teaches business ethics, said she didn't see a conflict.

'This is very reasonable,' Donovan said. 'Johnson & Johnson has a large range of products. This is a very reasonable position she is taking and it is a very laudable one.'

Timothy Keane, director of the Emerson Ethics Center in St. Louis, said it was 'a bit of a stretch' to say Coleman had a conflict of interest.

'Johnson & Johnson is not trying to set up shop and sell something to the University,' Keane said. 'They are not being a supplier to the University. It doesn't matter if you are a smoker or not, research indicates it is bad for you.'

A Hazy Debate

Smoke gets in your eyes. Maybe it should not be a surprise that once President Coleman's relationship with Johnson and Johnson was noted, opponents and proponents of the Smoke-Free Initative used arguments about that relationship to bolster their positions, rather than debating the smoking ban on its merits. The result, however, shows how conflicts of interest seem to always produce confusion, if not smoke and mirrors.

Most of the debate seemed to be about whether Ms Coleman would personally profit from the smoking ban, and if so, how much. For example, the second op-ed above argued, "the University would purchase more nicotine replacement products, likely resulting in financial gains for Johnson & Johnson, and consequently, Coleman." On the other hand, one expert quoted in the Michigan Capital Confidential argued that the income to J&J from the Michigan campus would be "utterly negligible," and another argued that "Johnson & Johnson is not trying to set up shop and sell something to the University."

On one hand, however much use of J&J nicotine replacement products there is at the University of Michigan, the amount is unlikely to change the profits of J&J, or the salaries or values of stock owned by its directors. On the other hand, J&J may not run a retail store at the University, but it is in the company's interest to sell more of all its products on university campuses, and everywhere else.

But in my humble opinion, the issue is not about the degree President Coleman's salary and assets derived from her position with Johnson and Johnson would be affected by a specific policy she may advocate. The issue is whether her judgments and decisions as President could be unduly influenced by her relationship with the company.

Definition of Conflicts of Interest


This provides a good opportunity to review a good working definition of conflict of interest as it applies to medicine, health care and health policy. Last year the Institute of Medicine published a thorough and well-balanced report, Conflict of Interest in Medical Research, Education, and Practice. It defined conflict of interest (p. 6):

Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest. Primary interests include promoting and protecting the integrity of research, the quality of medical education, and the welfare of patients. Secondary interests include not only financial interests....

Furthermore,

The severity of a conflict of interest depends on (1) the likelihood that professional decisions made under the relevant circumstances would be unduly influenced by a secondary interest, and (2) the seriousness of the harm or wrong that could result from such an influence.

But,

a judgment that someone has a conflict of interest does not imply that the person is unethical. Such judgments assume only that some situations are generally recognized to pose an unacceptable risk that decisions may be unduly infuenced by considerations that should be irrelevant.

Thus, a conflict of interest should be seen as a situation which increases the risk of bad judgments or decisions, but does not necessarily cause them, much less cause a particular bad judgment or decision.  (Thus, it makes no sense to try to argue, as the experts did above, that because a person made a good decision, he or she does not have a conflict of interest.)

I assert that President Coleman has a conflict of interest. Her primary interests as President of a university are to uphold the university's academic mission, and as President of a university that includes a medical school, a school of public health, and an academic medical center, also to uphold the integrity of patient care and public health practice. Her secondary interest as a member of the board of directors of a public, for-profit corporation is her fiduciary duty to that corporation and its stockholders, which means she must "demonstrate unyielding loyalty to the company's shareholders" [Per Monks RAG, Minow N. Corporate Governance, 3rd edition. Malden, MA: Blackwell Publishing, 2004. P.200.] Such unyielding loyalty to the shareholders of a pharmaceutical and medical device company clearly creates a risk of influencing judgments or actions that could affect the corporations' sales or operations, economic or health policy, or the general environment in which it operates.  Many of the judgments of or actions performed by  the leader of a medical school, public health school, and academic medical center could so so, and are thus at risk of being so unduly influenced.

However, that she has such a conflict does not prove that any particular judgments or decisions were made badly because of it. Conversely, that particular judgments or decisions were made well does not disprove the existence of the conflict. 

So I beg to differ with all the experts cited in the Michigan Capital Confidential article.  On the other hand, while the President may have a conflict of interest, it is impossible to tell how or whether this influenced her particular decision to support the Smoke-Free Initiative.  Neither does it speak to the benefits or harms of such a policy.  The main effect of the President's conflict of interest seems to have been to muddle the debate about the policy.

Conflicts of interests' general tendency to muddle and confuse provide one argument for their elimination.  Another is that they may affect judgments and actions that are not so readily debated as, and more likely to produce bad results than smoke-free initiatives.  Maybe the hazy debate about the University of Michigan Smoke-Free Initiative will lead to a clearer discussion of whether academic and academic medical leaders should also be corporate leaders.

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