Thursday, July 31, 2008

Health Worker's Religious Freedom, Patient Rights, and Ethical Deliberation

Today's Washington Post article about a budding Bush administration proposal to extend the rights of health care workers to opt out of participation in a range of procedures that they object to was all over the blogosphere within minutes of publication.

The proposal, which would deny federal funding to any hospital, clinic, health plan or other entity that does not accommodate employees who want to opt out of participating in care that runs counter to their personal convictions, including providing birth-control pills, IUDs and the Plan B emergency contraceptive, is an obvious effort to heat up the abortion debate. Opponents of abortion say the regulations are needed. Supporters of choice see it as another effort to thwart access to legal care options.

Quite apart from the torch the regulations would toss into the abortion debate, they construe society as composed of individuals who look inward to conscience with no need to engage with others. They embody no sense of a moral community that must deliberate and struggle with difficult questions and develop creative ways of living with differences. In a similar vein, observers of the legislative process comment on the trend towards polarization without deliberation, accomodation, and compromise.

This moral solipsism is a major impediment to guiding our health "system" towards better quality and more sustainable costs. Our default moral reflex is that every physician has a "right to autonomy" and every patient has a "right to the treatment he wants." When these moral reflexes are applied to insurance systems they result in the runaway costs and suboptimal quality we see today. When they are applied to individuals they result in ever wider disparities of access and outcomes.

With skillful leadership, communities have shown that they can come to grips with potentially explosive ethical issues. The Oregon Death with Dignity Act shows how over the course of several years a state developed a viable approach to a deeply divisive question. (Read about it here.) The Century Foundation effort to make Medicare a demonstration project for collaborative oversight of health policy reflects the same vision.

Wednesday, July 30, 2008

Joint Replacement, Medicare, and the Ethics of Arrogance

Our national failure to establish a registry to track the performance of artificial joints points to a little discussed value that drags down the quality and efficiency of U.S. health care – self-satisfied arrogance.

The trigger for this posting is the latest article in a New York Times series on the “evidence gap” – treatments purveyed in the absence of persuasive evidence that they work.

Here’s the story. Artificial joints are made by different companies. The devices vary in their performance. Some do better with one patient group and worse with another. New devices are introduced with hope and hoopla. Eight years ago 3,000 patients received a hip implant that caused terrible pain for many before it was removed from the market. (It turned out that the implant had been contaminated by oil during production. In the face of enormous claims, the company filed for bankruptcy.)

This would not have happened in Australia, Britain, Norway, or Sweden, which track the performance of implanted joints. Perhaps 40 – 50 would have received the new joint before its failure was identified. Not 3,000.

The idea of systematically tracking the performance of new kids on the block in medicine is a no-brainer. There is everything to say for it, and little against it other than the effort it takes to do the right thing.

So what’s going on here? Are we too stupid to see the obvious?

The problem isn’t stupidity – it’s arrogance. How often have we all heard that we have the best health care in the world? American exceptionalism – the belief that we are different, and better, than all others, and have nothing to learn from them, runs deeply in our national soul. With artificial joints, arrogance shows up in our assumption that the claims of U.S. companies about their products must be true, and that the opinion of an individual surgeon is an adequate monitoring system.

Our absurdly fragmented health “system” makes creation of a registry more difficult. Organizations like Kaiser Permanente can track their own experience. But the most obvious venue for initiating the registry process is Medicare.

That's the most distressing part of the story. The U.S. performs half of the world’s joint replacements, and Medicare pays for half of the implants. But two years ago Medicare turned down a proposal to create a registry, with the rationale that it was not the agency’s job to collect the data.

Medicare’s response to the registry proposal reflects the same stifling potential of bureaucracies that was at work when the Federal Office for Human Research Protections initially squashed wider application of the ICU checklist program (read about it here).

Conflict of interest obviously plays a large part in our failure to monitor the performance of our health care non-system. There is so much money to be made by manufacturers, hospitals, and practitioners. Careful scrutiny of results could block the income flow.

But conflicts of interest are omnipresent. If we didn’t start from a stance of arrogance – the smug conviction our health "system" is the BEST – we would confront the conflicting interests and seek out the facts.

"Evidence-based medicine" is a popular slogan. But it won't have meaning in action as long as we remain wedded to our near delusional belief in the excellence of our health care "system."

I think the most practical suggestion as to what we should do is found in Maggie Mahar's recent "Health Beat" posting on Medicare. Jeremiads against arrogance don't create change. But we can all see the writing on the Medicare wall - without reform, this most popular national program will go broke. Mahar urges Congress to make Medicare a demonstration program for effectiveness and efficiency. Doing this could be framed as a piece of responsible bipartisan governing. It doesn't require a national mea culpa about arrogance. Once we make collecting information about effectiveness and safety a routine expectation in health care our value set may shift from arrogant faith to empiricism.

Monday, July 28, 2008

Involving Consumers in Research and Evaluation

An article about “Client Involvement in Public Administration Research and Evaluation” by my friends Rick Beinecke (Department of Public Management, Suffolk University) and Jon Delman (Executive Director, Consumer Quality Initiatives), makes a strong case for involving consumers in the research on/evaluation of public programs.

I think their argument is spot-on.

I’ve seen how consumer involvement can contribute to research/evaluation in mental health. Clinicians focus on variables like adherence to medication and utilization of professional services. Consumers focus on variables like housing, employment, and, most broadly, a meaningful life. Research and evaluation need both perspectives.

The Beinecke/Delman article introduced me to a set of eight “Principles and Indicators of Successful Consumer Involvement in the [British National Health Service]" that I hadn’t seen before. It is easy for professionals to mouth off about the value of consumer involvement and for consumer advocates to demand “respect” and “empowerment.” The NHS principles and indicators tell us how the rhetoric about consumer participation can be put into action on the ground. (In the list that follows, the indicators follow the principles as bullets):

1. The roles of consumers are agreed between the researchers and consumers involved in the research.
• The roles of consumers in the research were documented.

2. Researchers budget appropriately for the costs of consumer involvement in research.
• Researchers applied for funding to involve consumers in the research.
• Consumers were reimbursed for their travel costs.
• Consumers were reimbursed for their indirect costs (e.g. carer costs).

3. Researchers respect the differing skills, knowledge and experience of consumers.
• The contribution of consumers’ skills, knowledge and experience was included in research reports and papers.

4. Consumers are offered training and personal support, to enable them to be involved in research.
• Consumers’ training needs related to their involvement in the research were agreed between consumers and researchers.
• Consumers had access to training to facilitate their involvement in the research.
• Mentors were available to provide personal and technical support to consumers.

5. Researchers ensure that they have the necessary skills to involve consumers in the research process.
• Researchers ensured that their own training needs were met in relation to involving consumers in the research.

6. Consumers are involved in decisions about how participants are both recruited and kept informed about the progress of the research.
• Consumers gave advice to researchers on how to recruit participants to the research.
• Consumers gave advice to researchers on how to keep participants informed about the progress of the research.

7. Consumer involvement is described in research reports.
• The involvement of consumers in the research reports and publications was acknowledged.
• Details were given in the research reports and publications of how consumers were involved in the research process.

8. Research findings are available to consumers, in formats and in language they can easily understand.
• Research findings were disseminated to consumers involved in the research in appropriate formats (e.g. large print, translations, audio, Braille).
• The distribution of the research findings to relevant consumer groups was in appropriate formats and easily understandable language.
• Consumers involved in the research gave their advice on the choice of methods used to distribute the research findings.

Several years ago, Norman Daniels and I did a series of articles about “Strengthening the Consumer Voice in Managed Care.” If you’re interested in reading more about consumer involvement, you may find the article about the Philadelphia Consumer Satisfaction Team worth reading about.

Sunday, July 27, 2008

Conflict of Interest in the American Psychiatric Association

Today I experienced the impact of conflict of interest on trust first hand. Sadly, it involves the professional society I have belonged to for 40 years - the American Psychaitric Association (APA).

The July 18 issue of the APA newspaper "Psychiatric News" has a column about conflict of interest and transparency by APA president Nada Stotland. Dr. Stotland comments that "for reasons that are unclear, much of the [media] attention [to conflict of interest in medicine] has focused on psychiatrists and APA..."

Sadly, the reasons are all too clear. Psychiatry has become so strongly biologically oriented that the profession is in danger of losing the respect it has earned as the most humane of specialties. We have experienced recurrent backtracking on the safety and efficacy of psychiatric medications. The degree to which the pharmaceutical industry supports the APA (30% of revenues) and individual leaders in the field has been widely publicized.

Dr. Stotland's column acknowledges the danger that that "the receipt of money or gifts causes our patients and the public to question our professional integrity - and [potentially] undermines the credibility of everything we do." She cites APA policies about disclosure of commercial relationships and the limits set on Pharma income ($10,000) for participants on key committees, and concludes "I believe we are doing what we can..."

A story on the next page in "Psychiatric News" described an APA resolution presented to the AMA House of Delegates asking for reexamination of the FDA criteria for approving generic medications for bio-equivalence. In her testimony at the AMA Dr. Stotland acknowledged "that at a time when organized medicine is under public scrutiny regarding ties to the pharmaceutical industry, a resolution raising questions about the clinical efficacy of some generics would raise skepticism in some quarters."

I admire Dr. Stotland and I love the APA, but my own reaction was just what she predicted for "some quarters." If loyal 40 year members of the APA feel something between queasiness and shame on the issue, imagine the reaction of those with less trust in the Association and its leadership!

The corrosive impact of conflicts of interest occur not only through actual distortions of judgment, but also through loss of trust in individuals and groups. The APA is at severe risk for losing trust. The problem will only get worse, given the intense scrutiny of the incoming APA president's relationship to a pharmaceutical company. (See, for example, a series of postings on the Health Care Renewal blog.)

Even if our confidence in our own integrity is 100% warranted, we can't expect even the most fair-minded persons to rest easy if it is disclosed that we have stock holdings worth millions in a company whose drug we are studying. (This is what appears to be the case for the incoming APA president.) And if 30% of our budget comes from the manufacturers of branded medications, who is going to trust that our questioning of the bio-equivalence of generics - however justified it might be - rests on scientific and clinical concerns alone?

As I was writing this posting, Bob Dylan's "The Times they are A-Changin" started playing in my mind:
Come gather 'round people
Wherever you roam
And admit that the waters
Around you have grown
And accept it that soon
You'll be drenched to the bone.
If your time to you
Is worth savin'
Then you better start swimmin'
Or you'll sink like a stone
For the times they are a-changin'.
I don't see any easy answers to the quandary the APA is in. But the status quo with a sprinkling of disclosure will not sustain the trust my profession needs. With regard to the relationship between medicine and the industries that produce pharmaceuticals and devices, the times are definitely changing!

Thursday, July 24, 2008

Deliberating about Hard Choices in Massachusetts

All societies must set limits on health care. But how can they do it in a clinically informed, ethically justifiable, and politically acceptable manner?

In “Setting Limits Fairly,” Norman Daniels and I argued that pluralistic societies lack shared principles by which resource allocation and limit setting decisions could be made. We concluded that a fair process is required. Deliberation that considers individual needs, population needs, and medical facts is at the heart of that process.

A deliberative process that considers the relevant reasons for and against policies will not yield answers that everyone likes. But if we know that our positions have been listened to, we are likelier to find decisions acceptable, even if disappointing.

In societies with universal coverage and national or regional budgets (essentially all developed countries except for the U.S.) deliberation typically takes place in government bodies and public commissions. Often the national parliament oversees and signs off on the process.

But how on earth could “deliberation” take place in the fragmented U.S. public/private health system? The Massachusetts health care reform process is struggling with that question right now.

The Massachusetts program is based on a concept of shared responsibility. Individuals who are deemed capable of affording insurance are required to purchase it or pay a penalty on their state taxes. Health plans are asked to offer less costly programs. Employers with 11 or more employees who do not offer insurance pay a penalty into the insurance fund. Government contributes substantially. (Providers, uniquely, have no explicit expectations placed on them.)

Massachusetts is making excellent progress in reducing its uninsured population. But the program is costing more than predicted. That’s where the rubber meets the road in terms of shared responsibility. Who decides how to handle the cost problem? How does it get decided?

Legislatures are imperfect structures, but debating, deliberating, and deciding are their basic function. In Massachusetts, the Connector Board, which I will write more about in the future, is the entity that oversees the reform process. Minutes and the materials for its monthly meetings are posted on its website.

What currently stands out for me in Massachusetts is the way print media and the blogosphere are providing a public space for deliberation. The central meeting ground is the Commonhealth blog, hosted by WBUR, a public radio station. I don’t know how many hits it gets, but the blog is read widely by a broad swath of politically concerned citizens – not just policy wonks.

The Commonhealth blog is a virtual form of the Athenian agora. A wide range of civic, political, industry and policy leaders speak their mind, at enough length to get beyond slogans and sound bites. In recent weeks Reverend Hurmon Hamilton, President, Greater Boston Interfaith Organization, made a powerful moral appeal for shared responsibility, Nancy Turnbull, a former insurance regulator and now a dean at the Harvard School of Public Health, presented a well documented argument that health plans could be doing more, and Richard Lord, CEO of the Associated Industries of Massachusetts, argued in detail that the impact of new funding proposals on employers is unfair.

The Boston Globe has had a comparable range of articles, editorials, and op-ed pieces.

The civility and reflectiveness of the public blog and print dialogue are impressive, and important to understand. There isn’t a referee enforcing constructive debate or a charismatic leader for the process like John Kitzhaber for the formation of the Oregon Health Plan.

My take is that we are seeing disseminated leadership at work. A critical mass of leaders is playing by the rules of constructive political collaboration. This supports the work of the Connector Board, which steers health care reform, conducts its own monthly public discussions, and sets an example for productive public debate.

Massachusetts health care reform is two years old. The honeymoon period is over. The next year, in which the state has to get a grip on the cost of the program, will test the durability and effectiveness of the disseminated leadership and public deliberation that have functioned well in years one and two.

Wednesday, July 23, 2008

Obama out on a health care limb

Barack Obama has put himself out on a limb with regard to health care costs. That's a good thing.

Obama has committed himself to saving $2,500 per family. One version of his plan specifies how the savings would be accomplished - a combination of computerized medical records, administrative savings, and improved chronic disease management. But the key component is the money - $2,500 per family - not the steps to get there.

Our national inability to modulate the growth of health care costs is not a function of inadequate knowledge. There have been innumerable well-documented reports on practice variations, failure to apply evidence-based treatments, excessive use of dubious technologies, and other patterns that add cost without adding value. And we know that apart from practice pattern problems, the bizarre complexities of the U.S. system add a wide range of administrative costs as well.

The inexorable rise of health care costs is best understood as a failure of political will. Costs soar upwards at double the rate of inflation because although we wring our hands and say “it can’t go on this way,” as a nation we have thus far chosen not to take the steps that would set limits on the cost trend.

A $2,500 savings per family represents 8% of our health care expenditures. As I've written in the past - when I have asked respected clinicians in different areas of medicine how much they could save in their area without any loss of quality if they were czar of their field - no one has said less than 25%, and many have said 50%.

A $2,500 per family reduction is achievable if we marshal the political will to do it. That's why Obama going out on a limb is a good thing. If (a) he is elected and (b) he devotes his skills as an inspiring leader to (c) educating us about the drivers of health care costs and the toll these costs take on our social fabric, then (d) the savings will be achievable.

What we need is leadership, not more studies.

Today's New York Times has a good article on Obama's $2,500 commitment. See also the speech I imagined a state governor giving on the topic ten years ago.

Sunday, July 20, 2008

Baby Boomers and Health Care Reform

I read always interesting Nicholas Kristof's New York Times op-ed on "Geezers Doing Good" over coffee this morning. The sentence "If we boomers decide to use our retirement to change the world, rather than our golf game, our dodderdom will have consequences for society every bit as profound as our youth did" caught my eye.

I've thought a lot about how we in the U.S. can shift our dominant values about health care from the current high technology/costs-be-damned/me-me-me configuration to a more communitarian perspective that thinks of individual and population health in a more holistic way.

After telling the story of Rob Mather, a British management consultant who now devotes himself to eradicating malaria, Kristof concludes:
If more people take on encore careers like that, the boomers who arrived on the scene by igniting a sexual revolution could leave by staging a give-back revolution. Boomers just may be remembered more for what they did in their 60s than for what they did in the Sixties.
In my clinical practice I've been struck by how often my older patients think about the implications of health care costs and utilization patterns for others. Sometimes they're thinking about their children - "I want to be able to help them, so I don't want to spend all my money, and theirs, on every little thing for me." Sometimes they're thinking about future generations - "I don't want us to keep piling up more debt for our grandchildren, and not investing in their education and a healthy environment."

The common wisdom is that boomers are infinitely selfish, and will demand ever more use of costly technologies - paid for by others - to make them more beautiful and athletic. But Kristof's column suggests an alternative vision. At least some may use their experience, brainpower, and leadership abilities to bring more sanity into our public discourse abou health and health care.

That's an idea to work on. Eradicating malaria is an ennobling goal. So is helping the U.S. steer itself away from the ultimately health-stifling way of governing health care that we are mired in today.

Tuesday, July 15, 2008

Prozac for Pets and Health Care Reform

In my section of Harvard Medical School’s required first year course in “Medical Ethics and Professionalism” this spring, we opened several of the seminar sessions going around the room canvassing for ethical issues we had encountered during the week. My aim was to encourage the students to see ethics as something always around us, part of everyday life, not as a bucket of high level issues (stem cells, persistent vegetative state, etc) that most physicians never encounter.

I kicked off the process by telling the group that after writing a blog entry about one of our class discussions I fretted about not having gotten their permission in advance, even though there was nothing personal in the posting. (They told me to chill out – it didn’t bother the Facebook generation.) We had some wonderfully lively discussions about topics like what a student’s obligations to a sleazy real estate agent were with regard to an apartment rental, and whether promoting attendance at a student run meeting by offering appealing food was an unethical bribe or an acceptable incentive.

The article on “Pill-Popping Pets” in Sunday’s New York Times Magazine was illuminating for me, much like the everyday life vignettes in the ethics class. Drugs for pets is a rapidly growing industry. Pfizer’s Animal Health division earned $1 billion last year, with drugs for “behavioral conditions” as a rapidly growing sector. Last year the FDA approved Pfizer’s Slentrol as the first weight loss drug for dogs! And Eli Lilly is marketing Reconcile, a chewable form of Prozac that tastes like beef, for canine separation anxiety!

Most observers of the U.S. health system agree that we have too little primary care and rely too much on pharmaceuticals and other technological interventions. Seeing the same pattern in our pet care system tells us how entrenched the pattern is.

The article quotes Dr. Ian Dunbar, a veterinarian critic of our approach to pet care, as saying “we lead an unhealthy lifestyle [with our pets] and then rely on drugs to correct it…I have never in my life had to resort to using drugs to resolve a behavioral problem.” With regard to obesity, Dunbar’s common sense approach is “just feed the dog less!”

Given our deeply entrenched values about managing health care – for people and for pets – we can’t expect preaching to drive the reform process. The ecological unhealthiness of SUVs has been obvious for years, but it has taken a rise in gas costs to stimulate a change in our car buying habits. Unfortunately for health care reform, the cost of health care doesn’t stare us in the face the way gas costs do when we fill up the tank. Policy gurus have hoped that high deductible health insurance (“skin in the game”) would drive reform, but for many the approach has simply led to anger at insurance companies and employer purchasers of insurance.

I think the likeliest analogue to the gas pump in health care is Medicare. I'll write more about the ethics of getting a grip on costs in future postings.

Sunday, July 13, 2008

Experimental Cancer Treatments in the National Health Service

Today’s Times of London has a poignant article by Andrew Lawson, a 48 year old pain medicine consultant in the British National Health Service and lecturer in medical ethics at Imperial College, about his own quest for cancer treatment. The story he tells raises large questions about health system ethics.

Seventeen months ago Dr. Lawson was diagnosed with mesothelioma, a rare cancer of the lining of the lung, caused by exposure to asbestos. Median survival after diagnosis is 12 months. Currently available treatments don’t work well. Mesothelioma is a bad cancer.

What follows is three excerpts from his article (in italics) followed by my comments:

1. After the diagnosis, Dr. Lawson saw three lung surgeons who gave him three different opinions, all delivered with the same degree of certainty. Here’s Dr. Lawson’s reaction:
“Doctors should discuss what is available and best for the patient, but some are tempted, subconsciously perhaps, to dress up opinion as fact. How many surgeons will tell you if a number of their peers don’t agree with them? That is not to say they don’t have your best interests at heart. It is just that the solution is preordained, the script written…When evidence is poor, what you get depends upon whom you see. So how can you make an informed decision in the absence of information? If your doctors do not know what is best, how can they advise?”
Sadly, this is true on both sides of the Atlantic, and probably throughout the world. It is difficult for physicians to integrate the pervasive uncertainties of medical practice with the intense responsibility we feel for our patients. This leads us to project more certainty than is warranted – sometimes with the rationale that our confidence will increase the likelihood that the treatment will succeed (placebo effect), and sometimes to assuage our own anxieties.

Good ethics require that – with rare exceptions – we should tell it like it is. In my practice I often imagined a panel of ten experts in the situation the patient and I were discussing, and made an educated guess as to the range of opinions they would express. I had at least one experience in which I told the patient my view, and explained that in all likelihood at least nine of the hypothetical experts, perhaps all ten, would disagree, and why.

Here Dr. Lawson is identifying a problem best addressed by professional education and clear ethical guidance from professional societies, combined with an understanding of what the public expects of us.

“There is a lot of talk about ‘choice’ on the NHS, but my experience as a patient has taught me that the choice you get is a choice of what you are offered…if a doctor knows of a better treatment but it is available only in the wicked private sector outside the health service, he or she is not supposed to tell you about it, on pain of disciplinary action.”

I have no independent knowledge as to whether this is a true statement about the NHS. I hope it isn’t. Dr. Lawson’s critique is reminiscent of the infamous “gag rule” that some misguided managed care programs imposed in the 1990s – that physicians should not tell patients about treatments that would not be covered by the insurance! Steffie Woolhandler and David Himmelstein made this practice infamous in their 1995 New England Journal of Medicine article “Extreme Risk – the New Corporate Proposition for Physicians."

I’ve heard non-disclosure defended on the basis of not causing pain for patients with regard to options their insurance will not cover that they could not afford. But obviously individuals should not be denied the opportunity to advocate/appeal and to seek other ways of gaining access to a treatment they believe is right for them. I am a strong supporter of the need for insurance programs – whether the British NHS or a US health insurer – to set limits. But those limits must be explicit, and patients need to be told about the universe of legitimate treatment alternatives.

“Looking at what ‘treatments’ were available, I came across a group led by Dr Dan Sterman at the University of Pennsylvania working on an experimental method of treating mesothelioma. Using genetically modified viruses, they make the body attack the malignant cells. It is unproven and in the early stages of clinical trials, but they have had some success in small numbers. The science behind it is appealing, it does not involve killing healthy cells as with conventional chemotherapy, and it does not involve surgery so radical that the surgical team cannot decide which bit of the patient to send to the recovery ward and which to the pathology lab…Trials of new drugs or therapies might make all the difference to people with a cancer that is difficult to treat. So why shouldn’t patients in the NHS be able to try such innovative trials in the US — or elsewhere — if they wish?”

If I or a family member had mesothelioma I - like Dr. Lawson - would want to explore the Phase I University of Pennsylania trial. I might well want to participate if I was eligible. But should insurance pay for such a trial?

In the US a number of states mandate coverage for Phase I cancer trials. In principle I believe it would be better to have participating in a trial paid for by research funds. The kind of trial Dr. Lawson is participating in is an educated guess. The treatment may be effective, but we don't know. It might even turn out to be harmful. It is difficult enough to try to educate the public about the concept of evidence based medical practice without further confusing the situation by covering treatments that by definition do not have an evidence base.

As medicine becomes more global, more and more patients will want to participate in experimental trials in other countries. Insurers will find it next to impossible to distinguish "reputable" from "sham" trials. As much as I empathize with Dr. Lawson's wish to participate in the Pennsylvania trial and agree that patients "should be able to try such innovative trials," I can't agree that this kind of support for research should be the financial responsibility for a health care system.

Friday, July 11, 2008

Parity for Mental Health Benefits

Sherry Glied and Richard Frank, two of the leading experts on mental health policy, have an important article on parity in the July 10 issue of the New England Journal of Medicine.

Health insurance typically subjects mental health services to more stringent coverage limitations and higher cost sharing than are applied to physical health services. Parity, which means equal insurance coverage for mental and other medical conditions, has been a central – but elusive – advocacy goal for decades.

There are two main reasons for the selective restrictions on mental health care. Both connect to ethics.

Stigma is the oldest. People with major mental illnesses such as schizophrenia and bipolar disorder, have historically been seen as “other,” a category to be set apart from the rest of humanity, like lepers. And, at the other end of the illness/stigma spectrum, Woody Allen, who portrays characters in lifelong psychoanalysis, stands for a view of mental health patients as narcissists who whine interminably about life’s ordinary frustrations.

The second reason is that even if we cure ourselves of stigma, actuaries fear that mental health services represent a black hole of expenditure.

Mental health costs can actually be managed. As Glied and Frank point out, “recent studies have shown that parity need not lead to unnecessary care under modern managed- care arrangements. The parity requirement in the Federal Employees Health Benefit (FEHB) Program, for example, led to equality in coverage but not to an explosion in the costs of care.”

In other words, if clinicians, patients, and the public, can agree that limits must be set, and that individual clinicians and individual patients can not, on their own, decide how to spend our collective health funds, we can afford mental health parity.

In this Congressional session, for the first time, both houses have passed parity legislation. The bills, however, differ in important ways, and it is unclear whether a compromise will emerge. The House bill defines the conditions covered under the law as all conditions listed in the Diagnostic and Statistical Manual of Mental Disorders (DSM), the compendium of diagnoses developed by the American Psychiatric Association and used world wide. The Senate bill leaves it to the insurers to decide what will be covered.

What’s at stake in the difference between the House and the Senate versions?

By specifying the full range of DSM diagnoses, the House is trying to prevent insurers from excluding too many conditions. It is indeed possible, and likely, that in unregulated markets, some insurers would seek competitive economic advantage by excluding as many patients with mental health needs as possible. The House bill seeks to ensure access, and shows distrust for the concept of managed care. But skeptics about mental health parity fear that in its quest for access, the House bill risks mandating coverage for conditions that may meet diagnostic criteria but do not create significant suffering and, by reasonable criteria, do not require medical intervention.

By leaving the definition of what will be covered to the insurer, the Senate version allows insurers to make flexible determinations of “medical necessity,” as is done with medical conditions. I had direct experience of this system when I practiced in the not for profit Harvard Community Health Plan HMO. In the right circumstances, patients and clinicians can collaborate in setting fair limits on the use of resources.

Glied and Frank end their discussion with a recommendation for compromise that is clinically wise, economically sound, and ethically admirable:

"Insurers should not be permitted to exclude entire categories of conditions from coverage. On the other hand, they should be permitted, and even encouraged, to use the existing criterion of “medical necessity” to ensure that covered services are directed to the types of mental disorders that are most impairing and disruptive and that can be treated effectively with medical care. Parity in mental health should not mean mental health services for all problems, for everyone, at any time — that’s not how good insurance works for any condition. But the promise of parity is that treatment for people with mental illnesses that cause impairment, disability, and suffering will not be excluded from insurance coverage, and effective legislation needs to make sure that happens."

Wednesday, July 9, 2008

Value-based Insurance Design

Value-based insurance design (VBID), in which cost sharing varies with the value of the health services, is (I hope) the wave of the future. It represents an insurance innovation that links evidence-based practice, cost containment, good ethics, and smart politics.

A commentary in the July issue of the American Journal of Managed Care, by Michael Chernew, the guru of VBID, and Joseph Newhouse, one of the leaders of the RAND Health Insurance Experiment, is worth reading.

Cost sharing is a blunt instrument. It reduces inappropriate and unnecessary care - a good thing from the perspective of cost containment and health, since every intervention carries potential risks. Unneeded treatments offer risk without benefit - not a configuration that shared funds should pay for. If I want an intervention of that kind, it is fair - and good for my health - to make me pay for it. Just as higher gas prices may lead me to walk to the store (good for my health and for the environment), higher cost sharing for inappropriate care may do the same.

But higher cost sharing reduces high value care as well. Increased cost can lead to decreased diabetes control, heightened blood pressure, and worsening of other treatable chronic conditions. The VBID concept has led to smarter cost sharing, as by reducing or eliminating copayments for diabetes medications and visits.

The ethical and political challenge will be - who decides what is "high value"? This isn't a problem when costs are being reduced. But if your diabetes medication is now free and my me-too branded medication has high cost sharing, I will want to know how the decision was made, who made it, and how I can appeal if I'm not convinced.

Debate about high value and lesser value is just the kind of debate we need more of in health care. Thus far VBID is associated with reduced cost for selected areas. This hasn't aroused much controversy. What I picture happening next is emergence of benefit packages with across the board cost sharing of significant proportions, high overall deductible limits, combined with a commitment to minimal or no cost sharing for high value interventions. If the low cost services are broad enough to constitute what fair-minded people would regard as a robust basic benefit package, the cost barrier to low value services would be ethically acceptable.

VBID won't eliminate argument. But, done properly, it would be the right kind of argument. What's the evidence? What counts as a valuable outcome?

Higher cost for gas is also a blunt instrument. Decreasing the sale of gas guzzlers is a good thing. Increasing the cost of operating ambulances or school buses isn't. But VBID has the potential for more discerning impacts. More power to VBID!

Tuesday, July 8, 2008

Avastin 1/Cost Control 0

An excellent article about the cancer drug Avastin in the July 6 New York Times provides an lucid overview of the scientific status of the drug. And, in terms of my focus in this blog on health system ethics, two brief comments in the article helps to clarify our national impotence in dealing with health care costs.

In 2004, the FDA approved Avastin for patients with advanced colon cancer, based on studies that suggested that Avastin extended life for four months. Subsequent larger studies, however, suggested that although the drug slowed tumor growth, it did not extend life in a statistically significant way.

In contrast to the FDA, the National Institute for Health and Clinical Excellence (NICE) in the UK concluded that Avastin "would not be a cost-effective use of NHS resources."

The New York Times quoted many experts who suggested that the benefit Avastin provides is small, and - in their view - NICE is correct in its judgment. For example, Roy Vagelos, a former CEO at Merck, said that "there is a shocking disparity between value and price, and it's not sustainable."

Here are the two comments that jumped out for me with regard to our inability to get a grip on costs. I have put the key comments into boldface:

1. Dr. Winer says that when he is not sitting in front of a patient, he thinks about whether drugs like Avastin are worth it to society. But when facing a seriously ill patient, who, based on clinical trial results, might benefit - even if only a little - from Avastin along with chemotherapy, he has to think about his patient's needs. "I can't say, 'Let's not use Avastin; it's a very expensive drug and I am worried about the cost to society...'"

2. What does it mean to say an expensive drug works? Is slowing the growth of tumors enough if life is not significantly prolonged or improved? How much evidence must their be before billions of dollars are spent on a drug? Who decides? When, if ever, should cost come into the equation?

Dr. Winer's use of the word "needs" for his assessment of Avastin's role for his patient is absolutely typical medical parlance. But it's wrong. We don't have evidence that allows us to say "If we want the patient to live longer he must have Avastin." A more accurate unpacking of "needs" would be - "I desperately want my patient to live longer. I hope that Avastin might help that happen. And, in the U.S. system, I am not expected to consider the cost to society."

The second quote raises questions about cost effectiveness and then asks the key question - "who decides?" In the UK, NICE decides, and is given that responsibility by the public, via the political process. In the US, no one is authorized to decide. The result is that cost-effectiveness is debated in the classroom and the media, but not in decision-making venues.

Only in the US is it possible to ask "when, if ever, should cost come into the equation?" with regard to a drug that produces ambiguous benefits at best for which billions of dollars are spent.

The correct answer to the question is that cost should always come into the equation. Every expenditure has an opportunity cost. Rather than anguishing as to whether it is ethically acceptable to consider costs, we must learn that good ethics requires us to consider opportunity costs in spending shared resources.

The practical question is - how do we, as a society, accomplish this learning? Moralizing won't do the job. If any readers see a way of advancing our public understanding without creating global budgets for health care, so that trade offs can't be avoided, please let me know.

Of course we could shift more and more of the cost to individuals, so that they could bring cost into the equation in light of their personal budgets. Sadly, for the time being, that's the American way!

Wednesday, July 2, 2008

Massachusetts Health Care Reform – Where the Wild Things Are

A line in Maurice Sendak’s classic – “Where the Wild Things Are” – describes the current situation for the Massachusetts health care reform process: “Let the Wild Rumpus Start!”

Massachusetts is in a wild rumpus of contending forces. It isn’t clear if the rumpus will capsize the reform process, or whether the alliance of government legislature and executive branches, employers, health plans, and citizens, will tame it.

As of this spring, 350,000, or 5.5% of the Massachusetts population is newly insured. This represents approximately half of those who were uninsured at the start of the health care reform process. Approximately half are enrolled in Commonwealth Care, the subsidized program for those who earn less than 300% of the federal poverty guidelines and do not have other insurance options. One quarter have enrolled in employer plans, perhaps triggered by the mandate that individuals must be insured or face a financial penalty. The rest are newly enrolled in Medicaid (18%) or via individually purchased, non-subsidized, coverage (7%).

An excellent New England Journal of Medicine article quotes Jon Kingsdale, the executive director of the Massachusetts Connector Authority, as saying “To maintain public and financial commitment to the new programs, controlling costs is 110% of the challenge for the next several years.” What Kingsdale says for Massachusetts is true for the entire country.

Given the fact that health care reform won’t succeed unless the #1 wild thing – cost – is tamed, it is illuminating to see ambivalence at play in Massachusetts. At the same time that the state is struggling to provide more affordable insurance, it is making decisions that drive costs up! What’s up? Is the state bonkers?

Some months ago the Connector Board – the entity that manages the reform process – decided that “minimum creditable coverage” (the level of insurance required for individuals to meet the mandate), must include prescription coverage. From a health perspective this is obviously the right decision. Meaningful health insurance should provide at least some drug coverage. But from the perspective of cost to the state, the drug benefit is a cost increaser.

And just this week the Massachusetts House overwhelmingly supported a bill that would require insurers to cover virtually all mental health and addictive disorders the same way they cover other medical conditions. From the perspectives of psychiatry, public health, and ethics, this is the correct policy. But as with pharmaceutical coverage, it will drive costs up.

The collision course between insuring everyone, controlling costs, and mandating wider benefits, is a high risk strategy, not an absent-minded inconsistency. Universal coverage and robust health insurance are both important goals. Massachusetts has chosen to embrace both, with the hope that the pressure this creates will energize efforts to contain costs.

From approximately 1980 – 2000, U.S. health policy asked insurers to control costs through selective contracting and utilization management. For a while this approach worked, but the backlash against managed care ultimately shot it down.

Massachusetts is hoping that (a) the population will recognize that (b) it wants universal insurance and broad benefits but that (c) it can’t have both without (d) getting a grip on health care costs and therefore (e) will demand that providers join with other stakeholders to make this happen.

The wild rumpus of cost control in Massachusetts is just starting. Stay tuned to see how it plays out!