Vol. 69 June 15, 2012 How to Avoid the “R” Word.

June 15, 2012

“We make those decisions all the time. The decision is not whether or not we will ration care — the decision is whether we will ration with our eyes open.” –Donald Berwick, MD

When infinite demand exists for finite resources certain decisions have to be made by those responsible for distribution of the resources. It is called “rationing“.  And that is what is causing all the palaver about reducing medical care costs. Who decides, how do they decide, and how do the decisions get implemented? “Rationing” has become the political lighting rod of that discussion and any politician or candidate (or even Director-designee of CMS) that does not successfully avoid its use is at great political peril.

A recent thoughtful essay in the NEJM advances the case for substituting “avoidance of waste” for the “R” word. (1) Since 30% of our medical care costs go to tests, treatments, drugs, and medical devices that in truth result in no patient benefit (2), the author argues that, at least, we should first eliminate the non-beneficial expenses. Consumer Reports in cooperation with American Board of Internal Medicine and 16 other medical specialty societies has recently published its list of non-beneficial medical activities for us to avoid. They call the campaign “Choosing Wisely”.

Since many very expensive items can be categorized as new technology, the author also argues for a more rigorous standard for the approval of new technology. New technology currently needs ONLY to prove that is safe and that is better than a placebo. There is NO requirement that it show that it has better outcomes than existing technology. This is true for drugs, PET scanners, linear accelerators, organ and bone marrow transplants, cardiac surgery, and all the different kinds of heart vessel stents. Highly technical, complex, and expensive gene treatment (“personalized medical therapy”) is just now peeking at us around the corner.

If a standard of improved outcome for new technology were in place, how would it be implemented? The ACA established the Center for Comparative Effectiveness Research within CMS to gather comparative outcome data and make recommendations, but the ACA also explicitly denies the CMS the authority to use such recommendations in setting Medicare reimbursement rates!

For example, in the very same issue of the NEJM there is an elegant multi-center study that leads to the implementation questions for a less dramatic, not-quite-so-emotionally-laden, but much more common condition than heart transplants and exotic “savior” cancer drugs; urinary incontinence in women. This study showed beyond a doubt that urodynamic testing results on women who go to a urologist because of urinary stress incontinence had no effect on the outcome of the surgery. The surgery is successful 69-72% of the time whether the urodynamic testing is done or NOT. In other words, the clinical judgement of the urologist in the office is enough to indicate who is likely to benefit from the surgery.

The urodynamic testing, with it’s charge in the U.S. of $640-$1503 depending on the insurance company and region, adds no benefit. The article’s authors (all 34 of them) flatly state that urodynamic testing for women presenting with stress incontinence should not be done. (the same conclusion made by NICE, National Institute for Health and Clinical Excellence, in the U.K. in 2006). The article does list four specific instances where urodynamic testing might prove helpful; 1) patients with previous surgery for incontinence, 2) presence of neurological disease, 3) patients planning more extensive pelvic-organ relapse corrective surgery, and 4) urge-predominant incontinence rather than stress-incontinence. All of these definable situations can be documented in the medical record for the few patients who have them.

How could such a reasonable, well-founded recommendation to reduce costs without compromising quality be implemented?

1) Medicare could refuse to reimburse for urodynamic tests in uncomplicated stress incontinence patients. This is without doubt the most direct way to save these costs. Private insurance would soon follow suit after the political and medical backlash quieted down (urodynamic studies are almost always done in the urologist’s office and can represent a significant revenue stream to the office). Current ACA language explicitly prohibits this action.

2) ACO’s could implement a practice guideline recommending avoidance of urodynamic testing before usual stress continence surgery. Any resulting cost savings could be shared by all the physicians in that ACO. Urologists would receive a portion of the savings to offset their revenue loss, and they in turn could ask the other specialties in the ACO, “What have you done for us lately, so that we can share in some of your cost savings”.

3) Physician leaders in the urological specialty and academic centers could support educational efforts to inform their members of the non-benefits of urodynamic testing for most patients and wait for its use to fade away under the weight of replicating, confirming studies, and editorial comments.

This third option is often how our practice patterns currently change, but it is a slow process as shown by our continued discussions of the comparative benefits of open heart surgery or various vascular stents. That this “revelation” about the non-benefits of urodynamic testing has been around since 2006, but still warrants an article published in a 2012 NEJM is another clue about the pace of change. Given the inevitability of rationing and the moral repugnance of doing so with broad-brush budget caps monitored by bureaucrats, arbitrary decisions by non-accountable insurance companies, price-based decisions by for-profit drug companies, age-based discrimination, or by economic or social class classifications, we can only hope that we can find a better way.

Comparative Effectiveness Research under the ACA could develop evidence-based standards to be implemented by ACOs of high quality, cost-conscious physicians who would then share in the savings resulting from their hard work of changing practice patterns appropriately. Otherwise, we may have to settle with our current system of “muddling through” and try to be patient with the plodding pace of change as we watch the treasury run dry.

It might help if we did replace “rationing” with “avoidance of waste”, but I don’t hold out too much hope for that. It will take more than one article and a less insipid term to capture our imagination.

In my next blog on July 1, I will describe how to avoid the “F” word.

1. “From an Ethics of Rationing to an Ethics of Waste Avoidance”, Howard Brody, M.D.,Ph.D; NEJM 366;21 May 24, 2012: p. 1949
2. “The Implications fo Regional Variations in Medicare Spending”, Wenneberg et al., Ann Intern Med 2003;138: p. 288
3. “A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery”, Nager et al., NEJM 366;21 May 24, 2012: p.1987


Vol. 53 October 15, 2011 The Heart of the Matter

October 14, 2011

Imagine that you are over 65 years old and you have a failing heart. Your doctor tells you that you are at “maximum medical treatment” and are not eligible for a heart transplant because of your age and other medical conditions.  Then the doctor mentions that a pump could be implanted in your body to help your heart pump more blood; a left ventricular assist device or LVAD.

Imagine a small device put into your chest during open heart surgery that could help you pump enough blood around so that some of your old energy would return and you could resume some, but not all, of your usual activities.

Imagine that Medicare would pay for the operation, device, and medical follow-up. Then try to imagine what the $228,039,342 Medicare paid for about 1500 of these operations would look like if spread out on a table in hundred-dollar bills.

Imagine what it would be like to be one of the 55% (815) of patients who survived the operation and left the hospital alive after receiving this pump. Imagine how even happier you would be if you were one of the 43%  (350) discharged alive who was still alive 2 years later. Imagine your relief when Medicare pays the average $1,000 a day hospital rate for the 56% of pump recipients who have to be rehospitalized at least once in the 6 months after implantation.

Imagine your perplexing thoughts when a statistician tells you that your life extension cost about $60,057 “per quality-adjusted life-year”.

Imagine that your psyche and your family can handle the burdens of multiple medical visits, utter dependence on the infallibility of a medical device, 24/7 family care and vigilance, strict adherence to medication regimens, worries about medical and financial complications, and alteration of body image perceptions that can lead to depression and anxiety.

Imagine how your life might actually end. If you turn off the pump it is suicide. If your doctor or family member turns off the pump it is either euthanasia, assisted suicide, or ethical withdrawal of therapy depending on the status of your permission (and maybe the State you are in).  Perhaps you will develop a new fatal condition from which you will die with the pump running. Imagine if you lived long enough to require a pump replacement.

Imagine that part of the pre-operative process before the pump is implanted is a detailed discussion with your physician (and your family hopefully) about how and when YOU would want the pump turned off.


Then imagine how a “rationing” process to cut medical care costs under Medicare might work in this situation.

Imagine how it might work if you were the patient rather than Mr. Cheney.

Blogs have already appeared making the argument that Steve Jobs would not have lived his “extra” two years with a liver transplant under U.K. or Canadian health systems.

Medical ethics are about “where you draw the line”. Remember that in the beginning of this scenario your doctor said you were “ineligible” for a heart transplant. That was a drawn line, a rationing decision. Our current dilemma and sometimes heated discussion is really about WHO draws the line. (Medicare, Medicaid, private insurance or pharmaceutical company, Congress, professional specialty societies, health care lobbyists, medical ethics committees, Comparative Effectiveness Research in the U.S., NICE in the U.K., individual physicians and patients, or God)

*shamelessly copied from Matthew McConaughey’s dramatic closing speech to the jury
saving Samuel L. Jackson’s life in A Time To Kill  by John Grisham.

Journal of Medical Ethics, Spring 2011, Vol.18, issue 2, published by Lahey Clinic; LVADs as destination therapy: difficult ethical decisions.

Taming the Beloved Beast: How Medical Technology Costs are Destroying Our Health Care System, Daniel Callahan, 2009, Princeton  University Press

Vol. 43 April 15, 2011 “I Told You So”

April 15, 2011

“The [U.K.] proposals draw heavily on market-style incentives to drive improvements in outcomes and increase responsiveness to patients and the public. But they also include new arrangements for accountability, fundamental changes to the structure of the NHS, and a shift in the responsibility for paying for health services to groups of capitated physicians. (1)

Sound familiar?  Those words describing the current British health care reform effort could serve as a description of U.S. health care reform and the creation of Accountable Care Organizations (ACO). I know I bill myself as an “evidence-based” blogger, and therefore distant from the personal ranting, either angry or self-serving, by other bloggers, but this article in the New England Journal of Medicine spurs me to electronically shout out in triumph, “I told you so!”  In my blog (2) and in a paper (3) I wrote in 1967 (when?) I opined that  there seemed to be more similarities than differences between the U.K. and U.S. health care systems.  This well-researched article in the NEJM  agrees with me.

BOTH the U.K. and U.S. reform acts:

Seek to reduce costs by making providers accountable for total per capita health care costs ($32B less for U.K.over 5 yrs. and $100B less for U.S over 5 yrs.)

Seek to strengthen primary care

Remove payment incentives to increase volume of patient visits (Pay for “value” in U.S.;  “fixed budget” in U.K.)

Do NOT require providers to “bear risks” for  catastrophic illness like insurance companies do now (but that is an option for ACOs in U.S.)

Primary Care Physicians (PCP)
While the U.S. pays lip service to strengthening the PCP, the U.K. proposal really means it. U.K. will give the general practitioners CONTROL of over 70% of the NHS budget! The GPs will form primary care groups called GP Consortia. These Consortia will buy additional care for their registered patients from hospitals and specialists competing for contracts. 170 Consortia have already been formed and another 100 are being planned. A physician-run ACO in the U.S. would be similar, but the ACO would include both primary care and specialty physicians like present day multi-specialty groups. No one knows how many ACOs will be developed, and many of them will be formed by hospital systems.

Commentators on both sides of the Atlantic have voiced concerns that physicians will not be able to deal with these new managerial responsibilities successfully; physicians in neither country like to develop budgets, live by budgets, or even value management/administrative skills.

Quality Incentives
In the U.K. the National Institute for Health and Clinical Excellence (NICE) will set care quality standards for the Consortia and the contracts they grant  or “commission”. The Center for Effective Research (CER) established by the U.S. Affordable Care Act will have the same role of issuing standards of care. The practice of setting national targets for care  will be dropped in the U.K. to be replaced with “a system of open reporting of data on performance and clinical outcomes.” This newly available data will allow patients (“the market forces”) to choose high quality care among the “any willing providers” in the absence of national targets and differential prices. As in the U.S. there is little evidence that patients actually use such data when it is available to make decisions about where to seek care.

Two Big Differences
The U.S. ACO incentivizes coordination of care between primary care, hospitals, and specialist physicians. The U.K. Consortia will control the money and issue contracts for hospital and specialist services. This could increase competition and hinder collaboration in the U.K.

U.K. patients will still have to register with one GP though they will have more freedom of choice of GP, i.e. patients will no longer be restricted to registering with the closest GP to their home.  ACO patients will be assigned based on “previous patterns of care” though there will be incentives to use “participating providers”.

What are the take home messages?
We are not the only country muddling through a major health care reform while walking the line between regulations and market forces.

Everyone seems to be seeking the goals of higher quality and lower costs through electronic information upgrades.

Given the similarities between the U.S. and U.K. systems,  the charge that Dr. Don Berwick, Head of CMS and a pediatrician, “likes the NHS too much” seems a bit ridiculous.


1. NEJM 364:14, April 7,2011, p.1360-66
2. http://www.hubslist.org, Feb. 1, 2011
3.Mathewson, H.O.. “General Thoughts About General Practice: a medical student’s view of the future of general practice in the United Kingdom.”  J Med Educ. 1968, Jan;43(1):36-41.

Vol. 30 October 1 ,2010 Fake Pharma and Terror Pharma

October 1, 2010

If, by chance, you are one of those people who ordered some excellently priced prescription drugs from a slick, clean, multi-colored Canadian website (without having to submit a prescription, of course), and then received, a number of days later, a plain brown package postmarked from India, you MAY have received counterfeit drugs.
You may never know.
Neither may the FDA.

The FDA did discover in June of 2010 that some Tamiflu (an anti-flu drug in great demand at the time) postmarked from India was really cloxacillin (an anti-staph drug unrelated to influenza).

  • Estimate of the world market for all types of counterfeit drugs: $75 Billion annually

The yearly appropriation to the FDA is $2.5 billion, or $8 per person per year. That is what the FDA has to safeguard us from harmful or ineffectual prescription drugs. Congress never actually authorizes (“allows the checks to be written”) that much money and a shortfall of about $600 million each year is made up by collecting “user fees” from pharmaceutical companies making new applications for drug approval. Before you jump to the conclusion that this is too cozy a situation, “the hens are paying the fox”, you should know that Big Pharma complains that “sponsors of new applications have had to triple the time taken to respond to FDA inquiries.”

Counterfeit hypertension drugs might make themselves known eventually as your blood pressure climbs, assuming that someone is checking it regularly. Counterfeit diabetes control drugs might declare themselves sooner than that. A kilogram of Viagra can be bought in China for about $60 which when converted into 25 mg. tablets of Viagra is worth $200,000 in the U.S. Counterfeit Viagra, Levitra, Cialis, and the like would probably be the quickest to be unmasked as fake. Maybe they should add an additional warning to the drug ads,

. “If your erection lasts more than four hours, call your physician.
. If it lasts less than four minutes, call the FDA.”

Of course, that may not be true since the literature is now full of papers about the powerful effects of placebo. “If you think you took Viagra, you may be able to act like you did.” That would be a fun study for T. Kaptchuk to do; “Placebo Effect on Penile Erection Compared to Viagra and Fake Viagra; a survey of 100 middle-aged Boston academics”.

There are six pharmacies that are approved by the National Association of Boards of Pharmacy to provide drugs on the internet. One way to make sure you are getting what you have asked for on the Web is to use one of those.

Botox is an apparent favorite for counterfeit drug sellers. In 2006 a “naturopathic” doctor in Colorado pleaded guilty and was sentenced to 9 years in prison for selling $1.5 million of “fake Botox” to doctors across the U.S. There are no less than 20 companies from China selling “botox” on the web. Russia and India are the two next largest suppliers.

Botox is made from botulinum toxin , a powerful neurotoxic agent that was actually developed as an “orphan drug” in 1959. “Orphan drugs” are agents developed for patients with rare or unusual conditions and are subsidized by incentives from the U.S. government. It was approved for a small number of patients suffering from neck and facial muscle diseases in 1989. Its use soon extended to helping control spastic muscles in patients with cerebral palsy.

When its effect of erasing facial wrinkles by paralyzing the underlying muscles was discovered in 1992, its use literally exploded, first by plastic and ENT surgeons for “non-surgical” facelifts, and now, by just about anyone who wants to throw a living room”botox party”. In 2007 use of injectable botox was the most common cosmetic procedure (4.2 million/yr.) according to the American Society of Plastic Surgeons.

As a potent muscle paralytic in very small doses , and a lethal agent in larger doses, Botox is a potentially effective terrorist weapon due to its relatively easy manufacturing and availability through the internet.

Vol. 9 November 15, 2009 Health Care Reform, Comparative Effectiveness Research

November 17, 2009

“Rationing means making the most of your available resources. The most ‘rationed’ facility I have ever been in was the Albert Schweitzer Hospital when Dr. Schweitzer was running it. He insisted that the use 0f absolutely every medicine, every tool, and even every piece of paper be used maximally for the patients’ benefit.”
-B. Lachlan Farrow, MD, Assoc. Prof. of Medicine, Harvard Medical School

Number of annual U.S. deaths in people of ages 18-65 yrs. due to lack of health insurance: 18,000-45,000 (1)

Number of World Trade Center collapses that number of deaths is equal to:  6-15

Average cost of Avastin (an inhibitor of blood vessel growth) for one year: $50,000

Number of weeks it prolongs the life of patients with metastatic breast cancer: 0

Amount of improvement in quality of life in those same patients: 0

Significant reduction in progression of disease on Xray images: yes

  • Dr. Forrow’s illustration of his view of “rationing” care for those patients might be to give them the choice of Avastin or “free” home care services (including family support, transportation, etc.), nursing home and/or hospice care, all medications, and a $10,000 for a cruise of their choosing for the same cost! (2)

Per cent average increase of Mass Blue Cross premiums for small businesses in 2010: 15 – 18 (3)

Number of Congressmen using nearly the identical words as Genentech lobbyists promoting the need to keep research jobs in the U.S. as part of the health care reform bill:  42   (22 Republicans and 20 Democrats – at last, some bipartisanism in the health care reform debate) (4)

Amount of stimulus money earmarked for Comparative Effectiveness Research (CER) by Congress in February 2009: $700 million (spilt between NIH and the Agency for Healthcare Research and Quality)

  • CER is a new program aimed at analyzing groups of patients to compare the effectiveness of alternative strategies of drugs, devices, procedures, and diagnostic tests. This is a significant change. For instance, to get FDA approval for a new drug a pharmaceutical company just needs to show that it is better than no drug (placebo). CER raises the bar by asking for data that a new drug (or other therapy or test) is better than the ones already available.

Per cent of annual health care cost increase due to use of new technology: 50  (4)

Chances that CER will be targeted as “rationing” by opponents of health care reform: 100%  (has already occurred)

  • From the originator of the “death panel” label, Betsy McGaughey, former lieutenant governor of New York:  She connected the CER initiative with the electronic medical record initiative to warn that clinicians would get punished for failing to comply with rationing guidelines in treating individual patients ! (5)
  • Specific wording in the House bill on health care reform (HR3962) establishing a Center for CER (a step above a program under two different agencies) prohibits any CER Center authority over “mandated payments, coverage, or reimbursement policies” (6)

1. Institute of Medicine 2002
2.  Ethics of Health Care  Reform, B.L. Forrow, PriMed  Conference, Boston, November 2009
3. Boston Globe, Nov. 15, 2009
4. Congressional Budget Office (from Medical Ethics, Lahey Clinic, vol. 16:9 , Daniel Callahan)
5. NEJM, 360;19, May 7, 09,p.1929 (quoting Bloomberg.com)
6. http://www.newamerica.net/blog/new-health-dialogue

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