November 30, 2009

The Heart of the Matter

Just before the annual deluge of holiday visitors began inundating the Magic Kingdom, over 20,000 people gathered in Orlando, Florida to attend the American Heart Association annual meeting. At one late-breaking scientific session, Dr. Joseph Rogers, a Duke University cardiologist, presented the results of a study of a nifty new cardiac device, the HeartMate II (to distinguish it from its predecessor, HeartMate I, also known as HeartMate XVE). This remarkable 390-gram contraption is the next best thing to a heart transplant for patients with severe heart failure. It is a “ventricular assist device,” (VAD) implanted in the abdomen, hooked up to the heart to propel blood through a failing ventricle, and powered by an external generator. The study, published the very same day in the online version of the New England Journal of Medicine, showed that patients with the new device lived longer and better, with fewer complications, than those who got the earlier variety.

Just six years ago, the Centers for Medicare and Medicaid Services (CMS) approved use of the HeartMate I in Medicare patients as “destination” or definitive treatment of severe heart failure. Based on the results of a 2001 study, the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial, CMS concluded that the device was “reasonable and necessary” for the treatment of advanced heart failure and therefore, as required by its 1965 Congressional mandate, agreed to pay for implantation of the device.

Physicians, however, were not convinced the device was reasonable or necessary. In fact, the number of patients receiving a ventricular assist device has fallen every year since CMS approved its use. Between March, 2006 and June, 2009, a total of only 1664 HeartMate I’s were implanted (just under 500 per year) and 90% of them were used as “bridge to transplant,” that is to tide patients over until a heart became available for transplant, rather than as “destination therapy,” or permanent treatment. Physicians evidently were not impressed by the data that patients who had a ventricular assist device lived longer than those receiving “maximal medical therapy.” Even with the device, one-year mortality remained high at 48% and two-year mortality at 77%. Moreover, HeartMate I recipients were at risk of stroke, infection, and device malfunction.

Will physicians be more enthusiastic about the new HeartMate II? It is smaller—small enough to fit into a woman, unlike the earlier version. It uses a continuous rotary system rather than a pulsatile mechanism, which means it’s quieter and more durable. And the new device is clearly superior to the old one—the randomized study reported in Orlando found that 46% of those with the new device were alive after 2 years without having sustained a debilitating stroke or required replacement of the device, compared to 11% of those who got the original model. Quality of life was also improved, with recipients of the new HeartMate able to walk further and do more for themselves.

Are these results good enough? They will almost surely be good enough for the Food and Drug Administration to approve use of the device as destination therapy and for Medicare to follow suit by approving reimbursement in Medicare patients—currently Medicare pays an average of $177,000 for a hospitalization in which a ventricular assist device is inserted. Whether physicians will regard the new pump as ready for prime time remains to be seen.

The deeper question is whether we should be putting more and more resources into shoring up failing hearts in patients near the end of life or whether, instead, we should concentrate on palliative care for patients dying of heart failure and on prevention to avoid the development of heart failure in the first place.

Palliative care is an effective, well-regarded approach to end stage heart failure. It focuses on comfort and on supporting patients and their families as the end draws near and may involve enrollment in hospice. Individuals whose heart cannot pump properly repeatedly suffer from fluid backing up into their lungs, swelling their legs, and filling their abdomen, causing shortness of breath, difficulty walking, and fatigue. Instead of hospitalizing these patients, often transferring them to the Intensive Care Unit where they may be attached to a ventilator that forces oxygen into their lungs and put on an intravenous drip to try to stimulate the heart to contract more forcefully, palliative care strives to keep them home. At home they use oxygen and medication such as morphine to help them breathe. Interestingly, the studies of the left ventricular assist device compare patients receiving one particular device to those getting another type (the new study) or patients receiving a device to patients receiving “maximal medical therapy” (the earlier study), but never compare patients receiving a device to those getting palliative care.

Prevention makes a lot of sense in the case of heart failure. Heart failure is the leading cause of hospitalization in individuals over age 65. Americans have a 20% life time risk of developing the condition and treatment costs the US upwards of $30 billion per year. But we know what causes the heart to fail: it is high blood pressure, diabetes, or coronary artery disease (which in turn is caused by some combination of high blood pressure, diabetes, high cholesterol and smoking). And every one of these predisposing conditions is treatable or preventable. While there are few good studies of what it would cost to institute a comprehensive set of measures to prevent heart failure, we do know that 82% of the cardiac events in one observational study, the Nurses Health Study, were attributable to diet and lifestyle issues. An Australian analysis suggests that the best way to prevent heart failure is by a combination of medical preventive strategies (proceeding patient by patient to assess risk factors and intervene to treat high blood pressure, diabetes, and high cholesterol) and public health strategies (using legislative and environmental approaches to promote a healthy lifestyle).

America has its heart set on the technological fix—the HeartMate II is the latest in a series of ingenious approaches to treating the chronic diseases afflicting older people. But its time to get to the heart of the matter, trying to prevent the major scourges that we have the knowhow to avoid, and palliating those who, despite our best efforts, are dying.

October 15, 2009

Balking at Baucus?

Democrats and Republicans alike are balking at the Baucus proposal, the latest health care reform proposal to emerge from Congress. Not surprisingly, this enormous bill has something for everyone to hate. It attempts to legislate improvements in access and quality while simultaneously addressing cost.

But what is sometimes lost in the furor is that there are actually two kinds of costs that reform must deal with: the cost of implementing the new programs (principally the cost of requiring that most Americans have health insurance, which means subsidizing premiums for individuals with low incomes); and the rising cost of health care, principally the Medicare program, which is expected to run out of money in 2017.

The Baucus proposal has a price tag of $774 billion over 10 years (though in the last few days, various modifications have added another $28 billion), which refers to the first kind of cost. But how does the Baucus proposal address the second cost issue, containing spending?

The Congressional Budget Office predicts that total spending on health care will reach 36 percent of gross domestic product by 2035, with Medicare costs alone comprising 8 percent of GDP. The vast majority of the increase in Medicare costs will be attributable to increased spending per enrollee, not to the aging of the population. And the single most important factor accounting for the increases is the emergence, adoption, and widespread diffusion of new medical technologies.

Some of these technologies are clearly beneficial; others are beneficial to some of those who receive the new drugs or devices, but are unnecessary or even harmful to numerous others for whom they are also prescribed. And some of the beneficial technologies produce only a very small benefit but at an extremely high cost, as set by the pharmaceutical or device manufacturing industries. Effective Medicare cost control will need to go beyond appealing proposals of dubious financial benefit such as expansion of preventive services and elimination of Medicare fraud (though this could save as much as $17.2 billion per year if fraud were totally eradicated).

What else does the Baucus bill suggest? It makes three significant proposals that actually might work. Collectively, they seek to modify the culture of medicine by altering the way medical care is delivered and how it is paid for.

The beauty and the peril of its strategy is to create an infrastructure for designing a program rather than actually spelling out what the program will be. The beauty is that it does not require making politically unpalatable claims, for example that CMS may need to stop reimbursing for technologies that are not cost effective. The peril is that the various centers and institutes the plan will spawn may not in fact do what they need to in order to control costs. Just what are these centers and institutes?

The most familiar one, because it is also found in the “Affordable Health Choices Act” of both the Senate and the House, is a nonprofit patient-centered outcomes research institute. This would conduct research comparing the clinical effectiveness of medical treatments. To be effective, its work would need to translate into the CMS reimbursement policies: it would have to become an extra-government agency along the lines of the much-maligned but crucially necessary British National Institute for Health and Clinical Excellence (NICE).

The second new institution is an independent Medicare commission charged with submitting proposals for reducing excess Medicare cost growth. Strong wording would effectively require Congress to do what the commission requested or come up with a fiscally equivalent alternative. This is an example of the politically astute approach of leaving open just what the independent commission would recommend.

The third institution is an innovation center within CMS to test, evaluate, and expand different payment structures and methodologies to foster patient-centered care, improve quality, and slow Medicare cost growth. Among other endeavors, the center is mandated to pilot the development and evaluation of a system of bundled payments for a single episode of care – that is, a single payment covering care in the office, the hospital, and the skilled nursing facility. For bundling to work, doctors, nursing facilities, and hospitals will need to band together to form accountable care organizations, and Baucus promotes the establishment of these organizations by offering them a share in the cost savings they generate.

Will the research institute, the commission, and the innovation center, with it assorted pilot programs, do the job? Without knowing just what they will recommend, it is impossible to be sure. But their focus will be on the right areas: figuring out what works and what doesn’t, determining who benefits from new technologies and by how much, and developing systems of care that assure that patients get the interventions that work but not those that don’t. It’s our best shot to date.

This article appeared on the Hastings Center HealthCareCostMonitor on September 24, 2009.

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End-of-Life Planning is No Conspiracy

Far from a left-wing conspiracy to deprive you of desirable care near the end of life, advance care planning - talking with one’s physician about goals and preferences for medical care in the event of incapacity - is the best way to ensure that your wishes are respected if you lose the capacity to speak for yourself. Because it is widely recognized as the ideal way to prevent both over-treatment and under-treatment, it has become the standard of care over the past 15 years.

Survey after survey indicates that most patients want to have end-of-life discussions but most do not have them. For example, a 2005 AARP survey in Massachusetts of members over age 50 found that 89 percent of those polled rated having honest answers from their doctor about end-of-life conditions as very important but only 17 percent had discussed their preferences for such care with their physicians. Study after study also shows that American patients continue to die in pain, on ventilators, and in the intensive care unit, though many of them did not want such treatment at the end of their lives. For instance, the Robert Wood Johnson study “Means to A Better End: A Report on Dying in America Today’’ found that 42 percent of all nursing home residents were persistently in pain, and the Dartmouth Atlas of Health Care found that 18 percent of deaths nationwide take place in intensive care units and 32 percent in the hospital, although the majority of Americans say they would prefer to die at home.

When physicians are asked why they do not regularly engage in advance care planning with their patients, they report that they do not have the time for such conversations. The legislation under consideration in Congress that would allow physicians to be reimbursed for an advance care planning discussion with their patients is simply an attempt to correct the imbalance between what patients want and clinical reality.

The current proposal is far from the first attempt to facilitate advance care planning. The federal Patient Self-Determination Act of 1990 mandates that all patients admitted to a healthcare facility receiving Medicare or Medicaid funding be asked if they have an advance directive (a written document specifying their wishes in the event of incapacity) and be given information about advance directives if they do not have one. Every state as well as the District of Columbia has advance directive legislation, which provides for the use of a living will (a statement about preferences in particular clinical situations) or designation of a healthcare proxy (a person to make medical decisions in the event the patient loses the capacity to do so) or both.

The only question we should be discussing is whether a federal mandate to allow physicians to bill specifically for discussions about goals and directives for care will actually succeed in stimulating advance care planning. That is why the bill calls for monitoring the use of the planning code - if it is ineffective in promoting end-of-life discussions, then we will need to find other strategies. The issue is not whether advance care planning is desirable; it is how best to encourage patients, families, and clinicians to have such conversations.

The reason it is important to have the conversations is that death is not optional. What is optional is how we will experience life’s last stage: Will we be in pain or will we be comfortable? Will we be in the hospital or at home? Will we be in an intensive care unit or enrolled in hospice? Discussions about end-of-life care have been shown to result in patients experiencing less depression, less pain, and less anxiety in their final days. Advance care planning gives us the opportunity to avoid both over- and under-treatment by allowing us to express our preferences and by discussing them with our personal physician.

This article appeared as an op-ed in the Boston Globe on August, 12, 2009.

Falling Down on the Job

It’s not often that a report appears that identifies a problem and at the same time, another report is released that offers a solution to that problem. But that may be what happened this month with the publication of an article describing the frequency of hip fractures and their complications and another article detailing an intervention that reduced the complication rate after hip fracture.

The first study presents data on hip fractures in the U.S. between 1985 and 2005. Previous data indicated that there are about 350,000 hip fractures every year in the U.S., almost all of them in people over 65 and the vast majority in people over age 75. Half of those who break their hip never return to their baseline level of mobility, 20% die within a year, and 25% of those who lived independently before the fracture require permanent nursing home care afterwards. The new report concludes that hip fracture rates and subsequent mortality among people over 65 are declining. But closer inspection of the data shows a different picture.

What the report really shows, as the authors indicate in the discussion section of their paper, is that there were two distinct time periods worthy of analysis. Between 1986 and 1995, the incidence of fractures increased in both men and women (corrected for age) but between 1995 and 2005, the incidence declined steadily. It declined a lot: among women, the incidence fell 25% and among men it fell 19%. But the mortality story is another matter. Looking at death rates at 1 month, 6 months, and at a year after hip fracture, the study found that between 1986 and 1995, mortality fell, but between 1996 and 2005, there was no improvement in mortality whatsoever.

The decline in the rate of hip fractures is good news, though it’s not entirely clear what caused it. The authors point to lifestyle factors, such as greater intake of vitamin D and calcium, along with increased exercise. They also point out that bisphosphonates, medications used to treat osteoporosis, were introduced at just about the same time that hip fracture rates began to fall, but these drugs can account for at most 40% of the reduction in risk.

The lack of improvement in mortality in the recent 10-year period, however, is troubling. Much of it reflects the fact that older people who fracture a hip are frail—and their frailty predisposes them to other medical problems in the following year. But the second article on hip fractures that appeared in a major medical journal this month offers a ray of hope. Reporting on the impact of co-management of hip fracture patients by orthopedists and geriatricians, investigators from the University of Rochester School of Medicine found enormous improvements in outcomes with their model.

Patients cared for in the “Geriatric Fracture Center” in Rochester were older than their counterparts who received standard orthopedic care (mean age 84.7 vs 81.6), they were more likely to have dementia (53% vs 21.5%), and they were much more likely to come from nursing homes and assisted living facilities (60.6% vs 12.2%). Despite all these differences, the co-managed patients fared far better. They went to the operating room much more quickly (in an average of 24.1 hours vs 37.4 hours), which has been shown to lead to better results. They stayed in the hospital less long (4.6 days on average vs 8.3 days) and they had fewer complications (30.6% vs 46.3%). In particular, they were less likely to develop delirium (acute confusion), infection, and blood clots, all of which predispose to early death.

The finding that “co-managed” patients did better than those cared for exclusively by orthopedists does not necessarily translate into improved survival rates. Some of the long-term mortality is unrelated to the hip fracture and simply reflects the reality that people who break a hip tend to be old and sick and that people who are old and sick die. But the component of the mortality from hip fractures that is amenable to intervention probably involves the post-operative management of patients. It is precisely those nasty complications of surgery that, over time, cause death. Finding a way to take care of individuals with hip fractures that decreases their risk of complications is an excellent strategy for preventing death.

Is the “Comanaged Geriatric Fracture Center” really the answer? It may be. The Rochester study was a retrospective cohort analysis, so it is possible that the findings reflect undetected differences between the patients or other differences in the institutions where care was provided. A randomized trial, in which some patients receive one form of care and others, chosen randomly, get the other type of care, would demonstrate decisively whether and how much co-management helps. But joint care by orthopedists and geriatricians is in widespread use in other countries such as Australia and New Zealand, with good results. And similar but less potent strategies have been used in the U.S., such as the use of geriatric consultation for patients on the orthopedic service. When this multidisciplinary approach was instituted at Oregon Health Sciences University and at the Johns Hopkins Bayview Medical Center, fewer complications, decreased length of stay, and earlier surgery were all observed. These systematic ways to assure improved care for older people with hip fractures can be instituted now. There’s pretty compelling evidence that they work and cost calculations suggest they save money, too. If we don’t start introducing this model into practice, we’re falling down on the job.

August 26, 2009

Messing with Medicare

Senior citizens have been coming out in droves to express concern that health care reform legislation will deprive them of what they now have. Although most of the provisions of the proposed bills deal with ensuring access to health care for the currently uninsured and with regulating private insurance companies, Medicare enrollees are worried that “the government” will “mess with Medicare,” a program which many seem not to realize is the paradigmatic “public option.” Just how would health insurance reform affect Medicare—in fact, not in fantasy?

Both the Senate’s “Affordable Health Choices Act” and the House of Representatives’ “America’s Affordable Health Choices Act of 2009” address access, quality, and cost-containment. The majority of the many sections of these bills deal with such areas as individual mandates, employer requirements, premium subsidies, insurance pooling mechanisms, and benefit design. Only a few have anything to do with Medicare. One provision, expansion of Medicaid, would increase the number of older people who are “dually eligible,” i.e. who would qualify for both Medicaid and Medicare. This would increase the coverage available to older individuals, not decrease it.

Under cost containment, the Senate bill would establish a “Health Care Program Integrity Coordinating Council” to prevent health care fraud, waste, and abuse, in both public and private coverage. Who could be against eliminating fraud and abuse? In fact, a recent article in the New England Journal of Medicine estimated that the annual price tag for fraud and abuse is $60 billion, with fully $36 billion of this related to Medicare and Medicaid, the current public programs--enough to pay for health care reform. The House bill has a few more provisions under the cost containment heading. These include reducing payments for potentially preventable hospital readmissions—that just means giving hospitals an incentive to solve your medical problem the first time you are hospitalized, instead of making you come back again and again to get it taken care of. In a similar vein, the House bill calls for hospitals to report hospital-acquired infections and suggests eliminating Medicaid payments for preventable infections (Medicare already does this), a strategy intended to encourage hospitals to keep you from getting such an infection in the first place.

In the arena of improving quality, both the Senate and the House version of the bills call for financial incentives to health care institutions to promote efficiency, for example by supporting a “medical home” that coordinates complex patient care. They also call for more research to study the effectiveness of health care services and procedures. This has nothing to do with taking away coverage for useful treatments. If physicians don’t know what works, they can’t treat patients in an optimal way. It’s that simple. And right now there is overwhelming evidence that doctors have routinely used ineffective therapy or have started with expensive and burdensome treatment when less expensive and often less invasive treatment would work just as well, simply because they did not know what would work best.

The bills also contain specific recommendations dealing with prevention that would increase coverage of preventive services under Medicare—for those preventive services that have been shown to improve outcomes. That means many beneficial screening tests that are not currently paid for would be covered in entirety and a few that other covered but that do not improve health would not be. So yes, a few things might be taken away from seniors—tests that are not helpful. But is this being deprived? Why would anyone want to undergo a screening test that doesn’t lead to better health? Knowing sooner that you have a disease just means suffering longer if it does not translate into more effective treatment of the disease.

The Senate and House bills actually include provisions for long term care insurance. Until now, no one in the legislature ever talked about long term care although it is critical to the health and well-being of millions of older people who need home care services or nursing home care. Medicare does not pay for nursing homes, so the 1.5 million people living in nursing homes either pay out of pocket or “spend down” and enroll in Medicaid.

Finally, there are a few miscellaneous provisions in both bills that would affect older people. The House version, for example, would eliminate the notorious “doughnut hole” in the Medicare Part D prescription drug plan, which requires older patients to pay in full for prescription drugs after they have spent $2510 and until they qualify for “catastrophic coverage,” once they have reached a whopping $4350 in out-of-pocket expenditures. The Senate version calls for educational reform to increase the supply, education, and training of doctors, nurses, and other health care workers in geriatrics and primary care.

What’s not to love?

June 19, 2009

Waste Not, Want Not

A recent commentary in JAMA begins with the sweeping condemnation: “An epidemic of waste blights the US health care delivery system.”Sad as this claim is, it is also encouraging, for who wouldn’t want to get rid of waste? Any attempt at reforming American health care should start by eliminating waste—but to do so, we need to know exactly where to find the waste in the system and how best to dispose of it.

Waste comes in several varieties. A RAND study identifies 3 principal flavors: administrative waste (such as excess expenditures on running a health insurance plan); operational inefficiency (for example, duplication of diagnostic tests); and clinical waste (for instance spending money on expensive drugs when cheaper ones would be equally effective).

A good starting point in thinking about reform would be to enumerate all the types of each of these forms of waste and to put a dollar amount on each of them. It turns out that the McKinsey Global Institute, the economics research arm of the McKinsey management consulting firm, has done exactly this kind of analysis.
In fact, McKinsey first undertook to identify where the waste is in the US health care system using 2003 data and then repeated the analysis with 2006 data. What’s fascinating about the report is both seeing where the waste is and discovering how much has changed in 3 short years.

The McKinsey report compares US expenditures on health care with those of a group of 13 countries belonging to the Organization for Economic Cooperation and Development (OECD). Reasoning that richer countries are more willing to spend money on health care, the report computes the Estimated Spending According to Wealth (ESAW), a prediction of how much a given country would spend if it were like the OECD average, adjusted for per capita GDP. In 2006, the US spent nearly $2.1 trillion on health care, or $6800 per person, eating up 16% of GDP. This was an increase of $363 billion since 2003—and $643 billion more than the average spent in the 13 comparison countries (Austria, Canada, the Czech Republic, Denmark, Finland, France, Germany, Iceland, Poland, Portugal, South Korea, Spain, and Switzerland) after adjusting for per capita wealth, or the ESAW

The excess spending produced no discernible health benefit for Americans. In fact, comparisons of the US health care system to that of OECD peers typically find that the US performed worse than everyone else. On one report card, where 1 is the best score and 6 is the worst, the US managed to achieve scores of 5 or 6 on 5 measures: quality care, access, efficiency, equity, and healthy lives.

The waste, according to the McKinsey Report, is in 5 areas: outpatient care ($436 billion or 68% of the excess), drugs ($98 billion or 15%), administrative costs ($91 billion or 14%), investments in health ($50 billion or 7%), and inpatient care ($40 billion or 6%).

By outpatient care, the Report means visits to physicians’ offices, same day surgery, dental care, and treatment in ambulatory surgical centers, diagnostic imaging centers, and other outpatient clinics. What’s striking is that this is the fastest growing component of wasteful care, growing at 7.5% each year since 2003. The higher costs in this sector are due principally to two factors: how much physicians are paid in the U.S. and the high profit margins for ambulatory surgery centers and diagnostic imaging centers. Extremely generous physician compensation adds $64 billion of costs to the system each year. This reflects what we pay specialists and our extravagant use of specialist care: while generalists in the US are paid somewhat better than their counterparts in the comparison countries, specialists are paid much more highly than in the rest of the developed world. Both ambulatory surgery centers and imaging centers are proliferating rapidly, attracted by operating margins of as much as 25%. The result is that the US has 4 times as many CT scanners and MRI machines as the average OECD country, and does 4 times as many imaging studies each year, again with no measurable benefit in terms of patient outcomes.

Drugs are the second major area of wasted spending (this includes both drugs spent by outpatients and drugs spend by hospitals). What’s interesting here is that Americans actually take 10% fewer prescription drugs than the average OECD patient each year. The source of the waste is that drug companies charge on average 50% more for brand name drugs in the U.S. than elsewhere in the world and Americans use a more expensive mix of drugs (a large fraction of brand name or newly released drugs).

Health care administrative costs are next on the list. Most of this relates to operating expenses and profits among private health insurance companies. The American multi-payer system, far from driving down costs through competition, adds costs to the system in the form of marketing, sales, and management overhead. Even Medicare, which until recently had far lower administrative costs than the private sector, has experienced a rise in costs since 2003 because of payments it makes to private plans to administer the Medicare Advantage Plans and the Part D drug benefit.

Investments in health are also higher than in peer countries after adjusting for per capita wealth. This means the US invests more in public health and basic research than other countries. This is one area where the excess, relative to other nations, may well be beneficial and not wasteful. Whether NIH and state public health departments are spending their money in the most effective way—whether they are getting maximum value for their investment—should be carefully examined.

At the bottom of the list, but still a major source of waste, is inpatient care. What’s fascinating here is that both the number and length of hospitalizations are shorter in the U.S. than anywhere else. The waste stems from the cost per hospital day, which is roughly twice the OECD average. This in turn reflects more spending on high tech equipment and subspecialty care.

At least as interesting as the breakdown of the types of waste is the way the distribution has changed in the last few years. The identical analysis by McKinsey using 2003 data found that by far the largest source of waste was inpatient care, accounting for slightly under half of all the waste. Why has the contribution of hospitalization gone from first to last? The mechanism of reimbursement for hospital care by diagnosis related groups, which gives hospitals a fixed amount of money depending on the reason the patient was admitted rather than a per diem rate, has been in effect for older patients since 1983. What has changed is the availability of a more lucrative alternative—day surgery and treatment in ambulatory surgical centers—for the treatment of conditions such as hernias and cataracts. The move from one site of care to another dramatically demonstrates the tremendous adaptability of the health care eco-system.

The implications for health care reform of this type of analysis are profound. If we truly want to decrease wasteful spending, both short term and long term interventions will be required. If we want to manage the flow of procedures from the hospital to the outpatient setting wisely, we need to regulate the proliferation of ambulatory surgical centers and diagnostic imaging centers and to control what they charge for their services. If we want to affect the balance of specialty and generalist care, it will not be enough to provide incentives to medical students to go into primary care: we will need to markedly decrease the phenomenal rate of reimbursement for specialists. If we hope to decrease waste in the medication arena, we will need to determine whether new drugs are better than old ones and if so how much better. We will need to institute some sort of price control over the pharmaceutical industry, at least by negotiating prices (not currently an option under Medicare Part D). And if we truly want to get rid of wasteful administrative costs, we need to consider a single payer system, something that is currently not even on the table as Congress debates health care reform. Finally, we need to recognize that some of what other countries deem wasteful, such as high tech care near the end of life in exchange for a minute chance of life-prolongation, Americans seem to value. If we want to get rid of this type of expenditure, we will need to change the culture that supports this approach, not merely the economic incentives that further facilitate it.

June 02, 2009

Is Death Optional?

Just how far attitudes and expectations about aging have changed in the last 60 years hit home on reading an article from the NY Times Magazine from 1950 called “Recharting Life for an Aging America.” The author, a physician, wrote that “To lead a long and happy life falls, for the average citizen, into the same category of irrational wishes as to be a millionaire or a movie star.” The reality, he said, is that most old people are “lonely, poor, ailing, crippled, ugly, [and] mentally and physically deteriorated.” Today, by contrast, older people take the possibility of ever increasing longevity for granted.

The change in perspective is dramatic and it’s very new: while Americans born in 1950could expect to live far longer than their grandfathers did, most of the improvement in life expectancy was due to decreases in infant mortality. It was only in 1970—5 years after the introduction of Medicare—that 65-year-olds could look forward to a longer period of retirement than any previous generation. By 2005, white men could anticipate another 17.2 years of life and white women 20 years.

Is the result really that Americans today fail to accept that death is inevitable? Or do patients appear to believe that death is optional because physicians seldom discuss life’s final stage and continue to offer treatments, even if they are of little or no benefit?

For all the lip service paid to informed consent and joint physician-patient decision making, older patients seldom understand their likely trajectory with and without a particular treatment. I recently saw a dramatic example of this problem in the course of palliative care consultation at a major teaching hospital in Boston.

The patient was a man in his late 70’s who had been hospitalized with a devastating stroke due to massive bleeding in his brain. He was being kept alive in the ICU with a variety of high tech interventions. The attending neurologist told the patient’s wife that the likelihood of any recovery was very small but that the full extent of his improvement might not be known for months. The doctor held out no hope of a full recovery and expected that if the patient did survive, he would require total care and would have little if any language capacity.

The patient’s wife didn’t think her husband would have wanted life-prolonging treatment if he would be left with profound limitations on his functioning, but she wasn’t absolutely sure. She wondered if she should authorize further vigorous treatment to “give him a chance.”

What quickly became clear to me was that the wife’s conception of what it would be like for her husband over the next two months if she opted for attempted rehabilitation and life-prolonging treatment bore little relationship to reality. She imagined that “going to rehab” would be as benign as taking a daily vitamin pill. I explained to her that after transfer to a rehab facility, he would likely suffer multiple complications such as pressure ulcers or pneumonia. He would probably be shuttled back and forth between the rehab facility and the hospital—and after all that, he would either die or be left extremely debilitated. Once she understood both what treatment would entail and how unlikely meaningful recovery was, she had no further hesitation: the right course of action for her husband was to focus exclusively on his comfort.

In today’s medical world, this kind of discussion is rare. If Medicare patients are to get appropriate care, and if costs are to be controlled, physicians must have such conversations. But since the focus is on life-prolongation throughout a physician’s training, with little attention to maximizing quality of life or to deciding when to stop, medical education will need to change.

Medicare and Medicaid pay just under $10 billion per year to hospitals in the form of General Medical Education funds to train residents. But as the Council on Graduate Medical Education observed in a letter to the Secretary of Health and Human Services in May, 2009, hospitals are not held accountable for how they spend the money. Their concern is with their own labor needs, not with training the next generation of physicians to manage chronic disease. It is time to monitor and regulate the way the federal government’s money is spent and require proficiency in end-of-life discussions along with disease management and care coordination.

Some experts believe that telling patients about the trajectory of illness with different treatment options won’t suffice because patients engage in magical thinking: physicians can lay out the various possible scenarios but patients will gamble that they will be the lucky ones who have the best outcomes. My experience suggests that most patients do respond to realistic discussions about their future, but the way to deal with the minority of patients who might want to try a treatment that has a vanishingly small chance of working is simply not to offer such interventions.

Decisions to take certain kinds of treatment in certain situations off the table should be made at the policy level. This will require holding National Institute of Health consensus conferences to determine a new standard of care for patients with a variety of chronic conditions such as dementia or heart failure in the last phase of life. The Centers for Medicare and Medicaid Services (CMS) will then need to give teeth to the practice guidelines that emerge from such conferences by agreeing to reimburse only for treatment that is consistent with those guidelines.

Perhaps the greatest challenge is that policy makers, who will need to endorse the kinds of changes I am suggesting, share the same expectations of ever increasing longevity as other Americans. A good starting point is therefore to limit treatments that are burdensome, unlikely to be effective, and expensive.

The next step will be to dispassionately analyze interventions that offer only a slight chance of benefit and that are expensive but that are not burdensome to patients. Some devices such as pacemakers have become increasingly acceptable as they have become smaller and implanting them has become safer and less invasive. Likewise, some cancers have become chronic illnesses because of the development of relatively non-toxic, targeted therapy. Patients naturally want potentially life-extending treatment if it comes in the form of a pill, without the nausea, vomiting, hair loss, and bone marrow depression associated with conventional chemotherapy.

Ultimately, policy-makers will have to take into consideration cost-effectiveness in deciding whether CMS will cover such treatments. Far less politically charged are the steps that should be taken immediately: regulating spending on graduate medical education and limiting reimbursement for treatment that comes at a high price to both patients and society without conferring any appreciable benefit.

A modified version of this piece appeared on the Health Care Cost Monitor, a blog of the Hastings Center.

May 27, 2009

Fixing Medicare

The Medicare Modernization Act of 2003 was supposed to bring the Medicare program into the 21st century. It was going to ensure that good health care was a reality for both America’s elderly and its disabled citizens. It didn’t succeed.

The 45 million Americans who are enrolled in Medicare are certainly far better off than the 47 million Americans who have no health insurance at all. Some of them are better off today than they were before the MMA was passed since they now have a prescription drug benefit. In fact, for those elders who are in good health, Medicare is a model program: designed in 1965 to cover acute, time-limited illness, it does that very well. The problem is what Medicare does not do so well. It does not provide coordinated and preventive care for those with chronic illness; it favors institutional over home care; and it offers excellent end of life care only to the minority of patients willing to forgo hospitalization and palliative treatment and to enroll in hospice. And Medicare has no good way to control costs.

When the first of the baby boomers turns 65 in 2010, Medicare costs are expected to reach 3.3% of GDP; they will jump to 6.3% of GDP in 2030 and reach a staggering 8.4% in 2050. Forget all the concern about Social Security—it’s the Hospital Trust Fund, which pays for Medicare Part A, that is on track to go bankrupt. The latest report from the Trustees, hot off the press, projects this will happen by 2017.

What Medicare is best at is treating a disease like pneumonia: the patient gets sick quickly, is hospitalized for at most a week, and then goes home with a prescription for a few days’ worth of oral antibiotics. But Medicare patients today have multiple chronic conditions: the 21% of Medicare beneficiaries with 5 or more chronic diseases account for 68% of all Medicare spending.

Patients with chronic medical problems need a very different model of care. They need a coordinated, integrated approach. Right now one of the few ways to get this kind of treatment is through the Program for All Inclusive Care for the Elderly (PACE), a program for the frailest of the frail--elders who are dually enrolled in Medicare and Medicaid and who are impaired enough to qualify to live in a nursing home to boot. PACE has been very successful not only in keeping such patients out of the nursing home but also at keeping them out of the hospital, while providing high quality care. But the model for addressing chronic disease in the MMA was not the capitated PACE program, but rather “case management,” typically provided by an outside agency that does the medical equivalent of trying to direct traffic by phone rather than through the physician’s office. Not surprisingly, these programs have in general been a disappointment.

Because Medicare is geared towards treatment of acute illness, it is built on hospital-based care, not community care. In 2007, 30% of Medicare spending went to hospital treatment. Much smaller chunks went to skilled nursing facility (SNF) care (5%) and to home care (4%). And there are incentives for patients to be treated in institutions rather than at home. For example, patients must spend three nights in a hospital before going to a SNF, even though some simple problems such as pneumonia could easily be treated in the SNF. Similarly, there is an incentive for patients to move into a nursing home—and be covered by Medicaid—rather than to receive care at home.

One of the jewels in the Medicare crown is its hospice benefit. Enacted in 1982, the hospice benefit allows patients with a prognosis of 6 months or less to receive intensive services focusing on their comfort, care which in 95% of cases is delivered at home. The program has gotten excellent marks from families in satisfaction surveys and in formal research studies.

Hospice grown dramatically: between 2000 and 2007, the number of Medicare certified hospices increased by 41%, and the number of hospice patients doubled from 513,000 to one million. But the problem with Medicare hospice is that it forces patients to make a diabolical choice. In order to qualify for the home care services most patients want at the end of life, they have to agree to forgo treatments that can offer significant palliation. Contemporary medicine can enhance the quality of life for many patients with advanced disease through relatively non-invasive treatments such as oral chemotherapy or blood transfusions. But the reimbursement structure of the Medicare hospice benefit—a fixed per diem rate—simply does not allow for these treatments.

How can Medicare do all these things—and continue to provide acute medical care? Providing additional benefits seems like the last thing the Medicare program should do: the costs of the Medicare program have already been skyrocketing, partly due to the growing number of older individuals, but to a much larger extent due to the insatiable American appetite for health care and the introduction of new, expensive technology. Fortunately, the reality is that while Medicare is failing to provide a variety of services that are critically important for older patients, it is simultaneously providing an enormous amount of care that is useless and in many cases even harmful. In fact, when Medicare patients with a heart attack, hip fracture, or colorectal cancer were followed over a five year period, those living in parts of the country with higher spending on medical care experienced higher mortality.

Medicare routinely pays for burdensome, expensive treatments for patients at the end of life. Similarly, it reimburses physicians and hospitals generously for diagnostic tests and procedures of dubious benefit. And it pays for costly medications and treatments when cheaper, equally effective treatments exist. How can Medicare move from today’s reality, in which it fails to provide all kinds of care it should offer and systematically encourages the use of all kinds of care it should not?

In terms of chronic disease, the secret to success lies within the PACE program, which provides coordinated care within a capitated system. HMOs got a bad name in the 1990s, but the truth is that only when an integrated health care system operates within a fixed budget that we can expect to see appropriate allocation of resources. With respect to new technology, which is the principal driver behind escalating costs in the Medicare program, the trick will be to stimulate innovation without allowing technology to diffuse unchecked.

One solution is to allow cost effectiveness analysis to enter into CMS reimbursement decisions, not as the sole criterion, but along with other ethical principles such as preferential treatment for the most vulnerable. Finally, to provide good end of life care to all Medicare patients who die, not just those who currently opt for hospice, many of whom enroll in the program within days or even hours of death, we need to create a new benefit. This would provide much of what is currently available through hospice but allow for some hospital care and many palliative treatments in exchange for forgoing the most expensive types of care such as major surgery and ICU care.

The current discussions of health care reform have appropriately emphasized the importance of universal access. And right now those over 65 do have access through Medicare—though median out-of-pocket health spending as a percent of income has been rising for older individuals, going from 11.9% in 1997 to 16.1% in 2005, potentially jeopardizing access. But Medicare deserves significant attention as well, both to quality and costs, two goals that are sometimes in conflict. The good news is that truly modernizing Medicare—paying attention to the most important health needs of older individuals and focusing on care that works—can actually improve quality while constraining cost.

This article also appeared in the new Hastings Center Blog, the Health Care Cost Monitor.

April 20, 2009

Follow the Money?

Most Americans have probably never heard of it, but MedPAC is arguably one of the most influential organizations in the health care arena. The Medical Payments Advisory Commission is a non-partisan, independent Congressional agency established by Congress in 1997 to advise on issues relating to the Medicare program. That translates mainly into advice on reimbursement policies, but MedPAC’s mandate also includes addressing access and quality of care.

What is MedPAC and just what does it do? It is comprised of 17 commissioners, including a chairman, who serve staggered 3-year terms. They are appointed by the Comptroller General—another important position that most of us have never heard of. While the 17 members of MedPAC are a distinguished group of professionals who come from diverse fields including medicine, nursing, health policy, and economics, they all have other jobs and could not possibly carry out their mission without a strong staff to do the heavy lifting. In fact, MedPAC’s website lists an executive director, an associate director, a deputy directory, 8 principal policy analysts, 9 senior analysts, 2 analysts, and 2 research assistants, along with miscellaneous other aides and consultants. Based on my experience as a member of the Massachusetts Public Health Council, the supposed seat of health care policy in the state, it is the staff that does most of the work and holds the real power.

The work of MedPAC is evident in its “Reports to Congress,” which appear in March and June of each year, as well as in an annual Data Book. The most recent Report, released in March 2009, all 424 pages of which are available on the web, gives some indication of the breadth and depth of MedPAC’s work. The introduction by Chairman Glen Hackbarth (who incidentally is a founding member of the multi-specialty group practice where I work, Harvard Vanguard Medical Associates), sets the scene. Hackbarth identifies 5 major imperatives for Medicare reform: redesigning and rebuilding primary care, moving beyond fee for service to a more integrated and coordinated model of care, revamping the Medicare Advantage program to reward excellent performance, working to constrain costs by modifying the reimbursement system, and investing in comparative effectiveness research.

To get a flavor of just how far MedPAC goes in its recommendations, consider just 3 of its specific suggestions, those dealing with updating the payment system, revising the Medicare Advantage Program, and modifying the reimbursement system for hospice. Every year, MedPAC tells Congress what changes to make in how much Medicare pays for a variety of services. One of the areas the report addresses this year is payments for expensive imaging services—payments for MRI and CT and PET scan studies. Hidden behind its very dry language, MedPAC does something quite radical: The Commission recognizes that its system for deciding how much to pay for such procedures has been based on the assumption that the equipment is operated 25 hours/week. As a result, providers have an incentive to purchase expensive machinery, even if they have only modest needs, but then to use it as much as possible. The latest report advises modifying the reimbursement formula by assuming that equipment is in operation many more hours each week, thus decreasing the per scan reimbursement and potentially slowing the rapidly rising number of imaging studies ordered each year.

A second area tackled by MedPAC is the Medicare Advantage program. To encourage older individuals to sign up for a private plan rather than the government program, third party payers have been encouraged to come up with capitated plans as alternatives to conventional fee for service Medicare. Some of these plans offer coordination of care and a truly integrated model of health care, which are widely held to be desirable for older patients. Others don’t offer such a comprehensive program but nonetheless receive roughly 14% more from Medicare than do fee-for-service plans providing comparable care. MedPAC wants to make sure that it’s getting value for its money by eliminating what it sees as the windfall offered to capitated programs.

Finally, the report discusses Medicare hospice reimbursement, which has been essentially unchanged since the hospice benefit was introduced in 1982. Between 2000 and 2007, about 1000 new hospice providers entered the market, almost all of them for-profit agencies. The Commission recognizes that many of these hospices are making a sizable profit by enrolling lots of long stay patients: Hospices are paid a fixed per diem rate, so if they care for many low-maintenance patients over an extended period of time, they make money. The new proposal is to pay hospices a higher daily fee initially, when the hospice spends a disproportionate amount of time and effort evaluating a patient and providing whatever medications and equipment the patient needs, then pay a lower fee for intermediate days, and pay a higher fee for the last few days of life, when resource utilization goes up. While this approach is entirely rational as a way to prevent hospices from bilking Medicare by, for example, enrolling nursing home patients with dementia for long periods of time, it has the potential to further discourage hospices from enrolling cancer patients who are interested in pursuing palliative but expensive treatments such as radiation therapy or oral chemotherapy.

MedPAC’s suggestions are based on an extensive analysis of Medicare data—data which are published in its annual data book. They are often very reasonable strategies to improve the existing system of care. But while the Commission has an excellent grasp of the context within which reimbursement occurs and professes interest in developing a correspondingly broad set of recommendations, its concrete proposals tend to deal fairly narrowly with payment issues. The main job of the Commission, after all, is to advise on Medicare payment.

Proposals for reforming America’s health care system are multiplying faster than any other type of innovation in medicine—in fact, I haven’t had written a blog posting in some time because each time I prepare to respond to one plan, another one appears. The New England Journal of Medicine, Health Affairs, and the Annals of Internal Medicine have all featured numerous articles on health care reform. One piece just published this month, emanating from something called the FRESH-Thinking Project, boasts a record 50 authors. Most of these articles, like MedPAC, focus on reforming the reimbursement system. They assume that financial incentives drive medical practice. And they are of course right to follow the money, as Deep Throat famously told journalist Bob Woodward. But important as finances are, and insightful and pragmatic as MedPAC is, there is more to health care reform than modifying the payment system. The payment system is essentially the same throughout the country and yet there is enormous variation in the way medicine is practiced. Very little of that variation is due to differences in how sick people are in New Jersey (the highest spending area of the country) and North Dakota (the lowest spending area). The root cause of variation is differences in the culture of medicine. It is the sociology of medicine that we must understand before turning to MedPAC to implement change in the reimbursement system.

February 12, 2009

A Tale of Two Patients

The primary caregiver for her three grandchildren, 59-year-old Lola Sanchez tried unsuccessfully to go to the kitchen to prepare a snack for the four-year-old and found something was terribly wrong with her right leg. She managed to call an ambulance, but by the time the paramedics arrived, Mrs. Sanchez could no longer speak distinctly and her entire right side was paralyzed. Her blood pressure and her blood sugar were sky high. When she reached the hospital emergency room, she was in a coma. Two days later she was dead, a victim of a massive intracerebral hemorrhage, caused by untreated high blood pressure and inadequately controlled diabetes. Mrs. Sanchez had no health insurance.

In the intensive care unit of the same hospital, Samuel Wang, a 92-year old man with advanced dementia, lay curled up in an ICU bed, dependent on a ventilator to breathe. He had been brought in from a nursing home two weeks earlier with pneumonia. Mr. Wang, who could no longer speak or recognize his family, had aspirated—his food had gone into his lungs, a common occurrence in the final stage of Alzheimer’s disease. Because his family asked the physicians to “do everything” to prolong his life, he remained attached to the ventilator, receiving artificial nutrition through a feeding tube in his stomach. A pacemaker helped keep his heart going. One month after admission, he died after an unsuccessful attempt at cardiopulmonary resuscitation. Mr. Wang was enrolled in Medicare, which together with his supplementary medical insurance, paid the entire $125,000 cost of his hospital stay.

These two scenarios are far from uncommon. According to a recent Urban Institute report, 27,000 Americans died of preventable causes because they lacked medical insurance in 2006. Since most people like Mrs. Sanchez with high blood pressure are asymptomatic, they often do not visit the doctor if they are uninsured. But over the long run, untreated hypertension predisposes to stroke. In the same year, according to researchers at the Dartmouth Institute for Health Policy and Clinical Practice, Medicare spent $10 billion on non-beneficial care for elderly individuals with chronic disease such as Mr. Wang. Expenditures on diagnostic tests, physician visits, and hospitalization are three times higher in some areas of the U.S. than in others, without resulting in any better outcomes.

The current administration hopes to help people like Lola Sanchez by increasing access to care. Access is critical: fully 75 million adult Americans are uninsured or under-insured, resulting in the U.S. coming in last among 19 industrialized nations in the rate of preventable deaths, according to a new analysis by the Commonwealth Fund. But it is irresponsible to improve access, adding to the total government expenditure on medical care, without simultaneously addressing its cost. Currently, Medicare and Medicaid alone account for nearly 5% of GDP and Peter Orszag, Director of the Office of Management and Budget, has projected this will rise to 20% by 2050 unless we take dramatic steps to curb escalating growth.

In the move toward health care reform, cost has received short shrift except to stimulate exhortations to limit waste and inefficiency. Waste—ordering duplicate diagnostic tests because of a lack of an electronic medical record, or prescribing expensive brand name medications instead of far cheaper generic equivalents—makes a modest contribution to spiraling medical costs. The main culprit, according to most medical economists, is the American obsession with high tech medicine. Physicians, patients, and families believe that more is better. The faith in technology is further fueled by device-manufacturers, pharmaceutical companies and the media, as well as by our health care reimbursement system. As health care reform proceeds, we should focus on access, quality, and cost. That will mean using our technology selectively in those who have a reasonable chance of benefiting. It will mean changing the medical culture to ensure that patients nearing the end of life do not routinely undergo pacemaker insertion and are not regularly admitted to the ICU, but instead receive competent and compassionate palliative care.

January 02, 2009

Movies, Restaurants, Hotels—and Now Nursing Homes

With considerable fanfare, the Centers for Medicare and Medicaid Services (CMS) released a new rating system for nursing homes in mid-December. Depending on your perspective, the state where I live, Massachusetts, either did very well—it was among the top 10 states in the US—or not so well—it has a lower percentage of five-star and a higher percentage of one-star nursing homes than neighboring New Hampshire, Connecticut or Maine.

All rating systems are subject to criticism and this latest one is no exception. For some time, CMS has published Nursing Home Compare, which allows consumers to see how a particular nursing home scores using a variety of indicators. The new approach tries to boil down all the assessments to a single summary statistic. That statistic (the number of stars) in turn depends on just three measures: the result of health inspections, the staffing ratio, and a quality measure. Arguably the most important—and controversial—of these is the quality measure. For long stay nursing homes, the rating system uses 7 different measures to come up with its rating, ranging from the percent of residents who report untreated pain (a good measure but dependent on self-reporting by the facility) to the frequency of urinary tract infections (of dubious importance as many nursing home residents have bacteria in their urine that is of no significance). For short stay facilities (rehab or post-acute care), the rating system uses only 3 different measures to derive its composite quality rating: the presence of acute confusion (delirium), pain, and pressure ulcers. None of the three is corrected for the severity of illness of the patients in the facility. It’s not clear to me that this simplified rating system is an improvement over the previous more nuanced reports. But what is indisputable is that nursing homes in Massachusetts vary enormously. Facilities awarded five stars are probably pretty good and those with one star are probably pretty poor. What, then, should the state do to promote better quality?

The prevailing approach to ensuring quality relies on an extensive system of federal regulations that are enforced by the state Department of Public Health. Teams of surveyors make unscheduled inspections to determine whether facilities are in compliance with the regulations and issue citations for any “deficiencies.” The results of these surveys are public and may result in penalties ranging from fines to loss of Medicaid and Medicare certification. Nursing home quality has improved over the past 10 years, and the regulations probably played a role in stimulating change, particularly when combined with a mandatory resident assessment system, but clearly there is more work to be done.

How should Massachusetts promote further improvement? Perhaps it is time to move from a punitive system to one that offers incentives for achieving quality. An interesting experiment that bears watching is underway in Minnesota, which has introduced pay-for-performance into nursing homes. But pay-for-performance tends to encourage institutions to concentrate only on those areas in which they know they will be measured, to the detriment of other areas. And by rewarding facilities for outcomes rather than for improvement, they decrease reimbursement to precisely those sites that need an infusion of funds to improve.

Over the long run, Massachusetts can hope to improve nursing homes by making a career in long-term care attractive. Physician interest in nursing home care has grown, though modestly: medical directors of nursing homes now have their own professional society and an academic journal. Nurse practitioners are playing an increasing role as primary care clinicians in the nursing home, where they have contributed to better medical care and decreased hospitalization rates along with a high degree of family satisfaction.
The last frontier is the nursing assistant, who continues to be poorly paid, to have limited opportunities for advancement, and to suffer from high rates of job-related injury.

The Massachusetts Act to Promote Cost Containment, signed into law in August, 2008, commits the state to a major effort to attract primary care physicians and nurses through enhanced educational opportunities and loan forgiveness programs. We need to broaden that initiative by developing a career ladder for nursing assistants, creating a variety of positions between the Certified Nursing Assistant (who typically receives 75 hours of classroom training and 100 hours of on-the-job training) and the Registered Nurse (who may have spent 4-5 years getting a Bachelor of Science in Nursing). Only when all those caring for nursing home residents take pride in their work, when they receive respect for what they do and have autonomy in their jobs, can we expect both quality of care and quality of life to improve in nursing facilities.

A shorter version of this posting appeared on Commonhealth