Massachusetts Health Care Reform--Act 2

Why isn’t everyone talking about the new Massachusetts Health Care Reform law? Is it that the Governor signed the legislation into law during the dog days of summer? Is it that the act, which introduces cost containment measures and quality improvement measures, isn’t a single issue bill like the first health care reform law, which expanded coverage to almost all Massachusetts residents?
The “Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care,” (S2863) is an important piece of legislation which should be getting a great deal more local and national attention than it has. But for all its virtues, it also has some major flaws—and it won’t make much of a dent in the skyrocketing cost of health care.
The law calls for two new programs: a pharmacy drug detailing program and a health care workforce center. The detailing program is modeled on an intervention proposed by Harvard researchers Jerry Avorn and Stephen Soumerai 25 years ago: they wondered whether the same kind of clever strategies used by drug companies to promote their wares could be used to provide physicians with accurate information about the safety and cost-effectiveness of drugs by using trained pharmacists as “un-sales reps.” Their 4-state randomized trial found that academic detail men were accepted by the overwhelming majority of physicians—and that the program saved $2 for every $1 in costs (Jerome Avorn and Stephen Soumerai, “Improving Drug-Therapy Decisions Through Educational Outreach. A Randomized Controlled Trial of Academically Based ‘Detailing,” New England Journal of Medicine 1983; 308: 1457-63). With the new health reform law, the Massachusetts Department of Public Health has been charged with arranging face to face visits to “inform prescribers about drug marketing intended to circumvent competition from generics.” How effective this strategy will be in 2008 is unclear, now that drug companies are not only targeting physicians but are also pouring money into direct-to-consumer advertising.
The law also calls for the establishment of a Health Care Workforce Center whose main purpose is to increase the number of primary care physicians in the state. Specifically, the program will set up a loan repayment program for doctors who go into primary care. A related part of the bill requires the University of Massachusetts Medical School to increase its enrollment, to add residency slots for primary care, and to waive tuition for applicants who agree to practice in under-served areas. Taking steps to enhance primary care is laudable, but as demonstrated in the recent Institute of Medicine Report, Retooling for An Aging America: Building the Health Care Workforce (see my blog entry, “the Boomers are Coming, the Boomers are Coming,” from May 9, 2008), what we desperately need is not just primary care physicians and nurses, but also a diverse array of individuals equipped to care for our growing geriatric population.
One of the few provisions of the new law that did garner quite a bit of attention is the “gift ban,” which requires health care providers to publicly report any gifts they receive from pharmaceutical or medical device manufacturing companies and which bans certain kinds of gifts altogether. Drug companies protested loudly, but as Dr. Jerome Kassirer argued in his book, On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Life ( NY: Oxford University Press, 2005), the standards promulgated under the law constitute are not radical or draconian: they simply represent a basic, ethically justifiable set of guidelines for corporate and professional conduct.
Massachusetts Health Reform, Act 2 contains a hodgepodge of other provisions designed to improve quality and efficiency of care. It requires hospitals to develop rapid response teams for “deteriorating patients,” a measure that could lead to the installation of “panic buttons” in every patient room—not necessarily a good idea. The concerns of families need to be respected and addressed, but surely it should be professional judgment and not anxious families that dictate the summoning of an emergency response team. The act will require hospitals to implement computerized physician order entry systems by 2012 and electronic medical records by 2005—which is probably a good thing, but not as well-supported by hard evidence as I would like. As Drs. Pamela Hartzband and Jerome Groopman argue in their essay, “Off the Record: Avoiding the Pitfalls of Going Electronic” (New England Journal of Medicine 2008; 358: 1656-8), electronic medical records can “constrain creative clinical thinking” and computers can “become a barrier between patients and physicians.” And the act calls for new initiatives in end of life care and in home care—laudable but at this point vague and without substance.
All these components of the new law focus on improving the efficiency and quality of medical care. The only measure that seeks to control costs by actually changing the way we do things in medicine, not merely by ensuring that we do what we have been doing but with greater efficiency, is the requirement that physicians wishing to build ambulatory surgery centers apply for and receive a “Determination of Need” certificate. The engine that drives costs is technology and right now hospitals and medical groups can build new outpatient centers for doing procedures with essentially no restrictions. And in medicine, if you build a new machine, it will be used, regardless of whether one more scanner or surgical suite actually improves the population’s health. Dr. John Wennberg of Dartmouth, who has devoted his career to the exploration of regional variations in American health care, has found repeatedly that the number of elective procedures in various parts of the country depends not on need but on the capacity to perform those procedures (see for example John Wennberg and Alan Gittlesohn, “Small Area Variation in Health Care Delivery,” Science 1973; 182: 1102-8). Controlling the untrammeled growth of technology by evaluating the need for the centers that house that technology has the potential to have an enormous effect on the future cost of medical care. The caveat is that the legislation needs to have teeth, and it is unclear how the requirement that ambulatory surgical centers demonstrate “need” will play out: how is “need” to be defined and measured? Will the cost of the center be a consideration or if there is “need” (read “demand”), is any cost acceptable? Unfortunately, current Massachusetts Determination of Need regulations for hospitals include no such considerations.
Massachusetts Health Care Reform—Act 2 is an important step in the right direction. But if we want to truly change the way health care is delivered and provide high quality care at an affordable cost, we better start working on Massachusetts Health Care Reform—Act 3.

"F" is for Failure

Federal Reserve president Ben Bernanke stood in front of the Senate Finance Committee a month ago and delivered some bad news: the cost of health care is spiraling out of control. And costs will continue to “rise relentlessly,” he said, unless Congress substantially overhauls the health care system (Robert Pear, “Fed Chief Addresses Health Care and Its Cost,” New York Times, June 17, 2008), which it has shown no inclination to do.

At the same time, Bernanke pointed to two other problems with U.S. health care: access and quality. It is these two areas that get most of the attention from lawmakers. Just how poorly the U.S. is doing in these two domains was emphasized yet again in a report released last week by the Commonwealth Fund. The results of the “National Scorecard on U.S. Health System Performance, 2008” are shockingly poor. Lumping all 37 indicators of quality devised by the Fund into one measure, the U.S. scored a 65 out of 100 (down from 67 in 2006). (“Why Not the Best? Results from the National Scorecard on U.S. Health System Performance, 2008,” available at www.commonwealthfund.org.) I'd call that a failing grade.

In terms of access, the average score was 58, with 75 million working age adults—42% of the population—either uninsured or underinsured, up from 61 million (35%) in 2003. The direct consequence of lack of coverage is that the U.S. is now in last place among 19 industrialized nations in terms of deaths that could have been prevented with timely and effective care. In terms of quality, only 41% of adults with hypertension were adequately treated—and only 21% of those with hypertension who had no health insurance.

What continues to get relatively little attention is Bernanke’s first point, the high cost of health care. The Commonwealth report notes that the U.S. spends twice as much per capita as other major industrialized countries on health care, though it fares worse on virtually all outcome measures. Even within the U.S., higher levels of spending often translate paradoxically into lower quality care: among Medicare patients treated for heart attacks, hip fractures, or colorectal cancer, the regions of the country with the lowest mortality rates also had lower total costs.

The presidential candidates say laughably little about health care costs. A side-by-side comparison of their statements on health care reveals only a few points about cost. The democratic and republican proposals are limited, unimaginative—and remarkably similar (see the analysis by the Henry J. Kaiser Family Foundation, “2008 Presidential Candidate Health Care Proposals: Side-by-Side Summary,” at www.health08.org.)

Both Obama and McCain advocate malpractice reform and greater competition among insurance plans. Both candidates allude to the high cost of prescription drugs and favor encouraging the use of generics, and both talk in general terms about the need for increased attention to preventive care and the treatment of chronic conditions. These are all important issues but they will not solve the problem of the high cost of care. Obama specifically advocates investing in electronic medical records and health information technology (to improve efficiency) and McCain wants to give consumers more information about treatment options (in the naïve hope that they will choose less expensive care). But neither talks about the real culprit—the excessive use of high cost technology, even when it is of little or no benefit (see for example Kenneth Thorpe et al, “Which Medical Conditions Account for the Rise in Health Care Spending? Health Affairs, August 25, 2004).

The New York Times, by contrast, is finally beginning to understand the role of technology in driving up the cost of medical care. Over the last month, the Times has featured an article about the use of Avastin (Bevacizumab), a form of chemotherapy costing as much as $100,000/patient/year (Gina Kolata and Andrew Pollack, “Costly Cancer Drug Offers Hope, But Also a Dilemma,” New York Times, July 6, 2008) and another article about the use of an implantable defibrillator in a 99 year old woman (Anemona Hartcollis, “Rise Seen in Medical Effort to Treat the Very Old,” New York Times, July 18, 2008). But both articles wistfully conclude that we are facing a heart-rending dilemma, what the journalists view as an insoluble conflict between the legitimate wish of sick patients to get better and the societal need to constrain costs.

In fact, there is a perfectly reasonable solution: physicians should be restricted in their use of expensive technology to situations in which it has been demonstrated to be beneficial; and Medicare should set reimbursement for high tech interventions at a level reflecting their cost-effectiveness. In the case of Avastin, for example, it may be rational to prescribe the drug for those forms of cancer for which it has been shown to be beneficial, even when the benefit is the prolongation of life by only several months, but not for other forms of cancer for which efficacy is entirely speculative. Moreover, Medicare should set reimbursement at a rate commensurate with benefit, as is done in Australia. When this has been done in the U.S., as when the Centers for Medicare and Medicaid set the reimbursement rate for the left ventricular assist device (an invasive, expensive, but occasionally modestly effective means of treating advanced heart failure) well below the manufacturer’s charges, the rate of use stayed very low. In the case of the defibrillator/pacemaker, which in the Times example was inserted to prevent symptoms of dizziness and weakness, it would have sufficed to implant a pacemaker (cost $11,712 in FY 2005). There is no need to deprive a patient of an effective treatment that will ameliorate symptoms simply to control costs. The problem is that the patient was given a combination defibrillator/pacemaker, a sophisticated device intended to prevent sudden death as well as to counteract a low heart rate—more than doubling the cost ($28,442 in FY 2005) without conferring any advantage in terms of quality of life. The total annual spending on implantable defibrillators in the U.S. is over $1 billion/year, some of which is clearly beneficial, but some of which is not.

Improving access and quality, while tremendously important, will just exacerbate the cost issue if we tackle them without simultaneously addressing cost. It is time for Congress, the Administration, the presidential candidates, and the American people to stop burying their heads in the sand. U.S. health care just got a failing grade: if you sent your child to an expensive private school and he came home with F’s and D’s on his report card, would you blithely and unquestioningly continue to fork out exorbitant tuition payments because the headmaster assured you the school was the best in the world?

The Boomers are Coming, the Boomers are Coming

I often wonder just how many billions of dollars Americans spend every year on producing reports. Think tanks, government agencies, and academic departments, not to mention corporations, are forever releasing reports. Most of them are filed away, largely unread, certainly unheeded. Every so often a report actually has a major impact—on policy, on behavior, or on public understanding. The Surgeon General’s Report, The Health Consequences of Smoking, first released in 1971, led to a campaign to promote health by quitting smoking. As a result, per capita cigarette consumption is down in the U.S., as are the incidence of lung cancer and the death rate from heart disease, the primary diseases attributable to smoking.

Several weeks ago, the Institute of Medicine released a new report, Retooling for an Aging America: Building the Health Care Workforce. With luck, this will be one of those reports that triggers a response, but given its low key presentation, unsexy topic, and unpopular message, I fear it will be ignored.

Written in the non-inflammatory, academic style of the IOM, Retooling quietly argues that if we are to provide high quality care for the baby boomers in their old age, we need to geriatricize both health care professionals and personal caregivers. In an equally subdued voice, the report’s writers also conclude that we need to overhaul our entire approach to medical care. They’re right. I hope someone is listening.

The first of the 78 million baby boomers will turn age 65 in 2011. When the last baby boomer turns 65 in 2030, “older adults” will make up 20% of the population, up from the current 12%. Unless we find a cure for Alzheimer’s disease in the immediate future, which is extremely unlikely, and unless we can prevent or cure osteoarthritis, diabetes, and vascular disease, the boomers will develop all these problems in phenomenal numbers. Although they will be healthier than their counterparts a decade ago, many will eventually develop multiple medical problems and will need both health care and personal care if they are to hope to have a reasonable quality of life.

What the new IOM report tells us is that we do not have enough physicians, nurses, social workers, and physical therapists with special expertise in taking care of older adults to handle this enormous wave. We do not have enough home health aides and other personal care attendants to assist older people with basic “activities of daily living” such as dressing, bathing, and eating, given that we can expect that in 2030, over 9 million people will need this kind of help (that’s based on another important report, this one by Robert Friedland, writing for the Georgetown University Long-Term Care Financing Project in 2004: Caregivers and Long-term Care Needs in the 21st Century: Will Public Policy Meet the Challenge?) And informal caregivers—the family members and friends who provide the bulk of the care to frail older Americans—are already overwhelmed physically, emotionally, and financially by their responsibilities.

Retooling for an Aging America tells us very clearly what steps we need to take to begin to fix this problem. It uses the bland language of “increasing recruitment and retention” of personnel, but quickly gets to the central issue: few people are going to jump at the chance to take care of the elderly, whether they be physicians, nurses, or home health aides, unless they receive appropriate recognition, social and financial, for their work. That means compensation needs to go up—a lot. Currently, geriatricians earn on average less than the primary care physicians who see a more diverse population of adults, who in turn earn far less than gastroenterologists or cardiologists. Taking care of frail older people takes extra time, it requires coordination of multiple services, and it necessitates discussions with family members, all of which are reimbursed poorly or not at all. The suggestion that public and private payers provide financial incentives to increase the number of geriatric specialists in all health professions is key. So too is the recommendation that professionals with special expertise in geriatrics receive enhanced reimbursement, though given budgetary constraints, it seems more plausible that physician incomes will need to be redistributed than that payment to those on the bottom end of the totem pole will rise. Similarly, aides who provide hands on care for older people are among the most poorly paid workers in our society, they have the highest rates of on the job injury, and they have few opportunities for advancement. Without better wages, adequate fringe benefits, and an attractive career ladder, it’s hard to imagine the situation will change. The recommendation that state Medicaid programs increase pay and fringe benefits for direct care workers and establish wage floors is an important first step. It does not, however, go nearly far enough, and is not as sweeping as another report that is probably already collecting dust—the study prepared by the much maligned President’s Council on Bioethics in 2005, Taking Care: Ethical Caregiving in Our Aging Society.

It is in the arena of “redesigning models of care” that the report is at its most radical. It begins with the tepid comment that “care that is currently provided to older adults often falls short of acceptable levels of quality.” Then it heats up a bit, acknowledging that the vision of health care services it proposes represents “a major departure from the current system” that will require changes in the ways services are “organized, financed, and delivered.” The report recommends three fundamental changes: care must be comprehensive, it must be efficient, and it must rely on the active participation of older adults.

By comprehensive care, the report means that our current fragmented system has to go. Right now, Medicare doesn’t have an incentive to provide home care because it would be cheaper for patients to go into a nursing home (paid by Medicaid or private funds) than it is for patients to stay at home and have a visiting nurse and physical therapist (paid by Medicare). Today, physician practices shy away from using multidisciplinary teams, the backbone of good geriatric care, because this kind of care is inadequately compensated. Comprehensive care means including both acute care and long term care (at home, in assisted living, and in nursing homes--currently the stepchild of the American health care system) under one umbrella.

By efficient care, the report means that we need to create seamless transitions between the sites where older people receive health care such as the office, the hospital, the skilled nursing facility, and the home setting. This will require better systems of communication and widespread adoption of a single electronic medical record.

By active participation, the report implies that effective management of chronic diseases—and almost a quarter of Medicare beneficiaries have at least 4 chronic diseases—requires self-management. Given that many older patients cannot, by themselves, engage in self-management, a more realistic recommendation would be the involvement of families in all aspects of health care.

So far, Retooling has been written up in the Wall Street Journal and the LA Times but not, as best I can determine, in the New York Times or the Washington Post. This mild-mannered report, which makes reasonable suggestions but says little about how its recommendations might be implemented (or paid for) could well be destined for the dustbin. Let’s hope not. We really need to do something to prepare for the baby boomers, and we need to start now. Write your congressman. Whisper in the ear of the presidential candidates, who have said little or nothing about long term care. Act now.

Don't Look Back

For 35 years, the Dartmouth Atlas of Health Care has been publishing startling data on regional variation in the amount of money spent on medical care in the U.S. It has consistently shown—and the newest version of the Atlas, released this month, is no exception—that Medicare spending on chronically ill patients during the last 2 years of life varies enormously across states (Dartmouth Atlas of Health Care 2008, www.dartmouthatlas.org.) . In recent years, for example, California spent $57,914/patient compared to Iowa, which spent $33,864/patient in the 2 years before death. When the brains behind the Atlas looked at what all the extra money is spent on in “high expenditure” states like California, they found that it’s not spent on effective care (interventions that have been shown unambiguously to be beneficial) and it’s not spent on preference-sensitive care (treatments that some patients select while other patients choose other equally effective treatments with a different side effect profile). Rather, it is lavished on supply-sensitive care: services whose supply determines utilization, without any clear-cut benefit. In states like Massachusetts, for example, with a disproportionately high number of specialists and lots of technology, patients have correspondingly more doctor visits with specialists and receive more high tech diagnostic tests.

It’s not that some areas have more specialists and fancy equipment per capita because they have a higher percentage of sick people in the population. When age and gender are taken into consideration, the rates of illness in California and Iowa are remarkably similar. California just has more medical resources per person, so it devotes more resources to the care of Californians. As a result, patients with chronic illness in some parts of the country spent 6 days in the hospital during their last 6 months of life, while patients in other regions spent 22 days.

The critical question is whether there is any added value to the extra expenditures, and if so, is it worth the additional cost? The creators of the Dartmouth Atlas say there is no additional value, since all the patients they studied died, regardless of what was spent on them.

But this analysis looks only at chronically ill patients who died and then asks what kind of care they received in the 2 years before their deaths. There’s a problem with looking back in this way. The problem is that 2 years before they died, their physicians did not know they were going to die. The real question is, did those chronically ill patients who lived benefit from all the extra medical care they got? What we need to do to answer this question is to study a group of chronically ill patients in a high roller state like New York and the same number of comparable patients in a low spending state like North Dakota. Some of these people, if followed for the next two years, will live and some will die, no matter how much is expended on them. After two years have passed, we can determine not only what fraction lived in each of the two states, but also what happened to the ones who lived. Did they live longer in New York than their counterparts in North Dakota? Was their quality of life any better? If neither those who lived nor those who died benefited from all the additional resources devoted to their care, then clearly New York was spending too much. But if some people benefited, even if others did not, then the issue is more complex. It’s complicated further if those who lived benefited but those who died were made worse off because of the resources spent on them—if they underwent painful procedures and spent a great deal of time in the Intensive Care Unit. In either case, we need to come up with a way—cost-effectiveness analysis is an example—to decide whether we derive sufficient value from the added money spent to make it worthwhile.

To be fair, the creators of the Dartmouth Atlas perfectly well recognize the desirability of looking forward instead of backwards. An important study carried out by this group based on data from 1993-1995 and published in 2003 did exactly that. Elliott Fisher, David Wennberg, and their colleagues studied a group of patient hospitalized for either a hip fracture, colon cancer, or a heart attack, as well as a large representative sample of other Medicare patients. They then asked what happened over the next 5 years: within each group, was there any difference in mortality, in functional status (the ability to care for oneself), or in patient satisfaction, depending on how much money was spent on medical care? What they found was that those people who lived in regions with the highest spending received 60% more medical care than those with the lowest level of spending, with no differences in outcomes (Elliott Fisher, David Wennberg, Therese Stukel et al, “The Implications of Regional Variations in Medicare Spending. Part 2: Health Outcomes and Satisfaction with Care,” Annals of Internal Medicine 2003; 138: 288-298). But this study relies on data that’s 15 years old, and it’s just one study. I think it’s very likely that the regional differences in expenditures uncovered in the 2008 Dartmouth Atlas similarly do not translate into benefit for patients—neither for those who lived nor for those who died. But we could be far more confident in this result if we conducted more studies that looked forward instead of back.

If the conclusions of the Dartmouth Atlas are correct, we need to put a stop to the endless proliferation of sub-specialists, of expensive diagnostic equipment such as PET scanners, and of facilities such as outpatient surgical centers. We should instead identify what medical interventions truly make a difference and limit the supply of those that do not.

Do No Harm: New Data on Dementia

At 43 pages, the newly released report from the Alzheimer’s Association, “Alzheimer’s Disease Facts and Figures.” is 50% longer than last year’s report and every bit as alarming ( www.alz.org/national/documents/report_alzfactsfigures2008.pdf). Today, 5.2 million Americans have Alzheimer’s disease. By 2050, between 11 million and 16 million people will be afflicted unless medical science finds a way to prevent or treat this progressive, ultimately fatal brain disease.

To its credit, the report shies away from hyperbole. Under the heading of treatment and prevention, the authors state unequivocally: “No treatment is available to delay or stop the deterioration of brain cells in Alzheimer’s disease.” They add that while the FDA has approved five drugs for the treatment of Alzheimer’s, these drugs “temporarily slow worsening symptoms for about six to 12 months, on average, for about half of the individuals who take them,” hardly a ringing endorsement for pharmacologic treatment.

Recognizing that one of the major challenges in providing for individuals with dementia is who will take care of them, the report features a major section on family caregiving. Close to 10 million family members, friends, and neighbors provide unpaid care for a person with dementia in the U.S. today. All told, they contribute an estimated 8.4 billion hours of care per year. The impact on the caregivers’ emotional well-being, health, employment, and financial security is considerable. The need for caregivers—paid and unpaid, family and professional—is reaching crisis proportions. The report only hints at the magnitude of the problem (see the President’s Council on Bioethics, Taking Care: Ethical Caregiving in Our Aging Society, 2005, www.bioethics.gov/reports/taking_care/taking_care.pdf)

But the most striking statistics in this number-laden report are those relating to hospitalization rates—and costs—for individuals with dementia. Medicare beneficiaries over age 65 with dementia are 3.4 times more likely to be hospitalized each year than are their non-demented counterparts. Looked at differently, this means that 25% of older patients in American hospitals at any point in time have dementia. Not surprisingly, annual Medicare costs for those with dementia are high: $13,207 per person compared to $4,454 per non-demented person. This discrepancy is directly attributable to the disproportionately high rate of hospitalization. But not only are people with dementia at high risk of hospitalization, once they’re in the hospital, they cost Medicare 3.2 times more than other patients: they have more complex diseases, undergo more procedures, and stay in the hospital longer.

The data on hospitalization rates are extraordinary because it is far from clear that it makes sense to subject individuals with dementia to frequent and lengthy hospitalizations. The more advanced their dementia, the more frightening the experience of being in a strange place, cared for by a new and unfamiliar nurse every eight hours—and the less they have to gain. In one study of survival after hospitalization, for example, 55% of patients with dementia and a hip fracture were dead in six months, compared to 12% without dementia treated for a hip fracture, and 53% of patients with dementia and pneumonia were dead in six months, compared to 13% of those without dementia treated for pneumonia (RS Morrison, A Siu, “Survival in End-Stage Dementia Following Acute Illness,” Journal of the American Medical Association 2000; 284: 47-52). These uncomprehending patients who are near the end of their lives endure intravenous injections, nasogastric tubes and other uncomfortable and scary procedures in exchange for a small chance of living ever so slightly longer in their demented state (S Mitchell, D Kiely, and MB Hamel, “Dying with Advanced Dementia in the Nursing Home,” Archives of Internal Medicine 2004; 164:321-6). Surely the burdens of invasive treatment outweigh the benefits. A palliative approach to care, focusing on comfort rather than a misguided attempt to increase longevity, makes sense.

The report concludes by noting that the lifetime risk of developing dementia is 21% for women and 14% for men, assuming they live to be at least 55. A low fat diet, rich in fruits and vegetables, may attenuate these stark numbers slightly, as may a vigorous social network. Research into drugs and vaccines to delay the onset of dementia or treat the disease once it develops is thriving and may yet produce a magic bullet that dramatically alters the odds of dying of dementia. But in the mean time, we need to overhaul the prevailing approach to the care of individuals who have this devastating disease. It’s one of the few areas of medicine in which doing the right thing actually has the potential to save money.

MiniClinics on the March: Politics, Policy, and the Public's Health

In the ten months that I have served on the Massachusetts Public Health Council, no issue has been more contentious than “limited service clinics,” quickie drop-in offices offering treatment of minor illnesses that will be located primarily in pharmacies and staffed by nurse practitioners. The 15-member council, which is empowered to help shape health care policy in Massachusetts, has approved expensive new scanners, multi-million dollar outpatient buildings, and the creation of additional hospital beds with scarcely a whimper of protest. Many of these capital expenditures will predictably drive up health care costs in the state of Massachusetts, potentially threatening outlays for services essential to the health and well-being of the citizens of the Commonwealth. The benefit accruing from these capital investments is not subject to scrutiny.

The regulations that will permit the introduction of limited service clinics in Massachusetts, by contrast, provoked a storm of protest. Council members were deluged with petitions from interested parties—primarily physician groups arguing against this form of medical practice. The Council spent the better part of two of its monthly meetings debating the issue. But was the issue really the regulations—the Department of Public Health did an admirable job of developing detailed regulations that conformed to the proposed regulations developed by the American Academy of Family Physicians—or rather the belief of a variety of interest groups that mini-clinics are dangerous because they offer episodic care rather than coordinated care, they will be staffed by nurse practitioners rather than physicians, they will tend to be for-profit, and many will be located in drug stores, which sell cigarettes. Do any of these concerns hold up?

Nothing but the best…
Ideally, if you live in Massachusetts, you have your own primary care physician. Not only that, but you have ready access to that physician—no week-long waits for an appointment, no 2-hour waits to be seen even if you have an appointment. In the best all of all worlds, if you are elderly and have multiple chronic illnesses, you have coordinated care, facilitated by a case manager (see R. Bernabei et al, “Randomised Trial of Impact of Model of Integrated Care and Case Management for Older People Living in Community,” British Medical Journal 1998; 316: 1348-1352). You also have health insurance coverage to pay for your visit to the physician. And if you happen not to be a resident, but merely visiting the state, you are able to find a primary care practice ready and willing to accommodate you if you happen to get sick while you’re here.

The reality is very different. Massachusetts has a shortage of primary care doctors. Generalists don’t want to move to the state, where salaries are below the national average and the cost of living is well above the national average. Despite the recent initiative to require health insurance for all residents, not everyone has coverage. “Coverage” may include substantial co-payments and deductibles. Thousands of patients throng to emergency rooms for care every day—where the wait to be seen is usually measured in hours, not minutes.

The fix for these problems is complex. And it’s not a problem that Massachusetts can solve alone—nation-wide, primary care is in a slump. The number of young physicians going into primary care is declining every year, and the reasons range from high student loans to fear of litigation, with a dozen other factors in between that adversely affect physicians’ willingness to practice general medicine.

Over the short term, limited service clinics can help. They provide an alternative way for patients to get treatment for straightforward problems such as sore throats and sprained ankles. They can administer flu shots and help tourists with a rash or a stomach bug. With suitable regulatory oversight, mini-clinics can improve the public’s health.

The NP/Physician Wars
Physicians have been suspicious of the care provided by nurse practitioners for years. But the evidence is that in the arenas where NPs work, they often do at least as good a job as physicians. A study by Mary Mundinger et al (“Primary Care Outcomes in Patients Treated by Nurse Practitioners or Physicians: A Randomized Trial,” Journal of the American Medical Association 2000; 283: 59-68), found no differences in outcomes or satisfaction among over 3000 adults, some of whom received care from NPs and some from MDs—except in the case of management of high blood pressure, where NPs performed better. In data specifically on limited service clinics released as part of the Minnesota Health Care Quality Report, the NP-run clinics received a 100% rating for the treatment of sore throat in the pediatric population in 2006. When I randomly chose a not-for-profit clinic operating in the same Minnesota county to compare to Minute Clinic, I found it had a 72% rating on the sore throat treatment indicator (see mnhealthcare.org).

NPs always have MD back-up and supervision. It’s a condition of their licensure. But that doesn’t mean a doctor must be on the premises. NPs have been providing high quality care in nursing homes (where doctors often fear to tread) for years, as well as in hospices and in patients’ homes. There is no reason to worry they will misdiagnose or mistreat the routine ailments that will come to their attention in mini-clinics.

Big bad for-profit health care…
Many health care institutions throughout the United States are for-profit. There are for-profit HMOs, for-profit hospitals, and for-profit physician group practices, among others. The data on the effect of for-profit status on the quality of care is mixed. A National Bureau of Economic Research Conference Report comparing for-profit hospitals to not-for-profit hospitals found evidence that in some situations, for-profit hospitals are higher quality than not for profit hospitals (David Cutler, ed, The Changing Hospital Industry: Comparing Not-for-Profit and For-Profit Institutions, Chicago: University of Chicago Press, 2000). On the other hand, a study comparing health plans found for-profit plans performed less well than not-for-profit plans on 3 out of 4 quality indicators (EL Schneider et al, “Quality of Care in For-Profit and Not-for-Profit Health Plans Enrolling Medicare Beneficiaries,” American Journal of Medicine 2005; 118: 1392-1400).

For-profit health care is no stranger to Massachusetts. We have for-profit nursing homes. We have for-profit hospices. There is no justification for dismissing limited service clinics simply because many of them will be owned and operated by CVS.

It’s an outrage to have a health care clinic within a facility that sells cigarettes…
Cigarettes are one of the leading causes of some of the major killers: coronary heart disease, emphysema, and lung cancer. Clearly, the Massachusetts Department of Public Health needs to be concerned with strategies to decrease cigarette smoking and to prevent young people from starting to smoke in the first place. But we do not ban the sale of cigarettes outright. We do not tax cigarettes enough to make them unaffordable to all but the very rich. And we do not prevent drug stores that sell prescription drugs for the treatment of coronary heart disease, emphysema, and lung cancer from also selling cigarettes. I fail to see why we should prevent those same drug stores from housing a health clinic.

The bottom line
I hope that some day all patients in Massachusetts have access to top notch primary care. In particular, I hope that frail geriatric patients will have the kind of integrated care that I believe is best achieved through a case-managed, capitated health plan. In fact, I hope that there will be so little demand for mini-clinics that they disappear. But for the moment, I suspect they will provide a valuable service for many sick people in Massachusetts.

It is time for policy makers to pay at least as much attention to the rising cost of health care and its potentially dire consequences as to mini-clinics. Just this morning the Boston Globe reported that Governor Patrick has proposed a $28.2 billion budget that includes a 1.3 billion dollar budget gap, “created mainly by rising health care costs and decreased revenues.” The Congressional Budget Office recently released statistics indicating that barring any changes in policy, total spending on health care, which currently accounts for 16% of the Gross Domestic Project, will rise to 25% in 2025 and 37% in 2050. Federal spending on Medicare and Medicaid alone (net of beneficiaries’ premiums) is now 4% of GDP and will rise to 7% in 2025 and 12% in 2050 (see www.cbo.gov). Medicaid is a joint federal/state program: for every dollar spent by the federal government on Medicaid in Massachusetts, the state spends another dollar. And over the long run, as Medicare costs soar, the federal government will have less and less to spend on other programs that affect everyone, including Massachusetts residents.

The leading engine behind this unsustainable growth in spending is technology (See James Lubitz, “Health, Technology, and Medical Care Spending,” Health Affairs 2005; W5: R81-R85). While some forms of technology contribute much to health, others simply contribute to costs. Hospital beds, once built, will be used. But more is not always better. In a major study, Medicare enrollees living in high spending regions of the country received more care but did not have better health outcomes or greater satisfaction with their care (Elliott Fisher et al, “The Implications of Regional Variations in Medicare Spending: Health Outcomes and Satisfaction with Care,” Annals of Internal Medicine 2003; 138: 288-298).

The Public Health Council can do little more than rubber-stamp most of the requests it receives for substantial capital expansion. Massachusetts Determination of Need law does not permit the Public Health Council to do much other than review whether health care facilities submitting requests for substantial capital expenditures have engaged in the recommended planning process, whether they have developed the requisite community health services initiatives, and whether the proposed construction complies with existing standards. Ostensibly, the law is intended to “promote availability and accessibility of cost effective quality health care.” But the current statute promotes the evaluation of cost effectiveness without the ability to consider effectiveness. If Massachusetts is to have sound health policies, and if the PHC is to devote its time to the critical issues facing the state, the legislature will have to revamp the Determination of Need law of the Commonwealth.

Going for Broke

It’s official: combined federal spending on Medicare and Medicaid has reached 4.6% of the Gross Domestic Product (GDP), up from 4.2% in 2005, and on track to reach 5.9% in 2017 and a whopping 20% in 2050. These sobering estimates come from the Congressional Budget Office, not from a fringe radical group or an ultra-conservative think tank (see Peter Orszag and Philip Elis, “The Challenge of Rising Health Care Costs—A View from the Congressional Budget Office,” New England Journal of Medicine 2007; 357: 1793-5). At this rate, just about half of every tax dollar will go to fund these two programs by mid-century. This rate of expenditure is simply unsustainable—it would drive out support for education, roads, and parks, not to mention national security. Expenditures on Medicare will have to be cut and cut substantially. The biggest challenge for the future health of the baby boomers is how to restructure Medicare to provide good care at an affordable price.

The trick will be to put the brakes on technology, because it is the development and diffusion of new medical technology that has repeatedly been shown to be the engine fueling the growth in costs (for example, see L. Lubitz, “Health, Technology, and Medical Care Spending,” Health Affairs 2005; W5: R81-R85). To control technology without stifling progress, we will need to figure out to a far greater extent than we do today just how much benefit an innovation provides and to whom. Right now physicians and patients embrace technology—and Medicare pays for it—if the intervention has been shown to be beneficial, regardless of how small the benefit relative to either its cost or to alternative treatments. The effect of this strategy is that some regions of the country spend three times as much per Medicare enrollee as other areas with no discernible benefit in any health outcome (see the Dartmouth Atlas of Health Care, www.dartmouthatlas.org).

We will also have to recognize that older people are not a homogeneous population, and technology that is beneficial for one person may not help—or may even hurt—another. Accepting that different people benefit from different approaches to care, not just because they have different values and preferences but because of their underlying health status, will require a shift in our thinking. What we will need to do is to design different “pathways of care” for older individuals depending on whether they are robust, frail, or dying. The robust should receive something like today’s Medicare program; the frail, whether suffering from physical or cognitive frailty, should get less high tech and more disease management and home care; and the dying should all have palliative care resembling today’s hospice program.

Designing new approaches to care that are tailored to meet the needs of particular patients will enable the baby boomers to have a good old age: they will be offered technology when it can make a substantial contribution to health and well-being but will not subjected to invasive and painful technology when it is of little or no benefit. This is precisely the strategy we need in order to save ourselves from financial ruin. It also happens to be a compassionate and appropriate way to provide medical care to the elderly.

The Truth About Hospitals

In a bold move intended to foster quality care, the Massachusetts Hospital Association has begun posting data on its web site about the risks patients face if they are hospitalized,. Specifically, it reports on falls, on falls which cause injury, on surgical infections, and on the care for several conditions, including pneumonia, heart failure, and a heart attack. The new site is called Patients First (www.patientsfirstma.org) and it is intended to “educate people so they can make better decisions,” accorded to the senior vice president of the Institute for Health Improvement, which helped develop the new approach. Will this strategy in fact help patients decide where to seek their care? Is it a good idea?

It’s hard to imagine a patient in the throes of a heart attack checking out the web site to see which hospital in his area performs best. Odds are that the ambulance will take him to the nearest facility, regardless of his preferences. Moreover, most patients choose a physician, not a hospital, and accept that they will be hospitalized at whatever facility their physician practices.

Even if an individual patient did consult the web site to learn more about the hospital where his doctor worked, he would be hard pressed to draw any useful conclusions from the data presented. Take falls as an example. If you look up the hospital where I care for patients, the Brigham and Women’s Hospital, (BWH) you will find two different graphs, one showing the number of falls per 1000 patient-days, the other showing the number of falls with injuries per 1000 patient-days. In each category, you will find a rate for the medical floors, one for the intensive care units, another for combined medical-surgical units, a rate for step-down units, and still another rate for exclusively surgical floors. And for each location, you will see the BWH rate over a 6-month period compared to the “peer group average.”

I wanted to know how likely my patients are to fall and get hurt if they are on a medical floor at the BWH. What I learned is that the hospital has 0.96 injurious falls/1000 patient-days compared to the peer group average of 0.76. Presumably this means that the BWH is worse than average. But how much worse? Are the rates significantly different? Are the patients at the BWH comparable to the patients cared for in the “peer group” hospitals? What is the peer group anyway?

To get the answers to all these questions, you need to go to the Appendix, a 67 page document (also available on line) that describes the methodology on which the numbers are based. Hospitals are grouped according to size, so the BWH is lumped with all hospitals in Massachusetts having over 500 beds. That means Boston Medical Center, Massachusetts General Hospital, the Beth Israel Deaconess Medical Center, and the University of Massachusetts Medical Center. You can also find the confidence intervals for the rates reported, the statistical measure you need in order to figure out whether a given facility’s rate is significantly different from the rates at the other facilities. What you learn is that in fact, there is no significant difference between the BWH rate and the peer group average. In fact, if you look up the data for each of the hospitals with more than 500 beds, you will find that they all have equivalent rates, except Boston Medical Center, which does a bit less well.

What is also buried in the appendix is that that the fall rate of 0.96/1000 patient-days on the medical units at the BWH is based on a grand total of 2 falls that occurred in 2084 patient days. I wouldn’t want to draw any inferences based on 2 cases.

You might conclude that I don’t think much of this idea of publicly displaying data relating to quality of care. Actually, I think it’s an excellent idea, but not because it will help patients make choices. It’s a good idea because hospitals compete with each other and knowing how your neighbor is doing will stimulate you to do better. Above all, it’s a good idea because it helps hold hospitals accountable for the care they give and it encourages each facility to compete with itself to do better.

Of all the hospitals whose performance data is reported, I noticed only one that posted a comment about its own statistics. The Beth Israel Deaconess Hospital in Boston went beyond the numbers to say that starting in May, 2007 they developed and implemented an enhanced program for identifying patients at risk of falling. Their study teams discovered that the middle of the night is a particularly risky time. They responded to this observation by instituting a program of frequent checks at night. They also found that patients often fall when left unattended in the bathroom and have made efforts to ensure that high risk patients are not unsupervised in the bathroom.

This is exactly how hospitals should be responding to data. The BIDMC, it turns out, is way ahead of the curve. Spearheaded by its president, Paul Levy, the hospital has its own web site for reporting data. Called “Putting Ourselves Under a Microscope,” this site reports data on many of the same indicators as the Massachusetts Hospital Association. (www.bidmc.harvard.edu/thefacts)

The BIDMC compares its performance to a national average and to its own previous performance. And it sets targets for improvement, with a plan for how to achieve the targets. Now that’s impressive.

Don't Fall for It

In an earlier posting, “Break a Leg,” I recommended that frail older people use hip protectors to prevent hip fractures. The data, at that time, were suggestive but not conclusive. A recent study, unfortunately, definitively argues against the benefits of hip pads. In an article published in the Journal of the American Medical Association, Dr. Douglas Kiel and his colleagues reported on a large randomized trial that used a very elegant approach to answer a difficult and important question (D Kiel, J Magaziner, S Zimmerman et al, “Efficacy of a Hip Protector to Prevent Hip Fracture in Nursing Home Residents,” Journal of the American Medical Association 2007; 298: 413-422).

Earlier studies were plagued by all sorts of problems: people didn’t like wearing the hip pads, leading to what was called “poor compliance,” making it hard to analyze the results. The hip pads studied were made of differing materials and some of the pads may actually have increased the chance that a fall would cause an injury to the hip bone itself rather than merely to the surrounding soft tissue. This new study used a hip protector that had been shown to have the desired biomechanical properties. It was conducted in nursing homes, where the frailest elders live, the people with the highest risk of falling and fracturing a hip. And the investigators did something very ingenious: they used each nursing home resident as his own control. Every individual in the study wore a one-sided hip pad on either the right or left hip. The researchers would then observe all the residents over time to see whether the protected hip was any less likely to be fractured than the unprotected hip.

The study was carried out in 1042 individuals with a mean age of 85 who lived in one of 37 nursing homes located in Massachusetts, Missouri, or Maryland. What the authors found was that the nursing home residents were just as likely to fracture the protected hip as the unprotected one. In fact, the study was stopped early because preliminary evidence was so overwhelming that the hip pads, contrary to everyone’s hopes and expectations, simply did not work. Even when the analysis was restricted to the 334 nursing home residents who wore the pad more than 80% of the time, there was still no difference in fracture rates between the protected and the unprotected hip.

It would have been great to be able to say, at last, that hip pads really work. But at least we now have the necessary information with which to conclude that they don’t. Now we know that we shouldn’t spend money on hip pads. I have to retract my earlier recommendation. It’s time to look for other strategies.

A New Test for Alzheimer's Disease: Hype or Hope?

The New York Times reported today on “a blood test” for Alzheimer’s disease (Andrew Pollack, “Progress Cited in Alzheimer’s Diagnosis,” NYT October 15, 2007). Is there actually such a test? If not, is one imminent?

Don’t hold your breath. I’m old enough to remember the eye drop test for Alzheimer’s and the skin biopsy for Alzheimer’s, neither of which panned out, not to mention the serum beta amyloid test and a few spinal fluid tests. What the news media are reporting appeared in the on-line edition of Nature Medicine yesterday in a letter-to-the-editor, not in a peer-reviewed article (Sandip Ray, Markus Britschgi, Charles Herbert et al, “Classification and Prediction of Clinical Alzheimer’s Diagnosis Based on Plasma Signaling Proteins,” Nature Medicine online, October 14, 2007). This means the findings have not been written up in an article and subjected to careful scrutiny by other scientists who are experts in the field. The letter, penned by 25 scientists, notes that the group has been studying over 100 different proteins found in the blood of patients with a diagnosis of Alzheimer’s disease to see if some combination of them might serve as a diagnostic test. They have found that a particular pattern involving 18 different proteins successfully classified 8 out of 9 patients with Alzheimer’s disease (confirmed at autopsy) as having the condition. The results, while interesting, are far too preliminary to be of interest to the general public.

If we did have a test that could accurately diagnose Alzheimer’s disease, would it matter to the millions of people with cognitive impairment and their families? Probably not. Right now, physicians can already diagnose Alzheimer’s disease with 90% accuracy, based on a careful history and physical examination together with existing laboratory tests. Even more crucial, while it is useful to diagnose dementia (whatever the cause) so as to begin planning for the future, it’s only important to distinguish Alzheimer’s disease from other forms of dementia to the extent that we have good treatments specific to Alzheimer’s. Today, the only “treatment” we have for early Alzheimer’s disease is a group of drugs known as cholinesterase inhibitors—drugs such as Donepezil (Aricept). This medicine can temporarily improve cognitive function a very modest amount. Its effectiveness is so questionable that the British NICE (National Institute for Health and Clinical Excellence) recommends against its use in patients with mild dementia (see my earlier blog posting, “Americans, Alzheimer’s, and Aricept,” February, 2006). It doesn’t cause any harm if it’s administered to patients who prove to have a non-Alzheimer’s dementia, such as vascular dementia.

One day, when we have good treatments for early Alzheimer’s disease, it will be important to make the diagnosis early and accurately. Today, what a good doctor can do is good enough.