September 16, 2014

On September 17, the Institute of Medicine will release its report, "Approaching Death: Addressing End of Life Issues," which will be the subject of my next post.

September 14, 2014

The Methuselah Prize

A startling new project was unveiled last Tuesday in the San Francisco Bay area. No, not Apple’s iPhone 6 or its watch, but the Palo Alto Longevity PrizeNever heard of it? Well, you still have a few more months to sign up to enter the competition to win $1 million for unlocking the secret to immortality. Is this just hype or is there some hope here for an important scientific breakthrough?

The basic idea is this: what we are doing now, attacking the maladies of old age one at a time, is simply trading off one bad disease for another. We’re already succeeding: the death rate from cardiovascular disease has fallen over the past several decades—and the death rate from Alzheimer’s disease has risen. As long as human life expectancy remains stable, we’re talking about a zero sum game in which you fix one problem and substitute another. So far, it looks as though dementia will be the big winner, which makes research aimed at turning off the switch that triggers all the diseases of old age very appealing. The underlying assumption of longevity research is that the degenerative diseases such as cancer, heart failure, and dementia are the result of the aging process. Preventing all the conditions that both limit life’s duration and impair its quality seems far more attractive than the disease-specific approach. But is it feasible and is it ethical?

The majority of credible scientists believe that life-extension is a very hard problem whose solution is not around the corner. The Palo Alto Longevity Prize, to the credit of its mastermind at Palo Alto Investors, Yoon Jun, is focused on somewhat more modest and potentially achievable goals. Part one of the prize is $500,000, to be awarded in June, 2016. It will go to a team that can restore the adaptive capacity of a laboratory animal; specifically, an aging animal will need to regain the heart rate variability characteristic of its youth. Part two of the prize is another $500,000 award, to be granted a year later to a team that increases an animal’s longevity by 50%. In both cases, the scientists will have to achieve their goal by enabling the animal to preserve homeostasis—the ability to maintain the status quo (temperature, blood pressure, etc) in the face of a stimulus, a capacity that is gradually lost with aging. Is this a worthwhile goal?

Impaired capacity for homeostasis is at the heart of frailty. The reason people lose their balance and fall easily, or get pneumonia when they contract the flu, or become confused when they are hospitalized is that they are vulnerable to modest “stresses.” So the key to physical frailty, and quite possibly to cognitive frailty (dementia) as well, is maintaining homeostasis. The Longevity Prize seeks to figure out how to do just that, but it is not without risks. As the Struldbrugs of Gulliver’s Travels showed, immortality without eternal youth is tantamount to hell-on-earth: failing vision, declining hearing, impaired cognition with no escape through death. Suppose unlocking the key to immortality does indeed prevent cancer and heart disease—but not arthritis and visual loss? The idea is to prevent all the degenerative conditions of old age, but suppose there isn’t just one switch, but several?

Even if we had confidence that achieving a longer life would not create a race of Struldbrugs, is it a good idea to devote scarce resources to trying to find the key to immortality? As NIH funding shrinks and the need to prioritize research questions grows, surely there are more urgent medical questions than how to live longer. Most people would opt to prevent premature death (infant mortality, teen suicide, cancer deaths in middle age) before they seek life-extension past the biblical allotment of three score and ten. Most physicians who witness the numerous ways patients suffer throughout life’s trajectory would recommend focusing on quality of life before quantity. And many people worry that if researchers did come up with an elixir of life, it would be so expensive that only a very small number of people could afford it, creating a new elite of Immortals.  So perhaps government should not fund longevity research, but what about the private sector? Google invested in Calico, a biotech startup devoted to finding ways to reverse aging. Earlier this month, Calico opened a new research facility in San Francisco where many talented scientists will search for the elusive spigot that can turn off the aging process. People in a free society choose to do all kinds of surprising things: they go bungee jumping, they sign up to travel to Mars, they smoke cigarettes. If Google wants to invest some of its advertising revenue on preventing the degenerative conditions associated with aging, why not?

If it’s reasonable to work on longevity, is offering a prize the right way to go? This approach got quite a bit of media attention a few years ago when Netflix promised $1 million to an individual or team that could improve its predictions of the movie ratings of individual viewers by 10%. This challenge stimulated a great many computer science graduate students and faculty members to spend hours trying to solve the problem. I know because my oldest son was one of them and he wrote about the math underlying the Netflix challenge for the on-line science journal, Science 2.0 when, after 3 years, a winner was announced. It turned out to be a good strategy for Netflix: for a relatively modest investment, the company recruited many fine minds to work on what would prove to be a difficult problem, without having to pay benefits or to pin their hopes for a solution entirely on one individual. Other organizations have issued similar challenges: the Millennium Prize, for example, announced by the Clay Mathematics Institute in 2000, offers $1 million for the solution to each of 7 great unsolved mathematics problems. As of today, only one of the 7 has been solved (and the individual to whom it was awarded, the reclusive and quirky Russian mathematician Grigori Perelman, declined the prize).

Perhaps the earliest use of a financial incentive to solve a scientific problem was the “Longitude Prize,” offered by the British Parliament in 1714 for an answer to how sailors could correctly establish their position at sea. Sailors had long used the stars to determine their latitude, but until the clockmaker John Hunter got his 20,000 pounds (worth about $5 million today) for solving the longitude challenge in 1765, they had been unable to determine their longitude. In recognition of the success of the first Longitude Prize—it was probably the last great breakthrough in navigation before Global Positioning Systems—a public private partnership in England recently launched the Longitude Prize 2014This competition took an old approach and added a new wrinkle. A panel of experts came up with a list of 6 scientific problems in desperate need of a solution, and then asked the British public to vote on which one to sponsor. The election was held in June and the winner was the problem of antibiotic resistance: designing an easy to use, cost-effective way to test for antibiotic sensitivity at the point of care (which in turn would prevent doctors from giving a drug to which the relevant germ would not respond, an all too common scenario that both fails to cure the patient and also promotes further antibiotic resistance). The winner will receive 10 million pounds (about $16 million). Whether the competition will achieve its objective remains to be seen.  In many such competitions, including the Millennium Prize discussed above, nobody ever wins.

In sum, I doubt very much that the Longevity Prize will result in immortality and I’m glad that it’s a hedge fund and not the NIH that is sponsoring the competition. That said, it’s entirely possible that there will be valuable spinoffs from the kind of research that the prize is fostering, much as 19th century anti-aging experiments using animal gland extracts led to hormone replacement therapy and tissue transplantation was stimulated by early 20th century experiments in rejuvenation through grafting. 







September 10, 2014

September 07, 2014

Is Medicare on the Mend?

A buoyantly optimistic Paul Krugman proclaimed recently that Medicare’s woes are over—after a long period of seemingly relentlessly rising costs, costs that were rising so fast that they were clearly the major threat to the federal budget, Medicare per beneficiary expenditures actually fell last year. Economics guru and NY Times editorialist Krugman argues that the good news cannot simply be attributed to the recession because Medicare is a government program and therefore recession-proof. Now it’s dangerous to take issue with a force such as Krugman.  But I want to at least raise the possibility that Medicare expenditures are not immune to the economic downturn because of the large amount of money that Medicare beneficiaries pay out of pocket for health care. And if a patient doesn’t get a drug prescription filled, for example, because his co-pay is too high, then Medicare does not have to pay for that drug, and expenditures fall. In this vein, a report released in July by the Henry J. Kaiser Family Foundation, “How much is enough? Out-of-pocket spending among Medicare beneficiaries: a chartbook” is very sobering.

The main findings of the report (see chart in previous post) are that fee-for-service Medicare recipients spent an average of $4734 out of pocket for health care in 2010, up from $3253 in 2000--a 44% increase. Most of that spending is by those age 85 or older: they spent an average of $5962 out of pocket compared to only $1926 for those ages 65-74.  And older people with 3 or more “ADL deficits,” or difficulties carrying out basic daily activities, spent a mind-boggling $9200 on health care, mainly on services. Out of pocket spending went to items such as Medicare premiums, other supplementary insurance, and long term care. In addition, 11% went to paying for prescription drugs as Medicare Part D has evolved since its inception to include more and more cost shifting to patients.

Interestingly, my colleagues at the Harvard Pilgrim Health Care Institute, just published a study in Health Affairs in which they present data indicating that older patients are increasingly skipping pills, taking less than the prescribed doses of medicines, or failing to fill prescriptions altogether in order to save money: among patients with 4 or more chronic conditions, they found that while 14.9% experienced “cost-related medication nonadherence” in 2005, this rate fell steadily until it reached 10.2% in 2009, and then it began rising again, reaching 10.8% in 2011.

So it is entirely possible that the fall in Medicare costs reflects at least in part decisions made by patients to forgo particular pricey interventions. The result, predictably, would be savings to the entire Medicare program. Now whether such choices made by patients adversely affects their health is another matter.  The Health Affairs study assumes that non-adherence to medications is likely to lead to adverse health outcomes including worth health states and increased rates of hospitalization, especially in older individuals with multiple chronic conditions. They base their assumption on studies from the 1990s, principally conducted in the mentally ill and in Medicaid patients, that in fact showed that when patients did not take their medicines as prescribed, their clinical condition deteriorated. Whether the same would hold true for chronically ill older patients today is not so clear: there is ample evidence that older individuals with multimorbidity are at increased risk of adverse drug reactions the more medicines they take and that following the guidelines for all the diseases they have can cause falling, fainting, confusion, and other problems. Nonetheless, it would be preferable for physicians to make wiser prescribing decisions based on an understanding of physiology rather than leaving it to patients to decide which medications to forgo based on cost.

Medicare expenditures are falling and it behooves us to understand exactly why and to evaluate the consequences. Whether the cost saving strategies of the Affordable Care Act are responsible, and whether the particular decreases in costs have had any effect on patients’ health and well-being, is yet to be determined.

September 02, 2014

Out of Pocket Health Care Costs for the Frail are Over $9000

Here's an interesting graph from the Henry J. Kaiser Foundation's recent report on out of pocket health care spending by Medicare beneficiaries. More to follow on this topic in my next post.

September 01, 2014

Penny Wise, Pound Foolish

What drove me crazy about practicing medicine in a nursing home wasn’t the patients, although with their many medical problems often including cognitive impairment they were a challenge; and it wasn’t the families, though with their anxiety and attentiveness and sometimes their guilt they were an even greater challenge. What drove me crazy about nursing home medicine was Medicare billing.

When I saw patients in the nursing home, I was hemmed in by the fact that Medicare had a very clear idea of what constituted an appointment with a nursing home patient. According to Medicare, a “visit” (billing jargon) entailed a face to face “encounter” (more billing jargon) between a “clinician” (in this case, me, the physician) and the patient.

Once the patient and I were in the same room, I had a script to follow. I was first supposed to take a “history,” (medicalese for eliciting symptoms); then I was supposed to do a physical exam, which involved specified “elements” (examination of particular bodily parts). Finally, I was supposed to engage in “evaluation and management,” which might result in ordering lab tests or prescribing a medication. The problem was that in the nursing home environment, a history and physical, to be useful, looked very different from what Medicare had in mind. Many of my patients were demented and couldn’t possibly give a coherent history. Moreover, many of those who had relatively mild dementia could always be counted on to complain about something, so if it had been up to the patient, I would have made a visit every day. Many of the patients had medical conditions that required observation over a prolonged period, not just at one point in time. For example, a patient with dementia might have paranoid delusions that significantly affected his or her quality of life, but those delusions would come and go. A patient with Parkinson’s disease might have difficulty walking that fluctuated over the course of the day, depending both on random changes and on when the patient last took medication. As a result, the most meaningful history and the most useful physical observations had to be obtained secondhand—from nurses, nurses aides, and other staff members including physical therapists and social workers. I spent much of my time interviewing personnel about my patients, time that Medicare did not recognize as valuable because it was not part of an “encounter.”

Starting in January, 2015, Medicare will pay a special monthly “complex chronic management” fee on top of the usual reimbursement to primary care patients who care for patients in the office. But somehow the nursing home environment is assumed to be immune from the need for this kind of supplementary support. Calls to family members and discussions with other members of the interdisciplinary team are supposed to be part of the “evaluation and management” services that are “bundled” into the Medicare fee schedule. So it’s thought to be perfectly reasonable for a physician to be paid $92 in 2015 for a nursing home visit for an acute medical problem such as a new pneumonia (code 99309). To merit this payment, the physician must provide documentation that he or she has taken 2 out of 3 possible steps: obtained a detailed history, performed a detailed physical exam, or engaged in “moderately complex” medical decision making. Only if the physician takes a comprehensive history, performs a comprehensive exam, and engages in highly complex medical decision-making can he or she bill with the code“99310,” earning the somewhat more generous sum of $136. For comparison, note that a gastroenterologist is paid on average $220 for performing a colonoscopy, a 20-minute procedure. 

No wonder physicians often respond to a call from the nursing home about a sick patient with an order to send the patient to the hospital for evaluation. Send a frail nursing home patient to the emergency room and he has, I would guess, about a 90% chance of being admitted. So instead of paying a physician an appropriate amount for making a visit to the nursing home and instituting on-site medical care, Medicare would fork out a minimum of $5774 (the base DRG payment) for a 5-day hospitalization, exposing the patient to the risk of iatrogenesis. Does this make any sense?









August 18, 2014

Modernizing Medicare

The Medicare Modernization Act of 2004 didn’t really modernize Medicare. It took the important step of creating coverage for prescription drugs, which are the backbone of medical treatment of older individuals. But apart from this one change, albeit a major one, Medicare was pretty much intact. The problem with the approach to healthcare enshrined in Medicare, a program that turns 40 this year, is that it assumed that most illness is acute illness that requires hospitalization. In fact, it including coverage for anything other than hospital care in Medicare was more or less an afterthought. But today, most illness is chronic illness and the sickest, costliest patients typically have multiple chronic conditions.

The good news, as summarized in a perspective in JAMA this week entitled “Optimizing health for persons with multiple chronic conditions,” is that Medicare has made a number of changes that move the program into the modern world. The article indicates that the government report, “Strategic Framework on Multiple Conditions,” released in 2010, articulated 4 goals: fostering health systems change, empowering individuals, equipping clinicians, and enhancing research. Funds from the Recovery and Reinvestment Act and the Affordable Care Act have gone a long way to supporting initiatives in each of these domains. For example, in the realm of health systems change, the Centers for Medicare and Medicaid Services (CMS) is financing integrated models of primary care; to empower individuals, government funds have supported widespread participation in Stanford’s Chronic Disease Self-Management Program; to help clinicians, many professional societies have issued guidelines that are modified for patients with multimorbidity; and to enhance research, the Patient Centered Outcomes Research Institute (PCORI) was created and is a primary source of research funding. But there’s a problem.

The problem is that the patients we really need to worry about—because they get poor quality care, they cost a great deal, and despite all the money we spend on their medical care, they don’t even get treatment that is consistent with their preferences—aren’t patients with 2 or more chronic diseases. As the authors of the JAMA article comment, we need to focus on patients who are at greatest risk of poor outcomes and high costs. The patients we need to pay most attention to are those who are old and frail. And while many people who are old and frail also have multiple chronic diseases, not all of them do; moreover, having multimorbidity is not sufficient to qualify as frail.

The trouble with frailty is that we don’t have a good way of measuring it. And the measures we do have, which include such things as how strong a person is or how quickly he can walk, aren’t anything that doctors routinely test for, let alone record in the medical record. Insisting that all doctors use electronic medical records won’t allow us to keep track of who’s frail if we don’t enter frailty (or the various measures that define it) into that record. There is now a way that primary care doctors can screen for frailty by asking patients 5 questions, and their answers, while subjective, seem to correlate quite well with more sophisticated tests for frailty. But right now, doctors don’t ask those questions (they include things such as “are you able to walk up a flight of stairs” and “are you exhausted all the time”). Unless we can determine who is frail, we are not going to be able to test the effectiveness of special programs intended to provide medical care for them.

I think a solution may be on the horizon—and it’s not shipping special calipers to measure grip strength to every primary care doctor in the country. The answer, I suspect, is to use a proxy measure for frailty. That surrogate measure is multimorbidity plus functional impairment. It turns out that the people who are hospitalized most often, who take the most medications, and who go to physicians most frequently are people who have at least two chronic diseases and who have trouble with one of their activities of daily living.  

We can refine this group even further by focusing on those who get help with a basic daily activity: 14% of the population or 42 million people have at least one chronic disease and a functional limitation, but only 14 million of them need assistance to get by, and of those, 8 million are 65 or older. And those who have 5 chronic diseases and get help (regardless of age) have average per capita health expenditures of $22,380 compared to $12,749 for those with 5 or more chronic diseases and functional limitation but no help and to $9,723 for those with 5 or more chronic conditions but no functional limitations. 

It’s time to track patients who are over 65 by the number of chronic conditions they have, whether they have functional limitations, and whether their functional limitations are sufficiently severe to require assistance. Only then will we able to determine if these measures define who is at highest risk for adverse reactions to hospitalization, for progressive disability, and for death, and who costs the health care system the most money. Only then will Medicare be able to pay for the right kind of care for all older people. Once we do that, we will have truly modernized Medicare.

August 15, 2014

Acronyms of Doom

When I was in medical school, U.S. hospitals were plagued by only one kind of “superbug” or antibiotic resistant bacteria. Methicillin-Resistant Staphylococcus Aureus, abbreviated as MRSA and pronounced “mursa,” was the Enemy and it had been around since the early 1960s. I remember the yellow precaution signs on the door of rooms housing patients infected with this organism and the ritual donning of a yellow gown and surgical gloves before entering those rooms. Staph colonizes the skin of healthy people; if it enters the body through a break in the skin it can cause a serious infection, and if the staph is resistant to what was previously the best drug for treating it, the patient can be in trouble.

Then in the late 1980s, along came another bad actor, Vancomycin-Resistant Enterococci (VRE). Enterococci normally inhabit the gastrointestinal tract; sometimes they escape and when they do, for example through fecal contamination of a wound, they can cause significant mischief. Enterococcal infections had come under control with the antibiotic vancomycin—until they developed resistance. Now, MRSA and VRE have been joined by a new threat: Carbapenem-Resistant Enterobacteriaceae (CRE). According to a study published this month, the rate of detection of this infection has jumped five-fold in 5 years. And the mortality from these infections ranges from 48% to 71%. The Centers for Disease Control and Prevention (CDC) in Atlanta took the extreme measure of classifying CRE as an urgent threat. Only 2 other organisms currently share this honor.

The newest superbug, like MRSA and VRE before it, is something that healthy people don’t normally contract. Its victims are patients in nursing homes and hospitals, especially people who are connected to a medical device such as a ventilator or a catheter (whether urinary or intravenous). Debilitated older people are at particularly high risk. The CDC offers a 4-prong strategy for attacking the problem (preventing infection in the first place, tracking resistant organisms, improving the use of today’s antibiotics, and promoting the development of new antibiotics). I suggest an additional strategy that is rarely discussed: keeping frail, old people out of the hospital altogether.

From the time that the hazards of hospitalization were first recognized 50 years ago, the main way doctors have proposed dealing with them is to try to make hospitals safer. Old people become confused in the hospital? Don’t give them sedating medicines that make them confused. Old people fall in the hospital? Use bed alarms and chair alarms to alert nurses that they are getting up. These tactics and others can be helpful, but they don’t eliminate the dangers of the hospital and some interventions, such as side-rails on hospital beds, increase rather than decrease risk. Similarly, our first impulse as we try to control superbugs such as CRE is to reach for the precaution gowns to keep nurses and doctors from spreading the germs. Because antibiotic resistant bacteria are so great a problem, we need to respond with a multi-prong strategy. So yes, educating physicians to use antibiotics judiciously (preventing the development of resistance in the first place) and encouraging pharmaceutical companies to design new effective antibiotics are important. But let’s not forget that in most cases, the patient would not have gotten the infection if he or she hadn’t been in the hospital—these are generally hospital-acquired infections, not the reason for the hospitalization. Sometimes, frail old patients can be treated satisfactorily outside the hospital. Finding an alternative to hospital care is a way to avoid a growing list of “adverse reactions to hospitalization,” including delirium (acute confusion), incontinence, falls, and all those acronyms spelling doom, MRSA, VRE, and now CRE. 

August 11, 2014

Pursuing Palliation

We’ve known for a long time that breaking a hip can be devastating for an older person. It often leads to a loss of independence and it's associated with a substantial increase in the risk of both nursing home placement and death. While the rate of hip fractures declined in the US between 1990 and 2010, it remains stubbornly high: every year, 300,000 people fall and fracture a hip. A new study suggests the consequences of a hip fracture are especially severe in people who live in nursing homes.  In light of the high rate of disability and death in the 6 months after a hip fracture, an accompanying editorial recommends that breaking a hip in the nursing home signal the need for palliative care. Absolutely—but many of the patients reported in the new study should have been getting palliative care long before their fateful fall.

The authors of the study in JAMA Internal Medicine identified 725,000 Medicare fee-for-service patients who broke a hip during a 4-year period between 2005 and 2009; just over 60,000 of them, or 8%, lived in a nursing home prior to sustaining a hip fracture. It was these 60,000 who were the basis of the study:  the vast majority were women (75%), white (92%) and demented (91%). They also tended to have multiple chronic diseases and to have difficulty with many basic daily activities, which is hardly surprising, as their illnesses and their impairments were precisely why they lived in the nursing home.

After their hip fractures, many patients went downhill quickly. Fully 36% were dead within 6 months. Among those who survived to the 6 month mark, over a quarter had become totally dependent in walking. By the time a year had elapsed, just under half of the residents who had fractured their hip had died. Only 1 in 5 of those who started out being fairly independent in walking had regained their previous level of function. Risk factors for death or disability included male sex, advanced age, white race, multimorbidity, cognitive impairment, and dependence in basic activities. Of note, patients treated non-operatively (11.8% of the sample) did particularly poorly in terms of physical functioning and survival.

These findings fit with the results of earlier, smaller studies. But I couldn’t help asking, as I read this dismal portrait of life-after-hip-fracture-in-the-nursing-home, what happens to people who live in a nursing home who don’t break a hip? How many of them decline? The study in JAMA Internal Medicine had no control group, no nursing home residents with a comparable degree of physical and mental impairment, cared for during the same time period, who happened not to sustain a hip fracture.

I turned up another study also published this year entitled “Natural course of dependency in residents of long-term care facilities: prospective follow-up study.” The study was carried out in Dutch nursing homes and it included both people who had hip fractures along with those who did not. The population was reasonably similar to the US nursing home Medicare population: 75% were women and their mean age was 84. The Dutch have a system for reporting dependency that is different from (and more sophisticated than) the American approach: they report on the “Care Dependency Scale (CDS),” a 15-item scale that grades patients from 15 (totally dependent) to 75 (almost independent in eating, dressing, walking, and dressing). What they found was that among 890 Dutch nursing home residents, just under 15% had died at 6 months and another 18% had died by one year. But the degree of dependency at baseline was strongly predictive of the outcome, with higher dependency leading to greater likelihood of death, even after correcting for gender, age, and the presence of diagnoses such as cancer or dementia. Among residents in the low CDS group (that is, the most independent people), 20% actually improved over a 12-month period and the vast majority (80%) remained unchanged. Among residents in the highest CDS group (the most dependent people), no one improved, 64% remained stable over 6 months, and 36% got worse. The middle group, not surprisingly, fell between these extremes.

How did the nursing home residents in the Dutch study (some unknown fraction of whom fell and broke a hip) compare to the nursing home residents in the American study (who were selected based on their having fallen, broken a hip, and been hospitalized)? Those with hip fracture did worse: over the course of a year, 80% deteriorated markedly in their independence, compared to only 36% of the worst-off Dutch residents; and by 6 months, 36% had died, compared to about 20% of the worst-off Dutch.

These comparisons are approximate at best, but they give some hint of what the Medicare nursing home residents might have expected if they hadn’t broken a hip. So while a hip fracture does represent a turning point, admission to a nursing home in the first place also represents a turning point, a transition to life’s final chapter. Thus while it is eminently reasonable to offer palliative care alongside of surgery to all nursing home residents who break a hip, it would be even better to offer palliative care alongside conventional medical care to everyone in the nursing home.