Quack, Quack--if it Sounds Like a Duck....

When Lydia Pinkham (1819-1883) began selling her patent medicine in the mid-nineteenth century, she advertised it as a panacea for all sorts of “female complaints.” Whether you suffered from “neurasthenia,” from menstrual cramps, from infertility, or from postmenopausal depression, Lydia Pinkham’s Vegetable Compound was the drug for you. It made Mrs. Pinkham and her descendants a bundle: as described by James Harvey Young in his book, Toadstool Millionaires, the remedy grossed $300,000 in the year of her death and in 1925, it earned a profit of $3.8 million. I’m not sure what that is in 2017 dollars, but it’s a lot.

Other patent medicines made similarly broad claims of effectiveness and were likewise lucrative for their developers. Warner’s "Safe Cure" stated on the label that it treated “Bright’s disease (nephritis), urinary disorders, female complaints, general debility, malaria,” and “all disorders caused by disordered kidneys and liver.”

These potions remained unregulated until the passage of the Pure Food and Drug Act in 1906, at which point the labels were required to be “truthful” about their ingredients. In particular, 11 dangerous substances including morphine, cocaine, and alcohol, which were frequently found in patent medicines (even in cough syrup for children) needed to be explicitly listed. There would be no evidence of efficacy required for another 32 years.

In the intervening years, both physicians and the public gradually began to appreciate that any drug that was touted as the treatment or even the cure for as many as ten distinct diseases was almost invariably a fraud and the disseminator of claims of its miraculous properties a quack. No one drug can plausibly have so many unrelated beneficial properties. Today, we are afflicted with the inverse of the one-drug-many-cures scam. We are bombarded with claims that a single disease can have many unconnected causes. And the disease for which such assertions are most commonly made is Alzheimer’s disease.

A few years ago, the media was all riled up by an article purporting to show that the anti-anxiety drugs, benzodiazepines,  were associated with an increased risk of Alzheimer’s disease. A year later, we learned that anti-allergy medicines and some antidepressants had also been associated with developing Alzheimer’s. Last year, the culprit was the class of anti-ulcer medications, proton pump inhibitors (drugs such as omeprazole). And now, instead of a medication, we have soda and other sugar-laden beverages allegedly leading to stroke and dementia.

Really? Do all these substances launch innocent people on the path towards dementia?

To be fair, there are disorders with multiple well-established risk factors. Coronary artery disease, for example, is associated with elevated cholesterol, diabetes, high blood pressure, and smoking. But in this case, we understand something of how the disease develops and how each of these risk factors affects that pathway. High blood pressure damages the lining of the coronary arteries, and the resulting areas of inflammation tend to trap cholesterol, producing plaques, etc. 

There are also single substances that produce diffuse toxicity: cigarette smoking has been associated with lung cancer, bladder cancer, and cancers of the head and neck (three very different types of cancer), as well as with heart disease and stroke. But again, we understand the mechanism of action that is responsible for the disparate effects. 

In the case of dementia, the connection between benzodiazepines and dementia, allergy medicine and dementia, proton pump inhibitors and dementia, and now soda and dementia, is purely statistical. Nobody has made a plausible argument for how each of these agents might work to trigger Alzheimer’s—even though we now know quite a bit about how the disease develops. No one has made a good argument because they haven't found one.

Nor is there a persuasive statistical argument. The studies based on which all these factors have been implicated in causing dementia are retrospective, non-randomized studies. The authors try to control for various “confounding factors” that might be the real explanation for the association, but they might not know what the relevant factor is or they might not be able to figure out if it was present or not. For example, maybe people who were ultimately diagnosed with Alzheimer’s disease were more likely than others to have taken benzodiazepines a few years before their diagnosis because they were already exhibiting very early symptoms, and those symptoms created anxiety.

Much exciting research is underway on Alzheimer’s disease, research that may someday result in treatment, prevention, or even cure. But fishing expeditions to come up with a commonly used drug or other substance as an explanation of this complex disease are a distraction. We don’t need people abandoning their ulcer medication or their allergy treatment out of an ill-founded fear that they are bringing dementia upon themselves. Stirring up hysteria—and potentially depriving individuals of good drugs—is a really bad idea.

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Advantage, (Medicare) Advantage

I said last week that I was a statistics junkie. A related penchant is for reports, especially government reports.  And few reports pull together more interesting facts about health care in the older population today than MedPAC, the Medicare Payment Advisory Commission. The Commission just sent its mandatory report on payment to Congress last month—it sends such a document every March, this most recent one totaling 483 pages. The report begins by telling us that total spending on health care in the US in 2015 was a stunning $3.2 trillion, or 17.8 percent of GDP. Of that, Medicare accounted for $642.2 billion, representing a rate of growth that has actually fallen in recent years. But the chapter I want to focus on today is the one on Medicare Advantage plans, those capitated, private plans that constitute an alternative to traditional Medicare.

My question is simply: how well do Medicare Advantage plans work? Do they save money? And most importantly, are they good for patients? How do clinical outcomes compare between Medicare Advantage (MA) plans and standard, fee-for-service (FFS) Medicare? What other benefits, if any, accrue to patients from enrollment in such plans?

It turns out I’ve been interested in this question for a long time because such plans have the opportunity to coordinate care, to mandate some services that are essential for the geriatric population (eg geriatric assessment for high risk patients), and to cover other important benefits (eg hearing aids and glasses). In fact, exactly 30 years ago I published an article in the Annals of Internal Medicine called, The Impact of Health Maintenance Organizations on  Geriatric Care. At that time, there were only 87 plans nation-wide (compared to 3500 today). Some were doing all right—as long as the patients they enrolled were all healthy older people. Others weren’t doing so well and several folded altogether. The challenge and, I suggested, the opportunity, was to decrease the rate of hospitalization among enrollees (the main way to cut costs), which in turn would require geriatric assessment in the ambulatory setting and geriatric consultation in the inpatient setting. It would work, I cautioned, only if HMOs provided case management, podiatry, and home physical therapy. They didn’t do those things and they never took off.

After two overhauls—the early capitated plans authorized by the Tax Equity and Fiscal Responsibility ACT (TEFRA) in 1982 were reborn as “Medicare Plus Choice” thanks to the Balanced Budget Act (BBA) in 1997, and then christened “Medicare Advantage”  by the Medicare  Modernization Act of 2003—capitated plans are finally on the upswing. In 2016, 17.5 million Medicare beneficiaries (31 percent) enrolled in such a program. The appeal is to some degree simplicity: instead of having to purchase separate coverage for physician care (Part B Medicare) and for prescription drugs (Part D Medicare) on top of free hospital care (Part A Medicare) along with Medigap insurance to pay for most of what Parts A, B, and D do not cover, you could sign up for a Medicare Advantage Plan that does it all. In exchange for restricting which hospital(s) patients can be admitted to and which physicians they go to, MA plans also offer some of those extras I advocated years ago, such as case management, and basic vision and dental care. So how good are they?

MedPAC mainly pays attention to costs. But it does devote a few pages to quality. It relies on HEDIS measures (Healthcare Effectiveness Data and Information Set) that plans are required to report as well as the quality measures that go into the star rating system of health plans used by CMS. And what it finds, over and over, is that FFS Medicare plans and MA plans are indistinguishable, whether in terms of objective measures (percent of enrollees who get flu shots) or subjective measures (percent of enrollees who say they can get an appointment quickly or who rate the quality as high).

I’d like to see the breakdown for individuals who are frail or who have advanced illness. I’d like to learn what services such as case management or palliative care consultation MA plans use (always, often, or sometimes) for this population. And I’d like to know whether seriously ill patients are apt to dis-enroll from MA plans once they become ill, as used to be the case, presumably because they were concerned about the limitations on choice of physicians they encountered. But in the meantime, at least for the average older patient, it seems that MA plans are an attractive alternative to conventional Medicare.

Counting what Counts

A confession: I’m a data junkie. I don’t generally collect data (though I have carried out a few empirical studies) and I don’t analyze data statistically. But I am fascinated by descriptive data, which often provide  remarkable insights into how things were or how things are. 

When I was working on my latest book (Old and Sick in America will come out in October), and I wanted to know what nursing homes were like on the eve of the introduction of Medicare, I consulted the report, “Characteristics of Residents in Institutions for Aged or Chronically Ill: 1963,” put out by the US DHEW (as the Department of Health and Human Services was called then). I learned there were just over half a million people living in 16,370 nursing homes (just about the same number of nursing homes we have today) and that they stayed there, on average for 3 years. 

When I wanted to know what hospitals were like in the 1960s, I read “Trends in Hospital Utilization: US 1965-1986” and found that circulatory disease, which has been the number one reason for hospitalization from the 1980s to the present, was only number 6 in 1965. Over the period from 1970 to 1986, the number of catheterizations done each year in people aged 65 and older would soar from 8,000 (or 3.8/10,000 people) to 275,000 (or 85.8/10,000) and that CABG (coronary artery bypass surgery) would likewise jump from 0 to 125,000 (or 42.9/10,000). So periodically, I check whether the National Center for Health Statistics has released any “Data Briefs” about older people. This past February, the agency published “Emergency Department Visits for Injury and Illness Among Adults Aged 65 and Over, US 2012-2013.” It is a compelling reminder that the emergency department is a key source of health care for older people.

Focusing exclusively on illness (as opposed to accidents), the report finds that the elderly go to the emergency room often and the older they get, the more often they go. Each year, 29 percent of people aged 65-74 have at least one emergency visit, as do 42 percent of those aged 75-84, and 57 percent of those aged 85 and up. About a third of these older patients arrive in the emergency room by ambulance—highlighting the role of ambulances as another locus of health care for this population.

These numbers don’t tell us what actually happens to older people when they reach the ER, but other data give a few clues. In the ER, the elderly are very likely to have some kind of imaging procedure (63 percent do), with about half of those getting a plain X-ray and a quarter getting a CT scan. And fully 32 percent of those presenting to the emergency department with an illness are admitted to the hospital; 5 percent to a critical care unit. There’s much that is left out if we focus only on descriptive statistics: we don’t know whether these patients typically have a friend or family member with them; we don’t know if anyone asks about their home situation; we are in the dark about whether anyone addresses their goals of care or checks if they can walk or determines their mental status. But the numbers are a place to start.

What is abundantly clear is that with 15.5 million visits to the emergency department by older people every year, it’s high time we pay more attention to what actually goes on there. We have the opportunity to figure our whether the hospital is the right place to take care of whatever the problem is and, if not, how to shore up the home environment to make it a viable alternative. To answer these questions, we need to make certain that older patients routinely undergo a brief assessment of both their cognitive and physical functioning. We need to involve a family member if support will be needed at home. I would bet that if we did all this, we’d make far more headway in avoiding hospitalization and decreasing the rate of readmission than many of the elaborate transitional care programs operating today.

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Now Hear This!

This week I'm posting a podcast I did for GeriPal about my forthcoming book, "Old and Sick in America: the Journey through the Health Care System."

Double, Double, They're In Trouble

The headlines on Tuesday, March 14 focused on two items: the blizzard that was belting the Northeast and the CBO report which predicted that 24 million Americans would lose health insurance coverage over the next 10 years if Trump Care became law. Far less prominently featured was the Senate confirmation of Seema Verma as head of the Centers for Medicare and Medicaid Services (CMS). Approved by a 55-33 vote, Verma could potentially have a major effect on the shape of health care for older Americans. So what do we know about Ms Verma?

We know she’s a first generation American and that she has a BA from the University of Maryland and an MPH from Johns Hopkins. She was the president and founder of SVC (which presumably stands for Seema Verma Consulting rather than superior vena cava, though I can’t find any reference on the website to what the letters stand for), an Indianapolis-based company that says it provides “strategic health policy solutions.” Her main claim to fame is that she (or SCV, Inc) came up with a strategy that enabled the Indiana Medicaid program to charge residents for premiums. She is widely expected to promote a similar strategy at the federal level as head of CMS. Medicaid is generally thought of as a program for the poor; how would Medicaid reform affect older individuals?

As of 2011, there are 10 million people who receive both Medicare and Medicaid, of whom 61 percent, or 6.1 million, are 65 or older. The remainder are younger people with disabilities. Just who are these people? The short answer is that they are the sickest, most impaired, and most vulnerable members of society. Nearly 3 in 4 have at least 3 chronic conditions. Over 60 percent need help with basic self-care activities such as eating, bathing, or dressing. And nearly 60 percent have a cognitive or mental impairment such as dementia.

And what does Medicaid provide for these “dually eligible” patients? Medicaid pays for nursing home care. It pays for long term care in the community. And it makes Medicare more affordable by helping cover Medicare premiums. The biggest chunk goes to long term care, with Medicaid allocating 62 percent of the $147 billion it spent in 2011 to long term care.

The amount that Medicaid pays for these services is considerable. Medicare beneficiaries account for 15 percent of Medicaid enrollment but 36 percent of Medicaid spending. Many states devote a considerable amount of their Medicaid spending to dually eligible, and 6 states spend over 45 percent of their Medicaid budget on the dually eligible.

What all this means is that Seema Verma could introduce policies that have widespread repercussions for 10 million people, over 6 million of them seniors. Within hours after being sworn in, she and DHHS Secretary Tom Price sent a letter to state governors urging them to impose premiums for the poor, charge Medicaid recipients for use of emergency rooms, and require many of those on Medicaid to get jobs. 

Reforming Medicaid, Republican style, would take the form of block grants. This means that the federal government would dole out a fixed amount of money to the states and allow them to set their own eligibility criteria. But it also means that there would be a cap on what each state gets, regardless of growth in the vulnerable population or their needs. 

States then have a choice: they can raise the eligibility standards, they can cut back on benefits, or they can reduce payments to providers. For people living in nursing homes, the single largest group of older individuals receiving Medicaid, how would that translate into practice? Well, the state could decide that only people with deficiencies in 5 activities of daily living (rather than 3 or 4) will be admitted to nursing homes under their Medicaid benefit, keeping more people at home longer without providing the necessary support to make this safe. Or it could limit the number of months it will cover nursing home care, forcing the burden of care onto families that in many cases have already concluded they cannot bear that burden. Or it could cut back the already bare bones payments to nursing home facilities, jeopardizing the quality of care in those institutions.

Medicaid matters. Write to Ms. Verma. Let her know.

What We Pay

The Princeton health economist, Uwe Reinhardt, first said it in 2004. The private think tank, the McKinsey Global Institute, persuasively demonstrated it was true in 2008. But maybe now that the Wall Street Journal is saying the same thing, policy makers will listen. The elephant in the room, the main factor accounting for the high cost of health care in the US, is prices.

The spending gap between the US and other developed countries remains huge. We spend 17 percent of GDP on health care (that’s all spending, public and private combined); our closest competitor, Switzerland, manages to spend 11 percent. Other OECD countries, such as New Zealand and Norway, spend closer to 9 percent. And despite all the excess spending, we don’t have better outcomes across a broad range of measures, from infant mortality to life-expectancy.

The main culprit, the WSJ reports, is higher prices in the US. The average price of most prescription drugs is higher here—by a lot. Avastin (an expensive medication but not the most expensive medication there is) costs $4000 for a 400 mg vial in America and less than $2000 in western Europe. Ditto for procedures: the cost of coronary artery bypass surgery in the US is $80,000, compared to half that in other OECD countries. And so on, down the line.  Elsewhere in the world, the WSJ explains, state run health systems set limits on prices or refuse to pay a supplier if the cost is regarded as excessive. Our free market system, far from keeping costs down, drives them up.

The McKinsey Report, though a few years old now, makes further adjustments based on a country’s wealth. It argues that richer countries may want to spend a larger proportion of their income on health care. But even adjusting for greater GDP per capita, the US spent $650 billion more than “expected” in 2006. The fastest growing part of the excess, the study showed, was due to outpatient care, both office visits and ambulatory surgery. And what was driving up costs in these domains wasn’t the frequency of visits—Europeans tend to go to the doctor at least as often as their American counterparts—it was the cost per visit. Other major contributors to the high cost of American health care are drug pricing (McKinsey found, as did the WSJ, that we pay more in the US for a given drug than we would in other OECD countries) and the cost of health administration (all the spending on marketing and administration of multiple private health plans boosts costs way over what they would be with a single payer).

I think it’s fair to conclude that the high cost of American medicine isn’t solely—or even mainly—due to waste. Targeting the use of less-than-optimal therapies in outpatient practice, as the Choosing Wisely campaign does won’t solve the cost problem. Nor will targeting expensive, burdensome, and unwanted treatment near the end of life. These are important efforts to improve quality of care. But if we want to do something about cost, we need to have an impact on prices. That means cutting payments made by insurers (both Medicare and private insurance companies) to pricey specialists. It means allowing the biggest and most influential insurer of all, Medicare, to negotiate with drug companies about price. It means allowing insurers such as Medicare to pay for devices based on their cost-effectiveness, not based on what the manufacturer charges. 

Introducing single payer health insurance would help, too. It happens to be the only other way to cover all Americans and make health insurance affordable and get rid of pre-existing conditions riders without use of the “mandate” that Republicans find so very unpalatable. But that’s a topic for another day.

You Don't Get What You Pay For

The enormous interest in getting good “value” for every dollar spent on health care, whether by individuals, insurers, government, or anyone else neglects certain basic realities—for example, that medical care isn’t a consumer good like toasters: it’s a very sophisticated service provided by highly trained professionals;  and that health insurance by its very nature makes the operation of a free market impossible. There’s still another basic reality that is even more often neglected, and that is the widespread belief that “you get what you pay for.” Or, if you pay less for one treatment than another, the cheaper one is necessarily inferior. Any claims that the two are of equal quality are suspect. And claims that the cheaper one is higher quality are, on their face, deemed outlandish.

Translated into practice, this means that patients and doctors alike tend to assume that more is better. More x-rays (or, as plain radiographs, CT scans, MRIs, and PET scans are collectively known, “imaging studies”), more medications, more doctors is superior care and must result in better outcomes. As a result, I’m not at all surprised that changing physician behavior and patient expectations has proved difficult, even when professional guidelines assert that less is more. And unfortunately (unfortunate since, from a geriatric perspective, less often is more), a new study that purports to show that greater spending per hospitalized patient fails to improve outcomes is hardly convincing.

Previous retrospective studies, especially those comprising the Dartmouth Atlas of Health Care, have shown that expenditures on apparently similar patients differ by geographic region, by hospital, and within regions—without any measurable difference in outcomes. But the Dartmouth Atlas has been criticized for working backwards from death even though death could not have been predicted in advance, it has been criticized for failing to adequately consider differences between the patient population in different locales, and it has been critiqued for not acknowledging that patient preference might account for some of the observed differences in health care utilization and, as a result, in cost. The new study asks whether physicians working in the same hospital nonetheless exhibit differences in their pattern of test- and treatment-ordering and whether that variation results in different outcomes for their patients. Looking at over 1.3 million hospitalizations occurring at over 3000 hospitals and involving 72,000 physicians, they found large variability in expenditures and no difference in outcomes—just like the Dartmouth Atlas findings.

The authors were careful to look at Medicare Part B spending because this is involves services that are at the discretion of physicians (Part A spending is determined largely by the DRG, the reason for admission, and is set by Medicare) and is a “proxy” for the intensity of resource use by physicians. They were careful to confine their analysis to Medicare fee-for-service beneficiaries who were age 65 or older and hospitalized for an acute medical condition. And they examined separately the behavior of general internists and hospitalists. They made some adjustments to account for differences among patients, including age (in 5-year increments), sex, race/ethnicity, median income, and existing comorbidities, and other adjustments to account for differences among physicians, including age (also in 5-year increments), sex, and site of medical school education. They found that the variation in spending across physicians within a hospital was greater than across hospitals. Among hospitalists, adjusted spending was more than 40 percent higher among doctors in the highest spending quartile compared with the lowest quartile. And higher expenditures had no effect on either the 30-day readmission rate or mortality, the two measures of quality used to examine outcomes.

Regrettably, this study has a number of glaring weaknesses. First, there are the odd omissions: the authors report on the gap between the highest and lowest quartiles of hospitalists but not the corresponding figure for general internists, even though nearly twice as many patients were cared for by internists than by hospitalists. Next, it’s not clear that the two outcomes examined—mortality and readmission rate—are good indicators of quality. Or rather, even if the two groups were indistinguishable based on these two measures, perhaps one group fared far better than the other on some other measure that wasn’t looked at, say quality of life. Finally, the study wasn’t randomized and it wasn’t prospective, allowing for the possibility that there were important differences between the patients on whom much money was spent and those on whom less was spent. In fact, maybe the patients on whom more resources were expended were sicker. If they were sicker but had the same mortality rate and readmission rate as those on whom fewer resources were spent, then arguably they fared better than their counterparts!

So where do we go from here? Contrary to the prevailing wisdom, the answer may not lie with “big data.” Too many things are going on at once with these patients to be able to reliably conclude that ceteris paribus, all things being equal, overall expenditure on tests and treatments had no bearing on outcomes. I think it would make sense to look at a small number of detailed case examples—20 or 30 patients of the same age with the same admitting diagnosis, matched for severity of illness, co-morbidities, race, ethnicity, and socioeconomic class, some of whom are cared for by prolific test-orderers and some of whom are not—following them prospectively over time to see what happens to them. And the study would try to ascertain why various choices were made, perhaps by interviewing the patients and/or their doctors, perhaps by gleaning the answer from free text in medical records, and what their outcomes turned out to be.