June 28, 2018

MedPAC Speaks

I once called MedPAC the most influential organization in the medical arena that most Americans have never heard of. That was in a blog post from April, 2009 called “Follow the Money.” I continue to find MedPAC—the non-partisan, independent congressional agency that advises on issues related to the Medicare program—an excellent source of information and analysis. Its 17 members, representing academia, public health, medicine, and industry, make recommendations to Congress for revisions to the Medicare program twice a year. The March report is called “Medicare Payment Policy” and the June report is “Medicare and the Health Care Delivery System.” This month’s report contains more than the average share of interesting material. 
There’s a section specifically mandated by Congress that analyzes the Hospital Readmissions Reduction Program (it found, on average, that the program led to a 3.1 percent decrease in readmissions for five major medical problems, although it couldn’t be sure that the program caused the drop). Another section addresses how to improve Medicare’s approach to paying for medical devices (among other tactics, limit the ability of physician-owned distributors through greater regulation and accountability).  There’s a chapter on Accountable Care Organizations (possibly effective in controlling costs and improving quality, but with various modifications proposed). But what intrigued me most was the final chapter on “Medicare coverage policy and use of low-value care.”
MedPAC defines “low-value care” as services (including treatments, medications, and tests) that are of “little or no benefit” and where the risk of harms exceed the potential benefits. That, of course, is a value-laden definition since it assumes “benefit” can be clearly established and quantified, ditto for “harms,” and that we know the probability of either benefit or harm. Nonetheless, a remarkable number of treatments, medications, and tests are widely agreed to fall into this category. They comprise the list of no-no’s compiled by specialty professional societies for the Choosing Wisely campaign which, in its first five years of operation, came up with 525 recommendations. 
For frail elders, incidentally, the relevant professional organization inventoried by Choosing Wisely inveighed against gastrostomy tubes in people with dementia, obtaining urine cultures for people without urinary symptoms, use of lipid lowering agents in people with a limited life expectancy, screening for breast, colorectal, or prostate cancer in individuals with a life expectancy of less than ten years, hospitalization without taking into account goals of care, and aggressive blood pressure regimens.
The first observation MedPAC makes about low-value care is just how widespread it is among Medicare fee-for-service beneficiaries. Using two measures developed by Aaron Schwartz, Bruce Landon, and colleagues, the commission estimated that between 25 and 42 percent of patients over age 67 received at least one value service per year, costing Medicare between $1.9 and $8.5 billion. Imaging tests, cancer screens, and other diagnostic and preventive tests accounted for the lion’s share by volume, with cardiovascular tests and imaging the major offenders in terms of cost.
MedPAC concludes by considering six “tools” that could improve the situation. The commissioners raise the possibility of expanding the use of pre-authorization, a much-despised approach used by prescription drug plans and hospitals to limit the use of expensive medications. This tactic would create administrative obstacles to the use of various tests and procedures—and would further the bureaucratization of medicine deplored by many physicians. 
They also propose implementing “clinician decision support” programs and provider education, claiming that inappropriate antibiotic prescribing has been reduced in this way. No one could disapprove of trying to make clinicians wiser and more knowledgeable—the question is how to achieve this. Many of the usual “decision support” and “education” programs have been of dubious benefit. 
Another option is increased cost sharing. This is a favorite approach of commercial insurance programs but mercifully has rarely been used by Medicare—it places the burden for deciding whether a test is worthwhile squarely on the shoulders of patients, often without providing them with the information necessary to decide. It encourages wealthy people to squander their resources on low-value tests since the cost-sharing involved is trivial for them, and it may distort the decision-making of the less affluent by leading to their accepting cheap but useless tests and rejecting expensive but useful ones. 
Then there’s the strategy of revisiting Medicare’s “national coverage decisions” periodically—for the small number of tests in which the choice about coverage is made at the national level. The problems with this approach are that it fails to address the vast majority of coverage decisions that are made at the local level and that the reality is that revisiting coverage decisions has historically led to Medicare’s paying for more procedures, not fewer.
That leaves only two options to MedPAC. The first is introducing new payment models in which providers are held accountable for both cost and quality. This is the rationale behind Accountable Care Organizations and it may be working, according to MedPAC. It’s not entirely clear since the organizations that were able to lower the use of low-value care by and large choseto belong to an ACO so there may be something about the organization, not the ACO structure. The second option is to introduce cost effectiveness into determinations of Medicare payment.
MedPAC doesn’t explicitly endorse balancing cost and benefit in determining whether Medicare will pay for a service and if so, how much it will pay. It is at pains to review the long and sad history of attempts to introduce cost into Medicare’s decision-making. In fact, MedPAC includes a 14-page “primer” on Medicare’s decision-making process, with several highlighted sections on the failed efforts in 1989 and again in 2000 to use some form of cost-effectiveness. Both attempts were effectively derailed by the device industry that lobbied heavily against a strategy that they knew would result in restrictions on their ability to sell any device that is “safe and effective” (the FDA standard) at whatever price they wish.
But why, if including cost in coverage decisions is out of the question, does MedPAC go on and on explaining what cost effectiveness analysis is, reviewing the ethical objections to the use of QALYs (Quality-Adjusted Life Years), and detailing the history of efforts to define “reasonable and necessary,” the phrase used in the original 1965 Medicare legislation to describe what Medicare must cover? Why all the verbiage devoted to cost-effectiveness analysis in the commercial sector and by the non-profit Institute for Clinical and Economic Review? 
I have to assume that the reason is that the MedPAC commissioners recognize that while better physician education and new improved ACOs may be of some use, the most effective strategy is for Medicare to refuse to pay for “low-value care” when that is a euphemism for “useless intervention.” It is true, as the report indicates, that there is no explicit statutory provision including cost as a component of Medicare’s coverage decisions. But neither is there any statutory prohibition. It is time to try once again to exploit the loophole, perhaps using the language of “value” that is currently in vogue—after all, who could argue against choosing treatment that is valuable?

June 25, 2018

Reforming Medicare: Enhancement or Evisceration?

Recent reports indicate that Congress will try to slash Medicare in order to balance the budget—making older people and disabled people shoulder the cost of its enormous tax cuts. The proposed plan, according to the Washington Post, would extract $537 billion dollars from the Medicare program over the next decade. At the same time, the budget passed by Congress and signed into law by the president in February created CHRONIC (Creating High Quality Results and Outcomes Necessary to Improve Chronic Care Act) which, the NY Times suggests, is a hidden jewel buried in the voluminous budget bill. Which is it? Is Medicare headed for enhancement or for evisceration?

Thus far, the cuts are theoretical (it’s not clear that the House Budget Committee will get very far with its recommendations) whereas the reforms are real—or will be when they go into effect in 2020. CHRONIC is to be lauded for accomplishing several important goals. 

First, the act recognizes that good outcomes among people with chronic conditions are contingent on what are not strictly medical services—as well as access to physicians, hospitals, pharmaceuticals, and medical devices. Wheelchair ramps and grab bars, as well as other products that lie outside the traditional definition of “durable medical equipment,” can in the future be paid for by Medicare—at least by Medicare Advantage plans that opt to offer them. This strategy does not go as far as the National Health Service did in the UK with its “personal health budgets” that allowed patients or their representatives to decide in concert with their physicians how to spend their share of the health care pie. The result—and the program, despite some vocal protests, has been so successful that it was recently expanded—is that patients with early dementia can choose, for example, to spend NHS money on creating a garden that will keep them engaged, potentially obviating the need either for medication to control symptoms of agitation or for institutionalization in a nursing home. Nor does the US strategy apply to traditional Medicare: in an effort to make Medicare Advantage plans, which currently have 19 million members, even more attractive (furthering the Republican goal of privatizing Medicare), only MA plans will be allowed to reimburse for these new supportive services. 

Second, CHRONIC permanently authorizes Medicare Special Needs Plans (SNPs) that cater to the highest risk Medicare beneficiaries including those living in institutions. These are special types of Medicare Advantage plans that offer enhanced integration and coordination of care, a critical feature for this complex population. 

Finally, CHRONIC extends its support of non-traditional forms of care, of which the allowance for grab bars was one example, to telemedicine (particularly relevant for homebound patients and in rural communities) and to home care (expanding the Independence at Home Program 50 percent from 10,000 enrollees to 15,000). 

So, what’s not to like? Two cautionary notes. First cautionary note: CHRONIC focuses overwhelmingly on Medicare Advantage plans (which currently cover 32 percent of Medicare beneficiaries), not on traditional Medicare (which covers the other 68 percent). This is no surprise, as the Republican Congress, which is interested in privatizing Medicare, sees shifting to the MA model as a route to achieving this goal. In principle, I don’t have any problem with expanding the number of MA plans (currently there are 3300, according to MedPAC, the Medicare advisory council) as they offer great potential for the coordination of care so essential to frail elders, but it will be essential to maintain the regulatory oversight of CMS if these plans are to be guaranteed to provide quality care. Moreover, we need to begin collecting detailed data on the utilization and outcomes of MA members. Right now, almost all of the voluminous data gathering by the federal government exclusively deals with fee-for-service enrollees so no granular analysis of the performance of MA plans is possible. 

Second cautionary note: while some of the provisions of CHRONIC appear to address programs, in fact the legislation is often grounded in how the programs are to be reimbursed. And the underlying philosophy is that the way forward lies with “value-based” care. I’ve blogged about this before, most recently in my post “V is for Value.” My concern about this approach is that it assumes that better and less costly medical care can be obtained simply through tweaking reimbursement. It’s the triumph of the economists’ view of health care as an industry subject to manipulation like other industries. The trouble with this insistence that VBP is key to all our problems, aside from the fact that so far value-based reimbursement systems such as pay-for-performance have not succeeded, is that it discounts the role of culture, advertising, and popular expectations. It is these factors, and not just payments to physicians, for example, that shape the enthusiasm for technology manifested by patients, corporations, and physicians alike.

CHRONIC is an admirable piece of legislation—for what it includes. What should concern us, however, is what it leaves out.

June 20, 2018

Much Ado About CPR

Two short essays in this week’s New England Journal of Medicine present differing perspectives on how to treat a desperately ill woman w in the ICU of an American hospital, a woman who is unable to make her own decisions and has no advance directive. One author responded that the right course of action was to “institute a DNR order” and the other that it was to “continue full resuscitative measures,” setting up a quasi-debate. I say a quasi-debate because the two authors, as per the editor’s instructions, simply laid out their own arguments without responding to the other’s point of view. I know, because I am one of the two.

I asserted that the physician should declare the patient DNR—a woman with no written advance directive and no designated health care surrogate who was dying of multiple organ failure triggered by sepsis and unresponsive to maximal medical therapy. Attempted CPR in this setting, I argued, was as close to futile as medical treatment ever is; moreover, the patient had clearly stated to a friend and neighbor that she would not want aggressive measures when facing overwhelming odds. I stand by my arguments, which I won’t repeat here, but I regret that the discussion focused on the wrong question.

The wrong question is whether the patient should have a DNR status; the right question asks about the general treatment strategy rather than a specific medical intervention and about the process for deciding, not just the outcome of the process. It moves the discussion beyond considerations of futility—a debated that raged in the 1980s and ultimately led to the recognition that futility is meaningless without reference to what treatment is intended to accomplish. Maintaining a patient who is in a persistent vegetative state on artificial nutrition is futile if the goal is to restore her to full functioning as a thinking human being. But it’s entirely appropriate if the goal is to sustain life in the sense of a heart that beats and lungs that respire. Discussing how to make medical decisions for patients who have lost capacity and how to think about treatment for those who are dying allows us to discuss much more important decisions than whether or not to attempt CPR.

Ever since 1984, when a New York hospital was found guilty of putting purple dots on patients’ charts signaling that they were not to be resuscitated—without their knowledge or input or that of their next of kin—we’ve been obsessed with DNR orders. I suspect that more ink has been spilled on whether, when and why to write a DNR order than on any other medical decision. The reason, presumably, is that it seems irreversible: if a patient sustains a cardiac arrest and CPR isn’t performed, the patient will surely die. Other seemingly momentous decisions often prove not quite so momentous—even Karen Ann Quinlan, the first patient to bring the possibility of not intervening medically to public attention, lingered for nine years after her “life-sustaining” ventilator had been disconnected. A choice not to resuscitate is far more unambiguous—although CPR, it should be pointed out, is hardly a guarantee of life.

Cardiac arrest may have special cachet because it seems to divide the living from the dead. But in fact, for older patients who are critically ill, it is often merely the last step in what is often a relentless progression of markers on the way to death. From the perspective of human suffering and of doing good (and avoiding harm), other steps along the way are often far more significant. After all, a person whose heart has stopped and who is not breathing is no longer able to experience anything, neither the existential angst from awareness of imminent death nor the physical discomfort of aggressive treatment. The nurses and doctors who attempt CPR in a dying patient may feel guilty of assault; they often regard intubation, chest compressions, and electrical shocks as an undignified way to end life, but they are the ones experiencing malaise, not the patient.

Subjecting a patient who is in the final phase of life to dialysis for four hours a day, three times a week, or to major surgery to repair a damaged heart valve, or to ventilator care for advanced lung disease, by contrast, may cause pain and suffering to the person receiving treatment. Both the potential benefit of treatment (longer life) and its potential burdens (ranging from delirium and functional decline to a shorter life) are difficult to assess quantitatively. These decisions, which are difficult to make with a competent patient and correspondingly more fraught with an incapacitated patient, are the ones we should be discussing, not CPR.

Ironically, despite the now 42-year history of DNR orders, there is still confusion about whether DNR indicates that CPR will not be performed in the event of a cardiopulmonary arrest (as it is defined by the American College of Cardiology and other authorities) or something more. Indeed, the opposing piece in the New England Journal of Medicine talks about a time-limited trial of “continued resuscitative measures,” which presumably refers to ongoing ventilator treatment for respiratory failure, dialysis for kidney failure, and fluids and antibiotics for sepsis, rather than for a few minutes of attempted CPR. This uncertainty about what DNR means reflects another problem with the obsession with “getting the DNR order,” and that is the widespread belief that treatment decisions must be all-or-nothing: if you don’t want CPR, then surely you don’t want any potentially life-prolonging medical interventions. The reality is that many people don’t want burdensome treatments that are extremely unlikely to be beneficial, but that doesn’t mean they want to focus exclusively on comfort. 

There’s much more to discuss—I haven’t even touched on the process for making medical decisions. That includes not only who the surrogate should be in the event of decisional incapacity and what standard that surrogate should use for making decisions (substituted judgment is the usual standard, with best interests the back-up if no information about the patient’s preferences is available), but also how the discussion should unfold. Typically, physicians are so eager to reach a decision about what to do that they jump to this step in the process without first clarifying the patient’s underlying health state (in the NEJM vignette, the crucial bit of information is that the patient was dying), as though preferences are independent of any broader context. But for now, let me leave you with the thought that both medical decision-making and advance care planning involve much more than checking off items on a menu, and that if we do engage in intervention-specific planning, CPR should be low on the list of what we discuss.

June 07, 2018

The Sting of the Jellyfish

Several years ago, the public health community launched an initiative to persuade pharmacies to stop selling cigarettes. Responding to steady pressure, CVS announced in 2014 that it was pulling all tobacco products from the shelves of its approximately 7700 stores. The result? Overall sales of cigarettes dropped, with fewer teens starting to smoke and more people quitting. The other chains, such as Walgreen’s and Rite Aid, have not yet followed suit, but the precedent has been set: retailers dedicated to the promotion of health should not be in the business of peddling death—and cigarettes are the leading cause of preventable death in the U.S., accounting for over half a million deaths per year.

In the same vein, we might ask why news organizations that are dedicated to ferreting out the truth continue to allow ads that peddle falsehoods. And that’s exactly what CNN, Fox News and MSNBC are doing when they advertise Prevagen, a protein that its manufacturer, Quincy Bioscience (a company that seems to be devoted almost exclusively to making and selling Prevagen) touts as “clinically shown to improve memory,” exhorting aging individuals to “try Prevagen for yourself today” in order to “support healthier brain function, a sharper mind and clearer thinking.”

These claims are untrue. The FDA issued a warning letter to the company in 2012, arguing that the company’s unverified health claims indicate that it is selling a drug and not a “supplement” (as the company calls Prevagen) and thus must go through the rigorous approval process for new drugs. Today, the manufacturer continues to call Prevagen a “supplement” because it is a synthetic version of a protein found in jellyfish and continues to make the same claims about its effectiveness, though with the disclaimer in small print that “these statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat cure or prevent any disease.” 

In 2016, the Federal Trade Commission’s Bureau of Consumer Protection and the NY State Attorney General filed a lawsuit arguing that, contrary to its manufacturer's claims, Prevagen has not been shown to improve memory in 90 days; it has not been shown to reduce memory problems associated with aging; and it has not been shown to produce other cognitive benefits.That lawsuit, incidentally, was dismissed because the judge failed to understand that the methodology used in the clinical trial on which the company’s assertions are based is irredeemably flawed. With the added support of AARP, the case has been appealed to the Second Circuit Court of Appeals. 

Why anyone should be motivated to take Prevagen based on its activity in jellyfish, which are not known for their cognitive abilities, is a mystery to me. 

Why anyone should think that the active ingredient, Apoaequorin, could possibly do anything when it is destroyed in the stomach by the enzyme pepsin and therefore doesn’t even make it into the circulation is another puzzle. And why anyone should believe that Apoaequorin could affect brain function (if it somehow managed to elude stomach enzymes and find its way into the blood stream) when it is 40 times too large to cross the blood-brain barrier is also unknown. But what is clear is that Quincy Bioscience has been successful in earning $165 million between 2007 and 2015. It is willing to spend big bucks on advertising on national television to promote its product because it knows the strategy works.

Followers of CNN, MSNBC, or Fox trust the news they hear from commentators on those stations. Because they trust the station, they tend to trust its advertisers. News programs have an ethical responsibility to vet the ads they run; they don’t have to like the products, they don’t have to want the products themselves, but they should be committed to fact-checking their veracity.

A separate question is why FDA regulation of “supplements” is confined to assuring that they are accurately labeled—that is, that the ingredients are correctly listed on the bottle. Manufacturers of dietary supplements do not have to prove them safe nor do they have to make claims about efficacy that are accurate or truthful. A related question is why products such as Prevagen can bypass the FDA's regulatory process for new drugs by calling themselves “supplements,” a term primarily applied to vitamins and minerals but increasingly used for all sorts of “herbs and botanicals” as well as other substances found in nature, or their synthetic analogs. 

In today’s anti-regulatory climate, we cannot realistically expect increased government protection for vulnerable consumers. We can expect—and demand—ethical behavior from any organization dedicated to promulgating the truth.