The National committee on Quality Assurance (NCQA) has new report out that funnily enough contrasts strongly with the report from the Harvard academic physicians that I was somewhat cynical about in this post yesterday. NCQA’s mission is to improve health care via greater accountability and information. Although it’s directors and staff tend to come from the payer rather than the provider side, and its money comes from Foundations and the pharma industry, it has worked hard to maintain academic independence. In my view they have been telling the truth about health care quality all along — really all they have to do is point out the obvious.
Anyway, enough editorial, the NCQA’s State of health Care Quality report details what many of us have know for many years. In order to treat heart disease, diabetes, asthma, etc, etc, etc, as John Mattison from Kaiser told me many years ago "We know what to do, we just don’t know how to make sure it gets done." The consequence of practice variation away from best standards of care, according to the Peggy O’Kane, NCQA’s President, is "More than 57,000 people will die this year because there is a huge gap between what we know and what we do." There’s also some 41 million sick days and billions in wasted expenditure ($1.6 billion for heart disease alone). None of this is news, John Wennberg’s Dartmouth Health Atlas has been detailing the extent of practice variation for decades.
The one area where NCQA says there has been improvement is among those health plans where they are actually measuring the impact of treatment protocols. (The report cards that NCQA promotes are part of that effort). Of course, none of this much matters if providers are not being rewarded for improving care quality. In fact since the "end of managed care" (see my earlier post), the quality improvement movement has been struggling, even though some plans are now paying bonuses based on quality. In the end the biggest payers (i.e. Medicare, Medicaid, FEHBP) and the government (i.e. Medicare, Medicaid, FEHBP) must come together to promote compensation for quality if we’re ever going to make progress. And as shown in the recent JAMA article, the provider industry has plenty of fire power with which to resist.
Drug imports from Canada are now being stopped at the border. We’re already had Glaxo trying to cut the Canadians off at the wholesale source (later joined by Pfizer). Now we have the FDA trying to shut down a major exporter, claiming that its Insulin was not delivered frozen. While this is going on, the state of Illinois was telling its retirees to look north for their drugs.
This long article in the Boston Globe, which I got to via the excellent Bloviator medico-legal site, suggests that the crux of the FDA’s case is that insulin and some other drugs need better care (i.e. temperature controls) during transit. Even if that’s true for safety reasons, it is a) equally true for US based mail-order pharmacies and b) probably not true for most drugs sent in pill-boxes. In fact the Canadian Internet pharmacies are bending over backwards to do this properly. Look at this example. You need a new Rx script from a real American doctor. While, if you want to buy Viagra online from this American source, you just need an "online consult."
So why the crackdown on the Canadian imports only? Let’s take the FDA at their word for the moment and realize that they are where the buck stops for patient safety. But if the FDA is trying to avoid appearing to be the handmaiden of PhRMA, it needs to work on its PR a bit more!
So the quality movement has been making slow strides and the first vestiges of a pay for performance system has appeared in California and has been going for a couple of years in Massachusetts. But not so fast! You may (as I did) have missed, while you were recovering from your labor day exertions, the September 3 JAMA article from several leading Boston doctors which explained that pay for quality and performance won’t work. (You can see the abstract here). I quote a chunk of their press release below so you get the idea:
"Measuring a physician’s quality of care by numerical standards — such as adherence to a disease management protocol or a treatment outcome — is often invalid for a variety of reasons, say the authors of a study in the Sept. 3 Journal of the American Medical Association.
While not a general nationwide practice, several payers around the country are using quantitative quality measures as a basis for reimbursement bonuses (for Blue Cross and Blue Shield of Massachusetts’ program, see MD Practice Alert, July 30, 2003). Some medical groups also reward higher quality with higher pay. "Quality" for such incentive payments usually means adherence to well-recognized disease management or preventive care protocols or procedures. Quality measured in this way is beginning to be available on some Web-based "physician report cards" that increasingly may be the way some patients, such as those on consumer-directed health care plans, choose doctors.
Bruce Landon, M.D., researcher at the Harvard Medical School Department of Health Care Policy, and lead author of the JAMA study, says that although it looked at the use of such quantitative measurement (also called "physician clinical performance assessment" or PCPA) for credentialing doctors, many of the cautions raised in the study "are relevant for ‘paying for quality.’"
While PCPA can be valuable and is improving, Landon and his co-authors say, it has several common problems, some of which are:
–Insufficient sample size in an individual doctor’s practice. The authors suggest that 100 patients may be an appropriate sample (patients with the same disease treated by the same physician), but note that the National Committee for Quality Assurance says a 35-patient sample is adequate. "The proportion of all physicians for whom sample sizes are large enough to permit valid PCPA is unknown at this time," Landon writes.
–Systematic differences in populations of patients, who may differ in adequacy of insurance, general health status and other ways. "Health plans typically don’t adjust for health status or sociodemographic characteristics," Landon notes, although their reimbursement bonuses deal with patients who have the same insurance. To solve the problem of differing health statuses, some PCPA measures may include only "ideal candidates," he adds, but that approach could create sample-size problems.
–Poor reflection of entire practice. Obviously, adherence to one or two protocols is only a small part of what any given doctor does. Studies have shown that adherence to one protocol is a poor predictor of adherence to another not used to evaluate physicians.
Cost. "Collection [of PCPA data] in the outpatient setting would be substantially more expensive [than collecting valid hospital quality data] because of the multiple different locations and lack of funding mechanism to pay for this type of performance assessment activity," Landon says.
–Potential conflicts with quality improvement. PCPA activities may differ depending on whether they’re conducted to assess physicians’ competence or to foster quality improvement. Conflicts with patient communication and other unmeasured aspects of care also could arise, he adds. Groups focusing on a given kind of quality improvement "might pay less attention to other important features of quality that are not being measured."
–Lack of evidence-based measures for many specialties.
–Challenges in defining minimum thresholds for acceptable care.
"Many health plans," Landon says, "use arbitrary thresholds (e.g., the top 25%), when in fact there might not be much difference [in performance] between those that receive the bonus and those that don’t." Lack of uniformity among payer bonuses also is a problem, he says. "There are often so many measures from different plans that the signal to increase quality can get lost in all the noise."
The last two sentences of the abstract indicate that they are not happy with the ways they are being assessed. "We conclude that important technical barriers stand in the way of using physician clinical performance assessment for evaluating the competency of individual physicians. Overcoming these barriers will require considerable additional research and development." And their last sentence is a thing of beauty. "Even then, for some uses, physician clinical performance assessment at the individual physician level may be technically impossible to accomplish in a valid and fair way."
Matt Quinn, who’s been working in health quality data assessment for some years now, and who’s vigilance saved me from missing this work of art, commented. "I guess that means that efforts to measure performance and inform consumers just aren’t worth it and that everyone involved should just continue to assume that all docs provide consistently excellent quality care that adheres to evidence-based guidelines." I’m sure Matt would agree that the correct performance assessment of no other human process has ever had to overcome this magnitude of challenge!
I’m reminded of Gene Wilder as the sheep-loving struck-off MD in Woody Allen’s film Everything you ever wanted to know about sex but were too afraid to ask. He’s working as a waiter and when too many customers start complaining and it all gets too much, he shouts "Don’t treat me like that–I’m a Doctor! I’m a Doctor!"
Often those of us who’ve concentrated on IT, health delivery and pharmaceuticals forget the huge amounts spend on medical devices. Some of those medical devices are very expensive and in some the technological arms race is faster and has as much impact as that in the pharmaceutical approval war. The battle over coronary stents–tiny tubes that keep blood vessels open after angioplasty– has become bigger and bigger over the past few years. This is notwithstanding the opinion of a Canadian health services researcher I met a few years back who’s research "proved" that they had no real incremental value over straight angioplasty. But then we never cared about health services research or Canadians!
The latest development in stents is coating them with drugs to prevent scar tissue building up around them and necessitating more surgery. J&J’s market leading Cypher stent has it and as does Boston Scientific’s new market entry Taxus (selling in Europe and looking likely to be approved later this year for the US). The news that Taxus’ approval was in the offing led Boston Scientific’s share price to jump even after a big rise already this year.
The stent market has been an ongoing battle, as this Businessweek article shows, for many years, and now is a $5 billion worldwide market–split usually between J&J, Boston Scientific and Guidant. Who gains and loses the lead in market share changes over the years depending on who has the latest gizmo, and who’s sales staff impresses the surgeons the most. But the combination of drugs and devices is a trend that is going to have staying power.
According to consulting firm Cap Gemini E & Y, health plans really are spending twice what they spent in 1999 on information technology. This report claims that plans are spending much more on IT in the areas of sales and marketing support, customer service, medical management underwriting and traditional back office stuff such as claims and enrollment.
I’m not sure what to make of this. Health plans are now at the top of the underwriting cycle (and hence are making beaucoup bucks, as this Interstudy report confirms) and so should have more money to spend on IT. Plus they have historically under-invested in IT. Meanwhile the rest of corporate America has stopped spending on IT after its binge of the 1996-2001 period, so it’s impressive that health plans are increasing their spending. Whether this "catch up spending" is enough to make up for their generally poor use of IT systems remains to be seen. And it further remains to be seen if they can handle the systems complexity involved in the move towards "consumer-directed health plan" products that several have announced, including the Oregon Blues.
Even though everyone’s back from the summer break, and even though both the Senate and the House have passed a version of the bill, it’s looking less and less likely to me that we’ll get a final Medicare prescription drug bill at all. The Democrats who agreed with Republicans in early July now see a President weakened by dropping public approval numbers, primarily about the economy, but also about the Iraq situation. So they’ve little incentive to allow Republicans to take credit for a domestic issue when most polls show that they are the party the people have most faith in on the home front. Added to that the middle to upper income retirees who forced the repeal of the last major reform, Medicare Catastrophic in 1989, are agitating again. Retirees with decent employer provided coverage are likely to see their employers drop it when Medicare provides it (and why wouldn’t they?). And the bill as currently written is OK if you use few drugs, OK if you have catastrophic Rx needs, but not much good if you are in the middle of the "donut". The NY Times has noticed that this is making many seniors very upset. As 2/3 of seniors have some drug coverage already, suggestions that it be replaced with something not as good will not make them happy–especially if it’s run by the government. (You may remember the famous quote from the senior in 1994 who told Senator John Breaux to "keep the government out of my Medicare"). Never forget that seniors vote in greater proportions than any other age group, and health care is their number one concern–oh and quite a few of them live in a place called Florida that seems to have had quite an impact in recent elections.
Meanwhile, if we don’t get Medicare Rx we will miss out on something in the House bill that would be a "good thing". Pushed heavily by ex-speaker Newt Gingrich, who told a Congressional committee in June that "the evidence that written prescriptions kill people is overwhelming", the House version makes electronic prescribing mandatory for the Medicare Rx program. The Senate version doesn’t. The AMA of course supports "the concept but not the mandate" (Yes, that’s the actual headline in the AMA news article!)
So if ePrescribing is on the verge of becoming a significant activity, albeit for a small minority of docs (as I described in a post last week), inclusion of a mandate for it in the Medicare bill would certainly push it over the top. But that of course depends on forces more powerful than those brought to bear by the e-Rx lobby, Newt or no Newt.
Jeanne Scott (of course!) has far more about the difference between the House and Senate Bills here, and informed comment on her odds of what’s going to come in her newsletter (sign up by asking Jeanne nicely here)
Much to my amazement SB2, the California "play or pay" bill passed the legislature on Friday and will probably be signed by Gray Davis before the recall. However it doesn’t come into effect fully until 2007, giving plenty of time for repeals, other bill creating loopholes, or alternative proposals. However, it’s remarkable how a bill with such big implications sneaked by with such little fuss. I guess we can blame Arnold!
Robert Mittman’s technology series in iHealthbeat covers Nano-technology in health care. Meanwhile, Tim Oren responded to my saying that I find it strange that "sensible business people vigorously defend their right to be gouged by the current health care system and call anything else socialized medicine" by writing:
"You might find me more sympathetic than you suspect on the problems, if not on the solutions. We’ve got an incentive system for medical R&D that encourages the development of diagnostics over therapeutics, and palliatives for chronic diseases of the well-off over actual cures for anything. We balance the majority of the global costs of that R&D on the backs of American employers and employees. We’re headed pell-mell to a future in which genomic/proteomic diagnostics will be able to tell us risk factors and disease onsets down to the individual level, destroying the traditional notion of insurance as a pool of unknown risks, long before there are genetic or other therapies to do anything about the problems. We’ve got a growing medical infrastructure capable of extending lives at enormous expense and often with dubious benefit to the patients; and growing expectations that all will have access to those capabilities, even as the less skilled and educated are unable to contribute enough to the society to fund that ‘social minimum.’
I’m just firmly convinced that single-anything is the wrong way out. Putting a government bureaucracy in sole control of either side is a problem – a way to stifle the innovation that might get us out of this mess eventually. Some of the hybrid public/private proposals kicked around over the last decade are at least worth the discussion – maybe some social minimum level publicly funded, privately administered, with a layer of private insurance and medical capabilities on top of it, that everyone would understand is ‘on your own dime’. Yup, a two tier system, but we’re there de facto anyway"
Now I agree with virtually everything in Tim’s analysis of the system’s problems but thus far "innovation" in medical care have just given us more costs down the road–as everyone gets sick and dies eventually. (Notwithstanding the fact that many of these innovations obviously improve quality of life and save individual lives, even if many of them don’t stand up to rational cost-benefit analysis). Which is why I believe that we should put all the costs under one central line item and have a real debate about what we should spend and how. (I also know that we won’t have that debate, despite the urging of Humphrey Taylor at Harris, because it necessitates use of the term rationing!).
But what if there is a huge change going on? What if medical care became a real productivity enhancer and added to rather than subtracted from social capital–the way education does now? A pipe dream? Well probably, but if you read the nanotechnology article, this paragraph jumps out:
"Robert Freitas, the author of Nanomedicine, has designed (but not yet built) red and white blood cells and platelets–nanorobotic devices called Respirocytes–that will work 100-1,000 times better than natural cells. So for instance, you could sprint at full speed for 15 minutes. While this might make us all run like Carl Lewis, it would also enable extremely efficient removal of bacteria from the bloodstream. Imagine having one injection cure your flu within an hour. Freitas thinks that respirocytes are about 20 years away. Not much beyond that, perhaps another 20 years, is chromosome replacement therapy. Imagine taking several strands of DNA pairs from your body, matching the good ones, eliminating defects, and then manufacturing 4 trillion copies of that genome (you have about 4 trillion cells in your body). Put each into a nanorobot that would travel to each one of your cells and change the chromosome. With some other twists, the nanorobot would permanently rejuvenate you; no more aging."
That may just be science fiction, but if medicine really could cure disease and aging, then it would add tremendously to our social capital–because we wouldn’t have the long expensive periods of sickness that are associated with disease and old age. (How we’d die under this scenario is another question). Worth a thought, even if it’s far, far off.
CBS 60 minutes has an amazing story about a patient given a $1 million heart transplant at Stanford–who was a prisoner. The decision to pay for the transplant was made by the state prison system because it feared being sued by the patient’s estate. Too many lawyers? Apparently it’s part of the 8th Amendment. Has the prisoner got the same rights as anyone else or more? Would an uninsured patient get the same care? Unlikely, according to Dr. Lawrence Schneiderman, a medical ethicist at the University of California at San Diego, interviewed in the show, you may need to show that you have $150,000 in cash if you don’t have insurance. And the prisoner in question? He wasn’t a model patients and died shortly after the transplant. You can make up your own mind about this one, but it brings up all kinds of issues, and goes to show that health care is incredibly complex.