Categories

Tag: Policy

POLICY: On von Eschenbach’s appointment, by Gregory Pawelski

Greg Pawelski with a view on the new head of the FDA

More and more physicians and patients are turning to individualized therapies to treat cancers. Under this approach, scientists study how an individual’s cancerous cells respond to several drugs. Doctors have learned that even when the disease is the same type, different patients’ tumors respond differently to chemotherapeutic drugs. Treatments need to be individualized based on the unique set of molecular targets produced by the patient’s tumor, and these important treatment advances will require individualized assay-testing which can improve patient survival in chemotherapy for cancer. Assay-directed chemotherapy is an individualized approach to killing cancer. It’s time to set aside empiric one-size-fits-all treatment in favor of recognizing that breast, lung, ovarian and other forms of cancer represent heterogenous diseases, where the tumors of different patients have different responses to chemotherapy. It requires individualized treatment based on testing the individual properties of each patient’s cancer.

From yesterday’s Associated Press article:

WASHINGTON (AP) — The new acting   chief of the Food and Drug Administration says he will be presiding over a   transformation in medicine as scientists come to understand diseases in a more   detailed way that could improve doctors’ ability to treat patients.   

Now,"We are discovering so much about diseases like cancer at the molecular   level,"said von Eschenbach, a urologic   surgeon by training. "Much of what we have  done … has been based   on a model of empiricism." Soon, doctors will be able to intervene with   medical treatments more effectively matched to a specific patient’s illness.   

Read the rest at USA Today

Dr. Andrew C. von Eschenbach, tapped by President Bush as the temporary   chief of the regulatory agency, said Sunday that discoveries about diseases at "a molecular level" will lead to a new kind of health care. Doctors treat illnesses based on how well other people have   responded to a given treatment. Soon, they will develop a tailored response  built around specific understandings of the patient, the treatment and the   disease, he said.   

PHARMA/POLICY/POLITICS: Well at least he gets to put “former FDA Commissioner” on his resume!

So just like that after a contentious time getting confirmed, FDA Commissioner Lester Crawford resigns, after only formally being in the job for less than three months (although effectively having basically run the agency for three years). I wonder what further skeletons have crawled out of his closet?

Get ready for more confirmation fatigue as the Administration searches for someone else ready to screw their reputation by placing politics (and deeply unpleasant, mean spirited politics at that) before science.

POLICY: Enthoven on the rational place for consumer choice in health care, and why CDHC is missing the point

It was a little while back that I heard a webinar from Michael Porter, and I described him as the next great business school professor to get lost in the health care quagmire. At Stanford Alain Enthoven has been stuck there for many, many years, (mind you, so am I!) but he at least has a deep and systemic understanding of how health care works, and how it could work better — even if he never enjoyed the satisfaction of seeing his ideas adopted on a national scale. You’ll recall that some of his ideas were at least partly behind the Clinton plan. (Incidentally Porter was pretty dismissive about Enthoven in the Q&A section of his talk). After I wrote my article (and another on Regina Herzlinger) I got some complimentary email from Enthoven, and I suspected that he wasn’t going to let the "consumer-directed" academics have it all their own way.

His response to Porter et al (with Laura Tollen from Kaiser Permanente’s Research Institute) is in an article at Health Affairs (free in its web only edition) called Competition In Health Care: It Takes Systems To Pursue Quality And Efficiency. What he does is to analyze what we need to do to create a rational market in health care, and then contrast that to Porter’s suggestions.

First up. Will high deductibles and personal HSAs really act as a market force on providers’ behavior?

Porter and Teisberg’s answer to these failings of the FFS indemnity system—“reasonable copays and large deductibles combined with medical savings accounts [that] would let patients take some financial responsibility for their choices”—is insufficient. Copays give patients some responsibility for the frequency with which they demand doctor visits but leave them insensitive to the costs of services provided during those visits. Deductibles aren’t a solution because health care expenses are concentrated among patients whose costs exceed reasonable deductibles. By most estimates, the most costly 30 percent of patients account for 90 percent of total health care spending.

This kind of insurance leaves patients cost-unconscious once they anticipate reaching the deductible or out-of-pocket spending limit. Coinsurance helps, but only to the point where limits on out-of-pocket spending—typical in most health insurance arrangements—are reached. Ironically, though, it is the very people who will exceed these limits (those who need expensive treatments) for whom Porter and Teisberg expect regional centers of excellence to compete on cost and quality.

Bingo.  Nothing more needs to be said, and I have never heard anything from the pro-HSA/personal account crowd explaining how to deal with that issue. Meanwhile despite the pro-consumer directed lobby’s idea that information is all that is needed it’s clear that information is necessary but not sufficient. Enthoven gives a couple of examples of why incentive change is needed for the information availability to work:

First, the most high-profile CABG patient in the nation—former President Bill Clinton—chose to undergo this procedure at New York–Presbyterian Hospital/Columbia University Medical Center in 2004, although this hospital ranked twenty-second in risk-adjusted CABG mortality rates among thirty-six hospitals performing the procedure in the state. In a more disappointing example, the Pennsylvania Health Care Cost Containment Council published a consumer guide to CABG surgery with risk-adjusted mortality data. In a random sample of 50 percent of Pennsylvania cardiologists, 87 percent said that the guide had little or no influence on their referral recommendations.If referring cardiologists do not use this information, it is unlikely that patients will. Although it is important to provide this kind of information, much more work must be done to make it useable for patients.

And then there’s the key issue of how to manage the chronically ill — the ones who we spend 70% of the money on — using care coordination between providers.

Under a completely free-choice model such as that of Porter and Teisberg, a patient with diabetes would seek out the best providers for diabetes, and a patient with congestive heart failure would do similarly. Putting aside doubts that ill patients will regularly travel far from home to centers of excellence, the problem remains: Many patients have multiple chronic conditions. In addition, people with chronic illnesses also need primary care. It simply cannot be good medicine for people with multiple chronic diseases to receive primary care and care for each of their conditions in separate locations, with different sets of doctors who don’t communicate regularly about the patient.To be fair, under the provider-level competitive model, one could imagine regional specialty centers that treat a variety of conditions that often coexist with one another (for example, the diabetes center would include experts in hypertension and heart disease). However, this raises the question of whether there are natural limits to the expansion of that expertise that stop short of a fully integrated delivery system. We do not think so.

Enthoven has me convinced that structured provider systems with virtual or real integration and their incentives alignment to produce the best care at a defined price per capita are the best way to deliver medical care to populations. That was the original goal of the HMO movement, even though it was destroyed when the HMO went from being a real organization to being just another insurance product for benefits consultants to sell. So why did this all get thrown out with the bathwater in the managed care backlash? Enthoven again gives the right answer, and this is confirmed by survey data from Harris that I was using at the time in the mid-1990s.  People wanted a choice, and when they were forced from free-to-them open access to managed care plans that used the same doctors but paid them less and pissed them off (the doctors that is), they didn’t like it. My doctor use to call PruCare (Prudential’s HMO "ZooCare") and I’m sure his patients noticed.  Enthoven is correct when he explains the consequences this way.

Conventional wisdom now has it that people don’t like managed care. The more nuanced truth is that they don’t choose managed care when their employers pay practically the full premium of whatever they choose. Then, there is little to be gained financially by accepting a limited provider network. In contrast, when employers pay a fixed-dollar amount and each employee can keep the full savings, experience shows that high percentages of employees choose economical care. For example, 70–80 percent of active employees and dependents covered by the University of California, CalPERS, and Wells Fargo in California choose HMOs.Another reason markets have not produced competition among IDSs is the widespread employer practice of offering only one insurance carrier, which, in turn, offers only one delivery system (although this is changing; see the discussion of tiered networks below). Seventy-seven percent of insured employees are offered only a single carrier.

So you can get consumers to make a choice within the context of real differences in the insurance product that they buy. But in a world where that’s going to work you really need to have organizations affiliated with the insurers that can actually manage the kind of team-based, guideline-driven medical care that is needed.

For a delivery system to market its superior efficiency, it usually needs to be affiliated with its own or a partner carrier. Thus, offering different carriers is a necessary but not sufficient condition for competition among delivery systems. Ten carriers all offering every FFS doctor in town is not competition, nor is one carrier offering three plan designs (HMO, PPO, point of service), all using the same doctors. Competition to serve whole employer groups on a single-carrier basis has historically resulted in all-inclusive networks. But for these to be effective, carriers must select providers based on quality, efficiency, and willingness to work in teams and with evidence-based guidelines. However, people want to choose their own doctors. In a world of competitive delivery system–based managed care, therefore, people must have a choice among managed care organizations as well as “unmanaged care”—if they are willing to pay the excess cost

In other words there needs to be a cooperative arrangement between payer and provider, and probably an exclusive one too. Sadly for all of us, that only appears to exist here in communities and states where there’s a long history of it (e.g. urban areas of California, Minnesota and Seattle). Otherwise managed care is the same gong show as FFS, with the money going to different places (insurance executives rather than specialist physicians).

Of course the overall problem that I fear Enthoven has shrunk away from over the years is that creating this kind of an incentive structure means creating an environment where consumers/employees/enrollees pay for membership of a system, and have the tools to judge whether that system is worth the extra money they need to pay for it at an open enrollment period. To my mind that really necessitates putting all small and medium businesses into a buying pool, And not just that. But now you need to know a little about buying pools, and I’ll use an example that I know well. Me.

I’m in a buying pool that called PacAdvantage, and it gets me a high deductible "non-system" plan from Blue Shield for about $200 a month; if I bought that same plan via eHealthinsurance.com it would be about $80 a month, until Blue Shield notices (as it did) that I had had knee surgery a few years back and was probably going to have knee problems again, and the price went up to over $400 a month. Of course for that price I could probably buy into an HMO with better coverage if it wasn’t using underwriting, but then again I probably wont use $400 a month’s worth of care (unless I have more knee surgery) so what would be the point?

What’s behind all my quibbling?  In the buying pool get a huge choice of benefit packages, and I will tailor the one I want to my situation. If I can get a better deal outside the pool I’ll take it. So inevitably the pools/buying groups will attract the sicker people (i.e. those who think they will have high health costs) and the healthier ones will take their chance on the individual market and increasingly on high-deductible plans, perhaps with an HSA attached. And of course those high-deductible plans won’t let in anyone who may be sick.  (Our good buddy Ron’s latest commercials which he sent me all state clearly that "medical underwriting is required")

So we have to bite the bullet here. If this is going to work to create the level playing field for integrated provider systems to compete on everyone has to to in a buying pool of some type, and the buying pools must offer the same benefits package. There must also be (as Enthoven mentions in the Oregon BENU pool) real-risk adjustment between the insurers so that they are dealing with the same level of acuity in the population. If that were to happen, and people were to choose their IDS (and plan which would be essentially the same thing) based on a combination of value for money and what trusted authorities (not that they exist here yet) say about their ability to deliver the co-ordinated, cost-effective, informed and evidence-based care that Enthoven’s talking about, then you’d slowly see a market driven alignment of providers to serve that outcome.

We are of course miles away from that outcome, and let’s not beat around the bush here. That arrangement is so close to a single payer universal insurance system that its opponents are able to tar it with the same brush. Enthoven objected to the Clinton plan mostly because it put Medicaid into its big buying pools. But, in the end, everyone has to go into them if this system is going to work–it cant be restricted just to the small business part of the commercial population and "everyone" includes Medicaid, Medicare, the uninsured and everyone else apart from possibly big businesses and the very wealthy. And that is of course how it’s done in Japan, Germany, and most other countries that use this type of a group approach to buying health care (And by the way their governments all also regulate price and provider supply).

And this intellectual "big tent" isn’t so crazy. After all it’s only in the UK where Enthoven’s ideas have ever been implemented at a policy level, and they were moving away from pure global budgeting single payer to an "internal market". Policy wise the "voucher/buying pool" group and the single payer group are so much more aligned than the other side, which really doesn’t give a rat’s arse about care quality or universal coverage. So given that the non-sense of Porter, Herzlinger and the Galen crowd is in the ascendancy, even if it doesn’t cure any of our fundamental problems and probably makes them worse, can we get Alain over to join in a truce between the "voucher" crowd and the "single payer" crowd.

POLICY/HEALTH PLANS: What to do about coverage in Katrina’s diaspora

Ezra Klein has an article up the thorny problem of how to get health coverage or continue it to those who have been displaced. Ezra suggests extending COBRA to all of them. The major problem there of course is that proving who worked where is going to be a nightmare, and with no income many people won’t be able to afford COBRA (or any other kind of insurance, just before you jump in Ron!), and those employers that won’t survive Katrina or which are already effectively finished, will not be able to make their monthly premium payments — which will at some point mean the end of those employers’ plans for ex-employees to buy into using COBRA. This solution may though work for those who have stable employers and have coverage that the employers are continuing to pay for while they’re effectively laid-off or have the money to buy an extension of that employer’s coverage (even if the employer itself is no more) if the insurers can be persuaded to allow that (which I’m sure under the circumstances they can).

For everyone else (which is probably the vast majority)  Ezra basically suggests what seems to be the current prevailing thought. Let those people go on Medicaid in whichever states they end up and let the states make sure that the Feds pick up the tab as part of the overall disaster relief effort as promised.

Of course this is one more reason why a simple national universal insurance system would be a better way of handling things. If everyone was covered then providers could give services in the certainty that they’d get paid. Don’t forget that this will be the situation for those who are over 65, as Medicare is a national system (albeit administered regionally).

And at the least Katrina has uncovered the ugly secret of what it’s like to go without in America today….and going without health care coverage is a big part of going without.

PHYSICIANS/POLICY: Another Podcast with Eric Novack

So here’s another podcast recorded at the tail end of last week with me chatting with surgeon, talk radio host and "free-market" advocating surgeon Eric Novack. This one focuses on why health care costs so much and why we can’t stop physicians behaving badly. We discuss evidence-based medicine, managed care, capitation, end of life care, practice variation, and defensive medicine — and it’s still incredibly civilized. Don’t worry — we’ll keep having these talks until we really start laying into each other!

Here’s the MP3 to download (this one’s a little over 30 minutes listening time). Enjoy and please tell me what you think

.

HOSPITALS/POLICY/INDUSTRY: Katrina and the response

We have all been shaken by the devastation in New Orleans and the Gulf Coast. After a couple of days to reflect, three thoughts come to my mind. First has been the absolute heroism of health care workers in New Orleans, and those helping from neighboring areas. The tales of nurses, doctors and other workers keeping patients alive by hand-pumping ventilators, and performing near-miracles in conditions that none of them could have believed they’d ever have to work in reminds us that medicine and health care is a calling far more than just a job. Second, the time for investigations and blame if any will come later, but it’s beyond belief that it’s taken this long to get either food, water and medicine into New Orleans, or those stranded people out. Finally, it can’t have escaped anyone’s attention that the vast majority of those "left behind" are poor and African-American. And that’s a microcosm of what’s going on in our society and in our health care system. Hopefully this disaster may give us a chance to reflect on that and to make some changes.

I linked to the Red Cross earlier this week, but Instapundit has a long list of other charities who need help.

PHARMA/POLICY/POLITICS: FDA Official Quits Over Delay on Plan B, with UPDATE

The FDA official in charge of women’s health quits over the delay on Plan B‘s approval. Well it’s good to see that some of the staffers left at FDA have some spine, because it’s clear that, whatever the lies being told by the Administration, this is all about cow-towing to the loonies on the Christian right rather than the science of the situation.

There are a couple of telling shots in the story. Crawford swore up and down that this was his decision and that it was a science-based one.  Not so. 

Susan F. Wood, assistant FDA commissioner for women’s health and director of the Office of Women’s Health, said she was leaving her position after five years because Commissioner Lester M. Crawford’s announcement Friday amounted to unwarranted interference in agency decision-making. "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she wrote in an e-mail to her staff and FDA colleagues.

Of course there were strenuous denials from all concerned, but what was she told?

Wood also said other FDA officials who are typically involved in important matters were kept in the dark about the contraceptive, called Plan B, until Crawford announced his decision, which she believed was made at higher levels in the administration. Wood said that when she asked a colleague in the commissioner’s office when the decision would be made, the answer was, "We’re still awaiting a decision from above; it hasn’t come down yet."

So you could argue that this was not Crawford doing what he thought the loonies wanted him to do, but instead he was actually taking instructions from Leavitt or Rove or whomever.  On this issue  they can send a sop to their "social conservative" friends. After all it’s only a small pharma company they’re pissing off here, not a big one, Just as well Lipitor doesn’t impact birth control, eh?

Meanwhile, there’s just a delicious piece of doublespeak from Leavitt that really outdoes some of the stuff we’ve had to put with from Rumsfeld over the years:

Many supporters of the Plan B application — including Sens. Hillary Rodham Clinton (D-N.Y.) and Patty Murray (D-Wash.) — accused Crawford of making a political decision that ignored science and public health. The two senators were especially angry at Crawford’s ruling because they had lifted a hold on his pending nomination based on promises, relayed by HHS Secretary Mike Leavitt, that the Plan B issue would be resolved by Sept. 1.

Clinton and Murray have accused the administration of breaking its promise, but Leavitt has disagreed. "The commitment was they would act," he told Reuters on Monday. "Sometimes action isn’t always yes and no. Sometimes it requires additional thought.

So now when you’re asked by your wife, boss, teacher, whomever why you haven’t done something you were supposed to have done (you know, "taken action") you can tell them that you were thinking about it and that is exactly the same thing! Not only that — it’s now official policy in what passes for the circus we call a government.

UPDATE: Bob Steeves points me to this quote from the spokesman for Mike Enzi (a Senator with an "R" after his name), showing that he didn’t get the Talking Points on this one and looks a little pissed:

Sen. Michael B. Enzi (R-Wyo.), chairman of the Health, Education, Labor and Pensions Committee, is considering whether to hold hearings on the FDA’s handling of Plan B, said spokesman Craig Orfield. Enzi had expected "a firm decision" from the FDA, not further delays, Orfield said.

assetto corsa mods