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PHARMA: The New York Times opinion on GSK and Spitzer

I’ve refrained from getting too much into the Spitzer versus Glaxo legal shenanigans over Paxil, and whether results were withheld deliberately or not. However, suffice it to say that yet again Pharma’s PR is not exactly going to be helping the Republicans in an election year when you see editorial pieces like this from The New York Times.

POLICY/HEALTH PLANS: What’s the end game of all these premium rises?

I spent the last couple of days at an IFTF conference which looked at impediments to improving health and creating a better health care system–a small topic as you may have guessed. I’ll report a little more about the conference in due course but one of the most interesting talks was from Brad Kimler from Fidelity Investments, who laid out then projected future costs of health care, and the consequent impact on what a couple retiring at 65 would need to have saved to pay their premiums for Medicare and cover their out of pocket expenses. The number was $175,000! And if you are 45 now, you’ll need $650,000 by the time you’re 65. And neither of these included long term care. In fact for a retired couple with a good pension plan, and retiree insurance from their company, by 2015 80% of their income will be going to pay their health care premiums. There was a certain amount of shock and awe around the room. While Brad admitted some self-serving interest in getting people to save more (and have Fidelity manage that process), we still have an enormous challenge facing us as a society. Currently the average 401K account retiree at Fidelity has under $100,000 in it, and of course there are no real funds in dedicated health care retirement accounts yet.

What’s even more intriguing is that Brad based his calculations on an 8% increase in costs. Of course recently we’ve seen even bigger increases in costs. Hewitt Associates yesterday came out suggesting that employers will face premium increases of up to 14%. Unless we generate some amazing productivity miracle and get much richer very quickly, there are only two ways that this can go, as the baby boomers start moving into their 60s (starting next year). Either we start dropping more people into un- or underinsurance, or we add more people to something like the Medicare program. That of course that eventually means either higher taxes for working people or lower incomes for the people providing health care services and products.

From the THCB Sacramento office Matt Quinn, who wasn’t at the conference, seems to be thinking in similar ways:

    Hewitt Associates estimates that health insurers will seek 14% premium hikes from employer groups, but probably won’t get all of it. The survey notes that all of the major insurers surveyed seem to be "pricing rationally": they are reflecting increases in medical costs as increases in premiums. And – at least before they get into negotiations with large employers – none of them seems to be playing the "take a loss / make it up on volume" ponzi scheme of the past. What the survey doesn’t note, however, is how much of these premium increases employers will pass onto their employees (or how many employers will simply drop coverage for some or all employees).

    So that leaves us with the current state of affairs: Employers (purchasers) expect to pay double digit premium increases each year, but can only "afford" single digit increases. Health insurers expect that their medical costs will increase at a double digit clip each year – and faster when the baby boomers hit. Hospital and drug costs are rapidly increasing, while almost all physicians expect – and most non-primary care physicians are receiving – annual pay raises. And consumers continue to want the "best" (i.e. newest and most heavily advertised) care at low or no cost.

    The recent CalPERS showdown with Sutter (and other "expensive" hospitals) illustrates the growingly activist role of purchasers in managing costs, but their efforts are clearly not stemming the tide. And, as we have seen at GE, SBC, and Safeway, employee tolerance for healthcare cost increases is quite low.

    I think that only one question remains: Who – other than the federal government – has the market clout to manage the cost and quality of care?

Several of the representatives from large employers at the meeting yesterday were starting to mouth the same opinion. Don’t expect anything big to happen with this Administration or Congress, so realistically even with a Kerry presidency this won’t be on the front burner till 2008-12. But absent a 1990s type productivity boom, this question is not going away.

PHARMA: Overdosing on ED

In case you were worried that Pfizer was losing some lead from its pencil–and there have been some rumors about new scripts for Levitra and Cialis doing pretty well– MedAdNews reports that apparently Viagra is staring down its rivals. Of course, there is some controversy, as has been replayed (to excess) over at the Pharma Marketing News list serv, that the number of men with ED in the US seems to be expanding to meet the number of men over 16 (100m was one number quoted!) but it does seem as though this "lifestyle" drug will remain a cash cow for Pfizer until it comes off patent.

PHARMA: The progress of reimportation, by The Industry Veteran

It looks like the Senate is going to pass the re-importation bill and then try to force the House to come on board. If, as I’ve been saying for a while, the Republicans are going to cave on this and do something before the election to preserve what little credibility the Medicare PDIMA bill has left with seniors, it’s worth thinking through what might happen next. Luckily for me and you, The Industry Veteran has already done so, so strap yourself in for a typically meek analysis of what’s going on. (Note that this piece is a couple of weeks old, as it was lost in my inbox mess on my vacation, but it holds truer today than when it was written!)

    Republicans in Congress have finally acceded to the public’s demand for ready access to pharmaceuticals reimported from Canada and other countries. HHS Secretary Thompson said he will advise George Bush not to oppose the effort. This means the President must focus his pharisaical, malevolent gaze at Hank McKinnell, Fred Hassan and the other plutocrats of Big Pharma and tell them that despite their $100 million contributions to his cloak-fascism-with-Christ administration, he has to look out for himself. In the short run this will provoke wounded howls and threats about the loss of high paying jobs, but Big Pharma is apt to remain one of the world’s most profitable industries. Organized medicine, for example, resisted Medicare from the 1940s through the mid-60s with shrieks about socialized medicine. As a result of LBJ finally getting the legislation through, physicians annual incomes rose from $50,000, respectable at the time, to the point where today, oncologists earn a median income of $450,000 and leave respectability behind them in the dust.

    The Republicans intent to actually permit some form of reimportation appears from the fact that their proposal was drafted by the Chairman of the Senate s Health, Education and Labor Committee, Judd Gregg, at the behest of the Senate Majority Leader, HCA’s Bill Frist. The legislation would permit transhipment from other countries, through Canada, providing: (1) the FDA can approve facilities through which the drugs pass and; (2) the tracking (or "pedigree") of shipments can be maintained.

    Some features in Gregg’s bill include:

    — Individuals can receive their prescription medications (a maximum 90-day supply at a time) from licensed pharmacies in Canada or up to 15 EU countries approved by the FDA. All businesses involved in reimportation must register with the FDA, submit to FDA inspections and must permit the agency to detain or suspend shipments in theinterests of public safety;

    –Internet pharmacies must comply with all current, federal, state and local regulations governing pharmacy practice;

    –Importers must identify entry ports, provide advance notice of incoming shipments, and grant the FDA authority to mark suspected shipments in order to prevent their entry into another port;

    The details in which Republican devils (a tautology if there ever was one) may lurk involve the requirement that pharmacies, wholesalers and others in the distribution channel must maintain a pedigree of a shipment’s s immediately prior source and subsequent recipient. Shipments from Canada would need to identify all previous entities in the supply chain. The import system would establish a user fee for all participating businesses, the money presumably enabling the FDA to discharge these oversight responsibilities.In principle the facility approval and tracking provisions appear desirable as measures for controlling the drug counterfeiting that occurs even today in the U.S.’ loosely monitored landscape of mom-and-pop wholesalers. It remains an open question, however, whether a Bush-influenced FDA that orders its top reviewer not to comment about a drugs hazards at an advisory committee hearing can capriciously seize upon ambiguous situations to logjam the entire process.

UPDATE: Gregg was reported to be introducing the bill by the Washington Post this morning

POLICY: The war on pain doctors

Like Robert Centor at MedRants, Chris Rangel MD and many, many others I’m a strong opponent of the War on Drugs, but I rarely bring that up in THCB. That’s because the Drug War is largely a political, social and criminal justice issue rather than a health care issue. However, in one arena, the War on Drugs–as prosecuted both by Ashcroft’s justice department and many Republican and Democrat state and local attorneys-general is not only completely out of control, but is a direct assault on health care provision.

I’m referring of course to the draconian prosecutions of physicians who treat chronic pain by prescribing opiates. Given my other recent posts on access to rural healthcare in California, the case of Dr. Frank Fisher is very relevant. Fisher is a Harvard trained doc, who until 1999 was running a general health center for the poorer residents of Shasta county–a very rural area in far northern California–including pain management. Some time around 1996 the California and Federal authorities decided to come after him because a few people had died with only the vaguest connections to his prescribing of opiates. One had been in a car crash where he was the passenger. The charges faced by Fisher? Murder!

Last week, five years later, Fisher was cleared at trial of the only remaining criminal charge. That charge was of defrauding Medi-Cal of, wait for it, $150! (I know THCB has been critical of non-prosecution of fraud in the Medi-Cal system, but that wasn’t what we meant!). So now Fisher has to get the state medical board to give him his license back in order to go back to work. Given the history of outright lying and corrupt behavior by prosecutors in this case, that ought to be simple. Whether any of those individuals will be held accountable is less likely.

Meanwhile, what do you think happened to the patients at his clinic, which was destroyed by this action? Go read the full interview with Fisher at DRCNet, but this is an extract about what happened to the people he was serving. As you might have guessed their transition from his care to that of others in that rural underserved area was not exactly smooth:

    You ran a large clinic serving a predominantly poor and rural clientele. What happened to your patients after your practice was shut down?

    Fisher: The impact on the patients has been devastating, it’s been an unmitigated disaster. Their health has deteriorated, they’ve been unable to get medical care, some appear to have aged 20 years in five years, others haven’t even survived. Some patients have gained enormous amounts of weight, others have their blood pressure out of control. I suspect there has been at least one suicide. Patients are having to travel great distances to get their care; they go to Eugene or Fresno or San Francisco. Of the patients I still talk to, I don’t think a single one is being adequately treated.

    Chronicle: The majority of your patients were Medi-Cal patients, poor people. Is there a class issue involved in the availability of pain treatment?

    Fisher: The availability of pain management for poor people is even worse than for the rest of us. And it’s not good for the rest of us. Everyone who develops chronic pain is likely to be killed by it because of medical neglect. It’s a malignancy in the sense that if it is not controlled, it will spread and progress. My patients were effectively tossed out on the street to fend for themselves. The local medical clinic saw them as drug addicts who needed to be detoxed.

POLICY: A rural California MD comments on the CHCF studies

Leonard Soloniuk, MD, wrote in to THCB to comment on my post on Frday linking the care for Medicaid and uninsured patients in California with the Canadian experience. A post in which I was a little shrill about certain American and Canadian critics of the Canadian system. He has an interesting perspective on the type of problems the CHCF reports were describing.

    I’m always surprised by the continued criticism that the Canadian health care system gets for lack of access when I see equally serious problems in the US.

    My perspective: I am a specialist in a rural, mostly indigent county in Far Northern California. Medi-Cal patients can get primary care easily enough (wait list for a new patient is about 2 months) because the county clinic is heavily subsidized by the Feds and the state (the clinic gets about $75 per patient visit, while I get about $18 per Medi-Cal patient visit). Because of the disconnect between cognitive and procedural reimbursement (a whole different subject), there is usually not much of a problem getting surgery for Medi-Cal patients. Medi-Cal actually pays better than private insurance for many surgeries. However, there are still significant waits for certain specialities: 12 months for Urology, 6-12 months for Neurosurgery, for example. For non-procedural specialities, there are significant delays, such as 12 months for Rheumatology.

    These waits sound just as bad as the Canadian system, but I just don’t see them mentioned in articles comparing the two systems.

    Of course, the uninsured can face significant barriers to care. The barriers are so discouraging that it is my office policy not to see uninsured patients (I policy that I violate only once a week or so). I don’t see them because I can’t provide good care for them. I can’t order lab work, xrays, scans. Interestingly, the lowest barrier for the uninsured patient is for medications. Between samples and pharmaceutical programs for indigents, I can almost always get meds for the patients.

    Thinking about this issue some more, I think that the speciality with the worst problems for access to care is psychiatry. Access to mental health care is difficult even for insured patients, because of higher co-pays, etc. For the indigent, the resources are awful. “It really sucks to be mentally ill and poor in America.”

    I’ve never seen any comparison about access to mental health care in Canada or England. Any comments?

MEMORIAL DAY OFF

I’ll be taking Memorial Day off. If you are in DC for the holiday I highly reccomend the exhibit of WWII photos in Union station, where I passed a very pleasant hour wating for a train. Best wishes to all veterans of all wars (on all sides). Given that I just visited Turkey, I thought these words of Turkish leader Ataturk (who led the Turkish army at Gallipoli), written to a group of Australian parents visiting Gallipoli in 1934, are very appropriate:

    Those heroes that shed their blood and lost their lives; You are now lying in the soil of a friendly country.Therefore rest in peace. There is no difference between the Johnnies and the Mehmets to us where they lie side by side here in this country of ours. You, the mothers, who sent their sons from far away countries, wipe away your tears;your sons are now lying in our bosom and are in peace. After having lost their lives on this land they have become our sons as well.

POLICY: It sucks to be sick and poor in America

While some of my fellow bloggers have seized on the opportunity afforded by the Canadian election to criticize the alleged "monstrosity" of the Canadian health care system, the true "stinking" is emanating from the system for care of the poor here at home. CHCF is out with two new studies which, while not exactly new news, confirm that access to care for uninsured Californians is terrible, access for those on Medi-Cal is not much better, and that those who receive their care at Federally Qualified Health Centers have enormous problems getting to specialist care.

I won’t dwell on this here and you can go read the reports, but suffice it to say that the Fraser Institute’s analysis of what’s wrong with Canada continually omits to tell the truth about the relative difference between the systems. THCB analyzed the actual situation (rather than some Libertarian fantasy) in the "Oh Canada" post last year. The story from exhaustive studies is that all Canadians have to accept some limitations on getting to highly expensive care, but that has no discernable effect on their overall health or real access to necessary care, and no Canadians have real financial problems associated with getting that care. On this side of the border, well insured Americans have more or less immediate access to expensive care, but poorer and even lower-middle class Americans have much worse access than wealthier Americans (as borne out by the recent CHCF studies) and also than poor Canadians. And up to 25% of Americans have significant financial trouble due to health care expenses. If that means that the Canadian system is morally inferior to ours, let me just say that I have a hard time grokking the morality of those who think so.

QUALITY: Pay for Performance, Care Management and the scribblings of defunct economists

Back in 1997 when IFTF was working on the 10 Year Forecast of Health and Healthcare, our chief economist Greg Schmidt vehemently decried capitation and FFS as unsustainable systems and said that a rational market would develop in paying for medical excellence. He convinced us all to put something called "Performance-based reimbursement" in our forecast, and our final forecast suggested that by 2010 some 20% of reimbursement for the health care system would be in some kind of pay for performance manner. Remember what Keynes said about us all being "slaves of some defunct economist"?

This week two different sets of leading health care luminaries have put the state of Pay for Performance and its related cousin of plan-based care management in their sights. Brad Strunk and Robert Hurley at HSC have an issue brief looking at the spread of "P4P" in several of the markets that HSC tracks. Their analysis is that P4P is plan driven and a response to try to tease out some of the "good effects" of capitation. (You remember the pre-Helen Hunt period when capitation was supposed to encourage long-term thinking in care management, and innovation in improving patient services?) It’s obviously also a way for plans to try to establish some limited control over provider behavior during a period when visions of a return to 1973 and the "Golden Age" have been terrifying the plan medical directors trained at the temples of the prophets Enthoven and Berwick.

Berkeley’s Jamie Robinson (the other Reggie Herzlinger fan) and CHCF’s Jill Matthews Yegian have an online piece in Health Affairs which summarizes the plans dilemma nicely:

    "Health insurers are under conflicting pressures to improve the quality and moderate the costs of health care yet to refrain from interfering with decision making by physicians and patients"

. That’s really what health plans efforts to create better care for their members have evolved into.

Their article is an accurate parsing of the state of the art of DSM as managed by major health plans (or more accurately their data jockey and care management subsidiaries). They parse care management it into Identification (either data based, self-assessed by patients or more likely gained via notification from physicians that something bad is happening) and Intervention. Intervention tends to happen well when a nurse gets the patient on the phone (the American Healthways or Lifemasters model) and not so well when a medical director is trying to change physician behavior one doc at a time (the initial Active Health Management model).

Robinson and Yegian basically call the state of medical management out as being nothing more than a minor attempt to keep some level of quality improvement in the system while not upsetting providers or patients very much. They also doubt that there is much bang for the buck in these programs beyond a narrow segment:

    "The health plans’ medical management programs are designed, packaged, and priced with modest expectations for what they can deliver. All programs assert that they generate a positive return on investment, with the benefits in lower medical costs exceeding the administrative costs of identification and intervention. The positive return on investment is predicated on the modest level of investment, however, and a major ramping up of medical management programs would not generate commensurately higher returns and slay the dragon of cost inflation and quality deficiency."

In other words they seem to think that Wennberg and the Dartmouth crowd’s jobs are safe for now.

In a follow-up piece Victor Villagra notes that as health plans have developed DSM outside of the "traditional" provider system, no one has dealt with the complex question–"Can DM Organizations Support Small-Practice Adoption Of The Chronic Care Model?" It’s not hard to see Robinson and Yegian’s answer as being "No".

I’m not quite so certain. Somewhere in the bowels of the malpractice debacle a reasonable debate about following evidence-based medicine is trying to get out. If you think about it care management is all about extending evidence-based medicine over the continuum of care. P4P is merely about trying to encourage that trend. While the defeat of managed care in the court of public opinion and in the boardrooms of insurers seems more or less final for now, there are two things leading me to believe that the war is not yet over. First, it’s just the right thing to do, and you know what Churchill said about Americans doing the right thing. Secondly, and rather more known to motivate Americans, it’s the money. If aggressive private sector negotiating doesn’t work to restrain health care costs, something else will find its place. Stein’s law says that if something’s unsustainable in the long run it will end. At some point 15-20% rises in health care costs every year is unsustainable. The combination of EBM, care management and P4P has the kernel of a promise to reduce the care variation, the unnecessary care and the dumb care that is responsible for a big chunk of the $1.6bn spent every year.

So round one to the system, but I for one still believe that the question of Greg Schmidt’s "defunctness" is still up in the air.

The IFTF Forecast from 1998

PHARMA: Formularies–penny-wise, pound foolish.

You may notice some slightly funky publishing schedules this week as I’m on the east coast confirming that Boston is cold in May, that the Big Dig is never-ending, and that Amtrak can make the trains run on time. Meanwhile in the better late than never category I wanted to make sure that THCB readers didn’t miss (and of course you saw it elsewhere) the RAND report about pharmaceutical formularies and their impact on Rx consumption. In yet more proof that in my earlier life I hung around with intellectuals way above my station, this study was led by Dana Goldman, who was a mere Econ grad student when I was at Stanford, but has certainly moved on since then! (He’s now head of Health Economics at RAND).

Goldman’s team linked a huge dataset of Rx claims with pharmacy benefit design for over half a million lives from a wide variety of plans and employers. (Incidentally the brain and data crunching required for this study–given that these things are not usually correlated in that way–must have been immense and makes me glad that I didn’t try to emulate his success!). The results mirror a study in the NEJM last year, which looked at 3-tier formularies. The bottom line in both studies is that if you increase the co-payment at point of dispensing, people take fewer drugs. RAND found that a doubling of the co-pay caused up to a 45% decrease in use of NSAIDs and antihistamines–presumably because cheaper OTC products were substituted. That’s a win for the payer and probably not too much of a loss for the consumer. But at that point things get a little less clear. “Reductions in overall days supplied of antihyperlipidemics (34%), antiulcerants (33%), antiasthmatics (32%), antihypertensives (26%), antidepressants (26%), and antidiabetics (25%) were also observed.” And even more disturbingly “patients with diabetes reduced their use of anti-diabetes drugs by 23%.”.

Presumably having one in four diabetics reducing their maintenance drug use isn’t the type of health promotion that all the PBMs’ marketing materials claim they are aiming for. And of course as Harvard’s Steve Soumerai showed years ago in looking at restrictions on schizophrenia drugs in Medicaid, a modest saving in one place often causes a much bigger loss in another. Although it’s not in the abstract, the Modern Physician story about the report quotes author Geoffrey Joyce:

    While the drop in usage is not nearly so high with drugs for chronic conditions, “we find significant price sensitivity in this population,” Joyce said. “We think there are adverse health consequences.” For patients with diabetes, asthma and gastric acid diseases, emergency room visits climbed 17% and hospital stays rose 10% as the use of prescription drugs dropped, according to the research.

    What to do is a question of balance when creating a formulary, according to Joyce, who warned against using increase in copays as a “blunt tool.” “I think there is this herd mentality to control drug costs without fully considering their overall healthcare costs,” Joyce said. “You can design it to make people price-sensitive without creating adverse consequences.”

Now bear in mind that not only are the health consequences of these serious, but the DCCT study over a decade ago proved that a combination of testing and drug use could maintain diabetics in a stable state, whereas poor compliance increased both the incidence of hospital visits and overall costs for the diabetic population. It seems that those lessons haven’t been learnt. Of course having a drug budget separated out from the overall health budget doesn’t easily allow a payer to make that connection. Consequently you have to be concerned about the way that Medicare is administratively separating off its drug coverage from its overall care system.

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