Medicare reform bill.

The Kaiser Family Foundation picked up a report (requires paid subscription) from today's Wall Street Journal that Sen. Grassley (Republican chair of the Senate Finance Committee) has pulled his staff out of the conference committee negotiations over the House and Senate Medicare reform bills. His complaint: not enough time is being devoted to rural health issues. Earlier reports on the process indicated that this promises to be the largest package of Medicare amendments since its inception in 1965, but Grassley's on-again-off-again relationship with Ways and Means Committee chair Bill Thomas highlights one of many schisms on the Republican side.

Dallas Morning News blogatorial page.

Congrats and a high-five to the editorial board of the Dallas Morning News for letting it all hang out on their new DMN daily, a blog-like page on their web site. Now, if only there were an RSS feed . . . .

Conjoined twins.

Two brothers from Egypt who are joined at the tops of the their heads (a condition known as "craniopagus") are scheduled to be separated in a 2-day procedure at Children's Medical Center of Dallas later this fall. The medical, human, and ethical issues are explored sensitively and well in a special-section insert written by medical reporter Laura Beil in today's Dallas Morning News.

Health care industry's federal fines at record pace.

According to a Wall Street Journal article reprinted in today's St. Lous Post-Dispatch, "[i]n the last three fiscal years, the government has amassed $4.21 billion in fines, settlements and restitution payments from its health-care probes, well more than the $3.29 billion it collected in the previous 10 years combined":

This year, the federal government is poised to collect more than $2 billion in payments from HCA Inc., Abbott Laboratories, AstraZeneca PLC, Bayer AG, Guidant Corp., GlaxoSmithKline PLC, Tenet Healthcare Corp. and Pfizer Inc.

More settlements are expected. Schering-Plough Corp. anticipates more than $150 million in liability from investigations by U.S. attorneys in Boston and Philadelphia into alleged marketing violations. Fred Hassan, who took over as Schering-Plough's chief executive in April, has said that he's holding "constructive dialogue" with the prosecutors and that he's ready to settle the issue.

This would be a good time to invest in a law firm with a good white-collar and complex civil practice . . . .

Medicare HMOs under the spotlight in South Florida.

South Florida, one of the last places where managed care organizations can make a pretty healthy profit in the Medicare+Choice program, and where competition for enrollees is intense, is also where CMS is watching marketing campaigns and the beahvior of HMO execs very closely. In an article in today's Miami Herald, it's reported that Medicare -- which dinged CarePlus for its marketing practices -- has now sent a letter of reprimand to CarePlus' CEO for incomplete and potentially misleading comments made last month to the Miami Herald in connection with a story about the Medicare fine. The marketing abuses included a claim that CarePlus offered unlimited pharmacy benefits (they should have said "unlimited generic pharmacy benefits") and their failure to state "that disabled Medicare beneficiaries, not just seniors could enroll in the Medicare+Choice HMOs."

Non-heartbeating [organ] donors.

Canada is now engaged in a very healthy debate over whether to initiate protocols to harvest organs from non-heartbeating donors (NHBD), according to a story in Thursday's Ottawa Citizen. The concept involves a return to the days before "brain death" criteria had been developed, at least in those cases in which waiting for brain death may result in the degradation of the viability of the transplantable organs. The protocol, some version of which is in place in many transplant centers around the U.S., involves disconnecting a patient from life support, waiting for a nominal period of pulseness and apnea, declaring death according to traditional cardiopulmonary criteria, and then harvesting the organs. The ethical questions have to do with two features of the protocol: (1) A drug (phentolamine, e.g.) is administered to dilate blood vessels and maximize blood flow and oxygenation, but dilation may lower blood pressure, perhaps catastrophically, raising the question whether death is being induced by the regitine. If the regitine is causing death, is the procedure homicide? (2) How long should surgeons wait after the termination of life support before declaring (to borrow a widely adopted state-law standard for declaring death) that circulatory and pulmonary functions have irreversibly stopped? The longer the surgeons wait, the more damage is done to the organs. An article in the current issue of the Canadian Medical Association Journal argues that the protocol could increase the supply of transplantable organs dramatically. But, as the redoubtable Margaret Sommerville stated in the news article, "I know the pressure to get organs for donation. . . . But we must be very careful that we're not fudging the criteria of death for the purposes of organ transplantation. . . . If they're suggesting nearly dead is as good as dead then there's a big problem in it. . . . The Criminal Code says any shortening of life, no matter how small, is murder." In this day and age of passive euthanasia, terminal sedation, and physician-assisted suicide, the lines are getting blurrier all the time. This is one opportunity for some needed clarity.

Medicare prescription drug benefit.

As noted repeatedly in this space, Congress is currently fighting over the details of a projected $400-billion-Medicare-prescription-drug-benefit-that-we-can't-really-afford. In an editorial today, the Christian Science Monitor appears to say they wouldn't mind seeing the benefit enacted if only Congress would get around to trimming the budget in some eminently trimmable ways (as recently reported by the Government Accounting Office). It's a thought, ain't it?

Medicare to Pay for Major Lung Operation.

The Medicare program has approved a controversial procedure (discussed here earlier this week) that offers significant relief from symptoms for many emphysema sufferers, though at a very high price (~ $60,000 per procedure). The CMS press release on their coverage decision for lung volume reduction surgery is here.

International notes from all over.

France. In addition to Germany, whose health care reform plans were mentioned here last month, France's Jacques Chirac has acknowledged that his country's death toll from Europe's current heat wave -- which France's government minister for the elderly estimates will reach 10,000 -- will prompt a government review of the health system's "insufficiencies."

Canada. As reported in the Toronto Globe and Mail this morning, Steffi Woolhandler et al. have an article in today's New England Journal of Medicine that says the U.S. health system's overhead expenses $450 billion per year, triple that of Canada, and the gap appears to be growing. They attribute our overhead to the costs of maintaining a fractured private system of health care finance and delivery. After calculating each country's expenditures to a common currency and recalculating the difference based upon per capita expenditures, the real difference is said to be $209 billion. (See abstract here; full text requires subscription) Even if Henry Aaron of Brookings is correct (extract) that Woolhandler's group has overestimated our overhead expenses by $50 billion, the difference is striking. More fundamentally, however, he questions whether the exercise is a significant one for purposes of developing health care policy. A comparison of dollars spent on administrative expenses, or any other category of health care spending, ignores something fundamental about the health care system of any country, including ours:

"More fundamentally, the administrative structure of any nation’s health care system, and certainly those of Canada and the United States, evolves out of its political history and institutions. The U.S. health care administration, weird though it may be, exists for fundamental reasons, including a pervasive popular distrust of centralized authority, a federalist governmental structure, insistence on individual choice (even when, as it appears to me, choice sometimes yields no demonstrable benefit), the continuing and unabated power of large economic interests, and the virtual impossibility (during normal times in a democracy whose Constitution potentiates the power of dissenting minorities) of radically restructuring the nation’s largest industry — an industry as big as the entire economy of France. For these reasons, careful scrutiny of how the United States administers its health care system, with an eye to how it can be improved within the limits imposed by history, politics, and economics, is useful. But analytically flawed comparisons with other nations, whose systems differ greatly from our own and that we are most unlikely to emulate, may titillate policymakers and others but provide them with little useful guidance."

The same issue of NEJM has a piece by Detsky & Naylor entitled, "Canada's Health Care System -- Reform Delayed" (extract). It is a useful political and social history of Canada's national Medicare system, often held up by health-reform advocates as a model worth emulating by the U.S. Taking a page from Henry Aaron, a reader would be wise not to try to draw explicit policy conclusions for the United States from Canada's experience. For example, the constitutional structure of Canada's system

"puts the authority for taxation largely in the federal sphere but the management of health care systems under provincial jurisdiction. The inevitable byproduct of this division of powers is recurrent squabbling among levels of government about health care. Because the federal government has very limited powers to promulgate legislation or regulations that control provincial health services, it can lead only by persuading the provinces to accept conditions on funds that it transfers to them. If the provinces fail to comply with the conditions set by the federal government, the only recourse is to impose financial penalties by withholding portions of the transfer payments. Most provinces, in turn, have resisted the imposition of conditions on federal transfers, and the resulting negotiations among provinces and with the federal government are usually intense. As a result, Canada’s health care system is best described as a collection of plans administered by the 10 provinces and 3 territories, each differing from the others in some respects but similarly structured to meet the federal conditions for funding. The simplicity of the five federal conditions is arguably one of the beauties of the Canadian system. They are the provision of all medically necessary services (defined as most physician and hospital services), the public administration of the system, the portability of coverage throughout Canada, the universal coverage of all citizens and residents, and the absence of user charges at the point of care for core medical and hospital services."

Detsky & Naylor also point out that

"[t]he system is unique in the world in that it bans coverage of these core services by private insurance companies, allowing supplemental insurance only for perquisites such as private hospital rooms. This ban constrains the emergence of a parallel private medical or hospital sector and puts pressure on the provinces to meet the expectations of middle-class
Canadians."

Interestingly, CanadaEast.com reports today that the Canadian Medical Association has joined a case before the Canadian Supreme Court challenging Medicare's government monopoly. CMA says it isn't advocating the creation of a private-care option, which is being advocated by others in the suit, but instead wants stirct guidelines to limit the long waits Canadian patients sometimes have to endure before getting care covered by Medicare. The alternative that CMA wants is a right to go outside the province or even outside the country (guess where?) at home-province expense once the maximum waiting period has been exceeded. Stay tuned . . . .

Pediatric drug testing.

This is a good Associated Press article that reports the unsurprising news that the FDA believes pediatric drug testing has made drugs safer for children (according to an article published in today's JAMA) (abstract only; full text requires subscription). What makes this newsworthy is the checkered history of such testing, from being almost nonexistent to being required by the FDA for many drugs to being declared beyond the FDA's statutory authority to being authorized by Congress last year.

Organ transplant shortage.

This is the public-health version of the saying "no good deed goes unpunished." Fewer young people's organs are available for transplant over the past decade or so, a trend that is fueled in part by a salutary trend: a decrease in the number of young people who die from trauma, according to a story in today's New York Times (no permanent link available at this time). In a related story, Randi Hutter Epstein reports on the diplomacy required to persuade parents to donate their child's organs for transplant.

JCAHO.

It's a rare day when JCAHO revokes a fully accredited hospital's accreditation. I have found only one so far, but I've only checked the larger states on the JCAHO "Quality Check" page, where you can find the accreditation status and accreditation history of various health care organizations. Modern Healthcare's "Daily Dose" reports that Greater Southeast Community Hospital in Washington, D.C., has lost its appeal of JCAHO's June revocation decision, but GSCH was never more than conditionally accredited.

Patient Privacy Rules Bring Wide Confusion.

HIPAAmen.

Antitrust claims of medical residents.

I've always thought that the medical residents' antitrust challenge to the National Resident Matching Program -- in which hospitals and graduates alike agree not to compete for positions but to accept the computer-generated pairings -- had considerable merit. Here's one analyst's take on the plaintiffs' theory:

"The antitrust lawsuit against the ACGME claims that the Match is anticompetitive because it eliminates the influence of free markets on salaries. Although the Match does not technically fix prices, it prohibits residency programs from making offers outside of the Match. This rule wipes out the market for medical residents and undermines price competition, because it prevents students from negotiating with the different hospitals. Without an offer in hand, students have no power to negotiate with the programs, and programs do not need to compete for residents through salary or other monetary benefits. Programs are also deterred from increasing salaries to compete for students, because they cannot be guaranteed that the students whom they really want (and whom they believe are worth a higher price) will be matched with them. Therefore, programs have, in effect, set a flat salary of roughly $40,000 for all members of house staff throughout the country, irrespective of the specific demand for their labor." (Sanders Chae, "Is the Match Legal?", 348 N. Eng. J. Med. 352 (2003) (extract; full text requires subscription))

At the same time, it is difficult to imagine the staffing chaos -- and the impact on the availability of much needed health care services -- that would be produced by a market-driven, frankly competitive system in which no one knows where all the residents will be working until June 30. Apparently the defendants think there might be some merit in those claims, as well. Of course, inconvenience and higher costs are not defenses to an antitrust suit, but they find support in various courts' analyses of the "procompetitive effects" of otherwise anticompetitive behaviors and can provide reasons to take the defenses very seriously. Here's the same analyst's view of the "procompetitive" defense:

"Specifically, the Match appears to increase the choice of residency programs for medical students by allowing them to interview at multiple programs. It also prevents insiderism and thus might enhance diversity."

According to an article by Neil Lewis in today's New York Times, they are trolling the halls of Congress looking for legislative protection from potentially devastating monetary damages. (A spokesman for the Association of American Medical Colleges, one of the defendants, denies any such implication and insists that the legislation is being sought precisely because they believe the suit has no merit.) In addition to generating fees for lobbyists and defense attorneys, the antitrust suit appears to have had another impact as well. The governing board of the Match voted at their May meeting to delay implementation of a new policy that would require all participating institutions to register all of their positions with the Match ("only" about 80% are currently listed), a policy that could have the effect of compounding the antitrust injury -- if any -- currently produced by the Match. There is a nonfrivolous argument that the Match does not produce antitrust injury, as explained by the same NEJM analyst:

"Antitrust claims under Section 1 must show that the restrictive practice has anticompetitive consequences, such as an inefficient transfer of wealth due to higher prices, a reduction in output, or a diminished quality of goods or services.4,5 It is not obvious that teaching hospitals are underpaying residents in order to transfer wealth from resident to hospital as excess revenue or profit. However, there may be a transfer of wealth when residents care for the private patients of attending physicians who do not participate substantially in resident training. It is also hard to believe that the Match reduces output by decreasing the amount of health care that teaching hospitals provide. Indeed, low salaries might increase output by enabling teaching hospitals to hire more residents, leading to more health care. A final difficulty is that Medicare pays salaries through a fixed sum paid to the hospitals. If Medicare would not provide higher salaries in a freemarket system, the Match might not be responsible for low salaries."

If you're interested in Dr. Chae's full analysis, address reprint requests to Dr. Chae at the Department of Medicine, Columbia University College of Physicians and Surgeons, 622 W. 168th St., New York, NY 10032, or at sanderschae@post.harvard.edu.

Rationing health care.

Two articles in today's New York Times raise provocative questions of health-care rationing and justice. One story is about Zell Kravinsky, a multimillionaire (well, he was a multimillionaire before he gave away $45 million to various foundations) who more recently donated one of his kidneys to a complete stranger. His wife has threatened to divorce him if Zell doesn't tone down his altruistic tendencies, and even his mother disapproves: "You can give money, you can give service. Body parts are quite another thing." Zell's explanation is strictly a utilitarian one: "No one should have a vacation home until everyone has a place to live . . . . No one should have a second car until everyone has one. And no one should have two kidneys until everyone has one."

In the second article, "New Therapies Pose Quandary for Medicare," Gina Kolata discusses medical therapies that could benefit tens of thousands of Medicare beneficiaries but at a cost of (as the late Carl Sagan would have said, in a different context) "billions and billions," indeed at a price that would dwarf the projected price tag for the prescription drug benefit currently being debated in conference by Congress. As Kolata puts it: "The federal Medicare program is expected to decide this week whether to pay for an aggressive and expensive lung operation that could offer a lifeline to tens of thousands of elderly patients. But health economists and medical experts say the treatment, however alluring, is part of an unsettling trend: new and ever pricier treatments for common medical conditions that are part and parcel of aging — procedures that could potentially benefit tens of thousands of patients, at a total cost that would far exceed the kind of prescription drug benefit now being considered by Congress. The questions, these experts say, are how much Medicare can or should pay, and whether cost-effectiveness should enter into the decisions." The chief medical officer for the Centers for Medicare and Medicaid Services, which administers the Medicare program, is quoted as saying "he understood that the costs of new technologies can be staggering. But he adds that cost has traditionally not been a consideration in deciding what to cover. 'If the technology was effective, we would find a way to pay for it,' he said. 'There is no dollar value per life per year at which Medicare would decline to pay.' But," adds Kolata, "costs are mounting."

Cryonics.

So: Alcor, the cryonics firm that has Ted Williams' body frozen in Scottsdale, now admits that they mistakenly decapitate the Splendid Splinter despite his family's expressed wishes to keep him in one piece. (See story) And Alcor's ex-COO posted pictures of Williams' head on the Web. And this COO is ready to testify as to all sorts of shoddy practices concerning the handling of DNA (including Williams'), human remains, and body parts. Meanwhile, a Boca Raton firm, Suspended Animation, has applied for the necessary permits to become Florida's first cryonics facility for humans. (See story) As reported by Popular Mechanics, the technical problems of freezing and thawing something the size and density of a human body are mind-boggling. This raises the question whether it is unethical to sell this service at this time, even with appropriate informed-consent disclosures, or should the regulators just let the suckers continue to be gyped.

Single-payer national health insurance redux.

As noted here on Tuesday, the Physicians' Working Group for Single-Payer National Health Insurance published their recommendations for such a plan in this week's JAMA (abstract only; full text requires subscription). Yesterday's Seattle Post-Intelligencer thoughtfully recommended that the debate should begin on the key questions posed by the doctors' group's recommendations ("Doctors diagnose health care woes":

"[JAMA editorialized that] 'American health care system and the American society face a real problem and are compelled to search for an answer.' . . . In the way of such an answer lie many questions. If we were to tax ourselves to provide a certain level of health care for everyone, what would that level be? How would that be decided and by whom? Who pays for what's not covered and how? Much disease is preventable through proper nutrition and behavior, while a huge portion of health care costs are incurred in the last months of life. Would public funding of health care necessitate a public policy debate on how the funding is allocated? Could an American national health plan be designed to offer the benefits of other nations' programs without the shortcomings? . . . The physicians have opened what should be a healthy -- and long overdue -- debate on an issue that literally touches everyone's life."

How much better a response to the doctors than the knee-jerk opposition of the AMA itself (as opposed to its mostly and almost always editorially independent journal, JAMA) and editorialists such as Jerry Heaster of the Kansas City Star. Heaster writes in today's paper that the announced decrease in physician reimbursements from the Medicare program next year, against the backdrop of Congressional debate over a $400-billion-Medicare-drug-benefit-we-really-can't-afford, highlights the ineptitude of the government when it comes to running really big, complex programs. He ends on a sourly populist note: "There are three ways to do things: the right way, the wrong way and the government way. This is a good example of the government way."

Okay, fine, Congress is blowing it big-time with this budget-busting drug benefit, and they have shown contempt, if not bad faith, in their dealings with physicians in recent years (and even going back some years before that, truth be told). But how much can we know about the operation of a national single-payer system from the history of a government program that is engrafted upon a market-based system? How, in other words, can Medicare possibly get out of the budgetary hole and regulatory morass it is in when it has to coordinate the functioning and financing of its benefits with an otherwise investment-driven and employer-dominated system? Maybe it will turn out that in the long run a single-payer system is a pig in poke and shouldn't be attempted. But we won't know unless there is honest debate on the kinds of important questions identified by the Seattle PI's editorial board, rather than chest-beating and snidely anti-government sloganeering.

More on stem cell research and cloning.

In addition to the three-fer in the Mayo Clinic Proceedings mentioned here yesterday, the New England Journal of Medicine had its own three-fer on this topic in its July 17 issue. The NEJM offers full text articles, with rare exceptions, for subscribers only, so all I can give you here are links to the abstracts, which are available to the public for free.

Prometheus's Vulture and the Stem-Cell Promise, by Nadia Rosenthal, Ph.D.

Review Article: Nuclear Transplantation, Embryonic Stem Cells, and the Potential for Cell Therapy, by Konrad Hochedlinger, Ph.D., and Rudolf Jaenisch, M.D.

Edtorial: Legislative Myopia on Stem Cells, by Jeffrey M. Drazen, M.D.

Boutique medicine.

According to a story in the Aug. 11 Boston Globe, Tufts-New England Medical Center will open a "concierge" or "boutique" primary care practice for patients who have the $1,800 to pay annually for access to longer appointments and quieter waiting rooms. The hospital system says the extra income will help subsidize the primary care it offers to all patients regardless of ability to pay and help stem operational losses that totaled over $12 million last year. As noted here on August 5, Washington's Commissioner of Insurance recently ruled such arrangements illegal. The Globe reports: "Blue Cross & Blue Shield of Massachusetts, Tufts Health Plan, and Medicare, the federal insurance program for the elderly, currently contract with concierge practices, but they are wary."

Not-for-profit conversion gone wild.

A report in today's Baltimore Sun says that federal investigators have subpoenaed records of CareFirst BlueCross/BlueShield in connection with the aborted attempt by Maryland's largest health insurer and its officers to convert the company to a for-profit corporation and sell itself to WellPointHealth Networks in California. The 15-page subpoena is directed at CareFirst, the Maryland Insurance Administration, and the law firm that represented CareFirst and its CEO. The federal probe follows upon the heels of a 352-page report by Maryland Insurance Administration Commissioner Steven B. Larsen in March, which accused the CEO and others officers of CareFirst of deception, conflicts of interest, mismanagement and flagrant attempts to profit personally from the proposed sale.