Concierge medicine now supported by trade association.

As reported in today's "Daily Dose" from Modern Healthcare,

A new national organization has been formed to serve as an advocate and information clearinghouse for practitioners of concierge medicine -- a controversial model of patient care that usually requires patients to pay an annual membership fee for such perquisites as customized-care plans and round-the-clock access to doctors. Officials with the not-for-profit American Society of Concierge Physicians said doctors in about two dozen states now offer some form of concierge service but remain a small fraction of all practicing physicians. An ASCP spokeswoman said the group has 26 members, representing "10% to 20%" of doctors involved in concierge services. John Blanchard, president and co-founder of the group and founder of Premier Private Physicians in Detroit, said he expects the number of physicians involved in concierge services to grow dramatically in the next several years because the model "allows (doctors) to practice medicine the way it was intended to be practiced -- with the patient as the focus." The organization has scheduled its first annual conference for May 27 and 28 in Denver, where about 20 practitioners from across the country will discuss ethical, legal, regulatory and social issues surrounding retainer-based practices.

Membership in the ASCP requires payment of a $500 fee; the application form doesn't say whether this is an annual or one-time fee.

For the time being, CMS is taking no position as to whether retainers paid to physicians to secure preferential treatment constitute "balance billing" or "private contracts" under Medicare law. A plausible argument could be made either way, but if CMS were to take the position that the retainers were either one, that would be a serious blow to the concierge-medicine movement. "Balance billing" is limited to 109.25% of the Medicare approved amount for covered services; presumably concierge retainers are significantly in excess of that amount. "Private contracting" is permitted under the Medicare law, but it requires that the physician agree not to bill Medicare for any covered services for any Medicare beneficiaries (not just the one with whom the private contracted is entered into) for a period of three years. There are some specialties that can afford to take the hit (i.e., those with relatively few Medicare beneficiaries and those with a high percentage of services that are not covered by Medicare), but many can not. A Feb. 2004 publication (Physician's News Digest) does a nice job of reviewing the developments from the AMA (so far, the practice is deemed to be not inconsistent with their ethics opinions, which are supportive of diversity and innovation in the delivery of physicians' services, as long as certain guidelines (adopted by the Council on Ethical and Judicial Affairs at its June 2003 meeting) are adhered to).

The most sustained criticism of concierge medicine is from Troy Brennan (faculty member at Harvard's Medical School, School of Public Health, and Law School ("Luxury Primary Care -- Market Innovation or Threat to Access?" N. Eng. J. Med. 2002;346:1165-1168) (requires subscription), who identifies a number of ethical concerns with concierge medicine: (1) transitioning from a standard to a concierge practice may result in the abandonment of existing patients or in a diminished quality of care; (2) concierge medicine undermines the cross-subsidization of care for patients with lousy insurance or no health insurance at all; and (3) by allowing physicians to focus on the needs of a relatively small patient population defined by their ability to pay fairly steep retainers, the practice could exacerbate inequities in access to care that already exist. Of course, the flip side, as Brennan concedes, is that the development of concierge medicine may be the crystallizing event that leads organized medicine to examine more seriously than it has to date the myriad ways in which financial inequities limit access to care and to start addressing them in a concerted fashion.

Appellate advocacy at its finest.

For all the 1L's in my Constitutional Law class, preparing their briefs for moot court and anticipating the day they will get up and argue their first (moot) case, here's a keeper from Howard Bashman's "How Appealing" blog:

The perils of an advocate's trying to replicate an allegedly hostile work environment from the lectern at the start of an appellate oral argument: Today in the U.S. Court of Appeals for the Seventh Circuit, a three-judge panel consisting of Circuit Judges Richard D. Cudahy, Richard A. Posner, and Ilana Diamond Rovner [by the way, none of these links appears to be working, but I'm including them from the original post, just in case the problem is only temporary] heard oral argument in the case of Leslie D. McPherson v. City of Waukegan. The attorney for plaintiff-appellant McPherson began his oral argument as follows:

My name is Jed Stone, and I represent the appellant Leslie McPherson.

"What color is your bra? Does it match your panties?"

Immediately thereafter, Judge Rovner interjected:

Are you speaking to Judge Posner?

The courtroom erupted in laughter. You can download the audio of the oral argument via this link (right-click to save MPG audio file to your computer's hard drive before playing audio). Thanks so very much to the reader who emailed to bring this oral argument from earlier today to my attention.

If you listen to the sound clip, check out Mr. Stone's seamless recovery . . .

Other blawgers.

Life being nasty, brutish, and - most importantly for present purposes - short, I rarely get to visit the blawgs listed to the left of this post. But a few minutes at Jack Balkin's blawg yielded two nice pieces that relate to what we are doing in Con Law these days. First, a critique (or, a link to a critique) of the Federal Marriage Amendment's sloppy drafting. Second, a quick hit on the questionable and opportunistic originalism of Justice Scalia.

Anatomy of hope - Jerome Groopman.

I'm working on my own review of Jerome Groopman's new book, The Anatomy of Hope, but meanwhile the N.Y. Times has beaten me to the punch with a review in today's Books section. Groopman, an oncologist at Harvard and the model for ABC's short-lived series, "Gideon's Crossing" (based on his first two books: The Measure of Our Days and Second Opinions), also writes for The New Yorker. His clinical narratives are gems that should be required reading for all medical students and residents. Happily, his New Yorker essays -- which are a nice blend of clinical writing and policy musings -- are collected on his web site.

Running a hospital by the numbers . . . and quality of care.

The Sunday N.Y. Times has an article by Andrea Gabor that describes the turnaround at St. Joseph Health Center in suburban St. Louis. The bottom line is looking better (from losses a few years ago to a modest net revenue of $17 million on $1.8 billion in gross revenues), quality measures are up, and nurse turnover is down. And the key appears to be the dreaded "cookie-cutter" management controls so hated by clinicians. The key seems to be to create a systems approach that focuses on quality and safety, even when it increases costs, because the savings to the hospital are even greater, at least when the investment is focused on achievable advances.

Supreme Court to hear 'dirty bomb' suspect's appeal.

SCOTUS agreed yesterday to review Jose Padilla's case (see CNN's report). The Court's order contains an expedited briefing schedule, presumably to allow it to be argued the same day as the detention case brought by Yaser Hamdi (U.S. No. 03-6696). Other good reviews of the case and the issues it raises are in today's Boston Globe, N.Y. Times, and Washington Post.

This brings to three the number of cases on SCOTUS' docket involving the detention of "enemy combatants" in connection with the prosecution of the war in Afghanistan or pursuant to President Bush's Nov. 13, 2001, Military Order. (Read the order at 66 Fed. Reg. 57833 (Nov. 16, 2001); text version loads faster). Here's the dope on all three cases (docket no., caption, link to ruling below, documents in case (where available)):

• 03-1027 - Rumsfeld v. Padilla [American citizen's challenge to military detention] - 2nd Cir. opinions (majority)(concurring & dissenting)
  
• 03-0334 / 03-0343 - Rasul v. Bush / Al Odah v. U.S. [foreign nationals' challenge to Guantanamo Bay detentions] - D.C. Circuit opinion; case documents


• 03-6696 - Hamdi v. Rumsfeld [military detention in Virginia of presumed American citizen captured in Afghanistan] - 4th Cir. opinion

States looking into screening Canadian pharm imports.

As reported in today's N.Y. Times, Minnesota and Wisconsin will soon ask other states to join them in screening Canadian drug imports. The effort is an attempt to counter safety warnings from the FDA, which has been an implacable foe of importing the lower-cost drugs from our neighbors from the north. Just yesterday, the FDA sent a warning letter to yet another pharmacy (this one is in West Virginia) that allegedly helps its customers obtain drugs from Canadian sources. The FDA's web page re: imported foreign prescription drugs is here. It collects all the agency's regulatory policy statements on the issue, consumer alerts, news summaries, etc.

San Francisco Judge Rules Gay Marriages Can Continue

The NY Times will report on Saturday that "[o]pponents of gay marriage suffered another setback here [San Francisco] on Friday when a judge refused to block the issuance of same-sex marriage licenses, saying the opponents had not shown that the weddings were causing immediate harm." Moreover: "Some judicial experts said that the moves in San Francisco and New Mexico indicated the debate over the licenses was becoming more rooted in legal, not political, ground." For more legal analysis, with an emphasis on the con law aspects of the debate, you could do worse than to start with Larry Lessig's blog on this.

Schiavo update.

After many months and many posts (see here and here, among many others), the Terri Schiavo case is resurfacing. Here's a good editorial from today's Palm Beach Post.

Testing Toxics on Humans Is Ethical, Science Panel Says (washingtonpost.com).

As reported in the Washington Post, a panel of scientists from the National Academy of Sciences issued a report yesterday that says it is ethical to test pesticides and other toxic substances on human subjects to determine whether environmental safety standards can be lowered: "Many scientists and ethicists have argued that such research is never justified, and yesterday's unprecedented verdict by the National Academy of Sciences took environmentalists by surprise."

The ethical analysis is summarized thusly: "While volunteers would derive no benefit and some might incur transient harm, the panel of experts said this would be outweighed by societal benefits. Besides helping regulators set accurate benchmarks for environmental dangers, such trials might also address, for example, how much insecticide can safely be used to fight a malaria outbreak." As politicized and polarized as the debate has been over this kind of testing, the esteemed co-chair of the panel, Jim Childress of the University of Virginia, observed: "While there was no 'foolproof mechanism' to eliminate all risk of patient harm, [the risk for volunteers would generally be] exceedingly low."

What's next? --

Yesterday's decision by a panel of the National Research Council will allow the Environmental Protection Agency to devise a final rule over the next several months, an EPA spokesman said. Both the pesticide industry and environmental groups said they expect the agency will accept the recommendation of the panel, which would also allow the EPA to evaluate human studies of pesticides that had previously been conducted, and give the industry an incentive to conduct new trials.

The panelists called for a rigorous safety and ethics system to evaluate and approve such trials, much like the system used by the Food and Drug Administration to evaluate drug trials conducted by the pharmaceutical industry.

The report allowed for the possibility of trials involving children, but panelists said they could not imagine such tests would ever be conducted. But Erik Olson, senior attorney at the Natural Resources Defense Council, an environmental group, said such tests have already been performed: As recently as 2000, he said, a manufacturer petitioned the EPA to consider data from an Italian study of infants that deliberately exposed them to dichlorvos, an insecticide sold under the brand name Vapona."

The prepublication version of the report can be found on the NAS website. The news release is here.

HHS to AHA: discounting care for the uninsured doesn't violate federal law.

Today HHS Secretary Tommy Thompson released a letter to the president of the American Hospital Association, Richard Davidson, in which Thompson wrote:

[H]ospitals can provide discounts to uninsured and underinsured patients who cannot afford their hospital bills and to Medicare beneficiaries who cannot afford their Medicare cost-sharing obligations. Nothing in the Medicare program rules or regulations prohibit such discounts. In addition, the Office of Inspector General informs me that hospitals have the ability to offer discounts to uninsured and underinsured individuals and cost-sharing waivers to financially needy Medicare beneficiaries.

Thompson went on to write: "To be sure that there will be no further confusion on this matter, at my direction, the Centers for Medicare & Medicaid Services and the Office of Inspector General have prepared summaries of our policy that hospitals can use to assist the uninsured and underinsured." I'm looking for those summaries and will provide a link as soon as they show up on the HHS web site.

Paul Krugman: The Health of Nations

Paul Krugman's op-ed piece in today's N.Y. Times is the first in what I can only hope will be many articles on the Bush administration's political vulnerabilities in the health care arena. Don't get me wrong: the mess we are in is not exactly the Bush administration's doing, not all of it anyway. We've been on a collision course with reality since 1965, some would argue since Teddy Roosevelt's Bull Moose plank in favor of a national, single-payer system was rejected at the beginning of the 20th century. But Bush's economic report has nothing useful to say to the 40 million uninsured or to the many millions of others who are periodically uninsured or chronically underinsured. Speaking of the nature of the problem and the vacuousness of the administration's response, Krugman concludes:

The result is that American health care, which at its best is the best in the world, offers much of the population a worst-of-all-worlds combination of insecurity and high costs. And that combination is getting worse: insurance premiums are rising, and companies are becoming increasingly unwilling to offer insurance to their employees.

What would an answer to the growing health care crisis look like? It would surely involve extending coverage to those now uninsured. To keep costs down, it would crack down both on drug prices and on administrative costs. And it might well cut private insurance companies out of the loop for some, if not all, coverage.

But the administration can't offer such an answer, both because of its ideological blinders and because of its special interest ties. The Economic Report of the President has only negative things to say about efforts to hold down drug prices. It talks at length about insurance reform, but it mainly complains that we rely too much on insurance; it says nothing about either expanding coverage or reducing insurance-company overhead. Its main concrete policy suggestion is a plan for tax-deductible health savings accounts, which would be worth little or nothing to a vast majority of the uninsured.

I'll talk more about alternatives for health care in future columns. But for now, let's just note that this is an issue the public cares about — an issue the administration can't address, but a bold Democrat can.

Placebos - ethical and effective ways of giving them

Accprding to Medical News Today, Howard Brody is lecturing about ethical and effective ways of giving placebos:

"This new way of thinking defines the placebo effect as a special kind of mind-body interaction that occurs in a health-care setting," Brody said.

"Doctors may never prescribe placebos – dummy pills – but can make use of the placebo effect every time they see a patient. Seeing that the 'placebo effect' does not depend on the 'placebo' is key to making use of its healing potential in an ethical way.

"Features of the healing environment usually include a physician or healer that listens carefully to what you say and gives you a realistic and sound explanation of what is happening to you," he said.

"People express care and compassion for your fears and suffering, and you leave feeling more in control of your life and your illness."

In addition, Brody said evidence exists that creating positive feelings in the health care environment goes a long way in treating a patient.

South Korean cloning breakthrough and the Times.

It's pretty obvious the New York Times doesn't want to see any angle on the most recent human-cloning story appear first in a rival paper. In the last couple of days there has been a raft of stories occasioned by the story of South Korean scientists who have cloned a human embryo:

• Denise Grady filed first with a story on early reactions to the Korean story: "Debate Over Cloning in U.S. Remains Intense" (Feb. 12);



• Samuel Len's story profiled the Korean researchers who broke through: "South Korea, With Renowned Scientists, Revives Debate" (Feb. 13);



• Laurie Goodstein and Denise Grady did a story on the debate in this country over cloning-for-reproduction vs. cloning-for-therapy: "Split on Clones: Research vs. Reproduction" (Feb. 13);



• Andrew Pollack has a good story on what remains to be learned before cloning for stem cells will produce therapeutically useful interventions: "Medical and Ethical Issues Cloud Plans to Clone for Therapy" (Feb. 13);



• Gina Kolata does her usual excellent job in today's N.Y. Times on the cloning story: "Despite Advance in Cloning, Scientists Are Tempering Hope With Reality" (Feb. 15);



• Nicholas Wade did a story about the double default cause by the Bush administration's current policy against cloning for therapeutic research (the possibility of a science gap as researchers in other countries leap-frog over hog-tied researchers in this country, combined with our inability -- as a non-player -- to participate in the ethics and policy discussion): "Human Cloning Marches On, Without U.S. Help" (Feb. 15); and



• from Dale Fuchs a story about a stem-cell bank in Spain: "Bank for Human Stem Cells Starts Ethics Debate in Spain" (Feb. 15).

Interns' diary.

Two interns at a Harvard-affiliated teaching hospital are publishing a 5-day journal this week in Slate: http://slate.msn.com/id/2094977/entry/2095201/. Ingrid Katz (Amherst '93) and her partner, Alexi Wright, are the authors. They are also occasional bloggers (a link to their blog is over there in the left-hand column of this page).

Scalia says "nuts" to recusal for ducks.

Speaking at my alma mater last night, Antonin Scalia provided his most direct answer to date concerning calls for him to recuse himself from a hotly contested APA case involving Dick Cheney, with whom he went duck hunting last month. According to an article in the Boston Globe, Scalia said he saw no conflict of interest. As reported in Slate.com, he added that Cheney hasn't been sued in his personal capacity, only in his official capacity as Veep, and neither the law nor Court tradition prohibits socializing with executive branch officials who are not parties before the Court in their personal capacity.

Stark II, Part 2, regs postponed . . . . again.

The OMB's OIRA Executive Order Submissions Under Review document has been recently revised to show a new "Received" date of 12/7/2003 for the Stark II rule (Part 2):

HHS-CMS RIN: 0938-AK67
Medicare Program; Physicians' Referrals to Health Care Entities
with which they have Financial Relationships -- Phase II
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED: 12/17/2003 LEGAL DEADLINE: None

That means the rule probably won't be out before March 16. Care to make a little wager that it won't be published before summer?

NY Times: Whose Problem Is Health Care?

Nice piece in today's business section of the New York Times by Daniel Gross on the problems of employer-based health care. The story is about a December 2003 report from the Manufacturers Alliance and the National Association of Manufacturers that details the factors that make it difficult for American manufacturers to compete with foreign firms -- not just those in developing countries with low labor costs, but in developed countries as well. One of the culprits that cancels out gains in productivity and cost controls is the structural costs of operating in the US: corporate income taxes, employee benefits, and rule compliance. The article looks particularly at health care costs:

After corporate income taxes, employee benefits are the second-largest structural cost for American manufacturers, adding 5.8 percent to costs, according to the study. In all major economies, paying for health care means a combination of public and private money. But in the United States, businesses pay a larger chunk than do their European and Asian counterparts.

"In Canada, for example, a lot of the expenditures for health are funded out of general revenues," said Jeremy Leonard, an economic consultant for the Manufacturers Alliance, and the report's main author.

In Canada, the private sector spends 2.8 percent of gross domestic product on health care; in the United States, the private-sector figure is 7.7 percent. And American private-sector spending falls disproportionately on big employers like manufacturers. Some 97 percent of members of the National Association of Manufacturers provide health care coverage for employees. In 2002 alone, General Motors, which covers 1.2 million Americans, spent $4.5 billion on health care.

Best quote, predictably, comes from the eminently quotable Uwe Reinhardt, "an economist at Princeton, has referred to General Motors, Ford and Daimler-Chrysler as 'a social insurance system that sells cars to finance itself.'''

The debate is between a governmental program for retiree health care (and can employee health care then be far behind?) and the current, privately financed employer-based approach. The article concludes, "Whatever way, we all pay." Increasingly, though, large employers are looking for ways to shift their health-care costs to a larger denominator (say, all taxpayers). The tradeoff in terms of slight increases in corporate taxes will be more that offset by the many-times-larger reduction in health-care costs. It will be interesting to see if and when the captains of industry start throwing themselves behind a national, single-payer system. . . .

How Appealing's 20 questions site.

I am continually impressed by Howard Bashman's How Appealing's 20 questions site. Students looking for a diverse collection of opinions by sitting appellate judges on the nature of their work -- and, necessarily, their view of the Constitution, Congress, their relationship with the Supreme Court, etc. -- will have a field day on this site. There doesn't appear to be any ideological bias here - the judges represent all points along the two-party political spectrum (apparently no Greens need apply for judicial appointments in this country), and the questions are probing but respectful. Some of my favorite judges are here (e.g., Tacha, Tjoflat, Posner, Richard Arnold, Reinhardt) with, I hope, many more to come.

Scalia and Cheney: Ex parte, or just a party?

The NY Times' Michael Janofsky has a good article in Friday's paper on the ethics fallout from the duck-hunting expedition shared by Associate Justice Antonin Scalia and Vice President Dick Cheney, who is a named party in a major administrative procedure case in which SCOTUS granted review just three weeks before. Senator Patrick Leahy (D.-Vt.) had the best line: "Frankly, I'm puzzled by it. I know Justice Scalia well; he's a very intelligent person. He has to know that with similar tactics, in any state in the country, a State Supreme Court justice would have to recuse himself. It's Law School 101."