Human experimentation research request

From Jim DuBois, PhD, DSc, Mäder Endowed Professor, Department Chair and Center Director, Center for Health Care Ethics & Becky Volpe, Graduate Assistant, Center for Health Care Ethics:

We are studying the personality and environmental factors that contribute to major ethical breaches in the areas of medical practice and research. An example of a major breach would be the Tuskegee syphilis trial. We plan to examine 25-100 cases of “ethical disasters”, and then analyze characteristics of the cases to find relationships, similarities, and differences. We will be including only those cases that occurred after the year 1900 and are documented in published sources.

We had hoped that, given your expertise, you would be willing help us generate a list of possible cases for inclusion. To nominate cases for review, please email Becky Volpe at rvolpe@slu.edu.

Thank you very much for your time.

Medical Futility Blog

I don't know how I missed it, but here (better late than never) is a link to Prof. Thad Pope's estimable Medical Futility Blog, which does a nice job of tracking legal developments and the on-going political and scholarly debate over what to do (if anything) about claims for "futile" treatment.

Health reform: the time for happy chatter is over

Robert Samuelson -- Newsweek columnist and Washington Post op-editorialist -- had a typically fine piece in last Thursday's Post. Here's the nub of his argument:

We're told that the uninsured are our biggest health-care problem, but they aren't. Runaway health spending is. although politicians pay lip service to that, what they really enjoy is increasing spending.

It's understandable because expanding benefits is so much more politically rewarding than trying to control them. Everyone believes in adequate health care; people should have it when they need it. Politicians cater to these beliefs. But the intellectual and even moral laziness of this approach results in an invisible abdication of political responsibility. We are letting the unchecked rise in health spending determine national priorities. Consider:

• Health spending already totals more than $2 trillion annually, about 16 percent of national income (gross domestic product). By 2030, it could easily exceed 25 percent -- one dollar out of four -- projects the Congressional Budget Office.
• There's a massive transfer of income from young to old. Americans 65 and older now represent about an eighth of the population and account for about a third of all health spending. By 2030, their population share will be about a fifth, and they could account for nearly half of health spending, the Centers for Medicare and Medicaid Services has found.
• Neither the government nor the private sector has succeeded in controlling health spending. From 1970 to 2005, average spending per Medicare beneficiary rose 8.9 percent a year. For similar services, spending for Americans with private health insurance rose 9.8 percent annually over the same period. The small difference may reflect cost shifting. When Medicare imposes price controls, doctors and hospitals increase prices for privately insured patients.

Samuelson argues for changes that illuminate rather than obscure the costs of care -- by increased cost-sharing by Medicare beneficiaries, a dedicated federal health-care tax to pay for all federal health programs (as the costs go up, the tax goes up), and elimination of the federal tax subsidy for employer contributions to employee health benefit plans. This is hardly new stuff: all of these ideas have been kicking around for years, and most health care economists seem to agree that cost control won't be possible without reducing the role of third-party payors and putting more of the cost of care on consumers.

Samuelson's contribution to the debate is to point out that the debate so far is largely missing a very big -- possibly the big -- point. Here's why:

These proposals would inflict "pain," and candidates who embraced them would invite political ruin. There's a consensus for evasion that most politicians echo. The impulse is to focus on a simpler problem -- say, the uninsured. In some ways, this is less serious than it seems. About 40 percent of the uncovered are young (18 to 34); most are healthy and don't need much care.

But for all the uninsured, the cost of coverage is a major obstacle. Health care is ultimately a political issue of making choices. Our present politics aims to camouflage the costs and skew the choices. Until we change that, our debates will lead to dead ends.

ACP publishes advance copy of major health reform policy statement

Intending to be a major player in the 2008 debate over health reform and universal coverage, the American College of Physicians has posted an advance copy of an article that will appear in its January 1, 2008, issue of Annals of Internal Medicine: "Achieving a High-Performance Health Care System with Universal Access: What the United States Can Learn from Other Countries." Full-text is available for free here. It's 21 pages long, heavy on statistics, and an indispensable critical analysis of our system's strengths and weaknesses.

On the crucial question of how to achieve universal coverage, the ACP basically punts, presumably because the country isn't (and may never be) politically ready for a single-payer system:

Universal health care insurance is necessary to ensure that everyone within the United States has access to needed health care services of high quality. The federal government should assure that all persons within the borders of the United States also have access to health care services without undue financial barriers and that health care services provided are adequately reimbursed. The ACP recommends two alternatives: a system funded solely or principally by government (federal and states), commonly known as a single-payer system, or a pluralistic system that incorporates existing public and private programs with additional guarantees of coverage and with sufficient subsidies and other protections to assure that coverage is available and affordable for all. The ACP has [elsewhere] proposed a step-by-step plan that would achieve universal coverage while maintaining a pluralistic system of mixed public and private sector funding.

Here's how it ends:

Summary and Conclusions

Health care in the United States has many positive features and in many respects is superb compared with health care anywhere else in the world. Those with adequate health insurance coverage or sufficient financial means have access to the latest technology and the best care. However, as this paper points out, the U.S. health care system is inefficient and inconsistent: Health care quality and access vary widely both geographically among populations, some services are overutilized, and costs are far in excess of those in other countries. Moreover, the United States ranks lower than other industrialized countries on many of the most important measures of health.

Current international comparisons of measures of health (life expectancy at birth, infant mortality, and deaths per 100 000 for diseases of the respiratory system and for diabetes) indicate that population health in the United States is not better than in other industrialized countries despite the greater U.S. expenditures (58). The experience and innovations of health care systems in other countries provide many lessons as the United States tries to improve its health system. Among these lessons are the value of an orientation and emphasis on patient-centered primary care and the importance of assuring a well educated physician workforce that meets the country's need for primary care physicians.

The quality and accessibility of health care in the United States could be improved by adopting reimbursement programs like those in other countries that provide substantial rewards based on performance on quality metrics and care coordination rather than solely on the volume of services provided. These payment systems together with national workforce planning might also help address the impending primary health care workforce shortages in the United States. Universal and compulsory health insurance coverage could eliminate many of the disparities and inequities in the United States. Expanded use of health information technology and substantial governmental investments and support for a health information technology infrastructure with appropriate patient privacy protections could enhance health care decision making by physicians and patients and would bolster the growing movement for consumer-directed health care. These are some of the lessons we can learn from other industrialized countries.

Other lessons for a more efficiently functioning health care system include achieving lower administrative costs by standardizing coverage and insurance transactions; providing coverage through publicly funded programs rather than private insurance; and automating transactions among providers, patient, and insurers. This article does not address many other issues in depth. Topics for further in-depth analysis include the costs and impact of malpractice liability insurance, determination of prescription drug prices, differences in medical education (including costs and student debt), financing long-term care, and physician earnings and income. The United States may also benefit by examining how other countries manage end-of-life care, determine the distribution of health care resources, and make decisions on coverage and benefits.

The ACP has offered a series of recommendations to achieve a well-functioning health care system. All Americans should have access to a primary care physician and should have a patient-centered medical home for their ongoing, continuous,
comprehensive, and coordinated care. All Americans should have health insurance coverage that includes preventive and primary care services, as well as protection from catastrophic health care costs. Federal health policy should support the patient-centered primary care model. The United States lacks a national health care workforce policy. It should provide for sufficient support for the infrastructure required to educate and train an adequate supply of health professionals that would properly meet the nation's health care needs, including primary and principal care physicians that are trained to manage care of the whole patient. Workforce planning should specify an appropriate mix of physicians between primary and specialty care and describe the policies required to achieve that goal. Public and private investments in research must continue to support advances in basic and clinical medical science as well as in health services research. Other ACP recommendations call for financial incentives to encourage quality improvement and reduction of avoidable medical errors, support for a health information technology infrastructure to assist patients and physicians in making informed decisions about the appropriate use of health care services, and use of technology to achieve a more efficient health care system.

The main lesson of this article is that many countries have better functioning, lower cost health care systems that outperform the United States. We must learn from them.

New York City Law Review Issues Call for Papers on Health Care

The New York City Law Review announces a call for papers for its spring symposium, "Critical Condition: What's Ailing Health Care in America?" This event will be held Friday, March 28, 2008, at the Association of the Bar of the City of New York's Meeting Hall in Midtown Manhattan.

The Symposium will look at two critical questions: (1) Can international human rights frameworks help the United States overcome obstacles to universal coverage? and (2) Can innovative litigation expand coverage to vulnerable populations? Given that the 2008 general election has already placed health care as a central campaign theme, now is a critical time to evaluate the practical litigation and policy models for providing access to the uninsured and vulnerable populations, says Matthew Monroe, one of the symposium's organizers. For more details on the symposium and how to make topic submissions, visit: http://www.nyclawreview.org/

AHLA Health Lawyers Weekly, Nov. 30

Some interesting stuff in the Health Lawyers Weekly this time around:

Top Stories

• OIG Takes Back Power To Investigate Employee Criminal Conduct From FDA -- The Department of Health and Human Services Office of Inspector General (OIG) will no longer share responsibility with the Food and Drug Administration (FDA) for investigating potential criminal misconduct by FDA employees, Inspector General Daniel Levinson said in a September letter to FDA Commissioner Andrew C. von Eschenbach. Full Story


• CMS Releases List Of 54 Worst Performing Nursing Homes -- The Centers for Medicare and Medicaid Services (CMS) has released the first ever list of the nation's 54 poorest performing nursing homes, the agency said in a November 29 press release. Full Story

Articles & Analyses

• Illinois Hospitals Face Conflicting Requirements Regarding Nurse Staffing, by Janice A. Anderson and Anne M. Cooper, Foley & Lardner LLP

Current Topics

• Antitrust
  [1] AHA Presses DOJ To Block Health Plan Merger
  [2] FTC Reaches Settlement With Barr Involving Oral Contraceptive Drug


• Arbitration/Mediation
  California Appeals Court Finds Nursing Home Arbitration Agreements Invalid


• Criminal Law
  Prominent Plaintiffs’ Attorney Indicted For Attempting To Bribe Judge


• EMTALA
  U.S. Court In Indiana Finds Plaintiff Alleging EMTALA Violations Cannot Amend Complaint To Seek Damages Under § 1983


• Fraud and Abuse
  Michigan Appeals Court Reverses Dismissal, Remands Medicaid Fraud Case For Trial


• Update


• Healthcare Access
  [1] CMS Approves Wisconsin’s Plan To Expand Eligibility For Its SCHIP Program
  [2] Hospitals Face Increasing Challenges In Obtaining Emergency On-Call Coverage From Specialists, Study Says


• Hospitals and Health Systems
  Florida Appeals Court Upholds State Agency’s Decisions Allowing Hospitals To Recover Payments From Workers’ Compensation Carriers


• Managed Care
  [1] Health Net Fined $1 Million For Failing To Disclose Compensation Based On Plan Rescission
  [2] NY Physician Ranking Model To Become State Law


• Medicaid
  U.S. Court In Delaware Holds State’s Residency Requirement For Medicaid
  Eligibility Violated Constitutional Right To Travel


• Medical Malpractice
  [1] Washington Appeals Court Holds Malpractice Plaintiff May Not Rest Informed Consent Claim On Evidence Of Physician’s Inexperience
  [2] Georgia Appeals Court Finds No Right To Indemnity Where Liability To Pay Judgment Not Compulsory
  [3] Florida Appeals Court Finds Medical Malpractice Plaintiff Presented Sufficient Expert Testimony To Proceed To Trial
  [4] Iowa Appeals Court Remands Medical Malpractice Case For New Trial, Finding Abuse of Discretion In Lower Court’s Rulings


• Medicare
  [1] Lawsuit Seeks Medicare Part D Coverage Of Drugs For Medically Necessary Off-Label Uses
  [2] Medicare Continues To Reduce Improper Claims Payments, CMS Says
  Eighth Circuit Rejects MSP Action By Individual Claiming Standing As Qui Tam Relator
  [3] CMS Issues Report To Congress On Medicare Hospital Value-Based Purchasing


• News in Brief
  GlaxoSmithKline Agrees To $1.4 Million Settlement With Texas


• Patient Safety
  Massachusetts Hospitals Will Not Charge For Adverse Events


• Physicians
  [1] Washington Appeals Court Affirms Sanctions Against Physician For Unprofessional Conduct
  [2] U.S. Court In Washington Finds Hospital Did Not Violate Physician’s Civil Rights In Denying Application For Privileges

(c) 2007, American Health Lawyers Association. Reprinted by permission.

Informed consent & SCOTUS: A tale of two doctrines

Interesting paper . . .

The Constitutional Right to Make Medical Treatment Decisions: A Tale of Two Doctrines
JESSIE HILL
Case Western Reserve University - School of Law
Texas Law Review, Vol. 86, No. 2, December 2007
Case Legal Studies Research Paper No. 07-28

Abstract:

The Supreme Court has taken very different approaches to the question whether individuals have a right to make autonomous medical treatment choices, depending on the context. For example, in cases concerning the right to choose “partial-birth” abortion and the right to use medical marijuana, the Supreme Court reached radically different results, based on radically different reasoning.

More recent developments, including last Term's decision in Gonzales v. Carhart, have only highlighted the doctrinal confusion and the need for a resolution. In light of this pressing need, the goal of this Article is to view all of the constitutional cases touching on medical treatment decisions as one body of doctrine, as no other scholar has done. And indeed, this new perspective reveals that there are in fact two distinct lines of constitutional doctrine touching on the right to make medical treatment decisions: the “public health” line of cases, which emphasizes the police power of the state over individual rights, and the “autonomy” line of cases, which emphasizes individual bodily integrity and dignitary interests. Those lines of cases have grown up in parallel, appearing to represent airtight doctrinal categories while in fact addressing the same fundamental question. In addition, courts have applied varying degrees of deference to legislative determinations of medical fact without any logical consistency, perhaps based on largely superficial determinations about what type of case is before it.

This Article concludes that a constitutional right to protect one's health should be consistently recognized; that the recognition of this right should not be artificially limited by excessive deference to legislative findings of medical fact; and that this right will have to be carefully balanced against the state's real and legitimate interest in regulating the practice of medicine to protect the public.

Top Ten Health Law Stories in 2008: FDA

There's no denying either the urgency of the FDA's mess or the bipartisan political appeal of the issue of food and drug safety. Consider this lead from the New York Times' Nov. 29 article on the latest report describing the agency's woes:

The nation’s food supply is at risk, its drugs are potentially dangerous and its citizens’ lives are at stake because the Food and Drug Administration is desperately short of money and poorly organized, according to an alarming report by agency advisers.

The report can be found here. (If the lack of an easily navigable website is any indication of agency disorganization, the FDA must be the poster child for agency chaos. This report is almost impossible to find using any of the links on the website. Then again, considering the devastating critique contained in the report, maybe the powers-that-be are trying to make it hard to find.)

Here are some of the major findings:

• The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
  
• FDA does not have the capacity to ensure the safety of food for the nation.
• The development of medical products based on “new science” cannot be adequately regulated by the FDA.
• There is insufficient capacity in modeling, risk assessment and analysis.
• FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.


• The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
• The FDA has substantial recruitment and retention challenges.
• The FDA has an inadequate and ineffective program for scientist performance.
• The FDA has inadequate funding for professional development.
• The FDA has not taken sufficient advantage of external and internal collaborations.


• The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
• The Subcommittee believes that there is evidence of important, but slow, progress to improve information sciences and technology at the FDA over the past few years, yet significant gaps remain.
• The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.
• The FDA cannot provide the information infrastructure support to regulate products based on new science.
• The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services.
• The IT workforce is insufficient and suboptimally organized.

If that's not enough to make your Post Toasties wilt, I don't what is . . . .

WSJ: Health policy caps mean catastrophic coverage may not be there when needed

Yesterday's WSJ ran a story that highlights the plight of the insured middle-class in this country: It's possible to max out a health policy with a $1.5 million cap in the metaphorical blink of an eye. The story is here (though it may require a paid subscription to read it).

When hospice patients don't die quickly enough, Medicare comes knocking

Some years ago, the Medicare program proposed to recoup hospice payments if a patient didn't die within 6 months, which was the probable life-expectancy that a physician had to certify for a patient to receive the Medicare hospice benefit. As I recall, that proposal was met with howls of protest and dropped.

What Medicare couldn't do directly, however, it is now doing indirectly, as described in an article in today's New York Times. With an annual cap on total hospice payments ($21,470 [slightly less than six months of daily payments of $135] x the total number of hospice patients served in a year), Medicare can recoup "excess" payments from any hospice that received reimbursement from the program above the annual cap. In some cases, the amount of recoupment is in the high six figures. The hardship on hospice programs is palpable -- most don't have the kind of profit margins that allow them to pay back to Medicare a year or more after the money has been spent on salaries, supplies, and other overhead.

Part of the problem for some hospices may be bad patient mix (i.e., not enough terminal cancer patients with more predictably short life expectancies), and there may be management issues, as well. But shouldn't there be a better solution to this problem than penalizing hospices whose patients don't die fast enough to satisfy federal regulations? As one physician is quoted in the article, "Doing this for 40-something years, every time I think somebody is going to die tomorrow, damned if they don’t live for a year and a half." Do we really want to have a federal policy that regards that result as a failure?

Krugman: Health Care Excuses

Okay, I know he's a liberal (Exh. 1: "The Conscience of a Liberal"), and so am I, so there are times when I suppose Paul Krugman's arguments seem irresistible when they're not. But today's column strikes me as just plain common-sensical.

Krugman offers up four common excuses often used to argue against health reform and then refutes them. It is worth a read. Here are the excuses:

• Excuse No. 1: No insurance, no problem.


• Excuse No. 2: It’s the cheeseburgers.


• Excuse No. 3: 2007 is better than 1950.


• Excuse No. 4: Socialized medicine! Socialized medicine!

And, by the way, a big shout out to the managers at The New York Times who have stopped putting the good stuff where only subscribers could get to it. I don't know what their new business plan is, or how they can afford it, but I am grateful for total Web access (i.e., the same as The Washington Post). As a subscriber, I've always had it, but as a blogger it was frustrating not being able to share so much as a link. Those days are now blissfully over!

Insurer misconduct alleged in California

From today's Modern Healthcare:

Calif. insurance chief probes report of cancellations

California’s insurance commissioner is investigating a report that Health Net rewarded an analyst more than $20,000 in bonuses tied to canceling individual health insurance policies, thereby saving the company millions in medical expenses.

“We certainly view this as a serious breach,” said Byron Tucker, spokesman for state Insurance Commissioner Steve Poizner.

The Los Angeles Times reported that Health Net revoked 1,600 policies between 2000 and 2005, saving the Woodland Hills, Calif.-based insurer $35.5 million in medical payments. The company set policy rescission targets, which the senior analyst in charge of cancellations regularly exceeded, earning her praise and monetary rewards, according to the newspaper.

Tying compensation of claims reviewers to their actions is illegal under state law.

“The characterization of our compensation programs is inaccurate and misleading,” Health Net said in a written statement.

The bonuses were disclosed during an arbitration hearing on a $6 million lawsuit brought by a 51-year-old hairdresser from the Los Angeles area whose Health Net policy was revoked during her chemotherapy treatments for breast cancer. The Times’ lawyers intervened to have the documents unsealed, according to the newspaper.

Here's a link to the LA Times article that broke the story. The picture quality is pretty bad, but you can see from copies of the insurance analyst's performance review (above) that she was being evaluated, at least in part, on the basis of the number of rescissions she produced and the corresponding contribution she made to the company's bottom line.

Deputies seize baby to test blood against parents' will

Deputies seize baby to test blood against parents' will - Associated Press -- Here's a nicely framed conflict between public health laws designed to protect newborns vs. parental religious beliefs, in state (Neb.) that doesn't provide a religious exemption for newborn testing. Absent a First Amendment claim (which would fail), the only constitutional argument would be a claimed infringement of the parent's liberty interest in violation of the due process clause . . . rational basis review . . . slam dunk for the county. This falls into the same class of cases involving Jehovah's Witness minors in need of a blood transfusion.

Iglehart on the House's failure to override Bush's SCHIP veto

John Iglehart, the founding editor of Health Affairs and national corespondent for the New England Journal of Medicine, posted his instant analysis [may require paid subscription] of the House's failure on Thursday to override the President's veto of the SCHIP reauthorization bill, HR 976. Iglehart's provides an excellent overview of the controversy and connects this contretemps to "the larger issue of what level of public support uninsured people deserve as our employer-based insurance system continues to erode." Excellent read.

Federeal employees' health plan not much of a model for reform

There's a good analysis of the Federal Employees Health Benefits Plan (FEHBP) by Reed Abelson in The New York Times today. Various presidential candidates are talking about the FEHBP in their stump speeches, suggesting that this country's 47 million uninsured could be covered by the same plan that covers their elected representatives. Bottom line: There's really nothing about the FEHBP that would either materially improve the uninsureds' access to health insurance or help to rein in costs. It's a private-insurance system with insurers competing for business. Underwriting, including favorable selection, and generous benefits largely replicate the problems the rest of us experience in our own private, employment-based system, and expanding FEHBP to 8 times more individuals than it currently covers would require changes in the program that would render it "FEHBP" in name only.

Major-party presidential candidates on health reform

This summary is not available. Please click here to view the post.

SCHIP

Here's a news post courtesy of FDLI's SmartBrief:

White House to face state SCHIP lawsuits -- New Jersey was the first of several states expected to file lawsuits against the Bush administration over rules set in August that limit state coverage of children's health insurance to exclude children in middle-income families. Arizona, California, Illinois, Maryland, New Hampshire, New York and Washington also say they plan to file or support lawsuits challenging the rules, claiming that the income limits set by the administration breach federal government authority on SCHIP and make it more difficult for them to provide coverage for children. "Our chief goal with SCHIP is to ensure that the poorest kids and those with no health insurance are placed at the front of the line," a CMS spokesman countered. Courier-Post (Camden-Cherry Hill, N.J.) (10/2), The Washington Post (10/2), Forbes/Associated Press (10/1).

Interesting development, this. This issue of whether higher eligibility cutoffs for SCHIP will put on the federal dole middle-class kids who would otherwise be covered by private insurance is at the heart of the White House's veto of the new SCHIP authorization bill (H.R. 976), too. Terence Hunt is reporting (AP/Washington Post) this afternoon that Pres. Bush has announced his intention to veto the SCHIP reauthorization bill on Wednesday, and that there will be no ceremony for the television cameras. Too bad: I was hoping to be able to post the YouTube video of the veto ceremony. Guess I'll have to go with something else . . . .

Sen. Susan Collins (R-Me.)

FDA's oversight of human-subject research: slim to none

That's the bottom line of a report from the Inspector General of DHHS, according to an article in the New York Times. The IG's report (pdf), and a news release (pdf) about its conclusions, were released today. In his typically media-friendly way, Art Caplan colorfully summarized the report's conclusions this way: "In many ways, rats and mice get greater protection as research subjects in the United States than do humans."

Health Lawyers Weekly, September 14

Crowell & Moring partner Art Lerner and counsel Michael Paddock have an analysis of the FTC's recent Evanston Northwestern Healthcare Corp. decision in this week's Health Lawyers Weekly from the AHLA. The decision, in which the Commission held that Evanston's acquisition of Highland Park Hospital violated Section 7 of the Clayton Act but declined to order divestiture, was a rare if not unprecedented response for the FTC.

Other items of note from this week's issue:

Top Stories

• CMS Denies New York’s Plan For Expanding SCHIP, Opposition To New Policy Mounts
• Aventis Pays Over $190 Million To Settle FCA Claims Alleging Fraudulent Drug Pricing And Marketing Practices

Current Topics include Antitrust, Business Transactions, Fraud and Abuse, Healthcare Access, Healthcare Spending, Hospitals and Health Systems, Insurance, Managed Care, Medical Malpractice, Medicare, Physicians, and Tax.

Vatican reaffirms stance on obligatory nature of ANH

"The administration of food and water even by artificial means is, in principle, an ordinary and proportionate means of preserving life. It is therefore obligatory to the extent to which, and for as long as, it is shown to accomplish its proper finality, which is the hydration and nourishment of the patient. In this way suffering and death by starvation and dehydration are prevented." And ANH is just as ordinary and proportionate, and therefore just as mandatory, when the patient is in a permanent vegetative state.

This is from the recently posted "Responses to Certain Questions of the United States Confernce of Catholic Bishops Concerning Artificial Nutrition and Hydration," issues by the Congregation for the Doctrine of the Faith and, as if it needed to be said, "The Supreme Pontiff Benedict XVI, at the Audience granted to the undersigned Cardinal Prefect of the Congregation for the Doctrine of the Faith, approved these Responses, adopted in the Ordinary Session of the Congregation, and ordered their publication." The English translation is here, and the official commentary is here.

The big questions now are what will be the effect of these statements on health care decisions by Catholics and on the policies of Catholic healthcare institutions.

Insuring the uninsured: the right thing to do, but what's in it for me?

Today's New York Times has an article on the new round of health-care reform proposals that are being advanced by various presidential candidates. On the dim prospects for any of the proposals to extend coverage to the uninsured and improve coverage for the underinsured, the article makes the following point:

In short, altruism has its limits, as does the public’s appetite for trade-offs in their own lives for the sake of the uninsured, said Bill McInturff, a Republican pollster who worked for the insurance industry in 1993 and 1994. “Never, in my years of work, have I found someone who said, ‘I will reduce the quality of the health care I get so that all Americans can get something,’ ” he said. “Every time the debate reaches that point, it collapses.”

This time, candidates are emphasizing the benefits for people who already have insurance — lower costs for coverage, new programs to improve the quality of health care. “Everyone has to feel, at the end of the day, that they will get something,” said one Clinton adviser.

By coincidence, the September/October issue of Health Affairs offers an answer:

Expanding coverage to the forty-seven million Americans who now lack health insurance could greatly improve care for people who already are protected. Economists Mark Pauly of Wharton and José Pagán of the University of Texas-Pan American found that insured adults who live in communities with high uninsurance rates are more likely to face problems with access to care and quality than those who live in communities where more people are covered.

The link to the abstract of the Pauly-Pagan article ("Spillovers And Vulnerability: The Case Of Community Uninsurance") is here.

Drake Law School looking for health law/insurance law teacher

Faculty opening at Drake:

DRAKE LAW SCHOOL seeks applications for a tenure-track position in the area of health law, insurance law and related fields commencing in the 2008-09 academic year. We are interested in both entry-level and experienced candidates with a J.D. degree and strong academic credentials who exhibit the ability to produce excellent scholarship and become outstanding teachers. Applicants who will contribute to the diversity of the faculty are particularly encouraged to apply. Drake University is an equal opportunity employer and actively seeks applicants who reflect the diversity of the nation. No applicant shall be discriminated against on the basis of race, color, national origin, creed, religion, age, disability, sex, gender identity, sexual orientation or veteran status.

Contact: Professor Cathy Lesser Mansfield, Chair, Faculty Recruitment Committee, Drake Law School, 2507 University Ave., Des Moines, IA 50311 or e-mail: cathy.mansfield@drake.edu.

Medicare beneficiaries lag in taking advantage of covered screenings and preventive care

From the Wall Street Journal (via AHLA's Health Law Daily [link should be good for about a week]):

CMS says Medicare is spending more on prevention efforts. The Wall Street Journal (8/26, McQueen) reported, "Medicare, the federal health-insurance program for older Americans, increasingly is paying for screening tests and immunizations that previously were not covered. But the vast majority of recipients are failing to take advantage, officials say." Less than 10 percent of Medicare recipients are "getting all the screenings and immunizations recommended by public health groups," according to the CMS. And, just over "a third of recipients didn't get a free flu shot in 2005, for example, even though elderly and immune-system-compromised patients are at high risk of death from the disease." In order to reverse this trend, "Medicare officials launched a bus tour of 48 states and more than 120 cities this summer, in conjunction with local officials, hospitals and elder-care groups. The tour is expected to wrap up this week." The Journal noted, "Until now, just five percent of Medicare spending has been for preventive services, officials say. But in recent years, as medical evidence has mounted about the cost-effectiveness of preventing diseases such as flu, diabetes and heart disease instead of treating them later, the U.S. has authorized more spending on screening tests and immunization."

This caught my eye for a couple of reasons. First, it is scandalous that Medicare beneficiaries aren't getting the preventive services they need to fend off really serious and expensive health problems. Of course, the reason might be that the elderly haven't gotten the word about changes in Medicare coverage for such items. But it might also be because of other impediments such as limited transportation, the extra burden from multiplying trips to providers of different kinds to get the screenings done, etc. But at least CMS is focusing on the easiest-to-solve part of the problem by trying to do a better job of getting the word out.

Second is the statement that "medical evidence has mounted about the cost-effectiveness of preventing diseases such as flu, diabetes and heart disease instead of treating them later." This is certainly conventional wisdom, and this argument has an undeniable, intuitive appeal. But is it true?

There is evidence to support the proposition, at least within a limited time frame and for certain medical conditions and certainly for the individual who, as a result of the screening or the flu shot, didn't get sick. For example, as the New York Times reported [TimesSelect article: no link available] on January 11, 2006, in an article about diabetes prevention:

Insurers, for example, will often refuse to pay $150 for a diabetic to see a podiatrist, who can help prevent foot ailments associated with the disease. Nearly all of them, though, cover amputations, which typically cost more than $30,000.

Patients have trouble securing a reimbursement for a $75 visit to the nutritionist who counsels them on controlling their diabetes. Insurers do not balk, however, at paying $315 for a single session of dialysis, which treats one of the disease's serious complications.

But what if avoiding the life-threatening acute medical condition simply permitted a large percentage of patients to survive for a life-time of care for their chronic conditions. Isn't it at least possible that the cost savings would eventually be exceeded by the costs associated with a longer life-time of care? That seems to have been the thrust of a March 16, 1997, article in the Times [also TimesSelect (no link)]:

While studies have shown that preventive care is generally good for your health, they have also shown that it often does not save money.

The central problem is that the early detection of many diseases, like high cholesterol and H.I.V. infection, is often followed by a lifetime of costly treatments and drugs. Expensive hospitalizations may only be forestalled. So in many cases, total medical costs actually rise.

''An awful lot of preventive care has no payoff economically -- it actually costs money,'' said Uwe Reinhardt, a health economist at Princeton University. ''If the [managed care] plans are doing it, they're doing it because they think it gives them a good image. A lot of this stuff is overhyped.''

That's the message, again, from the recent essay by David Leonhardt, "Free Lunch on Health? Think Again" (NY Times, Aug. 6, 2007; TimesSelect [no link]). Leonhardt notes that Rudy Giuliani and the three leading Democratic presidential candidates (Clinton, Edwards, Obama) are all promoting the idea that

[b]y practicing preventive medicine, doctors can keep many people from getting sick in the first place. Those who do end up with a chronic illness will be closely tracked so that fewer of them develop complications. These steps will result in less illness, which in turn will require less health care. With the savings, the country can then lower its medical bills or provide health insurance for the 40-odd million people who lack it -- or maybe even both.

As Hillary Clinton recently told The Atlantic, it's possible to ''save money
and improve quality and cover everybody.''

The hitch, according to Leonhardt, is that

[n]o one really knows whether preventive medicine will save money in the long run, let alone free up the billions of dollars a year needed to help pay for universal health insurance. In fact, studies have shown that preventive care -- be it cancer screening, smoking cessation or plain old checkups -- usually ends up costing money. It makes people healthier, but it's not free.

''It's a nice thing to think, and it seems like it should be true, but I don't know of any evidence that preventive care actually saves money,'' said Jonathan Gruber, an M.I.T. economist who helped design the universal-coverage plan in Massachusetts.

This is a tough idea to swallow because better health really does seem as if it should lead to lower medical bills. Indeed, if it were somehow possible to wave a wand and turn people into thin nonsmokers who remembered to take their statins, this country's health care expenses would fall.

But any effort to promote health has its own costs. Doctors and nurses need to spend time with patients to persuade them to change their behavior. (Ever tried to get someone to stop smoking or drinking?) For a new program to work, it has to reach people who are not being helped by whatever exists now -- and who thus will be among the most difficult and expensive patients to treat. The program would also have to treat a whole lot of people who never would have gotten sick.

Jay Bhattacharya, a doctor and economist at Stanford's School of Medicine, estimates that to prevent one new case of diabetes, an antiobesity program must treat five people -- ''not cheaply,'' he says. Along the same lines, Mr. Gruber found that when retirees in California began visiting their doctor less often and filling fewer prescriptions, overall medical spending fell. People did get sick more often, but treating their illnesses was still less costly than widespread basic care -- in the form of doctors visits and drugs. Louise Russell, an economist at Rutgers, points out that programs that focus on at-risk patients cost the least, but even they are rarely free.

As Dr. Mark R. Chassin, a former New York state health commissioner, says, preventive care ''reduces costs, yes, for the individual who didn't get sick.''

"But that savings is overwhelmed by the cost of continuously treating everybody else.''

The actual savings are also not as large as might at first seem. Even if you don't develop diabetes, your lifetime medical costs won't drop to zero. You might live longer and better and yet still ultimately run up almost as big a lifetime medical bill, because you'll eventually have other problems. That would be an undeniably better outcome, but it wouldn't produce a financial windfall for society.

Certainly, there are examples of preventive care that can save money. As Mrs. Clinton has noted, Safeway and a handful of other companies have held down health costs by emphasizing prevention. (This, of course, is only over the short term.) Perhaps the best examples fall under the category of what Dr. Brent C. James calls 'do it right the first time.''

Dr. James is an executive at Intermountain Healthcare, a network of hospitals in Utah and Idaho that has saved money in recent years by reducing hospital infections and drug errors. Intermountain hospitals have also largely stopped inducing child labor for the sake of doctors' or parents' convenience. The hospital induces birth only for medical reasons -- and the number of babies that spend time in the neonatal intensive care unit has fallen.

It's this last example that holds the real key to cutting medical costs. I realize many
people will react to the notion that preventive care usually costs money by saying, ''So what? We should do it anyway.'' And we should.

But by describing it as an easy win-win solution, the presidential candidates are gliding over an important part of the issue. Preventive care saves real money only when it replaces existing care that is expensive and doesn't do much, if any, good. There are plenty of examples of such care -- from induced labor to many lumbar surgeries and cardiac stent procedures.

The problem is that the people getting this care typically don't consider it wasteful. We all like to believe that other people are the ones getting the unnecessary care. We, on the other hand, are probably not getting enough treatment.

Persuading people otherwise -- persuading them that basic care is sometimes cheaper and better -- will be difficult. Sometimes insurance plans will simply have to say no to questionable care, over the opposition of doctors' groups with a financial interest in the status quo. But it's the only way to ''save money and improve quality and cover everybody,'' as Mrs. Clinton says.

This is one of the best articles I've seen in the popular press that explores some of the variables in the "pay for increased coverage by increasing cost-effective primary and preventive care" argument. The problem is -- should we be surprised? -- much subtler and more difficult than our political candidates are making it sound.

Tax-exempt hospitals and "community benefit"

This is a bit tardy but well worth noting here and reading the underlying documents as time permits. In July the IRS issued an interim report on community benefit in the hospital industry (news release), based upon responses to its 2006 questionnaire to 500 hospitals. The Service's main finding: "The report contains preliminary findings on how hospitals, one of the largest components of the tax-exempt sector, responded to questions about how they provide community benefit and meet required standards. The IRS continues to analyze the data and work continues on assessing executive compensation paid by non-profit hospitals." As noted by Leigh Griffith, Don Stuart, and Terri Cammarano, (of Waller Lansden Dortch & Davis, LLP, Nashville, TN) in an email alert to members of the AHLA Tax and Finance Practice Group, the IRS interim report came out "shortly after the Minority Staff of the Senate Finance Committee released its discussion paper on its concerns with nonprofit hospitals." The Minority Staff discussion paper is here.

Health Lawyers Weekly, August 10

The AHLA's Health Lawyers Weekly features two articles by lawyers from Hall, Render, Killian, Heath & Lyman, P.S.C., on the IRS' publication in the July 26 Federal Register of its final rule for 403(b) plans (a/k/a tax-deferred annuity plans) and DOL's simultaneous publication of Field Assistance Bulletin 2007-02 containing guidance on how 403(b) plans can avoid compliance with ERISA.

This week's issue also has a good piece on the DC Circuit's en banc decision in the Abigail Alliance case (previously discussed here).

Top Stories

• D.C. Circuit Says Terminally Ill Do Not Have Constitutional Right To Experimental Drugs
  Terminally ill patients do not have a constitutionally protected right to assume the risk of taking experimental drugs that have passed early safety trials but have not yet been cleared by the Food and Drug Administration (FDA) as safe and effective, the D.C. Circuit held August 7 in an 8-2 ruling. Full Story
• FTC Rules Evanston-Highland Merger Anticompetitive But Declines To Order Divestiture
  In a unanimous ruling released August 6, the Federal Trade Commission (FTC) found the 2000 merger of Evanston Northwestern Healthcare Corp. (ENH) and Highland Park Hospital violated federal antitrust laws. But significantly, the Commission’s ruling, written by Chairman Deborah Platt Majoras, does not require ENH to divest its Highland Park acquisition as ordered by an agency Administrative Law Judge (ALJ) in 2005. Full Story

Articles & Analyses

• IRS Finalizes 403(b) Regulations, By Jay P. Turner, Hall, Render, Killian, Heath & Lyman, P.S.C.
• Labor Department Clarifies Application Of ERISA To 403(b) Plans, By William D. Roberts, Hall, Render, Killian, Heath & Lyman, P.S.C.

Current Topics

• Arbitration/Mediation
  Mississippi High Court Finds Family Of Deceased Nursing Home Resident Not Bound By Arbitration Provision Signed By Relative
• Criminal Law
  Tenth Circuit Affirms Prison Sentence For Physician Who Committed Healthcare Fraud
• Food and Drug Law
  1. Federal Circuit Finds Federal Patent Law Preempts D.C. Law Regulating Drug Pricing
  2. Dingell Introduces Bill Imposing User Fees On Food And Drug Imports
  3. Lawmakers Pledge Work On FDA User Fee Reauthorization Legislation Will Continue In August
  4. Grassley Questions FDA About Oversight Of Drugs Manufactured Abroad
• Fraud and Abuse
  1. Seventh Circuit Upholds Dismissal Of FCA Qui Tam Action Against Caremark Rx For Failure To Plead With Particularity
  2. Update
  3. OIG Approves Nevada, New York False Claims Acts
• Health Information
  Technology
  DHHS Releases White Paper On Creating Public-Private AHIC Successor
• Healthcare Access
  Report Recommends Policy Changes To Further Expand Health Insurance Coverage To Young Adults
• Insurance
  Regence Blue Shield Settles Lawsuit Over High Performance Network
• Long Term Care
  Equitable Abstention Doctrine Supports Dismissal Of Consumer Lawsuit Against Healthcare Facilities For Alleged Violations Of Minimum Nurse Staffing Law
• Managed Care
  New York Governor Spitzer Signs Managed Care Reform Law
• Medicaid
  Eighth Circuit Upholds Denial Of State Request For Increase In Medicaid Payments
  OIG Says New York Paid Over $17 Million In Improper SCHIP Payments
• Medicare
  1. Baucus, Grassley Introduce Bill Revamping QIO Program
  2. U.S. Court In District Of Columbia Finds Pharmacy Associations Lacked Standing To Bring Lawsuit On Behalf Of Its Member Pharmacies
• Physicians
  New York Appeals Court Upholds Physician’s License Suspension Following Conviction For Violating Anti-Kickback Statute
• PRRB
  CMS Administrator Update
• Tax
  Wisconsin High Court Finds Nonprofit Medical Center Not Entitled To Property Tax Exemption On Its Day Care Facility

© 2007 AHLA. Reprinted with permission.

NY Times editorial on why the U.S. doesn't have the world's best health system

The Times' editorial looks at the Commonwealth Fund's recent international report card that compared the U.S. with Australia, Canada, Germany, New Zealand, and the U.K. In the words of the Commonwealth Fund:

the U.S. health care system ranks last or next-to-last on five dimensions of a high performance health system: quality, access, efficiency, equity, and healthy lives. The U.S. is the only country in the study without universal health insurance coverage, partly accounting for its poor performance on access, equity, and health outcomes. The inclusion of physician survey data also shows the U.S. lagging in adoption of information technology and use of nurses to improve care coordination for the chronically ill.

Bottom line for the New York Times editorialist:

With health care emerging as a major issue in the presidential campaign and in Congress, it will be important to get beyond empty boasts that this country has “the best health care system in the world” and turn instead to fixing its very real defects. The main goal should be to reduce the huge number of uninsured, who are a major reason for our poor standing globally. But there is also plenty of room to improve our coordination of care, our use of computerized records, communications between doctors and patients, and dozens of other factors that impair the quality of care. The world’s most powerful economy should be able to provide a health care system that really is the best.

The Commonwealth Fund's report card on U.S. states (previously mentioned here) is also worth a close look.

DC Circuit (en banc) reverses panel decision in Abigail Alliance case

The much-anticipated en banc decision of the D.C. Circuit came down today. The court ruled, 8-2, that dying patients do not have a fundamental right of access to drugs that have either just completed Phase I testing or are in Phase II. The big surprise to me was that no-one on the court joined the two judges -- Chief Judge Ginsburg and Judge Rogers -- who comprised the majority in the original panel. The idea of a new fundamental right seemed far-fetched and unlikely to go anywhere, but not one of the other eight judges on the court saw the issue the same way as the dissenters? This will be a good case for my fall Health Law class -- useful overview of the drug-approval process, good discussion of fundamental-rights law, and an example (if they didn't get this in Con Law II) of how the framing of the claimed right (narrow and specific vs. broad and general) will usually dictate the outcome of the case.

Next stop: Supreme Court. What are the chances four justices will vote to grant cert.? I'll venture a guess: 5% (never say never, but this case comes very close to a zero-percenter).

• AP story
• today's en banc ruling (including Judge Rogers' dissent)
• original 3-judge panel ruling
• Lyle Denniston's same-day analysis at SCOTUSBlog

Security issues for hospitals

Scary words: "Hospital = Target"

In this week's Health Lawyers Weekly, Mark Rogers analyzes hospital-security issues in a post-9/11 world. The risk is anything but speculative, as this list demonstrates:

Several incidents since the attacks of 9/11 have highlighted this risk. Consider
the following:

• November 2002: The Federal Bureau of Investigation (FBI) issued an alert to hospitals in San Francisco, Houston, Chicago, and Washington, D.C., warning of a vague, uncorroborated terrorist threat.


• August 2004: The FBI and U.S Department of Homeland Security (DHS) issued a nationwide terrorism bulletin that al-Qaeda may attempt to attack Veterans Affairs Hospitals as an alternative to more heavily guarded U.S. military institutions. The bulletin indicated that there had been persistent reports of suspicious activity at medical facilities throughout the United States.


• November 2005: Police in London, England arrest two suspected terrorists accused of plotting a bomb attack. One of the suspected terrorists was found to have a piece of paper with the words in Arabic, “Hospital = Target.”


• April 2005: FBI and DHS investigated incidents of imposters posing as hospital accreditation surveyors. The Joint Commission sent security alerts to the 5,000 medical institutions it accredits and warned them to be on the lookout for suspicious activity.


• July 2007: Eight individuals, all of them either physicians or other medical professionals associated with Britain’s National Health Service, were taken into custody in relation to attempted car-bomb attacks in London and a car-bomb attack at Glasgow Airport in Scotland. The FBI reported that two of the suspects contacted the Philadelphia-based Educational Commission for Foreign Medical Graduates to inquire about working in the United States as physicians.

Worth reading (as is the rest of this news-filled issue) . . . .