Saturday, June 02, 2007

Dutch reality tv program -- "Big Donor Show" -- a hoax

Wouldn't you know: One of the stories that lured me out of semi-retirement and back to HealthLawBlog -- the one about the Dutch tv network that was about to air a show featuring a terminally-ill patient interviewing three candidates in kidney failure to decide which one would get her kidney -- turns out to be a hoax by the network, designed to pressure government officials to reform organ-transplantation laws in the Netherlands. According to the AP (courtesy of The Washington Post), the terminally-ill patient was simply a role played by a Dutch actress (Leonie Gebbink, looking none-too-ill in her publicity shot).

It appears that organ-transplant officials the world over are a pretty conservative lot, adverse to publicity that could be seen as sensationalistic in any way, and of course there was plenty about this "show" not to like. But count this episode as one of many that illustrate the widespread feeling of frustration that "business as usual" isn't getting the job done in the organ-transplant field. The waiting-list statistics at UNOS tell a pretty grim tale:
  • there are currently 96,047 registered patients on various waiting lists

  • over the past 5 years, waiting-list registrations have skyrocketed for livers, kidneys, and lungs; the number of transplants has increased modestly, and the number of patients who died waiting for a transplant has either gone up modestly (livers and kidneys) or stayed about the same (lungs) despite heroic efforts to increase donations; for hearts, the number of deaths on the list has gone down slightly, but not because of an increase in the number of transplants, which has stayed about the same:

[click to enlarge]







Historians of organ transplantation may well look back on 2007 as the year of the first big crack in the facade. I am thinking of HHS' opinion earlier this year that the prohibition against buying and selling organs (42 U.S.C. § 274e) would not be violated by paired exchanges of living donor kidney transplants. This is the situation when A donates a kidney to D in exchange for C's donation of a kidney to B, where A would otherwise be a living related donor to B, and C would otherwise be a living related donor to D, but for A-B and C-D incompatibility. (A variation on this theme occurs when a living related donor who is incompatible with a family member on the waiting list donates to a stranger, in exchange for which the patient on the waiting list receives some priority on the waiting list, which may substantially shorten his or her waiting time.) Every first-year Contracts student can spot the valuable consideration in these arrangements, but DOJ said the practice does not violate federal law. It can only be a matter of time before the supposed distinction between mutual promises (or the performance thereof) and the exchange of cash for a promise (or performance thereof) will crumble.

Friday, June 01, 2007

Health Lawyers News, June 1

From the folks at American Health Lawyers Association comes this week's issue of Health Lawyers News:

Top Stories

  • CMS Implements New Marketing, Education Requirements For PFFS Plans
    Abby L. Block Director of the Centers for Medicare and Medicaid Services’ (CMS’) Center for Beneficiary Choices sent a memo May 29 to Medicare Advantage (MA) Private fee-for-service (PFFS) plans reminding them that CMS is requiring new outreach processes to ensure beneficiaries and providers are informed about the distinctive features of Medicare PFFS plans. Full Story
  • Baucus, Grassley Urge IRS To Update Reporting Forms For Nonprofits
    Senate Finance Committee Chairman Max Baucus (D-MT) and Ranking Member Charles Grassley (R-IA) sent a letter May 25 to Treasury Secretary Henry Paulson urging him to update Form 990 and Form 990 PF that nonprofits file with the Internal Revenue Service (IRS) in order to gain greater transparency into the workings of tax-exempt organizations including charities. Full Story

Articles & Analyses

Current Topics


Table of Contents © AHLA, 2007. Reprinted by permission.

Thursday, May 31, 2007

NIH creates and confers new AID research awards

This is a little late in hitting the usually up-to-the-moment HealthLawBlog (!), but it's still worth noting. NIH has created the NIH World AIDS Day Awards to recognize truly brilliant, trail-blazing work by researchers and program managers whose contributions to AIDS research have probably saved the lives of millions. One of the recipients this past year was Bob Yarchoan (who, I am proud to say, was a college classmate of mine). Here's what the award citation said about Bob:

A joint award to Robert Yarchoan, M.D. and Hiroaki Mitsuya, M.D., Ph.D. of the National Cancer Institute — for their individual and combined achievements, groundbreaking discoveries and innovative and original scientific contributions that have significantly advanced HIV treatment research. Their landmark clinical studies, demonstrating that AZT could result in partial restoration of the immune response and temporary clinical benefit, established the first treatment for HIV infection and launched the era of effective therapy for HIV/AIDS. Their work significantly advanced this field, directly impacting on the development of new and better strategies to prevent and treat HIV disease in this country and around the world.

Congratulations, Bob!

Wednesday, May 30, 2007

China's ex-regulator of food and drug gets death penalty

And I thought we took food and drug regulation pretty seriously over here! This is from the AP (courtesy of The Boston Globe), and thanks for the tip to Peter Leibold, the EVP at American Health Lawyers Association:

China's former top drug regulator was sentenced to death Tuesday for taking bribes to approve untested medicines, as the country's main quality control agency announced its first recall system targeting unsafe food products.

The developments are among the most dramatic steps Beijing has publicly taken to address domestic and international alarm over shoddy and unsafe Chinese goods -- from pet food ingredients and toothpaste mixed with industrial chemicals to tainted antibiotics.

The Beijing No. 1 Intermediate People's Court convicted Zheng Xiaoyu for taking bribes in cash and gifts worth more than $832,000 when he was director of the State Food and Drug Administration, the official Xinhua News Agency said. The court then issued the death penalty, the report said.

Tuesday, May 29, 2007

Dutch reality tv: who will get my kidney?

According to AP this morning (courtesy of the Chicago Sun-Times), the BNN television network in The Netherlands plans to go forward with its reality program, "Big Donor Show," in which a terminally ill 37-year-old woman will interview and choose from among three transplant candidates. The network says they intend the show to serve as a public-service message about the number of Dutch patients (2,000) who die each year while waiting for a kidney transplant. Really? It's not about the cruel exploitation of desperate, dying people in order to boost ratings? Really? Really?

Monday, May 28, 2007

Emergency research protocols expand

It was controversial when the FDA amended its version of the Common Rule (21 CFR Part 50) in 1996 to add a provision that allows for emergency research when true informed consent isn't possible (§ 50.24) -- the first time human subjects could be legally enrolled in research without their consent. The FDA defended the move as a modest exception for the relatively rare instances in which research would be stymied because of the impossibility of obtaining consent that would otherwise be required. As an article in yesterday's Washington Post makes clear, such research is getting considerably less rare, renewing the decade-old debate about whether the FDA's exception is really needed or is encouraging, as BU's George Annas says, " lazy investigators not wanting to try to get informed consent in situations where it is difficult to get it, so they say it is impossible."


Department of full disclosure: I have been a member of a consultation group in Dallas in connection with the emergency research discussed in this article ("Clinical Trial of the Active Compression-Decompression (ACD) and Inspiratory Threshold Valve (ITV) Devices vs Standard CPR").

Saturday, March 31, 2007

California health reform

Ned Spurgeon (Utah and visiting distinguished chair at McGeorge this semester) has done a really nice piece on California health reform. It's been posted by Elizabeth Ann Weeks (Kansas) on the Jurisdynamics blog page.

Saturday, March 24, 2007

Living with an incurable genetic disease

The N.Y. Times ran a remarkable story last Sunday describing the life changes that occur when a person chooses to learn whether she has the genetic condition -- Huntington's Disease (or HD) -- that killed her grandfather and afflicts her cousin. Is it a good idea to find out, or is it an invitation for sorrow, stigmatization, and loss of insurability? The issues are explored sensitively and in detail in this article, which I didn't see last Sunday as I prepared for and gave a talk to The Institute for the Humanities at Salado on, of all things, medical privacy and the uses to which genetic information may be put. Thanks to college classmate Rick Goggans, M.D., for pointing this one out to me!

Links to HD resources (provided by The Times):

Fen-phen lawyers defrauded plaintiffs, court rules

Physicians, other health care professionals, hospitals, and other health-care entities take their lumps here with some regularity, so it is perhaps only fitting that I should note this story from yesterday's N.Y. Times:

W. L. Carter knew there was something fishy going on when he went to his lawyers’ office a few years ago to pick up his settlement check for the heart damage he had sustained from taking the diet drug combination fen-phen.

The check was, for starters, much smaller than he had expected. And his own lawyers threatened to retaliate against him if he ever told anyone, including his family, how much he had been paid. “You will be fined $100,000, you will go to jail and you will be sued,” Mr. Carter recalled them saying.

Mr. Carter was right to have been suspicious. The lawyers defrauded their clients, a state judge has ruled in a civil case, when they settled fen-phen lawsuits on behalf of 440 of them for $200 million but kept the bulk of the money for themselves. Legal experts said the fraud might be one of the biggest and most brazen in legal history.

This week, several clients testified before a federal grand jury that has begun to investigate potential criminal wrongdoing arising from the settlement.

“It enrages me,” said Sonja Pickett, a retail manager, who testified Thursday before the grand jury. “They robbed us.”. . .

The basic facts are not in dispute. When the clients sued the drug maker, they agreed to pay the lawyers 30 percent to 33 percent of any money that was recovered, plus expenses. In this case, that would have left the 440 clients to divide perhaps $135 million.

But the clients received only $74 million. An additional $20 million went to a questionable “charitable fund.” The rest — $106 million — went to lawyers. Though amounts of the individual settlements remain sealed, court papers suggest they were from $100,000 to $5 million. On average, plaintiffs received less than 40 percent of what the settlement agreement specified, instead of the roughly 70 percent to which they were entitled.

Had the lawyers merely taken what they were contractually entitled to, they would have become very rich men, said Tracy Curtis, a mortgage loan officer who is also suing her former lawyers. “They could have taken the high road,” Ms. Curtis said. “They would have made plenty of money.”

There's more, and it's all ugly. Shameful.

Federal bill prohibiting genetic discrimination analyzed by Congressional Budget Office

H.R. 493 (the "Genetic Information Nondiscrimination Act of 2007") would broadly prohibit genetic discrimination by employers (including states and their political subdivisions), unions, employment agencies, and insurers. It has 221 co-sponsors, which is more than enough (assuming they all vote for the bill in the form in which it hits the floor and after amendments, if any) to pass in the House. Here's the Congressional Research Service's summary of the bill:

  • Amends the Employee Retirement Income Security Act of 1974 (ERISA) and the Public Health Service Act to expand the prohibition against discrimination by group health plans and health insurance issuers in the group and individual markets on the basis of genetic information or services to prohibit: (1) enrollment and premium discrimination based on information about a request for or receipt of genetic services; and (2) requiring genetic testing. Sets forth penalties for violations.

  • Amends title XVIII (Medicare) of the Social Security Act to prohibit issuers of Medicare supplemental policies from discriminating on the basis of genetic information.

  • Extends medical privacy and confidentiality rules to the disclosure of genetic information.

  • Makes it an unlawful employment practice for an employer, employment agency, labor organization, or training program to discriminate against an individual or deprive such individual of employment opportunities because of genetic information. Prohibits the collection and disclosure of genetic information, with certain exceptions.

  • Establishes a Genetic Nondiscrimination Study Commission to review the developing science of genetics and advise Congress on the advisability of providing for a disparate impact cause of action under this Act.

For a more detailed discussion of the bill, go to H. Rept. 11-28 (Part I), March 5, 2007. Also, a number of states already have similar laws on their books. The National Conference of State Legislatures has a handy list of such laws (last updated Nov. 2006 (employment) and June 2005 (insurance)).

Yesterday, the CBO published its cost estimate for H.R. 493. Over 10 years, the federal treasury would be out about $2 million (because premiums for some of the new insureds would be tax-deductible) and the CBO estimates increased outlays of about $2 million (assuming appropriations are approved) for the Departments of Labor, Treasury, and HHS. There will be additional state and private-sector mandates in connection with the anti-discrimination law, but CBO figures the cost will be low for the states and below the threshold in the Unfunded Mandates Reform Act for the private-sector actors.

If there's a surprise in any of this, it might be in the estimated number of citizens expected to benefit from this law: 600. Is there any chance this is a typo?

Thursday, March 22, 2007

From CMS today (see new COP in Friday's Federal Register (I'll supply the link when it's available tomorrow)):



NEW MEDICARE HOSPITAL CONDITIONS OF
PARTICIPATION FOR TRANSPLANT CENTERS


The Centers for Medicare & Medicaid Services (CMS) issued a final rule today setting forth the requirements that transplant centers must meet to participate in the Medicare program that moves Medicare covered transplant programs toward an outcome-focused system.

This final rule will move Medicare-covered transplant programs toward an outcome-focused system that reflects the clinical experience, resources and commitment of the transplant program. The rule contains comprehensive conditions of participation for transplant programs serving Medicare beneficiaries.

It will ensure effective oversight of transplant centers by advancing coordination between CMS, State survey agencies, the Health Resources and Services Administration, the Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients.

“This is a major milestone in our efforts to make sure that people needing transplants get the best possible care, while giving transplant centers and physicians comprehensive and reliable guidance,” said Leslie V. Norwalk, CMS acting administrator. “This rule both improves the current transplant outcome measure requirements and strengthens the protection of the health and safety of patients and living donors.”

In recent decades, remarkable strides in transplantation technology and pharmacology have turned organ transplantation into a mainstream treatment for many patients in end stage organ failure. CMS issued coverage decisions related to heart transplants in 1987, liver transplants in 1991, lung transplants in 1995, and intestine transplants in 2001 and updated in 2006. Kidney transplant centers have been regulated in the Code of Federal Regulations since 1976. This rule will consolidate all transplant center requirements into one regulation.

All transplant centers that continue to participate in Medicare, including kidney transplant centers, are required to submit a request for initial approval. Once approved by Medicare, transplant centers are eligible for re-approval every 3 years.

Transplant centers with current Medicare approval, that have applied for initial approval within 180 days from the effective date of the final rule may continue to provide transplant services and receive payment from Medicare until CMS makes a decision on the transplant center’s request for approval.

The final rule went on public display today at the Office of the Federal Register for publication on Friday, March 23, 2007.

Tuesday, March 20, 2007

IRS releases "Good Governance Practices" for charitable organizations

I meant to post this earlier, but the posts have been few and far between this month, and Davis & Tremaine beat me to the punch, so I have to give them credit for this one: The IRS has announced the release of a staff discussion draft of "Good Governance Practices for 501(c)(3) Organizations." Major sections of the draft include these topics: Mission Statement, Code of Ethics, Due Diligence, Duty of Loyalty, Transparency, Fundraising Policy, Financial Audits, Compensation Practices, Document Retention Policy. It's about three (3) pages long and its content shouldn't surprise anyone with a passing familiarity with the law of exempt orgs.

The IRS seems to be saying that adoption of these good governance practices is not a criterion for obtaining or retaining exempt status, but that an organization that departs to a significant degree from them is more likely to engage in practices that put its exempt status in jeopardy. Interestingly, if somewhat bizarrely, the Service inserted a comment about board size into its introduction that doesn't appear -- either implicitly or explicitly -- in the Good Governance Practices themselves. It's the trite-but-true "Goldilocks" principle that boards that are too small have difficulty representing "a public interest" and boards that are too large "may be less attentive to oversight duties." Presumably boards that are "just right" are more likely to see that their duties are carried out in a manner that promotes, in the case of exempt hospitals, community benefits.

Monday, March 05, 2007

GAO testimony on DOD/VA care problems for injured soldiers, vets

GAO released the text of its testimony today before the Subcommittee on National Security and Foreign Affairs of the House Committee on Oversight and Government Reform. The witness list and links to testimony and related documents are here. What is fairly clearly emerging is a sense that the problems with outpatient care at Walter Reed Army Hospital -- described in a series of articles in The Washington Post last week -- are the tip of the iceberg. That's the gist of an article by Anne Hull and Dana Priest in today's Post.

It may be true, as Paul Krugman writes in today's op-ed (paid TimesSelect subscription required) in the N.Y. Times, that the worst of the worst in terms of quality care (or the lack thereof) is in the military hospitals, which are separate and distinct from the VA. And the VA may still be the exemplar of quality that it's been touted to be for the past 10 years (although that's not what I hear from the medical students who rotate through the VA hospital here, and that's not the message from vets in today's Post article by Hull and Priest). But the testimony of the GAO witness documents some of the ways that the care in the VA system breaks down when a patient is handed off from the military's hospital system to the VA's.

To be middle-class and uninsured

Robert Pear has an interesting front-page article today in the N.Y. Times ("Without Health Benefits, a Good Life Turns Fragile") on the growing phenomenon of employees and independent contractors whose arrangements don't include health insurance. The main focus is about a 50-year-old real-estate agent with Century 21, Vicki Readling, who makes about $60,000 but can't afford a health-insurance policy that is priced -- on account of her pre-existing diagnosis of cancer -- at $27,000:

[T]he uninsured are not necessarily the poor, the unemployed and the undocumented. Solidly middle-class people like Ms. Readling are one of the fastest growing subgroups.

And that is one reason, according to a recent New York Times/CBS News poll, that the problems of the uninsured have jumped to the top of the domestic political agenda in Washington and on the campaign trail.

Today, more than one-third of the uninsured — 17 million of the nearly 47 million — have family incomes of $40,000 or more, according to the Employee Benefit Research Institute, a nonpartisan organization. More than two-thirds of the uninsured are in households with at least one full-time worker.

The article offers a good illustration of the problems encountered by the uninsured.

To save money, Ms. Readling said, she defers visits to the doctor and stretches out her cancer medication, which costs her about $300 a month. She takes the tiny pills three or four times a week, rather than seven days a week as prescribed.

“I really try to stay away from the doctor because I am so scared of what everything will cost,” said Ms. Readling, who is divorced and has twin 18-year-old sons. Before every doctor’s visit and test, she asks, “How much are you going to charge me?” She says she tries to arrange “the best deals I can.”

But in many cases, the price is still unaffordable, and “I have to do without.”

Undertreatment and general mismanagement of chronic conditions will, in the long run, result in more expense, not less, but if short-term cash flow makes the cost of care prohibitively expensive, where's the safety net for patients like Ms. Readling? It doesn't exist.

Wednesday, February 28, 2007

Washington state courts publish public health emergency bench book

A number of jurisdictions have published bench guides for dealing with public health emergencies. The most recent of which I am aware comes from the courts in the state of Washington. Their Public Health Emergency Bench Book (HTML) (PDF) is a tidy little guide that provides a good checklist for any other court system considering what procedures are available during a public health emergency, as well as the practical considerations involved in providing justice when court personnel are missing or when sanitary conditions cannot be assured. Other bench books have been produced for the Indiana courts (updated July 2006) and Kentucky courts. Other jurisdictions have also prepared materials on courthouse preparedness (Google search).

NY Times article on the pervasive -- and perverse -- presence of IRBs on campus

Today's article is more about nonmedical research that is subject to IRB review and occasional veto, but it is interesting as a cultural marker that shows the spreading influence of the medical model of consent (and the growing pushback thereto).

Tuesday, February 27, 2007

Second Champaign hospital loses its exempt status

Health Business Policy has a news flash that the Champaign County (IL) "Board of Review reports that the Illinois Department of Revenue (“DOR”) has revoked the property tax exemption of a second hospital in Champaign-Urbana, the Carle Foundation Hospital in Champaign, Illinois, agreeing with the original recommendation filed by the Board of Review to the Illinois DOR in the spring of 2005." There's nothing on the DOR web site about the alleged affirmance.

The Board of Review's letter brief argued that the hospital was guilty of inurement by providing a practice platform for the for-profit physician group that operated it. Granted, this is the position of a single taxing authority (and maybe the state as well), but if that analysis is adopted widely, a lot of multi-specialty physician groups (at least the ones that aren't organized as nonprofits) with an affiliated health or hospital group are going to want to take a close look at whether they are organized and operated for a charitable purpose. Every entity's facts will be a little different, and exempt status is a "facts and circumstances" determination, but counsel for any such organization will want to pay close attention to the County's analysis of the inurement issue, as well as the other facts relied on in their brief.

Monday, February 26, 2007

Everything you always wanted to know about nanotechnology but were afraid to ask

Health lawyer Alan Goldberg alerted me to these nanotech-related publications from EPA:

If you're coming to the nanotech party a little late, a good place to start would be the federal government's National Nanotechnology Initiative:

The National Nanotechnology Initiative (NNI) is a federal R&D program established to coordinate the multiagency efforts in nanoscale science, engineering, and technology.

The goals of the NNI are to:

  • Maintain a world-class research and development program aimed at realizing the full potential of nanotechnology;
  • Facilitate transfer of new technologies into products for economic growth, jobs, and other public benefit;
  • Develop educational resources, a skilled workforce, and the supporting infrastructure and tools to advance nanotechnology; and,
  • Support responsible development of nanotechnology

Twenty-five federal agencies participate in the Initiative, 13 of which have an R&D budget for nanotechnology. Other Federal organizations contribute with studies,
applications of the results from those agencies performing R&D, and other collaborations. (See NNI Participants and NNI Structure and Strategies)

Monday, February 12, 2007

Lethal injection: what does the physicians' non-role portend?

Sunday's NY Times Magazine had an article by Elizabeth Weil on the boomlet of public and official opinion that is starting to cohere against the administration of the death penalty, in states that still have it, by lethal injection. Two articles in the past year by Atul Gawande (one in the New England Journal of Medicine and one in Nature) focus specifically on the role of physicians in such killings and are particularly worth reading.

AHLA's Health Lawyers Weekly (Feb. 9)

From the 9 February issue of AHLA's Health Lawyers Weekly:

Top Stories

Articles & Analyses

Current Topics

(c) 2007, reprinted with permission of AHLA