HealthLawProf Blog

The Market for Cadaveric Tissue

AP (Yahoo) has a story about the poorly unregulated market in cadaveric tissue that will curdle your blood.  I am stunned that the FDA has done as poor a job of oversight as it has:

The federal agency responsible for tissue safety, the

Food and Drug Administration, is well aware of the problems. Yet, many experts believe the rules the FDA enacted last year as a long-promised overhaul fall short of providing the level of oversight needed.

Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses. Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses.

When it does inspect, public health isn't always protected. In 2003, an FDA inspector saw that Biomedical Tissue Services — the now-notorious New Jersey company — wasn't documenting what it did with tissue unsuitable for transplant. The FDA let the matter drop after the company sent a letter saying it had fixed the problem. For two more years, thousands of people received tissue.

"I'm not surprised that a BTS (incident) occurred. And there will be others," said Areta Kupchyk, a former FDA lawyer who drafted rules that ultimately were adopted in watered-down form. "We continue to be at risk."

In a related AP story, you can read more about the potholes that plague this industry. [tm]

New Twist on Unauthorized Practice of Medicine

This item is from the Federation of State Medical Board's newsletter [links added by me]:

The executive directors of the Texas and Mississippi medical boards testified on June 6 before a U.S. House subcommittee investigating public health issues in the wake of a court ruling that found medical screening companies and physicians were diagnosing patients with silicosis for the purpose of referring them to law firms as plaintiffs in mass tort litigation.

The House Energy and Commerce Oversight Subcommittee is investigating screening practices for silicosis, a lung disease caused by the inhalation of silica dust, which occurs during mining and other industrial processes. Subcommittee members criticized the practices of RTS, Inc., N&M Inc., and Occupational Diagnostics, which conducted the screenings addressed in the June 2005 U.S. District Court opinion In Re: Silica Products Liability Litigation, MDL Docket No. 1553 (S.D. Tex., June 30, 2005).

Donald Patrick, M.D., J.D., executive director of the Texas Medical Board, testified to the issue regarding unlicensed practice of medicine. In Texas, he said, making a diagnosis falls under the definition of practicing medicine. Physicians seeing patients for screening companies who made the diagnosis of silicosis in those patients were practicing without a license. In Texas, Dr. Patrick emphasized, such practice is a felony. Mallan Morgan, M.D., executive director of the Mississippi State Board of Medical Licensure, testified the screening companies were operating without permission from their states.

In her opinion, U.S. District Court Judge Janis Graham Jack noted that only 12 doctors were responsible for the silicosis diagnoses of more than 9,000 plaintiffs involved in the case, nearly all of whom the physicians neither met, treated nor physically examined.

Other hearing dates on this topic are March 31 and March 8.  [tm]

New CLIA Brochure Available

Some news from CMS (this looks pretty good) . . . .

The Clinical Laboratory Improvement Amendments (CLIA) brochure has been updated and is now available in downloadable format on the Medicare Learning Network’s (MLN) Products page located at   http://www.cms.hhs.gov/MLNProducts/downloads/CLIABrochure.pdf .

The brochure includes an overview of CLIA, why it is important, how test methods are categorized, enrollment information, as well as information regarding the five types of laboratory certificates.  A hard copy of the brochure will be available early this summer and will be available for ordering on the MLN Publications Page at http://www.cms.hhs.gov/MLNProducts/MPUB/list.asp .

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New Report on Universal Health Care Coverage

According to a recent interim report of the Citizens' Health Care Working Group,  a 14-member committee representing consumers, the disabled, business and labor, and health care providers, Americans believe that "all Americans should have a set of health coverage benefits guaranteed by law." Those benefits should be "portable and independent of health status, working status, age (and) income."  The Citizens' Health Care Working Group was created by Congress in late 2003 and funded with $5.5 million.  Beginning in February of last year, the group traveled to 50 communities and heard from 23,000 people.  The Group's interim recommendations may be found here.  According to the Associated Press:

The committee describes its recommendations as a framework. The recommendations don't say who would pay for universal health coverage or how much it would cost. The concept of government-guaranteed coverage runs counter to the Bush administration's position that consumers should bear more responsibility for their initial medical expenses.

The group's findings will be officially presented to the president and Congress in the fall, but first comes 90 days of public comment. The president will submit to Congress his response, and then five congressional committees will hold hearings.

Some organizations are already suspicious of the Group's recommendations:

"It implies massive new funding sources, massive new laws would be needed," said Sarah Berk, executive director of Health Care America, an advocacy group that pushes free market approaches to health coverage. "We want universal access, but this report just pushes all the difficult problems onto somebody else's plate. It says government needs to do it all."

George Grob, the executive director of the Citizens' Health Care Working Group, said the group was not asked to say specifically how to get to universal coverage. However, the group did recommend that financing strategies be based on principles of fairness and shared responsibility. The strategies should draw on revenue streams such as enrollee contributions, income taxes, so-called "sin taxes" and payroll taxes, the report said.

"We're already paying for health care for everybody who gets it, including people who don't have health insurance coverage who are taken care of when they go to the hospital," Grob said.

[bm]

FDA Approves Cervical Cancer Vaccine

Today, the FDA aproved the cervical cancer vaccine, Gardasil, for use in girls and women ages 9 to 26 (oops - I am out-of-luck).  The Associated Press reports,

The vaccine works by preventing infection by four of the dozens of strains of the human papillomavirus, or HPV, the most prevalent sexually transmitted disease.

By age 50, some 80 percent of women have been infected.

Gardasil protects against the two types of HPV responsible for about 70 percent of cervical cancer cases. The vaccine also blocks infection by two other strains responsible for 90 percent of genital wart cases. The vaccine will be available by the end of the month, with a three-shot series costing $360.

Its manufacturer, Merck & Co. Inc., seeks similar approval elsewhere around the world. Each year, cervical cancer kills an estimated 240,000 women worldwide, including 3,700 in the United States.

"FDA approval of the HPV vaccine, the first vaccine targeted specifically to preventing cancer, is one of the most important advances in women's health in recent years," said Dr. Carolyn Runowicz, president of the American Cancer Society.  The vaccine developed for hepatisis B has been shown to protect against liver cancer.

Clinical trials showed Gardasil prevented 100 percent of cervical cancer related to the two HPV strains in women who had not been previously infected, Merck said. It also prevented 99 percent of the cases of genital warts caused by the two other strains. . . . .

Gardasil works best when given to girls before they begin having sex and run the risk of HPV infection. The vaccine does not protect those already infected.

Of course, some controversy remains ---

The national Advisory Committee on Immunization Practices will decide June 29 whether to endorse routine vaccination with Gardasil. That endorsement is critical if a vaccine is to become a standard of care.

Sen. Frank Lautenberg, D-N.J., urged the panel to put "science and women's health ahead of ideological opposition" in considering a recommendation.

It then will be up to individual states to decide whether to add the vaccine to the list of others required before students may attend public schools.

Conservative groups like Focus on the Family support availability of the vaccine but oppose making it mandatory, saying the decision to vaccinate should rest with a child's parents or guardians. It promotes abstinence as the best way to prevent infection by HPV and other STDs.

Inda Blatch-Geib, an Akron, Ohio mother of four, said she'd consider vaccinating her daughters, ages 9 and 16. Blatch-Geib, 41, doesn't think it would signal a parental OK for her girls to have sex.

"Giving the vaccine goes with a conversation. We are pretty open with our children, so it wouldn't be an issue. It would lead to conversations," Blatch-Geib said.

The vaccine does not eliminate the need for regular Pap tests, which can detect precancerous lesions and early cancer. Merck has said Gardasil could cut the number of abnormal Pap results due to HPV infection. . . . .

The cost of Gardasil and the difficulty of getting young girls in to see a doctor three times in six months to receive the vaccine could pose problems, said Cynthia Dailard, senior public policy analyst at the Guttmacher Institute, which focuses on sexual and reproductive health. Ensuring its availability to poor and minority girls and women — and others less likely to receive regular Pap exams — also will be difficult. Merck plans to provide Gardasil for free to the poor and uninsured.

"This is an incredibly exciting breakthrough, but at the same time, it presents some major challenges, some the likes of which we have never confronted before," Dailard said.

[bm]

Just for Fun

I enjoy watching the Colbert Report.  I recently located this clip from the show containing a gravitas competition between Stone Phillips and Stephen Colbert.  The competition revolved around who could display the most gravitas when reading bizarre news headlines.  Well, there has been a re-match, so here is clip 2.  Thanks to the website onegoodmove for posting the videos.  I wonder if any of my students ever feel that they are forced to assume the gravitas tone exhibited in these clips when representing their clients. 

[bm]

Sperm Donor Issues

This week's New York Times Science section has an interesting article on some of the concerns raised by anonymous sperm donors.  The article reports,

Sperm donor No. F827 aced all the tests. He was healthy, and he said his parents and grandparents were, too. Under a microscope, his chromosomes looked perfect. He also turned out to be quite prolific: his deposits to a Michigan sperm bank during the 1990's produced 11 children.

   

But he passed a serious gene defect to five of those children, a blood disease that leaves them at risk for leukemia and in need of daily shots of an expensive drug to prevent infections. They also have a 50-50 chance of passing the disease to their children.

Shouldn't the sperm bank have detected the bad gene and rejected the donor?

Geneticists say no, because the disease is extremely rare and sperm banks cannot be expected to test for every possible mutation.

But that bit of uncertainty raises other questions. Should any donor produce so many children, when they will be scattered far and wide, making it harder to recognize a pattern of illness than it would be if they all lived under one roof? It's also worth asking whether damage could be limited by requiring sperm banks to keep track of donors' babies so that if one or more got sick, other families who had used the same donor could be warned, sale of the sperm stopped and the donor notified.

The Michigan case, described last month in The Journal of Pediatrics, could be a warning signal to sperm banks and their customers — or it could be just a fluke, such a weird set of circumstances that it has no bearing on anyone else. It's hard to tell for sure, because the buying and selling of sperm is an intensely private, largely unregulated business. A lot is not known, and many participants want it that way. . . . . . .

Still, sperm banking seems to have a good track record, at least as far as anybody can tell. Donors are tested repeatedly for H.I.V., hepatitis and other infections. As for genetic disorders, there have been few other published reports of problems traced back to donors. The known cases include a donor in California who passed on a hereditary kidney disease and one in the Netherlands who fathered 18 children and was later found to have a serious neurological disease that his offspring have a 50-50 chance of inheriting.

The Food and Drug Administration has tissue-banking rules that apply to sperm banks, but those rules concern infectious diseases rather than genetics, and do not limit the number of pregnancies per donor or require tracking of the children's health. A trade group, the American Association of Tissue Banks, accredits sperm banks that meet its standards, but few banks participate in the program.

The Michigan cases came to light only because all four families with sick children happened to consult the same specialist at the University of Michigan, Dr. Laurence A. Boxer. The disorder, severe congenital neutropenia, is so rare — it affects only one child in five million — that when Dr. Boxer suddenly saw several cases in one year he suspected that something strange was going on.

Although the tone of the entire article appears to be quite positive about the safety of sperm banks, some greater regulations may be necessary in the future.   The lack of information and tracking seems to create a potential for future problems.  [bm]

Suits Seek Recoupment of Medicare Funds

As reported by Kaiser Family Foundation's Daily Health Policy Report:

     Two law firms have filed lawsuits in multiple states over allegations that a number of hospitals have improperly billed Medicare for treatment of injuries or illnesses caused by medical errors, the Los Angeles Times reports. According to the Times, the lawsuits, which "could potentially win millions of dollars," do not involve specific allegations of wrongdoing "but seek instead to find evidence of such treatments, arguing that Medicare should be reimbursed" (Yi, Los Angeles Times, 6/7). Florida-based law firm Wilkes & McHugh has filed such lawsuits in U.S. District Court in Arkansas against Colorado-based Catholic Health Initiatives, Texas-based Triad Hospitals and their malpractice insurers. The lawsuit alleges that the companies "breached their duties to Medicare" when they accepted "millions of dollars in payments" for treatment of injuries or illnesses caused by medical errors (Baskin, Arkansas Democrat-Gazette, 6/7). Wilkes & McHugh also has filed such lawsuits in California, New Jersey and Florida. The California lawsuits, filed on Friday in Los Angeles County Superior Court, name Adventist Health, County Villa Service, Catholic Healthcare West, Kindred Healthcare, Longwood Management, Mariner Health Care and Tenet California as defendants.

Comments
Tenet California spokesperson David Langness said, "These are the kinds of baseless lawsuits that contribute to the high cost of health care today" (Los Angeles Times, 6/7). Attorneys at Wilkes & McHugh offices in Florida and Arkansas declined to comment on the lawsuits. A spokesperson for CMS, which is not involved in the lawsuits, also declined to comment. However, CMS Administrator Mark McClellan last month said that Medicare should not have to reimburse hospitals for treatment of injuries or illnesses caused by 27 categories of medical errors. In addition, CMS last month in a statement said that Medicare reimbursements to hospitals for treatment of infections will decrease in October 2007, with additional reductions in reimbursements for treatment of injuries or illnesses caused by medical errors likely in the future (Arkansas Democrat-Gazette, 6/7).

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A Shortage of Doctors"

Ezra Klein has an excellent post on a recent LA Times story entitled, "Needs of Patients Outpace Doctors."  The article reports,

Twelve states — including California, Texas and Florida — report some physician shortages now or expect them within a few years. Across the country, patients are experiencing or soon will face shortages in at least a dozen physician specialties, including cardiology, radiology, and several pediatric and surgical subspecialties.

The shortages are putting pressure on medical schools to boost enrollment, and on lawmakers to lift a cap on funding for physician training and to ease limits on immigration of foreign physicians, who already constitute 25% of the white-coated workforce.

But it may be too late to head off havoc for at least the next decade, experts say, given the long lead time to train surgeons and other specialists.

"People are waiting weeks for appointments; emergency departments have lines out the door," said Phil Miller, a spokesman for Merritt, Hawkins & Associates, a national physician search firm. "Doctors are working longer hours than they want. They are having a hard time taking vacations, a hard time getting their patients in to specialists."

North Hollywood resident Anneliese Ohler, who had a cancerous lesion removed from her face several years ago, had to wait two months recently to see a dermatologist after her hairdresser — and then her primary doctor — told her they saw worrisome spots on the top of her head.

"I was lucky it was not cancer," said Ohler, 83. "But what if it had been?"

Experts say her wait was a symptom of a wider problem: Demand for doctors is accelerating more rapidly than supply.

The article continues and provides some reasons for the shortage of physicians.  Should be interesting to see if anyone involved in public policy decides to address this issue.  Hopefully someone will take note.  [bm]

No Plan B?

On Sunday the Washington Post ran an article witten by a woman concerning her recent experience in attempting and failing to obtain Plan B.  Dana L. writes:

I am a 42-year-old happily married mother of two elementary-schoolers. My husband and I both work, and like many couples, we're starved for time together. One Thursday evening this past March, we managed to snag some rare couple time and, in a sudden rush of passion, I failed to insert my diaphragm.

The next morning, after getting my kids off to school, I called my ob/gyn to get a prescription for Plan B, the emergency contraceptive pill that can prevent a pregnancy -- but only if taken within 72 hours of intercourse. As we're both in our forties, my husband and I had considered our family complete, and we weren't planning to have another child, which is why, as a rule, we use contraception. I wanted to make sure that our momentary lapse didn't result in a pregnancy.

The receptionist, however, informed me that my doctor did not prescribe Plan B. No reason given. Neither did my internist. The midwifery practice I had used could prescribe it, but not over the phone, and there were no more open appointments for the day. The weekend -- and the end of the 72-hour window -- was approaching.

But I needed to meet my kids' school bus and, as I was pretty much out of options -- short of soliciting random Virginia doctors out of the phone book -- I figured I'd take my chances and hope for the best. After all, I'm 42. Isn't it likely my eggs are overripe, anyway? I thought so, especially since my best friend from college has been experiencing agonizing infertility problems at this age.

Weeks later, the two drugstore pregnancy tests I took told a different story. Positive. I couldn't believe it.

I'm still in good health, but unlike the last time I was pregnant, nearly a decade ago, I'm now taking three medications. One of them, for high cholesterol, is in the Food and Drug Administration's Pregnancy Category X -- meaning it's a drug you shouldn't take if you're expecting or even planning to get pregnant. I worried because the odds of having a high-risk pregnancy or a baby born with serious health issues rise significantly after age 40. And I thought of the emotional upheavals that an unplanned pregnancy would cause our family. My husband and I are involved in all aspects of our children's lives, but even so, we feel we don't get enough time to spend with them as it is.

I felt sick. Although I've always been in favor of abortion rights, this was a choice I had hoped never to have to make myself. When I realized the seriousness of my predicament, I became angry. I knew that Plan B, which could have prevented it, was supposed to have been available over the counter by now. But I also remembered hearing that conservative politics have held up its approval.

My anger propelled me to get to the bottom of the story. It turns out that in December 2003, an FDA advisory committee, whose suggestions the agency usually follows, recommended that the drug be made available over the counter, or without a prescription. Nonetheless, in May 2004, the FDA top brass overruled the advisory panel and gave the thumbs-down to over-the-counter sales of Plan B, requesting more data on how girls younger than 16 could use it safely without a doctor's supervision.

Apparently, one of the concerns is that ready availability of Plan B could lead teenage girls to have premarital sex. Yet this concern -- valid or not -- wound up penalizing an over-the-hill married woman for having sex with her husband. Talk about the law of unintended consequences. . . . .

Unfortunately her story gets worse as she has additional problems locating a doctor who will perform an abortion for her.   Thanks to pandagon for the cite. [bm]

 

More Access to Mental Health

The KaiserNetwork.Org has a new video (also available as a podcast or transcript) entitled, 'Mental Health  Care," which  has several experts discussing access and financing of mental health care in the United States.  The program overview follows:

A significant number of people suffering from mental disorders in the United States do not receive the treatment they need. Join "Ask the Experts" to discuss the financing and delivery of mental health care in the U.S.

Moderator:

• Jill Braden Balderas, managing editor, kaisernetwork.org

Panelists:

• Mike Fitzpatrick, MSW, executive director, National Alliance on Mental Illness
• Richard Frank, Ph.D., Margaret T. Morris professor of Health Economics, Department of Health Care Policy, Harvard Medical School
• A. Kathryn Power, M.Ed., director, Center for Mental Health Services, Substance Abuse and Mental Health Services Administration

The website also contains some helpful links containing more helpful information on this topic.  [bm]

 

Access to Mental Health Care

This post on Daily Kos by an attorney who could not obtain the necessary medical care for his bipolar disorder is an eye-opening reminder of how our health care system needs to be reformed.  The fact that he had to leave the country to receive the necessary care is disheartening to say the least.  Here is a brief excerpt:

When I started working as a lawyer, I hoped my access to healthcare would improve, but it didn't.  It actually got worse.  My employer's insurance did not cover psychiatric care, so I went to state-sponsored clinic.  We met twice a week and since I couldn't afford the medication he prescribed, he sometimes provided manufacturer's samples.  But just when my therapy was succeeding and I had spent months without wanting to kill myself, and had even passed the bar exam, the psychiatrist said I seemed healthy and didn't need his help anymore.  . . . .

I was hired by a reputable national organization and quickly promoted and moved to a new state, where I had intense new responsibilities and no established psychiatric care.  I quickly became overwhelmed, so I discreetly inquired as to our company's health insurance benefits.  And that's when my health insurance nightmare began again in earnest. 

The employer had an HMO with severely limited number of providers who were listed in no particular order in a large telephone book.  They literally just handed me this phone book when I told them I needed psychiatric care.

When I independently contacted the professionals to whom I was referred by friends and specialists, the answer was always the same:  "I don't deal with HMOs; they're too much trouble and they pay too slowly." Psychiatrists charged $100.00 per hour, so I knew couldn't afford the two visits per week I needed to work successfully.

Ironically, while at work, I supervised a budget of over $12,000,000, with hundreds of clients and a dozen employees, yet after work hours I was medically destitute.  I took calls from the New York Times and appeared on cable news by day, while at night I went to Home Depot for a rope to hang myself. 

Still, I couldn't pay for good psychiatric help and my employer's HMO refused to pay.  When they finally referred me to a psychiatric management agency, I believed I would be meeting with a psychiatrist who could evaluate my immediate need for medication.  I was suicidal. 

But after two meetings, I became suspicious of this "doctor" and insisted on knowing the therapist's credentials. Only then did I discover that he was not a medical doctor at all and could not prescribe medication at all.  He was just a gatekeeper for the medical establishment, trying to dissuade me from getting treatment in order to save money for the HMO.  He had no intention of referring me to a psychiatrist.  . . .

Soon, I lost my job and spent the rest of my savings on $100.00 per visit psychiatric visits and medication.  My student loans fell into default.  When my money ran out and the therapy visits stopped, I alternated between hiding in my house and driving on the expressway at 105 miles per hour in the breakdown lane.  (I well remember my velocity because it was the maximum my new Honda would do while traveling downhill.)   . . . .

With all other avenues seeming closed to me, I decided to move - to France.  I reasoned that if my mind could do nothing else successfully, at least I could learn another language, for all the good that might do.  I applied for a passport and began to study French. . . .

To live in France, I would need a visa status.  So, although I had never taken a course in French and I spoke no French at all, I applied for a student visa and enrolled in a French doctoral program for international law.  What better way to immerse myself in French culture?  Plus, enrolling in a doctoral program helped me to explain leaving my latest lawyer position after only two months on the job.   

Surprisingly, the move made an immensely positive difference in terms of my access to medical care.  Even as a foreign student, for just two hundred dollars I was able to enroll for a year in the French national health care system.  How very ironic it was to receive medical treatment overseas for free that I could not obtain in the US even as working attorney.

Although I had been denied Medicaid in the United States after I lost my job, I had a French Carte Vital within a month.  This universal health card assured that doctors, hospitals and pharmacies nationwide would provide me the help I needed.  (Except, ironically, the American Hospital in Paris, which doesn't accept government reimbursements.) 

In France, I was finally diagnosed as manic depressive, bipolar.  In France, medical diseases that are particularly severe are covered for all necessary treatments at all hospitals and with no co-payments. Since manic depression is defined by the government as a "particularly serious disorder", all of my associated costs were covered 100%.  In France.

My psychiatrist treated me twice weekly without ever asking me for payment.  We tried a number of medications without the fear that the one I most needed might be beyond my financial means.   I tried lithium for the first time, but it didn't work for me.  Still, I felt much less desperate knowing that I would always be financially able to see my psychiatrist and take the medications he prescribed. 

The most difficult part of fleeing to France was foregoing the practice of law.  I wanted so desperately to live the middle-class ethos of consistent work and respectability.  Yet I finally accepted that pretending to be sane was more work that I was able to do.  Although I had managed to render service to my clients and make a professional mark, yet the emotional burden was more than I could continue to carry.

Because of effective and consistent treatment or for whatever reason, I never had a car accident in France and never received a speeding ticket.  But, as the war in Iraq drove up the US deficit and drove down the value of the dollar, I found I couldn't afford to live in France anymore.  I couldn't work and I sometimes had no food to eat beyond a croissant and a glass of orange juice.  I found myself living in poverty, unable to pay even my most pressing bills.  The desperation and anger came back and I didn't know what to do.

I came back to the United States and tried to apply for Medicaid, but after submitting ten times as much paperwork as had been required for success in France, I was rejected in the US as having too much income, even though I was living at the poverty line.

Today, I've made what peace with all of this that I can make.  I live in one of those third world countries where the dollar goes further. Although there is no national health care here, the very same medications that cost $200.00 per month in the United States are available here for just $30.00 dollars per month, which is seven times less.  . . .

The entire article is worth a read.  [bm]

Medicaid and Immigration

As reported by Robert Pear in this morning's NY Times:

The Bush administration plans this week to issue strict standards requiring more than 50 million low-income people on Medicaid to prove they are United States citizens by showing passports or birth certificates and a limited number of other documents.

The new standards follow a tussle with Congress. Federal health officials had considered giving states broad discretion to accept affidavits in place of official documents. But House Republicans complained, and the administration backed off, allowing affidavits "only in rare circumstances."

The requirements, which take effect July 1, carry out a law signed by President Bush on Feb. 8 [Public Law No. 109-171, § 6037].

They vividly illustrate how concern about illegal immigration is affecting domestic social welfare policy. The purpose of the law was to conserve federal money for citizens, reducing the need for states to cut Medicaid benefits or limit eligibility.

The article repeats concerns that the new standards will be a hardship (and possible loss of benefits) "children, older Americans and poor people born at home in rural areas who never received birth certificates."  What the article does not say, however, is that hospitals will continue to be caught between a rock and a hard spot. 

Federal policy may be to deny health care benefits to undocumented immigrants, but it obviously doesn't go so far as to require (or even permit) the denial of health care services (emergency services, at any rate) to undocument immigrants. EMTALA requires Medicare-certified hospitals to provide a medically appropriate screening for patients who come to their ER's and to attempt to stabilize any emergency condition found to exist, and this requirement applies (as it should) regardless of the patient's citizenship status. Tightening up Medicaid eligibility rules may (or may not) make some kind sense as a matter of immigration policy, but as a health care policy it only makes a bad situation worse -- and not only for hospitals.  Eventually, everyone pays for unreimbursed care.  It's a tax that takes many forms, from higher charges for patients who can pay (though the days of free-wheeling cross-subsidization have been long gone) to the closing of emergency rooms by hospitals that can no longer afford their EMTALA obligation. (Last year Congress appropriated a few billion dollars to provide some relief for hospitals in states that have experienced a high incidence of illegal immigration, but it's a drop in the bucket.)   We need a sensible solution to this problem, not one that punishes immigrants (and their families) and providers.  [tm]

Wake Forest Symposium: "Rethinking Health Law"

Mark Hall, Carl Schneider, and Lois Shepherd have co-edited a dynamite law review symposium on the future of health law.  The articles are collected at 41 Wake Forest L. Rev., No. 2 (Summer 2006) and are available here.  Here are the titles (with PDF links) and authors:

• Introduction
  Mark A. Hall, Carl E. Schneider, and Lois Shepherd
• The History and Future of Health Care Law: An Essentialist View
  Mark A. Hall
• Can Health Law Become a Coherent Field of Law?
  Einer R. Elhauge
• Some Thoughts on Academic Health Law
  Henry T. Greely
• After Autonomy
  Carl E. Schneider
• Assuming Responsibility
  Lois Shepherd
• Responsibility in Health Care: Spanning the Boundary between Law and Medicine
  Carol A. Heimer
• The Process Paradigm: Rethinking Medical Malpractice
  Roger B. Dworkin
• Our Broken Health Care System and How to Fix It: An Essay on Health Law and Policy
  Timothy Stoltzfus Jost

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HIPAA Privacy Rule: Toothless Tiger?

For all the hand-wringing about HIPAA, much of it reportedly fueled by the possibility of criminal penalties and draconian civil fines, today's Washington Post reports that punishments have been few and far between:

In the three years since Americans gained federal protection for their private medical information, the Bush administration has received thousands of complaints alleging violations but has not imposed a single civil fine and has prosecuted just two criminal cases.

Of the 19,420 grievances lodged so far, the most common allegations have been that personal medical details were wrongly revealed, information was poorly protected, more details were disclosed than necessary, proper authorization was not obtained or patients were frustrated getting their own records.

The government has "closed" more than 73 percent of the cases -- more than 14,000 -- either ruling that there was no violation, or allowing health plans, hospitals, doctors' offices or other entities simply to promise to fix whatever they had done wrong, escaping any penalty.

As the article says, this approach to enforcement by HHS's Office for Civil Rights pleases the health care industry but has privacy hawks up in arms. [tm]

Organ Donation

The University of Chicago Law School Faculty blog has an interesting post on organ donation and the current UNOS system.  The post by Professor Epstein states,

The centerpiece of the United States organ policy is a flat prohibition against the use of “valuable consideration” to purchase a live or cadaveric organ. One obvious consequence of this (indefensible) decision is the creation of chronic organ shortages that result in the death of thousands of individuals per year. As happens in all other markets where prices are capped or exchanges are prohibited, queues form. The money that would have been a simple transfer payment between buyer and seller can no longer be paid. Instead, frustrated buyers invest in time by waiting in line for the goods or services that they so desperately need. The upshot is that the buyers have to pay in time, not cash. But their outlays in time are deadweight losses, not simple transfer payments. Organs are no exception to the general behavioral response to maximum prices, here set at zero.

The queues themselves are, however, not stable because people at back of the queue are desperate to get to the front. In dealing with gasoline queues, they could easily arrange to make a side payment to take the place of some lower demander who has obtained a preferred place on the queue. Swaps of this sort are not possible with organ donations, because the list for cadaveric kidneys is tightly controlled by the United Network of Organ Sharing (UNOS), which has received a federal statutory monopoly to run the organ transplant system. So other efforts take place to beat the queue. If purchases of organs are not allowed, then individuals will advertise privately in order to persuade someone to make an organ gift. That gift is almost always a kidney. The risks to an organ donor of a kidney transplant are quite low (but by no means zero), and the palpable gains on the other side are the extension of life and liberation from the tyranny and pain of dialysis.

There is, however, at present resistance to individuals making end runs around the queue. As Sally Satel reported in the May 29th issue of the Weekly Standard, (http://sallysatelmd.com/html/a-ws5.html) the guardians at the gate include transplant surgeons who have one-upped UNOS taken the position that they will not perform even legal kidney transplants if the organ gift comes from a stranger and not a family member or friend. As Satel reports, Dr. Douglas Hanto, head of transplant surgery at Beth Israel Hospital uses the collective “we” to state “We are in favor of donors coming forward and donating to the next person on the waiting list. ”

As a defender of institutional autonomy, I would be the last person the right to challenge Dr. Hanto’s right to steer whatever course on organ transplant that he chooses. But by the same token, that principle of institutional of institutional autonomy does not, and should not, insulate him from the savage criticism that Satel and others have launched in his direction. The most obvious criticism is that he endorses the suicidal position that will result in practice in kill all live donations to strangers. As such it contravenes the fundamental principle of charitable conduct, which treats charity as an “imperfect” obligation. Society may, by moral suasion, insist that individuals who are well off give charity to someone. Because that obligation is imperfect, no legal compulsion may be used to seek compliance. Nor does any particular individual have any claim right to some charitable contribution from any particular donor. The matches are purely voluntary. If therefore one person wishes to go beyond the call of duty and give to a stranger, the charitable duty is meet, and indeed exceeded. We all should be grateful for the gift, and not carp that it is not given to someone else first.

There is, moreover, a more systematic objection to Dr. Hanto’s ill-advised position that also needs elucidation. Why do we imbue the UNOS transplant list with any legitimacy at all? That list itself is not the result of any deep moral principle, but represents the only workable compromise that a statist organization like UNOS is able to put into effect. As a matter of first principle, one sensible test for the allocation of organs in a nonmarket setting is to place them where they are likely to do the most good. That question in turn resolves itself into two different issues. The first is how much benefit with the organ provide to its recipient, measured the number and quality of life-years obtained. Next there is a moral dimension: which individuals do we wish to help and why? . . . .

Many years ago, the late George Stigler wrote that on all important questions of public policy, matters of allocation—here getting more organs—would “swamp” matters of distribution—here who gets which organ. He is surely right: first and foremost we need to do anything to increase the supply, here subject to the unwise external prohibition against organ sales.

Viewed in this light, the UNOS list—albeit one filled with hidden minefields—is a technocrat’s contrivance that is necessary to avoid the pitfalls of collective choice that do not haunt individual owners. It has zero intrinsic moral worth. Dr. Hanto has it exactly backwards. Any decision that circumvents the UNOS list for individual judgment should be welcomed for its moral seriousness. How tragic it would be if the rigidities of collective choice remain impervious to correction by the generous acts of strangers. Sally Satel is right to ask why mainstream medical ethicists have such a high tolerance for gratuitous cruelty. I wish I knew the answer to that one.

Posted by RAEpstein.  The  entire piece is a great read and comments to the post are also quite interesting and informative. [bm]

Do Terminally Ill Patients Have a Fundamental Right to Get Access to Post-Phase I Drugs?

A divided panel of the U.S. Court of Appeals for the D.C. Circuit answered that question in the affirmative last month in the potentially significant case of Abigail Alliance for Better Access to Developmental Drugs et al. v. von Eschenbach.  The plaintiffs (including the Washington Legal Foundation) had sued the FDA to establish the constitutional right of dying patients to obtain investigational drugs without relying upon the two versions of "compassionate use" currently allowed by statute ("single-patient INDs" and "treatment INDs"; see 21 U.S.C. § 360bbb(b) & (c)).  After the District Court dismissed their case, the D.C. Circuit reversed.  The opinion by Judge Judith Rogers (and joined by Chief Judge Douglas Ginsburg) concluded that previous Supreme Court cases support the plaintiffs' allegation that the right of terminally ill patients to obtain access to investigational drugs implicates a fundamental due process right.  Here is the court's summary:

First, the right at issue, carefully described, is the right of a mentally competent, terminally ill adult patient to access potentially life-saving post-Phase I investigational new drugs, upon a doctor’s advice, even where that medication carries risks for the patient. Second, we find, upon examining “our Nation’s history, legal traditions, and practices,” Glucksberg, 521 U.S. at 710, that the government has not blocked access to new drugs throughout the greater part of our Nation’s history. Only in recent years has the government injected itself into consideration of the effectiveness of new drugs. Third, Supreme Court precedent on liberty indicates that the right claimed by the Alliance can be inferred from the Court’s conclusion in Cruzan v. Director, Missouri Department of Health, 497 U.S. 261, 278 (1990), that an individual has a due process right to refuse life-sustaining medical treatment, id. at 279. Here, the claim implicates a similar right — the right to access potentially life-sustaining medication where there are no alternative government-approved treatment options. In both instances, the key is the patient’s right to make the decision about her life free from government interference.

The case goes back to the District Court now so that the court can make findings in light of the strict-scrutiny test that the Court of Appeals said applies to the case.  It's not at all clear that the FDA will be able to prevail under this tougher test.  For an excellent guide to the decision, the underlying law, and the implications of the D.C. Circuit's decision for the future of clinical drug trials, the food-and-drug lawyers at Covington & Burling have prepared the best summary I've seen.  [tm]