February 10, 2006
Public Health and Religion Clash Over Circumcision Rite
From this week's CDC Public Health Law News:
"Rare circumcision rite causes stir in N.Y."
Associated Press (02/02/06) David B. Caruso
In response to the death of an infant from herpes last year, the New York state Health Department is drawing up safety guidelines governing a controversial circumcision practice. The practice, performed by some Hasidic Jews, involves cleansing the wound by sucking blood from the cut. Doctors have long warned that the procedure could spread disease, including the herpes simplex type 1, which causes cold sores in adults but can be fatal to babies. Hasidic leaders have been reluctant to stop the practice because they say it is commanded by Jewish law. The Health Department is preparing voluntary guidelines to help reduce the chances of infection. According to Department spokesman Robert Kenny, rabbis will probably be asked to talk to their congregations about the risks of the procedure, and parents will be instructed to seek medical care for infants who develop a fever or rash. Mohels (pronounced MOY-il), traditional ordained practitioners of the procedure, could also be asked to police themselves by being aware of their health status before performing the ritual. Some doctors have argued that the potential for harm is substantial enough to justify an outright ban of the procedure. "This is something that is pretty much counter to all of the infection-control measures that we have," said Dr. Jonathan M. Zenilman. But Rabbi David Niederman argues that there is not enough information to justify the guidelines. "We are not fanatics," he said, "If there is evidence that this practice is not safe, we will not do it. We will be the first ones to act."
CBS News' report of the possible connection between the 2005 death and circumcision is here. WebMD reported in 2004 on a study by Israeli researchers of the risks. The report cited 8 cases of infection, one of which resulted in brain damage to the newborn. According to the report: "Researchers say that after the initial cases of herpes in circumcised infants were reported, the Chief Rabbinate of Israel pronounced in 2002 the legitimacy of using instrumental suction in cases in which there is a risk of infection. 'We support ritual circumcision but without oral metzitzah, which might endanger the newborns and is not part of the religious procedure,' write researcher Benjamin Gesundheit, MD, of Ben Gurion University in Israel, and colleagues."
February 9, 2006
This Judge Knows How Our Students Feel
U.S. District Judge Sam Crow, of Topeka, Kan., called Medicare regulations "complex, confusing and arguably incoherent at times" while sentencing three defendants who were found guilty of health care fraud, among other charges. Terence Cooper, Frank Heck and Paige Heck defrauded Medicare of more than $600,000 by billing for more expensive motorized wheelchairs and more expensive wheelchair seat cushions than were provided, the feds alleged.
Reprinted from the Feb. 6, 2006, issue of REPORT ON MEDICARE COMPLIANCE. [tm]
Cleveland Clinic Tightening Conflict-of-Interest Rules
Following a front-page story in the Wall Street Journal last year, the Cleveland Clinic has audited its conflict-of-interest practices (courtesy of a team from the Chicago office of McDermott Will & Emery) and announced its intent to tighten up. There's a good story in this morning's Plain Dealer and a longer version in the WJS (paid subscription required.) UPI has the nutshell version. [tm]
February 8, 2006
HIPAA Case Considers Law Enforcement Exception
Here's an interesting case via Vinson & Elkins' "Health Headlines":
In United States v. Zamora, a federal district court held that a subpoena signed by the clerk of the federal district court was not sufficient to compel a hospital to disclose a defendant's medical records without authorization. The government had served the hospital with the subpoena in connection with a criminal DWI case to obtain the results of a blood alcohol test performed on the date of the criminal incident. The court held that a subpoena signed by the clerk of a federal district court was insufficient to trigger HIPAA's law enforcement exception because the clerk was not a judicial officer for purposes of HIPAA. In addition, the court rejected the applicability of a federal statute requiring confidentiality of substance abuse records maintained in connection with a federally assisted drug and alcohol program, finding that participation in Medicare and Medicaid programs generally did not turn a hospital emergency room into a federally assisted program within the meaning of the statute and applicable regulations. Ultimately, the court issued a court order commanding the hospital to disclose the records on the grounds that the government had established probable cause justifying their production.
The opinion is available here: Zamora.pdf. [tm]
February 7, 2006
FDA's Leadership, Management Examined
From the Kaiser Family Foundation's Daily Health Policy Report:
- Baltimore Sun: The Sun on Saturday examined leadership at FDA, noting that the agency has "seen no fewer than four interim commissioners over all but 18 months of the Bush presidency." Most recently, the White House appointed Andrew Von Eschenbach to be acting FDA commissioner. The position has been led by acting commissioners for long periods under other presidents, the Sun reports. However, the lack of a permanent leader has "generat[ed] growing concern from members of Congress from both parties, various interest groups and industry," according to the Sun. A spokesperson for Rep. Mark Souder (R-Ind.) said a "continuous 'interim director' at FDA is like a baby sitter left in charge of the children indefinitely -- you don't want to leave important decisions to that person." Some former officials say that the lack of a permanent commissioner might "reflect the difficulty of finding someone acceptable to conservatives, industry and other interest groups," the Sun reports. Erin Healy, a spokesperson for the White House, said the Bush administration aims to nominate a permanent commissioner as soon as possible (Rockoff, Baltimore Sun, 2/4).
- Washington Post: FDA has reached its highest-ever backlog of generic applications, with more than 800 applications to bring new generic drugs to the market, the Post reports. The Office of Generic Drugs in December 2005 received an all-time monthly high of 129 applications, according to Gary Buehler, the office's director. Last year, the agency approved 450 applications, down 23 from 2004, and took an average of 20.5 months to review each application. The current law requires FDA to review applications within six months. Buehler said he expects a record number of generic drug applications in 2006, adding that he also anticipates a backlog because the office will not be receiving any staff increases. He said, "We are very aware that many, many people are waiting for more generics to be approved and that there is frustration about the backlog." Former FDA Commissioner Lester Crawford in testimony last summer before Congress said that the agency was approving an average of one generic drug application per day, saying that the "system seems to be working" and that the agency did not need additional staff members in the generics office. Rep. Henry Waxman (D-Calif.) said, "This huge backlog of generic applications is just unacceptable. This is the time for the FDA to be ramping up its generic reviews, not to be falling so badly behind" (Kaufman, Washington Post, 2/4).
More commentary from the fertile imaginations of the country's best political cartoonists:
- Signe Wilkinson (Phila. Daily News) on Alito, incrementalism, and Roe v. Wade
- Pat Oliphant (Universal Press Syndicate) on Alito and Roe
- Ben Sargent (Austin American-Statesman) on Medicare Part D
- Tony Auth (Phila. Inquirer) on Big Pharma and the seduction of your doctor
- Signe Wilkinson on Medicare Part D
- Mike Luckovich (Atlanta Journal-Constitution) on Medicare Part D
- Bob Gorrell (Creators Syndicate) on Medicare Part D
- Pat Oliphant on the Bush Administration's Medicare & Medicaid cuts
- Glenn McCoy (Universal Press Syndicate) on Medicare & complexity
February 6, 2006
AAP Backs Needle-Exchange Programs
From the AP (via The Washington Post):
Pediatricians should speak out in support of needle exchange programs to reduce the spread of HIV among injection drug users, the American Academy of Pediatrics says in a toughened policy statement.
Doctors also should discuss HIV risk with their teenage patients "with a nonjudgmental approach" and offer confidential help if local laws allow, the group says in the statement appearing Monday in the journal Pediatrics.
The full text of the new policy is here. [tm]
Sperm Donors and the Crumbling Wall of Anonymity
U.S. News & World Report has this article on-line: "Who's Your Daddy?" Of particular note:
Advances in the use of genetic medicine to predict and prevent disease, new DNA technology that makes it possible to trace ancestry, and the growing power of the Internet are galvanizing the donor community. In turn, they are challenging the limits of donor anonymity and upping the pressure on sperm banks to make information about biological dads available to donor children.
It is only a matter of time before the courts step in, say legal and ethical experts. "As advances in genetics continue to raise the question of health risks due to heredity, more people made in nontraditional ways will demand to know about their biological ancestors," says Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "I have no doubt that children's interests will dominate, and the courts will break down the walls of privacy just as they did in adoptions." Most states, for instance, now make birth certificates available to an adopted child if a court finds there is a good cause.
In several European countries, including Britain, Sweden, Norway, and the Netherlands, donor anonymity has already come to an end. It is illegal to sell anonymous donor sperm in those countries, and a few cases that would allow donor children access to birth records are making their way through the legal system. The same restrictions on the sale of donor sperm, which have been accompanied by a dramatic falloff in supply in Europe, are not expected in the United States anytime soon. However, the nation's biggest sperm banks are responding to the growing demand from would-be mothers for donors who are willing to identify themselves. Last month, the Fairfax Cryobank, one of the largest sperm banks in the country, began an ID Consent Donor program. Donors must be willing to be contacted, via the sperm bank, by their offspring at age 18. Donors also agree to provide yearly updates on their whereabouts for 18 years following their participation in the program.
February 5, 2006
Rob Schwartz Named Distingishing Visiting Bioethicist at SIU
Robert L. Schwartz, a 30-year UNM School of Law faculty member, has been named the 2006 Distinguished Visiting Bioethicist by Southern Illinois University School of Law’s Center for Health Law and Policy. Schwartz will present a talk “The Rules of Engagement in the Bioethics Debate: Lessons from the Terry Schiavo Case” Thursday, March 30 at the SIU School of Law.
The full press release is here. [tm]
Physicians' Class Action Against Pacificare Dismissed
As reported by Modern Healthcare's "Daily Digest" (Feb. 4):
A federal judge in Miami dismissed charges against PacifiCare Health Systems, Cypress, Calif., in a class-action racketeering lawsuit alleging that the nation's largest health insurers systematically shortchanged up to 900,000 physicians. U.S. District Judge Federico Moreno ruled in a summary judgment that there was no evidence that PacifiCare, which was acquired by UnitedHealth Group in December 2005, conspired with other insurers to underpay physicians or that it aided alleged violations of the Racketeer Influenced and Corrupt Organizations Act. "Indeed, some of the plaintiffs' recent descriptions of the alleged conspiracy are so general that they would include much legal conduct, such as innocuous efforts to reduce costs," Moreno wrote. "By definition ... managed-care systems seek to reduce costs in the delivery of medical care."
Physicians and medical associations sued 10 major publicly traded HMOs in 1999, alleging that the companies conspired to use computer software to delay, deny or reduce reimbursements. All but two of the insurers reached multimillion-dollar settlements out of court without admitting wrongdoing. The remaining defendants, UnitedHealth and Coventry Health Care, are scheduled to seek summary judgment before Moreno March 14. The trial in the case, delayed several times over the years, is scheduled for September.