HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Monday, December 13, 2004

New HHS Secretary Nominated

President Bush today selected Mike Leavitt, the current EPA Chief, to be the new Secretary of Health and Human Services.   In making his selection, President Bush said that Leavitt is "fine executive" and "a man of great compassion," and he further lauded Leavitt explaining that "He's an ideal choice to lead one of the largest departments of the United States government."

Leavitt stated, "I look forward … to the implementation of the Medicare prescription drug program in 2006, medical liability reform and finding ways to reduce the cost of health care," Leavitt further said. "I am persuaded that we can use technology and innovation to meet our most noble aspirations and not compromise our other values that we hold so dear."

Many in the media has reported that Dr. Mark McClellan, the administrator of the Centers for Medicare and Medicaid Services, had the inside track for the HHS job, White House officials and many health care analysts said.   However, Dr. McClellan is overseeing the new Medicare prescription drug law, which takes full effect in 2006, and Bush was said to have been reluctant to take McClellan from his post during this critical period.

For more information on Mike Leavitt, see for a general biography and the LATimes and CNN for further information on the announcement.  National Public Radio had a long discussion about Leavitt on their evening "All Things Considered" program tonight.  They also detailed some of the problems that he may have in receving Senate confirmation. 

December 13, 2004 | Permalink | Comments (0)

Patient Health Data Inadvertently Shared With Public

As reported in last Friday's edition of the Sacramento Bee, "[n]early 200 patients at UC Davis Medical Center had private medical information made public last weekend after answers to an online customer satisfaction survey were accidentally shared with other respondents."  The article continues:

Patients who use the Internet to schedule appointments, refill prescriptions and contact physicians were asked in the survey to provide zip code, e-mail address, age and gender. Among other things, the survey asked how many prescriptions patients fill and whether they had a chronic medical condition.

By mistake, the survey also had a link that patients could click to see complete survey responses from others who'd filled out the questionnaire.

The computer glitch was quickly caught and fixed. But medical privacy experts at UC Davis and elsewhere said Thursday that the inadvertent disclosure of medical information violated the spirit, if not the letter, of state and federal patient privacy laws.

December 13, 2004 | Permalink | Comments (0)

Mental Health and Foster Care: Virginia Report

A report commissioned by the Virginia General Assembly contends that one in four children in foster care in that state are there because foster care is the only setting in which the children can get needed mental health care, according to a report in the Nov. 29 Washington Post:

The study -- the result of a months-long examination of the state's foster care and mental health services -- chronicles the difficult decisions that thousands of Virginia parents have made to relinquish custody of their children to the foster care system so they can get mental health services that are otherwise unavailable or unaffordable.

Many of these parents have children who suffer from schizophrenia, severe depression or bipolar disorder. The cost of caring for these severe conditions is so high that private insurers and HMOs don't fully cover it, and in many cases, the families make too much money to be eligible for Medicaid.

But because children can get those services if they are in foster care or in special education programs, parents turn to the child welfare system, which can provide day treatment, residential care and other expensive services.

"The main problem is that there is inadequate access to mental health treatment . . . and it tends to be extremely expensive if parents are able to receive it," said Raymond R. Ratke, deputy commissioner of the state's Department of Mental Health, Mental Retardation and Substance Abuse Services, who led the work group that published the report.

A syndicated column (courtesy of the Seattle Post-Intelligencer) by Bonnie Erbe appeared this week and focused attention on this largely-overlooked report.  She concluded:

Sen. Susan Collins, R-Maine, introduced a bill that has languished in Congress for several years called the Keeping Families Together Act. Its purpose is to prevent birth families from forfeiting custody just so the child can receive mental health care. The bill would pay the states to network state child welfare, juvenile justice and mental health agencies (so they communicate better) and to expand eligibility for Medicaid's "home and community-based services waiver" to children and adolescents in residential treatment facilities (so they can remain in the custody of their parents). . . .

As a nation we spent $1.7 billion on this year's presidential campaign (for ads, strategists, get-out-the-vote efforts and so on). We're predicted to spend $500 million on cell phone ring tones and graphics next year (a huge sum for a trivial pursuit). We're affluent enough to prevent the financial catastrophe of losing a mentally ill child to foster care when that child could just as easily have received those services while living at home. Now let's act like it.

The report, "The Relinquishment of Custody for the Purpose of Accessing Behavioral Health Treatment (House Document 34)" is here (PDF).

December 13, 2004 | Permalink | Comments (0)

Public Health Issue: Steroids and Kids

That's the cover story of the Dec. 20th issue of Newsweek, on sale today.  As reported by Yahoo!Finance,

A Newsweek analysis of the data from the annual "Monitoring the Future" survey by the University of Michigan's Institute for Social Research found that more than 300,000 students between the eighth and 12th grades used steroids in 2003. And, as Newsweek reports in the current issue, they were not all jocks; as many as one third were girls, and experts say there is a growing problem of steroid use by boys whose heroes aren't baseball sluggers but the sinewy, rock-jawed models glowering from the pages of the Abercrombie & Fitch catalog. This development led to the introduction of a new psychological diagnosis, muscle dysmorphia (sometimes called "reverse anorexia").

The survey suggests that the rate of steroid use by high-school students increased throughout the 1990s before dropping off slightly in 2003. An authority on youth sports, Dr. Jordan D. Metzl of the Hospital for Special Surgery in New York, calls steroid use "a burgeoning epidemic."

The University of Michigan study also found that the proportion of high-school seniors who consider steroids a "great risk" to their health actually dropped from 68 to 55 percent over the past five years. And Newsweek also reports that in talking to young athletes who did take steroids, it's striking how little notice their parents and coaches took of the changes taking shape before their eyes. "Coaches are oblivious to it," says California state Sen. Jackie Speier, who sponsored a bill to crack down on sales of dangerous supplements to minors, "some out of lack of knowledge, others because they don't want to know." Speier's bill was vetoed by Gov. Arnold Schwarzenegger -- who has admitted using steroids in his own body-building career -- on the ground that dietary supplements were best left to the FDA.

December 13, 2004 | Permalink | Comments (0)

President's Council on Bioethics: Transcripts Posted

Stemcellpic11 The President's Council on Bioethics web site has posted the transcripts of its meetings on Dec. 2 and 3, the latter being the date of Chairman Kass' comments about presentations that described two promising "morally unproblematic" sources of human embryonic stem cells. 

As discussed here previously, "[t]he two ideas considered by the council represent different ways to obtain embryonic stem cells without destroying an embryo:

One, crafted by council member Dr. William Hurlbut, a conservative bioethicist at Stanford University, would engineer a human egg so that it creates cells equivalent to human embryonic stem cells but never develops into an actual embryo.

The other idea, presented by two Columbia University professors, proposes devising standards for declaring an embryo ''dead." If it is ethically acceptable to allow organ donation from patients who have been declared brain dead, they reason, then it should be acceptable to remove cells from an embryo that has been declared dead.

Despite the support of at least some conservatives on the Council, proposal based upon "embryo death" has drawn fire from the Associate Executive Director of the Christian Medical & Dental Associations, Dr. Gene Rudd, in an interview that was background for a story in The Christian Post on Dec. 8.

December 13, 2004 | Permalink | Comments (0)

Sunday, December 12, 2004

More Holiday Health Hazards

First it was the CDC informing us about the dangers to be found in holiday decorating.  Now, Britain's Royal Society for the Prevention of Accidents (RoSPA), has issued guidelines on how to host a safe and successful office party.

According to RoSPA, the way to a safe Christmas party involves the following:

"Resist the temptation to photocopy parts of your anatomy," RoSPA and the Trades Union Congress (TUC) said. "If the copier breaks, you'll have Christmas with glass in painful places."

"Dancing on desks could do them and you a lot of damage," they said. "Likewise, the boardroom table is meant for weighty documents, not overweight executives."

Candles, flaming Christmas puddings and cigarettes should be avoided at all costs.

Stepladders, not swivel chairs, should be used to hang tinsel and mistletoe, which should not be hung near sources of heat.

"Keep a close eye on those who may drink too much," the organizations advised. "Alcohol makes some people aggressive rather than friendly. The party will be spoiled if it ends in a punch-up or harassment complaint."

December 12, 2004 | Permalink | Comments (0)

CMS Hotline Frequently Gives Wrong Answers

One of the GAO reports mentioned below made front-page news in today's New York Times and papers across much of the country picked the story up.  The story cited a 29% error rate on consumer calls and (citing a different report) an astonishing 96% error rate on billing questions from physicians:

Medicare's toll-free telephone line, one of the main vehicles for disseminating information about new prescription drug benefits and drug discount cards, gives accurate answers less than two-thirds of the time, Congressional investigators say.

In a test of the service, the investigators, from the Government Accountability Office, found that 29 percent of callers received inaccurate answers, while 10 percent got no answers at all. 

Use of the phone line is expected to soar in coming months as the elderly sort through a complex array of new insurance options and benefits.

Discount cards, available since May, can significantly reduce drug costs. But many beneficiaries hesitated to sign up, saying they were puzzled by the multiplicity of options. A government Web site compares drug prices under various cards, but many beneficiaries say they are not adept at using computers and find the site difficult to navigate.

In response, Bush administration officials say that beneficiaries can get all the information they need by calling 800-MEDICARE (633-4227). But the people who answer those calls are themselves often confused, the Government Accountability Office said, in an evaluation required by Congress under the new law.

"We found that 6 out of 10 calls were answered accurately, 3 out of 10 calls were answered inaccurately and we were not able to get a response for 1 out of 10 calls," the report said.

In another recent report, the accountability office found that Medicare provided even less accurate information to doctors who inquired about the proper way to bill for treating Medicare patients.

In response to 300 test calls, the accountability office said, customer service representatives gave correct and complete responses to only 4 percent of the billing questions. About 54 percent of the answers were simply wrong, and 42 percent were incomplete or partly correct, it said.

December 12, 2004 | Permalink | Comments (0)

Three New Reports from GAO

On Dec. 8 the Government Accountability Office released three new reports on health-care topics:

  • Medicaid Managed Care: Access and Quality Requirements Specific to Low-Income and Other Special Needs Enrollees GAO-05-44R, December 8, 2004
    • ABSTRACT: The use of managed care within Medicaid, a joint federal-state program that finances health insurance for certain low-income families with children and individuals who are aged or disabled, increased significantly during the 1990s. By 2003, 59 percent of Medicaid beneficiaries were enrolled in managed care, compared with less than 10 percent in 1991. Medicaid managed care, under which states make prospective payments to managed care plans to provide or arrange for all services for enrollees, attempts to ensure the provision of appropriate health care services in a cost-efficient manner. However, because plans are paid a fixed amount regardless of the number of services they provide, managed care programs require safeguards against the incentive for some plans to underserve enrollees, such as by limiting enrollees' access to care. Access is also affected by other factors, such as physician location and willingness to participate in managed care plans. Safeguards to ensure enrollees have access to care could include requiring plans to maintain provider networks that provide enrollees with sufficient geographic access to providers or requiring managed care plans to develop and monitor certain quality indicators, such as enrollee satisfaction surveys or grievances. The Balanced Budget Act of 1997 (BBA) gave states new authority to require certain Medicaid beneficiaries to enroll in managed care plans and also required the establishment of consumer protections for Medicaid managed care enrollees in areas such as access to and quality of care. In June 2002, the Centers for Medicare & Medicaid Services (CMS) issued final regulations for Medicaid managed care organizations (MCO) to implement these BBA requirements. The BBA directed us to examine the access and quality requirements applicable to MCOs operating under the Medicare program and to private sector MCOs to determine their relevance to the Medicaid MCOs. As discussed with the committees of jurisdiction, we examined the extent to which Medicaid MCO requirements specifically address the needs of enrollees who are low income, have special cultural needs (such as language differences), or have special health care needs (such as chronic illnesses or disabilities) in comparison to similar requirements applicable to Medicare and private sector MCOs.

      Medicaid MCO access and quality requirements specifically address the needs of managed care enrollees who are low income or have special cultural or health care needs, to an equal or greater extent than requirements applicable to Medicare and private sector MCOs. Regarding low-income enrollees, neither Medicare nor private sector requirements specifically address their needs as distinct from those of other enrollees. However, we identified one area that is key to access for low-income enrollees--transportation. Medicaid regulations and Medicare guidelines require that when developing their provider networks MCOs take into account the means of transportation--such as public transportation--enrollees use to access health care providers. No such explicit requirement applies to private sector MCOs. Regarding the cultural and language characteristics of enrollees, Medicaid regulations are more specific than Medicare and private accreditation requirements. While all requirements broadly state that services must be delivered in a "culturally competent manner," only the Medicaid regulations require that the primary language spoken by each individual be identified at the time of enrollment and that each managed care enrollee be provided with the names of and non-English languages spoken by contracted health care providers in the enrollee's service area. Additionally, Medicaid regulations require states to make oral interpretation services available and require that each MCO make these services available free of charge to each enrollee and potential enrollee. Regarding enrollees with special health care needs, Medicaid requirements are generally comparable to Medicare and private accreditation requirements. All require that individuals with special health care needs--such as chronic illnesses or disabilities--be identified and provided with appropriate services for managing these conditions.

  • Medicare: Accuracy of Responses from the 1-800-MEDICARE Help Line Should Be Improved GAO-05-130, December 8, 2004 Highlights-PDF PDF 
    • ABSTRACT: In March 1999, the Centers for Medicare & Medicaid Services (CMS) implemented a telephone help line--1-800-MEDICARE--to provide information about program eligibility, enrollment, and benefits. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) directed GAO to examine several issues related to this 24-hour help line and the customer service representatives (CSRs) who staff it. In this report, GAO evaluated (1) the accuracy of the information the help line provides, (2) the training given to CSRs, and (3) CMS's efforts to monitor the accuracy of information provided through the help line.

      The 1-800-MEDICARE help line provided accurate answers to 61 percent of the 420 calls we made and inaccurate answers to 29 percent. We were not able to obtain any answers for the remaining 10 percent of our calls at the time we placed them. Most of these calls were not answered because they were transferred to other contractors responsible for processing Medicare claims that were not open for business at the time we called or these calls were inadvertently disconnected. To facilitate accurate responses, the 1-800-MEDICARE help line provides CSRs with written answers--called "scripts"--that CSRs use during a call. When CSRs provided inaccurate information, it was largely because they did not seem to access and effectively use a script that answered our questions. CMS and its contractor do not routinely pretest the scripts to ensure that they are understandable to CSRs or potential callers. The training for CSRs meets CMS's requirements, but it is not sufficient to ensure that CSRs are able to answer questions accurately on the help line. Before handling calls, CSRs must complete about 2 weeks of classroom training; accurately answer two simulated calls consecutively out of six; and score at least 90 percent on a written exam. In addition, all CSRs receive ongoing training. However, the results from our calls indicate that the testing and simulated call answering did not sufficiently measure whether CSRs were prepared to answer questions accurately. CMS delegates most accuracy monitoring to one of its contractors and reviews the results. The bulk of the monitoring focuses on how accurately individual CSRs answer questions. However, this monitoring does not systematically track questions answered inaccurately by CSRs as a group, which could help target training and script improvement. Through two smaller studies that measured how accurately specific questions were answered, CMS was able to identify areas to improve scripts and training.

  • Medicare: Advisory Opinions as a Means of Clarifying Program Requirements GAO-05-129, December 8, 2004 Highlights-PDF PDF
    • ABSTRACT: Health care providers are concerned about the quality of Medicare guidance issued by the Centers for Medicare & Medicaid Services (CMS), an agency within the Department of Health and Human Services (HHS). Specifically, they have reported that (1) they receive unclear guidance on program requirements and (2) because policies and procedures change frequently, they may rely on obsolete guidance, resulting in billing errors. Some government agencies issue advisory opinions in response to specific questions from requesters. These opinions permit agencies to apply law and regulation to a particular set of facts and provide requesters with specific guidance. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 directed GAO to determine the appropriateness and feasibility of establishing in the Secretary of Health and Human Services authority to issue legally binding advisory opinions to interpret Medicare regulations. GAO (1) identified factors relevant in establishing an advisory opinion process and (2) assessed the role such a process could play in clarifying program requirements. GAO examined four federal agencies' advisory opinion processes and interviewed officials from organizations representing Medicare stakeholders to learn how such a process might address their concerns.

      GAO identified five common elements in the way four agencies--CMS, the Employee Benefits Security Administration (EBSA) of the Department of Labor, the Internal Revenue Service (IRS), and HHS's Office of Inspector General (HHS-OIG)--set up their advisory opinion processes. While the processes at the four agencies reflected differences in the agencies' respective constituencies and responsibilities, each agency cited five key factors as critical. These were (1) establishing criteria for submitting advisory opinion requests, to define the scope of their processes, (2) developing alternative ways of responding to advisory opinion requests, such as providing other forms of written communication, (3) determining the time frame for issuing advisory opinions, (4) considering anticipated workload, staffing requirements, and user fees as a means of offsetting expenses incurred by the government, and (5) creating internal review and external coordination procedures with other federal agencies with a stake in the outcome of an issued opinion. These five factors and lessons learned from other agencies that issue advisory opinions may be useful in structuring a process for Medicare. Most of the representatives of provider organizations GAO contacted agreed that an advisory opinion process would partially address their concerns, for example, by providing them with reliable, written responses to their Medicare-related questions. However, they recognized that an advisory opinion process would not address all their concerns and that it is one of several approaches that could improve Medicare guidance. For example, refining existing forms of guidance would also be of value. In commenting on a draft of this report, HHS stated that a more formal advisory opinion process for Medicare would be costly to implement, not provide quick answers to providers' questions, and have limited applicability. HHS acknowledged that the Medicare program and its implementing regulations are inherently complex and underscored its efforts to improve stakeholders' understanding of the program's complexities.

December 12, 2004 | Permalink | Comments (0)

Islamic Code of Medical Ethics Nears Adoption

As reported by, the 8th conference of the Islamic Organization for Medical Sciences (IOMS) opened in Cairo on Dec. 11 and is poised to adopt the first Islamic code for medical and health ethics:

The code idea dates back to 1981 when the IOMS took the initiative of adopting the Islamic Document for Medical Ethics in a Kuwait conference “to keep human knowledge on the proper track prescribed by God as He declared Man as His viceroy on this planet.”

There are numerous published versions of an Islamic code of medical ethics, but the most complete and authoritative appears on the web site of the IOMS itself.

The Code consists of an Introduction and thirteen sections:

  1. Definition of Medical Profession
  2. Characterization of Medical Practitioner
  3. Relation between Doctor and Doctor
  4. Relation between Doctor and Patient
  5. Professional Secrecy
  6. Doctor's duty in War Time
  7. Responsibility and Liability
  8. The Sanctity of Human Life
  9. Doctor and Society
  10. Doctor and Bio-Technological Advances
  11. Medical Education
  12. The Oath of the Doctor
  13. Topics in Islamic Medicine

Further commentary on Islamic medical ethics can be found in an essay by Dr. Hossam Arafa, "Ethics of the Medical Profession from the Islamic Viewpoint," and an article in the Canadian Medical Association Journal, "Bioethics for clinicians: 21. Islamic bioethics," by Abdallah S. Daar and A. Khitamy (PDF version).

December 12, 2004 | Permalink | Comments (0)