Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Friday, July 23, 2004
Long-term care: crisis.
Other recent coverage of this issue gives a glimpse into the looming crisis: "Long-Term Care Tests Governors" (Olympia (Wash.) Olympian) . . . "Congressional Briefing on Long-Term Care Alternatives" (U.S. Newsire) . . . Deborah Stone: "Shopping for Long-Term Care" (Health Affairs) . . .
Wednesday, July 21, 2004
JCAHO hit in GAO report for CMS.
As the Associated Press reports today (courtesy of the Indianapolis Star), the Government Accountability Office (GAO (formerly the "General Accounting Office")) has filed a report that is extremely critical of the performance of the Joint Commission for Accreditation of Healthcare Organizations (JCAHO (formerly the Joint Commission for the Accreditation of Hospitals)) in its role as the designated Medicare accreditation-surveyor for the Centers for Medicare and Medicaid Services (CMS (formerly the Health Care Financing Administration). (The link to the GAO report is probably not a stable address; if it stops working, try here.)
The report includes the following:
JCAHO’s pre-2004 hospital accreditation process did not identify most of the hospitals found by state survey agencies in CMS’s annual validation survey sample to have deficiencies in Medicare requirements. In comparing the results of the two surveys, CMS considered whether it was reasonable to conclude that the deficiencies found by state survey agencies existed at the time JCAHO surveyed the hospital. In a sample of 500 JCAHO-accredited hospitals, state agency validation surveys conducted in fiscal years 2000 through 2002 identified 31 percent (157 hospitals) with deficiencies in Medicare requirements. Of these 157 hospitals, JCAHO did not identify 78 percent (123 hospitals) as having deficiencies in Medicare requirements. For the same validation survey sample, JCAHO also did not identify the majority -- about 69 percent -- of deficiencies in Medicare requirements found by state agencies. Importantly, the number of deficiencies found by validation surveys represents 2 percent of the 11,000 Medicare requirements surveyed by state agencies in the sample during this time period. At the same time, a single deficiency in a Medicare requirement can limit the hospital’s capability to provide adequate care and ensure patient safety and health. Inadequacies in nursing practices or deficiencies in a hospital’s physical environment, which includes fire safety, are examples of deficiencies in Medicare requirements that could endanger multiple patients.The AP story provides a little more detail:
The potential of JCAHO’s new hospital accreditation process to improve the detection of deficiencies in Medicare requirements is unknown because the process was just implemented in January 2004. JCAHO plans to move from using announced to unannounced surveys in 2006, which would afford JCAHO the opportunity to observe hospitals’ operations when the hospitals have not prepared in advance to be surveyed. In addition, the pilot test of the new accreditation process was of limited value in predicting whether it will be an improvement over the pre-2004 process in detecting deficiencies. Limitations in the pilot test included that hospitals were not randomly selected to participate; that observers from JCAHO accompanied each surveyor, thus possibly affecting surveyors’ actions; and that JCAHO evaluated the results instead of an independent entity.
CMS has limited oversight authority over JCAHO’s hospital accreditation program because the program’s unique legal status effectively prevents CMS from taking actions that it has the authority to take with other health care accreditation programs to ensure satisfactory performance. For example, requiring JCAHO’s hospital accreditation program to submit to a direct review process or placing the program on probation while monitoring its performance. Further, CMS relies on a measure to evaluate how well JCAHO’s hospital accreditation program detects deficiencies in Medicare requirements that provides limited information and can mask problems with program performance, uses statistical methods that are insufficient to assess JCAHO’s performance, and has reduced the number of validation surveys it conducts.
Many of the overlooked problems related to fire safety, while others involved substandard care.Predictably, JCAHO isn't pleased with the report:
In a Texas hospital, a patient died after receiving a double dose of narcotics in the emergency room. A California hospital lacked "a sanitary environment to avoid sources and transmission of infections and communicable diseases and failed to develop a system for ensuring the sterilization of medical instruments," the report said.
Commission President Dennis O'Leary said his group made sweeping changes to the accreditation process earlier this year.What the AP story doesn't say (and I can't find it in the GAO report, either) is that in the 20+ years JCAHO has been in the "deeming" business with CMS, a few provisionally accredited hospitals have been denied full accreditation, but no fully accredited hospital has ever lost its accreditation. (If any reader can cite me an example that disproves this statement, I'd love to see it.) Long viewed as a toothless tiger by many in the industry, JCAHO ought to feel the sting of this GAO report. And, as denials go, President O'Leary's face-saving comment that "we're better than that now" isn't much of one.
"In our view, it is irresponsible to alarm the public using statistics that have little meaning," O'Leary said in response to the GAO report.
Tuesday, July 20, 2004
Genetic screening and . . .
Drug reimportation.
Blame the lawyers.
Public concern about medical, surgical and diagnostic errors is high and many Americans have doubts about the ability of medical institutions to prevent these types of errors, according to the latest WSJ Online/Harris Interactive health poll.
Sixty-three percent of those polled say they are "extremely concerned" or "very concerned" about medication errors, such as receiving the wrong medicine, that can take place in a hospital. And more than half of respondents are extremely or very concerned about surgical errors.And the source of this problem? According to Vice-President Cheney (as reported by Ceci Connolly in today's Washington Post, and brought to my attention by former student Jonathan Childers):
"This problem doesn't start in the waiting room," Cheney said in remarks released by the campaign. "It doesn't start in the operating room. The problem starts in the courtroom."Here's the quote you will hear over and over again from the Administration between now and the November election: "When it comes to the legal crisis in American health care, the Kerry-Edwards ticket is on the side of personal-injury trial lawyers, and the Bush-Cheney ticket is on the side of doctors and patients." Easy on the ears, easy on the brain. Sure beats having an actual plan to deal with this country's health care problems, doesn't it?
With lawsuits on the rise and multimillion-dollar awards making headlines, physicians and many Republicans say limiting damages is the solution to the broader challenges confronting the U.S. health system. In their analysis, capping damages will lead to lower malpractice premiums, which will reduce doctors' use of unnecessary tests and procedures, known as defensive medicine. Those improvements will result in better care at a lower cost, enabling more people to buy coverage, they say.
Monday, July 19, 2004
Class actions suits against non-profit hospitals.
- Several high-profile law firms have filed 31 cases against non-profit hospitals and hospital chains since late June. The cases make similar allegations, including: Some hospitals violate an implicit contract with the government to provide charity care in exchange for tax-exempt status by charging uninsured patients more than the insured or aggressively pursuing debts from low-income patients.
- Some facilities have large cash reserves they should use to provide charity care.
- They allow for-profit entities, such as doctor groups, to use their facilities to earn a profit.
- Hospitals named include the Cleveland Clinic; New York-Presbyterian; Sutter Health in Sacramento; Advocate Health Care Network in Chicago; Phoebe Putney Health Systems in Albany, Ga.; Baptist Health Systems in Alabama; and Catholic Healthcare Partners in Cincinnati.
Patient advocates, who were the first to publicize some of the concerns now included in Scruggs' cases, have mixed thoughts on the lawsuits. "This is a huge wake-up call," says Claudia Lennhoff of the Champaign County Health Care Consumers group in Illinois.
They also worry about the financial effect of the cases on non-profits.
"Having more scrutiny of billing practices is a good thing, but the risk is we're not taking on big tobacco, we're taking on a vital service," says Mark Rukavina of the Access Project, a national resource center that works with local groups on health care issues. "It's an industry I want to preserve, not bring down."
Some health law attorneys are skeptical that Scruggs' arguments will succeed.
"The behaviors they're targeting (billing and collection practices against the uninsured) are atrocious in some circumstances, but they're not illegal," says Gregg Bloche, a law professor of health law at Georgetown University. "The suits will fail."
Nor do they think there is an implied contract between hospitals and the government.
"That's never been recognized in the law," says Stuart Gerson, a partner at Epstein Becker & Green in Washington, D.C., who represents a hospital being sued. "The idea of an individual citizen, a taxpayer, seeking to enforce charitable obligations is, at least, a very novel argument that finds little support."
If any laws are being broken by the common hospital practice of allowing for-profit doctors to use their facilities, or if facilities are improperly steering business to trustees' companies, those arguments should be heard by taxing authorities or federal and state antitrust or anti-kickback regulators, Gerson says.
The lawsuits are renewing debate over the legal and ethical responsibility the nation's non-profits have to provide charity care.
"The IRS has never been really clear about what the grant of tax-exempt status means," says attorney John Reiss of the law firm Saul Ewing in Philadelphia. "It's never been clear that it actually commits you to providing any particular amount of charity care or anything else."
Non-profit hospitals say they provide a variety of charitable services. Hospitals have different ways of classifying such care, with some saying charity is providing medical services to anyone who walks in the ER, regardless of their ability to pay.
Others consider write-offs for bad debt charity care or financing community services, such as supporting health clinics.
Sunday, July 18, 2004
More on designer babies.
The HFEA's possible relaxation of the rules in this field is already stirring up opposition:A two-year-old boy who needs urgent treatment to cure a rare and potentially fatal blood disorder is at the centre of a fresh row over creating "designer babies" with human embryos.
The Human Fertility and Embryology Authority (HFEA) is poised to relax its rules on using genetic screening for medical treatments on Wednesday. The decision will have profound consequences for the life of Joshua Fletcher and children like him.
Joshua suffers from a rare genetic defect called Diamond-Blackfan anaemia, one requiring regular blood transfusions. His parents, Joe and Julie Fletcher, from County Antrim, Northern Ireland, have asked the HFEA to permit the genetic selection of a healthy sibling to help cure him by using that baby to donate healthy stem cells.
The present HFEA rule prevents parents selecting embryos solely because that child will have desirable characteristics, even if they will save another life - the central issue in Joshua's case.
Two years ago, the HFEA was heavily criticised for rejecting a similar bid by the family of Charlie Whitaker, who suffered from the same disorder. His parents instead flew to Chicago for fertility treatment, and had a genetically matched son. . . .
At present, embryos can only be screened before implantation using a technique called pre-implantation genetic diagnosis if there is a significant risk that the baby will itself be born with a critical or extremely serious genetic condition. Using that child to then treat another child is currently seen by the HFEA as a secondary benefit of the technique.
The proposal, which follows an HFEA rule review, has already provoked a fierce controversy over the religious and medical ethics of creating "made to order" babies simply to save another child's life. Critics claim embryo selection could easily lead to parents selecting babies because of their hair colour, gender or intelligence, and eventually to cloning.
Yesterday, a Christian think tank warned that an HFEA rule relaxation would be instantly challenged in the courts. Roger Smith, of the Centre for Bioethics and Public Policy, said: "The law says the welfare and best interests of the child being born has to be their primary consideration - not creating one life for the sake of another. That seems to us to be outside ethical boundaries."
The HFEA is also under intense pressure from fertility experts, parents and medical charities to soften its regulations after rejecting earlier bids by other families with Diamond-Blackfan anaemia. One family flew to the United States for treatment. Three further families with children with Diamond-Blackfan anaemia are preparing bids to the HFEA.
An HFEA spokeswoman said the authority could either reject the Fletchers' proposal or seek further information before making a decision.
Conceiving a child to save another.
An article in today's Arizona Daily Star discusses the practice of conceiving a child in order to produce a donor (bone marrow, cord blood . . . ), which the editors describe as "deeply controversial." In and of itself, it's hard to see where the moral objection, or the argument for regulation, comes in. The article identifies a few problems, only one of which focuses on the decision to conceive for the benefit of another:
- Dr. Michael Graham, director of pediatric bone-marrow transplantation at University Medical Center (in Phoenix): "The underlying principle of medical ethics is that no person can exist solely for somebody else's benefit. So I worried about creating a child specifically to create a donor." The key word in this Kantian objection is solely, which posits that the utilitarian reason for having another child is the only reason, rather than one of many. The fact that a child is born for reasons that benefit others (parents who want the additional companionship in older age, a sibling who would otherwise be an only-child) hardly seems like a reason not to conceive, as long as the child will be valued, loved, and protected in his or her own right.
- Of course, that last notion does give one pause, certainly when you hear about a family that plans to put the "donor baby" up for adoption after the donation has occurred (so far, a hypothetical concern only). Dr. Graham "was especially concerned about a North Carolina mother with a diseased child who took fertility drugs to try to have a 'donor baby,' even though she was divorced. She had twins, but neither turned out to be a match. 'So here are two more children in a split and strained family,' he said." True, but that North Carolina mom could have had babies for any reason, or no reason at all, with the same result. The question is how paternalistic do we want to be.
- In vitro fertilization raises other issues, at least for the Catholic church and others who object to the creation of multiple embryos, followed by genetic screening to identify the best match, and destruction of the unused embryos.
Interestingly, "some ethicists have argued it might be morally wrong not to have a donor or designer baby, if possible, when another child's life is at stake. 'In a situation that requires an intervention involving no sacrifice and no inconvenience by one child in order to save the life of another child, (this) is morally acceptable. It may even be morally required,' Dr. Merle Spriggs, head of the Ethics Unit at Royal Children's Hospital in Victoria, Australia, wrote in a British medical journal."
Saturday, July 17, 2004
Reimportation bill stalls in Senate.
COMPARING THE BILLS
Two U.S. Senate bills would allow drug importation into the United States from Canada and other countries. How they compare: Pharmaceutical Market Access and Drug Safety Act (Democrat-sponsored) [S.2328] 1. The FDA has 90 days to create rules permitting drug importation. U.S. pharmacies and drug wholesalers can import medicines from Canada in the first year and 19 other countries thereafter. Individuals could be shipped prescriptions from mail order or Web sites from FDA-approved Canadian pharmacies. 2. It's unlawful for drugmakers to limit supply or alter drugs to fail FDA standards. 3. A 1 percent user fee is imposed to fund FDA inspections. 4. Exporters to individuals must post a bond that they forfeit if they send unsafe drugs.
Safe Importing of Medical Products and RX Therapies Act (GOP-sponsored) [S.2493] 1. The FDA has one year to make safety recommendations before permitting imports from Canada and up to three years for 15 European Union countries. The FDA could ban drugs from some nations. 2. There is no provision making it unlawful to reduce supply or alter drugs to fail FDA standards. 3. A new, uncapped user fee program is established, paid for by all foreign and domestic businesses engaged in importation to pay for FDA inspections. 4. Licensing requirements and penalties are established for all online pharmacies that illegally conduct or solicit U.S. business.
Gary Hart: no joke.
Few Americans have more right to say ''I told you so'' than Gary Hart. During the 1990's, when the foreign policy establishment was obsessed with Star Wars and other issues left over from the cold war, Hart headed a commission on national security with another former senator, Warren Rudman. Its report, issued early in 2001, warned of catastrophic terrorist attacks in which ''Americans will likely die on American soil, possibly in large numbers.'' Incredibly, the work of the Hart-Rudman commission was widely ignored by the press and the Bush administration.
''The Fourth Power'' builds on the many ideas of the commission, offering sweeping recommendations for how America should orient its foreign policy in the 21st century. Hart's timely central argument -- an alternative to both the neoimperialist impulses of the Bush administration and the creeping Kissingerian realism of the Kerry campaign -- is that the traditional military, political and economic powers of American foreign policy should be constrained by and imbued with a fourth power, America's unique principles. To those who advocate a crusading foreign policy of preemption to ''rid the world of evil'' and spread democracy -- even at the point of a gun -- Hart argues that the first casualty would often be America's moral authority: ''There is a vast difference between advocating, as I do, that America live up to its own principles and advocating, as the Bush administration does, that the rest of the world live up to America's principles.'' At the same time, Hart counters Kerry's retreat to a Kissinger-style foreign policy, based largely on America's interests, with a humble but still idealistic internationalism, with the spread of liberal democracy at its core. It's a call for nation building without Abu Ghraib.
In 1993, Hart sent President Clinton a memo arguing that the end of the cold war was the ideal occasion to reorient the military ''for new missions relating to hostage rescue, counterterrorism, low intensity conflict, guerrilla warfare and stabilization of new democracies.'' Much of this prescient document is reprinted as an appendix. We were told.
Readers respond to PAS column by Kristof.
Wednesday, July 14, 2004
Assisted suicide and Ashcroft.
On Monday, Ashcroft's Justice Department sought reconsideration by the appellate court, which prompted a thoughtful op-ed piece by Nicholas D. Kristof in today's N.Y. Times. Even if you (like me) thought the Oregon law was a bad idea, this is worth reading. I admit that I've come around on this subject because of the Oregon experiment, and Kristof highlights important aspects of that experience quite well.
House votes to allow Canada drug imports.
Federal marriage amendment dies in Senate.
The vote by the Republican-controlled Senate amounted to an embarrassing defeat for President Bush and conservative leaders who had pushed hard for approval of the amendment as a way of protecting traditional marriage. But Senate GOP leaders vowed to continue pushing for the amendment, hoping it will galvanize conservatives in the November election and help elect more supporters of the amendment.The World's Greatest Deliberative Body comes through again!
"This issue is not going away," Majority Leader Bill Frist (R-Tenn.) said.
Tuesday, July 13, 2004
CMS: Lying to Congress.
Regardless of the legal technicalities, it is a terrible policy to deprive legislators of information they need to make informed choices. Mr. Foster has said that he shared his estimates not only with Mr. Scully, but also with Doug Badger, President Bush's health policy adviser. Both Mr. Scully and Mr. Badger declined an invitation to appear before the House Ways and Means Committee in April. The committee should call both men again, under subpoena if necessary, to answer questions about what looks like a conspiracy to keep Congress in the dark.Amen.
Physician recruitment on FBI's radar.
Monday, July 12, 2004
Nonprofits under scrutiny.
Late-term abortion law struck down again.
Saturday, July 10, 2004
Bush's marriage thing.
Science & politics redux.
For years, Advocates for Youth, a Washington-based organization devoted to adolescent sexual health, says, it received government grants without much trouble. Then last year it was subjected to three federal reviews.Sound paranoid? It gets worse: "Professor Parker is also a co-chairman of the International Working Group on Sexuality and Social Policy, an association of researchers and other professionals, which released a report two weeks ago citing examples of what it called sex policing under the Bush administration. The report cited, for example, changes in factual information about sex education and H.I.V. transmission on government Web sites as well as questioning by members of Congress about research grants approved by the National Institutes of Health."
James Wagoner, the president of Advocates for Youth, said the reviews were prompted by concerns among some members of Congress that his group was using public funds to lobby against programs that promoted sexual abstinence before marriage. Although that was not the case, Mr. Wagoner said, the government officials made their point.
"For 20 years, it was about health and science, and now we have a political ideological approach," he said. "Never have we experienced a climate of intimidation and censorship as we have today."
Mr. Wagoner is among the professionals in sex-related fields who have started speaking out against what they say is growing interference from conservatives in and out of government with their work in research, education and disease prevention.
A result, these professionals say, has been reduced financing for some programs and an overall chilling effect on the field, with college professors avoiding certain topics in their human sexuality classes and researchers steering clear of terms like sex workers in the title of grant applications for fear of drawing attention to themselves.
"Programs almost have to hide what they do," said Richard Parker, a professor at the Mailman School of Public Health at Columbia University. "We have a major challenge ahead of ourselves."