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GOVERNMENT WATCH

PATIENT SAFETY ISSUESIN THE HHS BUDGET

As part of his 2003 budget, President Bush designated an additional $10 million for patient safety issues, raising the total budget to $84 million. The goal of this increase is to “make a measurable improvement in the safety of health care for Americans,” according to a news release from the Department of Health and Human Services (HHS), which reported that between 44,000 and 98,000 people die from medical errors each year, and such errors cost up to $29 billion annually.

Led by the Agency for Healthcare Research and Quality (AHRQ), this initiative will involve cooperation from the Centers for Disease Control and Prevention, Food and Drug Administration, and Centers for Medicare and Medicaid Services, all of which currently participate in the HHS Patient Safety Task Force formed by Secretary Tommy Thompson last year.

Through this cooperative effort, the HHS plans to address patient safety from a number of angles. To increase the reporting of adverse events nationwide, the FDA will receive an additional $5 million to improve adverse effect reporting technologies, increase follow-up capabilities, and streamline information dissemination methods.

The AHRQ will spend $60 million of its budget to provide grants encouraging the adoption of safe but underused medical technologies. Two million dollars will also go toward training on-site safety experts who will work with state and local institutions to improve medical safety.

However, some question the feasibility of this plan, citing that the AHRQ's total budget is only $215 million, a 16 percent reduction from 2001. The cut is meant to “achieve efficiencies in research activities in the Department,” but experts fear that the increased responsibility of the patient safety initiative and the reduction in the budget will leave room for little besides the initiative.

STOP STROKE ACT PASSES SENATE

In February, the Senate unanimously passed the Stroke Treatment and Ongoing Prevention (STOP) Stroke Act. The act was introduced by Health, Education, Labor, and Pensions Committee Chairman Edward M. Kennedy (D-MA) and Senator Bill Frist (R-TN).

The STOP Stroke Act provides for a system of education, research, and treatment to reduce the human and financial cost of stroke. Some of the act's provisions are:

  • ♦ Grant money for states to create stroke prevention, treatment, and rehabilitation systems, totalling $50 million in 2002, $75 million in 2003 and 2004, $100 million in 2005, and $125 million in 2006.
  • ♦ In FY 2002, $40 million for a national multimedia stroke awareness and prevention campaign, to be administered by the Department of Health and Human Services.
  • ♦ Support for the Paul Coverdell Stroke Registry and Clearinghouse, for its mission in gathering stroke data and disseminating it to researchers.
  • ♦ Development of standards of care for stroke patients and training guidelines for health care workers, by the HHS.
  • ♦ Public and non-profit grants for diagnostic approaches, technologies, and therapies for stroke, administered by the HHS.

The House must now approve the act before it can be implemented. A companion act to the Senate's was introduced by Reps. Charles Pickering (R-MS) and Lois Capps (D-CA). At press time, the act was being reviewed by the House Committee on Energy and Commerce.

WHILE US CONGRESSDEBATES THERAPEUTIC CLONING, GREAT BRITAINLEGALIZES IT

The Senate vote on therapeutic cloning, originally expected in March, may now be delayed as Senators are bombarded by media campaigns from pro-and anti-cloning organizations. As reported in the March 6th New York Times, several anti-cloning organizations are running advertisements urging undecided Senators in Utah, North Dakota, and Georgia to support Senator Brownback's (R-KS) bill banning cloning of all types. Not to be outdone, pro-cloning groups held a press conference with pleas from actor Christopher Reeve, who was paralyzed in a horseback-riding accident; Nobel laureate and cancer researcher Paul Berg; and movie producer Jerry Zucker, whose daughter has juvenile diabetes.

The Senate is currently considering both a bill banning all human cloning and a bill banning reproductive cloning, but allowing human cloning for research purposes. The House passed a bill banning all types of human cloning in 2001, and now the Senate must decide whether to continue the debate by legalizing therapeutic cloning or to end the issue by passing a bill similar to the House's.

The US is not the only nation to wrestle with the ethical issue of therapeutic cloning. In February, a committee in Great Britain's House of Lords decided that British scientists could legally clone human embryos for research purposes. The cloning legislation had been revised and upheld at court earlier in the year, but researchers had been waiting on an announcement from the House of Lords to proceed with experiments.

According to a news conference reported on Cable News Network in February, the House of Lords committee Chairman said, “No avenue of research should be blocked off at this stage.” Britain was the first nation to explicitly condone embryo creation for the purpose of extracting stem cells, and its decision will no doubt be a factor as the US Senate considers legislation on human cloning.

The decision opens many research opportunities for scientists, but the British government plans to keep a close eye on such research as it proceeds. To this end, the House of Lords recommended the creation of a stem cell bank that would collect and store all cloned cells. Researchers would have to search the bank for cells suitable to their research needs before cloning additional embryos. Depositing cloned cells in the bank would also be a requirement for all researchers wishing to clone human embryos.

ANTITRUST HEALTH CARE LEGISLATION INTRODUCED

In March, US House of Representatives Congressmen Bob Barr (R-GA) and John Conyers (D-MI) introduced the Health Care Antitrust Improvements Act of 2002, bipartisan legislation that would allow physicians and other health care professionals to collectively negotiate with their health plans over contractual terms or plan policies. Presently, joint negotiations with health plans are illegal under the federal antitrust law if they involve fees or prices. Under the legislation, the activities would be subject to review based on their reasonableness, which could take quality of health care into account.

The bill was submitted for consideration to the House Committee on the Judiciary on March 7.

In remarks cited in the March 7th Congressional Record, Mr. Conyers said the legislation “responds to two alarming anti-consumer trends – the ever increasing level of concentration among health insurers and exclusionary contracting practices by health insurance companies.”

Mr. Conyers pointed out that massive consolidation in the health insurance and managed care market has eliminated more than a dozen health insurance competitors through mergers and acquisitions. As a result of these consolidations, he said, health insurers have engaged in heavy-handed negotiating tactics and required exclusionary contractual commitments from health care providers.

“These contractual terms are frequently proffered on a ‘take it or leave it’ basis to health care providers, under the threat of the loss of the provider's patients or exclusion from their access to other patients,” said Mr. Conyers.

Mr. Conyers said he has taken a particular interest in this legislation because of the unfairness of the current market situation for African American doctors. “I am aware of a number of incidents in Detroit and around the country of minority physicians being threatened that they will lose all of their business unless they enter into one-side service contracts. This bill gives physicians the ability to respond to these abuses on a collective basis.”

RESEARCH ANIMAL DEBATEIN CONGRESS

Laboratory scientists who conduct neurologic research on animal models might be relieved to know that in February, the Senate passed, as part of its Farm Aid Bill, a provision exempting birds, rats, and mice from the status of “animal” in regard to the Animal Welfare Act. The bill will exclude these animals from care of research animal regulations.

Research organizations, such as the Federation of American Societies for Experimental Biology (FASEB), support the bill. Through Op-eds and news releases, FASEB pointed out that the care of research animals is already monitored and that additional requirements will create more work and expense with no benefit to the animals. Birds, rats, and mice account for over 90 percent of the animals used in research in the Unite States.

The provision of the Animal Welfare Act, sponsored by Senator Jesse Helms (R-NC), was influenced, in part, by efforts of the Alternatives Research and Development Foundation (ARDF) to extend protection to rats, mice, and birds. In 2000, the US Department of Agriculture (USDA) agreed to rewrite certain rules that define what an “animal” is, and therefore what is protected under the Animal Welfare Act, as part of an agreement with the ARDF.

Congress tried, unsuccessfully, to pass a similar provision disallowing birds, rats, and mice “animal” status as part of its FY 2002 Agriculture Appropriations bill. The House's original version of the bill forbade the USDA from including birds, rats, and mice as “animals,” and denied any federal funding to rewrite the related rules. The Senate bill, however, did not address the issue, and the final Agricultural Appropriations bill permitted the USDA to issue a proposed – but not final – rule on the classification of birds, rats, and mice in 2002.

The provision to the Farm Aid bill will now be considered by the House before a final decision is reached.

MEDICAL GROUPS SUE TO STOP MEDICAID CAP

In the March “Government Watch” column (page 27), Neurology Today reported on the growing controversy over the greatly reduced Medicaid payment cap. The new cap, announced by the Department of Health and Human Services (HHS) in January, reduces the amount that states can pay city and county owned public hospitals from 150 percent of the Medicare rate to 100 percent. Organizations representing health care providers and hospitals protested that the cap would cripple the nation's safety net hospital system, promising to take the issue to court to prevent the new cap.

On March 7th, they made good on that promise. Four medical organizations – the Association of American Medical Colleges, the American Hospital Association, the National Association of Children's Hospitals and Related Institutions, and the National Association of Public Hospitals – filed suit against the HHS. The suit, filed in the Eastern United States District Court in Arkansas, charges the HHS with violating the Administrative Procedures Act. It claims that the Medicaid payment cap is arbitrary and capricious, and that it will irreparably harm the public hospitals of America.

The payment cap was to have gone into effect on March 19th, but will now be delayed until the court case is settled.

ANOTHER TRY FOR BUSH'S DRUG DISCOUNT CARD

In March, President Bush announced a revised version of his Medicare Prescription Drug Discount Card plan. The original plan, announced in July 2001, was stopped by a lawsuit from pharmacy groups that argued that the plan violated a number of federal laws.

As reported in the Washington Post in March, the revised plan allows Medicare to grant official approval to organizations able to negotiate drug discounts for large numbers of medicare patients. The organizations could then create discount cards and sell them to Medicare recipients. Although specific discount amounts have not been announced, the average discount is expected to be about 15 percent.

The original proposal called for drug benefit management companies to negotiate discounts and create the cards, which would then be sold by pharmacies for up to $25.

The prescription drug plan was integral to President Bush's plan for reforming Medicare to provide higher quality care to seniors while improving the financial situation of the program. The plan fulfills one of President Bush's eight principals of Medicare reform: “All Seniors should have the option of a subsidized prescription drug benefit as part of modernized Medicare.”