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Week Ending
Friday, December 15, 2006
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© 2006 by National Journal Group Inc., 600 New Hampshire Ave., N.W.,
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CONGRESS: OKs Bill To Address Medicare MD Payments, Expand HSAs
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The 109th Congress adjourned on Saturday after the passage of a bill (HR 6408) that includes a provision to reverse a 5.1% reduction in Medicare physician reimbursements scheduled to take effect in January 2007, the Washington Post reports (Weisman, Washington Post, 12/10). The legislation would maintain the current level of Medicare physician reimbursements next year and would provide a 1.5% increase in reimbursements to physicians who agree to report data on certain quality-of-care measures. Under the bill, the increase in Medicare reimbursements would "be based on whether the physician reports the data, but the system lays the groundwork for higher payments to better-performing physicians," the Wall Street Journal reports (Lueck, Wall Street Journal, 12/11). The legislation also would provide $4.9 billion for health benefits for retired coal miners and mine reclamation (Rogers, Wall Street Journal, 12/11).
HSA Provision
In addition, "Republican lawmakers, with little public debate, quietly added a billion-dollar" provision to the bill to encourage the use of health savings accounts, the Post reports (Birnbaum/Montgomery, Washington Post, 12/11). The legislation would eliminate a requirement that annual contributions to HSAs not exceed the amount of the annual deductibles for the health plans to which they are linked. "Many people with HSAs have health insurance deductibles at or near the minimum required to set up the accounts -- about $1,000 or $2,000 a year," but the bill would increase the maximum annual contribution to $2,850 for individuals and $5,650 for families, the Journal reports. Rep. Eric Cantor (R-Va.), who sponsored the provision, said, "It's not the be-all, end-all or a panacea, but it is a step in promoting personal choice in health care." Paul Dennett, vice president for health policy at the American Benefits Council, said, "It helps HSAs fulfill their purpose as savings accounts and not just as annual spending accounts." According to the Journal, the "changes represent a last-ditch expansion of HSAs before the takeover by Democrats, who tend to view the accounts as helping the healthy and wealthy at the expense of taxpayers" (Wall Street Journal, 12/9).
Comments
Outgoing Senate Majority Leader Bill Frist (R-Tenn.) said, "Just when everyone bet against us, Republicans put together a broad package of energy, tax, trade and health care measures." Sen. Edward Kennedy (D-Mass.) said, "Tonight, Congress put partisanship aside to do the right thing for the health of millions of Americans." However, some lawmakers criticized Republican congressional leaders for "irresponsibly leaving ... major unfinished business," the New York Times reports (Hulse, New York Times, 12/10). Congress voted to delay the completion of nine of 11 fiscal year 2007 appropriations bills and approved a continuing resolution that would fund operations for most federal agencies until Feb. 15, 2007 (Chaddock, Christian Science Monitor, 12/11). Outgoing House Appropriations Committee Chair Jerry Lewis (R-Calif.) said, "The breakdown of regular order this cycle -- indeed the failure to get our bills done -- should be squarely placed at the feet of the departing Senate majority leader who failed to schedule floor time for the consideration of appropriations bills" (New York Times, 12/10).
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MEDICARE: Bill Would Require HHS To Negotiate Rx Drug Prices
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Incoming House Speaker Nancy Pelosi (D-Calif.) on Thursday at a briefing outlined priorities for Democrats in the first 100 hours of the 110th Congress and said they will seek to pass legislation that would require HHS to negotiate directly with pharmaceutical companies on the prices of medications under the Medicare prescription drug benefit, CQ HealthBeat reports. According to CQ HealthBeat, "There had been some speculation that Democrats might merely grant HHS negotiating authority not mandate it." Pelosi said that the legislation, one of the "Six for '06" bills that Democrats will seek to pass in the first 100 hours of the 110th Congress, would provide the HHS secretary with "the power, not only that, the mandate to negotiate for lower prices." Democrats will move the six bills, which include legislation that would increase federal funding for embryonic stem cell research, directly to the House floor for consideration, Pelosi said. President Bush "seems almost certain" to veto both of the health care bills in the event that Congress approves them, CQ HealthBeat reports (CQ HealthBeat, 12/14).
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UNIVERSAL HEALTH INSURANCE: Wyden To Introduce Legislation
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Sen. Ron Wyden (D-Ore.) on Wednesday announced plans to introduce legislation early next year that would guarantee health insurance for all U.S. residents, CQ HealthBeat reports. Under the legislation, private health insurers would provide coverage to individuals directly, rather than through employers, and employers initially would shift funds currently used to pay for coverage to employee wages (CQ HealthBeat, 12/13). Over time, employers would to pay the federal government a health insurance contribution. The legislation would require individuals to use the funds contributed by employers to purchase through state purchasing pools private health insurance, which would provide coverage at the same level as the BlueCross BlueShield Standard Plan offered to federal employees. Individuals would not have to pay higher income taxes as a result of the funds they receive from their employers (Alonso-Zaldivar, Los Angeles Times, 12/14). State "Health Help Agencies" would provide information and advice to help individuals purchase private health insurance (CQ HealthBeat, 12/13). Uninsured individuals also would have to purchase health insurance, but the federal government would fully subsidize premiums for low-income individuals and partially subsidize premiums for middle-income individuals (Los Angeles Times, 12/14). Individuals who fail to purchase health insurance would have to pay fines (CQ HealthBeat, 12/13). The federal government would collect premiums paid by individuals and contributions from employers through the tax system and distribute the funds to health insurers. The legislation would apply to individuals until they reach retirement and would not apply to Medicare beneficiaries (Los Angeles Times, 12/14). In addition, the legislation would not apply to individuals who receive health insurance through the U.S. military (Daly, AP/Washington Examiner, 12/13).
Analysis
According to the Times, the legislation would "guarantee coverage for all, including nearly 47 million uninsured -- a Democratic objective" -- and would also "limit employers' exposure to relentless cost increases and encourage workers to shop for cost-effective insurance plans -- GOP goals." However, the legislation is "complex" and "not likely to be easily enacted," and most experts "believe major health care reform will only be possible with the support of a president elected on a promise to tackle the problem," the Times reports.
Comments
Wyden said, "The last time America tried to fix health care was in 1993 and 1994 -- since then, employer-based coverage has been melting away like a Popsicle in the sun. Business leaders in 1994 who said, 'We can't afford to reform health care,' are now saying, 'We can't afford not to reform health care.'" Safeway Supermarkets CEO Steve Burd, who joined Wyden at a news conference to announce the legislation, said, "Without some dramatic change, not only will the uninsured population continue to grow, but the American worker will become less competitive" (Los Angeles Times, 12/14). Service Employees International Union President Andy Stern, who also joined Wyden at the news conference, said that the legislation "has a real chance of having a successful conclusion" (CQ HealthBeat, 12/13). Ron Pollack, executive director of Families USA, called the legislation "a first step" and "a work in progress," adding, "We are very supportive of the goals Sen. Wyden has established" (Los Angeles Times, 12/14). Karen Ignagni, president and CEO of America's Health Insurance Plans, said, "This is something that needs to be prioritized by the country, and we're going to be a participant" (CQ HealthBeat, 12/13). More information on the legislation is available online.
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FDA: Proposes Plan To Widen Access to Experimental Drugs
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FDA on Monday released a proposal that would ease access to unapproved medications for certain patients and allow pharmaceutical companies to charge patients for the drugs in some cases, the Washington Post reports (Stein, Washington Post, 12/12). Since the 1970s, FDA has made experimental drugs available to individuals or groups of patients under compassionate-use programs. The new guidelines offer additional details on the circumstances under which experimental drugs can be made available (USA Today, 12/12). Under the new guidelines, FDA would clarify that drugs could be available during all stages of drug development, including during Phase I testing (Bridges, AP/Seattle Post-Intelligencer, 12/11). The proposal includes measures to allow patients to find out more easily how to access experimental drugs. The guidelines also would give scientists, small research organizations and drug companies a method for calculating how much they can charge patients for the experimental drugs, possibly allowing them to make the treatments available to more people (Washington Post, 12/12). The rules would allow manufacturers to charge for the cost of making and providing an experimental drug, but they would not be permitted to make a profit (Corbett Dooren, Wall Street Journal, 12/12). The proposed guidelines will be subject to public comment for 90 days.
Comments
Janet Woodcock, FDA deputy commissioner for operations, said the FDA's guidelines attempt to find an acceptable balance between helping people with critical medical conditions and protecting patient safety and the drug development process. Woodcock said, "FDA hopes this proposal will increase awareness in the health care community of the range of options available for obtaining experimental drugs for seriously ill patients" (Cohen, Newark Star-Ledger, 12/12). However, some observers worry the regulations could leave patients vulnerable to dangerous medicines and could make it more difficult to recruit patients for clinical trials. Sidney Wolfe of Public Citizen's Health Research Group said, "It seems like it could be unleashing some floodgates that could do more harm than good for a number of people" (Washington Post, 12/12). Others believe the guidelines still are too restrictive. Frank Burroughs, president of the Abigail Alliance for Better Access to Developmental Drugs, said the proposal does not go far enough to ensure quick access to potentially lifesaving treatments (Manor, Chicago Tribune, 12/12).
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FDA: Panel Recommends Warning for Adult Antidepressant Suicide Risk
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An FDA advisory panel on Wednesday voted 6-2 in favor of updating black box warnings on antidepressants to state that there is an increased suicide risk for young adults up to age 25, the New York Times reports (Carey, New York Times, 12/13). FDA recently completed a review of antidepressant studies, which suggested that people ages 18 to 24 who take antidepressants are more than twice as likely to consider or attempt suicide as those who take placebos. The FDA review included 372 studies involving about 100,000 patients and 11 antidepressants (American Health Line, 12/13). According to FDA's review, for every 1,000 young adults ages 18 to 24 who are given the drugs, about four will act on suicidal thoughts who otherwise would not have done so. The review found that the drugs did not increase the risk of suicide in adults ages 25 to 65 and that they significantly lowered the risk of suicide in people older than 65. Antidepressants since 2004 have carried a black box warning about an increased risk of suicidal thoughts and actions in children and adolescents (New York Times, 12/13). FDA proposed adding new warnings about suicide risk in young adults, which the advisory panel has now endorsed. The advisory panel "also encouraged the FDA to add language to the black box about the importance of treating depression in hopes that the addition of new warnings won't cause doctors to limit the antidepressant prescriptions," the Journal reports (Wall Street Journal, 12/14).
FDA Comments
Thomas Laughren, director of FDA's division of psychiatry products, said, "We don't know" why antidepressants appear to have different effects on different age groups (Graham, Baltimore Sun, 12/14). Laughren said FDA is leaning toward expanding the black box warning to include young adults, and agency officials said they will try to write language that would encourage health care providers to prescribe the drugs carefully, not abandon them, the Washington Post reports. Robert Temple, director of FDA's Office of Medical Policy, said that regulators are in a difficult position because they are obligated to warn physicians about monitoring patients for suicidal tendencies but also are concerned that the warning might lead doctors to stop prescribing the drugs (Vedantam, Washington Post, 12/14).
Testimony
Davis Shern, president of Mental Health America, said that the current black box warning for children and adolescents has resulted in a 20% drop in antidepressant prescriptions for those age groups. At the same time, Shern noted the suicide rate for children and adolescents has increased, according to some estimates. He said, "A black box warning will scare people away from treatment and end up causing greater harm than it does good" (Baltimore Sun, 12/14). Christopher Kratochvil, a psychiatrist and spokesperson for the American Academy of Child and Adolescent Psychiatry; John Mann, a psychiatrist and spokesperson for the American Foundation for Suicide Prevention; and Donna Barnes, president of the National Organization for People of Color Against Suicide, all said that new suicide warnings might harm depression patients by making them afraid of treatment. However, British psychiatrist David Healy and Harvard University lecturer and psychiatrist Joseph Glenmullen said that FDA's review downplayed the risk of suicide from antidepressants and suggested that several suicides in industry-sponsored studies were never disclosed, the Post reports. Healy said, "Industry controls the data, and industry with the aid of FDA have miscoded the data so all the articles in all the journals that purport to represent clinical trial data are misleading." Healy added, "The idea you would have a risk in one age group but not another is just wrong" (Washington Post, 12/14). Panel member Marcia Slattery, a psychiatrist at the University of Wisconsin, said, "I am concerned that there is a false sense of security to some of these age brackets."
Family Members' Testimony
The advisory panel's vote followed "emotional" testimony from family members, some of whom "pleaded for strong warnings on drugs that they believed had caused loved ones' suicides," the Los Angeles Times reports (Gellene, Los Angeles Times, 12/14). Suzanne Gonzales, a witness whose husband shot himself while being treated with Paxil, said, "I wake up every morning thinking, 'Oh my God. He is freaking dead.' Do you wake up and think, 'How many people are going to die today because I am doing nothing?'" (Bridges, AP/South Florida Sun-Sentinel, 12/14). Kim Witczak, whose husband committed suicide one month after being prescribed Zoloft for sleeping problems, said, "No one is saying here, 'These drugs are too dangerous, and we've got to take them off the market.' All we're saying is, giving doctors and patients information about what the risks are and let them make an informed decision about what they want to do" (Baltimore Sun, 12/14). Some former patients at the hearing testified that they believed antidepressants had saved their lives (New York Times, 12/13).
Industry Comments
Pfizer, which manufactures Zoloft, said its data do not show an increased risk of suicide in young adults. A spokesperson for Eli Lilly, which makes Prozac and Cymbalta, said the company is concerned that a black box warning might dissuade people who need treatment from getting it and added that a warning label should balance information about the benefits of the drugs. GlaxoSmithKline said it changed its warning label for Paxil in May to include a risk of suicide in young adults. A spokesperson for Wyeth, which makes Effexor, said that antidepressants have saved many lives and added that some people who commit suicide while taking antidepressants would have committed suicide without the treatment (Wall Street Journal, 12/14).
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FDA: Panel Recommends More Warnings About Drug-Eluting Stents
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FDA should warn doctors and patients that the safety of drug-eluting stents has not been established for relatively high-risk patients for whom the stents are not approved, a group that accounts for the majority of stenting procedures, an agency advisory panel said last week, the Washington Post reports (Stein, Washington Post, 12/9). Drug-coated stents, which are sold in the U.S. by Boston Scientific and Johnson & Johnson, are designed to prevent scar tissue from forming in arteries after angioplasty. However, recent studies have suggested the devices might increase the risk of blood clots compared with bare-metal stents. Drug-coated stents are approved by FDA for use in patients with simple artery blockages, but the agency estimates that at least 60% of procedures involving the devices are performed in patients with more complex conditions, such as heart attacks, multiple blockages requiring more than one stent or blockages in more than one branch of an artery. FDA asked the advisory panel to examine the risks of blood clots, heart attack and death for approved and off-label uses of drug-coated stents compared with bare-metal stents. On Thursday, the panel said there is no conclusive evidence that drug-eluting stents increase the risk of heart attack or death when used within the scope of their FDA approval (American Health Line, 12/8). After reviewing research on off-label use of drug-coated stents, the panel said that such use appears to raise the risk of blood clots, heart attack and death. The panel said it is unclear whether the increased risk is caused by the drug-coated stents or if it is a result of the poorer health of the higher-risk patients. Until that effect can be determined, FDA should warn doctors and patients of the potential risks, the panel said (Washington Post, 12/9).
Anticlotting Drugs
The panel also said that patients should take an anticlotting medication, such as Bristol-Myers Squibb's Plavix, and aspirin for at least one year after receiving a drug-coated stent. Currently, the label for J&J's Cypher stent recommends that patients take anticlotting drugs for three months, and the label for Boston Scientific's Taxus stent recommends use of the drugs for six months. According to the New York Times, it is "unclear" how FDA will respond to the recommendations. The agency "cannot require the companies to recommend a drug program on their labels for an unapproved use of the device," and BMS "is not allowed to market the drug for off-label stent use," the Times reports.
FDA
Daniel Schultz, head of the Center for Devices and Radiological Health at FDA, said, "What I heard loud and clear is that we need to do a better job communicating to doctors and patients the best and latest information." He said it is too soon to discuss what specific actions FDA might take (Feder, New York Times, 12/9). "There may be things that can be done relatively quickly," Schultz said, adding that the options include a label change or a letter to doctors and patients.
Comments
Panel Chair William Maisel of Beth Israel Deaconess Medical Center said, "If you use the device outside [the approved] indication, you're going to have a higher incidence of complications." Panel member Steven Nissen of the Cleveland Clinic said, "Do we have evidence that the safety-efficacy balance might be different in the off-label [use]? I think we've heard enough to suggest that that's the case" (Washington Post, 12/9). Panel member Robert Harrington of Duke University said, "It's really a societal question. What do you do when you have a technology that is potentially so transforming that it will be used in virtually everybody, even though it has only been studied in a minority of people?" (Sternberg, USA Today, 12/11).
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BREAST CANCER: Lower Rate Linked to Reduced HRT Use
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Breast cancer incidence among U.S. women dropped by 7% from 2002 to 2003, possibly because of a decrease in hormone replacement therapy usage, according to a study presented Thursday at the 29th Annual San Antonio Breast Cancer Symposium, the New York Times reports (Kolata, New York Times, 12/15). Peter Ravdin, a research professor in the Department of Biostatistics at M.D. Anderson Cancer Center, and colleagues examined records from nine regions across the U.S. that supply data to the National Cancer Institute's Surveillance Epidemiology and End Results. According to the study, age-adjusted breast cancer incidence decreased by 7% by the end of 2003, compared with 2002 (M.D. Anderson release, 12/14). There were about 124 breast cancer cases per 100,000 women in 2003, compared with about 134 cases per 100,000 women in 2002, the AP/Forbes reports. Breast cancer incidence decreased by 6% in the first half of 2003 and by 9% in the second half of the year (Marchione, AP/Forbes, 12/15). The study found that breast cancer rates dropped by 15% among women ages 50 and older (Peres, Chicago Tribune, 12/14). The study -- which was funded by NCI and M.D. Anderson -- concluded that about 14,000 fewer women were diagnosed with breast cancer in 2003 than 2002. The decline in incidence was the largest since 1990, according to the researchers.
Potential Reasons for Decline
According to researchers, the decrease in breast cancer rates is most likely associated with a drop in both HRT use and mammography rates (Gellene, Los Angeles Times, 12/15). According to the Wall Street Journal, HRT use decreased by about 30% in 2002 after the Women's Health Initiative found that breast cancer risk increased for women who used the treatment for an extended period of time. In addition, mammography rates between 2000 and 2003 dropped by 1% overall and by 3% among women between ages 50 and 64, which could in part explain why fewer breast cancer cases were detected, according to the Journal (Parker-Pope, Wall Street Journal, 12/15). Ravdin said that it is possible that other factors -- including anti-estrogen drugs, such as raloxifene; statin drugs that reduce cholesterol; or drugs used to treat pain -- also might have contributed to the decrease (Chicago Tribune, 12/14). Although the study does not prove a causal link between the drop in breast cancer rates and HRT usage, it is the only plausible explanation, Rowan Chlebowski of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and co-author of the study, said, adding, "To have this kind of drop in cancer rates you need something very big to explain it" (Los Angeles Times, 12/15). According to the Journal, it is possible certain types of cancer would have developed faster with continued hormone use but still will eventually develop. "It's quite likely that some of these tumors have just been slowed and that we're going to see a boost in incidence in the next few years," Donald Berry, head of the division of quantitative sciences at M.D. Anderson and co-author of the study, said, adding, however, that "[t]here may be some tumors that actually stop growing because the only thing they were living on was the fuel of the hormones." Ravdin said, "The long-term impact [of the study] is going to be something that will take another five years to completely understand." According to the Journal, additional analyses from the WHI study, as well as breast cancer data from other countries, are expected to help explain the decrease (Wall Street Journal, 12/15).
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NIH: Scientist Pleads Guilty to Conflict-of-Interest Charge
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NIH scientist Trey Sunderland on Dec. 8 pleaded guilty to one misdemeanor charge for violation of federal conflict-of-interest rules, the Washington Post reports (Rich, Washington Post, 12/9). Federal prosecutors, who filed the charge on Dec. 4, in a "criminal information" document alleged that Sunderland -- the former chief of the geriatric psychiatry brand at the National Institute of Mental Health -- accepted $285,000 in consulting fees and other payments from Pfizer and failed to disclose the agreement properly. According to prosecutors, Pfizer from 1997 through 2004 paid Sunderland $285,000 in consulting fees for a project that studied biomarkers potentially linked with Alzheimer's disease. Prosecutors alleged that Sunderland in 1998 improperly entered an agreement with Pfizer to advise the company on the study of biomarkers in spinal fluid samples provided by NIH. The same year, NIMH and Pfizer entered a similar agreement to study biomarkers, and Sunderland entered a second agreement under which he received payments from the company, prosecutors alleged. "Sunderland initiated negotiations with Pfizer to be paid as a consultant for his work on the same project" as his NIH work, according to the document. Prosecutors alleged Sunderland violated NIH rules that require disclosure of income received from outside activities and of reimbursement by outside sources for travel expenses of more than $260. Sunderland also failed to disclose to NIH supervisors the nature of his outside activities and the payments he received, prosecutors alleged (American Health Line, 12/5).
Plea Agreement
Under the plea agreement, Sunderland would have to forfeit $300,000 in payments and reimbursements and perform 400 hours of community service (Dolan, Baltimore Sun, 12/9). In addition, Sunderland would receive probation for two years and would have to pay a fine of an indeterminate amount (Dominguez, AP/Philadelphia Inquirer, 12/9). U.S. District Judge J. Frederick Motz, who accepted the guilty plea from Sunderland, has final authority over his sentence, which he plans to issue on Dec. 22 (Baltimore Sun, 12/9). Attorney Robert Muse, who represents Sunderland, declined to comment on the case. NIH spokesperson Don Ralbovsky also declined to comment on the case. (Washington Post, 12/9).
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