Obama begins push for healthcare reform with White House summit.
NBC Nightly News (3/5, story 3, 2:50, Todd) reported that "Obama began his effort to reform the massive and complicated healthcare system, tying it to the economic crisis." Obama said, "It's one of the greatest threats not just to the well-being of our families and the prosperity of our businesses, but to the very foundation of our economy. And that's the exploding costs of healthcare in America today." NBC went on to report that "drawing on a lesson from Hillary Clinton's failed attempt to deal with healthcare in the early '90s, which was criticized for its secrecy...Obama opened up the process, inviting doctors, patients, business and labor leaders, even live streaming discussion groups on a new website, healthreform.gov." The CBS Evening News (3/5, story 6, 2:50, Couric) noted that the President contended "you can't fix the economy without fixing the healthccare system," adding (Reid) that he "boldly predicted quick success where so many before him have failed." Obama was shown saying, "Our goal will be to enact comprehensive healthcare reform by the end of this year." ABC World News (3/5, story 3, 2:30, Gibson) also covered the story.
The Wall Street Journal (3/6, Meckler) reports, "The sessions, which were open to the press and shown live on C-Span and the Internet, were in contrast to the approach" under Clinton, whose plan "was developed behind closed doors." Obama "appears to have learned another lesson from the Clinton administration's failed attempt, as shown by his promise that people who like their existing insurance plan would be able to keep it. One concern some had with the Clinton plan was that people might have to change their existing plans." The President is also "working to appeal to those who already have insurance by emphasizing that their costs would fall under his plan."
AFP (3/6, Collinson) also reports that "under the White House healthcare plan, which will likely be amended by lawmakers in final legislation, Americans who have health insurance and want to keep it can do so, though the administration says costs will lower." The plan would also "seek to lower the cost of prescription drugs, partly through relaxing rules on the import of medicines from other developed nations, and stop pharmaceutical giants blocking production of generic treatments."
According to the New York Times (3/6, A14, Pear, Stolberg), Obama "indicated for the first time that he was open to compromise on details of the proposal he put forth in the 2008 campaign. ... As a candidate, Mr. Obama said he would establish a public insurance program to compete with private insurers and would require employers to contribute to the cost of coverage for their employees or to the cost of the public plan. Insurers oppose the idea of a new public plan." The Times adds that "since the election, Mr. Obama has not restated the details of his campaign proposal, and he indicated Thursday that he would be pragmatic."
USA Today (3/6, Wolf) reports that "White House session...brought disparate factions together," and "Obama elicited promises of cooperation from lawmakers and stakeholders who in the past have been at loggerheads over how to fix the system. He and others emphasized areas of agreement and said they would work amicably on their differences." The summit "was notable for bringing interest groups together under one roof." USA Today adds that "insurers played the leading role in killing a healthcare overhaul in 1994, a point Obama noted."
The AP (3/6, Alonso-Zaldivar) reports, "The difference this time, Obama says, is that healthcare costs have become unsustainable, particularly in a sinking economy. The US spends $2.4 trillion a year on healthcare. Obama's goal is health coverage for everyone." The Washington Post (3/6, A2, Connolly), the Chicago Tribune (3/6, Levey), The Hill (3/6, Young), the Christian Science Monitor (3/6, Marks), the Financial Times (3/6, A1, Ward), Bloomberg News (3/6, Goldstein), UPI (3/6) and the Guardian (UK) (3/6) also cover the summit.
Employment and Labor
Delphi retirees appealing court ruling allowing termination of health benefits.
The AP (3/6) reports, "Attorneys representing a group of Delphi Corp.'s salaried retirees are appealing a bankruptcy judge's approval of the auto supplier's request to stop paying for their healthcare and insurance benefits." Notably, "in court filings with the US Bankuptcy Court in Manhattan, law firms representing the Delphi Salaried Retirees Association ask that the appeal of Bankruptcy Judge Robert Drain's decision be heard by the US District Court for the Southern District of New York." Last week, Judge Drain "gave provisional approval to Delphi's request to terminate the benefits effective April 1 at a hearing...saying that Delphi has a right to amend the retirees' benefits. Drain will make a final ruling on Delphi's request at a March 11 hearing."
In its appeal, the group is arguing that "Delphi didn't have authority to cancel the benefits, and that affected workers should have been permitted to form a committee to offer greater input on the proposal," Bloomberg News (3/6, Larson) notes. In addition, Kelly Woodruff, a lawyer for the group representing more than 2,000 retirees, said, "We need something less devastating for retirees living on fixed incomes. ... There are 15,000 retirees whose benefits are about to disappear without an opportunity to negotiate something less than a full-blown termination." Meanwhile, "Delphi says the planned cuts will save $70 million a year and eliminate $1.1 billion of debt." In response, "Woodruff said she understands the company's well-being is in danger, and that some changes to benefits may be needed."
Federal Agency News
CNN's Gupta withdraws name from consideration for surgeon general post.
The Washington Post (3/6, A2, Shear, Kurtz) reports, "Sanjay Gupta, CNN's chief medical correspondent, has told network officials that he will not leave his television career to become the US surgeon general, according to sources familiar with his decision." Gupta "withdrew his name even as President Obama hosted a healthcare summit at the White House that Gupta did not attend." As a result, the "often low-profile job will not get the mass-media jolt from appointing the TV celebrity."
CNN (3/6) reports that Gupta told CNN's Larry King, "This is more about my family and my surgical career. ... I think, for me, it really came down to a sense of timing more than anything else. I just didn't feel I should do that now."
The AP (3/6) reports that Dr. Gupta "was sought after" because he would "have brought star power to the office of surgeon general, which has lacked visibility since the days of C. Everett Koop in the Reagan administration." The Surgeon General is a "bully pulpit for promoting improvements in public health."
The New York Times (3/6, A18, Harris) reports that Gupta's wife "is expecting a child, and Dr. Gupta wants to spend more time with his family and continue practicing medicine and serving as a CNN correspondent, the CNN anchor Wolf Blitzer said on Thursday." Besides his duties on CNN, Dr. Gupta "presides over a small media empire that includes appearances on the 'CBS Evening News' and columns in Time magazine."
FOX News (3/6) reports that in spite of his high profile, "some had concerns about his credentials." In the House of Representatives, Judiciary Committee Chairman John Conyers "urged colleagues to oppose the nomination because Gupta lacks the 'requisite experience' for the job." However, because the surgeon general "comes for confirmation before the Senate, not the House... Conyers' objections probably did not have much bearing on the process."
The Chicago Tribune (3/6, Dorning) notes that "Obama Administration officials" are attributing Gupta's decision "to personal considerations amid a campaign by some liberal interest groups to block his selection." His "selection quickly aroused opposition. Some groups cited his critical reporting on government-run healthcare systems. And some liberal physicians raised the possibility of conflict of interest because Gupta had participated in television programming on a health channel for doctors offices. The programming was partly underwritten by drug companies." The Washington Times (3/6), UPI (3/6), AFP (3/6), Scientific American (3/6, Stein), and the UK's Telegraph (3/6, Shipman) also cover the story.
FDA warns some drug patches may cause burns during MRI.
The Wall Street Journal (3/6, Dooren) reports that the "US Food and Drug Administration Thursday warned of the risk of skin burns in patients wearing transdermal drug patches who are undergoing MRI scans." The patches, which "are applied to the skin and can be used to deliver pain medications, hormones, and nicotine," are made with "aluminum or other metal in the backing of the patches which can overheat during an MRI scan and cause skin burns in the immediate area of the patch."
According to the New York Times (3/6, A18, Harris), the FDA said it "has received reports of as many as five patients wearing patches who experienced a skin burn similar to a bad sunburn during screening. ... Federal health officials are generally alerted to only a fraction of the injuries associated with drug and device use." The transdermal "patch alert is the latest in a string of safety warnings involving magnetic resonance imaging that have resulted from the unpredictable effects of the strong magnets used in MRI devices." Currently, radiologists "warn patients with tattoos, implanted medical devices, and shrapnel that they could experience discomfort or injury when scanned."
Dr. Sandra Kweder, deputy director of the Office of New Drugs at FDA's Center for Drug Evaluation and Research, said that "there are a total of 60 medication patches on the market, and about 25 percent contain metal," HealthDay (3/5, Reinberg) reported.
The AP (3/6, Neergaard) notes, "As for patch makers, FDA is reviewing every product's label to be sure ones that are supposed to carry the safety warning do. Some may be missing because a patch was reformulated to add metal after its label was written; other times, FDA acknowledged it just didn't ensure the warning was present in the first place." The agency is also "considering having an MRI warning somehow be put on the individual patch, not just the box it comes in."
UPI (3/5) added that the FDA's recommendation tells "people wearing medicated skin patches, including nicotine patches, [to] talk to a healthcare professional about their patch at the time they receive their MRI referral." Additionally, patients should "tell their MRI facility they are using a patch when they call to schedule their appointment, and repeat that information when filling out their health history questionnaire after arriving for their appointment." WebMD (3/5, Hitti) and Medscape (3/5, Lowry) also covered the story.
Watchdogs unfazed by DeParle's ties to healthcare industry.
The Hill (3/6, Young) reports, "White House Office of Health Reform Director Nancy-Ann DeParle's professional ties to healthcare companies may have prompted questions from the media, but government ethics watchdogs say they don't see a problem." She "brings stellar credentials to her new job" and "can boast of a top-tier educational background," according to The Hill. Skadden, Arps, Slate, Meagher & Flom partner Kenneth Gross, an expert on ethics, said, "My fundamental premise is that I don't think we should get into the business of disqualifying people because they've been on the 'other side.'"
DeParle resigns from Cerner board of directors. In a brief story, the Kansas City Business Journal (3/6) reports, "Nancy-Ann DeParle has resigned from Cerner Corp.'s board of directors after President Obama named her as director of the White House Office of Health Care Reform."
General Health Law
Editorials discuss Wyeth ruling, weigh in on likely effects.
The Boston Globe (3/6) editorializes, "When the Supreme Court upheld a $6.7 million award Wednesday to a Vermont woman who lost an arm in a botched drug injection, the verdict went against not just the drugmaker but also the Food and Drug Administration." The Court's 6 to 3 decision "sends two messages. It tells President Obama that he can waste no time fulfilling his pledge to strengthen the FDA" and "the ruling tells the pharmaceutical industry that it bears final responsibility for the way its products are made and administered." Concluding, the Globe says, "Critics of the court's Levine decision worry that it will cause pharmaceutical companies to steer away from innovative drugs in favor of modest improvements to existing medications." However, that doesn't have to be the effect "if companies would test their new medications more thoroughly before bringing them to market, and then do a better job of monitoring adverse events and reacting to them decisively."
USA Today (3/6) editorializes, "Wyeth argued it was immune from liability because it had met the FDA's requirements" but the "Supreme Court disagreed, ruling that state laws do not interfere with FDA rules but are meant to enhance them." The ruling may have wide ranging effects as "many industries have spent millions on lobbying and campaign contributions to achieve this 'federal pre-emption,' often finding a sympathetic ear from Republicans who otherwise champion 'states' rights.'" USA Today notes, "Now that the court has ruled, states should allow suits but set a high burden of proof on the plaintiffs. They shouldn't be able to collect unless they can demonstrate that a manufacturer deceived regulators or otherwise acted negligently." USA Today concludes, "That sort of balance should protect the interests of companies and consumers alike."
In the USA Today's (3/6) opposing view blog, Bert Rein, partner at Wiley Rein and of counsel to Wyeth in the Levine case, writes, "Congress created federal public health agencies such as the Food and Drug Administration (FDA) because it takes experts to consider the complexities and the risks and benefits of prescription drugs and medical devices." He says, "By permitting lay juries to second-guess the FDA's decisions on what options doctors should have available in administering prescription drugs, the Supreme Court's decision in Wyeth v. Levine creates uncertainty for patients and doctors by placing the experience of a single patient above the public health interests of everyone." He concludes, "Federal regulators might not always get it right, but I would certainly prefer to ride with their expert judgment than to have my access to prescription drugs, or other federally regulated products, dictated by a process of lay jury trial."
Healthcare Policy/Legislation
Birth of octuplets inspires legislation regulating fertility clinics, human embryos.
The Los Angeles Times (3/5, Yoshino, Garrison) reported that some "anti-abortion groups in Georgia are using [octuplet mom Nadya] Suleman's story as a rallying call to enact stricter rules to govern the $3-billion fertility industry, which has some doctors worrying that the octuplets may be used as a pretense to pass laws restricting abortion rights." Legislation has also been proposed in California and Missouri "that critics say might create a confusing patchwork of regulations." In Missouri, a new bill "seeks to adopt industry standards as law. The California law gives the state Medical Board oversight of fertility clinics." The Georgia bill, meanwhile, "defines an embryo as a 'biological human being' and prohibits the destruction of frozen embryos -- wading into a loaded debate over abortion rights and embryonic stem cells." Experts say that unless the fertility "industry is careful, the country could end up with a mishmash of policies that forces patients to doctor shop from state to state in search of laws most favorable to their needs." One organization "called this week for congressional hearings, noting that federal oversight is the best solution."
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Autism insurance mandate passes Missouri House.
The AP (3/6) reports that "Missouri lawmakers have taken a first step toward a mandate [to have insurers cover autism], which insurance companies claim could have a side effect of driving up insurance costs for everyone." On Wednesday, a Missouri House committee "endorsed legislation requiring group health insurance plans to cover up to $72,000 annually of autism services for children younger than 11. Insurers would have to cover up to $36,000 annually for people 11 to 21." The endorsement "came a day after a Senate committee endorsed legislation mandating childhood autism coverage that would apply to an even broader array of insurance providers." Estimates for how much the legislation would raise health insurance premiums range from less than one percent to three percent, but insurance lobbyists say that the "Missouri Senate bill could cost the insurance industry -- and their customers -- more than $200 million," and argue "that if autism coverage is a priority for legislators, then they ought to find state money to cover it."
North Dakota House defeats healthcare rights amendment.
The AP (3/6, Wetzel) reports, "North Dakota's House voted down a proposed constitutional amendment on healthcare rights, concluding it may not accomplish its purpose of assuring the availability of private medical services." The measure aims to "bar the Legislature from approving any law 'that restricts an individual's freedom of choice of private healthcare systems or private plans of any type...(or) a law that interferes with a person's right to pay directly for lawful medical services.'" Kasper stated that "he was concerned that federal universal healthcare legislation might hamper North Dakotans' rights to obtain private healthcare." But, "representatives voted 77-16 on Wednesday to defeat the proposed amendment. There was no debate."
Health Information Technology
Collaboration to recommend rules easing interstate transfer of electronic health information.
Government Health IT (3/6, Ferris) reports that the federally funded 11-state Interstate Disclosure and Patient Consent Requirements Collaborative "will recommend creation of a rules engine this month to facilitate the exchange of patients' electronic health information across state lines." The rules engine "would determine what privacy and consent laws apply to a given transfer of information and report those findings, thereby simplifying the process of obeying disparate state laws and rules governing health information." The collaborative is "part of the Health Information Security and Privacy Collaboration (HISPC), which has been working since 2005 to overcome the barriers created by differing state laws and regulations." Experts have said that "uncertainty about the applicability of other states' laws and lack of knowledge of those laws has hampered the interstate exchange of health information and could keep the Nationwide Health Information Network from achieving its potential." The collaboration's "recommendation will be included in [its] report due at the end of March as the HISPC project comes to a close."
Insurance and Managed Care
CDPHP, Excellus to stop using database that charges more for out-of-network services.
The AP (3/6, Bauman) reports that the Capital District Physicians' Health Plan [CDPHP] and Excellus have reached an agreement with the New York Attorney General "to stop using a faulty database that cost patients more when they used doctors outside of their plan's network." The health insurance companies "will stop processing claims through the Ingenix database, a flawed system used to calculate consumer reimbursements for treatment." According to the AG, Ingenix, "as a subsidiary of UnitedHealth Group...had an interest in helping set rates low so companies could underpay patients for out-of-network services."
Medical Devices
Democrats introduce legislation to reverse Supreme Court ruling on medical-device lawsuits.
The AP (3/6, Perrone) reports that one "day after the Supreme Court decided that federal rules do not protect drugmakers from state lawsuits," Democratic lawmakers "reintroduced a bill that would allow similar lawsuits against companies that make heart devices, catheters, hip replacements and other devices." In 2008, "the Supreme Court agreed with the pre-emption policy in a case [Riegel v. Medtronic] involving medical devices, ruling a patient injured by a catheter from Medtronic could not sue under state laws. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices," but "there's no similar provision for drugs." Rep. Frank Pallone (D-NJ) "and other Democrats said...that decision ignored decades of precedent." The AP adds that "the bill to restore liability claims against device makers is co-sponsored by Rep. Henry Waxman (D-CA)," who "is expected to hold hearings on the issue in coming weeks."
The Wall Street Journal (3/5) Health Blog reports that "the proposed legislation was long expected, even more so after the Supreme Court's ruling yesterday seemed to create different rules for drug and device manufacturers." But, "the question now is whether the bills have enough votes to pass. Similar legislation failed last year, although it may have better odds now as a result of the Democrats' election gains."
Dow Jones Newswires (3/6, Favole) reports that "Waxman and Pallone said the Riegel v. Medtronic decision has left consumers without ways to seek compensation for injuries, medical expenses and lost wages caused by defective premarket approval devices or inadequate safety warnings."
Pharmaceuticals
Statements allege J&J pushed reps to promote Risperdal for off-label uses.
Bloomberg News (3/6, Fisk, Voreacos) reports, "Johnson & Johnson's Janssen Pharmaceutica unit pushed sales representatives to promote its antipsychotic drug Risperdal (risperidone) for uses not approved by regulators, three former salespeople said in a lawsuit against the company." The company "tried to promote Risperdal for conditions beyond schizophrenia, its approved use until December 2003, according to sworn statements among almost 1,000 pages of documents in the case in Trenton, New Jersey."
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