Health Law

USA Today (1/16, Rubin) reports that while the Food and Drug Administration (FDA) "has identified certain types of medical devices, such as artificial hips, as 'presenting an unreasonably high risk to public health,' the agency continues to approve some after little more scrutiny than it gives blood pressure cuffs, according to a Government Accountability Office (GAO) report out Thursday." The report comes out a week after "a group of FDA doctors and scientists...wrote the Presidential Transition Team that managers in the agency division responsible for regulating devices 'have ignored the law and ordered physicians and scientists to assess medical devices employing unsound evaluation methods.'" The GAO report, combined with last week's letter and an Inspector General's report from earlier this week show "the FDA's Center for Devices is broken and needs a major overhaul," according to Diana Zuckerman, president of the National Research Center for Women & Families in Washington, D.C.

        The AP (1/16) adds, "Although Congress ordered the Food and Drug Administration years ago to resolve the issue, the agency approved 228 medical devices without a full scale review from 2003-2007," according to the GAO report. Some of these devices, including an external defibrillator, were "approved under the less rigorous process" and "have been recalled because of malfunctions and other problems."

        On its website, CNN (1/16) reports that the GAO recommended "immediate steps" by the FDA "to ensure that high-risk medical devices, such as external cardiac compressors, get approved through the agency's lengthy review process, not just cleared." UPI (1/16) also covers the story.

The AP (1/16, Haigh) reports that Connecticut Attorney General Richard Blumenthal filed suit in federal court Thursday seeking to overturn a rule issued by the Bush administration that "expands protections for doctors and other healthcare workers who refuse to participate in abortions and other medical procedures because of religious or moral objections," claiming that the rule "would trump state laws protecting women's access to birth control, reproductive health services, and emergency contraception.  Blumenthal said the regulations 'are flawed and defective,' and would 'unconstitutionally and unconscionably interfere with women's healthcare rights.'"  The AP notes that states which refuse to enforce the mandate risk forfeiting "all...funds" from the Department of Health and Human Services (HHS), and quotes HHS Secretary Mike Leavitt speaking in support of the measure last month.

        The Washington Post (1/16, A4, Stein) adds that Blumenthal's suit, and two others brought by "family planning groups," seeks "an immediate court order preventing the regulation from going into effect Tuesday and a permanent decision voiding the rule."  The Post lists the states involved in the suit, noting that the other suits were brought by Planned Parenthood and the ACLU on behalf of the National Family Planning and Reproductive Health Association.

        The Hill (1/16, Young) adds that HHS "issued the regulation last month, saying it is needed to protect healthcare workers against discrimination by their employers if they decline to participate in abortions or other practices that violate their religious, moral, or ethical beliefs.  But, President-elect Obama, leading congressional Democrats, and abortion-rights groups say the regulation goes too far, and would permit healthcare workers to deny women access to contraceptives and emergency contraceptives without referring them to alternative providers."

        CQ (1/15, Attias) also reports the story, adding that "critics say the regulation will make it easier for doctors to refuse patients access to contraceptive services, such as birth control, because the rule does not clearly define the term abortion."  CQ also notes that Secretary Leavitt has denied that contraception is a focus of the measure.  Instead, it is "intended to protect physicians' rights to practice according to their religious and moral beliefs."

The AP (1/16, Freking) reports that, according to a national survey conducted by the Kaiser Family Foundation and the Harvard School of Public Health, the "prospects for health reform drop significantly when Americans hear potential financial trade-offs associated with expanding health insurance coverage." The survey revealed that "nearly seven in 10 people say they favor the concept of" employer-sponsored health insurance, or "requiring employers...to contribute into a fund that pays to cover the uninsured." But, support fell "to about three in 10 people" when they "heard the mandate would cause some employers to lay off workers." Meanwhile, support for a mandate "requiring all Americans to have health insurance" fell from "two out of three people" to 19 percent when told "some people may be required to buy insurance that's too expensive."

        The survey, of "a random sample of 1,628 adults ages 18 and older," indicated that 43 percent rated "overhauling healthcare" as "a top concern" for the new president, "ranking it third behind" improving the economy and "fighting terrorism," CQ (1/16, Reichard) adds. But, 61 percent of respondents said that "given the serious economic problems...it is more important than ever to take on health reform." When asked to prioritize the nation's healthcare goals, 39 percent of those surveyed ranked affordability first, "followed by coverage expansion at 30 percent and improving quality and cost-effectiveness of the system at 18 percent."

Modern Healthcare (1/15, DoBias) reported, "Congressional leaders marked more than $87 billion in federal dollars to help states keep their Medicaid programs fiscally viable and another $27.1 billion for a raft of other healthcare provisions as part of an $825 billion spending and tax-cuts bill meant to lift the sagging national economy." Documents released by the House Appropriations Committee indicated that the spending package also includes "$3 billion aimed at prevention and wellness programs," as well as "$1.1 billion for comparative-effectiveness research; $1.5 billion in additional funding to the community health centers; and $600 million to help bolster the training and recruitment of primary-care physicians." Meanwhile, $550 million has been earmarked "to help modernize aging medical facilities."

        With regard to health information technology, the bill would appropriate "$20 billion overall...to prevent medial mistakes, provide better care to patients, and introduce cost-saving efficiencies," Government Health IT (1/15, Ferris) added. Of that total, $2 billion would go toward "the Office of the National Coordinator for Health IT in the Health and Human Services Department," while the remaining $18 billion might "be spent on health IT grants to states." The House committee is expected to take "action on the bill...next week," while "the Senate is said to be drafting its own language for the health IT portion of the bill."

Texas' Star-Telegram (1/15, Tinsley) reported, "Texas stands to gain more than any other state from the plan quickly making its way through Congress to boost the number of children who have health insurance." The plan, "approved by the House, and pending before the Senate," would "boost federal taxes on a pack of cigarettes from 39 cents to $1 to give four million more children health insurance." But, in doing so, the legislation "would raise the price of a single pack of cigarettes in Texas to around $6." And, while the state "has the highest percentage of uninsured children" in the nation, Texas also "has countless smokers, many of whom may be low-income themselves." Still, Fort Worth Mayor Mike Moncrief said that "this plan is needed" to "bring more money to Texas to help children stay healthy." He added that he hates "to place a burden on the backs of smokers," but believes "it's a legitimate place to put it."

The Long Island Newsday (1/15, Ochs) reports, "Long Island nurses, doctors, information specialists, hospital chiefs, advocates, healthcare policy wonks - they all came together and they had a lot to say, thank you very much. They had answered the call of President-elect Barack Obama and Health and Human Services Secretary nominee Tom Daschle, who asked that people nationwide meet in the last two weeks of the year to discuss how they would fix our ailing healthcare system. Two groups of Long Islanders responded." Newsday continues to relate the views of a number of local healthcare figures.

In an "Online Exclusive," the National Journal (1/15, Gilbert) reported, "The government has generally been slower than those it serves in embracing health IT, but there are signs of change," as "President-elect Barack Obama has pledged to spend $50 billion over the next five years on health IT, a commitment that experts applaud."  Some in the healthcare "community, however, are advising the transition team to approach any e-health initiative narrowly and methodically," yet "most agree that there are two areas where the government has a role to play: adoption and interoperability."  But, "a report released this week by Booz Allen Hamilton and the Federation of American Hospitals finds that electronic medical records alone won't necessarily cut costs or improve care unless that information can also be shared easily," and more providers get "on board."

Healthcare IT News (1/16, Monegain) reports that, according to Newt Gingrich, the founder of the Center for Health Transformation, "thousands of lives and an estimated $400 billion in healthcare spending could be saved by putting healthcare information technology to work and adopting best practices." In an online presentation on Wednesday, the former Republican Speaker of the House from Georgia "gave kudos to President-elect Barack Obama for his bipartisan approach" toward healthcare. Warning that "reform would have to be comprehensive," Gingrich said that he advocates "an approach that calls for improving individual health, creating a culture of health, and modernizing and improving delivery by moving from paper to digital processes. Insurance is the last piece." Gingrich called "interoperable electronic systems...critical to achieving 'breakthrough' change," but pointed out that "the focus" of healthcare reform "must be on best practices, data-driven healthcare, and reimbursement."

Modern Healthcare (1/15, DoBias) reported that the Centers for Medicare and Medicaid Services (CMS) "officially released three rules that halt Medicare payments when medical procedures are performed incorrectly, on the wrong patient or body part," in an effort to "reduce or eliminate their occurrence." The previous "two federal payment guidelines identified a number of so-called 'never events,'" including "injuries related to falls and traumatic events, foreign objects retained after surgeries, and blood incompatibility." In 2008, however, "both the American Hospital Association and the American Medical Association said that they were opposed to the use of the national coverage determinations as a means to halt payments for such medical errors," adding that "CMS needed to clarify" itself.

        The agency did so by releasing the final word on "surgical mistakes," which, according to MedPage Today (1/15, Gever), is joined by "12 categories of errors and preventable complications already on the CMS blacklist." Yet, "for those 12 errors...CMS is denying claims only for hospital inpatient reimbursements," whereas the "three surgical errors were the subject of National Coverage Determinations, meaning that the new rules apply to outpatient as well as inpatient procedures, and to individual physicians and other providers and suppliers, in addition to hospitals."

        CMS delays ICD-10 implementation requirement. In the Wall Street Journal (1/15) Health Blog, Sarah Rubenstein wrote, "Doctors are getting a two-year reprieve before they'll have to use the coding system known as ICD-10." Earlier this week, the Centers for Medicare and Medicaid Services (CMS) "put the finishing touches on the ICD-10, a new set that will allow for more specificity and precision in the way doctors and hospitals bill insurers for tests, procedures, and other types of care." Some "have worried about the cost...of adjusting to the new codes." But "after receiving more than 3,000 comments on its earlier ICD-10 proposal, the feds now say medical providers will have until Oct. 1, 2013, before they have to use ICD-10, rather than a prior proposal of Oct. 1, 2011."

The Palm Beach Post (FL) (1/16, Galewitz) reports, "Palm Beach County's hospitals are balking at paying a collective $1.1 million a year to ensure that residents seeking help at an emergency" department (ED) "have 24-hour access to a neurosurgeon." Area "hospitals have struggled for five years to get specialists such as neurosurgeons, hand surgeons, and gastroenterologists to handle emergencies." Consequently, "some Palm Beach County emergency patients have had to be transferred to hospitals as far away as Gainesville and Miami because of the lack of local specialists." That is why the "taxpayer-funded district last month put forward a financial plan to ensure emergency neurosurgery coverage countywide." But, "hospital officials say they should not have to bear most of the burden of providing the emergency coverage. Instead, funding also should come from sources such as county taxpayers, urgent care centers, and nursing homes."

In the last of a five-part series, the Scranton (PA) Times Tribune (1/15, Axelrod) reported, "Pennsylvania's largest Blue Cross and Blue Shield insurers project $892 million of cost savings in their first six years together if the state approves their proposed merger." The pending decision "could change the commonwealth's health insurance market for years." Those in favor of the deal "see consolidation among providers and insurers as an inevitable, positive step toward a more efficient U.S. healthcare system." In addition, officials from "Blue Shield operator Highmark Inc. of Pittsburgh and Philadelphia-based Independence Blue Cross", contend that "a merger wouldn't lessen competition because...the four Blues generally don't compete." Their assertion is supported by "a state-commissioned merger analysis by the consultant LECG Inc." Meanwhile, critics argue that the deal's benefits are being overestimated by Highmark and Independence. The report also "agreed with critics' claims that a merger could hurt other insurers' ability to enter Pennsylvania." A decision is "expected as soon as Jan. 27 by state Insurance Commissioner Joel Ario."

Life Sciences Law

The Wall Street Journal (1/16, Winstein) reports, "Johnson & Johnson won an important round in its long-running patent litigation over its heart stents, making it more likely that Boston Scientific Corp. will eventually have to pay J&J more than $700 million." Four years ago, "Boston Scientific persuaded a federal jury in Delaware that J&J's Cypher stent infringed a Boston Scientific patent, issued in 2000, on coating stents with drugs. Such coated stents help prevent arteries from reclogging after a stent is implanted."

        According to the AP (1/16), "Boston Scientific had claimed its two-layer drug coating was proprietary technology. However, justices on the appeals court said that patent was 'obvious and therefore invalid,' considering earlier technology."

        Bloomberg News (1/16, Decker) notes that Thursday's "ruling deals with one of two Boston Scientific patents that were found to be infringed by J&J. The other patent is still before the appeals court, as is Boston Scientific's appeal of a verdict it lost in a trial also held in 2005 in Delaware." MarketWatch (1/16, Witkowski), the Boston Business Journal (1/16), and Forbes (1/16, LaMotta) also cover the story.

The CBS Evening News (1/15, story 6, 2:05, Couric) reported, "Eli Lilly will pay out nearly $1.5 billion to end a criminal investigation of its marketing practices."

        Lilly "agreed to pay $1.42 billion to settle a probe into alleged improper marketing of the antipsychotic drug Zyprexa (olanzapine), the Justice Department said Thursday," the Wall Street Journal (1/16) adds. Lilly "said it will pay $800 million to settle civil suits, including $438 million to the federal government and $362 million to states." In addition, Lilly "will pay $615 million to resolve the criminal probe and plead guilty to a misdemeanor violation for promoting Zyprexa as a dementia treatment." The drug "is approved to treat schizophrenia and bipolar disorder."

        However, "court documents show Lilly sales representatives also pushed it to treat generalized sleep disorder, aggression, Alzheimer's-related dementia, and depression, among other unapproved uses, from 1999 through 2003," the AP (1/16, Murphy and Seaman) notes. Bloomberg News (1/16, Fisk, O'Reilly) also covers the story.

Bloomberg News (1/16, Pearson, Bloodsworth) reports that, according to the testimony of endocrinologist Jennifer Marks, M.D., "AstraZeneca PLC's antipsychotic" medication "Seroquel (Quetiapine) raised by almost 400 percent the risk of developing diabetes when compared with first-generation medications in its class." During a pretrial hearing Thursday, Dr. Marks "testified on behalf of former Seroquel user Linda Guinn," who "blames Seroquel for her Feb. 2006 diabetes diagnosis." Dr. Marks cited a "2004 article published in Psychiatric Services, a journal of the American Psychiatric Association," which "reported the increased risk in males who were exposed to Seroquel for at least 60 days," as well as other "studies bolstering her opinion that Seroquel causes diabetes." Attorneys for AstraZeneca, however, "attribute Guinn's diabetes to obesity, a family history of the disease, and hypertension." The "case is In re Seroquel Products Litigation, 06-01769, U.S. District Court, Middle District of Florida (Orlando)."

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