Health Law

Bloomberg News (2/5, O'Reilly) reports, "Pfizer, Inc.'s Pharmacia unit used 'inflated and phony' price reporting to illegally overcharge Wisconsin's Medicaid program for decades, and should be made to pay damages, an attorney for the state said." During "opening arguments [Wendesday] at a trial of the state's lawsuit against Pharmacia in Madison, Wisconsin, attorney Jeffrey Archibald said the company's reported average wholesale prices, known as AWP, much higher than what pharmacists in the state were actually paying for drugs from 1975 to 2005." This case "is the latest round of litigation over the AWP system. At least 27 states have sued dozens of drugmakers over the practice, with Alabama having already secured jury verdicts worth about $330 million against three companies."

McClatchy Newspapers (2/5, Kraske) focuses on Kansas Gov. Kathleen Sebelius' (D) prospects for being nominated to lead the Department of Health and Human Services (HHS), saying she "emerged Wednesday as a leading candidate for the Cabinet post of secretary of" HHS. Sebelius' office has "declined to end speculation that she might be interested in the job" by not commenting on her possible interest. Yet, "leaving her post as governor would be tricky, coming as it would less than two months after she withdrew from consideration for Obama's Cabinet on Dec. 6. At the time, she said she wanted to focus on state spending 'given the extraordinary budget challenges facing our state.'" McClatchy also adds former Sen. Bill Bradley (D-NJ) to the list of names of other possible HHS Secretary candidates already mentioned in the press.

        Modern Healthcare (2/5, DoBias) notes that among those being considered to lead HHS, "One recurring name, Kansas Gov. Kathleen Sebelius, surfaced early on during Obama's campaign as a possible vice president pick."

        Time (2/5 Tumulty) reports the White House "is focusing initially on a group of current and former governors as possible candidates to replace Tom Daschle." Obama "aides believe that the crop of current and former Democratic governors provide some possible candidates who have the right credentials." Time adds Pennsylvania Governor Ed Rendell (D) and Tennessee Governor Phil Bredesen (D) to the list of possible candidates. The Wall Street Journal (2/4, Rubenstein) Health Blog also covered the story.

The Wall Street Journal (2/5, Landro) reports, "Unsafe injection practices are one of the leading causes of infections in doctors' offices, outpatient clinics and long-term-care facilities, according to" the CDC. Although most healthcare workers "are aware of the dangers of reusing needles, other injection guidelines aren't always followed, including disposing of syringes after each use. Contaminated shots can lead to transmission of such diseases as hepatitis and HIV, along with other viral and bacterial infections." The CDC and private medical groups next week "plan to kick off an educational campaign with the slogan, 'One Needle, One Syringe, Only One Time.'" Diseases like HIV and hepatitis "can be transmitted if an infected person is given a shot and either the syringe or needle is then reused. Even microscopic backflow into the syringe from the infected person can contaminate it."

The AP (2/5, Perrone) reports that the Food and Drug Administration (FDA) is looking into evidence that Xigris (drotrecogin alfa), "used to treat blood poisoning, worsens the risk of bleeding and can lead to death in certain patients." The FDA said "a recently published study showed that...Xigris increased the risk of dangerous internal bleeding when used by patients with a recent history of hemorrhages." For the study, published in the journal Critical Care Medicine, researchers "looked at 73 sepsis patients who were treated with Xigris." They "found that serious internal bleeding occurred in 35 percent of patients who had risk factors for internal bleeding, compared with 3.8 percent of patients who did not. More patients with bleeding risk factors died compared with patients who did not have those risks."

        The FDA noted that the study's researchers "acknowledged that their study had a number of limitations including the small size of the sample population, which made it difficult to 'draw definitive conclusions from the data,'" MedPage Today (2/4, Peck) added. The FDA pointed out that "the drotrecogin prescribing information already contains warnings about baseline bleeding risks under the 'Warnings and Precautions' section of the package insert." Still, the agency "said it was 'working with the manufacturer to further evaluate the incidence of serious bleeding events and mortality in patients who received [drotrecogin].'"

HealthDay (2/4, Reinberg) reported, "In a continuing effort to prevent counterfeit and adulterated medications from reaching American consumers, the U.S. Food and Drug Administration [FDA] is adopting stricter standards for heparin and glycerin -- two widely used drug products at the center of recent contamination episodes." The new standard, created by the U.S. Pharmacopeia (USP) Convention, "includes a specific chemical identification of heparin that spots the chemicals in the heparin more precisely than was done before," said USP Chief Science Officer Dr. Darrell R. Abernethy. The change will take effect in August. In addition, "the FDA asked the USP to improve the standard for glycerin, to exclude ethylene glycol or diethylene glycol from glycerin." Currently, "manufacturers [are] only required to spot test their products for these chemicals." Beginning in May, "manufacturers will have to test for these chemicals in all the glycerin that comes into their plants."

The AP (2/5) reports, "Eli Lilly & Co.'s blood thinner prasugrel, which won a strong endorsement from a panel of health experts Tuesday, could surpass $1 billion in annual sales within a few years, according to analysts." Seamus Fernandez, an analyst with Leerink Swann, "projects global revenue of $1.15 billion in 2013 and $1.6 billion in 2015 for prasugrel." Catherine Arnold, an analyst Credit Suisse, "predicted that global sales will reach $1 billion by 2012 and surpass $2.15 billion in 2015." A Food and Drug Administration advisory panel voted unanimously this week to recommend approval of prasugrel. The agency "still must decide whether to approve it and has set no timeframe for the decision." The FDA "has twice delayed making a decision on the drug and is not required to follow the advice of the panel, though it usually does."

Bloomberg News (2/5, Marcus) reports, "House Republicans formed a health team to counter the Democratic majority's plans to expand government- run U.S. healthcare programs."  This "task force, headed by Representative Roy Blunt of Missouri, will offer proposals that avoid creating a new 'government-dominated healthcare bureaucracy,' House Republican leader John Boehner, of Ohio, said today in an emailed statement."

        CongressDaily (2/5) adds, "Boehner also named 15 other Republican lawmakers to the task force, including Energy and Commerce ranking member Joe Barton, Education and Labor ranking member Howard (Buck) McKeon, Budget ranking member Paul Ryan, and Ways and Means ranking member Dave Camp."

The Wall Street Journal (2/5, B4, Vascellaro, Bulkeley) reports that "Google Inc., moving to improve its online health-record service, is teaming with International Business Machines Corp. (IBM) to allow patients to add data generated from home-health monitoring products, such as blood-pressure cuffs and glucose meters." Google and IBM "said software developed by IBM, with consumers' permission, can shift the data into a personal health record in Google Health, the search giant's service for helping consumers manage and store their health information online." Meanwhile, "other software lets the patient transfer the information from there to an electronic medical record kept by providers like healthcare companies and primary-care physicians." Sameer Samat, director of Google Health, said, "The new IBM partnership, he said, will help consumers round out their medical records with daily health information, like their blood pressure, that is often difficult to organize."

The Wall Street Journal (2/5, McQueen) reports, "A string of recent legal settlements with big health insurers may allow some participants in managed-care plans to begin recovering some of the money they may have overpaid for using out-of-network doctors and hospitals." Health insurance companies "UnitedHealth Group Inc., Aetna Inc. and Health Net Inc. have agreed to make millions of dollars in funds available to patients and, in some cases, physicians for possibly having shortchanged them in the past." And, "a number of other legal actions are pending that seek redress for patients and healthcare providers who claim they were underpaid by insurers for out-of-network services." According to the Journal, "the legal settlements represent the latest chapter in a long-standing battle over insurance-company payouts." The suits "were filed on behalf of physicians and patients who claimed they were inadequately reimbursed for out-of-network services." But, "insurers have long defended how they calculate such payments, which are known as usual-and-customary fees and are often derived from a database of medical-claims information."

        MVP Health Care agrees to pay $535,000 to resolve inquiry into out-of-network reimbursements. The New York Times /Bloomberg News (2/5, B9) reports, "MVP Health Care agreed on Wednesday to pay $535,000 to resolve a New York State inquiry into how it reimburses clients for services from out-of-network physicians." The nonprofit insurer "is at least the third insurer to cut a deal with the state over the way it determines charges for reimbursement." One of the other insurers, Capital District Physicians' Health Plan, has not yet settled, but UnitedHealth Group has "agreed to shut the database operated by its Ingenix unit, which insurers used to help determine reasonable and customary costs for out-of-network claims." MVP Health Care's "payment will help pay for a nonprofit entity to run an independent database." For the database, UnitedHealth also "agreed to pay $50 million, and Aetna said it would pay $20 million."

The Florida Times-Union (2/5, Larrabee) reports, "Almost 37,000 Duval County Medicaid patients will have to find a new healthcare plan by May 1, when WellCare will stop offering coverage under the state's reform pilot program." The insurer's "withdrawal is the latest blow to former Gov. Jeb Bush's reform initiative," according to the Times-Union. Under the initiative, "Medicaid patients in five pilot counties receive credits for healthy behaviors; those credits can then be used to buy health and hygiene products. The state also adjusts its payments to HMOs based on how many of its customers are healthy and less likely to need medical attention." Florida Association of Health Plans President Michael Garner "said he couldn't speak specifically to WellCare's decision, but pointed out that the state cut Medicaid reimbursement rates 3 percent in September and another 3 percent during the special legislative session last month." In fact, "Medicaid HMOs turned a 0.36 percent profit statewide in the third quarter of 2008, the sixth consecutive quarter in which profits declined."

        The Miami Herald (2/4, Caputo) added that despite WellCare's pull from the pilot program, the insurer's "78,000 Medicaid Reform clients -- 41,000 of whom are in Broward County --- will still receive state-paid health services but through another health plan, according to the Agency for Health Care Administration (AHCA)." WellCare "plans to continue participation in the state's main Medicaid program, which has slightly higher rates for providers." The St. Petersburg Times (2/4) also covered the story.

The Buffalo (NY) News (2/4, Davis) reported, "Doctors and insurance companies often argue over who should determine when care is medically necessary," and "it's a problem" that has been "illustrated by a dispute that puts patients in the middle of a disagreement between a Buffalo doctor and BlueCross BlueShield of Western New York over a medication for Crohn's disease." At present, the "health insurer covers the cost of" 6-mercaptopurine, or 6-MP, "but it will not cover one of the tests physicians want to use to monitor the medication in patients," explaining that "the test remains investigational and that research so far does not indicate it is more effective than routine blood work." Physicians say, however, that metabolite testing "can help determine the optimum dose and avoid potential toxic side effects," and "the current position of the American Gastroenterological Association is that metabolite monitoring may be helpful for determining the best dose of medication." Notably, the "metabolite monitoring...is done by only one company, Prometheus Laboratories," for "around $400."

Healthcare IT News (2/4, Merrill) reported that "UnitedHealth Group has adopted new standards for healthcare ID cards across all its health plans." These "cards will provide patient eligibility information and access to a personal health record, and process healthcare transactions." These "new national standards require healthcare ID cards to include a magnetic stripe that can be read through a standard card-reader machine, and also be designed with a standard layout to increase readability and be compliant with the National Council for Prescription Programs." According to officials, "this will give physicians and other care providers simpler access to more real-time information about their patients, while also advancing a single data platform for healthcare ID cards industrywide."

The UK's Daily Mail (2/5) reports, "Six cancer victims whose sperm samples were destroyed when a hospital freezer broke can sue the NHS trust for compensation, a judge has ruled." The plaintiffs had their sperm frozen after being "diagnosed with cancer in 2002" fearing that "chemotherapy might make them infertile." Their samples were to remain frozen "for free for ten years to give the men a chance of having children," but "the liquid nitrogen in one of the long-term freezer tanks at Bristol's Southmead Hospital fell...and the samples of 28 men thawed out."

        The Court of Appeals ruled "that the sperm samples...were the men's property and they could claim damages for the loss," the UK's Scotsmen (2/5, Moss) notes. According to Lord Justice Wilson, "the men had argued that the loss of the samples meant they would be likely to suffer a 'severe adverse reaction' unless they were able to recover their fertility." And, although the court "agreed the loss was not a personal injury," it noted that "the hospital unit had chosen to take and store the sperm and had given the men assurances." But, "the hospital had broken that promise," Lord Justice Wilson pointed out.

        The ruling overturned a "county court judgment in favour of the NHS trust," and "opens the door for the men to claim for psychiatric injury or mental distress at a later date at Exeter County Court," the UK's Independent (2/5, Verkaik) adds. Lord Chief Justice, Lord Judge, the most senior judge in England and Wales, stated that "the appeals raise interesting questions about the application of common law principles to the ever-expanding frontiers of medical science." For its part, "the hospital denied liability, saying the samples were not property in the legal sense." The UK's Telegraph (2/5, Smith) and BBC News (2/4) also covered the story.

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