Health Law

The Chicago Tribune (2/8, Roe), briefly assesses the one-to-five star system used by the federal Centers for Medicare & Medicaid Services (CMS) to rate facilities that accept Medicare or Medicaid funds. The Tribune notes that "Many nursing home officials -- and consumer advocates -- assail the star system for rating the facilities. Administrators say the ratings are too simplistic. Advocates fear some five-star homes are overrated and may give consumers false comfort." But the agency says that the ratings, based on inspections and investigations of complaints, as well as some self-reported data, use a complex formula that adequately adjusts for differences among facilities, such as the types of patients they serve.

The AP (2/9) reports, "Kansas Gov. Kathleen Sebelius is near the top of President Barack Obama's list of candidates to head the Health and Human Services Department at least partially on the strength of her long and close working relationship with the president, a senior administration official said." The AP notes that such candidates as Clinton White House Chief of Staff John Podesta "remain in the mix," adding that an anonymous source said Obama is unlikely to announce his decision soon. The piece notes that Sebelius' name has been floated for a cabinet position since Obama's election, but adds that she has expressed an unwillingness to leave her governorship.

        CNN (2/9) adds that according to unnamed officials, Sebelius "recently met with senior White House adviser Valerie Jarrett," painting this as a sign that she is "getting a close look" for the post. "Sebelius has a good personal relationship with the President and remained in the running for the vice presidential slot until near the end of the process, the officials also told CNN." Others "getting a look include Oregon Democrat Sen. Ron Wyden and Tennessee's Democratic Gov. Phil Bredesen, according to the officials." ABC News (2/8) and The Politico (2/9, Allen) also covered the story.

The Wall Street Journal (2/8, Zhang) reported that after "President Barack Obama cited his concerns as a public official and a father" and "called this past week for a complete review of Food and Drug Administration operations," lawmakers in the House and Senate renewed their own calls for reform, adding the latest outbreak to the list of "food-poisoning cases in recent years involving bagged spinach, lettuce, tomatoes, wheat flour from China and hot peppers from Mexico." Of the competing plans in the works, Senator Dick Durbin "plans to introduce legislation that would give the FDA authority to order food recalls and set safety standards for fresh fruits and vegetables." Rep. Bart Stupak is "pushing a bill that would fund FDA inspections with fees from food companies and increase penalties for safety violations." Rep. Rosa L. DeLauro, who chairs the House Appropriations Committee panel, "introduced legislation Wednesday to split the FDA into two agencies, one for food safety, the other regulating drugs and medical devices."

Bloomberg News (2/7, Nussbaum) reported that the Food and Drug Administration (FDA) has approved J&J unit Biosense Webster's "NaviStar ThermoCool and EZ Steer ThermoCool Nav as the first minimally invasive tools to ablate, or kill, the cells that trigger atrial fibrillation." Bloomberg pointed out that "EZ Steer is a bi-directional version of the NaviStar catheter."

        Dow Jones Newswires (2/7, Dooren, Kamp) reported that "the device was previously approved in the U.S. for atrial flutter, another type of heart-rhythm problem." While "this marks the first U.S. approval for a company to market catheters for atrial fibrillation, it is becoming an increasingly common practice with devices already approved for other uses." Although "drugs are the typical treatment...they frequently don't help, and there is an expanding market for medical devices that carefully destroy heart tissue linked to the problem." Dow Jones added that "systems like the Biosense Webster device use catheters that are inserted through a blood vessel and guided to the heart, where they deliver a radio-frequency current to burn, or ablate, tissue."

        MedPage Today (2/6, Gever) and the AP (2/7) also covered the story.

The Washington Post (2/7, B2, Dvorak) reported, "A federal judge scolded the District's attorney general in court yesterday and told him that the city's child welfare agency is not ready to stand on its own. 'I don't understand your approach today, coming in and throwing down the gauntlet,' U.S. District Judge Thomas F. Hogan told D.C. Attorney General Peter Nickles, who last week sought to put an end to 20 years of court involvement in the D.C. Child and Family Services Agency by filing a flurry of legal briefs. CFSA went into a five-year federal receivership in 1995 and has since been under court supervision. When city officials filed a six-month reform plan without the approval of the court-appointed monitor last week, they sidestepped one of those terms, signaling the start of a legal battle."

Bloomberg News (2/6, Doherty) reported, "Roche Holding AG...may make its first acquisition of a Chinese biotechnology company or buy rights to a compound developed in the country later this year." Lee Babiss, the head of Global Pharma Research at Roche, explained that "two executives from Roche's drug-partnering unit based in China are scouting for opportunities, including licensing experimental medicines." According to Babiss, Roche "may also create spin-offs in the country by helping scientists to set up their own companies with compounds licensed from the" company. In addition, the company "is conducting about six research projects in China and is working with a local partner on an experimental cancer treatment. The collaboration isn't a 'traditional' licensing relationship, Babiss said, without providing details." The company "is also looking to hire 'excellent' scientists in China and is transferring more chemistry-related research to partners there."

        Roche CEO confident company will complete Genentech acquisition. The Wall Street Journal (2/9, Gryta) reports, "Roche Holding AG Chief Executive Severin Schwan reiterated his confidence that Roche will complete its acquisition of the 44 percent of Genentech Inc. that Roche doesn't already own, while expressing frustration at the deal's negotiations." Roche is "very confident that we can get financing in place as soon as we need," Schwan said. "The financing is likely to be 'a mixture of various tools' such as bonds, cash on hand, commercial paper, and bank financing," Schwan explained. "We would approach first the bond markets," Schwan added. In August 2008, "a Genentech independent board rejected Roche's original offer. Last week, after months of failed negotiations, Roche brought the issue to shareholders with a lower tender-offer price." Schwan called "the current tender offer...fair and expressed frustration that Roche and the Genentech independent board couldn't agree to a price, especially because the world economy and financial markets have deteriorated significantly since the July offer."

The Wall Street Journal (2/9, Whalen, Cimilluca) reports, "GlaxoSmithKline PLC, which has moved aggressively into emerging markets, is in talks to buy...Piramal Healthcare Ltd. for roughly $1.5 billion, according to people familiar with the matter." Other drugmakers "have also shown an interest in Piramal, including France's Sanofi-Aventis SA, one person familiar with the matter said. Sanofi-Aventis declined to comment." The Journal explains that "as drug sales slow in mature markets such as the U.S. and Europe, Glaxo and some of its rivals are attempting to expand quickly in emerging markets, where sales in recent years have grown at a higher rate."

        The U.K.'s Times (2/6, Seib), Bloomberg News (2/9, Chatterjee), the AP (2/7), The Times of India (2/8, Mukherjee), and the India Times (2/7) also covered the story.

The Wall Street Journal (2/8, McKay) reported that "the hefty increase in the federal cigarette tax to help fund a children's health-insurance program has buoyed tobacco foes, who say it will breathe new life into efforts to curb smoking." The move, however, "could also complicate efforts around the U.S. to boost state cigarette taxes." Presently, legislators "in at least 16 states -- including Mississippi, Georgia, and Kentucky -- are weighing proposals for significant cigarette-tax increases to fill gaping budget holes or fund programs, calling in some cases for levies more than four times as high as current amounts." But "the sharply increased federal levy could alter their calculus, because the higher cigarette prices are likely to decrease sales, eroding projected tax revenue." Nonetheless, health authorities say "jacking up cigarette prices is one of the best means of curbing smoking, particularly among price-sensitive teens," as "a 10 percent increase in the price of a pack reduces consumption by about four percent."

Modern Healthcare (2/6, Carlson) reported that Sens. Chuck Grassley (R-Iowa) and Jeff Bingaman (D-NM) "are offering two amendments to the economic stimulus bill intended to ratchet up the scrutiny on charity care and not-for-profit hospitals." One proposal would require the International Revenue Service, the Centers for Medicare and Medicaid Services (CMS), and the Medicare Payment Advisory Commission to "cooperatively develop a standard definition of uncompensated care and charity care." Meanwhile, the second amendment would allow "for the IRS to conduct an in-depth study of the for-profit hospital industry...to determine how much charity care is provided by investor-owned hospitals." Sen. Grassley is also "expected to introduce 'bright line' legislation this session that would define a specific amount of community benefit that hospitals must provide to justify tax exempt status." The Wall Street Journal (2/6, Goldstein) Health Blog also covered the story.

The New York Times (2/7, B3, Abelson) reported that "at the prodding of one of" Arizona's "big employers, IBM," the "giant insurer UnitedHealth Group is testing a new model of healthcare." Testing "the 'medical home' model of healthcare," insurer "UnitedHealth will try giving doctors more authority and money than usual in return for closely monitoring their patients' progress, even when patients go to specialists or require hospitalization." Specifically, "the insurer will also move away from paying doctors solely on the basis of how many services they provide, and will start rewarding them more for the overall quality of care patients receive." Experts theorize that "by providing a home base for patients and coordinating their treatment, doctors can improve care, prevent unnecessary visits to the emergency room, reduce hospitalizations, and lower overall medical spending." The "experiment," which "will initially involve about 7,000 patients who are the patients of 26 doctors at the seven medical groups," is "set to run through 2011."

The Wall Street Journal (2/7, Pasztor) reported, "After years of resisting regulations to mandate more safety equipment and enhanced pilot training for all emergency medical helicopter operations in the U.S., federal regulators said they are pushing ahead with various new rules in this area." FAA officials said the agency "is actively working on proposing regulations covering use of ground collision-avoidance warning systems; night-vision goggles; beefed-up training for pilots as well as flight dispatchers; and across-the-board efforts to improve risk assessment when it comes to flights in poor weather or low visibility."

        According to MedPage Today (2/6, Walker), "last year's rash of emergency medical helicopter crashes were mostly the result of obsolete technology and bad guesses about weather, witnesses told the National Transportation Safety Board at hearings this week." At the hearing, witnesses said that "most accidents were a result of pilots not taking proper safety precautions, inadvertently flying into severe weather, and becoming disoriented at night." The NTSB "will consider the testimony and make safety improvement recommendations in the upcoming weeks to the FAA, which may then develop new regulations on medical helicopters."

Following an article by MedPage Today, Tara Parker-Pope wrote in the New York Times (2/6) Well blog that "new research," published in the Lancet, "shows scanning to find the source of back pain may do more harm than good." For their study, "researchers from Oregon Health and Science University in Portland reviewed six clinical trials comprised of nearly 2,000 patients with lower back pain." The team "found that back pain patients who underwent scans didn't get better any faster or have less pain, depression or anxiety than patients who weren't scanned." Furthermore, "the data suggested that patients who get scanned for back pain may end up with more pain than those who are left alone."

        BBC News (2/7) added that the investigators "looked at pain, function, quality of life, mental health, overall patient-reported improvement and patient satisfaction in the care they received for up to a year after their initial treatment," among the study participants, who were "randomized to receive either immediate scans or standard clinical care." Specifically, the researchers "did not find significant differences between immediate imaging with X-ray or MRI scans and usual clinical care either in the short-term -- up to three months later, or the long-term -- six to 12 months."

        According to HealthDay (2/6, Preidt), "the results apply most strongly to patients with acute or sub-acute low back pain assessed in a family doctor's office." The study's authors concluded that the findings mean physicians "should not conduct routine MRI, CT or radiography unless they see signs of a serious underlying condition." Canada's CBC News (2/7) and Medscape (2/6, Jeffrey) also covered the story.

American Medical News (2/9, Sorrel) reports, "A federal appeals court for the first time spelled out what constitutes an investigation under the Health Care Quality Improvement Act." Under the federal statute, hospitals are required "to report physicians to the National Practitioner Data Bank if they have been reprimanded for quality or conduct issues, or if they surrender privileges while under investigation." But, a decision by the 1st U.S. Circuit Court of Appeals "clarified that an investigation remains ongoing until the hospital's decision-making process runs its course, and the medical executive committee either takes final corrective action or formally closes the probe." The case centered on an investigation into a nurse's allegations that a physician threatened her. When the physician voluntarily resigned, "the hospital, believing the physician resigned while under investigation, reported him to the data bank." The physician then "challenged the notification to the data bank," arguing that the investigation had ended. The 1st Circuit, however, affirmed the administrative appeal decision that the "the doctor resigned before the query was formally resolved."

Life Sciences Law

The AP (2/9) reports, "Lawmakers in 11 states are considering bills that would offer or require ultrasounds before a woman gets an abortion." Of the proposed laws, Nebraska, Indiana, and Texas face "the most stringent," requiring physicians to "show the ultrasound image of the fetus to the woman, despite legal challenges to a similar measure in Oklahoma." The proposal in Indiana also "requires the mother to listen to the fetal heartbeat." In Oklahoma, physicians are required to present the ultrasound "to the woman, even if she refuses to look at it," and to "describe the picture." The law has been "put...on hold after the Center for Reproductive Rights filed a lawsuit saying it intrudes on privacy, endangers health, and assaults dignity." Meanwhile, "sixteen states already have laws related to abortion ultrasounds, some requiring they be performed and others requiring a woman be told where she can get a free ultrasound." In South Carolina, lawmakers reached a "compromise," approving "a law requiring that women be given the option of viewing an ultrasound at least one hour before getting an abortion."

Bloomberg News (2/7, Decker) reported, "Eli Lilly & Co. today asked a U.S. appeals court to overturn a $65.2 million verdict won by Ariad Pharmaceuticals Inc. over royalties on the osteoporosis drug Evista [raloxifene] and the sepsis medicine Xigris [drotrecogin alfa]." In May 2006, "a federal jury in Boston determined...that the drugs rely on a technique developed by researchers at Harvard University, the Massachusetts Institute of Technology, and the Whitehead Institute," and is "covered by a patent licensed to Ariad by the schools." In doing so, "the jury awarded $65.2 million and said Lilly should pay royalties of 2.3 percent of sales of the two drugs." But, Lilly contends that Ariad claimed "a patent on something that occurs in nature, which isn't allowed by U.S. patent law." Meanwhile, Ariad attorney Stephen Rabinowitz stated that "the patent covers a 'previously unknown way' of treating diseases by regulating a protein called NF-KappaB." The technique reduces the protein, altering "the way cells respond to stimulus, such as infection." Lilly also argues that "the inventors failed to adequately describe their invention or explain how others could replicate their work."

The Minneapolis Star Tribune (2/7, Moore) reported that "a U.S. Supreme Court ruling last year -- heralded by the Bush administration and the med-tech industry alike -- would have a crushing effect on hundreds of" medical device lawsuits as "the high court restricted legal options for patients who claimed they've been injured by a defective device." The court wrote, "If the Food and Drug Administration (FDA) approved the device following a rigorous review...then a suit by an aggrieved patient could not be filed under state laws." Now, "consumer and legal advocates claim that the prospect of costly litigation keeps device companies in check and pressures them to make the safest products possible." According to the Tribune, "the rulings have left hundreds of patients in a legal purgatory -- unable in many cases to get their day in court."

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