Health Law

CQ (2/11, Carey) reports, "As 200 members of the American Association for Homecare prepare for a lobbying blitz Wednesday on Capitol Hill, the trade group for durable medical equipment providers on Tuesday reiterated a set of principles it says will help prevent fraud and abuse in the Medicare program." Some of these principles "include mandating site inspections for all providers of durable medical equipment (DME) for home use, which includes walkers, hospital beds, and oxygen. Site inspections also should be required for all home medical equipment provider renewals, and new homecare providers should be subject to a 'comprehensive and effective applications process' before obtaining a Medicare supplier number." According to AA Homecare president Tyler Wilson, "the anti-fraud plan is the group's attempt to help reduce Medicare fraud, which costs the $430 billion program as much $60 billion a year. DME accounts for $10 billion of Medicare spending, and fraud in that sector accounts for less than $1 billion of that amount."

The Wall Street Journal (2/11, Berton) reports that "Sanofi-Aventis SA on Wednesday unveiled plans to reshuffle its operations, as the French drugmaker reported fourth-quarter earnings ahead of guidance, helped by the stronger dollar." Sanofi "posted a 14 percent rise in net profit in the three months to Dec. 31, to €1.63 billion ($2.1 billion) from €1.43 billion a year earlier, as net sales rose 2.6 percent to €7.09 billion from €6.91 billion, helped by the strengthening of the dollar against the euro." According to Chief Executive Chris Viehbacher, "the company will resort to acquisitions and broaden the scope for alliances as its research and development projects won't be enough to compensate for the sales the company stands to lose after Plavix [clopidogrel bisulfate] and Lovenox [enoxaparin] lose their patents." The company "is reviewing its portfolio of experimental drugs and expects to report on the findings at the company's first-quarter results, Mr. Viehbacher said, adding that the drugmaker could exit whole therapeutic areas based on the results of the review."

        Bloomberg News (2/11, Kelley, Torsoli) adds that Viehbacher "created three new positions at the company: chief strategy officer, chief medical officer and scientific adviser." Viehbacher "said Laurence Debroux, who became chief financial officer in December, will take the strategy job." The AP (2/11) also covers the story.

        Sanofi-Aventis plans to expand further into consumer health, generics and biological medicines, CEO says. The Financial Times (2/11, Jack) reports, "The new chief executive of Sanofi-Aventis plans to expand further into consumer health, generics and biological medicines in his efforts to transform the French pharmaceuticals group." Chris Viehbacher told the Times "that he would shift Sanofi-Aventis from 'an EU/US-centric pharma company to a global healthcare company' through acquisitions and internal restructuring." Viehbacher said Sanofi "had 'missed the boat' on diversifying into biological medicines, and would involve governments and insurers that pay for medical care more in future development to ensure 'you bring medicines of value to the marketplace.'"

Bloomberg News (2/10, Frye) reported that Genworth Financial Inc. "plans to direct resources to life insurance and long-term care after losses on retirement products and mortgage guarantees." Chief Executive Officer Michael Fraizer stated that the company "is scaling back unprofitable businesses...after soured investments and claims on bad mortgages depleted capital." But, he noted that Genworth has "seen growth" in its long-term care insurance, explaining that such coverage "is poised to increase because as 'boomers are aging, they're facing that reality of" taking care of seniors. Although Genworth "reported a $321 million loss for the three months ended Dec. 31," its "fourth-quarter earnings from long-term care coverage climbed about 36 percent to $49 million."

CQ (2/11, Reichard) reports, "Senate Budget Committee Chairman Kent Conrad [D-ND] warned fellow lawmakers Tuesday against health overhaul plans that would add 'hundreds of billions of dollars' to the nation's healthcare tab, saying they face 'a heavy burden' making the argument for such changes." Conrad "issued that stern warning...at the start and end of a hearing that dealt largely with what to do about runaway health spending. Because respected economists put the annual cost of such overhaul plans at between $100 billion and $200 billion, Conrad appeared to be saying that universal coverage proposals won't be enacted." Nonetheless, he "stopped short of that conclusion when asked after the hearing if universal coverage is possible, given the nation's huge fiscal challenges."

        CongressDaily (2/11) adds, "The Senate Budget Committee took a somber look at healthcare reform, and warned that simply increasing federal spending won't help achieve President Obama's pledge to make healthcare more affordable, or more available." According to Sen. Ron Wyden (D-OR), "'We are spending enough'...but 'we aren't spending it in the right places.'" Meanwhile, "CBO Director Douglas Elmendorf told the panel that any effort to expand healthcare in America would require the federal government to provide three fundamental elements: a way to pool risk, subsidies to make insurance more affordable, and an enforceable mandate that all Americans should have insurance."

The AP (2/10) reported, "Gov. Jim Doyle has asked the federal government to extend Wisconsin's one-of-a-kind SeniorCare prescription drug program for another three years." Two years ago, "Congress extended the program...so it will run through Dec. 31. It serves 86,000 senior citizens in Wisconsin." Notably, advocates of SeniorCare "say it is easier to use, and more cost-effective that Medicare Part D. It costs $30 to enroll in the program, the deductible is income-based, and copayments are just $5 for generic drugs, and $15 for brand drugs."

The Hartford Courant (2/11, Levick) reports that "Connecticut women under 40 would pay less for individual health insurance policies if legislators approve a ban on using gender to figure rates, a practice condemned by consumer advocates as discrimination." An industry lobbyist, however, said that "the proposal, considered Tuesday by the state legislature's insurance and real estate committee, would result in higher premiums for other policyholders." Last year, a report "by the National Women's Law Center in Washington, D.C., found that insurers charged 40-year-old women 4 percent to 48 percent more than 40-year-old men for the same plans." According to Attorney General Richard Blumenthal, "basing rates on gender 'should be as illegal as it would be on the basis of race or religion,' and it's 'unconscionable and unacceptable.'" But, Keith Stover, a lobbyist for the Connecticut Association of Health Plans, argues, "If gender is banned from rate making, premiums will rise for some people while falling for others because the ban does not change the overall level of claims."

The Christian Science Monitor (2/11, Marks) reports, "The economic stimulus bill before Congress is certain to include billions of dollars to bring electronic record keeping to the healthcare industry." But, "lawmakers in the House and Senate are...waging a battle over how to ensure that a patient's very private medical history is protected." In particular, the disputed health IT provisions center on "what kind of rules" would ensure "privacy while striving for efficiency." According to privacy advocates, "individuals should be able to control who can see their medical record and when." Such protections, however, "could conflict with the effort to improve overall outcomes." Currently, "the House version of the stimulus bill...has stronger privacy protections than the Senate version," requiring "medical and insurance professionals to alert consumers of any unauthorized disclosure of their medical information." The Senate version, on the other hand, "would leave disclosure to the discretion of the Secretary of Health and Human Services."

The AP (2/11) reports that Texas' "Parkland Memorial Hospital, where a man died after waiting 19 hours for emergency [department] treatment in September, has made several changes to improve care and reduce long waits," according to the hospital's top executive, Dr. Ron Anderson. Some of "the changes include eliminating computer kiosks that had been used since summer 2007 for patients to check themselves in." Rather than "using the kiosks' touchscreens to enter their personal information and then indicate their ailment, patients are now greeted by a paramedic who does a screening to identify urgent needs." According to Dr. Anderson, "the number of patients leaving without seeing a doctor had been as high as 24 percent at times, but that it dropped to 15 percent when the new process started in December."

        The Dallas Morning News (2/11, Jacobsen) reports that "some of the changes were the result of an Oct. 21 evaluation of Parkland's emergency operations by the Joint Commission." That "evaluation followed the death of...a 58-year-old Dallas man who checked into the [emergency department] Sept. 19 and died of cardiac arrest after waiting 19 hours for treatment." The Joint Commission "cited 11 deficiencies in Parkland's [emergency department], including inadequate check-in procedures, failure to offer proper pain medication to waiting patients, and ineffective leadership in some areas."

The Los Angeles Times (2/11, Girion) reports, "Anthem Blue Cross, the state's largest for-profit health insurer, has agreed to pay a $1-million fine and offer new coverage -- no questions asked -- to 2,330 people it dropped after they submitted bills for expensive medical care." The insurer "also will offer to reimburse those people for medical expenses that they paid out of pocket after they were dropped." Anthem "estimated that those reimbursements could reach $14 million." In the settlement, "the state agreed to drop its prosecution of its accusation that the company broke state laws in the way it rescinded members in preferred provider organization (PPO) policies between 2004 and 2008." The Times notes that "the Anthem deal is the latest in a two-year effort by regulators to crack down on health insurers for dropping sick members on dubious grounds."

Bloomberg News (2/11, Pettypiece) reports that "the Epilepsy Foundation of America and other patient-advocacy groups are pressing lawmakers in at least 33 states to stop pharmacies from substituting generic drugs for the originals before patients and their doctors are alerted to the changes" after they received "more than 1,000" reports of patients suffering epileptic seizures after having their medicine switched to a generic version. Generic drugs can cost up to "70 percent less than the originals," causing some states, insurers, and employers to "insist that pharmacists fill patients' prescriptions with a generic to save money." And "while routine switching of drugs may make sense for many patients, a growing number with epilepsy, depression, heart disease, and transplanted organs have suffered side effects after getting generic substitute," according to some medical associations. "Generic-drug makers and health insurers say anecdotal evidence falls short of definitive proof that differences between generic medicines and the originals cause side effects," but four states have already "passed measures that stop pharmacies from automatically switching customers on prescription medicines to generics."

The Los Angeles Times (2/11, Therolf) reports, "Los Angeles County officials said Tuesday that they do not know how many of the 2,000 temporary workers serving patients at county hospitals and clinics each month are working without a criminal background check." This "acknowledgment came as the county suspended the contract for one of its largest providers of temporary healthcare professionals, a move made because the agency placed a convicted rapist at a large East Los Angeles health clinic." According to John Schunhoff, interim director of the Department of Health Services, "a wide review of the criminal histories of his department's 20,000 staffers, requested late last year by Supervisor Mike Antonovich, is not possible." Schunhoff said, "We just don't have the appropriate documentation to conduct a proper look backward," but added "that he has worked to ensure that county policy is applied appropriately in moving forward."

ABC World News (2/10, story 12, 2:15, Gibson) reported, "There are new questions about the California woman who gave birth to octuplets last month. The American Society of Reproductive Medicine [ASRM] says it's investigating whether Nadya Suleman's doctor violated guidelines for the number of embryos which can be implanted at one time."

        In the Los Angeles Times (2/10) L.A. Now blog, Shelby Grad wrote that the group's move follows a similar announcement by the California Medical Board. R. Dale McClure, president of the ASRM, stated that the group is "pleased that the California Medical Board has announced they will be investigating" the issue, and that the ASRM is "prepared to assist them."

        The woman, Nadya Suleman, said that she "received in-vitro fertilization for all 14 of her children at the same Beverly Hills fertility clinic" using "six embryos in each of her six pregnancies," the AP (2/11) adds. But, "no more than three embryos are considered the norm for a woman her age." McClure stated that "it seems that the guidelines may not have been followed in Ms. Suleman's case." Her physician, Dr. Michael Kamrava, of West Coast IVF Clinic in Beverly Hills, "was identified Monday" during "an NBC interview with Suleman."

        MedPage Today (2/10, Gever) noted that, according to data from the Centers for Disease Control and Prevention, "West Coast IVF Clinic reported pregnancy and live-birth rates well below the national average" in 2006. In fact, Dr. Kamrava's clinic "performed a total of 52 egg extractions from women seeking to become pregnant in 2006." And, "among 20 in women younger than 35, only four (20 percent) resulted in pregnancy." Meanwhile, "nationally, the average rate of pregnancies per cycle for women younger than 35 was 44.6 that year." According to a spokeswoman for the California Medical Board, the agency will "determine whether the physician...was out of order in implanting" all six embryos in Suleman.

Life Sciences Law

Bloomberg News (2/11, Weidlich) reports that "Schering-Plough Corp. and its joint venture with Merck & Co., marketers of cholesterol pill Vytorin [ezetimibe and simvastatin], asked a judge overseeing a suit against them to toss out allegations from what they call a 'repulsive, offensive and obscene' website." Schering-Plough and the joint venture were sued by investors "for securities fraud, saying they withheld test results that showed Vytorin didn't unclog arteries better than an older and cheaper medicine. The complaint includes anonymous postings from CafePharma, a site for drug salespeople, that the investors said show Schering-Plough's intent to deceive." The defendants argue that "the site's anonymous posts are unreliable and often obscene." The investors, however, "said that none of the posts they quoted in their complaint contain obscenities or offensive material."

On the front page of its Business Day section, the New York Times (2/11, B1, Singer) reports, "As part of an unusual crackdown on deceptive consumer drug advertising, the Food and Drug Administration and the attorneys general of 27 states have required Bayer to run these new ads to correct previous Yaz [drospirenone and ethinyl estradiol] marketing." Regulators claim "the ads overstated the drug's ability to improve women's moods and clear up acne, while playing down its potential health risks. Under a settlement with the states, Bayer agreed last Friday to spend at least $20 million on the campaign and for the next six years to submit all Yaz ads for federal screening before they appear." The corrective television ads, "which began appearing two weeks ago, are scheduled to run until July 26. New print ads, in national magazines like Lucky and Elle, give detailed information about Yaz, but do not indicate they are meant to correct earlier television ads."

Bloomberg News (2/10, Kresge) reported, "Pfizer Inc., Eli Lilly & Co. and Bayer AG, rivals in the male impotence-drug market, fixed prices in Switzerland and should be punished, a panel of the Swiss Competition Commission said." The pharmaceutical companies "have 20 days to respond before the commission decides whether to follow the panel's recommendation to penalize the companies or prohibit them from suggesting prices for the pills." According to the panel, the companies "made 'inadmissible vertical competition agreements' by maintaining a recommended public selling price for the drugs." A spokesperson for Bayer, maker of Levitra (vardenafil hcl), and a spokesperson for Pfizer, maker of Viagra (sildenafil citrate), "declined to comment on the investigation, saying the companies hadn't had time to analyze the Swiss panel's claims." A spokesperson for Lilly, maker of Cialis (tadalafil), said that "we are confident that we respected Swiss law," but "declined to comment on the specifics of the investigation."

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