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CMS Proposes Payment Changes For Home Health Services To Protect Beneficiaries And Medicare
The Centers for Medicare & Medicaid Services (CMS) announced a proposed 2.2 percent home health market basket update to the home health prospective payment system (HH PPS) rates for calendar year (CY) 2010. Also, as part of ongoing efforts to address potential fraud and abuse with regards to outlier payments under the HH PPS, CMS is proposing modifications to its outlier policy.
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NICE Upholds GlaxoSmithKline Appeal For Advanced Breast Cancer Treatment, Tyverb(R)(lapatinib)
The National Institute for Health and Clinical Excellence (NICE) announced that, following GlaxoSmithKline"s (GSK) appeal, it will reconsider the submission for Tyverb (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive).1 GSK is pleased that NICE"s appeal panel agreed that the draft negative guidance should be reviewed, providing fresh hope for up to 2,000 women in the UK who could benefit from this effective treatment on the NHS.
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Watson Pharmaceuticals Receives FDA Approval For Generic PLAN B(R)
Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for levonorgestrel tablets, 0.75 mg, for women seventeen years and younger. Levonorgestrel is the generic equivalent to Duramed Pharmaceuticals" PLAN B(R), which is indicated for the prevention of pregnancy following unprotected intercourse or contraceptive failure. This product is approved for prescription use only. The Company intends to market the product under the trade name Next Choice(TM) and plans to launch the product shortly. For the 12-months ending March 2009, PLAN B(R) had total U.S. sales of approximately $123 million, of which approximately ten percent are attributable to prescription sales, according to IMS sales data. PLAN B(R) over-the-counter (O.T.C.) new product exclusivity expires on August 24, 2009.
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Lawsuits Allege Some Medical Device Companies Gave Kickbacks To Surgeons

Whistleblowers allege in lawsuits unsealed Wednesday that some medical device companies gave kickbacks to heart surgeons to get the doctors to use their products to treat a heart condition, The Wall Street Journal reports. "The lawsuits, filed in federal district court in Houston, name at least four companies whose products are among those used in surgery to treat the heart condition (called atrial filrillation). They are AtriCure Inc., Medtronic Inc., St. Jude Medical Inc. and Boston Scientific Corp." "The suits, originally filed in 2007 but recently unsealed by a Texas federal judge, allege that a "fraudulent marketing and inducement campaign" involving kickbacks to doctors and hospitals resulted in excessive charges to the Medicare insurance program." "The case against Boston Scientific was filed by a former saleswoman who says she was fired after complaining about illegal practices at the company." One of the plaintiffs say the companies marketed the tools as surgical ablation equipment even though it wasn"t approved by the Food and Drug Administration (Burton and Armstrong, 7/16). "These off-label uses were more expensive than those sanctioned by the FDA, and resulted in the government"s Medicare program being overbilled, according to the documents," The Associated Press/Houston Chronicle reports: "The whistleblower also alleges that the companies "offered the surgeons kickbacks in the form of free advertising, press, and referral services to bring in more patients and business"" (Perrone, 7/15). This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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