Drug Topics - January 14, 2008 - (Page 6) 6 DRUG TOPICS JANUARY 14, 2008 www.drugtopics.com Latebreakers Judge rules against AMP temporary injunction has stopped the Centers for Medicare & Medicaid Services from implementing the average manufacturer price (AMP) rule for Medicaid generic drug reimbursement. In a December hearing, Judge Royce Lamberth granted the injunction after concluding that the case filed by NCPA and NACDS was likely to succeed and that “implementation of this scheme would, in fact, put [pharmacies] out of business.” In the suit, NACDS and NCPA charged that CMS had exceeded its mandate from the Deficit Reduction Act and that CMS had contradicted numerous aspects of the Social Security Act, including its definition of AMP. The order blocks CMS from implementing the new rule as well as posting AMP data on its Web site. The case will go to trial beginning in January. Officials at NCPA and NACDS are still hoping for a legislative fix for the AMP rule. A launching an educational teleconference series to educate DMEPOS suppliers on the accreditation process. The first will take place January 22, 1 pm EST. The other conferences will be held in April, July, and September. Wis., the capsule will be reopened at an ASHP meeting in 2057. New beta-blocker Bystolic gets FDA nod Beta-blocker nebivolol (Bystolic), from both Forest Laboratories and Mylan, Inc., has been approved by the FDA for the treatment of hypertension. The new molecular entity is orally available and can be used alone or in combination with other antihypertensive agents. According to the manufacturer, nebivolol works by decreasing heart rate and contractility and suppressing renin activity. The drug is a selective beta-1 blocker and is available in 2.5-mg, 5-mg, and 10-mg tablets. Drug Topics launches time capsule for future pharmacists It doesn’t contain Oxycontin or Viagra, but Drug Topics’ time capsule, which was sealed at the ASHP midyear meeting in Las Vegas last month, harbors other goodies that capture the ethos of pharmacy circa 2007. Set up to commemorate Drug Topics’ 150th anniversary last year, the time capsule is designed to give pharmacists of the future a snapshot of what pharmacy was like in 2007. Among the collectables in the eight-cubic-foot chest are Wolters Kluwer Health’s 2007 edition of Facts & Comparisons, a T shirt from National Council for Prescription Drug Programs proclaiming “I survived NPI,” and other timely knick-knacks. To be stored for the next 50 years at the American Institute of the History of Pharmacy (AIHP) in Madison, CMS sets accreditation deadlines for Part B DMEPOS suppliers The Centers for Medicare & Medicaid Services recently announced accreditation deadlines for all Part B durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) providers. In order for any Part B supplier to obtain or retain their Part B enrollment National Supplier Clearinghouse (NSC) number, he or she must submit his or her approved accreditation with one of the 10 deemed accreditation organizations by or before Sept. 30, 2009. If suppliers are not accredited by that date, the NSC will revoke their billing privileges. Suppliers who are currently in the program need to obtain a National Provider Identifier (NPI) and start using that number in the submission of any claims effective March 1, 2008. All claims will have to have an NPI on the claim form and that can be an NPI only or an NPI in combination with an existing legacy identifier. CMS also announced it is First drug approved for treatment of phenylketonuria The FDA and Biomarin Pharmaceutical Inc. have announced the approval of sapropterin (Kuvan), the first new molecular entity given a regulatory nod for the treatment of phenylketonuria (PKU), a condition that affects about 50,000 patients worldwide. Sapropterin is the synthetic form of 6R-BH4 (tetrahydrobiopterin), an enzyme cofactor that works with phenylalanine hydroxylase to metabolize phenylalanine. Prolonged exposure to high levels of phenylalanine can result in severe neurological damage. The drug has received seven years of market exclusivity as an orphan drug from the FDA. According to the manufacturer, not all patients with PKU will respond to sapropterin, but a therapeutic trial with the drug can determine who will benefit. Sapropterin should be used in conjunction with a phenylalanine-restricted diet. DT Locking the capsule are Drug Topics’ publisher Joe Laborsky, R.Ph., in the foreground and pharmacisthistorian Michael Harris in the back. Greg Higby of AIHP looks on. Photo at bottom: Michael Barbella http://www.drugtopics.com
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