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  • Reimbursement

    • Congress Poised to Revamp TRICARE Retail Pharmacy Rebate ProgramDecember 13th, 2007

      Department of Defense (“DoD”) authorization bills currently pending in Congress (both H.R. 1585 and S. 1547) contain authority for a new, mandatory TRICARE retail pharmacy rebate program.  TRICARE is the military’s health care program serving active duty service members, retirees, their families, survivors and certain …

    • Pharmacy Associations Challenge Final CMS AMP Rule; Legislative Fixes Pending in CongressNovember 20th, 2007

      The Deficit Reduction Act of 2005 changed the basis for the federal government’s calculation of how much it reimburses states for their Medicaid generic prescription drug purchases.  Instead of using the “average wholesale price,” or AWP, which is a benchmark price, the federal reimbursement is …

    • When Safe and Effective Means Neither Safe Nor EffectiveOctober 23rd, 2007

      We previously reported on a May 2007 Proposed Decision Memorandum issued by the Centers for Medicare and Medicaid Services (“CMS”) that would restrict the use of Erythropoiesis Stimulating Agents (“ESAs”) in cancer-related anemia and similar conditions.  The proposed memorandum was finalized in a July 30, …

    • CMS Final Rule on the Medicaid Drug Rebate ProgramAugust 9th, 2007

      We previously reported on some of the highlights of the most notable provisions of the final rule issued by the Centers for Medicare & Medicaid Services (“CMS”) on the Medicaid Drug Rebate Program.  Today, Hyman, Phelps & McNamara, P.C. issued a detailed memorandum summarizing the …

    • CMS Takes Another Stab at Updating its Medicare Clinical Trial PolicyJuly 24th, 2007

      After a highly anticipated revision of Medicare’s Clinical Trial Policy (“CTP”) that was issued in a July 9, 2007 Decision Memorandum (“Proposed Decision”) left many scratching their heads, the Centers for Medicare & Medicaid Services (“CMS”) issued a Proposed Decision Memorandum for Second Reconsideration of …

    • Highlights of the Final CMS Medicaid Rebate RuleJuly 16th, 2007

      On July 6, 2007, the Centers for Medicare & Medicaid Services (“CMS”) posted on its website a pre-publication copy of a final rule with a comment period to implement the Medicaid Rebate Program.  The regulation, which finalizes a proposal that was published in the Federal …

    • CMS Restricts Coverage Of Anti-Anemia Drugs For Cancer: Are Restrictions For ESRD Use Up Next?May 25th, 2007

      The Centers for Medicare & Medicaid Services (“CMS”) continues to evaluate and modify, where necessary, Medicare coverage of anti-anemia drugs.  On May 14, 2007, after reviewing clinical evidence in peer-reviewed literature and considering concerns raised by a recent FDA advisory panel, CMS issued a Proposed …

    • 340B Program Listens to Reason – No Need for Two AMP CalculationsMay 17th, 2007

      As pharmaceutical manufacturers all know by now, the Deficit Reduction Act changed the definition of the average manufacturer price reported to the Centers for Medicare & Medicaid Services for purposes of the Medicaid Rebate Program, requiring that customary prompt pay discounts to wholesalers are no …

    • CMS Proposes HCPCS Coding Changes for IVIGMay 15th, 2007

      The Centers for Medicare & Medicaid Services (“CMS”) proposed brand-specific Healthcare Common Procedural Coding System (“HCPCS”) code changes for intravenous immune globulin (“IVIG”) that may lead to enhanced reimbursement for the biologic.  The HCPCS coding changes are effective July 1, 2007, and were announced in …

    • CMS Issues Draft Clinical Research PolicyApril 12th, 2007

      On April 10, 2007, CMS issued a draft of its revised Clinical Trial Policy, renamed Clinical Research Policy.  The draft policy was issued after CMS’s consideration of public comments on the agency’s July 10, 2006 coverage tracking sheet announcing the reconsideration of the September 19, …

    • Deficit Reduction Act of 2005 False Claims Act Education Requirements Are Not Applicable to Pharmaceutical ManufacturersMarch 28th, 2007

      The Deficit Reduction Act of 2005 (“DRA”) provided that any entity that receives or makes annual payments under a Medicaid State plan of at least $5,000,000 must, as a condition of receiving such payments, establish written policies for employees, contractors, and agents that provide detailed …

    • Senate Appropriations Committee Votes to Increase Rebates for Brand Name Products under the Medicaid Drug Rebate ProgramMarch 26th, 2007

      On March 22, 2007, the Senate Appropriations Committee approved S. 965, a bill making emergency appropriations primarily for the wars in Iraq and Afghanistan.  During the Committee’s consideration of the bill, it adopted an amendment offered by Senator Dick Durbin (D-IL) regarding the Medicaid Program.  …

    • Medicare Revokes Payment for ARANESPMarch 19th, 2007

      Reacting to a February 2007 FDA safety alert on the off-label use of erythropoietic stimulating agents (ESAs), Noridian Administrative Services (Noridian), a Medicare Administrative Contractor for 13 states in the west and midwest, announced that, effective March 5, 2007, Medicare will deny payment for the …