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Added line is this color Deleted line is this color -<!--StartFragment --> <br> +<!--StartFragment --> <br> <h3 class="header" id="titleh3"><strong><a href= "http://www.cms.hhs.gov/CoverageGenInfo/02_compendia.asp#TopOfPage">Compendia 1861(t)(2) – Anti-cancer</a></strong></h3> <ul> <li><small><a href= "http://www.cms.hhs.gov/CoverageGenInfo/02_compendia.asp#TopOfPage">Compendia Request Review Process [PDF, 19KB]</a></small></li> <li><small><a href= "http://www.cms.hhs.gov/CoverageGenInfo/Downloads/compendiapreamble.pdf">Compendia Regulation - Pages 467-482 of the CY 2008 Physician Fee Schedule [PDF, 62KB]</a></small></li> <li><small><a href= "http://www.cms.hhs.gov/CoverageGenInfo/Downloads/compendiareg.pdf">Compendia Regulation Text – § 414.930 Page 66404 of the FR [PDF, 423KB]</a><span class= "pdf" title="pdf icon"> </span></small></li> </ul> <br> -<h2>Compendia Sources</h2> +<h2>Compendia History</h2> <p><small><span style="FONT-WEIGHT: bold">Compendia recognized by CMS</span> [per SSA 1861(t)(2)(B)(ii)(I)]:</small></p> <ol> <li><small>American Medical Association Drug Evaluations (<font color= "#3333FF"><strong>AMA-DE</strong></font>)</small></li> <li><small>United States Pharmacopoeia-Drug Information (<font color= "#6600CC"><strong>USP-DI</strong></font>) or its successor publication [amended in Section 6001 (f)(1) of the Deficit Reduction Act of 2005]</small></li> <li><small>American Hospital Formulary Service-Drug Information (<strong><font color="#333399">AFHS-DI</font></strong>)</small></li> </ol> -<p><small>However:</small></p> +<p style="FONT-WEIGHT: bold"><small>However:</small></p> <ul> <li><small><strong><font color="#3333FF">AMA-DE</font></strong> no longer published.</small></li> <li style="LIST-STYLE-TYPE: none"> <ul> <li><small>2/6/08 -- <a href= "http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?from=whatsnew&id=13">CMS internally generated a request for the deletion of the AMA-DE from the list of compendia for this use</a>.</small></li> </ul> </li> <li><small><strong><font color="#6600CC">USP-DI</font></strong> no longer published, and Thomson Micromedex has designated <strong><em>Drug Points</em></strong> as the successor to <strong><em>USP-DI</em></strong>. However, in the <a href= "http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-3274.pdf">2008 MPFS Proposed Rule</a>, CMS questioned whether <strong><em>Drug Points</em></strong> is a <u>successor</u> or <u>substitute</u> to <strong><em>USP-DI</em></strong>, which would affect recognition as a compendia. [72 Fed Reg 38177]</small></li> <li><small>Requests for publications to be added as compendia</small></li> <li style="list-style: none"> <ul> -<li><small><span style="FONT-WEIGHT: bold">NCCN Drugs and Bilogics -Compendium</span><br></small></li> -</ul> -<div style="margin-left: 2em"> +<li><small><span style="FONT-WEIGHT: bold">NCCN Drugs and Biologics +Compendium</span></small></li> +<li style="list-style: none"> <ul> <li><small>NCCN <a href= "http://www.cms.hhs.gov/CoverageGenInfo/downloads/covdoc14.pdf">request</a> to add <strong><em>NCCN Drugs and Biologics Compendium</em></strong> as mandated reference for Medicare coverage decisions (i.e., as one of compendia recognized by Medicare) on February 8, 2008</small></li> +<li><small>CMS <a href= +"http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=14">added</a><span style= +"FONT-WEIGHT: bold"> NCCN Drugs and Biologics Compendium</span> to compendia +list on June 5, 2008</small></li> </ul> +</li> +<li><small>Elsevier Gold Standard’s <span style="FONT-STYLE: italic">Clinical +Pharmacology</span> </small></li> +<li style="list-style: none"> <ul> -<li><small>CMS <a href= -"http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=14">added</a> -<span style="FONT-WEIGHT: bold"> NCCN Drugs and Biologics Compendium</span> to -compendia list on June 5, 2008</small></li> +<li><small>Elsevier Gold Standard's <a href= +"http://www.cms.hhs.gov/CoverageGenInfo/downloads/covdoc17.pdf">request</a> on +February 11, 2008 to add <span style="FONT-STYLE: italic">Clinical +Pharmacology</span> to compendia list</small></li> +<li><small>CMS <a href= +"http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=3186&intNumPerPage=10&checkDate=&checkKey=&srchType=1&numDays=3500&srchOpt=0&srchData=&keywordType=All&chkNewsType=1%2C+2%2C+3%2C+4%2C+5&intPage=&showAll=&pYear=&year=&desc=&cboOrder=date"> +added</a> <span style="FONT-WEIGHT: bold">Clinical Pharmacology</span> to +compendia list on July 2, 2008</small></li> +<li style="list-style: none"> +<ul> +<li><small>CMS <a href= +"http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=17">Tracking Sheet and +Decision Memo</a><br></small></li> </ul> -</div> </li> </ul> -<small><strong><big><big><big><br> -Compendia Policy Descriptions</big></big></big><br> +</li> +</ul> +</li> +</ul> +<p style="FONT-WEIGHT: bold"><big>CURRENT CMS-RECOGNIZED COMPENDIA <small>(as +of 2 July 2008)</small></big></p> +<ul> +<li><small>NCCN Drugs & Biologics Compendium™</small></li> +<li><small>Thomson Micromedex DrugDex®</small></li> +<li><small>Elsevier Gold Standard’s <span style="FONT-STYLE: italic">Clinical +Pharmacology</span> </small></li> +</ul> +<p> </p> +<small><strong><big><big><big>Compendia Policy +Descriptions</big></big></big><br> <br> Technology Assessment: <a href= "http://www.cms.hhs.gov/determinationprocess/downloads/id46TA.pdf">Compendia for Coverage of Off-Label Uses of Drugs and Biologics in an Anticancer Chemotherapeutic Regimen</a></strong> (May 7, 2007)</small> <ul> <li><small>Excellent discussion and background</small></li> </ul> <p><small><strong>MedLearn:</strong> <a href= "http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5729.pdf">Unlabeled Use for Anti-Cancer Drugs: Medical Literature used to Determine Medically Accepted Indications for Drugs and Biologicals used in Anti-Cancer Treatment</a>, September 21, 2007</small></p> <p><small><br></small></p> |