<html xmlns:v="urn:schemas-microsoft-com:vml" xmlns:o="urn:schemas-microsoft-com:office:office" xmlns:w="urn:schemas-microsoft-com:office:word" xmlns="http://www.w3.org/TR/REC-html40"> <head> <title>Rule 20:06:53:47 Clinical review criteria for experimental or investigational treatment reviews.</title> <META NAME="Keywords" Content="Administrative Rules 20:06:53:47"> <META NAME="Description" Content="Administrative Rules 20:06:53:47 Clinical review criteria for experimental or investigational treatment reviews."> <meta http-equiv=Content-Type content="text/html; charset=windows-1252"> <meta name=ProgId content=Word.Document> <meta name=Generator content="Microsoft Word 10"> <meta name=Originator content="Microsoft Word 10"> <link rel=File-List href="2006530004700d_files/filelist.xml"> <!--[if gte mso 9]><xml> <o:DocumentProperties> <o:Author>lrpr14533</o:Author> <o:LastAuthor>lrpr14296</o:LastAuthor> <o:Revision>2</o:Revision> <o:TotalTime>0</o:TotalTime> <o:Created>2011-07-13T13:59:00Z</o:Created> <o:LastSaved>2011-07-13T13:59:00Z</o:LastSaved> <o:Pages>1</o:Pages> <o:Words>328</o:Words> <o:Characters>1872</o:Characters> <o:Company>State of South Dakota</o:Company> <o:Lines>15</o:Lines> <o:Paragraphs>4</o:Paragraphs> <o:CharactersWithSpaces>2196</o:CharactersWithSpaces> <o:Version>10.6870</o:Version> </o:DocumentProperties> </xml><![endif]--><!--[if gte mso 9]><xml> <w:WordDocument> <w:PunctuationKerning/> <w:DrawingGridHorizontalSpacing>5.5 pt</w:DrawingGridHorizontalSpacing> <w:DisplayHorizontalDrawingGridEvery>2</w:DisplayHorizontalDrawingGridEvery> <w:DisplayVerticalDrawingGridEvery>2</w:DisplayVerticalDrawingGridEvery> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--> <style> <!-- /* Font Definitions */ @font-face {font-family:Calibri; 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mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:Calibri;} </style> <![endif]--><!--[if gte mso 9]><xml> <o:shapedefaults v:ext="edit" spidmax="2050"/> </xml><![endif]--><!--[if gte mso 9]><xml> <o:shapelayout v:ext="edit"> <o:idmap v:ext="edit" data="1"/> </o:shapelayout></xml><![endif]--> </head> <body lang=EN-US style='tab-interval:.5in'> <div class=Section1> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style='mso-bidi-font-weight:normal'>20:06:53:47.&nbsp;&nbsp;Clinical review criteria for experimental or investigational treatment reviews.</b> In addition to the documents and information provided pursuant to &#167;&#167;&nbsp;20:06:53:33 to 20:06:53:35, inclusive, or &#167;&nbsp;20:06:53:42, each clinical reviewer selected pursuant to &#167;&#167;&nbsp;20:06:53:39 to 20:06:53:41, inclusive, to the extent the information or documents are available and the reviewer considers appropriate, shall consider in reaching an opinion pursuant to &#167;&#167;&nbsp;20:06:53:45 and 20:06:53:46, the following:</p> <p class=MsoNormal style='margin-left:0in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(1)&nbsp;&nbsp;The covered person's pertinent medical records;</p> <p class=MsoNormal style='margin-left:0in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(2)&nbsp;&nbsp;The attending physician or health care professional's recommendation;</p> <p class=MsoNormal style='margin-left:0in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(3)&nbsp;&nbsp;Consulting reports from appropriate health care professionals and other documents submitted by the health carrier, covered person, the covered person's authorized representative, or the covered person's treating physician or health care professional;</p> <p class=MsoNormal style='margin-left:0in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(4)&nbsp;&nbsp;The terms of coverage under the covered person's health benefit plan with the health carrier to ensure that, but for the health carrier's determination that the recommended or requested health care service or treatment that is the subject of the opinion is experimental or investigational, the reviewer's opinion is not contrary to the terms of coverage under the covered person's health benefit plan with the health carrier; and</p> <p class=MsoNormal style='margin-left:0in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(5)&nbsp;&nbsp;Whether:</p> <p class=MsoNormal style='margin-left:0in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:2'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(a)&nbsp;&nbsp;The recommended or requested health care service or treatment has been approved by the federal Food and Drug Administration, if applicable, for the condition; or</p> <p class=MsoNormal style='margin-left:0in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:2'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(b)&nbsp;&nbsp;Medical or scientific evidence or evidence-based standards demonstrate that the expected benefits of the recommended or requested health care service or treatment is more likely than not to be beneficial to the covered person than any available standard health care service or treatment and the adverse risks of the recommended or requested health care service or treatment would not be substantially increased over those of available standard health care services or treatments.</p> <p class=MsoNormal style='margin-left:0in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style='mso-bidi-font-weight:normal'>Source:</b> 37 SDR 48, effective September 22, 2010; 37 SDR 241, effective July 1, 2011.</p> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style='mso-bidi-font-weight:normal'>General Authority:</b> SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=58-17-87">58-17-87</A>, <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=58-17H-49">58-17H-49</A>, <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=58-17I-16">58-17I-16</A>, <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=58-18-79">58-18-79.</A></p> <p class=MsoNormal style='margin-left:0in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style='mso-bidi-font-weight:normal'>Law Implemented:</b> SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=58-17-87">58-17-87</A>, <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=58-18-79">58-18-79.</A></p> <p class=MsoNormal style='margin-left:0in'><o:p>&nbsp;</o:p></p> </div> </body> </html>