<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 20:06:53:45 Clinical review opinion for experimental or investigational treatment reviews.</title> <META NAME="Keywords" Content="Administrative Rules 20:06:53:45"> <META NAME="Description" Content="Administrative Rules 20:06:53:45 Clinical review opinion 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="2006530004500d_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>2</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>268</o:Words> <o:Characters>1530</o:Characters> <o:Company>State of South Dakota</o:Company> <o:Lines>12</o:Lines> <o:Paragraphs>3</o:Paragraphs> <o:CharactersWithSpaces>1795</o:CharactersWithSpaces> <o:Version>10.6870</o:Version> </o:DocumentProperties> </xml><![endif]--><!--[if gte mso 9]><xml> <w:WordDocument> <w:PunctuationKerning/> <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; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-1610611985 1073750139 0 0 159 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-parent:""; margin:0in; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:10.0pt; font-family:"Times New Roman"; mso-fareast-font-family:"Times New Roman";} @page Section1 {size:8.5in 11.0in; margin:1.0in 1.0in 1.0in 1.0in; mso-header-margin:.5in; mso-footer-margin:.5in; mso-paper-source:0;} div.Section1 {page:Section1;} --> </style> <!--[if gte mso 10]> <style> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; 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='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style='mso-bidi-font-weight:normal'>20:06:53:45.&nbsp;&nbsp;Clinical review opinion for experimental or investigational treatment reviews.</b> Except as provided in &#167;&nbsp;20:06:53:44, within 20 days after being selected in accordance with &#167;&#167;&nbsp;20:06:53:39 to 20:06:53:41, inclusive, to conduct the external review, each clinical reviewer shall provide an opinion to the assigned independent review organization pursuant to &#167;&nbsp;20:06:53:47 on whether the recommended or requested health care service or treatment should be covered. Except for an opinion provided pursuant to &#167;&nbsp;20:06:53:46, each clinical reviewer's opinion shall be in writing and include the following information:</p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(1)&nbsp;&nbsp;A description of the covered person's medical condition;</p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(2)&nbsp;&nbsp;A description of the indicators relevant to determining whether there is sufficient evidence to demonstrate that 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 services or treatments 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='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(3)&nbsp;&nbsp;A description and analysis of any medical or scientific evidence, as that term is defined in subdivision 20:06:53:01(28), considered in reaching the opinion;</p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(4)&nbsp;&nbsp;A description and analysis of any evidence-based standard, as that term is defined in subdivision 20:06:53:01(18); and</p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(5)&nbsp;&nbsp;Information on whether the reviewer's rationale for the opinion is based on subsection 20:06:53:47(5)(a) or (b).</p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><o:p>&nbsp;</o:p></p> <p class=MsoNormal style='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><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='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><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='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><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='text-align:justify;tab-stops:.4in .6in .9in 1.1in 1.4in 1.6in 1.9in 2.1in 2.4in 2.6in 2.9in 3.1in 3.4in 3.6in 3.9in 4.1in'><o:p>&nbsp;</o:p></p> </div> </body> </html>