<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 67:16:14:20 Notice to interested parties before drug placed on list -- Opportunity for interested parties to present data, opinions, and arguments.</title> <META NAME="Keywords" Content="Administrative Rules 67:16:14:20"> <META NAME="Description" Content="Administrative Rules 67:16:14:20 Notice to interested parties before drug placed on list -- Opportunity for interested parties to present data, opinions, and arguments."> <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="6716140002000d_files/filelist.xml"> <!--[if gte mso 9]><xml> <o:DocumentProperties> <o:Author>lrpr14296</o:Author> <o:LastAuthor>lrpr14296</o:LastAuthor> <o:Revision>2</o:Revision> <o:TotalTime>0</o:TotalTime> <o:LastPrinted>2006-03-21T14:30:00Z</o:LastPrinted> <o:Created>2006-03-21T15:02:00Z</o:Created> <o:LastSaved>2006-03-21T15:02:00Z</o:LastSaved> <o:Pages>1</o:Pages> <o:Words>269</o:Words> <o:Characters>1536</o:Characters> <o:Company>State of South Dakota</o:Company> <o:Lines>12</o:Lines> <o:Paragraphs>3</o:Paragraphs> <o:CharactersWithSpaces>1802</o:CharactersWithSpaces> <o:Version>10.4219</o:Version> </o:DocumentProperties> <o:OfficeDocumentSettings> <o:DoNotRelyOnCSS/> </o:OfficeDocumentSettings> </xml><![endif]--><!--[if gte mso 9]><xml> <w:WordDocument> <w:GrammarState>Clean</w:GrammarState> <w:DisplayHorizontalDrawingGridEvery>0</w:DisplayHorizontalDrawingGridEvery> <w:DisplayVerticalDrawingGridEvery>0</w:DisplayVerticalDrawingGridEvery> <w:UseMarginsForDrawingGridOrigin/> <w:Compatibility> <w:FootnoteLayoutLikeWW8/> <w:ShapeLayoutLikeWW8/> <w:AlignTablesRowByRow/> <w:ForgetLastTabAlignment/> <w:LayoutRawTableWidth/> <w:LayoutTableRowsApart/> <w:UseWord97LineBreakingRules/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--> <style> <!-- /* Font Definitions */ @font-face {font-family:Tahoma; panose-1:2 11 6 4 3 5 4 4 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:1627421319 -2147483648 8 0 66047 0;} @font-face {font-family:Times; panose-1:2 2 6 3 5 4 5 2 3 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-format:other; mso-font-pitch:variable; mso-font-signature:3 0 0 0 1 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-parent:""; margin:0in; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:Times; mso-fareast-font-family:"Times New Roman"; mso-bidi-font-family:"Times New Roman";} span.GramE {mso-style-name:""; mso-gram-e:yes;} @page Section1 {size:8.5in 11.0in; margin:49.7pt 1.0in 49.7pt 63.35pt; 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:"Times New Roman";} </style> <![endif]--><!--[if gte mso 9]><xml> <o:shapedefaults v:ext="edit" spidmax="1026"/> </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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style='mso-bidi-font-weight:normal'><span style='font-weight:bold;mso-bidi-font-weight: normal'>67:16:14:20<span class=GramE>&nbsp;&nbsp;Notice</span> to interested parties before drug placed on list -- Opportunity for interested parties to present data, opinions, and arguments.</span></b> Before the Division of Medical Services places a drug on its list of drugs that require prior authorization, the division shall provide an opportunity for interested parties to present data, opinions, and arguments concerning the placement of the drug on the list. The division shall notify interested parties of this opportunity. The notice shall be in writing and shall state where and when an interested party can present data, opinions, and arguments concerning the proposal.<o:p></o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><o:p>&nbsp;</o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>When taking final action on the proposals, the division may accept or reject the P and T committee's recommendations and may consider any information provided to the department by an interested party.<o:p></o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><o:p>&nbsp;</o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>When the division places a drug on the list, an interested party may request that the department secretary review the division's decision. The request for the review must be in writing, made to the department secretary, and made within 30 days following the placement of the drug on the list. The request must contain the following information:<o:p></o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><o:p>&nbsp;</o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(1)&nbsp;&nbsp;The drug's brand name;<o:p></o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(2)&nbsp;&nbsp;A summary, limited to two pages, of the clinical and/or economic reasons why the product should not be included on the list; and<o:p></o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>(3)&nbsp;&nbsp;New information on the drug that has become available since the P and T committee's hearing on the drug.<o:p></o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><o:p>&nbsp;</o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span>The department secretary shall review the required information and determine whether to override the division's decision. The secretary shall provide a written notice of the final action to the interested party requesting the review.<o:p></o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><o:p>&nbsp;</o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style='mso-bidi-font-weight:normal'><span style='font-weight:bold;mso-bidi-font-weight: normal'>Source:</span></b> 32 SDR 154, effective March 22, 2006.<o:p></o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style='mso-bidi-font-weight:normal'><span style='font-weight:bold;mso-bidi-font-weight: normal'>General Authority:</span></b> SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=28-6-1">28-6-1.</A><o:p></o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><span style='mso-tab-count:1'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><b style='mso-bidi-font-weight:normal'><span style='font-weight:bold;mso-bidi-font-weight: normal'>Law Implemented:</span></b> SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=28-6-1">28-6-1.</A><o:p></o:p></span></font></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'><font size=3 face="Times New Roman"><span style='font-size:12.0pt;mso-bidi-font-size: 10.0pt;font-family:"Times New Roman"'><o:p>&nbsp;</o:p></span></font></p> </div> </body> </html>