<html> <head> <title>Rule 67:16:14:01 Definitions.</title> <META NAME="Keywords" Content="Administrative Rules 67:16:14:01"> <META NAME="Description" Content="Administrative Rules 67:16:14:01 Definitions."> <meta http-equiv=Content-Type content="text/html; charset=windows-1252"> <meta name=Generator content="Microsoft Word 10 (filtered)"> <style> <!-- /* Font Definitions */ @font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {margin:0in; margin-bottom:.0001pt; font-size:12.0pt; font-family:"Times New Roman";} @page Section1 {size:8.5in 11.0in; margin:1.0in 1.0in 1.0in 1.0in;} div.Section1 {page:Section1;} --> </style> </head> <body lang=EN-US> <div class=Section1> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b><span style='font-weight:bold'>67:16:14:01.&nbsp;&nbsp;Definitions.</span></b> Terms defined in SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11-2">36-11-2</A> have the same meaning when used in this chapter. In addition, terms used in this chapter mean:</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (1)&nbsp;&nbsp;&quot;Bioavailability,&quot; the degree to which a drug or other substance becomes available to the target tissue after administration;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (2)&nbsp;&nbsp;&quot;Brand name,&quot; an arbitrarily adopted name that is given by a manufacturer to a drug to distinguish it as produced or sold by the manufacturer and which may be used and protected as a trademark;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (3)&nbsp;&nbsp;&quot;Compounded medication,&quot; a therapeutic product prescribed by a licensed practitioner requiring the mixing together of two or more substances by the pharmacist or prescriber;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (4)&nbsp;&nbsp;&quot;Consolidated price,&quot; a replacement for average wholesale price calculated according to the guidelines provided in the South Dakota Medicaid State Plan;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (5)&nbsp;&nbsp;&quot;Contractor,&quot; a vendor that has a contract with the department to provide a list of drugs that are widely and consistently available to South Dakota pharmacies at a price that is less than the consolidated price;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (6)&nbsp;&nbsp;&quot;Cost,&quot; for all drugs and supplies, the actual amount paid by the dispensing provider to the supplier after all discounts are deducted;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (7)&nbsp;&nbsp;&quot;Estimated acquisition cost,&quot; for all drugs not subject to the federal upper limit pricing covered under the provisions of subdivision 67:16:14:06(3) or the state maximum allowable cost covered under the provisions of subdivision 67:16:14:06(4), the consolidated cost of the drug less 13 percent;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (8)&nbsp;&nbsp;&quot;Generic drugs,&quot; drugs of similar chemical composition available from multiple sources and not protected by trademark registration;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (9)&nbsp;&nbsp;&quot;Legend drugs,&quot; drugs which may be dispensed by prescription only;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (10)&nbsp;&nbsp;&quot;Maintenance drugs,&quot; a medication that has been dispensed three times in the same strength, regardless of dosage schedule, in any combination of brand name or generic form, and used in the treatment of a chronic health condition;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (11)&nbsp;&nbsp;&quot;Multiple-source drug,&quot; a drug that is sold in therapeutically equivalent forms under one or more brand names, available from two or more generic distributors, and available from one or more drug wholesale firms located in South Dakota;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (12)&nbsp;&nbsp;&quot;Nonlegend drugs,&quot; drugs and supplies available without a prescription;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (13)&nbsp;&nbsp;&quot;Over-the-counter&quot; or &quot;OTC,&quot; drugs available without a prescription which have been recommended by the P and T committee for coverage under the medical services program;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (14)&nbsp;&nbsp;&quot;Pharmaceutical and therapeutics committee&quot; or &quot;P and T committee,&quot; the South Dakota medicaid pharmaceutical and therapeutics committee established under the provisions of Executive Order 2005-09;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (15)&nbsp;&nbsp;&quot;Pharmacist,&quot; a person licensed to practice pharmacy under SDCL chapter <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11">36-11</A> or by the state in which the pharmacist is located;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (16)&nbsp;&nbsp;&quot;Pharmacy,&quot; a facility defined as a pharmacy under SDCL chapter <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11">36-11</A> or by the state in which it is located;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (17)&nbsp;&nbsp;&quot;PHS provider,&quot; an entity which participates as a public health service provider under the provisions of 42 U.S.C. &#167;&nbsp;256b(a)(4), except &#167;&nbsp;256b(a)(4)(C), as in effect on October 1, 1995, and provides covered drugs on an outpatient basis to an individual who is a patient of the PHS provider. Entities operated by state or local government are not considered PHS providers;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (18)&nbsp;&nbsp;&quot;State MAC list&quot; or &quot;state maximum allowable cost,&quot; the maximum allowable cost established by the department, in consultation with the contractor, for drugs listed on the state MAC list and covered under the provisions of this chapter;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (19)&nbsp;&nbsp;&quot;Therapeutically equivalent,&quot; drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration with comparable bioavailability; and</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; (20)&nbsp;&nbsp;&quot;Trademark,&quot; a device or word which points distinctly to the origin or ownership of the drug to which it is applied and whose exclusive use is legally reserved to the owner.</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b><span style='font-weight:bold'>Source:</span></b> SL 1975, ch 16, &#167;&nbsp;1; 1 SDR 77, effective May 29, 1975; 7 SDR 66, 7 SDR 89, effective July 1, 1981; 13 SDR 8, effective August 3, 1986; 14 SDR 46, effective September 28, 1987; 14 SDR 153, effective May 23, 1988; 16 SDR 234, effective July 1, 1990; 22 SDR 93, effective January 7, 1996; 29 SDR 113, effective February 13, 2003; 31 SDR 21, effective August 25, 2004; 34 SDR 68, effective September 12, 2007; 36 SDR 215, effective July 1, 2010; 36 SDR 215, adopted June 11, 2010, effective July 1, 2011; 37 SDR 236, effective June 28, 2011; 37 SDR 236, adopted June 8, 2011, effective July 1, 2012; 39 SDR 15, effective August 6, 2012.</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b><span style='font-weight:bold'>General Authority:</span></b> SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=28-6-1">28-6-1</A>, <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=21">21</A> U.S.C. 801, 812.</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b><span style='font-weight:bold'>Law Implemented:</span></b> SDCL <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=28-6-1">28-6-1</A>, <A HREF="/statutes/DisplayStatute.aspx?Type=Statute&Statute=21">21</A> U.S.C. 801, 812.</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; <b><span style='font-weight:bold'>Reference:</span></b> <b><span style='font-weight: bold'>South Dakota Medicaid State Plan</span></b>, Attachment 4.19-B, page 20. Copies may be obtained from the Department of Social Services, Division of Medical Services, 700 Governors Drive, Pierre, South Dakota 57501.</span></font></p> <p class=MsoNormal style='text-align:justify'><font size=3 face="Times New Roman"><span style='font-size:12.0pt'>&nbsp;</span></font></p> </div> </body> </html>