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<p class="MsoNormal"><b><span style="font-size:16.0pt;color:#1F497D">Information Provided by MMCAP o previous email sent;</span></b><b><span style="font-size:16.0pt"><o:p></o:p></span></b></p>
<p class="MsoNormal"><span style="font-size:12.0pt;font-family:"Arial",sans-serif;color:#1F497D"><o:p> </o:p></span></p>
<p class="MsoNormal">Here is the <span style="color:#1F497D">waiver by the FDA, </span>
information/links from the FDA…..<o:p></o:p></p>
<p class="MsoNormal"> <o:p></o:p></p>
<p class="MsoNormal" style="mso-margin-top-alt:auto;mso-margin-bottom-alt:auto">FDA issued a policy stating that these types of blood tests can be distributed without formal FDA approval, as long as other recommendations are met. See Policy for Diagnostic
Tests for Coronavirus Disease-2019 during the Public Health Emergency,” available at:
<a href="https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Furldefense.proofpoint.com%2Fv2%2Furl%3Fu%3Dhttps-3A__www.fda.gov_regulatory-2Dinformation_search-2Dfda-2Dguidance-2Ddocuments_policy-2Ddiagnostic-2Dtests-2Dcoronavirus-2Ddisease-2D2019-2Dduring-2Dpublic-2Dhealth-2Demergency%26d%3DDwMGaQ%26c%3DsdnEM9SRGFuMt5z5w3AhsPNahmNicq64TgF1JwNR0cs%26r%3DtfvB9GIfwa5UrVz7Q6FDUN2MqD7j9Ks3u0Nj3joAjhc%26m%3Ds-Xqe81RI7009L6G2avoGkhZUgeWM7W6RxVqu2PWEAE%26s%3DxSzRqAzNqHL-IzJBDzWZtzpAhqaHxtmiKndnaldSt_I%26e%3D&data=02%7C01%7Ckim.hankins%40state.mn.us%7C5fab1d2e46df43f3584d08d7d6837628%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637213732417612033&sdata=zFckHqrEH8R3HPhvp66GVTYcXv9LqUxUa2irl%2FKRxhk%3D&reserved=0" target="_blank">
<span style="color:blue">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency</span></a>. The tests are being marketed based on FDA’s new policy. See FDA
Website, <a href="https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Furldefense.proofpoint.com%2Fv2%2Furl%3Fu%3Dhttps-3A__www.fda.gov_medical-2Ddevices_emergency-2Dsituations-2Dmedical-2Ddevices_faqs-2Ddiagnostic-2Dtesting-2Dsars-2Dcov-2D2-3Futm-5Fcampaign-3D2020-2D03-2D20-2520Mar-252020-2520Update-253A-2520New-2520Information-2520on-2520Diagnostic-2520Testing-2520for-2520SARS-2DCoV-2D2-26utm-5Fmedium-3Demail-26utm-5Fsource-3DEloqua-23whatserologytest%26d%3DDwMGaQ%26c%3DsdnEM9SRGFuMt5z5w3AhsPNahmNicq64TgF1JwNR0cs%26r%3DtfvB9GIfwa5UrVz7Q6FDUN2MqD7j9Ks3u0Nj3joAjhc%26m%3Ds-Xqe81RI7009L6G2avoGkhZUgeWM7W6RxVqu2PWEAE%26s%3D7H6hv4w1JmoZlF872QfoDcvqDZOtV6OlPltXfQgpZqA%26e%3D&data=02%7C01%7Ckim.hankins%40state.mn.us%7C5fab1d2e46df43f3584d08d7d6837628%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637213732417612033&sdata=6%2BmW4zgOiRWRsLXfe2ngA0LEYzWuL56N95XhIfM%2F1xI%3D&reserved=0" target="_blank">
<span style="color:blue">https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2?utm_campaign=2020-03-20%20Mar%2020%20Update%3A%20New%20Information%20on%20Diagnostic%20Testing%20for%20SARS-CoV-2&utm_medium=email&utm_source=Eloqua#whatserologytest</span></a>
<o:p></o:p></p>
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<p class="MsoNormal"><b><span style="font-family:"Arial",sans-serif">Wednesday, April 1, 2020</span></b><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif"> </span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif">To: MMCAP Infuse State Contacts, Advisory Board, Staff, Sr. Account Executives</span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif">Re: MMCAP Infuse COVID-19 Tests</span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif"> </span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif">Good afternoon,</span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif"> </span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif">MMCAP Infuse has executed contract amendments with two of our medical supply distributors to offer COVID-19 testing kits to members.</span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif"> </span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif">Contract # MMS18008 with Concordance Healthcare Solutions LLC has been amended to include:</span><o:p></o:p></p>
<p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:39.05pt;mso-add-space:auto;text-indent:-.25in;line-height:105%;mso-list:l0 level1 lfo2">
<![if !supportLists]><span style="font-family:Symbol"><span style="mso-list:Ignore">·<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><span style="font-family:"Arial",sans-serif">Accutest Coronavirus (2019-nCoV) IgM & IgC Test from Jant Pharmacal Corporation – item number ID29000)</span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif"> </span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif">Contract # MMS18016 with Henry Schein Medical has been amended to include:</span><o:p></o:p></p>
<p class="MsoNormalCxSpMiddle" style="mso-margin-top-alt:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:39.05pt;mso-add-space:auto;text-indent:-.25in;line-height:105%;mso-list:l0 level1 lfo2">
<![if !supportLists]><span style="font-family:Symbol"><span style="mso-list:Ignore">·<span style="font:7.0pt "Times New Roman"">
</span></span></span><![endif]><span style="font-family:"Arial",sans-serif">Standard Q-Covid-19 IgM/IgG Duo Test (20 Tests) – item number 1397701</span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif"> </span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif">As a reminder, contract # MMS14028 with Premier Biotech was previously amended to offer COVID-19 testing kits.</span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif"> </span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif">These tests are
<b>authorized</b> by the FDA, but are not yet approved, since the accuracy has not been tested. In its effort to expedite the process of getting Point of Care test kits to facilities,
<span style="background:yellow;mso-highlight:yellow">the FDA waived the CLIA certification and allowed use of the kits.</span></span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif"> </span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif">Please let us know if you have any questions and thank you for choosing MMCAP Infuse.</span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif"> </span><o:p></o:p></p>
<p class="MsoNormal"> <o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif;color:#414042"> </span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif;color:#414042"> </span><o:p></o:p></p>
<p class="MsoNormal"><b><span style="font-size:12.0pt;font-family:"Georgia",serif;color:#003865">Jared Huizenga
</span></b><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif;color:#414042">BS, Mass Communication</span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif;color:#414042">COMMUNICATIONS COORDINATOR</span><o:p></o:p></p>
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<p class="MsoNormal"><b><span style="font-size:12.0pt;font-family:"Georgia",serif;color:#003865"><image002.jpg><o:p></o:p></span></b></p>
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<p class="MsoNormal"><span style="font-family:"Arial",sans-serif;color:#414042">651.201.3109
</span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif;color:#414042"> </span><o:p></o:p></p>
<p class="MsoNormal"><span style="font-family:"Arial",sans-serif;color:#78BE21">Connect With Us</span><o:p></o:p></p>
<p class="MsoNormal"><u><span style="font-family:"Arial",sans-serif;color:#414042"><a href="https://gcc01.safelinks.protection.outlook.com/?url=https%3A%2F%2Flinktr.ee%2FMMCAPInfuse&data=02%7C01%7Ckim.hankins%40state.mn.us%7C5fab1d2e46df43f3584d08d7d6837628%7Ceb14b04624c445198f26b89c2159828c%7C0%7C0%7C637213732417621989&sdata=ILosIMKWQl3Jiy50msHlmv%2BiqMUy9X%2By6PHkaugwdfQ%3D&reserved=0" target="_blank"><span style="color:#414042">https://linktr.ee/MMCAPInfuse</span></a></span></u><o:p></o:p></p>
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