{"id":27243,"date":"2020-05-13T10:46:34","date_gmt":"2020-05-13T10:46:34","guid":{"rendered":"https:\/\/dev.mtelehealth.com\/?p=27243"},"modified":"2020-05-13T10:46:34","modified_gmt":"2020-05-13T10:46:34","slug":"cms-flexibilities-to-fight-covid-19-cms-sars-cov-2-laboratory-testing-comparison","status":"publish","type":"post","link":"https:\/\/drmiltie.com\/at-home-testing\/cms-flexibilities-to-fight-covid-19-cms-sars-cov-2-laboratory-testing-comparison\/","title":{"rendered":"CMS Flexibilities to Fight COVID-19 &#8211; CMS SARS-CoV-2 Laboratory Testing Comparison"},"content":{"rendered":"\n<div class=\"wp-block-file aligncenter\"><a href=\"https:\/\/mtelehealth.com\/wp-content\/uploads\/2020\/05\/18-CMS-Flexibilities-to-Fight-COVID-19-CMS-SARS-CoV-2-Laboratory-Testing-Comparison-Final.pdf\"><br \/><\/a><a href=\"https:\/\/mtelehealth.com\/wp-content\/uploads\/2020\/05\/18-CMS-Flexibilities-to-Fight-COVID-19-CMS-SARS-CoV-2-Laboratory-Testing-Comparison-Final.pdf\" class=\"wp-block-file__button\" download>Download PDF<\/a><\/div>\n\n\n\n<p><br \/>DEPARTMENT OF HEALTH &amp; HUMAN SERVICES<br \/>Centers for Medicare &amp; Medicaid Services<br \/>7500 Security Boulevard, Mail Stop C2-21-16<br \/>Baltimore, Maryland 21244-1850<br \/>Center for Clinical Standards and Quality\/Quality, Safety &amp; Oversight Group<br \/>Admin Info: 20-06-CLIA<br \/>DATE: April 30, 2020<br \/>TO: State Survey Agency Directors<br \/>FROM: Director<br \/>Quality, Safety &amp; Oversight Group<br \/>SUBJECT: CMS SARS-CoV-2 Laboratory Testing Comparison<br \/>Background:<br \/>CMS is committed to taking critical steps to ensure America\u2019s clinical laboratories can respond to the threat of COVID-19 and other respiratory illnesses to protect patient health and safety. The intent of the CLIA program is to ensure that test results provided to individuals and their health care providers are accurate and reliable.<br \/>Laboratories need a CLIA certificate to perform SARS-CoV-2 testing. Under CLIA, laboratories are prohibited from testing human specimens for the purpose of diagnosis, prevention, treatment, or health assessment without a valid CLIA certificate. Clinical laboratories and facilities such as academic laboratories, research laboratories, pharmacies, physician offices, urgent care clinics, and veterinary laboratories need CLIA certification to perform SARS-CoV-2 testing on human specimens.<br \/>Memorandum Summary<br \/>\u2022 CMS is committed to taking critical steps to ensure America\u2019s clinical laboratories can respond to the threat of the 2019 Novel Coronavirus (COVID-19) and other respiratory illnesses to ensure patient health and safety.<br \/>\u2022 Laboratories need a Clinical Laboratory Improvement Amendments (CLIA) certificate to perform severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing. Under CLIA, laboratories are prohibited from testing human specimens for the purpose of diagnosis, prevention, treatment, or health assessment without a valid CLIA certificate. This also applies to facilities not typically considered to be laboratories that are performing SARS-CoV-2 testing.<br \/>\u2022 This guidance is a part of the Centers for Medicare &amp; Medicaid Services (CMS) effort to clarify:<br \/>o The types of severe acute respiratory syndrome coronavirus 2<br \/>(SARS-CoV-2) testing and whether the tests are being offered under an Emergency Use Authorization (EUA) issued by FDA or as described in FDA\u2019s COVID-19 Test Guidance<br \/>o The CLIA certifications under which each test can be performed<br \/>o An explanation of requirements under each testing scenario<br \/>o Information for Medicare beneficiaries on testing services and coverage<br \/>This guidance is part of the CMS effort to clarify the types of SARS-CoV-2 testing, whether the tests are being offered under an EUA issued by FDA or as described in FDA\u2019s COVID-19 Test Guidance, the CLIA certifications and requirements under which testing can be performed, and information for Medicare beneficiaries on testing services and coverage.<br \/>Guidance:<br \/>This guidance is intended to clarify the different types of testing available for laboratories, whether the tests are being offered under an EUA issued by FDA or as described in FDA\u2019s COVID-19 Test Guidance for these tests systems, and the CLIA certificates under which testing can be performed. As of today, there are two different types of SARS-CoV-2 testing. One type is molecular, which detects nucleic acid from SARS-CoV-2. The other type is serology, or antibody testing, which measures SARS-CoV-2 antibodies present in the blood. There is a third type of SARS-CoV-2 test which detect antigens present in the blood. As of today, no antigen tests for SARS-CoV-2 have been authorized by FDA. Such tests will be added to the FDA website when authorized.<br \/>Currently, COVID-19 tests are being offered that have been FDA authorized under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) (these are listed on the FDA website here.) or under the policies outlined in the FDA&#8217;s Policy for Diagnostic Tests for Coronavirus Disease-2019 (\u201cCOVID-19 Test Guidance\u201d). This document discusses policies applicable to testing for COVID-19, including Laboratory Developed Tests (LDTs). \u201cFDA notification\u201d means that the laboratory or manufacturer has provided FDA with notification that it has validated its test as described in the policies outlined in FDA\u2019s COVID-19 Test Guidance and is now listed on the FDA website here.<br \/>Further, an explanation of covered testing services for beneficiaries and payment rates for SARS-CoV-2 tests under Medicare is included with this information.<br \/>CMS has received many questions about which assays can be performed under which type of CLIA certificate. This document delineates which assays offered can be performed by laboratories under each of the CLIA Certificate types. CLIA has four different certificate types, which are Certificate of Waiver, Certificate of Provider-Performed Microscopy, Certificate of Compliance, and Certificate of Accreditation. The required certificate type depends on whether the test was issued an EUA, and if so, the authorized settings included in the Emergency Use Authorization (EUA).<br \/>For information about CMS\u2019 response to the COVID-19 public health emergency, please refer to our CMS QSO 20-21-CLIA guidance document and CMS CLIA COVID-19 FAQs<br \/>Contact: For questions or concerns relating to this memorandum, please contact LabExcellence@cms.hhs.gov<br \/>Effective Date: Immediately. This policy should be communicated with all survey and certification staff, their managers and the State\/Regional Office training coordinators within 30 days of this memorandum.<br \/>\/s\/<br \/>David R. Wright<br \/>cc: Survey &amp; Operations Group (SOG) Management<br \/>Attachments: CMS COVID-19 Testing Infographic<br \/>TYPE OF SARS-CoV-2<br \/>TESTING<br \/>FDA AUTHORIZATION\/<br \/>NOTIFICATION<br \/>CLIA CERTIFICATES<br \/>UNDER WHICH TESTING<br \/>CAN BE PERFORMED REQUIREMENTS<br \/>Test authorized under EUA for<br \/>point-of-care (deemed Waived)<br \/>May be performed under all<br \/>certificate types<br \/>\u2022 Perform testing as per<br \/>Manufacturer\u2019s Instruction (MI)<br \/>\u2022 Perform Quality Control as per MI<br \/>\u2022 No personnel requirements<br \/>Test authorized under EUA<br \/>for high and\/or moderate<br \/>complexity<br \/>Certificate of Compliance<br \/>Certificate of Accreditation<br \/>Must meet requirements for Moderate<br \/>or High Complexity Testing, depending<br \/>upon test complexity or setting, as<br \/>authorized in EUA<br \/>FDA notified,** but test is not<br \/>FDA authorized under EUA<br \/>Certificate of Compliance<br \/>Certificate of Accreditation<br \/>Must meet requirements for High<br \/>Complexity Testing (regardless of<br \/>whether manufacturer intends for test<br \/>to be point-of-care\/waived)<br \/>Test not authorized under<br \/>EUA and FDA NOT notified<br \/>LDT authorized under EUA Certificate of Compliance<br \/>Certificate of Accreditation<br \/>Must meet requirements for<br \/>High Complexity Testing<br \/>FDA notified, ** but LDT not<br \/>authorized under EUA<br \/>Certificate of Compliance<br \/>Certificate of Accreditation<br \/>Must meet requirements for<br \/>High Complexity Testing<br \/>LDT authorized by State<br \/>Authority through a<br \/>State Approved Program<br \/>Certificate of Compliance<br \/>Certificate of Accreditation<br \/>Must meet requirements for<br \/>High Complexity Testing<br \/>LDT not authorized under<br \/>EUA or State Authority and<br \/>FDA NOT NOTIFIED<br \/>AT-HOME At-Home Specimen Collection<br \/>and Testing<br \/>Email: FDA-COVID-19-Fraudulent-Products@fda.hhs.gov<br \/>Home specimen collection or home testing is not permitted unless explicitly<br \/>authorized under EUA<br \/>LABORATORY<br \/>DEVELOPED<br \/>TESTS (LDTs)<br \/>In vitro diagnostic<br \/>test that is designed,<br \/>manufactured and<br \/>used within a single<br \/>laboratory; can be<br \/>a molecular, serology,<br \/>or antigen test<br \/>CMS CLINICAL LABORATORY<br \/>IMPROVEMENT AMENDMENTS (CLIA):<br \/>TESTING<br \/>REQUIREMENTS<br \/>FOR SARS-CoV-2<br \/>Last updated April 29, 2020; information subject<br \/>to change based on FDA authorizations and updates<br \/>Laboratories performing testing must be CLIA certified.*<br \/>To apply for CLIA certification, refer to our brochure<br \/>See pages 2 and 3 for more on expansion of testing<br \/>and specimen collection sites and Medicare\n<br \/>payment updates<br \/>TEST KITS<br \/>Molecular tests detect<br \/>nucleic acid from<br \/>SARS-CoV-2<br \/>Serology tests detect<br \/>SARS-CoV-2 antibodies<br \/>present in the blood<br \/>Antigen tests detect<br \/>SARS-CoV-2 antigens<br \/>present in the blood<br \/>Required certificate type<br \/>depends on authorized<br \/>settings included<br \/>in Emergency Use<br \/>Authorization (EUA)<br \/>*Laboratories and facilities such as academic laboratories, research laboratories, pharmacies, and veterinary laboratories would need CLIA certification to perform SARS-CoV-2 testing<br \/>**FDA notified means that the laboratory or manufacturer has notified FDA as described in FDA\u2019s COVID-19 Test Guidance and is now listed on the FDA website here<br \/>Email: FDA-COVID-19-Fraudulent-Products@fda.hhs.gov<br \/>DOCTOR\u2019S OFFICE,<br \/>HOSPITAL<br \/>\u2022 Medicare is separately paying hospitals and practitioners to assess patients and collect<br \/>laboratory samples for COVID-19 testing even when that is the only service the patient receives.<br \/>This approach supports both hospitals and physician practices to operate testing sites.<br \/>\u2022 To ensure that Medicare beneficiaries have broad access to testing, for Medicare payment<br \/>purposes, Medicare no longer requires an order from the treating physician or other<br \/>practitioner for beneficiaries to get both COVID-19 testing and laboratory tests for influenza<br \/>and respiratory syncytial virus that may be part of a COVID-19 diagnosis. COVID-19 tests may<br \/>be covered when ordered by any healthcare professional authorized to do so under state law.<br \/>\u2022 Medicare is covering serology (or antibody) tests, which may be helpful for patients,<br \/>practitioners, and communities in making decisions on medical treatment and responsible<br \/>social distancing policies.<br \/>HOME (INCLUDING<br \/>NURSING HOMES)<br \/>\u2022 For beneficiaries who are homebound and unable to travel, Medicare pays labs to send<br \/>technicians to a beneficiary\u2019s home, including a nursing home when a beneficiary is not in a<br \/>Part A skilled nursing stay, to collect a lab sample.<br \/>\u2022 A home health nurse could collect a lab sample as part of a normal visit for beneficiaries<br \/>receiving home health services.<br \/>\u2022 A visiting nurse working for a Rural Health Clinic or Federally Qualified Health Center and<br \/>making a home visit can collect a lab sample under certain conditions.<br \/>PHARMACY \u2022 Medicare will pay for COVID-19 tests performed by pharmacists as part of a Medicareenrolled<br \/>laboratory.<br \/>\u2022 A pharmacist also may furnish basic clinical services, such as collect lab samples, under<br \/>contract with a doctor or practitioner, in accordance with a pharmacist\u2019s scope of practice<br \/>and state law.<br \/>\u2022 Beneficiaries can get tested at \u201cparking lot\u201d test sites operated by pharmacies consistent<br \/>with state requirements.<br \/>DRIVE-THROUGH<br \/>TESTING OR<br \/>ALTERNATIVE SITES<br \/>\u2022 Healthcare facilities like hospitals, doctor\u2019s offices, labs can set up off-site locations like<br \/>drive- through testing to collect samples. Medicare pays these healthcare providers as they<br \/>normally would.<br \/>CMS ACTIONS<br \/>TO EXPAND<br \/>SARS-CoV-2<br \/>TESTING<br \/>WHERE MEDICARE BENEFICIARIES CAN GET TESTED<br \/>LAB SERVICE MEDICARE PAYMENT BILLING CODE<br \/>CDC RNA Based Lab Test Approx. $36 HCPCS code U0001<br \/>Non- CDC Lab Test that uses any<br \/>technique, multiple types or subtypes<br \/>(includes all targets)<br \/>Approx. $51 HCPCS code U0002<br \/>Non CDC Lab Test using RNA<br \/>based technique<br \/>Approx. $51 CPT code 87635<br \/>Serology (antibody) test TBD CPT code 86328<br \/>CPT code 86769<br \/>Lab Test Using High<br \/>Through-Put Technology<br \/>$100<br \/>(effective 4\/14)<br \/>HCPCS code U0003;<br \/>HCPCS code U0004<br \/>Lab Specimen Collection<br \/>from a Patient<br \/>Approx $23-$25 HCPCS code C9803 billed by hospital<br \/>outpatient department<br \/>HCPCS code 99211 billed<br \/>by a physician office<br \/>HCPCS code G2023\/G2024<br \/>for home\/nursing home collection<br \/>by a lab or on behalf of a home<br \/>health agency<br \/>MEDICARE<br \/>PAYMENT FOR<br \/>LAB SERVICES<br \/>MEDICARE PAYMENT FOR LAB SERVICES<\/p>\n\n\n","protected":false},"excerpt":{"rendered":"<p>DEPARTMENT OF HEALTH &amp; HUMAN SERVICESCenters for Medicare &amp; Medicaid Services7500 Security Boulevard, Mail Stop 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