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[](https://www.cms.gov/) Centers for Medicare & Medicaid Services ## [CMS Newsroom](https://www.cms.gov/about-cms/contact/newsroom) CMS Global Secondary Menu - [About CMS](https://www.cms.gov/about-cms) - [Newsroom](https://www.cms.gov/about-cms/contact/newsroom) - [Data & Research](https://www.cms.gov/data-research) ## Search CMS.gov ## CMS.gov main menu - Medicare Back to main menu ## section title h2 - Enrollment & renewal Back to menu ### section title h3 - [Original Medicare (Part A and B) Eligibility and Enrollment](https://www.cms.gov/medicare/enrollment-renewal/original-part-a-b) - [Annual Medicare Participation Announcement](https://www.cms.gov/medicare-participation) - [Providers & suppliers](https://www.cms.gov/medicare/enrollment-renewal/providers-suppliers) - [Medicare Managed Care Eligibility and Enrollment](https://www.cms.gov/medicare/enrollment-renewal/managed-care-eligibility-enrollment) - [Part D Eligibility and Enrollment](https://www.cms.gov/medicare/enrollment-renewal/part-d-enrollment-eligibility) - 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Appeals & grievances Back to menu ### section title h3 - [Original Medicare appeals](https://www.cms.gov/medicare/appeals-grievances/fee-for-service) - [Managed Care appeals & grievances](https://www.cms.gov/medicare/appeals-grievances/managed-care) - [Medicare Prescription drug appeals & grievances](https://www.cms.gov/medicare/appeals-grievances/prescription-drug) - [Ombudsman Center](https://www.cms.gov/medicare/appeals-grievances/ombudsman-center) - [Appeals Decision Search (Part C & Part D)](https://www.cms.gov/medicare/appeals-grievances/appeals-decision-search-part-c-d) - Quality Back to menu ### section title h3 - [Value-based programs](https://www.cms.gov/medicare/quality/value-based-programs) - [Person & Family Engagement](https://www.cms.gov/medicare/quality/initiatives/hospital-quality-initiative/person-family-engagement) - [Quality improvement organizations](https://www.cms.gov/medicare/quality/quality-improvement-organizations) - [Nursing home quality improvement](https://www.cms.gov/medicare/quality/nursing-home-improvement) - [Inpatient Rehabilitation Facility (IRF) Quality Reporting Program (QRP)](https://www.cms.gov/medicare/quality/inpatient-rehabilitation-facility) - [Home Health Quality Reporting Program](https://www.cms.gov/medicare/quality/home-health) - [ESRD Quality Incentive Program](https://www.cms.gov/medicare/quality/end-stage-renal-disease-esrd-quality-incentive-program) - [CMS National Quality Strategy](https://www.cms.gov/medicare/quality/meaningful-measures-initiative/cms-quality-strategy) - [Hospice Quality Reporting Program](https://www.cms.gov/medicare/quality/hospice) - [Long-Term Care Hospital (LTCH) Quality Reporting Program (QRP)](https://www.cms.gov/medicare/quality/long-term-care-hospital) - [Appropriate Use Criteria Program](https://www.cms.gov/medicare/quality/appropriate-use-criteria-program) - [Quality measures](https://www.cms.gov/medicare/quality/measures) - [Medicare Advantage quality improvement program](https://www.cms.gov/medicare/advantage-quality-improvement-program) - [Physician compare initiative](https://www.cms.gov/medicare/quality/physician-compare-initiative) - [Quality initiatives](https://www.cms.gov/medicare/quality/initiatives) - [Part C and D Performance Data](https://www.cms.gov/medicare/health-drug-plans/part-c-d-performance-data) - [Skilled Nursing Facility (SNF) Quality Reporting Program (QRP)](https://www.cms.gov/medicare/quality/snf-quality-reporting-program) - Health & safety standards Back to menu ### section title h3 - [Quality, Safety & Oversight Group (QSOG)](https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-group-qsog) - [Quality, safety & oversight general information](https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information) - [Certification & compliance](https://www.cms.gov/medicare/health-safety-standards/certification-compliance) - [Nursing Homes](https://www.cms.gov/medicare/health-safety-standards/certification-compliance/nursing-homes) - [Enforcement](https://www.cms.gov/medicare/health-safety-standards/certification-compliance/enforcement) - 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[Home Health Agencies](https://www.cms.gov/medicare/health-safety-standards/certification-compliance/home-health-agencies) - [Hospices](https://www.cms.gov/medicare/health-safety-standards/certification-compliance/hospices) - [Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID)](https://www.cms.gov/medicare/health-safety-standards/certification-compliance/intermediate-care-facilities) - [Organ Transplant Program](https://www.cms.gov/medicare/health-safety-standards/certification-compliance/organ-transplant-program) - [Psychiatric Hospitals](https://www.cms.gov/medicare/health-safety-standards/certification-compliance/psychiatric-hospitals) - [Psychiatric Residential Treatment Facility Providers](https://www.cms.gov/medicare/health-safety-standards/certification-compliance/psychiatric-residential-treatment-facility-providers) - [Inpatient Rehabilitation Facilities](https://www.cms.gov/medicare/health-safety-standards/certification-compliance/inpatient-rehabilitation-facilities) - 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[Accreditation programs](https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/accreditation-advanced-diagnostic-imaging-suppliers) - [Conditions for coverage & participation](https://www.cms.gov/medicare/health-safety-standards/conditions-coverage-participation) - [Home Health Agencies](https://www.cms.gov/medicare/health-safety-standards/guidance-for-laws-regulations/home-health-agencies) - Employers & plan sponsors Back to menu ### section title h3 - [Creditable coverage](https://www.cms.gov/medicare/employers-plan-sponsors/creditable-coverage) - IC-Placeholder-1 - Audits & Compliance Back to menu ### section title h3 - [Part A cost report audit](https://www.cms.gov/medicare/audits-compliance/part-a-cost-report) - [Part C/Part D compliance & audits](https://www.cms.gov/medicare/audits-compliance/part-c-d) - Forms & notices Back to menu ### section title h3 - [CMS forms](https://www.cms.gov/medicare/forms-notices/cms-forms) - [CMS forms list](https://www.cms.gov/medicare/forms-notices/cms-forms-list) - 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[Cost plans](https://www.cms.gov/medicare/enrollment-renewal/health-plans/cost) - [Special needs plans](https://www.cms.gov/medicare/enrollment-renewal/special-needs-plans) - [Network adequacy](https://www.cms.gov/medicare/health-drug-plans/network-adequacy) - [Report a provider complaint about an MA plan](https://www.cms.gov/medicare/health-drug-plans/provider-complaints-form) - [Medicare Prescription Payment Plan](https://www.cms.gov/medicare/health-drug-plans/medicare-prescription-payment-plan) - Coordination of benefits & recovery Back to menu ### section title h3 - [Overview](https://www.cms.gov/medicare/coordination-benefits-recovery/overview) - [Mandatory Insurer Reporting for Group Health Plans (GHP)](https://www.cms.gov/medicare/coordination-benefits-recovery/mandatory-insurer-reporting-group-health-plans) - [Mandatory insurer reporting (NGHP)](https://www.cms.gov/medicare/coordination-benefits-recovery/mandatory-insurer-reporting) - [Workers' comp Medicare set aside arrangements](https://www.cms.gov/medicare/coordination-benefits-recovery/workers-comp-set-aside-arrangements) - [Attorney services](https://www.cms.gov/medicare/coordination-benefits-recovery/attorney-services) - [Beneficiary services](https://www.cms.gov/medicare/coordination-benefits-recovery/beneficiary-services) - [COBA Trading Partners](https://www.cms.gov/medicare/coordination-benefits-recovery/coba-trading-partners) - [Employer services](https://www.cms.gov/medicare/coordination-benefits-recovery/employer-services) - [Insurer services](https://www.cms.gov/medicare/coordination-benefits-recovery/insurer-services) - [Prescription drug assistance programs](https://www.cms.gov/medicare/coordination-benefits-recovery/prescription-drug-assistance-programs) - [Provider services](https://www.cms.gov/medicare/coordination-benefits-recovery/provider-services) - Settlements Back to menu ### section title h3 - [Jimmo Settlement](https://www.cms.gov/medicare/settlements/jimmo) - [Ryan Settlement](https://www.cms.gov/medicare/settlements/ryan) - Medicaid/CHIP Back to main menu ## section title h2 - What is Medicaid? Back to menu ### section title h3 - [Visit Medicaid.gov](https://www.medicaid.gov/) - [View Medicaid maps](https://www.medicaid.gov/about-us/beneficiary-resources/index.html#statemenu) - [Visit CHIP.gov](http://www.medicaid.gov/chip/index.html) - Medicare-Medicaid Coordination Back to menu ### section title h3 - [Integrated care resources](https://www.cms.gov/medicaid-chip/medicare-coordination/integrated-care-resources) - [Initiative to reduce avoidable hospitalizations](https://www.cms.gov/medicaid-chip/medicare-coordination/avoidable-hospitalizations) - [Financial alignment initiative](https://www.cms.gov/medicaid-chip/medicare-coordination/financial-alignment) - [Medicaid Integrity Institute](https://www.cms.gov/medicaid-chip/medicare-coordination/integrity-institute) - RG-Placeholder-1 - IC-Placeholder-2 - Community engagement support Back to menu ### section title h3 - [Eligibility made easy (Emmy)](https://www.cms.gov/medicaid-chip/community-engagement-support/eligibility-made-easy) - Marketplace & Private Insurance Back to main menu ## section title h2 - About the Marketplace Back to menu ### section title h3 - [Marketplace oversight](https://www.cms.gov/marketplace/about/oversight) - [Affordable Care Act](https://www.cms.gov/marketplace/about/affordable-care-act) - [Overview of the exchanges](https://www.cms.gov/marketplace/about/overview-exchanges) - [Exchange coverage maps](https://www.cms.gov/marketplace/about/exchange-coverage-maps) - [Medicare and the Marketplace](https://www.cms.gov/marketplace/about/medicare) - [Health Insurance Marketplace quality initiatives](https://www.cms.gov/marketplace/about/health-insurance-marketplace-quality-initiatives) - Private Health Insurance Back to menu ### section title h3 - [Patient’s Bill of Rights](https://www.cms.gov/marketplace/private-health-insurance/patient-bill-of-rights) - [Medical loss ratio](https://www.cms.gov/marketplace/private-health-insurance/medical-loss-ratio) - [Annual limits](https://www.cms.gov/marketplace/private-health-insurance/annual-limits) - 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[About](https://www.cms.gov/priorities/innovation/about) - [Key Concepts](https://www.cms.gov/priorities/innovation/key-concepts) - [Model Data](https://www.cms.gov/priorities/innovation-center/model-data) - [Value-Based Care Spotlight](https://www.cms.gov/priorities/innovation-center/value-based-care-spotlight) - [Innovation Models](https://www.cms.gov/priorities/innovation/models) - [Where Innovation is Happening](https://www.cms.gov/priorities/innovation/where-innovation-happening) - [Evaluations & Research Reports](https://www.cms.gov/priorities/innovation/evaluation-research-reports) - Lookup tools Back to menu ### section title h3 - [Overview](https://www.cms.gov/medicare/quality/value-based-programs/quality-payment-program/lookup-tools) - Make Hospital Food Healthier Pledge Back to menu ### section title h3 - [Overview](https://www.cms.gov/priorities/make-hospital-food-healthier-pledge/overview) - Marketplace Open Enrollment Back to menu ### section title h3 - [Overview](https://www.healthcare.gov/quick-guide/dates-and-deadlines) - 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[Medical bill rights](https://www.cms.gov/medical-bill-rights) - Training & Education Back to main menu ## section title h2 - Medicare Training Back to menu ### section title h3 - [General resources](https://www.cms.gov/training-education/medicare/general-resources) - [Open Enrollment resources](https://www.cms.gov/priorities/key-initiatives/medicare-open-enrollment-partner-resources) - Partner outreach resources Back to menu ### section title h3 - [Partner with CMS](https://www.cms.gov/training-education/partner-outreach-resources/partner-with-cms) - [National Medicare Education Program (NMEP)](https://www.cms.gov/training-education/partner-outreach-resources/national-medicare-education-program-nmep) - [Low-Income Subsidy (LIS) outreach](https://www.cms.gov/training-education/partner-outreach-resources/low-income-subsidy-lis) - [Faith-Based Partners](https://www.cms.gov/training-education/partner-outreach-resources/faith-based) - [Rural Health Partners](https://www.cms.gov/training-education/partner-outreach-resources/rural-health) - 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[Ambulance](https://www.cms.gov/training-education/open-door-forums/ambulance "The Ambulance Open Door Forum (ODF) addresses issues related to the payment, billing, coverage and delivery of services in the ambulance industry.") - [End-Stage Renal Disease (ESRD) Dialysis Facility Care Compare](https://www.cms.gov/training-education/cms-open-door-forums/end-stage-renal-disease-esrd-dialysis-facility-care-compare) - [Home Health, Hospice & Durable Medical Equipment (DME)](https://www.cms.gov/training-education/open-door-forums/home-health-hospice-durable-medical-equipment-dme) - [Hospital](https://www.cms.gov/training-education/open-door-forums/hospitals) - [Long-Term Services & Supports](https://www.cms.gov/training-education/open-door-forums/long-term-services-supports) - [Physicians, Nurses and Allied Health Professionals](https://www.cms.gov/training-education/open-door-forums/physicians-nurses-allied-health-professionals) - [Rural Health](https://www.cms.gov/training-education/open-door-forums/rural-health) - [Skilled Nursing Facilities (SNFs)/Long-Term Care](https://www.cms.gov/training-education/open-door-forums/skilled-nursing-facilities-snf) - [Special Open Door forums](https://www.cms.gov/training-education/open-door-forums/special) - Look up topics Back to menu ### section title h3 - [Medicare](https://www.cms.gov/training-education/partner-outreach-resources/medicare) - [Medicaid](https://www.cms.gov/training-education/partner-outreach-resources/medicaid) - [CHIP](https://www.cms.gov/training-education/partner-outreach-resources/chip) - [American Indian/Alaska Native Center](https://www.cms.gov/training-education/look-up-topics/american-indian-alaska-native-center) - [Quality of care](https://www.cms.gov/training-education/partner-outreach-resources/quality-of-care) - [Special populations](https://www.cms.gov/training-education/partner-outreach-resources/special-populations) - [Fraud & abuse](https://www.cms.gov/training-education/partner-outreach-resources/fraud-abuse) - [States](https://www.cms.gov/training-education/partner-outreach-resources/states) - [Privacy](https://www.cms.gov/training-education/partner-outreach-resources/privacy) - [Health conditions & campaigns](https://www.cms.gov/training-education/partner-outreach-resources/health-conditions-campaigns) - [New Medicare Card](https://www.cms.gov/training-education/partner-outreach-resources/new-medicare-card) - [HIPAA Administrative Simplification](https://www.cms.gov/training-education/look-up-topics/hipaa-administrative-simplification) - Learn More Back to menu ### section title h3 - [Attend events](https://www.cms.gov/training-education/learn/attend-events) - [Find resources](https://www.cms.gov/training-education/learn/find-resources) - [Get training](https://www.cms.gov/training-education/learn/get-training) - [Find tools to help you help others](https://www.cms.gov/training-education/learn/find-tools-to-help-you-help-others) - [Get digital media](https://www.cms.gov/training-education/learn/get-digital-media) - Find your provider type Back to menu ### section title h3 - [Physicians & other health professionals](https://www.cms.gov/training-education/find-provider-type/physicians-other-health-professionals) - [Facilities](https://www.cms.gov/training-education/find-provider-type/facilities) - [Health & drug plans](https://www.cms.gov/training-education/find-provider-type/health-drug-plans) - [Employers & unions](https://www.cms.gov/training-education/find-provider-type/employers-unions) - Medicare - Health & safety standards - Clinical Laboratory Improvement Amendments (CLIA) ## Pages in this section - - - [Clinical Laboratory Improvement Amendments (CLIA)](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments) - - [How to Apply for a CLIA Certificate, Including International Laboratories](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/apply) - [CLIA Accreditation and Testing](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/accreditation-exemptions) - [CLIA Brochures](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/brochures) - [CLIA Regulations and Federal Register Documents](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/regulations-federal-register) - [Individualized Quality Control Plan (IQCP)](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/quality-control) - [Interpretive Guidelines for Laboratories](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/guidelines-laboratories) - [Laboratory Demographics Lookup and Registry](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/laboratory-registry) - [Proficiency Testing Programs](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/proficiency-testing) - [State Agency & CLIA Operations Branch Contacts](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/contacts) - [CLIA Statistical Tables/Graphs](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/statistics) - [CE Courses for Laboratory Directors](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/training) - [Certification Boards for Laboratory Directors of High Complexity Testing](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/certficiation-boards) - [Categorization of Tests](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/cartegorization) # Clinical Laboratory Improvement Amendments (CLIA)  ### Spotlight **CLIA transitioned to a paperless system.** We no longer mail CLIA certificates or paper fee coupons. Additionally, all CLIA certification and survey fees must be paid [online](https://www.pay.gov/public/form/start/55598674) (payments by paper check are no longer accepted). **Laboratories must** have a **valid email address** on file to receive electronic CLIA certificates\*, fee coupons\*, and other CMS communications. **\****This does not apply to CLIA exempt states or state licensure.* **Tip**: Use a business email address, or one that many staffers can access and use. **Need help?** - **Contact your** [**State Agency**](https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliasa.pdf) **or Accreditation Organization** to update your email. - **Refer to the** [**FAQs about the Transition to Paperless**](https://www.cms.gov/files/document/clia-paperless-faq-sheet.pdf), which provide key information to support your laboratory following the transition. **Online** **Laboratories must pay their CLIA certification and survey fees online** though [pay.gov](https://www.pay.gov/public/form/start/55598674), a secure platform hosted by the U.S. Treasury Department. [](https://pay.gov/public/form/start/55598674) [Get Online Payment Info (PDF)](https://www.cms.gov/files/document/paygov-banner-fact-sheet.pdf) *** **Apply for CLIA Certification** Use the **Certification Quick Start Guide** to help you complete the [CMS-116 application](https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms116.pdf). [](https://www.cms.gov/files/document/cms-clia-laboratory-quick-start-guide-remediated.pdf) *** **About CLIA** The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) program. The objective of CLIA is to ensure quality laboratory testing. In 1988, Congress passed CLIA regulations to establish quality standards for all testing laboratories to ensure that all patient test results are: - Accurate - Reliable - Timely CLIA regulations are based on the complexity of the test method. The more complicated the test, the more stringent the requirements. [More information about laboratory test categorization and complexity](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/cartegorization). CLIA covers approximately 320,000 laboratory entities. State Survey Agencies are authorized to set and enforce CLIA standards. Although all laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. *** Contact your [State Agency](https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliasa.pdf) about: - CLIA fees or payment - CMS-116 applications - Demographic updates - Certificate status or upgrades - Laboratory Director changes - [Filing a complaint]() For other questions about the CLIA program, email us at [LabExcellence@cms.hhs.gov](mailto:LabExcellence@cms.hhs.gov). [**Resources**]() **for You** | | | |---|---| | **Apply for a CLIA Certificate**Information about the application process and forms you need to submit[Get Certified](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/apply) | **CLIA Brochures**Helpful resources to learn about CLIA and laboratory requirements[Learn More](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/brochures) | *** ## Downloads - [CLIA Cert Quick Start Guide (PDF)](https://www.cms.gov/files/document/clia-cert-quick-start-guide.pdf) - [BD BACTEC™ Blood Culture Media Bottle Shortage, Frequently Asked Questions (FAQs) -August 29, 2024 (PDF)](https://www.cms.gov/files/document/bd-bactectm-blood-culture-media-bottle-shortage-frequently-asked-questions-faqs-august-29-2024.pdf) - [CLIA Post-PHE Guidance FAQs Only (PDF)](https://www.cms.gov/files/document/clia-post-phe-guidance-faqs-only.pdf) - [CLIA of 1988 Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355-F) FAQ Sheet 7/7/2022 (PDF)](https://www.cms.gov/files/document/clia-1988-proficiency-testing-regulations-related-analytes-and-acceptable-performance-cms-3355-f-faq.pdf) - [LDT and CLIA FAQs 10/22/2013 (PDF)](https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/ldt-and-clia_faqs.pdf) - [Research Testing and CLIA 12/10/2014 (PDF)](https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/research-testing-and-clia.pdf) - [Direct Access Testing 03/22/2019 (PDF)](https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/directaccesstestingpdf.pdf) - [Live Blood Cell Analysis Under CLIA 03/17/2017 (PDF)](https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/special_alert.pdf) - [Form W-9 2026 (PDF)](https://www.cms.gov/files/document/form-w-9-2026.pdf) ## Related Links - [CLIA Fee, Histocompatibility, Personnel, Alternative Sanction, CMS-3326-F, Final Rule, 12/28/2023](https://www.cms.gov/medicare/quality/%20https://www.federalregister.gov/documents/2023/12/28/2023-28170/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and) - [How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices 08/05/2015](https://www.cms.gov/medicare/quality/%20https://wayback.archive-it.org/7993/20170112085432/http:/www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm220292.htm) - [CDC PPMP - A Focus on Quality Practices Booklet](https://www.cms.gov/medicare/quality/%20https://www.cdc.gov/clia/ppm.html) - [CDC Division of Laboratory Systems](https://www.cms.gov/medicare/quality/%20https://www.cdc.gov/clia/) - [Clinical Laboratory Fee Schedule](https://www.cms.gov/medicare/quality/%20/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs) Page Last Modified: 03/10/2026 11:46 PM [Help with File Formats and Plug-Ins](https://www.cms.gov/about-cms/web-policies-important-links/help "Help with File Formats and Plug-Ins") ## Get email updates Sign up to get the latest information about your choice of CMS topics. 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**Online** **Laboratories must pay their CLIA certification and survey fees online** though [pay.gov](https://www.pay.gov/public/form/start/55598674), a secure platform hosted by the U.S. Treasury Department. [](https://pay.gov/public/form/start/55598674) [Get Online Payment Info (PDF)](https://www.cms.gov/files/document/paygov-banner-fact-sheet.pdf) *** **Apply for CLIA Certification** Use the **Certification Quick Start Guide** to help you complete the [CMS-116 application](https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms116.pdf). [](https://www.cms.gov/files/document/cms-clia-laboratory-quick-start-guide-remediated.pdf) *** **About CLIA** The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) program. The objective of CLIA is to ensure quality laboratory testing. In 1988, Congress passed CLIA regulations to establish quality standards for all testing laboratories to ensure that all patient test results are: - Accurate - Reliable - Timely CLIA regulations are based on the complexity of the test method. The more complicated the test, the more stringent the requirements. [More information about laboratory test categorization and complexity](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/cartegorization). CLIA covers approximately 320,000 laboratory entities. State Survey Agencies are authorized to set and enforce CLIA standards. Although all laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. *** Contact your [State Agency](https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliasa.pdf) about: - CLIA fees or payment - CMS-116 applications - Demographic updates - Certificate status or upgrades - Laboratory Director changes - [Filing a complaint]() For other questions about the CLIA program, email us at [LabExcellence@cms.hhs.gov](mailto:LabExcellence@cms.hhs.gov). [**Resources**]() **for You** | | | |---|---| | **Apply for a CLIA Certificate**Information about the application process and forms you need to submit[Get Certified](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/apply) | **CLIA Brochures**Helpful resources to learn about CLIA and laboratory requirements[Learn More](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/brochures) | ***