Skip to main content

An official website of the United States government

Here's how you know

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

CMS.gov
Centers for Medicare & Medicaid Services

CMS Newsroom

Header
  • About CMS
  • Newsroom
  • Data & Research

Search CMS.gov

Popular terms
  • Physician Fee Schedule
  • Local Coverage Determination
  • Medically Unlikely Edits
  • Telehealth
  • Covid-19

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
      • Annual Medicare Participation Announcement
      • Providers & suppliers
      • Medicare Managed Care Eligibility and Enrollment
      • Part D Eligibility and Enrollment
      • Health plans
    • Coverage
      Back to menu

      section title h3

      • PrEP
      • Coverage Determination Process
      • Medicare Coverage Database
      • Approved facilities, trials, & registries
      • Telehealth
      • Medicare Summary Notice
      • Prescription drug coverage contracting
      • Coverage with evidence development
      • Investigational device exemption studies
      • Prescription drug coverage
      • Drug coverage claims data
      • Dental coverage
      • Preventive Services
      • Medicare Coverage Center
      • End Stage Renal Disease (ESRD) Center
      • Ambulances Services Center
    • Regulations & guidance
      Back to menu

      section title h3

      • Manuals
      • Transmittals
      • CMS Records Schedule
      • Medicare Fee-for-Service payment regulations
      • National Provider Identifier Standard (NPI)
      • Advisory committees
      • Legislation
      • Promoting Interoperability Programs
      • CMS rulemaking
      • CMS Hearing Officer
      • Office of the Attorney Advisor (OAA)
      • Provider Reimbursement Review Board (PRRB)
      • Medicare Geographic Classification Review Board (MGCRB)
      • Physician Self-Referral
      • Quarterly provider updates
      • E-Prescribing
    • Coding & billing
      Back to menu

      section title h3

      • Place of service codes
      • ICD-10 codes
      • Healthcare Common Procedure Coding System (HCPCS)
      • Integrated Outpatient Code Editor
      • National Correct Coding Initiative (NCCI) edits
      • NCCI for Medicaid
      • Electronic billing
      • Medicare Administrative Contractors (MACs)
      • Provider Customer Service Program
      • Skilled Nursing Facility (SNF) consolidated billing
      • Roster billing
      • Therapy services
      • Medicare claims & public health emergencies
      • Guide for Medical Technology Companies and Other Interested Parties
    • Payment
      Back to menu

      section title h3

      • Medicare Part B Drug Average Sales Price
      • All Fee-For-Service-Providers
      • Fee schedules
      • Prospective Payment Systems
      • Opioid Treatment Programs (OTP)
      • Covid-19 Vaccine Toolkit
      • Bankruptcy
      • Sustainable Growth Rates & Conversion Factors
      • Medicare Advantage Rates & Statistics
    • Medicare-Medicaid coordination
      Back to menu

      section title h3

      • Medicare-Medicaid Coordination Office
      • Resources
      • Qualified Medicare beneficiary program
      • Spotlight
      • Events
      • Financial alignment initiative
      • Initiative to reduce avoidable hospitalizations
      • Reports & Guidance
      • Program of All-Inclusive Care for the Elderly (PACE)
      • Reporting Fraud
      • Resources for Medicare-Medicaid plans
      • Resources for state Medicaid agencies
      • Healthcare Fraud Prevention Partnership
      • Clinical Templates
    • Appeals & grievances
      Back to menu

      section title h3

      • Original Medicare appeals
      • Managed Care appeals & grievances
      • Medicare Prescription drug appeals & grievances
      • Ombudsman Center
      • Appeals Decision Search (Part C & Part D)
    • Quality
      Back to menu

      section title h3

      • Value-based programs
      • Person & Family Engagement
      • Quality improvement organizations
      • Nursing home quality improvement
      • Inpatient Rehabilitation Facility (IRF) Quality Reporting Program (QRP)
      • Home Health Quality Reporting Program
      • ESRD Quality Incentive Program
      • CMS National Quality Strategy
      • Hospice Quality Reporting Program
      • Long-Term Care Hospital (LTCH) Quality Reporting Program (QRP)
      • Appropriate Use Criteria Program
      • Quality measures
      • Clinical Laboratory Improvement Amendments (CLIA)
      • Medicare Advantage quality improvement program
      • Physician compare initiative
      • Quality initiatives
      • Part C and D Performance Data
      • Skilled Nursing Facility (SNF) Quality Reporting Program (QRP)
    • Health & safety standards
      Back to menu

      section title h3

      • Quality, safety & oversight - General information
      • Accreditation programs
      • Civil monetary penalties
      • Quality, safety & oversight - Emergency preparedness
      • State survey agencies
      • Certification & compliance
      • Enforcement
      • Quality, safety & oversight - Guidance for laws & regulations
      • Promising practices project
      • Quality, safety & oversight - Education division (QSED)
      • Conditions for coverage & participation
    • Employers & plan sponsors
      Back to menu

      section title h3

      • Creditable coverage
    • IC-Placeholder-1
    • Audits & Compliance
      Back to menu

      section title h3

      • Part A cost report audit
      • Part C/Part D compliance & audits
    • Forms & notices
      Back to menu

      section title h3

      • CMS forms
      • CMS forms list
      • Beneficiary Notices Initiative (BNI)
    • Health & drug plans
      Back to menu

      section title h3

      • Plan payment
      • Plan payment data
      • Medical loss ratio
      • Coverage Gap Discount Program
      • Managed care marketing
      • Medicare Advantage application
      • Medigap (Medicare supplement health insurance)
      • Medical Savings Account (MSA)
      • Private Fee-for-Service Plans
      • Health Care Prepayment Plans (HCPPs)
      • Cost plans
      • Special needs plans
      • Network adequacy
    • Coordination of benefits & recovery
      Back to menu

      section title h3

      • Overview
      • Mandatory Insurer Reporting for Group Health Plans (GHP)
      • Mandatory insurer reporting (NGHP)
      • Workers' comp Medicare set aside arrangements
      • Attorney services
      • Beneficiary services
      • COBA Trading Partners
      • Employer services
      • Insurer services
      • Prescription drug assistance programs
      • Provider services
    • Settlements
      Back to menu

      section title h3

      • Jimmo Settlement
      • Ryan Settlement
  • Medicaid/CHIP
    Back to main menu

    section title h2

    • What is Medicaid?
      Back to menu

      section title h3

      • Visit Medicaid.gov
      • View Medicaid maps
      • Visit CHIP.gov
    • Medicare-Medicaid Coordination
      Back to menu

      section title h3

      • Integrated care resources
      • Initiative to reduce avoidable hospitalizations
      • Financial alignment initiative
      • Medicaid Integrity Institute
    • RG-Placeholder-1
    • IC-Placeholder-2
  • Marketplace & Private Insurance
    Back to main menu

    section title h2

    • About the Marketplace
      Back to menu

      section title h3

      • Marketplace oversight
      • Affordable Care Act
      • Overview of the exchanges
      • Exchange coverage maps
      • Medicare and the Marketplace
    • Private Health Insurance
      Back to menu

      section title h3

      • Patient’s Bill of Rights
      • Medical loss ratio
      • Annual limits
      • Review of insurance rates
      • Market rating
      • Self-funded, non-federal governmental plans
      • Grandfathered plans
      • Health Reimbursement Arrangements
      • Coverage for young adults
      • Student health plans
      • Mental health parity and addiction equity
      • Prevention
      • Consumer protections & enforcement
      • Pre-existing condition insurance plan
      • Qualifying Health Coverage (QHC)
    • RG-Placeholder-2
    • In-person assisters
      Back to menu

      section title h3

      • Information for Partners
      • Assister outreach & education
      • Applications, forms, & notices
      • Assister programs & procedures
      • Assister technical resources
      • Assister training & webinars
    • Agents & Brokers
      Back to menu

      section title h3

      • Resources for Agent & Brokers
      • Registration & training
      • Open enrollment
      • Direct enrollment partners
      • General resources
      • Video Learning Center
      • Agent & Broker FAQ
      • Marketplace help desk & call centers
      • Registration Completion List
      • Marketplace Registration Tracker
      • AB Suspension & Termination List
      • Find local help
      • Issuer and direct enrollment partner directory
      • Help on demand
      • SHOP Resources
    • Health Plans & Issuers
      Back to menu

      section title h3

      • Qualified health plan certification
      • Summary of benefits & coverage
      • Insurance programs
      • Premium stabilization programs
      • Health insurance market reforms
      • Minimum essential coverage
      • Drug pricing & rebate review
    • Employers & sponsors
      Back to menu

      section title h3

      • Coverage
      • Regulation & guidance
      • Small business tax credit & premium assistance
      • Appeals
      • Small Business Health Options Program (SHOP)
      • Early retiree reinsurance program
      • Employer initiatives
    • States
      Back to menu

      section title h3

      • Planning & establishing a Marketplace
      • Territory cooperative agreements
      • Early innovator program
      • State flexibility to stabilize the Market
      • Exchange establishment grants
      • Pre-existing condition insurance plan
    • Resources
      Back to menu

      section title h3

      • About Us
      • Data resources
      • Forms, reports, & other resources
      • Letters
      • Regulations & Guidance
      • Training resources
  • Priorities
    Back to main menu

    section title h2

    • Innovation Center
      Back to menu

      section title h3

      • Overview
      • About
      • Key Concepts
      • Model Data
      • Value-Based Care Spotlight
      • Innovation Models
      • Where Innovation is Happening
      • Evaluations & Research Reports
    • Health Equity
      Back to menu

      section title h3

      • Coverage to Care
      • Minority health
      • Cobertura de atención
      • Grants & awards
    • Recent Legislation
      Back to menu

      section title h3

      • Inflation Reduction Act and Medicare
      • No Surprises Act
    • Key Initiatives
      Back to menu

      section title h3

      • Opioids
      • Flu
      • Medicare Open Enrollment
      • Medicare OE partner resources
      • Marketplace Open Enrollment
      • E-health
      • Open Payments
      • Returning to regular operations after COVID-19
      • Healthplan price transparency
      • Burden Reduction
        • About OHEI
        • Stakeholder Engagement
        • Administrative Simplification
        • Interoperability
        • Spotlight
        • Contact OHEI
      • Hospital price transparency
      • Lookup tools
    • Your Patient Rights
      Back to menu

      section title h3

      • Emergency Room Rights
      • Medical bill rights
  • Training & Education
    Back to main menu

    section title h2

    • CMS National Training Program
      Back to menu

      section title h3

      • National Training Program resources
      • Class modules
    • Partner outreach resources
      Back to menu

      section title h3

      • Partner with CMS
      • National Medicare Education Program (NMEP)
      • Low-Income Subsidy (LIS) outreach
      • Become a champion for coverage
      • Faith-Based Partners
      • Rural Health Partners
      • American Indian/Alaska Native
      • Partnering with CMS Center
    • Medicare Learning Network (MLN)
      Back to menu

      section title h3

      • Resources & training
      • Newsletter
      • Compliance
      • Partnerships
    • CMS Open Door Forums
      Back to menu

      section title h3

      • About Open Door Forums
      • Ambulance
      • End-Stage Renal Disease (ESRD) Dialysis Facility Care Compare
      • Home Health, Hospice & Durable Medical Equipment (DME)
      • Hospital
      • Long-Term Services & Supports
      • Physicians, Nurses and Allied Health Professionals
      • Rural Health
      • Skilled Nursing Facilities (SNFs)/Long-Term Care
      • Special Open Door forums
    • Look up topics
      Back to menu

      section title h3

      • Medicare
      • Medicaid
      • CHIP
      • American Indian/Alaska Native Center
      • Quality of care
      • Special populations
      • Fraud & abuse
      • States
      • Privacy
      • Health conditions & campaigns
      • New Medicare Card
      • HIPAA Administrative Simplification
    • Learn More
      Back to menu

      section title h3

      • Attend events
      • Find resources
      • Get training
      • Find tools to help you help others
      • Get digital media
    • Find your provider type
      Back to menu

      section title h3

      • Physicians & other health professionals
      • Facilities
      • Health & drug plans
      • Employers & unions
  • Medicare
  • Quality
  • Clinical Laboratory Improvement Amendments (CLIA)
  • CLIA Related Hearing Decisions and Compliance Topics

CLIA Related Hearing Decisions and Compliance Topics

      • Clinical Laboratory Improvement Amendments (CLIA)
        • How to Apply for a CLIA Certificate, Including International Laboratories
        • Accreditation Organizations & Exempt States
        • Categorization of Tests
        • Certification Boards for Laboratory Directors of High Complexity Testing
        • CLIA Brochures
        • CLIA Regulations and Federal Register Documents
        • CLIA Related Hearing Decisions and Compliance Topics
        • Cytology Proficiency Testing
        • Individualized Quality Control Plan (IQCP)
        • Interpretive Guidelines for Laboratories
        • Laboratory Demographics Lookup
        • Laboratory Registry
        • Proficiency Testing Programs
        • State Agency & CLIA Operations Branch Contacts
        • CLIA Statistical Tables/Graphs
        • CME Courses for Laboratory Directors of Moderate Complexity Laboratories
CLIA Related Hearing Decisions and Compliance Topics

The list of the CLIA-related hearing decisions, in hearing decision date order, related to the CLIA program with informational guidance for each case is found in the downloads section below.

Downloads

  • Hearing Index 2023 (PDF)
Page Last Modified:
09/10/2024 06:21 PM
Help with File Formats and Plug-Ins

Get email updates

Sign up to get the latest information about your choice of CMS topics. You can decide how often to receive updates.

CMS & HHS Websites
  • Medicare.gov
  • Medicaid.gov
  • InsureKidsNow.gov
  • HealthCare.gov
  • HHS.gov
  • HHS.gov/Open
About CMS
  • About Us
  • Careers
  • Newsroom
  • Blog
Tools
  • Acronyms
  • Archive
  • Contacts
  • Glossary
Helpful Links
  • Privacy Policy
  • Plain Language
  • Privacy Settings
  • Nondiscrimination & Accessibility
  • Developer Information
  • Vulnerability Disclosure Policy
USA Government Sites
  • Freedom of Information Act
  • No Fear Act
  • Inspector General
  • USA.gov
CMS.gov HHS Logo

Connect with CMS

  • Linkedin link
  • Youtube link
  • Facebook link
  • Twitter link
  • RSS Feed link

A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services.

7500 Security Boulevard, Baltimore, MD 21244