DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICESForm Approved OMB No. 09380581CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION ALL APPLICABLE.
Open form follow the instructions
Easily sign the form with your finger
Send filled & signed form or save
How to fill out the CMS-116 online
The CMS-116 form is essential for laboratories seeking certification under the Clinical Laboratory Improvement Amendments (CLIA). This guide provides step-by-step instructions to ensure users can easily and accurately complete the form online.
Follow the steps to successfully complete the CMS-116 form.
- Press the ‘Get Form’ button to access the CMS-116 form and open it in your preferred online editor.
- Begin with Section I: General Information. Fill out your laboratory's name, CLIA identification number (leave blank if you're a first-time applicant), and contact details, including email and phone number.
- Select the appropriate certificate type in Section II. Choose from Certificate of Waiver, Certificate for Provider Performed Microscopy (PPM), Certificate of Compliance, or Certificate of Accreditation.
- In Section III, choose the type of laboratory that best describes your facility from the provided options.
- Fill in Section IV with the hours during which testing is performed, using HH:MM format. If testing is available 24/7, check the applicable box.
- If applicable, complete Section V regarding multiple sites. Indicate whether you are applying for a single site CLIA certificate to cover multiple testing locations.
- Complete Section VI for waived testing if applying for a Certificate of Waiver. List the waived tests along with their estimated annual test volume.
- If applying for a Certificate for PPM, fill in Section VII with the PPM tests performed and their estimated volumes.
- Complete Section VIII for non-waived testing if applying for a Certificate of Compliance or Accreditation. Provide detailed information about tests performed and estimated test volume.
- In Section IX, describe the type of ownership of your laboratory.
- If the laboratory director oversees other certified laboratories, list them in Section X.
- After completing all applicable sections, review the information for accuracy. Save your changes, and if necessary, download or print the completed form.
Complete your CMS-116 application online today and ensure your laboratory meets all necessary certification requirements.
Experience a faster way to fill out and sign forms on the web. Access the most extensive library of templates available.
Related content
The CLIA application (Form CMS-116) collects information about your laboratory's operation...
Mar 19, 2024 — ... CMS-116 applications, demographic updates, certificate status or...
CMS - Center for Medicare and Medicaid Services. COL. - Column. CORF ... Line 116--Are you...
Get answers to your most pressing questions about US Legal Forms API.
What is the CMS sequestration for 2024?
Beginning in January 2024, CMS' RDS Center will implement an update to the sequestration policy, whereby the mandatory two percent (2%) payment reduction will be applied at each interim payment request rather than applying the reduction only to the final payment.
What is the fixed-loss outlier threshold for 2024?
The FY 2024 fixed-loss threshold for high-cost outlier cases is $59,873, which is lower than the $94,378 proposed amount but still greater when compared to the $38,518 in FY 2023.
What is the fixed-loss threshold?
To qualify for outlier payments, a case must have costs above a fixed-loss threshold amount (a dollar amount by which the costs of a case must exceed payments in order to qualify for outliers).
What is the CMS 116 form and its purpose?
The CLIA application (Form CMS-116) collects information about your laboratory's operation which is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. This information will also provide an overview of your facility's laboratory operation.
What are CMS inpatient billing codes?
Starting in CY 2023, hospital inpatient and observation care by practitioners will be billed using the same CPT codes, CPT codes 99221 through 99223, 99231 through 99233, and 99238 and 99239. (CPT 99234 through 99236 are already used for billing hospital inpatient or observation care (including admission or discharge.)
What is the CMS fixed loss threshold?
However, it also finalized a fixed-loss threshold for high-cost outlier cases of $59,873 in FY 2024, as compared to $38,518 in FY 2023; while this final number is lower than the $94,378 the agency proposed, it will still reduce overall net standard payments to LTCHs by 2.9%.
What does it mean to be CLIA certified?
In simple terms, being CLIA certified and CAP accredited ensures your test results are meeting and exceeding industry standards for clinical laboratory testing.
What is the CMS 2024 proposed rule?
On April 4, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that revises the Medicare Advantage Program, Medicare Prescription Drug Benefit Program (Medicare Part D), Medicare Cost Plan Program, Programs of All-Inclusive Care for the Elderly (PACE), and Health Information Technology ...
Use professional pre-built templates to fill in and sign documents online faster. Get access to thousands of forms.
If you believe that this page should be taken down, please follow our DMCA take down process here.