State filing guide
CLIA waiver application and requirements in New York.
Ask about my application — no payment todayNew York has two routes: qualifying own-patient physician offices use federal POLEP; other eligible waived-only facilities use CLEP Limited Service Laboratory registration.
Sources checked 2026-10-31 · next source check due 2026-11-30
Facility or practice conditions
These findings describe the linked sources. They do not establish that your facility qualifies for an exemption or that its application is ready. Facility type, ownership, personnel, locations and exact test systems can change the requirements.
Get the New York CLIA waiver checklist by email
The federal CMS-116 steps, what New York's official sources say, what to confirm for your facility, and the official links, in one email you can keep. Free.
What the official sources say
- CMS lists New York as CLIA-exempt, but NYS POLEP expressly administers federal CLIA for qualifying professionally owned and operated practices testing their own patients through their providers or employees.
- POLEP requires CMS-116, DOH-5793 ownership disclosure, an IRS-issued facility name/EIN letter (commonly called SS-4 verification), the director's New York license (current, if applicable), and a management contract or no-contract statement; DOH-5793 also specifies a signed membership-change notification letter for LLC/LLP applicants.
- POLEP initial instructions accept only physician offices that are proprietary/for-profit and do not apply the CMS-116 multi-site exemption to New York POLs. DOH-5793 prefers email to clia@health.ny.gov for the ownership statement; confirm the complete initial packet channel.
- For a confirmed federal POLEP waiver route, CMS lists $248 per two-year certificate and electronic coupons/certificates with Pay.gov. The reviewed POLEP materials do not establish a separate state surcharge or initial-application processing time.
- Other eligible direct-care facilities performing only waived and/or PPM procedures register through CLEP using DOH-4081 (6/25). The initial application is mail-only, with original signatures and a $200 non-refundable fee; CLEP asks for at least three weeks from receipt and issues a two-year certificate limited to listed tests.
- Regulations adopted September 2, 2026 permit waived testing at collecting stations under a valid Limited Service Laboratory registration; the specific site and registration conditions still require confirmation.
Fees and timing
Route first: confirmed federal POLEP waiver $248 biennially via the CMS paperless/Pay.gov process; any POLEP state surcharge remains unverified. CLEP LSL initial/reapplication $200 non-refundable with state materials, not a separate federal waiver filing. No agency approval date is promised.
Check my test menuWhat still needs confirmation for your facility
- 1Confirm professional ownership/control, entity membership, management, operators, employees, own-patient relationships, exact tests and site model before selecting POLEP or CLEP.
- 2For a POLEP candidate, confirm the full initial-packet submission channel, signature requirements, any additional state charges and current processing expectations; the published ownership-statement email instruction does not settle every packet detail.
Frequently asked questions
What filing route does the cited New York guidance describe?
New York has two routes: qualifying own-patient physician offices use federal POLEP; other eligible waived-only facilities use CLEP Limited Service Laboratory registration.
Which requirements are named in the cited New York materials?
CMS lists New York as CLIA-exempt, but NYS POLEP expressly administers federal CLIA for qualifying professionally owned and operated practices testing their own patients through their providers or employees. POLEP requires CMS-116, DOH-5793 ownership disclosure, an IRS-issued facility name/EIN letter (commonly called SS-4 verification), the director's New York license (current, if applicable), and a management contract or no-contract statement; DOH-5793 also specifies a signed membership-change notification letter for LLC/LLP applicants. POLEP initial instructions accept only physician offices that are proprietary/for-profit and do not apply the CMS-116 multi-site exemption to New York POLs. DOH-5793 prefers email to clia@health.ny.gov for the ownership statement; confirm the complete initial packet channel. For a confirmed federal POLEP waiver route, CMS lists $248 per two-year certificate and electronic coupons/certificates with Pay.gov. The reviewed POLEP materials do not establish a separate state surcharge or initial-application processing time. Other eligible direct-care facilities performing only waived and/or PPM procedures register through CLEP using DOH-4081 (6/25). The initial application is mail-only, with original signatures and a $200 non-refundable fee; CLEP asks for at least three weeks from receipt and issues a two-year certificate limited to listed tests. Regulations adopted September 2, 2026 permit waived testing at collecting stations under a valid Limited Service Laboratory registration; the specific site and registration conditions still require confirmation.
What do the sources establish about fees and timing in New York?
Route first: confirmed federal POLEP waiver $248 biennially via the CMS paperless/Pay.gov process; any POLEP state surcharge remains unverified. CLEP LSL initial/reapplication $200 non-refundable with state materials, not a separate federal waiver filing. No agency approval date is promised.
Does this page confirm CLIA approval or legal compliance in New York?
No. This is an educational prep checklist. It does not confirm approval, legal compliance, or waived status for any specific device. Verify every requirement with CMS, the FDA, and your state agency before testing.
Other jurisdictions
Each jurisdiction publishes its own terminology, forms, channel, signatures, and fees.
All 52jurisdictions →Official sources behind this guide
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