Independent Laboratory Enrollment Criteria and Forms

Posted: May 24, 2023

The facility must be certified under the Clinical Laboratory Improvement Amendments (CLIA) to enroll as an independent laboratory with Minnesota Health Care Programs (MHCP) and pay a screening fee to MHCP, Medicare, or send proof that the fee was paid to another State Medicaid Authority.

How to Enroll

Independent laboratories who wish to enroll with MHCP or make enrollment requests can do so in one of the following two ways:

Register to access the Minnesota Provider Screening and Enrollment (MPSE) portal and complete your enrollment online using the MPSE portal. Also, upload the following in the MPSE Portal:

· Provider Agreement (DHS-4138) (PDF)

· A copy of the facility’s CLIA Certificate

· Confirmation of fee payment to MHCP, another state, or Medicare

or

Complete the following documents required to enroll as an independent laboratory and fax your materials to MHCP Provider Eligibility and Compliance at 651-431-7462.

· Organization – Provider Enrollment Application (DHS-4016A) (PDF)

· Provider Agreement (DHS-4138) (PDF)

· Disclosure of Ownership and Control Interest (DHS-5259) (PDF)

· EFT Vendor Number Notification (DHS-3725) (PDF) (optional)

· A copy of the facility’s CLIA Certificate

· Confirmation of fee payment to MHCP, another state, or Medicare

Review and keep a copy of the MHCP Data Privacy Notice (DHS-6287) (PDF).

We process forms in order of date received. Allow 30 days for processing whether enrolling using the MPSE portal or by fax. If we need more information to complete your enrollment, we will send a request for more information letter via U.S. mail (or via your MN–ITS mailbox, if you have an account) telling you what we need or what you need to do to complete your enrollment.

Revalidation

MHCP is required to follow the Centers for Medicare & Medicaid Services (CMS) final federal provider screening regulations.

Refer to Revalidation in the Provider Screening Requirements section of the MHCP Provider Manual for more information about how to complete your revalidation.

Reporting Changes

Report any changes made on a record to MHCP Provider Eligibility and Compliance. Refer to Changes to Enrollment in the Enroll with MHCP section of the MHCP Provider Manual for details.

Changes in ownership should be reported 30 days in advance, and require new copies of all enrollment documents, along with a signed copy of the Provider Entity Sale or Transfer Addendum (DHS-5550) (PDF).

Additional Resources

Minnesota Statutes, 144.12, subdivision 1 (Regulation, Enforcement, Licenses, Fees; Rules)
Minnesota Statutes, 256B.02, subdivision 7 (Definitions; Vendor of medical care)
Minnesota Statutes, 256B.0625 (Covered Services)
Minnesota Rules, 9505.0305 (Laboratory and X-ray Services)
Code of Federal Regulations, title 42, section 440.130 (Diagnostic, screening, preventive, and rehabilitative services)