Licensing and Certification
Freestanding Outpatient Surgical Center

1. Submit the Application for a License to Operate a Freestanding Outpatient Surgical Center (PDF) and supporting documents to Minnesota Department of Health (MDH). 
2. After MDH receives the application and payment, MDH will assign a Health Facility Identification (HFID) number and notify the facility (not applicable for a relocation). 
3. Submit a Construction Plan Submittal Package to the Engineering Services – Construction Plan Submittal Process for Healthcare Facilities. 
4. MDH Engineers and State Fire Marshals will coordinate with the facility to schedule inspections. 
5. Once all inspections and the licensing survey are cleared and recommended for licensure, MDH will issue the Freestanding Outpatient Surgical Center license. 
6. Surgeries may not be scheduled until MDH issues the license.

To become Medicare certified, a surgical center must be licensed as a Minnesota Freestanding Outpatient Surgical Center. 

For an initial certification, submit the following: 

• CMS-855B, Medicare Enrollment Application-Clinics/Group Practicers and Certain Other Supplies, to the Medicare Administrator Contractor (MAC). 
• CMS-370, Health Insurance Benefits Agreement-Ambulatory Surgical Center 
• CMS-377, Ambulatory Surgical Center Request for Certification in Medicare 
• Notify MDH of the approved Accrediting Organization (AO) that will conduct the initial survey. 

MDH will process the initial certification survey documents and required federal forms and submit the recommendation to the MAC. If approved, CMS will issue an approval letter that includes the CMS Certification Number (CCN) and the effective date of the initial certification. If not approved, CMS will issue a denial letter. 

For a relocation certification, submit the following: 

• CMS-855B, Medicare Enrollment Application-Clinics/Group Practicers and Certain Other Supplies, to the Medicare Administrator Contractor (MAC). 
• CMS-377, Ambulatory Surgical Center Request for Certification in Medicare 

Note: The CCN will transfer administratively to the new location.

An applicant may qualify for a conditional outpatient surgical center license if the proposed center will operate in a facility shared with an existing licensed outpatient surgical center that is already Medicare-certified as an Ambulatory Surgical Center (ASC).

How to Apply

• Submit a licensure application and all required documents and fees.  
• Provide proof of eligibility, including documentation that:  
  • The proposed center will share a facility with an existing licensed outpatient surgical center.
  • The existing center is Medicare-certified as an ASC.
  • Receive a conditional license, if approved.  
  • Valid for up to 120 days.
  • May be renewed once for an additional 120 days.
  • Obtain Medicare ASC certification during the conditional licensure period.  
  • Submit proof of certification to request conversion to a nonconditional license.  
  • Receive a nonconditional license after certification is verified. 

Complete the following for the license portion:

1. Submit the Application for a License to Operate a Freestanding Outpatient Surgical Center (PDF) and supporting documents to Minnesota Department of Health (MDH).
2. Proposed documentation that substantiates a CHOW (e.g., bill of sale, mergers, etc.) Once sale occurs, submit executed documents.
3. Organizational charts (pre-CHOW and post-CHOW) showing lines of authority.

Complete the following the Medicare certification portion:

1. Submit to MDH
   • CMS-370, Health Insurance Benefits Agreement-Ambulatory Surgical Center
   • CMS-377, Ambulatory Surgical Center Request for Certification in Medicare
2. If the purchaser (or lessee) elects not to accept a transfer of the provider agreement, then the old agreement should be terminated, and the purchaser or lessee is considered a new applicant and must initially enroll in Medicare. 
3. Submit CMS-855B, Medicare Enrollment Application-Clinics/Group Practicers and Certain Other Supplies, to the Medicare Administrator Contractor (MAC) (if applicable).
4. If deemed status, notify the accrediting organization (if applicable).

The Minnesota Department of Health (MDH) will review all submitted documentation and provide a recommendation to the Medicare Administrative Contractor (MAC) to approve or deny the CHOW. The Centers for Medicare & Medicaid Services (CMS) retains final authority and will issue a written notification of the decision to the new owner.

Freestanding Outpatient Surgical Center licenses are renewed annually. Licensees will receive a renewal notification approximately 60-90 days prior to the expiration date of the license. If you do not receive a renewal notification within 30 days of the expiration date, please contact Health.HRD-FEDLCR@state.mn.us.

1. Submit the Application for a License to Operate a Freestanding Outpatient Surgical Center (PDF) and supporting documents to Minnesota Department of Health (MDH).
2. Submit a current accreditation letter or other documentation verifying accreditation status.
3. Pay the required nonrefundable fee.

A surgical center that has a remodeling project (e.g., adding a surgical suite, remodeling waiting area, etc.) should do the following: 

1. Submit a Construction Plan Submittal Package to the Engineering Services – Construction Plan Submittal Process for Healthcare Facilities. 
2. MDH Engineers and State Fire Marshals (if applicable) will coordinate with the facility to schedule inspections. 
3. A health licensing walk through may also be required. 
4. Once all inspections are cleared and recommended for occupancy, MDH will issue a letter authorizing occupancy.

• State Operations Manual, Chapter 2-The Certification Process  
• Medicare State Operations Manual, Appendix L – Guidance for Surveyors: Ambulatory Surgical Centers 
• CMS Policy & Memos to States and Regions — CMS issues S&C memos on a weekly basis.  Providers are responsible for checking the CMS S&C memo website each week for new information.  
• Quality Assurance for the Medicare and Medicaid Program Mission and Priority Document (MPD). CMS Mission & Priority Information — MPD is a document that directs and prioritizes QSOG’s, the Survey and Operations Group’s (SOG), and the SA’s workload.  CMS updates it each year to reflect regulatory changes, adjustments in budget allocations, new initiatives, new statutory requirements, survey and certification functions, work priorities and planning recommendations to support Sas and funding allocation. 

• Accreditation Status Change (PDF) 
• Change of Administrator (PDF)
• Closure (PDF)
• Doing Business As (DBA) Name Change (PDF)
• Legal Entity Name Change (PDF)
• Example Form: Certificate of Liability Insurance (PDF) 
  Providers are required to submit evidence of workers’ compensation coverage with their application; this example shows how the form should be filled out.

• Minnesota Statutes 144.651 - Health Care Bill of Rights 
• Minnesota Statutes 144.652 - Bill of Rights Notice to Patients or Resident; Violation 
• Minnesota Statutes 626.557 - Reporting of Maltreatment of Vulnerable Adults 
• Minnesota Statutes 144.122 - License, Permit and Survey Fees 
• Minnesota Statutes 144.55 - Licenses; Issuance, Suspension and Revocation

• Minnesota Rules, Chapter 4675 - Outpatient Surgical Centers