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The Medical Facilities Unit oversees the licensing or registration and the applicable federal certification of the following types of providers:
- Hospitals
- Nursing Homes
- Home health agencies
- Home health care services
- End stage renal disease facilities
- Intermediate care facilities for individuals with intellectual disabilities
- Ambulatory surgical centers
- Hospices
- Rural health clinics
- Portable x-ray suppliers
- Outpatient physical therapy/speech pathology
- Federally qualified health centers
- Placement agencies (non-medical agency)
- Temporary nursing agencies (non-medical agency)
- Family Provider Service Option (non-medical agency)
- Personal Care Agency (non-medical agency)
The Certification Process
The functions that the Division of Licensing & Certification (DLC) perform for the Centers for Medicare & Medicaid Services (CMS) under the agreements in Section 1864 of the Social Security Act (the Act) are referred to collectively as the certification process.
DLC conducts certification, recertification, complaint, and revisit surveys for the following provider types:
- Hospitals
- Nursing Homes
- Home health agencies
- End stage renal disease facilities
- Intermediate care facility for individuals with intellectual disabilities
- Ambulatory surgical centers
- Hospices
- Rural health clinics
- Portable x-ray suppliers
- Outpatient physical therapy/speech pathology
DLC performs only complaint surveys at Federally Qualified Health Centers.
The State Licensure Process
The functions that DLC perform under the authority of MRS 22 §1717, §1812-E, §1812-K, §2042, §2131, §2143, §2144, §2145, §2146, §2148, and §2150 are collectively referred to as the State Licensure Process.
Home Health Agencies/Home Health Care Services
Home Health Agencies/Home Health Care Services provide services to clients in their homes. These agencies must all be licensed by the State of Maine, but they have the choice of also being federally certified. Home Health Agencies are both licensed by the state and federally certified. Home Health Care Services are only licensed by the state.
Federal Regulations
- 42 CFR, Part 484, Conditions of Participation for Home Health Agencies
- State Operations Manual Appendix Q – Core Guidelines for Determining Immediate Jeopardy
State Regulations
State Statute
How to Apply for Licensure
To apply to be licensed, complete the appropriate application and submit with the required documentation and fees as detailed in the application form, and in the appropriate state regulations.
For Home Health Agencies that are State licensed and Federally certified or intend to be Federally certified:
For Home Health Agencies that are State licensed only and have no intention of being Federally certified:
Changes During the Licensing Period
Please use the following form to report changes within the licensing period. These changes may include, but not limited to, the following: agency name, physical address, mailing address, change in Program Director, addition of a branch(or branches), counties where services are being provided, email addresses, and/or telephone numbers.
For Home Health Agencies that are State licensed only and have no intention of being Federally certified:
Waiver Form:
Please use the following form to request a waiver of state regulations only.
For Home Health Agencies that are State licensed only and have no intention of being Federally certified:
Resource
End Stage Renal Disease Facilities
End Stage Renal Disease Facilities provide dialysis care to individuals in kidney failure. These facilities must all be licensed by the State of Maine and federally certified.
Federal Regulations
- 42 CFR Part 494, Conditions for Coverage for End Stage Renal Disease Facilities
- 42 CFR, §494.62, Condition for Coverage for End-Stage Renal Disease (ESRD) Facilities
- Life Safety Code
State Statute
State Regulations
How to Apply for Licensure
To apply to be licensed, complete the appropriate application and submit with the required documentation and fees as detailed in the application form, and in the appropriate state regulations.
Intermediate Care Facilities for Individuals with Intellectual Disabilities
Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) care for individuals with intellectual disabilities with a focus on active treatment services. These facilities must all be licensed by the State of Maine and federally certified.
Federal Regulations
- 42 CFR Part 483, Requirements for ICF/IIDs (PDF)
- 42 CFR, §483.475, Condition of Participation for Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) (PDF)
- Life Safety Code (PDF)
State Regulations
How to Apply for Licensure
To apply to be licensed, complete the appropriate application and submit with the required documentation and fees as detailed in the application form, and in the appropriate state regulations.
Ambulatory Surgical Centers
Ambulatory Surgical Centers provide same-day surgical care to patients. These centers must all be licensed by the State of Maine and federally certified.
Federal Regulations
- 42 CFR Part 416, Conditions of Coverage for Ambulatory Surgical Centers (PDF)
- 42 CFR, §416.54, Condition for Coverage for Ambulatory Surgical Centers (PDF)
- Life Safety Code (PDF)
State Regulations
- 10-144 CMR Chapter 125, Regulations Governing the Licensing of Ambulatory Surgical Facilities (Word)
How to Apply for Licensure
To apply to be licensed, complete the appropriate application and submit with the required documentation and fees as detailed in the application form, and in the appropriate state regulations.
Hospice Agencies
Hospice Agencies provide comfort and support to patients at end of life in their home or an approved inpatient setting. There are two types of Hospice Agencies: Hospice Agencies and Volunteer Hospice Agencies. Hospice Agencies must all be licensed by the State of Maine and federally certified. Volunteer Hospice Agencies must only be licensed by the State of Maine.
Federal Regulations
- 42 Code of Federal Regulations Part 481, Conditions of Participation for Hospice (PDF)
- 42 Code of Federal Regulations, §418.113, Condition of Participation for Hospices (PDF)
- Life Safety Code (PDF)
State Regulations
How to Apply for Licensure
To apply to be licensed, complete the appropriate application and submit with the required documentation and fees as detailed in the application form, and in the appropriate state regulations.
Application for Hospice Agencies (excludes Hospice agencies that provide Volunteer Services only)
Application and Change Notice for Volunteer Hospice Programs only:
Rural Health Clinics
Rural Health Clinics provide primary care services to patients in rural communities. These clinics must all be federally certified.
Federal Regulations
- 42 Code of Federal Regulations Part 491, Conditions for Certification: Rural Health Clinics (PDF)
- 42 CFR §491.12, Conditions for Certification for Rural Health Clinics (RHCs) and Conditions for Coverage for Federally Qualified Health Centers (FQHCs) (PDF)
To become federally certified, you must do the following:
- submit an enrollment application
- DLC will provide additional, CMS-required, forms. Complete these and return to DLC
Portable X-Ray Suppliers
Portable X-Ray Suppliers provide portable x-ray services under the supervision of a licensed medical provider who is qualified and trained in x-ray diagnostics. These suppliers must all be federally certified.
Federal Regulations
To become federally certified, you must do the following:
- submit an enrollment application
- DLC will provide additional, CMS-required, forms. Complete these and return to DLC
Outpatient Physical Therapy/Speech Pathology
Outpatient Physical Therapy/Speech Pathology (OPT/SP) providers provide, at least, outpatient physical therapy or speech language pathology services that are designed to upgrade the physical functioning of individuals. There are three types of OPT/SPs: clinics, rehabilitation agencies, and public health agencies.
Federal Regulations
- 42 Code of Federal Regulation Part 485, Conditions of Participation for Outpatient Physical Therapy or Speech Pathology Services (PDF)
- 42 CFR §485.727, Conditions of Participation for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services (PDF)
To become federally certified, you must do the following:
- submit an enrollment application
- DLC will provide additional, CMS-required, forms. Complete these and return to DLC
Federally Qualified Health Centers
Federally Qualified Health Centers are community-based health care providers that receive funds from the Health Resources and Service Administration (HRSA) Health Center Program to provide primary care services in underserved areas. These centers must all be federally certified.
Federal Regulations
- See Rural Health Clinics
To become federally certified, you must do the following:
- submit an enrollment application
- DLC will provide additional, CMS-required, forms. Complete these and return to DLC
Medical Laboratories
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities. There are four CLIA certificate types:
- Certificate of Waiver - Performs simple tests, i.e., covid-19, blood glucose, urine dipstick, urine drug screen, etc.
- Certificate of Provider Performed Microscopy - Medical providers perform exams under the microscope, i.e., urine microscopic, KOH Prep, etc. They can perform waived testing with the PPM certificate
- Certificate of Compliance - Moderate to High complexity laboratory testing. These laboratories are surveyed by individual State surveyors
- Certificate of Accreditation - Moderate to High complexity testing. These laboratories are surveyed by CLIA- approved accrediting agencies (College of American Pathologists, Joint Commission, etc.)
Maine's State Laboratory Rules and Regulations (PDF)
Applications and Resources:
- Medical Laboratory License Application (PDF)
- Health Screening Laboratory Application (PDF)
- CMS116 new 2022 (PDF)
How to Become Federally Certified
To become federally certified, you must do the following:
- submit an enrollment application
- DLC will provide additional, CMS-required, forms. Complete these and return to DLC
How to Apply for Licensure
To apply to be licensed, complete the appropriate application and submit with the required documentation and fees as detailed in the application form, and in the appropriate state regulations.
- Home Health Initial & Renewal Application (PDF)
- End-Stage Renal Disease Initial & Renewal Application (PDF)
- ICF/IID Initial & Renewal Application (PDF)
- Ambulatory Surgical Center Initial &Renewal Application (PDF)
- Hospice Initial & Renewal Application (PDF)
Changes to a Provider After Initial Licensure
The provider must report the following changes to DLC:
- Change of ownership
- Change of administrator/person in charge
- Change of scope/nature of services provided
- Relocation
- Change of mailing address
- Change of phone/fax number or email address
- Deeming status
These changes require a change in licensure or registration and must be reported to DLC with the applicable fee as outlined in MRS 22 §1723.
If the provider is federally certified, the applicable CMS-required form must be completed, as required by CMS, and submitted to the fiscal intermediary.
- CMS Policies and Memos to States and Regions - includes survey and certification memoranda, guidance, clarifications and instructions to state survey agencies.
- CMS General Information