Medical Facilities

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 facility 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
  • Temporary nursing agencies

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 MRSA 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 Healthcare Services

Home Health Agencies/Home Healthcare 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 being federally certified. Home Health Agencies are both licensed by the state and federally certified. Home Healthcare Services are only licensed by the state. Home Health services include, but are not limited to:

Federal Regulations

State Regulations

For Home Health Agencies Only: State Operations Manual Appendix Q – Core Guidelines for Determining Immediate Jeopardy

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

State Regulations

State Operations Manual Appendix Q – Core Guidelines for Determining Immediate Jeopardy

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

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

State Regulations

State Operations Manual Appendix Q

Core Guidelines for Determining Immediate Jeopardy (PDF)

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

State Regulations

For Hospice Agencies only: State Operations Manual Appendix QCore Guidelines for Determining Immediate Jeopardy

Rural Health Clinics

Rural Health Clinics provide primary care services to patients in rural communities. These clinics must all be federally certified.

Federal Regulations

State Operations Manual Appendix QCore Guidelines for Determining Immediate Jeopardy (PDF)

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 - 42 Code of Federal Regulations, Part 486, Subpart C - Conditions for Coverage: Portable X-Ray Services (PDF)

State Operations Manual Appendix Q Core Guidelines for Determining Immediate Jeopardy (PDF)

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

State Operations Manual Appendix QCore Guidelines for Determining Immediate Jeopardy (PDF)

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

State Operations Manual Appendix QCore Guidelines for Determining Immediate Jeopardy (PDF)

Placement Agencies

Placement Agencies are any person or entity engaged for gain or profit in the business of securing or attempting to secure home care services work for an individual. A Placement Agency includes, but is not limited to:

  • employment agencies
  • nurse registries
  • any other entity that places a home care services worker for hire by a consumer in that consumer's residence for purposes of providing home care services.

DLC registers these agencies only.

Temporary Nurse Agencies

A Temporary Nurse Agencies is a business entity or subdivision thereof that provides nurses to another organization on a temporary basis within the State of Maine.

DLC registers these agencies only.

Clinical Laboratory Improvement Amendments

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., 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.)

Federal Regulations

How to Become Federally Certified

To become federally certified, you must do the following:

  1. submit an enrollment application
  2. DLC will provide additional, CMS-required, forms. Complete these and return to DLC

How to Apply for Licensure or Registration

To apply to be licensed or registered, complete the appropriate application and submit with the required documentation and fees as detailed in the application form, and in the appropriate state regulations.

Changes to a Provider After Initial Licensure or Registration

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 MRSA 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.