Medicare Certification

After the center meets the state licensure requirements, it must meet the CMS Conditions for Coverage. The state Operations Manual published by CMS can be found on the Federal Register, 42 CFR 416, and contains the parameters that must be met in order to apply for Medicare Certification. Once the state licensure Law has been determined, the next condition that must be met is to assure that the ASC is a distinct entity that operates exclusively to furnish outpatient surgical services. It can be either an independent freestanding facility, or under the common ownership, licensure or control of a hospital. With many specialties, it may be more advantageous for efficiency, for the physician’s practice to be in the same environment as the ASC. This would require that it be separated from the ASC by at least semi-permanent walls. State Interpretation of this regulation varies. Some states will allow some shared spaces but would require that the two entities not run concurrently and that the staff is exclusive to the ASC.

Specific Conditions for Coverage for CMS include:

Governing Body and Management: Assumes full legal responsibility for total
operations

Surgical Services: Physicians must be fully credentialed and approved by the
Governing Board

Evaluation of Quality: Ongoing Continuous Quality Improvement & Risk
Management programs, Peer Review, Chart Review, Credentialing with
primary verification source

Safety: Many states require a separate Safety Plan with Officer and
incidence reporting

Medical Staff: legally and professionally qualified for appointment

Nursing Services: RN trained in CPR must be available whenever a patient is
the ASC (ACLS – Recovery Room)

Medical Records: Complete, comprehensive and accurate

Pharmaceutical Services: DEA license to dispense narcotics

Laboratory: Must have a contract with a Medicare certified laboratory/pathology and also a CLIA waiver to perform limited tests

Radiological Services: must be contracted with a medicare certified radiology department (even though some specialties would never need this, it is a requirement of medicare certification)

Physical Environment

All ASC’s must meet requirements of the Federal and State Fire Safety Codes: Safe,
sanitary and appropriate environment for an ASC. It is crucial to determine the
individual state regulations prior to any construction, as the source and year version of
the requirements holds different requirements. Codes used by the individual states can be from the Centers for Medicare and Medicaid Services (CMS, formerly, HCFA), the
National Fire Protection Association and/or from the American Institute of Architects.

Some States have their own individual building code as well. These codes include
specifics on construction type, engineering, electrical, mechanical as well as storage and monitoring and alarm systems. Parameters include regulations on:

  • Fire resistance/sprinklers
  • Functional Zoning
  • Public/Administrative
  • Prep Area
  • Procedure Suites
  • Recovery Suite
  • Staff “amenities”
  • ADA compliant
  • Specific Rooms and Functions
  • Minimum Areas and/or Dimensions

Minimal Emergency Equipment

  • Oxygen
  • Mechanical ventilatory equipment
  • Defibrillator and cardiac monitoring
  • Tracheostomy set
  • Laryngoscopes and endotracheal tubes
  • Suction
  • Break away lock on crash cart
  • MHA cart as applicable

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