Licensure/Certification & Accreditation
Feasibility for Starting for an ASC
- Type of facility and services provided
- Geographical market research and area competition
- Procedure types and volumes performed
- Payer mix: determine rates of facility fees from Managed Care,
- Commercial and Workers Compensation
- CON/Licensing/Surveys and Permits as applicable
- Architectural/Construction/Electrical/Mechanical
- Equipment and supplies: Medical and Administrative
- Contracted services
- Legal/Accounting
- Staffing
- Rent or mortgage
- Interest and principal payments (Cash flow, first three-six months)
Itemized Task List
Realizing that an ASC is one the most highly regulated Health Care Entities with many
regulations to meet, it is most efficient to create a detailed task list and develop a team to work together toward your goal. Assignment of tasks should include:
- Research and determination of individual State requirements CON filing or exemption?
- Legal issues- stark, anti kick-back?
- Design and construction plans
- Name of Facility/Tax ID number
- Articles of Incorporation or operating agreement
- Shareholders agreement
- Determine Governing Body and
- Organizational Chart
- By-Laws
- Medical Staff Rules and Regulations
- Loan and Line of Credit
- Billing Service or in-house
- Staff Recruitment
- Proposals on equipment and supplies
- State License application, Medicare applications and AAAHC applications filed minimum of 90 days prior to construction finish out
- Begin requesting all other payor applications
Phase 2 Tasks
- Develop detailed policies and procedures to comply with Medicare Conditions for Coverage and
- State Provisions for Licensure (Note: many State Departments of Health publish their provisions
- for ASC Licensure on their website).
- Perform Credentialing with primary verification source for all Clinical Staff through The National Practitioners Data Bank and the American Medical Association.
- Stocking and Storage of equipment and supplies is next, all equipment must be inspected, tagged and an in-service documented.
Certificate of Need
Some states require a Certificate of Need (commonly referred to as CON, Certificate of
Public Need (COPN) or Determination of Need (DON) but certainly not all, or even a
majority to establish a new ASC. CON is state regulatory program intended to balance
cost, quality, and access issues and ensure that only needed services and facilities are
developed as needed. It may be possible to obtain an exemption in some states for single specialty ASC's or for just one operating room or for wholly physician owned ASC's. The process of CON or an exemption varies per state such as:
- A petition may be filed in some states for exemption
- Some states have a number of rooms exemption - such as one operating room facilities
- Some states have a cost of the project threshold for exemption
State License
To participate in the Federal ASC program and receive facility fees from governmental
payers, the ASC must meet Medicare criteria and approval, known as Certification. This
Certification is also mandatory in order to contract with "other" payers for facility fees.
A pre-requisite to Medicare Certification is compliance with State Licensure Law.
Although Medicare governs the ASC program, each state Department of Health is their
own authority having jurisdiction over the program. Forty-three states require a state licensure for ASC's. These states specify the criteria that ASC's must meet for licensure prior to Certification.
The process of Licensure includes surveys and approval by the state department of health. In return for making increased payments to ASCs, federal and state governments have specific requirements for the physical environment as well as a whole host of rules and regulations covering procedures performed, staffing and administrative function.
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
Accreditation
Many surgery centers choose to go through a voluntary accreditation processes conducted by their peers. This accreditation is sometimes referred to as a "third party survey" and may be mandatory in some states or with some payers. ASC's can seek accreditation from one of three accrediting bodies: Accreditation Association for Ambulatory Health Care, Inc (AAAHC), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), or The American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF).
All accredited ASCs must meet specific standards that are evaluated during on-site
inspections. These accrediting bodies also have deemed status by CMS to survey for
Medicare Certification. Typically this survey is after the facility has been open for 6
months; however, an early option is available to satisfy state and/or payer requirements.
Proof of state License or exemption letter will be needed before they will schedule the
survey. Medicare Certification survey through an Accrediting Body is unannounced.
Accrediting bodies will typically give a 1-3 month window for survey.
