Ambulatory Surgical Services

Basis and scope.

This section outlines the statutory basis and scope for Medicare coverage and payment of facility services in ambulatory surgical centers.

Basis for payment.

The basis for payment depends on where the services are furnished.

Applicability.

This provision specifies that the subpart applies to facility services furnished before January 1, 2008.

ASC facility services payment rate.

This section defines the methodology for determining prospectively set payment rates for ambulatory surgical center facility services.

Publication of revised payment methodologies.

CMS is required to publish notices in the Federal Register when proposing or establishing revisions to ambulatory surgical center payment rates.

Surveys.

ASCs must maintain financial records and submit operational data upon request for CMS to analyze and reevaluate payment rates.

Basis and scope.

This section details the statutory basis and scope for the revised payment system for surgical services in ambulatory surgical centers.

Applicability of this subpart.

The provisions of this subpart apply to ASC services furnished on or after January 1, 2008.

General rules.

This section establishes general rules for payment of ASC services, physician services, and other items in connection with covered surgical procedures.

Scope of ASC services.

This section defines the scope of included facility services, covered ancillary services, and excluded services for ASC payment purposes.

Covered surgical procedures.

This provision defines the criteria and safety standards for surgical procedures covered under the Medicare Ambulatory Surgical Center (ASC) payment system.

Basis of payment.

This provision establishes the unit of payment and the methodology for classifying ASC services into Ambulatory Payment Classification (APC) groups for Medicare reimbursement.

Determination of payment rates for ASC services.

This provision details the standard methodology, conversion factors, and adjustments used to calculate national unadjusted payment rates for ASC services.

Adjustments to national payment rates.

This provision establishes the methodology for adjusting Medicare payment rates for ambulatory surgical center services, including geographic adjustments, multiple procedure discounting, and interrupted procedure policies.

Publication of revised payment methodologies and payment rates.

CMS annually publishes updated payment methodologies, rates, and lists of covered surgical procedures and ancillary services for ambulatory surgical centers.

Payment for non-opioid pain management drugs, biologicals, and medical devices.

This provision defines eligibility and payment amounts for separate reimbursement of non-opioid pain management drugs, biologicals, and medical devices in ambulatory surgical centers.

Limitations on administrative and judicial review.

This provision specifies that certain ASC payment-related determinations, such as classification systems and relative weights, are not subject to administrative or judicial review.

Payment and coinsurance reduction for devices replaced without cost or when full or partial credit is received.

CMS mandates reductions in ASC payments and beneficiary coinsurance when implanted devices are replaced without cost or when the facility receives credit for the device.

Basis and scope.

This provision outlines the legal basis and scope for payment adjustments for new technology intraocular lenses furnished at ambulatory surgical centers.

Process for establishing a new class of new technology IOLs.

This provision details the annual process for CMS to announce deadlines, solicit public comments, and make determinations regarding new classes of new technology intraocular lenses.

Request for review of payment amount.

This provision specifies the requirements, eligibility, and content for submitting a request to CMS for review of the payment amount for new technology intraocular lenses.

Determination of membership in new classes of new technology IOLs.

CMS establishes criteria for determining whether an intraocular lens (IOL) qualifies for a payment adjustment as a new technology IOL when inserted at an ambulatory surgical center.

Definitions.

This section defines key terms used in the regulation of ambulatory surgical centers, including ASC services, covered surgical procedures, and facility services.

Payment adjustment.

This section outlines the process for ASCs to receive payment adjustments for new technology intraocular lenses, including billing requirements and duration of adjustments.

Basic requirements.

This section establishes the fundamental requirements for a facility to participate as an ambulatory surgical center, including meeting definitions and maintaining a CMS agreement.

Qualifying for an agreement.

This section outlines the process for ASCs to qualify for a Medicare agreement, including deemed status through accreditation, survey requirements, and appeal rights.

Terms of agreement with CMS.

As part of the agreement under § 416.26 the ASC must agree to the following:

Basis and scope of subpart.

This section establishes the statutory basis and scope for the Ambulatory Surgical Center Quality Reporting (ASCQR) Program, including payment update reductions for non-reporting.

Participation and withdrawal requirements under the ASCQR Program.

This section details the rules for participation, withdrawal, and minimum case volume requirements for the ASCQR Program, including exceptions for certain facilities.

Data collection and submission requirements under the ASCQR Program.

This section specifies the data collection, submission mechanisms, deadlines, and extraordinary circumstance exceptions for the ASCQR Program, including claims-based and web-based measures.

Public reporting of data under the ASCQR Program.

CMS publicly reports data submitted by Ambulatory Surgical Centers for the ASCQR Program after providing the facility an opportunity to review the data.

Retention and removal of quality measures under the ASCQR Program.

CMS establishes criteria and processes for retaining, suspending, or removing quality measures from the ASCQR Program based on safety, clinical relevance, and performance factors.

Measure maintenance under the ASCQR Program.

CMS outlines the procedures for updating measure specifications, distinguishing between substantive and non-substantive changes for the ASCQR Program.

Reconsiderations under the ASCQR Program.

Ambulatory Surgical Centers may request reconsideration of CMS decisions regarding ASCQR Program compliance and payment determinations through a formal submission process.

Termination of agreement.

This provision outlines the procedures for voluntary and involuntary termination of an ASC's Medicare participation agreement, including notice requirements and reinstatement conditions.

Condition for coverage—Compliance with State licensure law.

Ambulatory Surgical Centers are required to maintain compliance with all applicable State licensure requirements as a condition for Medicare coverage.

Condition for coverage—Governing body and management.

The ASC must have a governing body that assumes legal responsibility for operations, quality oversight, disaster preparedness, and emergency transfer procedures.

Condition for coverage—Surgical services.

Surgical procedures must be performed by qualified physicians with clinical privileges, and anesthesia services must be administered by qualified personnel with appropriate risk evaluation.

Conditions for coverage—Quality assessment and performance improvement.

The ASC must maintain a data-driven QAPI program that monitors patient outcomes, safety, and infection control, with oversight from the governing body.

Condition for coverage—Environment.

The ASC must maintain a safe, sanitary, and properly equipped environment that meets life safety and building code requirements to protect patient health.

Condition for coverage—Medical staff.

The medical staff of the ASC must be accountable to the governing body and maintain established processes for clinical privileges and practitioner oversight.

Condition for coverage—Nursing services.

The ASC must ensure nursing services are directed and staffed to meet patient needs, including the availability of a registered nurse for emergencies.

Condition for coverage—Medical records.

The ASC must maintain complete, accurate, and legible medical records for each patient, including specific documentation requirements for surgical procedures.

Condition for coverage—Pharmaceutical services.

The ASC must provide drugs and biologicals safely under the direction of a designated individual, following established standards for administration and documentation.

Condition for coverage—Laboratory and radiologic services.

The ASC must ensure that laboratory and radiologic services are provided in accordance with applicable certification and quality standards.

Condition for coverage—Patient rights.

The ASC must inform patients of their rights, protect those rights, and maintain processes for grievances, advance directives, and privacy.

Conditions for coverage—Infection control.

The ASC must maintain an ongoing infection control program designed to prevent, control, and investigate infections and communicable diseases.

Conditions for coverage—Patient admission, assessment and discharge.

Ambulatory Surgical Centers must ensure patients receive appropriate pre-surgical and post-surgical assessments and that all discharge requirements are met.

Condition for coverage—Emergency preparedness.

Ambulatory Surgical Centers must establish and maintain an emergency preparedness program that includes a risk assessment, policies, communication plan, and training.

General rules.

This provision defines the scope of facility services payable under Medicare for surgical procedures performed in participating facilities.

Scope of facility services.

This provision outlines the specific items and services included in and excluded from facility services for Medicare payment purposes.

Covered surgical procedures.

Effective for services furnished before January 1, 2008, covered surgical procedures are those procedures that meet the standards described in paragraphs (a) and (b) of this section and are included in the list published in accordance wi...

Performance of listed surgical procedures on an inpatient hospital basis.

The inclusion of a procedure as a covered surgical procedure for ASCs does not preclude its coverage in an inpatient hospital setting.

Applicability.

This provision specifies that the subpart applies to facility services furnished before January 1, 2008.