§ 416.164 Scope of ASC services. ( a ) *Included facility services.* ASC services for which payment is packaged into the ASC payment for a covered surgical procedure under § 416.166 include, but are not limited to— ( 1 ) Nursing, technician, and related services;
( 2 ) Use of the facility where the surgical procedures are performed;
( 3 ) Any laboratory testing performed under a Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate of waiver;
( 4 ) Drugs and biologicals for which separate payment is not allowed under the hospital outpatient prospective payment system (OPPS), with the exception of non-opioid pain management drugs and biologicals that function as a supply when used in a surgical procedure as determined by CMS under § 416.174;
( 5 ) Medical and surgical supplies not on pass-through status under subpart G of part 419 of this subchapter;
( 6 ) Equipment;
( 7 ) Surgical dressings;
( 8 ) Implanted prosthetic devices, including intraocular lenses (IOLs), and related accessories and supplies not on pass-through status under subpart G of part 419 of this subchapter;
( 9 ) Implanted DME and related accessories and supplies not on pass-through status under subpart G of part 419 of this subchapter;
( 10 ) Splints and casts and related devices;
( 11 ) Radiology services for which separate payment is not allowed under the OPPS and other diagnostic tests or interpretive services that are integral to a surgical procedure, except certain diagnostic tests for which separate payment is allowed under the OPPS;
( 12 ) Administrative, recordkeeping and housekeeping items and services;
( 13 ) Materials, including supplies and equipment for the administration and monitoring of anesthesia; and
( 14 ) Supervision of the services of an anesthetist by the operating surgeon.
( b ) *Covered ancillary services.* Ancillary items and services that are integral to a covered surgical procedure, as defined in § 416.166, and for which separate payment is allowed include: ( 1 ) Brachytherapy sources;
( 2 ) Certain implantable items that have pass-through status under the OPPS;
( 3 ) Certain items and services that CMS designates as contractor-priced, including, but not limited to, the acquisition or procurement of corneal tissue for corneal transplant procedures;
( 4 ) Certain drugs and biologicals for which separate payment is allowed under the OPPS;
( 5 ) Certain radiology services and certain diagnostic tests for which separate payment is allowed under the OPPS; and
( 6 ) Non-opioid pain management drugs and biologicals that function as a supply when used in a surgical procedure as determined by CMS under § 416.174.
( c ) *Excluded services.* ASC services do not include items and services outside the scope of ASC services for which payment may be made under part 414 of this subchapter in accordance with § 410.152, including, but not limited to— ( 1 ) Physicians' services (including surgical procedures and all preoperative and postoperative services that are performed by a physician);
( 2 ) Anesthetists' services;
( 3 ) Radiology services (other than those integral to performance of a covered surgical procedure);
( 4 ) Diagnostic procedures (other than those directly related to performance of a covered surgical procedure);
( 5 ) Ambulance services;
( 6 ) Leg, arm, back, and neck braces other than those that serve the function of a cast or splint;
( 7 ) Artificial limbs;
( 8 ) Nonimplantable prosthetic devices and DME.
[72 FR 42545, Aug. 2, 2007, as amended at 79 FR 67030, Nov. 10, 2014; 80 FR 70604, Nov. 13, 2015; 83 FR 59178, Nov. 21, 2018; 86 FR 63992, Nov. 16, 2021]