(Manual Name)

There is a payment adjustment for insertion of an IOL approved as belonging to a class of NTIOLs, for the 5- year period of time established for that class, as set forth at 42 CFR 416.200 . Covered ancillary items and services that are integral to a covered surgical procedure, as defined in 42 CFR 416.61, and for which separate payment to the ASC is allowed include:   (b)  Covered ancillary services   (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 procurement of corneal tissue;   (4) Certain drugs and biologicals for which separate payment is allowed under the OPPS;   (5) Certain radiology services for which separate payment is allowed under the OPPS.   NOTE:  Effective for dates of service on or after January 1, 2009, for allowed ASC claims, if modifier = TC, contractors must ensure that either:    ordering physician name and NPI or   referring physician name and NPI   are presen t on electronic or paper claims.   If this information is missing, contractors shall return as unprocessable.   The contractor shall use the following remittance advice messages and associated codes when returning claims under this policy.  This CARC/RARC combination is compliant with CAQH CORE Business Scenario Two.   Group Code: CO  CARC: 16  RARC: N264, N265, N285 or N286 as appropriate  MSN: N/A  Definitions of ASC Facility Services:   Nursing Services, Services of Technical Personnel, and Other Related Serv ices  These include all services in connection with covered procedures furnished by nurses and technical personnel who are employees of the ASC.  In addition to the nursing staff, this category includes orderlies, technical personnel, and others involved i n patient care.   Use by the Patient of the ASC Facilities   This category includes operating and recovery rooms, patient preparation areas, waiting rooms, and other areas used by the patient or offered for use by the patients relatives in connection with s urgical services.   Drugs, Biologicals, Surgical Dressings, Supplies, Splints, Casts, Appliances, and Equipment   This category includes all supplies and equipment commonly furnished by the ASC in connection with surgical procedures.  See the following paragraphs for certain exceptions.  Drugs and biologicals are limited to those which cannot be self -administered. See the Medicare Benefit Policy Manual, Chapter 15, 50.2, for a description of how to determine whether drugs can be self -administered.   Under Par t B, coverage for surgical dressings is limited to primary dressings, i.e., therapeutic and protective coverings applied directly to lesions on the skin or on openings to the skin required as the result of surgical procedures.  (Items such as Ace bandages,  elastic stockings and support hose, Spence boots and other foot coverings, leotards, knee supports, surgical leggings, gauntlets and pressure garments for the arms and hands are used as secondary coverings and therefore are not covered as surgical dressin gs.) Although surgical dressings usually are covered as incident to a physicians service in a physicians office setting, in the ASC setting, such dressings are included in the facilitys services.   However, surgical dressings may be reapplied later by others, including the patient or a member of his family.  When surgical dressings are obtained by the patient on a physicians order from a supplier, e.g., a drugstore, the surgical dressing is covered under Part B.  The same policy applies in the case of dressings obtained by the patient on a physicians order following surgery in an ASC; the dressings are covered and paid as a Part B service by the DME MAC.   Similarly, other supplies, splints, and casts include only those furnished by the ASC at the tim e of the surgery.  Additional covered supplies and materials furnished later are generally furnished as incident to a physicians service, not as an ASC facility service.  The term supplies includes those required for both the patient and ASC personnel , e.g., gowns, masks, drapes, hoses, and scalpels, whether disposable or reusable. Payment for these is included in the rate for the surgical procedure.   Beginning January 1, 2008, the ASC facility payment for a surgical procedure includes payment for drugs and biologicals that are not usually self -administered and that are considered to be packaged into the payment for the surgical procedure under the OPPS.  Also, beginning January 1, 2008, Medicare makes separate payment to ASCs for drugs and biologicals that are furnished integral to an ASC covered surgical procedure and that are separately payable under the OPPS.   Diagnostic or Therapeutic Items and Services   These are items and services furnished by ASC staff in connection with covered surgical procedures.  Many ASCs perform diagnostic tests prior to surgery that are generally included in the facility charges, such as urinalysis, blood hemoglobin, hematocrit l evels, etc.  To the extent that such simple tests are included in the ASC facility charges, they are considered facility services.  However, under the Medicare program, diagnostic tests are not covered in laboratories independent of a physicians office, r ural health clinic, or hospital unless the laboratories meet the regulatory requirements for the conditions for coverage of services of independent laboratories.  (See 42 CFR 416.49)  Therefore, diagnostic tests performed by the ASC other than those genera lly included in the facilitys charge are not covered under Part B and are not to be billed as diagnostic tests.  If the ASC has its laboratory certified, the laboratory itself may bill for the tests performed.   The ASC may make arrangements with an indepe ndent laboratory or other laboratory, such as a hospital laboratory, to perform diagnostic tests it requires prior to surgery.  In general, however, the necessary laboratory tests are done outside the ASC prior to scheduling of surgery, since the test resu lts often determine whether the beneficiary should have the surgery done on an outpatient basis in the first place.   Administrative, Recordkeeping and Housekeeping Items and Services  These include the general administrative functions necessary to run the facility e.g., scheduling, cleaning, utilities, and rent.  Blood, Blood Plasma, Platelets, etc., Except Those to Which Blood Deductible Applies   While covered procedures are not expected to result in extensive loss of blood, in some cases, blood or blood products are required.  Usually the blood deductible results in no expenses for blood or blood products being included under this provision.  However, where there is a need for blood or blood products beyond the deductible, they are considered ASC facility services and no separate charge is permitted to the beneficiary or the program.   Materials for Anesthesia   These include the anesthetic agents that are not paid separately under the OPPS, and any materials, whether disposable or re -usable, necessary for it s administration.   Intraocular Lenses (IOLs) and New Technology IOLs (NTIOLs)   The ASC facility services include IOLs (effective for services furnished on or after March 12, 1990), and NTIOLs (effective for services furnished on or after May 18, 2000), approved by the Food and Drug Administration (FDA) for insertion during or subsequent to cataract surgery.   FDA has classified IOLs into the following categories, any of which are included:   1. Anterior chamber angle fixation lenses;   2. Iris fixation lenses;   3. Irido -capsular fixation lenses; and   4. Posterior chamber lenses.   5. NTIOL Category 1 (as defined in Federal Register  Notice, VOL 65, dated May 3, 2000).  Note: This category expired May 18, 2005  6. NTIOL Category 2 (as defined in Federal Register  Notice, VOL 65, dated May 3, 2000).  Note:  This category expired May 18, 2005  7. NTIOL Category 3 (as defined in Federal  Register  Notice, 71 FR 4586, dated January 27, 2006):  This category will expire on February 26, 2011.  Note that while generally no separate charges for intraocular lenses (IOLs) are allowed, approved NTIOLS may be billed separately and an adjustment to the facility payment will be made for those lenses that are eligible.  (See 40.3.)   10.3 - Services Furnished in ASCs Which Are Not ASC Facility Services or Covered Ancillary Services  (Rev.  11793; Issued:01 -19-23; Effective: 02 -21-23; Implementation: 02 -21-23)  A single payment is made to an ASC for facility services furnished by the ASC in connection with a covered surgical procedure.  Additional payments may be made to the ASC for covered ancillary services, specifically brachytherapy  sources, certain implantable devices with pass- through status under the OPPS, corneal tissue acquisition, drugs and biologicals for which separate payment is allowed under the OPPS, radiology services for which separate payment is allowed under the OPPS, and certain other integral services not included in the primary procedure payment.  To be covered ancillary services for which separate payment is made, these items and services must be provided integral to covered surgical procedures, that is, immediately  before, during, or immediately after the covered surgical procedure.   However, a number of items and services covered under Medicare may be furnished in an ASC that are not considered ASC services, and which payment for ASC services does not include.  The se non- ASC services are covered and paid for under the applicable provisions of Part B.  In addition, the ASC may be part of a medical complex that includes other entities, such as an independent laboratory, supplier of durable medical equipment, or a phys icians office, which are covered as separate entities under Part B.  In general, an item or service provided in a separate part of the complex is not considered an ASC service, except as defined above.   Examples of payment and billing for items or service s that are not ASC services:   Items not included in payment for ASC services  Who may receive payment  Submit bills to:  Physicians services (including surgical procedures excluded from ASC payment)  Physician  A/B MAC (B)  The purchase or rental of non-implantable durable medical equipment (DME) to ASC patients for use in their homes  Supplier - An ASC can be a supplier of DME if it has a supplier number from the National Supplier Clearinghouse. DME MAC, or A/B MAC (B) as directed by the current DME jurisdiction list  Non-implantable prosthetic devices  Supplier.  An ASC can be a supplier of non- implantable prosthetics if it has a supplier number from the National Supplier Clearinghouse.  DME MAC, or A/B MAC (B), as directed by the current DME jurisdictio n list Ambulance services  Certified Ambulance supplier  A/B MAC (B)  Leg, arm, back and neck braces  Supplier  DME MAC, or A/B MAC (B), as directed by the current DME jurisdiction list  Artificial legs, arms, and eyes Supplier  DME MAC, or A/B MAC (B), as directed by the current DME jurisdiction list  Services furnished by an independent laboratory  Certified lab.  ASCs can receive lab certification and a CLIA number.  A/B MAC (B)  Facility services for surgical procedures excluded from the ASC list  ASC  ASC bills beneficiary for facility charges associated with the non -covered procedure   Examples of payment and billing for items or services that are included in payment for ASC facility services beginning January 1, 2008  Items included in payment for ASC facility services beginning January 1, 2008 Who may receive payment beginning January 1, 2008 Submit bills to: Implantable DME and accessories without OPPS pass -through status  ASC  A/B MAC (B) Implantable nonpass -through prosthetic devices (except NTIOLs), and accessories without OPPS pass -through status  ASC  A/B MAC (B) Radiology services for which there is no separate OPPS payment  ASC  A/B MAC (B) Drugs and biologicals for which there is no separate OPPS payment  ASC  A/B MAC (B)  10.4 - Coverage of Services in ASCs That Are Not ASC Facility Services or Covered Ancillary Services  (Rev.  11793; Issued:01 -19-23; Effective: 02 -21-23; Implementation: 02 -21-23)  Physicians Services - This category includes most covered services performed in ASCs that are not considered ASC services.  Physicians who furnish services in ASCs may bill for and receive separate payment under Part B.  Physicians services include the services of anesthesi ologists administering or supervising the administration of anesthesia to beneficiaries in ASCs and the beneficiaries recovery from the anesthesia.  The term physicians services also includes any routine pre - or post - operative services, such as office v isits, consultations, diagnostic tests, removal of stitches, changing of dressings, and other services which the individual physician usually includes in the fee for a given surgical procedure.