(Medicare Benefit Policy Manual)

Physicians services (including the services of residents and interns in unapproved teaching programs);   Physician assistant services, furnished after December 31, 1990;   Certified nurse -midwife services, as described in 180, furnished after December 31, 1990; and  Qualified clinical psychologist services, as defined in 160, furnished after December 31, 1990;   Screening mammography services;   Screening pap smears and pelvic exams;   Screening glaucoma services;   Influenza, pneumococcal pneumonia, and hepatitis B vaccines and their administrations;   Colorectal screening;   Bone mass measurements; and   Prostate screening;   Pneumococcal and hepatitis B vaccine services must be provided directly or arranged for by the hospital in order to be covered when furnished to a hospital inpatient.  The other services listed are not subject to bundling but, because they are excluded from the statutory definition of inpatient hospital services, may be covered only under Part B.  Payment may be made under Part B to a hospital (or critical access hospital) for certain medical and other health services furnished to its inpatients as provided in Chapter 6, 10 of this manual, Medical and Other Health Services Furnished to Inpatients of Participating Hospitals.   Payment may be made under Part B for certain medical and other health services if the beneficiary is an inpatient of a skilled nursing facility (SNF) as provided in chapter 8,  70ff of this manual.   260 - Ambulatory Surgical Center Services  (Rev. 77; Issued: 08- 29-07; Effective: 01 -01-08; Implementation:  01- 07-08)  Facility services furnished by ambulatory surgical centers (ASCs) in connection with certain surgical procedures are covered under Part B.  To receive coverage of and payment for its services under this provision, a facility must be certified as meeting the requirements for an ASC and enter into a written agreement with CMS.  Medicare periodically updates the list of covered procedures and related payment amounts through release of regulations and change requests.  The ASC must accept Medicares payment for such procedures as payment in full with respect to those services defined as ASC facility services.   Where services are performed in an ASC, the physician and others who perform covered services may also be paid for his/her professional services; however, the professional rate is then adjusted since the ASC incurs the facility costs.   260.1 - Definition of Ambulatory Surgical Center (ASC)  (Rev. 104; Issued:  03- 13-09; Effective Date:  04 -01-09; Implementation Date:  04-06-09)  An ASC for purposes of this benefit is a distinct entity that operates exclusively for the purpose of furnishing outpatient surgical services to patients. It enters into an agreement with CMS to do so.  An ASC is either independent (i.e., not a part of a provider of services or any other facility), or operated by a hospital (i.e., under the common ownership, licensure, or control of a hospital).  To be covered as an ASC operated by a hospital, a facility elects to do so, and continues to be so covered unles s CMS determines there is good cause to do otherwise.  This provision is intended to prohibit such an entity from switching from one payment method to another to maximize its revenues (47 FR 34082, 34099, Aug. 5, 1982).  For other general conditions and re quirements, see 42 CFR 416.25- 416.49. If the hospital based surgery center is certified as an ASC it is considered an ASC and is subject to rules for ASCs.  Related survey requirements are published in the State Operations Manual, Pub. 100- 07, Appendix L.  Claims processing and payment requirements for ASCs are published in Pub. 100- 04, the Medicare Claims Processing Manual, chapter 14.   If a hospital based surgery center is not certified as an ASC it continues under the program as part of the hospital. In that case the applicable hospital outpatient payment rules apply.  This is the outpatient prospective payment system (OPPS), for most hospitals, or may be provisions for hospitals excluded from OPPS.  See Pub.100- 04, the Medicare Claims Processing Manual, chapter 4, for billing and payment requirements for hospital outpatient services.  Indian Health Service (IHS) hospital outpatient departments are not certified as separate ASC entities.  The ASC indication merely means that CMS approved them to bill for ASC services and be paid based on the ASC rates for services on the ASC list.  In order to bill for ASC services, the hospital outpatient department must meet the conditions of participation for hospitals defined at 42 CFR, Part 482.  See Pub. 100- 04, the Medicare Claims Processing Manual, chapter 19, sections 40.2.1, and 80.9 for more information on IHS hospital outpatient departments billing for ASC services.   260.2 - Ambulatory Surgical Center Services  (Rev. 77; Issued: 08- 29-07; Effective: 01 -01-08; Implementation:  01- 07-08)  The ASC facility services are services furnished in an ASC in connection with a covered surgical procedure that are otherwise covered if furnished on an inpatient or outpatient basis in a hospital in connection with that procedure.  Not included in the def inition of facility services are medical and other health services, even though furnished within the ASC, which are covered under other portions of the Medicare program, or not furnished in connection with covered surgical procedures.  This distinction bet ween covered ASC facility services and services which are not covered ASC facility services is important, since the facility payment rate includes only the covered ASC facility services.  Services, which are not covered ASC facility services such as physic ians services and prosthetic devices other than intraocular lenses (IOLs), may be covered and billable under other Medicare provisions.  Since there is no uniformity among ASCs as to what items and services they include in their facility fee or charge, the Medicare definition of covered facility services is both inclusive and exclusive.  The regulations specify what are and are not facility services.  Facility services are items and services furnished in connection with listed covered procedures, which are covered if furnished in a hospital operating suite or hospital outpatient department in connection with such procedures.  These do not in clude physicians services, or medical and other health services for which payment may be made under other Medicare provisions (e.g., services of an independent laboratory located on the same site as the ASC, anesthetist professional services, non -implanta ble DME).   Examples of covered ASC facility services include:   Nursing Services, Services of Technical Personnel, and Other Related Services   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 in pati ent care;   Use by the Patient of the ASCs 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 surgical services; and  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 below for certain exceptions.  Drugs and biologicals are limited to those that cannot be self -administered.   (See 60.)  Coverage policy for surgical dressings is similar to that followed under Part B.  Under Part 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 generally used as secondary coverings and therefore are not covered as surgical dressings.)  Surgical dressings usually are applied first by a physician and 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, others may reapply surgical dressings later, including the patient or a member of the patients family.  When the patient on a physicians order obtains surgical dressings 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 local A/B MAC (B) , included in the definition of facility se rvices.   Similarly, other supplies, splints, and casts include only those furnished by the ASC at the time of the surgery.  Additional covered supplies and materials furnished later are generally furnished as incident to a physicians service, not as an ASC fac ility 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.  Diagnostic or Therapeutic Items and Services   These are items and services furnished by ASC staff in connection with covered surgical procedures.  With respect to diagnostic tests, many ASCs perform simple tests just before surgery, primarily urinalysis and blood hemoglobin or hematocrit, which are generally included in their facility charges.  To the extent that such simple tests are included in the ASCs facility charges, they are considered facility services.  However, under the Medicare program, diagnostic tests are not covered in laboratories independent of a physicians office, rural 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 generally included in the facilitys charge are not covered under Part B as such and are not billed to the A/B MAC (B) as diagnostic tests.  If the ASC has its laboratory certified as meeting the regulatory conditions, then the laboratory itself bills the A/B MAC (B) (or the beneficiary) for the tests performed.   The ASC may make arrangements with an independent 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 results often determine whether the beneficiary should even 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 limited to those 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 itself, and any materials, whether disposable or reusable, necessary for its administration.   Intraocular Lenses (IOLs)   Effective for services furnished on or after March 12, 1990, ASC facility services include intraocular lenses approved by the Food and Drug Administration (FDA) for insertion during or subsequent to cataract surgery.  FDA has classified IOLs into the following four categories, any of which are included:  Anterior chamber angle fixation lenses;  Iris fixation lenses;  Irido -capsular fixation lenses; and Posterior chamber lenses.   While FDA has approved many IOLs, it still considers some IOLs investigational.  The fact that they are covered under Medicare is an exception to the general policy not to cover experimental or investigational items or services.  The exception is made because the Congress, recognizing the widespread use of IOLs, directed the FDA to study them without interfering with availability to patients.   The A/B MAC (B) determines whether the item or service falls into the categories described in the following section.  If it determines the item or service does fall into one of those categories, it makes payment following the applicable rules for such items and services found elsewhere in this chapter.  If the item or service does not fall into one of the categories described, the A/B MAC (B) denies the claim.   Covered ASC surgical procedures are those surgical procedures that are identified by CMS on an annually updated ASC listing.  Some surgical procedures covered by Medicare are not on the ASC list of covered surgical procedures.  Under the revised ASC payment system, Medicare makes facility payments to ASCs only for the specific ASC covered surgical procedures and covered ancillary services that are provided integral to a covered ASC surgical procedure.  See chapter 14, section 10 of Pub. 100-04, Medicare Claims Processing Manual for examples of covered ASC services for which payment is included in the ASC payment for a covered surgical procedure under 42CFR416.65.  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 42CFR416.200.