42 C.F.R. PART 416—AMBULATORY SURGICAL SERVICES
Title 42 - Public Health
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Source: 47 FR 34094, Aug. 5, 1982, unless otherwise noted.
(a) Statutory basis. (1) Section 1832(a)(2)(F)(i) of the Act provides for Medicare Part B coverage of facility services furnished in connection with surgical procedures specified by the Secretary under section 1833(i)(1) of the Act. (2) Section 1833(i)(1)(A) of the Act requires the Secretary to specify the surgical procedures that can be performed safely on an ambulatory basis in an ambulatory surgical center, or a hospital outpatient department. (3) Section 1833(i) (2)(A) and (3) specify the amounts to be paid for facility services furnished in connection with the specified surgical procedures when they are performed, respectively, in an ASC, or in a hospital outpatient department. (b) Scope. This part sets forth— (1) The conditions that an ASC must meet in order to participate in the Medicare program; (2) The scope of covered services; and (3) The conditions for Medicare payment for facility services. [56 FR 8843, Mar. 1, 1991; 56 FR 23022, May 20, 1991] As used in this part: Ambulatory surgical center or ASC means any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization, has an agreement with CMS to participate in Medicare as an ASC, and meets the conditions set forth in subparts B and C of this part. ASC services means facility services that are furnished in an ASC. Covered surgical procedures means those surgical and other medical procedures that meet the criteria specified in §416.65 and are published by CMS in the Facility services means services that are furnished in connection with covered surgical procedures performed in an ASC, or in a hospital on an outpatient basis. [56 FR 8843, Mar. 1, 1991; 56 FR 23022, May 20, 1991] Participation as an ASC is limited to facilities that— (a) Meet the definition in §416.2; and (b) Have in effect an agreement obtained in accordance with this subpart. [56 FR 8843, Mar. 1, 1991] (a) Deemed compliance. CMS may deem an ASC to be in compliance with any or all of the conditions set forth in subpart C of this part if— (1) The ASC is accredited by a national accrediting body, or licensed by a State agency, that CMS determines provides reasonable assurance that the conditions are met; (2) In the case of deemed status through accreditation by a national accrediting body, where State law requires licensure, the ASC complies with State licensure requirements; and (3) The ASC authorizes the release to CMS, of the findings of the accreditation survey. (b) Survey of ASCs. (1) Unless CMS deems the ASC to be in compliance with the conditions set forth in subpart C of this part, the State survey agency must survey the facility to ascertain compliance with those conditions, and report its findings to CMS. (2) CMS surveys deemed ASCs on a sample basis as part of CMS's validation process. (c) Acceptance of the ASC as qualified to furnish ambulatory surgical services. If CMS determines, after reviewing the survey agency recommendation and other evidence relating to the qualification of the ASC, that the facility meets the requirements of this part, it sends to the ASC— (1) Written notice of the determination; and (2) Two copies of the ASC agreement. (d) Filing of agreement by the ASC. If the ASC wishes to participate in the program, it must— (1) Have both copies of the ASC agreement signed by its authorized representative; and (2) File them with CMS. (e) Acceptance by CMS. If CMS accepts the agreement filed by the ASC, returns to the ASC one copy of the agreement, with a notice of acceptance specifying the effective date. (f) Appeal rights. If CMS refuses to enter into an agreement or if CMS terminates an agreement, the ASC is entitled to a hearing in accordance with part 498 of this chapter. [56 FR 8843, Mar. 1, 1991] As part of the agreement under §416.26 the ASC must agree to the following: (a) Compliance with coverage conditions. The ASC agrees to meet the conditions for coverage specified in subpart C of this part and to report promptly to CMS any failure to do so. (b) Limitation on charges to beneficiaries.1 1 For facility services furnished before July 1987, the ASC had to agree to make no charge to the beneficiary, since those services were not subject to the part B deductible and coinsurance provisions. (1) Is entitled to have payment made on his or her behalf under this part; or (2) Would have been so entitled if the ASC had filed a request for payment in accordance with §410.165 of this chapter. (c) Refunds to beneficiaries. (1) The ASC agrees to refund as promptly as possible any money incorrectly collected from beneficiaries or from someone on their behalf. (2) As used in this section, money incorrectly collected means sums collected in excess of those specified in paragraph (b) of this section. It includes amounts collected for a period of time when the beneficiary was believed not to be entitled to Medicare benefits if— (i) The beneficiary is later determined to have been entitled to Medicare benefits; and (ii) The beneficiary's entitlement period falls within the time the ASC's agreement with CMS is in effect. (d) Furnishing information. The ASC agrees to furnish to CMS, if requested, information necessary to establish payment rates specified in §§416.120–416.130 in the form and manner that CMS requires. (e) Acceptance of assignment. The ASC agrees to accept assignment for all facility services furnished in connection with covered surgical procedures. For purposes of this section, assignment means an assignment under §424.55 of this chapter of the right to receive payment under Medicare Part B and payment under §424.64 of this chapter (when an individual dies before assigning the claim). (f) ASCs operated by a hopsital. In an ASC operated by a hospital— (1) The agreement is made effective on the first day of the next Medicare cost reporting period of the hospital that operates the ASC; and (2) The ASC participates and is paid only as an ASC, without the option of converting to or being paid as a hospital outpatient department, unless CMS determines there is good cause to do otherwise. (3) Costs for the ASC are treated as a non-reimbursable cost center on the hopsital's cost report. (g) Additional provisions. The agreement may contain any additional provisions that CMS finds necessary or desirable for the efficient and effective administration of the Medicare program. [47 FR 34094, Aug. 5, 1982, as amended at 51 FR 41351, Nov. 14, 1986; 56 FR 8844, Mar. 1, 1991] (a) Termination by the ASC—(1) Notice to CMS. An ASC that wishes to terminate its agreement must send CMS written notice of its intent. (2) Date of termination. The notice may state the intended date of termination which must be the first day of a calendar month. (i) If the notice does not specify a date, or the date is not acceptable to CMS, CMS may set a date that will not be more than 6 months from the date on the ASC's notice of intent. (ii) CMS may accept a termination date that is less than 6 months after the date on the ASC's notice if it determines that to do so would not unduly disrupt services to the community or otherwise interfere with the effective and efficient administration of the Medicare program. (3) Voluntary termination. If an ASC ceases to furnish services to the community, that shall be deemed to be a voluntary termination of the agreement by the ASC, effective on the last day of business with Medicare beneficiaries. (b) Termination by CMS—(1) Cause for termination. CMS may terminate an agreement if it determines that the ASC— (i) No longer meets the conditions for coverage as specified under §416.26; or (ii) Is not in substantial compliance with the provisions of the agreement, the requirements of this subpart, and other applicable regulations of subchapter B of this chapter, or any applicable provisions of title XVIII of the Act. (2) Notice of termination. CMS sends notice of termination to the ASC at least 15 days before the effective date stated in the notice. (3) Appeal by the ASC. An ASC may appeal the termination of its agreement in accordance with the provisions set forth in part 498 of this chapter. (c) Effect of termination. Payment is not available for ASC services furnished on or after the effective date of termination. (d) Notice to the public. Prompt notice of the date and effect of termination is given to the public, through publication in local newspapers by— (1) The ASC, after CMS has approved or set a termination date; or (2) CMS, when it has terminated the agreement. (e) Conditions for reinstatement after termination of agreement by CMS. When an agreement with an ASC is terminated by CMS, the ASC may not file another agreement to participate in the Medicare program unless CMS— (1) Finds that the reason for the termination of the prior agreement has been removed; and (2) Is assured that the reason for the termination will not recur. [47 FR 34094, Aug. 5, 1982, as amended at 52 FR 22454, June 12, 1987; 56 FR 8844, Mar. 1, 1991; 61 FR 40347, Aug. 2, 1996] The ASC must comply with State licensure requirements. The ASC must have a governing body, that assumes full legal responsibility for determining, implementing, and monitoring policies governing the ASC's total operation and for ensuring that these policies are administered so as to provide quality health care in a safe environment. When services are provided through a contract with an outside resource, the ASC must assure that these services are provided in a safe and effective manner. Standard: Hospitalization. The ASC must have an effective procedure for the immediate transfer to a hospital, of patients requiring emergency medical care beyond the capabilities of the ASC. This hospital must be a local, Medicare participating hospital or a local, nonparticipating hospital that meets the requirements for payment for emergency services under §482.2 of this chapter. The ASC must have a written transfer agreement with such a hospital, or all physicians performing surgery in the ASC must have admitting privileges at such a hospital. [47 FR 34094, Aug. 5, 1982, as amended at 51 FR 22041, June 17, 1986] Surgical procedures must be performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body of the ASC in accordance with approved policies and procedures of the ASC. (a) Standard: Anesthetic risk and evaluation. A physician must examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. Before discharge from the ASC, each patient must be evaluated by a physician for proper anesthesia recovery. (b) Standard: Administration of anesthesia. Anesthetics must be administered by only— (1) A qualified anesthesiologist; or (2) A physician qualified to administer anesthesia, a certified registered nurse anesthetist (CRNA) or an anesthesiologist's assistant as defined in §410.69(b) of this chapter, or a supervised trainee in an approved educational program. In those cases in which a non-physician administers the anesthesia, unless exempted in accordance with paragraph (d) of this section, the anesthetist must be under the supervision of the operating physician, and in the case of an anesthesiologist's assistant, under the supervision of an anesthesiologist. (c) Standard: Discharge. All patients are discharged in the company of a responsible adult, except those exempted by the attending physician. (d) Standard: State exemption. (1) An ASC may be exempted from the requirement for physician supervision of CRNAs as described in paragraph (b)(2) of this section, if the State in which the ASC is located submits a letter to CMS signed by the Governor, following consultation with the State's Boards of Medicine and Nursing, requesting exemption from physician supervision of CRNAs. The letter from the Governor must attest that he or she has consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State's citizens to opt-out of the current physician supervision requirement, and that the opt-out is consistent with State law. (2) The request for exemption and recognition of State laws, and the withdrawal of the request may be submitted at any time, and are effective upon submission. [57 FR 33899, July 31, 1992, as amended at 66 FR 56768, Nov. 13, 2001.] The ASC, with the active participation of the medical staff, must conduct an ongoing, comprehensive self-assessment of the quality of care provided, including medical necessity of procedures performed and appropriateness of care, and use findings, when appropriate, in the revision of center policies and consideration of clinical privileges. The ASC must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients. (a) Standard: Physical environment. The ASC must provide a functional and sanitary environment for the provision of surgical services. (1) Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area. (2) The ASC must have a separate recovery room and waiting area. (3) The ASC must establish a program for identifying and preventing infections, maintaining a sanitary environment, and reporting the results to appropriate authorities. (b) Standard: Safety from fire. (1) Except as otherwise provided in this section, the ASC must meet the provisions applicable to Ambulatory Health Care Centers of the 2000 edition of the Life Safety Code of the National Fire Protection Association, regardless of the number of patients served. The Director of the Office of the Federal Register has approved the NFPA 101® 2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the (2) In consideration of a recommendation by the State survey agency, CMS may waive, for periods deemed appropriate, specific provisions of the Life Safety Code which, if rigidly applied, would result in unreasonable hardship upon an ASC, but only if the waiver will not adversely affect the health and safety of the patients. (3) The provisions of the Life Safety Code do not apply in a State if CMS finds that a fire and safety code imposed by State law adequately protects patients in an ASC. (4) An ASC must be in compliance with Chapter 21.2.9.1, Emergency Lighting, beginning on March 13, 2006. (5) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, an ASC may place alcohol-based hand rub dispensers in its facility if— (i) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities; (ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls; (iii) The dispensers are installed in a manner that adequately protects against access by vulnerable populations; and (iv) The dispensers are installed in accordance with the following provisions: (A) Where dispensers are installed in a corridor, the corridor shall have a minimum width of 6 ft (1.8m); (B) The maximum individual dispenser fluid capacity shall be: (1) 0.3 gallons (1.2 liters) for dispensers in rooms, corridors, and areas open to corridors. (2) 0.5 gallons (2.0 liters) for dispensers in suites of rooms; (C) The dispensers shall have a minimum horizontal spacing of 4 ft (1.2m) from each other; (D) Not more than an aggregate 10 gallons (37.8 liters) of ABHR solution shall be in use in a single smoke compartment outside of a storage cabinet; (E) Storage of quantities greater than 5 gallons (18.9 liters) in a single smoke compartment shall meet the requirements of NFPA 30, Flammable and Combustible Liquids Code; (F) The dispensers shall not be installed over or directly adjacent to an ignition source; and (G) In locations with carpeted floor coverings, dispensers installed directly over carpeted surfaces shall be permitted only in sprinklered smoke compartments. (c) Standard: Emergency equipment. Emergency equipment available to the operating rooms must include at least the following: (1) Emergency call system. (2) Oxygen. (3) Mechanical ventilatory assistance equipment including airways, manual breathing bag, and ventilator. (4) Cardiac defibrillator. (5) Cardiac monitoring equipment. (6) Tracheostomy set. (7) Laryngoscopes and endotracheal tubes. (8) Suction equipment. (9) Emergency medical equipment and supplies specified by the medical staff. (d) Standard: Emergency personnel. Personnel trained in the use of emergency equipment and in cardiopulmonary resuscitation must be available whenever there is a patient in the ASC. [47 FR 34094, Aug. 5, 1982, amended at 53 FR 11508, Apr. 7, 1988; 54 FR 4026, Jan. 27, 1989; 68 FR 1385, Jan. 10, 2003; 69 FR 18803, Apr. 9, 2004; 70 FR 15237, Mar. 25, 2005] The medical staff of the ASC must be accountable to the governing body. (a) Standard: Membership and clinical privileges. Members of the medical staff must be legally and professionally qualified for the positions to which they are appointed and for the performance of privileges granted. The ASC grants privileges in accordance with recommendations from qualified medical personnel. (b) Standard: Reappraisals. Medical staff privileges must be periodically reappraised by the ASC. The scope of procedures performed in the ASC must be periodically reviewed and amended as appropriate. (c) Standard: Other practitioners. If the ASC assigns patient care responsibilities to practitioners other than physicians, it must have established policies and procedures, approved by the governing body, for overseeing and evaluating their clinical activities. The nursing services of the ASC must be directed and staffed to assure that the nursing needs of all patients are met. (a) Standard: Organization and staffing. Patient care responsibilities must be delineated for all nursing service personnel. Nursing services must be provided in accordance with recognized standards of practice. There must be a registered nurse available for emergency treatment whenever there is a patient in the ASC. (b) [Reserved] The ASC must maintain complete, comprehensive, and accurate medical records to ensure adequate patient care. (a) Standard: Organization. The ASC must develop and maintain a system for the proper collection, storage, and use of patient records. (b) Standard: Form and content of record. The ASC must maintain a medical record for each patient. Every record must be accurate, legible, and promptly completed. Medical records must include at least the following: (1) Patient identification. (2) Significant medical history and results of physical examination. (3) Pre-operative diagnostic studies (entered before surgery), if performed. (4) Findings and techniques of the operation, including a pathologist's report on all tissues removed during surgery, except those exempted by the governing body. (5) Any allergies and abnormal drug reactions. (6) Entries related to anesthesia administration. (7) Documentation of properly executed informed patient consent. (8) Discharge diagnosis. The ASC must provide drugs and biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the direction of an individual designated responsible for pharmaceutical services. (a) Standard: Administration of drugs. Drugs must be prepared and administered according to established policies and acceptable standards of practice. (1) Adverse reactions must be reported to the physician responsible for the patient and must be documented in the record. (2) Blood and blood products must be administered by only physicians or registered nurses. (3) Orders given orally for drugs and biologicals must be followed by a written order, signed by the prescribing physician. (b) [Reserved] If the ASC performs laboratory services, it must meet the requirements of part 493 of this chapter. If the ASC does not provide its own laboratory services, it must have procedures for obtaining routine and emergency laboratory services from a certified laboratory in accordance with part 493 of this chapter. The referral laboratory must be certified in the appropriate specialties and subspecialties of service to perform the referred tests in accordance with the requirements of part 493 of this chapter. The ASC must have procedures for obtaining radiologic services from a Medicare approved facility to meet the needs of patients. [57 FR 7135, Feb. 28, 1992] (a) The services payable under this part are facility services furnished to Medicare beneficiaries, by a participating facility, in connection with covered surgical procedures specified in §416.65. (b) The surgical procedures, including all preoperative and post-operative services that are performed by a physician, are covered as physician services under part 410 of this chapter. [56 FR 8844, Mar. 1, 1991] (a) Included services. Facility services include, but are not limited to— (1) Nursing, technician, and related services; (2) Use of the facilities where the surgical procedures are performed; (3) Drugs, biologicals, surgical dressings, supplies, splints, casts, and appliances and equipment directly related to the provision of surgical procedures; (4) Diagnostic or therapeutic services or items directly related to the provision of a surgical procedure; (5) Administrative, recordkeeping and housekeeping items and services; and (6) Materials for anesthesia. (7) Intra-ocular lenses (IOLs). (8) Supervision of the services of an anesthetist by the operating surgeon. (b) Excluded services. Facility services do not include items and services for which payment may be made under other provisions of part 405 of this chapter, such as physicians' services, laboratory, X-ray or diagnostic procedures (other than those directly related to performance of the surgical procedure), prosthetic devices (except IOLs), ambulance services, leg, arm, back and neck braces, artificial limbs, and durable medical equipment for use in the patient's home. In addition, they do not include anesthetist services furnished on or after January 1, 1989. [56 FR 8844, Mar. 1, 1991, as amended at 57 FR 33899, July 31, 1992] 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 with paragraph (c) of this section. (a) General standards. Covered surgical procedures are those surgical and other medical procedures that— (1) Are commonly performed on an inpatient basis in hospitals, but may be safely performed in an ASC; (2) Are not of a type that are commonly performed, or that may be safely performed, in physicians' offices; (3) Are limited to those requiring a dedicated operating room (or suite), and generally requiring a post-operative recovery room or short-term (not overnight) convalescent room; and (4) Are not otherwise excluded under §405.310 of this chapter. (b) Specific standards. (1) Covered surgical procedures are limited to those that do not generally exceed— (i) A total of 90 minutes operating time; and (ii) A total of 4 hours recovery or convalescent time. (2) If the covered surgical procedures require anesthesia, the anesthesia must be— (i) Local or regional anesthesia; or (ii) General anesthesia of 90 minutes or less duration. (3) Covered surgical procedures may not be of a type that— (i) Generally result in extensive blood loss; (ii) Require major or prolonged invasion of body cavities; (iii) Directly involve major blood vessels; or (iv) Are generally emergency or life-threatening in nature. (c) Publication of covered procedures. CMS will publish in the The inclusion of any procedure as a covered surgical procedure under §416.65 does not preclude its coverage in an inpatient hospital setting under Medicare. The basis for payment depends on where the services are furnished. (a) Hospital outpatient department. Payment is in accordance with part 413 of this chapter. (b) [Reserved] (c) ASC—(1) General rule. Payment is based on a prospectively determined rate. This rate covers the cost of services such as supplies, nursing services, equipment, etc., as specified in §416.61. The rate does not cover physician services or other medical services covered under part 410 of this chapter (for example, X-ray services or laboratory services) which are not directly related to the performance of the surgical procedures. Those services may be billed separately and paid on a reasonable charge basis. (2) Single and multiple surgical procedures. (i) If one covered surgical procedure is furnished to a beneficiary in an operative session, payment is based on the prospectively determined rate for that procedure. (ii) If more than one surgical procedure is furnished in a single operative session, payment is based on— (A) The full rate for the procedure with the highest prospectively determined rate; and (B) One half of the prospectively determined rate for each of the other procedures. (3) Deductibles and coinsurance. Part B deductible and coinsurance amounts apply as specified in §410.152 (a) and (i) of this chapter. [56 FR 8844, Mar. 1, 1991; 56 FR 23022, May 20, 1991] (a) The payment rate is based on a prospectively determined standard overhead amount per procedure derived from an estimate of the costs incurred by ambulatory surgical centers generally in providing services furnished in connection with the performance of that procedure. (b) The payment must be substantially less than would have been paid under the program if the procedure had been performed on an inpatient basis in a hospital. [56 FR 8844, Mar. 1, 1991] Whenever CMS proposes to revise the payment rate for ASCs, CMS publishes a notice in the [47 FR 34094, Aug. 5, 1982, as amended at 56 FR 8844, Mar. 1, 1991] (a) Timing, purpose, and procedures. (1) No more often than once a year, CMS conducts a survey of a randomly selected sample of participating ASCs to collect data for analysis or reevaluation of payment rates. (2) CMS notifies the selected ASCs by mail of their selection and of the form and content of the report the ASCs are required to submit within 60 days of the notice. (3) If the facility does not submit an adequate report in response to CMS's survey request, CMS may terminate the agreement to participate in the Medicare program as an ASC. (4) CMS may grant a 30-day postponement of the due date for the survey report if it determines that the facility has demonstrated good cause for the delay. (b) Requirements for ASCs. ASCs must— (1) Maintain adequate financial records, in the form and containing the data required by CMS, to allow determination of the payment rates for covered surgical procedures furnished to Medicare beneficiaries under this subpart. (2) Within 60 days of a request from CMS submit, in the form and detail as may be required by CMS, a report of— (i) Their operations, including the allowable costs actually incurred for the period and the actual number and kinds of surgical procedures furnished during the period; and (ii) Their customary charges for each surgical procedure furnished for the period. [47 FR 34094, Aug. 5, 1982, as amended at 56 FR 8845, Mar. 1, 1991] A beneficiary (or ASC as his or her assignee) may request a hearing by a carrier (subject to the limitations and conditions set forth in part 405, subpart H of this chapter) if the beneficiary or the ASC— (a) Is dissatisfied with a carrier's denial of a request for payment made on his or her behalf by an ASC; (b) Is dissatisfied with the amount of payment; or (c) Believes the request for payment is not being acted upon with reasonable promptness. Source: 64 FR 32205, June 16, 1999, unless otherwise noted.
As used in this subpart, the following definitions apply: Class of new technology intraocular lenses (IOLs) means all of the IOLs, collectively, that CMS determines meet the definition of “new technology IOL” under the provisions of this subpart. Interested party means any individual, partnership, corporation, association, society, scientific or academic establishment, professional or trade organization, or any other legal entity. New technology IOL means an IOL that CMS determines has been approved by the FDA for use in labeling and advertising the IOL's claims of specific clinical advantages and superiority over existing IOLs with regard to reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or other comparable clinical advantages. New technology subset means a group of IOLs that CMS determines meet the criterion for being treated as new technology IOLs and that share a common feature or features that distinguish them from other IOLs. For example, all new technology IOLs that are made of a particular bioengineered material could comprise one subset, while all that rely on a particular optical innovation could comprise another. (a) CMS publishes a (b) CMS receives a request to review the appropriateness of the payment amount for an IOL. (c) CMS compiles a list of the requests it receives and identifies the IOL manufacturer's name, the model number of the IOL to be reviewed, the interested party or parties that submit requests, and a summary of the interested party's grounds for requesting review of the appropriateness of the IOL payment amount. (d) CMS publishes the list of requests in a (e) CMS reviews the information submitted with the request to review, any timely public comments that are submitted regarding the list of IOLs published in the (f) If CMS determines that a lens is a new technology IOL, CMS establishes a payment adjustment as follows: (1) Before July 16, 2002—$50. (2) After July 16, 2002—$50 or the amount announced through proposed and final rulemaking in connection with ambulatory surgical center services. (g) CMS designates a predominant characteristic of a new technology IOL that both sets it apart from other IOLs and links it with other similar IOLs with the same characteristic to establish a specific subset of new technology within the “class of new technology IOLs.” (h) Within 90 days of the end of the comment period following the (i) Payment adjustments are effective beginning 30 days after the publication of CMS's determinations in the Any party who is able to furnish the information required in §416.195 may request that CMS review the appropriateness of the payment amount provided under section 1833(i)(2)(A)(iii) of the Act with respect to an IOL that meets the definition of a new technology IOL in §416.180. (a) Content of a request. The request must include all of the following information: (1) The name of the manufacturer, the model number, and the trade name of the IOL. (2) A copy of the FDA's summary of the IOL's safety and effectiveness. (3) A copy of the labeling claims of specific clinical advantages approved by the FDA for the IOL. (4) A copy of the IOL's original FDA approval notification. (5) Reports of modifications made after the original FDA approval. (6) Other information that CMS finds necessary for identification of the IOL. (b) Confidential information. To the extent that information received from an IOL manufacturer can reasonably be characterized as a trade secret or as privileged or confidential commercial or financial information, CMS maintains the confidentiality of the information and protects it from disclosure not otherwise authorized or required by Federal law as allowed under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552(b)(4)) and, with respect to trade secrets, the Trade Secrets Act (18 U.S.C. 1905). (a) CMS recognizes the IOL(s) that define a new technology subset for purposes of this subpart as belonging to the class of new technology IOLs for a period of 5 years effective from the date that CMS recognizes the first new technology IOL for a payment adjustment. (b) Any IOL that CMS subsequently recognizes as belonging to a new technology subset receives the new technology payment adjustment for the remainder of the 5-year period established with CMS's recognition of the first IOL in the subset. (c) Beginning 5 years after the effective date of CMS's initial recognition of a new technology subset, payment adjustments cease for all IOLs that CMS designates as belonging to that subset and payment reverts to the standard payment rate set under section 1833(i)(2)(A)(iii) of the Act for IOL insertion procedures performed in ASCs. (d) ASCs that furnish an IOL designated by CMS as belonging to the class of new technology IOLs must submit claims using specific billing codes to receive the new technology IOL payment adjustment.
Title 42: Public Health
PART 416—AMBULATORY SURGICAL SERVICES
Section Contents
§ 416.1 Basis and scope.
§ 416.2 Definitions.
§ 416.25 Basic requirements.
§ 416.26 Qualifying for an agreement.
§ 416.30 Terms of agreement with CMS.
§ 416.35 Termination of agreement.
§ 416.40 Condition for coverage—Compliance with State licensure law.
§ 416.41 Condition for coverage—Governing body and management.
§ 416.42 Condition for coverage—Surgical services.
§ 416.43 Condition for coverage—Evaluation of quality.
§ 416.44 Condition for coverage—Environment.
§ 416.45 Condition for coverage—Medical staff.
§ 416.46 Condition for coverage—Nursing services.
§ 416.47 Condition for coverage—Medical records.
§ 416.48 Condition for coverage—Pharmaceutical services.
§ 416.49 Condition for coverage—Laboratory and radiologic services.
§ 416.60 General rules.
§ 416.61 Scope of facility services.
§ 416.65 Covered surgical procedures.
§ 416.75 Performance of listed surgical procedures on an inpatient hospital basis.
§ 416.120 Basis for payment.
§ 416.125 ASC facility services payment rate.
§ 416.130 Publication of revised payment methodologies.
§ 416.140 Surveys.
§ 416.150 Beneficiary appeals.
§ 416.180 Definitions.
§ 416.185 Payment review process.
§ 416.190 Who may request a review.
§ 416.195 A request to review.
§ 416.200 Application of the payment adjustment.
Subpart A—General Provisions and Definitions
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§ 416.1 Basis and scope.
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§ 416.2 Definitions.
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Subpart B—General Conditions and Requirements
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§ 416.25 Basic requirements.
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§ 416.26 Qualifying for an agreement.
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§ 416.30 Terms of agreement with CMS.
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§ 416.35 Termination of agreement.
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Subpart C—Specific Conditions for Coverage
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§ 416.40 Condition for coverage—Compliance with State licensure law.
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§ 416.41 Condition for coverage—Governing body and management.
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§ 416.42 Condition for coverage—Surgical services.
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§ 416.43 Condition for coverage—Evaluation of quality.
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§ 416.44 Condition for coverage—Environment.
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§ 416.45 Condition for coverage—Medical staff.
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§ 416.46 Condition for coverage—Nursing services.
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§ 416.47 Condition for coverage—Medical records.
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§ 416.48 Condition for coverage—Pharmaceutical services.
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§ 416.49 Condition for coverage—Laboratory and radiologic services.
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Subpart D—Scope of Benefits
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§ 416.60 General rules.
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§ 416.61 Scope of facility services.
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§ 416.65 Covered surgical procedures.
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§ 416.75 Performance of listed surgical procedures on an inpatient hospital basis.
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Subpart E—Payment for Facility Services
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§ 416.120 Basis for payment.
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§ 416.125 ASC facility services payment rate.
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§ 416.130 Publication of revised payment methodologies.
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§ 416.140 Surveys.
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§ 416.150 Beneficiary appeals.
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Subpart F—Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers
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§ 416.180 Definitions.
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§ 416.185 Payment review process.
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§ 416.190 Who may request a review.
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§ 416.195 A request to review.
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§ 416.200 Application of the payment adjustment.
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