PART 416—AMBULATORY SURGICAL SERVICES Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh. Source: 47 FR 34094, Aug. 5, 1982, unless otherwise noted. Subpart A—General Provisions and Definitions § 416.1 Basis and scope. (a) Statutory basis. (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. (3) Sections 1833(i)(2)(A) and (D) and 1833(a)(1)(G) of the Act specify the amounts to be paid for facility services furnished in connection with the specified surgical procedures when they are performed in an ASC. (4) Section 1833(i)(2)(C) of the Act provides that if the Secretary has not updated amounts for ASC facility services furnished during a fiscal year through 2005 or a calendar year beginning with 2006, the amounts shall be increased by the percentage increase in the Consumer Price Index for all urban consumers as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved, except that, in fiscal year 2005, the last quarter of calendar year 2005, and each of the calendar years 2006 through 2009, the increase shall be zero percent. (5) Section 1833(i)(2)(E) of the Act provides that, with respect to surgical procedures furnished on or after January 1, 2007, and before the effective date of the implementation of a revised payment system, the payment amount shall be the lesser of the ASC payment rate established under section 1833(i)(2)(A) of the Act or the prospective payment rate for hospital outpatient department services established under section 1833(t)(3)(D) of the Act. The lesser payment amount shall be determined prior to application of any geographic adjustment. (b) Scope. (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 amended at 71 FR 68226, Nov. 24, 2006] § 416.2 Definitions. As used in this part: Ambulatory surgical center ASC ASC services Covered ancillary services Covered surgical procedures Facility services [56 FR 8843, Mar. 1, 1991; 56 FR 23022, May 20, 1991, as amended at 71 FR 68226, Nov. 24, 2006; 72 FR 42544, Aug. 2, 2007; 73 FR 68811, Nov. 18, 2008] Subpart B—General Conditions and Requirements § 416.25 Basic requirements. 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] § 416.26 Qualifying for an agreement. (a) Deemed compliance. (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. (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. (1) Written notice of the determination; and (2) Two copies of the ASC agreement. (d) Filing of agreement by the ASC. (1) Have both copies of the ASC agreement signed by its authorized representative; and (2) File them with CMS. (e) Acceptance by CMS. (f) Appeal rights. [56 FR 8843, Mar. 1, 1991] § 416.30 Terms of agreement with CMS. As part of the agreement under § 416.26 the ASC must agree to the following: (a) Compliance with coverage conditions. (b) Limitation on charges to beneficiaries. 1 1 (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. (2) As used in this section, money incorrectly collected (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. (e) Acceptance of assignment. (f) ASCs operated by a hopsital. (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. (3) Costs for the ASC are treated as a non-reimbursable cost center on the hopsital's cost report. (g) Additional provisions. [47 FR 34094, Aug. 5, 1982, as amended at 51 FR 41351, Nov. 14, 1986; 56 FR 8844, Mar. 1, 1991; 74 FR 60680, Nov. 20, 2009] § 416.35 Termination of agreement. (a) Termination by the ASC Notice to CMS. (2) Date of termination. (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. (b) Termination by CMS Cause for termination. (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. (3) Appeal by the ASC. (c) Effect of termination. (d) Notice to the public. (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. (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; 82 FR 38515, Aug. 14, 2017] Subpart C—Specific Conditions for Coverage § 416.40 Condition for coverage—Compliance with State licensure law. The ASC must comply with State licensure requirements. § 416.41 Condition for coverage—Governing body and management. The ASC must have a governing body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the ASC's total operation. The governing body has oversight and accountability for the quality assessment and performance improvement program, ensures that facility policies and programs are administered so as to provide quality health care in a safe environment, and develops and maintains a disaster preparedness plan. (a) Standard: Contract services. (b) Standard: Hospitalization. (2) 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. (3) The ASC must periodically provide the local hospital with written notice of its operations and patient population served. [73 FR 68811, Nov. 18, 2008, as amended at 81 FR 64022, Sept. 16, 2016; 84 FR 51814, Sep. 30, 2019] § 416.42 Condition for coverage—Surgical services. 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. (i) A physician must examine the patient to evaluate the risk of the procedure to be performed; and (ii) A physician or anesthetist as defined at § 410.69(b) of this chapter must examine the patient to evaluate the risk of anesthesia. (2) Before discharge from the ASC, each patient must be evaluated by a physician or by an anesthetist as defined at § 410.69(b) of this chapter, in accordance with applicable State health and safety laws, standards of practice, and ASC policy, for proper anesthesia recovery. (b) Standard: Administration of anesthesia. (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 (c) 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: State exemption. (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; 73 FR 68812, Nov. 18, 2008; 79 FR 27153, May 12, 2014; 84 FR 63202, Nov. 15, 2019] § 416.43 Conditions for coverage—Quality assessment and performance improvement. The ASC must develop, implement and maintain an ongoing, data-driven quality assessment and performance improvement (QAPI) program. (a) Standard: Program scope. (2) The ASC must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services furnished in the ASC. (b) Standard: Program data. (2) The ASC must use the data collected to— (i) Monitor the effectiveness and safety of its services, and quality of its care. (ii) Identify opportunities that could lead to improvements and changes in its patient care. (c) Standard: Program activities. (i) Focus on high risk, high volume, and problem-prone areas. (ii) Consider incidence, prevalence, and severity of problems in those areas. (iii) Affect health outcomes, patient safety, and quality of care. (2) Performance improvement activities must track adverse patient events, examine their causes, implement improvements, and ensure that improvements are sustained over time. (3) The ASC must implement preventive strategies throughout the facility targeting adverse patient events and ensure that all staff are familiar with these strategies. (d) Standard: Performance improvement projects. (2) The ASC must document the projects that are being conducted. The documentation, at a minimum, must include the reason(s) for implementing the project, and a description of the project's results. (e) Standard: Governing body responsibilities. (1) Is defined, implemented, and maintained by the ASC. (2) Addresses the ASC's priorities and that all improvements are evaluated for effectiveness. (3) Specifies data collection methods, frequency, and details. (4) Clearly establishes its expectations for safety. (5) Adequately allocates sufficient staff, time, information systems and training to implement the QAPI program. [73 FR 68812, Nov. 18, 2008] § 416.44 Condition for coverage—Environment. 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. (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. (b) Standard: Safety from fire. (2) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which 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 may place alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access. (5) When a sprinkler system is shut down for more than 10 hours, the ASC must: (i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or (ii) Establish a fire watch until the system is back in service. (6) Beginning July 5, 2017, an ASC must be in compliance with Chapter 21.3.2.1, Doors to hazardous areas. (c) Standard: Building Safety. (1) Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to an ASC. (2) If application of the Health Care Facilities Code required under paragraph (c) of this section would result in unreasonable hardship for the ASC, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of patients. (d) Standard: Emergency equipment. (1) Be immediately available for use during emergency situations. (2) Be appropriate for the facility's patient population. (3) Be maintained by appropriate personnel. (e) Standard: Emergency personnel. (f) The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or 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.html. Federal Register (1) National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org (i) NFPA 99, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011. (ii) TIA 12-2 to NFPA 99, issued August 11, 2011. (iii) TIA 12-3 to NFPA 99, issued August 9, 2012. (iv) TIA 12-4 to NFPA 99, issued March 7, 2013. (v) TIA 12-5 to NFPA 99, issued August 1, 2013. (vi) TIA 12-6 to NFPA 99, issued March 3, 2014. (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011; (viii) TIA 12-1 to NFPA 101, issued August 11, 2011. (ix) TIA 12-2 to NFPA 101, issued October 30, 2012. (x) TIA 12-3 to NFPA 101, issued October 22, 2013. (xi) TIA 12-4 to NFPA 101, issued October 22, 2013. (2) [Reserved] [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; 71 FR 55339, Sept. 22, 2006; 77 FR 29030, May 16, 2012; 81 FR 26896, May 4, 2016; 81 FR 42548, June 30, 2016] § 416.45 Condition for coverage—Medical staff. The medical staff of the ASC must be accountable to the governing body. (a) Standard: Membership and clinical privileges. (b) Standard: Reappraisals. (c) Standard: Other practitioners. § 416.46 Condition for coverage—Nursing services. 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. (b) [Reserved] § 416.47 Condition for coverage—Medical records. The ASC must maintain complete, comprehensive, and accurate medical records to ensure adequate patient care. (a) Standard: Organization. (b) Standard: Form and content of record. (1) Patient identification. (2) Significant medical history and results of physical examination (as applicable). (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. [47 FR 34094, Aug. 5, 1982, as amended at 84 FR 51814, Sept. 30, 2019] § 416.48 Condition for coverage—Pharmaceutical services. 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. (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] § 416.49 Condition for coverage—Laboratory and radiologic services. (a) Standard: Laboratory services. (b) Standard: Radiologic services. (2) If radiologic services are utilized, the governing body must appoint an individual qualified in accordance with State law and ASC policies who is responsible for assuring all radiologic services are provided in accordance with the requirements of this section. [73 FR 68812, Nov. 18, 2008, as amended at 79 FR 27153, May 12, 2014] § 416.50 Condition for coverage—Patient rights. The ASC must inform the patient or the patient's representative or surrogate of the patient's rights and must protect and promote the exercise of these rights, as set forth in this section. The ASC must also post the written notice of patient rights in a place or places within the ASC likely to be noticed by patients waiting for treatment or by the patient's representative or surrogate, if applicable. (a) Standard: Notice of Rights. (b) Standard: Disclosure of physician financial interest or ownership. (c) Standard: Advance directives. (1) Provide the patient or, as appropriate, the patient's representative with written information concerning its policies on advance directives, including a description of applicable State health and safety laws and, if requested, official State advance directive forms. (2) Inform the patient or, as appropriate, the patient's representative of the patient's right to make informed decisions regarding the patient's care. (3) Document in a prominent part of the patient's current medical record, whether or not the individual has executed an advance directive. (d) Standard: Submission and investigation of grievances. (1) All alleged violations/grievances relating, but not limited to, mistreatment, neglect, verbal, mental, sexual, or physical abuse, must be fully documented. (2) All allegations must be immediately reported to a person in authority in the ASC. (3) Only substantiated allegations must be reported to the State authority or the local authority, or both. (4) The grievance process must specify timeframes for review of the grievance and the provisions of a response. (5) The ASC, in responding to the grievance, must investigate all grievances made by a patient, the patient's representative, or the patient's surrogate regarding treatment or care that is (or fails to be) furnished. (6) The ASC must document how the grievance was addressed, as well as provide the patient, the patient's representative, or the patient's surrogate with written notice of its decision. The decision must contain the name of an ASC contact person, the steps taken to investigate the grievance, the result of the grievance process and the date the grievance process was completed. (e) Standard: Exercise of rights and respect for property and person. (i) Be free from any act of discrimination or reprisal. (ii) Voice grievances regarding treatment or care that is (or fails to be) provided. (iii) Be fully informed about a treatment or procedure and the expected outcome before it is performed. (2) If a patient is adjudged incompetent under applicable State laws by a court of proper jurisdiction, the rights of the patient are exercised by the person appointed under State law to act on the patient's behalf. (3) If a State court has not adjudged a patient incompetent, any legal representative or surrogate designated by the patient in accordance with State law may exercise the patient's rights to the extent allowed by State law. (f) Standard: Privacy and safety. (1) Personal privacy. (2) Receive care in a safe setting. (3) Be free from all forms of abuse or harassment. (g) Standard: Confidentiality of clinical records. [73 FR 68812, Nov. 18, 2008, as amended at 76 FR 65889, Oct. 24, 2011] § 416.51 Conditions for coverage—Infection control. The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases. (a) Standard: Sanitary environment. (b) Standard: Infection control program. (1) Under the direction of a designated and qualified professional who has training in infection control; (2) An integral part of the ASC's quality assessment and performance improvement program; and (3) Responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement. [73 FR 68813, Nov. 18, 2008, as amended at 86 FR 61616, Nov. 5, 2021; 88 FR 36510, June 5, 2023] § 416.52 Conditions for coverage—Patient admission, assessment and discharge. The ASC must ensure each patient has the appropriate pre-surgical and post-surgical assessments completed and that all elements of the discharge requirements are completed. (a) Standard: Patient assessment and admission. (i) Include the timeframe for medical history and physical examination to be completed prior to surgery. (ii) Address, but is not limited to, the following factors: Patient age, diagnosis, the type and number of procedures scheduled to be performed on the same surgery date, known comorbidities, and the planned anesthesia level. (iii) Be based on any applicable nationally recognized standards of practice and guidelines, and any applicable State and local health and safety laws. (2) Upon admission, each patient must have a pre-surgical assessment completed by a physician who will be performing the surgery or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy. (3) The pre-surgical assessment must include documentation of any allergies to drugs and biologicals. (4) The patient's medical history and physical examination (if any) must be placed in the patient's medical record prior to the surgical procedure. (b) Standard: Post-surgical assessment. (2) Post-surgical needs must be addressed and included in the discharge notes. (c) Standard: Discharge. (1) Provide each patient with written discharge instructions and overnight supplies. When appropriate, make a followup appointment with the physician, and ensure that all patients are informed, either in advance of their surgical procedure or prior to leaving the ASC, of their prescriptions, post-operative instructions and physician contact information for followup care. (2) Ensure each patient has a discharge order, signed by the physician who performed the surgery or procedure in accordance with applicable State health and safety laws, standards of practice, and ASC policy. (3) Ensure all patients are discharged in the company of a responsible adult, except those patients exempted by the attending physician. [73 FR 68813, Nov. 18, 2008, as amended at 84 FR 51814, Sept. 30, 2019] § 416.54 Condition for coverage—Emergency preparedness. The Ambulatory Surgical Center (ASC) must comply with all applicable Federal, State, and local emergency preparedness requirements. The ASC must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency plan. (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment. (3) Address patient population, including, but not limited to, the type of services the ASC has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. (b) Policies and procedures. (1) A system to track the location of on-duty staff and sheltered patients in the ASC's care during an emergency. If on-duty staff or sheltered patients are relocated during the emergency, the ASC must document the specific name and location of the receiving facility or other location. (2) Safe evacuation from the ASC, which includes the following: (i) Consideration of care and treatment needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. (3) A means to shelter in place for patients, staff, and volunteers who remain in the ASC. (4) A system of medical documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. (5) The use of volunteers in an emergency and other staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. (6) The role of the ASC under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials. (c) Communication plan. (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. (2) Contact information for the following: (i) Federal, State, tribal, regional, and local emergency preparedness staff. (ii) Other sources of assistance. (3) Primary and alternate means for communicating with the following: (i) ASC's staff. (ii) Federal, State, tribal, regional, and local emergency management agencies. (4) A method for sharing information and medical documentation for patients under the ASC's care, as necessary, with other health care providers to maintain the continuity of care. (5) A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii). (6) A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4). (7) A means of providing information about the ASC's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee. (d) Training and testing. (1) Training program. (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the ASC must conduct training on the updated policies and procedures. (2) Testing. (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the ASC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ASC is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based, or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ASC's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the ASC's emergency plan, as needed. (e) Integrated healthcare systems. (1) Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program. (2) Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered. (3) Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance. (4) Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following: (i) A documented community-based risk assessment, utilizing an all-hazards approach. (ii) A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach. (5) Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively. [81 FR 64022, Sept. 16, 2016, as amended at 84 FR 51814, Sept. 30, 2019] Subpart D—Scope of Benefits for Services Furnished Before January 1, 2008 § 416.60 General rules. (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] § 416.61 Scope of facility services. (a) Included services. (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. [56 FR 8844, Mar. 1, 1991, as amended at 57 FR 33899, July 31, 1992] § 416.65 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 with paragraph (c) of this section. (a) General standards. (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 § 411.15 of this chapter. (b) Specific standards. (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. Federal Register [47 FR 34094, Aug. 5, 1982, as amended at 71 FR 68226, Nov. 24, 2006] § 416.75 Performance of listed surgical procedures on an inpatient hospital basis. 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. § 416.76 Applicability. The provisions of this subpart apply to facility services furnished before January 1, 2008. [71 FR 68226, Nov. 24, 2006] Subpart E—Prospective Payment System for Facility Services Furnished Before January 1, 2008 § 416.120 Basis for payment. The basis for payment depends on where the services are furnished. (a) Hospital outpatient department. (b) [Reserved] (c) ASC General rule. (2) Single and multiple surgical procedures. (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. [56 FR 8844, Mar. 1, 1991; 56 FR 23022, May 20, 1991, as amended at 71 FR 68226, Nov. 24, 2006] § 416.121 Applicability. The provisions of this subpart apply to facility services furnished before January 1, 2008. [71 FR 68226, Nov. 24, 2006] § 416.125 ASC facility services payment rate. (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. (c) For services furnished on or after January 1, 2007, and before the effective date of implementation of a revised payment system, the ASC payment rate for a surgical procedure is the lesser of the ASC payment rate established under paragraph (a) of this section or the prospective payment rate for the procedure established under § 419.32 of this chapter. The lesser payment amount is determined prior to application of any geographic adjustment. [56 FR 8844, Mar. 1, 1991, as amended at 71 FR 68226, Nov. 24, 2006] § 416.130 Publication of revised payment methodologies. Whenever CMS proposes to revise the payment rate for ASCs, CMS publishes a notice in the Federal Register [47 FR 34094, Aug. 5, 1982, as amended at 56 FR 8844, Mar. 1, 1991] § 416.140 Surveys. (a) Timing, purpose, and procedures. (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. (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] Subpart F—Coverage, Scope of ASC Services, and Prospective Payment System for ASC Services Furnished on or After January 1, 2008 Source: 72 FR 42545, Aug. 2, 2007, unless otherwise noted. § 416.160 Basis and scope. (a) Statutory basis. (2) Section 1833(a)(1)(G) of the Act provides that, beginning with the implementation date of a revised payment system for ASC facility services furnished in connection with a surgical procedure pursuant to section 1833(i)(1)(A) of the Act, the amount paid shall be 80 percent of the lesser of the actual charge for such services or the amount determined by the Secretary under the revised payment system. (3) 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 ASC. (4) Section 1834(d) of the Act specifies that, when screening colonoscopies or screening flexible sigmoidoscopies are performed in an ASC or hospital outpatient department, payment shall be based on the lesser of the amount under the fee schedule that would apply to such services if they were performed in a hospital outpatient department in an area or the amount under the fee schedule that would apply to such services if they were performed in an ambulatory surgical center in the same area. Section 1834(d) of the Act also specifies that, in the case of screening flexible sigmoidoscopy and screening colonoscopy services, the payment amounts must not exceed the payment rates established for the related diagnostic services. (5) Section 1833(a)(1) of the Act requires 100 percent payment for preventive services described in section 1861(ww)(2) of the Act (excluding electrocardiograms) to which the United States Preventive Services Task Force (USPSTF) has given a grade of A or B for any indication or population. Section 1833(b)(1) of the Act also specifies that the Part B deductible shall not apply with respect to preventive services described in section 1861(ww)(2) of the Act (excluding electrocardiograms) to which the USPSTF has given a grade of A or B for any indication or population. (b) Scope. (1) The scope of ASC services and the criteria for determining the covered surgical procedures for which Medicare provides payment for the associated facility services and covered ancillary services; (2) The basis of payment for facility services and for covered ancillary services furnished in an ASC in connection with a covered surgical procedure; (3) The methodologies by which Medicare determines payment amounts for ASC services. [72 FR 42545, Aug. 2, 2007, as amended at 75 FR 72264, Nov. 24, 2010; 77 FR 68558, Nov. 15, 2012] § 416.161 Applicability of this subpart. The provisions of this subpart apply to ASC services furnished on or after January 1, 2008. § 416.163 General rules. (a) Payment is made under this subpart for ASC services specified in §§ 416.164(a) and (b) furnished to Medicare beneficiaries by a participating ASC in connection with covered surgical procedures as determined by the Secretary in accordance with § 416.166. (b) Payment for physicians' services and payment for anesthetists' services are made in accordance with part 414 of this subchapter. (c) Payment for items and services other than physicians' and anesthetists' services, as specified in § 416.164(c), is made in accordance with § 410.152 of this subchapter. § 416.164 Scope of ASC services. (a) Included facility services. (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); (5) Medical and surgical supplies not on pass-through status under subpart G of part 419 of this subchapter and not covered ancillary skin substitute supplies under paragraph (b) of this section; (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. (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; (6) Non-opioid pain management drugs, biologicals, and medical devices as determined by CMS under § 416.174; and (7) Groups of skin substitute supply products. (c) Excluded services. (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; 89 FR 94588, Nov. 27, 2024; 90 FR 54084, Nov. 25, 2025] § 416.166 Covered surgical procedures. (a) Covered surgical procedures. (2) Effective for services furnished on or after January 1, 2026, covered surgical procedures are those procedures that meet the requirements described in paragraph (b)(2) of this section (whether commonly furnished in an ASC or a physician's office). (b) Requirements for covered surgical procedures General Standards. Federal Register (2) Effective for services furnished on or after January 1, 2026, covered surgical procedures are surgical procedures specified by the Secretary that are published in the Federal Register (i) Are separately paid under the OPPS; and (ii) Are not: (A) Currently designated as requiring inpatient care under § 419.22(n) of this subchapter; (B) Only able to be reported using a CPT unlisted surgical procedure code; or (C) Otherwise excluded under § 411.15 of this chapter. (c) General exclusions effective January 1, 2008, through December 31, 2025. (1) Generally result in extensive blood loss; (2) Require major or prolonged invasion of body cavities; (3) Directly involve major blood vessels; (4) Are generally emergent or life-threatening in nature; (5) Commonly require systemic thrombolytic therapy; (6) Are designated as requiring inpatient care under § 419.22(n) of this subchapter; (7) Can only be reported using a CPT unlisted surgical procedure code; or (8) Are otherwise excluded under § 411.15 of this chapter. (d) Physician considerations beginning January 1, 2026. (1) Is not expected to pose a significant safety risk when performed in an ASC; (2) Is one of which standard medical practice dictates the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure; (3) Generally results in extensive blood loss; (4) Requires major or prolonged invasion of body cavities; (5) Directly involves major blood vessels; (6) Is generally emergent or life-threatening in nature; and (7) commonly requires systemic thrombolytic therapy. (e) Additions to the list of ASC covered surgical procedures beginning January 1, 2026. (1) CMS identifies a surgical procedure that meets the requirements at paragraph (b)(2) of this section. (2) CMS is notified of a surgical procedure that could meet the requirements at paragraph (b)(2) of this section and CMS confirms that such surgical procedure meets those requirements. [90 FR 54084, Nov. 25, 2025] § 416.167 Basis of payment. (a) Unit of payment. (b) Ambulatory payment classification (APC) groups and payment weights. (2) For purposes of calculating ASC national payment rates under the methodology described in § 416.171, except as specified in paragraph (b)(3) of this section, an ASC relative payment weight is determined based on the APC relative payment weight for each covered surgical procedure and covered ancillary service that has an applicable APC relative payment weight described in § 419.31 of this subchapter. (3) Notwithstanding paragraph (b)(2) of this section, the relative payment weights for services paid in accordance with § 416.171(d) are determined so that the national ASC payment rate does not exceed the unadjusted nonfacility practice expense amount paid under the Medicare physician fee schedule for such procedures under subpart B of part 414 of this subchapter. § 416.171 Determination of payment rates for ASC services. (a) Standard methodology. (1) Conversion factor for CY 2008. (2) Conversion factor for CY 2009 and subsequent calendar years. (i) For CY 2009, the update is equal to zero percent. (ii) For CY 2010 through CY 2018, the update is the Consumer Price Index for All Urban Consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved. (iii) For CY 2019 through CY 2026, the update is the hospital inpatient market basket percentage increase applicable under section 1886(b)(3)(B)(iii) of the Act. (iv) For CY 2027 and subsequent years, the update is the Consumer Price Index for All Urban Consumers (U.S. city average) as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved. (v) For CY 2014 through CY 2018, the Consumer Price Index for All Urban Consumers update determined under paragraph (a)(2)(ii) of this section was reduced by 2.0 percentage points for ASCs that failed to meet the standards for reporting of ASC quality measures as established by the Secretary for the corresponding calendar year. (vi) For CY 2019 through CY 2026, the hospital inpatient market basket percentage increase determined under paragraph (a)(2)(iii) of this section is reduced by 2.0 percentage points for an ASC that fails to meet the standards for reporting of ASC quality measures as established by the Secretary for the corresponding calendar year. (vii) For CY 2027 and subsequent years, the Consumer Price Index for All Urban Consumers update determined under paragraph (a)(2)(iv) of this section is reduced by 2.0 percentage points for an ASC that fails to meet the standards for reporting of ASC quality measures as established by the Secretary for the corresponding calendar year. (viii)(A) For CY 2011 through CY 2018, the Consumer Price Index for All Urban Consumers determined under paragraph (a)(2)(ii) of this section, after application of any reduction under paragraph (a)(2)(iv) of this section, was reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. (B) For CY 2019 through CY 2026, the hospital inpatient market basket percentage increase determined under paragraph (a)(2)(iii) of this section, after application of any reduction under paragraph (a)(2)(v) of this section, is reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. (C) For CY 2027 and subsequent years, the Consumer Price Index for All Urban Consumers determined under paragraph (a)(2)(iv) of this section, after application of any reduction under paragraph (a)(2)(vii) of this section, is reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. (b) Exception. Federal Register (1) Covered ancillary services specified in § 416.164(b), with the exception of radiology services and certain diagnostic tests as provided in § 416.164(b)(5) and non-opioid pain management drugs, biologicals, and medical devices as determined by CMS under § 416.174. (2) The device portion of device-intensive procedures, which are procedures that— (i) Involve implantable devices assigned a CPT or HCPCS code; (ii) Utilize devices (including single-use devices) that must be surgically inserted or implanted; and (iii) Have a HCPCS code-level device offset of greater than 30 percent when calculated according to the standard OPPS ASC ratesetting methodology. (3) Procedures using certain separately paid implantable devices that are approved for transitional pass-through payment in accordance with § 419.66 of this subchapter. (4) Notwithstanding paragraph (b)(2) of this section, procedures assigned to Low Volume APCs where the otherwise applicable payment rate calculated based on the standard methodology for such procedures described in paragraph (b) of this section would exceed the payment rate for the equivalent service set under the payment system established under part 419 of this chapter, for which the payment rate will be set at an amount equal to the amount under that payment system. (c) Transitional payment rates. (2) ASC payment rates for CY 2009 are a transitional blend of 50 percent of the CY 2007 ASC payment rate for a covered surgical procedure on the CY 2007 ASC list of surgical procedures and 50 percent of the payment rate for the procedure calculated under the methodology described in paragraph (a) of this section. (3) ASC payment rates for CY 2010 are a transitional blend of 25 percent of the CY 2007 ASC payment rate for a covered surgical procedure on the CY 2007 ASC list of surgical procedures and 75 percent of the payment rate for the procedure calculated under the methodology described in paragraph (a) of this section. (4) The national ASC payment rate for CY 2011 and subsequent calendar years for a covered surgical procedure designated in accordance with § 416.166 is the payment rates for the procedure calculated under the methodology described in paragraph (a) of this section. (5) Covered ancillary services described in § 416.164(b) and surgical procedures identified as covered when performed in an ASC under § 416.166 for the first time beginning on or after January 1, 2008, are not subject to the transitional payment rates applicable in CYs 2008 through 2010 for ASC facility services. (d) Limitation on payment rates for office-based surgical procedures and covered ancillary radiology services and certain diagnostic tests. (1) The national unadjusted ASC payment rate for covered ancillary radiology services that involve certain nuclear medicine procedures will be the amount determined under paragraph (a) of this section. (2) The national unadjusted ASC payment rate for covered ancillary radiology services that use contrast agents will be the amount determined under paragraph (a) of this section. (e) Budget neutrality. (2) For CY 2009 and subsequent calendar years, CMS adjusts the ASC relative payment weights under § 416.167(b)(2) as needed so that any updates and adjustments made under § 419.50(a) of this subchapter are budget neutral as estimated by CMS. [72 FR 42545, Aug. 2, 2007, as amended at 75 FR 72264, Nov. 24, 2010; 76 FR 74582, Nov. 30, 2011; 77 FR 277, Jan. 4, 2012; 77 FR 68558, Nov. 15, 2012; 79 FR 67030, Nov. 10, 2014; 81 FR 79879, Nov. 14, 2016; 83 FR 59178, Nov. 21, 2018; 84 FR 61490, Nov. 12, 2019; 86 FR 63993, Nov. 16, 2021; 88 FR 82179, Nov. 22, 2023; 89 FR 94588, Nov. 27, 2024; 90 FR 54085, Nov. 25, 2025] § 416.172 Adjustments to national payment rates. (a) General rule. (b) Lesser of actual charge or geographically adjusted payment rate. (1) The actual charge for the service; or (2) The geographically adjusted payment rate determined under this subpart. (c) Geographic adjustment General rule. (2) Exception. (d) Deductibles and coinsurance. (e) Payment reductions for multiple surgical procedures General rule. (i) 100 percent of the applicable ASC payment amount for the procedure with the highest national unadjusted ASC payment rate; and (ii) 50 percent of the applicable ASC payment amount for all other covered surgical procedures. (2) Exception: Procedures not subject to multiple procedure discounting. (f) Interrupted procedures. (i) The full program and beneficiary coinsurance amounts if the procedure for which anesthesia is planned is discontinued after the induction of anesthesia or after the procedure is started; (ii) One-half of the full program and beneficiary coinsurance amounts if the procedure for which anesthesia is planned is discontinued after the patient is prepared for surgery and taken to the room where the procedure is to be performed but before the anesthesia is induced; or (iii) One-half of the full program and beneficiary coinsurance amounts if a covered surgical procedure or covered ancillary service for which anesthesia is not planned is discontinued after the patient is prepared and taken to the room where the service is to be provided. (2) Beginning CY 2016, if the covered surgical procedure is a device-intensive procedure, the full device portion of the ASC device-intensive procedure is removed prior to determining the Medicare program payment amount and the beneficiary coinsurance amount identified in paragraph (f)(1)(ii) of this section. (g) Payment adjustment for new technology intraocular lenses (NTIOLs). (h) Special payment for certain code combinations Eligibility. (i) Eligible for a comprehensive APC (C-APC) complexity adjustment under the OPPS; and (ii) Comprised of a separately payable surgical procedure, that is listed on the ASC Covered Procedures list (§ 416.166), and one or more packaged add-on codes that are listed on the ASC covered procedures or ancillary services lists (§ 416.164(b)). (2) Calculation of payment. (ii) For primary procedures assigned device-intensive status that are a component of a code combination that is eligible for payment under paragraph (h)(2) of this section, the primary procedure of the code combination retains its device-intensive status, and— (A) The device portion is equivalent to the device portion of the device-intensive APC under the OPPS (§ 419.44(b) of this subchapter); and (B) The non-device portion is calculated in accordance with the methodology specified in § 416.171(a). [72 FR 42545, Aug. 2, 2007, as amended at 80 FR 70604, Nov. 13, 2015; 87 FR 72291, Nov. 23, 2022; 88 FR 82179, Nov. 22, 2023] § 416.173 Publication of revised payment methodologies and payment rates. CMS publishes annually, through notice and comment rulemaking in the Federal Register [76 FR 74582, Nov. 30, 2011] § 416.174 Payment for non-opioid pain management drugs, biologicals, and medical devices. (a) Eligibility for separate payment for non-opioid pain management drugs and biologicals. (1) The drug is approved under a new drug application under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA), under an abbreviated new drug application under section 505(j) of the FDCA, or, in the case of a biological product, is licensed under section 351 of the Public Health Service Act. The product also has a label indication approved by the Food and Drug Administration to reduce postoperative pain, or produce postsurgical or regional analgesia, without acting upon the body's opioid receptors. (2) The drug or biological does not have transitional pass-through payment status under § 419.64 of this subchapter. In the case where a drug or biological otherwise meets the requirements under this section and has transitional pass-through payment status that expires during the calendar year, the drug or biological will qualify for separate payment as specified in this paragraph (a) during such calendar year on the first day of the next quarter following the expiration of its pass-through status. (3) The drug or biological has payment that is packaged into a payment for a covered outpatient department (OPD) service (or group of services) under a policy in this part. (b) Eligibility for separate payment for non-opioid medical devices. (1) The medical device is used to deliver a therapy to reduce postoperative pain, or produce postsurgical or regional analgesia, and has an application under section 515 of the FDCA that has been approved with respect to the device, has been cleared for market under section 510(k) of the FDCA, or is exempt from the requirements of section 510(k) of the FDCA pursuant to section 510(l) or (m) or 520(g) of the FDCA. (2) The medical device has demonstrated the ability to replace, reduce, or avoid intraoperative or postoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal. (3) The medical device does not have transitional pass-through payment status under § 419.66 of this subchapter. In the case where a medical device otherwise meets the requirements under this section and has transitional pass-through payment status that expires during the calendar year, the medical device will qualify for separate payment as specified in this paragraph (b) during such calendar year on the first day of the next calendar year quarter following the expiration of its pass-through status. (4) The medical device has payment that is packaged into a payment for a covered OPD service (or group of services) under a policy in this part. (c) Payment amount. (1) For a qualifying drug or biological as defined in paragraph (a) of this section, the amount of payment is the amount determined under section 1847A of the Act for the drug or biological that exceeds the portion of the otherwise applicable Medicare OPD fee schedule amount, subject to paragraph (c)(3) of this section. (2) For a qualifying medical device as defined in paragraph (b) of this section, the amount of payment is the amount of the hospital's charges for the device, adjusted to cost, that exceeds the portion of the otherwise applicable Medicare OPD fee schedule amount, subject to paragraph (c)(3) of this section. (3) The payment amounts in paragraphs (c)(1) and (2) of this section shall not exceed the estimated average of 18 percent of the OPD fee schedule amount of the volume weighted average of the most frequent five OPD primary procedures into which a non-opioid treatment for pain relief would be packaged. [89 FR 94588, Nov. 27, 2024, as amended at 90 FR 54085, Nov. 25, 2025] § 416.178 Limitations on administrative and judicial review. There is no administrative or judicial review under section 1869 of the Act, section 1878 of the Act, or otherwise of the following: (a) The classification system; (b) Relative weights; (c) Payment amounts; and (d) Geographic adjustment factors. § 416.179 Payment and coinsurance reduction for devices replaced without cost or when full or partial credit is received. (a) General rule. (1) The device is replaced without cost to the ASC or the beneficiary; (2) The ASC receives full credit for the cost of a replaced device; or (3) The ASC receives partial credit for the cost of a replaced device but only where the amount of the device credit is greater than or equal to 50 percent of the cost of the new replacement device being implanted. (b) Amount of reduction to the ASC payment for the covered surgical procedure. (2) The amount of the reduction to the ASC payment made under paragraph (a)(3) of this section is 50 percent of the payment reduction that would be calculated under paragraph (b)(1) of this section. (c) Amount of beneficiary coinsurance. [72 FR 42545, Aug. 2, 2007, as amended at 72 FR 66932, No. 27, 2007] Subpart G—Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Service Centers Source: 71 FR 68226, Nov. 24, 2006, unless otherwise noted. § 416.180 Basis and scope. (a) Basis. (b) Scope. (1) The process for interested parties to request that CMS review the appropriateness of the ASC facility fee for insertion of an IOL. This process includes a review of whether that payment is reasonable and related to the cost of acquiring a lens determined by CMS as belonging to a class of new technology IOLs; (2) Factors that CMS considers for determination of a new class of new technology IOLs; and (3) Application of the payment adjustment. § 416.185 Process for establishing a new class of new technology IOLs. (a) Announcement of deadline for requests for review. (b) Announcement of new classes of new technology IOLs for which review requests have been made and solicitation of public comments. (c) Announcement of determinations regarding requests for review. § 416.190 Request for review of payment amount. (a) When requests can be submitted. (b) Who may submit a request. (c) Content of a request. (d) Confidential information. § 416.195 Determination of membership in new classes of new technology IOLs. (a) Factors to be considered. (1) The IOL is considered new. CMS will evaluate an application for a new technology IOL only if the IOL type has received initial FDA premarket approval within the 3 years prior to the new technology IOL application submission date. (2) The IOL shall have a new lens characteristic in comparison to currently available IOLs. The labeling, which must be approved by FDA, shall contain a claim of a specific clinical benefit imparted by the new lens characteristic. (3) The IOL is not described by an active or expired class of new technology IOLs; that is, it does not share a predominant, class-defining characteristic associated with improved clinical outcomes with members of an active or expired class. (4) Any specific clinical benefit referred to in paragraph (a)(2) of this section must be supported by evidence that demonstrates that the IOL results in a measurable, clinically meaningful, improved outcome. Improved outcomes include: (i) Reduced risk of intraoperative or postoperative complication or trauma; (ii) Accelerated postoperative recovery; (iii) Reduced induced astigmatism; (iv) Improved postoperative visual acuity; (v) More stable postoperative vision; (vi) Other comparable clinical advantages. (b) CMS determination of eligibility for payment adjustment. (1) The IOL is eligible for a payment adjustment as a member of a new class of new technology IOLs. (2) The IOL is a member of an active class of new technology IOLs and is eligible for a payment adjustment for the remainder of the period established for that class. (3) The IOL does not meet the criteria for designation as a new technology IOL and a payment adjustment is not appropriate. [71 FR 68226, Nov. 24, 2006, as amended at 77 FR 68558, Nov. 15, 2012; 80 FR 70604, Nov. 13, 2015] § 416.200 Payment adjustment. (a) CMS establishes the amount of the payment adjustment for classes of new technology IOLs through proposed and final rulemaking in connection with ASC facility services. (b) CMS adjusts the payment for insertion of an IOL approved as belonging to a class of new technology IOLs for the 5-year period of time established for that class. (c) Upon expiration of the 5-year period of the payment adjustment, payment reverts to the standard rate for IOL insertion procedures performed in ASCs. (d) ASCs that furnish an IOL designated by CMS as belonging to a class of new technology IOLs must submit claims using billing codes specified by CMS to receive the new technology IOL payment adjustment. Subpart H—Requirements Under the Ambulatory Surgical Center Quality Reporting (ASCQR) Program Source: 80 FR 70604, Nov. 13, 2015, unless otherwise noted. § 416.300 Basis and scope of subpart. (a) Statutory basis. (b) Scope. § 416.305 Participation and withdrawal requirements under the ASCQR Program. (a) Participation in the ASCQR Program. (b) Withdrawal from the ASCQR Program (2) An ASC may withdraw from the ASCQR Program any time up to and including August 31 of the year preceding a payment determination. (3) Except as provided in paragraph (c) of this section, an ASC will incur a 2.0 percentage point reduction in its ASC annual payment update for that payment determination year and any subsequent payment determinations in which it is withdrawn. (4) An ASC will be considered as rejoining the ASCQR Program if it begins to submit any quality measure data again to the ASCQR Program. (c) Minimum case volume for program participation (d) Indian Health Service hospital outpatient department participation [80 FR 70604, Nov. 13, 2015, as amended at 88 FR 82179, Nov. 22, 2023] § 416.310 Data collection and submission requirements under the ASCQR Program. (a) Requirements for claims-based measures using quality data codes (QDCs). (2) The data collection period for claims-based quality measures reported using QDCs is the calendar year 2 years prior to the payment determination year. Only claims for services furnished in each calendar year paid by the Medicare Administrative Contractor (MAC) by April 30 of the following year of the ending data collection period will be included in the data used for the payment determination year. (3) For ASCQR Program purposes, data completeness for claims-based measures using QDCs is determined by comparing the number of Medicare claims (where Medicare is the primary or secondary payer) meeting measure specifications that contain the appropriate QDCs with the number of Medicare claims that meet measure specifications, but do not have the appropriate QDCs on the submitted Medicare claim. The minimum threshold for successful reporting is that at least 50 percent of Medicare claims meeting measure specifications contain the appropriate QDCs. ASCs that meet this minimum threshold are regarded as having provided complete data for the claims-based measures using QDCs for the ASCQR Program. (b) Requirements for claims-based measures not using QDCs. (c) Requirements for data submitted via an online data submission tool Requirements for data submitted via a CMS online data submission tool CMS-designated information system account for web-based measures. (ii) Data collection requirements. (iii) Review and corrections period. (2) Requirements for data submitted via a non-CMS online data submission tool (d) Extraordinary circumstance exception (ECE) General rule. (2) Process for requesting an ECE. (ii) CMS notifies the ASC of its decision on the request, in writing, via email. In the event that CMS grants an ECE to the ASC, the written decision specifies whether the ASC is exempted from one or more reporting requirements or whether CMS has granted the ASC an extension of time to comply with one or more reporting requirements. (3) Authority to Grant an ECE. (i) A systemic problem with a CMS data collection system directly impacted the ability of the ASC to comply with a quality data reporting requirement; or (ii) An extraordinary circumstance has affected an entire region or locale. Any ECE granted under this paragraph (d)(3) specifies whether the affected ASCs are exempted from one or more reporting requirements or whether CMS has granted the ASCs an extension of time to comply with one or more reporting requirements. (e) Requirements for Outpatient and Ambulatory Surgery Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS) Survey. (1) [Reserved] (2) CMS approves an application for an entity to administer the OAS CAHPS survey as a vendor on behalf of one or more ambulatory surgical centers when the applicant has met the Minimum Survey Requirements and Rules of Participation that can be found on the official OAS CAHPS Web site, and agrees to comply with the current survey administration protocols that can be found on the official OAS CAHPS Web site. An entity must be an approved OAS CAHPS Survey vendor in order to administer the OAS CAPHS Survey and submit data to CMS on behalf of one or more ambulatory surgical centers. (f) Data submission deadlines. [80 FR 70604, Nov. 13, 2015, as amended at 81 FR 79879, Nov. 14, 2016; 82 FR 52636, Nov. 13, 2017; 82 FR 59496, Dec. 14, 2017; 85 FR 86302, Dec. 29, 2020; 88 FR 82179, Nov. 22, 2023; 90 FR 54085, Nov. 25, 2025] § 416.315 Public reporting of data under the ASCQR Program. Data that an ASC submitted for the ASCQR Program will be made publicly available on a CMS Web site after providing the ASC an opportunity to review the data to be made public. CMS will publicly display ASC data by the National Provider Identifier (NPI) when data are submitted by the NPI. CMS will publicly display ASC data by the CMS Certification Number (CCN) when data are submitted by the CCNs. § 416.320 Retention and removal of quality measures under the ASCQR Program. (a) General rule for the retention of quality measures. (b) Immediate measure suspension. (c) Removal of quality measures General rule for the removal of quality measures. (2) Factors for consideration of removal of quality measures. (i) Factor 1. (ii) Factor 2. (iii) Factor 3. (iv) Factor 4. (v) Factor 5. (vi) Factor 6. (vii) Factor 7. (viii) Factor 8. (3) Criteria to determine topped-out measures. (i) Statistically indistinguishable performance at the 75th and 90th percentiles (defined as when the difference between the 75th and 90th percentiles for an ASC's measure is within two times the standard error of the full data set); and (ii) A truncated coefficient of variation less than or equal to 0.10. (4) Application of measure removal factors. [80 FR 70604, Nov. 13, 2015, as amended at 83 FR 59178, Nov. 21, 2018; 88 FR 82179, Nov. 22, 2023; 89 FR 94589, Nov. 27, 2024] § 416.325 Measure maintenance under the ASCQR Program. (a) Measure maintenance under the ASCQR Program. (b) Substantive changes (c) Non-substantive changes. [80 FR 70604, Nov. 13, 2015, as amended at 88 FR 82180, Nov. 22, 2023] § 416.330 Reconsiderations under the ASCQR Program. (a) Reconsiderations of ASCQR Program decisions. (b) Requirements for reconsideration requests (1) The ASC CCN and related NPI(s); (2) The name of the ASC; (3) The CMS-identified reason for not meeting the requirements of the ASCQR Program for the affected payment determination year as provided in any CMS notification to the ASC; (4) The ASC's basis for requesting reconsideration. The ASC must identify its specific reason(s) for believing it met the ASCQR Program requirements for the affected payment determination year and should not be subject to the reduced ASC annual payment update; (5) The ASC-designated personnel contact information, including name, email address, telephone number, and mailing address (must include physical mailing address, not just a post office box); and (6) A copy of all materials that the ASC submitted to comply with the requirements of the affected ASCQR Program payment determination year. With regard to information on claims, ASCs are not required to submit copies of all submitted claims, but instead may focus on the specific claims at issue. For these claims, ASCs should submit relevant information, which could include copies of the actual claims at issue. (c) Reconsideration process (1) Provide an email acknowledgement, using the contact information provided in the reconsideration request, notifying the ASC that the request has been received; and (2) Provide a formal response to the ASC contact using the information provided in the reconsideration request notifying the ASC of the outcome of the reconsideration process. (d) Final ASCQR Program payment determination.