In this chapter, the following terms have the meanings indicated. Terms Defined. “Covered surgical procedures” means those surgical and other medical procedures which meet the criteria specified in 42 CFR Part 416, Subpart F, §416.166(a) and (b), and which are published by the Centers for Medicare and Medicaid Services (CMS) in the Federal Register. “Dental Benefits Administrator (DBA)” means an entity that administers the dental program for the Maryland Department of Health. “Dental services” means emergency, preventive, or therapeutic services for oral diseases which are administered by or under the general supervision of a dentist in the practice of the profession. “Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01. “Free-standing Ambulatory Surgery Center (ASC)” means an entity capable of providing ambulatory surgical services, which is not located in a hospital setting, and which is Medicare-certified to furnish ambulatory surgical services. “Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. “Medicare” means Medicare as defined in COMAR 10.09.36.01. “Medicare-certified facility” means a facility which: Is certified for Medicare by the regional office of the Centers for Medicare and Medicaid Services (CMS) to furnish ambulatory surgical services directly to patients; Has an agreement with (CMS) under Medicare to participate as an ASC; and Meets the conditions set forth by (CMS) in 42 CFR Part 416, Subparts B, C, and F, §416.163. “Patient” means a recipient awaiting or undergoing health care or treatment. “Physician” means an individual legally licensed to practice medicine in the state in which the physician's practice is located. “Podiatrist” means a Doctor of Podiatry (D.P.M.) who is licensed to practice podiatry by the Board or by the state in which the service is rendered. “Program” means Program as defined in COMAR 10.09.36. “Provider” means a free-standing ambulatory surgical center which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider account number. “Recipient” means recipient as defined in COMAR 10.09.36.01. License requirements under this chapter are referenced in COMAR 10.09.36.02. The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of the Maryland Radiation Act, Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland, and meets the standards established by COMAR 26.12.01 and COMAR 26.12.02 or other applicable standards established by the state in which the service is provided. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and either COMAR 10.10.01 or 10.10.06, as applicable; or If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03 and 42 CFR, Part 416, Subpart B. Specific requirements for participation in the Program are that the provider shall meet all specific conditions for participation as set forth in 42 CFR, Part 416, Subpart C, to include the following: Be approved by Medicare to furnish ambulatory surgical services to patients and maintain documentation of certification by the Department of Health and Human Services and the Centers for Medicare and Medicaid Services; Have clearly defined, written, patient care policies; Maintain adequate documentation of each recipient visit as part of the plan of care, which at a minimum, shall include: Date of service; Recipient's reason for visit; A brief description of service provided, and A legible signature and printed or typed name of the professional providing care, with the appropriate title; Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01; Be approved by the state in which the service is provided, except where a Certificate of Need is not required; Provide for in-house Program evaluation and clinical record review which assess use of services for appropriateness in meeting a recipient's needs; Refer laboratory testing only to independent medical laboratory providers. The Program covers the following: Medically necessary facility services rendered to recipients in a free-standing Medicare-certified ambulatory surgical center; Diagnostic, curative, palliative, or rehabilitative services, when clearly related to the recipient's individual needs; Surgical procedures which meet the standards described in 42 CFR Part 416, Subpart D, §416.65, and as published by the Centers for Medicare and Medicaid Services; and Dental services that have been pre-authorized by the Dental Benefits Administrator (DBA). The Program does not cover the following: Services not specified in Regulation .04 of this chapter; Services not medically necessary; Investigational and experimental drugs and procedures; Services denied by Medicare as not medically justified; Separate billing of services which are included in the composite Medicare rate for an ambulatory surgical center; Surgical procedures which: Generally result in extensive blood loss; Require major or prolonged invasion of body cavities; Directly involve major blood vessels; Are generally emergency or life-threatening in nature; Commonly require systemic thrombolytic therapy; Are designated as requiring inpatient care (overnight); Can only be reported using a CPT unlisted surgical procedure code; or Are otherwise excluded under 42 CFR §411.15(a)—(h) and (j)—(s); Physicians' services, including surgical procedures and all preoperative and postoperative services performed by a physician; Anesthesia services; Radiology services other than those integral to performance of a covered surgical procedure; Diagnostic procedures other than those directly related to a covered surgical procedure; Ambulance services; Leg, arm, back, and neck braces other than those that serve the function of a cast or splint; Artificial limbs; or Non-implantable prosthetic devices and durable medical equipment (DME). The Program reimburses a facility fee when the free-standing Medicare certified ambulatory surgery center provides a covered surgical procedure, in accordance with 42 CFR §416.166 to an eligible Medicaid recipient. Reimbursement for the facility fee includes, but is not limited to the following: Nursing, technician, and related services; Use of the facility; Drugs, biologicals, surgical dressings, supplies, splints, casts, and appliances, and any equipment directly related to the provision of surgical procedures; Administrative costs; Materials including supplies and equipment for the administration and monitoring of anesthesia; Radiology services for which separate payment is not allowed and other diagnostic tests or interpretive services that are integral to a surgical procedure; Supervision of the services of a nurse anesthetist by the operating surgeon; Ancillary items and services that are integral to a covered surgical procedure as defined in 42 CFR §416.166; and Any laboratory testing performed under a Clinical Laboratory Improvement Amendment of 1988 (CLIA) certificate of waiver. Reimbursement Methodology: Reimbursement fees equal 80 percent of the current Medicare-approved ASC facility fee for services furnished to Medicaid recipients in connection with covered surgical procedures. If one covered surgical procedure is furnished to a recipient, payment is at the Maryland Medicaid Program payment amount which is 80 percent of the current Medicare approved facility fee for that procedure. If more than one covered surgical procedure is provided to a recipient in a single operative session, payment is made at 100 percent of the Maryland Medicaid Program payment amount for the procedure with the highest reimbursement rate. Other covered surgical procedures furnished during the same session are reimbursed at 50 percent of the Maryland Medicaid Program payment amount for each procedure. When a covered surgical procedure is terminated before the completion due to extenuating circumstances or circumstances that threaten the well-being of the patient, the Medicaid Program payment amount is based on one of the following: If the covered procedure for which the anesthesia is planned is discontinued after the induction of anesthesia or after the procedure is started, the reimbursement amount is 80 percent of the current Medicare approved facility fee; or If the patient is prepared for surgery and the surgery is then cancelled before the induction of anesthesia, reimbursement shall be 50 percent of Maryland Medicaid payment amount. Dental services rendered in an ASC on or after December 1, 2014, shall be reimbursed as follows: For covered dental services that have a reimbursement amount of $1,000 through $2,999.99, the ASC facility fee will be $600; For covered dental services that have a reimbursement amount of $3,000 through $4,999.99, the ASC facility fee will be $1,250; For covered dental services that have a reimbursement amount of $5,000 through $7,999.99, the ASC facility fee will be $2,500; and For covered dental services that have a reimbursement amount of $8,000 and over, the ASC facility fee will be $3,000. The provider shall submit a request for payment as set forth in COMAR 10.09.36.04A. The Program reserves the right to return to the provider, before payment, all invoices not properly completed, including but not limited to, diagnostic and procedure codes and description of services provided. The Program shall authorize payment on Medicare cross-over claims only if: The provider accepts Medicare assignment; Medicare makes direct payment to the provider; and Medicare has determined that the services are medically justified, excludes dental services. The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions: Deductible is paid in full; Coinsurance shall be paid lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare, but considered medically necessary by the Program, according to the limitations of Regulation .04C of this chapter. The provider may not bill the Program for: Completion of forms and reports; Broken or missed appointments; Professional services rendered by mail or telephone; or Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient. The Program shall make no direct payment to a recipient. The Program shall make no separate direct payment to any person employed by or under contract to any free-standing Medicare-certified ambulatory surgical center facility for services covered under this regulation. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. Recovery and reimbursement under this chapter are set forth in COMAR 10.09.36.07. Causes for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08. Appeal procedures under this chapter are set forth in COMAR 10.09.36.09. Interpretive regulations under this chapter are set forth in COMAR 10.09.36.10. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: September 2, 1991 (18:17 Md. R. 1918) Regulation .01B amended effective September 29, 2003 (30:19 Md. R. 1332); April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485) Regulation .02B amended effective March 16, 2015 (42:5 Md. R. 485) Regulation .02C amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) Regulation .03 amended effective March 16, 2015 (42:5 Md. R. 485) Regulation .03B amended effective April 5, 2010 (37:7 Md. R. 571) Regulation .04C amended effective September 29, 2003 (30:19 Md. R. 1332); April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485) Regulation .04D adopted effective March 16, 2015 (42:5 Md. R. 485) Regulation .05 amended effective April 5, 2010 (37:7 Md. R. 571) Regulation .05F amended effective March 16, 2015 (42:5 Md. R. 485) Regulation .06 amended effective April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485) Regulation .06B amended effective April 12, 2004 (31:7 Md. R. 584) Regulation .06H amended effective July 4, 2016 (43:13 Md. R. 712)