Chapter 5160-11 Independent Laboratory and X-Ray Services

5160-11-01 Definitions: independent laboratory, portable x-ray supplier, independent diagnostic testing facility (IDTF), and mammography supplier.

(A) "Independent laboratory" means a facility established for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials of the human body for the purpose of obtaining information for the diagnosis, prevention, or treatment of any disease or impairment of, or for the assessment of the health of, human beings. It is independent of an attending or consulting physician's office or group practice, a clinic, an ambulatory surgery center, or a hospital. A laboratory under the ownership and direction of a physician or physician group is considered to be an independent laboratory if it is represented to other physicians that both the physician-owner(s)/director(s) and the facility are available for the performance of laboratory procedures. Facilities that only collect or prepare specimens or that function only as a mailing service and do not perform testing are not considered to be laboratories.

(B) "Portable x-ray supplier" means an entity established for the provision of diagnostic x-ray services in a consumer's place of residence.

(C) "Independent diagnostic testing facility (IDTF)" means a facility or an entity established for the performance of diagnostic tests that are conducted by licensed or certified nonphysician personnel under appropriate physician supervision. An IDTF may be a fixed location, a mobile entity, or an individual nonphysician practitioner. It is independent of an attending or consulting physician's office or group practice, a clinic, an ambulatory surgery center, or a hospital. A diagnostic testing facility under the ownership and direction of a physician or physician group is considered to be an independent diagnostic testing facility if it is represented to other physicians that both the physician-owner(s)/director(s) and the facility are available for the performance of diagnostic tests.

(D) "Mammography supplier" means a facility or an entity established solely for the provision of mammography services. For billing and payment purposes within the Ohio medicaid program, a mammography supplier is treated as an independent diagnostic testing facility.

Effective: 06/01/2009
R.C. 119.032 review dates: 05/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 04/07/1977, 05/09/1986, 02/17/1991, 07/01/1993, 08/01/2001, 05/25/2006

5160-11-02 Provider requirements: independent laboratory, portable x-ray supplier, independent diagnostic testing facility (IDTF), mammography supplier, and other providers of laboratory services.

(A) General requirements for participation.

(1) An entity is eligible to participate in the medicaid program as an independent laboratory, a portable x-ray supplier, or an independent diagnostic testing facility (IDTF) and to provide covered services if it satisfies the following requirements:

(a) It must conform to the appropriate definition set forth in rule 5101:3-11-01 of the Administrative Code;

(b) It must have executed the standard Ohio medicaid provider agreement in accordance with rule 5101:3-1-17.2 of the Administrative Code; and

(c) It must comply with all applicable state laws.

(2) Any eligible medicaid provider included in the following list or otherwise certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) may provide and be reimbursed for covered laboratory procedures appropriate to its level of certification.

(a) Ambulatory health care clinic;

(b) Ambulatory surgery center (ASC);

(c) Federally qualified health center (FQHC);

(d) Outpatient health facility (OHF);

(e) Outpatient hospital laboratory;

(f) Physician or physician group practice;

(g) Podiatrist or podiatric group practice; or

(h) Rural health clinic (RHC).

(B) Specific requirements for reimbursement.

A participating entity is eligible for reimbursement if it satisfies additional requirements.

(1) An independent laboratory must meet the following criteria:

(a) It must meet the standards of compliance listed at 42 C.F.R. 493.3 (effective April 24, 2003).

(b) It must perform covered procedures that are appropriate to its level of certification.

(i) A provider possessing only a certificate of waiver may be reimbursed only for waived procedures.

(ii) A provider possessing only a certificate for provider-performed microscopy (PPM) procedures may be reimbursed only for waived and PPM procedures.

(iii) A provider possessing a certificate of registration, a certificate of compliance, or a certificate of accreditation may be reimbursed for:

(a) Waived procedures;

(b) PPM procedures;

(c) Tests of moderate complexity, if the provider meets the applicable requirements set forth in 42 C.F.R. 493.20 (effective September 22, 2003); and

(d) Tests of high complexity, if the provider meets the applicable requirements set forth in 42 C.F.R. 493.25 (effective September 22, 2003).

(2) A portable x-ray supplier must comply with the conditions for coverage set forth in 42 C.F.R. part 486, subpart C (sections 486.100, 486.102, 486.104, 486.106, and 486.108 effective February 8, 1995; section 486.110 effective September 29, 1995).

(3) An independent diagnostic testing facility (IDTF) must meet the following criteria:

(a) It must meet all standards set forth in and provide services in accordance with 42 C.F.R. 410.33 (effective January 15, 2008).

(b) It must be a party to a current, unrevoked, and unsuspended agreement to participate in medicare as an independent diagnostic testing facility (IDTF).

(c) It must take the following measures to establish accountability:

(i) It must ensure that each supervising physician certifies in writing, at the time of the initial application and at each renewal of the Ohio medicaid provider agreement, that one of two statements is true:

(a) The physician owns the facility, in whole or in part, and employs the operating personnel; or

(b) The physician is an employee of the facility (full-time, part-time, or under contract) whose responsibilities include checking the procedure and quality control manuals; observing the performance of operators or technicians; verifying that the equipment and personnel meet applicable federal, state, and local licensure and registration requirements; and ensuring that safe operating procedures and quality control procedures are used.

(ii) It must maintain and update procedure and quality control manuals. All records of quality control must be kept for the period of time specified in paragraph (D) of rule 5101:3-1-17.2 of the Administrative Code.

(4) A mammography supplier must meet the following criteria:

(a) It must participate in the medicaid program as an independent diagnostic testing facility (IDTF).

(b) It must comply with the conditions for coverage set forth in 42 C.F.R. 410.34 (effective October 31, 1997).

Replaces: 5101:3-11-02

Effective: 06/01/2009
R.C. 119.032 review dates: 06/01/2014
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 04/07/1977, 09/19/1977, 12/21/1977, 12/30/1977, 10/01/1984 (Emer), 12/30/1984, 05/09/1986, 06/01/1986, 02/17/1991, 09/02/1992 (Emer), 12/01/1992, 04/30/1993 (Emer), 07/01/1993, 08/01/2001, 02/01/2003

5160-11-03 Laboratory services: coverage and limitations.

(A) Laboratory services include:

(1) Biological, microbiological, serological, chemical, immunological, immunohematological, hematological, cytological, or pathological procedures performed on specimens from the human body;

(2) Specimen collections as defined in paragraph (F) of this rule; and

(3) Electrocardiogram (ECG/EKG) services when they are performed by certified independent laboratories.

(B) A laboratory service is covered only if:

(1) The test is medically necessary as defined in rule 5101:3-1-01 of the Administrative Code, or the test is medically indicated when provided in conjunction with a covered preventive health service as defined in rule 5101:3-4-02 of the Administrative Code;

(2) The laboratory which performed the procedure is certified to perform the procedure under the medicare program in accordance with the "Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)"; and

(3) The laboratory service is performed at the written or electronic request of an authorized practitioner.

(a) The laboratory procedure may be performed on the verbal order of a physician but the laboratory must obtain a written order before the department is billed. The laboratory must maintain the written authorization.

(b) A copy of the written order must be kept on file by the laboratory for a period of six years as described in rule 5101:3-1-17.2 of the Administrative Code. When laboratory services are performed by the physician's office, group practice, clinic, or a hospital (for hospital inpatients and outpatients), the orders may be written by an authorized person in the patient's medical records. The patient's medical record, if used as the test requisition, must be retained for a minimum of six years and must be available to the laboratory at the time of testing and available to the department upon request.

(c) The laboratory must assure that the requisition or test authorization includes:

(i) The patient's name;

(ii) The name and address of the authorized person requesting the test, and, if appropriate, the individual responsible for utilizing the test results or the name and address of the laboratory submitting the specimen;

(iii) The test to be performed;

(iv) The date of the specimen collection;

(v) For pap smears, the patient's last menstrual period, age, or date of birth, and indication of whether the patient had a previous abnormal report, treatment, or biopsy; and

(vi) Any additional information necessary to a specific test to assure accurate and timely testing and reporting.

(d) Laboratory tests that must be performed as follow-up to a result of a test that was ordered do not need the written order of a physician as long as the follow-up procedure meets standard and appropriate laboratory practices and is included as part of the laboratory's written protocols. For example, an antibody panel and direct coombs performed after a positive antibody screen or a quantitative test performed after a positive qualitative test.

(e) The laboratory which performed the test must meet all laboratory standards outlined in 42 C.F.R. 493 (October 1, 2005).

(C) Except as provided for in rule 5101:3-11-04 of the Administrative Code, providers, including hospitals providing services to hospital outpatients and independent laboratories, may bill the department only for those laboratory procedures they actually perform.

(D) A physician or clinic may be reimbursed only for the following laboratory services:

(1) Clinical pathology procedures and specimen collection actually performed in the physician's office, physician's group practice, or clinic;

(2) The professional component of anatomical pathology procedures;

(3) The total anatomical pathology procedure when the physician operates a full-service, in-office laboratory certified to perform both the technical and professional components, and the services are performed on a nonhospital patient;

(4) Clinical pathology consultative services;

(5) Services performed by a physician in personal administration of test devices, isotopes, or other materials to an individual patient.

(E) Laboratory procedures are divided into two categories: clinical laboratory procedures and anatomical pathology procedures. The department will determine which procedures are considered clinical laboratory procedures and anatomical pathology procedures.

(1) Clinical laboratory procedure codes.

(a) To bill for clinical laboratory procedures, the provider must bill the most appropriate code for the procedure (unmodified). Clinical laboratory codes may not be billed with a modifier.

(b) Providers must use the codes for organ- or disease-oriented panels.

(i) When a laboratory/provider performs all of the tests included in a panel, a panel code must be billed. Providers may not bill separately for each of the tests included in a panel code.

(ii) If a laboratory/provider performs a panel of tests and other tests in addition to those specifically listed as included in the panel code, the additional tests may be billed separately in addition to the panel code.

(iii) When a provider performs some, but not all of the tests identified in a panel, the provider may not bill the panel code but must bill separately for each of the tests performed using the appropriate codes.

(iv) Panels for preventive health screenings are only reimbursable when provided to children under the healthcheck program.

(c) Providers must use the codes for certain organ- or diseased- oriented panels when all the tests listed as included in that panel code are performed.

(d) If a laboratory/provider performs other tests in addition to those specifically listed as included in a panel code, the additional tests may be billed in addition to the panel code. Inclusion of additional tests in a laboratory's/provider's own definition of a panel code does not justify the medical need for the test or the coverage of the test under medicaid.

(e) Providers may not bill nor be reimbursed for clinical laboratory procedures performed on hospital inpatients even if the laboratory procedures were performed by a laboratory outside the hospital. Clinical laboratory procedures performed on hospital inpatients are reimbursed in accordance with paragraph (E) of rule 5101:3-11-08 of the Administrative Code.

(2) Anatomical pathology codes.

(a) For the purpose of the medicaid program, the term "anatomical pathology" has been extended to include all laboratory services which require the total involvement or the partial involvement of a physician in the performance of the procedure.

(b) Anatomical pathology codes can be identified as those codes for which there is a professional/technical indicator in appendix DD of rule 5101:3-1-60 of the Administrative Code.

(c) A professional and technical component is recognized for each anatomical pathology procedure. When both components are provided by one provider, the laboratory service is defined as the total procedure.

(d) When anatomical pathology procedures are performed on a hospital outpatient or a hospital emergency room patient, the hospital must bill for the technical component and the physician, or an eligible provider billing on behalf of the physician, must bill for the professional component of the procedure, even if the services were performed by a laboratory outside the hospital.

(e) When anatomical pathology procedures are furnished to hospital inpatients, the services are covered in accordance with paragraph (E) of rule 5101:3-11-08 of the Administrative Code.

(f) Total procedure.

For services rendered on or after July 1, 2003, the department will no longer recognize the ZP modifier.

(i) The total procedure must be billed when both components of an anatomical pathology procedure are performed by a nonhospital provider. Neither hospitals nor hospital-based physicians may bill for the total anatomical pathology procedure.

(ii) For services rendered on or after July 1, 2003, reimbursement for the total anatomical pathology procedure will be the lesser of the provider's total charged amount or the medicaid maximum for the appropriate code.

(iii) For services rendered prior to July 1, 2003, reimbursement of the total procedure will be made when providers bill the most appropriate code for the anatomical pathology procedure modified by the modifier ZP (e.g., 88300ZP)

(g) Professional component.

(i) The professional component recognized by the department for an anatomical pathology procedure is for the professional services a physician renders in the performance of the laboratory procedure and not for the interpretation of the laboratory results as they relate to the patient's condition. The interpretation of laboratory results is a part of the care rendered when the physician provides and bills for a physician service such as a visit or a surgery.

(ii) Since the professional component of an anatomical procedure is a physician service, only eligible providers of physician services and independent laboratories billing on behalf of their physicians (e.g., physician-owners, staff physicians, or physicians under contract with the laboratory) may bill for the professional component of an anatomical pathology procedure.

(iii) For reimbursement of the professional component (only), the provider must bill the service using a professional claim format in accordance with rules 5101:3-1-19.1 and 5101:3-1-19.2 of the Administrative Code using the code for the anatomical pathology procedure modified by the modifier 26(e.g., 8830026).

(iv) The following anatomical pathology services are exclusively physician professional services and must always be billed using a professional claim format in accordance with rules 5101:3-1-19.1 and 5101:3-1-19.2 of the Administrative Code claim as the professional component using the 26 modifier:

(a) Clinical pathology consultations;

(b) Physician interpretation of a bloodsmear;

(c) Physician interpretation of a bone marrow smear;

(d) Blood bank physician services;

(e) Consultative services on referred materials and/or slides.

(h) Technical component

(i) The hospital must bill for the technical component of all anatomical pathology procedures performed on a hospital inpatient, a hospital outpatient, or a patient of the hospital emergency room.

(ii) For services rendered on or after July 1, 2003, the department will no longer recognize the modifier ZP. Providers performing only the technical component must bill the appropriate code modified by the modifier TC (e.g., 88300TC).

(iii) For services rendered prior to July 1, 2003, when an eligible provider of laboratory services performs only the technical component of an anatomical procedure, the provider may bill for the technical component by billing the appropriate code unmodified.

(F) Specimen collection.

(1) Reimbursement for drawing and collecting certain specimens is allowable up to a the maximum which is specified in rule 5101:3-1-60 of the Administrative Code. This fee includes the collection, handling and shipping of specimens. The collection fee may be paid only to the provider who extracted the specimen from the patient. Only one collection fee is allowed for each patient encounter per body site regardless of the number of samples drawn. When a series of specimens is required to complete a single test(e.g., glucose tolerance test), the series will be treated as a single encounter.

(2) Payment for the specimen collection is independent of the payment for the laboratory procedure. The provider who performed the specimen collection is entitled to payment regardless of where the laboratory procedure was performed.

(3) Specimen collection is covered as a laboratory service only in the following circumstances:

(a) Drawing a blood sample by venipuncture;

(b) Collecting a urine sample by catheterization; or

(c) Drawing a blood sample by capillary puncture when the specimen collected is used for the same diagnostic tests as would a specimen drawn by venipuncture but the later is not feasible because of medical complications.

(4) Specimen collection is not covered in the following circumstances:

(a) Collecting a routine urine sample;

(b) Collecting a routine culture sample;

(c) Collecting a blood sample by capillary puncture when the procedure is a part of the test procedure (e.g., bleeding time); or

(d) Collecting a pap smear or other tissue sample (except when there is a separate code available for the tissue excision).

(5) When the service is provided in a long-term care facility or a private home, specimen collection is covered as long as:

(a) The provider personally draws the specimen and is not an employee of the long-term care facility; and

(b) The patient is either homebound or confined to the long-term care facility;

(6) The following procedure codes are recognized for specimen collection:

36415 Collection of venous blood by venipuncture.

36416 Collection of capillary blood specimen (e.g., finger, heel, ear stick)

36591 Collection of blood specimen from a completely implantable venous access device

36592 Collection of blood specimen using established central or peripheral catheter, venous, not otherwise specified

P9612 Catheterization for collection of specimen, single patient all places of service.

P9615 Catheterization for collection of specimen(s) (multiple patients).

(7) The department will not reimburse providers for travel expenses associated with the collection of specimens.

(G) Clinical pathology consultative services.

(1) A physician, usually a pathologist or hematologist, may be reimbursed for clinical pathology consultations by billing the codes for clinical pathology consultations.

(2) Clinical pathology consultative services must:

(a) Be requested by the patient's attending physician;

(b) Relate to one of the clinical laboratory tests listed in appendix A of this rule or to a test result that lies outside clinically significant normal or expected range in view of the patient's condition;

(c) Result in a written narrative report prepared by the consulting physician included in patient's medical record; and

(d) Require medical interpretive judgment by the consulting physician.

(3) For reimbursement, the codes must be modified by a 26 (e.g., 8050026) and the claims must be submitted to the department with the attending physician's provider number in the referring physician space on the invoice. When the attending physician's provider number is not available, 9111115 must appear in the referring physician space on the invoice and the physician's name and address must appear in the remarks space on the invoice. In addition, the following documentation must be maintained in the patient's medical records and the records of the laboratory (if the laboratory is separate from the physician's office):

(a) A copy of the attending physician's request for a consultation;

(b) The test results including the identification of any test results that were outside the clinically significant normal or expected range in view of the condition of the patient; and

(c) A copy of the written narrative report prepared by the consulting physician.

(4) The department may recoup payments for a pathology consultation when neither the patient's medical records nor the laboratory records document that the conditions specified in paragraph (G)(3) of this rule have been met.

(H) Evocative/suppression testing.

(1) Codes 80400 to 80440 are for the laboratory component of the test (the actual measurement of the chemical constituents) and are reimbursable only to the laboratory that actually performed the laboratory analysis.

(2) A provider of physician services may be reimbursed for professional services associated with evocative/suppression testing which include the supervision and monitoring of the patient during testing, the physician's intermittent or continual attendance during the administration of the evocative/suppression drug or agent and the physician's interpretation of the test results as they relate to the patient's condition. Evaluation and management codes may be billed for the same date of services if the physician provided separate and identifiable evaluation and management services to the patient.

(3) Reimbursement is available to a provider of physician services for evocative/suppression testing agents administered in a non-hospital setting by billing the appropriate injection codes in accordance with rule 5101:3-4-13 of the Administrative Code. The injection codes include the provision of the drug/chemical agent and the administration of the drug/agent when the drug/agent is administered intradermally, subcutaneously, intramuscularly, intraarterially, or intravenously (via injection, push IV, or an IV infusion of short duration).

(4) When the administration of the evocative/suppression agent in a non-hospital setting requires prolonged intravenous infusions the provider may also receive reimbursement for prolonged infusion services by billing codes 90780 and 90781 in addition to the codes for the drug/agent. Reimbursement for these codes include the additional supplies used in the prolonged administration of the drug agent.

(I) Billing the laboratory procedure codes.

(1) The provider must assign the most appropriate code for each laboratory procedure performed. Some procedures are listed by the name of the substance (analyte) being measured; some are listed by methodology (e.g., RIA, EIA, TLC, Culture, etc.); some are listed by both the name and methodology; and some are differentiated by the specimen type (e.g., urine, blood, etc.).

(2) The provider must bill the code that describes the procedure in the most detail. Codes using the term "not elsewhere specified" in the definition for the procedure may only be used when the laboratory is performing a quantitative test for a specific analyte for which there is no specific code.

(3) Many laboratory procedures, especially procedures for drug level testing, have synonyms. Therefore, the name the laboratory uses for a test may not be the same name used in the. When a synonym for a laboratory procedure exists, the provider must bill using the synonymous code.

(4) If a suitable procedure is not available for the substance (analyte) or method, the provider must bill the miscellaneous or unlisted laboratory procedure code listed under the laboratory specialty for the procedure. These codes must be billed "by report."

(a) When billing the unlisted laboratory procedure codes, the name of the substance being measured, the specimen type, and the methodology must be written in the remarks column of the claim form.

(b) Claims omitting this information or billing the unlisted codes when a code is available may be denied by the department.

(J) Reimbursement for neonatal diagnostic screening kits.

(1) A "neonatal diagnostic screen kit" is a laboratory kit used for screening neonates for phenylketonuria, homocystinuria, galactomsemia, hypothyroidism, or other genetic endocrine or metabolic disorders.

(2) Reimbursement for neonatal diagnostic screening kits which are purchased from the Ohio department of health state laboratory is allowable to the physician, hospital, or clinic if one of the following circumstances applies:

(a) The screen was performed for the first time because the infant was not born in a hospital and was never admitted to the hospital; or

(b) The screen was repeated because the infant was released from the hospital prior to reaching forty eight hours of age; or

(c) The screen was repeated because the original screen of the infant showed an abnormal result and the infant is no longer an inpatient of the hospital.

(3) The department will recognize code S3620 for the reimbursement of the neonatal diagnostic screen kit.

(K) Non-covered laboratory services.

(1) The following laboratory services are non-covered under medicaid:

(a) Laboratory services exceeding the coverage and limitations set forth in Chapter 5101:3-11 of the Administrative Code;

(b) Routine laboratory and screening procedures;

(c) Laboratory services performed in conjunction with non-covered physician services as defined in rule 5101:3-4-28 of the Administrative Code;

(d) Laboratory services performed for forensic reasons;

(e) Paternity testing; and

(f) Laboratory procedures performed in conjunction with an autopsy.

(2) The recipient's liability for non-covered laboratory services is detailed in rule 5101:3-1-13.1 of the Administrative Code. In addition, the recipient may not be billed for any laboratory procedures performed by a laboratory that is not certified to perform the procedure under CLIA.

APPENDIX

Laboratory Services

CODE DEFINITION

83020 Hemogolbin electrophorisis

83912 Nucleic acid probe, with electrophoresis, exam and report

84165 Protein, total serum; electrophorectic fractionization and quantitation

84166 Protein electrophoretic fraction quart

84181 Western blot

84182 Western blot, immunologic probe

85390 Fibrinolysin; screening

85396 Fibrinolysin; screening

85576 Platelet aggregation (In Vitro), any agent

86255 Fluorescent antibody; screen

86256 Fluorescent antibody; titer

86320 Immunoelectrophoresis; each specimen

86325 Immunoelectrophoresis; other fluids with concentration, each specimen

86327 Immunoelectrophoresis, crossed (2-D)

86334 Immunofixation electrophoresis

86335 Immunofix electrophresis fluid w/concern

87164 Darkfield examination, any source; includes specimen collection

87207 Smear; primary source, with interpretation; special stain for inclusion bodies or intracellular parasites

89060 Crystal ID by light microscopy w/wo polar lens; any fluid not urine

88245 Chromosome analysis

88248 Chromosome analysis

88261 Chromosome analysis

88262 Chromosome analysis

88263 Chromosome analysis

88267 Chromosome analysis

88269 Chromosome analysis

88280 Chromosome analysis

88283 Chromosome analysis

88285 Chromosome analysis

88289 Chromosome analysis

88299 Chromosome analysis

Effective: 03/30/2008
R.C. 119.032 review dates: 04/01/2009
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 04/07/1977, 09/19/1977, 12/21/1977, 12/30/1977, 06/03/1983, 10/01/1983 (Emer), 12/29/1983, 10/01/1984 (Emer), 12/30/1984, 01/01/1986, 50/09/1986, 06/01/1986, 06/16/1988, 01/13/1989 (Emer), 04/13/1989, 09/01/1989, 02/17/1991, 04/01/1992 (Emer), 07/01/1992, 09/02/1992 (Emer), 04/30/1993 (Emer), 07/01/1993, 12/30/1993 (Emer), 03/31/1994, 12/29/1995 (Emer), 03/21/1996, 12/31/1997 (Emer), 03/19/1998, 12/31/1998 (Emer), 03/31/1999, 08/01/2001, 02/01/2003, 04/01/2004, 12/30/2005 (Emer), 03/27/2006, 12/31/2007 (Emer)

5160-11-04 Laboratory: exceptions for FQHCs, RHCs, OHFs, and hospital outpatients.

(A) Definitions.

For the purpose of this rule:

(1) "Facility" means any federally qualified health center (FQHC), rural health center (RHC), or outpatient health facility (OHF) that has signed an Ohio medicaid "provider agreement."

(2) A facility shall be considered "related to" another facility if one facility owns the other facility or the two facilities are owned by the same (separate) entity.

(3) A "hospital provider" is a hospital eligible for participation in the medicaid program in accordance with rule 5101:3-2-01 of the administrative code.

(4) "Clinical Laboratory Improvement Amendment" (CLIA) sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens.

(B) FQHCs, RHCs, OHFs or the combination of any of the three may bill for laboratory procedures they do not actually perform if:

(1) The procedures were referred to and performed by a facility that is related to the referring FQHC, RHC, or OHF.

(2) The (reference) facility that actually performed the procedures is certified to perform the service under the clinical laboratory improvement amendments (CLIA).

(3) The referring facility discloses, in writing to the department, the following information:

(a) The name, address, and CLIA number of the reference facility;

(b) Information on the ownership of and/or relationship between the referring facility and the reference facility; and

(c) A list of the laboratory procedures referred to the reference facility.

(4) The referring facility must notify the department in writing of any changes made to the disclosure information specified in paragraph (B)(3) of this rule.

(5) The department will exclude from the cost reports any costs allocated for laboratory procedures performed by facilities or laboratories that are not certified to perform the procedures under CLIA.

(C) For hospital outpatients, hospital providers may bill for clinical laboratory procedures they do not actually perform, when the procedures are referred to and performed by a laboratory that is certified to perform the service under the CLIA.

(a) When clinical laboratory services for hospital outpatients are performed by a reference laboratory, the referring hospital provider must have a written arrangement with the reference laboratory that specifies which provider will bill the department for the laboratory services. If the hospital provider bills for a clinical laboratory service performed by a reference laboratory, the reference laboratory must not bill either medicaid or the beneficiary for its service. If the reference laboratory bills for the clinical laboratory service, the referring hospital must not bill either medicaid or the beneficiary for the service.

(b) In the event that the department issues payment to both the referring hospital and the reference laboratory for the same clinical laboratory service, the department will make the assumption that the payment issued to the reference laboratory is subject to recovery.

Effective: 05/25/2006
R.C. 119.032 review dates: 03/09/2006 and 05/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02
Prior Effective Dates: 2/7/91, 9/2/92 (Emer), 12/1/92, 12/31/98 (Emer), 3/31/99

5160-11-05 Laboratory specimens sent to the Ohio department of health (ODH) state laboratories.

(A) Providers may not bill the department for procedures performed by the Ohio department of health (ODH) state laboratory.

(B) All Ohio medicaid providers who wish to utilize the ODH state laboratory for laboratory tests performed for medicaid consumers must:

(1) Complete the top portion of the CMS 1500 claim form (rev. September 2003), for each consumer (i.e., consumers information only).

(2) Include the CMS 1500 claim form along with all other attachments required by ODH in the package with the specimen and submit to ODH.

(3) Not attach the prepaid stamp that ODH normally requires before the test is performed.

(C) The ODH state laboratory will complete the CMS 1500 claim form and submit the claim for payment.

Effective: 05/25/2006
R.C. 119.032 review dates: 03/09/2006 and 05/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02
Prior Effective Dates: 2/17/91, 8/1/2001

5160-11-06 Portable x-ray suppliers: covered services and limitations.

(A) Portable x-ray services are limited to the following radiology services:

(1) Skeletal films involving the extremities, pelvis, vertebral column, and skull;

(2) Chest films that do not involve the use of contrast media;

(3) Abdominal films that do not involve the use of contrast media.-and;

(4) Diagnostic mammograms if the provider meets the requirements in 21 C.F.R. (April 1, 2005) part 900 subpart B.

(B) Procedures and examinations that are not covered when provided by a portable x-ray provider include:

(1) Procedures involving fluoroscopy;

(2) Procedures involving the use of contrast media;

(3) Procedures requiring the administration of a substance to the patient or the injection of a substance into the patient and/or special manipulation of the patient;

(4) Procedures that require special medical skill or knowledge possessed by a doctor of medicine or doctor of osteopathy, or that require that medical judgment be exercised;

(5) Procedures requiring special technical competency and/or special equipment or materials;

(6) Routine screening procedures; and

(7) Procedures that are not of a diagnostic nature.

(C) Reimbursement is available for the transportation of portable x-ray equipment to a patient's home, or to a long-term care facility (LTCF). In a LTCF, only one such charge per visit, to the supplier is allowed, regardless of the number of patients seen.

(D) For a portable x-ray service to be covered under medicaid:

(1) The service must be medically necessary as defined under rule 5101:3-1-01 of the Administrative Code; and

(2) The service must be requested by a physician in writing.

(a) The service may be performed on the verbal request of a physician but the laboratory must obtain a written order dated and signed by the physician before the services may be billed to the department.

(b) The physician's order must specify the reason the x-ray is medically necessary and must specify the x-ray procedure(s) to be performed, including the number of radiographs to be obtained and the views needed.

(c) The service must be performed under the general supervision of a physician.

(E) The portable x-ray supplier must keep the following records for each patient for a period of at least six years:

(1) The date of the x-ray examination;

(2) A copy of the written, signed and dated order by the patient's physician;

(3) The name of the operator(s) of the portable x-ray equipment; and

(4) The name of the physician who performed the professional interpretation of the procedure and the date the radiograph was sent to the physician.

(F) Billing for portable x-ray supplier services.

(1) Portable x-ray suppliers may bill for the total procedure of a covered x-ray service if the supplier provided both the technical and the professional components of the procedure.

(a) For the supplier to be eligible for reimbursement of the total procedure, the professional component must be provided by a qualified physician who either owns, is employed by or is under contract with the portable x-ray supplier.

(b) To bill for the total procedure of a covered portable x-ray service, the provider must bill the CPT code, in accordance with division-level 5101:3 of the Administrative Code, for the procedure without a modifier.

(2) Portable x-ray suppliers may only bill for the technical component when the supplier performed the technical services and a physician not associated with the supplier by ownership, employment, or contract provided the professional services (e.g., the patient's treating physician interpreted the x-ray procedure).

To bill for the technical component, the provider must bill the CPT code for the procedure followed by the modifier TC (e.g., 71010TC).

(3) A portable x-ray supplier may not bill separately for the professional component.

Effective: 05/25/2006
R.C. 119.032 review dates: 03/09/2006 and 05/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02
Prior Effective Dates: 4/7/77, 9/19/77, 12/21/77, 12/30/77, 10/1/84 (Emer), 12/30/84, 6/1/86, 2/17/91, 8/1/01

5160-11-07 Independent diagnostic testing facility: coverage and limitations.

(A) For independent diagnostic testing facility services to be covered:

(1) The service must be medically necessary as defined in rule 5101:3-1-01 of the Administrative Code; and

(2) The service must be requested in writing by a the treating physician or non-physician practitioner in accordance with state law.

(a) The service may be performed upon the verbal order of a the treating physician but the independent diagnostic testing facility must obtain an order that is written, dated, and signed by the treating physician before the service is billed to the department.

(b) The treating physician's order must specify the procedures to be performed and the reason for the service.

(c) A copy of the written, dated, and signed treating physician's order must be kept on file for six years.

(d) The independent diagnostic testing facility may not add any procedures based on internal protocols without a written order by the treating physician.

(B) An independent diagnostic test facility may not perform or bill for CLIA tests. An entity that owns both an independent diagnostic testing facility and an independent laboratory should enroll and bill separately to Ohio medicaid.

(C) Services are reimbursable directly to a independent diagnostic testing facility only if the services were rendered to a nonhospital patient and the independent diagnostic testing facility provided all services (professional and technical) associated with the total procedure as the procedure is defined in the CPT with the following exceptions:

(1) When separate CPT codes itemize a service by its professional and technical components, the independent diagnostic testing facility may bill and be reimbursed for the components of the procedure it actually performed.

(2) When the service provided is an echocardiography or a radiology procedure, the independent diagnostic testing facility may provide, bill and be reimbursed for either the total procedure or for the technical component of the procedure.

(a) To bill for the technical component of an echocardiography or a radiology procedure, the independent diagnostic testing facility must bill the CPT code followed by the modifier TC (e.g., 93307TC).

(b) To bill for the total procedure, the independent diagnostic testing facility must bill the CPT code without a modifier.

(D) When an independent diagnostic testing facility provides services for a hospital inpatient, a hospital outpatient, or a hospital emergency room patient, the hospital must bill and be reimbursed for the technical services associated with the procedure and the physician who provided the professional services associated with the procedure must bill for the professional component. The independent diagnostic testing must make separate arrangements to receive payment from the hospital for the services rendered to a hospital patient.

Effective: 05/25/2006
R.C. 119.032 review dates: 03/09/2006 and 05/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02
Prior Effective Dates: 2/17/91, 8/1/01

5160-11-08 Reimbursement for laboratory, portable x-ray supplier, and independent diagnostic testing facilities.

(A) Payment for services is the provider's billed charges or the medicaid maximum payment schedule (sometimes referred to as the medicaid maximum or the fee schedule) as specified in this rule, whichever is lower.

(B) Medicaid maximum for laboratory services.

(1) For a laboratory service that is payable under the medicare laboratory fee schedule, the medicaid payment for the service shall not exceed the medicare carrier's laboratory fee schedule for that service.

(2) The maximum amount payable for clinical laboratory procedures is specified in appendix DD of rule 5101:3-1-60 of the Administrative Code.

(3) The maximum amount payable for the total procedure of an anatomical pathology procedure is specified in rule 5101:3-1-60 of the Administrative Code.

(4) The maximum amount payable for the professional component of anatomical pathology procedures is specified by the corresponding professional/technical indicator in appendix DD of rule 5101:3-1-60 of the Administrative Code.

(5) The maximum amount payable for the technical component of anatomical pathology procedures is specified by the corresponding professional/technical indicator in appendix DD of rule 5101:3-1-60 of the Administrative Code.

(C) Medicaid maximum for radiology services.

(1) The maximum amount payable for the total procedure for a radiology service is specified in rule 5101:3-4-25 of the Administrative Code.

(2) The maximum amount payable for the professional component of a radiology service is specified of rule 5101:3-4-25 of the Administrative Code.

(3) The maximum amount payable for the technical component of a radiology service is specified in rule 5101:3-4-25 of the Administrative Code.

(D) Medicaid maximum for other independent diagnostic testing facilities.

For independent diagnostic testing facilities services not included in those services referred to in paragraph (C) of this rule:

(1) The maximum amount payable for those procedures for which the department recognizes professional and technical components is specified in rule 5101:3-4-11 of the Administrative Code.

(2) The maximum amount payable for all other procedures is specified in appendix DD of rule 5101:3-1-60 of the Administrative Code.

(E) Laboratory, radiology, and diagnostic and therapeutic services provided to hospital inpatients.

(1) The following services furnished to hospital inpatients are covered under the medicaid program as inpatient hospital services and are reimbursed in accordance with provisions governing payment for inpatient services as set forth in Chapter 5101:3-2 of the Administrative Code:

(a) Clinical laboratory services;

(b) The technical component of anatomical pathology procedures; and

(c) The technical component of radiology, and diagnostic and therapeutic services.

(2) The department will deny separate charges made by providers, or will recoup separate payments made to providers, for services specified in paragraph (E) of this rule which were rendered for hospital inpatients.

Eff 10-1-84; 10-1-84 (Emer.); 12-30-84; 5-9-86; 2-17-91; 2-1-96 (Emer.); 4-4-96; 8-1-01; 4-1-04
Rule promulgated under: RC 119.03
Rule authorized by: RC 5111.02
Rule amplifies: RC 5111.01 , 5111.02
RC 119.032 review dates: 4/6/01, 4/6/06, 1/16/04, 4/1/09

5160-11-10 Radiology procedures that are subject to the clinical laboratory improvement amendments (CLIA) requirements.

(A) Any providers submitting claims for the radiology procedures listed in this rule citing either the technical component only or the technical and professional component combined must be certified under CLIA.

(B) Any providers submitting claims citing only the performance of the professional component of the radiology procedures listed in this rule are not subject to the requirements under CLIA.

78110 Plasma volume, radionuclide volume-dilution technique; single sampling.

78111 Plasma volume, radionuclide volume-dilution technique; multiple sampling.

78120 Red cell volume determination; single sampling.

78121 Red cell volume determination; multiple sampling.

78122 Red cell volume determination; multiple sampling.

78130 Red cell survival study.

78191 Platelet survival study.

78270 Vitamin B-12 absorption studies combined, with and without intrinsic factor.

78271 Vitamin B-12 absorption studies combined, with and with intrinsic factor.

78272 Vitamin B-12 absorption studies combined, with and without intrinsic factor.

Effective: 03/27/2006
R.C. 119.032 review dates: 01/10/2006 and 03/01/2011
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02
Prior Effective Dates: 7/1/93, 12/31/98 (Emer), 3/31/99, 12/30/05 (Emer)