5101:3-11-03 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)