Cal. Code Regs. tit. 22 § 51529

Current through Register 2024 Notice Reg. No. 19, May 10, 2024

Section 51529 - Pathology Services

(a) This section applies to all laboratory services excluding those performed for hospital inpatients and billed as part of the hospital cost reimbursement billing, and excluding those tests with rates incorporated in section 51503(b).

(1) Payment shall be made only for tests performed by standard procedures and techniques commonly employed by clinical laboratories. No payment shall be made to any provider for a laboratory test performed by a laboratory that is not qualified for reimbursement under the Medicare program (Title XVIII) for that test.

(2) Reimbursement for laboratory tests shall be the least of the following:

(A) The amount billed.

(B) The charge to the general public.

(C) 80 percent of the lowest maximum allowance established by the federal Medicare program for the same or similar services.

(3) Reimbursements pursuant to this section shall be made only to a provider who actually performed the pathology services. No provider shall bill the Medi-Cal program for pathology services, including collection and handling services, the provider did not actually perform. For purposes of this section, services shall be deemed to have been performed by the provider if the services are performed by the provider personally, or by an employee of the provider.

(4) Reimbursement for collection and handling of specimens is payable only in accordance with the following:

(A) The specimen is a blood sample.

(B) The specimen is forwarded to an outside laboratory.

(C) The following code is billed:

Code 99000: Handling and/or conveyance of specimen for transfer from the physician's office to a laboratory.

Code 99000 includes any or all of the following: Single or multiple venipuncture, capillary puncture or arterial puncture with one or more tubes, centrifugation and serum separation, freezing, refrigeration, preparation for air transportation or other special handling procedures, supplies, registration of patient or specimen, and third party billing.

(D) Reimbursement shall be made for only one collection and handling procedure per day per provider for each beneficiary.

(E) Reimbursement shall be the least of the following:

1. The amount billed

2. The charge to the general public

3. Medicare's maximum allowance.

(5) Laboratory services necessary for chronic outpatient hemodialysis in renal dialysis centers and community hemodialysis units are payable only when billed by the renal dialysis center or community hemodialysis units.

(b) Newborn screening for heritable disorders mandated by law and prenatal screening for birth defects shall be reimbursed at the rate as established by the Department of Health Care Services pursuant to regulations as provided in sections 6508 and 6529, Title 17, California Code of Regulations.

(c) Any combination of two or more tests which are performed together on automated laboratory equipment shall be billed and reimbursed as an automated test.

(d) No reimbursement shall be made by the Medi-Cal program for any service which comes within the definition of laboratory services or clinical laboratory services unless the provider of service and all other persons or entities performing, supervising, consulting on, or directing the laboratory or clinical laboratory services for which reimbursement is sought from the Medi-Cal program are in compliance with the requirements of section 51211.2.

(e) If the Department determines that a provider of service no longer substantially meets the requirements for participation because one or more condition level deficiencies, as defined in 17 CCR 1029.55, exist; or immediate jeopardy, as defined in 17 CCR 1029.95, exists; or the license, registration or approval has been temporarily suspended, as defined in 17 CCR 1029.173, the Department may in lieu of, or in addition to, any other available sanction, and prior to hearing, temporarily suspend a provider of service from the Medi-Cal program and not pay all or part of the Medi-Cal and Medicaid reimbursements to which the provider would otherwise be entitled, provided that in the opinion of the Director such action is necessary to protect the public welfare or the interests of the Medi-Cal program. The Department shall follow the procedures identified in 17 CCR 1067.15 in taking such action. If it is determined upon judicial review that immediate jeopardy did not exist or if an adjudicatory hearing results in a final decision that condition level deficiencies did not exist, the provider of service may submit claims for the period of time for which the provider of service was temporarily suspended. Reimbursement of such claims shall be made to the same extent it would have been made if the provider of service had not been temporarily suspended and the claim had been submitted timely.

Cal. Code Regs. Tit. 22, § 51529

1. Certificate of Compliance as to 12-21-82 order transmitted to OAL 4-19-83 and filed 5-24-83 (Register 83, No. 22). For prior history, see Register 82, No. 52.
2. Amendment of subsections (a)(4)(E), (b), and (c) filed 8-1-84 as an emergency; effective upon filing (Register 84, No. 31). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 11-29-84.
3. Certificate of Compliance including amendment of subsections (a)(2) and (a)(4) transmitted to OAL 11-27-84 and filed 12-27-84 (Register 84, No. 52).
4. Amendment of subsections (a)(4)(E), (b) and (c) filed 8-1-85 as an emergency; effective upon filing (Register 85, No. 32). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 11-29-85.
5. Certificate of Compliance transmitted to OAL 11-20-85 and filed 12-27-85 (Register 85, No. 52).
6. Change without regulatory effect of subsection (d) (Register 87, No. 25).
7. Amendment of subsections (b)-(d) filed 10-1-87; operative 10-31-87 (Register 87, No. 41).
8. Amendment of subsection (d) filed 12-6-90 as an emergency by the Department of Health Services with the Secretary of State; operative 12-6-90. Submitted to OAL for printing only pursuant to Health and Safety Code 309(g) (Register 91, No. 14).
9. Certificate of Compliance as to 12-6-90 order transmitted to OAL 3-19-91; exempted from OAL review pursuant to Health and Safety Code section 309(h); filed with the Secretary of State 4-18-91 (Register 91, No. 20).
10. Editorial correction of printing error in subsection (d) (Register 91, No. 32).
11. New subsection (f) and amendment of NOTE filed 1-20-94 as an emergency; operative 1-20-94 (Register 94, No. 3). A Certificate of Compliance must be transmitted to OAL by 5-20-94 or emergency language will be repealed by operation of law on the following day.
12. Certificate of Compliance as to 1-20-94 order transmitted to OAL 5-19-94 and filed 7-1-94 (Register 94, No. 26).
13. Amendment of subsections (a)(4)(C), (b) and (e) filed 7-28-97 as an emergency; operative 7-28-97 (Register 97, No. 31). A Certificate of Compliance must be transmitted to OAL by 11-25-97 or emergency language will be repealed by operation of law on the following day.
14. Amendment of subsection (f), new subsection (g) and amendment of NOTE filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.
15. Certificate of Compliance as to 7-28-97 order transmitted to OAL 11-19-97 and filed 1-6-98 (Register 98, No. 2).
16. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).
17. Change without regulatory effect amending subsection (g) filed 5-14-2001 pursuant to section 100, title 1, California Code of Regulations (Register 2001, No. 20).
18. Amendment of subsection (a), new subsection (h) and amendment of NOTE filed 7-16-2002; operative rates for services provided on or after 8-1-2000 pursuant to Stats. 2000, c. 52, Items 4260-101-0001 and 0890 (Register 2002, No. 29).
19. Certificate of Compliance as to 7-16-2002 order, including repealer of subsection (h), transmitted to OAL 11-12-2002 and filed 12-24-2002 (Register 2002, No. 52).
20. Change without regulatory effect amending section and NOTE filed 7-22-2009 pursuant to section 100, title 1, California Code of Regulations (Register 2009, No. 30).

Note: Authority cited: Sections 20 and 309(b), Health and Safety Code; Sections 10725, 14105 and 14124.5, Welfare and Institutions Code. Reference: Sections 101150- 101165, 124980, 124985, 124990 and 124995, Health and Safety Code; Sections 14105, 14105.05, 14105.22, 14115.4, 14123 and 14134.2, Welfare and Institutions Code; Sections 1206, 1220, 1272 and 1272.6, Business and Professions Code; Statutes of 1982, Chapter 1594, Sections 77 and 79; Statutes of 1983, Chapter 323, Section 149; Statutes of 1984, Chapter 258, Items 4260-106-001 and 890; Statutes of 1984, Chapter 268, Section 66; Statutes of 1985, Chapter 111, Items 4260-106-001 and 890; Section 433.123, Title 42, Code of Federal Regulations; Title 42 United States Code, Section 263a; 42 USC, Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Sections 1001.201 through 1001.1701 and 1002.2; and Statutes of 2000, Chapter 52, Items 4260-101-0001 and 0890.

1. Certificate of Compliance as to 12-21-82 order transmitted to OAL 4-19-83 and filed 5-24-83 (Register 83, No. 22). For prior history, see Register 82, No. 52.
2. Amendment of subsections (a)(4)(E), (b), and (c) filed 8-1-84 as an emergency; effective upon filing (Register 84, No. 31). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 11-29-84.
3. Certificate of Compliance including amendment of subsections (a)(2) and (a)(4) transmitted to OAL 11-27-84 and filed 12-27-84 (Register 84, No. 52).
4. Amendment of subsections (a)(4)(E), (b) and (c) filed 8-1-85 as an emergency; effective upon filing (Register 85, No. 32). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 11-29-85.
5. Certificate of Compliance transmitted to OAL 11-20-85 and filed 12-27-85 (Register 85, No. 52).
6. Change without regulatory effect of subsection (d) (Register 87, No. 25).
7. Amendment of subsections (b)-(d) filed 10-1-87; operative 10-31-87 (Register 87, No. 41).
8. Amendment of subsection (d) filed 12-6-90 as an emergency by the Department of Health Services with the Secretary of State; operative 12-6-90. Submitted to OAL for printing only pursuant to Health and Safety Code 309(g) (Register 91, No. 14).
9. Certificate of Compliance as to 12-6-90 order transmitted to OAL 3-19-91; exempted from OAL review pursuant to Health and Safety Code section 309(h); filed with the Secretary of State 4-18-91 (Register 91, No. 20).
10. Editorial correction of printing error in subsection (d) (Register 91, No. 32).
11. New subsection (f) and amendment of Note filed 1-20-94 as an emergency; operative 1-20-94 (Register 94, No. 3). A Certificate of Compliance must be transmitted to OAL by 5-20-94 or emergency language will be repealed by operation of law on the following day.
12. Certificate of Compliance as to 1-20-94 order transmitted to OAL 5-19-94 and filed 7-1-94 (Register 94, No. 26).
13. Amendment of subsections (a)(4)(C), (b) and (e) filed 7-28-97 as an emergency; operative 7-28-97 (Register 97, No. 31). A Certificate of Compliance must be transmitted to OAL by 11-25-97 or emergency language will be repealed by operation of law on the following day.
14. Amendment of subsection (f), new subsection (g) and amendment of Note filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.
15. Certificate of Compliance as to 7-28-97 order transmitted to OAL 11-19-97 and filed 1-6-98 (Register 98, No. 2).
16. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).
17. Change without regulatory effect amending subsection (g) filed 5-14-2001 pursuant to section 100, title 1, California Code of Regulations (Register 2001, No. 20).
18. Amendment of subsection (a), new subsection (h) and amendment of Note filed 7-16-2002; operative rates for services provided on or after 8-1-2000 pursuant to Stats. 2000, c. 52 Items 4260-101-0001 and 0890 (Register 2002, No. 29).
19. Certificate of Compliance as to 7-16-2002 order, including repealer of subsection (h), transmitted to OAL 11-12-2002 and filed 12-24-2002 (Register 2002, No. 52).
20. Change without regulatory effect amending section and Note filed 7-22-2009 pursuant to section 100, title 1, California Code of Regulations (Register 2009, No. 30).