Cal. Code Regs. tit. 22 § 51513

Current through Register 2024 Notice Reg. No. 18, May 3, 2024

Section 51513 - Pharmaceutical Services and Prescribed Drugs

(a) Definitions. The following definitions and definitions pursuant to Welfare and Institutions Code, Section 14105.45 shall be applicable to this section.

(1) Average Wholesale Price (AWP) means the price for a drug product listed for a standard package in the Department's primary price reference source. The selection of the primary price reference source shall be based upon an evaluation of the various price reference sources available in relation to the following criteria:

(A) Accuracy and currentness of prices.

(B) Comprehensiveness of data base.

(C) Capability to meet the needs of the Department's fiscal intermediary.

The primary price reference source will be the price reference source that, in the judgment of the Director, best meets the criteria specified above.

(2) A Standard Package means 100s, pints or pounds, if commercially available; or the commercially available size that is next above 100s, pints or pounds; or, in the case of larger quantities, that size which is closest to the quantity dispensed; or, in the case of conventional dispensing units, the unit dispensed; or, in those cases in which the only commercially available sizes are less than 100s, pints or pounds, the package closest to the amount dispensed. Where the most frequently purchased size differs from the above limits, a standard package shall mean that package size determined by the Director to be the size most frequently purchased by providers, and designated with a "++" on the Medi-Cal List of Contract Drugs. The National Drug Code (NDC) of the Package from which the drug is dispensed shall be used when billing Medi-Cal. Payment for the drug dispensed is based on a standard package as defined in this subsection.

(b) Payment for Legend and Nonlegend Drugs.

(1) Payment for legend and nonlegend drugs dispensed by licensed pharmacists in compliance with Section 51313 shall be in accordance with Welfare and Institutions Code, Section 14105.45. Payments for legend and nonlegend drugs dispensed by a clinic with a special permit pursuant to Business and Professions Code, Section 4063, and provided in compliance with Section 51313 shall consist of the cost of the legend or nonlegend drugs.

(A) The price charged to the program shall not exceed that charged to the general public.

(B) The pharmacist or the clinic with a special permit, to the extent permitted by law, shall dispense the lowest cost drug product within the generically equivalent drugs that the pharmacy or clinic with a special permit has in stock which meets the medical needs of the beneficiary.

(2) Payment to a pharmacy for both the professional fee component and the ingredient cost component for legend and nonlegend drugs listed in the Medi-Cal List of Contract Drugs and preceded by "#" shall be limited to drugs dispensed in minimum quantities of 100 dosage units. Payment to a pharmacy for less than 100 dosage units for legend and nonlegend drugs listed in the Medi-Cal List of Contract Drugs and preceded by "#" shall be for the ingredient cost only. One hundred dosage units means 100 tablets or capsules. Exceptions to this requirement shall be:

(A) The initial prescription for the generically equivalent drugs for the beneficiary.

(B) Those prescriptions for which prior authorization is obtained from a Medi-Cal consultant.

(C) Those prescriptions for skilled nursing facility or intermediate care facility inpatients; however, such prescriptions shall be subject to the requirements of subsection (b)(3).

(3) Payment to a pharmacy for both the professional fee component and the ingredient cost component of claims for dispensing legend and nonlegend drugs listed in the Medi-Cal List of Contract Drugs and preceded by "+" shall be limited to a maximum of three such payments in any 75-day period when the same generically equivalent drugs is provided to the same beneficiary. Payment to a pharmacy for more than three such claims in any 75-day period shall be limited to the ingredient cost only. Exceptions to this requirement shall be:

(A) The initial prescription for the generically equivalent drug for the beneficiary.

(B) Those prescriptions for which prior authorization is obtained from a Medi-Cal consultant.

(C) Any drug dispensed in a quantity of 180 or more tablets or capsules.

(4) Payment to a pharmacy for oral contraceptive legend drugs listed in Part 1 of the Medi-Cal List of Contract Drugs shall be limited to a minimum quantity of three cycles. Payment to a pharmacy for less than a quantity of three cycles shall be for the ingredient cost only. Exceptions to this requirement shall be:

(A) The initial prescription for the legend generically equivalent drugs for the beneficiary.

(B) Those prescriptions for which prior authorization is obtained from a Medi-Cal consultant.

(5) Payment to a pharmacy for both the professional fee component and the ingredient cost component for theophylline liquid or for liquid potassium supplement legend drugs listed in Part 1 of the Medi-Cal List of Contract Drugs shall be limited to a minimum quantity of 480 cc. Payment to a pharmacy for less than a quantity of 480 cc shall be for the ingredient cost only. Exceptions to this requirement shall be:

(A) The initial prescription for the legend generically equivalent drug for the beneficiary.

(B) Those prescriptions for which prior authorization is obtained from a Medi-Cal consultant.

(c) Fee for Service. Charges for extemporaneously compounded prescriptions shall be allowed according to the following schedule:

Capsules and Papers
6-36..........................	$1.98
37-100..........................	3.95
Ointments
up to 180 Gm..........................	1.64
180 Gm and over..........................	3.29
Suppositories
up to 24..........................	3.29
24 and over..........................	5.76
Sterile Eye Preparations
All..........................	2.04
Nose and Ear Preparations
All..........................	0.81
Emulsions
up to 240cc..........................	0.81
240cc and over..........................	1.64
Liquids other than simple pouring or reconstituting
All..........................	0.99

(d) Fee for Partial Prescription Refills. The fee for a partial prescription refilled in accordance with Business and Professions Code Section 4229.5 or Health and Safety Code Section 11201 shall be the fee amount allowed for refill of the full prescription quantity multiplied by the percent of the full prescription quantity finally refilled. The total of the fees for partial refills of such prescription shall not exceed the fee for the same prescription when refilled as a routine service. The claim for the completed service, signed by the provider, shall reflect such fee determination.

(e) Drugs Administered for Chronic Outpatient Hemodialysis. Drugs administered for chronic outpatient hemodialysis in renal dialysis centers and community hemodialysis units are payable only when included in the all inclusive rate set forth in Section 51509.2.

Cal. Code Regs. Tit. 22, § 51513

1. Amendment of subsection (d) 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. For prior history, see Registers 83, No. 34; and 82, No. 49.
2. Amendment of subsections (a), (a)(10), (a)(12) and (a)(13) filed 10-3-84; effective thirtieth day thereafter (Register 84, No. 40).
3. Certificate of Compliance as to 8-1-84 order transmitted to OAL 11-27-84 and filed 12-27-84 (Register 84, No. 52).
4. Amendment of subsection (d) filed 1-31-85 as an emergency; designated effective 2-1-85 (Register 85, No. 5). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 6-1-85.
5. Certificate of Compliance transmitted to OAL 5-23-85 and filed 6-24-85 (Register 85, No. 26).
6. Amendment of subsection (d) 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.
7. Relettering of subsections (d)-(f) to subsections (e)-(g) and new subsection (d) filed 9-16-85 as an emergency; effective upon filing (Register 85, No. 39). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 1-14-86.
8. Certificate of Compliance as to 8-1-85 order transmitted to OAL 11-20-85 and filed 12-27-85 (Register 85, No. 52).
9. Certificate of Compliance as to 9-16-85 order transmitted to OAL 1-2-86 and filed 2-3-86 (Register 86, No. 7).
10. Amendment of subsections (a)(9), (a)(13), (b)(4) and (b)(5) filed 7-28-86; designated effective 9-1-86 (Register 86, No. 31).
11. Amendment of subsection (a)(13) filed 6-10-87; operative 7-10-87 (Register 87, No. 25).
12. Amendment of subsections (a)(12)-(14) filed 10-27-87 as an emergency; operative 10-29-87 (Register 87, No. 44). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 2-26-88.
13. Certificate of Compliance transmitted to OAL 2-24-88 and filed 3-25-88 (Register 88, No. 14).
14. Amendment of subsection (a)(8) filed 9-14-89 as an emergency; operative 10-16-89 (Register 89, No. 38). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 2-13-90.
15. Amendment of subsection (a)(8) refiled 2-13-90 as an emergency; operative 2-13-90 (Register 90, No. 9). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 6-13-90.
16. Certificate of Compliance as to 2-13-90 order transmitted to OAL 6-8-90 and disapproved 7-9-90 (Register 90, No. 34).
17. Amendment of subsection (a)(8) refiled 7-12-90 as an emergency; operative 7-12-90 (Register 90, No. 34). A Certificate of Compliance must be transmitted to OAL by 11-9-90 or emergency language will be repealed by operation of law on the following day.
18. Amendment of subsection (a)(8) refiled 11-16-90 as an emergency; operative 11-16-90 (Register 90, No. 52). A Certificate of Compliance must be transmitted to OAL by 3-18-91 or emergency language will be repealed by operation of law on the following day.
19. Amendment of subsections (a) and (e), and NOTE filed 3-22-91; operative 4-21-91 (Register 91, No. 15).
20. Certificate of Compliance as to 11-16-90 order including amendment of NOTE transmitted to OAL 3-12-91 and filed 4-11-91 (Register 91, No. 17).
21. Amendment of subsections (a), (b), (c) and (d) and repealer of subsections (e) and (f) filed 5-22-91 as an emergency pursuant to Statutes of 1990, chapter 456, section 36, p. 1658-1659; operative 5-22-91 (Register 91, No. 27). A Certificate of Compliance must be transmitted to OAL by 9-19-91 or emergency language will be repealed by operation of law on the following day.
22. Amendment of subsections (a), (b), (c) and (d) refiled 9-19-91 as an emergency; operative 9-20-91 (Register 92, No. 4). A Certificate of Compliance must be transmitted to OAL 1-20-92 or emergency language will be repealed by operation of law on the following day.
23. Amendment of subsections (a), (b), (c) and (d) refiled 1-23-92 as an emergency; operative 1-17-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 5-22-92 or emergency language will be repealed by operation of law on the following day.
24. Certificate of Compliance as to 1-23-92 order including amendment of subsections (a)(2), (a)(10)-(11), (a)(13)-(14) and (d)(2) and NOTE transmitted to OAL 5-22-92 and filed 7-6-92 (Register 92, No. 28).
25. Amendment of subsections (b)(1), (b)(1)(B), (c) and (d)(1) and NOTE filed 1-6-94; operative 2-7-94 (Register 94, No. 1).
26. Amendment of subsections (a)(1)-(3), (a)(5), (a)(10)-(12), (b)-(b)(1), (b)(1)(B)-(b)(2)(A), (b)(3)-(b)(3)(A), (b)(4)-(b)(4)(A), (b)(5)-(b)(5)(A) and (c), repealer of subsections (a)(6)-(7) and (a)(17) filed 1-9-95; operative 3-1-95 (Register 95, No. 2).
27. Change without regulatory effect renumbering subsections filed 4-26-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 17).
28. Change without regulatory effect amending section and NOTE filed 1-26-2009 pursuant to section 100, title 1, California Code of Regulations except for subsection (a)(3) removing the definition of "drug product," a change that is exempt from review by OAL pursuant to Welfare and Institutions Code section 14105.45(f) (Register 2009, No. 5).
29. Editorial correction of HISTORY 28 (Register 2009, No. 11).

Note: Authority cited: Sections 20 and 208, Health and Safety Code; and Sections 10725, 14105, 14105.7 and 14124.5, Welfare and Institutions Code. Reference: Section 4211, Business and Professions Code; Sections 14105, 14105.7, 14105.35, 14105.45, 14132, 14133 and 14133.1, Welfare and Institutions Code; Fiscal Year 1989-90 Budget Act (Chapter 93, Statutes of 1989); 42 U.S.C. Section 1396a(a)(30)(A); and 42 C.F.R. Sections 447.301, 447.302, 447.304, 447.331, 447.332, 447.333 and 447.334.

1. Amendment of subsection (d) 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. For prior history, see Registers 83, No. 34; and 82, No. 49.
2. Amendment of subsections (a), (a)(10), (a)(12) and (a)(13) filed 10-3-84; effective thirtieth day thereafter (Register 84, No. 40).
3. Certificate of Compliance as to 8-1-84 order transmitted to OAL 11-27-84 and filed 12-27-84 (Register 84, No. 52).
4. Amendment of subsection (d) filed 1-31-85 as an emergency; designated effective 2-1-85 (Register 85, No. 5). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 6-1-85.
5. Certificate of Compliance transmitted to OAL 5-23-85 and filed 6-24-85 (Register 85, No. 26).
6. Amendment of subsection (d) 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.
7. Relettering of subsections (d)-(f) to subsections (e)-(g) and new subsection (d) filed 9-16-85 as an emergency; effective upon filing (Register 85, No. 39). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 1-14-86.
8. Certificate of Compliance as to 8-1-85 order transmitted to OAL 11-20-85 and filed 12-27-85 (Register 85, No. 52).
9. Certificate of Compliance as to 9-16-85 order transmitted to OAL 1-2-86 and filed 2-3-86 (Register 86, No. 7).
10. Amendment of subsections (a)(9), (a)(13), (b)(4) and (b)(5) filed 7-28-86; designated effective 9-1-86 (Register 86, No. 31).
11. Amendment of subsection (a)(13) filed 6-10-87; operative 7-10-87 (Register 87, No. 25).
12. Amendment of subsections (a)(12)-(14) filed 10-27-87 as an emergency; operative 10-29-87 (Register 87, No. 44). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 2-26-88.
13. Certificate of Compliance transmitted to OAL 2-24-88 and filed 3-25-88 (Register 88, No. 14).
14. Amendment of subsection (a)(8) filed 9-14-89 as an emergency; operative 10-16-89 (Register 89, No. 38). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 2-13-90.
15. Amendment of subsection (a)(8) refiled 2-13-90 as an emergency; operative 2-13-90 (Register 90, No. 9). A Certificate of Compliance must be transmitted to OAL within 120 days or emergency language will be repealed on 6-13-90.
16. Certificate of Compliance as to 2-13-90 order transmitted to OAL 6-8-90 and disapproved 7-9-90 (Register 90, No. 34).
17. Amendment of subsection (a)(8) refiled 7-12-90 as an emergency; operative 7-12-90 (Register 90, No. 34). A Certificate of Compliance must be transmitted to OAL by 11-9-90 or emergency language will be repealed by operation of law on the following day.
18. Amendment of subsection (a)(8) refiled 11-16-90 as an emergency; operative 11-16-90 (Register 90, No. 52). A Certificate of Compliance must be transmitted to OAL by 3-18-91 or emergency language will be repealed by operation of law on the following day.
19. Amendment of subsections (a) and (e), and Note filed 3-22-91; operative 4-21-91 (Register 91, No. 15).
20. Certificate of Compliance as to 11-16-90 order including amendment of NOTE transmitted to OAL 3-12-91 and filed 4-11-91 (Register 91, No. 17).
21. Amendment of subsections (a), (b), (c) and (d) and repealer of subsections (e) and (f) filed 5-22-91 as an emergency pursuant to Statutes of 1990, chapter 456, section 36, p. 1658-1659; operative 5-22-91 (Register 91, No. 27). A Certificate of Compliance must be transmitted to OAL by 9-19-91 or emergency language will be repealed by operation of law on the following day.
22. Amendment of subsections (a), (b), (c) and (d) refiled 9-19-91 as an emergency; operative 9-20-91 (Register 92, No. 4). A Certificate of Compliance must be transmitted to OAL 1-20-92 or emergency language will be repealed by operation of law on the following day.
23. Amendment of subsections (a), (b), (c) and (d) refiled 1-23-92 as an emergency; operative 1-17-92 (Register 92, No. 25). A Certificate of Compliance must be transmitted to OAL 5-22-92 or emergency language will be repealed by operation of law on the following day.
24. Certificate of Compliance as to 1-23-92 order including amendment of subsections (a)(2), (a)(10)-(11), (a)(13)-(14) and (d)(2) and Note transmitted to OAL 5-22-92 and filed 7-6-92 (Register 92, No. 28).
25. Amendment of subsections (b)(1), (b)(1)(B), (c) and (d)(1) and Note filed 1-6-94; operative 2-7-94 (Register 94, No. 1).
26. Amendment of subsections (a)(1)-(3), (a)(5), (a)(10)-(12), (b)-(b)(1), (b)(1)(B)-(b)(2)(A), (b)(3)-(b)(3)(A), (b)(4)-(b)(4)(A), (b)(5)-(b)(5)(A) and (c), repealer of subsections (a)(6)-(7) and (a)(17) filed 1-9-95; operative 3-1-95 (Register 95, No. 2).
27. Change without regulatory effect renumbering subsections filed 4-26-95 pursuant to section 100, title 1, California Code of Regulations (Register 95, No. 17).
28. Change without regulatory effect amending section and Note filed 1-26-2009 pursuant to section 100, title 1, California Code of Regulations except for subsection (a)(3) removing the definition of "drug product," a change that is exempt from review by OAL pursuant to Welfare and Institutions Code section 14105.45(f) (Register 2009, No. 5).
29. Editorial correction of History 28 (Register 2009, No. 11).