Cal. Code Regs. tit. 22 § 51315.2

Current through Register 2024 Notice Reg. No. 49, December 6, 2024
Section 51315.2 - Requirements Applicable to the Prior Authorization of Prosthetic Appliances and Services

Prosthetic appliances and services shall be authorized under the Medi-Cal program when supporting documentation and all other requirements specified in Section 51315 and in this section are met.

For purposes of this section, medical conditions cited with each appliance/service or group of appliances/services shall not be construed to represent an exhaustive list of medical conditions appropriate to each appliance/service or group of appliances/services. Likewise, such medical conditions may not be appropriate for authorization of the requested appliance/service if medical necessity for the specific appliance/service is not documented.

(a) Lower Limb Prostheses:
(1) Shall be authorized when the patient has a functional level of "one" or higher (potential for ambulation or other functional activites). Lower limb prostheses shall not be authorized when the patient has a functional level of "zero" (no potential for ambulation or other functional activites).
(2) Shall include all of the following:
(A) Partial Foot Prostheses shall be authorized when the patient has had an amputation of part or all of the foot and requires a definitive prosthesis to permit ambulation or other functional activities.
(B) Ankle Prostheses shall be authorized when the patient has had an amputation through or at the ankle, such as a Syme's procedure and requires a definitive prosthesis to permit ambulation or other functional activities.
(C) Below Knee Prostheses shall be authorized when the patient has had an amputation between the ankle and knee and requires an exoskeletal definitive prosthesis to permit ambulation or other functional activities.
(D) Knee Disarticulation Prostheses shall be authorized when the patient has had an amputation through or near the knee and requires an exoskeletal definitive prosthesis to permit ambulation or other functional activities.
(E) Above Knee Prostheses shall be authorized when the patient has had an amputation between the knee and hip and requires a definitive prosthesis to permit ambulation or other functional activities.
(F) Hip Disarticulation Prostheses shall be authorized when the patient has had an amputation through or near the hip and requires an exoskeletal definitive prosthesis to permit ambulation or other functional activities.
(G) Hemipelvectomy Prostheses shall be authorized when the patient has had an amputation with removal of half the pelvis and requires an exoskeletal definitive prosthesis to permit ambulation or other functional activities.
(H) Endoskeletal Prostheses shall be authorized when the patient has had a lower limb amputation and requires an endoskeletal definitive prosthesis to permit ambulation or other functional activities, appropriate to the requested procedure code(s).
(I) Immediate and Early Post Surgical Procedures shall be authorized when the patient has had a lower limb amputation and requires one or more of the following, appropriate to the requested procedure code(s):
1. A temporary prosthesis shall be authorized when it is applied soon after amputation before the original amputation wound or residual limb revision(s) wound has completely healed to permit some lower extremity function.
2. An additional cast change(s) and realignment(s) of the temporary prosthesis specified in paragraph 1. above shall be authorized when the patient has an existing or authorized temporary prosthesis that requires these services.
3. A temporary application of a non-weight bearing rigid dressing shall be authorized when it is applied soon after amputation before the original amputation wound or the residual limb revision(s) wound has completely healed, and when there is no expectation of use of a prosthesis until the wound has completely healed.
(J) Initial Prostheses shall be authorized when the patient has had a lower limb amputation that requires a temporary prosthesis, and when the prosthesis is applied after the original amputation wound or the residual limb revision(s) wound has healed but the residual limb has not reached its final shape, appropriate to the requested procedure code(s).
(K) Preparatory Prostheses -- Below Knee shall be authorized when the patient has had a below-the-knee amputation and requires a temporary prosthesis to permit some ambulation or other functional activities in preparation for the fitting of a definitive prosthesis, and when the prosthesis is applied after the original amputation wound or the residual limb revision(s) wound has healed but the residual limb has not reached its final shape.
(L) Preparatory Prostheses -- Above Knee shall be authorized when the patient has had an above-the-knee amputation and requires a temporary prosthesis to permit some ambulation or other functional activities in preparation for the fitting of a definitive prosthesis, and when the prosthesis is applied after the original amputation wound or the residual limb revision(s) wound has healed but the residual limb has not reached its final shape, appropriate to the requested procedure code(s).
(M) Additions to Lower Limb Prostheses:
1. Shall include all of the following:
a. Endoskeletal System -- Above Knee.
b. Test Sockets.
c. Socket Variations.
d. Socket Inserts.
e. Suspension -- Below Knee.
f. Suspension -- Above Knee.
g. Exoskeletal Knee-Shin System.
h. Endoskeletal Knee-Shin System.
i. Miscellaneous.
2. Shall be authorized when all of the following criteria are met:
a. The patient's medical condition requires the specific function for which the addition(s) was designed.
b. The addition(s) is required by the patient to improve the functionality of the prosthesis, without which the patient's medical need(s) would not be met.
c. The patient has an existing or authorized lower limb prosthesis that is compatible with the addition(s).
(N) Replacements -- Feet-Ankle Units shall be authorized when both of the following criteria are met:
1. The cost(s) of the replacement is less than the cost(s) of purchasing a new prosthesis.
2. The patient has an existing or authorized lower limb prosthesis that is compatible with the replacement(s).
(b) Upper Limb Prostheses shall include all of the following:
(1) Partial Hand Prostheses shall be authorized when the patient has had an amputation of part or all of the hand and requires a definitive prosthesis to permit functional use of the upper extremity, appropriate to the requested procedure code(s).
(2) Wrist Disarticulation Prostheses shall be authorized when the patient has had an amputation through or near the wrist and requires an exoskeletal definitive prosthesis to permit functional use of the upper extremity.
(3) Elbow Prostheses shall be authorized when the patient has had an amputation near the elbow and requires an exoskeletal definitive prosthesis to permit functional use of the upper extremity, appropriate to the requested procedure code(s).
(4) Shoulder Prostheses shall be authorized when the patient has had an amputation through or near the shoulder and requires an exoskeletal definitive prosthesis to permit functional use of the upper extremity.
(5) Interscapular Thoracic Prostheses shall be authorized when the patient has had an amputation with removal of both the shoulder joint and the scapula and requires an exoskeletal definitive prosthesis to permit functional use of the upper extremity.
(6) Immediate and Early Post Surgical Procedures shall be authorized when the patient has had an upper limb amputation and requires one or more of the following, appropriate to the requested procedure code(s):
(A) A temporary prosthesis shall be authorized when it is applied soon after amputation before the original amputation wound or the residual limb revision(s) wound has completely healed to permit some upper extremity function.
(B) An additional cast change(s) and realignment(s) of the temporary prosthesis specified in paragraph (A) above shall be authorized when the patient has an existing or authorized temporary prosthesis that requires these services.
(C) A temporary application of a non-weight bearing rigid dressing shall be authorized when it is applied soon after amputation before the original amputation wound or the residual limb revision(s) wound has completely healed, and when there is no expectation of use of a prosthesis until the wound has completely healed.
(7) Endoskeletal -- Elbow or Shoulder Area Prostheses shall be authorized when the patient has had an upper extremity amputation and requires a definitive prosthesis to permit functional use of the upper extremity, appropriate to the requested procedure code(s).
(8) Endoskeletal -- Interscapular Thoracic Prostheses shall be authorized when the patient has had an upper limb amputation and requires a temporary or preparatory prosthesis to permit some upper extremity function in preparation for the fitting of a definitive prosthesis; and when the prosthesis is applied after the original amputation wound or the residual limb revision(s) wound has healed but the residual limb has not reached its final shape, appropriate to the requested procedure code(s).
(9) Additions to Upper Limb Prostheses shall be authorized when all of the following criteria are met:
(A) The patient's medical condition requires the specific function for which the addition(s) was designed.
(B) The addition(s) is required by the patient to improve the functionality of the prosthesis, without which the patient's medical need(s) would not be met.
(C) The patient has an existing or authorized upper limb prosthesis that is compatible with the addition(s).
(10) Replacements for Upper Limb Prostheses shall be authorized when both of the following criteria are met:
(A) The cost(s) of the replacement is less than the cost(s) of purchasing a new prosthesis.
(B) The patient has an existing or authorized upper limb prosthesis that is compatible with the replacement(s).
(c) Terminal Devices shall include all of the following:
(1) Hooks shall include both the base appliance or device and any required addition(s) or attachment(s) and shall be authorized when one or both of the following criteria is met, appropriate to the requested procedure code(s):
(A) For the requested base appliance or device, both of the following criteria are met:
1. The patient requires a terminal device to permit functional use of the upper extremity.
2. The patient has an existing or authorized upper extremity prosthesis that is compatible with the terminal device.
(B) For the requested addition(s) or attachment(s), all of the following criteria are met:
1. The patient's medical condition requires the specific function for which the addition(s) or attachment(s) was designed.
2. The addition(s) or attachment(s) is required by the patient to improve the functionality of the terminal device, without which the patient's medical need(s) would not be met.
3. The patient has an existing or authorized terminal device that is compatible with the addition(s) or attachment(s).
(2) Hands shall include both the base appliance or device and any required addition(s) or attachment(s) and shall be authorized when one or both of the following criteria is met, appropriate to the requested procedure code(s):
(A) For the base appliance or device, both of the following criteria are met:
1. The patient requires a terminal device to permit functional use of the upper extremity.
2. The patient has an existing or authorized upper extremity prosthesis that is compatible with the terminal device.
(B) For the addition(s) or attachment(s), all of the following criteria are met:
1. The patient's medical condition requires the specific function for which the addition(s) or attachment(s) was designed.
2. The addition(s) or attachment(s) is required to improve the functionality of the terminal device, without which the patient's medical need(s) would not be met.
3. The patient has an existing or authorized terminal device that is compatible with the addition(s) or attachment(s).
(3) Hand Restoration Procedures shall include casts, shading and measurements and shall be authorized when one or more of the following criteria is met, appropriate to the requested procedure code(s):
(A) For the partial hand prosthesis, both of the following criteria are met:
1. The patient requires a partial hand prosthesis to permit functional use of the upper extremity.
2. The patient has an existing or authorized upper extremity prosthesis that is compatible with the partial hand prosthesis.
(B) For the replacement glove(s), both of the following criteria are met:
1. The patient requires a replacement glove(s) for a hand prosthesis.
2. The patient has an existing or authorized hand prosthesis that is compatible with the replacement glove(s).
(d) External Power shall include all of the following:
(1) Base Devices shall be authorized when both of the following criteria are met:
(A) The patient requires an upper extremity prosthesis with one or more electrically powered functional parts or electronic circuitry that is activated by the patient to allow effective movement of the upper extremity in the performance of activities of daily living and instrumental activities of daily living, appropriate to the requested procedure code(s).
(B) The patient is not able to otherwise effectively use a manually operated prosthesis.
(2) Terminal Devices shall be authorized when all of the following criteria are met:
(A) The patient requires a terminal device with one or more electrically powered functional parts or electronic circuitry that is activated by the patient to allow effective movement of the upper extremity in the performance of activities of daily living and instrumental activities of daily living, appropriate to the requested procedure code(s).
(B) The patient is not able to otherwise effectively use a manually operated prosthesis.
(C) The patient has an existing or authorized upper extremity prosthesis that is compatible with the terminal device.
(3) Elbow Attachments shall be authorized when all of the following criteria are met:
(A) The patient requires an elbow joint attachment with one or more electrically powered functional parts or electronic circuitry that is activated by the patient to allow effective movement of the upper extremity in the performance of activities of daily living and instrumental activities of daily living.
(B) The patient is not able to otherwise effectively use a manually operated prosthesis.
(C) The patient has an existing or authorized upper extremity prosthesis that is compatible with the elbow attachment.
(4) Control Modules and Battery Components shall be authorized when the patient has an existing or authorized upper extremity electrically powered prosthesis that requires a control module or battery component for functional use of the prosthesis.
(e) Breast Prostheses shall be authorized when the patient requires a prosthesis, component or attachment to replace a breast(s) after surgical removal, to support the surgical recovery or to hold the prosthesis in place.
(f) General Items shall include all of the following:
(1) Prosthetic Socks shall be authorized when both of the following criteria are met:
(A) The patient requires one or more of the following appliances, appropriate to the requested procedure code(s):
1. A prosthetic sheath that is placed over a residual limb and under a prosthetic sock while the prosthesis is being worn to decrease the irritation of the residual limb.
2. A prosthetic sock that is worn between the residual limb and the prosthesis to decrease the irritation of the residual limb.
3. A prosthetic shrinker that is worn over the residual limb to provide pressure against the residual limb to decrease accumulation of fluid in the residual limb.
4. A thinly woven sock that is used over the residual limb during the fitting of a prosthesis.
(B) The patient has an existing or authorized lower extremity prosthesis that is compatible with the prosthetic sheath, sock or shrinker.
(2) Repairs for Prosthetic Appliances shall include repairs, maintenance, replacements and associated labor and shall be authorized when all of the following criteria are met:
(A) The patient has an existing prosthesis that requires repair, maintenance or replacement.
(B) The repair, maintenance or replacement cost(s), including the associated labor is less than the cost(s) of purchasing a new prosthetic appliance.
(C) The request or claim includes a list of the components to be repaired or replaced and a statement explaining the necessity for the repair or replacement.
(g) Miscellaneous Prosthetic Appliances shall be authorized when the patient has had an amputation or removal of a body part and requires one or more of the following appliances or devices, appropriate to the requested procedure code(s):
(1) A prosthetic appliance or service that is not functionally equivalent to, or does not meet the descriptor for, an existing prosthetic appliance or service procedure code(s).
(2) A device to enable speaking in the absence of the larynx.
(3) A device to enable speaking with a tracheostomy.
(4) A replacement battery or accessory for an artificial larynx.
(5) A trachea-esophageal voice prosthesis.
(6) A voice amplifier.

Cal. Code Regs. Tit. 22, § 51315.2

1. New section filed 10-2-2015; operative 1-1-2016 (Register 2015, No. 40).

Note: Authority cited: Section 20, Health and Safety Code; and Sections 10725 and 14124.5, Welfare and Institutions Code. Reference: Sections 14103.7, 14105.21, 14132, 14133, 14133.1, 14133.3 and 14133.9, Welfare and Institutions Code.

1. New section filed 10-2-2015; operative 1/1/2016 (Register 2015, No. 40).