PA Lookup
If you have questions about prior authorizations, please call:
Member and Recipient Service Line: 1-877-685-2415
Provider Support Service Line: 1-855-250-1539
J2550 PROMETHAZINE HCI, UP TO 50 MG (PHENERGAN, ANERGAN 25, ANERGAN 50, PHENAZINE 25)
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
N/A - No authorization is required
J2560 PHENOBARBITAL SODIUM, UP TO 120 MG
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
N/A - No authorization is required
J2680 FLUPHENAZINE DECANOATE, UP TO 25 MG (PROLOXON DECANOATE)
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
N/A - No authorization is required
Dialysis Service
Dialysis Services are procedures and services for beneficiaries with chronic renal disease or acute kidney injury designed to replace the functioning of the kidney and maintain the function of related organs. Progressive chronic renal failure typically requires on going dialysis due to End Stage Renal Disease (ESRD), as a result of permanent loss of normal kidney tissues and function. Hemodialysis, peritoneal dialysis, and self-dialysis support services are covered, as outlined in this clinical policy, when they are provided by a Medicaid & Medicare certified ESRD hospital based renal dialysis center or free-standing ESRD facility for beneficiaries requiring dialysis services.
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
Limits
Hemodyalisis: Covered without documentation of medical necessity up to three times weekly. Cannot exceed more than one hemodialysis treatment per date of service.
For AKI dialysis treatments during the monthly billing cycle, only one payment for one treatment per day across settings is allowed; additional payment may be allowed for an uncompleted or partial treatment.
Providers shall document the first date of the ongoing dialysis treatment on each claim submitted.
Providers shall bill dialysis-related services once per calendar month using the last day of the month as the date of service.
If the beneficiary dies before month-end, use the date of death or the last date seen instead of the last day of the month.
Hemodialysis training is reimbursed in sessions that can last up to five hours per day.
Peritoneal Dialysis: Covered when provided by a Medicaid & Medicare certified ESRD hospital-based renal dialysis center or free-standing ESRD facility.
CAPD and CCPD are covered per date of service, not per treatment.
Providers shall bill dialysis-related services once per calendar month, using the last day of the month as the date of service.
Dialysis training is typically completed within two weeks of initiating self-care.
CAPD training sessions can last up to eight hours per day.
CCPD training sessions can last up to eight hours per day.
Home dialysis is performed at home by an ESRD beneficiary or private caregiver who has completed appropriate training.
Self Dialysis: Self-dialysis may be performed only in CMS-compliant centers or in the ESRD beneficiary's private primary residence.
Little or no professional assistance is provided except in an emergency.
Dialysis training is typically completed within two weeks of initiating self-care.
Hemodialysis training sessions can last up to 5 hours per day.
Reimbursement for the completed course is allowed once per beneficiary's lifetime.
Dialysis training sessions are limited to 25 sessions per beneficiary's lifetime.
Training and retraining sessions are reimbursed at the same rate.
Exclusions
Home dialysis is not covered for beneficiaries diagnosed with acute kidney injury because they require close medical supervision.
For undocumented aliens, dialysis is covered only as an emergency service in a facility with licensed professional monitoring during each episode of care; once the beneficiary is stable enough for in-home hemodialysis without immediate medical attention, the treatment is no longer an emergency service.
Medicaid shall not cover the following Dialysis Services:
- a. office visits, home visits, consults and care plan oversight included in the
monthly capitation;
- b. access maintenance performed by the staff in the ESRD facility;
- c. take home drugs and supplies;
- d. specimen collection fees;
- e. transportation: The beneficiary is encouraged to contact their local county
Department of Social Services for assistance;
- f. medical supply charges, including syringes and their administration;
- g. costs associated with a private caregiver, outside of allowed training paid to
the training facility; and
- h. capitation payment for the month in which the training code is billed.
Note: When a beneficiary becomes eligible for Medicare or another third-party payer, Medicaid cannot be billed as the primary payer.
Federal Qualified Health Centers and Rural Health Clinics may not provide dialysis services or any dialysis related services.
Place of Service
Home, ESRD facilities, and independent laboratories. Telehealth claims should be filed with the provider's usual place of services code(s). Co-payments Monthly co-payments are required for Dialysis Services.
How to Submit
N/A - No authorization is required
Resources
Dialysis Service
Dialysis Services are procedures and services for beneficiaries with chronic renal disease or acute kidney injury designed to replace the functioning of the kidney and maintain the function of related organs. Progressive chronic renal failure typically requires on going dialysis due to End Stage Renal Disease (ESRD), as a result of permanent loss of normal kidney tissues and function. Hemodialysis, peritoneal dialysis, and self-dialysis support services are covered, as outlined in this clinical policy, when they are provided by a Medicaid & Medicare certified ESRD hospital based renal dialysis center or free-standing ESRD facility for beneficiaries requiring dialysis services.
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
Limits
Hemodyalisis: Covered without documentation of medical necessity up to three times weekly. Cannot exceed more than one hemodialysis treatment per date of service.
For AKI dialysis treatments during the monthly billing cycle, only one payment for one treatment per day across settings is allowed; additional payment may be allowed for an uncompleted or partial treatment.
Providers shall document the first date of the ongoing dialysis treatment on each claim submitted.
Providers shall bill dialysis-related services once per calendar month using the last day of the month as the date of service.
If the beneficiary dies before month-end, use the date of death or the last date seen instead of the last day of the month.
Hemodialysis training is reimbursed in sessions that can last up to five hours per day.
Peritoneal Dialysis: Covered when provided by a Medicaid & Medicare certified ESRD hospital-based renal dialysis center or free-standing ESRD facility.
CAPD and CCPD are covered per date of service, not per treatment.
Providers shall bill dialysis-related services once per calendar month, using the last day of the month as the date of service.
Dialysis training is typically completed within two weeks of initiating self-care.
CAPD training sessions can last up to eight hours per day.
CCPD training sessions can last up to eight hours per day.
Home dialysis is performed at home by an ESRD beneficiary or private caregiver who has completed appropriate training.
Self Dialysis: Self-dialysis may be performed only in CMS-compliant centers or in the ESRD beneficiary's private primary residence.
Little or no professional assistance is provided except in an emergency.
Dialysis training is typically completed within two weeks of initiating self-care.
Hemodialysis training sessions can last up to 5 hours per day.
Reimbursement for the completed course is allowed once per beneficiary's lifetime.
Dialysis training sessions are limited to 25 sessions per beneficiary's lifetime.
Training and retraining sessions are reimbursed at the same rate.
Exclusions
Home dialysis is not covered for beneficiaries diagnosed with acute kidney injury because they require close medical supervision.
For undocumented aliens, dialysis is covered only as an emergency service in a facility with licensed professional monitoring during each episode of care; once the beneficiary is stable enough for in-home hemodialysis without immediate medical attention, the treatment is no longer an emergency service.
Medicaid shall not cover the following Dialysis Services:
- a. office visits, home visits, consults and care plan oversight included in the
monthly capitation;
- b. access maintenance performed by the staff in the ESRD facility;
- c. take home drugs and supplies;
- d. specimen collection fees;
- e. transportation: The beneficiary is encouraged to contact their local county
Department of Social Services for assistance;
- f. medical supply charges, including syringes and their administration;
- g. costs associated with a private caregiver, outside of allowed training paid to
the training facility; and
- h. capitation payment for the month in which the training code is billed.
Note: When a beneficiary becomes eligible for Medicare or another third-party payer, Medicaid cannot be billed as the primary payer.
Federal Qualified Health Centers and Rural Health Clinics may not provide dialysis services or any dialysis related services.
Place of Service
Home, ESRD facilities, and independent laboratories. Telehealth claims should be filed with the provider's usual place of services code(s). Co-payments Monthly co-payments are required for Dialysis Services.
How to Submit
N/A - No authorization is required
Resources
Dialysis Service
Dialysis Services are procedures and services for beneficiaries with chronic renal disease or acute kidney injury designed to replace the functioning of the kidney and maintain the function of related organs. Progressive chronic renal failure typically requires on going dialysis due to End Stage Renal Disease (ESRD), as a result of permanent loss of normal kidney tissues and function. Hemodialysis, peritoneal dialysis, and self-dialysis support services are covered, as outlined in this clinical policy, when they are provided by a Medicaid & Medicare certified ESRD hospital based renal dialysis center or free-standing ESRD facility for beneficiaries requiring dialysis services.
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
Limits
Hemodyalisis: Covered without documentation of medical necessity up to three times weekly. Cannot exceed more than one hemodialysis treatment per date of service.
For AKI dialysis treatments during the monthly billing cycle, only one payment for one treatment per day across settings is allowed; additional payment may be allowed for an uncompleted or partial treatment.
Providers shall document the first date of the ongoing dialysis treatment on each claim submitted.
Providers shall bill dialysis-related services once per calendar month using the last day of the month as the date of service.
If the beneficiary dies before month-end, use the date of death or the last date seen instead of the last day of the month.
Hemodialysis training is reimbursed in sessions that can last up to five hours per day.
Peritoneal Dialysis: Covered when provided by a Medicaid & Medicare certified ESRD hospital-based renal dialysis center or free-standing ESRD facility.
CAPD and CCPD are covered per date of service, not per treatment.
Providers shall bill dialysis-related services once per calendar month, using the last day of the month as the date of service.
Dialysis training is typically completed within two weeks of initiating self-care.
CAPD training sessions can last up to eight hours per day.
CCPD training sessions can last up to eight hours per day.
Home dialysis is performed at home by an ESRD beneficiary or private caregiver who has completed appropriate training.
Self Dialysis: Self-dialysis may be performed only in CMS-compliant centers or in the ESRD beneficiary's private primary residence.
Little or no professional assistance is provided except in an emergency.
Dialysis training is typically completed within two weeks of initiating self-care.
Hemodialysis training sessions can last up to 5 hours per day.
Reimbursement for the completed course is allowed once per beneficiary's lifetime.
Dialysis training sessions are limited to 25 sessions per beneficiary's lifetime.
Training and retraining sessions are reimbursed at the same rate.
Exclusions
Home dialysis is not covered for beneficiaries diagnosed with acute kidney injury because they require close medical supervision.
For undocumented aliens, dialysis is covered only as an emergency service in a facility with licensed professional monitoring during each episode of care; once the beneficiary is stable enough for in-home hemodialysis without immediate medical attention, the treatment is no longer an emergency service.
Medicaid shall not cover the following Dialysis Services:
- a. office visits, home visits, consults and care plan oversight included in the
monthly capitation;
- b. access maintenance performed by the staff in the ESRD facility;
- c. take home drugs and supplies;
- d. specimen collection fees;
- e. transportation: The beneficiary is encouraged to contact their local county
Department of Social Services for assistance;
- f. medical supply charges, including syringes and their administration;
- g. costs associated with a private caregiver, outside of allowed training paid to
the training facility; and
- h. capitation payment for the month in which the training code is billed.
Note: When a beneficiary becomes eligible for Medicare or another third-party payer, Medicaid cannot be billed as the primary payer.
Federal Qualified Health Centers and Rural Health Clinics may not provide dialysis services or any dialysis related services.
Place of Service
Home, ESRD facilities, and independent laboratories. Telehealth claims should be filed with the provider's usual place of services code(s). Co-payments Monthly co-payments are required for Dialysis Services.
How to Submit
N/A - No authorization is required
Resources
J2765 METOCLOPRAMIDE HCL, UP TO 10 MG (REGLAN)
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
N/A - No authorization is required
J2794 INJECTION, RISPERIDONE, LONG ACTING, 0.5 MG(RISPERDAL CONSTA)
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
N/A - No authorization is required
J2930 METHYLPREDNISOLONE SODIUM SUCCINATE, UP TO 125 MG
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
N/A - No authorization is required
J3360 DIAZEPAM, UP TO 5 MG (VALIUM, ZETRAN)
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
N/A - No authorization is required
Cell & Gene Therapies
Human gene therapy aims to manipulate gene expression or alter cellular properties for therapeutic purposes. Gene therapy involves modifying a beneficiary’s genetic makeup to combat or eradicate diseases. This can be achieved through various methods: a. Replacement of a defective gene with a healthy version; b. Deactivation of a malfunctioning gene; or c. Introduction of a new or modified gene to address a specific condition.
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
Conditional Requirements
Prior authorization may be required. Check North Carolina clinical coverage policy 1S-10, Genetic Testing for Carrier and Prenatal for more information
Limits
Medicaid shall not cover Cell & Gene Therapies for ANY one of the following:
- a. The Cell or Gene Therapy has not received approval from the U.S. FDA;
- b. The Cell or Gene Therapy is being administered outside the U.S. FDA label regarding:
- 1. Indications and usage;
- 2. Dosage and administration; or
- 3. Dosage forms and strengths;
- c. The Cell or Gene Therapy is being administered at a facility that has not been approved as a QTC or ATC for that therapy, when required by the manufacturer;
- d. Repeat treatment in a beneficiary who has received the same or another Cell or Gene Therapy previously, except for therapies that require multiple infusions or doses as part of a single treatment course;
- e. When the beneficiary’s psychosocial history limits the beneficiary’s ability to comply with pre- and post-infusion medical care; or
- f. When there is current beneficiary or caretaker non-compliance that would make compliance with a disciplined medical regime improbable.
Medicaid shall also not cover:
- a. Fertility preservation services associated with Cell & Gene Therapy
administration; and
- b. Non-Emergency Medical Transportation (NEMT) for fertility preservation
service appointments.
Exclusions
One-time, lifetime treatment; continued therapy is not authorized, except that some therapies may require multiple infusions or doses as part of a single treatment course.
Administration is limited to inpatient or outpatient settings.
For this State-Selected Model Drug, a provider submitting a claim for a Model Beneficiary must be registered with the CMS-designated patient registry and must seek beneficiary consent for participation in a CMS-specified study.
Payment is contingent on continued compliance with CGT Access Model requirements.
Diagnosis Requirements
This service falls under the cell and gene therapy policy, which is directed to FDA-approved gene therapies and, within the CMS CGT Access Model definitions, to FDA-approved gene therapy for sickle cell disease. Exagamglogene autotemcel is identified by NC Medicaid as a State-Selected Model Drug under the CGT Access Model. A Candidate Beneficiary must have a documented medical diagnosis of sickle cell disease, and Medicaid coverage requires the service to be medically necessary, individualized, specific, and consistent with symptoms or a confirmed diagnosis, safely furnished, and not primarily for convenience. Specific coverage criteria require that the therapy be FDA approved, administered in accordance with the FDA-approved label for indications and usage, dosage and administration, dosage forms and strengths, and warnings and precautions, and administered at a manufacturer-approved QTC or ATC if required. If specific PA criteria exist, those criteria take precedence over the FDA label; otherwise, the FDA label governs.
Place of Service
Inpatient, Outpatient.
How to Submit
Authorization Conditionally Required – See the conditional prior authorization requirements before continuing to the Trillium request form (iTransact for TP Medicaid members and Provider Direct for MCD Direct members), if applicable
Resources
Cell & Gene Therapies
Human gene therapy aims to manipulate gene expression or alter cellular properties for therapeutic purposes. Gene therapy involves modifying a beneficiary’s genetic makeup to combat or eradicate diseases. This can be achieved through various methods: a. Replacement of a defective gene with a healthy version; b. Deactivation of a malfunctioning gene; or c. Introduction of a new or modified gene to address a specific condition.
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
Conditional Requirements
Prior authorization may be required. Check North Carolina clinical coverage policy 1S-10, Genetic Testing for Carrier and Prenatal for more information
Limits
Medicaid shall not cover Cell & Gene Therapies for ANY one of the following:
- a. The Cell or Gene Therapy has not received approval from the U.S. FDA;
- b. The Cell or Gene Therapy is being administered outside the U.S. FDA label regarding:
- 1. Indications and usage;
- 2. Dosage and administration; or
- 3. Dosage forms and strengths;
- c. The Cell or Gene Therapy is being administered at a facility that has not been approved as a QTC or ATC for that therapy, when required by the manufacturer;
- d. Repeat treatment in a beneficiary who has received the same or another Cell or Gene Therapy previously, except for therapies that require multiple infusions or doses as part of a single treatment course;
- e. When the beneficiary’s psychosocial history limits the beneficiary’s ability to comply with pre- and post-infusion medical care; or
- f. When there is current beneficiary or caretaker non-compliance that would make compliance with a disciplined medical regime improbable.
Medicaid shall also not cover:
- a. Fertility preservation services associated with Cell & Gene Therapy
administration; and
- b. Non-Emergency Medical Transportation (NEMT) for fertility preservation
service appointments.
Exclusions
Billed per treatment.
Administration is limited to inpatient or outpatient settings.
Continued therapy is not authorized because cell and gene therapy is intended as a one-time, lifetime treatment, although some therapies may involve multiple infusions or doses within a single treatment course. It is not covered if the therapy has not received U.S. FDA approval, is administered outside the U.S. FDA label for indications and usage, dosage and administration, or dosage forms and strengths, or is administered at a facility not approved as a Qualified Treatment Center or Authorized Treatment Center when manufacturer approval is required. Repeat treatment after a beneficiary has previously received the same or another cell or gene therapy is not covered, except where multiple infusions or doses are part of a single treatment course. Coverage is also excluded when psychosocial history limits the beneficiary's ability to comply with pre- and post-infusion medical care, or when current beneficiary or caretaker non-compliance makes compliance with a disciplined medical regimen improbable. Fertility preservation services associated with cell and gene therapy administration, and NEMT for fertility preservation appointments, are not covered.
Diagnosis Requirements
This service falls under the cell and gene therapy policy, which is directed to FDA-approved gene therapies and, within the CMS CGT Access Model definitions, to FDA-approved gene therapy for sickle cell disease. Exagamglogene autotemcel is identified by NC Medicaid as a State-Selected Model Drug under the CGT Access Model. A Candidate Beneficiary must have a documented medical diagnosis of sickle cell disease, and Medicaid coverage requires the service to be medically necessary, individualized, specific, and consistent with symptoms or a confirmed diagnosis, safely furnished, and not primarily for convenience. Specific coverage criteria require that the therapy be FDA approved, administered in accordance with the FDA-approved label for indications and usage, dosage and administration, dosage forms and strengths, and warnings and precautions, and administered at a manufacturer-approved QTC or ATC if required. If specific PA criteria exist, those criteria take precedence over the FDA label; otherwise, the FDA label governs.
Place of Service
Inpatient, Outpatient.
How to Submit
Authorization Conditionally Required – See the conditional prior authorization requirements before continuing to the Trillium request form (iTransact for TP Medicaid members and Provider Direct for MCD Direct members), if applicable
Resources
Cell & Gene Therapies
Human gene therapy aims to manipulate gene expression or alter cellular properties for therapeutic purposes. Gene therapy involves modifying a beneficiary’s genetic makeup to combat or eradicate diseases. This can be achieved through various methods: a. Replacement of a defective gene with a healthy version; b. Deactivation of a malfunctioning gene; or c. Introduction of a new or modified gene to address a specific condition.
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
Conditional Requirements
Prior authorization may be required. Check North Carolina clinical coverage policy 1S-10, Genetic Testing for Carrier and Prenatal for more information
Limits
Medicaid shall not cover Cell & Gene Therapies for ANY one of the following:
- a. The Cell or Gene Therapy has not received approval from the U.S. FDA;
- b. The Cell or Gene Therapy is being administered outside the U.S. FDA label regarding:
- 1. Indications and usage;
- 2. Dosage and administration; or
- 3. Dosage forms and strengths;
- c. The Cell or Gene Therapy is being administered at a facility that has not been approved as a QTC or ATC for that therapy, when required by the manufacturer;
- d. Repeat treatment in a beneficiary who has received the same or another Cell or Gene Therapy previously, except for therapies that require multiple infusions or doses as part of a single treatment course;
- e. When the beneficiary’s psychosocial history limits the beneficiary’s ability to comply with pre- and post-infusion medical care; or
- f. When there is current beneficiary or caretaker non-compliance that would make compliance with a disciplined medical regime improbable.
Medicaid shall also not cover:
- a. Fertility preservation services associated with Cell & Gene Therapy
administration; and
- b. Non-Emergency Medical Transportation (NEMT) for fertility preservation
service appointments.
Exclusions
Billed per treatment.
Administration is limited to inpatient or outpatient settings.
Continued therapy is not authorized because cell and gene therapy is intended as a one-time, lifetime treatment, although some therapies may involve multiple infusions or doses within a single treatment course. It is not covered if the therapy has not received U.S. FDA approval, is administered outside the U.S. FDA label for indications and usage, dosage and administration, or dosage forms and strengths, or is administered at a facility not approved as a Qualified Treatment Center or Authorized Treatment Center when manufacturer approval is required. Repeat treatment after a beneficiary has previously received the same or another cell or gene therapy is not covered, except where multiple infusions or doses are part of a single treatment course. Coverage is also excluded when psychosocial history limits the beneficiary's ability to comply with pre- and post-infusion medical care, or when current beneficiary or caretaker non-compliance makes compliance with a disciplined medical regimen improbable. Fertility preservation services associated with cell and gene therapy administration, and NEMT for fertility preservation appointments, are not covered.
Diagnosis Requirements
This service falls under the cell and gene therapy policy, which is directed to FDA-approved gene therapies and, within the CMS CGT Access Model definitions, to FDA-approved gene therapy for sickle cell disease. Exagamglogene autotemcel is identified by NC Medicaid as a State-Selected Model Drug under the CGT Access Model. A Candidate Beneficiary must have a documented medical diagnosis of sickle cell disease, and Medicaid coverage requires the service to be medically necessary, individualized, specific, and consistent with symptoms or a confirmed diagnosis, safely furnished, and not primarily for convenience. Specific coverage criteria require that the therapy be FDA approved, administered in accordance with the FDA-approved label for indications and usage, dosage and administration, dosage forms and strengths, and warnings and precautions, and administered at a manufacturer-approved QTC or ATC if required. If specific PA criteria exist, those criteria take precedence over the FDA label; otherwise, the FDA label governs.
Place of Service
Inpatient, Outpatient.
How to Submit
Authorization Conditionally Required – See the conditional prior authorization requirements before continuing to the Trillium request form (iTransact for TP Medicaid members and Provider Direct for MCD Direct members), if applicable
Resources
Ocular Photodynamic Therapy
Ocular photodynamic therapy (OPT) is a treatment approved by the Food and Drug Administration for age-related macular degeneration (AMD), pathologic myopia, and ocular histoplasmosis. OPT is a two-step procedure involving the intravenous injection verteporfin (Visudyne®), a photosensitive drug. After injection, the verteporfin is activated by illumination with a non-thermal laser light at the wavelength that corresponds to the absorption peak of the drug. The light reacts with the photosensitive chemical in verteporfin, and the abnormal vessels are destroyed with no damage to the normal ones.
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
Limits
Beneficiaries may receive up to five treatments per eye per year with a maximum of ten treatments per eye during a 2-year-period.
Separate reimbursement is not allowed for intravenous infusion services.
Providers must maintain documentation including fluorescein angiogram and submit to NC Medicaid or its fiscal agent upon request.
Place of Service
Inpatient, Outpatient, Office
How to Submit
N/A - No authorization is required
Resources
Cell & Gene Therapies
Human gene therapy aims to manipulate gene expression or alter cellular properties for therapeutic purposes. Gene therapy involves modifying a beneficiary’s genetic makeup to combat or eradicate diseases. This can be achieved through various methods: a. Replacement of a defective gene with a healthy version; b. Deactivation of a malfunctioning gene; or c. Introduction of a new or modified gene to address a specific condition.
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
Conditional Requirements
Prior authorization may be required. Check North Carolina clinical coverage policy 1S-10, Genetic Testing for Carrier and Prenatal for more information
Limits
Medicaid shall not cover Cell & Gene Therapies for ANY one of the following:
- a. The Cell or Gene Therapy has not received approval from the U.S. FDA;
- b. The Cell or Gene Therapy is being administered outside the U.S. FDA label regarding:
- 1. Indications and usage;
- 2. Dosage and administration; or
- 3. Dosage forms and strengths;
- c. The Cell or Gene Therapy is being administered at a facility that has not been approved as a QTC or ATC for that therapy, when required by the manufacturer;
- d. Repeat treatment in a beneficiary who has received the same or another Cell or Gene Therapy previously, except for therapies that require multiple infusions or doses as part of a single treatment course;
- e. When the beneficiary’s psychosocial history limits the beneficiary’s ability to comply with pre- and post-infusion medical care; or
- f. When there is current beneficiary or caretaker non-compliance that would make compliance with a disciplined medical regime improbable.
Medicaid shall also not cover:
- a. Fertility preservation services associated with Cell & Gene Therapy
administration; and
- b. Non-Emergency Medical Transportation (NEMT) for fertility preservation
service appointments.
Exclusions
Billed per treatment.
Administration is limited to inpatient or outpatient settings.
Continued therapy is not authorized because cell and gene therapy is intended as a one-time, lifetime treatment, although some therapies may involve multiple infusions or doses within a single treatment course. It is not covered if the therapy has not received U.S. FDA approval, is administered outside the U.S. FDA label for indications and usage, dosage and administration, or dosage forms and strengths, or is administered at a facility not approved as a Qualified Treatment Center or Authorized Treatment Center when manufacturer approval is required. Repeat treatment after a beneficiary has previously received the same or another cell or gene therapy is not covered, except where multiple infusions or doses are part of a single treatment course. Coverage is also excluded when psychosocial history limits the beneficiary's ability to comply with pre- and post-infusion medical care, or when current beneficiary or caretaker non-compliance makes compliance with a disciplined medical regimen improbable. Fertility preservation services associated with cell and gene therapy administration, and NEMT for fertility preservation appointments, are not covered.
Diagnosis Requirements
This service falls under the cell and gene therapy policy, which is directed to FDA-approved gene therapies and, within the CMS CGT Access Model definitions, to FDA-approved gene therapy for sickle cell disease. Exagamglogene autotemcel is identified by NC Medicaid as a State-Selected Model Drug under the CGT Access Model. A Candidate Beneficiary must have a documented medical diagnosis of sickle cell disease, and Medicaid coverage requires the service to be medically necessary, individualized, specific, and consistent with symptoms or a confirmed diagnosis, safely furnished, and not primarily for convenience. Specific coverage criteria require that the therapy be FDA approved, administered in accordance with the FDA-approved label for indications and usage, dosage and administration, dosage forms and strengths, and warnings and precautions, and administered at a manufacturer-approved QTC or ATC if required. If specific PA criteria exist, those criteria take precedence over the FDA label; otherwise, the FDA label governs.
Place of Service
Inpatient, Outpatient.
How to Submit
Authorization Conditionally Required – See the conditional prior authorization requirements before continuing to the Trillium request form (iTransact for TP Medicaid members and Provider Direct for MCD Direct members), if applicable
Resources
Cell & Gene Therapies
Human gene therapy aims to manipulate gene expression or alter cellular properties for therapeutic purposes. Gene therapy involves modifying a beneficiary’s genetic makeup to combat or eradicate diseases. This can be achieved through various methods: a. Replacement of a defective gene with a healthy version; b. Deactivation of a malfunctioning gene; or c. Introduction of a new or modified gene to address a specific condition.
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
Conditional Requirements
Prior authorization may be required. Check North Carolina clinical coverage policy 1S-10, Genetic Testing for Carrier and Prenatal for more information
Limits
Medicaid shall not cover Cell & Gene Therapies for ANY one of the following:
- a. The Cell or Gene Therapy has not received approval from the U.S. FDA;
- b. The Cell or Gene Therapy is being administered outside the U.S. FDA label regarding:
- 1. Indications and usage;
- 2. Dosage and administration; or
- 3. Dosage forms and strengths;
- c. The Cell or Gene Therapy is being administered at a facility that has not been approved as a QTC or ATC for that therapy, when required by the manufacturer;
- d. Repeat treatment in a beneficiary who has received the same or another Cell or Gene Therapy previously, except for therapies that require multiple infusions or doses as part of a single treatment course;
- e. When the beneficiary’s psychosocial history limits the beneficiary’s ability to comply with pre- and post-infusion medical care; or
- f. When there is current beneficiary or caretaker non-compliance that would make compliance with a disciplined medical regime improbable.
Medicaid shall also not cover:
- a. Fertility preservation services associated with Cell & Gene Therapy
administration; and
- b. Non-Emergency Medical Transportation (NEMT) for fertility preservation
service appointments.
Exclusions
Billed per treatment.
Administration is limited to inpatient or outpatient settings.
Continued therapy is not authorized because cell and gene therapy is intended as a one-time, lifetime treatment, although some therapies may involve multiple infusions or doses within a single treatment course. It is not covered if the therapy has not received U.S. FDA approval, is administered outside the U.S. FDA label for indications and usage, dosage and administration, or dosage forms and strengths, or is administered at a facility not approved as a Qualified Treatment Center or Authorized Treatment Center when manufacturer approval is required. Repeat treatment after a beneficiary has previously received the same or another cell or gene therapy is not covered, except where multiple infusions or doses are part of a single treatment course. Coverage is also excluded when psychosocial history limits the beneficiary's ability to comply with pre- and post-infusion medical care, or when current beneficiary or caretaker non-compliance makes compliance with a disciplined medical regimen improbable. Fertility preservation services associated with cell and gene therapy administration, and NEMT for fertility preservation appointments, are not covered.
Diagnosis Requirements
This service falls under the cell and gene therapy policy, which is directed to FDA-approved gene therapies and, within the CMS CGT Access Model definitions, to FDA-approved gene therapy for sickle cell disease. Exagamglogene autotemcel is identified by NC Medicaid as a State-Selected Model Drug under the CGT Access Model. A Candidate Beneficiary must have a documented medical diagnosis of sickle cell disease, and Medicaid coverage requires the service to be medically necessary, individualized, specific, and consistent with symptoms or a confirmed diagnosis, safely furnished, and not primarily for convenience. Specific coverage criteria require that the therapy be FDA approved, administered in accordance with the FDA-approved label for indications and usage, dosage and administration, dosage forms and strengths, and warnings and precautions, and administered at a manufacturer-approved QTC or ATC if required. If specific PA criteria exist, those criteria take precedence over the FDA label; otherwise, the FDA label governs.
Place of Service
Inpatient, Outpatient.
How to Submit
Authorization Conditionally Required – See the conditional prior authorization requirements before continuing to the Trillium request form (iTransact for TP Medicaid members and Provider Direct for MCD Direct members), if applicable
Resources
Dialysis Service
Dialysis Services are procedures and services for beneficiaries with chronic renal disease or acute kidney injury designed to replace the functioning of the kidney and maintain the function of related organs. Progressive chronic renal failure typically requires on going dialysis due to End Stage Renal Disease (ESRD), as a result of permanent loss of normal kidney tissues and function. Hemodialysis, peritoneal dialysis, and self-dialysis support services are covered, as outlined in this clinical policy, when they are provided by a Medicaid & Medicare certified ESRD hospital based renal dialysis center or free-standing ESRD facility for beneficiaries requiring dialysis services.
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
Limits
Hemodyalisis: Covered without documentation of medical necessity up to three times weekly. Cannot exceed more than one hemodialysis treatment per date of service.
For AKI dialysis treatments during the monthly billing cycle, only one payment for one treatment per day across settings is allowed; additional payment may be allowed for an uncompleted or partial treatment.
Providers shall document the first date of the ongoing dialysis treatment on each claim submitted.
Providers shall bill dialysis-related services once per calendar month using the last day of the month as the date of service.
If the beneficiary dies before month-end, use the date of death or the last date seen instead of the last day of the month.
Hemodialysis training is reimbursed in sessions that can last up to five hours per day.
Peritoneal Dialysis: Covered when provided by a Medicaid & Medicare certified ESRD hospital-based renal dialysis center or free-standing ESRD facility.
CAPD and CCPD are covered per date of service, not per treatment.
Providers shall bill dialysis-related services once per calendar month, using the last day of the month as the date of service.
Dialysis training is typically completed within two weeks of initiating self-care.
CAPD training sessions can last up to eight hours per day.
CCPD training sessions can last up to eight hours per day.
Home dialysis is performed at home by an ESRD beneficiary or private caregiver who has completed appropriate training.
Self Dialysis: Self-dialysis may be performed only in CMS-compliant centers or in the ESRD beneficiary's private primary residence.
Little or no professional assistance is provided except in an emergency.
Dialysis training is typically completed within two weeks of initiating self-care.
Hemodialysis training sessions can last up to 5 hours per day.
Reimbursement for the completed course is allowed once per beneficiary's lifetime.
Dialysis training sessions are limited to 25 sessions per beneficiary's lifetime.
Training and retraining sessions are reimbursed at the same rate.
Exclusions
Home dialysis is not covered for beneficiaries diagnosed with acute kidney injury because they require close medical supervision.
For undocumented aliens, dialysis is covered only as an emergency service in a facility with licensed professional monitoring during each episode of care; once the beneficiary is stable enough for in-home hemodialysis without immediate medical attention, the treatment is no longer an emergency service.
Medicaid shall not cover the following Dialysis Services:
- a. office visits, home visits, consults and care plan oversight included in the
monthly capitation;
- b. access maintenance performed by the staff in the ESRD facility;
- c. take home drugs and supplies;
- d. specimen collection fees;
- e. transportation: The beneficiary is encouraged to contact their local county
Department of Social Services for assistance;
- f. medical supply charges, including syringes and their administration;
- g. costs associated with a private caregiver, outside of allowed training paid to
the training facility; and
- h. capitation payment for the month in which the training code is billed.
Note: When a beneficiary becomes eligible for Medicare or another third-party payer, Medicaid cannot be billed as the primary payer.
Federal Qualified Health Centers and Rural Health Clinics may not provide dialysis services or any dialysis related services.
Place of Service
Home, ESRD facilities, and independent laboratories. Telehealth claims should be filed with the provider's usual place of services code(s). Co-payments Monthly co-payments are required for Dialysis Services.
How to Submit
N/A - No authorization is required
Resources
J3411 INJECTION, THIAMINE HCL, 100 MG
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
N/A - No authorization is required
J3475 INJECTION, MAGNESIUM SULFATE, PER 500 MG
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
N/A - No authorization is required
J3486 INJECTION, ZIPRASIDONE MESYLATE, 10 MG
Authorization Guidelines
Please submit any records and any other information that you believe support the member has met the applicable medical necessity criteria to Trillium.
How to Submit
N/A - No authorization is required
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