Notification



Notification Issue Date:



Claim Payment Policy


Title:Self-Administered Drugs

Policy #:08.00.78aa

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.

Application of Claim Payment Policy is determined by benefits and contracts. Benefits may vary based on product line, group or contract. Medical necessity determination applies only if the benefit exists and no contract exclusions are applicable. Individual member benefits must be verified.

In products where members are able to self-refer to providers for care and services, members are advised to use participating providers in order to receive the highest level of benefits.When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

For more information on how Claim Payment Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

For most of the Company's commercial products, self-administered drugs are not covered under the member's medical benefit and, therefore, are not eligible for reimbursement under the member's medical benefit. Coverage may be available under the pharmacy benefit or through a pharmacy vendor. Individual benefits must be verified.

The codes listed in Attachment A of this policy represent the products that the Company considers to meet the definition of self-administered drugs. These drugs are not eligible for reimbursement consideration under the member's medical benefit even if the drugs are provided or administered by a professional provider (for some products, there may be exceptions relating to coagulation factors for hemophilia and other bleeding conditions [please refer to Coagulation Factors Medical Policy 08.00.92]). Additionally, drugs may be considered self-administered by the Company even in circumstances where initial medical supervision and/or instruction is required prior to patient self-administration.

The self-administered designation does not apply to prescription drugs that are: (a) mandated to be covered by law under the medical benefit (e.g., insulin or any drug required for the treatment of diabetes); or (b) required for treatment of an emergency condition that requires the use of a Company-determined self-administered drug (e.g., epinephrine).

When the member or caregiver is unable to administer a self-administered drug, the drug can be administered by an eligible professional provider (e.g., a professional provider may administer the drug when a caregiver is unable to provide treatment due to a prolonged trip or absence). In this situation, the drug remains ineligible for coverage under the medical benefit; however, the administration fee for the professional provider is covered and eligible for reimbursement under the member's medical benefit.

Injection therapy services (represented by "S" codes listed in the coding table of this policy) must not be utilized by the eligible professional provider when reporting the administration of a self-administered drug because these services encompass more than the administration of the drug (e.g., pharmacy services, care coordination). Therefore, they are not covered and not eligible for reimbursement under the medical benefit of the Company. Coverage may be available under the pharmacy benefit or through a pharmacy vendor. For members enrolled in commercial plans in NJ, self-administered coagulation factors may be available under the applicable medical or pharmacy benefit. Individual benefits must be verified.

MAINTENANCE OF DRUG LIST

The drugs listed in Attachment A of this policy are considered by the Company to be self-administered and are subject to change as new medications come to market or new determinations are made by the Company.
Guidelines

BENEFIT APPLICATION

Self-administered drugs listed in Attachment A of this policy may be covered under the member's pharmacy benefit, if one exists. Therefore, individual benefits must be verified, as coverage may vary by product and/or group. Providers should work directly with the member's Pharmacy Benefit Administrator on options to obtain a self-administered drug through specialty pharmacy distribution under the member's pharmacy benefit.

MEMBERS ENROLLED IN NEW JERSEY PLANS

For members enrolled in NJ Plans, self-administered coagulation factors may be available under the applicable medical or pharmacy benefit. Individual benefits must be verified.

Description

The Company defines a self-administered prescription drug ("self-administered drug") as a drug that can be administered safely and effectively by the patient or caregiver without medical supervision, regardless of whether initial medical supervision and/or instruction is required.

PROCESS FOR DETERMINING SELF-ADMINISTERED DRUGS

The Company reviewed each drug listed in Attachment A to arrive at a determination of which drugs should be classified as self-administered. The review involved evaluation of each drug's route of administration (ROA), its use in the treatment of an acute or chronic condition, and the frequency of administration that will be required.

The ROA is defined as the path by which a drug enters the body. Some common examples of ROA are as follows:
  • Intramuscular (IM) drugs are injected directly into a muscle. Many vaccines and antibiotics are delivered through this ROA.
  • Subcutaneous (SC) drugs are injected under the skin. Insulin is commonly delivered through this ROA.

In general, drugs administered through the SC ROA are drugs that can be injected safely and effectively by the patient or caregiver without medical supervision and are considered by the Company to be self-administered drugs. Professional providers teach the patient or caregiver how to safely administer these products. There are other circumstances where drugs for less commonly used indications are considered by the Company to be self-administered (i.e., IM injections for infertility) once the individual has been adequately trained.

The acuteness or chronicity of a condition and the frequency of drug administration typically required for treatment were also assessed to determine if a drug is considered self-administered. Drugs that are administered for a chronic condition (treatments generally lasting longer than two weeks) and/or are frequently administered (given one or more times per week) are generally considered self-administered. Conversely, drugs that are administered for an acute condition (treatments generally lasting less than two weeks) and/or are infrequently administered (less than once a week) are generally not considered self-administered.

In addition, there are drugs that can be used for more than one indication. The relative contribution for each indication to the total use of that drug (i.e., weighted average) was used to determine the overall designation of the ability to be self-administered. For example, a drug has three indications: the first indication comprises 95 percent of its use and is usually self-administered for this indication, and the second and third indications comprise 5 percent of its use and are usually not self-administered for these indications; thus the overall determination is that the drug is self-administered. Conversely, if the first indication comprises 5 percent of its use and the drug is usually self-administered, and the second and third indications comprise 95 percent of its use and the drug is not usually self-administered for these indications, the overall determination is that the drug is not self-administered.
References


Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 15: Covered Medical and Other Health Services. Section 50.2 [CMS Website]. (Effective 07-02-12). Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS012673.html. Accessed August 31, 2018.

Company Benefit Contracts.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD-10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD-10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)



REFER TO ATTACHMENT A FOR A LIST OF SELF-ADMINISTERED DRUGS.

THE INJECTION THERAPY SERVICES REPRESENTED BY THE FOLLOWING CODES ARE NOT COVERED WHEN USED TO BILL A SELF-ADMINISTERED DRUG:

S9370 Home therapy, intermittent antiemetic injection therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

S9372 Home therapy; intermittent anticoagulant injection therapy (e.g., Heparin); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem (do not use this code for flushing of infusion devices with Heparin to maintain patency)

S9537 Home therapy; hematopoietic hormone injection therapy (e.g., erythropoietin, G-CSF, GM-CSF); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

S9542 Home injectable therapy, not otherwise classified, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

S9558 Home injectable therapy; growth hormone, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

S9559 Home injectable therapy, interferon, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

S9560 Home injectable therapy; hormonal therapy (e.g., leuprolide, goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem



Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Self-Administered Drugs
Description: Prescription drugs that are considered by the Company to be self-administered.



Policy History

Revisions to 08.00.78aa
01/01/2019This version of the policy will become effective 01/01/2019.

The following drug has been removed from this policy:
  • daclizumab (high-yield process) (Zinbryta) - withdrawn from the market (HCPCS J3590)

This policy has been updated in consideration of the following new products:
  • (Ajovy) fremanezumab-vfrm - Monoclonal Antibodies - HCPCS J3590
  • (Arcalyst) rilonacept - Immunomodulators - HCPCS J2793
  • (Jivi) antihemophilic Factor VIII - Clotting Factor - HCPCS J7207
  • (Takhzyro) lanadelumab-flyo - Monoclonal Antibodies - treatment of HAE - HCPCS J3590
  • canakinumab (for subcutaneous use) - Monoclonal Antibodies - reduce the risk of recurrent cardiovascular (CV) events - HCPCS J3590
  • (Tegsedi) inotersen - Neuropathic Pain, Other - hereditary ATTR amyloidosis (hATTR) - HCPCS J3490
  • volanesorsen sodium - Antihyperlipidemia Agents - HCPCS J3490

The following drugs were already listed in this policy, but their name has been revised:
  • FROM: galcanezumab - HCPCS J3590
  • TO: galcanezumab-gnlm (Emgality) - HCPCS J3590
  • FROM: Fibryna
  • TO: Fibryga

The following coding changes were made:
  • Fibryga HCPCS coding change - FROM: J7178 TO: J7177
  • Rebinyn HCPCS coding change - FROM: J7195 TO: J7203
  • Hemlibra HCPCS coding change - FROM: Q9995 TO: J7170
  • Haegarda HCPCS coding change - FROM: J3590 TO: J0599

Revisions to 08.00.78z
07/01/2018This policy has been identified for the HCPCS code update, effective 04/01/2018.

The following HCPCS code has been added and the corresponding non-specific code removed from this policy:
ADDED: Q9995 Injection, emicizumab-kxwh, 0.5 mg
REMOVED: J7199 Hemophilia clotting factor, not otherwise classified

Revisions to 08.00.78y
05/28/2018This version of the policy will become effective 05/28/2018.

This policy has been updated in consideration of the following new products:
  • (Cyltezo) adalimumab-adbm - Antiarthritic, Syst. Bio. Response Modifier - HCPCS J3590
  • (Xyosted) testosterone enanthate - Sex Hormones, Other - HCPCS J3121
  • (Hemlibra) emicizumab-kxwh - Clotting Factor; Monoclonal Antibodies - HCPCS J7199
  • eptacog beta, activated - recombinant activated human Coagulation Factor VIIa - Clotting Factor - HCPCS J7189
  • erenumab-aooe (Aimovig) - Monoclonal Antibodies - HCPCS J3590
  • galcanezumab - Monoclonal Antibodies - HCPCS J3590
  • pegvaliase-pqpz (Palynziq) - Enzymes, Systemic - HCPCS J3590


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2019
Version Issued Date: 12/31/2018
Version Reissued Date: N/A

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