Pending Policies - Prescription Drugs


Specialty Medication Administration Site of Care

Number:RX501.096

Effective Date:11-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Medical policies are a set of written guidelines that support current standards of practice. They are based on current peer-reviewed scientific literature. A requested therapy must be proven effective for the relevant diagnosis or procedure. For drug therapy, the proposed dose, frequency and duration of therapy must be consistent with recommendations in at least one authoritative source. This medical policy is supported by FDA-approved labeling and nationally recognized authoritative references. These references include, but are not limited to: MCG care guidelines, DrugDex (IIb strength of recommendation or higher), NCCN Guidelines (IIb level of evidence or higher), NCCN Compendia (IIb level of evidence or higher), professional society guidelines, and CMS coverage policy.

NOTE 1: The medical necessity of the infused pharmacologic or biologic agent may be separately reviewed against the appropriate criteria. This document addresses only the determination of the medical necessity of hospital outpatient level of care for the intravenous infusion and injectable therapy.

NOTE 2: The first two doses or 30 days (whichever is less) of initiation of therapy may be given at the physician’s facility of choice. This includes hospital outpatient facilities, non-hospital outpatient facilities and home care. All subsequent doses will be subject to the criteria listed below which requires the use of non-hospital outpatient facilities or home infusion when clinically appropriate.

Infusions in a hospital outpatient facility setting may be considered medically necessary when there is clinical documentation the member is medically unstable for infusions at alternative levels of care, such as the provider office or home setting, as noted by any of the following:

Documented clinical history of cardiopulmonary conditions that may cause an increased risk of severe adverse reactions; OR

An inability to safely tolerate intravenous volume loads, including from unstable renal function; OR

Member is reinitiating therapy after not being on therapy for at least 6 months; OR

Member has a previously documented severe or potentially life-threatening adverse event during or following infusion of the prescribed drug, and the adverse event cannot be managed through pre-medication in the home or office setting; OR

Physical or cognitive impairments that impede safe administration and there is no home caregiver available or willing to assist with the infusion; OR

Difficulty establishing and maintaining patent vascular access; OR

The member’s home has been determined to be inappropriate for home infusion by a social worker, case manager, or previous home nurse assessment.

EXCEPTION: Children (under age 18 years) receiving specialty medication infusions for which home or office based infusions may not be safe or practical.

All other uses of outpatient infusions in the hospital outpatient department or hospital outpatient clinic level of care for the infusion of pharmacologic and biologic agents are considered not medically necessary.

Description:

Site of care refers to the choice for physical location for infusion administration of medications, and can include the following settings: inpatient hospital, outpatient hospital, provider office, ambulatory infusion suite or home.

New technologies and pharmaceuticals allow therapeutic services, such as infusion therapy, to be administered safely and effectively outside of hospital-based infusion centers. Sites of care such as physician offices, ambulatory infusion centers and home infusion services are well accepted places of service for medication infusion services.

Rationale:

Infusions of medications in the home setting are appropriate for medically stable patients who do not require close observation or daily nursing care. According to the 2017 MCG™ Care Guidelines for Home Infusion Therapy, the patient or caregiver should demonstrate the ability and willingness to participate in the therapy and perform the infusion procedure. (1)

A systematic review by Polinski et al., which included 13 relevant studies identified through MEDLINE, EMBASE and Science Citation index search, concluded that patients receiving home infusions were no more likely to experience adverse drug events or side effects (all p >0.05). Patients overwhelmingly preferred receiving infusion at home rather than in a health care facility. The review also showed that home infusion is well suited to medication delivery in clinical areas such as neurology, oncology, hematology, rheumatology and gastroenterology. (2)

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

None

HCPCS Codes

C9466, C9493, J0129, J0180, J0221, J0490, J0517. J0598, J0717, J1290, J1300, J1301, J1322, J1458, J1459, J1555, J1556, J1557, J1559, J1561, J1566, J1568, J1569, J1572, J1575, J1602, J1743, J1745, J1786, J1931, J2182, J2323, J2350, J2357, J2507, J2786, J2840, J3262, J3358, J3380, J3385, Q5103, Q5104

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at .

References:

1. MCG™ Care Guidelines, 21st edition, 2017, Home Infusion Therapy, CMT: CME-0009(SR).

2. Polinski JM, Kowal MK, Gagnon M, et al. Home infusion: safe clinically effective, patient preferred, and cost saving. Healthcare. 2016. Available at: <https://www.healthnewsreview.org> (accessed August 7, 2017).

3. Guidelines for the site of care for administration of IGIV therapy. Available at: (accessed August 7, 2017).

4. Eight Guiding Principles for Effective Use of IVIG for Patients with Primary Immunodeficiency. Available at: (accessed August 7, 2017).

Policy History:

Date Reason
11/15/2018 Reviewed. No changes.
4/1/2018 New medical document outlining appropriate site of care for administration of specialty medications.

Archived Document(s):

Title:Effective Date:End Date:
Specialty Medication Administration Site of Care04-01-201811-14-2018
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