Prior authorization required for listed infusion drugs

Prior authorization is required for the use of the medications listed in the policy tables when administered at an unapproved hospital-based outpatient infusion site and an approved site of care is available.

Prior authorization required for listed HCPCS infusion drugs

Prior authorization is required for the HCPCS-coded infusion products listed in the policy; site-of-care determinations and any authorization requests for these HCPCS-coded drugs must follow this site-of-care policy.

Site-of-care step requirements and initial allowances

When an approved alternative site of care is available, members should be transferred to that approved site; the policy waives site-of-care criteria for the first dose for all drugs and permits a limited number of additional initial doses at a non-approved site as specified per drug.

• First dose site-of-care criteria waived for all drugs to allow time to arrange an approved site of care (chunk 7).
• Select drugs permit additional limited doses at a non-approved site per the drug table; number of doses is drug-specific (chunk 7).

New start dose exceptions — follow HCPCS-specific allowances

Follow the drug-specific 'New Start Dose Exceptions' listed in the drug tables for agents that permit additional initial doses at a non-approved site; allowed values vary by HCPCS (examples include 1; 2 doses within 60 days; 4 doses within 60 days; 6 doses within 90 days).

• Examples of allowances include: 1 dose; 2 doses within 60 days; 4 doses within 60 days; 6 doses within 90 days (chunks 18, 28).
• Additional dose exceptions apply only to new start patients or patients reinitiating after discontinuation (chunk 14).

Required documentation for prior authorization and reauthorization

Obtain prior authorization when required; reauthorization every 6 months must include clinical and administration notes from the past six months demonstrating continued medical necessity and consideration of any newly available approved sites for transfer.

• Prior authorization must be obtained when necessary; approval of an unapproved site is separate from clinical prior authorization (chunk 6).
• Reauthorization occurs every 6 months and requires documentation from the prior six months and review of available approved sites (chunk 10).

Supply HCPCS, trade name, drug name, and dosing exception data

Include HCPCS code(s), trade name, drug name, and the applicable 'New Start Dose Exceptions' for each listed HCPCS code when submitting the authorization request.

• The drug tables map HCPCS → Trade Name → Drug Name → New Start Dose Exceptions and this information must be provided with the request (chunk 28).

Denial risk when an approved site is available

Requests for infusion at an unapproved hospital-based infusion center may be denied when an approved site of care is available and the unapproved setting is determined to be no longer medically necessary because it increases the cost of care.

• Use of an unapproved hospital-based infusion center is considered not medically necessary when it increases cost compared to approved sites (chunk 5).
• All exceptions to the site-of-care determination will be reviewed on a case-by-case basis; lack of documented exception rationale may lead to denial (chunk 30).

Exceptions reviewed case-by-case — provide documented clinical rationale

Exceptions to site-of-care determinations (allowing use of an unapproved hospital-based infusion center) will be reviewed on a case-by-case basis and require documented clinical rationale consistent with the policy’s listed criteria.

• Clinical criteria that may justify an exception include recent severe adverse drug reaction/anaphylaxis, complex conditions increasing infusion risk, need for concurrent higher-level infusion services, chronic vascular access complications, or mental health/cognitive issues (chunk 6).
• Home infusion infeasibility (home outside provider area or deemed unsafe/unfit) is also an exception (chunk 6).
• All exceptions are reviewed case-by-case (chunk 30).

Site-of-care settings — hospital outpatient may be denied if alternatives exist

Certain infused medications require administration at an approved site of care when an approved alternative is available; unapproved hospital-based infusion centers may be denied if an approved alternative exists.

• Approved sites include alternative sites of care or approved hospital-based infusion centers.
• Unapproved hospital-based infusion centers are considered medically unnecessary if they increase cost compared to approved sites.

Home or alternate-site infusion supported when clinically appropriate

Home or alternate-site infusion is supported when clinically appropriate and administered by trained staff following standardized protocols; home infusion may be used to reduce cost and support patient preference when feasible.

• Home infusion offers cost-effectiveness and comparable clinical outcomes when provided by trained nurses with monitoring protocols.
• Ensure the home is eligible and safe for home infusion per home infusion provider assessment.