Printer Friendly Version
Printer Friendly Version
L.5.01.573
Please perform a Formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this Medical Policy may not be covered under a specific member’s benefit plan.
New Drug Approval Process
A new drug, whether a new-to-market medication or newly approved brand, generic, biologic, or biosimilar, is approved by the FDA after documenting it is safe and effective for its proposed uses, contains appropriate labeling, and has safe manufacturing practices to preserve the drug’s identity, strength, quality, and purity. Before Blue Cross & Blue Shield of Mississippi (BCBSMS) can determine coverage guidelines for a new drug, there is an evaluation period that begins with market availability. During the evaluation period by the BCBSMS Pharmacy & Therapeutics (P&T) Committee and internal business review, these medications will be considered non-formulary and/or not medically necessary. Each new drug must be reviewed by BCBSMS P&T Committee to evaluate clinical benefits and risks. The P&T Committee will use clinical data as well as patient safety information to provide a coverage determination for each new drug reviewed.
Once the P&T Committee and internal business review has been completed and coverage guidelines are developed, Blue Cross & Blue Shield of Mississippi’s Formulary and Medical Policy will be updated.
New Indication for Currently Available Medication Process
When the FDA approves a new indication for a currently available medication, the new indication will be evaluated. Prior to coverage determination by the BCBSMS P&T Committee and internal business review, the new indication or new-to-market medication will be considered non-formulary and/or not medically necessary. If a Medical Policy exists for the medication, this Medical Policy has a purpose to hold the medication in not medically necessary/non-formulary status for the indication requested until the aforementioned review can occur. The P&T Committee will use clinical data as well as patient safety information to provide a coverage determination for each new indication reviewed.
Once the P&T Committee and internal business review has been completed and coverage guidelines are developed, Blue Cross & Blue Shield of Mississippi’s Formulary and Medical Policy will be updated.
New-to-market and newly FDA-approved brand, generic, biologic agent or biosimilar agent will be considered not medically necessary/non-formulary until the medication can be reviewed by both the BCBSMS P&T Committee as well as the internal business committee.
New indications which are approved by the FDA for medications which are already commercially available will be considered not medically necessary/non-formulary for the indication until the newly approved indication can be reviewed by both the BCBSMS P&T Committee as well as the internal business committee.
Services related to delivery and/or administration of a medication which is new-to-market, newly FDA-approved or has had a label expansion (new indication) will be considered not medically necessary until the medication can be reviewed by both the BCBSMS P&T Committee as well as the internal business committee.
State Health Plan (State and School Employees) Participants
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
appropriate with regard to standards of good medical practice; and
not solely for the convenience of the Member, his or her Provider; and
the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
09/11/2020: New policy added.
01/18/2023: Policy reviewed; no changes.
07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.
12/07/2023: Policy reviewed; no changes.
10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee.
09/09/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee.
None
This may not be a comprehensive list of procedure codes applicable to this policy.
Not Medically Necessary/Non-Formulary Codes
Code Number | Description |
CPT-4 | |
All drugs that are new-to-market, newly FDA-approved, or with new indications | |
HCPCS | |
All drugs that are new-to-market, newly FDA-approved, or with new indications | |
ICD-10 Procedure | |
ICD-10 Diagnosis |
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.