| Highmark Commercial Medical Policy - Pennsylvania |
| Medical Policy: | I-6-011 |
| Topic: | Approved Drugs and Biologicals |
| Section: | Injections |
| Effective Date: | March 4, 2013 |
| Issue Date: | June 25, 2018 |
| Last Reviewed: | May 2018 |
A drug is a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body. A biological is a therapeutic substance, such as a drug or vaccine, derived from biological sources. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Payment can be made for FDA - approved drugs and biologicals when used for indications other than those specified on the labeling, as long as:
NOTE: The method of administration is covered only when the drug is eligible.
When a physician gives an individual oral medication, these drugs are excluded from coverage since the form of the drug is self-administered. Similarly, if a physician gives an individual an injection that is recommended as self-injected, this drug is excluded from coverage, unless administered to the individual in an emergency situation.
NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
A network provider cannot bill the member for the non-covered service.
| Links |
12/2012, Physician dispensing pills or self-administered injections
PRN
08/1997, Drugs and biologicals pricing to change