PARTNERSHIP HEALTHPLAN OF CALIFORNIA
POLICY / PROCEDURE
Policy/Procedure Number: HKRP4054 (previously KK RX302 &
Lead Department: Health Services
MPRP4054)
Policy/Procedure Title: Prescription Drugs for Non-approved uses –
External Policy
Commercial Lines of Business
Internal Policy
Next Review Date: 10/01/2005
Original Date: 11/16/2005
Last Review Date: 10/01/2010
Applies to:
Medi-Cal
Healthy Kids
Employees
Reviewing
Entities:
IQI
P&T
QUAC
OPERATIONS
EXECUTIVE
COMPLIANCE
DEPARTMENT
Approving
Entities:
BOARD
COMPLIANCE
FINANCE
PAC
CEO
COO
CREDENTIALING
Approval Signature: Ronald Chapman, MD, MPH
DEPT. DIRECTOR/OFFICER
Approval Date: 10/01/2010
I.
RELATED POLICIES:
A. ..
II.
IMPACTED DEPTS.:
A. ..
III.
DEFINITIONS:
A. ..
IV.
ATTACHMENTS:
A. N/A
V.
PURPOSE:
To define the conditions under which prescription drugs are covered for PHC members covered under
commercial lines of business.
VI.
POLICY / PROCEDURE:
PHC covers prescription drug benefits. PHC allows medications for the use that is different from the use for
which that drug has been approved for marketing by the federal Food and Drug Administration (FDA),
provided that conditions I. through III. have been met:
A. The drug is approved by the FDA.
B. The drug is prescribed by a participating licensed health care professional for the treatment of a lifethreatening condition; or the drug is prescribed by a participating licensed health care professional for
the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat
that condition, and the drug is on the plan formulary. If the drug is not on the plan formulary, the
participating subscriber's request shall be considered pursuant to the process described in the Pharmacy
TAR policy.
C. The drug has been recognized for treatment of that condition by one of the following:
1. The American Medical Association Drug Evaluations.
2. The American Hospital Formulary Service Drug Information.
3. The United States Pharmacopoeia Dispensing Information, Volume 1, "Drug Information for the
Health Care Professional."
4. Two articles from major peer reviewed medical journals that present data supporting the proposed
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Policy/Procedure Number: HKRP4054 (previously KK RX302
Lead Department: Health Services
& MPRP4054)
☒External Policy
Policy/Procedure Title: Prescription Drugs for Non-approved
uses – Commercial Lines of Business
☐Internal Policy
Next Review Date: 10/01/2005
Original Date: 11/16/2005
Last Review Date: 10/01/2010
Applies to: ☐ Medi-Cal
☒ Healthy Kids
☐ Employees
off-label use or uses as generally safe and effective unless there is clear and convincing
contradictory evidence presented in a major peer reviewed medical journal.
D. It shall be the responsibility of the participating prescriber to submit to the plan documentation
supporting compliance with the requirements if requested by the plan.
E. Any coverage required by this policy shall also include medically necessary services associated with the
administration of a drug, subject to the conditions of the contract.
F. For purposes of this policy, "life-threatening" means either or both of the following:
1. Diseases or conditions where the likelihood of death is high unless the course of the disease is
interrupted.
2. Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is
survival
G. For purposes of this policy, "chronic and seriously debilitating" means diseases or conditions that require
ongoing treatment to maintain remission or prevent deterioration and cause significant long-term
morbidity.
H. The provision of drugs and services when required by this policy shall not, in itself, give rise to liability
on the part of the plan.
I.
Nothing in this policy shall be construed to prohibit the use of a formulary, co-payment, technology
assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug
that is prescribed for a use that is different from the use for which that drug has been approved for
marketing by the FDA.
J.
If a plan denies coverage pursuant to this policy on the basis that its use is experimental or
investigational, that decision is subject to review.
VII.
REFERENCES:
A. N/A
VIII.
DISTRIBUTION:
A. Provider Manual
B. PHC Directors
IX.
POSITION RESPONSIBLE FOR IMPLEMENTING PROCEDURE:
REVISION DATES:
Healthy Kids
10/01/10
PREVIOUSLY APPLIED TO:
Healthy Families:
MPRP4054 – 10/01/2010 to 03/01/2013
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