Cancer Screening Tests and Clinical Trials

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PARTNERSHIP HEALTHPLAN OF CALIFORNIA
POLICY / PROCEDURE
Policy/Procedure Number: HKUP3068 (previously MPUP3068 &
KK UM102)
Lead Department: Health Services
External Policy
Internal Policy
Next Review Date: 10/01/2015
Last Review Date: 10/01/2010
Policy/Procedure Title: Cancer Screening Tests and Clinical Trials
Original Date: 11/16/2005
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
Approval Signature: Robert Moore, MD, MPH
CREDENTIALING
DEPT. DIRECTOR/OFFICER
Approval Date: 10/01/2010
I.
RELATED POLICIES:
A. …
II.
IMPACTED DEPTS:
A. …
III.
DEFINITIONS:
A. N/A
IV.
ATTACHMENTS:
A. N/A
V.
PURPOSE:
To define coverage for PHC Knox-Keene members needing cancer screening tests or participation in
cancer clinical trial.
VI.
POLICY / PROCEDURE:
A. All generally accepted cancer screening tests are covered when a member is referred by a contracted
health care provider.
B. The routine patient health care costs associated with a PHC Knox-Keene member’s participation in a
cancer clinical trial will be covered when the following criteria are met:
1. The member has a diagnosis of cancer
2. The member has been accepted into a Phase I, II, III or IV clinical trial for cancer.
3. The member’s treating physician, who is contracted by the health plan to provide health care
services, must recommend participation in the cancer clinical trial
C. To be eligible for coverage of routine patient care costs associated with participation in a cancer clinical
trial, the cancer clinical trial must meet the following requirements:
1. The cancer clinical trial endpoint must not be defined exclusively to test toxicity but must have a
therapeutic intent
2. The treatment provided in the cancer clinical trial must either be
a. Approved by one of the following:
1) NIH
2) FDA
Page 1 of 2
Policy/Procedure Number: HKUP3068 (previously
Lead Department: Health Services
MPUP3068 & KK UM102)
☒External Policy
Policy/Procedure Title: Cancer Screening Tests and Clinical
Trials
☐Internal Policy
Next Review Date: 10/01/2015
Original Date: 11/16/2005
Last Review Date: 10/01/2010
Applies to: ☐ Medi-Cal
☒ Healthy Kids
☐ Employees
3) US Department of Defense
4) US Department of Veterans’ Administration
OR
b. Involve a drug that is exempt under federal regulations from a new drug application
D. PHC shall pay for all routine patient care costs provided at contract rates. Those rendered by noncontracted providers shall be reimbursed at the negotiated rate the health plan would otherwise pay to a
contracted provider for the same service, less any applicable co-payments or deductible.
VII.
REFERENCES:
A. California Health and Safety Code, Section 1370.6 and 1367.66 et.seq.
B. California Senate Bill 37, Chaptered 2001
VIII.
DISTRIBUTION:
A. Provider Manual
B. PHC Directors
IX.
POSITION RESPONSIBLE FOR IMPLEMENTING PROCEDURE:
X.
REVISION DATES:
Healthy Kids
11/21/07; 11/19/08; 06/16/10; 10/01/10
PREVIOUSLY APPLIED TO:
Healthy Families:
MPUP3068 - 10/01/10 to 03/01/2013
*********************************
In accordance with the California Health and Safety Code, Section 1363.5, this policy was developed with
involvement from actively practicing health care providers and meets these provisions:



Consistent with sound clinical principles and processes
Evaluated and updated at least annually
If used as the basis of a decision to modify, delay or deny services in a specific case, the criteria will be
disclosed to the provider and/or enrollee upon request
The materials provided are guidelines used by PHC to authorize, modify or deny services for persons with similar
illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits
covered under PHC.
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