MEDICAL ASSISTANCE HANDBOOK
PHYSICIANS’ SERVICES
PROCEDURES TO REQUEST PRIOR AUTHORIZATION ON CONTROLLED RELEASE
OXYCODONE/OXYCONTIN®
CONTENTS
I.
PAGE
Procedures to Request Prior Authorization for Controlled Release
Oxycodone/OxyContin®
A.
B.
C.
D.
E.
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Effective Date of Prior Authorization
Thresholds for Prior Authorization
Emergency Supplies
Early Fills
Initiating the Prior Authorization Request
1.
Who May Initiate the Request
2.
Where and When to Call
3.
Information to Be Available for the Prior Authorization Review
and Documented Within the Medical Record
F. Review Process
1.
Use of Medical Necessity Review Criteria
2.
Timeliness of the Review
3.
Approval/Prior Authorization Number
4.
Long Term Therapy
5.
Peer Review
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II.
Dispensing Considerations
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III.
Clinical Criteria for the Medical Necessity Review of Controlled Release
Oxycodone/OxyContin®
A. Brand Name
B. Generic Name
C. Oral Tablet Strengths/Generic Codes
D. FDA Indication
E. Criteria Elements
F. Expert Panel review and Approval
G. Literature References
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MEDICAL ASSISTANCE HANDBOOK I.
PHYSICIANS’ SERVICES
Procedures to Request Prior Authorization of Prescriptions for Controlled
Release Oxycodone/Oxycontin®
The procedures outlined within this section of the Physicians’ Services Handbook
relate to the requirements for prior authorization of certain prescriptions for
OxyContin® under the Medical Assistance (MA) Program, fee-for-service
component. Many of the HealthChoices managed care organizations (MCOs) also
have requirements for prior authorization of OxyContin®. Prescribers are referred to
the procedures defined by the applicable MCO for managed care prior authorization
requests.
A. Implementation Date for Prior Authorization
OxyContin® prescriptions meeting the thresholds outlined below, dispensed on
and after January 7, 2002, will require prior authorization.
B. Thresholds for Prior Authorization
The Department will require prior authorization for prescriptions for OxyContin®
that meet either or both of two (2) conditions:
1) Prescriptions that exceed doses of greater than three (3) tablets per day of
any single strength of OxyContin®.
The number of tablets per day is determined by the prescriber within the
prescribed directions for use. Directions for use are required on all Medical
Assistance prescriptions (see Physicians’ Services MA Handbook, Section I,
General Information, page I-9). However, upon dispensing the medication,
the pharmacist plays a key role in transmitting accurate information to the
Department. The pharmacist enters the “days’ supply” which in turn drives
the automated system alerts for prior authorization. The tablets per day value
is system calculated by dividing the quantity dispensed by the days supply.
Pharmacists need to appreciate the need for entering accurate information
within the days’ supply field as this element is key to an accurate alert for prior
authorization for OxyContin®. A shortening of the days’ supply to avoid a
later early refill alert can inaccurately increase the calculated tablets per day
and trigger a prior authorization that may not be necessary.
2) Prescriptions for more than two (2) different strengths of OxyContin® that are
taken concurrently.
Regardless of whether the third, or any subsequent, strength is actually
being taken concurrently, the Electronic Claims Management (ECM) pointof-sale on-line claims adjudication system may recognize the medication as
taken concurrently depending on the amount of time elapsing between
prescriptions. Accordingly, where the prescriber is aware that a third, or
additional, strengths are prescribed within the same timeframe that the
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earlier strengths would have covered, the prescriber should request a prior
authorization.
Note: It is possible for a physician to prescribe up to six (6) tablets per
day of OxyContin®, i.e., three (3) tablets for each of up to two (2)
strengths without prior authorization.
C. Emergency Supplies
The Department does not consider a delay in the receipt of OxyContin® to
present a life threatening emergency and, therefore, will NOT cover emergency
supplies of OxyContin® pending approval of a request for prior authorization.
Temporary alternative methods of pain relief may be necessary.
D. Early Fills
Additionally, early fills, i.e., dispensing an OxyContin® prescription when more
than 25% of an earlier dispensed supply remains, will not be approved and prior
authorization will not be granted for any exceptions.
E. Initiating the Prior Authorization Request
1.
Who May Initiate the Request
The prescriber must request the prior authorization.
2. Where and When to Call
Prior authorization requests will be accepted by the MA Fee-for-Service
Program Prior Authorization Unit at 1-800-558-2660 between the hours of
8:00 AM and 4:00 PM, Monday through Friday.
3. Information To Be Available for the Prior Authorization Review and
Documented Within the Medical Record
The information required at the time of a prior authorization review
includes the name and ACCESS card number of the recipient, the
prescriber’s license number and what is being prescribed, i.e.,: drug,
strength, quantity, directions/days’ supply. Additionally, clinical
information to apply the medical necessity criteria for OxyContin® will be
necessary. (The criteria are provided in Section III. of these procedures.)
Using criterion element number one (1) as an example, a description of
the etiology, severity, nature/type of pain and any effect on the
performance of the activities of daily living (ADL) will need to be
provided.)
The clinical information, provided during the course of the review, must
also be verifiable within the patient’s medical record. Upon retrospective
review, the Department may seek restitution for the cost of the
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prescription and any applicable restitution penalties from the prescriber, if
the medical record does not support the medical necessity for the
prescription. (Reference 55 Pa. Code § 1101.83 (b)).
F. Review Process
1.
Use of Medical Necessity Review Criteria
Department nurse reviewers will accept the prior authorization request
and apply review criteria to assess the medical necessity of the drug and
the dosage level. These criteria are included in section III on page A-26.
2.
Timeliness of Review
The Department will respond to prior authorization review requests within
twenty-four (24) hours.
3.
Approval/Prior Authorization Number
If the Department approves the request, a ten (10)-digit prior
authorization number will be issued. This number should be documented
on the prescription and within the medical record in the event that the
prescriber needs to reference the number for the patient/pharmacy.
4.
Long Term Therapy
The Department will consider requests to authorize multiple prescriptions
for a recipient during the prior authorization review when, in the
professional judgment of the reviewer, the condition producing the pain
reasonably can be expected to continue for longer than thirty (30) days.
The reviewer will approve multiple prescriptions consistent with the
expected duration of the pain/therapy, but not to exceed six (6)
prescriptions or six (6) months. When multiple prescriptions are
approved during a review, both the prescriber and the recipient will
receive written confirmation of the prior authorization numbers and
related prescription information.
Note: Authorization for multiple months does not waive the
requirement for original prescriptions for each month approved.
5.
Peer Review
If the criteria are not met, the prior authorization request will be referred
to the physician review level for a determination.
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MEDICAL ASSISTANCE HANDBOOK II.
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D
ispensing Considerations
The prescriber should also be aware that the MA ECM point-of-sale on-line claims
pharmacy system is being modified to assist in the monitoring of the requirements for
controlled release oxycodone/OxyContin®. The on-line system may detect a need
for prior authorization not previously known to the prescriber. For example, if a
consumer is receiving prescriptions from multiple prescribers unknown to each other
and the system detects multiple strengths or an excessive tablet supply, prior
authorization will be required. The pharmacist should contact the prescriber to alert
the prescriber that the prescription has tripped the threshold level and prior
authorization is now required. The prescriber should not ask the pharmacist to
call for the prior authorization number. Prior authorization numbers will be
provided only to the prescribing physician.
III.
Clinical Criteria for the Medical Necessity Review of Controlled Release
Oxycodone/OxyContin®
A. Brand Name
OxyContin®
B. Generic Name
Controlled Release Oxycodone
C. Oral Tablet Strengths/Generic Codes
10mg/16282 20mg/16283 40mg/16284 80mg/16286 160mg/92459 (not currently available from manufacturer)
D. FDA Indication
The controlled release oral form of oxycodone/OxyContin® is indicated for the
management of moderate to severe pain when a continuous, around-the-clock
opioid analgesic is needed for an extended period of time. OxyContin® is not
intended for use as a PRN (“as needed”) analgesic or for acute, short-term pain
relief.
E. Criteria Elements
All three (3) of the following medical necessity criteria elements must be met in
the professional judgment of the reviewer, for verification of medical necessity
and approval of prior authorization at a non-physician review level. Situations not
meeting one or more of the following criteria will be considered on a case-by
case basis by a physician reviewer to determine the medical necessity.
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1. There is a documented history of pain that includes all of the following:
•
•
•
•
Pain arises from a chronic condition; AND
Pain is moderate to severe in nature; AND
Pain is sustained and persistent rather than brief and intermittent; AND
Pain interferes with the activities of daily living (ADL) such as work,
mobility, sleep, eating, personal hygiene and social functioning.
2. A narcotic pain reliever is the most appropriate treatment option as documented by one or more of the following elements:
• Pain is inadequately controlled by non-narcotic pain relievers, including
non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (APAP),
and aspirin (ASA); OR
• Recipient exhibits contraindications to non-narcotic pain relievers, such
as allergy, drug-disease interaction, drug-drug interaction, history of
adverse reaction; OR
• There is documentation regarding an earlier episode of the same pain
etiology and nature where management with non-narcotic medication
was inadequate; OR
• The pain is so severe that it would be appropriate to initiate pain
management with opioids such as pain resulting from metastatic disease
or severe orthopedic trauma.
3. The proposed dosage is the minimum effective dosage. For doses and
dosing intervals that exceed the FDA-approved starting dose of 10 mg. every
twelve (12) hours, there is documentation demonstrating an appropriate
upward titration of Oxycontin® or an appropriate conversion from other opioidcontaining medications.
F. Expert Panel Review and Approval
These criteria have been reviewed and approved by an independent panel of
experts including multiple physician specialties, pharmacists and a consumer
representative. The physician specialties represented included anesthesiology,
addiction medicine, hematology, oncology, pain management and family
practice. Additionally, the panel included pharmacists from the University of
Maryland, School of Pharmacy’s Center on Drugs and Public Policy and staff
from the Pennsylvania Medical Society’s Center for Professional Drug Education.
G. Literature References
References included, but were not limited to:
Jacox A, Carr DB, Payne E, et al. Management of cancer pain. Clinical practice
guideline no. 9, AHCPR Publication No. 94-0592. Agency for Health Care Policy
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and Research, U.S. Department of Health and Human Services, Public Health
Service. Rockville, MD. 1994.
Model guidelines for the use of controlled substances for the treatment of pain.
Federation of State Medical Boards of the United States, Inc. May 2, 1998.
Purdue Pharma LP. Product Information: OxyContin®; July 2001.
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