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Medication
Policy Manual
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Policy
No:
dru150
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Topic: Medication Policy
Manual Introduction
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Date
of Origin:
September 7, 2007
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Committee
Approval Date: March 2, 2012
Effective Date:
March 16, 2012
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Next
Review Date:
March 2013
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Medication Policy Development and Review Process
Purpose of the Manual
The purpose of RegenceRx
medication policy is to provide criteria and guidelines for determining
coverage of specific medications.
In order to be eligible for coverage, all medications must be
medically necessary (unless otherwise provided in the member's benefits
contract). To the extent there are any conflicts between RegenceRx
medication policy guidelines and applicable contract language, the
contract language prevails. RegenceRx medication policy is not intended
to override the health insurance policy that defines the insured’s
benefits, nor is it intended to dictate to providers how to practice
medicine. Physicians and other health care providers are expected to
exercise their medical judgment in providing the most appropriate care.
The policies are not intended to constitute medical advice and do not
guarantee any results or outcomes. They are meant to be consistent
statements of medical necessity criteria for coverage through available
benefits.
Policy Development
Issues are selected for
medication policy development through referrals from RegenceRx staff,
the physician and provider community, and members. Priority may be
given to the following:
·
New medications for which there are
scientifically-proven, safe, effective alternatives.
·
Medications that have generated a high level
of interest for members and/or providers.
·
Medications that may be prescribed for
conditions that are not a covered benefit.
·
Medications that are
controversial with respect to their ability to improve net health
outcome.
·
New information available in the
peer-reviewed scientific literature that may change the status of an
indication for a medication from investigational to medically
necessary.
The following sources are
considered in the development and revision of Regence medication
policies:
·
Current published medical literature
from peer-reviewed publications.
·
Evidence-based clinical practice guidelines
developed by national organizations and recognized authorities.
·
Generally accepted standards of medical
practice.
·
External practicing physician review.
·
Government approval status.
·
National medication compendia,
including, but not limited to AHFS
(American Hospital Formulary Service) Drug Information, Thomson Micromedex
DrugDex, National
Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium, and
U.S. Pharmacopeia Drug
Information.
·
Policies and technology assessments
published by the BlueCross BlueShield Association and the BlueCross
BlueShield Association Technology Evaluation Center (TEC).
Definition of Medical Necessity
Medically necessary or medical
necessity means health care services that a physician, exercising
prudent clinical judgment, would provide to a patient for the purpose
of preventing, evaluating, diagnosing or treating illness, injury,
disease or its symptoms, and that are:
(a) in accordance
with generally accepted standards of medical practice;
(b) clinically
appropriate in terms of type, frequency, extent, site and duration, and
considered effective for the patient’s illness, injury or disease; and
(c) not primarily for
the convenience of the patient, physician, or other health care
provider, and not more costly than an alternative service or sequence
of services at least as likely to produce equivalent therapeutic or
diagnostic results as to the diagnosis or treatment of that patient’s
illness, injury or disease.
Generally Accepted Standards of Medical Practice
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, physician specialty
society recommendations and the views of physicians practicing in
relevant clinical areas and any other relevant factors.
Definition of Investigational Services
In this manual, the term
"investigational" means that the medical technology does not
meet Regence's technology assessment criteria, as defined below. If any
one or more of the criteria are not met, the technology will be
determined to be investigational. In addition, all services
specifically associated with the investigational technology, including,
but not limited to, associated procedures, treatments, supplies,
devices, equipment, facilities or drugs, will also be considered
investigational.
Technology Assessment Process
The technology assessment
process is applied to both the development of new medication policies
and the updating of existing policies. In order to determine whether a
medication may be considered medically necessary, literature searches
are conducted and the published scientific evidence related to each
medication is reviewed against five technology assessment criteria. In
order for a medication to be considered medically necessary for an
indication, all five criteria must be met. As noted above, if any one
or more of the following criteria are not met, then the medication is
considered investigational:
1.
The medication must have final marketing
approval from the appropriate government regulatory body, specifically,
the Food and Drug Administration (FDA). Final marketing approval is
evidenced by an approved NDA, ANDA, or BLA (New Drug Application,
Abbreviated New Drug Application, or Biologic License Application). A
medication’s NDA, ANDA, or BLA may be located at: www.accessdata.fda.gov/scripts/cder/drugsatfda/ Any
approval that is granted as an interim step (i.e., Treatment IND) in
the FDA regulatory process is not sufficient.
The
scientific evidence must permit conclusions concerning the effect of
the medication on health outcomes. The evidence should consist of
well-designed and well-conducted investigations published in
peer-reviewed journals. The quality of the body of studies and the
consistency of the results are considered in evaluating the evidence. Opinions
and evaluations by national medical associations, consensus panels,
clinical practice guidelines or other technology evaluation bodies are
evaluated according to the scientific quality of the supporting
evidence and rationale.
2.
The medication must improve the net health
outcome. Scientific evidence and expert opinion provide the basis for
summarizing the potential net health outcome. The evidence should
demonstrate that the medication can alter the physiological changes
related to a disease, injury, illness or condition. In addition, there
should be evidence or a convincing argument based on established
medical facts that such alteration affects the health outcomes.
3.
The medication should improve the net health
outcome as much as or more than established alternatives.
External Physician Review
All new and revised Regence
medication policies are sent for review in draft form to external
practicing physicians. Physicians who wish to participate in this
process may contact Regence Medical Policy at: www.regence.com/trg/contact/.
Approval Process
All policy drafts, including
analyses of the scientific evidence and summaries of the external
expert opinion, are presented to the Regence Medication Policy Group
(MPG) for final approval. MPG consists of professional medication
policy staff and physician medical directors from Idaho,
Oregon, Utah
and Washington.
Medication Policy Updates
Medication policies are
re-evaluated and updated regularly. Policies may be reviewed prior to
their scheduled annual review date if new scientific evidence that
would alter the policy criteria becomes available sooner.
Medication Policy Dissemination
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Medication policies are published
on-line and available to members, providers and the general public at http://blue.regence.com/policy/medication/contents.html.
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Significant policy changes are
communicated through provider newsletters and are noted on-line at http://blue.regence.com/trgmedpol/drugs/PolicyUpdates.pdf.
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