1/31/2005
Aetna’s Clinical Policy Process
and Medicare Coverage Decisions
James D. Cross, M.D.
February 2, 2005
Overview
We will discuss the following issues:
• The purposes and goals of clinical policy at
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Aetna
The criteria Aetna uses to evaluate medical
technologies and treatments
Aetna’s clinical policy development process
The relationship between Aetna clinical policy
and Medicare policy
Implementation of Aetna’s clinical policies
Examples – CMS and Aetna policies
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Draft; Confidential
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Clinical Policy Development –
Goals and Criteria
Goals:
• The goal is to develop objective, clinically supported
and defensible determinations.
• Must evaluate whether technology is “experimental
and investigational” and “medically necessary” as
defined in applicable coverage documents
Criteria:
• Technology has final approval
• Evidence permits conclusions regarding outcomes
• Must improve net health outcomes
• Must be as beneficial as any established alternative
• Improvement is attainable outside of investigation
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CMS - Basic Definition of Coverage
For any item to be covered by Medicare, it must:
• Be eligible for a defined Medicare benefit
• Be reasonable and necessary for the diagnosis and
treatment of illness or injury or to improve the
functioning of a malformed body member, and
• Meet all other applicable Medicare statutory and
regulatory requirements.
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Draft; Confidential
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Rating Quality of Evidence
• Aetna evaluates the safety and effectiveness of medical
technologies based on the quality of evidence.
• Several evidence rating scales have been developed.
• The US Preventive Services Task Force grades the quality
of the overall evidence on a 3-point scale:
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Good: Evidence includes consistent results from welldesigned, well-conducted studies in representative
populations that directly assess effects on health outcomes
Fair: Evidence is sufficient to determine effects on health
outcomes; strength of evidence is limited by number, quality
or consistency of the study
Poor: Evidence is insufficient to assess the effects on
health outcomes because of limited number, flaws in design,
gaps in chain of evidence or lack of information on
outcomes
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Clinical Policy Bulletins – Prioritizing
and Drafting
Factors are considered in prioritizing CPB requests:
• Quantity and importance of questions regarding
technology
• New evidence, guidelines, consensus statements,
changes in regulatory status or other information that
is material to the status of the medical technology
• The potential impact of the technology
Drafting CPB’s:
• Comprehensive search of peer-reviewed published
medical literature:
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MEDLINE database
Regulatory status of technology
Technology assessments as well as positions or
guidelines of specialty societies and/or expert opinions
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Draft; Confidential
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Final Approval and Annual Review of
CPB’s
Final Approval requires review and approval by:
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Aetna’s Clinical Policy Council
Head of Aetna’s Medical Policy Admin. Dept.
Aetna’s Legal Department
Aetna’s Chief Medical Officer or his designee
Annual Review
• Each policy is reviewed against peer-reviewed
published medical literature to determine if new
information warrants a revision in policy
• All CPB’s are reviewed annually by Aetna’s Clinical
Policy Council
All CPB’s are publicly disclosed on Aetna’s public
website – similar to CMS national policies
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Role of Medicare Policy
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For Aetna commercial members, Aetna is not
obligated to follow Medicare clinical policy.
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Medicare’s clinical policy is considered in
formulating Aetna’s clinical policies for its
commercial plans.
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For Medicare risk members, Aetna is required to
follow either Aetna’s clinical policy or Medicare’s
clinical policy – whichever is most liberal
(includes both national and local CMS policies).
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Aetna is obligated to follow Medicare
reimbursement policy when services are rendered
by non-participating providers.
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Draft; Confidential
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Aetna Standard Table (AST)
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Systematically supports the application of standard
coverage and reimbursement policies across all
products and processing systems
Effective date of policy change is based on date of
service (same as CMS).
Automatically allows for the pending of line items
that require medical necessity review across all
products and systems
Pre-authorized services are considered eligible no
matter what the determination is within the AST
Can accommodate exceptions by Client, Benefit Plan
and State – this allows administration of Medicare
exceptions
Removes processor from ‘decision-making’ role in
terms of interpreting clinical policy
Clinical staff (and participating providers) can easily
identify applicable CPB’s associated with specific
codes as the CPB #s are displayed on the AST
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Examples – Aetna and CMS
Aetna and CMS coverage position is the same:
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External Insulin Infusion Pumps for Diabetes (CPB
# 161)
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PET scans (except PET for Alzheimer’s disease)
(CPB # 71)
Aetna established coverage first, CMS followed:
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Immunohistochemical Fecal Occult Blood Testing
for Colorectal Cancer (CPB # 516)
– Covered by Aetna beginning Feb 2003
– Covered by CMS beginning January 2004
CMS established coverage first, Aetna followed:
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Drug Eluting Stents (CPB # 621)
– FDA approval beginning April 2003
– Covered by CMS beginning April 2003
– Covered by Aetna beginning June 2003
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Draft; Confidential
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Examples – Aetna and CMS
Aetna and CMS coverage position differs:
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High-frequency Pulsed Electromagnetic Stimulation
(Diapulse and SofPulse) (CPB # 175)
– Aetna considers this technology experimental
because effectiveness has not been established
Digital Mammography (CPB # 486)
– Clinical superiority of this technology has not
been demonstrated
Aetna and Local Carrier position may differ:
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Intensity Modulated Radiation Therapy (CPB#590)
– No national CMS policy on this technology
– Aetna covers IMRT for brain, head, neck, spine,
paraspinal region and prostate (not lung or
breast)
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Examples – Aetna and CMS
Aetna and CMS coverage position differs:
Total Artificial Heart (Heart Transplantation (CPB #586)
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Aetna considers an FDA-approved total artificial heart
medically necessary when used as a bridge to
transplant for transplant-eligible members who are at
imminent risk of death
Medicare does not cover the use of artificial hearts…as
a temporary life-support system until a human heart
becomes available for transplant (often referred to as a
“bridge to transplant”). (NCD for Heart Transplants
(260.9))
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Draft; Confidential
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Examples – Aetna and CMS
Aetna and CMS coverage position differs:
Obesity Surgery (CPB #157)
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Aetna considers obesity surgery medically necessary
for members who meet specific selection criteria
Medicare states: “The safety of intestinal bypass
surgery for treatment of obesity has not been
demonstrated…It does not meet the reasonable and
necessary provisions of…the Act and is not a covered
Medicare procedure. (NCD for Treatment for Obesity
(40.5))
Please note: Some Aetna plans may entirely exclude
coverage of surgical treatment of obesity.
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Contact Information
James D. Cross, MD
Head of Medical Policy Administration
Aetna
crossjd@aetna.com
301
- 636
- 119
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Draft; Confidential
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