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PGxHealth Reimbursement Services
Introduction
- The reimbursement environment for the FAMILION tests for inherited cardiac syndromes
has improved significantly during the past three years.
- PGxHealth is devoting increasing resources to assist patients with reimbursement services.
PGxHealth Reimbursement Services
- PGxHealth will assist each patient by working with the insurance provider to pre-authorize
services and determine benefit information upon request.
- PGxHealth will contact the patient with this information prior to the initiation of testing.
- PGxHealth will be quoted an estimate of coverage from the insurance carrier and cannot
guarantee reimbursement.
- Following the completion of testing, PGxHealth will file the insurance claim with the
provider.
For additional information, please contact PGxHealth’s Customer Service team
at 877-2-PGxHealth (877-274-9432) or visit www.pgxhealth.com
Select Commercial Payers With Supportive Coverage Policies
- Aetna
- Harvard Pilgrim
- BCBS (AK, AL, AR, HI, ID, IL, MI, MS, NJ, NM, NY, OK, SD, TN, TX, WA)
- Cigna
- Coventry Health Care
- HIP Plan of NY
- Health Net, Inc.
- Humana
- Select Health
- Tufts Health
Select Government Payers With Supportive Coverage Policies
PGxHealth—An Approved Medicaid Provider
- PGxHealth has applied to be an approved Medicaid provider in all 50 states.
- The following states have approved PGxHealth’s application to be a Medicaid provider (as
of mid-May 2008):
- New York
- Illinois
- Pennsylvania
- North Carolina
- Arizona
- Washington
- Indiana
- Missouri
- Minnesota
- Wisconsin
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- Colorado
- Oregon
- Oklahoma
- Connecticut
- Iowa
- Kansas
- Utah
- West Virginia
- Idaho
- Maine
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- Montana
- Vermont
- Texas
- Ohio
- Alaska
- Louisiana
- Wyoming
- Mississippi
- New Mexico
- Georgia
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The FAMILION® Tests—Select Coverage Policies
Blue Cross Blue Shield Technical Evaluation Center (TEC)
http://www.bcbs.com/betterknowledge/tec/vols/22/22_09.html
Full report available at http://www.bcbs.com/betterknowledge/tec/vols/22/22_09.pdf
The TEC Committee concluded that:
- Genetic testing for long QT syndrome (LQTS) meets the Blue Cross Blue Shield TEC
criteria for establishing the diagnosis of LQTS in the following patient populations:
Individuals who do not meet the clinical criteria for LQTS but who have: A close relative
(first-, second-, or third-degree relative) with a known LQTS mutation; or
A close relative diagnosed with LQTS by clinical means whose genetic status is
unavailable; or
Signs and/or symptoms indicating a moderate to high pre-test probability of LQTS.
An individual who meets the clinical criteria for LQTS and has a close relative at risk for
LQTS is an indication for genetic testing. In this circumstance, testing of the individual
with LQTS is intended to inform genetic testing options for at-risk relatives.
- Genetic testing for LQTS does not meet the TEC criteria for determining prognosis and/
or directing therapy in patients with known LQTS who do not have close relative(s) with
indications for genetic testing.
Determining the pre-test probability of LQTS is not standardized. An example of a patient
with a moderate to high pre-test probability of LQTS is a patient with a Schwartz score of 2-3.
Aetna
http://www.aetna.com/cpb/medical/data/100_199/0140.html
Aetna considers genetic testing for LQTS medically necessary for EITHER of the following:
- Persons with a prolonged QT interval on resting electrocardiogram (a corrected QT interval
(QTc) of ≥470 msec in males and ≥480 msec in females) without an identifiable external
cause for QTc prolongation (such as heart failure, bradycardia, electrolyte imbalances,
certain medications and other medical conditions); or
- Members with first-degree relatives (siblings, parents, offspring) with LQTS or with a
defined LQTS mutation.
Aetna considers genetic testing for LQTS experimental and investigational for all other
indications.
Arkansas Blue Cross & Blue Shield (BCBSAR)
http://www.arkansasbluecross.com/members/report.aspx?policyNumber=2006022
Blue Cross & Blue Shield of Tennessee (BCBST)
http://www.bcbst.com/mpmanual/Genetic_Testing_for_Congenital_Cardiac_Channelopathies.htm
Cigna
http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/
mm_0193_coveragepositioncriteria_genetic_testing_for_long_qt_syndrome.pdf
- For confirmatory testing when the patient has been confirmed to have a prolonged QT
interval on electrocardiogram or Holter monitor, and an acquired cause has been ruled out.
- For predictive testing in EITHER of the following situations:
- When the individual is the reproductive partner of a person with a positive genetic test for
LQTS and the couple has the capacity and intention to reproduce.
- When there is evidence of EITHER of the following situations in a first-degree relative*:
- There is a history of prolonged QT interval on electrocardiogram or Holter
monitor, sudden death, or near sudden death and a genetic syndrome is suspected.
- There is a positive genetic test for LQTS.
All individuals undergoing genetic testing for any reason should have both pre- and post-test
genetic counseling with a physician or a licensed or certified genetic counselor.
*A first-degree relative is defined as a blood relative with whom an individual shares approximately
50% of his/her genes. First-degree relatives include the individual’s parents, full siblings and children.
Health Net, Inc.
https://www.healthnet.com/static/general/unprotected/pdfs/national/policies/genetic_testing_long_
qt_syndrome_apr_07.pdf
Health Net, Inc. considers genetic testing for LQTS medically appropriate when any of the
following criteria is met:
- The patient has been confirmed to have prolonged QT interval documented on
electrocardiogram and/or Holter monitor, and acquired causes have been ruled out (such
as drugs); or
- There is a positive family history of sudden death in an individual of <30 years of age, and
a genetic syndrome is suspected; or
- There is a positive genetic test in a first-degree relative (parents, full siblings and/or children).
HIP Plan of New York
https://www.hipusa.com/providers/ny/guidelines/pdf/lab/MG_Long_QT_Testing.pdf
Members are eligible for coverage of LQTS genetic testing when either of the following criteria
is documented as met:
- Presence of a prolonged QT interval on resting electrocardiogram or Holter monitor
(realtime cardiac monitoring acceptable for Medicare or Medicaid members) in the absence
of an identifiable etiology (heart failure, bradycardia, electrolyte imbalances, certain
medications, etc.).
- Members with first-degree relatives (children, siblings, parents) who have LQTS or a
known LQTS mutation.
Humana
http://apps.humana.com/TAD/TAD_New/returnContent.asp?mime=application/pdf&id=5298&issue=608
Humana members would be eligible under the plan for genetic testing for LQTS for ANY of
the following indications:
- Member has been confirmed to have a prolonged QT interval on electrocardiogram
or Holter monitor, and an acquired cause has been ruled out (such as heart failure,
bradycardia, electrolyte imbalances or certain medications); or
- Members with first-degree* relatives with LQTS or with a defined LQTS mutation.
*First-degree relatives include member’s parents, full siblings and children.
Tufts Health Plan
http://www.tuftshealthplan.com/providers/pdf/mng/Genetic_Testing_Long_QT.pdf
Tufts Health Plan may authorize coverage of genetic testing for LQTS if either of the following
criteria is met:
- The member has a prolonged QT interval on resting electrocardiogram or Holter monitor,
and evaluation by a cardiologist has not identified any causative factors.
- The member has a first-degree relative (parents, siblings and offspring only) with one of the
following:
- Diagnosis of LQTS
- Known LQTS mutation
Testing must be performed at a contracting laboratory facility when available.
Wellmark Blue Cross Blue Shield of Iowa
http://www.wellmark.com/e_business/provider/medical_policies/policies/
Genetic_Molecular_Testing_Misc.htm
Blue Cross and Blue Shield of Alabama
https://www.bcbsal.org/providers/policies/final/136.pdf
Premera Blue Cross of Alaska
https://www.premera.com/stellent/groups/public/documents/medicalpolicy/dynwat%3B9663_8679206_1796.pdf
HMSA Blue Cross and Blue Shield of Hawaii
http://www.hmsa.com/portal/provider/zav_pel.aa.gen.600mmrev.htm
Blue Cross of Idaho
http://www.bcidaho.com/providers/medical_policies/med/mp_20443.asp
Blue Cross and Blue Shield of Illinois
http://medicalpolicy.hcsc.net/medicalpolicy/home?corpEntCd=IL1&corpEntCd=IL1&ctype=POLICY
&cat=Medicine&path=/templatedata/medpolicies/POLICY/data/MEDICINE/MED207.110bu_2008-04-15#hlink
Blue Cross and Blue Shield of Mississippi
http://www.bcbsms.com/index.php?q=provider-medical-policy-search.html&action=viewPolicy&path=policy/
emed/Genetic%20Testing%20for%20Congenital%20Long%20QT%20Syndrome.html&keywords=long%20qt%20syndrome
Horizion Blue Cross and Blue Shield of New Jersey
https://services3.horizon-bcbsnj.com/hcm/MedPol2.nsf
Blue Cross and Blue Shield of New Mexico
http://medicalpolicy.hcsc.net/medicalpolicy/home?corpEntCd=NM1&corpEntCd=IL1&ctype=POLICY&cat=Medicine
&path=/templatedata/medpolicies/POLICY/data/MEDICINE/MED207.110bu_2008-04-15#hlink
Excellus Blue Cross and Blue Shield of New York
https://www.excellusbcbs.com/wps/wcm/resources/file/eb8bd803649f15e/gen_test_long_qt.pdf
Wellmark Blue Cross and Blue Shield of South Dakota
http://www.wellmark.com/e%5Fbusiness/provider/medical%5Fpolicies/policies/genetic%5Fmolecular%5Ftesting%5Fmisc.htm
Blue Cross and Blue Shield of Texas
http://medicalpolicy.hcsc.net/medicalpolicy/home?corpEntCd=TX1&corpEntCd=IL1&ctype=POLICY&cat=Medicine&path=
/templatedata/medpolicies/POLICY/data/MEDICINE/MED207.110bu_2008-04-15#hlink
Premera Blue Cross of Washington
https://www.premera.com/stellent/groups/public/documents/medicalpolicy/cmi_035163.pdf
ACC/AHA/ESC Guidelines (2006) Recommend
Genetic Testing to Identify ALL Mutation Carriers
in an LQTS Family and in an HCM Family
The ACC/AHA/ESC guidelines for management of patients with ventricular arrhythmias and
prevention of sudden cardiac death recommend genetic testing for numerous congenital cardiac
diseases including those that can identified by the FAMILION tests.
http://circ.ahajournals.org/cgi/reprint/114/10/1088
Long QT Syndrome:
“Genetic analysis is very important for identifying all mutation carriers within an LQTS family:
Once identified, silent carriers of LQTS genetic defects may be treated with beta-blockers for
prophylaxis of life-threatening arrhythmias. Furthermore, silent mutation carriers should receive
genetic counseling to learn about the risk of transmitting LQTS to offspring.”
“In patients affected by LQTS, genetic analysis is useful for
risk stratification and for making therapeutic decisions.
Although genetic analysis is not yet widely available, it is
advisable to try to make it accessible to LQTS patients.”
Catecholaminergic Polymorphic
Ventricular Tachycardia:
“Genetic analysis may help identify silent carriers of
catecholaminergic VT-related mutations; once identified
silent carriers may be treated with beta-blockers to reduce
the risk of cardiac events and may receive appropriate
genetic counseling to assess the risk of transmitting the
disease to offspring.”
Brugada Syndrome:
“Genetic analysis may help identify silent carriers of
Brugada syndrome-related mutations so that they
can remain under clinical monitoring to detect early
manifestations of the syndrome. Furthermore, once
identified, silent mutation carriers should receive genetic
counseling and discuss the risk of transmitting the disease to
offspring.”
Hypertrophic Cardiomyopathy:
"Genetic analysis is useful in families with HCM because whenever a pathogenic mutation is identified, it becomes possible to establish a presymptomatic diagnosis of the disease among family members and to provide them with genetic counseling to assess the risk of disease development and transmission of the disease to offspring. Genetic analysis may contribute to risk stratification in selected circumstances.”
For additional information, please contact
PGxHealth’s Customer Service team
at
877-2-PGxHealth
(877-274-9432)
or visit www.pgxhealth.com
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