Sample Letter of Medical Necessity

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-Sample Letter of Medical Necessity

PROVIDER LETTERHEAD

Date

[Name of insurance]

Insurance address

RE:

FAMILION

Genetic Test for Inherited Cardiac Channelopathies

PGxHealth

Letter of Medical Necessity (LMN)

Patient Name:

Subscriber/ID Number:

To whom it may concern:

I am writing on behalf of my patient and your subscriber

[insert patient name]

, subscriber identification number

[insert ID number]

, date of birth

[insert DOB]

to request pre-determination/prior authorization for CPT4 codes

83891 (1 unit)

,

83898 (73 units)

,

83904 (73 units)

,

83909 (73 units)

and

83912 (1 unit)

with diagnosis code(s) of

[insert ICD9 codes].

Based on my evaluation and review of the available literature, I believe that the

FAMILION

genetic test, offered by PGx Health, is warranted and medically necessary for

[insert patient name]

. There is no less expensive alternative available to obtain this urgently needed information.

Patient history, diagnosis, and treatment

[Include information here regarding the patient’s condition and history related to his/her predisposition for inherited cardiac channelopathies. Include information on the treatment up to this point and why a screening 12-lead ECG would be insufficient to diagnose this patient and/or other appropriate history/documentation.]

Background information on cardiac channelopathies

Long QT Syndrome (LQTS) and Brugada Syndrome are the most common cardiac channelopathies, together affecting approximately 1/3,000 individuals in the United

States with 500-1,000 new carriers born each year. These syndromes cause cardiac arrhythmias in seemingly healthy and often young individuals and can lead to syncope, seizures, cardiac arrest, and sudden death. LQTS and Brugada Syndrome are two of the more common causes of sudden death in young people, resulting in 2,000 to 3,000 deaths per year.

1

In fact, because LQTS is unassociated with anatomic cardiac markers identifiable during life or at autopsy, its impact as a cause of premature death is probably underestimated.

2

While there is no cure, proper medical management including

1

combinations of lifestyle modification, β-blocker therapy and implantable cardioverterdefibrillators (ICDs) can reduce the risk of untoward events.

For patients who are potential carriers of one of the inherited cardiac channelopathy mutations, the

FAMILION

test allows physicians to

rule in definitively

the presence of

LQTS. The test results aid physicians in recommending appropriate treatment to reduce or eliminate cardiac events and lower the risk of premature death. It has been shown, for example, that the effectiveness of beta-blocker therapy varies with the nature of the genetic mutation.

3

FAMILION

test results also alert physicians and patients to avoid certain medications which have been shown to cause QT prolongation and increased risk of fatal arrhythmias such as

Torsades de Pointes

. Physicians can also test family members of affected individuals to determine their risk and need for intervention.

Effectiveness of the

FAMILION

genetic test for identifying mutations causing cardiac channelopathies

The

FAMILION

genetic test is a CLIA-certified test designed to identify mutations in ion channel genes in patients and their family members with inherited cardiac channelopathies such as Long QT Syndrome (LQTS) and Brugada Syndrome. The test is performed in a commercial laboratory that meets all applicable state and federal guidelines. The test has undergone extensive validation. At least 75% of individuals with

LQTS will have a mutation in one of the five cardiac ion channel genes included in the test. The

FAMILION

test has high analytical sensitivity; failure to detect an actual mutation in the 5 ion channel genes assayed is estimated to be <1%.

The value of genetic testing for these syndromes has been extensively documented in the medical literature. In 2006, the American Heart Association, the American College of

Cardiology and the European Cardiac Society issued joint Medical/Scientific Guidelines on the management of patients with ventricular arrhythmias and prevention of sudden cardiac death.

4

These recommend genetic testing for numerous congenital cardiac diseases including those that can identify the Long QT Syndrome and Brugada

Syndrome. In this report, the authors state:

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.”

Brugada Syndrome:

“Genetic analysis may help identify silent carriers of Brugada syndromerelated mutations so that they can remain under clinical monitoring to detect early manifestations of the syndrome. Furthermore, once identified, silent

2

mutation carriers should receive genetic counseling and discuss the risk of transmitting the disease to offspring.”

These recommendations rest on data from multiple investigators that document the inadequacy of the clinical evaluation, including history, physical examination, and ECG evaluation, for diagnosis of LQTS.

56

In addition, risk stratification for both the index patient and their family members is enabled by genetic testing.

7

Thank you for your time and consideration of my request. Please contact me if you wish to discuss this patient’s treatment plan or require additional information. I can be reached at

[insert telephone number].

Sincerely,

[Insert name and signature]

Enclosures:

1

The Sudden Arrhythmia Death Syndromes (SADS) Foundation: Long QT Syndrome Fact Sheet , July

2002. http://www.sads.org/LQTS.html

2

Maron BJ, et al. Impact of laboratory molecular diagnosis on contemporary diagnostic criteria for genetically transmitted cardiovascular diseases: hypertrophic cardiomyopathy, Long-QT syndrome, and

Marfan syndrome. A statement for healthcare professionals from the Councils on Clinical Cardiology,

Cardiovascular Disease in the Young, and Basic Science, American Heart Association].

Circulation

1998;98:1460-1471.

3

Moss AJ, et al. Effectiveness and Limitations of β-blocker therapy in congenital Long-QT syndrome.

Circulation

2000;101:616-623.

4

Zipes D, et al. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular

Arrhythmias and the Prevention of Sudden Cardiac Death): A Report of the American College of

Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines. Developed in Collaboration With the European Heart Rhythm Association and the

Heart Rhythm Society.

Circulation 2006;114;e385-e484

5

Vincent GM. The Long-QT syndrome—bedside to bench to bedside. New Engl J Med 2003:348;1837-

1838.

6

Priori SG et al. Low penetrance in the Long-QT Syndrome: clinical impact.

Circulation

1999;99:529-533.

7

Zareba W et al. Influence of the genotype on the clinical course of the Long-QT syndrome. New Engl J

Med 1998:339;960-965.

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