This is a non-coverage policy for serum or other body fluid testing for levels
of Coenzyme Q10 (CoQ10 or Q10), also known as ubiquinone, ubidecarenone,
coenzyme Q, for all diseases. Q10 supplementation is purported to:

  * Prolong life and prevent age-related functional declines
  * Inhibit the development and/or progression of atherosclerosis
  * Have value as an adjunct to conventional medical therapy in the treatment of congestive heart failure, conventional angina therapy, and cancer
  * Is protective against myocardial damage during ischemia-reperfusion during cardiac surgery
  * Is beneficial in the treatment of hypertension, cardiovascular disease and diabetes
  * Plays a role in neurodegenerative diseases, such as Parkinson's disease, Huntington's disease, Friedreich's ataxia
  * Enhance athletic performance
  * Enhance fertility

However, scientific indications for Q10 supplementation, except as anecdotally
reported for rare mitochondrial encephalomyopathies, are poor and/or
controversial, as are indications for Q10 testing by any methodology.  
  
Q10 is a highly lipophilic molecule with a chemical structure similar to
vitamin K. Its most prominent role is to facilitate the production of
adenosine triphosphate (ATP) in the mitochondria by participating in redox
reactions within the electron transport chain. Two major factors lead to
deficiency of Q10 in humans: reduced biosynthesis and increased use by the
body. As many as 12 genes control biosynthesis; Q10 levels may also be
controlled by other genetic defects not directly related to Q10 biosynthesis.

**Heart disease**

Q10 shares a biosynthetic pathway with cholesterol. An intermediary precursor
of Q10 is inhibited by some beta blockers, antihypertensive medications and
statins, but the role of statins in deficiencies is controversial.1  
  
Some chronic disease conditions (cancer, heart disease, etc.) are also thought
to reduce the biosynthesis of and increase the demand for CoQ10 in the body,
but there is no definite data to support these claims.2 A 2014 Cochrane
Collaboration meta-analysis found "no convincing evidence to support or
refute" the use of CoQ10 for the treatment of heart failure.3 Evidence with
respect to preventing heart disease in those who are otherwise healthy is also
poor.4  
  
 **Statin myopathy**

Q10 has been routinely used to treat muscle breakdown associated as a side
effect of use of statin medications. However, evidence from randomized
controlled trials does not appear to support the idea that CoQ10 is an
effective treatment for statin myopathy.5  
  
 **Cancer**

No large well-designed clinical trials of CoQ10 in cancer treatment have been
done.6 The National Cancer Institute identified issues with the few, small
studies that have been done stating, "the way the studies were done and the
amount of information reported made it unclear if benefits were caused by the
CoQ10 or by something else".6 The American Cancer Society has concluded,
"CoQ10 may reduce the effectiveness of chemo and radiation therapy, so most
oncologists would recommend avoiding it during cancer treatment."  
  
 **Neuromuscular and Neurologic Diseases**

Available evidence suggests that "CoQ10 is likely ineffective in moderately
improving" the chorea associated with Huntington's disease.7  
  
 **Migraine headache**

Supplementation of CoQ10 has been found to have a beneficial effect on the
condition of some sufferers of migraine. An explanation for this is the theory
that migraines are a mitochondrial disorder,8 and that mitochondrial
dysfunction can be improved with CoQ10.9 The Canadian Headache Society
guideline for migraine prophylaxis recommends, based on low-quality evidence,
that 300 mg of CoQ10 be offered as a choice for prophylaxis.10  
  
 **Dental disease**

A review study has shown that there is no clinical benefit to the use of CoQ10
in the treatment of periodontal disease.11 Most of the studies suggesting
otherwise were outdated, focused on in vitro tests, too few test subjects
and/or erroneous statistical methodology and trial setup, or were sponsored by
a manufacturer of the product.  
  
 **Mitochondrial encephalomyopathies**

This group of genetic disorders results from abnormalities in the function of
the mitochondrial transport chain. Tissue Q10 deficiencies have been found in
a very small subpopulation of individuals with mitochondrial
encephalomyopathies.12 In these rare individuals, Q10 supplementation has
resulted in clinical improvement.13  
  
 **Male infertility**  
Q10 can improve some measurements regarding sperm quality. However, there is
no evidence that Q10 increases pregnancy rates or live births.14

_Level of Evidence_

Quality - 2C

Strength - Weak

Weight - Weak

Based on the results of multiple articles representing multiple conditions,
the scientific evidence to support coverage of Q10 for any purpose is
controversial and/or limited for all diseases. Thus, testing for Coenzyme Q10
is not reasonable and necessary as a Medicare benefit. Randomized controlled
studies are recommended to demonstrate clinical utility. Consequently, testing
for Q10 is not a Medicare benefit.