LCD L37126

Coverage Guidance

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member.

42 CFR §410.32(a) indicates that diagnostic tests may be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements).

Indications and Limitations of Coverage

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.

Summary of Evidence

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

Analysis of Evidence

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.

Bibliography

• Trevisson E, Dimauro S, Navas P, Salviati L. Coenzyme Q deficiency in muscle. Curr. Opin. Neurol. 2011;24 (5): 449–56.

• Sharma A, Fonarow GC, Butler J, et al. Coenzyme Q10 and Heart Failure. Circulation: Heart Failure 2016: 9:e002639.

• Madmani ME, Yusuf Solaiman A, Tamr Agha K, et al. Coenzyme Q10 for heart failure. Heart Group. Cochrane Database of Systematic Reviews. John Wiley & Sons 2014;(6): Art. no. CD008684.

• Mortensen SA, Rosenfeldt F, Kumar A, et al. The effect of coenzyme q10 on morbidity and mortality in chronic heart failure. Heart Failure. American College of Cardiology Foundation 2014:(6): 641–9.

• Banach M, Serban C, Sahebkar A, et al. Effects of coenzyme Q10 on statin-induced myopathy: a meta-analysis of randomized controlled trials. Mayo Clin Proc (Systematic Review and Meta-Analysis). Lipid and Blood Pressure Meta-analysis Collaboration Group.2015; 90 (1): 24–34.

• White, J. National Cancer Institute. PDQ® Coenzyme Q10. NCI, National Institutes of Health, U.S. Dept. of Health and Human Services. May 14, 2014.

• Armstrong, MJ; Miyasaki, JM. Evidence-based guideline: pharmacologic treatment of chorea in Huntington disease: report of the guideline development subcommittee of the American Academy of Neurology. Neurology. 2012;79 (6): 597–603.

• Markley HG. CoEnzyme Q10 and riboflavin: the mitochondrial connection. Headache (Review). 2012;52 Suppl 2: 81–7.

• Yorns WR, Hardison HH. Mitochondrial dysfunction in migraine. Semin Pediatr Neurol. 2013;20 (3): 188–93.

• Pringsheim T, Davenport W, Mackie G, et al. Canadian Headache Society guideline for migraine prophylaxis. Can J Neurol Sci. 2012;39 (2 Suppl 2): S1–59.

• Watts TLP. Coenzyme Q10 and periodontal treatment: is there any beneficial effect? British Dental Journal. Department of Periodontology and Preventive Dentistry, UMDS, Guy's Hospital London. 1995178 (6): 209–13.

• Rotig A, Appelkvist EL, Geromel V, et al. Quinone-responsive multiple respiratory-chain dysfunction due to widespread coenzyme Q10 deficiency. Lancet. 2000;356(9227):391-395

• Munnich A, Rotig A, Cormier-Daire V, Rustin P. Clinical presentation of respiratory chain deficiency. In: Scriver CR, Beaudet AL, Sly WS, Valle D,eds. The metabolic and molecular bases of inherited disease. 8th ed. Volume 2. New York: McGraw-Hill; 2001;2261-74.

• Lafuente R, González-Comadrán M, Solà I, et al. Coenzyme Q10 and male infertility: a meta-analysis. Journal of assisted reproduction and genetics. 2013;30 (9): 1147–56.