SUPERSEDED Local Coverage Determination (LCD)

Lab: Coenzyme Q10 (CoQ10)

L37022

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Superseded
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Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L37022
Original ICD-9 LCD ID
Not Applicable
LCD Title
Lab: Coenzyme Q10 (CoQ10)
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL37022
Original Effective Date
For services performed on or after 07/10/2017
Revision Effective Date
For services performed on or after 02/25/2021
Revision Ending Date
04/24/2024
Retirement Date
N/A
Notice Period Start Date
05/25/2017
Notice Period End Date
07/09/2017

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

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).

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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 (Rationale for Determination)

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.

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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N/A

Revenue Codes

Code Description

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N/A

CPT/HCPCS Codes

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N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

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Additional ICD-10 Information

General Information

Associated Information
N/A
Sources of Information
N/A
Bibliography
  1. Trevisson E, Dimauro S, Navas P, Salviati L. Coenzyme Q deficiency in muscle. Curr. Opin. Neurol. 2011;24 (5): 449–56.
  2. Sharma A, Fonarow GC, Butler J, et al. Coenzyme Q10 and Heart Failure. Circulation: Heart Failure 2016: 9:e002639.
  3. 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.
  4. 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.
  5. 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.
  6. White, J. National Cancer Institute. PDQ® Coenzyme Q10. NCI, National Institutes of Health, U.S. Dept. of Health and Human Services. May 14, 2014.
  7. 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.
  8. Markley HG. CoEnzyme Q10 and riboflavin: the mitochondrial connection. Headache (Review). 2012;52 Suppl 2: 81–7.
  9. Yorns WR, Hardison HH. Mitochondrial dysfunction in migraine. Semin Pediatr Neurol. 2013;20 (3): 188–93.
  10. 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.
  11. 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.
  12. 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
  13. 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.
  14. 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.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
02/25/2021 R9

Under CMS National Coverage Policy updated description for regulation Title XVIII of the Social Security Act, §1862(a)(1)(A) to read “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 to improve the functioning of a malformed body member” and updated description for regulation 42 CFR §410.32(a) to read “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”. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
06/01/2020 R8

Annual Validation was performed and no changes were made.

  • Provider Education/Guidance
11/07/2019 R7

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Lab: Coenzyme Q10 (CoQ10) A55709 article.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
10/03/2019 R6

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision.

  • Provider Education/Guidance
01/10/2019 R5

Added "Lab:" to the title. Removed reference #7 and corrected reference numbering throughout the policy.

  • Other
04/12/2018 R4

Removed reference #9 in the Bibliography section because it was withdrawn. Also removed the content referencing #9. Corrected bibliography numbering and references 10-15 throughout the policy.

  • Provider Education/Guidance
02/26/2018 R3 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
01/29/2018 R2 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
07/13/2017 R1

There is no change in coverage for this policy. Palmetto GBA added the newly required section headers, Summary of the Evidence and Bibliography as well as an Analysis of Evidence. 

  • Provider Education/Guidance
N/A

Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
04/16/2024 04/25/2024 - N/A Currently in Effect View
02/15/2021 02/25/2021 - 04/24/2024 Superseded You are here
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