Dec 12 (Reuters) - The Centers for Medicare & Medicaid

Services has directed private insurers providing Medicare

Advantage plans to cover Biogen's amyotrophic lateral

sclerosis drug Qalsody after finding instances of coverage

denial.

Qalsody received the U.S. Food and Drug Administration's

accelerated approval last year, but CMS said it found many

Medicare Advantage plans, which cover adults 65 years and older

or those with disabilities, were denying coverage by calling the

drug "experimental and investigational".

FDA's accelerated approval pathway allows for earlier

approval of drugs that treat serious conditions. Companies still

require to conduct confirmatory trials to confirm that the drug

actually provides a clinical benefit, following which the FDA

grants a traditional approval for the drug.

CMS does not make a distinction between drugs that are

marketed under an accelerated FDA approval versus a traditional

approval, the agency said in a memo dated Dec. 9, and directed

insurers to immediately discontinue the policy that denied

coverage for the drug.

The agency said it expects insurers to contact patients who

were inappropriately denied coverage of the drug to inform that

policies have changed.

The ALS Association, a patient advocacy group, late on

Wednesday said it began working with CMS to investigate "unjust

denials" of coverage for the drug by insurance companies, who

labeled the drug as "experimental".

The association urged people previously denied Qalsody by

their Medicare Advantage plan to contact their ALS specialist to

secure access to the treatment.