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In the last 18 months, the Center for Medicare Advocacy, and other advocates around the country, have received many, many calls from older and disabled beneficiaries who can no longer obtain coverage for the Lidocaine Patch 5% from their Part D plans. Many have been using the Patch for at least a decade and are devastated when cut off from their primary source of pain relief for lack of a “medically accepted indication.”  The abrupt increase in denials of the Patch, beginning in 2015, is undoubtedly due to pressure from CMS to curtail coverage for off label drugs.

In order to be covered under Part D, drugs must be prescribed for a “medically accepted indication,” meaning their use for a particular disease must be approved by the FDA, or supported by one of three largely inaccessible Compendia, identified at Section 1927(g)(1)(B)(i) of the Social Security Act.  (The Act was subsequently modified to allow coverage of anti-cancer drugs if their use is supported in peer review journals.  Note that under Part B, all drugs, not just those used in an anti-cancer regimen, may be supported by peer reviewed literature.)

The Lidocaine Patch 5% is FDA approved for post hepatic neuralgia (shingles pain) and one of the compendia also approves it for diabetic neuropathy.  It is a highly effective pain reliever and its unique non-narcotic and non-addictive properties make it a benign alternative to opioids, without the risks and devastating side effects of opioids.[1] One out of every five drugs in the US is prescribed off-label; the Patch is often prescribed off-label to treat pain from spinal stenosis, degenerative disc disease, and severe osteoarthritis.

The fact that CMS is pushing Part D plans to deny coverage of the non-narcotic pain reliever Lidocaine Patch 5%, when the nation is facing a massive opioid crisis, seems misguided at best.  CMS’s efforts are undoubtedly an attempt to save money and bring plans into compliance with federal law that prohibits coverage of off-label drugs under Part D, but this action has had devastating consequences on many older and disabled Medicare beneficiaries. Without Part D coverage, most cannot afford to pay for the Patch out-of-pocket and have little choice but to rely on opiates for pain relief.

And by the way… should one of those individuals become addicted to opiates, and later require drug abuse treatment, the bad news is that Medicare doesn’t cover methadone maintenance therapy either!

Coverage denials for Lidocaine and other off-label drugs can be a shock and pose a major problem for people who become Medicare eligible and must transition from an Affordable Care Act (ACA) or a private insurance plan. When coverage has long been available based on their physician’s prescription, and that prescription is suddenly no longer available, these individuals lose access to effective medications. This results in confusion and harm to patients who can no longer get their medication – as well as dissatisfaction with Medicare, and contention between patients and providers. The discrepancy between coverage standards needs to change. Part D should use the same coverage standards as ACA. At the very least, Part D standards should not be more restrictive than Part B.

June 29, 2016 – J. Watrous

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