BULLET. Patient trapped with sudden $176,000 drug bill due to an obscure Medicare MAC policy change. +Lawsuit.
Medicare policy makes extensive use of "incident to" services. For example, there is a benefit for durable medical equipment like drug pumps and the drugs they pump are actually secondary tag-alongs to the DME benefit for the pump. (Weird!). Drugs that are administered in physician offices, like chemotherapy infusions, are covered "incident to" the service of a physician.
There are some rules around this. The drug must be NOT self-administered HALF the time or more. MACs are required to keep and update lists of injectible drugs that are NOT self administered, and thus eligible for office payment. CMS defines this across all patients; if one patient is quadriplegic, for example, that doesn't matter if 51% of all patients self administer the drug (such as insulin).
MACs don't always agree (SAD lists can differ) and big debates sometimes occur. See a sample "excluded" list here.
MEDPAGE TODAY has a detailed article (by Cheryl Clark) about a patient who faces a major crisis because his drug was switch to "self administered, not payable in office" status by the MAC where he and his doctor live. (Article may require email registration). He got a bill for $176,000, whereas up to that point, his 80% payments were covered by CMS and his 20% payments were covered by his medigap plan. A lawsuit by the Center for Medicare Advocacy is in flight.
Find the article here:
Another example of a 50% rule separates physician services and other services. Medicare classifies a physician service IF AND ONLY IF a physician signs performs the service more than 50% of the time. (42 CFR 415.102 . The rule doesn't state 51% numerically but this is how CMS implements the word "ordinarily" done by a physician.)
The pathology rule is even tougher, the test/service must REQUIRE (quote - unquote) the service of a pathologist (415.130). Back in 2012/2013, some stakeholders wanted the then-new genetic test codes to be on the physician fee schedule, but CMS determine that genetic tests did not "require" physician signout (the lab director can be a PhD). (My 2012 white paper still downloadable here.)
Medicare unexpectedly changed its policy on the drug Stelara, classifying it as "self-administered" (SAD) on October 15, 2021. This led to retirees like George Beitzel, suffering from Crohn's and Parkinson's diseases, facing unexpected bills of up to $176,000 for previously covered injections. The Center for Medicare Advocacy filed a class-action lawsuit against this policy shift, arguing for notice, cost waivers, and professional administration options for patients unable to self-administer. Thousands of Medicare beneficiaries may be affected, raising concerns about the impact of such changes on patients' health and financial well-being.
Burdens patients' lives.
I fed a CMS MAC SAD Article to Chat GPT and asked it to figure it out and explain it. Here.