FEATURE
MEDICARE AND THE Voice of the Patient
Tom James, MD
I
n September, I was fortunate enough to
be invited to be one of 14 panelists at a
hearing called by the Centers for Medicare
and Medicare Services (CMS) to review
one aspect of the reporting on a break-
through technology - Chimeric Antigen Re-
ceptor T-cell therapy (CAR-T). The Medicare
Evidence Development & Coverage Advisory
Committee (MED CAC) was organized in 1999, as an independent
body to advise CMS on specific clinical topics related to technology.
CMS may hold one to six reviews a year. Panelists may serve up to
two years. Because of conflicts of interest, a panelist may be exclud-
ed. The MED CAC panels are drawn from academic institutions,
pharmacy consultants, private practitioners and payers. Some of
the panelists know the technology well; others are generalists but
do know how to evaluate research data. Prior to being accepted to
participate in the panel, we all went through criminal background
checks, evaluation of our finances to the point of what was in our
mutual funds, and a study of our history of federal program en-
gagements.
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LOUISVILLE MEDICINE
With only one prior conference call, we were told to report to
CMS headquarters at 6:30 in the morning. As I swung my little Ford
hybrid from the suburban streets outside of Baltimore onto Security
Blvd, I was stopped at the gate. A guard inspected my backpack,
looked in my trunk and under the hood of my car before gauging
that I was not a national security threat. We then went through a
separate TSA-style evaluation; we signed a document promising we
wouldn’t steal Medicare secrets. Finally, we were led into a conference
room for our briefing and breakfast. There were 10 of us as regular
panelists and four specialty interest panelists including a transplant
physician, an industry representative, a medical oncologist and a
patient who had CAR-T therapy eight years ago.
Finally, we were led into an auditorium where we were seated
alphabetically with the four specialty panelists placed at the far
end of the tables. The live streaming of the hearing made me think
that this was probably as exciting as C-SPAN. Promptly at 8:00 am,
our chairman from Yale Medical School called the panel to order.
Following the perfunctory introductions and opening statements,
we got to the “fun.”
Our charge for this panel was to consider whether Patient Report-