[Ip-health] Yikes! U.S. Medicare sets outpatient rate for CAR T reimbursement.

Alicia Mundy amundy at aliciamundy.com
Mon Apr 9 14:06:06 PDT 2018


This is a crazy situation - it’s like choosing lottery balls while they’re still in the spinner 

Alicia Mundy
Washington 
202-360-3950



> On Apr 9, 2018, at 4:48 PM, ED SILVERMAN <ed.silverman at comcast.net> wrote:
> 
> i heard from cms, although its like pulling teeth to get what might be a straight answer
> 
>> On April 9, 2018 at 4:36 PM James Love <james.love at keionline.org> wrote:
>> 
>> 
>> Politico is reporting a much much different figure on the CMS patient
>> co-payment for CAR T., and the AP earlier also seemed to think the Reuters
>> report was wrong. Both are sourced from CMS.
>> 
>> One issue, that bears clarification, is if CMS considers CAR T a medical
>> activity, or a drug, when determining the co-payment, or if they apply
>> different rules to the part that is a service and some other rule to the
>> part that is a product.
>> 
>> To the extent that CAR T is a service, it may also have consequences for
>> patents, since you cannot enforce a patent against a medical practitioner
>> performing an exempt medical activity.
>> 
>> 
>> 
>> Jamie
>> 
>> 
>> 
>> On Fri, Apr 6, 2018 at 12:11 AM, James Love <james.love at keionline.org>
>> wrote:
>> 
>>> 
>>> ​The NIH won't enforce oblgiations to make its NIH funded inventions
>>> "available to the public on reasonable terms, including the new CAR T
>>> treatments.
>>> 
>>> Reuters reports Medicare reimbursement policies for Yescarta and Kymriah.
>>> 
>>> * The minimum patient co-payment for Yescarta is $79,076.
>>> 
>>> * For Kymriah the co-payment is $100,168.
>>> 
>>> 
>>> https://www.reuters.com/article/cancer-medicare-
>>> yescarta/u-s-medicare-sets-outpatient-rate-for-yescarta-
>>> reimbursement-idUKL2N1RI17D
>>> 
>>> 
>>> U.S. Medicare sets outpatient rate for Yescarta reimbursement
>>> Deena Beasley
>>> 
>>> April 5 (Reuters) - Medicare, the U.S. government healthcare program for
>>> the elderly and disabled, will pay hospitals close to its standard mark-up
>>> rate for administering cell therapy Yescarta for cancer outpatients, who
>>> will have a co-payment of nearly $80,000, according to the Centers for
>>> Medicare & Medicaid Services (CMS).
>>> 
>>> Additional Medicare reimbursement for inpatients has been requested by
>>> Yescarta maker Gilead Sciences Inc and Novartis AG, which makes Kymriah, a
>>> similar therapy. Both therapies were approved last year by the Food and
>>> Drug Administration and are being used by growing number of major cancer
>>> centers.
>>> 
>>> The CMS has not made a decision on the requests, it said in an emailed
>>> statement on Thursday.
>>> 
>>> Reimbursement has been a major issue for investors because the high costs
>>> of the so-called CAR-T therapies could affect usage, especially for the
>>> Medicare population.
>>> 
>>> The therapies involve drawing white blood cells from a patient, processing
>>> them in the lab to target cancer, and infusing the cells back into the
>>> patient.
>>> 
>>> Most patients are first admitted to the hospital because the treatments
>>> may have life-threatening side effects, and inpatient services can bring
>>> the total cost to as much as $1.5 million.
>>> 
>>> For outpatient drugs, Medicare typically reimburses providers at the net
>>> price (after discounts and rebates) plus 6 percent. New drugs are paid at
>>> the manufacturer’s wholesale acquisition cost plus 6 percent for the first
>>> three quarters.
>>> 
>>> As of April 1, CMS said it would pay $395,380 to health providers who use
>>> Yescarta, with a list price of $373,000, on an outpatient basis. The
>>> minimum patient co-payment for Yescarta is $79,076.
>>> 
>>> For Kymriah, with a list price of $475,000, the Medicare payment rate is
>>> $500,839, and the co-payment is $100,168.
>>> 
>>> For inpatients, Medicare bundles CAR-Ts into the payment for a hospital
>>> stay. Gilead and Novartis have filed for additional “new technology add-on
>>> payments” from Medicare to cover the cost of cell therapies in the hospital.
>>> 
>>> Yescarta is approved for patients with a type of lymphoma who have failed
>>> to respond to other therapies, while Kymriah is approved for children and
>>> young adults with acute lymphoblastic leukemia that has not responded to
>>> other treatments.
>>> 
>>> Novartis has also filed for use of Kymriah in lymphoma patients and a
>>> decision from the FDA is expected by mid-year. (Reporting by Deena Beasley;
>>> Editing by Richard Chang)
>>> 
>>> 
>>> 
>> 
>> 
>> --
>> James Love. Knowledge Ecology International
>> http://www.keionline.org/donate.html
>> KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
>> +41.76.413.6584, twitter.com/jamie_love
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