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

ED SILVERMAN ed.silverman at comcast.net
Mon Apr 9 13:48:18 PDT 2018


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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