Congress Extends 2007 Reimbursement Rates for Radioimmunotherapies for 18
Months
SEATTLE, July 9 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI)
(Nasdaq and MTA: CTIC) announced that the Medicare Improvements for Patients
and Providers Act of 2008, as passed by the U.S. House of Representatives on
June 24, 2008 and the U.S. Senate on July 9, 2008, would continue the 2007
reimbursement methodology for therapeutic radioimmunotherapies for an
additional 18 months with a start date of July 1, 2008. In December,
Congress froze reimbursement rates at the 2007 level for six months after
the Centers for Medicare & Medicaid Services (CMS) had released rates for
2008 that were lower than the acquisition cost for radioimmunotherapies like
Zevalin(R) (Ibritumomab Tiuxetan). Manufacturers of radioimmunotherapies and
CMS have been in discussion on a payment policy that more accurately
reflects hospital costs associated with the therapy. These drugs are used to
fight relapsed non-Hodgkin's lymphoma (NHL), and can provide some patients
with additional therapeutic options.

On July 3, 2008 CMS posted the Hospital Outpatient Prospective Payment
System proposed rulemaking for Calendar Year 2009. In the rulemaking, CMS
proposed to pay Zevalin and other similar products based on the Average
Sales Price (ASP) methodology which is currently used for drugs and
biologicals. CTI plans to submit a public comment in support of the
proposal.

"We are pleased law makers have listened to the voice of patients and
healthcare providers who want access to these important anti-cancer
therapies," said James A. Bianco, M.D., President and CEO of CTI. "We
continue to work with Congress and CMS to establish a permanent payment
methodology for reimbursing radioimmunotherapies, and look forward to the
President signing the bill into law."

CTI purchased the U.S. sales, marketing, and development rights to Zevalin
in late 2007 from Biogen Idec, Inc. Recently CTI reached an agreement with
Bayer Schering Pharma, which has rights to Zevalin outside the United
States, for access to pivotal trial data from the First-line Indolent Trial
(FIT), which can potentially be used to expand the label in the U.S.

beato te che ancora ci credi

:-)

Senate passes doctor reimbursement bill

AP foreign, Wednesday July 9 2008 WASHINGTON (AP) - The Senate, with
Democrat Ted Kennedy casting a crucial vote, approved legislation by a
veto-proof margin Wednesday that would void a 10.6 percent pay cut for
doctors treating Medicare patients.

The bill now goes to the White House. The House already approved the
measure, but a Senate vote two weeks ago fell one vote short of the 60 votes
needed to limit debate. Kennedy, undergoing radiation and chemotherapy
treatments for brain cancer, was not present then.

His presence Wednesday was instrumental as the vote to limit debate was
approved 69-30. Under a previous agreement, once the 60-vote threshold was
met, the bill was considered approved.

Nine Republicans voted for the measure after sitting out the vote two weeks
ago or voting previously against limiting debate. President Bush's advisers
have said they will recommend that he veto the bill.

Lawmakers are under pressure from doctors and the elderly patients they
serve to void the cut, which kicked in July 1 because of a funding formula
that establishes lower reimbursement rates when Medicare spending levels
exceed established targets. Some doctors say they'll quit taking new
patients if the cuts stand.

Medicare officials will not make any payments at the reduced rate until July
15, at the earliest.

Every year, Congress confronts the task of voiding Medicare rate cuts for
doctors. Lawmakers always find the task difficult because they pay for the
measure by trimming payments to other health care providers.

This year, Democrats homed in on cutting the Medicare Advantage program,
which serves 9 million elderly and disabled patients. The Bush
administration and Republicans like Medicare Advantage because it lets the
elderly and disabled choose to get their health benefits through private
insurers rather than through traditional Medicare. Democrats contend that
government payments to the insurers are too generous.

If the bill becomes law, the Congressional Budget Office projected that
insurers would get about $13.5 billion less over the next five years through
Medicare.

"C'è un GAP aperto a 0,22!!!!®" <Ziosegnalll@Zio.itt> ha scritto nel
messaggio news:nTadk.23980$Ca.15111@twister2.libero.it...
> beato te che ancora ci credi
> :-)
mi aspetto lo spin off entro fine mese con l'arrivo dell'uomo bayer come
presidente

Il Congresso statunitense estende i tassi di rimborso dei farmaci
radioimmunoterapici per 18 mesi
9 luglio 2008, Seattle e Bresso - Cell Therapeutics, Inc. (CTI) (NASDAQ e
MTA: CTIC) ha
annunciato oggi che il Medicare Improvements for Patients and Providers Act
del 2008, come approvato
dalla Camera statunitense il 24 giugno 2008 e dal Senato statunitense il 9
luglio 2008, estenderebbe la
metodologia di rimborso del 2007 per i farmaci radioimmunoterapici per
ulteriori 18 mesi a partire dal
1° luglio. Nello scorso dicembre il Congresso aveva mantenuto le quote di
rimborso in vigore nel 2007
per i primi sei mesi del 2008, dopo che il Centers for Medicare and Medicaid
Services (CMS) aveva
proposto per il 2008 nuovi tassi di rimborso per l'uso di farmaci
radioimmunoterapici quali Zevalin®
(Ibritumomab Tiuxetan) al di sotto del loro costo di acquisto. I produttori
di farmaci
radioimmunoterapici ed il CMS hanno discusso per definire una procedura di
rimborso che rifletta più
accuratamente i costi ospedalieri associati alla terapia. Tali farmaci sono
usati nel trattamento del
linfoma non-Hodgkin recidivato e per certi pazienti costituiscono un'opzione
terapeutica aggiuntiva.
Il 3 luglio 2008 il CMS ha pubblicato la modifica proposta per l'Hospital
Outpatient Prospective
Payment System per l'anno 2009. Nella modifica della normativa il CMS ha
proposto il rimborso di
Zevalin, e di altri farmaci similari, sulla base di una metodologia di
Average Sales Price (ASP),
attualmente utilizzata per farmaci e biofarmaci. La Società prevede di
presentare un commento pubblico
a supporto della proposta.
"Siamo lieti che i legislatori abbiano ascoltato la voce dei pazienti e dei
fornitori che vogliono accedere
a queste importanti terapie" ha dichiarato James A. Bianco, Presidente e CEO
di CTI. "Continuiamo a
collaborare con il Congresso e con CMS per sviluppare una metodologia
permanente di rimborso per i
farmaci radioimmunoterapici. Attendiamo che il Presidente firmi la proposta
e che la legge entri in
vigore".
CTI ha acquisito da Biogen Idec, Inc. nel dicembre 2007 i diritti di
sviluppo e commercializzazione di
Zevalin negli Stati Uniti. Recentemente CTI ha siglato un accordo con Bayer
Schering Pharma, che
possiede i diritti per la commercializzazione di Zevalin al di fuori degli
Stati Uniti, per l'accesso ai dati
dello studio clinico FIT, che potrebbero essere utilizzati per una domanda
di potenziale estensione
dell'indicazione d'uso di Zevalin negli Stati Uniti.