Full article reprinted from "The Gray Sheet" - December 1, 2008
Find out how CMS has received four new applications for new technology add-on payments for fiscal 2010, plus two re-applications for devices that were considered last year.
Full article reprinted from "The Gray Sheet" - December 1, 2008
Medicare "add-on" payments are available for a new therapy if the manufacturer can show the product offers a substantial clinical improvement over existing alternatives. The applicant must also show that the diagnosis group the device would fall into without the extra payment would provide inadequate reimbursement, but that hospital data establishing the actual cost of the new technology is not yet available.
The current batch of applicants will have a chance to argue their case at a new technology town hall meeting, open to the public, on Feb. 17, 2009. The applications were due Nov. 17 and were announced on the CMS Web site Nov. 25.
CMS' decisions on the requests will be part of the 2010 inpatient rule, to be drafted this coming spring and finalized in August.
CMS now requires devices to be FDA-approved by July 1 of the year prior to the award in order to be considered for an add-on payment (1"The Gray Sheet" Aug. 11, 2008, p. 9).
TherOx And Emphasys Try Again
In 2007, four firms applied for add-on payments, but SynCardia Systems' CardioWest temporary total artificial heart was the only device granted one. CMS denied the other three applicants because the devices were not yet FDA-approved and therefore did not meet CMS' "newness" criterion for an add-on payment (2"The Gray Sheet" Aug. 11, 2008, p. 10).
Two of the firms denied last year, TherOx and Emphasys Medical, are applying again.
TherOx is asking for an add-on payment for its Downstream SuperSaturatedOxygen Therapy (SSO2) system. The company expects FDA to approve the device in the second quarter of 2009, in time to qualify for an add-on payment in FY 2010.
The Downstream SSO2 is designed to minimize myocardial damage following a coronary stent placement to treat an acute myocardial infarction. The device delivers superoxygenated blood directly to the area of myocardia that is dying from of lack of oxygen due to the infarction.
The 301-patient AMIHOT II trial demonstrated the ability of SSO2 therapy with Downstream to reduce infarct size without increasing major adverse events.
Emphasys Medical failed to secure an add-on payment for its Zephyr Endobronchial Valve (EBV) last year because the device was not approved, but is optimistic FDA will approve it in time to get an add-on payment for FY 2010.
In its add-on application, Emphasys does not estimate when FDA will approve Zephyr EBV, but notes that the agency's Anesthesiology and Respiratory Therapy Devices advisory panel is meeting Dec. 5 to review the device, so an approval could come before the final inpatient rule is released in August (3"The Gray Sheet" Nov. 17, 2008, p. 7).
Zephyr EBV is a valve implanted with a catheter to treat patients with severe emphysema. It diverts airflow from an over-expanded region of the lung into a healthier adjacent lobe. Reducing the volume of the hyperinflated lobe improves the patient's lung function, exercise capacity and quality of life, according to Emphasys.
Emphasys' 321-patient pivotal VENT trial showed EBV therapy is superior to optimal medical management for improving physiologic function and exercise tolerance in patients with severe emphysema.
Four New Applications For 2010
Monteris Medical is asking for an add-on payment for its auto laser interstitial thermal therapy (AutoLITT ) system, a magnetic resonance-image guided laser system for precision thermal destruction of brain tumors.
The company predicts FDA will approve AutoLITT in December and expects to sell 150 systems in the U.S. in fiscal 2010, of which about 45% will be used for patients in the Medicare population.
InfraReDx also seeks an add-on payment for its LipiScan intravascular near infrared spectroscopy (INIRS) coronary imaging system, which FDA cleared via 510(k) in April 2008.
LipiScan can help identify "vulnerable plaques" - coronary plaques with a lipid core; the plaques are susceptible to rupture and release of emboli that can cause myocardial infarction or stroke. LipiScan can also measure the total amount of lipid core plaques in the coronary artery to create a Lipid Core Burden Index.
The company says that since LipiScan was cleared in April, physicians have reported that INIRS findings have triggered therapy changes in about a quarter of their patients. The most common application of INIRS is to determine the length of stent needed to treat an artery, because the INIRS image, unlike a standard angiogram, often reveals the presence or absence of vulnerable plaques adjacent to the flow-limiting plaque.
Spiration is applying for an add-on payment for its Spiration IBV minimally invasive valve system, designed to control prolonged air leaks in the lung following lobectomy, segmentectomy or lung volume reduction surgery. Spiration received an FDA humanitarian device exemption in October 2008 (4"The Gray Sheet" Nov. 3, 2008, p. 19).
Finally, Genzyme Oncology has applied for a new technology add-on payment for its Clolar (clofarabine) injection, an intravenously infused chemotherapeutic agent in the treatment of acute leukemia.
FDA granted PMA approval for Clolar for pediatric patients in 2004; supplemental approval is pending for treatment of adult patients with acute myeloid leukemia.
Genzyme says Clolar is a new treatment option for older patients with acute myeloid leukemia, a population that usually has a poor prognosis and is often resistant to currently available chemotherapy agents.
The company is submitting data showing that Clolar has "acceptable tolerability" and is effective at inducing high remission rates in older acute myeloid leukemia patients with at least one adverse risk factor, and therefore represents a significant clinical improvement over existing alternatives.
- Reed J. Miller
Sign up for your 30-day, risk-free trial of "The Gray Sheet" today.
"The Gray Sheet" gives you 51 issues per year filled with useful articles that will help you meet your business and regulatory objectives.
