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Device Makers Weigh Pros, Cons of Healthcare Reform

Healthcare reform remains on the brains of Orange County industry executives even as lawmakers work on trying to get a final bill to President Obama’s desk by the end of the year.

Michael Mussallem, chief executive of Edwards Lifesciences Corp., an Irvine maker of heart valves and other devices, told attendees at the Reuters Health Summit in New York earlier this month that device makers are willing to pay for healthcare reform—but at a reasonable cost. They are hoping that their share of the bill—a tax on their revenue—will be less than a proposed $20 billion in a 10-year period.

Device maker advocates argue that a device tax could cut or eliminate profits, as many companies make slim profits on their sales.

“There’s no doubt that this will have an effect on every company’s bottom line,” Mussallem said.

Mussallem and others in the industry are working through trade groups, including Ad-vaMed and the Medical Device Manufacturers Association, to cut or eliminate the proposed tax.

In addition to the proposed tax, any healthcare insurance reform could push the device makers to lower prices, Mussallem said.

There are some upsides to proposed reform—at least for the customers of prosthetic limb maker Ossur Americas, according to President Mahesh Mansukhani.

Removing “pre-existing condition” restrictions on health insurance could allow amputees to get fair reimbursement for their prosthetics from Medicare or private insurers, Mansukhani said. Such restrictions often don’t allow amputees to get paid for more than one device, he said.

“If this healthcare reform truly does drive that out of existence, you’ll have a large part of our amputee base able to get products,” Mansukhani said.

While the reform stands to benefit individuals, the providers that buy Ossur’s products likely will be squeezed by the changes, he said.

NextGen Healthcare In-formation Systems, a suburban Philadelphia-based unit of Irvine medical software maker Quality Systems Inc., recently hosted a keynote session with former politicians Newt Gingrich and Howard Dean on healthcare reform.

They discussed issues such as the timeline for enacting legislation, what legislation may accomplish and healthcare delivery reform goals in the near and long term.

Quality expects to benefit from healthcare reform and President Obama’s economic stimulus package, which had $20 billion earmarked for healthcare information technology implementation, officials have said.

Spectrum’s Cancer Drug Sales

Sales of Spectrum Pharmaceuticals Inc.’s Zevalin drug to treat non-Hodgkin’s lymphoma, a form of blood cancer, made a big jump in the most recent quarter, the Irvine drug maker said.

Zevalin sales totaled $4.7 million in the third quarter, up 80% from a year earlier, when the drug still was being sold in a joint venture with Seattle-based Cell Therapeutics Inc.

Spectrum bought out Cell Therapeutics’ share in the joint venture earlier this year.

Overall, Spectrum’s third-quarter revenue was $7.1 million, compared to no revenue a year earlier. The company reported a loss of $8.4 million, narrowed from a loss of $8.8 million a year earlier.

Zevalin is clinically effective, but historically it has faced some challenges because of concerns about its radioactivity and difficulties getting reimbursement from insurance companies.

In October, the Centers for Medicare and Medicaid Services finalized a policy to allow reimbursement for Zevalin in Medicare’s hospital outpatient prospective payment system.

Getting reimbursement “removes a significant historical barrier” to Zevalin’s use, Chief Executive Rajesh Shrotriya said.

UnitedHealth’s $600K Grants

UnitedHealth Group Inc., a Minnesota-based managed care company with a large operation in Cypress, recently gave out more than $600,000 worth of grants for healthcare information technology projects in OC.

St. Joseph Hospital in Orange said it received a $317,242 grant from UnitedHealth Group to further develop practice management system software for community clinics. The software will be available to 47 community clinics that are operated by the 18 member organizations of the Coalition of Orange County Community Clinics, St. Joseph said.

UnitedHealth also gave $307,000 to the Providence Hearing and Speech Center, an Orange nonprofit and clinic that provides speech and hearing services to adults and children. Providence is going to put in an electronic medical records system with the money, it said.

Zenvia Data:

Aliso Viejo-based drug maker Avanir Pharmaceuticals Inc. recently released new data for its Zenvia drug candidate for treating uncontrollable fits of laughing or crying in patients with multiple sclerosis or Lou Gehrig’s disease. The data showed that Zenvia was generally safe and well-tolerated in 93% of patients who completed a 12-week treatment period. The data’s the last element needed for Avanir to submit a complete response to the Food and Drug Administration after it raised safety concerns, said Keith Katkin, its chief executive.

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