The clock is now ticking on the question of whether federal healthcare programs will pay for Edwards Lifesciences Corp.’s Edwards Sapien less-invasive heart valve.
A decision is expected by the Centers for Medicare & Medicaid Services, which administers the federal program, within 60 days regarding an important coverage determination for Sapien, which is delivered via a catheter rather than open-heart surgery.
Medicare’s decisions on coverage are seen as benchmarks for private insurance companies, and a decision by Medicare to deny or limit coverage of the Sapien could hurt sales.
Edwards recently filed its official response to the regulators’ proposal, commending the reviewing agency for proposing flexible coverage for transcatheter aortic valve replacement for all Food and Drug Administration-approved treatments.
“Such a policy benefits Medicare patients in need of treatment by providing uniform and timely access,” Edwards said.
But the company criticized a proposal to limit clinical trial insurance coverage to so-called superiority trials. The company said such a proposal would undermine efforts to promote clinical research to Medicare patients.
“There are also important, yet relatively small, patient populations that would be well-served by further studies and (who) may not get treatment if the proposed conditions are not revised,” Edwards said.
The company also said it believed the credentialing of facilities and heart teams “is far more relevant than traditional physician-based credentialing (for Sapien),” because it is using interdisciplinary teams to deliver the valve.
The company received FDA clearance for Sapien last November and has been rolling it out in selection locations nationwide including Hoag Memorial Hospital Presbyterian in Newport Beach.
Winning Sabra
Investors in Irvine-based Sabra Healthcare REIT Inc. and its competitors should see strong gains in the coming years as America ages, according to a new article on the Investopedia website.
The article quoted a statistic from the Centers for Medicare & Medicaid Services’ research arm showing that people over 75 spend nearly 200% more on healthcare than the average populations and that generalized healthcare expenses have been rising significantly faster than the overall economy or personal incomes for more than 40 years.
“More medical service equals more medical real estate,” the site’s Aaron Levitt wrote. “For investors, these assisted living facilities, hospitals and doctors’ offices could be the best way to play our aging population.”
Levitt said the number of Americans age 65 or older is expected to grow 36% through 2020, compared to a 9% growth rate for the general population. That means new hospitals and doctor’s offices for practicing medicine, as well as assisted-living centers for aging retirees, will need to be owned and operated, he said.
Sabra and Birmingham, Ala.-based Medical Properties Trust Inc. “could be the ticket” for investors looking for higher yields on their stocks, noting that both now yield more than 8%,” Levitt suggested.
Sabra came about in 2010 when Irvine nursing home operator Sun Healthcare Group spun off its real estate unit.
Mission CFO
Mission Hospital veteran Eileen Haubl has been named chief financial officer.
Haubl replaces Kenneth McFarland, who was promoted to chief executive in November after serving as interim chief executive following Peter Bastone’s departure last year. She has been with Mission for nearly a decade and is a 24-year veteran of St. Joseph Health System, the Orange-based parent of Mission, Fullerton-based St. Jude Medical Center and St. Joseph Hospital-Orange.
Haubl was financial director for the south division of St. Joseph’s Heritage Healthcare Foundation before going to Mission, and served as an executive director of finance in the system’s Sonoma County operating area.
Bits and Pieces
CalOptima Regional Extension Center in Orange said St. Joseph Heritage Medical Group and St. Jude Heritage Medical Group have achieved the “meaningful use vanguard” distinction for usage of electronic health records. The groups also received federal incentive payments as part of a national program that grew out of healthcare reform to improve the safety, quality and efficiency of patient care. … Foothill Ranch-based database builder Healthcare Data Solutions said it is working with RealScore LLC of New Albany, Ohio, to provide dental practice data…. Tenex Health Inc., a Lake Forest company that’s developing treatments for tendon pain, appointed orthopedic surgeon Bernard Morrey to the new position of chief medical officer. Tenex makes a device that debrides and aspirates diseased soft tissue and bone spurs in an outpatient setting using local anesthesia. …Gary Augusta, the former chief executive of Aliso Viejo healthcare and other types of technology booster group OCTANe, is a new director of Glendale-based health ser-vices company Apollo Medical Holdings Inc.
