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| FDA OKs Staar's Implantable Collamer Lens
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Another accommodative IOL is set to enter the market this year, as Staar Surgical announced last week that the FDA has approved the company's Myopic Visian Implantable Collamer Lens.
The company says it expects to begin shipping the ICLs, indicated for myopia correction in adults, to trained doctors in six weeks to eight weeks. According to the company, the Visian "is the only minimally invasive foldable lens of its kind approved for the U.S. commercial market." The benefits of the new lens, according to Staar:
The proprietary Collamer material is "highly biocompatible."
The foldable design "allows an incision up to 50 percent smaller than competing technology."
The ICL's placement behind the iris provides a "more aesthetically pleasing outcome."
"We believe the ICL offers patients and their doctors opportunities to achieve higher quality visual outcomes compared with competing technology," says David Bailey, president and CEO of Staar Surgical. "As we have done internationally, we will guide doctors through our training and certification process, which includes proctoring the first five surgeries. Currently, we have more than 860 surgeons who have completed the first phase of training and are ready to be proctored by the five application specialists that we have on staff."
In addition to the United States, the ICL is approved for sale in 41 countries, including those of the European Union, and has been implanted successfully in more than 40,000 eyes worldwide.
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| ACG: Nation's Largest Insurer Won't Cover General Anesthesia for Endoscopies
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WellPoint, the nation's largest private health insurer, has decided to "eliminate payment of the costs of an anesthesiologist in conjunction with endoscopic procedures," according to the American College of Gastroenterology. The move, which the ACG says affects patients in California, Indiana and other states, would effectively eliminate the administration of general anesthesia to patients who require it in procedures such as colonoscopies and upper GI endoscopies.
In a letter from John W. Popp Jr., MD, FACS, the ACG's immediate past president, to WellPoint CEO Larry C. Glasscock, Popp notes that WellPoint cites the "Tri-Society Policy Statement on Nurse Administration Propofol/Conscious Sedation," which calls for trained RNs to be allowed to administer propofol for conscious sedation during some endoscopic procedures, as one reason for its decision.
But Dr. Popp, one of the co-authors of the Tri-Society Statement, says that WellPoint has misinterpreted the message of the statement, which both endorses RN-administered propofol sedation and recognizes that "there are definitely some patients (albeit a minority) who need to have an anesthesiologist to administer general anesthesia for a colonoscopy."
Further, writes Dr. Popp, the physician, not the insurer, is the appropriate person to determine which patients may require general anesthesia for endoscopy.
WellPoint did not return requests for comment, but in one published report, a spokeswoman said the company made the decision because it believes the majority of patients do not need propofol, which it considers a general anesthetic.
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| A New Candidate for Accreditation?
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The U.S. subsidiary of an international quality management and product-testing firm is aiming to join JCAHO, AAAASF and AAAHC in accrediting healthcare facilities for Medicare participation.
TÜV Healthcare Specialists, a Cincinnati-based division of TÜV America, has submitted its application to CMS, which the company says has begun its formal evaluation of the service. If approved, TÜVHS would be the first new accreditation agency for healthcare facilities in over 25 years.
In addition to surveying facilities for regulatory compliance and certifying them for Medicare compliance, TÜVHS plans to incorporate the International Standardization Organization's ISO 9001 management disciplines into its accreditation system.
"Healthcare providers are so inundated with compliance and regulatory obligations that they can't spare the resources to pursue quality as a separate 'project,'" says Rebecca Wise, CEO of TÜVHS, in a statement. "Quality management needs to be seamless and self-regulating. That is the advantage of ISO 9001 versus all other quality initiatives."
JCAHO, formed in 1951, has been accrediting facilities for Medicare compliance since 1965. It surveys the majority of U.S. healthcare facilities. AAAHC was founded in 1979 and AAAASF in 1980.
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| News and Notes
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HEALTHSOUTH CORP. HAS COUNTERSUED founder and former CEO Richard Scrushy, arguing that he had "pillaged" the company of more than $100 million during his tenure. The counterclaim is a response to Mr. Scrushy's wrongful termination and breach of contract lawsuit, filed Dec. 14, which seeks $70 million from the company. HealthSouth's suit did not specify the damages it was seeking, but claimed that Mr. Scrushy had received more than $100 million in salary, bonuses and stock sales due to inflated profit figures. Mr. Scrushy was acquitted of accounting fraud earlier this year.
THE AVERAGE PAYMENTS FOR OUTPATIENT SURGERY IN CALIFORNIA fell 38.9 percent in 2004 from 2001 following legislative reforms that capped workers' comp facility fees at 120 percent of the Medicare HOPD rate, according to a report from the California Workers' Compensation Institute, a private, nonprofit trade group.
THREE OPERATORS OF AN ORANGE COUNTY, CALIF., OUTPATIENT SURGERY CENTER pleaded guilty to charges they bilked insurers out of nearly $15 million by performing unnecessary surgeries on thousands of patients recruited nationwide, authorities said last week. Operators of the Unity Outpatient Surgery Center charged insurers $96 million and collected $15 million. One defendant, Tam Vu Pham, 41, of Fullerton, who operated the facility from June 2002 to October 2003, faces 13 years in prison. Two others received suspended prison sentences and were placed on five years' probation. Authorities say they expect to charge others in the scheme.
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