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| Medtronic Spine Settles Device Lawsuit |
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Medtronic Spine has agreed to pay Medicare $75 million to settle a whistleblower lawsuit that claimed that it encouraged physicians to perform the kyphoplasty procedures it supplied components for in hospital inpatient settings, a more costly alternative than clinically appropriate outpatient settings.
According to the U.S. Department of Justice, the Sunnyvale, Calif.-based division, formerly known as Kyphon and acquired by Medtronic last year, created an "aggressive marketing scheme" that promoted its minimally invasive spine products for treating compression fractures as devices for inpatient surgery. The government also alleges that Kyphon paid physicians and hospitals to use its KyphX instruments and bone fillers for Medicare patients in inpatient procedures. As a result, Medicare reimbursed providers and institutions for more expensive procedures over the past seven years.
Medtronic Spine also entered into an agreement with the Department of Health and Human Services to ensure that the company complies with Medicare regulations in the future. The two former Kyphon employees who filed the whistleblower suit in 2005 will share $14.9 million of the settlement amount.
"There's no surprises associated with this resolution," a Medtronic spokeswoman commented in a published report. The Minneapolis-based manufacturer was aware of the lawsuit and the planned settlement, in which it and Kyphon admitted no wrongdoing, before purchasing Kyphon for $3.9 billion.
Kent Steinriede |
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| Survey Shows Surge in ASC Case Volume |
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The preliminary results of a government survey reveal a nearly 70 percent increase in patient visits to outpatient surgery facilities (including ASCs and hospitals) between 1996 and 2006, with the industry's growth concentrated primarily at freestanding ASCs.
Karen Cullen of the National Center for Health Statistics unveiled the early findings of her center's 2006 National Survey of Ambulatory Surgery at the ASC Association's annual meeting in San Antonio this month. The survey is the first of its kind in a decade. Ms. Cullen told ASCA attendees that the results would help them make side-by-side comparisons between their facilities and hospital-based outpatient surgery departments.
The survey's findings, which Ms. Cullen says are subject to change before final results are publicly released this summer, show the number of patient visits to freestanding ASCs rising more than 300 percent between 1996 and 2006. In comparison, hospital-based facilities saw an increase of about 14 percent during the same time. Although a slim majority of outpatient procedures are still performed in hospital settings, the surge in patient visits has allowed freestanding facilities to obtain a much larger portion than they had in 1996.
The survey shows that colonoscopies are currently the most common procedures performed on an outpatient basis. In 1996, cataract removal topped the list.
The National Center for Health Statistics plans to post the survey's final results, including data on patient characteristics and surgical outcomes, on its Web site in August.
Irene Tsikitas |
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| Urology and Gynecology Procedures Moving to ASCs |
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While more than 80 percent of gynecological surgeries and 70 percent of urological surgeries are performed in hospitals, some procedures are becoming more popular in ASCs and office-based facilities, according to a survey by the Millennium Research Group. The worldwide medical information firm suggests this change may result from the recent changes to Medicare's reimbursement structure.
"The reimbursement shift may encourage physician and patient adoption of in-office gynecology or urology procedures, expanding the number of facilities that perform them," says Nadia Lachowsky, an analyst for MRG. "We're planning to run another survey to measure this, but right now it's mainly expectations."
Some of the codes that are more profitable in ASCs, now and following 2011's fully transitioned rates, are:
| Procedure | 2007 rate | 2008 rate | 2011 rate |
| 52612 (Prostatectomy, first stage) | $446 | $701.91 | $1,493.64 |
| 52614 (Prostatectomy, second stage) | $333 | $623.16 | $1,493.64 |
| 52647 (Laser coagulation of prostate) | $1,339 | $1,472.13 | $1,871.50 |
| 52648 (Laser vaporization of prostate) | $1,339 | $1,472.13 | $1,871.50 |
| 53850 (Prostatic microwave thermotex) | n/a | $1,871.50 | $1,871.50 |
| 53852 (Prostatic radio frequency thermotex) | n/a | $1,871.50 | $1,871.50 |
| 53853 (Prostatic water thermotherapy) | n/a | $1,025.71 | $1,025.71 |
| 58353 (Endometrial ablation, thermal, without hysteroscopic guidance) | $995.00 | $1,018.84 | $1,342.37 |
| 58356 (Endometrial cryoablation) | n/a | $1,768.23 | $1,768.23 |
| 58563 (Hysteroscopy with endometrial ablation) | $1,339.00 | $1,358.28 | $1,416.11 |
Nathan Hall |
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| News & Notes |
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Florida CON law streamlined General hospitals in Florida may find it easier to gain approval for new construction projects thanks to Gov. Charlie Crist's signing of SB 2326 into law last week. Challengers to proposed hospital construction are now required to submit a detailed record of their concerns to the state during the certificate of need review process. Also, parties who appeal the state's final approval of construction must post a $1 million bond and cover the opposition's legal expenses if the appeal is lost. The law streamlines CON approval, taking the "high cost of litigation out of the process," says bill sponsor Sen. Durell Peaden.
Medicare expanding bariatric coverage? CMS is seeking public comment until June 18 on the benefit outcomes of bariatric surgery as a treatment for diabetes. Medicare currently has national coverage for bariatric surgery but not specifically for the condition's treatment. In February 2009, the agency will release a national coverage analysis of the scientific evidence claiming that bariatric surgery can cure diabetes.
Joint Commission offering electronic manuals The Joint Commission's 2009 program manuals will be available as electronic "E-ditions" to the agency's customers beginning in November. In addition to the customary free print copy of the comprehensive manual, organizations will receive a free, single-user-license E-dition that can be upgraded to a site license for a fee. The electronic manual will be accessible via the Internet with a login name and password. The E-dition will offer easy navigation to standards and historical crosswalks, keyword search capability and links between 2008 and 2009 standards. |
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