The U.S. Food and Drug Administration has prepared a document to help the thousands of Steris System 1 owners find a "legally-marketed substitute" for the sterilizer, the subject of a recent FDA safety alert and an ongoing squabble between the manufacturer and the agency.

The FDA says Steris has significantly modified the SS1 and notes that it has not approved or cleared this modified product. Steris has countered that the product is safe and effective when used as directed. About 23,000 System 1 units are in use worldwide.

The agency suggests that SS1 owners buy another reprocessor within the next 3 to 6 months. To help users navigate the field, it has compiled a list of FDA-cleared sterilization and disinfection products, which you can view on its Web site.

Alternatives to the SS1 have been grouped into the following categories:

The U.S. Senate's healthcare reform bill, which is headed for a final vote later this week, would restrict the growth and development of physician-owned hospitals, leading advocates of such facilities to step up their lobbying efforts on Capitol Hill.

Both the House and Senate versions of the bill contain language that would prohibit about 275 existing physician-owned hospitals from expanding, for example, by adding more beds or operating rooms, according to Physician Hospitals of America. "In four or five years, virtually none of these facilities will remain," says PHA lobbyist Randolph Fenninger, "because none can meet the criteria to be allowed to grow."

The bills would also restrict doctors from referring Medicare patients to hospitals in which they have a financial interest. Facilities that are certified as Medicare providers by Aug. 1, 2010, would be exempt from this rule in the Senate version of the bill, thanks to an amendment added over the weekend that extended the deadline from February. While the change would save a handful of hospitals, PHA Executive Director Molly Sandvig says more than 80 physician-owned facilities currently under development wouldn't be able to meet the new deadline.

If the Senate bill passes, legislators from both chambers will have to reconcile the House and Senate versions. Groups such as PHA and the newly formed Indiana Physician Hospital Association have an uphill battle as they try to make the case for saving physician-owned hospitals while hot-button topics like abortion coverage grab the headlines. "It's hard to be atop the list of priorities," says Ms. Sandvig. "We have to look at the most logical arguments to make now."

In its latest press release, PHA appeals to fiscal concerns, arguing that restricting physician-owned hospitals would not save Medicare any money, but would put "tens of thousands of people out of work" and harm local economies.

Irene Tsikitas

Ambulatory surgery centers, which have not received an annual update since 2004, will receive a 1.1% increase next year and, if the Medicare Payment Advisory Commission follows its staff's recommendation, a 0.6% increase in 2011. That's not nearly enough, says the Outpatient Ophthalmic Surgery Society and the American Society of Cataract and Refractive Surgery.

In a strongly worded statement to MedPAC, the groups urged the commissioners to recommend instead to Congress and CMS that ASCs receive the same increase, 2.7 percent, that has been projected for hospitals.

The 2 groups are lobbying MedPAC to use the Hospital Market Basket (HMB), which is used to update HOPD rates, to provide inflationary increases to ASCs rather than the Consumer Price Index (CPI-U), which is typically about a point lower, says Michael A. Romansky, JD, Washington counsel for OOSS. MedPAC staff has suggested that CMS collect cost data from ASCs to determine whether the HMB, the CPI-U, or the Medicare Economic Index (which is used to calculate physician practice costs) might be appropriate ASC update indicators or whether a new ASC-specific index should be developed to update ASC rates, says Mr. Romansky.

OOSS and ASCRS also object to MedPAC's recommendation that a cost reporting program be established for ASCs, noting that it would be unnecessary, wasteful, and administratively burdensome, since their rates are not based on ASC costs, but rather on a discount from HOPD rates.

The MedPAC Commission will consider its staff's suggestions next month and make recommendations on Medicare payment policy to Congress in the spring.

Dan O'Connor

The FDA has given surgical facilities 3 to 6 months to find a replacement for their Steris System 1 sterilizers. Have you selected an alternative product yet? Tell us in this week's InstaPoll. We'll report the results in this space next week.

Last week we asked if your anesthesia providers were pressuring you for an ultrasound machine to help them better place regional blocks. More than one-third (34%) of the 82 respondents said they already owned one. Another 29% said their anesthesia providers will probably get their wish for one. Thirty percent said they haven't been asked about ultrasound and 7% said they've been asked, but a purchase isn't likely.

Dan O'Connor