Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services continues its transformation of how it pays ambulatory surgical centers (ASCs) and hospitals for outpatient services (Medical Device Daily, June 20, 2007), but each iteration of the four-year project nonetheless manages to raise a fresh round of objections.

In this instance, operators of ASCs are feeling the pinch. Whether Congress will intervene is the open question, but the short time remaining in the current legislative cycle suggests the answer is no.

The July 3 announcement says that the proposed rule "includes a 3.0% annual inflation update to Medicare payment rates" for most services offered by the more than 4,000 hospitals and community mental health centers for calendar year (CY) 2009. On the other hand, two thirds of that 3% update may disappear for hospitals "that do not meet quality reporting requirements."

The agency states that it is "proposing to add four imaging efficiency measures that would be calculated" to the existing seven. CMS also seeks input on another 18 measures for hospital outpatient care, including cancer care and community-acquired pneumonia. The agency is also interested in a data validation system that would pluck 50 records from each of 800 hospitals to "validate the accuracy of reported data."

However, the reduced payment for failure to report the quality data would not apply to pass-through payments for some drugs and devices, to services assigned to new technology ambulatory payment classifications (APCs), or to separately payable radiopharmaceuticals. The overall expenditure under the outpatient prospective payment system to hospitals is projected to rise 9.4%, from $26.9 billion in CY 2008 to $28.7 billion.

CMS says that it intends to expand the number of procedures it will pay ASCs to perform and payment for device-related procedures will be the same as hospital outpatient departments when the use of the device is at least 50% of the total cost. New services that are "predominantly performed in physicians' offices" are capped at the amount paid to doctors providing those services under the Part B physician fee schedule.

The agency also proposes to pay for many imaging services under a composite APC in the case of multiple services provided in a single session. The services that would be subject to the composite payment rubric include magnetic resonance imaging and angiography, both with and without contrast agents, as well as computed tomography imaging and angiography, again both with and without contrasts. CMS intends to accept comments on the proposal until Sept. 2 and will ink a final rule by Nov. 1.

Kathy Bryant, President of the Ambulatory Surgical Center Association (ASCA; Alexandria, Virginia), told Medical Device Daily "most of this rule is actually implementing changes they had already adopted, so it's really just the next step in the transition." However, she said that the association's members "think that a payment more comparable to hospitals would be appropriate," and that the payments to ASCs for some services would drop to 59% of the payment made to hospital outpatient clinics.

"To expect us to be able to provide the same services [at such reduced rates] is a little hard to understand," Bryant said. Bryant also said that ASCA sees "no policy argument for not having an inflation update in both settings."

Bryant said "we do have some advocates on [Capitol] Hill, particularly on the payment update," but noted that "the time is very limited this year." She also said "this is an issue for us for years to come. If we can't do anything this year, we'll try again next year."

Assay could improve cancer prediction

Isolating a gene that is implicated in the occurrence of cancer is one thing. Figuring out which changes to that gene that actually correlate to cancers is another. A recent statement at the web site for the National Institutes of Health indicates that a test described as a functional assay may one day help physicians tell their patients whether they are susceptible to breast cancer and other cancers by the type of mutation.

According to the statement, introducing human BRCA2 genes into the nuclei of mouse allows researchers to tell whether the BRCA2 gene is intact because the intact genes "can compensate for the mouse Brca2 deficiency" in the cells isolated for the experiment. Faulty human genes do not compensate for this deficiency, and the mouse cells die off.

Shyam Sharan, PhD, of the National Cancer Institute, the lead author of the study, said that functional assays may also clarify which mutations are of concern and which are inconsequential. She said there are those who have "an unclassified [minor or previously unknown] change in these genes, and they do not know what it means. There is reason to believe that a significant number of women fall into this category, and our assay is likely to improve our understanding of unclassified mutations because it allows for analysis of all types of BRCA2 mutations."

The results of the study appear in the online edition of Nature Journal.