Washington Editor

The Centers for Medicare & Medicaid Services reported last week that it will cover lung cancer screening via low-dose CT (LDCT) in a coverage decision that largely mirrors the agency's 2014 coverage proposal. One difference between the coverage proposal and the actual coverage is that eligible radiologists will be required to practice at an imaging facility that is itself eligible, a stipulation not seen in the proposal. However, CMS also doubled the permissible radiation dose to be used to perform the screening, although the agency makes use of a different measurement scale in the final coverage memo.

The LDCT/lung cancer screening discussion absorbed a substantial amount of bandwidth in Washington as CMS worked its way through the details. The agency convened a hearing of the Medicare Evidence and Coverage Development Advisory Committee to review the evidence, but both the Senate and the House of Representatives weighed in with letters last year urging CMS to cover the procedure without delay.

One feature of both the draft and final coverage proposals was that CMS would allow radiologists to be certified by entities other than the American Board of Radiology (Tucson, Arizona). The draft stipulated that the CT equipment used be limited to an effective radiation dose of less than 1.5 milliseiverts, whereas the final coverage document provides more detail. CMS will require that the imaging take place with a volumetric CT dose index of less than or equal to 3.0 milligray for "standard size patients," and "appropriate reductions" in dose for smaller patients along with appropriate dose increases in larger patients.

The final coverage document retains for the most part the beneficiary eligibility criteria of the draft, although the proposal referred to beneficiaries between the ages of 55 and 74 whereas the final uses the age of 77 as the maximum age of eligibility. The final coverage memo includes several additional stipulations regarding the use of reporting registries, including an explicit requirement for formation of a steering committee and governance board for registry oversight, language not found in the November 2014 draft. CMS added that a registry will have to develop "mechanisms to collect information... in order to permit linkage of registry data with external databases."

In a statement, Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance (MITA; Washington), characterized the outcome as "a triumph for Medicare beneficiaries who are at high risk for lung cancer and will now have access to life-saving scans." Rodriguez added, "given the high bar CMS holds in making national coverage determinations, it is clear that the benefits of LDCT scans for those at high risk of lung cancer are indisputable."

CMS eyes cognitive outcomes

The well-known association between cardiovascular procedures and purported declines in cognitive function has prompted an evaluation of this association by the Agency for Healthcare Research and Quality (AHRQ). CMS posted the AHRQ technology assessment at its website Feb. 2 (the review itself is dated Nov. 17, 2014), but the net effect of the report may be negligible.

The review examines intermediate-and long-term cognitive outcomes following four procedures, including coronary and carotid artery revascularization, and cardiac valve procedures. Also included in the review is ablation for atrial fibrillation "in older adults," and the review attempted to discern the evidence behind any association between these procedures and procedure-related stroke, transient ischemic attack (TIA), and "other procedure and patient characteristics."

The sorting process left the reviewers with 17 randomized, controlled trials (RCTs) and four prospective cohort studies, with an aggregate enrollment that was predominantly male (80%) and aged 68 years on average. Five of the 21 studies had excluded would-be enrollees "for some measure of abnormal baseline cognition," but the authors noted that more than half of the studies have reported mean baseline scores suggestive of impairment "for at least one neuropsychological test," the majority of which indicated impaired response times.

The data behind post-procedure cognitive function comparing on-pump and off-pump coronary artery bypass was deemed to be of low strength of evidence, but those data indicated no significant difference in cognitive outcomes. The report adds that the data indicated no difference in post-procedure cognitive function for hypothermic vs. normothermic bypass as well, although the three trials measuring this were deemed to offer low to moderate strength of evidence. Only one trial checked cognitive function for bypass versus medical management, but the lack of difference in cognitive outcome was undercut by an insufficient strength of evidence.

On the subject of carotid artery revascularization, the two available trials disclosed no difference in cognitive measures, although the data offered low to insufficient strength of evidence. The report mentions only one trial comparing surgical and transcatheter aortic valve replacement and their effects on cognitive function, and three-months measures indicated a 28% functional decrease in the transcatheter arm versus a 6% decrease in the surgical arm. The authors caution, however that these results "may have been limited by large selection and outcomes measurement biases," adding that the paucity of strokes and TIAs reported in the data prohibited any determination as to whether such events affected post-procedure cognitive outcomes.

OIG eyes Deaconess Medicare claims

Even the nation's elite hospitals aren't immune to the kind of microscopy that only a government agency can make use of, and the Office of Inspector General at the Department of Health and Human Services reviewed the books at Beth Israel Deaconess (Boston), isolating a few problems. The review of the hospital's claims that included medical device replacements led to the OIG conclusion that Deaconess owed the federal government in excess of $400,000, a conclusion with which the hospital's administrators apparently agreed.

The audit covered a bit more than $700,000 in Medicare payments for 23 claims (14 inpatient and 9 outpatient) for replaced medical devices, OIG said, which were dated between calendar years 2010 through 2013 inclusive. Three of those claims were clean, and 11 of the remaining 20 were inpatient claims that resulted in nearly $340,000 in erroneous billings, while all nine of the outpatient claims were problematic, netting the hospital roughly $144,000 in overpayment.

According to OIG, the tripwires included "inadequate education on inpatient level-of-care criteria," and Deaconess said it would resubmit the claims and re-train its staff.

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