Washington Editor

The Centers for Medicare and Medicaid Services said Nov. 10 it will cover lung cancer screening with low-dose CT (LDCT) with several conditions, including a registry requirement and a maximum radiation dose set point. However, the agency continued the trend of imposing a facility experience requirement seen in other coverage decisions, including that for transcatheter aortic valve replacement.

CMS announced the coverage analysis in February, and said at the time that it would hold an advisory committee hearing to discuss the notion (Medical Device Daily, February 12, 2014), but the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) came back with some questions, including that of whether real-world usage would reflect the radiation dose-level restraint seen in the National Lung Screening Trial (NLST).

Congress also waded in via two communiqués to CMS urging the agency to expeditiously cover LDCT screening per the 2013 recommendations of the U. S. Public Services Task Force (MDD, June 6, 2014). CMS has held its ground on the timing of its review, however, indicating in the draft coverage proposal that it will stick to the projected final decision memo date of Feb. 8, 2015. The agency will accept comment on the coverage proposal through Dec. 10.

The proposed decision memo offers screening for those between the ages of 55 and 74 years, a window six years narrower than that recommended by USPSTF. CMS also indicated it may stipulate that the initial screening can only be ordered during a lung cancer screening counseling session, although subsequent screenings could be ordered during Medicare wellness visits. The criteria for radiologist experience include supervision and interpretation of at least 300 CT acquisitions in the prior three years, while the criteria for imaging centers include participation in lung cancer screening trials (not explicitly limited to NLST), although the agency is allowing the alternative of accreditation and training/experience in LDCT screening.

CMS also proposes to stipulate that facilities must demonstrate use of LDCT with a radiation dose of less than 1.5 millisieverts, but facilities must also forward data to a registry with information such as all-cause and cancer-related mortality, incidence of cancers, and diagnostic follow-up of abnormal findings within 12 months of a positive finding.

The American College of Radiology (ACR; Reston, Virginia) released a Nov. 10 statement in support of the coverage proposal, quoting Ella Kazerooni, chairwoman of the ACR lung cancer screening committee as saying, "CT lung cancer screening is the first and only cost-effective test proven to significantly reduce lung cancer deaths." Kazerooni also said screening "will help physicians save thousands of lives each year from the nation's leading cancer killer."

ACR indicated it will apply to be a Medicare-recognized registry, but noted also that lung cancer screening infrastructure "is growing quickly to meet the need for this important public health measure."

Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance (MITA; Washington), told MDD that MITA members see a few holes in the coverage proposal, but she also said CMS could have made it more onerous.

"Medicare is not stipulating in this decision what they mean by" certification, Rodriguez remarked, speculating that it may entail "training [and] maybe some sort of separate certification program. I hope it's not too burdensome," she said, adding, "these are not difficult scans to perform or read."

"I understand CMS wants the highest quality scans and interpretations. We'll have to see what a certification program will look like," Rodriguez commented. She said one option might be something akin to certifications assembled by FDA in response to the Mammography Quality Standards Act (MQSA), but she made the point, "these scans can be very interpretable at low doses," and some are conducted at energy levels lower than a millisievert.

"It's important to note that they did not require coverage with evidence development," Rodriguez continued, but she nonetheless maintained, "it's still fairly burdensome." She speculated, "these requirements are head nods to MedCAC and others who have expressed concerns."

"I believe they should have covered this outright per the USPSTF population," Rodriguez said, including the age-range provision. "I thought the evidence was so powerful. We've never had evidence this powerful in the imaging world," she said, and hence "there should not be conditions attached."

Rodriguez said the false positives conversation has ebbed, but is still out there. The rate of false positives, however, "trends down when you go form four millisieverts to one," she said, but she observed, "people are less worried about it than they were."

CMS did not address the question of reimbursement rates for LDCT, but an article at the website for Brown University (Providence, Rhode Island) states that the reimbursement for the NLST scans was $285. An article in the New England Journal of Medicine said that LDCT adds a cost of more than $1,600 per person screened compared to no screening, and that an additional quality-adjusted life year would incur costs in excess of $80,000.

One oft-cited QALY metric used to justify the deployment of a medical technology is $50,000 per QALY, although the legitimacy of that threshold has also been questioned.

NICE eyes Bard's Sherlock 3CG

The UK's National Institute of Health and Care Excellence (NICE) announced Nov. 10 it had opened a consultation for "a device that aims to make it easier to place a catheter correctly when it's inserted through a vein in the arm." NICE was referring to the Sherlock 3CG tip confirmation system by Bard Access Systems (Salt Lake City) for peripherally inserted central catheters (PICC).

NICE stated that the Sherlock system "uses magnetic and electrocardiographic (ECG) real-time tracking" of the catheter to ensure proper positioning, "thus avoiding the need for the patient to have an X-ray to confirm" catheter tip location. The agency noted further that the cost of using the Sherlock "is similar to blind insertion followed by X-ray, but it can save up to £106 per patient in specific clinical situations."

NICE indicated the public consultation period ends Dec. 9 and that it will render a decision Jan. 22, 2015.

No Comments