Average timeframes for each step of CMS' national coverage processes in 2001 were significantly shorter than prospective targets established by the agency, according to a ¹ ¹ June HHS report to Congress.

From the date of decision memorandum issuance to implementation of instructions, the average national coverage determination (NCD) time was 156 days, compared with the 180-270 days forecast by CMS in 1999.

Although the agency explains that the targets are for "straightforward issues" and that "significantly more complex or controversial coverage issues may require [their] extension," CMS performed in line with its internally developed goals.

HHS acknowledges, however, that "although the average is 156 [days], six of the 10 decisions did exceed the target times." Excluding two emergency NCDs for coverage of liver transplants in non-approved centers during a hospital capacity crisis in Houston, average total time was 195 days, still falling within the low end of CMS' range.

The letter represents the first annual NCD report, now required under the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA). CMS did not meet its Dec. 1, 2001 deadline for the report (² ² Also see "Medicare Coverage, Appeals Process Reforms Pressed By Device Advocates" - Medtech Insight, 11 February, 2002., p. 7).

Additionally, the document suggests that Medicare Coverage Advisory Committee (MCAC) reviews are associated with an overall cut in the duration of coverage decisions issued by CMS for devices that undergo an independent technology assessment (TA).

For the three determinations that were subject to a 180-day TA timeline as well as the 180-day timeline for an MCAC recommendation, decision implementation times totaled 517, 426 and 356 days.

By contrast, for "intestinal and multivisceral transplantation," the only NCD subject to a technology assessment without MCAC, total time was 733 days (see chart: " ³ ³ Fiscal 2001 National Coverage Determinations* (Total Days From Date of Reques t)").

The average time for the three NCDs using MCAC - biofeedback for treatment of urinary incontinence, pelvic floor electrical stimulation for treatment of urinary incontinence and FDG positron emission tomography - was 433 days, 40% less than the non-MCAC decision.

The report additionally breaks down the time taken for implementing coverage, coding and payment determinations, including "critical steps" such as TA and referral to MCAC. Seven NCDs announced in 2001 were not included in the report because they did not become fully operational by Sept. 30, 2001.

CMS staffers indicate that the next annual report, which will include the seven "leftover" cases, should be released either in late 2002 or early 2003, much closer to the BIPA-mandated Dec. 1 deadline.

AdvaMed received the data critically. In a July 31 release, the association cautioned that "even after these decisions are made, it can take the agency an additional two years or more to set adequate payment rates for a new technology or service."

From the start to the finish of each national coverage process for the 10 decisions, excluding the two emergency cases, AdvaMed observed that the average NCD lasted 383 days.

The association points to legislative reforms passed by the House that would help reduce the delays by creating a council for technology and innovation to improve accountability in Medicare coverage and payment. Those provisions are contained in a prescription drug bill, HR 3391, which cleared the House in December (⁴ ⁴ Also see "Device Inpatient Payment, Medicare Contractor Reforms Pass With Drug Bill" - Medtech Insight, 24 June, 2002., p. 5).

CMS’ First Coverage Timeliness Report To Congress: NCDs Averaged 156 Days

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