Director of Health Policy and Regulatory Affairs
Society of Nuclear Medicine
Louis Jacques, M.D.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mail Stop C1-12-28
7500 Security Boulevard
Baltimore, MD 21244
VIA ELECTRONIC SUBMISSION
RE: Coverage with Evidence Development; Request for Comments
Dear Dr. Jacques:
The Society of Nuclear Medicine (SNM) appreciates the opportunity to respond to the request for comments on the potential to improve Coverage with Evidence Development (CED). SNM’s more than 17,000 members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals, meetings, and leading advocacy on key issues that affect molecular imaging and therapy research and practice. SNM endorses the National Oncologic PET Registry (NOPR), which embodies an innovative approach to CED. The SNM has actively participated in the CED process through its work for NOPR, providing education and billing assistance to our participating members.
SNM applauds the Centers for Medicare & Medicaid Services (CMS) for implementing CED as an alternative for new technology or indications for which it would be hard to conduct large scale studies. We believe that NOPR, as a CED program, was a significant step in the right direction for CMS coverage policy. However, CED is not without problems and SNM agrees with CMS that there is room for improvement. In its present format, CED remains cumbersome from implementation to final coverage decisions. Additionally, delays and misinterpretations by CMS Medicare administrative contractors (MACs) have presented implementation issues. Examples include claims denials for clearly covered indications (details outlined later in this letter), missed data entry deadlines by participants, and billing confusion due to complicated indication-by-indication coverage policy, including requirements for multiple coding modifiers, leading to a need for major educational assistance with hundreds of volunteer manpower hours utilized.
CED Reform with Emphasis on Shorter Timelines
We believe the primary current deficiency of CED is the length of time CMS requires to move through the NCD process and issue a final coverage decision. The first step in the current process is to open a National Coverage Decision (NCD) or a reconsideration of an existing NCD, prior to allowing a CED project to move forward. This lengthy process requires multiple comment and review periods, extending over a period, at a minimum, of 90 days. In actuality, the process and timeframes have been taking, on average, one year or more from concept to implementation. This reflects the time needed by CMS CAG staff to post decisions, review comments, and prepare drafts and final decisions and then for contractors to accurately implement the NCD policies to appropriately pay claims. The real-time processing of these steps collectively has resulted in a protracted time frame lasting one year or more from the time CMS officially opens the public opportunity for CED to actually getting a paid claim. CMS should consider reforms, including simplifying and streamlining the CED requirements and timelines, that will result in less time between initiation and payment.
Alternatively, CMS could consider varying CED paths, such as a fast track option, or a limited scope option. NOPR for FDG-PET and NOPR for NaF-PET each took over one year from CED approval by CMS to implementation of an approved CMS CED study. We believe the large scope and requirement to include all PET providers contributed to the long lead time. There may be opportunity to shorten this step in the process. Although the NaF registry is relatively recent, the FDG-PET registry is now six years in operation; this final step in the CED process must change in future design of registries as six years is not practical for new technology decisions. We support alternatives that would abbreviate this process with limited open comment periods to a more reasonable timeframe, e.g., exclusive of enrollment, decisions to open or close a CED should take no more than three months.
CMS should provide CED under a new revised model, in which a product or procedure could be covered if there is some type of ongoing post-FDA approval data collection for a predefined period of time. This period of time should be explicitly specified and not allowed to remain open-ended. This “fast-track” process to broader coverage would provide conditional coverage while evidentiary data are being collected:
I. For all radiopharmaceuticals, coverage should be immediate for FDA-approved indications.
II. Under this new model, a product would be covered for non-approved indications if there is data collection for an agreed upon period of time. After those data are published and reviewed, the CED program would be reevaluated, and if the evidence were not favorable, coverage could be limited.
III. CMS should accept a model of CED capable of being generalized beyond the patients in the registry or trial. It is impossible to conduct trials for each individual indication in order to secure CMS coverage of a procedure.
Professional societies and the medical community at large will work, via scientific publications and practice guidelines, to discourage utilization of medical procedures for those indications that are not appropriate.
Therefore, the SNM encourages CMS to streamline its ability to initiate and terminate CED without the need for lengthy NCD processes on either end of the process. CED provisions should be revised to authorize a faster initiation by CMS and requestors. Furthermore, because of problems with local contractors (MACs) in implementation, reflecting the complexity of indications and modifiers required by the CMS national decision, SNM suggests that CMS consider whether there may be options for use of CED on a limited scope pilot or targeted level.
CMS should capitalize on the positive attributes of local coverage, which include the ability to make decisions more quickly and reverse decisions when misunderstandings occur. The CMS national process currently has no mechanism for allowing regulatory discretion, which is what we expect for new technologies.
SNM agrees with previous observations from the NOPR Working Group that a balance needs to be found between data quality and data quantity. The advantages that can be obtained by ensuring high-level quality controls outweigh any advantages gained by collecting a higher volume of low-quality data.
Billing should be Simplified or Standardized on a National Level for Implementation by MACs
As we experienced with NOPR, actual operationalization with the MACs was not uniform or consistent with the intent of the NCD, often requiring many medical society interventions on behalf of the NOPR participants as well as interventions by CMS CAG staff for clarifications. Most MAC system edits required at least three months consisting of internal discussions and reprogramming of computer edits, leading to disruptive cash flow issues for many participants of the NOPR for claims processing and ultimately claims being paid for the services rendered.
The most recent example is the nonpayment of clearly covered claims for initial staging of prostate cancer with NaF bone PET by the following MACs: First Coast Service Options, Palmetto GBA and Highmark, all of which denied claims because of lack of contractor awareness of the new registry and the need to re-program their systems after becoming aware of the issue. Additionally, providers were not only denied for the initial submission, repeated claim appeals were also denied, causing excessive delays in payments of up to 8 months, a timeframe unacceptable by any standards. Streamlining the implementation of any new CED program at the MAC level is essential to improvement.
In summary, the SNM encourages CMS to streamline its ability to initiate and terminate CED without the need for lengthy NCD processes on either end of the process. CMS should revise CED provisions to authorize a faster initiation and conclusion of CED by CMS and requestors. Furthermore, CMS should capitalize on the local coverage positive attributes, which include the abilities to make decisions more quickly and reverse decisions when misunderstandings occur.
SNM appreciates the opportunity to provide comment on improvements to the Coverage with Evidence Development mechanism. Should you have any questions, please contact Sue Bunning, Director of Health Policy and Regulatory Affairs, via email firstname.lastname@example.org or telephone (703) 326-1182.
George Segall, MD