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Centers for Medicare & Medicaid Services

View Public Comments for CED Public Solicitation

Abraham, Brian
Dir. Coding and Reimbursement
IBA Molecular, NA

January 20, 2012

Louis Jacques, MD
Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Dear Dr. Jacques:

IBA Molecular Tracers, a division of Ion Beam Applications, SA, (IBA) develops and markets leading-edge technologies, pharmaceuticals and tailor-made solutions for healthcare with a focus on cancer diagnosis and therapy. IBA is interested in commenting on Coverage with Evidence Development (CED) because we manufacture molecular tracers used in Positron Emission Tomography (PET) scans, and have products in late-stage development that provide opportunities for physicians to better diagnose and treat patients, including Medicare beneficiaries. We are pleased that the Centers for Medicare and Medicaid Services (CMS) has solicited public comments on this issue. We also are supportive of CMS’s intended outcome of reducing barriers to innovation while enabling the agency to make better informed decisions that would improve health outcomes for Medicare beneficiaries.

We will comment on the three areas of interest described in the public solicitation:

  • Implementation of CED through the national coverage determination (NCD) or other avenues under Part A and Part B
  • Potential impact of CED on the Medicare program and its beneficiaries
  • Suggested approach to CED to maximize benefit to Medicare beneficiaries

CED through NCDs and Parts A and B

IBA firmly believes that Medicare beneficiaries should have access to medical technologies when these items receive approval by the US Food and Drug Administration (FDA) to enter the marketplace. We also understand CMS may need to evaluate whether some limitations on Medicare’s coverage of such items is warranted because of a variety of factors, including for example, utilization in an area that was not expected by either the manufacturer or the medical community, or utilization in circumstances where an existing product (perhaps, but not necessarily at a lower cost) fills a medical need equally or better than the new technology (as proven in the accepted scientific literature). Regardless of these reasons to limit coverage (or at least monitor utilization) of new technologies, we do not support the position that a new product having market approval by the FDA should have an automatic non-coverage decision through the National Coverage Determination (NCD) or other process under Parts A and B. We believe that any new technology ought to receive the same opportunity to prove itself in the market, demonstrate benefit to Medicare patients, and be free of market barriers (other than for safety or effectiveness reasons).

Thus, while IBA appreciates the CED process, as that is the only way our products (radiolabeled isotopes used in PET scans) have received coverage historically, we think that for any new products that emerge onto the market, coverage should be immediate and enduring, similar to other drugs approved by the FDA. If there are conditions that CMS wishes to place on the coverage, such as a time limitation in which to demonstrate that physician decision making has been affected by use of a product, for example, then individual manufacturers should have the ability to discuss with CMS how to assure enduring coverage for these products so they will continue to remain available to Medicare beneficiaries.

Impact of CED on Medicare Beneficiaries

Under the current CED rubric, automatic non-coverage through the NCD process of a particular product or service seems to send a signal to the public that CMS is not interested in covering this type of technology, no matter the innovations or improvements to come. Thus, Medicare beneficiaries do not have the opportunity to realize downstream benefits of such services, simply because manufacturers will not take the risk to develop the technology. Fortunately, for PET, there are new tracers being developed, but manufacturers are wary of the uphill struggle that will ensue in obtaining coverage if the CED process is not reformed significantly.

Administrative burden
The current CED process has proven to be administratively burdensome for all interested stakeholders, including CMS, Health Care Practitioners (HCPs), and Medicare beneficiaries. On several occasions, including the July 28-30, 2011, PET Coverage Workshop in which CMS officials participated, representatives from CMS stated that the system as it now stands is burdensome to administer and the agency is seeking ways to simplify the process without diminishing the rigor of evaluating coverage. Manufacturers of the products subject to CED also have found the process to be burdensome because these products are required to meet different standards to become covered than other products in the marketplace. HCPs have found the process to be burdensome because of the additional paperwork that must be completed to obtain payment under the CED process.

Patients have found the process particularly burdensome because of two primary reasons. First, there are some HCPs that will not complete the administrative procedures to obtain payment for an item subject to CED, so they simply will not offer it to patients, thus restricting Medicare beneficiary access to such a service or product. Second, some patients have inadvertently received bills for items and services covered under CED because the Medicare contractors’ systems have not been properly programmed. Thus, the HCPs either erroneously bill the patient or must conduct exhaustive research to resolve the issue. Either way, the Medicare beneficiary is involved administratively in a way that was unintended. Therefore, throughout the entire patient care continuum (and supply chain), the CED process has become overly burdensome to all parties involved.

Market fears that a product is not effective or safe
While the whole concept of CED has been to provide a way for Medicare to build additional evidence to cover and pay for items CMS initially perceived as not meeting a threshold for reasonable or necessary, and was likely meant as a path to reduce resistance, it has had a different effect on the market. There has been confusion in the marketplace even when the FDA has approved a product for safe and effective use in the market. In such circumstances, CMS has said it needs to consider additional evidence (that currently may not exist). HCPs, patients, and others may interpret this to mean that a product is not safe or effective and should not be used. If CED is to succeed, the messaging around the process must emphasize that it is the path clearing the way for payment, and that there is nothing intrinsically ineffective or unsafe about the product.

Suggested Approach to CED

In stating that we think a product should have endurance in the market, we still support the concept that CMS may have a reason for initiating a CED process. The reason for the CED action might be to validate physician decision making or other behavior as a result of using a diagnostic tool, or to measure health outcomes of Medicare beneficiaries who are prescribed a certain therapeutic product or service. Regardless of the situation triggering the CED action, we strongly encourage CMS not to delegate the CED activities to local Medicare contractors unless there is a single contractor responsible for a national CED initiative. This could lead to further confusion and worse, conflicting opinion and direction. We think that keeping the process simple and straight forward requires one, singular body overseeing a CED process; multiple entities handling CED would dilute the power of a CED requirement, as well as cause confusion from locality to locality. We also strongly encourage CMS to provide specific guidance and criteria, including what the agency considers reasonable and necessary to fulfill or clarify the CED issue at hand.

Along those lines, IBA supports the concept put forth by the Medical Imaging and Technology Alliance (MITA) in its comment to this solicitation that says that any item should have coverage upon market approval. Further, CMS still would have the authority to restrict coverage of a product after some time on the market if there was a reason that Medicare patients would not benefit from that technology.

We believe the best way to ensure that new technologies are used appropriately and that Medicare patients receive the maximum benefit from these technologies is to have the item available upon approval by the FDA. To ensure appropriate use, it is incumbent on CMS to declare for HCPs, manufacturers, and Medicare beneficiaries, what is reasonable and necessary for that technology. That way, if a manufacturer does not meet that threshold with the evidence utilized to attain FDA approval, then the manufacturer can discuss with CMS how to build the body of evidence necessary through the CED process. CMS has already made great strides in the area of PET imaging by stating that outcomes for beneficiaries should be improved by use of the product, and that physicians’ decision making would be impacted by the technology.

IBA appreciates CMS’s willingness to address this difficult issue by asking for public input on the process. We look forward to working with you towards a new approach for CED which will help Medicare beneficiaries take advantage of new technologies with minimal resistance. We are available to discuss this matter with you at your convenience. Please contact me at 571-237- 4437 or with any questions you may have.


Brian C. Abraham, MPA
Director or Coding and Reimbursement