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Centers for Medicare & Medicaid Services

View Public Comments for CED Public Solicitation

Commenter:
Hammer, Dale
Title:
Senior Vice President Global Compliance
Organization:
DJO Global
Date:
01/17/2012
Comment:

January 17, 2012

Ms. Marilyn Tavenner, Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: CED Public Solicitation

Dear Ms. Tavenner:

DJO Global, Inc. (DJO) appreciates the opportunity to submit comments on the Centers for Medicare & Medicaid Services' (CMS) coverage with evidence development (CEO) policy.

DJO is a leading global developer, manufacturer, and distributor of high-quality medical devices that provide solutions for pain management, musculoskeletal health, and vascular health. Our products address the continuum of patient care, from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. With regard to medical technology, DJO is a leading designer, manufacturer, and distributor of orthopedic products and transcutaneous electrical nerve stimulation (TENS) products used for pain management.

DJO agrees with CMS that the goal of any CED policy should be "to accelerate Medicare beneficiaries' access to innovative items and services." We are concerned that as currently configured, CMS's CED policy is overly-cumbersome and can pose a barrier to coverage of effective technologies. CMS should ensure that any application of its CED policy does not hinder Medicare beneficiary access to safe, effective medical care. To that end, DJO recommends that:

  1. Coverage with Study Participation should be used as an alternative to noncoverage for situations in which: (1) there are either demonstrated safety concerns associated with a new technology or with new uses of an existing technology, or (2) when there is reliable evidence that a new FDA-approved technology is not reasonable and necessary for use in the Medicare population or a Medicare subpopulation.

  2. To the extent CMS seeks additional information about use of a technology, CMS should consider alternatives to the registry option provided under the Coverage with Appropriateness Determination mechanism. For instance, CMS could develop modifiers describing treatment parameters or other claims based reporting for additional data collection, or use beneficiary surveys to provide additional information to CMS and its contractors on how care is furnished.

These recommendations are discussed in greater detail below. We would also suggest that in light of potential changes to the CED policy, CMS should suspend new or pending coverage reviews under which CED is a stated coverage option (i.e., TENS for chronic low back pain) until the CED review process is completed.

I. CSP Option Should be Limited to New Technology with Safety Concerns

In the current CMS guidance on "National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Develqpment," CMS sets forth the option of using CEO to permit Medicare coverage under certain circumstances when evidence is not adequate for coverage as reasonable and necessary under Section 1862{a){1)(E) of the Social Security Act.1 CMS identifies two "arms· of CEO determinations: (1) Coverage with Study Participation (CSP), under which CMS will provide coverage only to patients enrolled in an approved clinical research study that meets certain rigorous standards; and (2) Coverage with Appropriateness Determination (CAD), under which additional clinical data must be submitted by the provider to a database or registry as a condition of the beneficiary's coverage.

We share CMS's view that it is valuable to have alternative mechanisms to expand Medicare beneficiary access to new medical technologies while clinical evidence is still emerging to demonstrate that a technology meets the statutory "reasonable and necessary" standard. We believe that situations justifying CSP as a condition of Medicare coverage would be very rare, however, since imposing new clinical trial requirements would effectively deny most beneficiaries access to an approved medical technology for many years.

CMS suggests that CSP could be used to "influence clinical practice and help Medicare beneficiaries and providers make the most appropriate diagnostic and therapeutic decisions." However, a general interest in additional Clinical information should be insufficient grounds to trigger a CSP coverage limitation. While additional evidence can help refine treatment practices for virtually any medical technology, there are very few circumstances that justify essentially revoking patient access to such technology while such additional evidence is gathered.

In particular, CSP should not serve as a barrier to widespread patient access to technology that has longstanding Medicare coverage and that is widely regarded by clinicians as a safe and effective treatment. For example, in opening up long-standing Medicare coverage policy for TENS for chronic low back pain, CMS requested comments on the applicability of "clinical studies falling under the Coverage with Evidence Development (CEO) paradigm." Clinical evidence clearly shows that TENS used for chronic low back pain meets the statutory criteria under § 1862{a)(1)(A), as there is ample evidence that TENS, when properly administered, is reasonable and necessary as an effective treatment for low back pain. It simply is unjustifiable to deny Medicare beneficiaries with chronic low back pain the documented, safe pain relief available through the proper use of TENS while any additional studies of this technology are conducted. Restricting access to this technology instead could necessitate greater use of potentially addictive narcotics and in some cases result in the need for surgical intervention.

We urge CMS to ensure that any application of its CEO policy does not hinder Medicare beneficiary access to safe, effective medical care, such as the use of TENS for chronic low back pain. Thus, we recommend that CMS limit the use of CSP as an alternative to noncoverage for situations in which: (1) there are demonstrated safety concerns associated with a new technology [or new uses of an existing technology], or (2) when there is reliable evidence that a new FDA-approved technology is not reasonable and necessary for use in the Medicare population or a Medicare subpopulation.

II. CMS Should Provide Alternative Data Collection Options Under CAD

To the extent CMS seeks additional data about use of a technology. CMS should consider alternatives to the registry option currently provided under the CAD mechanism. The establishment of a registry is a lengthy. cumbersome process. and reporting to registries is burdensome to impacted providers. This results in many providers electing to "opt-ouf' of the registry process. leading to the potential for a two tier Medicare system: only the Medicare patients whose providers agree to participate in the process will be eligible to receive the benefit. Instead. to the extent that CMS requires additional information for Medicare coverage purposes. CMS should explore the use of claims modifiers or other claims-based reporting options that can provide additional details on the specific patient characteristic or treatment parameter of interest to CMS. Alternatively. CMS could consider whether beneficiary follow-up surveys would provide the requisite information. This information would be reported directly to CMS or its contractors. bypassing the need for a third party to collect. aggregate. and submit the data to CMS for further review. CMS also should set forth clear parameters for ending the collection. assessing the collected data. and applying the data to Medicare coverage policy.

More broadly, CMS should ensure that any data collection requirement seeks to furnish very specific information that is necessary to determine a specific Medicare coverage policy issue. It is not appropriate to impose such requirements on providers and other stakeholders simply to further general research goals.

*****

We appreciate your consideration of our comments. We would be pleased to answer any questions you may have or to provide additional information.

Sincerely,

Dale Hammer
Senior Vice President
Global Compliance & Government Relations

cc: Dr. Louis Jacque, Director, CAG
1. Section 1862(a)(1 )(A) provides that: (a) Notwithstanding any other provision of this title, no payment may be made under part A or part 8 for any expenses incurred for items or services( 1 )(A) which, except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member
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