CMS has released three new draft LCDs for comment: Bowel Management Devices, External Infusion Pumps and Lower Limb prosthesis. The External Infusion and Lower Limb drafts are revisions to the existing LCD, while the Bowel Management Device draft is a newly proposed LCD.
In the Bowel Management Device LCD draft, CMS breaks down a number of products including bed pans, incontinence garments and disposable underpads to clarify the coverage status of these items. In this proposed draft, CMS allows coverage for bed pans (E0275 & E0276), but continues to classify incontinence garments, disposable underpads and miscellaneous incontinence supplies as non-covered services.
In the External Infusion Pump draft policy, the coverage criteria for the administration of parenteral inotropic therapy has been significantly altered to include additional documentation requirements and monitoring for medical necessity. We strongly encourage suppliers of External Infusion Pumps and related drugs to review these changes prior to the comment deadline. Suppliers can find the draft policy on their DME MAC website.
The proposed draft of revisions to the Lower Limb Prosthesis LCD contains the most significant changes as the policy was essentially overhauled with new coverage criteria, policy requirements, documentation requirements and definitions.
The policy begins by defining: initial prosthesis, replacement prosthesis, immediate prosthesis, preparatory prosthesis, definitive prosthesis, new amputation, revised amputation and mature residual limb. In the new draft, there are three general groups that these products will be categorized under: immediate (postoperative) prosthesis, preparatory prosthesis and definitive prosthesis. Each category is then broken down into its own coverage and coding requirements. Overall though, coverage for these products will be dependent upon a qualifying amputation, when the prosthesis is supplied in the healing process and the beneficiary’s motivation to ambulate using the product.
Another major shift proposed in this draft is the requirement for an independent medical exam by a Licensed or Certified Medical Professional (LCMP) to determine the beneficiary’s functional status. This section also breaks down the medical professionals that are considered a Licensed or Certified Medical Professional (LCMP). This additional documentation requirement alters the way that suppliers handle intake for these products.
Another new requirement in this draft requires new amputees to participate in a rehabilitation program prior to receiving a definitive prosthesis. In the rehab program the beneficiary must:
- Don and doff the prosthesis without assistance,
- Transfer without assistance both using and not using the prosthesis,
- Have sufficient wear tolerance to use the prosthesis for a normal day’s activities,
- Attain sufficient balance and stability to ambulate with ease of movement and energy efficiency with the preparatory prosthesis after final residual limb volume stabilization and prior to provision of the definitive prosthesis.
The prosthetist will be required to obtain information regarding the beneficiary’s participation in the rehab program which demonstrates the beneficiary is able to ambulate and manage the use of their preparatory prosthesis, and that that the residual limb is sufficiently mature and stable. This documentation must be on file in order to justify the provision of a definitive prosthesis.
The policy also revises the sections dedicated to the K –level functional modifiers with a dedicated section that describes each functional level. Repair and Replacement is also addressed in this revised policy to provide details on the approved scenarios for replacement and repair of these prosthetic devices.
Lastly, the draft contains new language in the Policy Specific Documentation Requirements section regarding the proper use of forms to facilitate record keeping. In this section it is states that CMS does not prohibit the use of templates, however, they also do not endorse or approve of any particular templates. The policy specifically “discourages” forms with check boxes, predefined answers or limited space for writing as these forms “often fail to capture sufficient detailed clinical information to demonstrate that all coverage and coding requirements are met”.
CMS will be accepting comments on the above draft policies through the close of business on Monday, August 31, 2015. Comments must be submitted electronically to DMAC_Draft_LCD_Comments@athem.com. The established contact for this process is Jurisdiction B Medical Director, Stacey V. Brennan, M.D, FAAFP.