Response to Public Comments for Emergency Notice

Comments on CMS‐10421 (OCN 0938‐1169): Emergency Federal Register Notice Regarding

Expansion of Prior Authorization of Power Mobility Devices (PMDs) Demonstration

The Centers for Medicare & Medicaid Services (CMS) received 4 complete responses with comments and 1 response that did not require a response from stakeholders related to CMS-10421. This is a summary of the comments.

1. Comment:

The PMD demonstration offers certainty for suppliers, beneficiaries and CMS alike. There is support to expand the demonstration.

Response:

The CMS concurs.

2. Comment:

There should be a clinical-medical template to standardize the collection of clinical criteria during the face-to-face encounter. This would ensure the effectiveness and limit the burden of the collection of information. CMS should develop a practical prior authorization form or template to aggregate all data necessary for prior authorization approval in one document. CMS should finalize an automated submission system.

Response:

CMS does not believe that a prior authorization request form is necessary for the expansion of this demonstration. As the information collection associated with this demonstration is not introducing any new Medicare documentation requirements, a form is not necessary. By collecting this information earlier in the process, suppliers should know before the PMD is delivered whether Medicare will pay for the device, assuming all other requirements are met.

CMS is pursuing development of an electronic clinical template that would allow Electronic Health Records vendors, in all 50 states, to assist physicians in thoroughly documenting the face-to-face encounter. CMS has developed a list of clinical elements within a Suggested Electronic Clinical Template that would allow electronic health record vendors to create prompts to assist physicians when documenting the Power Mobility Device (PMD) “face-to-face examination” for Medicare purposes. The current draft is available at http://www.coms.gov/Research-Statistics-Data-and-and-Systems/Computer-Data-and-Systems/ESMD/Downloads/Suggested-PMD-Electronic-Clinical-Template-v98-508posted-11-02-12-.pdf.

To bring the suggested clinical elements to the provider community, CMS is currently collaborating with the Office of the National Coordinator for Health IT (ONC) and the electronic Determination of Coverage (eDoC) workgroup in developing the interoperability standards necessary for an electronic clinical template.

All DME MACs accept prior authorization requests through CMS’ electronic collection system, Electronic Submission of Medical Documentation (esMD). To submit a prior authorization request through esMD, providers must choose a CMS-certified Health Information Handler (HIH) that offers prior authorization documentation submission services. More information on esMD is available at www.cms.gov/esmd.

3. Comment:

CMS must develop a comprehensive standard face-to-face examination medical necessity evaluation template/form for the physician and treating practitioners. CMS should develop this DME information form that captures and transmits essential objective data required for PMD coverage.

Response:

CMS does not believe that a face-to-face evaluation form is necessary for this demonstration. As the information collection associated with this demonstration is existing documentation requirements available at www.cms.gov/MCD. By collecting this information earlier in the process and for an increase number of PMDs, suppliers should know before the PMD is delivered whether Medicare will pay for the device assuming all other requirements are met.

CMS does not intend to create a required form due to the vast range of conditions that can create the need for a PMD. CMS does not believe that a template for documenting the existing face-to-face encounter is necessary to conduct this demonstration.

CMS is pursuing development of an electronic clinical template that would allow Electronic Health Records vendors, in all 50 states, to assist physicians in thoroughly documenting the face-to-face encounter CMS has developed a list of clinical elements within a Suggested Electronic Clinical Template that would allow electronic health record vendors to create prompts to assist physicians when documenting the Power Mobility Device (PMD) “face-to-face examination” for Medicare purposes. The current draft is available at http://www.coms.gov/Research-Statistics-Data-and-and-Systems/Computer-Data-and-Systems/ESMD/Downloads/Suggested-PMD-Electronic-Clinical-Template-v98-508posted-11-02-12-.pdf.

To bring the suggested clinical elements to the provider community, CMS is currently collaborating with the Office of the National Coordinator for Health IT (ONC) and the electronic Determination of Coverage (eDoC) workgroup in developing the interoperability standards necessary for an electronic clinical template.

4. Comment:

Further automation should be operationalized to enhance the information collection’s quality, utility and clarity. Suppliers are subject to additional burden placed on them by having to ensure that the ordering physician’s medical documentation meets medical necessity requirements. CMS has developed an electronic clinical template but it has not been launched yet.

Response:

Medical necessity has always been established by a practitioner and CMS has always required the supplier to ensure that the items/services it supplies are in fact medically necessary. It is important to keep in mind that this information collection is not introducing any new Medicare documentation requirements. By collecting this information earlier in the process and for an increased number of PMDs, suppliers should know before the PMD is delivered whether Medicare will pay for the device, assuming all other requirements are met.

As noted CMS is pursuing development of an electronic clinical template that would allow Electronic Health Records vendors, in all 50 states, to assist physicians in thoroughly documenting the face-to-face encounter CMS has developed a list of clinical elements within a Suggested Electronic Clinical Template that would allow electronic health record vendors to create prompts to assist physicians when documenting the Power Mobility Device (PMD) “face-to-face examination” for Medicare purposes. The current draft is available at http://www.coms.gov/Research-Statistics-Data-and-and-Systems/Computer-Data-and-Systems/ESMD/Downloads/Suggested-PMD-Electronic-Clinical-Template-v98-508posted-11-02-12-.pdf.

To bring the suggested clinical elements to the provider community, CMS is currently collaborating with the Office of the National Coordinator for Health IT (ONC) and the electronic Determination of Coverage (eDoC) workgroup in developing the interoperability standards necessary for an electronic clinical template. In the meantime the template can be used as a guide to assist physicians.

All DME MACs accept prior authorization requests through esMD. To submit a prior authorization request through esMD, providers must choose a CMS-certified Health Information Handler (HIH) that offers prior authorization documentation submission services.

5. Comment:

The CMS should develop an online process for prior authorization submittal and approval. The will provide a more efficient and timely process.

Response:
All DME MACs accept prior authorization requests through esMD. To submit a prior authorization request through esMD, providers must choose a CMS-certified Health Information Handler (HIH) that offers prior authorization documentation submission services.

6. Comment:

Stakeholders encourage CMS to implement a thorough education process for the new states. CMS must be committed to providing possible “submitters” with adequate guidance on how best to ensure the accuracy of the submission and avert denials for incomplete information. CMS should provide at least 90 days of advanced notice and education to the suppliers, clinical and beneficiaries in a state.

Response:

CMS agrees and looks forward to continued productive interactions with stakeholders. However, in regards to the information collection, this demonstration does not require any new documentation requirements. The demonstration allows for upfront collection of medical documentation for applicable PMDs ordered in the demonstration states.

CMS has worked closely with stakeholders in the outreach and education for the demonstration. CMS has been providing guidance on its website, go.cms.gov/PADemo about the demonstration, which is only collecting existing documentation. However, it is important to keep in mind that this information collection is not introducing any new Medicare documentation requirements. By collecting this information earlier in the process and on an increased number of PMDs, suppliers should know before the item is delivered whether they will receive payment assuming all other requirements are met. The documentation requirements are outlined in the longstanding local coverage determination (LCD). CMS has issued a series of educational materials to provide further clarification of the type of documentation that can be submitted to justify the need for a PMD. These education materials provided guidelines for the appropriate ordering and billing of PMDs.

Now that the expansion has been announced, we will soon begin education on the demonstration expansion. We plan on hosting Open Door Forum calls, placing information on our website, sending letters to suppliers and providers, etc. CMS will begin this demonstration no sooner then September 1, 2014.

7. Comment:

CMS must ensure proper staffing and training for MACs responsible for processing of prior authorization requests. The PRA requires CMS to plan and allocate resources for the efficient and effective management and use of the information to be collected.

Response:

CMS agrees that for a successful demonstration that limits unnecessary burden, there must be proper staffing and training for DME MACs responsible for processing of prior authorization requests. CMS will ensure that the DME MACs are properly staffed to meet all timeframes and that staff is trained to ensure consistent determinations. CMS will actively monitor the demonstration in order to manage workloads and ensure consistency.

8. Comment:

One commenter discussed a two phased approach.

Response:

The two phased approach was not a part of this package. To maximize the remaining time in the demonstration, CMS will be beginning all the 12 states at once. The discussion of a two phased approach was from a non-substantive change that was halted.

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