Local Coverage Article Response to Comments

Response to Comments: Urological Supplies (DL33803)


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Article ID
Article Title
Response to Comments: Urological Supplies (DL33803)
Article Type
Response to Comments
Original Effective Date
Retirement Date
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Article Text

During the 45-day comment period the DME MACs received a total of seven comments: five comments were received from treating practitioners, one comment from a supplier, and one comment from a supplier association.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period on this proposed Urological Supplies Local Coverage Determination (LCD).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13, the final policy and our response to comments are based on general acceptance by the medical community, as evidenced by published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Response To Comments


One commenter submitted a request for additional clarifying language about when new orders are required in the Urological Supplies Policy Article (PA).

The comment is outside of the scope of this LCD reconsideration. Details regarding orders may be found in the Standard Documentation Requirements PA (A55426).


Four commenters submitted comments which endorsed coverage of the inFlow™ device. One commenter endorsed coverage of the inFlow device as an alternative to intermittent catheterization to improve quality of life, safety and dignity of women with PUR.

The final LCD has been published as it was proposed.


Several commenters suggested that inFlow coverage should include patients using indwelling, or suprapubic catheters.

The final LCD is based on the best currently available clinical literature, however the available evidence on patients using indwelling and suprapubic catheters is of lower quality. The commenters did not provide any additional clinical evidence to support their suggestion.


Several commenters requested that Medicare coverage extend to all women who have PUR, with broader language related to cause or based on having symptoms of PUR.

The commenters did not provide any clinical literature to support their suggestion. The final LCD is based on the best currently available literature.


One commenter requested that information in a retired DME MAC article regarding utilization of intermittent urinary catheters be included in the updated LCD.

The comment is outside the scope of this LCD reconsideration.


One practitioner commented that the policy should be revised to allow for more than one inFlow device every 29 days to allow for situations where the beneficiary must remove the device, such as for an MRI.

The inFlow Instructions for Use indicate replacement every 29 days. In the event of a situation where the beneficiary must remove the device prior to the routine replacement date, such claims may be considered upon appeal.


One commenter noted that the documentation requirements for continued coverage after 90-days were unclear.

As noted in the LCD, the purpose of the 90-day evaluation is to establish that the beneficiary’s urinary symptoms have improved, and the beneficiary is adherent to the usage of the inFlow device. The LCD language is deliberately not proscriptive on how a treating practitioner documents these two elements.


Two commenters raised concern about being unable to properly code for PUR due to IDC as no ICD-10 exists.

There are no specific ICD-10 codes applicable to the inFlow device. Since ICD-10 codes are not contained in the LCD, these comments are outside the scope of this LCD reconsideration.

Associated Documents

Related Local Coverage Documents
L33803 - Urological Supplies
Related National Coverage Documents
Public Versions
Updated On Effective Dates Status
06/05/2020 06/11/2020 - N/A Currently in Effect You are here


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