Local Coverage Article Response to Comments

Response to Comments: Prostate Rectal Spacers


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Article ID
Article Title
Response to Comments: Prostate Rectal Spacers
Article Type
Response to Comments
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the LCD for Prostate Rectal Spacers. The official notice period for the final LCD begins on June 11, 2020 and the final determination will become effective for services rendered on or after August 1, 2020.

Response To Comments


The American Society for Radiation Oncology (ASTRO) noted they “appreciate the addition of coverage associated with moderate hypofractionated radiation therapy” and then recommended changes to spacer selection criteria, in general, noting recent changes to the National Comprehensive Cancer Network (NCCN) criteria. They also included a comment recommending coverage during brachytherapy.

Only the addition of coverage for hypofractionated RTX was open for official comment. Comments not specific to hyofractionated RTX (e.g., related to overall selection criteria or other forms of RTX) may be submitted as a reconsideration request once the revised policy becomes effective.


A practicing radiation oncologist and Carrier Advisory Committee (CAC) member commented that while the addition of moderate hypofractionation is “an important step” …. in recognizing “the concept of BED (biologically equivalent doses), “a consideration should be made for extending this to patients who receive ‘ultrafractionation’, in which the entire course of therapy is only 5-7 treatments and the dose per treatment is 5 Gy.” Cited in support was a recent Scandinavian randomized controlled trial (RCT) “comparing 78 Gy in 39 fractions to 42.7 Gy in 7 fractions found no significant differences in outcomes between the two groups in terms of prostate cancer outcome or late adverse events” (Widmark). A reference to an analysis suggesting use of a spacer for patients receiving high dose stereotactic body radiotherapy (SBRT) would be cost-effective was also provided.(Hutchinson) Other comments included recommendations related to overall spacer selection criteria and brachytherapy.

The Widmark study would seem to be an important step towards establishing more widespread acceptance of ultrafractionation as an alternative to conventionally-fractioned RTX. However, we did not receive comments that would indicate that overall societal acceptance, as outlined in the draft LCD, has yet shifted. As for the overall selection criteria and brachytherapy related comments, please see response to comment #1.

Widmark A, Gunnlaugsson A, Beckman L, et al. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019;394(10196):385-395.

Hutchinson RC, Sundaram V, Folkert M, Lotan Y. Decision analysis model evaluating the cost of a temporary hydrogel rectal spacer before prostate radiation therapy to reduce the incidence of rectal complications. Urol Oncol. 2016;34(7):291 e219-226.

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