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CMS publishes jam-packed proposed rule

CMS publishes jam-packed proposed rule Agency addresses non-bid areas, accessories for complex rehab manual wheelchairs, CGMs, external infusion pumps

WASHINGTON - CMS seeks to continue paying higher payment amounts to suppliers in non-competitive bidding areas as part of a DMEPOS proposed rule that it published on Tuesday afternoon.

The agency also seeks to: permanently exempt manual wheelchairs and accessories from the bid program; classify all continuous glucose monitors, not just therapeutic CGMs, as DME and establish payment amounts for them and their related supplies and accessories; and expand the classification of external infusion pumps under the DME benefit, increasing access to home infusion.

Changing to fee schedule adjustments

CMS seeks to establish the methodologies for adjusting the fee schedule payment amounts for DMEPOS items furnished in non-competitive bidding areas (non-CBAs) on or after April 1, 2021, or the date immediately following the duration of the public health emergency, whichever is later.

The agency proposes continuing to pay suppliers at higher payment amounts in rural and non-contiguous areas, in response to stakeholder input indicating higher costs in these areas, greater travel distances and costs in certain non-CBAs vs. CBAs; the unique challenges and costs of furnishing items in non-contiguous areas; significantly lower volume of items furnished in these areas vs. CBAs; and concerns about financial incentives for suppliers in surrounding urban areas to continue including outlying rural areas in their service areas.

CMS also seeks to pay 100% of the adjusted payment amount in non-rural, non-CBAs in the contiguous U.S.

For items that were included in Round 2021 but have been removed from that round, CMS is considering whether to simply extend application of the current fee schedule adjustment rules at 414.210(g)(9) for non-CBAs, and for CBAs and former CBAs, the fee schedule adjustment rules at 414.210(g)(10), until new SPAs are calculated for the items once competitive bidding of the items has been resumed.

The agency also seeks to finalize a previous interim final rule that resumed the transitional 50/50 blended rates for items furnished in rural areas and non-contiguous areas from June 1, 2018, through Dec. 31, 2018, and excluded infusion drugs from the bid program.

Expanding classification of external infusion pumps

CMS proposes that an external infusion pump would be considered “appropriate for use in the home” if 1) the U.S. Food and Drug Administration-required labeling requires the associated home infusion drug to be prepared immediately prior to administration or administered by a health care professional or both; 2) a qualified home infusion therapy supplier administers the drug or biological in a safe and effective manger in the patient's home; and 3) the FDA-required labeling specifies infusion via an external infusion pump as a possible route of administration, at least once per month, for the drug.

Under this proposal, CMS would clarify that in those circumstances in which an individual is unable to self-administer certain drugs that meet the criteria described above, such drug can be covered as a supply necessary for the effective use of an external infusion pump under the DME benefit, and that both the pump and the associated supplies can be covered under the DME benefit if reasonable and necessary, but only if the associated home infusion therapy services are also furnished and covered by Medicare.

Exempting complex rehab manual wheelchairs

CMS proposes revising the definition of “item” under the competitive bidding program to exclude complex rehab manual wheelchairs and certain other manual wheelchairs and related accessories from the bid program.

For a fact sheet on the proposed rule go here:

For the full proposed rule go here:


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