(a) General rule. CMS establishes a single payment amount for each item furnished under a competitive bidding program.

(b) Methodology for setting payment amount. (1) Notwithstanding paragraphs (b)(2) and (3) of this section, a single payment amount for a lead item furnished under a competitive bidding program is equal to the 75th percentile of bid amounts submitted for that item by suppliers whose composite bids for the product category that includes the item are equal to or below the pivotal bid for that product category. If the 75th percentile of bid amounts falls between 2 bidding entities, the SPA is determined by using the amount that is 75 percent between the two bid amounts, rounded to the nearest cent.

(2) The single payment amount for an item in a product category furnished under a competitive bidding program that is not a lead item for that product category (non-lead item) is equal to the single payment amount for the lead item in the same product category multiplied by the ratio of the 2015 fee schedule amount for the non-lead item for the applicable area to which the fee schedule amount applies (State, District of Columbia, Puerto Rico, or United States Virgin Islands) to the 2015 fee schedule amount for the lead item for the same area.

(3) The single payment amount for an item included in a product category in a remote item delivery competitive bidding program furnished under a competitive bidding program that is not a lead item for that product category (non-lead item) is equal to the single payment amount for the lead item in the same product category multiplied by the ratio of the average 2015 fee schedule amount for the non-lead item for the applicable area to which the fee schedule amount applies (State, District of Columbia, Puerto Rico, or United States Virgin Islands, a combination thereof, or nationwide) to the average 2015 fee schedule amount for the lead item for the same area.

(i)(A) The 2015 fee schedule amounts for a continuous glucose monitor and supplies are calculated using the 2025 fee schedule amounts and removing the covered items update factors for years 2016 through 2025 specified under section 1834(a)(14) of the Act.

(B) The 2015 fee schedule amounts for the bundled monthly rental of a continuous glucose monitor are calculated by adding the 2015 fee schedule amount for the supplies to the average of the 2015 fee schedule amounts for the purchase of a new continuous glucose monitor divided by 60 for the areas included in the remote item delivery CBP.

(ii) The 2015 fee schedule amount for the monthly supplies for a continuous glucose monitor owned by a beneficiary is calculated using the 2025 fee schedule amount and removing the covered item update factors for years 2016 through 2025 specified under section 1834(a)(14) of the Act.

(iii) The 2015 fee schedule amounts for the bundled monthly rental of an insulin infusion pump and supplies and accessories are calculated using the average 2015 fee schedule amounts for the insulin infusion pump multiplied by 10.5 and divided by 60 for the nonrural areas included in the remote item delivery CBP, and then adding the average 2015 fee schedule amounts for the sterile syringe type cartridge for the insulin infusion pump multiplied by 9 for the nonrural areas included in the remote item delivery CBP plus the average 2015 fee schedule amounts for the weekly insulin pump supplies multiplied by 4 for the areas included in the remote item delivery CBP.

(iv) The 2015 fee schedule amounts for the monthly supplies and accessories for an insulin infusion pump owned by a beneficiary is calculated using the average 2015 fee schedule amounts for the sterile syringe type cartridge for the insulin infusion pump multiplied by 9 for the areas included in the remote item delivery CBP plus the average 2015 fee schedule amounts for the weekly insulin pump supplies multiplied by 4 for the areas included in the remote item delivery CBP.