On October 27, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that establishes methodologies for adjusting the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule amounts using information from the Medicare DMEPOS competitive bidding program for items furnished on or after April 1, 2021 or the date immediately following the duration of the emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)), whichever is later; certain policies and procedures regarding the submission and evaluation of Healthcare Common Procedure Coding System (HCPCS) Level II code applications; and procedures for making benefit category determinations and payment determinations for DME, prosthetics, orthotics, and other new items and services under Medicare Part B to prevent delays in coverage of such items and services. In addition, this rule proposes to classify continuous glucose monitors as DME under Medicare Part B and establish fee schedule amounts for these items and related supplies and accessories. This proposed rule would also expand the interpretation of the appropriate for use in the home requirement within the definition of DME, specifically for external infusion pumps with the goal of increasing access to home infusion drugs. This proposed rule would also make conforming changes to the regulations related to implementation of section 106 of the Further Consolidated Appropriations Act, 2020 by changing the definition of item in the DMEPOS Competitive Bidding Program (CBP) to exclude complex rehabilitative manual wheelchairs and certain other manual wheelchairs and related accessories.
Changes to the DMEPOS Fee Schedule Adjustments
Background: This proposed rule establishes 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 emergency period described in section 1135(g)(1)(B) of the Social Security Act (42 U.S.C. 1320b–5(g)(1)(B)), whichever is later. The purpose of this proposal is to establish the methodologies for adjusting the fee schedule payment amounts for DMEPOS items furnished in non-CBAs on or after April 1, 2021 or the date immediately following the duration of the PHE for COVID-19.
Under the proposal, CMS would continue paying suppliers higher rates for furnishing items and services in rural and non-contiguous areas as compared to items and services furnished in other areas, informed by stakeholder input indicating higher costs in these areas, greater travel distances and costs in certain non-CBAs compared to CBAs, the unique logistical challenges and costs of furnishing items to beneficiaries in the non-contiguous areas, significantly lower volume of items furnished in these areas versus CBAs, and concerns about financial incentives for suppliers in surrounding urban areas to continue including outlying rural areas in their service areas. Previous feedback from industry stakeholders expressed concern regarding beneficiary access to items and services furnished in rural and remote areas. CMS would also pay 100 percent of the adjusted payment amount established under §414.210(g)(1)(iv) in non-rural non-CBAs in the contiguous U.S. CMS also discusses other alternatives considered to these methodologies.
For items that were included in Round 2021 but have essentially been removed from Round 2021 of the CBP, we are 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.
Changes to the DMEPOS Fee Schedule Adjustments for Items and Services Furnished in Rural Areas from June 2018 through December 2018 and Exclusion of Infusion Drugs from the DMEPOS Competitive Bidding Program
Background: The proposed rule addresses our intent to finalize and address comments received on the May 11, 2018 interim final rule (83 FR 21912) entitled “Medicare Program; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To provide Relief in Rural Areas and Non-Contiguous Areas” including comments related to the conforming amendment excluding infusion drugs from the DMEPOS CBP.
We indicate in the rule our plan to finalize the May 11, 2018 interim final rule (83 FR 21912) entitled “Medicare Program; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To provide Relief in Rural Areas and Non-Contiguous Areas” that resumed the transitional 50/50 blended rates for items furnished in rural areas and noncontiguous areas from June 1, 2018 through December 31, 2018, including the conforming amendment to exclude infusion drugs from the DMEPOS CBP.
Proposals Related to the Healthcare Common Procedure Coding System (HCPCS) Level II Code Application Process
Background:
CMS establishes and maintains certain codes under the Healthcare Common Procedure Coding System (HCPCS) Level II and is responsible for making decisions about additions, revisions and discontinuations to those codes. The procedures by which the public submits and CMS evaluates code applications to modify the HCPCS Level II code set have been primarily included in instructions and accompanying material released on the CMS website. To increase transparency and gather stakeholder input, CMS is proposing to codify certain policies and procedures regarding the submission and evaluation of HCPCS Level II code applications for products paid separately as drugs or biologicals, and non-drug, non-biological items and services, as defined in this proposed rule. CMS is proposing to codify the more frequent coding cycles as implemented January 1, 2020, including timeframes for application submission and final decisions, and to update associated policies and processes. CMS is also proposing processes that CMS would use to evaluate HCPCS Level II code applications to add a code, revise an existing code, or discontinue an existing code.
Changes to the Process for Making Benefit Category Determinations and Payment Determinations for DME and Other Items and Services under Part B
Background: This proposed rule proposes procedures for making benefit category determinations and payment determinations for new DME, prosthetics, orthotics, and other items and services under Medicare Part B that permit public consultation through public meetings. Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub L. 106-554) requires the Secretary to establish procedures for coding and payment determinations for new DME under part B of title XVIII of the Act that permit public consultation in a manner consistent with the procedures established for implementing coding modifications for ICD-9-CM (which has since been replaced with ICD-10-CM as of October 1, 2015). CMS decided to expand these procedures to HCPCS code request for items and services other than DME in 2005. CMS is proposing to establish in regulations a process that incorporates public consultation on benefit category determinations and payment determinations for new DME, prosthetics, orthotics, and other items and services under Part B.
Whether or not an item or service falls under a Medicare benefit category, such as the Medicare Part B benefit category for DME, is a necessary step in determining whether an item may be covered under the Medicare program and, if applicable, what statutory and regulatory payment rules apply to the items and services. If the item is excluded from coverage by the Act or does not fall within the scope of a defined benefit category, the item cannot be covered under Title XVIII. When the item is not excluded from coverage by the Act and is found to fall within a benefit category, CMS will need to determine what payment rules would apply to the item.
Therefore, CMS is proposing procedures for use in determining if items and services fall under the Medicare Part B benefit categories for DME, prosthetic devices, orthotics and prosthetics, surgical dressings, splints, casts and other devices for the reduction of fractures or dislocations, or therapeutic shoes and inserts, in order to promote transparency, continue our longstanding practice of establishing coverage and payment for new items and services soon after they are identified through the HCPCS code application process, and prevent delays in access to new technologies.
This proposed rule would establish procedures for making benefit category determinations and payment determinations for these items and services for which a HCPCS Level II code has been requested. Specifically, the purpose of the process would be to determine whether the product for which a HCPCS code has been requested meets the Medicare definition of DME, a prosthetic device, an orthotic or prosthetic, a surgical dressing, splint, cast, or other device used for reducing fractures or dislocations, or a therapeutic shoe or insert and is not otherwise excluded under Title XVIII, to determine how payment for the item or service would be made, and to obtain public consultation on these determinations.
Changes to the Classification and Payment for Continuous Glucose Monitors under Part B
Background: This proposed rule addresses classification and payment for continuous glucose monitors (CGMs) under the Medicare Part B benefit for DME.
This rule proposes to classify all CGMs as DME and addresses the payment for different types of CGMs, as well as supplies and accessories used with CGMs. Additional determinations regarding whether a CGM is covered in accordance with section 1862(a)(1)(A) of the Act, or is otherwise excluded under Title XVIII, will be made by DME MACs using the local coverage determination process or during the Medicare claim-by-claim review process.
Expanded Classification of External Infusion Pumps as DME
Background: The purpose of this rule is to revise our interpretation of the “appropriate for use in the home” requirement in the definition of DME as it applies to certain external infusion pumps. Specifically, we are proposing that an external infusion pump would be considered “appropriate for use in the home” if: 1) the Food and Drug Administration (FDA)-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 (defined at §486.505) administers the drug or biological in a safe and effective manner in the patient’s home (as defined at §486.505); 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.
Exclusion of Complex Rehabilitative Manual Wheelchairs and Certain Other Manual Wheelchairs from the DMEPOS Competitive Bidding Program
Background: Section 106 of the Further Consolidated Appropriations Act, 2020 excludes complex rehabilitative manual wheelchairs and certain other manual wheelchairs and related accessories from the DMEPOS CBP as well as from fee schedule adjustments based on information from the DMEPOS CBP. This provision became effective January 1, 2020, and we are currently implementing this provision through program instructions, as authorized by section 106 of the Further Consolidated Appropriations Act, 2020. This rule proposes to make conforming changes to the regulations to reflect section 106 of the Further Consolidated Appropriations Act, 2020.
This rule proposes to revise the definition of “item” under the CBP at 42 CFR 414.402 to exclude complex rehabilitative manual wheelchairs and certain other manual wheelchairs and related accessories as required by section 106(a) of the Further Consolidated Appropriations Act, 2020.
Download the proposed rule at: https://www.federalregister.gov/public-inspection/2020-24194/medicare-program-durable-medical-equipment-prosthetics-orthotics-and-supplies-policy-issues-and
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