LCD Reference Article Response To Comments Article

Response to Comments: External Infusion Pumps - DL33794

A58802

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Article ID
A58802
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Article Title
Response to Comments: External Infusion Pumps - DL33794
Article Type
Response to Comments
Original Effective Date
06/03/2021
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During the 45-day comment period, which was open from 12/17/2020 through 01/30/2021, the DME MACs received a total of 22 comments* from 10 commenters.

* This count refers to the total comments/submissions received on this proposed local coverage determination as of January 30, 2021. Note: The MACs review all submitted comments; however, MACs may choose to consolidate similar thematic comments, redact or withhold certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language or duplicate/near duplicate submissions from a mass-mailing campaign. This can result in discrepancies between this count and the number of responses to comments.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period on the proposed External Infusion Pumps Local Coverage Determination (LCD).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Accordingly, the final policy and our response to comments are based on the best currently available published clinical evidence, to support optimal health outcomes in Medicare beneficiaries with a diagnosis of chronic inflammatory demyelinating polyneuritis (CIDP).

 

Response To Comments

Number Comment Response
1

Several commenters supported coverage of Hizentra for CIDP as proposed.

The DME MAC Medical Directors would like to thank the beneficiaries, suppliers, physicians, manufacturers, associations, and others for taking the time to submit detailed comments and support for the proposed changes to the External Infusion Pumps LCD. The policy will be finalized as proposed and will extend coverage of Hizentra for CIDP.

2

Two commenters requested additional diagnosis codes, G61.89 (other Inflammatory polyneuropathies) and G61.9 (inflammatory polyneuropathy, unspecified), be added to the policy article to support coverage of Hizentra.

The clinical literature supports the use of Hizentra for maintenance therapy in adults with CIDP. Coverage for Hizentra will be extended to beneficiaries with CIDP that has been identified by the specific ICD-10 diagnosis code G61.81. Use of the non-specific diagnosis code G61.9 (inflammatory polyneuropathy, unspecified) for CIDP would not be accurate. Additionally, currently, clinical literature does not exist that supports the efficacy of Hizentra for the treatment of other inflammatory polyneuropathies identified by G61.89. Therefore, no non-specific diagnosis codes will be added.

3

One commenter requested that Hizentra coverage for CIDP be limited to diagnosis G61.81 (Chronic inflammatory demyelinating polyneuritis) and requested the DME MACs refrain from adding other non-specific diagnosis codes to the policy article.

The DME MAC Medical Directors agree with this comment (See Response to comment #2).

4

Two commenters opposed coverage of Hizentra for CIDP due to the shifting of coverage from Medicare Part D to Part B and the higher out-of- pocket costs for some beneficiaries under Part B.

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD.

5

One commenter indicated concerns with beneficiaries’ treatment being adversely affected by adding coverage of SCIg and not IVIg.

Coverage of IVIg is under a separately defined benefit as outlined in the Social Security Act §§1861(s)(2)(Z) and 1861(zz). Coverage of IVIg is statutorily limited to beneficiaries with a diagnosis of primary immune deficiency disease.

6

One commenter indicated that the CIDP drug dose is higher than immunodeficient patients at 200-400 mg/kg/week which results in uncomfortable treatment for patients.

The treating practitioner should consider any concerns about safety, adherence, or potential side effects when ordering the appropriate treatment for the beneficiary’s condition.

7

One commenter indicated the proposed change would require the patient to administer their own medication, which would increase the potential for medication errors or patient non-compliance with prescribed therapy.

With regard to the coverage of the home infusion drugs, Medicare Part B covers a limited number of home infusion drugs through the DME benefit if:

(1) the drug is necessary for the effective use of an external infusion pump classified as DME and determined to be reasonable and necessary for administration of the drug; and

(2) the drug being used with the pump is itself reasonable and necessary for the treatment of an illness or injury. Additionally, in order for the infusion pump to be covered under the DME benefit, it must be appropriate for unsupervised use (i.e. does not required skilled services) in the home.

8

One commenter was concerned that patients would be forced to switch from IVIg to SCIg since one of the coverage criteria requires the patient has responded to IVIg therapy.

The treating practitioner should continue to choose the appropriate treatment option for the beneficiary. There is no requirement for beneficiaries to switch from IVIg to SCIg.

9

One commenter indicated concerns over backdating coverage of Hizentra to March 15, 2018 due to the administrative burdens it would pose on suppliers.

The DME MAC Medical Directors are aware that claims for Hizentra may have previously been billed to Part D. The coverage effective date for Hizentra for the maintenance therapy of CIDP under the DME benefit (Part B) will coincide with the effective date of the final LCD (July18, 2021).

10

One commenter requested the coverage effective date of Hizentra for CIDP be clarified as March 15, 2018.

Please see the response to comment #9. The coverage effective date for Hizentra for the maintenance therapy of CIDP under the DME benefit will coincide with the effective date of the final LCD (July 18, 2021).

11

One commenter requested confirmation that the transitional Home Infusion Therapy (HIT) benefit would apply to Hizentra retroactively based on the effective date of coverage.

Please see the response to comment #9. The coverage effective date for Hizentra for the maintenance therapy of CIDP under the DME benefit will coincide with the effective date of the final LCD (July18, 2021).

12

One commenter indicated that CMS should modernize the home infusion benefit rather than expand coverage using the DMEPOS External Infusion Pumps LCD reconsideration process.

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD. This comment should be directed to CMS.

13

Two commenters requested that coverage criteria be aligned for continuous glucose monitor (CGM) coverage under the Glucose Monitors LCD and the insulin infusion pump coverage under the External Infusion Pumps LCD.

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD. National Coverage Determination (NCD) 280.14 limits coverage of external insulin pumps to the criteria outlined in the current LCD. Information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess

14

Two commenters suggested modifying the coverage criterion for an insulin infusion pump to allow for multiple daily administrations instead of injections of any insulin to align with the CGM coverage criteria.

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD. National Coverage Determination (NCD) 280.14 limits coverage of external insulin pumps to the criteria outlined in the current LCD. Information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess

15

Two commenters suggested modifying the coverage criteria for an insulin infusion pump to no longer require glucose self-testing an average of 4 times a day as a pre-requisite for coverage to align with the CGM

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD. National Coverage Determination (NCD) 280.14 limits coverage of external insulin pumps to the criteria outlined in the current LCD. Information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess

16

One commenter requested removal of the coverage criterion that requires frequent self-adjustment of insulin dosing for at least 6 months prior to initiation of an external insulin pump.

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD. National Coverage Determination (NCD) 280.14 limits coverage of external insulin pumps to the criteria outlined in the current LCD. Information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess

17

One commenter requested that the coverage criteria allow for patients entering Medicare using OmniPod systems to qualify for coverage of an external insulin pump.

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD. National Coverage Determination (NCD) 280.14 limits coverage of external insulin pumps to the criteria outlined in the current LCD. Information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess

18

Several commenters requested modifying or removing the requirement that beneficiaries have a glycosylated hemoglobin level (HbA1C) greater than 7 percent as one of the potential qualifying pathways for external insulin pump coverage.

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD. National Coverage Determination (NCD) 280.14 limits coverage of external insulin pumps to the criteria outlined in the current LCD. Information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess

19

Two commenters requested removal of the coverage criterion requiring a positive beta cell autoantibody test to qualify for an external insulin pump.

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD. National Coverage Determination (NCD) 280.14 limits coverage of external insulin pumps to the criteria outlined in the current LCD. Information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess

20

Two commenters requested removal or modification to the continued coverage criterion for an external insulin pump and supplies that requires the beneficiary be seen and evaluated by the treating practitioner at least every 3 months.

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD. National Coverage Determination (NCD) 280.14 limits coverage of external insulin pumps to the criteria outlined in the current LCD. Information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess

 

21

Two commenters requested allowance of telehealth visits to meet the continued coverage requirements for external insulin pump and supplies.

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD. National Coverage Determination (NCD) 280.14 limits coverage of external insulin pumps to the criteria outlined in the current LCD. Information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess

22

One commenter requested a pathway to coverage for all 3 components of an interoperable closed-loop system (the CGM, insulin pump, and software).

This comment is outside the scope of the current LCD reconsideration request and the proposed changes to the LCD.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L33794 - External Infusion Pumps
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