Dexcom Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule

WASHINGTON, Sept. 11 -- Dexcom, San Diego, California, has issued a public comment on the Centers for Medicare and Medicaid Services proposed rule entitled "Medicare Program: CY 2021 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; etc.". The comment was written on Sept. 3, 2020, and posted on Sept. 4, 2020:

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Dexcom is pleased to have the opportunity to submit comments in response to the proposed Medicare CY 2021 Physician Fee Schedule, released by Centers for Medicare and Medicaid Services (CMS) on August 4, 2020.

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.

Our specific comments on the proposal are outlined below. To assist you in identifying the specific issue, we have used headings from the proposed rule and reference page numbers in the PDF version of the pre-publication document.

COMMENTS

b. Requests to Add Services to the Medicare Telehealth Services List for CY 2021 (page 77)

Under this heading CMS proposes to add codes GPC1X and 99XXX, among others, to the list of Category I telehealth services. Dexcom supports that proposal and agrees with the agency's rationale that "The add-on codes to the office/outpatient E/M services are, by definition, part of the office/outpatient E/M services since they cannot be billed with any other codes," and that consequently they should be added to the list of telehealth services.

4. Proposed Technical Amendment to Remove References to Specific Technology (page 111)

Under this heading, CMS proposes to make a technical correction to the definition of "Interactive telecommunications system" found in the regulation at 42 CFR 410.78(a)(3). Dexcom strongly supports the elimination of the final sentence of this definition. As CMS notes in the March 31st IFC, mobile computing devices colloquially referred to as "phones" that can be used in either an audio+video or audio-only mode are now ubiquitous and the wording of the regulatory text could be construed to prevent their use for purposes of conducting a telehealth service. For that reason, we support the agency's amendment to the regulation as proposed.

We note that the statutory text laying out the telehealth services benefit uses the term "telecommunications system" but does not include an explicit definition of that term, except to say that in the case of federal telemedicine demonstrations in Alaska or Hawaii, the term "includes store-and-forward technologies that provide for the asynchronous transmission of health care information in single or multimedia formats."/1

The statute therefore leaves it up to the Department of Health and Human Services (HHS) to determine whether a telehealth telecommunications system must include both audio and video capabilities and HHS is free to make the modification it proposes under this heading.

6. Comment Solicitation on Continuation of Payment for Audio-only Visits (page 115)

Under this heading, CMS asks for comment on whether separate payment for three specific telephone-only services (99441, 99442 and 99443) should be a provisional policy to remain in effect until a year or some other period after the end of the public health emergency, or if the policy should be made permanent.

Medicare coverage policy for insulin pumps, which are often used in conjunction with continuous glucose monitors (CGMs), requires the beneficiary to meet with the prescriber every three months./2

Coverage policy for CGMs requires such visits every six months./3

In addition to these required visits for ongoing coverage, when initiating therapy on these devices, beneficiaries may need frequent checks by their provider to ensure they are successfully transitioning to the use of these devices. For many beneficiaries, such frequent visits can pose serious challenges because of the difficulties and costs attendant to required travel. Visits designed to convey information about the use of these devices, or to ensure their ongoing utility and thus qualification for coverage, can easily be conducted via audio-only interaction.

As discussed above, HHS has broad discretion to establish a regulatory definition of the term "telecommunications system," as the statute provides only minimal guidance about the meaning of that term. We believe it important that the one provision in the statute that offers help to define this term indicates that it includes a store-and-forward technology that provides for transmission of information in a single format, which would lend support to the promulgation of a regulatory definition allowing coverage for audio-only services.

Dexcom supports making coverage for these codes permanent. This will allow Medicare beneficiaries accessing insulin pump and CGM therapy to do so efficiently and will help foster the use of these life-changing devices.

7. Comment Solicitation on Coding and Payment for Virtual Services (page 119)

Under this heading, CMS asks for comment on services that can be reimbursed as virtual services, rather than telehealth services, and states, "We are also seeking comment on physicians' services that use evolving technologies to improve patient care that may not be fully recognized by current PFS coding and payment."

Dexcom recommends that CMS allow for reimbursement of CPT codes 95249 and 95250 when performed as virtual services.

* 95249 is defined by the American Medical Association (AMA) as, "Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; patient-provided equipment, sensor placement, hook-up, calibration of monitor, patient training, and printout of recording."

* 95250, is defined as "Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; physician or other qualified health care professional (office) provided equipment, sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording."

These services have been provided as virtual services under commercial insurance programs with significant success and we believe that the Medicare population could benefit from this flexibility. Several recent publications have examined this practice.

One study examining the feasibility of initiating CGM therapy through telehealth used certified diabetes care and education specialists to provide instruction via videoconferencing or phone. In their reported results, the authors note that all study participants used CGM through the entire 12-week study period, with 94% of them using the device at least 6 days per week during the last quarter of the study. Their mean HbA1c decreased remarkably from 8.3% to 7.2%, their time in the ideal glucose range increased from estimated 48% to 59% and substantial benefits to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management. The authors conclude that "Remote CGM initiation was successful in achieving sustained use and improving glycemic control," as well as "improving quality-of-life indicators."/4

Another study looked at virtual training using Zoom during the ongoing pandemic for the initiation of therapy on the Medtronic MiniMed 670G, a device system that combines an insulin pump and a CGM. The authors conclude that "The CGM metrics were comparable between Pre- and Intra-COVID-19 training." The use of Zoom video conferencing had a 98% satisfaction score and the net promotor score for this method of training rose from 78 for those in a traditional in-person training format prior to the COVID-19 pandemic to 84 for those doing so via Zoom during the COVID-19 pandemic. Notably, the time between the pump shipment and the first and last training was significantly reduced from 14+-7 days to 11+- 5 days. The authors conclude that "Virtual training of individuals with diabetes on the MiniMedTM 670G system resulted in high satisfaction and short-term glycemic results comparable to in-person training."/5

Researchers presenting at the recent Advanced Technologies Treatments for Diabetes Conference (ATTD) conference in Madrid, Spain reported on a study of virtual initiation of CGM therapy among nearly 600 adults with Type 2 diabetes. Their study found that:

* On a 1-5 scale, the overall CGM satisfaction score was 4.5+/-0.8.

* The majority of respondents (94.8%) agreed/strongly agreed that they were comfortable inserting the sensor remotely with guidance from their coach and that real time CGM use:

- improved understanding of the impact of eating (97.0%);

- increased diabetes knowledge (95.6%); and

- helped improve diabetes control when not wearing the sensor (79.5%).

* Most respondents (70.5%) disagreed/strongly disagreed that real time CGM provided too much information.

* HbA1c (n?=?372) decreased significantly from 7.7%+/-1.6 to 7.1%+/-1.2 overall and by 2.6%+/-2.0, 0.9%+/-1.4 and 0.4%+/-0.8, for participants with baseline HbA1c levels of >9.0%, 8.0%-9.0%, and 7.0%-<8.0%, respectively (all p?<?0.001; mean follow-up 10.2 months).

The authors concluded that it is feasible to provide CGM directly to individuals with Type 2 diabetes through virtual clinic visits without any in-office training and that use of the CGM was well-received by adults with Type 2 diabetes and associated with improved HbA1c./6

We believe that allowing the initiation of both personal and professional CGM therapy through a virtual visit will reduce barriers associated with travel and difficulty accessing a trained provider that are experienced by Medicare beneficiaries. The evidence from the studies cited above amply demonstrates that these services can easily and successfully be completed virtually and that permitting this as an option will make it easier for Medicare beneficiaries to access CGM therapy. There is a very large body of evidence conclusively demonstrating that CGM therapy results in substantial improvements in glycemic control and it is in the best interest of the Medicare program to foster its use. For those reasons, we respectfully request that the agency permit virtual provision of CPT codes 95249 and 95250.

We also note a particular challenge associated with 95250. This code covers the use of a professional CGM for a limited time. A provider may use this service when he/she suspects that a patient's glycemic levels are not within normal range and to gather data on precisely what is occurring. In many of these situations, the provider and patient will discover through the use of the professional CGM, that indeed the patient is experiencing significant glycemic excursions that require therapeutic intervention or behavioral modifications to address. The best way for a patient to see whether those changes are working is to see their real time glucose levels respond to those actions. To do so, they need to transition to a personal CGM.

While we acknowledge that it is outside the scope of this proposed rule, we recommend that CMS give serious consideration to allowing the demonstration of glycemic excursion through the use of a professional CGM to be sufficient basis for coverage of a personal CGM covered under the DME benefit.

CONCLUSION

We thank the agency for the opportunity to submit comments. Should you have any questions, please reach out to Jesse Bushman at [email protected].

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Footnotes:

1/ Section 1834(m) of the Social Security Act

2/ See: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=223&bc=AgAAQAAAAAAA&ncdver=2

3/ See: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33822&ver=26&SearchType=Advanced&CoverageSelection=Both&NCSelection=NCD&PolicyType=Final&s= 23|45|48&KeyWord=insulin+infusion&KeyWordLookUp=Doc&KeyWordSearchType=And&kq=true&bc=IAAAABAAAAAA&

4/ Gal, R.L., Cohen, N.J., Kruger, D., Beck, R., Bergenstal, R.M., Calhoun, P., Cushman, T., Haban, A., Hood, K., Johnson, M.L. Diabetes Telehealth Solutions: Improving Self-Management Through Remote Initiation of Continuous Glucose Monitoring. Journal of the Endocrine Society, Volume 4, Issue 9, September 2020, https://doi.org/10.1210/jendso/bvaa076

5/ Vigersky, R.A., Velado, K., Zhong, A., Agrawl, P., Cordero, T.L. The Effectiveness of Virtual Training on the MiniMedTM 670G system in people with type 1 diabetes (T1D) during the COVID-19 Pandemic. Diabetes Technology and Therapeutics (DOI: 10.1089/dia.2020.0234). This paper has been peer-reviewed and accepted for publication, but has yet to undergo copyediting and proof correction. The final published version may differ from this proof.

6/ Zisser, H., Layne, J., Bergenstal., R., Barleen, N., Miller, D., Moloney, D., Majithia, A., Gabbay, R., Parkin, C., Dixon, R. Remote Application and Use of Continuous Glucose Monitoring by Adults with Type 2 Diabetes in a Virtual Diabetes Clinic. The Official Journal of ATTD Advanced Technologies & Treatments for Diabetes Conference Madrid, Spain--February 19-22, 2020. Oral Presentation. Session 08. Abstract ID 247.

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The proposed rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0088-1604

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