LCD Reference Article Response To Comments Article

Response to Comments: Implantable Continuous Glucose Monitors (I-CGM) DL38686

A58396

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A58396
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Response to Comments: Implantable Continuous Glucose Monitors (I-CGM) DL38686
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Response to Comments
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10/11/2020
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This article summarizes the comments WPS received for Draft Local Coverage Determinations (LCD) Implantable Continuous Glucose Monitors (I-CGM) DL38686. Thank you for the comments.

Response To Comments

Number Comment Response
1

Juvenile Diabetes Research Foundation (JDRF) writes today to strongly support the conclusion within this proposed LCD that, “coverage of this device will be in line with current CGM criteria.” When finalized, this LCD will make an important new option available to Medicare beneficiaries with diabetes and we express our appreciation for this decision. As outlined below, we suggest that some modifications be made to the eligibility criteria to facilitate the use of this important technology. We also support payment under the physician fee schedule (PFS), as proposed.

JDRF introduced themselves and provided information about type 1 diabetes and the value of CGM’s.

SPECIFIC ISSUES AND REQUESTS

Coverage. First and foremost, we applaud the decision in this proposed LCD to extend coverage to implantable CGM technology. It will offer an important new option to the hundreds of thousands of Medicare beneficiaries who are dependent on accurately controlling their blood glucose levels to maintain their health. We express our appreciation for this proposal and hope that it can be finalized expeditiously.

Eligibility Criteria. The proposed LCD includes several eligibility criteria for implantable CGM, including a requirement that the beneficiary “has been using a blood glucose monitor (BGM) and performing frequent (four or more times a day) testing.

Some beneficiaries may choose to transition to an implantable CGM from another CGM technology and will therefore not have been performing finger stick testing using a blood glucose meter. We therefore recommend that you clarify that it is acceptable for a beneficiary to transition to an implantable CGM from another CGM technology without intermediate use of finger stick testing and a blood glucose meter.

Further, Medicare’s basic benefit for finger stick test strips is for three per day. While it is possible to secure coverage for four or more test strips per day, it involves more paperwork and administrative hurdles for patients, providers and DME suppliers. Some DME suppliers are very reluctant or refuse to provide four or more test strips per day because they are very concerned about their ability to successfully pass through an audit given that they do not control the records necessary to demonstrate the need for the additional test strips. This can make it very challenging for Medicare beneficiaries to obtain four or more test strips per day. Finally, data from two important studies have shown that there is no difference in the outcomes of CGM usage between those patients who tested with 4 or more finger sticks and those who tested with fewer than 4 prior to initiating CGM therapy. An article reporting on these subgroup analyses concluded that “there is no evidence that frequent SMBG or type of diabetes is predictive of successful outcomes with CGM use.”13 We therefore recommend that the LCD be modified to eliminate the requirement for 4 finger sticks per day, or permit coverage of implantable CGM based on use of three or more test strips per day for new CGM users.

The proposed LCD requires that the patient be treated with “injections” of insulin in order to receive coverage for a CGM. There is at least one form of inhaled insulin on the market. To accommodate that reality, we suggest that this wording within the LCD be modified to require “administrations” of insulin.

The proposed LCD requires a visit with the prescribing professional at least every six months. The only implantable CGM on the market, the subject of this proposed LCD, must be replaced every 90 days. Therefore, patients will by default be seeing the professional who manages this service at least that frequently. The manufacturer of the device is working to get approval for a 180-day version of the device, which would still necessitate a visit with the prescribing professional every six months. In the case of this CGM, it would seem that a requirement that the patient visit with the prescriber at least every six months would be unnecessary since the nature of the device already requires that. Consequently, the inclusion of this as an eligibility requirement simply creates a paperwork burden for patients, providers and suppliers, that could be eliminated. If CMS chooses to retain a requirement for periodic visits, we believe that this requirement should be modified to require visits at least once per year, and only more frequently if the provider and patient determine it necessary to do so. Some beneficiaries are well stabilized on their treatment regimens and requiring very frequent visits simply entails extra costs and paperwork burden for them, the providers, the suppliers and CMS claims processing contractors. Jesse Bushman

Thank you for your comments. WPS has eliminated the 4 times per day requirement from the final LCD. We also agree that requiring the in person every 6 months visits when the device is to be replaced is unnecessary and the requirement is being removed from this LCD. We also agree that because there is another option for insulin therapy that comes in a non-injectable form, the verbiage will be changed to “insulin administrations” rather than “injections”. An exception statement will be added to the LCD allowing transition to an I-CGM in instances where a beneficiary has previously met coverage criteria for a non-implantable continuous glucose monitor and subsequently chooses to switch to an implantable device. This will require the treating provider’s cooperation and involvement as a small procedure is required to implant the I-CGM sensor.

2

Senseonics, Inc. (Senseonics) is pleased to submit this letter to Wisconsin Physician Services in response to the proposed Local Coverage Determination (LCD): Implantable Continuous Glucose Monitor(ICGM) (DL38686). Senseonics welcomes the ongoing efforts by the Medicare Administrative Contractors (MACs) to create an LCD specific to I-CGM.

Senseonics introduced themselves and Eversense®, which they manufacture.

Specifically, Senseonics asks that WPS modify Criterion 2 of the coverage criteria to ensure access for
Medicare beneficiaries that is in line with current clinical standards. WPS requires that “the beneficiary
has been using a blood glucose monitor (BGM) and performing frequent (four or more times a day)
testing”. There are two challenges associated with this requirement. First, many individuals with insulindependent diabetes currently use a traditional CGM and may want to move to an implantable option to better suit their diabetes management approach. These individuals would not be performing frequent testing as this is not required for use with traditional CGM per current FDA labelling.2 The current language would inadvertently preclude patients from I-CGM as it is currently written.

Second, there is insufficient data to support a specific number of self-monitoring of blood glucose tests that should be performed to predict the effectiveness of CGM. According to the most recent publication in the American Diabetes Association’s “Standards of Medical Care in Diabetes” for use of Diabetes Technology, the guidelines recommend, “When prescribing CGM devices, robust diabetes education, training and support are required for optimal CGM device implementation and ongoing use. People using CGM devices need to have the ability to perform self-monitoring of blood glucose in order to calibrate their monitor and/or verify readings if discordant from their symptoms.”3 There is no recommendation on how many tests per day should be performed for optimal use, but rather the clinical guidelines focus more on education and training. Given this recommendation, Senseonics asks that this criterion be rephrased to state “The beneficiary has been using a blood glucose monitor (BGM) as prescribed by their clinician or the beneficiary has been using a CGM device previous to an I-CGM”. Chip Moebus

Thank you for your comments. Please see our response to comment number 1.

3

The Endocrine Society is pleased to offer the following comments on the proposed local coverage determination (LCD) on implantable continuous glucose monitors (I-CGM), DL38686.

We agree that the proposed LCD includes proposed coverage criteria for I-CGMs that is aligned with the CGM class of devices. However, we recommend that you change the blood glucose self-testing requirements for I-CGMs in coverage criteria #2 from at least four times per day to at least three times per day. This is consistent with current Medicare coverage policy for test strips and with the scientific and clinical recommendations from experts in diabetes care. Requiring testing four times per day will limit patients who currently use other CGM systems, and this requirement is not supported by data to be a predicate requirement for coverage. Furthermore, the Society would like to see language added to the coverage criteria to account for patients who have adopted other CGM systems and may have had trouble complying, managing them, and cases when the CGM might not be appropriate anymore in light of other CGM options, like I-CGM. Robert Lash, MD

Thank you for your comments. Please see our response to comment number 1.

4

We received identical letters from both Diabetes Technology Coalition (DTC) and The Association of Diabetes Care & Education Specialists (ADCES).

Both organizations introduced themselves along with providing information on CGM’s and stating the CMS requirements for Medicare coverage of therapeutic CGM.

The DTC/ADCES urges you to modify the current Medicare local coverage criteria proposed for implantable I-CGMs so it is consistent with other existing Medicare coverage policy and clinical recommendations by experts in the field of diabetes, and recognizes individual insulin product preferences.

As you know, current Medicare policy covers only three (3) test strips daily for beneficiaries that are using insulin, which makes the four (4) times a day blood glucose self-testing requirement for coverage of I-CGMS burdensome and unworkable for patients.

Furthermore, clinical practice guidelines and recommendations from organizations representing experts in the field of endocrinology and diabetes do not support limiting CGM access to only people who have a demonstrated a history of blood glucose self-testing at least four (4) times per day. The consensus among the clinical practice guidelines and recommendations is that CGMs can help certain individuals better manage their diabetes by providing actionable data for the adjustment of insulin and optimal glucose control.

The American Diabetes Association Standards of Medical Care in Diabetes Recommendations for CGMs conclude the following:

  • “People who have been successfully using continuous glucose monitors should have continuous access across third-party payers.
  • When used properly, real-time continuous glucose monitoring in conjunction with intensive insulin regiments is a useful tool to lower A1C in adults with type 1 diabetes who are not meeting glycemic targets.
  • Real-time continuous glucose monitoring may be a useful tool in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes.
  • Real-time continuous glucose monitoring should be used as close to daily as possible for maximal benefit.”

These standards of care are backed by data. Two important studies have shown that there is no difference in the outcomes of CGM usage between those patients who tested with 4 or more finger sticks and those who tested with fewer than 4 prior to initiating CGM therapy. An article reporting on these subgroup analyses concluded that “there is no evidence that frequent SMBG or type of diabetes is predictive of successful outcomes with CGM use.”

Expanding access to I-CGMs will improve the health outcomes of beneficiaries with diabetes by improving glycemic control and reducing disease complications. Current Medicare policy requiring blood glucose self-testing of at least four (4) times per day is a barrier that impedes access to CGM technology by patients who could benefit from its use. We urge that you change the blood glucose self-testing requirement for I-CGMs to at least three (3) times per day, consistent with Medicare coverage policy for test strips and current scientific understanding and clinical recommendations from the experts in diabetes care.

We also recommend modification of the wording related to insulin treatment to eliminate the word “injections.” There is an inhaled insulin on the market used by some patients. To accommodate that reality, the wording should reflect “multiple daily administrations” with insulin, not “injections.”

Lastly, we ask that you strongly consider permanent adoption of the temporary waiver CMS issued under the COVID-19 Public Health Emergency that permits face-to-face office visit requirements for Medicare coverage of certain services to be performed by telehealth. Utilizing telehealth for the required biannual office visit to maintain CGM coverage will continue important new safety protocols for people with diabetes and providers and will reduce the administrative and resource burdens associated with a face-to-face in-office visit that can be just as effectively performed by telehealth. Ellie Tollefson (DTC) and Kate Thomas (ADCES)

Thank you for your comments. Please see our responses in comment number 1. Regarding the permanent adoption of the temporary waiver CMS has issued, this matter is beyond the scope of this LCD.

5

The Medcial Device Manufacturers Association (MDMA) introduced themselves and applauded the efforts of the Medicare Administrative Contractors to work expeditiously and cohesively to develop a consistent coverage landscape for Implantable Continuous Glucose Monitors (I-CGM) through the Local Coverage Development process.

MDMA would also like to comment around this renewed look at how Category III CPT codes are being viewed by the Medicare Administrative Contractors as historically this has been a very difficult and potentially short-sighted process in developing access to new medical technologies. Given most new technology must first utilize a Category III CPT code to establish market uptake it has been difficult to deliver that market uptake in the face of non-coverage. The establishment of an LCD for I-CGM proves that newer innovation can be supported by clinical evidence such that the scientific community can agree on its impact on health outcomes, irrespective of its current coding status. We ask that the Contractors continue to evaluate new technology based on its current evidence and potential impact on health outcomes versus categorically denying their coverage merely because of the code that supports that technology.

We also recommend that you eliminate the 4X per day SMBG testing in Criteria #2 as this will limit patients who are currently using other CGM systems and there is no data that supports more effective CGM use with 4X per day testing as a predicate requirement for coverage.

We thank CMS and the MACs for their work on this particular LCD and hope that there will be continued vigilance around assessing new technology that comes to the forefront in treatment and management of other health conditions. Mark Leahey

Thank you for your comments. Please see our response to comment number 1. The review of category III CPT codes is not within the scope of this LCD.

6

As an emissary of the American Association of Clinical Endocrinologists (AACE) and Tri-County Endocrinology & Nuclear Medicine, P.C., a comprehensive General Endocrinology Group Practice in Sterling Heights, Michigan, thank you for taking the time to consider my perspectives with regard to the Wisconsin Physicians Service Insurance Corporation’s (WPS) recently proposed Local Coverage Determination (LCD) criteria for Implantable Continuous Glucose Monitors (DL38686) as a clinical and therapeutic requisite for comprehensive Diabetes Management within the optional framework of your integrated health benefits model.

AACE discussed CGM and their support of the Eversense® Implantable 90-day Personal Continuous Glucose Monitor (CGM) System

In response to the proposed Local Coverage Determination (LCD) standards (DL38686) as would pertain to the acquisition of an Implantable Continuous Glucose Monitor (ICGM) System (i.e. Eversense® Implantable 90-day Personal Continuous Glucose Monitor), please consider the following criteria modifications as suggested below and specific to “criterion #2” (sub-statement 2a;) with possible inclusion of a “criterion #3”, in an effort to circumvent a Medicare beneficiary’s inadvertent exclusion as a clinically suitable candidate for implementation of or transition to, implantable CGM technology:

Therapeutic I-CGMs are considered reasonable and necessary by Medicare when all of the following coverage criteria (1-7) are met:

  1. The beneficiary has diabetes mellitus (Refer to the related Billing and Coding Article for applicable diagnoses); and,
  2. The beneficiary has been using a blood glucose monitor (BGM) and performing frequent (four or more times a day) testing; and,
    1. The beneficiary has been using a blood glucose monitor (BGM) and/or external continuous glucose monitor (E-CGM) to facilitate frequent (≥ 4 times per day) testing
  3. Impediments medically compromising to the beneficiary (i.e. lipodystrophy, site disruption, adhesive allergies, impaired dexterity) precludes the practical and efficient use of an E-CGM device
  4. The beneficiary is insulin-treated with multiple (three or more) daily injections of insulin or a Medicare-covered continuous subcutaneous insulin infusion (CSII) pump; and,
  5. The beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of BGM or CGM testing results; and,
  6. Within six (6) months prior to ordering the I-CGM, the treating practitioner has an in-person visit with the beneficiary to evaluate their diabetes control and determined that criteria (1-4) above are met; and,
  7. Every six (6) months following the initial prescription of the I-CGM, the treating practitioner has an in-person visit with the beneficiary to assess adherence to their I-CGM regimen and diabetes treatment plan.

I-CGM devices will not be considered reasonable and necessary for the following:

  1. Individuals that do not require insulin therapy.
  2. Short-term I-CGM (72 hours to 1 week) for diagnostic use.

With regard to the above suggested modifications as relates to “criterion #2” and the addition of a “criterion #3”, kindly note that many individuals with insulin dependent/requiring diabetes currently use a traditional CGM and may wish to acquire the implantable option to better suit their personal needs and approach to diabetes management. Such individuals may not be performing frequent BGM testing as this is not required with traditional CGM utilization per current FDA labelling19. Furthermore, of patients that are using E-CGM technology, standard of care is such that adjunctive BGM testing is primarily required for “calibration” purposes only at a frequency of 2-3 times per day (though occasionally to verify readings discordant from symptoms). The American Diabetes Association’s “Standards of Medical Care in Diabetes” guidelines for use of Diabetes Technology simply recommends that, “when prescribing CGM devices, robust diabetes education, training and support are required for optimal CGM device implementation and ongoing use. People using CGM devices need to have the ability to perform self-monitoring of blood glucose in order to calibrate their monitor and/or verify readings if discordant from their symptoms.”20 There is no recommendation on specifically how many tests per day should be performed for optimal use, but with guidelines emphasizing primarily the requisite for education and training. Eric S. Langer, D.O., M.A.C.O.I., F.A.C.E., C.C.D.

Thank you for your comments. Please see our response to comment number 1.

7

Thank you for the opportunity to comment on your decision to cover implantable CGM for the Medicare population. By way of introduction, I am the CEO of The diaTribe Foundation and Close Concerns, organizations designed to support, educate and inform people with diabetes and their health care providers, as well as the broader community involved in diabetes care, technology, innovation and coverage. We estimate that we reach over 250,000 people a month between our diaTribe and Close Concerns newsletters, which are disseminated multiple times a week.

First, we would like to take this opportunity to recognize the service you have done for people with diabetes in the Medicare age group by allowing them to have the option to use an implantable CGM. We are aware that CMS took a very expeditious approach to make this latest innovative option available. Since CGM is the standard of care for intensively managed diabetes, having options for patients is critical to advance CGM’s usage so that long term outcomes can improve and people with diabetes can remain healthier.

We would like to support your coverage criteria that are in line with the CGM class of devices. We do believe it is important for CMS to permanently remove the requirement for four SMBG blood tests per day, as suggested in Criteria #2, and we wonder if you would be able to help with this. We believe this limits access to the implantable CGM for patients who are currently using another CGM system and who, therefore, are no longer doing SMBG blood tests. Ultimately, we are not aware that doing four SMBGs a day is required for successful CGM usage.

Again, thank you for allowing us to send in our comments and for your decision to include implantable CGM as a benefit for Medicare patients. Thank you so much for all your care for people with diabetes and particularly those who are disabled as well as veterans. The two of us have had diabetes for nearly 60 years combined and along with our teams, we would love to see implantable technology made more available to people with diabetes more broadly, particularly those on Medicare who will improve with reduced barriers. Kelly Close and Monica Oxenreiter

Thank you for your comments. Please see our response to comment number 1.

8

My name is Kurt Midyett and I specialize in the treatment and management of Diabetes and Endocrine
Disorders in the Overland Park area of Kansas City in the Midwest Women and Children’s Specialty Center. I have been in practice in this area for 20 years and have an extensive experience using Continuous Glucose Monitors (CGM) systems, including implanted CGM.

I have been implanting and removing Eversense for quite some time and believe it is a necessary option for people with diabetes. I believe the procedure is easy to do once trained, and my patients seem to agree.

I would like to submit my comments to Medicare regarding the development of the Local Coverage
Determination for Implantable CGM, DL38686. I am very pleased to see WPS develop an LCD that is
favorable to this class of implanted CGM. This will enable more patients to be able to use this type of
technology.

Since CGM has been proven to be such an important addition to the care of insulin-taking type 1 and type 2 patients, it is important to have choices for patients who need CGM. There are many unique features to Eversense – which makes it the CGM of choice for many of my patients with diabetes. Particularly in the Medicare population, having it implanted, having a transmitter that gives vibratory alerts, and having an easy to apply transmitter with a mild adhesive often makes it the only CGM that will work for specific patients.

This device has been transformative for many of my patients. My patients that work with their hands and might not have quick access to their phones can receive the vibratory alerts from the Eversense and allow them to prevent the development of significant high or low blood sugars. Patients who are hard of hearing have seen benefit from the Eversense CGM vibratory alert system since all other CGMs use auditory alerts. Dexterity can be an issue for some of my older patients and the Eversense eliminates the need for at home sensor placement. Additionally, a frustration with CGM devices can be site adhesion. The Eversense is unique in regard to this issue. If there is a loss of adhesion from the tape, it only requires a simple change in the tape to reattach the transmitter. There is no loss of the sensor, which happens in all the other current CGMs on the market. This provides better continuity for the patient and also help to decrease costs and wasted sensors.

Hopefully, your agreement to cover will also encourage commercial carriers to cover implanted CGM who do not already cover the system.

Personally, I am hoping you will reconsider the criteria #2 of requiring 4 or more fingerstick blood glucose measurements per day. I am also hoping you realize that since the sensor needs to be replaced every 90 days, that requiring 6-month visits is not necessary since the patients are being seen at an even greater frequency.

Thank you for the opportunity to provide comments on the proposed LCD. My staff and I are happy to see Medicare take a very progressive approach in giving Medicare patients access to innovative technology. For the first time in my recent memory, patients with Medicare will have broader access to CGM technology than commercially insured patients. I know my patients with Medicare will be very happy to have this option for their care. Kurt Midyett, MD

Thank you for your comments. Please see our response to comment number 1.

9

I appreciate the chance to send in my comments concerning the Eversence CGM system and the development of the Local Coverage Determination for Implantable CGM, DL38686. I am pleased to see WPS develop an LCD supportive of implantable CGM.

Belinda Childs introduced herself and gave support of the Eversence system.

I do want you to know that I see my Eversense patients every 90 days to replace their sensors. I also want to ask if you could reconsider the 4 blood glucose tests a day as a requirement. This is difficult because many older individuals to not eat three meals a day, therefore there is no need for them to monitor four times a day, they do premeal which is first meal, second meal and bedtime. In addition, many DME suppliers will not accept our four times a day request stating that Medicare only allows three readings per day. We should not make our older population jump through these hoops to get safe care including CGM with alarms. Belinda Childs, APRN

Thank you for your comments. Please see our response to comment number 1.

10

The Advanced Medical Technology Association (AdvaMed) is pleased to submit the following comments to Wisconsin Physicians Services (WPS) in response to its proposed Local Coverage Determination (LCD): Implantable Continuous Glucose Monitors (I-CGM) (DL38686).

AdvaMed’s member companies produce the life-saving and life-enhancing medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

AdvaMed is encouraged by WPS’ efforts to develop local coverage policies specific to implantable CGM for individuals with diabetes. We appreciate WPS’ approach to making innovation for diabetes management available to Medicare beneficiaries. Medicare beneficiaries with diabetes and needing to manage their insulin must have access to a range of CGM options including implantable technologies that can help them better manage their glucose levels.

We also support the development of LCDs that include coverage of new technologies, as described in the related Coding and Billing article, that are identified by Category III CPT Codes 0446T, 0447T and 0448T describing insertion and removal of an implantable glucose sensor.

We note that the draft LCD currently requires, as a criterion for coverage that a beneficiary has been using a blood glucose monitor (BGM) and performing frequent (four or more times/day) testing. This criterion would preclude a Medicare beneficiary that is currently using other CGM systems, as the beneficiary would not be able to meet the “four or more times/day” testing criteria for coverage.

Recommendation: The criterion should be revised to read: “The beneficiary has been using a blood glucose monitor (BGM) as prescribed by his or her clinician, or the beneficiary has been using a continuous glucose monitor (CGM) device previous to an I-CGM.”

Rationale: Diabetes is an individualized disease that requires individualized treatment. Many individuals with insulin-dependent diabetes, both those who are current beneficiaries or those who will age into Medicare, use a traditional therapeutic CGM and may want to move to an implantable option that  better suits their diabetes management approach. As noted, such individuals would not be performing frequent (4x/day or more) testing as this is not necessary when using traditional therapeutic CGM. Further, existing guidelines focus on education and training for optimal use of CGM, rather than recommending a certain number of tests per day be performed.

Again, AdvaMed supports the direction of the proposed coverage decision, and greatly appreciates this opportunity to provide these specific comments. Don May

Thank you for your comments. Please see our response to comment number 1.

11

Latham & Watkins LLP (“Latham”) appreciates the opportunity to submit comments regarding draft Local Coverage Determination DL38686 – Implantable Continuous Glucose Monitors (“Implantable CGMs”) (the “Draft LCD”).

Latham introduced themselves and asked that WPS promptly re-evaluate the evidence submitted in connection with the Draft LCD against the applicable “reasonable and necessary” standards. A jurisdiction-wide policy establishing coverage for Implantable CGMs should not be issued unless and until there is peer-reviewed, published clinical evidence demonstrating Implantable CGMs provide a clinical benefit to Medicare beneficiaries, consistent with Medicare’s reasonable and necessary standard. Specifically, since FDA conditioned its approval on initiation of a twelve-month post-approval study comparing clinical outcomes for patients using BGM and Implantable CGMs, we believe final Medicare coverage should not be awarded until the results of this study are published.

Supporting documentation for this was included.

For the foregoing reasons, we ask that WPS delay establishing Medicare coverage for Implantable CGMs until published evidence demonstrates the ability of Implantable CGMs to improve clinical outcomes in Medicare beneficiaries with diabetes on insulin therapy. The differences in patient adherence, product design, and use between Implantable and external sensor CGM devices weigh against WPS adopting this Draft LCD that concludes Implantable CGMs will confer clinical benefits on Medicare patients.

Consistent application of the Medicare coverage criteria is critical to ensure Medicare beneficiaries receive the most appropriate items and services to diagnose and treat their clinical conditions. At this time, we do not believe the published evidence related to Implantable CGMs supports a conclusion that Implantable CGMs are reasonable and necessary for use by diabetic Medicare beneficiaries. Stuart Kurlander

Thank you for your comments. WPS respectfully disagrees with commenters and believes that evidence is sufficient to provide coverage for a therapeutic implantable continuous glucose monitor if coverage criteria are met. Although different in product design, the concept of an implantable sensor device is a reasonable and necessary option for Medicare beneficiaries as they work in partnership with their treating provider to achieve optimal control of their diabetes.

12

I am submitting comments to Medicare regarding the Local Coverage Determination for the Implantable CGM, DL38686. I am pleased that WPS developed an LCD that is favorable to implanted CGM. This will enable more patients to use this type of innovative technology.

My name is Wendy Sanders, ARNP and I specialize in the treatment and management of Diabetes and Endocrine Disorders in Cedar Rapids, Iowa for Mercy Care. I have been in practice in this area for a number of years and have an experience using Continuous Glucose Monitors (CGM) systems, including implanted CGM.

Eversense has many features that transcutaneous CGM’s do not have. These unique features make Eversense the CGM of choice for several my patients with diabetes. In the Medicare populations, having it implanted, having a transmitter that gives vibratory alerts, and having an easy to apply transmitter with a mild adhesive often makes it the only CGM that will work for specific patients. Since CGM has been proven to be such an important addition to the care of insulin-taking type 1 and type 2 patients, it is important to have choices for patients who need CGM.

I have been implanting and removing Eversense for quite some time and believe it is a necessary option for people with diabetes. The procedure is easy to do once trained and my patients tolerate this in office procedure very well.

I am also hoping you realize that since the sensor needs to be replaced every 90 days, that requiring 6-month visits is not necessary since the patients are being seen at an even greater frequency. Personally, I am hoping you will amend the 4 or more finger stick blood glucose measurements per day requirement. This is hard to document, many patients only do 3 tests per day because that is what Medicare allows, and some patients are using another CGM and not doing fingersticks any longer.

Thank you for your comments. Please see our response to comment number 1.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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