But any expansion of Medicare coverage for CGM is a positive step forward, according to authorities. But the proposed new rule would classify all CGM systems — not just “therapeutic” ones — as durable medical equipment covered by Medicare, with payment amounts established for the devices and their associated accessories and supplies. CGM also didn’t fall under the “Durable Medical Equipment” category that covers other diabetes devices and supplies, therefore it wasn’t eligible for Medicare coverage. © 2005-2020 Healthline Media a Red Ventures Company. But CGM systems are becoming increasingly popular for people with type 2 diabetes, as well. continuous glucose monitoring (CGM) systems. This is a big-ticket item, given that one-third of Medicare beneficiaries live with diabetes and more are being directed to CGM technology as a way to help manage their condition. Medicare now covers FreeStyle Libre that provides CGM or continuous glucose monitoring system in real-time. Thanks to extensive advocacy by JDRF volunteers and staff, clinician support, and strong bipartisan support from Congress, in early 2017, the Centers for Medicare & Medicaid Services (CMS) determined that continuous glucose monitoring (CGM) devices that are approved for use in treatment decisions are eligible for Medicare coverage. Sign up for our e-newsletter to receive your gift, strategies for glucose management, healthy recipes and more. According to a March 23, 2017 article from Medicare contractor CGS explaining the new coverage policy, "Coverage of the CGM system supply allowance is limited to those therapeutic CGM … Medicare has adamantly refused in the past to cover CGM sensors, receivers and transmitters claiming they are simply “convenience items” and did not qualify for coverage. So far, most CGM users with type 2 have been people who take insulin. This educational publication was produced and disseminated at U.S. taxpayer expense. CMS approved reimbursement for the FreeStyle Libre 2 (Abbott), expanding access of the integrated CGM system, or iCGM, to Medicare beneficiaries with diabetes. Be treated with insulin with multiple daily injections or a constant subcutaneous infusion (CSI) pump 4. The turning point for the Medicare coverage, he says, came with the FDA approved label change allowing consumers to make dosing decisions based on the therapeutic testing results with the CGM. When the public comment period begins, diabetes advocacy groups will most likely encourage people to participate in this process. A freelance health writer and editor based in Wisconsin, Phillips has a degree from Harvard University. — Read Medicare Advantage Plans May … As always, it’s important to triple-check the details of your own insurance plan. The beneficiary has diabetes mellitus; and, 2. In addition, Medicare coverage is available for a Read “CGM for Diabetes Management” and “How to Pick an Insulin Pump or CGM” and watch “Continuous Glucose Monitoring.”. IMPORTANT UPDATE: The Centers for Medicare & Medicaid Services (CMS) published an Interim Final Rule 1 on May 8th 2020 that they will not enforce the clinical criteria for continuous glucose monitors (CGM) during Covid19 public health emergency for Medicare patients with diabetes. Among other things, it sends a signal that new technologies are welcome. Refer to the Non-Medical Necessity Coverage and Payment Rules in the LCD-related Policy Article for additional The Centers for Medicare & Medicaid Services (CMS) proposed a new rule on October 27, 2020 that would expand coverage of important diabetes management devices. Today, under the leadership of President Trump, the Centers for Medicare & Medicaid Services (CMS), is proposing new changes to Medicare Durable Medical Equipment, Prosthetics, Orthotic Devices and Supplies (DMEPOS) coverage and payment policies. For years now, continuous glucose monitoring (CGM) systems have become a growing mainstay of diabetes management. "We are very pleased access to Eversense has been expanded to a large number of Medicare patients by these LCDs. Medicare coverage for therapeutic CGM includes certain beneficiaries who have either type 1 or type 2 diabetes and intensively manage their insulin. Coverage is subject to the specific terms of the member’s benefit plan. CGM devices covered by Medicare under the DME benefit are defined in CMS Ruling 1682R as therapeutic CGMs. Original Medicare doesn't cover If accepted, the proposed rule would classify all … This process involves soliciting comments from the public on the proposed rule, which will be considered in the agency’s final decision. Healthline Media does not provide medical advice, diagnosis, or treatment. The coverage ruling saves people between $2,500 to $4,000 a year who might otherwise purchase the equipment out of pocket. The beneficiary has been Phillips writes on a variety of topics, but is especially interested in the intersection of health and public policy. Last week, the U.S. Centers for Medicare and Medicaid Services (CMS), the federal agency that oversees Medicare, announced a proposed rule that would expand access to CGM systems under the program, as noted in an article at MedPage Today. • Committee approval date: April 21, 2020 • Accessed March 31, 2020 … 11:36 am. There are established CPT codes for providers to get paid and broad coverage within the payer community. The updated version of the company's system includes automatic alerts when the wearer's glucose is too high or too low. Thank You, Smartwatches: Monitoring Diabetes from Your Wrist, Artificial Pancreas: What You Should Know, Two New Continuous Glucose Monitors in the Works, Everything You Should Know About COVID-19 and Diabetes. 2020 Continuous Glucose Monitoring (CGM) Coding Reference and Frequently Asked Questions Refer to the chart below for billing codes for CGM. “Importantly, the proposed rule, if finalized, could enable continuity of therapy for people on certain Medtronic insulin pump systems transitioning into Medicare — including Medtronic hybrid closed loop systems which automatically adjust insulin delivery based on readings from the integrated CGM.”. Dexcom and Eversense XL CGMs, with their non-adjunctive status (no fingerstick) approval, would be the most expensive at $222.77 for the Dexcom G6 and $259.20 for the Eversense CGM supplies each month. Up until early 2017, CMS did not cover CGM use because the agency considered it to be “precautionary,” meaning CGMs were classified as a supplemental type of device that were not considered medically necessary. For some services, your PCP is required to obtain prior authorization from Aetna Medicare. Generally, you must get your health care coverage from your primary care physician (PCP). CMS admits that it really is just embracing what’s going on in the real world. Caring for a child with type 1 diabetes is hard enough, but what happens when parents separate or divorce? Additionally, the Centers for Medicare and Medicaid Additionally, CMS will not enforce Medicare’s coverage policy’s clinical indication requirements, including the requirement that beneficiaries must perform SMBG 4 or more times a day. Medicare Coverage for Libre 2 Boosts Abbott's CGM Prospects Zacks Equity Research September 03, 2020 HOLX Quick Quote HOLX QGEN Quick Quote QGEN ABT Quick Quote ABT TNDM Quick Quote TNDM “With the policies outlined in this proposed rule, innovators have a much more predictable path to understanding the kinds of products that Medicare will pay for,” CMS Administrator Seema Verma said in a statement. In addition, the elimination of some coverage … one-third of Medicare beneficiaries live with diabetes, I Tried It: Tandem’s New Control-IQ Automated Diabetes Technology, After Divorce: Tips for Co-Parenting a Child with Type 1 Diabetes, A New Home Testing Kit Can Screen for Type 1 Diabetes, How to Stay ‘Body Positive’ with Diabetes, Around the Diabetes Online Community: December 2020. Medicare and Aetna Medicare won’t be responsible either. Abbott announced yesterday that its recently cleared FreeStyle Libre 2 integrated continuous glucose monitoring (CGM) system is now covered by the Centers for Medicare and Medicaid Services (CMS), and available to Medicare beneficiaries with diabetes who meet eligibility criteria. Public comments are now being accepted, and once that comment period ends, the federal agency will work toward finalizing and publishing the precise language of the rule before it goes into effect. Medicare patients with type 1 and type 2 diabetes on intensive insulin therapy may be able to obtain reimbursement if the following Medicare coverage criteria are met: The patient has diabetes; The patient has been using a home blood glucose monitor (BGM) and … As a result of the Affordable Care Act, the coverage gap will be considered “closed” in … COVID-19 has directly impacted Medicare coverage. In the rule proposal, CMS specifically points out that several courts have disagreed with the federal agency’s standing policy stating that Medtronic’s current CGM is not being used to serve a medical purpose. Diabetes can have a big impact on your body image. The Dexcom G6 Continuous Glucose Monitoring (CGM) system is now available for eligible Medicare customers. Right now, Medicare only covers “therapeutic” CGM systems, or those that don’t require confirming a reading using a traditional finger-stick test before making treatment decisions. Type 1 diabetes advocacy organization JDRF praised this move; it’s a policy change the org has been pushing toward for years. IMPORTANT UPDATE: The Centers for Medicare & Medicaid Services (CMS) published an Interim Final Rule 1 on May 8th 2020 that they will not enforce the clinical criteria for continuous glucose monitors (CGM) during Covid19 public health emergency for Medicare patients with diabetes. Last Updated: December 7, 2020. DiabetesMine reports on future CGM devices from Ascensia Diabetes and WaveForm Diabetes, on the heels of the 2019 JP Morgan Healthcare conference. This achievement marks a … Practically speaking, the only major change would be now covering the Medtronic CGM, the only only CGM that hasn’t previously obtained the “non-adjunctive” designation that all of its competitors already have. That longstanding policy changed when the agency allowed for certain CGMs to be covered if they were deemed “therapeutic” — or cleared by the Food and Drug Administration (FDA) as accurate enough for use in treatment and dosing decisions, without a requirement for patients to take a fingerstick glucose test for confirmation. The four criteria set down by CMS, all of which must be met for coverage, include that the patient must: 1. Diabetes Self-Management offers up-to-date, practical “how-to” information on nutrition, exercise, new drugs, medical advances, self-help, and the many other topics people need to know about to stay healthy. During the COVID-19 Public Health “Broadening Medicare coverage in this way will be better able to accommodate for the future of this important technology for people with T1D.”. : After searching the Medicare Coverage Database, if no LCD/LCA is found, then use the above referenced policy.) In explaining its proposal to change the rules, the agency writes that “CGMs that are not approved for use in making diabetes treatment decisions can be used to alert beneficiaries about potentially dangerous glucose levels while they sleep,” a worthy benefit even if the person has to confirm their reading with a finger-stick test before taking corrective action. If finalized, this proposed regulation would expand Medicare coverage to all FDA-authorized continuous glucose monitors (CGMs) beginning on April 1, 2021. CGM has truly been a reimbursement success story. Medicare does not cover Dexcom G6 supplies that are only used with a smartphone or other mobile device. ABBOTT PARK, Ill., Sept. 1, 2020 /PRNewswire/ -- Abbott (NYSE: ABT), the worldwide leader in continuous glucose monitoring (CGM), 4 announced today its next-generation FreeStyle ® Libre 2 integrated continuous glucose monitoring (iCGM) system is now available to Medicare patients. The new proposed rule, if enacted, would replace the 2017 policy. The U.S. Centers for Medicare & Medicaid Services (“CMS”) reimbursement coverage has expanded the access of the Libre 2 to Medicare patients for better management of diabetes. Typically, proposed rule changes like this one end up being adopted, but they still need to go through a review process before they become official. Want to learn more about CGM? DiabetesMine has the back story on artificial pancreas technology development -- everything you need to know. Medicare covers the treatment of type 1 or type 2 diabetes that involves intensive insulin therapy with multiple injections or the use of the pump on a daily basis. Diabetes-Themed Holiday Gifts: Should You or Shouldn’t You? CGM also didn’t fall under the “durable medical equipment” category that covers other diabetes devices and supplies, therefore it wasn’t eligible for Medicare coverage. Shoppers’ Medicare supplement insurance premiums increased to $160 per month for 2021 coverage, from $157 per month for 2020 coverage. Cite this: Medicare Spells Out CGM Coverage for Diabetes - Medscape - Mar 24, 2017. Only some CGM systems meet this requirement, and they tend to be more expensive than “adjunctive” CGM systems that require a finger-stick confirmation. If finalized into policy, it would take effect in April 2021 at the earliest. Let SelectQuote compare Medicare plans and navigate the complex Medicare changes in 2020. The fact is that patients are indeed using the Medtronic Guardian 3 sensor to make treatment decisions. He is a former Editorial Assistant for Diabetes Self-Management and has years of experience covering diabetes and related health conditions. : After searching the Medicare Coverage Database, if no LCD/LCA is found, then use the above referenced policy.) Publish date: November 9, 2020. Previously, most of these devices were not covered by Medicare plans. The FreeStyle Libre 1 and Libre 2, considered “Flash Glucose Monitors” (FGM) that don’t display real-time glucose readings and require a sensor scan in order to see an actual glucose result: $46.86 for Libre 2 sensors and batteries, and $52.01 a month for the Libre 1 supplies. These include the Dexcom G5 and G6 models, the Abbott FreeStyle Libre 1 and 2, and the implantable Eversense CGM from Senseonics. That’s largely because many insurance providers, including Medicare, only cover CGM systems when they’re used to make diabetes treatment decisions, such as changing insulin doses or dietary choices. Use a home blood glucose monitor (BGM) and conduct four or more daily BGM tests 3. How do you stay positive and confident? Consult appropriate health-care professionals before taking action based on this information. Get the latest diabetes news and a free gift! If you think you might benefit from using a CGM system but don’t currently use one, talk to your doctor about the potential burdens and benefits, along with how to navigate insurance coverage — including whether it might be best to wait until the proposed Medicare rule change becomes official. 6. These devices, which take glucose readings at regular intervals using a sensor that’s worn for several days in a row, were originally popular for people with type 1 diabetes — providing a safeguard against hypoglycemia (low blood glucose) and major glucose swings. The decision was put into effect in January 2017. “Beneficiaries are continuing to use adjunctive or ‘non-therapeutic’ CGMs to help manage their diabetes, and claims submitted for this equipment and its related supplies and accessories are being denied,” the CMS proposal states. Disclaimer Statements: Statements and opinions expressed on this Web site are those of the authors and not necessarily those of the publishers or advertisers. The Centers for Medicare and Medicaid Services (CMS) announced the proposed rule change on Oct. 27, 2020, and it was published the following week in the federal register. Abbott Laboratories’ ABT next-generation FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system recently received Medicare coverage. Medicare Patients Double check that you qualify for enrollment as a Medicare patient by calling 866.779.8512, texting “Medicare CGM” to 248.577.9903, or using the checklist below.Checklist of Medicare Coverage Criteria for CGM All of the following coverage criteria must be satisfied to qualify for Medicare coverage of Therapeutic CGMs and related supplies. No doubt, the biggest issue for CGM users on Medicare will be the number of CGM sensors allotted each month, as this has been a big issue in the past, with people struggling to get coverage for the full amount they need. Additionally, CMS will not enforce Medicare’s coverage policy’s clinical indication requirements, including the requirement that beneficiaries must perform SMBG 4 or more times a day. Download the … Beneficiaries who have continuous glucose monitors (CGMs), no longer need to meet their physician face to face for CGM, testing supplies and refills in order to maintain coverage. But a recent announcement by Medicare could change that. MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION BlueCHiP for Medicare and Commercial Products Not applicable POLICY STATEMENT BlueCHiP for Medicare Continuous glucose monitoring (CGM) devices defined as “therapeutic” CGMs are covered. The U.S. Centers for Medicare & Medicaid Services (“CMS”) reimbursement coverage has expanded the access of the Libre 2 to Medicare patients for better management of … When the food and drug administration (FDA) gave the green light for people to make dosing decisions based on CGM results, Medicare began covering CGMs. Medicare covers Dexcom G6 for insulin-requiring patients who meet the Medicare coverage criteria. For the full list of Medicare coverage criteria, visit the Centers for Medicare and Medicaid services website. As such, both adjunctive and non-adjunctive CGMs would be considered Durable Medical Equipment and thus covered by Medicare. The beneficiary has diabetes mellitus (Reference the ICD-10 Codes that Support Medical Necessity section for applicable diagnoses in LCD L33822) 2. Yes. We are therefore looking forward to working with CMS on this important initiative.”. Medicare defines skilled care as care that must be performed by a skilled professional, or under their supervision This means after you and your drug plan have spent the initial coverage limit ($4,020 in 2020), you are responsible for paying a percentage of the plan’s At SelectQuote, we want to alleviate any worry or stress you might have when it comes to Medicare changes in 2020. Continuous Glucose Monitoring (CGM) CGM is proven and medically necessary for managing individuals with diabetes in the following circumstances: Short-term use (3-14 days) by a healthcare provider for diagnostic purposes. Our website services, content, and products are for informational purposes only. Your PCP will issue referrals to participating specialists and facilities for certain services. This means they did not qualify for the coveted “non-adjunctive” label required by Medicare to approve coverage. Coverage of a CGM system supply allowance (K0553) is available for those therapeutic CGM systems where the member uses a receiver classified as DME to display glucose data. All rights reserved. Official Medicare Program legal guidance is contained in the relevant statutes, regulations, and rulings. Medtronic CGM (still requiring fingerstick confirmations) would cost $198.77 per month for supplies, which factors in necessary test strips and subtracts the cost of those strips from what’s reimbursed for CGM supplies. All continuous glucose monitors (CGMs) may soon be covered by Medicare, if a new proposed federal rule is approved and takes effect. To get cutting-edge diabetes news, strategies for blood glucose management, nutrition tips, healthy recipes, and more delivered straight to your inbox, sign up for our free newsletter! A CGM system may be considered medically necessary when ONE of the following criteria are met: Individual has type 1 diabetes and is receiving short- or rapid-acting insulin therapy or Individual has type 2 diabetes and is receiving short- or rapid- acting insulin therapy or That was referred to as a “non-adjunctive” designation. The Medtronic Guardian 3 CGM may soon be covered by Medicare. Having met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & … A new proposed rule from the Centers for Medicare & Medicaid Services (CMS) would expand coverage for continuous glucose monitors (CGMs) under Medicare to include devices that aren’t approved for making treatment decisions. ICN MLN909465 September 2020 Medicare covers therapeutic CGMs and related supplies when you meet all of the following coverage criteria: 1. The explanation notes that “this proposal will improve access to these medical technologies and empower patients to make the best healthcare decisions for themselves.”, The Medicare proposal was immediately praised by the American Diabetes Association (ADA), which noted in a statement that “many of the rules limiting access for patients to CGMs are without clinical merit and limit access for patients who need them, especially lower-income Americans.”, The ADA statement notes that the group is “eager to continue to work with CMS to bring down barriers to technology access, particularly for people with diabetes who have no other way to get this important diabetes management device if their insurance will not cover it.”, The proposed rule change was also praised by the Endocrine Society, in a statement noting that “the current rules governing CGMs often result in significant burdens on both patients and physicians. Continuous Glucose Monitors Therapeutic CGMs and related supplies are covered by Medicare when all of the following coverage criteria (1-6) are met: 1. Regardless of the FDA’s view whether a product requires calibration with a fingerstick test, CMS sees the technology’s ability to alert patients to dangerous high or low glucose levels as critical — especially during sleeping hours, when patients are generally unable to do a fingerstick test. Medicare Coverage for CGMs and Other Devices Thanks to extensive advocacy by JDRF volunteers and staff, clinician support, and strong bipartisan support from Congress, in early 2017, the Centers for Medicare & Medicaid Services (CMS) determined that continuous glucose monitoring (CGM) devices that are approved for use in treatment decisions are eligible for Medicare coverage. Implantable Continuous Glucose Monitors (I-CGM) (CPT codes 0446T and 0448T) • Medicare does not have a National Coverage Determination (NCD) for implantable Medicare and CGM Coverage. DiabetesMine reviews Tandem Diabetes exciting new Control-IQ system that partially automates insulin delivery. By Quinn Phillips | Published November 9, 2020. NOTE: Therapeutic CGMs provide information that can be used to make diabetes treatment decisions, such Together these three MACs provide coverage for more than 18 states, including areas of high Medicare coverage concentration and serve approximately 20 million beneficiaries. Medicare’s current page on CGM insurance coverage states that “If you use insulin and require frequent adjustments to your insulin regimen/dosage, a CGM may be covered if your doctor determines that you meet all of the requirements for Medicare coverage.” Those requirements include not only which CGM system is being used, but the reasons why your doctor says it’s needed. “For manufacturers, bringing a new product to market will mean they can get a Medicare payment amount and billing code right off the bat, resulting in quicker access for Medicare beneficiaries to the latest technological advances and the most cutting-edge devices available.”. Most Medicare drug plans have a coverage gap, (also called a donut hole). Michael Gonzalez-Campoy, MD, Ph.D., Medical … Medicare has adamantly refused in the past to cover CGM sensors, receivers and transmitters claiming they are simply “convenience items” and did not qualify for coverage. “Medicare Coverage of Diabetes Supplies, Services, & Prevention Programs” isn’t a legal document. If you kept your existing coverage and your plan’s The information provided on this Web site should not be construed as medical instruction. “We strongly believe this proposal puts patients first and empowers them to choose the therapies that best meet their diabetes management needs,” Medtronic Diabetes lead Sean Salmon stated. A slew of smartwatches let people with diabetes monitor blood sugars from their wrist. Diabetes Self-Management offers over 900 diabetes friendly recipes to choose from including desserts, low-carb pasta dishes, savory main meals, grilled options and more. JDRF has launched T1Detect, the first-ever home screening kit for risk of type 1 diabetes. Only some CGM systems meet this requirement, and they tend to be more expensive than “adjunctive” CGM systems that require a finger-stick confirmation. January 1, 2020 New coverage begins if you made a change. Proposed Medicare rule would expand CGM coverage. Medicare and CGM Coverage When the food and drug administration (FDA) gave the green light for people to make dosing decisions based on CGM results, Medicare began covering CGMs. By Miriam E. Tucker . Medicare Coverage for Libre 2 Boosts Abbott's CGM Prospects Zacks Equity Research September 03, 2020 HOLX Quick Quote HOLX QGEN Quick Quote QGEN ABT … Blood Sugar Chart: What’s the Normal Range for Blood Sugar? At present, only those on insulin have an opportunity for approval. The coverage includes two CGM systems: Abbott’s FreeStyle Libre that provides real-time monitoring of blood glucose levels and Dexcom’s G5. Criteria. For the older adult population, Sayer says, ''the sensor is giving you a tool that the body loses. • Most plans offer extra benefits that. While Medicare would allow for coverage on any FDA-cleared CGM going forward, the pricing for Medicare members would be adjusted based on the adjunctive / non-adjuctive categorization. September 02, 2020. Dexcom now ships Dexcom … DiabetesMine shares its monthly list of favorite social media posts for December 2020. Getty . By Karena Yan Continuous glucose monitoring coverage varies widely by state Medicaid program – check out our guide on who’s covered and where In California, a staggering 25% of the population is covered under Medi-Cal (California’s Medicaid program) and the Children’s Health Insurance Program (CHIP), which are programs for low-income Americans supported by federal and state … In LCD L33822 ) 2 Spells out CGM coverage into effect in January 2017 manage their.... 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