Read “CGM for Diabetes Management” and “How to Pick an Insulin Pump or CGM” and watch “Continuous Glucose Monitoring.”. 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. A freelance health writer and editor based in Wisconsin, Phillips has a degree from Harvard University. If you kept your existing coverage and your plan’s continuous glucose monitoring (CGM) systems. 11:36 am. Blood Sugar Chart: What’s the Normal Range for Blood Sugar? This achievement marks a … 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. 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. 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. Have a diagnosis of diabetes, either type 1 or type 2 2. In addition, the elimination of some coverage … 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 … 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. If finalized, this proposed regulation would expand Medicare coverage to all FDA-authorized continuous glucose monitors (CGMs) beginning on April 1, 2021. 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. If you are on Medicare, obtaining a CGM through your healthcare professional is a relatively involved process, requiring an in-person clinic visit, lab tests, documentation of frequent finger sticks (four or more times a day), and a lot of paperwork. DiabetesMine reports on future CGM devices from Ascensia Diabetes and WaveForm Diabetes, on the heels of the 2019 JP Morgan Healthcare conference. If finalized into policy, it would take effect in April 2021 at the earliest. If accepted, the proposed rule would classify all … Our website services, content, and products are for informational purposes only. Use a home blood glucose monitor (BGM) and conduct four or more daily BGM tests 3. 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 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. 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. 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. 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. 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 … During the COVID-19 Public Health The new proposed rule, if enacted, would replace the 2017 policy. Additionally, the Centers for Medicare and Medicaid Continuous Glucose Monitors Therapeutic CGMs and related supplies are covered by Medicare when all of the following coverage criteria (1-6) are met: 1. The beneficiary has diabetes mellitus (Reference the ICD-10 Codes that Support Medical Necessity section for applicable diagnoses in LCD L33822) 2. 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. Medicare defines skilled care as care that must be performed by a skilled professional, or under their supervision 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. 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. Criteria. Diabetes can have a big impact on your body image. The coverage ruling saves people between $2,500 to $4,000 a year who might otherwise purchase the equipment out of pocket. “Medicare Coverage of Diabetes Supplies, Services, & Prevention Programs” isn’t a legal document. By Dave Muoio. 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. 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. Refer to the Non-Medical Necessity Coverage and Payment Rules in the LCD-related Policy Article for additional 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. Your PCP will issue referrals to participating specialists and facilities for certain services. Generally, you must get your health care coverage from your primary care physician (PCP). Together these three MACs provide coverage for more than 18 states, including areas of high Medicare coverage concentration and serve approximately 20 million beneficiaries. 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. All continuous glucose monitors (CGMs) may soon be covered by Medicare, if a new proposed federal rule is approved and takes effect. 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. 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. Want to learn more about CGM? DiabetesMine has the back story on artificial pancreas technology development -- everything you need to know. It’s not a guidance document. Having met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & … 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. For some services, your PCP is required to obtain prior authorization from Aetna Medicare. Caring for a child with type 1 diabetes is hard enough, but what happens when parents separate or divorce? Medicare Establishes National Payment Rate for Eversense ® CGM System Eversense CGM to be reimbursed as a Physician Service November 12, 2019 04:03 PM Eastern Standard Time 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. To date, all CGM devices on the market with the exception of those from Medtronic Diabetes are covered by Medicare. 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. Implantable Continuous Glucose Monitors (I-CGM) (CPT codes 0446T and 0448T) • Medicare does not have a National Coverage Determination (NCD) for implantable Diabetes-Themed Holiday Gifts: Should You or Shouldn’t You? JDRF has launched T1Detect, the first-ever home screening kit for risk of type 1 diabetes. Type 1 diabetes advocacy organization JDRF praised this move; it’s a policy change the org has been pushing toward for years. Publish date: November 9, 2020. This means people with diabetes covered by Medicare will have more choice in the type of diabetes technology they are able to use. January 1, 2020 New coverage begins if you made a change. Original Medicare doesn't cover The beneficiary has been With access and affordability often the biggest hurdle to achieving better health outcomes, Medicare coverage is an important topic — especially since Medicare leads the way on what policies are adopted by private health insurers. 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. When the public comment period begins, diabetes advocacy groups will most likely encourage people to participate in this process. That was referred to as a “non-adjunctive” designation. 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. Medtronic praised this new policy proposal in a statement. CGM has truly been a reimbursement success story. “CGM technology has and will continue to advance and mature, and it is important that regulations remain flexible to be able to accommodate these future advances,” said JDRF CEO Dr. Aaron Kowalski, who lives with T1D and is a long-time CGM user himself. The Centers for Medicare & Medicaid Services (CMS) proposed a new rule on October 27, 2020 that would expand coverage of important diabetes management devices. 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. coverage for 2020, if you decide to. DiabetesMine explores whether it's advisable to give someone with diabetes a holiday gift related to their disease — or rather not? 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. Dexcom now ships Dexcom … He is a former Editorial Assistant for Diabetes Self-Management and has years of experience covering diabetes and related health conditions. “Broadening Medicare coverage in this way will be better able to accommodate for the future of this important technology for people with T1D.”. The information provided on this Web site should not be construed as medical instruction. For years now, continuous glucose monitoring (CGM) systems have become a growing mainstay of diabetes management. But a recent announcement by Medicare could change that. CGM devices covered by Medicare under the DME benefit are defined in CMS Ruling 1682R as therapeutic CGMs. This process involves soliciting comments from the public on the proposed rule, which will be considered in the agency’s final decision. 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. Proposed Medicare rule would expand CGM coverage. 2020 Continuous Glucose Monitoring (CGM) Coding Reference and Frequently Asked Questions Refer to the chart below for billing codes for CGM. 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 The coverage includes two CGM systems: Abbott’s FreeStyle Libre that provides real-time monitoring of blood glucose levels and Dexcom’s G5. Medicare Coverage for CGMs and Other Devices. Coverage is subject to the specific terms of the member’s benefit plan. The Dexcom G6 Continuous Glucose Monitoring (CGM) System is covered by Medicare for patients who meet the Medicare coverage criteria. “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. 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. — Read Medicare Advantage Plans May … 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 … By Quinn Phillips | Published November 9, 2020. As a result of the Affordable Care Act, the coverage gap will be considered “closed” in … The four criteria set down by CMS, all of which must be met for coverage, include that the patient must: 1. Require frequent adjustments of the insulin treatment regimen, based on therapeutic CG… 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 The latest delivered straight to your inbox. 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. Phillips writes on a variety of topics, but is especially interested in the intersection of health and public policy. 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. CMS admits that it really is just embracing what’s going on in the real world. : After searching the Medicare Coverage Database, if no LCD/LCA is found, then use the above referenced policy.) There are established CPT codes for providers to get paid and broad coverage within the payer community. “We believe classification of CGMs in general is an important issue to address again… in rule-making.”. The Medtronic Guardian 3 CGM may soon be covered by Medicare. 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. 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. This means they did not qualify for the coveted “non-adjunctive” label required by Medicare to approve coverage. 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 … For the older adult population, Sayer says, ''the sensor is giving you a tool that the body loses. 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 cost for covered brand name and generic prescription drugs while in the coverage gap. Only some CGM systems meet this requirement, and they tend to be more expensive than “adjunctive” CGM systems that require a finger-stick confirmation. DiabetesMine reviews Tandem Diabetes exciting new Control-IQ system that partially automates insulin delivery. Additionally, the Centers for Medicare and Medicaid Services have stated that they do not meet the official definition of durable medical equipment, which keeps them falling under the DME category. Sign up for our e-newsletter to receive your gift, strategies for glucose management, healthy recipes and more. Medicare Proposes Expanding Coverage of CGMs — Would allow all continuous glucose monitors to be classified as durable medical equipment by Joyce Frieden , … Medicare Advantage members, you can request a copy of your Evidence of Coverage or Formulary if you need one. Nahezu jeder zweite Arzt in Deutschland arbeitet bereits täglich mit einem der marktführenden Arzt- und Zahnarztinformationssysteme wie CGM ALBIS , CGM M1 PRO , DATA VITAL , CGM MEDISTAR , CGM TURBOMED , CHREMASOFT und CGM Z1 . In addition, Medicare coverage is available for a Download the … However, about three months after the use of 6. 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. “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. Medicare coverage for therapeutic CGM includes certain beneficiaries who have either type 1 or type 2 diabetes and intensively manage their insulin. • Committee approval date: April 21, 2020 • Accessed March 31, 2020. Most Medicare drug plans have a coverage gap, (also called a donut hole). Yes. A year later in 2018, Medicare began also covering smartphone use with CGMs — something its previous policy change didn’t address, but left Medicare beneficiaries unable to access the latest CGM devices with smartphone connectivity as part of their core function. Michael Gonzalez-Campoy, MD, Ph.D., Medical … 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. 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. You are eligible for Medicare coverage of outpatient therapy services if: You need skilled therapy services, and the services are considered a safe and effective treatment for you. 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 Coverage for Libre 2 Boosts Abbott's CGM Prospects Zacks Equity Research September 03, 2020 HOLX Quick Quote HOLX QGEN Quick Quote QGEN ABT … 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. But any expansion of Medicare coverage for CGM is a positive step forward, according to authorities. September 02, 2020. Consult appropriate health-care professionals before taking action based on this information. NOTE: Therapeutic CGMs provide information that can be used to make diabetes treatment decisions, such Seventeen states’ Medicaid programs provide CGM for people with type 1 diabetes only: Kentucky, Louisiana, Maryland, Michigan, Mississippi, New Hampshire, New York, North Carolina, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Vermont, Wisconsin, and Wyoming. 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. The fact is that patients are indeed using the Medtronic Guardian 3 sensor to make treatment decisions. MENU News 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. “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. 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. All rights reserved. As always, it’s important to triple-check the details of your own insurance plan. How do you stay positive and confident? Medicare covers therapeutic continuous glucose monitors (CGMs) and related supplies instead of blood sugar monitors for making diabetes treatment decisions, like changes in diet and insulin dosage. DiabetesMine provides details on how to stay safe from the new coronavirus when you have diabetes. The decision was put into effect in January 2017. At SelectQuote, we want to alleviate any worry or stress you might have when it comes to Medicare changes in 2020. 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. “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.”. 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 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 … Cite this: Medicare Spells Out CGM Coverage for Diabetes - Medscape - Mar 24, 2017. Die CompuGroup Medical Deutschland AG ist eine Tochtergesellschaft der CompuGroup Medical SE & Co. KGaA, einem weltweit führenden eHealth Unternehmen. Medicare does not cover Dexcom G6 supplies that are only used with a smartphone or other mobile device. Most Medicare drug plans have a coverage gap, (also called a donut hole). But CGM systems are becoming increasingly popular for people with type 2 diabetes, as well. "We are very pleased access to Eversense has been expanded to a large number of Medicare patients by these LCDs. 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