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Medtronic Insulin Pump Medicare Coverage

Exit By Johnson & Johnson Bolsters Medtronic's Insulin Pump Dominance

Exit By Johnson & Johnson Bolsters Medtronic's Insulin Pump Dominance

Using an insulin pump is an act of profound trust. Diabetic patients wear their insulin pumps at virtually all hours, relying on the medical machinery to administer doses of a potentially lethal hormone to keep their blood-sugar levels from going dangerously out of range. So it came as a shock to Ed Komp when he learned last month that his pump maker, Johnson & Johnson (JNJ), was halting all North American sales of its Animas brand insulin pumps and pushing its customers toward devices and supplies made by Medtronic. Komp had dropped Medtronic a decade ago, choosing Animas pumps instead. Now he must reconsider his options after getting the Oct. 10 letter from JNJ. “My first response was really one of fear,” said Komp, a software engineer at the University of Kansas who has used insulin pumps to treat his Type 1 diabetes for 25 years. “I’ve made the change once, and it’s a really hard change, actually. Very small differences have a big impact for me personally.” Minnesota-run Medtronic has emerged as a major winner in the $1.7 billion U.S. market for insulin pumps and supplies, as thousands of letters limiting patient choice have been sent out to diabetics, from both manufacturers and insurers. Insulin pumps typically sell for between $4,000 and $8,000 and deliver small, frequent doses of insulin day and night, which typically benefits Type 1 diabetics, whose immune systems destroy insulin-producing cells. (Type 2 diabetes, involving insulin resistance, is typically treated with manual injections, rather than a pump.) Coverage policies at UnitedHealthcare and Medicare have given Medtronic a financial edge over other insulin pump makers, and Medtronic last year scored approval for the world’s only pump system that is designed to be able to automatically self Continue reading >>

Update On Minimed 670g Availability

Update On Minimed 670g Availability

Today, I’m excited to share that we’re rolling out the MiniMed 670G system, beginning with those in the Priority Access program. But before we get into details, on behalf of the entire Medtronic team, I want to extend both my gratitude and my commitment to you. First, thank you for your enthusiasm for this new technology. We’re incredibly inspired by the many positive stories from those who’ve experienced the system (like Nicky and John) – either in the clinical trial or the initial Customer Training Phase – and from the anticipation expressed by our community. We are honored and humbled by the opportunity to contribute to a big change in your life with diabetes. Thank you also for your patience. We know the rollout of this first-of-its-kind technology is taking time. We’re doing our best to process orders and provide training as quickly as possible. However, the demand for the product surpassed even our own expectations. And we strongly believe that ensuring you have a great experience is more important than speed. With its exclusive SmartGuard HCL technology, the MiniMed 670G system takes a more active role in diabetes management than any technology that’s come before it. The system automatically adjusts basal insulin delivery throughout the day to maintain stable glucose levels. As a result, we’re seeing people spending more Time in Range and less time thinking about their diabetes, which is fantastic! But that also means it’s more critical than ever that each person who goes on the system and their healthcare team is comfortable. Even if it requires a little more time and patience from both of us. This is where our commitment comes in. Our first and foremost commitment to you is that we’ll do everything we can to ensure you have a great experie Continue reading >>

Jdrf Announces Anthem Policy Change On Medtronic Artificial Pancreas

Jdrf Announces Anthem Policy Change On Medtronic Artificial Pancreas

The Coverage2Control campaign has worked to convince payers of the value of life-saving technology and the need to control out-of-pocket costs. Anthem has changed its coverage policies to include the Medtronic MiniMed 670G, the first device to meet FDA’s definition of “artificial pancreas.” JDRF announced the policy change as a victory for its Coverage2Control campaign, which has advocated with payers to ensure choice in diabetes technology for people living with diabetes. Specifically, the Anthem update says the payer will cover the MiniMed 530G, the 630G, and the 670G. The document does not specifically address supplies related to the devices. Anthem will cover the devices only for patients with type 1 diabetes (T1D) who are age 7 or older and who have a glycated hemoglobin (A1C) value of 5.8% to 10% and for whom the device is “medically necessary.” “This is a great victory for the T1D community. By taking a tremendous step, Anthem is giving its members with diabetes access to this breakthrough in diabetes management,” said JDRF president and CEO Derek Rapp in an e-mail to The American Journal of Managed Care®. “I am so proud of how the Coverage2Control campaign helped make this happen. We applaud Anthem for this decision, and will continue to push insurers to make changes to coverage that enable better diabetes management.” Launched last spring, the JDRF campaign has 3 elements: (1) it asks health insurers to keep out-of-pocket costs for insulin, technology, and supplies “predictable and reasonable,” (2) it calls on insurers to give people the “freedom to choose the insulin pump that’s right for them,” and (3) it asks insurers to cover “all life-saving technology.” That last element became a focal point after leading insurers declined Continue reading >>

Medicare And Cgm Coverage: A New Landscape

Medicare And Cgm Coverage: A New Landscape

Background: Medicare was virtually the last large insurer not to cover CGM The type 1 diabetes community achieved a long sought and hard fought victory on January 12, 2017, when the Center for Medicare and Medicaid Services (CMS) announced that it would cover Continuous Glucose Monitoring (CGM). This came after a decision from the Food and Drug Administration (FDA) to approve the Dexcom G5 CGM system for non-adjunctive use; meaning that the Dexcom CGM is approved to directly treat blood glucose without first verifying the result with fingerstick blood glucose monitoring (BGM). While there are other requirements that also have to be met, this last, not having a non-adjunctive treatment indication from FDA, was cited as the primary reason that CMS could not cover CGM. It was stated by CMS that because CGM results required verification with another device, that its use was regarded as “precautionary,” and therefore not coverable by CMS because they did not have a category for it. Prior to FDA approval, Medicare was virtually the last major insurer in the US that would not cover a personal CGM device, no matter what the personal circumstance. This stance seemed medically indefensible, and violated the stated policies on CGM from major diabetes organizations like the American Diabetes Association (ADA), Association for Clinical Endocrinology (AACE), and Endocrine Society (ES). T1D Exchange has reported on this before to its Glu community, and some determined individuals were able to get individual coverage by struggling through multiple levels of appeal. But forcing drawn out appeals was not an acceptable solution. Driven by community need and demand Many organizations and individuals fought hard for years to change the CMS non-coverage policy, including the T1D Exchange Continue reading >>

People With Diabetes Stuck Waiting For Medicare Cgm Access

People With Diabetes Stuck Waiting For Medicare Cgm Access

We're sorry, an error occurred. We are unable to collect your feedback at this time. However, your feedback is important to us. Please try again later. Longtime type 1 Dan Patrick in Ohio is one of many people with diabetes currently in limbo, waiting for finalization of Medicare coverage of the Dexcom G5 continuous glucose monitor -- facing the uncertainly of not being able to access needed supplies for the CGM he's been using for years. He's stuck in regulatory purgatory, so to speak -- standing by while Medicare gradually rolls out a CGM coverage policy, painfully slowly and currently lacking clarity for those who need answers ASAP. "No one knows what to do right now, and that's unfortunate," Dan says. "We're all being left fending for ourselves while the bureaucrats work out the details." Dan is of course just one of scores of patients on Medicare or close to turning 65 who are facing the same concerns. While CMS's decision to cover this life-changing technology is of course a positive development that many have been advocating on for years, the practicalities of implementing it are less desirable. Yep, all those jokes about "MediScare" have turned into a reality that many don't know how to navigate. For those not hip to what's going on, here's the skinny (fraught with acronyms): Medicare hasn't traditionally covered continuous glucose monitors (CGMs), but limited case-by-case rulings by Administrative Law Judges have allowed some Medicare-covered PWDs (people with diabetes) to get access through the years. In recent years, the Centers for Medicare and Medicaid Services (CMS) has pretty much said they wouldn't cover CGM unless it was determined to be a medically necessary tool, not an "adjunctive" device that supplemented fingerstick BG (blood glucose) tests. That Continue reading >>

Diabetes Device Development Is Ramping Up But Reimbursement Looms Large

Diabetes Device Development Is Ramping Up But Reimbursement Looms Large

Diabetes device development is ramping up but reimbursement looms large Many companies are working to reduce the amount of work patients must do to manage their diabetes, but lack of CMS coverage for patch pumps may dissuade innovators from working in that space. Diabetes management has historically meant constant vigilanceincluding pricking ones finger several times a day to keep blood glucose levels in check. Diabetes device makers are looking to change this by providing them with tools that recede into the background. At least, thats what Chris Thomas, a research fellow and director of biosensor technology in Abbotts diabetes care unit, says. Abbottas well as a proliferation of other players, including medtech titan Medtronic and a number of startupsis aiming to simplify diabetes management, reducing its burden on the patient. Diabetes device development seems to have hit its stride in 2017Medtronic launched the worlds first artificial pancreas system and the FDA approved the consumer version of Abbotts mostly fingerstick-free continuous glucose monitor. Like this story? Subscribe to FierceBiotech! Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go. RELATED: Bigfoot raises $37M to trial AI-enabled insulin delivery devices The FDA is changing the way it thinks about reviewing and approving medtech. For example, the agency rolled out a program geared toward creating a more suitable regulatory path for digital health software that poses a lower risk than traditional medical devices. But, traditional device or software, regul Continue reading >>

Patients Covered By Medicare Deserve Access To Cgm:

Patients Covered By Medicare Deserve Access To Cgm:

PATIENTS COVERED BY MEDICARE DESERVE ACCESS TO CGM: By Francine Ratner Kaufman, MD LETTER FROM THE MEDTRONIC DIABETES CHIEF MEDICAL OFFICER PATIENTS COVERED BY MEDICARE DESERVE ACCESS TO CGM: WHAT WERE DOING... AND WHAT YOU CAN DO, TOO Want even more In the Know? Check out our Diabetes Educator Page for easy access to current and past articles, organized by date and topic. Over the last few years, there has been mounting evidence that continuous glucose monitoring (CGM) used in conjunction with insulin pump therapy (CSII) improves glucose outcomes1,2 and that CGM is a valuable diabetes management tool. As a result, CGM technology is recommended by national diabetes clinical guidelines .3 At the present time, an estimated 99.5% of private insurers cover CGM for qualified patients. For example, United Healthcare recently announced it would cover sensor-augmented pump (SAP) therapy for patients with type 1 or type 2 diabetes who meet specific clinical criteria that they feel can be benefited by SAP. However, Medicare does not yet cover CGM. This means those aged 65 years and greater on Medicare do not have access to this important technology. The lack of CGM access could leave these patients more vulnerable to dangerous glucose excursions, particularly hypoglycemia, potentially increasing hospitalization rates and emergency department visits. Medicare beneficiaries are being denied coverage for CGM because the Centers for Medicare and Medicaid Services (CMS) has stated that CGM technology does not meet the Medicare definition of durable medical equipmentand it currently does not fall under any other Medicare category. Medtronic Diabetes strongly believes that CSII with CGM should be available to all eligible patients, including those covered by Medicare. In addition, cove Continue reading >>

Newsflash: Medicare Can Cover Some Cgms Now!

Newsflash: Medicare Can Cover Some Cgms Now!

Huuuuge news in the Diabetes Community!!! In a surprise move late last week, the Centers for Medicare and Medicaid Services (CMS) issued a policy decision allowing for certain continuous glucose monitors (CGM) to be covered under Medicare! This important 16-page ruling on Jan. 12 came after business hours on the East Coast, and it was the JDRF -- one of the organizations that's led advocacy efforts on this issue for several years -- that put the word out right away among the D-Community. There are several reasons why this is a really big deal: CGM is a powerful therapy tool, one that can in particular save lives of people who experience hypoglycemia unawareness, or have dramatic highs and lows. SO naturally, it should be covered by insurance With Medicare refusing to cover it, patients using CGM who hit Medicare age were suddenly losing access to this important tool, which is nonsensical and frankly, unethical Classifying CGM as core therapy rather than "supplemental" paves the way not only for broader coverage of CGM across the board, but also for Artificial Pancreas systems on the near horizon What Exactly Has Changed: Up until now, CMS has considered CGM technology to be "precautionary," meaning it was classified as a supplemental type of device that wasn't medically necessary. 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. That now changes. A critical step that led to this CMS decision was the FDA's ruling in December that the Dexcom G5 specifically is accurate enough to be used for insulin dosing and treatment decisions. Thanks to that landmark FDA decision, the Medicare and Medicaid agency could now consider CGM "therapeutic" and classify it as Continue reading >>

Is My Test, Item, Or Service Covered?

Is My Test, Item, Or Service Covered?

How often is it covered? Medicare Part B (Medical Insurance) doesn’t cover insulin (unless use of an insulin pump is medically necessary), insulin pens, syringes, needles, alcohol swabs, or gauze. Medicare prescription drug coverage (Part D) may cover insulin and certain medical supplies used to inject insulin, like syringes, gauze, and alcohol swabs. If you use an external insulin pump, insulin and the pump may be covered as durable medical equipment (DME). However, suppliers of insulin pumps may not necessarily provide insulin. For more information, see durable medical equipment. Your costs in Original Medicare You pay 100% for insulin (unless used with an insulin pump, then you pay 20% of the Medicare-approved amount, and the Part B deductible applies). You pay 100% for syringes and needles, unless you have Part D. To find out how much your specific test, item, or service will cost, talk to your doctor or other health care provider. The specific amount you’ll owe may depend on several things, like: Other insurance you may have How much your doctor charges Whether your doctor accepts assignment The type of facility The location where you get your test, item, or service Continue reading >>

Medtronic Is ‘only Game In Town’ For Insulin Pumps

Medtronic Is ‘only Game In Town’ For Insulin Pumps

What is an insulin pump? An insulin pump is a small machine worn on the body for many hours at a time that can give small doses of insulin for patients whose bodies don’t make enough of the hormone naturally. Pumps cost between $4,000 and $8,000 apiece. Since they often come with a four-year warranty, insurance companies typically will only pay for one pump every four years. < Medtronic’s MiniMed 670G Using an insulin pump is an act of profound trust. Diabetic patients wear their insulin pumps at virtually all hours, relying on the medical machinery to administer doses of a potentially lethal hormone to keep their blood-sugar levels from going dangerously out of range. So it came as a shock to Ed Komp when he learned last month that his pump maker, Johnson & Johnson (JNJ), was halting all North American sales of its Animas brand insulin pumps and pushing its customers toward devices and supplies made by Medtronic. Komp had dropped Medtronic a decade ago, choosing Animas pumps instead. Now he must reconsider his options after getting the Oct. 10 letter from JNJ. “My first response was really one of fear,” said Komp, a software engineer at the University of Kansas who has used insulin pumps to treat his Type 1 diabetes for 25 years. “I’ve made the change once, and it’s a really hard change, actually. Very small differences have a big impact for me personally.” Minnesota-run Medtronic has emerged as a major winner in the $1.7 billion U.S. market for insulin pumps and supplies, as thousands of letters limiting patient choice have been sent out to diabetics, from both manufacturers and insurers. Insulin pumps typically sell for between $4,000 and $8,000 and deliver small, frequent doses of insulin day and night, which typically benefits Type 1 diabetics, whos Continue reading >>

Continuous Glucose Monitoring: Everything You Need To Know

Continuous Glucose Monitoring: Everything You Need To Know

Continuous glucose monitors or CGMs can be a lifesaving device for people with any type of diabetes. They continually check your blood sugar 24 hours a day and alert you you before you begin experiencing low or high blood sugar levels. They can reduce the number of times you have to check your blood sugar each day which is welcome news for everyone with diabetes! Insurance coverage is changing this year with Medicare jumping on board also, so this is the time to learn about this awesome piece of technology available to you. I know there are a lot of questions surrounding the use of continuous glucose monitoring, so we will break it all down here for you! What is a CGM and how does it work? Is it right for me? Will I still have to check my blood sugar? What choices do I have currently on the market? Will my insurance cover a CMG? How much will it cost? Can I travel and play sports with a CGM? In this article I will answer all your questions. What Is Continuous Glucose Monitoring (CGM)? A continuous glucose monitoring system or CGM is a system that does just what it sounds like, it monitors you glucose (blood sugar) continuously…well, every 5 minutes, 24 hours a day! You are able to see what your blood sugars are with a receiver; the data is transmitted from a sensor which is inserted right beneath your skin which is attached to a transmitter which sends the data to the receiver. Now, the newest system are even integrated with a Smartphone; with this advancement you can check your data right from your cell phone. For parents with children, this technology is peace of mind, allowing them to check their child’s blood glucose level any time-day or night. There are two different types of systems: The first is a personal continuous glucose monitoring system that you wear a Continue reading >>

Prescription Drugs - Medicare Information, Help, And Plan Enrollment - Medicare.com

Prescription Drugs - Medicare Information, Help, And Plan Enrollment - Medicare.com

Find potential savings on this prescription drug Drug information data provided by OpenFDA. OpenFDA is an initiative in the Office of Health Informatics (OHI) at the Food and Drug Administration led by the Chief Health Informatics Officer (CHIO). OpenFDA provides Application Programming Interfaces (APIs) and raw download access to a number of high-value, high priority and scalable structured datasets, including adverse events, drug product labeling, and recall enforcement reports. Privacy and Security Your privacy and security are extremely important to us. Your personal information is protected by our Privacy Policy. Our website is backed by certified internet security standards. The costs of Medicare plans are strongly regulated by the federal government. Any individual plan listed on our site carries the same costs and offers the exact same benefits regardless of whether you purchase it from our site, a government website, or your local insurance broker. Our commissions are paid by insurance carriers, so there is no additional cost to you, our consumer. Learn More To learn about Medicare plans you may be eligible for, you can: Call 1-800-MEDICARE (1-800-633-4227), TTY users 1-877-486-2048; 24 hours a day, 7 days a week. Contact a licensed insurance agency such as Medicare.com. Our licensed insurance agents are available at: Call Medicare.coms licensed sales agents: 1-844-847-2659 , TTY users 711; We are available Mon - Fri, 8am - 8pm ET Medicare.com is privately owned and operated by eHealthInsurance Services, Inc. Medicare.com is a non-government resource for those who depend on Medicare, providing Medicare information in a simple and straightforward way. If you're looking for the government's Medicare site, please navigate to www.medicare.gov . This website and it Continue reading >>

Our Decision To Switch To Medtronic Minimed 630g Insulin Pump Part 1

Our Decision To Switch To Medtronic Minimed 630g Insulin Pump Part 1

Our Decision to Switch to Medtronic Minimed 630G Insulin Pump Part 1 A few months ago, I was at home with the kids, and didnt feel quite right. After a quick fingerstick, I saw that I was in the 20s. In a panic, I couldnt get anyone on the phone to talk with me until my sugars came up. I began to eat the kitchen as it were. I finally reached my sister-in-law, who came to sit with the kids until I could get back to myself again. After that day, I was scared out of my mind to go below 100 if I was at home with the kids by myself. So, I started running my numbers highermuch higher than Im comfortable withand I knew I would be risking damage doing so. Thats when I realized, Dexcom Share wasnt enough. Its great to be able to Share and have people call to check on youbut what if they cant actuallyreachyou? My son and daughter cant use my iPhone just yet (he cant remember my unlock code), and neitherknow how to use a glucagon kit. I looked into the Loop system, but honestly, while I love that everyone is so willing to jump on board, Im not.Im not confident in my own abilities to make this thing happen since its something done from home. I dont mind tinkering and playing with Nightscout because its not directly affecting my insulin dosing, whereas the Loop system does. Thats a-okay if youre on it, Im not trying to down the system or anything. Im just not comfortable with the idea of using it myself. So, we looked into Medtronic. I know. Its known as the big evil empire of the insulin pump world. And, while I am interested in the 670G, I was more interested it the 630G since it suspends insulin if the user is low. I know this is the exact same technology as 530G, but somewhere along the way, theyve improved the CGM technology. I kept reading about how sucky the 530G was but tha Continue reading >>

Insulin Pump Therapy: Who, Why, And How

Insulin Pump Therapy: Who, Why, And How

Clinician Reviews. 2017 November;27(11):19,22-25 Alyssa Kanagaki Greenleaf practices at Baystate Endocrinology and Diabetes in Springfield, Massachusetts. The author reports no financial relationships relevant to this article. 1. American Diabetes Association. Standards of Medical Care in Diabetes2016. Diabetes Care. 2016;39(suppl 1):S1-S112. 2. American Diabetes Association. Insulin pumps. www.diabetes.org/living-with-diabetes/treatment-and-care/medication/insulin/insulin-pumps.html . Accessed October 2, 2017. 3. Aronson R, Cohen O, Conget I, et al; OpT2mis Study Group. OpT2mise: a randomized controlled trial to compare insulin pump therapy with multiple daily injections in the treatment of type 2 diabetesresearch design and methods. Diabetes Technol Ther. 2014;16:414-420. 4. Ly TT, Brnabic AJ, Eggleston A, et al. A cost-effectiveness analysis of sensor-augmented insulin pump therapy and automated insulin suspension versus standard pump therapy for hypoglycemic unaware patients with type 1 diabetes. Value Health. 2014;17(5):561-569. 5. Palinski-Wade E. Everything you need to know about insulin pumps. Diabetes Forecast. March/April 2017: Consumer Guide. www.diabetesforecast.org/2017/mar-apr/insulin-pumps-101.html . Accessed October 2, 2017. 6. Roche Diabetes Care, Inc. ACCU-CHECK Spirit Combo Users Manual (2016). www.accu-chek.com/download/file/fid/17481 . Accessed October 2, 2017. 7. Tandem Diabetes Care. t:slim Insulin Pump User Guide (2017). . Accessed October 2, 2017. 8. Medtronic. Using the Minimed 630G Insulin Pump (2016). www.medtronicdiabetes.com/sites/default/files/library/download-library/workbooks/950M15270-011.pdf . Accessed October 2, 2017. 9. Omnipod. UST400 user guide: insulin management system (2015). . Accessed October 2, 2017. 10. Animas. Diabetes tra Continue reading >>

Decision Memo For Insulin Pump: C-peptide Levels As A Criterion For Use (cag-00092r)

Decision Memo For Insulin Pump: C-peptide Levels As A Criterion For Use (cag-00092r)

To: Administrative File CAG-00092R Insulin Pump: C-Peptide Levels as a Criterion for Use From: Steve Phurrough, MD, MPA Director, Coverage and Analysis Group Marcel Salive, MD, MPH Director, Division of Medical and Surgical Services Coverage and Analysis Group Elizabeth Koller, MD Medical Officer, Division of Items and Devices Coverage and Analysis Group Lawrence Schott, MD, MS Medical Officer, Division of Medical and Surgical Services Coverage and Analysis Group CDR Betty Shaw, USPHS Health Insurance Specialist, Division of Medical and Surgical Services Coverage and Analysis Group Elizabeth Truong Health Insurance Specialist, Division of Medical and Surgical Services Coverage and Analysis Group Subject: Coverage Decision Memorandum for C-Peptide Levels as a Criterion for Use of Insulin Pumps Date: December 17, 2004 CMS has determined that the evidence is adequate to conclude that continuous subcutaneous insulin infusion (CSII) is reasonable and necessary for treatment of diabetic patients: 1) who either meet the updated fasting C-peptide testing requirement or are beta cell autoantibody positive; and 2) who satisfy the remaining criteria for insulin pump therapy detailed in the Medicare National Coverage Determinations Manual (Medicare NCD Manual 280.14, Section A.5). CMS has determined that fasting C-peptide levels will only be considered valid when a concurrently obtained fasting glucose is ≤ 225 mg/dL. Insulinopenia is defined as a fasting C-peptide level that is less than or equal to 110 percent of the lower limit of normal of the laboratory’s measurement method. Alternatively, for patients with renal insufficiency and a creatinine clearance (actual or calculated from age, gender, weight and serum creatinine) ≤ 50 ml/minute, insulinopenia is defined as a fast Continue reading >>

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