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Post by hellodolly on Jun 28, 2021 5:27:46 GMT -5
investors.mannkindcorp.com/news-releases/news-release-details/policy-change-allows-approval-medicare-patients-living-diabetesWESTLAKE VILLAGE, Calif., June 28, 2021 /PRNewswire/ -- MannKind Corporation (Nasdaq: MNKD) appreciates the recent efforts of the Centers for Medicare and Medicaid Services (CMS) in conjunction with the Medicare Administration Contractors (MACs) to implement a policy change to the Local Coverage Determination (LCD) L33822, allowing the approval to Medicare patients living with diabetes to select both Afrezza® and Continuous Glucose Monitors (CGMs). Effective July 18, the criteria change lifts the restriction on patients of having to choose between the two diabetes tools. "Prior to this change, Medicare denials were occurring for patients using CGMs and inhaled insulin as an alternative to injected mealtime insulin," explained Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "MannKind is committed to providing convenience for patients, and believes that patients should have the choice to use any of today's tools to help manage their diabetes." MannKind requested that the Durable Medical Equipment (DME) MACs reconsider the existing language in the LCD: Glucose Monitors (L33822) to include use of inhaled insulin. Previously, the criteria defined patients as taking insulin either with multiple daily injections or an insulin pump. The amended definition now includes a patient that takes insulin with inhalation as an alternative. "This is a win-win for Medicare patients and providers that serve those patients," said Stella Ilyayeva, MD, FACE, an Endocrinology, Diabetes and Metabolism specialist. "In 2020, almost 2/3 of T1D Afrezza patients were utilizing a CGM concomitantly. I anticipate this change will open up more doors for the population of Afrezza users."
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Post by akemp3000 on Jun 28, 2021 6:38:00 GMT -5
This would explain Friday's late day surge as well as pre-market Monday. It also explains Mike's enthusiasm during the last presentation. Nicely played Mannkind. Let's hope this gets some good attention on the Wall Street ticker and moves higher. Am wondering if Cramer knew this on Friday before finally recommending MNKD as a speculative stock.
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Post by hellodolly on Jun 28, 2021 7:57:51 GMT -5
This would explain Friday's late day surge as well as pre-market Monday. It also explains Mike's enthusiasm during the last presentation. Nicely played Mannkind. Let's hope this gets some good attention on the Wall Street ticker and moves higher. Am wondering if Cramer knew this on Friday before finally recommending MNKD as a speculative stock. Good morning - Good start to the day. Russell Indexes annual rebalance showed me that they needed to add more MNKD to their holdings with the pop on Friday. Good news this morning and chatter still on WSB FB Group about MNKD also helps. |
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Post by factspls88 on Jun 28, 2021 8:18:12 GMT -5
This would explain Friday's late day surge as well as pre-market Monday. It also explains Mike's enthusiasm during the last presentation. Nicely played Mannkind. Let's hope this gets some good attention on the Wall Street ticker and moves higher. Am wondering if Cramer knew this on Friday before finally recommending MNKD as a speculative stock. Good morning - Good start to the day. Russell Indexes annual rebalance showed me that they needed to add more MNKD to their holdings with the pop on Friday. Good news this morning and chatter still on WSB FB Group about MNKD also helps. HD, Which specific WSB group are you referring to? |
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Post by cretin11 on Jun 28, 2021 9:06:10 GMT -5
This is great news that CMS has finally come around.
Sports, how do you anticipate this improving VDEX’s ability to help patients get on Afrezza? (I hope it’s ok to ask this question, though it seems obviously relevant as VDEX is one of our biggest drivers of Afrezza scripts, and this thread is about CMS approving our flagship product Afrezza.)
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Post by hellodolly on Jun 28, 2021 9:34:48 GMT -5
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Post by sayhey24 on Jun 28, 2021 9:38:18 GMT -5
I am now hoping Mike can now cut a deal with Dexcom or Abbott. Abbott is already running the T2 commercials for checking BG at meal time. Now that they know what their BG is afrezza is the only solution to allow near real time correction.
This morning's news IMO is huge news. The biggest in a long time.
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Post by lennymnkd on Jun 28, 2021 10:16:35 GMT -5
Imagine a ABBOTT / mnkd Joint add 🤔
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Post by sayhey24 on Jun 28, 2021 10:27:33 GMT -5
Imagine a ABBOTT / mnkd Joint add 🤔 I have been imagining for years. If I remember correctly wasn't it when DXCM got the medicare coverage it started its ride to the moon? afrezza is a distributive technology. Lets see if Mike can deliver. He is now one huge step closer. |
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Post by veritasfiliatemporis on Jun 28, 2021 10:31:39 GMT -5
This is going to be a lot more important than the paediatric trial... did you notice paediatric... pae come from Latin ae... just saying...pAEdriatic success will come... as usual...
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Post by radgray68 on Jun 28, 2021 10:42:17 GMT -5
Afrezza has been running a track race against behemoths. Until now, we've been running with sand in our lane and dragging an open parachute.....until now.😀
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Post by nylefty on Jun 28, 2021 10:56:50 GMT -5
This is good news, but I'm afraid it isn't quite as "huge" as some would have you believe. Private insurance companies still have the option to cover Afrezza or not in Medicare Part C or Part D plans and as of now hardly any of them do. Here's hoping that will change but there's nothing in today's announcement that will guarantee more coverage.
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Post by sr71 on Jun 28, 2021 11:06:28 GMT -5
This is good news, but I'm afraid it isn't quite as "huge" as some would have you believe. Private insurance companies still have the option to cover Afrezza or not in Medicare Part C or Part D plans and as of now hardly any of them do. Here's hoping that will change but there's nothing in today's announcement that will guarantee more coverage. Well said lefty. I sold Jul 2 5.5 and 6 calls earlier this morning using the same reasoning. |
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Post by mango on Jun 28, 2021 11:35:20 GMT -5
investors.mannkindcorp.com/news-releases/news-release-details/policy-change-allows-approval-medicare-patients-living-diabetesWESTLAKE VILLAGE, Calif., June 28, 2021 /PRNewswire/ -- MannKind Corporation (Nasdaq: MNKD) appreciates the recent efforts of the Centers for Medicare and Medicaid Services (CMS) in conjunction with the Medicare Administration Contractors (MACs) to implement a policy change to the Local Coverage Determination (LCD) L33822, allowing the approval to Medicare patients living with diabetes to select both Afrezza® and Continuous Glucose Monitors (CGMs). Effective July 18, the criteria change lifts the restriction on patients of having to choose between the two diabetes tools. " Prior to this change, Medicare denials were occurring for patients using CGMs and inhaled insulin as an alternative to injected mealtime insulin," explained Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "MannKind is committed to providing convenience for patients, and believes that patients should have the choice to use any of today's tools to help manage their diabetes." MannKind requested that the Durable Medical Equipment (DME) MACs reconsider the existing language in the LCD: Glucose Monitors (L33822) to include use of inhaled insulin. Previously, the criteria defined patients as taking insulin either with multiple daily injections or an insulin pump. The amended definition now includes a patient that takes insulin with inhalation as an alternative. "This is a win-win for Medicare patients and providers that serve those patients," said Stella Ilyayeva, MD, FACE, an Endocrinology, Diabetes and Metabolism specialist. " In 2020, almost 2/3 of T1D Afrezza patients were utilizing a CGM concomitantly. I anticipate this change will open up more doors for the population of Afrezza users." Expect to see many backlogs of Afrezza Medicare appeals released/streamlined because of this policy change. There is hundreds of thousands of pending Medicare appeals. It’s been an absolute crime against humanity that PWD have been denied Afrezza due to outlandish restrictions under Medicare for all these years. I’m sure the Insulin Cartel isn’t happy about this. |
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Post by sayhey24 on Jun 28, 2021 11:36:25 GMT -5
My understanding was those on medicare and insulin dependent could get a CGM covered but the insulin had to be an injectable. Now they can partner the CGM with afrezza and as VDex has demonstrated the CGM is a near requirement for learning initial dosing. I am sticking with my opinion this is huge news.
Maybe I am wrong but I hope not.
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