21 years ago yesterday, I was sliced and diced. I weighed 199 yesterday, which at least technically is in onederland. I never got skinny or even “normal” BMI, although I did get down to about 170-175 for a brief time. But I’m pretty healthy, all things considered, with my 71st birthday coming up in 12 days.
Today I’m seeing a local surgeon who occasionally does the DS (William Arnold), which my GI doc wanted me to do, to address the nausea I get somewhat frequently, which often causes me to wake up in the middle of the night and puke (mostly spit and dry heaving - my stomach is almost always very empty when this happens). I’ve had every sort of test - EGD, MRI, swallow tests (I also choke occasionally - I really don’t enjoy taking my horse pills twice/day, but I do), and multiple types of PPIs, twice the usual dose.
I also have worn a CGM for two weeks recently, since we accidentally and unnecessarily bought a second starter Freestyle Libre 3 set when Charles picked up a large expensive order at the pharmacy without looking in the bag (the doc’s assistant sent the order to the pharmacy rather than our Medicare provider) - I was hoping to confirm my suspicion that my middle of the night nausea was from low blood sugar, but (good news/bad news) my blood sugar is rock steady - never dipped below 80 or went above 150, even when I tried eating a mess of SweetTarts to see if that would cause a high and/or a rebound low. Nope. It was in the low 100s when I puked in the middle of the night during that trial.
I do, however, have a(nother) mild hiatal hernia, and the GI doc wants a bariatric surgeon to evaluate.
But I think I’m also going to see if he’s willing to consider prescribing a GLP-1 agonist in a way that Medicare might cover it next year.
The FDA has approved and at least some Medicare Part D plans should cover Wegovy (which is for weight loss) when there is both obesity and some sort of cardiovascular risk. I suspect I will still not qualify, as my CV risk is the usual moderate plaque accumulation, but some of you may be interested in this information, and what the bariatric surgeon says.
This is the text of the CMS memo, but it doesn’t solve or provide any real direction for what is meant by “established cardiovascular disease.”
~~~
HPMS E-Mail
Date: March 20, 2024
Subject: Part D Coverage of Anti-Obesity Medications with Medically Accepted Indications
We are issuing this guidance regarding Medicare Part D coverage of chronic weight management products, also known as anti-obesity medications (AOMs). With the introduction of new AOMs to the market, questions have arisen regarding Part D coverage of these products. Specifically, we have been asked whether these products may be covered by Part D when they receive U.S. Food and Drug Administration (FDA) approval for an additional medically accepted indication.
The statutory definition of a covered Part D drug at section 1860D-2(e)(2) of the Social Security Act (the Act), excludes certain drugs and uses – specifically, those that may be excluded by Medicaid under section 1927(d)(2) of the Act. This includes “agents when used for anorexia, weight loss, and weight gain. Since the beginning of the Part D program in 2006, all drugs when used for weight loss have been excluded from basic coverage.
CMS is clarifying that AOMs that receive FDA approval for an additional medically accepted indication, as defined by section 1927(k)(6) of the Act, can be considered a Part D drug for that
specific use. For example, a glucagon-like peptide 1 (GLP-1) receptor agonist that receives FDA approval for chronic weight management alone would not be considered a Part D drug. If this same drug also receives FDA approval to treat diabetes or reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight, then it would be considered a Part D drug for those specific uses only. Unless provided as a supplemental benefit, Part D coverage is still not available for AOMs when used for chronic weight management in patients who do not have the additional medically accepted indication.
In instances when an AOM receives approval for an additional medically accepted indication during the contract year, Part D sponsors may include such drugs on their current Part D formularies as they can be covered under Part D for that use. These drugs will be added to the Formulary Reference File (FRF) at the next available opportunity. Utilization management tools such as prior authorization, step therapy, and quantity limits that are approved by the Pharmacy
& Therapeutics committee may be applied at the point-of-sale at the same time the drug is added to the formulary. Part D sponsors may consider using prior authorization for these products to
ensure they are being used for a medically accepted indication. When an AOM receives approval for an additional medically accepted indication mid-year, CMS will evaluate FDA labeling and updated treatment guidelines (if available) when reviewing formularies for the upcoming year.
If you have any questions concerning this memorandum, please send an e-mail to [email protected].
~~~~
According to this (https://www.ncbi.nlm.nih.gov/books/NBK535419), cardiovascular disease is defined as follows:
“Cardiovascular disease, also known as heart disease, refers to the following 4 entities: coronary artery disease (CAD) which is also referred to as coronary heart disease (CHD), cerebrovascular disease, peripheral artery disease (PAD), and aortic atherosclerosis.”
This still doesn’t help me - what exactly is CAD? What is aortic atherosclerosis?
The article includes this, in the description of a figure:
Coronary Artery Disease Pathophysiology. Coronary artery disease is usually caused by an atherosclerotic plaque that blocks the lumen of a coronary artery, typically the left anterior descending artery.
So lucky for me, whatever is wrong with me doesn’t require intervention at this time, per my cardiologist, and my PCP recently put me on Crestor prophylactically (well, my LDLs were also high). The calcium study I had done indicated:
~~~~
The patient's coronary calcium score is 93. This places the patient between 50th and 75th percentile for an age and gender matched cohort.
Left Main: 58
Right Coronary: 0
Left Anterior Descending: 31
Circumflex: 4
Misc: 0
…
GENERAL FINDINGS:
Mild diffuse hepatic parenchymal steatosis.
No pneumonia.
Hiatal hernia.
Postsurgical changes of sleeve gastrectomy/prior bariatric surgery.
Atherosclerotic vascular calcification.
…
IMPRESSION:
1. Coronary artery calcium score of 93, as described above.
Calcium score: 11-100
Implication: Definite, at least mild atherosclerotic plaque
Risk of CAD: Mild or minimal coronary narrowings likely.
…
[At the same time, I had a scan for lung cancer as a former smoker]
FINDINGS:
The lungs are clear without suspicious pulmonary mass or nodules.
No emphysematous changes are seen.
No air trapping is visible.
No interstitial changes are seen.
No thoracic aortic aneurysm is identified after accounting for pulsation artifact.
No pericardial effusion is seen.
Coronary artery calcification. ****
~~~~~
And in my medical records with my PCP, after my recent yearly exam, I have a new diagnosis of coronary atherosclerosis.
BUT I DON’T KNOW WHAT RULES MEDICARE PART D PROVIDERS WILL APPLY FOR THE DEFINITION OF QUALIFYING CARDIOVASCULAR DISEASE.
In the clinical trial, patients had to have the following:
“Have established cardiovascular (CV) disease as evidenced by at least one of the following:
• prior myocardial infarction;
• prior stroke (ischemic or haemorrhagic stroke); or
• symptomatic peripheral arterial disease (PAD), as evidenced by
• intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or
• peripheral arterial revascularization procedure, or
• amputation due to atherosclerotic disease”
Fortunately I have had none of these, knock wood. But I suspect that the Medicare Part D providers will likely require the same conditions to qualify for coverage. I’m assuming or at least hoping this will be disclosed in the upcoming Part D open enrollment disclosures at Medicare.gov in October.
Here is a good summary of the announcement:
~~~~~
Later:
So at the doctor’s appointment, I saw his intern or resident (?), who talked to me and then left to discuss with Arnold, who was in a meeting (?) 2 or 3 times.
First we discussed the barfing and the reason the GI doc wanted me to see him. I made it clear I was not looking for a sleeve revision, as I still have good restriction (some sleeve people I’m sure you know use GERD as an excuse to get a revision), but only if necessary and not for the purpose of additional weight loss - a sleeve tightening would make me miserable.
I also asked about Wegovy in view of my possibly qualifying based on my admittedly currently mild cardiovascular disease. He gave me the recitation of the negatives, including having to take it the rest of my life (no problem), increased nausea (but I pointed out that since my stomach empties very quickly, the gastroparesis might be HELPFUL), and pancreatitis concerns.
The bottom line is that they are first going to do a bunch of tests to see if they can figure out what is causing my nausea. EGD (last one was in October 2022, so I’m actually due), some kind of swallow study, and something’s about a pH test that sounded ominous.
I asked what they were looking for that might be treatable - one possibility is surgery to fix the hiatal hernia. We discussed whether I was willing to have surgery, and I said I’d really need to be convinced that I need it. I’d rather barf in the middle of the night a few times a month. But if it’s going to get worse as I get older, better to fix it now when I’m “only” 71 and in reasonably good health.
He didn’t say anything else, so I asked what else they might find that is treatable without surgery, and he said if they found that I had gastric (or maybe esophageal?) hypermotility it could be treated.
I asked how, and he smiled and said “with Wegovy.”
Today I’m seeing a local surgeon who occasionally does the DS (William Arnold), which my GI doc wanted me to do, to address the nausea I get somewhat frequently, which often causes me to wake up in the middle of the night and puke (mostly spit and dry heaving - my stomach is almost always very empty when this happens). I’ve had every sort of test - EGD, MRI, swallow tests (I also choke occasionally - I really don’t enjoy taking my horse pills twice/day, but I do), and multiple types of PPIs, twice the usual dose.
I also have worn a CGM for two weeks recently, since we accidentally and unnecessarily bought a second starter Freestyle Libre 3 set when Charles picked up a large expensive order at the pharmacy without looking in the bag (the doc’s assistant sent the order to the pharmacy rather than our Medicare provider) - I was hoping to confirm my suspicion that my middle of the night nausea was from low blood sugar, but (good news/bad news) my blood sugar is rock steady - never dipped below 80 or went above 150, even when I tried eating a mess of SweetTarts to see if that would cause a high and/or a rebound low. Nope. It was in the low 100s when I puked in the middle of the night during that trial.
I do, however, have a(nother) mild hiatal hernia, and the GI doc wants a bariatric surgeon to evaluate.
But I think I’m also going to see if he’s willing to consider prescribing a GLP-1 agonist in a way that Medicare might cover it next year.
The FDA has approved and at least some Medicare Part D plans should cover Wegovy (which is for weight loss) when there is both obesity and some sort of cardiovascular risk. I suspect I will still not qualify, as my CV risk is the usual moderate plaque accumulation, but some of you may be interested in this information, and what the bariatric surgeon says.
This is the text of the CMS memo, but it doesn’t solve or provide any real direction for what is meant by “established cardiovascular disease.”
~~~
HPMS E-Mail
Date: March 20, 2024
Subject: Part D Coverage of Anti-Obesity Medications with Medically Accepted Indications
We are issuing this guidance regarding Medicare Part D coverage of chronic weight management products, also known as anti-obesity medications (AOMs). With the introduction of new AOMs to the market, questions have arisen regarding Part D coverage of these products. Specifically, we have been asked whether these products may be covered by Part D when they receive U.S. Food and Drug Administration (FDA) approval for an additional medically accepted indication.
The statutory definition of a covered Part D drug at section 1860D-2(e)(2) of the Social Security Act (the Act), excludes certain drugs and uses – specifically, those that may be excluded by Medicaid under section 1927(d)(2) of the Act. This includes “agents when used for anorexia, weight loss, and weight gain. Since the beginning of the Part D program in 2006, all drugs when used for weight loss have been excluded from basic coverage.
CMS is clarifying that AOMs that receive FDA approval for an additional medically accepted indication, as defined by section 1927(k)(6) of the Act, can be considered a Part D drug for that
specific use. For example, a glucagon-like peptide 1 (GLP-1) receptor agonist that receives FDA approval for chronic weight management alone would not be considered a Part D drug. If this same drug also receives FDA approval to treat diabetes or reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight, then it would be considered a Part D drug for those specific uses only. Unless provided as a supplemental benefit, Part D coverage is still not available for AOMs when used for chronic weight management in patients who do not have the additional medically accepted indication.
In instances when an AOM receives approval for an additional medically accepted indication during the contract year, Part D sponsors may include such drugs on their current Part D formularies as they can be covered under Part D for that use. These drugs will be added to the Formulary Reference File (FRF) at the next available opportunity. Utilization management tools such as prior authorization, step therapy, and quantity limits that are approved by the Pharmacy
& Therapeutics committee may be applied at the point-of-sale at the same time the drug is added to the formulary. Part D sponsors may consider using prior authorization for these products to
ensure they are being used for a medically accepted indication. When an AOM receives approval for an additional medically accepted indication mid-year, CMS will evaluate FDA labeling and updated treatment guidelines (if available) when reviewing formularies for the upcoming year.
If you have any questions concerning this memorandum, please send an e-mail to [email protected].
~~~~
According to this (https://www.ncbi.nlm.nih.gov/books/NBK535419), cardiovascular disease is defined as follows:
“Cardiovascular disease, also known as heart disease, refers to the following 4 entities: coronary artery disease (CAD) which is also referred to as coronary heart disease (CHD), cerebrovascular disease, peripheral artery disease (PAD), and aortic atherosclerosis.”
This still doesn’t help me - what exactly is CAD? What is aortic atherosclerosis?
The article includes this, in the description of a figure:
Coronary Artery Disease Pathophysiology. Coronary artery disease is usually caused by an atherosclerotic plaque that blocks the lumen of a coronary artery, typically the left anterior descending artery.
So lucky for me, whatever is wrong with me doesn’t require intervention at this time, per my cardiologist, and my PCP recently put me on Crestor prophylactically (well, my LDLs were also high). The calcium study I had done indicated:
~~~~
The patient's coronary calcium score is 93. This places the patient between 50th and 75th percentile for an age and gender matched cohort.
Left Main: 58
Right Coronary: 0
Left Anterior Descending: 31
Circumflex: 4
Misc: 0
…
GENERAL FINDINGS:
Mild diffuse hepatic parenchymal steatosis.
No pneumonia.
Hiatal hernia.
Postsurgical changes of sleeve gastrectomy/prior bariatric surgery.
Atherosclerotic vascular calcification.
…
IMPRESSION:
1. Coronary artery calcium score of 93, as described above.
Calcium score: 11-100
Implication: Definite, at least mild atherosclerotic plaque
Risk of CAD: Mild or minimal coronary narrowings likely.
…
[At the same time, I had a scan for lung cancer as a former smoker]
FINDINGS:
The lungs are clear without suspicious pulmonary mass or nodules.
No emphysematous changes are seen.
No air trapping is visible.
No interstitial changes are seen.
No thoracic aortic aneurysm is identified after accounting for pulsation artifact.
No pericardial effusion is seen.
Coronary artery calcification. ****
~~~~~
And in my medical records with my PCP, after my recent yearly exam, I have a new diagnosis of coronary atherosclerosis.
BUT I DON’T KNOW WHAT RULES MEDICARE PART D PROVIDERS WILL APPLY FOR THE DEFINITION OF QUALIFYING CARDIOVASCULAR DISEASE.
In the clinical trial, patients had to have the following:
“Have established cardiovascular (CV) disease as evidenced by at least one of the following:
• prior myocardial infarction;
• prior stroke (ischemic or haemorrhagic stroke); or
• symptomatic peripheral arterial disease (PAD), as evidenced by
• intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or
• peripheral arterial revascularization procedure, or
• amputation due to atherosclerotic disease”
Fortunately I have had none of these, knock wood. But I suspect that the Medicare Part D providers will likely require the same conditions to qualify for coverage. I’m assuming or at least hoping this will be disclosed in the upcoming Part D open enrollment disclosures at Medicare.gov in October.
Here is a good summary of the announcement:
~~~~~
Later:
So at the doctor’s appointment, I saw his intern or resident (?), who talked to me and then left to discuss with Arnold, who was in a meeting (?) 2 or 3 times.
First we discussed the barfing and the reason the GI doc wanted me to see him. I made it clear I was not looking for a sleeve revision, as I still have good restriction (some sleeve people I’m sure you know use GERD as an excuse to get a revision), but only if necessary and not for the purpose of additional weight loss - a sleeve tightening would make me miserable.
I also asked about Wegovy in view of my possibly qualifying based on my admittedly currently mild cardiovascular disease. He gave me the recitation of the negatives, including having to take it the rest of my life (no problem), increased nausea (but I pointed out that since my stomach empties very quickly, the gastroparesis might be HELPFUL), and pancreatitis concerns.
The bottom line is that they are first going to do a bunch of tests to see if they can figure out what is causing my nausea. EGD (last one was in October 2022, so I’m actually due), some kind of swallow study, and something’s about a pH test that sounded ominous.
I asked what they were looking for that might be treatable - one possibility is surgery to fix the hiatal hernia. We discussed whether I was willing to have surgery, and I said I’d really need to be convinced that I need it. I’d rather barf in the middle of the night a few times a month. But if it’s going to get worse as I get older, better to fix it now when I’m “only” 71 and in reasonably good health.
He didn’t say anything else, so I asked what else they might find that is treatable without surgery, and he said if they found that I had gastric (or maybe esophageal?) hypermotility it could be treated.
I asked how, and he smiled and said “with Wegovy.”
