Medicare Advantage Tied to Less Use of Pricey Diabetes Drugs

https://www.medscape.com/viewarticle/977181

US Medicare beneficiaries with type 2 diabetes who had health coverage through a Medicare Advantage (MA) plan received treatment with an SGLT2 inhibitor or GLP-1 receptor agonist significantly less often than patients with traditional fee-for-service (FFS) Medicare coverage in 2014-2019, according to a study of more than 411,000 patients.

“MA beneficiaries had modestly but significantly poorer intermediate health outcomes and were less likely to be treated with newer evidence-based antihyperglycemic therapies compared with Medicare FFS beneficiaries,” conclude Utibe R. Essien, MD, and coauthors in a study published July 6 in Diabetes Care.

The report comes as the US Congress is looking closely at the MA program and evidence that insurance companies that provide these policies sometimes impose inappropriate barriers on enrolled beneficiaries by denying or limiting access to treatments and interventions in ways that run counter to Medicare’s coverage policies.

According to Representative Diana DeGette (D-CO), who chaired a hearing on MA plans on June 28 by the House of Representatives’ Energy and Commerce Subcommittee on Oversight and Investigations, beneficiaries who are covered through an MA plan “do not always get the care that they are entitled to.”

The study by Essien and colleagues also documents some positives of care delivered through MA plans for patients with type 2 diabetes compared with what FFS Medicare beneficiaries generally receive, such as significantly higher rates of screening for nephropathy and ophthalmologic disorders, and foot examinations.

But the apparently dampened use of sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists among MA beneficiaries stand out as notable shortcomings, Essien maintained.

Cost Containment May Limit Use

“The differences in health outcomes and in treatments in MA plans are important to highlight,” Essien said in an interview. “We worry that the cost-containment challenges [associated with MA plans] may be limiting use of these newer treatments.”

The study was based on 2014-2019 data from the Diabetes Collaborative Registry, which collects information from more than 5000 US clinicians whose practices include patients with diabetes, as well as claims data recorded by the Centers for Medicare and Medicaid Services during 2014-2017.

The main analysis focused on 345,911 Medicare beneficiaries ≤ 75 years old with diabetes, which included 34% with MA coverage and 66% with FFS coverage. The two subgroups had similar ages, about 75 years old, and roughly half were women in both subgroups. The rate at which both subgroups received statin treatment was nearly the same: 72% for those with MA coverage and 71% for those with FFS Medicare.

But MA beneficiaries differed from those with FFS coverage in several other ways. MA beneficiaries had a higher prevalence of Medicaid eligibility than the FFS group (20% vs 12%) and lower rates of consultations with cardiologists (41% vs 45%) or endocrinologists (7% vs 10%).

Some of the positive differences in the care received by MA beneficiaries compared with FFS beneficiaries, after adjustment for potential clinical and sociodemographic confounders, included:

• Screening for nephropathy, at a significant 14% higher relative rate.
• Screening for ophthalmologic disorders, at a significant 8% higher relative rate.
• Undergoing a diabetic foot examination, at a significant 13% higher relative rate.
• Receiving smoking-cessation counseling, at a significant 5% higher relative rate.
• Receiving treatment with an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker (87% vs 81%).
• More consistently receiving treatment with metformin, with rates of 72% versus 69% in 2017.

However, these positive differences were accompanied by these relative shortcomings for those with MA compared with FFS coverage:

• Lower rates of treatment with an SGLT2 inhibitor (5.4% vs 6.7%), a significant 9% relative difference after adjustment.
• Lower rates of treatment with a GLP-1 agonist (6.9% vs 9.0%), a significant 20% relative difference after adjustment.
• Higher average levels of low-density lipoprotein cholesterol (81.5 vs 78.9 mg/dL), a significantly higher average A1c level (7.1% vs 7.0%), and a trend toward a lower prevalence of blood pressure control (70.3% vs 71.5%).

Researchers also highlight that the lower rate at which people with MA coverage received SGLT2 inhibitors or GLP-1 agonists was consistent in patients with established cardiovascular or kidney disease, for whom these agents are particularly recommended.

In addition, a secondary analysis of data for another 65,000 Medicare beneficiaries in 2018 and 2019 showed the disparity in use of agents from these two drug classes continued.

Low Systemic Use of SGLT2 Inhibitors, GLP-1 Agonists

Essien acknowledged that, even in people with FFS Medicare coverage, use of SGLT2 inhibitors and GLP-1 agonists was low, but the difference between those with MA coverage is “important,” he stressed.

Researchers offered four factors that might drive reduced prescribing of agents from these two classes for patients with type 2 diabetes with MA coverage: cost-containment strategies put in place by MA plans; the lower rate of consultations with specialists (cardiologists and endocrinologists); possible exclusion of clinicians from MA provider networks who tend to prescribe these higher-price agents; and lower household incomes of people with MA plans, which may lead to cost-related nonadherence.

Most SGLT2 inhibitors have an average retail cost of about $6,000/year, and some GLP-1 agonists cost more than $10,000/year.

In general, MA coverage includes more oversight of care and its cost than occurs with FFS coverage, noted Essien, an internal medicine physician at the University of Pittsburgh and a researcher at the Center for Health Equity Research and Promotion of the VA Pittsburgh Healthcare System, Pennsylvania.

“Incentives for using these more expensive treatments may not be there in MA plans,” he explained. Overcoming cost-related barriers is a challenge that will require “bold policy changes,” as well as better education of clinicians so they make correct treatment decisions, and of patients to resolve possible concerns about treatment safety.

Representative DeGette hinted during her remarks at the June hearing that policy changes may be coming from Congress.

“Our seniors and their doctors should not be required to jump through numerous hoops to get coverage for straightforward and medically necessary procedures,” she said.

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U.S. Public Health Agencies Aren’t ‘Following the Science,’ Officials Say

‘People are getting bad advice and we can’t say anything.’

https://www.commonsense.news/p/us-public-health-agencies-arent-following

The calls and text messages are relentless. On the other end are doctors and scientists at the top levels of the NIH, FDA and CDC. They are variously frustrated, exasperated and alarmed about the direction of the agencies to which they have devoted their careers.

“It’s like a horror movie I’m being forced to watch and I can’t close my eyes,” one senior FDA official lamented. “People are getting bad advice and we can’t say anything.”

That particular FDA doctor was referring to two recent developments inside the agency. First, how, with no solid clinical data, the agency authorized Covid vaccines for infants and toddlers, including those who already had Covid. And second, the fact that just months before, the FDA bypassed their external experts to authorize booster shots for young children.

That doctor is hardly alone.

At the NIH, doctors and scientists complain to us about low morale and lower staffing: The NIH’s Vaccine Research Center has had many of its senior scientists leave over the last year, including the director, deputy director and chief medical officer. “They have no leadership right now. Suddenly there’s an enormous number of jobs opening up at the highest level positions,” one NIH scientist told us. (The people who spoke to us would only agree to be quoted anonymously, citing fear of professional repercussions.) 

The CDC has experienced a similar exodus. “There’s been a large amount of turnover. Morale is low,” one high level official at the CDC told us. “Things have become so political, so what are we there for?” Another CDC scientist told us: “I used to be proud to tell people I work at the CDC. Now I’m embarrassed.”

Why are they embarrassed? In short, bad science. 

The longer answer: that the heads of their agencies are using weak or flawed data to make critically important public health decisions. That such decisions are being driven by what’s politically palatable to people in Washington or to the Biden administration. And that they have a myopic focus on one virus instead of overall health.

Nowhere has this problem been clearer—or the stakes higher—than on official public health policy regarding children and Covid. 

First, they demanded that young children be masked in schools. On this score, the agencies were wrong. Compelling studies later found schools that masked children had no different rates of transmission. And for social and linguistic development, children need to see the faces of others. 

Next came school closures. The agencies were wrong—and catastrophically so. Poor and minority children suffered learning loss with an 11-point drop in math scores alone and a 20% drop in math pass rates. There are dozens of statistics of this kind.

Then they ignored natural immunity. Wrong again. The vast majority of children have already had Covid, but this has made no difference in the blanket mandates for childhood vaccines. And now, by mandating vaccines and boosters for young healthy people, with no strong supporting data, these agencies are only further eroding public trust.

One CDC scientist told us about her shame and frustration about what happened to American children during the pandemic: “CDC failed to balance the risks of Covid with other risks that come from closing schools,” she said. “Learning loss, mental health exacerbations were obvious early on and those worsened as the guidance insisted on keeping schools virtual. CDC guidance worsened racial equity for generations to come. It failed this generation of children.”

An official at the FDA put it this way: “I can’t tell you how many people at the FDA have told me, ‘I don’t like any of this, but I just need to make it to my retirement.’”

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Supreme Court Tells Cops To Stop Playing Doctor

https://www.acsh.org/news/2022/07/15/supreme-court-tells-cops-stop-playing-doctor-16434

Image credit: Wikimedia Commons

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Express Scripts Sued by AIDS Healthcare Foundation (AHF) Over ‘Claw Backs’

https://www.aidshealth.org/2022/07/express-scripts-sued-by-ahf-over-claw-backs/

Sweeping federal lawsuit, asserting 14 claims of violations of law in nine U.S. states where AHF operates pharmacies, was filed in federal court in St. Louis, MO

 AHF asserts Express Scripts, a huge pharmacy benefits manager, manipulates loophole in Medicare “Star Ratings” system as purported justification for “clawing back” millions of dollars of Medicare benefits from AHF pharmacies, creating higher profits for Express Scripts at the expense of patients

LOS ANGELES (July 13, 2022) AIDS Healthcare Foundation (AHF), the largest global AIDS organization, which cares for over 100,000 individuals living with HIV or AIDS in the United States, filed a lawsuit in the U.S. District Court for the Eastern District of Missouri, Eastern Division, against Express Scripts, one of the three dominant U.S. pharmacy benefits managers (PBMs), and a subsidiary of Cigna, the $47-billion global health-insurance behemoth. The case, AIDS Healthcare Foundation v. Express Scripts, Inc. (Case No. 4:22-cv-00743), was filed yesterday.

AHF is the owner of the “AHF Pharmacy” chain of pharmacies, serving primarily people of limited economic means living with HIV/AIDS. Because Express Scripts manages pharmacy benefits for – and effectively controls access to – tens of millions of people with health insurance in the United States, Express Scripts has much greater bargaining power than much smaller community and specialty pharmacies like AHF’s (even in small chains).  Express Scripts offers AHF and other pharmacies essentially “take-it-or-leave-it” contracts with terms and conditions excessively favorable to Express Scripts and deleterious to AHF.  Pharmacies like AHF must accept these contracts or lose access to countless patients.

Specifically, AHF asserts that Express Scripts manipulates the Medicare “Star Ratings” system – which are used to score insurance plans – to give unfairly low “performance” scores to participating pharmacies, and that, as a result of these arbitrary low scores, the PBM then ‘claws back’ Medicare benefits from pharmacies—often months and years after the fact—actions that result in higher profits for Express Scripts at the expense of HIV/AIDS and other patients served by AHF and other independent and mom-and-pop pharmacies.

“AHF brought this civil action to recover many millions of dollars taken by Express Scripts, purportedly pursuant to unconscionable contracts with AHF yet in violation of those very contracts and the covenant of good faith and fair dealing implied in those contracts, among other violations of AHF’s rights,” said Andrew F. Kim, AHF’s lead counsel on the matter.

AHF asserts 14 counts of Express Scripts law violations in nine U.S. states where AHF operates pharmacies. Among the counts are “unfair” or “deceptive” trade or business practices in California, Florida, Louisiana, New York, and Washington state.  Five other counts assert violations of “any willing provider” laws in Georgia, Illinois, Louisiana, Mississippi, and South Carolina.

AHF is demanding a jury trial in the case, which was filed by AHF in-house counsel and Kim Riley Law.

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Hi Steve,

I came across your website and noticed you had your email listed. A pharmacist refused to fill a controlled substance for me after speaking with my physician from a nationally renowned clinic in the US. I was not provided a concrete reason, other than pharmacists have the right to not dispense. However, it is a legal script from a legal institution. I’m covered under ADA since I have PTSD and I was accused (loosely) of putting their business at risk due to addiction concerns. I’m not an addict, but my report has a lot of medications because it takes a lot of trial and error for mental health patients to find the correct medications. Anyway, it seemed like her personal opinion. I then contacted the Costco manager and they said I don’t have a right to her last name to file a formal complaint against her license. My husband called and corrected them and received her name. Any insight you have into this would be appreciated, such as is this an ADA violation? Can a pharmacist defend not filling a legal script? There are no other medication interactions.

Thank you,

Pharmacists have a few very valid clinical reasons for postponing the filling of a Rx. Level one Drug to Drug interaction, drug -disease contraindication, dose potentially lethal. . until the prescriber was contacted and my concerns were validated and the prescriber confirmed that is what he/she wanted or the med was changed..   If the prescriber told me to dispense as written… I would document the conversation and have a conversation with the pt of my concerns and ask if they wanted me to fill it.. If they wanted me to fill it, I would advise them of what side effects that they should be on the look out for.  If the Rx was forged or altered… I tried my best to get the person a free ride downtown..  and when that happened I typically would get a 12-18 month respite of anyone trying to pass a forged Rx on me.

Somewhere along the line, Pharmacists seem to have forgotten that refusing the filling a Rx is permissible for ANY VALID CLINICAL REASON.  Personal opinions, biases or phobias are not clinical reasons.

One of the basics of the practice of medicine is starting, changing, stopping a pt’s therapy..  IMO, a Pharmacist refusing to fill a Rx without some valid clinical reason… is in a pretty fuzzy area, no trying to resolve or adjudicate any clinical or therapeutic concerns with the prescriber… is shirking their professional responsibilities.

In reality, all addictions typically have a substantial underlying mental health issues… most all undiagnosed and untreated… and the addict is mostly self medicating to silence the demons in their head and/or monkeys on their back that they did not know they were there and their drug(s) of choice silenced them… and they end up going down a pretty rough path.  So, from what you said, it would appear that Costco does not want to fill prescriptions for people dealing with mental health issues ?

At one time, I was Pharmacist in charge of the 2nd largest out pt mental health company in the country, in house pharmacy.  I may have a better understanding of mental health issues than the average pharmacist.

IMO, you were profiled and discriminated against because of your necessary medication, and was probably a violation of ADA and Civil Rights Act… but… getting any bureaucratic entity that should enforce those laws… won’t do so on a single incident. Will claim they don’t have the resources to pursue your issue.

My suggestion is to take your Rx business to a local independent pharmacy, where you will be dealing with the Pharmacist/owner.  I had my own independent pharmacy for 20 yrs and rubbed elbow with these pharmacist at state & national association meetings.. The mindset is 180 degrees from your typical  employee chain pharmacist…  They are there to take care of all pts, not pass judgement on pts.  Here is a link to find some independent pharmacy by zip code & radius https://ncpa.org/pharmacy-locator

I am sorry that I can’t give you a path to take to get a resolution, You can file a complaint with the state pharmacy board.  If you go down that path, file a complaint against the Pharmacist and there is a PIC (Pharmacist in charge) that is legally responsible to the board of pharmacy for the legal operation of the Rx dept as well as Costco…that has a pharmacy permit with the board of pharmacy, but you will probably only get back a statement that “we can’t force a pharmacist to fill a Rx”… which is true.. but .. if they wanted they could call the Pharmacist before a board meeting to explain their professional decision making process, but I doubt if they will…

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A Case for Cigarettes Causing a Cornucopia of Diseases Outside the Lungs, Heart

— Does smoking have a causal role in epilepsy, IBD, rheumatoid arthritis, and more?

https://www.medpagetoday.com/pulmonology/smoking/99698

Mendelian randomization studies appeared to bring researchers closer to establishing a causal association between smoking and a wider range of diseases.

Genetic variation in smoking liability, subject to genetic alleles being randomly passed between generations, was associated with a staggering amount of conditions — many going beyond the lung and cardiovascular diseases traditionally linked to cigarette smoking.

Epilepsy, type 2 diabetes, and several circulatory system diseases, digestive diseases, musculoskeletal system diseases, eye diseases, and cancers were traced back to smoking in a meta-analysis performed by Susanna Larsson, PhD, epidemiologist at Uppsala University in Sweden, and Stephen Burgess, PhD, biostatistician at the University of Cambridge in England. Their report was published in eBioMedicine.

Smoking’s strongest associations were to conditions including abdominal aortic aneurysm, peripheral artery disease, chronic and acute pancreatitis, periodontitis, and subarachnoid hemorrhage.

Larsson and Burgess noted that the findings support prior observational studies and concluded that their study “provided genetic evidence to support that smoking is a causal risk factor for a wide range of diseases.”

Some diseases, like epilepsy, have less clear mechanisms that could relate them to a person’s genetic liability for smoking initiation and lifetime smoking.

Yet for some conditions like inflammatory bowel disease (IBD) and rheumatoid arthritis, a plausible mechanism may be systemic inflammation caused by burning cigarettes and the reactive oxygen species generated, according to Larsson and Burgess, who suggested that smoking may also be causing endothelial dysfunction and thrombogenesis by microbial composition and immune response.

The association between smoking and eye diseases, such as age-related macular degeneration and age-related cataracts, are also not fully understood. However, the authors suggest that these too may be related to oxidative stress and reactive oxygen species that can damage eye tissue.

According to Larsson and Burgess, reducing smoking initiation should be “a key public health priority.”

Many studies have documented the risks of cigarette smoke exposure, even when secondhand. Last year, a study of French women found that those who were exposed to smoky rooms as children were more likely to develop rheumatoid arthritis.

Furthermore, ex-smokers remain at higher risk of fair or poor health depending on the duration of their old smoking habits.

The present meta-analysis included 29 published Mendelian randomization studies and 123 separate analyses conducted from publicly available genome-wide association studies.

“An important strength of Mendelian randomization studies is that common biases inherent in observational studies, including confounding and reverse causation, are diminished because the exposure (e.g., smoking) of interest is proxied by genetic variants that are usually unrelated to other risk factors and are not changed by the development of disease,” the investigators explained.

Nevertheless, they acknowledged that their results were based on several statistical assumptions and were subject to potential competing risk bias.

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VT BOP threaten to REVOKE the pharmacy license of ALL 32 WALGREEN PHARMACIES IN THE STATE

It is a sad era:

I remember when I told my father who I wanted to work for! I had just started college and my pride in this company was too big for others to understand! I had never worked for them before! And yet, I could not see myself be anywhere else!

I did not pursue any other employers! I did not want to!

I wanted to be a community pharmacist at this chain! And I had made up my mind!

There was pride in the values I thought I was following ! My commitment pushed me to work harder and harder! To sacrifice more and more!

I think a lot of pharmacists, technicians and students can relate!

Fast forward now, you see answers like these to recruitment emails , flowing around social media. This is not mine by the way. I believe I have blacklisted from Walgreens and CVS Health system entirely! I am not good enough for them. Lol.

But this type of answers has been more and more common especially in the last two years! Pharmacists, Technicians and Students are completely fed up with the lies, the greed, the manipulative values, the oppressive system of those companies !

They don’t even bother to say simply “ thank you for the consideration . But I must decline”. No, they are telling exactly what needs to be told with the hope that those major chain pharmacies will heed to the comments and bring some type of changes!

And yet nothing! More lies, more greed, more bullying, more profit over care! They don’t care!
But what they have failed to realize is that the sense of pride in working for them has gone! The sense of commitment is gone! The sense of attachment is gone! While they may have money, they don’t have the care, the love, the support and definitely not the respect of our profession and the public!

Basically, we no longer care for them! Their ship can burn and it won’t matter! As a profession that deeply cares , this is a bad spot for those employers! If we stop caring, they will eventually pay a very heavy price and unfortunately our patients will!
Now we hear of pharmacies being closed for a whole week… patient care is suffering and it is NOT the Pharmacy Personnel fault.

It all lies with companies! But would they change their ways?

Probably not! And we will continue to send emails like this!

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https://www.mychamplainvalley.com/news/local-news/vt-regulators-file-pharmacy-licensing-charges-against-walgreens/

The Vermont Office of Professional Regulation is asking the state Board of Pharmacy to punish Walgreens locations in the Green Mountain State. Should the pharmacy board do so, the punishment could lead to the pharmacies’ state licenses being revoked.

The regulation office has filed seven charges against the pharmacy chain over a series of alleged violations. Those allegations include insufficient staffing to meet the pharmacies’ workload, unplanned closures without allowing patients to get prescriptions filled elsewhere and over-scheduling of vaccine appointments.

The filing documents show that with 32 locations,

Walgreens is the largest owner and operator of pharmacies in the Green Mountain State. More than 25% of all licensed retail pharmacies in Vermont are Walgreens establishments.

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Minnesota seeks $1.25 million fine against CVS Caremark over pharmacy rules

https://m.startribune.com/minnesota-seeks-1-25-million-fine-against-cvs-caremark-over-pharmacy-rules/600168840/

Minnesota is threatening a $1.25 million fine against CVS Caremark, alleging it wrongly steered patients to CVS pharmacies owned by its parent company.

Caremark is a Rhode Island-based pharmacy benefit manager that structures how and where health plan enrollees can use their coverage to obtain medications.

The Minnesota Department of Commerce’s allegations focus on one of Caremark’s programs, called Maintenance Choice, which managed pharmacy choices for about 72,000 state residents using maintenance medicines last year.

Maintenance medications are those used to treat ongoing health problems, such as high cholesterol, asthma, diabetes and heart disease.

After filling their first three maintenance prescriptions, patients were required to use a CVS retail or mail-order pharmacy in which the pharmaceutical benefit manager (PBM) has an ownership interest, the Commerce Department said Thursday in a news release.

In some cases, patients “have needed to drive 20 to 130 miles,” the department said, to reach a CVS location rather than refilling medicines a much closer pharmacy.

“A PBM cannot require or incentivize a covered member to use a pharmacy it owns unless certain other conditions are met, such as providing the same incentives at non-owned pharmacies,” the news release said, “or imposing the same limits at its owned pharmacies as at its non-owned pharmacies.”

Phil Blando, a CVS Health spokesman, on Friday said the company is committed to complying with all laws and regulations that apply to its business as well as clients’ health benefit plans.

“While we maintain that federal laws governing ERISA plans preempt state laws and that the plan designs chosen by our Minnesota client plans are lawful, we are working cooperatively with the Minnesota Department of Commerce on this matter,” Blando said in a statement.

The Commerce Department has initiated a contested case against the company and is trying to stop practices that the department claims are a violation of the Minnesota Pharmacy Benefit Manager Licensure and Regulation Act. A prehearing conference is scheduled for May 31.

The civil money penalty is the largest the Commerce Department has sought thus far under state regulations for PBMs passed by the Legislature in 2019.

Pharmaceutical benefit managers structure the pharmacy portion of health plan benefits. They create networks of pharmacies where patients can get the best deals on medicines while negotiating prices with manufacturers. They also create “formularies” that specify patient copays for different drugs.

Owned by CVS Health, Caremark is one of the nation’s three largest PBMs alongside UnitedHealth Group’s Optum Rx and Express Scripts, which is owned by Cigna. Independent pharmacies have argued that PBM rules make it difficult for them to stay in business.

“This case demonstrates the importance of regulating PBMs in order to protect Minnesotans’ access to the critically important health care that pharmacies provide,” Commerce Commissioner Grace Arnold said in a statement. “The practices uncovered in this case show a corporation placing priority on its own profits rather than serving people.”

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