Last year, the Centers for Medicare and Medicaid Services (CMS) announced a historic 14.5% increase in Medicare Part B premiums, raising the average monthly cost from $148.50 to $170.10.
Amid inflation for a population that largely depends on a fixed income, a monthly increase of around $21.60 — or $259.20 a year — is hard to manage.
The announced increase is the largest in Medicare history. AARP Blames Three Main Culprits: Rising Health Care Costs, Withholding of Past Increases, and Controversy The drug against Alzheimer’s disease called Aduhelm in the future.
However, thanks to my favorite former MTV presenter turned comedian and now YouTuber political provocateur, this story may be getting a little more interest than it has so far. So, before we dive into why premiums aren’t declining mid-year, let’s look at the catalyst for price increases.
Controversial drug approval
The announcement that Biogen, a pharmaceutical manufacturer, had produced a drug capable of treating Alzheimer’s disease was met with optimism and hope for the nearly 5.6 million older Americans living with the disease.
However, not everyone shared the same excitement. The FDA approved the drug despite an overall unanimous decision by an 11-member outside advisory committee to disapprove the drug. Ten members voted no and one was unsure.
The approval sparked a string of FDA resignations, including Aaron Kesselheim, a professor of medicine at Harvard Medical School. Kesselheim wrote in his resignation letter that Aduhelm’s endorsement was; “…probably the worst drug approval decision in recent US history.”
So why would physicians like Kesselheim feel so strongly opposed to Aduhelm?
It’s weird, this drug clearly doesn’t work, and Aduhelm and the political pundits also don’t have the guts to say that
But
A 4th booster dose in a healthy 51-year-old man
3 Pfizers in a 3 year old who had covid
A 3rd dose in a 22-year-old man
Pax to Vax
Are equally poor/weak data, and yet 🦗 https://t.co/xk7tdp7wcD— Vinay Prasad, MD MPH 🎙️📷 (@VPrasadMDMPH) June 17, 2022
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Two clinical trials were stopped specifically because the drug showed no benefit for patients, and a follow-up trial showed only marginal possible benefit. So how did the FDA decide it was best to approve it?
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A close relationship
After poor clinical trial results, Biogen began meeting with key players within the FDA, including Dr. Billy Dunn. Dr. Dunn is the director of the FDA office that reviews Alzheimer’s drug applications for approval.
The FDA approved Aduhelm for Alzheimer’s disease knowing it probably didn’t work. At some point, Biogen had stopped experimental studies on this. There was no reason to believe the FDA wouldn’t and wouldn’t do it again. No matter the reason.
— Doctor FeelGood (@obxpilot23) June 16, 2022
A close collaborative relationship has formed between Dr. Dunn and Dr. Samantha Budd Haeberlein, who oversaw the clinical development of Aduhelm at Biogen. This collaboration included working together on projects and presentations supporting the drug.
Seems a bit too comfortable, in my opinion. William B. Schultz, former FDA assistant commissioner and general counsel for the Department of Health and Human Services, agrees:
“It is not appropriate for FDA officials to collaborate on publications and presentations with employees of companies whose applications are pending before those same officials.”
An FDA statement on the decision confirmed that their approval was; “…informed by science, medicine, politics and judgment, in accordance with applicable legal and regulatory standards.”
Below expectations
The initial price of $56,000 per year per patient is essentially what Medicare watchers are worried about. While prescription drugs generally fall under Part D, this drug is introduced intravenously in an outpatient setting, which makes it fall under Part B.
Biogen expected its drug to be widely used; however, when revenues fell well below expectations, they reduced the annual cost to $28,200 per year per patient. Additionally, only patients approved for clinical trials are now allowed to use the drug.
If the price had originally been set at $28,200, premiums would have been closer to $160.40 per month for Part B. This represents a potential savings of $116.40 per year – or the equivalent of a gas tank in today’s economy.
So why has this revolutionary drug not been widely accepted by the medical community? Again, there was significant disagreement over the effectiveness of the drug.
The executive committee of the American Neurological Association told doctors:
“Based on the clinical evidence, Aduhelm should not have been approved at this time.”
Even major players in clinical trials have spoken out against approval. Dr. Vissia Viglietta, former Biogen chief medical officer who helped design the trials, said:
“This approval should not have happened. It goes against everything I believe in scientifically and lowers the rigor of regulators.
With so many outspoken opponents of this drug’s approval, you have to wonder what is driving the FDA in the approval process. While risking sounding like a conspiracy theorist, some like Russell Brand believe it has to do with political donations.
But even if the committee’s overall vote is 👎, the FDA is free to disregard it and approve anyway, as it infamously did with Aduhelm.
—Erick Turner (@eturnermd1) June 17, 2022
RELATED: Biden is the most unpopular president since tracking began in 1945
It’s all about green, baby
Mr. Brand claims in his YouTube video that the FDA is 45% funded by those it is responsible for regulating. It has been reported that more than $5.9 million has been donated by partners in the pharmaceutical and health products industry to Biden’s presidential campaign.
In 2020, the pharmaceutical sector was ranked the top lobbying industry with $156.6 million in campaign donations. It is widely believed that Big Pharma gives more to Republicans than Democrats.
Large pharmacy. pic.twitter.com/samxk5rxKv
—Andy (@andrewldonald) June 21, 2022
The truth is that they look reasonably evenly down the aisle; however, in 2021, 60% of donations went to Democrats. Big Pharma also employs approximately 1,500 lobbyists on the Hill. It is a prominent voice constantly whispered in the ears of policy makers in Washington.
Weak excuses and vague promises
CMS claimed that the initial price hike would be offset by the 5.9% increase in the cost of living for Social Security benefits. Little consolation for those on fixed incomes experiencing record inflation.
The idea of reassessing premiums mid-year would have been “unprecedented,” according to Tricia Neuman, executive director of health insurance policy for the Kaiser Family Foundation. DHHS goes on to say that the mid-year premium cut would have encountered “legal and operational hurdles.”
In other words, it would have been difficult. However, we have seen many unprecedented behaviors in the COVID world, and it is clear that the Treasury Department is capable of issuing mass checks to Americans.
It’s hard to see why it would have been too difficult to issue reimbursement checks to our most medically and financially “vulnerable” population.
What will premiums look like next year? The Biden administration’s 2023 budget still has projections at $170.10. However, CMS says it will likely be different… somewhat.
The devil is in the details and wording in this case.
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