Controversial move by CMS limits coverage for new Alzheimer’s drug, Aduhelm 

Published in RINewsToday on April 25, 2022

Earlier this month, amid the pleas of the Alzheimer’s Association, the National Committee to Protect Social Security and Medicare, and other aging advocacy groups, the Centers for Medicare & Medicaid Services (CMS) made its final decision to limit their Medicare coverage of the controversial Alzheimer’s drug, ADUHELM® , for only those Medicare recipients participating in clinical studies overseen by the National Institutes of Health (NIH) or in other approved clinical trials.

When releasing its decision on April 7, CMS noted from the onset, the federal agency “ran a transparent, evidence-based process that incorporated more than 10,000 stakeholder comments and more than 250 peer-reviewed documents into the determination” to make its decision.

Calls for More Rigorous Studies

According to CMS, over 6 million older Americans are believed to have Alzheimer’s, and this prevalence is expected to rise to 14 million by 2060, barring effective interventions. CMS stated that effective treatments are needed, and because of the early, but promising, evidence and the immense burden of this devastating disease on the Medicare population, the agency is finalizing Medicare coverage, calling for rigorous studies approved by the U.S. Federal Drug Administration (FDA) and NIH to help answer whether this class of drugs improves health outcomes for patients.

“Science, evidence, and stakeholder input led our team of career civil servants and clinicians through this national coverage determination process. There is potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improving health outcomes to say that it is reasonable and necessary for people with Medicare, which is key consideration for CMS when making national coverage determination, said Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, in a statement announcing CMS’s regulatory payment decision.

“In arriving at this final decision, we looked at the unique circumstances around this class of treatments and made a decision that weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm,” added Fleisher. “If a drug in this class shows evidence of clinical benefit through the traditional FDA approval process, then CMS will provide broad access and ensure the results from the rigorous trials are generalizable for people with Medicare participating in a CMS-approved study, such as a registry,” she said, noting that this decision was made to provide CMS flexibility to respond quickly to providing coverage for any new drugs in this class showing a clinical benefit. 

Biogen, a biotechnology company that manufacturers ADUHELM®m , was quick to give its opinion about CMS’s final decision about coverage of this drug. The Cambridge, Massachusetts based company charged that “this unprecedented decision effectively denies all Medicare beneficiaries access to ADUHELM®m , the first and only FDA approved therapy in a new class of Alzheimer’s drugs. It may also limit coverage for any future approved treatment in the class. These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas.”

When additional data from this new class of treatments become available, Biogen urged CMS to reconsider its final decision for all FDA-approved amyloid-beta targeting therapies. The company says that it is carefully considering its options and will provide updates as the company further evaluates the business impact of this decision.

Creating Unnecessary Barriers to Care 

Calling the CMS decision wrong, the Chicago-based Alzheimer’s Association expressed deep disappointment, charging that it has essentially ignored the needs of people living with Alzheimer’s disease. “CMS has created unnecessary barriers for individuals with Alzheimer’s disease. Patients with Alzheimer’s, a fatal disease, should have FDA approved treatments covered by Medicare just as those facing other diseases do,” said Harry Johns, Alzheimer’s Association chief executive officer. 

Notably, CMS has said in its decision the only way for patients to access the first approved FDA treatment targeting amyloid in those living with Alzheimer’s is to enroll in a clinical trial. While we note CMS has expanded where those clinical trials may take place, in reality this remains an unnecessary and never before imposed barrier to access an FDA-approved treatment, says Johns.

“People living with MCI, Alzheimer’s disease and other dementia deserve the same access to therapies given to those living with other conditions like cancer, heart disease and HIV/AIDS. They deserve the opportunity to assess if an FDA-approved treatment is right for them,” said Joanne Pike, Dr.P.H., Alzheimer’s Association president. “Drugs that treat people in the early stages of Alzheimer’s could mean more time for individuals to actively participate in daily life, have sustained independence and hold on to memories longer,” she said.

According to the Alzheimer’s Association, CMS has incorporated one of its recommendations into the final rule. “Importantly, CMS has decided to utilize a registry for future treatments granted full FDA approval. The Alzheimer’s Association registry will play an important role in collecting and analyzing real-world data. This registry will monitor and report clinical and safety endpoints for patients treated with FDA-approved AD therapies, including accompanying diagnostics, to track the long-term outcomes associated with these therapies in real-world settings. Similar successful registries in heart disease and cancer have enabled researchers, clinicians, health systems and payers to track the long-term performance of therapies using a large, real-world evidence dataset,” the advocacy group says. 

The Alzheimer’s Association also expressed strong concern about the immediate impact CMS’s decision will have on Alzheimer’s and dementia research and innovation. “The agency’s decision to essentially reject the Accelerated Approval Pathway for monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease is broad overreach. Accelerated approval is a pathway created by Congress and utilized by FDA to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need. Alzheimer’s is a deadly disease with no survivors,” stated the advocacy group.

“The decision by CMS is a step backward for families facing Alzheimer’s disease,” said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer. “Years of increased research funding has led to more progress and innovation than ever before, but today’s decision may halt this progress as developers question if there is a pathway forward to coverage,” she said.

Calls for Reducing Cost of Medicare Part B Premiums

Max Richtman, President and CEO of the National Committee to Preserve Social Security and Medicare, calls on CMS to “swiftly reduce the hefty 2022 Medicare Part B premium increase ($21.60 per month), now that the agency has made its final decision to limit coverage of the controversial Alzheimer’s drug, ADUHELM®m, to patients in clinical trials.” 

“The spike in Medicare Part B premiums was partly based on the drug’s exorbitant cost (originally priced at $56,000 per year) and the potential expense of wider coverage,” says Richtman, noting that the agency is still “reviewing” Part B premiums, under previous direction from HHS Secretary Xavier Becerra. “Medicare beneficiaries struggling to pay their bills need relief from this year’s premium increase as soon as possible, warns Richtman. .

“The Aduhelm controversy highlights the urgent need for Medicare to be able to negotiate drug prices with Big Pharma. If the price of Aduhelm had been negotiated, it is unlikely that it would have impacted Medicare premiums so dramatically in the first place,”  adds Richtman, 

For a fact sheet on Medicare coverage policy for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, visit https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-policy-monoclonal-antibodies-directed-against-amyloid-treatment-alzheimers-disease.

To read the final NCD CED decision memorandum, visit https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305.

Social Security ’21 Cola Increase Anemic

Published in RINewsToday.com on on October 19, 2020

With the Social Security Administration’s (SSA) announcement of next year’s Social Security and Supplemental Security Income’s (SSI) meager cost-of-living adjustment (COLA), over 70 million beneficiaries will only see an increase of 1.3 percent in their monthly checks in 2021.  Last year’s COLA increase was 2.8 percent, the largest in seven years.

According to SSA, the 1.3 percent cost-of-living adjustment (COLA) will begin with benefits payable to more than 64 million Social Security beneficiaries in January 2021. Increased payments to more than 8 million Supplemental Security Income (SSI) beneficiaries start on December 31, 2020. 

SSA ties the annual COLA to the increase in the Consumer Price Index as determined by the Department of Labor’s Bureau of Labor Statistics. 

The maximum amount of earnings subject to the Social Security tax (taxable maximum) will increase to $142,800 from $137,700, says SSA.

The earnings limit for workers who are younger than “full” retirement age will increase to $18,960. (SSA deducts $1 from benefits for each $2 earned over $18,960.)

The earnings limit for people reaching their “full” retirement age in 2021 will increase to $50,520. (SSA deducts $1 from benefits for each $3 earned over $50,520 until the month the worker turns “full” retirement age.)

There is no limit on earnings for workers who are “full” retirement age or older for the entire year. 

Next Year’s COLA Increase Not Enough 

Max Richtman, president and CEO of the National Committee to Preserve Social Security and Medicare (NCPSSM) calls the increase as inadequate especially for COVID-Ravaged Seniors and noted that it’s the lowest since 2017.  

“The timing could not be worse. The COVID pandemic has devastated many older Americans both physically and financially.  Seniors living on fixed incomes need a lifeboat; this COLA increase is more like an underinflated inner tube,” says Richtman.

The average Social Security beneficiary will see a paltry $20 month more in benefits in 2021, calculates Richtman. “This COLA is barely enough for one prescription co-pay or half a bag of groceries. Worse yet, seniors could lose almost half of their COLA increase to a rise in the Medicare Part B premium for 2021, the exact amount of which has not yet been announced,” he warns.  

“The current COLA formula – the CPI-W – is woefully inadequate for calculating the true impact of inflation on seniors’ pocketbooks. It especially under-represents the rising costs that retirees pay for expenses like health care, prescription drugs, food, and housing. We support the adoption of the CPI-E (Consumer Price Index for the Elderly), which properly weights the goods and services that seniors spend their money on,” says Richtman. 

Examining the Growth of SSA COLAs 

Social Security checks in 2020 are almost 20 percent lower than they otherwise would be, due to the long-term impact of extremely low annual inflation adjustments, according to a newly released analysis by The Senior Citizens League (TSCL).  The analysis comes as SSA announced that the 2021 COLA will be just 1.3 percent, making it one of the lowest ever paid. 

“People who have been receiving benefits for 12 years or longer have experienced an unprecedented series of extremely low cost-of-living adjustments (COLAs),” says TSCL’s Mary Johnson, a Social Security policy analyst for the Alexandria, Virginia nonpartisan senior advocacy group. “What’s more those inflation adjustments do not account for rapidly rising Medicare Part B premiums that are increasing several times faster than the COLA,” she says, noting that this causing those with the lower Social Security benefits to see little growth in their net Social Security income after deduction of the Part B premium.  

Johnson’s COLA analysis, released on Oct. 13, compared the growth of retiree benefits from 2009-through 2020 to determine how much more income retirees would receive if COLAs had grown by a more typical rate of 3 percent. TSCL’s analysis found that an “average” retiree benefit of $1,075 per month in 2009 has grown to $1,249 in 2020, but, if COLAs had just averaged 3 percent, that benefit would be $247 per month higher today (19.8 percent higher), and those individuals would have received $18,227.40 more in Social Security income over the 2 010 to 2020 period. 

During that period COLAs have averaged just 1.4 percent. In 2010, 2011, and 2016 there was no COLA payable at all and, in 2017, the COLA was 0.03 percent. “But COLAs have never remained so low, for such an extended period of time, in history of Social Security,” says Johnson, who has studied COLAs for more than 25 years.  Over the 20-year period covering 1990 to 2009, COLAs routinely averaged 3 percent annually, and were even higher before that period. 

According to Johnson, the suppressed growth in Social Security benefits not only creates ongoing benefit adequacy issues, but also Medicare budgetary programs when the COLA is not sufficient to cover rising Part B premiums for large number of beneficiaries. When the dollar amount of the annual Medicare Part B premium increase is greater than the dollar amount of an individual’s annual COLA, the Social Security benefits of about 70 percent of Medicare beneficiaries are protected by the hold-harmless provision in the Social Security Act.  The Medicare Part B premium of those individuals is reduced to prevent their net Social Security benefits from being lower than the year before, she says. 

However, Johnson notes that the people who are not covered by hold harmless include higher income beneficiaries, beneficiaries who have not started Social Security yet and who pay for Medicare by check and about 19 percent of beneficiaries whose incomes are so low that their state Medicaid programs pay their Medicare Part B premiums on their behalf. 

Johnson says, “that a provision of a recently enacted government spending bill restricts Part B premium increases in 2021. The bill caps the Part B premium increase for next year at the 2020 amount plus 25 percent of the differences between the 2020 amount and a preliminary amount for 2021.”

Don’t look for the “potential Part B spike” to go away, warns Johnson. “Unless Congress acts to boost Social Security benefits and finds a better way to adjust benefits for growing Medicare costs, this problem will continue occur with greater frequency in the future,” she says.

Fixing SSA’s COLA Problem Once and For All

During the COVID-19 pandemic seniors are relying more on their Social Security check but continue to face cost increases each year beyond the extra income provided by the COLA, says Social Security Subcommittee Chairman John B. Larson (D-Connecticut) in a statement following SSA’s announcement of its tiny 2021 COLA increase. “It’s time to fix that by enacting the Social Security 2100 Act.,” says the Connecticut Congressman calling for passage of his legislative proposal that would strengthen SSA benefits by basing the COLA on what seniors actually spend on items such as medical expenses, food, and housing. Under this new CPI-E index, a beneficiary would experience benefits that are 6 percent higher by the time they reach age 90. 

Meanwhile, Congressman Peter DeFazio (D-Oregon) sponsored and Larson, a co-sponsor, have proposed emergency legislation to increase next year’s COLA up to 3 percent. “Due to the COVID-19 pandemic, seniors are facing additional financial burdens in order to stay safe,” said DeFazio.  “This absolutely anemic COLA won’t even come close to helping them afford even their everyday expenses, let alone those exacerbated by COVID-19. Raising the COLA to 3 percent 2021 will provide seniors with an immediate, crucial lifeline during the ongoing coronavirus crisis,” says the Oregon Congressman. DeFazio’s legislative proposal, the Social Security Expansion Act, would also provide a permanent fix to the COLA formula, like Larson using a CPI-E index to factor in seniors’ actual, everyday expenses.

Social Security Recipients Thirsty for COLAs

Published in Pawtucket Times on October 19, 2015

With Christmas fast approaching, almost 65 million people who collect Social Security checks will get hit hard in their pocketbooks. On Thursday, the Social Security announced that there will be no cost of living adjustments (COLA) for 2016. It’s the third time this has happened in over 40 years. .

Unless Congress promptly acts to change the law to give COLAS, Medicare premiums will also be increasing dramatically for almost one-third of Social Security recipients. “The average American senior simply can’t afford a triple-digit increase for their Medicare coverage, says Max Richtman, President/CEO of the National Committee to Preserve Social Security and Medicare (NCPSSM) in a statement. The Washington, D.C.-based organization has lobbied Congress to pass legislation to address this urgent policy issue. “For millions of seniors, this large Medicare hike is devastating and a result of a well-intended “hold harmless” provision that left out too many Medicare beneficiaries,” he says.
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According to Richtman, “All of this was triggered by a zero COLA increase in Social Security for 2016, confirming yet again, that the current Social Security COLA formula isn’t accurately measuring seniors’ expenses. Seniors across this nation understand how important having an accurate measure of the increase in their real costs is to their day-to-day survival.”

House Democrats Rally for a COLA

Just one day before SSA’s announcement of no COLA next year, Congressman David N. Cicilline (D-RI), and 55 Democratic House members had sent a letter to the Social Security Administration (SSA) calling for the federal agency to find a way to provide a COLA for 2016. Not surprisingly Cicilline was not joined by House GOP lawmakers. Only Congressional action can revise this decision.

In the Ocean State, there are 153,349 beneficiaries who received $266,541,000 in total benefits in December 2014. In January 2015, beneficiaries received a 1.7% COLA, which averaged $29.55 per month, or $354.58 per year.

“Seniors, who are relying on Social Security for their retirement, have seen the costs of everything go up and deserve a COLA so they can have their basic needs met,” said Cicilline. “I hear from Rhode Islanders every day who are living on Social Security about their struggles with the rising costs of housing, food, and medicine. In fact, it seems everything is going up, except their Social Security check and this is dead wrong.”

SSA’s announcement on October 14 clearly shows that the current method of calculating COLA’s for Social Security beneficiaries negatively impacts the recipients, says Cicilline. The Democratic Congressman calls on Congress to quickly fix this problem now. The lawmaker has co-sponsored H.R. 1811, the Protecting and Preserving Social Security Act, to do just that.

Cicilline charges that the Social Security Administration has used the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W) to determine whether the cost-of-living has increased. According to the Washington Post, the “biggest reason retirees aren’t getting a raise” is due to lower fuel prices, even though medical, housing, and food costs have increased.

It’s time to change the way COLAs are calculated, says Cicilline. Critics to the existing formula charge that fuel prices are less important in determining cost of living for the nation’s seniors – individuals ages 65 and older make up only 16% of all licensed drivers in the United States. To fix formula glitch, Cicilline has signed on as a co-sponsor of the CPI-E Act, which would replace CPI-W with the Consumer Price Index for the Elderly. CPI-E more accurately reflects cost of living for today’s older persons by weighting the cost of housing and medical care more compared to CPI-W. It also de-emphasizes fuel and transportation costs.

Blunting the Pain of Medicare Premium Hikes

Promptly responding to SSA’s double whammy of no COLA for 2016 and hikes in Medicare premiums, AARP, the nation’s largest aging advocacy organization in a letter called on Congress to “pass a fix.”

In her correspondence, Nancy LeaMond AARP’s EVP and Chief Advocacy and Engagement Officer, asks Congress to protect all Medicare beneficiaries from sharply increased out-of-pocket costs in light of the COLA announcement, requesting specifically that Congress “reduce. the impact of the sudden, sharp increases in the Part B premiums and deductible as soon as possible. Ideally, all Medicare beneficiaries should be held-harmless in the face of no Social Security COLA adjustment.”

LeaMond’s letter notes that 16.5 million Americans face sharp premium increases and that “all Medicare beneficiaries will see their Part B deductible increase 52 percent…from $147 to $223.” Additionally, AARP reiterates its opposition to the Chained Consumer Price Index (CPI), noting that “the Social Security COLA would be even more inaccurate and benefits would be even less adequate if recent proposals to adopt a Chained CPI had been enacted.

AARP has opposed all Administrative and Congressional attempts to enact a Chained CPI, and says it will continue to do so, says LeaMond, because the Chained CPI would further under reported inflation experienced by Social Security beneficiaries, and further erode their standard of living, cutting an estimated $127 billion in Social Security benefits from current and near retirees in the next ten years alone.”

With Capitol Hill polarized by political a House and Senate captured by ultra conservatives, Social Security beneficiaries will have to find ways to stay financially afloat until Congress can reduce the damaging impact of the Part B premium increases with no COLA increase to reduce the pain. Aging groups push for holding beneficiaries harmless to Medicare premium increases. With the election over a year off, law makers might just listen or face the wrath of older Americans who just exercises their right to vote at the polls.

Herb Weiss, LRI ’12 is a Pawtucket writer covering aging, health care and medical issues. He can be reached at hweissri@aol.com.