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.

Report: Congress Warned to Shore Up Social Security Reserves

Published in the Woonsocket Call on April 26, 2020

Each year, starting in 1941, the Social Security Board of Trustees has presented a required report on the financial status of the program to the Congress. Now amidst the world-wide coronavirus (COVID-19) pandemic forcing the shuttering of the nation’s businesses triggering the worst economic downslide since the 1930s Great Depression, the Social Security Board of Trustees releases its 276-page 2020 annual with a warning that Social Security could deplete its trust funds reserves by 2035, if Congress does not act to increase the trust fund reserves. However, because of payroll taxes, revenue to the program would ensure that at least 79 percent of benefits would be paid after 2035 if Congress fails to address solvency.

During the last five weeks, about 24 million Americans have lost their jobs due to COVID-19 Pandemic. With fewer people paying payroll taxes, this will further reduce revenue to Social Security, the impact depending upon how length and severity of the economic downturn. During the pandemic, the number of Americans who pass away, become disabled or survivors will also affect the actuarial accounting of the trust fund’s finances.

“The projections in this year’s report do not reflect the potential effects of the COVID-19 pandemic on the Social Security program. Given the uncertainty associated with these impacts, the Trustees believe it is not possible to adjust estimates accurately at this time,” said Andrew Saul, Commissioner of Social Security. “The duration and severity of the pandemic will affect the estimates presented in this year’s report and the financial status of the program, particularly in the short term.” says Saul.

“Today’s report confirms that Social Security’s financing is strong in the near term, but it will not have enough to pay 100 percent of promised benefits in long term. The report underscores why it is so important that Congress take action now to prevent a 21 percent cut from occurring in 2035, by ensuring Social Security is fully funded and strengthened for today’s seniors and future generations, who will need it even more,” said Chairman John B. Larson (D-CT), House Ways and Means Social Security Subcommittee in a statement.

“As we face the COVID-19 pandemic, Social Security’s role is even more important than ever. During this volatile time of economic uncertainty, Social Security remains the one constant that all current and future beneficiaries can count on. It has never missed a payment. That’s why we must act now to expand and enhance Social Security with the Social Security 2100 Act,” states Larson. “His legislation will ensure Social Security remains solvent for the next 75 plus years, while expanding benefits. Moreover, the expansion of Social Security’s steady monthly payments would be an automatic boost to the economy,” he adds.

Gauging the Financial Health of Social Security

According to the Washington, DC-based National Committee to Preserve Social Security and Medicare (NCPSSM), at the end of 2019, about 64 million people were receiving benefits: 48.2 million retired workers and their dependents; 6 million survivors of deceased workers; and 9.9 million disabled workers and their dependents. About 178 million workers had earnings covered by Social Security and paid payroll taxes in 2019.

By 2035, (which is the same as last year’s estimate) when today’s 51-year-olds reach the retirement age and today’s youngest retirees turn 78, retirees will face a 21-percent across-the board benefits cut (that could grow to 25 percent over time) if Congress does not make significant changes to revenue, benefits, or both to shore up the depleted trust fund.

This year’s report announces that Social Security has an accumulated surplus of approximately $2.9 trillion. It projects that, even if Congress took no action whatsoever, Social Security not only can pay all benefits and associated administrative costs until 2035, it is 91 percent funded for the next quarter century, 85 percent for the next half century, and 82 percent for the next three quarters of a century. At the end of the century, in 2095, Social Security is projected to cost just 5.86 percent of gross domestic product.

The newly released Trustees report notes that the Disability Insurance (DI) Trust Fund, which pays disability benefits, will be able to pay scheduled benefits until 2065, 13 years later than in last year’s report. At that time, the fund’s reserves will become depleted and continuing tax income will be sufficient to pay 92 percent of scheduled benefits.

As to the Hospital Insurance (HI) Trust Fund, which pays Medicare Part A inpatient hospital expenses, the Trustee’s report says that this program will be able to pay scheduled benefits until 2026, the same as reported last year. At that time, the fund’s reserves will become depleted and continuing total program income will be sufficient to pay 90 percent of total scheduled benefits.

Finally, the Trustee’s report noted that the Supplemental Medical Insurance (SMI) Trust Fund, consisting of Part B, which pays for physician and outpatient services, and Part D, which covers prescription drug benefits, is adequately financed into the indefinite future because current law provides financing from general revenues and beneficiary premiums each year to meet the next year’s expected costs. Due to these funding provisions, the rapid growth of SMI costs will place steadily increasing demands on both taxpayers and beneficiaries, says the Trustee’s report.

Social Security Advocates Weigh in

“Medicare and Social Security are more crucial than ever as Americans face the one-two punch of the coronavirus’s health and economic consequences, says AARP CEO Jo Ann Jenkins in a statement following the release of the Trustees report, noting that the security provided by Social Security’s guaranteed benefits and Medicare’s health coverage is indispensable.

“Today’s reports show that both programs remain strong. However, it is crucial for Congress to come together in a bipartisan way to address the long-term funding challenges to ensure individuals will get the benefits they have earned. One way to protect Medicare is to lower the cost of health care and prescription drug prices, suggests Jenkins.

“Social Security is strong. But its long-term fiscal health cannot be guaranteed if the White House and Congress continue to use the program’s financing structure for economic stimulus during the COVID-19 crisis,” says Max Richtman, NCPSSM’s President and CEO. “Those who would like to dismantle Social Security are using the pandemic to launch a stealth attack. A broad-based payroll tax cut, as the President has proposed, would interfere with Social Security’s traditional revenue stream while failing to deliver effective or equitable stimulus,” he warns.

According to Richtman, Social Security already provides more than $1.6 trillion in annual economic stimulus as seniors spend their benefits for essential goods and services in their communities. “Now is not the time – in fact, it is never the time – to tamper with a program that more than 40% of retirees rely upon for all of their income,” he says.

Richtman notes that the Trustees estimate that the Social Security cost-of-living adjustment (COLA) for 2021 will be 2.3 percent. However, that projection does not reflect the impact of the pandemic on inflation, and the actual COLA for next year could be lower, he says.

“We do not know the extent of the pandemic’s impact on Social Security, but we do know that seniors need a boost in their benefits. Let’s strengthen the program now by eliminating the payroll tax wage cap and demanding the wealthy pay their fair share. That way, we can expand benefits and adopt a more accurate cost-of-living inflation formula for seniors,” suggests Richtman.

As for Medicare, says Richtman, the program’s financial future is relatively unchanged from last year’s report, but the impact of the pandemic is not reflected. “The Medicare Part A Trust Fund will become exhausted by 2026, after which the program still could pay 90 percent of benefits, if Congress does nothing to strengthen Medicare’s finances,” he adds.

Adds Richtman, the Trustees estimate that the Medicare Part B premium will rise to $153.30 per month in 2021, an $8.70 increase over last years.

Nancy Altman, President of Social Security Works and the Chair of the Strengthen Social Security Coalition, agrees with Jenkins and Richtman that the Trustee’s report shows Social Security will remain strong through the rest of the 21st century and beyond, notwithstanding current circumstances. “Though the exact impact of today’s pandemic and economic conditions will not be clear until next year’s report, Social Security’s strength will shine through next year, as well. Social Security is built to withstand today’s events,” says Altman.

Altman believes that Social Security is a solution and the program continues to pay benefits automatically on time, especially with retiree’s 401(k)s taking a hit because of the pandemic crisis. “It is past time to increase Social Security’s modest but vital benefits, while requiring the wealthy to pay their fair share,” she says.

Stimulating the Economy by Slashing Payroll Taxes

Congress has passed payroll tax cuts –in 2011 and 2012 – in an attempt to stimulate the economy during a downturn. The recently enacted $2.2 trillion economic stimulus legislation passed last month, called the CARES Act, does allow for employers to defer their payroll tax payments but does not actually cut the levies, which are used to fund Medicare and Social Security.

Now GOP lawmakers led by President Donald Trump are using the virus pandemic as an excuse to slash payroll contributions, Social Security’s dedicated funding. Cutting the Social Security payroll taxes would reduce the amount of money withheld from employee paychecks, increasing their take-home pay.

Using a payroll tax cut to provide a financial stimulus in an effort to forestall a recession caused by COVID-19 pandemic “undermines the earned benefit nature of the program,” warns Dan Adcock, NCPSSM’s Director of Government Relations & Policy.

“Social Security is an earned benefit fully funded by the contributions of workers throughout their working lives. A payroll tax cut suspension or deferral chips away at that fundamental idea, making it easier each time it is enacted to turn to it again to meet some future crisis, until the payroll tax is not just cut but is eliminated, undermining the program in this manner would help achieve the goals of opponents of Social Security including those who would privatize the program,” says Adcock.

Adcock says that NCPSSM opposes a Congressional effort to alter the payroll tax that reduces revenue flowing into the Social Security trust fund or undermines the “earned right” nature of the benefit. “We support the enactment of tax incentives – other than cutting, suspending or deferring the Social Security and Medicare payroll taxes – to encourage employers to keep their workers during this emergency,” he says.

Congressional lawmakers can extend the long-term solvency of the Social Security while improving earned benefits through passing legislation like Congressman John Larson’s H.R. 860, the Social Security 2100 Act, says Adcock. At press time, the House bill has over 208 cosponsors and its Social Security Subcommittee has held several hearings on the bill.

Several other bills to protect and expand Social Security benefits have also been introduced in both House and Senate chambers The presumptive Democratic nominee for President, former Vice President Joe Biden, has endorsed a Senate proposal sponsored by Senators Elizabeth Warren (D-MA) and Ron Wyden (D-OR) that would provide all Social Security beneficiaries with an extra $200/month during the coronavirus health crisis.

As to Medicare, lawmakers can take action to cut beneficiaries’ out of pocket costs and boost Medicare’s fiscal health by passing H.R. 3, The Lower Drug Costs Now Act — which would save the program some $400 billion in projected prescription drug costs by allowing the government to negotiate prices directly with Big Pharma.

Simply put, one sure method of ensuring the financial viability of Social Security is to require millionaires to pay their fair share of payroll taxes by removing or increasing the current income cap on payroll taxes, suggests Adcock.

Shoreing Up Social Security

With over 90 days until the upcoming 2020 Presidential elections, seniors might reach out to those running for Congress and the White House and call for the strengthening and expansion of Social Security. It’s time to protect the viability of the program for those currently receiving benefits and for the younger generations who follow.

View the 2020 Trustees Report at http://www.socialsecurity.gov/OACT/TR/2020/.

View an infographic about the program’s long-term financial outlook at http://www.socialsecurity.gov/policy/social-security-long-term-financial-outlook.html

Herb Weiss, LRI’12, is a Pawtucket writer covering aging, healthcare and medical issues. To purchase Taking Charge: Collected Stories on Aging Boldly, a collection of 79 of his weekly commentaries, go to herbweiss.com.