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.

End Filibuster and Use Federal Government to Secure Elections

Published in RINewsToday.com on October 4, 2021

The clock is ticking… It’s 399 days before the upcoming midterm elections.

Following the Democrats winning the White House and taking control of both the House and Senate chambers, Republican-controlled state houses across the nation moved quickly to pass restrictive legislation to block access to vote. The Republican lawmakers see this legislative strategy as a way to protect election integrity. On the other hand, Democrats say the Republican legislative efforts are in large part motivated by false voter fraud claims coming out of the 2020 elections that continue to this day.

According to the New York-based Brennan Center for Justice (BCJ), “between   and July 14 2021, at least 18 states enacted laws that restrict access for the vote. These laws make mail voting and early voting more difficult, impose harsher voter ID requirements, and make faulty voter purges more likely among other things.More than 400 bills with provisions that restrict voting access have been introduced in 49 states in the 2021 legislative sessions.”

“There may be more new state voting laws still to come this year. Active regular legislative sessions continue in California, Massachusetts, Michigan, North Carolina, New Jersey, Ohio, Pennsylvania and Wisconsin. And Maine’s special legislative session is ongoing,” warns BCJ.

At the same time, more than 900 bills were dropped in the legislative hopper expanding voter access in 49 states during the 2021 legislative session, says BCJ, noting that at least, 25 states enacted 54 laws with provisions to expand voting access. These laws expanded access to early and mail voting, make voter registration easier, and restoring voting rights to Americans with past convictions.

Democratic lawmakers say Congress has the power to block Republican efforts at the state level to restrict access to voting.As of March 2021, the For the People Act passed by the House now awaits action in the Senate, and would reduce the impact of many state-level restrictions by creating new national standards for elections, while preventing common forms of voter suppression and easing access to voting. Democrats are also pushing for passage of the John Lewis Voting Rights Advancement Act to protect voters by preventing discriminatory election laws from being implemented.

Safeguarding Ballot Access for Seniors

The Washington, DC-based National Committee to Protect Social Security and Medicare (NCPSSM) along with 40 senior advocates and political influencers, call on Senators Krysten Sinema (D-AZ) and Joe Manchin (D-WV) to support changes to the filibuster to protect older Americans’ voting rights. So long as the moderate Senators oppose filibuster reform, Senate Democrats have no legislative path to enact S.1, For the People Act, legislative, passed by the House to ensure voting rights.  Under current Senate rules, Senate Republicans can block S.1 through a filibuster, a legislative procedure requiring a “supermajority” of 60 votes for passage.  Democrats need to pass filibuster reform to pass this legislation.

In a Sept. 21 letters to the two moderate Senators, NCPSSM President and CEO Max Richtman writes that adjusting the Senate filibuster is the only way to safeguard ballot access for seniors if enough Republican Senators won’t support new federal voting rights legislation.  Such legislation is necessary, says Richtman, because of restrictive, new state laws that infringe on seniors’ right to vote by mail.

“We urge you to support a narrow change to the filibuster rule to allow the Senate to approve new voting rights legislation by a simple majority vote. This crucial legislation will help to protect our democracy and the right to vote for all Americans, including older Arizonans who cast ballots by mail,” says Richtman. 

“Currently, seniors who are immobile, sick, or don’t want to risk being infected by the delta COVID variant can request mail ballots — along with those who cannot drive or lack access to mass transit,” says Richtman. “Voting by mail allows these older citizens to exercise their constitutional rights in a safe, convenient way. In 2020, the majority of voters over age 65 cast their ballots by mail.  Multiple studies have shown vote-by-mail to be consistently free of fraud,” he says.

Richtman urged Sinema and Minchin to support a narrow change to the filibuster rule to allow the Senate to approve S. 1, the For the People Act, by a simple majority vote. “This crucial legislation will help to protect our democracy and the right to vote for all Americans, including older Arizonans who depend on voting by mail,” he says.

According to Richtman, study findings note that vote-by-mail to be consistently free of fraud.  For instance, a Massachusetts Institute of Technology study results show that  only 0.00006% of 250 million votes by mailed ballots nationwide were fraudulent. Additionally, scholars at Stanford University analyzing 1996-2018 data in California, Utah and Washington found vote-by-mail did not advantage one political party over another, he said.

During the 2020 elections, many seniors chose to vote-by-mail to exercise their right to vote, more important to stay safe during the COVID-19 pandemic,” says Richtman, noting that 41% of voters age 50-64 and 55% of voters over age 65 voted by mail in the 2020 election. 

“The safety and convenience of this method of voting is likely to prove equally effective in future elections – unless state legislatures decide to obstruct voting by mail,” adds Richtman.

Richtman said, “Given the advantages and encouraging results of the nation’s vote-by-mail experience, and the paucity of evidence of voter fraud, we question why so many states are moving in the opposite direction – to discourage vote-by-mail.”

Ensuring Voter Access Once and For All

“The For the People Act would protect all Americans from new state voter suppression laws by setting national mail-in voting standards and guaranteeing no-excuse mail-in voting,” says Richtman, noting that  S. 1 requires states to give every voter the option to vote by mail, calls for prepaid postage for all election materials and state-provided drop boxes for federal races.

A call to Congress to strengthen, expand Social Security & Medicare 

Published in Rhode Island News Today on September 6, 2021

The 2021 Annual Report of the Board of Trustees of the Federal Old-Age and Survivors Insurance (OASI)) and the Social Security Disability trust fund (SSDI), released last week, gives Congress this stark warning: the Social Security Trust fund is heading toward insolvency in 13 years while SSDI will see its reserve funds depleted in 2057, eight years sooner than last year’s estimate. As a whole, combined, the two Social Security trust fund reserves will be depleted in 2034, a year earlier than estimated made in last year’s Trustee report.

However, there is good news. This year’s report notes that there is more than enough time for lawmakers to make up shortfalls by immediately shoring up the ailing Social Security Old-Age and Survivors Insurance (OASI) trust fund and the Social Security Disability trust fund (SSDI) by Congress increasing revenues or cutting costs to these programs.

“The theoretical combined trust funds will exhaust their reserves by 2034, when today’s 54-year-olds reach the full retirement age and today’s youngest retirees turn 75. Upon insolvency, all beneficiaries will face a 22% across-the-board benefit cut,” says a detailed analysis released by the Washington, DC-based Committee for a Responsible Federal Budget (CRFB), a non-partisan, nonprofit organization committee that addresses federal budget and fiscal issues.

According to this year’s Medicare Trustee’s report, there was no change from last year’s projections that noted Medicare Hospital Insurance trust funds would be deleted in 2026. If this occurs, physicians, acute care facilities and nursing homes would not receive their full compensation of the program (only 91% of scheduled payments), pushing the uncompensated costs on the patients to pay.

Total Medicare expenditures are projected to increase in the future at a faster pace than both total workers’ earnings and the overall economy, says the newly released Medicare Trustee report.

In light of the projected insolvency of Social Security, this year’s Trustee’s report notes that beneficiaries may receive an estimated 3.1% cost-of-living adjustment (COLA) for benefits in 2021, the highest COLA in a decade. This large increase was triggered by higher inflation rates caused by the ongoing pandemic.

Beltway Insiders Respond

“The Trustees’ projections in this year’s report include the best estimates of the effects of the COVID-19 pandemic on the Social Security program,” said Kilolo Kijakazi, Acting Commissioner of Social Security. “The pandemic and its economic impact have had an effect on Social Security’s Trust Funds, and the future course of the pandemic is still uncertain. Yet, Social Security will continue to play a critical role in the lives of 65 million beneficiaries and 176 million workers and their families during 2021.”

“The Trustees Report confirms that Social Security’s financing is strong in the near-term yet underscores why it is so important that Congress take action now to prevent 22% in cuts across the board on all benefits in 2034,” says House Ways and Means Social Security Subcommittee Chairman John B. Larson (D-CT) in a released statement. “With the loss of traditional pensions, rising health care costs, and many people unable to save enough for retirement, there is a growing retirement crisis. 65 million Americans currently rely on Social Security benefits, yet millions are suffering and can’t make ends meet, adds Larson.

Furthermore, the Trustees Report shows that this year the cost of paying out benefits will exceed the income from the Federal Insurance Contribution Act (FICA) payments,” states Larson.

The released 2021Trustee reports on the financial solvency of Medicare and Social Security trust funds once again identify unsustainable benefit promises in Medicare and Social Security programs, stated senator Mike Crapo (R-Idaho) said in a released statement.

 “The Hospital Insurance trust fund [Medicare] is projected to be exhausted around 2026; there are $60 trillion of unfunded liabilities in Social Security programs; and unfunded liabilities increased by trillions of dollars over the last year alone,” adds Crapo.

Crapo urges Congress and the White House to “work closely together with a sense of urgency to address the challenges detailed in the Social Security and Medicare Trustees Reports. However, “most Democrats want only to expand benefit promises further without generating sustainable trust fund solvency,” he said.

Seniors Depend on Social Security on Most of Their Income

“There is no need to sound the alarm, but now is the time to address Social Security’s long-term solvency – and provide an overdue boost in benefits. Phone calls and emails to Congress are definitely warranted at this critical juncture,” says Max Richtman, President and CEO of the Washington, DC-based National Committee to Preserve Social Security and Medicare, responding to the Social Security Trustee Report released August 31.

According to Richtman, Social Security has never missed a benefit payment in its 86-year history, but remains strong. Even if no Congressional action is taken and the Trust fund becomes deleted, Social Security could still pay 79% of the benefits with revenue coming from regular worker’s payroll contributions. “But that poses a huge financial risk for the millions of retirees who depend on Social Security for most if not all of their income.  It also raises a serious political risk for members of Congress who fail to boost the program’s finances so that the trust fund remains solvent beyond 2034,” he says. 

Living on an average monthly benefit of $1,540 is tough to do, says Richtman, as retirement savings dwindle, pensions disappear and the soaring cost of senior housing and medical care.  

Nancy Altman, President of Social Security Works (SSW) and chair of the Strengthen Social Security Coalition, agrees with Richtman’s assessment of Social Security’s fiscal solvency and impact on the retiree’s income. “Today’s report shows that Social Security remains strong and continues to work well, despite the once-in-a-century pandemic. That this year’s projections are so similar to last year’s proves once again that our Social Security system is built to withstand times of crisis, providing a source of certainty in uncertain times,” she says.

“We don’t have a Social Security crisis, but we do have a retirement income crisis — made worse by the pandemic, which, among other economic impacts, forced millions of workers to retire earlier than planned. The solution is to expand Social Security, as President Joe Biden has promised to do,” suggests Altman.

According to SSW, “about one out of two married senior beneficiaries and seven out of 10 unmarried senior beneficiaries and almost one out of tow unmarried beneficiaries rely on Social Security for virtually all their income.”

Mustering the Political Will 

Richtman calls for Congress to closely look at Congressman John Larson (D-CT) legislation to fix and expand the nation’s ailing Social Security program. “For over six years, Congressman John Larson has been driving efforts to strengthen Social Security by adjusting the payroll wage cap so that high income earners begin paying their fair share,” he notes.

Larson has also proposed an across-the-board boost for all retirees, enhanced benefits for the most vulnerable seniors, and a more accurate formula for calculating annual cost-of-living adjustments (COLAs) so that benefits truly keep pace with inflation, says Richtman, noting that the Connecticut Congressman’s  proposals also align with President Biden’s initiatives to strengthen and expand Social Security. 

“Of course, the default response from conservatives will be to suggest, indirectly or otherwise that Social Security benefits must be cut to address the program’s funding shortfall,” states Richtman said. “Some will insist that Social Security be privatized, which would gamble workers’ hard-earned retirement benefits on Wall Street. Meanwhile, conservatives likely will oppose common sense revenue-side measures that would actually boost benefits, including Rep. Larson’s proposed adjustment of the payroll wage cap.”  For Congress to act to advance legislation to strengthen and expand Social Security, voters must put political pressure on their elected officials “to muster the political will to get it done,” says Richtman.

A Final Note…

It’s better to make changes to ensure Social Security’s solvency now, rather than waiting, suggests CRFB, a delay only adds more costs to fixing trust fund shortfalls in a timely fashion.“ Acting now allows more policy options, lets policymakers phase in changes more gradually, and provides more time for workers to adjust their work and savings, if necessary,” the fiscal advocacy group says.

The clock is ticking. There are almost 4,500 days until the project insolvency of the Social Security trust fund. It is now time for Congress to find viable, bipartisan solutions to fixing Social Security and Medicare, once and for all. 

The 276-page 2021 Social Security Trust Fund report is available by going to https://www.ssa.gov/oact/TR/2021/tr2021.pdf.