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.

A Sacred Trust – moves to strengthen Social Security

Published on November 8, 2021 in RINewsToday

Almost two weeks ago, House Ways and Means Social Security Subcommittee Chairperson John B. Larson (D-Conn.) threw H.R. 5723, the Social Security 2100: A Sacred Trust, into the legislative hopper. During its unveiling in the historic committee room of the House Ways and Means Social Security subcommittee, the same room where Social Security and Medicare legislation was crafted in the 1930s and 1960, the Connecticut Congressman’s proposal comes on the heels of the Social Security Administration’s 2021 estimate that the trust funds that support the program will be depleted in just 13 years, averting an estimated 20 percent cut in benefits by 2034.

The Sacred Trust Act is the successor to Larson’s original Social Security 2100 Act, which he first introduced in 2014.The House Ways and Means Committee is planning to hold a hearing on the bill in Nov. followed by a markup.

At press time, 194 House Democratic Members are cosponsoring the 100-page House Democratic proposal with no Republican lawmakers crossing the aisle. Almost 40 advocacy groups are endorsing the House Democratic proposal.

At the Oct. 26 news conference unveiling Larson’s legislative proposal, the Connecticut congressman noted that Congress expanded Social Security during the past 50 years and it has been 38 years since lawmakers have taken any comprehensive action to strengthen the program.“ With 10,000 Baby Boomers a day becoming eligible, and with millennials needing Social Security more than any generation, the time for Congress to act is now,” he said.

Taking a Close look at H.R. 5723

According to the legislative fact sheet released at the news conference, H.R. 5723 gives a benefit bump for current and new Social Security beneficiaries. It provides an increase for all beneficiaries (receiving retirement, disability or dependent benefits) equivalent to an average of 2% of benefits to make up for inadequate Cost-of-Living Adjustments (COLA) since 1983.

Larson’s Social Security proposal also protects Social Security beneficiaries against inflation. It improves the annual COLA formula by adopting a Consumer Price Index for the Elderly (CPI-E), to better reflect the costs incurred by seniors who spend a greater portion of their income on health care and other necessities. Although the 2022 COLA 5.9%, the largest in years, the average for the past 10 years is roughly 1.5% and in 3 of the past 12 years, beneficiaries received no COLA at all.

It protects low-income works that provides a new minimum benefit stet at 25% above the poverty line and would be tied to wage levels to ensure that minimum benefits doe not fall behind. Currently, 5 million seniors live in poverty.

The Sacred Trust Act also contains other provisions that seniors and their advocates have sought for years, including:

Improving Social Security benefits for widows and widowers in two income households so they are not penalized for having two incomes.
Ending five-month waiting period to receive disability benefits so those with ALS or other severe disabilities no longer have to wait.
Providing caregiver credits for Social Security wages to ensure that caregivers are not penalized in retirement for taking timeout of the workforce to care for children and other dependents.
Extending Social Security benefits for students to age 26 and for part-time students.
Increasing access to Social Security dependents for children who live with grandparents or other relatives.
Requiring Social Security Administration (SSA) to mail annual statements to all workers detailing the FICA contributions they make and projects of their benefits in the future.
Preventing unwarranted closures of SSA offices to improve customer serve
Improving access to legal representation for people seeking long-term disability benefits.

H.R. 5723 would pay for strengthening the Social Security Trust Fund by having millionaires and billionaires pay the same rate as everyone else.Currently, payroll taxes are not collected on an individual wages over $142,800.The legislative proposal would apply payroll taxes to wages above $400,00.This provision would only impact the top 0.04% of wage earners.

Larson’s proposal would also extend the solvency of Social Security by making a significant contribution to the programs solvency, making up more than half of the shortfall in the Social Security Trust Funds.

Finally, H.R. 5723 would combine the Old-Age and Survivors Insurance with Disability Insurance into one Social Security Trust Fund, to ensure all benefits will be paid.

It’s Now Time to Fix Social Security

Larson’s Social Security proposal would “take historic steps to expand Social Security — delivering for retirees, people with disabilities, and their families the first real boost in benefits in 50 years. The Sacred Trust Act also would bring new revenue into Social Security amid projections that the trust fund will run dry in 2034 if Congress doesn’t take action,” says Max Richtman, President and CEO of the Washington, DC-based National Committee to Preserve Social Security and Medicare.

“To those who claim that no one in Washington has the courage to address Social Security’s challenges, or that the only solution is to cut benefits for future generations, Congressman Larson’s bill is a stunning refutation,” states Richtman, noting that he understands that beneficiaries need an increase in monthly checks to meet skyrocketing living expenses. “He knows that the fairest way to strengthen Social Security’s finances is for the wealthy to begin paying their fair share of payroll contributions. For years, seniors and their advocates have demanded these improvements,” adds Richtman.

“There is good news for everyone in this bill, which is only fitting, since Social Security touches almost every American’s life. Beneficiaries have waited long enough for these vital improvements. Congressman Larson now has nearly 200 cosponsorsin the House. After seven long years, seniors and their advocates can finally see the finish line, says Richtman.

With the Democrats controlling the White House, seniors have a good chance of seeing the expansion and strengthening of Social Security. The proposal has many of President Biden’s promises made during his campaign. But, like Larson’s previous Social Security Bill, the latest version has no Republican cosigners.

Over the years, poll after poll has shown that the American public strongly supports Social Security, across party and demographic lines. Larson’s legislative proposal has the support in the House, but will it pass in the upper chamber with Senate Democrats holding a slim majority? Will voter support influence Republican lawmakers to work across the aisle with Democrats to hammer out an acceptable bipartisan proposal, as the 2022 mid-term elections get closer? We’ll just have to wait and see.

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.