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.

AARP poll: women over 50 to decide control of congress, state capitols

Published in RINewsToday on April 11, 2022

It’s just 214 days until the upcoming midterm elections scheduled for Nov. 8, 2022, (Rhode Island’s primary is 167 days away scheduled for Sept. 13, 2022). During the 117th Congress, with a slim majority of 222 Democrats to 212 Republicans, the Democrats control the House chamber. When the dust settles after the election we’ll see if the Democrats retain their grip on this chamber. Washington insiders say that Senate Democrats, holding the majority with a 50-50 split with vice president Kamala Harris’ having a tie-breaking vote, could lose control of the upper chamber if the Republican Party flips seats. Thirty-five Senators are up for reelection.

Twenty Republican and 16 Democrat gubernatorial seats (including Rhode Island) are also up for grabs this election cycle, too.

A new AARP study finds that women voters aged 50 and over who haven’t decided which candidate to support will decide who controls Congress and state capitols across the nation in the next election.

Taking a Look at Older Women Voters

AARP’s  new research findings released April 6th, in partnership with pollsters Celinda Lake, Christine Matthews, Kristen Soltis Anderson, and Margie Omero, found that only 17% of women in this key voting bloc have made up their mind about who they will support in the upcoming 2022 elections. Not quite two-thirds (65%) of these voters say they will not make their decisions until weeks or even days before Election Day.

“Contrary to conventional wisdom, women voters aged 50 and over do not solidly belong in either party’s camp — and the vast majority haven’t made up their minds about how they’ll vote in November,” said Nancy LeaMond, AARP Chief Advocacy and Engagement Officer. “The instability and uncertainty of the economy, the pandemic, and the political environment are leading these women to demand that candidates address quality of life and pocketbook issues like the cost of living, supply chain problems, and ways to end the discord permeating politics today,” she says.

The pollsters found that the most important issues for r women voters aged 50 and over are “kitchen table budgets” and the “day-to-day experience of rising prices.” Nearly half of those surveyed (46%) see rising cost of living as the most important issue facing the nation today. And 59% say rising prices are the most important issue to them, personally, when reflecting about the economy.

According to AARP, women aged 50 and over are one of the largest, most reliable group of voters. According to voter file and census bureau data, they make up a little more than one-quarter (27%) of registered voters and cast nearly a third (30%) of all ballots in both the 2020 and 2018 elections.  In 2020, 83% of registered women voters in this age group turned out and in 2018, the last midterm election, they were 15% more likely to vote than the population at large, says the nation’s largest advocacy group.  

Concerns About Rising Costs and the Nation’s Economy 

AARP’s national survey also found that 72% of the woman respondents are concerned about having enough income to cover rising costs, with 48% saying they are very concerned. Fifty two percent say the economy is not working well for them, a 15-point change from 2019, when just 37% of women said the economy was not working well for them.

The pollsters found that most are not optimistic about their own financial futures in the next 12 months – with 47% saying they think their personal financial situation will stay the same, while 39% think it will get worse and only 13% think it will improve. The survey findings also indicated that those respondents age 50-64 are intensely worried about saving for retirement and their financial future – with 51% saying they are very concerned about Social Security being there for their retirement and 30% saying they are most concerned about having saved enough for retirement.  

According to the AARP survey, women voters aged 50 and over also expressed concern about political division in the country, and they are unimpressed with the job elected officials are doing on a range of issues, including their dominant concern of rising prices.

By more than a two-to-one margin, the pollsters say that these voters want politicians who are willing to work together to get things done, even if the result is an occasional compromise that goes against voters’ values (67%), over politicians who consistently fight for their values but don’t often find solutions (30%). This finding remains consistent across party identifications, with 77% of Democratic women and 57% of Republican women preferring a politician compromise to get things done, while 21% of Democratic women and 40% of Republican women prefer a values-prioritizing politician.

Taking a deeper look, the pollsters found that women voters 50 and over are divided evenly by party (44% R – 45% D), in sharp contrast to their male counterparts who are solidly Republican (51% R – 38% D).  In a generic ballot, the Democratic candidate for Congress (48% will vote for) has a 7-point advantage over the Republican candidate (41% will vote for) among these women voters.

Similar Observations from the Pollsters 

“Addressing the rising cost of living is an issue that any smart candidate for office will put front and center this year,” said Kristen Soltis Anderson, founding partner, Echelon Insights. “Especially in midterm elections, women voters aged 50 and over will be a critical group that both parties must compete for, and cost of living is clearly the top issue on which they want leaders to be focused,” she said.

Celinda Lake, founder and president, Lake Research Partners, agrees with Anderson that women aged 50 and over can be the significant voting bloc in the 2022 elections. “They are sure to turn out in high numbers when many other voters are disengaging. These voters have yet to make up their minds and are dissatisfied with the jobs their elected leaders are doing, especially on the kitchen table economic issues they face every day,” she notes.

“Women over 50 may not only be the decision-makers in their households, but they may also be the decision-makers of the midterm elections,” said Margie Omero, Principal at GBAO.

Christine Matthews, President of Bellwether Research, says“Women over 50 are arguably the most important voting cohort for the 2022 midterm elections – and they are not happy,” “They are extremely worried about the impact rising prices – particularly groceries – are having on their budget and their ability to save for retirement,” she says.

Matthew adds,” A majority say the economy is not working for them – a significant uptick from two years ago. They want politicians to work together to find solutions to inflation and other key issues, but they are not pleased with what they see. Elected officials should be prepared to demonstrate to this key group that they are working productively on cost-of-living issues,” she says.

The AARP national survey was conducted by phone and online from Feb. 18 to March 3, 2022, using 1,836 voters aged 50 and over who are likely to vote in 2022, with samples of Black voters, Hispanic/Latino voters, Asian American/Native Hawaiian and Pacific Islander voters, as well as American Indian/Alaska Native voters. 

A Final Note…

It’s just seven months before the upcoming midterm elections. The historical voting pattern of midterm elections is clear. “The sitting president’s party almost always loses House seats in the midterms. Going back to Harry Truman’s presidency, the president’s party has lost, on average, 29 House seats in each president’s first midterm election,” says James M. Lindsay, senior vice president, director of studies, and Maurice R. Greenberg chair at the Council on Foreign Relations, in a blog article, “The 2022 Midterm Congressional Elections by Number,” published on March 8, 2022.

Lindsay, senior vice president and director of studies and Maurice R. Greenberg chair, says, “The betting money is that the Republican Party will be the winner on election night, taking back control of one, if not both houses of Congress,” he says, noting that eight months can be a lifetime in politics. 

Republicans are optimistic in picking up seats because of Biden’s low job approval rating, inflation being at a 40-year high, 31 incumbent Democrats retiring (it’s more difficult to defeat an incumbent) and the COVID-19 pandemic still killing 1,500 American’s daily, says Lindsay. But Lindsay predicts Democrats may do better at the polls just because “the midterms are still eight months away,” and who knows where the country will be then. “The redistricting of House seats is going well for the Democrats with several states throwing out Republican redistricting plans and others enacting redistricting plans to benefit the Democrats, he says.

“The Senate math favors Democrats, the party just defending 14 seats while Republicans must keep 21 Senate seats,” adds Lindsay. “Ideologically extreme candidates” will push away moderate voters in House and Senate races, he says. 

But AARP’s national poll warning to Senators, House lawmakers, and Governors to not ignore the concerns of older women voters should be heeded. Not listening has a political cost. It may well determine the balance of power in the next election. 

Nursing Home Care in the Spotlight

Published in the Woonsocket Call on August 4, 2019

Following on the heels of its March 6 hearing, “Not Forgotten: Protecting Americans from Abuse and Neglect in Nursing Homes,” the Senate Finance Committee held its second nursing home hearing this year, “Promoting Elder Justice: A Call for Reform,” on July 23, in 215 Dirksen, to study proposed reforms to reduce neglect and abuse in the nation’s nursing homes and to put a spotlight on the need to reauthorize key provisions of the Elder Justice Act.

During the two hour and twenty-minute morning hearing, Chairman Chuck Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Oregon) along 11 members of the Senate committee listened to the testimony of five panel witnesses.

In his opening statement, Grassley acknowledged that the work isn’t done yet to improving the care in the nation’s nursing homes and Congress must protect nursing home and assisted living residents and those in group living arrangements from harm. The Iowa Senator noted in the recently released U.S. Government Accountability Office (GAO) report the federal agency that provides auditing, evaluation, and investigative services for Congress, noted that while one-third of nursing home residents may experience harm while under the care of these facilities, in more than half of these cases, the harm was preventable.

Calls for Bipartisan Efforts to Improve Nursing Home Care

Grassley called on Congress to reauthorize programs, such as the Elder Justice Act, to put the brakes on the growing trend of elder an abuse fueled by social media.

Adds, Wyden, in his opening statement, there is now an opportunity for Congress to come together to hammer out bipartisan legislative reforms to fix the nation’s nursing home oversight efforts. He urged his fellow Senate committee members to work to reduce the instances of physical, sexual, mental and emotion abuse in nursing homes, that appears to be increasing. He also called for a redo to the federal nursing home rating system because it does not reflect the increased prevalence of abuse.

During the first panel, Megan H. Tucker, Senior Advisor for Legal Review, of the HHS Office of Inspector General (OIG), stated that abuse and neglect oftentimes are not properly identified, reported or even addressed. While most providers are delivering good care, Tucker warned that Health and Human Service safeguards are lacking.

Tucker testified that the Centers for Medicare and Medicaid Services (CMS) should use data more effectively and close the gaps in their reporting process to ensure that abuse and neglect are identified and the deficiencies corrected.

Concluding the first panel, John E. Dicken, Director, Health Care, of the U.S. Government Accounting Office (GAO), discussed a newly released GAO report, released at the hearing, that detailed a growing trend of abuse and neglect of residents. According to one GAO report findings, abuse deficiencies more than doubled between 2013 (430) and 2017 (875), with the greatest increase in actual harm and immediate jeopardy deficiencies, and that abuse is still under-reported, he said. The GAO report also expressed concern over “significant gaps” with CMS’s oversight.

Leading the second panel, Robert Blancato, Coordinator of the Elder Justice Coalition, called on Congress to reauthorize, the Elder Justice Act. With elder abuse becoming a “national emergency,” he urged lawmakers to dedicate funding for Adult Protective Services at the local and state levels. Blancato also stressed the importance of strengthening the long-term care ombudsman program, continuing the Elder Justice Coordinating Council, authorizing an Advisory Board on Elder Abuse, Neglect, and Exploitation, and finally funding for elder abuse forensic centers.

President and CEO, Mark Parkinson, of the Washington, DC-based American Health Care Association (AHCA), representing nearly 10,000 of the 15,000 plus nursing homes in the country who provide care to nearly four million individuals each year, stated he was not at the hearing to defend poor care but to provide solutions to Congress to prevent such incidents from happening again.

Fixing the Problem

Parkinson testified that over the past seven years, facilities participating in AHCA’s quality initiative, have shown improvement in 18 of 24 quality measures. Specifically, there are less hospital readmissions, fewer antipsychotic medications being prescribed, staff are spending more time than ever before with residents and today’s nursing homes are more person-centered care today than ever before.

Parkinson called on lawmakers to improve employee background check systems, add patient satisfaction data to CMS’s nursing home rating system, address the severe staffing shortage and to adequate fund Medicaid.

Finally, Lori Smetanka, Executive Director of the National Consumer Voice for Quality Long-Term Care, ended the second panel discussions, by warning that more must be done to protect nursing home residents from abuse.

Smetanka urged Congress to take steps to enforce minimum requirements for sufficient staffing, establish standards and oversight for nursing home ownership and operations, prevent rollback of nursing home regulatory standards, increase the transparency of information and to strengthen and adequately fund elder justice provisions.

Now, with the Congress putting poor nursing home care on its policy radar screen, both Democratic and Republic congressional leadership must work closely together to come up with bipartisan solutions. Fix this problem once and for all.

Senate Finance Committee members — Senators Lankford, Stabenow, Daines, Menendez, Carper, Cardin, Warner, Casey, Brown, Cortez Masto, and Hassan – attended the July 23 hearing

To listen to this Senate Finance Committee hearing, go to http://www.c-span.org/video/?462733-1/finance.

For a copy of the GAO report, http://www.gao.gov/assets/710/700418.pdf.