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.

Bill Protects Nursing Home Residents, Providers

Published in the Pawtucket Times on June 1, 2020

This month, U.S. Senator Bob Casey (D-PA) and Senator Sheldon Whitehouse (D-RI) throw a bill in the legislative hopper to slow the spread of novel coronavirus (COVID-19) in nursing homes. It’s a common-sense legislative proposal and needed.

A recently released Kaiser Family Foundation study reported, “COVID-19 has had a disproportionate effect on people who reside or work in long-term care facilities, including the 1.3 million individuals in nursing homes; 800,000 in assisted living facilities; 75,000 in intermediate care facilities; and 3 million people who work in skilled nursing or residential care facilities.”

Combatting COVID-19 in Congregate Settings

With COVID-19 quickly spreading throughout the nation’s nursing homes and intermediate care facilities, Casey and Whitehouse’s legislative proposal, S. 3768, The Nursing Home COVID-19 Protection and Prevention Act, seeks to provide needed resources to facilities to protect frail residents and staff. Residents in these facilities are among the most vulnerable because of their age and underlying medical conditions. According to an analysis conducted by Gregg Girvan for the Foundation for Research on Equal Opportunity, as of May 22, in the 39 states that currently report such figures, 43 percent of all COVID-19 deaths have taken place in nursing homes and assisted living facilities

As more than 20,000 nursing homes residents and workers have died due to COVID-19, according to the latest reports, on May 19, 2020, Casey and Whitehouse introduced S.3768 to help states, nursing homes and intermediate care facilities put the brakes on the spreading of the deadly COVID-19. The legislative proposal, with 14 Democratic cosponsors (including Rhode Island Senator Jack Reed}, would help states implement strategies to reduce the spread of COVID-19 in congregate settings, including through the purchase of personal protective equipment (PPE) and testing and to support nursing home workers with premium pay, overtime and other essential benefits.

S. 3768 was referred to Senate Health, Education, Labor, and Pensions. As of March 30, 2020, a Congressional Budget Office cost estimate or this measure has not been received.

Days after the introduction of 25-page Senate legislative proposal, a House version (H.R. 6972) was introduced by Rep. Ana G. Eshoo (D-CA), cosponsored by Reps. Janice D. Schakowsky (D-IL), Donna E. Shalala (D-FL), Madeleine Dean (D-PA), Seth Moulton (D-MA) and David N. Cicilline (D-RI). The House bill was referred to House Energy and Commerce

“This virus spares no state, no county, no facility. The unprecedented crisis unfolding in our Nation’s nursing homes demands an immediate, extraordinary response. Reports indicate nursing home residents and workers account for roughly 1 in 4 deaths from COVID-19 in the United States,” said Casey, who serves as Ranking Member of the U.S Senate Special Committee on Aging, in a statement announcing the bill’s introduction. “The Nursing Home COVID-19 Protection and Prevention Act would provide $20 billion in emergency funding [for staffing, testing, Personal Protective Equipment, etc.] to devise a sorely needed national, coordinated response to stem the spread of this terrible virus in nursing homes and intermediate care facilities,” notes Casey.

According to Casey, the Senate bill would also require the U.S. Department of Health and Human Services (HHS) to develop guidance on cohorting best practices, including on how to safeguard resident rights. It would also instruct HHS to collect and publish data on COVID-19 cases and deaths in nursing homes and intermediate care facilities, and finally fund surge teams of nurses, aides, and other critical staff to fill in at facilities where multiple residents and staff members have been infected.

“COVID-19 poses an immediate threat to the more than 1.3 million Americans, including more than 7,000 Rhode Islanders, who live in nursing homes,” says Whitehouse, noting that frontline staff across the nation are “doing heroic work under very challenging circumstances.”

“We need to get vastly more personal protective equipment and tests to nursing homes, which care for the patients who are most vulnerable to the coronavirus. Our legislation would also help states fund surge teams, sending additional staff reinforcements to facilities where they are needed to care for patients and prevent infection,” adds Whitehouse.

Before S. 3768 was officially introduced, in early March, Washington, DC-based AARP announced its support for the Senate proposal. “AARP supports the draft of the Nursing Home COVID-19 Protection and Prevention Act that would help protect the health and save the lives of people in nursing homes and other facilities by supporting testing, personal protective equipment, staffing and more,” said Megan O’Reilly, Vice President of Government Affairs for AARP. “The proposal would also improve public transparency and help protect the rights of residents and their families, adds O’Reilly, calling on Congress “to act immediately to stem the loss of life and slow the spread of the virus.”

In the House Chamber, Rhode Island’s Cicilline, a member of the House Democratic Leadership as Chair of the Democratic Policy and Communications Committee, has also pushed for Congressional funding to stop the spread of COVID-19 in nursing homes. The fifth term Congressman has called for additional funding for the Public Health and Social Services Emergency Fund in the next package for congregate care facilities, including nursing homes. He also signed a letter to HHS Secretary Azar and Administrator Verma, of the Centers for Medicare and Medicaid Services (CMS), urging that HHS and the CMS to ensure that a significant portion of the newly allocated $25 billion for testing in the recently passed CARES Act be utilized for testing in nursing homes and other congregate living facilities.

State-wide Efforts to Combat COVID-19 in Nursing Homes

With Governor Gina Raimondo declaring a state of emergency on March 9, 2020, with the COVID-19 arriving in Rhode Island, the deadly pandemic virus spread quickly throughout the state’s nursing homes. At press time, it has been reported that 75 percent of all related COVID-19 deaths are in nursing homes.

According to Joseph Wendelken, Public Information’s Officer for the Rhode Island Department of Health (RIDOH), the state moved quickly to stop the spread of the COVID-19 virus in the community and in nursing homes. He stated: “We curtailed and then prohibited visiting early on, and we have been doing extensive testing in every assisted living facility in the state. We are doing cyclical testing, meaning that we are continually testing all residents in all homes on a rotating basis. We are giving tailored infection control guidance to specific homes, and we are helping them procure additional PPE.”

Adds Wendelken, RIDOH has established two COVID-19 Specialty Nursing Homes [at Oak Hill Center in Pawtucket and Oakland Grove Health Care Center in Woonsocket] to be a COVID-19 Specialty Nursing Home. “These are centralized facilities to accept patients who are being discharged from the hospital and who are COVID-19 positive but no longer require acute-level care. This strategy allows COVID-19 positive patients leaving the hospital to receive specialized rehabilitation and step-down, post-acute care while reserving hospital beds for patients who need acute-level care,” he said.

On Smith Hill, the Rhode Island House Republican Caucus has recently called for members of the House Committee on Oversight to meet to address the increasing COVID-19 death rate in the state’s nursing and assisted living facilities.

Putting Politics Aside…

With less than 156 days until the upcoming 2020 Presidential election, will S. 3768 reach the Senate floor for a vote. Since the beginning of 2019, more than 350 House-passed bills—including hundreds that have bipartisan support—have been buried by Senate Majority Leader Mitch McConnell (R-Kentucky) in his legislative graveyard. With no Republican Senators supporting Casey and Whitehouse’s COVID-19 bill, will it even reach the Senate floor for a vote?

It’s time for McConnell, who has called himself the “grim reaper” of Democratic legislation, to lay down his deadly scythe, making the safety of millions of residents who reside in the nation’s 15,583 skilled nursing facilities a legislative priority. The GOP Senator from Kentucky, who is in a close Senate race with Democratic opponent Amy McGrath, might consider putting politics aside during a raging COVID-19 pandemic sweeping across the nation to work with Senate Democrats to protect frail residents and nursing home staff. Kentucky voters might view protecting residents against COVID a bipartisan issue.

Senators Seek to Identify Subpar Nursing Homes

Published in the Woonsocket Call on July 14, 2019

Last month, U.S. Senators Bob Casey (D-PA) and Pat Toomey (R-PA) succeeded in prodding the Centers for Medicare and Medicaid Services (CMS) to publicly release the April listing of underperforming nursing homes across the nation that require closer regulatory scrutiny but are not receiving any. Before CMS released the listing of candidates to the Special Focus Facility (SFF) program, the federal agency, charged with overseeing the care and quality in nursing homes, had not publicly identified these troubled facilities.

Less than 6 percent (88 facilities) out of more than 15,700 nursing homes nationwide are participants of the SFF program. CMS publicly identifies these facilities to the public. But an additional 2.5 percent (or approximately 400 facilities) qualify as candidates for the program because of having a “persistent record of poor care” but are not selected because of limited resources at CMS, according to a 26-page report, “Families’ and Resident’s Right to Know: Uncovering poor care in America’s Nursing Homes,” released in June 2019 by Pennsylvania’s two U. S. senators.

Nursing homes that are part of the SFF program have 12 to 18 months to correct any deficiencies and have two clean CMS surveys. If a facility fails to meet that target, it is are subject to increased regulatory enforcement, including being dropped from the Medicare and Medicaid programs.

Calls for Transparency

On March 4, 2019, Casey and Toomey wrote to CMS requesting information on its oversight of nursing homes in the SFF program. In that letter, the Senators requested the federal agency to provide the names of the 400 SFF candidates, calling for details about programs operations, scope and overall effectiveness. On May 3, 2019, CMS provided a written response and two weeks later, on May 14, the Senators received the listing of SFF candidates for April 2019. The names of these SFF candidates were not made public until Cassy and Toomey forced the issue by releasing this information in their report on June 5.

In CMS administrator Seema Verna’s May 14 letter to the two senators, Rhode Island-based participants and candidates in the SFF program were identified. They are: Charlesgate Nursing Center (SFF Candidate); Hebert Nursing Home (SFF Candidate); Oak Hill & Rehabilitation Center (SFF); St. Elizabeth Manor East Bay (SFF Candidate); and Tockwotton on the Waterfront (SFF Candidate).

In responding to the senators, Verma said that regardless of whether a nursing home is part of the SFF program, “any facility that performs poorly on surveys and continues to jeopardize residents’ health and safety will be subject to CMS enforcement,” which includes civil money penalties, denial of payment for new admissions or termination from the Medicare and Medicaid programs. Verma also stressed that in addition to her agency’s regulatory oversight, its Nursing Home Compare website has been improved to include “new, more reliable sources for obtaining staffing and resident census data, as well as including more claims-based quality measures.”

“Regardless of participation in the SFF program, any facility that performs poorly on surveys and continues to jeopardize residents’ health and safety will be subject to CMS enforcement remedies, such as civil money penalties, denial of payment f-or new admissions, or termination,” adds Verma.

Casey and Toomey believe that the list of SFF candidates is information that must be publicly available to individuals and families seeking nursing care for their loved ones. For that reason, the Senators have released the April 2019 list of SFF candidates and are continuing to work with CMS to make future lists public.

Through the release of the SFF candidate list and the Senate report, which details preliminary findings from surveys and public information about these candidate facilities, the Senators aim to provide Americans and their families with the transparency and information needed to choose a nursing home that would provide quality care to a loved one.

CMS Inquiry Identifies Issues

Casey and Toomey’s CMS inquiry into the SFF program put the spotlight on several issues. It became apparent to the two senators that a nursing home’s participation in the SFF program was not easily understandable to the public or would-be residents and their families. It became clear that CMS’s Nursing Home Compare, the agency’s online website, was not consistently updated to reflect any changes in the SFF program. “For example, in March 2019, the small icon used to indicate that a facility is an SFF participant was not on the webpage of five of the 17 newly-added SFF participants,” noted the Senate report. Most important, CMS’ website did not identify SFF candidates.

According to the released Senate report, only CMS and the state regulatory agency in which the nursing home is located and the facility itself, had knowledge of who is an SFF candidate. While CMS requires every nursing home to notify residents and its community of its regulatory SFF participant designation, these requirements do not apply to SFF candidates.

Aside from CMS recently updating its Nursing Home Compare webpage to more clearly indicate which nursing homes are SFF participants, it lacks details about the SFF program. There is no information explaining the reason for a facility’s participation in the program, the length of time it has been in the program or whether it has fixed the care issue. Most important, CMS does not include information on facilities that routinely cycle in and out of the SFF program, says the Senate report.

“There are few decisions more serious or life-altering than that of choosing a nursing home. I am pleased that CMS has taken the work that I have done with Senator Toomey seriously and is heeding our call to release the list of nursing facilities that are nominated to the Special Focus Facility program,” said Casey. “Our bipartisan work will ensure that families have all the information at their fingertips when choosing a nursing home. Now we must work in a bipartisan fashion to ensure the SFF program is working properly and that CMS has the funding it needs to improve underperforming nursing homes nationwide,” he says.

Adds, Toomey, “Ensuring that families have all the information they need about a nursing home will improve the quality of care at facilities across the country.”