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.

Medicare slow to fix equity issue for seniors’ access to at-home COVID test kits

Published on Feb. 7 in Rhode Island News Today

Today home test kits were made available in a variety of ways – but, for Medicare recipients, it was a different story, being forced to go thru a different purchasing and payment process than those having private insurance, or no insurance. That process required the oldest and most at-risk population to take more than several steps, put up their own money, do a lot of paperwork, to seek reimbursement.

The White House made changes in testing so that at-home tests are now fully covered by health insurances. Those insured can pick up their test kits in a store and have them paid for at the time of purchase by their insurance, at no cost to the person. They aren’t required to visit their physician or get a prescription to obtain the free test. They have a limit of 8 test kits per month.

But, when the program began, this was not the plan for those insured through the government’s Medicare and Medicare Advantage plans.

Red Tape… Upfront Charges for COVID-1

Jane, a 65-year old Medicare beneficiary from Warwick went through the steps to get a kit after a relative she had seen found out she was exposed to COVID.  Before Medicare announced easing up on the purchasing process of COVID-19 test kits, she expressed frustrations to this writer about the regulatory hoops she faced because she was on Medicare – purchasing the test kits and getting reimbursed for the upfront charges. “First, I had to request a prescription from my physician and say that I had either been exposed to someone who had COVID, or I was having symptoms, myself,” recalls the frustrated Medicare beneficiary.  “Once my physician sent the prescription over to CVS, I was notified that it would take a couple of days before I could pick up the kits and that I would only be given two kits per prescription”, she fumed, knowing that sometimes it takes 4 or 5 days of testing to test positive, but was only eligible to receive two, and she might have to go through the whole process again in a few days.

“Three days later CVS finally left me a message saying these kits were in. I used the drive-up window for pickup and the cashier asked me for $46,” Jane remembered.  “When questioning this charge, a pharmacist came to the window to assist and told me that I had to pay for the kits upfront and then seek reimbursement,” she added.

Paying for the kits, Jane went home, and called Blue Cross, her Medicare supplement company and was told she needed to request a copy of the prescription which took hours to finally request with the back and forth phone calls to her busy doctor’s office. It was almost two weeks later she finally got a copy of the receipt detailing her $46 payment for the kits. She was then able to upload the copy of the prescription and a copy of her receipt to a BCBS reimbursement screen on her computer (or she could have printed the form out and mailed the whole package in). At press time, Jane is still waiting for her reimbursement, being told it will take from 4 to 6 weeks to receive a check.

It’s better late than never, says Jane, when she heard that Medicare would now cover free over-the-counter COVID-19 tests. “Not everyone can put out $46 and wait two months to get it back, home health tests were made available in a variety of ways – but, for Medicare recipients, there was a different process. More concerning was all the steps I had to take to complete the process they had originally intended for us to do. How many people would really complete all those steps?” she says. “We talk a lot about equity, but seniors need equitable healthcare processes, too.”

Just days ago, the Centers for Medicare & Medicaid Services (CMS) announced that beneficiaries in either Original Medicare or Medicare Advantage will be able to get over-the-counter COVID-19 tests at no cost starting in early spring, estimated to be in April. Under the new CMS initiative, Medicare beneficiaries will be able to access up to eight over-the-counter COVID-19 tests per month for free. Tests will be available through eligible pharmacies and other participating entities. This policy will apply to COVID-19 over-the-counter tests approved or authorized by the U.S. Food and Drug Administration (FDA). A prescription will not be required.

CMS Unveils New Medicare Benefit

According to CMS, this new initiative will enable payment from Medicare directly to participating pharmacies and other participating entities to allow Medicare beneficiaries to pick up tests at no cost. This is the first time that Medicare has covered an over-the-counter test at no cost to beneficiaries.

CMS’s announcement follows last month’s announcement that the Biden-Harris Administration would be requiring commercial health insurance companies to cover at-home COVID tests for free.

Until the new benefit kicks in, Medicare beneficiaries can access free tests through a number of channels established by CMS, too. Now, they can request four free over-the-counter tests for home delivery at covidtests.gov. Or beneficiaries can access COVID-19 tests through health care providers at over 20,000 free testing sites nationwide. Many cities and towns are also giving out free test kits at drive-up handout programs as the state receives supplies.

CMS’s Feb. 3 statement noted that Medicare beneficiaries can also access lab-based PCR tests and antigen tests performed by a laboratory when the test is ordered by a physician, non-physician practitioner, pharmacist, or other authorized health care professional at no cost. In addition to accessing a COVID-19 lab test ordered by a health care professional, people with Medicare can also already access one lab-performed test without an order, also without cost sharing, during the public health emergency, says CMS.

In addition, CMS says that Medicare Advantage plans may offer coverage and payment for over-the-counter COVID-19 tests as a supplemental benefit in addition to covering Medicare Part A and Part B benefits. Medicare beneficiaries covered by Medicare Advantage should check with their plan to see if it includes such a benefit.

Finally, all Medicare beneficiaries with Part B are eligible for the new benefit, whether enrolled in a Medicare Advantage plan or not.

“AARP applauds today’s announcement that will guarantee access to at-home over-the-counter COVID-19 tests at no cost for Medicare’s 64 million beneficiaries and we thank [Health and Human Resources]Secretary Becerra and CMS Administrator Brooks-LaSure for their diligence in addressing this issue. Expanded access to no-cost testing will help protect seniors who have been hit hardest by the pandemic and ensure they can remain connected with their loved ones and community.,” says AARP Executive vice president and Chief Advocacy and Engagement Officer Nancy LeaMond in a statement issued with CMS’s Feb. 3rd announcement of the new Medicare benefit.

“Every American should have an easy way to get at-home COVID tests. We know that people 65 and older are at much greater risk of serious illness and death from this disease – they need equal access to tools that can help keep them safe. The cost of paying for tests and the time needed to find free testing options are barriers that could discourage Medicare beneficiaries from getting tested, leading to greater social isolation and continued spread of the virus, adds LeaMond.

Successfully Advocating the Seniors

Last month, Senators Sherrod Brown (D-OH) and Debbie Stabenow (D-MI) along with 17 of their  Senate colleagues including Rhode Island Democratic Senators Reed and Sheldon Whitehouse wrote to HHS Secretary Becerra and  CMS Administrator Brooks-LaSure urging them to expand Medicare coverage of free at-home rapid COVID-19 testing.

Aging groups also joined the Senators in pushing Medicare to offer the new testing kick benefit.  “It is clear that regular testing is a crucial part of managing the spread of COVID-19. That’s why AARP has been calling for coverage of at-home tests, says AARP’s LeaMond, noting that the nation’s largest aging advocacy group “will continue to watch for details about when and how at-home COVID tests are made available to those in Medicare.”

Thankfully CMS quickly heeded their calls.

For more information, please see these Frequently Asked Questions, https://www.cms.gov/files/document/covid-19-over-counter-otc-tests-medicare-frequently-asked-questions.pdf (PDF)

Stay tuned for free N95 masks to be made available to all coming up soon.

It’s time. Staff vaccinations required for nursing homes as 10 RI facilities see new COVID cases

Published in Rhode Island News Today on August 24, 2021

With the COVID-19 Delta variant spiking across the country especially among the unvaccinated, last Wednesday, President Joe Biden announced at an afternoon address at the White House that the U.S. Department of Health and Human Services will require nursing homes to require all workers to be fully vaccinated against COVID-19 as a condition for those facilities to continue receiving federal Medicare and Medicaid funding.

According to federal data, of the 1.6 million nursing home workers across the  nation, about 540,000 — 40 percent of the work force — are unvaccinated.  

Since the spread of the Delta variant, there has been a rise in the number of COVID-19 cases, especially in those states that have low rates of vaccinated workers. Both the U.S. Centers for Disease Control and Prevention (CDC) and Centers for Medicare & Medicaid Services (CMS) data confirm a strong relationship between the increase of COVID-19 cases among nursing home residents and the rate of vaccination among nursing home workers.

These new emergency federal regulations, crafted  by CDC and CMS, would apply to nearly 15,000 nursing home facilities, which employ approximately 1.6 million workers and serve approximately 1.3 million nursing home residents.

Rhode Island Gov. Dan J. McKee, along with other states, has already taken a similar step to protect nursing home residents by requiring all staff to be vaccinated and the new federal mandate will ensure consistent and equitable standards throughout the country. 

At a COVID-19 update held at the state the state capitol in early August, McKee called for the new vaccine mandate (as a term of employment) to take effect on Oct. 1st.

On August 23rd, Pfizer’s vaccine was fully approved by the FDA. Approvals of Moderna, Johnson & Johnson and booster shots are expected to follow soon.

According to CMS, the new mandate is a key component of protecting the health and safety of nursing home residents and staff by ensuring that all nursing home staff receive COVID-19 vaccinations. Over the past several months, millions of vaccinations have been administered to nursing home residents and staff, and these vaccines have shown to help prevent COVID-19 and have proven to be effective against the Delta variant.

“Keeping nursing home residents and staff safe is our priority. The data are clear that higher levels of staff vaccination are linked to fewer outbreaks among residents, many of whom are at an increased risk of infection, hospitalization, or death,” said CMS Administrator Chiquita Brooks-LaSure in a statement announcing the new vaccine mandate.  “We will continue to work closely with our partners at the CDC, long-term care associations, unions, and other stakeholders to advance policies that keep residents and staff safe. As we advance these new requirements, we’ll work with nursing homes to address staff and resident concerns with compassion and by following the science,” she said.

CMS says that it’s requiring all nursing home staff to be vaccinated is in keeping with the federal agency’s authority to establish requirements to ensure the health and safety of individuals receiving care from all providers and suppliers participating in the Medicare and Medicaid programs. About 62% of nursing home staff are currently vaccinated as of August 8 nationally, and vaccination among staff at the state level ranges from a high of 88% to a low of 44%. The emergence of the Delta variant in the United States has driven a rise in cases among nursing home residents from a low of 319 cases on June 27, to 2,696 cases on August 8, with many of the recent outbreaks occurring in facilities located in areas of the United States with the lowest staff vaccination rates.

Last May, CMS issued new regulations that require Long-Term Care (LTC) facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs/IID) to educate residents, clients, and staff about COVID-19 vaccination and, when available, offer a COVID-19 vaccine to these individuals. These regulations also mandate that LTC facilities report weekly COVID-19 vaccination data for residents and staff to the CDC’s National Healthcare Safety Network (NHSN).

CMS will continue to analyze vaccination data for residents and staff from the CDC’s National Healthcare Safety Network (NHSN) data as an additional method of compliance monitoring and in keeping with current practice, as well as deploy the Quality Improvement Organizations (QIOs)—operated under the Medicare Quality Improvement Program—to educate and engage nursing homes with low rates of vaccinations.

CMS strongly encourages nursing home residents and staff members to get vaccinated as the Agency undergoes the necessary steps in the rule-making process over the course of the next several weeks. CMS expects nursing home operators to act in the best interest of residents and their staff by complying with these new rules, which the Agency expects to issue next month.  CMS also expects nursing home operators to use all available resources to support employees in getting vaccinated, including employee education and vaccination clinics, as they work to meet this staff vaccination requirement.

Rhode Island Long Term Care Facilities with new cases in the last 14 days (as of 8/14/2020):

These RI nursing homes are on the RI Dept. of Health list with increased cases –

Alpine – Coventry – 5-9 cases

Avalone – Warwick – less than 5

St. Antoine – North Smithfield – less than 5

Woonsocket Health – Woonsocket – less than 5

All America Assisted Living – Warwick – less than 5

Anchor Bay – Johnston – less than 5

Smithfield Woods – Smithfield – less than 5

Sunrise House – Providence – less than 5

Bridge at Cherry Hill – Johnston – 5-9

Tockwotton – Providence – less than 5

AARP Strongly Supports Biden’s Vaccine Mandate in Nursing Homes 

In response to the Biden Administration directing all nursing homes that receive Medicare or Medicaid funds to require vaccinations for all staff, Nancy A. LeaMond, AARP Executive Vice President and Chief Advocacy & Engagement Officer, stated:  

“The Administration’s announcement today requiring vaccinations for nursing home staff is a significant step in the fight against this pandemic. Around 30% of COVID deaths have been among residents and staff in nursing homes and other long-term care facilities, even though they represent less than 1% of the population. As the new variants are emerging, facilities cannot let preventable problems be repeated. Increasing vaccination rates in nursing homes is one of the most common sense and powerful actions we can take to protect the lives of vulnerable older adults.”

The AARP Public Policy Institute, in collaboration with the Scripps Gerontology Center at Miami University in Ohio, created the dashboard to provide snapshots of the virus’ infiltration into nursing homes and impact on nursing home residents and staff, with the goal of identifying specific areas of concern at the national and state levels in a timely manner.

Don’t Just Single Out Nursing Homes 

“We appreciate the Administration’s efforts to increase COVID-19 vaccinations in long term care. Unfortunately, this action does not go far enough. The government should not single out one provider group for mandatory vaccinations. Vaccination mandates for health care personnel should be applied to all health care settings. Without this, nursing homes face a disastrous workforce challenge,” warns Mark Parkinson, president and CEO of the American Health Care Association and National Center for Assisted Living (AHCA/NCAL) 

“Focusing only on nursing homes will cause vaccine hesitant workers to flee to other health care providers and leave many centers without adequate staff to care for residents. It will make an already difficult workforce shortage even worse. The net effect of this action will be the opposite of its intent and will affect the ability to provide quality care to our residents. We look forward to working with the Administration in the coming days to develop solutions to overcome this challenge,” says Parkinson.

The full Nursing Home COVID-19 Dashboard is available at www.aarp.org/nursinghomedashboard. For more information on how COVID is impacting nursing homes and AARP’s advocacy on this issue, visit www.aarp.org/nursinghomes.