Tag Archives for CMS

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.

World issues pushed nursing home reform to the side in State of the Union. But it’s there

Published on March 7, 2022 in Rhode Island News Today

More than a week ago, President Joe Biden, with Vice President Kamala Harris and House Speaker Nancy Pelosi, sitting behind him in the House Chamber in the United States Capitol, delivered his first State of the Union Address. Harris and Pelosi made history marking the first time two women have been on the dais during a presidential address before the joint session and the American people

According to C-SPAN, Biden’s speech was the fourth-longest of the seven most recent presidents’ speeches, beating out Presidents George H.W. Bush, George H. Bush and Ronald Reagan. Amid frequent applause breaks, chanting from both sides of the aisle and heckling, Biden’s prepared remarks delivered Tuesday, March 1, 2022, totaled around 7,762 words, lasting over one hour and two minutes.

Biden spoke mostly on-script with his prepared remarks on a wide range of topics before lawmakers, Supreme Court Justices, guests, many waving small blue and yellow Ukraine flags or wearing the country’s colors to show solidarity with the people of Ukraine. While the first half touched on the Russian invasion of Ukraine and the need for a global coalition to respond, the second half addressed inflation, COVID-19 and the “new normal,” increasing domestic manufacturing, health care, prescription drugs, energy and taxes, voting rights legislation, and the nomination of Judge Ketanji Brown Jackson to the Supreme Court. 

Biden concluded his speech by proposing a “Unity agenda” calling for a fight against the opioid epidemic, pushing Congress to pass a mental health package, supporting Veterans returning from the battlegrounds of Iraq and Afghanistan and finding a cure for cancer.

The State of the Union and nursing homes

While Biden’s speech briefly touched on the quality of care in the nation’s nursing homes, his Administration is clearly making this a major domestic issue.  During the address, Biden expressed strong concerns about Wall Street firms that were taking over many nations’ nursing homes. “Quality in those homes has gone down and costs have gone up. That ends on my watch,” he told the packed chamber. “Medicare is going to set higher standards for nursing homes and make sure your loved ones get the care they deserve and expect and [they’ll be] looked at closely,” he said.

A day before the State of the Union address, the White house released a detailed document, entitled, “Fact Sheet: Protecting Seniors and People with Disabilities by Improving Safety and Quality of Care in the Nation’s Nursing Homes,” outlining dozens of proposed changes on how U.S. nursing homes are regulated and operate, including a vow to adopt federal minimum staffing requirements for facilities, step up enforcement of regulations and to eliminate overcrowded patient rooms.

Amid the ongoing COVID-19 pandemic that continues to wreak havoc on the nation’s nursing homes, where 200,000 residents and workers have died from COVID-19, nearly a quarter of all COVID-19 deaths in the United States, the Biden Administration says that staffing shortages are getting worse, reducing the quality of care provided to residents

Poorly performing facilities will be held accountable for improper and unsafe care and must immediately improve their services or will be cut off from tax payor dollars. Biden calls for better information to be provided to the public to assist them in better understanding the conditions they will find in each facility and to assist them in choosing the best care options available.  

Centers for Medicare & Medicaid Services (CMS) will begin to explore ways to reduce resident room crowding in nursing homes by phasing out rooms with three or more residents and promoting private, single occupancy rooms. Multi-occupancy rooms increase the risk of the spread of infectious diseases, including COVID-19.  The agency will also establish a minimum nursing home staffing requirement, the adequacy of staffing is closely linked to quality of care provided.

Meanwhile, CMS also plans to strengthen the Medicare Skilled Nursing Facility Value-Based Purchasing Program and base payment on staffing adequacy (including over weekends) and retention and the resident experience.  Although the nation has seen a dramatic decrease in the use of antipsychotic drugs in nursing homes in recent years, CMS will continue its efforts to identify problematic diagnoses and bring down “inappropriate use” of such drugs.

Enhancing accountability and oversight

The Biden Administration calls for the enhancing and accountability and oversight of the nation’s nursing homes by adequately funding inspection activities, beefing up scrutiny on more of the poorest facility performers, expanding financial penalties and other enforcement sanctions, and increasing the accountability for chain owners whose facilities provide substandard care. CMS will work with nursing homes to improve care by providing technical assistance.

To enhance transparency, CMS will create a new database that will track and identify owners and operators across states to highlight previous problems with promoting resident health and safety.  The agency will also collect and publicly report data on corporate nursing home ownership and will enhance the Nursing Home Care website. Finally, CMS will examine the role that private equity investors play in the nursing home sector.

Biden’s nursing home reforms will ensure that every nursing home has a sufficient number of adequately trained staff to provide care to the 1.4 million residents residing in over 15,500 Medicare and Medicaid facilities across the nation.  Nursing home staff turnover can be reduced by creating pathways to good-paying jobs along with ensuring staff to join a union.  CMS calls for lowering financial barriers to Nurse Assistant Training, adequate compensation and access to a realistic career ladder. The agency launches a National Nursing Career Pathways Campaign with partners including the Department of Labor.

Finally, Biden puts together his strategy to ensure emergency preparedness in nursing homes during the ongoing pandemic.  He calls for continued COVID-19 testing in nursing homes and continued COVID-19 vaccinations and boosters to be provided to residents and staff. CMS will strengthen requirements for on-site infection prevention, and make changes to its emergency preparedness requirements,   Finally, the agency will take what it has learned during the pandemic and integrate new lessons on standards of care into nursing home requirements around fire safety, infection control, and other areas, using an equity lens.

Point/Counter Point

In a released statement after Biden’s State of the Union address, AARP CEO Jo Ann Jenkins stated: “We were also encouraged to hear the President describe new actions to ensure that residents in nursing homes will receive the safe, high-quality care they deserve. For years, AARP and AARP Foundation have sounded the alarm about problems in America’s nursing homes. The COVID-19 pandemic exposed the chronic, ongoing issues with our long-term care system and emphasized the need for reform. It is a national disgrace that more than 200,000 residents and staff in nursing homes and other long-term care facilities died. AARP urges the federal government to act swiftly to ensure minimum staffing standards, increase transparency, and hold nursing homes accountable when they do not provide quality care.”

On the other hand, the nursing home industry had its views as to Biden’s call for nursing home reforms.  “The nursing home profession has always been committed to improving the quality of care our residents receive, and we appreciate the Biden Administration joining us in this ongoing effort. Over the last decade and prior to the pandemic, the sector made dramatic improvements. Fewer people were returning to the hospital, staff were providing more one-on-one care than ever before, and the unnecessary use of antipsychotic medications significantly declined,” said Mark Parkinson president and CEO of AHCA, in a released statement.

“Those who continue to criticize the nursing home sector are the same people who refuse to prioritize our residents and staff for resources that will help save and improve lives,” noted Parkinson, whose Washington, DC-based nonprofit organization represents more than 14,000 nursing homes and long-term care facilities across the nation. “Additional oversight without corresponding assistance will not improve resident care. To make real improvements, we need policymakers to prioritize investing in this chronically underfunded health care sector and support providers’ improvement on the metrics that matter for residents,” he said.

“It’s time to stop blaming nursing homes for a once-in-a-century pandemic that uniquely targeted our residents and vilifying the heroic caregivers who did everything they could to protect the residents they have come to know as family,” said Parkinson. ““Long term care was already dealing with a workforce shortage prior to COVID, and the pandemic exacerbated the crisis. We would love to hire more nurses and nurse aides to support the increasing needs of our residents. However, we cannot meet additional staffing requirements when we can’t find people to fill the open positions nor when we don’t have the resources to compete against other employers,” he said.  

To read the White House Fact Sheet to improving the quality of care in the nation’s nursing homes, go to:

https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/28/fact-sheet-protecting-seniors-and-people-with-disabilities-by-improving-safety-and-quality-of-care-in-the-nations-nursing-homes/

On Monday, March 7th at 9am, AARP Rhode Island and US Senators Reed and Whitehouse will speak on the need for lower prescription drug prices in a virtual press conference.

AARP Rhode Island State Director Catherine Taylor, Volunteer State President Marcus Mitchell and Volunteer Lead Federal Liaison Dr. Phil Zarlengo will join Rhode Island US Senators Jack Reed and Sheldon Whitehouse for a virtual news conference highlighting the need for Congress to lower prescription drug prices. AARP Rhode Island will present the Senators with a petition signed by more than16,000 Rhode Islanders calling for Congress to act now and stop unfair drug prices.

You can listen in via ZOOM at:  

https://aarp-org.zoom.us/j/98668832992?pwd=bktuTjJBMUZhUDRaVDkvN2dCSXZqUT09

Passcode: 618357

Participants will respond to on-topic media questions posted in chat.

More information about AARP’s Fair Drug Prices campaign can be found at aarp.org/rx.

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.