Tag Archives for Centers for Medicare and Medicaid Services

Medicare to negotiate select drug prices with Big Pharma, lists first 10 drugs

Published in RINewsToday on September 4, 2023

While critics are attempting to go through the courts to put the brakes on allowing Medicare to negotiate and set drug prices, last week, the Biden administration announced its list of 10 drugs that will be subject to price negotiations mandated by the Inflation Reduction Act (IRA).  

Earlier this month, more than 70 groups and a petition signed by 150,000 individuals called on Merck & Co., Bristol Myers Squibb Company, Janssen Pharmaceuticals, Astellas Pharma US, Pharmaceutical Research and Manufacturers of America (PhRMA) and the U.S. Chamber of Commerce, to drop their lawsuits to block the drug price negotiation provisions from taking place, and several organizations filed an amicus brief in support of the Biden administration’s historic law. 

With President Biden signing the IRA into law in Aug. 2022, the Centers for Medicare and Medicaid Services (CMS) began hammering out the regulations by issuing on March 15, 2023 its initial guidance for its Medicare Drug Price Negotiation Program. At that time, CMS had received over 7,500 comments on its initial guidance from consumer and patient groups, drug companies and pharmacies.  On June 30, 2023, the federal agency released its revised guidance detailing the requirements and parameters for the program. With the publishing of the listing of 10 drugs on August 29, 2023, for the first time, Medicare is now able to move forward in negotiating prices directly with drug companies, with the goal of lowering prices on some of the costliest prescription drugs. 

According to CMS, the selected 10 drugs accounted for $50.5 billion in total Part D gross covered prescription drug costs, or about 20%, of total Part D gross covered prescription drug costs between June 1, 2022, and May 31, 2023, which is the time period used to determine which drugs were eligible for negotiation. The negotiations with participating drug companies begin now until 2024, and any negotiated prices will become effective beginning in 2026. Medicare beneficiaries taking the 10 drugs covered under Part D selected for negotiation paid a total of $3.4 billion in out-of-pocket costs in 2022 for these drugs.

It’s a Long Wait…Lower Prices to Take Effect Jan. 2026

CMS will publish any agreed-upon negotiated prices for the selected drugs by September 1, 2024; those prices will come into effect starting January 1, 2026. In future years, CMS will select for negotiation up to 15 more drugs covered under Part D for 2027, up to 15 more drugs for 2028 (including drugs covered under Part B and Part D), and up to 20 more drugs for each year after that, as outlined in the IRA.  CMS will provide opportunities for public comment at patient-focused listening sessions in Fall 2023.

“For far too long, pharmaceutical companies have made record profits while American families were saddled with record prices and unable to afford life-saving prescription drugs,” says Secretary Xavier Becerra, of the U.S. Department of Health and Human Services (HHS). “Although drug companies are attempting to block Medicare from being able to negotiate for better drug prices, we will not be deterred,” she pledges. 

With the announcement of the first drugs selected for Medicare drug price negotiation, CMS Administrator Chiquita Brooks-LaSure noted it marked a significant and historic moment for the Medicare program. ”Our goal with these negotiations is to improve access to some of the costliest drugs for millions of people with Medicare while driving competition and innovation,” she said.

Adds Meena Seshamani, MD, PhD, CMS’s Deputy Administrator and Director of the Center for Medicare, “Promoting transparency and engagement continue to be at the core of how we are implementing the new drug law and the Medicare Drug Price Negotiation Program, and that is why we set out a process for the first round of negotiation that engages the public throughout.” 

“No one should have to choose between paying for lifesaving medication and other basic necessities, like food and housing,” says Rep. Seth Magaziner, representing Rhode Island’s Congressional District 2.  Nearly 191,000 Rhode Islanders are enrolled in Medicare Part D and could be eligible for cost savings that results from CMS’s negotiating with drug makers, he says, noting that.  Rhode Island seniors paid an average of $6,022 in out-of-pocket costs per year for one of the drugs selected for Medicare Price Negotiations.  These drugs are used to treat some of the most common diseases like diabetes, heart disease, arthritis, blood clots, and cancers.   

But PhRMA and U.S. Chamber of Commerce express strong concerns over imposing government price controls on the price of medications.  

CMS’s release of 10 drugs selected for negotiation “is the result of a rushed process focused on short-term political gain rather than what is best for patients,” says PhRMA) President and CEO Stephen J. Ubl. “Many of the medicines selected for price setting already have significant rebates and discounts due to the robust private market negotiation that occurs in the Part D program today,” he claims.

“Giving a single government agency the power to arbitrarily set the price of medicines with little accountability, oversight or input from patients and their doctors will have significant negative consequences long after this administration is gone,” warns Ubl.

Furthermore, “insurance companies and their Pharmacy Benefit Managers may further restrict access to medicines through increased utilization management, higher copays and more restrictive formularies, notes Ubl.

USCoC also expresses strong concerns over HHS’s move to impose government price controls on medications. While USCoC is supportive of affordable medications, it warns that an implementing government price controls scheme is both “counterproductive and will restrict access to critical medicines, delay treatment for patients, and jeopardize the search for new lifesaving cures,” says Executive Vice President and Chief Policy Officer Neil Bradley. 

“In its rush to implement the IRA’s price control scheme, the Biden administration failed to examine the likely negative side effects of the policy, charges Bradley.

Celebrating a Sweet Victory

“The negotiated drugs list is a watershed moment for medicine affordability. Drug corporations pretend this is a catastrophe, but I would rather see that money in seniors’ pockets than Big Pharma’s,”  says Peter Maybarduk, director of the Access to Medicines program at Public Citizen

“Drug corporations, in crude arrogance, are suing to limit price negotiations under the IRA. But the list shows instead how important it is to expand those negotiation powers. Several monopolized drugs that are expensive for Medicare today are exempted from price negotiation, and will remain expensive,” predicts Maybarduk, explaining that for a many-years long grace period after a drug first comes to market. “During those years, drug makers will exploit patent monopolies with minimal checks on profiteering. That profiteering period is even longer for biologics, which comprise some of the most exorbitantly priced drugs,” he says. 

“This is an historic day in the effort to lower prescription drug prices for seniors.  The Biden administration has released the names of the 10 life-saving drugs that will be subject — for the first time ever — to price negotiation between Medicare and Big Pharma,” stated Max Richtman, President and CEO, National Committee to Preserve Social Security and Medicare.

According to Richtman, the Inflation Reduction Act provides for this reform, in addition to a $2,000 out-of-pocket cap for patients’ Medicare Part D drug costs and penalties for drug-makers who hike prices above the rate of inflation. Medicare price negotiation alone is expected to save seniors and taxpayers billions of dollars in drug costs over next the decade.

“This is a sea change in the government’s ability to lower prescription drug prices for older Americans, who all too often are compelled to ration medications or forgo filling prescriptions because of soaring costs. NCPSSM has fought for Medicare to be empowered to negotiate prices for some twenty years now,” adds Richtman., noting that the next step is to enlarge the number and type of medications subject to negotiation, to deliver maximum relief to seniors on fixed incomes.   

“Allowing Medicare to negotiate prices for these first 10 drugs will finally bring much needed access and relief to American families, particularly older adults. We cannot overstate how monumental this law is for older Americans’ financial stability and overall health, said AARP Executive Vice President and Chief Advocacy and Engagement Officer Nancy LeaMond. 

“The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore. AARP will keep fighting to protect Medicare negotiation from any efforts to undo or weaken it, so all older Americans can afford their lifesaving medicines,” Says LeaMond.

And Alex Lawson, Executive Director of Social Security Works, says CMS’s listing of 10 drugs are among the most outrageously priced drugs on the market, calling these drugs, “Pharma’s prized cash cows.”

“This is just the beginning,” says Lawson, predicting that within a decade, Medicare will have the power to negotiate lower prices on well over 100 drugs. “That’s a huge win for seniors and people with disabilities,” she adds, noting that it is the biggest legislative defeat Big Pharma has ever suffered – and it won’t be the last.

Final Note…

Vincent Marzullo, who serves on the Board of the Senior Agenda Coalition of RI as well as a member of Congressman Magaziner’s Senior Advisory Committee, says that despite CMS’s  announcement of the 10 drugs to be negotiated, consumers won’t realize a penny in savings until January 2026, 28 months from now. “Unfortunately, urgency seems not to be a feature of the Inflation Reduction Act at least when we will get lower priced prescriptions,” he says.

View a fact sheet from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) at: https://aspe.hhs.gov/sites/default/files/documents/705b9c384d493e442a1d4004905cf8ae/ASPE-IRA-Drug-Negotiation-Fact-Sheet.pdf.

More information on the Medicare Drug Price Negotiation Program is available at https://www.cms.gov/inflation-reduction-act-and-medicare/medicare-drug-price-negotiation.

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.