Monthly Archives for August 2023

Health advocacy groups oppose groups against drug price negotiations

Published in RINewsToday on August 21, 2023

As supporters of President Biden’s Inflation Reduction Act (IRA) celebrate the one-year anniversary of the passage of this historic legislation, health advocacy groups gathered last week in Austin, Texas, Washington, D.C., Chicago and New York City to publicly oppose and call on the U.S. Chamber of Commerce, Pharmaceutical Research and Manufacturers of America (PhRMA) along with drugmakers to withdraw their lawsuits to block the IRA’s drug price negotiation provisions.  They instead called for the immediate lowering of the prices of brand-name pharmaceuticals.

At press time, Merck & Co., Bristol Myers Squibb Company, Janssen Pharmaceuticals, Astellas Pharma US, PhaRMA, and the U.S. Chamber of Commerce have filed lawsuits arguing that the price negotiation program is unconstitutional and violates the Constitution’s separation of powers clause by giving the U.S. Department of Health and Human Services (HHS) discretion over a maximum fair price for any given drug selected for negotiation.  These lawsuits charge that the Centers for Medicare & Medicaid Services’ (CMS) price controls would force drug manufacturers to pull back on developing new drugs, jeopardizing medical breakthroughs for individuals with life-threatening and chronic illnesses.

The filed legal suits come weeks before Sept. 1 when CMS is scheduled to publish a list of the first 10 drugs that will be subject to negotiations. By Oct. 1, the drug companies must declare whether they will participate in negotiations or face steep financial penalties for not negotiating. The lower negotiated prices will not take effect until 2026.

Public Citizen, a Washington, DC-based nonprofit consumer advocacy group along with other health care advocacy groups including Patients for Affordable Drugs Now, Protect Our Care, Families USA and Doctors for America and AARP and the AARP Foundation have filed amicus briefs supporting HHS’ position that the motion for a preliminary injunction requested by the Chamber and the other plaintiffs in that case should be denied.

At the Washington, D.C. press conference, Robert Weissman, president of Public Citizen delivered a petition signed by 150,000 individuals to the U.S. Chamber of Commerce demanding that all court suits be dropped. 

Public Citizen, Social Security Works, and more than 70 health and consumer organizations also sent letters to the prescription drug corporations, demanding those corporations drop their lawsuits and begin negotiating lower drug prices.  The letter cited how drug corporations routinely charge Medicare beneficiaries in the United States twice or more of what they charge patients in other large, wealthy countries – even in cases where U.S. taxpayers supported the drug’s development.

“It’s a disgrace that the U.S. Chamber of Commerce is fronting for Big Pharma [against the interests of the mom-and-pop businesses it purports to represent,” said Robert Weissman. “Patients, small businesses, large businesses, state and local governments, and the federal government all have a shared interest in curtailing Big Pharma price gouging, as the Inflation Reduction Act’s drug price negotiation provisions will do.”

“The lawsuits filed by the large pharmaceutical corporations to overturn Medicare drug price negotiation authority demonstrates that there is no bottom to big pharma’s greed, charges Max Richtman, President and CEO of the Washington, DC-based National Committee to Preserve Social Security and Medicare. “It isn’t enough that revenue to U.S. drug corporations was over $1 trillion in 2022.  It isn’t enough that big pharma benefits from the $54 billion spent in taxpayer dollars per year on pharmaceutical research. It isn’t enough that the 2017 Trump tax cut bill lowered average tax rates of the big pharmaceutical companies by more than 40 percent. It isn’t enough that pharma’s profit margin is 15 percent to 20 percent while the average profits of the nation’s largest 500 corporations ranged between 4 percent to 9 percent,” he says.   

“Americans have had enough of big pharma’s greed – and while I am sure the price gougers won’t stop putting profits before people – we urge the industry to drop this unconscionable lawsuit against the authority to negotiate prescription drug prices,” he adds.

“Big drug companies and their allies are fighting furiously to stop Medicare from negotiating drug prices so they can keep charging Americans the highest prices in the world. Allowing these distractions to derail implementation of the law would not be in the public’s interest, especially for older adults who have waited far too long for affordable drug prices. Medicare drug price negotiation represents a historic opportunity to access lifesaving drugs for millions of Americans at a time when they need them the most,” said William Alvarado Rivera, Sr. VP for Litigation at AARP Foundation.

“Pharmaceutical corporations have long shown that they care about nothing but profits. So, it is not surprising that they are attempting to use the courts to subvert the will of the people and block Medicare from using its bulk purchasing power to get better prices,” said Alex Lawson, executive director of Social Security Works. “The law is incredibly clear, as is the will of the American people: Medicare drug price negotiations are legal and incredibly popular. Everybody wins except the greedy CEOs who see their drug price extortion rackets shut down.”

Protests Call for the Immediate Dropping of Court Suits 

On Aug. 16, 2023, in Washington, D.C., the “Drop Your Suits, Drop Your Prices,” a press conference/rally was held outside the headquarters of the U.S. Chamber of Commerce in Washington, D.C., and in New York City outside of the offices of Jones Day, and outside the Federal Courthouse in Austin where some of the drug makers are launching their legal attacks on Medicare, and at the offices of Astellas in Chicago.

At the Washington, DC press conference, a digital billboard advertising on a parked box truck set the stage for the event. In big bold red and gold letters the message read: “The Chamber of Commerce and Big Pharma are suing to keep your drug prices high.  They must drop their lawsuits and lower drug prices.”

Public Citizen’s Weissman kicked off the noon time press conference, stating, the U.S. Chamber of Commerce claims to represent small businesses but these businesses are bearing the brunt of paying for the high price of drugs.  Because of this, 3 in 10 Americans are rationing their drugs, he says. 

Weissman asked why is the U. S Chamber of commerce opposing the interests of small and large businesses? He charges that the nation’s largest lobbying group for the nation’s businesses is “is shamefully fronting for Big Pharma and companies that have an interest in overturning this law” that requires Big Pharma to negotiate with Medicare on drug prices. “But we are here today to tell Big Pharma were not going to let you get away with it,” he says.

“We’re going to win. We’re going to win the in the courts. We’re going to win on the streets. This price negotiation is going to go forward. It’s the beginning not the end in getting big Pharma price gouging under control, making sure medicines are affordable for everyone who needs in this country,” predicts Weissman.

Like all the speakers, 22-year-old Jacqueline Garibay called on the U.S. Chamber of Commerce, PhaRMA, and the other pharmaceutical companies to immediately drop their lawsuits to lower drug prices.  She was diagnosed with Ankylosing Spondylitis, an autoimmune disorder that primarily affects her spine and has spread to most of her major joints. Without expensive biologic medications, Garibay’s spine could fuse and leave her unable to walk by the time she graduates from George Washington University.  

In the last four years since her diagnosis, doctors have put her on four biologic drugs, each one with a price tag ranging from $5,000 to $13,000 every month, trying to find one that will work for her.  There have been times when Garibay has had to forego refilling her prescriptions because of financial difficulties resulting from having to pay for her rent, groceries, and tuition at the same time. “It’s “absolutely terrifying,” she says, fearing that without taking these medications she will risk losing the ability to walk.  

“The new drug price reforms are projected to save patients like her tens of billions of dollars. “It will help me have a future I can afford, a future where I can pursue all my dreams without being financially undermined for the sake of my health condition,” she says.

Laura Marston, a 41-year-old diagnosed with Type 1 Diabetes over 27 years ago at age 14, has seen the price of her insulin soar from the price of a vial for $ 21 to over $300.  “No vial costs Eli Lilly less than $5 to make,” says the resident of Washington, D.C. 

Marston picked up her insulin prescription from the pharmacy a week ago. The price for a three-month supply of seven vials that will enable her to live was $ 2,267.99. “That’s immoral, that’s inhuman and that’s flat out wrong,” she said.

“My message to Eli Lilly, Novo Nordisk, Sanofi and the Chamber of Commerce is lower your insulin prices, or we will do it for you in the form of federal price caps legislation. The 7 million Americans who rely on insulin to level not-stop raising our voices until we no longer have to choose our money or our lives,” she says.

Arthur Blair, a patient advocate for Spaces in Action, described how a debilitating disease forced him to quick his job. What do you do when you don’t have money, not even enough to pay for high cost of drugs,” he asked. 

“Pharma has proven with this latest action [attempting to block the negotiation of drug prices] that they put unreasonable profits before the people. They don’t mind knowing that people are done because they are unable to obtain prescription drugs that would easily save their life and eliminate easier suffering,” charges Blair.

According to HHS, as of June 2021, about 48 million Medicare beneficiaries are currently enrolled in plans that provide the Medicare Part D drug benefit. Last year, Congress came together begin putting the brakes on spiraling drug costs by passing legislation that allows Medicare to negotiate for lower prices.  

Currently drug prices are higher in the U.S. than other countries because Medicare doesn’t negotiate prices with drug makers like other countries do. Because the practice of negotiating drug prices was banned in 2003 under the law that created the Medicare Part D prescription drug benefit, 77 percent of all Medicare beneficiaries pay more for prescription drugs than these nine countries — Austria, Australia, Belgium, Canada, Germany, Japan, Sweden, Switzerland and the United Kingdom (This was documented by a 2021 study of the Rand Corporation.) 

Although the “Drop Your Suits, Drop Your Prices” press conferences held around the nation drew small crowds, the importance of these gatherings is the message they sent to the nation, that is “It’s time to stop blocking a law that puts money into the pockets of seniors instead of the bank account of drug makers.”

To watch the https://www.youtube.com/watch?v=w_8WHFv7oL4

To read why the U.S. Chamber of Commerce is suing the U.S. Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services to challenge drug price negotiations, go to https://www.uschamber.com/lawsuits/why-were-suing-hhs-and-cms-to-challenge-illegal-price-controls.

To read an amicus brief submitted by Public Citizen, Patients for Affordable Drugs Now, Protect Our Care, Families U.S.A and Doctors for American, supporting HHS’s position that the motion for a  preliminary injunction requested by the Chamber and the other plaintiffs in that case should be denied, go to https://www.citizen.org/wp-content/uploads/35-1-Proposed-amicus-brief.pdf.

To read AARP and AARP Foundation’s full amicus brief, go to https://www.aarp.org/content/dam/aarp/aarp_foundation/2023/dayton-area-cha mber-of-commerce-v-becerra-brief.pdf.

Wake up call on spiraling brand-name drug prices 

Published in RINewsToday on August 14, 2023

By Herb Weiss

A new pharmaceutical drug price report that is both timely and overdue has been released by AARP’s Public Policy Institute, following on the heels of the Centers for Medicare & Medicaid Services (CMS) releasing in June, which revised guidance for the historic Medicare Drug Price Negotiation Program.  

This report details the list prices for the 25 brand-name drugs with the highest total Medicare Part D spending in 2021, noting that prices have increased by an average of 226%—or more than tripled—since they first entered the market. Those 25 drugs were responsible for $80.9 billion in total Medicare Part D spending in 2021, about 37% of the total spending, and were used by more than 10 million Part D enrollees.  It noted that, on average, nearly 60% of their current list price was due to price increases after the product entered the market.

The price of Enbrel, used to treat rheumatoid arthritis and psoriatic arthritis, has increased by 701% since coming to market in 1998, and the price of Januvia, used to treat diabetes, has increased by 275% since entering the market in 2006.

Overall, the lifetime price increases ranged from 20% to 739%, and all but one of the drugs’ lifetime price increases greatly exceeded the annual rate of inflation over the same period of time. 

Brand-name drug prices increase faster than inflation has – for decades

“Brand-name drug prices have increased dramatically faster than inflation for decades,” said Leigh Purvis, Prescription Drug Policy Principal, AARP Public Policy Institute, and author of the report.  “The median price of a new brand-name prescription drug is now approximately $200,000 per year, so even relatively small percentage price increases can translate into thousands of dollars and put life-saving medications out of reach of the patients who need them,” she said. 

“We know that there is lot of media attention on individual drug prices that take place year after year.  However, a lot less attention is paid to how those price increases are often building on top of a long line of price increases and how those relentless price increases add up over time,” says Purvis, during a press call to journalists scheduled on the day of the report’s release.

“These findings have huge implications for the people that AARP represents, many of whom need prescription drugs to help them stay well,” Purvis said. “People on Medicare prescription drug plans take on average of between 4 and 5 prescription drugs per month and their drugs are increasing covered using coinsurance where you pay a percentage of the drugs price instead of a flat co-pay.  In fact, across the country more and more people are facing cost sharing directly affected by drug price increases, whether it is by coinsurance or simply before they meet their deductible.  Millions of other people don’t have health coverage and are having to absorb the cost associated with growing drug prices on their own,” she said.

“Our analysis shows that drugs that have been on the market for twenty years or more have seen an average lifetime price increase of 592 percent.  In real terms this can be the difference of thousands of dollars for one person and enough to force the trade-offs that we often hear about, like choosing to put food on the table or being able to pay for gas,” notes Purvis.

“There is no justification for drug companies to engage in these type of price increases every year they are on the market, particularly increases that are so much higher than the price increases for other goods and services,”  adds Purvis. 

CMS releases revised guidance for negotiating with drug manufacturers 

Congress recently passed the Inflation Reduction Act (IFA), a federal law requiring drug companies to pay a penalty to Medicare if their drug’s price increases faster than the rate of inflation. The law will also give Medicare the ability to negotiate lower drug prices with drug companies for the first time. CMS is expected to announce the first 10 drugs selected for negotiation by September 1st, and the negotiated prices will become available in 2026.

“This historic law cracks down on the big drug companies and [will bring] real relief to millions of seniors who have been struggling with out-of-control prescription drug prices,” said Nancy LeaMond, AARP Executive Vice President and Chief Advocacy and Engagement Officer. “American families simply can’t afford to keep paying the highest prices in the world for the medications they need.”

Last March, CMS issued initial guidance to seek comments on its historic Medicare Drug Negotiation Program.  The agency received over 7,500 comments from consumer, patient groups, drug companies and pharmacies.  In June, CMS released its revised guidelines detailing the requirements and parameters of how the agency will oversee the new program.

“Issuing final guidance for the Medicare Drug Price Negotiation Program is an important “next step” in controlling spiraling high drug prices, says AARP’s LeaMond, noting that Medicare’s new buying power will get a better price for Medicare beneficiaries, saving the program billions of dollars and making prescription drugs more affordable.

Opposition, of course

At press time, the Pharmaceutical Research and Manufacturers of America (PhRMA), the leading industry lobby group for pharmaceutical companies, along with a group of pharmaceutical companies and trade groups, are suing the U.S. Health and Human Services to block the implementation of the Medicare Drug Price Negotiation Program established by the Inflation Reduction Act enacted by President Biden last August. The U.S. Chamber of Commerce has also filed a lawsuit in a U.S. District Court in Ohio to ask for an injunction to keep the negotiations from going forward. The trade group is challenging the constitutionality of the IFA’s drug price negotiation program.   

It’s a very high lift and big burden to meet the standard to stop the law from being implemented,” noted Kelly Bagby, AARP’s Vice President at AARP Foundation Litigation, before AARP’s press call ended.

“It is entirely appropriate and is necessary and the public interest is so enormous in balancing of the government’s interest verses the pharmaceutical companies and Chamber’s interest in this case,” says Bagby,” stressing that beneficiaries have to win this case. “It’s so obvious that pharmaceutical companies are not the victims they are painting themselves to be, she adds, affirming her belief that beneficiaries and Medicare have the strongest argument.  

Bagby noted, “AARP is working to protect the integrity of whole Medicare program for everybody and to allow for older people to not have to make horrible choices about do I pay my rent or do I get to take my life saving drugs.” 

Reports a Wake-Up Call

Although PhRMA,  pharmaceutical companies and trade groups along with the U.S. Chamber are strongly opposed to CMS’s new program to negotiation drug prices, polls show that people aged 50 and over, view the lowering of the price of costly prescription drugs to be a very important policy issue to them. Purvis hopes that the recently released AARP report will serve as a wake-up call for every American who is skeptical about the importance of lowering prescription drug prices. “Higher government spending driven by drug price increases will affect all Americans in the form of higher taxes, cuts to public programs, or both,” she predicts.  

For a copy of AARP’s Medicare Part D Drug Price report, go to https://www.aarp.org/pri/topics/health/prescription-drugs/prices-top-medicare-part-d-drugs-tripled-since-entering-market.html.

Rally round Martin O’Malley for Social Security Administration Commissioner

Published in RINewsToday on August 7, 2023

Just weeks ago, President Joe Biden nominated former Maryland Governor Martin O’Malley, Social Security Commissioner, to lead the Social Security Administration (SSA) in delivering benefits to 67 million Americans per month, totaling over 1 trillion dollars in benefits paid during the year. With the SSA Trust Fund running out of money in 2033 if changes are not made to financially shore up the program, O’Malley will be a key player in the fierce partisan battle on Capitol Hill to address the SSA’s solvency.   

In a tweet with over 91,000 views after his nomination, O’Malley said: “Humbled and honored to be chosen by @POTUS to lead @Social Security into the future. President Biden believes Social Security is a sacred promise.  I look forward to earning the Senate’s approval and serving with the hardworking patriots of the U.S. Social Security Administration.” 

After firing Andrew Saul in July 2021, a hold-over from President Trump’s administration who refused to resign, Biden had named Kilolo Kijakazi, who served as SSA’s deputy commissioner for retirement and disability policy, as Acting SSA Commissioner.  Over her tenure, Kijakazi oversaw the Baltimore, Maryland based independent agency’s efforts to maintain customer service amid the COVID-19 pandemic that forced the closure of SSA field offices throughout the nation. With the agency’s staffing levels at a 25-year low, along with using outdated technology, customer service plummeted because of long waits for phones in-person service.

Now O’Malley is headed to replaces Kijakazi as Social Security Commissioner. If confirmed by the Senate, he will serve a six-year appointed term.  O’Malley will be directly responsible for all programs administered by SSA; for state-administered programs directed by SSA; and for certain functions with respect to the black lung benefits program.

Lots of experience under O’Malley’s belt

O’Malley’s background as two-term Mayor of Baltimore and two-term Governor of Maryland, where he adopted data and performance-driven and customer service technologies to tackle complex challenges, will be helpful as he grapples with how to manage an understaffed and underfunded agency that has reduced SSA’s ability to determine in a timely fashion eligibility of persons seeking retirement, survivor, and disability benefits, and updating benefits promptly when circumstances change.  He has written extensively about how to govern for better results by measuring the outputs of government on a real-time basis.  

During his time as mayor, O’Malley’s policies helped achieve the greatest crime reduction of America’s largest cities. Prior to being elected Mayor, he served as a member of the Baltimore City Council, and Assistant States Attorney for the City of Baltimore before that.

According to the Georgetown University’s Institute for Politics and Public Service, O’Malley was called the best manager in government by Washington Monthly magazine.  “Under his leadership Maryland achieved nation-leading progress: Best public schools in America for an unprecedented five years in a row (Education Week); one of the top states in the nation for holding down the cost of college tuition (College Board); and #1 in innovation and entrepreneurship for three years running (U.S. Chamber of Commerce).” 

In 2016, O’Malley ran for the Democratic Party’s nomination for President of the United States. He dropped out of the race in the winter of 2016 after placing third in the Iowa caucus. He also served two terms as chair of the Democratic Governors Association and was appointed to the nation’s first-ever Council of Governors by President Obama in 2010.

O’Malley received his bachelor’s degree from Catholic University and his law degree from the University of Maryland. Since 2016, he has lectured on public administration at numerous universities and institutions, including the University of Maryland, Harvard University, Georgetown University, and Boston College School of Law.

He and his wife, Katie, a District Court judge, have two daughters, Grace and Tara, and two sons, William and Jack.

Calls for O’Malley’s Senate Confirmation

On July 26, Democratic lawmakers and social security advocates were quick to issue statements of support, strongly endorsing and celebrating O’Malley’s nomination to be SSA Commission.  Here is a listing of a few of these endorsements:

Oregon Senator, Chair of the Senate Finance Committee, Ron Wyden: “Social Security needs a confirmed commissioner in order to ensure Americans are receiving the best service possible for their earned Social Security benefits. Governor O’Malley is a proven leader with experience running a large organization that millions of families count on. I look forward to moving this nomination through the Finance Committee as soon as possible.” [Statement, 7/26/23 – https://www.finance.senate.gov/chairmans-news/wyden-statement-on-omalley-nomination-to-lead-social-security

Connecticut Congressman John Larson: “I applaud President Biden for nominating a champion for Social Security, Martin O’Malley, to lead the Social Security Administration and move it forward to better serve current and future beneficiaries. Governor O’Malley has long supported protecting and expanding Social Security. He knows just how important this program is to our seniors and that the modest payments they live on are simply not enough. I look forward to working alongside him as we work to ensure SSA has the resources it needs to serve our most vulnerable Americans for decades to come.” [Statement, 7/26/23 – https://larson.house.gov/media-center/press-releases/larson-statement-biden-nomination-martin-omalley-commissioner-social

Nancy Altman, President, Social Security Works: “Social Security Works and I, personally, applaud the nomination of Governor O’Malley, a longtime Social Security champion. We will do all we can to ensure his swift confirmation.  We look forward to working with him, once confirmed, to secure more funding for SSA as the president requested and higher benefits, with no cuts, as he, President Biden, and indeed the Democratic Party, through its 2020 platform, have called for.” [Statement, 7/26/23 – https://socialsecurityworks.org/2023/07/26/martin-omalley-will-fight-for-social-security/

Max Richtman, President and CEO, National Committee to Preserve Social Security and Medicare: “We commend President Biden for nominating former Maryland governor Martin O’Malley as Social Security Commissioner. It has been more than 20 years since the Senate has confirmed a permanent commissioner nominated by a Democratic president, and it is way past time for the Social Security Administration (SSA) to have one. As a confirmed commissioner, Martin O’Malley will be able to advocate effectively for SSA, which has been chronically underfunded and has struggled to provide adequate customer service. 

As a presidential candidate in 2016, Governor O’Malley championed the expansion of Social Security. He proposed boosting benefits and adopting a more generous (the CPI-E) for calculating COLAs — while adjusting the payroll wage cap so that the wealthy pay their fair share.  He insisted that ‘it is our responsibility to ensure that Americans who put in a lifetime of hard work are able to retire with the dignity they deserve.’ American workers’ payroll taxes largely fund the SSA.  They have every right to expect the agency that administers their benefits to be fully funded — with a permanent commissioner at the helm. The Senate should confirm Governor O’Malley in a timely manner when it returns from August recess.”

Richard Fiesta, Executive Director, Alliance for Retired Americans: “Members of the Alliance for Retired Americans are pleased that President Biden has nominated former Maryland Governor Martin O’Malley to be the next Social Security Administration (SSA) Commissioner. The SSA needs a strong Commissioner now more than ever. With 10,000 Americans turning 65 each day, the workload increases every day, and the budget has been woefully inadequate to meet the needs of seniors, people with disabilities and all-American families. Gov. O’Malley has a proven track record and the experience to navigate these challenges and ensure that Americans are able to get the benefits they have earned. American workers have earned their Social Security benefits, paying into the system with every paycheck. They deserve world class service from a fully staffed workforce equipped with the best tools and technology available. The Alliance for Retired Americans is confident that under Governor O’Malley’s leadership SSA will deliver. There is no time to waste. We urge the Senate to confirm Gov. O’Malley without delay.”

As SSA’s Commissioner, O’Malley will become the point person for Biden to push for an increase in the agency’s administrative expenses to improve computer technology, open field offices across the nation to improve the agency’s customer service by reducing backlog and wait-time on phone to its 67 million beneficiaries. (https://retiredamericans.org/retirees-praise-biden-nomination-of-martin-omalley-to-be-social-security-commissioner/)

Final thoughts…

Like Biden, O’Malley calls for defending the Social Security program against Republican attack, supporting the expansion of Social Security benefits, and raising SSA taxes on higher income beneficiaries. With Senate Republicans opposing these policies and a razor-thin Democratic majority in the upper chamber, expect O’Malley’s nomination to squeak by in being confirmed.  After the Senate returns from its month-long August recess, Senate Majority Leader Chuck Schumer (D-New York) must quickly move to schedule a vote on O’Malley’s nomination.  SSA now needs its top leader in place to begin working to fix SSA’s ongoing issues of financial solvency and customer service issues.

For more details about O’Malley, go to https://en.wikipedia.org/wiki/Martin_O%27Malley.