Tag Archives: Big Pharma

Biden Administration, Health Care, News & Photo Features

FACT SHEET: President Biden Takes New Steps to Lower Prescription Drug and Health Care Costs, Expand Access to Health Care, and Protect Consumers

Because of President Biden, Americans are now protected against receiving surprise medical bills for most emergency care and ambulance services as well as when consumers didn’t know they were getting care from an out-of-network provider – that has eliminated some 1 million “surprise” bills a month. © Karen Rubin/news-photos-features.com

The White House provided this fact sheet detailing actions President Biden has taken, and new actions he is taking to lower prescription drug and health care costs, expand access to health care and protect consumers, even as Republicans voted against giving Medicare the ability to negotiate drug prices and their presumed presidential nominee, Trump, is renewing calls to repeal the Affordable Care Act (Obamacare), which now has enabled a record 21 million to obtain health insurance, 9 million more than when Biden took office, and as he moves to negotiate for a $2000 cap on out-of-pocket prescription drug costs for all, not just Medicare recipients and expand the number of drug prices being negotiated from 10 to as many as 50 a year. –Karen Rubin, [email protected]

President Biden believes that health care is a right, not a privilege, and since day one, he has delivered health care to millions more Americans while also lowering health care costs. The President continues to build on, strengthen, and protect Medicare, Medicaid, and the Affordable Care Act, signing laws such as the American Rescue Plan Act and the Inflation Reduction Act to lower prescription drug costs and health insurance premiums. Thanks to the President’s efforts, more Americans have health insurance than under any other President, and are better protected against surprise medical bills and junk fees. Seniors are already seeing lower prescription drug prices with insulin capped at $35, free vaccines, and out-of-pocket costs for prescription drugs capped at $2,000 starting in 2025.  And the Administration is well on its way to lower the cost of range of drugs as Medicare negotiates over the prices of prescription drugs for the first time ever. The Biden-Harris Administration has also taken steps to make sure consumers aren’t scammed by junk insurance and have better access to mental health care.
 
However, the President is not just resting on these accomplishments.  He’s fighting to deliver even lower costs and better health care to Americans. That’s why the Biden-Harris Administration is acting to lower prescription drug costs, keep health insurance premiums low, expand access to health care, especially mental health care coverage, and continue to protect Americans from getting ripped off. 

Taking on Big Pharma to Deliver Lower Prescription Drug Costs for Seniors and Families

 After decades of opposition, President Biden enacted a law that finally takes on Big Pharma and gives Medicare the power to negotiate drug prices. President Biden’s Inflation Reduction Act will save millions of seniors money on some of the costliest prescription drugs on the market. Meanwhile, Big Pharma also executed over $135 billion in mergers and acquisitions in 2023 alone, while passing the cost to consumers. And eight of the 10 drugs selected for this year’s negotiation program raised their prices in 2024 – after all 10 drugs were already priced three to eight times higher in the United States than in other countries. President Biden knows how the Inflation Reduction Act is delivering for American families, and his Administration will continue the fight to lower health care costs for more Americans. 

  • Announcing that Manufacturers of 10 Drugs Remain at the Negotiating Table. Last month, for the first time in history, Medicare has made offers on the fair price for 10 of the most widely used and expensive drugs. Medicare is no longer taking whatever price for these drugs that the pharmaceutical companies demand. This week CMS announced that manufacturers for all 10 selected drugs are participating in drug price negotiation, with all manufacturers having submitted counteroffers and negotiations continuing.  Later this year, new, negotiated prices for the first 10 prescription drugs selected for the negotiation program will be announced.
     
  • Let Medicare Negotiate Drug Prices for at least 50 Drugs Every Year. Medicare should not be limited to negotiating just 20 drugs per year. Instead, the President is proposing that Medicare be able to negotiate prices for the major drugs that seniors rely on, like those used for treating heart disease, cancer, and diabetes. The Budget cuts federal spending by $200 billion increasing the number of drugs Medicare can select for negotiation and bringing more drugs into the negotiation process sooner, and other reforms.
     
  • Expand Cap on Out-of-Pocket Prescription Drug Costs. When the $2,000 out-of-pocket cap on prescription drugs applies in Medicare in 2025, nearly 19 million seniors and other beneficiaries are projected to save $400 per year on prescription drugs. The President is calling on Congress to expand the $2,000 out-of-pocket cap to all private insurance so that all Americans have the peace of mind that comes with knowing that they won’t have to choose between filling their prescription or putting food on the table.
     
  • Capping Medicare Cost-Sharing at $2 for Common Generic Drugs. Medicare will be launching a new model to limit Medicare Part D cost-sharing for certain generic drugs to $2. As Medicare prepares to launch the model, today HHS published a list of dozens of generic drugs for the model, including drugs like statins to treat high cholesterol, beta-blockers for high blood pressure, and platelet inhibitors to prevent blood clots. In his budget, the President is calling on Congress to limit Medicare cost-sharing to $2 for high-value generic drugs for all Medicare plans.
     
  • Access to Cell & Gene Therapies. In January, HHS announced that sickle cell disease will be the first focus of the Cell and Gene Therapy (CGT) Access Model. Under this model, CMS will negotiate with manufacturers on behalf of state Medicaid programs to increase affordable access to potentially lifesaving and life-changing treatment, and lower health care costs for some of the nation’s most vulnerable populations. Today, CMS is releasing the Request for Applications for drug manufacturers of cell and gene therapies to participate in the model.
     
  • Expand the IRA’s Requirement that Drug Companies Pay Rebates When They Increase Prices Faster than Inflation. Thanks to the IRA, drug manufacturers must now pay rebates to Medicare if their price increases for certain drugs exceed inflation. The President is calling on Congress to require those rebates for commercial drug sales, as well as sales to Medicare. That will save the federal government billions of dollars, further curb prescription drug price inflation, and reduce health insurance premiums for people with private health insurance coverage.

 
Putting High-Quality Health Care Within Reach
 
Today, more Americans have health insurance than under any President. The President’s efforts to lower health insurance premiums have led to record-breaking enrollment in the Affordable Care Act’s Marketplaces, with over 21 million people signing up for coverage – 9 million more than when the President took office. The Biden-Harris Administration isn’t stopping there and is building on this incredible success by:
 

  • Keeping Health Insurance Premiums Low. Thanks to the President’s American Rescue Plan and Inflation Reduction Act, millions of Americans are saving on average $800 a year on premiums. The Biden-Harris Administration is committed to keeping health insurance premiums low, giving families more breathing room and the peace of mind that health insurance brings. To do that, the President is calling on Congress to make the expanded premium tax credits that the Inflation Reduction Act extended permanent. Without Congressional action, millions of Americans will see their health insurance premiums spike by hundreds or thousands of dollars starting in the fall of 2025.
     
  • Closing the Medicaid Coverage Gap. The President continues to call on Congress to provide Medicaid-like coverage to people in the 10 states that have not adopted Medicaid expansion as well as keeping Medicaid expansion enrollees covered.
     
  • Keeping Kids Covered. Investing in our nation’s children is a top priority for the President. Research shows that when children have health insurance, they thrive: they’re healthier, they do better in school, and are more likely to succeed in adulthood. Keeping children covered is the right thing to do, which is why the President wants to make sure that children can never lose coverage due to red tape from birth until they turn age 6, and that families only have to submit Medicaid paperwork once every three years.
     
  • Closing Research Gaps in Women’s Health Research. In November 2023, the President and the First Lady launched the first-ever White House Initiative on Women’s Health Research to fundamentally change how our nation approaches and funds women’s health research. Women make up more than half the population but have been understudied and underrepresented in health research for far too long. As part of the initiative, the President during the State of the Union will call on Congress to make bold, transformational investments in women’s health research. 
     
  • Making Home Care More Available. Thanks to the American Rescue Plan, President Biden delivered $37 billion to all states to expand access to home care and improve the quality of caregiving jobs. The Biden-Harris Administration is taking steps to improve the quality of Medicaid home care services and to make sure home care workers get a bigger share of Medicaid payments for these critical services.  The President remains committed to further improving and expanding Medicaid home care services, and is calling on Congress to do their part to allow the hundreds of thousands of older adults and individuals with disabilities on Medicaid home care waiting list to remain in their homes and stay active in their communities while continuing to improve the quality of jobs for caregivers.
     
  • Ensuring Access to Mental Health Care. Ensuring robust access to mental health care has been a bipartisan priority for almost 15 years, including the enactment of mental health parity requirements which require health plans to cover mental health care benefits at the same levels as physical health care benefits. Yet today, too many Americans still struggle to find and afford the care they need. The President is committed to tackling the mental health crisis in this country, which means making health plans do their part and providing agencies with the needed support to make sure they’re doing so. The Biden-Harris Administration is working to finalize the mental health parity rule, which would close existing loopholes as well as ensure health plans evaluate access to mental health care in their networks, and make changes if it’s found to be inadequate. In addition, the President is calling on Congress to further increase access to mental health care by expanding coverage in Medicare and private insurance, applying the mental health parity requirements to Medicare beneficiaries, and extending Medicare incentive programs to address mental health provider shortages.

Cracking Down on Junk Insurance, Surprise Bills and Fees, and Confusing Health Care Pricing

 
Nothing infuriates the President more than seeing Americans get ripped off. That’s why the Biden-Harris Administration has prioritized implementing surprise billing protections, preventing 1 million Americans from receiving surprise medical bills every single month. The President has also taken steps to prevent Americans from being ripped off by junk insurance that preys on vulnerable citizens by closing loopholes to ensure consumers know what they’re buying and can get the health coverage that best meets their needs. But more can be done to protect consumers, which is why the President intends to:
 

  • Prevent More Surprise Medical Bills. Today, Americans are protected from receiving medical bills for most emergency care and air ambulance services as well as when consumers didn’t know they were getting care from an out-of-network provider despite doing their homework and going to an in-network facility for treatment.  The President wants to further protect consumers by applying surprise billing protections to ground ambulance providers. The last thing people should worry about during an emergency is an unexpected bill for their ambulance ride.
     
  • Crack Down on Junk Insurance. Last year, the Biden-Harris Administration proposed a monumental rule to help millions of Americans access high-quality, affordable health insurance and protect consumers from being discriminated against because of pre-existing conditions. Making sure Americans aren’t scammed into low-quality coverage, and charged more or denied life-saving care is a key priority for the Administration, which is why we are working to finalize proposed rules that limit the availability of junk insurance.

Honoring America’s Commitment to Seniors

The President has always believed that Medicare and Social Security are a promise—a rock-solid guarantee generations of Americans have counted on to be able to retire with dignity and security. The President will reject any efforts to cut the Medicare or Social Security benefits that seniors and people with disabilities have earned and paid into their entire working lives. The Budget honors that ironclad commitment—not only by rejecting benefit cuts, but by embracing reforms and investments that will protect and strengthen both programs. The President is committed to working with Congress to ensure Medicare and Social Security remain strong for their beneficiaries, now and in the future. 

  • Securing Medicare. In his budget, the President is calling on Congress to ensure that high-income individuals contribute their fair share to Medicare and directs revenue from the Net Investment Income Tax into the HI trust fund as was originally intended. In addition, the President has proposed to direct savings from further lowering drug costs into the Medicare trust fund.  If Congress were to heed the President’s call and enact these reforms, it would substantially extend solvency for the Medicare HI Trust Fund, guaranteeing seniors the benefits they have been promised.
     
  • Protects Seniors’ Health and Dignity. As President Biden pledged to do two years ago in the State of the Union, the Biden-Harris Administration is “set[ting] higher standards for nursing homes and make sure your loved ones get the care they deserve and that they expect.” The nursing home industry receives billions of dollars of taxpayer funding each year, but for too long, many facilities have not had the staff required to give residents safe, high-quality care. That is changing. HHS has proposed a new rule establishing a federal floor for nursing home staffing, so that owners cannot cut staffing to unsafe levels simply to turn a profit. This includes a proposal for every facility to have a Registered Nurse on site 24/7, in addition to minimum number of registered nurses and nurse aides to assist with care. Earlier this year, HHS also finalized a rule to increase transparency in nursing home ownership, making it easier for residents and their loved ones to hold facilities accountable. The final rule was just submitted to the Office of Management and Budget for review

Strong Record on Expanding and Strengthening Health Care Nationwide

 The President’s new actions are all in addition to an already impressive track record on fighting for the health care of Americans across the nation. Over the last three years, the President has:

  • Expanded health insurance through the ACA Marketplaces to an additional nine million Americans and helped over one million people in Missouri, North Carolina, Oklahoma, and South Dakota gain Medicaid coverage.
  • Extended postpartum Medicaid coverage to nearly 700,000 women across 44 states and the District of Columbia.
  • Kept children covered continuously in Medicaid and CHIP for a full year.
  • Made it easier for people to enroll in the ACA Marketplaces and Medicaid, including for older adults that are covered by both Medicaid and Medicare.
  • Made critical vaccines free for all Medicare beneficiaries as well as adults enrolled in Medicaid, with seniors on Medicare saving on average $70 in out-of-pockets for vaccines.
  • Lowered maximum out of pocket costs for Americans with employer and ACA coverage by an average of $400.
  • Capped out-of-pocket costs at $35 for a month’s supply of insulin for seniors and people with disabilities on Medicare.

Lowered coinsurance for seniors that took the 47 drugs covered by Medicare Part B that hiked prices faster than inflation in 2023, with some enrollees saving as much as $618 per dose.

Biden Administration, Health Care, News & Photo Features

FACT SHEET: Dozens of Pharma Companies Raised Prices Faster than Inflation, Triggering Medicare Rebates, While Republicans Work to Insure Giveaways to Big Pharma, Higher Costs for Seniors, Families

President Biden’s Inflation Reduction Act cracks down on Big Pharma price gouging, saving some seniors thousands of dollars per dose of medication. Meanwhile, Congressional Republicans push for giveaways to drug industry

President Biden’s Inflation Reduction Act cracks down on Big Pharma price gouging, saving some seniors thousands of dollars per dose of medication. Meanwhile, Congressional Republicans push for giveaways to drug industry © Karen Rubin/news-photos-features.com

President Biden visited the National Institutes of Health Clinical Center in Washington, D.C. to announce that dozens of pharmaceutical companies will be required to pay rebates to Medicare for outrageous price hikes on prescription drugs that over 750,000 seniors take per year. For the last quarter of 2023, 48 Medicare Part B drugs raised their prices faster than inflation, and some drug companies raised prices of certain medications faster than inflation for every quarter over the last year. President Biden’s Inflation Reduction Act cracks down on this exorbitant price gouging, requiring these companies to pay rebates back to Medicare, saving seniors who take these drugs between $1 and $2,786 per dose on their medication.

President Biden vowed to lower prescription drug costs for seniors and families – and he is delivering on that promise. His Inflation Reduction Act finally allows Medicare to directly negotiate lower prescription drug prices, capped the cost of insulin for Medicare beneficiaries at $35, made recommended adult vaccines free, requires drug companies to pay rebates if they raise prices faster than the rate of inflation, and locked in savings of $800 per year on health insurance for nearly 15 million Americans. While Republicans in Congress fight tooth and nail to repeal the Inflation Reduction Act and put money back in the pockets of Big Pharma, President Biden won’t back down from the fight to lower costs for hardworking Americans and make sure every family has access to affordable health care.

The Biden-Harris Administration announced:

  • The Department of Health and Human Services (HHS) announced a new list of 48 Medicare Part B drugs that raised their prices faster than inflation, and may be subject to inflation rebates in the first quarter of 2024 as a result of the Inflation Reduction Act. President Biden’s prescription drug law cracks down on price gouging from Big Pharma, requiring companies to pay back Medicare if they raise prices on seniors at a higher rate than inflation. Starting in January, some Medicare beneficiaries who take these 48 prescription drugs – including drugs used to treat cancer and fight infections – will have lower coinsurance than what they would have paid otherwise, and their out-of-pocket costs may decrease by $1 to as much as $2,786 per average dose.

Over the last four quarters, 64 drugs in total had prices that increased faster than inflation and may be subject to inflation rebates because of the Inflation Reduction Act. Some drugs, such as Signifor, used to treat an endocrine disorder, raised prices faster than inflation every quarter since the Inflation Reduction Act’s inflation rebate provision went into effect. Some Medicare beneficiaries who take Signifor could save $311 per monthly dose starting January because of the law.
 
The Administration is focused on making sure medications developed with taxpayer funds are available to Americans at reasonable prices. On average, Americans pay 2 to 3 times more than consumers in other developed countries for prescription drugs. Last week, the Administration announced a proposal to put drug companies on notice if products developed using federal funds are not made available to the public on reasonable terms, including based on price. The proposal would promote the federal government’s ability to license a patent — such as those used to create life-saving drugs — to a competitor with the goal of increasing competition and bringing costs down for families.
 
Building off last week’s announcement, today HHS announced that the Administration for Strategic Preparedness and Response (ASPR) is making fair pricing a standard part of contract negotiations for medical products developed or purchased as part of its commitment to obtain best value for the US taxpayer. In September 2023, ASPR finalized a Project NextGen contract agreement for a potentially life-saving COVID-19 treatment being developed by Regeneron stating if the product is commercialized, its list price in the United States will be equal to or less than its retail price in comparable global markets. Since then, ASPR has also included similar language in recent agreements with CastleVax, Codagenix and Gritstone Bio, developers of the first three vaccines selected for development within Project NextGen. These clauses will be in effect if and when a company’s candidate vaccine is selected to move into ASPR-supported Phase 2b trials to evaluate clinical safety and efficacy.These actions are the result of a successful and collaborative approach by ASPR and its industry partners and show HHS’s commitment to keep Americans from paying unfair prices for the care they need.

  • HHS is releasing new data on the ten drugs selected for Medicare Drug Price Negotiation. For Medicare enrollees who take these drugs, their out-of-pocket spending on the 10 drugs selected for negotiation represents, on average, over half of their total Part D out-of-pocket spending. The report shows that total Medicare spending on the 10 drugs more than doubled from 2018 to 2022 – a rate that was 3 times faster than all Part D drugs over the same period. The report also shows that 7 of the 10 drugs selected received direct at least one form of federal support towards their drug development or utilized a federal-funded invention for their development.

After decades and hundreds of billions of dollars spent by Big Pharma to block Medicare from directly negotiating lower prescription drug prices for people with Medicare, President Biden’s Inflation Reduction Act finally got it done. In total in 2022, Medicare Part D beneficiaries paid $3.4 billion in out of pocket costs for the 10 drugs selected for negotiation, and some paid over $6,000 per year for just one of the drugs on the list. Negotiated prices will go into effect for seniors in 2026.
Today’s announcements build off the actions the Administration has already taken to lower prescription drug costs for millions of seniors and families because of President Biden’s Inflation Reduction Act. In 2023 alone:

  • The Inflation Reduction Act saved nearly 15 million Americans an average of $800 in 2023 because of health insurance savings the law locked in.
    • The Inflation Reduction Act capped the cost of insulin at $35 per covered insulin product for Medicare beneficiaries, saving an estimated 1.5 million seniors on Medicare $500 on average in 2023 on insulin costs. 
       
    • The Inflation Reduction Act made recommended vaccines – like the shingles vaccine – free for the 50.5 million seniors with Medicare Part D, and made recommended, approved adult vaccines free for all adults in the Children’s Health Insurance Program, and nearly all full-benefit adults enrolled in traditional Medicaid. Seniors on Medicare who received a Part D vaccine saved an average of $70 on vaccines in 2023.
       
    • The Inflation Reduction Act saved many seniors on Medicare as much as $618 per average dose on 47 prescription drugs in 2023 because of the law’s provision requiring drug companies to pay rebates on certain drugs if they raise prices for those drugs faster than the rate of inflation. Starting in 2024, some seniors who take 48 prescription drugs could see savings of as much as $2,786 per average dose because those 48 drugs raised their prices faster than inflation in the last quarter of 2023.

In the coming months and years, the Inflation Reduction Act will continue to deliver cost-savings to millions of Americans, including:

  • In 2024, Part D enrollees will no longer pay 5% co-insurance when they reach the catastrophic phase of their benefit – meaning that some beneficiaries’ prescription drug costs will be capped at about $3,500 next year.
    • When the $2,000 out-of-pocket cap on prescription drugs applies in 2025, nearly 19 million seniors and other beneficiaries are projected to save $400 per year on prescription drugs. 1.9 million enrollees with the highest drug costs will save an average of $2,500 per year because of this provision of the Inflation Reduction Act.
       

Millions of seniors could save money when negotiated prices of the first group of drugs selected for the Inflation Reduction Act’s Medicare Price Negotiation program are scheduled to go into effect in 2026. In 2022, seniors spent $3.4 billion in out-of-pocket costs on the first ten drugs selected for negotiation – used to treat common conditions like diabetes, Crohn’s disease, arthritis, blood clots and more. A report released last week shows that had the Medicare price negotiation program been in effect in 2021, Part D out of pocket costs would have declined 23% for people taking the ten costliest drugs at the time.

The Congressional Republican Agenda on Prescription Drugs: Giveaways to Big Pharma and Higher Costs for Seniors and Families


While President Biden has taken historic action to reduce prescription drug costs for seniors and for working-age people who get health insurance through their jobs, Congressional Republicans are actively fighting to roll back the reforms the President signed into law and to keep Big Pharma’s taxes low.
 
Congressional Republicans’ agenda for Big Pharma giveaways includes:
 
Repealing prescription drug inflation rebates. The Inflation Reduction Act (IRA) cuts costs for Medicare and seniors by requiring pharmaceutical companies to pay a rebate to Medicare if they increase prices faster than inflation. Dozens of Republicans have signed onto legislation that would revoke the rebate requirement.
 
By 2031, repealing this provision would:

  • Cost seniors $5 billion per year.
  • Increase federal deficits by $7 billion per year.
  • Give away over $10 billion per year to pharmaceutical companies.

Taking away Medicare’s ability to negotiate prescription drug prices. The IRA finally gave Medicare the authority to directly negotiate with drug companies on the high prices they charge for prescription drugs. Republican Chairs and Ranking Members of the committees with jurisdiction over Medicare have publicly committed to repealing this authority, which would allow Big Pharma to go back to charging seniors exorbitant prices for life-saving drugs.
 
By 2031, repealing this provision would:

  • Cost seniors $7 billion per year.
  • Increase federal deficits by $14 billion per year.
  • Give away over $20 billion to pharmaceutical companies per year.

Opposing caps on insulin prices. Monthly insulin costs for Medicare beneficiaries are now capped at $35—providing certainty and critical cost savings for seniors who in some cases were paying as much as $400 for a month’s supply of insulin. The Republican Study Committee budget, as well as the House Budget Committee-passed budget plan, propose to repeal this and other IRA drug price reforms.  
 
Repealing this provision would mean the 1.5 million Medicare beneficiaries who use insulin could see their annual costs rise by an average of $500.
 
Protecting Big Pharma’s ability to avoid paying taxes. President Biden negotiated a historic agreement with over 130 countries that would enable the U.S. and its partners to ensure Big Pharma and other multinationals pay at least a minimum tax rate and has proposed that the U.S. implement that agreement with a 21% minimum tax rate on multinationals. Congressional Republicans are not only blocking the U.S. from implementing the global minimum tax agreement and vowing to never raise taxes on Big Pharma and other multinationals by implementing it, they also traveled to Europe this summer to try to persuade other countries to withdraw from the global agreement and keep taxes low for Big Pharma and other multinationals.
 
Blocking implementation of the President’s international tax reform proposals means:

  • Protecting a system in which Big Pharma can lower its taxes to under 12% by shifting profits offshore.

The U.S. would lose out on hundreds of billions in savings from adopting the President’s proposals to implement the international agreement. Based on a PhRMA-funded analysis, nearly $100 billion of the savings – or almost one-fifth of the total revenue – from implementing the President’s 21% minimum tax proposal would come from cracking down on pharmaceutical industry tax avoidance

Biden Administration, Health Care

FACT SHEET: Biden-Harris Administration Announces New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition

While the dictator wannabe Donald Trump promises to tear up the Constitution, weaponize the judiciary, persecute political opponents, imprison the media and repeal the Affordable Care Act (Obamacare) – and monopolizing headlines doing it as he propagandizes over his 91 indictments – President Biden is working feverishly and accomplishing landmark programs  to improve lives of Americans. Here is a fact sheet on the Biden-Harris Administration’s new actions to lower healthcare and prescription drug costs by promoting competition. – Karen Rubin/news-photos-features.com

Among the actions the Biden-Harris Administration is taking to lower healthcare and drug costs, are new regulations improving transparency of hospital charges © Karen Rubin/news-photos-features.com

President Biden believes that health care should be a right, not a privilege. For too long, corporate special interests and trickle-down economics have allowed Big Pharma to make record profits, while millions of Americans struggle to afford health care and prescription drugs to treat common and chronic conditions. As part of the President’s Bidenomics agenda, the Biden-Harris Administration is cracking down on price gouging and taking on special interests to lower costs for consumers and ensure every American has access to high-quality, affordable health care.
 
The Biden-Harris Administration is announcing new actions to promote competition in health care and support lowering prescription drug costs for American families, including the release of a proposed framework for agencies on the exercise of march-in rights on taxpayer-funded drugs and other inventions, which specifies that price can be a factor in considering whether a drug is accessible to the public. The Administration believes taxpayer-funded medications should be reasonably available and affordable. These actions build on the steps the Administration has already taken to lower health care costs, including capping the cost of insulin at $35 per product per month for seniors, finally allowing Medicare to negotiate lower prescription drug prices, requiring drug companies to pay rebates to Medicare if they raise prices faster than inflation, and locking in $800 per year in health insurance savings for 15 million Americans under President Biden’s Inflation Reduction Act.

Lowering Prescription Drug Costs

Currently the 25 largest pharmaceutical companies control around 70% of industry revenues. Other parts of the health care industry also face limited competition. Over 75% of Americans live in highly concentrated hospital markets, and just three or fewer issuers of individual health insurance control 80% of the market in 44 states.  In addition, five insurers control over 70% of the Medicare Advantage market.  This consolidation contributes to higher costs for taxpayers, lower wages for health care workers, and worse quality of care for patients.
 
New research released by the Department of Health and Human Services (HHS) finds that a lack of competition in drug markets is highly correlated with higher prices. Among the highest priced drugs (i.e., those in the top 10% of price per prescription), 89% of small molecule drugs and 100% of biological products had only one manufacturer. Meanwhile, nearly three in ten individuals struggle to pay for the drugs they need.

Today, the Biden-Harris Administration announced a new action to support lowering prescription drug costs and increase Americans’ access to life-saving medications:

  • Promoting equitable access to lower-priced taxpayer-funded drugs. Taxpayers have spent hundreds of billions of dollars on research catalyzing the discovery and development of new prescription drugs. The Biden-Harris Administration believes taxpayer-funded drugs and other taxpayer-funded inventions should be available and affordable to the public. When an invention is made using taxpayer funds, under certain circumstances march-in authority under the Bayh-Dole Act enables the federal government to license the invention to another party. The prior Administration proposed a rule preventing the government from exercising this authority on the basis of high price alone. The Biden-Harris Administration decided not to finalize that proposal earlier this year, consistent with President Biden’s Executive Order on Promoting Competition in the American Economy. Today, the Department of Commerce (DOC) and HHS released a proposed framework for agencies on the exercise of march-in rights that specifies for the first time that price can be a factor in determining that a drug or other taxpayer-funded invention is not accessible to the public. DOC and HHS invite public input on how this framework can promote access to taxpayer-funded inventions, including treatments for patients, while promoting innovation.

Scrutinizing Anticompetitive Acquisitions and Anticompetitive Practices

Consolidation in health care markets has accelerated in recent decades, too often leading to higher costs, worse quality, and less access to care—particularly in rural areas. For example, a review of hospital merger studies finds that mergers in concentrated markets led to price increases often exceeding 20%. Consolidation has also led to a rapid decline in independent physician practices, with research finding that patients of hospital-owned practices pay nearly $300 more for similar care than at independent physician practices. At the same time, private-equity ownership in the health care industry has ballooned, with approximately $750 billion in deals between 2010 and 2020—in sectors including, but not limited to, physician practices, nursing homes, hospices, home care, autism treatment, and travel nursing. Too often, aggressive profiteering by private equity-owned practices can lead  to higher patient costs and lower quality care.

Today, the Biden-Harris Administration announced new efforts to stop anticompetitive mergers and anticompetitive practices by dominant corporations in health care markets:

  • Launching a cross-government public inquiry into corporate greed in health care. The Biden-Harris Administration believes that the health care system should serve patients, not corporate profiteers. The Administration is concerned that our health care system is increasingly being financialized, with corporate owners like private-equity firms and others maximizing their profits at the expense of patients’ health and safety, while increasing costs for patients and taxpayers alike. The Department of Justice (DOJ), the Federal Trade Commission (FTC), and HHS will issue a joint Request for Information to seek input about how private equity and other corporations’ increasing power and control of our health care is affecting Americans. The agencies will use this joint Request for Information to identify areas for future regulation and enforcement prioritization, and they will continue to work together on case referrals, reciprocal training programs, data-sharing, and further development of additional health care competition policy initiatives. As part of this effort, HHS will appoint a Chief Competition Officer and DOJ’s Antitrust Division and FTC will name Counsels for Health Care to lead these efforts.
    • Identifying anticompetitive “roll ups” that currently evade antitrust review. Businesses, including private equity firms, health insurers, and health systems sometimes use a “roll up” strategy, in which a series of relatively small acquisitions can lead to the consolidation of a market and contribute to worse patient outcomes while increasing taxpayer costs. These serial acquisitions may violate the antitrust laws. However, each individual acquisition may fall below the size thresholds for reporting the prospective deal to the antitrust enforcement agencies before consummating the acquisition—making it more challenging for the enforcement agencies to identify anticompetitive transactions at the outset. Today, HHS, DOJ, and FTC announced that they will, to the maximum extent possible, engage in data sharing to help the antitrust enforcers identify potentially anticompetitive transactions that might otherwise evade ready review by antitrust enforcers.  
       
    • Increasing ownership transparency. HHS, through the Centers for Medicare & Medicaid Services (CMS), has taken unprecedented action to shed light on ownership trends in health care. The Biden-Harris Administration is the first to make ownership data on hospitals, nursing homes, hospice providers, and home health agencies publicly available, and today, CMS is releasing, for the first time, ownership data on Federal Qualified Health Centers and Rural Health Clinics on data.cms.gov. Making ownership information transparent allows for identification of common owners with histories of poor performance, analysis of trends on how market consolidation impacts consumers, and evaluation of the relationships between ownership and changes in health care costs and outcomes.
       
    • Increasing Medicare Advantage transparency. Currently, about 50% of Medicare enrollment is in Medicare Advantage and the government is expected to spend over $7 trillion on Medicare Advantage over the next decade. The Biden-Harris Administration is committed to ensuring Medicare Advantage insurance plans best meet the needs of people with Medicare, there is timely access to care, and the market has healthy competition. To support this work, CMS must have comprehensive and high-quality Medicare Advantage programmatic data, including understanding the effects of market shifts on consumers and care outcomes. CMS has taken steps to improve Medicare Advantage data transparency and today, it is announcing a new phase of this work, which will start with soliciting information from the public early next year to strengthen CMS’ data capabilities and Medicare Advantage transparency efforts.

Building on Past Actions to Increase Health Care Competition and Lower Prescription Drug Costs

Today’s announcements build on steps the Administration has already taken to lower health care costs, increase competition, and improve the quality and availability of care across the health care industry. These include:

  • Negotiating and lowering drug prices. Thanks to President Biden’s Inflation Reduction Act, the Administration has announced 10 prescription drugs for which Medicare will negotiate prices directly with participating manufacturers. These drugs cost people with Medicare $3.4 billion out of pocket in 2022. This builds on other progress to lower prescription drug costs. Individuals with Medicare can now receive certain vaccines for free under the President’s lower cost prescription drug law, which previously would have cost an average of $70 in out-of-pocket costs. The Inflation Reduction Act also capped the cost of insulin at $35 per product per month for almost four million seniors and others on Medicare with diabetes, which can lead to hundreds of dollars in savings for a month’s supply.
    • Stopping Big Pharma tactics that raise prices for working families. In September, the FTC issued an enforcement policy statement explaining that Big Pharma companies may face legal action if they delay entry of generic competitors with improper patent listings in the Food and Drug Administration’s (FDA’s) publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.” When a brand pharmaceutical company improperly lists a patent in the Orange Book, it may lead to a 30-month statutory stay that blocks the approval of competing drug products, including lower-cost generic alternatives. Such improper listings may delay competition and raise prices for life-saving products like asthma inhalers. FTC and FDA are working to address such improper listings, with FTC announcing last month that it is using FDA’s regulatory Orange Book patent listing dispute process to challenge more than 100 patents listed for brand-name asthma inhalers, epinephrine autoinjectors, and other drug products.
       
    • Cracking down on anticompetitive and anti-consumer practices in Medicare Advantage. Medicare Advantage—which serves over 30 million American seniors and people with disabilities—is increasingly dominated by just a few large national plans. Last month, HHS announced new steps to stop predatory marketing and steering of patients to Medicare Advantage plans that may not best meet their needs. HHS, through CMS, proposed a rule that would, if finalized as proposed, stop large insurance plans from offering brokers and agents lavish compensation—such as cash bonuses, volume bonuses, and perks—and working with marketing middlemen who are more likely to contract with larger insurers, leading to steerage of patients to plans based on compensation to the broker or agent, rather than based on the patients’ best interests. The agency also proposed new steps to ensure seniors and people with disabilities can actually access supplemental benefits like hearing and dental coverage that these large plans market and help drive up Medicare costs—so that they aren’t merely marketing ploys. In addition, CMS will continue to implement updates to Medicare Advantage payment that improve payment accuracy, address gaming, and recover overpayments. Addressing overpayment in Medicare Advantage will help to make the market more competitive between Medicare Advantage plans and create a more level playing field between Medicare Advantage and Traditional Medicare.
       
    • Making hearing aids available over the counter. To lower the price of hearing aids and expand access, President Biden’s Executive Order on Promoting Competition in the American Economy called on the FDA to act promptly to make hearing aids available over the counter, without a prescription. That is now a reality. Under a final rule issued by the FDA, hearing aids are now on store shelves across the country—for thousands of dollars less than before. The rule is also spurring competition among providers, leading to new features and models. 
       
    • Cracking down on nursing homes that endanger resident safety. In recent years, there has been a disturbing trend towards private equity firms and other large corporate owners purchasing nursing homes and slashing levels of staff to maximize profits. The Biden-Harris Administration has taken numerous steps to crack down on nursing homes that put the well-being of their residents at risk, including proposing a rule that, if finalized as proposed, would establish a federal floor for safe staffing levels. In addition, last month CMS finalized a rule that will provide the public with more information about who owns a nursing home—including whether facilities are owned by a private equity company or a real estate investment trust—so that families can make more informed decisions about where to seek nursing home care for their loved ones.
       
    • Reforming the organ transplant system. President Biden recently signed a bipartisan law, the Securing the U.S. Organ Procurement and Transplantation Network Act, to break up the monopoly that has controlled the organ transplant system for its entire nearly four decade history. HHS will harness competition with the intent to make multiple awards to different entities to benefit from best-in-class vendors and provide a more efficient system that strengthens oversight and improves patient safety.
       
    • Addressing anticompetitive misuse of the patent system. The FDA and U.S. Patent and Trademark Office are working together on a robust set of initiatives aimed at protecting and promoting U.S. innovation while advancing marketplace competition that can lower drug prices and expand access.
       
    • Banning non-compete agreements that trap health care workers and others. The FTC proposed a rule to ban employers from using non-compete clauses. The estimated 18% of workers covered by non-compete clauses include many across the health care industry such as doctors and nurses, who will have more employment opportunities if the rule is finalized.
       
    • Promoting competition in eyeglasses. Bundling eye exams with the purchase of eyeglasses reduces competition in the market for eyeglasses—raising prices and reducing options for consumers. The FTC proposed an update to its Eyeglass Rule to make sure that eye doctors give patients their prescriptions immediately after their eye exam—facilitating consumers’ ability to choose where to get their eyeglass prescriptions filled.
       
    • Developing new payment models for doctors including supporting independent doctors. Succeeding in value-based care can be challenging for small, independent physician practices. Beginning July 1, 2024, the CMS Innovation Center’s Making Care Primary Model will provide a pathway for primary care clinicians to gradually adopt prospective, population-based payments that support the delivery of advanced primary care. 
       

Improving transparency of hospital charges. CMS hospital price transparency regulations lay the foundation for a patient-driven health care system by making hospitals’ standard charges’ data available to the public.  Last month, CMS strengthened these regulations to require hospitals to make charges available in a more standardized manner to streamline enforcement capabilities. This will help the public learn how much an insurance company pays for a particular hospital service, for third parties to develop consumer-friendly materials, for hospitals to comply, and for CMS to enforce the regulations.

Biden Administration, Health Care, News & Photo Features

Biden-Harris Administration Proposes Steps to Protect People with Medicare Advantage and Prescription Drug Coverage

The Biden-Harris Administration is proposing important steps to strengthen Medicare Advantage and the Medicare Prescription Drug Benefit Program (Part D). As part of his Bidenomics agenda, President Biden has worked to increase competition in the health care industry and other sectors, lower costs for families, and make sure every American has access to affordable, high-quality health care. © Karen Rubin/news-photos-features.com

The Biden-Harris Administration is proposing important steps to strengthen Medicare Advantage and the Medicare Prescription Drug Benefit Program (Part D). As part of his Bidenomics agenda, President Biden has worked to increase competition in the health care industry and other sectors, lower costs for families, and make sure every American has access to affordable, high-quality health care.

The Centers for Medicare & Medicaid Services’ (CMS’) proposed rule will help people with Medicare select and enroll in coverage options that best meet their health care needs by preventing plans from engaging in anti-competitive steering of prospective enrollees based on excessive compensation to agents and brokers, rather than the enrollee’s best interests. The proposed guardrails protect people with Medicare and promote a competitive marketplace in Medicare Advantage, consistent with the goals of President Biden’s historic Executive Order on Promoting Competition in the American Economy.

The proposed rule will also improve access to behavioral health care by adding a new facility type that includes several behavioral health provider types to Medicare Advantage network adequacy requirements. CMS is also proposing policies to increase the utilization and appropriateness of supplemental benefits to ensure taxpayer dollars actually provide meaningful benefits to enrollees. Additionally, the proposed rule would improve transparency on the effects of prior authorization on underserved communities and proposes more flexibility for Part D plans to more quickly substitute lower cost biosimilar biological products for their reference products.

“The Biden-Harris Administration remains committed to making health care more affordable and accessible for all Americans. By ensuring Medicare recipients have the information they need to make critical decisions about their health care coverage, we are doing just that,” said U.S. Department of Health and Human Services Secretary Xavier Becerra. “Promoting competition in the marketplace helps to lower costs and protect access to care while making the whole process more transparent and accountable.”

“CMS continues to improve the Medicare Advantage and Part D prescription drug programs and maintain high-quality health care coverage choices for all Medicare enrollees,” said CMS Administrator Chiquita Brooks-LaSure. “People with Medicare deserve to have accurate and unbiased information when they make important decisions about their health coverage. Today’s proposals further our efforts to curb predatory marketing and inappropriate steering that distorts healthy competition among plans.”

CMS has previously taken unprecedented steps to address predatory marketing of Medicare Advantage plans, such as banning misleading TV ads. Many people on Medicare rely on agents and brokers to help navigate Medicare choices. CMS is concerned that some Medicare Advantage plans are compensating agents and brokers in a way that may circumvent existing payment rules, inappropriately steer individuals to enroll in plans that do not best meet their health care needs, and lead to further consolidation in the Medicare Advantage market. To further protect people with Medicare through stronger marketing policies and to promote a competitive marketplace in Medicare Advantage, CMS is proposing added guardrails to plan compensation for agents and brokers, including standardization. These proposals are consistent with the statutory requirement that CMS develop guidelines to ensure that the use of compensation creates incentives for agents and brokers to enroll individuals in the Medicare Advantage plan that is intended to best meet their health care needs.

CMS also proposes to strengthen and improve access to behavioral health care by adding a new facility type, which includes marriage and family therapists, mental health counselors, addiction medicine clinicians, opioid treatment providers, and others, to CMS’ Medicare Advantage network adequacy requirements. This proposed addition builds on changes finalized last year to strengthen these requirements and would ensure people with Medicare Advantage can access vital mental health and substance use disorder treatment.

“The people we serve are at the center of the Medicare program, and we work each day to make sure the program works for them. Agents and brokers play an important role in guiding people with Medicare to the option that is tuned in to their medical needs. Our proposals on how plans compensate agents and brokers seek to support a competitive marketplace that best serves people with Medicare,” said Dr. Meena Seshamani, CMS Deputy Administrator and Director of the Center for Medicare.

Currently, 99% of Medicare Advantage plans offer at least one supplemental benefit. Over time, the benefits offered have become broader in scope and variety, with more rebate dollars directed toward these benefits. CMS is committed to ensuring these offerings are effectively reaching enrollees and actually meeting their needs, and not just used for attracting enrollees. In today’s rule, CMS proposes requiring Medicare Advantage plans to send a personalized notification to their enrollees mid-year of the unused supplemental benefits available to them to encourage higher utilization. Furthermore, CMS is proposing additional requirements designed to help ensure that benefits offered as special supplemental benefits for the chronically ill (SSBCI) are backed by evidence. CMS is also proposing new marketing and transparency guardrails around these benefits. These proposals will help ensure a robust and competitive Medicare Advantage marketplace made up of plan options with meaningful benefits.

Additionally, CMS is concerned that certain prior authorization policies may disproportionately inhibit access to needed care for underserved enrollees. To provide additional safeguards, CMS is proposing to require that Medicare Advantage plans include an expert in health equity on their utilization management committees and that the committees conduct an annual health equity analysis of the plans’ prior authorization policies and procedures. This analysis would examine the impact of prior authorization on enrollees with one or more of the following social risk factors—eligibility for Part D low-income subsidies, dual eligibility for Medicare and Medicaid, or having a disability—compared to enrollees without these risk factors. These analyses would have to be posted publicly to improve transparency into the effects of prior authorization on underserved populations. To further promote health equity, CMS is also proposing to streamline enrollment options for individuals with both Medicare and Medicaid, providing more opportunities for integrated care.

To support competition in the prescription drug marketplace, CMS is also proposing to provide more flexibility to substitute biosimilar biological products other than interchangeable biological products for their reference products to give people with Medicare more timely access to lower-cost biosimilar drugs. This proposal would permit Part D plans to treat such substitutions as maintenance changes so that the substitutions apply to all enrollees, not only those who begin the therapy after the effective date of the change, following a 30-day notice.

There will be a 60-day comment period for the notice of proposed rulemaking, and comments must be submitted at one of the addresses provided in the Federal Register no later than January 5, 2024. The proposed rule can be accessed at the Federal Register at https://www.federalregister.gov/public-inspection/current.

View a fact sheet on the proposed rule at cms.gov/newsroom.

View the CMS Blog Important New Changes to Improve Access to Behavioral Health in Medicare at https://www.cms.gov/blog.

Biden Administration, Health Care, News & Photo Features

Biden Administration Takes Historic Step to Lower Cost of Prescription Drugs for Medicare, Medicaid

For the first time, thanks to President Biden’s Inflation Reduction Act – the historic law lowering health care costs – Medicare is able to negotiate the prices of prescription drugs. HHS released the list of the first 10 drugs that it will negotiate prices for.When implemented, prices on negotiated drugs will decrease for up to 9 million seniors. These seniors currently pay up to $6,497 in out-of-pocket costs per year for these prescriptions. In addition, the nonpartisan Congressional Budget Office reports that this will save taxpayers $160 billion by reducing how much Medicare pays for drugs through negotiation and inflation rebates. © Karen Rubin/news-photos-features.com

In the immortal words of President Biden as VP when President Obama signed the Affordable Care Act (Obamacare) into law, this is a big f—kg deal.

For the first time, thanks to President Biden’s Inflation Reduction Act – the historic law lowering health care costs – Medicare is able to negotiate the prices of prescription drugs.

Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced the first 10 drugs covered under Medicare Part D selected for negotiation. The negotiations with participating drug companies will occur in 2023 and 2024, and any negotiated prices will become effective beginning in 2026. Medicare enrollees 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. 

“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. But thanks to the landmark Inflation Reduction Act, we are closer to reaching President Biden’s goal of increasing availability and lowering prescription drug costs for all Americans,” said HHS Secretary Xavier Becerra. “Although drug companies are attempting to block Medicare from being able to negotiate for better drug prices, we will not be deterred. The Biden-Harris Administration will continue working to ensure that Americans with Medicare have access to innovative, life-saving treatments at lower costs.”

The Biden-Harris Administration has made lowering prescription drug costs and improving access to innovative therapies a key priority. Alongside other provisions in the new law that increase the affordability of health care and prescription drugs, allowing Medicare to negotiate prescription drug prices will strengthen the program’s ability to serve people with Medicare now and for generations to come. The negotiation process will consider the selected drug’s clinical benefit, the extent to which it fulfills an unmet medical need, and its impact on people who rely on Medicare, among other considerations, such as costs associated with research and development as well as production and distribution for selected drugs. As a result of negotiations, people with Medicare will have access to innovative, life-saving treatments at lower costs to Medicare.

The selected drug list for the first round of negotiation is:

  • Eliquis
    • Jardiance
    • Xarelto
    • Januvia
    • Farxiga
    • Entresto
    • Enbrel
    • Imbruvica
    • Stelara
    • Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill

These selected 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. 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 Inflation Reduction Act.

“We’ve reached this milestone because of the Inflation Reduction Act– one of the most significant laws ever enacted, and one that passed with the leadership of Democrats in Congress,” President Biden stated. “We took on Big Pharma and special interests, overcoming opposition from every Republican in Congress, and the American people won.”

When implemented, prices on negotiated drugs will decrease for up to 9 million seniors. These seniors currently pay up to $6,497 in out-of-pocket costs per year for these prescriptions. In addition, the nonpartisan Congressional Budget Office reports that this will save taxpayers $160 billion by reducing how much Medicare pays for drugs through negotiation and inflation rebates.

“This plan is a key part of Bidenomics, my economic vision for growing the economy from the middle out and the bottom up – not the top down. And it’s working.,” Biden stated. “That’s why Big Pharma has already filed eight lawsuits against my Administration, and spent nearly $400 million last year to try to stop our progress. Let me be clear: I am not backing down. There is no reason why Americans should be forced to pay more than any developed nation for life-saving prescriptions just to pad Big Pharma’s pockets. For many Americans, the cost of one drug is the difference between life and death, dignity and dependence, hope and fear. That is why we will continue the fight to lower healthcare costs – and we will not stop until we finish the job.”

HHS Announces First Set of Drugs Selected for Medicare Price Negotiation

For the first time ever, HHS announced ten drugs selected for Medicare drug price negotiation:
 

Drug NameCommonly Treated ConditionsTotal Part D Gross Covered Prescription Drug Costs from June 2022-May 2023Number of Medicare Part D Enrollees Who Used the Drug from June 2022-May 2023Average Part D Covered Prescription Drug Costs Per Enrollee
EliquisPrevention and treatment of blood clots$16,482,621,0003,706,000$4,448
JardianceDiabetes; Heart failure$7,057,707,0001,573,000$4,487
XareltoPrevention and treatment of blood clots; Reduction of risk for patients with coronary or peripheral artery disease$6,031,393,0001,337,000$4,511
JanuviaDiabetes$4,087,081,000869,000$4,703
FarxigaDiabetes; Heart failure; Chronic kidney disease$3,268,329,000799,000$4,091
EntrestoHeart failure$2,884,877,000587,000$4,915
EnbrelRheumatoid arthritis; Psoriasis; Psoriatic arthritis$2,791,105,00048,000$58,148
ImbruvicaBlood cancers$2,663,560,00020,000$133,178
StelaraPsoriasis; Psoriatic arthritis; Crohn’s disease; Ulcerative colitis$2,638,929,00022,000$119,951
Fiasp; Fiasp FlexTouch; Fiasp PenFill;
NovoLog; NovoLog FlexPen; NovoLog PenFill		Diabetes$2,576,586,000777,000$3,316

 
[Source: CMS, https://www.cms.gov/files/document/fact-sheet-medicare-selected-drug-negotiation-list-ipay-2026.pdf]

These ten drugs are among those with highest total spending in Medicare Part D – $50 billion in total part D gross covered drug cost s- or 20% of total part D gross covered drug costs june 1, 2022, may 31, 2023. More than 8 million Part D enrollees depend on these vital treatments to treat life-threatening conditions including diabetes, heart failure, and cancer, but many struggle to access their medications because of prohibitive costs.

Medicare drug price negotiation will result in lower out-of-pocket costs for seniors and will save money for American taxpayers. Negotiations for the first group of selected drugs will begin in 2023, with negotiated prices going into effect in 2026.

Out-of-Pocket Costs for Drugs Covered Under Part D Selected for Drug Price Negotiation, by State

Today HHS also released a report showing that 9 million Medicare Part D enrollees took the drugs covered under Part D selected for negotiation and paid a total of $3.4 billion in out-of-pocket costs for these drugs in 2022.  For enrollees without additional financial assistance, average annual out-of-pocket costs for these drugs were as high as $6,497 per enrollee in 2022.

To view a state-by-state breakdown of the number of Medicare enrollees who use the prescription drugs selected for negotiation and their out-of-pocket costs, visit HHS’s website.

Continuing to Lower Prescription Drug Costs

Every day, millions of seniors are saving money on prescription drug costs because of the Biden Administration’s actions. People with Medicare are saving an average of $70 in out-of-pocket costs on vaccines like shingles and Tdap because President Biden’s Inflation Reduction Act made recommended vaccines free for beneficiaries starting this past January. Nearly four million seniors and others on Medicare with diabetes started to see their insulin costs capped at $35 per month this past January, saving some seniors hundreds of dollars for a month’s supply. And some seniors taking drugs covered under Part B for which manufacturers have hiked prices faster than inflation are saving up to $449 in lower coinsurance this quarter thanks to the new Medicare inflation rebates.

People with Medicare will continue to see their prescription drug costs go down as more provisions of the Inflation Reduction Act go into effect in the coming years. Part D enrollees will no longer pay 5% co-insurance when they reach the catastrophic phase of their benefit starting in 2024. Nearly 19 million seniors and other Part D beneficiaries are projected to save $400 per year on prescription drugs when the out-of-pocket cap drops to $2,000 in 2025, and 1.9 million enrollees with the highest drug costs will save an average of $2,500 per year. And the lower prices negotiated for the high-spend drugs selected today will go into effect in 2026.

The President’s Budget for Fiscal Year 2024 builds upon the Inflation Reduction Act to continue lowering the cost of prescription drugs. For Medicare, this includes further expanding the newly established negotiation authority by extending it to more drugs and bringing drugs into negotiation sooner after they launch. The Budget also includes proposals to curb inflation in prescription drug prices and cap the prices of insulin products at $35 for a monthly prescription in the commercial market to lower drug costs for all Americans.

The ability to negotiate drug prices is historic. For decades, Big Pharma lobbyists (three for every one member of Congress) and Congressional Republicans stopped Medicare from saving taxpaying, hardworking families money by negotiating lower drug costs.

The result of that blockade was that Americans were forced to pay the highest prices for medicines in the world, despite the fact that taxpayers subsidize Big Pharma’s research and development.

“This is a game-changer for Americans who are being overcharged for medicines they need and a game-changer for Medicare because it will spend less taxpayer money to deliver the same benefits,” stated Deputy Press Secretary and Senior Communications Adviser Andrew Bates.

“This comes after President Biden also beat Big Pharma by capping the price of insulin at $35 per month for Medicare recipients. Big Pharma has spent nearly $400 million lobbying to stop these reforms.”

However, as the Biden Administration takes these newest historic actions to lower drug costs for Americans and strengthen Medicare, Congressional Republicans continue to side with Big Pharma’s price gouging and cuts to Medicare benefits instead.

Not only do congressional Republicans want to take the new benefits being announced today away from Americans with repeal legislation (just as they spent years trying to repeal the Affordable Care Act – Obamacare) – they are even siding with Big Pharma’s lawsuits to stop them in their tracks, Bates said.

Congressman Morgan Griffith endorsed their suits, saying, “every drug manufacturer probably ought to sue because it is, on its face, an unconstitutional taking.”

And reporters have frequently noted that in their opposition to this breakthrough for seniors, congressional Republicans are parroting Big Pharma’s talking points and “echoing arguments the pharmaceutical industry has made for years.”  

After unsuccessfully voting to block President Biden’s plan to let Medicare negotiate lower drug costs, Congressional Republicans have sought to repeal it, in alignment with Big Pharma. In the midterms, they campaigned on repealing Medicare’s new power but shut their ears to voters’ message back to them.

This summer alone, the Republican Study Committee, which represents over three quarters of House Republicans, unveiled yet another repeal plan.

The handouts Congressional Republicans are pursuing for Big Pharma would explode our deficit, weaken Medicare, and subject more American seniors and families to price gouging for life-saving medicines, Bates said. 

“Across the board, the hallmark of congressional Republicans’ trickle-down economic agenda is to increase costs and financial burdens shouldered by hardworking Americans in exchange for welfare payoffs to the super rich and multinational corporations. In this case, Big Pharma.

“Their philosophy is the polar opposite of Bidenomics, which is based on rewarding hard work and growing our economy by growing the middle class. Not leaching off the middle class for an extreme rightwing scheme to redistribute income upward.   

“We should be bolstering Medicare’s ability to lower drug costs for families, instead of trying to erase them.

“This fight is far from over. President Biden is pushing to expand Medicare’s capacity to negotiate lower drug costs, which he released a concrete plan for in his budget,” Bates said.

Biden Administration, Consumer Protection, Financial Protection, Health Care, Joe Biden, News & Photo Features

Biden Takes New Actions to Lower Health Care Costs and Protect Consumers from Scam Insurance Plans, Junk Fees as Part of ‘Bidenomics’ Push

Actions are the latest in a series of steps the Biden Administration has taken to eliminate hidden junk fees and lower prescription drug costs

President Biden announced a series of new actions under a core pillar of his “Bidenomics” agenda to lower health care costs and crack down on surprise junk fees for American families and consumers © Karen Rubin/news-photos-features.com

Today, President Biden announced a series of new actions under a core pillar of his “Bidenomics” agenda to lower health care costs and crack down on surprise junk fees for American families and consumers. Since the beginning of his Administration, President Biden has passed historic legislation to lower health care costs for tens of millions of Americans, took on Big Pharma to finally allow Medicare to negotiate lower prescription drug prices, and took action to eliminate hidden fees in every sector of the economy. Today, the Administration is taking additional steps to continue to deliver on those promises.

The President announced:

  • The Biden-Harris Administration is cracking down on junk insurance.  New proposed rules would close loopholes that the previous administration took advantage of that allow companies to offer misleading insurance products that can discriminate based on pre-existing conditions and trick consumers into buying products that provide little or no coverage when they need it most.  These plans leave families surprised by thousands of dollars in medical expenses when they actually  use health care services like a surgery.  If finalized, the rule would limit so-called “short-term” plans to truly short time periods, close loopholes made worse by the previous administration, and establish a clear disclosure for consumers of the limits of these plans.
     
  • The Administration is releasing important guidance on rules against surprise medical billing. Biden-Harris Administration rules are already preventing as many as 1 million surprise medical bills every month.  New guidance will help stop providers from gaming the system by evading the surprise billing rules with creative contractual loopholes that still leave consumers with unexpected costs.
     
  • The Administration is announcing new steps to protect consumers from unfair medical debt. For the first time in history, the Consumer Financial Protection Bureau, HHS, and Treasury are collaborating to explore whether health care provider and third-party efforts to encourage consumers to sign up for these products are operating outside of existing consumer protections and breaking the law. Medical credit cards and loans often lead to higher costs without consumers fully understanding the risks.
     
  • The Department of Health and Human Services is releasing a new report showing that nearly 19 million seniors and other Part D beneficiaries are projected to save $400 per year on prescription drugs when President Biden’s $2,000 out-of-pocket cap goes into effect. It’s also releasing state by state data that demonstrates how seniors across the country are helped by just one element of the President’s robust agenda to lower prescription drug prices.

These actions are the latest in a series of steps the Administration has taken to address hidden junk fees across industries, including: cracking down on bounced check and overdraft fees in the banking industry, which is saving consumers more than $5 billion every year; proposing rules to require airlines to disclose all of their fees up front and successfully pushing a number of airlines to end family seating fees; and mobilizing private sector action to eliminate hidden junk fees for concert and sports tickets.

Cracking down on junk insurance
The Affordable Care Act has helped tens of millions of Americans access high-quality, affordable health insurance and protects Americans from being discriminated against because of pre-existing conditions.  But actions from the previous administration allowed insurance companies to take advantage of loopholes in the law and sell “junk insurance” plans that evade these protections. These “junk insurance” plans leave families surprised by thousands of dollars in bills, often because the insurance plan claims they have a pre-existing condition that isn’t covered.  For example, a man in Montana faced $43,000 in health care costs because his insurance plan claimed his cancer was a pre-existing condition, and a Pennsylvania woman was surprised by nearly $20,000 in bills for an amputation her junk plan refused to cover.  Today, the Biden-Harris Administration is proposing rules to crack down on this junk insurance, as part of the latest efforts by the Administration to eliminate hidden and junk fees in every industry across the economy.  These actions will reduce scam insurance plans that offer really no insurance at all.

  • “Short-term” plans must be truly short-term.  Under the new rules, if finalized, plans that claim to be “short-term” health insurance would be limited to just 3 months, or a maximum of 4 months, if extended – instead of the 3 years that junk plans can offer today as a result of changes made by the previous administration.
     
  • Income replacement “fixed indemnity” plans cannot mimic comprehensive health insurance. Under the proposed rules, plans that want to be exempt from the rules for health insurance — because they are designed to replace lost income when people get sick, rather than provide full medical coverage – have to live up to their original purpose and cannot be designed like comprehensive health insurance. This means that plans would need to make clear that people signing up for these plans would get a defined benefit, like $100 per day of illness, instead of thinking that they have comprehensive insurance. This proposed rule aims to prevent Americans from being on the hook for high medical costs, like a woman who needed an amputation and was left with $20,000 in medical debt because her plan did not include comprehensive coverage.
     
  • Plans have to clearly disclose limits. Under the proposed rules, plans are required to provide consumers with a clear disclaimer that explains the limits of their benefits, including to existing consumers currently enrolled in these plans. 

Preventing surprise medical billing
Before President Biden took office, millions of people received surprise bills for health care they thought was in-network care covered by their health plan.  This could include when people need emergency care and are taken to the nearest hospital, or when a pregnant woman delivers her baby at an in-network hospitals only to find out that the anesthesiologist who cared for her is actually out-of-network.  These surprise bills can cost people hundreds or thousands of dollars, averaging between $750 to $2,600. The Administration is protecting millions of consumers from surprise medical bills through the implementation of the No Surprises Act, which has already protected 1 million Americans every month since January 1, 2022 from unfair, undeserved out-of-network charges and balance bills.
 
The Biden-Harris Administration is taking an important next step to protect consumers from surprise medical bills by issuing guidance to clarify that payers cannot use loopholes to avoid surprising billing protections:

  • Ending abuse of “in-network” designation. Today, some health plans contract with hospitals, but try to claim that they are not technically “in-network” – which can expose consumers to higher payments when they have to make a hospital visit.  The Administration today is making clear this is not allowed under federal law: health care services provided by these providers are either out-of-network and subject to the surprise billing protections, or they are in-network and subject to the ACA’s annual limitation on cost-sharing, further protecting consumers from excessive out-of-pocket costs.
     
  • Facility fees treated like other health care costs. The Administration is also concerned about an increase in patients being charged “facility fees” for health care provided outside of hospitals, like at a doctor’s office. These fees are often a surprise for consumers. The Administration today is making clear that health plans and providers must make information about these facility fees publicly available to consumers, as well as other price information for services and items they cover or provide. In addition, nonparticipating providers and nonparticipating emergency facilities cannot evade the protections of the No Surprises Act, including the prohibition on balance billing, by renaming charges otherwise prohibited under the No Surprises Act as “facility fees.”

Protecting consumers from unfair medical debt
Increasingly, health care providers are signing up patients for third-party medical credit cards and loans to help pay for care. These credit cards often include teaser rates and deferred interest features that lead to higher costs for consumers, and may be offered even when low- or no-cost alternatives, such as zero-interest payment plans, financial assistance, or health coverage may be available. Health care providers may be promoting these products because they could allow providers to get paid faster, outsource servicing and collections costs to third parties, receive a higher payment from consumers who otherwise would pay a discounted price for care, and in some circumstances, receive a share of the interest revenue gained by the third-party financial company.
 
Use of these products may complicate insurance coverage and the availability of financial assistance, and consumers may not fully understand the risks associated with these products, leading to higher costs and negative impacts on consumers’ financial, physical, and emotional well-being.
 
For the first time ever, the Consumer Financial Protection Bureau (CFPB), HHS, and Treasury are collaborating on the needs of health care consumers by releasing a Request for Information (RFI) to learn more about this emerging practice and solicit comment on potential policy actions. Part of this RFI will explore whether providers are operating outside of existing consumer protections, because once medical bills are placed on medical credit cards, there may be gaps in how various consumer protections apply. 

New data shows nearly 19 million seniors and other Medicare beneficiaries will save an estimated $400 per year in prescription drug costs because of President Biden’s out-of-pocket spending cap
Thanks to President Biden’s Inflation Reduction Act, out-of-pocket spending on prescription drugs at the pharmacy will be capped at $2,000 per year for Medicare Part D enrollees starting in 2025.  Today, the Department of Health and Human Services (HHS) released data showing that 18.7 million (or 1 in 3) seniors and people with disabilities who are enrolled in Part D plans will save, on average, $400 per year when the $2,000 cap and other Inflation Reduction Act provisions go into effect in 2025. And some enrollees will save even more: 1.9 million enrollees with the highest drug costs will save an average of $2,500 per year starting in 2025. Overall, the law’s Part D benefits provisions will reduce enrollee out-of-pocket spending by about $7.4 billion annually.
 
To view data broken down by state and demographic, visit LINK.
 
Today’s actions follow significant milestones achieved last week in implementing President Biden’s historic law to lower health care and prescription drug costs. On June 30, the Centers for Medicare and Medicaid Services released revised guidance that describes how they will negotiate lower prescription drug prices for seniors later this year. The first ten drugs selected for negotiation will be announced by September 1, 2023. Also last week, the $35 monthly cap on insulin for Medicare Part B beneficiaries went into effect. Already 1.5 million Medicare Part D beneficiaries were saving up to hundreds of dollars per month on insulin costs because of the Inflation Reduction Act, and many more will benefit from these cost savings starting this month.
  

Biden Administration, Health Care

Biden Acts to Lower Health Care and Prescription Drug Costs for Americans

This is a fact sheet from the White House on actions President Biden has taken to lower health care and prescription drug costs:

To mark the start of Medicare Open Enrollment season, President Biden highlighted how seniors can take advantage of the Inflation Reduction Act’s cost-saving provisions as they shop for new health insurance plans. The President also signed an Executive Order directing the Department of Health and Human Services to explore additional actions it can take to lower prescription drug costs to build on his Administration’s work lowering costs for working and middle-class families © Karen Rubin/news-photos-features.com

To mark the start of Medicare Open Enrollment season, President Biden highlighted how seniors can take advantage of the Inflation Reduction Act’s cost-saving provisions as they shop for new health insurance plans. The President also signed an Executive Order directing the Department of Health and Human Services to explore additional actions it can take to lower prescription drug costs to build on his Administration’s work lowering costs for working and middle-class families.
 
Americans are squeezed by the cost of living – that’s been true for years and is a key reason the President ran. Health care costs in particular are driving inflation. Too many Americans face challenges paying for prescription drugs. On average, Americans pay two to three times as much as people in other countries for prescription drugs, and one in four Americans who take prescription drugs struggle to afford their medications. Nearly three in ten American adults who take prescription drugs say that they have skipped doses, cut pills in half, or not filled prescriptions due to cost.
 
The Inflation Reduction Act – which President Biden and Congressional Democrats delivered – tackles that problem and locks in on average $800 per year lower health care premiums for 13 million families, lowers seniors’ prescription drug prices, and caps their out of pocket expenses for prescription drugs at $2,000 per year. The Inflation Reduction Act protects Medicare beneficiaries from catastrophic drug costs by phasing in a cap for out-of-pocket costs at the pharmacy, establishing a $35 monthly cap per prescription of insulin, requiring companies who raise prices faster than inflation to pay Medicare a rebate, and allowing Medicare to negotiate prices for high-cost prescription drugs for the first time ever. Republicans in Congress, meanwhile, have said their top priority is to repeal the Inflation Reduction Act, ending these cost-saving provisions and raising prices for tens of millions of Americans.
 
To further lower health care costs, earlier this week, the Treasury Department took action to fix the so-called “family glitch” rule that was making it harder for families to afford health care coverage for their spouse or child. About 1 million Americans will either gain coverage or see their insurance become more affordable as a result of the new rule.
 
Lowering Medicare Costs This Open Enrollment Season
 
Starting this January, seniors and other Medicare beneficiaries will begin to see the benefits of these cost-saving measures. Because of the Inflation Reduction Act:

  • A month’s supply of insulin will be capped at $35 starting on January 1, 2023.
  • Medicare beneficiaries will pay $0 out of pocket for recommended adult vaccines covered by their Part D plan, including the shingles vaccine – which costs seniors up to $200.
  • Prescription drug companies that try to raise their prices faster than inflation will be required to pay Medicare a rebate. 

Earlier this year, HHS released a report showing that the price of 1,200 prescription drugs rose faster than inflation in just the last year. For example, one manufacturer of a drug used to treat high blood pressure and heart failure, used by millions of Medicare beneficiaries, increased the drug’s price by nearly 540 percent in 2022. Another drug used to treat autoimmune conditions increased by $1000 just this year.
 
During Medicare Open Enrollment – running from October 15 to December 7 – seniors and other beneficiaries will be able to choose drug coverage that reflects these new cost-savings, putting money back into their pockets.
 
Medicare beneficiaries should visit Medicare.gov or call 1-800-MEDICARE to review their options for the coming year, and make sure their health and prescription drug coverage is right for them. 
 
Using HHS’ Innovation Center to Further Bring Down Costs
 
As the Biden-Harris Administration works to implement the Inflation Reduction Act, President Biden will sign an Executive Order today directing the Department of Health and Human Services to consider additional actions to further drive down prescription drug costs. That includes leveraging the “Innovation Center” at HHS, created by the Affordable Care Act, which has authority to test new ways of paying for Medicare services that improve the quality of care while lowering costs. 
 
Under the Executive Order, HHS will have 90 days to submit a formal report outlining any plans to use the Innovation Center’s authorities to lower drug costs and promote access to innovative drug therapies for Medicare beneficiaries. This action would build on the Inflation Reduction Act’s landmark drug pricing reforms and help provide additional breathing room for American families.

Democrats 2020, Election 2020, Health Care

Democratic Race for 2020: Biden Issues Plan to End Opioid Crisis, Ensure Access to Treatment and Recovery

Vice President Joe Biden, running for the 2020 Democratic nomination for president, has released his plan for ending the opioid crisis and ensuring access to effective treatment and recovery for substance use disorders. © Karen Rubin/news-photos-features.com

The vigorous contest of Democrats seeking the 2020 presidential nomination has produced excellent policy proposals to address major issues. Vice President Joe Biden has released his plan for ending the opioid crisis and ensuring access to effective treatment and recovery for substance use disorders. This is from the Biden Campaign:

Millions of families are impacted by the opioid crisis. It’s ravaging communities coast to coast, from New Hampshire to California. The challenge of substance use disorders is not limited to opioids. Millions of individuals are affected by misuse of other substances such as alcohol or methamphetamine. Latest estimates indicate that, in 2018, almost 68,000 Americans died from a drug overdose – almost 47,000 of which involved an opioid. And, the impacts of this crisis reverberate in our classrooms and neighborhoods, in small towns and big cities.
 
Biden will tackle this crisis by making sure people have access to high quality health care – including substance use disorder treatment and mental health services. That’s what Obamacare did by designating substance use disorder treatment and mental health services as essential benefits that insurers must cover, and by expanding Medicaid, the nation’s largest payer for mental health services which also plays an increasingly growing role as a payer for substance use disorder services.
 
But President Trump wants to repeal Obamacare, including its Medicaid expansion. Repeal would be disastrous for communities and families combating the opioid crisis. It is not realistic to think that grant money will fill the hole that eliminating Obamacare and its Medicaid expansion would create.
 
Step one of Biden’s plan to tackle the opioid epidemic and substance use disorders is to defeat Trump and then protect and build on Obamacare. And, Biden will pursue a comprehensive, public health approach to deal with opioid and other substance use disorders. His plan will:

Hold accountable big pharmaceutical companies, executives, and others responsible for their role in triggering the opioid crisis.

Make effective prevention, treatment, and recovery services available to all, including through a $125 billion federal investment.

Stop overprescribing while improving access to effective and needed pain management.

Reform the criminal justice system so that no one is incarcerated for drug use alone.

Stem the flow of illicit drugs, like fentanyl and heroin, into the United States – especially from China and Mexico.


HOLD ACCOUNTABLE BIG PHARMA COMPANIES, EXECUTIVES, AND OTHERS RESPONSIBLE FOR THEIR ROLE IN TRIGGERING THE OPIOID CRISIS
 
Biden will demand accountability from pharmaceutical companies and others responsible for the opioid crisis, including manufacturers, distributors, and “pill mill operators.” Pharmaceutical executives should be held personally responsible, including criminally liable where appropriate. Specifically, Biden will:

Direct the U.S. Justice Department to make actions that spurred this crisis a top investigative and, where appropriate, civil and criminal enforcement priority. Biden will make sure the Department has all the necessary resources to complete this work. Building on the efforts of the Obama-Biden Administration, Biden will also ensure the Food and Drug Administration takes action when new information reveals harms from previously approved drugs (including the risk of diversion, or the use of drugs by an individual other than the one to whom the drug was prescribed), ensures compliance with risk mitigation strategies, and punishes drug companies for deceptive practices. And, he will appoint an Opioid Crisis Accountability Coordinator to coordinate efforts across federal agencies and support the enforcement efforts of state and local partners.

Direct the Drug Enforcement Administration (DEA) to step up its efforts to identify suspicious shipments and protect communities. Opioids distributors knowingly shipped millions of pills to towns with hundreds of residents, helping trigger the opioid epidemic. Biden will empower the DEA to stop drug shipments from pharmaceutical companies and their distributors that create risks of diversion and misuse. Biden will work with Congress to allow the DEA to act expeditiously when a pharmaceutical distributor fails to adequately monitor shipments that could pose an “imminent danger” to vulnerable communities and increase penalties for companies that fail to take action to stop suspicious shipments. In addition, Biden will direct the DEA to improve data collection on wholesalers and pharmacies, including prescribing patterns and suspicious order reports, and to disseminate its analysis to distributors to prevent problems before they become disasters.

Ban drug manufacturers from providing payments or incentives to physicians and other prescribers. Pharmaceutical companies work hard to persuade doctors and other medical personnel to prescribe their products. These companies essentially pay providers to prescribe opioids and other drugs by, for example, paying providers to speak at or attend conferences, or consult for their companies. By banning these practices, Biden will ensure that patients’ lives do not take a backseat to doctors’ bottom lines.

Terminating pharmaceutical corporations’ tax break for advertisement spending. Drug corporations spent an estimated $6 billion in 2016 alone on prescription drug advertisements to increase their sales, a more than four-fold increase from just $1.3 billion in 1997. The American Medical Association has even expressed “concerns among physicians about the negative impact of commercially driven promotions, and the role that marketing costs play in fueling escalating drug prices.” Currently, drug corporations may count spending on these ads as a deduction to reduce the amount of taxes they owe. But taxpayers should not have to foot the bill for these ads. As President, Biden will end this tax deduction for all prescription drug ads, as proposed by Senator Jeanne Shaheen.

 
MAKE EFFECTIVE PREVENTION, TREATMENT, AND RECOVERY SERVICES AVAILABLE TO ALL WHO NEED THEM
 
Biden has long recognized and led on efforts to make clear that substance use disorders are diseases, not a lifestyle choice, and that we need to change how we talk about and treat substance use disorders to align with this fact.
 
He knows that the most important step we can take to address substance use disorders is to ensure that Americans have access to affordable, high-quality health care, including treatment for mental illnesses and substance use disorder. That’s why Biden has a plan to build on the Affordable Care Act and achieve universal coverage. In addition, Biden will redouble efforts to ensure insurance companies stop discriminating against people with behavioral health conditions and instead provide the coverage for treatment of mental illness and substance use disorders that patients and families need. Congress passed a bipartisan parity law 12 years ago requiring that this discrimination stop, but the enforcement of parity has been insufficient. As Vice President, Biden championed efforts to implement the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act. As President, he will finish the job by appointing officials who will hold insurers accountable, enforcing our parity laws to the fullest extent. He will also direct federal agencies to issue guidance making clear how state officials and the public can file a complaint when their insurers – or Medicaid – are not living up to their parity obligations.
 
In addition, Biden will work to make sure that people experiencing substance use disorders have access to quality facilities and providers. As President, he will ensure that the new public option, Medicare, Medicaid, the Indian Health Service, the Military Health System, and the Veterans Health Administration accelerate integration of substance use disorder care into standard health care practice. Biden will double funding for community health centers and expand the supply of health care providers, for example by growing the National Health Service Corps. And, he will protect rural hospitals from payment cuts, give them the flexibility they need to remain open, and invest in telehealth so people in remote areas can still have access to mental health and substance use disorder specialists.

Finally, Biden will make sure federal funds are specifically targeted at improving access to treatment and recovery for opioid and other substance use disorders, and at preventing these disorders in the first place. As Vice President, Biden championed passage of the 21st Century Cures Act, which included $1 billion in funding for states to address the opioid epidemic. That was a down payment. To deal with the immense scope of the opioid and substance use disorder crisis, Biden will dramatically scale up the resources available, with an unprecedented investment of $125 billion over ten years. Funds will be used to:

Pursue comprehensive strategies to expand access to treatment, particularly in rural and urban communities with high rates of substance use disorders and a lack of access to substance use disorder treatment services. Biden will invest $75 billion in flexible grants to states and localities for prevention, treatment, and recovery efforts. State and local agencies will also be able to use funds to enhance data systems allowing them to better target resources to individuals and communities most in need of support. As a condition for receiving funding, grant recipients will have to provide long-term, comprehensive strategic plans that address the multifaceted nature of the substance use disorder crisis. Funds may be used to:

Invest in evidence-based, cost-effective prevention programs in schools and communities to reduce the development of substance use disorders.

Mitigate harms from opioid and other drug use, including overdoses. Local communities will be able to use the funds to implement evidence-based programs designed to stop the spread of diseases like hepatitis C and HIV, including syringe service programs, or to scale up innovative programs like the safe station initiative started in Manchester, New Hampshire, which allows those seeking help to go to fire stations in order to be connected to treatment and recovery services.

Expand access to ongoing treatment and recovery services. Communities will be able to use funds to increase access to substance use disorder and mental health treatment and other services to support long-term recovery, including peer support networks and recovery coaches, and better integrate primary care and behavioral health. Recognizing the strong evidence that social supports, including family support, may have a positive impact on the treatment of HIV, Biden will support the development of family-centered models for substance use disorder treatment and recovery.

Make Medication Assisted Treatment (MAT) available to all who need it, reaching universal access no later than 2025. MAT (also referred to as MOUD or Medications for Opioid Use Disorder) is regarded as the gold standard of care for individuals with opioid use disorder. Yet, less than 50% of substance use disorder facilities around the country offer even one of the FDA-approved medications. The 21st Century Cures Act, legislation Biden championed as Vice President, provided resources to states designed to expand access to MAT.  Biden will build on this in order to ensure universal access to MAT for all who need it, including by:

Providing $20 billion for grants to dramatically expand capacity to administer MAT across the country, especially in underserved areas, including establishing new facilities and developing training programs to increase the number of professionals able to administer MAT.

Stopping insurance companies from erecting barriers to coverage of MAT. For example, insurers have imposed “fail first” protocols which require prescribers to certify that other therapies were tried before covering MAT. Insurers also may require that physicians obtain “prior authorization” for MAT before prescribing it.   

Removing undue restrictions on prescribing medications for substance use disorder. For example, drugs containing buprenorphine were approved by the FDA in 2002 but a relatively small number of doctors or medical personnel are certified to prescribe them. Biden will ensure that any undue restrictions on prescribing are lifted and review methadone treatment regulations.

Help first responders and community health providers respond to overdoses. Biden will invest $10 billion to provide local communities with the tools needed to prevent overdoses and respond to emergencies emanating from this crisis. 

Ensure local communities have a sufficient supply of overdose prevention drugs. Naloxone (also known as Narcan) is a medication that can reverse an opioid overdose, making it a critical tool in the fight to save lives. Biden will expand grants to states for the purchase of Naloxone to be distributed to local community actors called upon to respond to overdoses, including first responders, public health providers, and the staff at homeless shelters and public libraries.

Demand that drug companies charge a fair price for overdose drugs, including Naloxone. The Biden Administration will aggressively negotiate a reduction in the drug’s price, on behalf of the federal government, and state and local communities.

Support first responders. Police officers and firefighters are often the first on the scene of an overdose. Biden will ensure they are equipped not just with naloxone, but also with the mental health and resilience support anyone would need after being exposed again and again to such trauma.

Invest in community-based prevention programs and a major public education effort to eliminate the stigma surrounding substance use disorder treatment. Biden will invest $5 billion in community-based prevention efforts and public education initiatives including training educators to recognize the signs of mental health problems and substance use disorders and refer them to appropriate services. Funds will also support evidence-based education programs for young people on mental health and substance use disorders.

Expand the pipeline of medical personnel to treat substance use disorders. Building on legislation like the Opioid Workforce Act of 2019, Biden will work with Congress to invest $5 billion to expand medical residencies and access to education and training for medical personnel in substance use disorder diagnosis and treatment. Funding will support training for primary care providers, as well as other members of the health care team, to build an integrated system of care.

Invest in research by doubling funding for the NIH HEAL (Helping to End Addiction Long-Term) Initiative. This $10 billion investment will support efforts to improve treatments for chronic pain.

Provide targeted interventions for particular populations. Biden will invest $10 billion in efforts specifically designed to support populations with unique situations or needs. Biden will ensure a portion of this funding for state and local governments is set aside for Tribal governments. In addition to expanding veterans’ access to substance use disorder and mental health treatment, Biden will direct his Secretary of Veterans Affairs to ensure VA medical personnel are sufficiently trained in safe prescribing practices and pain treatment. Biden will call upon the public health and criminal justice systems to provide evidence-based substance use disorder treatment, including MAT, for people during their incarceration and after their release. Finally, Biden will expand investments to help children suffering from Neonatal Abstinence Syndrome or Neonatal Opioid Withdrawal Syndrome, and to ensure their mothers have access to effective treatment and care.


STOP OVERPRESCRIBING WHILE IMPROVING ACCESS TO EFFECTIVE AND NEEDED PAIN MANAGEMENT
 
An essential part of our national strategy to address the opioid epidemic must be stopping pharmaceutical companies’ practices that lead to overprescribing. Yet at the same time, physicians still must effectively treat pain. Chronic pain is a growing public health challenge with wide-ranging impacts: keeping individuals out of the workforce, negatively affecting their mental and physical health, contributing to suicidal ideation, and otherwise limiting their quality of life. Biden believes we need to pursue two joint goals: eliminate overprescribing of prescription opioids for pain, and improve the effectiveness of and access to alternative treatment for pain. Biden will:

Support development of less addictive pain medications and alternative pain treatments, and improve standards of quality for treatment. We need pain medications that are less addictive and more effective. Biden will invest in NIH research to develop these new medications. By doubling funding for NIH’s HEAL program, Biden will accelerate research regarding alternative treatments and therapies and help providers and patients better understand the options and access alternatives. And, he will direct the FDA to give priority to new pain medications with a documented reduced risk of addiction. 

Expand coverage for alternative pain treatments. As documented in a recent study related to back pain, some non-pharmacological pain interventions (e.g., psychological counseling, acupuncture, physical therapy, or occupational therapy) are not consistently covered or have administrative barriers to coverage (e.g., pre-authorization, visit limits). In accordance with evidence-based medicine, Biden will call for a requirement that Medicare, Medicaid, his proposed new public option, and private insurance companies consistently and transparently cover alternatives to opioids for chronic pain, without barriers such as prior authorization or high levels of cost-sharing.

Crack down on misleading advertising regarding substance use disorder treatment facilities with no basis in evidence. Biden will ensure that the Federal Trade Commission and the FDA act when companies try to mislead. He will appoint leaders of both agencies who will make this a key priority.

Provide training to medical personnel in pain management and substance use disorder treatment. Building on the Obama-Biden Administration’s prior efforts, Biden will direct the U.S. Department of Health and Human Services to work with the medical community to support research and the development of curricula and training regarding pain management. He will ensure that the systematic study of pain management and substance use disorder is a mandatory part of the curricula and material on which doctors and other medical personnel are tested. Those seeking a federal DEA license to prescribe controlled substances will be required to receive training on proper prescribing guidelines and pain management.

Expand the effectiveness of monitoring programs designed to prevent inappropriate overprescribing of opioids. Prescription Drug Monitoring Programs (PDMPs) are electronic databases designed to prevent drug abuse. For example, a provider can check the database before prescribing in order to determine whether his or her patient has been getting the same prescription from multiple providers. In order to receive any of the $125 billion in new grants under the Biden Administration, states will have to institute a requirement that every prescriber checks the database every time they write a new opioid prescription. Biden will also set aside some of these grant dollars to ensure states improve Prescription Drug Monitoring Programs data-sharing across state lines.

Ensure regular updating of the Centers for Disease the Control and Prevention (CDC) prescriber guideline based on the best available evidence. The CDC has issued a guideline to help prescribers make evidence-based decisions regarding when and how to prescribe opioids in order to minimize the risk of abuse while also effectively treating pain. Biden will ask the CDC to commit to regularly updating these guidelines as new evidence emerges regarding opioid abuse risk factors and alternative pain treatments. And, he will partner with health care providers and states to maximize providers’ awareness and use of the guideline.

 
REFORM THE CRIMINAL JUSTICE SYSTEM SO THAT NO ONE IS INCARCERATED FOR DRUG USE ALONE
 
Biden has released a criminal justice plan that will strengthen America’s commitment to justice and reform our criminal justice system by building a system focused on redemption and rehabilitation. Biden believes that no one should be incarcerated for drug use alone, and as President he will treat drug use as a disease rather than a crime. Specifically, Biden will:

End all incarceration for drug use alone and instead divert individuals to drug courts and treatment. Biden will require federal courts to divert these individuals to drug courts so they receive appropriate treatment and services. He’ll incentivize states to put the same requirements in place. And, he’ll expand funding for federal, state, and local drug courts and other programs that divert individuals who commit crimes as a result of or in furtherance of substance use disorders to treatment rather than incarceration. 

Get people who should be supported with social services – instead of in our prisons  – connected to the help they need. Too often, those in need of mental health care or treatment for a substance use disorder do not get the care that they need. Instead, they end up having interactions with law enforcement that lead to incarceration. To change the nature of these interactions, the Biden Administration will fund initiatives to partner mental health and substance use disorder experts, social workers, and disability advocates with police departments. These service providers will respond to calls with police officers so individuals who should not be in the criminal justice system are diverted to treatment for substance use disorder or mental illness, when appropriate, or are provided with the housing or other social services they may need.

Read more about Biden’s plan to reform the criminal justice system at https://joebiden.com/justice/.
 
STEM THE FLOW OF ILLICIT DRUGS LIKE FENTANYL, ESPECIALLY FROM CHINA AND MEXICO
 
As part of a comprehensive agenda that prioritizes prevention, treatment, recovery, and harm reduction, Biden believes that part of the solution to the opioid crisis involves preventing bad actors from smuggling opioids and other illicit drugs into our country. Specifically, Biden will:

Make fentanyl a top priority in our dealings with China. The Treasury Department has already sanctioned a small number of Chinese nationals in connection with fentanyl – it’s a good start, but going after individuals will not alter Beijing’s thinking long-term. Biden will pressure Beijing to crack down on illicit fentanyl production in China and stem the flow of the drug into the United States. Biden will also develop regional strategies in the Asia-Pacific and the Americas to deal with shifts in the routes and sources of fentanyl in response to a Chinese crackdown.

Enhance cooperation with Mexican authorities to disrupt the movement of heroin and fentanyl across the U.S.-Mexico border.  Chinese fentanyl is frequently transshipped through Mexico, and then smuggled across the border in pure form or combined with heroin. As China takes steps to police fentanyl and its precursors, production and distribution will increasingly shift to Mexico. Biden will pursue strong, sustained cooperation with Mexican authorities to disrupt suppliers and supply routes, including the importation of precursor chemicals from China. The Biden Administration will also provide technical assistance to enhance the Mexican Post Service’s (SEPOMEX) ability to detect and electronically track shipments of fentanyl and precursors that come through Mexico. As President, Biden will repair the damage to U.S.-Mexico ties inflicted by Donald Trump and develop a common agenda with Mexico that looks beyond our shared border to promote our shared prosperity and protect U.S. national security interests.

Enforce sanctions on international actors engaged in the trafficking of illicit drugs like heroin and fentanyl. Biden’s Treasury Department sanctions team will map the financial institutions and networks that facilitate the distribution of fentanyl and key precursors and develop sanctions packages based on that evidence and task the Office of the Director of National Intelligence to support these efforts with a focus on illicit finance.

Increase cooperation among global law enforcement agencies. Biden will direct U.S. law enforcement agencies to work closely with foreign counterparts, share threat information, and use technology to assist in tracking and seizing illicit shipments.

Ensure federal agencies have the tools and resources they need to stop the flow of fentanyl from abroad. Fentanyl producers have exploited gaps in monitoring through the U.S. Postal Service (USPS) to flood the U.S. with the deadly product. Biden will give the USPS the tools and resources it needs to carry out that mandate and disrupt the large supplies of fentanyl that are sent through the mail system, working with U.S. Customs and Border Protection. In addition, the vast majority of opioids and fentanyl are shipped through legal ports of entry—not in between them. Rather than waste resources building a wall or tearing families apart, Biden will direct resources to the ports of entry to interdict opioid shipments there.

Combating the Opioid Epidemic and Substance Use Disorders, Paid for By Making Sure Pharma Pays Its Fair Share
 
Biden’s $125 billion investment in a comprehensive response to the opioid epidemic and substance use disorders is paid for by raising taxes on the profits of pharmaceutical corporations.

Election 2020, Health Care

Bernie Sanders Defends Medicare-for-All, Attacks Insurance Companies, Big Pharma for Dysfunctional, High-Cost Healthcare

Bernie Sanders, seen at a Brooklyn rally, is defending his signature plan, Medicare-for-All, and blaming the greed of the insurance and pharmaceutical industries as the reason for dysfunctional, high cost health care system that causes 30,000 premature deaths a year and bankrupts 530,000 Americans a year. © Karen Rubin/news-photos-features.com

WASHINGTON – U.S. Senator Bernie Sanders, running to be the Democratic nominee for president, on July 17 delivered a major address on Medicare for All, coinciding with the 54th anniversary of Medicare being signed into law. In his remarks, Sanders outlined his plan to make health care a human right for all Americans. Here is highlighted transcript of remarks as they were prepared for delivery: – Karen Rubin, News & Photo Features

Thank you all very much for being here to discuss one of the major crises facing our country.  Let me also thank the dozens of organizations throughout America who support Medicare for All and the tens of thousands of doctors, nurses and other health professionals who support my legislation.  Let me thank the 14 Senate co-sponsors that we have on this legislation and the 118 Members of the House who support similar legislation.  And mostly, let me thank the American people who by the millions understand, as I do, that health care is a human right, not a privilege.

Together, we will end the international embarrassment of the United States being the only major country on earth that does not guarantee health care to all of its citizens.  

It is not acceptable to me, nor to the American people, that some 87 million people today are either uninsured or underinsured.

It is not acceptable to me that we end up spending almost twice as much as any other major country on health care, while our life expectancy continues to decline and our healthcare outcomes lag behind many other countries.

Frankly, I am sick and tired of talking to doctors who tell me about the patients who died because they were uninsured or underinsured, and walked into the doctor’s office when it was too late.  And we are talking about over 30,000 Americans who die every year because they are uninsured or under-insured.  What a tragedy. 

I am sick and tired of seeing working class families and small businesses pay far more for healthcare than they can afford, and 530,000 Americans declare bankruptcy each year because they cannot pay off the outrageous cost of a medical emergency or a hospital stay.  Families should not be driven into financial ruin because someone in the family became seriously ill.  How insane is that?

I am sick and tired of hearing from Americans who lost loved ones because they could not afford the unbelievably high cost of prescription drugs, or hearing from constituents who are forced to cut their pills in half due to the cost. 

In fact, later this month, I will be travelling from Detroit, Michigan to Windsor, Ontario with a busload of Americans who have diabetes in order to purchase insulin in Canada at one-tenth of the price that they pay in America.

I am sick and tired of talking with people who are struggling with mental illness but cannot afford the mental health counseling they desperately need. 

I am tired of talking to people who have teeth that are rotting in their mouths, but cannot afford the high cost of dental care. 

Let me be very honest and tell you that, in my view, the current debate over Medicare for All really has nothing to do with healthcare.  It has everything to do with greed and the desire of the healthcare industry to maintain a system which fails the average American, but which makes the industry tens and tens of billions of dollars every year in profit. 

It is about whether we maintain a dysfunctional system which allows the big drug and health insurance companies to make over $100 billion in profits last year, while the top CEOs in that industry made $2.6 billion in total compensation – all the while 1 out of 5 Americans cannot afford the prescription drugs their doctors prescribe.

It’s about whether we maintain a system in which the CEO of the Aetna insurance company, Mr. Mark Bertolini, received a golden parachute worth nearly $500 million after his company merged with CVS Health, while elderly people lack the resources to purchase a hearing aid.

It’s about whether we maintain a system that allows the former CEO from Gilead (John Martin) to become a billionaire by charging $1,000 a pill for a hepatitis c drug called Sovaldi that costs a dollar to manufacture.

Let us make no mistake about it.  The struggle that we are now undertaking, to guarantee health care to all Americans as a right and to substantially lower the cost of prescription drugs, will be opposed by some of the most powerful forces in America – entities that have unlimited amounts of money.  We’re talking about the insurance companies, the drug companies, private hospitals, medical equipment suppliers, Wall Street and other powerful entities.  

Let me make a prediction. In order to defeat the Medicare for All movement, powerful special interests will be spending millions on 30 second television ads, full page magazine ads, and corporate-sponsored “studies” to frighten the American people about Medicare for All – which is exactly what happened before the passage of Medicare in the 1960s. They failed then and they’re going to fail now.

And let me give you an example of the kind of money and power we are talking about. 

Over the last 20 years, the insurance industry and pharmaceutical companies have spent more than $330 million in campaign contributions and over $4 billion in lobbying to get Congress to do its bidding. 

The pharmaceutical industry alone has hired some 1,200 lobbyists – including the former leadership of both political parties.

I find it quite interesting that Billy Tauzin, the Republican Congressman who wrote the bill to prevent Medicare from negotiating for lower drug prices and then went on to become the President and CEO of Pharma, received over $11.6 million in compensation in 2010.

That’s how business is done in Washington.  Well, I have a different vision of what a rational healthcare system is all about.  Instead of massive profits for the drug companies, the insurance companies and Wall Street, we must provide a healthcare system that provides quality healthcare to all in a cost effective way.

And that is exactly what Medicare for All does.

Under this legislation, every family in America would receive comprehensive coverage, and middle-class families would save thousands of dollars a year by eliminating their private insurance costs as we move to a publicly funded program.

The transition to the Medicare for All program would take place over four years. In the first year, benefits to older people would be expanded to include dental care, vision coverage and hearing aids, and the eligibility age for Medicare would be lowered to 55. All children under the age of 18 would also be covered. In the second year, the eligibility age would be lowered to 45 and in the third year to 35. By the fourth year, every man, woman and child in the country would be covered by Medicare for All.

Medicare for All will reduce – let me repeat, reduce — overall health care spending while lowering the number of uninsured and underinsured people in this country to zero.   

We accomplish this because Medicare for All creates a system of health care insurance that isn’t designed to generate profits for insurance and drug companies — it will be a system focused on delivering actual health care. It will save lives, save money, and end the frustration of endless paperwork, denials, and desperate fights with an insurance company to cover medically-necessary medications and procedures.

Medicare for All will fully eliminate health insurance premiums, deductibles and co-payments. Make no mistake about it: These are nothing less than taxes on the middle class. 

And when we do that, the average middle class family will save an estimated $3,000 each and every year.

Further, unlike the current dysfunctional system, Medicare for All allows people the freedom to choose any doctor, clinic, and hospital without worrying about whether their provider is in-network or not.  People will be able to make the health care choices that are best for themselves and their families without some insurance bureaucrat telling them which providers they can see or not see. Medicare for All is at the end of the day empowering patients and health care providers. 

In addition, a Medicare for All system will allow us to address the serious problem of medically underserved areas. 

Just to demonstrate how absurd our health care system is, I was in Philadelphia two days ago rallying with the people of that city to try to stop the closure of Hahnemann University Hospital, an important, safety net hospital in that community.  Why do the owners want to close this hospital? Because they can make more money redeveloping that property into condominiums and hotels.

Let me address some of the half-truths, misinformation, and, in some cases, outright lies that people may be hearing about Medicare for All.  

Medicare for All critics tell us that Americans just love their private health insurance companies. We heard this most recently from UnitedHealth CEO David Wichmann, who by the way, made $83 million in 2017 and who said Medicare for All would “destabilize the nation’s health system.” 

But let’s remember: the current system is already disrupting and destabilizing millions of people’s lives. In the current system, 50 million Americans every year lose their existing health insurance when their employer changes insurer, when they change jobs, or when they cannot afford their current plan. For many of them, they will no longer be able to see the doctor they have relied on for years.  For others, important treatments for long-term conditions or disabilities will be changed or stopped altogether.  

Here is the simple truth. The American people do not like their private health insurance companies. In fact private health insurance companies are quite unpopular.  What the American people do like are their doctors, nurses and other health care providers. 

While our opponents claim that Medicare for All is too expensive, the reality is that it is much more cost effective than our current system.

The Center for Medicare and Medicaid Services estimates that, if we do not change the system, this country will be spending $50 trillion over the next ten years –19.4 percent of our nation’s GDP.  This is unsustainable and will be incredibly harmful to the people of our country, to the business community, and to the entire economy.

And the reason why we spend so much is obvious.  It is not just the huge profits in the insurance industry and the pharmaceutical industry, but it is the incredible and wasteful bureaucratic maze developed by thousands of different healthcare plans.  Today, hospitals and doctors must deal with patients who have different deductibles, different co-payments, different networks of coverage, and different coverage for pharmaceuticals, or no insurance at all.  All of this is not only driving doctors and nurses and hospital administrators to distraction, but it is wasting up to $500 billion a year on unnecessary administrative costs.

Unlike our current system, there is broad consensus – from conservative to progressive economists – that Medicare for All would result in substantial savings to the American people.  Two of the most recent studies on this issue have estimated that Medicare for All would save the American people between $2 trillion and $5 trillion over a 10-year period.

Let us be clear, the fight against Medicare for All today is not a new development.  Powerful special interests have always opposed healthcare programs that work for the people and not for corporate interests.

Let us not forget that when President Harry Truman first proposed a program guaranteeing health care to seniors that idea was billed as radical, “un-American,” and an attack on basic freedom. And because of that assault, the idea stalled in Congress for years — until voters made their voices heard.

In 1960, America elected John F. Kennedy after he campaigned in support of Truman’s idea. That election prompted serious work on universal health care bill, and Kennedy at the time noted that “what we are now talking about doing, most of the countries of Europe did years ago.”

Finally, following the 1964 Democratic election landslide, the new Congress was able to pass what is now known as Medicare despite intense opposition from the health insurance industry and the pharmaceutical companies.

More than a half-century after that achievement, the time is now to go forward.  The time is now to expand Medicare to every man, woman and child in this country. 

Let us be very clear.  When it comes to health care, the insurance and drug industries have been able to control the political process.  

If we are going to break the stranglehold of corporate interests over the health care needs of the American people, we have got to confront a Washington culture that is corrupt, that puts profits before people.

That is why I am calling on every Democratic candidate in this election to join me in rejecting money from the insurance and drug industries. That means not accepting donations over $200 from health insurance or pharmaceutical company PACs, lobbyists or executives. Candidates who are not willing to take that pledge should explain to the American people why those corporate interests believe their campaigns are a good investment.

Of course, President Trump should do the same but I am not going to even waste my breath suggesting that he will.  His efforts to throw 32 million people off their health insurance to have it replaced with junk insurance shows exactly what side he is on.

Finally, let me say, eliminating health insurance and drug company money from the Democratic primary won’t solve all the problems, but it is an important step forward. Now is the time to tell the health care industry that your profits are not more important than the lives of the American people.

See also: Biden Plan for Universal Healthcare: Protect, Build on Obamacare

Health Care

Reining in Big Pharma – or Why Capitalism Doesn’t Work With Life-Saving Drugs

How much is your child’s life worth? Big Pharma is betting it is priceless © 2016 Karen Rubin/news-photos-features.com
How much is your child’s life worth? Big Pharma is betting it is priceless © 2016 Karen Rubin/news-photos-features.com

By Karen Rubin, News & Photo Features

How much is it worth to you to save your child’s life? $1 million? $10 million? How much is it worth it to you to have the medication that will prolong your mother’s life from Multiple Myeloma, $10,000 a month? (That’s what the medication cost.)

The issue was most recently dramatized by Mylan, the drug company that has a monopolistic control over the EpiPen syringe, and over the course of but a few years, increased the price for an item that can mean the difference between a child surviving a severe allergic response from $57 to $600 (did I mention it has a year-long shelf life?)

The cost of the actual medication, epinephrine, that can stop potentially fatal anaphylactic shock that’s in the EpiPen dispenser? $1.

It’s not just families who are held up, in much the same way as a gun-wielding robber (“Your money or your life”), but school districts, volunteer fire departments and municipalities who can face a severe budgetary crunch.

And it’s not as if Mylan hasn’t already squeezed the profit out of its drug technology – as rapidly as the price has risen, so have the salaries and bonuses paid to its executives.

The steep increase in prices started when drug company Mylan acquired the rights to the EpiPen nearly a decade ago (the company did not even invest in its development). As they hiked the prices, the salaries of their top executives skyrocketed:  From 2007 to 2015, Mylan CEO Heather Bresch’s total compensation went from $2.5 million to 3,456 to $18,9 million, a mind-blowing 671% increase.

“I am a for-profit business. I am not hiding from that,” Bresch declared. Indeed, Mylan also dodges paying taxes in America, by using the insidious “inversion” loophole.

In other words, Mylan charges more because it can. Its sole aim is to maximize return for management and investors.

About 40 million Americans have severe allergies to spider bites, bee stings and foods like nuts, eggs and shellfish. Last year, more than 3.6 million U.S. prescriptions for two-packs of EpiPens were filled, earning Mylan nearly $1.7 billion.

What was Mylan’s CEO’s response to the outcry?  Mylan said it would expand eligibility for patient assistance, with a $300 savings card.

Mylan is only the latest example. A year ago, the rage was focused on Martin Shkreli, the founder and former chief executive of Turing Pharmaceuticals, who raised the cost of a life-saving drug (which had been available for years from a company he acquired) from an affordable $13.70 a tablet to $750 per tablet.

Another company, Valeant Pharmaceuticals International similarly raised prices of many of its drugs exponentially, including two heart medications, Nitropress and Isuprel used to treat cardiac arrest, and another to treat Wilson’s disease, a rare genetic disorder.

The cynical way they dodge this despicable behavior is to suggest that the consumers don’t actually pay the sticker price – health insurance or Medicare Part D does, or in some cases (as the advertisements like to scream), they offer some relief to the poorest patients. But the upshot is that the rest of us (“society,” if you will) still do pay because of higher premiums. Also, because insurance premiums are so costly, people are opting for cheaper policies that have higher deductibles, so a family might be out-of-pocket to begin with until insurance kicks in.

What is more, the ones who are hurt the most are those who can least afford it: “One of the cruelties of drug pricing is that the burden falls most heavily on those least able to pay it. Uninsured patients often must pay the list price of a drug, and an increasingly large share of insured customers are being asked to pay a percentage of the list price,” writes Katie Thomas in the New York Times. She quotes Pembroke Consulting’s Adam J. Fein, “We soak the poor.”

Not to mention the “donut hole” that many seniors find themselves in. Seniors are finding their costs rising by double digits, 10% in 2015 and 12% in 2014.

There are laws against price-gouging– for food, water, gasoline. There are regulations that keep utility prices – for water, water treatment, electricity – in check, where price hikes have to be justified. Why are there no checks on drug companies, beyond public shaming (which does not seem to work).

The argument is that it costs millions, even a billion dollars and years to research, develop, test and bring a drug to market and many drugs never win approval so never make it to market at all. Well, it also costs millions, even billions, to create a utility system. What is more, taxpayers already pay for a lot of that research, funding programs through universities. (My idea is that taxpayers should be shareholders in the company and get reimbursed through a percentage of the profits on the drug.)

President Obama can use his executive authority to help break Big Pharma’s monopoly power. The FDA controls whether companies can offer alternatives to products like EpiPens, and the National Institutes of Health can prevent new ones from being granted.

Medicare should be allowed to negotiate drug prices (presently inexplicably prohibited under George W. Bush era legislation written by Big Pharma). The Centers for Medicare & Medicaid Services has proposed 6 pilot projects to test possible reforms to how prescription drugs are reimbursed and how the “value” of a drug is measured under Medicare Part B.

Meanwhile, in Congress, Senator Bernie Sanders and Rep. Elijah Cummings of Maryland have introduced bills that would authorize the Secretary of Health and Human Services to negotiate drug prices and reduce barriers to the importation of lower-cost drugs from Canada and other countries.

Another measure being floated in Congress would require a drug company to show justification for any annual price hike greater than 10% (consider that the inflation rate has been running 2%).

But in the absence of Congressional action, California is proposing The California Drug Price Relief Act, which would prohibit the state from paying more for a prescription drug than the lowest price paid for the same drug by Veterans Affairs, which already negotiates lower prices for pharmaceuticals.

“It is no surprise that the pharmaceutical industry already has dedicated $50 million to defeat this ballot initiative,” Sanders said. “Their greed has no end.”

Prices for prescription medicine in the United States soared last year more than 10 percent – the third consecutive year of double digit price increases. One out of five adults between the ages of 18 and 64 – more than 35 million Americans (that’s one out of five)– cannot afford the medications that their doctors prescribe.

Price gouging on life-saving drugs is only one glaring example of why it is an absurdity to operate the health care system as a purely capitalistic, free-market commodity – and yet, this is exactly what is presented by candidates Donald Trump, who vows to repeal Obamacare and the Libertarian Gary Johnson, who thinks that what is wrong with health care system is that there isn’t enough free market forces at work, while Green Party candidate Jill Stein, an actual doctor, has said that the science on childhood vaccinations isn’t definitive.

Hillary Clinton actually has a detailed policy prescription:

Building upon the comprehensive plan she offered earlier in the campaign last year, Clinton is calling for action to protect consumers from unjustified prescription drug price increases by companies that are marketing long-standing, life-saving treatments and face little or no competition. (See: Hillary Clinton Announces Aggressive New Plan to Address Unjustified Price Hikes in Life-Saving Drugs)

 

Clinton would convene representatives of Federal agencies charged with ensuring health and safety and fair competition, and create a dedicated group charged with protecting consumers from outlier price increases. They will determine an unjustified, outlier price increase based on specific criteria including: 1) the trajectory of the price increase; 2) the cost of production; and 3) the relative value to patients, among other factors that give rise to threatening public health.

Should an excessive, outlier price increase be determined for a long-standing treatment, Clinton’s plan would make new enforcement tools available including:

  • Making alternatives available and increasing competition: Directly intervening to make treatments available, and supporting alternative manufacturers that enter the market and increase competition, to bring down prices and spur innovation in new treatments.
  • Emergency importation of safe treatments: Broadening access to safe, high-quality alternatives through emergency importation from developed countries with strong safety standards.
  • Penalties for unjustified price increase to hold drug companies accountable and fund expanded access: Holding drug makers accountable for unjustified price increases with new penalties, such as fines – and using the funds or savings to expand access and competition.

As it is the system is designed to impede research and development into new drug treatments for ailments and diseases that would not have a big enough pay-back (for example, rarer diseases).

The Obama Administration has supported an initiative which focuses on precision medicine – that is, matching appropriate treatments to genetic make up (it’s why certain asthma treatments are less effective for African-Americans and Hispanics than Caucasians), and how certain cancer treatments (such as envisioned in Biden’s Cancer Moonshot) can be much more targeted.

The Health Care Industrial Complex, however, is not designed to prevent or cure, but prolong the stream of profits.

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© 2016 News & Photo Features Syndicate, a division of Workstyles, Inc. All rights reserved. For editorial feature and photo information, go to www.news-photos-features.com, email [email protected]. Blogging at www.dailykos.com/blogs/NewsPhotosFeatures.  ‘Like’ us on facebook.com/NewsPhotoFeatures, Tweet @KarenBRubin