Category Archives: Health Care

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, Womens Issues

First Lady to Lead First-Ever White House Initiative on Women’s Health Research

 The White House Initiative on Women’s Health Research will galvanize the Federal government as well as the private and philanthropic sectors to spur innovation, unleash transformative investment to close research gaps, and improve women’s health. © Karen Rubin/news-photos-features.com

While MAGA Republicans are doing their best to undermine women’s rights, health, ability to succeed, President Biden has announced the first-ever White House initiative on Women’s Health Research, to be led by First Lady Jill Biden and the White House Gender Policy Council. The new initiative will fundamentally change how we approach and fund women’s health research. Presently, most medical research is conducted on men, with serious consequences for health of women across the country. Here is a fact sheet from the White House explaining the new initiative:

Despite making up more than half of the population, women have been understudied and underrepresented in health research for far too long. Research on women’s health is drastically underfunded, leading to significant research gaps, with serious consequences for the health of women across the country. This lack of investment limits our understanding of conditions that are specific to women, predominantly affect women, or affect women differently. In order to give women and their health care providers the tools and information that they need to more effectively prevent, diagnose, and treat these conditions – from rheumatoid arthritis to menopause to Alzheimer’s disease to cardiovascular disease to endometriosis – our nation must fundamentally change how we approach and fund women’s health research.
 
If we act swiftly, we can pioneer the next generation of discoveries in women’s health – improving the lives of millions of women. That’s why, today, President Biden is establishing a new White House Initiative on Women’s Health Research. This new effort will be led by First Lady Jill Biden, who has long championed women’s health, and the White House Gender Policy Council. The Initiative will be chaired by Dr. Carolyn Mazure, an esteemed leader in the field of women’s health research, who will coordinate the Initiative on behalf of the Office of the First Lady and the Gender Policy Council.
 
“I have always believed in the power of research to save lives and to ensure that Americans get the high-quality health care they need,” President Biden stated. “To achieve scientific breakthroughs and strengthen our ability to prevent, detect, and treat diseases, we have to be bold. That’s why today, we’re establishing a new White House Initiative on Women’s Health Research so that my Administration—from the National Institutes of Health to the Department of Defense—does everything we can to drive innovation in women’s health and close research gaps.”
 
“Every woman I know has a story about leaving her doctor’s office with more questions than answers,” commented First Lady Jill Biden. “Not because our doctors are withholding information, but because there’s just not enough research yet on how to best manage and treat even common women’s health conditions. In 2023, that is unacceptable. Our new White House Initiative on Women’s Health Research will help change that by identifying bold solutions to uncover the answers that every woman and her family deserves. We also are calling on congressional leaders, the private sector, research institutions, and philanthropy to join us in taking urgent action to improve the health and lives of women throughout the nation.”
 
PRESIDENTIAL MEMORANDUM ESTABLISHING WHITE HOUSE INITIATIVE ON WOMEN’S HEALTH RESEARCH
 
The White House Initiative on Women’s Health Research will galvanize the Federal government as well as the private and philanthropic sectors to spur innovation, unleash transformative investment to close research gaps, and improve women’s health. As a first step, through today’s Presidential Memorandum, the President is directing his Administration to: 

  • Establish an Initiative consisting of executive departments and agencies across the Federal government. Initiative members include Federal agencies, such as the U.S. Departments of Health and Human Services, Defense, and Veterans Affairs, and White House offices, such as the Office of Management and Budget and the Office of Science and Technology Policy.  
     
  • Deliver concrete recommendations to advance women’s health research. Within 45 days, Initiative members will recommend concrete actions that the Biden-Harris Administration can take to improve how research on women’s health is conducted and maximize the Administration’s investments in women’s health research, including to address health disparities and inequities.
     
  • Take a targeted, high-impact approach. To deliver results quickly, Initiative members will set priority areas of focus where additional investments could be transformative—in areas of research ranging from heart attacks in women to menopause.
     
  • Engage the scientific, private sector, and philanthropic communities. The Initiative will explore new public-private partnerships and engage private and philanthropic leaders to drive innovation and ensure the combined power of public, private, and philanthropic sectors advances research on women’s health.

Dr. Carolyn M. Mazure serves as the Chair of the White House Initiative on Women’s Health Research and has recently joined the Office of the First Lady. Dr. Mazure comes to the White House from the Yale School of Medicine, where she has served as the Norma Weinberg Spungen and Joan Lebson Bildner Professor in Women’s Health Research, and Professor of Psychiatry and Psychology. After three years at the National Institutes of Health and fellowship training at Yale, Dr. Mazure joined the Yale faculty as an active clinician and NIH-funded researcher. She created Women’s Health Research at Yale, the university’s interdisciplinary research center on the health of women, which studies a wide breadth of topics from cardiovascular disease to cancers. She holds a Ph.D. from Pennsylvania State University and did her fellowship and post-doctoral work at Yale School of Medicine.

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

FACT SHEET: White House Cancer Moonshot Announces New Actions, Commitments to End Cancer as We Know It

Today, President Joe Biden and First Lady Jill Biden convened a meeting of the Cancer Cabinet to announce new actions federal agencies are taking to advance the mission of the White House Cancer Moonshot, as well as new commitments the Biden-Harris Administration has secured from non-governmental organizations and the private sector to deliver progress on the mission to end cancer as we know it.
 
Last year, the President and First Lady reignited the Cancer Moonshot with the goals of reducing the cancer death rate in the United States by at least half—preventing more than 4 million cancer deaths—by 2047 and improving the experience of people who are touched by cancer. The President also established a Cancer Cabinet to mobilize the entire Biden-Harris Administration in pursuit of these ambitious goals. In the time since, the Cancer Moonshot has announced roughly 50 new programs, policies, and resources and secured more than 100 commitments from private companies, non-profit organizations, patient groups, and more toward the President’s and First Lady’s goals.
 
Accelerating the fight against cancer is a core component of the President’s Unity Agenda, a set of priorities that Americans from every walk of life can support. In his State of the Union address earlier this year, President Biden laid out a bold vision to advance his Unity Agenda, including the work of the Cancer Moonshot, specifically by driving innovation that changes patient outcomes, providing support to families as they navigate a cancer diagnosis, and preventing cancer by tackling the biggest single driver of cancer deaths in this country—smoking. Today’s actions build on the progress the Cancer Moonshot has delivered since then, and at today’s Cancer Cabinet meeting, the President and First Lady will hear from Cabinet leaders on the progress made and the important work ahead.

“Joe Biden is determined to be a president for all Americans,” White House deputy chief of staff Bruce Reed said in a statement Tuesday. “That is why his Unity Agenda is about making progress on the biggest challenges we all face regardless of party. At his direction, the entire federal government is mobilizing like never before to end cancer as we know it.”

Advanced Research Projects Agency for Health is announcing $240 million in investments to fund research and innovators this year for cancer-related projects, as well as a new partnership with the NIH, the National Cancer Institute to launch a so-called Biomedical Data Fabric Toolbox, which the administration says will be “the first step toward transforming data accessibility across all medical domains.”

In addition, new programs from the US Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Department of Health and Human Services, the Department of Veterans Affairs, and the Environmental Protect Agency will seek to expand cancer care to underserved communities, reduce the impact of smoking in underserved, minority, tribal, and veterans’ communities, and invest in community centers offering cancer screenings.

And NASA, in partnership with the International Space Station, will also announce funding for in-orbit research projects to advance cancer technology.

Biden unveiled his “Cancer Cabinet,” as part of his administration’s broader Cancer Moonshot initiative in 2022. It’s made up of representatives from the Departments of Health and Human Services, Veterans Affairs, Defense, Energy and Agriculture, as well as the Environmental Protection Agency, the National Institutes of Health, the National Cancer Institute and others across the executive branch.

For her part, First Lady Jill Biden has used her platform to support cancer patients and their families, participating in more than 40 Cancer Moonshot events in 16 cities across almost a dozen states, per the White House.

The issue remains a personal one for the Biden family – both have had cancerous lesions removed as part of routine checkups, while their son, Beau Biden, died of a glioblastoma brain tumor in 2015.
 
Today’s announcements from the Biden Cancer Moonshot include:

  • $240 million in additional investment this year to accelerate new ways to prevent, detect, treat, and survive cancer. The Advanced Research Projects Agency for Health (ARPA-H) will award an additional $240 million to researchers and innovators this year for cancer-related projects. This includes projects to develop new tools to detect cancers early, when cancers are most treatable; produce innovative approaches to visualize cancer cells during surgery to improve patient outcomes through the Precision Surgical Interventions program; pursue new treatment approaches, like directing bacteria to kill cancer inside the body; and design devices that could deliver treatments directly to cancer cells to treat tumors more effectively.
     
  • A new “biomedical data fabric toolbox” to advance cancer research progress. ARPA-H is partnering with the National Institutes of Health, the National Cancer Institute (NCI), and other agencies to develop a new Biomedical Data Fabric Toolbox for Cancer. Starting with cancer datasets, this program represents the first step toward transforming data accessibility across all medical domains, promising a future of boundless possibilities in health innovation. Today, cancer research data is collected across thousands of research labs, clinical care organizations, and numerous other sources; these entities all store their datasets differently, making it difficult for cancer researchers to leverage the full potential of massive amounts of data that exist. This initiative will pioneer prototype technologies capable of seamlessly searching cancer datasets to reveal opportunities for groundbreaking disease detection, prevention, and treatment, reduce the time needed to integrate new data sources from months to days, and improve data usability by the research community—so we can break down existing data siloes and learn from the experiences of more patients. This project will help bring America’s cancer research system into the 21st century by transforming our health care system for cancer into a learning system, ensuring that knowledge gained through research is available to as many experts as possible, and delivering discovery and breakthroughs to patients sooner.
     
  • A new nationwide health innovation network to bring cancer clinical trials to underserved communities and drive research progress. ARPA-H is announcing that it’s new ARPANET-H, a nationwide health innovation network to tackle pressing health challenges, will be deployed to accelerate clinical trials for cancer and other diseases. This new network will reach all 50 states and the District of Columbia, and create a continuous feedback loop with patients, providers, researchers, and others that improves the goals, reach, and data sharing capabilities across ARPA-H programs to foster breakthrough collaborations and advance equitable health outcomes. ARPANET-H will comprise Customer Experience, Investor Catalyst, and Stakeholder and Operations hubs, along with a network of supporting spokes that connect local organizations, health providers, companies, and others to ARPA-H’s work. This new network will enable historically underserved populations to actively participate in clinical trials, improve equity in access to innovative cancer interventions and accelerate the agency’s work to drive breakthroughs in preventing, detecting, and treating cancer and other diseases.
     
  • New investments to reduce the impact of menthol and other flavored commercial tobacco products in communities that experience health disparities. The Centers for Disease Control and Prevention is announcing awardees of a new five-year, $15 million program to help increase adoption, implementation, and enforcement of policies prohibiting the sale of menthol and other flavored tobacco products and increase awareness of cessation services and coverage options among populations experiencing tobacco-related disparities in order to accelerate smoking cessation.
     
  • A new award recognizing community health centers for exceptional performance and high clinical quality in cancer screenings. The Health Resources and Services Administration (HRSA) is launching a new National Quality Leader (NQL) – Cancer Screening Badge. Federally qualified community health centers that meet two or more of the Healthy People 2030 breast, cervical, and colorectal cancer screening targets in their annual Uniform Data System performance report will receive the new NQL – Cancer Screening Badge. This badge, which will be awarded annually, was created in support of the Cancer Moonshot’s call to action on cancer screening, and highlights the critical role health centers play in providing historically medically underserved, high-need communities with access to lifesaving cancer screenings. In 2022, community health centers—which provide comprehensive, high-quality primary health care services tailored to their communities regardless of their patients’ ability to pay—served more than 30 million patients nationwide.
     
  • A new plan to decrease the impact of smoking on Americans’ health by expanding efforts to prevent smoking and to support everyone who wants to quit. While the United States has made important progress, smoking remains the biggest single driver of cancer deaths in the country. To ensure Americans who want to quit have the support they need, the Department of Health and Human Services (HHS) will finalize its Framework to Support and Accelerate Smoking Cessation this year. This Framework, which was developed with public input, will be a roadmap for enhancing collaboration and coordination across HHS—and with federal agencies and non-governmental organizations—to equitably accelerate smoking cessation progress, with a specific focus on communities disproportionately impacted by tobacco use.
     
  • New smoking cessation resources for underserved communities, including American Indian, Alaska Native, and Black communities, to reduce cancer health disparities. NCI’s SmokeFree.gov initiative is extending a partnership with the Indian Health Service to collaborate with experts from the University of Minnesota School of Public Health and the American Indian Cancer Foundation to launch SmokeFreeNative, a text messaging program to help American Indian and Alaska Native adolescents and adults quit smoking, while honoring the significance of traditional tobacco. Additionally, NCI is launching digital resources this fall on www.smokefree.gov to encourage and help people who smoke menthol cigarettes to quit. These resources were created to address barriers to quitting in communities that experience disparities caused by menthol cigarette use, with a particular focus on Black communities. 
     
  • A new pilot program to increase veteran engagement in tobacco use treatment. The Department of Veterans Affairs (VA), in collaboration with NCI, will conduct a clinical demonstration project to assess how to more effectively engage veterans in tobacco-use treatment programs. This clinical demonstration project will be implemented in the next year across a subset of Veterans Integrated Services Network clinical resource hubs and aims to address the high rates of tobacco use among veterans with mental health disorders and address gaps in the provision of treatment across facilities.
     
  • New resources and actions to reduce exposures to environmental carcinogens. The Environmental Protection Agency (EPA) is launching epa.gov/cancer, with new information and prominently featured resources from EPA and other federal agencies about secondhand smoke, smoking cessation, and other cancer-related topics. New regulatory efforts, through rules and standards in progress, will regulate unreasonable cancer risks associated with carcinogenic chemicals under statutes including the Toxic Substances Control Act, the Safe Drinking Water Act, and the Clean Air Act. EPA will also continue to leverage its existing authorities under our nation’s bedrock health and environmental laws to accelerate the rate of progress to prevent cancer, including phase-outs of carcinogens, regulatory actions to protect children, workers and overburdened communities, and enforcement actions to ensure pollution is curbed. The Administration’s efforts to fight cancer linked with environmental exposure also advance President Biden’s commitment to environmental justice for all.
     
  • Leveraging research in space to fight cancer on earth and amplifying awareness on cancer screening. NASA’s Division for Biological and Physical Sciences, in partnership with the International Space Station (ISS) National Laboratory, will fund several projects to advance cancer research and technology to take place in-orbit on the ISS. Projects will aim to develop new cancer treatments, broaden research advancements, foster new collaborations, and accelerate biomanufacturing. Additionally, NASA is piloting early cancer screening education videos, partnering with VA to drive targeted education on lung cancer screening for veterans.
     
  • A new partnership to further understanding of the impact cancer has on America’s veterans. In alignment with the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act of 2022, VA and NCI are announcing a new partnership to develop a two-way exchange process to collect more data on cancers in VA patients. This process will allow NCI’s Surveillance, Epidemiology, and End Results (SEER) Program and the VA cancer registry to work together to gain crucial insights on veteran cancer diagnoses and treatments, while maintaining and protecting veteran privacy. Prior to this effort, data exchange was sporadic and incomplete, resulting in a lack of complete information on cancer in this important population. This collaboration will help us better understand—and ultimately treat—cancer among veterans and all Americans.
     
  • An expansion of virtual cancer care for America’s veterans. VA is announcing that it is adding more than 30 new sites to its VA National TeleOncology program, which provides resources and staff support through partnerships with VA medical centers nationwide. This program makes highly specialized care, like virtual tumor boards for multiple cancers, available to veterans, in particular, living in rural locations.

The Cancer Moonshot is also announcing the following new commitments from non-governmental organizations:

  • The American Cancer Society (ACS) will create a new oncology professional navigator curricula and certification program. In 2024, the ACS, with input from key partners, will lead the creation and implementation of a standardized national curricula for professional, non-clinician navigators to support people with cancer. Navigation by trained professionals in clinical settings is an integral component to improving cancer outcomes in the United States, helping to ensure every cancer patient has access to timely, quality, and culturally competent care, especially in historically marginalized communities. Additionally, ACS with will work with key partners to establish new programs such as navigator certification to support evaluation and adherence to best practices that align with improved outcomes.
     
  • The HealthWell Foundation will provide more than $300 million in 2024 to underinsured oncology patients to offset out-of-pocket medication costs. This will enable these patients to adhere to prescribed treatment regimens, and improve survival. In 2024, HealthWell will also start providing financial assistance to address disparities in oncology clinical trials and to support oncology caregivers—self-funding $500,000 for the program. 
     
  • The African American Tobacco Control Leadership Council (AATCLC) is launching a coordinated effort to make Emotional Brain Training (EBT) services available for stress management and smoking cessation. In collaboration with the University of California, San Francisco Smoking Cessation Leadership Center, AATCLC will launch a coordinated effort within three months to promote the use of a free app for anyone new to EBT to gain easily scalable, rapid-acting tools to assist with smoking cessation. EBT has shown long-term effectiveness in treating stress overload, as well as mood and addictive behaviors including smoking.
     
  • CVS Health will be launching an expanded smoking cessation program in a dozen states. In addition to their currently offered smoking cessation and counseling, CVS Health will launch a comprehensive smoking cessation assessment, prescribing and counseling program at its retail pharmacies in 12 states, further increasing patient access to smoking cessation care. Combined with its expanding digital capabilities, CVS Health will be able to reach patients in their neighborhoods, helping address health disparities and breaking down barriers to care, building on their commitment to not sell tobacco products.
     
  • Komodo Health, a health data and technology startup, is announcing a new platform to measure cancer disease burden, map cancer outcomes, and illuminate disparities in cancer care. Over the next two years, this effort will deliver insights to help public health officials, government agencies, and patient advocacy organizations to directly support efforts to close the screening gap and decrease the impact of preventable cancers. Built on more than 330 million patient experiences, Komodo’s platform can be used to spotlight gaps in care, identify disparities in disease burden, and understand the impact of cancer on discrete patient populations. This research will enable public and private partners to direct resources to reduce the burdens of lung cancer.
     
  • The Leukemia & Lymphoma Society (LLS) will invest more than $17 million to bring clinical trials and treatment innovation to diverse and underrepresented communities across the country. For example, LLS is expanding its Influential Medicine Providing Access to Clinical Trials (IMPACT) Research Grant Program to include seven major, geographically diverse cancer centers and surrounding local cancer care delivery settings, to bring blood cancer treatment studies into more communities. As part of the investment, LLS’s Equity in Access Research Program will spend $2.5 million withing the next year to initiate multi-year studies addressing systemic, institutional, clinician, and patient-related barriers to trial participation. In the next five years, LLS aims to improve the speed of innovation and expand equitable access to treatments that have the potential to increase blood cancer patients’ quality of life and survival. 
     
  • TOUCH, the Black Breast Cancer Alliance, will bolster Black women’s breast cancer clinical trial participation by 2025 committing to reaching 350,000 Black women and motivating 25,000 into trial portals. Additionally, TOUCH Care, the first program to provide a nurse navigator service to assist Black breast cancer patients in clinical trials by developing culturally-agile recruiting materials, training trial staff, and coaching patients, is being piloted with Genentech, a member of the Roche Group, and will add five trials annually. Less than three percent of breast cancer clinical trial participants are Black. 
     
  • xCures, a health-data technology platform, is launching a study to enhance the collection and organization of comprehensive data for Diffuse Midline Glioma (DMG) and Diffuse Intrinsic Pontine Glioma (DIPG). The study will streamline and standardize data gathering and identify patterns that can predict disease progression and treatment response, leading to more personalized treatment plans and targeted therapies. xCures pledges to maintain the data infrastructure for this study, and to make the data freely available to academic and government researchers. This will improve access and collaboration, with the ultimate goal of bringing innovation to more patients and providing a better understanding of these deadly cancers.
     
  • The DIPG DMG Research Funding Alliance is launching an online hub to support pediatric brain cancer patients from diagnosis through treatment and grief support. This hub, DIPG OneLink, will provide entry to two complementary data registry studies by the Children Brain Tumor Network and xCures, enrolling 250 DIPG/DMG patients in 2023 and expanding to over 700 patients by the end of 2024. The project will collect, store, and harmonize clinical records, imaging, and multiomics information that will be readily accessible to families and researchers.
     
  • The Focused Ultrasound Foundation (FUSF) is committing more than $3 million over the next three years for clinical trials exploring focused ultrasound as part of cancer treatment. In partnership with the Cancer Research Institute and the Parker Institute for Cancer Immunotherapy, FUSF has defined a roadmap to move towards clinical adoption of focused ultrasound and cancer immunotherapy combination treatments in glioblastoma, diffuse midline glioma, pancreatic cancer, liver cancer, breast cancer, and pediatric solid tumors. In addition, and in partnership with Arms Wide Open, FUSF will co-fund a preclinical research project exploring focused ultrasound for neuroblastoma.   
     
  • The National Brain Tumor Society (NBTS) is launching a comprehensive effort to advance quality of life (QoL) research for people facing brain tumors. NBTS will create a new QoL Research Agenda, the first of its kind in the brain tumor space. This work will foster strong patient, clinician, researcher, and industry partnerships to support future QoL research, and NBTS will formally launch its QoL research funding agenda in early 2024.
     
  • The American Academy of Dermatology (AAD) will launch a national initiative to increase skin cancer awareness and early detection among firefighters. To protect first responders from the impacts of their unique exposure to carcinogenic chemicals, AAD will partner with fire stations and firefighter support organizations to educate them on the importance of early detection. To date, volunteer dermatologists have conducted screenings with over 2,700 local firefighters and volunteers in six states, including California, Massachusetts, Pennsylvania, and Rhode Island, with the program expanding nationwide in 2024.  
     

The National LGBT Cancer Network is making tailored tobacco cessation materials more readily available. LGBTQIA+ communities use commercial tobacco products at rates 49 percent higher than the general population, but there is a dearth of tailored cessation materials for these communities. Building on its community tailored website and a series of social media shareables, the National LGBT Cancer Network is creating at least six LGBTQIA+ tailored, print-based tobacco cessation materials, and will launch a print-on-demand store with all these materials available in the next year. The National LGBT Cancer Network will work with stakeholders like the North American Quitline Consortium, NCI-designated cancer centers, and community members to ensure these materials are compelling and motivational, and widely promote their availability. 

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, Coronavirus Pandemic, Health Care, President Joe Biden

FACT SHEET: Biden Administration Launches Office of Pandemic Preparedness and Response Policy

More than one million Americans died of COVID, millions more are suffering long-COVID; it is estimated that 70 percent died needlessly, avoidably, while Biden’s swift actions to set up a comprehensive vaccination-delivery program (free tests, free masks, free vaccinations), saved 2 million lives. As part of President Biden’s commitment to ensure that our country is more prepared for a pandemic than we were when he took office, the Administration is standing up the Office of Pandemic Preparedness and Response Policy (OPPR). This will be a permanent office in the Executive Office of the President (EOP) charged with leading, coordinating, and implementing actions related to preparedness for, and response to, known and unknown biological threats or pathogens that could lead to a pandemic or to significant public health-related disruptions in the United States. © Karen Rubin/news-photos-features.com

A valid concern Americans should hold is that public health has been so politicized, so weaponized that leaders on all levels of government – federal, state, and local  – who are responsible for the welfare of their constituents, along with the weakening of their ability to take action to protect public health by the radical rightwing extremist judiciary put into place by McConnell and Trump, that we will not be informed when there is a new threat, that they will take action to quarantine, mandate masks and vaccinations to prevent hospital systems from being overwhelmed, and certainly, that concern that there won’t be the resources, the expertise, the means, infrastructure or the fortitude to protect us from the next pandemic. And the next pandemic is certain to take place, not in 100 years, but pushed forward by the changes to the ecosystem because of human-caused climate change.

More than one million died of COVID, millions more are suffering long-COVID; it is estimated that 70 percent died needlessly, avoidably, while Biden’s swift actions to set up a comprehensive vaccination-delivery program (free tests, free masks, free vaccinations), saved 2 million lives. With this in mind, the Biden-Harris Administration is taking steps, setting up the mechanisms to obtain vaccines, treatments and tests – while Florida Governor and presidential wannabe Ron DeSantis has actually made it illegal for Floridians to have a public response to a pandemic and Congressional Republicans show no interest whatsoever in allocating the funds to save lives. (Trump had dismantled the pandemic response infrastructure set up by the Obama Administration. Here is a fact sheet form the White House on its launch of Office of Pandemic Preparedness and Response Policy: –Karen Rubin/news-photos-features.com

The Biden-Harris Administration has made historic progress on our nation’s ability to manage COVID-19 so that it no longer meaningfully disrupts the way we live our lives. Under President Biden’s leadership, the Administration has taken significant steps to ensure all individuals have continued access to lifesaving protections such as vaccines, treatments, and tests, and that the nation is well prepared to manage the risks of COVID-19 or other causes of potential pandemics in the future.
 
As part of the President’s commitment to ensure that our country is more prepared for a pandemic than we were when he took office, the Administration is standing up the Office of Pandemic Preparedness and Response Policy (OPPR). This will be a permanent office in the Executive Office of the President (EOP) charged with leading, coordinating, and implementing actions related to preparedness for, and response to, known and unknown biological threats or pathogens that could lead to a pandemic or to significant public health-related disruptions in the United States. OPPR will take over the duties of the current COVID-19 Response Team and Mpox Team at the White House and will continue to coordinate and develop policies and priorities related to pandemic preparedness and response.
 
To lead this work, the President announced that Major General (ret) Paul Friedrichs will serve as the inaugural Director of OPPR and Principal Advisor on Pandemic Preparedness and Response as of August 7, 2023.  Maj. Gen. (ret) Friedrichs’ unparalleled experience makes him the right person to lead this office. He is currently Special Assistant to the President and Senior Director for Global Health Security and Biodefense at the National Security Council (NSC). Maj. Gen. (ret) Friedrichs previously served as Joint Staff Surgeon at the Pentagon, where he coordinated all issues related to health services, provided medical advice to the Chairman of the Joint Chiefs of Staff and served as medical adviser to the Department of Defense (DoD) Covid-19 Task Force. 
 
The Office of Pandemic Preparedness and Response Policy will:
 
Coordinate the Administration’s domestic response to public health threats that have pandemic potential, or may cause significant disruption, and strengthen domestic pandemic preparedness. This includes ongoing work to address potential public health outbreaks and threats from COVID-19, Mpox, polio, avian and human influenza, and RSV.
 
Drive and coordinate federal science and technology efforts related to pandemic preparedness. Specifically, OPPR will oversee efforts to develop, manufacture, and procure the next generation of medical countermeasures, including leveraging emerging technologies and working with HHS on next generation vaccines and treatments for COVID-19 and other public health threats. During the height of the pandemic, the Biden-Harris Administration made historic investments in COVID-19 vaccines, tests, and treatments that were made widely available. OPPR will continue to leverage these investments as it drives future progress in combatting COVID-19 and other public health threats.
 
Develop and provide periodic reports to Congress. As required by statute, OPPR will develop and provide to Congress a biennial Preparedness Review and Report and Preparedness Outlook Report every five years.
 
Major General (ret) Paul Friedrichs, Inaugural Director of OPPR and Principal Advisor on Pandemic Preparedness and Response
 
Major General Friedrichs is currently Special Assistant to the President and Senior Director for Global Health Security and Biodefense at the National Security Council (NSC). Prior to joining the NSC, Dr. Friedrichs most recently served as the Joint Staff Surgeon and the medical advisor to the Department of Defense (DoD) COVID-19 Task Force. Throughout his career he has worked closely with Federal, State, Tribal, local, and territorial government partners, as well as industry and academic counterparts and has been active in multiple professional medical societies. Dr. Friedrichs has also overseen the DoD global patient evacuation system, supporting global medical care and numerous interagency domestic and global disaster responses. He led the DoD Task Force which developed plans to implement high reliability medical principles across DoD and stood up the Air Force’s first medical analytics capabilities. Over the course of his 37-year career, he has led military hospitals and regional and global health care systems, published multiple medical papers, and consistently sought opportunities to partner with colleagues to improve health care delivery and preparedness. As the United States’ representative to the North Atlantic Treaty Organization Committee of Military Medical Chiefs, he worked closely with many of America’s closest allies and partners throughout the pandemic and in developing medical support to the Ukrainian military.
 
Dr. Friedrichs is a board-certified physician who has cared for hundreds of patients in combat and managed broad domestic and global public health threats. He has spent all of his career in public service, having first received his commission through Reserve Officer Training Corps in 1986 and rising to Major General in 2023.

Biden Administration, Gender Equity, Health Care, News & Photo Features

FACT SHEET: Biden Issues Executive Order on Strengthening Access to Contraception

“My Body My Business.” New Yorkers protest for women’s reproductive freedom © Karen Rubin/news-photos-features.com

On the one-year anniversary since the radical rightwing majority on the Supreme Court overturned women’s constitutional rights to reproductive freedom under Roe v. Wade, President Biden issued an Executive Order on Strengthening Access to Affordable, High-Quality Contraception and Family Planning Services. This was the third Executive Order on reproductive health care access that the President has signed since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, and the first focused specifically on protecting and expanding access to contraception. “Contraception is an essential component of reproductive health care that has only become more important in the wake of Dobbs and the ensuing crisis in women’s access to health care,” the White House stated in a fact sheet detailing the Executive Order.

There is concern that just as the anti-reproductive freedom groups have gone after medication abortion, they may also go after contraception, something that Justice Clarence Thomas suggested he was amenable to do in declaring prior decisions open to “reconsideration.”

Meanwhile, the Federal Drug Administration gave approval for the first over-the-counter sale of a contraceptive pill without a doctor’s prescription. – Karen Rubin/news-photos-features.com

Through today’s Executive Order, the President announced actions to:

  • Improve Contraception Access and Affordability for Women with Private Health Insurance.  The Executive Order directs the Secretaries of the Treasury, Labor, and Health and Human Services (HHS) to consider new guidance to ensure that private health insurance under the Affordable Care Act covers all Food and Drug Administration-approved, -granted, or -cleared contraceptives without cost sharing and to streamline the process for obtaining care women need and want. This action will build on the progress already made under the Affordable Care Act by further reducing barriers that women face in accessing contraception prescribed by their provider.
    • Promote Increased Access to Over-the-Counter Contraception. The Executive Order directs the Secretaries of the Treasury, Labor, and HHS to consider new actions to improve access to affordable over-the-counter contraception, including emergency contraception. These actions could include convening pharmacies, employers, and insurers to discuss opportunities to expand access to affordable over-the-counter-contraception; identifying promising practices regarding the coverage of over-the-counter contraception at no cost to patients; and providing guidance to support seamless coverage of over-the-counter contraception.
       
    • Support Family Planning Services and Supplies through the Medicaid Program. The Executive Order directs the Secretary of HHS to consider new actions that expand access to affordable family planning services and supplies across the Medicaid program—such as sharing best practices for State Medicaid programs on providing high-quality family planning services and supplies, including through Medicaid managed care.
       
    • Improve the Coverage of Contraception through the Medicare Program. To improve coverage and payment for contraceptives for Medicare beneficiaries, the Executive Order directs the Secretary of HHS to consider new actions to strengthen the coverage of contraception through Medicare Advantage and Medicare Part D plans. This action will help ensure that Medicare beneficiaries, especially women of reproductive age with disabilities, can access contraception without unnecessary barriers.
       
    • Support Access to Contraception for Service Members, Veterans, and Federal Employees. The Executive Order directs the Secretary of Defense, the Secretary of Veterans Affairs, and the Director of the Office of Personnel Management to consider new actions to ensure robust coverage of contraception for Service members, veterans, and Federal employees and ensure that they and their families understand how to access these benefits. These actions will build on the steps that these agencies have already taken to bolster access to contraception for those they serve.
       
    • Bolster Contraception Access Across Federally-Supported Health Care Programs. The Executive Order directs the Secretary of HHS to consider encouraging Federally-supported health care and human services entities—such as Title X family planning clinics, community health centers, and the Indian Health Service—to expand the availability and quality of contraception access for those they serve. Actions could include issuing new guidance, technical assistance, and training resources so that providers in these programs understand their obligations under Federal law, including to provide culturally and linguistically appropriate family planning services.
       
    • Support Access to Affordable Contraception for Employees and College Students. The Executive Order directs the Secretary of Labor to identify and share best practices for employers and insurers in making affordable, high-quality contraception available to employees. To help bolster access for college and university students, the Executive Order directs the Secretary of Education to convene institutions of higher education to share best practices and ways to make sure that students understand their options for accessing contraception.
       
    • Promote Research and Data Analysis on Contraception Access.  To document the gaps and disparities in contraception access as well as the benefits of comprehensive coverage, the Executive Order directs the Secretary of HHS to support research, data collection, and data analysis on contraception access and family planning services.

The announcements build on actions that the Biden-Harris Administration has already taken to protect access to contraception, including in response to two prior Executive Orders directing actions to safeguard access to reproductive health care services. The Administration has taken action to:

  • Clarify Protections for Women with Private Health Insurance. Under the Affordable Care Act, most private health plans must provide contraception and family planning counseling with no out-of-pocket costs. The Departments of the Treasury, Labor, and HHS convened a meeting with health insurers and employee benefit plans. These agencies called on the industry to meet their obligations to cover contraception as required under the law. Following this conversation, these agencies issued guidance to clarify protections for contraceptive coverage under the Affordable Care Act.
    • Expand Access Under the Affordable Care Act. The Departments of the Treasury, Labor, and HHS proposed a rule to strengthen access to contraception under the Affordable Care Act so all women who need and want contraception can obtain it. Millions of women have already benefited from this coverage, which has helped them save billions of dollars on contraception.
       
    • Support Title X Clinics. HHS provided resources to bolster quality family planning services through the Title X Family Planning Program. HHS provided funds to help clinics deliver equitable, affordable, client-centered, and high-quality family planning services and provide training and technical assistance for Title X clinics through the Reproductive Health National Training Center and the Clinical Training Center for Sexual and Reproductive Health. In addition, recognizing the important role that Title X clinics play in supporting access to contraception, the President’s Fiscal Year 2024 Budget Request includes $512 million for the Title X Family Planning Program, a 76 percent increase above the 2023 enacted level.
       
    • Enhance Access Through a New Public-Private Partnership. HHS announced a new public-private partnership to expand access to contraception with Upstream, a national nonprofit organization that provides health centers with free patient-centered, evidence-based training and technical assistance to eliminate provider-level barriers to offering the full range of contraceptive options. This partnership will leverage Upstream’s $90 million in resources and build on Upstream’s work with over 100 health care organizations across 18 states and accelerate their national expansion to transform contraceptive care in more than 700 health centers by 2030, reaching 5 million women of reproductive age every year.
       
    • Promote Access to Contraception for Service Members and Their Families and Certain Dependents of Veterans. To improve access to contraception at military hospitals and clinics, the Department of Defense expanded walk-in contraceptive care services for active-duty Service members and other Military Health System beneficiaries. And the Department of Veterans Affairs proposed a rule to eliminate out-of-pocket costs for certain types of contraception through the Civilian Health and Medical Program of the Department of Veterans Affairs.
       
    • Ensure Access to Family Planning Services at Health Centers. The Health Resources and Services Administration provided updated guidance to community health centers on their obligation to offer family planning services to their patients. The guidance included evidence-based recommendations and resources to support health centers in providing high-quality family planning services.
       

Include Family Planning Providers in Health Plan Networks. HHS strengthened the standard for inclusion of family planning providers in Marketplace plans’ provider networks under the Affordable Care Act. This policy, which goes into effect for plan year 2024, will help increase consumers’ choice of high-quality providers and improve access to care for low-income and medically underserved consumers.

Biden Administration, Gender Equity, Health Care, News & Photo Features

FACT SHEET: One Year After SCOTUS Overturned Roe, Biden Administration Highlights Actions to Protect Access to Reproductive Health Care, Ongoing Commitment to Defending Reproductive Rights

New Yorkers protest the Supreme Court’s decision overturning women’s constitutional reproductive rights under Roe v. Wade a year ago © Karen Rubin/news-photos-features.com

On the one-year anniversary since the radical religious ideologues on the Supreme Court overturned Roe v. Wade and women’s constitutional right to self-determination and bodily autonomy, the White House issued this fact sheet highlighting the actions the Biden Administration has taken to protect access to reproductive health care, and its ongoing commitment to defending reproductive rights.

In a statement, President Joe Biden declared,

“One year ago today, the Supreme Court took away a constitutional right from the American people, denying women across the nation the right to choose. Overturning Roe v. Wade, which had been the law of the land for nearly half a century, has already had devastating consequences.
 
“States have imposed extreme and dangerous abortion bans that put the health and lives of women in jeopardy, force women to travel hundreds of miles for care, and threaten to criminalize doctors for providing the health care that their patients need and that they are trained to provide.
 
“Yet, state bans are just the beginning. Congressional Republicans want to ban abortion nationwide, but go beyond that, by taking FDA-approved medication for terminating a pregnancy, off the market, and make it harder to obtain contraception. Their agenda is extreme, dangerous, and out-of-step with the vast majority of Americans.
 
“My Administration will continue to protect access to reproductive health care and call on Congress to restore the protections of Roe v. Wade in federal law once and for all.”

– Karen Rubin/news-photos-features.com

One year ago, the Supreme Court eliminated a constitutional right that it had previously recognized, overturning nearly 50 years of precedent. Today, more than 23 million women of reproductive age—one in three—live in one of the 18 states with an abortion ban currently in effect. In the last year, women have been denied essential medical care to preserve their health and even save their lives. They have been turned away from emergency rooms, forced to delay care, and made to travel hundreds of miles and across state lines for needed medical care. Despite this devastating impact on women’s health, Republican elected officials continue to advance these bans at both the state and national level.

President Biden and Vice President Harris stand with the majority of Americans who believe the right to choose is fundamental—and who have made their voices heard at every opportunity since the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization. As the President has made clear since the day of the Dobbs decision, the only way to ensure women in every state have access to abortion is for Congress to pass a law restoring the protections of Roe v. Wade.

While we continue to call on Congress to restore these protections, the Administration has taken executive action to protect access across the full spectrum of reproductive health care. In the wake of Dobbs, the President issued two Executive Orders directing a comprehensive slate of actions to protect access to reproductive health care services, including abortion. And today, the President is issuing a third Executive Order focused on strengthening access to affordable, high-quality contraception, a critical aspect of reproductive health care. The Administration remains fully committed to implementing these Executive Orders and advancing access to reproductive health care through the leadership of the interagency Task Force on Reproductive Healthcare Access, co-chaired by the White House Gender Policy Council and the Department of Health and Human Services (HHS).

Today, the Biden-Harris Administration is providing an update on the work of the Task Force on Reproductive Healthcare Access and the Administration’s ongoing efforts to defend reproductive rights.

Protecting Access to Abortion, including Medication Abortion

  • Ensure Access to Emergency Medical Care.  The Administration is committed to ensuring all patients, including women who are experiencing pregnancy loss, have access to the full rights and protections for emergency medical care afforded under federal law—including abortion care when that is the stabilizing treatment required. HHS issued guidance affirming requirements under the Emergency Medical Treatment and Labor Act (EMTALA) and Secretary Becerra sentletters to providers making clear that federal law preempts state law restricting access to abortion in emergency situations. The U.S. District Court of Idaho issued a preliminary injunction blocking the enforcement of Idaho’s abortion ban as applied to medical care required by EMTALA after the Department of Justice (DOJ) filed a lawsuit seeking to enjoin Idaho’s ban to the extent it makes abortion a crime even when necessary to prevent serious risks to the health of pregnant patients.
    • Defend FDA Approval of Medication Abortion in Court.  The Food and Drug Administration (FDA) and DOJ are defending access to mifepristone, a safe and effective drug used in medication abortion that FDA first approved more than twenty years ago, and FDA’s independent, expert judgment in court—including in a lawsuit in Texas that attempts to eliminate access nationwide. The Administration will continue to stand by FDA’s decades-old approval of the medication and by FDA’s ability to review, approve, and regulate a wide range of prescription medications.
       
    • Protect Access to Safe and Legal Medication Abortion.  On what would have been the 50th anniversary of Roe v. Wade on January 22, President Biden issued a Presidential Memorandum directing further efforts to protect access to medication abortion, including to support patients, providers, and pharmacies who wish to legally access, prescribe, or provide mifepristone—and to safeguard their safety and security, including at pharmacies. This Presidential Memorandum was issued in the face of attacks by state officials to prevent women from accessing mifepristone and discourage pharmacies from becoming certified to dispense the medication. These attacks followed independent, evidence-based action taken by FDA to allow mifepristone to continue to be prescribed by telehealth and sent by mail as well as to enable interested pharmacies to become certified.
       
    • Partner with State Leaders on the Frontlines of Abortion Access.  Today, the White House is releasing a new report on the battle for abortion access at the state level and the Administration’s engagement with state leaders over the past year. The report underscores the Administration’s ongoing commitment to partnering with leaders on the frontlines of protecting access to abortion—both those fighting extreme state legislation and those advancing proactive policies to protect access to reproductive health care, including for patients who are forced to travel out of state for care. The Vice President has led these efforts, traveling to 18 states and meeting with more than 250 state legislators, health care providers, and advocates in the past year. And last week, the White House hosted over 80 state legislators from 41 states to discuss efforts to protect access to reproductive health care.
    • Provide Access to Reproductive Health Care for Veterans.  The Department of Veterans Affairs (VA) issued an interim final rule to allow VA to provide abortion counseling and, in certain circumstances, abortion care to Veterans and VA beneficiaries. VA provides abortion services when the health or life of the patient would be endangered if the pregnancy were carried to term or when the pregnancy is a result of rape or incest. When working within the scope of their federal employment, VA employees may provide authorized services regardless of state restrictions. DOJ will defend any VA providers whom states attempt to prosecute for violations of state abortion laws. 
       
    • Support Access to Care for Service Members.  The Department of Defense (DoD) has taken action to ensure that Service members and their families can access reproductive health care and that DoD health care providers can operate effectively. DoD has released policies to support Service members and their families’ ability to travel for lawful non-covered reproductive health care and to bolster Service members’ privacy and afford them the time and space needed to make personal health care decisions.
       
    • Defend Reproductive Rights in Court. DOJ created a Reproductive Rights Task Force, which monitors and evaluates state and local actions that threaten to infringe on federal protections relating to the provision or pursuit of reproductive health care, impair women’s ability to seek abortion care where it is legal, impair individuals’ ability to inform and counsel each other about the care that is available in other states, ban medication abortion, or impose criminal or civil liability on federal employees who provide legal reproductive health services in a manner authorized by Federal law.

 
Supporting Women’s Ability to Travel for Medical Care

  • Defend the Right to Travel.  On the day of the Dobbs decisions, President Biden reaffirmed the Attorney General’s statement that women must remain free to travel safely to another state to seek the care they need. President Biden committed his administration to defending “that bedrock right,” and DOJ continues to monitor attempts to restrict a woman’s right to travel to receive lawful health care.  
    • Support Patients Traveling Out of State for Medical Care.  HHS Secretary Becerra and CMS Administrator Chiquita Brooks-LaSure issued a letter to U.S. governors inviting them to work with CMS and apply for Medicaid 1115 waivers to provide increased access to care for women from states where reproductive rights are under attack and women may be denied medical care. HHS continues to encourage state leaders to consider and develop new waiver proposals that would support access to reproductive health care services.
       

Safeguarding Access to Contraception

  • Strengthen Access to Affordable, High-Quality Contraception.  Today, the President issued an Executive Order directing agencies to: improve access and affordability for women with private health insurance; promote increased access to over-the-counter contraception; support access to affordable contraception through Medicaid and Medicare; ensure Service members, veterans, and Federal employees are able to access contraception; bolster contraception access across Federal health programs; and support access for college students and employees. The Task Force on Reproductive Healthcare Access will oversee the swift and robust implementation of this Executive Order in the coming months.
    • Clarify Protections for Women with Private Health Insurance. Under the Affordable Care Act, most private health plans must provide contraception and family planning counseling with no out-of-pocket costs. The Departments of the Treasury, Labor, and HHS convened a meeting with health insurers and employee benefit plans. These agencies called on the industry to meet their obligations to cover contraception as required under the law. Following this conversation, these agencies issued guidance to clarify protections for contraceptive coverage under the Affordable Care Act.
       
    • Expand Access Under the Affordable Care Act.  The Departments of the Treasury, Labor, and HHS proposed a rule to strengthen access to contraception under the Affordable Care Act so all women who need and want contraception can obtain it. Millions of women have already benefited from this coverage, which has helped them save billions of dollars on contraception.
       
    • Support Title X Clinics.  HHS provided resources to bolster quality family planning services through the Title X Family Planning Program, including funding to help clinics deliver equitable, affordable, client-centered, and high-quality family planning services and provide training and technical assistance for Title X clinics. In addition, recognizing the important role that Title X clinics play in supporting access to contraception, the President’s Fiscal Year 2024 Budget Request includes $512 million for the Title X Family Planning Program, a 76 percent increase above the 2023 enacted level.
    • Promote Access to Contraception for Service Members and Their Families and Certain Dependents of Veterans.  To improve access to contraception at military hospitals and clinics, DoD expanded walk-in contraceptive care services for active-duty Service members and other Military Health System beneficiaries, and eliminated TRICARE copays for medical contraceptive services. And VA proposed a rule to eliminate out-of-pocket costs for certain types of contraception through the Civilian Health and Medical Program of the Department of Veterans Affairs.
       

Reinforcing Nondiscrimination Protections under Federal Law

  • Issue Guidance to Retail Pharmacies.  HHS issued guidance to roughly 60,000 U.S. retail pharmacies to remind them of their obligations under federal civil rights laws to ensure access to comprehensive reproductive health care services. The guidance makes clear that as recipients of federal financial assistance, pharmacies are prohibited under law from discriminating on the basis of race, color, national origin, sex, age, and disability in their programs and activities. This guidance is especially important in the wake of reports that women of reproductive age have been denied prescription medication at pharmacies—including medication that is used to treat stomach ulcers, lupus, arthritis, and cancer—due to concerns that these medications could be used to terminate a pregnancy.
    • Protect Students from Discrimination Based on Pregnancy.  The Department of Education (ED) released a resource for universities outlining their responsibilities not to discriminate on the basis of pregnancy or pregnancy-related conditions, including termination of pregnancy. This guidance reminds schools of their existing and long-standing obligations under Title IX.
       
    • Strengthen Nondiscrimination in Healthcare.  HHS announced a proposed rule to strengthen nondiscrimination in health care. The proposed rule implements Section 1557 of the Affordable Care Act and affirms protections consistent with President Biden’s executive orders on nondiscrimination based on sexual orientation and gender identity.
       

Promoting Safety and Security of Patients, Providers, and Clinics

  • Promote Safety and Security of Patients, Providers and Clinics.  DOJ continues to robustly enforce the Freedom of Access to Clinic Entrances Act, which protects the right to access and provide reproductive health services.
     

Safeguarding Privacy and Sensitive Health Information

  • Strengthen Reproductive Health Privacy under HIPAA.  HHS issued a proposed rule to strengthen privacy protections under the Health Insurance Portability and Accountability Act (HIPAA). This rule would prevent an individual’s information from being disclosed to investigate, sue, or prosecute an individual, a health care provider, or a loved one simply because that person sought, obtained, provided, or facilitated legal reproductive health care, including abortion. By safeguarding sensitive information related to reproductive health care, the rule will strengthen patient-provider confidentiality and help health care providers give complete and accurate information to patients. Prior to the proposed rule and immediately after Dobbs, HHS issued guidance reaffirming HIPAA’s existing protections for the privacy of individuals’ protected health information.
    • Take Action Against Illegal Use and Sharing of Sensitive Health Information.  The Federal Trade Commission (FTC) has committed to enforcing the law against illegal use and sharing of highly sensitive data, including information related to reproductive health care. Consistent with this commitment, the FTC has taken first-of-its-kind enforcement actions against companies for disclosing consumers’ personal health information, including highly sensitive reproductive health data, without permission.
    • Help Consumers Protect Their Personal Data.  The Federal Communications Commission (FCC) launched a new guide for consumers on best practices for protecting their personal data, including geolocation data, on mobile phones. The guide follows a recent Notice of Proposed Rulemaking issued by FCC that would strengthen data breach rules to provide greater protections to personal data. In addition, separately, HHS issued a how-to guide for consumers on steps they can take to better protect their data on personal cell phones or tablets and when using mobile health apps, like period trackers, which are generally not protected by HIPAA.
    • Protect Students’ Health Information.  ED issued guidance to over 20,000 school officials to remind them of their obligations to protect student privacy under the Family Educational Rights and Privacy Act (FERPA). The guidance helps ensure that school officials—including those at federally funded school districts, colleges, and universities—know that, with certain exceptions, they must obtain written consent from eligible students or parents before disclosing personally identifiable information from students’ educational records, which may include student health information. The guidance encourages school officials to consider the importance of student privacy, including health privacy, with respect to disclosing student records. ED also issued a know-your-rights resource to help students understand their privacy rights for health records at school. 
    • Safeguard Patients’ Electronic Health Information.  HHS issued guidance affirming that doctors and other medical providers can take steps to protect patients’ electronic health information, including their information related to reproductive health care. HHS makes clear that patients have the right to ask that their electronic health information generally not be disclosed by a physician, hospital, or other health care provider. The guidance also reminds health care providers that HIPAA’s privacy protections apply to patients’ electronic health information.

 
Providing Access to Accurate Information and Legal Resources

  • Ensure Easy Access to Reliable Information.  HHS launched and maintains ReproductiveRights.gov, which provides timely and accurate information on people’s right to access reproductive health care, including contraception, abortion services, and health insurance coverage, as well as how to file a patient privacy or nondiscrimination complaint. DOJ also launched justice.gov/reproductive-rights, a webpage that provides a centralized online resource of the Department’s work to protect access to reproductive health care services under federal law.
    • Hosted a Convening of Lawyers in Defense of Reproductive Rights.  The Department of Justice and the Office of White House Counsel convened more than 200 lawyers and advocates from private firms, bar associations, legal aid organizations, reproductive rights groups, and law schools across the country for the first convening of pro-bono attorneys, as directed in the first Executive Order. Following this convening, reproductive rights organizations launched the Abortion Defense Network to offer abortion-related legal defense services, including legal advice and representation.
       
    • Launch a National Hotline to Enable Access to Accurate Information.  HHS issued a Notice of Funding Opportunity to establish a safe and secure national hotline to provide referral services to women in need of accurate information about their legal reproductive health care options. The nondirective hotline will provide information to patients served by the Title X family planning program who request information related to prenatal care and delivery; infant care, foster care, or adoption; or pregnancy termination.
       

Promote Research and Data Collection

  • Use Data to Track Impacts on Access to Care.  HHS will convene leading experts to discuss the state of existing reproductive health research and what the data tells us about the impact of the Dobbs decision, as well as the future of research on reproductive health care access. These convenings will help identify research gaps, opportunities for collaboration, and ways to bolster research efforts for both Federal agencies and external partners.

Leverage Maternal Health Data to Address Disparities.  FCC has committed to the swift implementation of the Data Mapping to Save Moms’ Lives Act, which directs FCC, in coordination with the Centers for Disease Control and Prevention, to incorporate publicly available data on maternal mortality and morbidity into its Mapping Broadband Health in America platform. This innovation will support women’s health by informing efforts to expand broadband access—including access to telehealth—in areas with poor maternal health outcomes. FCC will continue to explore opportunities to improve research, data collection, data analysis, and interpretation in the context of reproductive health care and maternal health outcomes.

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.
  

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FACT SHEET: Historic Biden Administration Investments in Water Infrastructure, Lead Pipe Replacement Are Creating New Domestic Manufacturing Jobs

Major US manufacturers committing to new investments and hiring in response to historic $50B investment in water infrastructure from President Biden’s Investing in America agenda

 
Senior executives from major U.S.-based manufacturers and distributors of water infrastructure parts joined senior Biden-Harris Administration officials at the White House to announce new private sector investments spurred by President Biden’s Investing in America agenda. The Bipartisan Infrastructure Law includes a more than $50 billion investment in the nation’s water infrastructure – including $15 billion set-aside for lead service line replacement. This historic investment represents a transformational increase in federal investment in the nation’s drinking water infrastructure over the next five years. By requiring Made in-America products when using federal funding to rebuild infrastructure, President Biden is not only investing in fixing our country’s water systems and replacing lead pipes, but also creating good-paying jobs and new domestic manufacturing.
 
To meet the increased demand for American-made water products, American manufacturers are stepping up their production capacity with new investments, creating jobs and American industrial capacity in the process. Administration officials have also emphasized the importance of collaborating with unions to ensure these investments build the middle class from the middle out and bottom up, not top-down.
 
This week, the following firms announced tens of millions in new manufacturing investments and hiring commitments:

  • A.Y. McDonald Mfg. Co. is an Iowa-based 167-year-old 5th generation family business with three manufacturing locations in Iowa, and Tennessee, with plans underway to build a state-of-the-art brass foundry in Wisconsin. Since the beginning of 2019, A.Y. McDonald Mfg. Co. has doubled the manufacturing space of their Tennessee facility with a 100,000 square feet addition and has undertaken the largest capacity expansion in the company’s history having invested millions of dollars in new machinery and automation. Their production workforce has grown 45% since the end of 2020.  In addition, parent company A.Y. McDonald Industries built a 100,000 square foot warehouse to house finished goods and maintenance supplies to free up additional manufacturing space in the 3 existing A.Y. McDonald Mfg. Co. factories.  
     
  • Cerro Flow Products, an Illinois-based pipe manufacturer that is part of the Marmon/Berkshire Hathaway Group – has 100% domestic manufacturing facilities and is currently looking to hire 23 individuals for good-paying union jobs as soon as possible at their Sauget facility. Cerro is also standing ready to add additional shifts at their primary mill, as well as utilize additional manufacturing capabilities at other Cerro sites as demand for water products increases due to federal investments. Cerro has also invested in new workforce development programs, additional upskilling for maintenance and electrical staff, and sponsors a tuition reimbursement program unique to the industry. 
     
  • Commercial Forged Products, an Illinois based company that does not normally make water parts, plans to invest $9 million in additional forging and ancillary equipment, while adding 15 new United Steelworker positions across multiple shifts, as well as hire 4 additional skilled machinists in its Bedford Park facility.
     
  • The Ford Meter Box Company, an Indiana-based company, is expanding its production capacity to meet private and public waterworks infrastructure demand in the long term, as well as lead service line replacement project needs in the near term. Ford has hired 40 new employees already this year, added new shifts, and invested in new equipment, all of which will increase production by 20%.  The construction of a new 300,000 sq. ft. state of the art foundry will be announced this summer, pending final site selection. The new facility, along with committed downstream manufacturing investment, will increase production an additional 42%. This nine-figure manufacturing investment is the largest expansion project in the company’s 125-year history. Additionally, the continued pursuit of a complementary “investment in people” includes a Manufacturing Support Specialist Program, a two-year training program to advance employees into salaried manufacturing, support, and administrative positions.
     
  • Mueller Water Products, an Atlanta-based company, has invested  approximately $150 million in three capital projects in recent years, expanding its U.S. production capacity due in part to the billions of dollars in water infrastructure investments made in the Bipartisan Infrastructure Law. The largest capital project is a new brass foundry located in Decatur, Illinois, which will significantly expand its capacity to produce products, including those commonly used in lead service line replacements. The new foundry, which will replace an existing aging facility, uses a state-of-the-art brass alloy to eliminate dependence on imported Bismuth from China and increases recyclability.  The new foundry – expected to be fully online by 2024 and employ United Steelworkers – and other production improvements are also expected to increase Mueller’s production capacity for brass and other water infrastructure products. Mueller already employs about 465 United Steelworkers in Decatur, and the firm’s investments will help replace 100% of lead service lines and deploy the largest single investment in U.S. water infrastructure.
     
  • Quality Steel Products, a Michigan-based firm that previously did not make components in the water space, has committed to expand its business to meet upcoming demand by adding employees and additional shifts, investing millions of dollars in new forging presses and equipment, induction furnaces, transformers and capital improvement process.

Through historic levels of funding from President Biden’s Bipartisan Infrastructure Law and American Rescue Plan, annual appropriations, and harnessing a variety of tools across federal, state, and local government, the Biden-Harris Administration is delivering tangible progress on the groundbreaking Biden-Harris Lead Pipe and Paint Action Plan to replace all lead service lines in America in the next decade.
 
All Bipartisan Infrastructure Law investments are subject to the Build America, Buy America Act, which requires iron, steel, manufactured products and construction materials used in infrastructure projects to be produced in the United States. President Biden’s Investing in America agenda is revitalizing American manufacturing, including in once hollowed out communities, and creating good-paying jobs across the country. Under President Biden’s manufacturing boom, nearly 800,000 new manufacturing jobs have been created, and private sector companies have announced over $480 billion in manufacturing and clean energy investments since President Biden took office. This week’s announcements provide further evidence his approach to industrial policy is creating good jobs and rebuilding our manufacturing capacity while ensuring every family can access clean, safe drinking water.