Category Archives: Health Care

FACT SHEET: President Biden Issues Executive Order and Announces New Actions to Advance Women’s Health Research and Innovation

President Biden signed a new Executive Order that will direct the most comprehensive set of executive actions ever taken to expand and improve research on women’s health. These directives will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, and will galvanize new research on a wide range of topics, including maternal health © Karen Rubin/news-photos-features.com

In his State of the Union address, President Biden laid out his vision for transforming women’s health research and improving women’s lives all across America. The President called on Congress to make a bold, transformative investment of $12 billion in new funding for women’s health research. This investment would be used to create a Fund for Women’s Health Research at the National Institutes of Health (NIH) to advance a cutting-edge, interdisciplinary research agenda and to establish a new nationwide network of research centers of excellence and innovation in women’s health—which would serve as a national gold standard for women’s health research across the lifespan.

It is long past time to ensure women get the answers they need when it comes to their health—from cardiovascular disease to autoimmune diseases to menopause-related conditions. To pioneer the next generation of discoveries, the President and the First Lady launched the first-ever White House Initiative on Women’s Health Research, which aims to fundamentally change how we approach and fund women’s health research in the United States.

President Biden signed a new Executive Order that will direct the most comprehensive set of executive actions ever taken to expand and improve research on women’s health. These directives will ensure women’s health is integrated and prioritized across the federal research portfolio and budget, and will galvanize new research on a wide range of topics, including women’s midlife health.

The President and First Lady are also announcing more than twenty new actions and commitments by federal agencies, including through the U.S. Department of Health and Human Services (HHS), the Department of Defense (DoD), the Department of Veterans Affairs (VA), and the National Science Foundation (NSF). This includes the launch of a new NIH-wide effort that will direct key investments of $200 million in Fiscal Year 2025 to fund new, interdisciplinary women’s health research—a first step towards the transformative central Fund on Women’s Health that the President has called on Congress to invest in. These actions also build on the First Lady’s announcement last month of the Advanced Research Projects Agency for Health (ARPA-H) Sprint for Women’s Health, which committed $100 million towards transformative research and development in women’s health.

The President is issuing an Executive Order that will:

  • Integrate Women’s Health Across the Federal Research Portfolio. The Executive Order directs the Initiative’s constituent agencies to develop and strengthen research and data standards on women’s health across all relevant research and funding opportunities, with the goal of helping ensure that the Administration is better leveraging every dollar of federal funding for health research to improve women’s health. These actions will build on the NIH’s current policy to ensure that research it funds considers women’s health in the development of study design and in data collection and analysis. Agencies will take action to ensure women’s health is being considered at every step in the research process—from the applications that prospective grantees submit to the way that they report on grant implementation.
     
  • Prioritize Investments in Women’s Health Research. The Executive Order directs the Initiative’s constituent agencies to prioritize funding for women’s health research and encourage innovation in women’s health, including through ARPA-H and multi-agency initiatives such as the Small Business Innovation Research Program and the Small Business Technology Transfer Program. These entities are dedicated to high-impact research and innovation, including through the support of early-stage small businesses and entrepreneurs engaged in research and innovation. The Executive Order further directs HHS and NSF to study ways to leverage artificial intelligence to advance women’s health research. These additional investments—across a wide range of agencies—will support innovation and open new doors to breakthroughs in women’s health.
     
  • Galvanize New Research on Women’s Midlife Health.  To narrow research gaps on diseases and conditions associated with women’s midlife health or that are more likely to occur after menopause, such as rheumatoid arthritis, heart attack, and osteoporosis, the President is directing HHS to: expand data collection efforts related to women’s midlife health; launch a comprehensive research agenda that will guide future investments in menopause-related research; identify ways to improve management of menopause-related issues and the clinical care that women receive; and develop new resources to help women better understand their options for menopause-related symptoms prevention and treatment. The Executive Order also directs the DoD and VA to study and take steps to improve the treatment of, and research related to, menopause for Service women and women veterans.
     
  • Assess Unmet Needs to Support Women’s Health Research. The Executive Order directs the Office of Management and Budget and the Gender Policy Council to lead a robust effort to assess gaps in federal funding for women’s health research and identify changes—whether statutory, regulatory, or budgetary—that are needed to maximally support the broad scope of women’s health research across the federal government. Agencies will also be required to report annually on their investments in women’s health research, as well as progress towards their efforts to improve women’s health.

 
Today, agencies are also announcing new actions they are taking to promote women’s health research, as part of their ongoing efforts through the White House Initiative on Women’s Health Research. Agencies are announcing actions to:

Prioritize and Increase Investments in Women’s Health Research

  • Launch an NIH-Cross Cutting Effort to Transform Women’s Health Throughout the Lifespan. NIH is launching an NIH-wide effort to close gaps in women’s health research across the lifespan. This effort—which will initially be supported by $200 million from NIH beginning in FY 2025—will allow NIH to catalyze interdisciplinary research, particularly on issues that cut across the traditional mandates of the institutes and centers at NIH. It will also allow NIH to launch ambitious, multi-faceted research projects such as research on the impact of perimenopause and menopause on heart health, brain health and bone health. In addition, the President’s FY25 Budget Request would double current funding for the NIH Office of Research on Women’s Health to support new and existing initiatives that emphasize women’s health research.

 
This coordinated, NIH-wide effort will be co-chaired by the NIH Office of the Director, the Office of Research on Women’s Health, and the institute directors from the National Institute on Aging; the National Heart, Lung, and Blood Institute; the National Institute on Drug Abuse; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute on Arthritis, Musculoskeletal and Skin Diseases.
 

  • Invest in Research on a Wide Range of Women’s Health Issues. The bipartisan Congressionally Directed Medical Research Program (CDMRP), led out of DoD, funds research on women’s health encompassing a range of diseases and conditions that affect women uniquely, disproportionately, or differently from men. While the programs and topic areas directed by Congress differ each year, CDMRP has consistently funded research to advance women’s health since its creation in 1993. In Fiscal Year 2022, DoD implemented nearly $490 million in CDMRP investments towards women’s health research projects ranging from breast and ovarian cancer to lupus to orthotics and prosthetics in women.  In Fiscal Year 2023, DoD anticipates implementing approximately $500 million in CDMRP funding for women’s health research, including in endometriosis, rheumatoid arthritis, and chronic fatigue.
     
  • Call for New Proposals on Emerging Women’s Health Issues. Today, NSF is calling for new research and education proposals to advance discoveries and innovations related to women’s health. To promote multidisciplinary solutions to women’s health disparities, NSF invites applications that would improve women’s health through a wide range of disciplines—from computational research to engineering biomechanics. This is the first time that NSF has broadly called for novel and transformative research that is focused entirely on women’s health topics, and proposals will be considered on an ongoing basis.
     
  • Increase Research on How Environmental Factors Affect Women’s Health. The Environmental Protection Agency (EPA) is updating its grant solicitations and contracts to ensure that applicants prioritize, as appropriate, the consideration of women’s exposures and health outcomes. These changes will help ensure that women’s health is better accounted for across EPA’s research portfolio and increase our knowledge of women’s environmental health—from endocrine disruption to toxic exposure.
     
  • Create a Dedicated, One-Stop Shop for NIH Funding Opportunities on Women’s Health. Researchers are often unaware of existing opportunities to apply for federal funding. To help close this gap, NIH is issuing a new Notice of Special Interest that identifies current, open funding opportunities related to women’s health research across a wide range of health conditions and all Institutes, Centers, and Offices. The NIH Office of Research on Women’s Health will build on this new Notice by creating a dedicated one-stop shop on open funding opportunities related to women’s health research. This will make it easier for researchers and institutions to find and apply for funding—instead of having to search across each of NIH’s 27 institutes for funding opportunities.

Foster Innovation and Discovery in Women’s Health

  • Accelerate Transformative Research and Development in Women’s Health. ARPA-H’s Sprint for Women’s Health launched in February 2024 commits $100 million to transformative research and development in women’s health. ARPA-H is soliciting ideas for novel groundbreaking research and development to address women’s health, as well as opportunities to accelerate and scale tools, products, and platforms with the potential for commercialization to improve women’s health outcomes.
     
  • Support Private Sector Innovation Through Additional Federal Investments in Women’s Health Research. The NIH’s competitive Small Business Innovation Research Program and the Small Business Technology Transfer Program is committing to further increasing—by 50 percent—its investments in supporting innovators and early-stage small businesses engaged in research and development on women’s health. These programs will solicit new proposals on promising women’s health innovation and make evidence-based investments that bridge the gap between performance of basic science and commercialization of resulting innovations. This commitment for additional funds builds on the investments the Administration has already made to increase innovation in women’s health through small businesses, including by increasing investments by sevenfold between Fiscal Year 2021 and Fiscal Year 2023.
     
  • Advance Initiatives to Protect and Promote the Health of Women. The Food and Drug Administration (FDA) seeks to advance efforts to help address gaps in research and availability of products for diseases and conditions that primarily impact women, or for which scientific considerations may be different for women, and is committed to research and regulatory initiatives that facilitate the development of safe and effective medical products for women. FDA also plans to issue guidance for industry that relates to the inclusion of women in clinical trials and conduct outreach to stakeholders to discuss opportunities to advance women’s health across the lifespan. And FDA’s Office of Women’s Health will update FDA’s framework for women’s health research and seek to fund research with an emphasis on bridging gaps in knowledge on important women’s health topics, including sex differences and conditions that uniquely or disproportionately impact women.
     
  • Use Biomarkers to Improve the Health of Women Through Early Detection and Treatment of Conditions, such as Endometriosis. NIH will launch a new initiative dedicated to research on biomarker discovery and validation to help improve our ability to prevent, diagnose, and treat conditions that affect women uniquely, including endometriosis. This NIH initiative will accelerate our ability to identify new pathways for diagnosis and treatment by encouraging multi-sector collaboration and synergistic research that will speed the transfer of knowledge from bench to bedside.
     
  • Leverage Engineering Research to Improve Women’s Health. The NSF Engineering Research Visioning Alliance (ERVA) is convening national experts to identify high-impact research opportunities in engineering that can improve women’s health. ERVA’s Transforming Women’s Health Outcomes Through Engineering visioning event will be held in June 2024, and will bring together experts from across engineering—including those in microfluidics, computational modeling, artificial intelligence/imaging, and diagnostic technologies and devices—to evaluate the landscape for new applications in women’s health. Following this event, ERVA will issue a report and roadmap on critical areas where engineering research can impact women’s health across the lifespan.
     
  • Drive Engineering Innovations in Women’s Health Discovery. NSF awardees at Texas A&M University will hold a conference in summer 2024 to collectively identify challenges and opportunities in improving women’s health through engineering. Biomedical engineers and scientists will explore and identify how various types of engineering tools, including biomechanics and immuno-engineering, can be applied to women’s health and spark promising new research directions.

Expand and Leverage Data Collection and Analysis Related to Women’s Health

  • Help Standardize Data to Support Research on Women’s Health. NIH is launching an effort to identify and develop new common data elements related to women’s health that will help researchers share and combine datasets, promote interoperability, and improve the accuracy of datasets when it comes to women’s health. NIH will initiate this process by convening data and scientific experts across the federal government to solicit feedback on the need to develop new NIH-endorsed common data elements—which are widely used in both research and clinical settings. By advancing new tools to capture more data about women’s health, NIH will give researchers and clinicians the tools they need to enable more meaningful data collection, analysis, and reporting and comprehensively improve our knowledge of women’s health.
     
  • Reflect Women’s Health Needs in National Coverage Determinations. The Centers for Medicare & Medicaid Services (CMS) will strengthen its review process, including through Coverage with Evidence Development guidance, to ensure that new medical services and technologies work well in women, as applicable, before being covered nationally through the Medicare program. This will help ensure that Medicare funds are used for treatments with a sufficient evidence base to show that they actually work in women, who make up more than half of the Medicare population.
     
  • Leverage Data and Quality Measures to Advance Women’s Health Research. The Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) are building on existing datasets to improve the collection, analysis, and reporting of information on women’s health. The CDC is expanding the collection of key quality measures across a woman’s lifespan, including to understand the link between pregnancy and post-partum hypertension and heart disease, and plans to release the Million Hearts Hypertension in Pregnancy Change Package. This resource will feature a menu of evidence-informed strategies by which clinicians can change care processes. Each strategy includes tested tools and resources to support related clinical quality improvement. HRSA is modernizing its Uniform Data System in ways that will improve the ability to assess how women are being served through HRSA-funded health centers. By improving the ability to analyze data on key clinical quality measures, CDC and HRSA can help close gaps in women’s health care access and identify new opportunities for high-impact research.  

Strengthen Coordination, Infrastructure, and Training to Support Women’s Health Research

  • Launch New Joint Collaborative to Improve Women’s Health Research for Service Members and Veterans. DoD and VA are launching a new Women’s Health Research collaborative to explore opportunities that further promote joint efforts to advance women’s health research and improve evidence-based care for Service members and veterans. The collaborative will increase coordination with the goal of helping improve care across the lifespan for women in the military and women veterans. The Departments will further advance research on key women’s health issues and develop a roadmap to close pressing research gaps, including those specifically affecting Service women and women veterans.
     
  • Coordinate Research to Advance the Health of Women in the Military. DoD will invest $10 million, contingent on available funds, in the Military Women’s Health Research Partnership. This Partnership is led by the Uniformed Services University and advances and coordinates women’s health research across the Department. The Partnership is supporting research in a wide range of health issues affecting women in the military, including cancers, mental and behavioral health, and the unique health care needs of Active Duty Service Women. In addition, the Uniformed Services University established a dedicated Director of Military Women’s Health Research Program, a role that is responsible for identifying research gaps, fostering collaboration, and coordinating and aligning a unified approach to address the evolving needs of Active Duty Service Women.
     
  • Support EPA-Wide Research and Dissemination of Data on Women’s Health. EPA is establishing a Women’s Health Community of Practice to coordinate research and data dissemination. EPA also plans to direct the Board of Scientific Counselors to identify ways to advance EPA’s research with specific consideration of the intersection of environmental factors and women’s health, including maternal health.
     
  • Expand Fellowship Training in Women’s Health Research. CDC, in collaboration with the CDC Foundation and American Board of Obstetrics and Gynecology, is expanding training in women’s health research and public health surveillance to OBGYNs, nurses and advanced practice nurses. Through fellowships and public health experiences with CDC, these clinicians will gain public health research skills to improve the health of women and children exposed to or affected by infectious diseases, mental health and substance use disorders. CDC will invite early career clinicians to train in public health and policy to become future leaders in women’s health research.

Improve Women’s Health Across the Lifespan

  • Create a Comprehensive Research Agenda on Menopause. To help women get the answers they need about menopause, NIH will launch its first-ever Pathways to Prevention series on menopause and the treatment of menopausal symptoms. Pathways to Prevention is an independent, evidence-based process to synthesize the current state of the evidence, identify gaps in existing research, and develop a roadmap that can be used to help guide the field forward. The report, once completed, will help guide innovation and investments in menopause-related research and care across the federal government and research community.
     
  • Improve Primary Care and Preventive Services for Women. The Agency for Healthcare Research and Quality (AHRQ) will issue a Notice of Intent to publish a funding opportunity announcement for research to advance the science of primary care, which will include a focus on women’s health. Through this funding opportunity, AHRQ will build evidence about key elements of primary care that influence patient outcomes and advance health equity—focusing on women of color—such as care coordination, continuity of care, comprehensiveness of care, person-centered care, and trust. The results from the funding opportunity will shed light on vital targets for improvements in the delivery of primary healthcare across a woman’s lifespan, including women’s health preventive services, prevention and management of multiple chronic diseases, perinatal care, transition from pediatric to adult care, sexual and reproductive health, and care of older adults.
     
  • Promote the Health of American Indian and Alaska Native Women. The Indian Health Service is launching a series of engagements, including focus groups, to better understand tribal beliefs related to menopause in American Indian and Alaska Native Women. This series will inform new opportunities to expand culturally informed patient care and research as well as the development of new resources and educational materials.
     
  • Connect Research to Real-World Outcomes to Improve Women’s Mental and Behavioral Health. The Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a range of health care providers to address the unique needs of women with or at risk for mental health and substance use disorders. Building on its current efforts to provide technical assistance through various initiatives, SAMHSA intends, contingent on available funds, to launch a new comprehensive Women’s Behavioral Health Technical Assistance Center. This center will identify and improve the implementation of best practices in women’s behavioral health across the life span; identify and fill critical gaps in knowledge of and resources for women’s behavioral health; and provide learning opportunities, training, and technical assistance for healthcare providers.
     
  • Support Research on Maternal Health Outcomes. USDA will fund research to help recognize early warning signs of maternal morbidity and mortality in recipients of Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and anticipates awarding up to $5 million in Fiscal Year 2023 to support maternal health research through WIC. In addition, research being conducted through the Agricultural Research Service’s Human Nutrition Research Centers is focusing on women’s health across the lifespan, including the nutritional needs of pregnant and breastfeeding women and older adults.

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

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

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

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

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

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

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

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

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

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

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

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

Honoring America’s Commitment to Seniors

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

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

Strong Record on Expanding and Strengthening Health Care Nationwide

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

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

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

FACT SHEET: Marking 51st Anniversary of Roe v. Wade, White House Task Force on Reproductive Healthcare Access Announces New Actions; Biden, Harris Vow to Restore Rights

Women’s March on Washington, Jan. 21, 2017. The contrast couldn’t be more stark: Women march in record numbers in Washington the day after Trump’s inauguration; Trump now boasts how he is responsible for the Supreme Court overturning women’s reproductive rights. The majority of Americans want reproductive freedom. Today, on what would have been the 51st anniversary of Roe, President Biden and Vice President Harris affirmed their commitment to restore women’s rights, bodily autonomy and self-determination. © Karen Rubin/news-photos-features.com

Biden-Harris Administration Announces New Actions to Help Strengthen Access to Contraception, Protect Access to Medication Abortion, and Ensure Patients Receive Emergency Medical Care

Today, on what would have been the 51st anniversary of Roe v. Wade, women’s health and lives hang in the balance due to extreme state abortion bans. These dangerous state laws have caused chaos and confusion, as women are being turned away from emergency rooms, forced to travel hundreds of miles, or required to go to court to seek permission for the health care they need.  

In the face of the continued threats to reproductive freedom, President Biden convened the fourth meeting of the Task Force on Reproductive Healthcare Access, where agencies announced new actions to protect access to reproductive health care. The Task Force also heard directly from physicians who are on the frontlines of the fallout from the overturning of Roe v. Wade.  

Opening the meeting, President Biden declared:  

Fifty-one years ago today, in Roe v. Wade, the Supreme Court recognized a woman’s constitutional right to choose — constitutional right to choose — the right to make a deeply personal decision with her doctor, free from the interference of politicians. I believe Roe v. Wade was right.  But then, a year and a half ago, this Supreme Court made an extreme decision, overturning Roe with their Dobbs decision, to rip away a constitutional right from the American people, which had never been done before — a fundamental right ripped away — important to so many Americans, a right that is vital to a country founded on the idea of freedom.  
 
I said on that day that Roe was overturned, the health and lives of women in this nation would now be at risk.  And that has unfortunately proven to be true…Today, in 2024 in America, women are turned away from emergency rooms, forced to travel hundreds of miles to get basic healthcare in another state that may have a different rule, forced to go to court to plead for help… 
 
The cruelty is astounding — an affront to a woman’s dignity, being told by extreme politicians to wait, to get sicker and sicker to the point where her life may be in danger before you can get the care you need. That cruel reality is the result of extreme Republicans who, for years, have made it their mission to end the Roe v. Wade decision. 
 
Since Roe was overturned, in 21 states, abortion bans are now in effect, many with no exception for rape or incest. We have doctors with us today who are on the frontlines of this crisis.  And they can attest to the consequences that these extreme laws are having on doctors and on their ability to care for their patients. Some doctors are fleeing their home states because of laws that would send them to prison for providing evidence-based healthcare. In states like Texas, doctors can get a life sentence — a life sentence for providing the care they were trained to provide.  It’s outrageous.  It’s simply outrageous.
 
And, frankly, this is just the beginning. My congressional Republican friends are going to even further extremes to undermine a woman’s rights and threatening the lives of women. Three different Republican members in the United States Congress have proposed three different additional national bans to criminalize healthcare in every state.  Let me tell you what they are.
 
One is a zero-week ban with absolutely no exceptions — a zero-week with absolutely no exceptions.  The second is a six-week ban.  The penalty for violating it is jail.  The third is a 15-week ban.  The penalty is a five-year prison sentence.
 
That means even if you live in a state where the extremist Republicans are not running the show, your right to choose, your right to privacy would still be at risk if this law was passed — any of these were passed nationally.
 
And the extreme right is trying to limit all women in America from getting a safe and effective medication, approved by the Federal Drug Administration over 20 years ago based on the FDA’s independent expert judgment.  They’re trying to block women from getting this medication even in states where abortion is legal. 
 
And on top of all of that, if you live in a state where you cannot get this care you need and you make a plan to travel to a state where you can get the[medical care],[Republican officials] are trying to stop that as well. In Alabama the Attorney General is threatening to prosecute people who help family members travel to another state.
 
Folks, this is what it looks like when the right to privacy is under attack.  These extreme laws have no place in the United States of America. 
 
You know, the American people know these laws are wrong.  The vast majority of Americans believe the right to choose is fundamental. 
 
Also today, the Vice President launch her nationwide Fight for Reproductive Freedoms tour to continue fighting back against extreme attacks throughout America. “These extremists want to roll back the clock to a time before women were treated as full citizens,” she declared at the kick-off event in Waukesha County, Wisconsin, 51 years to the day that Roe v. Wade was decided.

“As we face this crisis, as we are clear eyed about the harm, let us also understand who is responsible, shall we? The former president hand picked three Supreme Court justices because they intended for them to overturn Roe. .. Proud? Proud? Proud that women across our nation are suffering? Proud that women have been robbed of a fundamental freedom? Proud that doctors could be thrown in prison for caring for their patients, that young people today have fewer rights than their mothers and their grandmothers? How dare he?” the Vice President declared.

Biden-Harris Administration Actions to Protect Reproductive Health Care
 
During the Task Force meeting, members reported on ongoing implementation of the President’s three Executive Orders and a Presidential Memorandum on access to reproductive health care and announce new steps to: 

  • Strengthen Contraception Access and Affordability for Women with Private Health Insurance. The Administration is committed to ensuring that women have access to contraception—an essential component of reproductive health care that has only become more important in the wake of the Supreme Court’s decision to overturn Roe v. Wade—and reducing barriers that women face in accessing contraception prescribed by their provider. The Departments of the Treasury, Labor, and Health and Human Services (HHS) are issuing new guidance to clarify standards and support expanded coverage of a broader range of FDA-approved contraceptives at no cost under the Affordable Care Act. This action builds on the progress already made by the Affordable Care Act to expand access to affordable contraception for millions of women nationwide.

    In addition, the Office of Personnel Management will strengthen access to contraception for federal workers, retirees, and family members by issuing guidance to insurers participating in the Federal Employee Health Benefits Program that incorporates the Departments’ guidance. OPM will also newly require insurers that participate in the Federal Employee Health Benefits Program to take additional steps to educate enrollees about their contraception benefits.
    • Reinforce Obligations to Cover Affordable Contraception. The Secretary of HHS is issuing a letter to private health insurers, state Medicaid and Children’s Health Insurance Programs, and Medicare plans about their obligations to cover contraception for those they serve. The letter targets a wide range of payers to advance compliance with existing standards and underscore the Administration’s commitment to ensuring that women across the country can access affordable contraception. The letter also highlights recent HHS action to expand coverage and improve payment for contraceptives for Medicare beneficiaries, improving access for women with disabilities.
       Educate Patients and Health Care Providers on Their Rights and Obligations for Emergency Medical Care. The Administration is committed to helping ensure all patients, including women who are experiencing pregnancy loss and other pregnancy-related emergencies, have access to emergency medical care required under the Emergency Medical Treatment and Labor Act (EMTALA). The Administration has long taken the position that the required emergency care can, in some circumstances, include abortion care. The Department of Justice (DOJ) is defending that interpretation of the law before the Supreme Court, which is expected to rule by June. 

      To increase awareness of EMTALA and improve the procedures for ensuring that patients facing all types of medical emergencies receive the care to which they are entitled, HHS is announcing today a comprehensive plan to educate all patients about their rights and to help ensure hospitals meet their obligations under federal law. This effort will include the launch of new accessible and understandable resources about rights and protections for patients under EMTALA and the process for submitting a complaint. HHS will also disseminate training materials for health care providers and establish a dedicated team of experts who will increase the Department’s capacity to support hospitals and providers across the country in complying with federal requirements—to help ensure that every patient receives the emergency medical care required under federal law.
       
  • Protect Access to Safe and Legal Medication Abortion. One year ago today, President Biden issued a Presidential Memorandum directing further efforts to support patients, providers, and pharmacies who wish to legally access, prescribe, or provide medication abortion—including by taking steps to safeguard their safety and security. Today, the Department of Health and Human Services, the Department of Justice, and the Department of Homeland Security will report on their implementation of this Presidential Memorandum, including the resources they have disseminated to health care providers, including pharmacies, to support safe access to legal medication abortion.

 Today’s announcements build on the Administration’s strong record of taking action since the Supreme Court’s decision to overturn Roe v. Wade. These ongoing efforts to defend reproductive rights include:
 
Protecting Access to Abortion, including Medication Abortion

  • 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 before the Supreme Court that attempts to curtail access nationwide. The Administration will continue to stand by FDA’s decades-old approval and regulation of the medication and by FDA’s ability to review, approve, and regulate a wide range of prescription medications. Efforts to impose outdated restrictions on mifepristone would limit access to reproductive health care in every state in the country.
    • Protect Access to Safe and Legal Medication Abortion.  On what would have been the 50th anniversary of Roe v. Wade, President Biden issued a Presidential Memorandum directing agencies to consider further efforts to protect access to medication abortion. 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.  The White House continues to partner 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 20 states and meeting with more than 250 state legislators, health care providers, and advocates in the past year. Today, she is kicking off her nationwide Fight for Reproductive Freedoms tour in Wisconsin.
       
    • Ensure Access to Emergency Medical Care.  Republican elected officials in states across the country have put women’s lives at risk by banning abortion even when her doctor determines that an abortion is necessary to prevent serious health consequences. The Administration is committed to ensuring all patients, including women who are experiencing pregnancy loss and other pregnancy-related emergencies, 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 and Secretary Becerra sent letters to providers affirming the Administration’s view that EMTALA preempts conflicting state law restricting access to abortion in emergency situations. The Department of Justice has taken action defend and enforce these protections in court, including in a case currently before the Supreme Court.
       
    • 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 abortion services as authorized by federal law regardless of state restrictions. DOJ will support and provide representation to any VA providers whom states attempt to prosecute for violations of state abortion laws where those providers were appropriately carrying out their duties under VA’s interim final rule. 
       
    • 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 mifepristone based on disagreement with FDA’s expert judgment about its safety and efficacy, 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 Supreme Court’s decision to overturn Roe v. Wade, 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. In November 2023, DOJ filed a statement of interest in two lawsuits challenging the Alabama Attorney General’s threat to prosecute people who provide assistance to women seeking lawful out-of-state abortions. DOJ explained that the threatened Alabama prosecutions infringe the constitutional right to travel and made clear that states may not punish third parties for assisting women in exercising that right. DOJ continues to monitor states’ efforts to restrict the constitutional right to travel across state lines to receive lawful health care.  
    • Support Patients Traveling Out of State for Medical Care.  HHS issued a letter to U.S. governors inviting them to apply for Section 1115 waivers to expand access to care under the Medicaid program for women traveling from a state 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.  Ahead of the one-year anniversary of the Supreme Court’s decision to overturn Roe v. Wade, the President issued an Executive Order directing agencies to consider actions 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. These are just some of the recent actions taken by the Biden-Harris Administration to implement this Executive Order:
    • Following FDA’s approval of the first daily oral contraceptive in the United States without a prescription, the Departments of the Treasury, Labor, and HHS issued a Request for Information to solicit public input on how to best ensure coverage and access to over-the-counter preventive services, including contraception, at no cost and without a prescription from a health care provider.
    • Vice President Harris and the Department of Education convened representatives from 68 college and university leaders in 32 states to hear promising strategies from leaders of postsecondary institutions for protecting and expanding access to contraception for their students and on campus.
    • The Gender Policy Council, Domestic Policy Council, and leaders from the Departments of the Treasury, Labor, and HHS convened private sector leaders to stress the need to continue to build on the significant progress already made under the Affordable Care Act in expanding access to contraception and call on participants to take robust additional actions to improve access.
    • The Health Resources and Services Administration proposed new data measures for federally funded health centers that, once finalized, will help ensure that patients are screened for contraception needs. Screening and data measures will help enhance the overall delivery of voluntary family planning and related services, which is a required primary health care service under federal law.
    • The Office of Personnel Management launched a public education campaign to highlight contraception benefits available to federal employees and their family members.
    • HHS is continuing its 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. To date, HHS has connected Upstream to nearly 100 health care clinics, resulting in partnerships that will help Upstream accelerate their national expansion to reach 5 million women of reproductive age every year. 
    • Clarify Protections for Women with Private Health Insurance. Under the Affordable Care Act, most private health plans must provide coverage for 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 with private health coverage who need and want contraception can obtain it without cost sharing. Millions of women have already benefited from this coverage, which has helped them save billions of dollars on contraception.
       
    • Support Title X Clinics.  Last year, HHS provided $263 million to over 4,000 Title X clinics across the country to provide a wide range of voluntary, client-centered family planning and related preventive services. The Title X Family Planning Program remains a critical part of the nation’s safety net, providing free or low-cost services for 2.6 million clients in 2022.
       
    • 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 certain 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.

 
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). As proposed, 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 ruleHHS 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 several 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 Notice of Proposed Rulemaking issued by FCC that would strengthen data breach rules to provide greater protections to personal data. 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—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.

 
Reinforcing Nondiscrimination Protections under Federal Law

  • Protect Students from Discrimination Based on Pregnancy.  The Department of Education (ED) released a resource for universities reiterating 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 issued a proposed rule to strengthen nondiscrimination in health care. The proposed rule would implement 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.

 
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 on the Department’s ongoing work to protect access to reproductive health care services under federal law.
    • Hosted a Convening of Lawyers in Defense of Reproductive Rights.  DOJ 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 a 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.

 
Promote Research and Data Collection

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

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

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

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

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

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

The Biden-Harris Administration announced:

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

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

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

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

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

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

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

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

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


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

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

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

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

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

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

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

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 homeshospiceshome careautism 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 chargesCMS 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.

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-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.

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 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.

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.