Insurance and Health – International World Of Business

Patients Will Bear the Cost of U.S. Government Price Controls

Press Room Team — Thu, 08 Feb 2024 21:29:02 +0000

Up to 44% fewer medicines will be launched in the United States because of government price controls, according to the 2024 Patient Access Report.

Today, patients in the United States have greater access to the latest lifesaving and life-altering medical treatments than anywhere else. However, the nation’s ability to access the latest healthcare innovations in the future is uncertain.

Behind the scenes, unelected bureaucrats in Washington are pushing for greater control over the medicines Americans can access by imposing unprecedented price controls.

These changes threaten access to the vital lifesaving treatments patients need today and the breakthrough discoveries that you or a loved one suffering from a debilitating disease might count on tomorrow.

Historic Data Uncovers Alarming Impact of Price Controls

Less access and delayed care: In 2023, the first edition of the U.S. Chamber’s Patient Access Report revealed how foreign governments who impose similar price controls caused reduced access to new medicines and longer treatment wait times, sometimes exceeding 500 days. Sometimes, patients with severe conditions had to wait over 16 months for treatment.
‘Research deserts’ for medicine: Another study shows how the government’s price controls pose a severe threat to the U.S. clinical trial research vital to discovering new treatments for diseases like cancer, Alzheimer’s, obesity, and heart disease. Data suggests a potential 75% cut in some areas of privately funded medical and clinical research funding.

New Findings Expose Growing Threats for American Patients

In 2024, the second edition of the Patient Access Report paints a grim scenario where new medicines become scarce, and patients endure long wait times with limited options—an outcome no one should support.

U.S. medicine launches may drop by 44%: Due to the government’s price controls, the United States faces a potential 29% to 44% drop in new medicines. Other research from Vital Transformation suggests a 40% drop in FDA approvals over a decade, and a University of Chicago study estimated an 18.5% reduction in U.S. life sciences research and development spending.
The U.S. has benefited from a decade of leadership in medical innovation and access: From 2012 to 2021, 85% of new medicines entered the American market. The U.S. led in accessing new medicines, measured by an objective tool called the Patient Access Matrix, akin to a report card for therapy access. Germany, the closest competitor, had only 61% introduced locally. Meanwhile, countries like Canada, Spain, Australia, and South Korea fell further behind, with less than half of the new medicines available.
Price controls shift the U.S. from leader to middle of the pack: However, things will change due to new price controls and potential property seizures via march-in rights. The analysis now projects that the U.S. ranking will decline to reflect those of countries like the European Union member states, Australia, and Canada, known for extended patient wait times.

Bottom Line

Patients and innovators alike should be alarmed about the impact of the government’s march for price controls. In the face of these challenges, the future of access to vital treatments in the United States is uncertain. We must act now to protect patients’ access to lifesaving medicines and support continued medical progress.

To learn more, use the button at the top of the page to download the full report.

FDIC demands entities cease false deposit insurance claims

Press Room Team — Tue, 23 Jan 2024 13:07:27 +0000

WASHINGTON, D.C. January 22, 2024.- The Federal Deposit Insurance Corporation (FDIC) today issued letters demanding five entities and certain associated parties cease and desist from making false and misleading statements about FDIC deposit insurance. The FDIC is demanding that Atmos Financial, PBC (Atmos); BybitcoinEx, Inc. (BybitcoinEx); ORGANO Payments, Inc. and its subsidiary OGPay (OGPay); Horizon Globex GmbH (Horizon), which operates Upstream Exchange; and Zil Money Corporation (Zil) take immediate corrective action to address these false or misleading statements.

Based upon evidence collected by the FDIC, the companies and certain associated parties made false representations by: (1) stating or suggesting that these entities are FDIC-insured or that certain uninsured financial products are insured by the FDIC; (2) misusing the FDIC name or logo; (3) misrepresenting the nature or extent of deposit insurance; and/or (4) failing to clearly identify the insured depository institutions with which they have a relationship for the placement of customer deposits and into which funds may be deposited. These material misrepresentations and omissions are false and misleading, and have the potential to harm consumers.

“Combatting misrepresentations about deposit insurance coverage goes to the heart of the FDIC’s mission of maintaining stability and public confidence in the nation’s banking system,” said FDIC Chairman Martin J. Gruenberg. “These practices can not only confuse and harm those who are targeted with the false promise of deposit insurance, but, if left unchecked, could also undermine confidence in the FDIC, FDIC–insured banks, and the U.S. banking system.”

The Federal Deposit Insurance Act (FDI Act) prohibits any person from representing or implying that an uninsured financial product is FDIC–insured or from knowingly misrepresenting the extent and manner of deposit insurance. The FDI Act further prohibits companies from implying that they are FDIC-insured or their products are FDIC–insured by using “FDIC” in the company’s name, advertisements, or other documents. The FDIC is authorized by the FDI Act to enforce this prohibition against any person.

On December 20, 2023, the FDIC Board of Directors adopted a final rule to amend part 328 of its regulations, which updates the FDIC’s regulations regarding false advertising, misrepresentations of deposit insurance coverage, and misuse of the FDIC’s name and logo. For example, the final rule clarifies that FDIC–associated terms or images may not be used in marketing and advertising materials to inaccurately imply or represent that any uninsured financial product or non–bank entity is insured or guaranteed by the FDIC.

FDIC deposit insurance protects customers in the unlikely event of the failure of an insured depository institution. To determine if an institution is FDIC–insured, you can ask a representative of the institution, look for the FDIC sign at the institution, or use the FDIC’s BankFind tool. For general information about FDIC deposit insurance, read the following frequently asked questions. For more information about FDIC insurance and digital asset companies, read the following fact sheet.

OIR Approves an 15.1% Decrease in Workers’ Compensation Insurance Rates for 2024

Press Room Team — Tue, 14 Nov 2023 16:49:41 +0000

TALLAHASSEE, Fla. November 13, 2023.- Florida Insurance Commissioner Michael Yaworsky issued a Final Order granting approval to the National Council on Compensation Insurance (NCCI) for a statewide overall workers’ compensation insurance rate decrease of 15.1 percent. The rate decrease applies to both new and renewal workers’ compensation insurance policies effective in Florida as of January 1, 2024.

“As a former small business owner myself, I’m always working to support Florida’s small businesses and entrepreneurs. A decrease in workers’ compensation rates means lower insurance costs for employers, allowing them to put more money back into their business, where it belongs,” said Chief Financial Officer Jimmy Patronis. “I’m pleased that Florida’s business owners will benefit from another year of rate relief and look forward to keeping Florida the best place to live, work, and run a business.”

“Today’s announcement means more cost saving opportunities for every business operating in Florida,” said Agriculture Commissioner Wilton Simpson. “Florida is committed to supporting small businesses and I look forward to seeing another year of reduced workers’ compensation rates.”

“I’m pleased to announce that Florida businesses will see a reduction in workers’ compensation rates for the seventh consecutive year,” said Insurance Commissioner Michael Yaworsky. “It’s clear the workers’ compensation market in Florida is stable and competitive; I’m confident lower workers’ compensation rates will assist in ensuring that all of Florida’s businesses have the opportunity to succeed in our state.”

OIR hosted a recorded, virtual public hearing regarding the Workers’ Compensation Rates and Rating Values submitted by NCCI. A recording of the hearing is available here.

Additional information regarding the NCCI public hearing and rate filing is available on OIR’s website here.

About the OIR

The Florida Office of Insurance Regulation (OIR) has primary responsibility for regulation, compliance, and enforcement of statutes related to the business of insurance and the monitoring of industry markets. For more information about OIR, please visit our website or follow us on X @FLOIR_comm.

nonPareil Orlando Presents: Sipping for Scholarships –Empowering Adults with Autism

Press Room Team — Wed, 08 Nov 2023 14:28:39 +0000

Orlando, Florida (November 08, 2023) – nonPareil Orlando, an organization dedicated to empowering
adults with autism, invites the community to join a transformative event, Sipping for Scholarships,
taking place on Friday, November 17 at Venue on Lake Lily Maitland. This unique evening aims to
provide access to life-changing work readiness program for adults with autism in Central Florida.

Event Highlights:

Fashion show, art exhibits, and performances: Experience a showcase of creativity with a
unique fashion show, captivating art exhibits, and performances by the exceptionally talented
nonPareil Orlando students.
Drinks, Music, Hors d’oeuvres: Enjoy a delightful evening filled with drinks, music, and
delectable hors d’oeuvres, creating a perfect atmosphere for socializing and supporting a
meaningful cause.
Sip with Purpose: Your participation in this event goes beyond just a night out—it supports a
noble cause. By sipping for scholarships, you contribute to empowering adults with autism
through nonPareil’s tech training and work readiness programs.

“A marvelous outcome for my son. He has grown from a student (crew member) to a team leader, to
a paid lab assistant” says “Parent of D.R.”

According to recent statistics, 89% of adults with autism face unemployment or underemployment.
nonPareil aims to change this narrative by building a better future for these individuals. Through tech
training and work readiness programs, nonPareil empowers students to follow their passions and
pursue their goals.

nonPareil is a post secondary, nonprofit serving adults with autism through work-readiness training
with hands on technical instruction, and social engagement opportunities.

For more information on Sipping for Scholarships, please visit: https://bitly.ws/XX6M

Providing Community Mental Health Services, One Therapy Session at a Time

Press Room Team — Sun, 28 May 2023 22:15:30 +0000

Whether it’s talking to clients on a couch—or walking on a scenic path—the owner of a therapy practice explains how mental health services can improve society.

Wanting to provide therapeutic care to the same community she grew up in, Melissa Bercier, PhD, LCSW, started facilitating “walk and talk therapy” with clients on the Illinois Prairie Path in 2012. Within two months the business grew so quickly that she set up a formal practice, Couch Clarity in Elmhurst, IL, and now provides traditional “on the couch” therapy and trains new private practice therapists.

To spotlight Small Business Month and Mental Health Awareness Month in May we asked Bercier, a member of the U.S. Chamber’s Small Business Council, to share her insight on being both a small business owner and mental health provider in today’s environment. The responses below have been edited for clarity.

Q. How has your business grown over the last decade? Is there a specific therapeutic service you are currently focusing on in your practice?

Bercier: I started providing walk and talk therapy to clients on the Illinois Prairie Path, a beautiful walking, running, and biking path. Within two months I needed to find a building to rent for my “home base” to also provide traditional “on the couch” therapy to those who preferred not to walk but just talk. My main interest has always been to “help the helper” and to provide training to new private practice therapists. Recently, I have created a Couch Clarity 101 program where I train new private practitioners.

Q. What are some of the newer methods of treatment that you’ve recently adopted and seen success with?

Bercier: We were forced to incorporate teletherapy with our clients due to the pandemic. While this is not the best form of therapy to provide due to not having the client in your office in person, teletherapy has allowed us to reach clients that we might not have otherwise due to proximity or scheduling issues. We are grateful to have teletherapy as an option, but we prefer to offer in-person therapy—especially for children and teens.

Q. Why are therapeutic mental health services important for people, and for communities?

Bercier: Our mental health is the hub of all the things that we do. Decision making, impulsivity, insight, personality, moods—all make up our mental health. Services that are easily accessible in communities can only improve our society’s overall mental health and safety. At Couch Clarity, we feel that we are helping the people of our community be better workers, better students, better family members, better friends, and overall better humans.

Q. What is it like running a small business in the mental health field?

Bercier: Running a private practice is very fulfilling. We often get positive feedback not only from our clients but from the members of our community. People seem to be very grateful that we offer mental health services within our community. We have created such a solid foundation of mental health help that our clients refer their families and friends regularly which keeps our referral base flowing and has led to our overall growth.

Government Price Controls Limit Access to Medicine and Stifle American Innovation

Press Room Team — Sun, 23 Apr 2023 17:48:35 +0000

Secretary Becerra and the Department of Health and Human Services (HHS) have started the process of imposing government price controls on critical medical treatments. While this price control regime was authorized by the recently enacted Inflation Reduction Act, it will have devastating consequences for patients who are counting on new life-saving drugs.

 Already one company has dropped a blood cancer drug from its research and development pipeline because they “couldn’t make the math work.” Eli Lilly CEO Dave Ricks said, “In light of the Inflation Reduction Act, this program no longer met the threshold for continued investment.”
Alnylam ceased their research and development into a new treatment for a rare eye disease due to the need “to evaluate the impact of the Inflation Reduction Act.”
Similarly, Novartis warned that the IRA could discourage investment in its most promising areas of research and development: RNA and radioligands.

And it is likely to get worse. The U.S. Chamber Patient Access Report demonstrates that patients in countries that impose price controls have less access to new treatments.

 Before the IRA introduced price controls, the United States had launched 80% of the 104 new oncology products released globally, compared to Europe’s 58%.
Meanwhile, in other developed countries with price controls in place, patients faced long wait times to access new treatments. For instance, in Germany, patients waited an average of 133 days, while in Spain, some had to wait up to 500 days.

Unless we act, this is going to happen to us.

How can I help? Urge your member of Congress to protect American patients and stop this price control regime.

More than 30,000 Floridians Assisted through First Lady DeSantis’ Hope Florida –A Pathway to Prosperity

Press Room Team — Mon, 13 Jun 2022 16:44:56 +0000

TALLAHASSEE, Fla., June 10, 2022.- The First Lady Casey DeSantis announced that Hope Florida – A Pathway to Prosperity has now helped more than 30,000 Floridians on their road to economic self-sufficiency.

The Hope Florida – A Pathway to Prosperity program, spearheaded by First Lady DeSantis and implemented by the Florida Department of Children and Families (DCF), utilizes Care Navigators to assist Floridians in need by identifying goals and removing barriers to economic self-sufficiency through local, community-based partners, including the private sector, faith-based institutions, and nonprofit organizations.

“I am extremely proud of the work that has been done to help Floridians find hope for a better life and realize their potential,” said First Lady Casey DeSantis. “It is heartening to see needs across the state being met by Floridians for Floridians with the expansion of Hope Florida – A Pathway to Prosperity. In the months ahead, we will be looking at ways to build off this momentum and continue to grow the program to connect individuals across the state with entities that seek to serve others in their community.”

A recent Hope Florida – A Pathway to Prosperity participant praised her Care Navigator, Lynda Anglade, for the referrals she received after losing her job and facing post-pandemic health issues. “Her kind heart and professional assistance kept me sane and helped me gather all the information needed for these services,” said Shari G. “I am forever grateful and pray these services continue so they are able to help those in need.”

Hope Florida – A Pathway to Prosperity began as a pilot in August 2020 and was expanded under the leadership of the First Lady in September 2021. The program assists individuals and families with resolving immediate needs or long-term goals, including Floridians receiving public benefits, current and former foster youth, and pregnant mothers contending with substance misuse. Through the Care Navigators, in partnership with non-profit organizations, faith-based institutions, and private sector businesses, Floridians in need of assistance are overcoming barriers and achieving life-changing goals in the areas of education and employment.

“This program provides an opportunity for the Department to partner with Floridians in need on their journey to economic self-sufficiency through the thoughtful and customized activation of local resources,” said DCF Secretary Shevaun Harris. “We are front-loading our service array to prevent families and individuals from finding themselves in a crisis situation further down the road. We see every interaction as an opportunity to help.”

Through Hope Florida – A Pathway to Prosperity, Floridians in need of assistance are provided with tools and community connections that will ultimately lead them on a path to self-sufficiency and empower them to make changes that will have long-term positive effects on them, their families, and their communities.

To receive support from Hope Florida – A Pathway to Prosperity, Floridians can call the Hope Line at 850-300-HOPE. Additional information can be found at HopeFlorida.com.

More than $60 Million to Public Health AmeriCorps Programs awarded as part of Historic Partnership

Press Room Team — Wed, 06 Apr 2022 23:59:59 +0000

WASHINGTON, D.C. – AmeriCorps, the federal agency for national service and volunteerism, and the Centers for Disease Control and Prevention announced more than 80 grant awards to state and local organizations for Public Health AmeriCorps, a partnership to support the recruitment, training, and development of a new generation of public health leaders. The first-year grants, totaling more than $60 million, will allow Public Health AmeriCorps programs to recruit nearly 3,000 AmeriCorps members.

Public Health AmeriCorps, which is supported by a five-year, $400 million investment from the American Rescue Plan Act, will help meet public health needs of local communities by providing surge capacity and support while also creating pathways to public health-related careers. AmeriCorps members will serve communities by providing health education, supporting health-related research, assisting with testing and vaccination efforts and more. View a full list of opportunities on our website.

“Throughout the COVID-19 pandemic, AmeriCorps has established aid networks, supported vaccination efforts and provided food and resources to those in need,” said Michael D. Smith, AmeriCorps CEO. “Public Health AmeriCorps is a first of its kind response to the disproportionate impact of the COVID-19 pandemic and social determinants of health. These new AmeriCorps members will add capacity to strained public health systems and build a career pathway for future public health leaders from underserved communities.”

While many of the grants awarded today fund initiatives focused on COVID-19 response, the program also will help communities address broader public health needs that have been exacerbated by the pandemic, including mental health. The program will build on expertise, best practices and lessons learned from existing CDC, AmeriCorps and other public health programs.

“The COVID-19 pandemic highlighted the need for a more robust public health workforce,” said CDC Director Rochelle P. Walensky, MD, MPH. “We at CDC are committed to supporting efforts that build a strong and diverse workforce that can swiftly respond to and address public health challenges. Public Health AmeriCorps is an essential component of the critical effort to build our nation’s next generation of public health leaders.”

Public Health AmeriCorps is an example of a whole of government approach to address our nation’s most pressing challenges. The partnership between AmeriCorps and the CDC leverages the expertise of both agencies, capitalizing on AmeriCorps’ experience managing some of the most prominent public service and workforce development programs in the nation while benefitting from CDC’s technical expertise as the country’s leading public health agency.

The Public Health AmeriCorps comes as part of a larger $7 billion investment in the public health workforce announced by the Biden-Harris Administration. The next Public Health AmeriCorps federal funding opportunity is expected to be released in Fall 2022.

AmeriCorps continues to invest in the nation’s COVID-19 recovery. With existing programs in more than 40,000 locations across the country, AmeriCorps is uniquely positioned to bolster community response efforts. For the past two years, thousands of AmeriCorps members and AmeriCorps Seniors volunteers across all 50 states and U.S. territories have continued their service, quickly adapting to meet the changing needs caused by the pandemic and have provided vital support, community response, and recovery efforts, providing support to more than 12 million Americans, including 2.5 million people at vaccination sites.

AmeriCorps, the federal agency for volunteerism and national service, provides opportunities for Americans to serve their country domestically, address the nation’s most pressing challenges, improve lives and communities, and strengthen civic engagement. Each year, the agency invests in grants for local nonprofit, community, tribal, and state organizations; places more than 250,000 AmeriCorps members and AmeriCorps Seniors volunteers in intensive service roles; and empowers millions more to serve as long-term, short-term, or one-time volunteers. Learn more at AmeriCorps.gov.

Attgeno announces the collaboration with a world-leading research center for pulmonary hypertension

Press Room Team — Thu, 17 Mar 2022 16:38:28 +0000

March 17, 2022.- Attgeno AB today announces a research collaboration targeting to explore Supernitro (PDNO) as a new potential treatment for pulmonary hypertension by investigating specific drug mechanisms in the pathophysiology of the disease. The collaboration with TransMIT GmbH, the technology transfer agency of Justus-Liebig-University of Giessen (JLU) involves the TransMIT-Project Division for Pulmonary Pharmacotherapy, led by Prof. Dr. Ralph Schermuly, located at JLU with its Excellence Cluster Cardio-Pulmonary Institute (CPI), Germany.

Professor Ralph Schermuly and Professor Ardeschir Ghofrani of the TransMIT-Project Division for Pulmonary Pharmacotherapy located at JLU and CPI commented: “Advancing translational science in the field of pulmonary hypertension is critical to better explore potential new treatments. Supernitro, a novel intravenous nitric oxide-donor, might offer an innovative treatment option for patients with pulmonary hypertension.”

“I am very happy that Attgeno enters into this research partnership with TransMIT-Project Division for Pulmonary Pharmacotherapy located at JLU and the CPI. This key cooperation will help to elucidate the full potential of Supernitro. Professor Schermuly and Professor Ghofrani have an impressive track record and have been involved in almost every new drug for pulmonary hypertension entering the market during the last 20 years”, says Per Agvald, Attgeno’s co-founder and CEO.

About Attgeno

Attgeno AB is a privately held Swedish biotech company devoted to development and commercialization of innovative and effective nitric oxide-donating drugs. Its leading drug candidate Supernitro (PDNO) is currently in early (phase I/IIa) clinical development. For further information, please visit www.attgeno.com.

About Supernitro (PDNO)

Supernitro is administered as an intravenous infusion, which upon entry into the blood, has an ultra-short half-life rapidly releasing its active moiety nitric oxide (NO). As a result, most of its NO is released just through the short passage through the lung blood circulation where it reacts with the blood vessels and causes them to dilate. By the donation of NO in the lungs, Supernitro replaces the decrease in NO production that is a well-known consequence of different diseases leading to increased risk for pulmonary hypertension.

About pulmonary hypertension

Pulmonary hypertension is a condition of increased blood pressure in the arteries of the lungs. Symptoms include shortness of breath, fainting, tiredness, chest pain, swelling of the legs, and a fast heartbeat. Onset is typically gradual and prognosis poor.

The pathogenesis of pulmonary hypertension involves the narrowing of blood vessels connected to and within the lungs. This makes it harder for the heart to pump blood through the lungs, as it is much harder to make water flow through a narrow pipe as opposed to a wide one. Over time, the affected blood vessels become stiffer and thicker, in a process known as fibrosis. The mechanisms involved in this narrowing process include vasoconstriction, thrombosis, and vascular remodelling.

Governor DeSantis Condemns Biden Administration’s Haphazard Decision to Revoke Authorization of Lifesaving Monoclonal Antibody Treatments

Press Room Team — Tue, 25 Jan 2022 17:55:00 +0000

TALLAHASSEE, Fla. January 25, 2022.- Governor Ron DeSantis is demanding the Biden Administration reverse its sudden and reckless decision to revoke emergency use authorization (EUA) for Regeneron and Eli Lilly monoclonal antibody treatments. This abrupt and unilateral action by the Biden Administration will prevent access to lifesaving treatments for Floridians and Americans.

“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” said Governor Ron DeSantis. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”

“In our field of medicine, when someone comes to you seeking a treatment that could save their life, it is essential to have treatment options to ensure health care providers can make the best decisions for their patients,” said Surgeon General Dr. Joseph Ladapo. “The Federal Government has failed to adequately provide the United States with adequate outpatient treatment options for COVID-19. Now, they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus.’”

As a result of this abrupt and clinically unsupported action, the appointments for more than 2,000 Floridians to receive this treatment were canceled on January 25, 2022, alone. This decision was made solely by Biden’s Food and Drug Administration (FDA) without advance warning to states or health providers and without clinical data to support the decision. The deliberate decision by the Biden Administration to make this announcement effective immediately, through a press release, actively prevents states and health care providers from making real-time operational decisions that save lives.

Over the course of the past two years, scientists and researchers across the nation have worked hard to bring us treatments that are both safe and effective. One of these treatments has been monoclonal antibodies. This treatment has saved thousands of lives in Florida and across our nation.