The Assistance Fund, an independent charitable patient assistance organization that helps patients and families facing high medical out-of-pocket costs, today announced the launch of a new financial assistance program for people living with acid sphingomyelinase deficiency (ASMD). The program is designed to help eligible individuals pay for their out-of-pocket medical expenses related to ASMD, such as copays, health insurance premiums, therapy administration costs, prescribing-physician copayments, treatment-related travel costs, and genetic testing.

"People living with acid sphingomyelinase deficiency face a host of challenges including basic day-to-day activities," said Joslyn Crowe, Executive Director of the National Niemann Pick Disease Foundation. "We are thrilled that The Assistance Fund's new program will help so many families in our community access a treatment they need to improve their quality of life."

People living with acid sphingomyelinase deficiency, also known as Niemann-Pick Types A and B, have an SMPD1 gene mutation and lack an important enzyme required to break down the body's sphingomyelin. Their symptoms may start as jaundice, constipation, and nausea, but eventually lead to organ malfunction.[1] Laboratory and genetic testing is important for identifying whether a patient has Type A or B. 

"Access to testing and treatment is essential for patients and families facing an acid sphingomyelinase deficiency diagnosis," said Judith M. Fox, Interim President and CEO of The Assistance Fund. "Thanks to our generous donors, The Assistance Fund's new Acid Sphingomyelinase Deficiency Financial Assistance Program will ease the worry of patients and allow them to get the care they need."

To learn more or determine eligibility for financial support, visit tafcares.org or call (855) 233-0505 to speak with a Patient Advocate.

A list of all the disease programs available from The Assistance Fund can be found on the website tafcares.org.

About The Assistance Fund

The Assistance Fund (TAF) is an independent charitable patient assistance organization that helps patients and families facing high medical out-of-pocket costs by providing financial assistance for their copayments, coinsurance, deductibles, and other health-related expenses. The Assistance Fund currently manages 80 disease programs, each of which covers all FDA-approved medications that treat a specific disease named in the disease program. Since its founding in 2009, TAF has helped more than 160,000 children and adults access the treatment they need to stay healthy or manage a life-threatening, chronic, or rare disease. To learn more about The Assistance Fund, or for information on how to donate, please visit tafcares.org. 

Media Contact

Margaret Figley

Senior Director of Communications

[email protected]

[1] National Niemann Pick Disease Foundation, "Niemann-Pick ASMD," https://nnpdf.org/niemann-pick-asmd/, accessed January 2023.

The Radiology Business Management Association (RBMA), Emergency Department Practice Management Association (EDPMA), Healthcare Business Management Association (HBMA) and Medical Group Management Association (MGMA) all strongly oppose the U.S. Centers for Medicaid and Medicare Services (CMS) 600% administrative fee increase to utilize the Independent Dispute Resolution (IDR) process provided by the No Surprises Act (NSA). The Associations represent radiology and emergency healthcare clinicians across the country, and they call on CMS to immediately reverse this decision and on Congress to initiate oversight proceedings on this executive action.

"RBMA fully supports Congress' intention of the NSA to protect patients from unexpected medical bills, and our physicians are committed to providing affordable, quality care to their patients across the country," said Bob Still, Executive Director of the Radiology Business Management Association (RBMA). "As such, this 600% fee increase under the NSA puts physicians in the middle of health plans and CMS' inadequate implementation process of those plans. By pricing out the method for dispute resolution with this excessive fee, our providers' ability to perform important services, like cancer screenings, will be significantly hindered and inevitably hurt the healthcare of American consumers."

"While EDPMA understands CMS' need to address the IDR backlog, exorbitant fees are simply not the answer. These abrupt, inappropriate increases unnecessarily burden emergency medicine clinicians and significantly deter clinician's access to the method of dispute resolution provided by Congress. This is another substantial mis-step that fails to address fundamental operational and policy-related issues involved in the No Surprises Act," said Don Powell, DO, FACEP, EDPMA Chair. "CMS's actions prevent the level playing field provided in the law, and contrary to the law's interests, will drive more payer-driven contact terminations, while crippling the cash flow that supports emergency care for patients."

"Increasing the administrative fees for the IDR process by 600% is not the appropriate way to address the backlog of IDR disputes," said Landon Tooke, CHC, CPCO, President of HBMA's Board of Directors. "The new fee - which is not reimbursed to the initiating party - is higher than many of the disputed payment amounts. This unfairly disincentivizes clinicians from utilizing the IDR process and does not align with how Congress intended this process to be used. The higher fee does not address the root cause of the backlog, which is health plans forcing many practices out of their networks which puts a greater burden on the IDR process. While we understand the need to address the high volume of initiated disputes, health plans share the responsibility to reduce the backlog by properly communicating if the NSA protections apply to a specific scenario and by negotiating in good faith during the open negotiation window."

"MGMA supports the goals underpinning the No Surprises Act — we believe patients should have accurate and timely access to the costs of items and services. However, the law must be implemented in a manner that does not create undue burden on our nation's medical groups, nor impede practices' ability to deliver care," said Anders Gilberg, Senior Vice President of Government Affairs for MGMA. "Increasing the administrative fee for the IDR process will disproportionally effect providers who are already suffering from significant financial strain stemming from staffing shortages, wage inflation, and drastic cost increases across the board. We encourage CMS to swiftly reevaluate the administrative fee, to make it equitable so as to not prohibit medical groups' ability to initiate the IDR process to settle payment disputes with health plans as granted by the law."

The Associations call on CMS to fairly rebalance the IDR process, keep administrative fees at fair and stable 2022 levels, and address their unsustainable backlog of claims under NSA. To ensure this appropriate and much needed reform at CMS, the Associations call on the new Congress to initiate oversight proceedings on these processes at CMS.

After first announcing in October 2022 that the 2023 administrative fee would remain stable, in a last-minute move in late December 2022, CMS announced a 600% increase in non-refundable administrative fees for any party to file out-of-network claims disputes through the NSA's IDR process. Additionally, CMS had previously announced fee increases of up to 117% for IDR entities. The dramatic, unprecedented increase in initial fees with less than a week's notice disproportionately affects providers, favors health plans, and will hurt consumers.

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About RBMA:

The Radiology Business Management Association (RBMA) is an industry-leading organization comprised of more than 2,100 professionals who focus on the business of radiology. RBMA members support diagnostic imaging, interventional radiology and radiation oncology providers in the full spectrum of practice settings. RBMA connects members nationwide to valuable information, education, and practice-related resources and serves as an authoritative industry voice on behalf of shared member interests.

About EDPMA:

The Emergency Department Practice Management Association (EDPMA) is the nation's largest professional physician trade association focused on the delivery of high-quality, cost-effective care in the emergency department. EDPMA's membership includes emergency medicine physician groups of all sizes, as well as billing, coding, and other professional support organizations that assist healthcare providers in our nation's emergency departments. Together, EDPMA's members deliver (or directly support) health care for about half of the 146 million patients that visit U.S. emergency departments each year. Visit http://www.edpma.org.

About HBMA:

The Healthcare Business Management Association (HBMA), a non-profit professional trade association, is a major voice in the revenue cycle management industry in the United States. HBMA is a recognized revenue cycle management (RCM) authority by both the commercial insurance industry and the governmental agencies that regulate or otherwise affect the U.S. healthcare system. To learn more, visit www.hbma.org. 

About MGMA:

Founded in 1926, the Medical Group Management Association (MGMA) is the nation's largest association focused on the business of medical practice management. MGMA consists of 15,000 group medical practices ranging from small private medical practices to large national health systems representing more than 350,000 physicians. MGMA helps nearly 60,000 medical practice leaders and the healthcare community solve the business challenges of running practices so that they can focus on providing outstanding patient care. Specifically, MGMA helps its members innovate and improve profitability and financial sustainability, and it provides the gold standard on industry benchmarks such as physician compensation. The association also advocates extensively on its members' behalf on national regulatory and policy issues. To learn more, go to MGMA.com or follow us on LinkedIn, Twitter and Facebook.

RBMA Media Contact:

Will Sweet
[email protected]

EDPMA Contact:

Cathey Wise
703.506.3282 (direct) l 817.905.3310 (cell)
[email protected] 

HBMA Contact: 

Brad Lund
(877) 640-4262
[email protected]

MGMA Contact:

Emily Dowsett
(703) 376-1134
[email protected]

Neurocentria, Inc., a privately held late-stage biotechnology company developing novel therapies for neurodegenerative and neuropsychiatric disorders, has today announced that Dr. Thomas Südhof, Avram Goldstein Professor in Stanford University School of Medicine and an investigator of the Howard Hughes Medical Institute, has joined the company's Scientific Advisory Board (SAB).

Dr. Südhof's appointment further strengthens the company's scientific resources, in line with the commitment to develop unique therapies for individuals with neurodegenerative and neuropsychiatric disorders.

Dr. Südhof will become the SAB's third expert advisor alongside Dr. Jack Feldman, Distinguished Professor of Neurobiology at the University of California, Los Angeles, and Dr. Thomas Laughren, Former Director of the Division of Psychiatry Products, Center for Drug Evaluation and Research at the U.S. Food and Drug Administration.

On joining the SAB, Dr. Südhof will support the Company's leadership in its oversight and scrutiny of the Company's research and clinical development strategies. The SAB provides general technical guidance, particularly in relation to potential research and clinical development-related transactions.

Dr. Südhof brings unique experience in the field of neuronal function and synaptic transmission, which are central to Neurocentria's approach for developing novel therapies for neurodegenerative and neuropsychiatric disorders. Dr. Südhof won the Nobel Prize in Physiology or Medicine (shared with James Rothman and Randy Sheckman) in 2013 for his discoveries of machinery regulating vesicle traffic, a major transport system in our cells, a mechanism critical for synaptic transmission. He also brings extensive experience in business strategy through his roles as a member of the Board of Directors at Sanofi S.A., one of the world's largest pharmaceutical and healthcare companies, and an Independent Director of CytoDel Inc.

Commenting on the appointment, Dr. Guosong Liu, Chairman and CEO of Neurocentria, said: "I am delighted to welcome Tom to Neurocentria. Our current leading drug candidate was designed based on scientific discoveries related to fundamental synaptic physiology. Tom's expertise in synaptic structure and its function means he is perfectly placed to provide the insight and challenge we need as Neurocentria moves further into developing next-generation medicines for treating neurological disorders."

Biography

Dr. Südhof began his independent career in 1986 at UT Southwestern, where he stayed until 2008 and, among others, was the founding chair of the Department of Neuroscience. In 2008, Dr. Südhof moved to Stanford University and became the Avram Goldstein Professor in the School of Medicine. In addition, Dr. Südhof has been an Investigator of the Howard Hughes Medical Institute since 1986.

Prior to becoming a neuroscientist, Dr. Südhof was trained in the biophysics of subcellular organelles at the Max-Planck-Institut für biophysikalische Chemie and in cholesterol metabolism at UT Southwestern. When Dr. Südhof started his laboratory, he decided to switch to neuroscience to study synapses because of their central, as yet incompletely understood role in brain function. Dr. Südhof's work initially focused on the mechanism of neurotransmitter release, which is the first step in synaptic transmission that accounts for the speed and precision of information transfer in the brain. It was for this work that Dr. Südhof was awarded in 2013 the Albert Lasker Basic Medical Research Award (with Richard Scheller) and the Nobel Prize in Physiology or Medicine (with James Rothman and Randy Schekman). In the last decade, Dr. Südhof's research emphasis has switched to focus on a different unsolved problem in neuroscience that regards synapses, namely how synapses are established specifically between defined pre- and postsynaptic neurons, and how such connections are endowed with specific properties by these neurons. Addressing this fundamental question is essential for understanding how circuits are wired and how they process information, but the basic rules that govern synapse formation and specification are only now beginning to emerge. Elucidating these rules is the goal of Dr. Südhof's present work.

About Neurocentria

Neurocentria is a late-stage biotechnology company dedicated to discovering and developing novel treatments for neurodegenerative and neuropsychiatric disorders. For further information, please visit www.neurocentria.com/about.

Cautionary statement regarding forward-looking statements

This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of our drug candidates, including NRCT-101SR, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; the effects of the outbreak of COVID-19 on our business and results of operations; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for our programs to continue to develop; our ability to protect our intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect our products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.