Things you should know about Social Security
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Los Angeles Times
3 hours ago
- Los Angeles Times
Judge orders RFK Jr.'s health department to stop sharing Medicaid data with deportation officials
WASHINGTON — A federal judge ordered the nation's health department to stop giving deportation officials access to the personal information — including home addresses — of all 79 million Medicaid enrollees. The U.S. Department of Health and Human Services first handed over the personal data on millions of Medicaid enrollees in a handful of states in June. After an Associated Press report identified the new policy, 20 states filed a lawsuit to stop its implementation. In July, the Centers for Medicare and Medicaid Services entered into a new agreement that gave the Department of Homeland Security daily access to view the personal data — including Social Security numbers and home address — of all the nation's 79 million Medicaid enrollees. Neither agreement was announced publicly. The extraordinary disclosure of such personal health data to deportation officials in the Trump administration's far-reaching immigration crackdown immediately prompted the lawsuit over privacy concerns. The Medicaid data sharing is part of a broader effort by the Trump administration to provide DHS with more data on migrants. In May, for example, a federal judge refused to block the Internal Revenue Service from sharing immigrants' tax data with Immigration and Customs Enforcement to help agents locate and detain people living without legal status in the U.S. The order, issued by federal Judge Vince Chhabria in California, temporarily halts the health department from sharing personal data of enrollees in those 20 states, which include California, Arizona, Washington and New York. 'Using CMS data for immigration enforcement threatens to significantly disrupt the operation of Medicaid—a program that Congress has deemed critical for the provision of health coverage to the nation's most vulnerable residents,' Chhabria wrote in his decision, issued on Tuesday. Chhabria, an appointee of President Barack Obama, said that the order will remain in effect until the health department outlines 'reasoned decisionmaking' for its new policy of sharing data with deportation officials. A spokesperson for the federal health department declined to directly answer whether the agency would stop sharing its data with DHS. HHS has maintained that its agreement with DHS is legal. Immigrants who are not living in the U.S. legally, as well as some lawfully present immigrants, are not allowed to enroll in the Medicaid program that provides nearly free coverage for health services. But federal law requires all states to offer emergency Medicaid, a temporary coverage that pays only for lifesaving services in emergency rooms to anyone, including non-U.S. citizens. Medicaid is a jointly funded program between states and the federal government. Immigration advocates have said the disclosure of personal data could cause alarm among people seeking emergency medical help for themselves or their children. Other efforts to crack down on illegal immigration have made schools, churches, courthouses and other everyday places feel perilous to immigrants and even U.S. citizens who fear getting caught up in a raid. 'Protecting people's private health information is vitally important,' Washington state's Attorney General Nick Brown said in a statement. 'And everyone should be able to seek medical care without fear of what the federal government may do with that information.' Seitz and Kindy write for the Associated Press.
7 hours ago
Judge orders RFK Jr.'s health department to stop sharing Medicaid data with deportation officials
WASHINGTON -- A federal judge ordered the nation's health department to stop giving deportation officials access to the personal information — including home addresses — of all 79 million Medicaid enrollees. The U.S. Department of Health and Human Services first handed over the personal data on millions of Medicaid enrollees in a handful of states in June. After an Associated Press report identified the new policy, 20 states filed a lawsuit to stop its implementation. In July, the Centers for Medicare and Medicaid Services entered into a new agreement that gave the Department of Homeland Security daily access to view the personal data — including Social Security numbers and home address — of all the nation's 79 million Medicaid enrollees. Neither agreement was announced publicly. The extraordinary disclosure of such personal health data to deportation officials in the Trump administration's far-reaching immigration crackdown immediately prompted the lawsuit over privacy concerns. The Medicaid data sharing is part of a broader effort by the Trump administration to provide DHS with more data on migrants. In May, for example, a federal judge refused to block the Internal Revenue Service from sharing immigrants' tax data with Immigration and Customs Enforcement to help agents locate and detain people living without legal status in the U.S. The order, issued by federal Judge Vince Chhabria in California, temporarily halts the health department from sharing personal data of enrollees in those 20 states, which include California, Arizona, Washington and New York. 'Using CMS data for immigration enforcement threatens to significantly disrupt the operation of Medicaid—a program that Congress has deemed critical for the provision of health coverage to the nation's most vulnerable residents,' Chhabria wrote in his decision, issued on Tuesday. Chhabria, an appointee of President Barack Obama, said that the order will remain in effect until the health department outlines 'reasoned decisionmaking' for its new policy of sharing data with deportation officials. A spokesperson for the federal health department declined to directly answer whether the agency would stop sharing its data with DHS. HHS has maintained that its agreement with DHS is legal. Immigrants who are not living in the U.S. legally, as well as some lawfully present immigrants, are not allowed to enroll in the Medicaid program that provides nearly free coverage for health services. But federal law requires all states to offer emergency Medicaid, a temporary coverage that pays only for lifesaving services in emergency rooms to anyone, including non-U.S. citizens. Medicaid is a jointly funded program between states and the federal government. Immigration advocates have said the disclosure of personal data could cause alarm among people seeking emergency medical help for themselves or their children. Other efforts to crack down on illegal immigration have made schools, churches, courthouses and other everyday places feel perilous to immigrants and even U.S. citizens who fear getting caught up in a raid. 'Protecting people's private health information is vitally important,' Washington state's Attorney General Nick Brown said in a statement. 'And everyone should be able to seek medical care without fear of what the federal government may do with that information.'
Business Wire
8 hours ago
- Business Wire
Spruce Biosciences Announces Integrated Long-Term Clinical Data of Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) Demonstrating Profound and Durable Efficacy and Safety in Patients with Sanfilippo Syndrome Type B (MPS IIIB)
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Spruce Biosciences, Inc. (OTCQB: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced results from a long-term data integration of tralesinidase alfa enzyme replacement therapy (TA-ERT) clinical program in patients with Sanfilippo Syndrome Type B (MPS IIIB). Spruce integrated and evaluated group-level efficacy data for cerebral spinal fluid heparan-sulfate non-reducing end (CSF HS-NRE), cortical grey matter volume (CGMV), and Bayley-III Cognitive Raw Score (BSID-C), the cognitive subscale of the Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III), as well as safety data over a five-year period from clinical studies 201, 202, and 401. Data from treated patients (n=22) in the studies 201, 202, and 401 was compared with data from untreated patients with MPS IIIB in natural history studies 901 and 902. 'These data demonstrate a rapid, profound, and durable effect of ICV-administered TA-ERT on normalizing CSF HS-NRE, the pathogenic factor leading to neurodegeneration, and in stabilizing CGMV and cognitive function, relative to the declines observed in untreated children with Sanfilippo Syndrome Type B (MPS IIIB) in the natural history studies,' said Paul Harmatz, M.D., Principal Investigator in studies 901, 201, and 202 and Professor in Residence, Department of Pediatrics, University of California, San Francisco (UCSF) and UCSF Benioff Children's Hospital Oakland. 'This is an important development toward relief for children and families whose lives are impacted by this devastating condition.' 'Convincing positive outcomes have been experienced by families who resoundingly state that the benefits of TA-ERT outweigh risks in their real-world experiences,' said Cara O'Neill, M.D., FAAP, Co-Founder and Chief Science Officer of Cure Sanfilippo Foundation. 'Biomarker data, along with promising clinical outcomes, are significant and meaningful from the perspective of the patient community. Currently, there is no U.S. FDA-approved therapy for the treatment of MPS IIIB, and disease management consists of limited palliative care. We are eager to see TA-ERT advance under the accelerated approval pathway.' Cerebral Spinal Fluid Heparan-Sulfate Non-Reducing End (CSF HS-NRE) Integrated group-level data from clinical studies 201, 202, and 401 demonstrate that TA-ERT therapy significantly reduced to normal or near normal CSF HS-NRE levels over a five-year period (Figure 1). At 240 weeks, CSF HS-NRE decreased 91.5 ng/mL from baseline (95% CI: -102.10, -80.90; p<0.0001). Most participants experienced normalization of CSF HS-NRE levels eight weeks after initiating therapy. In a 2024 meeting with the U.S. Food and Drug Administration (FDA), the FDA confirmed that CSF HS-NRE is a surrogate biomarker reasonably likely to predict clinical benefit and could serve as a basis for accelerated approval. Cognitive Function In untreated patients with MPS IIIB, cognitive function peaks at around four years of age and then declines over time. In contrast, children with established disease treated with TA-ERT experienced stable cognitive function over time (Figure 2). Untreated children in the natural history studies showed a decline in cognition beginning at approximately five years of age that progressively worsened over time, while cognition in the TA-ERT treated group remained stable. Using a model-based approach, the mean (95% CI) BSID-C over six to 10 years of age was significantly higher in patients treated with TA-ERT, relative to untreated, age-matched children, with differences evident at six years of age (group difference: 10.67, 95% CI: 3.23, 18.11; p=0.005). At 10 years of age, the difference in BSID-C scores between groups increased to 34.66 (95% CI: 24.38, 44.93; p<0.0001). Although TA-ERT treatment stabilized BSID-C scores on average, increases in BSID-C scores were more commonly observed in subjects who initiated therapy at younger ages with higher baseline cognitive function and prior to the establishment of meaningful neurodegeneration. The BSID-C is anticipated to be the primary endpoint for the post-marketing clinical trial. Cortical Grey Matter Volume (CGMV) TA-ERT therapy was also associated with stabilization of CGMV, relative to the decline in CGMV observed in untreated children due to the progressive neurodegenerative nature of MPS IIIB (Figure 3). While CGMV should increase with age in children up to five years of age, there was an average loss of ~32 mL over 48 weeks in untreated children with MPS IIIB observed in study 901. Consistent with TA-ERT's mechanism of action, decreases in CGMV were observed during the initial 24 weeks of TA-ERT treatment, likely reflecting intracellular clearance of cerebral spinal fluid heparan sulfate (CSF HS) and CSF HS-NRE. CGMV stabilized from weeks 48 to 240 with TA-ERT treatment. Safety TA-ERT therapy exposure for up to 7.3 years has demonstrated an adequate safety profile in a serious and fatal disease for which no treatment is currently available. The mean (SD) exposure to TA-ERT was 4.2 (2.0) years. No deaths occurred throughout study 201 and its long-term extension studies 202 and 401. The most frequent treatment-emergent adverse event (TEAE) by preferred term (reported in ≥40% of participants) was vomiting (22 [100%]), followed by pyrexia (20 [90.9%]), upper respiratory tract infection (17 [77.3%]), pleocytosis (11 [50.0%]), COVID-19 infection (10 [45.5%]), and diarrhea (9 [40.9%]). Four (18%) patients discontinued treatment, although three (14%) discontinuations were due to hydrocephalus, a known complication of MPS IIIB. Adverse events related to the ICV device were consistent with other therapies administered by the ICV route. About Sanfilippo Syndrome Type B (MPS IIIB) MPS IIIB is an ultra-rare, serious, and fatal genetic disease characterized by deficiency in N-Acetyl-Alpha-Glycosaminidase (NAGLU), an enzyme required for the catabolism of heparan sulfate (HS) in lysosomes. It is estimated that MPS IIIB affects fewer than 1:200,000 people in the United States (U.S.), but the true incidence and prevalence are difficult to ascertain because MPS IIIB is a disease currently not included in newborn screening. The accumulation of toxic levels of cerebral spinal fluid heparan sulfate in the brain is the underlying pathophysiology of MPS IIIB. Although signs and symptoms of MPS IIIB can vary amongst affected individuals, progressive neurodegeneration typically follows a predictable path to brain atrophy, cognitive and developmental impairment, hyperactivity with aggressive and destructive behavior, delayed speech, hearing loss, and motor skill deficits. Somatic manifestations include coarse facial features, hepatosplenomegaly, and gastrointestinal symptoms. The final stage of MPS IIIB is typically marked by severe dementia, loss of motor function, and seizure activity, with patients largely bed-ridden and requiring constant care, requiring feeding tubes for hydration and nutrition, and ultimately leading to death. The estimated life expectancy of individuals with MPS IIIB ranges from 15 to 19 years of age. Currently, there are no FDA-approved therapies for MPS IIIB, and management of the disease consists of limited palliative care to improve quality of life. About Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) is a fusion protein comprised of recombinant human alpha-N-acetylglucosaminidase (rhNAGLU). TA-ERT is intended as an enzyme replacement therapy for the treatment of patients with MPS IIIB (Sanfilippo Syndrome Type B) who lack rhNAGLU enzyme activity. TA-ERT is expected to restore rhNAGLU enzyme activity in the central nervous system following intracerebroventricular injection. rhNAGLU typically lacks the mannose-6-phosphate residues that are essential for efficient cellular uptake via the M6P receptor pathway. As a result, the naked enzyme is poorly absorbed by cells, including neurons. To address this challenge, TA-ERT is fused to an insulin-like growth factor 2 peptide, which binds to the cation-independent mannose-6-phosphate on cell surfaces. This fusion enables the enzyme to be internalized and delivered to the lysosome, thereby enhancing its therapeutic potential for treating MPS IIIB. By restoring NAGLU enzymatic activity and promoting clearance of lysosomal heparan sulfate and heparan sulfate non-reducing end in the brain, TA-ERT therapy is expected to preserve neuronal cell health and potentially halt or slow the neurological decline and improve clinical outcomes in affected patients. TA-ERT has been evaluated in three clinical studies in participants with MPS IIIB: the interventional study 201 and extension studies 202 and 401. Twenty-two individuals with MPS IIIB have been administered TA-ERT therapy. TA-ERT has demonstrated an adequate safety profile based on integrated five years of safety data. About Spruce Biosciences Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. To learn more, visit and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the ability to seek accelerated approval of TA-ERT for MPS IIIB based on existing clinical data. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'anticipate', 'will', 'potential', 'intend', 'expect' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce's business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce's filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
