CMS Energy
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 8.3K
- Market Cap
- -
- Introduction
CMS Energy Corp. engages in the provision of electric and natural gas activities. It operates through the following business segments: Electric Utility, Gas Utility, and NorthStar Clean Energy. The Electric Utility segment focuses on generation, purchase, distribution, and sale of electricity. The Gas Utility segment includes purchase, transmission, storage, distribution, and sale of natural gas. The NorthStar Clean Energy segment is involved in domestic independent power production including the development and operation of renewable generation and the marketing of independent power production. The company was founded in 1987 and is headquartered in Jackson, MI.
Oncocyte Advances Toward Clinical Trial for Organ Transplant Rejection Test Kit
• Oncocyte has received central IRB approval for its clinical trial design and expects to enroll three of the top 10 U.S. transplant centers, representing nearly 10% of annual U.S. transplant volume.
• The company is pursuing FDA authorization via a Class II de novo pathway for its donor-derived cell-free DNA (dd-cfDNA) test kit, which would enable transplant centers to perform rejection testing locally rather than through central labs.
• With a final FDA Q-Sub meeting approaching and CLIA validation already achieved, Oncocyte aims to submit its data package in the second half of 2025, targeting a U.S. market estimated at $500 million annually.
Medicare Coverage of GLP-1 Obesity Drugs Could Add $47.7 Billion to Federal Spending Over 10 Years
• A new microsimulation study projects Medicare expenditures would increase by $47.7 billion over a decade if obesity medications like Wegovy and Zepbound receive Part D coverage.
• While these GLP-1 drugs would generate an estimated $18.2 billion in savings from reduced obesity-related conditions, these benefits are insufficient to offset the high medication costs.
• Researchers found that spending projections vary significantly based on factors like drug pricing, patient adherence, and uptake rates, highlighting the complex fiscal implications of obesity medication coverage.
Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate
• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests.
• The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods.
• The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.
Hospital-Based Addiction Consultation Significantly Improves OUD Treatment Outcomes, Study Shows
• A clinical trial found that hospital-based addiction consultation services more than doubled the rate of medication initiation for opioid use disorder during hospitalization (57.3% vs 26.7% with usual care).
• The Substance Use Treatment and Recovery Team (START) intervention significantly improved post-discharge treatment linkage, with 72% of intervention patients accessing follow-up care compared to 48.1% in the usual care group.
• Researchers suggest the model could address critical gaps in OUD treatment by leveraging hospitalization as an opportunity to overcome barriers like stigma, housing instability, and healthcare access issues.
Trump Administration Halts Medicare and Medicaid Coverage for Anti-Obesity Medications
• The Trump administration has rejected a Biden-era proposal that would have provided Medicare and Medicaid coverage for anti-obesity medications to over 7 million Americans.
• Despite the high cost barrier—with drugs like Wegovy priced at nearly $1,350 for a four-week supply—CMS did not provide specific reasoning for the decision but indicated it may reconsider coverage after further review.
• Medicare will continue covering these medications for specific conditions like heart disease, while 13 states currently offer coverage through their Medicaid programs for obesity treatment.
HHS Announces Major Restructuring with 10,000 Job Cuts, Raising Concerns for Healthcare Regulation and Drug Programs
• The Department of Health and Human Services (HHS) has announced a significant reorganization involving 10,000 layoffs, representing a 20% workforce reduction across agencies including FDA, CMS, and HRSA.
• The restructuring includes merging HRSA with four smaller agencies to create the Administration for a Healthy America (AHA), raising questions about the future administration of critical programs like the 340B drug pricing program.
• HHS Secretary Robert F. Kennedy Jr. has been invited to testify before the Senate Committee on Health, Education, Labor & Pensions on April 10 to address concerns about the reorganization's impact on healthcare regulation and pharmaceutical programs.
Powerful Medical's AI-Driven ECG Model for STEMI Detection Receives FDA Breakthrough Designation
• Powerful Medical's PMcardio STEMI AI ECG model has received FDA Breakthrough Device Designation for detecting ST-elevation myocardial infarction and STEMI equivalents, addressing critical gaps in early heart attack diagnosis.
• The AI-powered technology aims to improve timely intervention for heart attack patients, particularly in rural settings where only 17% of patients reach catheterization labs in time for life-saving treatment.
• This designation provides Powerful Medical with expedited FDA review and improved access to CMS reimbursement mechanisms, potentially transforming emergency cardiac care across the United States.
Vivani Medical to Spin Off Cortigent Neurostimulation Business as Independent Public Company
• Vivani Medical plans to spin off its Cortigent neurostimulation division as an independent Nasdaq-listed company by Q3 2025, allowing each entity to focus on their distinct therapeutic areas.
• Cortigent's technology includes the Orion® artificial vision system for blindness, which completed a 6-year clinical study in 2024 with promising results, and applications for stroke recovery.
• Post-spinoff, Vivani will concentrate exclusively on developing its proprietary NanoPortal™ GLP-1 implants for chronic weight management and type 2 diabetes with once or twice-yearly administration.
CMS Grants ADLT Status to Guardant Health's Shield Blood Test for Colorectal Cancer Screening
• The Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for Guardant Health's Shield blood test, the first FDA-approved blood test for primary colorectal cancer screening.
• Beginning April 1, 2025, Medicare will reimburse the Shield test at $1,495 during the initial nine-month ADLT period, representing a significant increase from the previous $920 reimbursement rate.
• Analysts project the increased reimbursement could generate approximately $10 million in additional revenue for Guardant Health, beyond the company's projected $25-30 million in annual screening revenue.
IRA Price Controls Threaten U.S. Small-Molecule Drug Innovation and Clinical Research
• The Inflation Reduction Act's price control measures could lead to a 29-60% decrease in pharmaceutical R&D by 2039, potentially resulting in up to 342 fewer new drug developments.
• Small-molecule drug funding has plummeted 70% since 2021, with 63% of PhRMA member companies planning to shift R&D focus away from these medicines, significantly impacting future treatments for cancer and other diseases.
• Post-approval clinical trials are particularly threatened, with studies showing 61% of R&D costs occur after initial FDA approval, potentially limiting future therapeutic advances and indication expansions.
GE HealthCare Launches Flyrcado, Revolutionary PET Imaging Agent for Coronary Artery Disease
• GE HealthCare has successfully administered the first doses of Flyrcado, an FDA-approved PET imaging agent for coronary artery disease detection, at Houston Methodist Hospital.
• Flyrcado features a groundbreaking 109-minute half-life, eliminating the need for on-site production and enabling wider distribution to imaging centers across the United States.
• The innovative cardiac PET agent offers superior diagnostic efficacy compared to traditional SPECT MPI, with full commercialization expected by Q2 2025.
Trump Administration Overhauls Healthcare Policy: Major Cuts to Medicaid, RFK Jr. Confirmed as HHS Secretary
• House Republicans narrowly pass budget resolution proposing $880 billion in Medicaid cuts over the next decade, with President Trump's endorsement despite previous promises to protect the program.
• Robert F. Kennedy Jr. confirmed as HHS Secretary in a 52-48 Senate vote, raising concerns over his controversial vaccine stance and unclear Medicare/Medicaid strategy.
• Trump administration terminates multiple health advisory committees, removes clinical trial diversity guidance, and reverses Biden-era drug pricing initiatives in sweeping policy changes.
CMS Completes Second Round of Medicare Drug Price Negotiation Agreements with 15 Manufacturers
• CMS has secured agreements with all manufacturers of the 15 drugs selected for the second round of Medicare Drug Price Negotiation Program, with negotiated prices to be finalized by November 2025 and implemented January 2027.
• The selected drugs account for $40.7 billion in Medicare Part D expenditures (14% of gross spending) and affect approximately 5.3 million Medicare enrollees, following the first round which achieved price reductions of 38-79%.
• The program's future remains uncertain under the Trump administration, with Republican leadership signaling potential repeal efforts despite the program's progress and pharmaceutical companies already adjusting their strategies.
Study Reveals Major Disparities in US Health Plan Coverage of Pharmacogenetic Testing
• A comprehensive analysis of major US health insurers found significant variability in coverage policies for pharmacogenetic tests, with most plans covering 10 or fewer of 65 clinically relevant drug-gene pairs.
• Medicare's Molecular Diagnostic Services program provided the broadest coverage, including all 65 drug-gene pairs, while only three insurers covered multi-gene panel testing despite evidence of clinical benefits.
• Society guidelines were the most frequently cited evidence for coverage decisions, while cost-effectiveness studies were rarely considered, highlighting the need for standardized evidence evaluation processes.
China Medical System's MG-K10 Advances in Phase III Trials for Multiple Inflammatory Conditions
China Medical System's novel anti-IL-4Rα antibody MG-K10 has entered Phase III clinical trials for atopic dermatitis, asthma, and prurigo nodularis. The drug, which demonstrated promising efficacy and safety in Phase II trials, targets a global market expected to reach US$28.7 billion by 2030, addressing significant unmet needs in inflammatory disease treatment.
FDA Approves Alpha Cognition's ZUNVEYL® for Mild-to-Moderate Alzheimer's Disease
• The FDA has approved ZUNVEYL® (benzgalantamine), an oral therapy by Alpha Cognition, for treating mild-to-moderate Alzheimer's disease, marking a significant advancement in AD treatment.
• ZUNVEYL's dual mechanism of action is designed to minimize gastrointestinal drug absorption, potentially improving tolerability compared to existing Alzheimer's medications.
• Clinical trials demonstrated ZUNVEYL's bioequivalence and tolerability to galantamine, with minimal adverse events reported, offering sustained cognitive function improvements.
• ZUNVEYL is expected to be available nationwide by prescription in Q1 2025, providing a new option for Alzheimer's patients, families, and caregivers.
Sequana Medical's Alfapump Receives FDA Approval for Refractory Ascites Due to Liver Cirrhosis
• The FDA has approved Sequana Medical's Alfapump as the first active implantable device for recurrent or refractory ascites due to liver cirrhosis.
• The approval was based on the POSEIDON study, which demonstrated a significant reduction in the need for therapeutic paracentesis and improved quality of life.
• Sequana Medical plans to launch Alfapump in the US in H2 2025, targeting liver transplant centers with a specialized sales force.
• The US market opportunity for Alfapump is estimated at over $2 billion in 2025, driven by the increasing prevalence of NASH/MASH and alcoholic liver disease.
Humacyte's Bioengineered Vessel SYMVESS Receives FDA Approval for Extremity Vascular Trauma
• The FDA has approved SYMVESS, Humacyte's acellular tissue-engineered vessel, for treating extremity arterial injuries in adults when urgent revascularization is needed.
• SYMVESS offers a readily available alternative to autologous vein grafts, reducing surgical time and avoiding additional incisions in already-injured patients.
• Clinical trials showed high patency rates and low rates of amputation and infection, positioning SYMVESS as a promising option for vascular trauma care.
• SYMVESS has received Regenerative Medicine Advanced Therapy designation and priority review, highlighting its potential to address a significant unmet medical need.
FDA Approves Ryoncil, First Mesenchymal Stromal Cell Therapy for Pediatric Steroid-Refractory Acute Graft-versus-Host Disease
• The FDA has approved Ryoncil (remestemcel-L-rknd) as the first mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-versus-host disease (SR-aGVHD) in pediatric patients.
• Ryoncil's approval was based on a Phase III trial demonstrating a 70% overall response rate in children with SR-aGVHD after 28 days of treatment.
• This allogeneic, bone marrow-derived MSC therapy offers a new treatment option for children with SR-aGVHD who do not respond to steroid treatment.
• Ryoncil is administered intravenously and should be monitored for infusion reactions; common side effects include infections, fever, hemorrhage, and abdominal pain.
BioCardia's CardiAMP Heart Failure Trial Results to be Presented at ACC 2025
• BioCardia's CardiAMP HF Phase 3 trial results will be presented at the American College of Cardiology (ACC) 2025 Scientific Sessions.
• The CardiAMP cell therapy uses a patient's own marrow cells to stimulate the body's natural healing response in the heart.
• CMS has approved reimbursement for study procedures, potentially mitigating costs and accelerating the trial's progress.
• The FDA approved a protocol amendment, allowing for the inclusion of more patients in the CardiAMP HF II trial.
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