logo
US FDA declines to approve Capricor's muscle disorder therapy

US FDA declines to approve Capricor's muscle disorder therapy

Reuters6 days ago
July 11 (Reuters) - Capricor Therapeutics (CAPR.O), opens new tab said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy.
The FDA said it needed more data to prove the therapy is effective.
Shares of the San Diego-based company fell 33% premarket.
Cardiomyopathy, a condition that affects heart muscles, is the leading cause of death in patients with DMD, a genetic disorder characterized by progressive muscle degeneration and weakness.
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Does Medicare cover an air ambulance?​
Does Medicare cover an air ambulance?​

Medical News Today

timean hour ago

  • Medical News Today

Does Medicare cover an air ambulance?​

Medicare may cover air ambulance transportation if a person has a medical emergency and needs to get to a hospital from somewhere a ground ambulance cannot reach. Air ambulances are usually helicopters or small airplanes. Medicare coverage for emergency flightsOriginal Medicare Part B may cover an airplane or helicopter ambulance if a person needs immediate and fast transport that ground transportation cannot Part B pays for 80% of eligible costs once a person pays their deductible, which is $257 in 2025. People are responsible for the remaining 20% of must also pay the Part B monthly premium of $185. This amount may be higher, depending on someone's a person has a Medicare Advantage plan, it is subject to the same rules as Original Advantage copayments, coinsurance, deductibles, and premiums can vary by the plan type, provider, and to the Centers for Medicare & Medicaid Services (CMS), the average 2025 Medicare Advantage premium is around $17 per month in addition to the Part B premium that a person must pay directly to much does an air ambulance cost with Medicare?Out-of-pocket costs for transportation via an air ambulance can be to the National Association of Insurance Commissioners, one 52-mile air ambulance flight can cost between $12,000 and $25,000. The high costs come from:initial aircraft costs (which can be up to $6 million)on-board medical equipmentmaintenance 24/7 availability for specially trained medical personnel and pilotsHelp with air ambulance costsPeople with Original Medicare can sign up for a Medicare supplement plan (also called Medigap) that may help pay for some of Part B's out-of-pocket costs. Medigap plans have monthly premiums, which vary by plan and can also consider registering with the Life Flight Network, a private air ambulance service that might help with remaining out-of-pocket costs.A basic Life Flight Network air ambulance membership costs $85 per and other ambulance servicesMedicare Part B commonly covers ground ambulances in emergencies, particularly when other transport options are unavailable or may harm a person's may sometimes cover nonemergency transportation if a doctor or healthcare professional deems it medically necessary.»Learn More:What transport options does Medicare cover?

What should caregivers know about Medicare?
What should caregivers know about Medicare?

Medical News Today

timean hour ago

  • Medical News Today

What should caregivers know about Medicare?

When a person cares for someone eligible for Medicare, it's important to ensure they have the right permissions, information, and contact details to help manage their care Medicare's different coverage rules is important for caregivers, but there are also some other things to consider, such as enrollment periods, when to review coverage, and whether financial help may be before these things, it's essential a person has the right medical permissions to manage their loved one's care. This caregiver guide will help people navigate Medicare and provide some important contact the right Medicare permissionsMedicare cannot discuss anything with anyone other than the beneficiary unless they have the correct permissions. This includes discussing everything from medical information to claims and ensure a person has the right permissions, the beneficiary must complete the authorization to disclose personal health information release form, which is also available in Spanish.»Learn more:Becoming a healthcare power of enrollment periodsMedicare has various enrollment periods to become familiar enrollment periods are:initial enrollment period (IEP)open enrollment period (OEP)general enrollment period (GEP), also called Medicare Advantage open enrollment period (MA-OEP)special enrollment period (SEP)Initial enrollment period (IEP)Everyone eligible for Medicare has a 7-month initial enrollment period (IEP).During this time, they can enroll in Original Medicare, which includes Part A inpatient hospital coverage and Part B outpatient medical IEP:starts 3 months before a person's 65th birth monthcontinues throughout their 65th birth monthends 3 months after their 65th birth monthOpen enrollment period (OEP)Medicare's OEP runs between October 15 and December 7 each open enrollment, people can change their Medicare coverage. For example, they can:swap from Original Medicare to a Medicare Advantage planswap from Medicare Advantage to Original Medicareenroll in, leave, or switch Part D prescription drug planschange from one Medicare Advantage plan to anotherGeneral enrollment period (GEP)If people miss their IEP, they can enroll during the GEP, which runs between January 1 and March 31 each year. However, they may have to pay a late enrollment penalty unless they are eligible for a special enrollment a person already has a Medicare Advantage plan, they can change from one Medicare Advantage plan to another or leave a Medicare Advantage Plan and return to Original returning to Original Medicare, people can also choose to join a stand-alone Medicare Part D prescription drug plan to ensure their medications are enrollment period (SEP)If a person misses their IEP, they may be able to enroll during a special enrollment period or are several reasons a person may qualify for a SEP, including:having alternative coverage that is coming to an end, such as through an employerreturning to the United States after living abroadtheir plan's Medicare contract ending or changing»Learn more:Medicare enrollment to know plan documentsCaregivers can familiarize themselves with the Medicare & You handbook, which Medicare updates every handbook details general Medicare coverage rules, costs, plan rules, and any changes that affect coverage for the new calendar also find information on a person's rights, appeals processes, and where to get answers to common Medicare a person has a Medicare Advantage plan, caregivers should ensure that the private insurer administering the plan has sent the plan documentation, which details its own plan rules and the coverage options assistanceMedicare offers people and their caregivers educational help and support when navigating the healthcare support includes:Principle illness navigation services: This care management service helps people understand specific medical conditions and guides them through the healthcare system they care management services: This service covers condition-specific management for complex chronic conditions that may result in hospitalization, physical or cognitive decline, or end-of-life care management services: If a person has two or more chronic conditions that they expect to last for at least 1 year, Medicare may pay for a healthcare professional to help manage their care specifically for these care services: To try and avoid unnecessary tests, services, and medical errors, Medicare offers care coordination services to ensure medical information is shared across a person's healthcare team, including with the facilities involved in their care. This ensures it is the most effective care possible. Coordinated care services include: Accountable care organizations (ACOs) include doctors, healthcare professionals, hospitals, and healthcare facilities. They all accept Original Medicare and work together to coordinate a person's care. ACO Realizing Equity, Access, and Community Health (ACO REACH) helps different kinds of primary care doctors and specialists work together to improve healthcare quality and results under Original services may be available based on a person's exact needs. To find out more, caregivers can contact Medicare or the person's plan servicesBoth Original Medicare and Medicare Advantage plans offer many free preventive services. This includes services that do not require payment of out-of-pocket costs like deductibles, coinsurance, and list is comprehensive and may not include all available options, particularly if someone has a Medicare Advantage plan, as these plans typically include additional services that Original Medicare does not assistanceMedicare may be able to offer some help to those with low income and options may include:Medicare Savings Plans (MSPs): There are four different MSP types, each offering different savings. The programs are: Qualified Medicare Beneficiary (QMB) programSpecified Low-Income Medicare Beneficiary (SLMB) programQualifying Individual (QI) programQualified Disabled and Working Individual (QDWI) programExtra Help: This program helps people with the costs of their prescription Medicaid is a joint state and federal program that helps with healthcare costs. Some people may be dually eligible for both Medicare and Medicaid. Sometimes, Medicaid may cover some or all of the costs that Medicare does not local programs may also help with healthcare costs, so caregivers should always check with the beneficiary's local state department for informationCompiling a list of contacts can help caregivers know who to contact and when. They can start by compiling a list of their loved ones:family doctor or primary care doctornearest hospital, clinic, or other healthcare facilitynearest or preferred pharmacyOther important contacts include:Medicare800-633-4227 (TTY: 877-486-2048)Lines are open 24/7, except for some federal mailing addressMedicare Contact Center OperationsPO Box 1270Lawrence, KS 66044milConnect800-538-9552 (TTY: 866-363-2883)Alternatively, use this helpful web tool to find a local contact details are for members of the military and can help them identify military benefits and locate local military benefits Retirement Board (RRB)877-772-5772 (TTY: 312-751-4701)Automated services available 24/7Social Security Administration (SSA)register, enroll, and manage accounts via the SSA those unable to access online services: 800-772-1213 (TTY: 800-325-0778). Lines are open between 8 a.m. and 7 p.m. local time each Health Insurance Assistance Program (SHIP)877-839-2675This service offers tailor-made Medicare and other health insurance advice.U.S. Department of Veterans Affairs (VA)health benefits hotline: 877-222-8387Lines are open between 8 a.m. and 8 p.m. ET on can support Medicare beneficiaries in many ways, and it is vital to ensure they have all the information they need or know where to find the right permissions to manage Medicare on behalf of a beneficiary should be the first thing a caregiver does so that they don't experience any barriers when discussing about the different Medicare enrollment periods, coverage options, rules and procedures, and the financial help that may be available will ensure caregivers have everything they need to manage any Medicare plan.

Does Medicare cover cochlear implants​?
Does Medicare cover cochlear implants​?

Medical News Today

timean hour ago

  • Medical News Today

Does Medicare cover cochlear implants​?

Medicare can cover cochlear implants for those who meet the eligibility costs may vary depending on whether the procedure is inpatient or eligibility for cochlear implantsFor Medicare to pay for cochlear implants, a person must have:a diagnosis of bilateral moderate-to-profound sensorineural hearing impairment with limited benefit from standard hearing aidsthe ability to understand and participate in training and rehab after surgeryan accessible cochlear lumen, which is the fluid-filled area in the inner ear, that's suitable for implantationAlso, a person must not have:a middle ear infectiondamaged areas in the auditory nerve and sound areas of the central nervous systemother conditions that could prevent a safe surgeryWhat is the cochlear implant 60-60 rule?The 60-60 rule refers to specific standards a person must meet to qualify for cochlear first 60 refers to the pure-tone average (PTA). A healthcare professional can check whether someone's ear with less hearing loss has a PTA of 60 decibels of hearing level or second 60 refers to word recognition. On a hearing test, a person must have a word recognition score of 60% or someone meets these standards, they can qualify for cochlear implant costs with MedicareAccording to Medicare's 2025 national average data, the average cost of cochlear implantation surgery in a hospital outpatient department is $939. This cost includes doctors' fees and facility implantation procedures occur in ambulatory surgical centers, which are outpatient facilities. They have an average cost of $ both instances, Medicare Part B may typically cover the costs can include premiums, deductibles, copayments, and coinsurance. The standard 2025 monthly Part B premium is $185, and the deductible is $257. Once a person pays their deductible, they must typically pay a 20% a person experiences a hospital admittance, Medicare Part A may cover the costs of cochlear implants. Part A costs include a 2025 deductible of $1,676. After paying this, the first 60 days in the hospital are not subject to any other out-of-pocket expenses.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store