Why Hospitals Charge Private Insurance Companies More Than Medicare Advantage Plans

Differences Revealed: Why Hospitals Charge Private Insurance Companies More Than Medicare Advantage Plans

In the United States, paying for health care has always been a complicated and controversial subject. One of the most interesting things about this complicated system is that hospitals often charge private insurance companies more than they charge Medicare Advantage plans. This seems like a contradiction. Even though this is legal, it raises questions about fairness, openness, and the way the American healthcare system works. In this blog post, we’ll look into why this price difference exists and what it means for patients and the healthcare business as a whole.

Commercial insurance vs. Medicare Advantage: What’s the Difference?

Before we break down why prices are so different, it’s important to know who the main players are: private insurance companies and Medicare Advantage plans.

Commercial insurance companies are privately owned businesses that offer people and businesses different kinds of health insurance benefits. Most of the time, these plans come with a variety of coverage choices and price levels, which are usually worked out between the insurance company and the healthcare provider.

Medicare Advantage plans, on the other hand, are part of the federal Medicare program and are given by private insurance companies that have contracts with the government. These plans are an option to Original Medicare. They offer extra benefits and services, like coverage for dental and eye care, at a price that is often more predictable.

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Price Differences: What’s Going On

Negotiation Power: One of the main reasons for the price difference is that private insurance companies have more power to negotiate than Medicare Advantage plans. Most of the time, commercial insurers have more customers, which gives them an edge they can use to get better reimbursement rates from hospitals. This means that hospitals have to charge more to make up for the money they might lose from discounts they arrange.

1. Network Access: Hospitals may also charge business insurers more because these plans give them access to a larger network of doctors and hospitals. Most of the time, people with commercial insurance have a wider range of hospitals and doctors to choose from. In order to stay competitive and appealing to these patients, hospitals may charge business insurance companies higher rates to be in their networks.

2. Administrative Costs: Hospitals may have to pay more in administrative costs to process claims and handle contracts with private insurance companies. This is hard because you have to negotiate with a lot of different private insurance, each of which has its own rules. Medicare Advantage plans, on the other hand, have standard processes, which could lead to lower administrative costs.

3. Risk Profile: Commercial insurance plans usually cover a more diverse and possibly higher-risk group of people than Medicare Advantage plans, which are mostly for older people who qualify for Medicare. Due to the higher risk of private insurance plans, hospitals may have to charge higher rates to protect themselves from losses that could come from treating complicated and expensive cases.

4. Profit Motive: Because the American healthcare system is based on making money, hospitals may be tempted to charge private insurers higher rates to make as much money as possible. Medicare Advantage plans may have tighter rules and lower profit margins if they are overseen by the federal government.

What it means and what worries us?

The difference in price between private insurance and Medicare Advantage plans raises a number of issues and has a number of effects:

1. Health care costs for patients: Patients with private insurance may have to pay more because their fees, co-pays, and out-of-pocket costs have gone up. Due to money problems, this pricing system could make people less likely to get the medical care they need.

2. Affordability and Equity: The difference in prices shows that the healthcare system is not fair to everyone. It makes the gap bigger between people who can pay for full commercial insurance and people who have to depend on government-run plans. This makes me wonder if everyone has the same chance to get good health care.

3. Transparency: When hospital prices aren’t clear, it can be hard for people to figure out how much their medical care will really cost. Patients would be able to make better decisions about their health care choices if prices were more clear.

4. Incentives for Providers: The way prices are set now could give healthcare providers a reason to give patients with private insurance more attention than those with Medicare Advantage plans. This could hurt the standard of care given to patients and go against the idea that everyone should be treated the same.

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In the end…

The differences in prices between what hospitals charge private insurance companies and what they charge Medicare Advantage plans show how complicated the American health care system is. Even though negotiations, network access, and administrative problems have a lot to do with these differences, the main worry is still how they affect patients. To fix these problems, we need a complete plan that puts transparency, fair access to care, and effective regulation of pricing practices at the top of the list. As the talk about healthcare reform goes on, it’s important to understand how prices work so that we can all have a more fair and patient-centered healthcare system.


Are Medicare Advantage Plans Good?


Medicare is a government-sponsored health insurance program in the United States that provides coverage for individuals aged 65 and older, as well as certain younger individuals with disabilities. The program consists of several parts, each with its own coverage and benefits. Among these parts, Medicare Advantage plans have gained significant popularity and debate. In this blog post, we will explore how Medicare parts work, how Medicare Advantage plans function, and what other options individuals may consider. We will also discuss why someone would consider Medicare Advantage plans over Original Medicare accompanied by a Medigap or Medicare Supplement Insurance Plan.

Understanding Medicare Parts

To grasp the concept of Medicare Advantage plans, it’s essential to understand the different parts of Medicare. Here’s a brief overview:

  1. Medicare Part A (Hospital Insurance): Part A covers inpatient hospital stays, skilled nursing facility care, hospice care, and some home health care services. Most people do not pay a premium for Part A if they or their spouse paid Medicare taxes while working.
  2. Medicare Part B (Medical Insurance): Part B covers medical services such as doctor visits, outpatient care, preventive services, and durable medical equipment. It requires a monthly premium based on income and a yearly deductible.
  3. Medicare Part C (Medicare Advantage): Part C refers to Medicare Advantage plans, which are private health insurance alternatives to Original Medicare (Parts A and B). These plans must cover all services offered by Parts A and B and often include additional benefits like prescription drug coverage, dental, vision, and hearing services.
  4. Medicare Part D (Prescription Drug Coverage): Part D provides prescription drug coverage. It can be added to Original Medicare (Parts A and B) or obtained through a Medicare Advantage plan.
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How Medicare Advantage Plans Work

Medicare Advantage plans, also known as Part C, are offered by private insurance companies approved by Medicare. They combine the benefits of Parts A and B into a single plan while frequently including additional coverage. Here are some key features of Medicare Advantage plans:

  1. Coverage and Benefits: Medicare Advantage plans must provide the same coverage as Original Medicare (Parts A and B), but they can offer additional benefits like dental, vision, hearing, and fitness programs. Some plans also include prescription drug coverage (Part D).
  2. Networks and Referrals: Medicare Advantage plans typically have provider networks, and individuals may need to choose healthcare providers within those networks. In most cases, referrals from a primary care physician are required for specialized care.
  3. Cost Structure: Medicare Advantage plans usually have a monthly premium in addition to the Part B premium. They may also involve copayments or coinsurance for services. However, these out-of-pocket costs are often capped, providing financial protection.
  4. Managed Care Approach: Medicare Advantage plans often operate under a managed care model, such as Health Maintenance Organizations (HMOs) or Preferred Provider Organizations (PPOs). HMOs typically require individuals to receive care within the plan’s network, while PPOs offer more flexibility but may have higher costs.

Considering Other Options

While Medicare Advantage plans offer several advantages, they may not be the best fit for everyone. Here are a few alternatives individuals may consider:

  1. Original Medicare (Parts A and B): Some individuals prefer to stick with Original Medicare and supplement it with separate Part D prescription drug coverage and Medigap (Medicare Supplement Insurance) to help cover out-of-pocket costs.
  2. Medicare Supplement Insurance (Medigap): Medigap policies are sold by private insurance companies and can help pay for certain costs not covered by Original Medicare, such as copayments, coinsurance, and deductibles. Medigap plans work alongside Original Medicare and do not provide additional benefits.
  3. Programs for Low-Income Individuals: Medicaid is a joint federal and state program that provides health coverage to low-income individuals. It may be an option for individuals with limited financial resources.
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Why Consider Medicare Advantage Plans with Medigap or Medicare Supplement Insurance?

While Original Medicare supplemented with Medigap or Medicare Supplement Insurance is a popular choice, there are instances where Medicare Advantage plans might be a better option. Here are a few examples:

  1. Desire for Convenience: Medicare Advantage plans often consolidate coverage into a single plan, including prescription drugs and additional benefits. This simplicity can be appealing to individuals who prefer a one-stop solution.
  2. Financial Considerations: Medicare Advantage plans frequently have a cap on out-of-pocket costs, providing financial predictability and protection. This can be advantageous for individuals who want to limit their potential healthcare expenses.
  3. Preference for Managed Care: Some individuals prefer the managed care approach of Medicare Advantage plans, which may involve primary care physicians coordinating their healthcare and offering a more comprehensive approach to managing their well-being.
  4. Additional Benefits: Medicare Advantage plans often include extra benefits like dental, vision, hearing, and wellness programs. These additional services can be attractive to individuals who want more comprehensive coverage.

In closing, Medicare Advantage plans can be a good option for individuals seeking simplified coverage, capped out-of-pocket costs, and additional benefits beyond what Original Medicare provides. However, it’s crucial to carefully assess individual healthcare needs and preferences before making a decision. Exploring alternatives like Original Medicare with Medigap or Medicare Supplement Insurance is also worth considering to ensure the best fit for one’s specific circumstances.

How safe are statins for older men?


Statins are a type of medication used to decrease cholesterol levels. They are one of the most often prescribed medications worldwide, and are frequently used to prevent heart disease. The use of statins in older men who have never been diagnosed with heart disease, on the other hand, is debatable.

There is limited evidence that statins can help elderly men who have never been diagnosed with heart disease. A research published in the Journal of the American Medical Association, for example, discovered that statin therapy cut the risk of mortality from heart disease by 25% in males over the age of 70. Other studies, however, have suggested that statins may be less helpful in preventing heart disease in older men, and may even raise the risk of side effects including muscle discomfort and cognitive issues.

The decision to take a statin or not is a personal one that should be taken after considering the risks and benefits with your doctor. If you are an older man who has never been diagnosed with heart disease, you should consult with your doctor to determine whether statin therapy is appropriate for you.

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Here are some things to think about before making your decision:

  • Your chances of getting heart disease.
  • Your age.
  • Your general well-being.
  • Your family history of cardiovascular disease.
  • Any additional medications you are currently taking.
  • Statins’ possible adverse effects.

If you decide to take a statin, make sure to follow your doctor’s instructions. Your cholesterol levels should also be monitored on a regular basis to ensure that the medicine is effective.

Here are some heart-healthy lifestyle suggestions:

  • Maintain a nutritious diet.
  • Exercise on a regular basis.
  • Keep a healthy weight.
  • Stop smoking and/or vaping.
  • Limit your alcohol consumption.
  • Manage your stress.

Following these guidelines will help minimize your chance of getting heart disease whether or not you take a statin.

Inflation Reduction Act and Medicare Prescription Drugs

 

On Aug. 12, the Inflation Reduction Act of 2022 (IRA) passed the U.S. House by a vote of 220-207, and President Biden is expected to sign it into law. First passed by the U.S. Senate on Aug. 7, the $740 billion budget reconciliation package includes policies on Medicare drug pricing, Affordable Care Act (ACA) subsidies, energy, climate, and taxes. This update provides high-level details on the notable health care-related provisions in the IRA.

Allowing Medicare to Negotiate Drug Prices

With the goal of improving affordability for high-priced drugs in Medicare Parts B and D, the IRA directs the Department of Health and Human Services (HHS) to establish a drug price negotiation program for certain high-priced, single-source drugs and biological products. Under this program, the HHS Secretary will publish a list of selected drugs that meet certain criteria, then negotiate (and renegotiate as needed) maximum fair prices with manufacturers of those drugs. Drugs eligible for negotiation include the 50 Part B and 50 Part D single-source drugs with the highest total expenditures during the most recent 12-month period; however, negotiation is limited to Part D drugs for 2026 and 2027. Negotiated prices must take effect for 10 eligible drugs in 2026, increasing to 20 drugs in 2029. For 2026, the expenditure period to be reviewed is June 1, 2022 through May 31, 2023, and the selected drug list publication date will be Sept. 1, 2023.

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Redesigning the Medicare Part D Program, Including Capping Annual Out-of-Pocket Costs for Beneficiaries

The IRA significantly reforms the Medicare Part D benefit design, including capping maximum out-of-pocket (OOP) costs at $2,000 annually, with a copay smoothing component; capping annual premium growth at 6%; and expanding eligibility in the Low-Income Subsidy (LIS) program.

  • Beneficiary Cost-Sharing Changes:
  • Beginning in 2024, beneficiaries will be responsible for $0 in the catastrophic benefit phase. There are no changes to the initial coverage phase or coverage gap phase.
  • Beginning in 2025, the coverage gap phase will be eliminated, and a new $2,000 OOP cap will be applicable with the option to spread OOP payments out over the course of the year. The initial coverage phase remains unchanged.
  • Part D Benefit Design: The bill restructures plan, manufacturer, and federal government liabilities for the different benefit phases beginning in 2025:

Initial Phase

  • Beneficiary: 25%
  • Plan: 65% for brands, 75% for generics
  • Manufacturer: 10% for brands, 0% for generics

Catastrophic Phase

  • Beneficiary: 0%
  • Plan: 60%
  • Manufacturer: 20% for brands, 0% for generics
  • Federal Government: 20% for brands, 40% for generics
  • Premium Stabilization: For 2024 through 2029, any increase in the Part D base beneficiary premium is limited to the lesser of a 6% increase from the previous year or the premium that would have been applied if the stabilization program was not established. In 2030 and subsequent years, the HHS Secretary is authorized to make adjustments necessary to the base Part D premium to ensure that premium is increased by the lesser of 6% or what the premium would have been if the stabilization program was not established.
  • Expanded LIS Eligibility: The bill expands eligibility for the Part D LIS program from 135% of the federal poverty level to 150% beginning in 2024.
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Capping Insulin Cost-Sharing in Medicare

For 2023 through 2025, the bill caps beneficiary cost-sharing at $35 a month for Medicare Part D or Medicare Advantage Prescription Drug Plan (MA-PD) covered insulin products. In 2026 and beyond, it caps cost-sharing at the lesser of $35 or 25% of the maximum fair price or 25% of the plan’s negotiated price. The cost-sharing is capped regardless of where the beneficiary is in the benefit phase, and Part D and MA-PD plans are eligible for a retroactive subsidy in 2023 equal to the aggregate reduction in cost-sharing and deductible due to implementing this provision.

Implementing Drug Manufacturer Inflationary Rebates in Medicare

The legislation requires drug manufacturers to pay rebates to the government if drug prices in Medicare Part B and Part D rise faster than inflation, with rebates equaling the rate at which the price of the drug exceeds inflation. This rebate provision goes into effect Jan. 1, 2023 for Part B rebatable drugs and Oct. 1, 2022 for Part D rebatable drugs. Drugs with an average cost of less than $100 are excluded. Additionally, HHS is instructed to reduce or waive the rebate amount for a Part D rebatable drug if it is on the drug shortage list, per the Federal Food, Drug, and Cosmetic Act.

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Requiring Vaccine Coverage in Medicare Part D

Beginning in 2023, Part D plans are required to cover all adult vaccines recommended by the Advisory Committee on Immunization Practices, without cost-sharing or the application of a deductible (other than vaccines covered under Part B). Part D and MA-PD plans are eligible for a retroactive subsidy in 2023 equal to the aggregate reduction in cost-sharing and deductible due to implementing this provision.

Extended Delay of the Medicare Part D Rebate Rule

The legislation includes an additional five-year delay of the implementation of a rule that would prohibit manufacturer rebates in Part D, to Jan. 1, 2032.

Extending Enhanced ACA Subsidies Through 2025

Originally set to expire at the end of this year, the IRA extends the enhanced American Rescue Plan Act (ARPA) ACA premium tax credit subsidies through 2025.

911 emergency medical system in US ‘at a breaking point,’ ambulance group says

911 emergency medical system in US 'at a breaking point,' ambulance group says

With the Covid-19 surge straining America’s health care system, the 911 emergency call system has been stretched to “the breaking point,” the American Ambulance Association says.

Ambulance services are critical in getting sick patients to hospitals for care, and the American Ambulance Association, which represents all of the nation’s ambulance services, said they are struggling to stay together.
 
Hospitalizations have reached an all-time high with more than 100,200 admissions, according to the COVID Tracking Project. And more than 3,100 deaths were reported Wednesday, according to Johns Hopkins University.
 
Hospitals stretched beyond 'reasonable limit' as number of Covid-19 patients reaches 100,000 and reported deaths hit all-time high

 
“The 911 emergency medical system throughout the United States is at a breaking point,” Aarron Reinert, the president of the American Ambulance Association, said in a recent letter to the Department of Health and Human Services. “Without additional relief, it seems likely to break, even as we enter the third surge of the virus in the Mid-West and West.”
 

“Similar to hospitals and many skilled nursing facilities, ground ambulance service providers and suppliers since March have been serving their communities in a disproportionate manner to their traditional role in the Medicare program,” Reinert wrote in the letter.
 
“Given the substantially heavier burden that AAA members are carrying during the pandemic, we reiterate our request for HHS to provide additional funding from the Congressionally allocated dollars for the Provider Relief Fund specifically to ground ambulance service providers to ensure the stability of these essential providers and suppliers as the country continues to battle the pandemic,” he said.
 
An Alabama woman is raising 12 kids after her sister and brother-in-law died from Covid-19

 
The trade group is asking for $2.6 billion from HHS to prevent the emergency medical system from buckling under the weight of the pandemic.
 
The organization’s CEO Maria Bianchi told CNN the money would mean every single ambulance in the US, regardless of affiliation, would get $43,500 to help with supplies, such as personal protective equipment, and continued operations.
 
Bianchi described the current situation with ambulance services as a “rubber band stretched to the breaking point.”
 
“What is happening is you’re seeing services stretched and stretched and stretched and stretched, like a rubber band, and we’re still being pulled,” she said. “I think the concern is that rubber band breaking and that we’re close to that point.”
 
The US has just under 60,000 ambulances, Bianchi said, and the American Ambulance Association represents all of them

“It has never been this bad and we are looking for a tonic, something that can help us to alleviate this surge, so that that does not happen, so that someone doesn’t call 911 and a unit doesn’t arrive within the appropriate amount of time to help that person,” she said.

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Why are telehealth companies treating healthcare like the gig economy?

Why are telehealth companies treating healthcare like the gig economy?

Telehealth has taken off.

Spurred by the pandemic, many doctors in the U.S. now offer online appointments, and many patients are familiar with getting live medical advice over the internet. Given the obvious benefits, many experts have concluded that telehealth is here to stay. “It’s taken this crisis to push us to a new frontier,” said Seema Verma, administrator of the Center for Medicare and Medicaid Services. “But there’s absolutely no going back.”

Now the question is, where are we going? Telehealth has played an essential role during the pandemic, and it could do even more good in the years to come. But we are still in the very early days of its development. And if we are to realize telehealth’s full potential, then we must first reckon with the fact that there are serious flaws in the predominant way it is delivered today– flaws that endanger patients themselves.

Legacy telehealth services like Teladoc and others were built for a time when telehealth was a fringe phenomenon, mostly used to support acute needs like a bad cold or a troubling rash. They largely offer, in effect, randomized triage care. Patients go online, wait in a queue and see the first doctor who happens to be available. These companies market this as a virtual house call, but for patients, the experience may feel more like being stuck on a conveyer belt. Too often, they get funneled through they system with little to no choice along the way.

Insurance companies love this model because it is cheap to operate. But patients bear the cost. Doctors, in this arrangement, get paid to work the assembly line. Every minute they spend listening to patients– learning about their lives, building a personal relationship– is a minute they’re not moving them down the line, seeing the next patient and earning their next fee. The system doesn’t reward doctors for providing care; it rewards them for churning through patients.

As we build telehealth’s future, doubling down on this model would be a worrisome mistake since it is antithetical to how our healthcare system should operate. Healthcare has long been premised on the idea that you should have an ongoing relationship with your local care provider– someone with a holistic, longitudinal view of your health, who you trust to help navigate difficult or sensitive medical issues.

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The randomized triage model breaks this bond and replaces it with a series of impersonal interactions that feel more like the ones you have with an Uber driver– polite but transactional, brief and ephemeral. Healthcare, however, should not be treated in the same way as the gig economy.

As a physician, I am troubled by the prospect of what happens when you scale this model up. Every time a patient gets passed from one doctor to the next, there is a chance that critical information is lost. They won’t understand your baseline mood, your family context or living situation– all critical “intangibles” for informed treatment. That lack of longitudinal data leads to worse outcomes. This is why the healthcare system has long been designed to minimize patient handoffs– and why it would be a mistake for us to choose a telehealth infrastructure that increases them.

What, then, does a better approach look like?

We are at the very dawn of telehealth’s integration into our country’s healthcare system, and I won’t claim to know the full answer. But I do know that patients are far better stewards of their own health than a random doctor generator. A more effective approach to telehealth puts the power in the patients’ hands. Because when we give them choices and then listen to them, patients tell us what they prefer.

Data gathered by my company makes it clear that by a substantial margin, people want to make this decision themselves: 9 out of 10 telehealth patients prefer to schedule an appointment with a provider of their choosing rather than seeing a randomly assigned doctor after waiting in a digital queue.

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Not only that: when given this choice, most patients– about 7 out of 10– make an appointment with a nearby doctor when booking a virtual visit. Patients instinctively know that at some point, they’ll want or need to physically be in the same room with their doctor. And they know that choosing a local provider makes it possible to pick up the conversation in-person right where they left it off online. They don’t want to be forced to choose between telehealth and an ongoing relationship with a trusted provider. And they’re right– they shouldn’t have to.

None of the legacy telehealth companies focus on this imperative. Instead, while the pandemic rages on, they are rushing to scale while their randomized triage model is still viable. And the markets may reward them in the near term for being in the right place at the right time. But long-term value will be derived from listening to, responding to and iterating on what patients want.

Experience suggests patients will reward whoever can give them the most control over their healthcare. That’s where I’m placing my bet, too.

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Hospitals can care for Medicare patients at home in pandemic

Hospitals will be allowed to care for Medicare patients in their own homes during the pandemic under a new program announced Wednesday to help hospitals deal with the latest surge.

Some hospitals already offered patients with private insurance the choice of getting care at home instead of in the hospital. The pandemic dramatically boosted use of such programs.

The Centers for Medicare and Medicaid Services said it will let hospitals quickly launch home programs, which will offer around-the-clock electronic monitoring for Medicare and Medicare Advantage patients who are sick enough to be hospitalized, but don’t need intensive care.

COVID-19 patients are eligible. Six health systems already offering “hospital-at-home” care were approved to participate in the Medicare program immediately.

“We’re at a new level of crisis response with COVID-19” and this option will help hospitals increase their capacity to help more patients, CMS Administrator Seema Verma said in a statement.

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Hospitals would need to meet certain standards to participate. Those include providing twice-daily visits by medical workers and equipment such as blood pressure and oxygen-level monitors, and keeping patients connected via an iPad or other device to a command center should they need help. Medicare would pay hospitals the same rate as for in-hospital care.

Earlier in the pandemic, CMS expanded coverage for telemedicine appointments and launched a program paying for care in field hospitals and hotels.

“This will help health systems create capacity to care for patients during the surge,” said Dr. Bruce Leff, a geriatrics professor at Johns Hopkins School of Medicine and a home hospital pioneer. 

He said hospital-at-home programs have proven benefits for patients and can prevent complications they might experience in a hospital. 

Leff helped CMS plan the program, along with experts at major hospitals already running such programs and three companies that contract with hospitals to run programs for them: Medically Home, Contessa Health and Dispatch Health.

Since the pandemic began, all three companies have reported a surge of new, privately insured patients choosing to stay at home, where they can be more comfortable and have family around. 

Medically Home Chief Executive Rami Karjian said he hopes elderly patients who might defer care during the pandemic “will now get the care they need.”

 

What do you think about receiving at-home care instead of checking in for care at a hospital? Are you for or against this program? Would you try it?

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First blood test to help diagnose Alzheimer’s goes on sale

First blood test to help diagnose Alzheimer's goes on sale

A company has started selling the first blood test to help diagnose Alzheimer’s disease, a leap for the field that could make it easier for people to learn whether they have dementia. It also raises concerns about the accuracy and impact of such life-altering news.

Independent experts are leery because key test results have not been published and the test has not been approved by the U.S. Food and Drug Administration– it’s being sold under more general rules for commercial labs. But they agree that a simple test that can be done in a doctor’s office has been long needed.

It might have spared Tammy Maida a decade of futile trips to doctors who chalked up her symptoms to depression, anxiety, or menopause before a $5,000 brain scan last year finally showed she had Alzheimer’s.

“I now have an answer,” said the 63-year-old former nurse from San Jose, California.

If a blood test had been available, “I might have been afraid of the results” but would have “jumped on that” to find out, she said.

More than 5 million people in the United States and millions more around the world have Alzheimer’s, the most common form of dementia. To be diagnosed with it, people must have symptoms such as memory loss plus evidence of a buildup of a protein called beta-amyloid in the brain.

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The best way now to measure the protein is a costly PET brain scan that usually is not covered by insurance. That means most people don’t get one and are left wondering if their problems are due to normal aging, Alzheimer’s or something else. 

The blood test from C2N Diagnostics of St. Louis aims to fill that gap. The company’s founders include Drs. David Holtzman and Randall Bateman of Washington University School of Medicine, who headed research that led to the test and are included on a patent that the St. Louis university licensed to C2N.

About the test

The test is not intended for general screening or for people without symptoms– it’s aimed at people 60 and older who are having thinking problems and are being evaluated for Alzheimer’s. It’s not covered by insurance or Medicare; the company charges $1,250 and offers discounts based on income. Only doctors can order the test and results come within 10 days. It’s sold in all but a few states in the U.S. and just was cleared for sale in Europe.

It measures two types of amyloid particles plus various forms of a protein that reveal whether someone has a gene that raises risk for the disease. These factors are combined in a formula that includes age, and patients are given a score suggesting low, medium, or high likelihood of having amyloid buildup in the brain.

If the test puts them in the low category, “it’s a strong reason to look for other things,” besides Alzheimer’s, Bateman said.

“There are a thousand things that can cause someone to be cognitively impaired,” from vitamin deficiencies to medications, Holtzman said.

“I don’t think this is any different that the testing we do now” except it’s from a blood test rather than a brain scan, he said. “And those are not 100% accurate either.”

Accuracy claims

The company has not published any data on the test’s accuracy, although the doctors have published on the amyloid research leading to the test. Company promotional materials cite results comparing the test to PET brain scans— the current gold standard– in 686 people, ages 60-91, with cognitive impairment or dementia.

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If a PET scan showed amyloid buildup, the blood test also gave a high probability of that in 92% of cases and missed 8% of them, said the company’s chief executive, Dr. Joel Braunstein.

If the PET scan negative, the blood test ruled out amyloid buildup 77% of the time. The other 23% got a positive test result, but that doesn’t necessarily mean the blood test was incorrect, Braunstein said. The published research suggests it may detect amyloid buildup before it’s evident on scans.

Braunstein said the company wills eek FDA approval and the agency has given it a designation that can speed review. He said study results would be published, and he defended the decision to start selling the test now. “Should we be holding that technology back when it could have a big impact on patient care?” he asked.

What others say

Dr. Eliezer Masliah, neuroscience chief at the U.S. National Institute on Aging, said the government funded some of the work leading to the test as well as other kinds of blood tests.

“I would be cautious about interpreting any of these things,” he said of the company’s claims. “We’re encouraged, we’re interested, we’re funding this work but we want to see results.”

Heather Snyder of the Alzheimer’s Association said it won’t endorse a test without FDA approval. The test also needs to be studied in larger and diverse populations.

“It’s not quite clear how accurate or generalizable the results are,” she said.

 

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The world’s now scrambling for dry ice. It’s just one headache in getting coronavirus vaccines where they need to go

 

Vaccines like to be kept cool, none more so than the Pfizer candidate for Covid-19, which has to be deep-frozen. And that’s going to be an issue for developing countries — and for rural areas in the developed world.

The “cold rain” is just one of the challenges in distributing vaccines worldwide.

There are plenty of others: decisions about priority populations and databases to keep track of who’s received what vaccine, where and when. Additionally, different vaccines may have more or less efficacy with different population groups; and governments will need PR campaigns to persuade people that vaccines are safe.

But the logistics of transporting and storing vaccines– getting them from the factory gate to the patient’s arm– are critical. And as most vaccines are likely to require two doses, the whole chain needs must be repeated within weeks. 

Unique challenges 

The Pfizer-BioNTech vaccine needs to be kept at around -70 degrees Celsius (-94 degrees Fahrenheit) while it’s transported. That’s 50 degrees Celsius colder than any other vaccine currently used.

Moderna says its vaccine can be kept in freezers typically available in pharmacies, and in a refrigerator for up to 30 days. But there are likely to be fewer doses of the Moderna vaccine than of the Pfizer’s available over the next year.

Phase 3 trials have shown both vaccines to be around 95% effective but the results haven’t yet been reviewed by regulators.

On Wednesday, the CEO of BioNTech, the German biotech company partnering with Pfizer, acknowledged the issue of temperature control.

The world's now scrambling for dry ice. It's just one headache in getting coronavirus vaccines where they need to go

Employees fill a clinical and pharmaceutical product shipping box with dry ice at the Va-Q-Tec AG factory in Wurzburg, Germany, on Wednesday, Nov. 18, 2020. 

“We are working on formulation which could allow us to ship the vaccine even maybe at room temperature,” Ugur Sahin told CNN. “We believe that in the second half of 2021 we will have come up with a formulation which is comparable to any other type of vaccine.”

But in the meantime US Health and Human Services Secretary Alex Azar believes the Moderna candidate is “more flexible” for settings like a local pharmacist. Pfiszer’s, he said Monday, would be better suited to “big institutional vaccination, say a while hospital setting, several nursing homes at once.”

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Pfizer plans to ship up to 1.3 billion doses next year, requiring a lot of dry ice (carbon dioxide in solic form at around -78 degrees Celsius), and a lot of isothermic boxes. The boxes will hold up to 95 vials (4,875 doses) and be refilled with dry ice for up to 15 days of storage.

Pfizer is testing the supply chain in four US states. Its CEO, Albert Bourla, said Wednesday he has “zero concerns” about the cold chain requirements.

But shipping such a vaccine can pose big challenges. Dr. Jarbas Barbosa, assistant director of the Pan American Health Organization, told CNN that “the rural and the urban areas in any country in the world are not ready to manage this vaccine today.”

“So, who is prepared in the world? No one.”

One issuee is the availability of dry ice.

The Compressed Gas Association says carbon dioxide production capacity in the US and Canada is about 30,000 tons a day and is confident its members can meet demand for dry ice. It says that vaccine supply-chain officials believe less than 5% of dry ice production will be needed to support ultra-cold storage of Covid-19 vaccines in the United States and Canada.

Others in the industry expect bottlenecks. Several dry ice producers in the US told CNN they’ve already had offers for their entire output. Buddy Collen at Reliant and Pacific Dry Ice told online publication GasWorld: “We are in scramble mode trying to manipulate our production plants.”

Sam Rushing, president of Florida-based Advanced Cryogenics, told CNN there are already regional shortages in the US.

The main problem, Rushing says, is fewer vehicles on the road during the pandemic, meaning lower production of ethanol, from which carbon dioxide is a byproduct. European ethanol production has also fallen sharply this year.

US officials are confident enough dry ice will be available. Paul Ostrowski, director of supply, production, and distribution of Operation Warp Speed, told CNN last week that courier UPS had pledged to “provide dry ice replenishments throughout all of America upon demand.”

But Rushing cautions that dry ice is not very user-friendly and can be hazardous if stored improperly, especially in a confined space. The Federal Aviation Administration classifies it as hazardous cargo.

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Peter Gerber, CEO of Lufthansa Cargo, told CNN that the need for dry ice “clearly reduces also the transport capacity because if you have to load more ice you can’t load so much vaccine. And of course the procedures have to be very special in order to ensure that it always has this degree of coldness.”

US courier DHL is adapting distribution plans according to each vaccine’s specifications. David Goldberg, CEO of Global Forwarding US for the company, says “there is a restriction on the amount of dry ice used on an aircraft– typically 500-1,000 kilos depending on a number of factors.”

Once they arrive, Pfizer vials can be stored at between 2 and 8 degrees Celsius for up to five days before deteriorating. Pfizer says it has developed a “just-in-time system which will ship the frozen vials direct to the point of vaccination.” It will also monitor the temperature of every box being shipped.

Julie Swann, an expert in supply chains at North Carolina State University, says that large hospital systems, which often have ultra-cool freezers, may have a role as distribution hubs. But not all US states have them; Hawaii said last week none of its hospitals has such freezers.

Breaking down shipments of a frozen vaccine for rural areas or small groups of essential workers– without compromising their temperature– will be another headache, Swann said.

When a vaccine needs to be used with a few days, providers will need to ensure they are ready. “You can’t just wait to see who shows up,” Swann told CNN. “And we don’t really have good data yet defining where and who the priority populations are.”

The more links in the supply chain, the more risk that the vaccine’s temperature will be compromised. Last month the US Centers for Disease Control and Prevention advised states they should “limit transport of frozen of ultra-cold vaccine products.”

Prashant Yadav, a supply chain expert and senior fellow at the Center for Global Development said: “It’s a question of how soon can we start thinking about multiple packaging formats.”

Beyond the US

If getting a frozen vaccine to tens of millions of people is a challenge in the US, it’s a far greater problem for poorer countries.

Transport links are slower and medical facilities less equipped in the developing world. CO2 production is scarce, and the cost and hazards of shipping huge amounts of dry ice are also a hurdle, Yadav says.

David Gitlin, the CEO of refrigeration specialists Carrier, told CNN last week: “When you look at places like Africa and India, they just don’t have the cold chain infrastructure. The Untied State spends 300 times more per capita on cold chain than India.”

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Peru is one of many countries that have order the Pfizer vaccine. In the capital, Lime, where large volumes can be administered quickly, it should be effective, says Dr. German Malaga, one of a team working on Peru’s vaccine options. But while there are probably 30 ultra-cold freezers in Lima “for the other 20 million Peruvians including in the Andes and the rainforest there are none.”

“For the rest of the country we could use vaccines like the Chinese one that requires from 2 to 8 degrees is more manageable,” Malaga said.

“It’s about cost-effectiveness, which is not just about the vaccine but the whole process of vaccinating,” said Yadav. But if Pfizer’s candidates proves to be the most effective, demand for ultra-cold freezers would be overwhelming. 

Barbosa says the Pan American Health Organization is urging member states not to spend huge sums on preparing for one vaccine but join a multilateral facility called COVAX– essentially a clearing house for buying vaccines run by the World Health Organization.

Beyond the cold chain, there are other logistical hurdles. 

A massive airlift will be required to get vaccines where they need to go. Pfizer, which has production lines in Europe and the US, says it expects an average of 20 daily cargo flights worldwide.

DHL expects that 15 million cooling boxes will need to be delivered on 15,000 flights over the next two years. David Goldberg told CNN the company has established a high quality cold-chain network and is adding flights between China, Europe and the US.

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Many countries can call on existing programs as models. Peru’s national vaccination program reaches about 75% of its population, Malaga said.

India’s polo vaccination program is ubiquitous– covering more than 90% of children by this year, according to Gagandeep Kang of the Wellcome Trust Research Laboratory at the Christian Medical College in Vellore.

“For polio programs, we have used boats and mules and enterprising health staff,” said Kang. But such programs are designed for less than a tenth of the population, and Covid-19 vaccines will need to focus on different groups, she said.

India will need “a series of waves each addressing a different group as vaccines become available,” she told CNN.

“We will need to see performance characteristics of other vaccines, and their delivery requirements before making a call on what to go with,” said Kang, who is also a member of the World Health Organization’s Global Advisory Committee on Vaccine Safety.

In such a dynamic situation, record-keeping becomes critical. Dr. Anna Blakney, who is working on a vaccine being developed by Imperial College London, said there is no centralized infrastructure in the US for monitoring who is getting what and when, which she describes as a “really critical issue.”

Yadav says that even when the vaccine reaches its destination there will need to be some flexibility to allow people to get their second dose in a different location if desired. And that demands reliable databases.

Barbosa said that beyond the supply chain, governments “must have a good communications strategy to overcome public skepticism and conspiracy theories about vaccines.”

Blakney agrees. “The process [of vaccine development] has been so fast that it’s not surprising people are skeptical as they read about safety and possible side-effects,” she said. Blakney is part of an international effort launched by research scientists to reassure people via social media about the safety and efficacy of Covid-19 vaccines.

Finding enough dry ice is just one in a sequence of challenges to get the world vaccinated against Covid-19.

 

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Medicare’s ‘Part B’ outpatient premium to rise by $3.90

 

Medicare’s ‘Part B’ outpatient premium to rise by $3.90

Medicare’s ‘Part B’ monthly premium for outpatient care will go up by $3.90 next year to $148.50, officials announced late Friday afternoon. 

For most retirees, the health care cost increase will claim a significant slice of their Social Security cost-of-living adjustment, or COLA. It works out to nearly 20% of the average retired worker’s COLA of $20 a month next year.

The bite could have been deeper. It was feared that emergency actions the government took to stabilize the health care system in the coronavirus pandemic could have triggered lare premium increases. That prompted Congress to pass bipartisan legislation that limited the increase for 2021 but would gradually collect the full amount later under a repayment mechanism. 

The Part B premium is set by law to cover about 25% of the cost of Medicare’s supplemental insurance for outpatient services. Inpatient care is covered by Medicare’s ‘Part A,’ which is financed with payroll taxes from workers and employers. 

Medicare also announced that the Part B deductible next year will be $203, an increase of $5. The deductible is the amount patients pay each year before their insurance kicks in. 

The inpatient deductible will be $1,484, an increase of $76.

Most Medicare recipients rely on supplemental insurance or a Medicare Advantage plan to cover their annual deductibles. 

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