Auxo Medical News

As of February 3, 2022, accessories for non-FDA approved automated external defibrillators (AEDs) and professional defibrillators, “must no longer be supported by manufacturers,” according to the U.S. Food and Drug Administration (FDA). 

The FDA informed the manufacturers, distributors, owners, users and prescribers of all AEDs and defibrillators about this update.  

For a unit to be considered non-FDA approved, that means the manufacturer failed to file for a premarket approval application (PMA) prior to the modified deadline of February 3, 2022. The revised compliance policy deadline was intended to give facilities additional time, especially during the coronavirus pandemic, to acquire FDA-approved AEDs, and for manufacturers to file the necessary PMA for accessories. 

In the United States, more than 95% of all confirmed COVID-19 cases are believed to be the variant known as Omicron.

According to the CDC, the accelerated rate of growth in Omicron infections is considered to be a result of multiple factors — the variant’s elevated transmissibility as well as its power to evade immunity by way of a previous infection or vaccination.

So where do all of these insights and data come from? They’re the result of invaluable efforts taking place ‘behind the scenes’ through the process of tracking information on the virus.

Collecting & Analyzing Information

Gathering data to track COVID-19 cases is a fluid, collaborative process that has evolved over the course of this global coronavirus pandemic.

One example of tracking efforts underway is between Walgreens and their lab-testing partner, Aegis Sciences. The company has developed a novel tracking tool that pin-points, in real time, the extent of existing and emerging variants. This 95% statistic of the Omicron variant mentioned above is based on data procured and monitored from the national retain chain and pharmacy, by way of positive test results among their thousands of locations.

Starting on January 1, 2022, a new law came into effect that should be a breath of fresh air for insured families all over the United States — no more surprise medical bills. This law applies to patients receiving medical care in emergency rooms as well as other health services such as nonelective emergency cases and air ambulances. 

With bipartisan support, the No Surprises Act was passed by Congress last December. The law puts into motion, with federal protection, no surprise medical bills for consum-ers. 

What constitutes a “surprise” medical bill? 

For starters, it’s important to understand what type of medical bills are protected by this new law, how patients’ wallets are shielded, and if there are any financial implications when it comes to medical care costs and premiums. 

Healthline Media interviewed policy experts to help answer these questions. 

Research professor emeritus in the Health Policy Institute of Georgetown University’s School of Public Policy, Jack Hoadley, PhD, explained, “This is important because there are numerous situations that can be surprising but don’t fall into this official bucket of surprise medical bills.” Hoadley continued, “When we talk about surprise medical bills for the purposes of the No Surprises Act, it means situations where you end up using an out-of-network healthcare facility or healthcare provider, generally, through no fault of your own.” 

For example, some circumstances include not realizing that your insurance coverage requires a high deductible to be met, or not knowing that particular surgeries and proce-dures are quite expensive. A recurrent situation in this type of dynamic often takes place in crisis scenarios — such as being transported to a hospital by ambulance that isn’t in your insurance plan’s network; you later receive a surprise medical bill even though you had no involvement in choosing an out of network hospital. 

Another example would be if you do go to a hospital that is within your insurance plan’s network (for an emergency or elective procedure), but you are treated by a physician who isn’t considered in-network by your plan. 

Hoadley clarified, “So even if you’ve done your due diligence and pick an in-network fa-cility and picked an in-network surgeon to do your procedure or an in-network obstetri-cian to deliver your baby, while you’re there, you can also be treated by an out-of-net-work anesthesiologist, or radiologist, or a cardiologist. And again, it’s not something you were told about or could control.” 

The outcome of these situations can oftentimes end with an unexpected bill showing up in the mail, informing the patient there is a balance due; this is the difference owed be-tween what the insurance company covered vs. the total amount charged for the ser-vices. According to research, approximately 20% of inpatient visits to the ER can result in a surprise medical bill, ranging anywhere from $750 all the way to $2,600 depending on what healthcare services were provided. 

How does this bill protect you? 

Patients with private insurance are protected by the No Surprises Act by not paying more than their in-network rate, even when they’re treated at out-of-network medical in-stitutions or cared for by out-of-network medical professionals, without their signed con-sent. 

As of this moment, the law does not include ambulances on the ground, however there is an advisory committee in place to formulate recommendations and help streamline the system. Their advisement covers a range of items such as full disclosure of medical service charges, to enforcement systems. 

Patients have the right to receive elective procedures by medical workers outside of their insurance plan’s network, however the No Surprises Act mandates that they have to be informed beforehand and give consent. 

What should you do if you receive a surprise medical bill? 

Ideally, after January 1, the surprise medical bills should come to a halt, but certainly the system isn’t foolproof from day one. If you still get an unexpected payment request in the mail, there are recommendations in place on how to handle it. 

Step one is to contact your health insurance company. 

Hoadley said, “When you receive your explanation of benefits, it will tell you how much you’re liable to pay and how much the policy is paying, and then you can compare that with the bill you got from the medical facility, and see whether you’re getting billed for more than you should be.” 

Next, utilize resources that are available for people who have questions about whether or not their medical bill constitutes as a surprise under this new law. The toll-free phone number to call is 1-800-985-3059, and the website is https://www.cms.gov/nosurprises. 

As always, stay tuned for the latest in healthcare news by visiting our Auxo Medical blog.