When insurance fraud was on the rise in the 1970’s, insurance companies, law enforcement and state governments got together and did things like launched joint task forces to investigate fraud and formed insurance exchanges to help manage the problem. Their first reactions were not to; in effect, legally defraud the consumer.

Fast forward to the 21^st century and the Florida legislators have approached similar fraud a different way: punish consumers. I suggest that the below conversation never took place, but you can certainly imagine it could, given informed consumers who were active in supervising the people we send to Tallahassee “on our behalf”

________________________________________

Florida Legislators: Wow, we have a really big problem with all this fraud going on in the Personal Injury Protection insurance (PIP). We need to do something.

Consumers: How do you know there is a big problem?

Florida Legislators: Extensive studies have been conducted by really, really smart people and they told us.

Consumers: Who are these people developing and providing the statistics.

Florida Legislators: The best experts in the land and we know this because they all had badges that had “insurance company paid fraud expert” on them.

Consumers: Okay, so what should we do about it? Shouldn’t we involve law enforcement?

Florida Legislators: Now, don’t you bother your little head about it, we will take care of you; don’t worry.

________________________________________

Florida Legislators to Consumers: Okay, so we have a really, really great solution to the fraud problem. Let’s see if we can explain it in terms you might understand, because it’s real complicated:

First, we pass a law that allows consumers to keep $10,000 in PIP coverage and allows insurance companies to charge for $10,000 in PIP coverage. But, we are really only going to force insurance companies to provide $2,500 in PIP coverage; unless consumers can comply with some tricky statutes and contract provisions – you know, to prove they are not committing fraud.

Consumers: Well, but, how is that fair? We pay for $10,000, but only get $2,500…

Florida Legislators: Now don’t you worry, we have you covered. If you go to an emergency room within 14 days of your accident and an emergency/trauma doctor diagnoses you with an “emergency medical condition”, you are golden! You get the full amount of coverage you paid for; but, well, you can not go to massage therapists, chiropractors, acupuncturists or maybe some other treatments.

Consumers: What about injuries that do not develop until after 14 days? Everyone has some bumps and bruises from an auto accident, but you would not go to an emergency room for that. What about a bad back injury, for example a herniated disc that does not really begin showing symptoms for a few weeks.

Florida Legislators: Never happens. All the best studies given to us clearly show that 14 days is the magic number. Any injuries you claim to have developed after 14 days are just fraud – pure and simple.

Consumers: But, if the injuries are actually proved to be real and from the accident, we get the full coverage, right?

Florida Legislators: Hmmm, probably not, because you are faking. So, you can sue the insurance company and 3 or 4 years later you may win because some “activist judge” decides he thinks you should get $10,000 in coverage simply because you paid for that amount.

Consumers: How is this law in our best interest?

Florida Legislators: Our insurance company backers, er, friends, er “expert advisors” have told us that insurance companies are going to leave Florida if we do not do something about all this fraud in PIP insurance.

Consumers: Well, rather than punish us, why doesn’t the insurance industry and law enforcement get together and fight the fraud?

Florida Legislators: But, they said they would leave and stuff; and they mentioned political contributions; and then they told us this was the way to go.

Consumers: Do you think you acted in our best interests when you cut the deal with insurance companies and passed this law?

Florida Legislators: See, we knew you would get all emotional about it. This is business and it’s in your best interests. Our friends told us so. Besides, you need to look at it in the “bigger picture”. Plus, Governor Scott signed the law, so it must be about creating jobs and lofty things like that.

Wrigley, the gum company, will stop the production of chewing gum that includes a caffeine jolt until the U.S. Food and Drug Administration (FDA) figures out to how regulate caffeine-enhanced consumer items.

The new gum was marketed as Alert Energy Caffeine Gum and it contains about 40 milligrams of caffeine, reports Reuters, about the same amount as a half cup of coffee.  Chewing the pack would be the equivalent of four cups of coffee, according to the FDA website.

The announcement from Wrigley comes less than a week after the FDA announced it would take a “fresh look” at the issue of caffeinated products, the gum just the latest in an array of products largely aimed at a young consumer.

Alert gum has a slightly bitter taste and is not marketed at children, but at adults age 25 and older. Other similar products include Stride Spark Gum with vitamins B6 and B12 and Trident Vitality Gum with ingredients such as Vitamin C, green tea and ginseng.

FDA is increasingly concerned with how to regulate the growing field of caffeinated products especially in light of the adverse events reported such as heart attacks suffered by some young users of energy drinks. In November, the agency received reports of 18 deaths and 150 injuries linked to caffeinated products.

Historically this is not entirely a new problem. In the 1950s, the FDA approved the use of caffeine in cola drinks. Since then there have been a plethora of caffeine-fuelled products. Leading the pack are energy drinks with names like Monster and Jolt.  Monster Beverage Corp skirts FDA regulations by calling its product a dietary supplement. The FDA does not regulate dietary supplements and allows the industry to self-regulate.

The central concern is the effect of too much caffeine on developing youngsters, particularly the neurologic and cardiovascular effects.   Fox News reports that major medical associations fear children may not be able to process caffeine as well as adults.

The American Academy of Pediatrics does not recommend caffeine or caffeine-containing products for children.

Make no doubt about it. Caffeine profiteers see children and adolescents as a potential market. Food manufacturers have jumped into the trend such as Arma Energy Snx which contains caffeine. Recently Jelly Belly “Extreme Sport Beans” have been launched with 50 milligrams of caffeine, according to Fox News, in every 100-calorie pack.

An FDA spokesman, Michael Taylor, noted that “some in the food industry are on a dubious and potentially dangerous path,” reports the Los Angeles Times.

The FDA is finally poised to establish some guidelines and boundaries which could include a designation as a food additive. The amount of caffeine added to consumer products could then be restricted.

They are called “legal” drugs, but for the thousands of fatalities that result from their use the comparison with illegal drugs is a distinction without a difference.

The federal Centers for Disease Control and Prevention (CDC) reports that the number of deaths attributed to prescription painkillers now exceeds those attributed to illegal street drugs such as heroin and cocaine.

PBS recently talked to the family of Oklahoma Sooners Linebacker, Austin Box, who died in 2011 from a combination of five pain medications and an anti-anxiety drug that stopped his heart at the age of 22. No one had any idea that this young man was addicted to prescription painkillers.

The CDC reports the number of deaths attributed to prescription drugs had quadrupled in the U.S rising from 4,030 fatalities in 1999 to 16,651 in 2010. OxyContin, Vicodin, Opana and methadone are believed to be responsible for about 125,000 U.S. lives over the last decade and the CDC reports that is just part of the picture.

For every fatality there are 32 emergency room visits, 10 drug treatment admissions and 130 other users who are addicted.

The CDC reports on the Top 10 things you should know about Prescription Drug Abuse:

1. More Americans are killed by drug overdoses than car crashes – about 105 deaths every day.
2. There were enough painkillers prescribed in 2010 to medicate all U.S. adults every four hours for one month.
3. Prescription drugs deaths increased four times from 1999 to 2010.
4. Non-medical use of painkillers for a “high” is sought by one in 20 Americans.
5. It is suggested you hide or lock up prescription painkillers or dispose of them properly.
6. Community and state policies are being employed to prevent painkiller drug overdoses.
7. The Patient Review and Restriction Program and Prescription Drug Monitoring Programs can coordinate care for patients.
8. State laws can address doctor shopping and pill mills.
9. Substance abuse programs can intervene and help save lives by reducing overdoses among addicts. 
10. Prescribers should turn to painkillers as a last resort, prescribe only what is necessary and monitor patients for substance abuse.

The problem isn’t just with teenagers but of adult Americans as well. The CDC estimates about 12 million adults and teens used prescription painkillers to get a “high” while emergency room visits have doubled to nearly a half million.

Even if you are not a statistic, the CDC estimates the painkiller epidemic is costing all Americans more than $72.5 billion annually in related healthcare costs.

In the United States most hospitals operate for profit so it’s a bit disturbing when a report says that complications actually work to increase the profits of a hospital. In other words, as complications increase, profits increase.

Not that anyone is intentionally increasing the complication rate, but the Boston Consulting Group reports that patients on Medicare or private insurance who experience complications after surgery may provide higher profits for that hospital.

Published in the Journal of the American Medical Association (JAMA), researchers from Harvard Medical School found when a patient experiences a blood clot, stroke, septic shock or cardiac arrest the hospital’s profit margin jumps 330 percent higher when compared to a patient with no complications.

That translates to $56,000 for a privately insured patient compared to $17,000 when the outcome is complication-free. For a Medicare patient hospitals will receive $3,600 for a patient with complications versus $1,800 for a complication-free surgery.

When a hospital has fixed costs for patients covered by Medicaid or the patient covers their own care, the hospital will make less money if it has to cover the costs of a complication.

One co-author believes the incentive process is backward.  Instead of rewarding a hospital with fewer complications, those with the most problems actually make more money on patients who have to stay in the hospital longer and receive additional care.

The Boston Consulting Group analyzed data from more than 34,000 surgeries performed at the 12-hospital system of Texas Health Resources. Among those 5.3 percent of patients or 1,820 experience some type of types of complications.

While it’s always been known there is no incentive system for quality hospitals it was never understood before just how badly things had swung in the opposite direction. An investment in reducing risk may not help underwrite hospital costs but it goes a long way in improving patient confidence and outcomes and underscores the need to focus on payment reform in conjunction with healthcare reform.

The U.S. Food and Drug Administration (FDA) has proposed tightening regulations over heart defibrillators after dozens of recalls, failures and deaths attributed to the malfunctioning medical device. There are about 2.4 million automated external defibrillators (AED) in public places in the U.S. They are found in newsrooms, airports, casinos, even churches.  Using paddles that deliver an electrical jolt to the chest, an AED can re-establish a normal heart beat during a potentially fatal cardiac arrhythmia which, according to the American Heart Association, kills about 400,000 a year.

No one knows how many patients have died due to the malfunctioning devices, but the New York Times reports in one case a nurse was trying to help a patient in cardiac arrest when the defibrillator read “memory full” and it shut down. The patient died. In another instance the software showed an “equipment disabled” message. That patient also died.

The FDA reports that there have been 45,000 failures of defibrillator hardware and software since 2005, and manufacturers have had to recall AEDs 88 times. In order to improve that dismal record, the proposed order will require manufacturers to make available designs of the AEDs. The agency would also be given tighter controls on buying defibrillator components overseas.  Dr. William Maisel with the Center for Devices and Radiological Health (CDRH) announced plants could also be inspected, although historically the FDA has not had the personnel to inspect plants overseas.
The FDA could have downgraded AEDs to a lower or moderate risk device (Class I or II), but an expert panel convened in October 2011 recommended AEDs remain Class III (highest-risk medical device) and required pre-market approval (PMA),  higher degree of scrutiny than the current notification process.

One application for PMA approval would cost about $248,000 according to Dr. Maisel, but that would cover all models of AEDs made by the company. Dr. Maisel says the safety data has already been conducted by the companies so most will not have to do any additional clinical studies.   The revamp of FDA safety oversight should be completed by 2014.

AEDs are known as “pre-amendment devices” which means that they were already in the marketplace before 1976 when the FDA began regulating medical devices.  At that time there were 170 devices called Class III that were approved through the 510(k) notification process that were never required to submit PMAs.  The FDA’s website says 19 medical devices are still waiting to be reclassified, including the high-risk metal hip joints with uncemented acetabular components as well as cemented acetabular components.

How do we know they are safe and effective?

The simple answer, which would surprise most patients and physicians, is that we do not know if the medical devices are safe and effective. A study published in the Archives of Internal Medicine in 2011 found nearly three-quarters of medical devices that caused injury or death from 2005 to 2009 had entered the market through the 510(k) process.   Any changes in the 510(k) process, however, would also need to address the false notion that the PMA process leads to safer medical devices.  That is not necessarily the case, with the Birmingham metal-on-metal hip implant marketed by Smith & Nephew being a prime example of a PMA-approved medical devices that has injured untold thousands of patients who have had to undergo revision surgeries and suffered other bone and tissue damage and disability as a result of cobalt and chromium poisoning and premature failure of the devices.

When I was a kid, I knew we were poor. What I did not know and my mother saved us from ever experiencing was being homeless. But, I have had homeless relatives and homeless friends with whom I went through with them the struggle to come out .

In Palm Beach County there are over 750 homeless families and over 1600 homeless children at any given time.

I know a guy who gives me a ration of criticism for giving money to people along the road. His response is they are all drug addicts, criminals or just plain lazy. He says the solution to homelessness is to make everyone get a job and “learn how to support themselves”.

I can tell you from experience and from learning about it that being poor or being homeless has a lot less do with laziness and a great deal more to do with a few missteps and a lot of bad luck. In our present economy, those of us in the middle class may be simply the loss of a job away from homelessness.

Have you ever begged for money? Panhandled along the busy streets? Begged for food? It is a sad and difficult skill to learn. First, you have to overcome the fear and shame you find yourself in a position of having to do it. You have to harden yourself against the people who look at you with disdain and judgment written all over their faces. You have to prepare yourself for the taunts, insults and, sometimes, the food thrown at you.

One of my bosses here at the law firm, Jack Scarola, has spent the better part of his adult life working with a worthy organization called “The Lord’s Place”. Jack is a past chairman and a regular at what The Lord’s Place calls the “Sleep Out”. If it is like nearly every year, Jack’s beautiful wife Anita will be with him as will many of his friends and family. They will all gather at the Meyer Amphitheater at 6:00 PM and sleep outside all night long.

The Lord’s Place is not a place for a hand out as much as a leg up. It is an organization that will help individuals and families find a place to sleep, a place to eat and will help them get back into the job market. My wife is a principal and many of her students would not have been at school today but for The Lord’s Place helping their family. Sadly, I know about families right now living in their cars, but still trying to get their kids to school and themselves to a job.

Jack Scarola and all the volunteers will not just be sleeping out under the stars in the torrential downpour or through the onslaught of mosquitoes; they are also raising funds to help the Lord’s Place help the homeless by giving them just a little leg up.

So, if you believe as I do; that in a country like America no one and certainly no children should have to be homeless or hungry reach into your pocket and support this worthy organization. It is only a click away right here!

For a diabetic, accurately monitoring his blood sugar level can mean a matter of life or a diabetic coma.

So this latest warning from healthcare giant Johnson & Johnson is especially troublesome.

Its popular OneTouch Verio IQ blood glucose meters have been found to be faulty when the blood sugar is especially high. Instead of providing a warning, they turn off.

J&J is recalling almost 1.9 million units following the death of a patient in Europe.

About 900,000 units were sold to U.S. consumers. The problem was detected when a high blood sugar of 1,024 milligrams per deciliter caused the device to trip off.

The company says the likelihood of reaching that level of blood glucose is remote but the failure to deliver an accurate reading could delay treatment that can result in serious complications including death or a diabetic coma.

Just for comparison, a diabetic wants to keep his blood sugars in the range of 160 milligrams per deciliter or below. Any higher and the sugar travelling through the body can damage the heart, eyes, blood vessels and other organs. Amputations, blindness, kidney failure and heart attack can result when blood sugar goes unchecked.

These meters were sold in the U.S. and in other countries. J&J’s LifeScan unit says it will replace them for free. Those recalled include the OneTouch VerioIQ, OneTouch VerioPro, and the OneTouch VerioPro+.

The VerioIQ meter can be used until replacement meters come in.

The problem was detected by internal company testing soon after the patient died following an inaccurate reading which may or may not have been linked to the medical device.

Over the last couple of years, J&J has issued about a dozen recalls for faulty medications, contact lenses and hip implants. You’ll recall the children’s Tylenol and Motrin recalls, the DePuy ASR metal-on-metal hip recall, a bone putty to stop bleeding and the complete overhaul of a nonprescription medicine factory that was taken over by the FDA after an inspection found contaminated products and dirty conditions.

Bloomberg reports 2012 sales of LifeScan diabetes care products at $2.6 billion.

Visit the company’s website www.onetouch.com or contact customer service at (800) 717-0276 to return the meter.

If you are over the age of 65 a dangerous fall could be in your future according to federal health regulators.

None of us likes to think we’re getting older but the Centers for Disease Control and Prevention (CDC)  finds that among Americans age 65 and older, one in three will experience a fall every year with results than can range from minor to fatal. Even a minor fall can lead to head trauma that is not initially recognized.

According to the CDC there were 2.3 million Americans who experienced falls in 2010 and were treated in emergency rooms. Among those more than 662,000 were hospitalized with injuries that included hip fractures, lacerations and head trauma.  Hitting your head can easily cause anything from traumatic brain injury (TBI) to a concussion and can be experienced by people of all ages, but falls are the most common cause according to the CDC.

Falls are the cause of hip fractures about 95% of the time says the federal agency.

Falls are preventable if some precautions are taken.

• Americans of all ages commonly trip from pets, loose rugs or objects on the floors or furniture that is in the way. The CDC recommends your walking space be adequate and the floors have a lot of traction.
• A grip bar in the bathroom is recommended especially around the tub, shower and next to the toilet.
• Keep areas well lit.
• Have eyes examined and update glasses prescriptions as needed.
• The CDC suggests regular exercise will increase leg strength making a fall less likely and recovery easier.
• Any dizzy spells should be taken seriously. A consult with a physician can help determine if a medical condition is causing dizziness or a medication may be the cause.

The CDC campaign called, “Heads Up to Brain Injury” was created to recognize March as Brain Injury Awareness Month.

TBI causes at least 1.7 million injuries every year and can be described as a head injury that alters the normal functioning of the brain. Even a mild bump can cause TBI. The majority of TBI are concussions.

The CDC reports there are about 3.5 million Americans with TBI which has proven fatal to 53,000.

Wearing a seat belt, avoiding drunk and distracted driving and wearing a helmet are some suggested ways to protect your head from blows.

The Food and Drug Administration (FDA) is cracking down on compounding pharmacies after a nationwide fatal outbreak of fungal meningitis was found in contaminated steroid injections made at the New England Compounding Center (NECC).

Now a Georgia compounding pharmacy, Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, has voluntarily recalled all lots of sterile syringes loaded with the cancer drug Avastin. The recall was undertaken after an FDA inspection revealed sterility concerns.

At least five people have serious eye infections associated with the Avastin drug that was repackaged from vials into syringes by CSCP. The condition is called endophthalmitis, which the FDA reports occurs inside the eyeball and can lead to permanent blindness. The link to the syringes was brought to the federal agency’s attention by the Centers for Disease Control and Prevention (CDC).

The FDA is playing catch-up after 48 people died from a contaminated epidural steroid injection. Over 700 patients continue to be treated for fungal infections and hundreds of lawsuits have been filed against NECC, which has filed for bankruptcy.

Historically, compounding pharmacy regulation has fallen outside of FDA radar and states have not been picking up the slack. There is a move to increase the FDA’s authority over compounders and the surprise plant visits are part of the plan.

Meanwhile the voluntary recalls continue with three announced during one week in March.

Med Prep Consulting of Tinton Falls, New Jersey voluntarily recalled 83 types of antibiotics and drugs used during surgery because of a possible mold contamination, which was visible to the eye. Regional hospitals in New Jersey, Connecticut, Delaware and Pennsylvania received the infusion bags, glass vials and plastic syringes linked to the mold.

An inspection at Pallimed Compounding Pharmacy of Massachusetts led to the recall of all sterile products made at the plant in an “abundance of caution” even though there had been no injuries reported. The FDA inspectors indicated there were “deficiencies” but the recall does not include the facility’s non-sterile products.

The state took the next step and issued a “limited Cease and Desist Order” to prevent the sale of 16 sterile compounded products. Last December, the Boston Globe reports the company had been ordered to stop compounding Viagra because of “improper components.”

Originally, compounding pharmacies were developed to mix small batches of custom ordered drugs. Depending on the individual state’s regulations, they were not intended to become full-blown mini-pharmaceutical manufacturing facilities, but that is the role many have undertaken.

State laws vary and the FDA is seeking additional authority over the growing industry, however, as we’ve seen so many times, the agency does not have enough funding to oversee about one-quarter of the consumer products used by Americans.

One proposal has the compounding companies pay a user fee to cover the cost of FDA inspections.

Bottom line – inspect the products coming from a compounding facility. In the case of the mold, a nurse, not FDA regulators, noticed the contamination problem which led to the recall.

They have barely found themselves back on land and a number of lawsuits have already been filed against Carnival Cruise Lines over the disastrous ship Triumph’s trip from hell.  An engine room fire on February 10 left the 3,000 passengers with no toilets or air conditioning, little food and fresh water for five days until they were towed back to the Port of Mobile, Alabama.

The passengers remained helpless at sea about 150 miles off the coast of Mexico for five days. It’s still uncertain why the ship remained disabled for so long.

CNN reports a class action lawsuit has already been filed by passengers who say that Carnival knew or should have known “that the vessel Triumph was likely to experience mechanical and/or engine issues because of prior similar issues.”

The ship’s condition presented a risk of injury, illness and disease, but reportedly there was only one man taken off the ship who had to be treated for dehydration at a Houston hospital. Considering the fact that feces overflowed from toilets onto the ship, there was little or spoiled food to eat and with no air conditioning, passengers had to sleep in public areas, it’s amazing more people were not sickened.

Even though others are likely to join this class action you should know it is very difficult to sue any cruise line. That’s because the small print on the back of your ticket contains your legal obligations and rights with the corporation and Carnival has covered itself for any eventuality including bad weather or mechanical problems.

The mechanical condition of the Triumph before it launched from Galveston, Texas for the four-day cruise to Mexico will be explored. A fire reportedly broke out damaging the propulsion system and generators and knocking out power. The fire started from a leak ignited from a fuel-oil line from one engine.

One of the lawsuits filed in Miami claims the Triumph had mechanical troubles recently so it will be important to determine whether Carnival was negligent in allowing the ship to return to sea so quickly.

Passengers are generally restricted to filing in the Miami jurisdiction under the rules as set out on the back of the ticket. Consumers are reminded to read the fine print which is essentially an iron-clad contract between you and the cruise line.

Usually a judge must decide whether the contract can be waived and a class action can be filed. Otherwise you might have to depend on the cruise line and its willingness to win some public relations good will.