MCN | Medical Consultants Network

The Power of a Second Look

Home / MCNTalk / Tag: Legal Issues

Viewing items tagged:

Legal Issues

Who Is Paying the Price for Drug Coupons?

by Angela Sams

Many of us have probably at some time or another been faced with an expensive prescription that we wish we didn’t have to pay for, instead wishing for some kind of coupon or discount to help foot the bill. According to a recent article in Bloomberg Business, some pharmaceutical companies are providing just that, spending approximately $7 billion to generate discounts and coupons for patients’ drug co-payments.

Why are some prescriptions so wildly expensive? The short answer is that insurance companies want the drugs to be so unaffordable that patients won’t use them. Much to the chagrin of insurers, pharmaceutical companies have responded by paying for patients’ prescription co-pays, handing the rest of the balance right back to insurers. This is not allowed everywhere, however. Because the cost of a patient’s co-pay directly influences whether or not they will pay for their prescription, co-pay coupons are banned in the Medicare program, cited as an illegal inducement.

Drug companies see the coupons—distributed online, in magazines, and in doctor’s offices—as helpful to consumers. Holly Campbell of the trade group Pharmaceutical Research and Manufacturers of America states that “co-pay offset programs can play an important role in maintaining access to needed medicines, especially for patients taking specialty medicines or with chronic conditions.” But providing these coupons helps the drug companies as well. Indeed, they “can earn a 4-to-1 to 6-to-1 return on investment on co-pay coupon programs.”

Insurance companies are resisting the coupons by nixing drugs from their plans, and creating a rewards program that would give cash to patients who don’t use the coupons. United Healthcare has been leading the way in the fight against the co-pay coupons, in part due to the fact that the discounts can keep patients from seeking drug alternatives that are equivalent to the more expensive option. A spokeswoman for United argues that when consumers choose a pricier drug because they have a coupon, this can have a huge impact on healthcare costs overall. The battle between insurers and drug-makers leaves consumers caught somewhere in the middle. And it leaves one to wonder, could the problem potentially be solved if drug prices were simply lowered?

Dangerous Risks of Using Opioids to Treat Pain

by Angela Sams

Have you ever been prescribed a painkiller to help with surgery recovery or maybe for back pain that just won’t go away? Even if not, it is likely that you know someone who has been on a painkiller medication at some time or another. That likelihood rose steadily between 1999 and 2010, as doctors began turning to a “quick fix” that will treat their patients in an aggressive manner. But, as patients cooperatively swallow their prescribed pills, it is important to consider the downsides of opioids on an individual and societal level.

A recent opinion article in the New York Times indicates that while there has been a “steady increase in the mortality rate of middle-aged white Americans since 1999,” this is not the case in other age and ethnic groups, or even with people in the same age group who live in other countries. Consider this disturbing statistic: “In 2013 alone, opioids were involved in 37 percent of all fatal drug overdoses.” It is clear that opioid overdose is quickly becoming an epidemic, and a major shift in attitude is a key to the problem.

At one time, opioids were used mainly for pain caused by terminal illnesses or as a short-term fix for pain after surgery. However, during the 1990s, drug companies began marketing to doctors, encouraging them to “be proactive with pain and treat it aggressively.” Afraid of being seen as uncaring or reprimanded for not treating a patient’s pain to the best of their abilities, doctors fell for the marketing scheme and began prescribing powerful opioids such as OxyContin.

Though opioids may relieve pain and help a patient recover more comfortably, evidence suggests that they should only be used for short-term treatment, not long-term treatment of nonmalignant pain.  There are also many downsides to taking such a medication. This type of painkiller is extremely addictive, may affect mental health, lead to unemployment, and cause poor health in general, to name a few risks. Ironically, using these drugs can also make a patient more sensitive to pain.

So what is the solution to this problem? Should people suffer in pain, rather than take the risks associated with opioid drugs? Actually, the answer may be as simple as taking an over-the-counter medication. In one study, researchers found that when Motrin and Tylenol were combined, they were actually more effective than opioids, not to mention safer. While opioids are still very readily available to patients who are in pain, small steps towards a solution have been taken. For example, the Food and Drug Administration issued a Risk Evaluation and Mitigation Strategy, ensuring that opioids now contain warning labels. The makers of these drugs must also give training and education that will help doctors prescribe them safely. Certainly, patient awareness is helpful, but only time will tell if physicians can turn this shift in attitude back around, and work towards other, safer solutions for pain management.

The Price is Right? Wrong!

by Jen Jenkins, Market Analyst

The most recent case of a pharmaceutical company exorbitantly raising the price of an otherwise inexpensive drug has brought certain “Big Pharma” issues careening back into the spotlight. Turing Pharmaceuticals acquired a 62-year-old drug called Daraprim back in August. This drug, used mainly to treat a rare parasitic infection in patients with compromised immune systems such as babies, or adults with AIDS/HIV and cancer, originally rang in at $13.50 a tablet; that is until Turing acquired it and the price per tablet soared to $750. More attention is typically bestowed upon the high prices of new drugs, but this particular situation brings to light an evolving issue of mind-boggling price increases in drugs that have been around a long time and are mainstays in certain types of care.

A huge concern with these increases is that hospitals are more likely to turn to alternatives that may not prove as effective. Although high prices are known to happen within the industry due to shortages, the cases described here are happening merely due to business strategy. Other examples, just to name a few, include a drug called Cycloserine, which increased from $500 for 30 pills to $10,800; also, just last month two members of Congress investigated another incident where two separate heart drugs, Isuprel and Nitropress, were acquired by Valeant Pharmaceuticals and subsequently raised in price by 525% and 212% respectively.

The 32-year-old founder and chief executive of Turing explained the recent price hike away by saying it is now more in line with other drugs that treat rare diseases and that most patients use the drug for far less than a year anyway. The sad truth of it all is that the CEO’s unapologetic response to the backlash of the situation is far from unusual, as is the fact that his drug company is only one of many that has and will continue to unconscionably inflate prices.

Read about this  in further detail in these New York Times and Washington Post articles.

The Physician Who Saved Countless Babies from Birth Defects

Dr. Frances Oldham Kelsey, who died last week at the age of 101, became a 20th-century North American heroine for her role in the thalidomide case, celebrated not only for her vigilance, which spared the United States  from widespread birth deformities, but also for giving rise to modern laws regulating pharmaceuticals.

In 1960, Kelsey was hired by the FDA in Washington, D.C. At that time, she was one of only seven full-time and four young part-time physicians reviewing drugs for the FDA. One of her first assignments there was to review an application for the drug thalidomide as a tranquilizer and painkiller for pregnant women for morning sickness. Even though it had already been approved in Canada and more than 20 European and African countries, she withheld approval for the drug and requested further studies. Despite pressure from thalidomide’s manufacturer, Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.

After  the story received press coverage in July 1962, there was a substantial public outcry. The Kefauver Harris Amendment was passed unanimously by Congress in October 1962 to strengthen drug regulation. Companies were required to demonstrate the efficacy of new drugs, report adverse reactions to the FDA, and request consent from patients participating in clinical studies. Read more about Dr. Kelsey…

DNA Dilemmas

by Jen Jenkins, Market Analyst, MCN

DNA, or deoxyribonucleic acid, contains the genetic blueprint that distinguishes each and every human being. Since its advent in 1985, and with a 99% accuracy rate, DNA testing has emerged as the most reliable physical evidence available, particularly at crime scenes. The TV show CSI popularized the science behind forensic testing but over the years it has also become widely accessible for many other purposes. Disturbingly, as the tests have become more accurate and less expensive, we are also seeing evidence of discrimination that has arisen due to having this type of information so readily available.

Laws have indeed come about to specifically protect people from discrimination due to genetic testing. The most newsworthy example of this was seven years ago when Congress prohibited employers and insurers from discriminating against people with genes that showed an increased risk for developing diseases that may be costly to treat. A more recent article in The New York Times, “‘Devious Defecator’ Case Tests Genetics Law,” is an interesting, albeit bizarre, example of the serious issues and concerns surrounding this topic. Two men accused of defecating publicly outside a warehouse where they worked were subjected to a DNA test in order to compare their DNA with that of the feces. Both men, fearing the possibility of losing their jobs, agreed to the testing and were subsequently cleared. Following the debacle the men sued the company on the grounds that the genetics law in place made it illegal for the employer to have requested or required genetic information under any circumstances.

“Anyone in the future thinking about using a genetic test in ways that can embarrass or harm an individual will have to confront the fact that it violates federal law,” stated a Georgetown University law professor regarding the case. Nevertheless, although the United States justice system has many existing laws when it comes to awarding damages for other types of discrimination, there are no laws or guidelines in place specifying how judges may award justly for discrimination due to genetic testing misconduct.

Making (Common) Sense out of HIPAA

by Brian L. Grant MD

That HIPAA is misunderstood is an understatement. As this article in The New York Times describes, HIPAA is used as an excuse for absurd interpretations and ultimately a denial of rights to communicate by non-covered entities, a refusal to receive information from family members, churches who erroneously believe they can no longer share the fact that a congregant may be ailing, and other forms of nonsense.

If I had a quarter for every person who made declarative but incorrect statements about HIPAA, it would buy a lot of coffee, and some pastries to boot!

The goal of HIPAA is to maintain the privacy of medical information. But many questions remain. For example, why is unencrypted email apparently unacceptable but a fax is OK, though many senders or recipients of faxes send the faxed documents as Internet attachments? Is an email less secure than the US mail, which could result in a piece of paper lying on a desk in plain sight of the wrong people? I imagine that if the NSA or North Korea has an interest in the files of a medical practice, they may view them with minor effort. But does encrypting email actually solve a problem of files being compromised? The reality is that unencrypted email use is not prohibited. What is prohibited is accessing and reading such information by an individual or more who are not authorized. That raises the theoretical concern that people with time on their hands at Yahoo or Google are opening and viewing emails containing PHI (protected health information).

Protecting medical privacy is important and HIPAA is well-intended and to the degree it compels the profession to establish guidelines, training and evaluating of who and how one shares medical information, it is a good thing. But we have a ways to go to achieve clarity, reduce barriers to good care, and maintain compassion along with common sense.

A Changing Landscape: America’s Opiate Epidemic

by Jen Jenkins, MCN Market Analyst

Many Americans have developed an expectation for something that on the surface appears harmless but in reality has proven rather dangerous: the quick fix. This expectation falls into a variety of categories but the dangers here tend to lurk around seemingly magical solutions that directly involve our health.

During the 1990’s there was a surge in pain medication being prescribed freely as an easy fix for chronic pain sufferers over the use of other types of rehabilitation. Prescribers were outspoken about their belief that these drugs were not addicting when used in these scenarios and pain medication was not only being freely prescribed but done so in enormous excess. Between 1999 and 2010 the US saw sales quadruple for opioids such as Percocet, Vicodin and OxyContin. These names probably sound familiar as they have readily become household names, yet we are only more recently being warned about the dangers of using these drugs.

On the other hand, heroin is widely known to be illegal and highly addictive. Fatal heroin overdoses in this country have almost tripled in the past three years, claiming the lives of more than 8,250 people per year. As horrifying as that is, it may not be all that surprising since the dangers of heroin are so well known.  In a shocking comparison, around double that number of people are dying every year from prescription opioid painkillers, which are molecularly similar to heroin. If that statistic is news to anyone it’s probably because overdoses due to prescription medications are far less scrutinized and rarely publicized. The victims of these overdoses are overwhelmingly white, financially well-off, and young; a very different demographic from what we have come to know in relation to other types of drug abuse.

This article in The New York Times provides a snapshot of the new heroin landscape and why it is more dangerous than ever before. Use of this addictive drug had been on decline since the 1980’s but was revitalized thanks to prescription opioid addicts who are more readily turning to heroin as a less expensive and more accessible alternative for a similar high. The article goes on to look at how this change of demographic has also brought about a new kind drug dealer, in particular highlighting the business practices of the group of traffickers dubbed “The Xalisco Boys.”

Although low-profile and anti-violent, The Xalisco Boys are drug dealers to fear because they are going after their customers instead of the old standby of waiting for customers to come to them. They also rely on marketing instead of perpetuating street crime and have devised a system resembling pizza delivery for selling heroin across the United States. Interestingly, they even keep business hours between 7am and 7pm to instill a “safe” sort of atmosphere along with reliable delivery and balloons of heroin that have been properly dosed out by weight and potency. Free samples given out at methadone clinics, discount pricing, and free hits delivered to customers showing signs of quitting are cited all examples of their entrepreneurial take on drug sales.

So what do we do in this ever-changing landscape?  Do we look for resolution on the street or in our clinics and hospitals? Especially now that “street crime is no longer the clearest barometer of our drug problem; corpses are.”

Dr. Oz to Respond to Criticism

Dr. Mehmet Oz will question the credibility of critics who sought to have him removed from his position at Columbia in a segment on his show on Thursday, a spokesman for the show said.

Why is this important, and why does MCNTalk care? Dr. Oz has noted on his Facebook page, “I bring the public information that will help them on their path to be their best selves. We provide multiple points of view, including mine which is offered without conflict of interest. That doesn’t sit well with certain agendas which distort the facts.”

But in the multi-billion dollar world of celebrity and supplement endorsement, is there such a thing as “without conflict of interest?” And, as we noted in 2013, “In medicine there is a continuum between hard science, that which can be objectively observed and tested, so-called ‘art,’ and unsubstantiated beliefs masquerading as science.”

There is certainly no harm in being a good person and given the nature of many illnesses, conveying warmth while the body heals itself may be more than enough. But promoting amulets, strange foods, and other hocus pocus presented by charlatans does a disservice to society. Oz appears to personally promote unproven products and their promoters in his show – conveying an irresponsible and unearned aura of legitimacy. It appears he has embraced celebrity at the expense of credibility and his millions of fans are none the wiser.

New Measles Case Reported in Oklahoma

According to the Centers for Disease Control and Prevention, measles was effectively wiped out in the U.S. in 2000. From the CDC website: “The United States was able to eliminate measles because it has a highly effective measles vaccine, a strong vaccination program that achieves high vaccine coverage in children, and a strong public health system for detecting and responding to measles cases and outbreaks.”

According to the Centers for Disease Control and Prevention, measles was effectively wiped out in the U.S. in 2000. From the CDC website: “The United States was able to eliminate measles because it has a highly effective measles vaccine, a strong vaccination program that achieves high vaccine coverage in children, and a strong public health system for detecting and responding to measles cases and outbreaks.”Yet in 2014 there were 644 cases in the United States, and thus far in 2015 there have been 178 reported cases. 74% of these were related to a much publicized outbreak linked to Disneyland. Today a new case was reported in Oklahoma, which had experienced no reports of measles in 18 years.

Worldwide measles is a serious problem, infecting 20 million people each year and claiming 146,000 lives. According to the CDC, 1 in 4 people in the United States who get measles will be hospitalized; 1 or 2 out of 1,000 will die. The 2015 outbreaks are attributed in large part to parents not having their children immunized. Dr. Gil Chavez, deputy director of California’s Center for Infectious Diseases, noted at a news conference in January during the Disneyland-related outbreak that the park would be “perfectly safe” if you’ve been immunized.

MCNTalk has frequently blogged on the anti-vaccine movement. It’s been specifically noted by multiple international public health experts that the original 1998 study involving eight children which erroneously tied autism to the measles-mumps-rubella vaccine was just that, erroneous. 

And yet parents continue to forego getting their children vaccinated. With a highly contagious disease such as measles there are consequences for opting against vaccinations. People who are unvaccinated for any reason, including those who refuse vaccination, risk not just their own infection, but spreading the disease to others, including those who cannot get vaccinated because they are too young or have certain health conditions.

Sadly, just last month Susan Mendez, education director for immunization services with the Oklahoma State Department of Health, said it could just be a matter of time before measles entered Oklahoma.“It just takes one person traveling into Oklahoma…If you’re not vaccinated, you are taking a risk.”

 

The Top 8 Jobs with the Highest Injury Rates

­

Four of the top eight are medical workers: orderlies, nursing assistants, personal care aids, and registered nurses.

According to the Bureau of Labor Statistics, more than 35,000 nursing employees are injured each year severely enough that they miss work.

Some hospitals have report that they have reduced lifting injuries among nursing staff by up to 80 percent — using an approach often called “safe patient handling.” They use special machinery to lift patients, similar to motorized hoists that factory workers use to move heavy parts. The hospitals also conduct intensive training among the staff.

Yet the majority of the nation’s hospitals have not taken similar action. The injuries are often so severe that they’re career-ending, a problem compounded by the fact that many of those injured are relatively young. To help address the problem, on Jan. 1, 2012, the Hospital Patient and Health Care Worker Injury Protection Act went into effect in California. This NPR article follows several injured medical workers and their stories.