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Government Policy

Size Matters

By Brian Grant MD

Actions that infringe on individual freedoms should be done cautiously and after careful consideration. Most laws and regulations infringe. Kids are forced to go to school, drivers are forced to obey speed limits, and we are not allowed to assault others. In the realm of health, we regulate drugs, force the use of seat-belts, regulate alcohol and tobacco and so on.

The New York Times article “In Fight Against Obesity, Drink Sizes Matter,” makes a compelling case for regulating the sale and sizes of sugared drinks. If we don’t, we may one day be seen in the same light as we now view the era of unregulated tobacco, unfortunate and overdue for change. The article describes the relative ineffectiveness of warnings and education on the dangers of tobacco, with ultimate behavioral change flowing from regulation, taxation, and bans.

But history has clearly shown that teaching people what is good for them is not enough. It must be accompanied by restrictions that curb unhealthy habits and environmental changes that foster healthier ones.

Cigarette smoking is a classic example. Myriad well-publicized reports documenting its hazards — even warnings on cigarette packs — did relatively little to get people to quit smoking and keep others from taking it up. It was not until smoking was banned in workplaces, restaurants, public buildings and transportation that smokers became social pariahs and millions gave it up.

Given the striking evidence that the current U.S. levels of consumption of sugary drinks is seriously contributing to type 2 diabetes and obesity, and the availability of benign options including water and artificially sweetened drinks, it would seem apparent that regulation and limits on these drinks is inevitable and appropriate.
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This Company & Family Failed the New York Times Test

By Brian L. Grant MD

The recent fungal meningitis outbreak traced to a Massachusetts-based compound pharmacy is tragic for the many current and potential victims. And it was entirely preventable based upon the reports of major manufacturing breaches.

The New York Times article, “Spotlight Put on Founders of Drug Firm in Outbreak,” illustrates how a company and their family failed the New York Times test.

Years ago I learned the concept of the “New York Times Test”. This imaginary test refers to the importance in business and life of upholding standards of behavior and avoiding adverse actions that might cause one to end up on the cover of that venerable journal.

In other words, when considering an action or omission, one might ask themselves how they would feel if the action or outcome of one’s decision were to land on the cover of the Times. Would one be proud, or running for cover under a cloud of shame and perhaps liability.

This outbreak appears from public accounts to be a failure of leadership by the owners of the company, and a culture internally where good men and women were either unaware of the breach, or if aware (which I suspect must have been the case for at least some), chose to do nothing.

Errors of this magnitude appear systemic and not accidental. And in drug manufacturing and other mission critical endeavors where lives are at stake when there are errors, the results may not be recoverable. One can’t help but wonder what logic permitted these errors and omissions to be practiced.

More facts will undoubtedly develop with future investigations and litigation. And more than one business school lesson will flow from these events.

In the past we at MCN have confronted value breaches in our own industry. These include inconceivably brief exams and routine unnecessary ordering of imaging and other actions that may be expedient and profitable but uncalled for.These and similar acts dishonor the integrity of medicine and the patients who are compelled to attend such examinations.

To our dismay, such behaviors continue in certain settings, lowering the bar of quality and integrity for those involved, and provide cover for those who wish to criticize our industry as a whole.

We at MCN have pledged to not knowingly engage in such actions, call them out when we see them, and walk away from opportunities to follow along. We think it is long overdue for those in health services to remember and hew to their honorable medical roots. A decent living will follow.

It is much easier to act in a way where their integrity is not sacrificed. While short-term profits may take a hit by saying no to short-cuts and actions that don’t reflect the highest values, living and acting based upon such values drives long-term profits, satisfied clients, employees, and shareholders.

Behaving ethically should not be extraordinary or heroic. It should be expected and normal.

CVS to Pay $5 Million for False Drug Pricing Allegations

In one of the first False Claims Act settlements involving Medicare’s Prescription Drug Program, a subsidiary of CVS Caremark Corp., RXAmerica, agreed to pay $5.25 million to settle claims of false prescription drug pricing, according to the Washington Post.

The settlement will resolve two separate lawsuits from 2008-2009 against CVS in Woonsocket, Rhode Island. Federal investigators said RXAmerica had given false data regarding their prices of prescription drugs.

The issue arose when RXAmerica advertised false pricing on Plan Finder, a website where senior citizens can estimate their prescription drug expenses. However, the actual prices offered by the company were significantly higher than indicated on the website.

“Those navigating our Medicare system deserve accurate information so they can make informed choices and obtain the benefits to which they are entitled,” said Loretta Lynch, U.S. Attorney for the Eastern District of New York. Read More…

Similar to the settlement against CVS  earlier this year, this agreement is part of the government’s initiative to combat health care fraud.

 

 

Follow up: Scott’s Story and the Election

By Vanessa Radatus

After last week’s article, “A Possibly Fatal Mistake,” by Nicholas Kristof, a number of responses prompted further discussion on the issue of health reform and our upcoming election.

In a follow-up column, “Scott’s Story and the Election,” Kristof provides two counter arguments acknowledging those who do not agree that it is the government’s (or their) responsibility to take care of the millions who are unable to do so themselves.

His first argument reflects the basic idea that we must accept that imperfection as not only our present reality, but our human destiny. That is why our government has created safety nets in our laws and institutions to prevent and mitigate human error. Kristof states:

“First, a civilized society compensates for the human propensity to screw up. That’s why we have single-payer firefighters and police officers. That’s why we require seat belts. When someone who has been speeding gets in a car accident, the 911 operator doesn’t sneer: “You were irresponsible, so figure out your own way to the hospital” — and hang up.

To err is human, but so is to forgive. Living in a community means being interconnected in myriad ways — including by empathy. To feel undiminished by the deaths of those around us isn’t heroic Ayn Rand individualism. It’s sociopathic. Compassion isn’t a sign of weakness, but of civilization.”

Kritsof’s point should not be neglected. Does not every American citizen feel that our government is somewhat responsible for keeping our nation’s people safe? Why then, do we have government-created agencies like the FDA, the FDIC, and Social Security?

Because we as a nation have learned from our past and humans make mistakes. And if we have these institutions to act as safety nets for our food, medicine, and money, shouldn’t there be something to act as a guard rail to protect our nation’s health?
Kristof’s second argument is that if you don’t believe in universal healthcare because you don’t want to pay for the mistakes of the uninsured, you are already paying for them, only, at a higher rate.

“My second argument is that if you object to Obamacare because you don’t want to pay Scott’s medical bills, you’re a sucker. You’re already paying those bills. Because Scott wasn’t insured and didn’t get basic preventive care, he accumulated $550,000 in bills at Seattle’s Swedish Medical Center, which treated him as a charity case. We’re all paying for that.” Read More…

So as our last presidential debate airs tonight, watch it. Become an informed voter. Try not to be persuaded by a candidates looks or demeanor but rather by his ideologies and how he will try to make our country better for everyone, rich or poor, old and young.

If you would like to learn more or follow Nicholas Kristof, visit him at his blog, On the Ground, or join him on  Facebook and Google+, watch YouTube videos and follow him on Twitter.

Drug Distributors Pressured to Reduce Narcotic Painkiller Shipments

Over the past few months, the DEA has tried a variety of different tactics to battle our painkiller epidemic.

From arresting hundreds of doctors, cracking down on pill mills, and investigating pharmacies, it’s most recent attempt has large drug distributors rattled.

The New York Times reports that after honing in on Florida and Ohio, the DEA is now putting pressure on other pharmaceutical distributors nationwide.

Earlier this year, the agency charged drug distributor Cardinal Health for violating it license to sell controlled drugs. Since then, Cardinal no longer does business with a dozen pharmacies in Arizona, California, Nevada, and Oklahoma and the number is growing.

The article notes that the pressure has pushed distributors to create a nationwide shipment reduction to pharmacies and doctors who order a high volume of narcotic pain killers.

“We had a strong anti-diversion system in place, but no system is perfect,” Cardinal Chairman and Chief Executive told the Times.

Since then, they have strengthened their criteria and  have also  created a committee that evaluates pharmacies that order large amounts of narcotic drugs.

Another major distributor, AmerisourceBergen, recently disclosed that it also faces a federal criminal inquiry into its oversight of painkiller sales.

The DEA’s crackdown on pharmacies and big distributors like Cardinal and AmericsourceBergen have shown that the agency is taking a much more aggressive approach to ending our nations painkiller issue.

However, doctors and pharmacies are critical of the way distributors have abruptly cut them off from their supply. One California pharmacist argued that his pharmacy specializes in pain patients which would explain his high volume orders.

“The drug distribution system is a sprawling one that involves about 800 companies, which range in size from a few giants like Cardinal to hundreds of small firms. For wholesalers, the markup on medications can be small, sometimes a few pennies a pill. But with billions of pills sold annually, the profits can be big. Narcotic painkillers are now the most widely prescribed drugs in the United States, with sales last year of $8.5 billion.”

There is also added incentive to sell Oxycontin and other narcotic painkiller because of their addictive properties and because street value on the black market is as much as $80 per 80-milligram dose.

However, while the DEA is implementing new tactics against distributors for failing to notify the agency of a “suspicious order” from a pharmacy or other customer, it does not share those reports with officials in the state where the pharmacy is based.

After the New York Times had asked for the agency to disclose the number of such reports it received annually, they declined saying, the agency considered such statistics “law enforcement sensitive” information.

In response, the Times has filed a Freedom of Information Act request seeking that data. Read More…

 

Rational Care Includes Economic Analysis of Value

By Brian L. Grant MD

The New York Times article “In Cancer Care, Cost Matters,” is written by oncologists who are attempting to engage in rational discourse about the cost-benefit of chemotherapy drugs. They note:

“Physician guideline-setting organizations likewise focus on whether or not a treatment is effective, and rarely factor in cost in their determinations. Ignoring the cost of care, though, is no longer tenable. Soaring spending has presented the medical community with a new obligation. When choosing treatments for a patient, we have to consider the financial strains they may cause alongside the benefits they might deliver.”

In the case of Medicare beneficiaries, they do share in the cost of medications, but generally insured individuals are frightfully blind to the cost of their care. Thus it falls upon payers and physicians to make rational decisions on behalf of patients, and the cost should be part of the equation. The cost may be relative to doing nothing, or as stated in this article, to an alternative treatment.

To suggest that price should not be part of the decision process in health care is naïve. A life is priceless, but the cost of maintaining life in a world of finite resources must include a realistic assessment of the impact of the intervention and the price associated with it. To do otherwise diverts these resources from other uses, that might include more impactful treatments for individuals and society.

And if and when companies devising such treatments understand that standards and judgment are being imposed, they may modify and adjust the costs of their products to gain more acceptance and access to the market. Read More…

 

Health Reform: A Matter of Life and Death

Access to insurance is a matter of life and death for some.

In this poignant New York Times column, “A Possibly Fatal Mistake,” Nicolas Kristof tells the sad story of his childhood and college friend, Scott Androes, who made a bad choice and may pay with his life.

That choice was not purchasing health insurance when he was marginally employed and realistically able to do so. For Scott, like many Americans, the thought of buying an individual policy in a high risk market seemed too expensive and unnecessary.

But after months of warning signs and a trip to the emergency room later, Scott realized how costly taking that risk would be. This year, he was diagnosed with metastatic prostate cancer and a treatment plan that is upwards of $550,000. It would appear that his days are numbered.

In his piece, Kristof compassionately writes about the bigger picture of this issue and how health care reform and politics play a major role in individual stories like his friends. He characterizes one presidential candidate’s philosophy, opposed to most of the health care reform proposals, as seeing this outcome:

“…as I understand it, is that this is a tragic but necessary byproduct of requiring Americans to take personal responsibility for their lives. They need to understand that mistakes have consequences. That’s why, he the candidate, would repeal Obamacare and leave people like Scott to pay the price for their irresponsibility.”

Kristof goes on to say:

“To me, that seems ineffably harsh. We all make mistakes, and a humane government tries to compensate for our misjudgments. That’s why highways have guard rails, why drivers must wear seat belts, why police officers pull over speeders, why we have fire codes. In other modern countries, Scott would have been insured, and his cancer would have been much more likely to be detected in time for effective treatment. Is that a nanny state? No, it’s a civilized one.”

The key point that Kristof makes is how crucial it is to put our partisan bias aside and consider the millions of U.S. citizens who are currently affected by our broken health care system. Which presidential candidate will actually work to fix and prevent stories like this after the election?

“So as you watch the presidential debates, as you listen to those campaign ads, remember that what is at stake is not so much the success of one politician or another. The real impact of the election will be felt in the lives of men and women around the country… Our choices this election come too late for Scott, although I hope that my friend from tiny Silverton, Ore., who somehow beat the odds so many times already in his life, will also beat this cancer. The election has the potential to help save the lives of many others who don’t have insurance.” Read more…

 

 

The Controversy Behind Our Nation’s Meningitis Outbreak

Our nation’s current meningitis outbreak has many people talking about two things: compounding pharmacies and lawsuits.

As of today, the Center for Disease Control has reported that 14 people have died in 170 cases of the outbreak which was caused by a steroid injection used for back pain. The contaminated vials were made by the New England Compounding Center in Framingham, Massachusetts, who recently recalled the products and shut down all operations

With nearly 14,000 people who may have been exposed to the steroid, the controversy has already sparked an investigation by the U.S. Food and Drug Administration and scrutiny about whether compounding pharmaceutical products is even legal.

A Forbes article “The Meningitis Outbreak: What Can Compounding Pharmacies Do Next?”, addresses many of these concerns about why compounding may cause more risks than benefits.

The Food and Drug Administration (“FDA”) explains that compounding “is an age-old practice in which pharmacists combine ingredients to create unique medications that meet specific needs of individual patients.” While the FDA has recognized that “pharmacy compounding is a vital service that helps many people,” they give a very ambiguous definition as to whether this practice is safe.

One patient who had received the injection is suing the firm, saying she is experiencing symptoms of meningitis and this may just be the first wave of lawsuits over the deadly outbreak. The FDA has become  increasingly concerned about the dangers from compounding over the past few years for two reasons. First, some companies allegedly engage in the large-scale production of drugs under the guise of compounding. Such companies, in the FDA’s eyes, are acting like manufacturers, but often without complying with the regulations requiring good manufacturing practices.

Thousands of these pharmacies so play a critical role in providing custom drug mixtures and hard-to-find compounds that might otherwise be unavailable to doctors and their patients. But a proliferation of compounding operations and federal oversight of these manufacturing regulations has obviously created a major national scandal. The article’s author, Richard Levick states:

“In a debate where liberals like Markey simultaneously deplore “the magnitude of sales”by the New England Compounding Center, it’s hard to know if this industry, caught in an ideological cross-fire, has any friends left.

The best way out of any such reputational cul-de-sac is to hit hard on the value that your company or industry provides even as you fully cooperate in efforts to remediate the problems you’ve caused. If you deserve to survive, the public benefits will palpably outweigh the liabilities in the court of public opinion.

The compounding pharmacy industry knows what those benefits are and what they’ll continue to be for quite some time to come. The industry has duly pointed out that drug companies cannot manufacture every medication that’s needed; that the compounders are filling a critical gap in our healthcare system; and that compounding pharmacists are steadfastly working with hospitals and doctors to help meet a prescription drug shortage of near-crisis dimension.” Read More…

More Doctors Frustrated with New Regulations & Health Policy

With an excess of new regulations, pressure from the new health care model, and a decline in clinical independence, nearly three-quarters of physicians are pessimistic about the future of the healthcare profession.

According to a new report by The Physicians Foundation, nearly half of the 14,000 doctors who were surveyed say they plan to cut back on hours, retire, see fewer patients, work part-time, transition to a concierge model or seek a non-clinical job in health care. Sixty percent would retire today if they could, compared with 45% in 2008. And if this trend continues, by 2016, it would equate to the loss of 44,250 full-time physicians.  Read More…

The American Medical News article, “Will a ‘Silent Exodus’ from Medicine Worsen Doctor Shortage?” explains that changes in the health industry have doctors feeling overrun, overburdened, and overtaxed.

The vice president of The Physicians Foundations said:

“It is clear that the introduction of nearly 30 million new patients into the U.S. health care system through health care reform, added to the already growing physician shortage, will have profound implications for patient access to medical care.”

The survey also showed the top reasons why doctors say the profession is in decline:

  • 79.2%: Too much regulation/paperwork
  • 64.5%: Loss of clinical autonomy
  • 58.6%: Physicians not compensated for quality
  • 54.4%: Erosion of physician-patient relationship
  • 45.9%: Money trumps patient care
  • 43.7%: Scope of practice encroachment
  • 6.9%: Too many part-time doctors

Data from “A Survey of America’s Physicians: Practice Patterns and Perspectives,” Physicians Foundation, Sept. 21 (See site)

Unfortunately, these results are not surprising. Another recent study published in the Archives of Internal Medicine surveyed 7,288 physicians in June 2011 and found that nearly 1 in 2 U.S. physicians report at least one symptom of burnout, with doctors at the front line of care (family medicine, general internal medicine, and emergency medicine) particularly vulnerable.

The findings showed that the doctors burnout rate is significantly higher than the general working population. Although physicians agree the current system is in trouble, the survey showed they were divided as to how to fix it. For the sake of both the future of the medical professionals and our nations patients, it’s clear that radical change is needed.

DEA Crackdown Makes Prescription Drugs Harder to Find

Florida officials displayed prescription drugs that were surrendered to the state by pain clinics on Aug. 15. Photo credit Tim Chapman/Miami Herald, via Associated Press

In an effort to curb Florida’s painkiller epidemic, the Drug Enforcement Agency (DEA) cracked down on Florida pharmacies last month, making prescription opioids increasingly difficult to find for patients.

The Wall Street Journal article, “Making the Pharmacy Crawl,” explains the pressure that pharmacists and doctors have been under to regulate opioid prescriptions and how it has caused more tension for patients.

While the DEA had hoped these efforts would force pharmacists and physicians to exercise more caution, the issue conflicts with doctors and patients who legitimately need the painkillers. The author, Timothy Martin stated:

“Several states now make doctors criminally liable and revoke their licenses for writing prescriptions for painkillers that lead to overdoses, prompting many to stop prescribing them at all. Other states have tightened regulation of pain clinics, forcing so-called pill mills to close but leaving people in need of pain medications with fewer doctors.”

The term “pharmacy crawl”  has recently been used by chronic pain patients in Florida who must now travel around town to get their prescriptions filled. Many pain patients believe there is a precription shortage, but the DEA says the decrease in opioid prescription availability could be a number of factors, including pharmacists simply being more cautious.

The president of Physicians for Responsible Opioid Prescribing, Dr. Andrew Kolodny believes the regulation is necessary to help mitigate the diversion of controlled substance and make wholesalers and pharmacies more responsible. He stated:

“The efforts to crack down on pills mills and irresponsible pharmacies and wholesalers are really appropriate and necessary… These groups pointing at the DEA and others should look in the mirror. They only have themselves to blame for the prescription-drug epidemic.”

Until recently, the state of Florida had played the role of our nations “Pill Mill” capital and was known for having the worst Drug Monitoring Systems in the country. Frequented by drug addicts, corrupt physicians and pharmacists, and drug traffickers, it’s no wonder why the DEA honed in on Florida’s top drug wholesalers.

While it is unfair that legitimate chronic pain patients must suffer on behalf of those who abuse opioids, the fact is our nations prescription narcotic problem is killing millions each year, with a death toll now exceeding those of heroin and cocaine combined.

With hopes of finding a balance between monitoring improper prescription and maintaining patient access to these drugs, the National Alliance for Model Drug Laws, are working with state officials to find a solution to the current “pharmacy crawl” issue. Read More…