Health Care Reform Sets the Standard Under the Federal Anti-Kickback Statute, But How Much Longer Will It Apply?0

17 No. 4 Westlaw Journal Health Care Fraud 1

October 12, 2011 — Commentary

Craig B. Garner, Esq.

Copyright © 2011 Thomson Reuters — Reprinted with Permission

Introduction

Under its aegis, the 2010 Patient Protection and Affordable Care Act, more commonly referred to as Health Care Reform, Pub. L. No. 111-148, clarified the criminal-intent requirement under the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b.

Before PPACA, federal courts applied different standards of intent, both general and specific, in determining the existence of violations under the AKS. Section 6402(f)(2) of PPACA amends the AKS by stating, in part:

With respect to violations of this section, a person need not have actual knowledge of this section or specific intent to commit a violation of this section.

Like it or not, congressional design is clear, and this general-intent threshold now serves as the national standard for the AKS after PPACA. While constitutional scholars may take aim at this seemingly benign amendment when they eventually tire of health care reform’s individual insurance mandate, health care and criminal law practitioners are better served by understanding the historical landscape leading up to Section 6402(f)(2). By tracing the evolution of the AKS, as well as the companion False Claims Act, 31 U.S.C. § 3729, and the Ethics in Patient Referrals Act, 42 U.S.C. § 1395nn (more commonly referred to as Stark I and Stark II), practitioners may have a stronger perspective with which to offer their clients advice within the rapidly changing climate of health care reform, rather than relying upon cautionary missives that speak to this watered-down standard of scienter.

Some legal history

Actus non facit reum nisi mens sit rea. (“The act is not culpable unless the mind is guilty.”) [FN1]

With a few exceptions, historical discussion of criminal law has tended to combine bad actions with a previously existing desire to effectuate the same. Most often in the context of ordinary, visible crimes such as murder, battery, robbery, arson, etc., a common condition precedent to conviction for such offenses was specific intent. [FN2] This mental element exists as a subset within two separate and distinct types of crimes: those prohibited by statutory authority (malum prohibitum, such as parking regulations, copyright laws and the tax code), and those plainly in violation of society’s standards (malum in se, such as rape and murder). … Read more →

Facebook and EHRs: A Very Fine Line Just Got Even Finer0

This article first appeared on iHealthBeat.org.

Americans love their privacy. And yet, as the ever-increasing trend of social networking illustrates, they also love to share the facts of their lives. As a result, defining privacy can be tricky in this modern age and often depends on the venue in which information is presented and the form it takes.

In today’s world of electronic health records, straddling the fence between harmless information and sensitive data is no longer such an easy task, and the repercussions for the slightest transgression can be severe.

On August 22, HHS issued a press release challenging software developers to create new Facebook applications to assist in emergency preparation efforts. If Facebook was a nation, its “population” would be more than double that of the United States. If online minutes for Facebook users were the functional equivalent of “dollars spent,” the social network’s estimated $84 trillion in annual “spending” would top the collective gross national products of all nations across the globe, even if the U.S. or European Union were counted twice.

While Facebook is a great way to stay connected to friends and family, it also can blur the line between privacy and the public domain. With a few quick clicks you may come to learn that Susan is at the coffee shop with Billy, Milton is attending a marketing seminar, or David is recovering nicely from a recent appendectomy at a hospital in Florida.

While Facebook might be given free rein to spread news of David and his recently removed appendix, other mediums must proceed with caution. If someone from David’s hospital was to leak his news, the hospital would face great scrutiny because health care providers are bound by law to obtain in advance David’s express, written authorization to publicly disclose details about his physical well-being. This is true even if said metadata were common knowledge among David’s 268 Facebook friends. … Read more →

Will Health Care Reform Survive Debt Ceiling Legislation?0

This article first appeared on Becker’s Hospital Review.

Contrary to media headlines closely monitoring the lower- and mid-level federal courts as they opine on the individual insurance mandate, the United States Judiciary Branch may have little impact on the future of President Barack Obama’s 2010 Patient Protection and Affordable Care Act. As fascinating as the legal ramifications may be, the ways in which the Commerce Clause or the Necessary and Proper Clause impact the constitutionality of healthcare reform’s most notorious provision of late could have little meaning if the government fails to pay a few utility bills and the congressional lights go dark.

While the importance of judiciary participation in this historical debate should not be discounted, the U.S. healthcare system must first and foremost be concerned with self-sustainability, especially in light of recent issues concerning our credit rating as a nation. … Read more →

The Wild West Sits One Out: AB 52 is delayed until 2012 as California backs down to health insurance company interests0

As expected, the 2010 Patient Protection and Affordable Care Act (PPACA) has had a dramatic impact on the American health care system. One of the more admirable objectives deeply entrenched in health care reform is the establishment of a clear and understandable infrastructure so that its many moving parts and pieces can seamlessly coexist under proper supervision. To this effect, at the end of 2010, the federal government published proposed regulations addressing health insurance rates, including strict disclosure and careful review of any significant price adjustments by insurers.

Focusing on the exorbitant 131 percent increase in health insurance premium rates for families since 1999, these reform-based regulations required all rate increases of 10 percent or more to be publicly disclosed and justified as of 2011. With an eye to the future, PPACA further dictated that by 2012, each state shall be responsible for setting and enforcing its own rate threshold to reflect appropriate cost trends and other meaningful date when reviewing future rate hikes. For states that fail to establish such a system of oversight, either by design or due to lack of resources, the U.S. Department of Health and Human Services (HHS) will step in and satisfy the intent of the legislation.

Read more →

Preparation Does Not Guarantee Perfection0

This article first appeared on California Healthcare News.

California has always found its way into the public spotlight, and 1975 was no exception. That is the year in which Jerry Brown became the state’s 34th governor, Nolan Ryan started the season for the California Angels, President Ford survived an assassination attempt in Sacramento, actors Jon Voight and Marcheline Bertrand gave birth to their daughter Angelina Jolie Voight in Los Angeles, and the state’s Medical Injury Compensation Reform Act of 1975 (MICRA) was passed.

At its core, MICRA was the end result of efforts to save California’s physicians from the fallout of a multitude of lawsuits, runaway jury verdicts, and draconian responses by insurance liability companies. With its $250,000 cap on non-economic damages in medical malpractice litigation, MICRA made history as its backers trumpeted the salvation of medicine in California. Controversial from the day Governor Brown first signed it into existence, MICRA continues to face challenges these 36 years later. For better or worse, however, MICRA addressed a critical issue and assuaged what were at the time very real fears that issues of liability and catastrophic jury verdicts would bring California’s medical system to a halt.

California’s hospitals are not alone in their need to proactively address situations involving unforeseen events. In this present era of health care reform, providers across the nation have an even greater abundance of legal issues on which they must focus their attention. For example, in the not too distant past a new concern appeared on the horizon some 2,700 miles from Sacramento. August 2005 saw Hurricane Katrina wreak havoc throughout southeastern Louisiana, with a death toll in excess of 1,800 and an $80 billion price tag, to say nothing of the sociological and environmental collateral damage that quickly followed.

Once the storm had passed and the dust had begun to settle, a frightening discovery at Memorial Medical Center in New Orleans captured the nation’s attention anew and resonated in the hearts and minds of every hospital administrator across the nation. Forty-five Memorial Medical Center patients died from the Hurricane, a number greater than any other New Orleans hospital, and blame was quickly directed to the hospital and its failure to provide for its community in an emergency situation. … Read more →

Instructions Never Included0

“Man cannot discover new oceans unless he has the courage to lose sight of the shore.”

— André Gide, French author

This article was first published on the PBS affiliated website This Emotional Life.

I have decided at last to forgo my search for instructions. Though it was nearly a decade ago that I first hoped to uncover an operational manual at work during my first tenuous days in an unfamiliar hospital environment, such guidance always escaped my discovery.

Seven months ago a new job of sorts presented itself to my wife and me, and not surprisingly, this owner’s manual also turned up missing. The resultant experiences brought about by new fatherhood have only served to reinforce my decision to trust my instincts from this point forward, as while there is an abundance of literature that purports to bridge such gaps in both professional and personal knowledge, I have yet to encounter any crisis brimming with patience, be it related to emergency department protocol or an unexpected and unexplainable late night tantrum.

In my professional role as health care attorney and consultant, I have come to grips with the fact that the federal government may not publish an “executive summary” covering all 2,700 pages of last year’s Patient Protection and Affordable Care Act (PPACA, more commonly referred to as health care reform) anytime soon.  … Read more →

Looking Back to Move Ahead: Leading Hospitals Through Fast-Paced Change (Becker’s Hospital Review)0

The article was first published August 26, 2011 on Becker’s Hospital Review (written by Molly Gamble).

Healthcare executives might remember time moving a bit more slowly before March 23, 2010. That was the day President Obama penned his signature, supposedly letter by letter, onto the Patient Protection and Affordable Care Act. The average workday for healthcare or hospital CEOs was probably filled with slightly different concerns or agendas before that moment. Since then, though, the industry has been flung into fast motion to accommodate the policy changes mandated in that 2,700 page bill along with its larger overarching themes that are shaping modern-day healthcare.

For the rest of the article, visit the Becker’s Hospital Review Website.

PBS’s ‘This Emotional Life’: Medicine By the Numbers

PBS’s “This Emotional Life”: Medicine By the Numbers

Lewis Carroll wrote: “If you want to inspire confidence, give plenty of statistics. It does not matter that they should be accurate, or even intelligible, as long as there is enough of them.”

When people are first told that a loved one is in the hospital, they want answers. Straight answers. And they want them fast.

But oftentimes in today’s medical centers, what patients and family members alike are met with is numbers: Hypotheticals, probabilities and percentages. When combined with complex medical jargon, this can quickly lead to confusion and uncertainty, as those involved must make sense of the stats before they can understand the state of the patient’s condition. Without the proper frame of reference, this type of information can quickly exacerbate fears and increase emotional distress. Rather than serve as beacons to shed light on a patient’s chances, these figures quickly become barriers to the truth. For many of us, the numbers are to be feared, not followed.

Still, whether we like it or not, playing the percentages is a medical necessity. In the modern age, health care is all about the bottom line. As technology advances and life expectancy increases, today’s treatment options become more and more focused on the probabilities of success or failure. From prenatal care to geriatric services, every patient ultimately wants to know one thing: “Where do I stand?” More and more, the answer is delivered as a number, culled from experience, testing, and appropriate clinical research trials. This often leaves the physician to mediate between patient and procedure, as he or she attempts to present new information in such a way that those involved can both understand and take comfort from that most dispassionate of messengers, the statistic.

The numbers themselves are not to be blamed. At the risk of making modern health care sound like a sports bar in Las Vegas, the purpose of statistics in a medical environment is to give the facts about a patient’s condition in black and white, which, if not done humanely, can seem lacking in compassion. The key to recognizing the value of such numbers is to use them as guidelines, not ultimatums.

Properly used, statistics perform a dual function: When correctly interpreted and explained, these numbers can act as a security blanket, breaking down frightening uncertainties into hard facts in which patients can wrap themselves during a time of emotional upheaval, while also providing a solid understanding of treatment options and outlooks. From a doctor’s perspective, they stand as a buffer, protecting the physician from being forced into the unrealistic role of savior, no matter what the condition. In their way, percentages help to reinforce the idea that nature, and not the doctor, will ultimately make the final call as to a patient’s future. Such impartiality goes a long way toward strengthening the doctor-patient relationship, especially when the prognosis is not as good as a patient might have expected.

Numbers can be persuasive to those patients faced with making important yet difficult lifestyle changes or deciding upon end-of-life treatments. For patients diagnosed with serious illnesses and their families, much of today’s medical data provides hope. For example, according to the information available at the end of 2009, life expectancy in the United States reached an all-time high in 2007 — 77.9 years (75.3 years for men and 80.4 years for women). Between 2006 and 2007, rates dropped for nearly half of the leading causes of death in the United States (cancer, heart disease, stroke, hypertension, accidents, diabetes, homicides and pneumonia), reaching a new low of about 0.76 percent of the population (760.3 deaths per 100,000 people). That is approximately one half the rate from 1947. Once fatal illnesses are slowly being reclassified, provided the patient heeds the warnings found among the numbers and takes the appropriate steps to live in a healthier manner.

On the other end of life’s spectrum, many newly pregnant couples become surprisingly imaginative upon first hearing their good news and spend much time contemplating the worst. To calm the parents’ nerves (and to protect the doctor’s interests), it is now standard practice to administer a series of tests to assess the baby’s health throughout development. Then end result of most of these tests comes back in numbers. Statistics again.

Without debating the ethics and morality of abortion, which is not a doctor’s role, many of these tests seek to ascertain the health of the fetus and predict the odds of certain birth defects such as Down syndrome, trisomy 18, or trisomy 13. The number of things for a pregnant couple to worry about can be staggering, yet doctors are often obligated to advise them of the chances in advance. For example, in North America, 1 in 260 females carry the chromosome for Fragile X (also known as “Martin-Bell”) syndrome, a genetic disorder that results in an array of physical and mental limitations, ranging from severe to mild in manifestation. Likewise, 1 in 149 Ashkenazi Jewish individuals carry the gene for Nemaline Myopathy, a neuromuscular disorder that causes muscle weakness of varying severity. In its most potent form, Nemaline Myopathy results in death after just a few years. By incorporating these tests with such relevant factors as the age and overall health of the mother and the genetic background of each parent, doctors can provide a statistical model on which to gauge the probability of the baby’s being born to normal health. This can provide parents with peace of mind if the chances of defects are low, or the opportunity to prepare themselves or consider their options if the outlook is not favorable.

At least one reason behind the surge in statistical diagnosis is the continued rise in medical malpractice claims. Having been forced into the role of omniscient healer as a result of advances in diagnostic testing, doctors must now use this same technology to cover themselves in the event of a statistical improbability. A recent study by the American Medical Association concluded that “defensive medicine” (defined as medicine relying upon diagnostic and other therapeutic measures to safeguard against malpractice claims first, and the health of the patient second) increase health care costs by as much as $150 billion each year. To be sure, throwing the title of statistician into a doctor’s medical bag of magic tricks does not help to further the doctor-patient relationship.

There is no numeric substitute for direct and clear communication between a doctor and patient. That said, making sense of medical statistics can go a long way in helping a patient understand diagnosis, prognosis and treatment. If you or a loved one has been diagnosed with a potentially life-threatening illness, your decisions about treatment can often be linked to “quality of life” concerns. No matter what age, patients want answers to certain questions, often combined with supporting statistics, such as:

  • How will this disease affect my life on a day-to-day basis
  • Is this disease terminal, or if left untreated, will it become terminal?
  • How will the treatment affect my life on a day-to-day basis?
  • How will the disease, treated and/or untreated, alter my life expectancy compared to my anticipated decline in health as I age?

It is important to remember that statistics are numbers, plain and simple. While numbers may not lie, they have no bedside manner and can be interpreted in a variety of methods and made to suit many arguments. The best way to know where you or your loved one stands is to discuss your situation clearly and openly with your doctor, taking into consideration the big picture as well as the percentages.

This Emotional Life is a two-year campaign to foster awareness, connections and solutions around emotional wellness. Join our community at www.pbs.org/thisemotionallife.