0.44% of NFL Brains

When The New York Times reports that 110 out of 111 NFL brains (99.09%) have chronic traumatic encephalopathy (CTE), everyone pays attention. Mothers worry about their kids. Some worry about their jobs. Senate subcommittees investigate. The Times article covers Dr. Ann McKee’s recent article in the Journal of the American Medical Association, “Clinicopathological Evaluation of Chronic Traumatic Encephalopathy in Players of American Football” (JAMA. 2017;318(4):360-370) in dramatic fashion, illustrated with pathology slides of tissue samples from the brains of former football players and anecdotal information about them. Such claims are certain to be fuel for CTE litigation and cries to ban tackle football.

Let’s put this in perspective. About 25,000 men have played American professional football. So, 110 is roughly 0.44%. Even if the real number is double, the outcome remains a statistical nonentity.

In all fairness, the study points out some of its limitations; for example, “Ascertainment bias associated with participation in this brain donation program.” Inclusion was based entirely on exposure to repetitive head trauma eliminating any form of “control” group, a necessary element of any scientific study. The authors also disclose that “public awareness of a possible link” between head trauma and CTE “may have motivated” some participants. Finally, the authors acknowledge that the study is not representative of the population of all American football participants, as most play only at the youth or high school level, whereas the majority of the donors played at the professional level. The study data somewhat illustrates that point: CTE was found in none of two pre−high school participants and three of 14 high school participants (21%).

Breaking It Down

The 800-pound gorilla in this room is suicide. Suicide among former football players gets major media attention (Junior Seau and Aaron Hernandez) and has spawned a cottage industry of CTE litigation against every level of the sport from NFL down to Pop Warner. The study tries to correlate neuropathology with “clinical observations” − information drawn from “retrospective interviews” with family members of deceased donors. Observations are grouped as cognitive, behavioral or mood or both, and signs of dementia. Suicide was identified as the cause of death in 10% of the study group. “Suicidality” (ideation, attempts or completion) is identified among 33% of the study group. Some might conclude that if you play football you are 33% more likely to contemplate or attempt suicide and 10% more likely to succeed.

In fact, the rate of suicide mortality among retired NFL players is substantially lower than in the general population. An investigation performed at the National Institute for Occupational Safety and Health (NIOSH) and published in 2016 (Lehman, et al.) found that among players retired since 1987, the suicide rate is 6.1 / 100,000. Among players retired since 2005, it’s 12.5 / 100,000. Among average American men, the rate since 2014 is 20.1 / 100,000. One would conclude that since 2005, NFL players are 48% less likely to commit suicide than the general population, and since 1987, 70% less likely. The study covered those who played for five years or more.

Of note, drugs are assessed by standardized mortality ratio – the increase or decrease in mortality with respect to the general population. “If playing in the NFL (for a minimum of five seasons) were treated like taking a drug, it would reduce the standardized mortality (measured 30 years later) by half!” Samadani, Brain Injury and Football, Reality v. Perception. THSCA presentation, 2016.

Similar studies have been done at the college level where the NCAA maintains a robust database. A nine-year study published in October 2015 (Rao, et al.) observed that as against a rate of 12 / 100,000 among 18−22-year-old non-college individuals, the suicide rate among college students was 7.5 / 100,000. Among male NCAA athletes, the suicide rate was 2.25 / 100,000.

Another study dispels the notion that CTE is a path to neurological deficit. Published in Acta Neuropathol, “Histological Evidence of CTE in a Large Series of Neurodegenerative Diseases” (Ling, et al., 2015) observed that (1) CTE prevalence in people with neurodegenerative diseases (11.8%) was the same as in controls (12.8%); (2) patients with CTE died at a mean age of 81 years and “most positive cases [were] likely to be clinically asymptomatic”; and (3) CTE is found under the microscope in equal proportions of healthy, normal, asymptomatic people as it is in people with dementia and other diseases. For those worried about doing the right thing by their kids, a study published in December 2016 in Mayo Clinic Proceedings (Savica, et al., “High School Football and Risk of Neurodegeneration: A Community-Based Study”) found that among 438 football players followed for 50 years, the risk of dementia was the same as for members of the chorus, glee club or band.

Facts and Findings

Fortunately, in court science matters. The notion that football causes CTE has been rejected by at least one United States District Court, the Eastern District of Pennsylvania, and the Third Circuit Court of Appeals. See In re NFL Players Concussion Injury Litig., 307 F.R.D. 351 (EDPA, 2015), aff’d 821 F.3d 410 (3d Cir. 2016). Judge Brody’s key findings, based on current scientific knowledge and affirmed by the appellate court, negate causation: (1) the study of CTE is nascent, and the symptoms of the disease, if any, are unknown; (2) medical research has not reliably determined which events make a person more likely to develop CTE; and (3) research has not determined what symptoms individuals with CTE typically suffer from while they are alive. In re NFL Players Concussion Injury Litig., 821 F.3d at 441.

The point: Media should not lead science. The health and psychosocial benefits of athletic activity at all ages far outweigh any perceived risk. As parents, we should encourage healthy activity. As professionals, we need to peel back what the media pushes, read the literature and understand the fundamentals.

This post was written byAnthony B. Corleto of Wilson Elser Moskowitz Edelman & Dicker LLP.
For more legal analysis check out The National Law Review.

Potential Obstacle To Effective Internal Compliance Reporting System? The False Claims Act

Yes, you read the title of this post correctly.  Under the False Claims Act, a whistleblower is not required to report compliance concerns internally through a company’s internal reporting system before filing a “qui tam” court action.  Indeed, the False Claims Act — with its potential “bounty” of 15 to 30 percent of the government’s recovery — may actually encourage employees to file suit in the first instance, to qualify as an “original source,” and bypass the organization’s reporting system altogether, thereby frustrating a key component of an effective compliance program.  Whistleblower organizations have recently gone so far as to discourage individuals employed by health care providers from bringing compliance concerns directly to their employer so that they can get a share of the government’s recovery.

A provider or other entity participating in the Medicare or Medicaid programs, however, can mitigate that risk through, among other things, employee training and disciplinary policies encouraging good-faith reporting and the promotion of a culture of compliance, including setting the right “tone from the top.”

Internal Reporting System.  The cornerstone of any effective compliance program is developing and implementing a robust internal reporting system that employees can use to raise any compliance concerns on an anonymous basis.  Among other things, when compliance concerns are brought to the attention of the organization’s compliance personnel, the organization can investigate the issue and take appropriate steps to prevent or remediate any continued potential misconduct.  Likewise, having such a system in place may serve as a defense to liability under the False Claims Act.  Even if improper billing is found to have taken place, evidence that the organization has an effective, anonymous internal compliance reporting system may show that the improprieties were not the result of deliberate indifference or reckless disregard for such practices.

False Claims Act.  Plainly, the risk of treble damages and per claim penalties under the False Claims Act is a powerful incentive for a health care organization to implement an effective compliance program.  What is more, the provision for whistleblower awards under the False Claims Act can be an effective tool to aid the government in detecting and preventing overpayments by Medicare and Medicaid to fraudulent operators and other bad actors.  By allowing whistleblowers to file relator actions under seal and potentially share in any of the government’s recovery — as well as to seek damages for any retaliatory employment action — the False Claims incentivizes employees in the health care industry to come forward with information about fraudulent billing, without the fear of reprisal.

The Tension Between The Two.  At the same time, a whistleblower’s potential recovery can operate as a countervailing disincentive for an employee to report compliance concerns internally.  That is because under the False Claims Act, a qui tam relator is entitled to a “bounty” only if the individual is the “original source” of information to the government about the improper billing practices that are the subject of the relator’s action.  On the other hand, if an employee does dutifully report a compliance concern internally through the organization’s reporting system, and the organization itself reports any overpayments to the government or remediates the misconduct itself, the whistleblower may be unable to sue and recover any “bounty.”  As noted earlier, this point is not lost on the relator bar.

Overcoming The Tension.  How does a provider overcome the entreaties of the relator bar, along with the incentives under the False Claims Act whistleblower provisions, to convince employees with compliance concerns to avail themselves of the company’s internal reporting system?  At the outset, the reporting system may be both effective and credible to instill  confidence in the system so that employees will take full advantage of it – that is, the organization must deliver on its promise of anonymity and protection of good-faith reporting and must follow through on a timely basis with a thorough investigation and meaningful corrective action, if indicated.  Further, a robust reporting system, standing alone, will not be effective unless all other elements of an organization’s compliance program are working effectively as well, starting with a “culture of compliance,” reinforced by the executive team and management, and continuing with inservice compliance training, underscoring the importance of timely reporting and the anonymity and other protections afforded to reporting employees.

Likewise, the organization must have personnel and disciplinary policies that reward good-faith reporting and punish compliance lapses, both for engaging in unlawful conduct as well as for failing to report it.  That said, taking any disciplinary action against an employee who files suit as a relator, without ever having reported the compliance concerns in breach of the employee’s duties, is fraught with the risk that the termination or other action will be challenged as retaliation for filing the False Claims Act action, and that the cited ground — failing to report   — is allegedly merely pretextual.

However, with the proper messaging and training, coupled with a robust anonymous reporting system, the company can give its employees good reason to “do the right thing” and report compliance concerns to the company in the first instance, despite the lure of a False Claims Act bounty.

This post was written byBrian T. McGovern of Cadwalader, Wickersham & Taft LLP.
For more legal analysis check out the National Law Review.

Rethinking Transparency – Inpatient Prospective Payment System Final Rule Rescinds Proposed Survey Disclosure Rule

The 2018 Inpatient Prospective Payment System (IPPS)/Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) proposed rule, published in April 2017, contained a controversial provision that would have required accrediting organizations (AOs) that confer deemed status (such as The Joint Commission and DNV) to make all survey reports and acceptable plans of correction publicly available on their websites within 90 days of issuance (Proposed Transparency Rule). While the proposed rule cited the goal of improved transparency and enhancing patient health and safety, hospitals and other health care facilities that rely on AOs for deemed status voiced significant concerns about the unintended consequences of such disclosures, including providing an AO-slanted view of events, placing health care facilities on the defensive regarding corrective actions, the inability to correct misstatements in survey reports, and the risk that the public would not understand the survey process and become unreasonably biased against certain facilities. The Proposed Transparency Rule also garnered comment as Centers for Medicare and Medicaid Services (CMS) does not require itself to make all of its survey reports publicly available in such a short time frame, and does not presently make full plans of correction for all health care facilities readily available to the public.

To the surprise of some in the industry, the 2018 IPPS/LTCH PPS final rule (Final Rule) released on August 2, 2017, withdrew the Proposed Transparency Rule in its entirety, for a reason entirely unrelated to the main arguments that had been raised: potential conflict with Section 1865(b) of the Social Security Act (Act). Section 1865(b) of the Act provides that:

The Secretary may not disclose any accreditation survey (other than a survey with respect to a home health agency) made and released to the Secretary by the American Osteopathic Association or any other national accreditation body, of an entity accredited by such body, except that the Secretary may disclose such a survey and information related to such a survey to the extent such survey and information relate to an enforcement action taken by the Secretary. See 42 USC 1395bb.

CMS indicated in the Final Rule that it was concerned that implementing the Proposed Transparency Rule would “appear as if CMS was attempting to circumvent” the Act by requiring the AOs to release their own survey reports—a concern that was sufficient for the Proposed Transparency Rule to be withdrawn.

Whatever the basis of the decision, AOs, hospitals and health care facilities must prepare for the next effort to make AO and CMS survey and plan of correction information readily available on-line—transparency may have been delayed by the withdrawal of the Proposed Transparency Rule—but it is on the way, like it or not.

This post was written bySandra M. DiVarco  of McDermott Will & Emery.
More legal analysis available at the National Law Review.

US Attorney’s Office in Chicago Announces Creation of Health Care Fraud Unit

Acting US Attorney Joel Levin says the new dedicated unit aims to bring “even greater focus, efficiency, and impact to our efforts in this important area.”

The US Attorney’s Office for the Northern District of Illinois recently announced the creation of a Health Care Fraud Unit—a team of five assistant US attorneys devoted to prosecuting all types of healthcare fraud cases, including fraudulent billing schemes and diversion of controlled substances.

The announcement came just days after the largest US Department of Justice national healthcare fraud enforcement “takedown” action against 412 defendants across 41 federal districts for the alleged participation in schemes involving over $1 billion in fraudulent healthcare billing. Fifteen individuals, including two Chicago-area licensed physicians, are facing federal criminal charges and potential Office of Inspector General (OIG) exclusion as a result of this action.

Nationwide, US Attorney offices have a major role in healthcare fraud enforcement. In Fiscal Year 2016 alone, US Attorney offices opened 975 new criminal healthcare fraud investigations and 930 new civil healthcare fraud investigations.[1] 

While the US Attorney’s Office for the Northern District of Illinois has a long history of prosecuting healthcare fraud cases, the creation of a dedicated unit within the office may have a number of quantifiable effects, including the following:

Rise in Criminal Investigations and Prosecutions. The dedicated unit, comprised of criminal prosecutors, will focus on the criminal prosecution of entities and individuals when the alleged healthcare fraud rises to the level of criminal culpability. As such, there likely will be a rise in investigative activity that includes attempted interviews of potential targets, subjects, or witnesses by government agents; the issuance of grand jury subpoenas; and the execution of search warrants.

In addition, the criminal prosecutors undoubtedly will work closely with government attorneys assigned to the civil division and—to the extent permitted in accordance with grand jury secrecy rules—share certain information with civil division attorneys.

Rise in Enforcement Investigations and Actions. With increased focus, resources, and the sharing of information obtained from criminal investigations, there also may be a rise in the number of civil investigative demands issued to companies in the healthcare industry that are suspected of fraud, waste, and abuse. The US Attorney’s Office for the Northern District of Illinois may become more proactive in its efforts—alongside the OIG—to increase the collection of civil penalties against healthcare organizations and executives.

Rise in Qui Tam Suits. With a dedicated Health Care Fraud Unit, the Northern District of Illinois may become a more attractive venue for whistleblowers seeking to recover under the False Claims Act for alleged fraud, waste, and abuse.

The new Health Care Fraud Unit will operate within the criminal division of the US Attorney’s Office for the Northern District of Illinois. Assistant US Attorney Heather McShain will lead the unit, and Assistant US Attorney Stephen Chahn Lee will serve as senior counsel.

For more Health Care news go to the National Law Review.


[1] See The Department of Health and Human Services and The Department of Justice Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2016.

This post was written by Tinos Diamantatos and  Eric W. Sitarchuk of Morgan, Lewis & Bockius LLP.

Eating Disorders are Mental Health Conditions Subject to Parity Law

The Departments of Labor, Treasury and Health and Human Services (Departments) continue to issue FAQs addressing the implementation of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA), as amended by the Affordable Care Act and the 21st Century Cures Act (Cures Act). The MHPAEA prohibits group health plans from imposing financial requirements and treatment limitations on mental health and substance use disorder benefits that are more restrictive than the requirements imposed on medical and surgical benefits. The Cures Act requires the Departments to solicit public feedback regarding how to improve required disclosures under the MHPAEA. The FAQs in Part 38 contain the same request for public comment that was in Implementation Part 34, and provide a draft model form that can be used by participants to request information from a health plan regarding nonquantitative treatment limitations (NQTL) that may affect their mental health and substance use disorder benefits, or to obtain documentation after an adverse benefit determination involving these benefits.

In addition, the FAQs provide guidance regarding eating disorder coverage. If a plan provides these benefits, FAQ-1 in Part 38 confirms that the coverage must comply with the MHPAEA. The guidance indicates that “eating disorders are mental health conditions and therefore treatment of an eating disorder is a ‘mental health benefit’ within the meaning of that term as defined by MHPAEA.”  Plans should be reviewed to determine whether financial requirements and treatment limitations placed on eating disorder treatment comply with the parity requirements under the MHPAEA.

This post was written by Sarah Roe Sise of Armstrong Teasdale LLP.

For more legal analysis check out the National Law Review.

Long-Term Effects of Nonfatal Drowning Cannot Be Accurately Predicted

According to the Centers for Disease Control and Prevention (CDC), from 2005-2014, an average of 3,536 fatal unintentional drownings occurred per year in the United States. Approximately one in five people who die from drowning are children 14 years old or younger; children one to four years old have the highest drowning rates.

For every death caused by drowning, five children receive emergency room care for nonfatal drowning injuries. Nonfatal drowning can cause hypoxic-ischemic brain injury that may result in long-term disabilities ranging from memory problems and learning disabilities to total loss of basic functioning (persistent vegetative state).

A recent review study found that neurocognitive outcome of children after drowning incidents cannot be accurately predicted from early examinations and treatment. In the study, researchers sought to:  a) report the main factors related to the outcome of drowned children, and b) present existing evidence of long-term neurologic outcome. While some injuries caused by near drownings become evident shortly after the incident, the evidence showed that the initial neurological examination may not reveal all of the long-term effects related to hypoxic brain injury in young children. Skills such as divided attention and executive functions may be negatively affected after a brain injury caused by a nonfatal drowning. Long-term follow-up of drowned resuscitated children should be undertaken.

The review study showed that the long-term outcome of survived drowning victims depends mainly on the severity of the initial ischemic brain insult, the effectiveness of immediate resuscitation with transfer to the ER, and on the post-resuscitation management in the hospital. The study noted that the most susceptible areas to ischemic injury are vascular end zones, hippocampus, insular cortex, and basal ganglia. With greater severity of hypoxic-ischemia, more extensive and global neocortical injury will occur.

Electroencephalograms (EEG) provide useful information to differentiate between patients with good and poor neurological outcome. However, the accuracy in predicting long-term neurological outcome is lacking. The increased use of neuroimaging techniques such as MRIs can add valuable information. The ability to see the degree of edema and brain swelling is better with an MRI than with a CT scan. But the fact remains that data on long-term follow-up and outcome are scarce.

This post was written by Bruce H. Stern of  Stark & Stark.

The Healthcare Executive’s Simple Guide to FMV For Attorneys, C-Suite, Compliance, and Physicians

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