Tag: health

FDA Toughens Enforcement of Homeopathic Products

FDA recently announced that it was taking two significant actions with respect to products marketed as homeopathic drugs, suggesting that increased enforcement related to these products is imminent. Homeopathy is a form of alternative medicine that is based on the idea that illnesses and their symptoms can be treated by small doses of ingredients that produce similar symptoms in healthy people.

First, the Agency has withdrawn Compliance Policy Guide (CPG) Sec. 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” The CPG was issued in 1988 and described an enforcement policy that permitted unapproved homeopathic drugs to be marketed if certain conditions related to labeling, ingredients, manufacturing, and other considerations were met. In withdrawing the CPG, the Agency observed that products that seemed to meet the criteria described in the CPG nonetheless caused or could have caused serious harm.

Second, the Agency has revised its draft guidance entitled “Drug Products Labeled as Homeopathic.” The revised draft guidance describes enforcement priorities for homeopathic drugs marketed without required approval. According to the revised draft guidance, these priorities include:

•Products with reports of injury that, after evaluation, raise potential safety concerns.  For example, MedWatch reports on other information submitted to the Agency can indicate or signal a potential association between the product and an adverse event, medication errors, or other safety issues.

•Products that contain or purport to contain ingredients associated with potentially significant safety concerns. For example, potentially significant safety concerns are raised by products that contain or purport to contain:

– An infectious agent with the potential to be pathogenic;

– A controlled substance, as defined in the Controlled Substances Act, 21 U.S.C. 812;

– Multiple ingredients that, when used in combination, could result in possible interactions, synergistic effects, or additive effects of the various ingredients; and,

– Ingredients that pose a risk of toxic, or other adverse effects, particularly when the ingredients are concentrated or in low dilution presentations (e.g., 1X, 2X, or 1C), or are not adequately controlled in the manufacturing process.

  • Products for routes of administration other than oral and topical. . . .
  • Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions. . . .
  • Products for vulnerable populations. . . .
  • Products with significant quality issues. . . .

The revised draft guidance stresses that “nothing in the FD&C Act exempts homeopathic drug products from any of the requirements related to approval, adulteration, or misbranding, including labeling requirements.” It further emphasizes that “any homeopathic drug product that is being marketed illegally is subject to FDA enforcement at any time.”

©2019 Greenberg Traurig, LLP. All rights reserved.

For more FDA regulations, see the National Law Review Biotech, Food & Drug law page.

NIEHS-Funded Research Finds that Graphene Shield Shows Promise in Blocking Mosquito Bites

On August 26, 2019, the National Institute of Environmental Health Sciences (NIEHS) announced that the results of an NIEHS-funded study show that graphene could provide alternatives to chemicals in insect repellant and protective clothing.  The study, “Mosquito Bite Prevention through Graphene Barrier Layers,” was published in the Proceedings of the National Academy of Sciences.

According to the abstract, the researchers hypothesized that graphene films may provide mosquito bite protection for light, fiber-based fabrics.  The researchers investigated the fundamental interactions between graphene-based films and the mosquito species Aedes aegypti through a combination of live mosquito experiments, needle penetration force measurements, and mathematical modeling of mechanical puncture phenomena.  The abstract states that “[t]he results show that graphene or graphene oxide nanosheet films in the dry state are highly effective at suppressing mosquito biting behavior on live human skin.  Surprisingly, behavioral assays indicate that the primary mechanism is not mechanical puncture resistance, but rather interference with host chemosensing.”

The researchers propose that the interference is “a molecular barrier effect that prevents Aedes from detecting skin-associated molecular attractants trapped beneath the graphene films and thus prevents the initiation of biting behavior.”  According to the abstract, placing water or human sweat on the external film surface circumvents the molecular barrier effect.  In this scenario, the abstract states, “pristine graphene films continue to protect through puncture resistance — a mechanical barrier effect — while graphene oxide films absorb the water and convert to mechanically soft hydrogels that become nonprotective.”

©2019 Bergeson & Campbell, P.C.
This article was written by Lynn L. Bergeson and Carla N. Hutton of Bergeson & Campbell, P.C.
For more environmental research, see the National Law Review Environmental, Energy & Resources law page.

DNA Information of Thousands of Individuals Exposed Online for Years

It is being reported that Vitagene, a company that provides DNA testing to provide customers with specific wellness plans through personalized diet and exercise plans based on their biological traits, left more than 3,000 user files publicly accessible on Amazon Web Services servers that were not configured properly.

The information that was involved included customers’ names, dates of birth and genetic information (such as the likelihood of developing medical conditions), as well as contact information and work email addresses. Almost 300 files contained raw genotype DNA that was accessible to the public.

Vitagene has been providing services since 2014 and the records exposed dated between 2015 and 2017. Vitagene was notified of the accessibility of the information on July 1, 2019, and fixed the vulnerability.

Copyright © 2019 Robinson & Cole LLP. All rights reserved.
This article was written by Linn F. Freedman of  Robinson & Cole LLP.

Hungry for Change: ASA and Government Target Junk Food Ads

With childhood obesity rates in the UK among some of the worst in Europe, the Government has set a national target to halve childhood obesity by 2030. Whilst the Government acknowledges that this is a multi-faceted problem, it has reported that evidence suggests that children’s exposure to advertising of products that are high in fat, salt and/or sugar (“HFSS”) contributes to their consumption patterns.

HFSS product advertising is currently subject to content and placement restrictions under the Committees of Advertising Practice (“CAP”) broadcast and non-broadcast codes of advertising (“Codes”); however, campaigners and industry bodies have raised concerns that adverts are not being targeted correctly and that the existing rules do not go far enough. The Advertising Standards Authority (“ASA”) and the Government have taken steps in recent months to address these issues, with the ASA launching a monitoring exercise on targeted ads and the Government consulting on options to reduce children’s exposure to HFSS ads.

The rules

Each of the Codes contains rules dealing with adverts that are directed at or feature children, as well as specific rules in relation to advertising HFSS products, whether directly or indirectly. The restrictions include:

  • a prohibition on the use of licensed characters and celebrities popular with children in ads for HFSS products where the ad is targeted at under 12s;
  • in relation to broadcast TV, a prohibition on HFSS products being advertised “in or adjacent to programmes commissioned for, principally directed at or likely to appeal particularly to audiences below the age of 16”; and
  • in relation to ads placed in children’s media, “HFSS product advertisements must not be directed at people under 16 through the selection of media or the context in which they appear. No medium should be used to advertise HFSS products, if more than 25% of its audience is under 16 years of age”.

ASA monitoring

Although compliance with the Codes by advertisers is generally high, the ASA recently published the results of a ‘compliance sweep’ that used online avatars to monitor ads for HFSS products that were served to children. Similar technology was used earlier this year to track brands that breached CAP’s gambling rules on advertising to under 18s, which we reported on in April.

The avatars replicated the browsing habits of children of various ages and collected information about HFSS adverts appearing on children’s websites and on YouTube. The monitoring exercise found that the vast majority of HFSS ads on children’s websites were being targeted correctly; however, potential issues were identified in relation to HFSS ads being served on YouTube.

Moving away from its typically ‘reactive role’, the ASA took proactive action to notify a number of non-compliant brands which were each required to take steps to prevent further breaches, including making improvements to their targeting approach.

Government consultation

Despite strong compliance by the industry, the Government is still considering further advertising prohibitions and earlier this year launched a consultation in which it sought views on options to further reduce children’s exposure to HFSS in broadcast and online media, including the introduction of a 9pm watershed. Other options included a ‘ladder’ system for advertising restrictions on broadcast TV, the strengthening of current targeting restrictions for online advertising and a mixed option for online advertising consisting of a watershed for video and additional targeting restrictions for other types of marketing.

Whilst the watershed proposals have received extensive support from campaign groups such as The Children’s Food Campaign (Sustain) and the Obesity Health Alliance, the ASA and the Institute of Practitioners in Advertising have both stated that the proposed changes would be ineffective and disproportionate, particularly given the high level of compliance with the HFSS rules in the Codes.

Steps to take

The ASA has stated that it will carry out further compliance sweeps in future, and so advertisers should take care to continue to comply with the Codes.

Anyone advertising in the area should also make use of any available tools which allow the targeting of ads so as to restrict children and young people from seeing adverts for HFSS products. Advertisers must also ensure that terms with their media buyers are sufficient to guarantee that targeting has been put in place correctly. As with labelling or other regulated industries such as financial services, agencies may wish to make clear that responsibility for compliance with these specialist rules lies with their clients (in particular if an assessment as to whether a product is indeed HFSS is required).

 

© Copyright 2019 Squire Patton Boggs (US) LLP

Five Unanswered Questions on the Medicare for All Act

On February 27, 2019, Representative Pramila Jayapal (D-WA) and more than 100 co-sponsors in the House of Representatives introduced the Medicare for All Act (HR 1384). The bill, like its predecessors, creates a single payer, government-funded health care program. The new program would cover enumerated medical benefits, prescription drugs, vision, dental, mental health and substance abuse services.

As expected, progressive House Democrats are using Medicare for All to message their position on coverage expansion heading into the 2020 election. The legislation threatens to expose divides in the Democratic Party, with some Democratic leaders publicly silent on the bill as the left flank of the party tries to advance the proposal. In previous years, other Democrats introduced competing proposals aimed at tackling coverage, including Medicaid and Medicare Buy-In approaches. Messaging the future of the Affordable Care Act (ACA), covering the un- and underinsured, and reducing costs promise to dominate the airwaves in the lead-up to the 2020 presidential election.

It is unclear whether Medicare for All will see a vote on the House floor, either as a whole or in its component parts. Even if the bill were to pass in the House, it is almost certainly doomed in the Republican-controlled Senate. Regardless of the bill’s fate, stakeholders should take this opportunity to prepare for forthcoming conversations about how to address the uninsured population and the rising cost of health care.

Many components of the bill are consistent with versions introduced in previous congressional sessions. There are many questions raised by the legislation: This +Insight focuses on five big ones for stakeholders to consider as they evaluate Medicare for All:

1. Is Medicare for All the Democrats’ “Repeal and Replace”?

Since the enactment of the ACA, congressional Republicans have run on “Repeal and Replace” as a counter message to the Democrats’ signature legislative achievement. When the balance of power shifted in Washington after the 2016 election, pressure intensified on Republican lawmakers to come up with an alternative to the ACA. Ultimately, efforts to repeal and replace the ACA failed legislatively, and efforts to modify the law have been piecemeal and primarily regulatory.

Similarly, Medicare for All and other single payer proposals have largely been Democratic messaging tools, with many of the details unspecified or unaddressed, and many aspects of the proposals ambiguous. If Democrats were to see a presidential victory in 2020, will they be in the same “dog that caught the car” position?

2. How much time is necessary to revamp the US health care system?

Medicare for All is a fundamental, sweeping policy change to the way the United States pays for health care. The legislation reorganizes nearly one-fifth of the nation’s economy. Rep. Jayapal’s proposal envisions a very quick transition to the new system—a two-year period, with certain individuals eligible to enroll in Medicare for All beginning one year after the date of enactment. Other proposals, including Senator Bernie Sanders’ (I-VT) Medicare for All plan, have contemplated longer transition periods (four years in the case of the Sanders plan). In interviews following the bill’s release, Rep. Jayapal stated that the swift transition was necessary because a longer transition period would provide perverse incentives in the marketplace.

As a messaging tool, the short transition period serves its purpose: to illustrate that the bill’s supporters are serious and are taking quick action to reform the health care marketplace. Practically speaking, however, if this or a similar bill were to make it across the finish line, the aggressive timeline could create additional challenges. To ensure success while preventing delay requires a delicate balance.

For example, when the ACA passed in 2010, states were mandated to expand Medicaid coverage and given a four-year transition period to make the necessary changes.[1] That was a far smaller expansion than the one envisioned by Medicare for All, and lawmakers provided twice the time to implement it. Nine years later, legal complications and administration changes mean the outlook is still murky. At the same time, if the transition is too long, advocates risk giving opponents time to pressure Congress for delays, as evidenced by the repeated delays and suspension of some of the taxes imposed by the ACA.

3. What might supplemental coverage look like?

Like previous single payer bills, this bill outlaws the sale of private health coverage that duplicates the benefits provided under Medicare for All. It similarly prohibits an employer from providing benefits to employees, retirees and their dependents. The bill also covers many services currently served by a supplemental market—vision, dental, hearing, long-term care and prescription medication, for example.

The bill contains two provisions, however, that leave open the potential for a private market to exist. First, the bill allows the sale of insurance for additional benefits not covered by the Act.[2] Second, like others before it, this bill leaves significant discretion to the Secretary of Health and Human Services regarding coverage for certain categories of services. If the Secretary promulgates rules and regulations that provide minimal coverage, could a private supplemental market thrive? If the Secretary goes the other direction, what would be left for the private market to profitably cover?

4. What is the role of the states?

Under this legislation, states may provide additional benefits for their residents, and may provide benefits to individuals not eligible under the Act at the state’s expense, provided that the state’s rules provide equal or greater eligibility and access than the single payer plan.

States thus could potentially treat Medicare for All as a floor and build policies to expand services and coverage within state lines. However, this would all be on the state’s dime. The bill effectively ends the Medicaid program, which is where many states have the opportunity to innovate with service and coverage expansion. What would states be able to accomplish without a federal matching rate?

5. What becomes of value-based purchasing?

The legislation would require the Secretary to establish a national fee schedule for items and services provided under the Act. The Secretary is required to take into account the value of items and services provided and amounts currently paid. The Secretary will negotiate annually the prices to be paid for pharmaceuticals, medical supplies, medical technology and equipment.[3]

The legislation sunsets all federal pay-for-performance programs and terminates value-based purchasing, including the merit-based incentive payment system, incentives for meaningful use of electronic health records technology, alternative payment models, hospital value-based purchasing, payment adjustments for health-care-acquired infections, the Medicare Shared Savings Program, independence at home and the hospital readmissions reduction program.[4]

The bill’s approach of shifting back to fee-for-service payments (as evidenced by the programs the bill would eliminate) is interesting, coming as it does after years of congressional, administration and private market efforts to move toward a value-based payment system. Do the bill’s authors envision reinstituting these types of programs once the new system settles? Do the authors believe these programs are no longer necessary given the global payments approach included in the bill?

Conclusion

There will be ample opportunities to draw out the consequences (intended and unintended) of implementing this sweeping change in how health care is provided in the United States. The House Rules and Budget Committees have already confirmed intentions to hold hearings on this bill. The House Energy and Commerce and Ways and Means Committees, which notably are the committees of jurisdiction, do not have immediate plans to hold hearings on the bill as a whole, but they are already discussing specific policy provisions. The Democratic presidential primary will certainly keep this issue at the forefront of health care policy in 2019 and 2020.

[1] In National Federation of Independent Business v. Sebelius, the Supreme Court of the United States ruled that Congress could not require states to expand the Medicaid program. Medicaid expansion then became an option for states.

[2] Section 107.

[3] Section 616.

[4] Section 903.

 

© 2019 McDermott Will & Emery
This post was written by Mara McDermott and Rachel Stauffer from McDermott Will & Emery.

HHS Proposes to Revise Discount Safe Harbor Protection for Drug Rebates

On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify a regulatory provision that had previously protected certain pharmaceutical manufacturer rebates from criminal prosecution and financial penalties under the federal Anti-Kickback Statute.

Specifically, the Proposed Rule would exclude from “safe harbor” protection rebates and other discounts on prescription pharmaceutical products offered by pharmaceutical manufacturers to Medicare Part D plan sponsors or Medicaid Managed Care Organizations (MCOs), unless the price reduction is required by law (such as rebates required under the Medicaid Drug Rebate Program). The proposed exclusion would apply to rebates offered directly to Part D plan sponsors and Medicaid MCOs, as well as those negotiated by or paid through a pharmacy benefit manager (PBM). HHS stated that it does not intend for the revisions in this Proposed Rule to negatively impact protection of prescription pharmaceutical product discounts offered to other entities such as wholesalers, hospitals, physicians, pharmacies and third-party payors in other federal health care programs. The proposed effective date of this regulatory modification is January 1, 2020, although HHS has sought comments regarding whether this allows sufficient time for parties to restructure existing arrangements.

In addition, the Proposed Rule would add two new regulatory safe harbors for:

  • Certain price reductions that are fully passed through to the dispensing pharmacy and applied to the price charged to the member at the point-of-sale; and

  • Fixed fee payments from manufacturers to PBMs for the services that PBMs provide those manufacturers. In order to be protected, the fees would have to be for services that relate to the PBM’s arrangements with health plans (e.g., services that rely on data collected from health plan customers).

These new safe harbors would become effective 60 days after HHS publishes a final rule.

The potential implications of the Proposed Rule extend beyond the context of federal Anti-Kickback Statute compliance to drug reimbursement in the United States more broadly. The proposals will likely be subject to significant public debate and legal scrutiny.

The Proposed Rule is scheduled to be published in the Federal Register on February 6, 2019, and public comments on the proposals would be due 60 days later. The Proposed Rule can be found here and the HHS Factsheet is available here.

 

© 2019 McDermott Will & Emery

Telehealth Gets a Boost in Proposed Physician Fee Schedule

Some very good news for the telehealth community can be found amidst the more than 1,400 pages of the proposed Medicare Physician Fee Schedule for 2019 (“Proposed Rule”) issued by CMS yesterday.  Finally, CMS acknowledges just how far behind Medicare has lagged in recognizing and paying for physician services furnished via communications technology.

Virtual Check-In

The longstanding barriers to Medicare payment for telehealth visits based on the location of the patient and the technology utilized could soon give way to payment for brief check-in services using technology that will evaluate whether or not an office visit or other service is warranted.  CMS proposes to establish a new code to pay providers for a virtual check in. For many telehealth providers, the payment proposal will not go far enough since the new code can only be used for established patients. CMS notes that the telehealth practitioner should have some basic knowledge of the patients’ medical condition and needs that can only be gained by having an existing relationship with the patient.

Store and Forward

In other good news, the Proposed Rule creates a specific payment code for the remote professional evaluation of patient-transmitted information conducted via pre-recorded “store and forward” video or image technology.  CMS recognizes that the progression of technology and its impact on the practice of medicine in recent years will result in increased access to services for Medicare beneficiaries. CMS is seeking comment as to whether these type of telehealth services could be deployed for new patients as well as existing patients.

The Bipartisan Budget Act of 2018

The Proposed Rule also implements important expansions of telehealth services included in the Bipartisan Budget Act of 2018 (“BBA of 2018”) passed last winter. The BBA of 2018 made way for end-stage renal disease patients to receive certain clinical assessments via telehealth beginning in January 2019.  Under the Proposed Rule, CMS proposes to amend its regulations to add in the home of the patient as the “originating site.” Under existing Medicare rules, the patient’s home is not an appropriate “originating site” for a telehealth visit.

Comments on the Proposed Rule are due by September 10, 2018.

 

©1994-2018 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Department of Justice Announces Task Force to Combat Prescription Opioid Crisis

Last week, United States Attorney General Sessions announced the creation of the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force to combat the prescription opioid crisis.  According to the Department of Justice (Justice), the PIL Task Force will rely on “all available criminal and civil enforcement tools” to hold those at “at every level of the [opioid] distribution system” accountable for unlawful conduct.  This significant step may result in greater oversight and widespread criminal and civil prosecutions.

Prescription opioids, such as oxycodone, hydrocodone and morphine, are powerful pain-reducing drugs, but may also trigger feelings of pleasure or a “high.”  Prolonged use of opioids can lead to addiction, misuse and abuse.  According to the United States Department of Health and Human Services (HHS), an estimated 64,000 Americans died of drug overdoses in 2016, with the vast majority the result of opioids – nearly 116 people lost their lives to opioids each day.  HHS declared a public health emergency in 2017, and followed with a strategic plan to improve access to prevention, treatment and support services to address it.  The PIL Task Force will work in conjunction with HHS to provide additional federal resources to address the problem.

At the manufacturer level, the PIL Task Force will examine existing state and local government lawsuits against opioid manufacturers to determine what, if any, federal assistance can be provided.  One example is already underway: Justice will file a statement of interest in the pending multi-district federal litigation in Ohio, which focuses on the improper marketing and distribution of prescription medications by manufacturers and distributors.  Justice will argue the federal government has borne substantial costs arising from the opioid epidemic and is entitled to reimbursement.

The PIL Task Force will also rely on existing laws to hold distributors, pharmacies and prescribers accountable for unlawful actions.  This work was underway even before the Task Force’s inception.  In 2015, for example, a grand jury returned a multicount indictment against Little Rock, Arkansas physician Dr. Richard Johns for unnecessarily prescribing oxycodone to patients, including to some patients he had neither examined nor met.  Johns later pleaded guilty to a single count of conspiring to possess with the intent to distribute oxycodone through a plea deal and received a nine-year federal prison sentence.

Finally, Attorney General Sessions directed the PIL Task Force to establish a working group to (1) improve coordination and data sharing across the federal government to better identify violations of law and patterns of fraud related to the opioid epidemic; (2) evaluate possible changes to the regulatory regime governing opioid distribution; (3) recommend changes to laws.

The Attorney General was clear: “We will use criminal penalties.  We will use civil penalties.  We will use whatever tools we have to hold people accountable for breaking our laws.”

The PIL Task Force is another example of federal, state and local actions to address the opioid epidemic, which may significantly impact the health care industry.  Dinsmore & Shohl is monitoring the situation and stands ready to assist clients in navigating these developments.

National Institute on Drug Abuse, Opioid Overdose Crisis (Feb. 2018)

U.S. Department of Justice, Attorney General Sessions Delivers Remarks Announcing the prescription Interdiction and Litigation Task Force (Feb. 27, 2018).

U.S. Department of Justice, Justice Department to File Statement of Interest in Opioid Case (Feb. 27, 2018),

U.S. Department of Health & Human Services, HHS Acting Secretary Declares Public Health Emergency to Address National Opioid Crisis (Oct. 26, 2017).

 

© 2018 Dinsmore & Shohl LLP. All rights reserved.

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.