Does Ability to Pay Count for Anything Any More?

By: Benton Curtis

Through the Health Care Fraud and Abuse Control Program Report (the “HCFAC”), the Department of Health and Human Services and the Department of Justice (“DOJ”) annually trot out their most recent efforts to combat health care fraud – be it criminally, civilly, or administratively – around the country.  The HCFAC often times showcases the most prominent of matters, either in terms of conduct or monetary recovery, and the statistics embedded within the HCFAC are undoubtedly used as a justification to request of Congress continued (or preferably increased) funding in the space.  Sadly what is lost, though, amongst these splashy figures are certain policies that, while well-intentioned, cut against the federal government’s ability to efficiently and thoughtfully obtain a return on their investment.

 To the above point, on September 9, 2015, DOJ issued a new policy memorandum, signed by Deputy Attorney General Sally Quinlan Yates, that addressed the need for more individual accountability in instances of corporate misconduct (the “Yates Memo”).  The Yates Memo specifically established a series of new guidelines intended to further this overarching new policy and one of those guidelines promulgated that “[c]ivil attorneys should consistently focus on individuals as well as the company and evaluate whether to bring suit against an individual based on considerations beyond that individual’s ability to pay.”  In setting forth this point, DAG Yates noted that while the twin aims of civil enforcement efforts – recovering as much money as possible and accountability for and deterrence of individual misconduct – can be in tension with one another at times, they are nonetheless equally important and “the fact that an individual may not have sufficient resources to satisfy a significant judgement should not control the decision on whether to bring suit.”

 While in theory this aggressive new civil position could generate the desired perception that a lack of seizable assets will not render an individual judgment-proof, its practical application will likely result in immeasurable, wasted government resources.  Indeed, your typical civil False Claims Act investigation, whether standing alone or as part of a parallel matter, is neither streamlined nor brief; quite the opposite as most civil investigations, regardless of scope and complexity, languish for years as government agents and attorneys plod through potential evidence to determine if their prosecutorial theory has any merit.  As any investigation proceeds, though, agents and attorneys should begin to gain a firmer grasp of core issues, such as the size of the alleged fraud, an individual’s involvement with or contribution to that alleged fraud, and an individual’s ability to monetarily atone for their actions.  In other words, the government should always be able to discern within a reasonable amount of time whether someone has sincere civil exposure and whether they have the financial resources necessary to cover that exposure.

 Under the Yates Memo, civil attorneys are rigidly forced at times to lurch forward and pursue individuals, even when they know – sometimes well in advance – that those individuals are insolvent, near insolvent, or incapable of fully satisfying a future judgment.  Moreover, those same civil attorneys lurch forward knowing that to the extent individuals still have resources to satisfy all or part of a judgment, those remaining resources will be depleted by the legal fees associated with defending against unnecessarily prolonged government investigations.

As I write the above, I recognize there is no silver bullet approach.  But, given the glaring need for fiscal responsibility by our federal government, DOJ needs to quantify the value of deterrence (assuming it even can be calculated) and determine if that value exceeds, or at least equals, the opportunity cost associated with investigating and prosecuting judgment-proof individuals.  If it does not, DOJ should soften this approach and afford its prosecutors more discretion to pursue individuals who can actually satisfy a significant judgment.

Posted in Benton Curtis, Compliance, Fraud/Abuse | Tagged , , , , , , , , , ,

In Life and Business- The Importance of the 5 Ps

By Stephen H. Siegel

Included in the training of new Assistant United States Attorneys is a saying: “proper preparation prevents poor performance” (the “5 Ps”). This saying is applicable to both our personal and professional lives.

For example, many of us prepared for our first “major” hurricane in over a decade. Those who lived within the projected path of Hurricane Matthew faced the choice of doing nothing or taking minimal precautions and hoping for the best, or taking more aggressive measures such as putting up shutters if they did not have storm windows. In large part, the level of our effort and concern was a function of how well we had prepared in advance.

Similarly, healthcare providers need to recognize the importance of planning and preparation for business risks.  Some risk areas are rarely ignored, perhaps because they are integral to the practice of medicine. Other potential risks may be overlooked because they are outside of medical training programs, or seem too remote, expensive, or complicated to address. These risks include changes in the manner in which professional medical services are reimbursed, complying with regulatory requirements, and cybersecurity.

As with hurricanes, evaluating a risk depends on its likelihood of occurring. It is only after the risk has passed, that it becomes possible to evaluate the actual harm. As we approach the end of this year and begin preparing for the next, some of the risks that all healthcare providers need to be anticipated include cybersecurity, malware, ransomware and OCR audits, and the “60-Day Rule”. In addition, for physicians – MACRA and how it will impact their reimbursement. (Hint: If you are not familiar with any of these risks, you probably need to get up to speed quickly!)

A basic step in dealing with any of these, or any other, potential risk is assembling a team of professionals (attorneys, accountants, software consultants, billing experts, etc.). Ideally, this team will be assembled before it becomes necessary to call on their expertise. Thus, like hurricane shutters, it will not be necessary to scramble in order to identify and retain team members while simultaneously dealing with a crisis. The saying “proper preparation prevents poor performance” should serve as an important guideline in both business and life.

Posted in Care Delivery, Risk/Liability, Stephen Siegel | Tagged , , , , , , , , , ,

Whistleblowers in Health Care- What’s a Company To Do?

By: Anne Novick Branan

             Joe, the Practice Manager at a local medical group, cringed as he spied Susan, one of the nurses at the practice, marching toward him with an anxious, yet determined, look on her face.  About two months ago, Susan confided in Joe that she heard that certain physicians in the medical group were accepting expensive sports event tickets from diagnostic centers to which the physicians frequently referred patients.  She told him that it was wrong and maybe even illegal for the physicians to accept such gifts.  To appease Susan, Joe had told her that he “would look into it,” but never quite got around to doing anything about it.  Joe resented Susan for creating this problem for him and started screaming at her over every little thing she did wrong at work.   Susan approached Joe today to ask what happened about the issue she raised and to complain that he was harassing her since she reported this problem to him.  When Joe had no good answers for Susan and Joe’s mistreatment of her continued, Susan started make phone calls to lawyers about how she could blow the whistle on the medical group.

            Unfortunately, scenarios like the one described above are not uncommon in the health care arena.  The threat for health care providers from qui tam actions, also known as whistleblower lawsuits, under the federal False Claims Act (“FCA”) and similar state false claims statute, is very real these days.  Recent statutory changes in the FCA strengthening protection of whistleblowers, combined with the government’s intensified interest in stopping health care fraud, increase the likelihood of success for the whistleblower in such suits.  Plus, tough economic times and the lure of potentially sizable financial rewards have increased employees’ willingness to embark on the difficult journey involved in bringing a qui tam case.  Indeed, whistleblowers continue to play an important role in helping the United States government fight fraud and recover funds.

            Under the FCA qui tam provision, persons with evidence of the submission of false claims to a federal program, like the Medicare program, can sue the wrongdoer on behalf of the United States.  The government has the right to intervene in such actions, but if the government declines, the private plaintiff may proceed on his or her own.  Employees who bring qui tam actions can receive between 15 and 30% of any monies recovered by the government.  The FCA specifically protects employees who become whistleblowers from retaliation by their employers.

            Employers are best advised to take steps to prevent its employees from becoming qui tam relaters.  One factor in an employer’s favor is that employees leave a lot behind when they decide to become whistleblowers.  Pursuing such complex litigation can be a lengthy, expensive and emotionally-draining process and can damage the employee’s ability to find work in the health care field.  For employers, there is a tremendous cost in defending such litigation, paying substantial financial penalties and risking damage to their reputations.  There is much health care companies can do to discourage well-meaning employees who raise compliance concerns from escalating the concern to a qui tam or retaliation action against the employer.  Such proactive measures by employers should  include:

  • Establish A Strong, Effective Compliance Program. An employer’s most powerful defense against whistleblowers is to implement an effective corporate compliance program that promotes a culture of ethical conduct and compliance. While a culture of compliance may seem like a cliché, it is clearly missing in many workplaces.  A well-designed and implemented compliance program provides the framework for an organization to respond to compliance issues. To avoid qui tam litigation, employers  develop  policies and implement processes to (1) provide anonymous procedures for reporting compliance concerns; (2) promptly and impartially investigate legitimate employee compliance complaints; (3) respond appropriately to confirmed compliance violations; and (4) protect individuals who report concerns from retaliation.  To be effective, such policies must have the commitment of top management and must be adequately communicated to employees. Employees who do not believe management is committed to compliance, and those who fear retaliation for bringing issues to light, are less likely to help a company solve its problems and more likely to take their complaints to Uncle Sam.
  • Treat Reporting Employees Carefully. When an employee comes to the employer with a compliance concern, it is in the employer’s best interests to de-escalate the situation from the outset and to forge the most positive relationship with the individual as possible.  However, supervisors who are threatened by employee compliance reports may treat the employee with hostility, suspicion or retaliation.  Reporting employees should be assured that the company will take the complaint seriously and act appropriately to address any compliance deficiency. It is important to report back to reporting employees periodically so they know the company is addressing their concerns.
  • Develop Training Programs for Managers and Supervisors about Dealing with Potential Whistleblowers. Managers and supervisors are the first line of defense in preventing retaliation against reporting employees.  Respondents to the Ethics Resource Center’s 2013 National Business Ethics Survey indicated that employees initially report issues to their managers or supervisors over 60% of the time and that 21% reported being retaliated against for reporting such misconduct.   Even the most robust compliance policies for dealing with employee compliance complaints will not stand up unless supervisors and managers are trained on the fine points of how to recognize a potential whistleblower and respond to such complaints with sensitivity.  All too often, managers and supervisors get this wrong and companies want to make sure they get it right.   Those with supervisory responsibilities need to know how to receive and handle reports without retaliating, and how to spot and halt retaliation they may observe, even more subtle forms of retaliation such as “disinviting” the employee to routine meetings or giving negative performance reviews.  The human resources department should also be trained on how to handle employment issues related to potential whistleblowers, conduct exit interviews and identify people in the annual review process who are not happy with the company’s ethical climate.

A proactive approach to potential whistleblowers can save health care employers the substantial aggravation and expense that result from defending qui tam or retaliation litigation.  Employers will certainly reap positive benefits from investing resources in their compliance programs to effectively address responding to reports of compliance concerns and the protection of reporting employees.


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Physicians – Dissatisfaction, Change, and Dealing With Both

By: Stephen H. Siegel

November, when physicians, other healthcare professionals, and their businesses frequently begin planning for the upcoming year. It is also time to look inward/backward and consider those goals not achieved, surprises (pleasant and unpleasant), disappointments, and unanticipated issues that has have arisen during the year. All of this reflection will go for naught without identifying what improvements and corrections need to be made, likely upcoming challenges, and obtain the assistance of knowledgeable professionals (accountants, attorneys, certified coders, etc.) to address them. Otherwise, it is almost impossible to set and achieve new goals and address new challenges.

For many physicians addressing the issues of professional dissatisfaction and the changes that appear to be inevitable are critical to this process.

Please continue reading at South Florida Hospital News.

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A Roadmap to Licensure Investigations

By: Vanessa Reynolds

For healthcare practitioners, few events are as anxiety-provoking as a professional licensure complaint and investigation. Even if a complaint is ultimately determined to be unfounded, responding is time-consuming and can be disruptive to a practice.

The Florida Department of Health (Department) is responsible for investigating complaints. Patient complaints, reports of adverse medical incidents or peer review actions and other mandatory reports may trigger an investigation, as may reports submitted by other state agencies, malpractice payments in excess of $50,000, and any “reasonable cause to believe” that a practitioner has violated any law or obligation governing the practitioner’s profession.

Physicians are afforded 45 days in which to respond to a notice of investigation, while other practitioners are given 20 days. The notice informs the practitioner of the substance of the complaint and that he or she may agree to be interviewed or to submit a written response. Although not noted in the Department’s letter, the practitioner may also opt to do neither, and to wait until the Department’s investigation is complete.

Please continue reading this article at South Florida Hospital News.



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Pharmacists Need a Role in Medical Marijuana

By: Paul DeMuro, Ph.D., J.D., M.B.A., CPA and Jose Valdes

Pharmacists may well be the best equipped to assist in closing the knowledge gap doctors face as states approve medical marijuana laws.

Who might better determine how marijuana interacts with the nervous system and other medications, as well as its side effects, than those in the pharmacy profession who spend years in academic and practical programs, studying medications, their interactions, and side effects?

Some states are catching on to this idea, requiring that a board certified pharmacist be involved in the dispensing of medical marijuana. Soon pharmacists’ asking their patients if they use marijuana may become an important question as it becomes more widely researched and used.

How will the federal government and its agencies fund and/or facilitate the funding of such research if the Drug Enforcement Agency still classifies marijuana as a Schedule 1 drug? Currently, the University of Mississippi is the only university authorized to grow the drug for use in medical studies so this has limited the supply of marijuana for federally approved research purposes.

Please continue reading this article at The SunSentinel.

Posted in Care Delivery, Paul DeMuro, Regulatory | Tagged , , , , , , , ,

Your Zip Code is the Best Predictor of Your Health

By: Paul DeMuro, Ph.D., J.D., M.B.A., CPA and José Szapocznik, Ph.D.

In today’s America, people live in two distinctly different worlds. Dr. Garth Graham, President of the Aetna Foundation, points out that “life expectancy in New Orleans can vary as much as 25 years between neighborhoods just a few miles apart.” If a physician sees two patients, one from a well to do neighborhood in New Orleans and the other from one of the poorer neighborhoods, both of whom present with Type II diabetes due to overweight and a sedentary lifestyle, and that physician prescribed the exact medications and the exact lifestyle changes, will these two patients have the same outcome?

One of them, if she chose to, will be able to get a trainer to come to her home, and buy plenty of the best fresh produce, but the other will not. One will be able to arrange her schedule to arrive at work an hour later or leave an hour earlier to make it to her exercise class, whereas the other, an hourly employee, will not. And when the patient living in the poor neighborhood gets home, she won’t be able to go for a walk in her neighborhood because it might be too dangerous. There was a time when neighbors used to walk the sidewalks in poor neighborhoods, but now as crime has increased, residents are afraid to be outdoors. Actually, when Dr. Szapocznik asked mothers from an inner city neighborhood about their children’s play, they told him that after five in the afternoon, the mothers make sure that all the family is indoors because it is too dangerous to be outside.

Please continue reading this article at The Lund Report.

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The Evolving Role of Pharmacists in the Transformation to Payment for Quality and Cost-Effectiveness and the Attendant Legal Hurdles

By: Paul DeMuro, Ph.D., J.D., M.B.A., CPA, and Yesenia Prados, Pharm.D

The traditional role of pharmacists

When one thinks of pharmacists, one typically thinks of the individual in the retail pharmacy who fills his or her prescription that was “written” by a clinician. This traditional role of pharmacists was managing the production and dispensing of drugs. Pharmacists have only been considered dispensers, and not providers and thus their practice has been limited. Patients often viewed their pharmacists as businessmen and not as healthcare professionals. They thought their only role was to make a sale and patients were only there to make a purchase. Since patients often walked into a retail pharmacy where many things were being sold in addition to pharmaceuticals, this perception was probably not incorrect.

What pharmacists are doing today?

Today, the role of pharmacists is evolving such that pharmacists are much more involved in the management of patient care. Patients often see pharmacists as their go to health professional who is easily accessible. As pharmacists are now able to identify and meet a patient’s drug-related needs, they are attempting to lead the way and provide better patient care with their significant clinical knowledge, which has not been used to its full potential in the past. Pharmacists are now able to play an integral role in the healthcare system. The concept of clinical pharmacy has taken hold as the profession continues to move towards being patient-focused. In 2010, the Affordable Care Act identified pharmacists as medication therapy management (MTM) providers, allowing them to become formal members of the new integrated health care delivery models.

Please continue reading this article at AIMM’s website.

Posted in Care Delivery, Clinical Integration, Paul DeMuro | Tagged , , , , , , , , , , , ,

Beware of Excluded Individuals and Entities

By: Anne Novick Branan

One of the recent enforcement trends landing practitioners in hot water is the federal government’s pursuit of those who employ Medicare or Medicaid excluded individuals or entities. Federal statutes allow the Office of Inspector General for the Department of Health and Human Services (OIG) to exclude individuals and entities from participating in federal healthcare programs if they have been convicted of fraud or engaged in other misconduct. State Medicaid programs are required to exclude from participation any person or entity that has been excluded by the OIG. As of April 2016, more than 60,000 individuals and 3,000 entities were excluded from participation in federal healthcare programs.

Federal healthcare programs are prohibited from paying for items or services that have been furnished by someone who has been excluded from participation in these programs. Providers must ensure that they do not bill for services furnished by excluded persons. An excluded individual or entity engaged by a provider directly or even indirectly, such as through a staffing agency can raise concern. Companies, like home health agencies and labs, that bill federal programs for services prescribed or ordered by an excluded physician are also at risk. Excluded individuals may include nurses, physicians, or x-ray technicians, among others. Excluded individuals in administrative roles, like coders or marketers, who do not directly furnish healthcare services can also cause trouble for providers.

Please visit this page to continue reading.
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CMS Announces New Flexibility with MACRA

By: Mike Segal

It is now quite clear that the Medicare Access and CHIP Reauthorization Act, or MACRA, enacted into law in 2015, will have a telling effect on how Medicare reimburses for physician services.

In April 2016, the Centers for Medicare & Medicaid Services (CMS) released a voluminous proposed rule for implementing MACRA.  The full implementation of MACRA, with monetary bonuses and penalties, will not occur until 2019.  However, the proposed rule made clear that 2019 results for MACRA’s MIPS model (where it is estimated that more than 90% of all physicians will be placed at the inception of MACRA) would be based on physician performance in 2017.  Thus, every Medicare provider physician in the country was expected to get ready for 2017 in very short order.

CMS gave stakeholders until the end of June to comment on the proposed rule. The final rule was, and is still, expected to be released by November.

Heavy among the comments was that physicians would have great difficulty being ready by 2017.  Many asked that the implementation of MACRA be delayed.

Responding to these comments, on September 8, in the CMS Blog (talk about 21st Century – to be update you must keep your eye on the CMS blog!), Andy Slavitt, Acting Administrator of CMS, announced some new flexibility in the pace of MACRA reporting for 2017.   The blog now provides four options, two of which are new:

  1. Option One – So long as the provider submits some data to the CMS Quality Payment Program (QEP), including data from after 2016, there will be no payment penalty imposed for 2019 (NOTE: no definition of the word “some” was provided – presumably that will come later).
  2. Option Two – If the provider only elects to participate for 2017, and report information to the QEP, for a certain amount of days, it may qualify for a small bonus.
  3. Option Three – The provider may report in full for 2017, as originally anticipated.
  4. Option Four – The provider may participate in MACRA’s APM model, for practices willing to accept some considerable risk, for 2017.

It is important to note that CMS is only providing the new options for 2017. It still expects all providers to be able to fully report by 2018.

In addition, given the fact that the MPIS model is to be budget neutral, taking potentially negative practices off the grid almost certainly means that the MPIS or APM bonuses, or both, will be reduced for 2019.

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