Compliance Program Training for Your Board of Directors: What You Need to Know

By: Anne Novick Branan

Members of the Board of Directors[1] for health care organizations have important responsibilities related to corporate compliance. Government regulators expect health care Boards to assume greater responsibility to provide oversight for the corporate compliance programs and to promote an ethical culture in their organizations.  Failures in compliance programs that lead to criminal activities or improper billing expose an organization to substantial monetary and criminal penalties and further could expose individual Board members to personal liability.  Health care companies that provide effective education to Board members about their obligations related to the companies’ compliance programs can greatly minimize these potential liabilities.

The federal government’s message to health care providers is quite clear — if an organization deals with federal health care programs, the government expects the organization’s Board to be well educated and involved in the compliance program.  The Office of Inspector General for the Department of Health and Human Services (“OIG”) also made clear in recent corporate integrity agreements (“CIAs”)[2]  and published guidance that the federal government expects organizations to educate the Board members’ about compliance program duties and oversight responsibilities.  A typical CIA provision requiring such training may state:

The training shall address the corporate governance responsibilities of the board members and the responsibilities of board members with respect to review and oversight of the compliance program. Specifically, training shall address the unique responsibilities of the health care board members, including the risks, oversight areas, and strategic approaches to conducting oversight of a health care entity.  This training may be conducted by an outside compliance expert hired by the board and shall include a discussion of the OIG’s guidance on board member responsibilities.

CIAs usually require organizations to provide at least two hours of compliance program training for Board members.

The “OIG’s guidance on board member responsibilities” referred to in the CIA provision above can be found in an OIG publication, “Practical Guidance for Health Care Governing Boards on Compliance Oversight” issued April 20, 2015 (“OIG Guidance”).[3]  The OIG Guidance emphasizes the need for Boards to be fully engaged in the oversight responsibilities and offers practical tips for Boards as they work to effectuate their oversight role of the organizations’ compliance with State and Federal laws.  The critical element of the Board’s responsibility to stay informed on compliance matters is the Board’s obligation to ask the right questions of management to determine the adequacy and effectiveness of the organization’s compliance program.  Without sufficient training on its compliance-related obligations, a Board will be ill equipped to a make the meaningful inquiries of management and effectively exercise its oversight of organizational compliance.

However, how should health care companies provide such training and what should be included in the education? The OIG has stated that compliance program design and operation is not a “one size fits all” issue and that companies should tailor their compliance efforts to the size, complexity and culture of their organizations.[4]  Likewise, for compliance training, the organization should design and execute the training according to the organization’s and its governing body’s needs.

One approach is to provide an initial formal orientation and educational program for all governing body members that covers the key areas for compliance program oversight.   This program can be a part of a Board retreat, executive sessions or provided in regular board meetings.  At least two hours of initial training is advisable, but ongoing follow-up training and education is needed if the Board’s oversight of the compliance function will be effective.  Health care companies may provide the training with internal resources, typically through the organization’s chief compliance officer (“CCO”) or hire a compliance consultant or expert to conduct or assist with the training.

Many health care companies decide to hire a compliance expert to perform the Board education and training and this approach has certain advantages.  First, the OIG favors the use of outside compliance experts in its CIAs and the OIG Guidance, stating

Board members are entitled to rely on the advice of experts in fulfilling their duties.  OIG sometimes requires entities under a CIA to retain an expert in compliance and governance issues to assist the board in fulfilling its responsibilities under the CIA.  Experts can assist Boards and management in a variety of ways, including the identification of risk areas, provision of insight into best practices in governance, or consultation on other substantive or investigative matters.[5]

Using an outside expert can lend additional credibility to the training, especially for discussion involving legal standards for Board decision-making and the complex web of state and federal laws that apply to health care companies.   Health care consultants save the organization and CCO time and money by planning, preparing and performing the training, as well as providing educational materials and answering specific questions from Board members.  Moreover, Board members may feel more comfortable addressing questions with someone outside their organization about their concerns about potential personal liability and their responsibility for compliance.

The content of the initial training and orientation to the Board’s compliance program obligations should include at a minimum the following:

  1. The Board’s fiduciary duties. The training should effectively educate directors as to their various fiduciary duties in connection with the compliance function.  At a minimum, directors should be advised as to the duties of care and good faith dealings, including a duty of reasonable inquiry.[6]
  2. The organization’s compliance program. The Board must be trained on the structure and operation of the company’s compliance program.  According to the OIG Guidance, the Board should ensure that the structure includes, as a key compliance program element, a corporate information and reporting system.[7] Such a system not only keeps Board members informed of the activities of the organization, but also enables an organization to evaluate and respond to issues of potentially illegal or otherwise inappropriate activity.[8]
  3. Laws and regulations relevant to the organization. Companies should develop a formal plan to ensure that their Boards stay abreast of the ever-changing regulatory landscape.  The plan may involve periodic updates from the CCO, or consultants or attendance at industry educational programs. Board education should address legal authorities that generally apply to health care industry, as well as those specific to the organization’s industry segment, such as home health or physician group practices. Board members need to know about the False Claims Act,[9] Stark Law[10] the Federal Anti-Kickback Statute,[11]  the Health Insurance Portability and Accountability Act of 1996 and regulations[12] and other privacy laws, and federal program exclusion screening requirements, as well as applicable state laws that affect compliance.
  4. The Board’s responsibility for promoting a compliant culture within the organization. Training should emphasize the role of the governing body in setting the tone for an organizational culture that fosters integrity and ethical conduct based on overreaching company values.  Board members should understand that they are expected to adhere to the code of conduct and serve as examples of compliant and ethical behavior.    The organization should educate the Board on its obligation to encourage a level of compliance accountability across the organization.

As proof of its effective Board training, organizations are well advised to develop and implement a formal plan for annual training, regular compliance program updates and ongoing education, as well as a system of documenting such training.  Board meeting notices, agendas and minutes are key places to document the training. Recordkeeping should include qualifications for compliance educators and training materials used and distributed in annual training and ongoing education efforts.

In today’s aggressive enforcement climate, the Board members at the helm of health care organizations must be well informed and trained to execute their compliance program oversight responsibilities.  Whether the company chooses to use internal resources for such training or engage a compliance expert, the investment will certainly pay off in a more effective compliance effort and mitigated potential for liability arising from non-compliant conduct.

[1] While we discuss the obligations of “Boards of Directors” of corporations in this article, the obligations apply to the members of governing bodies of any entity operating a health care provider.

[2]   A CIA is an agreement between the OIG and a health care provider that typically settles a fraud investigation and imposes obligations on the provider to develop and implement compliance measures to address the conduct under investigation. See Corporate Integrity Agreements between OIG and Ortho-McNeil-Janssen Pharmaceuticals, Inc. (2010); Synthes, Inc. (2010).

[3] OIG et al., Practical Guidance for Health Care Governing Boards on Compliance Oversight (2015).

[4] OIG, et al., supra note 3 at 3.

[5] OIG, et al., supra note 3 at 5.

[6] In re Caremark Intern, Inc. Derivative Litig., 698 A.2d 959 (De. Ch. 1996); Stone ex rel. AmSouth Bancorporation v. Ritter, 911 A.2d 362 (De. 2006); American Health Lawyers Association, The Health Care Director’s Compliance Duties: A Continued Focus of Attention and Enforcement, 5 (2011).

[7] Such a reporting system may include an anonymous hotline to allow individuals to report suspected non-compliance.

[8] OIG, et al., supra note 3 at 2.

[9] 31 U.S.C. §§ 3729-3733.

[10] 42 U.S.C. § 1395nn.

[11] 42 U.S.C. § 1320a-7b(b).

[12] 45 CFR Parts 160 and 164.

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Broad and Cassel Health Law Practice Achieves Band One Ranking in Chambers USA 2017

ORLANDO, Fla. (June 16, 2017) — For the seventh year in a row, the Health Law Practice Group at Florida-based law firm Broad and Cassel LLP has once again received top honors within Florida by prominent legal guide Chambers USA: A Guide to America’s Leading Business Lawyers. The firm’s practice group was one of just two receiving a Band One ranking in the state, the highest ranking awarded by Chambers USA.

All told, the firm’s nationally recognized group saw the ranking of six individual attorneys, more than any other firm in the state, in addition to the group’s collective Band One ranking. Ranked attorneys include Managing Partner Gabriel Imperato, Partner Mike Segal, Partner Michael Bittman, Partner Lester Perling, Partner Stephanie Russo, and Of Counsel Stephen Siegel. Imperato, one of the group’s leading attorneys, received national recognition in health care, ranking among the best in the country for his work in health care regulatory and litigation.

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Posted in Gabriel Imperato, Honors and Awards, Lester Perling, Mike Bittman, Mike Segal, Practice News, Stephanie Russo, Stephen Siegel | Tagged , , , , ,

Reporting Changes from House Bill 229

By: Heather Miller and Kelsey Greenfield

In May, Gov. Rick Scott signed into law House Bill 229, which changes the impaired practitioner program. The impaired practitioner program aims to assist healthcare practitioners whose ability to practice safely is impacted by the misuse or abuse of alcohol or drugs, or by a mental or physical condition. If a licensee knows that a colleague has an impairment impacting their practice, the licensee is obligated to report it. Under the new law, a licensee’s duty to report colleagues is still only triggered by having knowledge of that impairment, not just a suspicion. While the standard for reporting remains the same, the new law creates another channel for reporting. Instead of reporting directly to the Florida Department of Health (DOH) or the applicable regulatory board, a licensee can report an impaired colleague to the individual or entity (known as a ‘consultant’) who operates an approved impaired practitioner program pursuant to a contract with the DOH. If an individual, a consultant is a practitioner licensed under chapter 458, chapter 459, or part I of chapter 464. If an entity, the entity must employ either a medical director licensed under chapter 457 or chapter 459, or an executive director licensed under part I of chapter 464. Individual practice acts have also been amended to include language concerning the new consultant reporting channel.

 

Posted in Heather Miller, Malpractice | Tagged , , , , ,

Florida Supreme Court Rules Cap on Pain and Suffering Damages Unconstitutional

By: Stephanie Russo

Noneconomic damages for pain and suffering no longer are capped in medical malpractice cases after the Florida Supreme Court’s recent ruling in North Broward Hospital District, etc., et al., v. Kalitan that the caps violate the Equal Protection Clause of the Florida Constitution.

In Kalitan, a jury awarded over $4.7 million in total damages to a patient who suffered catastrophic injuries resulting from surgical complications.  $4 million of the award was for past and future pain and suffering.  Applying the caps under Florida Statutes, Section 766.118(2), the trial court reduced the judgment by nearly $2 million.
However, in the North Broward Hospital District case, the Florida Supreme Court declared the caps unconstitutional because they “arbitrarily reduce damage awards for plaintiffs who suffer the most drastic injuries” and because “there is no evidence of a continuing medical malpractice insurance crisis justifying the arbitrary and invidious discrimination between medical malpractice victims, there is no rational relationship between the personal injury noneconomic damage caps…and alleviating this purported crisis.”
The Court was divided with only four members joining in the majority opinion. In a scathing dissenting opinion, three justices argued the majority failed to properly apply the rational basis test and usurped the role of Florida’s Legislature.
The dissent argued the rational basis test places the burden on the party challenging the statute “to show that there is no conceivable factual predicate which would rationally support the classification under attack” and “a legislative choice is not subject to courtroom fact-finding” but instead “may be based on rational speculation unsupported by evidence or empirical data.”
Explaining that under the rational basis test, it “is immaterial that the majority of this Court disagrees with the Legislature’s evidence regarding whether there was (or currently is) a medical malpractice crisis in Florida,” the dissent concluded the caps do not violate the Equal Protection Clause because:
[T]he Florida Legislature could have rationally believed that the cap on noneconomic damages … would reduce malpractice damage awards, which would thereby increase predictability in the medical malpractice insurance market and lead to reduced insurance premiums. Then, as a result of decreased insurance premiums, physicians would be more willing to stay in Florida and perform high-risk procedures at a lower cost to Floridians.
The dissent accused the majority of “just discard[ing] and ignor[ing] all of the Legislature’s work and fact-finding”  and “improperly interject[ing] the judiciary into a legislative function” in order to “essentially change a statute and policy it dislikes.”
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38 Broad and Cassel Attorneys Named Florida Super Lawyers, Nine Honored as Rising Stars

ORLANDO, Fla. (June 19, 2017) — Statewide law firm Broad and Cassel LLP today announced 38 of the firm’s attorneys have been named to the 2017 Florida Super Lawyers list. Additionally, nine attorneys were honored as 2017 Rising Stars by Florida Super Lawyers Magazine, which publishes its annual list in July.

Super Lawyers selects attorneys using a rigorous, multiphase selection process. Peer nominations and evaluations are combined with third-party research, and each candidate is evaluated on peer recognition and professional achievement. Just five percent of attorneys are selected to Super Lawyers.

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Keeping Internet Pirates At Bay: Ransomware Negotiation In The Healthcare Industry

Fort Lauderdale Attorney Paul R. DeMuro published the following article in the June 2017 edition of the Nova Law Review. 

pdemuroThe law plays a significant role in all negotiations, regardless of the context. The law can determine the who, what, when, where, and why of all negotiations. Given the importance and power of law in the negotiation context, adopting clear legal principles tailored to negotiations in specific contexts will help willing and unwilling negotiators reach their desired outcomes. Negotiation comes into play in a number of different areas, both legal and otherwise.

One venue where the negotiation principles used in legal and nonlegal areas coincide is the venue of ransom negotiations. Like other negotiations, ransom negotiations feature adverse parties with competing interests struggling to promote their own ends. With ransom negotiations, however, the stakes are often much higher than a standard negotiation and the party demanding the ransom payment has the opposing party at a distinct disadvantage.

To download and read the full article, please visit this link. 

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24 Broad and Cassel Attorneys Named to Chambers USA 2017

ORLANDO, Fla. (May 26, 2017) — Florida-based law firm Broad and Cassel LLP has once again received recognition by prominent legal guide Chambers USA: A Guide to America’s Leading Business Lawyers. In total, the 2017 edition highlights 24 Broad and Cassel attorneys as leaders in their respective fields, while the firm is listed as among the best in seven statewide practice areas.

The firm’s nationally recognized Health Law Practice Group once again received top honors within Florida – ranking six individual attorneys in addition to the group’s collective Band One ranking, the highest ranking awarded by Chambers USA. One of the group’s leading attorneys, Fort Lauderdale Managing Partner Gabriel Imperato, received national recognition in health care, ranking among the best in the country.

Additionally, the firm received recognition for its work in the following practice areas: Banking & Finance, Construction, Healthcare, Litigation: General Commercial, Litigation: White-Collar Crime & Government Investigations, Real Estate and Real Estate: Zoning/Land Use.

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Posted in Gabriel Imperato, Honors and Awards, Lester Perling, Mike Bittman, Mike Segal, Stephanie Russo, Stephen Siegel | Tagged , , , , , , ,

Amendment 7 Not Preempted By Federal Law

By: Timothy Wombles

In a recent case, Charles v. Southern Baptist Hospital of Florida, Inc., the Florida Supreme Court held that hospital and physician incident reports required by Florida law are not protected from discovery by the Federal Patient Safety and Quality Improvement Act (“PSQIA”) and Amendment 7 is not preempted by federal law.

Proposed by citizen initiative and adopted by constitutional amendment in 2004, Amendment 7, which continues to be called by its ballot designation, permits individuals to request adverse medical incident records from health care facilities or providers. Hospitals and physicians are required to create and maintain adverse medical incidents records by the Florida Statutes.

Congress passed the PSQIA in 2005 to “facilitate an environment in which health care providers are able to discuss errors openly and learn from them” in response to an Institute of Medicine report detailing the prevalence of medical errors and preventable deaths in the United States. The PSQIA specifies that reports regarding patient injuries, known as patient safety work product (“PSWP”), may be collected in a patient safety evaluation system to share with a patient safety organization. PSWP is confidential and protected from disclosure by the PSQIA. Alternatively, data collected or developed separately from a patient safety evaluation system is not PSWP.

In the case at hand, Jean Charles, Jr. filed a medical malpractice lawsuit on behalf of his sister against Southern Baptist Hospital of Florida (‘Southern Baptist”). Pursuant to Amendment 7, Charles sought adverse medical incident records from Southern Baptist. The Duval County Circuit Court found that incident reports and other records Charles requested were not PSWP since they were collected “for a purpose other than submission to a patient safety organization or for dual purposes” and granted orders compelling production of the records to Charles. Southern Baptist challenged the ruling by filing a writ of certiorari with the First District Court of Appeal. Granting the petition and quashing the circuit court’s orders, the First District Court of Appeal held that since Amendment 7 required the hospital to provide records protected from disclosure by the PSQIA, federal law preempted the Amendment 7 request.

The Florida Supreme Court reversed the appellate decision, agreeing with the circuit court compelling the hospital to produce the adverse medical incident records under Amendment 7. Southern Baptist created the adverse medical incident records to comply with Florida law, so the Court found that the records were created for a dual purpose. Since the adverse medical incident records were not created solely for submission to a patient safety organization, the records were excluded from PSWP. As records excluded from PSWP are not protected from disclosure by the PSQIA, the Supreme Court held that federal law did not preempt Amendment 7.

Florida hospitals and physicians should to be cognizant that records collected solely for reporting to a patient safety organization are protected from disclosure by the PSQIA. Records collected simultaneously for submission to a patient safety organization and any other purpose, even to comply with Florida law, fall outside of the discovery protections of the PSQIA.

 

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Adjusting Group Practice Compensation in a World Turning Value-Based (Part I of II)

By: Mike Segal

    Payors are beginning to take steps to transform from reimbursement based on medical services rendered, or “fee for service” medicine, to payment for attaining quality measures without regard to volume, which is often called “value based” care.  The trend is expected to continue to accelerate, significantly as a result of The Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”), which began to apply this year, and will begin to affect Medicare reimbursement in 2019.  Virtually every physician is subject to MACRA, and his or her income can be affected based upon his or her scores, or those of his or her medical group, in the MACRA value based valuations.   MACRA offers two alternatives.  A physician can be judged under the MIPS scoring system, or as an APM.  While APM status offers more potential economic reward (and MACRA is heavily weighted toward cojoling physicians to move into APM status) it also bears more risk, and many physicians and medical groups will remain in MIPS status for a time.  Either way, significant reporting of quality standards is required, everyone will be rated (MACRA is a competitive program), and results will be obtainable by patients on the internet.

  In addition, both Medicare and commercial payors are, through MACRA and other means, pushing physician groups to accept more risk, and to be responsible to have their reimbursement reduced if costs rise too much, or quality of performance falls below a certain standard.

   In my experience of more than a quarter century in helping to create and maintain medical group practices, physician groups are typically divided into multiple “care centers,” with each care center retaining income based on a revenue collected, predominantly fee for service, “eat what you kill” (or, as we often call it, “eat what you heal”) compensation system.  If there is more than one physician working in the care center, the care center physicians are free to determine their compensation in any manner they choose so long as the system complies with all laws and the central Board approves, but any such compensation structure is almost always fee for service based.  While the groups do often attempt to monitor quality of service, and to hold themselves out as quality providers, they have not previously been required to meet all the requirements of MACRA.

    Clearly the compensation formulae developed over so many years for group practices are going to need to be re-addressed.  I have read many articles on this subject.  It seems that many groups throughout the country are in the process of adjusting their compensation formulae to provide for a portion (usually between 15-25%) of compensation to be determined based on “value based” criteria.  I think that, as MACRA becomes better understood and, although perhaps grudgingly, accepted, the pressure to revise the manner of determining compensation will increase.

 There are, however, two formidable barriers to making this happen.  First, group leadership must be convinced that a change is necessary, and then agree on an appropriate revision.  Second, the group must get the necessary vote of its partners/members.  For most groups, a vote of at least 2/3 of the partners/members is necessary to revise the standard compensation formula.  As a result, amending a compensation formula where many physicians will at least perceive that they will not fare as well is a formidable challenge.

  In our next newsletter I will publish Part II of this article.  There I will provide specific ideas for adding value based concepts to compensation, and will discuss what has been done by others to  be able to convince the group’s physicians to make the necessary revisions.

 

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Compliance Leaders Offer Sound Advice at Orlando Health Care Forum

ORLANDO, Fla. (May 4, 2017) – The risks to Florida health care providers from enforcement activity is at an all-time high. But, how do providers develop and maintain a culture of compliance? It starts at the top, according to attorneys at Broad and Cassel.

During the firm’s Third Annual Orlando Health Care Forum, attorneys from the Health Law Practice Group alongside local and national leaders in healthcare compliance discussed board responsibility as well as board and executive leadership strategies and pitfalls.

“Our organizations are under threat from the government, whistleblowers and payers,” said Partner Michael Bittman, co-chair of the Health Law Practice Group, in his opening remarks. “There is a huge effort under foot to hold organizations and their executives accountable. The government is taking the position that the way to change corporate culture is through individuals.”

The forum kicked off with a fireside chat between Managing Partner Gabriel Imperato and Cigna Corporation’s Chief Compliance Officer Thomas F. O’Neil III discussing the board’s responsibility in compliance oversight.

“At the end of the day, if leaders aren’t assessing risks, you’re really vulnerable,” said O’Neil. He further noted the importance of transparency by management, embracing integrity and ensuring the board has the tools and information it needs to be effective.

During a panel discussion on board strategies and pitfalls, Withum Senior Policy Advisor Al Gutierrez commented that compliance officers are the corporate citizens for the organization and need to hold that attitude personally. He also suggested compliance officers engage more in scenario-based planning to prepare for an event.

“The whistleblower risk is so acute in the health care industry, you ignore any report of noncompliance at significant risk,” said Imperato. “Even an innocuous report can become a nightmare for an organization.”

The Health Forum concluded with a panel on health plan overpayments. Panelists included Michael Bittman, Michelle J. d’Arcambal of d’Arcambal Ousley & Cuyler Burke, and Jeanmarie Loria of Advize Health. Panelists reviewed pre-litigation considerations as well as litigation strategies and pitfalls tied to overpayments. “Don’t wait for an audit. Audit yourself,” said Loria.

Bittman went on to say, “Compliance must start at the top and permeate the organization. The delivery of a problem early is good news. The delivery of a problem late is very bad news.”

Broad and Cassel will host its seventh annual South Florida Health Forum in Fort Lauderdale this fall. The statewide law firm has built one of the most experienced and diversified Health Law Groups in the Southeastern United States. The firm has more lawyers certified in Health Law by the Florida Bar Board of Legal Specialization & Education than any other firm. Several of the firm’s health lawyers are certified by the Health Care Compliance Association in Health Care Compliance and are Certified Dispute Resolvers with the American Health Lawyers Association. Broad and Cassel’s health lawyers are widely published and frequently make presentations at leading educational programs throughout the country. Information on the firm’s health law events and industry and attorney news can be found on Broad and Cassel’s Health Law Blog at www.healthlawfla.com or on Twitter at www.twitter.com/healthlawfla.

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