Compliance Today

  1. Meet Jordan Muhlestein: Keeping a hand on compliance's pulse

    Compliance Today - October 2020  | October 2020 

    AT: Your first experience working in healthcare wasn’t in compliance or even a related field, like law or internal audit, but as an electrocardiogram (EKG) technician. Do you remember what your experience with compliance was back then, if any?...

  2. Tips for optimizing life sciences board oversight over clinical trials

    Compliance Today - October 2020  | Author: John Barker  | October 2020 

    Life sciences companies wanting to market new drugs, biological products, and medical devices across state lines must conduct clinical trials to obtain approval from the U.S. Food and Drug Administration (FDA) to do so.[1] These companies’ compliance professionals and board members face unique and evolving compliance challenges. This article provides practical tips for board members and compliance professionals for optimizing clinical trial oversight. It first reviews the fundamental duty established in the Delaware case of In re Caremark to monitor a corporation’s legal and regulatory compliance and business performance.[2] Second, it discusses the lack of guidance for life science companies...

  3. Conventional care: A compliance challenge for research services

    Compliance Today - October 2020  | Author: Lynn Asher  | October 2020 

    The terms “standard of care” and “conventional care” are commonly used interchangeably in research but have distinct meanings. The confusion often comes from the overlapping definitions of the two terms. A service that is standard of care may not meet the higher threshold for conventional care. Standard of care can be the practice of an individual physician, a recognized treatment for a medical condition, or a comment on research contracts that an item is not included in the total payment because the sponsor has determined it is part of standard medical practice...

  4. Solid as a ROC: Strengthening your research operations core

    Compliance Today - October 2020  | Authors: Sarah M. Couture, Brian D. Annulis  | October 2020 

    Since the inception of ClinicalTrials.gov, “a database of privately and publicly funded clinical studies conducted around the world,” in 2000,[1] the volume of registered clinical trials in the United States has skyrocketed. As of August 9, 2020, there were 115,883 active clinical trials in the United States.[2] Commensurate with the growth in registered clinical trials, there has been increased oversight and regulatory focus on clinical trials, including Common Rule updates,[3] billing compliance enforcement, scientific misconduct investigations, conflict of interest inquiries, and kickbacks and related enforcement actions, to name a few. As institutions pursue clinical research opportunities, whether industry sponsored or...

  5. OCR's COVID-19 regulatory relief: Changing how we deliver care

    Compliance Today - October 2020  | Authors: Jessica Quinn, Vladimir Edmondson  | October 2020 

    Almost 25 years ago, Congress passed the Health Insurance Portability and Accountability Act of 1996 (HIPAA), establishing a national framework for patient privacy.[1] To ensure an appropriate balance between individual privacy rights and public health needs, Congress included the following statutory language: “Nothing in this part shall be construed to invalidate or limit the authority, power, or procedures established under any law providing for the reporting of disease or injury, child abuse, birth, or death, public health surveillance, or public health investigation or intervention.”[2] Consistent with this congressional intent, when drafting the Standards for Privacy of Individually Identifiable Health Information...

  6. Are we there yet? Delivering on the promise of digitizing healthcare information

    Compliance Today - October 2020  | Author: Jon Moore  | October 2020 

    Several decades ago, the US healthcare industry started a journey in search of improved care and reduced costs by digitizing health information. Since then, there have been course corrections introduced through new legislation[1] and regulation,[2] as well as fuel fill-ups in the form of tens of billions of dollars in incentives for the meaningful use of certified healthcare technology.[3] Nevertheless, today it is not clear if the industry is any closer to arriving at its hoped-for destination. Or is it?...

  7. Three lines model gets it—almost

    Compliance Today - October 2020  | Author: Gerry Zack  | October 2020 

    In July, the Institute of Internal Auditors published an update to its 2013 Three Lines of Defense model for risk management.[1] The new version, simply called the Three Lines Model, makes numerous substantial changes in an attempt to modernize and build greater flexibility into the model. The results are mixed, but with more positives than negatives...

  8. Back to basics: OIG Supplemental Compliance Program Guidance for Hospitals—Risk areas

    Compliance Today - October 2020  | Author: Catherine Boerner  | October 2020 

    The Office of Inspector General’s Supplemental Compliance Program Guidance for Hospitals[1] presented the fraud and abuse risk areas listed below that are particularly relevant to the hospital industry. Each hospital should carefully examine these risk areas and identify those that potentially affect the hospital...

  9. The compliance budget

    Compliance Today - October 2020  | Author: Margaret Hambleton  | October 2020 

    This month I want to talk about one of my least favorite subjects—the compliance budget. In a perfect world, a compliance budget would be developed after completing your annual risk assessment, the compliance program effectiveness analysis, and a review of the adequacy of prior year staffing to effectively audit, document, analyze, and act on the results of the compliance efforts (as highlighted in the Evaluation of Corporate Compliance Programs[1] ). A compliance officer would take the risk assessment, effectiveness evaluation, and staffing analysis to the board and present budget requirements to address the most significant risks and improve compliance program...

  10. The intersection of civil rights and the end-of-life care

    Compliance Today - October 2020  | Author: Nancy J. Beckley  | October 2020 

    Enforcement actions, Centers for Medicare & Medicaid Services memorandums, Office of Inspector General reports, and survey and certification guidance have given providers multiple touch points to update their compliance risk assessment, develop additional compliance monitors, and determine opportunities for specialty audits. The U.S. Department of Health & Human Services’ Office for Civil Rights (OCR) issued guidance early on in the public health emergency, easing enforcement actions while at the same time asking providers to exercise caution.[1] There was no change in the laws that OCR enforces, and OCR has been swift to respond to complaints ending in favorable outcomes for...

  11. Human resources monitoring

    Compliance Today - October 2020  | Author: John Falcetano  | October 2020 

    All healthcare organizations are required to comply with a wide range of human resources (HR) regulations. HR compliance is essential for organizations to be successful in today’s regulatory environment. The HR function is responsible for identifying, hiring, and retaining individuals needed to allow organizations to carry out their strategies and meet their goals, objectives, and missions...

  12. Data breaches: Don't lose sight of the individual

    Compliance Today - October 2020  | Author: Jay P. Anstine  | October 2020 

    In June, a man was arrested in Detroit, Michigan, and accused of stealing the data of 65,000 employees.[1] The man, Justin Sean Johnson, is under indictment related to conspiracy, wire fraud, and aggravated identity theft charges tied to a 2014 hack of the human resources databases at the University of Pittsburgh Medical Center. Prosecutors have alleged that Johnson conspired with others in South America to sell stolen data (e.g., names, addresses, Social Security numbers) on the dark web. It is further alleged the actions resulted in the filing of false tax returns to the tune of $1.7 million...

  13. Is your hotline 'hot?' Approaches to improving and promoting your compliance hotline

    Compliance Today - October 2020  | Author: J. Veronica Xu  | October 2020 

    “Why is it called a ‘hotline?’ Is your hotline ‘hot?’” I was recently asked by a nine-year-old language enthusiast. Although I was not completely speechless, there was a slight delay in my response because his questions prompted me to ponder. According to the Merriam-Webster dictionary, “hot” means “having a relatively high temperature,” “currently popular or in demand,” “unusually lucky or favorable,” and “very good,” among other things. Simply put, it can be interpreted as “popular, attractive, appealing, and inviting.” Despite the fact that “hotline” is actually defined by Merriam-Webster as “a direct telephone line in constant operational readiness so as...

  14. What healthcare organizations can do to stay compliant in the era of marijuana legalization

    Compliance Today - October 2020  | Authors: Dawn Irizarry, Carolina Schwalbach  | October 2020 

    In 1996, California was the first state to legalize medical use of marijuana by enacting the Compassionate Use Act,[1] which was designed to provide certain legal protections to patients, caregivers, and physicians. Under the Compassionate Use Act, physicians who prescribe or recommend the use of smoked marijuana for medical reasons, individuals who use marijuana for medical reasons, and caregivers who assist those patients when using cannabis for medical reasons are exempt from criminal prosecution. Since the passage of the Compassionate Use Act, all but four states in the US have passed similar legislation[2] and some have adopted more expansive laws...

  15. Taking the risk out of risk adjustment: Managing exposure for ACOs

    Compliance Today - October 2020  | Authors: Andrea D. Kelly, Heidi Lopez  | October 2020 

    The Medicare Shared Savings Program (MSSP) has provided increased opportunity for providers opting into accountable care organizations (ACOs) to derive additional income for closely monitoring and coordinating the care of Medicare beneficiaries. In maintaining high-quality standards while controlling and reducing costs, ACOs and their member providers are in a position to share in any savings realized by the Medicare program...

  16. Using SMART goals to measure the effectiveness of your compliance program

    Compliance Today - October 2020  | Author: Cindy Chung  | October 2020 

    We all know that there is no one-size-fits-all compliance program. However, when it comes to building a compliance program, there is no need to recreate the wheel. The Office of Inspector General’s Seven Elements of an Effective Compliance Program (seven elements) provide guidelines for any healthcare organization to build an effective compliance program that fits their organization’s unique issues and needs.[1] As a reminder, the seven elements include:...

  17. Breaking down the walls: Strategies to reduce compliance risk in the revenue cycle

    Compliance Today - October 2020  | Authors: Dawn E. Crump, Emilie R. Sturm  | October 2020 

    Throughout the history of healthcare in the United States, departments have worked within their own silos. Today, with increased managed care recipients, the shift to value-based reimbursement, and unprecedented demands due to COVID-19, a team-based approach is more important than ever. Collaboration between compliance officers and revenue cycle leaders is critical to reduce risk, bridge communication gaps, and promote teamwork while also supporting billing integrity and revenue recovery for the organization. With increased requests for audits and access to electronic health records (EHRs), departments must find a way to work together to create efficiencies, promote compliance, and retain revenue...

  18. Monitoring for privacy compliance with the use of AI in healthcare organizations

    Compliance Today - October 2020  | Author: Robin Singh  | October 2020 

    The artificial intelligence (AI) healthcare space, by 2021, according to an Accenture study, is slated to reach $6.6 billion.[1] AI is continuing to play key roles across sectors and has emerged as an invaluable tool in healthcare. While the benefits of AI are many in healthcare, a lot of debate centers around the increasing use of AI in healthcare and, consequently, data privacy concerns.[2]...

  19. International Competition Network releases guidance on cross-border leniency applications

    Compliance Today - October 2020  | Author: Sascha Matuszak  | October 2020 

    The International Competition Network, an informal network advocating for effective competition of law enforcement, issued a guidance document outlining best practices for international leniency applications. “Leniency” in this case refers to applications by organizations for reduced fines in exchange for cooperating with ongoing investigations...

  20. Sculptor Capital Management Inc. agrees to pay fine to resolve a Foreign Corrupt Practices Act case

    Compliance Today - October 2020  | Author: Sascha Matuszak  | October 2020 

    In a case that has remained unresolved for almost a decade, Sculptor Capital Management Inc., formerly Och-Ziff Capital Management, agreed to pay investors in a Congolese mine, who were victims of a bribery scheme in 2016, restitution.[1]...

  21. A review of recent healthcare enforcement actions

    Compliance Today - October 2020  | Author: Sascha Matuszak  | October 2020 

    A series of enforcement actions in July resulted in hundreds of millions of dollars in fines for organizations in the healthcare industry. Several cases were brought to court under the qui tam provisions of the False Claims Act, in which private parties can bring suit on behalf of the government and are eligible to share in any recovery...

  22. CMS issues proposed rule updating end-stage renal disease payment policies

    Compliance Today - October 2020  | Author: Sascha Matuszak  | October 2020 

    On July 6, the Centers for Medicare & Medicaid Services (CMS) released details on a proposed rule[1] that would make changes to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), as well as updates to the acute kidney injury dialysis payment rate and the ESRD Quality Incentive Program...

  23. Meet Barbara J. Vimont: A lifetime of compliance

    Compliance Today - September 2020  | Author: Charles E. Colitre  | September 2020 

    CC: Barb, before you became involved in compliance, I know you were working in medical records. Tell us about how that transition came about...

  24. The impact of the final ONC and CMS interoperability rules on health information

    Compliance Today - September 2020  | Authors: Michaela Andrawis, Lyra Correa, Miriam Ricanne Swedlow  | September 2020 

    On March 9, 2020, the U.S. Department of Health & Human Services (HHS), through the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS), published separate, but related, final rules implementing the interoperability and patient access provisions of the 21st Century Cures Act (Cures Act).[1] The earliest compliance date for the rules is November 2, 2020,[2] and healthcare entities will find that there is a lot to do between now and then...

  25. Tackling health IT challenges with a proven risk management strategy

    Compliance Today - September 2020  | Authors: Gerry Blass, Jason Tahaney  | September 2020 

    Whether we want to believe it or not, healthcare data breaches are prevalent throughout the industry. Even more alarming, an evaluation of recent cyber and ransomware attacks indicates that the size or type of healthcare organization is immaterial to would-be attackers. Hospitals, clinics, long-term and elderly care providers, dental and optometry practices, plastic surgeons, and medical testing facilities have all experienced cyberattacks since 2016.[1] In fact, a Ponemon Institute study cited that 89% of healthcare organizations have experienced a data breach.[2]...