Dec. 10, 2024
Dec. 10, 2024

Last month marked the 25th anniversary of the game-changing report, To Err Is Human: Building a Safer Health System. Released by the Institute of Medicine (now the National Academy of Medicine) on Nov. 29, 1999, the report ignited the modern patient safety movement after estimating that nearly 100,000 people die each year from medical errors.
Whether care has gotten any safer over the past two-and-a-half decades is for patient safety advocates, healthcare regulators, healthcare policy analysts, health services researcher, the public, the media, and others to decide. What is clear is that each day since (and before) the IOM released its infamous report, internal audit teams at hospitals and health systems across the country have been working tirelessly to identify and mitigate risks that not only threaten the quality and safety of patient care but every aspect of healthcare finance and delivery at their organizations.
This annual Top Risks report from Kodiak identified the top four risk domains and specific risks within those four domains this year based on input from:
Kodiak defines a risk domain or a specific risk as anything that might impede a healthcare organization’s ability to achieve its goals in critical areas. In 2024, the four top risk domains were:
Kodiak’s risk and compliance team compiled the following detailed descriptions of the risk domains, the specific risks within in each domain, and audits for internal audit teams to consider to mitigate the risks.

AI has powerful new abilities. When combined with other forms of AI, machine learning, and other technologies, it can streamline tasks through real-time consolidation of a complete array of clinical and financial information sources. It’s projected that through these new capabilities, AI could generate $1 trillion (about $3,100 per person in the U.S.) in improvements across the healthcare industry. Healthcare executives must weigh the benefits and risks of incorporating generative AI tools. Combining clinical/business judgement and clinical/business insights can help develop sustainable and equitable use cases. Using population-level data and broad data sets, generative AI can help tackle systemic issues such as accessibility, affordability, and equitable outcomes. This presents an opportunity and responsibility to make meaningful operational and financial improvements.

Compliance with the 340B drug discount program remains a top concern for healthcare organizations. Under the 340B program, eligible entities may take advantage of significant discounts in the cost of outpatient drugs, enabling them to stretch limited funds and provide more comprehensive services to low-income patients and their local communities. The 340B regulatory requirements are numerous and complex, and they often require substantial internal monitoring. Noncompliance can have significant negative financial risks ranging from regulatory penalties and manufacturer repayments to total removal from the 340B program.
Beginning in 2020, manufacturers began implementing policies refusing to provide or restricting 340B pricing for drugs dispensed through contract pharmacies. Currently, 39 pharmaceutical manufacturers have imposed distribution limitations on covered outpatient drugs dispensed through the 340B program, undermining the 340B drug pricing program.
The No Surprises Act protects patients covered under group and individual health insurance plans from receiving surprise medical bills when they obtain emergency services from out-of-network facilities. Noncompliance can result in civil monetary penalties for each violation. Additionally, uninsured or self-pay patients who receive a medical bill at least $400 more than the expected charges on the Good Faith Estimate can initiate the patient provider dispute resolution process, which can result in lost revenue for facilities and providers and negatively impact the reputation of the hospital organization.

Patient safety is of the utmost importance to healthcare provider organizations. It’s also a continuous journey. With nearly one in four patients admitted to a U.S. hospital experiencing an adverse event, it’s clear there is so much more work to do. To minimize the potential for patient harm, healthcare organizations need every tool at their disposal, and that includes clinical audits. These essential audits support the core aims of an organization’s patient safety efforts by improving the care experience for patients and caregivers, improving the health of the organization’s patient population, and reducing the per capita cost of care.
· Sterile processing
· Device disinfection
· Surgical safety (universal protocol)
· Behavioral health
· Coding optimization and compliance

Effective system access management is a critical component of a healthcare organization's overall security framework, ensuring that only authorized personnel can access sensitive systems and data. However, when access is not properly managed, it introduces significant risks to both the security of patient information and the integrity of healthcare operations. The risks associated with system access management extend across a variety of areas, including the timeliness of access provisioning and deprovisioning, performance of periodic access reviews, restricting access to the least privilege necessary, managing privileged access, and handling transfers of healthcare professionals between departments or roles.

Every healthcare organization is different. A top risk domain for one healthcare organization might not be a top risk domain for another organization. That’s why it’s important for a healthcare organization to know its specific risks. In doing so, internal audit teams can focus their efforts on risk domains that give them the biggest return on risk.
Kodiak offers both proprietary technology and deep industry experience to help organizations do just that. Please contact us today to discuss how our risk and compliance team can use our technology, deep expertise, and experienced resources to support your organization’s 2025 internal audit and compliance work plans and address these top risk areas.
Kodiak has your back. Visit the risk and compliance section of our website to learn more about how we can work together to increase your return on risk.
Since the COVID-19 pandemic, healthcare organizations have faced lost revenues due to changes in the service delivery models and higher employment and supply costs. The ability to bill and collect for all services provided has become even more important. Inefficiencies in revenue cycle operations and performance could result in delayed or reduced cash flow, unnecessary overhead, negative patient experience, and reduction in community benefit. Noncompliance with government billing regulations and payer contract requirements could result in lost reimbursement, fines, and exclusion from participation in governmental programs. These challenges might be magnified for organizations that rely on third-party vendors to provide some or all their revenue cycle functions on an outsourced basis and, therefore, have less day-to-day oversight and control.
Similarly, risks increase for healthcare organizations relying on automated claims billing systems for which they have limited visibility to or control over functionality. Newer electronic medical record systems are incorporating “clinically driven revenue cycle” processes whereby the billing functions are triggered by clinician’s actions/documents. In addition, commercial payers might aggressively negotiate reimbursement terms or deny reimbursements in markets with little payer competition or where healthcare organizations wield minimal buying power.
Key business processes such as accounts payable are critical to every healthcare organization. While these processes are highly visible and typically well-managed, when significant changes occur within the AP process, e.g., leadership or employee turnover or staff reductions, or within the overall organization, e.g., changes in operating procedures due to a pandemic, implementation of a new enterprise resource planning system, or organizational consolidation or centralization post-merger), fraud risks might increase due to changes in people, processes, or technology, or suspension/elimination of key internal controls.
Specific risks include fraudulent or unauthorized payments to existing vendors or employees, creation of and payment to fictitious vendors, and inappropriate or unauthorized updates to vendor master data causing payments to be diverted from the correct vendor.
The workforce challenges that healthcare organizations face include recruiting, hiring, and retaining qualified employees as demand for healthcare services increases due to the aging U.S. population and the competition for healthcare workers intensifies. Workers leaving the healthcare sector due to pandemic-related burnout and accelerated retirements have only worsened the challenge over the past three years.
One way healthcare organizations have responded is through increased reliance on travel nurses. Some formed their own travel nurse programs to limit related costs. Others offered increased benefits or incentives to retain workers. Some of those that could not respond with creative solutions reduced or eliminated services or service lines at select sites of care.
The situation has created several specific risks that hospitals and health systems historically have not had to deal with before on such a scale. These risks include:
Physician contracts continue to be a significant risk area for healthcare organizations due to the high operational, reputational and financial exposures. Risks include violating federal fraud and abuse statutes, e.g., Stark, false claims, and anti-kickback statutes, through payments to physicians without a contract, in excess of contractual amounts, and/or above fair market value; physicians using hospital space without proper lease or compensation to the health system; recruitment arrangements that do not meet regulatory requirements; and failure to monitor compliance with contract and recruitment arrangement terms.
Stricter technical price transparency requirements took effect in 2024, including:
There are additional federal requirements that will go in effect Jan. 1, 2025, as Estimated Allowed Amount, Modifier, Drug Unit of Measurement, and Drug Type of Measurement become required data elements in MRF.
Because price transparency files are required to be publicly posted, CMS is able to remotely validate compliance and has begun publicly citing hospitals for noncompliance. Monetary fines can be imposed and impact a hospital’s reputational risk stemming from public criticism if a hospital knowingly does not comply with requirements or revenue cycle bills do not match charges posted on a hospital’s website.
Medicare provides coverage for a wide variety of medical services, but that coverage is not absolute. There are circumstances where services generally covered by Medicare are denied as either not reasonable or necessary, or as constituting custodial care. Healthcare organizations must notify a beneficiary in advance by providing an Advance Beneficiary Notice when the provider believes that items or services will likely be denied because of the above criteria. If the provider does not deliver a valid ABN to the beneficiary, the beneficiary cannot be billed, resulting in lost revenue to the healthcare organization.
If an ABN is used inappropriately to collect from a Medicare beneficiary, a refund to the beneficiary may be required. Refunds must be made within specified time limits; healthcare organizations who knowingly fail to make a required refund within these time limits may be subject to civil money penalties and/or exclusion from the Medicare program.
A healthcare organization’s medical staff bylaws should require that medical staff are credentialed and privileged upon new hire and at least every two years. Procedures to flag all Licensed Independent Practitioners, i.e., any individual permitted by law and by the organization to provide care, treatment and services, without direction or supervision, requiring credentialing and re-credentialing and the tracking of credentialing and re-credentialing activities are critical to make certain it is done and completed timely. Both CMS and Joint Commission have developed detailed guidance. Successful credentialing thus requires sound initial assessment procedures, as well as access to comprehensive, reliable and practitioner-specific performance data.
Organizations can be at risk of lawsuits alleging negligent credentialing practices if privileges are approved without fully verifying an applicant’s qualifications and proficiency or professional liability insurance coverage or licensing lapses in off years of the biennial credentialing process.
Key considerations for business continuity in healthcare organizations include the importance of Enterprise Resilience, which is a collaborative effort across departments to recover and continue operations from the onset of a disruption through to the restoration of normal operations. Enterprise Resilience planning ensures the organization can recover and maintain essential business functions, provide safe and quality patient care, and safeguard sensitive data in the event of system downtime.
Additionally, the organization must prioritize the restoration of applications that are vital to patient care and safety. Not all systems are equally essential, so a clear framework for application recovery prioritization is necessary. Applications such as electronic health records, patient monitoring systems, and other key healthcare tools must be restored first, while less critical systems can be brought online later. Enterprise Resilience also includes risk mitigation strategies such as business impact analyses, downtime procedures, and regular testing and training to ensure staff are prepared to respond effectively to any disruptions. Failure to address these risks could undermine patient safety and hinder the ability to comply with legal, regulatory, and financial obligations.
Biomedical devices are increasingly connected to the internet, which exposes them to cyberattacks that can compromise patient safety and disrupt care. Attacks can lead to device malfunctions that harm patients, theft of sensitive data for identity theft or blackmail, and disruptions in treatment. Older medical devices are especially vulnerable due to outdated software, lack of support, and regulatory challenges. Outdated software often contains known vulnerabilities that attackers can exploit, while lack of manufacturer support means these vulnerabilities remain unpatched. The complexity of medical devices and the time-consuming FDA approval process for software updates further complicate security.
Many healthcare organizations still lack mature governance over medical device procurement, vendor oversight, and risk management. Insufficient security controls like poor access management, weak passwords, and inadequate network segmentation increase risks to patient safety and organizational security.
Cybersecurity threats continue to evolve rapidly, with third-party incidents increasingly causing significant impacts on healthcare organizations. The lack of mature controls governing cybersecurity remains a top risk, particularly as the likelihood of an attack causing extended downtime has grown significantly in recent years. While layered technology solutions and the information security department form the first line of defense against these threats, the consequences of a cyberattack can span across the entire organization, affecting both IT infrastructure and business operations. Risks include system downtime, which hampers the ability to provide patient care, the exposure of sensitive data, employees falling victim to social engineering tactics, and attacks originating from trusted third parties, such as vendors or software providers. Additionally, healthcare organizations face challenges in quickly recovering from a substantial IT threat, and the risks associated with unauthorized access to systems and data continue to rise. In addition to the direct impact on patient care and operations, cyber threats can lead to significant financial losses, legal liabilities, and reputational damage.
Data governance refers to the comprehensive management of an organization’s data through well-defined procedures and plans. It ensures that both structured and unstructured data are accessible, accurate, secure, and usable. Effective data governance is considered both high risk and high reward, especially when data can be fully leveraged to enhance decision-making and analytics capabilities. Weak internal controls in data governance can compromise the reliability of data used in decision-making and heighten the risk of unauthorized or inappropriate data disclosure.
A strong data governance program provides essential safeguards to ensure data security, privacy, accuracy, accessibility, and usability. Common risk areas include the potential for extensive patient data to reside on personal devices, unmanaged network shares, clinical devices, and various third-party platforms.
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