In today’s complex healthcare landscape, whistleblower claims are a major source of regulatory and legal risk for organizations. Last year saw a record number of “qui tam” claims filed under the False Claims Act. While...more
In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more
The compliance officer is one of the most important positions within a healthcare organization, but also one of the most challenging. You’re expected to be a teacher, a coach, a project manager, a good listener, and a role...more
5/22/2025
/ Audits ,
Chief Compliance Officers ,
Compliance ,
Corporate Governance ,
Employees ,
Ethics ,
Health Care Providers ,
Healthcare ,
Healthcare Workers ,
Policies and Procedures ,
Risk Management ,
Training
In a recent False Claims Act case, a long-term care pharmacy and consulting services provider was found liable for submitting false claims to the government, resulting in a jury verdict of over $135 million in damages. The...more
If your organization uses Electronic Health Records (EHRs), the recent updates to the SAFER Guidelines (Safety Assurance Factors for EHR Resilience) are essential for helping you assess the potential safety issues posed by...more
5/8/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
EHR ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Risk Assessment ,
Risk Management
Cash-based practices, or providers who neither participate with nor bill insurers, are becoming increasingly common, especially in certain specialties such as primary care, women’s health, and mental health. While providers...more
5/1/2025
/ Beneficiaries ,
Compliance ,
Health Care Providers ,
Health Insurance ,
Healthcare ,
Insurance Claims ,
Medicare ,
Mental Health ,
Physicians ,
Regulatory Requirements ,
Reimbursements
Effective May 1, 2025, the Section 1557 regulations require covered healthcare providers to take reasonable steps by May 1, 2025, to identify and mitigate the risk of discrimination when they use AI and other emergency...more
4/24/2025
/ Algorithms ,
Artificial Intelligence ,
Bias ,
Compliance ,
Discrimination ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Regulatory Requirements ,
Risk Management ,
Section 1557
Drug diversion can pose serious risks to patients, employees, and organizations. Any provider who stores, transports, or dispenses controlled substances should have a robust program designed to deter drug diversion and to...more
Delegated credentialing for telehealth providers has become commonplace since the Centers for Medicare & Medicaid Services (CMS) relaxed the Medicare Conditions of Participation for hospitals more than 10 years ago. Delegated...more
Compliance training is one of the most important responsibilities of the compliance officer. A provider’s best defense to non-compliance is well-trained employees who understand and follow your policies....more
Healthcare providers often have a detailed policy outlining when a minor may consent to care and when a parent or legal guardian’s consent is needed. Situations can arise in the treatment of minors that can make administering...more
Healthcare providers often have a detailed policy outlining when a minor may consent to care and when a parent or legal guardian’s consent is needed. Situations can arise in the treatment of minors that can make administering...more
On February 25, 2025, President Trump signed an Executive Order directing federal agencies to “rapidly implement and enforce” federal healthcare price transparency regulations....more
Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more
3/3/2025
/ Compliance ,
Compliance Monitoring ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
OIG ,
Policies and Procedures ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management
In January, the Department of Justice released its annual fraud statistics summarizing health care fraud settlements and judgments during the 2024 fiscal year. Last year, there were over $2.9 billion in fraud settlements and...more
2/27/2025
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Physician Payments ,
Physicians ,
Settlement ,
Stark Law ,
Whistleblowers
It is not uncommon for healthcare providers to want to offer employees a discount on their services as a way to show their appreciation and as an added benefit to retain and attract candidates. While these discount programs...more
“Almost every stage of modern healthcare relies on stable and secure computer and network technologies.”
The above is a direct quote from the Office of Civil Rights for Health & Human Services (“OCR”) in its proposed...more
1/31/2025
/ Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Security ,
Electronic Protected Health Information (ePHI) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Health Technology ,
Healthcare ,
HIPAA Security Rule ,
OCR ,
Patient Privacy Rights ,
Risk Management
As we routinely discuss on the podcast, much of the success of an organization’s compliance program depends on its culture. Creating and fostering a compliance-minded culture can help ensure employees report suspected...more
Providers are required by federal law to return Medicare and Medicaid overpayments within 60 days of identifying the overpayment or they can be liable under the False Claims Act. Since 2016, providers have relied on Centers...more
As we start a new year, January is a great time to plan ways to refresh your compliance programming for the upcoming year. Compliance training and activities can become stale. They often take a backseat to the day-to-day...more
As the ultimate decision-maker for your organization, your governing body needs to understand compliance and appreciate the compliance risks facing the organization as well as what is needed to mitigate those risks. This...more
Last month the Office of Inspector General for the U.S. Department of Health & Human Services (OIG) released its first industry-specific compliance program guidance aimed at nursing facilities (both skilled and non-skilled)....more
Holiday gifts are a common marketing tool used by many businesses; however, in healthcare, they can create compliance issues. Most healthcare providers have a gift policy that limits the type of gifts and other business...more
The Centers for Medicare & Medicaid Services (CMS) is in the midst of an off-cycle revalidation process for all Medicare-participating skilled nursing facilities (SNFs), requiring them to submit much more information...more
In September, the United States Department of Justice (DOJ) updated its corporate compliance program guidance which outlines criteria to look for in determining whether an organization’s compliance program is “adequate and...more