Pharmacy claim reversals can be costly. Not only can they have an immediate impact on pharmacies’ cash flow; but, in many cases, they can lead to additional consequences as well. Pharmacies accused of improperly billing...more
Federal law enforcement agencies, including the U.S. Drug Enforcement Administration (DEA), have amped up their investigations into the drug ketamine in recent years, likely in reaction to some high-profile overdose deaths....more
8/1/2024
/ Controlled Substances ,
Controlled Substances Act ,
DEA ,
Defense Strategies ,
Drug Possession ,
Government Investigations ,
Health Care Providers ,
Internal Investigations ,
Litigation Strategies ,
Physicians ,
Prescription Drugs ,
Risk Assessment ,
Risk Mitigation ,
White Collar Crimes
The healthcare industry relies heavily on whistleblowers to bring fraudulent conduct and other forms of waste and abuse to the attention of regulators, law enforcement, and the public in general. If you have found signs of...more
6/25/2024
/ Anti-Retaliation Provisions ,
Defense Strategies ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Retaliation ,
Whistleblower Awards ,
Whistleblower Protection Policies ,
Whistleblowers ,
White Collar Crimes ,
Wrongful Termination
All healthcare providers and other businesses in the healthcare industry need to comply with the Anti-Kickback Statute (AKS). The AKS imposes criminal penalties for knowing and willful violations, and even inadvertent...more
Lots of health care service providers find themselves in the position of needing to file a Medicare appeal. Despite the systematic nature of modern Medicare billing, wrongful denials remain common, and errors during Medicare...more
3/26/2024
/ Auditors ,
Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Denial of Insurance Coverage ,
Health Care Providers ,
Medicare ,
Medicare Appeals ,
OMHA ,
Physician Medicare Reimbursements ,
Redeterminations ,
Reimbursements
Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned...more
Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more
4/19/2023
/ Advertising ,
Criminal Prosecution ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Investigations ,
Marketing ,
Novo Nordisk ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs
As a doctor or other licensed medical professional, the prospect of losing your license to practice medicine can be overwhelming. But, to protect your license—and your career—to the fullest extent possible, you need to act...more
3/21/2023
/ Defense Strategies ,
Health Care Providers ,
Healthcare Fraud ,
Investigations ,
Licensing Boards ,
Medical License ,
Medical Malpractice ,
Physicians ,
Professional Disciplinary Actions ,
Professional Liability Insurance ,
Professional Responsibility ,
State Medical Board
The U.S. Food and Drug Administration (FDA) has broad authority to evaluate and approve drugs for medical use or prescription drugs. It also has the authority to investigate fake or counterfeit medicines and substances in the...more
Similar to other types of healthcare entities, clinical laboratories have been facing enhanced scrutiny from federal authorities over the past couple of years. While this is due in part to fraud concerns related to COVID-19...more
3/8/2023
/ Anti-Kickback Statute ,
Civil Liability ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Criminal Liability ,
Defense Strategies ,
Department of Justice (DOJ) ,
Evidence ,
False Billing ,
FBI ,
Health Care Providers ,
Healthcare Fraud ,
Internal Audit Functions ,
Investigations ,
Risk Assessment
The U.S. Department of Justice (DOJ) has recently taken a renewed interest in management services organizations (MSOs), including physician-syndicated MSOs in which physician-owners provide medical services in exchange for...more
Hospitals are subject to numerous state and federal laws, rules, and regulations, like all healthcare organizations. However, due to their outsized role in our nation's healthcare system, the healthcare industry often faces...more
As a licensed physician, facing a medical board investigation could mean that your career is on the line. Even though you spent years in medical school and in residency, and even though you may have spent decades honing your...more
As a licensed physician in Texas, facing a Texas Medical Board (TMB) investigation can present significant risks. Depending on the allegations underlying the investigation, your medical license could be in jeopardy—and you...more
Facing a Qlarant audit is a serious matter for healthcare providers and other entities that bill Medicare or Medicaid. While the Qlarant Foundation is a non-profit entity, Qlarant Integrity Solutions is a profit-driven entity...more
Medical professionals, patients, and others can commit healthcare fraud by deceiving the healthcare system, such as providing medically unnecessary services, in order to get unauthorized benefits or payments. Facing...more
Yesterday, the U.S. Department of Justice (DOJ) announced that it has filed charges against 36 defendants in relation to an alleged health care fraud scheme that resulted in approximately $1.2 billion in fraudulent payments....more
7/21/2022
/ Centers for Medicare & Medicaid Services (CMS) ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FBI ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Medicare Beneficiaries ,
Physician Medicare Reimbursements ,
Physicians ,
Telehealth ,
Telemarketing ,
Telemedicine
Nearly all healthcare providers will face an audit (if not multiple audits) during their careers. Federal agencies such as the U.S. Department of Health and Human Services (HHS) routinely audit healthcare providers for...more
On June 27, 2022, the U.S. Supreme Court issued an important decision for doctors who have been convicted of violating the federal Controlled Substances Act in connection with the nation’s opioid crisis. In Ruan v. United...more
7/5/2022
/ Burden of Proof ,
Controlled Substances ,
Controlled Substances Act ,
Criminal Convictions ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Health Care Providers ,
Opioid ,
Pharmaceutical Industry ,
Prescribing Authority ,
Prescription Drugs ,
Ruan v United States ,
SCOTUS
The Centers for Medicare and Medicaid Services (CMS) and its audit contractors have recently increased their use of Targeted Probe and Educate (TPE) audits to target providers suspected of improperly billing Medicare. While...more
6/21/2022
/ Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Criminal Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Medical Billing Codes ,
Medical Records ,
Medicare ,
Medicare Administrative Contractors (MAC) ,
Medicare Appeals ,
Medicare Fraud ,
Penalties ,
Physicians ,
Targeted Probe and Education (TPE) audit
Over recent years, the federal government has shown an increased interest in bringing healthcare fraud prosecutions. In fact, in 2020 alone, the federal government opened 1,148 new criminal healthcare fraud investigations,...more
Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing.
These federal investigations can be surprising and confusing for lab...more
4/5/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Liability ,
CLIA ,
Clinical Laboratories ,
Criminal Liability ,
Defense Strategies ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
FBI ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Fraud ,
Investigations ,
OIG ,
Penalties ,
Physicians ,
Stark Law
The COVID-19 pandemic increased the business opportunities available to clinical labs, including molecular and respiratory labs. As the nation—and the world—struggled to develop adequate testing infrastructure, the federal...more
1/19/2022
/ Audits ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Defense Strategies ,
Department of Health and Human Services (HHS) ,
FBI ,
Health Care Providers ,
Healthcare Fraud ,
Investigations ,
Medical Billing Codes ,
Medical Necessity ,
OIG ,
Patient Referrals ,
Physicians
For diabetic patients and the doctors who treat them, blood sugar levels are crucially important. However, the traditional method of testing one’s blood sugar with a pin-prick is undesirable for many patients, which leads to...more
The federal government has recently made clear its intention to go after healthcare providers who provide amniotic injections to certain Medicare and Medicaid recipients. Over recent years, the federal government has...more
10/26/2021
/ Anti-Kickback Statute ,
Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Investigation Demand ,
Civil Liability ,
Criminal Liability ,
Defense Strategies ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
False Claims Act (FCA) ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Physicians ,
Stark Law