Our representation of behavioral health and substance abuse programs has required us to stay in tune to issues involving special confidentiality of patient records under 42 CFR Part 2, also known as the SAMHSA regulations The...more
Congress has activated a new Anti-Kickback law known as Eliminating Kickbacks in Recovery Act of 2018 (commonly referred to as EKRA). The new Anti-Kickback law applies to arrangements involving recovery homes, clinical...more
6/14/2019
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Criminal Prosecution ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Reform ,
Opioid ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Safe Harbors ,
Substance Abuse
The Affordable Care Act requires any person who has received an overpayment from certain defined government health programs to report and return the overpayment within 60 days after the overpayment is identified. If an...more
The Department of Justice (DOJ) along with other health care fraud enforcement agencies, continue to send strong signals that they want businesses to police themselves for potential compliance issues and self-disclose where...more
5/29/2019
/ Compliance ,
Cooperation ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Government Investigations ,
Health Care Providers ,
Inspector General ,
New Guidance ,
Remediation ,
Self-Disclosure Requirements
How Are Compliance Budgeting and Compliance Officer Autonomy Tied Together When Assessing Compliance Effectiveness?
The Department of Justice (“DOJ”)’s compliance program evaluation identifies the need to allocate...more
5/24/2019
/ Board of Directors ,
C-Suite Executives ,
Chief Compliance Officers ,
Compliance ,
Corporate Officers ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Internal Controls ,
Regulatory Oversight ,
Risk Assessment ,
Risk Management ,
Senior Managers
HIPAA, as a body of regulations protecting the confidentiality of patient health care information, has been branded very effectively. Most staff at your average health care facility know about HIPAA and that it protects the...more
The Criminal Division of the United States Department of Justice (DOJ) recently released an update (April, 2019) to its Evaluation of Corporate Compliance Programs (Evaluation). The Evaluation was first introduced in 2017 to...more
Well, it’s a start. New Medicare rules kicked in starting January 1, 2019 that are aimed at focusing less provider time on paperwork and more on patient care in inpatient rehabilitation facilities. Any change that reduces...more
A recent Advisory Opinion (Advisory Opinion 18-03) from the Office of Inspector General (OIG) of the Department of Health and Human Services addresses potential kickback issues involved in the donation of telehealth...more
A recent Office of Inspector General (OIG) advisory opinion approved a proposal under which a hospital has established a caregiver center that provides or arranges for free or reduced-cost support services to caregivers in...more
8/30/2018
/ Alternative Fee Arrangements ,
Anti-Kickback Statute ,
Caregivers ,
Civil Monetary Penalty ,
Free Health-Related Services ,
Health Care Providers ,
Inducements ,
Low-Income Issues ,
Medicaid ,
Medicare ,
OIG ,
Remuneration
The Wisconsin Supreme Court has issued a ruling in the case of Mayo v. Wisconsin Injured Patients and Families Compensation Fund. The Supreme Court’s decision, which was handed down on June 27, 2018, overturned a lower court...more
This may not be obvious to people who do not keep track of the Federal Trade Commission (FTC)/Department of Justice antitrust enforcement policy, but an enforcement action has never been published involving an Accountable...more
6/21/2018
/ ACOs ,
Anti-Competitive ,
Antitrust Division ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Market-Sharing ,
Proposed Regulation ,
Risk Management ,
Rural Areas
As health care attorneys we are often called upon to consider the antitrust implications in a variety of contracts and transactions. For example, the establishment of clinically integrated health care networks requires...more
6/6/2018
/ Antitrust Provisions ,
Competition ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Healthcare ,
Hospital Mergers ,
Hospitals ,
No-Poaching ,
Price-Fixing ,
Trump Administration
The state of Michigan has enacted a number of separate pieces of legislation to address the opioid epidemic. Most of these laws are directed at controlling the prescribing relationship between a physician and a patient....more
The Department of Justice (DOJ) recently announced the guilty plea of two individual alcohol and substance abuse treatment center owners for their participation in what the DOJ labeled a “multi-million dollar health care...more
5/24/2018
/ Anti-Kickback Statute ,
Bribery ,
Controlled Substances ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Drug Treatment ,
Guilty Pleas ,
Health Care Providers ,
Kickbacks ,
Money Laundering ,
Opioid ,
Prescription Drugs ,
White Collar Crimes
One of the reasons compliance officers and health care attorneys read fraud settlements is to identify issues the government is focused on. The cases the government decides to pursue are very indicative of the areas of fraud...more
5/18/2018
/ Anti-Kickback Statute ,
Controlled Substances Act ,
DEA ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Medicare ,
Opioid ,
Patient Referrals ,
Pharmaceutical Industry ,
Prescription Drugs ,
Stark Law ,
Whistleblowers
At a recent Health Care Compliance Association (HCCA) compliance institute, the Office of Inspector General announced it had launched a new resource portal focused on compliance issues. A trip to the OIG's web site, and sure...more
We are often asked to advise clients regarding the scope and content of Health Insurance Portability and Accountability (HIPAA) policies and procedures that are required to be maintained. HIPAA clearly requires health care...more
Conducting HIPAA Breach Risk Assessments -
The HIPAA rules relating to assessment of potential patient confidentiality breaches were changed in 2013. Specifically, on January 17, 2013, the Office of Civil Rights released...more
4/4/2018
/ Best Practices ,
Covered Entities ,
Data Breach ,
Encryption ,
Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
Patient Confidentiality Breaches ,
PHI ,
Policies and Procedures ,
Reporting Requirements ,
Risk Assessment ,
Risk Mitigation
If you navigate to the American Hospital Association (AHA) Interactive Town Hall of January 17, 2018, you can view a video in which Seema Verma, the current Administrator of the Centers for Medicare and Medicaid Services,...more
The opioid epidemic is different than other drug related social problems because, in many cases, addiction to opioids starts in the medical office or in the pharmacy; in most cases through the treatment of legitimate physical...more
The health care market has recently seen a resurgence in narrow network products. To a significant degree, the resurgence of these products has been driven by the need for managed care plans looking for new avenues to help...more
The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has released a report summarizing activities of State Medicaid Fraud Control Units (MFCUs or Units) for fiscal year 2016. The OIG is the...more
6/28/2017
/ Criminal Convictions ,
Department of Health and Human Services (HHS) ,
Employee Training ,
Employer Liability Issues ,
Fraud ,
Fraud and Abuse ,
Healthcare Fraud ,
Home Healthcare Workers ,
OIG ,
Personal Care Assistants ,
State Medicaid Programs
Failure to conduct a risk assessment before a hacking incident occurred resulted in a $400,000 settlement between the Office of Civil Rights (OCR) and a Federally Qualified Health Clinic (FQHC). The FQHC filed a breach...more
The 60-day repayment rule adopted as part of the Affordable Care Act is a very strong arrow in the quiver of federal enforcement agencies. Under the 60-day rule a known overpayment can become a False Claim if it is not repaid...more