Fraud & Abuse
The FDA regulationson human subject protection and Institutional Review Boards(IRBs) provide guidance to protect the rights, safety, and welfare of subjects who participate in FDA-regulated clinical investigations. The regulations conform with the requirements set forth by the Department of Health and Human Services (HHS) Federal Policy of Human Research Subjects(45 CFR 46, part A). In order to reduce confusion and burdens associated with complying with both the FDA regulations and the HHS policies regarding human subject protections, the FDA is revising the current “common rule”.
Judge P. Kevin Castel of the U.S. District Court for the Southern District of New York entered an Order for Final Judgment and Consent Order for Final Judgment (“the Orders”) early this month, resolving charges of a Commodity Futures Trading Commission (the “CFTC”) Complaint against a New York Corporation, Gelfman Blueprint Inc. (“GBI”) and its Chief Executive Officer, Nicholas Gelfman. The CFTC’s complaint, filed in January of 2017, marked the first anti-fraud enforcement action involving Bitcoin filed by the Commodity Futures Trading Commission. The Orders found that from approximately January of 2014-January 2016 Defendants Gelfman and GBI, through its officers and agents and employees, operated a Bitcoin Ponzi scheme in which they fraudulently solicited more than $600,000 from at least 80 customers.
In the age of digitization, data seems less secure than ever. Public companies constantly attempt to safeguard both personal and financial data, yet their efforts fail due to new outbreaks of malicious encryption viruses and persistent email phishing attempts. Data breaches and cyber fraud carry severe financial implications for public companies who fall victim to these types of attacks. But a new Securities and Exchange Commission (SEC) report says that public companies that are easy targets of cyber scams could also be in violation of federal securities laws and accounting regulations that call for firms to safeguard their assets. Although the SEC has issued its warning to public companies about the compliance and financial risks posed by cyber fraud, many companies are still struggling to implement effective protections against newly-evolved forms of cyber-attacks.
Protected Health Information is seeing a surge of breaches on the cyber security front due to contractor error. It’s also impacting the most consumers in comparison to other data breaches and, in some cases, has the power to cause chaos in national infrastructure. Advances in technology and compliance measures can stem the tide and protect the most valuable information in consumers lives.
The Centers for Medicare and Medicaid Services (CMS) have a multitude of resources to detect and protect against fraud and abuse in claims. Particularly, CMS has at least six types of contractors that provide different roles in the prevention, detection, and reporting of fraud and abuse in healthcare. This list includes Recovery Auditors, which serve to reduce fraud and abuse by detecting and collecting overpayments from entities and Comprehensive Error Rate Testing (CERT) Contractors, which determine rates of improper payments by reviewing claims under Medicare Fee-For-Service (FFS). Another auditor that providers should be particularly mindful of are the Zone Program Integrity Contractors (ZPICs). This article is an overview ZPICS, its role in Medicare, and outlines the steps providers should take when faced with an audit by ZPICs.
One month after the largest health care fraud enforcement action was taken, the Assistant Attorney General, Brian A. Benczkowski, of the Justice Department’s Criminal Division, announced the addition of the Newark/Philadelphia Regional Medicare Strike Force. The newly added 11th Medicare Strike Force will largely focus on healthcare fraud that is contributing to the opioid epidemic.
Finance Director for UnitedHealth Group brought qui tam suit against UnitedHealth Group, Inc. alleging that the organization upcoded risk adjustment data resulting in increased payments (more than $1.14 billion) to UnitedHealth Group. The Department of Justice (DOJ) intervened in the case, yet UnitedHealth Group was successful in getting the primary False Claims Act Claims dismissed by arguing that the Centers for Medicare & Medicaid Services (CMS) would not have refused to make the adjustment payments had they known of the errors in the risk adjustment. The Escobar materiality standard helps clarify threshold level of risk to Managed Care Providers in attesting to their risk adjustment payments; the falsities must have had an impact on the respective payment.
One of the most difficult things many of us will experience in our lifetime is the death of a loved one. Whether unexpected or a drawn out farewell, it is a situation no one can be full prepared to handle. In this moment of extreme vulnerability, most people begin the process of planning a funeral. Society has placed an incredible amount of faith in funeral directors to make sure the wishes of our loved ones are met and insure a memorable service for the living. However, this is not always the case.
On August 30, 2017, Trump signed Proclamation 9632 declaring September 2017 as National Preparedness Month, encouraging “all Americans… take action to be prepared for disaster or emergency by making and practicing their plans,” also citing that fewer than half of American families report having an emergency response plan. While it is important to have a disaster plan in place for your family to take care of their physical needs, it is also vital to be prepared for the possibility of scams and fraudulent activity in the wake of a natural disaster such as Hurricane Harvey.
This summer I had the opportunity to intern with the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) in Washington, DC. I thoroughly enjoyed my time with OIG, and I learned a great deal about health care fraud, waste, and abuse. In spending my summer with OIG, I had a glimpse into the powerful regulatory bodies that protect the health care market from abuse. As I move forward with my career in regulatory work, I will take with me the invaluable experiences and skills from my internship.