The Office of Inspector General (OIG) and other Federal agencies charged with responsibility for enforcement of Federal law have emphasized the importance of voluntarily developed and implemented compliance plans. The government, especially the OIG, has a zero- tolerance policy towards fraud and abuse and uses its extensive statutory authority to reduce fraud in Medicare and other federally funded health care programs. The OIG believes that through a partnership with the private sector, significant reductions in fraud and abuse can be accomplished. Compliance plans offer a vehicle to achieve that goal. The OIG has provided a model compliance plan for clinical laboratories to assist laboratory providers in crafting and refining their own compliance plans.
The OIG suggests that the comprehensive compliance program should include the following elements:
Laboratory buyers and sellers considering a sale or purchase should have knowledge of issues that can affect the transaction. Due diligence requires conducting measures that provide a buyer confidence that the laboratory for sale is being accurately represented by the seller.
The transaction requires consideration, communication and planning between all parties and their representatives. A thorough knowledge of laboratory compliance and rules and regulations is imperative as documentation and information that is provided and reviewed will more than likely change the pricing, value and terms of the deal.
Due diligence is required in any healthcare transaction and is performed so that both the buyer and seller fully understand the transaction. An effective and necessary tool regarding laboratory transactions is a due diligence checklist. The checklist will allow both sides to identify and address issues that may be neglected or overlooked. The categories that compromise a laboratory checklist should include, but are not limited to:
On October 6, 2020, the Unites States Attorney’s Office of the Western District of Louisiana announced that George M “Trey” Fluitt III of Monroe, Louisiana was indicted. The federal grand jury indicted the lab owner for paying bribes and kickbacks in violation of the Anti-Kickback Statute, resulting in improper Medicare billing of approximately $117 million. Fluitt was the owner and operator of Specialty Drug Testing, LLC and is alleged to have solicited paid kickbacks and bribes in return for patient DNA specimens and physicians’ orders for cancer genetic and pharmacogenetic testing. Medicare allegedly paid Specialty Drug Testing, LLC $28,726,299 as a result of the fraudulent claims. If convicted, the defendant faces up to five years in prison for each count of conspiracy to defraud a healthcare program. Fluitt also faces 10 years in prison for illegal kickbacks, a $250,00 fine, forfeiture and restitution.
When an overpayment is identified in Medicare Part A or B claims, providers can contest the overpayment amount by using the Medicare administrative appeals process. Because of the large difference between overpayment amount in a sample from an extrapolated amount, the OIG states that it is critical for the review process during an appeal to be fair and consistent. In the first and second levels of Medicare appeals (redetermination and reconsideration) extrapolated overpayments are reviewed by MAC (Medicare Administrative Contractors) and by QICs (Qualified Independent Contractors).
The OIG audit was to make sure that the MACs and the QICs reviewed the appealed extrapolated overpayments consistently and in compliance with CMS requirements.
What OIG found was that CMS did not always provide sufficient guidance and oversight to ensure that these reviews were performed in a consistent manner. The most significant inconsistency identified was the use of a type of simulation testing that was performed only by a subset of contractors. The test was associated with at least $42 million in extrapolated overpayments that were overturned in fiscal years 2017 and 2018.
On February 4, 2020, the Department of Justice announced a $1.5 million settlement with Southeastern Retina Associates, a 17 physician practice, with offices in Tennessee, Georgia and Virginia. The sole basis of the claim was the alleged misuse of the Modifier 25 billing code and charging for exams at higher levels than warranted. The claim was initiated by a whistleblower, who will receive $270,000 from the settlement.
Use and potential abuse of Modifier 25 is obviously not unique to retina surgeons. In fact, the modifier can be very beneficial to providers, since it allows for payment for those patient visits when the care provided exceeds the scope of the scheduled appointment. However, given the potential for abuse and the many watchful eyes of the government (the Southeastern Retina case was investigated by the U.S. Attorney’s Office, the HHS Office of Inspector General, the U.S. Office of Personnel Management, the FBI, and the Tennessee Attorney General’s Office) and wannabe whistleblowers, a periodic review of a provider’s billing practices is always a good idea.
Attorney Richard A. Merlino will present this live webinar for attendees interested in learning about strategies for proactively investigating a healthcare business. He will share information on predictive analytics and implementing compliance programs, as well as the top exposure areas where fraud is most likely to occur so that you can find the fraud before a whistleblower does.
Compliance programs should establish a culture that promotes prevention, detects and resolves healthcare fraud, per the OIG. Pursuant to the Whistleblower Protection Enhancement Act of 2012, the Department of Health and Human Services, Office of Inspector General, has established a Whistleblower Ombudsman to educate Department employees about prohibitions on retaliation for whistleblowing, as well as employees’ rights and remedies if anyone retaliates against them for making a protected disclosure.
CMS contractors such as Unified Program Integrity Contractors (UPICs) are tasked with ensuring that Medicare pays the right amount for covered services by legitimate providers. Specifically, a UPIC’s main goal is to identify cases of suspected fraud, waste and abuse, and additionally, to take immediate administrative action to protect federal program funds. Within its administrative action toolkit, apart from the common pre- or post-payment reviews and payment suspensions, UPICs have the ability to refer cases of potential fraud to law enforcement agencies.
The Office of Inspector General (OIG) announced the launch of a new tool on its website titled the “Fraud Risk Indicator”. The OIG has stated that the purpose for the tool is to provide guidance on how it has evaluated risk in settling False Claims Act (FCA) cases and to publicize information about where FCA defendants fall on the OIG’s risk spectrum. This tool can benefit patients, healthcare industry professionals and other individuals who may find this information relevant. This tool will also benefit the public with information about providers charged under the FCA that are at high risk for committing healthcare fraud. The Indicator shows the Risk Spectrum from Highest Risk to Lower Risk.
In giving consideration to whether healthcare regulations apply to a proposed course of conduct it’s absolutely vital for a pharmacy to know its payor! This is especially so in the context of patient marketing and the various regulatory prohibitions on paying for healthcare referrals. Unfortunately, some pharmacy owners remain a bit mixed up about who the ultimate payor is for the medications they dispense, and, depending on that pharmacy’s billing operations, such mistakes can have devastating consequences.
A large part of this confusion might be attributed to the fact that in most instances, a pharmacy is not billing the ultimate payor directly (unlike a DMEPOS provider that may be directly submitting claims to Medicare Part B), but rather, the pharmacy is billing an intermediary entity called a Pharmacy Benefit Manager (“PBM”), which is usually a commercially run entity (non-government owned) that manages and adjudicates claims on behalf of health insurance plans that cover pharmacy benefits.
A recent whistleblower action (by UnitedHealthcare Medical Director, Tina Groat) against Boston Heart (laboratory) was brought under the federal False Claims Act and deals with medical necessity issues. As part of the analysis, the Court reviewed whether a laboratory [or supplier like DME] must determine the medical necessity of the ordering physician. Boston Heart contended that a doctor, not a laboratory, determines the medical necessity of a test. Boston Heart argued that when a laboratory bills Medicare for testing ordered by a physician, it must only maintain documentation it receives from the ordering physician and ensure that the information that it submitted with the claim accurately reflects the information it received from the ordering physician. It noted that the CMS-1500 form certification does not require that the billing lab to make the medical necessity determination. The lab certifies that the services are medically necessary by relying on the clinical determination of the treating physician.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.