AMARILLO, TX – The Office of Inspector General (OIG) is an agency under the Department of Health and Human Services (“DHHS”). It was established in 1976. The OIG is the largest civilian inspector general’s office in the federal government. It is responsible for $2.4 trillion of programs and has approximately 1650 auditors, investigators and evaluators.
The OIG works with DHHS staff, other executive branch agencies, Congress, states and the private sector. The OIG’s work includes:
- data analytics and modeling;
- criminal, civil and administrative investigations;
- compliance guidance and education;
- technical expertise on program integrity issues; and
- cyber security oversight.
The offices under the OIG are:
- Office of Audit Services (“OAS”) – In FY 2021, the OIG conducted 162 audits. It uses data analytics and risk assessments to identify emerging issues and target high-risk areas.
- Office of Evaluation and Inspections (“OEI”) – The OIG conducts national evaluations to provide to DHHS, Congress and the public. In FY 2021, the OIG conducted 46 evaluations.
- Office of Investigations (“OI”) – The OI conducts criminal, civil and administrative fraud investigations. In doing so, it coordinates with the Department of Justice (“DOJ”) and other federal, state and local law enforcement agencies. The OI also coordinates with OAS and OEI.
- Office of Counsel to the Inspector General (“OCIG”) – This is an in-house group of attorneys who provide legal advice to the OIG and compliance guidance to health care providers. The OCIG also works with the DOJ on False Claims Act (“FCA”) cases.
- Mission Support and Infrastructure (“MSI”) – MSI is composed of the Immediate Office of the Inspector General and the Office of Management and Policy. MSI is responsible for coordinating OIG activities and providing mission support.
The OIG website contains resources designed to educate providers on how to avoid fraud. The resources can be general in nature. But they are often specific to different types of providers: hospitals, physicians, DME suppliers, labs, pharmacies, etc. These resources include:
- Roadmap for New Physicians – The OIG has created educational materials to teach physicians about federal laws designed to prevent fraud.
- Corporate Integrity Agreements (“CIAs”) – When a provider settles a civil fraud investigation with the DOJ, the provider is normally required to sign a CIA with the OIG. In other words, at the time of settlement, the provider (i) signs a Settlement Agreement with the DOJ and (ii) signs a CIA with the OIG. A CIA normally has a five year term. The CIA requires the provider to implement a number of protocols designed to help the provider avoid fraudulent actions in the future. For example, the CIA will likely require the provider to (i) adopt a formal compliance program; (ii) train existing and future employees on their compliance obligations; and (iii) contract with an Independent Review Organization (“IRO”) to audit certain activities each year. If the provider successfully fulfills its obligations under the CIA, the OIG will not seek exclusion. On the other hand, if the provider breaches its obligations under the CIA, the the provider will likely face exclusion.
- Toolkits – The OIG has created toolkits to aid providers in being compliant.
- Advisory Opinions – If two or more parties wish to enter into a business arrangement, but they are concerned that the arrangement might implicate the federal anti-kickback statute (“AKS”), the parties can ask the OIG for a written Advisory Opinion (“AO”). When the OIG publishes the AO it can be found on the OIG website. When publishing AOs, the OIG de-identifies the parties. The AO will say one of three things: (i) the arrangement will likely implicate the AKS; (ii) the arrangement will not likely implicate the AKS; or (iii) while the arrangement may implicate the AKS, the benefits to the Medicare program outweigh the potential kickback risks and, therefore, the OIG will exercise its discretion not to bring an enforcement action. Legally, AOs are binding only on the parties asking for the AO. However, from a practical standpoint, AOs provide guidance to all providers. Lastly, while most AOs involve future arrangements, parties to an existing arrangement can also ask for an AO.
- Voluntary Self-Disclosure – If a provider determines that it has engaged in fraud, it can request to be accepted into the OIG’s self-disclosure protocol (“SDP”). If accepted, the provider will, in cooperation with an OIG attorney, conduct a self-investigation and determine the monetary damages incurred by the federal health care program (“FHCP”). Once the OIG and provider agree on the facts and the dollar amount, then the OIG will accept a multiple (1x, 1.5x, 2x) of the damages. Such a monetary settlement is much less than potential liability under the FCA. A successful self-disclosure will cut off future whistleblower lawsuits (based on the facts made the subject of the self-disclosure) and will likely result in the provider not having to execute a CIA.
- RAT-STATS – Providers can download a free statistical software package to assist in claims review.
- Open Letters – The OIG occasionally issues letter to providers alerting them to OIG policies and inviting them to engage in anti-fraud initiatives.
- Compliance Guidance – The OIG has published voluntary compliance program guidance documents directed at various providers.
- Safe Harbors – The AKS is broadly written. Understandably, providers may not be able to determine if an arrangement implicates the AKS. Recognizing this challenge, the OIG has issued a number of “safe harbors.” If an arrangement fully complies with a safe harbor, then as matter of law the arrangement does not violate the AKS. If an arrangement does not fully comply with a safe harbor, it does not mean that the arrangement violates the AKS. Rather, it means that the arrangement needs to be closely scrutinized in light of the wording of the AKS, court decisions, and other published guidance.
- Special Fraud Alerts, Bulletins and Other Guidance – The OIG publishes a number of fraud alerts, advisory bulletins and other guidance designed to educate providers on activities/arrangements that are potentially problematic. Some alerts/bulletins are general in nature while others are geared to specific provider groups.
AAHOMECARE’S EDUCATIONAL WEBINAR
Sales Tax and Products Billed Through Insurance: Avoid the Landmines
Presented by: Steven D. Moore, Esq., Jackson Walker & Jeffrey S. Baird, Esq., Brown & Fortunato
Tuesday, October 11, 2022
1:30-2:30 p.m. CENTRAL TIME
In the past, DME suppliers primarily billed traditional Medicare and Medicaid. This is changing. With the expansion of Medicare and Medicaid managed care, suppliers are now increasingly billing commercial insurers. Unfortunately, a number of suppliers have the mistaken impression that they do not have to remit sales tax. Failure to remit sales tax, even when the supplier is unable to collect the sales tax from the patient or insurer, can have serious consequences for the supplier. Each state has the authority to determine its sales tax requirements. While there are similarities across states, there are also differences. For example, a particular product may be subject to sales tax in State A, but not in State B. This program will present an overview of state sales tax laws and will then focus on the laws of five of the larger states. The program will discuss the sources that DME suppliers can go to in order to determine if a product is subject to sales tax in a particular state. The program will also discuss the steps that a DME supplier can take if it and a state enforcement agency disagree on whether a product is subject to sales tax.
Register for Sales Tax and Products Billed Through Insurance: Avoid the Landmines on Tuesday, October 11, 2022, 1:30-2:30 p.m. CT, with Steven D. Moore, Esq., of Jackson Walker and Jeffrey S. Baird, Esq., of Brown & Fortunato.
Jeffrey S. Baird, JD, is chairman of the Health Care Group at Brown & Fortunato, a law firm with a national health care practice based in Texas. He represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Baird is Board Certified in Health Law by the Texas Board of Legal Specialization and can be reached at (806) 345-6320 or firstname.lastname@example.org.