On November 8, 2021, The Department of Health & Human Services (HHS), Office of Inspector General (OIG) released a revised and renamed Provider Self-Disclosure Protocol (SDP), now known as the “Health Care Fraud Self Disclosure “protocol. The SDP was created in 1998, and the protocol can be used to voluntarily identify, disclose and resolve instances of potential fraud involving federal healthcare programs. As described on the OIG website, “Self-disclosures give persons the opportunity to avoid the costs and disruptions associated with a Government-directed investigation and civil or administrative litigation.”Continue reading
By: Karen Davila
Yet again, the fraud enforcement arm of the DOJ strikes out against fraud in the pharmacy industry. Two new cases shed continuing light on the ongoing fraud.
Announced last week by the DOJ, the owner/operator of five pharmacies in New York pled guilty to charges stemming from a scheme to defraud Medicare and Medicaid by billing for prescription drugs that were not dispensed, not prescribed, not medically necessary or dispensed when the pharmacy had no authority to dispense the prescription drugs. This blatant disregard for the law was magnified when the owner/operator used the ill-gotten gains of her scheme to purchase luxury items like cars and jewelry. Nothing screams “come and get me” like openly flaunting the money taken from the government.Continue reading
By: Jacqueline Bain
On November 3, 2020, Gilead Sciences Inc. filed suite in the Southern District of Florida Federal Court seeking damages from and injunctions against 58 defendants in South Florida for their part in an alleged scheme to defraud Gilead for millions of dollars. The defendants are comprised of medical clinics, laboratories, pharmacies and their owners, officers and employees.
Gilead is a pharmaceutical company that develops and manufactures drugs for the prevention and treatment of HIV, AIDS, hepatitis B and hepatitis C. Gilead has created a medication assistance program that provides eligible uninsured persons with free medication to help protect them from becoming infected with HIV. Gilead alleges that the defendants are exploiting the program’s charitable purpose for their own financial gain, endangering patients in the process.
The alleged scheme is complex and involves a lot of people participating in a wide-spread conspiracy, yet is exactly the type of convoluted scheme that regulators and insurance companies target. If the allegations are true, nearly 60 fraudulent operators will have to find another line of business. The OIG is likely to be following this very closely to determine if federal charges should follow.Continue reading
“The Lab Guy” Dean Viskovich joins the Florida Healthcare Law Firm with expertise in the laboratory legal space including lab compliance programs, regulation and operations.Continue reading
By: Karina Gonzalez
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.Continue reading
Medicare claims are processed by organizations (i.e. Medicare Administrative Contractors (“MACs”)) that contract with the Centers for Medicare & Medicaid Services (“CMS”) to act as liaisons between the Medicare program and providers and suppliers. As CMS continues to evolve its Medicare audit enforcement strategies to reduce fraud and abuse in the system, post payment reviews utilizing statistical sampling still remain as one of its key methods.Continue reading
By: Karina Gonzalez
The US Department of Health and Human Services, Office of Inspector General (OIG) reports that as part of its 2017 Work Plan it will be reviewing Medicare Part B payments for telehealth services. These services support rural access to care and Medicare pays telehealth services provided through live, interactive videoconferencing between a Medicare beneficiary located at an origination site and a healthcare provider located at a distant site.
The OIG is reviewing Medicare claims that have been paid for telehealth services that are not eligible for payment because the beneficiary was not at an originating site when the consultation occurred. A beneficiary’s home or office is not an originating site, an eligible originating site must be a practitioner’s office or a specified medical facility.Continue reading
By: Jacqueline Bain
I had a law school professor who repeatedly referred to his class as “Doom at Noon.” The topic was dry, the cases were boring and, if not for the professor himself, the class would have been unbearable. I think of that, all these years later, every time I have to counsel a client on a topic that makes his or her eyes glaze over, like healthcare compliance.
Compliance means that you’re operating within the bounds of law. Sure, it sounds boring, but it’s a giant undertaking for any business, and especially for one so regulated as healthcare. Over the last three decades, the Department of Health and Human Services’ Office of the Inspector General has urged the private healthcare community in to take steps to combat fraudulent conduct and prevent the submission of erroneous claims.Continue reading
By: Jacqueline Bain
In the healthcare business, giving a patient a break on a health insurance copay is often viewed as suspicious. The reasoning for the suspicion is that the financial incentive may give one provider a competitive advantage over another, or persuade a patient to seek services that might not be medically necessary. Moreover, any person who interferes with a patient’s obligations under his/her health insurance contract may be viewed as tortuously interfering with that contract. However, in an advisory opinion issued on December 28, 2016, the OIG opined that, in certain instances, a non-profit, tax-exempt, charitable organization could provide financial assistance with an individual’s co-payment, health insurance premiums and insurance deductibles when a patient exhibits a financial need.
The party requesting the advisory opinion was a non-profit, tax-exempt, charitable organization that did not provide any healthcare services and served one specified disease. The non-profit, tax-exempt, charitable organization is governed by an independent board of directors with no direct or indirect link to any donor. Donors to the non-profit, tax-exempt, charitable organization may be referral sources or persons in a position to financially gain from increased usage of their services, but may not earmark funds and or have any control over where their donation is directed.Continue reading
By: Dave Davidson
In 1986 President Ronald Reagan signed the Emergency Medical Treatment and Active Labor Act (EMTALA) into law. Since then, the application of the law has been expanded and refined. It was one of the first laws giving the government the authority to dictate certain operations of a hospital. While other laws and regulations such as the Anti-Kickback Statute and the Stark Law have become more of a focus for health care providers, EMTALA remains an area of active enforcement. All providers with hospital privileges should therefore be aware of its application.
The policy behind the law is fairly straightforward. Hospitals with emergency departments should not be able to turn away patients needing care because of their inability to pay (no more “wallet biopsies” as part of triage). Likewise, hospitals should not be able to “dump” patients on other facilities for reasons other than for advanced care.
The requirements of the law are also very basic. If a patient comes to an emergency department and requests an examination or treatment for a medical condition, the hospital must provide an appropriate medical screening exam, within its capability, to determine whether or not the patient has an emergency medical condition. The screening provided goes beyond simple triage, and must be performed by a clinical provider such as a physician, nurse practitioner, or physician’s assistant.Continue reading