Articles Posted in Medicare Fraud

1330873_courthouseThis litigation involves claims of unfair competition and tortious interference under nine different states’ laws, where the claims are based, in part, upon alleged violations of the federal Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b), and Stark law (“Stark”), 42 U.S.C. § 1395nn(a).  Our Georgia business and healthcare law firm follows legal developments in the world of healthcare.

This particular dispute is between Ameritox Ltd and Millenium Laboratories, Inc.   These laboratories are competitors in the drug-screening/testing marketplace. Each sells to physician practices and other healthcare providers products and services that facilitate analysis of patient drug use, including point-of-care (POCT) cups. POCT cups are used by physician practices to collect and store urine samples. Additionally, POCT cups contain chemically activated strips that indicate the presence of particular drugs in the patient’s system. POCT cups thereby facilitate “qualitative testing,” informative of patients’ drug use. Such information is very limited, however; it does not, for example, reveal the precise quantity of a drug in the patient’s system. To obtain more meaningful information about the patient, a doctor must send the POCT cup to a clinical laboratory, for “confirmatory testing.” These two laboratories compete for that business.

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hammer-to-fall-673264-mPhysicians and other healthcare providers and businesses who seek to stay in the center of the court and avoid fraud allegations often inquire of our Georgia business and healthcare law firm about the applicability of STARK (civil statute) or the Federal Anti-kickback (criminal) statute to particular circumstances or transactions. While those laws have great importance and severe penalties for violations, another federal law often warrants review to ensure business is conducted in a legally compliant manner. Many physicians and healthcare businesses have not heard of the “Civil Monetary Penalties” law (CMP), found at 42 U.S.C. § 1320a-7a.

Under the CMP law, the United States Office of Inspector General (OIG) may impose civil monetary penalties upon persons, organizations or entities who knowingly present (or cause to be presented) to a state or federal government certain types of false claims. Such penalties can be severe, ranging from $2,000 to $50,000. Further, the law gives the OIG the ability to treble damages.

So, what triggers CMP?

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medical-doctor-1314902-mRecent articles by ProPublica and NPR spotlight the absence of reporting requirements by pharmaceutical companies of their payments to nurse practitioners and physician assistants under the Affordable Care Act’s (ACA) Physician Payment Sunshine Act. The two web articles reference a case in which a Connecticut nurse practitioner pled guilty to accepting $83 million in kickbacks “from a drug company in exchange for prescribing its high-priced drug to treat cancer pain. In some cases, she delivered promotional talks attended only by herself and a company sales representative.” Because the law does not require reporting of industry payments to nurse practitioners such as this Connecticut provider, if not for the lawsuit, the public might have remained unaware of such payments to her and others like her.

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Large financial recoveries are often seen as the principal motivation for the government’s unrelenting efforts to combat healthcare fraud. Perhaps a more important objective of the government’s efforts to combat healthcare fraud, however, is protecting patient safety. Chronic overutilization of healthcare, driven by a fee-for-service system with patient cost covered by a third-party payer (public or private), is not just a financial problem, it is a public health problem. The DOJ’s announcement on May 22, 2015, of a guilty plea by a Detroit Neurosurgeon is a strong example.

Atlanta and Augusta Business and Healthcare Lawyers

Dr. Aria O. Sabit, M.D., 39, operated the Michigan Brain and Spine Physicians Group, with multiple locations in Michigan. Dr. Sabit has plead guilty to four counts of healthcare fraud involving his alleged performance of medically unnecessary, invasive spinal surgeries and implanting expensive medical devices that were not medically necessary. According to the indictment, Dr. Sabit persuaded some patients to undergo spinal infusion surgeries, which he did not render, and then billed government programs for the fraudulent services. Additionally, Dr. Sabit admitted that while operating on certain patients, he dictated false operative reports that he had performed spinal infusion with particular instrumentation, which had not been done. The invasive surgeries caused serious bodily injury to the patients, according to the indictment.

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us-capitol-building-2-431642-mBy: Lee H. Little

Health Care providers evaluating billing compliance for psychotherapy services should take caution from a recent multi-million dollar settlement under the federal False Claims Act involving allegedly unnecessary intensive outpatient psychotherapy (IOP) services.

Georgia Healthcare Law Firm

According to the Department of Justice’s (DOJ) press release, the government’s allegations were that billing by these providers was improper because the patient conditions did not qualify for IOP; patient treatments were not provided pursuant to an individualized treatment plan designed to help patients address specific mental health needs and reach achievable goals; patient progress was not adequately tracked or documented; patients received an inappropriate level of treatment; and/or the therapy provided was primarily recreational or diversional in nature, and not therapeutic.

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As Medicare fraud schemes continue to bilk federal taxpayers of billions of dollars, federal law enforcement continues to push diligently to identify and prosecute Medicare fraud. Because of the importance to federal law enforcement of ferreting out healthcare fraud schemes, it is critical for all healthcare providers and healthcare businesses to follow the law to the letter and keep their business practices in the center of the court.

Georgia Healthcare Fraud Defense Law Firm

A key focus for the government is whether tests and procedures are actually medically necessary and properly documented. A recent example is the case of Dr. Salomon E. Melgen. On April 14, 2015, the Department of Justice announced the indictment of Dr. Melgen for alleged Medicare fraud in connection with eye centers owned and operated by him. Dr. Melgen, 60, is a Florida ophthalmologist and retina specialist. He owned the Vitreo-Retinal Consultants Eye Center and the Melgen Retina Eye Center, which together had four offices in south Florida. The eye centers treated 100 or more patients a day, many of whom were Medicare beneficiaries.

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united-states-capital-516992-m.jpgEarlier this month, the Centers for Medicare and Medicaid Services (CMS) announced implementation of a Final Rule intended to increase oversight of Medicare providers and enable recoveries from those health care providers that commit fraud and violate Medicare rules. According to the press release, Marilyn Tavenner, the CMS Administrator, stated that the new rules “are common-sense safeguards to preserve Medicare for generations to come” and that “[t]he Administration is committed to using all appropriate tools as part of its comprehensive program integrity strategy shaped by the Affordable Care Act [ACA].”

Georgia Medicare Fraud Law Firm

Our Atlanta and Augusta, Georgia health care law firm has reviewed the Final Rule. The Final Rule’s new provisions are intended to preclude doctors and other health care providers with unpaid Medicare debt from re-entering the Medicare program, remove health care providers who engage in abusive Medicare billing, and authorize other provisions that will save more than $327 million annually. The Final Rule makes certain changes to the provider enrollment provisions of 42 CFR part 424, subpart P.

CMS has removed about 25,000 health care providers from the Medicare program. The new rules are designed to “stop bad actors from coming back in as we continue to protect our patients,” according to Ms. Tavenner. Under the ACA, CMS has increased ability to fight Medicare fraud, waste and abuse. CMS believes that removing providers from Medicare has a substantial positive impact on savings, contending that such removals have prevented $81 million in payments from being made.
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woman-in-hospital-1051476-m.jpgThe Department of Justice (DOJ) announced on October 22, 2014 a resolution of claims that DaVita Healthcare Partners, Inc., a provider of dialysis services, engaged in a referral and kickback scheme that violated the False Claims Act (FCA). The DOJ announced that DaVita has agreed to pay $350 million to settle the government’s case. The Government’s case was not proven and was only alleged. Liability was not determined prior to the settlement and DaVita has not been shown to have engaged in wrong doing. Our Atlanta and Augusta, Georgia business and health care law firm represents health care providers and businesses and helps them avoid legal pitfalls.
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whistle-182576-m.jpgThe vast majority of physicians and other health care providers endeavor to provide services and bill for them in an ethical, legal manner. Trust is at the core of the federal government’s provider reimbursement scheme under Medicare and other federal health programs. The federal government relies upon health care providers submitting accurate and truthful claims. The fact that some health care providers have exploited federal health programs for illegal economic gain has resulted in laws intended to combat fraud and abuse, improve patient care and protect tax payer money. Currently, there is a strong push in federal law enforcement to aggressively enforce federal fraud and abuse laws.1

The Federal False Claims Act (FCA)2 makes it illegal for health care providers to submit claims for payment to Medicare that the provider knows, or should know, are false or fraudulent. The FCA contains a whistleblower provision that authorizes a private citizen or “relator” to file a lawsuit on behalf of the federal government, and entitles relators to a percentage of any recovery. FCA whistleblower cases often assert violations of other federal fraud and abuse laws, such as the Anti-Kickback Statute (AKS),3 the Physician Self-Referral Law (Stark Law),4 the Exclusion Authorities,5 and the Civil Monetary Penalties Law (CMPL).6

For relators, “blowing the whistle” becomes more than an abstract notion when it comes time to “plead,” or state, the claim in court. Assuming a claim has legal merit, getting it right in court is what determines success or failure. Following the law in reporting alleged wrongdoing is essential, including procedural law dictating how to properly plead a case. Rule 9(b) of the Federal Rules of Civil Procedure requires that “[t]he whistle must be blown not only loudly, but with Rule 9(b) particularity in the Complaint before the courts will listen.”7 The concept of “particularity” is important to a federal whistleblower’s opportunity for success. This means is that a whistleblower complaint must state “facts as to time, place, and substance” of the alleged wrongdoing, and that “an actual false claim for payment [was] made to the Government.”8
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law-education-series-3-68918-m.jpgClinical laboratory payments to physicians in excess of the fair market value of services provided or that correlate to the volume or value of referrals can constitute health care fraud and trigger very serious civil and criminal penalties. The Department of Health and Human Services’ Office of Inspector General (OIG) recently issued a Special Fraud Alert (the “Alert”) addressing lab compensation to referring doctors and medical practices for blood specimen collection, processing and packaging, and for submitting patient data to a registry or database. Our Georgia health care law firm endeavors to follow updates in health care laws and regulations that impact providers, particularly Stark law and the federal Anti-Kickback Statute (AKS). This OIG Alert warrants caution and careful evaluation of any applicable financial arrangements by affected physicians and medical practices to ensure compliance with federal law.

Labs and physicians: BEWARE of Stark Law and the Anti-Kickback Statute
At the heart of Stark Law and the AKS is the notion that (unlike most other industries) health care business referrals may, under some circumstances, be a bad thing. Kickbacks that corrupt medical judgment about the medical necessity of services, result in the overutilization of medical products and services, increase the cost of federal programs, or that cause unfair competition, are of great interest to the Federal Government and are the intended targets of Stark Law and the AKS.

The AKS, unlike Stark, is a criminal statute, a violation of which requires evidence of criminal intent. However, the OIG may find evidence of such intent even by mere characteristics of a particular financial arrangement, including legal structure, the absence of safeguards, and, of course, actual conduct of the parties regarding the arrangement.
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