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Healthcare Fraud Scheme Indictment Starts the New Year

January 14th, 2022 by

The U.S. Attorney arrested 13 people in a $100 Million healthcare fraud scheme in NY and NJ involving automobile insurance claims.  Some of the facts alleged include—

  • Bribed 911 operators and hospital employees for confidential information of insured drivers
  • Unnecessary and painful medical procedures
  • A non-physician owning medical clinics
  • Paying hundreds of thousand of dollars to “runners” who used the money to bribe people

Healthcare businesses that largely serve people injured in motor vehicle accidents remain a top tier focus for law enforcement and special investigative units (SIUs) of insurers.  But so do many other providers in the healthcare sector, such as pharmacies, durable medical equipment (DME) providers, addiction treatment providers and labs.  Payer and governmental presumption is often that financial motives are driving clinical behavior, NOT documented medical necessity.  Hence the need for active compliance plans and policies and procedures that don’t sit on a shelf, but rather are woven into daily business and clinical operations.  Nothing less than the right contracts, the right compliance plan and the right business culture will establish and maintain a sustainable healthcare business!

OIG Revises Self-Disclosure Protocol

December 2nd, 2021 by

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.” read more

Florida Medical Device Company Settles $16 Million Case

November 10th, 2021 by

Enforcement against medical device companies is not new and yet, these companies continue to engage in schemes that land them in hot water.  Frequently the same schemes are repeated over and over- some form of payment by the device company to a physician who selects/recommends the device to patients.  In some cases, the payment is in the form of an honorarium for speaking engagements.  In others, the payment is an all-expense paid travel to attend device company-sponsored “CME” in exotic locations or consulting fees for assisting in the evaluation and design of the device.

Announced yesterday by the U.S. Department of Justice (DOJ), is the settlement of allegations against Florida-based Arthrex Inc., a medical device company that specializes in orthopedic products.  Under the settlement agreement, Arthrex will pay $16 million for allegedly paying kickbacks to an orthopedic surgeon (Dr. Peter Millett) in Colorado.  The “payment” in this case was structured as royalty payments purportedly to compensate the orthopedic surgeon for his “contributions” to the development of two of Arthrex’s products when in fact the “payment” was intended to induce the surgeon’s recommendation/selection of the Arthrex products.  By offering the payments to the surgeon with the intent to induce purchase of Arthrex’ products which were then billed to Medicare, Arthrex violated the Anti-Kickback Statute (AKS) as well as the False Claims Act. read more

Compounding Pharmacies Remain at the Tip of the Enforcement Spear

November 8th, 2021 by

Compounding pharmacies are subjected to special licensing and permitting rules because of the heightened risk of the very nature of what they do- customizing a prescription by combining, mixing or altering ingredients to create a sterile or non-sterile medication for a given patient.  Pharmacies may only compound drugs where a commercially available drug/dose/formulation is not available.  Because of the heightened risk coupled with the high cost of compounded drugs and the increased prescribing of these expensive drugs, compounding pharmacies continue to be at the tip of the enforcement spear and a target for investigations.   This and the fact that the number of compounding pharmacies is only a fraction of the number of licensed pharmacies in the U.S., contributes to the increasing visibility when the U.S. Department of Justice prosecutes violators.

Growth of Compounding

From 2006 to 2015, the U.S. experienced a sevenfold increase in the prescribing of compounded drugs.  Recently, the compounding pharmacies market was valued at more than $9 billion and is projected to grow by another $5 billion over the next 30 years. read more

Routine Waiver of Patient Financial Responsibility – A Wolf in Sheep’s Clothing

May 19th, 2021 by

By: Michael Silverman

While not a ‘classic’ kickback – such as the scenario of a practitioner receiving remuneration in exchange for a prescription or referral of healthcare business – the routine waiver of patient financial responsibly by a healthcare provider ALSO constitutes healthcare fraud, even for commercially insured patients!

Unfortunately, such a serious violation does not readily come to mind for many of those operating in the healthcare space, but its relatively straightforward once you think about it. In essence, a financial incentive is being provided to the patient to utilize the services of a certain healthcare provider by virtue of that individual not being subjected to out-of-pocket expense they normally would be subjected to if they were to utilize another similarly situated provider. read more

Permissible Payments For Referrals Under The Federal Anti Kickback Statute

April 28th, 2021 by

anti kickbackBy: Karen Davila

The term “payment for referral” strikes fear in the hearts of health care providers throughout the country because of the significant prohibitions under the federal Anti-Kickback Statute (AKS).  And, Florida’s Patient Brokering Act (PBA) casts an even bigger shadow over arrangements involving payment in exchange for referrals.  There are other statutory restrictions as well, which may apply depending upon the services for which a referral is being made.  Those include but are not limited to statutes prohibiting physician fee-splitting and the federal Eliminating Kickbacks in Recovery Act (EKRA) (applicable to referrals to recovery homes, clinical treatment facilities, or laboratories in an effort to stave off growing opioid-related fraud), and the potential collateral damage of a false claim under the federal False Claims Act (FCA) if any of the above statutes are violated.

So, is there any scenario where a payment may be made by a health care provider in exchange for referrals?  The answer is yes- there is a safe harbor under the AKS (42 U.S. C. §1320a-7b(b)) specifically for such arrangements.  This safe harbor is not commonly used and likely means revision to existing arrangements to come into compliance with its specific requirements.  But it may be worth considering if the referral (and payment for that referral) is not otherwise prohibited as noted above. read more

A DME Fraud of Epic Proportions

February 8th, 2021 by

dme telemedicine fraudBy: Michael Silverman

Almost two years after “Operation Brace Yourself” regarding purported telemedicine and orthotic bracing fraud made national headlines, on February 4, 2021 the Department of Justice Announced that a major player in that fraud – Florida businesswoman Kelly Wolfe – recently pled guilty to criminal health care and tax fraud charges.

Operation Brace Yourself was a 2019 crackdown on the illegal use of telemarketing and telemedicine to generate fraudulent claims for DME orders, whose reach spanned continents and ultimate implications defrauded taxpayers out of billions of dollars.

According to the Department of Justice Press Release and Settlement Agreement, Mr. Wolfe was seemingly a significant mastermind in establishing hundreds of DME companies that went on to defraud US taxpayers and Medicare beneficiaries.

Here are some highlights of the recently signed Settlement Agreement between the United States DOJ, Kelly Wolfe and her company Regency, Inc. read more

Healthcare Marketing: Measure Twice, Cut Once

December 3rd, 2020 by

fhlf healthcare marketingBy: Jeff Cohen

Wanna know how often we’re asked whether the laws re healthcare marketing are really enforced?  How often we hear “Everyone is doing it.”  “Surely they [regulators] understand that every healthcare business has to market its services and item,” we’re told.  And when we start to educate people re the state and federal laws that pertain to marketing healthcare items and services (INCLUDING those for which payment isn’t made by a state or federal healthcare program), their impatience and intolerance is palpable.

Take a look at the latest report from the Department of Justice guilty plea from someone who marketed the services of a genetic testing lab.  He admitted being guilty of receiving over $300K in kickback money (presumably in the form of marketing fees) and now faces (1) a $250K fine, (2) returning all the money he received, and (3) five years in prison!

Marketing any healthcare service or item is at the tip of the sword in terms of regulatory investigation and enforcement.  It’s that simple.  And so when your lawyers drag you through laws like the Anti-Kickback Statute, the Florida Patient Brokering Act, the federal health insurance fraud law, the bona fide employee exception, the personal services arrangement and management contract safe harbor and EKRA, thank them!  And expect nothing less.  If you do ANYTHING at all in the neighborhood of marketing a healthcare item or services, the first place to start is:  meet with a very experienced healthcare lawyer who is not learning on your dime.  And have them take a couple hours to educate you about the laws, the options and the risks of each one.  And once you’ve done that, ask them what more you can do to reduce your risk, for instance— read more

When Does a Gift Become a Kickback?

October 30th, 2020 by

gift or kickbackBy: Zach Simpson

Since the beginning of the COVID pandemic many healthcare businesses are exploring various ways to increase their referrals, and although exchanging fees and gifts in return for referrals may sound like an easy way to obtain additional business, there are state and federal laws that strictly prohibit such activities that are discussed in greater detail below.

Two of the most important laws that all physical therapists should be aware of are the Anti-Kickback Statute and the Stark Law which are used to ensure that medical decisions are not made based on financial incentives. However, each of the laws do have distinctions that you need to be aware of. read more

Lab Owner Indictment Update

October 7th, 2020 by

fhlf laboratory complianceBy: Dean Viskovich

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.

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