DME Industry 2021 Year End Review & Looking Into 2022

Many DME providers have had tremendous hurdles to overcome this year, from the implementation of a new round of Medicare’s Competitive Bidding Program through continued impacts of COVID-19. Mergers and acquisitions are through the roof as a result, as are continued compliance concerns that plague the industry.

Let’s dive into some of the major DME related matters & issues that have come across my desk this year, and what to be on the lookout for in the next.

Competitive Bidding Impacts

After much uncertainty about what DME products would actually be included upon its implementation, Round 2021 of Medicare’s Competitive Bidding Program (“CBP”) kicked off at the beginning of this year.

With off-the-shelf knee and lumbar braces (HCPCS Code OR03) included in Round 2021 of the CBP – and thus ability to supply such devices to beneficiaries in competitive bid areas restricted to bid-winners – non bid-winning DME providers have been scrambling to find new revenue streams to fill the void. Unfortunately, many are doing so in a non-compliant manner.Continue reading

Telemedicine Pharmacy Fraud Trial Ends in Convictions

Telemedicine pharmacy arrangements continue to be of significant interest to fraud enforcement.  A 2018 case in which four individuals and seven companies were indicted ended in a month-long jury trial of one of the individuals, a Florida pharmacy owner.  The federal jury trial in the billion-dollar telehealth pharmacy fraud scheme resulted in conviction on 22 counts of mail fraud, conspiracy to commit health care fraud and introduction of misbranded drugs into interstate commerce.  Sentencing in the case is set for May of 2022.  Other co-conspirators entered plea agreements along the way, pleading guilty to various charges including felony conspiracy to commit health care fraud, felony misbranding, conspiracy to commit wire fraud, and fraudulent telemarketing of dietary supplements, skin creams and testosterone.  Many of these are still awaiting sentencing, also expected to be scheduled sometime in 2022.

THE SCHEME

The scheme involved several individuals, compounding pharmacies and telemarketers engaged in a conspiracy to commit health care fraud, mail fraud and introducing misbranded drugs into interstate commerce.  Peter Bolos, along with two other co-conspirators, owned and operated Synergy Pharmacy in Palm Harbor, Florida.  Working with HealthRight, a telemarketer, the co-conspirators generated prescriptions for drugs such as pain creams, scar creams, and vitamins.  Using the HealthRight telemarketing platform, they would call consumers and deceive them into providing their personal insurance information and accept the drugs. HealthRight then communicated the prescription requests to physicians who authorized the prescriptions without ever interacting with the patients, and paid those physicians for issuance of the prescriptions. Through this scheme, the co-conspirators were able to solicitate insurance coverage information from consumers across the county for prescription pain creams, fraudulently obtain prescriptions, mark up the prices of the drugs and bill private insurance carriers.Continue reading

Compounding Pharmacies Remain at the Tip of the Enforcement Spear

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.Continue reading

Health Care Fraud Enforcement Continues to Rock Pharmacy Industry

pharmacy fraud

pharmacy fraudBy: 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

Health Care Fraud Enforcement Got You Worried?

healthcare fraud in 2020

healthcare fraud in 2020By: Karen Davila

Healthcare fraud continues to be a significant priority for the U.S. Department of Justice.  On February 24, 2021, the DOJ’s Criminal Division Fraud Section published its annual “Fraud Section Year in Review 2020.”  While the Fraud Section has three separate enforcement units, the Health Care Fraud (HCF) Unit is responsible for all enforcement activities in the health care industry.  The Unit’s focus is to protect against fraud and abuse in federal health care programs and recoup illicit gains.

During 2020, the HCF Unit operated 15 strike forces in 24 federal judicial districts throughout the U.S.  The efforts of these strike forces led to charges against 167 individuals alleging $3.77 billion in fraudulent charges for health care paid for by federal and state programs.  This should cause any health care provider to stand up and take notice.  And enforcement in the health care industry is not likely to go away soon with so many schemes ripe for the government’s picking and generating recoupment on behalf of the federal health care programs.

Here are couple of the latest schemes that have landed pharmacies, pharmacists and other health care professionals squarely in the crosshairs of federal enforcement:

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What to Do When The Government Comes Knocking

business meeting between healthcare professionals and goverment

business meeting between healthcare professionals and govermentBy: Karen Davila

You do everything right.  You’re careful to dot your i’s and cross your t’s.  Compliance is hard-wired because you’re in an industry that’s highly regulated and you’ve built into your operations a series of compliance checks and balances.  However, even with strong controls in place, compliance efforts sometimes fall short– and whether you’re a physician group, a pharmacy, a durable medical equipment company, a home health agency, or any other health care provider, someday you might find yourself face-to-face with law enforcement officials or regulatory enforcement authorities.  What do you do?  How do you assure the most successful outcome with minimal business disruption?

Compliance is the foundation to mitigating the risks inherent in any health care operation.  Compliance can reduce the likelihood that regulators or law enforcement suddenly appear on your doorstep.  But preparation for emergencies and uncertainties is the key to reducing the risk that non-compliance leads to lengthy business interruption.  Although you may be saying “if”, you really should be thinking and acting more like “when”.  It costs everything to be ill-prepared and it costs very little to be well-prepared.  The following preparation can prevent much of the uncertainty that arises in these cases.

POLICIES AND PROCEDURES

First and foremost, make sure you have well-developed policies and procedures for what to do in such instances.  You should review these policies and procedures with your employees regularly, focusing on the importance of compliance.  Out of fear and uncertainty, employees can do things that create unnecessary challenges.  Educating them as to what their rights and responsibilities are will mitigate those risks.  Make sure your policies and procedures include the designation of who is in charge (“person in charge”) when the government does show up.Continue reading

Pharmaceutical Company Brings Lawsuit in Florida to Stop Alleged 340B Fraud

Pharmaceutical Company Brings Lawsuit in Florida

gilead complaint november 2020By: 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

What’s All This Talk About 340B Discount Drug Programs?

340B Discount Drug Program

340B Discount Drug ProgramBy: Jackie Bain

There has been so much in the news lately about 340B Discount Drug Programs and the fraud that accompanies them.

The 340B Discount Drug Program allows manufacturers participating in Medicaid to agree to provide outpatient drugs to certain designated clinics and hospitals at significantly reduced prices. The typical discount ranges from 30% to 50% off the drug’s list price. In turn those clinics/hospitals are able to reach more high-risk, high-need patients and provide more comprehensive services. Each designated clinic/hospital involved in the program is called a “covered entity.”

Covered entities may provide drugs purchased through the 340B Discount Drug Program to all eligible patients of that covered entity, regardless of a patient’s payer status. In order to be a “patient” of a specific covered entity, an individual (1) must have an established relationship with the covered entity such that the covered entity maintains records of the individual’s care; and (2) must receive care from a professional employed by or contracted with the covered entity such that responsibility for the care remains with the covered entity. Under the guidelines, an individual is not considered a patient of the covered entity if the individual only is dispensed a drug for the patient to take at home.Continue reading