Category:

Genetic Testing: Be Hopeful but Wary

July 26th, 2021 by

Genetic tests are valuable because they can provide important information to patients and their medical providers regarding diagnoses, treatment, and disease prevention. However, the rapid growth in the number of tests ordered, especially in light of the telemedicine expansion during the pandemic, has invited well-earned scrutiny to the industry.

Make no mistake: genetic testing is heavily regulated (and enforced). The Federal Anti-Kickback Statute, Eliminating Kickbacks in Recovery Act, and Commercial Insurance Fraud Law have all been used to prosecute unscrupulous marketers, call centers, and telemedicine providers in the last few months. Kickbacks in exchange for genetic specimens are just as illegal as kickbacks for patients. Three months ago, a Florida man was sentenced to 10 years in prison for conspiracy to commit health care fraud. His actions resulted in the submission of approximately $3.3 million in fraudulent claims to Medicare for genetic testing. 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

Fraud & Abuse Healthcare Law

May 12th, 2021 by

Healthcare fraud law should be easy to understand. If you don’t set out to lie, cheat, or steal to make money, you should be safe, right?

Unfortunately, the laws can be incredibly complex. Add in partnerships and sophisticated work-sharing agreements, and untangling the mess of responsibility could be even more difficult.

We’ll explain a few examples of healthcare law and fraud to make the problem easier to understand. But know that it’s always wise to contact a lawyer when you think you’re engaged in activity that could be considered fraudulent.

Inadvertent Healthcare Fraud Cases

Sometimes, the decisions you make as a healthcare professional break the laws, even if you never intended to do so.

Consider the Stark Law. Under that statute, you’re not allowed to refer a Medicare patient to any entity with which you have a financial relationship. In theory, you could break that law by:

  • Referring patients for tests and accepting a portion of the fees billed for those tests.
  • Giving your doctors an incentive for some kinds of tests.
  • Improperly paying your physicians
  • Making an arrangement with a medical center and promising to refer patients for some kinds of tests.

Inadvertent fraud is real, and these cases are complex. It’s wise to work with a lawyer, especially if healthcare arrangements are involved.

What About the Healthcare Fraud Law False Claims Act?

You can’t submit Medicare or Medicaid claims you know are fraudulent. Doing so is a violation of the False Claims Act, and fines are steep.

Typically, healthcare professionals know that they’re breaking this particular fraud law. They doctor the paperwork and hope to make money before anyone notices. But sloppy bookkeeping could also play a role. If you’re not absolutely sure that you’re submitting everything properly, wait and think before you take action.

Healthcare Fraud Law: Criminal Statutes

Sometimes, your mistakes aren’t inadvertent or paperwork related. If you intend to break the law and you know your conduct is wrong, you could be liable for criminal charges.

Two main criminal statutes apply to medical professionals, and they involve:

  • Kickbacks. If you get something in return for Medicare or Medicaid business, you’re involved in an illegal scheme.
  • Fraud. If you intend to falsify records or documents for your financial gain, you could face legal challenges.

Criminal charges could end your career. And they could also put you in jail for long periods of time.

What Should You Do When You Suspect Fraud?

If you’ve been reading this list with a growing suspicion that you’re engaged in something unethical, take action.

The government recommends:

  • Stopping. Don’t submit anything else that’s fraudulent.
  • Assessing. Determine how much you’ve made on the scheme.
  • Untangling. If you’re part of a scheme to defraud, get out of those relationships.
  • Disclosing. Own up to the mistakes you’ve made before you’re caught.

You should also work with legal counsel at this point. At Florida Healthcare Law Firm, we can help you assess the damage and find a proper path forward. Contact us for a confidential conversation.

Orthotics and Fitter Requirements – Clearing the Air for Medicare Enrolled DMEPOS Providers

March 14th, 2021 by

dmepos orthoticsBy: Michael Silverman

Also Available in Video Format!

With off-the-shelf knee and lumbar orthotics (HCPCS Code OR03) included in Medicare’s Round 2021 of Competitive Bidding (and thus ability to supply such devices to beneficiaries living in competitive bid areas limited to bid-winners), non bid-winning DMEPOS providers have been scrambling to find new revenue streams for their business models.

Many such providers are looking to continue providing orthotics – such as prefabricated (HCPCS Code OR02) or custom fabricated (HCPCS Code OR01) braces.

Unfortunately, a misunderstanding that could jeopardize Medicare billing privileges seems to be spreading. It pertains to DMEPOS provider personnel/fitter requirements to enable billing for such prefabricated or custom fabricated orthotics; allow me an opportunity to clear the air. 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

Florida Healthcare Law Firm Begins the New Year with the Addition of Attorney Karen Davila, Pharmacy Law Specialist

January 1st, 2021 by

fhlf karen davilaFollowing last year’s growth expansion, Florida Healthcare Law Firm in Delray Beach, FL has hired board certified attorney (in Health Law) Karen Davila, as of January 4, 2021. Karen will play an essential role representing healthcare businesses with a specialized focus on retail pharmacy owners and operators. Karen has nearly 30 years’ experience in the health law space and is licensed in both Florida and Illinois.

Florida Healthcare Law Firm has announced that they have added Karen Davila to the team. Karen brings a wealth of healthcare business expertise working with national corporate pharmacies, large hospitals and local family-run businesses. As part of the firm’s expert pharmacy law team, Karen will advise independent pharmacies on matters such as PBM audits, regulatory compliance and transactional support. She also has experience complex provider relationships, reimbursement, fraud and abuse, DEA and FDA regulatory compliance, scope of practice of health care professionals, and quality/patient safety issues across the health care continuum. read more

How to Protect Your Pharmacy From Risky Prescriptions

December 31st, 2020 by

fhlf protect your pharmacyBy: Karen Davila

Pharmacies and their pharmacists are in a very tough spot in the current regulatory enforcement environment.  This is particularly true with dispensing controlled substances. Headlines like the below are commonplace:

DEA RAIDS PHARMACY AS PART OF LOCAL DRUG SWEEP

PHARMACY PAYS $500,000 IN PENALTIES FOR CONTROLLED SUBSTANCES ACT VIOLATIONS

MAN ARRESTED USING DOCTOR’S PRESCRIPTION PAD TO WRITE FRAUDULENT RX’S

So, how do you avoid filling a fraudulent prescription for controlled substances?  Before getting into the nitty gritty, it is important to lay the foundation of standard of care and the corresponding responsibility so pharmacies and pharmacists can evaluate what steps are most likely to mitigate these risks.

As background, federal law states that the primary responsibility for prescribing controlled substances rests with the prescriber.  However, that same law places a “corresponding responsibility” on the pharmacist to assure each prescription is written for a legitimate medical purpose pursuant to a valid patient-prescriber relationship.  21 CFR §1306.04(a).

Under Florida law:

  1. A pharmacist may not dispense a Schedule II-IV controlled substance to any patient or patient’s agent without first determining, in the exercise of her or his professional judgment, that the prescription is valid. F.S. §893.04 (2)(a).
  2. A prescriber or dispenser must consult the prescription drug monitoring system, eForce, to review a patient’s controlled substance dispensing history before prescribing or dispensing a controlled substance.S. §893.055

Once you have a clear understanding of a pharmacist’s liability, you can then consider ways to mitigate the inherent risks in filling controlled substance prescriptions. read more

Company Model Scrutiny For Physicians After Daitch Case

December 11th, 2020 by

fhlf daitch caseBy: Jeff Cohen

A 2018 Department of Justice civil settlement involving a Florida interventional pain physician was a cliff hanger when it surfaced, especially vis a vis the issue of the so-called Company Model, where anesthesiologists and referring physicians jointly owned an anesthesia provider.  The Daitch settlement involved interventional pain specialists who settled the case for $2.8 Million.  There, the government claimed that a mass of urine drug tests weren’t reasonable or medically necessary.  But the issue buried in the settlement call the issue of intertwined medical businesses and the Company Model into question.

The so-called Company Model involves the formation of a company that provides anesthesia services.  It’s jointly owned by anesthesiologists and referring physicians.  Theoretically, on a Monday, the anesthesiologists own the anesthesia practice and bill for all anesthesia services performed at a GI lab or ASC.  On a Tuesday, however, the new company (jointly owned by the same anesthesiologists and the referring physicians) steps in and starts billing for the anesthesia services, thus indirectly sharing a part of the profits with the physicians who are generating the anesthesia referrals.

read more

Weave Compliance Into Your Practice For 2021

December 8th, 2020 by

fhlf regulatory complianceBy: Jeff Cohen

A recent Department of Justice $500,000 settlement with a cardiology practice underscores the need for ensuring tighter compliance by medical practices.  There, the practice billed Medicare for cardiology procedures for which interpretive reports were also required.  Medicare paid for the procedures, but upon audit, CMS could not find the requisite interpretive reports.  The False Claims Act case settled for $500,000, but it’s likely that (1) the reimbursement by Medicare was far less, and (b) the legal fees behind the settlement weren’t too far behind the settlement amount!  Had the practice self-audited each year, would they have found the discrepancy?

Medical practices have felt the weight of price compression and regulatory load more than probably any segment in the healthcare sector.  They are doing far more for far less.  And regulations expand faster than viruses!  Hence, many have a strategy of regulatory compliance that can best be characterized as a combination of facial compliance (“We bought the manual and put it on the shelf”) and hope (“They’re not really serious about this, are they?”).  Unless you’re part of a practice of more than 20 doctors, it’s likely that you can do more to ensure regulatory compliance.

read more

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

November 10th, 2020 by

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. read more