2021 Pharmacy Enforcement Actions in Full Swing

compounding pharmacy

By: Michael Silverman

The new year has brought with it no lull in pharmacy fraud crackdowns and enforcement actions, with allegations related to over one billion dollars in false claims.

Here’s a breakdown of the latest:

Mississippi Man Sentenced to 18 Years in Prison and $287,659,569 in Restitution

This individual spearheaded a scheme involving kickbacks to marketers and prescribers to defraud TRICARE and other healthcare programs by submitting claims for unnecessary compounded medications, which also involved routine waiver of patient financial responsibility. Continue reading

How Autonomous Practice Is The Biggest Business Opportunity for 2021

fhlf nurse practitioner law

fhlf nurse practitioner lawBy: Chase Howard

With the passage of autonomous practice ability for nurse practitioners in Florida this year, many are wondering how this will affect the healthcare industry in Florida. In a traditional sense, rural and underserved areas should have the opportunity for growth in healthcare providers. The autonomous practice law removes restrictions on certain nurse practitioners, granting them the ability to practice in primary care practice settings without worrying about supervision restrictions. Outside of that, the application of the new law can expand healthcare business offerings and abilities. Continue reading

Recap: Dental Employment Contracts

Dental Employment Contracts

fhlf dental lawBy: Chase Howard

Many young dental professionals are presented with the opportunity to join a practice after graduation. Making an informed decision and negotiating a fair contract can be difficult but will ultimately pay dividends for years to come. Here are some items to consider when reviewing and negotiating your employment contract.Continue reading

Company Model Scrutiny For Physicians After Daitch Case

fhlf daitch case

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.

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Weave Compliance Into Your Practice For 2021

Weave Compliance Into Your Practice For 2021

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.

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Healthcare Marketing: Measure Twice, Cut Once

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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—Continue reading

Forward Looking: How to Prepare for 2021

fhlf healthcare business law

We’ve all learned a lot in 2020, but are we prepared for what 2021 will bring? The change of the calendar won’t make the pandemic go away, but you can prepare your medical practice.

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PPP Standing in the Way of Healthcare Mergers and Acquisitions

PPP Standing in the Way of Healthcare Mergers and Acquisitions

fhlfhealthcaretransactionsduringpandemicBy: Susan St. John

The trend that we are seeing affects both buyers and sellers in the health care sector with respect to entities that have received cash infusions from the Paycheck Protection Program (“PPP”) created pursuant to the CARES Act in response to COVID-19. Mergers and acquisitions can come to a significant slowdown, standstill or be terminated altogether if careful planning is not performed to account for the impact the PPP funds received by a healthcare target or seller will have on an anticipated merger or acquisition.  While tax and legal considerations have typically followed along with the merger or acquisition and these considerations are important aspects of any merger or acquisition, they have taken a forefront position when it comes to planning for a change of ownership when the healthcare target or seller has received PPP funds.

As we learned earlier, health care entities requested and received PPP funds to sustain them during the public health emergency caused by COVID-19, allowing them to avoid a virtual economic shut-down. These funds were a welcome relief to keep health care entities afloat financially, providing a way to cover certain expenses such as a) payroll costs, b) rent, c) interest on any covered mortgage obligation (which shall not include any prepayment of or payment of principal on a covered mortgage obligation), and d)  utilities. Using the PPP funds on these expenses allows for a recipient of the PPP funds to qualify for loan forgiveness under the PPP. That all seemed like welcome relief at the time.Continue reading