Karen Davila

Board Certified in Health Law (Florida)

About me

“From national corporations to local family-run businesses, healthcare law is never a “one size fits all” approach. Adaptability is key. I’m focused on delivering prompt, practical and right-sized legal advice which supports the strategic vision of each client.”

Background highlights

Nearly 30 years of extensive experience in large hospitals as general counsel focused on healthcare regulation and healthcare pharmacy operations in corporations like Wal-mart.

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Recent articles

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By: Karen Davila

For some reason, wearing or refusing to wear masks has become a point of personal expression and a topic charged with much emotion.  We hear stories every day about confrontations with consumers in the retail industry.  But what about when a patient refuses to wear a mask?

In many states and counties, face coverings are still mandated in public.  Failure to wear a mask can result in civil or criminal fines or penalties.  In a medical practice, even where not required by local authorities, masks may be required.  In fact, some of the state Boards of Medicine have adopted minimum standards for safe practice.  Those standards frequently include the requirement for both provider and patient to wear masks during all health care encounters.  Where the regulations or Board of Medicine standards require all individuals to wear face coverings, a health care provider is well within his/her right to enforce those regulations within the office where health care services are being provided and to discharge a patient who refuses to comply.  However, caution must be exercised when discharging a patient from a medical practice.

Read on.

By: Karen Davila

Can an employer require employees to be vaccinated against influenza?  And, a COVID-19 vaccine likely will be approved in the not-to-distant future.  What about that vaccine when it becomes available?  These are questions with which many organizations are grappling today.  With the confluence of what is expected to be a very active influenza season and the ongoing and unprecedented COVID-19 pandemic, employers are contemplating how best to protect their workforce and clients/customers/patients.

One of the most effective ways to achieve this is a mandatory vaccine policy, but is that right for your organization?  Mandatory vaccination programs are not new.  Depending on your business, a mandatory vaccine policy may be the industry norm.  What factors should you consider?  What processes would you need to develop to address exceptions?

CAN YOUR BUSINESS MANDATE VACCINATIONS?

In general the answer is yes.

Read on.

By: 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 on.

By: 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.

Read on.

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