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2021 Pharmacy Enforcement Actions in Full Swing

by admin on February 5, 2021 No comments

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.

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COVID Vaccine Administration and Billing

by admin on February 3, 2021 No comments

By: Dean Viskovich

On November 13, 2020 Centers for Medicare and Medicaid Services (CMS) announced that all Americans will have access to the COVID-19 vaccine at no cost.  CMS has clearly communicated to private insurers, Medicaid programs and Medicare that it is their responsibility to cover the vaccine at no charge to beneficiaries.  CMS states that Operation Warp Speed ensures that States, provider’s and health plans have the information and direction they need to ensure broad vaccine access and coverages for all.  As a condition of receiving free COVID-19 vaccines from the federal government, providers will be prohibited from charging consumers for administration of the vaccine.

Beneficiaries with Medicare will not pay anything for the COVID-19 vaccine and their coinsurance/copayment and deductible amounts will be waived.  In 2021, for Medicare Advantage beneficiaries, Medicare will pay directly for the vaccine and its administration for those enrolled in MA plans.  MA plans are not responsible for reimbursing providers to administer the vaccine.  MA beneficiaries do not pay for the vaccine and copayment/coinsurance and deductibles are waived.

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Examples of Medical Cases a Business Law Lawyer Could Handle

by admin on January 22, 2021 No comments

business law lawyer floridaYou may think that your medical firm doesn’t need a business law lawyer. The three examples we provide here might change your mind.

Look over your organization chart, and you’ll see plenty of people who can handle common issues you’ll face. Human resources specialists, compliance officers, and safety officers are just a few of the staffers you can count on.

But if you don’t have access to a business law lawyer, you could be missing out on key protections that could impact both your business and your bottom line.

What Does a Business Law Lawyer Do?

All lawyers aren’t created equal. Some lawyers focus on specific types of work that apply directly to your work as a healthcare organization.

Business law lawyers are focused on the rules and regulations that govern commercial transactions. In a healthcare organization, that can mean:

  • Compliance. Are all aspects of your business handling their work in accordance with state and federal laws?
  • Employment. Are you striking the right balance between protecting your business and respecting your employees’ rights?
  • Contracts. If you have partners that deliver part of your work, are they acting in an ethical and protected manner?

If you don’t have a lawyer like this on staff, your Florida medical business really could be at risk.

3 Real-World Lawsuits

Plenty of other healthcare organizations have worked with business law lawyers in the past. Looking over their cases could entice you to do the same.

These are three examples:

  1. Florida: In 2018, a healthcare system was accused of recruiting physicians despite the knowledge of competing employment contracts that were in place.
  2. Tennessee: In 2019, a healthcare organization came under scrutiny for a set of processes involving unpaid medical bills. The policies seemed to discriminate against low-income people.
  3. Tennessee: In 2009, a medical association engaged in legal action against a recovery contractor. That subcontractor engaged in behavior the association disagreed with.

Any or all of these suits would benefit from the help of a business law lawyer, just like the ones we have on staff.

If you have a Florida medical business, we’d like to help you protect it. Contact us to find out about our services and what we can do for you.

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What Does a Medical Attorney Do?

by admin on January 21, 2021 No comments

Healthcare Practice AttorneyA medical attorney can defend you in court. Learn how these professionals can also help you to examine and amend your business so you avoid lawsuits altogether.

Watch a movie about a medical attorney, and you’re destined to see plenty of courtroom scenes. While it’s true that defending a client in court is a big part of a medical attorney’s job, attorneys do much more for their clients. And often, their work keeps clients out of the courtroom altogether.

3 Ways a Healthcare Practice Attorney Can Help

Medical attorneys working in a private practice like ours tackle all sorts of disparate tasks. They’re all rooted in the law, of course. But the connection may not be clear at first glance.

A healthcare practice attorney with our firm might help you to:

  • Avoid risk. Every employee within a healthcare organization deals with matters of life and death. Tiny mistakes can lead to big lawsuits. We help to ensure our clients are complying with local, state, and federal laws. We can even assist with training programs to educate staff about their responsibilities.
  • Handle paperwork. You can’t put up a sign and start helping clients. You must hold the proper accreditation. Your facilities and staff must be certified. And you need the right licenses too. Our medical attorneys can handle these tasks for you.
  • Draw up contracts. Hiring employees means negotiating benefits, drawing up non-compete clauses, ensuring that ethical clauses are met, and more. These are extremely time-consuming tasks, but they are critical. A healthcare practice attorney can help.

Our staff can handle many other tasks that we’re not including here. We pride ourselves on creating the right mix of help for each client.

How to Choose the Right Law Firm

Plenty of companies hope to entice you to sign with them. Learning how to separate a good medical attorney from an inexperienced one isn’t easy.

Experts say a good lawyer will do these things at the start of a contract:

  1. Explain your options.
  2. Discuss the strategy.
  3. Offer a timeline.
  4. Answer questions.

We would argue that a medical attorney should do more. The right firm will demonstrate expertise, offer references, and provide proof of value. We’re ready to do all of those things for you.

Contact us to learn why we’re considered the primary healthcare law firm in Florida.

 

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DME Competitive Bidding Round 2021 – Now What?

by admin on January 8, 2021 No comments

fhlf medicareBy: Michael Silverman

Medicare’s DMEPOS Competitive Bidding Round 2021 is now in full effect as of January 1, 2021. (See previous articles about what CBID Round 2021 is all about).

DME providers either participated in the process with hopes of being awarded a bid, or they abstained from doing so. Of those who participated, with Medicare’s recent bid winner announcements, bid winners were happy and bid losers, well not so much – as only those providers awarded a contract could service a Medicare Part B beneficiary for competitively bid product(s) for patients residing in competitive bid areas (“CBA”).

Now what? What are the options for the relationships between ‘winners’ and ‘losers’ in moving forward, if any? Let’s briefly discuss subcontracting.

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How Autonomous Practice Is The Biggest Business Opportunity for 2021

by admin on January 6, 2021 No comments

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.

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Recap: Dental Employment Contracts

by admin on January 6, 2021 No comments

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.

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What to Do When The Government Comes Knocking

by admin on January 3, 2021 No comments

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.

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

by admin on January 1, 2021 No comments

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.

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How to Protect Your Pharmacy From Risky Prescriptions

by admin on December 31, 2020 No comments

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.

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