Florida Medical Device Company Settles $16 Million Case

November 10th, 2021 by

Enforcement against medical device companies is not new and yet, these companies continue to engage in schemes that land them in hot water.  Frequently the same schemes are repeated over and over- some form of payment by the device company to a physician who selects/recommends the device to patients.  In some cases, the payment is in the form of an honorarium for speaking engagements.  In others, the payment is an all-expense paid travel to attend device company-sponsored “CME” in exotic locations or consulting fees for assisting in the evaluation and design of the device.

Announced yesterday by the U.S. Department of Justice (DOJ), is the settlement of allegations against Florida-based Arthrex Inc., a medical device company that specializes in orthopedic products.  Under the settlement agreement, Arthrex will pay $16 million for allegedly paying kickbacks to an orthopedic surgeon (Dr. Peter Millett) in Colorado.  The “payment” in this case was structured as royalty payments purportedly to compensate the orthopedic surgeon for his “contributions” to the development of two of Arthrex’s products when in fact the “payment” was intended to induce the surgeon’s recommendation/selection of the Arthrex products.  By offering the payments to the surgeon with the intent to induce purchase of Arthrex’ products which were then billed to Medicare, Arthrex violated the Anti-Kickback Statute (AKS) as well as the False Claims Act. read more

Importance of Communication During Care Transitions

September 28th, 2021 by

Over nearly the last two years, nothing has become more evident that the importance of clear and concise communication during care transitions.  As health care facilities struggled to manage the burgeoning demand for inpatient beds, and in particular ICU beds, care transitions were fast and furious.  To facilitate care delivery and expedite care transitions, CMS issued numerous 1135 COVID-19 Emergency Declaration Blanket Waivers.  Examples (not an exhaustive list) of those blanket waivers related to required communications that may have affected the quality or safety of care during and immediately after care transitions include:

  • Allowance of audio-only telehealth for certain services.
  • Waiver of the requirement to authenticate verbal orders within 48 hours.
  • Restrictions on patient rights regarding visitation, particularly where an outbreak of COVID exists.
  • Limitations on detailed information sharing for discharge planning for hospitals and critical access hospitals.
  • Extension of time within which to complete medical records following discharge.
  • Expansion of role of allied health professionals, reduction in physician supervision requirements in certain settings, and
  • Waiver of requirement to develop and keep current a nursing care plan for each patient.

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What Are Business Operations in Healthcare?

July 27th, 2021 by

Healthcare business operations provide a strong infrastructure of administrative, legal, and financial practices that allow your business to function smoothly.

When this structure is based on a few key guidelines, your healthcare business operations are more likely to be effective, increasing transparency and decreasing confusion within the organization.

Here’s what you need to know to get your organization on track.

Why Do Business Operations Matter in the Healthcare Industry?

Whether your business serves other businesses or works directly with patients, if your business operations are solid, you are better able to provide both patients and employees with a fluid and positive experience.

When customers can count on you and employees know how to handle any given situation, there are fewer “fires” to put out, giving senior management more time to focus on expansion and special projects.

What Healthcare Business Operations Are Necessary?

Solid operation of a healthcare business plan begins with knowing where to begin and what the options are.

Here are just a few areas of focus that can take your business operations to the next level:

  • Start with what you have. You may already have systems in place that are functioning at least to a degree. Starting where you are, and assessing what needs to be fixed and what needs to be kept, can help you to get on track more quickly than starting from scratch.
  • Choose the tools that fill in the gaps. Once you have a firm idea of what is working in your business, you can specifically address the things that need your attention with new software and integrations. In some cases, this can mean upgrading current systems or making a few of the clunkier ones obsolete, but it always ends with an integrated system that provides for a more cohesive customer experience and improved employee productivity.
  • Identify the data you want to track and use in your business. Depending on the goals of your company, it will be useful to track customer habits, demographics, and needs in different ways. Building your business operations plan means identifying the data that will be most useful to your company and building in processes that track it automatically.
  • Increase the automation in your business. From the intake of prospective leads to scheduling to the processing of information, the more automation you can add into your business operations plan, the more efficient your business will be. Choosing your business plan can include setting up automatic processes that limit mistakes in processing and missed opportunities.

What Healthcare Operations Plan Is Right for My Business?

It’s always a good idea to begin with a healthcare business operations plan based on the needs of your unique business. Contact Florida Healthcare Law Firm today to set up a consultation so we can help you update your business operations.

Noncompetes, Healthcare and a New Executive Order

July 15th, 2021 by

On July 9, 2021, President Biden signed a far-reaching Executive Order that could have significant impact on the healthcare industry.  Under the Executive Order, President Biden:

– Encourages the Federal Trade Commission to ban or limit noncompete agreements, and to ban unnecessary occupational licensing restrictions;

– Supports the practice of state and tribal programs importing drugs from Canada;

– Directs HHS to increase support for generic and biosimilar drugs, and to issue a comprehensive plan to, “combat high prescription drug prices and price gouging” within 45 days; read more

How Medical Technology Impacts the Law

July 9th, 2021 by

Government agencies, universities, and private corporations invest heavily in the development of medical technology.

Not only does the latest research reveal new machines and options for treatment, but they can also improve on past technology and identify where past treatment methodologies may have erred.

This is good news for patients because it means that there is an active investigation into the best treatment practices for a range of disorders.

It is also good news for labs, healthcare businesses, pharmacies, and organizations involved in telemedicine and telehealth because they can stay at the forefront of the industry and better serve their clients.

How Does Medical Technology Impact the Law?

Healthcare law is in place to protect patients and their families as they undergo medical treatment, often for serious acute or chronic illnesses.

The laws help to ensure that they get the information they need, are treated fairly, and have access to all the best possible care.

They also help to protect healthcare businesses from frivolous lawsuits, misinformation, and targeting by other businesses that want to eliminate competition.

When medical technology changes — either it becomes obsolete or is improved — it is important that the laws quickly shift to include these changes so that all parties are aware.

Why Should Florida Healthcare Law Matter to Patients?

Florida healthcare law must evolve as medical technology changes so Florida patients and benefits are protected.

Keeping up with changes in medical technology within the law can help businesses to protect their interests.

Has My Business Been Impacted by Changes to Healthcare Law in Florida?

Every business is different, and depending on your area of concern, the services you provide, and how those services are impacted by changes to medical technology, your business will need to pivot differently than another might.

If you would like to speak to a legal expert on how changes in medical technology may impact your business practices and current contracts, reach out to Florida Healthcare Law Firm today to schedule a consultation.

Gov. DeSantis Vetoes No-fault Repeal Legislation

July 1st, 2021 by

Today marks a big win for Chiropractors, the Florida Chiropractic Association, and other medical providers that treat patients as a result of a motor vehicle accident. Legislation was presented earlier this year which would have completely changed how the personal injury protection (“PIP”) industry would impact medical providers. The legislation is known as Senate Bill 54 (“SB 54”).

SB 54 was sought to end the requirement that Floridians purchase $10,000 in PIP coverage and would instead require mandatory bodily injury (“MBI”) coverage that would pay out up to $25,000 for a crash-related injury or death. This would have meant that for each case before a provider would be paid by the patient’s car insurance coverage, fault would have to be determined through litigation which would have increased the time it would have taken providers to be paid. In today’s landscape providers are able to bill the patient’s PIP coverage for the initial $10,000, and be paid 80% of the billed charges immediately, and if this law would have passed each treating provider would have had to either bill the patient’s health insurance, or treat patients on letters of protection.

In Governor DeSantis’s veto letter he wrote, “While the PIP system has flaws and Florida law regarding bad faith is deficient SB 54 does not adequately address the current issues facing Florida drivers and may have unintended consequences that would negatively impact both the market and consumers.”

Due to the potential repercussions this legislation would have had on an entire industry it is very important for all medical providers today to continue and evolve with the changing landscape. Although providers can take a breather today, because the battle is now over, they must begin to think about how their practices would have been impacted if they could have only billed patient’s health insurance or treated patients on letters of protection. Many providers that I have spoken with were not sure what they would have done, and one piece of advice I always give is that now is the time to start thinking ahead to the future. Meaning, if this law were to present itself again you all have to ask yourself would your practice be able to survive not being paid for months or years? Providers need to start considering how they can better evolve to provide better care to their patients while still being able to survive in the event PIP is repealed in the future.

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Health Care Fraud Enforcement Continues to Rock Pharmacy Industry

April 30th, 2021 by

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. read more

Permissible Payments For Referrals Under The Federal Anti Kickback Statute

April 28th, 2021 by

anti kickbackBy: Karen Davila

The term “payment for referral” strikes fear in the hearts of health care providers throughout the country because of the significant prohibitions under the federal Anti-Kickback Statute (AKS).  And, Florida’s Patient Brokering Act (PBA) casts an even bigger shadow over arrangements involving payment in exchange for referrals.  There are other statutory restrictions as well, which may apply depending upon the services for which a referral is being made.  Those include but are not limited to statutes prohibiting physician fee-splitting and the federal Eliminating Kickbacks in Recovery Act (EKRA) (applicable to referrals to recovery homes, clinical treatment facilities, or laboratories in an effort to stave off growing opioid-related fraud), and the potential collateral damage of a false claim under the federal False Claims Act (FCA) if any of the above statutes are violated.

So, is there any scenario where a payment may be made by a health care provider in exchange for referrals?  The answer is yes- there is a safe harbor under the AKS (42 U.S. C. §1320a-7b(b)) specifically for such arrangements.  This safe harbor is not commonly used and likely means revision to existing arrangements to come into compliance with its specific requirements.  But it may be worth considering if the referral (and payment for that referral) is not otherwise prohibited as noted above. read more

Five Reimbursement Denial Reduction Tips

April 25th, 2021 by

EOBBy: Zach Simpson

  1. Review EOBs and determine where denials are originating and their root cause

While reviewing EOBs practices need to determine if a trend can be established that identifies the root cause for why claims are being denied. Trends can be established by asking if most denials are originating in your patient access and registration departments, or are denials occurring because of insufficient documentation, or due to billing or coding errors?

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Is Your Office Utilizing An Outdated Advanced Beneficiary Notice of Non-Coverage Form?

April 22nd, 2021 by

medicare abnBy: Zach Simpson

Does your office treat Medicare or Medicaid beneficiaries? If so, this article is vital to you and your staff. The first question that I want all of you to ask yourself is if your practice treats Medicare or Medicaid beneficiaries do you know what an ABN is, and why they are vital for your practice? The acronym ABN stands for Advance Beneficiary Notice of Non-coverage. ABNs safeguard your practice’s right to collect on non-covered services (other than statutorily excluded services) from patients who have Medicare or Medicaid. Multiple organizations I have worked with throughout my career had never been informed about ABNs or had never been properly educated on how utilize them. This article is intended to provide you and your practice with the most recent information regarding the renewed ABN form that became mandatory for use on January 1, 2021.

As of January 1, 2021, a new Fee-for-Service Advanced Beneficiary Notification of Non-coverage became effective until it expires on June 30, 2023. In the event that your practice has been utilizing the same ABN forms for years then listen up. read more