On March 29, 2021, Florida Governor Ron DeSantis signed the “Civil Liability for Damages Related to COVID-19 Act” into law. The Act was designed to shield businesses from COVID-19 liability claims, and includes a specific section dedicated to protecting healthcare providers. While the protections for healthcare providers are not as robust as those granted to other businesses, the immunity provided by the law (Florida Statutes s768.381) is significant.
The protections apply to virtually all Florida healthcare providers, regardless of whether they are individuals, agencies, or facilities; and cover all “COVID-19 related claims.” The types of claims covered are those arising from:
Medical Spas nationwide, but specifically in Florida, have been opening up at a staggering pace. For many reasons, including new services, technological advances, and lax regulations, the opportunities for medical spa businesses are endless.
In 2010, there were about 1,600 medspas operating in the United States generating about $1.1 billion in revenue (about $700,000 per medspa on average). By 2018, these numbers increased to over 5,000 medspas generating about $7 billion-$8 billion in revenue (about $1.4 million per medspa on average). The number is expected to grow to over 10,000 medspas by 2023 with about $18 billion-$20.7 billion in revenue.
While medical spa owners have taken advantage of these opportunities, state authorities have yet to keep up. The medical spa industry is largely unregulated, whether that be due to the nature of the services provided, or the explosive growth in this alternative type of medical clinic. On top of that, there’s been a expansion in scope of practice and supervision requirements for certain providers, including nurse practitioners.
In today’s practices there are many circumstances that call for the discarding of unused portion of drugs, and because of this drug waste can be a big-money issue for many practices. A perfect example is Botox which must be used within five hours of reconstitution, and if it is not used within that timeframe the only option a provider has is to discard the unused supply. What many providers may not be aware of though is that money can be recouped for drugs that have been discarded. The aim of this article is to educate providers that when applicable they may report drug waste in addition to the drug and its administration for Medicare Part B claim reimbursement.
How to Properly Report
For a provider to recoup and report the drug waste they must report the administered drug using the appropriate HCPCS Level II supply code, and the correct number of units in box24D of the CMS-1500 form. As a second line-item providers will want to enter all of the wasted units. It is very important to ensure that the provider documentation verifies the exact dosage of the drug injected, and the exact amount of and any reason for waste. Be aware If the provider did not assume the cost of the drug or administer the drug to the patient they may not bill for the unused portion.
In addition to listing the wasted units as a second line-item certain local contractors may require you to use the modifier JW Drug amount discarded/not administered to any patient to identify an unused drug from single-use vials or single-use packages that are appropriately discarded. Be aware that is inappropriate to use the modifier JW with an unlisted drug code. Therefore, it is imperative to be aware of the local contractor requirements, and appropriate drug codes.
Due to the increasing number of forms being required these days it is all too common for practices to get lost in the vast terminology, rules, and coding requirements that have to be followed as well. An area that practices have one of the most difficult times with is operationalizing the issuance of an ABN properly. I am frequently asked to consult for practices that ask who does which part, when, and with whom in regards to ABNs? In other instances, many practices I have worked with simply make the mistake that they can solve the complexities of trying to understand the nuances of how to properly utilize ABNs by deciding to issue ABNs to every Medicare patient for every service which is not a viable option either. The solution that many offices try that I just described is called issuing blanket ABNs, which in turn may cause Medicare to invalidate all issued ABNs from the practice, including those that may been appropriate which is why it is very important that blanket ABNs are never issued.
One thing in common with practices that issue ABNs in a proper manner is that they all have a process in place for identifying potential denied services prior to delivering them. To many practices this may sound easy, but to ensure that your practice is as effective as possible it will take some claims data analysis to ensure that your practice is capturing all potential opportunities for ABN issuance. The aim of this article will be to provide practices with 5 steps that will make ABN issuance easier.
In most cases, the limited liability company, or LLC, is the preferred business structure for a wide variety of healthcare businesses. If you’re a licensed professional, you can also use the professional limited liability company, or PLLC for your healthcare practice or business. While generally these two entity types are the same, there’s a small difference to be aware of when organizing the company.
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.
The year 2020 is one for the history books from the start of a global pandemic, COVID-19 shutdowns of “non-essential” businesses to a rise in telemedicine fraud schemes. Join Board certified healthcare attorney Jeff Cohen for insight on 2021 healthcare business preparation topics and lessons from 2020.
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.
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—
Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.