There’s an old saying that goes like this: To a hammer, everything is a nail. There’s another I like: There are two things in life you don’t wanna see being made: one is sausage, the other is law. Case in point is HB 369, the latest Florida law aimed at correcting certain problems in the addiction treatment industry. Though nailing some clear issues that needed shoring up, some of the provisions skate on some questionably thin ice vis a vis conflicting with federal law.
The law implemented last year is a mixed bag. This one is no different, and yet in many ways more of a modification of last year’s legislative bombshell than anything else. Some of the good stuff that the law does includes: doubling down on the credentials required to work in a recovery center. For instance, the definitions of “clinical supervisor” and “peer specialist” are both beefed up to require, for instance, a length of time of sobriety. And background checks for people working at treatment centers are featured strongly in the new law. The law also creates an exemption from disqualification for certain past offenses, which is important when qualifying people to help those in treatment who likely had a past history of abusing drugs or alcohol. The law also attempts to negate old landlord tenant laws to allow a recovery residence to discharge a resident for some very good reasons (e.g. it’s necessary for the resident’s welfare). In these ways and others, the law is thoughtful.
But HB 369 also raises some serious questions. For instance, will the new and very stringent requirements applicable to those working in treatment centers restrict the number of qualified people to an unreasonable degree? What will they do to the cost of a treatment provider hiring those services? Last year’s law attempted to disrupt nearly every type of marketing practice and marketing arrangement. This new law simply attempts to round out the surfaces on those provisions.
And the new Florida law also seems to have been…ahem…”informed” by perhaps those with conflicting business interests. Note for instance the new requirement that DCF approve “one or more third-party credentialing entities…” to certify peer specialists and others. It reminds me of when FAAR was authorized by state law to certify sober homes. Is this sort of “public/private” partnership in the best interest of treatment providers or people seeking treatment? And who’s watching the watcher? And with all the newly expanded duties of DCF, is there any reasonable assurance from the state that the job can be done? Who other than law enforcement was “at the table” to bring any counterbalancing perspectives?
Of particular concern is the conflict between this HB 369 (especially last year’s version) and the federal Anti-Kickback Statue. The state Patient Brokering Act forbade paying for patient referrals or getting paid for them. That law has been expanded significantly by addiction treatment focused law enforcement in the past couple years, to a point where it now conflicts with federal law. Treatment providers will not only have to continue to make sure they know the laws, options and risks, but also be careful to square both the state and federal law (and create a litigation fund to work through the grey areas created by the new law).
The treatment industry is admittedly a difficult area to legislate, since treatment providers refuse to organize and rush into the public arena to advocate for what they believe is right. Which leaves the door wide open to those who have the same task, but a vastly different perspective.
REITs are part of an extremely complex and diverse industry, but they can also be very profitable. Not only are there different categories of REITs, many different property types and classifications can comprise them.
Let’s start with the three types of REITs: mortgage, equity and hybrid.
There are three ways a real estate investment trust can be structured.
The first type, is a Mortgage REIT. Mortgage REITs work by creating a trust which will provide a loan and lend money to landlords and their operational teams to purchase a property. The way revenue is generated is through the interest paid on the mortgage loans. Interest can be earned either directly from mortgages or from mortgage-backed securities. Mortgage real estate investment trusts are not direct investments in specific property. Since the primary way the mortgage REIT survives is through the interest earned, many factors can make a mortgage REIT strong or weak. These factors include mortgage rates, prepayments of a loan before the due date, and credit events like foreclosure or bankruptcy.
The second type of real estate investment trust is an equity REIT. An equity REIT owns and operates income-producing real estate assets like offices, shopping centers, medical facilities, and resorts, among many other assets. This is the category where healthcare REITs fall. The real estate investment trust leases space in the facilities to tenants for rent. Most of the equity REITs operates in their core areas. For healthcare operations, this includes medical office building (MOB) development, outpatient facilities, senior housing facilities, nursing homes, and assisted living facilities. Essentially healthcare REITs are landlords to the medical world.. Many Healthcare REITS have substantial stakes in seniors housing. Some of them own the buildings outright and have tenants pay the leases, as well as the taxes and upkeep (so called triple-net-lease arrangements, or NNN). Some healthcare REITs own the property but has an operating company run the day-to-day operations.
Finally the third type of REIT is a Hybrid REIT, which is a combination of equity and mortgage REITS. This REIT generates income from rent and capital gains like an equity REIT but receives interest like a mortgage REIT.
Ransomware attacks are impacting the healthcare community’s HIPAA security at a staggering rate. If a practice has data stolen from their network and they did not report the breach to The Office of Civil Rights (OCR), they could be subject to massive fines for the lack of reporting. Specific steps must be followed to determine if ePHI (electronic protected health information) was compromised. This often involves hiring a forensics company and working with a Cybersecurity company to harden the practice’s infrastructure. When you are the victim of an attack once, you will mostly likely be a victim again because of vulnerabilities in your network that enabled the attack vector (or payload) to infiltrate your system. You cannot simply restore your data and hope for the best.
Many practices are unaware if their IT vendor, imaging company, billing company and/or software vendor are following the HIPAA laws related to compliance and Cybersecurity. As a Business Associate, they are often required to follow the same laws as the covered entity (doctor). If your IT company has a breach or ransomware attack and it spreads from their network to yours, your records have now been compromised.
To help guard against these sophisticated attacks, you need to take the following steps:
HIPAA Security – Cybersecurity Audit
A Cybersecurity company will work closely with the practice and its IT company to understand the landscape of the practice’s IT footprint. The Cybersecurity company will want to know how data is stored, what protocols are in place to protect the data and how it is accessed. They will also ask if there are remote team members, if they contract with a billing company that “logs in” to their network, if doctors leave the office with devices that store ePHI, if ePHI is transmitted and stored using encryption technologies to protect the data, etc. Many healthcare organizations rely solely on their IT company to protect their network. It is important to understand that IT companies are not Cybersecurity companies. You need the expertise and knowledge of a specialist in Cybersecurity to help ensure the security of your network.
HIPAA Security – Cybersecurity Awareness Training
As part of the HIPAA Security Rule, covered entities (i.e., your practice) are required to undergo Cybersecurity awareness training to help mitigate the risks of human error and minimize the chances of being exposed to an attack. Recent data indicates that there is a 50% to 75% reduction in cyberattacks when the staff is properly trained.
The most vulnerable components of a network are the people using it. Social engineering, often referred to as “hacking the human,” is the most prominent threat impacting practices and is often the least discussed. Most ransomware attacks are initiated via spear phishing, which is designed to fool an email recipient into opening an email that appears to be coming from someone they know or trust. An email may be sent to the staff asking them to open an attachment or click on a link to update or download something. Once they initiate the action, an executable file may run, which is a ransomware attack. The ransomware typically encrypts the current computer and will then search for other machines. Once it finds the server, the ransomware will encrypt most of, or all, of the files on the server. These files become inaccessible to anyone, unless they pay the ransom to the hackers to decrypt the data. This is typically done using a cryptocurrency such as Bitcoin or Monero. Most often, the files are not returned and, if they are returned, a timebomb attack may be set up to impact the files again. This should be reported to law enforcement.
For a breach to occur, a network typically has vulnerabilities (i.e., unpatched operating systems, outdated equipment, weak passwords, open ports on computers or firewalls, unsecure network protocols, improperly configured firewalls, etc.). Cybersecurity firms deploy very sophisticated tools to search for “open doors and windows” on your network that hackers use to exploit. This data is turned over to the practice’s IT company for remediation purposes so that the IT company can effectively lock the “doors and windows.” Cybersecurity companies invest heavily in best-in-class vulnerability scanning technologies that can detect thousands of vulnerabilities on a network. Testing should be performed quarterly or whenever network devices are upgraded, modified, or added.
Penetration testing, utilizing an ethical hacker, is performed using the same tools, techniques, and protocols that a cyber-criminal uses to try and “break into” your network. Unlike a vulnerability scan, an ethical hacker is able to problem-solve during the testing. A vulnerability scan will get to a locked “window” and not know how to progress. A hacker will see that the “door” is locked but may run a certain script to open the door. Ethical hackers use their experience to exploit networks in a way an automated tool simply cannot. After the ethical hacker has completed their testing, they turn their findings over to your IT company so they can mitigate the risks.
Employers are approaching us in increasing numbers regarding their obligations toward employees battling substance abuse. Two federal laws primarily govern the space, the Americans with Disabilities Act and the Family and Medical Leave Act. Note that state laws may be more restrictive, so we encourage our clients to reach out to local attorneys to determine if additional legal protections are available to employees in their state.
The Americans with Disabilities Act (ADA) covers businesses with 15 or more employees to protects workers from discrimination based on a qualifying disability or a perceived disability, which is defined to include alcoholism and illegal drug use. However, to be eligible, the ADA protects only workers who either (i) have successfully been rehabilitated and are no longer using illegal drugs or misusing alcohol; or (ii) are currently participating in a rehabilitation program and are no longer using illegal drugs or misusing alcohol. Importantly, the ADA does not protect any employee who is presently battling alcoholism and illegal drug use and is not participating in a treatment program. An employee in the throes of substance abuse who is not actively seeking treatment is not protected by the ADA.
Employees who seek out treatment for substance abuse can get the treatment they need and still have a job to come back to if they are employed by companies subject to the Family and Medical Leave Act (FMLA). FMLA governs businesses with 50 or more employees, and allows eligible employees to take unpaid leave for specified family and medical reasons with continuation of group health insurance coverage and return to work under the same terms and conditions as if the employee had not taken leave. Eligible employees are entitled to twelve workweeks of leave in any 12-month period for a serious health condition that makes the employee unable to perform the essential functions of his or her job, including seeking out treatment for addiction. The employer may not take action against the employee because the employee has exercised his or her right to take FMLA leave for treatment. However, if the employer has an established policy, applied in a non-discriminatory manner that has been communicated to all employees, that provides under certain circumstances an employee may be terminated for substance abuse, pursuant to that policy the employee may be terminated whether or not the employee is presently taking FMLA leave.
An employee may also take FMLA leave to care for a covered family member who is receiving treatment for substance abuse. The employer may not take action against an employee who is providing care for a covered family member receiving treatment for substance abuse. Eligible employee must have been employed by the company for 12 months prior to taking the FMLA leave, and have worked at least 1,250 hours during the 12 months prior to the start of FMLA leave.
Employees who are battling addiction with no current intention of seeking treatment are not protected in their jobs under these two laws. The ADA protects persons who have successfully completed treatment or are currently active in a treatment program. FMLA allows employees to take time off to attend treatment, but absence from work resulting from the employee’s abuse of a substance also does not qualify for FMLA leave.
Importantly, all employers who are subject to ADA and/or FMLA should have in place a written substance abuse policy allowing employees with addiction problems to feel safe to request the time off required to obtain treatment, and to understand on what terms their employment may be terminated regardless of their seeking treatment. Policies like this proactively aid employees to understand employer expectation and protect the employer from employment claims later on.
As you may have heard, the State Hemp Plan, SB 1020, has passed the Florida House and Senate and is waiting for Governor DeSantis’ action (approval or veto) or inaction (no veto). The Governor’s approval or failure to veto SB 1020 means SB 1020 will become law. So what does this mean for Florida?
SB 1020 is meant to bring Florida’s laws regarding the cultivation and processing of hemp in line with the Federal Farm Bill of 2018 which removed hemp from the DEA’s list of controlled substances and legalized the industrial use of hemp. Currently, hemp is listed as a controlled substance under Florida law. SB 1020 will change that and allow cultivation of hemp and distribution and retail sale of hemp extract.
SB 1020 is expected to become law and be effective July 1, 2019. Further, the Department of Agriculture and Consumer Services (“DACS”), in consultation with the Department of Health and the Department of Business and Professional Regulations, must initiate rulemaking to administer the State Hemp Plan. Rulemaking must begin by August 1, 2019. Further, DACS must seek approval from the US Secretary of Agriculture for the State Hemp Plan, including rules administering the plan.
So what does this all boil down to? First, the State Hemp Plan removes hemp-derived cannabinoids, including but not limited to cannibidiol, as a controlled substance or adulterant under Florida law. Further, the Legislature has found hemp to be an agricultural commodity; thus, processing hemp for an end use will not be unlawful.
Any person wishing to cultivate hemp must have a license from DACS. DACS will prescribe the form of the license application and an applicant must provide fingerprints to the Department of Law Enforcement, which will forward the fingerprints to the FBI for national processing. Fingerprints will be kept on file and cross-checked to arrest records. Anyone who has a conviction of a felony relating to a controlled substance under state or federal law, and it has not been at least 10 years since the conviction; need not apply for a license or a renewal license to cultivate hemp.
SB 1020 defines cultivating hemp as “planting, watering, growing, or harvesting hemp” Hemp may be processed for an end use, such as creating a “hemp extract.” Hemp extract is defined as “a substance or compound intended for ingestion that is derived from or contains hemp and that does not contained other controlled substances.” Hemp is defined as “Cannabis sativa L. and any part of that plant and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers thereof, whether growing or not, that has a total delta-9 tetrahydrocannabinol concentration that does not exceed 0.3 percent of a dry-weight basis.”
Great! Ingestible CBD products will become lawful in this state (finally). Further, SB 1020 places quality parameters on the distribution and retail sale of hemp extract giving health care providers and patients assurance of suitability for consumption. The hemp extract must be batch tested by an independent testing laboratory that has third party accreditation as a competent testing laboratory pursuant to ISO/IEC 17025 of the International Organization for Standardization. Independent testing laboratories must not have direct or indirect interest in an entity whose product is being tested, must not have direct or indirect interest in a facility that cultivates, processes, distributes, dispenses, or sells hemp or hemp extract or marijuana in this state or in another jurisdiction.
Hemp extract sold or distributed in Florida must be batch tested and have a certificate as to batch testing, including confirmation that the batch did not contain delta-9-tetrahydrocannabinol concentration in excess of 0.3 percent on a dry weight basis. The certificate must also confirm the tested batch does not contain contaminants unsafe for human consumption. Further, packaging for the hemp extract must include: i) a scannable barcode that links to the certificate, ii) the batch number, iii) the internet address for the website where the batch information may be obtained, iv) expiration date, v) milligrams of hemp extract, and vi) a statement concerning the concentration of delta-9-tetrahydrocannabinol. Further, SB 1020 does not require distributors, retailers, or processers to be licensed with respect to hemp extracts. So it’s a wide-open field for anyone contemplating distribution, retailing, or processing of hemp. Only cultivation requires licensing under SB 1020.
Wait – What about topicals such as creams, balms, ointments, or oils containing CBD? Will CBD topicals also be lawful? Yes. Hemp-derived cannabinoids are not controlled substances or adulterants and SB 1020 does not contain any prohibition on CBD topicals. However, SB 1020 does not include quality parameters for topicals. Thus, there could be wide variation in CBD topicals, even those that claim the same milligrams of CBD. The base substance or “vehicle” the CBD is contained in could affect its usefulness.
How does SB 1020 affect health care providers? Physicians, physician group practices, medical spas, pharmacies, or other health care providers will be able to sell hemp extracts and topicals to patients without fear of violating state law for sale and distribution of controlled substances. However, health care providers should make sure that hemp extracts meet all the quality parameters set forth above. Health care providers should also perform due diligence on distributors and manufactures of CBD topicals to make sure those products do not contain a higher concentration of delta-9 tetrahydrocannabinol than permitted under the State Hemp Plan. Further, providers will want to ensure that the hemp cultivators behind hemp products are properly licensed.
One final thought: technically, cultivation, distribution, and retail sale of hemp and hemp derivatives is currently unlawful in Florida. But times are a-changing, and once SB 1020 becomes law, Florida fully intends to enforce this law. Providers must be sure that any hemp products they carry are compliant with Florida law regulating hemp.
There has been much talk about the future of health care real estate investment trusts (REIT) and the evolution of the real estate market, as well as the way patient care is being provided in today’s world. With greater demand for outpatient and ambulatory surgical centers, the healthcare REIT market is forecasted to be a bullish market. Additional reasons for positive forecasts include an aging population with greater demand, a track record of high performance, and cost of equity capital. Investing in income-generating real estate can be a great way to increase net worth. For many, investing in real estate, particularly commercial real estate, seems to be out of reach financially. However, with the right partnerships and guidance, it is possible. REITs (pronounced “reets”) allow mall investors today to pool their resources with other small investors in order to invest in large-scale commercial real estate as a group.
So, what exactly is a REIT?
REIT stands for real estate investment trust, otherwise known as a “real estate stock.” Essentially, REITs are corporations that own and manage a portfolio of real estate properties and mortgages. If the REIT is publicly traded, anyone can buy shares and they will offer the same benefits of real estate ownership without the overhead or operational stresses that come with being a landlord.
Unlike actual real estate property, investors can quickly sell shares in a REIT, which creates an advantage of liquidity. In addition, since your investment does not solely lie in one piece of property, but a portfolio of properties, a REIT creates much less financial risk.
In order to qualify as a REIT, a company must distribute at least 90 percent of its taxable income to its shareholders each year. In 1960, President Eisenhower signed the real estate investment trust tax provision which qualified REITs as pass-through entities because there was a high demand for real estate funds.
A corporation must meet several other requirements to abide by health care REIT laws, qualify as a REIT and gain pass-through entity status. They must:
Structure themselves as corporation, business trust, or similar association
Be managed by a board of directors or trustees. The board of directors or trustee must have bylaws and an operating agreement which governs the behavior and actions of the board.
Offer fully transferable shares
Have at least 100 shareholders
Pay dividends of at least 90 percent of the REIT’s taxable income
Have no more than 50 percent of its shares held by five or fewer individuals during the last half of each taxable year
Hold at least 75 percent of total investment assets in real estate
Have no more than 20 percent of its assets consist of stocks in taxable REIT subsidiaries
Derive at least 75 percent of gross income from rents or mortgage interest
In order to qualify as a REIT, at least 95 percent of the gross income must come from financial investments such as rents, dividends, interest and capital gains. At least 75% must come from real estate sources such as rents, proceeds/gains from sale or disposition of property and any income gained from foreclosure on property.
REITs are part of an extremely complex and diverse industry, but they are also very profitable.
Not only are there different categories of REITs, many different property types and classifications can comprise them.
Let’s start with the three REIT categories: equity, mortgage and hybrid.
Stay tuned for our next article which breaks down the types of REITS and health care REIT laws.
In a decision expected to cause waves through the rapidly-expanding regenerative medicine industry, a U.S. District Court Judge ruled on June 3rd that the U.S. Food and Drug Administration (FDA) is entitled to an injunction in a lawsuit filed against U.S. Stem Cell Clinic, LLC (US Stem Cell) based in Sunrise, Florida. In her decision, U.S. District Court Judge Ursula Ungaro agreed that the FDA has the authority to regulate the popular stem cell procedure known as stromal vascular fraction (SVF) – administering processed stem cells derived from adipose tissue (i.e. fat tissue) – and that US Stem Cell is not exempt from regulation.
To recap, in May 2018, the U.S. Department of Justice (DOJ) filed complaints against US Stem Cell and a California stem cell clinic seeking permanent injunctions to prevent the marketing and administration of the SVF procedures without FDA approval. Prior to the filing of these actions, both companies received warning letters from the FDA. The letters also addressed the results of inspections and the need to resolve significant deviations from manufacturing practice requirements.
In reaching the decision, Judge Ungaro went through the following analysis:
Does the “same surgical procedure exception” apply;
If not, is the HCT/P considered a Section 361 HCT/P;
If not, then the HCT/P is a Section 351 HCT/P and subject to regulation as a “drug”.
In the end, Judge Ungaro concluded that SVF is a Section 351 HCT/P and granted an injunction. In order to obtain the injunction, the FDA had to demonstrate a “reasonable likelihood of further violations in the future.” Judge Ungaro found that the FDA had met its burden and cited to continuous violations and the refusal to bring the practice into conformity.
This judgment represents a significant win for the FDA. The FDA will continue to try to strike the right balance between preventing harm to the public and fostering innovation of new treatments. As for the California case, it is still ongoing. It will be interesting to see if the California case reaches the same result.
This is perhaps one of the largest changes to previous rounds of the Competitive Bidding Program. A DME provider is to bid only on the lead item HCPCS code, submitting the lowest acceptable reimbursement in which they will be able to furnish such lead item supplies under the Competitive Bidding Program. The lead item bid amount, in turn then drives the reimbursement rate for each non-lead item HCPCS code in that supply category. Non-lead items are not separately bid upon.
For example: the lead item for CPAP related equipment is the CPAP device itself, HCPCS code E0601. A DME supplier looking to participate in Competitive Bidding for CPAP devices and related equipment would only bid on the CPAP device (E06001); that bid amount, in turn, would then determine the reimbursement for the non-lead items in the CPAP equipment category, such as masks, cushions, and filters.
There is a great ‘bid calculator’ tool put out by leading industry associations that have banded together to educate suppliers, which allows prospective bidders to see exactly how the lead item supply bid amount directly effects and corresponds with the non-lead item supplies reimbursement.
6. Timely register for access to the CMS online bidding system so that all requested information and documentation can be uploaded, and successfully submit one or more bids.
Latest Competitive Bidding Timeline from CMS
Registration window opens for the DMEPOS Bidding System, DBidS, and Connexion, the program’s secure portal
Expert Florida medical attorneys can safeguard consumers’ interests against any medical malpractice or any other form of frauds committed by a healthcare specialist. However, like any other law, even this is often misused owing to false claims. Hence, it is prudent for a medical practitioner to avail the help of a lawyer who can advise and guide you against such frauds.
Florida Healthcare Law Firm is a reputed healthcare law firm that specializes in Florida Medicare fraudcases, amongst other healthcare guidance. With a team of competent medical attorneys, comprising over 150 years of combined experience under our belt, we pride ourselves in being transparent and being utterly dedicated to the needs of the client.
The team focuses on all kinds of healthcare law and guides the clients into following commendable healthcare practice. It also provides legal assistance in Florida medicare appeal in case of any legal dispute between the establishment and the patients. The team of expert medicare fraud attorneys of our firm are always up-to-date with the complex and ever-evolving fraud laws and how they can be abused via false claims.
To safeguard the client against any medicare fraud, our firm conducts regular Internal Investigations and encourages Self-Disclosures. It reviews Financial Relationships with Physicians and rules on compensation arrangements made to consumers and patients of any kind. The able attorneys are well-read on the complex business structures of healthcare organizations and are capable of providing legal advice on the same.
Connect with the most experienced healthcare lawyers, today!
In layman terms, Intellectual Property law Florida is a set of rules that protects creative or artistic works, inventions, designs and so on. These laws are in existence to safeguard interests of inventors of intangible properties. The intangible properties are formally known as “Intellectual Property” and include anything from copyrights to trademarks to patents.
While there is a general consensus between the rules guarding Intellectual property, the exact details from country to country, or in other cases, state to state might vary. Hence, it is always advisable to consult legal personnel who have extensive experience in the area before filing for a patent or trademark.
Florida Healthcare Law Firm has a team of competent lawyers with 150 years of combined experience under their belt, many of them specializing in intellectual property law Florida. These experts work with utmost transparency and are also completely dedicated to their clients. Our team of experts provide legal guidance on intellectual property law related to the healthcare industry that include patents, copyrights and trademarks of different healthcare services and equipment. Understanding the legalities involved in any of these processes is imperative to conduct a business without any legal hassles. Protecting your intellectual property is the first step to conducting an ethical and sound business or service.
Apart from these, there are other types of Intellectual Properties as well that are protected by our intellectual property attorney Florida. Intellectual Properties of these kinds often give rise to conflicts among individuals and organizations due to their considerable value. Choose the best to protect your Intellectual Property, today!