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.
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. read more
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. read more
In 2014, the Centers for Medicare and Medicaid Services (CMS) started a program that combined the process of reviewing a sample of claims with providing follow up education as a way to help reduce errors in the claim submission process. This is called the Targeted Probe and Educate Program (TPE). The goal of the program is to help providers and suppliers identify errors made and quickly make improvements. CMS has acknowledged that since its inception the program needs improvements and that this type of review can be burdensome. Most providers and suppliers never experience a TPE review; however, for the ones that receive notification, here are the top five things you should know before moving forward:
Monday, April 29, 2019, the Florida House and Senate came to agreement on a new Telehealth bill (HB 23). If signed by Governor DeSantis, the bill will become effective July 1, 2019.
The bill creates two new statutes: Section 456.47 and Section 627.42396, and amends Section 641.31.
Section 456.47 sets forth the standards of practice for telehealth providers, authorizes the use of telehealth encounters for patient evaluations, and allows certain providers to prescribe certain controlled substances in limited circumstances. The bill also allows non-physician providers to use telehealth without being deemed to be practicing medicine without a license. Further, the bill sets forth record keeping requirements and registration for out-of-state telehealth providers. It authorizes the Department of Health to establish rules for telehealth, including exemptions from registration requirements, and to set up disciplinary action against telehealth providers that violate the law or rules. read more
In 2018, theGlobal Wellness Institute (GWI) released its report “Build Well to Live Well” on the global and regional wellness lifestyle real estate and communities market. The report highlighted various emerging real estate wellness living concepts that will drive future development, and create a surge in the $134 Billion dollar industry, expected through 2022, to reach $180 billion.
The lines between home, work and leisure are less defined. Your neighbor can be your patient, your coach or your nutritionist. The millennial generation and others are focused on living where their needs for healthy and long life are considered. Many people are willing to pay out of pocket for services that contribute to their health and wellness. Medical industry groups and health services will have to catalyze in order to build these wellness communities. These communities will be created by combining medical industry companies and research organizations, high quality hospitals and health services for consumers, and holistically designed wellness focused homes and neighborhoods. read more
With the 2021 competitive bidding round on the horizon for durable medical equipment (DME) providers, both those that are established as well as those fairly new to the industry must take note of the potential pitfalls that may be encountered when competing to become a Medicare contract supplier.
The durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program was first established by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Under this program, DMEPOS suppliers submit bids (i.e. applications) and compete to furnish specific items in competitive bidding areas commonly referred to as CBAs. Additionally, suppliers are not just bidding for the rights to a particular CBA but also for a single payment amount that will replace the current Medicare fee schedule payment. The payment will be determined by using the bids submitted. As of December 31, 2018, all contacts have expired. As a result, there is currently a temporary gap period. The upcoming bidding process is loaded with requirements. Therefore, compliance with each requirement is crucial. Here are a few pitfalls to watch out for: read more
CMS contractors such as Unified Program Integrity Contractors (UPICs) are tasked with ensuring that Medicare pays the right amount for covered services by legitimate providers. Specifically, a UPIC’s main goal is to identify cases of suspected fraud, waste and abuse, and additionally, to take immediate administrative action to protect federal program funds. Within its administrative action toolkit, apart from the common pre- or post-payment reviews and payment suspensions, UPICs have the ability to refer cases of potential fraud to law enforcement agencies. read more
Most everyone knows that laws are being implementing in federal and state government to address the opioid crisis in the US. One such law is the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”) signed into law in October 2018 by President Trump. While the SUPPORT Act seeks to increase access to treatment for substance use disorders and prevention of substance use disorders, it also contains language to prevent abuse of the process to increase treatment access. Specifically, incorporated into the SUPPORT Act is the Eliminating Kickbacks in Recovery Act (“EKRA”) which directly targets unlawful referrals to recovery homes, clinical treatment facilities, and laboratories.
EKRA is similar to prohibited kickbacks and patient brokering pursuant to Sections 456.054 and 817.505, Florida Statutes, using similar language as both Florida statutes. EKRA makes it unlawful… read more
Not tomorrow, but relatively soon. And with a vengeance! We knew the current Competitive Bidding Program moratorium wouldn’t last forever, and that the floodgates that opened as of the first of this year would eventually be reined in.
Indeed, on March 7, 2019 the Centers for Medicare and Medicaid Services (“CMS”) announced a new round of Competitive Bidding, which will commence on January 1, 2021 and last through December 31, 2023.
The largest changes from previous rounds of Competitive Bidding that immediately stand out are: read more
As reported in various media, on January 24, 2019 a trucker got into some hot water when he and his big rig were passing through Idaho en route to California from Oregon. In going through a weigh station and having his cargo inspected, state police didn’t take to kindly to what he was transporting.
His haul? Almost 7,000 pounds of hemp.
His customer? A company that intended to wholesale that crop to businesses that manufacture hemp-derived CBD.
Why the fuss? Drug sniffing dogs alerted to his cargo, and field tests indicated the presence (not concentration) of THC. The trucker was immediately apprehended, spent four days in jail, and was freed after posting $100,000 bond.
The company that hired the trucker to transport the product maintains that the load was indeed hemp, that the amount of THC in the hemp was within permissible federal limits, and that it was improperly confiscated. They want it back! So much so, that they’re suing for it; they filed a lawsuit against both the police and the prosecutor. read more