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.
With phenomenal growth and expansion in the Hemp Industry comes trials, tribulations, the FDA, and consumer complaints! Let’s take a look at what’s going on that might have an adverse impact on your burgeoning business or foray into Hemp a/k/a CBD.
The FDA sent letters to 15 CBD business companies in late November 2019, warning and admonishing these companies that their CBD products were being promoted to treat disease or for having certain therapeutic properties. Specifically, the FDA reviewed these companies’ websites, social media pages, marketing material, etc., finding that the companies promoted products containing cannabidiol or CBD in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Further, the FDA stated that the companies’ CBD products are unapproved new drugs sold in violation of the FD&C Act, and were misbranded under the FD&C Act. The FDA letters did not just target products sold for human use and consumption, but also targeted CBD products sold for use on pets, stating that “the products are unapproved new animal drugs that are unsafe under the FD&C Act and adulterated products under the FD&C Act. read more
The Office of Civil Rights within the U.S. Department of Health and Human Services recently imposed $2,154,000 in civil money penalties against Jackson Health System in Miami, Florida for multiple violations of HIPAA. The majority of the penalties were due to violations of the HIPAA Security and Breach Notification Rules, rather than for the actual breaches of confidentiality. This action by the government underscores the importance of complying with all of HIPAA, and not just the requirements to safeguard Protected Health Information. read more
With the legalization of medical marijuana, I could not help but think, could a medical marijuana practice be the next “pill mill” and how could that be possible with the strict requirements set forth in Section 381.986, Florida Statutes. Turns out, only a handful of physicians are prescribing the majority of medical marijuana. While this may at first blush indicate a problem, keep in mind that marijuana, even medical marijuana is still outlawed under federal law and many physicians are not willing to risk a DEA license or possibly a state license to become a physician that certifies a patient for using medical marijuana. If a physician does become a qualified physician and issues medical marijuana certifications, certain practices and behaviors should be avoided.
A Practice with Similarities to a Pill Mill
In May 2019, Department of Health filed an administrative complaint against a “qualified physician” for basically over-certifying the use of medical marijuana. Pursuant to Section 381.986, there are only 13 medical conditions for which medical marijuana may be recommended. Of those 13 medical conditions, one is a bit of a “catch-all” as it is for medical conditions of the same kind or class as or comparable to a list of ten specific conditions, i.e., cancer, epilepsy, glaucoma, positive status for HIV, AIDS, PTSD, ALS, Crohn’s disease, Parkinson’s disease, and MS. This is where the physician ran into a problem. read more
On November 15, 2019 Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring hospitals to publicly disclose “standard charges, including payer-specific negotiated rates for items and services. Hospitals will be required to comply by January 1, 2021. The proposed rule is subject to 60 days of comment.
The final rule requires hospitals to make public in a machine-readable file online all standard charges (including gross charges, discounted cash prices, payer-specific negotiated charges) for all hospital items and services. It requires hospitals to de-identify minimum and maximum negotiated charges for at least 300 “shoppable” services. read more
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