On March 4, 2020, the Centers for Medicare & Medicaid Services (CMS) issued three Quality, Safety & Oversight Memoranda, all concerning the Coronavirus. According to these documents, effective immediately, the government will begin to focus its inspections exclusively on issues related to infection control and other serious health and safety threats. According to CMS Administrator Seema Verma, the memoranda should be seen as a “call to action across the healthcare system.” The goal of the guidance given in the memoranda is to continue to keep Americans safe and prevent the spread of the Coronavirus.
The first memorandum resets the focus of governmental surveys. The order of priority for government surveys will now be:
Miami resident Adrian Abramovich certainly wasn’t laughing on Thursday May 10th, 2018 when the Federal Communications Commission (“FCC”) levied a $120 MILLION dollar fine on him for his alleged involvement in an illegal robodialing campaign. FCC Chairman Ajit Pai stated that Abramovich did not dispute that he had placed more than 96 million telemarketing robocalls over a three month period in 2016 without the recipient’s consent. Furthermore, Chairman Pai stated that Abramovich’s telemarketing campaign utilized caller ID “spoofing” which masks the calling party’s true phone number and causes the recipient’s caller ID to indicate that the call was being made by a local number. Abramovich’s telemarketing activities allegedly violated a variety of state and federal regulations; caller ID spoofing, for example, is expressly prohibited by the Florida Telemarketing Act, § 501.616(7).
With the record-breaking fine imposed on Abramovich, the FCC is sending a loud and clear message that it will not tolerate those individuals or entities that violate telemarketing laws. Any person or business engaged in telemarketing (be it a healthcare provider with a single telephonic sales representative or a business devoted to telemarketing with a 100 person call center) must heed the FCC’s unsubtle hint that enforcement activity of telemarketing laws is only heating up.
The U.S. Food and Drug Administration (FDA) has issued new guidance for regenerative medicine manufacturers and healthcare providers. At the core of the guidance are two central interpretations: 1) the FDA’s current interpretation of the minimal manipulation and homologous use criteria set forth in 21 CFR Part 1271; and 2) the FDA’s current view on the same surgical procedure exception under 21 CFR 1271.15(b). Additionally, the FDA issued a notice to all interested stakeholders that the FDA intends to initiate increased discretionary enforcement over the next 36 months for human cell and tissue-based products. Given these developments, healthcare companies and providers impacted by this guidance are strongly encouraged to ensure compliance with the FDA’s new interpretations.
Healthcare regulatory compliance is too damn complicated sounding and scary! What the heck does it even mean? Basically it means making sure you’re following about a dozen specific laws, some of which interrelate. It’s a little like making a cake. You have to make sure you have flour, eggs, sugar and so on. And then you have to make sure you put enough in the bowl and bake it at the right temperature. So what’s so unique re healthcare regulatory compliance? Healthcare professionals and businesses are inundated by these confusing laws written in legalese, to the point where they go numb. They lose the ability to focus on them and to take them seriously. And they hire someone that uses the word “consultant” or “compliance”; and they think they’ve got compliance covered. But they don’t. And that’s a big mistake in the healthcare world!
The Board of Medicine and Board of Osteopathic Medicine Joint Committee on Medical Marijuana (the “Committee”) have started the journey to developing rules pursuant to the Medical Marijuana Use Act, Senate Bill 8A, Chapter 2017-232, Laws of Florida, Section 381.986, Florida Statutes). The Committee’s first conference was held July 14, 2017, with a follow-up conference being held August 3rd. A third conference is scheduled for August 25th during the Board of Osteopathic Medicine’s monthly meeting.
Doctors often consider the idea of clinical research to be an easy “add on” to their practices. The usual idea is “I already have the patients. This’ll be easy.” But that’s not the case when you start to look at the healthcare regulatory compliance issues!
Pharmaceutical companies (“Sponsors”) are often looking for resources for clinical research. They usually turn to clinical research organizations (CROs) to find research centers (Sites) and to manage some of the healthcare regulatory compliance issues in a way that creates enough distance between the Sponsor and the Site in hopes that the metrics from the patients enrolled in the study will provide clarity re the efficacy of a tested drug.
Medical practices that think it’ll be easy to become a Site will be very surprised by some of the key challenges, which include–
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.