The core aspect of EKRA has to do with how to properly compensate marketing personnel who market the services of labs, addiction treatment facilities and recovery homes. For those of you already familiar with existing federal law pertaining to compensation arrangements (e.g. the bona fide employee exception (the “BFE”) and the personal services arrangement and management contract safe harbor (the “PSA”)), the EKRA provisions will look familiar! Key aspects of this law (which has to be read together with similar existing laws) include—
Pursuant to Section 456.44(3)(a), Florida Statutes, and Rule 64B-9.013(3)(a), Florida Administrative Code, a practitioner must evaluate a patient by taking a complete medical history and performing a physical examination prior to prescribing a controlled substance to a patient. The aforementioned statute and rule do not specifically rule out a patient evaluation taking place via a telemedicine visit. However, under current Florida law, only controlled substances used to treat psychiatric disorders may be prescribed using telemedicine technology, that is audio and video technology commonly referred to as telepsychiatry. Specifically, Rule 64B8-9.0141(4) states, “controlled substances shall not be prescribed through the use of telemedicine except for the treatment of psychiatric disorders.” Psychiatric disorders include Substance Use Disorders since the DSM-V classifies addiction as a mental health condition. Although the Standards for Telemedicine Practice under Rule 64B-9.0141, Florida Administrative Code, allows licensed practitioners to prescribe controlled substances for psychiatric disorders via telehealth technology, the federal law has lagged somewhat behind.
Improving patient outcomes while maintaining physician decision making and practice efficiency is key to success in the growing health care arena. Innovation is the ability to see change as an opportunity to create new value, instead of a threat to what we find comfortable. It is clear that the Center for Medicare and Medicaid Services (CMS) is embracing the importance of innovation in the way we deliver health care.
In November 2018, the 2019 Physician Fee Schedule and Quality Payment Program was released by CMS with changes effective January 1, 2019. This is the time for providers to definitely keep their eyes open to utilizing mHealth, and telehealth services. mHealth is also known as mobile health, and is a general term for the use of mobile phones and other wireless technology in medical care to educate consumers about preventive healthcare services as well as for disease surveillance, chronic disease management, treatment support, epidemic outbreak tracking. The release of the program is a sign that the agency is in favor of expanding the implementation of technology in providing medical care. The updated mHealth codes are:
You might have recently received a holiday gift of a direct-to-consumer genetic testing kit from Ancestry.com or 23andMe.com (or any other number of companies). So exciting! In our melting pot society, one can’t help but be curious about where they come from and if they are more likely than any other person to be subject to any number of ailments.
Not so fast though! Before you swab yourself and send away your genes for testing, you might consider what you’re exposing yourself to. Direct-to-consumer genetic testing companies, which provide genetic testing directly to consumers without any intervening healthcare provider, are not bound by HIPAA. They are not considered “covered entities”, and therefore not required to use the same protections for genetic information the way a hospital or your doctor would.
Pharmacies using automated dialers for prescription refill reminders and relying on the statutory prescription refill reminder exemption to the TCPA’s prohibition on the use of automated dialing equipment as an impenetrable blanket against liability need to think again.
The case of Smith v. Rite Aid Corporation, 2018 WL 5828693 (W.D.N.Y. Nov. 7, 2018), revolves around a Rite Aid pharmacy’s use of a prescription refill reminder program to contact a patient to pick up a prescription. The pharmacy placed several calls per week intended to remind the patient to come into the store to pick up their prescription. However, an innocent bystander instead of the intended recipient of the mediation received the calls; either due to error in taking the phone number down or a due to the number being reassigned (which happens to thousands of numbers on a daily basis!). The unintended recipient of the multiple prescription refill reminder calls filed a class action lawsuit under the federal Telephone Consumer Protection Act (“TCPA”), which provides for statutory penalties of $500-$1,500, per call.
Over the past few years, it seems like physician employment agreements are getting shorter and shorter. While I applaud all efforts towards efficiency and economy, you should not always take those documents at face value. For example, I recently reviewed a one page employment contract for a client. That single page basically said, “We are hiring you as our employee for a term of one year, with an annual salary of $$$.”
At first glance, the simplicity of that document might seem refreshing. That’s especially true if you’re worried about how much time it’s going to take for your lawyer to get through it! My client’s second glance revealed a multitude of unanswered (and essential) questions. There was no mention of expected duties, schedules, standards, renewals, terminations, insurance, benefits, vacation time, sick leave, CME, etc. in the employment contract However, when we reviewed the contract together, we discovered that although those points were not even referenced on that single page, they were still legally, “in there.”
On November 29, 2018, Florida Representative Chuck Clemons proposed house bill 65 (“HB 65”) that would significantly tighten regulation on the use of stem cells. If the stem cell bill is signed into law, Florida will join other states (e.g. California, Texas and Washington) in passing some type of stem cell regulation. While some bills around the country have centered the regulation on informing prospective customers of the risks associated with these treatments, HB 65 takes a more stringent approach with the threat of criminal exposure and includes certain protections for providers in the form of a “right-to-try” law.
On November 1, 2018, a federal court judge in the U.S. District Court for the District of Columbia granted a motion for summary judgment in favor of the American Hospital Association (AHA) ordering the U.S. Department of Health and Human Services (HHS) to clear the Medicare appeal backlog by fiscal year (FY) 2022. If you have not been following this litigation, the AHA initially filed suit in 2014 against the Secretary of the U.S. Department of Health and Human Services (HHS) requesting an order from the court mandating the Office of Medicare Hearings and Appeals (OMHA) within HHS to comply with its statutory deadlines (i.e. to issue a decision within 90 days). Following brief review by the U.S. Court of Appeals and upon the case being before the district court for a third time, the case has finally reached a resolution.
In short, HHS agreed that due to recent funding, compliance is possible within four years. Accordingly, the judge set the following deadlines for HHS and OMHA:
There are perfectly compliant ways to engage with healthcare marketers, and then there’s this; here are some of the latest real-life examples:
“DME BRACE CAMPAIGN – $40 to $150 PER LEAD PER BRACE”
“DME DIABETIC LEADS $40 PER LEAD, INSURANCE AND DOC INFO INCLUDED”
“PAIN CREAM/LIDOCANE LEADS FOR SALE, RX INCLUDED”
These marketers are seemingly holding auctions for the sale of federally protected patient health information out to the highest bidder! Couldn’t make this stuff up – if you’re in this industry, a quick gander at your (business) social media platforms will quickly confirm it.
Regulatory compliance is a mandatory investment for any healthcare business owner looking to stay out of serious and personal legal peril, let alone one hoping to keep their company viable.
Yet there is seemingly an onslaught of providers that blatantly run afoul of many of these regulations, knowingly or not, or those that believe they may have found a loophole.
Concerning the latter, there is an important mantra that such DME and pharmacy providers should remember and live by: “[W]hat a provider cannot do directly, it cannot do indirectly through an intermediary.”
Marketing for DME – What exactly am I talking about?
DME providers enrolled with CMS (should) know they cannot solicit or ‘cold call’ Medicare Part B beneficiaries, per the Federal Anti-Solicitation Statute, and that they cannot offer anything of value to a potential patient that could induce them to utilize them as a provider, in accordance with the Beneficiary Inducement Statute.
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.