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.
There have been a rise in cases recently, in which practices that operate under a Health Care Clinic License have been brought under scrutiny by insurance companies trying to recoup funds through any means possible. In an effort to claw back funds insurance companies are beginning to claim that medical directors are failing to meet their statutory obligations under Florida Law which in turn can have serious monetary repercussions. Due to the clinics allegedly failing to meet their statutory obligations the insurance companies are filing suit to recoup any payments made while violating the Health Care Clinic Act obligations, and to stall any future payments due until such cases are heard.
By law, a medical director must be a health care practitioner that holds an active and unencumbered Florida license as a medical physician, osteopathic physician, chiropractic physician, or podiatric physician. The type of services provided at a clinic may dictate who would be able to serve as a clinic’s medical director, because a medical director must be authorized under the law to supervise all services provided at the clinic.
You do everything right. You’re careful to dot your i’s and cross your t’s. Compliance is hard-wired because you’re in an industry that’s highly regulated and you’ve built into your operations a series of compliance checks and balances. However, even with strong controls in place, compliance efforts sometimes fall short– and whether you’re a physician group, a pharmacy, a durable medical equipment company, a home health agency, or any other health care provider, someday you might find yourself face-to-face with law enforcement officials or regulatory enforcement authorities. What do you do? How do you assure the most successful outcome with minimal business disruption?
Compliance is the foundation to mitigating the risks inherent in any health care operation. Compliance can reduce the likelihood that regulators or law enforcement suddenly appear on your doorstep. But preparation for emergencies and uncertainties is the key to reducing the risk that non-compliance leads to lengthy business interruption. Although you may be saying “if”, you really should be thinking and acting more like “when”. It costs everything to be ill-prepared and it costs very little to be well-prepared. The following preparation can prevent much of the uncertainty that arises in these cases.
POLICIES AND PROCEDURES
First and foremost, make sure you have well-developed policies and procedures for what to do in such instances. You should review these policies and procedures with your employees regularly, focusing on the importance of compliance. Out of fear and uncertainty, employees can do things that create unnecessary challenges. Educating them as to what their rights and responsibilities are will mitigate those risks. Make sure your policies and procedures include the designation of who is in charge (“person in charge”) when the government does show up. read more
The Question of the Week: Is your Medical software provider using the Cloud to store data?
These days everyone is migrating to the Cloud. This exodus away from servers to the cloud is driven by the flexibility, security and pricing that Cloud services such as AWS (Amazon Web Services), Microsoft’s Azure, Google Cloud and IBM offer software developers. It is a pretty safe assumption that most healthcare software vendors are currently using the Cloud, or they plan on using the Cloud. read more
A recent Department of Justice $500,000 settlement with a cardiology practice underscores the need for ensuring tighter compliance by medical practices. There, the practice billed Medicare for cardiology procedures for which interpretive reports were also required. Medicare paid for the procedures, but upon audit, CMS could not find the requisite interpretive reports. The False Claims Act case settled for $500,000, but it’s likely that (1) the reimbursement by Medicare was far less, and (b) the legal fees behind the settlement weren’t too far behind the settlement amount! Had the practice self-audited each year, would they have found the discrepancy?
Medical practices have felt the weight of price compression and regulatory load more than probably any segment in the healthcare sector. They are doing far more for far less. And regulations expand faster than viruses! Hence, many have a strategy of regulatory compliance that can best be characterized as a combination of facial compliance (“We bought the manual and put it on the shelf”) and hope (“They’re not really serious about this, are they?”). Unless you’re part of a practice of more than 20 doctors, it’s likely that you can do more to ensure regulatory compliance.
Wanna know how often we’re asked whether the laws re healthcare marketing are really enforced? How often we hear “Everyone is doing it.” “Surely they [regulators] understand that every healthcare business has to market its services and item,” we’re told. And when we start to educate people re the state and federal laws that pertain to marketing healthcare items and services (INCLUDING those for which payment isn’t made by a state or federal healthcare program), their impatience and intolerance is palpable.
Take a look at the latest report from the Department of Justice guilty plea from someone who marketed the services of a genetic testing lab. He admitted being guilty of receiving over $300K in kickback money (presumably in the form of marketing fees) and now faces (1) a $250K fine, (2) returning all the money he received, and (3) five years in prison!
Marketing any healthcare service or item is at the tip of the sword in terms of regulatory investigation and enforcement. It’s that simple. And so when your lawyers drag you through laws like the Anti-Kickback Statute, the Florida Patient Brokering Act, the federal health insurance fraud law, the bona fide employee exception, the personal services arrangement and management contract safe harbor and EKRA, thank them! And expect nothing less. If you do ANYTHING at all in the neighborhood of marketing a healthcare item or services, the first place to start is: meet with a very experienced healthcare lawyer who is not learning on your dime. And have them take a couple hours to educate you about the laws, the options and the risks of each one. And once you’ve done that, ask them what more you can do to reduce your risk, for instance— read more
In another article, we provided an update to the autonomous practice law for Nurse Practitioners in Florida. For NP’s that qualify, that means they can open a primary care practice without a supervising physician. For most, that means learning about opening and operating a company. Here’s what that entails:
Florida is the latest state to expand the practice of Advanced Practice Registered Nurses. In March 2020, autonomous practice was passed and signed into law, with the law going into effect in July. In October, the Board of Nursing promulgated rules and provided the application for NP’s seeking to practice autonomously.
Before qualifying for autonomous practice, however, an NP must meet the following requirements:
DOES YOUR BUSINESS NEED A MANDATORY VACCINE POLICY?
Given the above, does a mandatory vaccine policy make sense for your organization? This may depend on several factors, including the following:
Are your employees in direct contact with clients/customers/patients?
Is that contact prolonged and in indoor spaces where air circulation may be limited?
If one or more of your employees become ill, does that jeopardize continuity of your business?
If you answer “YES” to one or more of these questions, you may want to consider implementing a mandatory flu vaccine.
In order to effectively implement a mandatory vaccination policy, you must develop both the policy and the process to manage exceptions (i.e. requests for accommodations). The process generally involves the submission of an employer-developed form along with any additional supporting documentation. The accommodations process should include review of information submitted by the employee in support of the accommodation, request for additional information as and when appropriate, an interactive process between the employer and employee in evaluating any potential accommodation, and ultimately a determination if the requested accommodation poses an undue burden that is more than de minimis on the employer. read more
Can an employer require employees to be vaccinated against influenza? And, a COVID-19 vaccine likely will be approved in the not-to-distant future. What about that vaccine when it becomes available? These are questions with which many organizations are grappling today. With the confluence of what is expected to be a very active influenza season and the ongoing and unprecedented COVID-19 pandemic, employers are contemplating how best to protect their workforce and clients/customers/patients.
One of the most effective ways to achieve this is a mandatory vaccine policy, but is that right for your organization? Mandatory vaccination programs are not new. Depending on your business, a mandatory vaccine policy may be the industry norm. What factors should you consider? What processes would you need to develop to address exceptions?
CAN YOUR BUSINESS MANDATE VACCINATIONS?
In general the answer is yes. Although federal and state laws may vary, such programs are permissible provided any mandatory vaccination policy incorporates processes to address the required exceptions: medical accommodations under the Americans with Disabilities Act (ADA); and religious accommodations under Title VII of the Civil Rights Act of 1964 (Title VII). read more