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.
I am a successful physician who works for a thriving practice that is affiliated with a local hospital or Ambulatory Surgical Center (“ASC”). The hospital/ASC was so impressed with my professionalism and skills that they retained me to perform certain additional duties and services for them. Of course, they are paying me for my time and services. This is great, I love my work, I am generating two sources of respectable income – all is good.
Not so fast!
As can sometimes be the case, all is good while there is smooth sailing and while the money is coming in. However, once there is a bump in the road, a hiccup in a procedure, or a third party employee files a complaint with the Equal Employment Opportunity Commission (“EEOC”); the Florida Commission on Human Relations (“FCHR”); Department of Labor (“DOL”) or any federal or state agency complaining about some alleged incident in their workplace. Their filing of a lawsuit can be against you individually, against your practice or against the hospital/ASC. Not to mention, a lawsuit can be filed by a patient or third party against the practice or the hospital/ASC. Then what? 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
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. read more
Private money (e.g. private equity) is in full swing purchasing medical practices with large profit margins (e.g. dermatology). This is NOT the same thing as when physician practice management companies (PPMCs) bought practices the 90s. Back then, the stimulus for the seller was (a) uncertainty re practice profits in the future, and (b) the stock price. Selling practices got some or all of the purchase price in stock, with the hopes the purchasing company stock would far exceed the multiplier applied to practice “earnings” (the “multiple”). Buyers promised to stabilize and even enhance revenues with better management and better payer contracting. If the optimism of the acquiring company and selling doctors was on target, everyone won because the large stock price made money for both the buyer and seller. The private equity “play” today is a little different.
Today’s sellers are approaching the private equity opportunity the same way they did with PPMCs, except for the stock focus since most private equity purchases don’t involve selling doctors obtaining stock. Sellers hope their current practice earnings will equate to a large “purchase price.” And they hope the buyer have better front and back office management that will result in more stable and even enhanced earnings. And for this, the private equity buyer takes a “management fee,” which they typically promise (though not in writing) to offset with enhanced practice earnings. read more
In giving consideration to whether healthcare regulations apply to a proposed course of conduct it’s absolutely vital for a pharmacy to know its payor! This is especially so in the context of patient marketing and the various regulatory prohibitions on paying for healthcare referrals. Unfortunately, some pharmacy owners remain a bit mixed up about who the ultimate payor is for the medications they dispense, and, depending on that pharmacy’s billing operations, such mistakes can have devastating consequences.
A large part of this confusion might be attributed to the fact that in most instances, a pharmacy is not billing the ultimate payor directly (unlike a DMEPOS provider that may be directly submitting claims to Medicare Part B), but rather, the pharmacy is billing an intermediary entity called a Pharmacy Benefit Manager (“PBM”), which is usually a commercially run entity (non-government owned) that manages and adjudicates claims on behalf of health insurance plans that cover pharmacy benefits. read more
Platelet-Rich Plasma (“PRP”) has become a popular treatment for various conditions from sports injuries to hair rejuvenation so it makes sense that PRP regulation must keep up. With PRP, both the device used to separate platelets and the subsequent use of the PRP product fall under the scope of the U.S. Food and Drug Administration (“FDA”). The common question is: what is approved by the FDA with regards to PRP? Given the increased use, it is important for health care providers to understand the FDA’s standpoint on PRP regulation.
Medical Device Regulation
Let’s start with PRP devices. Generally, the FDA provides several avenues in which a device, drug, or biologic can come to market. For medical devices, an applicant can either obtain Premarket Approval (“PMA”) or 510(k) clearance. Most PRP preparation systems have utilized the 510(k) clearance process. What is meant by 510(k) clearance? The 510(k) application process, also known as premarket notification (“PMN”), is for medical devices that are seen as lower risk which are found to be “substantially equivalent” to a previously cleared device. Under the Food, Drug and Cosmetic Act, device manufacturers are required to register and notify the FDA of the intent to market a medical device in advance.
The FDA then determines whether the device is equivalent to a device already on the market. The 510(k) clearance process is a common way for PRP devices because it is less costly and time consuming as opposed to obtaining PMA. There is one important caveat though with 510(k) clearance. Clearance does not equate to approval for treatment of any indication. It only applies to its intended use in a specific setting. For example, in past warning letters issued by the FDA, the agency has required certain manufacturers to add language to its label stating that the PRP prepared by the device had not been evaluated for any clinical indication. read more
The need for healthcare services is growing at an exponential rate throughout the US and across the world while the number of healthcare providers is dwindling in comparison which paves the perfect way for telemedicine. The ease of healthcare access should be standard for all people, but many go without healthcare because of their geographic location or lack of funds. From these circumstances, technology has risen as the new champion for the provision of healthcare; technology is building necessary connections between healthcare providers and patients through telemedicine. The field of telemedicine complements traditional medical care in various ways already, and it is expected to continue to expand through the healthcare industry. Some current uses are as follows: read more
When considering optimization of healthcare business operations it is important to remember Limited Liability Companies are fundamentally just partnerships with added liability protection. The LLC structure offers liability protection called charging order protection, which prevents your (or your partners’) personal creditors from seizing your business or its assets to settle personal debts. Since LLCs were designed to be partnerships, you are expected to adhere to some basic partnership rules – most importantly, you should have partners. Running an LLC with no partners opens you up to liability. read more