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.
FMVs are at the heart of healthcare regulatory compliance when money or anything of value changes hands in a healthcare business setting. Why? Two reasons:
Healthcare laws (Stark, the Anti Kickback Statute and the Patient Brokering Act) all target money changing hands in the healthcare business space; and
There are clear exemptions and exceptions that have as an essential ingredient that the compensation (or pricing) is consistent with “fair market value.”
How it Goes—A Six Part Process
Locking down an externally performed FMV (part of the “gold standard” in regulatory compliance) is a process. Here’s what it should look like:
Step 1. The healthcare business person or his/her advisors (often accountants) find someone who specializes in performing FMVs for the specific matter (e.g. compensation, price of a business to be acquired);
Step 2. The LAWYER for the healthcare business is immediately involved in the process BEFORE the FMV firm is engaged;
Step 3. The LAWYER engages the FMV firm on behalf of the healthcare business client;
Step 4. The parties (including the lawyer) get on the phone or in a meeting with the “FMV guy” and has a very extensive conversation re the project;
Step 5. Once the FMV process done, a DRAFT FMV study is prepared and discussed interactively with the healthcare business and the lawyer;
Step 6. Once finalized, an execution copy is prepared and provided to the lawyer. read more
A 2018 Department of Justice civil settlement involving a Florida interventional pain physician was a cliff hanger when it surfaced, especially vis a vis the issue of the so-called Company Model, where anesthesiologists and referring physicians jointly owned an anesthesia provider. The Daitch settlement involved interventional pain specialists who settled the case for $2.8 Million. There, the government claimed that a mass of urine drug tests weren’t reasonable or medically necessary. But the issue buried in the settlement call the issue of intertwined medical businesses and the Company Model into question.
The so-called Company Model involves the formation of a company that provides anesthesia services. It’s jointly owned by anesthesiologists and referring physicians. Theoretically, on a Monday, the anesthesiologists own the anesthesia practice and bill for all anesthesia services performed at a GI lab or ASC. On a Tuesday, however, the new company (jointly owned by the same anesthesiologists and the referring physicians) steps in and starts billing for the anesthesia services, thus indirectly sharing a part of the profits with the physicians who are generating the anesthesia referrals.
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
Inspired by many medical integration consultants and coaching organizations, chiropractors have vigorously pursued medically integrating their practices in the past handful of years. Led by both the desire to provide effective healthcare solutions and to capture more of the healthcare dollar that their patients are already spending (elsewhere), chiropractors are smart to consider it…slowly!
Too often, there are stories of chiropractors who felt both excited and pushed to sign on the dotted line at integration seminars, only to find later on that (1) the advice they got upset their lawyers, (2) they didn’t understand the complexities and risks that accompanied their practice expansion, and (3) it didn’t work! What are some of the greatest areas of disappointment for those where the integration didn’t go smoothly?
A. Using integration to fix an underlying business problem. For instance, if you’re medically integrating your chiropractic practice because your chiropractic patient volume has fallen off, first try to understand why your core business is down. For instance, do you actively pursue marketing? Is it effective? What about someone inside your organization who is responsible for sales? Do you have someone comfortable offering what you provide and talking money? Since it’s typical for medical integration patients to come from your core chiropractic business, a down chiropractic business will not deliver the patients needed to support a robust medical integration line of services and products; and
The Secretary of Health and Human Services issued blanket waiver of the Stark Law on March 30th in order to facilitate COVID related medical services. The waivers apply only to financial relationships and referrals related to COVID. The circumstances and conditions under which the waivers apply are strictly and narrowly described. Moreover, the waivers have no impact in the presence of fraud or abuse. With respect to physicians wanting to provide designated health services (e.g. clinical lab services) related to COVID detection and treatment, for instance–
the federal requirement that the DHS be provided in the same building as the physician office is waived; and
the financial relationship limitations between the physician (or family member) and the DHS provider is waived.
The waiver also contains specific examples of waived interactions between providers and hospitals, including— read more
COVID is proving to be so burdensome on employers that we are seeing lay-offs and furloughs all over the country. As the virus curve bends back in a positive direction and physician and patient concerns for safety wane, patients will stream back to office. But what happens to the laid off (or furloughed) employees and contractors with non-competes? Will they come back or will they have moved on, possibly in a way that violates their noncompetes? And will a court think a noncompete has been violated when an employee or contractor was let go and there is no specific provision in their written contract that allows the employer to immediately let someone go without notice due to this type of situation? How will the COVID based lay-offs and furlough affect noncompetes? The short answer is we don’t yet know, but widespread lay-offs and furloughs may result in a flood of cases being filed because (1) many have been let go, (2) there likely isn’t a provision in their contract with the employer that specifically authorizes that sort of termination, and (3) a contract’s “breach” (e.g. no contract based allowance for the prompt termination) is traditionally a defense to an action to enforce a noncompete.
The COVID Issue
Though there is an exception for unusual specialties or where there is essentially a community need, noncompetition covenants are generally enforceable in Florida with respect to doctors and other healthcare professionals. Many people think doctors in particular can’t be restricted from practicing medicine under any circumstances. That is just not true.
Getting to the bone of the issue, noncompetes are enforceable in Florida if: read more
Florida’s Governor passed an Executive Order Friday which essentially shuts down all elective medical treatment. The Order (20-72) only allows “non-urgent or non-emergency procedure or surgery which, if delayed, does not place a patient’s immediate health, safety, or wellbeing at risk, or will, if delayed, not contribute to the worsening of a serious or life-threatening medical condition.” read more
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— 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