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.
If you are facing ahealthcare regulatory compliance audit make sure that you are well represented by an experienced attorney. These matters are nothing to be overly worried about but it’s always a good idea to make sure you have all your bases covered. Working with a team of lawyers is the best way to ensure you get a favorable outcome while eliminating frustration and headache. Running a medical business isn’t easy as there are more rules and regulations you have to follow than with other businesses. However, that doesn’t mean you have to do it alone as you will get the support you need from the best legal team in Florida.
At Florida Health Care Law Firm we have worked with clients in all areas of the medical field and handled many cases involving healthcare regulatory compliance audit and more. When you work with our team, you will have the full support of our services. That means if you have questions regarding opening a treatment center, implementing policies and procedures, selling or buying a business or anything else, you will have the full support of our team. Visit us today to learn more and meet with a lawyer who can assist you.
A healthcare regulatory compliance audit is not something you want to take lightly. While you may not have done anything wrong, the fact is that your business is about to be put under review and that needs to be taken seriously. When this happens, you need to ask yourself these questions:
Where can I get facts? One of the things we all continue to do is to go online and check out websites and blogs to get “facts.” These sites don’t provide real facts because even if the information is correct, it may not apply to us. That’s why you need to speak with an attorney who can get you the right information you need in order to make the best possible decisions.
Do I need an attorney? Going into an audit, you may or may not need the help of a lawyer. It’s difficult to say but one thing is for certain, you should speak with a lawyer before the meeting to know whether or not you will need one as well as to get legal advice that can help you during the case.
What about other issues? Once completed you do not want this matter to become a recurring one. That’s why it’s always smart to work with a legal team that can assist you in these matters as well as others. Whether you are opening up a call center, selling a practice, hiring a new physician or anything else, it’s a matter of convenience and peace of mind that you are able to get real help when you need it.
At the Florida Health Care Law Firm our team is standing by to assist you with any healthcare regulatory compliance audit matters you may need assistance with. Be sure to call us today for more information and find out what your legal options are.
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
Laboratories nationwide are overwhelmed with increased diagnostic testing volume while simultaneously managing regulatory changes in light of the COVID-19 pandemic. It is more essential than ever for clinical laboratories to enforce regulation, have a compliance plan in place and develop or enhance operational policies. Our firm has expert lab lawyers with ‘insider’ healthcare business knowledge to help keep your business compliant while adapting to the rapidly changing healthcare landscape.
Download the laboratory compliance image as a PDF here.
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.
Home health agencies everywhere have become the favorite targeted acquisitions of “the financial world.” Apparently, there is one seminar that every buyer attended convincing buyers or all kinds (buyers with money, buyers without money, buyers in the private equity space) that:
HHAs are ripe for aggregation because the industry is disaggregated; and
HHA owners lack business sophistication necessary to bring their businesses to the “next level.”
Unfortunately, some of the buyers lack any true industry experience and are looking at acquisition targets solely from a financial perspective. They’re looking principally at business financials and nothing else. And, worse yet, they’re not focused on the centrality of operational expertise. All of which can come crushing down on the head of seller financed acquisitions. In other words, if the buyer is paying the purchase price over time, the seller is effectively financing the transaction because the purchase proceeds are (in theory) coming from seller operational profits. This may make the transaction possible, but operations will ensure company profitability and growth, which is gonna drive seller interest.
So what? A lot! As current HHA owners know, the secret sauce is in not financial analytics. It’s in the operations! And the financial due diligence is just a part of the equation. What about regulatory due diligence? What about knowing where the bodies are buried (legally speaking)? What are the payer relationships? What are the marketing relationships? What is really driving the business? Who is the key reason why the HHA is successful? It is typically one or two people. And missing that or retiring them is a recipe for disaster for buyers and seller financed sellers. As is missing illegal payments made to induce patient referrals, which can shut down even a completed transaction in a heartbeat. None of this is part of the usual [financial] due diligence!
Lawyers might say “Yeah, but there will be plenty or reps and warranties to cover the transaction. And the indemnification sections will be tight.” So what? The buyer doesn’t want a pig in a poke. They want a reliable and growing income stream. Details matter. Especially the details both buyers and sellers are missing!
Further, if a buyer thinks they can buy an HHA on the cheap (1) without proper due diligence, (2) with lawyers waiting to get paid if the transaction closes and funds, and (3) with heavy seller financing, think again. If you’re dealing with a buyer with pockets (or you have pockets) and will spend the right money on proper due diligence, the right (and experienced) marketing and management, have at it! The HHA industry is ripe for aggregation. But doing it in “the new way” isn’t new at all. It’s just defective and a recipe for lots of heartache…and litigation.
Real buyers love due diligence. They love to measure twice (three times is even better!) and cut once. They love either understanding the business they’re buying or buying the operational talent. And they understand and embrace the notion of putting hard money to work. They don’t try to buy something for nothing or find lawyers who don’t have enough work to do who are willing to work for free. Real buyers are not trying to get something for nothing. And they don’t allow a financial flow focus to blind them to the daily “wax on; wax off” aspects of the business. Doing so would disappoint both sellers and buyer investors.
It’s great to see so much activity in the HHA space. But the ones that win and stay will only be the ones that do it the old fashioned away—They’ll Earn It!
The 340B Discount Drug Program allows manufacturers participating in Medicaid to agree to provide outpatient drugs to certain designated clinics and hospitals at significantly reduced prices. The typical discount ranges from 30% to 50% off the drug’s list price. In turn those clinics/hospitals are able to reach more high-risk, high-need patients and provide more comprehensive services. Each designated clinic/hospital involved in the program is called a “covered entity.”
Covered entities may provide drugs purchased through the 340B Discount Drug Program to all eligible patients of that covered entity, regardless of a patient’s payer status. In order to be a “patient” of a specific covered entity, an individual (1) must have an established relationship with the covered entity such that the covered entity maintains records of the individual’s care; and (2) must receive care from a professional employed by or contracted with the covered entity such that responsibility for the care remains with the covered entity. Under the guidelines, an individual is not considered a patient of the covered entity if the individual only is dispensed a drug for the patient to take at home. read more
Three family members involved in owning an addiction treatment center and/or a toxicology lab were charged in July with patient brokering and money laundering in an alleged scheme involving roughly $2 Million. The allegations arise out of a complex corporate enterprise involving at least four companies and some common ownership between the treatment center and lab. While it’s premature to assume that the defendants did anything illegal, there are some interesting things in this case:
Complexity Invites Suspicion. Every business owner in the addiction treatment and toxicology lab space knows three things: (1) it’s extremely regulated, (2) law enforcement has an especially sharpened focus on these industries, and (3) insurance companies are very suspect of any situation involving either industry, especially when there is any common ownership. So why then would one construct an enterprise that even “looks” complex or tricky? It intensifies suspicion in an already highly scrutinized business space. This is clearly one of the points of focus in this case. There’s an old saying woven into the mind of every experienced healthcare lawyer: if something can’t be done directly, it can’t be done indirectly. Time will tell if anything in this case was wrong or if there are any good reasons for the corporate structure, but the complexity of the corporate structure certainly invites suspicion. read more
Florida may become the “next Texas” on the issue of physician owned specialty hospitals. “Next Texas,” since there are a number of examples where the concept launched (and also flopped). Done right, such facilities could be a better fit for many patients, depending of course on patient co morbidity issues. In theory, they would be the perfect bridge between surgery centers and regular acute care hospitals. But the ability of such specialty focused care suggests a better staffing model and more targeted and efficient overhead, instead of the broad-based overhead of an acute care hospital at is spread out aver all cases, including those where overhead allocation is viewed as “just an expense.” read more
Those in the practice of dentistry today have many options when it comes to building a practice. Should you work for an employer? Build your own? What about buy a practice? More and more, we see young dentists wishing to avoid private equity and buying out a retiring dentist’s practice. The amount of regulation imposed upon those entering into the dental practice arena can be staggering. Further, buying a dental practice requires many considerations that are unique to other areas of business. Understanding the purchase process will help protect your investment and could keep you from experiencing any unnecessary liability.
First, organize a team of specialized dental experts, such as a dental CPA, Professional Practice Lender, dental law attorney, and a practice consultant. Having a team of professionals guide you through all aspects of the deal will keep you on track, avoid potential issues, accomplish specific task items, and properly comply with any legal considerations. read more
On February 4, 2020, the Department of Justice announced a $1.5 million settlement with Southeastern Retina Associates, a 17 physician practice, with offices in Tennessee, Georgia and Virginia. The sole basis of the claim was the alleged misuse of the Modifier 25 billing code and charging for exams at higher levels than warranted. The claim was initiated by a whistleblower, who will receive $270,000 from the settlement.
Use and potential abuse of Modifier 25 is obviously not unique to retina surgeons. In fact, the modifier can be very beneficial to providers, since it allows for payment for those patient visits when the care provided exceeds the scope of the scheduled appointment. However, given the potential for abuse and the many watchful eyes of the government (the Southeastern Retina case was investigated by the U.S. Attorney’s Office, the HHS Office of Inspector General, the U.S. Office of Personnel Management, the FBI, and the Tennessee Attorney General’s Office) and wannabe whistleblowers, a periodic review of a provider’s billing practices is always a good idea. read more
On November 15, 2019 Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring hospitals to publicly disclose “standard charges, including payer-specific negotiated rates for items and services. Hospitals will be required to comply by January 1, 2021. The proposed rule is subject to 60 days of comment.
The final rule requires hospitals to make public in a machine-readable file online all standard charges (including gross charges, discounted cash prices, payer-specific negotiated charges) for all hospital items and services. It requires hospitals to de-identify minimum and maximum negotiated charges for at least 300 “shoppable” services. read more