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.
COVID is front and center in all aspects of everyday life and has shined light in the strangest of places that were usually in the dark. In healthcare the laboratory space has always taken a backseat to other sectors in terms of recognition and value. The current climate in the lab space has shifted and it is not an illusion, labs are front and center.
COVID has taken its toll on areas of the economy and investors are certainly one of the first to become aware of this situation. Clinical laboratories are currently an attractive acquisition target and the reasons are numerous, sectors like retail, entertainment and travel are performing poorly and investors are shifting their investment dollars into healthcare and technology. Investors are looking for growth and profitability and are finding it in healthcare. Mergers and Acquisitions (M&A) is nothing new in the lab industry, but now careful consideration is required when it comes to deciding the appropriate time to sell your lab.
The Office of Inspector General (OIG) and other Federal agencies charged with responsibility for enforcement of Federal law have emphasized the importance of voluntarily developed and implemented compliance plans. The government, especially the OIG, has a zero- tolerance policy towards fraud and abuse and uses its extensive statutory authority to reduce fraud in Medicare and other federally funded health care programs. The OIG believes that through a partnership with the private sector, significant reductions in fraud and abuse can be accomplished. Compliance plans offer a vehicle to achieve that goal. The OIG has provided a model compliance plan for clinical laboratories to assist laboratory providers in crafting and refining their own compliance plans.
The OIG suggests that the comprehensive compliance program should include the following elements:
Laboratory buyers and sellers considering a sale or purchase should have knowledge of issues that can affect the transaction. Due diligence requires conducting measures that provide a buyer confidence that the laboratory for sale is being accurately represented by the seller.
The transaction requires consideration, communication and planning between all parties and their representatives. A thorough knowledge of laboratory compliance and rules and regulations is imperative as documentation and information that is provided and reviewed will more than likely change the pricing, value and terms of the deal.
Due diligence is required in any healthcare transaction and is performed so that both the buyer and seller fully understand the transaction. An effective and necessary tool regarding laboratory transactions is a due diligence checklist. The checklist will allow both sides to identify and address issues that may be neglected or overlooked. The categories that compromise a laboratory checklist should include, but are not limited to: 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
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
Effective July 1, 2018, Florida’s recent legislation SB 622 repeals the entirety of Chapter 483, Part I of the Florida statutes, and removes the state licensure requirement for clinical laboratories operating in-state and out-of-state. Section 97 of SB 622, approved by the Governor on March 19, 2018, repeals the entirety of Chapter 483, Part I of the Florida statutes, and so eliminates section 59A-7.024(1). read more
A recent whistleblower action (by UnitedHealthcare Medical Director, Tina Groat) against Boston Heart (laboratory) was brought under the federal False Claims Act and deals with medical necessity issues. As part of the analysis, the Court reviewed whether a laboratory [or supplier like DME] must determine the medical necessity of the ordering physician. Boston Heart contended that a doctor, not a laboratory, determines the medical necessity of a test. Boston Heart argued that when a laboratory bills Medicare for testing ordered by a physician, it must only maintain documentation it receives from the ordering physician and ensure that the information that it submitted with the claim accurately reflects the information it received from the ordering physician. It noted that the CMS-1500 form certification does not require that the billing lab to make the medical necessity determination. The lab certifies that the services are medically necessary by relying on the clinical determination of the treating physician. read more
One of the biggest challenges faced by addiction treatment providers today, especially in Palm Beach County, Florida, arises in the context of unprecedented pressure by law enforcement via the Sober Home Task Force, newspapers and insurers. The threat of being targeted by law enforcement is an enormous thing in itself. Add to that the mainstream media’s insatiable desire for readers, the industry’s drop into insurer red flagging and recoupment, the political football nature of addiction and addiction treatment, and treatment providers can lapse into a state of paralyzed tunnel vision, a sort of mass hypnosis. Here’s the problem: providers dealing with the current compliance crisis environment have a lot to lose if they take their eye off the bigger picture. The more absorbed they become in “crisis mode,” the more likely they will miss important addiction treatment compliance details in an increasingly regulated and changing industry. Losing the ability to see the entire picture (and trends) and quickly adapting to it can have costly (and even deadly) consequences.
The addiction treatment industry is like any other healthcare provider—enormously and increasingly regulated, highly scrutinized and always dynamic. The moment it took on features of traditional healthcare (e.g. lab and physician services), it left the relatively warm and fuzzy comfort of behavioral health providers, sorta. “Sorta” because medical behavioral health (e.g. psychology and counseling) has not had it easy in the past 10 years, as it came under crushing price compression with managed care driven networks and other price cutting middlemen that have often been owned or controlled by insurance companies. Addiction treatment providers in the pure behavioral health space were “saved” from all this till about three years ago because they were out of network and not the focus of insurer driven price cuts. As payors (and their price cut incentivized middle men) looked for more ways to drive up profits, the competitive and disorganized addiction treatment sector became a natural (and unprepared) sector to hit. And they hit it hard! Clearly, the Perfect Storm. Addiction treatment providers now have no option but to learn to swim hard and fast in the ever changing river of the healthcare business industry. read more
Most of the commercial payors are paying PHP (Partial Hospitalization Plan) and IOP (Intensive Treatment Plan) at a bundled daily rate. Many of the plans are now adding urine drug screens to the bundled daily rate and imposing a cap on the number of screens that can be done during an admission. Plans are paying rates that are much nearer to a Medicare rates. Payments based on a reasonable percentage of a provider’s charge are becoming harder to find, as the calculation of what is a usual and customary rate of payment continues to decline.
Yet, a great portion of substance abuse facilities are operating with more clinical staff, at a higher level through licensure, with better Electronic Medical Systems, more programs to combat some of the symptoms of addiction and with a greater awareness of compliance with state and federal guidelines. Even with these necessary improvements, reimbursements continue to decline. read more
Cigna recently sued a Texas hospital, Humble Surgical for overpayments. Humble Surgical is an out-of-network (OON) provider. Cigna alleged fraudulent billing practices and that the hospital engaged in a scheme to defraud payors by waiving members’ financial responsibility.
While the suit involved many other allegations our article focuses on the arguments Cigna made on failure to collect co-payments, deductibles, and co-insurance and fee-forgiving practices by the hospital. There were several other issues raised that are important to various practices that Cigna has engaged in with out-of-network providers. Cigna has consistently audited South Florida providers alleging failure to collect patient financial responsibility or fee-forgiveness, then informing the provider that it was not entitled to any reimbursement because these practices fell within the exclusionary language of the member’s plan.
The suit brought under federal law, ERISA and also Texas common law seeking reimbursement for all overpayments. Cigna was seeking equitable relief including imposing a lien or constructive trust on fees paid to the hospital.
Humble Surgical counter sued against Cigna for nonpayment of patients’ claims, underpayment of certain claims and delayed payment of all claims in violation of ERISA, including other causes of action. Here’s what happened: read more