Month: November 2023

Prepared by: Carlos Arce, Esq.

Hot of the press. The jury spoke yesterday, November 8, 2023, in the pending litigation “State Farm Auto. Ins. Co. v. Michael Thomas Larocca, D.C., et al.”, Case Number 8:21-cv-2536-SCB-AEP, the 16 Defendants, which included Chiropractors, Medical Doctors, and Nurse Practitioners were held not guilty of committing fraud, civil conspiracy, unjust enrichment, and violating the Florida’s Unfair and Deceptive Trade Practices Act (FDUTPA). State Farm had filed a claim against the 16 defendants back in 2021, the allegations were the usual elements raised by Special Investigation Units (SIU), non-medically necessary procedures, and engaging in illegal patient brokering and kickback schemes based on the marketing activities performed by the chiropractic clinic.

For years the SIU has brought forth these sorts of allegations and audits against chiropractors, and providers engaged in the person injury space. Yesterday was a big win for those providers. With the passing of HB837 it has been difficult to understand the future of the personal injury protection space and the bodily injury space. Providers are fighting back and are challenging draconian measures passed down by the motor vehicle insurers.

This case shows how lack of compliance with Florida Patient Brokering Act, marketing practices, and referral relationships between providers allows for these payors to bring claims against a medical provider for Fraud, False Claims, and FDUPTA. The only way to fight back without having to do so in court, such as in the Laroccacase, is to meet compliance in your practice.

Another lesson that could be learned from this case is seeking skilled and knowledgeable counsel on these matters. Knowing the laws, the options, the risk and the landscape on how those laws are used are the cornerstone of the required legal representation when dealing with motor vehicle insurance SIU claims.

Many chiropractors and providers who are involved in the personal injury space are undergoing these investigations at this time and will continue to do so as long as motor vehicle accidents are around. Chiropractors and providers should have a few key elements in place when ensuring compliance, policies and procedures surrounding patient intake, billing and coding practices, proper employment and/or independent contractor agreements between the clinic and the providers performing the services, a functional electronic medical records platform, and proper documentation during patient encounters.

Attorney Carlos H. Arce works with the Florida Healthcare Law Firm in Delray Beach, FL. He has deep experience with health law, business law, and mergers & acquisitions. Carlos has handled multi-million-dollar healthcare transactions and has served as out-of-house counsel to various small to large healthcare entities. He can be reached via email at [email protected] or by calling 561-455-7700.

Prepared by: Carlos Arce, Esq.

You’ve seen the ads and you know the jingle, Oh! Oh! Oh! Ozempic. Yes, we are talking about the famous diabetic drugs, Ozempic (semaglutide) and Mounjaro (tirzepatide) (hereinafter “GLP’s”), administered through injections for patients with Type 2 diabetes. However, that’s not how the public views it and that’s not how many health providers have approached its prescriptions. This article focuses on the issues surrounding the prescription risks of these drugs for cash clinics (med spas, regenerative medicine, and concierge medicine), primary care providers who do cash services and take insurance or submit prescriptions which are reimbursed by insurance.

The “Trend”

Healthcare providers have created a spike in the utilization of GLP’s for theirwell-knownoff-label use, weight loss. Pharmacies are experiencing a shortage, insurance companies are experiencing an increase in prescription approvals and reimbursement, and the government has a close eye on the situation. The FDA approvedOzempic back in December of 2017, and Mounjaro in May of 2022. Since then, GLP’s have been in the limelight, and desire from the public has created huge demand. Patients are asking their providers to prescribe these GLP’s in wellness visits with primary care physicians and other patients are paying top dollar cash for “nutritional visits” which include the approval and prescribing of these drugs.

The Insurance Police (“Special Investigation Units”)

The recent article from Becker’s Payer Issues, has released data showing many of the top commercial payors in the United States are waging war against off-label prescriptionsfor these drugs. Payers such as Anthem Blue Cross have sent letters to providers warning them of prescribing GLP’s for off-label use. Language contained in those letters raises False Claims Act territory,“The Special Investigations Unit has completed a comprehensive review of your prescription and professional claims,” a letter to a Missouri physician said. The letter said 60 percent of patients prescribed Ozempic lacked “sufficient evidence” of diabetes and that Anthem would refer “suspected inappropriate or fraudulent activity … to the state licensure board, federal and/or state law enforcement,“; a quote provided by the Washington Post who reviewed a hand full of these letters sent by Anthem.

The Standard of Care (“Compliance”)

The question often comes up from clients who services cash patients whether they need to adhere to the certain regulatory requirements which are more commonly followed in insurance-based practices. The short answer is yes. Cash practices must follow the same regulatory compliance guidelines when treating patients as not only adherence to the law but also for the safety of their patients. Patients are begging their providers for these drugs, and providers aren’t documenting as they should. One of the key ingredients to compliance is having “policies and procedures”. If

[1]Payers Crack Down on Ozempic Prescriptions, Jakob Emerson, June 12, 2023. https://www.beckerspayer.com/payer/payers-crack-down-on-ozempic-prescriptions.html?origin=BHRE&utm_source=BHRE&utm_medium=email&utm_content=newsletter&oly_enc_id=8685H6122145J1S

providers are following the proper methods under the standard of care, they shouldn’t have a problem explaining why they are prescribing certain drugs to patients. If you perform a thorough office visit, and the patient has diabetic symptoms or potential diabetic concerns, is it not reasonable to send said patient for blood work, and if that blood work shows and proves diabetic traits would, GLP’s be considered the proper treatment? The answer is it all depends on what providers in the community deem to be the appropriate level of treatment or care. 

Attorney Carlos H. Arce works with the Florida Healthcare Law Firm in Delray Beach, FL. He has deep experience with health law, business law, and mergers & acquisitions. Carlos has handled multi-million-dollar healthcare transactions and has served as out-of-house counsel to various small to large healthcare entities. He can be reached via email at [email protected] or by calling 561-455-7700.

Compounding

Compounding is the process of combining of two or more drugs. Practitioners in hospitals, clinics, and other health care facilities sometimes provide compounded drugs to patients when an FDA-approved drug is not medically appropriate to treat them.Importantly, compounded drugs have not been approved by the FDA. Quality requirements for compounded drugs differ depending on the setting where compounding occurs. Drugs compounded in outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements. Drugs compounded by a licensed pharmacist in a state-licensed pharmacy, or federal facility, or by a physician, in accordance with the conditions of section 503A of the FD&C Act, are exempt from compliance with CGMP requirements. These facilities may be subject to less stringent quality standards set in state law or policy. Such standards may differ from state to state and therefore is crucial that practitioners understand what quality requirements are applicable to their practices that engage in compounding.

Reconstitution

Reconstitution is the process of adding a liquid diluent to a dry ingredient to make a specific concentration of liquid.In some cases, reconstitution is necessary because a medication doesn’t remain stable long enough to be distributed in solution form, so it comes from the manufacturer in a powdered or crystalized form and must be “reconstituted” with a liquid prior to being administered parenterally by injection. It is crucial to follow the reconstitution instructions from the manufacturer and to maintain a thorough understanding of who can engage in reconstitution and when it is legally appropriate in accordance with state and federal guidelines.

Piggybacking

An IV piggyback, also known as an IVPB or secondary infusion, is a method of administering medication through an intravenous (IV) line. It involves attaching a smaller bag of medication to the primary IV line and allowing it to infuse intermittently. The primary bag contains maintenance fluids or flush, while the secondary bag contains the medication that needs to be administered.

This method is commonly used when multiple medications need to be administered through the same IV line. The use of an IV piggyback can help reduce the risk of infection and minimize the number of needle sticks required for clients who require multiple medications. In other words, piggybacking allows medications to be administered without interruption of the primary IV fluids. When “piggybacking” it is important to ensure that this is done compliantly to avoid increased risk of contamination and infection, as well as negative adverse reactions.

Despite which of these methods are being employed by your practice, certain disclosures are legally required depending upon which practice(s) you may be engaging in. Considering the rapid growth within the IV therapy industry, compliance with administrative and regulatory federal and state law is more crucial than ever so that when governmental enforcement agencies have the opportunity to catch up with the industry, your healthcare businesses are protected from unforeseen enforcement and related fall out.