By MICHAEL R. LOWE, Esq.
In 2018, the top health story capturing the news headlines was the opioid crisis. These headlines encapsulated the pulse of the nation with regard to the opioid epidemic. In direct reaction to the opioid crisis and its effect on Florida's citizens, the Florida Legislature adopted HB 21.
Fraser Cobbe's November 2018 Orlando Medical News article, "What Physicians Need to Know Concerning Pain Management Clinic Exemption Applications?" is a pertinent insight into what is now required for Pain Management Clinic exemptions by the Florida Department of Health to combat the opioid crisis through legislation passed in 2018, HB 21. Building on that article, this article further addresses the impact of both HB 21 and the opioid crisis on Central Florida's health care community.
As noted by Mr. Cobbe, HB 21 imposes a number of requirements on health care practitioners who prescribe or dispense controlled substances. The new law, which took effect on July 1, 2018, limits prescriptions for acute pain and holds those prescribing opioids more accountable. Moreover, HB 21 requires clinics that were previously exempt from the requirement to register under Section 458.3265, Florida Statues, also known as the Florida Pain Management Clinic Act (the "Act"), to now obtain and maintain a certificate of exemption from the Florida Department of Health (the "DOH"). Those provisions took effect January 1, 2019.
HB 21 is a direct result of the opioid crisis and the government's action to combat the opioid epidemic. Based on HB 21's changes to Section 458.3265, Florida Statutes, the reason a physician will have to worry about this Pain Management Clinic Certificate of Exemption is if their practice meets the definition of a Pain Management Clinic. Here is the basic and pertinent statutory framework and definition:
Under Florida Law, a pain management clinic is any facility (public or private) that: (i) advertises for any type of pain-management services; or (ii) where in any month a majority of patients are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic, non-malignant pain.
In reviewing that definition, it is important to note that the two (2) separate grounds for qualifying as a "pain-management clinic" are disjunctive and not conjunctive, meaning that if the Practice met either of those two (2) grounds, the DOH would take the position that the Practice is a pain-management clinic under the Act, thereby requiring it to register as a clinic with the DOH. With regard to the definition regarding advertising in any medium for any type of pain-management services, it is important to note that the term "medium" although not defined in the Act, would be interpreted broadly by the DOH and/or the Board. In our experience, our firm would anticipate that the DOH and/or the Board would interpret the language "any medium" to include radio, television, brochure, internet/website, telephone books, on-line listings, LinkedIn listings, billboard, email solicitation, business cards, and other similar materials and mediums.
In reviewing the definition's second basis for determining whether a practice or entity is a "pain-management clinic" your prescribing practices and statistical information are critical pieces of information that must be analyzed in further depth to determine whether your practice or entity meets the definition of a "pain-management clinic" under the Act. Specifically, you must focus on whether in any given month you prescribed opioids, benzodiazepines, barbiturates, or carisoprodol to the majority of your patients for the treatment of chronic nonmalignant pain. Notably, the term "majority" is not defined in the Act, and therefore, the DOH would likely interpret that term in a general, common-sense approach, meaning that if you prescribe those pain-management medications to more than fifty percent (50%) of your practice's patients in any given month for the treatment of chronic nonmalignant pain, then you would be prescribing those medications to a majority of your practice's patients. Simply stated, the DOH would use a fifty percent (50%) threshold when interpreting the term "majority" in determining whether the Practice meets the definition of a "pain-management clinic".
Consequently, it is critical for you to keep pertinent information and data regarding your patient demographic, prescribing practices, pain management prescriptions, and the number of patients for whom you prescribe one of the four medications listed in the Act for patients with chronic, nonmalignant pain if you are in anyway trying to determine whether your practice, entity or facility meets the definition of a "pain management clinic" under the Act.
If you do not meet that definition above, then you do not have to worry about the Pain Management Clinic Certificate of Exemption requirement. However, if you determine you do meet this definition, then you must register as a Pain Management Clinic or claim one of the Exemptions by completing the Certificate of Exemption.
Failure to comply with the registration or Certificate of Exemption requirements in the Act can result in severe penalties including, but not limited to, disciplinary action being taken against the medical doctor's or other licensed health care professional's Florida license, investigation by the DOJ and/or the Florida Attorney General's office for failure to comply with a statute which carries with it potential criminal implications and penalties, fines, and/or collateral actions being taken by 3rd-party payors including the federal Medicare program and/or medical staff and peer review entities for hospitals and ambulatory surgical centers where physicians and health care professionals may perform pain management care and treatment. Consequently, it is imperative that you carefully analyze the Act's provisions and how they may apply to your practice, and if you have any doubts or confusion, then to contact qualified health care legal counsel for further advice and guidance.
Additionally, and equally applicable and important to Central Florida's health care community is the fact that in August 2017, the U.S. Attorney General announced the formation of the Opioid Fraud and Abuse Detection Unit, a new Department of Justice pilot program that utilizes data to identify and prosecute individuals who are contributing to the prescription opioid epidemic. The pilot also funds 12 experienced Assistant U.S. Attorneys in opioid "hot-spots" for a three-year term to focus solely on investigating and prosecuting health care fraud related to prescription opioids. According to the U.S. Department of Justice, former Attorney General Jeff Sessions, these "hot-spots" are Central Florida, East Tennessee, Southern West Virginia, Western Pennsylvania, Southern Ohio, Eastern Michigan, Northern Alabama, Nevada, Eastern Kentucky, Maryland, Central North Carolina and Eastern California.
As one of the 12 "hot-spots" that will be focused on for the 3-year term by the DOJ, Central Florida health care providers need to be aware and cognizant of this increased focus and scrutiny that will be applied to the Central Florida area, and in doing so should ensure that they take all possible steps to maintain prescribing, medical record keeping, pain management clinic and billing/claims submission compliance in their daily practices of treating pain management patients or patients with chronic or even acute pain. A health care provider or professional does not need to necessarily meet the definition of a "clinic" under the Act to draw scrutiny or enter other attention from the DOJ task force that is monitoring Central Florida. Any potentially untoward or non-compliant prescribing, billing or pain management treatment practices could result in an audit, investigation or even criminal action by a host of Florida or federal government and health care regulatory agencies. Thus, if you are a healthcare provider professional that treats pain management or chronic pain patients, and/or prescribes any type of opioid or narcotic pain medications for patients, it is advisable to conduct a review of your prescribing, record keeping, billing, and treatment practices.
But, perhaps the most significant federal legislative development came late in 2018 when President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. The SUPPORT Act is wide-ranging legislation that touches on almost every aspect of the epidemic including treatment, research, funding, and reporting. Notable provisions of the SUPPORT Act include:
Expanded telehealth coverage and reimbursement for treatment of substance disorders;
Authorization of an alternative payment model demonstration project to increase access to outpatient treatment for Medicare beneficiaries;
Expansion of existing programs and create new programs to prevent substance use disorders and overdoses;
Provision of measures to prevent illicit flow of opioids into the United States by mail; and
Funding to encourage research and development of new non-addictive painkillers and non-opioid drugs and treatments.
What does all of this mean for you? The key takeaways are the following:
- Know the definition of a "pain management clinic" under Florida law and whether or not your clinic meets the definition or is exempt and must file for a Certificate of Exemption.
- Be careful with your prescribing practices and habits.
- Always have a written pain management contract with your patients.
- Be vigilant with tracking your prescribed numbers each month. If you are audited or investigated, you will need backup to show the % of patients prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic, non-malignant pain.
- Telemedicine - use it in your practice if applicable, but ensure you have the required licenses and permits to engage in a telemedicine practice.
- Make sure you understand how to properly bill 3rd party payors for pain management and substance abuse care and treatment.
- Back up information and control data securely.
As with any overview, this information is general and intended to help you make informed decisions. The Healthcare Law Team at Lowe and Evander, P.A. understand the hard work and sacrifices it takes to become a health professional or provider and aggressively defend health professionals regarding protecting their license, practice, career, assets and reputation. Using our experience and expertise, we navigate the obstacles our clients face, serving not only as their attorneys, but also as their legal strategists, trusted advisors and protectors of their rights and interest against government investigations and lawsuits when necessary, and we help chart a course through the maze of state and federal health care laws, rules and regulations.
For other healthcare related legal information click here to learn about physician employment agreements.
Michael R. Lowe, Esquire is a board-certified health law attorney at Lowe & Evander, P.A. Mr. Lowe and our law firm regularly represent providers, physicians and other licensed health care professionals, and facilities in a wide variety of health care law matters.
For more information regarding those health care law and such matters please visit our website www.lowehealthlaw.com or call our office at (407) 332-6353.