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.
Yet again, the fraud enforcement arm of the DOJ strikes out against fraud in the pharmacy industry. Two new cases shed continuing light on the ongoing fraud.
Announced last week by the DOJ, the owner/operator of five pharmacies in New York pled guilty to charges stemming from a scheme to defraud Medicare and Medicaid by billing for prescription drugs that were not dispensed, not prescribed, not medically necessary or dispensed when the pharmacy had no authority to dispense the prescription drugs. This blatant disregard for the law was magnified when the owner/operator used the ill-gotten gains of her scheme to purchase luxury items like cars and jewelry. Nothing screams “come and get me” like openly flaunting the money taken from the government. read more
This individual spearheaded a scheme involving kickbacks to marketers and prescribers to defraud TRICARE and other healthcare programs by submitting claims for unnecessary compounded medications, which also involved routine waiver of patient financial responsibility. read more
Pharmacies and their pharmacists are in a very tough spot in the current regulatory enforcement environment. This is particularly true with dispensing controlled substances. Headlines like the below are commonplace:
DEA RAIDS PHARMACY AS PART OF LOCAL DRUG SWEEP
PHARMACY PAYS $500,000 IN PENALTIES FOR CONTROLLED SUBSTANCES ACT VIOLATIONS
MAN ARRESTED USING DOCTOR’S PRESCRIPTION PAD TO WRITE FRAUDULENT RX’S
So, how do you avoid filling a fraudulent prescription for controlled substances? Before getting into the nitty gritty, it is important to lay the foundation of standard of care and the corresponding responsibility so pharmacies and pharmacists can evaluate what steps are most likely to mitigate these risks.
As background, federal law states that the primary responsibility for prescribing controlled substances rests with the prescriber. However, that same law places a “corresponding responsibility” on the pharmacist to assure each prescription is written for a legitimate medical purpose pursuant to a valid patient-prescriber relationship. 21 CFR §1306.04(a).
Under Florida law:
A pharmacist may not dispense a Schedule II-IV controlled substance to any patient or patient’s agent without first determining, in the exercise of her or his professional judgment, that the prescription is valid. F.S. §893.04 (2)(a).
A prescriber or dispenser must consult the prescription drug monitoring system, eForce, to review a patient’s controlled substance dispensing history before prescribing or dispensing a controlled substance.S. §893.055
Once you have a clear understanding of a pharmacist’s liability, you can then consider ways to mitigate the inherent risks in filling controlled substance prescriptions. read more
On March 31, 2020 the Florida Division of Workers’ Compensation (DWC) clarified that physicians are permitted to dispense medications to injured workers, and that an injured worker shall have full and free choice to utilize their physician for medication dispensing, as well as any other pharmacy or pharmacist.
It was declared by the DWC that it is not appropriate for employers/carriers to deny authorization or reimbursement for prescription medication solely because the medication is dispensed by the treating physician who is a licensed Florida dispensing practitioner instead of a pharmacist.
What Led to the DWC Bulletin?
A Florida dispensing practitioner was denied reimbursement for drugs dispensed out of their office to an injured worker in a recent reimbursement dispute claim. The physician asserted the claims administrator denied reimbursement for the dispensed medications because the physician was not authorized to dispense prescription medications. The Florida Department of Financial Services (DFS) ruled in favor of the physician – DFS Case No.: 20180824-007-WC – and subsequently issued DWC Bulletin DWC-01-2020 on March 31, 2020.
In my last post, I promised to keep you updated as to any new orders from the State Surgeon General that would further extend a practitioner’s ability to prescribe refills of non-malignant pain controlled substances using telehealth communications, or a qualified physician’s ability to recertify an existing qualified patient’s use of medical marijuana. The Surgeon General has extended the ability to continue assisting patients with these specific needs (as well as other needs) until May 31, 2020, through the issuance of Emergency Order 20-007 on May 9, 2020.
Keep in mind, that to prescribe a refill of a controlled substance for chronic non-malignant pain, the practitioner must be an MD, DO, APRN, or PA licensed in Florida and designated as a controlled substance prescribing practitioner. Further, to prescribe such controlled substances using telehealth communications during this public health emergency, the patient must be an existing patient of the prescribing practitioner. read more
Like many entrepreneurial endeavors, owning a pharmacy requires careful planning and an astute risk versus reward analysis. However, unlike other industries, venturing into a healthcare business brings with it an entire new world of regulations, and rightly so. Pharmacies don’t sell widgets they sell prescription drugs, and to people whose well-being depends on it being done correctly. As such, there’s a host of state and federal laws a pharmacy must abide by, intended to safeguard patients and the healthcare system as a whole. Don’t let regulatory hurdles alone serve as an insurmountable deterrent from entering into what can be a profitable and fulfilling profession; proactive compliance is the key to success! Here’s an overview of the general steps necessary to become a pharmacy owner, be it from scratch or by acquiring an existing practice. For the purposes of this article, let’s assume it’s a community/retail pharmacy that will be located in Florida.
So what’s better – building from scratch or buying something that’s already out there? Typical lawyer answer – it depends! But I won’t stop there; here are some considerations that must be taken into account to make a proper decision: (1) how quickly does the business need to be up and running? It’s typically a faster process to commence business by acquiring an existing pharmacy rather than buying one, but that depends on (2) what is out there in the current marketplace? If a stock acquisition, all of the known and unknown liabilities will be inherited by the new owner; proper due diligence on the pharmacy’s past is essential. read more
The need for healthcare services is growing at an exponential rate throughout the US and across the world while the number of healthcare providers is dwindling in comparison which paves the perfect way for telemedicine. The ease of healthcare access should be standard for all people, but many go without healthcare because of their geographic location or lack of funds. From these circumstances, technology has risen as the new champion for the provision of healthcare; technology is building necessary connections between healthcare providers and patients through telemedicine. The field of telemedicine complements traditional medical care in various ways already, and it is expected to continue to expand through the healthcare industry. Some current uses are as follows: read more
It is becoming easier and easier for physicians to communicate with each other and their patients. And although open communication is generally thought of as positive, the medical profession should proceed with caution. Patients and consulting physicians rely heavily on their communications with their treating physicians. Thus, communications which do not require the thought of focus that a physician would otherwise give to a situation may result in disaster. While there are many potential ways a physician might use text messaging and social media both professionally and personally, we will focus generally on physician interactions with other physicians, and physician interactions with patients.
To start, physicians should be aware that, in 2011, the American Medical Association issued guidelines in its Code of Ethics for physicians who use social media: read more
Many health policy experts are betting on the expanded role of telemedicine as an essential cost-saving, quality (and access) enhancing tool. Yet legal and policy issues have dogged the development of useful telemedicine guidelines, making it difficult to know what’s ok and what’s not. What sort of licensure is required for physicians practicing telemedicine? When is the physician “practicing medicine” vs. “merely consulting?” When is a physician patient relationship established? Is one even necessary? The newly developed model policy developed by the Federation of State Medical Boards should help guide states in developing specific telemedicine standards.
A trial underway in West Palm Beach will have serious impact on hormone replacement therapy (HRT) businesses around the state. HRT businesses are exploding around the state and country. The underbelly of the business exists where business owners do not approach it as a medical service deserving of the same seriousness (clinically and legally) as any other healthcare service. Four of the doctors involved have already pled guilty to conspiracy charges and were placed on five years probation. One of the doctors relinquished his license.
The allegations involved in the case shed light on some of the more nefarious aspects of HRT business, which in this instance include— read more