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.
On August 19, an amendment to the Public Readiness and Emergency Preparedness Act was announced by HHS which allows pharmacists in every state to now administer childhood vaccinations to children ages 3 and older, subject to several requirements,
The vaccine must be approved or licensed by the Food and Drug Administration (FDA).
The vaccination must be ordered and administered according to the CDC’s Advisory Committee on Immunization Practices (ACIP) immunization schedules.
The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
Florida Healthcare Law Firms adds experienced attorney Zach Simpson to the team to assist with pharmacy law, imaging center compliance, as well as chiropractic law, healthcare business development and contract negotiation.
Florida Healthcare Law Firm has announced that they have added Zach Simpson to the team. Zach brings a wealth of healthcare business experience in settings such as private medical practices, large law firms and healthcare management companies. Zach specializes in areas including operations, process, procedures, rules, regulations, management, organization, compliance, analytics, and problem solving. He’s also worked on physician dispensing programs and within numerous medical systems mastering programs like Abbadox, PACS, K-Pacs, Carestream, Merge, and Telax to improve the efficiency of medical centers’ day-to-day activities.
“Now more than ever, healthcare businesses are taking the time to attend to important tasks like processes, policies and procedures. The ones who unfortunately closed during COVID had some ‘downtime’ to focus on what to do better when reopening. Zach’s wide variety of experience in medical offices brings first hand knowledge on how to prepare and how to run things smoothly. As we all have adapted to a ‘new normal,’ Zach is on board to help with business management and development,” Florida Healthcare Law Firm COO Autumn Piccolo says. Founder and President, Jeff Cohen, goes on to say that, “We help you with the business operation side so that you can focus on what you do best, care for patients. Zach’s organizational skills and leadership are a great addition for current and future clients. His analytical and negotiation skills will absolutely benefit healthcare business owners.”
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.
On February 11, 2019, the Hon. Judge John Z. Lee issued an impactful opinion (msj opinion Case 114-cv-05602) in high-stakes class action litigation that has been pending for more than four years, ruling on a Motion for Summary Judgment that the Defendant’s faxed prescription requests were not unsolicited advertisements in violation of the Federal Telephone Consumer Protection Act (“TCPA”).
Here is some background on the case: Over the period of several months in 2013, the Defendant, a DME/pharmacy supplier, sent six prescription requests via facsimile to a doctor for breathing medication on behalf of a patient. Problem was, unbeknownst to the Defendant, the prescription requests were being sent to the wrong doctor.
Pharmacies using automated dialers for prescription refill reminders and relying on the statutory prescription refill reminder exemption to the TCPA’s prohibition on the use of automated dialing equipment as an impenetrable blanket against liability need to think again.
The case of Smith v. Rite Aid Corporation, 2018 WL 5828693 (W.D.N.Y. Nov. 7, 2018), revolves around a Rite Aid pharmacy’s use of a prescription refill reminder program to contact a patient to pick up a prescription. The pharmacy placed several calls per week intended to remind the patient to come into the store to pick up their prescription. However, an innocent bystander instead of the intended recipient of the mediation received the calls; either due to error in taking the phone number down or a due to the number being reassigned (which happens to thousands of numbers on a daily basis!). The unintended recipient of the multiple prescription refill reminder calls filed a class action lawsuit under the federal Telephone Consumer Protection Act (“TCPA”), which provides for statutory penalties of $500-$1,500, per call.
In giving consideration to whether healthcare regulations apply to a proposed course of conduct it’s absolutely vital for a pharmacy to know its payor! This is especially so in the context of patient marketing and the various regulatory prohibitions on paying for healthcare referrals. Unfortunately, some pharmacy owners remain a bit mixed up about who the ultimate payor is for the medications they dispense, and, depending on that pharmacy’s billing operations, such mistakes can have devastating consequences.
A large part of this confusion might be attributed to the fact that in most instances, a pharmacy is not billing the ultimate payor directly (unlike a DMEPOS provider that may be directly submitting claims to Medicare Part B), but rather, the pharmacy is billing an intermediary entity called a Pharmacy Benefit Manager (“PBM”), which is usually a commercially run entity (non-government owned) that manages and adjudicates claims on behalf of health insurance plans that cover pharmacy benefits.
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.