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
In today’s practices there are many circumstances that call for the discarding of unused portion of drugs, and because of this drug waste can be a big-money issue for many practices. A perfect example is Botox which must be used within five hours of reconstitution, and if it is not used within that timeframe the only option a provider has is to discard the unused supply. What many providers may not be aware of though is that money can be recouped for drugs that have been discarded. The aim of this article is to educate providers that when applicable they may report drug waste in addition to the drug and its administration for Medicare Part B claim reimbursement.
How to Properly Report
For a provider to recoup and report the drug waste they must report the administered drug using the appropriate HCPCS Level II supply code, and the correct number of units in box24D of the CMS-1500 form. As a second line-item providers will want to enter all of the wasted units. It is very important to ensure that the provider documentation verifies the exact dosage of the drug injected, and the exact amount of and any reason for waste. Be aware If the provider did not assume the cost of the drug or administer the drug to the patient they may not bill for the unused portion.
In addition to listing the wasted units as a second line-item certain local contractors may require you to use the modifier JW Drug amount discarded/not administered to any patient to identify an unused drug from single-use vials or single-use packages that are appropriately discarded. Be aware that is inappropriate to use the modifier JW with an unlisted drug code. Therefore, it is imperative to be aware of the local contractor requirements, and appropriate drug codes. 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
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. 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
Pursuant to Section 456.44(3)(a), Florida Statutes, and Rule 64B-9.013(3)(a), Florida Administrative Code, a practitioner must evaluate a patient by taking a complete medical history and performing a physical examination prior to prescribing a controlled substance to a patient. The aforementioned statute and rule do not specifically rule out a patient evaluation taking place via a telemedicine visit. However, under current Florida law, only controlled substances used to treat psychiatric disorders may be prescribed using telemedicine technology, that is audio and video technology commonly referred to as telepsychiatry. Specifically, Rule 64B8-9.0141(4) states, “controlled substances shall not be prescribed through the use of telemedicine except for the treatment of psychiatric disorders.” Psychiatric disorders include Substance Use Disorders since the DSM-V classifies addiction as a mental health condition. Although the Standards for Telemedicine Practice under Rule 64B-9.0141, Florida Administrative Code, allows licensed practitioners to prescribe controlled substances for psychiatric disorders via telehealth technology, the federal law has lagged somewhat behind. read more
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. read more
President Trump has stated that one of his greatest priorities is to reduce the price of prescription drugs. Alex Azar II, secretary of the Department of Health and Human Services (“HHS”), believes that while the United States’ system enabled it to become a world leader in the development of cutting edge drugs is also one that has not prioritized the needs of its own citizens.
On May 11, 2018 Trump directed his Administration to fix the injustice of high drug prices to ensure they come down, and unveiled his “blueprint” to put “American Patients First” though a 44 page document released on HHS’ website.
Pharmacy Benefit Managers (PBMs), previously largely unknown ‘middlemen’ in the U.S. pharmaceutical industry, whose impact on our healthcare system is just slowly beginning to emerge from the shadows, have been taking a lot of flak from independent pharmacy owners, politicians, and the media for being a cause of the high drug costs that the Trump Administration has vowed will be reduced.
A new law has been passed in Florida that pertains to prescribing and dispensing controlled substances. On March 19, 2018 Governor Scott signed HB21, which becomes effective July 1, 2018. Intended to address the growing nationwide opioid epidemic that has also greatly affected Floridians, among other requirements, the new regulations establish: read more