The Department of Justice Antitrust Division has advised several pharmaceutical companies that they can share competitive information regarding the status of their respective efforts to develop a COVID-19 treatment without running afoul of the federal antitrust laws. Specifically, in a letter issued on July 23, the Antitrust Division stated that it had no intention to challenge a proposal by … Continue Reading
Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an Anti-Kickback Statute lawsuit brought by a whistleblower pursuant to the False Claims Act’s (FCA) qui tam provision, Novartis, a pharmaceutical company based in East Hanover, New Jersey, has agreed to … Continue Reading
Florida has been contemplating ways to increase patient access to care, especially in light of the COVID-19 pandemic and the anticipated increase in cases. Recognizing the accessibility of pharmacies, Florida is now authorizing certain qualified pharmacists to perform testing, screening, and treatment of nonchronic diseases and specific treatment of certain chronic conditions.… Continue Reading
Pharmacists can now engage in a new role in the battle against COVID-19 – testing patients for the virus. Recognizing the advanced health care training that pharmacists receive and the unique consumer access to community pharmacies during the Pandemic, the Florida Department of Health has designated pharmacists as medical professionals authorized to order and provide COVID-19 tests. Additionally, pharmacies, as … Continue Reading
Just like the dose makes the poison, the claim makes the drug.
With a pandemic well underway, some marketers are offering products that they claim will treat or prevent COVID-19, the disease caused by the novel coronavirus. Without federal approval, however, anyone making claims about unapproved drugs risks is inviting a federal enforcement action. As a result, marketers should exercise … Continue Reading
The catchphrase of the day is “social distancing” and it is the primary means of flattening the COVID-19 pandemic (the “Pandemic”) curve by keeping contagious and healthy people apart. However, there is another kind of distancing that may play a role in fighting the Pandemic – “health care distancing.” Health care distancing is a mechanism to keep the sick patients, … Continue Reading
California has joined the growing ranks of states, as well as the federal government, in efforts to facilitate the efficient provision of healthcare services during the pandemic. Accordingly, in response to federal agency updates with respect to relaxations to existing requirements related to telehealth services, California’s Governor Gavin Newsom issued an Executive Order No. 43-20 on April 3, 2020 (the … Continue Reading
North Carolina has drastically expanded its telehealth services during the COVID-19 pandemic in order to give individuals increased access to remote care. The following article outlines many of the important changes implemented.
As with other states, in response to the COVID-19 pandemic and the guidance that the federal government has issued (see here), Governor Abbott of Texas issued a disaster declaration on March 13, 2020 (the Disaster Declaration) resulting in the loosening of certain existing telemedicine and telehealth related requirements in Texas.
For current license holders, the Texas … Continue Reading
In an effort to preserve healthcare resources (e.g., personal protective equipment), limit potential contact with infected individuals, and free up healthcare practitioners to assist with those suffering from COVID-19, elective healthcare services must cease. Specifically, on March 20, 2020, Florida Governor Ron DeSantis issued Executive Order 20-72 (available here), requiring all Florida licensed healthcare practitioners to immediately cease performing … Continue Reading
In response to the public health emergency declared in Florida on March 1, 2020, Florida loosened existing licensure and other telehealth requirements in response to the COVID-19 pandemic, as outlined below.
However, unless specifically waived or relaxed by the Orders (as defined below), all current minimum practice requirements and standards of care for telehealth services set forth under F.S.A. §456.47 … Continue Reading
Like many other states, in response to the COVID-19 pandemic and the guidance that the federal government has issued, Governor Pritzker of Illinois issued an executive order (2020-09) on March 19, 2020, amending and relaxing existing telehealth related requirements under 225 ILCS 60/49.5 regarding: (1) telemedicine services provided by licensed Illinois physicians; (2) telemedicine and telepsychiatry services provided to Illinois … Continue Reading
Like many states, Florida requires consultant pharmacists to conduct on-site monthly visits to the facilities to which they provide pharmacy services. The visits are required for Modified Class IIB Pharmacy Permits, Special ALF Pharmacy Permits, and Special ESRD Pharmacy Permits. Because of the COVID-19 pandemic, consultant pharmacists—particularly those visiting assisted living facilities—were concerned about off-site consultant pharmacists going from facility … Continue Reading
Unsurprisingly, COVID-19 has created a great degree of liberalization in the telehealth requirements previously in place. What has not changed is the fact that telehealth services are governed by a number of different laws and regulations, all of which are constantly changing – now more than ever. In addition to the multiple changes at the federal level, what follows is … Continue Reading
At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a mechanism to reduce prescription drug prices.
First, at the federal level, as a result of the President’s interest, in June 2018, DHHS Secretary Azar … Continue Reading
International export pharmacies took another step forward towards a separate, distinct licensure in Florida as the Florida Board of Pharmacy held a specially called Rules Sub-Committee Meeting on June 27, 2019, to address the Board’s responsibilities under House Bill 19, which went into effect on July 1, 2019. Section 465.0157, FS, establishes an “international export pharmacy” permit as part of … Continue Reading
Governor Desantis recently signed House Bill 831, which will require certain healthcare practitioners to “electronically transmit prescriptions”. Unfortunately, the legislature left this term undefined, creating some ambiguity as to what the law requires. While the legislature likely intended this law to require “electronic prescribing,” the statute does not say that, and therefore the term “electronically transmit prescriptions” could also … Continue Reading
With an overwhelming amount of bi-partisan support, on May 7, 2019, Georgia enacted the Pharmacy Anti-Steering and Transparency Act, O.C.G.A. §26-4-119 (the GA Act). The GA Act goes into effect as of January 1, 2020.
As healthcare providers are well aware, prohibitions against self-referrals are not new – federal and state laws prohibiting self-referrals by physicians and other healthcare … Continue Reading
We are all familiar with prescription drug television commercials where it sounds like they hired a professional auctioneer to recite the drug side effects so fast you can hardly understand them. The U.S. Department of Health and Human Services (HHS) announced a proposed rule that would require pharmaceutical companies that advertise their prescription drug products on television to also disclose … Continue Reading
Two pieces of related legislation that would prohibit so called “gag clauses” in contracts between pharmacists and health plans and pharmacy benefit managers (PBM’s) have been passed by both the Senate and the House. The legislation prohibits any restrictions on the ability of pharmacists to alert consumers to situations where it may be less expensive for them to pay for … Continue Reading
In a memorandum issued by the Centers for Medicare and Medicaid Management (“CMS”) on August 29, 2018, the federal government outlined new ‘flexibility’ and tools for Part D plans to “expand choices and lower drug prices for patients.” Beginning in 2020, Part D plans will be able to utilize what is called ‘indication-based formulary design’ to change their drug formularies … Continue Reading
In December of 2017, CVS Health and Aetna announced their intention to merge. The transaction, if approved by regulators, would combine the country’s second largest pharmacy benefit manager (PBM), Caremark – a CVS subsidiary – and the nation’s third largest commercial health insurer, Aetna, and has been valued at $69 billion. Since the announcement, federal and state regulators have been … Continue Reading
The Florida legislature passed HB 21, which imposes a number of new requirements on prescribers and pharmacists regarding controlled substance prescribing and dispensing. Part of the law requires pharmacists to verify the identity of the person named on the prescription. These requirements do not apply in an institutional setting or to a long-term care facility, including assisted living facilities or … Continue Reading
Walgreens and Kroger have filed an antitrust action in the United States District Court for the Eastern District of Pennsylvania accusing Johnson & Johnson (J&J) of engaging in anticompetitive conduct designed to stymie the growth of biosimilar alternatives to J&J’s Remicade, a biologic drug used to treat certain chronic immune disorders (Walgreen Co. v. Johnson & Johnson, Case … Continue Reading