Pharmaceuticals and Biologics

On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for his role in a kickback scheme. The sentencing follows a plea agreement by Mr. Bojorquez in which he pleaded guilty to conspiracy to violate the federal anti-kickback statute. According to the DOJ and court documents, Mr. Bojorquez, through his company, provided marketing services to various compounding pharmacies. Mr. Bojorquez’s company conspired with the compounding pharmacies to pay kickbacks to physicians in exchange for those physicians referring prescriptions to the compounding pharmacies. The compounding pharmacies then paid Mr. Bojorquez (through various shell companies) a percentage (approximately 45%) of the fees generated from the prescriptions referred by the physicians. The pharmacies billed and received payment from the US Department of Labor’s (DOL) Office of Workers Compensation Program, which is a federal health care benefit program. Over the course of the conspiracy, the DOL paid over $8 million for the kickback-induced prescriptions.

Continue Reading Marketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic. Below is an overview of these actions and related COVID-19 vaccine information:

Full Approval of the Moderna COVID-19 Vaccine for 18+

On January 31, 2022, the FDA announced its full approval (licensing) of the Moderna COVID-19 Vaccine for individuals 18 and older. The Moderna vaccine had been administered under an Emergency Use Authorization (EUA) from the FDA since December 18, 2020.  This is the second COVID-19 vaccine to be approved by the FDA following approval of Pfizer-BioNTech’s COVID-19 vaccine on August 23, 2021. Notably, the approved Moderna COVID-19 vaccine will be marketed and known as the ‘Spikevax.’

Continue Reading COVID-19 Vaccine Update – February 2022

On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to enforce premarket review requirements for COVID-19 laboratory developed tests (LDTs). This prior policy, which waived premarket review requirements aimed at increasing broad public access to COVID-19 tests, was generally consistent with the FDA’s historical stance allowing laboratories to not seek approval of LDTs. With the policy announced by the Trump administration, laboratories again began offering their tests prior to or without an emergency use authorization (EUA) after the test was validated and a notification was provided to the FDA. While this policy expedited the availability of tests, the FDA contends that the policy also led to some poorly-performing tests being offered prior to FDA review. Notably, this prior policy did not apply to at-home or point of care collection tests, which have always required FDA review.
Continue Reading HHS Again Requires FDA Premarket Review for COVID-19 Tests

On August 19, 2021, Connecticut Governor Ned Lamont issued Executive Order No. 13C (the “Order”) to expand access to COVID-19 vaccination information for patients and providers (and school nurses) as public health authorities continue to promote vaccination efforts, implement recommendations for vaccine booster shots, and as schools adopt COVID-19 control measures for returning students and

On July 6, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-113 titled “An Act Concerning Opioids” (PA 21-113), which establishes pilot programs to help serve persons with opioid use disorder in urban, suburban, and rural communities, and requires the Commissioner of Public Health to issue and increase awareness of chronic pain treatment guidelines. PA 21-113 became effective on July 1, 2021.
Continue Reading Connecticut Legislature Passes Act to Help Address the Opioid Epidemic

On December 7, 2020, Connecticut Governor Ned Lamont signed Executive Order No. 9Q (the “Order”) in anticipation of the approval of COVID-19 vaccines. The Order addresses and expands COVID-19 vaccine administration, establishes flu vaccine reporting requirements for pharmacists, and limits out-of-network charges for administration of authorized COVID-19 vaccines. Specifically, the Order:
Continue Reading In Anticipation of COVID-19 Vaccine Approval, Connecticut Governor Ned Lamont Issues Executive Order To Facilitate Vaccine Administration and Reporting

On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector General (OIG) published two final rules (available here: November 30 Final Rule and December 2 Final Rule) which modify the safe harbor regulations to the federal Anti-Kickback Statute (AKS) and codify a new exception to the Civil

The Connecticut Department of Consumer Protection Drug Control Division (DCP) has issued guidance for health care providers regarding refills and reissuances of controlled substance prescriptions for patients without an in-person visit due to the COVID-19 pandemic. DCP explains that “practitioners may issue prescription refills for controlled substances using their professional discretion for a patient under their care without seeing the patient in-person within certain parameters.” The parameters are as follows:

  • Schedule-Specific Requirements for Controlled Substance Prescriptions
    • Schedule II prescriptions cannot be refilled; however, practitioners with a pre-existing relationship with a patient who have prescribed a particular controlled substance for the patient previously can reissue the prescription without an in-person visit. Additionally, no prescription for a Schedule II controlled substance can contain more than one (1) prescription.
    • Schedule III and IV prescriptions can be refilled up to five (5) times every six (6) months as authorized by the prescribing practitioner.
    • Schedule V prescriptions can be refilled as authorized by the prescribing practitioner.


Continue Reading Connecticut DCP Issues Guidance for Remotely Refilling Prescriptions

On March 27, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act, or the Act), Public Law 116-136, a trillion-dollar stimulus bill intended to provide financial assistance to individuals and business affected by the COVID-19 pandemic.  The Act contains a broad range of measures intended to bolster the economy in the midst of the COVID-19 pandemic.  Unsurprisingly, a central focus of the Act is the provision of relief and support for hospitals and health care providers on the front lines of the COVID-19 pandemic.  This article provides a brief overview of some of the major pieces of the CARES Act, and the firm will provide additional updates on key aspects of the Act.
Continue Reading CARES Act Provides Vital Financial Support for Health Care Providers on COVID-19 Front Lines

On March 23, 2020, New York Governor Andrew Cuomo issued an executive order (Executive Order) related to the COVID-19 public health emergency to ease regulatory requirements and expand the resources available to address the emergency.

Significant provisions of the Executive Order are as follows:

Provisions to Expand Facility Capacity

  • Orders the Commissioner of Health to direct all general hospitals, ambulatory surgery centers, office-based surgery practices and diagnostic and treatment centers to increase the number of beds available to patients, including by canceling all elective surgeries and procedures, as determined by the Commissioner. General hospitals in New York must submit to the New York Department of Health (DOH) their plans to increase available beds. As of this writing, the Commissioner has not yet released guidance defining elective surgeries or procedures or the schedule for general hospitals to submit their plans to DOH. The Executive Order gives the Commissioner the authority to suspend or revoke the operating certificate of any general hospital that is unable to meet the requirements of these directives.
  • Permits hospice residences to designate any number of beds as inpatient beds.
  • Permits the Commissioner to designate a health care facility as a trauma center or to extent a facility’s designation.
  • Waives laws related to hospital construction, minimum facility requirements, and governance to the extent necessary to provide for capacity expansion. Specifically, the Executive Order waives Section 2803 of the Public Health Law, and Parts 400, 401, 405, 409, 710, 711 and 712 of Title 10 of the NYCRR. Of note, the earlier Executive Order 202.5 had provided similar waivers but required prior approval from the Commissioner of Health or the Commissioner of the Office for Persons with Developmental Disabilities (see our summary of Executive Order 202.5 here).


Continue Reading New York Further Expands Facility Capacity and Practitioner Capacity in New Executive Order