Pharmaceuticals and Biologics

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

Rhode Island has issued important updates for health care providers related to COVID-19, available at https://health.ri.gov/diseases/ncov2019/for/providers/.  Providers should be aware of these updates including, among others, the following described below.
Continue Reading Rhode Island Issues Emergency Regulations on Off-Label Prescribing for COVID-19, and Guidance on Telehealth and Reciprocal Licensure

The Federal Drug Enforcement Agency (DEA) issued guidance permitting DEA-registered practitioners to prescribe controlled substances without an in-person medical exam of the patient for the duration of the COVID-19 public health emergency.
Continue Reading DEA Allows Providers to Prescribe Controlled Substances Without an In-Person Medical Examination During COVID-19 Public Health Emergency

Massachusetts executive agencies have been issuing an array of further guidance to the healthcare provider community regarding COVID-19.  All orders and guidance are available at https://www.mass.gov/2019coronavirus. Review of this website and CDC websites for periodic updates is strongly encouraged, as the situation is fluid and continually evolving.
Continue Reading Massachusetts COVID-19 Guidance for Health Care Providers, Payors and Laboratories on Issues Including Telehealth, Elective Procedures, COVID-19 Testing, and Provider Licensure