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On May 7, 2020 Connecticut Governor Ned Lamont issued Executive Order 7KK allowing pharmacists to order COVID-19 tests.

The order modifies Section 19a-36-D29 of the Regulations of Connecticut State Agencies to permit licensed pharmacists to order COVID-19 diagnostic tests consistent with the Clinical Laboratory Improvement Amendments. The modification also permits pharmacists to order any Food and Drug Administration (FDA) approved COVID-19 serology test that does not require venipuncture. Pharmacists are required to comply with all Department of Health testing reporting requirements. The Executive Order is effective immediately.
Continue Reading Connecticut Governor Ned Lamont Issues Executive Order Allowing Pharmacists to Order COVID-19 Tests

Massachusetts continues to issue directives and guidance for health care providers in response to COVID-19. In this post we highlight Orders and Guidance issued by Massachusetts Governor Baker and the Massachusetts Department of Public Health (DPH). The guidance addresses topics including collection of COVID-19 demographic information, use of alternative space for provision of health care treatment, health professional licensing, EMS transport of patients, hospital policies for returning exposed health care personnel to work, use of PPE and equipment, and updates for pharmacies.
Continue Reading Massachusetts Issues COVID-19 Orders and Guidance for Providers

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 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

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

On September 4, 2019, the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two whistleblower suits filed under the False Claims Act (FCA). The settlement addresses allegations of AKS violations between 2009-2013 by sales representatives of a company later acquired by Mallinckrodt via the “wining and dining” of physicians to induce Medicare prescriptions of that company’s drug. Interestingly, the settlements do not cover related allegations within those FCA suits that Mallinckrodt improperly used a patient assistance foundation to “pay illegal kickbacks in the form of copay subsidies” for the same drug.
Continue Reading Government Continues to Closely Scrutinize Pharmaceutical Marketing Practices

Connecticut Governor Ned Lamont recently signed into law Public Act No. 19-98 “An Act Concerning The Scope Of Practice Of Advanced Practice Registered Nurses” (PA 19-98), which generally expands the scope of practice for Connecticut-licensed advanced practice registered nurses (APRNs). Among other things, PA 19-98 addresses matters related to medical records, emergency treatment, insurance coverage, and workers’ compensation, as further described below. PA 19-98 becomes effective October 1, 2019.
Continue Reading Connecticut Expands Scope of Practice for Advanced Practice Registered Nurses

On July 9, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-191 “An Act Addressing Opioid Use” (PA 19-191). PA 19-191 makes various revisions to Connecticut’s opioid use prevention and treatment statutes, and also creates new legislation pertaining to opioid use prevention and treatment.
Continue Reading Connecticut Legislature Modifies Statutes Relevant to Preventing and Treating Opioid Use Disorder

In a Memorandum Opinion, Judge Amit P. Mehta, of the U.S. District Court for the District of Columbia, vacated a U.S. Department of Health and Human Services (HHS) Final Rule, just days before its July 9 effective date. The Final Rule would have required the list prices of prescription drugs to be included in direct-to-consumer advertisements.
Continue Reading Federal Judge Vacates Final Rule on Drug Pricing Transparency in Consumer Advertising