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

On November 20, 2020, the Department of Health & Human Services (HHS) released heavily anticipated final rules revising the regulatory exceptions to the Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statute (AKS) safe harbors, and the Beneficiary Inducements Civil Monetary Penalties (CMP) regulations.  The changes to the regulations go into effect on January 19, 2021 (except for one change to the Physician Self-Referral Law that becomes effective January 1, 2022). In a separate rule also released November 20th, HHS removed safe harbor protection for rebates involving prescription pharmaceuticals and created a new safe harbor for certain point-of-sale reductions in price on prescription pharmaceuticals and pharmacy benefit manager service fees.

The full text of each rule is available below.


Continue Reading Physician Self-Referral Law (Stark), Anti-Kickback Statute, and Beneficiary Inducement CMPs – HHS Releases Final Rules

On July 14, 2020 Connecticut Governor Lamont issued Executive Order No. 7HHH, in which the Governor modified state law to enable the Commissioner of the Department of Public Health (DPH) to temporarily suspend licensure, registration and certification requirements for certain DPH-regulated practitioners for the duration of the state public health and civil preparedness emergency.  Notably, in that Executive Order, the Governor stated that “healthcare providers from outside Connecticut have greatly enhanced the provision of healthcare services in Connecticut during the COVID-19 pandemic and thereby fundamentally improved the state’s ability to protect public health at critical time.”
Continue Reading Connecticut Authorizes Out-of-State Health Care Practitioners to Render Assistance for Remainder of COVID-19 Pandemic

The new Acting Director of Public Health in Connecticut, Deidre Gifford, recently rescinded a prior May 6, 2020, Department of Public Health (DPH) order that had eliminated the requirement that a request for collection or analysis of a COVID-19 specimen be made by a licensed physician or other licensed person authorized by law to make diagnoses, and eliminated the obligation to report the COVID-19 results to the licensed provider who ordered the testing. We previously wrote about the now rescinded DPH order and its relation to Governor Lamont’s Executive Order 7KK in a post, here. While the DPH order has been rescinded, Executive Order 7KK still remains in effect allowing pharmacists to order COVID-19 tests.

Continue Reading Connecticut DPH Reinstates Requirement that COVID-19 Tests be Ordered by Physician or Other Authorized Practitioner and that Results be Reported to the Ordering Practitioner

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