March 30, 2020

March 29, 2020

Subscribe to Latest Legal News and Analysis

March 28, 2020

Subscribe to Latest Legal News and Analysis

March 27, 2020

Subscribe to Latest Legal News and Analysis

Rhode Island Issues Emergency Regulations on Off-Label Prescribing for COVID-19, and Guidance on Telehealth and Reciprocal Licensure

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.

Off-Label Prescribing

On March 22, the Rhode Island Department of Health (RIDOH) issued emergency regulations governing off-label prescribing of FDA-approved medication for the purposes of treating COVID-19. The emergency regulations and requirements do not apply to licensed Rhode Island physicians who are board certified in the American Board of Medical Specialties of Infectious Disease and/or Critical Care.

Under the emergency regulation, a practitioner prescribing an FDA-approved medication for the off-label purpose of treating COVID-19 must meet the following requirements:

  1. Indicate on the prescription the ICD-10 diagnosis code.

  2. Indicate on the prescription a telephone number at which the dispensing authority (e.g., pharmacist) may reach the health care provider to address questions relative to dose and treatment.

  3. Document in the patient’s medical record that the specific risks and benefits of the off-label treatment were discussed with the patient.

  4. Document in the patient’s medical record the clinical rationale for the off-label prescribing, citing:

    • a. At least one peer-reviewed article that justifies the clinical decision for the off-label prescribing, in the event that the FDA publishes such guidance.

    • b. Applicable FDA guidance justifying the clinical decision for the off-label prescribing, in the event that the FDA publishes such guidance.

The regulations provide that practitioners may not prescribe any medication for COVID-19, unless treatment or prevention of COVID or similar infectious diseases is within the practitioner’s usual and customary scope of practice.

The emergency regulations are set forth at 216-RICR-20-20-6, under a new Part 6 titled Off Label Prescribing Of Medications For Covid-19.

Reciprocal Licensing

As of March 18, 2020, out-of-state licensed professionals may obtain a temporary 90-day license from RIDOH so that they may temporarily practice in Rhode Island. See https://health.ri.gov/licenses/ for the list of licensed professionals who may obtain such temporary licenses, and for the application form.

Telemedicine

Per Executive Order 20-06 issued ­­­­on March 18, 2020, by Governor Gina M. Raimondo, Rhode Island insurance carriers must establish reasonable requirements for coverage for clinically appropriate, medically necessary telemedicine services delivered by in-network providers, including audio-only telephone conversations, at rates not lower than services delivered in person. In addition, the executive order suspended the patient location requirement for telemedicine, and provided that patients may receive telemedicine at any location. The order is in effect from the date issued until April 17, 2020.

Similarly, as of March 18, 2020, Rhode Island Medicaid will reimburse for clinically appropriate, medically necessary covered services, including behavioral health services to members via telehealth. This includes both fee-for-service and managed care. The RI Medicaid Guidance Memo sets out the fee-for-service billing codes eligible for telehealth services.

Copyright © 2020 Robinson & Cole LLP. All rights reserved.

TRENDING LEGAL ANALYSIS


About this Author

Anna Gurevich Healthcare Attorney Robinson Cole Law Firm
Associate

Anna Gurevich advises hospitals, physician groups, community providers, and other health care entities on a variety of health law and general business issues. She is a member of the firm's Health Law Group. Her practice focuses on counseling health care providers in complex business arrangements and regulatory issues. Prior to joining Robinson+Cole, Anna worked at a health care law firm and a large academic medical center. 

Regulatory

Anna provides legal counsel to health care clients on a variety of...

617-557-5971
Melissa Lisa Thompson Health Lawyer Robinson Cole Law Firm
Partner

Lisa Thompson advises companies, senior management, and their boards of directors, with a focus on the health care, life sciences and technology industries. She is a member of the firm’s Health Law Group and Data Privacy + Cybersecurity Team.  She is also an arbitrator on the Commercial panel and the Health Care panel of the American Arbitration Association.  

Health Care, Life Science and Technology Industries

Lisa represents domestic and international clients in the health care, life science and technology industries, including pharmaceutical companies, medical device manufacturers, biotechnology companies, hospital systems, academic medical centers, health information exchanges (HIEs) and technology services providers.  In addition, she has represented third party administrators, pharmacy benefit managers, health plans, laboratories, physician practices, pharmacies and retail pharmacy chains, among others in these industries.

Lisa handles a range of matters, including corporate law and contracting, government investigations and audits, clinical research law, and matters involving Institutional Review Boards (IRBs). She has extensive experience representing clients on matters involving privacy and security including HIPAA, reimbursement, Medicare and Medicaid, state and federal surveys and termination actions, managed care disputes, pharmacy and compounding laws, fraud and abuse, Stark Law, anti-kickback, and federal program exclusions.

Lisa’s life sciences experience includes U.S. Food and Drug Administration (FDA) compliance and regulatory matters, product recalls and liability claims, FDA citizen petitions and appeals, labeling review, advertising and marketing compliance, drug and medical device reimbursement, clinical research agreements, Sunshine Act compliance, and commercial contracting. Her technology sector experience includes advising on privacy and security, software licensing, data use agreements, information exchange system agreements, and regulatory requirements.

She formerly served in-house as chief counsel for an international medical device manufacturer, as general counsel for a pharmacy benefit management company, and as corporate, privacy, and research counsel for a major academic medical center. She is a co-editor and contributor for the firm’s blog, Health Law Diagnosis.

617-557-5918