legal and regulatory developments in the field of behavioral health

Welcome to Ledger

Welcome to the fourth issue of the Greenberg Traurig Quarterly Behavioral Health Diary, which maintains behavioral health and integrated healthcare providers throughout the legal and regulatory development of behavioral health. Every quarter, we highlight recent legal changes, including, but not limited to, audit risks, significant litigation, enforcement and changes in health laws or regulations, such as health privacy, confidentiality and / or security issues, consent issues, data -share allowances and other cutting-edge arrangements and issues facing behavioral and integrated healthcare providers.

Legislators are urging you to switch to OTC status for naloxone text

In a bid to increase access to naloxone and potentially save lives, a group of 30 lawmakers from both parties wrote to seven major naloxone manufacturers in April 2022, urging them to seek naloxone (OTC) status for naloxone, a drug which quickly reverses the opioid. overdose. See a copy of the letter.

The United States has seen a dramatic increase in opioid overdose deaths since the COVID-19 pandemic began. More than 107,000 deaths were reported in the United States between December 2020 and December 2021. Some industry stakeholders raised issues in tandem with the over-the-counter discussion, namely how to deal with the price of OTC naloxone, for make it widely available when, like OTC drugs, it will no longer be covered by insurance.

Lawmakers noted that the FDA strongly supports changing the status of naloxone and has taken steps to facilitate the transition to OTC status, including the creation of a model fact label for medicines that can be used for OTC naloxone products. This was the first time the FDA had developed a model drug label for an OTC switch. Legislators noted that it is now the responsibility of manufacturers to provide the documents needed to carry out the change. The deputies’ letters were sent to the executive directors of a number of pharmaceutical companies. The American Medical Association, the American Society for Addiction Treatment and the Remedy Alliance support the letters.

Colorado Passes Bill to Resolve Conflicts of Interest in Regional Organizations Owned by Behavioral Health Care Providers

Colorado passed a bill on May 23, 2022, that would require certain regional organizations owned by behavioral health care providers that provide behavioral health services to the public (i.e., through the Medicaid program) to adhere to certain conflict conflict policies. interests to promote greater transparency and accountability. The affected organizations must comply with the new law by January 1, 2023.

Conflict of Interest in Public Behavioral Health, Colorado Senate Bill 22-106 requires managed care organizations (MCEs), administrative service organizations (ASOs), and managed service organizations (MSOs) owned by 25% or more of behavioral health services to comply with the following conflicts of interest policies:


Owners and board members should not control the decisions of the supplier network: Providers who have ownership or board membership in the MCE, ASO or MSO have no control, influence or decision-making authority over the creation of supplier networks. For ASOs and MSOs, providers with ownership or participation on the board will also have no control, influence or decision-making powers over how funding is distributed to any provider.


Required capital statements and reviews, network failures and percentage comparisons: Each MCE reports on a quarterly basis the number of providers that have applied to join the network and have been refused and provides a comparison of the tariff ranges for providers who own or have been on board against providers who do not own or have on board. of MCE. For ASOs and MSOs, the Behavioral Health Service (OBH) will review the allocation of ASO or MSO funding on a quarterly basis to ensure that all providers are treated equally for funding and compliance with applicable state and federal rules and regulations to ensures that there are no inappropriate preferences. is given to suppliers with ASO or MSO ownership or board membership.

(° C)

There is no co-operation of a contracted supplier with MCE, MSO or ASO without state approval: An employee of a contracted MCE provider may not be an employee of an MCE unless the employee is the Chief Clinical Director of the MCE or the Director of Use Management. The same restriction applies to ASO and MSO, unless the employee is the medical director of ASO or MSO. If the double employee is also an employee of a provider with board membership or ownership in the MCE, the MCE develops policies approved by certain government regulatory agencies or officials depending on the type of regional organization, to mitigate conflicts of interest the employee may have.


Restrictions on membership of the board of suppliers: The MCE, ASO and / or MSO board must not have more than 50% of the contracted providers as board members, and the MCE, ASO or MSO is encouraged to have a community member on the MCE, ASO, MSO board.

© 2022 Greenberg Traurig, LLP. All rights reserved. National Review of Law, Volume XII, Number 159

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