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Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations
that are used to generate a high-risk status and thus, a waived copayment.
The commenter recommended that VA
expand the rule to capture not only those considered high-risk, but also those residing in highly impacted regions, such as rural communities.
Another commenter similarly recommended including additional items in the definition of high risk, such as considering all veterans who requested opioid antagonists in geographical areas that see higher rates of opioid use and areas considered rural by the Federal Office of Rural Health Policy to be high risk. The commenter indicated that veterans in rural areas have limited access to health care and treatment centers, and delays in emergency medical services become critical when an accidental overdose occurs. The commenter added that VA
should create the most inclusive definition possible and consider other, less obvious, circumstances veterans may face that could render them at high risk of opioid addiction. The commenter also stated that by utilizing a model which casts a wider net for assistance, more veterans and those in their immediate circles are likely to benefit from these proposals.
As previously stated in this rulemaking, VAs definition of high risk veteran is broad enough to allow health care professionals the discretion to provide opioid antagonists and education on those medications to any veteran without charging a copayment.
In addition, VA has developed numerous resources to support identification of patients at risk for overdose, including the VA Opioid Overdose Education and Naloxone Distribution OEND Risk Report which includes patients with various opioid pharmacotherapy and Opioid Use Disorder risk factors; VA Stratification Tool for Opioid Risk Mitigation STORM, which uses predictive analytics to identify patients prescribed opioids who are at high risk for overdose and/or suicide; and incorporating the Risk Index for Overdose or Serious Opioid-induced Respiratory Depression RIOSORD into multiple reports to assist with patient identification. VA clinicians provide patient-centered care that takes into account the complexity of conditions and circumstances with which patients presentincluding their work, home, support system, and communitywhen conducting risk assessments and developing treatment plans. Based on the broad definition for this rule, which allows clinicians to provide opioid antagonists and related education to any
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veteran they deem may benefit from ready availability of an opioid antagonist, VA is not making any changes to its definition of high risk in response to this comment.
Another commenter stated that opioid overdoses can occur even when someone is taking an opioid exactly as prescribed by their doctor, and even veterans who are not considered high risk can still die of an overdose or be left with long term brain damage.
Therefore, the commenter concluded, it is imperative that all veterans taking opioids are educated on the dangers of opioid induced respiratory depression OIRD and are provided the monitoring technology to help keep them safe. The commenter encouraged VA to utilize continuous physiologic monitoring with notifications for all patients using opioids, particularly during periods of sleep and rest. The commenter added that such monitoring has been shown to reduce opioid overdose deaths through earlier interventions and rapid response team activations when necessary. The commenter recommended that VA
include the following in the list of factors that indicate that an individual is at high risk of overdose: Individuals taking other sedating medications, including alcohol, marijuana, benzodiazepines and/or gabapentin;
older adults; depression or mental health conditions; sleep apnea.
VA notes the specific modalities for treatment, such as monitoring for OIRD, are determined by the VA national program office responsible for developing guidance to VA staff overseeing the provision of care at the facility level. The establishment of such modalities are outside the scope of the proposed rulemaking. VA believes that the proposed definition of a high risk veteran is broad enough to grant health care professionals the discretion to identify veterans who such professionals consider to be high risk;
the addition of the factors identified by the commenter would not enhance the proposed definition. Moreover, VAs aforementioned STORM model takes into consideration many of the factors described by the commenter that are available in VA data e.g., substance use disorders, benzodiazepine and gabapentin prescriptions, age, mental health diagnoses, and sleep apnea.
These factors are displayed in a VAprovider facing clinical dashboard for patients prescribed opioids as well as patients with opioid use disorders. VA
is not making any changes based on these comments.
Comments on elimination of other types of copayments.

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A commenter was generally in support of the rule but recommended the rule also eliminate any cost to veterans relating to substance use disorder counseling, rehabilitation, psychological treatment, and inpatient care. The commenter added that care coordination between providers must become an equal priority to prevent over-prescription. In addition, the commenter stated that opioid antagonists should be treated as the last resort in reducing overdose deaths and not a course of treatment. The commenter stated the proposed rule should be only the first step in ensuring that high risk veterans face no obstacles in gaining access to the treatment that they need ahead of any possible overdose incident.
As previously stated in this rulemaking, section 915 of Public Law 114198 and section 243 of Division A
of Public Law 114223 provide for the elimination of a copayment for the provision of opioid antagonists and for outpatient visits whose sole purpose is for the provision of education on the use of opioid antagonists. The elimination of copayments for substance use disorder counseling, rehabilitation, psychological treatment, and inpatient care are beyond the scope of the proposed rule. However, VAs implementation of opioid antagonist education emphasizes the importance of connecting patients, including those with opioid use disorder, with treatment e.g., a standardized patient education brochure recommends considering seeking help for substance use disorder SUD treatment and includes a link to the VA SUD Program Locator. VA has also streamlined Prescription Drug Monitoring Program PDMP checks incorporating an integrated Information Technology solution that allows providers to check for controlled substance prescriptions outside VA.
This mechanism makes it easy for providers to check the PDMP for opioid prescriptions external to VA within the Computerized Patient Record System.
VA also has programs in place to assist veterans experiencing financial hardship, including measures to identify barriers for veterans at higher risk due to SUD. VA is not making any changes based on this comment.
Comments on Outreach One commenter suggested that the rule should also ensure that VA provide outreach services to identify high-risk veterans, encourage educational outpatient visits, and follow-up before or after both outpatient and inpatient visits for treatment and education. The commenter indicated that providing
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