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Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations outreach services will increase the number of veterans who receive antagonist prescriptions, aid in tracking the most at risk of the high-risk population, aid in the dissemination of pain management alternatives, and overall reduce the risk of opioid misuse and overdose events. The commenter also stated that outreach has proven effective in several studies conducted all over the US for people suffering with Opioid Use Disorder and is a main factor is reducing repeat overdose events. The commenter stated that these outreach practices are already occurring in VA and should be folded into the regulation to ensure their continuation as outreach is an integral part of increasing the effectiveness of this rules stated goal.
VA notes that this rulemaking is limited to the exemption of copayments for opioid antagonist education and dispensing of opioid antagonists to veterans identified by VA health care professionals as being at high risk of overdose. VA already has treatment programs and outreach programs in place for identification and treatment of veterans at risk of opioid use disorder.
The provision of VA outreach programs for opioid use disorder is outside the scope of the proposed rulemaking, and VA generally seeks to avoid regulating outreach practices to allow for innovative approaches to be adopted to support safe and effective patient care.
VA is not making any changes based on this comment.
Comments on the impact analysis.
A commenter had concerns regarding the impact analysis that accompanied the rulemaking. The commenter stated that the impact analysis projected a loss of revenue of more than $150,000 with increases for each year of this rules existence due to the copayment exemptions. The commenter noted that the impact analysis did not state where this revenue stream would be diverted from internally and how this may impact other veteran services of equal or greater importance. The commenter queried whether VA plans to apply for a grant under the Food, Drug, and Cosmetic Act chapter 9 of title 21, U.S.C. for the emergency treatment of opioid overdose, which can offset at least $200,000 of antagonist costs that is greater than the yearly projected loss of revenue from this rule.
VA believes the benefits of educating veterans on the risks of opioids and utilization of opioid antagonists during an overdose to potentially save a life outweighs any loss of revenue from VA
copayments. VA anticipates no reduction or diversion of funds from other programs as a result of this
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rulemaking. VA has already been implementing this authority, and VAs budget requests already reflect the loss identified in the impact analysis. We are not making any changes based on this comment.
Based on the rationale set forth in the Supplementary Information to the proposed rule and in this final rule, VA
is adopting the proposed rule with no changes.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563
direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, and other advantages;
distributive impacts; and equity.
Executive Order 13563 Improving Regulation and Regulatory Review emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.
Regulatory Flexibility Act The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act 5 U.S.C. 601612. The adoption of the rule does not directly affect any small entities. There are no small entities involved with VAs process or adjustment of veterans copayments for medications or services. The provisions of this rulemaking only apply to the internal operations of VA and to individual veterans.
Therefore, pursuant to 5 U.S.C.
605b, the initial and final regulatory flexibility analysis requirements of 5
U.S.C. 603 and 604 do not apply.
Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more adjusted annually for inflation in any one year. This final rule will have no
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such effect on State, local, and tribal governments, or on the private sector.
Paperwork Reduction Act This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 44 U.S.C. 3501 3521.
Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance program number and title for this final rule are as follows: 64.009, Veterans Medical Care Benefits; 64.012, Veterans Prescription Service; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.041, VHA
Outpatient Specialty Care; 64.045, VHA
Outpatient Ancillary Services; 64.047, VHA Primary Care; 64.048, VHA Mental Health Clinics.
Congressional Review Act Pursuant to the Congressional Review Act 5 U.S.C. 801 et seq., the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 8042.
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programshealth, Grant programs veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and Dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans.
Signing Authority Denis McDonough, Secretary of Veterans Affairs, approved this document on September 10, 2021, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.
Consuela Benjamin, Regulations Development Coordinator, Office of Regulation Policy & Management, Office of General Counsel, Department of Veterans Affairs.

For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR part 17 as set forth below:
PART 17MEDICAL
1. The general authority citation for part 17 continues to read as follows:

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20SER1