Request for Information: Opioid Analgesic Prescriber Education and Training Opportunities To Prevent Opioid Overdose and Opioid Use Disorder, 44640-44642 [2016-16067]

Download as PDF 44640 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices individual or entity used Federal facilities or consulted with Federal employees during a Challenge if the facilities and employees are made available to all individuals and entities participating in the Challenge on an equitable basis. General Submission Requirements In order for a Submission to be eligible to win this Challenge, it must meet the following requirements: 1. No HHS or ONC logo—The Solution must not use HHS’ or ONC’s logos or official seals and must not claim endorsement. 2. Functionality/Accuracy—A Solution may be disqualified if it fails to function as expressed in the description provided by the participant, or if it provides inaccurate or incomplete information. Registration Process for Participants To register for this Challenge, participants can access http:// www.challenge.gov and search for ‘‘Blockchain and Its Emerging Role in Healthcare and Health-related Research.’’ Prize Winners will be provided the following: • Opportunity to present their paper at a Blockchain & Healthcare Workshop Hosted at NIST • Paid travel to the Workshop; • Paid room and board for the Workshop; and • Paid Per Diem. Payment of the Prize Prize will be paid by contractor. asabaliauskas on DSK3SPTVN1PROD with NOTICES Basis Upon Which Winner Will Be Selected The evaluation process will begin by removing those that are not responsive to this Challenge or not in compliance with all rules for eligibility. Judges will examine all responsive and compliant submissions, and rate the entries. Judges will determine the most meritorious submissions, based on these ratings and select up to eight (8) finalists. Honorable Mentions may be included and announced, along with the winners on Challenge.gov. The judging panel will rate each submission based upon the effectiveness of the overall concept to help foster transformative change in the HealthIT culture, the viability of the proposed recommendations, the innovativeness of the approach, and its potential for achieving the objectives of ONC. Up to eight (8) submissions will be selected as winners. Winners will be VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 awarded with the opportunity to present their White Paper at a two-day Blockchain & Healthcare Workshop. In lieu of a monetary prize, finalists will be provided with full expenses for travel to the Workshop, which will be held at the NIST Headquarters in Gaithersburg, MD. At the end of the submission period, Submissions will be posted on the challenge Web site and will be reviewed, graded, and voted on by a steering committee. 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The Federal Agency sponsors reserve the right to disqualify any Submission that, in their discretion, PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 deems to violate these Official Rules, Terms & Conditions. Authority: 15 U.S.C. 3719. Karen DeSalvo, National Coordinator for Health Information Technology. [FR Doc. 2016–16133 Filed 7–6–16; 8:45 am] BILLING CODE 4150–45–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Request for Information: Opioid Analgesic Prescriber Education and Training Opportunities To Prevent Opioid Overdose and Opioid Use Disorder Office of the Assistant Secretary for Planning and Evaluation (ASPE), HHS. ACTION: Request for information. AGENCY: Deaths from drug overdose have risen steadily over the past two decades and have become the leading cause of injury death in the United States. Prescription drugs, especially opioid analgesics—a class of prescription drugs such as hydrocodone, oxycodone, morphine, and methadone used to treat both acute and chronic pain—have been increasingly implicated in drug overdose deaths over the last decade. Alarmingly, deaths related to opioid analgesic overdose have quadrupled since 1999, and this increase in deaths has been linked to parallel increases in opioid prescribing. As part of its comprehensive response to the opioid epidemic, HHS is actively working to stem overprescribing of opioids in a number of ways, including by providing clinicians with the tools and education they need to make informed prescribing decisions. In particular, HHS has developed a number of activities that support opioid analgesic prescriber education. This Request for Information (RFI) seeks comment on the most promising approaches in prescriber education and training programs and effective ways to leverage HHS programs to implement/expand them. DATES: Comments must be received at one of the addresses provided below, no later than 5 p.m. on September 6, 2016. ADDRESSES: Written comments may be submitted through any of the methods specified below. Please do not submit duplicate comments. • Federal eRulemaking Portal: You may submit electronic comments at http://www.regulations.gov. Follow the SUMMARY: E:\FR\FM\08JYN1.SGM 08JYN1 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES instructions for submitting electronic comments. Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word. • Regular, Express, or Overnight Mail: You may mail written comments (one original and two copies) to the following address only: U.S. Department of Health and Human Services, Office for Civil Rights, Attention: 1557 RFI (RIN 0945– AA02), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue SW., Washington, DC 20201. Mailed comments may be subject to delivery delays due to security procedures. Please allow sufficient time for mailed comments to be timely received in the event of delivery delays. • Hand Delivery or Courier: If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) to the following address only: Office for Civil Rights, Attention: 1557 RFI (RIN 0945–AA02), Hubert H. Humphrey Building, Room 509F, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the mail drop slots located in the main lobby of the building.) • Inspection of Public Comments: All comments received before the close of the comment period will be available for public inspection, including any personally identifiable or confidential business information that is included in a comment. We will post all comments received before the close of the comment period at http:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Office of the Assistant Secretary for Planning and Evaluation, 202–690– 7858. SUPPLEMENTARY INFORMATION: I. Background Education and training in pain management and appropriate opioid analgesic prescribing, including how to identify patients who may be at risk for opioid misuse and ensuring patients treated with opioids receive the appropriate dose and quantity of medication for their condition, are key elements of the response to the opioid epidemic. Surveys of healthcare providers indicate that they receive inadequate training on pain management, and many feel uncomfortable managing patients with pain. In addition, research has identified significant gaps and fragmentation in pain education in VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 health professional schools, and the National Pain Strategy indicates that health professional education is a central component of advancing a system of care in which all people receive high quality and evidence-based pain care. To improve education and training on pain management and appropriate opioid prescribing, HHS has developed programs that engage prescribers throughout their training and professional career. For example, in an effort to educate health professional students, the National Institutes on Drug Abuse (NIDA) coordinates the National Institutes of Health Pain Consortium’s Centers of Excellence in Pain Education that develop and distribute pain management curriculum resources for medical, dental, nursing, and pharmacy schools. Many HHS training initiatives target practicing clinicians throughout their learning and practice lifecycles. Some programs, such as NIDA’s NIDAMED program, offer opioid and pain management training as continuing education credit opportunities. Additionally, the Food and Drug Administration (FDA) has put in place a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid medications. The ER/LA Opioid Analgesic REMS requires manufacturers to make prescriber training available through accredited continuing education (CE) programs funded by the ER/LA sponsors. To assure that the training is balanced and to protect from industry influence, the training is based upon the FDA blueprint for Prescriber Education for ER/LA opioids and is made available through third-party CE providers. Other programs utilize a peer-to-peer mentoring model. The Substance Abuse and Mental Health Services Administration’s Providers’ Clinical Support System for Opioid Therapies (PCSS–O) is one such model that offers colleague support and mentoring as well as evidence-based educational resources on how to effectively utilize opioid analgesics for patients with pain and patients with opioid use disorders. And, other resources are intended to support decision making during an active patient encounter. The Centers for Disease Control and Prevention’s Guideline for Prescribing Opioids for Chronic Pain facilitates providers’ decision-making regarding appropriate pain treatment for patients 18 years and older in the primary care setting. II. Solicitation of Comments This RFI is seeking comment on the range of approaches to educating and PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 44641 training providers on pain management and appropriate opioid analgesic prescribing, including identifying patients at risk for abuse and prescribing the appropriate dose and quantity of medication for their condition. As noted above HHS has undertaken several programs to engage providers on these topics, and this RFI is meant to solicit input not only on those but also on other approaches. For example, HHS seeks comment on the impact of nonfederal prescriber training policies or programs on opioid analgesic prescriber competency: • How states have developed, promoted, and made pain management and opioid analgesic prescriber education available, • whether state requirements for mandatory pain management and opioid prescribing training have led to any changes in prescriber behavior and/or other outcomes as a result of these programs, • the challenges opioid education providers have faced in implementing opioid prescriber education initiatives, • which measures education providers use to evaluate the success of their interventions, or • how health information technology has been implemented to assist the prescriber in appropriate opioid prescribing and pain management. HHS also is soliciting suggestions for additional activities the Department could implement to ensure universal prescriber education on appropriate pain management and opioid prescribing. For example, additional HHS activities could include: • Adding new opioid prescriber education to Medicare Conditions of Participation and/or to Medicare enrollment requirements, • adding quality measures around safe opioid use to the specialty core measures that clinicians may choose to report under the Merit-based Incentive Payment System (MIPS), or • revising the ER/LA Opioid Analgesic REMS to require that prescribers of opioids receive appropriate training on pain management and safe opioid use before being able to prescribe specific opioids. Finally, HHS seeks feedback through this RFI on the ability of existing HHS education and training programs to educate all opioid analgesic prescribers on appropriate pain management and opioid prescribing including comments on the development and delivery of the content and on efforts to assess the impact of the training initiatives. E:\FR\FM\08JYN1.SGM 08JYN1 44642 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices III. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble. Dated: June 29, 2016. Kathryn E. Martin, Acting Assistant Secretary for Planning and Evaluation. [FR Doc. 2016–16067 Filed 7–6–16; 8:45 am] BILLING CODE 4150–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: July 1, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health. National Institutes of Health Public Workshop—Iron Screening and Supplementation of Iron-Replete Pregnant Women and Young Children The Office of Dietary Supplements at the National Institutes of Health (NIH) is sponsoring an open public workshop titled, ‘‘Iron Screening and Supplementation of Iron-replete Pregnant Women and Young Children,’’ September 28–29, 2016, on the NIH main campus in Bethesda, Maryland. It will also be available to be viewed live or later on-demand as a videocast. The workshop discussions will focus on the U.S. and developed countries and will serve to specify data gaps and research needs by (1) exploring current understanding of iron homeostasis in pregnant women and in young children (6-24 months); (2) identifying the challenges associated with measuring iron status and with screening practices; and (3) considering emerging issues associated with routine supplementation of iron-replete individuals. All persons are invited to attend, especially clinical educators, those who develop clinical recommendations, health care providers and researchers. Persons wishing to attend are required to register in advance of the conference. DATES: September 28–29, 2016; 8:30 to 5:15 p.m. (Eastern Time) on the first day and 8:00 to 12:30 p.m. on the second day. asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: National Institutes of Health, William H. Natcher Building; Natcher Conference Center, Building 45, Bethesda, Maryland, 20892. FOR FURTHER INFORMATION CONTACT: Ms. Cindy Rooney, Office of Dietary Supplements, National Institutes of Health, 6100 Executive Boulevard, ADDRESSES: VerDate Sep<11>2014 17:00 Jul 07, 2016 Jkt 238001 Room 3B01, Bethesda, MD 20892–7523, Email: rooneyc@mail.nih.gov. SUPPLEMENTARY INFORMATION: The conference is sponsored by the NIH Office of Dietary Supplements along with co-sponsors from other federal agencies. Information about the conference agenda, registration procedures, and videocast arrangements can be found at: https://eventssuport.com/events/NIH_Iron_Workshop. Through its Iron Initiative, the National Institutes of Health (NIH) Office of Dietary Supplements leads efforts to advance scientific understanding of iron and health: https://ods.od.nih.gov/Research/ Iron.aspx. [FR Doc. 2016–16254 Filed 7–7–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request National Institutes of Health (NIH) Loan Repayment Programs; Office of the Director (OD) Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Division of Loan Repayment (DLR), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 19, 2016, and page numbers 8514–8516, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. SUMMARY: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Steve Boehlert, Director of Operations, Division of Loan Repayment, National Institutes of Health, 6011 Executive Blvd., Room 206 (MSC 7650), Bethesda, Maryland 20892–7650. Mr. Boehlert may be contacted via email at BoehlerS@ od.nih.gov or by calling 301–451–4465. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: National Institutes of Health (NIH) Loan Repayment Programs (LRP). Type of Information Collection Request: Revision of a currently approved collection (OMB No. 0925–0361, expiration date 06/30/17). Form Numbers: NIH 2674–1, NIH 2674–2, NIH 2674–3, NIH 2674–4, NIH 2674–5, NIH 2674–6, NIH 2674–7, NIH 2674–8, NIH 2674–9, NIH 2674–10, NIH 2674– 11, NIH 2674–12, NIH 2674–13, NIH 2674–14, NIH 2674–15, NIH 2674–16, NIH 2674–17, NIH 2674–18, NIH 2674– 19, and NIH 2674–20 (new). Need and Use of Information Collection: The NIH makes available financial assistance, in the form of educational loan repayment, to M.D., Ph.D., Pharm.D., Psy.D., D.O., D.D.S., D.M.D., D.P.M., D.C., N.D., O.D., D.V.M., or equivalent degree holders who perform biomedical or behavioral research in NIH intramural laboratories or as extramural grantees or scientists funded by domestic non-profit organizations for a minimum of two years (three years for the General Research LRP) in research areas supporting the mission and priorities of the NIH. The AIDS Research Loan Repayment Program (AIDS–LRP) is authorized by section 487A of the Public Health Service Act (42 U.S.C. 288–1); the Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (CR–LRP) is authorized by section 487E (42 U.S.C. 288–5); the General Research Loan Repayment Program (GR–LRP) is authorized by section 487C of the Public Health Service Act (42 U.S.C. 288–3); the Clinical Research Loan Repayment Program (LRP–CR) is authorized by section 487F (42 U.S.C. 288–5a); the Pediatric Research Loan Repayment Program (PR–LRP) is authorized by E:\FR\FM\08JYN1.SGM 08JYN1

Agencies

[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44640-44642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16067]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Request for Information: Opioid Analgesic Prescriber Education 
and Training Opportunities To Prevent Opioid Overdose and Opioid Use 
Disorder

AGENCY: Office of the Assistant Secretary for Planning and Evaluation 
(ASPE), HHS.

ACTION: Request for information.

-----------------------------------------------------------------------

SUMMARY: Deaths from drug overdose have risen steadily over the past 
two decades and have become the leading cause of injury death in the 
United States. Prescription drugs, especially opioid analgesics--a 
class of prescription drugs such as hydrocodone, oxycodone, morphine, 
and methadone used to treat both acute and chronic pain--have been 
increasingly implicated in drug overdose deaths over the last decade. 
Alarmingly, deaths related to opioid analgesic overdose have quadrupled 
since 1999, and this increase in deaths has been linked to parallel 
increases in opioid prescribing. As part of its comprehensive response 
to the opioid epidemic, HHS is actively working to stem overprescribing 
of opioids in a number of ways, including by providing clinicians with 
the tools and education they need to make informed prescribing 
decisions. In particular, HHS has developed a number of activities that 
support opioid analgesic prescriber education. This Request for 
Information (RFI) seeks comment on the most promising approaches in 
prescriber education and training programs and effective ways to 
leverage HHS programs to implement/expand them.

DATES: Comments must be received at one of the addresses provided 
below, no later than 5 p.m. on September 6, 2016.

ADDRESSES: Written comments may be submitted through any of the methods 
specified below. Please do not submit duplicate comments.
     Federal eRulemaking Portal: You may submit electronic 
comments at http://www.regulations.gov. Follow the

[[Page 44641]]

instructions for submitting electronic comments. Attachments should be 
in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft 
Word.
     Regular, Express, or Overnight Mail: You may mail written 
comments (one original and two copies) to the following address only: 
U.S. Department of Health and Human Services, Office for Civil Rights, 
Attention: 1557 RFI (RIN 0945-AA02), Hubert H. Humphrey Building, Room 
509F, 200 Independence Avenue SW., Washington, DC 20201. Mailed 
comments may be subject to delivery delays due to security procedures. 
Please allow sufficient time for mailed comments to be timely received 
in the event of delivery delays.
     Hand Delivery or Courier: If you prefer, you may deliver 
(by hand or courier) your written comments (one original and two 
copies) to the following address only: Office for Civil Rights, 
Attention: 1557 RFI (RIN 0945-AA02), Hubert H. Humphrey Building, Room 
509F, 200 Independence Avenue SW., Washington, DC 20201. (Because 
access to the interior of the Hubert H. Humphrey Building is not 
readily available to persons without federal government identification, 
commenters are encouraged to leave their comments in the mail drop 
slots located in the main lobby of the building.)
     Inspection of Public Comments: All comments received 
before the close of the comment period will be available for public 
inspection, including any personally identifiable or confidential 
business information that is included in a comment. We will post all 
comments received before the close of the comment period at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Office of the Assistant Secretary for 
Planning and Evaluation, 202-690-7858.

SUPPLEMENTARY INFORMATION: 

I. Background

    Education and training in pain management and appropriate opioid 
analgesic prescribing, including how to identify patients who may be at 
risk for opioid misuse and ensuring patients treated with opioids 
receive the appropriate dose and quantity of medication for their 
condition, are key elements of the response to the opioid epidemic. 
Surveys of healthcare providers indicate that they receive inadequate 
training on pain management, and many feel uncomfortable managing 
patients with pain. In addition, research has identified significant 
gaps and fragmentation in pain education in health professional 
schools, and the National Pain Strategy indicates that health 
professional education is a central component of advancing a system of 
care in which all people receive high quality and evidence-based pain 
care.
    To improve education and training on pain management and 
appropriate opioid prescribing, HHS has developed programs that engage 
prescribers throughout their training and professional career. For 
example, in an effort to educate health professional students, the 
National Institutes on Drug Abuse (NIDA) coordinates the National 
Institutes of Health Pain Consortium's Centers of Excellence in Pain 
Education that develop and distribute pain management curriculum 
resources for medical, dental, nursing, and pharmacy schools.
    Many HHS training initiatives target practicing clinicians 
throughout their learning and practice lifecycles. Some programs, such 
as NIDA's NIDAMED program, offer opioid and pain management training as 
continuing education credit opportunities. Additionally, the Food and 
Drug Administration (FDA) has put in place a risk evaluation and 
mitigation strategy (REMS) for extended-release (ER) and long-acting 
(LA) opioid medications. The ER/LA Opioid Analgesic REMS requires 
manufacturers to make prescriber training available through accredited 
continuing education (CE) programs funded by the ER/LA sponsors. To 
assure that the training is balanced and to protect from industry 
influence, the training is based upon the FDA blueprint for Prescriber 
Education for ER/LA opioids and is made available through third-party 
CE providers.
    Other programs utilize a peer-to-peer mentoring model. The 
Substance Abuse and Mental Health Services Administration's Providers' 
Clinical Support System for Opioid Therapies (PCSS-O) is one such model 
that offers colleague support and mentoring as well as evidence-based 
educational resources on how to effectively utilize opioid analgesics 
for patients with pain and patients with opioid use disorders. And, 
other resources are intended to support decision making during an 
active patient encounter. The Centers for Disease Control and 
Prevention's Guideline for Prescribing Opioids for Chronic Pain 
facilitates providers' decision-making regarding appropriate pain 
treatment for patients 18 years and older in the primary care setting.

II. Solicitation of Comments

    This RFI is seeking comment on the range of approaches to educating 
and training providers on pain management and appropriate opioid 
analgesic prescribing, including identifying patients at risk for abuse 
and prescribing the appropriate dose and quantity of medication for 
their condition. As noted above HHS has undertaken several programs to 
engage providers on these topics, and this RFI is meant to solicit 
input not only on those but also on other approaches. For example, HHS 
seeks comment on the impact of non-federal prescriber training policies 
or programs on opioid analgesic prescriber competency:
     How states have developed, promoted, and made pain 
management and opioid analgesic prescriber education available,
     whether state requirements for mandatory pain management 
and opioid prescribing training have led to any changes in prescriber 
behavior and/or other outcomes as a result of these programs,
     the challenges opioid education providers have faced in 
implementing opioid prescriber education initiatives,
     which measures education providers use to evaluate the 
success of their interventions, or
     how health information technology has been implemented to 
assist the prescriber in appropriate opioid prescribing and pain 
management.
    HHS also is soliciting suggestions for additional activities the 
Department could implement to ensure universal prescriber education on 
appropriate pain management and opioid prescribing. For example, 
additional HHS activities could include:
     Adding new opioid prescriber education to Medicare 
Conditions of Participation and/or to Medicare enrollment requirements,
     adding quality measures around safe opioid use to the 
specialty core measures that clinicians may choose to report under the 
Merit-based Incentive Payment System (MIPS), or
     revising the ER/LA Opioid Analgesic REMS to require that 
prescribers of opioids receive appropriate training on pain management 
and safe opioid use before being able to prescribe specific opioids.
    Finally, HHS seeks feedback through this RFI on the ability of 
existing HHS education and training programs to educate all opioid 
analgesic prescribers on appropriate pain management and opioid 
prescribing including comments on the development and delivery of the 
content and on efforts to assess the impact of the training 
initiatives.

[[Page 44642]]

III. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble.

    Dated: June 29, 2016.
Kathryn E. Martin,
Acting Assistant Secretary for Planning and Evaluation.
[FR Doc. 2016-16067 Filed 7-6-16; 8:45 am]
 BILLING CODE 4150-15-P