[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]


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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.

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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.

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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