Update from SAMHSA. NASCSA 33 nd Annual Conference San Antonio, Texas October 19, 2017

Transcription

1 Update from SAMHSA Anthony B Campbell RPH, D.O., FACP Center for Substance Abuse Treatment Substance Abuse Mental Health Services Administration U.S. Department of Health & Human Services NASCSA 33 nd Annual Conference San Antonio, Texas October 19, 2017

2 Disclosure Statement I have nothing to disclose.

3 Overview Crisis Update HHS Initiates CARA Act st Century Cures Act New Assistant Secretary for Mental Health and Substance Use initiatives Update PDMPs 3

4 Acting United States Secretary of Health and Human Services Eric David Hargan Mr. Hargan is a shareholder of Greenberg Traurig, LLP in its Health & FDA Business practice, based in Chicago. He earned a BA cum laude in philosophy from Harvard University, and a JD from Columbia University Law School. Mr. Hargan previously served the Department from as Deputy General Counsel, as Principal Associate Deputy Secretary and as Acting Deputy Secretary. In , he served as Co-Chair and Convener of the Healthcare and Human Services Transition Committee for Illinois Governor Bruce Rauner. 4 4

5 Assistant Secretary for Mental Health and Substance Use Elinore McCance-Katz, M.D., Ph.D. The first Assistant Secretary for Mental Health and Substance Use. She obtained her Ph.D. from Yale University with a specialty in Infectious Disease Epidemiology and is a graduate of the University of Connecticut School of Medicine. She is board certified in General Psychiatry and in Addiction Psychiatry. She is a Distinguished Fellow of the American Academy of Addiction Psychiatry with more than 25 years as a clinician, teacher, and clinical researcher.. 5

6 Aaaah Chores done, Wife and Kids gone and uninterrupted football! Life is good! 6

7 The Growing Drug Overdose Epidemic 7 7

8 More Americans lost to drugs than in Vietnam War The US military saw 58,000 casualties during Vietnam; this year, drug overdose deaths are expected to reach an all-time high of 71,600. Opioids can include both prescription drugs such as hydrocodone oxycodone,fentanyl as well as illegal drugs like heroin Misuse of a narcotic includes: using someone else's prescription drugs, using a higher dose than prescribed or buying prescription drugs off the street. 8

9 Source Where Pain Relievers Were Obtained for Most Recent Nonmedical Use among Past Year Users Aged 12 or Older: 2008 Friend/Relative for Free Bought from Friend/Relative Took from Friend/Relative Prescription from One Doctor From Drug Dealer or Stranger From Internet 18.0% 5.4% 8.9% 0.4% 4.3% Friends and relatives are the overwhelming source for obtaining pain relievers for nonmedical use. 55.9% 81.7% of pain relievers obtained from friend/relative for free originated from one doctor. 1.6% were obtained from a drug dealer. Note: Totals may not sum to 100% because of rounding or because suppressed estimates are not shown. Source: NSDUH

10 National Survey on Drug Use and Health (NSDUH) Approximately 11.8 million Americans misused an opioid in 2016, the new report says. Of those, just 8% used heroin. The majority misused prescription painkillers, and the main reason wasn't to get high but to get pain relief. In addition, an estimated 2.1 million people were addicted to heroin or prescription painkillers last year, a number that has remained fairly constant since But while opioid use hasn't changed much, the number of drug overdoses is expected to grow. 10

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12 US heroin deaths jump 533% since National Survey on Drug Use and Health The number of heroin users in the United States jumped from 404,000 in 2002 to 948,000 in 2016, a 135% increase, according to the most recent government numbers. The number of people who had fatal overdoses related to heroin has skyrocketed from 2,089 in 2002 to an estimated 13,219 in a 533% jump. 12

13 Overdoses expected to double According to the US Centers for Disease Control and Prevention, drug overdoses are the leading cause of accidental death in America, killing more people than guns or car accidents. It's a trend that doesn't appear to be reversing course. The CDC estimates that there were more than 52,000 overdose deaths for 2016 and projects that number to climb 38% to over 71,000 in Opioids continue to be the drivers for these overdoses, including both legally prescribed prescription painkillers as well as illegal drugs. In fact, the number of overdose deaths related to merely fentanyl is expected to more than double, from an estimated 9,945 in 2016 to 20,145 in 2017, the CDC 13

14 The rise of cocaine The CDC is also seeing a trend in overdose deaths related to cocaine, which have increased steadily from over 4,000 in 2009 to over 6,700 in The agency expects that number to rise to over 6,900 in 2016 and then to make a 52% jump to almost 11,000 cocaine-related deaths this year. 14

15 Federal Government Response

16 Current administration Approves $70 million in grants to address the opioid crisis The availability of over $70 million over multiple years to help communities and healthcare providers prevent opioid overdose deaths and provide treatment for opioid use disorder, of which $28 million will be dedicated for medicationassisted treatment (MAT). 16

17 HHS specific strategies (5) Strengthening public health surveillance Advancing the practice of pain management Improving access to treatment and recovery services Targeting availability and distribution of overdose-reversing drugs (naloxone, Narcan) Supporting cutting-edge research. 17

18 SAMHSA s Specific Strategic Initiatives (6) 1. Prevention of Substance Abuse and Mental Illness 2. Trauma and Justice 3. Recovery Support 4. Health Care and Health Systems Integration 5. Health Information Technology 6. Workforce Development

19 SAMHSA s Substance Misuse and Abuse Prevention and Treatment Efforts Substance Abuse Prevention and Treatment Block Grant (SABG) Partnerships for Success grants Screening, Brief Intervention, and Referral to Treatment SBIRT Drug Free Communities Substance Abuse Block Grant Treatment Capacity Expansion MAT: Rx Drug and Opioid Addiction PCSS-Opioids and PCSS-MAT Addiction Technology Transfer Centers ATTC Opioid Treatment Programs & Regulatory Activities Opioid Overdose Prevention Toolkit Pregnant and Postpartum Women Drug Court & Offender Reentry Treatment Programs Minority AIDS and HIV/AIDS Outreach Federal Drug-Free Workplace Program Not Worth the Risk, Even If It s Legal (pamphlet series) SAMHSA/CDC Prescription Drug Abuse Prevention Campaign

20 2014 SABG Report: SAMHSA s Block Grant: Expanding Access for Critical Services Treatment, recovery, and overdose prevention services provided for >1.77 million Americans Population-based primary prevention programs estimated to have reached more than 285 million people SABG provided approximately 71% of the overall prevention expenditures reported by state authorities

21 FY 2016 Strategic Prevention Framework for Prescription Drugs

22 FY 2016 Grants to Prevent Prescription Drug/Opioid Overdose-Related Deaths

23 FY 2016 Targeted Capacity Expansion: MAT- Prescription Drug and Opioid Addiction

24 Partnerships for Workforce Development Focus on safe opioid prescribing Focus on OUD treatment Focus on CMEaccredited trainings on safe use of opioids

25 Expanding Access: Buprenorphine Final Rule

26 Overview of Buprenorphine Final Rule 42 CFR Part 8, subpart A sets forth the general provisions of the rule Current subparts A, B, and C have changed to subparts B, C, D, respectively, and apply only to OTPs Subpart E is reserved Subpart F contains the final rule which increases the highest number of patients a practitioner can treat to

27 What is the process to request a patient limit of 275? Practitioners must complete the Request for Patient Limit Increase form and provide assurance that they will: 1) Adhere to nationally recognized evidence-based treatment guidelines 2) Provide patients with or connect patients to necessary behavioral health services 3) Provide appropriate releases of information to permit care coordination with behavioral health, medical, and other service practitioners 4) Use patient data to inform the improvement of 27 outcomes

28 What is the process to request a patient limit of 275? (cont) 5) Adhere to a diversion control plan to reduce the possibility of buprenorphine diversion 6) Develop a plan to assure continuous access in the event of an emergency situation 7) Notify all patients above the 100 patient limit that they will not be able to provide buprenorphine to them if higher patient limit is not renewed or renewal request is denied. Ensure that patients are transferred to another practitioner. 28

29 How will a Request for Patient Limit increase be processed? Not later than 45 days after the date on which SAMHSA receives a practitioner's initial or renewal Request for Patient Limit Increase, SAMHSA shall approve or deny the request. A practitioner's Request for Patient Limit Increase will be approved if the practitioner satisfies all applicable requirements. A practitioner's approval to treat up to 275 patients under this section will extend for a term not to exceed 3 years 29

30 Request for Patient Limit increase Denial SAMHSA may deny a practitioner's Request for Patient Limit Increase if SAMHSA determines that: The Request for Patient Limit Increase is deficient in any respect; or The practitioner has knowingly submitted false statements or made misrepresentations of fact in the practitioner's Request for Patient Limit Increase. If SAMHSA denies a practitioner's Request for Patient Limit Increase (or renewal), SAMHSA shall notify the practitioner of the reasons for the denial. 30

31 8.630 What must practitioners do in order to maintain their approval to treat up to 275 patients? A practitioner whose Request for Patient Limit Increase is approved in accordance with shall maintain all eligibility requirements specified in 8.610, and all attestations made in accordance with 8.620(b), during the practitioner's 3-year approval term. Failure to do so may result in SAMHSA withdrawing its approval of a practitioner's Request for Patient Limit Increase. All practitioners whose Request for Patient Limit Increase has been approved must provide reports to SAMHSA as specified in section

32 8.650 Can SAMHSAs approval of a practitioner s Request for Patient Limit Increase be suspended or revoked? SAMHSA, at any time during a practitioner s 3 year approval term, may suspend or revoke its approval of a practitioner's Request for Patient Limit Increase if it is determined that: Immediate action is necessary to protect public health or safety; The practitioner made misrepresentations in the practitioner's Request for Patient Limit Increase; The practitioner no longer satisfies the requirements of this subpart; or The practitioner has been found to have violated the CSA 32

33 8.655 Can a practitioner request to temporarily treat up to 275 patients in emergency situations? Practitioners with a current waiver to prescribe up to 100 patients and who are not otherwise eligible to treat up to 275 patients may request a temporary increase to treat up to 275 patients if the practitioner provides information and documentation that: Describes the emergency situation in sufficient detail so as to allow a determination to be made regarding whether the situation qualifies as an emergency situation as defined in 8.2, and that provides a justification for an immediate increase in that practitioner's patient limit; Identifies a period of time, not longer than 6 months, in which the higher patient limit should apply, and provides a rationale for the period of time requested; and Describes an explicit and feasible plan to meet the public and individual health needs of the impacted persons once the practitioner's approval to treat up to 275 patients expires. 33

34 For more Rule Information Final Rule New Request for Patient Increase Form Contact SAMHSA CSAT at to receive the form and guidance when available. 34

35 COMPREHENSIVE ADDICTION AND RECOVERY (CARA) ACT OF 2016 (July ) 35

36 CARA Act 2016 ttp:// On July 22, 2016, President Obama signed into law the Comprehensive Addiction and Recovery Act (P.L ). This is the first major federal addiction legislation in 40 years, and the most comprehensive effort undertaken to address the opioid epidemic, encompassing all six pillars Prevention, Treatment, Recovery, Law enforcement, Criminal justice reform, 36 Overdose reversal.

37 COMPREHENSIVE ADDICTION AND RECOVERY ACT (CARA) OF 2016 Authorizes the Attorney General and Secretary of Health and Human Services to award grants to address the national epidemics of prescription opioid abuse and heroin use, Establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. 37

38 Brief Summary of Provisions of CARA Expand prevention and educational efforts particularly aimed at teens, parents and other caretakers, and aging populations to prevent the abuse of methamphetamines, opioids and heroin, and to promote treatment and recovery. Expand the availability of naloxone to law enforcement agencies and other first responders to help in the reversal of overdoses to save lives. Expand resources to identify and treat incarcerated individuals suffering from addiction disorders promptly by collaborating with criminal justice stakeholders and by providing evidence-based treatment.

39 Brief Summary of Provisions of CARA Expand disposal sites for unwanted prescription medications to keep them out of the hands of our children and adolescents. Launch an evidence-based opioid and heroin treatment and intervention program to expand best practices throughout the country. Launch a medication-assisted treatment and intervention demonstration program. Strengthen prescription drug monitoring programs to help states monitor and track prescription drug diversion and to help at-risk individuals access services.

40 CARA Funding While it authorizes over $181 million each year in new funding to fight the opioid epidemic, monies must be appropriated every year, through the regular appropriations process, in order for it to be distributed in accordance with the law.

41 41 21st Century Cures Act

42 21st Century Cures Act The bill provides for $4.8 billion in new funding for the National Institutes of Health; of that, $1.8 billion is reserved for the cancer moonshot launched by Vice President Biden to accelerate research in that field. Another $1.6 billion is earmarked for brain diseases including Alzheimer s. $500 million in new funding for the Food and Drug Administration (streamline drug approval) $1 billion in grants to help states deal with opioid abuse.

43 21st Century Cures Act State Targeted Response to the Opioid Crisis Grants (Opioid STR) $485 million to all 50 states, the District of Columbia, four U.S. territories, and the free associated states of Palau and Micronesia for opioid abuse prevention, treatment, and recovery based on unmet need for Opioid Use Disorder treatment and drug poisoning deaths in each state or territory. 43

44 21st Century Cures Act - SAMHSA grants Medication-Assisted Treatment and Prescription Drugs Opioid Addiction (MAT PDOA): Up to $28 million to 5 grantees to increase access of medication-assisted treatment for opioid use disorder. Medication-assisted treatment combines behavioral therapy and FDA-approved medication. First Responders: Up to $41.7 million over 4 years available to approximately 30 grantees to train and provide resources for first responders and members of other key community sectors on carrying and administering an FDA approved product for emergency treatment of known or suspected opioid overdose. Improving Access to Overdose Treatment: Up to $1 million over 5 years to one grantee to expand availability to overdose reversal medications in healthcare settings and to establish protocols to connect patients who have experienced a drug overdose with appropriate treatment 44

45 21st Century Cures Act Additionally, released two other Comprehensive Addiction and Recovery Act (CARA)-related funding opportunities. State Pilot Grant Program for Treatment for Pregnant and Postpartum Women: Up to $3.3 million to support a range of family-based services for pregnant and postpartum women with substance use disorder. Building Communities of Recovery: Up to $2.6 million to mobilize resources within and outside of the recovery community to increase the prevalence and quality of long-term recovery support from substance abuse and addiction. 45

46 Assistant Secretary for Mental Health and Substance Use

47 Congress: Creation of Assistant Secretary for Mental Health and Substance Use 21 st Century Cures Act Section 6001: Establishes Assistant Secretary for Mental Health and Substance Use to head SAMHSA Requires the Assistant Secretary to: o Maintain a system to disseminate research findings and Evidence based Practices (EBP) to service providers to improve prevention and treatment services o Ensure that grants are subject to performance and outcome evaluations; conduct ongoing oversight of grantees o Consult with stakeholders to improve community based and other mental health services including for adults with Serious Mental Illness (SMI) and children with Serious Emotional Disturbance (SED). o Collaborate with other departments (VA, DoD, HUD, DOL) to improve care to veterans and service members and support programs to address chronic homelessness o Work with stakeholders to improve the recruitment and retention of mental health and substance use disorder professionals

48 SMI: Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC) Public/federal partnership to review current issues in addressing Serious Mental Illness, federal program review, and recommendations to Congress for better coordination of SMI and SED services Best practices/ebps for treatment of SMI: o Psychotropics/psychotherapies o Crisis intervention, hospital beds o CJ diversion program expansion o Peer support, Housing, Employment 48 Funding of Programs Technical Assistance Dissemination Programs

49 Ensure that grants are subject to performance and outcome evaluations: CBHSQ Data Collection: NSDUH, TEDS, GPRA, DAWN Evaluation of all SAMHSA programs Development of a standardized evaluation with specific questions related to program Begin process of OMB approval for outcome variables ahead of Funding Opportunity Announcements (FOAs) 49

50 Policy Based on Data Evaluation: National Mental Health and Substance Use Policy Laboratory Will promote evidence-based practices and service delivery models through evaluating models that would benefit from further development and through expanding, replicating, or scaling EBPs across a wider area o Main focus on SMI: particularly schizophrenia and schizoaffective disorder, as well as other serious mental illnesses o Focus on EBP and service models for substance disorders with focus on OUD Closer relationships with NIH 50

51 Assistant Secretary Priorities: SMI Early Intervention/Ongoing support: Effective medical treatment of psychosis Suicide Prevention Support for evidence-based prevention, treatment, recovery services 51 STR grants to states Block grants to states TA to states on EBPs MAT, psychotherapies, PDMP, toxicology screens Naloxone access/first Responders/Peers Pregnant/post partum women/nas Criminal justice programs Recovery Housing Training programs ATTCs, PCSS, CIHS

52 Assistant Secretary Priorities: Opioid/Other Substances Establishment of EBP in clinical practice MAT and psychosocial therapies Clinician/state government partnerships Review of SAMHSA initiatives with other substances 52

53 Workforce Development Continue SAMHSA training initiatives: o ATTCs, PCSS-type programs DATA waiver training in pre-graduate settings: o Medical, advance practice nursing, physician assistant programs Encourage national certification programs for peer workforce Encourage entry to the field through incentives: o E.g. loan forgiveness Integration of Behavior Health into primary care/fqhcs 53

54 Assistant Secretary Wish List Access to evidence-based behavioral healthcare for all in need Increase SAMHSA assistance to families of those living with SMI/SUDs Prioritize Section 8 housing for those living with SMI and recovering from SUD Eliminate criminal records for minor drug offenses Help to establish effective interventions in BH for transitional age youth Control the swing of the pendulum regarding opioid analgesic prescribing 54

55 SAMHSA s Disaster Relief Efforts Behavioral health plays an important role in disaster readiness and response Resulting from recent events, SAMHSA s role and the integration of behavioral health into disaster response has increased: Establishment of SAMHSA Liaison Officer position within Secretary s Operation Center (SOC) SAMHSA/Behavioral Health Liaison position on the Incident Response Coordination Team (IRCT) and the Joint Field Office Establishment of SAMHSA Disaster Volunteer Workgroup Grant flexibilities and enhanced technical assistance support provided to affected jurisdictions Assisted Drug Enforcement Agency to reverse policy on approval of mobile Opioid Treatment Program Services

56 2017 Prescription Drug Monitoring Program (PDMP) National Meeting 09/06/2017 to 09/08/2017

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58 SAMHSA/CARA/ PDMP According to CARA, reauthorization of funding for the National All Schedules Prescription Electronic Reporting Act for states to improve or maintain a prescription drug monitoring program (PDMP) is needed. SAMHSA s Vision which includes the statement that Prevention Works, SAMHSA finds the role of PDMPs to be of paramount importance in playing a very pivotal role in preventing substance use disorders

59 Prescription Drug Monitoring Programs (PDMPs) There have been 2 SAMHSA funding opportunities to support the development and implementation of state PDMPs FIRST SAMHSA funding opportunity was PDMP EHR Integration and Interoperability with program activity beginning in Fiscal Year SECOND SAMHSA funding opportunity was EHR & PDMP Data Integration with program activity beginning in Fiscal Year 2013 with anticipated programing to last 2 years** ** HOWEVER, THE PROGRAM WILL BE ENDING AT THE END OF THIS FISCAL YEAR (September 30, 2017) given the approval of 2 No Cost Extensions which is quite uncommon 59

60 2012 PDMP EHR Integration and Interoperability The purpose of this SAMHSA funding opportunity, was to: 1) Improve real-time access to PDMP data by integrating PDMPs into existing technologies, like EHRs, in order to improve the ability of State PDMPs to reduce the nature, scope, and extent of prescription drug abuse; and 2) Strengthen State PDMPs that are currently operational by providing resources to make the changes necessary to increase interoperability of State PDMPs.

61 2012 PDMP EHR Integration and Interoperability There were a total of 9 States that received funding, including: Indiana, Florida, Maine, Illinois, Washington State, Kansas, Texas and West Virginia and Ohio with funding for each grantee around $382,000 per year. *Grant funds were also to be used by States for modification of their systems to expand interoperability 61

62 2012 PDMP EHR Integration and Interoperability It was anticipated that Grant funds would enable States to integrate their PDMPs into EHR and other health information technology systems to expand utilization by increasing the production and distribution of unsolicited reports and alerts to prescribers and dispensers of prescription data.

63 2013 EHR & PDMP Data Integration grant The PURPOSE to: (2 years) 1) REDUCE prescription drug misuse and abuse by providing healthcare providers with access to PDMP data to make sound clinical decisions without disturbing their regular clinical workflow. 2) PROVIDE resources to states to enable hospital emergency department EHRs, primary care facility EHRs, and retail store pharmacy dispensing systems to link electronically to PDMPs in order to facilitate increased utilization AND foster the ability of states to reduce the nature, scope, and extent of prescription drug abuse 63

64 2013 EHR & PDMP Data Integration grant (2 years) : Expectations 1) IMPROVED the quality of prescription drug information available to healthcare providers by integrating PDMP data into existing technologies, e.g., EHRs, Health Information Exchanges (HIEs); and 2) SUPPORTED real-time access to prescription drug information by integrating PDMP data into existing clinical workflows.

65 2013 EHR & PDMP Data Integration grant (2 years) There were a total of 7 States (ALL DIFFERENT STATES from prior PDMP FOA) that received funding, including: Kentucky, New York, North Dakota, Rhode Island, South Carolina, Wisconsin & Massachusetts with funding for each grantee averaging around $362,00 per year. 65

66 2013 EHR & PDMP Data Integration grant (2 years) *Grant funds are anticipated to have assisted states in addressing prescription drug misuse and abuse strategies by integrating their PDMP data into EHRs and other Health Information Technology (HIT) systems. NOTE: These grant funds could NOT be used to enhance or expand PDMPs BUT only be used for the purposes of integrating PDMP data into health information systems.

67 LESSONS LEARNED and DELAYS 1. Identification of willing PDMP Integration partners was far more difficult than expected. 2. Differing legal opinions related to the scope of the projects, resulting in a legal review that delayed the timeline for project work. 3. Significant programmatic change and subsequent delay in completion of timeline deliverables. (i.e; vendors and relevant software changes) 4. Difficulty attracting and retaining the technical staff required to progress the PDMP project resulting in significant delays in completing their project goals. 67

68 Pending SAMHSA Future PDMP Funding

69 SAMHSA: Helping People Help Themselves Thank You! 69