OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH HHS

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OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH HHS PRIORITIES ON HIV AND SUBSTANCE USE

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH HHS PRIORITIES ON HIV AND SUBSTANCE USE PRESENTED TO THE BIG CITIES HEALTH COALITION March 12, 2019 ADMIRAL BRETT P. GIROIR, M. D. Assistant Secretary for Health and Senior Advisor for Opioid Policy

NEW HIV DIAGNOSES HAVE DECLINED SUBSTANTIALLY BUT PROGRESS IS STALLED MAJOR PROGRESS • 1980

NEW HIV DIAGNOSES HAVE DECLINED SUBSTANTIALLY BUT PROGRESS IS STALLED MAJOR PROGRESS • 1980 s peak incidence near 130, 000 annually 40, 324 diagnoses in 2016 • 1985 - 2012 interventions have driven infections down to <50, 000 annually www. cdc. gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-23 -4. pdf 2 2

48 COUNTIES, 7 STATES WITH SUBSTANTIAL RURAL HIV BURDEN, DC AND SAN JUAN ACCOUNT

48 COUNTIES, 7 STATES WITH SUBSTANTIAL RURAL HIV BURDEN, DC AND SAN JUAN ACCOUNT FOR 50% OF NEW DIAGNOSES County contributing to 50% new HIV diagnoses in 2016 / 2017 State with disproportionate rural burden in 2016 / 2017 3 3

HIV DIAGNOSES ACROSS SPECIFIC GROUPS * In 2016, African Americans accounted for 44% of

HIV DIAGNOSES ACROSS SPECIFIC GROUPS * In 2016, African Americans accounted for 44% of HIV diagnoses, but comprised 12% of U. S. population From 2012 -2016, HIV diagnoses among Hispanic/Latino MSM age 25 -34 years increased 22% From 2012 -2016, HIV diagnoses among American Indian / Alaska Native MSM increased 58% * www. cdc. gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-23 -4. pdf, all other data from https: //www. cdc. gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2017 -vol-29. pdf 44

EARLY DIAGNOSIS IS ESSENTIAL TO END THE HIV EPIDEMIC § 1 in 2 people

EARLY DIAGNOSIS IS ESSENTIAL TO END THE HIV EPIDEMIC § 1 in 2 people with HIV have the virus at least 3 years before diagnosis § 1 in 4 people with HIV have the virus at least 7 years before diagnosis § 1 in 5 people with HIV are diagnosed with advanced disease (AIDS) § 7 in 10 people with HIV saw a healthcare provider in the 12 months prior to diagnosis and failed to be diagnosed 87% of new HIV infections are transmitted from people who don’t know they have HIV or are not retained in treatment Daily et al. , MMWR Weekly Report, 2017; Skarbinski et al. , JAMA, 2015; Gopalappa et al. , Med Decision Making, 2017 5 5

THE TIME IS NOW: RIGHT DATA, RIGHT TOOLS, RIGHT LEADERSHIP § Epidemiology - §

THE TIME IS NOW: RIGHT DATA, RIGHT TOOLS, RIGHT LEADERSHIP § Epidemiology - § Antiretroviral Therapy - § FDA-approved and highly effective drug to prevent HIV infections Proven Models of Effective Care and Prevention - § Highly effective, saves lives, prevents sexual transmission; increasingly simple and safe Pre-exposure Prophylaxis (Pr. EP) - § Most new HIV infections are clustered in a limited number of counties and specific demographics 25 years' experience engaging and retaining patients in effective care Detect and Respond Strategy - There is a real risk of HIV exploding again in the U. S. due to several factors including injection drug use and diagnostic complacency among healthcare providers Extensive surveillance infrastructure in place, rapid detection and response capacity increasing 6 6

ENDING THE HIV EPIDEMIC: A PLAN FOR AMERICA FOCUSED EFFORT • 48 Counties, DC,

ENDING THE HIV EPIDEMIC: A PLAN FOR AMERICA FOCUSED EFFORT • 48 Counties, DC, and San Juan account for 50% of new infections • 7 States with substantial rural HIV burden O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 7

IMPLEMENTATION PLAN § Target focus initially on high incidence geographies - § Emphasize early

IMPLEMENTATION PLAN § Target focus initially on high incidence geographies - § Emphasize early diagnosis, immediate treatment, engagement - § Treat diagnosed persons rapidly to achieve viral suppression and stop transmission Increase viral suppression from 50% to 90%: HRSA Ryan White has achieved 85% Expand pre-exposure prophylaxis (Pr. EP) - § Target 48 counties, DC and San Juan that account for 50% of diagnoses Target select states with high rural HIV burdens to establish effectiveness in rural environment Increase use by at-risk population from 10% to at least 50% Rapid and overwhelming response to HIV outbreak clusters - Monitor for early detection of clusters Treat each new diagnosis as a “sentinel event” 8 8

PRESIDENT’S 2020 BUDGET PROPOSAL DISCRETIONARY INVESTMENTS (+$291 MILLION) AGENCY ACTIVITY NEW $$ CDC •

PRESIDENT’S 2020 BUDGET PROPOSAL DISCRETIONARY INVESTMENTS (+$291 MILLION) AGENCY ACTIVITY NEW $$ CDC • • Test and link persons to treatment; state and local support; surveillance Augmentation of public health staff in local jurisdictions $140 M HRSA • • Ryan White care centers for treatment Community health centers for prevention, emphasizing Pr. EP $70 M $50 M IHS • Enhanced support for prevention, diagnosis, and links to treatment $25 M NIHCFARs • Inform HHS and partners on evidence-based practices and effectiveness $6 M • Project coordination, communication, management, and accountability; Leadership of the Minority AIDS Initiative Maintains current $ • Minority AIDS Program and Substance Abuse Prevention and Treatment Block Grants for HIV/AIDS prevention for those with Substance Abuse or Mental Illness Maintains current $ OASH SAMHSA 9 9

O F F I C E O F T H E ASSISTANT SECRETARY FOR

O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH https: //www. hhs. gov/opioids/ 10 10

ED VISITS FOR SUSPECTED DRUG OVERDOSE (% CHANGE) Q 2 2017 – Q 2

ED VISITS FOR SUSPECTED DRUG OVERDOSE (% CHANGE) Q 2 2017 – Q 2 2018 Male Female 0 ALL DRUGS* ALL OPIOIDS* 0 -2 -4 -3. 73 -6 -8 -2 -10 -9. 47 -12 -4 -13. 66 -16 -6 -15. 57 -18 -6. 72 -8 11 -24 25 -34 35 -54 55 and up 0 -10 -5 -12 -10 -14 -7. 39 -9. 08 -15 -14. 63 -16 * 24 States * 22 States O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH -4. 38 -4. 79 -4. 86 -13. 1 -15. 54 -20 -25 -21. 61 Source: CDC Enhanced State Opioid Overdose Surveillance Program (ESOOS) 11

ROLLING 12 MONTH DRUG OVERDOSE MORTALITY (PREDICTED) THROUGH JULY 2018 HHS OPIOIDS TEAM GOAL

ROLLING 12 MONTH DRUG OVERDOSE MORTALITY (PREDICTED) THROUGH JULY 2018 HHS OPIOIDS TEAM GOAL Reduce US drug overdose mortality by at least 15% (>10, 000 lives annually) by January 2021 12 -months ending in July 2018 O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH Source: CDC National Vital Statistics System, retrieved February 15, 2019 12 12

January February March April May June July August September October November December January February

January February March April May June July August September October November December January February March April May June July % Change in Numbers of Drug Overdose Deaths District of Columbia Percent Change in Deaths (since Jan 2015) 250% 200% 150% 100% 50% 0% N=115 2016 2017 2018 N=291

January February March April May June July August September October November December January February

January February March April May June July August September October November December January February March April May June July % Change in Numbers of Drug Overdose Deaths Ohio Percent Change in Deaths (since Jan 2015) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% -10% N=2836 2015 2016 2017 2018 N=4162

January February March April May June July August September October November December January February

January February March April May June July August September October November December January February March April May June July % Change in Numbers of Drug Overdose Deaths Pennsylvania Percent Change in Deaths (since Jan 2015) 120% 100% 80% 60% 40% 20% 0% N=2897 2015 2016 2017 2018 N=4959

January February March April May June July August September October November December January February

January February March April May June July August September October November December January February March April May June July % Change in Numbers of Drug Overdose Deaths New York Percent Change in Deaths (since Jan 2015) 80% 70% 60% 50% 40% 30% 20% 10% 0% N=1573 2015 2016 2017 2018 N=2376

N=2648 January February March April May June July August September October November December January

N=2648 January February March April May June July August September October November December January February March April May June July % Change in Numbers of Drug Overdose Deaths Texas Percent Change in Deaths (since Jan 2015) 20% 15% 10% 5% 0% -5% 2015 2016 2017 2018 N=3039

N=1113 January February March April May June July August September October November December January

N=1113 January February March April May June July August September October November December January February March April May June July % Change in Numbers of Drug Overdose Deaths Missouri Percent Change in Deaths (since Jan 2015) 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% -5% -10% 2015 2016 2017 2018 N=1537

January February March April May June July August September October November December January February

January February March April May June July August September October November December January February March April May June July % Change in Numbers of Drug Overdose Deaths California Percent Change in Deaths (since Jan 2015) 16% 14% 12% 10% 8% 6% 4% 2% 0% -2% N=4766 2015 2016 2017 2018 N=5445

January February March April May June July August September October November December January February

January February March April May June July August September October November December January February March April May June July % Change in Numbers of Drug Overdose Deaths Illinois Percent Change in Deaths (since Jan 2015) 80% 70% 60% 50% 40% 30% 20% 10% 0% N=1661 2015 2016 2017 2018 N=2925

January February March April May June July August September October November December January February

January February March April May June July August September October November December January February March April May June July % Change in Numbers of Drug Overdose Deaths Massachusetts Percent Change in Deaths (since Jan 2015) 60% 50% 40% 30% 20% 10% 0% N=1579 2015 2016 2017 2018 N=2452

WHAT IS EVIDENCE-BASED TREATMENT? FDA-approved Medication (MAT) - Education, coping skills, contingency management and

WHAT IS EVIDENCE-BASED TREATMENT? FDA-approved Medication (MAT) - Education, coping skills, contingency management and cognitive behavioral therapy Recovery Services - Rebuilding One’s Life - Buprenorphine/naloxone: long acting, once daily/once monthly, opioid from doctor’s offices (Waivered prescribers) Psychosocial Therapies - Naltrexone: once a month injectable medication, blocks effects of opioids (Any prescriber) Methadone: long acting, once-daily, opioid from specially licensed programs (OTP programs only) Social supports to welcome into a healthy community: family, friends, peers, faith-based supports Assistance with needs that can impact treatment - recovery housing, transportation and child care Employment/Vocational training/education Naloxone O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 22

BIG CITIES HEALTH COALITION SELECT POLICY RECOMMENDATIONS • • • Eliminate waiver and training

BIG CITIES HEALTH COALITION SELECT POLICY RECOMMENDATIONS • • • Eliminate waiver and training Increase availability of naloxone § Federal government bulk purchase § Allow over the counter access Support Good Samaritan laws Increase fentanyl testing strips Shield localities implementing “safer injection sites” Appropriate federal funds to support comprehensive syringe service sites Ensure federal dollar reach localities Increase federal resources for iv drug-related outbreaks Promote use of prescribing guidelines O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 23 23

CLINICIANS RECENTLY WAIVERED FOR BUPRENORPHINE PRESCRIBE BELOW THEIR LIMIT OR NOT AT ALL •

CLINICIANS RECENTLY WAIVERED FOR BUPRENORPHINE PRESCRIBE BELOW THEIR LIMIT OR NOT AT ALL • Survey: 4225 clinicians receiving data waiver or increase in authorized patient limit in 2017 • Main Findings - • Only 75% had prescribed buprenorphine since obtaining the waiver Mean number of patients treated in past month = 26. 6 Clinicians prescribing at or near their limit = 13. 1% Barriers to prescribing buprenorphine at or near limit - Lack of patient demand = 19. 4% Time constraints in practice = 14. 6% Insurance requirements = 13. 2% O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH Jones and Mc. Cance-Katz. Addiction, Sept 8, 2018 24

SUPPORT ACT Section 3201. Allowing for more flexibility with respect to medication-assisted treatment for

SUPPORT ACT Section 3201. Allowing for more flexibility with respect to medication-assisted treatment for opioid use disorders. Increases the number of waivered health care providers that can prescribe or dispense MAT by authorizing clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists to prescribe MAT for five years. It also makes permanent the prescribing authority for physician assistants and nurse practitioners and allows waivered practitioners to immediately treat 100 patients at a time if the practitioner is board certified in addiction medicine or addiction psychiatry; or if the practitioner provides MAT in a qualified practice setting. Codifies the ability for qualified physicians to prescribe MAT for up to 275 patients. The Secretary of HHS, in consultation with the Drug Enforcement Administration, will be required to submit a report that assesses the care provided by physicians treating over 100 patients and non-physician practitioners treating over 30 patients. Section 3202. Medication assisted treatment for recovery from substance use disorder Ensures physicians who have recently graduated in good standing from an accredited school of allopathic or osteopathic medicine, and who meet the other training requirements to prescribe MAT, to obtain a waiver to prescribe MAT. O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 25 25

BIG CITIES HEALTH COALITION SELECT POLICY RECOMMENDATIONS • • • Eliminate waiver and training

BIG CITIES HEALTH COALITION SELECT POLICY RECOMMENDATIONS • • • Eliminate waiver and training Increase availability of naloxone § Federal government bulk purchase § Allow over the counter access Support Good Samaritan laws Increase fentanyl testing strips Shield localities implementing “safer injection sites” Appropriate federal funds to support comprehensive syringe service sites Ensure federal dollar reach localities Increase federal resources for iv drug-related outbreaks Promote use of prescribing guidelines O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 26 26

NALOXONE: AN ESSENTIAL PART OF THE OPIOIDS SOLUTION O F F I C E

NALOXONE: AN ESSENTIAL PART OF THE OPIOIDS SOLUTION O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 27 27

BYSTANDER PRESENCE AND NALOXONE Significant Opportunity for Improvement 11, 884 OPIOID DEATHS (CDC ESOOS

BYSTANDER PRESENCE AND NALOXONE Significant Opportunity for Improvement 11, 884 OPIOID DEATHS (CDC ESOOS Data, 11 States, July 2016 – June 2017) PRESCRIPTION OPIOIDS (%) ILLICIT OPIOIDS (%) PRESCRIPTION AND ILLICIT OPIOIDS (%) In Category 17. 4 58. 7 18. 5 Previous OD 9. 3 15. 1 13. 5 Bystander present 41. 6 44. 0 45. 0 Bystander naloxone administration 0. 8 4. 3 4. 4 O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH Mattson et al. , MMWR, Aug 31, 2018 28

LACK OF NALOXONE CO-PRESCRIBING TO PATIENTS AT RISK • PDX, Inc - • April

LACK OF NALOXONE CO-PRESCRIBING TO PATIENTS AT RISK • PDX, Inc - • April – June 2018 (verbal report to HHS) 8600 pharmacies nationwide For patients on MME > 50, rate of naloxone co-prescribing was 0. 3% For those prescribed naloxone, 40% never picked up prescription MEDICARE, 2017 - MME > 50: rate of naloxone co-filling was 1. 3% MME = 90 – 120: rate of naloxone co-filling was 1. 6% MME > 120: rate of naloxone co-filling was 5. 2% ü Primary drivers of co-prescribing are states with mandatory co-prescription laws O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 29

HHS RECOMMENDATION: PRESCRIBE NALOXONE TO ALL PATIENTS AT HIGH RISK OF OPIOID OVERDOSE December

HHS RECOMMENDATION: PRESCRIBE NALOXONE TO ALL PATIENTS AT HIGH RISK OF OPIOID OVERDOSE December 19, 2018 Assistant Secretary for Health Guidance Prescribe or co-prescribe naloxone to individuals at risk for opioid overdose including individuals who - are on relatively high doses of opioids • Reinforces and expands upon prior CDC guidelines • Clinicians should also educate patients and those who are likely to respond to an overdose, including family members and friends, on when and how to use naloxone in its variety of forms O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH - take other medications which enhance opioid complications - have underlying health conditions https: //www. hhs. gov/opioids/sites/default/files/2018 -12/ naloxone-coprescribing-guidance. pdf 30

NALOXONE MARKET AND AFFORDABILITY Naloxone (units) List Price $4100 Evzio (2) +600% (2014) Evzio

NALOXONE MARKET AND AFFORDABILITY Naloxone (units) List Price $4100 Evzio (2) +600% (2014) Evzio (2) Generic Federal Supply Schedule Federal Market 2018 State governments, first responders, health departments 6% Much lower 1% $178 (12/18 – current) $178 N/A (mid-2019) $154 Pre-Filled Syringes (10) +635% (2010) $125 NARCAN Nasal Spray (2) O F F I C E Pharmacy Dispensed Market 2018 +0% (2015) O F <1% $132. 96 3% 94% Lower 96% $75. 38 T H E ASSISTANT SECRETARY FOR HEALTH 31

NALOXONE OVER THE COUNTER ACCESS FDA Statement, January 17, 2017 Statement from FDA Commissioner

NALOXONE OVER THE COUNTER ACCESS FDA Statement, January 17, 2017 Statement from FDA Commissioner Scott Gottlieb, M. D. , on unprecedented new efforts to support development of overthe-counter naloxone to help reduce opioid overdose deaths O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 32 32

BIG CITIES HEALTH COALITION SELECT POLICY RECOMMENDATIONS • • • Eliminate waiver and training

BIG CITIES HEALTH COALITION SELECT POLICY RECOMMENDATIONS • • • Eliminate waiver and training Increase availability of naloxone § Federal government bulk purchase § Allow over the counter access Support Good Samaritan laws Increase fentanyl testing strips Shield localities implementing “safer injection sites” Appropriate federal funds to support comprehensive syringe service sites Ensure federal dollar reach localities Increase federal resources for iv drug-related outbreaks Promote use of prescribing guidelines O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 33 33

SAMHSA UPCOMING FUNDING OPPORTUNITIES § State Opioid Response (state level by statute) - Expands

SAMHSA UPCOMING FUNDING OPPORTUNITIES § State Opioid Response (state level by statute) - Expands and enhances existing efforts in states to develop and implement systems to support opioid use disorder prevention, treatment and recovery ($500 million) § Substance Abuse and Prevention Block Grants (state level by statute) § Provider Clinical Support Services for MAT (currently announced) - Trains providers on prescribing buprenorphine § First Responder - Provides communities, states and tribes funding to purchase and distribute naloxone and implement strategies on its use § Building Communities of Recovery - Supports peer recovery support services which are used in concert with clinical treatment services to ensure access to comprehensive systems of care O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 34

HHS CROSS CUTTING INITIATIVES INITIATIVE OBJECTIVE HEALing Communities NIH, SAMHSA, HRSA, ACF, CMS, Reduce

HHS CROSS CUTTING INITIATIVES INITIATIVE OBJECTIVE HEALing Communities NIH, SAMHSA, HRSA, ACF, CMS, Reduce overdose fatalities by 40% in 3 years across ASPE, AHRQ, OASH, CDC; DOJ, communities highly affected by the opioid crisis HUD, Education Indication-Specific Opioid Prescribing Guidelines Develop and implement indication-specific best practices for opioid prescribing by 2021 CDC, AHRQ, NIH, OASH, CMS, FDA, IHS, SAMHSA Opioid Rapid Response Public Health Teams Establish health “strike teams” to ensure that following a DOJ intervention, 100% of patients have a warm-handoff to a provider. CDC, Commissioned Corps, Departments of Justice, SAMHSA Technological Solutions to Prevent Overdose Mortality Develop and evaluate at least one wearable device that overdose mortality by 2021 BARDA/ASPR, NIH, HHS CTO, DARPA Transforming the US Healthcare Workforce Define a novel model(s) for behavioral healthcare HRSA, SAMHSA, CMS, ASPE, IHS, delivery, and increase providers by net 8000 by 2021 CDC, AHRQ, CDC O F F I C E O F AGENCIES T H E ASSISTANT SECRETARY FOR HEALTH 35

MATERNAL OPIOID MISUSE (MOM) MODEL Maternity and Infant Care Behavioral Health and Primary Care

MATERNAL OPIOID MISUSE (MOM) MODEL Maternity and Infant Care Behavioral Health and Primary Care OUD Treatment State Medicaid Agency O F F I C E O F The MOM model is a patient-centered, service-delivery model, which aims to improve the quality of care and reduce costs for pregnant and postpartum Medicaid beneficiaries with OUD and their infants through statedriven care transformation. GOALS 1. Improve quality of care and reduce costs 2. Expand access to treatment, service-delivery capacity, and infrastructure 3. Create sustainable coverage and payment strategies Notice of funding opportunity release: early 2019 / Application period: Spring 2019 $64. 5 M available for state awardees over five-year model T H E ASSISTANT SECRETARY FOR HEALTH 36

BIG CITIES HEALTH COALITION SELECT POLICY RECOMMENDATIONS • • • Eliminate waiver and training

BIG CITIES HEALTH COALITION SELECT POLICY RECOMMENDATIONS • • • Eliminate waiver and training Increase availability of naloxone § Federal government bulk purchase § Allow over the counter access Support Good Samaritan laws Increase fentanyl testing strips Shield localities implementing “safer injection sites” Appropriate federal funds to support comprehensive syringe service sites Ensure federal dollar reach localities Increase federal resources for iv drug-related outbreaks Promote use of prescribing guidelines O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 37 37

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH Leading America to Healthier Lives • Providing

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH Leading America to Healthier Lives • Providing trusted data and information to serve HHS, the federal government, states and localities, and the public in general • Convening partners federal agencies, state and local, professional societies, non-profits, academia, patient advocates • Developing novel initiatives Gaining situational awareness, identifying gaps, building teams, setting a common agenda, and supporting infrastructure O F F I C E O F T H E ASSISTANT SECRETARY FOR HEALTH 38

BRETT P. GIROIR, M. D. ADM, U. S. Public Health Service Assistant Secretary for

BRETT P. GIROIR, M. D. ADM, U. S. Public Health Service Assistant Secretary for Health, Senior Advisor for Opioid Policy O F F I C E O F WWW. HHS. GOV/ASH WWW. USPHS. GOV @HHS_ASH ASH@hhs. gov T H E ASSISTANT SECRETARY FOR HEALTH 39