OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH

Remarks to the AMSUS 2018 ANNUAL MEETING

Admiral Brett P. Giroir, M.D. Assistant Secretary for Health Senior Advisor for Opioid Policy

@HHS_ASH

November 27, 2018 U.S. LIFE EXPECTANCY: 1900 - 2015

90 PUBLIC HEALTH SUCCESSES 80 • Influenza and Pneumonia

70 • Enteric Diseases

60 • Stroke and CV Disease

50 • Tuberculosis • Cancer Life Expectancy (years) 40 • Accidents 30 1900 1903 1906 1909 1912 1915 1918 1921 1924 1927 1930 1933 1936 1939 1942 1945 1948 1951 1954 1957 1960 1963 1966 1969 1972 1975 1978 1981 1984 1987 1990 1993 1996 1999 2002 2005 2008 2011 2014

https://www.cdc.gov/nchs/data-visualization/mortality-trends/index.htm OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 2 U.S. HEALTH CHALLENGES IN THE 21st CENTURY

MASS GENERAL’S INPATIENT ADJUSTED COSTS Highest global spending PER LIVE DISCHARGE on health: $3.3 trillion (17.9% of GNP)

Health care spending is predicted to reach $5.7 trillion by 2026

OFFICE OF THE Meyer GS et al. N Engl J Med 2012;366:2147-2149 ASSISTANT SECRETARY FOR HEALTH 3 U.S. HEALTH CHALLENGES IN THE 21st CENTURY • Life Expectancy - Among the 36 OECD* nations, the U.S. ranks 28th in life expectancy; 33rd in infant mortality; 32nd in suicide rate - In 2015 and 2016 life expectancy decreased in the United States • Sexually Transmitted Diseases - Highest number ever reported in U.S. in 2016; - >2 million; 50% in adolescents and young adults • Influenza and Infectious Diseases - Enhanced risks from pandemic influenza, emerging infectious diseases, anti-microbial resistance • Rogue States and Organizations - Intentional chemical, biological, radiological, and nuclear attack

*Organization for Economic Development and Cooperation OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 4 5

U.S. DRUG OVERDOSE DEATHS THE MOST CRITICAL PUBLIC HEALTH CHALLENGE OF OUR TIME

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 5 6

OVERDOSE MORTALITY BY CLASS OF DRUG ADAPTED FROM CDC STATISTICS, NOVEMBER 2018

NAT & SEMI – SYNTHETIC PSYCHO- HEROIN METHADONE COCAINE SYNTHETIC OPIOIDS STIMULANTS

APRIL 2017 * 16,345 15,405 3,419 24,234 12,565 8,787

APRIL 2018 * 15,357 14,264 3,279 30,545 14,830 11,398

Change -6.0% -7.4% -4.1% +26.0% +18.0% +29.7%

* Number of deaths for the 12 months ending in April of the indicated year.

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 6 CRITICAL ROLE OF LAW ENFORCEMENT CURBING ILLICIT IMPORTATION

. State troopers seized 118 May 25, 2018 pounds of fentanyl

Inside a truck in Nebraska, troopers found . That amount of fentanyl enough fentanyl to kill millions of people would contain enough lethal doses to potentially kill more than 26 million people

. Largest fentanyl seizure in state history and one of the largest in the United States

Nebraska State Patrol, courtesy

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 7 U.S. HEALTH CHALLENGES IN THE 21ST CENTURY

Recruits' Ineligibility Tests the Military More Than Two-Thirds of American Youth Wouldn't Qualify for June 27, 2014 Service, Pentagon Says

“…the Defense Department estimates 71% of the roughly 34 million 17- to 24-year-olds in the U.S. would fail to qualify to enlist in the military if they tried....”

Physical Fitness, Drug Abuse, Education

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 8 PREDICTED OBESITY OF TODAY’S TWO YEAR OLDS

Ward ZJ et al. N Engl J Med 2017;377:2145-2153 N Engl J Med OFFICE OF THE Volume 377(22):2145-2153, November 30, 2017 ASSISTANT SECRETARY FOR HEALTH 9 INEQUALITIES IN LIFE EXPECTANCY AMONG U.S. COUNTIES 1980 – 2014 (DWYER-LINDGREN, 2017)

• Inequalities in life expectancy among counties are large and increasing over time

• Difference in life expectancy between the lowest ranking county and the highest ranking county is 20.1 years (66.8 – 86.9 years)

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 10 GLOBAL HEALTH CHALLENGES IN THE 21st CENTURY

INFECTIOUS DISEASE Ebola Cases, DRC • Malaria: 216M cases and 445,000 deaths annually • Tuberculosis: 25% of world population infected 1.7M deaths annually • HIV/AIDS: 36.9M people infected 1.8M new cases in 2017 • Neglected Tropical Diseases: >140 diverse communicable diseases affecting the poorest 1B people on the planet (examples include Dengue, Hookworm, Schistosomiasis)

NON COMMUNICABLE DISEASE RISKS OF PANDEMICS: • Influenza, SARS, MERS, Cancer, Cardiovascular Disease, Diabetes, Chronic Lung Disease caused 37% of deaths even in low income countries Ebola, others

16,000+ Children Die Every Day of Preventable Diseases

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 11 12

HHS PRIORITIES

THE OPIOID CRISIS HEALTH INSURANCE REFORM HHS is committed to ending the HHS is working to improve crisis of opioid addiction and the availability and affordability overdose in America of health insurance

DRUG PRICING VALUE-BASED CARE HHS is determined to lower the HHS is working to transform costs of prescription drugs for all our system to one that pays Americans without discouraging for value Secretary Alex M. Azar II innovation

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 12 Assistant Senior Advisor Secretary for for Opioid Health Policy

OPPORTUNITIES TO EFFECT USPHS CHANGE World Health Commissioned Organization Corps

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 13 OASH OPPORTUNITY - Develop and coordinate the implementation of policies, investments, and frameworks to transform the current “sick-care system” into a “health-promoting system”

OPIOID POLICY OPPORTUNITY - Whole of society, evidence-based, public health approach emphasizing prevention, access, treatment of addiction as a disease, and holistic needs for successful recovery

USPHS OPPORTUNITY - Modernize the Commissioned Corps and employ it as an “agent of change” for those with the highest acute and/or chronic public health needs

WHO OPPORTUNITY - Build resilient national public health primary care systems to enhance global health security

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 14 OASH: DEVELOPING THE ROADMAP FOR A HEALTHIER NATION

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 15 BULLY PULPIT OF THE SURGEON GENERAL

VADM

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 16 SELECT OASH PRIORITY INITIATIVES

• Infectious Diseases - Reducing new cases of HIV by 50% within 5 years - Increasing HPV coverage rate to 80% within 5 years - Incentivizing adult vaccination through reimbursement reform - Developing a national plan to combat STDs

• Meeting the Physical Activity Guidelines for Americans - Developing a national plan for youth sports participation and physical activity targeting underserved communities and girls

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 17 SELECT OASH PRIORITY INITIATIVES

• Digital Determinants of Health - Developing the ethical, legal, and scientific frameworks to fully leverage social media for public health applications

• Chronic Kidney Disease - HHS wide comprehensive plan to improve the outcomes and cost of chronic renal failure • Implementing the revised “Common Rule”

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 18 SELECT OASH PRIORITY INITIATIVES

• Health Disparities - Developing Office of Minority Health programs that serve as a catalyst and new framework for change - Implementing public health “turn around teams” focused on zip codes suffering worst health inequities - Improving sudden cardiac death and availability of CPR - Developing exemplar initiatives

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 19 SICKLE CELL DISEASE NEW FEDERAL WORKING GROUP

Together with OASH and multi- sector partners, developing a national action plan for sickle cell disease

OMH’s #SickleCellStories

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 20 TOOLS AND APPROACHES

Guidelines Global Agreements Policies

Grants and Contracts Regulations

Reimbursement and Workforce

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 21 22

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH https://www.hhs.gov/opioids/ 22 23

HHS OPIOIDS STRATEGY UPDATE RELEASED SEPTEMBER 17, 2018

“The five-point HHS strategy to end the opioid crisis, unveiled under President Trump in 2017, uses the best science and evidence to directly address this public health emergency. Now, HHS is expanding the scope and improving the effectiveness of the strategy.”

Secretary

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 23 WHAT DOES EVIDENCE-BASED TREATMENT LOOK LIKE?

• FDA-approved medication (MAT)

- Naltrexone: once a month injectable medication, blocks effects of opioids; - Methadone: long acting, once-daily, opioid from specially licensed programs; - Buprenorphine/naloxone: long acting, once daily/once monthly, opioid from prescriber offices

• Psychosocial Therapies

- Education, coping skills, relapse prevention, PDMP monitoring and toxicology screening

• Recovery Services - Rebuilding One’s Life

- 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

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ACHIEVING RESULTS IN COMBATTING THE OPIOID EPIDEMIC SINCE JANUARY 2017

The total morphine milligram equivalents dispensed monthly by retail and mail-order pharmacies declined by 27.8%.

Number of unique patients receiving buprenorphine monthly from retail pharmacies increased by 21%.

The number of naltrexone prescriptions per month from retail pharmacies has increased more than 47%.

Naloxone prescriptions dispensed monthly by retail and mail-order pharmacies have increased by 367%.

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 25 1

PAIN RELIEVER USE DISORDER IS DECREASING

NSDUH, 2017 Data; published Sept. 2018

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 26 27 NATIONAL SURVEY ON DRUG USE AND HEALTH, 2017 FIRST TIME HEROIN USERS DROPPED BY >50% (2016-2017)

Past Year Heroin Initiates among People Aged 12 or Older (in Thousands): 2002-2017

OFFICE OF THE NSDUH, 2017 Data; published Sept. 2018 ASSISTANT SECRETARY FOR HEALTH 27 28

ED VISITS FOR SUSPECTED DRUG OVERDOSE (% CHANGE) Q3 2017 – Q4 2017

* 21 States Reporting * 25 States Reporting

OFFICE OF THE Source: CDC Enhanced State Opioid Overdose Surveillance Program (ESOOS) ASSISTANT SECRETARY FOR HEALTH 28 29

12 MONTH OVERDOSE MORTALITY: CDC NOVEMBER 2018

75000 HHS OPIODS TEAM GOAL: Reduce US drug overdose mortality by at least 15% (>10,000 lives annually) 70000 by January 2021

65000

12-months ending 60000 in April 2018

12 MONTH MORTALITY 55000

50000

12 MONTHS ENDING IN MONTH

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 29 30

NALOXONE: AN ESSENTIAL PART OF THE OPIOIDS SOLUTION

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 30 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%  Primary drivers of co-prescribing are states with mandatory co-prescription laws

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 31 NALOXONE PREFILLED SYRINGE OUT OF POCKET COSTS 2017

% Total Prefilled Payers Average OOP % of Rx < $10 OOP % of Rx < $20 OOP Syringe Rx WORKERS COMP - EMPLOYER $0.00 1.30% 100.00% 100.00% MODA HEALTH $0.52 1.80% 100.00% 100.00% FEDERAL EMPLOYEES/ FEHBP $3.57 6.70% 100.00% 100.00% HUMANA $4.42 1.30% 100.00% 100.00% COMMONWEALTH OF VIRGINIA (VA) $4.45 1.10% 85.70% 100.00% UNIONS-NATIONAL $4.63 2.80% 94.10% 94.10% BCBS CAREFIRST $4.93 2.00% 91.70% 100.00%

BCBS ANTHEM/WELLPOINT/WELLCHOICE $5.01 7.50% 100.00% 100.00% PROVIDENCE HEALTH SYSTEMS $6.53 1.10% 100.00% 100.00% TRICARE $6.59 9.40% 98.30% 100.00% BCBS FLORIDA (FL) $7.55 3.10% 84.20% 89.50% CIGNA $7.82 2.80% 76.50% 100.00% BCBS/THE REGENCE GROUP $8.06 1.10% 85.70% 100.00% BLUE CROSS PREMERA $9.02 2.30% 78.60% 100.00% UNITED HEALTHCARE $9.46 8.00% 79.60% 93.90% SELECT HEALTH $11.21 2.10% 84.60% 100.00% BCBS SOUTH CAROLINA (SC) $12.14 1.30% 75.00% 75.00% KAISER FOUNDATION HEALTH PLANS $12.91 4.20% 50.00% 96.20% BCBS HEALTHCARE SERVICE CORP $13.12 2.60% 50.00% 87.50% OPTIMA HEALTH (VA) $17.12 1.50% 44.40% 55.60%

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 32 NARCAN OUT OF POCKET COSTS FOR LARGEST PAYERS 2017

% of Total Narcan Payers Average OOP % Rx < $10 OOP % Rx < $20 OOP Rx WORKERS COMP - EMPLOYER $0.93 1.30% 99.90% 100.00% PRESBYTERIAN HEALTH PLAN (NM) $8.52 1.80% 95.10% 95.30% TRICARE $10.48 7.60% 97.40% 97.80% OPTIMA HEALTH (VA) $18.37 2.10% 65.10% 67.20% UNIONS-NATIONAL $20.79 2.90% 38.60% 52.20% CIGNA $21.76 4.30% 54.00% 57.70% BCBS FLORIDA (FL) $22.11 1.40% 68.10% 69.00% UNITED HEALTHCARE $23.74 5.60% 58.40% 59.60% COMMONWEALTH OF VIRGINIA (VA) $24.32 1.60% 41.10% 45.80% BCBS ANTHEM/WELLPOINT/WELLCHOICE $24.73 6.20% 40.40% 54.30% BCBS HEALTHCARE SERVICE CORP $26.04 2.80% 47.60% 60.60% BCBS NORTH CAROLINA (NC) $27.65 2.60% 60.20% 66.10% AETNA INC $28.12 4.30% 40.90% 44.90% FEDERAL EMPLOYEES/ FEHBP $28.24 7.20% 46.50% 46.90% BCBS TENNESSEE (TN) $28.75 1.20% 62.70% 63.70% BCBS MICHIGAN (MI) $29.66 1.00% 43.50% 51.80% BCBS HIGHMARK $30.65 1.00% 29.80% 40.50% BCBS CAREFIRST $34.92 1.70% 22.00% 36.90% HUMANA $35.89 0.80% 42.00% 54.60% BLUE CROSS MASSACHUSETTS $48.02 0.90% 9.80% 23.20%

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 33 MEDICARE OUT OF POCKET COSTS

• The CY 2018 Part D plan-level formulary inclusion and prior authorization (PA) rates are: - Naloxone PF syringes: on 99.3% of plan formularies, PA on 0.3% - Narcan: on 94.7% of plan formularies; no plans require PA - Evzio: on 5.9% of plan formularies; PA on 44.7%

• The average cost-sharing (excludes low income subsidy enrollment) - Naloxone PF syringes: $13.86 per syringe (copay plans) or $4.57 (coinsurance plans) - Narcan: $51 per 2 nasal sprays (copay plans) or $39.20 (coinsurance plans) - Evzio: $90 per 2 injectors (copay plans) or $1,707.65 (coinsurance plans)

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 34 U.S. PUBLIC HEALTH SERVICE COMMISSIONED CORPS

“the Commissioned Corps… a mobile, duty-bound group of health officers willing to go anywhere, at any time, to meet the nation’s most urgent public health needs.”

Craig Collins The PHS Commissioned Corps Two Centuries and Counting

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 35 36

NOTABLE DEPLOYMENTS USPHS COMMISSIONED CORPS

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 36 PUBLIC HEALTH SERVICE COMMISSIONED CORPS MODERNIZATION SELF ASSESSMENT

• Strong HHS and inter-departmental support for Commissioned Officers expertise and leadership • Between 2013 and 2018, officers deployed over 6,000 times, contributing more than 116,000 deployment-days to more than 110 missions • ~50 % of officers participated in intra-agency response missions since 2016 • Projected increase demand for officers: deployments and agency missions • Persistent provider shortages for underserved and vulnerable populations of up to 25% could be best filled by officers

A bold strategic vision to enhance the capabilities, responsiveness, mission set, and focus of our service

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 37 38

VISION FOR A 21st CENTURY COMMISSIONED CORPS

. A highly-trained, always-ready, fully-deployable national asset to preserve public health and national security during national or global public health emergencies

. A fundamental instrument of national response for non-emergent, yet critical, public health challenges within the United States and territories

. A provider of direct health care, public health leadership, and scientific expertise when specifically needed to fulfill U.S. Government requirements

. An innovation engine for public health technologies, communications, systems, and systems of systems

MISSION DRIVES THE REQUIREMENTS; REQUIREMENTS DRIVE THE FORCE STRUCTURE

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 38 PUBLIC HEALTH INNOVATION CONTEXT AND CONTINUUM

BASIC TRANSFORMATIONAL TEST AND DISSEMINATION RESEARCH APPLICATIONS EVALUATION AND ADOPTION

DARPA: High risk early and USPHS Commissioned HHS Operational Divisions: NIH intermediate development Corps: CMS, HRSA, CDC, (tech and capabilities SAMHSA, others NSF push) • Deployments and PHEs • Public health turnaround Federal Partners (VA, DoD) BARDA: Intermediate and NGOs teams and missions advanced development Integrated Health Systems Biotech within authorized areas • Clinical care in under- served and rural NGOs, WHO, and environments Accelerating Clinical international partners Innovation: Clinical needs and opportunities Military Medicine pull; systems demonstrations

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 39 PRIORITIES FOR PUBLIC HEALTH INNOVATION

• Orthogonal technologies and paradigms for the current most costly medical issues (for example, hemodialysis, falls, sepsis, pain)

• Technologies and approaches that allow for more advanced care outside of hospital settings including in rural environments (strong synergy with military medicine)

• Socio-behavioral approaches and distributive technologies to transform the current “sick care system” into a “health promoting system”

• Big data, social networks, and digital platforms for public health, including epidemiology, prediction, prevention, and treatment

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 40 PRIORITIES FOR PUBLIC HEALTH INNOVATION

• Models to minimize U.S. regional health disparities

• End U.S. infectious disease epidemics within our technical control: HIV, HCV, HPV, influenza

• Integration of genetic cures and immunotherapies as cornerstones of the health care system

• Developing a new paradigm for understanding and treating neurodegeneration

• Global health security: an endogenous global capacity, early warning, detection, diagnosis, rapid mitigation, and assured effective response

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 41 WHERE WILL WE STAND ON BEHALF OF PUBLIC HEALTH?

“We started assembly today” Orville Wright’s Diary “The flying machine October 9, 1903 which will really fly might be evolved by the combined and continuous efforts of mathematicians and mechanicians in from one million to ten million years”

October 9, 1903

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH 42 WWW.HHS.GOV/ASH BRETT P. GIROIR, M.D. WWW.USPHS.GOV ADM, U.S. Public Health Service Assistant Secretary for Health, Senior Advisor for Opioid Policy @HHS_ASH [email protected]

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