National Prescription
Drug Abuse Prevention
Policy Meeting
Tuesday, December 2, 2014
COMMERCIAL SUPPORTERS
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Objectives
• Information sharing
– Unique perspectives
– Contextual analysis
• Policy discussion and consensus (lowest
common denominator)
• Planning
– Maximize use of limited resources
– Harmonize efforts
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Methods
• Participant presentations
– Accomplishments
– Policy priorities
• Presentations, Q&A
• Networking
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Themes
• Progress [2013]
• Evolution of the epidemic [2013]
• Evaluation of policy
– Expand and enhance for greater impact
– Refine to address unintended consequences
• Access to care
• Core values
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Federal Policy Activity
•
•
•
•
•
•
•
•
Secure and Responsible Drug Disposal Act (effective 10/9/14)
Abuse-deterrent opioids (guidance, approval, and labeling)
FDA approved naloxone auto-injector
New opioid labels (“severe enough”) and post-market study
requirements
DEA enforcement (distributors, pharmacies, prescribers, FedEx,
and NFL) and prosecutions
Hydrocodone rescheduling
Grant support (PMPs and research)
LA/ER opioid REMS (voluntary education)
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
State Responses to Opioid Abuse
• Mandatory prescriber education – should cover all
controlled substances, differential diagnosis,
interventions/referrals, and fraud
• Mandatory PMP data checks
• Good Samaritan, naloxone laws – first responders, Rx
• Pain clinic registration and regulation
• Safer prescribing and abuse-prevention standards
• Prosecutions
– Second-degree murder (knowing indifference to consequence)
– Involuntary manslaughter (harmful activity w/o due caution)
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Progress
• CDC reported 5% decline in opioid-related overdose deaths
between 2011 and 2012, the first decline since 1999 (10/15/14)
• Overdose deaths from opioids fall 27% in Washington (1/28/14)
• Prescription drug deaths falling across Florida (10/14/13)
• National survey shows reduced levels of Rx abuse among young
adults (9/4/13)
• Kentucky sees decline in drug overdose deaths, including Rx
overdose (8/8/13)
• Opioid medication abuse down in 10 states (KY, LA, MA, MS,
NH, NY, OH, OK, RI, WV) (1/8/13)
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Evolution of the Epidemic
• Reduced supply of opioid medications available for abuse
and inadequate reduction in demand contribute to
increased use of heroin and misuse of buprenorphine
• Benzodiazepine and stimulant abuse
• Counterfeits, analogs, and new delivery systems and
manufacturing processes
• Shifting tactics of dirty docs
– From pill mills to black market biologics (created by biological
processes)
– Waste, fraud, and abuse in testing for substance use
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Building on Progress:
Accomplishments and Priorities
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Brief Introductions
• Name
• Organization
• 2014 Accomplishments
• 2015 Priorities
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Updating the National Strategy
• 2011-12 National Strategy was endorsed by
30+ not-for-profit organizations
• 2015 update in draft form
• Themes and topics discussed at Policy
Meeting
• Seeking feedback, endorsements, and quotes
– Embargoed draft at claad.org/2015ns
– January release
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
National Strategy Topics
•
•
•
•
•
•
•
•
Community coalitions and recovery communities
Data collection and analysis
Interventions and treatment
Professional education
New technologies
Restrictions on coverage
Safe storage and responsible disposal
Waste, fraud, and abuse
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Break
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Evaluating Policy
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Women and Newborns: A More
Therapeutic Approach
Stacey Worthy, Esq.
Associate Attorney
DCBA Law & Policy
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Pregnant Women and Substance Use
• Rx drug abuse epidemic affects all ages and
demographics
• Impacts health and safety of mother and child
• Low rates of use (5.4%), but consequences
are severe
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Neonatal Abstinence Syndrome
• Definition: group of problems due to opioid
exposure in the womb
– Other substances: alcohol, barbiturates,
amphetamines, cocaine, marijuana, etc.
• Symptoms: fever, irritability, poor feeding,
rapid breathing, seizures, sleep problems,
slow weight gain, tremors, etc.
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Statistics
• Significant increases in newborns with NAS
• Tripled over the past 10 years
– >5 of every 1,000
– 200,000 per year
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Barriers to Treatment
• Barriers: stigma, punitive laws & policies
• Detection and punishment policies:
– Surveillance-oriented drug testing
– Arrest
– Prosecution
– Incarceration
– Loss of custody
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Theories of Prosecution
• Child abuse in 17 states
• Involuntary commitment in 3 states
• Mandatory reporting laws in 19 states
• Child protection laws apply to unborn fetuses
in 2 states
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Tennessee Cases
• Criminalized substance use during pregnancy
– Assault
– “Narcotics” narrowly defined, broadly applied
• At least 4 arrests between July and
November
– Law may deter care: mother gave birth roadside
and failed to take newborn to hospital
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Arguments Against Punitive Laws
• Not effective deterrent b/c SUD is an illness
• Cause distrust of health care providers
• Disincentive to seek prenatal care
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Treatment
• Comprehensive treatment and recovery
services
• MAT is effective
• Retain mother-child relationship & custody
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
States with Non-Punitive Laws
• 25 states give priority access to treatment
• Florida task force
• Ohio pilot program
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Conclusion
• For more information, see:
– NAMSDL’s Commentary: State Responses to
Increasing Rates of Neonatal Abstinence Syndrome:
Alternatives to Prosecution and Incarceration
•
•
•
•
•
CLAAD.org
LinkedIn.com/in/staceyworthy
DCBALaw.com
Thank You
Questions and Discussion
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Mitigating Unintended
Consequences Part 1
Michael C. Barnes, Esq.
Executive Director
Center for Lawful Access and Abuse Deterrence
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Access to Care:
Controlled Substance Regulation
• Regulatory role fulfilled using law enforcement tactics
–
–
–
–
Drug distributors
Pharmacies
Controlled substance prescribers
FedEx and NFL
• Fear of prescribing controlled substances
• Denials of medications – even for addiction – at
pharmacies
• H.R. 4709 and S. 2862 would provide for corrective action
plans
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Access to Care:
Medication-assisted Treatment
• DATA 2000: 30/100 patient limit for
buprenorphine treatment (opioid dependence)
– Waiting lists
– Prescribers compelled to abandon patients
– Increasing demand on black market
• Petition to HHS to raise the limit
• Federal legislation
– “Omnibus” coalition bill
– S. 2646 (Markey bill)
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Access to Care: Payer Policies
• Payer policies enable waste, fraud, and abuse in
testing for substance use
– Outmoded, inaccurate technology
– Duplication of services
• Payer responses to waste, fraud, and abuse
yield further limits on access
– Restrictions on coverage
– Labs forced to question professional discretion
• Medicare contractor: bundle 40+ for a flat fee
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Protecting Core Values: Compassion
• Jailing moms and seizing newborns in
response to NAS
• Denials of medications
– Pain
– Anxiety, sleeplessness, ADHD
– Addiction
• Waiting lists for treatment
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Federal Policy Update
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Federal Update:
“Ensuring Patient Access to Effective
Drug Enforcement Act”
(H.R. 4709/S. 2862)
Kristen LaRose Freitas
Senior Director, Federal Government Affairs
HDMA
Controlled Substances Act (CSA)
of 1970
•Manufacturers
•Distributors/Wholesalers
•Pharmacies
•Prescribers
Prescription Drug Abuse
• Numerous bills introduced to address various
aspects of the issue – PDMPs, Education, etc.
• Specifically, patients challenges with filling
prescriptions for opioids for the management
of pain and treatment of addiction
– “Making the Pharmacy Crawl” – Wall Street Journal
(September 29, 2012)
– “Prescription painkiller crackdown has gone ‘way too far,’
some doctors believe” – Tampa Bay Times (September 1,
2014)
H.R. 4709/S. 2862
• Clarifies existing authorities under the CSA –
defines “imminent danger”
• Requires enforcement escalation process
(Corrective Action Plan)
• Requires a Report to Congress on the impact
of enforcement activities and opportunities
for agency and stakeholder collaboration
H.R. 4709
• Introduced by Reps. Marino (R-Pa.), Blackburn
(R-Tenn.), Welch (D-Vt.) and
Chu (D-Calif.)
• Jointly Referred to:
• Energy and Commerce Committee
• Judiciary Committee
• Passed the House by voice vote on July 29,
2014
S. 2862
•Introduced by Sens. Hatch (R-Utah)
and Whitehouse (D-R.I.)
•Referred to Senate Health,
Education, Labor and Pensions
Committee
Supporters
•
•
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•
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•
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•
•
American Academy of Pain Management
American Pharmacists Association
Center for Lawful Access and Abuse Deterrence
The Center for Practical Bioethics and PAINS
Compassion & Choices
Healthcare Distribution Management Association
Hospice and Palliative Nurses Association
National Fibromyalgia & Chronic Pain Association
National Association of Chain Drug Stores
National Community Pharmacists Association
Virginia Cancer Pain Initiative
U.S. Pain Foundation
Outlook for 114th Congress
Legislation will need to be reintroduced
Timing?
Opposition?
Questions?
Kristen LaRose Freitas
Senior Director, Federal Government Affairs
Healthcare Distribution Management Association
703-787-0000
kfreitas@hdmanet.org
“Omnibus” Draft Legislation
Kyle Simon
Director of Policy and Advocacy
Center for Lawful Access and Abuse Deterrence
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
“Omnibus” Draft Legislation (1/6)
• Bipartisan U.S. Senate HELP Committee
Prescription Drug Abuse Working Group
formed April 2014
• Examine ways to reduce Rx abuse
– Characteristics and challenges
– Consider government, public health groups,
providers, and law enforcement activities
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
“Omnibus” Draft Legislation (2/6)
• Pain Care Forum of 60+ organizations rose
to the occasion and drafted wish list
• 12 recommendations for federal government
to impact prescription drug abuse epidemic
• Draft online at claad.org/omnibus
• Presented to HELP Committee staff in
October; next steps with GOP control?
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
“Omnibus” Draft Legislation (3/6)
1. Strengthen prescription monitoring programs
– Interoperability
– NASPER reauthorization
2. Regulate before raiding
– Healthcare distribution supply chain raided by
DEA without clear guidelines for compliance
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
“Omnibus” Draft Legislation (4/6)
3. Specialty certification for opioid prescribers
4. Repeal Institution for Mental Diseases
exclusion for substance use disorder
treatment
– Medicaid cannot cover institutional treatment in
programs with more than 16 beds
5. Increase pain care education in medical
curricula
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
“Omnibus” Draft Legislation (5/6)
6. Pain management awareness campaign
– Impact and magnitude: 100 million Americans in
pain (IOM)
– Risks, benefits, availability of treatment options
– Danger of diversion and sharing prescriptions
7. Abuse-deterrent technology
– FDA road map and incentives for manufacturers
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
“Omnibus” Draft Legislation (6/6)
8. Expand access to opioid addiction treatment
– Raise treatment limits from 30/100 to 250/500
9. Increase access to naloxone
10.Expand federal data collection on pain
prevalence, barriers to care
11.Expand evidence-based data collection efforts
around pain and pain management
12.Ensure coverage for quantitative urine drug
testing for federal health program beneficiaries
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Networking Lunch
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
State Policy Update
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Overdose Death
Prevention Act
Karen Perry
Executive Director
NOPE Task Force
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Richard Perry
Age 21
Florida Hospital Consent to Treatment
Hospital Release Orders
Facts

In 2012, there were 33,175 unintentional drug
overdose deaths in the United States.
(Source: Center for Disease Control)

2.5 million emergency department visits are
attributed to drug misuse or overdose.
(Source: Drug Abuse Warning Network (DAWN), 2011 National ED Estimates)

26.8% of the people who died from a drug
overdose had experienced a prior drug
overdose with a hospital visit. (Source: Palm Beach County
Sheriff’s Office Overdose Suppression Project 2013)

82.3 % of the decedents had a known
substance abuse history
(Source: Palm Beach County Sheriff’s Office Overdose Suppression Project 2013)

51.3 % of the decedents were under the care of
a physician
(Source: Palm Beach County Sheriff’s Office Overdose Suppression Project 2013)
Heart Attack Victim Care
The first 24 hours following a heart attack are usually spent in
a coronary care unit (CCU) or an intensive care unit(ICU).
Where skilled staff will:
 Continuously monitor your heart rhythm
 Administer a series of test and blood work
 Administer medication as needed
 Review patient’s history
 Contact primary care and/or cardiac care physicians
Cardiac Care Day Two
If you remain stable after 24 hours
You may be transferred to the
"telemetry" floor of the hospital
 Continue to receive care by a
cardiac care team.
 Depending upon the severity of
the heart attack and how quickly
you received treatment, you may
be able to go home within two to
four days.
Overdose Patient
Treat and Street
Intervention Point
Overdose Death Prevention Act (ODPA)
A bill that requires specific
rules that would apply to
an emergency care
practitioner when the
patient suffers a non-fatal
unintentional overdose.
ODPA Rules and Procedures
 Proper medical
stabilization (detox)
 Substance Abuse
Screening Brief
Intervention and Referral
to Treatment (SBIRT)
ODPA Rules and Procedures
 Notify patient’s
primary care physician.
 Notify all patient’s
prescribing doctors
within last 12 months.
ODPA Rules and Procedures
 Notify the patient’s
emergency contact or next
of kin.
 Provide materials on addiction
treatment, treatment facilities
and practitioners.
 Provide local involuntary
treatment laws.
HIPAA
The HIPAA law currently indicates that emergency room
physicians may notify next of kin if they feel it important
or necessary for survival of the patient.
This linked-document (authored by the U.S. Department of Health and
Human Services) provides a summary of the HIPAA Privacy
Rule. http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/in
dex.html
HIPAA
Federal Register-Volume 65. No. 250 (12-28-2000) Section 164.502(g) –
Personal Representatives
“We continue to allow covered entities to use their discretion to disclose
certain protected health care information to family members, relatives,
close friends, and other persons assisting in the care of an individual, in
accordance with 164.510(b). We recognize that many health care
decisions take place on an informal basis, and we permit disclosures in
certain circumstance to permit this practice to continue. Health care
providers may continue to use their discretion to address these informal
situations” (p. 82501).
Readmissions
Because Centers for Medicare & Medicaid Services
will penalize hospitals that see too many patients
return within a month, now is the time to create
strategies to avoid readmissions.
The Centers for Medicare & Medicaid Services have
been focusing on reducing acute care readmissions
within 30 days of discharge through its Hospital
Readmissions Reduction Program. Hospitals with
higher than expected 30-day readmission rates
incur penalties against their total Medicare
payments as federal fiscal year 2013.
Commercial payers likely will follow suit, as
organizations such as the Joint Commission,
Partnership for Patients and the National Quality
Forum support this program.
Education and Advocacy
 Be informed of local issues
 Build Relationships
 Educate Legislators and
community partners
 Create tool kit for
community partners
 Attend and provide
testimonials at important
legislative meetings
NOPE Task Force
Mission
To reduce the frequency
and impact of drug
overdose death through:
Community Education
Family Support
Purposeful Advocacy
Karen H. Perry
Executive Director
kperry@nopetaskforce.org
561-478-1055 x201
Controlled Substance Enforcement Update
With special thanks to:
Lucy C. Gee, M.S., Director
Florida Department of Health
Oxy
Florida Lethal Occurrences by Drugs
1516
2008
2009
2010
1185
941
648
529
119
95
Heroin
561
48
Cocaine
Oxycodone
All data provided by the Florida Department of Law Enforcement: Florida Medical Examiner’s Reports
HB 7095 (2011) Overview
• Increased penalties for violations of controlled
substance prescribing requirements
• Counterfeit-proof prescriptions pads
• Physicians and dentists to register on profile if
prescribe controlled substances for pain
• Standards for controlled substance prescribing
77
HB 7095 Overview (2011)
•
Pain management clinic registration
- Physical examination
- Designated physician
- Exemptions from registration
•
Prohibition on physician dispensing of CS
II and III
78
HB 7095 (2011) Overview
• Public Health Emergency declared July 1, 2011
- July 5 law enforcement and department
investigators quarantined 105,579 drugs
• Pharmacies required to re-register with criminal
background screening
79
HB 7095 (2011) Overview
• Days to report dispensing information to PDMP
decreased from 15 days to 7
• Changes to Chapter 499-Drug, Cosmetic and
Household Products
- Increased criminal acts
- Wholesalers required to report distribution of
controlled substances to database
- Wholesalers required to credential physicians and
pharmacies
80
Pain Management Clinics
Registered
921
823
441
384
FY2009-2010
Senate Bill 462
2009
FY2010-2011
Senate Bill 2272
2010
FY2011-2012
FY2012-2013
House Bill 7095
2011
372
FY2013-2014 To Date
81
Pain Management Clinic
Inspections
1000
900
800
700
600
500
400
300
200
100
0
906
716
375
248
3 3
FY2009 2010
256
136
FY2010 2011
FY/2011 2012
# of inspections completed
FY2012 2013
226188
FY2013 2014
(1/15/2014)
# passed on first inspection
82
Prescribers
Oxycodone Dosage Units Purchased by
Florida Practitioners
40,000,000
35,263,401
5 Months
35,000,000
30,000,000
25,000,000
20,000,000
15,000,000
10,000,000
925,274
5 Months
5,000,000
400,001
12 Months
275,028
10 Months
0
Jan 2010 - May 2010
Jan 2011 - May 2011
Source: ARCOS DEA Registration
Jan 2012-Dec 2012
Jan 2013 - Oct 2013
83
Nationwide Comparison of Oxycodone Purchases by Practitioners
January - June 2010
45,000,000
41,285,772
40,000,000
35,000,000
30,000,000
25,000,000
20,000,000
15,000,000
10,000,000
5,000,000
1,021,933
794,124
489,942
302,873
255,442
240,768
231,877
188,102
174,208
OH
GA
MD
CA
TN
KY
PA
NV
NC
1,102,120
-
FL
Remaining
States
Nationwide Comparison of Oxycodone Purchases by Practitioners
January - June 2010
45,000,000
41,285,772
40,000,000
35,000,000
Units Purchased
30,000,000
25,000,000
20,000,000
15,000,000
10,000,000
4,801,389
5,000,000
-
Florida
Remaining States
Prescribers
Oxycodone Prescriptions
Issued
# Oxycodone Prescriptions
2,000,000
1,800,000
1,600,000
1,400,000
1,200,000
1,000,000
800,000
600,000
400,000
200,000
0
FY2011-2012 (Oct-Sep)
FY2012-2013 (Oct-Sep)
# Oxycodone Prescriptions
Source: Prescription Drug Monitoring Program
86
Dispensers
Community Pharmacies
4,843
4,703
4,733
4,748
4,437
FY2009-2010
FY2010-2011
FY2011-2012
FY2012-2013
FY2013-2014
To Date
# OF Community Pharmacies
87
51% Decrease in Doctor
Shopping
3,000
2,864
2,500
2,174
2,017
1,861
2,000
1,726
1,680
1,613
1,415
1,500
1,000
500
105
68
45
43
46
36
38
31
0
Q1 2012
Q2 2012
Q3 2012
Q4 2012
5+ prescribers & 5+ pharmacies
Source: Prescription Drug Monitoring Program
Q1 2013
Q2 2013
Q3 2013
Q4 2013
10+ prescribers & 10+ pharmacies
88
Pain Management Clinic
“Oxycontin Express” Derailed
8,077
9,000
8,000
7,000
4,787
6,000
5,000
3,655*
4,000
1,735
3,000
2,000
1,000
0
FY2010 - 2011
FY/2011 - 2012
FY2012 - 2013
FY2013 - 2014
(1/15/2014)
Out of state
Figures are from Jan-June 2011 and required at that time only from Osteopatic Physicians
89
Discipline and
Emergency Actions
82
90
80
72
69
70
60
40
27
30
16
20
10
48
47
42
41
50
13
5
5
0
FY 2008-09
FY 2009-10
FY 2010-11
Emergency Actions
FY 2011-12
FY 2012-13
FY 2013-14
Through
12/5/2013
Disciplinary Actions
90
41% Decrease in Oxycodone
Deaths in Florida in 2012
1,600
1,516
1,400
1,200
1,185
1,000
1,247
941
800
705
600
400
299 340 340
496
735
200
0
2003 2004
2005 2006
2007 2008
2009 2010
2011 2012
Source: Drugs Identified in Deceased Persons by Florida Medical Examiners 2012 Report
*The interim report for the first six months of 2013 will be available in late Spring, early Summer 2014.
91
Legislative
Regulatory Tools
•
•
•
•
•
•
•
Pain management clinic registration
Prohibitions on dispensing
Practice standards for prescribing
Implementation of PDMP
Counterfeit-proof prescription pads
Re-permitting of pharmacies
No preemption of local regulation
Summary Results
• 60% decrease in pain management clinics
• 83% pain management clinics pass stricter
standards on the first inspection
• 24% reduction in Oxycodone prescriptions
written by Florida doctors since 2011-12
Summary Results
• Annual Oxycodone purchases reduced from
>35 million to <500,000
• 27% decrease in patients discharged for
drug abuse
• 70% decrease in patients discharged for
drug diversion
Summary Results
• 41% decrease in out-of-state patients
• 51% decrease in doctor shopping >5
Summary Results
41% decrease in Oxycodone
deaths in Florida.
Source: Drugs Identified in Deceased Persons by Florida Medical Examiners 2012 Report
Office of the State Attorney
Fifteenth Judicial Circuit
Dave Aronberg
stateattorney@sa15.org
561-355-7100
Drug Policy and
Federal Supremacy
Michael C. Barnes
Executive Director
Center for Lawful Access and Abuse Deterrence
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Protecting Core Values:
Federal Supremacy
•
•
•
•
Article VI, paragraph 2 of the Constitution
The federal government regulates interstate commerce
Uninformed enthusiasm led to state attempts to ban a single medication
What’s next?
– Ban women’s health medications?
– ‘Medical’ heroin ballot measures and legislation?
– Importation of non-FDA-approved drugs
•
Broader issue
– Interstate commerce (e.g., 2nd Amendment Preservation Act: MO, ID, KS, AK)
– Fundamental protections (e.g., privacy of health care decisions)
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Maine Importation Law
• Maine permits consumer importation of drugs
from foreign pharmacies (Canada, U.K.,
Australia, and New Zealand) under 32 MRSA
§ 13731
– Concern re: proliferation of model across states
– NY and MA health plans facilitating illegal drug
importation to lower costs
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
California Supply Chain Law
• California prohibits the distribution, purchase,
and sales of counterfeit and diverted
medications under SB 600
• Imposes criminal penalties, including fines
and imprisonment
• Becomes effective law on January 1, 2015
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Which Model Will Prevail?
• Consumers and policy makers must be aware of
risks and implications of the illegal importation of
foreign drugs
• Insurers must provide adequate coverage of
FDA-approved medications
• The pharmaceutical industry must acknowledge
the role drug costs play in the importation
debate
• The federal government must enforce federal
law
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Break
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Center for Lawful Access and Abuse Deterrence (CLAAD)
National Prescription Drug Abuse Prevention
Policy Meeting
December 2, 2014 – Washington, D.C.
PRESCRIPTION MONITORING PROGRAMS –
PATIENT AND PRESCRIBER PRIVACY
Sarah Kelsey,
Chief Executive Officer
National Alliance for Model State Drug Laws
(NAMSDL)
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
What Is a Prescription Monitoring Program?
• 49 states and DC have enacted PMP legislation
• 49 states are operational, meaning they are both collecting
data and disclosing data
• DC is in the process of adopting regulations; will be operational
12-18 months after adoption
• California has the oldest continuously operating PMP, but
the first PMP was started in New York in 1918
• Began in paper format, started converting to electronic format
in Oklahoma in 1990
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
What Is a Prescription Monitoring Program?
• Public health and safety tool
• Used to detect patients, prescribers, and dispensers
at risk of addiction or diversion
• Dispensing data on Schedule II – IV or V prescriptions is
collected in a central repository
• Reporting dispensing data is mandatory
• Access to the data held in the repository is limited by statute
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Access to Prescription Monitoring Programs
• Direct access to data is generally limited to prescribers
and dispensers
• In most cases, prescribers and dispensers can only access
information on current patients – some states allow
prescribers to access data on prospective patients
• 17 states require law enforcement to have either a search
warrant, subpoena, or court order to receive PMP data
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Access to Prescription Monitoring Programs
• Only 10 of 36 states responding to a NAMSDL survey
allow direct access by law enforcement
• Of those 10, half limit the number or type of law enforcement
personnel allowed direct access
• “Fishing expeditions” are not allowed and wrongfully
accessing or using data can result in disciplinary action,
civil or criminal penalties
• Nebraska and Vermont do not allow law enforcement to have
access to PMP information through the PMP system
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Access to Prescription Monitoring Programs
• Most states keep records identifying who has accessed the
system, when, and on which patient, prescriber, or dispenser
• Those records can be used to identify any wrongful access of
the system, whether by law enforcement, prescriber, or
dispenser
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Penalties
• Civil penalties for wrongfully disclosing, using, or obtaining
information from PMP database range from a fine of $50 to
a fine of up to $250,000
• Average is $5,000 – 10,000
• Criminal penalties for wrongfully disclosing, using, or obtaining
information from PMP database range from misdemeanor
charges carrying a sentence of 30 days to felony charges
carrying a sentence of up to 10 years
• Penalties also include sanctions against a prescriber or
dispenser who violates privacy protections by the provider’s
regulatory or licensing board
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
HIPAA – Health Insurance Portability and Accountability Act
• Addresses use and disclosure of protected health information by
covered entities
• “Protected health information” = individually identifiable health
information that is transmitted or maintained electronically or
in any other form or medium
• “Covered entities” = health care plan, health care clearing house,
or a health care provider who electronically transmits health
information to carry out financial or administrative activities
related to health care covered under HIPAA
• Ex., health care payments, coordination of benefits, health
care claims
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
HIPAA – Health Insurance Portability and Accountability Act
• PMPs are not considered to be covered entities under HIPAA
and are, therefore, not subject to the HIPAA privacy rule,
meaning they can disclose prescription information submitted
to the PMP without violating HIPAA
• Dispensers are considered to be covered entities, so they must
comply with HIPAA when disclosing prescription information
to PMPs
• Disclosure without permission of the patient may be made:
• To certain types of agencies/officials
• For 12 designated public interest purposes
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
HIPAA – Health Insurance Portability and Accountability Act
• Public interest purposes applicable to PMP activities:
• Disclosure required by law
• Legal mandate compels use or disclosure of
information and is enforceable in court
• Ex., statutes, regulations, subpoenas, court orders
• Public health activities
• Authority/agency must be responsible for public health
matters as part of official mandate
• Authority/agency must be authorized by law to collect
or receive information for … public health surveillance,
public health investigation, and public health intervention
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Electronic Health Records and PMPs
• Electronic health record (EHR) is a digital version of a
patient’s health record
• Health information exchange (HIE) allows medical providers
to access the medical records of patient across organizations
within a region, community, or hospital system
• Also refers to the company or organization that
facilitates the exchange of information
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Electronic Health Records and HIPAA
• The “Safeguards Principle in the Privacy and Security
Framework” – trust in electronic health information exchange
can only be achieved if reasonable administrative, technical,
and physical safeguards are in place
• HIPAA supports the Safeguards Principle by requiring covered
entities to implement appropriate administrative, technical, and
physical safeguards
• Safeguards include: securing locations and equipment;
implementing technical solutions; workforce training
• Standard is flexible to allow entities of different sizes, functions,
and needs to protect the privacy of protected health information
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Electronic Health Records and PMPs
• CRISP – Chesapeake Regional Information System for Our
Patients
• Patients may opt out of system, meaning that a patient’s
record will not be returned as the result of a query by a
provider
• Certain sensitive health information is not included in the
record, including mental health information that may be
restricted from disclosure by local, state, or federal law
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Electronic Health Records and PMPs
• CRISP provides access to the Maryland PMP
• Access is limited to clinical providers – prescribers,
dispensers, and other licensed healthcare practitioners
• Law enforcement, licensing boards, and all other types of
users authorized by MD law must go through the MD PMP
portal
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Electronic Health Records and PMPs
• CRISP security protections include:
•
•
•
•
Encryption
Password protection
Ability to track every viewer of data and audit the system
Other safeguards to protect against unauthorized use of
the information
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Caselaw
• Oregon Prescription Drug Monitoring Program vs. DEA
• Initiated by the Oregon PDMP in September 2012
• Asking for a declaratory judgment requiring the DEA
to have a warrant to access PDMP data
• Federal law only requires DEA to have an administrative
subpoena
• ACLU, four individuals who receive prescriptions for
controlled substances in Oregon, and an Oregon physician
were granted leave to intervene
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Caselaw
• District Court granted the motion of the intervening Plaintiffs
for summary judgment declaring that compliance with the
administrative subpoenas issued by the DEA would violate
the Fourth Amendment rights of the intervening Plaintiffs and
enjoined the DEA from issuing further subpoenas for records
• DEA appealed, and the case is currently pending in the 9th
Circuit Court of Appeals
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Missouri – The Lone Holdout
• The Missouri legislature has been attempting to pass a PMP
bill for at least the last three years and it has been stalled in
the Senate every time
• The main obstacles to getting legislation passed have been
the concerns of certain Senators regarding the privacy and
security of prescription information
• Because MO is the only state without a PMP, pharmacists
are seeing patients from all over the country come to MO to
fill prescriptions
• New legislation is being prepared; expected to be prefiled
Dec. 1 in the MO legislature
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
CONTACT INFORMATION
Website: www.namsdl.org
SARAH KELSEY, CEO
NAMSDL Headquarters
420 Park Street
Charlottesville, VA 22902
Phone: 703-836-6100, ext. 119
Email: skelsey@namsdl.org
HEATHER GRAY, Legislative Attorney
Phone: 703-836-6100, ext. 114
Email: hgray@namsdl.org
National Alliance for Model State Drug Laws, 420 Park Street, Charlottesville, Virginia 22902, 703-836-6100.
Mitigating Unintended
Consequences Part 2
Michael C. Barnes, Esq.
Executive Director
Center for Lawful Access and Abuse Deterrence
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Protecting Core Values: Privacy (1/4)
• Utah PMP: active investigation standard
1. Detective accessed PMP data (“ongoing
investigation”) to steal pain medications from a
couple
2. On a “hunch,” detective searched PMP records
of 480 first responders (after morphine theft from
ambulances). Defendant’s records exhibited “the
appearance of opioid dependence.” Charged
with Rx fraud (unrelated to morphine theft)
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Protecting Core Values: Privacy (2/4)
• TN: Detective fired for investigating director
of regional drug task force on his own (active
investigation)
• Outlier cases
• Severe penalties for data breach
• Training and oversight are necessary
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Protecting Core Values: Privacy (3/4)
• Oregon: U.S. District Judge ruling
– Patients and physicians both have a reasonable
expectation of privacy
– Two types of privacy interests implicated by
prescription records
• “Avoiding disclosure of personal matters”
• “Independence in making certain kinds of important
decisions”
– Probable cause (vs. administrative subpoena) is
necessary under Fourth Amendment
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Protecting Core Values: Privacy (4/4)
• When PMPs are optimized, is there a need to access
patient-specific data for investigative purposes?
– Prescribers are obligated to check PMP data
– Red flags alert PMP staff to abnormal patterns (patient or
prescriber)
– Persons with substance-related disorders are referred to
treatment
– Negligent prescribers who enable consumer misuse, abuse, or
diversion are referred to the medical board
– Intentional bad actors are referred to law enforcement
• Shouldn’t referrals from PMP staff to the medical board and
then (if necessary) to law enforcement be adequate?
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Preview of 2015 Activities
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Upcoming CLAAD Activities
•
•
National Prescription Drug Abuse Prevention Strategy
Articles
– Notre Dame Journal of Law, Ethics, & Public Policy
– Therapeutic Advances in Drug Safety
– Journal of Opioid Management
•
Presentations
– Home Care Association of Florida
– Addiction Executives Industry (aXis) Summit
– Notre Dame Journal of Law, Ethics, & Public Policy Symposium
– National Rx Drug Abuse Summit
– National Association of Addiction Treatment Providers
– American Society for Pain Management Nursing
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.
Thank You
COMMERCIAL SUPPORTERS
W W W. C L A A D . O R G
@CLAAD_COALITION • #RXABUSE
WASHINGTON, D.C.