Transcript Slide 1

Center for Integrated Behavioral Health Policy
Department of Health Policy, The George Washington University Medical Center
Protecting Privacy, Protecting Health in
an Era of EHRs and HIEs:
The Challenges of Federal Substance
Use Privacy Regulations
Eric Goplerud, Ph.D.
AMERSA
November 5, 2010
Need for Substance Use Treatment
• 23.1 million adults and adolescents needed treatment
for an illicit drug or alcohol use problem
– (9.2 percent of US adults and teens).
• 4.0 million adults and teens received treatment for
alcohol or illicit drugs
– (1.6 percent of the population)
• Of these, 2.3 million received treatment in a specialty
SUD program
– (0.9 percent)
• Or 10% of those needing treatment, got it from a
specialty SUD program.
•
Source: Substance Abuse and Mental Health Services Administration. (2009). Results from the 2008 National
Survey on Drug Use and Health: National Findings (Office of Applied Studies, NSDUH Series H-36, HHS
Publication No. SMA 09-4434). Rockville, MD.
Insufficient specialty treatment capacity to treat
those who need substance use treatment
Number of Patients Per Facility Type
Self-Help Group
2,187
Outpatient Rehabilitation
1,455
Outpatient Mental Health Center
1,054
Inpatient Rehabilitation
743
Hospital Inpatient
675
Private Doctor's Office
672
Emergency Room
374
Prison or Jail
343
0
Source: 2008 NSDUH
500
1,000
1,500
2,000
Numbers in Thousands
2,500
Unmet BH Needs in Primary Care
• 67% with a behavioral health disorder do not get behavioral
health treatment1
• 30-50% of referrals from primary care to an outpatient
behavioral health clinic don’t make first appt2,3
• Two-thirds of primary care physicians (N=6,660) reported not
being able to access outpatient behavioral health for their
patients. Shortages of mental health care providers, health
plan barriers, and lack of coverage or inadequate coverage
were all cited by PCPs as important barriers to mental health
care access4
1. Kessler et al., NEJM. 2005;352:515-23.
2. Fisher & Ransom, Arch Intern Med. 1997;6:324-333.
3. Hoge et al., JAMA. 2006;95:1023-1032.
4. Cunningham, Health Affairs. 2009; 3:w490-w501.
4
More than One-Third SUD Treatment
Admissions from Criminal Justice
(680,000 of 1.8 million admissions)
Co-morbidity is to be expected:
Washington State GA-U Project
(General Assistance Unemployable)
DSHS | GA-U Clients: Challenges and Opportunities August 2006
Co-occurring MH and SUD:
Number and Source of Treatment
SA & MH
How Many? About 4 million
Treated Where?
Challenge unique to SUD:
The intersection of health care quality and
patient safety with protection of sensitive
SUD diagnosis and treatment information
• HIPAA, 42 CFR Part 2
• Risks of potential misuse,
and inappropriate disclosure
– Job loss,
– criminal prosecution,
– health and life insurance
coverage barriers
Physical Illness
Mental Health
&
Substance Use
Disorders
Depends on location of treatment,
not what kind of treatment
Patient treated in a
primary health clinic,
mental health clinic, PCP
office, FQHC
HIPAA Only
Physical Illness
Mental Health
&
Substance Use
Disorders
Patient treated in a
substance use treatment
program
42 CFR Part 2
and HIPAA
Physical Illness
Mental Health
&
Substance Use
Disorders
HIPAA: The Very Brief Version
• Establishes a federal “floor” of privacy protections while
preserving “more stringent” state laws
• Privacy rule applies to “covered health care entities”
• Individually identifiable health information “protected
health information”
• Permitted use: treatment, payment and health care
operations without written permission.
• Does not distinguish between types of PHI data other
than psychotherapy notes
HIPAA regulatory framework
– HHS Office of Civil Rights has power to ensure
compliance, investigate violations, impose civil
monetary penalties
– Since 2003, total of 28,000 complaints, 7,000
investigated, 4,700 achieved corrected actions, NO
FINES ASSESSED TO DATE
– No federal right of action for private individuals to sue
covered entities to halt disclosure or recover damage
42 C.F.R. Part 2 – Confidentiality of Alcohol
and Drug Abuse Patient Records
• Meant to encourage people to seek out and remain in SA treatment
without fear of prosecution by law enforcement and the government
• Promulgated 1975, updated 1980, 1983, 1987
• Creates a virtual shield against disclosure of PHI related to SArelated conditions and treatment, especially shield against law
enforcement and court ordered disclosures
• Strictly prohibits disclosure and use of SA records of any federally
assisted alcohol and drug use program (federally assisted very
broadly defined)
42 CFR Part 2: Definitions
• Disclosure:
– “a communication of patient identifying information,
the affirmative verification of another person’s
communication of patient identifying information, or
the communication of any information from the record
of a patient who has been identified.”
• Patient Identifying Information:
– includes name, address, social security, finger prints,
photographs, or “similar information by which the
identity of a patient can be determined with
reasonable accuracy or speed either directly or by
reference to other publicly available information.”
• Criminal penalties and fines for violations
42 CFR Part 2
Exceptions to
Authorization
HIPAA Exceptions
To Authorization
Internal Communications
Treatment, Payment, Health
Care Operations
No Patient identifying
information
All other HIPAA exceptions
Medical emergency
Treatment
Court order
Court Order
Crime on premises
Law Enforcement
Child Abuse and neglect
reporting
Required by law
Research/audit, evaluation
Health Care Operations, Health
Oversight, and Research
Qualified Service Organization
(QSO)
Health Care Operations with
Business Associate Agreement
Issues with current
interpretation of 42 CFR Part 2
• FACT # 1: Addiction treatment
information is not itself protected under
the confidentiality law only records
held by federally assisted “programs”.
Thus, the content of information is not
protected if it is not in a “program”.
• FACT # 2: Discrimination concerns are
the primary impetus behind the
confidentiality statute, yet the statute is
silent on any provisions relating to
discrimination.
… ignorance of and hostility towards the disease of drug dependence, those who suffer
from it, and the treatments provided are at least as prevalent among healthcare
providers as among the general population. Based on long and distressingly consistent
experience, I am convinced that patients have much more to fear from ill-informed and
biased physicians, nurses, social workers, etc. than they might possibly hope to gain
from enhanced coordination through record sharing.
For example, patients who acknowledge upon hospitalization or referral to a new caregiver that they receive methadone maintenance are often told, “We don't believe in
substituting one drug for another," and find their usual methadone dosage reduced or
discontinued altogether. Post-operative patients are often labeled "drug-seeking"
manipulators when they complain of pain, and doctors commonly refuse to order –
and/or nurses to administer – adequate analgesic medication.
FACT # 3: Stigma and discrimination
exist today notwithstanding the federal
confidentiality laws and regulations.
• FACT # 4: Qualified service
organization (“QSO”) agreements
permit information sharing with
medical providers that “provide
services to a program”. May not be
practically useful for .
FACT # 5: The remedies under the
confidentiality statute for violation are
limited to a $500 criminal penalty and can
be increased to $5,000 for additional
violations.
FACT # 6: Unlike other diseases, the
very real fears about law enforcement
accessing the information emphasize the
need to maintain, even strengthen the
confidentiality protections in the statute
and regulations.
FACT # 7: Addiction is a disease and
should be treated as such.
Important Clinical Issues:
Screening in Primary Care
• From SAMHSA*
– Information gathered by a program for purposes other
than a diagnosis, treatment, or referral for treatment is
not subject to the 42 C.F.R. Part 2 restrictions
covered
– Screen or pre-screen procedures: Identifying an
Individual as possibly having a substance abuse
problem by use of a screening or prescreening
procedure that is not conducted as part of diagnosis
or treatment is not subject to the 42 CFR Part 2
restrictions
*SAMSHA Technical Assistance Publication Series 24, “Welfare Reform and Abuse
Treatment Confidentiality: General Guidance for Reconciling Need to Know and
Privacy”
Primary Function is not SUD Treatment
• Guidance from SAMHSA
– If a program can disclose a patient’s identifying
information without indicating “patient” status, 42 CFR
Part 2 is not violated
• Disclosures possible primarily when a program is part of a
larger entity(FQHC, primary care practice, hospital
emergency department, general hospital, community mental
health center) and can use the larger entity’s name when
making the disclosure
• Physician prescribing SUD medications within a general
medical practice or psychiatric practice
• Anonymous disclosures (e.g. vulnerable adult abuse
reporting, duty to warn)
Technical Assistance Publication Series 18, “Checklist
for Monitoring Alcohol and Other Drug Confidentiality
Compliance”
Qualified Service Organization
Arrangements (QSOAs)
– Person or program that provides services to a SUD
program that has entered into a written agreement
acknowledging it is bound by 42 CFR Part 2 and will
resist judicial disclosure (other than as permitted)
– Examples (operational services to organization, not
program to program for substance abuse treatment)
•
•
•
•
•
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Data processing
Bill collecting
Dosage preparation
Laboratory Analysis
Professional services (legal, medical, accounting)
Services to prevent, treat child abuse, including training on
nutrition and child care or individual and group counseling