1. Delivery of Integrated Clinical Care for Patients with Addictions and Federal Confidentiality Laws Richard Saitz MD, MPH Catherine O’Neill, JD Eric Goplerud, PhD Sharon Levy MD, MPH

2. Agenda What are the rules? What are the rules? Where and when do they apply? Where and when do they apply? What are the implications? What are the implications?

3. Agenda Scope Scope General health settings General health settings Integration of care Integration of care Screening and brief intervention Screening and brief intervention Intro: 10” Intro: 10” Each panelist: 15” Each panelist: 15” Facilitated audience/panel discussion: 35” Facilitated audience/panel discussion: 35”

4. Resources CFR 42 Part 2 CFR 42 Part 2 Legal Action Center. Frequently asked questions (FAQs): Applying the substance abuse confidentiality regulations to health information exchange. Legal Action Center. Frequently asked questions (FAQs): Applying the substance abuse confidentiality regulations to health information exchange. Popovits RM. Confidentiality law: time for a change? Popovits RM. Confidentiality law: time for a change? Beckerman JZ et al. A delicate balance: behavioral health, patient privacy, and the need to know. Beckerman JZ et al. A delicate balance: behavioral health, patient privacy, and the need to know. HIPAA Administrative Simplification. HIPAA Administrative Simplification. Letters to (and from) SAMHSA Administrator Letters to (and from) SAMHSA Administrator from ASAM, AAAP, AMERSA, AOAA, Patient Protection Coalition, National Alliance for Medication Assisted Recovery, others… from ASAM, AAAP, AMERSA, AOAA, Patient Protection Coalition, National Alliance for Medication Assisted Recovery, others…

5. What is high quality integrated care? Systems with information available Systems with information available Patient-Centered Medical Homes Patient-Centered Medical Homes Integrated delivery of medical and addiction care Integrated delivery of medical and addiction care Ongoing care beyond an acute episode Ongoing care beyond an acute episode Buprenorphine in primary care Buprenorphine in primary care Medical services at an addictions program Medical services at an addictions program Screening and brief intervention Screening and brief intervention

6. CFR 42 Part 2 Written in 1972 Written in 1972 No integrated care No integrated care Rationale: special privacy protection because of stigma Rationale: special privacy protection because of stigma to encourage help seeking to encourage help seeking to decrease discrimination. to decrease discrimination.

7. Stigma and discrimination, 2010 Still here. Still here. Concerns re: poor treatment are real when clinicians not well-trained in substance use conditions Concerns re: poor treatment are real when clinicians not well-trained in substance use conditions Pain management Pain management Stereotyping Stereotyping Most generalist clinicians not well-trained Most generalist clinicians not well-trained

8. Addictions 2010 Patients and families seek same high quality of care for this condition as for others Patients and families seek same high quality of care for this condition as for others IOM 2005: Improving the quality of health care for mental and substance use conditions IOM 2005: Improving the quality of health care for mental and substance use conditions They want their condition to be recognized as a health condition They want their condition to be recognized as a health condition But, addiction generally treated separately, and not like a health condition (even other stigmatized ones) But, addiction generally treated separately, and not like a health condition (even other stigmatized ones) Examples: Examples: Treatment is separate Treatment is separate Records are separate Records are separate Societal/general public (and therefore health professional) views Societal/general public (and therefore health professional) views

9. What do the regulations say? Applicability Applicability 1)Federal assistance 2)Hold yourself out…(next slide) Federally assisted, e.g. Federally assisted, e.g. Medicare Medicare VA VA Controlled Substances Act registration to prescribe controlled substances to treat addiction Controlled Substances Act registration to prescribe controlled substances to treat addiction e.g. benzodiazepines for withdrawal e.g. benzodiazepines for withdrawal e.g. buprenorphine for dependence e.g. buprenorphine for dependence NOT naltrexone for dependence NOT naltrexone for dependence You have IRS tax exempt status You have IRS tax exempt status

10. What do the regulations say? Applicability Applicability 1) Program that HOLDS ITSELF OUT AS A 2) OR identified unit within a general medical facility that HOLDS ITSELF OUT AS A 3) OR staff whose primary function is AS A… PROVIDER AND PROVIDE(S) ALCOHOL OR DRUG DIAGNOSIS, TREATMENT OR REFERRAL FOR TREATMENT

11. What do the regulations say? Release (and re-disclosure) to health providers requires specific patient written authorization Release (and re-disclosure) to health providers requires specific patient written authorization Exceptions: Exceptions: Within the VA Within the VA Within the Armed Forces Within the Armed Forces Medical emergency: an immediate threat and need for immediate treatment Medical emergency: an immediate threat and need for immediate treatment General medical facility, unless… General medical facility, unless… “holds itself out” or “primary function” then this can include hospital, ER, doctor’s office, health center… “holds itself out” or “primary function” then this can include hospital, ER, doctor’s office, health center… No discrimination prohibitions or protections No discrimination prohibitions or protections small fines for release $500, up to $5000 small fines for release $500, up to $5000

12. Do the regulations impede quality care? What is the effect of separate treatment on fear and discrimination, and on equally high quality care as other conditions? Patients may not know how restriction of information can impact diagnosis and treatment of other conditions>>uninformed choice Patients may not know how restriction of information can impact diagnosis and treatment of other conditions>>uninformed choice Misdiagnosis (abdominal pain and sweats; medication side effect) Misdiagnosis (abdominal pain and sweats; medication side effect) Duplicate or inappropriate treatments Duplicate or inappropriate treatments Medication interactions (e.g. methadone) Medication interactions (e.g. methadone)

13. Simple solutions? Sign a (“global”) release Sign a (“global”) release Named provider, specific purpose, expiration date/event Named provider, specific purpose, expiration date/event Cannot use for disease management purposes without specific consent Cannot use for disease management purposes without specific consent “Qualified Service Organization” (QSO) exception “Qualified Service Organization” (QSO) exception Supposed to be for organizations that provide services to addiction programs that are incidental to drug treatment (e.g. billing) Supposed to be for organizations that provide services to addiction programs that are incidental to drug treatment (e.g. billing) Not to provide integrated health care Not to provide integrated health care

14. Other conditions With other conditions, after listening to patients we rely on record review for detail With other conditions, after listening to patients we rely on record review for detail not easy for patients to provide not easy for patients to provide

15. Scenarios A federally assisted SBIRT program has a health educator whose primary function is to provide diagnosis and treatment or referral A federally assisted SBIRT program has a health educator whose primary function is to provide diagnosis and treatment or referral A primary care physician asks all of her patients about unhealthy alcohol use A primary care physician asks all of her patients about unhealthy alcohol use

16. Scenario Patient comes to ED after minor auto accident for evaluation. Hospitalized for observation. Patient comes to ED after minor auto accident for evaluation. Hospitalized for observation. Health promotion advocate identifies alcohol dependence. Health promotion advocate identifies alcohol dependence. Patient transferred to inpatient service, different clinicians. Patient develops severe alcohol withdrawal. Patient transferred to inpatient service, different clinicians. Patient develops severe alcohol withdrawal. Seen in the ED doesn’t mean medical emergency, and therefore not an exception (unless screening done by someone for whom it is not primary function) Seen in the ED doesn’t mean medical emergency, and therefore not an exception (unless screening done by someone for whom it is not primary function)

17. Scenario Buprenorphine Buprenorphine Medication and counseling in a PC practice Medication and counseling in a PC practice Sounds like a program…SAMHSA has said so Sounds like a program…SAMHSA has said so If covered by CFR 42, and patient receives addiction and medical treatment from the same physician…what happens to the other medical information? If covered by CFR 42, and patient receives addiction and medical treatment from the same physician…what happens to the other medical information? Is it the physician’s primary function? Is it the physician’s primary function? 30 patients 30 patients 100 patients (PCP panel sizes 500-2000) 100 patients (PCP panel sizes 500-2000) How about a nurse care manager—primary function? How about a nurse care manager—primary function?

18. Resources CFR 42 Part 2 CFR 42 Part 2 see ecfr.gpoaccess.gov see ecfr.gpoaccess.gov Frequently asked questions (FAQs): Applying the substance abuse confidentiality regulations to health information exchange. Frequently asked questions (FAQs): Applying the substance abuse confidentiality regulations to health information exchange. Legal Action Center, for SAMHSA Legal Action Center, for SAMHSA Popovits RM. Confidentiality law: time for a change? Popovits RM. Confidentiality law: time for a change? Behav Healthcare, April 2010, pp. 11-13 Behav Healthcare, April 2010, pp. 11-13 And www.popovitslaw.com/42CFRupdates And www.popovitslaw.com/42CFRupdates Beckerman JZ et al. A delicate balance: behavioral health, patient privacy, and the need to know. Beckerman JZ et al. A delicate balance: behavioral health, patient privacy, and the need to know. Issue Brief. California Healthcare Foundation, March 2008. Issue Brief. California Healthcare Foundation, March 2008. HIPAA Administrative Simplification HIPAA Administrative Simplification 45 CFR 160, 162, 164 45 CFR 160, 162, 164 Letters to (and from) SAMHSA Administrator Letters to (and from) SAMHSA Administrator from ASAM, AAAP, AMERSA, AOAA, Patient Protection coalition, National Alliance for Medication Assisted Recovery, others… from ASAM, AAAP, AMERSA, AOAA, Patient Protection coalition, National Alliance for Medication Assisted Recovery, others…