Delivery of Integrated Delivery of Integrated Clinical Care for Patients Clinical Care for Patients

with Addictions and Federal with Addictions and Federal Confidentiality LawsConfidentiality Laws

Richard Saitz MD, MPHRichard Saitz MD, MPHCatherine O’Neill, JDCatherine O’Neill, JDEric Goplerud, PhDEric Goplerud, PhD

Sharon Levy MD, MPHSharon Levy MD, MPH

AgendaAgenda

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?

AgendaAgenda

ScopeScope General health settingsGeneral health settings Integration of careIntegration of care Screening and brief intervention Screening and brief intervention

Intro: 10”Intro: 10” Each panelist: 15”Each panelist: 15” Facilitated audience/panel Facilitated audience/panel

discussion: 35”discussion: 35”

ResourcesResources CFR 42 Part 2CFR 42 Part 2 Legal Action Center. Frequently asked questions Legal Action Center. Frequently asked questions

(FAQs): Applying the substance abuse confidentiality (FAQs): Applying the substance abuse confidentiality regulations to health information exchange. 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 Beckerman JZ et al. A delicate balance: behavioral

health, patient privacy, and the need to know.health, patient privacy, and the need to know. HIPAA Administrative Simplification. HIPAA Administrative Simplification. Letters to (and from) SAMHSA AdministratorLetters to (and from) SAMHSA Administrator

from ASAM, AAAP, AMERSA, AOAA, Patient Protection from ASAM, AAAP, AMERSA, AOAA, Patient Protection Coalition, National Alliance for Medication Assisted Coalition, National Alliance for Medication Assisted Recovery, others… Recovery, others…

What is high quality integrated What is high quality integrated care?care?

Systems with information availableSystems with information available Patient-Centered Medical HomesPatient-Centered Medical Homes Integrated delivery of medical and Integrated delivery of medical and

addiction careaddiction care Ongoing care beyond an acute episodeOngoing care beyond an acute episode Buprenorphine in primary careBuprenorphine in primary care Medical services at an addictions Medical services at an addictions

programprogram Screening and brief interventionScreening and brief intervention

CFR 42 Part 2CFR 42 Part 2

Written in 1972Written in 1972 No integrated careNo integrated care

Rationale: special privacy protection Rationale: special privacy protection because of stigmabecause of stigma to encourage help seekingto encourage help seeking to decrease discrimination.to decrease discrimination.

Stigma and discrimination, 2010Stigma and discrimination, 2010

Still here.Still here. Concerns re: poor treatment are real Concerns re: poor treatment are real

when clinicians not well-trained in when clinicians not well-trained in substance use conditionssubstance use conditions Pain managementPain management StereotypingStereotyping

Most generalist clinicians not well-Most generalist clinicians not well-trainedtrained

Addictions 2010Addictions 2010 Patients and families seek same high quality of Patients and families seek same high quality of

care for this condition as for otherscare for this condition as for others IOM 2005: Improving the quality of health care for IOM 2005: Improving the quality of health care for

mental and substance use conditionsmental and substance use conditions They want their condition to be recognized as a They want their condition to be recognized as a

health conditionhealth condition But, addiction generally treated separately, and But, addiction generally treated separately, and

not like a health condition (even other not like a health condition (even other stigmatized ones)stigmatized ones) Examples:Examples:

Treatment is separateTreatment is separate Records are separateRecords are separate Societal/general public (and therefore health professional) Societal/general public (and therefore health professional)

viewsviews

What do the regulations say?What do the regulations say?

ApplicabilityApplicability1)Federal assistance1)Federal assistance2)Hold yourself out…(next slide)2)Hold yourself out…(next slide) Federally assistedFederally assisted, e.g., e.g.

MedicareMedicare VAVA Controlled Substances Act registration to prescribe Controlled Substances Act registration to prescribe

controlled substances to treat addictioncontrolled substances to treat addiction e.g. benzodiazepines for withdrawale.g. benzodiazepines for withdrawal e.g. buprenorphine for dependencee.g. buprenorphine for dependence NOT naltrexone for dependenceNOT naltrexone for dependence

You have IRS tax exempt statusYou have IRS tax exempt status

What do the regulations say?What do the regulations say?

ApplicabilityApplicability1) Program that 1) Program that HOLDS ITSELF OUTHOLDS ITSELF OUT AS A AS A

2) OR identified unit within a general 2) OR identified unit within a general medical facility that medical facility that HOLDS ITSELF HOLDS ITSELF OUTOUT AS A AS A

3) OR staff whose 3) OR staff whose primary functionprimary function is AS is AS A…A…

PROVIDER AND PROVIDE(S) ALCOHOL PROVIDER AND PROVIDE(S) ALCOHOL OR DRUG DIAGNOSIS, TREATMENT OR DRUG DIAGNOSIS, TREATMENT

OR REFERRAL FOR TREATMENTOR REFERRAL FOR TREATMENT

What do the regulations say?What do the regulations say?

Release (and re-disclosure) to health Release (and re-disclosure) to health providers requires specific patient written providers requires specific patient written authorizationauthorization Exceptions:Exceptions:

Within the VAWithin the VA Within the Armed ForcesWithin the Armed Forces Medical emergency: Medical emergency: an immediate threat and need for an immediate threat and need for

immediate treatmentimmediate treatment General medical facility, unless…General medical facility, unless…

““holds itself out” or “primary function” then this can holds itself out” or “primary function” then this can include hospital, ER, doctor’s office, health center…include hospital, ER, doctor’s office, health center…

No discrimination prohibitions or protectionsNo discrimination prohibitions or protections small fines for release $500, up to $5000small fines for release $500, up to $5000

Do the regulations impede quality Do the regulations impede quality care?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 Patients may not know how restriction of information can impact diagnosis and information can impact diagnosis and treatment of other treatment of other conditions>>uninformed choiceconditions>>uninformed choice

Misdiagnosis (abdominal pain and sweats; medication Misdiagnosis (abdominal pain and sweats; medication side effect)side effect)

Duplicate or inappropriate treatmentsDuplicate or inappropriate treatments Medication interactions (e.g. methadone)Medication interactions (e.g. methadone)

Simple solutions?Simple solutions?

Sign a (“global”) releaseSign a (“global”) release NamedNamed provider, provider, specificspecific purpose, expiration purpose, expiration

date/eventdate/event Cannot use for disease management purposes Cannot use for disease management purposes

without specific consentwithout specific consent ““Qualified Service Organization” (QSO) Qualified Service Organization” (QSO)

exceptionexception Supposed to be for organizations that provide Supposed to be for organizations that provide

services to addiction programs that are services to addiction programs that are incidental to drug treatment (e.g. billing)incidental to drug treatment (e.g. billing)

Not to provide integrated health careNot to provide integrated health care

Other conditionsOther conditions

With other conditions, after listening With other conditions, after listening to patients we rely on record review to patients we rely on record review for for detaildetail not easy for patients to providenot easy for patients to provide

ScenariosScenarios

A A federally assistedfederally assisted SBIRT program SBIRT program has a health educator whose has a health educator whose primary primary functionfunction is to provide diagnosis and is to provide diagnosis and treatment or referraltreatment or referral

A primary care physician asks all of A primary care physician asks all of her patients about unhealthy alcohol her patients about unhealthy alcohol useuse

ScenarioScenario

Patient comes to ED after minor auto Patient comes to ED after minor auto accident for evaluation. Hospitalized for accident for evaluation. Hospitalized for observation.observation. Health promotion advocateHealth promotion advocate identifies alcohol identifies alcohol

dependence.dependence. Patient transferred to inpatient service, Patient transferred to inpatient service,

different cliniciansdifferent clinicians. Patient develops severe . Patient develops severe alcohol withdrawal.alcohol withdrawal.

Seen in the ED doesn’t mean medical Seen in the ED doesn’t mean medical emergency, and therefore not an exception emergency, and therefore not an exception (unless screening done by someone for (unless screening done by someone for whom it is not primary function)whom it is not primary function)

ScenarioScenario

BuprenorphineBuprenorphine Medication and counseling in a PC practiceMedication and counseling in a PC practice

Sounds like a program…SAMHSA has said soSounds like a program…SAMHSA has said so If covered by CFR 42, and patient receives addiction If covered by CFR 42, and patient receives addiction

and medical treatment from the same physician…and medical treatment from the same physician…what happens to the other medical information?what happens to the other medical information?

Is it the physician’s primary function?Is it the physician’s primary function? 30 patients30 patients 100 patients (PCP panel sizes 500-2000)100 patients (PCP panel sizes 500-2000)

How about a nurse care manager—primary How about a nurse care manager—primary function?function?

ResourcesResources CFR 42 Part 2CFR 42 Part 2

see ecfr.gpoaccess.govsee ecfr.gpoaccess.gov Frequently asked questions (FAQs): Applying the substance Frequently asked questions (FAQs): Applying the substance

abuse confidentiality regulations to health information abuse confidentiality regulations to health information exchange.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. 11-13Behav Healthcare, April 2010, pp. 11-13 And www.popovitslaw.com/42CFRupdatesAnd www.popovitslaw.com/42CFRupdates

Beckerman JZ et al. A delicate balance: behavioral health, Beckerman JZ et al. A delicate balance: behavioral health, patient privacy, and the need to know.patient privacy, and the need to know. Issue Brief. California Healthcare Foundation, March 2008.Issue Brief. California Healthcare Foundation, March 2008.

HIPAA Administrative SimplificationHIPAA Administrative Simplification 45 CFR 160, 162, 16445 CFR 160, 162, 164

Letters to (and from) SAMHSA AdministratorLetters to (and from) SAMHSA Administrator from ASAM, AAAP, AMERSA, AOAA, Patient Protection coalition, from ASAM, AAAP, AMERSA, AOAA, Patient Protection coalition,

National Alliance for Medication Assisted Recovery, others… National Alliance for Medication Assisted Recovery, others…