Hello, welcome to this talk on Ethics and the Law in Addiction Medicine. My name is Julie Knick and I'm going to be your speaker for today. Here's a little bit of information about me. I graduated from Western UConn and I completed my general psychiatry residency as well as addiction psychiatry fellowship at the University of Pittsburgh Medical Center. I'm currently an associate professor of psychiatry at the University of Pittsburgh. I have no conflicts of interest to disclose. These are the objectives for this talk. We're going to be talking about core ethical principles in medicine and how they relate to treating people with substance use disorders. I want to describe some special population and relevant ethical issues in their treatments and list federal laws and regulations relating to individuals with substance use disorder and their treatment. So first thing we're going to focus on is ethics and substance use disorders. So what are ethics? Well, ethics are a set of moral principles that govern a person's behavior. So essentially this is what we're doing when no one's watching. And there are professional societies and organizations that have developed codes of conduct that are based on ethics. Ethics can be encoded as practice standards within medicine. And there's a difference between what's legal versus what's ethical. So laws are codified and published, whereas ethics can vary by situation and individual. And what's legal may not be ethical. So the first thing we're going to talk about are core ethical principles. So these are autonomy, beneficence, non-malfeasance, justice, and fidelity. So first off is autonomy. Individuals have the power to make rational decisions and moral choices, and they should be allowed to exercise self-determination. So autonomy doesn't extend to people who lack capacity to make decisions and act autonomously. The capacity is assessed by healthcare professionals, whereas competence is determined by the court. Now part of autonomy is informed consent. And in informed consent, you need to disclose medical information and treatment options to the individual so they can exercise that self-determination. So part of this involves truth-telling and confidentiality. You have to tell people the accurate information so they can make an informed choice, and you also have to make sure that your conversations are confidential, because sometimes people might make a different choice if they thought that other people would find out. Let's talk a little bit more about informed consent. So this is an individual's right to accept medical treatment or interventions after being fully informed about the risks, benefits, and alternatives. So to provide informed consent, an individual must be able to understand and decide, so basically have decision-making capacity. And what that means is that they have to be able to state a preference or a choice. They have to understand relevant information. They need to understand their situation and its consequences, and they need to be able to reason through a consequential life decision. That means manipulating information rationally. So this was something that I often did when I was in psychiatry residency on consults. I would have to evaluate somebody for their decision-making capacity, so I needed to make sure that they were able to state what they wanted, but also that they understood relevant information about their condition, as well as about the treatment that was proposed, and then to understand about their situation and what the consequences are of treatment and also of not treating. And they had to be able to reason through that, and we'd have to be able to make sure that they could actually manipulate that information rationally. So part of that full disclosure includes the nature of the treatment, the risks of treatment, the alternatives to treatment, the expected benefits, and then also the potential harms from that, and also the potential consequences of doing nothing. And the person needs to comprehend the information that was disclosed. They need to act voluntarily, so they shouldn't be under any kind of duress or be forced into making a decision that they don't really feel comfortable making by a family member. And they need to consent to that proposed treatment, and often this is in writing. Informed refusal is similar to informed consent. What it is, is the individual's right to decline medical treatment or interventions after being fully informed about the risks, benefits, and alternatives. It's a key component of autonomy and informed consent, and you follow the same procedure as you do with informed consent, and you can look back at the previous slide. It's a voluntary decision, shouldn't be made with coercion or with pressure, and when somebody does refuse treatment, it's important to document this in the patient's record. Sometimes you might have them sign a form saying that they refuse, but it's important to document the discussion and the reason that you're not providing the standard of care to avoid claims of negligence. For example, you might have a patient who declined starting a medication for opioid use disorder, stating that they just want to detox. You might have heard of the Belmont Report. This is one of the basic documents related to bioethics in the United States. It was published back in 1979 by a national commission that met from 1974 to 1978, and these are basic ethical principles regarding the conduct of biomedical and behavioral research involving human subjects. The key ethical concepts are respect for persons, beneficence, and justice, and they developed guidelines to assure that research is conducted in accordance with these principles, so that included informed consent, assessment of risks and benefits, and selection of subjects. I mentioned this earlier, truth-telling. So an autonomous person has the right to know their diagnosis and their prognosis. Back maybe in the 50s and 60s, sometimes physicians wouldn't tell patients their diagnosis or their prognosis, and now there's been a shift. It's more the norm that you do tell most everybody their diagnosis and prognosis. There might be an individual who doesn't want to know, so people need to have the option to forego this information, but one needs to have accurate information to be able to exercise autonomy. Let's talk a little bit about confidentiality. This is the obligation not to disclose confidential information from a patient to another party without their consent. If confidentiality is not guaranteed, people may not seek treatment. This is especially true in highly stigmatized conditions like addiction. Patients must provide consent for their protected health information to be released, and this is in writing. This is through HIPAA and 42 CFR Part 2, and we're going to talk about these a little bit later on. So there are some exceptions to confidentiality, including if somebody is going to harm themselves or they have suicidal ideation and intent. There's also the duty to warn or protect, and this is when there's an imminent threat of serious bodily injury against a specifically or readily identifiable third party or parties. There's also cases where you have to report because of child abuse or neglect, sometimes elder abuse. Not all states have reporting laws for this, however. If there's a bona fide medical emergency and the substance use information is needed to provide appropriate care. And then also for public health reporting, however, 42 CFR Part 2 does not have an exemption for public health. For example, if a patient at an OTP declines to sign a consent to disclose their results for a positive hepatitis C test to the county health department, you can't report that. However, you could give de-identified data. So a bit opposite of autonomy is paternalism. So paternalism infringes on patient autonomy, and sometimes when we're being paternalistic, this can be enacted through deception, nondisclosure, manipulation, or coercion. Sometimes when somebody's being paternalistic, they believe that they're acting in the best interest of the patient, however, that physician's value system may not align with the patient's value system. And the physician can dismiss or overlook important cultural considerations for the individual, and that could cause some problems. And when you act paternalistically, you can lose the individual's trust by undermining their autonomy, and the individual may end up disengaging from care. So the goal is actually shared decision-making versus paternalism. There's a little bit of a difference, too, in paternalism. There's soft versus hard paternalism. So soft paternalism is when you act on the grounds of beneficence or non-malfeasance when a patient doesn't have autonomy. So this is ethically defensible when in line with the patient's values. So for example, let's say you have a patient that gets admitted to the hospital to stop drinking, they develop delirium, and you make decisions on the workup and the treatment and proceed with treatment of that delirium. There's also hard paternalism. So this is when the physician acts with intention to benefit the patient, but contrary to the decision of an autonomous individual. So the individual was fully informed, and they have the decision-making capacity. So this is unethical. And an example of this is when, let's say, you offer a patient viral hepatitis testing. They decline, but you order the test with their other labs anyway. I wanted to mention a little bit about social control and substance use disorder treatment. So sometimes patients feel pressured to enter treatment. This might be because of legal involvement, child protective services involvement, pressure from family or friends. Sometimes they come in because they were given an ultimatum. Sometimes people get into treatment to maintain their employment. And when a patient is pressured into treatment, you still need to respect the patient's autonomy and make sure that they're providing informed consent or refusal. So somebody who has social pressures to get involved in treatment can refuse treatment. And if they do so, they might have to face undesired consequences. So that could be going to jail, losing their parental rights. If they're married, they could be threatened with divorce or be estranged from their family, or they could lose their job. So I want to talk also about civil commitments for substance use disorders. So what this is, is family members or others, for example, healthcare providers, can seek court-ordered involuntary treatment for a person with a substance use disorder. They don't have to have involvement with the criminal justice system. It's not drug court. This is a civil matter. And this may involve hospitalization or community treatment or both. And the length of commitment varies by state and sometimes by substance. In 2015, there were 32 states plus Washington, D.C. that had laws permitting civil commitment for substance use disorder treatment. So some of the reasons behind this is because others can intervene before or after their loved one suffers severe consequences from substance use. So there could be concern that the individual will lose things they value, like their family or their job or their life. There's concern that the individual might be arrested, or sometimes people have concerns that the person is going to suffer a severe physical or psychological consequence because of their substance use. Now even when a state has a civil commitment law, it might not be frequently utilized. Some communities and states where laws do exist might not have treatment resources to provide treatment for the people who've been civilly committed. And lastly, there's limited data on the effectiveness of these laws. Next, I'd like to talk about fidelity. So fidelity is being faithful and loyal to the duties of a healthcare provider. And that means that you're going to adhere to professional code of ethics, adhere to professional practice standards, adhere to laws. You need to continue your education so you can provide patients with the best available balance of evidence regarding substance use disorders and treatment. You need to respect patient confidentiality. And there should be no conflicts of interest when recommending treatment, so no financial or philosophical conflicts of interest. For example, if you get an incentive for referring a patient to a treatment provider or program, or if you're philosophically opposed to opioid agonist treatment like methadone or buprenorphine. Fidelity also is important in terms of the relationship of a physician to society. So as physicians, we cannot misrepresent information regarding a patient for judges, employers, child welfare, the Department of Motor Vehicles, or government benefits. So you shouldn't be exaggerating these things. For example, to get your patient some government benefits. Recently, I had a case where a patient was asking me to falsify a report for the DMV. And I couldn't do that ethically. And you can't have dual relationships. So you can't have relationships outside of your treatment relationship with patients because the dynamics of the social relationship can interfere with providing care or the best interests of the patient. Okay, so moving on, let's talk a little bit about beneficence and non-malfeasance. So beneficence is the acting for the benefit of the patient. So you're preventing or avoiding harm by removing conditions that can cause harm. Non-malfeasance is the first do no harm. So you weight benefits against the burdens of all interventions and treatments to avoid those that are inappropriately burdensome and to propose the best course of action for that individual. And the last ethical principle that I'm going to be talking about is justice. So this is the fair, equitable, and appropriate treatment of all individuals. In healthcare, it's often the principle of distributive justice that's used. And access to healthcare is based on need, not ability to pay, social status, or other reasons. Scarce resources, such as equipment, tests, medications, organ transplants, should be equitably distributed. We heard a lot about this during COVID. Remember, there was a shortage of ventilators, so that was an ethical quandary. In terms of substance use disorders, an example would be that priority populations get admitted to programs first or if there's limited spots. So sometimes a priority population would be a pregnant woman or a person who's injecting drugs or a person with HIV. And healthcare resources and services are distributed fairly among all members of societies. So as far as healthcare funding, this could be affected by stigma related to addiction. And so it's important that the principle of justice is adhered to when making funding decisions. Okay, next I'm going to talk about some ethical issues with special populations. So I'm going to talk about older adults, adolescents, pregnant individuals, people in the criminal justice system, and impaired physicians. For older adults, the most common issue involves autonomy and decision-making capacity. Sometimes older adults might have fluctuating capacity. And in the cases of diminished capacity, somebody might have advanced directives. So a living will is one of those advanced care directives. And that's typically regarding life-sustaining treatments and organ donation, not so much about addictions typically. There's also the durable power of attorney or a healthcare proxy. And this is a legal document, and the person who's the healthcare proxy makes healthcare decisions for the individual if they're unable to communicate. And the healthcare proxy should be familiar with the person's values and wishes. And this is going to help in unforeseen circumstances where somebody didn't know, something they didn't plan for happens. Some people also might have a court-appointed guardian, and a guardian can control one or more aspects, like finances, managing the household, entering into contracts, as well as healthcare decisions. The next population is adolescents. So it's generally thought that around age 14, adolescents have the cognitive ability to understand information to provide informed consent. However, there's limited data on their ability to appreciate the information and make voluntary decisions. Therefore, it's not, states haven't universally had an age where adolescents can consent to treatment. However, in more than half the states, adolescents can consent to screening, assessment, and treatment of substance use disorders. Some states might list a certain age, like 12 or 14 years. Some may not have a certain age at all. There may be differences in consent for inpatient versus outpatient treatment. And there may be differences in mental health versus addiction treatment. In other states, a parent or guardian must be notified and or provide consent. So what happens if you are in a state where a parent or guardian must consent to an adolescent's treatment, but the adolescent doesn't consent for you to contact the parent or guardian? Well, if you're in a 42 CFR Part 2 program, that doesn't allow for the disclosure of information without patient consent, including adolescents, except in two cases. So first would be you'd have to notify the parent or guardian if there's a threat to life of the adolescent who's seeking treatment or to another individual when it's believed that the adolescent doesn't have the capacity to rationally provide consent to contact the parents or basically to refuse consent to contact the parents. And the second case would be the disclosure to the parent or guardian is necessary due to substantial threat to the life or physical well-being of the adolescent or another individual. So let's go back to that question. What if you're in a state where the parent or guardian must consent to treatment, but the adolescent doesn't consent to you contacting them? Well, first, you could try to get the adolescent to consent to their parent or guardian consenting. That would be the, well, it would be the best thing, maybe not the easiest thing. Next, you could treat the adolescent without obtaining the parent's or guardian's consent. So presumably, a parent would consent if their child needed treatment. And if the parent didn't consent and the physician thought the adolescent needed treatment, this could be a case where you can make a case for a child protective services involvement based on neglect. Now, one thing to keep in mind if you're treating an adolescent and don't have the parent's consent is that more intrusive treatments provide greater liability risk for the treating physician. So these would be things like inpatient treatment or medications. And the last thing you could do is if your adolescent isn't consenting for you to contact their parents is to refuse to treat them. So this is going to respect their privacy and autonomy regarding the decision to notify the parent or guardian, but it can violate the ethical principle to treat those in need. So it's a very ethically charged situation when you are legally obligated to get parents to consent for an adolescent's treatment, but the adolescent doesn't want you to. There's no real clear-cut answer here. The next population are pregnant individuals. It's important to screen all individuals for substance use during pregnancy using validated screening tools. This does not mean you have to do a urine drug test or any kind of toxicology testing. However, if you are doing any kind of drug testing during pregnancy, it's important to obtain informed consent. Now, professional societies and federal agencies universally endorse supportive policies and oppose punitive policies towards pregnant individuals who are using substances. And that's because laws that penalize people who use drugs and alcohol while pregnant can deter them from seeking prenatal care and addiction treatment during pregnancy. So states vary in the laws and policies regarding substance use during pregnancy. Some states have no laws. Some state laws and policies are supportive. They give pregnant people priority in accessing services and also require that programs don't refuse services due to pregnancy unless their services aren't appropriate. Some state policies are punitive and can involve the physician. Laws may consider substance use during pregnancy child abuse, grounds for civil commitment, or a criminal act. For example, one state has a law where if the physician has reason to believe a controlled substance was used for non-medical purpose during pregnancy, the physician shall administer without consent of the parent to the newborn a toxicology test to determine if there's evidence of prenatal exposure. And so you can see how that is really a violation of a person's autonomy as well as very punitive. Some states can have a mix of both punitive and supportive policies and laws. One last important thing regarding pregnancy is the Child Abuse Prevention and Treatment Act or CAPTA. So CAPTA provides federal funding to states in support of prevention, assessment, investigation, prosecution, and treatment activities related to child abuse. So for a state to receive funding, they have to have policies and procedures in place including appropriate referrals to address the need of infants born with and identified as being affected by substance abuse or withdrawal symptoms resulting from prenatal drug exposure or a fetal alcohol spectrum disorder, including a requirement that healthcare providers involved in the delivery or care of such infants notify the Child Protective Services system of the occurrence. So different states have different interpretations and policies and procedures regarding CAPTA, so it's important to know what your state requires. The next special population is people in the criminal justice system. So ethical issues abound here. First one is autonomy. So people who are in the carceral setting can feel coerced into either accepting or refusing certain treatments due to the power dynamic, and that raises issues with autonomy as well as informed consent. The next issue has to do with beneficence as well as non-maleficence. Sometimes prisons and jails do not offer medications for opioid use disorder, and this has been increasingly found in court cases as a violation of the Americans with Disabilities Act. And this is just violating both beneficence, so trying to provide good for the patient and reduce harms, as well as non-maleficence to prevent harms. So one of the pieces of information to think about here is that in the first two weeks after release from prison, there's three times the risk of overdose death than later on. So if we provide medications for opioid use disorder, we'd be preventing harm and hopefully preventing some of these overdose deaths. And then the last principle is that principle of distributive justice, because there's limited availability of treatment in carceral settings, and people who are incarcerated are more likely to have chronic health conditions, including substance use disorders, and they're at higher risks for HIV, viral hepatitis, as well as sexually transmitted infections. The last special population I wanted to talk about are physicians, and specifically physician impairment. Rates of substance use disorder in physicians are at least as high as those in the general population, and physicians have an ethical obligation to report impaired, incompetent, or unethical colleagues in accordance with the legal requirement in each state. I'm going to focus on impairment here. Physical, mental, and substance-related disorders that interfere with a physician's ability to perform professional activities competently and safely. So here are some signs of impairment. Deteriorating hygiene, increased absences from work or increased breaks, long times where you don't know where your colleague's at, emotional lability, increased errors, like putting in the wrong orders, incorrect prescriptions, clinical judgment is not what it usually is, they may be unresponsive to calls, like if they have an on-call shift at nighttime, or perhaps they might be on-call during the day and they're not responding. They may have a change in their attitude towards patients' well-being, and there might be complaints from patients about that physician's bedside manner or their care. If you believe that a physician cannot safely engage in professional activities due to impairment, it's your responsibility to ensure that they cease practicing in a timely manner, as well as receive appropriate assistance. So ethically and legally, you may need to report an impaired physician who continues to practice despite reasonable offers of assistance and a referral to a hospital or a state PHP, and what this may entail would be reporting them to a licensing authority. So this duty to report your colleague stems from a physician's obligation or your obligation to protect patients against harm, and it's going to supersede your colleague, their autonomy. I want to shift gears a little bit and talk about harm reduction in the United States and the ethical considerations. So here are some common harm reduction programs that we have regarding substance use disorders, so syringe service programs where you can go and get clean syringes if you're an injection drug user, and naloxone for overdose reversal, drug testing strips like fentanyl test strips or xylosine test strips. Opioid agonist treatment is often considered harm reduction, and then safer injection facilities, so these are facilities where somebody can go and inject drugs, and then they're monitored, they have a clean environment to do so, and then if they do have an overdose, they can be given naloxone and or medical attention. So let's talk about the ethics of harm reduction. The first principle I want to talk about is autonomy. So people who use drugs may act completely autonomously or may be influenced by varying degrees by their dependence on the substance or other physical or psychosocial factors. Harm reduction is seeking to return autonomy to the individual, whereas if you're using punitive strategies or mandated treatment, you're stripping a patient of autonomy. People who use drugs may engage in harm reduction modalities that reflect their values and their health goals. So they might get naloxone to avoid overdose death, or they might go to a syringe service program to avoid infection. Next is the principle of beneficence. So this includes interventions that promote health and wellness, even when it's not the ideal. So oftentimes the ideal in our society is to be drug-free or have a drug-free society or abstinence. But harm reduction is beneficent in that it's doing what's best for the patient within the confines of what the patient is willing to do. So an example of this would be methadone maintenance. Treatment with methadone decreases drug use, mortality, blood-borne infections. It also improves physical and mental health. It decreases criminal activities related to drug use. So it's very beneficent. Next we have non-maleficence. This includes interventions that reduce harm from drug use. So this would be things like syringe service programs, naloxone, methadone, buprenorphine. But these measures are often criticized because of the value that's placed on a drug-free society or abstinence being the goal or the supposed goal. It's also criticized as enabling drug use. There's concern that people will engage in more dangerous behavior when they have access to harm reduction, but that hasn't been borne out by data. So some examples of criticisms of these interventions would be people are gonna start injecting drugs if you make syringes available. If you have naloxone available, people are gonna use more drugs or they're gonna engage in more risky drug use behavior, kind of test the limits because they have naloxone available. And regarding methadone, you often hear people say, oh, well, methadone is just replacing one drug for another. So these are the criticisms of harm reduction in terms of non-malfeasance. Lastly, I wanna talk about the principle of justice. People who use drugs are often the most isolated from healthcare resources because of geographic reasons, economic reasons, or social barriers. And harm reduction programs can provide basic health and social services to individuals that suffer from many of the negative health and social consequences of substance use disorders. So for example, syringe service programs and opioid treatment programs offer resources such as HIV and hepatitis C testing, counseling, referrals to social welfare programs. Office-based opioid treatment and telemedicine can reduce geographic barriers for people who are socially isolated. Okay, so now we're gonna shift gears and talk about laws relating to substance use disorders. First off, I wanna talk about the Rehabilitation Act of 1973. So what this does is it forbids any government agency that receives federal funding from engaging in discrimination of any kind. So this applies to employers and organizations that receive financial assistance from any federal department or agency. So these organizations and employers could be hospitals, nursing homes, mental health centers, human service programs, so it covers a lot of entities. Section 504 of the Rehab Act protects qualified individuals from discrimination based on disability. So it's gonna forbid organizations and employers from excluding or denying individuals with disabilities an equal opportunity to receive program benefits and services. Disabilities are defined as physical or mental impairment, which substantially limits one or more major life activities. And this might be a current or if somebody has a history of a disability. And addictions are covered as a disability. Regarding employment, qualified individuals with disabilities are persons who, with reasonable accommodations, can perform the essential functions of the job. Next I wanna talk about the Americans with Disability Act. The ADA was passed in 1990 and amended in 2008, and this establishes equal opportunities in employment, state and local government services, public accommodation, commercial facilities, transportation, and so on, includes people with mental illness and addictions. And this protects people with disabilities from discrimination by social service agencies, child welfare agencies, courts, prisons, jails, medical facilities, homeless shelters, schools, colleges, and universities. And this prohibits discrimination against individuals who are recovering from an impairing medical condition, and it doesn't protect people who are using illegal drugs. I've included this chart here. This is looking at Americans with Disability Act and the Rehabilitation Act protections, looking at education or training programs as well as employment, any kind of exceptions in there if somebody is currently using substances or in recovery, what's protected. So you can take a look at this further on your own. Now let's just run through some ADA case examples. So first is a skilled nursing facility that refuses to admit a patient with opioid use disorder because they take prescribed MOUD, and the facility prohibits any of its patients from taking an MOUD. So this exclusion of patients based on their opioid use disorder would violate the ADA. Here's the second case, a jail that does not allow incoming inmates to continue taking MOUD prescribed before their detention. The jail's blanket policy prohibits the use of MOUD, and that would violate the ADA. If there's a doctor's office that has a blanket policy of denying care to patients receiving treatment for opioid use disorder, this office would violate the ADA if it excludes individuals based on opioid use disorder. Another case would be where a drug rehabilitation program asks a participant to leave because the participant routinely breaks a rule prohibiting the use of illegal drugs while in the program. Now this is not discrimination under the ADA because the program can require participants to abstain from illegal drugs while in the program. Here's a couple more examples. If there's an employee that has alcohol use disorder and an employee who doesn't have alcohol use disorder and they're caught outside on the loading dock drinking a beer, the employer fires the employee who has alcohol use disorder while giving the other employee only a written warning. So this is gonna be a violation of the ADA. While the employer can enforce its rules against intoxication on the job, it cannot selectively enforce its rules in a way that treats the person with alcohol use disorder more harshly. And I think lastly, this case is a mentoring program requires its volunteers to provide test results showing that they do not engage in the illegal use of drugs. The program dismisses a volunteer who tests positive for opioids for which the volunteer does not have a valid prescription. So this does not violate the ADA because the dismissal was based on current illegal drug use. So you might actually think of some of these cases because I'm sure that you've seen some patients who've had similar circumstances. The next law I wanna talk about is the Mental Health Parity and Addiction Equity Act of 2008. So this Mental Health Parity and Addiction Equity Act requires insurance groups offering coverage for mental health or substance use disorders to make these benefits comparable to general medical coverage. And this act originally applied to group health plans and group health insurance coverage, and it was amended by the Affordable Care Act to also apply to individual health insurance coverage. So with the Parity Act and Addiction Equity Act, deductibles, co-pays, out-of-pocket maximums, treatment limitations, out-of-network coverage for mental health and substance use disorders cannot be more restrictive than the same requirements or benefits offered for other medical care. So they can't have higher co-pays or fewer treatment days that they cover for addiction than they do for a medical condition like diabetes. Standards for medical necessity determinations and reasons for denial of treatment for denial of benefits relating to either mental health or substance use disorder benefits must be disclosed on request. So if an insurance company denies your patient something, they have the right to find out why they denied the request. Next, I want to talk about Consolidated Appropriations Act of 2023. So this is the most recent. And Section 1263 removes the requirement for providers who prescribe medications for opioid use disorder to obtain a waiver and implemented new education requirements for those prescribers. So this eliminated the data waiver that you needed to provide or to prescribe buprenorphine. And this became effective on December 29th, 2022. So no more data waiver is required, but starting June 27th of 2023, providers who applied for or renewed their DEA have to attest to completing at least eight hours of training on opioid use disorder or other substance use disorder, as well as the safe pharmacologic management of dental pain. So this is pretty specific. And another section of the Consolidated Appropriation Act that was important to addictions was 1264, which amended the Controlled Substances Act. And this amendment changed the number of days a provider has to administer controlled substances after they're delivered by a pharmacy. So previously, let's say you got a shot for an extended release buprenorphine injection, it came to the office and you only had 14 days to administer it before, but now you have up to 45 days to do so. The Health Insurance Portability and Accountability Act of 1996 establishes national standards to protect individuals' protected health information. So this applies to health plans, healthcare clearinghouses, healthcare providers that conduct certain healthcare transactions electronically. And it requires safeguards to protect the privacy of protected health information, and it sets limits and conditions on the uses and disclosures that may be made without an individual's authorization. It also gives individuals rights over their protected health information, including the right to examine and obtain a copy of the records. And it also allows them to direct a covered entity to transmit to a third party an electronic copy of their protected health information. And it also allows people to request corrections in their medical record. Next, there's CFR Title 42, Part 2. This is the section on confidentiality of alcohol and drug abuse patient records. So this has been around since the 1970s, and it protects the privacy of substance use disorder treatment records. It's been more restrictive than HIPAA due to concerns about discrimination and fear of prosecution, deterring people from entering treatment for substance use disorders. And one of the things about this is that substance use disorder treatment records cannot be used to investigate or prosecute a patient without written patient consent or a court order. Records can only be accessed with written permission of the patient to disclose specific information. Records are not to be redisclosed and historically have needed to be segregated in the chart. Now, these two things have changed a little bit, and I'm gonna talk about that in a slide or two. And that's because the Coronavirus Aid, Relief and Economic Security Act, or the CARES Act, which was enacted back in March of 2020, required the secretary of the Department of Health and Human Services to align certain aspects of Part 2 with HIPAA rules and also this HITECH Act. So there have been some major changes to Part 2, and these were announced on February 8th of 2024. Patient consent. Specifically, some changes are, one, that it allows a single consent for all future uses and disclosures for treatment, payment, and healthcare operations, which is commonly referred to as the TPO. It also allows HIPAA-covered entities and business associates that receive records under this consent to redisclose the records in accordance with HIPAA regulations. So remember, before, you couldn't redisclose them. It requires a separate patient consent for the use and disclosure of substance use disorder counseling notes. So these are gonna be more protected because a lot of times there's stuff in there that's not really needed for TPO reasons, for example, and it's gonna be very private, and so that has a higher level of privacy still. And it requires that each disclosure made with patient consent include a copy of the consent or a clear explanation of the scope of the consent. Some other changes regarding other uses and disclosures are as follows. It permits the disclosure of records without patient consent to public health authorities provided that the records that are disclosed are de-identified according to the standards established in the HIPAA privacy rule. And it restricts the use of records and testimony in civil, criminal, administrative, and legislative proceedings against patients, unless a patient consents or there's a court order. And here's a little bit more on substance use disorder counseling notes. The clinician can voluntarily maintain these notes separately from the rest of the patient's SUD treatment and medical record. And it requires specific consent for an individual to disclose these notes, and it cannot be used or disclosed based on the broad TPO consent. This is analogous to the protections that are in HIPAA for psychotherapy notes. And one last federal regulation to talk about is the Certification of Opioid Treatment Programs, or CFR Title 42 Part 8. So Part 8 involves opioid treatment programs. And SAMHSA's Division of Pharmacologic Therapies, part of the Center for Substance Abuse Treatment, is responsible for overseeing accreditation standards and the certification process of OTPs. And if you wanna learn more about these regulations, see the lecture on opioid treatment programs for a review of the federal regulations, which have been updated earlier in 2024. Okay, so that wraps up the information. Here are some resources for you. ACM did publish Medical Ethics in Addiction Medicine, so there's a web link there if you want to access that. There's also a web link for the Belmont Report if you wanna learn more about that. And then there's an article that I thought was interesting about mandatory and permissive reporting laws. And this is specific to emergency medicine physicians. And there's the citation there that you can look up. And that's the end of the presentation. Thank you so much for your attention, and good luck on the exam.

ethical principles

addiction medicine

autonomy

beneficence

patient confidentiality

federal laws

special populations

CARES Act