Speaker 1: Hi, this is Dr. A and this is your second lesson in healthcare laws for chapter 11 of the fifth edition of Basics of the U.S. Healthcare System in our Integrity U.S. Healthcare course and we're going to look at the provider-patient relationship, we're going to look at informed consent in the patient field of rights. Okay, so let's start with a relationship between the provider and the consumer which is a patient. So a physician can establish this relationship with a patient in three ways. So first, establishing a contractual relationship to care for a designated population. That's usually the model of managed care. You sign up to care for this group of managed care employees and so therefore there's already there's a contract because you have a contract with the managed care organization. Establishing an express contract with a patient under mutual agreement. This is typical, you go get established at a clinic with a primary care provider and you signed paperwork to say that this doctor now is your primary care provider. So that is an equal agreement, both in agreement that the relationship is going to exist. And then you can establish a relationship under an implied contract and we're going to look at this here in a second. Okay, so the relationship between a patient and the hospital is a contractual right to admission and it can be considered a contract if a hospital has contracted to treat certain members of an organization like a managed care organization. So again, if the managed care organization has a contract with the hospital to care for their patients, you already have a right to admission to this hospital. A second example of this type of contractual right to admission is if governmental hospitals such as county hospitals are required to provide care for patients regardless of ability to pay, you have to be admitted if you need care. And a contract to care for a designated population is always indicative of an HMO or a managed care type of contract. So a physician then is contractually required to care for those members of that managed care organization and you know because as long as you're in a contract with that managed care organization. Again, the express contract is a simple contract and is merely a mutual agreement of care between the physician and the patients. This is the typical contract. The physician can also define the limitations of the contract which would include the parameters of care. So this could happen for example if you have to have surgery. So you have to have surgery, let's say you have to have gallbladder surgery and you're going to go see the general surgeon that's going to do this and you're going to have a contract of care for that procedure you know through completion and you know through maybe through discharge and those will be the parameters of care and that contract will be limited and then after you discharge from the care of this surgeon then your care would return back to your primary care provider. Now let's talk a little bit about an implied contract. So an implied contract it can be implied from the physician's actions. So this is where you have to be very careful if you are a provider of care. So if you give advice regarding medical treatment then there's an implied contract especially if you have the ability to provide care if you're a provider if you're a doctor. So you have to be really careful what you say to patients if or to people or friends or family because if you give them medical advice then they may then become your patients under an implied contract. So how does a relationship with a provider end? To protect the physician from being accused of patient abandonments the physician must take steps to properly end the relationship. So if a patient withdraws from the relationship with a provider then the physician no longer has a duty to provide follow-up. So let's say a patient relocates they move or they just don't like the physician they want to get a different one or they change networks or something like that and they have to get a different physician. It is you know the physician does not have to chase the patient or anything like that the patient is free to move on to a different provider. Also if medical care is no longer needed the relationship isn't actually completed. So again those are often the case usually with limited contracts and contracts for a surgery a procedure a specific length of treatment of physical therapy or something like that once this all the sessions are completed and the contract is completed and that relationship is completed. So if the provider however opts to terminate a patient's relationship so they no longer want to be the doctor for the patient maybe the patient is non-compliant right that could happen. Legally the provider has to inform the patient in writing and give them ample time to look for another provider. The time varies by state guidelines and a provider can also offer to support search for a new provider. So again this could be from disagreement but it could also be if the provider decides to relocate. What if the provider decides they you know they want to move their family to a different state or relocate relocating for personal reasons and so there they have a duty to notify all other patients in writing and usually there if they're leaving a practice somebody's going to take their place and so they can say Dr. Sessions is going to take my place you're free to establish yourself with them or go find you know another provider. So but it has to be in writing you have to give ample warning and time for patients to be able to find another provider. So let's look at some health care related legislation. So some health care consumer laws. We have the Hale-Burton Act of 1946. So federal grants were provided to states for hospital construction to ensure there were 4.5 beds per 1,000 people. So this caused a little hospital boom a lot of little county hospitals and state hospitals were built. The EMTALA which is the Emergency Medical Treatment and Active Labor Act requires Medicare participating entities so these would be usually hospitals right to provide emergency care for a life-threatening condition if that entity or that hospital or clinic whatever it provides dedicated emergency services. So if you have an emergency room and you see patients in your emergency room and you participate in billing Medicare to have Medicare patients you fall under EMTALA. Facilities can be fined thousands of dollars for not adhering to the EMTALA laws. So if somebody shows up to your ER needing care, needs stabilization, if their condition is life-threatening you have to care for them or they're in active labor you have to accept them. And so we see that sometimes with patients that have no prenatal care to show up in labor at whatever hospital of their choice in labor and you have to admit them and deliver. So next we have the Children's Health Insurance Program. This was enacted under the Balance Budget Act of 1997, Title 21 of the Social Security Act. It is jointly financed by federal and state funding and administered by the states and by CMS which is the Center for Medicare and Medicaid Services. So the purpose of this program was to provide coverage for low-income children that were younger than age 19 whose family income exceeds the income level requirements of Medicaid even with the expanded Medicaid. So it's meant to catch at least the children and families that are in this gap where they make too much to qualify for Medicaid but oftentimes are in jobs that don't pay enough or don't have good benefits and they don't have good or don't have any employer-related health insurance. We also have the Benefits Improvement and Protection Act of 2000. It was formerly called a Medicare, Medicaid, and CHIP Benefit Improvement and Protection Act. It modified Medicare payment rates for many services. It added coverage for preventive and therapeutic services and increased federal funding to state programs. Let's talk a little bit about HIPAA National Standards. So this is the Health Insurance Portability and Accountability Act, HIPAA, 1P2A. A lot of people do 2P1A so it's 2A, right. It was passed in 2002 to protect the patient's personal medical records and other personal health information that is maintained by health care providers, hospitals, insurance companies, and health plans. And this is for you to be able to choose who gets to have access to your health records and to keep your information private. And so this is a federal law and people that violate this commit a felony and this can be heavily fined. So if you are a health care employee, it is very important that you don't go wander into charts that you don't have any business being in. Next we have some antitrust laws. So the purpose of antitrust laws is to protect consumers by ensuring there is a market-driven back competition so consumers have a choice for health care. So you have to have access to hospitals, different hospitals that are owned by different systems. So we have two systems in our town and with other hospitals nearby that are owned separately or whatever. The Sherman Act of 1890 prohibits monopolies which means that one organization cannot dominate a market which therefore would eliminate consumer choice. And this applies to health care but also the entire industry marketplace business. It also targets price fixing among competitors that prohibits consumer from paying a fair price because the competitors establish a certain price amongst themselves to stabilize the market. Sometimes that can be seen with gas stations, gas prices and things like that where there's an event or something there's an increased need and if all of the gas stations in an area decide to all fix the price at a certain dollar per gallon and they all do it together to increase their profits, it eliminates then choice for the consumers. And so same thing in health care. We can't do any price fixing. The Sherman Act also prohibits the following. So it prohibits market division which occurs when one or more health organizations decides which type of services will be offered at each organization. So it could be something like when this you know organization says we'll do all your radiation oncology treatments and the other organization doesn't do any so therefore if you have to have let's say radiation oncology you only have the one choice right and they decide amongst themselves so I'll do all of this you do all of that and then that's market division. Tying refers to the healthcare providers that will only sell a product to a consumer who will also buy a second product from them. So you can like think of that like the fast food meals kind of idea of like bundling things together. If all your option was when you went to a fast food was to purchase the meal that's would be tying if you didn't have the option to just purchase a sandwich separately right so it's kind of the same thing. Boycotts, this is when the health care providers have an agreement to not deal with anyone outside their group. It is considered interfering with the consumers right to choose so those are not allowed also in health care. Declayton Act placed restriction on hospital mergers and acquisitions and allowed individuals to sue for three times their actual damages plus legal cost. Again so it you know if hospitals merge and acquire and grow into big networks it could take over all of the entities in an area and eliminate choice right. So the Hart Scott Rodino Antitrust Improvement Act of 1976 was an amendment to the Clayton Act. It ensured that those hospitals and other entities that have entered mergers, acquisitions or joint ventures have to notify the DOJ, Department of Justice and FTC, the Fair Trade Commission before any final decisions are made. It might be sorry it might be Financial Trade Commission. Either way it's the organizations that will look and see if these mergers or acquisitions or joint ventures violate the Clayton Act or the Sherman Antitrust Act. So now let's move on to informed consent. So informed consent is based on the patient's right to make an informed decision regarding medical treatment. This is a legal requirement in all 50 states and the provider is responsible for discussing these with the patient. So the provider must discuss a diagnosis if it has been established if we have a diagnosis right. The nature of the proposed treatment or operation including the risk and benefits of such, any alternatives that are possible and the risk and benefits of the alternatives and then also the risk and benefits of not doing any of it. So if you don't do any procedure or treatment because it is a choice it is a choice that you have but your provider has to give you all lay it all out everything. And if a patient did not provide informed consent meaning they really didn't know what they were agreeing to for a procedure or treatment it is considered a case of negligence. So it's negligence on the part of the provider of providing the information that was needed for a patient to make that determination. A medical emergency may eliminate the need for informed consent if the patient cannot clinically give consent maybe they're unconscious right and they need a life-saving medical treatments we can assume statutory consent which presumes a reasonable person would give consent to the life-saving procedure. So you would want that to stay alive and if you're not able to give consent they will often try to get consent from the family if there's a family member that is with that patient but sometimes that may not be the case and so we do life-saving procedures on the patient even without their consent because that's what a reasonable person would want done. Consent could be applied in a non-emergent situation if a patient volunteers for a procedure that would imply consent even without an oral or written verification if you step forward and volunteer to have something done. The patient might be considered to have given informed consent if they are a volunteer. So to determine what constitutes informed consent two legal standards are applied. There's a reasonable patient standard it focuses on a patient's information needs including the risk and benefits that allow the patient to make that decision. So what would a patient want to know to make this decision? The reasonable physician standard focuses on the standard information that would be given by any physician to a patient contemplating the same procedure or treatment or what would a typical physician share with the patient about that procedure. So most states utilize a reasonable patient standard probably also because I would think the patients have the lower education level and stuff and so it's better to make sure that we meet that standard because that's someone that's probably the most applicable to most people. So lastly tied to this we have the patient bill of rights. So the patient's self-determination act of 1990 requires hospitals, nursing homes, home health providers, hospices, and managed care organizations that provide services to Medicare and Medicaid eligible patients to supply information on their patients rights to patients upon admission. So you do have a right to also disinformed consent to knowing everything that's going on to have access to your medical records and this applies to virtually every type of health care facility. So the facility must provide adult patients with written information under state law about making health care decisions. So they often give you the papers it's like here's what we saw you for, this is what we did, this is the follow-up, it's all that has to be printed and written format and handed to the patient. So this is based on the concept of informed consent. In 1972 the Board of Trustees and the American Hospital Association developed this patient bill of rights. So it states that the patient has a right to all information from his provider regarding any testing diagnosis in treatments. This information must be provided to the patient in terms that the patient will be able to understand. And so this is very important to really provide true informed consent. The information, the documents that are given that are printed and given to the patient must be on their reading level, on their educational level. And so for the the average public that's like third to fifth grade level writing. So things have to be clearly written and you can't use a bunch of medical jargon or if a certain medical term is put that you have to have the definition so that people understand what it is. And even when you communicate orally with patients you have to be careful not to use a bunch of terminology that's common to your practice but that your average person may not understand. So you have to always break it down in terms that you're you know like it just explain it like you would explain it to your kids without belittling the patient and you should be fine. So anyway that wraps up this little section on health care law. We've got two more and I'll see you in the next one.