I'm Jason Schwab from Henry Ford Medical Group in Detroit, and I've been tasked with speaking to you about how new and evolving opioid legislation affects your neurosurgical practice. In terms of relevant disclosures, I'm past chair of the AANS-CNS Joint Section on Pain, a member of the AMA Pain Care Task Force, and I received salary support from Blue Cross Blue Shield of Michigan. So this is why we have all this new opioid legislation over the past three to five years, just by the numbers, and these are 2018 statistics. 130 people die every day from opioid-related drug overdoses. Two million people had opioid use disorder in 2018. 10 million people misused prescription opioids in that year, and about 800,000 used heroin in that year. So as you may know, we sort of reached a peak of opioid prescribing in 2012, but we're still dealing with the repercussions of longstanding opioid prescribing. You can see in this graph from the CDC, waves starting in the late 90s in opioid overdose deaths related to prescriptions, and then when we started clamping down on prescribing, you see skyrocketing rates of heroin-related overdose as well as rise in overdose deaths from synthetic opioids. And here you can see our latest statistics from 2017 show that there's wide variability across different states and different regions of the country in terms of per capita drug overdose death rates. To get more information about how this started, I highly recommend this book by Sam Quinones called Dreamland. It's really great and very illuminating. But as a result of the opioid epidemic, there are a lot of new rules and regulations. So in response to this national crisis, there's been a lot of new legislative and regulatory rules over the past three to five years that have been and will continue to be developed. All clinical staff need to be familiar with these requirements, and providers in particular need to be attentive to the requirements as it may impact your medical license in your state. I'm gonna talk a lot about Michigan just because that's where I live and practice, but look at what is going on in your own state if you live in another state. And even here, although the laws are a couple of years old, the interpretation regulations are still evolving. So I'm just gonna go through the most recent iteration of the CDC guidelines from 2018. The full guidelines can be found at the website noted below. But in general, opioids are not first line or routine therapy for chronic pain. Treating a number like six out of 10 pain or 10 out of 10 pain is not appropriate. Goals for pain and function should be assessed. Benefits and risks and availability of non-opioid therapies should be discussed with the patient. And in general, you need to start low and go slow with opioids, and use immediate release opioids, not extended release long-acting opioids for acute pain. When prescribing for acute pain, don't prescribe more than is needed. Patients require follow-up and risk reevaluation to make sure that they're not having problems. And for patients who seem to be at risk of opioid abuse or misuse, the dosage should be reduced or even discontinued via taper. Part of this job in prescribing opioids is evaluating the risk factors for possible opioid-related harms, checking prescription drug monitoring programs that are present in almost all states for high dosages and prescriptions from other providers, using urine or sometimes even serological drug testing to identify prescribed substances and undisclosed use. This is not only to make sure that the patient's not taking something else that you didn't prescribe, but also to make sure that they are actually using the medication and not selling it on the street or diverting it in some other way. You should avoid concurrent benzodiazepine and opioid prescribing. And for a patient who's identified as having opioid use disorder, it's incumbent upon the provider to help arrange treatment. So I'm gonna talk a little bit about different regulations, and there are a number of different agencies that are promulgating regulations about opioid prescribing. The Joint Commission, if you subscribe to the Joint Commission for your accreditation, has a lot of different regulations, and they're different for different settings. And this can be for ambulatory care if you're a private practitioner or behavioral healthcare, critical access hospitals in rural areas, other hospitals, nursing care centers, office-based surgeries, and home health services. Just for example, I'm gonna go through some of the regulations for ambulatory care. You should go to the website on the slide before to look at specific regulations that might apply to your practice setting. But in general, there's a requirement by Joint Commission that the organization has a leader or leadership team that's responsible for pain management and opioid prescribing, as well as developing and monitoring performance. The organization is required to provide staff and licensed independent practitioners with educational resources to improve pain management and safe use of opioid medications. The organization is required to provide information to staff and licensed independent practitioners on available services for consultation and referral of patients with complex pain management needs. The organization facilitates practitioner and pharmacist access to a PDMP database. The organization has defined criteria to screen, assess, and reassess pain that are consistent with the patient's age, condition, and ability to understand. The organization treats the patient's pain or refers the patient for treatment somewhere else. The organization is required to develop a pain treatment plan based on evidence-based practices and the patient's clinical condition, past medical history, and pain management goals. And there's more. The organization is required to involve patients in pain management treatment planning. This is not a patriarchal system where you just tell the patient what to do. Patients are to be consulted and worked with to develop realistic expectations and measurable goals that are understood by the patient for the degree, duration, reduction of pain. There's supposed to be a discussion of the objectives used to evaluate treatment progress, and patients are to be provided education on pain management treatment options and safe use of opioid and non-opioid medications when prescribed. Based on the patient's condition, the organization is required to reassess and respond to the patient's pain through evaluation and documentation of responses to pain interventions and progress towards pain management goals, including functional ability. The organization is required to educate the patient family on discharge plans related to pain management, including the plan of care, side effects of pain management treatment, if applicable, activities of daily living that might exacerbate pain or reduce effectiveness of the pain management plan of care, and safe use, storage, and disposal of opioids when prescribed. And the organization is also required to monitor the use of opioids to determine if they are being prescribed safely. Before we move on to some of the other regulations from different agencies, I did want to show this graph from the CDC from 2017, because a lot of the regulations have to do with the amount of medication prescribed, and this is why. It's sort of like supersizing. And we all have seen this. I know when my parents were kids, a normal soda size that you would get from a vending machine or from a store was eight ounces. Now it's hard to find one that's under 20 ounces. And the more you get or the more you give, the more people use. That's just human nature. And so as you can see from this graph, the more that's given, the higher the rate of patients still using opioids one year and three years after they were given them. And for us as surgeons who are often exposing patients to their first set of opioids after surgery, this has to be considered one of the highest complications in the surgeries we do. So just for different regulations, as a result, CMS has restricted medications to a seven-day supply for opioid-naive patients. There are opioid care coordination alerts so that the provider is contacted by Medicare if a patient is prescribed more than 90 morphine equivalents a day. And drug management programs may be implemented. So a provider will be contacted if a patient is deemed at risk. For example, if there are multiple prescribers or a concurrent prescription for benzodiazepines. And as a result, patients may be required to use a single pharmacy for their opioid prescriptions. That's called a pharmacy lock-in. Or a single prescriber, which is called a prescriber lock-in. So that's the regulation for CMS, but maybe different for other insurers. So just for example, this is Blue Cross Blue Shield of Michigan, which is the largest private insurer in our state. And they have a more stringent requirement. They have a supply limit of only five days for the first prescription, and then 30 days for subsequent prescriptions. And so as you can see, it can be a little bit difficult to navigate the different plans and different restrictions from the different insurers based on what your patient is carrying. Then there's the DEA. And the DEA has different regulations. So for Schedule II medications, they say that an individual practitioner can actually issue multiple prescriptions, authorizing the patient to receive a total of up to 90 days supply of a Schedule II controlled substance. And the way this is supposed to be done is the practitioner must sign and date multiple prescriptions as of the date issued, but write on each separate prescription the earliest date on which the prescription can be filled. Pharmacy has no ability to use their judgment to change this date, or dispense a Schedule II medication to a patient prior to that date. But all these rules are superseded if there are different state laws and regulations. For Schedule III through V medications, the DEA says that early dispensation is allowed unless it's prohibited by state law. And as you can see here, there's a lot of variability from state to state. This is from a website of National Council of State Legislatures that sort of put everything together. And there are different limits in different states. And this was the most up-to-date graph that I was able to find as of May 2020. So although time prohibits going through the different regulations for all 50 states, I thought it'd be useful to talk about Michigan as an example. Governor Snyder, who was our governor at the time, developed a Prescription Drug and Opioid Abuse Task Force. And at the time, we ranked 10th nationally in per capita prescribing rate of opioids. The legislature pushed through 13 bills prescribing a number of different regulations. and this was signed into law between Christmas and New Year's in 2017, despite concerns from the Michigan Hospital Association and the Michigan State Medical Society. And in essence, the legislature was concerned that providers and hospitals had not done enough to curb the opioid epidemic. And I think the big caveat and big warning here to practitioners, and this is true in many states, is that failure to comply with state regulations may result in revocation of a state license for prescribers. So first, the PDMP system, all prescribers are required to register with PDMP. That includes residents, advanced practice practitioners, and before prescribing or dispensing controlled substances that are greater than a three-day supply, the prescriber is required to obtain and review a PDMP report concerning that patient. That may be integrated into your electronic medical record. It may require you to go to a separate site. This is only for patients that you're sending home, at least in our state. It is not required to search a PDMP for an inpatient. And this is all controlled substances, not Schedule II alone. So this includes other things like Lyrica, gabapentin, testosterone, even Schedule V medications. And there's a requirement that there be a bona fide relationship between the prescriber and patient before a prescription for any scheduled medication can be provided. And this means that a provider has reviewed the patient's relevant medical or clinical records and completed an assessment of the patient's medical history and current medical condition, including medical evaluation of the patient conducted in person or through telehealth. It requires the provider to create and maintain records of the patient's condition in accordance with medically accepted standards. So this was very stringent to begin with, and we were trying to figure out how this was going to work for cross-coverage. But fortunately, the state has come out with subsequent amendments that delineate exceptions for on-call coverage and medical emergencies and a few other conditions. For children, there's a requirement of parental consent for any opioid prescription, and there's a statewide start talking form that's provided by the health department for minors before receiving their first prescription of a controlled substance containing an opioid. So you don't have to necessarily give it for a refill, but for that first prescription you do. If another adult, not a parent or guardian with authorization to consent for treatment is the person signing, the prescription cannot exceed a single-time 72-hour supply. And the only exception is in case of emergency if it's detrimental to the minor's health. In terms of the seven-day prescribing limits, there's a prohibition against filling prescription for Schedule II controlled substance for more than 90 days after the prescription is issued. The pharmacist can partially fill in increments of prescription for a controlled substance, for example, that you can give three of seven days and the patient can return for the remaining days, but you have to be conscious of the fact that the insurers may not go for that and that may not comply with their policies. This is important for treatment of acute pain. A prescriber cannot prescribe more than a seven-day supply of an opioid within a seven-day period. That includes invasive procedures like surgery, trauma, or disease. Even if you know that based on the surgery you've done or the trauma the patient suffered, you expect the patient to have more than seven days of pain or requirement for opioids. And this also does not include patients who already have an underlying chronic pain and then have an acute injury. And frankly, we don't really know how we're supposed to handle that. Chronic pain is defined as pain treated with opioids for more than three months. And contact with the patient is required to assess status and pain control at seven-day intervals in order to dispense more opioids. So it's really unclear how you separate out acute and chronic prescriptions at this time, even a couple of years into this. Some sort of evaluation will be needed and documented for every seven days for acute opioids. And although the DEA permits it in the state of Michigan, prescriptions are not allowed to be predated. There is mandatory patient education on opioid risk, and this fulfills the joint commission requirement with after-visit summaries being prompted, especially with electronic medical records, for any patient to discharge on an opioid or with an opioid in an active medication list. The patient's signature is, again, must be obtained on a start-talking form that's provided by the state, attesting that the patient received opioid education at the time of providing any opioid prescription that's new. So for a refill, you don't have to do that. But let's say you have a patient that you're prescribing oxycodone 5 mg acetaminophen 325 mg pills, and you want to change that to oxycodone 7.5 mg. Then you have to do a new form. And the form is supposed to include information about the dangers of opioid addiction, how to properly dispose of opioids, notification that diversion is a felony, that there are issues with potential damage to a fetus if the user is pregnant, and the exceptions of inpatient and in-facility treatment. The form must be completed. It can be passed off to another provider. It doesn't have to be the prescribing practitioner in our state. In theory, the pharmacist could obtain the attestation, although in general, we do it or our nurses do it or our residents. And this includes adult education and pediatric consent in multiple languages. There's also a law on post-overdose patient education, which doesn't affect neurosurgeons so much. It more affects our emergency medicine colleagues. So any patient coming in with an opioid-related overdose is required to be given information regarding substance use disorder prevention and treatment services. And a lot of the work has been done to make sure that eligible individuals can receive coverage for opiate treatment options. The state has mandated CME of three hours in pain and pain symptom management for all providers undergoing renewal of their license, and there are separate requirements for providers obtaining their first license in the state. From a congressional point of view, there was this law, HR 6, that was signed into law in October of 2018. There was a lot of debate about this before it went through, and there were multiple different iterations in both the House and the Senate. But in the end, this was the bill that went through. It increased resources to develop prescribing guidelines. It increased resources and coverage for substance abuse treatment. It increased access to drug disposal. And a lot of the law revolves around charging the Department of Health and Human Services and the Center for Disease Control to develop and promulgate best practices. No specific prescribing limits were placed in the law, although there was a lot of discussion about that beforehand. And the main reason for that was a lot of action, especially by neurosurgery from our PAC, from the Washington Committee, from the Council of State Neurosurgical Society, and from the AMA. So there's been a lot of advocacy from the AANS and CMS, and a lot of that has been around avoiding hard limits on opioid prescribing for post-operative patients. We've been very sensitive to this because, especially for spine surgery patients, only about 25% of them are opioid naive. So making regulations that apply to every single patient, regardless of whether they're opioid naive or not, is really probably not the best way to practice medicine. We've also advocated for partial prescription fills, so patients don't have to fill a large prescription but can come back for later if they need more, if it's prescribed by the provider. We've encouraged the use of evidence-based surgical treatments for pain and worked to streamline the preapproval process for neuromodulation procedures. We've also advocated for optimizing the use of prescription drug monitoring programs. So I just want to go through a couple of the issues related to the COVID pandemic. The DA has put out a statement that's loosened some of the requirements while the pandemic is going on. Your state may or may not subscribe to this. I know Michigan did put out a letter saying that they were going to allow these new exceptions, and a lot of it is based upon whether you have a previous relationship with that patient that you've been prescribing opioids to. So as you can see here on the top row, if you do have a relationship, you're still required to evaluate the patient, but that can actually be done by telephone before prescribing medication. If you don't have a prior relationship as a prescriber for a patient, it's going to depend on whether you're prescribing buprenorphine. That's generally not an issue for neurosurgeons. We're usually not doing that. And in that case, you are required to have some sort of evaluation. Telephone evaluation or email is not sufficient. You have a choice of either in-person or via telemedicine. And then you can issue any needed prescription directly to the patient or to the pharmacy. There are some rules about buprenorphine that we've actually advocated. There is quite limited who can prescribe it, which seems a little bit too stringent to many of us who are advocating for more treatment for these patients. But you should know that any practitioner can administer buprenorphine for a patient who's going through acute withdrawal so that they don't have to go out and get opioids or potentially go and buy illicit heroin or carfentanil or other opioids on the street. So even if you have not gone through the federally required Drug Addiction Treatment Act 2000 training that is eight hours long to prescribe buprenorphine for a treatment of opioid-related substance abuse, you can give buprenorphine for such a patient, but only for 72 hours to sort of stabilize matters. So no more than one day's medication can be administered or given to a patient at one time. So essentially, you have to speak or interact with the patient every day and see how they're doing. But you're capped at 72 hours, and that can't be renewed or extended. So just in conclusion, I think the take-home messages are that you have to be very cognizant of the different regulations. There are a lot of them, and they come from all directions. And it comes from insurers, from your state government, from the DEA, and if you use the Joint Commission for Accreditation, from them. However, I would say, as you can see from the other talks, that reducing opioid use does not mean that patients should be abandoned and be told that they should just live with their pain. And in general, I think neurosurgeons need to become comfortable with prescribing other modalities to effectively treat pain. Thank you for your time.

opioid legislation

neurosurgical practice

opioid misuse

prescribing guidelines

regulations

patient safety