The Opioid Epidemic in Public Policy

The Opioid Epidemic in Public Policy A graduate project submitted in partial fulfillment of the requirements For the degree of the Master of Public Administration, Health Administration ii _ iii Table of Contents Signature Page……………………………………………………………………………………iii Abstract ........................................................................................................................................... v Introduction ..................................................................................................................................... 1 Background ..................................................................................................................................... 3 Methodology ................................................................................................................................... 5 Literature Review ............................................................................................................................ 6 Prescription Drug Monitoring .................................................................................................... 6 Physician Regulation.................................................................................................................. 9 Medicare and Medicaid ............................................................................................................ 10 Overdose Deaths ...................................................................................................................... 11 Socioeconomic Impact .............................................................................................................. 14 CARA....................................................................................................................................... 16 CARA 2.0................................................................................................................................. 20 The Role of Public Policy ........................................................................................................ 23 Politicans and Health Care Professionals ................................................................................. 25 Policy Implications ....................................................................................................................... 27 Conclusion .................................................................................................................................... 29 References ..................................................................................................................................... 30 iv Abstract The Opioid Epidemic in Public Policy In the United States, the most common drug attributing to overdose deaths are primarily synthetic opioids. Drug overdose mortality rates related to opioids have increased by more than 44% in recent years according to the National Institute on Drug Abuse (NIDA), causing controversy around the opioid epidemic. There are public policies in place surrounding prevention and treatment of opioid addiction, yet our country continues to experience an increase in addiction and death rates. Why are the existing public policies failing to address this epidemic? This review of the literature examines whether a lack of public policies is contributing to the failure to address the increased rates of opioid addiction. The epidemic stems more so from a lack of compliance regulations and not enough oversight of pharmaceutical companies, as v well as an increase in supply and demand resulting in profit. The Centers for Medicare and Medicaid Services (CMS) have placed more stringent requirements on compliance regulation following quantitative and nonquantitative case studies, resulting in more hefty compliance regulations and mandated reports to CMS. Ironically, Medicaid insured patients are associated with high levels of opioid abuse. Considering that opioid use is higher in areas of those who are socioeconomically disadvantaged, there may be a correlation tied to higher levels of abuse for Medicaid insured patients. The significant increase in drug overdose suggests that public policies have lacked substantial impact in preventing and treating addiction, deeming the current strategy as ineffective. The Comprehensive Addiction and Recovery Act (CARA) is the most current comprehensive public policy on drug prevention and treatment; however, it has failed to distinguish opioid addiction as a health disease. There is an apparent lack of influence and sense of urgency. An addendum to the CARA Act outlining both proactive and supportive measures required by politicians, health care professionals, and law enforcement would be highly influential because it would force accountability of those in positions to lead change. The controversy surrounding opioids and the fact that many Americans are succumbing to opioid drug abuse, prompted me to conduct an in-depth literature review. By classifying opioid drug dependency as a health condition in public policies, there will be more attention drawn to the need for urgency and drug prevention. The United States government must implement public policies with more specific guidelines and proactive measures to combat the epidemic. vi Introduction In the past decade, there has been an uproar about the use of opioid drugs. Due to strong potency levels and relative ease in accessibility, opioid substances have become popularly used by many to treat legitimate medical conditions, as well as for recreational use. According to the National Institute of Drug Abuse (NIDA), opioids are a diverse class of moderately strong painkillers often sold or physician prescribed under various trade names such as; Hydrocodone (Vicodin, Norco), OxyContin, Codeine, Morphine, and many other names including synthetic opioids such as fentanyl and the illegal drug heroin (NIDA, n.d.-a). Depending on the pain level being treated the type of opioid sold or prescribed may vary. Some are naturally part of the opioid drug family, while others such as fentanyl are classified as a synthetic opioid. The NIDA (n.d.-b) describes fentanyl as an extraordinarily strong pain killer, which is synthesized to resemble other opiates such as morphine; however, it is 50 to 100 times more potent. Most often it is an alternative treatment for patients who suffer from chronic pain following a surgery, where there is tolerance to other opioids (NIDA, n.d.-c). Opioids in general are publicly known to have a high risk of addiction and overdose. However, the NIDA (n.d.-d) reports that the most common drugs attributing to drug overdose deaths in the United States are primarily synthetic opioids including fentanyl, highlighting that in 2017, 59 percent of drug overdose deaths were related to synthetic opioids including fentanyl in comparison to 14.3 percent reported in 2010. The data reveal a 44.7 percent increase in drug overdose mortality rates over a span of seven years, which has contributed to the controversy surrounding the use of opioids. The increase in drug overdose death rates is puzzling, considering that there are public policies addressing opioid addiction. While there are public policies to help prevent and treat addiction, there is an apparent gap in solving the opioid epidemic. Instead of seeing improvement, the crisis is getting worse. The significant increase in 1 drug overdose suggests that the public policies in place are ineffective. Therefore, this study reviews the literature to assess whether existing public policies need revisions to successfully reduce the number of opioid overdose deaths. 2 Background To address the opioid epidemic, the Centers for Medicare and Medicaid Services, Food and Drug Administration, Centers for Disease Control and Prevention, and many health regulated entities nationwide have placed limitations and restrictions on prescribing opioids as a proactive measure to minimize the risk of addiction and overdose. Some of the limitations and restrictions include reduction in dosage amounts and prescription alternatives. Having worked in healthcare for several years, there was a spark of inspiration to research some of the obvious issues our country is facing with prescription drug monitoring, the most controversial of which is seemingly opioids. While the intent for limiting use may be driven by positive reasons, there has been an abundance of backlash from consumers who rely heavily on opioids to treat chronic medical conditions. Some argue that while they understand the epidemic of individuals abusing the drug, there are also many patients who need the drug to alleviate pain associated with chronic illnesses. This conflicting stance seems to overshadow the seriousness of the opioid epidemic. The Centers for Medicare and Medicaid Services (CMS) is a federal agency in the United States Department of Health and Human Services. CMS recently launched a strategic initiative to aid in fighting the opioid epidemic. According to CMS, the focus of the initiative will be to decrease the rate of opioid use and death rates associated with opioids by prevention of overuse, increasing accessibility to treatments, and focusing on improvements by analyzing data (2019-a). Possibly, limiting prescriptions alone does not necessarily eliminate addiction, so maybe an increase in benefits, services, and resources for those who battle addiction is needed or more detailed public policies. CMS outlined their Opioid Strategy by sharing their focus on three key areas as part of their initiative to empower patients in a way that will allow them to make more responsible and informed decisions for themselves and their families through prevention, treatment, and data as outlined below: 3 o Prevention: preventing and reducing opioid use disorder (OUD) by promoting safe opioid prescribing and encouraging non-opioid pain treatments o Treatment: increasing access to evidence-based treatment for OUD; and o Data: leveraging data to target prevention and treatment efforts and to support fraud, waste, and abuse detection (2019-b) Perhaps, the opioid epidemic can be controlled, or at least somewhat contained, through targeting these three parameters. 4 Methodology This study is a qualitative analysis of archival data of peer reviewed journal articles. Primarily, I used JANSTOR and PROQUEST databases to conduct my research. In addition, my review consisted of non-peer reviewed government websites including CMS, NIDA, CADC, CARA, and the USFDA. The keywords used for peer-reviewed journal articles consisted of opioid addiction, drug overdose, opioid addiction, drug prevention, and opioid epidemic in public policy. Considering the opioid epidemic has peaked in recent years, the journal articles used required relevancy in terms of dates and content. The CARA was signed into law in 2016, is the most recent comprehensive legislation on drug abuse and recovery. The search was limited to publications in the last five years inclusive of articles before, during, and after CARA. Narrowing down the years to the most recent five, provided a solid timeframe to research what has been done and what is still needed to close the gap in public policies surrounding the opioid epidemic. After applying the inclusion and exclusion criteria, more than a hundred articles remained for review. The methodology used provided an opportunity to explore what policies exists, the measurement of success based on lowered overdose rates or lack thereof, and identify the gap in public policies that is needed to end the opioid epidemic in both advantaged and disadvantaged socioeconomic environments. 5 Literature Review Prescription Drug Monitoring O’Donnell and Chu (2018-a) discuss how chronic pain patients and the groups that represent them state that the escalating government response to opioid addiction ignores their need for the painkillers and doctors who will prescribe them, leaving some out of work, bedridden and even suicidal. Hearing that patients are becoming suicidal due to an inability to get their medication because of control measures for those who may become addicted almost seems like a double sword. Opioids can be both life changing and life threatening to those who genuinely need it as a treatment for pain, while destroying the lives of those who become addicted. Chu and O’Donnell include a commentary that even though state laws say that chronic pain patients who need medication will receive it. “That’s not what’s happening,” says Lauren Deluca of Worcester, Massachusetts, who founded the Chronic Illness Advocacy & Awareness Group last year after her own challenges getting the opioid painkillers she needed (2018-b). There seems to be challenges no matter how one looks at it, and maybe because the impact is on such a large population it is not easily solved. Instead of being black and white, the opioid epidemic seems to be overshadowed by more gray areas, which adds to the complexity of the epidemic overall. So, this prompted me to fast forward a bit to see how the epidemic is being addressed from a public policy perspective, and more so to see if any progress has been made on a national level. Most recently, CMS announced that beginning on January 1, 2020, the expansion of Medicare coverage will now include opioid treatment programs that will focus on the delivery of medication-assisted treatment and counseling to individuals suffering from opioid use disorder (2019-c). While it is too premature to assess the pros and cons of this change in public policy, it appears to be a proactive approach in providing benefits and resources to those who may need 6 more hands-on guidance. It will be interesting to analyze long term if this is indeed a viable solution to reducing abuse and possibly reducing overdose rates. With that being said, it made sense to go a little further back in time to review other public policies that pre-date the CMS update. One of the most highly publicized and debatable policies in the current decade has been the Affordable Care Act (ACA). Andrews (2018-a) explains that prior to the ACA, there seemed to be far fewer patient service benefits for drug addiction treatment, and 2010 was the pivotal point when the ACA really expanded Medicaid coverage to include addiction treatment. Reading this eludes to the prior attention that was placed on limiting opioid prescriptions more so than providing access to resources that prevent or treat addiction, which can be problematic. Pitt (2018) argues that policies focused on services for addicted people improves the population without harming any groups. However, policies which reduce the supply of opioid prescriptions may result in an increase of heroin use, reducing quality of life in the short term, but in the long term could generate positive health benefits. A portfolio of interventions will be needed for eventual mitigation. In other words, services for those addicted are not considered harmful. Interestingly, eliminating or limiting opioid prescriptions could create dependency on alternatives that may prove far more harmful. It could potentially mean trading one addiction for another. Many contributing factors may include but are not limited to; length of time using the prescriptions, dosage amounts, history of addiction, pain tolerance, and maybe stress levels too. However, this is a lot more complex than one would typically think, and most probably varies from one individual to the next. The National Association of Chain Drug Stores (NACDS) formally announced support for four new public policy proposals intended to build on existing collaborative efforts to address 7 the opioid abuse epidemic while providing quality patient care. “The four integrated public policy strategies would further reduce the volume of unneeded and unused opioid medications entering the public domain, and reduce the chances that they fall into the wrong hands, while taking into account the needs of those most severely affected by chronic pain as a result of cancer and other serious illnesses,” said NACDS President and CEO Steven C. Anderson, IOM, CAE, in releasing the letter (2017-a). In reading this article, it sounded like this is a good balance between addressing the epidemic while at the same time providing the prescription to those who really need it. However, considering that this article was written prior to the ones previously discussed by both Andrews and Pitt, it seems that the issue still exists, prompting me to read further. In short form, the NACDS included four new public recommendations to legislate a seven-day supply limit for initial opioid prescriptions issued for acute pain, require all prescriptions be issued electronically with limited exceptions, create a national prescription drug monitoring program , and provide manufacturer-funded mail-back envelopes for unused opioid drugs, available to patients at pharmacies upon request (2017-b). These recommendations are more geared toward monitoring the pharmaceutical companies to ensure that prescriptions are distributed in moderation. The question then becomes: is the overuse of opioid drugs related to the lack of regulation by pharmaceutical companies or physicians, or could it be a combination of both? Depending on who one asks, the response may vary and may be controversial to a certain extent because it is a fully loaded question that redirects the issue to be more so that of the forces behind the prescription rather than the consumer. However, despite the red flags it raises behind the scenes, it is all relevant and worth exploring, especially if it can save someone from overdosing. 8 Physician Regulation In researching physician regulation, there are many interesting articles that imply how the opioid epidemic is far from being resolved. Cookson (2018-a) argues that state medical boards failed in their mission to license and discipline physicians. In a country that retains huge respect for the medical profession and has a largely private healthcare system in which doctors retain considerable individual freedom in the way they practice, most opioid over-prescribers operated with impunity. He explains that when the federal authorities belatedly raided one Williamson clinic in late 2009, they found that an individual doctor had written 355,132 opioid prescriptions over the previous seven years — about 1,000 for every inhabitant of the town. Another wrote 118,443 scripts over the same period, most of which were handed out for cash fees without the doctors bothering to see their patients. The investigators estimated that the clinic took in $4.6 million in cash during 2009 and they found banknotes stuffed into safes and cupboards in the doctors' homes and offices. Although few other places demonstrated the grotesque excesses of Williamson, similar scenes of opioid overprescribing played out across the US, as doctors, pharmacists, distributors, and manufacturers profited from human misery. The drugs were designed to kill pain, but people quickly realized that they could be abused to give a short lived euphoric high like that from heroin or opium (Cookson, 2018-b). After reading this, it began to come together as to why the National Association of Chain Drug public policies really cracked down on the physicians and pharmaceutical companies. This article enlightened me on the gains of the physicians and made me realize that the patients who become addicted are not solely to blame. This was surprising initially because often the blame of addiction is placed more on the consumer than the providing source. Since the source consists of two entities, the physicians and 9 the pharmaceutical companies, there is a need to explore in more depth how public policies are addressing the opioid epidemic in the pharmaceutical industry. Medicare and Medicaid In an article published by State News Services, the National Association of Chain Drug Stores (NACDS) explains how the pain management and opioid policies advanced by NACDS can help to guide the federal government’s action plan to prevent and treat opioid addiction. The article discusses how various policies for treatment of pain under Medicare and Medicaid may have contributed to the increase of opioids and impeded access to non-opioid pain treatment (NACDS, 2019-a). This is problematic because Medicare and Medicaid should not be tied to contributing to the increase of the opioid epidemic. The public relies on such entities to address the epidemic and bring structure through public policy to eliminate or alleviate the issue, not be a part of it. How could things shift so drastically? The NACDS also outlined how the lack of rigorous policies may have contributed to the increase in numbers of addiction and limited alternatives to opioids. The NACDS addresses the concerns of the Centers of Medicare and Medicaid Services (CMS) over the roles that pharmacists play in both pain management and prevention of opioid abuse (NACDS, 2019-b). To what extent are the physicians, pharmaceutical companies, CMS, and other entities responsible for public policy to blame? Does it really come down to the rigor of the policy itself, should there be penalties or greater consequences for all involved, and what next are some of the many questions that came to mind after reading the article. The NACDS President and CEO Steven C. Anderson, IOM, CAE states, “NACS and our members wholeheartedly agree that pharmacists have a critical role to play in curbing prescription opioid misuse and abuse by providing individuals struggling with a Substance Use Disorder (SUD), with convenient options for receiving Medication Assistance Treatment (MAT) 10 services. As the face of neighborhood healthcare, pharmacists are trusted healthcare professionals who regularly interact with patients to provide expert advice on proper medication use and deliver a growing number of important healthcare services to the public” (2019-c). This seems like a good idea and cannot hurt, but more so help the epidemic. It definitely points out that in addition to the need of more rigorous policies for Medicare and Medicaid, there is also room for pharmaceutical companies to establish more solid protocols for filling opioid prescriptions and educating the patient on the proper use to avoid both misuse and overuse. Overdose Deaths Nationally, there is an increase in deaths associated with opioid overdose. One study by Walker (2018-a) examines the medical, legal, and socioeconomic problems underlying the ongoing opioid epidemic in the U.S. with an emphasis on finding effective policy solutions. According to Walker (2018-b), in the medical system, a lack of oversight of pharmaceutical companies, deceptive marketing practices used by pharmaceutical companies targeting doctors, a massive increase in opioid production and sales, and the industrialization and automation of the medical profession are all major factors that contribute to the epidemic. Included in the study is a graph quoted from the National Institute on Drug Abuse, which outlines the increase in the number of deaths involving opioid drugs over the years between 2002-2015. Although I would have liked to see data for the last three years, this still helped in seeing the overall picture as an added secondary analysis for my own case study that I am proposing. 11 Figure 1. National Institute on Drug Abuse. This figure shows the rapid increase in opioid related deaths from 2002 to 2015. From 2002 to 2015, opioid related deaths tripled from 10,000 to 35,000. Walker (2018-c) suggests that adopting a less punitive stance towards the epidemic, and instead addressing it as a public health problem would help curtail the ever-increasing death toll and bring an end to the epidemic. This seems to be a reasonable approach. Although there has been some deceitfulness on behalf of the physicians prescribing the medications, the bottom line is that it is impacting the public’s health so that should be the focus. So, here is a methodology for a sound case study that focuses on the public. The phenomenon is two-fold: Is the lack of public policies failing to address the increased rates of addiction? In other words, does X cause Y? X represents public policies and Y represents the increased rate of opioid 12 addictions. This will help to determine whether there is a need for more adequate well-defined policies to address the opioid epidemic, to decrease the population that is suffering from addition. I propose putting patients through a classical experiment by asking the question: how many patients are prescribed opioids for pain management not related to chronic illnesses and how many of those patients suffer from addiction or overdose over time? Does X cause Y? X is the number of patients prescribed opioids and if it causes Y, which is addiction or overdose. To expand, it may be a good idea to put the patient through a classic experiment that would include pretests and posttests to be compared consecutively over a year time span but measured every three months. The classic design is where X designates the independent variable; O1, O2, O3, and O4, the measurements on the dependent variable; R, the random assignment of subjects to the experimental group and the control group; and, the difference between the posttest and the pretest in each group. The random assignment (R) is to pull patient records of both patients with chronic diseases and patients without chronic diseases. The experimental treatment (X) is to have all patients stay at a drug rehabilitation facility to see if medication is stopped and alternatives are given if the patients have withdrawals or show signs of addiction, both chronic disease patients and non-chronic disease patients. The pre-test would consist of prescribing the opioid to both groups O1 chronic disease patients and O2 non chronic disease patients. After three months, the drug rehabilitation facility would then conduct a post-test on O3 (formally known as O1 in the pretest group) and O4 (formally known as O2 in the pre-test group). The same test would be repeated and compared over time to see if prolonged use makes a difference in addiction. Based on the survey outcomes, one may conclude by saying whether or not patients who suffer from chronic illnesses are not being affected, and therefore addiction and overdose are related to patients being overtreated for 13 temporary pain management, or that opioids are addictive to patients in general and non-addictive alternatives are needed. There are various ways to address the opioid epidemic, but ultimately addressing it through public policy is ideal to get the attention needed at a national level. The Centers for Medicare and Medicaid Services (CMS) have required states that offer Medicaid programs to participate in both quantitative and nonquantitative programs to aide in the implementation of parity regulations, specifically in the Medicaid programs. In 2016, CMS required eleven states to compare quantitative (annual service limits and copayments) and nonquantitative (preauthorization and concurrent review) limits on addiction treatment benefits with those placed on other medical services and to address compliance deficiencies. As a result, states must monitor their compliance with parity regulations and submit reports to CMS (Andrews, 2018-b). This demonstrates that regulations are moving toward consistency by fairly evaluating addiction treatment in comparison to any other medical treatment. However, at the crux of the epidemic is why Medicaid is linked to high numbers of opioid abuse. Socioeconomic Impact Medicaid beneficiaries are typically classified as being part of a group that is unemployed, low income, and often uneducated. This prompted me to question if Medicaid limitations are doing a disservice to low-income Americans. However, those socioeconomically disadvantaged are not limited solely to Medicaid beneficiaries. Therefore, if any disservice is being done, it is not specifically because of Medicaid limitations alone. Dasgupta (2018) highlights how being economically and socially disadvantaged is intricately linked to using opioids as an escape from psychological and physical trauma, disadvantage, hopelessness, or isolation. Romoser (2019-a) shared some insight from specialists who urged Congress to give 14 more federal money to providers on the front lines of the opioid crisis, including funding of programs that were authorized in 2018 as a major opioid bill. “We have a very big treatment gap and a huge workforce shortage that’s going to affect us now and in the future,” Yngvild Olsen, the medical director of a treatment program in Baltimore, said at a briefing on Capitol Hill. She and other panelists who spoke at the briefing said Congress can do more to encourage health professionals to work on addiction, especially in underserved regions (Romoser, 2019-b). Investigating more data driven case studies are needed to further understand the impact. In an effort to evaluate the socioeconomic predictors of drug mortality rates, particularly opioid mortality, Monnat (2019) ran multivariate and multivariable regression models to predict probabilities of membership in each “opioid mortality class” based on county level census measures. Various methods were used including, but not limited to, mortality statistics, census data, socioeconomic comparisons, and socioeconomic regression analysis based on multivariate and multivariable models. Those socioeconomically disadvantaged had more access to opioids, based on higher prescription rates. The results reflected both higher opioid overdose and mortality rates. Those in socioeconomically environments were subject to limited job opportunities that were more so factory workers rather than an office environment. However, syndemic opioid environments had a mix of both factory and office workers were highly impacted as well. Socioeconomic status impacts opioid drug use and mortality rates. Census data along with other measurement tools help to identify the counties status for comparison. The abuse rates vary from one location to another based on different factors that are unique to each area. Therefore, more public policies are needed not only at the national level, but also regionally, with an emphasis on socioeconomic advantages and disadvantages (Monnat, 2019). 15 CARA The Comprehensive Addiction and Recovery Act (CARA) is the first major federal addiction legislation and by far, the most comprehensive effort to address the opioid epidemic, according to the Community Anti-Drug Coalitions of America CADCA (n.d.-a). The legislation was introduced on February 12, 2015. However, it was not until July 22, 2016 that President Barack Obama signed CARA into law, known as Senate Bill 524. The first section of the bill requires the Department of Health and Human Services (HHS) to convene Pain Management Best Practices Inter-Agency Task Force to enforce best practices for pain management (n.d.-a). While the bill addresses six different components surrounding addiction and recovery, the first and most important is prevention and education because that could ultimately override everything else if it prevents use altogether. The CARA bill remains active today. According to CADCA (n.d.-b), the CARA Act is a federal addiction legislation to address the various aspects surrounding drug addiction and recovery, including but not limited to; prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal. The program was established to help those struggling with addiction, prevent others, and make sure that prescription drug monitoring is being enforced by physicians and pharmacists, as well as other entities (n.d.-b). This legislation was needed because in the United States there has been a rapid increase in drug addiction, and overdose rates from opioids remains relatively high. McLaughlin (2016-a) shares a report that according to NPR, the Centers for Disease Control and Prevention (CDC) reported that in 2014 an estimated 129 Americans died daily as a result of drug overdose, and specifically two-thirds of those deaths involved the use of heroin or opioids. While there have been various related bills over time, the Comprehensive Addiction and Recovery Act of 2016, also known as S-524, is the 16 most comprehensive bill focusing on addiction and recovery, which the Senate has passed. The timing seems to align with the opioid epidemic crisis. So, although it is most comprehensive to date, it may simply be based on the lack or need thereof prior due to lower death rates or unidentifiable associated deaths. The various categories that the bill focuses on makes it so comprehensive and new in the sense that there is a major focus on prevention and education, which does not seem to be part of previous legislations. Although the CARA legislation remains in effect and unchanged, Gross (2019) explains that the funding which exceeds $181 million annually must be appropriated every year. An example of this is that Senators introduced policy changes to address the opioid epidemic for both 2018 and 2019 fiscal years to increase funding, in effort to support the three day quantity limits for acute pain prescribing supported by the CDC, lower restrictions on medication-assisted treatment, and to make penalties greater for manufacturers who are contributing to the diversion of opioids. This approach reflects that the United States healthcare system is taking proactive measures by consistently evaluating public policies from an economic perspective, and reevaluating annually the effectiveness of the program by placing tighter controls on manufacturers to limit further aide in abuse. Wang (2018) highlights that in addition to funding measures, the campaign will “bring greater awareness to the association between prescription opioid misuse and heroin use, emphasize their similar effects on the human body, and educate the public about the lethality of fentanyl, which is increasingly mixed with heroin and other drugs.” Considering that this legislation is not limited to the state level, but impacts all states federally in the country, politicians supporting or opposing the legislation would most definitely have played a big role in the success of passing the legislative bill for it to become law. While there seems to be a great amount of political support for the CARA legislation, this was not 17 always the case. Rosenberg (2016) argues that ten years ago our congressional leaders lacked knowledge and the urgency as to why addiction and mental illness are to be of a concern, and as we continue to progress there is a need for the constant reminder of what matters. This conscientious push is needed to be able to move ahead. Overall, when addressing an epidemic, an understanding of what matters and what is at stake is crucial to the success of overcoming the crisis or at least having a substantially long-standing impact. The CARA bill was sponsored by Senator Sheldon Whitehouse of Rhode Island, and out of 44 current cosponsors, only five were part of the original cosponsors according to data on the Congress website (n.d.-b). So, this poses the question as to why there was a sudden shift in bipartisan support. Furthermore, how did this meeting of the minds happen so quickly, considering that the legislation was passed within eighteen months after it was presented? McLaughlin (2016-b)discusses an NPR interview that took place six months before the legislation was signed into law, surrounding the Senate judiciary committee hearings on both heroin and prescription drugs, where Democratic Senator Dick Durbin of Illinois indicated that as a result of the opioid addiction epidemic expanding from being isolated as an urban problem to one that affects country as a whole, the scope of the issue could create the political momentum needed to address it. It appears that it is not a major issue of tension or divide amongst Democrats versus Republicans as many other bills typically face, but more so seen as an issue that does not discriminate and cannot be isolated to one area or state more so than others because it is a national issue that affects both political parties and people in general. History shows that most Senate bills are met with a mix of support and opposition by various interest groups and a lot of controversy by those with opposing point of views. However, the CARA bill received a large amount of support from various stakeholders including the 18 Partnership for Drug-Free Kids, Community Anti-Drug Coalitions of America, the National Association of Attorneys General, and other organizations in the treatment and recovery communities. In fact, the Senate Judiciary Committee was able to successfully advance the bipartisan bill by voice vote with no formal opposition according to the news release by Congressional Documents and Publications (2016). While I am sure that this bill may have reduced the revenue of some manufacturers, it is refreshing to see that opposing political parties were able to agree on a bill for the sake of potentially saving lives. This is also a reflection that many Americans share a common ground when it comes to comprehensive health care. Interestingly, this legislation includes addiction and treatment services for women, families, and veterans. The CARA Act allows grants for women who are pregnant, as well as postpartum for those suffering from substance use disorder. The legislation not only addresses the population overall, but it has also carved out a section addressing pregnant women and children. While researching the impacts of addiction and recovery for pregnant women and their infants, it was surprising to see that Stephens (2019) reported that from 1999 to 2014, there was a significant increase in pregnant women diagnosed with opioid use disorders basically quadrupling, and the diagnosis in infants suffering from neonatal opioid withdrawal had matched pregnant women by double, nearly sevenfold. These numbers are surreal in a sense and may be a major factor in adult addiction rates being so high, because there could be a correlation to those children born with addiction. Possibly men are considered abusers of drug and addiction, but our society often overlooks women who suffer from addiction, particularly pregnant women. 19 CARA 2.0 Approximately eighteen months following the CARA legislation being signed into law, a bipartisan group of senators expanded the opioid legislation under CARA 2.0 on February 28, 2018. An economic investment of $1 billion for addiction treatment and recovery was added as part of the CARA 2.0 according to Wang, and there was also an increase in the civil and criminal penalties applicable to opioid manufacturers that are lacking diversion control, a requirement for prescribers to utilize state prescription drug monitoring programs (PDMPs), and authorizes both physician assistants and nurse practitioners to prescribe FDA approved medication assisted treatment (2018-a). The added components of the legislation imply more direct accountability and consequences to drug manufactures who are not fully complying with the set parameters of the original CARA legislation. There are also regulations set forth by the Attorney General as it relates to enforcing penalties for acute pain prescriptions in excess of a three-day supply as outlined in the bill. Wang (2018-b) shares detail of how the Attorney General is not obligated to register or renew the registration of practitioners who are licensed under state law to prescribe controlled substances if there is negligence in not abiding by the three-day supply limits. The harshness in this approach draws attention to the seriousness of the matter. Wang (2018-c) mentions that each state’s PDMP is required to submit quarterly deidentified data and annual reporting that is accessible to state agencies, researchers, health care providers, health plans, and health benefits administrators. So, the externality of the data is more prevalent on a national level, which enables state agencies and health benefit administrators to monitor the progress of the bill and implement change along the way to ensure the success of the bill is maintained. Data are necessary to analyze if the purpose of the legislation is effective. Wang (2018-d) details a press release from Republican bill sponsor Senator Rob Portman of 20 Ohio, highlighting that CARA 2.0 expands upon the original CARA by increasing the funding authorization levels to align with the most current budget agreements, as an essential response to the urgency for sufficient and sustainable resources that properly align with the magnitude of the crisis itself. Funding is an essential component in addressing addiction and recovery because funds will allow more facilities to open and provide compensation to healthcare workers to treat patients suffering from abuse. The data will support how the funds are best used. Economic status plays a role in addiction risk. According to Midboe et al. (2019), homeless veterans or individuals with unstable housing are at an increased risk for both high morbidity and mortality rates stemming from opioid drug use. Based on this analysis, there seems to be a socio-economic gap. Neville and Foley (2020-a) detail how costs associated with premature mortality, childcare, family assistance, lost productivity, criminal justice, and healthcare services are growing rapidly causing an economic burden. Naturally those in more poverty stricken areas or those without a stable home will be more highly impacted, as they might lack childcare to get the help needed or cannot afford to take time off from work to focus on their health. At the time of the CARA being signed into legislation, there were many economic factors impacting the public, specifically there was a need for health care reform. Many Americans were finding themselves without health care coverage. In addition, opioid death rates resulting from suicide and overdose were also on the rise. So, having the CARA expanded health care for addiction and recovery comprehensively by focusing on addiction treatment as being a health care necessity. The CARA legislation impacted the economy in a profound way because it provided resources and help to those who suffer from addiction, but also education to aide in 21 preventing addiction in an effort to save lives that were lost as a result of succumbing to drug abuse. Those who are homeless may not know about resources to help with addiction. Health care coverage and access to care may be limited. According to Zevin and Lum (2019), opioid overdose is one of the leading causes of death for the homeless population and substance abuse disorders among them are much higher than that of the general public. They continue, by explaining that while buprenorphine is a recommended treatment for opioid use disorder amongst people experiencing homelessness, they are faced with other challenges like social isolation, competing priorities, as well as barriers to care and discrimination. Isolation may result from self-esteem issues, which may have an impact if the individual is afraid that they will have to provide a home address when reaching out for public assistance. Competing priorities may be present in the sense that there may be an issue of where to sleep or where is the next meal coming from rather than how does one get help with addiction, so the priority level of addiction assistance may rank relatively low based on other concerns. Also, discrimination may be deemed a barrier because users may be subject to being stereotyped. In addition to the homeless population, others who are socioeconomically disadvantaged such as those with low income are highly impacted by substance abuse, particularly women with low paying jobs. Kissin et al. (2015-a) completed a case study on how employment challenges are a factor for low-income substance abuse among women. The CARA allows grants for women who are pregnant, as well as postpartum for those suffering from substance use disorder. The legislation not only addresses the population overall, but it has also carved out a section addressing pregnant women and children. So, there are strong implications that women will get the attention and care needed to battle addiction that is aligned more similarly to the support that 22 men receive. Kissin and colleagues (2015-b) discuss how women have greater risk of mental health concerns and employment health barriers. While society has come a long way in recognizing women equality, the perception still remains that women are at a disadvantage in many categories. Considering that the CARA bill carved out a section for women is a big stance in addressing the socio-economic disparity for addiction and recovery based on gender. The Role of Public Policy Gross and Gordon (2019-a) point out that although legislative efforts are apparent in addressing opioid use causing a reduction in prescriptions, there is still a significant rise in suicides and overdose deaths, which is an indication that there is a policy imbalance between strong prescription controls in comparison to weak pain and mental health treatment. The CARA legislation was passed in 2016 and was enhanced in 2018. However, in 2019, there was still a rise in deaths associated with opioid use. There is a sense of pressure and responsibility on health and public administrators to create more effective policies that will confer a positive impact on health overall. To really combat the opioid epidemic there must be sufficient facilities available nationwide to treat drug abuse. The CARA legislation does provide funding for recovery, but how treatment facilities utilize the funding may vary. If the funds are used more for luxury amenities than recovery efforts, the supply for those seeking full recovery may be inefficient. Edlin’s article (2018) highlights commentary from Lisa Blanchard who is the vice president of clinical services for Spectrum Health Systems: she states that while rehabilitation and recovery facilities may offer luxurious amenities in a desired location, they are often lacking the necessary clinical care. So, maybe public administrators and legislative parties should push for an increase in supply (i.e. more facilities), but driven by the core values and possibly measure the patient 23 outcome by surveying those who receive treatment to see if they become and stay clean after rehabilitation treatment. Overall, CARA is aimed at reducing substance abuse and helping former abusers in their journey to sustained recovery. The need for broader awareness and education surrounding addiction is much needed, based on the rising of deaths related to drug abuse. This legislation was a grave need when it was signed into law in 2016 and broadened in scope in 2018, as it is currently the main legislative action that still remains today on the United States agenda to nationally combat the opioid epidemic , as many people suffer and lose their lives succumbing to addiction. A reduction in deaths would be an indication that the policies being implemented are serving their intended purpose. Gross and Gordon (2019-b) explain that one of the biggest challenges with creating and implementing policies is the uncertainty of the impact and farfetched implications that may not have been considered or intended at the time of creation. This has some substance to it, considering that economic factors surrounding the health care system is constantly evolving and therefore the solutions cannot become stagnant. So, what was implemented years ago may remain a solution. Nevertheless, it may need some refinement and more relevant and concise policies to reinforce the original intent. Considering that lives are being lost, a more proactive approach may be warranted, as a standalone public policy may not be enough to remedy the epidemic and close the margins of suicide and overdose resulting from addiction and substance abuse and addiction. The CARA and CARA 2.0 are much needed legislation that have the potential to impact the health care system in various positive ways. However, health and public administrators will need to continue to monitor the effects over time to measure if the impact is significant enough to end the epidemic. Gross and Gordon (2019-c) provided the analogy that pain management is a 24 serious public health problem that needs public policy at both the national and local levels to resolve incidents of insufficient, ineffective, and disparate pain treatment while limiting the risk of inadvertently increasing the use of treatment such as opioids that can result in public harm. If hospitals adopt the policy in the background of their everyday operations by proactively limiting and monitoring opioid medications that are more likely to be addictive, it will help reinforce the intent of the CARA legislation. However, it will take a group effort by health care professionals and public administrators nationally to really make a difference. Neville and Foley (2020-b) outline how integral the role of nurses as frontline providers are and essentially how nurses are now being given more control in a call to action to also help join the fight in the opioid epidemic through the provision of comprehensive, cost-effective, and multiple levels of humanistic provision, including but not limited to primary, secondary, and tertiary care. Legislations like CARA are enabling a more prominent role for nurses to provide care and make a difference. Considering that addiction is broad in terms of types of addiction and the direct impact may also vary based on abuse levels, it makes sense that health care providers at all levels join forces to help reduce the amount of cases. Politicians and Health Care Professionals Politicians must continue to present a united front in terms of how they view addiction, and the attention required to have a solid resolution. Similar to how both parties came together to sign the bill into law, they will need to maintain a common understanding that addiction does not discriminate or target a specific political party. It is a disease that has no boundaries. Thinking in terms of the future of our country, the best way to approach the epidemic is for political parties to be passionate and have the state of mind that a call to action is needed, because the risk of it hitting close to home is likely. Politicians represent the beliefs of people with varying views and 25 from all different backgrounds, class, race, gender, as well as financial status. Understanding that socioeconomic status is a factor in addiction, providing more funding to those who are disadvantaged is essential. The CARA legislation was an initiative of the sitting president at the time, and it may take the political backing of another president to really fulfil the intended purpose. When lives are being lost, there is a clear indication that this is a battle that cannot be fought alone. It will take politicians, health care workers, public administrators, and the support of family and community. Health care workers and public administrators must take their roles seriously and think of it as a call to action not just a job. Recognizing addiction as a medical condition that can be treated and prevented is the primary purpose of the CARA Act, which has significantly impacted our economy in a positive way by providing assistance to all including the homeless and women, as well as pregnant women. It is a shift in our culture as American healthcare workers and has further defined the role and responsibility of drug manufactures. By enhancing the CARA legislation, more funding and resources are being provided to advance the cause. If there is a continuance of improving the socio-economic gap for those suffering from addiction and recovery, as public administrators we will be able to reach a broader audience and control the opioid epidemic. Based on the impact and expansion of resources within the four years of signing the CARA bill into law, strides are being made and most importantly awareness is leading to a proactive support system that will ultimately eliminate economic barriers, thus reducing suicide and overdose deaths related to addiction. 26 Policy Implications It is evident that existing public policies are not successfully addressing the opioid epidemic. Through my literature review I have concluded that the policies centered on drug abuse are not serving their purpose. While the CARA policy is the most current comprehensive of all those reviewed, in the four years of existence it has not proven to be robust enough to overturn the opioid epidemic and prevent the high death rates associated with drug overdose. The policy is broad in covering prevention, treatment, recovery, and overdose reversal. However, it fails to distinguish opioid addiction as a health disease that can be controlled and contained. Preventing one person from using drugs, potentially can save many others that would be exposed by their influence. Although an epidemic, the opioid crisis needs the same health attention as a major pandemic such as the Spanish Flu or the Coronavirus known as COVID-19. In the sense that it will take a nationwide effort to control it, and the sense of urgency that if not addressed quickly more lives will be lost. In our current day, every news channel gives updates on COVID19 and restrictions for the public are highly governed daily by each state governor and the president routinely provides briefings. If the same type of attention were given to the opioid epidemic, we would make some progress because essentially our political leaders would be directly influencing the population. We need all politicians to address the opioid epidemic and conversations need to be ongoing. There should be an apparent proactive influence and it should be at the top of the news making it an urgent topic of discussion. Programs and policies that are relevant to the abuser must be in place to end addiction and restrictions must be placed where possible to gain control. I suggest that the CARA policy have an addendum that is specifically geared toward influence. The addendum would outline the actions required by politicians, health care professionals, and 27 law enforcement to actively engage those suffering or struggling with addiction. In effort for the policy to have an influence it must actively be in force and those in positions to influence change must be proactive, not reactive. Reversing overdose is reactive and comes with the risk of death should the reversal be unsuccessful. Therefore, having public policies that are created for reference, but are not actively being applied, lack influence and fail to address the crisis. Adding an active addendum to the policy that is reviewed and updated annually, will aide in closing the gap. The aggressiveness of the revisions would be measured against the overdose and addiction rates. The addendum coupled with political intervention will help to combat the crisis. Classifying opioid addiction as a health condition will give it a sense of urgency. Health care coverage should be more comprehensive in providing access to care for those struggling with addiction and follow up should be an essential responsibility of health care providers who have treated patients suffering from addiction. In my literature review, there was also evidence to support the notion that those socio-economically disadvantaged are more likely to succumb to addiction. Therefore, an essential component of the public policy should be inclusive of limits on associated costs for health care needs for those suffering from addiction. No one should go untreated as a result of lack of affordability for both prevention and treatment. Lastly, I propose opioid prevention education become an ongoing requirement for teens and young adults as early as middle school through college years. If opioid addiction is fully classified as a health condition, then it opens the opportunity for drug prevention to be inclusive to health science education. Having a public policy incorporated as a requirement in school curriculum nationwide, will not only bring awareness to students, but also enable them to make informed decisions resulting in positive choices against substance abuse. 28 Conclusion To better control the high mortality rates stemming from opioid addiction, physicians and pharmaceutical companies should not be penalized. Rather, there should be public policies in place that address the opioid epidemic as a public health condition. The outcome would be more influential, because of the level of urgency associated with this reclassification. As a result of data based on quantitative and nonquantitative case studies conducted by CMS, there are now parameters in place to monitor compliance through routine reporting. Interestingly, the opioid addiction rates are much higher amongst the Medicaid population. Based on multivariate and multivariable regression models there seems to be a correlation between socio-economic status and addiction. Socioeconomic status plays a major role in addiction putting those who are disadvantaged more at risk. Medicaid patients are often underprivileged, earning little to no income. Proactive measures in neighborhoods that are poor and unemployed can potentially reduce drug overdose that often stems from drug abuse prompted by depression, stress, and financial struggles. I conclude that existing public policies are failing to address the opioid epidemic, which is evident based on a 44% increase in reported drug overdose mortality rates. To successfully close the gap and end the opioid epidemic, more rigorous public policies are needed that are aimed at influencing society and calling a sense of urgency to opioid addiction as a health condition that can be controlled. 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