AQ31-Proposed Rule-Elimination of Copayment for Opioid Antagonists and Education on Use of Opioid Antagonists
2020-11-18 2020-11-17 2020-11-12 2020-11-09 2020-11-09 2020-11-09 2020-11-18 2020-11-19 2020-11-18 2020-12-10
VA-2020-VHA-0023-0009 VA-2020-VHA-0023-0008 VA-2020-VHA-0023-0006 VA-2020-VHA-0023-0003 VA-2020-VHA-0023-0004 VA-2020-VHA-0023-0005 VA-2020-VHA-0023-0013 VA-2020-VHA-0023-0015 VA-2020-VHA-0023-0010 VA-2020-VHA-0023-0019
05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00 05:00:00
https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0009 https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0008 https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0006 https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0003 https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0004 https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0005 https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0013 https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0015 https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0010 https://api.regulations.gov/v4/comments/VA-2020-VHA-0023-0019
Kaitlyn Kyle Casey Anonymous Eugenia Suzanne Patricia Evdokyia Fatima Cade
Eckley Caldwell Capstick Anonymous Cabrera Kleisch Thomas Hail Akbar Myers
Opioid addiction is an ever-present threat to individuals living in the United States of American and around the world. According to the National Institute on Drug Abuse, 128 Americans die each day from a drug overdose. The problem of opioid addiction and overdose has been an increasingly important issue in the United States over the past couple of decades. Public health professionals and governmental organizations have been working together to create initiatives and rulings that favor preventative and treatment services for individuals that are addicted to drugs. The problem of opioid dependence is one that was, in part, caused by the drug manufacturers and physicians of the 1990s. Addiction and overdose are problems that need to be addressed. The United States Department of Veterans Affairs is working to improve the health outcomes of veterans who are at risk for addiction and overdose due to opioids.Many deaths related to opioid addiction are preventable with public health intervention. Drug addiction is a multifactorial health issue caused by a multitude of different situations. Individuals impacted by opioid addiction often lack sufficient social support systems, suffered previous serious injuries, and are victims of poor prescription practices. Without interventional activities, an addicted individual could end up dying from a drug overdose. There are currently several populations disproportionately impacted by opioid dependence and opioid overdose.Several populations are more vulnerable to struggling with drug addiction. A specific population at an increased risk within the United States are veterans. The Department of Veterans Affairs has an entire unit dedicated to overcoming drug abuse in veterans. The organization states that veterans experience Post-Traumatic Stress Disorder (PTSD) as a result of their service to their country. These individuals are more susceptible to drug use. This increased use could pose threats to their lives. Additionally, as a person is exposed to more stressors, the more that negatively impacts their health outcome.Opioids are powerful drugs. Many of them serve as integral aspects of pain-relieving treatment in the United States. However, there are drawbacks to these powerful compounds. According to the Centers for Disease Control and Prevention, in the 1990s, the number of prescriptions written out for opioids began to rise. A rise in prescriptive practices correlated with the increased mortality due to opioid overdose. Since the discovery of opioids as an effective treatment for pain management, there have been issues with abuse, addiction, and overdose. As a nation, the United States is currently trying to combat this public health crisis.A rule recently proposed by the Department of Veterans Affairs dealt with opioid addiction in the veteran population. As previously noted, these individuals are at an increased risk of addiction and overdose with opioids. The proposed rule would eliminate copay requirements for veterans seeking help for opioid addiction. Additionally, copayments would not be required for the obtainment of opioid antagonists. Common opioid antagonists are Naltrexone and Naloxone. Drugs like Naltrexone and Naloxone act in opposition to opioids. Opioid antagonists allow for the reversal of the negative impacts of opioids. If using extended-release versions of these drugs, they can cost hundreds to thousands of dollars. Veterans are typically older Americans who are already on restricted incomes. Adding this expense could push their budgets to the max. Eliminating the copay for Naltrexone and Naloxone could not only reduce the cost burden for veterans but also save their lives.The number one cause of opioid dependence is related to pain management. Veterans experience injuries that persist well after they return home. We must ensure they have access to all of the services that they need to live a happy and healthy life. These high-risk individuals should have adequate access to opioid antagonists. Veterans should also have access to counseling and educational information on the subject of opioid addiction. We must fight for those who fought for us! Opioid overdose death rates in the veteran population have increased over 65% since 20101 which is of particular concern after noting the already increased risk veterans are placed at for developing comorbid mental health conditions. The Department of Veteran Affairs has many initiatives in place for combatting this problem, but there remains the issue of opioid use specifically as research is continuing to show that current efforts (such as decreasing prescription provision) are not sufficient in reducing this phenomenon. This proposed rule would eliminate the copays needed for veterans covered under the VA to access potentially life-saving drugs such as naloxone, an opioid antagonist that could bring an individual out of an active overdose. While available without prescription, naloxone can cost individuals hundreds of dollars without insurance in some locations, and even with insurance can be costly. Previous research in the veteran population has shown that increased copays can decrease not only medication adherence, but medication seeking2. If the goal is to protect our veterans from the harm of prescription drug misuse, the answer shouldnt be making it more difficult to access ALL medications, but instead making those that are helpful and potentially life-saving more accessible. The military experience, as researchers have described it, puts veterans at a unique risk for developing mental health conditions that adversely affect their daily life and can drive other inhibiting factors such as homelessness or poverty3. The logical and data-based solution that exists to help prevent these factors from interfering with an individuals ability to access necessary healthcare is to eliminate copays when capable3,4. We see that the opioid epidemic is showing no signs of slowing down and we know that since 2017 there have been staggering trends in overdose fatalities even without considering veteran status. Adding this in, it seems only logical that this step, eliminating copays for opioid education resources and antagonist agents, be taken to protect those that spent their life protecting us. This proposed rule does, however, indicate that these waivers would be applicable to those indicated as high risk and does not have current definition about how those identifications would be made, which is where I think there should be further discussion. Previous research has discussed the different conditions that are unique to veterans regarding opioid use as well as how veterans are at a higher risk level than many for disabling conditions upon returning from service3. This prompts me to question the necessity of this inclusion for this proposed rule. Why must an already-established high-risk individual be re-classified into a second tier of high-risk to access resources that should be available to all? What separates risk level when you are involving an already high-risk group of people? Why do we need to sever the resources within this population? Arent all at a high enough risk to justify their deserving free resources to protect their health? This proposition also includes leverage about education. I think this is an extremely valuable consideration and am so glad to see that the VA is wanting to educate those at risk of opioid misuse on ways to prevent overdose as well as how to respond in the event that those efforts arent successful. That said, why are these services not currently being provided, and if they are to be in the future, why is a copay even necessary? What message does that send our veterans? This proposed rule about eliminating copay requirements for opioid antagonists and educational services about their use is extremely encouraging and a giant leap forward in my view. What I want to focus on moving forward is why we are still considering only providing this accessibility to some, and not to all. Is it necessary to classify at-risk individuals by who has the most risk, when in reality they all are in need of help? Is it really that much of a stretch to provide this service to all veterans? Can we not work together for all and not just for some?1.https://doi.org/10.1016/j.amepre.2019.01.0162.https://doi.org/10.1161/circulationaha.108.783944 3.https://doi.org/10.3109/10826084.2013.796991 4.https://doi.org/10.1161/circulationaha.108.829655 The Opioid Crisis in the United State is getting worse every day. Studies show that individuals with mental health illnesses have a higher chance of developing comorbid conditions like substance use disorders.  Risk factors for mental health illnesses consist of both stress and trauma (NIH Comorbidity: Substance Use Disorders and Other Mental Illnesses DrugFacts) that are commonly found in the Military experience. The 2014 JAMA Psychiatry study found the rate of PTSD to be 15 times higher than civilians. (NAMI Veterans and Active Duty)  Given this information, it is the duty of the Department of Veteran Affairs to eliminate copays for Opioid Antagonists and Education on Use of Opioid Antagonists free of cost The elimination of copayment for opioid antagonist is critical for the progress in the United States. More specifically it is needed to prevent overdose among veterans and people affiliated with the Dept. of Veteran Affairs. Eliminating the copayment for opioid education will benefit people of all backgrounds but especially for people who may not have the funds to educate themselves on the dangers of opioid abuse. Proving the free education will prevent future overdoses and also spread awareness of the negative side effects of drug abuse. I would change the wording in the proposal from antagonist to something that is more relatable and not so demeaning to people who will interpret it the wrong way. Other than that, the proposed federal rule should be passed and will be very beneficial to society as a whole.  Medical protocols that govern copayments to correspond with current legislative requirements. VA would be eradicating the copayment prerequisite for opioid antagonists equipped to veterans. These veterans who are at abnormal risk of overdose of a explicit medication or substance in order to setback the result of such an overdose. VA would also explain that no copayment would be mandatory for providing of learning on the use of opioid antagonists. The recommended rule would be a crucial part of VAs challenges to help veterans at an extreme risk of overdose. While Public Law 114-198, sec. 915 and Public Law 114-223, sec. 243 already have eliminated co-payments for Veterans regarding Opioid antagonists, and the education of utilizing those lifesaving antagonists this rule would make the law clear in the VAs co-payment regulations, 38 CFR 17.108 and 17.110. This measure is critical in creating cross-governmental cohesion in the fight against the opioid crisis in our Veteran populace. According to the Veterans Administration, the use of Opioids by the VA has decreased sustainably in the past several years, which has led to a decline in Opioid use and addiction amongst our Veterans. The availability and education on the use of Opioid antagonists would only further this fight against addiction and potentially save the lives of those suffering from Substance Abuse Disorder.  The amendment to Section 17.110 paragraph (c)(12) adding a clear definition to whom is characterized by high risk is also an essential step in ensuring that any Veteran needing these measures will have the availability of lifesaving opioid antagonists afforded to them.This proposed rule to amend 38 CFR 17.108 and 17.110 only solidifies the message of a united front against the opioid crisis in our Veteran community, and it secures that the policies enacted by Public Law 114-198, sec. 915 and Public Law 114-223, sec. 243 remain intact.  The U.S. Department of Veterans Affairs (VA) proposal for this rule change is a great idea to remove the barriers to treatment faced by veterans. Removing copays and providing education are two strategies that could potentially improve the health outcomes of veterans battling opioid use disorder (OUD) which leads to opioid overdoses. We must combat the factors that may deter veterans from receiving treatment. This proposed rule to, provide education on the use of opioid antagonists and to exempt co-payments, showcases the VA understands the need for prevention intervention strategies to remove the burden on the veteran population and their families. According to the Pain Management Opioid Safety VA Educational Guide (2014), veterans are more likely to die from accidental overdose than non-veterans.1 Research shows that veterans are prescribed higher doses of opioids and receive prescriptions for sedatives concurrently when suffering from Posttraumatic Stress Disorder (PTSD).1 This combination increases the likelihood for an accidental overdose.1 The National Institute on Drug Abuse found that barriers to opioid antagonist include stigma, lack of education, and lack of patient interest.2 Other research found that logistics, treatment experiences and beliefs, and knowledge of OUD medications also contribute to the lack of opioid antagonist use by patients and providers.3 The stigmas associated with OUD and high out-of-pocket cost were the most common barriers for patients.3 A common drug to reverse the effects of opioid intoxication is naloxone, commonly known as Narcan. In 2013, the Substance Abuse and Mental Health Services Administration started to recommend providers prescribe this drug to patients taking opioids.4 The cost of Naloxone product have been increasing since 2009. Currently the version manufactured by Kaleo has increased from $690.00 USD in 2014 to $4,500 USD in 2016.4 This life saving drug can cost a veteran hundreds of dollars with insurance and be even more costly without it. The goal should be to improve the health outcomes of all veterans. Making sure they can afford their medications is one way to do this. Removing the co-payments from inpatient hospital care, outpatient medical care, and for medications will remove the barrier veterans face when trying to receive care. A large majority of veterans deal with homelessness and poverty after service. It is understandable that these veterans will not have insurance that will cover these treatments. The lack of knowledge about OUD medications contributes to the absence of opioid antagonist use by patients and providers. Research found that the lack of knowledge pertained to where/how to get treatment and negative views of OUD medications.3 Providing education will give veterans a sense of involvement and control over their treatment. Educating on the use of opioid antagonists to reverse the effects of overdoses of specific medications or substances will improve the health literacy of veterans. With the epidemic on opioid overdose continuing to rise it is important that we create legislation to combat it for the most at risk populations. Veterans volunteer their lives and time to protect the United States and it is our duty to protect them when they return home. Many veterans suffer from injuries, both physical and mental, while in service to this country, that lead to their prescription and addiction to opioids. They come back from war and suffer from stress, anxiety, pain, trauma, which tarnishes their mental health. The proposed rule by the VA to eliminate co- payments for inpatient hospital care, outpatient medical care, and for medications and providing education on opioid antagonists gives us the opportunity to do just this. As a daughter to two veterans and a family member to multiple veterans from varies branches of the military I believe this proposed rule will be impactful to veterans battling OUD.References1.Pain Management Opioid Safety VA Educational Guide . U.S. Department of Veteran Affairs ; 2014. 2.NIDA. Substance Use and Military Life DrugFacts. National Institute on Drug Abuse website. https://www.drugabuse.gov/publications/drugfacts/substance-use-military-life. October 23, 2019 Accessed November 18, 2020.3.Mackey K, Veazie S, Anderson J, Bourne D, Peterson K. Evidence Brief: Barriers and Facilitators to Use of Medications for Opioid Use Disorder. U.S. Department of Veterans Affairs ; 2019. 4.Gupta R, Shah ND, Ross JS. The Rising Price of Naloxone  Risks to Efforts to Stem Overdose Deaths. New England Journal of Medicine. 2016;375(23):2213-2215. doi:10.1056/nejmp1609578  Comment on Government Agency Document with Request for Public CommentThe Department of Veteran Affairs (VA) proposes a rule amending medical regulations to eliminate the copayment requirement for opioid antagonists furnished to veterans at high risk of overdose. The purpose of this rule is to help veterans at high risk of overdose by eliminating barriers to this medication. High risk of overdose is defined by provider diagnosis of either current opioid dependence or treatment as well as a history of prescription drug or other substance misuse. Elimination of this copayment is an important step in protecting veteran patients with a risk of opioid overdose. Opioid overdose is a well known blight in our society. Opioid prescriptions have long played a role in long-term treatment of patients with chronic and severe pain. While more and more literature shows the downsides of this prescription practice and CDC guidelines work to stem opioid prescriptions, the healthcare system is nonetheless forced to attend to the amount of patients currently reliant of opioid prescriptions and their associated health risks. A multi-faceted approach attending to long-term pain management solutions and short-term patient safety concerns is necessary. One of the short-term needs for patient safety is protection against opioid overdose. According to the CDC, 47,600 people in the U.S. died as a result of drug overdoses involving opioids in 2017. While overdose-related deaths decreased 4% from 2017 to 2018 (CDC, 2018), the problem is not going away anytime soon. Naloxone is an over-dose reversing drug available by prescription for patients at high risk for opioid overdose. This medication is an acute response to a patient immediately after overdose and accessibility is indispensable. Essentially, this medication only works if it is readily available when an overdose occurs (CDC, 2019). Trends in naloxone prescription as studied by the CDC show that while prescription rates have increased from 2012 to 2018, there are significant differences in dispensing naloxone between states and counties despite consistent state and national laws. Studies show that nationwide, only one naloxone prescription is dispensed for every 70 high-dose opioid prescription (ie. High risk patients for opioid overdose). Also a significant amount (71%) of Naloxone Medicare prescriptions require a copay, compared with commercial insurance. From these studies, we can see the barriers to access that must be overcome in order to provide safety measures to patients at high-risk to opioid overdose. So how do veterans fit into this picture? Veterans are a high-risk population for both opioid use and abuse. According to the October 2018 statement from Robert Wilkie, Secretary of Veterans Affairs, veterans are 40% more likely to experience severe pain than non-veterans while nearly 50% of older veterans carry some form of chronic pain diagnosis. Moreover, veterans are twice as likely as non-veterans to die of opioid-related drug overdose. Pain recovery and risk of opioid addiction are complicated by co-occuring mental health disorders such as anxiety, depression, and post-traumatic stress disorder (Henson, 2020). These factors all set up a picture where veterans should have extra protection and access to safety measures such as Naloxone.Therefore, the Department of Veteran Affairs decision to eliminate the copay for opioid-reversal agents, such as Naloxone, is a hugely important step in supporting veterans at high-risk for opioid-related overdose. By eliminating the cost barrier to access, Naloxone is more readily available to be picked up by patients and it will be able to stand by in the medicine cabinet to do its job as needed. Moreover, this move is a statement by the VA of support of their at-risk patients that they value the availability of this life-saving medication and their patients lives over the cost of this drug. Next step is to incentivize increased Naloxone provider prescription levels! The U.S. Department of Veterans Affairs reported a 64% reduction in opioid use since 2012. This public information was released on July 30, 2020. The significant drop was a result of altering treatments for chronic pain. VA Secretary Robert Wilkie said, collectively, uncontrolled pain, distress, and functional impairments can reduce the quality of life of Veterans and their families, increasing the risk for overdose, substance use disorder, and suicide. The Opioid Safety Initiative also showed results of a decrease of 87% in opioid use. To prevent opioid overdose, Veterans have been given naloxone through the Opioid Overdose Education  Naloxone Distribution program. On June 30, 2020, the Drug Take Back Program reported over 193 tons of medications returned by Veterans. VA pharmacies have been conducting outreach visits and follow-ups with Veterans and staff on the effects of opioid overdose, safety when using the drug, and what and how to use naloxone. They have been working diligently to help reduce opioid use in this demographic. The Veteran Affairs Department has engaged in the opioid crisis for over 20 years. They have taken many measures to help assist Veterans who fall to opioid use. A key element is pain management and education. This area addresses self-care, improving skills, and support in pain management. The dept of Veteran Affairs provides complementary pain management treatments that discuss Whole Health and reduce pain through acupuncture, meditation, yoga, spirituality, tai chi, chiropractic care, and relaxation treatment. These therapies are put in place to improve mental health. By addressing mental and physical health simultaneously, there is hope that stress is alleviated, and there is an improvement in pain tolerance. The VA also encourages behavioral therapies to improve cognition, mindfulness-based stress, emotional awareness and expression, self-regulation, acceptance, and commitment. Behavioral interventions are expected to enhance the skills of mindfulness and understand where the pain is impacting the body. Guided Imagery is a mind-body technique that helps relieve pain and allows for visualization. Restorative therapies allow Veterans to treat pain through physical therapy, exercise, heating pads, and ice packs. Physical therapy and massages help relax muscles and joints to relieve stress and anxiety, improving mobility and strength. Veterans find relief through therapeutic exercises, aqua therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound. There are many resources Veterans can use to help aid their mind and body back to good health without the use of opioids. For opioid risk mitigation, an option is the use of naloxone rescue treatments. Proper education on naloxone should be given with frequent observations and through medical records in EMR systems. Risk assessments for respiratory depression and risk reports should be done frequently with strict regulations. These individuals who are at a high risk of an overdose of a specific substance should be closely observed. Individual therapy and group therapy with like individuals can increase therapeutic benefits. Group therapy can help individuals overcome feeling alone and build camaraderie in battling addiction and refraining from overdoses. The importance of naloxone use is a priority. Veterans should understand what medication they are taking and why it is being used; strict follow-up care is necessary to avoid abuse and overuse of drugs. Eliminating the copayment will relieve a Veteran of the financial burden while under treatment. Veterans have sacrificed enough to protect the people of this country. It is our responsibility to provide proper healthcare and encourage healthy living. Eliminating the copayment will allow a Veteran to fight this battle with focus and determination. Treatment timeframe varies per situation, but when trying to heal the mind and body simultaneously, removing a stressor can increase the chances of a successful recovery. Veterans Affairs. Go to VA.gov, 3 Nov. 2017, www.va.gov/PAINMANAGEMENT/Veteran_Public/Complementary_Treatments.asp.  The Supreme Court has generally recognized that Congress has broad constitutional authority to establish and shape the federal bureaucracy. Congress may use its Article I powers to create federal agencies and individual offices within those agencies, design agencies basic structures and operations, and prescribe, subject to certain constitutional limitations, how those holding agency offices are appointed and removed. Congress also may enumerate the powers, duties, and functions to be exercised by agencies, as well as directly counteract, through later legislation, certain agency actions implementing delegated authority. The most potent tools of congressional control over agencies, including those addressing the structuring, empowering, regulating, and funding of agencies, typically require enactment of legislation. Such legislation must comport with constitutional requirements related to bicameralism (i.e., it must be approved by both houses of Congress) and presentment (i.e., it must be presented to the President for signature). The constitutional process to enact effective legislation requires the support of the House, Senate, and the President. Even though the Department of Veterans Affairs is an executive agency, it is still subject to the same Congressional influences as a creature of statute under 5 U.S.C. 551. Under Public Laws 114-198 and 114-223, Congress properly enacted legislation that required the Department of Veterans Affairs to exempt copayments for: (1) opioid antagonizers for high-risk veterans;  and (2) educational opportunities on the use of opioid antagonizers. Thus, the VA was required to comply. The proposed rule ensures that Public Laws 114-198 and 114-223 will continue to be enforced. Furthermore, the  VA exercised its discretionary authority under 5 U.S.C 701 as an agency in explaining a definition of  high-risk veteran under the rules, as such a definition aids in the enforcement of the statutes. The VA, rather than Congress, is better equipped to devise such a definition as it is exposed to the difficulties veterans face. The judiciary has the ability to review this definition, if challenged, under 5 U.S.C. 706. However, any review would pass muster, as the definition is neither arbitrary nor capricious.  Thus, the VAs proposed rule is a fine example of an executive agency ensuring compliance with Congressional direction. 