Today, President Obama announced several public and private sector actions to escalate the fight against the prescription opioid abuse and heroin epidemic, which is claiming the lives of tens of thousands of Americans each year. Included in the President’s announcement, as well as remarks to be delivered at the National Rx Drug Abuse and Heroin Summit in Atlanta, GA, by SAMHSA Principal Deputy Administrator Kana Enomoto, are several initiatives being led by the Substance Abuse and Mental Health Services Administration (SAMHSA), including the new buprenorphine rule on increased access:
One of the important steps that the Department of Health and Human Services (HHS) is taking to address the opioid crisis is looking at ways to increase access to Medication-Assisted Treatment (MAT). As part of this effort to expand the use of MAT, SAMHSA, in collaboration with the Office of the Assistant Secretary for Planning and Evaluation (ASPE), the HHS Office of General Counsel, and other HHS components has been exploring efforts to increase access to buprenorphine. We are happy to announce that we have taken a major step forward in this process and that at 8:45 AM, a Notice of Proposed Rulemaking (NPRM) to expand access to buprenorphine went on display in the Federal Register.
Under current regulations, physicians that are certified to prescribe buprenorphine for MAT are allowed to prescribe up to 30 patients initially and then after one year can request authorization to prescribe up to a maximum of 100 patients. This cap on prescribing limits the ability of some physicians to prescribe to patients with opioid use disorder. If adopted, the proposed rulemaking would allow for a qualified and currently waivered physician to prescribe buprenorphine for up to 200 patients. Existing evidence shows that this lifesaving, evidence-based treatment is under-utilized. This proposed expansion is especially important to people who are seeking help for an untreated opioid use disorder. In many cases there are long waiting lists of patients for prescribers who have reached the 100 patient limit. Easing additional barriers to treatment, such as this cap, is a major step HHS is taking to help reduce prescription opioid and heroin related overdose, death, and dependence. The proposed rule is designed to strike an appropriate balance between expanding access to this important treatment, encouraging use of evidence-based MAT, and minimizing the risk of drug diversion.
HHS welcomes public comment on this proposed rule, which will be open for comment for 60 days starting Wednesday, March 30, 2016.
Additionally, we thought you might be interested in watching President Obama speak today at 2:15 pm ET at the 2016 National Rx Drug Abuse and Heroin Summit. Below is a letter from White House Office of National Drug Control Policy Director Michael Botticelli with details.
Watch President Obama Speak at the 2016 National Rx Drug Abuse and Heroin Summit
Administration Announces Additional Actions to Address the Prescription Opioid Abuse and Heroin Epidemic
I'm here in Atlanta at the 2016 National Rx Drug Abuse & Heroin Summit gearing up to hear the President speak on how we turn the corner on this national epidemic. Join me at 2:15pm (EST) today at WH.Gov/Live to watch President Obama's conversation with community leaders and advocates at the Summit, including people in recovery.
During his conversation, the President will talk about the challenges we face with prescription drug misuse and heroin use. He will also talk about the actions we are taking - and need to take - to prevent more people from developing opioid use disorders and to make sure those who want treatment can access it.
The President has made clear that addressing this epidemic is a priority for his Administration - and should be a bipartisan priority for all Americans. And that's why - building on his $1.1 billion budget proposal to help every American seeking treatment get the care they need - the President announced additional public and private sector actions to help more families.
Today, the Administration is:
- Expanding access to treatment through doctors, community health centers, and state programs.
- Investing in partnerships between law enforcement and communities.
- Working to save more lives by making the overdose reversal drug naloxone more readily available to first responders.
- Ensuring those on Medicaid and CHIP can access mental health and substance use services as readily as medical services.
- Pulling together medical schools to train students on the newest CDC guidelines on prescribing opioid painkillers.
The President has made clear that addressing this epidemic is a priority for his Administration, and today's actions represent further steps to expand access to treatment, prevent overdose deaths and increase community prevention strategies.
Again, I hope that you can join me in watching the President talk about this epidemic today at 2:15pm (EST) at WH.Gov/Live.
Michael P. Botticelli
Director, National Drug Control Policy
THE WHITE HOUSE
Office of the Press Secretary
FACT SHEET: Obama Administration Announces Additional Actions to Address the Prescription Opioid Abuse and Heroin Epidemic
Today the President joins individuals in recovery, family members, medical professionals, law enforcement officials and other leaders at the National Rx Drug Abuse and Heroin Summit in Atlanta, Georgia. The annual summit is organized by Operation UNITE, which was launched by Congressman Hal Rogers (R-KY). As part of today's event, the President is announcing additional public and private sector actions to escalate the fight against the prescription opioid abuse and heroin epidemic, which is claiming the lives of tens of thousands of Americans each year.
The President has made clear that addressing this epidemic is a priority for his Administration, and today's actions represent further steps to expand access to treatment, prevent overdose deaths and increase community prevention strategies. These actions build on the President's proposal for $1.1 billion in new funding to help every American with an opioid use disorder who wants treatment get the help they need.
As part of today's event, the President will announce the following Administration actions:
• Expanding Access to Treatment:
The Department of Health and Human Services (HHS) is issuing a proposed rule to increase the current patient limit for qualified physicians who prescribe buprenorphine to treat opioid use disorders from 100 to 200 patients with the goal of expanding access to this evidence-based treatment while preventing diversion. The proposed rule aims to increase access to medication-assisted treatment and behavioral health supports for tens of thousands of people with opioid use disorders.
HHS released $94 million in new funding to 271 Community Health Centers across the country earlier this month to increase substance use disorder treatment services, with a specific focus on expanding medication-assisted treatment of opioid use disorders in underserved communities. This funding is expected to help health centers treat nearly 124,000 new patients with substance use disorders.
The Substance Abuse and Mental Health Services Administration (SAMHSA) is releasing a new $11 million funding opportunity for up to 11 States to expand their medication-assisted treatment services. SAMHSA also is distributing 10,000 pocket guides for clinicians that include a checklist for prescribing medication for opioid use disorder treatment and integrating non-pharmacologic therapies into treatment. SAMHSA also will coordinate trainings to increase the number of doctors qualified to prescribe buprenorphine, which will be held in targeted States in greatest need.
• Establishing a Mental Health and Substance Use Disorder Parity Task Force:
The President is signing a Memorandum today directing the creation of an interagency Task Force, to be chaired by the Domestic Policy Council, to advance access to mental health and substance use disorder treatment; promote compliance with best practices for mental health and substance use disorder parity implementation; and develop additional agency guidance as needed. Federal parity protections are intended to ensure that health plans' coverage of mental health and substance use disorder benefits is comparable to their coverage of medical and surgical benefits. The Task Force will work quickly, with an October 31 deadline, across Federal Departments and with diverse stakeholders to ensure implementation of these important parity protections.
• Implementing Mental Health and Substance Use Disorder Parity in Medicaid:
HHS is finalizing a rule to strengthen access to mental health and substance use services for people enrolled in Medicaid and Children's Health Insurance Program (CHIP) plans by requiring that these benefits be offered at parity, meaning that they be comparable to medical and surgical benefits. These protections are expected to benefit more than 23 million people in Medicaid and CHIP.
• Preventing Opioid Overdose Deaths:
SAMHSA is releasing a new $11 million funding opportunity to States to purchase and distribute the opioid overdose reversal drug, naloxone, and to train first responders and others on its use along with other overdose prevention strategies.
• Expanding Public Health-Public Safety Partnerships to Combat the Spread of Heroin:
The Office of National Drug Control Policy is expanding its heroin initiative among regional High Intensity Drug Trafficking Areas (HIDTAs) by adding Ohio and Michigan to the effort. These States will join the Appalachia, New England, Philadelphia/Camden, New York/New Jersey, and Washington/Baltimore HIDTAs in accelerating local partnerships between law enforcement and their counterparts in public health to combat heroin use and overdose.
• Investing in Community Policing to Address Heroin:
The Department of Justice's COPS program is announcing a $7 million funding opportunity called the COPS Anti-Heroin Task Force Program to advance public safety and to investigate the distribution of heroin, unlawful distribution of prescription opioids and unlawful heroin and prescription opioid traffickers. These grants will provide funds directly to law enforcement agencies in States with high rates of primary treatment admissions for heroin and other opioids.
• Tackling Substance Use Disorders in Rural Communities:
On Monday, the Department of Agriculture announced that its $1.4 million Rural Health and Safety Education Grant Program to enhance the quality of life in rural areas through health and safety education projects has been expanded to include a focus on addressing the critical challenges related to substance use disorders in rural communities across the country.
• Implementing Syringe Services Programs:
HHS is issuing guidance for HHS-funded programs regarding the use of Federal funds to implement or expand syringe services programs for people who inject drugs. Syringe services programs are an effective component of a comprehensive approach to preventing HIV and viral hepatitis among people who inject drugs. The bipartisan budget agreement signed by the President last year revised a longstanding ban on these programs and allows communities with a demonstrated need to use Federal funds for the operational components of syringe services programs.
New Private Sector Commitments to Address the Epidemic
In connection with today's Federal announcements, more than 60 medical schools are announcing that, beginning in fall 2016, they will require their students to take some form of prescriber education, in line with the newly released Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain, in order to graduate. Schools include:
• A.T. Still University of Health Sciences, Kirksville College of Osteopathic Medicine
• A.T. Still University of Health Sciences, School of Osteopathic Medicine in Arizona
• Baylor College of Medicine
• Boston University School of Medicine
• Burrell College of Osteopathic Medicine at New Mexico State University
• Chicago College of Osteopathic Medicine of Midwestern University
• David Geffen School of Medicine at the University of California - Los Angeles
• Dell Medical School at The University of Texas at Austin
• East Carolina University Brody School of Medicine
• Edward Via College of Osteopathic Medicine - Auburn Campus
• Edward Via College of Osteopathic Medicine - Carolinas Campus
• Edward Via College of Osteopathic Medicine - Virginia Campus
• Georgia Campus - Philadelphia College of Osteopathic Medicine
• Hébert School of Medicine Uniformed Services University of the Health Sciences
• Icahn School of Medicine at Mount Sinai
• Kansas City University of Medicine and Biosciences College of Osteopathic Medicine
• Lincoln Memorial University DeBusk College of Osteopathic Medicine
• Loyola University Chicago Stritch School of Medicine
• Marian University College of Osteopathic Medicine
• Marshall University Joan C. Edwards School of Medicine
• Mercer University School of Medicine
• NYU School of Medicine
• Ohio State University College of Medicine
• Ohio University Heritage College of Osteopathic Medicine
• Oklahoma State University Center for Health Sciences College of Osteopathic Medicine
• Oregon Health & Science University School of Medicine
• Perelman School of Medicine at the University of Pennsylvania
• Philadelphia College of Osteopathic Medicine
• Rocky Vista University College of Osteopathic Medicine
• Rowan University School of Osteopathic Medicine
• Rutgers Robert Wood Johnson Medical School
• Saint Louis University School of Medicine
• State University of New York Upstate Medical University
• The Commonwealth Medical College
• The Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo
• Touro College of Osteopathic Medicine - New York
• Touro University College of Osteopathic Medicine - California
• Touro University College of Osteopathic Medicine - Nevada
• Tufts University School of Medicine
• Tulane University School of Medicine
• University of Arizona College of Medicine - Tucson
• University of California - Davis School of Medicine
• University of Central Florida College of Medicine
• University of Colorado School of Medicine
• University of Kansas Medical Center
• University of Louisville School of Medicine
• University of New England College of Osteopathic Medicine
• University of North Carolina School of Medicine
• University of North Texas Health Science Center at Fort Worth, Texas College of Osteopathic Medicine
• University of Oklahoma College of Medicine
• University of Pikeville - Kentucky College of Osteopathic Medicine
• University of Rochester School of Medicine and Dentistry
• University of Tennessee College of Medicine
• University of Texas Southwestern Medical Center
• University of Wisconsin School of Medicine and Public Health
• Virginia Commonwealth University School of Medicine
• West Virginia School of Osteopathic Medicine
• West Virginia University School of Medicine
• Western University of Health Sciences College of Osteopathic Medicine of the Pacific
• Western University of Health Sciences College of Osteopathic Medicine of the Pacific Northwest
• William Carey University College of Osteopathic Medicine
Rite Aid has trained over 8,400 pharmacists on naloxone and is dispensing naloxone to patients without needing an individual prescription in 10 States with plans to expand to additional States. Kroger currently dispenses naloxone without an individual prescription at its pharmacies in 7 States with plans to expand to at least 12 more by the end of the year. AmerisourceBergen/Good Neighbor Pharmacy will provide educational materials to encourage their 4,000 independently owned and operated retail pharmacy locations to provide naloxone without an individual prescription.
Updates on Federal Actions and Private Sector Commitments
In October 2015, as part of his visit to West Virginia to discuss the prescription opioid abuse and heroin epidemic, the President announced a number of new public and private sector actions , including a Presidential Memorandum requiring Federal Departments to provide training on appropriate opioid prescribing to Federal health care professionals and requiring Departments to develop plans to address barriers to opioid use disorder treatment in Federal programs. Departments are ahead of schedule in fulfilling the President's directive that Federal agencies ensure that all employees who prescribe these drugs are trained in appropriate opioid prescribing practices by 2017. Approximately 75 percent of federal prescribers have been trained to date. In addition, since the President's Memorandum was released, Departments have taken numerous steps to expand access to opioid use disorder treatment, including medication-assisted treatment, such as:
• TRICARE: The Department of Defense issued a proposed rule to implement parity protections in TRICARE, including expanding mental health and substance use disorder treatment to include coverage of intensive outpatient programs and treatment of opioid use disorders with medication-assisted treatment. TRICARE currently has an estimated 15,000 to 20,000 beneficiaries with opioid use disorder who, under the current benefit, cannot access medication-assisted treatment.
• FEHBP: The Office of Personnel Management released a 2017 Call Letter to health plans participating in the Federal Employees Health Benefits Program (FEHBP) making opioid use disorder treatment a priority and calling on health plans to review and improve access to medication-assisted treatment.
• Medicare: The Centers for Medicare and Medicaid Services (CMS) released a 2017 Call Letter to plans participating in the Medicare Prescription Drug Program reiterating that reducing the unsafe use of opioids is a priority and making clear that Part D formulary and plan benefit designs that hinder access to medication-assisted treatment for opioid use disorder will not be approved.
• Medicaid: CMS released a guidance document to States identifying "Best Practices for Addressing Prescription Opioid Overdoses, Misuse and Addiction" including effective Medicaid pharmacy benefit management strategies, steps to increase the use of naloxone to reverse opioid overdose, and options for expanding Medicaid coverage of and access to opioid use disorder treatment. This builds on Medicaid's work with States over the past year to increase access to Medicaid substance use disorder treatment services.
• Health Insurance Marketplace: In the last month, CMS finalized a 2017 Marketplace payment notice that clarified that both essential health benefits requirements and Federal mental health and substance use disorder parity requirements apply to qualified health plan coverage of medications to treat opioid use disorder, and additional guidance is forthcoming.
Earlier this month, the Centers for Disease Control and Prevention issued its Guideline for Prescribing Opioids for Chronic Pain - the Agency's first-ever recommendations for primary care clinicians on prescribing opioids. The Guideline provides recommendations for clinicians on appropriate prescribing, including determining if and when to start prescription opioids for chronic pain treatment; guidance on medication selection, dose, and duration, including when to discontinue medication, if needed; and guidance to help assess the benefits and risks and address the harms of prescription opioid use.
The Food and Drug Administration recently announced safety labeling changes for all immediate-release opioid pain medications, including requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death associated with these drugs. The Agency also issued a draft guidance intended to support the development of generic versions of abuse-deterrent opioids. Abuse-deterrent drug formulations are designed to make the drug more difficult to abuse, including making it harder to crush a tablet in order to snort the contents or more difficult to dissolve the product in order to inject it.
The Drug Enforcement Administration (DEA) recently announced it will hold its 11th National Prescription Drug Take-Back Day on Saturday, April 30, providing a safe, convenient, and responsible way of disposing of unneeded prescription drugs. More than 5.5 million pounds of medication have been collected over the last ten Take Back Days. Local communities are also establishing ongoing drug take-back programs.
Examples of private sector actions taken to date include the following:
In conjunction with the October event, more than 40 health care provider groups announced a commitment to ensure that more than 540,000 health care providers will complete training on appropriate opioid prescribing in the next two years. In the first five months of this initiative, the provider coalition reports that more than 75,000 providers have completed prescriber training. In addition, more than 2,200 additional physicians have committed to completing training to prescribe buprenorphine as part of the coalition's effort to double the number of buprenorphine prescribers in the next three years.
As part of their commitment announced at the October 2015 event, the National Association of Counties, National Governors Association, National League of Cities and United States Conference of Mayors, with the U.S. Communities Purchasing Alliance and Premier, Inc., announced in January they had secured discounts on naloxone and medication-assisted treatment drugs through their purchasing program for State and local agencies.
In February, Walgreens announced it will install safe medication disposal kiosks in more than 500 drugstores across the country, primarily at locations open 24 hours. The program will make the disposal of medications - including opioids and other controlled substances - easier and more convenient while helping to reduce the misuse of medications. Walgreens also will make naloxone available without needing an individual prescription at its pharmacies in 35 States and Washington, D.C. throughout this year.
CVS Health has worked to increase access to naloxone by establishing standing orders or collaborative practice agreements. By the end of March 2016, CVS Pharmacy locations in 23 States will be able to dispense naloxone to patients without needing an individual prescription, increasing to 35 States by the end of 2016 as part of its program expansion announced at the October 2015 event. CVS Health has also launched a drug abuse prevention program called Pharmacists Teach, which brings CVS Pharmacists into schools across the country to educate students about the dangers of drug abuse. To date, more than 30,000 students have participated in the program.