Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response now seems to be gathering substantive momentum, with various agencies and government actors launching attacks on all fronts—administrative, legislative, and enforcement alike. The federal government’s recent efforts present opportunities for health care organizations, life sciences companies, and health tech companies to get involved at the ground level to help influence opioid policy and provide needed products, services, and support to reduce the incidence of opioid abuse and address the health care needs of patients.

Administrative Activity

  • Food and Drug Administration (FDA) Draft Guidance on Medication-Assisted Treatment for Opioid Dependence. On April 20, 2018, the FDA released the first of two draft guidance documents to help drug companies develop medication-assisted treatment (MAT) options for people with opioid use disorder (OUD). The April 20 guidance outlines the FDA’s current position on “drug development and clinical trial design issues” related to the study of the sustained-release (“depot”) version of buprenorphine, one of the three primary prescription drugs for the treatment of OUD. The guidance specifically outlines instances in which the submission of a new drug application (NDA) through § 505(b)(2) of the Federal Food, Drug, and Cosmetic Act may be appropriate, based on whether the proposed new drug (1) is similar to a drug that has already been approved, or (2) has novel features compared to an approved drug. The guidance also outlines the types of efficacy studies that the FDA recommends for depot buprenorphine drugs. Comments on the draft are due by June 22, 2018, and may be submitted via Federal Register website here.
  • The FDA’s forthcoming second guidance is intended to provide a framework for the development of novel clinical products, measures, or other “end points” that can form the basis of additional MAT approvals. No release date has been set for this guidance.
  • Omnibus Funding for Centers for Disease Control and Prevention (CDC) “Opioid Prescription Drug Overdose (PDO) Prevention Activity.” As part of its more than $1 trillion spending package passed on March 23, 2018, Congress’s Omnibus bill (H.R.1625 (115)) allocated $30 million in funding for Prescription Drug Monitoring Programs (PDMPs). Along with the legislation, the House Appropriations Committee also issued an explanatory statement that included direction to the CDC to promote the use of PDMPs, including “making them more interconnected, real-time, and usable for public health surveillance and clinical decision making.” The CDC is also “encouraged to work with the Office of the National Coordinator for Health Information Technology [ONC] to enhance the integration of PDMPs and electronic health records.”
  • Trump Administration’s “Stop Opioid Abuse and Reduce Drug Supply and Demand” Initiative. On March 18, 2018, President Trump announced the creation of his “Stop Opioid Abuse” Initiative during his speech in Manchester, New Hampshire. The Initiative includes three major components:
    1. Reduce demand and over-prescription. Part One of the Initiative is focused on educating Americans about the danger of opioids, as well as curbing the over-prescription of opioids. This portion of the Initiative would include: a nationwide evidence-based campaign to raise public awareness; supporting research and development efforts for innovative technologies and therapies to prevent addiction (including a vaccine); and implementing a “Safe Prescribing Plan” that includes creating a national interoperable PDMP.
    2. Cut off the supply of illicit drugs. This portion of the Initiative is aimed primarily at enforcement, and includes preventing opioids from entering the United States (via land, air, and sea); creating various enforcement task forces and teams (described in detail in the “Enforcement Activities” section below); and increasing criminal penalties for opioid dealers, up to and including the death penalty.
    3. Help those struggling with addiction. The third and final prong of the Initiative focuses on helping those struggling with addiction by using evidence-based treatment and recovery support services. This includes supplying first responders with naloxone to reduce overdoses; incentivizing the use and improvement of overdose tracking systems at the state and local level; and treating criminal offenders struggling with addiction.
  • National PDMP and National Electronic Prescribing Platform. On December 11, 2017, FDA Commissioner Scott Gottlieb proposed the creation of an interoperable national PDMP platform. Speaking on behalf of the FDA’s Opioid Policy Steering Committee, Gottlieb suggested that a national PDMP would help “identify patients who could be misusing or abusing prescription opioids and provide real-time alerts about potentially harmful drug-drug combinations.”Gottlieb has also called for a national e-prescribing platform, modeled after the national e-prescribing platform for Part D prescriptions proposed in the Every Prescription Conveyed Securely Act, introduced by Rep. Katherine Clark (D-MA) in July 2017.
  • President Trump himself has backed the idea, calling for the leveraging of federal funds to ensure that states transition to a national PDMP as part of his “Stop Opioid Abuse” Initiative. Additionally, the Acting Administrator of the Drug Enforcement Agency (DEA), Robert A. Patterson, testified on March 20, 2018 about the DEA’s need for a national or an interoperable PDMP solution because the DEA has had limited access to state PDMP data.
  • FDA Risk Evaluation and Mitigation Strategies (REMS) Drug Safety Programs to Educate Providers. The FDA is exploring whether it can use drug safety programs, known as REMS, to educate doctors on opioid prescribing. REMS are programs for certain medications with serious safety concerns, and are used to help ensure the benefits of the medication outweigh its risks. REMS include a risk mitigation goal, as well as information communicated to and/or required activities to be undertaken by one or more participants who prescribe, dispense or take the medication (e.g., health care providers, pharmacists, or patients). The FDA has authority to require drug manufacturers to use REMS, but does not have the authority to mandate physician education because they cannot regulate the practice of medicine. However, a national PDMP could address this authority gap.
  • On January 30, 2018, FDA Commissioner Gottlieb announced the agency’s release of a revised and updated Blueprint, “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain,” which “contains core educational messages for health care providers involved in the treatment and monitoring of patients with pain,” and also includes more information on pain management.
  • Surgeon General Advisory on Naloxone. On April 5, 2018, Surgeon General Jerome Adams issued an advisory encouraging expanded use of the overdose-reversing drug naloxone. The advisory calls on prescribers, substance use disorder treatment providers, and pharmacists to: (1) learn how to identify patients at high risk for overdose; (2) find out whether their states allow pharmacists to prescribe naloxone independently, or to dispense naloxone under a standing order or collaborative practice agreement; (3) prescribe or dispense naloxone to those at elevated risk for opioid overdose, and to their friends and family members; and (4) use their states’ PDMPs. Adams’ advisory also directs patients and the public to talk with a doctor or pharmacist about getting naloxone, learn the signs of opioid overdose, and get trained to administer naloxone.
  • FDA Commissioner Scott Gottlieb backed Adams’ recommendation and noted that the agency is encouraging drug manufacturers to develop an over-the-counter version of naloxone. While many stakeholders are proponents of the Surgeon General’s proposal, they have also raised the issue of cost as a potential barrier to supplying the drug. (The most well-known and user-friendly version of naloxone, known as Narcan, costs $125 for a two-pack for regular consumers and $75 for two doses for health departments and first responders.)

Legislative Activity

  • Recently-Introduced Legislation. Members of Congress have not been shy about making a commitment to combat the opioid epidemic—and using their legislative heft to do it. Various members of Congress on both sides of the aisle have introduced more than 25 different bills in the House and Senate over the past 2 months (building on bills introduced in 2017 during this 115th Congress), many of which have been considered and discussed during a series of legislative hearings held by the House Energy and Commerce Committee specifically focused on legislative efforts to address the opioid crisis. To show the various solutions advanced to combat the opioid epidemic, below is selected list of some of these legislative proposals.
    • Special Registration for Telemedicine Clarification Act, H.R.5483 (introduced April 12, 2018) – This bill would direct the Secretary of HHS and the Attorney General to develop interim final regulations within 30 days of enactment to enable health care practitioners to apply for a special registration. The special registration would allow practitioners to use telemedicine to prescribe controlled substances without the in-person exam requirement and other limitations on the use of telemedicine. The bill was introduced by Representatives Earl L. “Buddy” Carter (R-GA) and Cheri Bustos (D-IL).
    • The Opioid Crisis Response Act of 2018, S. ____ (discussion draft released April 4, 2018) – This draft bill from the Senate HELP Committee highlights four different agencies—the FDA, the CDC, the National Institutes of Health (NIH), and the Substance Abuse and Mental Health Services Administration (SAMHSA)—to encourage their coordination in addressing the opioid epidemic. The draft legislation contains public health approaches that significantly overlap with the Trump Administration’s “Stop Opioid Abuse” Initiative. To spur development of new treatments for pain as well as addiction, the NIH would be given special flexibility to move faster on opioid-related research. The FDA would also be tasked with helping to spur new medications by updating the development process for new non-addictive and non-opioid pain medicines.
    • The draft does not include any new funding, but does authorize the creation of a number of new grant programs and the addition of funding to existing grant programs. In coordination with SAMHSA, the draft also prioritizes funding in states with the highest overdose rates. (Lawmakers are still discussing specific funding amounts for many of the grants.) The draft legislation also authorizes new grants for communities to set up comprehensive opioid recovery centers that are required to provide medication-assisted treatment, counseling, and any inpatient treatment or housing services as needed. The draft also creates an interagency task force to help recommend best practices for supporting children and families who have experienced or are at risk of experiencing trauma, which often leads to substance abuse.
    • Stop Counterfeit Drugs by Regulating and Enhancing Enforcement (SCREEN) Act, H.R.5228 (introduced March 8, 2018) – Representative Frank Pallone, Jr. (D-NJ) introduced this bill that would increase funding to and expand the FDA’s authority to prevent illegally manufactured opioids, including heroin and fentanyl, from arriving overseas through the mail.
    • Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018, H.R.5202 (introduced March 7, 2018) – This bill, introduced by Representatives Ryan Costello (R-PA) and Rick Nolan (D-MN), would provide federal law updates to improve the dispensing of implantable and injectable therapies.
    • Alternatives to Opioids (ALTO) in the Emergency Department Act, S.2516 (introduced March 7, 2018) – This bill was authored by Reps. Bill Pascrell, Jr. (D-NJ) and David McKinley (R-WV) and aims to establish a demonstration program to test alternative pain management protocols to limit the use of opioids in hospital emergency departments.
    • CARA 2.0 Act of 2018, S.2456 (introduced February 27, 2018) – This bill reauthorizes and expands the Comprehensive Addiction and Recovery Act of 2016 by mandating that any state that receives funding under the Harold Rogers Prescription Drug Monitoring Program require its prescribing practitioners to consult the state’s PDMP before initiating treatment with a controlled substance listed in the Controlled Substances Act.
    • Protection from Overprescribing Act, S.2451 (introduced February 26, 2018) – This bill was introduced by Senator Bill Cassidy (R-LA) and requires the HHS Secretary to consider state analysis and sharing of PDMP data in determining PDMP grants to states.
    • Safe Disposal of Unused Medication Act, H.R.5041 (introduced February 15, 2018) – This bill, also introduced by Representatives Tim Walberg (R-MI) and Debbie Dingell (D-MI), aims to reduce the number of unused controlled substances at risk of diversion or misuse by allowing hospice workers to safely dispose of these medications in patients’ homes.
    • Improving Access to Remote Behavioral Health Treatment Act of 2018, H.R. ____ (discussion draft released in February 2018) – Representatives Gregg Harper (R-MS) and Doris Matsui (D-CA) introduced this draft legislation, which would allow certain addiction treatment centers and community mental health centers to register with the DEA as clinics. This draft would ultimately allow these centers to qualify for the telemedicine exception under the Ryan Haight Act of 2008, and allow them to prescribe controlled substances via telemedicine without a prior in-person examination.
    • Tableting and Encapsulating Machine Regulation Act of 2018, H.R. ____ (discussion draft released in January 2018) – This draft legislation, introduced by Representative David Kustoff (R-TN), would give the DEA the authority to regulate the use of tableting and encapsulating machines, including requirements for the maintenance of records, inspections for verifying location and stated use, and security provisions. It also gives the Attorney General the power to modify or create exceptions.
    • Indexing Narcotics, Fentanyl, and Opioids (INFO) Act, H.R.4284 (introduced November 7, 2017) – This bill was introduced by Robert E. Latta (R-OH). The bill would improve the availability of data and federal funding related to the opioid crisis by establishing a federal position to coordinate all HHS opioid-related efforts.
    • Empowering Pharmacists in the Fight Against Opioid Abuse Act, H.R.4275 (introduced November 7, 2017) – This bill, introduced by Representatives Mark DeSaulnier (D-CA) and Earl L. “Buddy” Carter (R-GA), is intended to help pharmacists detect fraudulent prescriptions. The bill helps develop and disseminate materials, giving pharmacists a greater understanding of their ability to decline to fill controlled substances when they suspect the prescriptions are fraudulent, forged, or appear to be for abuse or diversion.
    • Every Prescription Conveyed Securely Act, H.R.3528 (introduced July 28, 2017) – This bill would require the e-prescribing of schedule II, III, IV, or V controlled substances (EPCS) under Medicare Part D. The bill was introduced by Representatives Katherine Clark (D-MA) and Markwayne Mullin (R-OK), with companion legislation introduced in the Senate (S.2460) on February 27, 2018 by Senators Elizabeth Warren (D-MA), Michael Bennet (D-CO), Dean Heller (R-NV) and Pat Toomey (R-PA).
    • Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017, H.R.2851 (introduced June 8, 2017) – This bill, introduced by Representative John Katko (R-NY), would add a new schedule to the list of banned substances in the Controlled Substances Act that includes 13 synthetic drugs. It also introduces an expedited process for the Attorney General to add substances to the schedules.
    • Opioid Preventing Abuse through Continuing Education (Opioid PACE) Act of 2017, H.R.2063 (introduced April 6, 2017) – This bill, authored by Representative Brad Schneider (D-IL), aims to improve provider understanding of pain management treatment guidelines and best practices, early detection of opioid addiction, and the treatment and management of opioid-dependent patients by requiring 12 hours of continuing medical education on the topic every three years.
    • Jessie’s Law, H.R.1554 (introduced March 15, 2017) – This bill was introduced by Representatives Tim Walberg (R-MI) and Debbie Dingell (D-MI) and aims to ensure that doctors have access to a consenting patient’s prior history of addiction by requiring HHS to develop and disseminate standards for providers to include such information in patients’ medical records.
  • Congressional Committee Actions to Spur Legislation, Administrative Action, and Consider Industry Stakeholder Input. Despite the slew of legislation introduced to combat the opioid epidemic as of late, Congress is still calling for input from the industry for recommendations on how to stop opioid abuse (including in Medicare). Various committees have taken a prominent and active role in framing the dialogue around the opioid epidemic.
    • Curbing Opioid Abuse Among Medicare Part D Beneficiaries – On February 28, 2018, the House Ways & Means Committee sent a letter to CMS Administrator Verma to solicit information about CMS’ efforts given a recent HHS OIG report finding that one-third of Medicare Part D beneficiaries filled an opioid prescription, and nearly 90,000 beneficiaries received extreme amounts of opioids that year.
  • The Opioid Crisis: The Role of Technology and Data in Preventing and Treating Addiction – On February 27, 2018, the Senate Committee on Health, Education, Labor and Pensions hosted a hearing and invited stakeholders to present on how congress can utilize data and technology to prevent addiction.
    • Combatting the Opioid Crisis – As mentioned above, the House Energy & Commerce Committee has scheduled a three-part hearing throughout Spring 2018 to discuss topics related to the opioid crisis and consider relevant legislation.

Enforcement Activity

  • Department of Justice (DOJ) Prescription Interdiction & Litigation (PIL) Task Force. On February 27, 2018, Attorney General Jeff Sessions announced the creation of the Prescription Interdiction & Litigation (PIL) Task Force to “target[] opioid manufacturers and distributors who have contributed to [the opioid] epidemic.” The Task Force will use the criminal and civil penalties currently at its disposal, coordinate law enforcement activities with HHS, and explore potential legislative and regulatory changes to existing laws. It will also examine existing state and local government lawsuits against opioid manufacturers “to determine of [the DOJ] can be of assistance. The Task Force is part of the Trump Administration’s “Stop Opioid Abuse” Initiative.
  • Sessions also announced that Mary Daly – a former U.S. Attorney in the Eastern District of New York and the Eastern District of Virginia – was hired to spearhead the anti-opioid efforts as the new Director of Opioid Enforcement and Prevention Efforts. The DOJ press release is available here.
  • DOJ Joint Criminal Opioid Darknet Enforcement (J-CODE) Team. On January 29, 2018, Sessions announced the creation of the DOJ’s Joint Criminal Opioid Darknet Enforcement (J-CODE) team, a new resource available to law enforcement to help curb online opioid trafficking. J-CODE is also part of the Trump Administration’s “Stop Opioid Abuse” Initiative.
  • Curbing Opioid Use in Medicare Part D and Medicaid. In his January 17, 2018 testimony before the Subcommittee on Oversight of the House Ways & Means Committee, HHS-OIG Deputy Inspector General for Investigations Gary Cantrell identified several initiatives designed to curb and address the opioid epidemic under Medicare Part D and Medicaid:
    • Restrict certain beneficiaries to a limited number of pharmacies or prescribers;
    • Expand drug utilization review programs to include additional drugs susceptible to fraud, waste, and abuse, including HIV and antipsychotic medications that are often used in combination with opioids;
    • Require plan sponsors to report to CMS all potential fraud and abuse and any corrective actions they take in response; and
    • Improve Medicaid data by establishing a deadline for when CMS’s national Medicaid database (the Transformed Medicaid Statistical Information System (T-MSIS)) will be available for multistate program integrity efforts.
    • Cantrell’s testimony follows on the heels of a July 2017 Data Brief, in which HHS-OIG expressed concerns about the “extreme use and questionable prescribing” of opioids in Medicare Part D.” Likewise, in 2016, HHS-OIG announced that one of its top management challenges was curbing the abuse and misuse of controlled and non-controlled drugs in Medicare Part D and in Medicaid.
  • Government Accountability Office (GAO) Calls for Increased Oversight Of Medicare Part D Prescription Opioids. In response to the opioid crisis, GAO Health Care Director Elizabeth H. Curda testified before the Subcommittee on Oversight of the House Ways & Means Committee, discussing the GAO’s findings and recommendations regarding CMS oversight of prescription opioids. The GAO’s accompanying report (released in October 2017) further detailed the recommended steps necessary to combat the opioid crisis, including increased data collection by CMS, analyses, and reporting requirements for plan sponsors.
  • DEA Restrictions on Manufacture of Intravenous (IV) Forms of Opioids Create Critical Supply Shortages. On November 8, 2017, the Drug Enforcement Agency (DEA) released a final order mandating a 20% reduction in the amount of opiate and opioid medications that can be manufactured in 2018. The order established manufacture restrictions (called “aggregate production quotas” (APQs)) on the IV form of opioid painkillers – including fentanyl, ketamine, and hydromorphone – in an effort to curb the volume of such drugs entering the market. Although the APQs were instituted to restrict the presence of opioid pills in the marketplace, providers (especially hospitals) are now experiencing a critical shortage of liquid opiates necessary for general surgery anesthesia, sedation, trauma treatment, and chronic pain management. Over two-thirds of health care workers surveyed by the Institute for Safe Medication Practices reported that they were unable to give patients the recommended treatments in light of the shortages. Because the DEA’s APQs are done quarterly, the current 20% reduction is scheduled to last until at least mid-April 2018.