On Tuesday, the House of Representatives passed a fleet of bills aimed at combating the ongoing opioid crisis, most aimed at developing preventative measures to curb opioid addiction by funding research. The measures passed with overwhelming bipartisan support. Key points of these legislative initiatives are summarized below. Quarles & Brady will continue to monitor their progress.

H.R. 4275 – Empowering Pharmacists in the Fight Against Opioid Abuse Act

The Empowering Pharmacists in the Fight Against Opioid Abuse Act aims to provide pharmacists with more resources to understand common fraudulent prescription practices and when they may decline to fill prescriptions. The bill requires that agencies develop reference materials for pharmacists to consult so they are aware of their authority to decline to dispense controlled substances, and for prescribers and the general public to raise awareness on fraudulent prescriptions.

Common examples of fraudulent prescriptions include:

• Prescriptions written on stolen prescription pads for fictitious patients;
• Patient-altered prescriptions to increase quantities or dosage strength;
• Computer-generated prescriptions that copy legitimate doctors’ prescriptions or create prescriptions for nonexistent doctors.

H.R. 5197 – the Alternatives to Opioids (ALTO) Act

Recent CDC reports show a rise in emergency room visits related to opioid overdoses. The Alternatives to Opioids Act authorizes $10 million in annual grants to develop pilot programs for emergency departments exploring alternative pain management protocols. The Act aims to support emergency departments as the “first line of defense” against the opioid crisis, as they have contact with many patients who otherwise do not interact with the healthcare system. The bill is named after the Alternatives to Opiates (ALTO) program developed at St. Joseph’s Medical Center in Paterson, New Jersey, which decreased emergency department opioid prescriptions by more than 80 percent in two years.

H.R. 5812 – the Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigation Strategies Act

While many states require the use of Prescription Drug Monitoring Programs (PDMPs), standards for reporting vary from state to state. The Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigation Strategies Act gives the Centers for Disease Control (CDC) legal authority and funding to provide technical training and support to state PDMPs to improve their existing systems, increase data sharing and facilitate the transmittal of PDMP information across state lines. As a condition of receiving this funding, states must demonstrate they have enacted laws or regulations related to the implementation of PDMP and implemented penalties for misuse of PDMP information. Providers should monitor state PDMP changes that may follow the implementation of a more robust interstate PDMP program.

H.R. 5327 – Comprehensive Opioid Recovery Centers Act of 2018 

This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to award grants to establish or operate comprehensive opioid recovery centers. It mandates that each center provide specific treatment and recovery services, and also conduct outreach activities. Required services, which can be provided by the center or via coordination with other entities, include: withdrawal management, counseling, recovery housing, community-based and peer recovery support services, job training and placement assistance, pharmacy and toxicology services, and a secure and confidential electronic health information system. The bill provides that states with a high per capita drug overdose mortality rate will be given priority for grant awards. The goal for this bill is to provide a full range of Food and Drug Administration (FDA)-approved treatments across and wide range of communities and to generate data for further research.

H.R. 5041 – Safe Disposal of Unused Medication Act

While the Drug Enforcement Administration (DEA) currently encourages hospice staff to discuss destruction of leftover medications with patient families, DEA regulations explicitly prohibit hospice employees from personally disposing of any medications unless they are authorized to do so by state law. The Safe Disposal of Unused Medication Act requires providers of hospice care to develop written policies and procedures that address the disposal of these drugs, and grants limited authority to hospice employees to handle controlled substances found after the death of a patient in order to ensure their safe disposal. Hospice providers will need to monitor the passage of this bill and any future guidelines provided for drafting employee controlled substance disposal policies.

H.R. 5002 – The Advancing Cutting Edge (ACE) Research Act

The ACE Research Act is aimed at giving the National Institutes of Health (NIH) more expansive authority to research new non-addictive pain medications and technologies to provide more alternatives to opioids. The act also provides more flexibility for the agency to partner with private companies doing research to combat the opioid epidemic and address other threats to public health. If passed, this bill will allow the NIH to more quickly respond to public health threats rather than waiting for Congressional grants to do so.

H.R. 5473 – Better Pain Management Through Better Data Act of 2018

H.R. 5473, the Better Pain Management Through Better Data Act of 2018, directs the FDA to hold a public meeting and issue guidance to industry addressing data collection and labeling for medical products that reduce pain and may replace, delay, or reduce the use of oral opioids. According to the House, while there are alternatives to opioids for certain patients and conditions, there is a need for additional clarity and flexibility regarding the process drug developers need to follow in order to show that their products can spare certain patients from opioids as part of their treatment regimen. The bill intends to facilitate better clinical data on non-opioid alternatives so prescribers have more options. The end result would mean fewer opioids are prescribed, which would ideally lower the rate of addiction.

H.R. 5009 – Jessie’s Law

H.R. 5009, Jessie’s Law, calls for the HHS to develop and disseminate best practices regarding the prominent display of opioid use disorder history in medical records of patients who have previously provided this information to a health care provider. According to the bill, best practices include:

• The potential for addiction relapse or overdose death if opioid medications were prescribed to treat opioid use disorder;
• The benefits of displaying the opioid use disorder history similarly to other potentially lethal medical concerns, such as drug allergies;
• The importance of prominently displaying of past opioid use disorder when a physician or medical professional is prescribing medication;
• The importance of a variety of medical professionals to have access to the opioid addiction history when prescribing or dispensing opioid medication;
• The importance of protecting patient privacy; and
• Other applicable federal laws and regulations.

The bill specifies that the above-listed best practices must allow for the patient to elect to have the opioid use disorder history displayed in medical records. Those that endorsed the bill explain that this will provide physicians and other medical professionals with information at every step of the patient’s care enabling them to consider the patient’s addiction when determining the appropriate medical care.

H.R. 4284 – Indexing Narcotics, Fentanyl and Opioids (INFO) Act of 2017

In response to the opioid crisis, HHS is focusing its efforts on improving access to treatment and recovery services, advancing public health surveillance, providing support through research, and advocating for better practices for pain management. One such effort includes H.R. 4284, Indexing Narcotics, Fentanyl and Opioids (INFO) Act of 2017. The INFO Act directs HHS to create a public and easily accessible electronic database linking to all of the nationwide efforts to combat the opioid crisis. The Secretary of HHS will appoint a Federal Coordinator within HHS to oversee implementation and coordination of the public database in partnership with other government agencies. The database will serve as a central location for the public and others to track federal funding allocations made available for research and treatment of opioid abuse and identify research relating to opioid abuse from all federal agencies, state, local, and tribal governments, as well as non-profits, law enforcement, medical experts, public health educators, and research institutes. This database will ease tracking of federal and state programs and provide a better and more complete understanding of programs that display positive progress and identify those that require additional scrutiny.

In addition, the legislation creates an Interagency Substance Use Disorder Coordinating Committee to review and coordinate opioid use disorder and other substance use disorder research, services, and prevention activities across all relevant Federal agencies. This Committee will evaluate the effectiveness of the federal opioid and substance use disorder activities, and make specific recommendations for actions that agencies can take to better coordinate the administration of services for patients with opioid or substance use disorders.

H.R. 5353 – Eliminating Opioid Related Infectious Diseases Act of 2018

Injection drug-use is the most well-known route for the transmission of blood borne infections, particularly human immunodeficiency virus (HIV) and hepatitis. H.R. 5353, Eliminating Opioid Related Infectious Diseases Act of 2018, intends to combat such infections that are frequently associated with opioid use. The bill authorizes the Centers for Disease Control (“CDC”) to undertake an injection drug-use associated infection elimination initiative and work with states to improve education, surveillance, and treatment of infections associated with injection drug use. The bill would amend the Public Health Service Act by broadening the focus of surveillance and education programs from preventing and treating hepatitis C virus to preventing and treating infections associated with injection drug use. According to Dr. Michael E. Kilkenny, the physician director of the Cabell-Huntington Health Department in Huntington, West Virginia, who testified at a two-day hearing held by the Energy and Commerce Health Subcommittee, by expanding the bill to include CDC surveillance program that includes HIV, HBV, and HCV, the program would be positioned to “help identify where new incidences of infection are occurring fastest, and accordingly target areas to help reduce the greatest burden of infection and support prevention programs.”

H.R. 5483 – Special Registration for Telemedicine Clarification Act of 2018

The Ryan Haight Act required DEA to promulgate regulations establishing a telemedicine registration category.  DEA has yet to promulgate such regulations.  H.R. 5483, Special Registration for Telemedicine Clarification Act of 2018, directs the Department of Justice (“DOJ”) to improve flexibility in the practice of telemedicine for the purposes of remote diagnosis and treatment of patients. Specifically, the bill requires DOJ to allow for the prescription of medication-assisted treatment (MAT) and other controlled substances via telemedicine. This would require a special registration to connect patients with the treatment they need without risking important safeguards to prevent misuse. Ultimately, passage of this bill would clarify telemedicine waivers so that patients can more easily be prescribed controlled substances in legitimate emergency situations.

H.R. 5582 Abuse Deterrent Access Act of 2018

H.R. 5582, Abuse Deterrent Access Act of 2018, requires the Secretary of HHS to report to Congress on existing barriers to access “abuse-deterrent opioid formulations” by Medicare Part C and D beneficiaries. Abuse deterrent formulations (ADFs) represent a breakthrough technology that helps prevent the tampering with painkillers For example, such formulations make it more difficult to dissolve for injection, and thus can impeded opioid abuse. Currently, many prescription drug plans present access barriers for chronic pain patients to ADFs including cost-sharing tiers, fail-first requirements, and prior authorization requirements. Instead of receiving ADFs, often patients are limited to using traditional opioids that can be easily diverted, crushed, snorted, and injected. By increasing access and use of this technology, opioid abuse and tampering can be hindered.