Submitted vie email to

Dear Chairman Alexander and Ranking Member Murray:

Thank you for your ongoing efforts to fight the opioid crisis and the opportunity to provide comments on the Opioid Crisis Response Act of 2018 (OCRA).

Addiction became personal for me and my family when I lost my son Brian to the disease on October 20, 2011. In the months that followed, it haunted me knowing how many families were being shattered every day by this disease. Shortly thereafter, I founded Shatterproof, the first national nonprofit organization dedicated to attacking addiction from all perspectives and sparing other families from the devastation my family has suffered.

Unlike most other chronic medical illnesses, substance use disorders (SUDs) have always carried a negative connotation. Years of misconstruing addiction heavily fueled our country’s public health crisis and have left the quality of SUD treatment decades behind other chronic illnesses.

As a result, the epidemic continues to worsen according to recent data from the Centers for Disease Control and Prevention (CDC), with an estimated 30 percent increase for emergency department visits due to suspected opioid overdoses from July 2016 through September 2017. In 2016 alone, opioid overdoses took the lives of over 42,000 people. While Congress has acted on the crisis in the past with the Comprehensive Addiction and Recovery Act (CARA) and 21st Century Cures Act, and most recently provided nearly $4 billion in funding through the Fiscal Year 2018 Omnibus, there is more that can and should be done.

There are a number of proposals that Shatterproof is heartened to see included in OCRA, including provisions to establish Comprehensive Opioid Recovery Centers, increase education and awareness for providers and the public through the CDC, improve existing state Prescription Drug Monitoring Programs (PDMPs), and broaden access to medication-assisted treatment (MAT). Shatterproof endorses all of these.

Shatterproof respectfully submits the following recommendations to improve provisions included in OCRA. Incorporating these components will maximize the legislation’s ability to markedly reduce the number of additional families that will have to bury their child from this tragic epidemic.

Prescribing Limitations. The discussion draft only includes a study on the impact of federal and state laws that limit opioid prescribing (Sec. 501). Shatterproof recommends including a specific limitation on opioid prescriptions for acute pain, ideally a maximum of three days with sensible exceptions for situations like chronic care and hospice. S. 2456, the CARA 2.0 Act, includes this three-day limit. We applaud language in OCRA that would provide the Food and Drug Administration (FDA) with the authority to require unit dose packaging and/or safe disposal packaging. Limiting the opioid pill count in any way possible is critical to preventing more patients from becoming addicted in the first place.

Naloxone Training and Funding. Sec. 306 of OCRA would provide funding to train first responders and other key community sectors on how to safely administer naloxone. Shatterproof also recommends providing additional funding or other means to ensure that all Americans have adequate access to naloxone; both those at risk of an opioid overdose as well as those in a position to save the lives of those experiencing an overdose. If naloxone is administered in time, it can save lives and give our loved ones a second chance.

Workforce and Treatment Capacity. Sec. 402 of OCRA would permanently allow nurse practitioners and physician assistants to prescribe buprenorphine and codify the increased prescribing limit of up to 275 patients. Shatterproof supports this, and recommends expanding the provision to additional provider types, including clinical nurse specialists, certified nurse midwives and certified registered nurse anesthetists. These changes are included in S. 2317, the Addiction Treatment Access Improvement Act. The more qualified health providers who are able to prescribe buprenorphine, the more American lives that will be saved.

Additionally, Shatterproof recommends including S. 2524, the Substance Use Disorder Workforce Loan Repayment Program Act, to allow for student loan forgiveness up to $250,000 for those who offer their training and talent in a SUD position. We desperately need more qualified health professionals in SUD professions and this student loan repayment incentive would go a long way toward meeting that need.


Improving the Effectiveness of PDMPs. Shatterproof supports Sec. 505, Preventing Overdoses of Controlled Substances, which would provide funding to encourage PDMP data sharing between states and integration of PDMPs into health information technology. Shatterproof also recommends including data analytics and SUD tools in the PDMP. Integration of interstate PDMP information and the incorporation of analytics would be very beneficial to clinicians in helping their patients.

Shatterproof strongly recommends that, after August 1, 2019, funding in Sec. 505 or any other federal stream of PDMP funding, be conditioned upon a state having met all of the following standards:

1) Mandatory query of the PDMP for schedule II, III and IV at first prescribing event and at least every 90 days thereafter;

2) Require input of dispensation information into the PDMP within 24 hours;

3) PDMP must include the most recent 12 months of prescription history (at a minimum);

4) Allow Medicare, Medicaid, health plans and pharmacy benefit managers to request access to state PDMP information; and

5) Require interstate PDMP data sharing with adjoining states (at a minimum).

The five preceding best practices have all been recommended in numerous white papers on the opioid crisis, and not including them in the final opioid package would be a lost opportunity to save countless American lives.


Changes to 42 CFR Part 2. We support Sec. 507 (Jessie’s Law) and Sec. 508 (Development and Dissemination of Model Training Programs for Substance Use Disorder Patient Records) to improve best practices for SUD information in patient records and offer more provider education in this area. This is crucial to ensuring patients feel comfortable knowing their sensitive information is handled properly and protected appropriately.

Shatterproof encourages the Committee to take this issue a step further and consider the House amendment in the nature of a substitute (AINS) to H.R. 3545, the Overdose Prevention and Patient Safety Act. We think this amendment, offered by Rep. Markwayne Mullin, strikes the right balance between allowing SUD records to be shared for the purposes of treatment in accordance with the Health Insurance Portability and Accountability Act (HIPAA), while also providing protections for discrimination or unauthorized disclosure.

One of the most important factors in successful treatment is coordination of care among the various professionals treating a patient. This can be accomplished most effectively through the use of EHRs; however, in order to be effective, the EHRs need all relevant patient information including SUD records. The changes made by the AINS will allow for the inclusion of this vital information in EHRs which will save lives by improving care coordination while strengthening HIPAA protections for this sensitive patient information. Moreover, this also supports the important goal of ending the shame and stigma that has deterred far too many Americans afflicted with this disease from accessing treatment.

In addition to the improvements outlined above, the discussion draft does not include any language addressing the following critical issues that Shatterproof strongly recommends incorporating into the final version of OCRA:

Evidence-Based Treatment. H.R. 5272, the Reinforcing Evidence-Based Standards Under Law in Treating Substance Abuse (RESULTS) Act (no Senate companion bill introduced), would require applicants for mental health or substance use disorder funding to demonstrate to HHS that the prevention or treatment activities are evidence-based. A large part of federal funding goes to prevention and treatment that is based on outdated methods, rather than programs that utilize research proven to save American lives. In fact, SAMHSA’s National Survey of Substance Abuse Treatment Services for 2016 (p. 27), only 9 percent of specialty addiction treatment facilities offered methadone, only 27 percent of treatment programs offered buprenorphine, and only 21 percent offered extended-release injectable naltrexone. Tragically, less than one percent of facilities offered both methadone in addition to buprenorphine and/or naltrexone.

The RESULTS Act would make significant progress towards incentivizing evidence-based approaches, while including a sensible exception for innovative programs.

Provider Training Requirements. H.R. 2063, the Opioid PACE Act (no Senate companion bill introduced), would improve provider education on SUD issues by requiring training as a condition of obtaining and renewing a controlled substance registration with the Drug Enforcement Administration (DEA). It is critical that those who prescribe opioids have the proper training to do so, and therefore Shatterproof also strongly recommends the following additions to the Opioid PACE Act, if the Committee includes it:

1) Include language to ensure that the Department of Health Human Services (HHS) may only establish or support training modules that adhere to the Centers for Disease Control (CDC) Guideline for Prescribing Opioids for Chronic Pain.

2) Add a requirement that any provider obtaining or renewing a DEA registration number also be required to complete the Drug Addiction Treatment Act (DATA) 2000 waiver application process which would save many lives by increasing the number of qualified providers that are eligible to prescribe buprenorphine to treat opioid addiction.

Health Information Technology for Behavioral Health Providers. S. 1732, the Improving Access to Behavioral Health Information Technology Act, would provide long overdue incentive payments to behavioral health providers for adopting certified EHR technology, via a Center for Medicare and Medicaid Innovation (CMMI) demonstration. As you know, behavioral health providers were left out of the HITECH Act funding in 2009 for incentives to adopt electronic health records. Research has proven that one of the most important factors in successful treatment is coordination of care among the various professionals treating a patient. It is only right and morally just that these providers are able to adopt health IT to ensure care coordination with other provider types, just like any other disease.

Enforcement of the Mental Health and Addiction Equity Act of 2008. S. 2301, the Behavioral Health Coverage Transparency Act, would require health plans to disclose additional information to better assess how the law is being implemented. The bill would also require a minimum of 12 random audits per year to ensure the law is being implemented and enforced. We must ensure this law is being implemented fully to make treatment available to those who are dealing with addiction.

Best Practices for Post-Overdose Care. S. 2610, the Preventing Overdoses While in Emergency Departments Act, would create a pilot program with 20 health care facilities to develop best practices for emergency departments as they discharge patients who have had an overdose. With opioid overdoses increasing, improving post-overdose care with proven best practices is crucial to helping patients get a second chance.

I strongly encourage you to include the recommendations and proposals outlined above in any final package. These will make a lasting and meaningful impact on the opioid epidemic in the near-term and for years to come.

Every morning, I wake up thinking of the Serenity Prayer. The serenity to accept what I cannot change, and the courage to change the things we can. Our society must find the serenity to accept the lives that have already been lost, but waste no time in working together across party lines to find “the courage to change the things we can” and save countless lives. If there is anything that Shatterproof can do to assist in your efforts, please do not hesitate to call on us.


Gary Mendell

Founder & CEO, Shatterproof