It’s all about opioids as the U.S. House of Representatives considers dozens of bills to help tackle this epidemic, which claims 116 lives each day across the country. Senate Committees are also advancing bills that likewise incorporate dozens of proposals. There is tremendous pressure on lawmakers to pass something – anything before the November elections. BPC commends Congress’s hard work, and we agree this crisis deserves intense national focus and the bipartisan collaboration of Members of Congress from every state and congressional district.
However, will enacting hundreds of well-intentioned policy proposals reduce opioid overdose deaths, the numbers of newly addicted Americans, and the costs to society? Perhaps, but there are still many unknowns. What we do know is that there are several simple, inexpensive policy reforms that could meaningfully address two core problems: 1) the overprescribing of opioids, and 2) the underutilization of evidence-based medication-assisted therapy (MAT) for treating those with opioid use disorder (OUD).
What we do know is that there are several simple, inexpensive policy reforms that could meaningfully address two core problems: 1) the overprescribing of opioids, and 2) the underutilization of evidence-based medication-assisted therapy (MAT) for treating those with opioid use disorder (OUD).
Reducing the overprescribing of opioids:
- Require provider education on proper opioid prescribing and addiction to obtain and renew a federal Drug Enforcement Agency (DEA) license to prescribe controlled substances. The course could be designed by medical specialty societies as appropriate by medical specialty and certified by the U.S. Department of Health and Human Services (HHS) Secretary. Such a training could cover topics outlined in the Center for Disease Control and Prevention’s (CDC’s) recent opioid prescribing guidelines, such as the effectiveness of opioids in treating acute and chronic pain, harms and adverse events, dosing strategies, patient risk assessment and risk mitigation strategies. It could also include general concepts related to pain management and addiction medicine.
Currently any licensed prescriber can obtain a three-year DEA license to prescribe opioids by writing a check and submitting an online form. No training is required, despite the risks associated with opioids and other controlled substances. And yet, to treat addicted individuals using medication-assisted treatment, health care providers must undergo eight-to-24 hours of training. Tying the DEA license to appropriate training could provide some much-needed parity and significantly improve prescribers’ understanding of the prescribing benefits and risks associated with opioid drugs.
One bipartisan bill which has yet to advance through House committees – H.R. 5581, sponsored by Rep. Brad Schneider (D-IL) and Rep. Susan Brooks (R-IN) – would require providers who treat patients with prescription opioids for pain management to complete three hours of continuing medical education (CME) on opioid addiction and its prevention and treatment to register for and renew a DEA license.
- Limit initial opioid prescriptions for acute pain treatment to seven days, with appropriate exceptions for chronic pain, cancer, hospice and palliative care, consistent with 2016 Centers for Disease Control and Prevention (CDC) prescribing guidelines. There is clear consensus that there are too many prescriptions for opioids for too many days at too high a dose. For example, in 2015 the sheer quantity of opioids prescribed by health care professionals was enough for every American to be medicated around the clock for three weeks. Currently, over 25 states have established prescribing limits of seven days or less, many health plans and chain pharmacies are instituting voluntary limits, and the Centers for Medicare and Medicaid Services (CMS) will require Medicare Part D prescription drug plans to implement a seven-day initial prescribing limit beginning in 2019.
The Opioid Crisis Response Act (S.2680) approved by the Senate Health, Education, Labor and Pensions (HELP) Committee would not institute a duration limit but instead would require the HHS Secretary to issue a report on the impact of federal and state laws regulating the length, quantity, or dosage of opioid prescriptions. Another bill, known as “CARA 2.0,” introduced by Senators Rob Portman (R-OH) and Sheldon Whitehouse (D-RI), proposes a three-day limit.
Reducing opioid prescribing by itself is insufficient to curb high rates of opioid involved overdose rates. It is also necessary to address the needs of individuals with current opioid use disorders.
Reducing the barriers to treatment with highly effective medication-assisted therapy:
- Reassess the current training requirements to obtain a waiver to prescribe medication-assisted therapy to treat opioid use disorder. Of the almost one million physicians in the United States, only 48,871 have the appropriate waiver to prescribe buprenorphine, one of three FDA-approved medications to treat opioid use disorder. Physicians, and now nurse practitioners and physicians’ assistants, must go through an extensive process with eight-to-24 hours of training in order to prescribe this highly effective treatment. Meanwhile, as discussed above, absolutely no training is required to prescribe opioids which killed 42,249 Americans in 2016 alone. Furthermore, nowhere else in medicine is such a stringent requirement placed on physicians to prescribe a highly-effective, FDA-approved treatment for patients. Granted, providers should be educated on MAT prescribing to ensure drugs are prescribed as part of a comprehensive plan for recovery including counseling services. Furthermore, appropriate safeguards must be in place to prevent diversion of MAT drugs to non-opioid addicted individuals. However, if a lengthy training is a barrier to physicians obtaining waivers, this requirement should be revisited by policymakers.
One amendment filed for yesterday’s Senate Finance Committee markup by Senators Tom Carper (D-DE) and Bill Nelson (D-FL) would require CMS to examine financial, administrative, statutory and regulatory barriers to increasing MAT training among health care providers. CMS would also issue recommendations to Congress on ways to eliminate such barriers and increase the number of providers trained to prescribe MAT to treat opioid addiction. The amendment noted that health care providers must currently complete eight-to-24 hours of training in order to qualify for a waiver and that applications may include a significant cost or fee that may discourage some health care providers from MAT training. The amendment also stated that health care providers are concerned that the requirements and fees associated with MAT training are repetitive, unnecessarily time-consuming, and may prevent health care providers from prescribing MAT to patients.
- Raise the patient limit on prescribing medication-assisted therapy, and study removing the limit altogether. Currently prescribers who have undergone the process and training to obtain a DEA waiver to prescribe MAT are limited to doing so for only up to 100 patients. Prescribers currently can apply for an increase in the patient limit to 275, if they have met certain requirements, and legislation pending in the House and Senate proposes making the 275-patient limit permanent by law. Legislation before Congress would also permanently allow nurse practitioners and physician assistants to treat patients with MAT drugs such as buprenorphine. These policy proposals should be supported.
However, why have a cap at all? Why tell doctors how many patients they can treat, creating further stigma and posing yet another barrier to MAT access? We don’t have patient caps for patients with other chronic diseases such as heart disease or diabetes or cancer. The Government Accountability Office (GAO) or other relevant entity should study the effects of removing the patient caps altogether. Another approach – such as in CARA 2.0 – would allow states to waive the limit on the number of patients a physician can treat with buprenorphine so long as they follow evidence-based guidelines.
As many good policy ideas move through the legislative process, we hope to see these impactful and inexpensive policy reforms included, as they could have a tremendous effect on prevention and treatment of opioid addiction in America.
KEYWORDS: 115TH CONGRESS, BILL NELSON, BRAD SCHNEIDER, CENTERS FOR MEDICARE AND MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES, DRUG ENFORCEMENT AGENCY, FOOD AND DRUG ADMINISTRATION, ROB PORTMAN, SENATE FINANCE COMMITTEE, SENATE HELP COMMITTEE, SHELDON WHITEHOUSE, SUSAN BROOKS, TOM CARPER