Today, the House Energy and Commerce Committee Health Subcommittee held the first day of a two day hearing on 25 bills to address the opioid misuse and overdose epidemic.
Two panels of witnesses testified at today’s hearing and included:
- Dr. Scott Gottlieb, Commissioner, Food and Drug Administration (FDA)
- Dr. Anne Schuchat, Acting Director, Centers for Disease Control and Prevention (CDC)
- Dr. Christopher Jones, Director of the National Mental Health and Substance Use Policy Laboratory, Substance Abuse and Mental Health Services Administration (SAMHSA)
- Sue Thau, Public Policy Consultant, Community Anti-Drug Coalitions of America (CADCA)
- Cartier Esham, Emerging Companies, Biotechnology Innovation Organization
- Jeffrey Francer, Senior Vice President and General Counsel, Association for Accessible Medicines
- Dr. John Holaday, Chairman, Co-Founder and CEO, DisposeRx
A list of the bills being considered by the Committee and full witness statements are available here.
Some of the key issues touched upon during the 5-hour hearing are summarized below. In terms of process, as referenced above, the Committee will hold Day 2 of the hearing tomorrow. Today/tomorrow’s hearing mark the second of three hearings the Committee will hold on the opioid misuse and overdose epidemic. The third hearing on Medicare, Medicaid and payer issues is expected to be held in April. Chairman Walden (R-OR) has said he wants the Committee to complete consideration of bills to address the opioid misuse and overdose epidemic by Memorial Day.
On the Senate side, the Senate Health, Education, Labor and Pensions (HELP) Committee had hoped to begin considering legislation this week ahead of the 2-weeks Easter break, but a markup will now not occur until April at the earliest. The Committee may hold a legislative hearing on April 11th after the recess.
Key Issues Covered Today at Energy and Commerce
21st Century Cures Funds
Subcommittee Chairman Burgess (R-TX) and Rep. DeGette (D-CO) asked Dr. Jones with SAMSHA about reports that the states have not spent all of the money allocated by the 21st Century Cures Act to address the opioid misuse and overdose epidemic. Dr. Jones responded that the funds were distributed May 1st and any bottlenecks are at the state level due to variations in the state procurement process and contracting with providers.
Burgess asked Jones if SAMHSA would commit to working with Members who feel their states are not getting the money and Jones said yes and that SAMSHA has put in place technical assistance to assist the states.
Neonatal Abstinence Syndrome
Dr. Burgess, an OB/GYN by training, noted Dr. Schuchat’s testimony that about 100 babies are born daily with neonatal abstinence syndrome (NAS) and asked about efforts to address this. He added that for every baby born with NAS there is a mother who may also have a problem and said that the increases in maternal mortality rates in the US may be related to opioids. Dr. Jones responded that a comprehensive approach is needed and noted that some mothers may have been prescribed opioids while others may be misusing them. When Burgess pressed him if the response has been commiserate to scope of the problem, Jones stated, “I certainly think that we are trying to put out money as quickly as possible and to help advance evidence-based practices. The magnitude of the issue, as Dr. Schuchat mentioned, continues to grow and we need to make sure that resources are commensurate with the skill of the problem.” Burgess thanked Jones for his response, but seemed somewhat unsatisfied and said further discussions may be needed.
Recovery Supports/HR 5237
Subcommittee Ranking Member Green (D-TX) referenced legislation he recently introduced with Rep. Guthrie (R-KY), HR 5327, which would establish grants to create comprehensive opioids recovery centers. He asked Dr. Jones if he believes connectivity is important. Dr. Jones said yes, stating “As a person in long-term recovery from opioid addiction, I'm very familiar with navigating the fragmented system, and so providing that is sort of a one-stop shop, I think really sets people up for success. And we need to make sure they have access to evidence-based care like medication-assisted treatment, like housing support, employment, other -- other supports to really make them successful in the long run is very important.”
Rep. Guthrie said that SAMHSA data released in Health Affairs found that fewer than 3% of treatment centers are able to offer all 3 FDA-approved medications for the treatment of substance use disorders and asked if the current system is offering the full range of treatments. Dr. Jones responded that the regulatory scheme around each of the FDA-approved Medication Assisted Treatments (MAT) may be why not all providers offer each drug, but that a system should be built so patients have access to the treatment that is most appropriate to them and if the provider they are seeing does not offer one of the drugs, they should be able to refer the patient to a provider who does.
Guthrie also referenced the importance of job training and said that 1/3 of individuals who are not working have been prescribed opioids.
Following testimony by the second panel, Rep. Guthrie asked Ms. Esham about the barriers to patient-centered care. She responded that there are payer practices such as fail first and step therapies that limit access to non-opioid pain treatments.
Prescription Drug Monitoring Programs (PDMPs)
Full Committee Chairman Walden (R-OR) asked about barriers to PDMPs in clinical workflow and Dr. Schuchat responded that progress is being made in states that have incorporated their PDMPs into electronic health records (EHRs). She said that in order for PDMPs to be successful they have to be easy for the physician to use. She added that PDPMPs can be particularly useful when linked to public health data in order to find “hot spots” or prescribers who are operating at extreme levels of prescribing and inter-state operability is another goal to maximize their usefulness.
Patient Privacy Protections
Chairman Walden and Rep. Mullin (R-OK) asked Dr. Jones about 42 CFR Part 2 privacy protections. Since Rep. Murphy (R-PA) resigned, Mullin has become the lead sponsor of HR 3445, the Overdose Prevention and Patient Safety Act, which would amend 42 CFR Part 2.
Walden asked Dr. Jones about the outcome of SAMHSA’s recent listening sessions on 42 CFR Part 2 and Mullin noted he had received a letter from SAMHSA supportive of aligning Part 2 more closely with HIPAA.
Dr. Jones said that at the listening sessions, they heard a recognition that Part 2 itself may be stigmatizing because it separates substance use history from the rest of a patient’s medical record. He stated, “From the listening session, I think it was -- again, there's -- there's passion on -- on this issue across the spectrum. But I think there was a consistent recognition that -- from the stakeholders that Part 2 may in and of itself -- the constraints around treating information differently may in and of itself be stigmatizing; sort of reinforcing the idea that people who have addiction or substance use disorders should be treated unfairly.”
Jones also said that he is encouraged that Congress is looking at Part 2 as SAMHSA feels they have gone as far as they can under their existing regulatory authorities.
Rep. Walberg (R-MI) raised Jessie’s Law, which allows a patient to add their substance use disorder history to their medical record. Jones said that that would be a complement to what the Department is trying to do, but thought needs to be given to how this is done because just giving the provider the information without telling them what to do about it will not help. Walberg seemed confused and asked why a doctor would not prescribe accordingly if the information on a patient’s substance use history is available. Dr. Jones responded that no, it is not correct to assume that a doctor knows how to prescribe to someone with a substance use disorder and gave an example from his own life of a doctor wanting to prescribe an opioid to him when he had a colonoscopy.
Dr. Gottlieb said that part of what created the opioid misuse and overdose epidemic was a change in prescribing patterns and said that FDA has taken steps and is looking at additional ways to limit prescribing. For example, he said they are looking at if packaging opioids in blister packs of 3 – 5 day doses would limit prescriptions (versus 30 day bottles).
A few Members, including Reps. Shimkus (R-IL) and Carter (R-GA), cautioned that they would want to make sure people with chronic pain and hospice patients are still able to access their medications.
Rep. Bilirakis (R-FL) asked why the CDC prescribing guidelines did not work. Dr. Schuchat responded that they are seeing a decline in opioid prescriptions, but the prescribing rate is still too high. She noted that the death rates are up because of fentanyl.
Rep. Brooks (R-IN) referenced a draft bill she is working on to require prescribers to have 3 hours of education, including on how to identify a substance use disorder. She asked the second panel if that would be reasonable. Mr. Francer with the Association for Accessible Medicines said that it would seem reasonable to require three hours linked to a DEA license given the risk associated with opioid products.
Mental Health and Substance Use Parity
Rep. Kennedy (D-MA) asked about enforcement and implementation of the Mental Health Parity and Addiction Equity Act (MHPAEA). Dr. Jones responded that parity is critical and SAMHSA has been working with the other Agencies to issue the guidance dictated by the 21st Century Cures Act. Kennedy asked if there is sufficient enforcement of violations and Jones said he would have to defer to the other agencies with enforcement authority, but they have been issuing FAQs and tools for health plans on what constitutes a violation of the law.
Availability of Treatment/Infrastructure
Rep. Schakowsky (D-IL) referenced a recent visit she made to an opioid detoxification facility and said she is concerned there are not enough treatment programs for patients after detox and long waiting lists for treatment.
Dr. Jones said that there needs to be a move away from the idea that more beds are needed as the vast majority of people can be treated in an outpatient setting. He said beds should be available for those who need them and cited the example of an individual with a co-occurring serious mental illness as needing to be treated in an inpatient setting.
Schakowsky said that it’s “obvious” what needs to be done – more beds for detox and more outpatient treatment availability and asked why that is not happening. Jones said that the dollars from the 21st Century Cures Act are trying to build that capacity to provide treatment on demand. He added that it should be clear that detox by itself is not treatment and there needs to be a connection to ongoing care. He also noted that they are making investments in the workforce.
Jones closed his remarks to Congresswoman Schakowsky by stating that people are at high risk of dying if they are on a waiting list.
Rep. Bilirakis also asked Dr. Schuchat what should be done to increase access to treatment and she said some authorities to address the workforce – such as direct hiring authority and loan repayment for providers who treat specific populations – would be helpful.
During the second panel, Sue Thau from CADCA noted that a sustainable infrastructure is needed to address all types of substance use. She noted that during an increase in methamphetamine use, Congress appropriated more dollars to address it, but then the funds disappeared once the rates of abuse lowered.
Evidence Based Treatment/Results Act
Rep. Engel (D-NY) noted that he recently introduced the Results Act with Rep. Stivers (R-OH) and said the goal of the bill is ensure federal funds are used for practices that are backed by sound evidence. He asked Dr. Jones about what types of tools will be made public when the policy lab created by the 21st Century Cures Act is fully operational.
Dr. Jones said he is in the process of setting up a new resource center within SAMHSA helmed by the policy lab. He said that they are going through resources that already exist and are trying develop websites that will allow a broad spectrum of individuals – from laypeople to experts – to access resources, some of which have been previously buried on the SAMHSA website, easily by topic.
He added that SAMHSA is trying to drive innovation by engaging with states and using funding to drive evidence based practices via funding streams.
Safe Disposal and Storage of Opioids
During the second panel, Dr. John Holaday from DisposeRx showed how their product works by mixing pills with water and his company’s substance which turns the pills into an inert gel. Holaday noted that child safety locks existed for medications but were rarely used until mandated by Congress and said similar steps should be taken to limit access to and subsequent misuse of opioids.
Post Office and Mail Inspections
There was considerable discussion during the first panel of the hearing about the difficulties associated with monitoring mail coming into the country and the amount of illicit or fraudulent drugs that are being shipped in.
As noted above, tomorrow the Committee will hold the second day of the hearing. We will send you a summary after the hearing concludes.
|Katie Weyforth Vanlandingham
Van Scoyoc Associates