Last week, there were developments in federal actions related to prevention, treatment and enforcement related to opioids. The AAHKS advocacy firm, Epstein Becker & Green, has prepared a synopsis of these activities including the White House Opioid Summit, a bipartisan bill introduced in the U.S. Senate and a hearing by the House Energy and Commerce Committee. Here is the full analysis of how the actions apply to physicians and their practices:
The White House
On March 1, 2018, the White House hosted an Opioid Summit attended by individuals who are affected by the opioid crisis, as well as addiction and recovery-focused organizations, in order to highlight current and future initiatives. The event consisted of two panels: Prevention, Treatment, and Recovery; and Law Enforcement and Interdiction. The President announced that the Justice Department has created a new task force entitled the Prescription Interdiction & Litigation (PIL) Task Force that will focus on litigating against opioid manufacturers and distributors who have contributed to the epidemic. The President said that the Administration will be rolling out additional policies over the next three weeks.
On February 27, 2018, a group of bipartisan senators introduced a supplemental bill to the Comprehensive Addiction and Recovery Act (CARA) signed into law in 2016. The legislation, also known as CARA 2.0, would permanently allow physician assistants and nurse practitioners to:
- Prescribe buprenorphine with guidance from a qualified physician
- Allow states to waive the cap on how many patients to whom each doctor can prescribe buprenorphine
- Increase civil and criminal penalties for opioid manufacturers if they fail to report suspicious orders or do not do enough to prevent diversion
- Establish a three-day limit on initial opioid prescriptions for acute pain, with exceptions for chronic pain or pain for other ongoing illnesses
- Require physicians and pharmacists to use their state prescription drug monitoring program before prescribing or dispending opioids.
The bill allocates $1 billion to implement these measures.
House of Representatives
On February 28, 2018, the House Energy and Commerce Committee conducted a hearing entitled “Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety,” which is one of the three scheduled hearings addressing the opioid crisis. The hearing reviewed eight legislative proposals that involve the Controlled Substances Act:
H.R. 5041, the Safe Disposal of Unused Medication Act, authored by Reps. Tim Walberg (R-MI) and Debbie Dingell (D-MI), will help 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.
H.R. __, the Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018, a discussion draft written by Reps. Ryan Costello (R-PA) and Rick Nolan (D-MN) will make long updates in federal law to improve dispensing of implantable and injectable therapies – developed to make abuse, misuse, and diversion more difficult.
H.R. __, the Special Registration for Telemedicine Clarification Act of 2018, a discussion draft written by Reps. Buddy Carter (R-GA) and Cheri Bustos (D-IL) will clarify telemedicine waivers. Federal law permits the Attorney General to issue a special registration to health care providers to prescribe controlled substances via telemedicine in legitimate emergency situations, such as a lack of access to an in-person specialist. Unfortunately, the waiver process has never been implemented through regulation, and some patients do not have the emergency access they need to treatment. This draft directs the Attorney General, with the Secretary of Health and Human Services, to promulgate interim final regulations within 30 days of passage of the law.
H.R. __, the Improving Access to Remote Behavioral Health Treatment Act of 2018, a discussion draft written by Reps. Gregg Harper (R-MS) and Doris Matsui (D-CA) will expand access for patients in rural and underserved communities who may live near community mental health or addiction treatment centers, but not a hospital or state-licensed clinic. Without a DEA registration these health facilities do not qualify for the Ryan Haight Act’s telemedicine exception, and are unable to provide care to patients in need. This proposal would direct the Attorney General, with the Secretary of Health and Human Services, to promulgate interim final regulations within 120 days of passage of the law for these treatment facilities to register with the DEA to engage in the practice of telemedicine.
H.R. __, the Tableting and Encapsulating Machine Regulation Act of 2018, authored by Rep. David Kustoff (R-TN), will make it tougher to traffic synthetic drugs. This bill will give the DEA the authority to regulate the use of tableting and encapsulating machines with requirements for the maintenance of records, inspections for verifying location and stated use, and security provisions.
H.R. 2063, the Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017, authored by Rep. 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.
H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act, authored by Reps. Mark DeSaulnier (D-CA) and Buddy Carter (R-GA), will help pharmacists detect fraudulent prescriptions. H.R. 4275 will help develop and disseminate materials, giving pharmacists greater understanding and ability to decline to fill controlled substances when they suspect the prescriptions are fraudulent, forged, or appear to be for abuse or diversion.