CDC Releases Updated Practice Guideline for Prescribing Opioids for Pain

On November 4th, the Centers for Disease Control and Prevention (CDC) released updated guidelines for prescribing opioids for adult patients. The CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022 includes twelve voluntary recommendations to help clinicians determine whether to initiate opioids for pain, select opioids and determine opioid dosages, decide the duration of initial opioid prescription and conduct follow-up, and assess risk and address potential harms of opioid use. In a change from the 2016 guidelines, CDC will no longer suggest three-day limits on opioid treatments for acute pain or propose that doctors avoid opioid dosage increases that are equivalent to 90 milligrams of morphine per day, and instead offers recommendations that support individualized patient care. The 2022 guidelines also recommends that providers consider the benefits and risks of starting, increasing, and stopping opioid treatments to prevent harm to patients experiencing severe pain, offers additional options for treating acute pain, and provides guidance for providers on opioid tapering. Following concerns that the 2016 guidelines were misapplied, CDC included an emphasis that the 2022 recommendations are voluntary and that providers should consider a patient’s need individualized care. In a press release, Dr. Christopher Jones, acting director for the National Center for Injury Prevention and Control, said “Patients with pain should receive compassionate, safe, and effective pain care. We want clinicians and patients to have the information they need to weigh the benefits of different approaches to pain care, with the goal of helping people reduce their pain and improve their quality of life.”

Articles & Resources

CDC – CDC Releases UPDATED Clinical Practice Guideline for Prescribing Opioids for Pain

CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022

CMS to Expand Medicare Coverage to Include Opioid Treatment and Recovery Services via Telehealth

On November 1st, the Centers for Medicare & Medicaid Services (CMS) published their final rule, Calendar Year 2023 Physician Fee Schedule (PFS) rule, which includes expanded Medicare coverage for opioid treatment and recovery services. Under the final rule, Medicare will cover opioid treatment and recovery services delivered through mobile units and telehealth, including programs that initiate treatments with buprenorphine using telehealth, and will reimburse clinical psychologists and licensed clinical social workers who deliver integrated behavioral health as part of a patient’s primary care team. The final rule also addresses pricing by increasing payments for medication-assisted treatment and other treatments for opioid use disorders by changing the payment rate base from a 30-minute session to a 45-minute session. In a press release, CMS Administrator Chiquita Brooks-LaSure said, “Access to services promoting behavioral health, wellness, and whole-person care is key to helping people achieve the best health possible. The Physician Fee Schedule final rule ensures that the people we serve will experience coordinated care and that they have access to prevention and treatment services for substance use, mental health services, crisis intervention, and pain care.”

Articles & Resources

CMS – HHS Finalizes Physician Payment Rule Strengthening Access to Behavioral Health Services and Whole-Person Care

Lawmakers Request Information from FDA on Non-Opioid Pain Treatments

Senators Roger Marshall (KS), James Lankford (OK), Shelley Moore Capito (WV), and Marsha Blackburn (TN) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf urging the agency to prioritize new drug and device applications for non-opioid therapies for the treatment of pain and to help patients suffering from substance use disorder. The lawmakers note that FDA developed industry guidance in February to spur innovation on non-opioid therapies but no new analgesic medications were approved in 2021, emphasizing that “Now is the time to provide patients with safe and effective non-opioid alternatives to prescription opioids for pain management.” The lawmakers conclude with the request that FDA facilitate Congress’s goal of executing the provisions of the SUPPORT for Patients and Communities Act by providing information on how FDA has acknowledged issues outlined by industry stakeholders on FDA-sponsor engagement, how FDA will reconsider the issue of potentially disincentivizing pharmaceutical manufacturers from developing non-opioid therapies for the indication of general or chronic pain, how FDA is working to ensure agency staff are currently enhancing and expanding communication with sponsors, if FDA has received new drug applications eligible for Fast Track, Priority Review, or Breakthrough Therapy designation for non-opioid products for pain management within the last four years and which applications received final agency action, how FDA is working with developers to provide a clear and predictable regulatory path to incentivize and encourage development of non-opioid pain treatments, how FDA is considering the risks and benefits for patients of non-opioid pain treatments given the potential public health benefit, and what FDA has done to achieve its stated goal of prioritizing the review and approval of nonopioid therapies for acute and chronic pain. The lawmakers request a response by November 9th. A copy of the letter can be found here.

Articles & Resources

Letter to FDA

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the topic. Links to relevant articles are provided below.

CMS – HHS Continues Biden-Harris Administration Progress in Promoting Health Equity in Rural Care Access Through Outpatient Hospital and Surgical Center Payment System Final Rule

Congresswoman Abigail Spanberger – Spanberger, Kelly in Bipartisan, Bicameral Letter Urge U.S. House & U.S. Senate Leaders to Bolster America’s Response to Drug Trafficking

FDA – FDA’s Overdose Prevention Framework with Dr. Marta Sokolowska

Health Affairs – US Supreme Court Delivers Much-Needed Certainty To Controlled Substances Prescribing

JAMA – New Guidance Aims to Improve Community Access to Naloxone

Lex Blog – Telemedicine Laws for Opioids and Substance Use Disorder Treatment

The Washington Post – Rahul Gupta on fentanyl and the nightmare of synthetic drugs

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

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