CDC Solicits Comments on Acute and Chronic Pain Management, Experiences

On Friday, the Centers for Disease Control and Prevention (CDC) published in the Federal Register a Request for Comment from stakeholders around their unique perspectives and experiences “with pain and pain management, including, but not limited to, the benefits and harms of opioid use.” CDC is requesting comments from all stakeholders throughout the healthcare delivery system including perspectives such as:

  • Patients with Acute or Chronic Pain
  • Patients’ Family Members or Caregivers
  • Healthcare Providers that address acute or chronic pain management.

In the Federal Register notice, CDC outlines three main areas where feedback is most valuable (across opioid pain medications, non-opioid medications, and non-pharmacologic interventions):

  • Experiences managing pain, which might include the benefits, risks, and/or harms of the pain management options listed above.
  • Experiences choosing among the pain management options listed above, including considering factors such as each option’s accessibility, cost, benefits, and/or risks.
  • Experiences getting information needed to make pain management decisions.

Public comments will be accepted through June 16, 2020 on Regulations.gov.

Articles & Resources

Federal Register – Management of Acute and Chronic Pain: Request for Comment

FDA Takes Action to Broaden Access to Digital Mental Health Tools to Bridge Treatment Access

As recipients of this newsletter recognize, the confluence of the opioid epidemic with the COVID-19 pandemic have presented some daunting challenges around ensuring access to treatment, inclusive of MAT and concurrent psychosocial interventions. To help address some of the issues spurred by COVID-19 related precautions such as stay-at-home orders and quarantines, FDA announced last week with issuance of a guidance document that aims to improve availability and accessibility of two types of digital health products for mental health care:

  • Prescription digital therapeutics providing computerized cognitive behavioral therapy (CBT) for psychiatric disorders; and
  • Low-risk wellness apps designed to address mental health needs.

In particular, the prescription digital therapeutic products that have currently received FDA authorization are intended to treat, in part, substance use disorders through cognitive behavioral therapy. The guidance sets forth a temporary route for individuals with SUDs to maintain access to care and continue on a positive path forward.

The public may comment on the guidance document through Regulations.gov, although there has been no formal notice and comment period due to the public health emergency.

Articles & Resources

FDA Guidance Document – Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Faegre Drinker Insights – To Address Mental Health Amid COVID-19, FDA Looks Digital

World Economic Forum – High Anxiety Calls for Innovation in Digital Mental Health

Sixth Circuit Court Excludes Pharmacy Dispensing from Opioid MDL Bellwether

Circuit court noted that the additional claims were added too late to the filing as the plaintiffs and defendants target a November start date for the trial. To date, many of the other opioid-related trials set to begin in the coming months had omitted pharmacy defendants and focused largely on the role of manufacturers and distributors for their role in the national opioid epidemic. The removal of dispensing claims will now force plaintiffs to shift arguments back towards “distribution” and the oversight of suspicious orders of controlled substances.

Articles & Resources

Law360 – 6th Circ. Limits Opioid Claims Against Pharmacies

Cleveland.com – Appeals Court Again Rebukes Cleveland Federal Judge Over Opioid Litigation Narrowing Case Against Large Pharmacy Chains

STAT News – Pharmacy Chains Get a ‘Solid’ Victory in Opioid Litigation, But Aren’t Off The Hook Yet

What We Read Last Week

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

Articles & Resources

USA Today [by Mary Bono] – Job Loss, Anxiety, Isolation: Coronavirus Is a Prescription for More Opioid Use

Health Affairs – Once the Coronavirus Pandemic Subsids, The Opioid Epidemic Will Rage

JAMA Pharmacy and Clinical Pharmacology – Assessment of Potentially Inappropriate Prescribing of Opioid Analgesics Requiring Prior Opioid Tolerance

Brookings – The Opioid Crisis and Community-level Spillovers Onto Children’s Education

New York Times – The Upshot: Damage from OxyContin Continues to Be Revealed

Orlando Sentinel – Telehealth Plays Big Role in Coronavirus Cure

NBC Bay Area News – SJ Man Faces Murder Charge After Woman ODs on Fake Opioids

Office of National Drug Control Policy – COVID-19 Fact Sheet

DEA Newsroom – DEA Releases 2020 Drugs of Abuse Resource Guide

CDC QuickStats – Age-Adjusted Drug Overdose Death Rates, by State – United States, 2018

North Dakota Attorney General – State’s New Medicaid Fraud Unit Prosecutes First Case

U.S. Attorney for the Western District of Virginia – Meadowbrook Health Services Agrees to Pay the United States $330,000 for Violations of the Controlled Substances Act

This Week’s Calendar

We hope that everyone is remaining safe and healthy during the ongoing coronavirus pandemic.

Given the ongoing circumstances, there are no hearings or relevant events noticed at this time. At this point in time, members of the House and Senate are back in-district In the instance that there are any changes to the schedule for this week, we will make additional information available.

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