FDA to Require Supply of Mail-back Envelopes for Outpatient-dispensed Opioids

Examination of In-home Disposal Products also Planned; Notes on New DEA Registration Requirements On April 3, 2023, the U.S. Food and Drug Administration announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings (which includes home hospice care) to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional…

CDC Proposes Updates to Controversial 2016 Opioid Prescribing Guidelines

On February 10, 2022, the Centers for Disease Control and Prevention (CDC) issued new proposed guidelines for prescribing of opioids for acute, sub-acute and chronic pain. The clinical practice guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic Pain— United States, 2016, and provides evidence-based recommendations for clinicians who provide pain care, including those prescribing opioids, for outpatients age 18 years and older with acute pain (duration less than 1 month), subacute pain (duration of 1–3 months), or chronic pain (duration of 3 months or more).

The guideline explicitly EXCLUDES sickle cell disease-related pain management, cancer pain treatment, palliative care, and end-of-life care.

The clinical practice guideline includes recommendations for primary care clinicians (including physicians, nurse practitioners, and physician assistants) as well as for outpatient clinicians in other specialties (including those managing dental and postsurgical pain in outpatient settings and emergency clinicians providing pain management for patients being discharged from emergency departments).

This voluntary clinical practice guideline provides recommendations and does not require mandatory compliance; and the clinical practice guideline is intended to be flexible so as to support, not supplant, clinical judgment and individualized, patient-centered decision-making.

As part of the guideline issuance, CDC is asking interested persons or organizations to submit written views, recommendations, and data. In order to be considered, written comments must be received on or before April 11, 2022.  Instructions for submitting comments and various materials are available HERE; the revised guideline and other supporting materials are located in the “Enhanced Content” box in the lower right hand corner of the page.

A major area of concern associated with the 2016 guideline was the emergence of misapplication of the guideline by various state and local governments. In 2018 the National Association for Home Care & Hospice (NAHC) was invited to testify before the House Energy & Commerce Committee regarding hospice disposal of controlled substances.

As part of his testimony, NAHC’s representative Dr. John Mulder of the Trillium Institute and Faith Hospice in Michigan, commented on the misapplication of the 2016 CDC guideline by states that have resulted in delayed treatment for pain experienced by individuals receiving palliative or hospice care. In 2019, CDC issued a Media Statement  on the 2016 guideline cautioning against:

  • Misapplication of recommendations to populations outside of the Guideline’s scope;
  • Misapplication of the Guideline’s dosage recommendation that results in hard limits or “cutting off” opioids;
  • Abrupt tapering or sudden discontinuation of opioids; and
  • Misapplication of the Guideline’s dosage recommendation to patients receiving or starting medication-assisted treatment for opioid use disorder.

These concerns, in part, led to issuance of the revised guideline that is currently under review.

CDC Proposes Updates to Controversial 2016 Opioid Prescribing Guidelines

On February 10, 2022, the Centers for Disease Control and Prevention (CDC) issued new proposed guidelines for prescribing of opioids for acute, sub-acute and chronic pain. The clinical practice guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic Pain— United States, 2016, and provides evidence-based recommendations for clinicians who provide pain care,…

CMS Schedules Listening Session on Opioid Prescriber Accountability

In October 2018, President Trump signed the SUPPORT for Patients and Communities Act into law; in doing so, he enacted sweeping legislation designed to address the nationwide scourge of opioid abuse.  Among the numerous provision of interest to the hospice community included in the new law was authority for hospices, under specific circumstances, to allow…

States Grapple with the Opioid Epidemic and Pain Management

Florida bill would make it easier to prescribe for hospice patients The opioid epidemic claims about 115 lives per day in the United States, a rate that has grown by 4000 percent since 1999. Nearly half of these opioid-related fatalities involve a prescription drug, according to the Centers for Disease Control and Prevention. In March…

CDC Clarifies Applicability of Opioid Prescribing Guidelines, Excepts End-of-Life and Palliative Care

The Centers for Disease Control has released a letter clarifying that its 2016 Guideline for Prescribing Opioids for Chronic Pain was not intended to apply to cancer treatment, palliative care, or end of life care. Recent efforts by policymakers to stem the nationwide epidemic of opioid abuse  culminated in the enactment of the 2018 SUPPORT…

Attention Home Health Clinical Staff – Key Webinar on Preventing Opioid Misuse

The Substance Abuse and Mental Health Administration (SAMSHA) is presenting an important webinar entitled “Improving Opioid Misuse Prevention Literacy Between Older Adults and Health Care Providers” on Thursday, March 28, 2019, 2:00 to 3:30 PM ET Register for this event! Research suggests that substance misuse, especially opioid misuse, is a growing public health issue within…

SUPPORT for Patients and Communities Act Opens Federal Door for Hospices to Dispose of Controlled Substances

In September 2014 the Drug Enforcement Administration (DEA) issued final regulations implementing the Secure and Responsible Drug Disposal Act of 2010   in which the agency clarified  (for the firs time) that hospices were prohibited from disposing or assisting in the disposal of controlled substances for hospice patients unless there was a state law granting authority…

SUPPORT for Patients and Communities Act Opens Federal Door for Hospices to Dispose of Controlled Substances

In September 2014 the Drug Enforcement Administration (DEA) issued final regulations implementing the Secure and Responsible Drug Disposal Act of 2010   in which the agency clarified  (for the firs time) that hospices were prohibited from disposing or assisting in the disposal of controlled substances for hospice patients unless there was a state law granting authority…

NAHC Applauds Passage of Key Legislation to Curb Opioid Epidemic

The National Association for Home Care & Hospice (NAHC) commends the United States Senate for passing The SUPPORT for Patients and Communities Act, a bipartisan bill which contains a wide array of initiatives to address America’s overwhelming opioid crisis. The bill now heads to President Donald J. Trump for his signature. Among the many provisions…