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HPE Miami 2021: Subsector Insights - Pharmacy

New therapies and the accompanying technologies to deliver them make pharmacy an appealing space for investment in 2021. In particular, organizations that can find ways to effectively manage escalating costs will be...more

DEA Proposes Regulations for Emergency Medical Services Agencies

On October 5, 2020, the US Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking establishing a registration category for emergency medical services (EMS) agencies and more generally implementing the...more

DEA Provides Additional Guidance Regarding Prescription and Other Policies During the COVID-19 Public Health Emergency

To assist healthcare providers and others in the industry during the Coronavirus (COVID-19) pandemic, the US Drug Enforcement Agency (DEA) has issued guidance addressing specific areas of concern, including practitioner...more

Exemptions and Considerations for the Treatment of Opioid Use Disorder During the COVID-19 Emergency

The Substance Abuse and Mental Health Services Administration (SAMHSA) has published new guidance for the care and treatment of substance use disorders during the COVID-19 outbreak. Of note, the guidance includes specific...more

DEA Initiates Rulemaking to Waive Separate Registration for Mobile NTP

On February 26, 2020, the US Drug Enforcement Administration (DEA) issued a Notice of Proposed Rule Making (NPRM), which proposes waiving the requirement of a separate DEA registration at each principal place of business or...more

DEA Proposes Reduction in US Opioid Manufacturing Quotes

On August 16, 2018, in a joint statement by the US Department of Justice and the US Drug Enforcement Administration (DEA), the government proposed a reduction in the Aggregate Production Quotas (APQ) for certain controlled...more

8/20/2018  /  DEA , Life Sciences , Opioid

DEA Publishes Proposed Rule Regarding Quota Processes

On April 19, 2018, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rule Making (NPRM) proposing various changes to DEA’s process for setting Aggregate Production Quotas (APQ) and Individual...more

4/23/2018  /  DEA , Proposed Rules , Quotas

DEA Reverses Previous Changes to Registration Renewal Processes

The US Department of Justice Drug Enforcement Agency (DEA) recently reversed most of the changes to its registration renewal process that were previously slated to become effective January 1, 2017. ...more

21st Century Cures: Tackling the Growing Problem of Mental Health and Substance Use Disorders

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

Ninth Circuit Considers Limits to DEA Access to Oregon PDMP

On November 7, 2016, the US Court of Appeals for the Ninth Circuit heard arguments in Oregon Prescription Drug Monitoring Program v. United States DEA, No. 14-35402 (9th Cir. 2016). Here, the Drug Enforcement Administration...more

DEA Posts Significant Change to Registration Renewal

The DEA recently posted to its website notice of a significant change to its registration renewal process. This change eliminates the informal grace period which the DEA had previously allowed registrants to renew their...more

Congress and Obama Administration Take Steps to Ease Buprenorphine Access

On Friday, July 22, President Obama signed the Comprehensive Addiction and Recovery Act of 2016 (CARA). Following on federal, state and local trends, CARA seeks to expand access for persons needing opioid treatment....more

FDA Takes Further Steps to Curb Opioid Abuse

Required Black Box Warnings on Immediate Release Opioids - Closely following on recent efforts undertaken by states and the Centers for Disease Control to curb opioid abuse (review further here and here), the U.S. Food...more

CDC Issues New Guidelines for Opioid Painkiller Prescriptions

In response to a significant increase in opioid overdose deaths, the U.S. Centers for Disease Control and Prevention (CDC) released new guidelines [today] regarding prescriptions for opioid painkillers. The CDC notes...more

Massachusetts Adopts Comprehensive Legislation To Curb Opioid Abuse

On March 14, 2016, Massachusetts Governor Charlie Baker signed comprehensive legislation designed to curb opioid addiction. The legislation reflects growing concern for the “dangers in the medicine cabinet” (i.e., risks...more

OIG Calls for CMS to Reform Payment for Skilled Nursing Facility Services

The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued a report on September 30, 2015, that calls for the Centers for Medicare and Medicaid Services (CMS) to reform payment for...more

FDA Announces Delay in Enforcing DSCSA Requirements for Dispensers

On June 30, 2015, the U.S. Food and Drug Administration (FDA) announced its intention to exercise its enforcement discretion to delay until November 1, 2015, its enforcement of drug product “track and trace” requirements...more

CMS Issues Proposed - Skilled Nursing Facility Rule

On April 15, 2015, Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to address Skilled Nursing Facility (SNF) Medicare rate increases for fiscal year (FY) 2016, as well as to propose a variety of measures...more

Skilled Nursing Facilities: Steps for Reducing FCA Liability

Several government agencies have voiced concerns related to the level of therapy services necessary to care for residents of Skilled Nursing Facilities (SNFs). The level of therapy services indicated for SNF residents...more

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