Tag Archives: Drug Enforcement Administration (DEA)

House Energy & Commerce Committee Unanimously Approves FDA Reauthorization, Public Health Bills

On June 8, 2017, the Energy and Commerce Committee voted unanimously to approve an amended version of HR 2430, the FDA Reauthorization Act (FDARA) of 2017. The bill would extend the FDA prescription drug, medical device, generic drug, and biosimilar biological product user fee programs, which are scheduled to expire at the end of September.  … Continue Reading

Energy and Commerce Committee Approves Medicaid, Public Health Bills

On November 18, 2015, the House Energy and Commerce Committee approved several public health policy bills. Two approved bills pertain to the Medicaid program: HR 3716, the Ensuring Terminated Providers Are Removed from Medicaid and CHIP Act – to implement several HHS OIG recommendations to improve CMS oversight of terminated providers and state screening of … Continue Reading

Congress Clears Controlled Substances Act Scheduling Legislation

On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President.  The legislation would amend the Controlled Substances Act (CSA) to make procedural changes intended to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s (DEA) process for scheduling … Continue Reading

Energy and Commerce Health Subcommittee Advances Mental Health, Medicaid, Synthetic Drug Legislation

On November 4, 2015, the House Energy and Commerce Health Subcommittee approved the following health policy bills: HR 2646, the Helping Families in Mental Health Crisis Act – includes a series of reforms intended to improve federal mental health research, screening, and treatment programs, some of which have met with strong opposition from House Democrats. … Continue Reading

House Approves Medicare DMEPOS Competitive Bidding, Hospital Observation, Controlled Substances, & Trauma Care Bills

Yesterday the House of Representatives approved the following health policy bills: H.R. 284, the Medicare DMEPOS Competitive Bidding Improvement Act of 2015 – which would require Medicare suppliers that bid under a DME, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program to obtain a $50,000-$100,000 bid surety bond for each competitive bidding area (CBA).  If … Continue Reading

Energy & Commerce Committee Approves Bipartisan Public Health Bills

On February 11, 2015, the House Energy and Commerce Committee approved the following bipartisan public health bills: H.R. 471, Ensuring Patient Access to Effective Drug Enforcement Act (to improve enforcement efforts regarding prescription drug diversion and abuse); H.R. 639, Improving Regulatory Transparency for New Medical Therapies Act, as amended (to amend the Controlled Substances Act to … Continue Reading

Congressional Health Policy Hearings & Markups

On January 27, 2015, the House Energy and Commerce Subcommittee on Health held a hearing on bipartisan public health legislation, including: Ensuring Patient Access to Effective Drug Enforcement Act (to improve enforcement efforts regarding prescription drug diversion and abuse); Improving Regulatory Transparency for New Medical Therapies Act (to amend the Controlled Substances Act to improve … Continue Reading

DEA Issues Final Rule on Safe, Secure Disposal of Controlled Substances

The Drug Enforcement Administration (DEA) has published a final rule to implement the Secure and Responsible Drug Disposal Act of 2010, which was intended to mitigate prescription drug abuse by providing safe and secure mechanisms for “ultimate users” to dispose of unused or unwanted pharmaceutical controlled substances. The regulations allow authorized manufacturers, distributors, reverse distributors, … Continue Reading

House Energy and Commerce Subcommittee Approves Health Bills

On May 28, 2014 the House Energy and Commerce Subcommittee on Health approved by voice vote three bipartisan public health bills: H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act,” which is intended to improve the Drug Enforcement Agency scheduling process for new FDA-approved drugs under the Controlled Substances Act and the registration process for … Continue Reading

April Congressional Hearings

Recent Congressional hearings on health policy issues include the following: House Energy and Commerce Committee hearings on the “Helping Families in Mental Health Crisis Act”; the FDA’s proposed changes to generic drug labeling; and legislation intended to improve predictability and transparency in Drug Enforcement Agency and FDA regulation (H.R. 4299, H.R. 4069, and H.R. 4250). A House … Continue Reading

GAO Assesses DEA Prescription Drug Control Efforts

The GAO has issued a report entitled "Prescription Drug Control: DEA Has Enhanced Efforts to Combat Diversion, but Could Better Assess and Report Program Results." The GAO notes that the DEA has expanded resources and targeted investigation strategies to collaborate with state and local entities and enhance the effectiveness of its drug diversion investigations. Among other things, … Continue Reading

OIG Report on Invalid Prescriber IDs on Part D Schedule II Drug Claims

The OIG has issued a report entitled “Oversight of the Prescriber Identifier Field in Prescription Drug Event Data for Schedule II Drugs." Based on an audit of Prescription Drug Event (PDE) records for Schedule II drugs, the OIG found that approximately 228,000 PDE records with invalid prescriber identifiers accounted for about $20.6 million in gross drug … Continue Reading

DEA Notice and Solicitation of Information on Dispensing of Controlled Substances to LTC Facility Residents

On June 29, 2010, the Drug Enforcement Administration (DEA) published a notice requesting public comment on whether revisions to the DEA regulations are feasible and warranted to facilitate residents of long-term care facilities to receive controlled substance medications, while adhering to the framework of the Controlled Substances Act. Comments will be accepted until August 30, … Continue Reading

DEA Issues Final Rule on Electronic Prescriptions for Controlled Substances

On March 31, 2010, the Drug Enforcement Administration (DEA) issued an interim final rule with comment period allowing practitioners to write prescriptions for controlled substances electronically and permitting pharmacies to receive, dispense, and archive these electronic prescriptions. The DEA lists a number of expected benefits to the rule. First, the policy will give pharmacies, hospitals, and … Continue Reading
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