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January 17, 2020 | Daily News

A panel of FDA advisors were split on whether FDA should approve Durect Corporation’s Posimir (SABER-bupivacaine extended-release solution) for post-surgical pain relief, touted by the company as a drug that would reduce use of opioids for at least 24 hours after surgery.

January 15, 2020 | Daily News

States want HHS and Congress to allow them to use grants aimed at curbing the opioid crisis to also tackle other drugs that are prevalent in their regions, including cocaine and methamphetamine, as lawmakers call on HHS to explain how it is responding to a rise in the use of stimulants.

January 15, 2020 | Daily News

Members of two FDA advisory committees unanimously voted 27-0 against approving Nektar Therapeutics’ oxycodegol opioid for management of chronic low back pain. During the joint committee meeting on Tuesday (Jan. 14), advisors took issue with the lack of efficacy data for broader patient populations, and they were especially disappointed that the sponsor had only conducted one phase III efficacy study.

January 14, 2020 | Daily News

House Energy & Commerce Committee Republican leaders will re-open their 2018 investigation into opioid manufacturers Insys Therapeutics, Mallinckrodt Pharmaceuticals and Purdue Pharma, and the role each company played in the opioid epidemic, lawmakers announced Tuesday (Jan. 14).

January 02, 2020 | Daily News

CMS approved a waiver allowing Indiana to use Medicaid to fund inpatient treatment for serious mental illness in late December. The state joins Vermont and the District of Columbia in using Medicaid to fund inpatient treatment in certain large facilities for both serious mental illness and substance use disorder.

December 31, 2019 | Daily News

Providers and health IT groups urge Congress to look into privacy and security implications of third-party health apps in response to calls from lawmakers on what they should include in a follow-on to the 21st Century Cures Act.

December 12, 2019 | Daily News

FDA is demanding Alkermes stop publishing a print advertisement for its extended-release naltrexone drug Vivitrol, which is used to treat opioid addiction, because the ad fails to warn fatal overdoses could occur if the treatment lapses.

December 05, 2019 | Daily News

The Congressional Budget Office estimates that House Democrats’ drug pricing bill would save half a trillion dollars in a decade, according to House Democratic leaders, and Democrats plan to use those savings to pay for additional drug research at the National Institutes of Health, additional Medicare benefits and a hodgepodge of Medicare and Medicaid policies that would lower costs for beneficiaries of those programs.

November 06, 2019 | Daily News

CMS announced Wednesday (Nov. 6) that it approved a waiver to allow District of Columbia to sidestep a restriction on using Medicaid dollars to fund inpatient treatment for substance use and mental illness.

November 01, 2019 | Daily News

CMS on Friday (Nov. 1) finalized changes to the Physician Fee Schedule that will simplify documentation and coding requirements for office visits, add a new Part B benefit for opioid treatment programs and increase pay for care management services provided to beneficiaries after they leave the hospital.

October 31, 2019 | Daily News

The Senate on Thursday (Oct. 31) passed 84-9 an FDA spending package that gives the agency $3 billion in discretionary funding, which is an $80 million increase over fiscal 2019 levels but still a far cry from the $184 million increase in the bill passed by the House in June.

October 28, 2019 | Daily News

Rep. Greg Walden (R-OR), the top Republican on the House Energy & Commerce Committee, will retire at the end of this Congress, his office announced Monday.

October 28, 2019 | Daily News

Providers and hospitals applauded a rule proposed by the Substance Abuse and Mental Health Services Administration to loosen privacy protections on substance use records but still called on SAMHSA to make the scheme, known as 42 CFR Part 2, more like the less-stringent Health Insurance Portability and Accountability Act by altering parts of the proposal.

October 16, 2019 | Daily News

Several Democratic presidential candidates, including Sens. Kamala Harris (D-CA) and Amy Klobuchar (D-MN), called for holding opioid makers accountable for their role in the opioid crisis. During the Democratic presidential debates Tuesday (Oct. 15),

September 23, 2019 | Daily News

In a brief two-page report, the Government Accountability Office highlights the potential for opioid vaccines and lays out the challenges and policy questions surrounding their development, including what standards FDA should set for clinical trials and what resources would be needed.

September 23, 2019 | Daily News

FDA wants input from stakeholders on the development of abuse-deterrent formulations (ADFs) of central nervous system stimulants, which are widely prescribed to treat attention deficit hyperactivity disorder and sometimes narcolepsy.

September 18, 2019 | Daily News

A group of medicine and public health researchers and historians are calling on an Ohio court overseeing the national multidistrict opioid litigation to ensure that any settlement guarantees full and permanent access to records that contain information about and shed light on the abuse potential and distribution patterns of opioids.

September 17, 2019 | Daily News

Mental health and substance use treatment advocates are calling on Congress to reauthorize funding for mental health clinics, remove barriers to medication-assisted treatment and allow mental health counselors to bill Medicare.

September 16, 2019 | Daily News

The Certified Community Behavioral Health Clinic demonstration program lost its funding Friday (Sept. 13) for the second time this year after a short-term extension lapsed, threatening access to medication-assisted treatment and the jobs of those who work at these clinics, according to patient advocates.

September 13, 2019 | Daily News

Plans say prior authorization for medication-assisted treatment (MAT) for individuals with substance use disorders helps the treatment be used safely and effectively, but providers are worried that prior authorization is a barrier to treatment in the middle of an opioid crisis.