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February 13, 2020 | Daily News

In March, FDA’s newly established Controlled Substances Program will launch its Opioid Data Warehouse, which will allow the agency to integrate diverse data sources and enhance data analysis to pinpoint trends and new developments in the opioid crisis, FDA Deputy Center Director for Regulatory Programs Doug Throckmorton said Wednesday (Feb. 12).

February 10, 2020 | Daily News

The Trump administration’s proposed 2021 budget unveiled Monday (Feb. 10) would exempt qualified residential treatment programs from a restriction that prevents Medicaid from paying for inpatient stays in certain large facilities.

February 07, 2020 | Daily News

A leading telehealth company and health plans suggest closing the gap on access to mental and behavioral health services is a top priority for virtual care in 2020 as they continue to adjust telehealth services to consumers’ needs and push lawmakers to pass legislation expanding access to such services.

February 05, 2020 | Daily News

The 2021 Medicare Advantage and Part D proposed rule released Wednesday (Feb. 5) seeks to implement several new policies aimed at reducing opioid abuse in Medicare, including requiring Part D plans to establish drug management programs that would limit a beneficiary’s access to opioids if the beneficiary were deemed to be at risk of abuse.

February 05, 2020 | Daily News

The House Oversight & Reform Committee is already probing the Trump administration’s national drug strategy that was released Monday (Feb. 4), continuing the work of the late Chair Elijah Cummings (D-MD) who last year questioned the White House Office of National Drug Control Policy (ONDCP) on what he called an inadequate strategy.

January 30, 2020 | Daily News

The House Energy & Commerce health subcommittee on Wednesday (Jan. 29) discussed several legislative proposals that aim to reform drug manufacturing, update generic drug labels and increase FDA’s authorities over imported medical devices.

January 30, 2020 | Daily News

Advocates for non-opioid pain management alternatives are calling on policymakers to increase access to non-opioid pain management alternatives, including unbundling certain drugs in outpatient settings and increasing provider training.

January 30, 2020 | Daily News

Advocates for non-opioid pain management alternatives are calling on policymakers to increase access to non-opioid pain management alternatives, including unbundling certain drugs in outpatient settings and increasing provider training.

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.