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Opioids

August 26, 2019 | Daily News

An Oklahoma judge determined that Johnson & Johnson and its subsidiary Janssen Pharmaceuticals played a role in the opioid crisis, and he ordered the company to pay more than $572 million based on public nuisance claims.

August 23, 2019 | Daily News

HHS’s long-awaited proposal to relax a strict privacy scheme protecting substance use records has renewed calls from both Senate and House lawmakers, including Energy & Commerce Republicans, to pass a bill going further than the proposed rule to fully align the scheme with the less-stringent Health Insurance Portability and Accountability Act (HIPAA).

August 22, 2019 | Daily News

Substance use record privacy restrictions would be loosened under a rule proposed Thursday (Aug. 22) by the Substance Abuse and Mental Health Services Administration (SAMHSA), but HHS Secretary Alex Azar said the administration is limited in fully aligning the scheme with the less-stringent Health Insurance Portability and Accountability Act (HIPAA) and would support congressional action to do so.

August 22, 2019 | Daily News

The number of Medicaid-covered prescriptions for buprenorphine, a key drug used to treat opioid addiction, increased dramatically in states that expanded Medicaid under the Affordable Care Act while remaining relatively static in non-expansion states, according to a new study from researchers at the Urban Institute.

August 21, 2019 | Daily News

CMS agreed to clarify diagnostic code requirements, assist states Medicaid agencies in correctly reporting the National Provider Identifiers (NPIs) of providers who prescribe opioids and ensure all beneficiaries can be uniquely identified in the national Medicaid claims database after an HHS Office of Inspector General (OIG) report said that national data are incomplete.

August 21, 2019 | Daily News

The White House Office of National Drug Control Policy issued advisories that explain how pharmaceutical and chemical supply companies can identify illicit fentanyl manufacturing and redistribution and prevent movement of fentanyl and other synthetic opioids into and within the United States.

August 20, 2019 | Daily News

Opioid maker Endo International’s subsidiaries, including Endo Pharmaceuticals and Par Pharmaceutical, have settled for $10 million with the plaintiffs in the ongoing multidistrict opioid litigation, the company announced Tuesday (Aug. 20).

August 20, 2019 | Daily News

FDA’s pediatric advisory committee will meet late next month to discuss the safety of opioids to manage pain in children, and to share the results of a study on the neuropsychiatric effects of an asthma drug called montelukast, more commonly known as Singulair.

August 09, 2019 | Daily News

The White House Office of Management and Budget on Friday (Aug. 9) completed its review of a proposed rule by the Substance Abuse and Mental Health Services Administration to change the privacy scheme 42 CFR Part 2.

August 08, 2019 | Daily News

State Medicaid programs soon will be required to implement stricter controls around opioid prescriptions and will also gain the option to more easily access federal money to care for beneficiaries with substance use disorders in large inpatient treatment centers.

August 08, 2019 | Daily News

An expected proposal from the Substance Abuse and Mental Health Services Administration to change 42 CFR Part 2 could be released this month, according to stakeholders who want to see the stringent privacy scheme aligned with Health Insurance Portability and Accountability Act (HIPAA).

August 06, 2019 | Daily News

The National Association of Attorneys General called on House and Senate leaders to vote on bills that would loosen the strict privacy scheme known as 42 CFR Part 2, pass legislation to remove barriers to accessing buprenorphine, and fully eliminate the Institutions for Mental Diseases (IMD) exclusion in order to expand access to medication-assisted treatment (MAT).

July 16, 2019 | Daily News

Lawmakers and federal agencies tasked with monitoring illicit drug flow, including FDA and Customs and Border Protection, pinpointed a lack of data sharing among agencies as a challenge in combating the illicit flow of fentanyl into the United States.

July 08, 2019 | Daily News

FDA is expediting review of all generic drug applications for overdose-reversal drugs, including naloxone nasal spray, injection and auto-injector, and nalmefene injection, the agency announced Monday (July 8).

July 03, 2019 | Daily News

FDA unveiled two new guides Monday (July 1) on prescription drug and biologics labeling: One focuses on labeling of drugs and biologics that have potential for abuse and dependence, and the other addresses the content and format for the instructions for use section of labeling for drugs and biologics, and drug-device or biologic-device combination products.

June 27, 2019 | Daily News

Providers and plans are optimistic that legislation to align the strict privacy scheme for substance abuse treatment records, 42 CFR Part 2, with the less-stringent Health Insurance Portability and Accountability Act (HIPAA) have a better chance of success after the American Medical Association opted to throw its support behind amending the privacy scheme and support from lawmakers has increased.

June 20, 2019 | Daily News

FDA wants to hear from stakeholders on whether new preapproval incentives are needed to encourage development of safer pain and addiction therapies at a public hearing slated for Sept. 17.

June 20, 2019 | Daily News

FDA will take into account a proposed opioid’s broader public health effects, including on non-users, and look at how the product compares in safety and effectiveness to already-approved analgesics when making future approval decisions, the agency revealed in a draft guidance published Thursday (June 20).

June 13, 2019 | Daily News

As part of their investigation into the dangers of illicit fentanyl, much of which comes from China, a bipartisan group of House Energy & Commerce Committee leaders wrote to FDA Acting Commissioner Ned Sharpless and heads of five other federal agencies to request briefings on the effect the opioid epidemic is having on public health and on their solutions for stopping the flow of illicit fentanyl into the United States.

June 12, 2019 | Daily News

CMS Administrator Seema Verma and senior advisor to the president Kellyanne Conway touted efforts by CMS and the Trump administration to improve maternal health in rural areas by extending Medicaid coverage for postpartum women with substance use disorders, but advocates said Medicaid coverage should be extended for all postpartum women and more states should expand Medicaid, speaking at a Kaiser Family Foundation event Wednesday (June 12).

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