Substance Abuse

News & Analysis as of

21st Century Cures: A Closer Look

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

SAMHSA Releases Final and Supplemental Proposed Rules on Substance Abuse Records Privacy Protections

A new Substance Abuse and Mental Health Services Administration (SAMHSA) final rule is intended to modernize federal regulations governing the confidentiality of substance abuse records. SAMHSA explains in the preamble that...more

The 21st Century Cures Act

Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more

21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries

The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...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

Landmark Mental Health Bill Creates Unique Opportunity for Connecticut Providers

Something refreshing actually came out of the U.S. Congress last week. In a rare display of bipartisanship, the Senate voted 94 to 5 to pass the 21st Century Cures Act, which is being called the most comprehensive mental...more

Major Mental Illness, Substance Use Disorder Reforms, Opioid Abuse Treatment Funding Included in 21st Century Cures Act

Advocates have been pushing hard over the past couple of years for the reform and expansion of mental illness and substance use disorder (i.e., behavioral health) treatment in the U.S. The 21st Century Cures Act — which has...more

U.S. Surgeon General Issues Comprehensive Report on Addiction and Substance Misuse in America, Calls for Increased Treatment in...

On November 17, 2016, the U.S. Surgeon General released a comprehensive report on addiction, substance misuse, and substance use disorders. The Surgeon General’s Report on Alcohol, Drugs, and Health is considered a landmark...more

21st Century Cures Act Includes Prohibition on Information Blocking and Mandates for Additional HIPAA Guidance

On November 30, 2016, the U.S. House of Representatives voted strongly in favor of the 21st Century Cures Act (the Act), an expansive health bill that addresses the discovery and development of new medical therapies as well...more

Pharmacy Drug Take-Back Programs Get Green Light in California

On October 26, 2016, the California Board of Pharmacy adopted regulations largely tracking the federal Drug Enforcement Administration’s program encouraging pharmacies to voluntarily collect and dispose of unwanted, unused or...more

Price hikes and product hype: Big Pharma’s relentless push

Just how rapacious can Big Pharma be? Makers hype more drugs as nation faces opioid drug abuse epidemic - In the face of an epidemic of opioid painkiller abuse, the drug industry’s answer appears to be: push even...more

You Should Know - October 2016

“You Should Know” Risk and Prevention Guide - Opiate Drug Abuse, Deaths Soar Along with Drug Company Profits - In April, musician and icon Prince died in his home from an accidental overdose of the prescription...more

Public Health Bills Advance

On September 30, 2016, President Obama signed into law S 1878, the Advancing Hope Act, which modifies the FDA’s priority review voucher program for rare pediatric diseases and extends the program through December 31, 2016. In...more

SAMHSA Final Rule on Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements

On September 27, 2016, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a final rule establishing annual reporting requirements for certain practitioners who prescribe buprenorphine-based...more

Ugly details emerge on how Big Pharma fueled painkiller scourge

New information has surfaced about Big Pharma’s relentless campaign to sell the public on prescription, opioid painkillers-powerful, addictive drugs whose wide availability and abuse now has become a killer scourge that...more

Massachusetts Hospital Licensing Regulations Proposed Amendments – Key Take-Aways

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Hospital Licensure Regulations (105 CMR 130.00) (the “regulations”). The proposed amendments are designed to...more

UnitedHealth Plan Holders Win Class Certification in ERISA Lawsuit

The District Court for the Northern District of California recently granted certain members of UnitedHealth health plans class certification in their suit alleging improper denial of benefits. Plaintiffs in the putative...more

Drug Treatment Centers Must Walk a Fine Line With Respect to Marketing

A recent New York Times article entitled “How Staten Island’s Drug Problem Made It a Target for Poaching Patients,” details how recruiters for treatment centers as near as Long Island and upstate New York, and as far away as...more

Manatt on Health Reform: Weekly Highlights - August 2016 #3

CMS’s risk adjustment program data signals an improving risk pool while the agency announces plans to modify the program; California enrolls 134,000 undocumented immigrant children into Medicaid; and Oregon approves increases...more

Joint Custody and Legal Decision Making

In Hull v. Wesley the Division One of the Arizona Court of Appeals addressed legal decision-making for children in the context of pain medication. These medications were taken during the pregnancy. The child was born...more

Obama Administration, Congress Take Steps to Fight Opioid Epidemic

HHS has announced a series of actions to address the nation’s opioid epidemic, as Congress has cleared the Comprehensive Addiction and Recovery Act for the President’s signature. As part of the HHS activities, the Substance...more

House of Representatives Approves Mental Health System Reform Bill

The House of Representative has overwhelmingly approved a bipartisan bill (H.R. 2646, the Helping Families in Mental Health Crisis Act) to reform the nation’s mental health care system. Key provisions of the legislation...more

Addressing the Opioid Crisis

Following the July 13 U.S. Senate's passage of Comprehensive Addiction and Recovery Act (CARA), providers, families and communities should evaluate the act's impacts. The reform, S. 524, is viewed as a comprehensive approach...more

In the Line at Social Security, I Wonder, Have We Made It Too Easy to Quit?

One of the smartest, most perceptive persons I have ever had the good fortune to know, a gentleman from Worcester who has had a long and highly successful career in accounting and insurance, once said to me, “I’m willing to...more

FY2017 Massachusetts Budget Update: The Conference Committee Budget

Just before the close of the fiscal year, the House and Senate reached an agreement on a $39.146 billion state budget for FY17. Due to a recently identified $750 million drop in projected state revenue, the budget, which was...more

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