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Latest Spike in Prescription Drug Spending Prompts OIG Investigation

A new report released by the IMS Institute for Healthcare Informatics shows that U.S. spending on pharmaceuticals increased in 2014 by 13.1 percent, reaching $373.9 billion. This is the highest increase since 2001 when drug...more

Generic Drug Manufacturers to be Investigated by HHS for Recent Price Hikes

On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more

Toxic Tort and Environmental Litigation: Toxic Substances Control Act - Reform at Last? (4/15)

Efforts to reform the Toxic Substances Control Act (TSCA), 15 U.S.C. § 2601 et seq., have been underway for several years, but to date, none have succeeded in modifying how this often criticized law regulates chemicals in...more

Washington Healthcare Update

This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

Congress Holds Hearing on 340B Program

The U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Health held a hearing on March 24, 2015 to review the functionality of the 340B Drug Pricing Program to understand how it impacts patients,...more

Bringing Predictability and Speed to DEA’s Scheduling of New Drugs

A bipartisan bill working its way through Congress could have a major effect on how the Drug Enforcement Agency (DEA) classifies drugs under the Controlled Substances Act (CSA). The Improving Regulatory Transparency for New...more

Washington Healthcare Update

This Week: Bipartisan, Bicameral Permanent SGR Fix Introduced... House Budget Committee Advances FY2016 Budget Proposal... National Coverage Determinations Proposed for Removal... HHS Releases Proposed Rules on EHR Incentive...more

Washington Healthcare Update

This Week: Senate HELP Committee Hosts Hearing on Medical Innovation... HHS Announces Next Generation Accountable Care Organization (ACO) Model... CBO Releases New Long-range Cost Estimates for ACA....more

TSCA Reform: Detailed Analysis of Frank R. Lautenberg Chemical Safety for the 21st Century Act: Significant Changes Made to...

The Senate over the past several years has considered a number of legislative texts to amend the Toxic Substances Control Act (TSCA). These include the Safer Chemicals Act, several versions of which were introduced by Senator...more

Health Care Update - March 2015 #2

In This Issue: - Senate HELP Begins Innovation for Healthier Americans Hearings - 340B Hearing Postponed; Written Testimonies Shed Light on Agenda - Implementation of the Affordable Care Act -...more

White House Releases Cyber Threat Intelligence Integration Center Fact Sheet

On February 25, the White House issued a fact sheet regarding the establishment of the Cyber Threat Intelligence Integration Center (CTIIC), which outlines the purpose, authority, organizational structure, and how the CTIIC...more

New Cyber Agency to Combat Cyber Threats

The Obama administration, on February 10, announced its intention to create a new federal agency to combat cyber threats and coordinate digital intelligence among all federal agencies....more

Washington Healthcare Update

This Week: Ways and Means Advances Four Health-Related Measures... Senate Commerce Committee Clears Legislation on E-Cigarette Packaging... CMS Pushes Back Deadline on Meaningful Use for Physicians....more

Executive order "promoting private sector cybersecurity information sharing": top points

In conjunction with the recent White House Summit on Cybersecurity and Consumer Protection Summit, President Barack Obama has issued a much-anticipated cybersecurity information sharing Executive Order, "Promoting Private...more

White House Unveils New Federal Cybersecurity Agency

On February 10, the White House announced it will establish the Cyber Threat Intelligence Integration Center (CTIIC). In prepared remarks, Lisa Monaco, Assistant to the President for Homeland Security and Counterrorism,...more

Cybersecurity Executive Order: Not Much New

President Obama’s February 13 Executive Order, “Promoting Private Sector Cybersecurity Information Sharing” (the “EO”), turns out to be light on new measures to improve cybersecurity, but focused heavily on adjustments to...more

White House Creates New Federal Agency To Combat Cyber-Threats

The White House, on February 10, 2015, announced the creation of a new federal agency, the Cyber Threat and Intelligence Integration Center (“CTIIC” or the “Center”), to combat cyber-threats by coordinating digital...more

FDA Commisioner Hamburg to Step Down: Ostroff Acting Until New Commissioner Named

On February 5, FDA announced that FDA Commissioner Margaret Hamburg, M.D. has reportedly informed agency colleagues via en e-mail that she will step down as Commissioner at the end of March 2015. ...more

A UAS On Capitol Hill: Cleared For Takeoff?

On January 21, 2015 the U.S. House of Representatives Committee on Science, Space, and Technology's Subcommittee on Space met to discuss UAS Research and Development (R&D). ...more

Details Emerge for President’s Precision Medicine Initiative

Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more

Two New Laws Give DHS Increased Cybersecurity Authority

Two recently enacted laws give the Department of Homeland Security (DHS) increased authority and ability to contain cybersecurity threats and breaches. Congress passed both the Federal Information Security Modernization Act...more

Annual Compensations Must Be Posted by Local Government Agencies in California

Law That Takes Effect Jan. 1 Requires Sharing Public Employee Pay Information Online - Starting Jan. 1, local public agencies will be required to post information on the annual compensation of their elected officials,...more

President Obama Signs Several Bills Aimed at Cybersecurity

On December 18, 2014, President Barack Obama signed several significant cybersecurity bills into law. These bills include the Federal Information Security Modernization Act, the Border Patrol Agent Pay Reform Act, the...more

Congress Confirms NIST’s Role in Cybersecurity – and the Continuation of the Cybersecurity Framework

The Cybersecurity Enhancement Act of 2014 (CEA) was passed by the House and the Senate on December 11th, and signed by the President on the 18th. The bill formalizes the role of the National Institute for Standards and...more

Congress Passes the National Cybersecurity Protection Act: Codifies National Cybersecurity Center & Creates Federal Agency Data...

The National Cybersecurity Protection Act of 2014 (NCPA) was passed by the House on December 8th, by the Senate on December 10th, and signed by the President on December 18th. Senate Committee on Homeland Security and...more

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