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Capital Thinking: Technology and Communications

Legislative Activity - House Commerce SUBCommittees Will Hold Hearing ON 21st Century Technology for 21st Century Cures - The House Energy and Commerce Subcommittees on Communications and Technology and Health...more

Health Care Update - July 2014 #2

In This Issue: - Obama Administration Ramps up Efforts to Reduce Medicaid Spending - Senators Press Gilead on Sovaldi - Implementation of the Affordable Care Act - Other Federal Regulatory...more

Health Care Update - July 2014

In This Issue: - E&C continues to push for bipartisan efforts to improve drug pipeline - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Health Care...more

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - The House Committee on Energy and Commerce will dive further into the world of digital health this week, with a hearing focusing on how to best bridge technological advances with regulatory...more

FDA Advises it Will Not Enforce Regulatory Controls for Low-Risk Medical Information Technology Devices

The U.S. Food and Drug Administration (FDA), in conjunction with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC), recently issued a draft report...more

Dems Call for Hearing on Costs of Hep C Drug Sovaldi

Dialing up the issue of high-cost medications, Rep. Henry Waxman, the lead Democrat on the House Energy & Commerce Committee and Rep. Diana DeGette of Colorado are calling today for a hearing into the impact Sovaldi will have...more

Health Care Reform Implementation Update

The Affordable Care Act (ACA) received a great deal of attention this past week in Washington. The House held numerous hearings on implementation issues, including oversight of access to care for ACA enrollees and improper...more

Health Care Update - June 2014 #2

In This Issue: - Confusion Persists in Anticipation of 340B “Mega-Rule” - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other...more

Health Care Update - June 2014

In This Issue: - Momentum for Telemedicine Policy Reform Continues - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State...more

Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance...more

News from the Health Law Gurus™: Week of May 11th, 2014

News from the Health Law Gurus™ is a weekly summary of notable health law news from around the country with helpful links to related content. ...more

Accelerating Biomedical Innovation, Cures to Patients, and "Out of the Box" Thinking at 21st Century Cures Roundtable

A bipartisan group of Members, led by Energy & Commerce Committee Chairman Fred Upton (R-MI) and Oversight & Investigations Subcommittee Ranking Member Diana DeGette (D-CO), launched the 21st Century Cures Initiative, an...more

The Skinny on the White House Big Data Report

While the public debate on privacy has largely focused on how government, particularly the intelligence community, collects, stores, and uses data, President Obama earlier this year announced a comprehensive review of the...more

Health Care Update - May 2014

In This Issue: - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other Health Care News - Upcoming Hearings and...more

Health Care Update

In This Issue: - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other Health Care News - Upcoming Hearings and...more

Omnibus Health Care Bill (aka House Health Care Train)

The House Health & Human Services Committee passed House Bill 7113 by Representative Jason Brodeur (R-Sanford) after adopting a strike all amendment that includes provisions on health care topics previously addressed in...more

Sweeping Changes to Medicare Payment for Clinical Laboratory Services

On March 31, 2014, the Senate gave final approval to the Protecting Access to Medicare Act of 2014 (the Act), which includes significant reforms to the way Medicare pays for clinical diagnostic laboratory services. The House...more

Congress Approves Legislation Extending and Changing Medicare Programs

On March 31, 2014, the U.S. Senate approved comprehensive Medicare legislation reauthorizing and extending dozens of Medicare payment enhancements, but also making several substantive changes that will profoundly impact...more

The State of Vaccines Under the USPTO 101 Guidelines

In his State of the Union Address given on January 28, 2014, President Obama recognized the need for continued and increased investment in new technologies, including technologies specific to the biological and pharmaceutical...more

Health Care Update

In This Issue: Implementation of the Affordable Care Act; Other Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Upcoming Hearings and Markups. Excerpt from...more

The Elevator Speech Overview

The House and Senate were both on recess this week. On Tuesday, the U.S. suspended the operations of Syria’s U.S. embassy and consulates as the Syrian civil war enters its fourth year. Also Tuesday, details of an NSA...more

Democratic House Leadership Does Not Want TPP to Undermine Public Health

Last month, in a letter sent to the U.S. Trade Representative, Ambassador Michael Froman, five Representatives reiterated the importance of incorporating the 2007 Bipartisan Agreement on Trade Policy into the Trans-Pacific...more

Health Care Reform Update -- February 10, 2014

In This Issue: Implementation of the Affordable Care Act; Other Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health News; and Hearings and Mark-Ups Scheduled. Excerpt from...more

Centers for Medicare & Medicaid Services Proposes Changes to Six Protected Class Rule under Medicare Part D

On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act (the “MMA”) was signed into law by former President George W. Bush1. Prior to the enactment of the MMA, Medicare prescription drug...more

Patients Push Back on FDA Threats to 23andMe Genetic Testing Products

In a petition published on the "We the People" portion of the White House website, a group of self-titled healthcare consumers call for the Obama Administration to overrule the FDA and permit genetic testing company 23andMe...more

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