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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

Health Care Reform Update -- November 25, 2013

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

Congress Wades in to Medical App Oversight

In September 2013, the Food and Drug Administration (FDA) issued final guidance regarding its regulation of mobile device medical apps. As expected, it reserved its scrutiny for apps that are truly “medical devices” (because...more

Health Care Reform Update -- November 12, 2013

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

The FDA’s Latest One-Two Punch to Combat Drug Shortages

On October 31, 2013, the U.S. Food and Drug Administration (“FDA”) unveiled its latest steps for preventing and resolving prescription drug shortages. First, the agency announced a proposed rule requiring manufacturers of...more

Health Reform + Related Health Policy News - October 2013 - Issue 3

In This Issue: - Top News ..Deal to Raise Debt Ceiling, End Shutdown Yields No Major Changes to Health Care Law ..Problems with HealthCare.gov Website Continue; HHS Working to Fix Issues ..Kaiser Study...more

Governor Brown Vetoes California Biosimilar Bill

Last week, Governor Jerry Brown vetoed a California bill (SB-598) that would have authorized a pharmacist to select a biosimilar when filling a prescription order for a prescribed biological product, provided that the...more

California Biosimilar Bill Aligns with BIO Principles on Biologic Substitution

Yesterday, we noted that the Generic Pharmaceutical Association (GPhA) recently expressed its opposition to a California bill (SB-598) that would authorize a pharmacist to select a biosimilar when filling a prescription order...more

Grassley Turns His 340B Microscope on Manufacturers

For the first time, Senator Grassley has turned his scrutiny of the 340B Drug Pricing Program to pharmaceutical manufacturers. As we previously wrote, Senator Grassley has been among the most vocal of critics in...more

GPhA Opposes California Biosimilar Bill; Points to Report on Savings from Biosimilars

Last week, the Generic Pharmaceutical Association (GPhA) released a statement regarding a California bill (SB-598) that the GPhA asserted would "introduce[] burdensome provisions that could raise costs and limit patient...more

Bipartisan Agreement Reached on Legislation Granting FDA Greater Authority to Regulate Drug Compounders

Last week, Democrat and Republican leaders of both houses of Congress agreed to the terms of a bill that would give the U.S. Food and Drug Administration (FDA) greater authority to regulate drug compounding and would revamp...more

Obamacare Small Business Exchange Delayed

Mounting technical delays are complicating the implementation of the Affordable Care Act, aka Obamacare. The website Politico is reporting that the Obama Administration intends to delay a portion of Obamacare aimed at...more

BIO Reiterates Support for 12-Year Data Exclusivity Period for Biologics

Last month, in a letter to the U.S. Trade Representative, Ambassador Michael Froman, Biotechnology Industry Organization (BIO) President and CEO James Greenwood expressed support for the efforts of the Obama Administration to...more

House Subcommittee Hears Testimony on Developing Mobile Medical Applications

Nearly one in three cell phone owners have used their phone to look for health information. Approximately 19% of smartphone owners have downloaded a mobile medical application (Medical App). These and many more statistics...more

Health Care Reform Update -- June 10th, 2013

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

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