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OMB Releases Fall 2014 Regulatory Agenda

The White House Office of Management and Budget’s Office of Information and Regulatory Affairs has released its semi-annual Unified Regulatory Agenda and Regulatory Plan for Fall 2014, covering more than 60 Federal...more

Health Care Update - December 2014

In This Issue: - FDA Releases Menu Labeling Rule - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Upcoming Congressional Hearings - Excerpt from FDA...more

Representative Brady Introduces Discussion Draft of the Hospital Improvements for Payment Act of 2014

On November 19, 2014, House Ways & Means Health Subcommittee Chairman Kevin Brady introduced a 146-page discussion draft of the Hospital Improvements for Payment Act of 2014 (HIP). HIP seeks to, among other things, make...more

Source: [New Mexico] Human Services Secretary Squier Resigns!

“Gov. Susana Martinez’s controversial Human Services Department Secretary Sidonie Squier resigned on Thursday, sources inside the department confirmed,” according to the Santa Fe New Mexican....more

Health Care Update - October 2014

In This Issue: - CMS Publishes Long-Awaited “Health Plan Innovation Initiative” RFI - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional...more

Health Care Update - August 2014 #3

In This Issue: - Stakeholders Urge FDA to Provide Clarity on Biosimilars - Ebola Crisis Continues - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...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

Health Care Update - June 2014 #3

In This Update: - CMS Getting New Leadership Roles - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other...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

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

Law Prof: The Clean Air Act Needs a Reboot  [Video]

Feb. 24, 2014 -- Professor David Schoenbrod talks about some of the inadequacies of The Clean Air Act along with potential solutions to the problem....more

The Government Shut Down and Its Impact on Public Health

In the early morning of October 1, 2013, the U.S. federal government officially went dark. The shutdown came in the aftermath of the Senate’s decisive vote to reject a House plan that would have kept the government funded for...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

Extension of Time for Overpayment Recoveries in Fiscal Cliff Law Not as Broad as it Sounds

The recently passed fiscal cliff legislation, i.e., the American Taxpayer Relief Act of 2012 (Act) [PDF], includes a number of provisions addressing Medicare and Medicaid. One of these provisions extends the recovery period...more

Important Medicare Provisions Contained in Fiscal Cliff Compromise

On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act of 2012 (ATRA), to avert the so-called fiscal cliff. While most popular coverage has focused on ATRA’s changes to the tax code, the new law...more

Massachusetts 2013 – 2014 Legislative Session Preview

The 188th Massachusetts Legislature began the 2013 – 2014 legislative session on January 2. This alert identifies the key public policy issues that will likely emerge in the current session and offers insight into their...more

The American Taxpayer Relief Act of 2012 and Anticipated Medicare and Medicaid Payment Reforms

On January 1, 2013, the U.S. Congress approved the American Taxpayer Relief Act of 2012 (the Act), concluding a protracted debate on how to prevent the United States from falling over the proverbial “fiscal cliff.” President...more

Health Care Reform Update -- January 7, 2013

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

Congress Amends the Medicare Secondary Payer Act

On December 31, 2012, Congress sent the Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act (“the Act”) of 2012 to President Barack Obama for signature. The Act had strong bipartisan support, passing in...more

Finger-Pointing: Another Side Effect of the New Health Care Law

The Patient Protection and Affordable Care Act will change a lot of things in health care in 2013 and 2014. But the law probably won’t stop medical costs from rising — or end the search for someone to blame for the...more

Health Care Reform Update -- December 17, 2012

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

New Proposed Regulations Released Under the Affordable Care Act

The Obama administration recently released three important proposed regulations under the Patient Protection and Affordable Care Act (the "ACA"). These proposed regulations, the highlights of which are discussed below, aim...more

Massachusetts: Medical Marijuana Industry’s Steep Hill to Climb

In November 2012, Massachusetts voters passed a ballot initiative authorizing medical marijuana. This article examines some of the obstacles faced by the industry, legislators, regulators and law enforcement officials prior...more

Health Care Reform Update -- November 26, 2012

In This Issue: Leading the News: the Regs are Out!; Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings...more

Amendments to CLIA’s Proficiency Testing Provisions Passed by Congress

The Senate approved the previously House-passed Taking Essential Steps for Testing Act (also known as the “TEST Act”) this week, clearing the way for President Obama’s signature and enactment. The legislation, which amends...more

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