Elections & Politics Administrative Agency Health

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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

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

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

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

Washington Healthcare Update

This Week: Energy and Commerce Hearing Examines ICD-10 Preparedness... HHS Announces Oncology Care Model Initiative... Pennsylvania Governor Abandons Alternative Medicaid Expansion Approach for Traditional Plan....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

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

"2014-15 Supreme Court Highlights"

Approaching the midpoint of its 2014-15 term, the Supreme Court has added to its docket several cases with potentially wide-reaching implications for a range of important policy and business issues. The Court accepted for...more

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

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