The United States Food and Drug Administration Centers for Medicare & Medicaid Services

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

FDA Approves Cancer Screening Test as First Device Under Parallel Review Pilot

On August 11, 2014, the Food and Drug Administration (FDA) issued a premarket approval (PMA) for Exact Sciences’ Cologuard, a colorectal cancer screening test, and the Centers for Medicare & Medicaid Services (CMS) issued a...more

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

FDA Set to Regulate LDTs - Citing Safety Concerns and Advanced Technologies

Advances in medical technology have increased the use of diagnostic tests to guide therapeutic decisions for many diseases and conditions, especially in the context of personalized medicine. Citing the need to ensure that...more

Health Care Update - July 2014 #3

In This Issue: - First Guidance following Hobby Lobby released - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State...more

Personalized Medicine Today: PMC Issues Fourth State of the Industry Report

Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the...more

Health Care Update - June 2014 #4

In This Issue: - Hobby Lobby decision further complicates ACA implementation - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State...more

Regulating Point of Care Diagnostics

Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or...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 Markups -...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

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - This Week’s Hearings: - Wednesday, January 15: The House Committee on Veterans’ Affairs will hold a hearing titled “Vendors in the OR- VA’s Failed Oversight of Surgical Implants.” The House...more

Health Reform + Related Health Policy News - December 2013

In This Issue: - Top News ..CMS Releases Payment Rules for the Medicare Physician Fee Schedule, Hospital Outpatient Prospective Payment System, Renal Dialysis and Home Health ..President Signs the Drug Quality...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

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - The House will take another turn this week on hearings related to health care reform implementation with a focus on the Healthcare.gov website troubles. The House is also planning a vote on H.R....more

Health Reform + Related Health Policy News - October 2013

In This Issue: - Top News ..Judge Orders $237.4 Million Penalty Against Tuomey for Stark Law and False Claims Act Violations ..Glitches and Demand Lead to Marketplace Frustration ..HHS Delays Small...more

Impact of Government Shutdown on HHS

Health care providers and health care companies are required to work with federal regulatory agencies on a daily basis. As a result, many are wondering exactly how the government shutdown will impact their businesses. The...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

Health Care Reform Update -- September 30, 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

Capital Thinking: Health Care

LEGISLATIVE ACTIVITY - CR Wrangling - The House approved H. J. Res. 59 last week, a Continuing Resolution (CR) to fund the government through December 15 at sequester funding levels. As expected, the resolution...more

CMS Proposes New Standards and Processes for Medicare Coverage of Investigational Devices and Related Clinical Studies and Trials

In its proposed update to the Physician Fee Schedule for calendar year 2014, the Centers for Medicare & Medicaid Services (CMS) suggested major revisions to its regulations governing Medicare coverage of investigational...more

Health Reform + Related Health Policy News - July 2013

In This Issue: - Top News ..Obama Administration Delays Employer Mandate One Year ..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix ..CMS Proposes Payment Changes for Medicare...more

Health Care Reform Update -- June 17th, 2013

In This Issue: Leading the News; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearing and Mark-Ups Scheduled. Excerpt from Leading the News...more

Health Reform + Related Health Policy News - June 2013

In This Issue: - Top News ..CMS Finalizes MLR Rule for Plans, Maintaining Application to Part D Sponsors ..Early State Filings Show Premium Reductions under ACA ..HHS Received More Than 830 Letters of...more

Health Care Reform Update -- June 3rd, 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

Health Care Reform Update -- May 13, 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

Health Care Reform Update -- May 6, 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 Scheduled....more

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