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... 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.
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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
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
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
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
INTRODUCTION - On April 10th, President Obama submitted his FY 2014 Budget Proposal to Congress. In the normal course of events, the President would have unveiled his spending plan in early February as required by law....more
While Congress was in recess, the Centers for Medicare and Medicaid Services (CMS) surprised many when it changed course on Medicare Advantage payment rates – switching from a 2.3 percent reduction to a 3.3 percent increase,...more
Last week, the Department of Health and Human Services (HHS) conditionally approved state partnership marketplaces in Iowa, Michigan, New Hampshire and West Virginia; Accountable Care Organizations wrote to the Centers for...more
In This Issue: - Forecast for the Physician Payments Sunshine Act: Partly Cloudy - Document Preservation Notices and the Lists of Who Receive Them: Are They Discoverable? - FDA Warning Letters Through...more
The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more
Last week another marketplace deadline came and went, Illinois became the 21st state approved to operate a health insurance marketplace, and U.S. senators pressed the HHS official responsible for the bulk of exchange...more
On February 8, 2013, 16 months after the statutory deadline, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the final regulation implementing the physician payment transparency...more
In This Issue: - Top News ..CMS Announces Round 2 Competitive Bidding Single Payment Amounts ..CBO Lowers SGR Repeal Cost by $100 Billion ..Republicans Press HRSA on 340B Audits ..HHS Proposes...more
On December 5, 2012, the Internal Revenue Service (IRS) published final regulations regarding the implementation of the excise tax applicable to the sale of certain medical devices, enacted by the Patient Protection and...more
In This Issue: - CMS Releases FY 2012 Financial Report; Misses Target forReductions in Improper Payments - CMS Releases Guidance on Medicaid/CHIP Issues - HHS Secretary Extends Deadline for Decision on...more
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