The United States Food and Drug Administration Patient Protection and Affordable Care Act (PPACA)

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

Washington Healthcare Update

This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more

Also In The News - Health Headlines - July 2015

CMS Reopens Attestation Period For First-Time Hospitals Until August – CMS recently announced that eligible hospitals participating in the Medicare Electronic Health Record Incentive Program for the first time in 2015 may...more

Health Update - July 2015

Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more

Washington Healthcare Update

This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more

Employee Benefits Developments - June 2015

Supreme Court: Plan Fiduciaries Have a Continuing Duty to Monitor Plan Investments. In 2007, participants and beneficiaries under a 401(k) plan sued the plan fiduciaries and the plan sponsor to recover damages for alleged...more

FDA Extends Menu Labeling Compliance Date

On July 9, 2015, the U.S. Food and Drug Administration (FDA) announced that it is extending the date for compliance with its menu labeling requirements by one year. Under the new timeframe, businesses covered by the menu...more

Health Care Update - July 2015

In This Issue: - Medicare Releases Set of Payment Rules, Physician Fee Schedule on Deck - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional Initiatives - Other...more

Departments Issue Additional Guidance on Preventive Services

The Departments of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively, the Departments) issued guidance in the form of FAQs on the ACA’s preventive services mandate. The ACA requires non-grandfathered...more

Washington Healthcare Update

This Week: GOP Post-King Contingency Bills Released in Both the House and the Senate... House E&C Committee Draft LDT Bill – Creates FDA In Vitro Center, Sets Agency Review Timeline and Defines Risk Categories... CMS...more

Washington Healthcare Update

This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more

Washington Healthcare Update

This Week: House E&C 21st Century Cures Bill Passes Unanimously Out of Committee... House Votes to Codify Permanent R&D Tax Credit... CMS Released Proposed Rule Concerning Medicaid and CHIP Plans....more

Health Care Update - May 2015 #4

In This Issue: - House Energy and Commerce Unanimously Advances 21st Century Cures Legislation - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional...more

Spring Regulatory Agenda Sets Forth New Deadlines, Proposals

In keeping with past practice, federal agencies released their spring regulatory agendas on the eve of a holiday weekend. These semiannual reports list all of the federal agency regulations currently under development or...more

Washington Healthcare Update

This Week: Health Subcommittee Advances 21st Century Cures, Full Committee Action Scheduled…Senate Finance Committee Hearing: Chair Hatch to Launch New Initiative on Improving Chronic Care for Medicare Patients…Hawaii’s...more

New FAQs Regarding Preventive Services Under Healthcare Reform McGuireWoods Healthcare Reform Guide: Installment No. 49

This is the 49th in a series of WorkCite articles concerning the Patient Protection and Affordable Care Act and its companion statute, the Health Care and Education Reconciliation Act of 2010 (referred to collectively as the...more

Washington Healthcare Update

This Week: House E&C Releases Discussion Draft of 21st Century Cures Legislation Ahead of Legislative Hearing... FDA Finalizes Biosimilar Guidance Documents... CMS Updates Wage Index and Payment Rates for the Medicare Hospice...more

Health Care Update - April 2015 #3

In This Issue: - House E&C Proceeds with Cures Initiative this Week - Congress Continues Budget Considerations; Health Care Playing Leading Role - Implementation of the Affordable Care Act - Other Federal...more

Washington Healthcare Update

This Week: Energy and Commerce Health Subcommittee Explores Post-Acute Bundling…CMS Releases First-ever Hospital Compare Star Ratings…Fiscal Year 2016 Proposed Inpatient and Long-term Care Hospital Policy and Payment Changes....more

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more

Healthcare Legal News Volume 5 Number 2

According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...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

Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute [Video]

The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...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

What’s on the Menu? A Look at the New FDA Quick Serve Restaurant (QSR) Labeling Requirements

We recently reported in to our clients about a little-known element of the Affordable Care Act (“Obamacare”) that will require many QSRs (Quick Serve Restaurants) to provide specific calorie and nutrition information to their...more

Washington Healthcare Update

This Week: President’s FY2016 Budget Request... FDA Commissioner Hamburg to step down... Tennessee Medicaid expansion plan rejected by legislature. 1. Congress House House Ways and Means Committee Hosts Hearing...more

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