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 -
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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

Closely Held Corporations Can Be Exempt from ACA Contraception Provisions Based on Religious Objections

The Patient Protection and Affordable Care Act (ACA) requires certain employers to cover women’s preventive health care under their nongrandfathered group health plans at no cost to employees. The U.S. Department of Health...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

BREAKING: Supreme Court 5-4 Finds in Favor of Hobby Lobby

Burwell v. Hobby Lobby: Regulations issued by the U.S. Department of Health and Human Services under the Affordable Care Act required that employers provide coverage for 20 contraceptive methods approved by the Food and Drug...more

Health Update - June 2014

In This Issue: - Judge Rules Against 340B Drug Authority - FDA Approves Skin Infection Drug - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...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

Notice to Plans and PBMs: Pay for Contraceptive Services and Maybe We Will Pay You Back

As has been widely covered in the news, regulations and guidance developed under the Affordable Care Act (“ACA”) require that non-grandfathered health plans make preventive care and screenings available to their members at no...more

ERISA Fiduciary Duties and the Tension Between the Affordable Care Act and the Religious Freedom Restoration Act

The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food...more

Health Care Reform Update -- January 21, 2014

In this issue: Implementation of the Affordable Care Act; Other Federal Regulatory Initiatives; Other Congressional and State Initiatives; and Hearings and Mark-Ups Scheduled. Excerpt from Implementation of the...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

Does Obamacare Strike the Right Balance Between Women’s Contraceptive Rights and Religious Freedom?

Effective for plan years beginning on or after January 1, 2014, employer-sponsored group health plans that are not grandfathered must provide women with access to a list of 16 contraceptive services without cost sharing...more

FDA Deputy Commissioner Details Agency’s Priorities In Recent Speech

In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...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

Tax Talk -- Volume 6, No. 3 -- October 2013

In This Issue: A Primer on the Medical Device Excise Tax; FATCA Registration Begins; In re Downey Financial Corp. (U.S. Bankr. Court Dist. of Delaware 10/8/2013); In re NetBank (11th Cir. 9/10/2013); and In re...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

U.S. Federal Government Shutdown: Daily Update #5

U.S. House of Representatives - On Monday, the House passed another targeted continuing resolution (CR) that would authorize funds for the Food and Drug Administration (FDA). This bill joins the other targeted CRs...more

U.S. Federal Government Shutdown: Daily Update #4 -- Weekend Highlights

House of Representatives - On Friday, House Democrats announced they plan to file what is known as a discharge petition on a bill that has been with the Appropriations Committee since March. The discharge petition is...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

Health Care Reform Update -- July 29, 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

Biosimilars Webinar - July 23, 2013

On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop...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

Tenth Circuit Rules in Favor of Religious For-Profit Corporations in Birth Control Litigation under the Affordable Care Act

In Hobby Lobby Stores, Inc. et al. v. Sebelius, et al.,1 an en banc panel of the U.S. Court of Appeals for the Tenth Circuit held that Hobby Lobby Stores Inc. and Mardel Inc., two for-profit corporations owned and operated by...more

Health Care Reform Update -- July 1, 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

"Health Care Enforcement Update: What Is in Store for the Next Five Years"

While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more

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