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

Health Care Update - November 2015 #3

Drug Pricing Issues Heat Up Following HHS Forum - Last week, the Department of Health and Human Services (HHS) hosted a forum on prescription drug costs which featured players from every corner of the industry, including...more

A&B Healthcare Week in Review, November 2015

I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

Health Care Update - November 2015 #2

FDA Hosts Genome Scientists For Next-Generation Sequencing Conference - Last week, the Food and Drug Administration (FDA) hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public...more

Washington Healthcare Update

This Week: Repealing Obamacare becomes problematic in the Senate... More focus on drug prices and reimbursement... FDA asks, should we regulate “natural” and if so, how? ...more

Health Care Update - November 2015

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Health Care Update - October 2015

Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

District Court Rules Pharmaceutical Manufacturers Are Not Required to Discount Orphan Drugs - Regardless of the Condition Being...

HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

Washington Healthcare Update

On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

A&B Healthcare Week In Review, September 2015

On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System”. This proposed rule would...more

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

ACA Menu Labeling Requirements: Draft FDA Guidance

The FDA’s 105-page final rule on chain restaurant nutrition labeling of menu items now has an associated, 53-page, draft guidance document, supplementing the FDA’s 132-page Food Labeling Guide, we learned from the September...more

Washington Healthcare Update

This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more

HRSA Issues 340B Program Omnibus Guidance

On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Employee Benefits Developments August 2015

Certain Closely Held For-Profit Employers Need Not Provide Women’s Contraceptive Services. Under the ACA, non-grandfathered group health plans must cover specified preventive services, including certain women’s preventive...more

Washington Healthcare Update

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

Health Care Update - August 2015 #2

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more

Washington Healthcare Update

This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

FDA Delays Calorie Disclosure and Menu Labeling Compliance for One Year

Restaurants now have an additional year to revise their menu boards to comply with the Food and Drug Administration’s new menu labeling rules. The FDA had previously finalized new menu labeling rules in connection with the...more

Religious Institutions: August 2015

The decision by the United States Supreme Court on same-sex marriage has been greeted with praise and disdain by different corners of the country. The faith-based community has been especially outspoken. This is not...more

Washington Healthcare Update

This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... 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

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