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Patient Protection and Affordable Care Act (PPACA) › Manufacturers

The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +
The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal subsidies to reduce the number of uninsured citizens. less -
ArentFox Schiff

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

ArentFox Schiff on

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

McDermott Will & Emery on

On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q3 2022

Bass, Berry & Sims PLC on

The third quarter of 2022 brought a number of noteworthy False Claims Act (FCA) settlements, including several over $20 million and one in the high nine figures. This post summarizes key settlements of interest to healthcare...more

Foley & Lardner LLP

A Recap of President Joe Biden’s State of the Union Address

Foley & Lardner LLP on

Tuesday night, President Joe Biden spoke to Congress in his first State of the Union address. In an hour long speech, President Biden covered a variety of topics and urged Congress to pass numerous pieces of legislation....more

Jackson Lewis P.C.

2022: The Year Ahead for Employers

Jackson Lewis P.C. on

In 2021, the workforce continued adapting to an evolving global pandemic, increasingly consequential social movements and a dramatic shift in employment policy ushered in by a change of leadership at the federal level. ...more

Foley & Lardner LLP

Latest Open Payments Data Released Under Heightened Government Scrutiny

Foley & Lardner LLP on

On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

K&L Gates LLP

340B Update: Federal Court Halts 340B Administrative Dispute Resolution Rule

K&L Gates LLP on

Safety net providers participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers imposing restrictions on 340B contract pharmacy arrangements. In response to these actions, the...more

King & Spalding

Federal Judge Blocks Implementation of 340B ADR Final Rule

King & Spalding on

On March 16, 2021, a federal judge issued a preliminary injunction blocking HHS from implementing the 340B administrative dispute resolution final rule (the Final Rule) released in December 2020. The blocked Final Rule would...more

K&L Gates LLP

Trump v. Biden: What Might the Next Four Years Look Like?

K&L Gates LLP on

Quickly approaching November 3, 2020, we are in the final days of what is expected to be a contentious and consequential presidential election in the United States. With the whirlwind news cycles at the end of the campaign...more

Seyfarth Shaw LLP

Sad Day for Coupon-Clippers

Seyfarth Shaw LLP on

Seyfarth Synopsis: Recently, the Trump Administration issued its proposed Notice of Benefit & Payment Parameter for 2021 regulations....more

Kilpatrick

Departments Delay Implementation of Controversial HHS Prescription Drug Rule

Kilpatrick on

In ACA FAQ Part 40, HHS, IRS and DOL (the "Departments") delayed the implementation of the controversial rule in HHS 2020 Notice of Benefit and Payment Parameters requiring health plans to credit to the out-of-pocket maximum...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Hogan Lovells on

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

K&L Gates LLP

HHS Finalizes Regulation on Cost-Sharing Limitations and Drug Manufacturer Coupons

K&L Gates LLP on

The Department of Health and Human Services (“HHS”) recently finalized a regulation (the “Regulation”) that informs employers how group health plans may account for drug manufacturer coupons for purposes of the Affordable...more

Kilpatrick

Are Manufacturer Drug Coupons and HDHPs a Good Fit

Kilpatrick on

In our last blog past, we discussed the recent rule finalized by Health and Human Services regarding the calculation of the annual cost-sharing limits for health plan participants who receive financial assistance from drug...more

Mintz - Health Care Viewpoints

Sunshine Act Expands to Advance Practice Nurses and Physician Assistants

Mintz - Health Care Viewpoints on

Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

Butler Snow LLP on

It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Polsinelli

Laws and Regulations Affecting Government Contractors

Polsinelli on

How Trump’s “Buy American and Hire American” Could Alter Procurements - The President’s “Buy American and Hire American” Executive Order (EO), issued April 18, 2017, reflects Executive Branch policy and orders several...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

Polsinelli

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

Polsinelli on

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

K&L Gates LLP

340B Update: HRSA Finalizes 340B Pricing & Penalties for Drug Manufacturers

K&L Gates LLP on

On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more

Robinson+Cole Manufacturing Law Blog

Election 2016:  WOW, Just WOW

Robinson+Cole Manufacturing Law Blog on

I had a blog piece almost done. It was going to give an overview of another NLRB case which threatened to overturn settled law and expand the rights of unions to organize. I was going to use it as another “Year of Change”...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

1. Congress - Senate - FDA Supports Expanded Authority Over Cosmetics - In an Oct. 5 letter to Senator Dianne Feinstein (D-CA), the Food and Drug Administration (FDA) says its current legal authority over...more

Pierce Atwood LLP

Under the Dome: Inside the Maine State House

Pierce Atwood LLP on

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. Community Health Options to Focus on Maine by Leaving New Hampshire In 2017, New Hampshire...more

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