News & Analysis as of

Patient Protection and Affordable Care Act (PPACA) Centers for Medicare & Medicaid Services (CMS) 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 -
Foley & Lardner LLP

Latest Open Payments Data Released Under Heightened Government Scrutiny

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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

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

Mintz - Health Care Viewpoints

Sunshine Act Expands to Advance Practice Nurses and Physician Assistants

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

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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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

Alston & Bird

A&B Healthcare Week in Review

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On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

McGuireWoods LLP

Washington Healthcare Update

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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

Foley & Lardner LLP

CMS Finalizes Long-Awaited Covered Outpatient Drug Rule

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The Centers for Medicare & Medicaid Services (“CMS”) recently issued a final rule implementing provisions of the Patient Protection and Affordable Care Act of 2010 (“ACA”) that pertain to Medicaid reimbursement for covered...more

Morgan Lewis

The CMS Final Covered Outpatient Drug Rule Addresses Many Industry Concerns

Morgan Lewis on

The rule implementing the Medicaid Drug Rebate Program is less burdensome and costly than what was originally proposed. In 2010, the Affordable Care Act (ACA) directed the US Centers for Medicare and Medicaid Services...more

King & Spalding

CMS Publishes Open Payments Data Detailing Payments and Transfers of Value Provided by Life Sciences Manufacturers to Physicians...

King & Spalding on

On September 30, 2014, CMS published data regarding payments and transfers of value that pharmaceutical, biologic, and medical device manufacturers provided to U.S. physicians and teaching hospitals during the period August 1...more

BakerHostetler

It Is Finally Here-the Sun Shines on a New Era

BakerHostetler on

The Centers for Medicare and Medicaid Services (CMS) publicly launched a database this week detailing the payments doctors and teaching hospitals have received from drug and medical device manufacturers. Under the Physician...more

Polsinelli

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

Polsinelli on

Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

Faegre Drinker Biddle & Reath LLP

CMS Wants To Shine Light On CME Payments To Physicians

It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more

Perkins Coie

Getting Ready For The Physician Payment ‘Sunshine’ Rule

Perkins Coie on

Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more

The Volkov Law Group

CMS Issues Rules On Physician Payments Sunshine Act

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People like to think they have it the hardest in life. I call it the competition among victims. If you are in the healthcare industry and fall under the Physician Payments regulations, then I think you are on your way to...more

Morgan Lewis

Final Sunshine Act Arrives: Now the Hard Part

Morgan Lewis on

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

Polsinelli

Physician Payment Sunshine Act Final Rule Released

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In This Issue: - Interpretation and Clarification of Key Definitions ..Applicable Manufacturers ..Applicable GPOs ..Covered Drug, Device, Biological or Medical Supply ..Covered Recipients ...more

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