Affordable Care Act, Centers for Medicare & Medicaid Services (CMS), Medical Devices

Health Care Week in Review: Biden Administration Announces $100 Million for ACA Marketplace Navigators and $81.3 Million for...

Alston & Bird on 9/3/2024

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Latest Open Payments Data Released Under Heightened Government Scrutiny

Foley & Lardner LLP on 7/9/2021

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

Medtronic Settles Kickback And Open Payments Violations For $9.2M

Rivkin Radler LLP on 11/13/2020

The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying...more

Capitol Hill Healthcare Update

BakerHostetler on 12/17/2019

ACA TAXES ON CHOPPING BLOCK IN YEAR-END BUDGET DEAL - Congressional leaders are poised to announce an agreement today that would permanently repeal the Affordable Care Act (ACA) taxes on medical device manufacturers,...more

Healthcare Law Update: October 2019

Holland & Knight LLP on 10/15/2019

In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

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

Hogan Lovells on 8/16/2019

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

Capitol Hill Healthcare Update

BakerHostetler on 1/8/2019

Highlights this week: how the partial government shutdown is affecting operations at the FDA; House Democrats take steps to defend the ACA; the House votes this week to renew emergency health response programs; new senators...more

Washington Healthcare Update

McGuireWoods Consulting on 12/24/2018

This Week: To shut down or not to shut down the issue as Congress tries to wrap up and leave; opioids back in the news; Alexander says he will not run for reelection in 2020. ...more

Capitol Hill Healthcare Update

BakerHostetler on 11/13/2018

Highlights this week: Democrats’ takeover of the House will yield big changes for healthcare policy in 2019; several GOP lawmakers active in healthcare policy are defeated; pharma pushes for Part D changes in the lame duck;...more

Sunshine Act Expands to Advance Practice Nurses and Physician Assistants

Mintz - Health Care Viewpoints on 10/11/2018

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

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on 3/13/2018

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

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

Skadden, Arps, Slate, Meagher & Flom LLP on 1/31/2018

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more

Capitol Hill Healthcare Update

BakerHostetler on 1/3/2018

Lawmakers return to Capitol Hill this week ahead of more self-imposed deadlines to resolve a series of thorny healthcare policies, including funding for the Department of Health and Human Services (HHS) and the rest of the...more

Capitol Hill Healthcare Update

BakerHostetler on 12/12/2017

Lawmakers last week approved a stopgap budget bill to keep the government open until Dec. 22, creating a pre-Christmas showdown over a host of spending decisions and key healthcare priorities. Republican leaders on Capitol...more

Capitol Hill Healthcare Update

BakerHostetler on 9/19/2017

Republican senators pushing a last-ditch effort to overhaul the Affordable Care Act (ACA) say they are within one vote of having the support needed to pass their bill. Sens. Bill Cassidy (R-La.) and Lindsey Graham (R-S.C.)...more

Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

Ruder Ware on 4/7/2017

The Affordable Care Act added the Physician Payment Sunshine Act (Sunshine Act) as section 1128G to the Social Security Act. The Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical...more

Capitol Hill Healthcare Update

BakerHostetler on 2/27/2017

Meeting privately with Senate Republicans to discuss next steps on the ACA was among the first actions taken last week by the new Secretary of the U.S. Department of Health and Human Services Tom Price. But GOP senators left...more

Capitol Hill Healthcare Update

BakerHostetler on 2/7/2017

House Speaker Paul Ryan last week set a deadline of the end of March for repealing most of the Affordable Care Act (ACA), as other Republican leaders and conservative rank-and-file lawmakers advocated competing policy...more

Capitol Hill Healthcare Update

BakerHostetler on 12/2/2016

After months of debate and partisan wrangling, the House on Wednesday voted 392-26 to pass the “21st Century Cures” bill designed to accelerate the development of new drugs and medical devices as well as increase federal...more

Washington Healthcare Update

McGuireWoods LLP on 7/19/2016

This Week: Double Issue — Congress leaves for seven weeks, Congress sends opioid legislation to the President…More co-ops fail…The Supreme Court rules on Texas Abortion Case and Washington state Pharmacists and Religious...more

OIG Mid-Year Updated Provides Insight To Its Concerns

Hinshaw & Culbertson LLP on 6/20/2016

The Office of Inspector General (OIG) recently released its mid-year update of its Fiscal Year Work Plan for 2016. The Work Plan summarizes new and ongoing reviews and activities that the OIG plans to pursue. Not...more

A&B Healthcare Week in Review

Alston & Bird on 4/21/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

A&B Healthcare Week in Review

Alston & Bird on 4/8/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On April 4, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the Final Calendar Year (CY) 2017 Medicare Advantage Capitation Rates and Medicare Advantage (MA) and...more

A&B Healthcare Week in Review

Alston & Bird on 3/25/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

A&B Healthcare Week in Review

Alston & Bird on 3/18/2016

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

Patient Protection and Affordable Care Act (PPACA) › Centers for Medicare & Medicaid Services (CMS) › Medical Devices

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