News & Analysis as of

Medicare Medical Devices

Impact of Value-Based Health Care on the Medical Device Industry: Three Takeaways From the Case for Transformation

by Ropes & Gray LLP on

Introduction: The Case for Transformation - In the world of fee-for-service health care, most medical devices were sold to hospitals or other health care providers for use in the diagnosis or treatment of patients. Except...more

Capitol Hill Healthcare Update

by BakerHostetler on

Congressional Republicans and President Donald Trump face a series of key questions about how or whether to fortify the Affordable Care Act – particularly in the law’s beleaguered individual exchanges – after the Senate last...more

Washington, D.C. Update – June 2017

by Baker Donelson on

Having returned from its Memorial Day recess, Congress now enters one of the longest continuous work periods of the year and – with the exception of the week of the Fourth of July – will likely be in session until the end of...more

Value-based health care: fraud & abuse laws

by Ropes & Gray LLP on

Michael Lampert, Ropes & Gray health care partner, discusses fraud and abuse law application to value-based health care arrangements. __ Much has been made about how the fraud and abuse laws, which were designed in order...more

MedPAC Takes Anti-POD Stance in Report to Congress, Echoing an Increasingly Uniform Consensus

by Ropes & Gray LLP on

On June 15, 2017, the Medicare Payment Advisory Commission (MedPAC), a non-partisan group that advises Congress on Medicare policy, released its annual Report to the Congress on Medicare and the Health Care Delivery System...more

Capitol Hill Healthcare Update

by BakerHostetler on

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

21st Century Cures: A Closer Look

by McDermott Will & Emery on

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

Healthcare Law Update: December 2016

by Holland & Knight LLP on

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

The ERISA Litigation Newsletter - December 2016

by Proskauer Rose LLP on

This month Richard Zall, Chair of Proskauer's Health Care Department, explores developments likely to occur with respect to the Affordable Care Act as a result of the new administration. In our Rulings, Filings and...more

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

by Ballard Spahr LLP on

The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

Repealing and Replacing the ACA: Five Developments Likely to Occur in the Years Ahead

by Proskauer Rose LLP on

On the back of the 2016 United States presidential election results, the health care industry ponders how a Republican president and Congress will transform the business environment. The health care industry has a number of...more

Capitol Hill Healthcare Update

by BakerHostetler on

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

CMS, FDA Parallel Review Program for Medical Devices Extended Indefinitely

by McDermott Will & Emery on

On October 24, 2016, the US Food and Drug Administration and the Centers for Medicare & Medicaid Services announced the full implementation and indefinite extension of the Program for Parallel Review of Medical Devices (the...more

FDA & CMS Extend Medical Device Parallel Review Program

by Reed Smith on

The Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have announced that they are making permanent their “Program for Parallel Review of Medical Devices,” which is now operating as a...more

FDA Uses Summer to Issue Numerous Device Guidance Documents

by Morgan Lewis on

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

CMS Proposes Update to Medicare OPPS, ASC Rates and Policies for 2017

by Reed Smith on

CMS has published its proposed rule to update the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System rates and policies for CY 2017. CMS proposes a 1.55%...more

Significant Hospital Related Mid-Year Updated OIG Review Activities

by Hinshaw & Culbertson LLP on

This is the second of three alerts discussing the mid-year update to the Fiscal Year 2016 Work Plan issued by the Office of Inspector General (OIG). In the first alert we discussed the top management performance challenges...more

Administration Releases Spring 2016 Regulatory Agenda with Timeline for Rulemaking

by Reed Smith on

The Obama Administration has posted its updated 2016 regulatory agenda, which lists major pending or planned rulemaking and the expected timing for action. The latest agenda includes numerous rules in the pipeline impacting...more

Coordinating your reimbursement and regulatory strategies for a successful product launch

by Dentons on

Ensuring appropriate third-party reimbursement for a new pharmaceutical or medical product involves an intricate interplay of considerations. There is no doubt that government and private payers have been under increasing...more

Jury Sides with Defendant in Whistleblower's Suit Alleging Defendant "Caused" False Claims

by Baker Ober Health Law on

Abbott Laboratories recently won a jury verdict in a high profile qui tam lawsuit alleging that Abbott “caused” health providers to submit false Medicare payment claims for off-label use of biliary stents. U.S. ex rel....more

A&B Healthcare Week in Review

by Alston & Bird on

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

OK to Exaggerate How Long Patients Need Device

by Faegre Baker Daniels on

Today’s riddle: Why would a federal court approve a medical device manufacturer’s practice of persuading physicians to exaggerate the period of time Medicare patients need their devices? The answer is so simple that you’ll be...more

A&B Healthcare Week in Review

by Alston & Bird on

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

by Alston & Bird on

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

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