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Centers for Medicare & Medicaid Services (CMS) Medical Research

Health Care Compliance Association (HCCA)

[Virtual Event] Research Compliance Conference - November 12th, 8:00 am - 5:00 pm CT

Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more

Holland & Knight LLP

Holland & Knight Health Dose: February 27, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Holland & Knight LLP

Holland & Knight Health Dose: January 24, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

BakerHostetler

Healthcare Industry Team 2023 Year in Review

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As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more

Manatt, Phelps & Phillips, LLP

What the Hospital-at-Home Movement Tells Us About Igniting Innovation in Health Care

Editor’s Note: In a recent op ed first published in STAT’s First Opinion, James Rebitzer and Robert Rebitzer—coauthors of the new book Why Not Better and Cheaper? Healthcare and Innovation—discuss the innovative...more

Ankura

Understanding the New Medicaid Research Coverage Regulation

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On January 1, 2022, the new Medicaid clinical research coverage law became effective requiring states to add clinical research coverage as a mandatory benefit for Medicaid enrollees. In response, research teams, revenue cycle...more

Benesch

Dialysis & Nephrology Digest - April 2023

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ME trial reminiscent of DaVita anti-poaching case that also ended in acquittal; DOJ strategy questioned - In Apr. 2022, juries in TX and CO acquitted healthcare companies charged by the DOJ’s Antitrust Division. In the CO...more

Health Care Compliance Association (HCCA)

[Virtual Event] Healthcare Enforcement Compliance Conference - November 7th - 9th, 8:55 am - 3:30 pm CST

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us virtually at HCCA’s Annual Healthcare Enforcement Compliance...more

Benesch

Dialysis & Nephrology Digest - March 2022

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CMS calls for applications for second cohort of KCC Model; deadline set for Mar. 25 - The Center for Medicare and Medicaid Innovation says performance period participation agreements for the CMS Kidney Care First Option...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Benesch

Dialysis & Nephrology Digest - January 2022

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Benesch reviews state, federal modifications to restrictive covenant laws - In a “Year-End Review,” Benesch points out there was considerable activity in trade secret and restrictive covenant law in 2021. Some of the...more

Benesch

Dialysis & Nephrology Digest - July 2021

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OSHA introduces mandatory workplace rule to protect healthcare workers from COVID The Occupational Safety and Health Administration (OHSA) issued an emergency temporary standard (ETS) that sets out how it wants workplaces...more

Faegre Drinker Biddle & Reath LLP

Long-Awaited 21st Century Cures Act 2.0 Draft Released

Following months of anticipation by stakeholders including patient organizations, research institutions and medical product developers, Representatives Fred Upton (R-MI) and Diana DeGette (D-DO) released a 21st Century Cures...more

Benesch

Dialysis & Nephrology Digest - March 2021 #3

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Study contends lifestyle, chronic ailments to drive 56% growth in value of global peritoneal dialysis market through 2027 - A report (available for purchase) from Canadian research firm Emergen Research suggests the...more

Holland & Knight LLP

Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves...

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FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more

Baker Donelson

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

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The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

Polsinelli

2017 Omnibus Agreement: Key Health Provisions

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Congress has completed action on H.R. 244, the “Consolidated Appropriations Act for FY 2017” [P. L. 115-31]. This bipartisan legislation, which funds the Federal government for the balance of the fiscal year, passed the House...more

Foley & Lardner LLP

21st Century Cures Act Provides Some Welcome Relief

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The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the...more

Knobbe Martens

Reducing the Delay Between FDA Approval and CMS Reimbursement Coverage

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The Centers for Medicare & Medicaid Services (CMS) recently confirmed that the Parallel Review program (first announced in 2010 and most recently extended until December 18, 2015) will be made permanent. ...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Obamacare repeal passes Senate and goes to the House... Tax extenders still under development... Focus on drug pricing continues... Congress looks to create an omnibus appropriations bill to fund the government by...more

King & Spalding

CMS Open Payment Program Data Indicates $6.49 Billion Paid by Manufacturers, GPOs to Physicians and Hospitals in 2014

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CMS recently released data collected through the Open Payments Program in accordance with the Affordable Care Act from applicable manufacturers and group purchasing organizations (GPOs) about payments and other transfers that...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: House Approves FY 2016 Budget Proposal... House Passes Permanent SGR Reform and Two-Year CHIP Reauthorization... Senate Passes FY 2016 Budget Plan... HHS Report: ACA Led to $7.4 Billion Decline in Uncompensated...more

Cooley LLP

Is CMS Feeling the Sunshine Heat? – Part 2

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As follow-up to our recent post on the issues that the Centers for Medicare & Medicaid Services (CMS) is experiencing with its Open Payments database, there is new information that additional data also may be excluded when...more

BakerHostetler

Academic Medical Centers: Clinical Care, Research and Teaching (or Maybe Not?)—Graduate Medical Education and the Future

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In the world of healthcare policy and law, we usually discuss issues impacting providers, but don’t often report about the training and infrastructure behind what allows our healthcare system to treat patients in our...more

Foley & Lardner LLP

OIG Releases Report on Questionable Billing for Sleep Studies; CMS to Take Action

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The Office of the Inspector General (OIG) released a report earlier this month on Medicare spending on polysomnography (sleep studies to diagnose and guide treatment for conditions such as sleep apnea), which indicated that...more

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