News & Analysis as of

Electronic Medical Records Prescription Drugs

Wilson Sonsini Goodrich & Rosati

FDA Finalizes Guidance for Using Real-World EHRs and Medical Claims Data to Support Regulatory Decisions for Drug Products

As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more

K&L Gates LLP

CMS Finalizes New Interoperability Rule Promoting Improvements to Prior Authorization Processes

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On 17 January 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule outlining new interoperability and prior authorization requirements for certain payors (Final Rule). With the adoption of the Final...more

Kerr Russell

Accessing/Disclosing Prescription Information On Software Platforms

Kerr Russell on

Question: Our eScribe software allows us to access a patient’s prescription history. We are able to see what medications have been prescribed by other health care providers. MAPS also allows us to do this. When requesting...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - May 2023

Tens of millions of us endured the annual paper chase of tracking down and sorting through receipts and forms so we could file income tax returns. Here’s another paper exercise that promises more personal benefits than just...more

King & Spalding

FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug

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The Food and Drug Administration (FDA) has issued new draft guidance, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (the “External Controls Draft Guidance”), that...more

Holland & Knight LLP

CMS Releases CY 2022 OPPS and ASC Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) on July 19, 2021, released its calendar year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed...more

Rivkin Radler LLP

HHS, DOJ Release Fraud and Abuse Report

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The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion,...more

Bricker Graydon LLP

EHR vendor Practice Fusion agrees to $145 million settlement to resolve criminal and civil kickback violations

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On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with electronic health record (EHR) vendor Practice Fusion to resolve civil and criminal allegations that it violated the Anti-Kickback...more

ArentFox Schiff

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

ArentFox Schiff on

A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

ArentFox Schiff

Investigations Newsletter: Health Information Technology Developer to Pay $145 Million to Resolve Kickback Allegations

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In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more

Bricker Graydon LLP

What’s new with drugs?

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Pot is hot - Medical Marijuana use continues to grow in Ohio, with the Board of Pharmacy citing 73,376 registered patients and 590 physicians with Certificates to Recommend as of December 2019. Medical Marijuana sales...more

Robinson+Cole Health Law Diagnosis

DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company, that resolves parallel criminal and civil investigations...more

Epstein Becker & Green

7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 2020

Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and...more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic & the Confidentiality of Substance Use Disorder Records: an Update on 42 CFR Part 2 - Part 1...

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This episode is the first in a series focusing on recent efforts by the Substance Abuse and Mental Health Services Administration (SAMHSA) to update 42 C.F.R. Part 2 (Part 2) regulations related to the confidentiality of...more

Sheppard Mullin Richter & Hampton LLP

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more

Foley & Lardner LLP

Blockchain: A Tool With a Future in Healthcare

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Blockchain technology originated in 1991, and was conceived as a secure way to timestamp digital documents akin to how a notary timestamps physical documents. The true value lies in the fact that once stamped, the document...more

Mintz - Health Care Viewpoints

Massachusetts HPC Health Care Cost Trends Hearing: Key Takeaways

The Massachusetts Health Policy Commission (“HPC”) held its annual Health Care Cost Trends Hearing on October 16-17, 2018. The hearing covered a wide range of topics affecting the health care industry here in the Commonwealth...more

Foley & Lardner LLP

Health Care Policy Happenings - October 2018

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...Alexander: Senate Sends Opioids Legislation Called “Landmark” by Leader McConnell to President – On Wednesday, the U.S. Senate passed by a vote of 98-1, the SUPPORT for Patients and Communities Act, sponsored by Senator...more

Troutman Pepper

Real World Evidence: Implications and Challenges for Medical Product Communications in an Evolving Regulatory Landscape

Troutman Pepper on

A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients. Originally published in Update magazine - August/September 2018....more

Mintz - Health Care Viewpoints

Opioids Have Our Attention

The government is focusing on opioids. Whether it be program policies, enforcement, or legislation, combating the opioid epidemic continues to be a major focus for government officials. It is also a major piece of the...more

Baker Donelson

Real-Time EMR Interface Program to Reduce Readmissions Finds Favor in OIG Advisory Opinion 17-07

Baker Donelson on

A pilot program that could improve the efficacy of medication therapy management (MTM) services among Medicare Advantage (MA) beneficiaries would present minimal risk to federal health care programs and patients, according to...more

Baker Donelson

Real-Time EMR Interface Program to Reduce Readmissions Finds Favor in OIG Advisory Opinion 17-07

Baker Donelson on

A pilot program that could improve the efficacy of medication therapy management (MTM) services among Medicare Advantage (MA) beneficiaries would present minimal risk to federal health care programs and patients, according to...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management...

On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer...more

Butler Snow LLP

Pro Te: Solutio - Vol. 10 No. 2 – Spring 2017

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It’s Spring! In this issue of Pro Te, we do a little a “spring cleaning” to brush the dust off some familiar topics that we consider in day-to-day pharmaceutical litigation. In The Forgotten Element? Warnings Proximate...more

McCarter & English, LLP

Health Law Insights Newsletter - Issue 10 - June 2016

McCarter & English, LLP’s Health Care Group presents Issue 10 of the Health Law Insights, which discusses the latest legal issues in the health care industry. NATIONAL - Drug Diversion Case Raises Red Flags for...more

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