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OIG Claims CMS Paid $729 Million in Erroneous EHR Incentive Payments

by Baker Ober Health Law on

In a June 12, 2017 report entitled, Medicare Paid Hundreds of Millions in Electronic Health Record Incentive Payments That Did Not Comply With Federal Requirements, the Department of Health and Human Services, Office of...more

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

by Knobbe Martens on

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the...more

Rx IP Update - July 2017

by Smart & Biggar on

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Approved Biosimilar Products Around The world

Please see full chart below for approved biosimilar products around the world. ...more

2018 Proposed Rules: Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System

by King & Spalding on

On July 13, 2017, CMS issued the Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System (ASCPS) proposed rule (Proposed Rule). CMS proposes to update OPPS...more

Artificial Intelligence and Learned Intermediaries

by Reed Smith on

In the July 7, 2017, “Artificial Intelligence” issue of Science, we were intrigued by a short piece in the “Insights” section on “Artificial Intelligence in Research” that discussed the future use of autonomous robots in...more

Ninth Circuit Relies on Escobar to Revive False Claims Act Suit Against Pharmaceutical Manufacturer

On July 7, 2017, the U.S. Court of Appeals for the Ninth Circuit reversed a federal district court’s dismissal of a False Claims Act (FCA) whistleblower suit in United States ex rel. Campie v. Gilead Sciences, explaining that...more

Protecting Communications From PR Privilege Issues

by Pepper Hamilton LLP on

Two recent cases in state appellate court show the risks of sharing privileged communications with public relations consultants. But they also provide practical guidance on how to protect the confidentiality of...more

Ten Tips For Actions By A Covered Entity After A HIPAA Breach By A Business Associate

by Fox Rothschild LLP on

This blog recently discussed tips for a covered entity (CE) in dealing with a HIPAA business associate (BA). Now, even though you have adopted all of the tips and more, in this dangerous and ever more complex data security...more

Unencrypted Backup Drive of 531 EEG Patients Lost

Baptist Medical Center South, located in Jacksonville, Florida has admitted that one of its backup drives has been missing since May 18, 2017. The unencrypted backup drive contained the protected health information of 531...more

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

Vermont’s New Telemedicine Law Expands Insurance Coverage, Bans Recording

by Foley & Lardner LLP on

Vermont health care providers and patients can now enjoy a revamped, and significantly improved, telehealth commercial insurance coverage law. Vermont Governor Phil Scott signed S. 50 into law on June 7, 2017, expanding...more

Biosimilars in Europe

Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more

NY AG Fines Healthcare Firm $130,000 for Improperly Delaying Breach Notices to Consumers Due to an FBI Investigation

by Arnall Golden Gregory LLP on

On June 15th, New York Attorney General Eric Schneiderman announced a settlement with CoPilot Provider Support Services Inc. to resolve allegations that the company improperly delayed notice to more than 220,000 consumers of...more

AGG Food and Drug Newsletter - July 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

CMS Proposes Reimbursement Reduction for 340B Drugs

by Baker Ober Health Law on

When CMS issued its proposed rule for OPPS and ASC Payment System on July 13, the agency included a proposal to substantially scale back reimbursement for Part B drugs to hospitals participating in the federal 340B Drug...more

Don’t give medical device makers more time before disclosing product woes

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

CMS Considers New Billing Code Policy for Biosimilars

by Goodwin on

Last week, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule regarding payment policies. Among other things, the proposed rule included a request for comment on the policy for biosimilar...more

Journal of Nanobiotechnology Publishes Special Issue on Swiss National Research Program on the “Opportunities and Risks of...

by Bergeson & Campbell, P.C. on

The Journal of Nanobiotechnology published a special issue on the outcome of Switzerland’s five-year National Research Program on the “Opportunities and Risks of Nanomaterials” (NRP 64). The editorial states that the...more

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

Philips Acquires EGI

by Knobbe Martens on

Philips recently announced that it will purchase Electrical Geodesics, Inc. (EGI). The total value of the deal is estimated to be GBP 29.0 million (approximately $36.9 million). According to its website, EGI designs,...more

Health Alert (Australia) 17 July 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 26 June 2017 - Dr Praneal Dutt Sharma v Dr Phillip Segal and Dr Greg Chen [2017] NSWSC 867 - CONTRACT – commercial agreement...more

MRI-Compatible Robot Aims to Improve Breast Cancer Biopsies

by Knobbe Martens on

The University of Twente in Enschede, Netherlands recently introduced “the world’s smallest and most accurate 3D-printed biopsy robot,” called the Stormram 4. The device is designed to carry out biopsies during breast cancer...more

CMS Releases Proposed Rule for 2018 Physician Fee Schedule

by King & Spalding on

On July 13, 2017, CMS proposed a rule (Proposed Rule) updating payment policies and rates, as well as the quality provisions, for the Medicare Physician Fee Schedule (PFS). Among other provisions, the Proposed Rule reduces...more

Cyber Threats Equal Serious Threats

by Burr & Forman on

Every where you look these days, there seems to be another report of a cyber attack--attacks which do not discriminate based on industry type, size of business, or impact. In other words, everyone is vulnerable. In fact, the...more

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