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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

German Federal Court: Permission granted - HIV/AIDS drug distribution continued

by Hogan Lovells on

The X. Civil Senate of the German Federal Court of Justice has granted a motion by three companies of the Merck Sharp & Dohme group (Merck) for a preliminary permission for the continued distribution of Isentress®, a drug...more

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more

Hixon: Medical records and privacy

by GableGotwals on

Many people mistakenly believe that their medical files maintained by their physicians are 100 percent private. However, there are legal scenarios in which those files are under subpoena and that require physicians to comply...more

New Jersey Court Rules That a Parent Company Is Still on the Hook for Divested Subsidiary’s ANDA Filing

by McDermott Will & Emery on

Addressing a motion to dismiss for lack of subject matter jurisdiction, a New Jersey district court held that Merck could maintain a Hatch-Waxman lawsuit against Actavis, Inc. n/k/a Allergan Finance LLC (Actavis), despite...more

A Sometimes Overlooked Fact About Express Warranty

by Reed Smith on

The warranty is “express.” Before you say, “Well, duh,” this sometimes actually does matter. Here’s how. Most complaints in product liability actions involving prescription medical products that include express warranty...more

Supply and Purchase Agreement Triggers On-Sale Bar Provision of 35 USC § 102(b)

by McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit reversed the district court and found that a Supply and Purchase Agreement between Helsinn and third-party MGI Pharma, Inc. (MGI) before the critical date of the asserted...more

Second Circuit Allows Class Action Suit Involving Diabetes Drug to Proceed

by McDermott Will & Emery on

Purchasers of Takeda Pharmaceuticals Company’s branded diabetes drug, ACTOS, filed an antitrust suit alleging that Takeda falsely described two patents to the US Food and Drug Association (FDA) and, as a result, delayed...more

Eighth Circuit Affirms Exclusion of Expert in Hip Implant Case

by Reed Smith on

We just got tickets to see “Wicked” again (we think this will be the fourth or fifth time). Since we first saw it (on Broadway in 2003, featuring Idina Menzel’s Tony-winning performance), we have loved this quirky and...more

Philips Acquires Spectranetics for $2.16 Billion

by Knobbe Martens on

According to a June 28, 2017 press release, Dutch healthcare company Philips has agreed to buy Colorado Springs-based Spectranetics Corporation, a cardiac device manufacturer, for approximately 1.9 billion euros ($2.16...more

Court Dismisses Infringement Theory Premised on Speculated Future Formulation Changes

by McDermott Will & Emery on

The US District Court for the District of New Jersey granted generic manufacturer’s motion for judgment on the pleadings under Fed. R. Civ. P. 12(c) on the basis of non-infringement. Par Pharmaceutical, Inc. v. Luitpold...more

Is Telemedicine Change Coming to Congress? The Medicare Telehealth Parity Act of 2017 Among Several New Federal Bills

by Foley & Lardner LLP on

Congress is reconsidering a nationwide telehealth coverage bill, named the Medicare Telehealth Parity Act of 2017, designed to introduce an incremental, though significant, expansion of coverage for telehealth services under...more

Court Construes “Hydrate” to Require Crystalline Form Following Battle of the Experts

by McDermott Will & Emery on

Addressing the issue of the proper construction of claims to a trihydrate compound, the US District Court for the District of New Jersey concluded that a person of ordinary skill in the art (POSA) would understand “hydrate”...more

More Telemedicine Food for Thought: Exception Five to the Haight Act’s In-Person Examination Requirement

In our July 10, 2017 post regarding telemedicine prescribing, we wrote about the seven exceptions to the Haight Act’s requirement that a provider and patient have an-person visit before a prescriber/practitioner can prescribe...more

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