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Front End Changes and, Again, More DIR Columns

Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS...more

Medical Information More Valuable to Hackers Than Credit Card Numbers

In light of the recently reported large healthcare data breaches that have resulted in the potential theft of the personal information of millions of patients, the FBI warned healthcare providers yet again of the dangers of...more

The New EU Clinical Trials Regulation Aims at Harmonization and Transparency

On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more

Health Care Reform Implementation Update

In the past week, CMS has released several advisories including updates to the rating system for nursing homes, premium and deductible information for Medicare Part B and Part D for 2015, Pioneer ACO results, payment dispute...more

Will your errors and omissions policy pay your defense costs?

The hypothetical - HealthPayPlus (HPP) designs custom record management systems for large hospital systems. HPP developed a system for Research Hospitals of America (RHA) that HPP promised would revolutionize RHA’s...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

Introducing a New Drug Into the Marketplace in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Mindful that this series of articles describes biotech ventures that are ripe for initial public offerings even before launching an income-producing drug product into the commercial market, the paramount objective for all...more

Health Alert (Australia) - October 20, 2014

In This Issue: Judgements, Legislation, and Reports. Excerpt from Judgments: Commonwealth - 15 October 2014 - Gray v Richards [2014] HCA 40 - In 2003, a 10-year-old girl...more

OIG Proposed Anti-Kickback Safe Harbors and CMP Regulations: The End of Frustration or Just the Beginning?

On October 3, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published an unexpected, yet long-awaited, set of proposed rules that would add new anti-kickback law safe harbors,...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

Highlights of OIG's Proposal to Amend Safe Harbors to the Antikickback Statute and CMP Rules, and to Add New Safe Harbors

On October 3, 2014, the Department of Health and Human Services Office of Inspector General (OIG) issued a proposed rule to establish new safe harbors under the antikickback statute and the civil monetary penalty (CMP) rules,...more

Health Headlines: Also in the News - October 2014

On September 30th, the Food and Drug Administration (FDA) released draft guidance concerning the proposed oversight framework for regulating laboratory developed tests....more

Device Advice: New Guidance From the FDA on Medical Devices and Cybersecurity

Are medical devices, subject to pre- and post-market regulatory controls, under increasing cybersecurity scrutiny? The FDA recently published recommendations for consideration of cybersecurity management in a product’s design...more

OIG Proposes Favorable Changes To The Anti-Kickback And CMP Regulations

On October 3, 2014, the Office of Inspector General (OIG) published a favorable proposed rule that would make changes to the anti-kickback and civil monetary penalties (CMP) regulations. This proposed rule clarifies...more

Health & Human Services, Office of Inspector General, Proposes New Fraud and Abuse Rules

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) published 79 Fed. Reg. 59717 on October 3, 2014. This proposed rule has the potential to have an impact on a broad array of financial...more

New Challenge to 340B Rule Regarding Orphan Drugs

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more

HITECH Act Assures Meaningful Use & Care Coordination…For Some

The passage of the ARRA HITECH Act in 2009 fostered significant advancements in patient engagement and care coordination by incentivizing primarily physical health providers and acute care hospitals to make smarter use of...more

Does the Medicare Telehealth Parity Act of 2014 Stand a Chance?

“Telehealth saves money and helps save lives. By expanding telehealth services, we can make sure the best care and the best treatments are available to all Americans, no matter where they live.” With those words, Rep....more

China Widens Entry to Medical Device Market to Investment, Innovation While Tightening Regulations on Existing Market Products

As the medical device industry in China continues accelerated growth, investors seek to capitalize on a roughly $65 billion market that is growing at an annual rate of 21 percent. Under recent changes to the regulatory...more

Phrma Challenges HRSA Interpretative Rule On Orphan Drugs In The 340B Drug Discount Program

On October 9, 2014, the Pharmaceutical Research & Manufacturers of America (“PhRMA”) filed a lawsuit seeking to enjoin the Health Resources Services Administration (“HRSA”) from implementing its July 23, 2014 “Interpretive...more

Guest Post: Myriad -- A Direct and Unexceptional Approach

Is there a chain of reasoning that leads to the outcome in Myriad more shortly and directly than that outlined by Justice Thomas and without invoking judicial exceptions? It is strongly arguable that this is indeed the case...more

Good News: California Extends Its Medical Data Breach Notification Requirement From 5 to 15 Days

On Sept. 18, 2014, California’s governor approved Assembly Bill 1755, extending California’s stringent breach notification deadline for medical information breaches from five business days to 15 business days for clinics,...more

CMS Publishes Open Payments Data Detailing Payments and Transfers of Value Provided by Life Sciences Manufacturers to Physicians...

On September 30, 2014, CMS published data regarding payments and transfers of value that pharmaceutical, biologic, and medical device manufacturers provided to U.S. physicians and teaching hospitals during the period August 1...more

Africa Update - October 2014 #2

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from Leading the...more

Ninth Circuit: City's Pioneering Drug-Disposal Ordinance Does Not Violate Commerce Clause

If your medicine cabinet is filled with old prescriptions and other medications that you no longer want or can use, you might have asked: how and where should I get rid of these? Local governments are beginning to...more

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