Health Science, Computers & Technology

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Product Hopping and Antitrust: Mylan Court Dismisses Claims on Summary Judgment, Citing Need to Avoid Chilling Pharmaceutical...

A recent summary judgment opinion from the Eastern District of Pennsylvania breaks new ground in the developing antitrust law on “product hopping” claims. “Product hopping” refers to the practice of changing the form or...more

Five Employment, Labor, and Workforce Management Concerns Impacting Retailers

Retailers will be busy this summer attempting to conform their policies and procedures to various local, state, and federal laws, such as the spate of state and city sick leave laws, and analyzing proposed amendments by the...more

CMS Guidance on Beneficiary MA Drug Plan Disenrollments by Long Term Care Facilities

CMS has released guidance for long term care (LTC) facilities, including nursing facilities and skilled nursing facilities, on beneficiary disenrollments. According to the guidance, “CMS continues to see an unacceptable...more

FDA launches medical device database: AccessGUDID

On May 4, 2015, the FDA launched the most recent component of its “Unique Device Identification System,” or “UDI System,” first created in September of 2013 and required by the Food and Drug Administration Safety and...more

Nevada and North Dakota amend state breach notification laws

Nevada has amended its breach notification law, effective July 1, 2015, to include a medical or health insurance identification number and a user name, unique identifier, or e-mail address in combination with a password or...more

FDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding

On May 18, 2015, the U.S. Food and Drug Administration (“FDA”) withdrew its 2003 Compliance Policy Guide – Section 608.400, Compounding of Drugs for Use in Animals and signaled new plans to constrain animal drug compounding...more

Washington Healthcare Update

This Week: House E&C 21st Century Cures Bill Passes Unanimously Out of Committee... House Votes to Codify Permanent R&D Tax Credit... CMS Released Proposed Rule Concerning Medicaid and CHIP Plans....more

Pharmacy Board Proposed Regulations: The Next Step for Telemedicine in North Carolina

The future of telemedicine has become a hot topic in the health care industry nationwide, and the momentum seems to be in telemedicine’ s favor. Indeed, the North Carolina Medical Board recently issued revised policy...more

The Medicaid Fraud Control Units: Fiscal Year 2014 Report

The Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) has released its Fiscal Year (FY) 2014 Annual Report (Report) on the performance of the Medicaid Fraud Control Units (MFCUs)...more

The Continuing Evolution of the French Sunshine Act

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals,...more

Rare Genomics Institute Announces Crowdfunding Initiative for Rare Diseases

Earlier this month, Rare Genomics Institute, an international non-profit that makes cutting edge research technologies of genome sequencing, physicians and scientists around the world accessible to rare disease patients,...more

Manatt on Health Reform: Weekly Highlights - May 2015 #4

CMS proposes a new rule to modernize Medicaid and CHIP managed care; the Florida saga continues with CMS proposing to extend—and reduce—LIP funding; and California's Marketplace approves a co-pay cap on specialty drugs....more

CareFirst, Third Major Health Insurer This Year To Be Hit By Cyberattack

On May 20, 2015, CareFirst BlueCross BlueShield (“CareFirst”) announced that it was the latest victim of a major cyberattack, with as many as 1.1 million plan customers affected. Current and former CareFirst members and...more

Health Care Update - May 2015 #4

In This Issue: - House Energy and Commerce Unanimously Advances 21st Century Cures Legislation - Implementation of the Affordable Care Act - Federal Regulatory Initiatives - Congressional...more

Long-Term Care Legislation in Florida - Regulatory Compliance Impacts Retirement Communities, ALFs and Nursing Homes

Long-term care companies in Florida need to dust off their regulatory compliance plans to see if updates are needed in light of several bills that passed during the regular legislative session of 2015. If they are signed by...more

Fraud So Complicated It Takes a Neurosurgeon

Generally, when a doctor is convicted for fraud, the misdeeds are limited to a single category of fraud. Maybe the doctor charged for procedures that weren’t performed; maybe there were kickbacks for referrals; or maybe...more

21st Century Cures Markup Underway; Offsets Released

Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of...more

Healthcare Organizations not Immune from Criminal Attacks on Sensitive Information

This month, the Ponemon Institute released its Fifth Annual Benchmark Study on Privacy & Security of Healthcare Data and its findings are generating a good deal of attention. In the past, the Study has found that most data...more

Nevada Expands PI Definition under Data Breach Law

Becomes the fifth state to amend its data breach statute since January 2015 The definition of “personal information” (“PI”) just got a little bit bigger in the Silver State. On May 13, Nevada Governor Brian Sandoval signed...more

A Year in Review: Key HIPAA Settlement Agreements by HHS’s Office for Civil Rights

The U.S. Department of Health and Human Services Office for Civil Rights had another busy year in 2014. More resolution agreements were signed by HHS and Covered Entities than in the previous year, and several Covered...more

House Subcommittee Circulates Proposed Legislation Providing Insight on the Future of the 340B Drug Pricing Program

The 340B Federal Drug Pricing Program (the 340B Program) requires pharmaceutical manufacturers to offer drugs at discounted prices to eligible hospitals, clinics and other entities for use in the outpatient setting. The 340B...more

Watch Out! Recent Government Settlements Implicate Referring Physicians and Laboratories

$48.5 million settlement with Health Diagnostics Laboratory, Inc. and Singulex, Inc. - On April 9, 2015, the U.S. Department of Justice ("DOJ") announced a $48.5 million settlement with two cardiovascular diagnostic...more

Healthcare & Life Sciences Private Equity Deal Tracker: Shockwave Medical Secures $40 Million in Financing

Shockwave Medical, based in Fremont, Calif., develops technology for the treatment of peripheral and coronary vascular disease and aortic stenosis. It is the developer of Lithoplasty balloon catheters....more

House Energy and Commerce Committee Unanimously Approves 21st Century Cures Bill

Today the House Energy and Commerce Committee approved H.R. 6, the “21st Century Cures Act,” by a bipartisan, unanimous 51-0 vote. This major legislation is intended to accelerate the pace of medical cures in the United...more

Health Alert (Australia) - May 25, 2015

In This Issue: Judgments; Legislation; and Reports & Publications. Excerpt from Reports: Australian Medical Association (AMA) - 19 May 2015 - $19 billion pharmacy deal sign of skewed health...more

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