Health Science, Computers & Technology

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A&B Healthcare Week in Review, November 2015

I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

Massive Fraud Alleged by Camarillo Pharmacist

Russell Reitz, a Camarillo pharmacist, with a modest prescription-filling service, R&O Pharmacy, sold his business to Philidor Rx Services, a mail-order pharmacy, for $350,000. Reitz stayed on as manager, only to see an...more

HHS Drug Pricing Forum Highlighted in ML Strategies’ Health Care Update

This week’s ML Strategies Health Care Update highlights the recent Department of Health and Human Services (HHS) forum on prescription drug costs, which featured players from every corner of the industry, including top...more

HHS Grants 30-Day Extension on Comment Period for Common Rule Revisions

Today, the Department of Health and Human Services (“HHS”) published a Federal Register notice that extends the comment period for the Federal Policy for the Protection of Human Subjects (“Common Rule”) notice of proposed...more

Washington Healthcare Update

This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

FDA Commits to Moving Forward with LDT Regulation

Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that...more

Congress Clears Controlled Substances Act Scheduling Legislation

On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President. The legislation would amend the Controlled Substances...more

Payers Embracing Telemedicine Cost Savings, Ramping Up Reimbursement in 2016

Often considered the primary obstacle to telemedicine implementation, reimbursement changes are now better viewed as one of the most prominent drivers of telemedicine expansion. Payers are finally beginning to realize what...more

Congressional Hearing Examines Competition in the PBM Industry

Last week, pharmacy benefit manager (PBM) and independent pharmacy representatives provided testimony to the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law in a congressional hearing examining...more

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more

Health Update - November 2015

Best Practices for Using Social Media in Healthcare: Maximizing Impact, Mitigating Risk - Editor's note: In a generation more likely to seek health information online than see a doctor, social media is playing an...more

Increased risk of ‘Medjacking’ calls for better security measures on medical devices

Did you know that right now we have about 5 billion connected smart devices in use? Is it surprising that it is predicted that by 2020 that number will skyrocket to 25 billion? Of all these connected devices, a significant...more

Lab tech indicted for identity theft

A lab tech working at a Las Vegas pediatric cardiology practice has been indicted on one count of illegal use and disclosure of patient health information and one count of aggravated identity theft. The lab tech had...more

Massachusetts develops a remote controlled contraceptive chip

Ladies and gentlemen, introducing the remote controlled contraceptive computer chip. Releasing measured doses of the levonorgestrel hormone, these computer chips can be implanted under a woman’s skin as a new form of birth...more

Healthcare & Life Sciences Private Equity Deal Tracker: Warburg Pincus to Invest up to $300 Million in Vertice Pharma

Vertice Pharma, which has its U.S. headquarters in New Jersey, will focus on acquiring specialty pharmaceutical companies and products. It was launched by pharmaceutical industry veterans Don DeGolyer and Andrew Saik in...more

New HIPAA Audit Program Expected in 2016

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) recently issued a report reviewing the HIPAA audit program that is administered by the Office of Civil Rights (OCR). The OCR is responsible...more

Reflexion Health’s Digital Medicine Therapy Tool Receives FDA Clearance

San Diego-based company Reflexion Health announced that its motion-tracking based physical therapy tool Vera received FDA 510(k) clearance on October 30, 2015 (510(k) number K150462)....more

Florida Proposes Telemedicine Medicaid Rules

Florida’s Agency for Health Care Administration published proposed regulations regarding telemedicine-based services in the Medicaid program. The Agency is soliciting comments through November 23 and will host a public rule...more

Bills Introduced to Streamline FDA Review of Medical Devices

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration...more

OIG Issues HHS Fiscal Year 2016 Work Plan

The Work Plan describes more than 100 initiatives, including 43 new initiatives for the upcoming year. On November 2, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued its...more

FDA Approval of Addyi Sparks Debate

Is the controversial new drug touted as female Viagra cause for celebration or concern? Does the little pink pill represent “girl” power, or is it a shortsighted remedy for sexual dysfunction in women? Do its benefits...more

Health Care Update - November 2015 #2

FDA Hosts Genome Scientists For Next-Generation Sequencing Conference - Last week, the Food and Drug Administration (FDA) hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public...more

MedPAC Met to Discuss Part B Drug Payment Policies and Other Issues

On November 5 and 6, 2015, MedPAC held its monthly meeting in Washington, D.C. to discuss Medicare issues and policy questions, develop and approve reports, and make recommendations to Congress. Among the topics discussed...more

FDA Invites Genome Scientists to Come Play in the precisionFDA “Sandbox” - NGS Technologies Take Center Stage at Agency Campus

On November 12th and 13th, the Food and Drug Administration hosted genome scientists from across the nation at its campus in White Oak, Maryland. Two public workshops engaged presenters and audience members on various...more

Abbott Secures Preliminary Injunction in Gray Market Case

On November 6, 2015, Abbott Laboratories and its diabetes care units secured a preliminary injunction against multiple pharmacies, distributors and associated individuals engaged in the sale of gray market Abbott FreeStyle...more

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