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FDA Draft Guidance Clarifies Criteria and Process for Obtaining Rare Pediatric Disease Priority Review Vouchers

On November 17, 2014, the Food and Drug Administration (“FDA”) released a draft guidance entitled Rare Pediatric Disease Priority Review Vouchers, which describes an incentive program for the development of drugs intended to...more

China Issues Draft Guidance on Multi-Regional Clinical Trials

On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21. The Guidance aims to set forth...more

Encryption and Securing BYO Devices at the Heart of Massachusetts AG $100,000 Settlement

The Massachusetts Attorney General announced Friday that her office had reached a settlement with Beth Israel Deaconess Medical Center (BIDMC) surrounding a 2012 data breach in which a physician’s unencrypted personal laptop...more

FDA Issues Three Guidance Documents for Outsourcing Facilities

FDA has announced the availability of two Final Guidance documents and one revised Draft Guidance related to Section 503B outsourcing facilities. FDA published the three guidance documents Friday afternoon. The Final...more

Essential Medical, Inc. Successfully Completes First in Man Studies for MANTA Large Bore Vascular Closure Device

Essential Medical, Inc., a privately held medical device company aiming to create and commercialize new vascular closure devices for femoral punctures after cardiac catheterization procedures, announced that it has...more

Seventh Circuit Holds Pharmacy Billing Medicaid For Drug Prices Above Private Rates Is Not Fraudulent

On November 12, 2014, the Seventh Circuit upheld the dismissal of a False Claims Act action challenging a retail pharmacy chain’s practice of billing Medicaid for the price differential between the higher Medicaid-negotiated...more

Connecticut Supreme Court Issues Decision That Could Expand State Law Liability in Data Breach Class Actions for Businesses...

Health care providers have not escaped the recent proliferation of data breach class actions, but plaintiffs generally have been unsuccessful in bringing claims based on the Health Insurance Portability and Accountability Act...more

Meaningful Use Attestations - Be Careful of What You Attest To

Under the American Recovery and Reinvestment Act of 2009, eligible health providers who demonstrate “meaningful use” of certified electronic health record (EHR) technology can qualify for incentive payments under the Medicare...more

Health Law Pulse - November 2014

In This Issue: - Connecticut Supreme Court: HIPAA Does Not Preempt Negligence Claims - CMS Removes Continuing Education Exemption to Physician Payments Sunshine Act - Federal Government and New York...more

CMS Changes Sunshine Rules for CME, Revises List of Data Elements to be Reported

The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more

Telemedicine Technology: Tackling Rural Health Care Challenges

In honor of National Rural Health Day on November 20, it’s important to recognize the challenges — and opportunities — facing health care providers in delivering the highest quality care to rural populations. Our recent...more

HRSA Withdraws Proposed “Mega Rule” for 340B Drug Pricing Program

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing...more

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more

CMS Updates Manual Instructions to Implement CY 2014 MPFS Changes for Reimbursement of Investigational Devices and Related...

On November 6, 2014, CMS announced changes to its Medicare Benefit Policy Manual and Medicare Claims Processing Manual related to coverage of items and services in Category A and B Investigational Device Exemption (IDE)...more

Just In Time for the Holidays: More Security Requirements From NIST

National Institute of Standards and Technology (NIST) has published draft recommendations aimed at securing the confidentiality of sensitive federal information located within non-federal entities’ information technology...more

Insurance Antitrust Legal News - November 2014 - Volume 3 - Number 6

Plaintiff Files Third Amended Antitrust Claim Against Highmark - A long running antitrust dispute in Western Pennsylvania continued on October 1, when a Pennsylvania hotel (Cole’s Wexford Hotel) filed a third amended...more

Comments Sought by December 19th on the FDA's Proposed Criteria for "First Generic" Applications

This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more

HRSA Withdraws 340B Program Proposed Rule

On November 14, 2014, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) withdrew a proposed rule that would have provided guidance on a variety of topics related to the...more

The Seventh Circuit Rejects Medicaid False Claims Act Suit

The United States Court of Appeals for the Seventh Circuit affirmed the dismissal of a False Claims Act (“FCA”) case against Shopko Operating Stores, LLC, in which a former Shopko pharmacist asserted Medicaid billing...more

FDA Posts New Materials on Proposed Laboratory Developed Test (LDT) Regulatory Framework

On Friday, October 31, 2014, FDA posted on its website an audio recording, transcript, and slides from its October 23, 2014 webinar discussing the draft guidance document titled “Framework for Regulatory Oversight of...more

HRSA Abandons Plans for “Mega-Rule” for 340B Drug Pricing Program

Based on a notice posted on its Office of Pharmacy Affairs (OPA) website, the Health Resources and Services Administration (HRSA) intends to issue in 2015 proposed guidance addressing key policy issues raised by the various...more

The 340B Mega-Reg is Dead

With all due credit to the Coroner from the Wizard of Oz, like the Wicked Witch of the East crushed by Dorothy’s house, the 340B Drug Discount Program mega-reg is “not only merely dead, it’s really most sincerely dead.” And...more

Will the Mid-Term Elections Help Telemedicine Reimbursement?

Our recent survey of senior-level health care executives reinforced that lack of reimbursement remains the primary barrier to providers in adopting telemedicine services. Of our respondents, 41 percent indicated that their...more

HHS Withdraws Proposed 340B Drug Pricing Program "Mega Regs": Further Guidance Forthcoming

The Department of Health and Human Services (HHS) has withdrawn its greatly anticipated 340B Drug Pricing Program (340B Program) proposed regulations. The proposed regulations, nicknamed the 340B Program “Mega-Regs,” had been...more

Proposed Mega Rule Abandoned Under the 340B program

In very broad terms, the 340B program allows some safety-net health care providers to provide qualifying patients with affordable prescription drugs. In January, the Office of Pharmacy Affairs (OPA) of the Health Resources...more

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