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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
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
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
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
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
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 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
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FDA posted on its website an audio recording, transcript, and slides from its October 23, 2014 webinar discussing the draft guidance document titled “Framework for Regulatory Oversight of...more
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
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
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
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
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
The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical...more
During the 15th Annual Pharmaceutical Compliance Congress and Best Practices Forum on November 4, 2014, Douglas Brown, Deputy Director of the Data Sharing & Partnership Group within CMS’s Center for Program Integrity,...more
Over the last several years, several health insurers have brought antitrust claims against drug companies, contending that they were overcharged for drugs as a result of agreements reached by the drug companies in the...more
Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing...more
Earlier this year, the U.S. Department of Health and Human Services Office of Civil Rights ("OCR") announced its plan for a number of audits regarding compliance with the Health Insurance Portability and Accountability Act of...more
On Thursday, HRSA formally withdrew its much-anticipated 340B Mega-Reg from the rulemaking process, effectively abandoning its effort to overhaul existing 340B program guidance through new regulations. Commander Krista...more
On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) released its annual final rule (Final Rule) setting the payment rates and coverage policies for items and services reimbursed under the Outpatient...more
The Nokia Sensing XCHALLENGE has announced its Q3 2014 Winners. According to XPRIZE, a non-profit organization that manages public competitions to advance technological development, the Nokia Sensing XCHALLENGE was offered...more
There is resounding evidence that physicians and patients rely on the Internet—including social medial platforms—to research and communicate health information. FDA, however, has been slow to adapt even though the potential...more
On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued its final Medicare physician fee schedule rule for CY 2015 (the Final Rule), which also includes certain changes to the Sunshine Regulations. ...more
The FDA has released a new draft guidance document for industry entitled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception” (the Guidance Document), which...more
In a pair of recent cases, two California health care providers successfully warded off lawsuits arising from unauthorized data breaches of patient files. These cases illustrate that improper disclosure of electronically...more
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