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HTMLOIG Semiannual Report to Congress Shows Enforcement Number of $4.1b in Investigative Receivables
Scott S. Liebman; Loeb Loeb LLP;
Legal Alert/Article
January 29, 2015, previously published on December 2014
In issuing its report, the watchdog said that of the $4.9 billion in expected recoveries for this year, $4.1 billion came from investigative work.

 

HTMLFDA Publishes Guidance Meant to Help Firms Understand the Labeling Section Related to Patient Counseling
Scott S. Liebman; Loeb Loeb LLP;
Legal Alert/Article
January 29, 2015, previously published on December 2014
The regulator issued guidance containing recommendations meant to ensure that the “Patient Counseling Information” section of labeling is clear and useful, as well as consistent.

 

HTMLFDA Issues Proposed Regulations Requiring Electronic Distribution of Drug Labeling to Ensure Healthcare Providers Have the Most Up-To-Date Prescribing Information
Scott S. Liebman; Loeb Loeb LLP;
Legal Alert/Article
January 29, 2015, previously published on December 2014
The agency is proposing to require pharmaceutical firms to provide healthcare providers with real-time electronic updates of drug label changes, forgoing printed labels, a change the agency says is intended to ensure that healthcare professionals and patients have the most current version of...

 

HTML2014 Transitional Reinsurance Fee Reporting Deadline Extended to December 5, 2014
Keith Ranta; Jackson Lewis P.C.;
Legal Alert/Article
January 28, 2015, previously published on November 21, 2014
The Department of Health and Human Services (HHS) has announced that the 2014 deadline for reporting the number of participants covered under a health plan for purposes of paying the 2014 Transitional Reinsurance Fee has been extended from November 15, 2014 to December 5, 2014. Insurers and...

 

HTMLEEOC Announces Intent to Propose Regulations That May Harmonize ADA and GINA with ACA Wellness Program Rules
Joseph J. Lazzarotti; Jackson Lewis P.C.;
Legal Alert/Article
January 28, 2015, previously published on December 1, 2014
Since filing multiple litigations against employers concerning their wellness programs, including seeking a temporary restraining order against Honeywell International, the Equal Employment Opportunity Commission (EEOC) has faced a significant amount of push back from many U.S. companies, their...

 

HTMLCMS Released Final Rule Regarding Denying or Revoking Medicare Enrollment
Clay J. Countryman; Breazeale, Sachse & Wilson, L.L.P.;
Legal Alert/Article
January 28, 2015, previously published on December 5, 2014
On December 3, 2014, the Centers for Medicare & Medicaid Services (CMS) released a Final Rule that provides CMS discretion to deny or revoke Medicare enrollment based on certain circumstances.

 

HTMLCMS Bringing Star Ratings to Home Health
Ari J. Markenson; Duane Morris LLP;
Legal Alert/Article
January 23, 2015, previously published on December 12, 2014
The Centers for Medicare and Medicaid Services (“CMS”) issued a fact sheet on December 11th, 2014, discussing its intention to issue star ratings for Medicare certified home health agencies. The star ratings would be live in 2015.

 

HTMLClinical Trial Sponsors Can Be Liable For Inadequate Consent Forms
Philip H. Lebowitz; Duane Morris LLP;
Legal Alert/Article
January 23, 2015, previously published on December 12, 2014
Physicians acting as investigators for a clinical trial testing a new therapy are required to present to each patient or study subject a consent form, indicating that the patient understands the risks, benefits and alternatives of participating in the trial and voluntarily elects to do so. Federal...

 

HTML7th Circuit Clarifies FCA Fraud Standard
Philip H. Lebowitz; Duane Morris LLP;
Legal Alert/Article
January 23, 2015, previously published on December 5, 2014
In an opinion openly skeptical of a relator’s knowledge, the 7th Circuit Court of Appeals recently affirmed the dismissal of False Claims Act claims against a Chicago pharmacy brought by a former employee of the pharmacy. The principal claims in the case, nadyor v. Ukrainian Village Pharmacy,...

 

HTMLFda Issues Final Guidance on Discerning Device Recalls from Market Withdrawals Related to Medical Device Enhancements in Apparent Bid to Appease Industry Concern Over Draft Being Overly Broad, Lacking in Term Definitions
Loeb Loeb LLP;
Legal Alert/Article
January 23, 2015, previously published on October 2014
The regulator put out the final guidance document to ensure companies are able to clearly distinguish a recall from a market withdrawal after the draft version sparked concern and confusion throughout the industry.

 


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