Health Law Advisor

My colleague, Adam C. Abrahms, published a Management Memo blog post that will be of interest to many of our readers: “Worse Than Feared … NLRB Reports First Month of Ambush Election Rules Yields More Petitions, Dramatically Quicker Elections.”

Following is an excerpt:

A couple weeks ago we provided anecdotal reports from several NLRB Regional Directors that after one month the new Ambush Election Rules union elections were being held in considerably less time, with the Regional Directors claiming elections were being scheduled between 25-30 days.  Last week ...

Our colleagues James A. Boiani and John S. Linehan at Epstein Becker Green wrote an advisory on the U.S. Food and Drug Administration's ("FDA") introduction of new plans to constrain animal drug compounding with the release of its Draft Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances. In this advisory, the parameters of the Draft Guidance are outlined, which suggests that a dramatic shift in the FDA's enforcement approach may be underway and provides insight into the FDA's enforcement priorities and its interpretation of the applicable ...

In a unanimous decision announced May 26, the U.S. Supreme Court, in Kellogg Brown & Root Services, Inc. v. United States ex rel. Carter, 2015 BL 163948, U.S., No. 12-1497, 5/26/15, ruled that the Wartime Suspension of Limitations Act ("WSLA") applied only to criminal charges and not underlying civil claims in times of war. Thus, the WSLA – which suspends the statute of limitations when the offense is committed against the Government - cannot be used to extend the statute of limitations in cases such as those brought under the False Claims Act ("FCA"). This ruling reversed a decision of ...

On April 2, 2015, Thomas Galassi, Director of the Directorate of Enforcement for OSHA, sent a memorandum to all Regional Directors announcing that the agency's National Emphasis Program on Nursing and Residential Care Facilities would be extended until replaced by updated guidance or removed by the agency.  Mr. Galassi went on to state that, because the health care industry reports more work-related injuries and illnesses than any other general industry,

By Alan J. Arville, Constance A. Wilkinson and Selena M. Brady

The House of Representatives Energy and Commerce Committee ("the Committee") circulated draft language to include in its 21^st Century Cures legislation earlier this week to reform the 340B drug discount program (the "340B Program"). Although the draft 340B language was pulled from the legislation yesterday, the language proposed provides insight into what future legislative reform may include. The draft language, if adopted, would have a substantial impact on all 340B Program stakeholders, including, covered ...

My colleagues Steven M. Swirsky and Evan J. Spelfogel published a Management Memo blog post that will be of interest to many of our readers: “Regional Directors Report Data on The NLRB’s Amended Election Rules After One Month – Court Challenges Continue.”

Following is an excerpt:

May 14th marked the one-month anniversary of the effective date of the NLRB’s Amended Representation Election Rules (“amended rules”).  That day, the Regional Directors for NLRB Regions 2 (New York, NY), 22 (Newark, NJ), and 29 (Brooklyn, NY) discussed their ...

As we reported, last November, voters in Massachusetts approved a law granting Massachusetts employees the right to sick leave, starting on July 1, 2015.  The law provides paid sick leave for employers with 11 or more employees and unpaid sick leave for employees with 10 or fewer employees. While the law set forth the basics, many of the details, which have differentiated the various sick leave laws across the country, were not previously specified (e.g., minimum increments of use, frontloading, documentation).  The Massachusetts Attorney General’s Office (“AGO”) has set ...

On March 3, 2015, the New Jersey State Board of Nursing ("Board") issued a comprehensive set of proposed amendments, repeals and new rules pertaining to Delegation and Certification; Homemaker-Home Health Aides.  The changes broaden the authority of registered professional nurses ("RNs") and permit RNs to train, and then delegate tasks to licensed practical nurses ("LPNs"), certified home health aides ("CHHAs") and other assistive persons (collectively "assistants").  This certainly seems like a positive step for the Home Health industry and its patients.  Nurses will be able ...

On March 24, 2015, the House of Representatives Energy and Commerce Health Subcommittee^[1] (the "Subcommittee") held a 340B Program hearing with testimony from the Deputy Administrator of Health Resources and Services Administration ("HRSA"), the Director of the Office of Pharmacy Affairs ("OPA") of HRSA,[2] the Director of Health Care of the Government Accountability Office ("GAO"), and Assistant Inspector General of the Office of Evaluation and Inspection of the U.S. Department of Health and Human Services ("HHS") Office of Inspector General ("OIG").

The purpose of the ...