Health Law Advisor

In response to multiple requests, the Centers for Medicare and Medicaid Services ("CMS") have extended the deadline for comments on the proposed changes to the home health conditions of participation ("CoPs").  Home health providers and other interested stakeholders now have until 5:00 p.m. EST on January 7, 2015 to submit comments to CMS.

The proposed changes to the CoPs were published on October 9, 2014[1] and represent the most significant changes to the home health CoPs in seventeen years.  According to CMS, the new CoPs are intended to better reflect modern home health practice by ...

Regarding the Supreme Court’s Integrity Staffing Solutions v. Busk opinion, issued today, our colleague Michael Kun at Epstein Becker Green has posted “Supreme Court Holds That Time Spent in Security Screening Is Not Compensable Time” on one of our sister blogs, Wage & Hour Defense.

Following is an excerpt:

In order to prevent employee theft, some employers require their employees to undergo security screenings before leaving the employers’ facilities. That is particularly so with employers involved in manufacturing and retail sales, who must be concerned with ...

Our colleaguesEmily E. Bajcsi, Clifford E. Barnes, Marshall E. Jackson Jr., and Serra J. Schlanger recently published a client alert on legislative and regulatory efforts impacting the hospice and home health industries:

• President Obama signed the Improving Medicare Post-Acute Care Transformation Act of 2014 ("the IMPACT Act") into law;
• The Centers for Medicare and Medicaid ("CMS") published the Medicare Home Health Prospective Payment System final rule for calendar year 2015 ("Final Rule"); and
• CMS published proposed changes to the home health conditions of participation ...

On Wednesday, December 10, 2014 colleague Stuart M. Gerson of Epstein Becker Green's Litigation and Health Care and Life Sciences practices in the firm's Washington, DC and New York offices will join a panel discussion on "The Manay Faces of the Affordable Care Act."  Christopher Farella of Epstein Becker Green's Litigation and Labor and Employment practices in the firm's Newark office will serve as moderator.

Issues to be addressed include:

• State of play with respect to various aspects of the ACA, particularly the employer mandate, including a discussion of recent case law.
• How ...

The 2014 outbreak of the Ebola Virus Disease ("Ebola") is the largest in history and continues to affect multiple countries in West Africa. Although reports of new Ebola cases in the U.S. – potential or confirmed – have slowed down in recent weeks, the Centers for Disease Control and Prevention ("CDC") and its various domestic and international partners continue their efforts to prevent further transmission of Ebola in the U.S. as well as abroad. Earlier this week, in fact, the CDC released two new pieces of guidance regarding treatment of Ebola that will be of particular interest ...

Last week, FDA launched Drug Trials Snapshot, a pilot program intended to provide consumers with information about the sex, age, race and ethnicity of clinical participants for six drugs approved in May and June 2014.  This pilot is intended to solicit feedback on the content, format and usefulness of the information provided in advance of an expansion of the program to include all new molecular entities subject to an approved NDA beginning in 2015.

The Drug Trials Snapshot website was developed by FDA in response to the requirements in Section 907 of FDASIA that FDA: 1) report to ...

My colleague Lee T. Polk authored Epstein Becker Green’s recent issue of its Take 5 newsletter.   This Take 5 features five considerations suggesting the advantages of employee benefit plans as programs that are beneficial to both employers and employees.

1. Tax Aspects of Qualified Retirement Plans Can Save Money For Both Employers and Employees
2. The Benefits of a Contractual Claims Limitation Period
3. The Benefits of a Contractual Venue Selection Clause
4. The Standard of Judicial Review in the Context of Top Hat Plan Benefit Disputes
5. Fiduciary Exception to the Attorney-Client ...

On November 13, 2014, the Health Resources and Services Administration ("HRSA") announced its plans to abandon the much anticipated "mega-reg" amid questions concerning HRSA's rule-making authority.  The "mega-reg" was expected to provide much needed clarity to the 340B drug discount program (the "340B Program") by addressing, among other things, the definition of an eligible patient, compliance requirements for contract pharmacy arrangements, hospital eligibility, and criteria for hospital off-site facilities.

HRSA submitted draft regulations to OMB in April 2014 ...

On November 13, 2014, the Food and Drug Administration ("FDA") announced a proposed study on spousal influence on consumer understanding and responses to direct-to-consumer prescription drug advertisements.  FDA notes that consumers are often thought of as individual targets for prescription drug advertisements, without considering the social contexts in which many treatment decisions are made.  For example, FDA notes that when spouses view an ad together a spouse "may influence their partner by expressing concern about risk and sides effects that might occur ...

Epstein Becker Green's slides from the "Eye on Ebola: A Discussion About the Health Regulatory, Risk Management, and Labor and Employment Issues Impacting Health Care Providers" webinar is featured on the American Hospital Association's Ebola Preparedness Resources - click here.

The November 17 webinar addressed the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases, and featured 4 fantastic speakers.

• Bruno Petinaux, M.D., Associate Professor, Co-Chief of the Emergency Management Section ...