Health Law Advisor

In a decision with ramifications for employers in health, retail, hospitality and other industries serving the public, on October 22, 2015 in a decision, Marina Del Rey Hospital, 363 N.L.R.B. No. 22, 2015 BL 347693, the NLRB confirmed the legality of policies barring employees from the premises when not on duty, which contain an exception permitting off-duty employees to be on the premises as members of the public, e.g., as a patient or a visitor.  The Board found, however, that enforcement of the facially neutral policy to certain employment restrict protected activity constitutes ...

One of the issues with which we often grapple in the telehealth space is the relative lack of availability of studies and data when compared to other areas of the health care sector.  Telehealth is relatively young and therefore has not had the time to build a voluminous body of data and evidence.  But things are changing.  Many stakeholders are doing exemplary work in telehealth research, and stakeholders like the Department of Veterans Affairs have longstanding evidence regarding the efficacy of telehealth.  However, it’s a more recent document that has caught my attention.

A ...

On November 24, 2015, in United States ex rel. Purcell v. MWI Corp., No. 14-5210, slip op. (D.C. Cir. Nov. 24, 2015), the District of Columbia Circuit Court of Appeals ruled that federal False Claims Act ("FCA") liability cannot attach to a defendant's objectively reasonable interpretation of an ambiguous regulatory provision. While outside of the health care arena, this decision has implications for all industries exposed to liability under the FCA.

In Purcell, the government alleged that false claims had been submitted as a result of certifications made by defendant MWI ...

A recent survey conducted by the Robert Graham Center, the American Academy of Family Physicians, and Anthem caught my attention. The survey was conducted to gauge the attitudes of primary care physicians regarding telehealth.  And the results make for interesting reading— providing great insight into how certain providers view and use telehealth. What struck me most is that while great progress has been made in the rate of telehealth adoption among providers, we still have a way to go. According to the survey report, state legal and regulatory issues, reimbursement, and provider ...

House Republican leaders introduced legislation on Monday, finalizing a two-year budget agreement between Congressional leaders and the White House. This legislation is currently being considered and may be up for a vote as early as Wednesday on the bipartisan budget deal.

Hospitals should note the language in Section 603 (which is on pages 35-39 of the draft bill) codifies the definition of a "provider-based off-campus hospital outpatient department" (PBD HOPD) as a location that is not on the main campus of a hospital and is located more 250 yards from the main campus.  The section ...

Every now and then a confusing knot of rules gets streamlined and untangled. That recently occurred in New Jersey, when the state’s Supreme Court adopted a new  unified Mental Health  Service Provider – Patient Privilege, to replace the state’s existing patchwork of privileges which offer varying, and sometimes inconsistent, degrees of protection to communications between mental healthcare professionals and their patients. The new privilege, codified as NJ Evidence Rule 534 (“Rule”) will go into effect on July 16, 2016.  The Rule applies to legal proceedings in New ...

Employment Law This Week - a new video program from Epstein Becker Green - has a story this week on how the Supreme Court has cleared the way for the Department of Labor’s home care worker wage rule.

The high court recently denied a stay of the D.C. Circuit’s decision, and the new rule extending Fair Labor Standards Act protections to most home care workers will go into effect November 12, 2015. While the Department will not begin full enforcement until January 1, 2016, the new regulation will be immediately enforceable by private individuals and attorneys.

Constance Wilkinson, Member of Epstein Becker Green, will co-present on a webinar on "340B Program and the Proposed Mega-Guidance" on October 22, 2015, from 2:00 - 3:00 p.m. ET.

With recent publication of the long-awaited proposed "Mega-Guidance," the federal 340B Drug Discount Program ("the 340B Program") is poised for significant changes. This webinar describes the 340B Program's historical background, practices, and challenges that resulted in the proposed policies and goals reflected in the Mega-Guidance. In addition to learning about the history of the 340B Program ...

On September 28, 2015, the Centers for Medicare & Medicaid Services ("CMS") issued a request for information ("RFI") seeking comments on two key components of the physician payment reform provisions included in the Medicare Access and CHIP Reauthorization Act of 2015 ("MACRA"), the law enacted on April 16, 2015, repealing the sustainable growth rate formula used to update payment rates under the Medicare Physician Fee Schedule.  The RFI was originally open for a 30-comment period.  However, CMS has announced that it is extending the comment period for an additional 15 days.  Comments ...

On Wednesday, October 14, 2015, the U.S. District Court for the District of Columbia (the "Court"), Judge Rudolph Contreras, vacated the Health Resources and Services Administration's ("HRSA") interpretive rule on Orphan Drugs ("the Interpretative Rule") as "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law."^[1]  As a result of the ruling, pharmaceutical manufacturers are not required to provide 340B discounts to certain types of covered entities for Orphan Drugs, even when the drugs are prescribed for uses other than to treat the rare ...