Articles and Blogs

On May 9, 2016, the Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 16-06, addressing a proposed arrangement whereby a health system (“Health System”) would wholly own the requesting group purchasing organization (“GPO”), as well as approximately one percent of the GPO’s members (“Proposed Arrangement”). OIG concluded that the Proposed…Read More

On May 3, 2016, an administrative law judge struck down an employer’s computer use policy as violating employees’ rights to engage in concerted activity. (CAESARS ENTERTAINMENT CORPORATION d/b/a RIO ALL-SUITES HOTEL AND CASINO and INTERNATIONAL UNION OF PAINTERS AND ALLIED TRADES, DISTRICT COUNCIL 15). This decision comes shortly after the National Labor Relations Board (“NLRB”) General…Read More

Ways and Means Committee Holds Hearing on MACRA Implementation On May 11, the House Ways and Means Subcommittee on Health hosted CMS Acting Administrator Andy Slavitt to discuss the administration’s implementation plan for the Medicare Access & CHIP Reauthorization Act of 2015 (“MACRA”). At the hearing, Slavitt and members discussed the first MACRA-related proposed regulation,…Read More

On May 2, 2016, the U.S. Railroad Retirement Board (“RRB”) issued an Interim Final Rule (“Interim Final Rule”) significantly increasing its civil monetary penalties under the False Claims Act (“FCA”) and the Program Fraud Civil Remedies Act (“PFCRA”). Specifically, the RRB implemented minimum and maximum penalties of $10,781 and $21,563 per claim, respectively, to be effective…Read More

In the first big win in more than 10 years for hospitals over the Federal Trade Commission (“FTC”) in a litigated hospital merger challenge, U.S. District Judge John E. Jones III of the Middle District of Pennsylvania ruled against the FTC, denying their request for a preliminary injunction to temporarily block the merger between Penn…Read More

The U.S. Equal Employment Opportunity Commission (“EEOC”) recently published resource documents on two hot topics in the labor and employment world: bathroom access for transgender employees and leaves of absence for disabled workers. The EEOC notes that its resource documents do not create new policy, are not voted on by the Commission and are only…Read More

The Centers for Medicare & Medicaid Services (“CMS”) published a final rule in the May 4, 2016 Federal Register, updating fire safety standards for certain types of facilities (“Final Rule”). In the Final Rule, CMS is adopting the 2012 edition of the Life Safety Code (“2012 LSC”) with certain exceptions and other fire safety standards….Read More

In response to a recent rise in data integrity concerns at drug manufacturing sites around the world, the U.S. Food and Drug Administration (FDA) issued a draft guidance on April 15 (Guidance) to outline its recommendations for the creation and handling of data in accordance with current good manufacturing practice (CGMP) requirements for drugs, set…Read More

Brady Working on Bill to Reverse Some Site-Neutral Pay Cuts On May 2, House Ways and Means Chairman Kevin Brady (R-TX) announced his intention to introduce bipartisan legislation that exempts some off-campus hospital outpatient departments from the site-neutral payment cuts that were part of the Bipartisan Budget Act of 2015. According to Brady, the exemption…Read More

On Tuesday, April 5, the Federal Trade Commission (“FTC”) released a new web-based tool for developers of health-related mobile apps. The tool asks mobile application developers questions about the mobile app’s function, the type(s) of data that the app collects and the service(s) that the app offers to end-users. The new tool then guides mobile…Read More