Articles and Blogs

On May 13, 2016, the Office of Civil Rights (“OCR”) of the Department of Health and Human Services (“HHS”) issued a final rule (“Final Rule”) implementing Section 1557 of the Patient Protection and Affordable Care Act (“ACA”). A copy of the Final Rule is available here. The rule is scheduled to become effective on July... READ MORE

In the May 2016 edition of Perspectives, The Joint Commission announced the end of its ban on sending patient care orders by text message effective immediately for all accreditation programs. In 2011, The Joint Commission published a set of Frequently Asked Questions (“FAQs”) prohibiting physicians or licensed independent practitioners from texting orders for patient... READ MORE

Recent updates to the Health Resources and Services Administration’s (“HRSA”) regulatory agenda indicate that HRSA has delayed the much anticipated release of its final 340B Program Omnibus Guidance (also referred to as the “mega-guidance”) to the end of 2016. HRSA has also delayed publication of a final 340B manufacturer civil monetary penalty rule and... READ MORE

On May 17, 2016, the U.S. Department of Labor (“DOL”) announced the details of its final rule under the Fair Labor Standards Act, establishing new salary thresholds for millions of traditionally exempt white collar employees. These changes will significantly impact many employers’ budgets in coming months, although not by as much or as soon as... READ MORE

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... 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... 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... 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... 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,... READ MORE

On April 27, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a much anticipated proposed rule (“Proposed Rule”) for the transition to a new Merit-Based Incentive Payment System (“MIPS”) and alternative payment models (“APMs”) pursuant to the Medicare Access and Children’s Health Insurance Program Reauthorization Act of 2015 (“MACRA”). As background, MACRA... READ MORE