Articles and Blogs

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integrity concerns at drug manufacturing sites around the world, the U.S. Food and Drug Administration (FDA) issued a draft guidance on April 15 (Guidance) to outline its recommendations for the creation and handling of data in accordance with current good manufacturing practice (CGMP)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

On April 21, 2016, the Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced a $2.2 million settlement with a New York hospital (“Hospital”) stemming from unauthorized patient filming by ABC’s NY Med television show. In what OCR called an egregious disclosure of protected health information (“PHI”) in violation of... READ MORE

In an interim final rule published in the Federal Register on April 21 (“Rule”), the Centers for Medicare & Medicaid Services (“CMS”) amended its regulations to allow PPS hospitals located in urban areas to obtain a “412.103” urban to rural reclassification and also be reclassified for wage index purposes by the Medicare Geographic Classification... READ MORE

On May 6, 2016, CMS will publish its new Medicaid managed care rule, which will permit states to require Medicaid MCOs1 to make enhanced payments to targeted hospitals, physicians and nursing facilities for a limited number of years. This is a departure from current practice in which states are prohibited from directing a Medicaid... READ MORE

On April 19, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) reached a settlement in the amount of $755,000 with a North Carolina orthopedic clinic (“Clinic”) for failing to execute a business associate agreement with a third-party vendor. This is OCR’s second settlement this year related to business... READ MORE

On April 18, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released its Hospital Inpatient Prospective Payment System and Long Term Acute Care Hospital Proposed Rule Issues for Fiscal Year 2017, which are set to be published on April 27, 2016. CMS included a proposed rule for implementing the Notice of Observation Treatment... READ MORE