Articles and Blogs

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integrity concerns at drug manufacturing sites around the world, the U.S. Food and Drug Administration (FDA) issued a draft guidance on April 15 (Guidance) to outline its recommendations for the creation and handling of data in accordance with current good manufacturing practice (CGMP)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

CMS Issues Proposed Rule on Quality-Based Payment Program On April 27, CMS released a notice of proposed rulemaking to update how Medicare payments are linked to the quality and cost of care provided to beneficiaries. Hall Render has published a summary of the key provisions on its website. The proposal is the first step in…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 permanently…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 HIPAA,…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 Review…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 MCO’s…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 associate…Read More