HIPAA, as amended by HITECH, imposes significant requirements on those persons or entities who qualify as a business associate (BA) as a result of their access to protected health information (PHI) in the performance of services on behalf of a covered entity (CE).
For example, a BA could be a third…
The Health and Human Services Office of Inspector General (“OIG”) recently finalized new regulations (“Regulations”) impacting the anti-kickback statute (“AKS”) safe harbors and civil monetary penalties law (“CMPL”). Specifically, the Regulations expanded the exceptions and safe harbors under the…
Did your company have a HIPAA breach affecting less than 500 individuals in calendar year 2016 that has not yet been reported to HHS? If so, the deadline for submission of any breach notifications to HHS is March 1, 2017.
HIPAA requires that covered entities maintain a log or other documentation of…
The Health and Human Services Office of Inspector General (“OIG”) finalized Regulations on January 12, 2017, that revise and clarify Federal authorities governing a health care provider’s participation in and exclusion from a Federal health care program, i.e., Medicare and Medicaid. These changes…
On January 18, 2017, the Substance Abuse and Mental Health Services Administration (“SAMHSA”) published a Final Rule that updates the confidentiality requirements and provisions to improve the exchange of information of patients seeking treatment for a substance abuse disorder of 42 C.F.R. Part 2…
On January 27, 2017, CMS issued final guidance regarding implementation of its Medicare Outpatient Observation Notice (MOON) program. The MOON informs all Medicare beneficiaries (both traditional fee-for-service and Medicare Advantage) when they are an outpatient receiving observation services, and…
The Bipartisan Budget Act of 2015 (“Section 603”) made waste of many hospitals’ plans for off-campus provider-based practice locations. Notwithstanding, a final reprieve for certain provider-based facilities is the 21st Century Cures Act’s “mid-build” exception, which creates an exception to…
On January 30, 2017, Indiana’s Family and Social Services Administration (“FSSA”) published Bulletin BT201710 announcing that the Indiana Health Coverage Programs (“IHCP”) have set Monday, February 13, 2017, as the new implementation date for replacing the current information system, IndianaAIM,…
The U.S. Department of Health and Human Services Office of Civil Rights and The Office of the National Coordinator for Health Information Technology recently published a new fact sheet entitled “Permitted Uses and Disclosures: Exchange for Health Oversight Activities.” This fact sheet provides…
The FDA continues to monitor and assess potential cybersecurity vulnerabilities associated with radio frequency (“RF”) enabled implantable devices. The FDA recently reviewed St. Jude Medical’s Merlin@home Transmitter and software patch – an implantable cardiac device – to determine any…
On January 3, 2017, the Indiana Department of Insurance (“Department”) issued Bulletin 235, titled “Interest Rate for Failure to Pay a Clean Claim,” clarifying the interest rate calculated on clean claims pursuant to Indiana Code Sections 27-8-5.7 and 27-13-36.2 (“Clean Claims Laws”). Under the…
On January 9, 2017, the Office of Inspector General for the Department of Health and Human Services (the “OIG”) released a thirty-two page report detailing its review of NorthShore University HealthSystem’s (“NorthShore”) Medicare compliance during 2013 and 2014, as part of a series of hospital…
