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HHS OIG Adds New Authorities to the Anti-Kickback Statute and Civil Monetary Penalties Law

By: Brandon W. Shirley on February 23, 2017

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…

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Be Prepared: Submission of Breach Notifications Due to HHS by March 1, 2017

By: Stephanie T. Eckerle and Stacy Walton Long on February 23, 2017

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…

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HHS OIG Publishes New Regulations that Expand its Authority to Exclude Health Care Providers from Participation in the Program

By: Brandon W. Shirley on February 23, 2017

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…

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SAMHSA Final Rule on Confidentiality of Substance Use Disorder Patient Records

By: Stephanie T. Eckerle on February 15, 2017

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…

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Preparing Your Facility for the MOON

By: Thomas N. Hutchinson on February 15, 2017

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…

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CMS "Mid-Build" Exception Deadline and Provider-Based Growth Strategies

By: Thomas N. Hutchinson on February 6, 2017

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…

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CoreMMIS Implementation Date

February 6, 2017

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,…

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New OCR and ONC Fact Sheet Discusses When PHI May be Disclosed for Health Oversight Activities

By: Stephanie T. Eckerle on January 30, 2017

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…

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Implantable Cardiac Devices Raise Cyber-Security Concerns

By: Stephanie T. Eckerle and Stacy Walton Long on January 30, 2017

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…

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Indiana Department of Insurance Issues Bulletin on the Interest Rate for Failure to Pay Clean Claims

January 23, 2017

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…

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The OIG Issues Report on NorthShore University HealthSystem's Medicare Compliance

January 23, 2017

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…

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Long Overdue Federal Rules for Home Health Agencies Published

By: Meghan M. Linvill McNab on January 23, 2017

On January 13, 2017 CMS published a comprehensive final rule revising the conditions of participation (“COPs”) that home health agencies (“HHAs”) must abide by in order to participate in Medicare and Medicaid programs.   Through the changes to these rules, CMS seeks to achieve broad-based, measurable…

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