Krysten Rosen Moller

Krysten Rosen Moller

Krysten Rosen Moller practices in the areas of health care, litigation, pharmaceutical investigations, and white collar defense and investigations. Ms. Rosen Moller primarily helps pharmaceutical and medical device companies with internal investigations, and civil and criminal investigations by the DOJ, FDA, HHS, and other agencies, relating to fraud, marketing, kickbacks, manufacturing practices, and false claims. Ms. Rosen Moller also provides advice on developments in, and compliance with, health care laws.

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CMS Marks Success with Fraud Prevention System’s “Big Data” Effort

Over the past five years, the Centers for Medicare & Medicaid Services (“CMS”) has used “big data” and predictive analytics approaches to fight fraud, waste, and abuse in the Medicare fee-for-service program. According to a recent post on the official CMS blog, the Fraud Prevention System’s “big data” effort has given CMS the ability to … Continue Reading

CMS Launches Streamlined Application for Meaningful Use Hardship Exceptions

On January 22, 2016, the Centers for Medicare & Medicaid Services (“CMS”) announced the launch of a new, streamlined application process for providers and hospitals seeking a hardship exception from financial penalties for failing to meet meaningful use electronic health record requirements.   According to CMS, “[t]he streamlined hardship applications reduce the amount of information that … Continue Reading

Senators Request Information from HHS About Medical Identity Theft Efforts

Last week, the chairmen and ranking members of the Senate Committee on Health, Education, Labor, and Pensions and the Senate Committee on Finance sent a letter to Andy Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services (“CMS”), and Jocelyn Samuels, Director of the Health and Human Services (“HHS”) Office for Civil Rights … Continue Reading

Report Outlines Plan for Precision Medicine Database

In a 107-page report, released last week, the White House set forth its plan to create and manage a database containing 1 million or more Americans’ medical records in furtherance of the Precision Medicine Initiative. As announced by President Obama during his 2015 State of the Union Address, the Precision Medicine Initiative was launched “to … Continue Reading

Comments Requested on Draft Guide on Securing Electronic Health Records on Mobile Devices

The National Cybersecurity Center of Excellence (“NCCoE”) has released a draft for public comment of the first guide in a new series of publications “that will show businesses and other organizations how to improve their cybersecurity using standards-based, commercially available or open-source tools.” The guide discusses how to secure electronic health records on mobile devices. … Continue Reading

American Medical Informatics Association Report Makes Recommendations for EHR Systems

On May 28, 2015, a panel from the American Medical Informatics Association (“AMIA”) published an eleven-page “Report of the AMIA EHR 2020 Task Force on the Status and Future Direction of EHRs.”  Recognizing that current problems in EHR use “are complex” and that “[s]olving these problems will require regulatory stability, the development of an acceptable … Continue Reading

ONC Data Brief Describes Positive Trends in the Adoption of EHR Systems

In a recently released Data Brief, the Office of the National Coordinator for Health Information Technology (ONC) described trends in adoption of Basic EHR and certified EHR in non-federal acute care hospitals from 2008 to 2014.  “Basic EHR represents a minimum use of core functionality determined to be essential to an EHR system.”  “A certified … Continue Reading

Study Finds That Majority of Health-Related Websites Share Personal Information With Third-Parties

A study published in the March 2015 issue of Communications of the ACM (Association for Computing Machinery) revealed that 91% of health-related websites initiated some type of HTTP request (HTTP is a request/response protocol, by which, for example, a computer sends a request for a file and the web server sends back a response) to … Continue Reading

Federal Health IT Strategic Plan 2015-2020 Open for Comment

On December 8, 2014, the U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) issued the Federal Health IT Strategic Plan 2015-2020.  “The Strategic Plan represents a coordinated and focused effort to appropriately collect, share, and use interoperable health information to improve health care, individual, community and … Continue Reading

Recovery Act Reviews Outlined in HHS OIG’s Work Plan for Fiscal Year 2015 Focus on EHR Incentive Payments

On October 31, 2014, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Work Plan for fiscal year 2015.  Appendix B of the Work Plan outlines OIG’s plans for continued oversight of HHS agencies’ use of American Recovery and Reinvestment Act of 2009 (Recovery Act) funds.… Continue Reading

HHS Secretary Names Members for Health Information Technology Policy Committee and Health Information Technology Standards Committee

On November 4, 2014, Health and Human Services (HHS) Secretary Sylvia M. Burwell named a new member to the Health Information Technology Policy Committee (HITPC) and renewed appointments for three members of the Health Information Technology Standards Committee (HITSC).… Continue Reading

AMA Recommends Improvements to Meaningful Use Program

On October 14, 2014, the American Medical Association (AMA) outlined its vision for the Electronic Health Record (EHR) Meaningful Use (MU) Program in a letter to the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology.  Despite the MU program’s achievements since its creation in 2009, … Continue Reading
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