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Paige Jennings

Paige Jennings is an associate in Covington’s Washington office. She works with the firm’s Federal–State Programs, Health Care, Antitrust, and Litigation practice groups. Ms. Jennings joined the firm after a number of years working on health policy matters in the government and private sectors. Prior to earning her law degree and Master of Public Affairs, she worked in the U.S. Senate for over four years, advising Senators John Breaux and Tom Carper on health and social policy matters. Ms. Jennings later handled federal health policy issues at WellPoint, Inc. During law school, she worked with the U.S. Office of Management and Budget during consideration of the Affordable Care Act, and with the Federal Trade Commission for then-Chairman Jon Leibowitz.

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HHS Announces Enforcement Discretion Over the Implementation of Interoperability Final Rules Due to COVID-19 Public Health Emergency

On April 21, 2020, the Department of Health and Human Services (“HHS”) announced that, as a response to the COVID-19 public health emergency, it will exercise enforcement discretion to “permit compliance flexibilities” regarding the implementation of the interoperability final rules issued on March 9th, 2020.  This joint announcement was made by the Office of the … Continue Reading

HHS Finalizes Interoperability Rules

On March 9, 2020, the Department of Health and Human Services (HHS) issued two final rules aimed at improving patient access to electronic health information (EHI), as well as the standardization of modes of exchange for EHI.  The rules, which were issued by the Office of the National Coordinator for Health Information Technology (ONC) and … Continue Reading

Vote on HHS Secretary Nomination Expected as Early as this Week; Nomination Hearings Included Little Discussion of Health IT

The full Senate could vote as early as this week on the nomination of Rep. Tom Price (R-GA) to be Secretary of the U.S. Department of Health and Human Services (HHS). In January, two Senate Committees held hearings on Rep. Price’s nomination. These hearings focused largely on Rep. Price’s stance on repeal of the Affordable … Continue Reading

GAO Recommends that HHS Strengthen Privacy and Security Guidance and Oversight

Earlier this week the Government Accountability Office released a report critiquing the U.S. Department of Health and Humana Services’ (HHS) oversight of and guidance related to health information security and privacy. (The report is available here.) GAO cited the increasing incidence of hacking and other breaches, which affected over 113 million health records in 2015, … Continue Reading

ONC Report to Congress Identifies Gaps in Oversight of Privacy and Security of mHealth Technologies and Health Social Media

Earlier this month the U.S. Department of Health and Human Services (HHS), Office of the National Coordinator for Health Information Technology (ONC), released a report to Congress highlighting “large gaps” in policies and oversight surrounding access to and security and privacy of health information held by certain “mHealth technologies” and “health social media.” mHealth technologies … Continue Reading

Senate HELP Committee Marks Up Precision Medicine, Other “Cures” Bills

Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a final mark-up of legislation comprising the Committee’s counterpart to the House-passed 21st Century Cures Act.  The HELP Committee approved five bills including S. 2713 to advance the development of “precision medicine” through research and data sharing.  We have reported on the President’s precision medicine … Continue Reading

FDA Regulatory Science Priorities Address Use of Data, Health Information Technology

On October 20, 2015, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released its top ten Regulatory Science Priorities for FY 2016 to facilitate improvements in the safety and effectiveness of medical devices and accelerate innovation. Several of the priorities would harness health information technology or health data to … Continue Reading

Senate Approves Bill to Ease Meaningful Use Requirements In Ambulatory Surgery Setting

Last week, the U.S. Senate unanimously approved a bill that would ease federal requirements that professionals seeing patients at ambulatory surgery centers (ASCs) “meaningfully use” certified electronic health records (EHRs). The measure would sunset after certified EHR technology is applicable to the ASC setting.… Continue Reading

CMS Releases Additional Medicare Data; Expands Access to Data for “Commercial” Purposes

Last week, the Centers for Medicare & Medicaid Services (CMS) made additional Medicare data publicly available and expanded the permissible uses of other data. For the third consecutive year, CMS released hospital-specific data on inpatient and outpatient charges, Medicare payments, and utilization for common Medicare procedures.  CMS also released similar data on physicians and other … Continue Reading

CMS Releases Part D Prescriber-Level Data as Part of Larger Transparency Effort; Some Stakeholders Express Concern

On April 30, 2015, CMS released a massive new dataset with information on the over one billion prescription drug claims made by 36 million Medicare beneficiaries enrolled in the Part D drug benefit in 2013. CMS stated that the release was part of the Obama Administration’s larger effort to increase transparency in the healthcare system.… Continue Reading

House Cures Draft Includes Provisions to Expand Access to Data, Facilitate Research

On April 29, 2015, members of the U.S. House Energy and Commerce Committee released a revised discussion draft of the 21st Century Cures Act (“Cures”). The draft bill includes a number of provisions intended to facilitate drug, biologic, and medical device discovery and development through greater collection and dissemination of data and the use of … Continue Reading

The Joint Commission Issues Health IT-Related Patient Safety Alert

The Joint Commission, an independent, non-profit organization that accredits and certifies health care organizations, recently issued a Sentinel Event Alert to identify patient safety risks related to the use of health information technology and to recommend actions that hospitals and other accredited organizations should consider.… Continue Reading

Moving to the Cloud: Some Key Considerations for Healthcare Entities

Healthcare providers, health plans, and other entities are increasingly utilizing cloud services to collect, aggregate, store and process data.  A recent report by IDC Health Insights suggests that 80 percent of healthcare data is expected to pass through the cloud by 2020.  As a substantial amount of healthcare data comprises “personal information” or “protected health … Continue Reading

New Accountable Care Organization Initiative Includes Expanded Medicare Telehealth Coverage

On March 10, 2015, the Centers for Medicare & Medicaid Services (CMS) announced the “Next Generation” Medicare Accountable Care Organization (ACO) model, which builds on the Pioneer ACO Model and the Medicare Shared Savings Program.  In what some consider to be an indication of increasing openness to the expansion of telehealth, CMS will allow Next … Continue Reading

Draft 21st Century CURES Bill Includes Telehealth Provisions

Telehealth legislation circulated earlier this month has been included in the draft House 21st Century CURES bill.  Groups commenting on the telehealth provision have generally supported the effort to expand telehealth services under Medicare, but are divided about whether the measure goes far enough. The “Advancing Telehealth Opportunities in Medicare” subtitle of the CURES bill … Continue Reading

President Obama Announces Precision Medicine Initiative, Presses for Cybersecurity Legislation

This year’s State of the Union address included little explicit discussion of health IT, but did highlight two areas that could have significant implications for health IT: the President announced a new “Precision Medicine Initiative” and also urged Congress to pass legislation to combat cyber attacks and prevent identity theft. While the address was scant … Continue Reading

PCORI Announces $150 Million to Support Continued Development of Clinical Research Network

The Patient-Centered Outcomes Research Institute (PCORI), the nonprofit corporation tasked with advancing comparative clinical effectiveness research, recently released two funding announcements to support Phase II of its effort to create a National Patient-Centered Clinical Research Network, or PCORnet. PCORnet is intended to be a national network providing wide access to health data for clinical outcomes … Continue Reading

Congress Declines to Extend ICD-10 Transition Deadline… For Now

Stakeholders are divided over the current October 1, 2015 deadline for ICD-10 implementation, with some asking Congress to again delay the deadline and others pressing to stick with a 2015 transition.  Both sides have raised cost as one justification for their positions: implementation may cost individual small providers up to $227,000, while further delays could cost … Continue Reading

ONC Names Acting Deputy National Coordinator

The Office of the National Coordinator for Health Information Technology (ONC) has named Dr. Jon White to replace Dr. Jacob Reider as the Acting Deputy National Coordinator.  Dr. White joined ONC in October on part-time detail from the Agency for Healthcare Research and Quality (AHRQ).  Since then, he has served as interim head of ONC’s Office … Continue Reading

CMS Designates Chief Data Officer to Lead New Data and Analytics Office

The Centers for Medicare & Medicaid Services (CMS) announced in late November that it has designated the agency’s first “Chief Data Officer” to lead a new Office of Enterprise Data and Analytics (OEDA).  Niall Brennan will serve as the agency’s CDO and his office will oversee “improvements in data collection and dissemination as the agency strives to … Continue Reading

CMS Expands Medicare Telehealth Coverage and Continues Support for Chronic Care Management Coverage; Notes Limitations of Current Law

As part of the October 31, 2014 final rule updating payment polices under the Medicare physician fee schedule, CMS continued its policy of allowing payment for non-face-to-face chronic care management services and also expanded the list of Medicare-covered telehealth services.  However, CMS declined to provide coverage for other proposed telehealth services, and the agency noted the limits … Continue Reading

CMS Reopens Meaningful Use Hardship Exception Application Period

On October 7, 2014, the Centers for Medicare & Medicaid Services (CMS) reopened the submission period for hardship exception applications to allow eligible professionals and hospitals to avoid 2015 meaningful use penalties.  Penalties for failing to demonstrate meaningful use of Certified Electronic Health Record Technology (CEHRT) were applied beginning October 1, 2014 for hospitals, and … Continue Reading