C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

Ashley N. Southerland

Ashley N. Southerland

Ashley N. Southerland is a counsel in the Washington, D.C., office of Crowell & Moring, where she practices in the firm’s Litigation and Health Care groups.

Ashley’s litigation practice spans various industries, including health care, higher education, and hospitality. She represents domestic and multinational companies in complex litigation, as well as in arbitrations involving contractual disputes. In her health care practice, Ashley counsels private health care entities—including hospitals, health care providers, and managed care organizations—in a wide range of state and federal regulatory matters involving the False Claims Act, the physician self-referral law (Stark Law) and the Anti-Kickback Statute, and Medicare and Medicaid compliance. Ashley is also engaged in counseling private universities in the areas of compliance and litigation risk management.

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FDA Advances Flexibility-Based Framework for Digital Health and AI

Posted in FDA, Health IT, Medicaid, Medicare
The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation. During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and… Continue Reading

The Freight Train Gathers Steam: An Update on the Federal Response to the Opioid Crisis

Posted in FDA, Medicaid, Medicare
Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response… Continue Reading

Liberating Data to Transform Value-Based Care: MyHealthEData, Blue Button 2.0, and Price Transparency

Posted in Health IT
On March 6, 2018 at the Healthcare Information and Management Systems Society (HIMSS) 2018 conference, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new initiative furthering the current Administration’s focus on value-based care and increasing patient access to healthcare data. The initiative — called MyHealthEData — will be led by the… Continue Reading

ONC Releases New Guidance on Electronic Health Record Vendor Contracting

Posted in Health IT
On September 26, 2016, the Office of the National Coordinator for Health Information Technology (ONC) released guidance, entitled EHR Contracts Untangled, to help providers navigate the complexities of electronic health record (EHR) vendor contracting. The guidance breaks down important considerations for selecting EHR systems, and provides strategic pointers – including sample contract language – to… Continue Reading

The Rise of the One-Stop Shop? ONC Outlines Four Mechanisms to Help Providers Compare Certified Health IT Products

Posted in Health IT
Earlier this month, the Office of the National Coordinator for Health Information Technology (ONC) released a report to Congress on the feasibility of creating tools to help providers compare and select certified health IT products. As part of the Medicare Access and CHIP Reauthorization Act (MACRA), Congress required ONC to conduct a study to examine… Continue Reading

ONC Announces New EHR Certification Criteria

Posted in EHR, HIPAA & Privacy
Continuing to usher in a new wave of EHR technology changes, on September 11, 2014, the Office of the National Coordinator for Health Information Technology (“ONC”) adopted the “2014 Edition Release 2” final rule, which provides alternative criteria and approaches for the voluntary certification of heath information technology. The final rule, effective October 14, 2014[1],… Continue Reading

New HHS Rules Focus on Increased Flexibility, Improvements in the World of EHR Technology

Posted in EHR, HIPAA & Privacy
On September 4, 2014, the Department of Health and Human Services (“HHS”) published a final rule modifying the Medicare and Medicaid Electronic Health Record (“EHR”) Meaningful Use Incentive Program. The modification brings welcome change, allowing increased flexibility while also assuaging several provider concerns. The new rule, effective October 1, 2014, comes in response to numerous… Continue Reading

Thousands may lose Affordable Care Act health coverage absent residency and income verification

Posted in Health Care Reform & ACA
The Centers for Medicare & Medicaid Services (“CMS”) recently announced that it had identified and contacted more than 300,000 people to obtain proof of their citizenship or legal residency status. Failure to provide this documentation by September 5 could result in these individuals losing their Affordable Care Act (“ACA”) health coverage, effective September 30. This… Continue Reading

HIPAA Hammer Comes Down: HHS OCR Announces Settlements in Laptop Thefts

Posted in HIPAA & Privacy
The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced in an April 22, 2014, press release that two separate entities—Concentra Health Services (“Concentra”) and QCA Health Plan, Inc. (“QCA”)—collectively have paid almost $2 million to resolve potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA)… Continue Reading

GAO Reports HITECH Act Implementation Remains Stymied

Posted in HIPAA & Privacy
In a March 2014 report, the United States Government Accountability Office (GAO) identified major and on-going challenges with the practical implementation of the Health Information Technology for Economic and Clinical Health (HITECH) Act. The HITECH Act provides funding to promote the adoption and “meaningful use” of health information technology (HIT), as well as certified electronic… Continue Reading

Obama Administration Changes Course on Sequester of Cost-sharing Subsidies for Low-Income Enrollees in Exchange Plans

Posted in Exchanges, Health Care Reform & ACA
The Obama Administration recently announced a policy change indicating that the Fiscal Year (FY) 2015 budget sequester will not cut cost-sharing subsidies for low-income enrollees in Affordable Care Act (ACA) health plans. According to a March 10, 2014 Office of Management and Budget (OMB) report detailing the federal government’s sequestration-based spending reductions for FY 2015,… Continue Reading

IRS Promulgates Clarifying Regulations Regarding Abstainer Penalties Under the ACA

Posted in Exchanges, Health Care Reform & ACA, Medicaid, Tax
On January 27, 2014, the Internal Revenue Service (IRS) issued proposed regulations (“Proposed Regulations”, available here) clarifying the penalties imposed on nonexempt persons who fail to maintain minimum essential coverage as required by Internal Revenue Code (Code) Section 5000A. Very generally, Code Section 5000A requires nonexempt persons to either (1) maintain minimum essential coverage, or (2)… Continue Reading