Stephanie Willis

Stephanie Willis is a member of the firm's Health Care Group in Crowell & Moring's Washington, D.C. office. She counsels health care clients in matters involving regulatory issues, including fraud and abuse compliance, participation in new health care reform initiatives under the Affordable Care Act (ACA), as well as Certificate of Need (CON) and licensure matters. She has also advised clients on compliance with laws and regulations governing health IT initiatives and health care privacy and security, including the Health Insurance Portability & Accountability Act (HIPAA).

Firm/Organization: Crowell & Moring LLP

Blogs: C&M Health Law, Data Law Insights, Government Contracts Legal Forum

Latest Articles

C&M Health Law

FDA Seeks Comment on Clinical Decision Support Software Guidance and Issues Policy Updates on its Oversight Authority Regarding Medical Software and Apps

By Jodi G. Daniel, Stephanie Willis & Shaina Vinayek

October 23, 2019

In September 2019, the Food & Drug Administration (FDA) issued a new draft “Clinical Decision Support Software” guidance for public comments, which are due December 26, 2019. Concurrently, the agency published updates to four related guidance documents centered on regulation of digital health software products along with a consolidated summary titled “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act,”[1] but is not…

C&M Health Law

OMB Concludes Review of Proposed Rules for Modernizing Physician Self-Referral and Anti-Kickback Regulations

By Troy A. Barsky & Stephanie Willis

October 4, 2019

As of October 3, 2019, the Office of Management and Budget completed its review of the proposed rules for “modernizing and clarifying” the Physician Self-Referral Regulations and revising the safe harbors under the Anti-Kickback Statute and rules regarding the Beneficiary Inducement Civil Monetary Penalties Law. These regulations were the subject of two Requests for Information (RFIs) issued by the Centers for Medicare & Medicaid (CMS) and the HHS Office of the Inspector General (OIG) in…

C&M Health Law

New Proposed Rules on Confidentiality of Substance Use Disorder Data Would Address Care Coordination and Law Enforcement Challenges

By Jodi G. Daniel, Stephanie Willis, Brandon C. Ge & Maya Uppaluru

August 28, 2019

HHS’s Substance Abuse and Mental Health Services Administration (“SAMHSA”) proposed updated rules to clarify the scope of perceived barriers to sharing information regarding treatment for substance use disorders (SUDs) among providers, with research entities, and for law enforcement purposes. The proposed changes to the 42 C.F.R. Part 2 (“Part 2”) regulations appear in two Notices of Proposed Rulemaking (“NPRMs”), which are also summarized in a Fact Sheet. These proposals are part of HHS’s…

C&M Health Law

Allscripts Close to Reaching Deal with DOJ for Health IT Certification, Anti-Kickback Statute, and HIPAA Issues

By Jodi G. Daniel, Stephanie Willis & Maya Uppaluru

August 16, 2019

Electronic health record (EHR) vendor Allscripts recently disclosed on an earnings call that it has reached a tentative agreement with the Department of Justice (DOJ) to pay $145 million to settle an investigation into the regulatory compliance of one of its recent acquisitions, Practice Fusion. This news, combined with DOJ’s other recent successful enforcement actions against EHR companies, represents a trend and should be a warning that compliance is a priority when it comes health…

C&M Health Law

Sunshine Act/Open Payments Regulatory Changes in the 2020 Physician Fee Schedule

By Stephanie Willis & Alice Hall-Partyka

August 12, 2019

The Centers for Medicare and Medicaid Services (“CMS”) has included proposed changes to the implementing regulations for the Physician Payments Sunshine Act (“Sunshine Act”) as part of its proposed 2020 Physician Fee Schedule. The proposed regulatory changes fundamentally expand the scope of the Sunshine Act and will require reporting entities to make substantial updates to their payment tracking policies and procedures. Entities that are required to report payment data under the Sunshine Act should…

C&M Health Law

Podcast: Private Equity Investing in Health Care

By Lex Eley, Stephanie Willis, Joe Records & Payal Nanavati

July 24, 2019

In the latest episode of Payers, Providers, and Patients – Oh My!, Lex Eley and Stephanie Willis talk with Joe Records and Payal Nanavati about private equity investment in the health care industry. Subscribe to Payers, Providers, and Patients – Oh My! at: PodBean | SoundCloud | Apple Podcasts…

C&M Health Law

HIPAA Spring Cleaning! Tidying Up Penalty Limits and FAQs on Patients’ Right of Access

By Jodi G. Daniel & Stephanie Willis

May 15, 2019

The HHS Office of Civil Rights (“OCR”) closed out the month of April with some updates to HIPAA civil monetary penalty (“CMP”) limits and clarifications to OCR’s stance on the Privacy Rule’s application to transfers of electronic protected health information (“ePHI”) to third-party applications and application programming interfaces (“APIs”). Differential CMP Caps Based on Enforcement Discretion Under the current HIPAA Enforcement Rule, HHS employs a four-tier level of culpability scale in line with the HITECH…

C&M Health Law

Government Affairs – The Progress of Telehealth Bills in Congress

By Traci Vitek, Jim Flood & Stephanie Willis

November 16, 2018

The Centers for Medicare & Medicaid Services (CMS) recently proposed a rule to allow Medicare Advantage plans to expand telehealth benefit coverage. (See alert for more detail) This proposed rule implements the statutory provisions in section 50323 the Bipartisan Budget Act of 2018. What you might not know, however, is that the Bipartisan Budget Act of 2018 is only one of many legislative vehicles by which advocates for telehealth expansion have been able to move…

C&M Health Law

2019 Physician Fee Schedule Rule Modifies Stark Regulations to Reflect Statutory Changes

By Troy A. Barsky, Meredith Parnell & Stephanie Willis

November 7, 2018

On November 1, 2018, the Centers for Medicare & Medicaid Services (“CMS”) filed the pre-publication version of the CY 2019 Physician Fee Schedule Final Rule (“2019 PFS Final Rule”). Within this massive publication, CMS finalized two regulatory changes affecting the exceptions at 42 CFR § 411.357 to the Physician Self-Referral Law (also known as the “Stark Law”) for compensation arrangements. The 2019 PFS Final Rule reconciles the regulations with the statutory changes made to the…

C&M Health Law

Digital Health Updates in the 2019 Physician Fee Schedule (PFS) Rule

By Jodi G. Daniel, Stephanie Willis & Maya Uppaluru

November 6, 2018

CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to collaborate on chronic care management business models in the fee-for-service market. Virtual Check-Ins CMS finalized the creation of a new code to reimburse providers for brief “check-in” services conducted using communications technology by creating HCPCS code G2012, defined as “[b]rief communication technology-based service, e.g. virtual check-in.”…

Stephanie Willis

FDA Seeks Comment on Clinical Decision Support Software Guidance and Issues Policy Updates on its Oversight Authority Regarding Medical Software and Apps

OMB Concludes Review of Proposed Rules for Modernizing Physician Self-Referral and Anti-Kickback Regulations

New Proposed Rules on Confidentiality of Substance Use Disorder Data Would Address Care Coordination and Law Enforcement Challenges

Allscripts Close to Reaching Deal with DOJ for Health IT Certification, Anti-Kickback Statute, and HIPAA Issues

Sunshine Act/Open Payments Regulatory Changes in the 2020 Physician Fee Schedule

Podcast: Private Equity Investing in Health Care

HIPAA Spring Cleaning! Tidying Up Penalty Limits and FAQs on Patients’ Right of Access

Government Affairs – The Progress of Telehealth Bills in Congress

2019 Physician Fee Schedule Rule Modifies Stark Regulations to Reflect Statutory Changes

Digital Health Updates in the 2019 Physician Fee Schedule (PFS) Rule

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