Kate Stewart

Kate Stewart

Mintz Levin

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Latest Publications


What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

10/23/2015 - Certificates of Compliance Civil Monetary Penalty CLIA Clinical Laboratory Testing CMS Diagnostic Tests FDA Healthcare HHS Hospitals Laboratories Laboratory Developed Tests Medicaid Medicare Sanctions

CMS Publishes Long-Awaited PAMA Proposed Rule

On September 25, 2015, the Centers for Medicare & Medicaid Services (CMS) announced publication of the proposed rule (the “Proposed Rule”) implementing substantial changes to the Medicare Clinical Laboratory Fee Schedule...more

9/29/2015 - Clinical Laboratories CMS Comment Period Cost-Sharing Data Collection Diagnostic Tests Medicaid Medicare Medicare Part B MPFS PAMA Proposed Regulation Reimbursements Reporting Requirements

Back to School – HIPAA 101

After a summer that saw major data breaches at the Office of Personnel Management and UCLA Health System, this fall is a great time to take your organization back to school on HIPAA compliance and data security. Here are...more

8/27/2015 - Business Associates C-Suite Executives Cybersecurity Data Breach Data Privacy Data Protection Data Security Employee Training HIPAA OCR ONC Security Risk Assessments

Telehealth Roundup: Federal Bill Seeks to Expand Medicare Use of Telehealth; Delaware and Connecticut Update Telemedicine Laws

On July 7th, the House introduced much anticipated bipartisan telehealth legislation. The Medicare Telehealth Parity Act of 2015, introduced by Representative Mike Thompson (D-CA) and co-sponsored by Representatives Gregg...more

7/14/2015 - CMS Health Care Providers Health Insurance Healthcare Healthcare Reform Medicaid Medicare Patients Pending Legislation Physicians Telehealth Telemedicine

Injunction Blocks Implementation of Texas Telemedicine Regulations

Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that...more

6/5/2015 - Antitrust Litigation Health Care Providers mHealth NC Board of Dental Examiners v FTC Prescription Drugs Sherman Act State Action Doctrine State Action Immunity Telemedicine

ONC Releases Privacy and Security Guidance Geared Toward Small Providers

The HHS Office of the National Coordinator for Health Information Technology (“ONC”) recently released a new and improved version 2.0 of their Guide to Privacy and Security of Electronic Health Information. This revamped...more

5/8/2015 - Business Associates Electronic Medical Records Electronically Stored Information Health Information Technologies HHS HIPAA OCR PHI Security Risk Assessments

States Move to Impose Limits on Biosimilar Drug Substitution

In early April, Colorado joined multiple other states in passing a biosimilar substitution law that addresses the circumstances under which an FDA-approved interchangeable biosimilar product may be substituted for the...more

4/28/2015 - Biologics Biosimilars FDA Medicaid Medicare Pharmaceutical Industry Prescription Drugs

HIPAA Settlement Continues to Emphasize the Importance of Security Policies and Procedures

A recently announced settlement between Anchorage Community Mental Health (“ACMHS”) and the U.S. Department of Health & Human Services Office for Civil Rights (“OCR”) emphasizes, once again, the importance of compliance with...more

12/10/2014 - Data Protection Healthcare Facilities HIPAA OCR Patient Privacy Rights PHI Popular Security Rule Settlement

CMS Announces Plan for Reporting Returned Sunshine Act Payment Data

On October 30, 2014, the Centers for Medicare and Medicaid Services (“CMS”) announced the procedure for applicable manufacturers and group purchasing organizations (“GPOs”) to report payment and ownership information that was...more

10/31/2014 - CMS GPOs Manufacturers Open Payments Reporting Requirements Sunshine Act

Office for Human Research Protections Releases Draft Guidance

On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in...more

10/30/2014 - Draft Guidance Ethics Informed Consent Market Research Medical Research Standard of Care

Cliff Notes from the Joint OCR/NIST HIPAA Security Conference

As a service to our readers, we have distilled last week’s joint HHS Office of Civil Rights (OCR) and National Institute of Standards in Technology (NIST) conference, “Safeguarding Health Information: Building Assurance...more

10/1/2014 - Encryption HHS HIPAA NIST OCR Risk Assessment Training

Federation of State Medical Boards Releases Interstate Licensure Compact

As previously reported by the team from ML Strategies, one of the many telehealth developments to watch this year has been the Federation of State Medical Board’s (FSMB) Interstate Licensure Compact. On September 5, the...more

9/11/2014 - Cross-Border FSMB Licenses Licensing Rules Physicians

CMS Re-Opens Open Payments System

As my colleague Brian Dunphy previously reported, CMS temporarily closed the Open Payments system earlier this month. Open Payments is the online system through which pharmaceutical and device manufacturers covered by the...more

8/19/2014 - CMS Healthcare Inpatient Prospective Payment System (IPPS) Open Payments Sunshine Act

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

7/9/2014 - CMS Medicaid Medical Devices Medicare Pharmaceutical Industry Physician Medicare Reimbursements Physician Payments Physicians Prescription Drugs Proposed Regulation Reporting Requirements

As Sunshine Act Reporting Deadline Looms, CMS Issues Additional Guidance

With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for...more

6/12/2014 - CMS Deadlines GPOs Healthcare Medicaid Medicare Sunshine Act Transparency

Federation of State Medical Boards Passes Model Telemedicine Policy

On April 26, 2014, the Federation of State Medical Boards (“FSMB”) adopted a Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine (the “Model Policy”). The Model Policy addresses many...more


Tri-Agency Health IT Report Issued

Today, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework...more

4/4/2014 - FDA Healthcare Medical Devices Prescription Drugs TRICARE

More Open Questions About Open Payments Under the Sunshine Act

Last week, the Centers for Medicare & Medicaid Services (“CMS”) clouded the process for pharmaceutical and medical device manufacturers, and group purchasing organizations (“GPOs”), to register and submit reports under the...more

2/11/2014 - CMS GPOs Healthcare Medical Devices Pharmaceutical Industry Sunshine Act

OCR Proposes HIPAA Amendments to Address Gun Violence

As we previously reported, President Obama has made it a priority to improve the National Instant Criminal Background Check System (“NICS”). Last week, more than eight months after the issuance of a advance notice of...more

1/8/2014 - Firearms Gun Laws HIPAA OCR PHI Privacy Rule

Physician Groups Seek Sunshine Act Changes

Seventy-four state and federal physician organizations, including the American Medical Association, recently asked the Centers for Medicare & Medicaid Services (“CMS”) to exclude textbooks and peer-reviewed medical journal...more

11/1/2013 - CMS Medical Devices Pharmaceutical Industry Reporting Requirements Sunshine Act

#DoNoHarm: Rhode Island Issues Social Media Guidance for Physicians

As health care providers continue to try to navigate the world of social media, the Rhode Island Board of Medical Licensure and Discipline (the “Board”) has issued policy guidelines (the “Guidelines”) to address the use of...more

10/29/2013 - Ethics Physicians Social Media

CMS Continues To Issue Guidance On Sunshine Act Reporting

Three weeks after the commencement of data collection under the Physician Payment Sunshine Act (the “Act”), the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance to assist applicable manufacturers...more

8/23/2013 - CMS Data Collection GPOs Medicaid Medicare Physician Payments Sunshine Act

The Countdown Begins – Sunshine Act Data Collection

With the August 1 deadline for data collection under the Physician Payments Sunshine Act (the “Act”) looming, CMS recently released two mobile applications (“Apps”) to help physicians and industry track payments and transfers...more

7/23/2013 - CMS Data Collection Deadlines Healthcare Manufacturers Medicaid Medicare Physician Payments Reporting Requirements Sunshine Act

CMS Conducts First Call on Physician Payments Sunshine Act Implementation

In anticipation of the start of data collection under the Physician Payments Sunshine Act, the Centers for Medicare & Medicaid Services (“CMS”) continues to issue guidance on data collection and reporting in an effort to...more

5/28/2013 - CMS Data Collection GPOs Physician Payments Reporting Requirements Sunshine Act

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