Kate Stewart

Kate Stewart

Mintz Levin

Contact  |  View Bio  |  RSS

Latest Publications

Share:

At Long Last, CMS Issues Final Rule for Lab Fee Schedule Changes

Last Friday afternoon CMS released its eagerly anticipated final rule (the Final Rule) implementing the Protecting Access to Medicare Act of 2014 (PAMA), which, together with the Final Rule, will make sweeping changes to the...more

6/20/2016 - Clinical Laboratories CMS Final Rules Laboratory Developed Tests MCLFS Medicare PAMA Provider Payments

Check Your Inbox: OCR Continues to Verify Entity Contact Information for Phase 2 HIPAA Audits

Covered Entities need to continue to check their inboxes for emails from the HHS Office for Civil Rights (“OCR”) requesting verification of contact information in connection with Phase 2 of the HIPAA Audit Program. OCR...more

5/23/2016 - Audits Business Associates Covered Entities HHS HIPAA OCR

Justices Grapple with Limits of False Claims Act Liability in Implied Certification Cases

Last week the Supreme Court heard oral argument in a False Claims Act (“FCA”) case in which the Court is considering the validity of the so-called implied false certification theory. This theory attaches FCA liability when a...more

4/27/2016 - False Claims Act (FCA) False Implied Certification Theory Federal Contractors Implied Certification Medicaid SCOTUS Universal Health Services Inc v United States ex rel Escobar

Ready or Not, It’s Time For Phase 2 HIPAA Audits

On March 21st, the HHS Office for Civil Rights (“OCR”) officially launched Phase 2 of the HIPAA Audit Program. Covered Entities and Business Associates need to be prepared for these audits and be on the lookout for emails...more

3/22/2016 - Business Associates Covered Entities HHS HIPAA Audits HITECH OCR

Drug Company Payments and Prescribing Patterns Linked, Massachusetts Is An Outlier

As reported in yesterday’s Boston Globe, compared to national averages, Massachusetts physicians are less likely to receive payments or items of value from pharmaceutical companies and less likely to be heavy prescribers of...more

3/21/2016 - Medicare Part D Pharmaceutical Industry Physicians Prescribing Authority Prescription Drugs Provider Payments

Don’t Neglect Your Business Associate Agreements!

As we have repeatedly emphasized on this blog, HIPAA Covered Entities must ensure that they have compliant business associate agreements (“BAAs”) in place with all of their business associates and must ensure that they have...more

3/18/2016 - Business Associates Corrective Actions Covered Entities HIPAA OCR PHI Risk Assessment Settlement

Ransomware Strikes California Hospital – Could You Be Next?

In a chain of events that should be a wake-up call to any entity using and storing critical health information (and indeed, ANY kind of critical information), Hollywood Presbyterian Medical Center (“HPMC”) has announced that...more

2/23/2016 - Electronic Medical Records FBI Hackers HIPAA Hospitals Popular Ransomware

Hollywood Presbyterian Concedes to Hacker’s Demands in Ransomware Attack

In a chain of events that should be a wake-up call to any entity using and storing critical health information, Hollywood Presbyterian Medical Center (“HPMC”) has announced that it paid hackers $17,000 to end a malware attack...more

2/19/2016 - Cyber Attacks Electronic Medical Records Hackers Health Care Providers HIPAA Hospitals OCR Ransomware

Latest OCR Enforcement Action: Underbed Storage is Not Appropriate for PHI

Recent enforcement actions by the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) have highlighted that, not surprisingly, Covered Entities should not leave medical records in a...more

2/5/2016 - HHS HIPAA Home Health Care OCR PHI Privacy Policy

HIPAA and Health Care Data Privacy – 2015 Year in Review

As the year winds down, we look back with a mixture of nostalgia and queasiness on the major Health Insurance Portability and Accountability Act (HIPAA) events that defined 2015. Incredibly large data breaches became...more

12/11/2015 - Anthem Insurance Cyber Attacks Data Breach HIPAA HITECH OCR PHI

Agencies Extend Comment Period on Proposed Changes to Clinical Research Rules

Those wishing to comment on revisions to the Federal Policy for Protection of Human Subjects (known as the “Common Rule”) could add a 30-day comment period extension to the things they were grateful for at this year’s...more

11/30/2015 - Clinical Laboratories Clinical Trials Comment Period HHS Medical Research The Common Rule

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

43 Results
|
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×