Kate Stewart

Kate Stewart

Mintz Levin

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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 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 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

CMS Officially Launches National Physician Payment Transparency Program Website

The Centers for Medicare & Medicaid Services (“CMS”) recently launched the National Physician Payment Transparency Program: OPEN PAYMENTS website, which provides Sunshine Act compliance resources, including Fact Sheets and...more

4/16/2013 - CMS GPOs Physician Payments Sunshine Act Transparency

IRS Provides Additional Guidance for Non-Profit Hospitals

Last week, the IRS issued a Notice of Proposed Rulemaking (“2013 Proposed Rule”) regarding the community health needs assessment (“CHNA”) requirement of 26 U.S.C. § 501(r)(3) (added to the Internal Revenue Code by the...more

4/10/2013 - Affordable Care Act CHNA Compliance Healthcare Hospitals Penalties

CMS Publishes Final Sunshine Act Rule Creating New Regulatory Landscape for Physician-Manufacturer Interactions

Originally published in the Health Care Fraud Report, 17 HFRA 219, on 03/06/2013. The final rule (the ‘‘Final Rule’’) implementing the Physician Payments Sunshine Act (‘‘Sunshine Act’’), published in the Federal...more

3/7/2013 - CMS Drug Manufacturers Joint Purchasing Programs Physicians Sunshine Act

Report Highlights Record-Breaking Year of Enforcement for HHS and DOJ

Yesterday, the Department of Health and Human Services (“HHS”) and the Department of Justice (“DOJ”) released their Annual Report for the Health Care Fraud and Abuse Control Program (the “Program”). The report highlights the...more

2/13/2013 - DOJ Enforcement Actions Fraud Fraud and Abuse HHS Medicaid Medicare

CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

2/5/2013 - CMS Compliance Continuing Medical Education Data Collection Drug Manufacturers Enforcement GPOs Medicaid Medical Devices Medical Supplies Payment Records Physicians Reporting Requirements Sunshine Act

Let the Collection and Reporting Begin: CMS Publishes Final Sunshine Act Regulations

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

2/4/2013 - Biologics CME CMS Data Collection Drug Manufacturers GPOs Medical Devices Pharmaceutical Reporting Requirements Stark Law Sunshine Act

HIPAA Omnibus Rule Reference Chart

Mintz Levin is pleased to provide this section-by-section analysis of the HIPAA Omnibus Rule. The chart lists provisions of the proposed privacy, security and enforcement rules mandated by the Health Information...more

1/23/2013 - Business Associates Covered Entities Data Breach Data Protection HIPAA HIPAA Omnibus Rule HITECH Notice Requirements PHI

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