Kate Stewart

Kate Stewart

Mintz Levin

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Office for Human Research Protections Releases Draft Guidance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Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in...more

10/30/2014 - Draft Guidance Ethics Informed Consent Market Research Medical Research Standard of Care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

4/30/2014

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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