Stephanie Willis

Stephanie Willis

Mintz Levin

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OCR’s New Bulletin on Ensuring Privacy in Public Health Emergencies

This week, the HHS Office of Civil Rights (OCR) issued a bulletin (Bulletin) to remind covered entities and business associates that “the protections of the Privacy Rule are not set aside during an emergency.” The...more

11/13/2014 - Business Associates Covered Entities Ebola Emergency Management Plans HIPAA OCR Privacy Rule Public Interest

Fraud and Abuse Waivers for MSSP ACOs Extended Another Year

Fridays are for fraud and abuse news-related releases, yet again. Last Friday, the HHS Office of the Inspector General (OIG) released a notice (Notice) informing the public that it has delayed the release of a final rule...more

10/24/2014 - ACOs Final Rules Fraud and Abuse Healthcare Medicare Medicare Shared Savings Program OIG Waivers

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

10/16/2014 - False Claims Act Healthcare Medicare Part D Pharmaceutical Pharmacies Prescription Drugs Qui Tam

Proposed Rule Issued by OIG Realigns Its Enforcement Views with Health Care Reform Goals

Fridays never seem to be slow in the health care regulatory world. On Friday, October 3rd, the HHS Office of the Inspector General (OIG) issued a highly anticipated proposed rule (the Proposed Rule) that provides amendments...more

10/10/2014 - Ambulance Providers Anti-Kickback Statute Cost-Sharing Medicare Part D OIG Proposed Regulation Safe Harbors

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

CMS Releases MSSP and Pioneer ACO Data on Shared Savings and Losses – Where Do We Go From Here?

On September 16, 2014, the Centers for Medicare & Medicaid Services (CMS) announced key shared savings and losses results of Accountable Care Organizations (ACOs) that began participating in the Medicare Shared Savings...more

9/24/2014 - ACOs CMS Healthcare Medicaid Medicare Medicare Shared Savings Program

NIST Vetting Guidance Valuable for Health Care Organizations Seeking to Use Third-Party Apps

The mobile app and wearables market in health care is booming, most recently evidenced by Apple’s entry into the market with its widely-anticipated “HealthKit,” a purportedly secure platform that allows mHealth apps to share...more

9/17/2014 - Apple Healthcare Mobile Apps NIST Technology Telehealth Telemedicine

NIST Issues Draft Report Enumerating Risks and Protections to Consider When Evaluating Mobile Apps for Your Enterprise

As the world recovers from the excitement leading up to Tuesday’s Apple Live Event announcement of the new iPhone 6 and Apple Watch, mobile app developers are chomping at the bit to create software that leverages the new...more

9/15/2014 - Apple Fitness Health Mobile Apps NIST Popular Privacy Policy Software

New Connecticut Pharmacy Rewards Disclosure Bill Took Effect July 1

On June 12th, Connecticut governor Dannel P. Malloy signed into law ”An Act Concerning Pharmacy Rewards Programs And Protected Health Information“. The law went into effect July 1st, and applies to pharmacy retailers in the...more

7/3/2014 - HIPAA New Legislation Pharmacies PHI Retailers Rewards Programs

Five Lessons from OCR’s Report to Congress on Breaches and HIPAA Rules Compliance

Last week, the HHS Office of Civil Rights (OCR) released two reports required by the Health Information Technology for Economic and Clinical Health (HITECH) Act: (i) the Annual Report to Congress on Breaches of Unsecured...more

6/23/2014 - Data Breach Data Protection EHR Healthcare HIPAA HITECH PHI

The ONC’s Health IT Vision Plan: A Building Under Construction

The HHS Office of the National Coordinator (ONC) released its report “Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure” (the “Vision Plan”) last week to help...more

6/13/2014 - EHR Healthcare HHS HITECH Medicaid Medicare ONC

Connecticut Pharmacy Rewards Program Disclosure Bill Could Cause Headaches

The Connecticut State Senate recently passed a bill that would impose additional disclosure and consent requirements on retailers offering pharmacy rewards programs to consumers. If the bill passes the Connecticut House and...more

5/8/2014 - Disclosure Requirements HIPAA Pharmaceutical Pharmacies Rewards Programs

State Data Security Breach Notification Laws

The general definition of “personal information” or “PI” used in the majority of statutes is: An individual’s first name or first initial and last name plus one or more of following data elements: (i) Social Security number,...more

4/24/2014 - Breach Notification Rule Data Breach Data Protection

Compliance is No Joke: OCR Releases Security Risk Assessment Tool

On March 28, 2014, the Office of Civil Rights (OCR) announced the release of an online and iPad app-based security risk assessment (SRA) tool. The tool is intended to help health care providers in small to medium sized...more

4/1/2014 - Compliance HIPAA OCR Risk Assessment

Five Key Decisions for ACOs Looking to Participate in the 2015 MSSP

The Centers for Medicare & Medicaid Services (CMS) has announced the upcoming deadlines for the third round of new applications to the Medicare Shared Savings Program (MSSP). Accountable Care Organizations (ACOs) that...more

3/31/2014 - ACOs Affordable Care Act CMS Healthcare

For New Recovery Audit Contracting Cycle, CMS “RAC”s up Changes

Last month, the Centers for Medicare & Medicaid Services (CMS) announced important changes to the Recovery Audit Program. The agency had already begun the procurement process to find new Recovery Audit Contractors (RACs) in...more

3/19/2014 - CMS Home Health Care OMHA Recovery Audit

Avoid the Anti-Corruption “Blacklist:” Chinese Agency Guidance

On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more

3/5/2014 - Anti-Corruption Bribery China Healthcare Medical Devices Pharmaceutical

En Español: HHS Agencies Issue Model Notices of Privacy Practices in Spanish

Last week, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) and Office for the National Coordinator for Health Information Technology (ONC) issued model Notices of Privacy Practices (NPPs) in...more

2/24/2014 - Disclosure Requirements Healthcare Native Language Notice of Privacy Practices OCR PHI

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act (FCA) Cases

Trends & Analysis: •We have identified 23 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Only six of those cases were filed in 2013. The majority (13 cases) were filed in 2011 or 2012,...more

2/12/2014 - Anti-Kickback Statute False Claims Act Healthcare Qui Tam

Health Care Reform Goals Fail to Persuade Court in Antitrust Challenge to Acquisition

On January 24, 2014, a federal district court judge validated the trend of recent increased Federal Trade Commission (FTC) scrutiny of physician practice consolidations and acquisitions by upholding the agency’s antitrust...more

2/4/2014 - Acquisitions Antitrust Litigation FTC Healthcare Healthcare Reform

Data Breach Wall of Shame: 2013's Highlights and Lessons

Since 2009, the HHS Office for Civil Rights (“OCR”) has posted all large data breaches – those that involve 500 or more individuals – online on its so-called “Wall of Shame.” In 2013, 160 large data breaches were reported to...more

1/24/2014 - Cybersecurity Data Breach Data Protection Encryption Healthcare HHS Medical Records OCR Recording Requirements

CMS Announces 123 New ACOs; Doubles Down On Pioneer ACO Program

Accountable Care Organizations (ACOs) continue to figure big in CMS’s health care reform agenda. On December 20th, the agency’s Innovation Center published a Request for Information (Pioneer RFI) seeking input on how to...more

12/30/2013 - ACOs CMS Healthcare Healthcare Reform Medicare Shared Savings Program Request For Information

Unsealed Qui Tams Show That Government Declination is Not Always the End

Mintz Levin’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides focused analysis of four health care-related qui tam cases in which the government declined to intervene, including...more

12/5/2013 - Declination False Claims Act Healthcare Medicare Part D Off-Label Promotion Pharmaceutical Pleading Standards Qui Tam

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed Cases: November 2013

Trends and Analysis: ..We have identified 32 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only four were filed in 2013. The majority (23 cases) were filed in 2012, with the...more

12/5/2013 - Certiorari False Claims Act Healthcare Qui Tam SCOTUS

OCR Delays Required Changes to Notices of Privacy Practices for Laboratories

The HHS Office of Civil Rights (OCR) has granted certain clinical laboratories a temporary reprieve from the requirement to update their Notices of Privacy Practices (NPPs) by September 23, 2013, the deadline imposed by the...more

9/23/2013 - CLIA Data Protection Enforcement Actions HHS HIPAA HIPAA Omnibus Rule Laboratories Notice Requirements OCR Penalties

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