Kimberly J. Gold

Kimberly J. Gold

Mintz Levin

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CMS Releases Physician Medicare Billing Data

The U.S. Department of Health and Human Services (HHS) announced on April 9th a “historic” release of Medicare payment data to provide consumers with “unprecedented transparency on the medical services physicians provide and...more

4/11/2014 - Billing CMS Healthcare HHS Medical Devices Medicare Pharmaceutical Sunshine Act

HHS Extends Medicare Coverage to Same-Sex Couples

The U.S. Department of Health & Human Services (“HHS”) announced last week that same-sex married couples can now qualify for Medicare Part A and Part B special enrollment periods and reductions in late enrollment penalties....more

4/8/2014 - DOMA HHS Medicare Same-Sex Marriage SSA US v Windsor

Unprecedented HIPAA Fine May Mean Increased Scrutiny and Penalties

Triple-S Management Corp. (“Triple-S”), a Puerto Rico-based health insurer, has been fined $6.8 million by the Puerto Rico Health Insurance Administration (“PRHIA”) following a Health Insurance Portability and Accountability...more

2/26/2014 - Data Breach Data Protection Fines Health Insurance Healthcare HIPAA PHI

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

New York’s Nonprofit Revitalization Act Becomes Law

On December 18, 2013, New York State Governor Andrew Cuomo signed the Nonprofit Revitalization Act of 2013 (the Act) into law, triggering the first overhaul of the New York Not-for-Profit Corporation Law (N-PCL) in more than...more

12/24/2013 - Charitable Donations Charitable Organizations Corporate Governance Corporate Management Executive Compensation Financial Reporting Foreign Corporations Internal Audit Functions Non-Profits

GlaxoSmithKline Announces Further Limits on Payments to Physicians and on Sales Compensation

GlaxoSmithKline (“GSK” or the “Company”) announced yesterday that it will stop paying health care professionals to promote its drug products and will no longer tie the compensation of its worldwide sales force to individual...more

12/19/2013 - GlaxoSmithKline Healthcare Professionals Pharmaceutical Physician Payments Sales Commissions

On the First Day of Privacy, The OCR Gave to Me...

Welcome to our series, “The 12 Days of Privacy” as we look to “gifts” that may be received this season and some of the big issues ahead …. Day One – - HIPAA 2014 – Where will the Audit Trail Lead? The year 2013...more

12/9/2013 - HHS HIPAA HITECH OCR OIG Privacy Laws Privacy Policy

New York Cracks Down on Executive Compensation for Not-for-Profits

Those powerful words were spoken by New York Governor Andrew M. Cuomo just over two years ago in his announcement of the formation of a task force to combat excessive executive compensation at not-for-profit corporations that...more

11/25/2013 - Andrew Cuomo Charitable Organizations Executive Compensation Healthcare Safe Harbors Sanctions

Hearing to Address HIPAA Accounting of Disclosures

The HHS Office of Civil Rights (OCR) announced that the Health Information Technology (HIT) Policy Committee’s Privacy and Security Tiger Team will hold a virtual, public hearing on Monday, September 30 from 11:45 a.m. to...more

9/26/2013 - Business Associates Covered Entities HHS HIPAA HIPAA Omnibus Rule HITECH OCR PHI

FDA Issues Final Mobile Medical App Guidance

The U.S. Food and Drug Administration (FDA) has issued long-awaited final guidance for developers of mobile medical apps. The final guidance comes more than two years after the FDA published its draft guidance in July 2011. ...more

9/24/2013 - FDA Mobile Apps Mobile Devices Telemedicine

OCR Publishes Model Notice of Privacy Practices

With the September 23, 2013 compliance date for the HIPAA Omnibus Rule only one week away, the Office for Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC) have developed...more

9/17/2013 - HIPAA HIPAA Omnibus Rule Notice of Privacy Practices Notice Requirements OCR

Massachusetts Launches New Program to Combat Provider Fraud

Last week, the Massachusetts’ Secretary of Health and Human Services, John Polanowicz, announced the launch of a new $5 million program designed to detect and prevent provider fraud, waste, and abuse in MassHealth, the...more

9/12/2013 - FMAP Fraud Healthcare Healthcare Fraud Medicaid Medicare

Texas Makes Changes to Medicaid Laws and Programs

Texas Governor Rick Perry signed a series of bills into law last week modifying some of the state’s Medicaid statutes and programs. The laws will take effect on September 1, 2013....more

6/20/2013 - CHIP Fraud Healthcare Medicaid Medicare New Legislation

Agencies Seek Comments to Inform Future Health IT Regulation

As health information technology (HIT) advancements proliferate, so too must governing regulations. Three agencies – the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information...more

6/4/2013 - FCC FDA FDASIA Health Information Technologies Public Comment Risk Assessment

FDA Delivers Its First Mobile Medical App Inquiry

The Food and Drug Administration has taken its first action against a mobile app maker for failure to obtain pre-marketing clearance. ...more

5/29/2013 - FDA FDCA Medical Devices Mobile Apps

OCR Publishes HIPAA Guides for Providers and Consumers

Understanding the complexities of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules is often a challenge for health care providers and consumers. Recognizing the widespread...more

5/2/2013 - HIPAA OCR Privacy Policy Security and Privacy Controls

Firearms Debate Triggers OCR Request for Comments

Gun violence is a hot topic in the wake of the Newtown shootings and the aftermath of last week’s Boston Marathon bombings, and now health privacy has joined the debate....more

4/24/2013 - Criminal Background Checks Firearms Gun Laws HIPAA Mental Illness NICS OCR PHI

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

The New HIPAA Omnibus Rule & Your Liability — A Detailed Review

As we have reported in this blog, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently released final regulations containing modifications to the HIPAA Privacy, Security, Enforcement, and...more

2/18/2013 - Business Associates Cloud Computing Covered Entities Data Breach ERISA Fundraisers HHS HIPAA Omnibus Rule HITECH Marketing Notice Requirements OCR PHI Privacy Rule Risk Assessment Subcontractors Training

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

OCR Releases Sample Business Associate Agreement Provisions

The Department of Health and Human Services, Office for Civil Rights (OCR) has posted on its website sample business associate agreement provisions to help covered entities and business associates comply with the new business...more

1/28/2013 - Business Associates Covered Entities Data Protection Electronic Medical Records HHS HIPAA HIPAA Omnibus Rule HITECH OCR

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

OIG Approves Hospital’s Electronic Interface Arrangement

In OIG Advisory Opinion 12-20, the OIG determined that a proposed arrangement (the “Proposed Arrangement”) by a hospital (the “Requestor”) would not constitute grounds for the imposition of sanctions under the Anti-Kickback...more

12/21/2012 - Anti-Kickback Statute Hospitals OIG Safe Harbors Sanctions

Utilizing the HIPAA audit protocols as a compliance tool By Kimberly J. Gold

Originally published in Compliance Today on December 1, 2012. ..Covered entities are now subject to privacy and security audits by OCR. ..OCR published audit protocols regarding its standards for such...more

12/6/2012 - Audits Compliance Healthcare Healthcare Professionals HHS HIPAA OCR

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