Penalties Dept. of Health and Human Services

News & Analysis as of

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

Are you ready for Section 1557’s notice requirements?

This is a reminder that beginning October 16, 2016, Covered Entities (as defined below) are required to comply with certain notice requirements under Section 1557 of the Affordable Care Act (“ACA”). Section 1557 of the ACA...more

Health Law Insights Newsletter - Issue 13

McCarter & English, LLP’s Health Care Group presents Issue 13 of the Health Law Insights, which discusses the latest legal issues in the health care industry. - Failure to Update Business Associate Agreement Results in...more

Manatt on Health Reform: Weekly Highlights - September 2016 #2

CMS denies Ohio’s Medicaid 1115 waiver request citing the State’s premium proposal; HHS will use 2015 risk corridors collections for remaining 2014 payments; and Alabama closes its Medicaid budget shortfall....more

HHS Inflation Adjustment Rule Hikes CMPs Across Department Programs

The Department of Health and Human Services (HHS) is increasing maximum civil monetary penalty (CMP) amounts applicable to HHS agencies and programs, in compliance with the Federal Civil Penalties Inflation Adjustment Act...more

You Received a Health Insurance Marketplace Notice from HHS – Now What?

Take a deep breath. The HHS Health Insurance Marketplace Notice (the “Notice”) may seem to be a nuisance, but it does not necessarily mean that you will be subject to employer shared responsibility penalties....more

New ADA and GINA Wellness Regulation Changes Complicate Wellness Program Compliance Analysis and Risks

Wellness programs should all be reviewed considering the Americans with Disabilities Act (“ADA”) and the Genetic Information Nondiscrimination Act (“GINA”) regulatory changes because noncompliance with the new requirements do...more

Corporate Investigations & White Collar Defense - October 2015

"Wherefore Art Thou Due Process?" Part III - Why it matters: It is time for another installment in our continuing "Wherefore Art Thou Due Process?" coverage into the ongoing constitutional challenges to the SEC's...more

The ERISA Litigation Newsletter - August 2015

Editor's Overview - As the summer draws to a close, this month's Newsletter previews three cases that the U.S. Supreme Court already has agreed to hear that ought to be of particular interest to ERISA plan sponsors and...more

Florida Nursing Home Pays Record Settlement to Resolve Federal Anti-Kickback Case

In a recent case Hebrew Homes Health Network, Inc. and its former president and executive Director agreed to pay $17 million to settle allegations that Hebrew Homes violated the federal anti-kickback statute. According to the...more

Employer Paid Individual Health Insurance Policies Create the Potential for Significant Penalties, But Limited Relief Is Available

Despite guidance from the Internal Revenue Service (“IRS”), the Department of Labor (“DOL”) and the Department of Health and Human Services (“HHS”) indicating the prohibition of the practice under the Affordable Care Act...more

DHHS Blunder Could Cost Millions! “Oops I Did It Again!”

We can add one more “oops” to the Department of Health and Human Services (DHHS) repertoire of “oopses.” I am reminded of Captain Edward Smith when he banged the Titanic into an iceberg. Talk about an “oops” moment. Not to...more

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

Business Associate Definition Expanded and HHS Empowered to Impose New Civil Fines

Long-awaited omnibus regulations (Omnibus Rule) adopted earlier this year by the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) made significant modifications impacting “business associates” to...more

WellPoint agrees to pay $1.7M in HIPAA penalties: what this tells you

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has announced that WellPoint, Inc. agreed to pay $1.7 million to settle potential violations of the Health Insurance Portability and...more

Shasta Regional Medical Center Pays $275,000, Enters into Corrective Action Plan to Resolve Alleged HIPAA Privacy Rule Violations...

Shasta Regional Medical Center (Shasta) has agreed to pay $275,000 and enter into a corrective action plan (CAP) with the U.S. Department of Health and Human Services Office for Civil Rights (OCR) to resolve allegations that...more

Final HIPAA Regulations Impact Group Health Plans

The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) sets forth rules to protect the privacy and security of individuals’ health information that is held by “covered entities,” such as group health plans....more

Health Care Reform Update: Proposed Rules Issued On 90-Day Limit Placed On Waiting Periods For Health Coverage

Beginning in 2014, the Affordable Care Act of 2010 (the "Act") will prohibit group health plans and group health insurers from imposing waiting periods greater than 90 days of employment....more

Cloud Storage Providers Storing Protected Health Information May Be Obligated to Comply with HIPAA Regulations

A recently issued government rule may unknowingly create significant liability and legal risk for many technology enterprises. The expanded definition of "business associates" and related interpretations by the Department of...more

Burr Alert: Employer Obligations Under New HIPAA Rules

With all of the attention garnered by healthcare reform, it would be easy to overlook the new HIPAA rules (the "Rules") applicable to covered entities under HIPAA, which include employer group health plans. Compliance with...more

Highlights of the Omnibus HIPAA/HITECH Final Rule

On January 25, 2013, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS) published the long-awaited omnibus final regulation governing health data privacy, security and enforcement (Omnibus...more

The Affordable Care Act’s “Play Or Pay” Mandate: How It Works

The Affordable Care Act added the so-called “Play or Pay” mandate or “Employer Shared Responsibility” provisions to the Internal Revenue Code (the Code). Starting in 2014, certain employers may be subject to a penalty tax,...more

A Detailed Analysis of Changes to HIPAA and the Implications for Healthcare Providers and Others in the Healthcare Industry: HIPAA...

Changes to the HIPAA Enforcement Rule - Background: On October 30, 2009, HHS issued an interim final rule revising the Enforcement Rule to incorporate provisions of the HITECH Act. The NPRM then proposed a number of...more

IRS Releases Proposed Regulations on the Affordable Care Act's Play or Pay Mandate

On January 2, 2013, the Department of Treasury and Internal Revenue Service (collectively “IRS") published proposed regulations ("Proposed Regulations") on the Affordable Care Act's employer shared responsibility provisions,...more

HHS Publishes Long-Awaited Final Omnibus Rules for HIPAA

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) published today the final regulations for the HIPAA Privacy, Security, Enforcement and Breach Notification Rules (the Omnibus Rules). The Omnibus...more

30 Results
|
View per page
Page: of 2
JD Supra Readers' Choice 2016 Awards

"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.
×