Dept. of Health and Human Services

The United States Department of Health and Human Services is a federal executive department established in 1953, as part of the Department of Health, Education and Welfare. The Agency became independent in 1980... more +
The United States Department of Health and Human Services is a federal executive department established in 1953, as part of the Department of Health, Education and Welfare. The Agency became independent in 1980 and was renamed The Department of Health and Human Services at that time. HHS is charged with protecting and improving the health of the American population, as well as providing essential services.    less -
News & Analysis as of

Physician Group to Pay $750,000 to Settle a HIPAA Violation

In August 2012, a Physician Group—comprising of nearly 20 physicians—reported its HIPAA breach to HHS, which resulted from a laptop bag containing the employee’s laptop and a computer server backup being stolen from an...more

Agencies Release Proposed Overhaul of the Common Rule

On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the...more

CERCLA: ATSDR Proposes Updated Toxicological Profile for 13 Perfluoroalkyls

On September 2, 2015, the U.S. Department of Health and Human Services' (HHS) Agency for Toxic Substances and Disease Registry (ATSDR), in accordance with guidelines developed by ATSDR and the U.S. Environmental Protection...more

The Affordable Care Act After King v. Burwell: With Chaos Avoided in the Near Term, What Does the Future Hold For Health Reform?

On June 25, 2015, the U.S. Supreme Court ended the latest legal challenge to the Affordable Care Act (“ACA”) with its 6–3 ruling in King v. Burwell. With Chief Justice Roberts writing for the majority, the Supreme Court held...more

Long-Awaited Notice of Proposed Rulemaking for Federal Policy for the Protection of Human Subjects Released

On September 2, 2015, the Department of Health and Human Services released the long-awaited Notice of Proposed Rulemaking seeking comment on proposed revisions to the Common Rule, aimed at modernizing, strengthening, and...more

$750,000 Settlement Agreement Reiterates Importance of HIPAA Security Rule Compliance

On September 2, 2015, the U.S. Department of Health and Human Services ("HHS") announced that it had entered into a Settlement Agreement with an Indiana-based medical practice for alleged violations of the Health Insurance...more

Outside Counsel Should Handle Healthcare.gov Subsidy Appeals

Here’s the coming dilemma: let IRS assess employer mandate taxes based on errant Healthcare.gov subsidy certifications or appeal those errors to prevent those assessments.  “Where’s the dilemma?” you say.  Here:  once you...more

HRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public Comment

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA...more

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

St. Elizabeth’s Medical Center Pays $218,400 to Settle Alleged HIPAA Security Case Stemming from Use of Cloud-Based Document...

Alleged HIPAA Violations Resulted from Medical Center’s Failure to Risk Assess Internet-Based Document Sharing Application and Inadequate Breach Response. The US Department of Health and Human Services (HHS) Office for...more

OIG Issues Advisory Opinion No. 15-12: Free Home Health Provider Visits Do Not Violate Anti-Kickback Statute

The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a new advisory opinion finding that free introductory visits (the “Introductory Visits”) for patients offered by a home health...more

Blog: HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the...more

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

A summary and analysis of HRSA's proposed 340B program guidance

On August 28, 2015, the US Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published its long-awaited, if still only proposed, 340B program guidance (Proposed Guidance). 80 Fed....more

Employee Benefits Developments August 2015

Certain Closely Held For-Profit Employers Need Not Provide Women’s Contraceptive Services. Under the ACA, non-grandfathered group health plans must cover specified preventive services, including certain women’s preventive...more

Omnibus 340B Guidance Raises New Issues for Covered Entities

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...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

When the Government Comes Knocking

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

OIG Approves Limited, Free Drug Program

On August 12, 2015, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 15-11, approving two pharmaceutical manufacturers’ free starter drug program. Citing the limited scope...more

Corridors September 2015 - News for North Carolina Hospitals

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

Washington Healthcare Update

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

Also In The News - Health Headlines - August 2015 #4

President Obama Signs Outpatient Status Notification Bill On August 6, 2015, President Obama signed the Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act. This legislation requires hospitals...more

The Scoop on MOOP: McGuireWoods Healthcare Reform Guide: Installment No. 53

This is the 53rd in a series of WorkCite articles concerning the Patient Protection and Affordable Care Act and its companion statute, the Health Care and Education Reconciliation Act of 2010 (referred to collectively as the...more

IREG Update - August 2015 #2

Hot Topic: New York Emergency Medical Services and Surprise Bills Law - Earlier this year, New York’s Emergency Medical Services and Surprise Bills Law went into effect (the full text of the bill is available on the...more

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

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