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

Justice Department Announces Unprecedented National Health Care Fraud Takedown

In what is being billed as the largest coordinated Medicare fraud takedown in Justice Department history, Attorney General Loretta E. Lynch and Department of Health and Human Services (HHS) Secretary Sylvia Mathews Burwell...more

Health Update - June 2016

Real-Time Data Analytics in Government Investigations and Reducing Exposure - It is not every day that the words “innovative” and “nimble” are used when referring to an agency of the federal government bureaucracy. Yet,...more

Significant Hospital Related Mid-Year Updated OIG Review Activities

This is the second of three alerts discussing the mid-year update to the Fiscal Year 2016 Work Plan issued by the Office of Inspector General (OIG). In the first alert we discussed the top management performance challenges...more

Transitioning to Coverage: Three Things to Know About the New Transgender Healthcare Regulations

On May 18, 2016, the Department of Health and Human Services (“HHS”) issued final regulations implementing the nondiscrimination provisions of the Affordable Care Act. As we discussed in our March 30, 2016 blog, the rule...more

Managing the Transition to Transformation: Is Your Organization Ready for the Shift to Alternative and Quality-Based Payment...

For many decades, at least since the passage of the Health Maintenance Organization Act of 1973, there have been reform efforts focused on moving the United States health care system away from fee-for-service (FFS)...more

HHS Issues Final Rule on ACA Nondiscrimination in Health Programs and Activities

On May 18, 2016, the Department of Health and Human Services (“HHS”) issued final regulations interpreting the nondiscrimination provisions of Section 1557 of the Affordable Care Act (“ACA”). The rule mainly impacts insurers...more

Why the FDA Needs to Change Its Food Recall Policies

Add this to FDA’s growing list of things to do: improve the food recall initiation process. According to a memorandum published on June 8, 2016, the Office of Inspector General (OIG) of the Department of Health and Human...more

HHS Final Rule Finds Categorical Exclusions for Health Services Related to Gender Transition Are Generally Unlawful

The U.S. Department of Health and Human Services (HHS) recently published its Final Rule implementing Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the basis of, among other grounds, sex in...more

GAO Highlights Significant Backlog in Medicare Appeals, Routine ALJ Failure to Meet Statutory Deadlines

The Medicare appeals process has not been able to keep up with an explosion in the number of volume, particularly at the administrative law judge (ALJ) level (Level 3), resulting in significant backlogs and widespread failure...more

All About APMs: What Will It Take for Physicians to Earn the APM Bonus Under MACRA?

On May 9, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule addressing the implementation of physician payment reforms included in the Medicare Access and CHIP Reauthorization Act of 2015...more

OIG Releases Mid-Year Update to its FY 2016 Work Plan

The HHS OIG has updated its FY 2016 Work Plan to reflect new and/or completed items since initial release of the FY 2016 Work Plan in November 2015. For instance, the mid-year update indicates that the OIG plans to conduct...more

OCR Releases Video Guidance on Provision of Medical Records

The summer movie season is now officially in full swing, with the release of three informational videos regarding HIPAA and the right of individuals to access their medical records, published by the Office of Civil Rights of...more

OIG Mid-Year Updated Provides Insight To Its Concerns

The Office of Inspector General (OIG) recently released its mid-year update of its Fiscal Year Work Plan for 2016. The Work Plan summarizes new and ongoing reviews and activities that the OIG plans to pursue. Not...more

Healthcare Lessons Learned From Reality TV

On March 31, 2016, a New York court determined that a lawsuit may proceed against a physician and hospital for breach of physician-patient confidentiality arising from a documentary series about medical trauma, NY Med. The...more

Employment Law - June 2016 #2

California Considers Extending Fair Pay Act to Race, Ethnicity - Why it matters - Reflecting the nationwide trend of pay equity, a new bill under consideration by California legislators would extend the state's Fair...more

GAO Issues Recommendations To Improve Medicare Appeals Backlog

On June 9, 2016, the Government Accountability Office (GAO) publicly released a report published May 10, 2016, regarding the continuing challenges surrounding the backlog of the administrative appeals process for Medicare...more

Nondiscrimination Protection Under the Affordable Care Act

On May 16, 2016, the Department of Health & Human Services (“HHS”) Office of Civil Rights (“OCR”) issued final rules implementing Section 1557 of the Patient Protection and Affordable Care Act (the “ACA”). The final rules...more

HHS Issues HIPAA Guidance for Mobile Health Apps

The U.S. Department of Health and Human Services (HHS) recently issued guidance to help mobile application developers analyze whether the Health Insurance Portability and Accountability Act of 1996 (HIPAA) may apply to them....more

The Future of Provider-Based Status Post-BBA 2015

This month, hospitals impacted by Section 603 of the Bipartisan Budget Act of 2015 (BBA) may finally get a glimpse of what the future holds for the off-campus departments they operated or were developing when the BBA was...more

HHS guidance seeks to clarify scope of PSQIA

On May 24, 2016, the Department of Health & Human Services (HHS) issued guidance (Guidance) to health care providers and patient safety organizations (PSOs) in an attempt to clarify the definition of patient safety work...more

Hospital and Fixed Indemnity and Disease-Specific Policies in the Cross Hairs: Tri-Agency Proposed Rule Portends Some Disruption

On June 10, the Departments of Treasury, Labor, and Health and Human Services (The “Departments”) issued a set of proposed regulations dealing with expatriate health plans, excepted benefits, lifetime and annual limits, and...more

Health Law Insights Newsletter - Issue 10 - June 2016

McCarter & English, LLP’s Health Care Group presents Issue 10 of the Health Law Insights, which discusses the latest legal issues in the health care industry. NATIONAL - Drug Diversion Case Raises Red Flags for...more

Summary: Final Rule on Nondiscrimination in Health Programs and Activities

Section 1557 of the Affordable Care Act (“ACA”) establishes a broad prohibition on discrimination on the basis of race, color, national origin, sex, age or disability in health programs and activities. After almost 3 years of...more

Free Transportation Gets Another Nod from OIG

On March 1, 2016, the Department of Health and Human Services Office of Inspector General once again issued a favorable advisory opinion for the provision of free transportation by a healthcare facility. In this instance, an...more

HHS Agenda Signals FDA’s Intent to Issue Proposed DSCSA Rules in December 2016

FDA intends to issue long-awaited proposed regulations governing the licensing of prescription drug wholesale distributors and third-party logistics providers (“3PLs”) this December, according to the updated 2016 HHS...more

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