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

Hobby Lobby Redux

The regulations set forth two possible approaches to defining a “qualifying closely held for-profit entity” In Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014) the Supreme Court held that the requirement to...more

Judge Dismisses FDA Spying Case But Not Because It’s Innocent

Earlier this week a federal judge dismissed a lawsuit by six former and current FDA scientists who allege that the FDA retaliated and spied on them for blowing the whistle on FDA approval of medical devices that put cancer...more

Identify Yourself! Deadline for Health Plan Identifiers is Fast Approaching

One of the lesser-known health plan requirements adopted by the Patient Protection and Affordable Care Act (ACA) has an initial deadline that is fast approaching, and most employers will need to take action to ensure that...more

Health Reform + Related Health Policy News - September 2014, Issue 1

In This Issue: - Top News ..The Congressional Agenda is Light as the Focus Shifts to the Midyear Elections ..Physician Supervision Requirement for Small and Rural Hospitals ..CMS Offers Hospitals...more

Department of Justice Files First False Claims Act Lawsuit Against Physician-Owned Distributorship

On Sept. 8, 2014, the United States Department of Justice (DOJ) filed a 98-page civil complaint alleging that investment returns, paid to a Michigan spinal surgeon and other physicians by a spinal implant company partially...more

Recent Trends in HIPAA Liability

Since the passage of the 2013 HIPAA Omnibus Rule, there has been a substantial increase in HIPAA enforcement actions brought by the Department of Health and Human Services, including an increase in so-called “high-impact...more

Africa Update - September 2014 #4

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from...more

Health Headlines: Also in the News - September 2014 #3

Congressman Sends Letter to Secretary of HHS Urging Her to Retract CMS’s Global Settlement Offer – On September 15, 2014, Congressman Kevin Brady (R-Tex), Chairman of the House Ways and Means Health Subcommittee, sent a...more

OIG Reports Medicare Part B Supplying and Dispensing Fees Significantly Higher Than Those Under Part D and Medicaid

According to a recently released report from the HHS OIG, pharmacies are reimbursed significantly more for dispensing drugs under Medicare Part B than they would be for dispensing the same drugs under Medicare Part D and...more

House Passes Bill Requiring Post-Acute Providers to Collect Patient Assessment Data

The House recently passed its version of The Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 (H.R. 4994/S. 2553), which would require various post-acute providers, including inpatient rehabilitation...more

Lawmakers Call to Clarify HHS’ Mobile Medical App Regulation

The mobile medical application marketplace has developed into a $68 billion industry; however, the U.S. Department of Health and Human Services (HHS) has not yet updated guidance regarding the Health Insurance Portability and...more

Business Associate Agreement September 22 Deadline; Same Sex Marriage Guidance Released

There are two important updates with respect to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). First, on September 17, 2014, the U.S. Department of Health and Human Services (HHS) issued guidance to...more

OIG Releases Special Advisory Bulletin and Report on Copayment Coupons

Last week, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a Special Advisory Bulletin titled, Pharmaceutical Manufacturer Copayment Coupons (Bulletin), and a report titled,...more

Mishandling Medical Records Turns Into an $800,000 HIPAA-Compliance Mistake

A non-profit healthcare company agreed to pay $800,000 as part of a settlement with the U.S. Department of Health and Human Services (HHS) for allegedly mishandling 71 boxes of medical records in violation of the privacy rule...more

Health Law Alert: CMS Modifications to Meaningful Use Rule Gives Providers a Welcome Reprieve

On September 4, the Centers for Medicare & Medicaid Services (CMS) published a Final Rule that made several helpful changes to the meaningful use requirements for the Electronic Health Record (EHR) Incentive Program. Among...more

WEBINAR: Breach, Enforcement and Beyond: HIPAA Breach Notification Analysis and OCR Enforcement Activities

The Office for Civil Rights of the US Department of Health and Human Services revised the breach notification regulations last year in order to make the analysis of whether a breach occurred more objective. In addition, OCR...more

Health Care Reform Implementation Update September 2014

Congress is back in session, and work on a Continuing Resolution is underway. The Affordable Care Act (ACA) is back center stage with House Republicans attaching a medical device tax repeal provision to a jobs package set for...more

HHS Asserts the Everybody-Does-It Defense

If that sounds familiar, your child may have a future as a lawyer for Health & Human Services. Because that’s one of the primary arguments asserted by HHS last Friday in its motion to dismiss the lawsuit by the American...more

A (Second) Lawsuit Seeks to Compel Statutory Timeframe for Administrative Law Judge Review of Medicare Claims Appeals

On August 26th, the Center for Medicare Advocacy filed a nationwide class action lawsuit against the Secretary of Health and Human Services. The complaint alleges that, as implemented, the Medicare administrative review...more

Implications on Pharmacies of Recent OIG Advisory Opinion on Per-Fill Fees

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy (Requestor) to pay local pharmacies a per-fill fee...more

Health Care Update - September 2014

In This Issue: - HealthCare.gov Hacking Breach - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other Health...more

HIPAA Business Associate Agreements – Reminder of September 22, 2014 Deadline

On January 17, 2013, the U.S. Department of Health and Human Services (HHS) issued a final rule under HIPAA making substantial changes to the rules for vendors that provide services to HIPAA-covered plans, such as third-party...more

Court Report - September 2014

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. UCB Inc. et al. v. Watson Laboratories Inc. (NV) et al. 1:14-cv-01083; filed August 21, 2014 in the District Court of...more

Health Care Reform Implementation Update

As summer rolls to a close, the agencies continue to make announcements and roll out additional regulations. The Department of Health and Human Services (HHS) introduced the new CEO of Healthcare.gov, awarded grants to 147...more

Telehealth and Health IT Policy: Considerations for Stakeholders

In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more

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