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

Generic Drug Manufacturers to be Investigated by HHS for Recent Price Hikes

On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more

Washington Healthcare Update

This Week: Montana Legislature Reverses Course, Endorses Medicaid Expansion... Final 2016 Medicare Advantage and Part D Rate Announcement and Call Letter... Upcoming: Energy and Commerce Subcommittee Hearing on Post-Acute...more

CMS establishes Health Care Payment Learning and Action Network

Since the passage of the Affordable Care Act, we have been discussing the move from volume payment to value payment in healthcare. Now, you have an opportunity to have an impact on CMS’ alternative payment models....more

Healthcare Legal News Volume 5 Number 2

According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

Proposed HHS Rule Sets the Stage for Changes to the Meaningful Use Program

On March 30, the Department of Health and Human Services’ (HHS) Centers for Medicare & Medicaid Services (CMS) published its proposed rulemaking for Stage 3 of the Medicare and Medicaid Electronic Health Records (EHR)...more

Supreme Court Blocks Provider Challenges to Medicaid Program

On March 31, 2015, the Supreme Court issued the first of several expected decisions that will impact the healthcare industry this year, ruling that Medicaid providers have no constitutional or statutory right to challenge a...more

"Next Generation" ACO Model Announced by CMS

In a March 10, 2015 press release, CMS announced a new addition to its existing Accountable Care Model (ACO) portfolio: Next Generation ACOs. As stated by CMS in its press release, this new ACO model will allow for already...more

Manatt on Health Reform: Weekly Highlights - April 2015

Early data emerges on the impact of Medicaid expansion on states’ budgets and enrollees’ healthy behaviors. Read on for the latest in state and federal health reform updates and Manatt’s staffing announcement. ...more

Supreme Court Says Private Health Care Providers Cannot Sue to Force State of Idaho to Raise Its Medicaid Reimbursement Rates

In Armstrong v. Exceptional Child Center, Inc., Case No. 14-15, issued March 31, 2015, the United States Supreme Court ruled that a group of private health care providers could not sue officials in Idaho’s Department of...more

DOJ and HHS Annual Report Highlights $3.3 Billion in Settlements and Judgments in FY 2014

On March 19, 2015, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) issued their annual Health Care Fraud and Abuse Control (HCFAC) Program report highlighting that the HCFAC Program obtained...more

Washington Healthcare Update

This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

Pharmacies: Watch Out for Future HHS Crackdowns on Security Rule Violations

As we all know by now, HIPAA required the Secretary of the U.S. Department of Health and Human Services (HHS) to adopt regulations protecting the privacy of "protected health information" (PHI). HHS responded to that...more

Weekly Update Newsletter - April 2015

GOVERNMENT CONTRACTS - GSA and HHS Issue a Notice Regarding Conducting a National Dialogue To Reduce Reporting Compliance Costs for Federal Contractors and Grantees - The General Services Administration (GSA)...more

Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers

On March 19, 2015, the U.S. Department of Justice and the U.S. Department of Health and Human Services issued their joint annual report on health care fraud and abuse control. The annual report states that during fiscal year...more

Washington Update: Meaningful Use Stage 3 and 2015 Voluntary EHR Certification Criteria Proposed

On Monday, March 23, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) issued a notice of proposed rulemaking for Stage 3 Meaningful Use of Electronic Health...more

Health Alert (Australia) - March 30, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 25 March 2015 - Smythe v Burgman (No 2) [2015] NSWSC 150 - The New South Wales Supreme Court has held...more

Washington Healthcare Update

This Week: House Approves FY 2016 Budget Proposal... House Passes Permanent SGR Reform and Two-Year CHIP Reauthorization... Senate Passes FY 2016 Budget Plan... HHS Report: ACA Led to $7.4 Billion Decline in Uncompensated...more

Health Care Update - March 2015 #4

In This Issue: - Permanent Medicare Doc-Fix Entering Critical Week - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Congressional Initiatives - Other...more

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

HHS Releases Two Healthcare Information Technology Proposed Rules

On March 20, 2015, CMS and the HHS Office of the National Coordinator for Health Information Technology (ONC) released proposed rules regarding Stage 3 of the Medicare and Medicaid Electronic Health Records (EHRs) Incentive...more

HHS Releases List of 25 Unimplemented Recommendations to Save Money and Improve Quality in Medicare and Medicaid

On March 16, the Office of Inspector General of the U.S. Department of Health and Human Services released the Compendium of Unimplemented Recommendations, an 83-page document that identifies 25 priorities for saving money and...more

Sharing Clinical Trial Data: A New Era in Life Sciences Has Begun

The European Medicine Agency’s (EMA) Policy on Publication of Clinical Data for Medicinal Products for Human Use (“EMA Policy”)is now effective as of January 1, 2015. Across the Atlantic, the U.S. Institute of Medicine (IOM)...more

$12.6 Million Sandoz ASP Reporting Settlement Raises More Questions Than It Answers

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP). Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to...more

GAO Calls for Expanded HHS Efforts to Reduce Antipsychotic Drug Use in Community Settings

The Government Accountability Office (GAO) has issued a report examining the extent to which antipsychotic drugs are prescribed for older adults with dementia in nursing homes and other settings. ...more

OIG Posts FY 2014 State Medicaid Fraud Control Unit (MFCU) Data

The HHS Office of Inspector General (OIG) has released detailed statistical data on MFCU enforcement actions, recoveries, and expenditures for fiscal year 2014. ...more

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