Dept. of Health and Human Services Medicaid

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

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

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

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

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

Shifting Hospice Reimbursement – Moving in the Direction of Aligning Payment with Resource Concentration

The United States Department of Health and Human Services (HHS) Centers for Medicare & Medicaid Services (CMS) published its update to the home health prospective payment system (HHPPS) for fiscal year (FY) 2016 in the August...more

Manatt on Health Reform: Weekly Highlights - August 2015 #3

Ohio’s Medicaid expenditures came in $2 billion below estimates despite enrollment growth after Medicaid expansion; California extends full Medicaid benefits to more pregnant women; and nearly one million have enrolled in...more

The Government’s Generic Price-Fixing Investigation Targets Allergan’s Actavis Unit

This is our fourth post on the DOJ’s expanding investigation into possible price fixing by generic drug manufacturers. (Click here, here, and here to read our prior posts.) Since our last update, the DOJ has subpoenaed...more

Manatt on Health Reform: Weekly Highlights - August 2015 #2

Reductions in uninsured rates are greatest in states with Medicaid expansions and State-based or State Partnership Marketplaces; Kentucky finds increased use of preventive healthcare following Medicaid expansion; and,...more

Health Care Update - August 2015 #2

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more

Manatt on Health Reform: Weekly Highlights - August 2015

Increased plan choice on HealthCare.gov is linked to lower premium growth; Arizona seeks changes to Medicaid expansion; and California and New York release detailed Marketplace and Medicaid enrollment reports....more

OIG Issues Favorable Advisory Opinion of Hospital Leasing Arrangement

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services published Advisory Opinion 15-10 (Opinion). The Opinion addressed a hospital system’s proposal to lease non-clinician employees...more

After Almost 25 Years--New Long-Term Care Regs: An Impressive and Costly Undertaking

On July 16, 2015, CMS released its long-awaited proposed changes for Medicare/Medicaid participation by long-term care (“LTC”) facilities. The new regulations represent the first comprehensive change to the requirements since...more

Impending Deadline: CMS Issues Proposed Rule Reform for Long Term Care Facilities – Part 3 of 4

On July 16, 2015, the Federal Register published Centers for Medicare and Medicaid Services’ (CMS) proposed rule to reform the requirements for Long Term Care Facilities participating in Medicare and Medicaid. CMS will be...more

Criminal Prosecutions of Health Care Fraud: The Stakes Continue to Rise for Individual Providers

On June 18, 2015, the U.S. Department of Justice (DOJ), in collaboration with the U.S. Department of Health and Human Services (HHS), announced criminal charges against 243 individuals located in 14 states for various health...more

CMS Proposes Sweeping Changes for Nursing Home Oversight

On July 16, 2015, the Center for Medicare and Medicaid Services (“CMS”) published a Proposed Rule with new standards that will have a sweeping effect on the long-term care industry. This new Rule is the first comprehensive...more

Health Care Update - July 2015 #3

ACA Repeal Votes Continue: As part of a rare Senate Sunday session to consider a bill to replenish the highway trust fund for six years, Majority Leader Mitch McConnell (R-KY) brought up an amendment to repeal the ACA—in...more

Washington Healthcare Update

This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more

Medicaid Managed Care Update: Accelerating State-Led Payment and Delivery System Reform

In the wake of the implementation of the Affordable Care Act, the recent Medicare Managed Care Proposed Rule (the Proposed Rule) exemplifies the accelerated push by the Department of Health and Human Services and Centers for...more

Manatt on Health Reform: Weekly Highlights - July 2015 #3

In quick succession, governors in Alaska and Utah announce Medicaid expansions this week; Iowa is transitioning its expansion away from the Marketplace to Medicaid managed care, for now; and, HHS extends its exception to...more

OIG Report Raises Serious Medicare Part D Fraud, Waste and Abuse Concerns

Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more

CMS Issues Proposed Rule Reform for Long Term Care Facilities - Part 1 of 4

On July 13, 2015, CMS issued a proposed rule to reform the requirements for long term care facilities participating in Medicare and Medicaid. The 400-page proposed rule recommends the biggest overhaul to nursing home...more

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