News & Analysis as of

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 -

This Year May be a Game Changer for 340B Drug Discount Program, Take Two

I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed...more

OIG Issues Letter Declining to Impose Administrative Sanctions for Provision of Certain Free Drugs

by Holland & Knight LLP on

On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more

Causes of Healthcare Data Breaches

by Bryan Cave on

Pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), covered entities (e.g. healthcare providers and health plans) must notify the Department of Health and Human Services (“HHS”) of breaches...more

Finance Committee Advances HHS Secretary Nominee Azar

by Reed Smith on

On January 17, 2018, the Senate Finance Committee voted to advance the nomination of Alex Azar to be Secretary of Health and Human Services (HHS) by a vote of 15-12. The nomination now moves to the full Senate....more

Court Upholds Procedural Validity of HHS's Outlier Reconciliation Instructions

by Baker Ober Health Law on

On December 26, 2017, the United States Court of Appeals for the District of Columbia Circuit upheld the procedural validity of 2010 manual instructions setting out the criteria by which Medicare outlier payments might be...more

Four-Term Governor Jerry Brown: One Last Budget

This week, California Governor Jerry Brown, beginning the final year of his unprecedented four terms as governor, unveiled his 16th and last state budget proposal, which projects a $6.1 billion surplus, mostly a result of...more

Window on Washington - Vol. 2, Issue 2

by Clark Hill PLC on

Shutdown Watch: 4 Days. The government will run out of money on Friday if it does not pass another short-term spending bill. Last week it looked like Congress was close to negotiating a short-term continuing resolution that...more

HHS OCR Announces a $2.3 Million HIPAA Settlement Bringing the Agency’s Settlement Total for 2017 to Over $19 Million

by Arnall Golden Gregory LLP on

On December 28th, the Department of Health and Human Services Office of Civil Rights (OCR) announced a $2.3 million settlement with 21st Century Oncology Inc. (21st Century) to settle potential violations of the HIPAA privacy...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Republicans will gather tonight for a GOP-only meeting to plot strategy on passing a stopgap budget bill, but a breakdown among key senators on separate immigration legislation has elevated the risk of a government...more

In a Class Action, a Federal Court Rejects HHS OCR Interpretation of ACA Section 1557 and Limits the Reach of Unintentional...

by Arnall Golden Gregory LLP on

In a class-action lawsuit, the Northern District of Illinois has deepened a pre-existing district-court split on a key legal question under Section 1557 of the ACA and, in doing so, explicitly rejected a pivotal HHS OCR...more

ACA Risk Corridors Update: Federal Circuit Holds Oral Argument in the Land of Lincoln and Moda Cases

by Faegre Baker Daniels on

In a crowded courtroom on January 10, the U.S. Court of Appeals for the Federal Circuit held oral argument on appeals of two Risk Corridors decisions from the Court of Federal Claims. The two cases, Land of Lincoln and Moda,...more

What are Your Thoughts on the Draft Trusted Exchange Framework?

by Farrell Fritz, P.C. on

On January 5, 2018, the United States Department of Health and Human Services released for public comment a draft Trusted Exchange Framework, which seeks to accomplish interoperability with respect to patients’ Electronic...more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On January 8, 2018, the Department of Veterans Affairs (VA) issued a rule entitled, Reimbursement for Emergency Treatment. The VA revised its regulations concerning payment or reimbursement for emergency treatment for...more

ICYMI: PrivSec’s Weekly News Picks

by Davis Wright Tremaine LLP on

Tech Republic reports that “the executive order may help bring internet to previously hard to reach areas, something several ISPs have been working towards.” “A more connected country”, author Olivia Krauth reports, “could...more

DOJ Releases its 2017 False Claims Act Recovery Statistics

On December 21, 2017, the United States Department of Justice (DOJ) released its annual False Claims Act (FCA) recovery statistics for fiscal year (FY) 2017. The press release measures the DOJ’s total haul at $3.7 billion....more

Manatt on Health: What’s Ahead in 2018

Congress returned from recess with a large agenda for the new year. The federal government is only funded through January 19 and the next funding bill is expected to carry with it longer-term extensions of the Children’s...more

OIG Reaffirms Permissibility of Certain Gainsharing Arrangements

The Department of Health and Human Services Office of the Inspector General (OIG) has issued an Advisory Opinion (Opinion) in connection with a hospital’s gainsharing arrangement (Arrangement) with a designated group of...more

Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

by McDermott Will & Emery on

Introduction - Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more

2017 Protest Roundup

In addition to our regular recap of key protest decisions by the Government Accountability Office (GAO) and Court of Federal Claims this month, we have compiled a year-end recap of key bid protest decisions from 2017. The...more

OIG Invites Anti-kickback Safe Harbor, Fraud Alert Recommendations

by Reed Smith on

The HHS Office of Inspector General (OIG) has published its annual solicitation of recommendations for new or revised anti-kickback statute safe harbors and new Special Fraud Alerts. The OIG states that in considering any...more

ERISA Newsletter - Fourth Quarter 2017

by Proskauer Rose LLP on

Editor's Overview - For over two decades, federal law has required covered health plans and insurers to ensure that certain mental health benefits are in parity with offered medical/surgical benefits. The meaning of...more

Pushing “PAUSE” on the 340B Program: The New Bi-Partisan Bill that Could Reshape the 340B Program

by McDermott Will & Emery on

In late December 2017, Republican Rep. Larry Bucshon (with bi-partisan support) introduced the “340B Protecting Access for the Underserved and Safety-net Entities Act” (340B PAUSE Act), legislation that would implement a...more

Capitol Hill Healthcare Update

by BakerHostetler on

With less than two weeks before another deadline to avert a government shutdown, Republican leaders on Capitol Hill say they’re cautiously optimistic about crafting a budget agreement that also would include several key...more

Window on Washington - Vol. 2, Issue 1

by Clark Hill PLC on

Another short-term continuing resolution is all but guaranteed as the current continuing resolution will expire later this month and budget talks last week did not result in a deal or hint at one in the near future. As the...more

Alston & Bird Healthcare Week in Review

by Alston & Bird on

On January 2, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule entitled, Confidentiality of Substance Use Disorder Patient Records. The final rule makes changes to the SAMHSA...more

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