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 -

HHS Subjects Human Research to an Updated Common Rule

by Alston & Bird on

The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to...more

Health Care Reform Weekly Roundup – Issue 5

The Senate’s health care reform bill was released today, and we will report on that separately. In the meantime, below are key health care reform developments from the week of June 12th....more

Healthcare Data Breach Enforcements and Fines

by Bryan Cave on

The Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) is responsible for enforcing the Privacy and Security Rules of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)....more

Manatt on Health Reform: Weekly Highlights - June 2017 #3

Senate health reform bill to be made public Thursday; CMS Actuary releases its AHCA coverage and cost projections; and new analysis finds Marketplace rate increases are being driven by the Trump Administration’s lack of...more

Rallying Cry: Health Care Cybersecurity a Key Public Health Concern

by Sedgwick LLP on

On June 2, 2017, the Health Care Industry Cybersecurity Task Force published its Report on Improving Cybersecurity in the Health Care Industry. The lengthy and comprehensive Report serves as a wake-up call to the medical...more

AGG Food and Drug Newsletter - June 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

My Entity Just Experienced a Cyber-Attack! What Do We Do Now?

by Balch & Bingham LLP on

On June 9, 2017, the U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) released a cyber-attack “Quick Response” checklist (the Checklist) for the benefit of HIPAA covered entities and business...more

"Meaningfully Useful" Risk Mitigation Strategies for Providers Following the eClinicalWorks Settlement

by Jones Day on

The Health Information Technology for Economic and Clinical Health Act ("HITECH Act") established financial incentives under Medicare and Medicaid for eligible health care providers that adopt, implement, and demonstrate use...more

New HHS Cybersecurity Preparedness Checklist

by Carlton Fields on

The Department of Health and Human Services’ Office of Civil Rights (OCR) recently published a checklist to guide HIPAA-covered entities and business associates through an appropriate response to a ransomware or cybersecurity...more

First Look at OIG’s FY 2017 Fraud Recoveries/Enforcement Activities

by Reed Smith on

The HHS Office of Inspector General (OIG) expects its investigative recoveries during the first half of fiscal year (FY) 2017 to top $2.04 billion – which is down from $2.77 billion for the first half of FY 2016. During this...more

Ch-Ch-Ch-Ch-Changes: Reporting Requirements for Updating Your CMS Provider Enrollment

by BakerHostetler on

With the possibility of significant penalties for improperly reported transactions, it is important to understand how certain changes necessitate specific reporting. Is your organization considering a stock transfer, a...more

HHS Report Urges Health Care Industry to Address Cybersecurity Risks

by Saul Ewing LLP on

In early June 2017, the U.S. Department of Health and Human Services (HHS) Health Care Industry Cybersecurity (HCIC) Task Force released a “Report on Improving Cybersecurity in the Health Care Industry” (the Report). The...more

Congressional Hearings, Markups Focus on Chronic Care, Drug Pricing, HHS Budget, Other Health Programs

by Reed Smith on

House and Senate committees have held a number of hearings recently to focus on health policy topics, including the following: - A Senate Health, Education, Labor & Pensions Committee hearing on “The Cost of Prescription...more

Privacy Tip #92 – Finally, HHS is Removing SSNs From Medicare Cards

For those of you who know me, you know that I have been very frustrated with the federal and state governments for continuing to use Social Security numbers for eligibility, enrollment and participating in Medicare and...more

NQF Telehealth Draft Report Provides Opportunity For Stakeholders

by Cozen O'Connor on

The National Quality Forum (“NQF”) has published a draft report (“Report”) recommending various methods to measure the use of telehealth. By way of quick background, NQF is a non-profit, nonpartisan organization that seeks...more

HHS Cybersecurity Guidance - You Still Have Work to Do

by Clark Hill PLC on

The U.S. Department of Health and Human Services Office for Civil Rights ("HHS") recently issued a quick response checklist to outline steps a HIPAA covered entity or business associate should take in response to a...more

$387,200 Fine from HHS OCR for the Improper Disclosure of PHI to an Employer and a Volunteer Organization

by Arnall Golden Gregory LLP on

On May 23, 2017, the Department of Health and Human Services Office of Civil Rights (HHS OCR) announced a settlement with St. Luke’s-Roosevelt Hospital Center, part of the Mount Sinai Health System, to resolve allegations...more

HHS Further Delays Effective Dates of Final Rules for 340B Drug Pricing Program and Cardiac, Orthopedic Bundled Payment Models

by King & Spalding on

On May 19, 2017, HHS further delayed the effective dates concerning two final rules issued during the Obama administration. First, HHS delayed until October 1, 2017 the effective date of a January 5, 2017 final rule for the...more

Manatt on Health Reform: Weekly Highlights - June 2017 #2

CMS seeks input on potential market stabilization rulemaking; Iowa proposes a single standardized Marketplace plan and reinsurance program; and Centene will expand its Marketplace offerings for 2018, including adding new...more

OCR Publishes Checklist and Infographic for Cyber Attack Response

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities,...more

Health Care Reform Weekly Roundup – Issue 4

After a brief recess, Congress is back in session and health care reform negotiations continue. Below is a summary of a few, relatively minor, developments that took place during recess and the week of June 5th....more

OIG Issues FY 2016 Annual Report of the Medicaid Fraud Control Units

by Arnall Golden Gregory LLP on

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued the Medicaid Fraud Control Units Fiscal Year 2016 Annual Report in May 2017. The Annual Report is based on analysis of statistical...more

OIG Faults CMS for its Medicare and Medicaid Improper Payment Rates

by King & Spalding on

Under the Improper Payments Information Act of 2002, as amended, the Department of Health and Human Services (HHS) is required to annually report on improper payments and meet certain improvement metrics. In a report...more

EHR Vendors Beware: eClinicalWorks Settles with DOJ for $155 Million

by Dorsey & Whitney LLP on

The Department of Justice (“DOJ”) announced on May 31, 2017, a $155 million settlement of its lawsuit alleging False Claims Act (“FCA”) and Anti-Kickback Statute (“AKS”) violations committed by eClinicalWorks (“eCW”), one of...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republicans continue intra-party discussions on changes to House-passed legislation replacing the Affordable Care Act (ACA), but the lack of consensus is threatening GOP leaders’ pledge to have a bill ready for a vote...more

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