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

DOJ Issues New, Practical Guidance on Effective Corporate Compliance Programs

On February 8th, the Department of Justice (DOJ) Criminal Division, Fraud Section issued new guidance on how it evaluates the effectiveness of a corporate compliance program when conducting an investigation of a corporation....more

District Court Allows Medicare Beneficiary Class Action to Proceed

On February 8, 2017, the United States District Court for the District of Connecticut declined to fully dismiss allegations filed by a class of Medicare patients against HHS in Alexander et al. v. Cochran (formerly Bagnall et...more

Medicare & Medicaid Remain Vulnerable to Fraud and Abuse, GAO Warns

The Government Accountability Office (GAO) is out with the latest installment of its “High-Risk Series,” which identifies federal programs “that are especially vulnerable to waste, fraud, abuse, and mismanagement, or that...more

$3.2M Fine for Failure to Protect Electronic Records

The Department of Health and Human Services Office of Civil Rights (“OCR”) fined a Texas hospital $3.2 million for its impermissible disclosure of unsecured electronic protected health information (ePHI) and non-compliance...more

SAMHSA Issues Final Rule Modernizing Confidentiality Requirements for Patients Receiving Substance Use Disorder Treatment

Last month, the U.S. Department of Health and Human Services (“HHS”) Substance Abuse and Mental Health Services Administration (“SAMHSA”) released a Final Rule updating the Confidentiality of Alcohol and Drug Abuse Patient...more

OIG Announces Drug Pricing and Reimbursement Web Portfolio

On February 17, 2017 the Office of the Inspector General (OIG) posted a Drug Pricing and Reimbursement Web portfolio on its website that, according to the OIG announcement, “pulls together the HHS OIG’s body of work since...more

HHS Report Acknowledges Complications of Fraud and Abuse Statutes on Value-Based Arrangements

HHS posted a report to Congress on its website in August 2016 that responds to the requirements in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to offer legislative and regulatory suggestions regarding the...more

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

Congress moves forward on key healthcare appointments; the Administration takes steps to shore up the Marketplaces; and Governors prepare to gather in Washington as new reports document the ACA's impacts on states....more

Lessons Gleaned From Recent HIPAA Settlements: An Ounce of Prevention is Worth a Pound of Cure: How Recent OCR Enforcement...

HIPAA enforcement has been on the rise during the last several years, and the dollar impact of those settlements has continued to grow significantly. The Department of Health and Human Services, Office of Civil Rights (OCR)...more

President Trump Props Up the ACA: A Summary of the New Administration's ACA Market Stabilization Regulation

On February 15, President Trump and new Department of Health and Human Services (HHS) Secretary Tom Price released their first proposed regulations addressing the Affordable Care Act (ACA). While remaining committed to...more

What’s Ahead for Value-Based Health Care?

Prior to the presidential election in November, experts believed that the trend toward value-based payment – the concept of rewarding providers based on the quality of care delivered, rather than the number of procedures...more

Price Confirmed as HHS Secretary; Hearing Scheduled on Verma Nomination

Early in the morning of February 10, 2017, the U.S. Senate confirmed Rep. Tom Price (R-GA) to be the Secretary of Health and Human Services. Senators voted along party lines, 52 to 47, to confirm Rep. Price, an orthopedic...more

Insider Trading Around Private Placements: Was Tom Price’s Investment Down Under Above Board?

On February 10, the Senate confirmed Representative Tom Price (R-GA) as Secretary of Health and Human Services, where he will oversee the U.S. Food and Drug Administration (FDA). His nomination has not been without...more

OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement

For several years now, the public outcry over the issue of drug pricing and reimbursement has increased in frequency and fervor. At least one government agency wants you to know that it has been listening and wants to help...more

$5.5 Million HIPAA Settlement Underscores Importance of Audit Controls

On February 16, 2017, the HHS Office for Civil Rights (OCR) disclosed a $5.5 million settlement with Memorial Healthcare Systems (MHS) for HIPAA violations affecting the protected health information (PHI) of 115,143...more

OIG Finalizes Expanded Exclusion Authorities under ACA (Updated)

On January 12, 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services issued the final rule implementing its statutory authority under the Affordable Care Act (ACA) to expand the exclusion...more

$5.5 Million HIPAA Settlement Matches Largest Payment To-Date

On February 16, 2017, the U.S. Department for Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced that Memorial Healthcare Systems of Florida (“MHS”) agreed to pay $5.5 million and enter into a...more

Confidentiality of Alcohol and Drug Abuse Patient Records - Final Rule Revising Regulations

The Department of Health and Human Services (HHS) has released a final rule to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations effective February 17, 2017. ...more

340B Drug Pricing Program: The Withdrawal of Mega Guidance and the Future of Patient Definition

In the wake of a recent directive issued by the Trump administration to halt pending regulations and guidance while the new leadership conducts its own review, the Department of Health and Human Services, on January 30, 2017,...more

Want to Know Why Memorial Healthcare Systems Is Paying HHS OCR $5.5 Million?

On February 16, 2017, HHS OCR announced that Memorial Healthcare Systems (MHS) had paid the U.S. Department of Health and Human Services (HHS) $5.5 million to settle potential violations of HIPAA’s Privacy and Security Rules...more

Major Effects of Revised Common Rule on Regulation of Clinical Research in New York

On January 19, 2017, the U.S. Department of Health and Human Services (HHS), together with 15 other federal Departments and Agencies, issued a final rule to revise and modernize the federal Policy for the Protection of Human...more

New HHS Secretary Delays Effective Date of Part 2 Final Rule

We previously reported that the 30 year old regulations (last updated in 1987) relating to the disclosure of substance abuse treatment information has been updated by SAMHSA to bring it into the modern world of electronic...more

42 C.F.R. Part 2 Final Rule Is Officially Delayed … Can Comments to HHS and OMB Fix It?

On January 18, 2017, the U.S. Department of Health and Human Services (HHS) published a final rule amending the Confidentiality of Substance Use Disorder Patient Records rule at 42 C.F.R. Part 2. Yesterday, HHS delayed the...more

HIPAA for HR - Some Good News for Employers

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that was enacted to ensure protection of individuals’ protected health information (PHI). The Standards for Privacy of Individually...more

Six Key Changes to the Common Rule

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

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