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

Hey Dentists: No Business Associate Agreement, No Problem

According to the U.S. Health and Human Services Office for Civil Rights (OCR), dental practices are not required to have a business associate agreement with their dental laboratory before sharing protected health...more

Third-Party Payment of Premiums: Controversy and HHS Guidance

Since the passage of the Affordable Care Act (ACA), the payment of healthcare premiums by third parties has been the subject of controversy. As Congress develops its plan to repeal and replace the ACA, it is uncertain how...more

Health Update - March 2017

The Future of Essential Health Benefits - Editor's Note: The Essential Health Benefits (EHB) rule may be among the many parts of the Affordable Care Act (ACA) that are on the chopping block as the Trump Administration and...more

Updates to the Common Rule for the Protection of Human Subjects Research

On Sept. 8, 2015, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM) to seek input on changes to the Federal Policy for the Protection of Human Subjects, otherwise known as...more

Wyden’s C-THRU Act – Publicizing PBM Rebate Data

Last week, Senate Finance Committee Ranking Member Ron Wyden (D- Ore.) introduced the “Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017.” As its name suggests, it seeks to require parties (e.g., PBMs)...more

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

House Republicans append a Manager's Amendment to the AHCA; HHS tells states they will have increased flexibility on Medicaid; and Florida previews its 1115 waiver amendment requests....more

OIG Issues Favorable Advisory Opinion Relating to Free Hotel Lodging and Cafeteria Meals for Qualifying Patients

On March 3, 2017, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 17-01. The Opinion relates to a request by an academic medical center (the “Requestor”) consisting...more

Price, Verma Taking a Fresh Look at Obama Administration’s EPM/CJR Final Rule; Changes Pushed Back to at Least October 1, 2017

HHS Secretary Thomas Price and CMS Administrator Seema Verma have signaled that the Trump Administration is eyeing changes to one of the last major Medicare policies issued by the Obama Administration. Specifically, CMS is...more

Excluded Party Cases Dominate OIG Published Self Disclosure Settlements

In 2013, the HHS Office of Inspector General issued revised protocols outlining the process through which health care providers are able to self-disclose and resolve potential liability under the OIG’s civil monetary penalty...more

President’s Proposed Budget Increases Healthcare Fraud Enforcement Funding

Much of the discussion surrounding President Trump’s 2018 budget blueprint has focused on cuts, but one proposed budget increase shows the new administration is likely to continue focusing on healthcare fraud enforcement. ...more

Drug and Device Makers Suggest Anti-Kickback Safe Harbor Clarifications to Encourage Value-Based Health Care Arrangements

In response to the annual solicitation by the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) for developing new, and modifying existing, safe harbors to the anti-kickback...more

HHS States that Agency Will Not Be Able to Meet Deadline to Clear Medicare Appeals Backlog

In a status report filed on March 6, 2017, HHS revised projections regarding the Medicare appeals backlog, which make it unable to meet a court-imposed deadline to eliminate the backlog by 2020. The status report was filed in...more

HHS Secretary Backs Medicare Balance Billing

Generally speaking, patients really dislike balance billing. Sometimes called “surprise billing,” “balance billing” refers to billing a patient for the difference between the health care provider’s charge and the amount a...more

Trump Administration Proposes 17.9% Cut to HHS Programs, Doubling of FDA User Fees

The Trump Administration is calling for deep cuts to Department of Health and Human Services (HHS) funding for fiscal year (FY) 2018 along with a $1 billion hike in Food and Drug Administration (FDA) user fees in its “budget...more

DWT Releases Latest Health Care Breach Charts

Following the HITECH Act, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) issued regulations requiring HIPAA covered entities to provide certain notifications for breaches of unsecured...more

President’s Budget Blueprint Increases Funds For Health Care Fraud Enforcement

The President has released a “budget blueprint” for fiscal year 2018. Although there are many aspects of the budget blueprint to digest, several budget items signal that government health care fraud enforcement remains a...more

Senate Confirms Verma as CMS Administrator; Trump Nominates Gottlieb for FDA, Hargan as Deputy HHS Secretary

The Senate has approved the nomination of Seema Verma to be CMS Administrator on a vote of 55 to 43. In other nomination news, President Trump has nominated Scott Gottlieb to be Commissioner of Food and Drugs. Dr. Gottlieb is...more

Trump Administration Signals More Administrative Flexibility for State Medicaid Programs, with Emphasis on “Most Vulnerable...

In her first act as CMS Administrator, Seema Verma joined HHS Secretary Tom Price in writing to the nation’s Governors to urge collaboration on improving the Medicaid program, with an emphasis on services for “truly...more

"Trends in Corporate Integrity Agreements Reflect New HHS OIG Guidance on Use of Exclusion Authority"

2016 was a year of change for the Department of Health and Human Service's Office of Inspector General's (OIG) approach to corporate integrity agreements (CIA). The OIG began to use its new model CIA format and applied its...more

New Exclusion Rule on the Horizon

On January 12, 2017, the Department of Health and Human Services Office of Inspector General (“OIG”) published a final rule which provides guidance on its new and expanded bases for permissive exclusion from federal health...more

Caution About Fake Phone Calls from Health Care Agencies

Individuals should be cautious about sharing personally identifiable information when contacted via phone, including by health care agencies. The Centers for Medicare & Medicaid released an alert earlier this week warning of...more

Regulatory “Freeze” Thaws for HHS: Medicare FY 2018 IPPS/LTCH Rulemaking Process Gets Underway

The Centers for Medicare & Medicaid Services (CMS) is moving ahead on its annual Medicare hospital payment update rule – and it actually is ahead of last year’s pace. Specifically, on March 8, 2017 CMS sent to Office of...more

Trump Executive Orders Create Uncertainty for Health Care & Pharmaceutical Industries

As we’ve previously discussed on Health Law and Policy Matters, agencies within the Department of Health and Human Services (DHHS) pushed through several final rules towards the end of the Obama Administration. However, since...more

New OIG Exclusion Authority Rule Set To Go Into Effect on March 21, 2017

On January 12, 2017, just a week prior to President Trump’s Inauguration, the Department of Health and Human Service (HHS) Office of Inspector General (OIG) published a final Rule (Rule) regarding one of its most important...more

OIG Warns Public: Do Not Fall for “OIG Hotline” Scammers

The HHS Office of Inspector General (OIG) is warning the public that scammers are spoofing the OIG’s hotline telephone number to obtain personal information from individuals that then can be used to steal money from the...more

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