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

District Court Denies Stay in Litigation Over Medicare Appeals Backlog

On September 19, 2016, the U.S. District Court for the District of Columbia rejected a request by HHS to stay proceedings in litigation brought by the American Hospital Association and several providers seeking to compel the...more

Summer Fraud and Abuse Roundup

Now that the kids are back in school and summer vacations are in the rearview mirror, it’s time to catch up on recent fraud and abuse developments. The federal government was busy this summer negotiating a pair of settlements...more

HHS Proposes Changes to State Medicaid Fraud Control Unit Rules

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have proposed amendments to the regulations governing State Medicaid Fraud Control Units (MFCUs). The proposed rule would reflect...more

Taking Measure of HIPAA Enforcement

Last month, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced the largest settlement to date for alleged violations of the Health Insurance Portability and Accountability Act (HIPAA)....more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

Penalties For Health Care Law Violations Surge

The civil monetary penalties for violations of myriad health care laws continue to rise. In June, we discussed the enormous increase in penalties under the federal False Claims Act (“FCA”). Through an interim final rule, the...more

A Deeper Dive: Employers Receiving Federal Funding May Be Subject to ACA’s Nondiscrimination Rule and Need to Cover Transgender...

In recent months, we have written a fair amount about providing transgender benefits in light of the nondiscrimination provisions of the Affordable Care Act. Our blogs of March 30, 2016 and June 22, 2016 highlight the key...more

Capitol Hill Update

Bipartisan legislation introduced in the Senate last week would require pharmaceutical manufacturers to alert the U.S. Department of Health and Human Services (HHS) before increasing prices more than 10 percent, continuing...more

Also In The News - Health Headlines - September 2016 #2

340B Program Final “Mega Guidance” at OMB – On September 1, 2016, the White House Office of Management and Budget (OMB) received final omnibus guidance for review from HHS regarding the 340B Drug Pricing Program. ...more

Washington Healthcare Update

1. Congress - House of Representatives - House Energy and Commerce Committee Republican Leaders Send Letter to HHS OIG Concerning NIH Grant on Traumatic Brain Injury - On Sept. 15, Republican leaders of the...more

Law Revamping Medicare ID Cards to Be Revived

Lawmakers are again eyeing ways to modernize the Medicare system, including a revamping of the identification cards used by Medicare beneficiaries. On Wednesday, the House Ways and Means’ health subcommittee held a hearing on...more

The Risk Corridors End Game

Since the first cases were filed earlier this year, we have been following nationwide litigation seeking full risk corridors payments to qualified health plans (QHPs) providing coverage on the Affordable Care Act (ACA)...more

Nondiscrimination Final Rule under the ACA Imposes New Requirements on Hospice Agencies

On May 26, 2016, the United States Department of Health and Human Services (HHS), Office of Civil Rights (OCR), issued the “Nondiscrimination in Health Programs and Activities” final rule, implementing Section 1557 of the...more

Causes of Healthcare Data Breaches

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

Nondiscrimination Standards Under ACA Section 1557: Now Is the Time to Act

Health insurers and group health plan sponsors must closely review the final rule titled “Nondiscrimination in Health Programs and Activities” (“Final Rule”) implementing Section 1557 of the Affordable Care Act (“ACA”) that...more

Florida House Members Request Emergency Authorization to Combat Aedes aegypti Mosquitoes with Oxitec

On September 6, 2016, 61 members of the Florida House of Representatives issued a letter to the U.S. Department of Health and Human Services (HHS) and to the U.S. Food and Drug Administration (FDA) to urge them to: (1)...more

Federal Agencies Forced to Implement Huge Increases in Civil Monetary Penalties for Health Care Fraud

Thanks to section 701 of the Bipartisan Budget Act of 2015, Public Law 114–74, federal agencies have been forced to implement huge increases in penalties intended to deter health care fraud. The Federal Civil Penalties...more

Don’t Ignore Ransomware Vulnerabilities; You Could Be Violating FTC Act

Last week, the Federal Trade Commission convened a ransomware workshop to discuss the rising epidemic of attacks against U.S. businesses and individuals. In a ransomware attack, a malicious actor tricks a user into...more

Manatt on Health Reform: Weekly Highlights - September 2016 #2

CMS denies Ohio’s Medicaid 1115 waiver request citing the State’s premium proposal; HHS will use 2015 risk corridors collections for remaining 2014 payments; and Alabama closes its Medicaid budget shortfall....more

Health Care Employers Heads Up: What You Need to Know About Section 1557 of the Affordable Care Act

As the current presidential administration winds up its time in office, the administrative branch is hard at work completing its regulatory agenda. Part of this effort is implementing Section 1557 of the Affordable Care Act...more

Banner Health Suits Raise Significant Questions for Data Breach Class Actions

Banner Health recently announced that hackers may have gained “unauthorized access to patient information” and “payment card data” from approximately 3.7 million patients, health plan members, food and beverage customers, and...more

OCR Continues to Strengthen HIPAA Enforcement Efforts

The United States Department of Health and Human Services Office for Civil Rights ("OCR") sent a strong HIPAA enforcement message this summer, entering four resolution agreements, including the highest financial settlement to...more

Recent HHS Report Provides Insight into Government’s View of the Challenges of and Need for Expanded Telemedicine

The Department of Health and Human Services has issued, at Congress’s request, a report on the Department’s progress and efforts in the telemedicine arena, which has yet to be fully integrated within the government’s health...more

GAO, OIG Issue Reports on Medicare Part B Drug Payment Issues

The HHS Office of Inspector General (OIG) and the Government Accountability Office (GAO) recently issued several reports on various Medicare Part B drug reimbursement issues. In a report entitled “Medicare Part B: Data on...more

Changing Legal Landscape in Transgender Health Coverage

Gender identity and transgender rights have come to the forefront in the news over the past few years. While the case law is more settled with respect to transgender discrimination in the workplace, not much guidance is...more

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