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 -
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News from the Health Law Gurus™

Patient Medical Records Stolen from New Jersey Storage Facility – Tribeca Medical Center is notifying patients that their protected health information may be compromised. According to a privacy notice posted on Tribeca...more

HHS Issues Notice of Proposed Rulemaking for Clinical Trials Registration and Results Submission to ClinicalTrials.gov

On November 19, 2014, the Department of Health and Human Services (HHS) published, for a 90-day public comment period, a Notice of Proposed Rulemaking (NPRM) for Clinical Trials Registration and Results Submission. The...more

CMS Releases Final Rule That Increases Difficulty of Medicare Enrollment

In early December, CMS released a final rule that implements certain provider (i.e., Hospitals, SNFs, physicians, etc.) and supplier (i.e., DME companies, etc.) enrollment requirements (“Rule”). The goal of CMS’...more

OIG Releases Proposed Gainsharing Regulation

In early October, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released a proposed rule that included, among other provisions, a proposed gainsharing regulation (“Proposed Rule”),...more

With a New Year Rolls in a New OIG Work Plan

Recently, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released its Work Plan for Fiscal Year 2015 (“Work Plan”). The OIG protects the integrity of HHS programs by identifying...more

Health Care Reform Implementation Update

We are now more than two weeks into the Affordable Care Act (ACA’s) second open enrollment period, and 765,000 individuals have obtained coverage through HealthCare.gov. On Capitol Hill, House lawmakers filed a lawsuit...more

HHS to Audit Hospital Reporting of GPO Payments: GAO Report Suggests Further Scrutiny of GPO Shareback with Hospitals

On November 24, 2014, the Government Accountability Office (“GAO”) published a report examining the contracting practices and funding structures of health care group purchasing organizations (“GPOs”) and their potential...more

Grand Theft PHI – Are Vendors Putting You at Risk for a HIPAA Breach?

Your vendor’s employee goes home after a long day of collecting wellness questionnaires and biometric screening results only to wake up the next day to discover that her car has been stolen from her driveway. As you can...more

HHS Broadens Federal Controls Over Private Health Insurance Benefits and Operations

On November 21, 2014, the Obama administration released two proposed rules affecting health insurance issuers’ offering of private health insurance products both inside and outside of the public insurance exchanges...more

Monthly Benefits Update - November 2014

U.S. Supreme Court Grants Review of ACA Case Involving Premium Subsidies Offered Through Federally Facilitated Exchanges - The Supreme Court granted review in King v. Burwell, a Fourth Circuit case that upheld an IRS...more

Texas Appeals Court Invalidates Certain Medicaid Payment Hold Rules

Last week, a Texas appeals court invalidated three rules that permitted the Texas Health and Human Services Commission (HHSC) and the Texas OIG to impose a pre-notice payment hold against a Medicaid provider in certain...more

GPO Fees Under Scrutiny by the GAO

Last week, the Government Accountability Office (GAO) released a report examining group purchasing organization (GPO) practices. The GAO questioned whether the current structure of GPO funding through administrative fees is...more

FDA Regulatory and Compliance Monthly Recap – November 2014

In an unusual move, the FDA takes issue with the accuracy of Sciecure’s studies in a warning letter over sales promotion material for the company’s sleeping pill - In addition to criticizing the pharmaceutical company...more

OIG’s New Work Plan Focuses on the Security of Health Information

On October 31, 2014, The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Work Plan for fiscal year (FY) 2015. The Work Plan summarizes “new and ongoing reviews of activities...more

Manatt on Health Reform: Weekly Highlights: December 2014

This week, a federal Issuer Bulletin describes how issuers in the Federally Facilitated Marketplace will identify their existing enrollees who are switching plans for 2015 coverage. The Exchange Board in New Mexico proposes a...more

Health Care Update - December 2014

In This Issue: - FDA Releases Menu Labeling Rule - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Upcoming Congressional Hearings - Excerpt from FDA...more

Ebola Outbreak Prompts HHS Bulletin on Application of HIPAA During Emergencies

The Health Insurance Portability and Accountability Act (HIPAA) was enacted by Congress and signed by President Bill Clinton in 1996. According to the U.S. Department of Health and Human Services (HHS), the HIPAA Privacy Rule...more

340B State of Affairs – Study Reveals Benefits to Vulnerable, Chronically Ill Patients

The 340B provider community received welcome news from a recent study published by Health Affairs, which published a long-awaited report analyzing 12 months of outpatient prescription data to identify trends in 340B contract...more

Alert: Closing Affordable Care Act Loopholes

The U.S. Departments of Labor, the Internal Revenue Service and the Department of Health and Human Services recently issued guidance clearly stating that employers may not, without incurring penalties, reimburse employees who...more

OIG Identifies Top 10 Management Challenges for HHS in Fiscal Year 2014

On November 18, 2014, the HHS OIG released its annual list of the top 10 management and performance challenges faced by HHS and the OIG during the current fiscal year, and the new and emerging issues that the OIG anticipates...more

GAO Takes Aim at GPOs

The GAO had drawn a bead on GPOs. In a report issued yesterday the Government Accountability Office expressed concern over the effect of GPOs (group purchasing organizations) on Medicare rates. The report recommended that...more

Caught Between Laws: Challenges for Health Care Providers in Using Criminal History Information in Employment Decisions

In an effort to increase protection for vulnerable patient populations, the Affordable Care Act (ACA) creates incentives for states to strengthen the employment background check programs available to long-term care providers....more

Preparing for HIPAA Compliance Audits

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), the office responsible for administering and enforcing the Health Insurance Portability and Accountability Act of 1996 (HIPAA), will...more

HIPAA Privacy in Emergency Situations

In light of the Ebola outbreak and other events, the U.S. Department of Health and Human Services, Office for Civil Rights, released a bulletin to ensure HIPAA covered entities are aware of the ways in which patient...more

No Sanctions for Basic Life Support Service Provider

The Office of Inspector General (OIG) recently issued Advisory Opinion 14-09 [PDF] and concluded that a town that uses tax revenues to cover out-of-pocket expenses owed for basic life support (BLS) emergency ambulance...more

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