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

Court Slams Medicare Agency, Notes Reputation As “Unfeeling Bureaucracy”

The Department of Health & Human Services’ Provider Reimbursement Review Board (Board) came in for some withering criticism last Friday from the federal court hearing the appeal of University of Chicago Hospital from the...more

News from the Health Law Gurus™

Former Walmart Exec to Help Manage HHS — Leslie Dach, former Executive Vice President of Corporate Affairs for Walmart, will assume the role of Senior Counsel of the HHS, according to a press release on Wednesday. ...more

Are your HIPAA ducks in a row? The next round of OCR HIPAA audits is approaching

In 2011 the Department of Health and Human Services’ Office for Civil Rights (OCR) established the HIPAA Pilot Audit Program to ensure compliance with HIPAA’s privacy, security and breach notification rules. The first...more

Hospitals File Lawsuit Over Medicare ALJ Hearings Delays

Over 460,000 appeals requesting hearings before an administrative law judge (ALJ) were pending in the Office of Medicare Hearings and Appeals (OMHA) at the end of 2013, with 15,000 new appeals being submitted each week. At...more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more

Health Care Update - July 2014 #3

In This Issue: - First Guidance following Hobby Lobby released - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State...more

Energy & Environment Update - July 2014 #2

In This Issue: - Energy and Climate Debate - Congress - Administration - Department of Commerce - Department of Energy - Department of Health and Human Services - Department of...more

The Orphan Drug Wars: HHS Interpretive Rule Clarifies Orphan Drug Exclusion

On July 21, 2014, the U.S. Department of Health and Human Services (HHS) released an “Interpretive Rule” in response to a recent U.S. District Court decision that vacated the July 23, 2013, orphan drug rule on the grounds...more

Health Care Reform Implementation Update - July 2014

Last week the Senate debated a bill to reverse the Supreme Court’s contraception mandate decision, a group of House Republicans introduced a bill to replace Affordable Care Act (ACA) cuts to the Medicare home health benefit...more

HIPAA Violations Will Soon Be More Expensive

The U.S. Department of Health and Human Services (HHS) intends to use higher fines and a new round of audits to send a strong message to the healthcare industry about complying with the Health Insurance Portability and...more

OIG issues special fraud alert on laboratory payments to referring physicians

On June 25, 2014, the U.S. Department of Health and Human Services Office of the Inspector General (“OIG”) released a Special Fraud Alert addressing Laboratory Payments to Referring Physicians. ...more

Medicaid Claims And Health Care Fraud: As The Data Flows, New Cracks Emerge

As we noted in two of our prior posts in the Insider blog, the government has long touted its ability to rely upon data mining as a means of detecting fraud in the federal health care system, and has initiated a host of...more

HHS Announces $83.4 Million in Funding to Train New Primary Care Providers

On July 7, 2014, HHS Secretary Sylvia Matthews Burwell announced that HHS would be awarding $83.4 million under the Teaching Health Center Graduate Medical Education (THCGME) program administered by the Health Resources and...more

D.C. Circuit Overturns PRRB’s Decision that Only Newly Built Hospitals Can Qualify for Favorable Capital Reimbursement Rates

In Select Specialty Hospital – Bloomington, Inc. v. Burwell, No. 15-5355 (D.C. Cir., Jul. 8, 2014), a group of long-term care hospitals (LTCHs) successfully challenged the Secretary’s determination that they were not “new...more

OIG Report Recommends Increased Scrutiny of Over 1000 Laboratories With Questionable Billing for Medicare Part B Clinical...

According to a recently released report by the HHS Office of Inspector General (OIG), over 1,000 labs had unusually high billing for Medicare Part B Clinical Laboratory Services for dates of service in 2010. Increased...more

OIG Sticks It to Physician Specimen Collectors

On June 25, the U.S. Department of Health & Human Services, Office of the Inspector General ("OIG") issued a Special Fraud Alert updating the previous guidelines concerning compensation by clinical laboratories to referring...more

Health Care Reform Implementation Update - July 2014

On June 30, in one of the most highly anticipated cases affecting the Affordable Care Act (ACA), the Supreme Court ruled that closely held companies could assert a “religious objection” to the ACA contraceptive coverage...more

New OIG Special Fraud Alert Aimed at Laboratory Payments to Referring Physicians

On June 25, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert entitled "Laboratory Payments to Referring Physicians."...more

New OIG Special Fraud Alert Focuses on Suspect Practices of Labs and Referring Physicians - Certain Payment Arrangements May Be a...

The U.S. Department of Health and Human Services' Office of Inspector General (OIG) issued a new Special Fraud Alert on June 25, 2014, that focuses on certain compensation arrangements between laboratories and referring...more

Got A Complaint About RAC Audits? Get In Line

Criticism of the RAC (recovery audit contractor) program is becoming a national pastime. Needless to say, hospitals hated the program from the very beginning. And little wonder. The program pays private contractors a...more

Medicare's Proposed Home Health Rule for 2015: CMS Suggests Only Limited Relief to the Face-to-Face Encounter Documentation...

On July 7, 2014, the Centers for Medicare & Medicaid Services ("CMS") published proposed changes to the Medicare Home Health Prospective Payment System ("HH PPS") for calendar year 2015 ("Proposed Rule"). The Proposed Rule...more

Do Subsidized Health Care Plans Purchased Under the Affordable Care Act Trigger the Anti-Kickback Statute?

The advent of federally subsidized private pay health insurance under the Affordable Care Act has the potential to expand the application of the federal anti-kickback statute beyond just Medicare, Medicaid, and Tricare. The...more

Employee Benefits: Important Wellness Plan and Mental Health/Substance Use Disorder Parity Effective Dates Have Arrived!

Employers and insurers offering medical plans: take note! Two important final regulations issued jointly by the IRS, DOL and HHS (the “Departments”) apply to plan years (or, in the individual market, policy years) beginning...more

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