News & Analysis as of

Health Update - June 2016

Real-Time Data Analytics in Government Investigations and Reducing Exposure - It is not every day that the words “innovative” and “nimble” are used when referring to an agency of the federal government bureaucracy. Yet,...more

Significant Hospital Related Mid-Year Updated OIG Review Activities

This is the second of three alerts discussing the mid-year update to the Fiscal Year 2016 Work Plan issued by the Office of Inspector General (OIG). In the first alert we discussed the top management performance challenges...more

Why the FDA Needs to Change Its Food Recall Policies

Add this to FDA’s growing list of things to do: improve the food recall initiation process. According to a memorandum published on June 8, 2016, the Office of Inspector General (OIG) of the Department of Health and Human...more

OIG Releases Mid-Year Update to its FY 2016 Work Plan

The HHS OIG has updated its FY 2016 Work Plan to reflect new and/or completed items since initial release of the FY 2016 Work Plan in November 2015. For instance, the mid-year update indicates that the OIG plans to conduct...more

OIG Mid-Year Updated Provides Insight To Its Concerns

The Office of Inspector General (OIG) recently released its mid-year update of its Fiscal Year Work Plan for 2016. The Work Plan summarizes new and ongoing reviews and activities that the OIG plans to pursue. Not...more

Health Law Insights Newsletter - Issue 10 - June 2016

McCarter & English, LLP’s Health Care Group presents Issue 10 of the Health Law Insights, which discusses the latest legal issues in the health care industry. NATIONAL - Drug Diversion Case Raises Red Flags for...more

Free Transportation Gets Another Nod from OIG

On March 1, 2016, the Department of Health and Human Services Office of Inspector General once again issued a favorable advisory opinion for the provision of free transportation by a healthcare facility. In this instance, an...more

OIG Spring 2016 Semiannual Report to Congress Highlights Enforcement/Investigative Accomplishments

The OIG has issued its Spring 2016 Semiannual Report to Congress, which describes significant enforcement and investigative activities relating to HHS programs during the first half of FY 2016 (October 1, 2015 – March 31,...more

Another Medigap/Preferred Hospital Network Arrangement Approved by OIG in Advisory Opinion 16-05

On May 3, 2016, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued another favorable advisory opinion, No. 16-05 [PDF], regarding an agreement between a Medicare Supplemental Health...more

AGG Food and Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

OIG Issues Favorable Advisory Opinion Regarding Proposed Ownership Structure of Group Purchasing Organization

On May 2, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) issued a favorable advisory opinion regarding a proposed arrangement, under which a group purchasing organization (GPO)...more

U.S. Department of Health and Human Services Updates Criteria for Permissive Exclusion Under Section 1128(b)(7) of the Social...

The HHS-OIG issued new guidelines on April 18, 2016 regarding the Secretary's exercise of the Department's permissive exclusion authority pursuant to Section 1128(b)(7) of the Social Security Act. The HHS-OIG's new guidance...more

Blog: OIG Releases Criteria For Implementing Exclusion Authority

On April 18, 2016, the Health and Human Services Office of Inspector General (OIG) released updated guidance related to the criteria it may use for evaluating its permissive exclusion authority under Section 1128(b)(7) of the...more

"New HHS OIG Criteria to Guide Resolution of Health Care Investigations"

The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more

New Guidance on Exclusion

For the first time in nearly 20 years the Office of Inspector General (OIG) of the Department of Health & Human Services has issued new guidance on the exercise of its authority to exclude health care providers from...more

OIG Continues its Focus on GIP Abuse: What Hospice Providers Need to Know

On March 31, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report on hospice billing for general inpatient care (GIP). According to the OIG, hospices billed Medicare for...more

OIG laments failure to comprehensively address EHR fraud

The U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) recently released a compendium (Compendium) of its top unimplemented recommendations. The Compendium comprises 25 unimplemented past OIG...more

OIG Identifies Top 25 Unimplemented Recommendations for HHS Cost Savings/Quality Improvements

The OIG has released the 2016 edition of its “Compendium of Unimplemented Recommendations,” which identifies what the OIG considers to be its top 25 unimplemented recommendations in terms of HHS program savings and/or quality...more

To Refer, Or Not To Refer? OIG’s Outdated Health Care Referral Restrictions

The Office of the Inspector General, which enforces Health and Human Services, has long been averse to referral services that don’t meet certain criteria. To get protection against a possible enforcement action, the referral...more

OIG rules hospital's offer of free transportation, lodging doesn't violate anti-kickback statute

The Office of Inspector General of the Department of Health and Human Services recently posted an Advisory Opinion describing a proposed arrangement by an academic medical center that offers free transportation and lodging to...more

OIG Approves Free Transportation and Lodging for Certain, Low-Income Pregnant Women - Advisory Opinion 16-02

On March 1, 2016, the Department of Health and Human Services, Office of Inspector General (OIG) issued Advisory Opinion 16-02 [PDF], approving an academic medical center's (AMC's) provision of free transportation and lodging...more

Manatt on Health Reform: Weekly Highlights - March 2016

STATE STAFFING UPDATES: Nevada: New Insurance Commissioner Appointed - The Director of Nevada's Department and Industry announced Barbara Richardson as the Commissioner of the Division of Insurance. Richardson...more

Increased Scrutiny of Drug Pricing What Should Pharmaceutical Companies Know

As U.S. spending on pharmaceuticals continues to rise, reaching $373.9 billion in 2014, government scrutiny of drug pricing practices has increased in response. Early last year, the U.S. Department of Health and Human...more

Recent Corporate Integrity Agreements Highlight HHS OIG’s Compliance Program Priorities

Corporate Integrity Agreements (CIAs) are among the most important tools in the U.S. Department of Health and Human Services Office of Inspector General’s (OIG) toolbox for promoting compliance in the health care industry....more

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