News & Analysis as of

Dept. of Health and Human Services Compliance

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 -

OIG Releases “Resource Guide” Regarding Measuring Compliance Program Effectiveness

by King & Spalding on

On March 27, 2017, in conjunction with the Health Care Compliance Association annual Compliance Institute, HHS OIG released a Resource Guide for the healthcare industry to facilitate the consideration of potential options for...more

Compliance 2.0 and the Significance of HHS OIG’s 2017 Resource Guide: “Measuring Compliance Program Effectiveness”

by King & Spalding on

On March 27, 2017, in conjunction with the Health Care Compliance Association (“HCCA”) annual Compliance Institute (“CI”), the Department of Health and Human Services (“HHS”), Office of the Inspector General (“OIG”) released...more

New Guidance Offers Deep Dive Into Compliance Issues

Following up on DOJ’s recent memo on “Evaluation of Corporate Compliance Programs,” the Office of Inspector General at the U.S. Department of Health and Human Services released its own compliance program evaluation memo last...more

OCR Identifies Continuing HIPAA Enforcement Issues, Areas of Future Guidance and Regulations

Last week the Health Care Compliance Association hosted its annual “Compliance Institute.” Iliana Peters, HHS Office for Civil Rights’ Senior Advisor for HIPAA Compliance and Enforcement, provided a thorough update of HIPAA...more

DOJ Issues New, Practical Guidance on Effective Corporate Compliance Programs

by Dorsey & Whitney LLP on

On February 8th, the Department of Justice (DOJ) Criminal Division, Fraud Section issued new guidance on how it evaluates the effectiveness of a corporate compliance program when conducting an investigation of a corporation....more

Managing the Transition to Transformation: Old Dog, New Tricks: Fraud and Abuse in the Age of Payment Reform

by McDermott Will & Emery on

McDermott’s Managing the Transition to Transformation series is designed to help health systems and other health care industry leaders address the many challenges presented by the transformation in payment and care delivery...more

Olympus Settles FCPA Charges with DOJ

by Dorsey & Whitney LLP on

The Department of Justice resolved another FCPA investigation centered on payments made to health officials. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, Tokyo, Japan, and Olympus...more

2016 Trends #3: Board Expectations for Ethics & Compliance Oversight Get More Specific, Uniform and Comprehensive

by NAVEX Global on

According to the U.S. Sentencing Guidelines for Organizations—and similar provisions found in other guidelines worldwide—an organization’s governing body is responsible to “exercise reasonable oversight with respect to the...more

Developments in Long-Term Care Q2 2015

by Hodgson Russ LLP on

The following summary highlights key federal court developments and administrative decisions involving skilled nursing facility survey and related issues during the second quarter of 2015....more

OIG Hospital Compliance Audits: Is Your Number Up? Are You Ready?

by Baker Donelson on

In its Work Plan for Fiscal Year 2012, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced it would begin reviews of Medicare payments to hospitals to determine compliance...more

Alphabet Soup and Data Security

In the span of two days, mobile device users learned of two data breaches that could compromise their personal data. In one, Experian (a credit reporting agency) reported that it was hacked, potentially putting 15 million...more

OCR portal designed for medical mobile app developers

The Office for Civil Rights (OCR) of the Department of Health and Human Services has launched a web based portal so medical mobile app developers can ask their “burning” questions about HIPAA compliance....more

Privacy, Security, Risk: What You Missed At IAPP Conference

by Orrick - Trust Anchor on

Earlier this month, privacy and security professionals from around the globe gathered for “Privacy. Security. Risk. 2015”—the second joint conference between the International Association of Privacy Professionals and the...more

HIPAA Fine Underscores OCR’s Focus on Physician Group Compliance

by BakerHostetler on

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced a $750,000 fine and resolution agreement, including a Corrective Action Plan (CAP), for Cancer Care Group, P.C. (CCG), a...more

OIG Reports Insufficient Oversight Of HIPAA Compliance

by King & Spalding on

The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more

Is Your HIPAA Compliance Program Ready for the FTC?

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

OIG report spurs OCR to announce phase 2 audits

On September 29, it was revealed that the HHS Office for Civil Rights (OCR) will commence Phase 2 of its HIPAA audit program in “early 2016.” OCR’s revelation regarding the Phase 2 audits, which had been the subject of...more

Reports Instruct Office of Civil Rights to Increase HIPAA Enforcement Activities

by Saul Ewing LLP on

On September 29, 2015, the Office of Inspector General (OIG) released two reports that reviewed the Office of Civil Rights’ (OCR) enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The...more

SEC’s Increased Cybersecurity Enforcement and How to Reduce Your Risks

by Perkins Coie on

The SEC announced last week that an investment adviser had agreed to settle charges that it failed to take required steps to protect against and respond effectively to a cybersecurity breach. The action comes on the heels of...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

by Holland & Knight LLP on

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

It’s About Time! 10 Key (Needed) Changes Proposed to the Human Subjects Protection “Common Rule”

by BakerHostetler on

The world has changed drastically since 1991 when Operation Desert Storm was underway; the USSR crumbled; Prince Charles and Princess Diana separated; the World Wide Web was born; gas cost $1.14; and the Dow peaked at 3168....more

HHS Proposes Rules for Nondiscrimination in Health Care

by K&L Gates LLP on

On September 8, 2015, the U.S. Department of Health and Human Services (“HHS”) proposed new regulations implementing Section 1557 of the Patient Protection and Affordable Care Act (“ACA”). Section 1557 prohibits...more

Don’t Wait for It; Recent HIPAA Enforcement Action Signal More to Come in Phase 2 Audits

by Orrick - Trust Anchor on

Officials at the U.S. Department of Health and Human Services Office of Civil Rights (HHS OCR) have recently selected a vendor to conduct the second wave of HIPAA audits. These so-called “Phase 2 Audits” are set to commence...more

OCR Enters into $750,000 Settlement with Physician Practice for HIPAA Violations

by Seyfarth Shaw LLP on

On September 2, the Department of Health and Human Services Office of Civil Rights (OCR) announced a settlement with Cancer Care Group, P.C., a thirteen-physician oncology practice in Indiana related to violations of the...more

Prosecuting Doctors for Medicare Fraud

by Michael Volkov on

Federal prosecutors have turned their attention to physicians for Medicare fraud prosecution. Physicians who participate in the Medicare program have to be aware of the significant risks of Medicare fraud....more

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