News & Analysis as of

Compliance Dept. of Health and Human Services

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -

OIG Unveils New Work Plan Process: Assessing the Impact on Compliance Risk Assessment

by Baker Ober Health Law on

On June and July 17, 2017, the Department of Health and Human Services, Office of Inspector General (OIG) released new Work Plan initiatives and, in doing so, announced its intent to update its Work Plan monthly, in lieu of a...more

"Meaningfully Useful" Risk Mitigation Strategies for Providers Following the eClinicalWorks Settlement

by Jones Day on

The Health Information Technology for Economic and Clinical Health Act ("HITECH Act") established financial incentives under Medicare and Medicaid for eligible health care providers that adopt, implement, and demonstrate use...more

Grant and cooperative-agreement recipients: Are your procurement standards compliant yet?

by Thompson Coburn LLP on

Local governments, Native American tribes, institutions of higher education, or non-profit organizations (including health care organizations) that receive grants or cooperative agreements (or part of either type of Federal...more

Why Healthcare and Life Sciences Companies Need to Step Up Their Compliance Efforts in Advance of a U.S. Government Investigation

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells partner Gejaa Gobena discusses how the perception of compliance, remediation, and self-disclosure has evolved in the eyes of government prosecutors from how they factor at...more

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

by Bilzin Sumberg on

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

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