Healthcare Compliance

News & Analysis as of

Risk in Compliance Week: Part I – Forecasting

This week I will feature a series on risk in compliance where I will be joined by Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment...more

FCPA Recidivists: Orthofix (Part II of II)

In its continuing quest to push the message of aggressive FCPA enforcement, the SEC resolved FCPA charges against Orthofix, a medical device company, for $6 million in penalties and disgorgement. In a related action, the SEC...more

FCPA Recidivists: Zimmer Biomet (Part I of II)

The drug and medical device industries have been taking it on the FCPA chin for years. The risk factors in the international marketplace are significant – healthcare professionals are normally government employees; government...more

Corporate Law & Governance Update - January 2017

The following developments from the past month offer guidance on corporate law and governance law as they may be applied to nonprofit health care organizations: HEALTH POLICY INITIATIVES - Perhaps the most...more

Investing in Cuban Health Care Biotech Industries

The Obama Administration made significant new regulatory changes to allow certain investment opportunities in the Cuban health care and biotech industries. While many barriers remain, US firms in the health care industry...more

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

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

Monster Movie Month: Episode III – Son of Frankenstein and Evolution From Yates Memo and FCPA Pilot Program

Welcome to my third installment in this month’s classic monster movie festival. This year I am revisiting the Frankenstein series. Today I want to explore the final movie where Boris Karloff starred as Frankenstein’s Monster;...more

Headlines from Mid-Year FCPA Enforcement Review

Just to add my voice to the cottage industry surrounding FCPA enforcement and compliance, I wanted to take a deep breath and offer some observations on FCPA enforcement in 2016. There are a few significant headlines...more

The Deeper Dive: Guarding Against Unrealistic Goals and Organizational Pressures That Can Lead to Compliance Failure

When misconduct occurs within an organization, it is often reported and interpreted as an anecdote involving a few rogue employees who are quickly identified and appropriately disciplined. Misconduct derives, at least in...more

Health Care E-Note - November 2015

With medical device related acquisitions at all-time highs, and regulatory interest intense from the Federal Trade Commission, the Food and Drug Administration, the Securities and Exchange Commission, and the Office of...more

OCR Expected to Strengthen HIPAA Enforcement in 2016

Two recent reports issued by the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) recommended that HHS’s Office for Civil Rights (“OCR”) should fully implement a permanent audit...more

CMS Proposes Rules Requiring LTC Facilities to Implement Compliance and Ethics Programs

Under proposed rules issued by the Centers for Medicare and Medicaid Services (CMS), long term care (LTC) facility operators would be required to develop, implement and maintain a comprehensive compliance and ethics program...more

CMS Makes Significant Changes to Stage 2 Meaningful Use and Finalizes Stage 3

On October 16, 2015, the Centers for Medicare & Medicaid Services (CMS) published a final rule (Final Rule) that streamlines Stage 2 and finalizes Stage 3 of the Medicare and Medicaid electronichealth record (EHR) Incentive...more

Recent Amendments to Security Breach Notification Laws Further Complicate Breach Notification for Employers

It is not a matter of "if" but "when" an employer will be required to notify employees of a security breach.  Forty-seven states require employers to notify employees when defined categories of personal information, including...more

Developments in Long-Term Care Q2 2015

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

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

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

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

HELP! FTC Staff Steps Up to the Plate with Guidance for State Officials on Regulating Occupational Boards

Answering the call from state officials seeking advice regarding antitrust compliance for state boards responsible for regulating occupations, Federal Trade Commission (FTC) Staff have stepped up to answer two questions...more

Preparing for the Approaching ACA Reporting Deadlines

With ACA reporting deadlines quickly approaching, many employers should be preparing to address the various reporting requirements in order to avoid the significant fines and penalties associated with non-compliance. As of...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

Meaningful Use Audits: Proactive Tips for Success

For health care professionals who began accepting Meaningful Use incentive money at the outset of availability under the Medicare option in 2011, the year 2015 is an important year. If the provider has met all core...more

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

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

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

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

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