Health Care Providers Compliance

News & Analysis as of

Top Ten International Anti-Corruption Developments for August 2016

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Put the Candle Back: the AstraZeneca FCPA Enforcement Action

I am back from a two-week summer study program at Oxford, run by Michigan State University through its Odyssey to Oxford program. It was a great experience. My class was on The Tudors in film and print so not only did I...more

[Webinar] Cloud licensing and health care data: Know the risks, learn the solutions - July 13th, 12:00pm CT

As identity theft and malicious attacks against clinical providers increase, more and more health care data is stored in the digital cloud. The health care industry is required to take special precautions when licensing...more

OIG Issues New Exclusion and CIA Guidance

On April 18, 2016, Inspector General Daniel R. Levinson announced the publication of updated guidance on how the Office of Inspector General (OIG) makes decisions about using its permissive exclusion authority and requiring...more

Novartis FCPA Enforcement Action, Part II

Yesterday, I used a quotation from the Oscar winning animator, Chuck Jones who described two of his well-known creations, Roadrunner and Wily E. Coyote, by referring to philosopher George Santayana’s description of fanaticism...more

Novartis Coughs Up $25 Million to SEC for China FCPA Violations

Last week, the SEC announced another FCPA settlement involving the pharmaceutical industry for bribery in China. The SEC’s settlement filing represents yet another example of the pharmaceutical industry run amok in China,...more

Novartis FCPA Enforcement Action, Part I

The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more

Drug and Medical Device Corruption Risks in China

Medical device and pharmaceutical companies know the risks of conducting business in China. Company after company has had to settle FCPA enforcement actions in China. Many of these enforcement actions include fact patterns...more

The Role of Health Care Directors in Compliance: A Practical Approach to Compliance Oversight and Responsibilities

Cathy Martin of Ober|Kaler's Health Law Group co-presented "The Role of Health Care Directors in Compliance: A Practical Approach to Compliance Oversight and Responsibilities" at the Annual Spring Conference of the Maryland...more

Health Care Enforcement in 2016: A Look Back on 2015 and Forecasting the Year Ahead

2015 was a year of transition for the U.S. Department of Justice (“DOJ”), with the installation of a new Attorney General, Deputy Attorney General, and several other high-level officials. In January 2015, Andrew Weissmann...more

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

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

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

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

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

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

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

OIG Reports Insufficient Oversight Of HIPAA Compliance

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

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Market Allocation = Antitrust Consequences

The U.S. Department of Justice and the State of Michigan recently initiated a civil antitrust action to enjoin certain marketing agreements between four south-central Michigan hospital systems alleging that the agreements...more

Bristol-Myers Squibb FCPA Enforcement Action

Yesterday, the Securities and Exchange Commission (SEC) announced a Foreign Corrupt Practices Act (FCPA) enforcement action against Bristol-Myers Squibb Company (BMS) for the actions of the company’s joint venture (JV) in...more

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

HHS Proposes Rules for Nondiscrimination in Health Care

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

Illinois Enacts Patient Notification Requirement for Observation Stays

Illinois joins a growing number of states to pass laws requiring that hospitals provide notice to patients who are placed under observation status. 210 ILCS 86/6.09b As with the recent federal NOTICE Act, the laws respond to...more

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

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

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