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DOJ and OIG Focus on Opioid Abuse: Medical Professionals Who Overprescribe May Be Targets

Two recent announcements reflect that the U.S. Government is taking aggressive steps to address opioid abuse by identifying and targeting the involvement of medical professionals in facilitating opioid abuse involving Federal...more

Update on California’s End of Life Option Act

In June 2016, California became the fifth state to enact an aid-in-dying law. California’s End of Life Option Act (the “Act”) authorizes an adult who is suffering from a terminal disease and meets other qualifications to...more

340B Program Omnibus Guidance Withdrawn

The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program. The...more

HRSA Announces Final Rule on Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

A new regulation issued by the Health Resources and Services Administration (“HRSA”) sets forth a process by which civil monetary penalties may be imposed on drug manufacturers that knowingly and intentionally charge 340B...more

Hospital Text Messaging Rules Placed on Hold by Joint Commission

The Joint Commission, which accredits hospitals and other health care organizations, hit pause on its prior May 2016 announcement to allow secure text messaging in hospitals and other health care organizations. The use of...more

California’s End of Life Option Act: Key Requirements and Considerations

On June 9, 2016, California’s End of Life Option Act (the “Act”) will go into effect. The Act authorizes an adult who is suffering from a terminal disease and meets other qualifications to request an aid-in-dying drug that...more

Is My Telehealth App Subject to HIPAA?

Many telehealth and mHealth app developers are concerned about whether or not their app is a medical device under FDA regulations (and rightfully so), they often pay less attention to the Health Insurance Portability and...more

OIG Releases Compliance Guidance for Health Care Governing Boards

The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“DHHS”) released new compliance guidance for health care governing boards, attorneys, compliance officers and internal auditors on...more

CMS Intends to Modify EHR "Meaningful Use" Program Requirements

The Centers for Medicare & Medicaid Services (CMS) recently announced its intent to engage in rulemaking to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (commonly referred to as the...more

OIG Releases Fiscal 2014 Report to Congress

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS) released its Semiannual Report to Congress (Report) last week summarizing health care fraud investigation activities for the...more

Privacy Issues in the Sharing of Genetic Information

Scientific breakthroughs and technological advancements have led to the emergence of personalized medicine — a practice based on the use of an individual's genetic profile to guide health care decisions made about the...more

New Federal Guidance on Reducing Medicaid Hospital Readmissions

The Agency for Healthcare Research and Quality (AHRQ) recently issued a guide to assist hospitals in reducing Medicaid patient readmissions. The AHRQ Hospital Guide to Reducing Medicaid Readmissions is the product of a...more

HRSA Issues Interpretive Rule on 340B Drug Pricing Program

On July 21, 2014, the Health Resource and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) issued a new interpretive rule addressing the treatment of orphan drugs by certain...more

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