Claire Marblestone

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On July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule introducing changes to the Medicare physician fee schedule, and soliciting comments from providers on CMS data sharing initiatives.  In the proposed rule, CMS requests comments on methods to promote the exchange of health care information between health care providers, and CMS initiatives to encourage price transparency for health care providers and suppliers.…
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 health care program beneficiaries.  The U.S. Department of Justice announced on July 13, 2017 fraud charges involving 412 defendants in 41 federal districts across the country, including 115 doctors, nurses, and licensed professionals.  In what the DOJ asserted was the “largest ever health care…
The US Department of Justice (DOJ) Fraud Section has published new guidance for corporate entities on corporate compliance programs.  The guidance, titled, “Evaluation of Corporate Compliance Programs” (Compliance Program Evaluation)  provides companies – and their compliance teams – with key insights into how government regulators will assess efforts taken to develop, implement and evaluate the program.  The Compliance Program Evaluation provides the first DOJ guidance issued under Attorney General Jeff Sessions and the new administration…
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 request an aid-in-dying drug that may be prescribed for the purpose of ending his or her life.  Cal. Health & Safety Code § 443.2.…
The Federal Office for Management and Budget has withdrawn the proposed omnibus guidance for the 340B Drug Pricing Program (previously referred to as the “Mega-Regs”), creating further uncertainty in the 340B Program.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 guidance was proposed in the Fall of 2015, and would have updated all areas of 340B Program guidance. The guidance would have included significant changes to the definition of an eligible patient, and to 340B Program integrity provisions. By withdrawing the…
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 covered entities for covered outpatient drugs more than the statutory ceiling price. The regulation addresses the ceiling price calculation for drugs purchased pursuant to the 340B Drug Pricing Program (“340B Program”), and provides that drug manufacturers may be subject to a civil…
The Joint Commission, which accredits hospitals and other health care organizations, recently announced it will not permit hospitals and other health care organizations to use secure text messaging platforms to transmit orders. The announcement is the most recent in a back-and-forth series of guidance statements regarding the use of secure messaging in hospitals and other health care organizations. In a 2011 FAQ, the Joint Commission stated it was not acceptable for physicians or licensed…
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 text messaging in Joint Commission accredited organizations is delayed until September 2016. In the interim, The Joint Commission will collaborate with the Centers for Medicare & Medicaid Services to develop guidelines for text-message-based orders to ensure consistency with Medicare’s…
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 may be prescribed for the purpose of ending his or her life.  California is the fifth state to enact a form of an aid-in-dying law.  Similar laws are in place in Oregon, Washington, Montana, and Vermont.…
The Office of Civil Rights (OCR) recently updated the audit protocol that it will be using to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA) privacy, security, and breach notification rules. OCR also released a template that Covered Entities and Business Associates may use to keep track of their business associate relationships. The release of the updated audit protocol and Business Associate tracking template is part of the implementation…