OIG Rings in the New Year With New Anti-Kickback Statute Safe Harbors

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Just in time for the New Year, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued final regulations (Final Regulations) that revised two existing Anti-Kickback Statute safe harbors, added two regulatory safe harbors to complement existing statutory safe harbors, and created an entirely new safe harbor regarding local transportation services.  These regulations, which became effective on January 6, 2017, finalized the proposed regulations that OIG released on October 3, 2014.  OIG received comments from 88 distinct commenters in response to the proposed regulations and made several changes to the proposed regulations in response to the comments received.

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Florida Board of Medicine Hearing on Telemedicine and Medical Marijuana

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The Florida Board of Medicine will hold a public hearing on February 3, 2017 to discuss its proposed amendment to Florida’s telemedicine practice rules.  The proposed amendment, published December 8, 2016, is intended to clarify that physicians may not order medical cannabis or low-THC cannabis via telemedicine.

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

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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 monetary penalty of up to $5,000 for each instance of overcharging. The regulation finalizes a proposal dating back to June 2015. The regulation will be enforced beginning on April 1, 2017. Continue reading this entry

The Joint Commission Bans Text Messaging for Patient Care Orders

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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 independent practitioners to text orders for patient care, treatment, or services to hospitals or other health care settings.  The Joint Commission reversed its position in May 2016, stating providers could “text orders as long as a secure text messaging platform is used and the required components of an order are included.”  The Joint Commission credited the evolution of health care communications technology as part of the reason for its decision to reexamine and allow provider text messaging.  Then, in July 2016, the Joint Commission “hit unsubscribe” on its guidance and delayed the use of text messaging until it had time to further consider the clinical and operational implications. Continue reading this entry

Hawai’i Receives Approval for the First State Innovation (Section 1332) Waiver

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The federal Department of Health and Human Services and Department of Treasury (the Departments) agreed that certain small employer health insurance coverage provisions of the Affordable Care Act (ACA) would be waived for the state of Hawai’i, beginning with January 1, 2017. The waiver was authorized pursuant to Section 1332 of the ACA, which allows states to apply for a State Innovation Waiver. Continue reading this entry