Arkansas' New Telemedicine Rules a Small Step Forward

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The Arkansas Legislative Council’s Rules and Regulations Subcommittee approved, on August 16, 2016, proposed regulations which, if accepted by the Arkansas Legislative Council, will remove some restrictions on telemedicine providers in a state that enjoyed the lowest ranking among all states in the American Telemedicine Association’s most recent report.

Currently, Arkansas Code 17-80-117, enacted in April 2015, and Regulation No. 2(8), require an initial in-person encounter to establish a valid physician-patient relationship. Following the issuance of draft rules last October and the release of proposed amendments in April, the Legislative Subcommittee gave its final approval in August to amend Arkansas’ prior practice standards for telemedicine by revising the text of Regulation No. 2(8)(A) and (B). These amendments allow a doctor to establish a valid relationship with a patient, without the need for an in-person exam, if the doctor “performs a face to face examination using real time audio and visual telemedicine technology that provides information at least equal to such information as would have been obtained by an in-person examination.” The revised regulation will become effective August 26. Continue reading this entry

Missouri Governor Signs New Telemedicine Law

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Missouri’s governor signed into law SB 579 (the “Act”), on June 8, 2016, establishing new telemedicine practice standards, including explicitly allowing a valid physician-patient relationship to be established via telemedicine. Here is a summary of the Act’s key provisions: Continue reading this entry

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

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Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes between 340B Program covered entities and drug manufacturers. As proposed, the ADR process would be available for covered entities to submit claims that they have been charged for covered outpatient drugs amounts higher than the 340B Program ceiling price, and for drug manufacturers to claim that covered entities have violated the 340B Program prohibitions on the diversion of 340B drugs to persons who are not eligible patients or the prohibition on duplicate discounts. For manufacturers to bring a claim to the ADR they must have first conducted an audit of the covered entity. Publication of this proposed process has been long delayed, and is of great interest to 340B Program stakeholders. Comments on the proposed rule are being solicited, and are due October 11, 2016. Continue reading this entry

South Carolina Enacts New Telemedicine Law: What You Should Know

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South Carolina Governor, Nikki Haley signed the South Carolina Telemedicine Act (S.B. 1035) into law, on June 3, 2016, establishing new telemedicine practice standards in the Palmetto State. Prior to the Act, the controlling guidance was South Carolina Code § 40-47-113 and the South Carolina Board of Medical Examiners’ 2015 Advisory Opinion on Telemedicine and 2013 Advisory Opinion on Establishment of Physician-Patient Relationship as Prerequisite to Prescribing Drugs. Continue reading this entry

Mid-Year 340B Program Update

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Since our last 340B Drug Pricing Program (340B Program) update, the U.S. Centers for Medicare & Medicaid Services (CMS) has issued two regulations, the final Medicaid managed care regulation and a proposed update to the Medicare outpatient prospective payment schedule to implement new site neutrality requirements, that impact the 340B Program.  Providers participating in the 340B Program (covered entities), as well as their contract pharmacies and other stakeholders such as drug manufacturers, state Medicaid agencies, and Medicaid managed care plans, should be aware of the potential changes that may occur as these rules become effective.  Additionally, the Health and Human Services Office of Inspector General (OIG) recently issued a report making recommendations related to the 340B Program that could also affect 340B Program policy.  In addition, the Health Resources and Services Administration (HRSA) expects to publish significant new 340B Program regulations and guidance later this year.

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