Pharmacy Board Proposed Regulations: The Next Step for Telemedicine in North Carolina

The future of telemedicine has become a hot topic in the health care industry nationwide, and the momentum seems to be in telemedicine’ s favor.   Indeed, the North Carolina Medical Board recently issued revised policy statements that loosened restrictions on prescribing medication through a telemedicine encounter.

Although the Medical Board’s position represented a major sea change, an existing regulation applicable to pharmacists licensed in North Carolina has made those changes difficult to implement.  Specifically, North Carolina Rule 21 NCAC 46.1801 bars a pharmacist, except in limited circumstances, dispensing prescription drugs if the pharmacist has knowledge that the prescriber has not conducted a physical examination of the patient.  Although, as a practical matter, a pharmacist would likely not know whether a physical examination has occurred, there have been several reported cases of pharmacists refusing to dispense medication after learning from their customers that the orders were obtained from a telemedicine encounter.

It now appears that the Board of Pharmacy is ready to lift this restriction based on a recently proposed amendment to 21 NCAC 46.1801.  The proposed regulation, which was published in the April 15, 2015 edition of the North Carolina Register, replaces the prohibition on dispensing medication without a physical examination with new language that allows pharmacists  to use their professional judgment to refuse to fill a prescription in cases in which the order’s accuracy, validity, or authenticity or the patient’s safety is at issue.  The revised regulation also states that a prescription order is valid if it is a lawful order, made for a legitimate medical purpose, and in the course of legitimate professional practice “as recognized by the occupational licensing board governing the health care provider.”  This proposed change is important because it expressly incorporates the North Carolina Medical Board’s new position that orders for prescriptions that result from telemedicine examinations are not prohibited but must meet appropriate standards of care.

The proposed effective date of the new regulation is August 1, 2015.  A public hearing on the proposed revision to 21 NCAC 46.1801 will be conducted by the North Carolina Board of Pharmacy on June 16, 2015 at 9:00 a.m.  Further, comments to this proposed regulation may be directly submitted to the Board of Pharmacy.  Given the current tenor of the telemedicine debate in North Carolina and elsewhere,  it is likely that the new regulation will be adopted.  On August 1, 2015 North Carolina will take one more step to embracing what many see as the future of health care.

Robb Leandro

Robb Leandro

Robb Leandro assists his client with a broad range of legal issues relating to health care, administrative law and public policy. His legal practice focuses on helping health care providers navigate the minefield of regulations that they face in their practices. Robb routinely assists his clients with issues including Medicaid and Medicare regulations; Medicaid and Medicare audits; Certificate of Need Applications and litigation; licensure, surveys, and certification issues; and HIPAA and privacy laws. Robb also provides counsel to health care providers with complex government contract procurement issues.

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Cloud Computing Contracts Top Issues for Healthcare Providers

An increasing number of health care providers are outsourcing the hosting and maintenance of software applications, the storage of data, and related support services.  Outsourcing can provide cost savings, rapid deployment, system scalability, other efficiencies, and appropriate data security.  It also introduces additional issues into the provider’s risk management analysis, largely based on the fact that a third party rather than the provider has possession and control of vital and sensitive assets and information.  Before you enter into a contract that includes a cloud computing component, you should consider some of the following:

  • No business decision or activity is risk free.  Risk management is a balancing process based on the particular facts and circumstances.  For example, a provider may be less concerned about its inability to access its web-based job application submission portal than its electronic health record application.  Not all risks are the same, and a provider should devote more attention and resources to managing its greatest risks.
  • Risk management is a team sport.  Effective risk management requires the participation and interaction of representatives of the intended user group, financial analysts, compliance officers, information technology and data security experts, and legal counsel experienced in advising on and negotiating the particular type of contract.

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Steve Hunting

Steve Hunting

Steve has successfully guided health care providers, electric utilities and other clients through complex information technology, transmission, generation and other commercial projects and contract negotiations for more than 25 years. His experience as in-house counsel helps him provide seasoned, practical advice and have a better understanding of the daily challenges his clients face. His objective is to help his clients achieve their business goals effectively and efficiently.

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Physicians Finally Get Permanent Medicare Payment Solution

On April 16, 2015, President Obama signed into law a permanent sustainable growth rate (“SGR”) fix.  The Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) eliminates the Medicare SGR methodology, which has been used to determine annual updates to the Medicare Physician Fee Schedule (“MPFS”).

Background
Initially enacted as part of the Balanced Budget Act in 1997, the SGR was intended to limit Medicare spending on physician services.  However, the SGR methodology has called for negative updates annually since 2002, causing Congress to pass 17 short-term “doc fix” bills since 2003.  In April 2015, MACRA, a permanent fix, passed both chambers with bipartisan support despite the estimated $141 billion increase in federal budget deficit that will be attributed to it over the next 10 years.  This new model incorporates a move from fee-for-service to pay-for-performance for physician services.

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Varsha Gadani

Varsha Gadani

Varsha Gadani focuses her practice on the health care industry. Her clients include hospitals, physicians, behavioral health care providers, long-term care facilities, and other providers. Prior to joining Parker Poe, Ms. Gadani served as Assistant Counsel at the North Carolina Medical Society (NCMS). In this role, she performed a variety of legal functions for the NCMS. She monitored and analyzed emerging state and federal health law issues and advised physicians on health policy matters.

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