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Delaware Health Law Blog

New Guidance on Mobile Device Security for Health Care Providers

At the end of July the National Institute of Standards and Technology of the U.S. Department of Commerce (“NIST”) released a draft practice guide, Securing Electronic Health Records on Mobile Devices, that demonstrates how health care IT professionals can use existing technologies, including commercially available and open source tools, to better protect electronic protected health information (“ePHI”) systems and facilitate secure sharing of ePHI through mobile devices. According to the guide, “many health care providers are using mobile devices in health care delivery before they have appropriate privacy and security protections in place.” The guide is intended to provide a technical roadmap for achieving HIPAA-compliant use of mobile devices by health care professionals.

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Governor Markell Signs Delaware Medical Orders for Scope of Treatment Act

On May 28thGovernor Markell signed House Bill No. 64, the Delaware Medical Orders for Scope of Treatment or “DMOST” Act. The legislation establishes a clinical process to facilitate communication between an adult patient with a “serious illness or frailty” and the patient’s physician (or other health care practitioner licensed to write medical orders under Title 24 of the Delaware Code) who “would not be surprised if [the patient] died within the next year” regarding what life-sustaining treatments, if any, the patient wishes to receive. Based on that consultation, the legislation allows the physician to complete a DMOST form documenting the patient’s wishes as a medical order intended to be honored by personnel attending the patient in any health care setting, including the patient’s home, a health care institution, or by emergency personnel.

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Delaware General Assembly Passes Telemedicine Bill

On May 14th the Delaware General Assembly passed HB 69 amending Title 18, the state’s Insurance Code, and Title 24, governing health care professions and occupations, to facilitate the use of “telehealth” and “telemedicine” in the delivery of health care to patients located in Delaware. The bill defines “telehealth” as “the use of information and communications technologies consisting of telephones, remote patient monitoring devices or other electronic means which support clinical health care, provider consultation, patient and professional health-related education, public health, health administration, and other services as described in regulation.”

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Medicare Enrollment Deadline Looms for Delaware Dentists

Most dentists have never had the need to consider Medicare enrollment, based on the fact that Medicare Part B covers a small amount of dental services (for example, services that are an integral part of a covered procedure and for extractions done in preparation for radiation treatment for neoplastic diseases involving the jaw). But for the many dentists who treat Medicare patients with Part D prescription drug plans, June 1, 2015 marks an important deadline.

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U.S. Supreme Court Rules Against Medicaid Providers Seeking Higher Reimbursement Rates

In a 5-4 decision issued on March 31, 2015, the U.S. Supreme Court ruled that Medicaid providers cannot sue state Medicaid agencies pursuant to Section 30(A) of the Medicaid Act for failure to raise reimbursement rates. A January 20, 2015 post on this blog describes the background of the case, Armstrong v. Exceptional Child Center, Inc. Justice Scalia, writing for the majority, opined that the Supremacy Clause of the U.S. Constitution does not provide a basis to imply a private right of action to enjoin a state law or regulation that is inconsistent with federal law.

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Negative OIG Advisory Opinion Regarding Exclusive Arrangements Between Labs and Physician Practices

On March 25, the Department of Health and Human Services Office of Inspector General (“OIG”) released Advisory Opinion 15-04 in which it concluded that an exclusive arrangement between a laboratory (“Requestor Lab”) and physician practices could generate prohibited remuneration under the anti-kickback statute. Furthermore, the OIG concluded that the proposed arrangement could violate the prohibition on charging Federal health care programs substantially in excess of usual charges, for which a provider may be excluded from participation in Federal health care programs.

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Delaware Drug-related Regulatory Updates

Drug-related revisions to the regulations governing nurses and pharmacists practicing in Delaware took effect on March 11, 2015. For nurses, “unprofessional conduct” that may lead to disciplinary action now expressly includes diverting, possessing, obtaining, supplying or administering illegal drugs. For pharmacists, a new regulation expressly requires that dispensed medications returned to a pharmacy “by the public” must be disposed of in accordance with Delaware and federal controlled substances laws, and “proposed disposal methods must be authorized by the Delaware Office of Controlled Substances and federal authority.”

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U.S. Supreme Court Affirms: State Licensing Boards Without Active State Supervision Susceptible to Antitrust Suits for Anticompetitive Behavior

On February 25, the US Supreme Court released its decision in North Carolina State Board of Dental Examiners v. Federal Trade Commission, reaffirming the rule that state professional licensing boards controlled by active market participants that are not “actively supervised” by the State do not enjoy state-action immunity from antitrust enforcement. As a result, both regulators and regulated health care professionals may find a need to reevaluate state licensing board activity.

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OIG Issues New Advisory Opinion that Sheds Additional Light on How the Government Views Beneficiary Inducements

The federal Civil Monetary Penalties statute, 42 U.S.C. 1320a–7a, allows the government to impose Civil Money Penalties “(“CMPs”) when it determines that a health care provider has offered remuneration to a federal health care program beneficiary to influence the beneficiary to select the provider for services paid for by Medicare or Medicaid. Similarly, the federal Anti-Kickback Statute, 42 U.S.C. 1320a–7b(b), prohibits offering remuneration in exchange for referrals of federal health care program business.

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U.S. Supreme Court Considers Whether Providers May Sue State Medicaid Officials for Failing to Raise Reimbursement Rates

On Tuesday, January 20, 2015, the United States Supreme Court heard oral argument in a case brought by providers of residential rehabilitation services to Medicaid eligible individuals against the Director and Deputy Director of Idaho’s Department of Health and Welfare (IDHW) challenging IDHW’s failure to raise Medicaid reimbursement rates that had been in effect since July 1, 2006.

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