An administrative law judge with the Departmental Appeals Board (DAB) granted summary judgment in favor of the Centers for Medicare and Medicaid Services after determining that the petitioner, Shiloh First Health Care, Inc., violated federal regulations when a nurse for Shiloh re-used lancets on multiple Medicare and Medicaid beneficiaries, creating a great risk of harm to the beneficiaries (Shiloh First Health Care, Inc. v. CMS, Docket No. C-17-187, Decision No. CR5052, March 20, 2018).
Issues. The issues presented were whether Shiloh "failed to comply substantially with a condition governing a home health agency’s participation in Medicare and whether a per-instance civil money penalty of $10,000 is reasonable."
Findings. The ALJ found that a nurse for Shiloh re-used lancets—a fingerstick device that contains a needle that punctures the skin in order to produce sufficient blood in order to measure blood sugar levels—on multiple Medicare and Medicaid beneficiaries and that there is a possibility "that blood-borne pathogens, including pathogens that cause hepatitis, may be transmitted in this manner," posing a great risk of harm to the beneficiaries.
Civil remedies. The ALJ also noted that the regulations authorize the imposition of civil monetary penalties that may range from $1000 to $10,000 and, after reviewing the penalty imposed on Shiloh in the context of regulatory criteria, found Shiloh’s noncompliance in the re-use of lancets violated all accepted standards of nursing practice and was "especially egregious," because the re-use of lancets—even when a practitioner attempts to disinfect them between uses—is specifically prohibited by applicable guidelines published by the Centers for Disease Control and the CMS and placed beneficiaries at great risk.
Holding. The ALJ held that Shiloh violated the requirements Set forth in 42 C.F.R. § 484.30 which requires home health agency services "meet professionally recognized standards of care, described in the regulation as appropriate preventative and rehabilitative procedures," and sustained the per-instance fine of $10,000 that the CMS imposed on Shiloh, stating that the fine "is entirely reasonable given the potentially dangerous consequences of Petitioner’s noncompliance."
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