Fall 2006
Compliance with DPW Personal Care Home Regulations Required
The Pennsylvania Department of Public Welfare (DPW) resumed implementation of the Personal Care Home (PCH) regulations in June 2006 after the Commonwealth Court dismissed a challenge to their constitutionality. Shortly after the PCH regulations became effective in October 2005, an association comprised of PCH providers contested the validity of the regulations, in part, due to the greater administrative costs necessary to meet the educational and quality of care criteria imposed. The revised PCH regulations, intended to increase safety and improve resident care, passed the court's critical inspection.
The Court declared the regulations to be in full force and effect without exception such that non-compliance with the PCH regulations may be grounds for an enforcement action. As a result, DPW surveyors will be evaluating PCHs this year based upon their compliance with 55 Pa. Code, Chapter 2600, which includes providing services for activities of "daily living" and instrumental activities of "daily living," and credentialing PCH administrators.
CMS Clarifies and Confirms EMTALA Application to Hospitals without Dedicated ED
In August, the Centers for Medicare and Medicaid Services ("CMS") issued the hospital Inpatient Prospective Payment System, (IPPS) Final Rule for fiscal year 2007. In the Final Rule, CMS clarified that all Medicare-participating hospitals that have specialized capabilities, including specialty hospitals that do not have a dedicated Emergency Department (ED) must accept appropriate transfers of unstable individuals pursuant to the Emergency Medical Treatment and Active Labor Act (EMTALA).
The core purpose of EMTALA, also known as the anti-dumping statute, is to ensure that patients who might otherwise go untreated, get into the medical system and are provided at least stabilizing treatment in the event of an emergency.
EMTALA regulations have been modified at §489.24(f) to confirm that those hospitals with specialized capabilities, while perhaps not subject to EMTALA screening and/or treatment obligations, are subject to the appropriate transfer requirements, and thus have the same responsibility to accept appropriate transfers of unstable individuals as hospitals with EDs. Hospitals with specialized capabilities are not required to open a dedicated emergency department, nor to accept individuals for initial point of entry into the medical system.
Thus, the determination of whether a hospital is deemed a hospital with specialized capabilities has compliance ramifications. The availability of on-call physicians is one of many factors that are considered in determining whether a hospital meets the threshold to qualify as a hospital with "specialized capabilities" under 42 U.S.C. §1395dd(g). Section 1395dd(g) reads: "A participating hospital that has specialized capabilities or facilities (such as burn units, shock-trauma units, neonatal intensive care units, or (with respect to rural areas) regional referral centers as identified by the Secretary in the regulation) shall not refuse to accept an appropriate transfer of an individual who requires such specialized capabilities or facilities if the hospital has the capacity to treat the individual."
Provided a hospital has the capacity to treat an individual, based upon the available hospital facilities and resources to treat, it must accept the appropriate transfer. In its comments to the IPPS Final Rule, CMS stated that its modification of EMTALA regulations does not constitute any change in policy, but merely clarifies the basis upon which CMS has undertaken enforcement actions in the past.
To address the transfer requirements, "specialty hospitals" or hospitals with specialized capabilities without a dedicated ED will need to assess and implement policies to ensure EMTALA compliance. Non-compliance with EMTALA risks the provider's termination from the Medicare program and thus loss of Medicare and Medicaid payments.
No Private Right of Action Implied in HIPAA
The United States District Court for the Western District of Pennsylvania became the third federal district court in Pennsylvania to decline to imply a private right of action in the Health Insurance Portability and Accountability Act ("HIPAA"). In Carney v. Snyder, the district court followed Rigaud v. Garofolo (Eastern District) and Dominic J. v. Wyoming Valley West High School, (Middle District) to hold that HIPAA does not include a private right of action to be enforced against entities or individuals who allegedly release confidential personal health information. Although the Third Circuit has not yet decided the issue, the trend disfavors such a statutory privacy right.
Litigants, including patients and physicians, have sought to use HIPAA to sue providers for damages allegedly suffered as a result of improper disclosure. Recently, a Nebraska court held that a physician cannot sue a hospital for disclosing his prior drug and alcohol treatment under a purported HIPAA privacy right. Though the statute itself does not contain an express private right of action, the courts review both the statute and its implementing regulations to discern whether Congress intended to enable individuals to sue for their rights thereunder, such that a private right of action can be implied.
For the last several years, the federal courts have been inundated with cases by litigants seeking to assert a HIPAA claim against providers or other individuals who have allegedly improperly disclosed personal health information. To date, none of the decisions have held that a private right of action can be implied under HIPAA. Reluctant to expose providers to damages in addition to the civil and criminal penalty provisions under HIPAA, the courts are holding that the Department of Health and Human Services is the only entity that may permissibly impose sanctions for wrongful disclosure. In addition to the penalties provisions, HIPAA's Privacy Rule itself provides specific enforcement mechanisms for aggrieved parties. See 145 C.F.R. § 160.306 (stating an aggrieved party may complain to the Secretary and that the Secretary may investigate the complaints filed under the Section).The fact that neither the statute nor the regulations contains a privately enforceable remedy indicates that there is no private right of action.
Generally, to come to this conclusion the district courts apply the Cort v. Ash standard adopted by the United States Supreme Court in 1975. The absence of a specific legislative intent to create a private right of action for a definable class is the primary reason courts have declined to imply an enforceable right to protect one's health information under HIPAA.
For more information about the topics addressed in this newsletter or for compliance assistance with any of the above statutes and regulations, please contact the author Lucinda C. Glinn at lcglinn@nssh.com.
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