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Health Law Alert
2010 Volume 2
DEA Restates Position on Authorized Prescriber Use of Agents in Long Term Care Facilities
The federal Drug Enforcement Administration (DEA) recently responded to broadly voiced concerns about the agency's rigorous interpretation and enforcement of its regulations governing the use by physicians and other authorized prescribers of the staff of long term care facilities and hospices to transmit prescriptions for controlled dangerous substance (CDS) to pharmacies. Many have believed it to be an acceptable practice for nursing staff of such providers to accept orders, whether verbal or written, for CDS from authorized prescribers and to transmit them to the pharmacy to be filled. In fact, this practice generally has been believed to be the industry standard.
Unlike hospitals, long term care facilities and hospices are not DEA "registrants" authorized to administer and dispense CDS. As such, they are dependent on having access to an authorized prescriber with a federal DEA registration in compliance with the applicable federal regulations that enable a pharmacy to dispense needed CDS. The DEA, in guidance and through recent investigative actions, has stated its position in a way that would prohibit the practice pursuant to which authorized prescribers write monthly or other orders including CDS, or call facility staff with verbal CDS orders that are later countersigned, so that staff can obtain and administer those CDS to patients. The result is that facilities are unable to secure CDS for patients unless the physician directly provides a signed prescription to the pharmacy, except in emergencies where a verbal order and countersignature may be used. This has resulted in delays affecting long term care facility and hospice residents.
Click to continue...HIPAA: The New Enforcement Culture
By: James B. Wieland
The culture of HIPAA compliance is about to change, driven by significant changes in the law. The OIG has been encouraging a "culture of compliance" with the antikickback laws for a number of years, which has resulted in a general awareness in clinical laboratories. Most in the health care industry, for example, know that giving a physician something of value to reward referrals is not acceptable. Few are likely to know what the foundation for compliance with the HIPAA Security Rule is, but that is changing as well.
The HIPAA Security Rule, which is basically a series of technologically neutral touch points for developing HIPAA-compliant processes and procedures for safeguarding protected health information in electronic form (ePHI) has been in effect for nearly 10 years now, but has generally received less attention than has the HIPAA Privacy Rule. The federal HIPAA enforcers have published a draft of their first annual guidance on the provisions of the HIPAA Security Rule: HIPAA Security Standards: Guidance on Risk Analysis (the Draft Guidance). Under the HIPAA Security Rule, it is not enough to be secure; documentation of the decision-making process that led each clinical laboratory or other HIPAA-covered entity to select the means of achieving security for ePHI at rest in or transmitted by the covered entity is required. The risk assessment is described in the Security Rule as "an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of e-PHI held by the covered entity."
Click to continue...Physician Payment Sunshine Act
The Patient Protection and Affordable Health Care Act (H.R. 3590) signed into law in March 2010 includes the Physician Payment Sunshine Act (section 6002) (PPSA), which requires pharmaceutical, medical device, biological, and medical supply manufacturers to report to Health and Human Services (HHS) any "payment or other transfer of value" to physicians and teaching hospitals. The first reports will be due March 31, 2013 for the calendar year 2012 reporting period.
The report must include information about the amount of the payment, the date on which the payment was made, the form of payment, and the nature of the payment (e.g., gift, consulting fees, entertainment). The PPSA specifically excludes certain transfers of value from this disclosure requirement.
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