The Neurologists' Program: Risk Management Alerts and Advisories

Let the Risk Managers of The Neurologists' Program keep you up to date with the latest in professional liability news.

NEJM Publishes Article on Meaningful Use by National Coordinator for Health IT David Blumenthal
July 13, 2010: Today the New England Journal of Medicine published an article written by National Coordinator for Health IT David Blumenthal, MD, MPP and Principle Deputy Administrator of CMS Marilyn Tavenner, RN, MHA discussing the final rule governing Meaningful Use for 2011 and 2012. The article includes a summary list of the objectives and corresponding measures for acheiving meaningful use. To read the article, click here.

CMS Publishes New Website About EHRs and Meaningful Use
June 18, 2010: CMS today published a new website with information about Electronic Health Records and the Meaningful Use incentive program. The site includes information about eligibility requirements and certification of records systems, and will be updated with information about registering for the incentives, the definition of meaningful use, and training programs and other events as it becomes available. Visit the site at http://www.cms.gov/EHRIncentivePrograms

AAN Issues New Guideline for Determining Brain Death
June 6, 2010: For the first time in 15 years, the American Academy of Neurology has updated their guideline on determining brain death. New data has confirmed the accuracy of diagnoses made using the previous criteria, but the updated guideline published in the June 8 edition of the journal Neurology provides more tools, including step-by-step instructions for clinical evaluation, to help guide clinicians in their decision-making. For the PubMed entry for the new guideline, click here. To read the guideline in Neurology, click here.

FTC Delays Enforcement of Red Flags Rule until December 31, 2010
June 1, 2010: The FTC has again delayed the enforcement of the Reg Flags Rule to December 31, 2010. The AMA has also filed a lawsuit to block application of the Rule to physicians, and Congress has proposed an amendment to the law which would apply the Rule to healthcare practices, but only to those with 20 or more employees.

Despite the recent developments, it would be prudent for physicians to assume that the Rule will be enforced starting 12/31/2010. The AMA has resources related to the Red Flags Rule, including sample forms and policies, available here. To read the FTC press release about the most recent enforcement delay, click here.

FTC Delays Enforcement of Red Flag Rules to June 1, 2010
October 30, 2009: The FTC has delayed enforcement of the Red Flag Rules to June 1, 2010, and the AMA continues to advocate against application of the Rules to physicians. However, the safest approach for physicians is to assume that the Rules will be applied to their practices. To read the AMA press release, click here. For guidance documents from the FTC, click here.

CMS Publishes HIPAA FAQ Sheet for Providers
September, 2009: CMS has published a Providers' Privacy Guide to address some questions frequently asked by providers about the impact of HIPAA's Privacy Rule. Topics addressed include communicating with other providers, communicating with family members, and reporting child abuse. However, providers should also remember that HIPAA is a floor of privacy protections, and state law may be more restrictive on sharing information. To access the guide, click here.

Joint Commission Issues Sentinel Event Alert About the Importance of Leadership's Role in Patient Safety
August 27, 2009: Today the Joint Commission issued a Sentinel Event Alert discussing the importance of an organization's leadership playing an active role in the promotion of patient safety. The Alert provides 14 (fourteen) suggested actions for senior leadership to take to more fully promote and support a culture of safety within their organization. To read the Alert, click here.

FTC Delays Enforcement of Red Flag Rules until November 1, 2009, Issues a Frequently Asked Questions List
July 29, 2009: The FTC today announced that it has moved the deadline for compliance with the Red Flag Rules back from August 1, 2009 to November 1, 2009. FTC has also published a list of Frequently Asked Questions about interpreting and complying with the regulations. For more information, click here.

CMS (Centers for Medicare and Medicaid Services) has issued a SCAM ALERT NOTICE warning
June 18, 2009: CMS has issued a SCAM ALERT NOTICE warning of perpetrators posing as Medicare Contractors or Carriers faxing providers a questionnaire to provide account information. The fax may have the CMS logo and/or the contractor logo. CMS advises providers to check with the carrier / contractor before submitting any information. To view the Scam Alert Notice, click here.

AAN Issues Updated Guidelines, Patient and Clinician Summaries for Treatment of Pregnant Women with Epilepsy
Apr 27, 2009: The American Academy of Neurology has published updated Practice Parameters, along with summary documents for patients and clinicians, regarding the treatment of women with epilepsy, with a focus on pregnancy-related issues. The guidelines address a range of issues, including breastfeeding, OB complications, and teratogenesis. To read a discussion about the new guidelines with Dr. Cynthia Harden (the lead author of these guidelines), and to access the guidelines and summaries, click here.

UPDATE - FTC Delays Enforcement of Red Flag Rules Until August 1, 2009
Apr 30, 2009: The Federal Trade Commission today announced it will delay the compliance date for the new Red Flag Rules until August 1, 2009. This three-month extension is intended to give businesses covered by the rules more time to develop their identity theft detection programs. To read the FTC's press release, click here.

American Medical Association Posts Red Flag Rules Compliance Resources, Including a
Sample Policy
Apr., 2009: The American Medical Association has posted resources for physicians related to the Red Flag Rules issued by the Federal Trade Commission (FTC). Physicians who are covered by the rule are required to comply by May 1, 2009. The resources include a guidance document addressing some frequently asked questions as well as a sample Red Flag Rules policy document that physicians can customize to fit their individual practice. To access the AMA Resources, click here.

Joint Commission Issues Sentinel Event Alert about Preventing Technology-Related Healthcare Errors
Dec. 11, 2008: The Joint Commission today issued a Sentinel Event Alert about safely implementing Health Information Technology (HIT) systems. The alert warns that using HIT does not guarantee success or patient safety, and urges greater attention to the process of selecting, implementing, and maintaining an HIT system. To read the Alert, click here.

FDA Says Pharmacy-Provided Drug Information Not Consistently Clear or Useful
Dec. 16, 2008: The FDA today released the results of a study that found that Consumer Medication Information ("CMI") sheets provided by pharmacies to patients do not consistently provide clear, easy-to-read information about the risks and directions for use of medications. To read more about the study and CMI in general, click here.

FDA Announces It Will Require New Warnings On All Antiepileptic Drugs
Dec. 16, 2008: The FDA today announced that it has concluded a metastudy of suicidality associated with antiepileptic medications, and will require new warnings about an increased risk of suicidality on the labels of all such medications. In accordance with the recommendations made in July by their independent panel, FDA will not require black-box warnings. FDA recommends that all patients who are on antiepileptics for any indication "be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression." To learn more, visit FDA's webpage on antiepileptic medications by clicking here.

Nov. 25, 2008: In response to questions from schools and providers, as well as the "Report to the President on Issues Raised by the Virginia Tech Tragedy" (http://www.hhs.gov/vtreport.html), the Office for Civil Rights and the Department of Education today issued a joint guidance document regarding records created and information learned during treatment at a school facility, such as a Student Health Clinic or Student Counseling Center. The guidance addresses when records are covered by FERPA, when they are covered by HIPAA, and when information may be disclosed in either case. To read the guidance, click here.

Preliminary FDA Data Suggest Increased Risk of SJS and TEN for Asian Patients on Phenytoin or Fosphenytoin Sodium
November 24, 2008: The FDA today announced that it is investigating preliminary data about Phenytoin and Fosphenytoin Sodium that suggest an increased risk of serious skin reactions, including Stevens Johnson Syndrome and toxic epidermal necrolysis, in Asian patients who test positive for HLA-B* 1502. Until the investigation is completed, FDA recommends special attention to the risk/benefit profile discussed on the drug's label. For more information, click here.

Ethex Corp Recalls Generic Morphine Sulfate, Dextroamphetamine Sulfate, and Two Other Medications
November 10, 2008: Ethex Corp and the FDA notified healthcare providers of a recall of Propafenone HCL tablets, Isosorbide Mononitrate ER tablets, Morphine Sulfate ER tablets, Morphine Sulfate IR tablets, and Dextroamphetamine Sulfate tablets. These products may contain oversized tablets, and up to twice the expected dose of the active ingredient. For more information, view the FDA MedWatch post here.

Recall of Dextroamphetamine Sulfate tablets
October 16, 2008: Today, FDA and Ethex Corp announced a voluntary recall of three lots of Dextroamphetamine Sulfate 5mg tablets. Some tablets in these lots may contain as much as twice the labeled amount of the active ingredient, increasing the risk of side-effects. To read the MedWatch announcement, click here.

Industry Consortium Releases Guidelines for Preventing Hospital-Acquired Infections
October 8, 2008: Today a consortium of industry associations including the Joint Commission, American Hospital Association, Infectious Diseases Society of America, Society for Healthcare Epidemiology of America, and Association for Professionals in Infection Control released guidelines for preventing hospital-acquired infections ("HAIs"). Although previous guidelines have provided evidence-based recommendations for detecting and preventing HAIs, these new guidelines include practical recommendations designed to assist hospitals in implementing and prioritizing HAI prevention efforts. To download a copy of the guidelines and for more information, click here.

FDA Announces Results of Analysis of Statins and ALS
September 30, 2008: The FDA today announced that an analysis of 41 long-term controlled clinical trials revealed that the use of statins does not increase the incidence of ALS when compared with placebo. The FDA anticipates results from an epidemiological study of ALS and statin use within 6-9 months. To read the FDA's MedWatch announcement, click here

Joint Commission Issues Sentinal Alert About Blood Thinners
September 24, 2008: Today the Joint Commission issued a Sentinal Alert about blood thinners. The Alert notes that the US Pharmacopeia's MEDMARX database received over 59,000 reports of errors involving blood thinners between 2001 and 2006, with over 1,500 resulting in harm to the patient. To read the alert, click here.

OCR Issues Guidance on HIPAA Privacy Rule, Talking to Patient's Family Members
September 16, 2008: Today the Office for Civil Rights, the agency responsible for enforcing HIPAA, issued guidance for both patients and providers about when a provider may - under the federal Privacy Rule - communicate with a patient's family, friends, and other persons involved in care. The guidance for providers explains how the rule operates in several scenarios, and gives examples of things providers can and cannot do in those scenarios. To download a copy of the guidance document, click here. It is important to remember that this guidance only addresses the requirements of HIPAA. Your state's law, and your ethical obligations, may be more protective of patient information

HIPAA Enforcement By HHS
September 9, 2008: The two HHS agencies responsible for enforcement of HIPAA’s Privacy Rule and Security Rule have made detailed enforcement information available online. HHS’ Office for Civil Rights (OCR) has made Privacy Rule enforcement information available at http://www.hhs.gov/ocr/privacy/enforcement/ including the following:

HHS’ Center for Medicare and Medicaid Services (CMS) has made Security Rule enforcement information available at http://www.cms.hhs.gov/Enforcement/ including the following:

FDA Now Posts Quarterly Listings of Medications Being Investigated for Potential Problems
Sept 5, 2008: FDA today posted the first of what will be quarterly listings of medications being investigated for potential problems. The listings indicate that potential signals of serious risks have been identified for the medication using the Adverse Event Reporting System data, but do not indicate that the FDA believes the drug actually has the risk. Medications listed will be investigated further by the FDA to determine whether the signals identified correspond to any actual risk or not. FDA is required to post this list by law, and states that "the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication." Instead, the lists are intended to promote communication between patients and physicians about prescription drug safety. To view the list, click here. To read FDA's explanation of the list, click here.

Information Available About Adverse Events Involving Methodone
August, 2008: Information about serious adverse events and deaths involving methadone prescribed for chronic pain is becoming more widely available. Such events have been reported even when medication abuse is not present. It is essential that physicians who prescribe methadone and other opioids for pain management understand the risks associated with these medications. The US Substance Abuse and Mental Health Services Administration ("SAMHSA"), in conjunction with local medical boards, schools, hospitals and societies sponsors CME classes on prescribing opioids for pain management. For more information about these ACCME-accredited courses, click here.

Guidelines Issued for Use of Medication Samples
June 24, 2008: The National Coordinating Council for Medication Error Reporting and Prevention today issued guidelines for dispensing medication samples, designed to highlight risks involved with the use of samples and to help prevent errors. The guidelines are available on NCCMERP's website. Click here to view the guidelines.

Preventing Pediatric Medication Errors
April 11, 2008: The Joint Commission has issued a Sentinel Event Alert which includes specific strategies for reducing pediatric medication errors. Click here to view the Alert

CDC’s MMWR Report Addresses School-Associated Student Homicides
View January 18, 2008 Report

Final Rule - Multiple Prescriptions for Schedule II Drugs
11-7-07: The DEA has issued a final rule - "Issuance of Multiple Prescriptions for Schedule II Controlled Substances". The rule, codified at 21 CFR Part 1306, is effective December 19, 2007.

DEA regulations have been amended "to allow [under certain specified conditions] practitioners to provide individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90-day supply of that controlled substance". Click here to read the rule. [NOTE: The actual modifications to the rule appear at the very end of the document.]

HHS Issues Security Guidance on Use of Laptops and Other Portable Devices
CMS, the HHS agency responsible for enforcement of HIPAA's Security Rule, has issued a guidance document related to the security of laptops and other portable devices. The document provides specific strategies that CMS may consider reasonable and appropriate for offsite access to electronic protected health information (EPHI). View guidance document.

Final Rule Issued on Restraints and Seclusion
12-8-06: The Centers for Medicare and Medicaid Services published a final rule on patients' rights for facilities participating in the Medicare and Medicaid programs. Among other things, the rule:

HHS Releases Regulations Creating Exceptions to the Stark and Anti-Kickback Laws for Electronic Prescribing and Electronic Health Records Technology

Agency for Healthcare Research and Quality online patient safety resource and journal - Web M&M.
Agency for Healthcare Research and Quality is an online patient safety resource and journal -- Web M&M: http://www.webmm.ahrq.gov. The site features:

Joint Commission's Speak Up Campaign
The Speak Up Program to prevent medical errors develops patient brochure to prevent medication mistakes. View website.

Joint Commission's International Center for Patient Safety
This site provides numerous patient safety resources. The Joint Commission's International Center for Patient Safety's mission is "To continuously improve patient safety in all health care settings."

"The Joint Commission and Joint Commission Resources (JCR) established the Joint Commission International Center for Patient Safety in March 2005. The Center is a natural extension of the well-established patient safety activities for which the Joint Commission and JCR are recognized. The Center leverages the expertise, resources and knowledge from both the Joint Commission and JCR." View website.

FDA Warns of Serious or Even Fatal Skin Reactions
FDA warns of serious of even fatal skin reactions for some patients treated with medications containing carbamazepine.

"FDA informed healthcare professionals that dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B*1502 is present should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine."