This column provides executive summaries of developments in legal and regulatory issues related to healthcare, lists a bibliography of pertinent healthcare law-related articles, and discusses interesting health law court decisions.
CASES
Rodriguez v. 1201 Realty, LLC (781 N.Y.S.2d 328, Sup. Ct. NY 2004)
A hospital was potentially liable for the rowdy behavior of unattended children in its emergency room when one of the unattended children knocked over another child waiting to be seen, causing him to fracture his elbow.
Fort Worth Osteopathic Hospital, Inc. v. Reese (No. 02-1061, Tex. August 27, 2004)
The Texas Supreme Court has held that there is no equal protection guarantee for patents of a stillborn child to bring a wrongful death or survival action claims against their healthcare providers. Texas' wrongful death and survival statutes do not encompass an unborn fetus when the claim arises from a claim of medical malpractice.
Inglis v. Providence Hospital and Medical Centers, Inc. (No. 247066, Michigan Court of Appeal, August 26, 2004)
A hospital was not held liable for the action of a physician under a theory of ostensible agency even though the physician's office was in a hospital-owned medical office building and he used the hospital's consent forms because there was insufficient evidence that the patient (who had died following the surgery) had reasonably believed that the physician was the ostensible agent of the hospital.
Binkley v. Edward Hospital (No. 02 C 2508, 2004 WL 2211647, N.D. Ill. September 20, 2004)
A hospital in Illinois that discharged a mentally ill patient 19 days after he was admitted for an emergency medical condition could be liable for violating EMTALA because the patient alleged that he presented to the emergency room with an emergency medical condition and the hospital discharged him before he was stabilized.
Ashcroft v. State of Oregon (12 No. 9 Andrews Health Law Litigation Reporter 4, January 19, 2005)
The United States Attorney General has filed papers with the United States Supreme Court asking it to overturn a decision by the United States Court of Appeals for the 9th Circuit which held that the federal government has no right to interfere with Oregon's voter-approved Death with Dignity Act. The Supreme Court has agreed to review the matter, and arguments will be heard in the court's next term, which begins in October 2005. (High Court Agrees to Review Nation's Only Assisted Suicide Law, http://CNN.com, March 13, 2005).
Turner v. Legacy Health Systems (12 No. 9 Andrews Health Law Litigation Reporter 5, January 19, 2005)
Plaintiffs in proposed class actions in the Pacific Northwest alleging that a pair of hospital systems failed to fulfill their obligations to provide charitable care for uninsured patients have dropped their lawsuits. The suits alleged that the hospitals breached their duty to provide charity care to uninsured patients by charging them prices exceeding those charged to patients with insurance.
Kizzire v. Baptist Health System, Inc. (No. CV-04-HS-1247-S, 2004 WL 2473473, N.D. Ala. October 21, 2004)
The United States District Court for the Northern District of Alabama has dismissed a proposed class action lawsuit against Baptist Health System, Inc. for alleged violations of its charity care obligations as a tax-exempt entity. The court held that the claims were barred by the principle of res judicata, citing previous state court actions brought by the hospital to collect payment for medical services provided. The court reasoned that the patients should have asserted counterclaims in those suits that the charges imposed by the hospital were unreasonable.
DePaul v. St. Elizabeth Health Center (No. 03 MA 137, Ohio Ct. App. September 17, 2004)
The Ohio Court of Appeals has reversed a trial court decision holding that an incident report was discoverable in a medical negligence suit arising from a patient injury. The Court of Appeals held that Ohio Revised Codes Annotated Section 2305.253 makes it clear that incident reports are not subject to discovery regardless of whether any other statute has an exception. This section provides an absolute privilege for incident reports and the trial court erred in holding that this report was discoverable.
Furlong v. Catholic Healthcare West (12 No. 9 Andrews Health Law Litigation Reporter 10, January 19, 2005)
The son of a nursing home patient who had life-sustaining procedures performed on her despite a do-not-resuscitate order was not permitted to pursue an elder abuse claim against the physicians and nurses who resuscitated her.
In re Guardianship of Schiavo (12 No. 7 Andrews Health Law Litigation Reporter 13, November 17, 2004)
The Pinellas County Circuit Court ruled on October 22, 2004 that the parents of Terri Schiavo could not proceed with an evidentiary hearing on their assertion that their daughter would want to continue with life-sustaining measures because of her beliefs as a Catholic, thus holding that they cannot litigate their claim that removal of the feeding tube would violate the patient's Catholic beliefs.
In re Guardianship of Schiavo (12 No. 9 Andrews Health Law Litigation Reporter 12, January 19, 2005)
Florida's Second District Court of Appeal denied without comment a plea by the parents of Terri Schiavo that removal of her feeding tube would violate her Catholic beliefs.
Bush v. Schiavo (12 No. 10 Andrews Health Law Litigation Reporter 14, February 16, 2005)
In another action in the Schiavo matter, the United States Supreme Court declined to review a decision by the Florida Supreme Court striking down as unconstitutional a law authorizing state Governor Jeb Bush to order reinsertion of a feeding tube.
Florida Judge Upholds Removal of Tube
At press time, the presiding judge in Florida's legal skirmish over Terri Schiavo ruled that her feeding tube must be removed on March 18, 2005, despite the issuance of congressional subpoenas for Ms. Schiavo and her husband to appear before congress later in the month. Fox News (March 18, 2005).
Bryant v. Oakpointe Villa Nursing Center (Nos. 121723 & 121724, 204 WL 1724901, Michigan, July 30, 2004)
In a Michigan case, that state's Supreme Court has held that claims against a nursing home for failing to inspect a patient's bed arrangement and failing to train its staff on assessing the risk of potential asphyxia were claims sounding in medical negligence and not ordinary negligence, but that plaintiff's claim that the home failed to take steps to protect the patient after finding her entangled in her bedding on the day before her death did sound in ordinary negligence, because the facility had notice of the risk of asphyxiation but did nothing to rectify the situation.
Connolly v. H.D. Goodall Hospital (10 No. 8 Andrews Healthcare Fraud Litigation Reporter 7, February 14, 2005)
A Maine nurse suspended from her job after publicly criticizing President Bush's healthcare policy has lost her federal civil rights suit for failing to establish a link between state law and her constitutional rights.
Judge OKs Discarded Embryo Lawsuit
In an Illinois case, a judge has ruled that a couple whose frozen embryo was accidentally destroyed at a fertility clinic has the right to file a wrongful-death lawsuit. The court's opinion stated that "a pre-embryo is a 'human being'[horizontal ellipsis]whether or not it is implanted in its mother's womb" and indicated that the couple is as entitled to compensation as any parents whose child has been killed. The ruling relied on the state's Wrongful Death Act, which allows suits to be filed if unborn fetuses are killed in an accident or an assault. (http://CNN.com, February 5, 2005).
Lawsuit in California Staffing Ratio Battle
The California Nurses Association has filed a lawsuit against the state in an effort to reverse recent changes in the state's nurse-to-patient staffing ratios. The case claims that the California Department of Health Services lacked authority to change the regulations and that the changes could harm patient care. According to the California Healthcare Association, the changes approved on November 12, 2004 would delay for 3 years a scheduled decrease in the minimum nurse-to-patient ratio for medical surgical units to a 1:5 ratio from 1:6 currently. The change is effective for 120 days while DHS pursues its normal rulemaking process. According to the CHA, the emergency regulation was issued because of real concerns that the nursing shortage was impacting hospitals' ability to implement the ratios, thus jeopardizing access to care. DHS believes the staffing ratios have been a factor in the closure of 9 hospitals and 2 hospital units. AHA News Now (December 22, 2004).
Planned Parenthood v. Heed (12 No. 8 Andrews Health Law Litigation Reporter 2, December 22, 2004)
A New Hampshire law requiring minors to obtain parental consent before having an abortion has been struck down by a ruling of the United States Court of Appeals for the First Circuit. The Federal court agreed with a lower court's ruling that the law was unconstitutional because it failed to protect the health of young women.
Darr v. Sutter Health (12 No. 8 Andrews Health Law Litigation Report 4, December 22, 2004)
A Federal judge in San Francisco has dismissed a proposed class action suit accusing one of the country's largest nonprofit healthcare systems of charging uninsured patients predatory and discriminatory prices.
In re Not-for-Profit Hospital/Uninsured Patients Litigation (12 No. 7 Andrews Health Law Litigation Reporter 2, November 17, 2004)
The United States Judicial Panel on Multidistrict Litigation has denied a motion to consolidate a group of federal lawsuits accusing nonprofit hospitals and hospital systems in 23 states of failing to fulfill their obligations to provide charitable care. The panel ruled that consolidation of the cases would not serve the convenience of the parties and witnesses nor would it further the just and efficient conduct of the litigation.
SETTLEMENTS/VERDICTS
U.S. v. Health South Corp. (10 No. 7 Andrews Healthcare Fraud Litigation Reporter 2, January 17, 2005)
Health South has settled a Medicare Fraud Case for US$325 million in which several whistle-blower suits alleged Medicare fraud as well as other healthcare billing improprieties.
In re Tenet Healthcare Cases III (10 No. 7 Andrews Healthcare Fraud Litigation Reporter 7, January 17, 2005)
Tenet has settled claims brought by former cardiac patients who claim that one of its California hospitals repeatedly performed unnecessary heart surgeries. The settlement of US$395 million will be allocated among more than 750 patients who had filed lawsuits against the corporation and its subsidiaries.
George H. Lanier Memorial Hospital v. Andrews (12 No. 8 Andrews Health Law Litigation Reporter 7, December 22, 2004)
A US$200,000 judgment against a hospital that allegedly harvested a deceased boy's corneas without his parents' permission has been upheld by the Alabama Supreme Court.
United States v. NYU Downtown Hospital (10 No. 4 Andrews Healthcare Fraud Litigation Reporter 2, October 11, 2004)
A New York University Hospital affiliate has settled a Medicaid billing fraud civil suit for US$2.1 million.
U.S. ex rel. Crowell v. Downey Community Hospital Foundation (10 No. 3 Andrews Healthcare Fraud Litigation Reporter 8, September 13, 2004)
Downey Regional Medical Center has settled for US$2.2 million false claims charges of billing Medicare for services the program does not reimburse.
LEGISLATION
A California Senate bill (AB 253) to enforce the nursing ratios in that state by providing for US$10,000 fines on hospitals that violate the law as well as US$5,000 fines for other patient safety violations died in conference on November 30, 2004.
In February 2005, the Georgia Senate passed an omnibus civil and medical malpractice legal reform bill, which has gone to the governor for signature, including a provision capping noneconomic damages at US$350,000. The bill's provisions regarding emergency room care provision would largely exempt hospitals from paying for medical damages associated with care given in an emergency situation. The bill also contains provisions regarding joint and several liability and settlement offers. Ramos, R. Tort Reform Bill Passes General Assembly, Heads to Purdue, Atlanta Business Chronicle (February 14, 2005).
A bill introduced in January 2005 in the United States House of Representatives would help give relief from an imminent change in immigration processing that threatens to make the nation's nursing shortage worse. The bill is meant to address the State Department's recent announcement that the government would no longer issue employment-based visas for workers in countries that have exceeded their annual quota for green cards. This includes countries such as the Philippines, India, and China. The bill, H.R. 139, would authorize the reassignment of unused visas for people from countries with unmet quotas to these other countries. Many Philippine nurses come to work in the United States, thus the impact on the nursing shortage. AHA News Now (January 4, 2004).
Minnesota has revised its adverse health reporting system, which was established in 2003. The changes include the following: the licensing boards that regulate physicians, physician assistants, nurses, pharmacists, and podiatrists are required to report to the Minnesota Department of Health events that come to their attention that may qualify as adverse healthcare events. Reported data submitted by facilities and the licensing boards to the Department of Health will be classified as nonpublic except as required by law. Events properly reported under this law are now exempt from the reporting requirements of the Maltreatment of Minors Act. Lastly, outpatient surgical centers are now required to report adverse events. More information is available at http://www.health.state.mn.us/patientsafety/legislation.html.
Ohio's state assembly passed a comprehensive tort reform bill on December 9, 2004, that includes a defense for manufacturers of FDA-approved drugs and devices, caps on damages, and other protections from frivolous lawsuits. The bill was expected to be signed by the governor. (10 No. 7 Andrews Healthcare Fraud Litigation Reporter 13, January 17, 2005).
REGULATIONS
The Centers for Medicare and Medicaid Services has published a rule to modernize the Medicare End-Stage Renal Disease conditions for coverage. The rule was published on February 4, 2005, and when final, will serve as the minimum quality standards applied during the Medicare survey and certification process. It reflects clinical practice guidelines developed by the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative. CMS News: Proposed Medicare Rule Would Modernize End-Stage Renal Disease Conditions for Coverage (January 30, 2005).
The Centers for Medicare and Medicaid Services has proposed new requirements that organ procurement organizations and organ transplant centers must meet in order to have their services covered by Medicare. These rules were published in the Federal Register on February 4, 2005. CMS News: Medicare Proposed Conditions of Participation for Transplant Centers and Organ Procurement Organizations (January 28, 2005).
The Centers for Medicare and Medicaid Services has issued a proposed rule that would increase the Medicare payment rates for long-term care hospitals by 3.1% for discharges on or after July 1, 2005 through June 30, 2006. This proposed rule was published in the February 3, 2005 Federal Register and will be published as a final rule later in the spring.
The Office of Inspector General has issued a Supplemental Compliance Program Guidance for Hospitals. This document contains new compliance recommendations and an expanded discussion of risk areas. It provides guidelines to assist hospitals and hospital systems in identifying significant risk areas and refining ongoing compliance efforts. The full text of the guidance can be obtained at http://oig.hhs.gov.
In October 2004, CMS Administrator Mark McClellan indicated that hospitals will not be required to ask for and report a patient's immigration status in order to receive funding for uncompensated emergency care provided to undocumented immigrants. CMS is expected to release formal guidance regarding this aspect of the Medicare Modernization Act's requirements. AONE E News (October 8, 2004).
JCAHO
Beginning in July 2005, JCAHO will require hospitals to measure the number of eligible organ donors who actually donate organs. Hospitals will also be required, where possible, to take steps to improve this number. AHA News Now (January 5, 2005).
JCAHO has modified its 2005 requirements for standardizing medical abbreviations and symbols to apply to preprinted forms consisting of orders and medication related documents as well as handwritten documentation. AHA News Now (January 5, 2005).
JCAHO has announced a new campaign, Speak Up-Things You Can Do to Prevent Medication Mistakes, which provides information about preventing medication mistakes as well as questions the patient can ask providers. All materials for this campaign are available at http://www.jcaho.org/accredited+organizations/speak+up/speak+up+initiatives.htm.
JCAHO has issued an alert regarding prevention of errors involving patient-controlled analgesia. The alert recommends that healthcare providers develop criteria for selecting appropriate PCA patients, teach patients and family members about the proper use of PCA, and alert staff to the dangers of administering a PCA dose outside of a nurse-controlled protocol. AHA News Now (December 21, 2004).
JCAHO has launched a certification program for healthcare staffing firms. For information about this program, visit the organization's Web site at http://www.jcaho.org.
JCAHO has issued a sentinel event alert regarding anesthesia awareness, the full text of which is available at http://www.jcaho.org.
JCAHO and CMS have released common national hospital performance measures in the areas of acute myocardial infarction, heart failure, pneumonia, and surgical infection prevention. These measures, contained in the Specifications Manual for National Hospital Quality Measures, version 1.0, became effective with January 2005 hospital discharges, and can be accessed at both organizations' Web sites.
This year, JCAHO will be requiring hospitals to select at least 10 look- and sound-alike drug name pairs, and to initiate effective safety strategies to prevent accidental mixing up of these drugs. At least 5 of the name pairs must be selected from a hospital-specific list. The remaining name pairs may be selected from a supplementary list or from lists applicable to other healthcare settings. More information about this requirement is available at http://www.jcaho.org.
NEWS
The Food and Drug Administration has cleared for marketing an external surgical marker tag intended to minimize the likelihood of wrong-site, wrong-procedure, and wrong-patient surgeries. The device, called the SurgiChip Tag Surgical Marker, is manufactured by SurgiChip, Inc., of Palm Beach Gardens, Fla. FDA Talk Paper: FDA Clears New Surgical Marker; Uses RFID to Protect Patients (November 19, 2004).
In November 2004, the Kansas Hospital Association Board of Directors approved a position statement opposing the use of nurse/patient ratios. The statement indicates that the process of determining hospital staffing is best determined at a local level. AONE E-News (November 26, 2004).
A study published in the November 2004 issue of Applied Nursing Research showed that a number of errors and near-errors by hospital staff nurses were related to procedural, transcriptions, and charting issues rather than being medication related. Researchers suggest the results indicate that an exclusive focus on medication administration errors may miss many important and potentially hazardous situations. AONE Voice of Nursing Leadership (January 2005:13).
A multicenter study supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health shows that the pulmonary artery catheter does not significantly increase or decrease deaths or the number of days hospitalized in patients with severe heart failure. These findings help resolve previous controversy as to the risks and benefits of this device. NIH Press Release: No Increase in Deaths or Hospitalizations for Heart Failure Patients Who Have a Pulmonary Artery Catheter (November 9, 2004).
The National Quality Forum has published a new set of national standards for nursing care, which provide a framework for how to measure the quality of nursing care, and can be used by consumers to assess the quality of nursing care in hospitals and by providers to identify areas for improvement of critical outcomes and processes of care. The report, entitled National Voluntary Consensus Standards for Nursing-Sensitive Care: An Initial Performance Measure Set, can be accessed at http://www.qualityforum.org. NQF has also announced 21 voluntary quality measures for cardiac surgery, also available at the organization's Web site.
The Leapfrog Group has released the results of their Quality and Safety Survey, a national rating system that offers what is said to be the most complete assessment available of a hospital's quality and safety. The Survey covers over 1,000 hospitals, and data are updated monthly. The survey can be viewed at http://www.leapfroggroup.org, free of charge.
According to a study published in Health Affairs, there has been some progress in promoting patient safety and reducing medical errors since the Institute of Medicine's landmark 199 report "To Err is Human." However, progress has been slow because there has not been sufficient regulation of medical errors and there needs to be greater use of available information technology. This study indicates that the reasons behind the 88,000 deaths each year due to medical errors include a flawed model of accountability, collective inattention, a medical reimbursement system that pays healthcare providers regardless of whether they provide safe healthcare, and the concept that safety can be sacrificed for medical progress. The report, entitled "The End of the Beginning: Patient Safety Five Years After 'To Err is Human'," is available online at http://www.content.healthaffaris.org/cgi/content/abstract/hlthaff.w4.534.
A National Institutes of Health Panel has issued a state of the science statement on end of life care outlining several recommendations to advance research and improve care. The full text of the statement can be accessed at http://consensus.nih.gov.
A nurse at Los Angeles' county-run King Drew Medical Center turned down a monitor attached to a 28-year-old AIDS patient and failed to notice his heart was barely beating just before he died. A physician in training noticed the monitor screen flashing but was unable to resuscitate the patient. An investigation by the hospital revealed that the nurse also falsified the patient's medical chart by recording his vital signs as stable after he was actually dead. The nurse, who only had one other patient to care for at the time, was suspended. Three patients at this hospital died in 2003 when monitoring equipment either failed or was not properly monitored. More Trouble for King Drew Medical Center, Los Angeles Times (October 12, 2004).
A report released on November 1, 2004 by the Institute of Medicine found that shortcomings in the quality of healthcare provided in rural areas stem from a lack of access to core healthcare services including: primary care in the community, emergency medical services, hospital care, long-term care, mental health and substance abuse services, oral healthcare, and public health services. The report entitled, "Quality Through Collaboration: The Future of Rural Health," can be viewed online at http://www.iom.edu/report.asp?id=23359.
A study by the United States Pharmacopeia reports that nearly 20% of hospital and health system medication errors reported to its MEDMARX program in 2003 involved computerization or automation. Such errors were found to be the fourth leading cause of medication errors. However, facilities that have implemented computerized prescriber order entry (CPOE) reported fewer harmful errors. According to these data, automated dispensing devices were implicated in almost 9,000 medication error events with 1.3% of those errors leading to patient harm. AONE E-News Update (December 23, 2004).
As of December 15, 2004, the Washington State Hospital Association has asked all state hospitals to disclose to families or close friends the location and condition of patients who are unable to tell the hospital whether they want their information released. This action results from a series of experiences by families in that state where hospitals refused to provide information to families whose loved ones had been admitted and were incapacitated. Under this policy, health providers would not disclose information if they believed refusing to do so was in the patient's best interest (ie, in the case of domestic violence). Hospitals would also continue to follow state laws prohibiting disclosure of information about certain patients such as those admitted for mental health treatment or into federally assisted substance abuse treatment. Ostrum, C. Hospital Group Backs Disclosure, Seattle Times (Wednesday, December 15, 2004).
The Institute for Healthcare Improvement has launched the 100,000 Lives Campaign, to disseminate tools to implement changes in care that have been proven to prevent avoidable deaths. Information on this program is available at http://www://ihi.org/programs/campaign.
An advisory opinion by the Department of Health and Human Services' Office of Inspector General indicates that a medical center's proposal to temporarily subsidize the medical malpractice insurance premiums of 4 community-based obstetricians that provide services in a healthcare shortage area would not prompt the imposition of administrative sanctions under the Anti-Kickback Statute. Advisory Opinion No. 04-11 DHHS OIG (September 2, 2004).
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