Two Penn Center Plaza Suite 910 Philadelphia, PA 19102 215.569.0000 • One Oxford Centre Suite 4300 Pittsburgh, PA 15219 412.255.3767 • Sentry Office Plaza Suite 602 216 Haddon Ave. Westmont, NJ 08108 856.858.9499 Disclaimer		SUMMARY OF THE MEDICAL CARE AVAILABILITY AND REDUCTION OF ERROR (Mcare) ACT AND ITS IMPACT ON DAY-TO-DAY PRACTICE 1. Preservation and Accuracy of Medical Records (Section 511) Entries in Patient Charts Entries in patient charts concerning care rendered must be made contemporaneously or "as soon as practicable." Comments There is no definition of "as soon as practicable." This will be established by evolving case law and regulation. Corrections of Medical Records Erroneously entered information. Where information has been entered erroneously or where it is necessary to clarify entries made on a patient's chart, healthcare providers may do so provided that: The corrections or additions are clearly identified as subsequent entries by a date and time. Comments It is good practice to record not only the date and time of the entry, but also explain why the entry is being written in order to clarify a previous entry. Adding Information to a Patient's Chart A healthcare provider may add information to a patient's chart where it was not available at the time the record was first created provided that: The additions are clearly dated as subsequent entries and they are made within a reasonable time. Comments "Reasonable time" is not defined but will be developed by case law and regulation. However, it is strongly suggested that the person making the entry explain the reason why the information was not available at the time the record was first created. Sanctions A healthcare provider who is aware of alteration or destruction in violation of Section 511 must report any party suspected of such conduct to the appropriate licensing board. Alteration or destruction of medical records for the purpose of eliminating information that would give rise to a medical professional liability action is a ground for license suspension. Violation of any portion of Section 511 is considered unprofessional conduct and a violation of the applicable licensing statute subjecting a physician to discipline and/or license revocation. Effective Date Section 511 is effective May 20, 2002. 2. Informed Consent (Section 504) The statute continues existing law that except in emergencies, a physician owes a duty to a patient to obtain informed consent of the patient or the patient's authorized representative prior to: Performing surgery, including the administration of anesthesia. Administering radiation or chemotherapy. Administering a blood transfusion. Inserting a surgical device or appliance. Administering an experimental medication, using an experimental device or using an approved medical device in an experimental manner. Consent is informed if the patient has been given: A description of the procedure. The risks and alternatives that a reasonably prudent person would require to make an informed decision as to that procedure. The standard requires a physician to warn of those risks and alternatives that a physician would provide acting in accordance with the accepted medical standards. Comments The surgeon should list the risks and alternatives on the chart and in detail. The consent should be witnessed and signed. 3. Informed Consent Now Includes "Knowing Misrepresentation" A physician may be held liable for failure to seek a patient's informed consent if the physician knowingly misrepresents to the patient his or her professional credentials, training or experience. Comments This statutory provision is new and by enacting this section the General Assembly overruled the case of Duttry v. Patterson. It has the potential to create significant additional liability for physicians. At a recent trial lawyers seminar on the Mcare Act, panel members were instructing attendees to demand production of website copy, pamphlets and brochures of physicians in order to match their experience in connection with certain surgical procedures with their representations in this printed material. It is easy to foresee plaintiff's lawyers arguing that representations as to "skill and competence" in surgery is a "knowing misrepresentation" if the surgeon has performed relatively few of the specified procedures. We anticipate that this will be an expanding area of liability for physicians over the next decade as plaintiff's lawyers continue to push the boundaries of "knowing misrepresentations." Evidence put before a jury in an effort to prove "knowing" misrepresentation will emotionally charge juries and result in punishing awards. It is crucial that surgeons immediately review all printed material available to patients on websites, pamphlets and handouts, and evaluate this material in the context of this broadened exposure and potential liability. Effective Date Section 504, with the exception of that portion overruling Duttry, is effective immediately and applies to pending cases. That subsection which overrules Duttry applies only to causes of action which arise on or after March 20, 2002, e.g., you are at risk now! 4. Reporting of Medical Professional Liability Action Filed Against Physician (Section 903) Under the Mcare Act a physician must report notice of a complaint filed against the physician to the appropriate state licensing board (medicine or osteopathy) within sixty days of the physician's receipt of the complaint. The physician must provide the docket number of the case, where the case is filed and a description of the allegations in the complaint. Other mandatory reporting to the licensing board include: Reporting regarding disciplinary actions against the physician; Information regarding sentencing for certain offenses under the Medical Practice Act or Osteopathic Medical Practice Act; The arrest of a physician for criminal homicide, aggravated assault, sexual offenses; or Violations of the Controlled Substance, Drug, Device and Cosmetic Act. Once a physician provides notice of a complaint he has received, the licensing board must: Conduct an investigation of a physician based on the complaint within four years. Comments The criteria and standards for review based on frequency and severity of complaints filed against a physician are to be developed by each licensing board; If an investigation has not already been initiated after receipt from a physician of the notice of the complaint (see above), the licensing board must commence an investigation no more than four years from the date the licensing board receives; Notice of a payment on behalf of the physician has been reported to the National Practitioner Data Bank; Notice that a payment in a medical professional liability action against the physician has been reported to the licensor board by an insurer; or Notice of a report made to the board regarding disciplinary action. Comments Physicians will be required to respond to investigations undertaken by their licensing boards which will be initiated based upon frequency and severity of complaints filed against a physician. It is well known that certain sub-specialities such as orthopedics, neurosurgery and OB/GYN result in a significantly higher number of legal actions than those against other general practitioners and specialists. Unless the licensing board develops criteria to take this reality into consideration, these sub-specialities are going to be singled out for an increasing number of investigations for which a physician will most certainly want to retain counsel. To date, that information reported to the National Practitioner Data Bank has been confidential. Now, reports of payments to the National Practitioner Data Bank must be sent to the licensing board. Upon receipt of notice of such a payment in a professional liability case an investigation must be commenced by the licensing board no more than four years from the date of notice. The likely result will be increased reluctance by physicians to give consent to settlements, resulting in more trials and an ever increasing drain of time from physician's practices. However the statute requires waiver of consent to settle unless the physician pays an additional premium for that right. Sanctions If the licensing board, after completing its investigation, determines that the physician has practiced negligently the licensing board may impose disciplinary sanctions or corrective measures. Comments Because of financial limitations upon the resources of licensing boards, it is likely that the finding of negligence against a physician by a jury will carry significant weight with the licensing board in evaluating whether "the physician has practiced negligently." (Section 905) Applicability and Effective Date Commencement of investigations of physicians by licensing boards applies to actions against a physician initiated on or after March 20, 2002. Comments In order to be in compliance with the statute you must promptly forward to your licensing board any complaint received in connection with a claim of medical professional liability. 5. Continuing Medical Education (Section 910) Beginning with the licensing period January 1, 2003, individuals licensed to practice medicine and surgery without restriction are required to enroll and complete 100 hours of mandatory continuing medical education during each two year licensor period. As part of the 100 hour requirement the licensing board will establish a minimum number of hours that must be completed in improving patient safety and risk management. In order to ensure attendance, random audits of reported credit hours are to be conducted, as a result of which official documentation proving attendance must be produced to the licensing board. Sanctions Non-compliance with this section may result in disciplinary proceedings. Effective Date The 100 hour requirement is effective January 1, 2003. 6. Changes in Percentage of Medical Practice in New Jersey v. Pennsylvania And Its Impact On Required Malpractice Insurance In Pennsylvania (Section 711) After 2002, total coverage (Basic coverage - first level of mandatory coverage) and the Mcare Fund (formally CAT Fund) is reduced from $1,200,000 to $1,000,000 per occurrence which will include varying components of primary and Mcare coverage. Basic Coverage Basic coverage limits (first level of mandatory coverage) for policies issued or renewed in the calendar year 2002 is $500,000 per occurrence or claim and $1,500,000 per annual aggregate (all claims in a policy year) for a healthcare provider who conducts more than 50% of his business or practice within the Commonwealth. For policies issued or renewed in the calendar years 2003, 2004 and 2005: Basic insurance coverage for a healthcare provider who conducts more than 20% of his healthcare business or practice within the Commonwealth is required to have the limits set forth above. A healthcare provider who conducts 20% or less of his healthcare business or practice within the Commonwealth is required to have insurance providing coverage of $1,000,000 per occurrence or claim and $3,000,000 per annual aggregate. For policies issued or renewed in calendar year 2006: A healthcare provider conducting more than 20% of healthcare business or practice within the Commonwealth of Pennsylvania is required to have $750,000 per occurrence or claim and $2,250,000 per annual aggregate. For a healthcare provider conducting 20% or less of his healthcare business in the Commonwealth of Pennsylvania the required insurance remains $1,000,000 per occurrence or claim and $3,000,000 per annual aggregate. Any healthcare provider who conducts more than 20% of his healthcare business or practice within the Commonwealth of Pennsylvania is now required to participate in the Medical Care and Reduction of Error (Mcare) Fund (the successor to the CAT Fund). Each healthcare provider is required to submit proof of insurance or self insurance to the insurance department within 60 days of the policy being issued. Mcare Fund Excess Coverage (Former CAT Fund Coverage) The excess coverage for 2002 will continue to be $700,000 for each occurrence and $2,100,000 per annual aggregate (all claims in a policy year). In 2003 to 2005 the new Mcare Fund coverage will be $500,000 per occurrence and $1,500,000 per annual aggregate (all claims in a policy year). In 2006 the Mcare coverage will be reduced to $250,000. Comments There are no guidelines to define the percentage of one's healthcare business or practice. Is it based upon revenue received, revenue accrued, professional time expended, etc.? It will now be virtually impossible to avoid Pennsylvania's basic and Fund coverages by "moving" a portion of one's practice to New Jersey. Sanctions Failure to submit proof of insurance or self-insurance will result in suspension or revocation of the healthcare provider's license. Effective Date See above discussion. 7. Mcare Fund Surcharges for Claims (Section 712(g)) An Mcare Fund surcharge of not more than 20% will be based upon: The prevailing primary premium (the schedule of occurrence rates approved by the commissioner for the Joint Underwriting Association) of a participating healthcare provider; The frequency of claims paid by the Mcare Fund on behalf of the healthcare provider during the past five most recent claim periods; If three or more claims have been paid during the prior five most recent claim periods, a 10% increase in the prevailing primary premium must be charged; If four or more claims have been paid during the past five most recent claim periods by the Mcare fund, a 20% increase in the prevailing primary premium must be charged. Even if no increase has been made pursuant to the above, an adjustment of up to 20% may be made in the prevailing primary premium of a healthcare provider based upon the severity of at least two claims paid by the fund on behalf of the healthcare provider during the five most recent claims periods. 8. Patient Safety Authority (Section 303) Required to annually gather statistical data regarding "incidents" and "serious events" for the purpose of making recommendations to the Department of Health regarding changes in healthcare practices and procedures for the purpose of reducing the number and severity of serious events and incidents. An "incident" is an event, occurrence or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient. The term does not include a serious event. A "serious event" is an event, occurrence or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient. The term does not include an incident. In order to carry out the authority's responsibilities, each medical facility (an ambulatory surgical facility, birth center or hospital) must develop a Patient Safety Plan and submit it for approval to the Department of Health. The Patient Safety Plan requires the medical facility to: Designate a patient safety officer; Establish a patient safety committee; Establish a system for healthcare workers (anyone from the janitor to the president of the hospital) to report "serious events" and "incidents;" Prohibit any retaliatory action against a healthcare worker for reporting a "serious event" or "incident;" Provide written notification to patients of a "serious event." A "serious event" must be reported by a medical facility to the Department of Health within 24 hours of the medical facility's confirmation of the occurrence of the "serious event." A healthcare worker (includes a physician, nurse and perhaps even a janitor) who reasonably believes that a "serious event" or "incident" has occurred must: Report the "serious event" or "incident" according to the Patient Safety Plan to the medical facility. The report must be made immediately or as soon thereafter as reasonably practicable but in no event later than 24 hours after the occurrence or discovery of a "serious event" or "incident." If a medical facility discovers that a healthcare provider, including a physician or nurse in the medical facility, during a "serious event" failed to report the event, the medical facility must notify the healthcare provider's (e.g., physician or nurse) licensing board of the failure to report. The medical facility must provide written notification to a patient affected by a "serious event" within seven days of the occurrence or discovery of the "serious event." Applicability and Effective Dates The duty imposed upon a healthcare worker to report a "serious event" or "incident," and the duty to notify patients of "serious events," commences on May 20, 2002. 9. Additional Civil Penalties for Violation of Mcare and Other Statutes (Section 908) In addition to other civil remedies or criminal penalties provided for in the Mcare Act, the Medical Malpractice Act of 1985, and the Osteopathic Medical Practice Act, the respective licensing boards by vote of a majority of the maximum number of the authorized memberships of each board may levy a civil penalty of up to $10,000 on any physician who violates any provision of the Act, the Medical Practice Act of 1985, or the Osteopathic Medical Practice Act. The penalty may be levied only after affording the accused party the opportunity for a hearing. 10. Consent to Settle Physicians no longer have the right to consent to a settlement of basic insurance coverage in connection with a medical professional liability insurance policy unless they make payment of an additional premium. Comments There are no guidelines with respect to the amount of this additional premium. It is suspected that this will be determined by the underwriters of each insurance company. BACK TO INDEX
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