Filing 37681698 E-Filed 02/11/2016 09:30:00 AM IN THE CIRCUIT COURT OF THE NINETEENTH JUDICIAL CIRCUIT IN AND FOR ST LUCIE COUNTY, FLORIDA CASE NO.: DIVISION: JOHN AUSTGEN, Plaintiffs, v. ABDUL SHADANI, M.D., LAWNWOOD MEDICAL CENTER, INC. d/b/a LAWNWOOD REGIONAL MEDICAL CENTER HEART INSTITUTE, HCA HOLDINGS, IN C., a Foreign Corporation, and HCA, INC., a foreign corporation, Defendants. COMPLAINT COME NOW the Plaintiff, JOHN AUSTGEN, and sues the Defendants, ABDUL SHADANI, M.D., (hereinafter ?Defendant LAWNWOOD MEDICAL CENTER, INC. d/b/a LAWNWOOD REGIONAL MEDICAL CENTER HEART INSTITUTE, (hereinafter ?Defendant HCA HOLDINGS, INC., a Foreign Corporation, and HCA, INC. a Foreign Corporation, (hereinafter collectively referred to as and alleges: PROCEDURE 1. This is an action for medical negligence pursuant to Chapter 766, Florida Statutes, and Florida Rule of Civil Procedure 1.650 for damages exceeding Fifteen Thousand Dollars exclusive of costs and interest. 2. In that regard, Plaintiff has complied with all necessary precedent conditions prior to ?ling this action pursuant to Florida Statutes 766. Defendants and those bearing a legal relationship with Defendants were provided with written Notice of Claim via certi?ed mail pursuant to Florida Statute 766.106 and Florida Rule of Civil Procedure 1.650. A good faith pre-suit investigation was conducted, and there is good faith belief that grounds exists for an action against Defendants. THE PARTIES 3. At all times material hereto, Plaintiff, JOHN AUSTGEN, was a resident of St. Lucie County, Florida. 4. At all times material hereto, Defendant, ABDUL SHADANI, M.D., was a physician practicing in St. Lucie County, Florida, holding himself out to the public including the Plaintiff, as a specialist in cardiology. 5. At all times material hereto, Defendant, LAWNWOOD MEDICAL CENTER, INC. d/b/a LAWNWOOD REGIONAL MEDICAL CENTER HEART INSTITUTE was a foreign corporation doing business in St. Lucie County, Florida, as LAWNWOOD REGIONAL MEDICAL CENTER HEART INSTITUTE. 6. At all times material hereto, Defendant, HCA INC., was a foreign corporation f/k/a HCA-THE HEALTHCARE COMPANY doing business in St. Lucie County, Florida, as LAWNWOOD REGIONAL MEDICAL CENTER HEART INSTITUTE. 7. At all times material hereto, Defendant, HCA HOLDINGS, INC., was a Foreign Corporation doing business in Florida in St. Lucie County as LAWNWOOD REGIONAL MEDICAL CENTER HEART INSTITUTE. 8. At all times material hereto, Defendants, LAWNWOOD, HCA INC., and HCA HOLDINGS were in the business of operating for pro?t hospitals and providing comprehensive healthcare to the public and the Plaintiff, JOHN AUSTGEN. 9. At all times material hereto, Defendants, LAWNWOOD, HCA INC., and HCA HOLDINGS operated a for-pro?t hospital, LAWNWOOD REGIONAL MEDICAL CENTER HEART INSTITUTE, in Fort Pierce, St. Lucie County, Florida. 10. At all times material hereto, Defendants LAWNWOOD, HCA INC., and HCA HOLDINGS are vicariously responsible for the actions of their doctors, nurses, agents, apparent agents, servants, and employees acting within the course and scope of their agency, apparent agency, servitude and employment at their hospitals and medical centers including Lawnwood. 11. At all times material hereto, Defendants, LAWNWOOD, HCA INC., and HCA HOLDINGS had a duty to assure comprehensive risk management and the competence of those doctors practicing at LAWNWOOD through careful selection and review pursuant to Florida Statutes 12. At all times material hereto, Defendants, LAWNWOOD, HCA INC., and HCA HOLDINGS are vicariously responsible for the actions of its doctors, nurses, agents, apparent agents, administrators, directors and employees for failing to ensure that LAWNWOOD had a comprehensive risk management program and failing to ensure the competence of its physicians and medical staff practicing at LAWNWOOD through care?il selection and review pursuant to Florida Statute ?766.l 10(1). CONDITIONS PRECEDENT 13. Plaintiff, JOHN AUSTGEN, has satis?ed all of the conditions precedent required by Florida law before ?ling this Complaint. BACKGROUND l4. Defendants, LAWNWOOD, HCA INC., AND HCA HOLDINGS have a long history of committing fraud. In June 2003, HCA paid the federal government $250 million as a result of a government investigation into Medicare cost report and home of?ce cost statement fraud. One month later, in July 2003, HCA paid another $641 million for fraud claims. This included a $5 million dollar payment on behalf of LAWNWOOD for submitting false claims to Medicare by in?ating entitlement to funds to treat indigent patients. 15. As a result of the fraud occurring in its hospitals and as part of its settlement of the fraud claims, HCA entered into a Corporate Integrity Agreement with the Of?ce of the Inspector General of the United States Department of Health and Human Services. The CIA required HCA and its subsidiaries, including LAWNWOOD, to maintain a written Code of Conduct and mandated that all employees and staff members be trained on policies and procedures. A copy of the Corporate Integrity Agreement is attached as Exhibit 16. According to code of conduct in effect at all times material hereto, mission is ?to provide high quality, cost effective healthcare to all of our patients.? HCA claims in it Code of Conduct that it ?aspires to a standard of excellence for all caregivers within its facilities, including the entire facility team, which is committed to the delivery of safe, effective, ef?cient, compassionate and satisfying care and services.? HCA mandates in its Code of Conduct that all patients are to be treated with warmth, respect and dignity and provided with care that is both necessary and appropriate. See attached Exhibit at 8. HCA is required by its Code of Conduct to have a comprehensive program ?to promote the quality objectives of the organization.? (Exhibit at 8). 17. In order to achieve its quality objectives, HCA hospitals, including LAWNWOOD, were required at all times material hereto to have a comprehensive and effective approach to handling the credentialing and privileging of members of the medical staff and the creation of effective peer review mechanisms within the medical staff (Exhibit at 8). 18. Between August 2007 and June 2008, Charles Tomlinson, a nurse at LAWNWOOD, witnessed the performance of several questionable medical procedures in the oath lab at LAWNWOOD. In or around late May or early June 2008, Tomlinson observed Defendant SHADANI insert a stent, a small expandable metal scalpel placed in an artery to improve the blood ?ow, in an 80-plus year old patient, whom Tomlinson thought had no more than 10 percent arterial blockage. Cardiologists do not operate on any blockage less than 70 percent. Just prior to the insertion of the stent, Tomlinson, as part of the cath team, witnessed the real-time ?uoroscopy image of the patient?s arterial structures. He recalled asking Defendant SHADANI: ?Sir, what are you going to SHADANI replied: ?Can you not see that 90 percent blockage?? Nurse Tomlinson?s response was simply: ?I?m sorry Sir, I don?t see it.? Nonetheless, SHADANI performed the procedure on the patient. 19. The next day, Nurse Tomlinson reported what happened in the oath lab to Bill Tatem, Director of the LAWNWOOD cath lab. Nurse Tomlinson asked Tatem: ?did you look at the ?lm of Tatem said reviewed it.? Nurse Tomlinson then asked Tatem if he was going to do anything about it. Tatem replied that he was not. Nurse Tomlinson said something to the effect of ?you could be causing further disease in this ,9 patien. Nurse Tomlinson asked Tatem if he was going to report the incident to his superiors, to which Tatem replied ?no Tomlinson, I like my job. I have bills to pay. I am not saying anything.? Tatem also added ?Tomlinson, if you feel strongly and pursue this, there may be repercussions.? Nurse Tomlinson understood that response to mean that he could be terminated. 20. About a week later, Nurse Tomlinson reported the incident to Pam Burcell, Ethics Of?cer and Human Resources Director. Nurse Tomlinson told her that there had been more than one questionable incident with SHADANI. Burcell did not ask very many questions, but she did ask if Nurse Tomlinson had talked to Tatem about the matter. Nurse Tomlinson explained that he had but that Tatem had refused to take any action. 21. Shortly after reporting his concerns to Tatem and Burcell, Tomlinson was told that his contract would not be renewed. 22. In July 2010, Tomlinson returned to work as a traveling nurse in the oath lab of another HCA hospital, St. Lucie Medical Center. "In August 2010, Nurse Tomlinson, due to fear of further retaliation, anonymously mailed identical letters to Richard Bracken, President and CEO of HCA, and Allan Yuspeh, Vice President and Ethics Of?cer of HCA. In the letters, Nurse Tomlinson expressed his concerns and provided several examples about wrongdoings impacting published Code of Conduct that he observed while working at HCA over a period of three years, including LAWNWOOD. He provided a newly created and anonymous email address for a hoped- for reply. In light of the prior reactions to his statements, Nurse Tomlinson did not address the unnecessary procedures in the letter, as it was his intention to discuss in person the unnecessary procedures he had witnessed once granted a meeting with HCA of?cials. 23. Soon thereafter, HCA of?cials emailed Nurse Tomlinson and requested a meeting. Following this, Stephen Johnson, Ethics Of?cer for South Florida, called Nurse Tomlinson to arrange a meeting. In their meeting in the fall of 2010 at Sonny?s BBQ restaurant in Port St. Lucie, Nurse Tomlinson discussed his concerns about the performance of unnecessary stents. He speci?cally mentioned the incident with SHADANI, when SHADANI inserted a stent in a patient with no more than a ten percent blockage. Johnson appeared to be interested in Tomlinson?s information about unnecessary stents. Johnson asked about the number of times it may have happened. Tomlinson replied ?at least a dozen.? Nurse Tomlinson was aware that Dr. Shakoor Arain was also performing unnecessary procedures at LAWNWOOD. Nurse Tomlinson observed Dr. Arain bringing multiple patients from out of town to the LAWNWOOD cath lab and performing unnecessary stent insertions. After their meeting, Johnson told Nurse Tomlinson that he would conduct an investigation and get back to him. However, Nurse Tomlinson never heard from Johnson again. 24. Less than two months after Nurse Tomlinson?s meeting with Johnson, HCA conducted an investigation of cardiac procedures at LAWNWOOD. Johnson prepared a memorandum substantiating Nurse Tomlinson?s allegations that unnecessary procedures were being performed at LAWNWOOD. 25. Additionally, a 2010 HCA review authored by George Ebra found that approximately 1,200 surgeries were performed on patients who did not have serious heart disease at HCA hospitals, including surgeries performed at LAWNWOOD by Defendant SHADANI. 26. On August 6, 2012, the New York Times published an article with the headline ?Hospital Chain Inquiry Cited Unnecessary Cardiac Work?. (Exhibit The article noted that an independent heart specialist reviewing 17 of Defendant cases, found problems with 13 of the cases, included unwarranted cardiac stents in patients who were needlessly subjected to multiple procedures. 27. Even though Defendants LAWNWOOD, HCA Inc., and HCA HOLDINGS knew that Defendant SHADANI was performing unnecessary surgeries at LAWNWOOD and placing patients in harm?s way, Defendant privileges were never suspended or revoked. 28. Defendant SHADANI maintains full privileges to perform cardiac procedures at LAWNWOOD as of the filing of this Complaint. FACTS GIVING RISE TO THE CLAIM 29. On August 20, 2013, Plaintiff JOHN AUSTGEN presented to Defendant SHADANI for complaints of near syncope for approximately one and a half years. Plaintiff JOHN AUSTGEN indicated that his most recent episode occurred a week prior to seeing Defendant SHADANI. Plaintiff JOHN AUSTGEN reported that he was watching television and suddenly started sweating. 30. Defendant SHADANI noted on August 20, 2013 that Plaintiff JOHN AUSTGEN was very active physically and went to the every other day and did not experience any dif?culty breathing or palpations or any for that matter during his intense activity. 31. An EKG performed in Defendant of?ce revealed sinus bradycardia with ?ndings consistent with anteroseptal wall myocardial infarction of undetermined age, probably old. 32. On August 28, 2013, Plaintiff JOHN AUSTGEN underwent an echocardiogram which was essentially normal. 33. The same day, Plaintiff JOHN AUSTGEN also underwent a 24 hour Holter Monitor. The Holter Monitor was returned to Defendant of?ce on August 29, 2013. 34. The Holter Monitor report was unsigned and undated. 35. Plaintiff JOHN AUSTGEN was told by Defendant of?ce that he had complete heart block and that Plaintiff JOHN AUSTGEN needed to immediately go to LAWNWOOD for permanent pacemaker insertion. 36. Defendant SHADANI diagnosed Plaintiff JOHN AUSTGEN with sclerodegenerative conduction system disease of the heart manifesting as third degree or complete heart block. 37. The Holter Monitor did not reveal third degree complete heart block as diagnosed by Defendant SHADANI. 38. The Holter Monitor instead showed a much more benign type of heart block, second degree Type I, also known as Wenckebach block. 39. Had Plaintiff JOHN AUSTGEN been correctly diagnosed with second degree Type I heart block, he would not have undergone permanent pacemaker implantation. 40. As a result of the erroneous diagnosis of complete heart block by Defendant SHADANI, Plaintiff JOHN AUSTGEN underwent numerous unnecessary surgical procedures at LAWNWOOD. 41. Plaintiff JOHN AUSTGEN was admitted to LAWNWOOD on August 29, 2013. The admitting physician, Dr. Shah, noted that Plaintiff JOHN AUSTGEN had been feeling dizzy for several days but did not document syncope or near syncope. 42. An EKG performed on August 30, 2013 prior to the pacemaker procedure revealed Plaintiff JOHN AUSTGEN to be in normal sinus with no evidence of complete heart block. 43. Despite the normal EKG, Defendant SHADANI performed permanent pacemaker insertion on August 30, 2013, at LAWNWOOD. 10 44. Following the initial pacemaker insertion procedure, a routine chest x-ray performed in the recovery room showed that the atrial lead had dislodged from its attachment to the atrial wall. 45. Plaintiff JOHN AUSTGEN was returned to the operating room for pacemaker lead repositioning. However, the atrial lead once again became dislodged from the atrial wall. 46. Defendant SHADANI, having twice unsuccessfully attempted to place a pacemaker that was never needed, left to go out of town on vacation. 47. Thoracic and vascular surgeon, Terrence Downing, M.D., was consulted to reposition the atrial lead. 48. In his initial consultation note dated August 31, 2013, Dr. Downing pointed out that there was no evidence of complete heart block. 49. On August 31, 2013, Plaintiff JOHN AUSTGEN underwent his third cardiac surgery, this time performed by Dr. Downing who found unsatisfactory RV lead sensing threshold and repositioned the RV lead and dislodged atrial lead. 50. The next day, Plaintiff JOHN AUSTGEN was returned to the operating room for his fourth surgical procedure. Dr. Downing found the RV lead free ?oating. It took Dr. Downing 20 attempts to secure the tip of the RV lead into the myocardium. 51. Shortly after arriving to the recovery room, Plaintiff JOHN AUSTGEN suffered a cardiac arrest. An echocardiogram revealed a pericardial effusion. Plaintiff JOHN AUSTGEN was returned to the operating room for mediastinal exploration. 11 52. Upon return to the operating room, Dr. Downing performed a stemotomy. 53. At approximately ?ve o?clock am. on September 2, 2013, Plaintiff JOHN AUSTGEN started bleeding again and was returned to the operating room for another surgical procedure. Dr. Downing performed mediastinal exploration at approximately eleven o?clock am. on September 2, 2013. Dr. Downing noted a large mediastinal hematoma which was evacuated. Dr. Downing also noted a protruding RV lead, possibly perforating a branch of the coronary artery. 54. Plaintiff JOHN AUSTGEN remained at LAWNWOOD until he was discharged on September 14, 2013. 55. As a result of Defendant improper diagnosis of complete heart block and Defendants LAWNWOOD, HCA Inc., and HCA failure to properly supervise, credential and retain Defendant SHADANI, as well as have a comprehensive program to ensure the safety of its patients, Plaintiff JOHN AUSTGEN underwent numerous unnecessary medical procedures. As a result of the unnecessary medical procedures, Plaintiff JOHN AUSTGEN suffered permanent, severe and debilitating injuries. DAMAGES 56. As a result of the negligence of Defendants, Plaintiff JOHN AUSTGEN sustained bodily injury with resulting pain and suffering, disability, physical impairment, dis?gurement, mental anguish, inconvenience, loss of the capacity for the enjoyment of life, expense of hospitalization, medical care and nursing treatment and other care and treatment. These losses are permanent and Plaintiff will suffer said losses into the future. 12 COUNT I: NEGLIGENCE OF ABDUL SHANDANI M.D. 57. Plaintiff realleges and incorporates by reference all allegations contained in paragraphs 1 through 56, and further alleges: 58. At all times material hereto, Defendant SHADANI had a duty to provide reasonable care to Plaintiff JOHN AUSTGEN in accordance with the accepted standards of care and that level of care, skill and treatment, which in light of all relevant circumstances, is recognized as acceptable and appropriate by similar and reasonably careful healthcare providers in St. Lucie County, Florida or other similar medical communities. 59. At all times material hereto, Defendant SHADANI was negligent and deviated from the acceptable standards of medical care and treatment in the following respects: a. Failure to perform a proper medical evaluation to determine whether the patient was a proper candidate for pacemaker implantation; b. Performing an unnecessary medical procedure that put the patient?s life at risk; c. Failing to correctly interrupt the August 28, 2013 Holter Monitor study; d. Diagnosing complete heart block in a patient with chronic and nonspeci?c complaints and who had Holter Monitor and EKG results without evidence of a complete heart block; and e. Failing to provide the level of care, skill, and treatment which, in light of all relevance surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent healthcare providers. 13 60. As a direct and proximate result of the Defendant?s negligence, Plaintiff JOHN suffered signi?cant and permanent debilitating injuries. WHEREFORE, Plaintiff, JOHN demands judgment in his favor against Defendant ABDUL SHANDANI, M.D., for compensatory damages, costs, and for such other relief as their Court may deem just and proper. COUNT II. BATTERY: ABDUL SHADANI, M.D 61. Plaintiff realleges and incorporates by reference all allegations contained within paragraphs 1 through 60, and further alleges: 62. At all times material hereto, Defendant SHADANI intended to perform surgery on Plaintiff JOHN even though Defendant SHADANI knew that surgery was not necessary. 63. On August 29, 2013, Defendant SHADANI performed a pacemaker implantation even though Plaintiff JOHN did not need a pacemaker. Defendant SHADANI performed the unnecessary surgery in order to bill Plaintiff JOHN insurance company, Medicare. 64. At all times material hereto Defendant SHADANI misled Plaintiff JOHN into believing that he had complete heart block and needed emergency pacemaker implantation. Defendant SHADANI obtained consent from Plaintiff JOHN under false pretenses. 65. As a result of Defendant actions, Plaintiff JOHN underwent numerous unnecessary medical procedures. 66. As a result of Defendant SHADANI performing unnecessary surgeries, Plaintiff JOHN suffered signi?cant and permanent debilitating injuries. 14 WHEREFORE, Plaintiff, JOHN AUSTGEN, demands judgment in his favor against Defendant ABDUL SHANDANI, M.D., for compensatory damages, costs, and for such other relief as their Court may deem just and proper. COUNT INTENTIONAL INF LICTION OF EMOTIONAL DISTRESS: ABDUL SHADANI, MD. 67. Plaintiff realleges and incorporates by reference all allegations contained within paragraphs 1 through 60, and further alleges: 68. At all times material hereto, Defendant SHADANI intended to perform surgery on Plaintiff JOHN AUSTGEN, even though Defendant SHADANI knew or should have known that surgery was not necessary. 69. On August 29, 2013, Defendant SHADANI performed a pacemaker implantation even though Plaintiff JOHN AUSTGEN did not need a pacemaker. Defendant SHADANI performed the unnecessary surgery in order to bill Plaintiff JOHN insurance company, Medicare. 70. At all times material hereto Defendant SHADANI mislead Plaintiff JOHN AUSTGEN into believing that he had complete heart block and needed emergency pacemaker implantation. Defendant SHADANI obtained consent from Plaintiff JOHN AUSTGEN under false pretenses. 71. As a result of Defendant actions, Plaintiff JOHN AUSTGEN underwent numerous unnecessary medical procedures. 72. Defendant conduct was intentional. 73. Defendant conduct was outrageous, such that it is odious and utterly intolerable in a civilized community. 15 74. Defendant conduct caused Plaintiff JOHN AUSTGEN severe emotional distress. WHEREFORE, Plaintiff, JOHN AUSTGEN, demands judgment in his favor against Defendant ABDUL SHANDANI, M.D., for compensatory damages, costs, and for such other relief as their Court may deem just and proper. COUNT IV: FRAUD: ABDUL SHADANI, MD. 75. Plaintiff realleges and incorporates by reference all allegations contained within paragraphs 1 through 60, and further allege: 76. On August 29, 2015, Defendant SHADANI told Plaintiff JOHN AUSTGEN that he had complete heart block and needed to undergo permanent pacemaker implantation. 77. Defendant SHADANI knew that Plaintiff JOHN AUSTGEN did not have complete heart block and did not need a permanent pacemaker when he made this statement. 78. Defendant SHADANI made the false statement to induce Plaintiff JOHN AUSTGEN to consent and undergo a procedure that was not medically necessary. Defendant SHADANI did this so that he could bill Plaintiff JOHN insurance company, Medicare. 79. Plaintiff JOHN AUSTGEN relied upon Defendant false statements and agreed to undergo permanent pacemaker implantation surgery. 80. As a result of his reliance upon Defendant false statement, Plaintiff JOHN AUSTGEN underwent numerous unnecessary medical procedures and suffered signi?cant and permanent debilitating injuries. 16 81. WHEREFORE, Plaintiff, JOHN AUSTGEN, demands judgment in his favor against Defendant ABDUL SHANDANI, M.D., for compensatory damages, costs, and for such other relief as their Court may deem just and proper. COUNT V: NEGLIGENCE OF LAWNWOOD REGIONAL MEDICAL CENTER HEART INSTITUE IN HIRING, SUPERVISION, TRAINING OR RETENTION CLAIM PURSUANT TO FLORIDA STATUTE ?766.110 82. Plaintiff realleges and incorporates by reference all allegations contained within paragraphs 1 through 60, and further allege: 83. Defendant LAWNWOOD owed a duty to ensure that those providing care in their facility, including but not limited to Defendant SHADANI, were competent to provide appropriate treatment and care on patients such as Plaintiff JOHN AUSTGEN. 84. Defendant LAWNWOOD failed to appropriately select and retain competent medical professionals by granting Specific privileges and allowing to provide care in its facility, including but not limited to Defendant SHADANI when it knew or should have known that the physician was not competent or capable of providing the level of care and treatment that was required for patients such as Plaintiff JOHN AUSTGEN. 85. Defendant LAWNWOOD failed to ensure that Defendant SHADANI was properly monitored, trained, and/or supervised. 86. Defendant LAWNWOOD knew or should have known that its medical professionals including, Defendant SHADANI failed to possess the required training, skill and judgment to properly and safely treat and provide the necessary care to patients such as Plaintiff JOHN AUSTGEN. 17 87. Defendant LAWNWOOD had a duty to assure comprehensive risk management and the competence of Defendant, SHADANI, through careful selection and review, under Florida Statute ?766.1 10(1). Defendant LAWNWOOD had a duty to: a. Adopt written procedures for the selection of staff members and periodically review the medical care and treatment rendered to patients like Plaintiff JOHN b. Adopt a comprehensive risk management program which fully complied with Statute 395.0197, Florida Statutes; and c. Initiate and diligently administer" a medical review and risk management process including supervising Defendant SHADANI to the extent necessary to ensure that such medical review and risk management processes were being diligently carried out. 88. Defendant LAWNWOOD had a duty and responsibility to conduct a background investigation of Defendant SHADANI to determine his suitability for treating patients like Plaintiff JOHN AUSTGEN. 89. Defendant LAWNWOOD had a duty pursuant to its Code of Conduct to make patient safety paramount; to have a comprehensive and effective approach to handling the issues of credentialing and privileging of members of its medical staff and to create an effective peer review mechanism within the medical staff. 90. Defendant LAWNWOOD knew or should have known that Defendant SHADANI had been putting patients at risk by performing medical procedures in patients that were not medically indicated. 91. Defendant LAWNWOOD failed to properly investigative allegations that Defendant SHADANI was performing unnecessary medical procedures such that Defendant SHADANI was allowed to continue on staff with full privileges. Defendant LAWNWOOD placed pro?ts over patient safety by allowing Defendant SHADANI to 18 treat patients even though it knew or should have known that Defendant SHADANI was performing unnecessary medical procedures on patients at the hospital. 92. As a result, Defendant SHADANI being negligently hired, retained, supervised, Defendant LAWNWOOD failed to do one or more of the following acts, any or all of which were departures from the acceptable professionals? standards of care in St. Lucie County, Florida, or any other similar medical community: a. Failing to ensure that Defendant SHADANI was competent to care for Plaintiff JOHN AUSTGEN or any other similar-situated patient. Failing to properly monitor, access, supervise, discipline, train or review the Defendant SHADANI to the extent necessary to care for Plaintiff JOHN Failing to investigate Defendant SHADANI for performing unnecessary medical procedures; Failing to adequately discipline Defendant SHADANI or revoke his privileges in response to Defendant SHADANI performing unnecessary medical procedures; Negligently entrusting or retaining Defendant SHADANI which would foreseeably permit him to treat patients like Plaintiff JOHN AUSTGEN. 93. As a direct and proximate result of the Defendant?s negligence, Plaintiff JOHN AUSTGEN suffered signi?cant and permanent debilitating injuries. WHEREFORE, Plaintiff JOHN AUSTGEN demands judgment in his favor against Defendant LAWNWOOD MEDICAL CENTER, INC. d/b/a LAWNWOOD REGIONAL MEDICAL CENTER HEART INSTITUTE, for compensatory damages, costs, and for such other relief as this Court may deem just and pr0per. 19 COUNT VI: DIRECT AND VICARIOUS LIABILITY OF HCA INC., f/k/a HCA- THE HEALTHCARE COMPANY FOR THE NEGLIGENCE OF ITS AGENTS, APPARENT AGENTS, SERVANTS EMPLOYEES 94. Plaintiff realleges and incorporates all allegations contained in paragraphs 1 through 60, and further alleges: 95. At all times material hereto, Defendant HCA INC. had a duty individually and by and through its agents, apparent agents, servants, and/or employees, to provide proper medical care to Plaintiff JOHN AUSTGEN in accordance with accepted standards of care in St. Lucie County, Florida, or other similar medical communities. 96. At all times material hereto, Defendant HCA INC. is directly and vicariously responsible for the actions of Defendant LAWNWOOD, through its doctors, agents, apparent agents, servants, administration and employees, including but not limited to Defendant SHADANI. At all times material hereto, Defendant HCA INC., acted through its doctors, agents, apparent agents, servants, administration and employees, including but not limited to Defendant SHADANI who were acting within the course and scope of their agency, apparent agency, servant to or employment with HCA INC. 97. Defendant HCA right to control the actions of its agents, apparent agents, servants, administration and employees is established by the following facts: a. HCA INC. and LAWNWOOD share the same address; b. HCA INC. and LAWNWOOD share some of the same officers and directors; c. All HCA INC. af?liated staff members and employees (including LAWNWOOD staff members and employees) are required to abide by the HCA Code of Conduct; 20 d. All HCA INC. af?liated staff members and employees (including LAWNWOOD staff members and employees) are required to abide by the Corporate Integrity Agreement. e. HCA INC. owns a majority of stock in LAWNWOOD and can elect its directors who can hire, ?re and control the physicians at Lawnwood and can completely control Lawnwood to whatever extent HCA INC. wants. 98. Through the Lawnwood Hospital bylaws, Lawnwood Rules and Regulations, HCA Code of Conduct and HCA Corporate Integrity Agreement, Defendant HCA INC. exercised direct control over Defendant LAWNWOOD. For example, Corporate Integrity Agreement required that all employees and staff members be trained on policies and procedures. Defendant HCA INC, had such explicit right of control over each HCA Hospital, including Defendant LAWNWOOD, that it was able to enter into the attached Corporate Integrity Agreement (Exhibit that was binding on its subsidiaries, including LAWNWOOD, with the US. Department of Health and Human Services. Through this direct control, Defendant HCA INC. decided what doctors would be selected and retained to practice medicine at Lawnwood including the co-defendant named herein. 99. Prior to Plaintiff JOHN admission, Defendant HCA INC. instituted strict policies to be followed for treatment and speci?c policies for the selection and retention of medical staff members; adOpting a comprehensive risk management program which fully complied with statute 395.0917, Florida Statute; in initiating a medical review and risk management process to supervise physicians and medical staff to ensure that medical review and risk management processes were being diligently carried out. Within these Speci?c policies, HCA INC. instituted obligations on the part of LAWNWOOD. Defendants HCA INC. and LAWNWOOD knew their administration 21 and employees were not following these strict policies and were failing to appropriately implement the policies to ensure patient safety. Defendants HCA INC and LAWNWOOD allowed this conduct to continue, and by so doing, they consciously disregarded patient safety directly resulting in staff members violating their policies and their treatment. 100. Through its direct involvement ensuring the competency of its staff members and employees as required by Florida Statutes 766.110, Defendant HCA INC, was aware of the conduct outlined herein, yet consciously permitted the physicians, administration, staff, servants, agents, and apparent agents and employees to continue to ignore policies and directly retained the Defendant SHADANI as a member of its hospital staff, directly and fraudulently violating Defendant own hospital Bylaws and Rules and Regulations. 101. Defendant HCA INC by and through its doctors, agents, apparent agents, servants, administration and employees, including but not limited to Defendant SHADANI, deviated from the prevailing standard of medical care and treatment of Plaintiff JOHN AUSTGEN and breached its duty to Plaintiff JOHN AUSTGEN in the following respects, inter alia: a. Knowingly permitting physicians to perform unnecessary medical procedures; b. Knowingly permitting physicians to fail to perform proper medical evaluations of patients to appropriately determine if they were proper candidate for medical procedures. 102. Furthermore, Defendant HCA IN C., through its direct involvement in assuring the competency and physicians as required by Florida Statute 766.110, knew or should have known that Defendant SHADANI failed to possess the required training, 22 skill and/or judgment to properly and safely treat patients such as Plaintiff JOHN AUSTGEN. 103. Defendant HCA INC., through its direct involvement in assuring the competency of staff members and physicians as required by Florida Statue 766.110, and pursuant to the obligations set forth in the Code of Conduct, knew or should have known that Defendant SHADANI was performing unnecessary medical procedures. 104. As a result of Defendant SHADANI being negligently hired, retained, supervised, and reviewed, Defendant HCA INC. did or failed to do one or more of the following acts, any or all of which were departures from the acceptable professional standard of care in St. Lucie County, Florida, or any similar medical community: a. Failing to assure that Defendant SHADANI was competent in caring for Plaintiff JOHN AUSTGEN or any other similar situated patient; b. Failing to properly monitor, assess, supervise, discipline, train and review Defendant SHADANI to the extent necessary to care for Plaintiff JOHN c. Failing to perform a background investigation of Defendant SHADANI prior to hiring him; d. Failing to perform and investigation into complaints and that Defendant SHADANI was performing unnecessary medical procedures at e. Failing to act upon the results of any investigation into complaints that Defendant SHADANI was performing unnecessary medical procedures and allowing him to maintain active medical privileges; and f. Negligently entrusting and/or retaining Defendant SHADANI which could foreseeably permit him to treat patients like Plaintiff JOHN AUSTGEN. 23 105. As a direct and proximate result of Defendant?s negligent, Plaintiff JOHN AUSTGEN suffered signi?cant and permanent debilitating injuries. WHEREF ORE, Plaintiff, JOHN AUSTGEN, demands judgment in his favor against Defendant HCA INC., f/k/a HCA- THE HEALTHCARE COMPANY, for compensatory damages, costs and for such other relief as this Court may deem just and proper. COUNT VII: DIRECT AND VICARIOUS LIABILITY OF HCA HOLDINGS, INC FOR THE NEGLIGENCE OF ITS AGENTS, APPARENT AGENTS, SERVANTS EMPLOYEES 106. Plaintiff realleges and incorporates by reference all allegations contained in paragraphs 1 through 60, and ?irther alleges: 107. At all times material hereto, Defendant, HCA HOLDINGS had a duty individually and by and through its agents, apparent agents, servants, and/or employees, to provide proper medical care to JOHN AUSTGEN in accordance with accepted standards of care in St. Lucie County, Florida, or other similar medical communities. 108. At all times material hereto, Defendant, HCA HOLDINGS is directly and vicariously responsible for the actions of Defendant LAWNWOOD, through its doctors, agents, apparent agents, servants, administration and employees, including but not limited to Defendant SHADANI. At all times material hereto, Defendant HCA HOLDINGS, acted through its doctors, agents, apparent agents, servants, administration and employees, including but not limited to Defendant SHADANI, who were acting within the course and scope of their agency, apparent agency, servant to or employment with HCA HOLDINGS. 24 109. Defendant HCA right to control the actions of its agents, apparent agents, servants, administration and employees is established by the following facts: a. HCA HOLDINGS and LAWNWOOD share the same address; b. HCA HOLDINGS and LAWNWOOD share some of the same of?cers and directors; 0. All HCA HOLDINGS af?liated staff members and employees (including LAWNWOOD staff members and employees) are required to abide by the HCA Code of Conduct; d. All HCA HOLDINGS af?liated staff members and employees (including LAWNWOOD staff members and employees) are required to abide by the Corporate Integrity Agreement. e. HCA HOLDINGS owns a majority of stock in LAWNWOOD and can elect its directors who can hire, ?re and control the physicians at Lawnwood and can completely control Lawnwood to whatever extent HCA HOLDINGS wants. 110. Through the Lawnwood Hospital bylaws, Lawnwood Rules and Regulations, HCA Code of Conduct and HCA Corporate Integrity Agreement, Defendant HCA HOLDINGS exercised direct control over Defendant LAWNWOOD. For example, Corporate Integrity Agreement required that all employees and staff members be trained on policies and procedures. Defendant HCA HOLDINGS had such explicit right of control over each HCA Hospital, including Defendant LAWNWOOD, that it was able to enter into the attached Corporate Integrity Agreement (Exhibit that was binding on its subsidiaries, including LAWNWOOD, with the US. Department of Health and Human Services. Through this direct control, Defendant HCA HOLDINGS decided what doctors would be selected and retained to practice medicine at Lawnwood including the co-defendant named herein. 25 11]. Prior to Plaintiff JOHN admission, Defendant HCA HOLDINGS instituted strict policies to be followed for treatment and speci?c policies for the selection and retention of medical staff members; setting forth adopting a comprehensive risk management program which fully complied with statute 395.0917, Florida Statute; in initiating a medical review and risk management process to supervise physicians and medical staff to ensure that medical review and risk management processes were being diligently carried out. Within these speci?c policies, HCA HOLDINGS instituted obligations on the part of LAWNWOOD. Defendants HCA HOLDINGS and LAWNWOOD knew their administration and employees were not following these strict policies and were failing to appropriately implement the policies to ensure patient safety. Defendants HCA HOLDINGS and LAWNWOOD allowed this conduct to continue, and by so doing, they consciously disregarded patient safety directly resulting in staff members violating their policies and their treatment. 112. Through its direct involvement ensuring the competency of its staff members and employees as required by Florida Statutes 766.110, Defendant HCA HOLDINGS was aware of the conduct outlined herein, yet consciously permitted the physicians, administration, staff, servants, agents, and apparent agents and employees to continue to ignore policies and directly retained Defendant SHADANI as a member of its hospital staff, directly and fraudulently violating Defendant own hospital Bylaws and Rules and Regulations. 113. Defendant HCA HOLDINGS by and through its doctors, agents, apparent agents, servants, administration and employees, including but not limited to Defendant SHADANI deviated from the prevailing standard of medical care and treatment of 26 Plaintiff JOHN AUSTGEN and breached its duty to Plaintiff JOHN AUSTGEN in the following respects, inter alia: a. Knowingly permitting to perform unnecessary medical procedures; b. Knowingly permitting physicians to fail to perform proper medical evaluations of patients to appropriately determine if they were proper candidate for medical procedures. 114. Furthermore, Defendant HCA HOLDINGS through its direct involvement in assuring the competency and physicians as required by Florida Statute 766.110, knew or should have known that Defendant SHADANI failed to possess the required training, skill and/or judgment to properly and safely treat patients such as Plaintiff JOHN AUSTGEN. 115. Defendant HCA HOLDINGS, through its direct involvement in assuring the competency of staff members and physicians as required by Florida Statue 766.110, and pursuant to the obligations set forth in the Code of Conduct, knew or should have known that Defendant SHADANI was performing unnecessary medical procedures. 116. As a result of Defendant SHADANI, being negligently hired, retained, supervised, and reviewed, Defendant HCA HOLDINGS did or failed to do one or more of the following acts, any or all of which were departures from the acceptable professional standard of care in St. Lucie County, Florida, or any similar medical community: a. Failing to assure that Defendant SHADANI was competent in caring for Plaintiff JOHN AUSTGEN or any other similar situated patient; b. Failing to properly monitor, assess, supervise, discipline, train and review Defendant SHADANI to the extent necessary to care for Plaintiff JOHN 27 c. Failing to perform a background investigation of Defendant SHADANI prior to hiring him; d. Failing to perform and investigation into complaints that Defendant SHADANI was performing unnecessary medical procedures at e. Failing to act upon the results of any investigation into complaints that Defendant SHADANI was performing unnecessary medical procedures and allowing him to maintain active medical privileges; and f. Negligently entrusting and/or retaining Defendant SHADANI which could foreseeany permit them to treat patients like Plaintiff JOHN AUSTGEN. 117. As a direct and proximate result of Defendant?s negligent, Plaintiff JOHN AUSTGEN suffered signi?cant and permanent debilitating injuries. WHEREFORE, Plaintiff JOHN AUSTGEN demands judgment in his favor against Defendant HCA HOLDINGS, for compensatory damages, costs and for such other relief as this Court may deem just and proper. DEMAND FOR JURY TRIAL Plaintiff JOHN AUSTGEN hereby demands trial by jury on all issues so triable as a matter of right. 28 CERTIFICATE OF GOOD FAITH Pursuant to Florida Statute ?766.203, the undersigned attorney of records, does hereby certify that a reasonable investigation has been conducted as to the matters alleged herein and it has been determined that there are grounds for a good faith belief that there has been some negligence and medical malpractice in the care and treatment of John Austgen and that grounds exist for the ?ling of this action against the Defendants. DATED this _1_1th_ day of Haifa/tag ,2016. SCHULER, I-IALVORSON, WEISSER ZOELLER, PA Attorneys for Plaintiffs Barristers Building, Fourth Floor 1615 Forum Place West Palm Beach, FL 33401 (561) 689-8180 (561) 684-9683 facsimile By: MICHAEL V. BAXTER Florida Bar No: 90662 29 Filing 37681698 E-Filed 02/11/2016 09:30:00 AM A CORPORATE INTEGRITY AGREEMENT BETWEEN THE OFFICE or INSPECTOR GENERAL or am: Deranmm or HEALTH AND HUMAN SERVICES AND Comm 1. ma?a Healthcare Company hereby enters into this Corporate Integrity Agreement with the O?ice of Inspector General of the United States Department of Health and Human Services to promote compliance by itself, its subsidiaries, and their employees, contractors, agents, and physicians with the requirements of Medicare, Medicaid and all other Federal health care programs (as de?ned in 42 U.S.C. collectively referred to as the ?Federal health care programs?) This CIA shall be applicable only to those operations of HCA that are subject to United States law and regulations. compliance with the terms and conditions in this CIA shall constitute an element of present responsibility with regard to participation in the Federal health care programs. Whenever the term is used in this out, it includes all ofHCA?s subsidiaries, as de?ned in this agreement. Contepporaneously with this CIA, HCA is entering into a Settlement Corporate Integrity Agreement HCA -- The Company 1 EXHIBIT Agreement with the United States, and this CIA is incmpotated by reference into the Settlement Agreement. HCA cinrently operates an Ethics and Compliance Program. whichHCA agrecstoopeiate in amannerconsistaitwith their.th ofthis CIA. A. m. The period of the compliance obligations assmied by HCA under this CIA shall be eight years from the e??ective date of this CIA (unless otherwise speci?ed). The e?'ective date of this CIA shall be the date that the court(s) accept the plea(s) and impose a sentence in the ?eriminal proceeding related to the plea agreement entered into between HCA and the United Stem on or about the date of the signing of this CIA. Sections VII, IX, and XI ofthis CIA shall remain in e??ect until 016 has completed its review of the ?nal annual report and any additional materials submitted by HCA pursuant to request. The compliance obligations of the Corporate Integity Agreement in place for Lam'er Park Hospital inoGainesville, Georgia, shall not apply to the time period beginning on the e??ec?ve date of this CIA (sections ED, 113, m, V, and v1 ofthe Lanier Park on shall remain in e??ect until 016 has completed its review ofthe most recent annual report and any additional mate-isle submitted by HCA pursuant to request), and upon the e?'ective date of this CIA Lanicr Park Hospital shall be subject to the provisions ofthis CIA to the suite extem as other facilities. IiCA-?Ihcl-Icalthcarccompmy . 2 B. m. For the purposes ofthis CIA, the following terms have the following meanings. 1. Covered Person: (3) any o?eer, director, or employee ofl-ICA or any of its subsidiaries; or any agent or other indiVithral who ?nishes health care items or services to any Federal health care program bene?ciary at a facility owned or operated by HCA or any of its subsidiaries for which HCA or any of its subsidiaries claims reimbmsement from any Federal health care program. Notwithstanding the above, this term does not include part-time or per diem employees, agents or other individuals who are not reasonably expected to work more than 160 hours per year, except that any such individuals shall become ?Covered Persons? at the point when they-work inore than 160 hours dining the calendar year. 2. Subsidiary: any corporation or other entity that provides items or services for which payment may be made by any Federal health care program, or prepares or submits requests for such payment, and in which HCA has at least a 50% ownership interest, or (ii) has at least a 5% ownership interest and either manages or controls. . 3. Covered Conn-actor: any agent or other individual (who is not a covered . person) whoprepares claims, costreports, oratherrequests forreimbursement??om any Federal health care program on behalf of HCA or any of its subsidiaries on a regular basis for more than 80 hours within the calendar year). Corporate lnteg?ity Agreement HCA-Thcl-leahheare Company 3 111- 9W shall ensure that its Ethics and Compliance Program includes the following elements during the term of this CIA. 1. Ethics Compliance and Corporate Emmibilmr Committee of the Board of Directors. HCA currently has an Ethics, Compliance and Corporate Reaponsibility Committee of the Board ofDirectors (?Board Committee?) comprised of . live outside directors of HCA. The Board Committee is responsible for the review of matters relatedto theEthics and Compliance Program. this CIA, and compliancewith requirenlems ofI-?eda-al health care programs. The Board Committee shall meet oi least quarterly. Wh new members of the Board Committee are appointed orthe responsibilities or authorities of the Board Committee are substantially changed, HCA shall notify the 016, in writing, within 15 days of such a change. 2. Senior Vice President?lr Compliance. HCA currently has a Senior Vice President for Ethics, Compliance, and Corporate Responsibility (??SVl?oCompliance?). The SVECompliance is and shall be responsible for deveIOping and implementing policies, procedures, and practices designed to ensure compliance with ?le'requirements set forth inthis CIA andwith the requirents ofthe Federal health carepmgrams. 'Ihe . is and shall be a member of senior management shall make Corporate Integrity Agreemt Company 4 regular (at least quarterly) reports regarding compliance matters directly to the CEO and/or to the Board of Directors (including the Board Committee) of HCA, and shall be authorized to report to-the Board of Directors (including the Board Committee) at any time. The SVP-Compliance shall be responsible for monitoring the day-to-dey activities engaged in by HCA to ?rrther its compliance objectives as well as for any reporting obligations created under this CIA. In the event a new SVP-Cornplianee is appointed or the responsibilities or authorities of the SVP-Compliance are substantially changed, HCA shall notify the 01G, in writing, within 15 days ofsueh a change. 3. Ethics, Compliance and Corporate Rommel-1:9; Department. RCA currently has an Ethics, Compliance and Corporate Responsibility Department Department"). The EC Deparhnent is managed by the SVP-Complianoe and is responsible for the operation of the Bthies and Compliance Program and for compliance with the requirements of this CIA and of the Federal health care proyams. In the event the responsibilities or amhorities of the BC Department are substantially changed, HCA shall notify the 016, inwriting, within 15 days ofsuch a drange. 4. Local Ethics and Compliance O?cers. HCA currently has a Local Ethics and Compliance Of?cer Ceca") at each one facilities (for the purpose ofthis CIA, a ?facility? is any hospital, ambulatory surgery center, clinic or group of clinics. or other location where health care items or services are provided by HCA or one of its HCA-The?enltharcCornpany 5 subsidiaries). Each ECO shall have a?cient managcnt responsibility so as' permit the e??ective performance of his or her cuties. Each ECO is responsible for implementation and oversight of the Ethics and Compliance Program at the facility and for the facility?s compliance with the requirements of this CIA and of the Federal health care programs. HCA shall make proper execution of ECO duties at major component of the performance evaluations ofECOs. HCA shall continually assess the e??ectiVeness ofBCOs and the methods and ?ndings of any such assessments shall be made available to the 016 upon request. HCA shall not implement any substantial change in the responsibilities or authorities of the ECOs relating to Ethics and Compliance Program without prior written approval them the 016. 5. Corporate Ethics and Compliance Committees. HCA currently has a Corporate Ethics and Compliance Steering Committee (?Compliance Steering Committee?). The Compliance Steering Committee is chaired by the and includes the Corporate CEO, COO, the two group presidents, and certain senior vice presidents. The Compliance Steering Committee oversees the e?'ectiveness ofthe Ethics and Cornpliance Program and makes decisions on investments in the Program. The Compliance Steering Committee shall be responsible for overseeing the implementation of the requirements of this CIA. HCA also currently has a Corporate Ethics and Compliance Policy Committee (?Compliance Policy Committee?). The Compliance Comm: mm Await RCA - The Heahhcare Company 6 Policy Committee is chaired by the SVP-Compliance and includes the group CF03, three hospital presidents, a number of senior vice presidmts, egg Internal Audit, General Counsel, Quality, Information Systems, Human Resmn'ces, Government Programs, and executives representing major compliance areas, such as coding, billing, physician relationships, and cost reports. The Compliance Policy Committee reviews and approves all compliance-related policies. The two committees shall conduct at least 12 meetings per year in aggregate. The committees shall keep a record of their proceedings that shall be available to the 016 upon request. 6. Hospital Compliance Committees. Each Hospital shall have a Hospital Bthi and Compliance Committee (?Hospital Committee?). The Hospital Committee shall be chaired by the ECO of the mcility and include the heads of each of the facility?s major compliance-related departments. The Hospital Committee shall be responsible for assisting the ECO in immementing the Ethics and Compliance Program, and ensuring compliance by the facility with this CIA and the requirements of Federal health care programs The Hospital Committee shall also he reaponsible for reporting on compliance issues to the ECO. 7. Responsible Execrdives.. HCA has designated certain in?viduals (?Responsible Executives?) to be responsible for development and hnplementation of a portion ofthe Ethics and Compliance Program related to a speci?c compliance risk area. Corpome integ'ity Amen! HCA - The Healthearc Company 7 For example, the Vice President. Health Information Management Services, is the Responsible Executive for coding compliance. The Responsible Executives work with the SVP-Compliance, EC Department, Compliance Policy Committee, and others to develop, oversee, monitor, and implement compliance policies within their designated areas of responsibility. HCA shall not discontinue or materially altet its current Responsible Executive structure without written approval from the 016. B. W. 1. Code ofCanduct. HCA a Code ofConduct. HCA has implemented a program to distribute the Code of Conductto covered persons. HCA shall make the promotion of, and adherence to, the Code of Conduct an elemt in evaluating the perfonnance ofmanagers, supervisors, and all other employees. HCA has implemented a prom-am to obtain an acknowledgment them each covered person that he or she has received HCA's Code of Conduct and understands that it represents the mandatory policies of the organizntion. Within 90 days of the effective date of this CIA, HCA shall obtain a certi?cation them each of its facilities and corporate departments that, based on information and belie? this distribution and acknowledgment process is complete. New covered persons shall receive the Code of Conduct and complete the required acknowledgment within 30 days after becoming a covered person. HCA shall annually review the Code of Conduct and shall make any necessary revisions. These Corporate Integrity Agreement Healthcarc Company 8 revisions shall be distributed as expeditiously as possible after initiating such a change and no later than 30 days after the re?ective date of the revised Code of Conduct. HCA shall implement a program to obtain an aelmowledgment ?om each covered person that hear diehasreceivedtherevised the mandatory policies of the organization, and agees to abide by it. Within 90 days of the e?'ective date of the revised Code of Conduct. HCA shall obtain a certi?cation ?'om each of its facilities and corporate departments that, based on information and belief; this distribution and aclmowledgment process is complete. RCA shall obtain the aclmowledgments and certi?cations described in the preceding two sentences every time that a revised Code of Conduct is distributed (but in any event no less ?eqnently than every three years). 2. Covered Contractor Requirements. HCA shall require a Covered Contractor to: agree to abide by Code of Conduct or adapt its own Code of Conduct substantially to Code of Conduct; distribute either . Code of Conduct or (ii) its Code of Conduct and information about Con?dential Disclosure Program (including the Ethics Line number) to employees working on I-ICA matters; and, certify to HCA that employees working matters have received a copy of Code of Conduct or (ii) its Code of Conduct and information about Con?dential Disclosure Program (including the Ethics Line number). Where the Corporate lntegity Ageunent HCA- The Healtbeae Company 9 Covered Contractor is a solo practitioner, the Covered Contractor must be provided with Code of Conduct and certify that he or she will abide by it. 3. Policies and Pracedw'es. HCA is developing written compliance Policies and Prior to the e??ec?ve date ofthis CIA, HCA has inplemented many such Policies and Procedures and provided them to the 016. HCA shall assess and - update as necessary the Policies and Procedures at least annually and more ?equently, as appropriate. HCA shall provide a summary of changes to its Policies and Procedures in its Annual Reports under this CIA and the current Policies and Procedures shall continue to be available to OIG upon request. HCA represents that it has distributed its Policies and Procedures to its facilities. Compliance staff at both the facilities and the corporate headquarters, including the Responsible Executives, shall be available to explain any and all Policiesandl?rocedures. C. W. HCA shall meet the following training requirements. The training requiremmts are cumulative (not exclusive) so that one person may be required to attend training in several substantive areas in addition to the general training. All training requiremth set forth below in paragraphs 1 to 5 shall be implemented as speci?ed below. With respect to the training required to be provided within a outain time period after the e??ective date of this CIA, HCA need not provide such training to persons who have received training in the six-month period prior to the Corporate My Agreement 10 effective date ofthis CIA, if the training provided meets all the subject matter and duration requirements that would apply to the initial training under the CIA. I. General limiting. HCA shall provide at least two hours of training initially (within90 days ofthe e?ctivedoteofthis CIA)toeach coveredperson, andone hour of re?esher training annually thereafter. The training shall cover Ethics and Compliance Program, its Code ofConduct. and the requirements of this CIA. The training conducted by HCA when it issued its Code of Conduct, One Clear Voice, and its ethics and compliance re?'esher training, Commitrztents We Share, and/or its revised Code of Conduct, A ?aditlon of Caring, (all of which explained Ethics and Compliance Prom and its Code of Conduct) regardless ofthe date the training occurred will satisfy this requirement for training within 90 days notwithstanding the fact that such training did not cover the CIA. Covered persons who have received prior training desm?bed in the previous sentence must receive at least one hour of re?esher training (including discussion of the CIA) during the ?rst year covered by the CIA and annually thereafter. Within 90 days a?er the e??ective date of this CIA. HCA shall notify all covered persons of the erecution of the CIA and provide a summary of the key provisions of this CIA through electronic mail, its internet and/or intranet sites, newslettets, and other appropriate means. All general training conducted after the e?'ective date of this CIA shall include training on the CIA. HOA-The?eahthompany ll 2. Coding mag. HCA shall continue to have in place an introductory training cause for each hospital inpatimt coder, as well as an'lntermedlate coding course. HCA shall provide at least eight hours of coding training to inpatient hospital coders and supervisors within 180 days of the effective date of this CIA. HCA shall maintain its DRG coding come for hospital inpatimt coders accessible through its intranet. HCA . shall maintain and enforce its current policy requiring 30 hours of continuing education annually for hospital inpatient coders. 3. Billing limiting. HCA shall provide training to all individuals (including Laboratory and Business O?ice Diwotors and other billing pasonnel) responsible for Federal health care program billing in their facilities. HCA shall provide at least eight hours of such training within 180 days of the e??ec?ve date of this CIA and during each subsequent year. The training shall include the following subject matters: a. the submission of scam bills for services rendered to Federal health care program bene?ciaries; b. policies, procedures and other requirements applicable to the doctnnentation of medical records; c. the personal obligation of each individual involved in the billing process to ensure that such billings are accurate; d. applicable reimbmsemont statues, regulations. and program requirements and directives; - 12 e. the legal sanctions for improper billings; and examples of proper and improper billing practices. 4. Cost Report ?aming. HCA shall ensure that covered persons who prepare costreports receive at least eight hours of training on preparation of cost reports for Federal health care programs within 180 days ofthe e?'ective date oftllis cm. HCA shall maintain end enforce its malt Inacticc requiring 40 hours ofcontinuing education annually to include Federal and/or state statines, regulations, and guidelines, compliance, and Corporate policies for covered persons who prepare cost reports. 5. fly:sz Relations Training. Within 90 days of the effective date of this CIA and annually thereafter, HCA shall provide at least one hour of training to its Hospital 01303, ores, and all other personnel substantially involved in negotiating or monitoring physician relationships on the stamms and regulations related to hospital/pitysician relationships (including but not limited to 42 U.S.C. 13203-71301) and 1395nn). HCA shall annually distribute its physician relationship policy checklist to such personnel. 6. Overall Congoliance battling. HCA shall continue its process of individual training pro?les its employees. HCA shall pursue the implementation of these training pro?les in order to ensure that all covered persons are familiar with areas of compliance risk reth to their positions. Col-pm malty Aer-canon: Hoaliheale Company 13 7. New Persons. A??ected new cortex-ed persons shall receive the General Training described in section m.c.1 above by the end ofthe ?rst 30 days a?er the person hem work. The orientation training (which is de?ned as all other training required, covered persons (butinnoevmtlaterthanm days a?ertheperson heginswork on the are?tlly quali?edhyvirm of such training to perform wh?ever responsibilities may be assigned to them. In any situation where training requirements have not been completed, a ?rlly trained HCA employee shall care?rlly monitor the work of the untrained person. 8. Covered Contractor Requirements. HCA must document completion of the applicable coding, billing, cost report, or physician relationships training to employees of Covered Contractors working on HCA matters it the Covered Contractor is a solo- . practitioner; (ii) the Covered Contractor was not retained because of its professional erasertise in the area for which training is necessary; or the Covered Contractor has not complied with the requirements of section 1113.2. HCA is responsible for ensuring the expertise and compliance of Covered Contractors. 9. Certi?cation ardRetentton. HCA shall maintain su?cient records to occmred. shallinclude certi?cations ?'orn covered persons that they have attended the required training. The Cor-paralelnteyityAgrcancnt 14 certi?cations may be acquired through: attendance/sigma sheets for in-person group training computer attestations for compmer-based training; or similar mechanisms for other forms of training. Facility ECOs and/or Responsible Executives sha?retainuainingrecords SVP-Complianceto able the SVP-Compliance to report on the training, and provide the speci?c course materials and certi?cations, to the OIG upon request D. W- l. Retention of Independent Revietv Organization. HCA shall retain an entity (or entities), as an accounting, auditing or consulting ?rm (hereina?er ?Independent Review Organization? or to perform review procedures to assist HCA in assessing the adequacy of its Policies and Procedures, Ethics and Compliance Program, its compliance with this CIA. and its compliance with the requirements of Federal health care programs. The reviews shall be perforated annually during the term of the CIA in accordance with the attached workplans. These reviews shall cover the calendar years 2001 through 2008, unless otherwise mei?ed in a workplan. The Independent Review Organization used for each review must have expertise in the matters to be reviewed and partiarlarly mane requirements ofthe Federal health care pray-ants relevant to that area of review. The Independent Review Organimtion must be remitted to conduct the reviews ?)th ?rstwa 90 days ofthe e?'ective date of this CIA. An IRO may engage quali?ed sub-IROs (including, 89PM law ?rms), CorporateIntegrityAgeemmt I-ICA-?lhc?ealthcam Company 15 asnecessaryandHCAshall foranyparticular area of compliance concern if it believes that such di?'erent 1R0 would be better quali?ed HCAshallhavetherightto designate anew atanytimeit chooses. designates anewIRO, itshallprovidewrittennotice totheOIGwithin 15 days ofdesignatingthenewmo. Thiswritten noticewill include the following: the name, address, andpsimary contact person at the newIRO; a brief description ofthe quali?cations ofthe new mo; and a brief description ofthe reasons that anew IRO was designated. . 2. me; ofRevr'ews. The moo) and HCA appropriate internal resetn?ces or directed external resources shall annually perform the reviews described in the audit work plans Workplans?) attached to, and incorporated by reference into, this CIA. The workplans address the following areas: (1) Diamosis Related Groups (2) Laboratory Billing; (3) Outpatient Prospective Payment; and (4) Physician Relationships. The workplans require reviews of systems and processes in place at HCA and its facilities, and of claims by HCA and paid by Federal health care programs (the phySician relationship workplan includes review of physician relationships rather than claims). The reviews of claims more described inthe workplans fall into two general categoi'i: (1) probe samples of a set mnnber of claims (with no pro-determined statistical con?dence or precision parameters); and (2) ?dl samples of claims ?om which an overpayment ainount can be projected to the total population of claims in question . Gospel-ammunition: HGA??lhe?eal?cucCompany l6 within pro-determined. statistical con?dence and precision parameters. HCA and the IRO will evaluate thelRO workplans annually based upon prior year results. HCA will submit revised 1110 work plan(s) to the 016 for its review and action. 3 . Statistical Seraph MApprairalMerhodaIagies?r Reviews. All appraisal, or the review of claims, including probe samples and full samples, shall be conducted in accordance the provisions of AppendixA to this CIA. 4. Ethics and Commune Program Review. The IRO shall conduct a compliance review providing ?ndings regarding whether HCA's Ethics Compliance Program, Policies and Procedtnes, and operations comply with the terms of this CIA. This review shall include section by section ?ndings regarding the requirements of this CIA. In addition, the R0 shall provide ?ndings regarding whether HCA has complied with its obligation tmder the Settlement Agreement: not to resubmit to any Federal health care program payers any previously denied claims related to the conduct addressed in the Settlement Agreement, and its obligation not to appeal any such denials of claims; and not to charge to. or otherwise seek payment from, federal or state payers for unallowable com (as de?ned in the Settlement agreement) and its oblip?on to identify and adjust anyth charges of unallomble costs. 5. Review Raptors. HGA and the M3) shall normally produce reports corresponding to all ofthe required reviews and including all of the required Company . l7 by this section of the CIA, workplans, and the Claims Review Reports described in Appendix A. A complete copy ofall ofthe reports forthe reporting year shall be included in each of Annual Reports to 6. Veri?cation/Validation In the event tint the 016 has reason to believe that any ofHCA?s reviews fail to conform to its obligations under the CIA or indicates improper billings not otherwise adequately addressed in the audit report, and thus determines that it is necessary to conduct an independent review to determine whether or the enent to which HCA is complying withits obligations under this CIA, HCA agees to pay for the reasonable cost of any such review by the 916 or any of its designated agents. Prior to proceeding with such an independent review, the 016 noti?v HCA of its intent to do so and its reasons for believing such a review is necessary, and shall attempt to resolve any issues without proceeding with an independent review. This attempt to resolve issues may include permitting HCA to recommend ?Irther work it the mo may undertake to address the 016?s concerns. However, it shall remain in the sole discretion ofthe 016 to proceed with an independent review as described above. E. HCA has established :1 Con?dential Disclosure Program. HCA provides a toll free ?Ethics Line" to enable employees, contractors, agents or other to disclose, to the BC Department or some other person who is not in the disclosing individual?s chain of command, any. identi?ed issues or questions associated with Policies and Procedures, practices, or operations with Corporate Integrity Agreement HCA ~ml-Iealdzearo Company 18 respect to any Federal health care program. believed by the individual to be inappropriate. HCA shall continue to publicize the of the Ethics Line to all covered persons. HCA has established a Policy governing its handling ofdlselosm'es made through the Ethics Line. shall continue to Operate the Ethics Line through such Policy. HCA shall continue to forbid retribution or retaliation for disclosures and allow for anonymous, con?dential disclosures. The BC Department shall maintain a con?dential disclosure log, which shall include a record and summary of each allegation received, the status of the respective invostigations, and any corrective action taken in response to the investigation. F- 321mm. 1. De?nition. For pmposes of this CIA, an ?Ineligible Person? shall be any individual or entity who: is murently excluded, deban-ed, or otherwise ineligible to participate in the Federal health care programs; or (ii) has been convicted of a criminal o?'ense related to the provision ofhealth care items or services but has not yet been excluded, debatred, or otherwise declared ineligible. 2. Screening Requirements. HCA shall not hire or engage as contractors, or grant stat!? privileges to, any Ineligible Person. To prevent hiring or contracting With, or granting sta? privileges to, any Ineligible Person, HCA shall all prospective employees and prospective contractors priortoengag'ngtheir services andsereen . physicians prior to gaming staff privileges by requiring applicants to disclose Whether they are Ineligible Persons. and (ii) reviewing the General Services Administration's List Corporate Integrity Ageemern l-lCA - ?l'be Hailheare Company 19 of Parties Excluded ?'om Federal Programs (available though the Internet at and the HHNOIG List of Excluded Individuallentities (available through the Internet at (these lists will hereina?er be referred to as the ?Emlusion Lists"). 3. Review andRemoval Requirement. HCA has reviewed its list of mi employees and contractors paid through warmed means against the Exclusion Lists. Within 180 days ofthe listofcurrent physicians with stn?? privileges against the Exclusion Lists. HCA shall review the lists of employees, contractors, and physicians with staff privileges against the Exclusion Lists at least semi-annually during the duration of this CIA. In addition, HCA shall require employees, contractors and physicians with sta? privileges to disclose immediately any debarment, exclusion or other event that makes the person an Ineligible Person. If HCA has notice that an employee, agent, or physician has become an Ineligible Person. HCA shall remove arch person ?'om responsibility for, or involvement with, business operations related to the Federal health care programs and shall remove such person ?om any position for which the person?s salary or the items or services rendered, ordered, or prescribed by the person are paid in whole or part. directly or indirectly, by Federal health careprograms orotherwisewithFederal ?nds reinstated into participation in the Federal health care programs. Comm-ate Integrity Agrecmt Heahhw'e Company 20 4. Pending Charges and Proposed Excitaions. If HCA has notice that an employee or contractor is charged with a criminal o??ensc related to any Federal health care program, or is proposed for exclusion dining his or her employmt or contract, HCA shall take all appropriate actions to ensure that the responsibilities of that employee or contractor him: not and shall not adversely a?'ect the qualityof care rendered to any bene?ciary, patient or resident. or the accmacy orany claims submitted to any Federal health care program. . G. W. Within 30 days of discovery by HCA, HCA shall notify 016, in writing, of any ongoing investigation or legal proceeding conducted or brought by a governmental entity or its agents involving an allegation that HCA has committed a crime or has engaged in fraudulent activities. This nOti?cation shall include a descriptimr of the allegation. the identity of the investigating or prosecuting agency, and the stems of such investigation or legal proceeding. HCA shall also provide written notice to 016 within 30 days of the resolution of the matter, and shall provide 016 with a description of the ?ndings and/or results of the proceedings, if any. . 1. Overpayment: a. Dainition qvaapaerents. For purposes of this CIA, an ?overpayment? shall mean the amount of money HCA has received in exoess' of the amount due and payable under any Federal health HQ-?emmCompany 21 care program requirements. HCA may not subtract any underpayments for purposes of'detennining the amount of relevant ?averpayments.? b. Repairing qvaeipaymentr. It; at any timeyHCA identi?es or [cams ofany overpayments, HCA shall entity the payer (egg, Mediocre ?scal internediary or carrier) and repay any idurti?ed overpayments within 30 days of identi?cation and take remedial steps within 60 days of identi?cation (or such additional time as may he agreed to by the payer) to correct the problem, including preventing the underlying problem and the overpayments from recurring. Also; within 30 days of identi?cation of the overpayment, HCA shall repay the overpayment to the appropriate payer to the extent such overpayment has been quanti?ed (submission of corrected bills in conformance with payer policy within 30 days ?rl?lls this requirement). Ifnot yet quanti?ed. within 30 days of identi?cation, HCA shall notify the payer of its efforts to quantify the overpayment ametmt along with a schedule ofwhen such work is eiqaected to be completed. Noti?cation and repayment to the contractor shoi?d be done in accordance with the contractor policies. For Medicare over-payments identi?ed through Ethics mad Corporate Integrity Agreement 806? The Company 22 Compliance Program and/or the processes required under this CIA, (including internal and RC audits; Ethics Line cases, or other corporate-level monitoring or review), the notice to the contractor must include the information contained on the Overpayment Re?md Form, tothis CIA(unlessthe contraetor has authorized the form not to he submitted for this particular tvpe of claim correction). 2. Reportable Events. a. De?nition of Reportable Event. For purposes of this CIA. a "Reportable Event? means anything that involves: a substantial overpayment; or (ii) a matterthat a reasonable person would consider a potential violation of any criminal, civil, or adminisn'ative statute or regulation applicable to any Federal health care program for which criminal penalties, civil monetary penalties, or exclusion may be authorized. A Reportable Event may be the result of an isolated event or a series of occurrences. b. Reporting ofReportabIe Events. determines that there is a Reportable Event, HCA shall notify OIG, in writing, within 30 Corporate integrity Agreement HCA??lhel-lealthcaro my 23 days of making the determination that theReportable Event exists. The report to the 016 shall include the following information: ComthyAgreeme-nt l-lCA-The?eal?reatecornpeny Ifthe Reportable Event results in an overpayment, the report to the 016 shall be made at the same time as the noti?cation to the marrequired in section 1113.1, and shall include all ofthe information on the Overpaymth Form, as well as: (A) the payer?s name, and contaet person to whom the overpayment was sent; and (B) the date of the cheek and identi?cation number (or electronic median number) on which the overpaymart was repaid/m?mded; (ii) a complete description of the Reportable Brent, including the relevant facts, persons involved, and legal and Federal health care program authorities implicated; a description of HCA's actions taken to correct the Reportable Event; and (iv) any ?trther steps HCA plans to take to address the Reportable Event and prevent it from reaming. 24 In the context of the self-audit, and settlement discussions related to the issue of physician relationships, certain such relationships have been iden??ed as anomalies. HCA shall take appropriate measures to review these anomalous relationships. Those relationships that are determined by RCA 0 be shall be terminated or antended to conform to Ethics and Compliance Program and the requirements of the Federal health care programs. HCA shall report on these measmes as required in section and all supporting documents shall be available to the 016 upon request. IV- In the event that HCA: pin-chases or establishes a new hospital, freestanding ambulatory stn?gery center, home health agency, or another line of business that provides services that are billed to Federal health care programs; or (2) sells or divests an existing hospital, ?eestanding ambulatory surgery center, orhome health agency, HCA shall notify 016 of this fact within 30 days of the date of purchase, establishment, sale, or divestiture. This noti?cation shall include the location of the Operations), telephone number, fax number. Federal health care prom provider number(s) (if any), and the corresponding payor(s) (contractor speci?c). All covered persons at new locations shall be subject to the requiremants in this CIA that apply to new covered persons (as, completing certi?cations and undergoing training). If HCA sells all of the assets or its Corporate integrity Amen: HCA-- The Healthcare Company 25 ownership interest related to a location, then that location shall no longer be considered part of HCA for the purposes of this CIA. Ifthe location is still owned or operated in whole or in part by HCA or any of its subsidiaries or their successors, then the location shall continue to be considered part of HCA for the purposes ofthis CIA. Ifa hospital or ambulatory surgery center shall no longer be subject to the CIA due to a sale or transfer from HCA, HCA shall require as a condition of the sale that buyer or transferee represents and agees that it has or shall implemmt and maintain with respect to its operations of the facility an effective program to prevent and detect violations of the legal requirements applicable to the delivery of goods and services in connection with any health care bene?ts and that such a program will comply with the proviSions of the US. Sentencing Guidelines relating to corporate compliance programs and will be mindful of any applicable guidance issued by the 016 or other components of and that the buyer or transferee agrees that itwill maintain such program for no less than ?ve years from the date of sale or transfer. v. A. Within 120 days a?erthe e??ective date of this CIA, HCA shall submit a was report to 016 summarizing the status of-its implantation of the requircm?nts of this cm. This Implementation Report shall include: I. the namo, title, address, ?scility name (if applicable), and telephone nmnber of all of the individuals who are in positions, or on committees, Commug?ty Amen: HCA - ?lhe HealthcarcCompany 26 described in section (except that with respect to section MAG only. the SVP-Compliance shall certi?r that the Hospital Committees are in place as required and the information otherwise required by this section shall be available to the 016 upon request); 2. the copy of all Policies and Procedures required by section 111.32 that have not been previously provided to the 016; 3. a description of the training required by section including a description of the targeted audiences and a schedule of when the training sessions were held; 4. a certi?cation by the SVP-Complianee that: a. the Policies and Procedures required by section 1113 have been developed and implemontcd, and have been distributed to all pertinent covered persons; b. all covered pasons have completed the Code of Conduct certi?cation required by' section MB. and c. all covered persons have completed the training and executed the certi?cation required by section 111.0. 5. the identity of the Independent Review Organization(s) and the proposed start and completion date of the ?rst set of reviews by the Independmt Corporate integrity Agreement HCA-?l?bciicelthcarcCompany 27 Review Organiatio?s) and appropriate HCA internal resouces or directed external resources; 6. a summary of personnel actions taken pursuant to section ELF (other than hiring or slanting of staff privileges); 7. a summary of the actions taken to ensurethat the physician relationships identi?ed in the self-audit, and settlanent discussions have been reviewed, and terminated or amended, as appropriate, in conformance with section 1111.; 8. a list of all of locations (including physical locations and mailing addresses), the corresponding name under which each location is doing business, the corresponding phone numbers and fax numbers, each location?s Medicare provider identi?cation number(s), and the contractor?s name and address; and 9. To the extent not already Wired to 016, or if modi?ed, a description ofHCA?s corporate structure, including identi?cation of any parent, sister, and other related companies, subsidiaries and their respective lines of businas. B. W. HCA shall submit to 016 Annual Reports with respect to the stems and ?nding of compliance activities. The ?rst Annual Report shall cover the time period from the efi'ectiye date of this CIAthrough December 31, 2001 and she'll Corporate Integrity Agreement HCA 1h: Realms-me Company 28 be received by the 016 no laterthan April 30, 2002. Subsequent Annual Reports shall cover each of the calendar years 2002 through 2008 and shall be received by the 016 no later than April 30 of the year following the year covered in the report. Each Annual quort shall include: 1. any change in the identity, title, address, facility name (if applicable), telephone number, and position description ofall of the individuals who are in positions, or on committees, described in section (except that with respect to section only, the SVP-Compliance shall certify that the Hospital Committees are in place as required and the information otherwise required by this section shall be available to the OIG upon request); 2. a certi?cation by the SVP-Compliance that: a. all covered persons have completed the annual Code of Conduct certi?cation required by section b. all covered persons have completed the training and executed the certi?cation required by section and c. HCA has complied with the following speci?ed obligations under the Settlement Agreement: not to' resubmit to any Federal health care prom payors any previome denied claims related to the conduct addressed in the Settlemt Agreement, and its obligation not to appeal any such denials of claims; and (ii) not to charge to or Corporate Intcyity Agreement HCA-IheHcahhcare Company 29 otherwiseseekpaymentfrom federalorstatepayors forunallowable costs (as de?ned in the Settlement Agreement) and its obligtion to identify and adjust any past charges of unallowable costs. 3. noti?cation of any changes or amendments to the Policies and Procedtnes refermced insectionlIIB andthereasons forsuch changes changein contractor policy); 4. a complete copy ofthe reports prepared pursuant to the reviews required in section IILD, including a copy of the methodologies used, along with a copy of the engagement letta?; 5. response/corrective action plan to any issues raised in the reviews conducted under section 6. a summary of Reportable Evts required to be identi?ed and reported by section 111.11 and en update on corrective actions taken in response to such Reportable Events; 7. a report of the aggegate overpayments identi?ed through Ethics and Compliance Progam and/or the processes required under this CIA, (including internal and IRO audits, Ethics Line cases, or other corporate- levei monitoring or review) that have been reunited to the Federal health care programs. Overpayment amounts shall be broken down into the following categories: inpatient Medicare; outpatient Medicare; Medicaid Corpmetcinteg'ityAaecment HCA-?i?he?ealthmeCompany 30 (report each applicable state other Federal health care Programs; 8. a copy ofthe con?dential disclosure log required section 111.5 and a description ofany changes to the Con?dential Disclosure Program or Ethics Line referenced in that section; 9. a description of any personnel actions (other than hiring or granting staff privileges) taken by HCA as a result of the obligations in section 1111"; and, with respect to any person that falls within the ambit of section 111.F.4, the name, title. and responsibilities of the person, and the actions taken by HCA in response to the obligations set forth in that section; 10.. a summary describing any ongoing investigation or legal proceeding conducted or brougit by a govental entity involving an allegation that HCA has committed a crime or has engaged in ?'andulent actiyities, Which . is required to be reported by section 111.6. The statement shall include a description of the allegation, the identity of the investigating or prosecuting agency, and the status of such investigation, legal proceeding or requests for information; 11. to the extent that such relationships still exist and have not been appropriately altered andreportedinanearlierreport totheOIG, a summary of the actions taken to ermine that the anomalous physician Corporatelntegrityhyeemmt 31 relationships identi?ed in the investigation, self-amt, and settlement discussions havebeenreviewed, in conformance with section and 12. a description of all changes to the most recently provided list (as updated) of locations (including physical locations and mailing addresses) as required by section VAJ, the corresponding name under which each location is doing business, the corresponding phone numbers and fax numbers, each location?s Federal health care program provider identi?cation number(s), and the contractor name and address that issued each provider identi?cation number. C. The Implanentation Report and Annual Reports shall include a certi?cation by the SVP-Compliance that: (1) except as otherwise explicitly described in the applicable report, HCA is in compliance with all of the requirements of this CIA. to the best of his or her knowledge; and (2) the SVP-Compliance has reviewed the report and has made reasonable inquiry regarding its content and believes that thejnfonnation is accurate and triuh?il. Unless otherwise stated in writing subsequent to the c??ective date of this CIA, all noti?cations and reports required under this CIA shall be submitted to the entities listed below: ace-mummy 32 Civil Recoveries Branch - Compliance Unit O?ice ofCounsel tothelnspecmr General O?ce of Inspector General U.S. Department ofI-Iealth and Human Services Cohen Building, Room 5527 330 Independence Avenue. SW Washington, DC 20201 Phone 202.619.2078 Fax 202.205.0604 Alan Yuspeh Senior Vice President Ethics, Compliance, and Corporate Responsibility HCA - The Healthcare Company - One Park Plan Nashville, TN 37203 Phone 615.344.1005 Fax 613.344.1045 Unless otherwise speci?ed, all noti?cations and reports required by this CIA may be made by certi?ed mail, overnight mail, hand delivery or other means, provided that there is proof that such noti?cation was received. For purposes of this requirement, internal facsimile con?rmation sheets do not constiutte proof of receipt. In addition to any other rights 010 may have by statute, regulation, or contract, 016 or its duly authorised representative(s) may examine books, records, and other documents and supporting materials and/or conduct an on-site review for the Corporate My Amen: RCA - Ibo Healthcare Company 3 3 e??eetiye date of this CIA and concluding at the end of theteun of this CIA, HCA hills to have in place any of the following: a. all of the personnel and committees required in section h. awrittenCode c. Written Policies and Procedures as required in section 1113.2; d. straining programasrequiredin section and e. a Con?dential DiscloaneProgi-am asrequiredin section 111.13; 2. A Stipulated Penalty of $2,500.00 (which shall begin to accrue on-the day after the date the obligation became due) each day HCA fails meet any ofthe deadlines to submit the Implemaitation Report or the Annual Reports to the GIG. 3. A Stipulated Penalty (which shall begin to accrue on the date the failure to comply began) for each dayHCA employs, contracts with, or grants staff privileges to an Ineligible Person and that person: has respmsibility for, or involvement With, business operations related to the Federal health care programs; or (ii) is in a position for which the person?s salary or the items or services rendered, ordered, or prescribed by the person are paid in whole or part. directly ?or indirectly, by Federal health care programs or otherwise with Federal funds (the Stipulated Penalty described in this paramph shall not be demanded for any timepetiod duringwhich HCA Corporate Integ'ity Ayeement HCA-?eMcarcCompany 36 can demonstrate that it did not discover the petson?s exclusion or other ineling after making a reasonable inquiry (as describedin section ELF) astothestatus ofthepetson). 4. A Stipulated Penalty of82,500.00 (which shall begin to accme on the infomationorclocumentation as 5. A Stipulated Penalty (which shall begin to accrue on the date the thilure began) for a failure by HCA to report a Reportable Event, take correc?ve action, and pay the appropriate refunds, as provided in section . 6. A Stipulated Penalty $32,000.00 (which shall begin to accrue 10 days I alter the date that 016 provides notice to HCA of the failtn'e to comply) for each day -HCA fails to comply fully and adequately with any obligation of this CIA and such failure is not already subject to a penalty in section through 5 abovel In its notice to HCA, the 016 shall state the speci?c gromds for its detennination that the HCA has failed to comply fully and adequately with the CIA obligation(s) at issue. 3- 1. DemamILetter. Upon a ?nding that HCA has failed to comply with any ofthe obligations desa-ibed in section XAand determine-them Stipulated Penalties are appropriate, 016 shall notify HCA on?: ?ilure to comply; and the 016?s exercise of its comments! right to demand payment of the Stipulated Penalties (this noti?cation is hereina?er referred to as the ?Demand Lettei?). Within 10 days alter Commuting-ime Hen-rhean 37 receiving the Demand Letter, HCA shall either: cure the breach to the 016?s satisfaction and pay the applicable stipulated penalties; or request a hearing before an HHS administrative law judge to disputethe OlG?s detenninatiun of noncompliance, pursuant to the agreed-upon provisions set forth below in section X.D. In the event HCA elects to request an ALI hearing, the Stipulated Penalties shall continue to accrue until HCA cures, to the 016?s satisfaction, the alleged breach in dispute. Failtue allowedtime period shall be considered a material breach of this CIA and shall be grotmds for exclusion under section KC. 2. Hmer Written Requests for Extension. HCA may submit a timely written request for an extension of time to paime any act or ?le any noti?cation or reportrequired by this CIA. Notwithstanding any other provision in this section, if 016 grants the timely written request with respect to an act, noti?cation, or report, Stipulated Penalties for failure to perform the act or ?le the noti?cation or report shall not begin to accrue until one day after HCA fails to meet the revised deadline set by the 016. Notwithstanding any other provision in this section, ifOlG denies such a timely written request, Stipulated Penalties for failure to perform the act or ?le the noti?cation or report shall not begin to accrue until two business days atter HCA receives 016?s written denial of arch request. A "timely written request? is de?ned as a request in writing-received by Cupomte integrity Agreement 33 016 at least ?ve business days prior to the date by which any actis due to be performed ?led. 3. Form ofPayment. Payment ofthe Stipulated Penalties shall be made by certi?ed or cashier?s check, payable to ?Secretary ofthe bepamnent ofI-Iealth and Human Services,? and submitted to 016 at the address set forth in section VI. . 4. Mependence?'om Material Breach Determination. Except as otherwise noted, these provisions for payment of Stipulated Palalties shall not a?'ect or otherwise set at statidard for the 016?s determination that HCA has materially breached this cm. which decision shall be made at the 016's discretion and governed by the provisions in section KC, below. C. 1. Notice of Material Breach and Intent to Exclude. The parties agree that a material breach of this CIA by HCA constitutes an independent basis for 016 to exclude HCA and/or any of its subsidiaries from participan?on in the Federal health care programs (as de?ned in 42 use 5 Upon a determination by me that HCA has materially breached this CIA and that exclusion should imposed, the 016 shall notify HCA by certi?ed mail of: material breach; and intent to exercise its cont-actual right to impose exclusion (this noti?cation is hereinafter referred to as the ?Notice of Material Breach Letter"). memw RCA - net-{alliance Company 39 2. to Cure. HCA shall have 30 days a?er receiving the Notice ofMeterial Breach Letter to demonstrate to the OIG?ssatis?ction that: a. b. c, period, butthat: begunto take actiontocmethe material breach; (ii) HCA is pm?ng such action with due diligence; and HCA has provided to 016 a reasonable timetable for curing the material breach. 3. Exclusion Letter. If at the conclusion ofthe 30-day period, HCA fails to satisfy the requirements of 'section x02, 016 may exclude HCA and/or any of its subsidiaries ?'om participation in the Federal health are programs. 016 shall not:in HCA in waiting of its determination to exclude HCA and/or any of its subsidiaries (this letter shall be referred to hereinafter as the ?Exclusion letter?). Subject to the Dispute Resolution provisions in section XD, below; the exclusion shall go into effect 30 days a?er the date of the Exclusion Letter. The exchsion shall have national e?ect and shall also apply to all other federal procurement and non-procurement programs. and/or any of its subsidiaries is excluded under the provisicms of this CIA, HCA may seek reinstatement to the provisions at 42 C.F.R. 1001.3001-3004. Capome 1mm watt Canpany 40 4. Maria! Breach. A material breach ofthis CIA means: a. a torepoit aRepoitnbieEvent, take corrective action and pay the appropriate i'e?inds. as provided in section um, provided that any ofthe following individuals at HCA had notice of the Reportable Event: an emcee; a director; a Responsible EXecutive; an a member ofthe EC Department; or an ottomey in the Logai Department; 1). repeated or ?agrant violations of the obligations under this CIA, including, but notlimited to, the obligations addressed in section X.A ofthis c. a ?ailure to respond to 3 Demand Letter concerning the payment of Stipulated Penalties in accordance with section X3 above; or d. for review purposes in mordmoewith section 111D. D- 1. Review Rights. Upon the 016?s deliveryto HCA of its Demand Letter or of its Exclusion letter, and as an agreed-upon contractual remedy for the resolution of disputes arising under the obligation ofthis 'ciA, HCA shall be a?'orded certain leview rights comparable to the ones that are provided in 42 U.S.C. 13203.76) and 42 CPR. Part 1005 as if they applied to the Stipulated Penalties or exclusion sought pursuant to RCA?TheHeaIthmtoCompany 4i this CIA. Speci?cally, the 010?s determination to demand payment of Stipulatcd Penalties or to seek exclusion shall be subject to review by an ALJ and, in the event ofan appeaLtheDeparhnentalAppeals inamannerconsistentwith?ie provisions in 42 CPR. 10052-100521. Notwithstanding the language in 42 CPR. the request for shearing involving stipulated penalties shall be made within 10 days of HCA receiving the Demand Letter and the request for a hearing involving exclusion shall be made within 20 days of HCA receiving the Exclusion Letter. 2. Stpukrted Penalties Review. Notwithstanding any provision of Title 42 of the United States Code or Chapter 42 of the Code of Federal Regulations, the only issues in a proceeding for stipulated penalties under this CIA shall he: whether HCA was in full and timely compliance with the obligations ofthis CIA for which the 016 demands payment; and the period of nmoomp?ance. l-lCA shall have the burden of proving its full and timely compliance and the steps taken to cure the noncompliance, if any. If the ALJ ?nds for the 016 with regard to a ?nding ofa breach of this CIA and orders HCA to pay Stipulated Penalties, such Stipulated Penalties shall become due and payable 20 days use: the issues such a decision notwithstanding that HCA may request review of the decision by the DAB. 3. Exchuian Review. Notwithstanding any provision of Title 42 of the United States Code or Chapter 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breech of this CIA shall he: whether Comte main! Aswan RCA - The Healthcarc Company 42 HCA in material breach ofthis on; Whether such breach was continuing on the date of the Exclusion Letter; and whether the alleged material breach could not have been curedwithin the 30-day period, hutthat?) begun totnke action to curethe material breach within that period, (ii) HCAhas pursued and is pursuing such action with due diligence, and HCA provided to 016 within that period a reasonable timetable for mining the material breach. For purposes ofthe circlusion herein, exclusion shall take effect only after an ALJ decision that is favorable to the OIG. election of its contractual right to appeal to the DAB shall not abrogate the 016?s authority to exclude HCA and/or any of its subsidiaries upon the issuance of the decision. If theALJ sustains the determination of the 016 and determines that exclusion is authorized, such exclusion shall take e??ect 20 days after the ALJ issues such a decision. notwithstanding that HCA may request review of the ALI decision by the DAB. Consistent with the provisions in the Settlement Agreement pursuant to which this CIA is emailed, and into which this CIA is incorporated, HCA and OIG agree as follows: A. This CIA shall be binding on the successors, assigns, and transferees consistent with the terms or'Section 1v; . B. This CIA shall become ?nal and binding on the datethatthe court(s) acoeptthe plea(s) and impose a sentence in the criminal proceedings related to the plea agreement CorpmtelnteyityAgreanent 43 entered into between HCA and the United States on or the date of the signing of this C. Any modi?ca?onsto?lis CIAshallbemadewiththepzim-wrim consentof the parties to this and D. The undersing HCA signatories reprwent and warrant that they are authorized to execute this CIA. The undexsimed OIG signatory represents that he is signing this CIA in his omcial eapacity and that he is authorized to execute this CIA. Capos-ate lnteyity Agnement RCA - The Heathen: Company 44 ON BEHALF OF HCA . ?(lion Thomas F. Frist, 31:, MD DATE Chairman and Chief Execuh O?eer HCA - The Company tar/loo) 9? DATE 41 we, Alan Yuspe? Senior Vice President . Ethics, Compliance, and Corporate Responsibility HCA - The Healthcare Company ON BEHALF or Omen or INSPECTOR GENERAL or DEPARTMENT or HEALTH AND HUMAN SERVICES Lewis Morris DATE Assistant Inspector General for Legal A?'aizs O?ioe of Inspector General . U. S. Department ofHeaIth and Human Services Corporate Integrin ligament HCA - The Healthcare Camping! 45 A abut-w ?1:552: ?lm 7 {-334 ON BEHALF OF HCA Thomas F. Exist, In, MD DATE Chairman and Chief Executive Of?cer HCA The Healthcare Company Alan Yuspeh DATE Senior; Vice President Ethics. Compliance. and Corporate Responsibility HCA - The Healthcare Company 2 i ON 323m arm omen or INSPECTOR cm or DEPARTMENT or HUMAN SERVICES My?" /2 agape) Lewis Morris DA Assiswit Inspector Genexal for Legal A?ixs Of?ce of Inspecmr General U. S. Dcpaxtxnent of Health and Human Services Corporate Integrity Antwan HCA a The Halibut: Company 45 APPENDIXB - 1:193: lease coagulate and ?n to Commuter. :indlar daamem attaining the following ity'amation, should accompany ever re?md so that receipt cheat is properly recorded and applied. - I ROVIDERIPHYSICIANISUPPLIBRNAMB '1 DRESS CHECK ONTACT PERSON: PHONE AMOUNT OF CHECK 1' LU. 14m Ll! - ClaimAmoumRemnded nCodeforClaimAdjusuncnt: (Selectteamncode?omlistbelow. Useonereaso -u ole?n) Comma [Meg-Ry Amt HCA - The Healthm Company 46 (Plea: (is: an data involved; Attach separate sheet, ifnammy) . ate: lfspecb?ic Paar/madam #lCtaim Ammonium not availablefor all claims due to 511111de mailing. please indicate methodology aldfommla used to determine . amount and reason for ovapaym: 3" a Reportha?s) . streportyear.) Vu U. Lia: L?iu'b ymha'vea AgeementwithOIGLawt..-? Adz: ij?iur Let-:1; :uv - mm lB-Wcimbocumm?on -anlicaxe 14-min:th t: lO-MSth??yInsurance lS-SchieesNot .. -qupa?cma) - MSP. 16 -Medical Necessity -Modi?etAddedIRmoved Blanking l?l-OxbacPleaSeSpecify) -B?ledinEnor lZ-chAdminim?on Comm-ate Integrity Amen: Company 47 APPENDIX A HCA Corporate [integrity Agreement A. W. l. Dejbii?ons. a. desaibedintheClerthewoerlans that involves the review of bills, claims, or other submissions to any Federal health can program. b. W: A statis?cally valid, randomly selected, sample of items selected for appraisal in 21 Claims Review. c: In: Any ?neimbene?ciaiy, patit etc.). d. Consistent with the de?nition of Oval-payment in section [3111.21 ofthe CIA, the amount of money HCA has received in excess of the . amount due and payable under any Federal health cane program reqmiements. For the purposes of the workplans. any Claims Reviews, and all reporting to the 016 nndet this CIA, shall not subtract or ?act out? undeapayments when determining the amount of relevant Overpayments. e. thetotal amount of overpayments divided by the total payment onnts received under Federal health care programs for the sample Items reviewed. mm: A code or line item submitted by and for which HCA has received reimbmsement from the Medicare program. g. m: All lm for which HCA has submitted aeode or line item and Paid Claim) dining the one year period covered by the Claims Review, unless a Tobeineltaiedinthe Population, in Item must haveresulted inat least onePaicl Claim" h. We: ofltems selected through random sampling ?om the Population. The Probe Sample may Integrity Azteement: HCA - The Healtheare Company 1 aFall Sampleorforthepurpose the Population (to calculatetheminimmnnumber ofltetns to be included in the Full Sample), or both. If the reatlts from the pxobe sample already achieve the statistical con?dence and precision parameters set ?oth in this Appendix A, then the Probe Sample results can be used as the Full Sample resins and another mplewinnotbereqtired. i. m: A Claims Review Sample ?'om which an ovetpayment amount j. 016?s O?ce of Audit Services Statistical Sampling Software. RAT-STATS is publicly available to download through the Intemet at 2. Baa-@601: ofaaims ReviewMethdalag. Each Claims Review shall be conducted in the manner set forth in the applicable wodcplans consistent with the CIA and this AppendixA. a- W- Whenever a sample of anything. eat. claims. bene?ciaties, howitals, is selected pin-want to the CIA orthe workplans, the ample shall be selected through the use ofthe RAT-STATS ?Random Numbers" functionTotheextentthata I lan requires a Full Sample, it mu meet the folio requirements (or altanatively, the full univetse of Items may be reviewed). The Full Sample must contain a su?eient number ofItems so that if the Overpayments identi?ed in the Full Sample were projected to the Population, the projection would provide a 90% con?dence level and a maxim relative precision (Ls, semi-width ofthe con?dence interval) of plus or minus 25% of the point estimate. In other words, if the Full Santple Overpayment results wen: projected to the Population at a 90% con?dence level, the con?dence intu'val (aqmmd in dollars) must be sn?eiently mow that the upper bound of the con?dence interval would not exceed 125% ofthe midpoint of thecon?dence interval (the point estimate). and the lure? bound ofthe con?dence interval would not be less than 75% of the midpoint of the con?dence interval. 1). C. -it- - Pan-:14: .I .1 1. . 3V-- Pnobe etennine whetherto conduct ateview of aFnll Sample, the detexmination shall be based upon the Gross Financial Error Appendix A to CM Integrity Await: HCA-?lhe Healtheare Company 2 Sample. Tothe mmata?naneial enorthreshold (sushas 5%)isusedforsampleexpansion, onotbermatters(suehas ?unpalationof ovetpayments). Nothing inthe CIA, this Appendix A, orthe wonkplans telieves Samplelsusedtodeteunine?tesamp following clitetia. The Probe Sample shall include a random sample ofat least 50 Items. Sample have been reviewed, the estimated mean and standard deviation of the Populationshallhedetennined. This domination isbasedontheOvetpayment function standard deviation cf the Population. For pmposes of eatimating the mean and standarddeviation ofthe Popuh?omandentering this information into the ?Variable Appraisals? function of RAT-STATS, any underpayment idmti?ed for overpayment. Ifno are found inthe Pmbe Samplethen the Claims Review can be oftheProbe Sampleahall berepmtedin lieu ofthe Claims Review of theFull Sample. 3591! 2 my 111? .1 Th: of the mean and the standaxd deviation of the Population obtained dnuughthe review ofthe Probe Sampleshall be used to mladatethe minimum size oftheFull Sample. In orderto detexminethe minilmun number ofltems that must be included in the Full Sample to meet the 90% eon?deme level and 25% precision tequiremems, RAT-STATS ?Sample Size Estimators? (located under the ?Utility ngrams" ?le) shall be used. The Full Sample shall bea random sample hunt the entire Population, with the Papulation including those Items lteznsinthePopulationbavean Sample. f. Sampleora Full Sample), only Paid Claims shall be evaluated Event Paid Claim in the daimsReviewSampleshallhe evaluatedto detaminewhediertheolaim is, 8. Wheneva'a-Probe - . . HOA-?l?heliealtbeamCompany 3 Paid ClaimforwhichHCA considered an error and the reimbursement!de by HCA forth: unsupported por?onofsuchl?aid Replacement h- M?mm In ofherwadgitisnotpennissiblcto B. l. WW}!thng a. achieved bythe ClaimsReview. b. Adescription isrr?lizedformeClaims Review. c. A description of the Population subject to the d. W: Adescrip?onofthesamp?ng?ame. whichisthetoralityof explanation ofthe methodology used to identify the W533 ?ame. In most circumstances, ?xesampling ?amewillbeiden?caltothe Population. e. W: ceui?cates ofmedica! necessity, requisition fang-local medical review policies. HCFA program maxim-ands, Medicare canister intermediary manual or bulletins, o?ncrpoiictes, regula?om. f. AppendkAtoComomlmy?yAmut RCA?mammoompmy 4 2. a. The number ofltems appraised intberbe Samples and inthoPull Samples. b. A copy oftbe RAT-STAB minions ofthe random mmbers generated by the ?Random ?mction. c. A copy of the RAT-STATS pxintouts of the ?Sample Size ?tlmators? results Samples. d. A copy of the RAT-STATS printom of the ?Variable Appraisals? ?metion results in: the Pmbe Samples. e. availablototbeOlGuponrequest. 3. a. inwhichitwas determinedthat the Paid Claim submitted by HCA (?Claim Submitted?) di??ered from what should have beenthe comet claim C?Correct Claim"). regardless ofthe e?'ect on the payment b. Total numberandpereento'ge atom inwhichthe Claim Submitted di?esed?'omtheConect Overpayment to RCA. c. The total dollar amount of all Paid Claims in the Claims Review Sample and the total dollar amoum of Oveipaymenm associated with the Paid Claims identi?ed by the Claims Review. (This is the total dollar amount of the Ovexpaymeols identi?ed in section 3.3.1) above.) 6. Fedeml healthcareprogmmbilled. (See AmnhmaulmthisAppendix.) AppeodbtA to Capone: busily Amen: RCA - The Realm Company 5 4. Credentials Themes andcredm?als designedthe Reviev?vs; andCZ) petfonned the Claims Mews. 6 RCA?mummy? Claim Review Results Federal Bone Date of Procedure Procedure Allowed Correct Com Dollar Di??erenee Health Care HIC i! Service Code Code Amount Procedure Allowed Amt betweenAmt Brogram Submitted Reimbursed Reimbursed Code ([110 (1110 Wet! and Billed determined) determined) Correct Allowed Amt Attachment to Appeadht A RCA Corporate Integrity Agreement This workplan describes the review procedures thatHCA?The Healthcare Company (the - codingprocesses. The?ocns ofthis testing will he to investigate outliers identi?ed through a benchmarking process of certain Medicare inpatient DRG ratios. In addition, theIRO will obtain an understanding of the Company?s processes and controls that are designed to prevent and detect Federally funded payor inpatient DRG coding errors. memo and asappropriateto record level DRG validation testing. The ?icus ofthe procedures will be on the Company?s acute care hospitals? processes and controls designed to ensure compliance with DRG coding requirements. The RC will begin its understanding of the Company?s DRG coding compliance by understanding the process performed at the Corporate level. The focus will be On the Contpany?s controls a??eeling the entire aaltecarehospital system. A?a'gainingthis understanding, the IRO and the Company will desim ageed upon procedtnes which will allow the Company and the 016 to evaluate the e?'ectiveness of the Corporate ComplianceRiskManagement Process. 'l?hekeystepstheIROwill followto gain an understanding of the corporate compliance control environment include the following: The RC will obtain an raiders-landing of the regulatory environment, of key assumptions underlying DRG coding processes and the impact of changes on potential Company. Procedmeswill include: 1. Interview the Corporate Ethics and Compliance'Of?cer, SVP Government Programs, Health Information Management Services (HIMS) VP and other key personnel to: DRG l-lCA Corporate Integrity Agreement ?@133 l-lCA Cot-pom: Inteaity Agent-mt 3. Understand howtheCompmy evaluatesriskandchangesinthe compliance environment. b. Understand how these changes become integrated into the overall compliance strategy. c. Understand how these changes are implemented in the acute care hospitals. 2. Read related documentation such as w?ritten assessments ofchanges in regulations. The IRO will understand how the Company establishes the DRG coding policies and procedures by performing the following procedures: 1. Read organizational charts to understand compliance in?'aslructure. 2. Read policy and procedure manuals and other tools and resources and compare to regulatory reqt?rements. 3. Understand how the Federally ?mded inpatient DRG coding policies and procedures are established by interviewing the Corporate Ethics and Compliance O?cer, SVP Government Programs, HIMS VP and other key personnel. 4. Read the Company?s doctnnemation regarding the process for creating, updating and distributing the policies and procedures. The RC will understand how the Company ensures that DRG Coding personnel have the appropriate training and expertise to implement risk control processes by performing the following procedures: 1. Interview key personnel regarding the design and implementation of education and training processes. . 2. Read training materials at the corporate and facility levels and ?impure to Commny policies for content 3. Select a random sample coding personnel and determine ifn-aining requirements are being met. The RO will tmdasmnd how the Company measures, monitors and assesses the performance of the compliance process by performing the following procedures: 1. lnquireas to the types ofmonitoring tools and plans'that are inplace toprevent and detect non-compliance. 2. Understand and observe techniques utilized by the Company in identifying outliers for subsequent testing. 3. Read a random sample of interim monitoring reports. 4. Review a random sample of implementation plans for process improvemmts and error correction. 5. Read the ?ndings of a random sample of the Company DRG coding reviews. The will identify the electronic data processing systems that are used to process data relevant to the DRG coding practices. The RO shall gain an understanding ofthe control over these systems related to: 1. Access to critical data. 2. Security over data and critical applications. 3. Application and prom-am change controls. DRG Wortplan RCA Corporate Integrity Agreement 3 hawtheCompany?sprocedmesfor ensuringthatncn- . compliance within the DRG coding process is addressed by performing the following procedures: 1. Interview regardingtheprocess forreportingerrorsandcreathig actionplans. 2. Determine that action plans were prepared and select arandom sample of 5 actionle andincorpor?eintothe design ofdetailedtestingprocedmes. 3. Read the Company?s recommendations for process improvements to prevent potential ?rture non-compliance and integrate into the design of detailed tests. The Company and mo will perform coding engagement procedures upon completion of the Corporate level process testing as ?lm: DRG Workplan l-lCA Corporate integrity Agreement WW 1. The Company will benchmark its acute care hospitals' Medicare inpatient DRGs against industry peer groups for 17 Medicare Inpatient DRG ratios the immediately preceding calendar year each January. The DRG ratios to be benchmarked will be ageed upon by the 016 and the Company at the end of each calendar year. Unless the 016 noti?es the Company otherwise, the Company will bonehmark the 17 Medicare DRG ratios listed in Attachinent A. (Ifthe Company proposes to mend the list ratios to he bendimarked, it shall provide notice to the 016 ofthe propoSed DRG ratios at least 90 days before the end of the calendar year.) The be per?mned as follows: a. Each January, the most recently available MedPar data. comprised of all non-HCA hospitals, will be used to determine DRG ratio benchmarksandcasecomts. A. one Workplan b. Thede?nition ofnon-HCA acute carehospitals whichwillbe used to determine the non-HCA Medicare DRG ratios is those acute care hoaritals that the Company did not own during the timed-clue that is represented in theMedPardatabeingused. Forexarnple, ifanacute carehospitalhad been 1999 butwas sold during2000,thisaeute carehospital wouldbeincluded as acntecarehospital and excluded as anon-RCA acute care hospital for the benchmarks that are based on War 1999 data. c. Bach January, internal Company data ?ow the twelve months ofthejtst- completed calendar year will be used to determine the acute care hospitals' ratios and the case counts used in the benchmarking process. (1. The industry Medicare DRG ratio benchmarks will be calculated as the national 75" percentile. e. Each acute care hospital?s Medicare DRG ratio results will be compared to the industry Medicare DRG ratio benchmarks and those Medicare DRG ratio results in excess of the industry Medicare DRG redo benchmark will be identi?ed. f. For each of the 17 DRGs in the numerator of a DRG ratio, the Mom] 90? percentile ofcase counts for non-HCA acute care hospitals will be determined using MedPar data. g. For each of the Medicare DRG ratios over the benchmark identi?ed in section at a particular acute care hospital, itwill be detennined if the case count for that DRG at that acute care hospital is at or above the national 90" percentile ofcase counts for that DRG among non-HCA hospitals. in Subject to the following provisions, an acute care hospital shall be identi?ed for further review iflt has at least 2 of the 17 DRG ratios over the industry benchmark and the case count for these DRGs is at or above the national 90" percentile of case coums for that DRG among non-HCA hospitals. RCA Corporate mica-?y Agreement 5 i. The hospitals that meet the criteriain section Ill.A.l.h shall be ranked based on the number of ?priruary" (non-cc) DRG ratios that are over the industry benchmark atthat hospiml, regardless ofthecase counts for these DRGs, ahospttal thathas 4 primary DRGratios overthe industry DRG ratios oVer the industry benchmark. j. The 20 highest ranked hospitals shall be selected forDRG review. If fewerthanZOhospitals arerank?thenalloftheranked homitalswillbe selected for review. Iffewer than 16 hospitals are ranked, then the highest ranked hospitals will be reviewed along with the malted hospitals with the highest'case counts of DRGs above the industry benchmarks in order to ensurethatatleast 16hOSpitalsarereviewed. lnnoeventshall 16 hospitals be reviewed. k. The hospitals to be reviewed under'this analysis shall be reviewed over the four quarters of the calendar year. 2. The mo will verify that current Company data is the source for establishing the Company?s Medicare DRG ratios-thatWill be benchmarked. 3. The IRO will verify that the mostrecentMedPar dataas described in section 111A. l.a-b, comprised of all non-RCA acute care hospitals is the source for establishing industry Medicare DRG ratio benchmarks and case counts and will annually recompute the industry peer group Medicare DRG ratio benchmarks and case counts utilized by the Company. 4. Each February (or the month a?er any benchmarking takes place), the mo will obtain current Company data and recalculate benchmarking on a random sample of at last 10% of the Company?s hospitals. For ample, if the number of acute care hospitals owned was 220, a minimum of22 acute care hoSpitals Medicare DRG rau?o results would be reviewed (220 acute care hospitals 10% 22 acute care hospitatsto be tested). DRG Workplan HCA Corporate lntegity Agreement 6 I. For those hospitals selected for review in section above, the Company will perform a DRG Claims Review of a Full Sample (as described 'in Appendix A to the CIA) of the higher weighted DRG for each DRG ratio above the benchmark. Forthepmpose ofa Claims Review underthis auditworkplan, theItems tobe reviewed shall bethepald inpatientMedicarebills fortheDRGs inquestlon. The Claims of each Item shall include an independent code validation ofthe medical record to assess the acmcy of the diagnosis and procedure codes, ?nancial class. discharge sex. age. and DRG assignment. The from the rolling 12-month period irnmodiately preceding the Claims Review. 2. Its Probe Sample is conducted pursuant to Appendix A and that Probe Sample forth inAppendifoorFull Santples,?g?the 90% con?dence level and 25% precision requirements, then the Company may treat the Probe Sarnple as the Full Sample for that DRG. Wherever a DRG Claims Review of a Full Sample is required, the Company may choose to review 100% of the claims in the universe ratherthan selecting a sample.- 3. The 1110 will verify the bendtmarking approach, 5g? acute care hospitals identi?ed, ease counts, subsequent review methodology (probe or universe) and the Company?s Medicare DRG Claims Review results. 4. The IRO will select arandom sample of at least 10% of the medical records included in the Medicare DRG Claims Reviews puformed by the Company and re-perform the Company?s workplan steps. Findings will be summarized in the 1110?s Report. For example, if the Company reviewed 20,000 ?les, the would reperfm'm reviews of 10% or 2,000 ?les. l. The Company will annually complete and maintain a DRG risk and controls pro?le for each amte care hospital. The pro?lewill contain indicators including: DRG Workplan HCA Corporate Integrity Ageement 1 0 Number of Medicare outlier DRGs - Acctn'acy results of Federal health care program inpatient DRG coding reviews Percentage increase in Medicare Case Mix index Percentage of Medicare complications and co-morhidities Implementation of Company Coding Policies and Procedures 'Iiunover of certain hospital management and coding personnel Existence ofintemal quality assessment monitoring pray-am Coding sta?' ful?llment of continuing education requirements (See Mchment for the DRG Risk and Controls Pro?le.) 2. Based on the results ofstep the Company will gain an understanding of the-acute care hospital?s compliance and control environment and identify the ?higher? risk acute care hOSpitals for further detailed process and controls testing based on the risk score determined using the pro?les. The pro?le will consist of a series of indicators that will be assigned points. Each ofthe criteria in the risk and controls promo will beworth a certain number ofpoints as indicated in B. 3. At a minimmn, the Company will annually test (as outlined in sections N3 and C, below) a minimum of 10% of its acute tare hospitals or 22 hospitals, whicheveris greater, (but inno eventshall the Company berequired to test more than 15% of its acute care hospitals annually under this provision) that will include at least 2/3 ?higher risk? acute care hospitals and 1/3 randomly selected ?lower risk? acute care hospitals. a. The acute care hospitals with the lowest scores ?'om the risk pro?ling dwerihed in step 2, other than those acute care hospitals tested in step RIB above will he considered ?higher risk." b. The ?lower risk? acute care hospitals will be a random selection of the remaining acute care hospitals not selected in step above and not tested in step m3. 4. The mo will: a. Read the Company?s DRG risk and controls pro?les. mic RCA CapamWoAsreanmt 8 b. Compare the information contained in this pro?le for arandom sample ofat least 10% ofthe Company?s acute care haspitals to somee documents and recompute their overall risk score. For example, if the Company owned 220 acute care hospitals, this would include a minimum of 22 acute care hospitals. c. Compare the Company?s identi?cation ofthe ?higher? risk acute care computed risk score. 5. For-the acute care hospitals selected fordetailed review in steps NAJ through 3 above, steps N3 and C, outlined below, will 6. The hospitals to be reviewed under this analysis shall be reviewed over the four quarters of the calendar year. l. The Company will obtain an understanding of the compliance controls and the Federal health care programs inpatient DRG Coding 9mm operating at each acute care hospital identi?ed in section IVA by performing the following procedures: a. Interview acute care hospital personnel. b. Read documentation at the acute care hospital level that supports the DRG coding process. c. Observe the use of varimts tools and materials provided to the acute care hospitals ?om Corporate. d. Determine if coding training requirements are being met for acute care hospital inpatient DRG coding personnel. e. Docmnent the process and signi?cant control points in the workpapers. 2. The Company will compare the process at each acute care hospital identi?ed in section NM process to the model process from Corporate (reviewed in Section DRG RCA Corporate integrity Agrecm cut 9 11 above) and identify any control gaps or points within the processes for the seine care hospitals selected that may result in non-compliance. Where primary controls are not properly implemented as outlined inthe model process from Coqmrate, the Cmpanywill review documentationto determine ifany secondary controls exist toreducetherlsk ofinaccurateFederal health careprogram assigment 3. The Company will perform procedures for the acute care hospitals identi?ed in sectionIVAs abovethat focus identi?ed in step IV.B.2. Procedures will include inquiry, observation of process steps, and testing of supporting information relating to the following: 3. Controls regarding the physician documentation in the inpatient medical record. I). Inpatient medical record completion. c. Encoder use for DRG assignment. d. Code editing and submission on Federal health care program inpatient DRGs. 4. The IRO will: a. Read all documentation prepared by the Company in steps NB. 1-3 above. b. Jointly perform the steps above for a? random selection of at least 10% of the acute care hospitals to he tested. For example, if the Company tested 22 acute care hospitals, the mo would jointly perform testing at 3 of the acute care hospitals. 0. Perform the Company?s wodqllan steps on arandorn sample selected by theIRO ofatleast10% oftheacutecarehospitalsto hetested. For errantple, ifthe Company tested 22 acute care hospitals, the mo would perform testing at 3 of the acute care hospitals. nae Workplan HCA Corporate Integrity Agreement to The Company will test the controls ?n the Company?s acute care hospitals as identi?ed in step IVA to determine if the controls are operating e?'ectively' to reduce the compliance risk associated with the Federal health care program DRG The Company will review a sample ofFederal health care overall controls attheacute care hospitals selected in step IVA for testingas follows: 1. The Company will perform a Claim Review of a Probe Sample of at least 30 inpatient Federal health care programka bill (Item) horn ?te rolling 12-month period immediately preceding the review at each selected acute care hospital. The Claims Retriew of each Item shall include an independent code validation ofthe medical record to assess the accuracy of the diagnosis and procedure codes, ?nancial class, discharge disposition, sex, age, and DRG assignment. Based onthe results of this testing, the Company will determine whether a Claims Review of a Full Sample is required as follows: a. Ifthe Probe Sample results indicate a gross ?nancial error rate of less than no further testing will be performed. b. If the Probe Sample results indicate a gross ?nancial error rate of 5% or more, the Company will conduct a Claims Review of a Full Sample of Federal health care program DRG claims from the CIA year at each acute care hospital in accordance with Appendix A. 2. The IRO will: a. Read the Company?s documentation regarding the review results and determine whether the appropriate reviews, including Probe Sample and Full Sample Claims Reviews, were performed based on the criteria outlined above, the CIA, and AppendixA. b. Select a random sample of at least 10% of the acute care hospitals reviewed by the Company in section IV.C and reperfom the testing described above. DRG Workplan HQACcrporatelntegrity Agreement ll 0. Perform testing on the acute carehospitals the mo reviewed in section NB. (1. Read the documentation of the DRG Claims Reviews noting completion of all workplan steps. e. Recompute a random sample of the emapolations oferror rates resulting ?'om the Claims Reviews ofFull Samples performed by Company. Notwithstanding the other provisions ofthis wra'kplan, the Company may choose to conduct the reviews in the ?rst year after the e?'ective date of the CIA in the following manner. A. The quarterly reviews shall cover Items related to the time period ?om January 1, 2001, to the date ofthe review (rather-than always relating to the am pmeedhig 12-month time period as is required in other years). B. At least 25% ofeach type of review conducted those conducted pursuant to section and those conducted pursuant to section 1V) shall cover the preceding 12-month period. C. At least 25% of each type of review conducted those conducted pursuant to section 111 and those ?inducted pursuant to section IV) shall cover the preceding 9-month period. D. The remaining reviews (those not described in sections VB and above) shall include the preceding 6-month period. The Company and the mo will ensure that information about which acute care hospitals are snbjecttoreview underthisworkplan will tapersonncl attheacute care hospitals until notice is necessary to make arrangements to conduct oat-site review processes required in the work plan, but in no event earlier than foulweeks prior to commencement ofsneh review. has HCA Corporate integrity Amour l2 V?o Upon completion of all testing of process controls, Medicare bchmarlting and testing of Federal health care program DRG cod'mg engagement procedures, the Company will quantify the results and ?ndings and will report to? the 016. The Company?s report will include the following: A. The infonne?onrequiredforthe ClaimsReviewRepottinAppendixA. Claims Review Objective Sampling Unit: DRG Claims Review Population Sampling Frame Sources ofDatn Review Protocol Statistical Sampling Documentation Claims Review Results Credentials B. The results of testing the Company?s Federal health care program inpatient DRG coding operations (including, but not limited to, the operation of the coding system, andweaknesses of the system, internal controls, effectiveness the system). - C. The Company?s procedures to correct inaccurate assigmnentor reporting to Federal health care programs. D. The steps the Company is taking to bring its operations into compliance or to correct problems identi?ed by any ofthe reviews described above. The lROwill read the Company?s results and ?ndings reported to the 016 and issue a report that enumerates the procedtnes performed and the ?ndings for each procedure. The IRO will report the results of all reperfonned work required in the DRG Work Plan. for improvement of Company practices. DRG Workplan RCA Cor-potato Integrity Agrecmmt 13 HCA . DRG 17 Medicare DRG Ratios to be in Year One 1'6 82 Pn'miy Medicare DRG 79 39 Primny Mcdicuie DRG 37 as, 121 371(37+ss+127) Primary mam one 39 9o 391(39+903 cc Medicaic DRG 121 11?. cc Medic-ac DRG 124 125. mlazium cc Mcdicarc DRG 132 140. 143 1321(132+14o+143) Primary Medicare DRG 133 139 iasi(133+139) cc Medicareka 143 149 cc Medicacc DRG 175 cc Medicare DRG 132 133 133) cc Mcdicace DRG 197 193 19iia97+193) cc Medicare DRG 210 211 210K210 +211) cc Mcdicarc DRG 295 297 29610964497) cc Mcciicarc DRG 316 127 Primary Medicare DRG 415 320, 277 4 Primary Medieacc DRG 475 (Total cues for all Mcdicacc mag) 475mm Medicarc Discharges Primary Medium DRG A to DRG workplan HCA CIA l. The results of the Benchmarking of Medicare DRG ratios perforated in section of the workplan, rating no case eormt thresholds, will be facilities. Scores will be awarded based on the number of times a hospital?s DRG ratios are over the ?cm?iers?) as follows: 10 ?more outliers Opoints 9 outliers '3 points 8 outliers 6 points 7 outliers 9 points 6 outliers 12 points 5 outliers 15 points 4 outliers 17 points 3 outliers 19 points 2 outliers 21 points 1 outliers 23 points 0 mnliers 25 points The results of the most recently performed Medicare, Medicaid, and/or Inpatient DRG accuracy reviews relating-to coding will be used to award points based on the of accuracy achieved are as follows: 1W 98% orbetter 30 points 959?o-97% 20 points 10 points 8696-8996 Opoints -5 points Less than 80% -10 points DRG Risk Pro?le (Went to DRG workplan) HCA Corporate Inmgity Amen 93 ?1 u. '15. kw ml A hospital will receive 15 1105116 ifthe percent increase in the Medicare Case Mix Index, compared to the prior year, is less than the mean plus 1 standard deviation. The hospital will receiveOpoints ifthepercentincreaseinthe Medicare CaseMix Index. compared to the prioryear, is geaterthan the mean plus 1 standard deviation. (NOTE: the mean and standard deviation will be calculated usingthe hospital?s most recent 8 quarters Medicare Case Mix Index results.) - A hospital will receive 20 points iftheir Medicare is below die National 75" percentile. The hospital will receive 0 points if their Medicare is above the National 75? percentile. 5. The Hospital will lose 2 points for each of the following policies that it has not implemented. HIM COD 00! - Coding Documentation Policy for Inpatient Services HIM COD 003 - Coding References and Tools HIM COD 004 - Coding Help Line HIM COD 005 - Coding Orientation and Training HIM COD 006 - Coding Continuing Education Requirements 6. my. . the prior year. CEO CFO ECO Coding. Manager/Lead Coder HIMS Director Inpatimt Coders . DRG Risk Pro?le (attachment to DRG workmen) HCA Corporate Inteyity Amen: Deductions will be made for turnover in the following positions over -2 points -2 points -2 points -5 points -5 points --5 points (up to a maximum of 15 points) 7. 10poimswillbeaddedifthehospimi an internal quality assessment monitoring program'for coding accuracy and productivity in place. (This would also include quality assessment monitoring outsourced to external vmdors sub-contacted by the hospital, but not Corporate HIMS.) 8. Deduct points based oaths paoentage of the hospital?s inpa?entooding sta??thathas matheir 30 hours of continuing education and other training requirements dining the prior year. 81-85% .3 75-80% -10 75% or less ~15 momma DRG Risk mm: (Moo: 8 to DRG wanna) RCA Comm Wily Agreement 3 HCA - The Healthcare Comm. OWAIENTLABORATORY WORKPLAN I. INTRODUCTION This describes the review process that HCA The Healthcare Company (the ?Company?) and the hdepardent Review Orgnization will follow with respect to testing the Company?s Outpatient Laboratory billing process rdated to Medicare, Medicaid and other federally funded payers. The IRO will pin an understanding of the Company?s processes and controls that are designed to prevent and detect billing errors. The Company andIRO will use their understanding of processes and controls to select which hospitals to review in detail. The focus of the procedures will be on the company and hospitals? processes and controls designed to ensure compliance with Ounpatient Laboratory billing requirements. 11. OUTPATIENT LABORATORY BILLING CORPORATE COMPLIANCE PROCESS The will begin its understanding of the Company?s Outpatient Laboratory billing compliance by understanding the process performed at the Corporate level. The focus will be onthe Company's controls a?-?ecting the hospitals. After gaining this understanding, the mo and the Company will design agreed upon procedures which will allow the Company and the 016 to evaluate the e??ectivens of the Corporate Compliance ln?'astructurc. Focusing on the Company?s in?astructure, processes, controls, and monitoring systems, the R0 will: A. Understand Outpatient Laboratory Billing Compliance Process The IRO will understand the Company Outpatient Laboratory Billing Compliance Plan C?Plan?) which is based on the 016?s Clinical Laboratory Compliance Frog-am Guidance (OIG-CPG). The following interviews/reviews will be performed to understand the implementation of the Plan designed to mitigte risk and achieve compliance: 1. Read organizational charts andunderstand outpatient laboratory billing compliance in?astructure. 2. Interview the Corporate Ethics and Compliance O?cer, VP Governmental Operations Support (608) and other lacy personnel to: Understand the strategy and process used to create the Plan. Understand the process used to review and revise the Plan. including laboratory billing policies and procedures. 3. Compare the me. to the ore-ore, identi? variations and determine ifthese variations have a signi?cant impact on compliance. 4. Understand the process used to implement changes and revisions to the Plan and how they are communicatedto the hospimls. 5. Read training plans developed at corporate level and understand how they are implemented at the hospital level. Identify critical areas not covered by such warning. 6. Understand the use and role of the corporate preferred electronic billing vendor and corporate de?ned edits through'discussions with 608 VP, Director, Monitoring and other key personnel. B. Review Outpatient Laboratory Billing Compliance Plan Controls The 1110 will understand how the Company ensures that controls are in place that support the Plan in order to reduce compliance risk, identify laboratory over-payments, and repay the appropriate payors. Procedures to gain this understanding include: 1. Compare the Company suite of electronic billing vendor edits to 60$ outpatient laboratory policies which incorporate regulatory requirements. Check for validity of all codes and identify variances. 2. Read and/or observe the Company?s quality control process for established electronic billing vendor edits and determine if any de?ned edits referencedin Section B. . above are missing or not operating correctly. 3. Understand the process of accessing and revising the application and maintenance of the Company?s standardized Laboratory chargemaster and the process quali?ed personnel use to access and update-the chargernaster. 4. Review the results of the assessment performed by an external review organization of the Company?s standardized Laboratory chargernaster. 5. Reed selected training programs and related materials to assess implementation and consistency with regulations. 6. Select a sample of 10 hospitals Earn the corporate compliance training database and test for hospital attendance/participmion. 7. Understand the Company?s e?'orts to keep abreast ofnew federal laboratory billing rules and changes and understand how the Company informs its hospitals to conform their billing processes and controls to such a change(s). 8. and requirements have been incorporated into (308 outpatient laboratory billing policies. . c. Understand Outpatient inner-story Billing Compliance Monitoring Function . The 1R0 will understand how the Company measures. monitors and assesses the performance of the compliance process through the mllowms procedmes: 1. Interview the Corporate Ethics and Compliance Of?cer, 603 and other key personnel. 2. ofmonitoringplans, prevent and detect non-compliance. 3. Review a represemative sample of 10 results of monitoring activities ?'om 10 hospitals, including corrective action plans. Compare the action taken to appropriate, billing rules and regulations and identify any non-conformance. 4. Compare-le tools, and reports to rules, regulations and policies, identify variances and make recommendations for additional tools to facilitate monitoring activities. I). Summarize the Outpatient Laboratory Billing Compliance Process ThelROwill ?'omsectionsllAtlnoughC outlined above to allow the 016 and the Company to evaluate the following: 1. Whether the established outpatient laboratory infrastructure is success?illy designed to comply with relevant regulations. 2. Whether the Company's existing processes, controls and monitoring activities address major areas of outpatient laboratory compliance risk. 3. Whether level. 4. The RO will review with and make recommendatirms to Company - management for improvements to the in?-astructure, including processes, controls, and monitoring activities. LABORATORY BILLING HOSPITAL LEVEL COMPLIANCE PROCESS REVIEW A. Test of Laboratory Billing Process Controls 1. As part of the Company?s monitoring prom the Company will implement procedures and tools to ensure proper coding and billing oftests by performing the following prpcedmes: a. Apply National Comet Coding (NCCI) edits included in HCFA's Outpatient Code Editor (008) to the Company's Medicare outpatient laboratory billing and test actual claims data for bundling, billing of mutually exclusive codes and comprehensive/component codes simultaneously. b. AdOpt a standard laboratory chargemaster and assess the hospitals? adoption in full of the Company standard. c. Implement edits to prevent duplicate charges on the same claim . d. Analyze frequency o?potential add-on tests, by utilizing benchmarks ?'om non-RCA mm data to compare each hospital?s use ofthe six most common tests that arebilledwith chemistry, organ orblood gas panels to the appropriate industry benchmark for Medime only. Use results to identify hospitals for further review. e. Analyze and institute corrective action plans for signi?cant compliance. issues identi?ed. Assess if Company has taken appropriate steps to ensure over-payments are returned to the payer. 3. Create a compliance risk pro?le for each hospital that summarizes the hospital's: - Accuracy rates of outpatient laboratory billing audits; Use ofthe sixrnost commentests thatarebilled with chemistry, organ or disease, hematology or blood gas panels; Adoption of the standardized laboratory chargemaster; Training and education e?'orts for applicable personnel; Frequency of Billing Compliance Committee meeting; and Appropriate development of action plans; (See AttachmentA for a copy of the Risk Pro?le.) 2. The IRO will: a. Select a 10% random sample of risk pro?les outlined in step m.A.l.g. and compare the information contained in these pro?les to source documents. b. Reperfom the benchmarking process asoutlined in step 111A. l.d; above for a random sample of at least 10% ofthe hospitals. c. Select a random sample of 30 outpatient laboratory overpayments and con?rm that overpayments discovered by the Company were repaid to the appropriate payer. B. Understand and Review the Outpatient Laboratory Billing Compliance Process and Controls 1. Using the results of section the m0 and the Comllany will gain an tmdetstanding of the hospital compliance and control enviromnent and identify the ?higher? risk hospitals for timber process and connol review. The Company will select the higher risk hospitals for detailed process and control testing based on the risk pro?le outlined in section The risk pro?le will consist of a series ofstatlsticalmeasuresaswell aSprocessand controls 100 points. 2. Ataminimum, theIRO below) a minimum of 10%, but no less 20, ofthe Company?s hospitals including at least 2/3 ?higher risk? facilities and randomly selected ?lower a. The hospitals with the lowest combined scores from the risk pro?ling will be considered ?higher risk.? (See attachment A for an ettarnple ofthe risk pro?le). b. The ?lower risk? hospitals will be a random selection of the restraining hospitals not selected in step 3.2a. - c. The number ofhospitals to be tested may vary based on the ?uctuation of the number of hospitals owned by the Company such that approximately the same percentage of facilities are considered ?higher risk? and ?lower risk? each year . 3. The IRO will: a. Read the Cowpany?s Outpatient Laboratory risk pro?le and hospital controls assessment. - b. Compare the information contained in these pro?les for a minimum of 10%, but no less than 20, of the Company's hoSpitals to source documents and recompute each hospital?s overall risk score. c. Compare the Company's identi?cation of the ?higher? risk hospitals to the hospital sample pepulation based on the computed risk score. d. Assess whether the Company's Outpatient Laboratory Risk Pro?le should be amended in light of industry and regulatory changes. 4. For the hospitals selected for detailed review in steps B. 1. and 2. above, the mo will: a. Understand and analyze the hospital?s Outpatimt Laboratory billing processes and controls by interviewing the hospital compliance o?cer, laboratory and billing directors and other key personnel. b. Read documentation at the hospital level that supports the process. c. Document the process and signi?cant controls. d. Compare each hospital?s compliance process with the Company?s Plan and respective policies and procedures and identify variances. e. Understand each hospital?s process for complying with medical necessity requirements speci?c to National Coverage Limitations 6 and/or the Fl?s Local Medical Roview Policies as they pertain to Medicare Outpatientmeme billing and compare to the Company?s Plan. f. Compare the hospital?s use of Outpatient Laboratory billing edits for application ofthe NCCI edits related to Medicare claims to the Company policies and Plan and identify any variances. g. Compare the hospital?s education and training e??orts to the Company?s Plan and verify key participant (Billers and Laboratory Sta?) attendance at relevant training sessions. - 5. Utilizing the Company?s chargemastcr exception reports, the mo will compare each hospital '3 chargemaster to the HCA standard laboratory chargemaster and validate variances for the sample identi?ed in step 2. above. 6. The Company and/or 1R0 will select a random Probe Sample of at least 30 Medicare claims at each selected hospital identi?ed in step Ill. B. 2. above for a Claims Review (including detailed Outpatient Laboratory billing medical necessity review as speci?c in section Ill.B.4.e.). These tests will address key control points that were identi?ed as critical for the sample selected. The procedures that will be performed for this sample are as follows: Compare the test ordered to the test performed Compare the test perfonned to the test billed Compare the test billed to the payment received Review the patient?s medical record (if test performed on a hospital reg?stered outpatient) and determine if the laboratory test(s) wee medially necessary in the diagnosis and treatment of the patient?s illness per National Coverage Limitations and/or the PI's - Based on the results of this testing, the Company and/or IRO will determine whether a Full Sample is required to assess medical neceSsity and billing compliance as follows: a. Ifthe saniple results indicate a gross ?nancial error rate of 5% of thetotal amountreimbmsed forlhoseMedicare claims or less, no?nther testingwill beperformed audit. b. Ifthe initial sample results indicate a gross ?nancial error rate ofrnore than 5% of the total amount reimbursed lin- those Medicare claims, a Claims Review of a Full Sample will be performed. c. For purposes of evaluating the results ofthe samples, an ?overpayment? includes the. following: Atestperformed butwas billed forandresulted in an overpayment to the hospital. - Atcstorpanel oftests determined to lack medical necessity per National Coverage Limitations and/or the and'for which the hospital received payment. An add-ontestspeci?ed intheRisk Pro?lethat was orderedaspan of a chemistry, organ or disease, hematology, or blood gas panel that was determined to be medically unnecessary per HCFA's National Coverage Limitations and/or the ITS and for which the hospital received payment. d. Ifthe Company performs the above testing. the mo will review the testing and conclusions reached by the Company and con?rm that the appropriate follow up steps occur. The IRO will also reperform the' reviews on a random sample of a minimum of 10% ofthe claims reviewed by the Company. IV. REPORTING Upon completion of all testing, the Company will quantify the results and ?ndings will be reported to the 016. The Company?s report will include the following: A. The information required for the Claim Review Report in Appendix A. B. Results of the assessment and testing ofthe Company?s Outpatient Laboratory billing operations (including, but not limited to, the in?mtructure, and weaknesses of the planand process. internal controls, e??eetiveness ofthe overall Outpatient Laboratory Billing compliance prey-am). C. The Company's procedures to correct inaccurate Outpatient laboratory billing and report to the Medicare Medicaid, and other Federal health care programs. D. The steps the Company is takingto bring its Operations into compliance and/or t0'eorrect problems identi?ed by any of the reviews described above. The will read the Company?s results and ?ndings reported to the 016 and issueareportthatenumerates theirproceduresperformed andthe ?ndings foreach procedure. Attachment A l-ch The Heal?lcam Company. LABORATORY RISK PROFILE (C) with 100 points available. (The points available are subject to further :c?ment and negotiations with the 016.) Award up to 4 points semi-annually for accuracy rates for audits performed for the following policies: (8) GOS.LAB 002 Hematology Procedures GOS.LAB.003 Urinalysis Procadra?es GOS.LAB.004 Organ and Disease Panels GOS.LAB.008 Outpatient Specimen Collection (semi-annual accuracy rate a total# audited per policy Wallace minus the total 9 errors lden??ed I lclal of accounts audued per pollcy guidelines) Accuracy rare 95-10036 4 points Accuracy rate 90- 9496 3 points Accuracy rate 7.5- 89% 2 palms Accuracy rate 61- 74% 0 points Accuracy rate 60% or below deduct 2 points Way Audit Perfonnanoo FEB: swan Emcee?mm Woucu? Comm-I Accuracy ?(much Iota-mu Accuracy reviewed reviewed the Hematology Urinalysis Procedures ensues-03 Disease Panels GOSAABJJM Ell! TOTAL SCORE Award up to 3 points per quarter as follows for adoption of Standard Laboratory Chargemaster. based on compliance rate from most current CDM Exception report. Compliance is measured by comparing the facil?y's procedure description. codes and revenue code assignment to the Company standard. (3) 90- 10096 compliance 3 points 80- 8996 compliance 2 points 61- 79% compliance 0 points deduct 2 points 60% or below compliance mm mm 1 . Accuracy Rate (C): Award up to 6 points as follows for accuracy rate for policy 2. GOS.GEN.002. Medicare Medical Necessity. for the quarter being reviewed. The Corporate of?ce will choose the quarter to be reviewed and it will vary from year to year. (quarter accurate] rate total 3 of accounts audited per policy guidelines minus the total errors identi?ed I total 3 of accounts audited per policy guidelines) Accuracy rate 90- 10096 6 points Accuracy rate 75- 8996 3 poiras Accuracy rate 61- 74% 0 points Accuracy rate 60% or below deduct 2 points Action Plane (0): Award 1 point if action plans were developed or were not required accuracy rate 100%). Mm 2 points ifaction plans were required but were not developed. Pellet! Audit Performance Accuracy Action Rate Plan South 1 "m 2 Will error! reviewer! Medicare YIN Medical Necewlty 603631.002 3. Award 2 points iffacility dscloses contents of lab panels on test order forms or other test ordering system and gives physicians the option of ordering each test individually. (Custom pro?les disclosed in accordance with policy 6081.48.00? are considered disclosed.) (C) A 4. Award 2 points personnel review test orders through a manual or automated process prlor to performing mate to ensure the services are medically necessary according to Medicare guidelines Local Medlcal Review Policies (LMRP) and/or National Coverage Limitations (NCL). (C) 5. Award 2 points lilacilily personnel can demonstrate that a process is in place to determine that standing orders are valid. documented, medically necessary and monitored annually for appropriateness. (C) 6. Award 2 points iffacility can demonstrate through a manual or automated process that non?medically necessary services forwhich an ABN ls present are not billed to Medicare as covered services. (C) 7. Award 2 points lfiacility can demonstrate througha manual or automated process that non-medically necessary services for which an ABN is not present are not billed to Medicare or the patient. (C) 8. Award 2 points ifiaciltty can demonstrate through a manual or automated process that services were ordered but not perionned are not billed to Medicare or the patient. (0) - 9. Award 2 points iffacillty can demonstrate through a manual or automated process that services which were not ordered by a physician or other authorized personnel but were performed are not bliled to Medicare. (Medically necessary re?ex testing in accordance with policy GOS.LAB.010 is considered ordered by authorized personnel.) (G) 1mm utoizots Award up to 3 points for each of the following groups that have received initial and/or refresher Laboratory Billing Compliance training within the last 12 months. (C) A) Billing Staff 8) Laboratory Staff 0) Employed physicians who are involved in the ordering. performing. or monitoring of laboratory tests or services or the preparation of Outpatient claims containing laboratory tests or services. Points will be awarded based on the number of trained employees compared to the number on staff in each area: 90- 10096 3 points 80- 89% 2 points 71- 79% 1 point 61- 70% 0 points 60% or below deduct 2 points Award 3 additional points lithe facility can demonstrate that it has provided updated information regarding medical necessity and the ordering of laboratory tasts and services to active staff physicians. (C) 1818 For the quarter in review. compare the volume of each of the following tests. Amylase (82150). iron (83540). Magnesium (83735). Ferritln (82728) and TSl-l (84443). when they are billed with the following Organ and Disease Panels. 80048. 80049. 80053. 80054. tothe total volume of those Organ and Disease Panels. Additionally. compare the volume of Carbon Monoxide (82375) when it is billed with the following Blood Gas Panels. 82803 and 82805. to the total volume at those blood gas panels. These add- on utii'zatlon rates will be compared to an industry benchmark based on the Medicare Standard Analytical File (SAP). exclusive of HOA hospitals. Tests selected for inclusion in the Risk Pro?le may be reviewed and revised annually based on new data. Award 3 points for each test which is at or belowthe current SAF tile industry benchmark. (8) Award 5 points as follows based on the percentage of Billing Compliance Committee meetings held as required by current Company policy duringthe 12-month period being reviewed. Minutes of these meetings must be available. (C) 100% 5 points 90- 997.? 4 points 75- 89% 3 points 50- 7496 1 point 25- 49% 0 points 24% or below deduct 2 points ll. INTRODUCTION . This workplan describes the physician relationships procedures that Healthcare Company (the ?Company") and die Independent Review Organization (?1110?) will tbllow with respect to physician relationships. A public accounting ?rm (the and/or a law ?rm (the ?Legal as appropriate, will perform the role cfthe 1R0 for physician relationships. References to the mo in this document refer to either type of IRO unless speci?cally designated. Ii: PHYSICIAN RELATIONSHIPS CORPORATE COMPLIANCE PROCESS The Legal 1R0 will review all of the Company?s physician relationship policies and con?rm thatthey cover and'seek to ensure compliance with all applicable laws and regulations related to physician relationships, including but not limited to 42 U.S.C. 1320a-7b(b) and 1395mm The Legal IRO will, ?nal time to time, recommend any new policies needed to address changes in the applicable statutes, regulations or case law. PHYSICIAN FACILITY LEVEL COMPLIANCE PROCESS A. UNDERSTAND THE FACILITY PHYSICIAN RELATIONSHIPS PROCESS AND CONTROLS 1. The Coinpany, after consulting with the PA IRO, will select a sample of the greater of 25 facilities or 10% of the ?cilities for a review of its facility level process and controls (the Company will select the randomly except that the Company may choose to selectup to 10 facilities based onthe conclusion thatsuch facilities are at relatively high risk for physician relationship issues - if facilities are chosen based on being high risk the criteria for such seleaion shall be reported to the 016). 2. The Company?s Internal Audit Department (the will obtain an understanding ofthe compliance controls and processes with respect to Physician Relationships (as de?ned below) at the facility by: a) Interviewing facility personnel; Physician Relationships Wo?tplan HCA Comm Agreement 1 b) Reading documentation atthefacility c) Veri?dng the use of various tools. forms and other materials provided to the ?cilitles ?'om Corporate; and d) Documenting the process an! signi?cant control points in the workpapers. 3. Company?s policies andprocedurea TheiADwill identify any control ape orpoints within the processes for the facilities selected that may resplt in non-compliance based onl its documented understanding of the processes and controls at each facility second. 4. The will validate the data contained in the Physician Receivables Database (as de?ned in Section [113.1(3) below) and the property managers? reports (as de?ned in Section mB.l(b) below) by comparing the information on site atthe facility to the information contained in the database and the property managers? reports. 5. The PA IRD will retest and validate the work performed pursuant to Sections 111A and ms. 1(a) ?ll! a random sample of the genie: of 5 ?cilities, or (ii) 10% of the facilities reviewed pursuant to Section mar above. B. REVIEW OF OUTLIER PHYSICIAN CONTRACTS AND The Company will idmtil?y those physician relationships with the greatest risk of non- compliance with applicable law. The Company will do so by identifying and examining relationships that meet the following descriptions: i) loans and other physician accotmts receivable which are past due; ii) leases of buildings where physicians have o?ces (?Medical O?ce Building? or leases); and personal services agreements (cg, - medical directorships and consultancies) and other payments to physicians (collectively, all of the above are referred to as ?Physicim Relationships"). In addition, the 016 may notify the Company that it should examine additional types ofrelationships. To . implement a review of outlier areas, the Company will take the following steps: 1. The Company will identify ?outlier? Physician Relationships for ?nther review as follows: a) Physician Receivables Database?me Cunpany will annually collectdata regarding loans, leases, incomeguatmteerepaymentsand otheracconnts owed by physicians to the Company and maintain this information in a corporate Physician Receivables database Using this database, the Company will identify receivables that meet the following conditions i) over 120 days Physician mm 2 delinquent; and ii) have not been referred to outside counsel for collection within 30 days ofbecoming 120 days delinquent. The database will be ThelADwillsend acopyofthedatabasetotheLegal Department for review and any'nccessary corrective action. b) professional independent third-party managers. The property managers will exceptasnoted: leases, (2) the rent payable under the leases is fair market value (forthepurposes ofthis worirplan. FMV musthe determined without taking into accountthe volume orvalue of any refunds or otherbusiness generated between the parties), (3) all lases would be commercially reasonable even ifno re?nals were made between the parties, and (4) all rental payments are either cmrent or appropriate collection activities are being pursued. The forwarded to the Any MOB leases that are noted as exceptions to the cati?cationswillbe forwardedto?reLegal forreviewand any necessary corrective action. c) Internal Audits-The IAD willperform areview of: facility and regional level personal services ageemaits with physicians (including medical directorship agreements and consultation agreements); and (2) payments to physicians from ?cility. regional, and corporate levels through accounts payable records) using the sample of the Company?s ?tcilities selected in Section above and perform the following steps: i) Identify personal service agreements and/or payments to physicians with the following characteristics: - Payments made to physicians inconsistent with the contract, without a contact, or without documentation of services rendered as required by the contract; - Personal service agreements (considering all agreements and arrangements with the physician ageements) providing for: (1) compmsation of morethan $150 per hour (this amount a?erzom in order to adjust for in?ation) without veri?cation by an independent thirdparty; or(2)providing formorethan40hourspermonthtoa physician withom a veri?cation by an independent third party (unless thenumber ofhours inexoessof?hourspermon?rset forthinthe agreement is required by the applicable statute(s) and/or regulation(s)); Physician Relationships 3 - Multiple medical directorships atthe same facility with the same apparent ?tnction where the physicians are not demonstrated co-directors; - Leases veri?cation by an independent third party; or 0 Physician recruitment arrangements that: (1) do not meet the standards of 42 USS. l395nn and the related regulations; (2) involve the recruitment ofa physician with an activepractiee located within 25 miles ofthe ?cility; (3) involve a total payment/repayment (or forgiveness) period ofmore than 4 y; (4) involve "additional m' di?erentincentives to relocate." (as described in policy on physician recruitment agreements) totaling $25,000 or more; (5) involve recruitment by an ASC or home health agmcy (ratherthan ahospital); areth supported by accrti?eation ?'oma physician. .In addition. a random sample of 20% of all arrangements involving recruitment to join a physician practice under which the facility is making payments shall be identi?ed for fin-the: review. ii) Items noted during the IAD reviews identi?ed in step as potential compliance forreviewandany necessary corrective action. ?Corrective action? as to the ageements listed in this Section [11.3.1 may mean enforcing the terms of the meat agreement, creating a new written amtwhere there was not a current agreement, amending a current written agreemmt. orterminathig an agreement. 2. The Legal Department will review all Physician Relationships referred to it by the IAD as outlined above. The review shall include an examination of all relevant facts, egg the terms ofthe contract, adherencetothose terms. the facility?sneed furthe services described in the contract and those provided, all payments to the physician, the referral patterns ofthc physician, evidmce ofwork actually performed by physician (.93., contemporaneous time records), the FMV of the services provided by the physician, and the commercial reasmablmess of the arrangement. Relevant ?ats in physician recruitment arrangements where the physician joins a group practice - include: (I) the overhead and opaatingexpenses included in the guarantee amount; (2) the marg?nal overhead and operating expmses emaciated with the recruited physician; (3) the ancillary reVenuas (e9, labs, x?rays) associated with the recruited and (4) the ancillary revenues re?ected hr the cala?ation ofthe net collectable revurues. The review-shall include doetnnt review and in-person or telephone interviews with facility personnel where appropriate. .After the review, the Legal Department shall take the following steps: a) Document its ?nding and conclusions for each relationship reviewed; b) Determina whether the relationships require corrective action; Physician Relationships Workplan HCA Cor-pm lntegity Agreement 4 c) Prepare corrective action plans as appropriate; the Vice President, Legal Operations. for review. The IAD will verify that the Legal Departmenthas reviewed all relationships adispositionfonnand correcn?ve action plan where 3. The Log] IRO will reevaluate the appropriates of the conclusions and corrective action plans, if applicable, prepared by the Legal for 10% of the issues identi?ed as outliers. The outliers to be reevaluated shall be randomly selected. The fordeterrnining outliersas set forth in section 31.3.1 to determine if they are appropriately identifying problematic matters. IV. REPORTING Upon completion of all testing of process semis and investigative procedures, the Company will report the following to the 010 in the appropriate Annual Reports (and earlier if so required under the CIA): 1. Physician Relationships which constitute Reputable as determined by either the Company (including the Legal Department and IAD) or the Legal mo. 2. A description of all Physician Relationships for which the Company or the Legal IRO determines corrective action is necessary, and a description of the corrective action plan and its execution. 3. A summary ofthe ?ndings of the Legal Department, IAD, and the 1110(8) resulting horn their reviews (for the reviews of outlier physician contracts and payments described in Section 111.13, the summary shall describe the relevant facts for each such outlier as set forth in Sec?on 1113.2). 4. Material changes in the Company?s physician relationship policies. 5. Material changes in the Company?s physician relationship processes. Physician Relationships Workptan BOA Gar-pom: lategity meat 5 . am mm I. This Workplan'describes the review process that HCA The Healthcare Company (the ?Compan? and the Independent Review Organimtion will follow with respect totestingtheCompany?s Payment billing and coding processes. The 1R0 will gain an tmderstanding ofthe Company?s processes and controls that are designed to prevent and detect billing and coding errors on acute care hospital-based Medicare OPPS claims. The focus ofthe procedures will be on the Company?s acute care hospitals? processes and controls designed to ensure compliance with OPPS billing and coding requirements. II. OPPS CORPORATE COMPLIANCE PROCESS The RC will begin its understanding of the Company's OPPS billing and coding compliance by understanding the Corporate leVei OPPS processes. The focus will be on the Company's controls a??ecting the acute care hospitals. A?er gaining this understanding, the mo and the Company will design agreed upon procedur that will allow the Company and the 016 to evaluatethe e??ectiveness of the Corporate OPPS in?-astruenne. Focusing on the Company?s ini?rastrucnn'e, processes, controls and monitoring systems, the IRO will: A. Understand Acute Care Hospital-Based Medicare OPPS Billing and Coding Processes The IRO will obtain an understanding of the regulatory environment, of key assumptions underlying the acute care hospital-based Medicare OPPS process and how they impact the Company?s compliance ?ak. flhe 1R0 will tmderstand how the Company establishes acute care hospital-based Medicare OPPS billing'and coding procedures. The following interviews/reviews will be performed to understand the education, implementation and monitoring of acute care hospital-based Medicare OPPS: 1. Read organimtional charts and Imderstand OPPS infrastructure. 2. Interview the Corporate Ethics and Compliance Of?cer. VP Govamnental Operations Support (COS), VP Health Information Management Services and other key personnel to understand how acute care hospital-based Medicare . OPPS billing and coding decisions are made. Read policy and procedure manuals, trainingmaterials and other tools and resources. Compare policy and procedure manuals. training materials, tools and resources, identi?r variations and determine variations di?er ?'om acute care hospital- based Medicare OPPS rides, regulations or program memoranda. Understand how the Company monitors acute care hospital-based Medicare OPPS rules,regulations Company's policy and procedure manuals, training materials. tools and resources. Understand the process used to notify acute care hospitals of changes in the Medicare OPPS rules. regulations, new or revised program memoranda and billing and coding requirements. Read training materials developed at the corporate level and mderstand how they are implted atdre acute care hospihl level. identify critical areas not covered by such training. - B. Reyiew Acute Care Hospital-Based Medicare OPPS Controls The 1R0 will understand how the Company ensures that controls are in place to support appropriate acute care hospital-based Medicare OPPS billing and coding. Procedures to gain this understanding include: - 1. Underst the use and role of the Medicare Outpatient Code Editor (OCB), APC Finder and Encoder through discussions with 608 VP, HIMS VP, Director, 608 Monitoring and other key personnel. Understand the process for notifying acute care hospitals of the appropriate APC reimbursed chargemaster driven codes that are included in the acute care hospital?s chargemaster. Read a random sample of training pregams and related materials to assess implementation and consistency with Select a random sample of 10 acute care hospitals ?rm the Corporate compliance training database and test for acute care hospital attendance/participation. Understand the Company?s em to keep abreast ofnew acute care hospital- andchanges and understanth the Company informs its acute carehospitals to conform theirhillingand coding processes and comic to such a diange(s). - 2 6. Determine whether changes in or new acute care hospital Medicare OPPS billing and coding rules and requirements have been incorporated into the appropriate policies, resources and tools. C. Understand Acute Care Hospital-Based Medicare OPPS Billing and Coding Monitoring Function The RC will tmderstandhowthe Company measures, monitors and assesses compliance with acute care hospital-based Medicare OPPS rules and regulations through the following procedures: 1. Interview theCotporateEthics and Compliance O?eer, HIMS VP, GOS VP and other key personnel. 2. Identify the types ofmonitoring plans, tools and reports that are in place to identify. correct and prevent acute care hospital-based Medicare OPPS billing and coding errors. 3. Review a random sample of lo remit: of monitoring activities, including corrective actionpians. hospital?based Medicare billing and coding rules and regulations and identify any non-conformance. 4. Compare plans, tools, and reports to rules, regulations and program memoranda, identify variances and make recommendations for additional tools to facilitate monitoring activities. E. Summarize the Acute Care Hospital-Based Medicare OPPS Billing and Coding Compliance Process The lROwili summarize itSprooedm'esand?ndings ?'omsectionsllAthroughC outlined above to allow the 016 and the Company to evaluate the following: 1. Whether the established acute care hospital-based Medicare OPPS in?asuucttne is success?rlly designed to comply with relevant regulations. 2. Whether the Company's eidsting processes, controls and monitoring address major areas of acute are hospital-based Medicaie OPPS compliance risk. 3. Whether controls may not exist in certain areas to reduce riskto an appropriate level. . 4. The IRO will review with andmake recommendations to Company management for imppvemen? to the in?asu-ucttne, including processes, controls, and monitoring activities. MEDICARE OPPS ACUTE CARE HOSPITAL LEVEL BILLING AND CODING COMPLIANCE PROCESS REVIEW A. Test ofAente Care Hospital-Based Medicare OPPS Billing and Coding Process Controls 1. Fortbepmpose acute care hospital-based Medicare outpatient claim that result in an APC assignmt. 2. As part of the Company?s moniton?ng program, the Company will implement appropriatemocedmes and tools billing of acute care hospital-based Medicare OPPS claims by performingdie following procedtn'es: a. Apply National Correct Coding Initiativo (NCCI) edits and other edits included in the Outpatient Code Editor (OCE), APC Finder and/or Encoder to acute care hospital-based Medicare OPPS claims. b. implement edits to prevent duplicate charges on the same claim. c. Analyze and institute corrective action plans based on identi?ed compliance issues. d. implement appropriate steps to ensue overpayments for APC reimbursed items are returned to Medicare. B. Understand and Review the OPPS Billing and Coding Compliance Process . and Controls 1. The and/or the Company will subject a sample of 10% of the Company?s hospitals for detailed process and control testing. 2. Fortheactne instep i above the Company andlortheIRO will: a. Understandand analyzetheaeutecarehospital sMedicareOPPSbiilmg andcodingproeesses compliance o?cer, HIMS and billing directors and other key Read documentation at the acute care hospital level that supports the process. Observe the use ofvarious tools and materials provided to the acute care hospital from the Corporate O?ce. d. billing and coding education and training requirements. Verify key participant (billets and coders) attendance at relevant training sessions. e. Determine howthe acute carehospital usesthe system editreports to correct claims before they are billed. f. Document the process and signi?cant controls. 3.- The Company and/or IRO will select, for each hospital identi?ed in step 1. above, a random sample of 50 acute care hospital-based Medicare OPPS claims that include at least?one APC reimbursed line item for a detailed claims review. The procedures that will be for this sample are as follows: Compare the APC services ordered to the APC services perfonned Compare the APC services performed to the APC services billed Compare the APC services billed to the APC payment received Validate the accuracy of the diagrasis codes for services Validate the acctn'acy of the codes that result in APC assignmenKs) Validate the accuracy of the units billed that malt in APC assignment(s) Validate the accuracy ofmodi?ers on codes that impactAPC assignment(s) Validate the accuracy of condition codes that are present on the claim that pertain to acute care hospital-based Medicare OPPS Determine whether any modi?ers or condition codes pertaining to acute care hospital-based Medicare OPPS that should be present on the claim are missing . Validate that the appropriate codes and revenue codes hevebeenassigned toapproved 4. For purposes of evaluating the testing results ofthe sample, an ?overpayment? includes the following: - and resulted in an overpaymenttothehospital. servicethatwasperfmedas orderedhutwashilledina manner that resulted in an overpayment to the hospital. . . The Company and/or 1R0 will simunm'ize the results of these reviews. . Based shall createenaction plan that is appropriate to the ?ndings. The hospital shall also repay any APC overpayments to Medicare. 7. Based upon the results of the review, the Company shall develop and - implement, as appropriate, additional resources, training or tools to immove processes and/or correct identi?ed de?cimcies. h. Ifthe Company performs the above testing, the will: a. Read the Company?s docmnenta'tion regarding the review results and determine whether the appropriate reviews as de?ned in step 3. above were performed. b. Repel-form the reviews at 3 of the hospitals reviewed by the Company. c. Review the testing and conclusions reached by the Company and con?rm that the appropriate follow up steps occur. IV. REPORTING Upon completion of all testing, the Company will quantify the results and ?ndings will be reported to the 016. The Company?s report will include the following: A. Information on the results of acute care hospital-based Medicare OPPS claim B. Results ofthe assessment and testing ofthe Company?s acute care hospital- besed Medicare OPPS billing and coding operations (including, but not limited to, the in?astrucnne, and weaknesses ofprocesses and procedures, internal comrols. and e??ectiveness ofthe overall OPPS complianceprogram. C. The Compmy?s procedures to correct'inaccm'ate acute care hospital-based Medicare OPPS billing and coding. D. identi?edbyanyof?rereviews described above. v. ANNUAL REVIEW on THE MEDICARE ores WORKPLAN Because of the recent implementation the Company shall review andlor revise this Workplan annually to incorporate new processes and procedures necessitated by acute care hospital-based Medicare OPPS rules, regulatio or prom memoranda. The Company may also revise this Workplan other than annually ifadditional clari?cations about acute care hospital-based Medicare OPPS that impact the Company?s procedures and processes become known. No revi3ions shall he made to the Workplan without OIG approval. Filing 37681698 E-Filed 02/11/2016 09:30:00 AM Code of Conduct . 1.32545? any. 5 . .Vl' Dear HCA Colleague, We have a comprehensiye. [Ethics and Compliance Program, which is a Vital part ol' the way we conduct ourselves at Because the Program rests on our Missith and Values. it has easily heeonn- incorporated into our daily activities and supports our tradition ot'carint;r for our patients. our communities. and ottr colleagues. We slriye to deliver healthcat?e compassionately anti to act with ahsolute integrity in the way we do our work and tile way we live our lives. This Code of ('ontluet. which reflects our tradition oi'cat'ing?. ['n'oyides guidance to ensure our work is done in an ethical and legal ntanner. It emphasizes the shared values and culture which guide our actions. It also contains resources to help resolve any questions about appropriate conduct in the work place. Please review it thoroughly. Your adherence to its spirit. as well as its specific provisions. is critical to our i'uture. lfyou have questions regarding this Code or any situation which you helieve violates provisimts ol? tltis t?ode. you should immediately consult. your supervisor, another men?thet' ol' management at your i?acility. your liacility lltunan lx'est'ntrees Manager, your Facility Ethics and Compliance t'il?l'tcer, lhe l-lCA [Ethics Line or the Corporate Ethics and Compliance Ol?l'tcer. You have our personal assurance there will he no retriimtion for asking questions or raising concerns about the Code or for reporting possible improper conduct. l\'o Code ol? (.?ontluct can substitute i'or each person?s own internal sense of l?airness. honesty, and it'tteg?rity. lines. in your daily me and work, il'you et'tcounter a situation or are considering; a course of action that does not feel right. please discuss tlte situation with any ol? the resources mentioned ahove. We have a rich heritage. which is re?ected in ottr Mission and Values Statement and in this (Tode ol? Conduct. We are equally committed to .?tssuring our actions consistently rellect our t-vords. [n this spirit. we want this organization to he a community oi?shared values. and we expect all of our colleagues? actions to re?ect the high standards set I'orth in this Code oi? Conduct. We ask you to assist us and all ol?onr colleagues in this organization in supporting the values and principles that are critical to continuing our tradition of caring. Sincerely. Richard M. Bracken Chairman and (?lticl' lixeentiye Ui?l'tcer Mission and Values Statement Purpose of Our Code of Conduct Code of Ethics for Senior Financial Of?cers and the Chief Executive O?icer Leadership Responsibilities Our Fundamental Commitment to Stakeholders Patients Quality of Care and Patient Safety Patient Rights Patient Information Emergency Treatment Physicians Interactions with Physicians Extending Business Courtesies and Tokens of Appreciation to Potential Referral Souices Legal and Regulatory Compliance Accreditation and Surveys Business and Financial Information Accuracy. Retention and Disposal of Documents and Records Coding and Billing for Services Confidential Information Cost Reports Electronic Media and Security Requirements Financial Reporting and Records Intellectual Property Rights and Obligations Workplace Conduct and Employment Practices Conflict oilnterest Controlled Substances Copyrights Diversity and Equal Employment Opportunity Harassment and Workplace Violence Health and Safety Hiring of Former and Current Government and Fiscal Intermedialy/Medicare Administrative Contractor Employees ineligible Persons Insider information and Securities Trading License and Certification Renewals Personal Use of HCA Resources Relationships Among HCA Colleagues Relationships with Subcontractors and Suppliers Research. Investigations. and Clinical Trials Substance Abuse and Mental Acuity Competitive Activities and Marketing Practices Antitrust and Unfair Competition Marketing and Advertising Foreign Corrupt Practices Act Environmental Compliance Business Courtesies General Receiving Business Courtesies Extending Business Courtesies to Non?referral Sources Government Relations and Political Activities The Company?s Ethics and Compliance Program Program Structure Setting Standards Training and Communication Resources for Guidance and Reporting Concerns Personal Obligation to Report Internal Investigations oI'Reports Corrective Action Discipline Measuring Program Effectiveness Mission and Values Statement We recognize and a?irm the unique and intrinsic worth. of each individual. We treat all those we serve with. compassion and kindness. We act with absolute honesty, integrity and fairness in the way we conduct our business and the way we live our lives. We trust our colleagues as valuable members ofoar healthcare team and pledge to treat one another with. loyalty, respect, and dignity. Code of Conduct Purpose of Our Code of Conduct Out Code of Conduct provides guidance to all I-ICA colleagues and assists us in carrying out our daily activities within appropriate ethical and legal standards. These obligations apply to our relatiouships with patients. affiliated physicians. third?party payers. subcontractors, independent contractors. vendors. consultants, and one another. The Code is a critical component of our overall Ethics and Compliance Program. We have developed the Code to ensure we meet our ethical standards and comply with applicable laws and regulations. The Code is intended to be comprehensive and easily understood. In some instances, the Code deals fully with the subject covered. In many cases, however. the subject requires additional guidance for those directly involved with the particular area to have sufficient direction. To provide additioual guidance, we have developed a comprehensive set of compliance policies and procedures which may be accessed on the Ethics and Compliance site of our Intranet, as well as our external web site at Those policies expand upon or supplement many of the principles articulated in this Code of Conduct. The standards set forth in the Code apply to all facilities and employees operating in the United States. The standards are mandatory and must be followed. A separate Code of Conduct has been developed for our facilities outside the United States. Code of Ethics for Senior Financial Officers and the Chief Executive Officer Under the Sarbanes?Oxley Act of 2002 and related Securities and Exchange Commission (SEC) rules, the Company is required to disclose whether it has adopted a written Code of Ethics for its Senior Financial Officers and the Chief Executive Officer Any amendments to. or implicit or explicit waiver of, the Code of Ethics for Senior Financial Of?cers and the CEO must be publicly disclosed as required by SEC rules. "Senior Financial Officers" include, but are not limited to, facility, Division and Group Chief Financial Officers and controllers, and Corporate officers with ?nancial accounting and reporting responsibilities. including the Executive Vice President and Chief Financial Officer. The Code must be reasonably designed to deter wrongdoing and to promote: honest and ethical conduct, including the ethical handling of actual or apparent conflicts of interest between personal and professional relationships; full. fair, accurate, timely and understandable SEC filings and submissions and other public communications by the Company; compliance with applicable governmental laws, rules and regulations; prompt internal reporting of violations of the Code; and accountability for adherence to the Code. The CEO and all Senior Financial Officers are bound by all provisions of this Code of Conduct and particularly those provisions relating to ethical conduct, con?icts of interest. compliance with law. and internal reporting ofviolations ofthe Code. The CEO and all Senior Financial Of?cers also have responsibility for full. fair, accurate, timely and understandable disclosure in the periodic reports and submissions filed by the Company with the SEC as well as in other public communications made by the Company (?Public Communications"). Accordingly, it is the responsibility ofthe CEO and each Senior Financial Officer to bring to the attention of the internal working group responsible for the review of the Company's periodic SEC reports (?Disclosure Committee") any information of which he or she may become aware that materially affects the disclosures made by the Company in its 5 Public Communications. The CEO and each Senior Financial Officer also shall bring to the attention of the Disclosure Committee any information he or she may have concerning significant deficiencies in the design or operation of internal controls which could adversely affect the company's ability to record, process, sun'nnarize and report financial data; or any fraud, whether or not material, that involves management or other employees who have a significant role in the Company?s financial reporting, disclosures or internal controls. The Corporate Ethics and Compliance Steering Committee shall determine appropriate actions to be taken in the event of violations of the Code by the CEO and the Company's Senior Financial Officers. Such actions shall be reasonably designed to deter wrongdoing and to promote accountability for adherence to the Code. In determining what action is appropriate in a particular case, the Corporate Ethics and Compliance Steering Committee shall take into account all relevant information, including the nature and severity ofthe violation, whether the violation was a single occurrence or repeated occurrences. whether the violation appears to have been intentional or inadvertent, whether the individual in question hatl been advised prior to the violation as to the proper course of action and whether or not the individual in question had committed other violations in the past. The Corporate Ethics and Compliance Steering Committee must report periodically any actions taken pursuant to this paragraph to the Audit and Compliance Committee of the Board of Directors. Any waiver of or amendments to the Code of Ethics for Senior Fine-incial Officers and the CEO must be approved by the Audit and Compliance Committee of the Board of Directors. Code of Conduct Leadership Responsibilities While all l-lCA colleagues are obligated to follow our Code. we expect our leaders to set the example, to be lit every respect a model. We expect cveryt'ittc itt the organimtion with supetvisorv t'est'tonsihility to cxr-rcise that responsibility in a manner that is kind. sensitive. thoughtful, and respectful. We expect fEltfl't supervisor to create an environment where all team members are encouraged to raise concerns and pmpose ideas. We also expect that they will ensure tltose on their teatn have suf?cient information to comply with laws, regulations. and policies, as well as the resources to resolve ethical dilemmas. they must help to create a culture within which promotes the highest standards of ethics attd compliance. This culture must encourage everyone it] the organization to share concerns when they arise. We must never sacrifice ethical and compliant behavior in the pursuit of business Specific guidance for leaders throughout the organization t'egtt-trding their responsibilities under our lithics and Compliance Program is included in a supplet?ttent for leaders to this Code. Leaders at all levels of the organization should use that guidance to most effectiver incorporate ethics anti compliance into all aspects of our organization. In addition. all leaders should be that supports and utilizes various training mechanisms to ensure that our supervisors have excellent managerial skills. These training tools are coordinated b_v the Corporate Human Resources ?l'hc foundational principles in such tools re?ect the hasic concepts of our Ethics and Compliance Program. The titltics and Compliance Program, together with our leadership training; efforts, encourages what we refer to as "principled leadership." Such leadership assumes that those in ottr organization will lead by will confront problems directly attd candidly. will be inclusive in making decisions as to who should participate the process. will try to give the maximum responsibility to those who work with them. and will emphasize effective team-intildintt. In addition to these fundamental appt'oacl'tes to principled leadership, we expect those in our organization to understand and care about their colleagues at work. Though is a large organization. its work is accomplished each day. for the most part. itt small team settings. This encourages all leaders to try to ensure that the talents of each member of the organization are utilized to the maximum extent possible and that we give careful attention to the professirntal development ofall of those withitt Our Fundamental Commitment to Stakeholders?i We affirm the following commitments to HCA stakeholders: To our patients: We are committed to providing quality To our joint venture partners: We are committed to care that is sensitive, compassionate, fully performing our responsibilities to manage our delivered. and cost?effective. jointly owned facilities in a manner that re?ects the mission and values of each of our organizations. To our HCA colleagues: We are committed to a work setting which treats all Colleagues with fairness, dignity, T0 the communities We serve: We are committed to and respect. and affords them an Opportunity grow, understanding the particular needs of the communities to develop professionally. ant! to work in a team ?we and PrOVlding these communities quality! in which a? idcas are considered. cost?effective healthcarc. We realize as an organization that we have a responsibility to help those in need. We proudly support charitable contributions and events in the communities we serve in an effort to promote good will and timber good causes. To our a?iliated physicians: We are committed to providing a work environment which has excellent facilities, modern equipment, and outstanding professional support. . I To our suppliers: We are committed to lair competition among prospective suppliers and the sense of responsibility required of a good customer. We encourage our suppliers to adopt their own set of comparable ethical principles. To our third-party payers: We are committed to dealing with our third-party payers in a way that demonstrates our commitment to contractual obligations and re?ects our shared concern for quality healthcare and bringing ef?ciency and cost effectiveness to healthcare. We encourage our private third-party payers to adopt their own set of comparable ethical principles to explicitly recognize their obligations to patients as well as the To our volunteers: The concept of voluntary assistance to the needs of patients and their families is an integral part of the fabric of healthcare. We are committed to ensuring that our volunteers feel a sense Head for fairness in dealing With llm?dders- ol' meaningfulness from their volunteer work and receive recognition for their volunteer efforts. To our regulators: We are committed to an environment in which compliance with rules, regulations, and sound To our shareholders; we are committed to the highest business practices is woven into the corporate culture. standards of professional management, which we are We accept the responsibility to aggressively self-govern certain can create unique ef?ciencies and innovative and monitor adherence to the requirements of law and healtheare approaches and thus ensure favorable returns to our Code of Conduct. on our shareholders? investments over the long term. ?The term refers In those trot: is of tn an inulnulinn sec}. Wall :is having l. . Code of Conduct Patients Quality of Care and Patient Safety Our mission is to provide high quality. cost?effective healtl'icare to all of our patients. To that end, we. are committed to the delivery of sale. cl'l'ct'livc. cl?licient, compassionate and satisfying patient care. We treat all patients with warmth. respect, and dignity and provide care that is both necessary and appropriate. HCA has a comprehensive program to promote the quality objectives oi" the organization. In promotingr a high quality of care, I-ICA Facilities are focused on the attentiveness and dedication of service to patients; the utilization of evolving technology to ensure quality and patient safety and to create an overall culture that makes patient safety paramount; a comprehensive and effective approach to handling the issues of credentialing and privileging ol? tnctiiliers oi' the medical stall: and the creation of eiTective peer review mechanisms within the medical stat i. As a general principle, Ilt'r?x aspires to a standard ot?exccilence for all caregivers within its facilities, including the entire facility team. which is committed to the delivery of safe, ci?i?ective, et?ticient. compassionate and satisfying care and services. There are increasingly numerous measures that relate in some way to the quality of patient care. These include, for example, the Conditions ol' of the Centers for Medi "are and Medicaid Services the standards and surveys of The .loint ("ommissiotL the consensus measures of the National Quality Forum, and the principles of the Leapfrog Group for Patient Safety. HCA is attentive to all ot'tltese standards and seeks to establish systems that re?ect the best practices required or implied by these various standard-setting efforts. This commitment to quality ol? care and patient safety is an obligation oi?every HCA colleague. HCA Accordingly. it is a principle of being pan of HCA that each person dedicates himself or herself to achieving the goals described here. In addition, in any where an HCA colleague has a question about whether the quality or patient safety commitments set I?onh herein are being fully met. that individual is obligated to raise this concern through appropriate channels until it is satisfactorin addressed and resolved. Such channels include those established at the facility, and il? necessary. beyond the l?acility, including the HCA lithics Line. In addition to the facility and HCA channels. HCA colleagues are provided resources anti guidance as to how to solicit intervention or review by external quality partners including The .loint Commission. state survey agencies or state quality improvement organizations. Code of Conduct Patient Rights We make no distinction in the avaiiahility of services: the admission. transfer or discharge of patients: or in the care we provide hased on age. gender. disability. race. color, religion. or national origin. We recognize anti respect the diverse backgrounds and cultures of our patients anti make every effort to equip our caregivers with the knowledge anti resources to respect each patient's cultural heritage and needs. We are mindful that the populations in those communities t'c serve are becoming even more diverse. r-?tccordingly. we are structuring more formal programs to ensure that HCA colleagues a re equipped to meet these articulated commitments for multi-cultural competency in patient care. The hospital respects the patients right to anti need for effective communication. Each patient is provided with a written slatemcnt of patient rights anti :1 notice of privacy practices. These statements include the rights ofa patient to make decisions regarding medical care. the right to refuse or accept treatment, the right to informed decision? making, and a patient's rights related to his or her health information n'taintained hy the facility. Such statements Conform to all applicable state and Federal laws. including but not limited to the Health lnsurattce Portabilin and .=\ccountahility Act of 1996 (hereinafter referred to as We seek to involve patients in all aspects of their care. including giving consent for treatment and making healthcare decisions. which may include managing pain effectively, foregoing or withdrat-ving treatment. and, as appropriate, cat": at the end of life. The hospital addresses the wishes of the patient relating to end of life decisions. As applicable. each patient or patient representative is provided with a clear explanation of care including. but not limited to. diagnosis, treatment plan. right to refuse or accept care. care decision dilemmas. advance directive options. estimates of treatment costs. organ donation and procurement, and an explanation of the risks. benefits. and alternatives associated Willi available treatment options. Patients have the right to request transfers to other facilities. In such cases. the patient is given an explanation of the bene?ts, risks. and alternatives of the transfer. Patients are provided information regarding their right to make advance directives regarding treatment decisions. financial considerations and the designation ofsurrogate healthcare decision-makers. Patient advance directives or resuscitative measures are honored within the limits of the law and ottr organization?s mission. [)hiinSt?tpliy, values, and cap:-1hilities. in the promotion and protection of each patients rights. each patient and his or her representatives are accorded appropriate con?dentiality, privacy, security. advocacy and protective services. opportunity for resolution of complaints. and pastoral care or Spiritual care. Patients have the right to an environment that preserves dignity and contributes to positive self?image. Patients are treated in a manner that preserves their dignity. autonomy. self-esteem. civil rights. and involvement in their own care. HCA facilities maintain processes to support patient rights in a collaborative manner which involves the facility leaders and others. These structures are based on policies and procedures. which make up the framework addressing both patient care and organizational ethics issues. 'l'hese structures include informing each patient or. when appropriate. the patient?s representative of the patient's rights in advance of furnishing or discontinuing care. Patients receive information about the personls] reSponsihle for their care, treatment and services. Patients and. when apprt?ipriale. their families are informed ahout the Code of Conduct outcomes of care, treatment and services tltat have been provided. including unanticipated outcomes. Patients are also involved as clinically in resolving dilemmas about care decisions. Facilities maintain processes for prompt resolution of patient grievances which include informing patients of whom to contact regarding grievances and informing patients regarding the grievance resolution. The hospital addresses tlte resolution of complaints from patients and their families. Patients have the right to refuse care, treatment, and services in accordance with the law and regulations. HCA facilities maintain an ongoing, proactive patient safety effort for the identification of risk to patient safety and the prevention, reporting and reduction of l'tealthcare errors. HCA colleagues receive training about patient rights in order to clearly understand their role in supporting tltem. We strive to provide health ?ation. health promotion, and illness?prevention programs as part of our efforts to improve the quality of life of our patients and our communities. Patient Information We collect information about the patient's medical condition, history, medication, and family illnesses in order to provide quality care. We realize the sensitive nature of this information and are committed to maintaining its con?dentiality. Consistent with l-llPAA. we do not use, disclose or discuss patient~specitic inforntatitm, including patient financial information, with others unless it is necessary to serve the patient or required by law. HCA colleagues must never use or disclose confidential information that violates the privacy rights of our HCA patients. In accordance with our privacy and security policies and procedures. which re?ect l-llPAA requirements, no 1-1th colleague, af?liated physician, or other healthcare partner has a right to arty patient information other than that necessary to perform his or her job. Suhject only to emergency exceptions, patients can expect their privacy will he protected and patient? spccitic information will he released only to persons authorized by law or by the patient's written authorizatitm. Emergency Treatment We follow the Emergency Medical Treatment and Active Labor Act: irt providing an emergency medical screening examination and necessary stt-ihilization to all patients. regardless of ability to pay. Provided we ltave the capacity anti capability, anyone with an emergency medical cornlition is treated. in art emergency situation or if the patient is in labor, we will ttot delay the medical screening antl necessary stabilizing tr 'atment in order to seek financial and demographic information. We do not admit, discharge, or transfer patients with emergency medical conditions simply based on their ability or inability to pay or any other discriminatory factor. Patients with emergency medical conditions are only transferred to another facility at the patients request or if the patient?s ntcdieal needs cannot be met at the HCA facility we do not have the capacity or capability} and appropriate care is knowingly availabl at another facility. Patients are only transferred in strict compliance with state and Federal regulatory and statutory requirements. Code 0] Conduc! . ?1 'v 4 I Code of Conduct Physicians llealth care facilities like those owned and operated by HCA a collaboration those who are part of HCA and those who have been credentialed and privileged to practice in facilities. As in any collaboration. each party has important roles and responsibilities. HCA is committed to providing a work environment for physicians and other privileged practitioners who practice in our facilities that is excellent in all respects. We know that historically members of our medical staffs have interacted with those who work in our hospitals in a respectful and supportive way. We appreciate this and know that we can expect it to continue. We encourage members of our Medical Staffs to be familiar with this Code of Conduct. There are many portions of this ode of Conduct that pertain to ethical or legal obligations of physicians in hospitals. and this document is liker to be a helpful summary of those obligations for our medical staff members. Interactions with Physicians Federal and state laws and regulations govern the relationship between hospitals and physicians who may refer patients to the facilities. The applicable Federal laws include the Anti?Kickback Law and the Stark Law. It is important that those ct'illeagues who interact with physicians. particularly regarding making; payments to physicians for services rendered. providing space or services to physicians. recruiting physicians to the community, and arranging for physicians to serve in leadership positions in facilities. are aware of the requirements ofthe laws, regulations, and policies that address relationships between facilities and physicians. If relationships with physicians are properly Structured. but not diligently :ulministered. failure to HCA administer the arrangements as agreed may result in violations of the law. Any arrangement with a pl'tysicitm must be structured to ensure compliance with legal rerpriremeuts, our policies and procedures. and with any operational guidance that has been issued. Most arrangements must be in writing and approved by the Legal Failure to meet all requirements of these laws and regulations can result in serious consequences fora facility. 12 Keeping in mind that it is essential to be familiar with the laws, regulations, and policies that govern our interactions with physicians, two overarching principles govern our interactions with physicians: We do not pay for referrals. We. accept patient referrals and admissions based solely on the patient?s medical needs and our ability "to render the needed services. We do not pay or offer to pay anyone colleagues. physicians, or other persons or entities for referral of patients. We do not accept payments for referrals we maize. No HCA colleague or any other person acting on behalf of the organization is permitted to solicit 0r receive anything of value, directly 0r indirectly, in exchange for the referral of patients. Similarly, when making patient referrals to another healthcare provider, we do not take into account the volume or value of referrals that the provider has made (or may make) to us. Extending Business Courtesies and Tokens of Appreciation to Potential Referral Sources Any entertainment, gift or token of appreciation involving physicians or other persons who are in a position to refer patients to our healthcare facilities must be undertaken in accordance with corporate policies, which have been developed consistent with Federal laws, regulations, and rules regarding these practices. l-lCA colleagues must consult Company policies prior to extending any business courtesy or token of appreciation to a potential referral source. Legal and Regulatory Compliance provides varied healthcare services in many states. These services are provided pursuant. to appropriate Federal, state. and local laws and regulations. and the conditions of participation for Federal healthcare programs. Such laws, regulations, and conditions of participation may include, but are not limited to, subjects such as certificates of need, licenses, permits, accreditation, access to treatment, consent to treatment, medical record-keeping, access to medical records and confidentiality, patients? rights, clinical research, end? of?life care decision?mailing, medical staff membership and clinical privileges, corporate practice of medicine restrictions. and Medicare and Medicaid program requirements. The organization is subject to numerous other laws in addition to these healthcare laws, regulations, and the conditions of participation. We have developed policies and procedures to address many legal, accreditation, certification and regulatory requirements. However, it is impractical to develop policies and procedures that encompass the full body of applicable law, standards, conditions and regulation. Obviously, those laws, standards, conditions and regulations not covered in organization policies and procedures must be followed. There is a range of expertise within the organization. including operations Counsel and numerous functional experts (to, Responsible Executives]. who should be consulted for advice concerning human resources, legal, regulatory, standards and the conditions of participation requirements. Anyone aware of violations or suspected violations of laws, regulations, standards and the conditions of participation, or Company policies and procedures must report them immediately to a supervisor or member of management, the Facility Human Resources Manager, the Facility Ethics and Compliance Officer (ECO), the Division ECO, the Ethics Line, or the Corporate Ethics and Compliance Officer. 13 Code of Conduct Accreditation and Surveys In preparation for, during anti after surveys. HCA colleagues must deal with all accrediting and external agency survey bodies in a direct, open and honest manner. No action shottld ever be taken in relationships with accrediting; or external agency survey bodies that would mislead the accrediting or external agency survey teams, either directly or indirectly. The scope of matters related to accreditation or external agency survey mg is extremely significant and broader than the scope of this Code of Conduct. The purpose of our Code of Conduct is to provide general guidance on subjects of wide interest within the organization. Accrediting bodies and external agency survey entities may address issues of both wide and somewhat more focused interest. i I I From time?to?time. government agencies and other entities conduct surveys in our facilities. We reSpond with openness anti accurate informatirnt. In preparation for or during a stnvey or inspection. HCA colleagues must never conceal, destroy. or alter any documents; lie; or make misleading statements to the agency representative. Colleagues also must never attempt to cause another colleague to fail to provide accurate information or obstruct. mislead, or delay the communication of information or records relating to a possible violation of law. HCA Business and Financial Information Accuracy, Retention, and Disposal of Documents and Records liach HCA colleague is responsible for the integrity and accuracy of our t'irganization's documents and records. not only to comply with regulatory and legal requirements but also to ensure records are available to support ottr business practices and actions. No one may alter or falsify inl?orn?iation on any record or document. Records must never be destroyed in an effort: to deny governmental authorities that which may he relevant to a government investigation. Medical and business documents anti records are retained in accordance with the law and our record retention policy. which includes comprehensive retention schedules. Medical and business documents include paper documents such as letters and memos. computer~ based information such as e?mail or computer files on disk or tape, and any other medium that contains information about the organizatit'm or its business activities. It is important to retain and destroy records only according to our policy. l-lCA colleagues tnust not tamper with records. No one may remove or destroy records prior to the speci?ed date without ?rst obtaining permission as outlined in the Company records management policy. Finally. under no circumstances may no IICA colleague use patient. colleague or any other individual?s or entity's information to persrmally bent-lit lc.g., perpetrate identity theft). Coding and Billing for Services We have implemented policies. procedures and systems to facilitate accurate billing to government payers. commercial insurance payers. and patients. These policies. l4 Code of Conduct procedures, and systems conform to pertinent Federal and state laws anti regulations. We prohibit any coll=ague or agent from knowingly presenting or causing to be presented claims for payment or approval which are false, fictitious. or fraudulent. in support of accurate billing, medical records must provide reliable doctm?rentatio.n of the services we render. It is important that all individuals who contribute to medical records provide accurate information and do not destroy any information considered part of the official medical record. Accurate and timely documentation also depends on the diligenc= and attention of physicians who treat patients in our facilities. We expect those physicians to provide us with complete and accurate information in a timely manner. Arty subcontractors engaged to perform billing or coding services are expected to have the necessary skills, quality control processes. systems, and appropriate procedures to ensure all billings for govern ment and commercial insurance programs are accurate and complete. HCA expects such entities to have their own ethics and compliance programs and code of conduct. In addition, third-party billing entities, contractors, anti preferred vendors under contract consideration must be approved consistent with the corporate policy on this subject. For technical coding questions in a hospital or ambulatory surgery center contact the 3M Coding Helpline at lior billing and other coding questions in a hospital. freestanding imaging/radiation oncology center. or physician's practice, contact the Regs Helpline by e?mail at Regs l-lelpiine. Con?dential Information The term ?confidential information" refers to proprietary information about our tnganizrrtirrn's strategies and operations as well as patient inlornratitm and third party information. improper use or disclosure of confidential information could violate legal and ethical obligations. HCA colleagues may use confidential information only to perform theirjob responsibilities and shall not share such information with others unless the individuals and/or entities have a legitimate need to know the information in order to perform their specific job duties or carry out a contractual business relationship, provided disclosure is not prohibited by law or regulation. Confidential information, also referred to as "sensitive informatimr," covers virtually anything related to operations that is not publicly known, such as personnel data maintained by the organization: patient lists and 15 Code of Conduct clinical information, including individually identi?able patient information; patient ?nancial information. including credit card data and social security numbers: passwords: pricing and cost data; information pertaining to acquisitions. af?liations anti mergers: financial data; details regarding federal, state. and local tax examinations of the organization or its joint venture partners; proprietary information from a research sponsor or the data generated from the research; strategic plans; marketing strategies and techniques; supplier and subcontractor information; and proprietary computer software. In order to maintain the confidentiality and integrity of patient and con?dential information. colleagues must protect at. . such information in accordance with information security policies and standards when it is e?rnailed outside the. Company or otherwise sent through the Internet: stored on portable devices such as laptops and portable digital assistants (i?DAsl; or transferred to removable media such as CD or USB drive. these policies anti standards require, among other things, that the individual and/or entity be validated and the information be Use of due care and due diligence is required to maintain the con?dentiality, availability and integrin of infortm-ition assets the Company owns or of which it is the custodian. Because so much of our clinical and business information is generated and contained within 16 Code of Conduct our computer systems, it is essential that each HCA colleague protect our computer systems and the information contained in them by not sharing passwords and by reviewing and adhering to our information security policies and standards. Any HCA colleague who knows or suspects con?dential information to have heerr compromised must report the potential security breach to the Facility ECO, Facility Privacy Uflicer or Facility Information Security Official (F180). If an individual's employment or contractual relationship with HCA ends for any reason, the individual is still bound to maintain the con?dentiality of information viewed, received or used during the employment or contractual business relationship with HCA- This provision does not restrict the right of a colleague to disclose, if he or she wishes, information about his or her own compensation, bene?ts, or terms and conditions of employment. Copies of con?dential information in an employee?s or contract'Or's possession shall be left with HCA at the end of the employment or contractual relationship. Cost Reports We are required by Federal and state laws and regulations to submit certain reports ofour operating costs anti statistics. We comply witl'r Federal and state iaws, regulations. and guidelines relating to all cost reports. These laws, regulations, and guidelines define what costs are allowable and outline the appropriate methodologies to claim reimbursement for the cost of services provided to program beneficiaries. Several HCA policies address cost report compliance anti articulate our commitment to: maintain and distribute a Reimbursement Manual to Reimbursement Department: personnel that includes corporate and departmental policies and procedures; provide effective and timely education and training programs for Reimbursement Department personnel regarding Federal and state laws, regulations and guidelines. and corporate policies; maintain a standardized workpaper package to provide consistency in the preparation, organization, presentation, anti review of cost reports; apply a uniform cost report review process; identify and exclude non?allowable costs; adhere to documentation standards; and use transmittal letters to report protested items and make other appropriate disclosures. Also, we submit our cost report process to internal audits anti maintain a peer review process. All issues related to the preparation, submission and settlement of cost reports must be performed by or coordinated with our Reimbursement Department. Electronic Media and Security Requirements All communications systems, inciuding but not limited to computers, electronic mail, Intranet, Internet access. telephones, and voice mail, are the property of the organization and are to be used primarily for business purposes in accordance with eiectronic communications policies and standards. Limited reasonable personal use of communications systems is permitted; however, users should assume these communications are not private. Users of computer and telephonic systems should presume no expectation of privacy in anything they create, store, send, or receive on the computer and telephonic systems, and the Company reserves the right to monitor and/0r access communications usage and content consistent with Company policies and procedures. Code of Conduct Colleagues may not use internal communication channels or access to the lnternet at work to view, post. store. transmit. or distribute any threatening materials; knowingly. recklessly, or maliciously lalse materials; obscene materials; or anything constitutingr or encouraging a criminal ol't'ense. giving rise to civil liability, or otherwise violating any laws. Also. these channels of communication may not be used to send chain letters, personal broadcast messages, or copyrighted documents that are not authorized [or reproduction. Colleagues who abuse our communications systems or use them excessively Ibr aim?business putposes may lose these privileges and be subject to disciplinary action. Colleagues shall comply with llCA's it'll'ortnation security policies and standards governing the use of. information systems. Only assigned user IDs and "SecttrelD" cards sllall he used. Individuals may only use of?cially assigned User le and passwords and are not permitted to share or disclose any passwr?rrd that is used to access llt.?r\ systems or information. Portable devices and removable media. such as laptop computers, USB drives, (Us and external hard drives, must be physically secured at all times. Colleagues shall never use tools or techniques to break or exploit llt?A information security measures or those used by other companies or individuals. Financial Reporting and Records We have established and maintain a high standard oi accuracy anti in maintaining. and reporting Financial inl?ormation. This information serves as a basis for managing ottr business and is important in meeting our obligations to patients. colleagues. shareholders. suppliers. and others. it is also necessary for compliance with tax and linancial reporting requirements. All financial information must reflect actual transactions and conform to generally?accepted accounting [:irinciples. All Funds or assets must be properly recorded in the hooks and records of the (?ornpz-my. l-lCA nurintains a system of internal controls to provide reasonable assurances that all trz-tnsaclions are executed in accordance with management?s authorization and are recorded in a proper manner so as to maintain accountability ol' the organization's assets. We diligently seek to comply with all applicable auditing. accounting and ?nancial disclosure laws, including but not limited to the Securities Exchange Act. oi? 1934 and the Actt of 2002. Senior financial ol?licers t'ect.'ive training and guidance regarding l8 Code of Conduct auditing. accounting and financial disclosure relevant to theirjob responsibilities. They are also provided the Opportunity to discuss issues of concern with the Board of Directors' Audit and Compliance Committee. Anyone havinpr concerns regarding questionable accounting or auditing matters should report such matters to the Board of Directors? Audit and Compliance Committee by calling the Ethics Line Intellectual Pmperty Rights and Obligations Any work of authorship. invention, or other creation ("Development") created by a colleague during the scope ol? the colleague's employment with HCA shall be considered the property of l-iCA. including any patent. trademark, copyright. trade secret or other intellectual property right in the Development. Whether something is developed during tlte scope of a colleague's employment depends on a number of factors. including: the nature ol?rhe colleague's work. whether the Development is related to business, whether the colleague was directed to produce the Development as part of the colleague's work. whether the colleague utilized llCA intellectual property or resources at least in part to make the Development, and whether the colleague created the Developr'nent while being paid by HCA. ll" any Development created is copyrightable or patentable, then it will be considered a ?Work for Hire" under the United States Copyright Act, with HCA being considered to be the author and owner ofsuch work. When creating Developments for HQA, colleagues shall respect the intellectual property rights of others. Any works 0r inventions created by colleagues prior to employment by HCA shall be disclosed to rrpon commencement of employment. and management and Legal Department approval shall be obtaintd prior to any use of these works or inventions in a Development for HCA. By signing the acknowledgment card at the end of this Code oi" Conduct. a colleague speci?cally agrees to be bound by these provisions of the Code of Conduct. As such. the acknowledgment card serves as an assignment by the named colleague to HCA ot?all right, title, and interest in all Developments created by the colleague within the scope of his or her employment. as well as an appointment of the Secretary for as the colleague's attorney-in?fact to execute documents on his or her lrelrall' for the foregoing purposes. Colleagues shall assist MFA in obtaining and enforcing intellectual property rights in their Developments, while employed by and after termination of employment. 19 Workplace Conduct and Employment ?aetices Con?ict of Interest A conflict of interest may occur it an l-lCA colleague?s outside activities. personal ?nancial interests, or other personal interests influence or appear to in?uence his or her ability to make objective decisions in the course 01' the colleague's job responsibilities. A con?ict of interest. may also exist it" the demands of any outside activities hinder or distract a colleague from the performance of his or herjob or cause the individual to use HCA resources for other than HCA purposes. HCA colleagues are obligated to ensure they remain tree of conflicts of interest in the [)ei'fOI'irrance of their responsibilities at HCA. lfcolleagues have any question about whether an outside activity or personal interest might constitute a conflict of interest. they must obtain the written approval of' their supervisor and ECO before pursuing the activity or obtaining or retaining the interest. Clinical decisions will be made without regard to compensation or ?nancial risk to l-lCA leaders, manager?s, clinical stal'l', or licensed, independent practitioners. No waiver of this conflict of interest provision irray be granted to an Executive Officer an of?cer subject to Section to of the Securities Exchange Act ol' 1934} unless approved in advance by the Audit and Compliance Committee of the Board oi" Directors. Controlled Substances Some of our colleagues routinely have access to prescription drugs, controlled substances. and other medical supplies. Many of these substances are governed and monitored by specific regulatory organizations and must be administered by physician order only. Prescription and controlled medications and supplies ntust be handled properly and only by authorized individuals to minimize risks to us and to patients. ll? one becomes aware of inadequate security of drugs or controlled substances or the diversion of drugs from the organization, the incident must be reported immediately. Copyrights l~lCA colleagues may only copy and/or use copyrighted materials pursuant to the organization?s policy on such matters. Diversity and Equal Employment Opportunity l-lCA activer promotes diversity in its workforce at all levels of the organization. We are committed to providint,r an inclusive work environment where everyone is treated with fairness, dignity, anti respect. We will make ourselves accountable to one another for the manner in which we treat one another and for the manner in which people around us are treated. We are committed to recruit and retain a diverse staff reflective of the patients and cornmunities we serve. We regard laws, regulations and policies relating,r to diversity as a tninirntn'n standard. We strive to create and rriaintain a setting in which we celebrate cultural and other differences and consider them of the organization. HCA is an equal opportunity workforce and no one shall discriminate against any individual with regard to race, color, religion, sex, national origin, age, disability, sexual orientation, or veteran status with respect to any offer, or term or condition, of employment. We make reasonable accommodations to the known physical and mental limitations of quali?ed individuals with disabilities. 21 .7.-, -51. - Harassment and Workplace Violence Each IICA colleague has the right to work in an environment free of harassment and disruptive behavior. We do not tolerate harassment by anyone based on the diverse characteristics or cultural backgrounds of those who work with us. Degrading or humiliating jokes, slurs, intimidation. or other harassing conduct is not acceptable in our workplace. Sexual harassment is prohibited. This prohibition includes unwelcome sexual advances or requests for sexual favors in conjunction with employment decisions. Moreover, verbal or physical conduct of a sexual nature that interferes with an individual's work performance or creates an intimidating, hostile, or offensive work environment has no place at HCA. Harassment also includes incidents of workplace violence. Workplace violence includes robbery and other commercial crimes, stalking, violence directed at the employer, terrorism, and hate crimes committed by current or former colleagues. Colleagues who observe or experience any form of harassment or violence should report the incident to their supervisor, the Human Resources Department, a member of management, the Facility ECO. or the Ethics line. Health and Safety All HCA facilities comply with all government regulations and rules, llCA policies, and required facility practices that promote the protection of workplace health and safety. Our policies have been developed to protect our colleagues frorn potential workplace hazards. Colleagues must become familiar with and understand how these policies apply to their specific job responsibilities and seek advice from their supervisor or the Safety Officer whenever the have a question or concern. It is important that each colleague immediater advise his or her supervisor or the Safety Officer of any serious workplace injury or any situation presenting a danger of injury so timely corrective action may be taken to resolve the issue. Hiring of Former and Current Government and Fiscal Intermediary/Medicare Administrative Contractor Employees The recruitment and employment of former or current U.S. government employees may be impacted by regulations concerning conflicts of interest. Hiring employees directly from a fiscal intermediary or Medicare Administrative Contractor requires certain regulz-uory notifications. Colleagues should consult with the Corporate llumarr Resources Department or the Legal Department regarding sUCh recruitment and hiring. Ineligible Persons We do not contract with. employ, or bill for services rendered by an individual or entity that is excluded or ineligible to participate in Federal healthcare programs; suspended or rleharred from Federal government contracts anti has not been reinstated in a Federal healthcarc progran't after a period of 22 Code ofLi?iziidiict' - exclusion. suspension. deliaimcnt. or ineligibility. We routiner search the ot?llcalth and Human Services' Uliice ol' inspector {iencral and General Sen-ices Admittistration's lists ol' such excluded and ineligible persons. A number ol' Company policies address the procedures l'or timely and thorough review at such lists and appropriate enforcement actions. Colleagues. vendors. and privileged practitioners at one or more llCA facilities are required to report to us it they become excluded. deharretl, or ineligible to participate in Federal healthcare prograirts. Insider Information and Securities Trading While is no longer a publicly listed coint'iany, one or more of its deht or equity securities may from time to time be publicly registered under the various securities laws or otheiwise have an active trading ma rket. In the course of Colleagues employment with llCA, they ma}I l'iecm'ne aware iltt?ormalion about material to an investor's decision to buy or sell the organization's securities. Non?public. material inlormatitm may include. among other things. plans for mergers. marketing strategy. linancial results. or other business (let-dings. Regardless ol? whether our securities are publicly registered or traded, colleagues may not discuss this type of" information with anyone outside of the organimtion. Within the organization, colleagues should discuss this information on a strictly ?need to knot-v" basis only with other who require this inl?ormalion to perl'orm their jobs. Securities law and policy prohibit individuals from trading in the marketable sectn?ities oi? an organization or inliuencinp; others to trade in such securities on the basis oi non-public. material information. These restrictions are n'teant to ensure the general public has complete and timely information on which to base investment decisions. r- .4513 Code of Conduct ll'an colleague obtains access to non?public, t'natcrial information about tlte organization. or any other crn'npany while performing his or herjoh, the colleague may not use that information to buy. sell. transfer, gift or effect oth transactions of securities of 11th or that other company. liven il? he or she does not buy, sell, transfer. gift or effect other transactions ot'such securities based on what he or she knows. discussing the information witlt others, such as family members. friends, vendors, suppliers, and other outside acquaintances, is prohibited ttntil the information is considered to be public. informatitn't is considered to be public twenty four hours after a general release of the information to the media. Any colleague desiring}; to purchase. sell. gift or otherwise effect a transfer of equity securities, and any llt'TA of?cer or member Board of Directors [including immediate lantin members or entities they may control) desiring to purchase. sell, gift or otherwise effect a transfer at securities ol' llCA {debt or equity]. is required to pic?clear such transfer with llCA's corporate secretary's ol'lice in advance ol' such acquisition, sale or other transl'er. License and Certi?cation Renewals Colleagues, individuals retained as independent contractors. and privileged practitioners in positions which require prol?essit?nial licenses, certi?cations, or other credentials are responsible for the current status of their credentials and shall comply at all times with Federal and state requirements applicable to their respective disciplines. To assure compliance, may require evidence of the individual having a current license or credential status. llt?A does not allow any colleague. irnlepertdenl 24 Code of Conduct contractor or privileged practitioner to work without valid, current licenses or credentials. Each colleague. have evidence of current and mild licertsure. certification. registration, accreditation or credential as required by their position description. Each facility must have appropriate processes and procedures to assure documentation of compliance with each position description requirement. Personal Use of HCA Resources It is the responsibility of each HCA colleague to preserve our organization's assets including time. materials, supplies, equipment. anti information. Organization assets are to be maintained for business? related purposes. As a general rule, the perst'nral ttse of any HCA asset without prior supervisory approval is prohibited. The occasional use of items, such as cepying facilities or telephones. where the cost. to l-lCA is insignificant. is permissible. Any community or charitable use of organization resources must be approved in advance by one's supervisor. Any use of organization resources for personal ?nancial gain unrelated to the organization's business is prohibited. Relationships Among HCA Colleagues In the normal day?to?day functions of an organization like HCA, there are issues that arise which relate to how people in the organization deal with one another. It is impossible to foresee all of these. and many do not require explicit treatment in a document like this. A few routinely arise, however. One involves gift giving among colleagues for certain occasions. While we wish to avoid any strict rules, no one shottld ever feel compelled to give a gift to anyone, and any gifts offered or received should appropriate to the circumstances. A lavish gift to anyone in a supervisory role would clearly violate organization policy. Another situation, which routinely arises, is a fund-raising or similar effort undertaken by individual coll argues. in which no one should ever be compelled to l?iar?ticipate. Similarly, when the (?tnnpany or a facility determines to support charitable orgar'tizatitnts such as the United Way. no colleague shottld be compelled to contribute to the charitable organization. nor should there be arty workplace consequences non~participation. Relationships with Subcontractors and Suppliers l-lCA is the majority owner anti managing general partner ofllealth'l?ntst l-?nrchasing (irottp [llei]. (in behalfof its entities, including llCA, negotiates contracts with supply and service vertdors. ill?fi has a Code of Conduct and Business Relationship Statement that outline its commitment to ethical and compliant behavior and its expectations of the same by its ctn'rlractors. Copies of the Code and Statement are available on website at: llf?t'i participates the l-lealthcare Group Pttr'chasing Industry Initiative as a fotnrr'ling member. This is an umbrella group of tire largest group purchasing organizations in the country intended to promote the highest standards of business conduct in these activities. Those seeking to be suppliers of should understand that virtually all oftlie system-wide procurement effort is executed. in effect, by the Purchasing Group. As in arty large organization. once central procurement decisions have been made, it is anticipated that local facilities will utilize the 25 Code of Conduct negotiated contracts. Organizations that compete unsuccessfully through l-li-?G for national agreements with or. for t-vhatever reason. eleCt not to compete in such processes. should not be disappointed by efforts of those in the [1th supply chain to maintain compliance with negotiated national agreements. We encourage those with new technologies or product innovations to be certain that l-ll?t} fully understands their *apabilitics. We must manage our consulting. subcontractor, and supplier relationships in a fair and reasonable manner. free from con?icts of interest and consistent with all applicable laws anti good business practices. We promote competitive procurement to the maximum extent practicable. Our selection of consultants, subcontractors, suppliers, and vendors will be marle on the basis of objective criteria including quality, technical excellence. price. delivery. adherence to schedules, service, and maintenance of adequate sources of supply. Our purchasing decisions will be made on the supplier's ability to meet our needs. and not on personal relationships and friendships. We employ the highest ethical standards in business practices in source selection, negotiation. determination ofcontract awards. and the administration ofall purchasing activities. We comply with contractual obligations not to disclose vendor con?dential information unless permitted under the contract or otherwise authorized by the vendor. {Tire subject of Business Courtesies, which might be offered by or to subcontractors or suppliers. is discussed on pages 28 to 30 oftltis Code.) Research, Investigations, and Clinical Trials We follow the highest ethical standards in compliance with Federal and state laws and regulations in any research. investigations, and/or clinical trials conducted by our physicians and professional staff. We do not tolerate research misconduct. which includes activities such as makng up or changing results. copying results from other studies without performing the clinical investigation or research, failing to identity and deal appropriately with investigator or institutional conflicts of interest, and proceeding without Institutional Review Board approval. Our hospitals? first priority is always to protect the patients and human subjects and respect their rights during research. investigations, and clinical trials. Physicians conducting clinical trials of investigational products and services are expected to fully inform all subjects of their rights anti r'eSponsibilitics of participating in the clinical trial. All potential subjects asked to participate in a clinical trial are given a full explanation ofaiternative services that might prove beneficial to them. They are also fully informed of potential disconrforts anti are given a full explanation of the risks. expected bene?ts. and alternatives. The subjects are fully informed of the procedures to be followed, especially those that are experimental in nature. Refusal ofa potential subject to participate in a research study or the voluntary withdrawal of his or her participation in an existing study will not his or her access to services or other bene?ts to which he or she is otherwise 26 Code of Conduct HCA entitled. A subject's voluntary infornted consent to participate in a clinical trial is documented and retained pursuant to Company and hospital policies. Atty HCA facility or colleague applyingr for or performing research of any type must follow all applicable research guidelines and privacy policies and maintain the highest standards of ethics and accuracy in any written or oral connounications regarding the research project. As in all accounting and ?nancial record?keeping, our policy is to submit only true. accurate, and complete costs related to research grants. Any HCA facility or colleague engaging in human subject research must do so in conjunction with IRB approval attd consistent with Company policies regarding human subject research and lRBs. Substance Abuse and Mental Acuity To protect the interests ofour colleagues and patients. we are committed to an alcohol and drug-free work environment. All colleagues must report for work free of the in?uence ofalcoltol and illegal drugs. Reporting to work under the influence of any illegal drug or alcohol; having an illegal drug in a colleague?s system: or using, possessing. or selling illegal drugs while on HCA work titne or property may result in termination. We may use drug tcs?ting as a to 'arts of enforcing this policy. It is also recognized individuals may be taking prescription or over?the?counter drugs. which could impairjudgment or other skills required in job performance. Colleagues with questions about the effect ofsuch medication on their performance or who observe an individual who appears to be impaired the performance of his or herjoh must immediately consult with their supervisor. Competitive Activities and Marketing Practices We operate in a highly competitive environment. Our competitive activities must conform to the high standards of integrity and fairness reflected in this Code of Conduct. The Company requires compliance with antitrust and other laws governing competitive activities, and with the Critt'tpany's written policies governing interactions with competitors. customers and suppliers. Antitrust and Unfair Competition The Company has strict restrictions on contmunicatimts with competitors. wltich are set forth in Company policy. Generally. colleagues are not to discuss with competitors non-public ?competitively sensitive topics" as defined in the policy. Because the antitrust laws are so complex and their application can depend upon the conditions iit local markets. it is not practical to adopt written policies to govern all situations. Colleagues should consult with their supervisors or the Legal Department for guidance concerning competitive activities, laws and policies relating to their areas of responsibility. Marketing and Advertising Consistent with laws and regulations that may govern such activities. we may use marketing and advertising activities to educate the public. provide information to the conmtunity. increase awareness ofour services. and to recruit colleagues. We strive to present only truthful. fully informative. and non-deceptive information in these tnaterials and annotniecments. While it is permissible to compare and contrast our services anti prices. it is against Company policy to intentionally disparage other persons or businesses based on information that is untrue. or ttot known to be true. or to intentionally interfere with another 27 Code of Conduct business's contractual and business relationships through wrongful means. This does not prevent fair, non-deceptive competition for business from those who may also have business relz-itionships with a competitor. Foreign Corrupt Practices Act The United States Foreign Corrupt Practices Act (FCPAJ requires us to exercise care in our dealings with foreign government officials, employees, or representatives; and members of their families. The FCPA prohibits providing anything of value to any of these individuals for the purpose of obtaining or retaining business. Under the FCPA, HCA is responsible for the actions of its agents and representatives. Before offering anything of value to foreign government officials, employees or representatives or a member of their family. an colleague must obtain advice from the Corporate Ethics and Compliance Department or the Legal Department. Environmental Compliance It is our policy to comply with all environmental laws and regulations as they relate to our organization?s operations. We act to preserve our natural resources to the full extent reasonably possible. We comply with all environmental laws and operate each of our facilities with the necessary permits, approvals, and controls. We diligently employ the proper procedures to provide a good environment of care anti to prevent poilution. in helping HCA comply with these laws and regulations, all HCA colleagues must understand how job duties may impact the environment, adhere to all requirements for the proper handling of hazardous materials, and immediately alert supervisors to any situation regarding the discharge of a hazardous substance, improper disposal of hazardous and medical waste, or any situation which may be potentially damaging to the environment. Business Courtesies General This part of the Code of Conduct should not be considered in any way as an encouragement to make, solicit, or receive any type of entertainment or gift. For clarity purposes, please note that these limitations govern activities with those outside of l-lCA. This section does not pertain to actions between and its colleagues or actions among HCA colleagues themselves. (See "Relationships Among HCA Colleagues" on page 25.) Receiving Business Courtesies We recognize there will be times when a current or potential business associate, including a potential referral source, may extend an invitation to attend a social event in order to further develop a business relationship. An HCA colleague may accept such invitations, provided: the cost associated with such an event is reasonable and appropriate, which. as a general rule, means the cost will not exceed $150 per person; no expense is incurred for any travel costs (other than in a vehicle owned privately or by the host. entity] or overnight lodging: and such events are infrequent. The limitations of this section do not apply to business meetings at which food (including meals] may he provided. Prior to accepting invitations to training and educational opportunities that include travel and overnight accommodations at reduced or no cost to a colleague or HCA, consult our policies and seek appropriate approvals. l-lCA colleagues may accept gifts with a total value of $75 or less in any one year from any individual or organization who has a business relationship with l-lCA. For purposes of this paragraph, physicians practicing in PICA facilities are considered to have such a relationship. Perishable or consumable gifts given to 28 a department or group are not subject to any specific limitation. HCA colleagues may accept gift certi?cates, but may never accept cash or financial instruments checks, stocks]. Finally, under no circumstances may an l-iCA colleague solicit a gift. This section does not limit: facilities from accepting gifts, provided they are used and accounted for app top riately. Extending Business Courtesies to Non-referral Sources No portion of this section. "Extending Business Conrtesies to Non-referral Sources," applies to any individual who makes, or is in a position to make, referrals to an facility. Such business courtesies are addressed in the Ericnding Business to Potential Referral Sources section of this Code anti Company policies. Meals and Entertainment. There may be times when a coileag?ue wishes to extend to a current or potential husiness associate (other than someone who may he in a position to male} a patient referral] an invitation to attend a social event (rad, reception, meal. sporting event, or theatrical event] to further or develop a business rt-rlationsl'iip. The purpose of the entertainrnent must never he to induce any favorable business action. During these events, topics of a business nature must he discussed and the host must he present. These events must not include expenses paid for any travel costs [other than in a vehicle owned privately or by the host entity) or overnight lodging. The cost associated with such an event must be reasonable and appropriate. As a general rule. this means the cost will not exceed $151] per person. Moreover, such business entertz-iinment with respect to any particular individual must he infrequent, which, as a general rule, means not more than three times per year. Consult Company policy for events that are expected to exceed $150 or were not expected to but inadvertently do exceed $150. That policy requires establishing the business necessity and of the proposed entertainment. The organization will under no circumstances sanction any business entertainment that might be considered lavish or in questionable taste. Departures from the $150 guideline are highly discouraged. Sponsoring Business Events. Also, facilities may routinely sponsor events with a legitimate business purpose (on, hospital board meetings or retreats). Provided that such events are for business purposes, reasonable and appropriate meals and ei'itertainn'ient may he offered. in addition, transportation and lodging can he paid for. However, all elements of such events. including,r these courtesy elements, must he consistent with the corporate policy on such events. 29 Code of Conduct Gifts. It is critical to avoid the appearance of impropriety when giving gifts to individuals who do business or are seeking to do business with l-lt?A. We will never ttse gifts or other incentives to improperly in?uence relationships or business outcomes. In order to avoid embarrassment, an effort should be made to ensure that any gift we extend meets the business conduct standards of tire recipient's organization. Gifts to business associates who are not government employees must not exceed $75.00 per year per recipient. Any gifts to Medicare or Medicaid beneficiaries must not exceed $10.00 per item our total more than $50.00 per year per recipient. An HCA colleague or facility may give gift certificates. but may never give cash or ?nancial instruments checks. stocks]. The corporate policy on business courtesies permits occasional exceptions to the S75 limit to recognize the efforts of those who have Spent meaningful amounts of volunteer time on behalf of HCA. US Federal and state governments have strict rules and laws regarding gifts. meals. and other business courtesies for their employees. HCA does not provide any gifts, entertainment. meals, or anything else of value to any employee of the Executive Branch ofthe Federal government or its ?scal intermediaries. except for minor refreshments in connection with business discussions or promotional items with the HCA or facility logo valued at no more than $10.00. With regard to gifts. meals. and other business courtesies involving any other category of government official or employee. colleagues must determine the particular rules applying to any such person and carefully follow them. Government Relations and Political Activities The organization and its representatives comply with all federal, state. anti local laws governing participation in government relations and political activities. As a general policy, funds or resources are not directly to individual political campaigns, political parties, or other organizations which intend to use the funds primarily for political campaign objectives. Those who seek exceptions to this general rule may only do so after obtaining the appropt'iau.? approvals required in relevant policies. Urganization include ?nancial and non-linancial donations such as using work time and telephones to solicit for a political cause or candidate or the loaning of property for use in the political campaign. The conduct ofany political action committee is to be consistent with relevant laws and regulations. in addition. political action committees associated with the organization select candidates to support based on the overall of the candidate to render meaningful public service. The organization does not: select candidates to support as a rellection ofcxpected support of the candidate on any speci?c issue. The organization engages in public policy debate only in a limited number of instances where it has special expertise that cart inform the public policy formulation process. When the organization is directly impacted by public policy decisions. it may provide relevant. factual information about the impact of such decisions on the private sector. In articulating positions. the organization only takes positions that it 30 Code of Canducr 31 Code of Conduct believes can be shown to be in the larger public interest. The organization encourages trade associations with which it is associated to do the same. it is important to separate personal and corporate political activities in order to comply with the appropriate rules and regulatitms relating to lobbying or attempting to in?uence government officials. No use of corporate resources. including e?mail, is appropriate for personally engaging in political activity. A colleague may, ol? course. participate in the political process on his or her own time and at his or her own expense. While doing so, it is important HCA colleagues not give the impression they are speaking on behalf of or representing HCA in these activities. Colleagues cannot seek to be reimbursed by i-iCA for any personal contributions for such purposes. At times, HCA may ask colleagues to make personal contact with government of?cials or to write letters to present ottr position on specific issues. in addition, it is a pan of the role of some management to interface on a regular basis with government oi'iicials. li? a colleague is making these communications on behali? ol' the organization. he or she must be certain to be familiar with any regulatory constraints anti observe them. Guidance is always available from the Corporate Govemrnent Relations and Legal Departments as necessary. To obtain further guidance on an ethics and compliance issue or to report a suspected violation of our Code of Conduct: 0 DISCUSS the situation with your supervisor; DISCUSS the situation with a member of local management or your local Ethics and Compliance Of?cer; or 0 CALL the Corporate Ethics Line at 1-800-455-1996. The Company?s Ethics anti Compliance Program Program Structure The Ethics and Compliance Program is intended to demonstrate in the clearest possible terms the absolute commitment of the organization to the highest standards ol? ethics and compliance. The elements of the program include setting standards (the Code and Policies and Procedures], communicating the standards, providing a mechanism for reporting potential exceptions. monitoring and auditing, and maintaining art organizational structure that supports the furtherance of the program. Each of these elements is detailed below. These elements are supported at all levels ol? the organization. Providing direction, guidance and oversight are the Audit and Contpliance Committee of the Board oi? Directors; the Corporate Ethics and Compliance Steering (.iommittee consisting of senior management; anti the Corporate Ethics and Compliance Policy Committee consisting of senior management and representative i'acility CliUs. The Chief Ethics and Compliance Of?cer for the organization and the Ethics and Compliance Department are responsible for the day?to?day direction and implementation 01" the Ethics anti Compliance Program. This includes developing resources (including policies and procedures. training programs, and communication tools] for and providing support (including operating the Ethics Line, conducting program assessment, and providing advice! to Facility ECOs and others. Responsible Executives are individuals in the Corporate Of?ce who have expertise in various areas oi" compliance risk and who are called upon in their areas ot?cxpertise to lead policy anti training development efforts, conduct monitoring arid auditing as 32 Code of Conduct appropriate, anti provide advice. Playing a key role in ensuring;r the successful implementation of our Ethics and Compliance l-?rogram. Facility ECOs are responsible for distributing standards. ensuring training is conducted. conductint,t monitoring and responding to audits, investigating and resolving Ethics Line cases, and otherwise administering the Ethics and Compliance Program in their facilities. llospital ECOs are also expected to establish and maintain a Facility Ethics artd Cotnpliance Committee to assist them in these efforts. All Divisions and Markets have appointed Division or Market liCOs, who assist in directing and assessing the Ethics and Compliance Program for their Divisions or Markets. Another important resource wlto may he alile to address issues arising out of this Code of Conduct is the Human Resources Manager. Human Resources Managers are highly knowledgeahle about many of the compliance risk areas in this Code of Conduct that pertain to employment and the workplace and are responsible for ensuring compliance with various employment laws. If a concern relates to specific details ofan individuals work situation, rather titan larger issues of organizational ethics and compliance, the Human Resources Manager is the most appropriate person to contact. in that we promote the concept of management autonomy at. local facilities, evcty effort should be made to resolve workplace conduct and employment practice issues throth the individuals supervisor and the Human Resources Manager at the local facility. Experience has shown that this is an effective and productive way to 'ttl with these ntatters. Division Human Resources Managers also assist in investigating and resolving?f lithics Line cases and workplace conduct and employment practices issues. HCA routinely reviews the operatitm of this problem solving procedure and may periodically modify the details of the approach itt order to maximize its cffeCtiveness. in circumstances where you seek to utilize the problem solving procedure. we encourage you to inquire about the specilics of how the procedure operates. Your local human resources department or represetItative can provide this information. All of these individuals or groups are prepared to support colleagues in meeting-3r the standards set forth in this Code. lists for each of the Corporate entities and the Facility liCUs can be found at the [Ethics and Compliance site on the organization's Intranet. Setting Standards With respect to our Ethics and Compliance Program, we set standards through this Code of Conduct, ethics and compliance policies and procedures and. occasionally, tl'trough other guidance mechanisms, such as Cornpliance Alerts and advisory It is the responsibility of each irtdividttal to be aware of those policies and procedures that pertain to his or lter work and to follow those policies and procedures. 33 Code of Conduct Training and Communication Comprehensive training and education has been developed to that colleagues throughout lite organization are aware of the standards that apply to them. Code of Conduct training is conducted at the time art individual joins the organization and annually for all colleagues. Compliance training in areas of contpliance risk billing, coding, cost reports] is required of certain individuals. Company policies outline the training requirements. All ethics and compliance training is required to be recorded in the Company's learning management system. the Learningf Center ?11.0. Through the HHS, system administrators and ECt'ls track colleagues compliance with their training requirements and report such information as necessary. Many resources regarding our program are available to all HCA colleagues on our Intranet and to the general public on the Internet. We encourage all colleagues to frequently visit both sites. Resources for Guidance and Reporting Concerns To obtain guidance on an ethics or compliance issue or to report a concern, individuals may choose from several options. We encourage the resolution of issues. including human resources?related issues payroll. fair treatment and disciplinary issues). at a local level. Colleagues should use the human resources-related problem solving procedure at their facility to resolve such issues. it is an expected good practice, when one is comfortable with it and think it appropriate under the circumstances. to raise concerns first with one's supervisor. If this is uncomfortable or inappropriate. the individual may discuss the situation with the Facility Human Resources l'vianager, the Facility ECG, or another member of management at the facility or in the organization. Individuals are always free to contact the Ethics Line at l-tititl-4?35?i99o. IICA makes every effort to maintain, within the limits of the law, the con?dentiality of the identity of any individual who reports concerns or possible misconduct. There is no retribution or discipline for anyone who reports a concern in good faith. Any coll raguc who deliberately makes a false accusation with the purpose of harming or retaliating against another colleague is subject to discipline. Personal Obligation to Report We are committed to ethical and legal conduct that is compliant with all relevant laws and regulations and to correcting wrongdoing wherever it may occur in the organization. Each colleague has all individual responsibility for reporting any activity by any colleague. physician. subcontractor. or vendor that appears to violate applicable laws. rules, regulations. accreditation standards, standards of medical practice, Federal conditions of participation. or this Code. if a ntatter that poses serious compliance risk to the organization or that involves a serious issue of medical necessity, clinical outcomes or patient safety is reported locally. aan if the reporting individual doubts that the issue has been given sufficient or appropriate attention. the individual should report the matter to higher levels of management or the Ethics Linc until satis?ed that the full importance of the matter has been recognized. lfa matter that poses concern regarding tlte safety or quality of care provided to a patient irt the hospital is identified and was reported locaily but thought to be unresolved, an additional avenue for reporting is available through noti?cation to The Joint Commission. There will be no retaliatory disciplinary action taken against an employee who reports concerns to The Joint Cotnmissirm. 34 Code of Conduct Internal Investigations of Reports W- are committed to investigating all rcportcd concerns and con?dentially lo the extent possible. The Chief Ethics and Ctmipliance Officer coordinates any findings from corporate?led investigations and immediately corrective action or changes that need to he made. expect all colleagues to cooperate with investigation efforts. Corrective Action Wher? an internal investigation substantiates a reported violation. it is the policy of the organization to initiate corrective action, including. as appropriate. making prompt restitution of any overpayment amounts, notifying the appropriate govermnental agency. instituting whatever disciplinary action is necessary. and implementing systemic changes to prevent a similar violation from recurring in the Discipline All violators of the Code will he subject to disciplinary action. The precise discipline utilized will depend on the nature, severity, and frequency of lhe violation and may result in any or all of the following disciplinary actions: Oral warning; Written warning; Written reprimand; SuSpension; Tennination; and/or Restitution. Measuring Program Effectiveness We are committed to assessing the effectiveness of our Ethics and Compliance Program through various efforts. Much of this effort is provided hy the internal Audit Departmem. which routinely comlucts internal audits of issues that have regulatory or compliance implications. Responsible Executives routinely undertake monitoring efforts in support of policies and compliance in gei'iet'al. Facilities conduct self?monitoring. and the [Ethics and Compliance Department conducts reviews of facility ethics and compliance programs designed to assess facility implementation of the Code, policies and procedures. lithics line and related investigations. and o'zonitorint,f efforts. These compliance process reviews permit the Ethics and Compliance Department to identify and share best practices. Most of these methods of assessment result in reports of findings by the reviewers and correctiv action plans by the facilities that are reviewed. 'l?hrougl'i these reviews. we are continuously assessing the effectiveness of the Program and finding ways to improve it. Acknowledgment Process requires all colleagues to Sign an con?rming they have reviewed the Code, understand it represents mandatory policies of and agree to ahide hy it. New colleagues are required to sign this acknowledgment as a condition of employment. liach lltf?A colleague is also required to participate in annual Code of Conduct training, and records of such training must he retained by each facility. Adherence to and suppon of llt?A'a Code of Conduct and participation in related activities and training is considered in decisitn'is regarding hiring. promotion, anti cornpensalirm for all candidates and colleagues. New colleagues must receive Code of Conduct trainingr within 30 days of employment. 35 . nll?? {Onllne Version] ase cut keep this wallet card with you at all times. I) Missmn and Values Statement Above all else. we are committed to the care and improvement ol? human life. In recognition of this we will strive to deliver high quality, cost-effective healthcarc in the we serve. In pursuit of our mission. we believe the Following value statements are essential and timeless: I We recognize and q?inn the unique and intrinsic worth of each individual. I We treat all those we seri'c lt?liil Compassion and kindness. I We act trill: absolute honesty. unrljitirness in the li't? conduct our business and the not: the live our lines. I We ll'ltSf our colleagues as members of our from and pledge to {rent one another with respect. and dignity rct's For regulatory questions related to coding,r or billing contact the Helpline hy c?mnil n! Regs Helpline. Universal ID (8.9., 3?4 or Social Security Number (as listed in personnel records) Signature Printed Name Department Facili Date To get help with an L'liliCS or compliance concern or to report a potential violation of our Code of Conduct. contact your supervisor. another member of local management. your facility Ethics and Compliance Officer or the Ethics Line: .996. I agree to the HCA Code of Conduct and understand it represents mandatory policies of the I certify that have reviewed organization. Acknowledgment Card abide by the Code. Please cut all, Fold and keep this wallet card with you at all timesL2: Acknowledgment Card HCA