Part 2 -

Compliance with Legal and Ethical Standards Black-Schaffer & Johnson

MGH PATHOLOGY SERVICE Compliance with Legal and Ethical Standards A. Policy The MGH Pathology Service is committed to ensuring that all professional staff members and employees (1) are aware of and comply with the letter and spirit of all applicable laws and regulations, (2) avoid conflicts of interest and (3) conduct hospital business with the highest degree of integrity and honesty. This plan describes the MGH Pathology Service program to ensure compliance with all laws, regulations and policies and outlines the mechanism used to monitor compliance. The MGH Pathology Service will undertake the following with the assistance and guidance of the Hospital Compliance Director and the Office of the General Counsel. B. Applicability This policy applies to all employees of the MGH Pathology Service and consultants retained in its service. This policy encompasses all relevant areas of law, regulation and business practice, including but not limited to: antitrust, conflict of interest, clinical practice discrimination, environmental protection, financial practices, gifts, mandated reporting, Medicare and Medicaid referral and billing practices, Occupational Health and Safety, Health Information Protection and Privacy, pharmaceutical practices, taxation, grant administration and scientific integrity. C. Plan 1. Organization The MGH Pathology Service will: Establish compliance oversight as an integral function of the Pathology Executive Committee (PEC). This committee meets monthly, chaired by the Chief of the Pathology Service. It includes the Associate Chiefs of Anatomic Pathology, Laboratory Medicine, Molecular Pathology and Research, Training and Education, and Clinical Operations. It also includes the Director for Finance and Administration who is designated as the Department's Compliance Officer. The PEC will: Communicate its commitment to compliance to all employees Monitor department compliance and report to the Compliance Oversight Committee Establish and review enforcement of appropriate compliance standards, policies and procedures Designate the Departmental Compliance Officer to work with individual laboratories to ensure compliance by all employees. The Director of each laboratory or service area in the MGH Pathology Service is responsible for the implementation of all compliance procedures within their operation. The Compliance Officer, or his or her designee, will: Establish a departmental Billing Compliance committee to monitor professional and technical billing activity for appropriateness, timeliness and accuracy Compile and maintain all statutory and regulatory requirements, industry standards and internal policies applicable to the MGH Pathology Service Work with Laboratory Director to develop compliance procedures for their respective areas Develop a system to communicate statutory and regulatory requirements to the Laboratory Director Encourage and enable all employees to report any possible noncompliant activities to the Department or Hospital compliance Director without fear of retaliation. Evaluate and investigate all reports of noncompliance using appropriate institutional resources. When required, refer matters to the PEC, Office of General Counsel or Hospital Oversight Committee Take remedial steps to correct and prevent recurrence of instances of noncompliance, recommend appropriate disciplinary action to the PEC, Laboratory Director or other appropriate body. Monitor the effectiveness of the Department's compliance program, implement changes when necessary and report on compliance activities to the PEC on an annual basis. Develop and implement additional policies and procedures to ensure continued compliance with applicable laws, regulations, standards and policies. Establish an education program to inform all current staff members and train new employees at orientation concerning Departmental compliance policies, procedures, their obligation to report any questions concerning compliance, and all departmental and organizational reporting mechanisms. Develop a communication system to periodically advise staff of new statutory, regulatory or institutional requirements 2. Communication The MGH Pathology Service will: Communicate its commitment of compliance to all its employees as part of annual competency training. Work in conjunction with the MGH Compliance Office to develop a communication system to periodically advise the Hospital community and its external customers of current compliance requirements. This will include: Definition of the Medicare medical necessity policy as it relates to laboratory studies Components of test profiles CPT or HCPCS codes used to bill each profile Medicare payment for each profile and component Hospital billing practices for profiles Health Information Privacy Protection Develop a communication system to provide compliance and ethics training for all MGH Pathology Service staff, particularly those involved in billing, marketing, specimen collection test processing and reporting. This training will be scheduled annually and as determined by changes in relevant laws or regulations. The training will: review the hospital and laboratory compliance policies, reinforce the expectation of compliance with all regulatory standards as a condition of employment, describe the hospital communication system for the internal reporting of compliance questions and acceptable standards of conduct. 3. Monitoring and Auditing The MGH Pathology Service will: Audit existing laboratory operations to ensure compliance with the laboratory policies and procedures related to billing, sales, marketing, notices to physicians, requisitions and the ordering of laboratory tests. Review the laboratory plan and all applicable Federal and State laws to ensure compliance with standards for contracts, marketing, billing, sales and record keeping. Analyze test utilization data annually to monitor test-ordering patterns and investigate any significant volume increases to ensure compliance with all established policies. Report findings to the hospital Compliance Oversight Committee 4. Procedures and Policies The MGH Pathology Service will Develop specific written procedures and policies including: Standards of conduct which address laboratory policies regarding fraud and abuse, as well as disciplinary actions that may be undertaken for employees failing to comply with these policies. Methods for investigating, documenting, correcting and reporting all systems, operations and personnel compliance failures. Billing policies that ensure the accurate and correct coding of all services Policies for ordering laboratory tests that address the use of only medically necessary tests and the use of standing orders in the course of extended treatments. The MGH Pathology Service will review all fraud alerts and communications from the HHS OIG and its Fiscal Intermediary and consult with the Hospital Compliance Director and the Office of General Counsel. The MGH Pathology Service will evaluate any practices outlined in a fraud alert. This may include monitoring any portion of the operation identified in the alert. The MGH Pathology Service will develop clear and accurate descriptions of its services, which include information on the impact of ordering practices for all payers including Medicare. The MGH Pathology Service will maintain fair and consistent billing practices for all payers, in accordance with pricing policies and models established by the Hospital Finance Department. Specifically, charges for all panels will reflect the total cost of all tests included in that panel. The MGH Pathology Service will establish or maintain records as required by all Federal or State laws, and hospital policy. The job descriptions and annual evaluations for all managers will include performance criteria related to the promotion of and adherence to all elements of the Hospital and Department compliance plans. 5. Investigation All reports of violations of the hospital or laboratory legal and ethical standards will be promptly investigated. This investigation may include interviews with appropriate personnel, review of relevant documents, and laboratory reports. If it is determined that violations have occurred, the hospital administration will take the necessary actions to rectify the event(s), secure the relevant evidence, report the events to all necessary internal and external agencies, and institute appropriate corrective for all individuals involved in the misconduct. 6. Corrective Action The MGH Pathology Service will initiate appropriate corrective and/or disciplinary action against any employee who fails to comply with the Hospital or Laboratory compliance policies, federal or State laws, or acts to compromise the integrity of the organization. This will be conducted with the Hospital Department of Human Resources and will be consistent with hospital policies and procedures. References: American Medical Association. Current Procedural Terminology (CPT™) 2006. Chicago, IL: AMA Press: 2005 Black-Schaffer WS, Young RH, Harris NL. Subspecialization of surgical pathology at the Massachusetts General Hospital. Am J Clin Pathol 1996 Oct;106(4 Suppl 1):S33-42 Colgan TJ, Frable WJ. The cytopathologist: workload, regulations, and the forgotten professional. Diagn Cytopathol 1997 Nov;17(5):313-4 College of American Pathologists. Compliance Guidelines for Pathologists. 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Medicare Program Final Rule, Department of Health and Human Services (DHHS), Centers for Medicare & Medicaid Services (CMS), 42 CFR Parts 400, 405, and 426 [CMS-3063-F], Date: OCTOBER 30, 2003, RIN 0938-AK60, SUBJECT: Review of National Coverage Determinations and Local Coverage Determinations. www.cms.hhs.gov/regulations/coverage/3063f-10-30-03.pdf Medicare Program Integrity, Department of Health and Human Services (DHHS), Manual System Department, Centers for Medicare & Medicaid Services (CMS), Transmittal 63, Date: JANUARY 23, 2004, CHANGE REQUEST 3010, SUBJECT: Benefit Improvement Protection Act (BIPA), Pub. 100-08 Medicare. www.cms.hhs.gov/manuals/pm_trans/R63PI.pdf Medicare Program Memorandum, Department of Health and Human Services (DHHS), Carriers, Centers for Medicare & Medicaid Services (CMS), Transmittal B-01-61, Date: SEPTEMBER 26, 2001, CHANGE REQUEST 1724, SUBJECT: ICD-9-CM Coding for Diagnostic Tests. Medicare Program Memorandum, Department of Health and Human Services (DHHS), Intermediaries, HEALTH CARE FINANCING ADMINISTRATION (HCFA), Transmittal A-00-43, Date: JULY 27, 2000, CHANGE REQUEST 1192, SUBJECT: Advance Beneficiary Notices (ABNs) for Services for Which Institutional Part B Claims Will be Processed by Fiscal Intermediaries. Medicare Program Memorandum, Department of Health and Human Services (DHHS), Intermediaries/Carriers, HEALTH CARE FINANCING ADMINISTRATION (HCFA), Transmittal AB-00-116, Date: NOVEMBER 24, 2000, CHANGE REQUEST 1021, SUBJECT: Local Medical Review Policy (LMRP) Development and Format. Medicare Program Memorandum, Department of Health and Human Services (DHHS), Intermediaries/Carriers, HEALTH CARE FINANCING ADMINISTRATION (HCFA), Transmittal AB-00-73, Date: AUGUST 11, 2000, CHANGE REQUEST 1309, SUBJECT: Proper Billing of Outpatient Pathology Services under the Outpatient Prospective Payment System (OPPS). Office of Inspector General, HHS, 06/27/01 Special Advisory Bulletin: Practices of Business Consultants. http://oig.hhs.gov/fraud/fraudalerts.html Office of Inspector General, HHS, Publication of the OIG's Final Compliance Program Guidance for Individual and Small Group Physician Practices (65 FR 59434; October 5, 2000). http://www.os.dhhs.gov/oig/oigreg/physician.htm Office of Inspector General, HHS, Publication of the OIG's Provider Self-Disclosure Protocol [Federal Register: October 30, 1998 (Volume 63, Number 210)] [Notices] [Page 58399-58403]. From the Federal Register Online via GPO Access [wais.access.gpo.gov]. [DOCID:fr30oc98-95] Office of Inspector General, HHS, Publication of the OIG's Special Fraud Alerts [Federal Register: December 19, 1994]. http://www.os.dhhs.gov/oig/frdalrt/121994.html Parham DM. The hidden increase in histopathologists' workload. J Clin Pathol 1996 Aug;49(8):689-90 Practice Management Information Corporation. 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