UCSD HEALTH SCIENCES - COMPLIANCE OFFICIALS AND PHONE NUMBERS

1. UCSD will bill only for services actually rendered and shall seek the amount to which UCSD is entitled. Under no circumstances will UCSD tolerate billing which misrepresents services actually rendered. Patients may request services that fail to satisfy the medical necessity criteria or are not a covered benefit under the patient's insurance.
2. Supporting medical documentation must be prepared for all services rendered. UCSD employees shall bill on the principle that if the appropriate and required documentation has not been provided, then the service has not been rendered.
3. All services must be accurately and completely coded and submitted to the appropriate payer in accordance with applicable regulations, laws, and contracts and campus policies and procedures. Federal and state regulations take precedence; however, campus policies and procedures must accurately reflect those regulations. Professional coding and documentation will be consistent with the standards established in the UCSD Compliance Program and relevant policies.
4. All patients shall be consistently and uniformly charged. Discounts will be appropriately reported and items and services consistently described so that comparability can be established among payers. Government sponsored payers shall not be charged in excess of the provider's usual charges. Any questions regarding the interpretation of this standard should be directed to the CCO or University General Counsel.
5. Billings and collections will be recorded in the appropriate accounts. Credit balances must be processed in a timely manner in accordance with applicable rules and regulations. When the cost report process identifies any credit balances, UCSD employees shall direct those issues to other personnel responsible for patient accounts.
6. When ordering or providing services or items, UCSD physicians (or other health care professionals authorized by law to order items or services) shall only order those services and items that are that are consistent with generally accepted medical standards for diagnosis or treatment of disease and are determined by the profession to be medically necessary medically and appropriate. Payers will only reimburse for covered benefits of the patient’s private or governmental plan and for those services and items the payer deems are medically necessary or appropriate. In some cases, a health care professional may determine that services are medically necessary or appropriate, but the patient’s health plan may not cover those services. In those cases, a patient should refer to his or her health plan administrator to receive information about the process for disallowed claims or uncovered benefits.
7. Patients may request services that are not covered benefits. Such services may be provided as long as the patient has been given advance notice and has agreed to pay for the services. In these cases, the patient may request the submission of a claim for the services to protect his or her appeal rights with respect to those services or to determine the extent of the coverage provided by the payer.
8. Elective procedures that are not covered by governmental or private payer can be provided. However, before providing any elective services, the provider must inform the patient that these services may not be covered. The provider should obtain the patient's agreement to pay for these services if the payers deny the claim. A patient has the right to have a claim submitted even if the services are excluded from coverage.
9. UCSD personnel should be aware of the existence of the UCSD Professional Fee Billing Guidelines and Clinical Laboratory Billing Guidelines. These Guidelines provide for the policies and procedures to be followed when billing payers for professional fees and laboratory services. The UCSD guidelines are available in the Compliance Office.
10. UCSD personnel responsible for coding, billing and documentation should be knowledgeable about UCSD policies and procedures, federal and state regulations regarding those activities. UCSD faculty, administrators and staff are individually responsible for those parts of the process under their control. UCSD shall provide all personnel involved in coding, billing, documentation and/or the submission of charge or billing data with opportunities for training. Appropriate training should cover those coding and documentation practices that enable the individual to accurately code, document, and bill according to federal and state regulations and UCSD’s policies and procedures. Management should ensure that appropriate evaluation processes have been established in order to assess whether UCSD personnel understand and carry out correct procedures.
11. An accurate and timely billing structure and medical records system is critical to ensure that UCSD personnel can effectively implement and comply with required policies and procedures. Demonstrated lapses in the information and billing systems infrastructure should be remedied in a timely manner by the campus executive management team, other designated UCSD personnel and billing entities.
12. In preparing cost reports, all costs will be properly classified, allocated to the correct cost centers, and supported by verifiable and auditable data.  Cost reports will be submitted in a timely and accurate manner. It is UCSD policy to correct any cost report preparation or submission errors and mistakes in a timely manner and, if necessary, clarify procedures and educate employees to prevent or minimize recurrence of those errors.
13.  Costs of drugs, devices and supplies must be properly accounted for.  Education, research or other grants or gifts from companies given in lieu of a discount are prohibited.

5. CLINICAL RESEARCH

Standard:  The rights of research study participants and their well being and privacy are protected by UCSD through our compliance with ethical standards and all applicable UC policies and federal and state regulations.

 Policy:

 a.     UCSD policies provide local guidance for compliance with federal, state and University of California (UC) standards that ensure the integrity of research programs.  These policies address pertinent issues, including protection of the rights and safety of research subjects, possible conflicts of interest and/or commitment, regulatory non-compliance, scientific misconduct and procurement integrity.  These policies are communicated to faculty, staff, students, volunteers and contractors.  Ongoing training programs help to ensure that personnel are informed of new or revised regulations and policies.  In addition, procedures have been established and are publicized to allow individuals to raise concern about non-compliance.

b.    Protection of the rights, well-being and privacy of research subjects and of the integrity of all research is ensured through an Institutional Assurance filed with the NIH Office of Human Research Protection and through UCSD interactions with and oversight by the Food and Drug Administration, the Office of Research Integrity and other federal and state agencies.  The Assurance describes the UCSD Institutional Review Board activities pertaining to protocol review, the informed consent process, research monitoring and the reporting and review of unexpected serious adverse events that may occur in the course of the research study.

c.        The UCSD Office of Contracts and Grants Administration (OCGA) and the Central Clinical Trials Office (CCTO) in the Office of the Dean, School of Medicine, provide oversight for contracts, grants and clinical research proposal activities to ensure program compliance with the Office of Budget and Management (OMB) Circular A-21, A-110 and/or standards of other sponsoring agencies.  These, as well as departmental and other business offices, provide the fiscal administration and oversight needed to ensure that research budgets and cost allocation practices comply with federal, private sponsor and UC regulations and guidance.  The UCSD Healthcare billing operations and systems, periodically monitored by the CCTO, the Compliance Office and Audit & Management Advisory Services (AMAS), incorporate processes and procedures to ensure that research costs are appropriately charged to sponsors and/or to third parties.  Where appropriate, issues identified during monitoring and auditing of cost transfers, billing and cost allocation practices result in changes in policy and/or procedures, or in other corrective or disciplinary activities.

 d.       In accordance with UCOP Operating Requirement No. 95-5, “Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects”, the cost to perform clinical trials conducted for a private sponsor must always be fully funded by the sponsor and may not be supported in whole or in part by other funds, including third party insurance payments, gift or foundation funds or charges to the subject.  This requirement does not apply to trials supported by government or intramural funds.  For devices that are being tested in a clinical trial and where an Investigational Device Exemption (IDE) Category B has been granted (under federal regulation 21 CFR 812.7 (b) or similar regulatory sections), the sponsor may charge for the device.

 e.        Under some circumstances, Medicare and Medi-Cal will cover the routine costs of care of subjects participating in a clinical trial, as well as the costs associated with the diagnosis and treatment of conditions arising out of the subject’s participation in the trial.  The Central Clinical Trials Office in the Office of the Dean, School of Medicine has implemented procedures to ensure compliance with these coverage policies.

 f.         Goods and services are procured in a competitive, fair and timely manner in compliance with OMB Circular A-110 and UC policies.  Conflicts of interest are avoided.  Educational or research grants or other funds received from commercial entities are not permitted to influence procurement decisions.

 g.       Clinical research record retention standards ensure that documents and other supporting evidence are maintained as required by federal and other regulations.

 h.       The Institutional Review Board, principal investigators and the UCSD Healthcare Health Information Management Services are responsible for ensuring the privacy of protected health information, as specified in the regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

 Question:  A patient hospitalized on my unit is on a research study and expressed concerns about the safety of the study treatment.  As a nurse, I do not feel I can answer these questions.  What should I do?

 Answer:  The Principal Investigator has a responsibility to answer such questions as part of the informed consent process.  This may have occurred and the patient does not remember or did not raise the questions at that time.  You should contact the Principal Investigator and ask that he/she meet with the patient.  If you are reluctant to raise the issue, you should ask your supervisor to do this.  If the patient is reluctant to meet with the Principal Investigator or a member of the research team, you should inform the attending physician and the UCSD Human Research Protections Program at (858) 455-5050.  The patient should be aware that they can withdraw from study participation and not jeopardize the medical care they receive from UCSD.

 Question:  I believe a faculty member has exerted improper pressure on a patient to undergo an experimental procedure because the Principal Investigator has a financial interest in the outcome of this research study.  What should I do?

 Answer:  Under all circumstances, it is improper for a patient to be pressured to participate in a research study.  The UCSD Human Research Protections Program (858-455-5050) should be notified.  Further, if the Principal Investigator does have a personal financial interest in the outcome of the research, this may be a violation of UCSD Conflict of Interest Policy.  You should report your concerns to the Conflict of Interest Office (858-534-6465), to the Dean for Academic Affairs (858-534-4877) or to the Compliance Officer (619-471-9028).  If you wish to remain anonymous and protect your privacy, you can use the UCSD Hotline, which is operated by an outside agency and is set up to accept anonymous queries like this (877-319-0265).

 Question:  In reviewing a patient’s chart, I noticed that a faculty member ordered an experimental medication. I can find no documentation that an informed consent has been signed nor that the patient is enrolled in a study.

 Answer:  The study information and a copy of the informed consent should be part of the medical record.  You can determine if there is an approved study by accessing the Central Clinical Research Compliance intranet web page (http://www-.ucsdhealthcare.ucsd.edu/researchcompliance).  The consent may have been obtained and not properly filed or the patient may not be enrolled in a study.  E