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State law requires authorized prescribers of medication to consult the CURES database before prescribing Schedule III or Schedule IV controlled substance(s) for the first time to an (outpatient) patient and at least once every four months if the prescribed substance remains part of the patient’s treatment.
If a patient has an existing prescription for a Schedule II or Schedule III controlled substance, the provider may not prescribe additional controlled substances until the provider determines a legitimate need.
The CURES database does not need to be consulted for inpatients or hospice patients. Please visit State of California, Department of Justice, Office of the Attorney General website FAQs website for additional information to register and access the CURES 2.0 database. The website for registration and access is found at:
https://oag.ca.gov/cures/faqs
For additional guidance navigating the CURES 2.0 database, please reference the following user guide: https://oag.ca.gov/sites/all/files/agweb/pdfs/pdmp/cures-2.0-user-guide.pdf
Kwashiorkor is often miscoded based on incomplete documentation or it is erroneously selected from other malnutrition codes. The Office of Inspector General (OIG) reviews have identified inappropriate payments to hospitals and physicians for claims with Kwashiorkor diagnosis.
Kwashiorkor is a form of severe protein malnutrition. It generally affects children living in tropical and subtropical parts of the world during periods of famine or insufficient food supply. It is typically not found in the United States.
When selecting this malnutrition diagnosis, please make sure that the diagnosis is adequately supported by documentation in the medical record. Specifically, physician clinical documentation must support the type of malnutrition. Clinical evidence that supports the diagnosis of malnutrition includes signs and symptoms, findings and treatments.
The Centers for Medicare & Medicaid Services (CMS) requires a non-physician/practitioner signature for all medical documentation.
The signature
Members of the UCLA Health Sciences’ community are strongly encouraged to report known or suspected violations of policies, this UCLA Code of Conduct, or any federal, state, or local law(s). This includes violations of patient care and personal conduct that conflicts with UCLA Health Science policies. There are a number of ways to report concern(s), known or suspected violation(s):
We recommend you visit our FAQ section for information on this topic.
The UCLA Code of Conduct advises university personnel that they have a duty to act solely in the best interest of the organization and its patients. This means that each personnel should not engage in activities that result in a gain or profit for oneself or others at the expense of the organization or that interfere with work duties or judgment. Conflicts of interest may occur if personal activities or interests could influence one to make decisions that are not in the best interests of UCLA Health.
When scheduling a service in CareConnect, it is critical to select the location where the services will actually be performed. Otherwise, claims billed to insurance will reflect an incorrect place of service code and will result in an erroneous payment. Payors may pay different rates for different places of service.
If the location where you perform a service is not set-up in CareConnect, please contact the clinical department CAO/MSO for assistance.
It is critical to accurately report the place of physician services to prevent overpayments, denials or possible "false claim" which could result in monetary penalties and other actions by enforcement agencies. Different requirements and possibly payments apply to different places of service. For example, physician professional fees are reimbursed at a higher rate when performed in an office setting to cover the overhead expense incurred by the physician/group.
The National Provider Identifier (NPI) is a unique 10-digit number required for any health care provider (i.e. physicians, non-physician practitioners) and/or organization (i.e. hospitals, Ambulatory Surgery Centers) that submits health care claims to a health plan(s). The NPI is a once a life-time assignment and provides information about the individual/organization such as address and specialty. The NPI is a national standard under the Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplifications provisions.
UCLA's Legal Medical Record Standards Policy (HS 6420) states, "A signature identifies the author or the responsible party who takes ownership of and attests to the information contained in a record entry or document."
No, it is against policy to use Health System or University accounts to pay for personal obligations such as copayment for personal doctor's office visit or any other obligations of a personal nature. The Health System and the University expect the workforce to use resources of the organization for the business of the organization only.
Medicare has devised a set of procedures that can only be paid if performed in an inpatient setting. The patient is discharged on the same day. These inpatient-only procedures, also referred to as the C-List (procedures assigned with status indicator “C”), are updated annually and require an admission order prior to performance of such procedure(s).
The designation of inpatient-only list by Medicare requires an inpatient admission for payment even though the provider may feel the procedure can be safely performed in an outpatient setting.
You may visit CMS website for the most recent and updated inpatient-only procedure list.
Noridian Healthcare Solutions is California’s Medicare Administrative Contractor (MAC) that covers both Hospital Services (Part A) and Professional Services (Part B). Noridian’s representatives have confirmed that if a hospital service is denied they will also recoup payments for related professional services if those services are impacted based on the reason the hospital service was denied.
Drugs are billed based on units, not the total number of milligrams. Example, if the quantity administered is 300mg and the description of the drug code is 10 mg. the units billed should be thirty (30). The documentation of actual quantity administered to a patient, based on a physician order, is converted to the correct units for proper billing.
The Office of Inspector General (OIG) recently issued a report that discusses compliance concerns related to electronic health record (EHR). One of those issues is the copy and paste functionality. The link to the complete OIG report is http://oig.hhs.gov/oei/reports/oei-01-11-00570.asp.
EHRs provide many advantages and unique functions such as the ability to copy-paste or copy-forward function to expedite documentation. This function should be used with caution to assure the documentation for a particular encounter is unique to that encounter by reflecting problems addressed and services provided to the patient at that time. Improper use of this function could lead to errors in care or diagnosis of a patient and inaccurate information in the medical record particularly if used between different patients. The OIG, in its report, stated: “…. inappropriate copy-pasting could facilitate attempts to inflate claims and duplicate or create fraudulent claims” All of these factors could also lead to inaccurate billing of services and potential HIPAA violations.
For more information, see UCLA Hospital System Policy - Legal Medical Record Standards http://www.mednet.ucla.edu/Policies/pdf/enterprise/HS6420.pdf
Documentation of patient care is critical for communication amongst healthcare providers. To facilitate true, complete and accurate charting of patient care in the world of EHR provider can do the following:
The Medicare law requires admission order completed by a physician with admitting privileges and knowledge of the patient’s condition(s). Payment for inpatient hospital services is dependent on the presence of admission order.
42 C.F.R 482.12(C) (2)
“Patients are admitted to the hospital as inpatients only on the recommendation of a physician or licensed practitioner permitted by the state to admit patients to a hospital.”
A patient may have many conditions or problems at admission. However, the principal diagnosis is the condition that caused the patient to be admitted to the hospital for care. Any other conditions the patient has should be recorded and would be considered secondary.
According to the Federal Anti-kickback laws and UCLA Health System Conflict of Interest Policy (HS 9009), no employee including faculty should accept gifts and/or payments in cash or in kind from vendors or other third parties doing business (or seeking to do business) with the University, except as compensation for bona fide services allowed by University policy.
Examples of such items include, but are not limited to: pens, notepads, free meals and free tickets to events. In particular, invitations from pharmaceutical representatives to off-campus complimentary lunches or dinners should be declined in accordance with HS 9009 and the PhRMA Code of Conduct. Pharmaceutical representatives should be directed to the Office of Continuing Medical Education if they wish to sponsor continuing medical education events that include complimentary lunches or dinners at an off-campus location.
For additional information, please contact Joyce Fried, Assistant Dean who is the chair of the Industry Relations Committee. You may also consult the Office of Compliance Services or Standard 10 (“Avoiding Conflicts of Interest”) in the UCLA Code of Conduct Handbook at:
http://compliance.uclahealth.org/body.cfm?id=50
Physician’s orders provide directions to the healthcare team regarding medications, treatments, tests, and diets. The order establishes medical necessity for the services provided which in turn supports the payment. All tests/procedures and medications require a physician’s order with the exception of Medicare’s preventive and screening services (seasonal influenza virus vaccine, screening mammogram and pneumococcal vaccine).
A physician’s order needs to be signed, legible, dated and timed.
The ordering provider is a physician or a non-physician practitioner who orders services for a patient in his/her care. Examples of services that might be ordered are diagnostic laboratory tests, clinical laboratory tests, pharmaceutical services, durable medical equipment, and services incident to that physician’s or non-physician practitioner’s service.
It is the ordering provider’s responsibility to order services that are reasonable and necessary according to the patient’s clinical condition or signs and symptoms. Provider’s documentation in the medical record should support the basis of all orders requested.
According to Hospital Conditions of Participation (CoP) from the Centers for Medicare & Medicaid Services (CMS), Standards of the Joint Commission (TJC) and relevant of UCLA Health System policies, orders by physicians and authorized non-physician practitioners must be dated, timed and signed. In addition, their unique UCLA-assigned identification numbers should be recorded.
Citations and references are available from the Office of Compliance Services should there be any questions.
Missing or incomplete signature errors increasingly top the Centers for Medicare and Medicaid - Comprehensive Error Rate Testing (CERT) and Medical Review errors lists. Not only can a missing or incomplete signature delay your claims payment, it can also result in claim denials. Medicare requires that services provided/ordered be authenticated by the author. The method used must be a legible handwritten or an electronic signature. Stamp signatures are not acceptable.
A Physician order is the result of an assessment documented in the physician’s note. The order should be signed, dated and describe the drug, dosage, administration route and rate/frequency for the drug to be given. When the drug is administered the nursing documentation should include the location of the injection/IV site, the vital signs when the infusion begins, the start time, the rate of the infusion, any monitoring interactions and the stop time.
The medical record should reflect a clear picture of the physician’s/NPP’s view as to if it is ‘mild’ versus a ‘severe.’ Descriptive terms such as ‘severe’ will elevate any questions/confusion on the status of the patient’s condition. If the medical reviewer is unable to determine if the patient’s status is ‘severe,’ he/she will determine the condition was ‘mild.’
Reference: Palmetto GBA, Frequently Asked Questions; 2/15/12
Per UC policy, all orders and certain medical record entries must be accompanied by the physician’s identification number (UCLA pager number). One use of this number is to confirm the identity of the signer. The UCLA pager number affixed after the physician signature should only be the number of the person signing the order or medical record entry.
When the Teaching Surgeon is involved in overlapping surgeries where the key portions of the surgery do not overlap, the Teaching Surgeon must be physically present during the key portions of both procedures. All of the key portions of the first procedure must be completed before the Teaching Surgeon can become involved in the second procedure.
If the Teaching Surgeon leaves the operating room to become involved in another case, he/she MUST arrange for another surgeon to be immediately available to intervene in the original case, if necessary. The Teaching Surgeon MUST document his/her participation of the key portions of both procedures.
Did you remember that effective January 1, 2012 the revised Advanced Beneficiary Notice of Noncoverage (ABN) must be used?
The latest version of the ABN, Form CMS-R-131 (has the release date of 3/2011 printed in the left hand corner) must be used by physicians, practitioners, suppliers and independent laboratories in situations where Medicare payment is expected to be denied. All ABNs with March 2008 indicated on them were no longer valid on and after January 1, 2012.
Reference: CMS: https://www.cms.gov/BNI/02_ABN.asp#TopOfPage
A physician query is a question posed to a physician to obtain additional, clarifying documentation to improve the specificity and completeness of the data used to assign diagnosis and procedure codes in the patient's medical record.
Examples of situations where queries are appropriate:
Currently, demand letters from the Recovery Audit Program are sent by Recovery Audit Contractors (RACs) to Patient Business Services (PBS) for hospital billing and to Physician Support Services (PSS) for professional billing at UCLA Health System.
Beginning in January 2012, CMS has shifted the responsibility for sending the demand letters from the RACs to the Medicare Administrative Contractors (MACs). This change may result in demand letters being sent directly to a UCLA Health System healthcare provider, department, division or business unit on the basis of claim information submitted to the MAC. It is essential that such demand letters be forwarded to either PBS or PSS to ensure the appropriate and timely follow-up is done.
To help reduce the numbers of errors related to incorrect use of terminology, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued a list of abbreviations that should NOT be used. The action supports one of JCAHO's national patient safety goals: to improve the effectiveness of communications among caregivers.
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UCLA Health has a policy (HS 9016) on the use of scribes.
Scribe: An individual who is present during the provider’s performance of a clinical service and documents on behalf of the physician the clinically relevant findings as directed by the provider during the course of the service. Scribes are a benefit to physicians however, the physician is ultimately responsible for all documentation.
Limitations
Documentation in the medical record should identify:
Attestation
Each of the scribe and the physician has the responsibility to enter their own respective attestation as described by UCLA’s policy. Please use stated language identified in the policy.
Example of proper scribe statement: “I ________, am scribing for, and in the presence of Dr. ______”. The documentation should include the date and scribe’s full name.
Example of performing provider statement: “I, Dr. ______, personally performed the services described in this documentation, as scribed by ______ in my presence, and it is both accurate and complete.”
Please visit our website for FAQ's on this topic:
http://compliance.uclahealth.org/body.cfm?id=189
We recommend reviewing the UCLA Scribe policy:
http://www.mednet.ucla.edu/Policies/pdf/enterprise/HS9016.pdf
Prolonged services are reported when a physician or non-physician practitioner (NPP) provides direct face-to-face service that exceeds the typical/average time associated with the companion Evaluation & Management (E&M) service in the office/outpatient setting. Documentation must include total time, or start and end times, of the visit, content of the E&M service, and content of the prolonged service.
According to the Centers for Medicare and Medicaid Services (CMS), a split/shared Evaluation and Management (E/M) visit is an encounter with a patient in which both the physician and a qualified Non Physician Practitioner (NPP), i.e. Nurse Practitioner, personally perform a substantive portion of the E/M visit face-to-face with the same patient, on the same date of service. The NPP and the physician must be in the same group practice or employed by the same employer.
The medical record should clearly identify the substantive part(s) of the E/M service that were personally provided by each of the physician and the NPP.
The documentation for split/shared does not require the attestation that is required in Teaching Physician documentation when services involve Resident/Fellow. Moreover, split/shared E/M services are not allowed for critical care services/ procedures.
Advance Care Planning (ACP) CPT codes (99497-99498) are used when providing counseling and/or discussion of advance care directives with the patient, family members, and/or surrogate that may or may not include completion of pertinent legal documents.
The ACP codes would not be reported with Critical Care Critical Care (CPT codes 99291-99292), Neonatal and Pediatric Critical Care (CPT codes 99468-99476) or Initial & Continuing Intensive Care Services (99477-99480). However, codes 99497-99498 can be reported separately in conjunction with other E/M services.
These codes are time based. CPT code 99497 is used to report the first 30 minutes of face-to-face ACP services. CPT code 99468 is for each additional 30 minutes of service.
The UCLA Code of Conduct (The Code) provides guidance on expectations in many areas. One important area addressed in The Code is expectations of practitioners around documentation and billing of services rendered. The Code states that:
Practitioners are expected to document in the medical record information that is true, complete and accurate. Failure to adhere to such expectations may result in corrective actions including and up to termination. Falsifying a medical record for billing purposes could be construed by the Department of Health & Human Services’ Office of the Inspector General as a false claim and can lead to action being taken against the provider by the federal government.
‘Incident-to’ billing is when Non-Physician Practitioners (NPPs) furnish services and the supervising physician bills under his/her own billing number and receives 100% of the physician payment. Correct billing of ‘incident-to’ services in this fashion involves meeting many requirements and it can be complex.
To learn about these requirements, please visit the FAQs posted on the Office of Compliance Services website under FAQs-Professional. http://compliance.uclahealth.org/body.cfm?id=189#faq593
UCLA's Policy on TP Billing (Policy #HS 9100) requires the inclusion of a teaching physician attestation in the progress/procedure note whenever the TP wishes to link to the resident documentation in support of the service billed by the TP.
The Office of Compliance Services has approved several TP attestation templates for use in CareConnect for both Evaluation & Management (E/M) services and procedures/surgeries when residents are involved in the care and treatment of patients and the TP wishes to use the resident's documentation to support the TP's billed service. The TP attestation choices can be found in the smart phrase section of CareConnect. Use ".att" to pull up the appropriate phrases.
According to the Centers for Medicare and Medicaid Services (CMS), a split/shared Evaluation and Management (E/M) visit is an encounter with a patient in which both the physician and a qualified Non Physician Practitioner (NPP), i.e. Nurse Practitioner, personally perform a substantive portion of the E/M visit face-to-face with the same patient, on the same date of service. The NPP and the physician must be in the same group practice or employed by the same employer.
The medical record should clearly identify the substantive part(s) of the E/M service that were personally provided by each of the physician and the NPP.
Split/shared E/M services are not allowed for critical care services/ procedures.
Effective Sept. 10, 2013, the Centers for Medicare & Medicaid Services (CMS) has revised its Evaluation and Management (E/M) Documentation Guidelines (DG), to allow physicians to use the 1997 DG for an 'extended' history of present illness (HPI) with the other elements of the 1995 DG to document an E/M service. As a result, "the status of three or more chronic conditions" qualifies as an Extended HPI for either set of DGs.
According to The Centers for Medicare and Medicaid Services (CMS), 'incident-to' a physician services are services furnished as incidental to, but an integral part of the physician's professional services, in the course of diagnosis or treatment of an injury or illness. Such services are provided by non-physician practitioners/personnel and paid at 100% of the physician fee schedule provided ALL the following requirements are met:
Additional information on 'incident-to' requirements can be found in the Office of Compliance - Physician Services FAQs
There are times at an AMC (Academic Medical Centers) when a surgical procedure is so complex that it requires multiple surgeons. Generally, the expectation is that a resident(s) would be used to assist with the surgery. If no resident(s) are available, the resident(s) available are not sufficiently qualified to provide the needed assistance or the attending physician never uses residents then an attending can assist with the surgery. When billing for such assistant surgeon services, one of the following must be documented in the medical record:
Only time spent by the resident and teaching physician together with the patient or the teaching physician alone with the patient can be counted when reporting critical care services. Time spent by the resident, in the absence of the TP, cannot be billed by the TP as critical care services.
Medical record documentation must support:
When two or more physicians of different specialties provide care that is unique to each of their individual medical specialty and managing at least one of the patient’s critical illness(es) or critical injury(ies) at different times then the initial critical care service (CPT 99291) may be billable by each physician. Additional critical care services provided by another physician within the same specialty can be billed using the add-on code for critical care services (CPT 99292).
The code for the Initial Critical Care Services (99291) may only be reported by one physician in the same group practice if he/she has the same specialty as another physician who also performed critical care services for a patient. The physician billing this code must provide critical care services for at least the minimum amount of time associated with this code in either single session or multiple sessions cumulative throughout the day.
Subsequent critical care visits performed on the same calendar date may represent aggregate time met by a single physician or physicians in the same group practice with the same medical specialty in order to meet the duration of minutes required for CPT code 99292.
A critical care service is time-based. Time counted towards critical care services may be continuous or intermittent and aggregated in time increments on a given day. The total time that critical care services are provided must be documented.
CPT code 99291 is used to report the services of a physician providing full attention to a critically injured patient from 30-74 minutes on a given date.
CPT code 99292 is used to report additional block(s) of time, of up to 30 minutes, each beyond the first 74 minutes of critical care time.
Critical care of less than 30 minutes total duration on a given date should be reported using the appropriate E/M code such as subsequent hospital care.
Current Procedural Terminology (CPT) defines critical care services as physician’s direct delivery of medical care for a critically ill or critically injured patient. It involves decision making of high complexity to assess, manipulate, and support vital organ system failure and/or to prevent further life threatening deterioration of the patient's condition.
A critical illness or injury acutely impairs one or more vital organ systems such that there is a high probability of imminent or life threatening deterioration in the patient’s condition.
When billing venipuncture code 36415 (collection of venous blood by venipuncture), documentation must clearly reflect that it was ordered and performed. Laboratory results alone are not sufficient documentation to bill this service.
Palmetto GBA Medicare guideline states ancillary staff (e.g., RN, LPN, CAN) may only document:
These three areas must be reviewed by the physician or non-physician practitioner (NPP) who must write a statement that it is reviewed and correct or add to it.
Only the physician or NPP that is conducting the E/M service can perform the history of present illness (HPI). This is considered physician work and not relegated to ancillary staff. The exam and medical decision making are also considered physician work and not relegated to ancillary staff.
Reference: Palmetto GBA, Frequently Asked Questions; dated 9/18/12
Palmetto GBA Medicare recommends avoiding the use of the terms ‘noncontributory, unremarkable, or negative’ when reporting, past, family or social history. When these terms are used it does not specify what the nurse or physician asked in terms of specific conditions (i.e., any family history of coronary artery disease).
Reference: Palmetto GBA, Frequently asked questions; dated 10/2/12.
In order for a diagnostic test to be submitted to Medicare/MediCal for payment by the teaching physician, the teaching physician must perform the interpretation of the test results and either:
In order for a diagnostic test to be submitted to Medicare by the teaching physician, the diagnostic test must have been performed by or reviewed with a teaching physician. Medicare does not pay for an interpretation if the teaching physician only countersigns the resident’s interpretation. If the teaching physician’s signature is the only signature on the interpretation, Medicare assumes that he or she is indicating that they personally performed the interpretation. If a resident prepares and signs the interpretation, the teaching physician must indicate that he or she has personally reviewed the image and the resident’s interpretation and either agrees with or edits the findings.
Reference: Palmetto GBA, Frequently Asked Questions; 10/2/12
History Component - Chief Complaint (CC) & History of the Present Illness (HPI)
The medical record must clearly reflect the chief complaint. Do not use the term 'Follow-up or F/U' without expanding upon the reason for the follow-up.
CERT (Comprehensive Error Rate Testing) program data is now being used by the Office of Inspector General (OIG) to identify error-prone providers. The OIG defines an error-prone provider as those who submitted claims with errors such as:
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Coverage of items and services in Category A (Experimental) and B (Non-Experimental Investigational) IDE device studies is determined by the Centers for Medicare & Medicaid Services (“CMS”).
Following receipt of the FDA approval letter, parties seeking coverage determination for Category A or B IDE studies must request coverage approval by submitting a request packet to central CMS .
The local Medicare Administrative Contractor (“MAC”) will only determine/approve coverage for non-significant risk (“NSR”) device studies. The MAC will continue to administer IDE studies approved by the MAC prior to January 1, 2015 (submission to central CMS not required).
For Additional information, please visit our FAQ’s .
Principal Investigators are responsible for submitting sufficient materials and information related to the continuing IRB review of a clinical research study. The applicable information and documentation must be timely submitted (at least one month prior to expiration of approval) to allow the IRB sufficient time to carry out continuing review and issue an approval.If/when an IRB approval expires, all research activities involving human subjects must stop! The only exception to this requirement are activities conducted for study participant safety.
Research activities include, but are not limited to the following:
Retroactive approval for work performed after the expiration date of an IRB approval cannot be granted. Research project activities may resume only after IRB approval has been issued.
By issuing a national coverage determination (NCD), Medicare provides coverage for complex services/procedures rendered as part of a Medicare Approved Registry. The coverage determination stipulates that the medical facility performing the services must meet specific required standards. These standards include ensuring the safety of the beneficiaries receiving services and the provider having the ability and expertise to perform the services/procedures.
Claims submitted to Medicare related to an approved registry must identify the procedures/services by including all of the following:
In all cases, claims submitted to Medicare for services/procedures provided as part of an approved registry must be supported by clinical documentation in the patient’s medical record. The documentation must include information explaining that the services/procedures provided were medically reasonable and necessary in accordance with CMS coverage decision criteria.
For Additional information, please visit our FAQ’s or contact our office directly at 310-794-6763.
When scheduling a patient who is also a clinical research study participant for an evaluation, diagnostic/surgical procedure, or lab test that is unrelated to study participation , the CareConnect encounter should not be associated/linked to the clinical research study in which the patient is designated as “Research: Active.”
For Additional information, please visit our FAQ’s .
The Centers for Medicare & Medicaid Services (“CMS”) covers costs of services rendered to healthy volunteers in a qualified clinical trial under the following conditions:
When billing for routine clinical research study-related services rendered to healthy volunteers, the Z00.6 diagnosis code must be placed in the primary position on the claim, to explain that services were provided to a study participant in the healthy volunteer control group. The other special billing rules (NCT#, condition code 30, Q modifier, revenue code 0624, etc.) are also required, as applicable, depending on the type of claim (hospital/professional/in-patient/out-patient) being submitted.
For Additional information, please visit our FAQ’s .
Every claim submitted to Medicare or a private third party payer must be supported by detailed, accurate, complete and contemporaneous documentation in the patient’s medical record to verify that the services performed were reasonable and necessary, and required the level of service billed.
When billing Medicare for services provided as part of a qualifying clinical trial, the billing provider must include the following clinical research study information in the beneficiary’s (study subject’s) medical record:
While not every study participant will have Medicare coverage, it is best practice to include this information in each subject’s medical record to ensure consistency in documentation of clinical study participation.
For Additional information, please visit our FAQ’s .
Coverage with Evidence Development (“CED”) is a process by which the Centers for Medicare & Medicaid Services (“CMS”) determines coverage and billing of items/services on the condition these are provided in the context of approved clinical studies or additional clinical data collection.
Under CED determination, routine costs of an approved clinical study in both the treatment arm and the control arm are payable by Medicare.
For Additional information, please visit our FAQ’s and the CMS Coverage with Evidence Development webpage.
The Civil Monetary Penalties Law prohibits offering or transferring remuneration to a Medicare or Medicaid beneficiary that may influence the beneficiary to order or receive from a particular provider/practitioner/supplier, any item or service for which payment may be made by Medicare or Medicaid. Violations may result in the imposition of civil monetary penalties (up to $10,000 per item or service) and possible exclusion from participation in Federal or State health care programs.
For additional definitions and information, please visit our FAQ’s.
The False Claims Act (“FCA”) imposes a civil liability on anyone who submits, or causes to be submitted, a claim to the federal government that he/she knows (or should know) is false. Civil penalties (criminal charges may also be brought) for violating the False Claims Act can include fines of $5,500 to $11,000 per false claim plus up to three times the amount of damages sustained by federal payer as a result of the false claim.
Learn More:
MLN, Medicare Fraud and Abuse: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/Fraud_and_Abuse.pdf
The 60-day refund rule, also referred to as the 60-day overpayment rule, is a statutory provision of the Affordable Care Act requiring Medicare and Medicaid providers and suppliers to report and return overpayments within 60 days of identification of the overpayment or, if applicable, the date any corresponding cost report is due.
Myth #1: Medicare will pay for any item/service designated as “Standard of Care” (SOC).
Reality: “Standard of Care” is not a Medicare concept. Payments for clinical study related items/services are issued by Medicare in accordance with coverage rules and defined terms set by statutes, regulations and local Medicare contractors. For more information, please see our FAQs:
http://compliance.uclahealth.org/body.cfm?id=189#faq151
http://compliance.uclahealth.org/body.cfm?id=189#faq156
Myth #2: Unfunded Services on an NIH Grant are billable to Medicare.
Reality: Unfunded patient care costs on a clinical study sponsored by NIH are not necessarily covered by or billable to Medicare. To determine which items/services require study funding and which are billable to Medicare, complete the coverage analysis required under UCLA Policy 915. See Medicare Clinical Trial Policy for detailed information:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&fromdb=true
Myth #3: Clinical research billing compliance laws, rules, and regulations apply only to industry sponsored/funded studies.
Reality: Medicare and Private Payor rules and requirements for documentation, coverage, and billing DO apply to ALL clinical studies. The funding source or lack of a funding source is not relevant. Therefore, it is important to perform itemized coverage analysis to identify which protocol services are billable and, when encountered using CareConnect, to enter timely, complete and accurate study, enrollment and encounter information.
Effective January 1, 2015, Medicare coverage of items and services in Category A and B Investigational Device Exemption ("IDE") studies will be determined by the Centers for Medicare & Medicaid Services ("CMS") upon submission by the study sponsor for central approval. The local Medicare Administrative Contractor ("MAC") will only determine/approve coverage for non-significant risk ("NSR") device studies.
IDE studies approved by the MAC prior to January 1, 2015, will continue to be administered by the MAC and do not require submission to CMS for central approval.
Documentation to support billing protocol items/services to insurance must be present in the patient’s medical record, just as for any other care. Supporting documentation required by the payor would include a complete, accurate, and detailed record of the care, such as:
The following information is required and must be accurately provided on the Research Study Submission Form when requesting study record set-up in CareConnect:
Missing/wrong information will delay set-up and ability to schedule protocol visits in CareConnect.
Research Study Submission Form link: http://careconnect.uclahealth.org/secure.cfm?id=122
Effective January 1, 2014, CMS will require the clinical trial number be reported on all claims for items/services related to qualifying clinical trials (i.e. clinical trials, clinical studies, CMS-approved Category A and B Device trials, or registries resulting from studies covered under Coverage with Evidence Development).
The number to be reported on the claim is the number assigned by the National Library of Medicine ClinicalTrials.gov website when a new study is entered in the NLM Clinical Trials database.
Resources:
All new and legacy clinical studies, including Investigator-Initiated studies, (whether funded or unfunded, and regardless of the funding source) that may include any clinical or research items, tests, procedures, interventions or other services on study subjects performed at any UCLA Health System location, must be submitted to the Clinical Trial Administration Office to complete required Coverage Analysis Process under UCLA Policy 915.
Resources:
UCLA Policy 915: http://www.adminpolicies.ucla.edu/pdf/915.pdf Clinical Trials Administration Office (CTAO): http://clinicaltrials.ucla.edu/
The study coordinator or designated study staff can “link the visit” to the study before the encounter closes by:
In order to do the above, the study must be set-up on CareConnect and the patient must be enrolled in the study on their medical record in CareConnect. If these steps are not completed, charges will likely be billed to the wrong payer. For CareConnect Tip Sheets & Job Aids for Research, visit: http://careconnect.uclahealth.org/secure.cfm?id=341
Federal and state agencies are increasing efforts to reduce fraud, waste, and abuse in healthcare spending. If you are contacted directly by phone or in writing please contact the Office of Compliance Services. The following research-related documents should be readily available for review when research-related claims are audited by a government agency:
A “Qualified Clinical Trial” is a clinical study that meets stated regulatory requirements to be eligible for Medicare coverage of certain study-related patient care costs, called “routine costs”, under the Medicare Clinical Trial Policy. If you are unsure what is a qualifying clinical trial please visit our FAQs:
For more information:
When submitting a request (requisition) for a clinical study-related procedure, be sure to include the following information in the “Reason for Test” section or alternate prominent location on the form:
Study Record - Clinical study information must be ready in CareConnect for Go-Live March 2013. To allow time for questions, each clinical study team should submit as soon as possible using the Research Study Submission Form available here: http://careconnect.uclahealth.org/secure.cfm?id=122
Training - Please enroll in the following classes if you will conduct or coordinate clinical studies within the UCLA Health System inpatient and/or outpatient setting.
http://careconnect.uclahealth.org/Workfiles/secure/Training/Catalog_082112.pdf
There are special rules for individuals enrolled in a Medicare Advantage Organization (“MAO”) who may also participate in a clinical study that is a qualifying clinical trial. These rules are even more complex than those for individuals who participate in Medicare fee-for-service.
Be sure you understand the specific coverage allowance and billing requirements of a subject’s insurer before billing any clinical study related services to a Medicare Advantage Plan.
For additional information about clinical trial billing to MAOs, please see:
http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R107MCM.pdf(Section 10.8- Clinical Trials)
The following documents should be referenced when preparing a coverage analysis for a Clinical Study:
The Principal Investigator should maintain copies of all such reference documents and citations with the study financial records.
The primary documents that indicate the financial terms of a Clinical Study are:
Before proceeding with a Clinical Study, ensure that these documents all state exactly the same plan so the institution, investigator, study team, billing offices, and study participant have consistent information regarding who will pay for study-related items and services.
Effective July 15, 2012 per new UCLA Policy 915, a Coverage Analysis is required for all new industry-sponsored, industry-authored, federally funded or non-profit supported (NIH, CMS, foundation grants), and investigator-authored clinical trials and clinical research studies conducted within the UCLA Health System and the DGSOM.
For questions regarding the coverage analysis process, or to access the new Clinical Trial Budget and Coverage Analysis documents, please access the faculty/staff section of the Clinical Trials Administration Office (CTAO) website at: http://clinicaltrials.ucla.edu. If you need a user name and password for the website, please contact the CTAO office at: clinicaltrials@mednet.ucla.edu.
For additional clinical trial billing information, please visit the Office of Compliance Services website at: http://compliance.uclahealth.org/body.cfm?id=73.
Proper Claims for Clinical TrialsAvoid submitting improper claims related to clinical research by:
Some pitfalls to avoid when billing for services and managing funds in a clinical trial:
Billing for services provided as part of a qualifying clinical trial requires compliance with the following medical record documentation requirements:
The billing provider must include the following clinical trial information in the beneficiary's medical record:
While not every participant will have Medicare coverage, it is best practice to include this information in each subject's medical record since the research team may not know what type of insurance the subject has or may have in the future.
Medicare Claims Processing Manual, Chapter 32, Section 69.3
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c32.pdf
Tips to avoid clinical research billing errors for services related to Qualified Clinical Trials:
