Advanced Beneficiary Notice (ABN)
An Advanced Beneficiary Notice (ABN) should be obtained anytime the provider is aware that services to be furnished to a patient will not be covered. Determination of when this applies is guided by National Coverage Decisions (NCD) published by CMS. Copies of the NCD are provided to health care providers utilizing Regional West Laboratory Services (RWLS). An ABN is not required, but is desirable if the service is defined by Medicare as non-covered.

Obtaining an ABN:

1. An ABN may be obtained when a provider (clinician, laboratory staff, nurse, etc.) is aware that the services to be furnished to a patient will not be covered or when there is genuine doubt.
2. To be valid, a patient or patient representative must be notified in writing at the time of, or prior to performance of the service. The clinician or a member of the clinician's staff should do this. However, if the laboratory does not receive written notice that the clinician or his/her designee has provided this notification to the patient or patient representative, RWLS staff will perform this notification. This, of course, applies only to those patients who present to the laboratory at Regional West Medical Center for specimen collection.
3. Providers are not required to submit claims for non-covered services, but the patient can request that the provider submit a claim for reimbursement. RWLS will submit claims for potential non-covered services, but will maintain the signed ABN so that if payment is denied, the beneficiary can be billed for the service. If a non-covered service is denied, Regional West Medical Center (RWMC) will bill the beneficiary for the service even if an ABN has not been obtained.
4. An ABN should only be obtained when there is a reasonable basis for the belief that a service is non-covered, i.e. the NCD indicates that the diagnosis provided does not document medical necessity or the test is ordered as a screening procedure (e.g., Pap smear). It is not acceptable to use a blanket ABN for each patient to cover the possibility that a service may be regarded as non-covered. Therefore, every patient who receives any laboratory service cannot be asked to sign an ABN for any and all services. The exceptions to this rule are any screening tests that have frequency limitations defined by the Centers for Medicare & Medicaid Services (CMS). This includes:
   • Screening Pap Smear - covered once every two years
   • Screening PSA - covered once every 12 months for male Medicare beneficiaries over the age of 50
   • Screening Occult Blood - 1-3 determinations every 12 months for Medicare beneficiaries over the age of 50
   • Diabetes Screening Tests - Fasting Glucose, Post-Glucose Challenge Test for Medicare beneficiaries that meet eligibility requirements
   • Cardiovascular Disease Screening - Cholesterol, HDL, Triglycerides for Medicare beneficiaries that meet eligibility requirements
5. The ABN must document the patient's name as it appears on the Medicare/Medicaid card.
6. The basis for believing that a service may not be covered (reason for denial) must be documented by the laboratory or other party obtaining the ABN.
7. The ABN must be obtained prior to providing the service. This means that an ABN may be acceptable with a date after the specimen is collected, but prior to the test being performed.
8. The ABN must designate the service that the provider believes will not be covered.
9. The ABN must be signed by the patient or patient representative and must be dated to show that the ABN was obtained prior to performing the service.
10. A representative of the nursing home or beneficiary representative who signs on other matters may sign an ABN for a laboratory service for a mentally incompetent patient in a nursing home. The following individuals are permitted to sign for the beneficiary (42 CFR δ 424.36):
    • Legal Guardian
    • Relative or other person who receives Social Security or other benefits on behalf of the beneficiary
    • Relative or other person who arranges treatments for the beneficiary
    • Representative of the nursing home
    • Representative of the provider, if the provider cannot have someone who meets the above requirements sign the claim
11. Standing Orders - An ABN is required at the outset of the treatment for a non-covered service and is effective as long as no new services not specified in the standing order are provided. If new services are provided, then a new ABN is necessary.
12. Patient Refusal - A beneficiary has the choice to either refuse or obtain the service. He/She does not have the choice to obtain the service, but refuse to sign an ABN and be responsible for payment if the service is non-covered. If the beneficiary demands that a service be performed, but refuses to sign the ABN, a second person should witness the refusal and document this and his/her signature on the ABN statement. A note to the patient file should indicate the two persons present who witnessed the patient refusal. If only one person is present in the physical location with the patient, the second witness may be contacted by telephone to witness the refusal and then sign the ABN later. If the beneficiary refuses the service, the physician should be notified. This should be documented on the requisition.
13. Nursing homes may elect to perform testing on a resident based on state laws or quality of care practices as defined by the nursing home. In this case, medical necessity requirements may not be met and the nursing home may elect to have the services billed back to the nursing home rather than to the resident. In this case, the laboratory will bill the services as non-covered and bill the nursing home.

Format of an Advanced Beneficiary Form - Medicare has published acceptable formats for the ABN. The standard formats may not be modified except for the customizable boxes provided for listing the laboratory tests. Any change to the area of the ABN which is not customizable will result in a defective ABN. Contact Client Services at 888-522-7962, 308-630-1398, or clientservices@rwhs.org for a copy of an ABN form, showing all sections highlighted in yellow that must be completed.

Animal Specimens 
We do accept animal specimens for limited laboratory testing.

Acceptable Volumes
Minimum acceptable volumes are listed in this directory, for each test. If there is insufficient volume for testing, we will attempt to locate any additional sample within the laboratory, which was collected at the same time. If none are found, you will be contacted for recollection.

Billing
Client - Each month you will receive an itemized invoice/statement which will indicate the date of service, patient name, CPT code, test name, and test charge. Payment terms are net 30 days. When making payment, please include our invoice number on your check to ensure proper credit to your account.

Patient - To allow Regional West Laboratory Services (RWLS) to bill patient's insurance, please include the following required billing information: responsible party, patient's name, current address, zip code, phone number, Social Security number, date of birth, gender, and diagnosis code, along with policy holder name, address, phone number, date of birth, and gender. Providing this information will avoid additional correspondence to your office at some later date. Please advise your patients that they will receive a bill for laboratory services from RWLS for any personal responsibility after insurance payment. VISA® and MasterCard® are acceptable forms of payment.

Billing Change Requests
Regional West Medical Center (RWMC) bills charges to clients, insurance companies, Federal programs (e.g., Medicaid, Medicare) or patients. Due to Federal regulation, the laboratory that performs the testing on a Medicare or Medicaid patient must bill that program for the testing. The exception is when a hospital refers a test to another laboratory in which case the referring hospital is still required to bill for testing done on its registered inpatient regardless of who did the testing. The laboratory bills, based on the information provided on the requisition by the requesting physician.

Any requests for billing changes should be provided in writing by the requesting physician representative. See Special Instructions for a copy of the Billing Change Request form. All appropriate information must be provided to allow RWMC to bill the charges. Requests must be received within 60 days of the date of service, and RWMC cannot accept requests for partial billing changes. All tests ordered on a single requisition, must be changed.

Blood Bank Specimens
The American Association of Blood Banks, in its Standards for Blood Banks and Transfusion Services (21st edition, 2002), requires that blood samples to be used in preparation of blood for transfusion: "be labeled in the presence of the intended recipient, that the sample label contain two independent patient identifiers plus collection date, and that there be a mechanism to identify the individual who drew the blood." Samples sent to Regional West Laboratory for transfusion-associated tests, need to meet these requirements.

In an emergency situation where no patient information is available, the green SecurlineTM blood bank armband number will be used for identification until patient information and history are available. If a trauma number is available, this number should be recorded on the specimen tube, also.

Cancellation of Tests
Cancellations received prior to test setup will be honored at no charge. Requests received following test setup cannot be honored. A report will be issued automatically and charged appropriately.

Competitor Disclaimer 
As to tests that are identified as being performed by parties other than Mayo Medical Laboratories (MML) or Regional West Laboratory Services (RWLS), the information regarding such tests was obtained from the test provider's most recent available test catalog, as supplemented by any additional information provided to MML or RWLS by the test provider. Neither MML nor RWLS warrants or endorses the timeliness or accuracy of any such information. If you have any concerns or questions about the timeliness or accuracy of such information, you should contact RWLS Client Services at 888-522-7962 or 308-630-1398.

CPT Coding 
It is your responsibility to determine correct CPT codes to use for billing. While this directory lists CPT codes in an effort to provide some guidance, the CPT codes listed reflect only our interpretation of CPT coding requirements and are not necessarily correct. Particularly, in the case of a test involving several component tests, this directory attempts to provide a comprehensive list of the CPT codes for all of the possible components of the test. Only a subset of component tests may be performed on your specimen. You should verify accuracy of codes listed; and where multiple codes are listed, you should select codes for tests actually performed on your specimen. REGIONAL WEST LABORATORY SERVICES (RWLS) ASSUMES NO RESPONSIBILITY FOR BILLING ERRORS DUE TO RELIANCE ON CPT CODES LISTED IN THIS DIRECTORY. For further reference, please consult the CPT Coding Manual published by the American Medical Association; and if you have any questions regarding the use of a code, please contact your local Medicare carrier.

Critical Values 
The "Notification of Critical Results" policy of Regional West Laboratory Services (RWLS) is described below. 

Definition of Critical Value - A critical value is defined by RWLS as a value that represents a pathophysiological state at such variance with normal (expected values) as to be life-threatening.

Abnormals are Not Considered Critical Values - Most laboratory tests have established reference ranges, which represent results that are typically seen in a group of healthy individuals. While results outside these reference ranges may be considered abnormal, abnormal results and critical values are not synonymous. Analytes on the RWLS Critical Values List represent a subgroup of tests that meet the above definition.

Action Taken when a Result is Obtained that Exceeds the Limit Defined by the RWLS Critical Values List - All critical results will be called to the appropriate nursing personnel responsible for the primary care of the patient or directly to the physician. Notification for in-house testing will be made within 30 minutes of test completion and within 60 minutes for testing sent to a referral lab. In the event that contact is not made within the 60-minute period, we continue to call, and will fax the results if telephone contact is deemed impossible.

The exceptions to this rule are those providers who have notified RWLS that they do not want critical values called to them outside their office hours. In these cases, the critical results will be called when the office opens next.

Disclosures of Results - MML
Under federal regulation, we are only authorized to release results to ordering physicians or other health-care providers responsible for the individual patient's care. Third parties requesting results, including requests directly from the patient, are directed to the ordering facility.

Disclosures of Results - RWLS 
Referral Specimens - Third party requests for laboratory results on specimens sent to RWLS by other laboratories or physician offices will be referred back to the ordering entity. 
Outpatient Requests - RWLS prefers the patient obtain lab results from the physician. However, results will be released directly to the patient under the following guidelines:

• There are certain tests that require interpretation by the physician and cannot be released to the patient. These are:
  • Chlamydia / GC Testing
  • Cultures
  • Cytopathology Results
  • Drug Testing
  • Genetic Testing (e.g., Cystic Fibrosis, Quad Screen)
  • Hepatitis Testing
  • HIV
  • Pregnancy Testing
  • Surgical Pathology

  In these cases, the patient will be referred to the ordering physician.

• Verbal Results - The patient may call the laboratory for verbal results if he/she completes and signs an "Authorization for Use & Disclosure of Protected Health Information" form and establishes a password at the time of collection.
• Fax Results - Results will be faxed to a health care provider only if the fax number can be verified. Results cannot be faxed to a personal fax number.
• Mail Results - RWLS does not mail lab reports. The patient will be referred to either the Health Information Management Department or to their physician. Health Fair testing results may be obtained from either the draw site or the patient's physician.

Provider Requests - Results will be given on request, to any provider(s) involved with a patient's treatment or care.

HIPAA Compliance 
Regional West Laboratory Services is fully committed to compliance with all privacy, security, and electronic transaction code requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). All services provided by Regional West Laboratory Services that involve joint efforts will be done in a manner which enables our clients to be HIPAA and the College of American Pathologists (CAP) compliant.

Infectious Material
The Centers for Disease Control (CDC) in its regulations of July 21, 1980, has listed organisms/diseases for which special packaging and labeling must be applied. Required special containers and packaging instructions can be obtained from us by using the "Request for Supplies" form located in Special Instructions.

Shipping regulations require that infectious substances affecting humans be shipped in a special manner. Call Client Services at 888-522-7962 or 308-630-1398 for specific instructions. A copy of the regulations can be requested from the International Air Transport Association (IATA); they may be contacted by phone at 514-390-6770 or faxed at 514-874-2660.

Informed Consent
Submission of an order for any tests contained in this catalog constitutes certification to Regional West Laboratory Services (RWLS) and Mayo Medical Laboratories (MML) by ordering physician that: (1) ordering physician has obtained Informed Consent of subject patient as required by any applicable state or federal laws with respect to each test ordered; and (2) ordering physician has obtained from subject patient authorization permitting RWLS and MML to report results of each test ordered directly to ordering physician.

On occasion, MML will forward a specimen to an outside reference laboratory. The laws of the state where the reference laboratory is located may require written informed consent for certain tests. RWLS and MML will request that ordering physician pursue and provide such consent. Test results may be delayed or denied if consent is not provided. Any costs incurred will remain the obligation of ordering party.

Medicare Coverage of Laboratory Testing
When ordering laboratory tests that are billed to Medicare/Medicaid or other federally-funded programs, the following requirements may apply:

1. Only tests that are medically necessary for the diagnosis or treatment of the patient should be ordered. Medicare does not pay for screening tests, except for certain specifically approved procedures and may not pay for non-FDA-approved tests or those tests considered experimental.
2. If there is reason to believe that Medicare will not pay for a test, the patient should be informed. The patient should sign an Advance Beneficiary Notice (ABN) to indicate that he or she is responsible for the cost of the test if Medicare denies payment. See "Advanced Beneficiary Notice (ABN)" on page 3.
3. Organ- or disease-oriented panels should be billed to Medicare only when every component of the panel is medically necessary.
4. RWLS- and client-customized panels should be billed to Medicare only when every component of the customized panel is medically necessary.
5. Medicare National Limitation Amounts for CPT codes are available through CMS or its contractors. Medicaid reimbursement will be equal to or less than the amount of Medicare reimbursement.

Ordering Laboratory Tests
Requests for laboratory testing must be initiated by a licensed physician or other authorized provider. Acceptable formats for orders include:

1. Written order on a physician prescription pad
2. Completed requisition form - All specimens received in the lab from outside sources must be accompanied by a valid request form or completed requisition. The requisition should include:
   • Patient's full name or an ID number assigned by a clinic or physician. Requests for confidential testing (e.g., HIV, drug testing) are accepted. The ordering physician should provide a number to be used in place of the name. For these orders, date of birth, age, and sex are not required.
   • Physician (or other qualified provider)
   • Gender
   • Date of Birth
   • All billing information as requested and/or required to bill. When a requisition is received with incomplete information, the ordering physician will be contacted for additional information. The completeness of information required depends on who will be billed and the test(s) ordered.
   • Name of test(s) requested
   • Appropriate collection information: date, time, and initials of phlebotomist
   • Source of specimen when appropriate
   • Appropriate clinical data (e.g., diagnosis, history on Pap smears)
3. Verbal request