50 Essential Forms for Laboratory Compliance

Transcription

1 Essential Forms for Laboratory Compliance With contributing editor Kelly A. Briganti, JD Achieve and demonstrate lab compliance with this book and CD-ROM set! Additional HCPro titles for your laboratory compliance library: OSHA Guidebook for Labs book Complete Guide to Laboratory Safety book Laboratory Compliance Insider newsletter About HCPro HCPro, Inc., is the premier publisher of information and training resources for the healthcare community. We produce newsletters, books, audioconferences, training handbooks, videos, online learning courses, and professional consulting seminars to meet the needs of specialists in health information management, compliance and accreditation, quality and patient safety, nursing, pharmaceuticals, medical staff, credentialing, long-term care, physician practice, infection control, safety, and laboratories. Visit the Healthcare Marketplace at for more FEFLC HCPro P.O. Box 1168 Marblehead, MA Essential Forms for Laboratory Compliance

2 Contents About the contributing editor iv Introduction v Using the files on your 50 Essential Forms for Laboratory Compliance CD-ROM viii Chapter 1: Billing and reimbursement Chapter 2: General compliance Chapter 3: Reporting compliance Chapter 4: Privacy and security Chapter 5: Safety Chapter 6: Training and continuing education Chapter 7: Dealing with ordering physicians Chapter 8: Other laboratory issues

3 C h a p t e r o n e Billing and reimbursement

4 C h a p t e r o n e 50 FORMS In the wake of CMS clarifying date-of-service issues, labs should set or update written policies for dates of service for routine specimens, archived specimens, and specimens collected over time. The clarifications involve archived specimens and specimens collected over a period of more than 24 hours. Use the following sample policy to help you outline CMS decision about date-ofservice issues. The sample policy explains that Medicare billing rules require you to supply a date of service and that this policy will define that date states that the date of service is generally the date of collection defines archived specimens as set forth by CMS and states that for such specimens, you should record the date of service as the date you obtained the specimen from archives indicates that for tests involving specimens collected over a period of time exceeding 24 hours, the date of service is the date on which such collection ended Lab consultant Diana W. Voorhees, MA, CLS, MT, SH, CLCP, principal at DV & Associates in Salt Lake City, helped create this policy. Show this sample policy to your attorney before using it in your lab. 1

5 Billing and reimbursement FORM 1 Set an updated statement on dates of service Use this sample policy to discuss the date of service for tests performed on archived specimens and specimens collected over time. It reflects actions CMS has taken to finalize these dates of service. Show this sample to your attorney before using it in your lab. Policy on dates of service Purpose: Every claim for clinical laboratory services rendered to Medicare beneficiaries must include a date of service. In February 2005, CMS issued a final rule clarifying the dates of service for tests performed on archived specimens and specimens collected over a period of time exceeding 24 hours. Our laboratory has adopted the following policy regarding the appropriate dates of service based on CMS clarification: 1. Routine specimens. The date of service for lab services is the date the lab collected the relevant specimen from the patient, unless an exception applies. 2. Archived specimens. The date of service for tests performed on archived specimens is the date the lab obtained the specimen from archives. CMS has defined archived specimens as those stored for more than 30 days. Therefore, when billing for services performed on a specimen stored for 31 days or more, list the date on which the lab collected the specimen from archives as the date of service for all Medicare claims. If the lab stores the specimen for 30 days or less, use the date on which the lab collected the specimen from the patient as the date of service. 3. Specimen collection spanning more than 24 hours. For tests in which the specimen collection spanned 24 hours or more, use the date that the specimen collection ended as the date

6 C h a p t e r o n e 50 FORMS You need the cooperation of skilled nursing facilities (SNF) to provide accurate information regarding the Medicare coverage status of any of their residents who receive lab services from you. According to a December 2004 CMS transmittal, SNFs must furnish accurate information concerning residents Medicare status to outside providers. Use the following sample letter to remind SNF clients to send information you need to bill properly for lab services rendered to their residents. The letter to SNFs should mention the CMS transmittal refer to your written agreement and the provisions requiring the SNF to supply billing information remind the SNF that both you and it face liability if either side submits claims in violation of the consolidated billing rules tell the SNF to supply the billing information required and that the requisition has a place for this information mention that your agreement with the SNF requires it to provide reports detailing its patients Medicare status Lab consultant Christopher P. Young, president of Laboratory Management Support Services in Phoenix, and Ronald L. Wisor of Arent Fox PLLC in Washington, DC, helped develop this letter. 2

7 Billing and reimbursement FORM 2 Remind SNFs to provide necessary billing info Here s a letter you can adapt and use to remind your skilled nursing facility (SNF) clients to send information you need to bill properly for lab services rendered to their residents. Show this letter to your attorney before you send it. Dear SNF client, As you know, our laboratory provides services to some of your residents pursuant to a written agreement. CMS emphasized in a December 2004 transmittal that SNFs must furnish accurate information concerning a resident s Medicare status to outside providers. Section [insert relevant section of your agreement] of our agreement requires you to give us the information we need to determine when we may bill Medicare for lab services and when we must instead seek reimbursement from you. If you do not provide this information, both your facility and our laboratory risk violating the False Claims Act. If our lab doesn t know the Medicare status of the resident and improperly bills services that Medicare covers under Part A, the government may view us as submitting a false claim and your SNF as causing us to submit that false claim. The government can also charge you with violating your Medicare provider agreement, which requires you to comply with consolidated billing requirements. To avoid any problems, it s important to promptly provide accurate information regarding the Medicare coverage status of any of your residents who receive lab services from us. You can provide this information on our requisition form. Also, please remember that our agreement requires you to provide reports regarding your residents Medicare status every [insert frequency]. We appreciate your cooperation in this matter. If you have any questions or concerns regarding this issue, please contact our lab.

8 C h a p t e r o n e 50 FORMS When renewing your annual agreements with physicians for custom reflex testing, use this sample cover letter to encourage referring physicians to renew. Reflex testing is important because labs routinely perform these tests as follow-ups to initial test results when those results indicate the need for more diagnostic information. The cover letter should explain that the physician needs to review and confirm the terms of the agreement. Consider including in the letter a list of revised sections of the agreement and the reasons for those changes. Include two copies of the letter: one for the physician to sign and return, and another for the physician s records. Lab consultant Christopher P. Young, president of Laboratory Management Support Services in Phoenix, developed this letter. Show this letter to your attorney before using it. 3

9 Billing and reimbursement FORM 3 Ask physicians to review and renew feflex testing agreements Dear referring physician, Attached please find the agreement that states our lab should perform the custom reflex tests you have requested and the circumstances under which those activities will occur. You must renew this agreement annually. Therefore, please review the agreement, the listed custom reflex tests, and the described triggering circumstances to ensure that they are appropriate. [Optional] Please pay particular attention to the following revisions that our lab has made to the attached agreement: [Insert the list of revised sections and explain the reason for the revisions]. If you wish to make any changes to the agreement, indicate the alteration on the agreement. Please remember that you can order the initial test without the reflex option [insert explanation of how to do so e.g., by ordering just the initial test without indicating with reflex on the requisition]. Our lab will perform reflex tests only when you specifically indicate in your test requisition that you desire the reflex test. Please remember to supply appropriate ICD-9 codes with test requisitions to support the medical necessity of all tests ordered, including reflex tests, as required by Medicare regulations. If you wish to renew this reflex-testing agreement, please sign the bottom of this letter and return it and the reflextesting agreement to our lab within 10 business days. We ve sent a courtesy copy of this letter and the agreement, which you may keep for your records. If we do not receive a response by [insert date], we will assume that you do not wish to renew the reflex-testing agreement, and it will expire effective [insert date]. Thank you. I acknowledge that I have reviewed the attached reflex-testing agreement, and that I wish to continue this agreement. Signature: Date:

10 C h a p t e r o n e 50 FORMS A referring physician sometimes orders a service for a patient that Medicare won t cover. A signed advance beneficiary notice (ABN) allows you to bill the patient for such a service. To make sure that everyone in your lab knows how and when to use ABNs and notices of exclusion, provide staff with the following explanatory memorandum. The memo should explain what an ABN says emphasize that a patient must receive and sign an ABN before the lab performs a test caution that staff should only distribute ABNs on a case-by-case basis and not routinely point out that staff must use a notice of exclusion when Medicare never covers a test that a physician recommends explain that using a notice of exclusion isn t mandatory, but that it may be helpful to staff and patients Attaching copies of ABNs and notices of exclusion to your memo helps staff grasp the difference between the two forms. 4

11 Billing and reimbursement FORM 4 Explaining ABNs and notices of exclusion To: Lab staff Re: Proper use of ABNs and notices of exclusion Medicare rules require us to obtain an advance beneficiary notice (ABN) when Medicare may not cover a test or service. In many cases, the referring physician will have the patient sign the ABN. But when our lab gives a patient an ABN, it is crucial that we abide by Medicare rules and use ABNs appropriately. It is important that we inform our patients of their financial responsibilities regarding the services they receive. Accordingly, all lab staff members are responsible for knowing and observing the following practices: 1. An ABN informs the patient that his or her Medicare benefits may not cover a service or test that a physician orders because Medicare may not consider the service medically necessary. The ABN explains that the patient may refuse the recommended service and that if the patient opts to receive the service, he or she is responsible for payment. 2. The lab must give an ABN to the patient to sign before the patient receives the recommended service. 3. Distribute ABNs only on a case-by-case basis, not routinely. Provide an ABN only if there is a specific, identifiable reason to believe Medicare might not pay for the test. 4. If Medicare never covers the test or service the physician orders, the patient should not receive an ABN, but rather a notice of exclusion from Medicare benefits. The notice of exclusion explains that Medicare does not cover the service. 5. Use of a notice of exclusion is not mandatory, but we recommend it. We have attached a copy of each form to the memo for your review.

12 C h a p t e r o n e 50 FORMS To help staff properly document additional diagnostic information obtained over the phone and to protect your lab from compliance problems, use this model policy. The policy explains to staff why proper documentation is essential and shows how to document the information. It also warns them to steer physicians to supply specific codes and advises them that they ll be monitored to ensure compliance. The policy gives you a choice of two methods of documentation having staff simply write the information on the requisition or having them fill out a special form. Ronald L. Wisor of Arent Fox PLLC, and Hope S. Foster of Mintz Levin Cohn Ferris Glovsky and Popeo, both in Washington, DC, helped create this policy. Show this policy to your attorney before adapting it for use in your lab. 5 10

13 Billing and reimbursement FORM 5 Requesting additional diagnostic information from referring physicians 1. Purpose of Policy All test requisitions must have appropriate diagnostic codes or narrative information so that XYZ Laboratory can submit complete and accurate claims for lab services. When requisitions lack sufficient diagnostic codes or narrative information, XYZ Laboratory must contact the referring physician by phone to request the necessary additional diagnostic information to support the medical necessity of the test order. XYZ Laboratory has established this policy to ensure that staff requesting this additional diagnostic information do so consistently and in a manner that does not violate XYZ Laboratory s compliance program. Even inadvertent errors can affect claims submissions and reimbursement. Therefore, all staff requesting additional diagnostic information from referring physicians must follow this policy. 2. How to Document Information Option a Each time you get additional diagnostic information from a referring physician or the physician s office staff, note that information on the relevant requisition. Always include the following key facts: Name and title of person at physician office with whom you spoke Information supplied (i.e., diagnostic code or narrative information) Date and time of the contact Your initials or signature Option b XYZ Laboratory has created a standard form for recording additional diagnostic information supplied by referring physicians. A copy of that form is attached to this policy. Use the form to document every request to a referring physician for additional diagnostic information. Attach 11

14 C h a p t e r o n e FORM 5 Requesting additional diagnostic information from referring physicians (cont.) the completed form to the relevant test requisition. Do not omit any of the information the form requests. 3. Don t Steer Physicians to Specific Codes When requesting additional diagnostic codes or narrative information to support a test requisition, do not suggest specific diagnosis codes to the physician or his staff or in any way encourage physicians to choose specific diagnosis codes. 4. Policy Is Subject to Compliance Audits All staff must comply with this policy. XYZ Laboratory will monitor compliance with this policy and will audit records documenting additional information received from referring physicians. Any violations of this policy will be subject to disciplinary action as set forth in XYZ Laboratory s Compliance Plan. [Insert information about where staff can get a copy of the compliance plan.] 12

15 Billing and reimbursement 50 FORMS When a staff member contacts a physician office to collect missing diagnostic information, it s critical that he or she properly document the information that supports the medical necessity of the services your lab performs. Give the following model form to staff who contact physicians to collect additional diagnostic information from physicians. A staff member should fill out the form each time such information is needed and attach the form to the related test requisition. Note that the form asks for the patient s name/test requisition number, but your lab may only want one of those pieces of information or other identifying information. Ronald L. Wisor of Arent Fox PLLC and Hope S. Foster of Mintz Levin Cohn Ferris Glovsky and Popeo, both in Washington, DC, helped develop this form. 6 13

16 6 C h a p t e r o n e FORM 6 Additional diagnostic information from referring physicians Use this form to document efforts to collect missing diagnostic information from referring physicians. Attach this form to the relevant test requisition. 1. Patient name/test requisition number 2. Name and telephone number of referring physician 3. Name and title of individual at physician office supplying the information 4. Date and time physician office contacted and information supplied (Note each attempt to contact office, including when the information was ultimately provided) 5. Description of information supplied: Test ordered Diagnostic code or narrative 6. XYZ Laboratory staff member collecting information: Print name: Signature: 14

17 Billing and reimbursement 50 FORMS Use the following model questionnaire to help your hospital lab get accurate Medicare Secondary Payor (MSP) information from Medicare outreach patients any time your staff has face-to-face encounters with those patients. Because you are the party submitting a claim for lab tests, CMS holds you responsible for the accuracy of the information in the claim, including MSP information. The questionnaire asks Medicare patients about the availability of other healthcare benefits (e.g., employer group health plans, other federal program benefits, and liability insurance covering personal injury) that may be primary to Medicare. The questionnaire is based on one used by the Pathology and Laboratory Medicine Department at St. Peter s Hospital in Albany, NY, and on sample questions provided in CMS s Medicare Secondary Payor Manual, Chapter 3. Show it to your attorney before adapting and using it in your lab. 7 15

18 C h a p t e r o n e FORM 7 Medicare secondary payor questionnaire 1. Do you have any group health plan coverage based on your current employment? q Yes q No 2. If so, approximately how many employees work for the employer? 3. Do you have group health plan coverage based on a spouse s or family member s current employment? q Yes q No 4. If so, how many employees work for the company? 5. If you/your spouse is retired, please provide the date(s) [day/month/year] of retirement: Patient Spouse 6. Are you receiving federal black lung benefits? q Yes q No 7. Are you receiving benefits from any other federal government program, such as a research grant or Veterans Affairs? q Yes q No 8. Are you receiving workers compensation benefits? q Yes q No 9. Are you receiving treatment for an illness or injury covered under your or another party s automobile no-fault insurance? q Yes q No 10. Are you receiving treatment for an illness or injury for which payment may be made for your healthcare benefits from your or another party s liability insurance, such as homeowners, fire, or other general liability insurance? q Yes q No 11. Are you under age 65, receiving Medicare benefits for disability, and covered by a group 16

19 Billing and reimbursement FORM 7 Medicare secondary payor questionnaire (cont.) health plan provided through your current employer or the current employer of any family member? q Yes q No 12. If so, approximately how many employees work for the employer? 13.Are you currently receiving Medicare benefits for treatment of end-stage renal disease? q Yes q No Have you received a kidney transplant? q Yes If yes, provide date q No Have you received maintenance dialysis treatments? q Yes If yes, provide date started q No Did you participate in self-dialysis training? q Yes If yes, provide date started q No 17

20 C h a p t e r o n e 50 FORMS Use the following memorandum to take advantage of the CMS rule that provides steps for labs to follow when a patient refuses to sign an ABN, but insists on having the test performed anyway. The rule provides labs with steps they can follow that let them bill such a patient if Medicare refuses to pay for a test. A major element is to make your phlebotomists aware of the steps. Lab consultant Christopher P. Young, president of Laboratory Management Support Services in Phoenix, helped prepare the memo. Use the memo as a starting point to draft your own memo and show it to your attorney before using it in your lab. 8 18

21 Billing and reimbursement FORM 18 Set an updated Document statement patients on dates refusal of to service sign ABN To: From: Date: All phlebotomists Compliance officer [Insert date] Instructions: CMS advance beneficiary notice (ABN) rules set steps that labs can follow when a patient refuses to sign an ABN but insists on having the test performed. If you follow these steps exactly, we will be able to receive revenue that would otherwise have been lost the financial obligation to pay for the test falls on the patient. To ensure that all claims are handled consistently, you are required to take the following steps whenever a patient refuses to sign an ABN but insists that the test be performed: 1. Explain that the patient will be billed if he or she insists on having test performed. First, explain to the patient that we are not legally required to perform the test if he or she refuses to sign the ABN. Also tell the patient that if he or she insists that we conduct the test, he or she assumes personal financial responsibility for it should Medicare refuse to pay for it. Tell the patient that it s his or her responsibility to pay for the test even if he or she doesn t sign the ABN. 2. Ask the patient to reconsider his or her decision. If the patient insists on having the test performed, offer him or her one last opportunity to sign the ABN. If the patient refuses or becomes combative, end the discussion as gracefully as possible and follow the steps below. 3. Get another lab employee to witness the patient s refusal to sign. CMS ABN instructions require two people to witness that the ABN has been presented to the patient and that he or she has refused to sign it. Sign the ABN as one witness. Then try to get your supervisor to serve as a second witness. If your supervisor isn t available or you 19

22 C h a p t e r o n e FORM 8 Document patients refusal to sign ABN (cont.) work in an area of the lab where there are other lab employees, ask one of them to serve as a witness and to sign the ABN. 4. Telephone main lab office or other department for a witness, if necessary. If you work in a lab area in which no other lab employees are present, such as a physician s office or a draw station, the ABN rules allow a second party to witness the refusal by telephone. First call your supervisor at the lab and ask him or her to serve as a witness. If you are unable to reach your supervisor, call the following departments (in the following order) and ask a member of that department to serve as a witness: q Laboratory department [insert telephone number] q Patient services department [insert telephone number] q Compliance office [insert telephone number] q Legal department [insert telephone number] 5. Write attestation of patient s refusal to sign on ABN. After you and the witness have presented the ABN to the patient and the patient has been notified of his or her personal financial responsibility for the test and has refused to sign the ABN, [choose one: write or stamp] the following attestation on the face of the ABN: This patient has been notified that Medicare may not pay for this test, has been presented with this ABN, and informed that he or she will become personally responsible for the lab s charges for the test if the lab performs the test and Medicare denies payment. The patient has refused to sign the ABN and has demanded that the lab perform the test. Witness #1: Witness #2: 20

23 Billing and reimbursement FORM 8 Document patients refusal to sign ABN (cont.) Include this language every time a patient refuses to sign an ABN. The attestation and signatures should be placed on the face of the ABN wherever enough room is available. 6. Sign attestation, along with second witness. After [choose one: writing or stamping] the attestation provided in paragraph five on the face of the ABN, you and the witness should sign the attestation on the witness lines. If you use a telephone witness, send the ABN to him or her to sign before the requisition is sent to the lab for testing and the billing department for processing. 7. Return requisition to normal billing process. After both witnesses sign the attestation on the ABN, return the requisition (with the ABN attached) and the specimen to the lab s normal testing and billing process. All such specimens and claims shall be processed as if the patient had signed the ABN. 21

24 C h a p t e r o n e 50 FORMS It is important to protect your lab from incorrect advice from your carrier or intermediary. You can cut the risk of major penalties if your carrier s or intermediary s advice turns out to be bad and you can prove that it was reasonable for you to rely on the advice. As a part of your paper trail of protection, you need a method of confirming oral advice you receive. Use the following model letter to request written confirmation of the advice from the carrier or intermediary. Adapt the letter to your particular circumstances. 9 22

25 Billing and reimbursement FORM 9 Written confirmation of oral advice June 15, 2005 [Insert recipient s name] ABC Carrier P.O. Box 1234 Anytown, USA Re: Medicare billing inquiry Dear [insert name]: On March 12, 2005, at 2 p.m., [insert name], billing manager of my office, had a telephone conversation with [insert name and title], regarding a Medicare billing question. As [insert name], explained during the phone conversation, the following situation arose: [insert relevant facts and circumstances that led to your question]. She then asked [insert name], the following question: [insert the Medicare billing question discussed during the phone call]. After discussing the question, facts, and circumstances, [insert name], advised us as follows: [insert a clear, accurate statement of the advice]. So we may determine whether it s reasonable to rely on this advice when submitting future Medicare reimbursement claims, we ask that you confirm that this is ABC Carrier s official advice. So we may fully understand your answer and minimize any future billing misunderstandings, if there are any statutes, regulations, or written policies that are relevant to this question, we ask that you supply us with their citations so we may review them. 23

26 C h a p t e r o n e FORM 9 Written confirmation of oral advice (cont.) If this letter accurately reflects your company s advice to us regarding our Medicare billing question, please sign the confirmation below and return this letter to me in the enclosed selfaddressed, stamped envelope. A copy of this letter is enclosed for your records. If we receive no response to this letter within [insert #] business days, this office will assume that the oral instructions as set forth in this letter are correct and that it is reasonable for us to rely on the advice and act accordingly. Thank you for your cooperation in this matter. Yours truly, [insert name and title here], XYZ Laboratories Confirmation I hereby confirm that I have read the foregoing and that it accurately states ABC Carrier s advice concerning the Medicare inquiry referred to in this letter. Signature Date 24

27 Billing and reimbursement 50 FORMS Take time to periodically examine the technical aspects of your lab s operations to avoid compliance trouble. One potential trouble area is your chargemaster. If it assigns the wrong billing price or CPT /HCPCS code because you didn t update it to reflect coding changes, you will wind up with denied claims/potentially serious compliance problems. Use the following model checklist to make sure employees hit all of the important points when conducting chargemaster evaluations and updates

28 C h a p t e r o n e FORM 10 Chargemaster evaluation and update checklist As part of XYZ Laboratories ongoing compliance commitment, it s essential that we maintain accuracy in our billing and coding operations. Because the chargemaster is the last link in the billing chain, it s especially important for us to periodically evaluate the information in it and to update it with the latest CPT /HCPCS coding changes. When conducting chargemaster evaluations and updates, use the checklist below to make sure your evaluation is as comprehensive as possible. q q Print out a complete copy of the current chargemaster report. Collect the reference materials you ll need to ensure accurate chargemaster CPT /HCPCS coding and billing: q q q Current CPT /HCPCS code books Fiscal intermediary or carrier bulletins for review of LMRPs/LCDs, coding changes, and carrier/intermediary specific billing and coding requirements Current Medicare outpatient fee schedule q Review each line item on the chargemaster report for accuracy in the following areas: q q q q CPT /HCPCS coding Performed procedures that aren t listed Listed procedures that aren t assigned a revenue or CPT /HCPCS code Procedures that are listed as separate charges but should be bundled or deleted, or that aren t reimbursed by Medicare 26

29 Billing and reimbursement FORM 10 Chargemaster evaluation and update checklist (cont.) q q q Procedure description Revenue code assignment (for a hospital lab) Charge amount q q Coordinate changes to chargemaster report with MIS, finance, medical records, or any other necessary departments After changes have been processed, examine any denied claim returned to the lab in the billing cycle immediately following chargemaster updating. Determine whether the chargemaster s failure to process the coding changes properly caused the denial. If so, correct chargemaster entries. 27

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