IDENT Type of Document: Type of Policy: Applicability: Sponsor’s Dept: Title of Sponsor Title of Approving Official: Date Released (Published): Next Review Date SUBJECT: LAB COMP 100.004 Policy Department All LAB Adm.Director Director of Laboratory 05/14/2015 05/14/2017 Custom Profiles PURPOSE: The purpose of this policy is to provide guidance to all University of Vermont Medical Center (UVMMC) and billing personnel as to how Custom Profiles are created, maintained and discontinued. POLICY STATEMENT: Custom profiles permit physicians to establish their own test profile, consisting of a particular group of tests, that they order frequently for their own patients. Physicians in certain specialties often have such groupings for particular clinical situations. The government recognizes the need for custom profiles that reflect a physician's test packaging needs. However, the government expects the laboratory that constructs the custom profile to provide a disclosure notice to the physician who uses a custom profile. This disclosure is called a Physician Acknowledgement of Customized Profile. By way of acknowledgement, the physician affirms the understanding that: 1. 2. 3. The tests ordered are medically necessary and will provide the correct ICD-9 code for documentation. Individual tests or a less inclusive profile should be ordered when not all of the tests in the custom profile are medically necessary. The Office of Inspector General (OIG) of the Department of Health and Human Services takes the position that an individual who knowingly causes a false claim to be submitted, may be subject to sanctions and other remedies under civil, criminal or administrative law. The Physician Acknowledgement of Customized Profile form includes the profile name, the test components, the CPT codes billed, the patient price and the Medicare reimbursement amount. This information ensures that the physician has adequate information to make a fully informed test ordering decision and understands the implications of ordering a custom profile. The Laboratory requests that the physician sign a Physician Acknowledgement of Customized Profile when a custom profile is created per physician request and on an annual basis for as long as the physician wishes to order the custom profile. PROCEDURE: 1. All Physicians are requested to sign a Physician Acknowledgement of Customized Profile form if they request the laboratory to create a profile. 2. On an annual basis, the Laboratory Marketing Specialist requests a printout from LIS listing all physicians who use custom profiles. Printed on: 2/2/2016 By: %username% DISCLAIMER: Only the online policy is considered official. Printed policies should be compared with on-line document for accuracy. 3. A Physician Acknowledgement of Customized Profile form is sent to each physician on the list who has ordered the same profile at least three times in the past year. The form describes the particular custom profile the physician has ordered the previous year and requests that the physician signs the form and returns it to the laboratory. 4. If a physician does not return the first form, then a second form is sent with a letter from the Laboratory Compliance Specialist. The letter explains the importance of the Physician Acknowledgement of Customized Profile form and again requests that the physician sign and return the form. 6. The Laboratory makes 2 attempts to obtain a Physician Acknowledgement of Customized Profile. The laboratory’s efforts to obtain the Physician Acknowledgement of Customized Profile is documented by the Laboratory Marketing Specialist and reported to the Laboratory Compliance Specialist. The original paper version of the signed form will be kept for 1 year. Documentation of the lab efforts and physician compliance will also be stored electronically indefinitely. MONITORING PLAN: N/A REFERENCES: OIG Compliance Program Guidance for Clinical Laboratories, August 1998. APPENDICIES: 1. 2. REVIEWERS: Janet Schroeter, MT (ASCP) Laboratory Compliance Specialist Colleen Williams, MLT (ASCP) Laboratory Marketing Specialist Kathy Nadeau, MT (ASCP) Laboratory Compliance Specialist Monica Sullivan, Manager, Clinical Laboratory Chuck Powden, Manager, Clinical Laboratory Tim St. John, Manager, Anatomic Laboratory Lynn Bryan, Manager, Lab Client Services and Customer Service OWNER’S NAME: Tania C. Horton, Administrative Director Physician Acknowledgement of Custom Profiles Follow-up letter to physicians regarding Custom Profiles APPROVING OFFICIAL'S NAME: Mark K. Fung, MD, Director of Clinical Laboratories Printed on: 2/2/2016 By: %username% DISCLAIMER: Only the online policy is considered official. Printed policies should be compared with on-line document for accuracy. Printed on: 2/2/2016 By: %username% DISCLAIMER: Only the online policy is considered official. Printed policies should be compared with on-line document for accuracy. Appendix 1 PHYSICIAN ACKNOWLEDGMENT OF CUSTOMIZED PROFILES You ordered the attached customized profile within the past year (2001). If you wish to continue using this profile, please sign the acknowledgement and return it to the laboratory. As part of the Office of the Inspector General’s compliance guidelines for laboratories, University of Vermont Medical Center laboratory must provide an annual notice to each physician who orders customized testing. By way of this acknowledgment, you affirm your understanding that: 1. 2. You will order only tests that you believe are medically necessary. You will order individual tests or a less inclusive profile when not all tests in a customized profile are medically necessary for an individual patient. You will provide an ICD9 code to document medical necessity for all tests included in the customized profile. The Office of the Inspector General of the Department of Health and Human Services takes the position that an individual who knowingly causes a false claim to be submitted may be subject to sanctions or other remedies under civil, criminal or administrative law. 3. 4. Profile TP1C Thrombosis Panel Components Protime PTT Cardiolipin AB Dilute Viper Venom Thrombin Time Homocysteine At3, Functional Protein C, Functional Protein S, Functional APC Resistance PTT 50/50 Mix Factor 5 Leiden (Digestion) (Extraction) (Interpretation and Report) (PCR) (Separation) CPT Code 85610 85730 86147(X2) 85613 85670 82131 85300 85303 85306 85730(2) 85611 83892 83890 83912 83898 83894 Patient Price $17.00 $21.00 $153.90 $46.48 $35.00 $103.00 $75.00 $125.00 $110.00 $178.80 $53.00 $53.00 $53.76 $53.76 $53.76 $53.76 $1186.22 Medicare Reimbursement $5.43 $8.30 $19.00 $13.22 $6.43 $14.78 $15.69 $17.62 $19.75 $16.60 $5.45 $5.54 $5.54 $5.54 $6.03 $5.54 $170.46 I understand these implications of ordering customized profiles and I request the creation and/or use of the above stated customized profile(s). Provider Name: Provider Signature:______________________________________________ Date: ______________________ Please return signed form to Colleen Williams, Lab, Mercy 204. Contact me with any questions you have regarding this matter. I may be reached at 847-9473 or Colleen.Williams@vtmednet.org. CP tp1c template 2000 November 12, 2001 Printed on: 2/2/2016 By: %username% DISCLAIMER: Only the online policy is considered official. Printed policies should be compared with on-line document for accuracy. Appendix 2 April 2, 2001 Dear Dr. The government expects laboratories that construct custom profiles in response to a physician’s request to provide an annual disclosure notice to the physicians who use the custom panel. This disclosure is called a Physician Acknowledgement of Customized Profile. The purpose of this acknowledgement is to guarantee that physicians have adequate information to make a fully informed test ordering decision. Our laboratory records indicate you have ordered the following customized profile of laboratory tests (see attached sheet) during the past year. We have not received a signed Physician Acknowledgement of Customized Profile from you. We ask that you sign the attached Acknowledgement and return it to the address indicated on the form. Thank you very much for your assistance with our compliance program. Sincerely, Janet Schroeter Laboratory Compliance Specialist 847-9435 Printed on: 2/2/2016 By: %username% DISCLAIMER: Only the online policy is considered official. Printed policies should be compared with on-line document for accuracy.