(Medicare Claims Processing Manual)

Note: E11.8 with E11.65 are a cluster BUT since each code on its own justifies the service, the combination is not required together for this policy.   150.6 - Claims Guidance for Payment  (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21)  Covered Bariatric Surgery Procedures for Treatment of Co -Morbid Conditions Related to Morbid Obesity   Contractors shall process covered bariatric surgery claims as follows:   C. Identify bariatric surgery  claims.   Contractors identify inpatient bariatric surgery claims by the presence of ICD -10 diagnosis code E66.01as the primary diagnosis (for morbid obesity) and one of the covered ICD -10 procedure codes listed in 150.3.  Contractors identify practitioner bariatric surgery claims by the presence of ICD -10 diagnosis code E66.01 as the primary diagnosis (for morbid obesity) and one of the covered HCPCS procedure codes listed in 150.2.  D. Perform facility certification validation for all bariatric surgery claims on a pre -pay basis up to and including date of service September 23, 2013.    A list of approved facilities are found at the link noted in section 150.1, section A, above.   E. Review bariatric surgery claims data and determine whether a pre-  or post -pay sample of bariatric surgery claims need further review to assure that the beneficiary has a BMI 35 (Z68.35- Z68.45) (see ICD -10 equivalents above in section 150.5), and at least one co -morbidity related to   obesity.   The A/B MAC medical director may define the appropriate method for addressing the obesity -related co-morbid requirement.   Effective for dates of service on and after September 24, 2013, CMS has removed the certified facility requirements for Bariatric Surgery for Treatment of Co -Morbid Conditions Related to Morbid Obesity.  NOTE: If ICD -10 diagnosis code E66.01 is present, but a covered procedure code (listed in 150.2 or 150.3) is/are not present, the claim is not for bariatric surgery and should be processed under normal procedures.   NOTE: If ICD -10 diagnosis code E66.01 is present, but a covered procedure code (listed in 150.2 or 150.3) is/are not present, the claim is not for bariatric surgery and should be processed under normal procedures.   150.7 - Medicare Summary Notices (MSNs) and Claim Adjustment Reason Codes  (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21)  When rejecting/denying claims because bariatric surgery procedures were performed in an unapproved facility use:   MSN 16.2 -  "This service cannot be paid when provided in this  location/facility."    Claim Adjustment Reason Code 58 -  "Payment adjusted because treatment was deemed by the payer to have been rendered in an inappropriate or invalid place of  service."   Remittance Advice Remark Code N386 -  This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/ search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD.   When rejecting/denying claims for non- covered bariatric surgery procedures use:    MSN16.10 -  Medicare does not pay for this item or  service.    Claim Adjustment Reason Code 50 -  "These are non -covered services because this is not deemed a medical necessity by the payer."   Remittance Advice Remark Code N386 -  This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/ search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD.     When rejecting/denying claims for covered bariatric surgery procedures because the patient did not meet the conditions for coverage use:    MSN 15.4 -  The information provided does not support the need for this service or  item.    Claim Adjustment Reason Code 167 -  "This (these) diagnosis(es) is (are) not  covered    Remittance Advice Remark Code N386 -  This decision was based on a National Coverage Determination (NCD). An NCD provides a coverage determination as to whether a particular item or service is covered. A copy of this policy is available at www.cms.gov/mcd/ search.asp. If you do not have web access, you may contact the contractor to request a copy of the NCD.    Group Code CO  Contractual  Obligation   In addition to the codes listed above, afford appeal rights to all denied parties.   150.8 - A/MAC Billing Requirements (Rev. 2841, Issued: 12- 23-13, Effective: 09 -24-13, Implementation: 12- 17-13)  The A/MAC billing requirements will pay for bariatric surgery only when the services are submitted on the following type of bill (TOB): 11X. Type of facility and setting determines the basis of payment:    For services performed in Indian Health Services inpatient hospitals, TOB 11X under the inpatient prospective payment system (IPPS) is based on the diagnosis -related group (DRG).    For services performed in inpatient hospitals, TOB 11X under IPPS is based on the DRG.    For services performed in IHS critical access hospitals (CAHs), TOB 11X, payment is based on 101% facility specific per diem rate.    For services performed in CAH inpatient hospitals, TOB 11X, payment is based on 101% of reasonable cost.  150.9 - Advance Beneficiary Notice and HINN Information  (Rev. 1233, Issued: 04- 27-07, Effective: 02 -21-06, Implementation: 05- 29-07)  Physicians must be advised that the physician is liable for charges if the surgery is performed in an unapproved facility, unless the beneficiary was informed that he or she would be financially responsible prior to performance for the procedure. The provi der must have the beneficiary sign an advance beneficiary notice (ABN) if the bariatric surgery is performed in an unapproved facility.  Note that the ABN is the appropriate notice for Part B services.   The HINN model language should be adapted to this situation in the sections addressing: description of the care at issue if the surgery is performed on an inpatient basis, in an unapproved facility, to avoid being liable, the provider must issue a HINN. Other content requirements of HINN still apply. Use the HINN letter most appropriate to the overall situation.   160  PTA for Implanting the Carotid Stent  (Rev. 1042, Issued:  08- 25-06; Effective:  03 -17-05; Implementation:  10 -02-06)  160.1  Category B Investigational Device Exemption (IDE) Study Coverage  (Rev. 1925; Issued:  03- 05-10; Effective Date:  12 -09-09; Implementation Date:  04- 05-10)  Effective July 1, 2001, Medicare covers percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stent placement when furnished in accordance with the Food and Drug Administration (FDA) protocols governing Category B Investigationa l Device Exemption (IDE) studies.  The billing for this procedure is based upon how the service is delivered. There are several CPT codes that may be billed depending upon how the procedure is performed. Contractor medical directors should consider what provider education information is nee ded to assist providers on the billing for this service.   Contractors must review their local coverage determinations to ensure that payment is provided for claims for PTA in an FDA- approved clinical study and deny any claims for services for PTA of the carotid artery when provided outside of an FDA -approved clinical study.   As a requirement for Category B IDE coverage, providers must bill a six- digit IDE Number that begins with a G (i.e., G123456). To identify the line as an IDE line, institutional providers must bill this IDE Number on a 0624 Revenue Code line while practi tioners must bill this IDE Number along with a Q0 modifier.   160.2  Post-Approval Study Coverage  (Rev. 1925; Issued:  03- 05-10; Effective Date:  12 -09-09; Implementation Date:  04- 05-10)  Effective October 12, 2004, Medicare covers PTA of the carotid artery concurrent with the placement of an FDA -approved carotid stent and an FDA -approved or  cleared embolic protection device (effective December 9, 2009) for an FDA -approved indication when furnished in accordance with FDA -approved protocols governing post -approval studies. Billing post -approval studies is similar to normal Category B IDE billing procedures, except that under post -approval coverage, providers must bill the Pre -Market Approval  (PMA) number assigned to the stent system by the FDA. PMA numbers are like typical IDE Numbers in that they have six -digits, but they begin with a P (i.e., P123456) instead of a G.   160.2.1  Carotid Artery Stenting (CAS) for Post -Approval Studies  (Rev. 11021; Issued: 10- 01-21; Effective: 10 -29-21; Implementation: 10 -29-21)  A. Background   As the post -approval studies began to end, CMS received requests to extend coverage for the post -approval studies. CMS has reviewed the extension requests and has determined that patients participating in post -approval extension studies are also included in the currently covered population of patients participating in FDA -approved post -approval studies.  B. Policy   To grant approval for post -approval studies, the FDA reviews each study protocol. Once approval is granted, the FDA issues a formal approval letter to the study sponsor. Extensions of post -approval studies are not subject to approval by the FDA because they surpass the post -approval study requirements identified in the conditions of approval for post -approval studies. Since the FDA cannot approve these extension studies, i ndividual Post -Market Approval (PMA) numbers cannot be issued to separately identify each study. Currently, in order to receive reimbursement for procedures performed as part of a carotid artery stenting post -approval study, providers must include the FDA -issued PMA number on each claim to indicate participation in a specific study.    CMS has determined that all extension studies must be reviewed by the FDA.  The FDA will issue an acknowledgement letter stating that the extension study is scientifically valid and will generate clinically relevant post -market data. Upon receipt of this letter and review of the extension study protocol, CMS will issue a letter to the  study sponsor indicating that the study under review will be covered by Medicare.  Since an individual PMA number cannot be assigned by the FDA to each extension study, these studies will use the PMA number assigned to the original FDA -approved post -approval study (i.e., CAPTURE 2  shall use the PMA number assigned to CAPTURE 1).  C. Billing   In order to receive Medicare coverage for patients participating in post -approval extension studies, providers shall submit both the FDA acknowledgement letter and the CMS letter providing coverage for the extension study to their contractor. Additionally, providers shall submit any other materials contractors would require for FDA -approved post - approval studies.  In response, contractors will issue a letter assigning an effective date for each facilitys participation in the extension study. Providers may bill for procedures performed in the extension study for dates of service on and after the assigned effective d ate. Providers billing A/B MACs (A) must bill using the most current ICD-10-CM is applicable, Indications for PTA of the Carotid Artery Concurrent with Stenting (must bill one of these primary codes to meet coverage under 20.7B2, 20.7B3, 20.7B4)