Apheresis Reimbursement: Guide to Billing and Securing Appropriate Payment May 24, 2013 Keith Berman, MPH, MBA Health Research Associates Pasadena, CA (626) 564-0456 kberman@sbcglobal.net
Disclaimer Information and examples presented below are for general educational purposes only. They do not constitute advice for actual coding or billing by physicians or hospitals. Insurance billing codes, billing policies, coverage policies and payment rates are subject to change. Providers with questions should consult with representatives of their third party payers before submitting insurance claims.
Educational Objectives Coding basics for therapeutic apheresis services Medicare payment for hospital inpatient/outpatient apheresis Physician apheresis supervision: billing rules and payment Strategies for minimizing/addressing coverage denials Special issues: Plasma exchange and cytapheresis Photopheresis LDL apheresis
Codes: The Shorthand of Insurance Billing CPT codes. 5-digit codes used by physicians and hospitals to bill insurers for outpatient procedures and services. ICD-9-CM procedure codes. Used by hospitals to identify significant procedures during an inpatient stay. ICD-9-CM diagnosis codes. Used to identify diagnoses that are both related and unrelated to the procedure or admission. Revenue codes. 3-digit codes that define the hospital department or service category under which procedures or products are billed.
Hospitals and Physicians Submit Separate Claims for Payment Physicians: CMS-1500 Hospitals: UB-04 Health Insurer
CPT CPT Procedure Codes Description 36511 Therapeutic apheresis; for white blood cells 36512 for red blood cells 36513 for platelets 36514 for plasmapheresis 36515 with extracorporeal immunoadsorption/plasma reinfusion 36516 with extracorporeal selective adsorption or filtration and plasma reinfusion (LDL apheresis) 36522 Photopheresis, extracorporeal 38205 Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic 38206 autologous
Therapeutic Apheresis: Treatment Settings Hospital Inpatient (generally) Hospital Inpatient, Hospital Outpatient or Physician Office CPT 36511 Description Therapeutic apheresis; for white blood cells 36512 for red blood cells 36513 for platelets 36514 for plasmapheresis 36516 with extracorporeal selective adsorption/filtration + plasma reinfusion (LDL apheresis) 36522 Photopheresis, extracorporeal
Therapeutic Apheresis: Crosswalk to ICD-9-CM Procedure Codes CPT 36511 Description Therapeutic apheresis; for white blood cells 36512 for red blood cells 36513 for platelets 36514 for plasmapheresis 36516 with extracorporeal selective adsorption/filtration + plasma reinfusion (LDL apheresis) 36522 Photopheresis, extracorporeal ICD-9 Description 99.72 Therapeutic leukopheresis 99.73 erythrocytapheresis 99.74 plateletpheresis 99.71 plasmapheresis 99.79 Therapeutic apheresis, other 99.88 Therapeutic photopheresis
ICD-9-CM Diagnosis Codes Commonly Referenced in Therapeutic Apheresis Claims* ICD-9 Description 446.6 TTP 357.0 Guillain-Barré syndrome 356.9 CIDP 202.1X Mycosis fungoides 996.85 Graft versus host disease (GvHD) 272.0 Pure hypercholesterolemia Plasma exchange (CPT 36514) Photopheresis (CPT 36522) LDL apheresis (CPT 36516) also 202.2X; Sézary disease *Both hospital and physician claims. Refer to Appendix 2 of ASFA s Therapeutic Apheresis: A Guide to Billing and Securing Appropriate Reimbursement for other commonly referenced diagnosed codes
Medicare Hospital Outpatient Billing and Payment: Ambulatory Payment Classifications (APCs)
Coding the UB-04 Hospital Claim Form for an Outpatient Plasma Exchange Procedure Scenario: A myasthenic patient is exchanged on 5/11/2013 Revenue code 42 REV. CD. 43 DESCRIPTION 44 HCPCS 45 SERV DATE 46 SERV UNITS 47 TOT CHARGES 949 OTHER THER SVS 36514 05/11/13 1 $2,475.00 Myasthenia gravis 67 PRIN. DIAG. CD. 68 CODE 69 CODE 202.14 ICD-9-CM diagnosis code OTHER DIAG. 70 CODE CPT code ICD-9-CM procedure code $990 cost x 2.5 charge-to-cost ratio (in this example) Therapeutic plasma exchange 80 PRINCIPAL CODE PROCEDURE DATE 81 OTHER CODE PROCEDURE DATE 99.88 A B OTHER CODE PROCED DATE
Medicare (Hospital Outpatients): 2013 Plasma/Cellular Apheresis Payment CPT 36511 Description Therapeutic apheresis; for white blood cells 36512 for red blood cells 36513 for platelets 36514 for plasmapheresis 38206 Blood-derived hematopoietic stem cell harvesting; autologous 1 APC 0111 (blood product exchange) $951 2 (U.S. average) 1 Allogeneic blood-derived hematopoietic stem cell harvesting is not covered by Medicare under the hospital outpatient prospective payment system (OPPS) 2 Medicare payment rate varies by locality: e.g. about $1,140 in Manhattan; $870 in Pittsburgh
Plasma Exchange: 2013 Medicare Hospital Outpatient Payment Example: Human albumin used as plasma replacement fluid 1 CPT/HCPCS Description 36514 P9045 Therapeutic apheresis; for plasmapheresis + Infusion, albumin (human), 5%, 250 ml [14 units infused] Medicare assigns: 2013 U.S. average rate: 2 APC 0111 $951 APC 0963 + $47.73 x 14 = $668 Total: $1,619 1 Procedures that use cryo-poor plasma would use HCPCS code P9044 2 Varies by geographic area in accordance with a local wage index-based formula
Photopheresis and LDL Apheresis: 2013 Medicare Hospital Outpatient Payment CPT/HCPCS Procedure 36516 LDL apheresis 36522 Photopheresis Medicare assigns: APC 0112 2013 U.S. average rate:* $2,889 All procedure-related costs are paid under APC 0112 *Varies by locality in accordance with a local wage index-based formula
LDL Apheresis: Hospitals Continue to Underreport Costs CPT code Procedure 36522 Photopheresis 36516 LDL apheresis Reported median cost* $3,050 $1,792 2013 payment rate $2,889 Some hospitals are also underreporting plasma exchange and photopheresis costs *For Medicare outpatient claims for the period 1/2011 12/2011
Outpatient Apheresis: Commercial Insurers May Require Preauthorization Necessary documentation may include: Detailed patient history Examination findings Treatment records Laboratory records Published evidence of clinical benefit Scope of coverage the covered time period or number of treatments can vary by insurer
The Coverage Appeals Process: Get What the Patient Needs; Educate the Insurer Insurer coverage policies often lag behind or miss recent published evidence in the clinical literature Don t give up when an insurer denies coverage: Ask for review on an individual consideration basis Provide available published studies to document efficacy As applicable, document failures with other treatment options Current examples: Plasma exchange for treatment of NMO, relapsing MS LDL apheresis for very high LP(a) Photopheresis for drug-refractory post-lung transplant BOS
Medicare Hospital Inpatient Billing and Payment: Ambulatory Payment Classifications (APCs)
Medicare Payment for Hospital Inpatients: All-Inclusive MS-DRGs 745 MS-DRGs (Medicare Severity-Adjusted Diagnosis-Related Groups) Presence of (1) complications and comorbidities (CCs), (2) major CCs or (3) no CCs can now dictate up to three MS-DRGs with differing payment rates Defining MS-DRGs with CCs and MCCs helps Medicare reimbursement on average better approximate actual costs of hospitalization
How Diagnosis Coding of an Inpatient Stay Yields an MS-DRG Assignment and Payment Scenario 1: A Guillain-Barré patient without complications or comorbidities is exchanged 5 times over his 11-day stay Guillain-Barré syndrome Other diagnoses including complications/comorbidities (CCs) and/or major CCs Groups to: MS-DRG 096 1 (~$11,000) 2 67 PRIN. DIAG. CD. 68 CODE 69 CODE 357.0 OTHER DIAG. CODES 70 CODE 71 CODE 72 CODE 73 C 80 PRINCIPAL PROCEDURE 81 OTHER PROCEDURE OTHER PROCED CODE DATE CODE DATE CODE DATE 99.71 A B Therapeutic plasma pheresis 1 Bacterial and Tuberculous Infections of Nervous System without complication/comorbidities (CCs) or major CCs 2 Approximation of U.S. average 2013 base payment rate; varies significantly by institution
How Diagnosis Coding of an Inpatient Stay Yields an MS-DRG Assignment and Payment Scenario 2: A Guillain-Barré patient with pneumococcal pneumonia is exchanged 5 times over his 19-day stay Guillain-Barré syndrome Pneumococcal pneumonia Groups to: MS-DRG 094 1 (~$19,250) 2 67 PRIN. DIAG. CD. 68 CODE 69 CODE 357.0 481 OTHER DIAG. CODES 70 CODE 71 CODE 72 CODE 73 C 80 PRINCIPAL PROCEDURE 81 OTHER PROCEDURE OTHER PROCED CODE DATE CODE DATE CODE DATE 99.71 A B Therapeutic plasma pheresis 1 Bacterial and Tuberculous Infections of Nervous System with major complication/comorbidities 2 Approximation of U.S. average 2013 base payment rate; varies significantly by institution
Hospital Inpatients: Apheresis and Drug Costs Are NOT Separately Reimbursed Fixed prospective payment (MS-DRGs, per diems) creates a powerful incentive to minimize costs This has generated interest in plasma exchange as a less costly alternative to IVIG in neurological disorders where shown similarly effective, e.g.: Guillain-Barré syndrome Moderate-severe MG with worsening weakness
Physician Billing for Apheresis Procedure Supervision (professional fee)
CMS-1500 Claim Form: Key Coding Elements Place of service code CPT procedure and E/M codes ICD-9-CM diagnosis codes specifying diagnosis that relates to each physician service or billed item CMS-1500
Correct Coding of Place of Service on the Apheresis Supervision Claim Hospital outpatient: use 22 Hospital inpatient: use 21 Office-based procedure: use 11 CMS-1500
CPT Procedure Codes for Apheresis Billing CPT Description 36511 Therapeutic apheresis; for white blood cells 36512 for red blood cells 36513 for platelets 36514 for plasmapheresis 36515 with extracorporeal immunoadsorption/plasma reinfusion * 36516 with extracorporeal selective adsorption/filtration + plasma reinfusion (LDL apheresis) 36522 Photopheresis, extracorporeal
CPT Codes for Blood-Derived Stem Cell Harvesting CPT 38205 Description Blood-derived hematopoietic progenitor cell harvesting for transplantation; allogeneic 38206 autologous The physician claim for supervision of stem cell harvesting should identify the specific diagnosis (e.g. leukemia, lymphoma, aplastic anemia) for which the planned transplantation procedure is intended. NOTE: Medicare pays for cytapheresis and stem cell harvesting procedures in the hospital setting only
The physician: Apheresis Supervision: General Billing Principles Bills the CPT code applicable for that procedure (e.g. CPT 36514 for plasma exchange) Bills the professional fee for each date he/she supervises an apheresis procedure To bill an apheresis professional fee, the physician must examine the patient and must be [immediately] available during the procedure.* *Gajewski JL, Simmons A, Weinstein R et al. Biol Blood Marrow Transplant 2005 Nov; 11(11):871-80.
Apheresis Supervision: More General Billing Principles The physician should prepare a procedure note documenting his/her services (consistent with the institution s standards) Evaluation & management (E/M) codes should not be used to bill for supervision of apheresis procedures.
Documenting the Apheresis Supervision The physician is responsible for documenting supervision of the procedure in the patient record according to the institution s standards.* The procedure note should document that the physician: 1 1. Reviewed/evaluated clinical and lab data relevant to the treatment of the patient that day. 2. Made the decision to perform the procedure on that day. 3. Saw and evaluated the patient for the procedure. 4. Remained available throughout the duration of the procedure to respond in person to emergencies and other situations requiring his/her presence. *ASFA Guidelines for Documentation of Therapeutic Apheresis Procedures in the Medical Record by Apheresis Physicians (www. apheresis.org)
Understanding & Complying with Medicare s Direct, Personal Supervision Requirement
Medicare Therapeutic Apheresis Coverage Policy Re: The Physician s Role Apheresis is covered when the following conditions are met:* A physician is present to perform medical services and to respond to medical emergencies at all times during patient care hours; Each patient is under the care of a physician; and All nonphysician services are furnished under the direct, personal supervision of a physician. *Medicare National Coverage Determinations Manual, Chapter 1, Part 2, Section 110.14 (Apheresis [Therapeutic Pheresis]), effective 7/30/1992.
Clarifying Medicare s Direct, Personal Supervision Requirement 2010: ASFA asks CMS to clarify the meaning of this term CMS responds: The intent of direct, personal means literally the regulatory definition of direct supervision 1 Direct supervision defined by CMS for Medicare coverage: As of 1/1/2011, direct supervision means that the physician must be immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed. 1 American Society for Apheresis. ASFA Announces the Clarification of 1992 National Medicare Coverage Determination. Accessed at http://www.apheresis.org/apheresis_reimbursement. 2 42 CFR 410.27(a)(1)(iv).
Clarifying the Definition of Immediately Available for Medicare Apheresis Services Immediate availability requires the immediate physical presence of the supervisory physician practitioner. CMS has not specifically defined the word immediate in terms of time or distance Examples of a lack of immediate availability would be situations where the supervisory practitioner is performing another procedure or service that he/she could not interrupt, or where he/she is so physically far away from the location where [apheresis] is being furnished that he/he could not intervene right away...) * *Medicare Benefit Policy Manual, Chapter 6, Section 20.5.2 (Rev. 143, Effective 5/31/2011).
Clarifying the Definition of Immediately Available for Medicare Apheresis Services The supervisory practitioner must judge [his/her] relative location to ensure that he/she is immediately available. A supervisory practitioner may supervise from a physician office or other nonhospital space that is not officially part of the hospital campus where services are being furnished as long as he/she remains immediately available. * * Medicare Benefit Policy Manual, Chapter 6, Section 20.5.2 (Rev. 143, Effective 5/31/2011).
When to Bill and Not Bill Evaluation & Management (E/M) Services
Overlap Between Requirements for Apheresis Supervision and E/M Services Supervision of therapeutic apheresis procedure Reviewed/evaluated clinical and lab data relevant to the treatment of the patient that day Made the decision to perform the procedure on that day Saw and evaluated the patient for the procedure Remained available throughout the duration of the procedure Evaluation & management (E/M) service Patient history Medical decision making Examination
Billing the Apheresis Supervision and E/M Services on the Same Day by Same Physician Billing an E&M code in addition to an apheresis service may be appropriate only when the E&M code is a separately identifiable service that involves more than the evaluation and management portion of the apheresis service. An E&M service must also involve a different diagnosis than the diagnosis for which the apheresis is being performed. Add a 25 modifier* to the billed E&M code on this claim. *Connotes a significant, separately identifiable E/M service by the same physician on the same day of the procedure. Source: AABB Billing Guide for Transfusion and Cellular Therapy Services. Edition Version 4.0 (October 2007).
Case example: A neurologist refers a MG patient to the apheresis physician to evaluate for suitability for plasma exchange. The physician examines the patient and reviews her history and labs. The physician determines that plasma exchange is appropriate therapy. The patient receives her first plasma exchange treatment under the physician s supervision on that same day. Code: CPT 36514 (Therapeutic plasmapheresis) ONLY
Example: Where an E/M Service and Apheresis Supervision Are Billable on the Same Date A hematologist admits a patient with pancytopenia and completes an admitting physical and exam. He makes a diagnosis of TTP. On the same day he plans/supervises a plasma exchange procedure. Code:* Pancytopenia (acquired) TTP 284.8 446.6 9922X 36514 Initial hospital care (E/M) 25 1 2 Plasma exchange *and complete both an admitting note and apheresis procedure note Significant, separately identifiable E/M service by same physician on same date of the procedure
2013 Valuations for Physician Apheresis Supervision
2013 Valuations for Physician Apheresis Supervision CPT Description 36511 Apheresis, leukocyte MD work RVUs Facility PE RVUs 1 Facility total 2 RVUs 0.83 2.84 36512 Apheresis, red cell 1.74 0.84 2.74 36513 Apheresis, platelet 0.83 2.91 36514 Apheresis, plasma 1.74 0.77 2.78 38205 Harvest allo stem cells 0.78 2.36 1.50 38206 Harvest auto stem cells 0.80 2.41 1 Facility practice expense relative value units ( facility refers to hospital setting) 2 Also includes a malpractice insurance component (0.08 0.34 RVU).
2013 Medicare Average Payment Rates for Physician Apheresis Supervision CPT Description MD work RVUs Facility PE RVUs 1 Facility total 2 RVUs 36516 LDL apheresis 1.22 0.52 2.09 36522 Photopheresis 1.67 1.21 3.04 1 Facility practice expense relative value units ( facility refers to hospital setting) 2 Also includes malpractice insurance (0.16 RVU for photopheresis, 0.35 RVU for LDL).
2013 U.S. Average Medicare Payment Rates for Physician Apheresis Supervision CPT Description U.S. average payment rate 36511 Apheresis, leukocyte $97 36512 Apheresis, red cell $93 36513 Apheresis, platelet $99 36514 Apheresis, plasma $95 36516 LDL apheresis $71 36522 Photopheresis $103 38205/ 38206 Harvest allogeneic/ autologous stem cells $82 Payment rates vary marginally by geographic locality Private insurers generally pay similar or higher rates
Special Issues: Plasma Exchange Cytapheresis Photopheresis LDL Apheresis
Issue: A number of state Medicaid programs severely underreimburse hospitals for plasma exchange and cytapheresis procedures
Issue: 1992 Medicare National Coverage Determination (NCD) for plasma exchange and cytapheresis procedures is 21 years out of date
Missing from the Current 1992-Vintage Medicare Apheresis National Coverage Determination: Plasma exchange/plasmapheresis: Missing numerous ASFA Category I and II indications (e.g. antibody-mediated renal allograft rejection/hla desensitization; PANDAS; NMO; HUS; MS subtypes) Includes improperly defined clinical uses (e.g. acquired myasthenia gravis; chronic relapsing polyneuropathy ) Entirely missing covered uses for RBCX and platelet pheresis Entirely missing LDL apheresis (and no separate NCD)
Issue: Insurance coverage for LDL apheresis still models ultraconservative indications for devices licensed in the mid-1990s
LDL Apheresis: A Yawning Gap Between Insurance Coverage Policies and Best Clinical Practice? For heterozygotes with familial hypercholesterolemia (FH) and very high risk characteristics (CHD, other CV disease, diabetes) Device indication and prevalent insurance coverage policies: LDL cholesterol 200 mg/dl National Lipid Association Expert Panel on FH: LDL cholesterol 160 mg/dl
Coming soon: Extracorporeal Photopheresis (ECP): Medicare Plans to Cover/Pay for ECP to Treat Bronchiolitis Obliterans Syndrome (BOS) in Post-Lung Transplant Patients
Photopheresis: Medicare Coverage History April 1988: Palliative treatment of skin manifestations of CTCL that has not responded to other therapy. Early 2006: Request submitted for reconsideration of photopheresis NCD to add chronic GVHD December 2006: Chronic GVHD refractory to standard immunosuppressive drug treatment
Photopheresis (ECP) for Post-Lung Transplant BOS: Status of Current Medicare Coverage Initiative August 4, 2011: CMS accepts written request for reconsideration of its NCD for ECP to add treatment for lung transplant patients who develop progressive bronchiolitis obliterans syndrome (BOS) refractory to drug treatment. May 2, 2012: CMS posts final Decision Memo: Under its Coverage with Evidence Development (CED) policy, CMS covers ECP for the treatment of BOS following lung allograft transplantation only when ECP is provided under a clinical research study that addresses one or more aspects of the following question: Prospectively, do Medicare beneficiaries who have received lung allografts, developed BOS refractory to standard immunosuppressive therapy, and received ECP, experience improved patient-centered health outcomes as indicated by: Improved FEV1, or decreased rate of decline of FEV1; Improved survival after transplant; and/or Improved quality of life. September 22, 2012: Proposed registry study protocol is under review by CMS.
ECP/BOS: Proposed Registry Study Design Multiple-center, single-arm study to evaluate the efficacy/tolerability of ECP to treat progressive BOS in adult Medicare-eligible lung allograft recipients experiencing declining FEV1 despite treatment with at least one of the following: high-dose steroid, azithromycin, anti-thymocyte globulin or sirolimus. Patients will receive 24 treatments over a 6-month period, with additional treatments thereafter at the discretion of the supervising physician. Spirometric testing data will be captured to assess a single primary endpoint: change in rate of decline in FEV1 over the 6-month period prior to initiation of ECP treatment, and over the 6- and 12-month period following initiation of ECP. Participating study sites will also report all serious adverse events believed to be directly related to ECP therapy. To document a minimum 50% reduction in the rate of decline in FEV1 versus baseline, the study will enroll a minimum of 136 patients over three years.
Questions & discussion