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Apheresis Reimbursement: Guide to Billing and Securing

Appropriate Payment

May 24, 2013

Keith Berman, MPH, MBA

Health Research Associates

Pasadena, CA

(626) 564-0456

[email protected]

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 Procedure Codes 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 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

CPT Description

36511 Therapeutic apheresis;

for white blood cells


36513 for platelets


36516 with extracorporeal selective adsorption/filtration + plasma reinfusion (LDL apheresis)


Hospital Inpatient (generally)

Hospital Inpatient, Hospital

Outpatient or Physician

Office

Therapeutic Apheresis: Crosswalk to ICD-9-CM Procedure Codes

CPT Description

36511 Therapeutic apheresis;

for white blood cells


36513 for platelets




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

*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

also 202.2X; Sézary disease

Plasma exchange (CPT 36514)

Photopheresis (CPT 36522)

LDL apheresis (CPT 36516)

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

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

67 PRIN. DIAG. CD.

68 CODE

69 CODE

OTHER DIAG.

70 CODE

202.14

80 PRINCIPAL

CODE

PROCEDURE

DATE

81 OTHER

CODE

PROCEDURE

DATE

OTHER

CODE

PROCED

DATE

99.88

A

B

Therapeutic plasma

exchange

CPT code

ICD-9-CM

procedure code

$990 cost x 2.5

charge-to-cost ratio

(in this example)

Myasthenia gravis ICD-9-CM

diagnosis code

Revenue

code

CPT Description



36513 for platelets


38206 Blood-derived hematopoietic stem cell harvesting; autologous1

APC 0111 (blood

product exchange)

Medicare (Hospital Outpatients): 2013 Plasma/Cellular Apheresis Payment

$9512

(U.S. average)

1Allogeneic blood-derived hematopoietic stem cell harvesting is not covered by Medicare under the hospital outpatient prospective payment system (OPPS)

2Medicare payment rate varies by locality: e.g. about $1,140 in Manhattan; $870 in Pittsburgh

Plasma Exchange: 2013 Medicare Hospital Outpatient Payment

CPT/HCPCS Description

36514 Therapeutic apheresis; for plasmapheresis

+

P9045 Infusion, albumin (human), 5%, 250 ml [14 units infused]

Example: Human albumin used as plasma replacement fluid1

Medicare assigns:

2013 U.S. average rate:2

APC 0111 $951

APC 0963 $47.73 x 14

= $668

1Procedures that use cryo-poor plasma would use HCPCS code P9044 2Varies by geographic area in accordance with a local wage index-based formula

Total: $1,619

+

Photopheresis and LDL Apheresis: 2013 Medicare Hospital Outpatient Payment

CPT/HCPCS Procedure Medicare assigns:

2013 U.S. average rate:*

APC 0112

$2,889

*Varies by locality in accordance with a local wage index-based formula

36516 LDL apheresis

36522 Photopheresis

All procedure-related costs are paid under APC 0112

LDL Apheresis: Hospitals Continue to Underreport Costs

*For Medicare outpatient claims for the period 1/2011 – 12/2011

36522 Photopheresis

36516 LDL apheresis

$3,050 $2,889

$1,792

CPT code

Procedure

Reported median cost*

2013 payment rate

Some hospitals are also underreporting plasma exchange and photopheresis costs

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

67 PRIN. DIAG. CD.

68 CODE

69 CODE

OTHER DIAG.

70 CODE

CODES

71 CODE

72 CODE

73 C

357.0

80 PRINCIPAL

CODE

PROCEDURE

DATE

81 OTHER

CODE

PROCEDURE

DATE

OTHER

CODE

PROCED

DATE

99.71

A

B

Guillain-Barré syndrome

Therapeutic plasma pheresis

Groups to:

MS-DRG 0961

(~$11,000)2

Scenario 1: A Guillain-Barré patient without complications or comorbidities is exchanged 5 times over his 11-day stay

1Bacterial and Tuberculous Infections of Nervous System without complication/comorbidities (CCs) or major CCs

2Approximation of U.S. average 2013 base payment rate; varies significantly by institution

Other diagnoses including complications/comorbidities (CCs) and/or major CCs

How Diagnosis Coding of an Inpatient Stay

Yields an MS-DRG Assignment and Payment

67 PRIN. DIAG. CD.

68 CODE

69 CODE

OTHER DIAG.

70 CODE

CODES

71 CODE

72 CODE

73 C

357.0 481

80 PRINCIPAL

CODE

PROCEDURE

DATE

81 OTHER

CODE

PROCEDURE

DATE

OTHER

CODE

PROCED

DATE

99.71

A

B


Therapeutic plasma pheresis

Pneumococcal pneumonia

Scenario 2: A Guillain-Barré patient with pneumococcal pneumonia is exchanged 5 times over his 19-day stay

Groups to:

MS-DRG 0941

(~$19,250)2

1Bacterial and Tuberculous Infections of Nervous System with major complication/comorbidities

2Approximation 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.:


Moderate-severe MG with worsening weakness

Physician Billing for Apheresis Procedure

Supervision

(professional fee)

CPT procedure and

E/M codes

ICD-9-CM diagnosis

codes specifying

diagnosis that relates to

each physician service

or billed item Place of service code

CMS-1500 Claim Form: Key Coding Elements

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



36513 for platelets


36515 with extracorporeal immunoadsorption/plasma reinfusion*



CPT Codes for Blood-Derived Stem Cell Harvesting

CPT Description

38205 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

Apheresis Supervision: General Billing Principles

The physician:

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

*ASFA Guidelines for Documentation of Therapeutic Apheresis Procedures in the Medical Record by Apheresis Physicians (www . apheresis.org)

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.

Understanding & Complying with Medicare’s “Direct, Personal Supervision” Requirement

Medicare Therapeutic Apheresis Coverage Policy Re: The Physician’s Role

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.

“Apheresis is covered…when the following conditions

are met:*

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.”

1American Society for Apheresis. ASFA Announces the Clarification of 1992 National Medicare

Coverage Determination. Accessed at http://www.apheresis.org/apheresis_reimbursement.

242 CFR 410.27(a)(1)(iv).

http://www.apheresis.org/apheresis_reimbursement

Clarifying the Definition of “Immediately Available” for Medicare Apheresis Services

*Medicare Benefit Policy Manual, Chapter 6, Section 20.5.2 (Rev. 143, Effective 5/31/2011).

“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...)”*

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

Evaluation & management (E/M) service

Reviewed/evaluated clinical and lab data relevant to the treatment of the patient that day

Patient history

Made the decision to perform the procedure on that day

Medical decision making

Saw and evaluated the patient for the procedure

Examination

Remained available throughout the duration of the procedure

Billing the Apheresis Supervision and E/M Services on the Same Day by Same Physician

Source: AABB Billing Guide for Transfusion and Cellular Therapy Services. Edition Version 4.0 (October 2007).

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.

Case example:

Code: CPT 36514 (Therapeutic plasmapheresis) ONLY

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.

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:*

446.6

284.8

9922X

36514

25 1

2

Pancytopenia (acquired)

TTP

Initial hospital care (E/M)

Plasma exchange

Significant, separately identifiable E/M service by same physician on same date of the procedure

*and complete both an admitting note and apheresis procedure note

2013 Valuations for Physician Apheresis

Supervision

2013 Valuations for Physician Apheresis Supervision

38205 Harvest allo stem cells 1.50

0.78 2.36

38206 Harvest auto stem cells 0.80 2.41

CPT

Description

MD work RVUs

Facility PE RVUs1

Facility total RVUs

2

36511 Apheresis, leukocyte

1.74

0.83 2.84

36512 Apheresis, red cell 0.84 2.74

36513 Apheresis, platelet 0.83 2.91

1Facility practice expense relative value units (“facility” refers to hospital setting) 2Also includes a malpractice insurance component (0.08 – 0.34 RVU).

36514 Apheresis, plasma 1.74 0.77 2.78

2013 Medicare Average Payment Rates for Physician Apheresis Supervision

36516 LDL apheresis 1.22 0.52 2.09

36522 Photopheresis 1.67 1.21 3.04

CPT

Description

MD work RVUs

Facility PE RVUs1

Facility total RVUs

2

1Facility practice expense relative value units (“facility” refers to hospital setting) 2Also 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

Payment rates vary marginally by geographic locality

Private insurers generally pay similar or higher rates

38205/ 38206

Harvest allogeneic/ autologous stem cells

$82

Special Issues:

Plasma Exchange

Cytapheresis

Photopheresis

LDL Apheresis

Issue:

A number of state Medicaid

programs severely under-

reimburse 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 ultra-

conservative indications for

devices licensed in the mid-1990s

LDL Apheresis: A Yawning Gap Between Insurance Coverage

Policies and Best Clinical Practice?

National Lipid Association Expert

Panel on FH:

For heterozygotes with familial hypercholesterolemia (FH) and very high risk characteristics (CHD, other CV disease, diabetes)

LDL cholesterol 160 mg/dL

Device indication and prevalent insurance coverage policies:

LDL cholesterol 200 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

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.

Photopheresis (ECP) for Post-Lung Transplant BOS: Status of Current Medicare Coverage Initiative

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