1. Definition of Acquisition Charges for Allogeneic Stem Cell Transplants

Acquisition charges for allogeneic stem cell transplants include, but are not limited to, charges for the costs of the following services:

• National Marrow Donor Program fees, if applicable, for stem cells from an unrelated donor;

• Tissue typing of donor and recipient;

• Donor evaluation;

• Physician pre-procedure donor evaluation services;

• Costs associated with harvesting procedure (e.g., general routine and special care services, procedure/operating room and other ancillary services, apheresis services,etc.);

• Post-operative/post-procedure evaluation of donor; and

• Preparation and processing of stem cells.

Payment for these acquisition services is included in the OPPS APC payment for the allogeneic stem cell transplant when the transplant occurs in the hospital outpatient setting, and in the MS-DRG payment for the allogeneic stem cell transplant when the transplant occurs in the inpatient setting. The Medicare contractor does not make separate payment for these acquisition services, because hospitals may bill and receive payment only for services provided to the Medicare beneficiary who is the recipient of the stem cell transplant and whose illness is being treated with the stem cell transplant. Unlike the acquisition costs of solid organs for transplant (e.g., hearts and kidneys), which are paid on a reasonable cost basis, acquisition costs for allogeneic stem cells are included in prospective payment. Recurring update notifications describing changes to and billing instructions for various payment policies implemented in the OPPS are issues annually.

Acquisition charges for stem cell transplants apply only to allogeneic transplants, for which stem cells are obtained from a donor (other than the recipient himself or herself). Acquisition charges do not apply to autologous transplants (transplanted stem cells are obtained from the recipient himself or herself), because autologous transplants involve services provided to the beneficiary only (and not to a donor), for which the hospital may bill and receive payment (see Pub. 100-04, chapter 3, §90.3.1 and §231.10 of this chapter for information regarding billing for autologous stem cell transplants).



2. Billing for Acquisition Services

The hospital bills and shows acquisition charges for allogeneic stem cell transplants based on the status of the patient (i.e., inpatient or outpatient) when the transplant is furnished. See Pub. 100-04, chapter 3, §90.3.1 for instructions regarding billing for acquisition services for allogeneic stem cell transplants that are performed in the inpatient setting.

When the allogeneic stem cell transplant occurs in the outpatient setting, the hospital identifies stem cell acquisition charges for allogeneic bone marrow/stem cell transplants separately in FL 42 of Form CMS-1450 (or electronic equivalent) by using revenue code 0819 (Other Organ Acquisition). Revenue code 0819 charges should include all services required to acquire stem cells from a donor, as defined above, and should be reported on the same date of service as the transplant procedure in order to be appropriately packaged for paymentpurposes.

The transplant hospital keeps an itemized statement that identifies the services furnished, the charges, the person receiving the service (donor/recipient), and whether this is a potential transplant donor or recipient. These charges will be reflected in the transplant hospital's stem cell/bone marrow acquisition cost center. For allogeneic stem cell acquisition services in cases that do not result in transplant, due to death of the intended recipient or other causes, hospitals include the costs associated with the acquisition services on the Medicare cost report.

In the case of an allogeneic transplant in the hospital outpatient setting, the hospital reports the transplant itself with the appropriate Procedure  code, and a charge under revenue center code 0362 or another appropriate cost center. Selection of the cost center is up to the hospital.

Medicare Credit Balance Report – Provider Instructions


General

The Paperwork Burden Reduction Act of 1995 was enacted to inform you about why the Government collects information and how it uses the information.  In accordance with sections 1815(a) and 1833(e) of the Social Security Act (the Act), the Secretary is authorized to request information from participating providers that is necessary to properly administer the Medicare program.

In addition, section 1866(a)(1)(C) of the Act requires participating providers to furnish information about payments made to them, and to refund any monies incorrectly paid. In accordance with these provisions, all providers participating in the Medicare program are to complete a Medicare Credit Balance Report (CMS-838) to help ensure that monies owed to Medicare are repaid in a timely manner.

The CMS-838 is specifically used to monitor identification and recovery of “credit balances” owed to Medicare. A credit balance is an improper or excess payment made to a provider as the result of patient billing or claims processing errors. Examples of Medicare credit balances include instances where a provider is:

• Paid twice for the same service either by Medicare or by Medicare and another insurer;

• Paid for services planned but not performed or for non-covered services;

• Overpaid because of errors made in calculating beneficiary deductible and/or coinsurance amounts; or

• A hospital that bills and is paid for outpatient services included in a beneficiary’s inpatient claim. Credit balances would not include proper payments made by Medicare in excess of a provider’s charges such as DRG payments made to hospitals under the Medicare prospective payment system. For purposes of completing the CMS-838, a Medicare credit balance is an amount determined to be refundable to Medicare.

Generally, when a provider receives an improper or excess payment for a claim, it is reflected in their accounting records (patient accounts receivable) as a “credit.” However, Medicare credit balances include monies due the program regardless of its classification in a provider’s accounting records. For example, if a provider maintains credit balance accounts for a stipulated period; e.g., 90 days, and then transfers the accounts or writes them off to a holding account, this does not relieve the provider of its liability to the program. In these instances, the provider must identify and repay all monies due the Medicare program.

Only Medicare credit balances are reported on the CMS-838. 

To help determine whether a refund is due to Medicare, another insurer, the patient, or beneficiary, refer to the sections of the manual [each provider manual will have the appropriate cite for that manual] that pertain to eligibility and Medicare Secondary Payer (MSP) admissions procedures.

Submitting the CMS-838

Submit a completed CMS-838 to your fiscal intermediary (FI) within 30 days after the close of each calendar quarter. Include in the report all Medicare credit balances shown in your accounting records (including transfer, holding or other general accounts used to accumulate credit balance funds) as of the last day of the reporting quarter.

Report all Medicare credit balances shown in your records regardless of when they occurred. You are responsible for reporting and repaying all improper or excess payments you have received from the time you began participating in the Medicare program. Once you identify and report a credit balance on the CMS-838 report, do not report the same credit balance on subsequent CMS-838 reports.

Completing the CMS-838

The CMS-838 consists of a certification page and a detail page. An officer (the Chief Financial Officer or Chief Executive Officer) or the Administrator of your facility must sign and date the certification page. Even if no Medicare credit balances are shown in your records for the reporting quarter, you must still have the form signed and submitted to your FI in attestation of this fact. Only a signed certification page needs to be submitted if your facility has no Medicare credit balances as of the last day of the reporting quarter. An electronic file (or hard copy) of the certification page is available from your FI.

The detail page requires specific information on each credit balance on a claim-by-claim basis. This page provides space to address 17 claims, but you may add additional lines or reproduce the form as many times as necessary to accommodate all of the credit balances that you have reported. An electronic file (or hard copy) of the detail page is available from your FI.

You may submit the detail page(s) on a diskette furnished by your contractor or by a secure electronic transmission as long as the transmission method and format are acceptable to your FI. Segregate Part A credit balances from Part B credit balances by reporting them on separate detail pages.

NOTE: Part B pertains only to services you provide which are billed to your FI. It does not pertain to physician and supplier services billed to carriers.

Begin completing the CMS-838 by providing the information required in the heading area of the detail page(s) as follows:

• The full name of the facility;

• The facility’s provider number. If there are multiple provider numbers for dedicated units within the facility (e.g., psychiatric, physical medicine and rehabilitation), complete a separate Medicare Credit Balance Report for each provider number;

• The month, day and year of the reporting quarter; e.g., 12/31/02;

• An “A” if the report page(s) reflects Medicare Part A credit balances, or a “B” if it reflects Part B credit balances;

• The number of the current detail page and the total number of pages forwarded, excluding the certification page (e.g., Page 1 of 3); and

• The name and telephone number of the individual who may be contacted regarding any questions that may arise with respect to the credit balance data.

Complete the data fields for each Medicare credit balance by providing the following information (when a credit balance is the result of a duplicate Medicare primary payment, report the data pertaining to the most recently paid claim):

Column 1 - The last name and first initial of the Medicare Beneficiary, (e.g., Doe, J.).

Column 2 - The Medicare Health Insurance Claim Number (HICN) of the Medicare Beneficiary.

Column 3 - The multiple-digit Internal Control Number (ICN) assigned by Medicare when the claim is processed.

Column 4 - The 3-digit number explaining the type of bill; e.g., 111 - inpatient, 131 - outpatient, 831 - same day surgery. (See the Uniform Billing instructions, [each provider manual has the appropriate cite for the manual].)

Columns 5/6 - The month, day and year the beneficiary was admitted and discharged, if an inpatient claim; or “From” and “Through” dates (date service(s) were rendered), if an outpatient service. Numerically indicate the admission (From) and discharge (Through) date (e.g., 01/01/02).

Column 7 - The month, day and year (e.g., 01/01/02) the claim was paid. If a credit balance is caused by a duplicate Medicare payment, ensure the paid date and ICN number correspond to the most recent payment.

Column 8 - An “O” if the claim is for an open Medicare cost reporting period, or a “C” if the claim pertains to a closed cost reporting period. (An open cost report is one where an NPR has not yet been issued. Do not consider a cost report open if it was reopened for a specific issue such as graduate medical education or malpractice insurance.)

Column 9 - The amount of the Medicare credit balance that was determined from your patient/ accounting records.

Column 10 - The amount of the Medicare credit balance identified in column 9 being repaid with the submission of the report. (As discussed below, repay Medicare credit balances at the time you submit the CMS-838 to your FI.)

Column 11 - A “C” when you submit a check with the CMS-838 to repay the credit balance amount shown in column 9, an “A” if a claim adjustment is being submitted in hard copy (e.g., adjustment bill in UB-92 format) with the CMS-838, and a “Z” if payment is being made by a combination of check and adjustment bill with the CMS-838. Use an “X” if an adjustment bill has already been submitted electronically or by hard copy.

Column 12 - The amount of the Medicare credit balance that remains outstanding (column 9 minus column 10). Show a zero (“0”) if you made full payment with the CMS-838 or a claim adjustment had been submitted previously, including electronically.

Column 13 - The reason for the Medicare credit balance by entering a “1” if it is the result of duplicate Medicare payments, a “2” for a primary payment by another insurer, or a “3” for “other reasons.” Provide an explanation on the detail page for each credit balance with a “3.”

Column 14 - The Value Code to which the primary payment relates, using the appropriate two digit code as follows: (This column is completed only if the credit balance was caused by a payment when Medicare was not the primary payer. If more than one code applies, enter the code applicable to the payer with the largest liability. For code description, see [each provider manual has the appropriate cite for that manual].)

12 – Working Aged

13 – End Stage Renal Disease

14 – Auto/No Fault

15 – Workers’ Compensation

16 – Other Government Program

41 – Black Lung

42 – Department of Veterans Affairs (VA)

43 – Disability

44 – Conditional Payment

47 – Liability


Column 15 - The name and billing address of the primary insurer identified in column 14.

NOTE: Once a credit balance is reported on the CMS-838, it is not to be reported on a subsequent
 period report.


Payment of Amounts Owed Medicare

Providers must pay all amounts owed (column 9 of the report) at the time the credit balance report is submitted.

Providers must submit payment, by check or adjustment bill.

• Payments by check must also be accompanied by a separate adjustment bill, electronic or hard copy, for all individual credit balances that pertain to open cost reporting periods. The FI will ensure that the monies are not collected twice.

• Submission of the detail information on the CMS-838 will not be accepted by the FI as an
 adjustment bill.


• Claim adjustments, whether as payment or in connection with a check, must be submitted as adjustment bills (electronic or hard copy). If the claim adjustment was submitted electronically, this must be shown on the CMS-838 (see instructions for column 11).

• There is a limited exception for MSP credit balances. Federal regulations at 42 CFR 489.20(h) state that “if a provider receives payment for the same services from Medicare and another payer that is primary to Medicare…” the provider must identify MSP related credit balances in the report for the quarter in which the credit balance was identified, even if repayment is not required until after the date the report is due. If the provider is not submitting a payment (by check or adjustment bill) for an MSP credit balance with the CMS-838 because of the 60-day rule, the provider must furnish the date the credit balance was received. Otherwise, the FI must assume that the payment is due and will issue a recovery demand letter and accrue interest without taking this 60-day period into consideration.

• If the amount owed Medicare is so large that immediate repayment would cause financial hardship, you may contact your FI regarding an extended repayment schedule.

Records Supporting CMS-838 Data


Develop and maintain documentation that shows that each patient record with a credit balance (e.g.,
 transfer, holding account) was reviewed to determine credit balances attributable to Medicare and the   amount owed, for the preparation of the CMS-838. At a minimum, your procedures should:


• Identify whether the patient is an eligible Medicare beneficiary;
• Identify other liable insurers and the primary payer;
• Adhere to applicable Medicare payment rules; and
• Ensure that the credit balance is due and refundable to Medicare.

NOTE: A suspension of Medicare payments may be imposed and your eligibility to participate in the Medicare program may be affected for failing to submit the CMS-838 or for not maintaining documentation that adequately supports the credit balance data reported to CMS. Your FI will review your documentation during audits/reviews performed for cost report settlement purposes. Provider Based Home Health Agencies (HHAs) Provider-based HHAs are to submit their CMS-838 to their Regional Home Health Intermediary even though it may be different from the FI servicing the parent facility.

Exception for Low Utilization Providers

Providers with extremely low Medicare utilization do not have to submit a CMS-838. A low utilization provider is defined as a facility that files a low utilization Medicare cost report as specified in PRM-I, section 2414.4.B, or files less than 25 Medicare claims per year.

Compliance with MSP Regulations

MSP regulations at 42 CFR 489.20(h) require you to pay Medicare within 60 days from the date you receive payment from another payer (primary to Medicare) for the same service. Submission of the CMS-838 and adherence to CMS’ instructions do not interfere with this rule. You must repay credit balances resulting from MSP payments within the 60-day period.

Report credit balances resulting from MSP payments on the CMS-838 if they have not been repaid by the last day of the reporting quarter. If you identify and repay an MSP credit balance within a reporting quarter, in accordance with the 60-day requirement, do not include it on the CMS-838; i.e., once payment is made, a credit balance would no longer be reflected in your records.

If an MSP credit balance occurs late in a reporting quarter, and the CMS-838 is due prior to expiration of the 60-day requirement, include it in the credit balance report. However, payment of the credit balance does not have to be made at the time you submit the CMS-838, but within the 60 days allowed.

Why is Ohio Medicaid requiring Ordering, Referring, and Prescribing Providers (ORP Providers) to enroll as Ohio Medicaid providers?

This is being done in order to comply with program integrity provisions of the Affordable Care Act (ACA), specifically section 6401 which is found in the Code of Federal Regulations: 42 CFR § 455.410(b): “The State Medicaid agency must require all ordering or referring physicians or other professionals providing services under the State plan or under a waiver of the plan in the fee-for-service program to be enrolled as participating Medicaid providers.” As a result, ORP providers will undergo a screening process to improve  program integrity and reduce fraud, waste and abuse. This screening process includes a review of federal exclusion lists and other databases that would prohibit an excluded healthcare professional from being associated with Medicare or Medicaid.
What are the requirements for ORP**

There are three basic requirements:

** The physician or non-physician practitioner who wrote the order, referral or prescription must be enrolled as either a Medicaid billing provider or as an ORP-only (non-billing) provider and their NPI and NAME must be included on claims submitted to the department.

** The provider's NPI must be for an individual physician or non-physician practitioner (not an organizational NPI).

** The physician or non-physician practitioner must be of a specialty type that is eligible to order, refer, or prescribe.

Does the Ohio Department of Medicaid have a list of provider types that are eligible to be ORP providers**

Currently, the list of eligible OPR Providers includes:

** Licensed Doctors of Medicine/Osteopathy – (Provider Type 20)
** Licensed Doctors of Chiropractic – (Provider Type 27)
** Licensed Doctors of Dental Medicine/Surgery- (Provider Type 30)
** Licensed Doctors of Podiatric Medicine- (Provider Type 36)
** Licensed Doctors of Optometry- (Provider Type 35)
** Licensed Physician Assistants- (Provider Type 24)
** Licensed Nurse Practitioners- (Provider Type 72)
** Licensed Clinical Nurse Specialists- (Provider Type 65)
** Licensed Certified Nurse Midwifes- (Provider Type 71)
** Licensed Clinical Psychologists- (Provider Type 42)

Note: Organizational providers are prohibited from ordering, referring, or prescribing medications

Additional provider and supplier requirements for enrolling and maintaining active enrollment status in the Medicare program. (f) Maintaining and providing access to documentation.

(1) A provider or a supplier who furnishes covered ordered DMEPOS or referred home health, laboratory, imaging, or specialist services is required to maintain documentation for 7 years from the date of service and, upon the request of CMS or a Medicare contractor, to provide access to that documentation. The documentation includes written and electronic documents (including the NPI of the physician who ordered the home health  services and the NPI of the physician or the eligible professional who ordered or referred the DMEPOS, laboratory, imaging, or specialist services) relating to written orders and requests for payments for items of DMEPOS and home health, laboratory, imaging, and specialist services.

(2) A physician who ordered home health services and a physician and an eligible professional who ordered or referred items of DMEPOS or laboratory, imaging, and specialist services is required to maintain documentation for 7 years from the date of the order, certification, or referral and, upon request of CMS or a Medicare contractor, to provide access to that documentation. The documentation includes written and electronic documents (including the NPI of the physician who ordered the home health services and the NPI of the physician or the eligible professional who ordered or referred the DMEPOS, laboratory, imaging, or specialist services) relating to written orders or requests for payments for items of DMEPOS and home health, laboratory, imaging, and specialist services.

The Office of the Inspector General (OIG) U.S. Department of Health and Human Services provides physician educational resources on physician relationships with payers and vendors. These resources are found here: http://oig.hhs.gov/compliance/physician-education/index.asp. The educational information discusses maintaining and providing documentation as well as the importance of legitimate prescriptions for patients.

As a billing provider/supplier, if you are asked and/or required to pay for or refused documentation by a referring/ordering physician, please report the incident as potential fraud and/or abuse. As a referring/ordering physician, if you are asked to sign or write prescriptions for Medicare beneficiaries by a provider/supplier for unnecessary services/items or for patients you do not know, please report the incident.

Executive Summary

When physicians believe their patients may require the expertise of another physician, effective, timely and informative communication between all physicians is essential to ensure appropriate use of specialty care services. The results of physician surveys indicate a lack of informative referral communication exists in Canada. Significant variation exists in referral request processes*. This is contributing to the poor access to specialty care that many patients are experiencing.

Some of this variation is necessary, however, which means that a single, standardized solution to improve the entire referral and consultation process is not feasible. Nonetheless, while communication processes and information requirements for referral requests vary considerably, the communication and information needs in consultant responses is essentially the same for all referring physicians. Unfortunately, provision of this information is often lacking. This problem can be addressed through standard communication protocols because all referring physicians benefit from receiving the same types of information in response to referral requests; for example, acknowledgement of referral receipt or patient consult reports.

Furthermore, when referrals are initiated, specific types of requests can benefit from standardization of communication methods and information requirements. Such activities are already underway in Canada in select areas. These successful initiatives, used together as complementary approaches to address the varying needs of referral requests, should be adopted throughout the country.

RECOMMENDATIONS

** All stakeholders, especially physicians, but also, where appropriate, office assistants, nurses, other health care providers as well as patients, must be engaged in an early and meaningful way regarding any initiative that has a goal to improve referral or consultation processes.

** There is no single best way to access specialist expertise; as a result, a combination of complementary initiatives (e.g., formal consultation systems, standardized referral processes with central intake systems and/or physician directories) should be implemented to reduce variation in the approaches that are used and to facilitate more timely access to specialty care for patients.

** While acknowledging the referring physician’s ability to interpret certain test results, the referral must be accompanied by appropriate information to allow the consulting specialist to fully assess the request, and the referring physician must be informed of what is “appropriate”.

** The referring physician (and family physician if different), as well as the patient, should be kept informed, in a timely fashion, of the status of the referral request, using standardized procedures, minimum information requirements and timelines.

** Physician and/or physician practices should receive compensation and support in recognition of the time and effort undertaken to communicate appropriate information regarding referral requests as well as to conduct electronic or real-time consultations.

The most appropriate method of communication differs depending on the degree of specialist involvement that is required. There are no standards about which method of communication is the most appropriate or effective, or what information is required, for each situation. Referral request processes† vary significantly; not only across specialties but among specialists within a particular specialty and even within a geographic region.

Examples of this variation include: some consulting specialists will accept referrals only if the referring physician has used their specific referral form; others accept referrals using only one particular communication method (e.g., by fax); and others accept referrals on just one day each month. Such variation creates inefficiencies because referring physicians must familiarize themselves with each request process that is required by each consulting specialist.

The range and quality of information provided in a referral request also varies considerably; for example, too little information (i.e. no reason for referral provided), insufficient information (i.e. out-of-date or a lack of lab or imaging tests), or to too much information (i.e. noncontributory family history).

This lack of standardization is problematic. In this context, standardization means simplification rather than obligation. Standardized processes facilitate communications for referrals by removing ambiguities about which method is most appropriate for each situation.

Communication methods and the types of information that are transferred between referring physicians and consulting specialists vary based on numerous factors, ranging from those beyond the control of physicians such as regulations and available technology, to those completely within their control such as their own individual preferences.

An effective way to facilitate appropriate and timely access to specialty care that is within the control of the health care profession is to explore the rationale behind these varying communication and information preferences and address these variations by developing, with meaningful participation and approval from physicians and their administrative staff, standard processes for requesting a specialist referral and for communicating back to the referring physician.

Procedure  Codes and Description

Group 1 Paragraph: Note: The American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS) require the use of short CPT descriptors in policies published on the Web. For CPT code long descriptors, refer to the current version of CPT.

Group 1 Codes:

88182Cell marker study
88184Flowcytometry/ tc 1 marker
88185Flowcytometry/tc add-on
88187Flowcytometry/read 2-8
88188Flowcytometry/read 9-15
88189Flowcytometry/read 16 & >


Coverage Indications, Limitations, and/or Medical Necessity

Flow cytometry (FCM) is a complex process to examine blood, body fluids, CSF, bone marrow, lymph node, tonsil, spleen and other solid tissues. The use of peripheral blood and fine needle aspirate material avoids more invasive procedures for diagnosis.

A flow cytometer evaluates the physical and/or chemical characteristics of single cells as the cells pass individually in a fluid stream through a measuring device. Surface receptors, intracellular molecules, and DNA bind with fluorescent dyes that allow detection and evaluation.

When light of one wave length excites electrons of certain chemicals to energy levels above their ground state and upon return to ground state emits light of a longer wavelength, fluorescence is produced. A flow cytometer detects cell characteristics by measuring the fluorescence produced by fluorochromes conjugated either directly with cell components or conjugated to antibodies directed against cell components.

Indications
Cytopenias and Hypercellular Hematolymphoid Disorders

Hematolymphoid neoplasia can present with cytopenias (anemia, leucopenia and/or thrombocytopenia) or elevated leukocyte counts. If medical review and preliminary laboratory testing fails to reveal a cause, bone marrow aspiration and biopsy are indicated to rule out an infiltrative process or a stem cell disorder. FCM is essential to evaluate hematolymphoid lineages. Although anemia commonly occurs in nonneoplastic diseases, anemia alone should not automatically trigger FCM.

FCM may be useful in hypercellular hematolymphoid disorders to differentiate reactive conditions from neoplastic conditions. In the absence of blasts, neutrophilic leukocytosis is not generally an indication for FCM. Isolated polycythemia and basophilia are not sufficient to warrant FCM.

Lymphomas 

In the current WHO classification, all non-Hodgkin lymphomas (NHLs) are distinct clinicopathologic entities defined by their clinical features, morpholology, immunophenotype and, where appropriate, their genetic abnormalities. Immunophenotyping by FCM allows multiparameter evaluation of single cells and the ability to work on very small samples.

Most new cases of suspected NHL undergo initial immunophenotypic analysis as part of the routine handling of a specimen. A standard lymphoma panel is designed to identify abnormal populations of B cells, T cells and/or NK cells. A standard lymphoma panel might include a combination of markers from the following categories: T cells (CD2, CD3, CD4, CD5, CD7, CD8); B cells (CD19, CD20, CD23); Kappa and lambda surface immunoglobulins light chains; plasma cells (CD38 and CD138); CALLA (CD10); CD45; CD56: FMC-7, CD103, CD11b, CD13, CD14, CD15, CD16 and CD34.

The immunophenotypes of lymphomas are widely known and FCM allows appropriate classification of most cases. However, atypical patterns occur and pose significant diagnostic difficulties where aberrant antigen expression patterns must be reconciled with morphology. Additional markers may be required to characterize the abnormal population of cells including markers of immature cells (HLA-DR), B cells (CD22) and myeloid cells (CD14, CD15, CD33, CD64, CD117).

Acute Leukemia

The diagnosis and management of acute leukemia depend on the detection, identification and characterization of leukemic cells. The identification of leukemic cells is straightforward in most occasions. However, each acute leukemia subgroup has heterogeneous biologic characteristics, many of which are associated with a different response to therapy.

As part of a routine diagnostic workup, most suspected acute leukemia cases undergo initial multiparameter immunophenotypic analysis, combined with morphology, cytochemistry, cytogenetics, and molecular biology.

A standard acute leukemia FCM panel is designed to determine whether leukemic blasts are of myeloid or lymphoid origin, and then to further classify the neoplastic cells (myeloid blasts, B lymphoblasts, abnormal promyelocytes, monoblasts, etc). An acute leukemia panel might include a combination of cell markers from the following categories: stem cell lineage (CD34), immature cell lineage (HLA-DR, CD 10); T cell (CD2, CD3, CD4, CD5, CD7 and CD8); B cell (CD19, CD20); myeloid cell (CD13, CD14, CD15, CD 33, CD 64 and CD17); CD38, CD45, and CD56.

When the routine panel is insufficient to characterize the leukemic cells, additional antibodies including erythroid markers (CD71 and glycophorin A), megakaryocytic markers (CD41, CD61) or cytoplasmic markers may be indicated.

Chronic Lymphocytic Leukemia (CLL) & Other Chronic Lymphoproliferative Diseases (CLPD)

The history, physical exam (lymphadenopathy, splenomegaly and/or hepatomegaly) laboratory findings (lymphocytosis, granulocytopenia, anemia, thrombocytopenia), and lymphocyte morphology are suggestive of CLL. The diagnosis is established by paradoxical co-expression of CD5 on peripheral lymphocytes that express B cell markers (CD19, CD20, CD21 and CD 23) with Kappa or lambda immunoglobulin light chain restriction. Additional markers such as CD38 and ZAP70 may provide important prognostic information.

FCM can distinguish CLL, the peripheral counterpart of small lymphocytic lymphoma, often diagnosed in lymph node biopsies, from other indolent lymphocytic malignancies including prolymphocytic leukemia, Waldenstrom’s macroglobulinemia, leukemic phase of lymphomas, hairy cell leukemia, T-cell CLL, adult T-cell leukemia, large granulocytic leukemia and cutaneous T-cell lymphoma and natural killer (NK) disorders including KIR expression.


Plasma Cell Disorders

Plasma cell disorders are often identified through a combination of clinical, laboratory studies (urine or serum gamma globulins), morphologic, and radiologic findings. FCM immunophenotyping is useful to identify abnormal plasma cells, and the distinction between lymphoid and plasma cell neoplasms, and between reactive plasma cells and neoplastic plasma cells.

The initial FCM workup for a plasma cell disorder may include the basic lymphoma panel markers with additional markers such as CD28 and CD117.

Myelodysplastic Syndromes (MDS)

The gold standard for an MDS diagnosis is assessment of bone marrow smears for dysplastic changes. FCM may assist in MDS determination through the identification of abnormal maturing myeloid cells. An abnormal phenotype by FCM is a minimal diagnostic MDS criteria to establish a definitive diagnosis.

MDS has a definite risk and rate of progression to acute leukemia. Standard FCM leukemia panels are indicated to evaluate progression and onset of leukemia.

Chronic Myeloproliferative Disorders (CMPD)

Although genetic (Philadelphia chromosome and BCR/abl) and molecular studies (Jak 2) are the accepted cornerstone for the identification and classification of CMPDs, FCM may assist in the distinction from reactive hematopoietic proliferations and is important in the enumeration of blasts in the distinction from acute leukemia and an accelerated phase of CMPD.

CMPD also has a definite risk and rate of progression to acute leukemia. Standard FCM leukemia panels are indicated to evaluate progression and onset of leukemia.

Mast Cell Neoplasms

Mast cell neoplasms are uncommon disorders. Mast cells coexpress multiple markers including CD9, CD33, CD45, CD68, CD117, but also lack several myelomonocytic antigens including CD14, CD15, CD16 and most T- and B- cells antigens. Neoplastic mast cells have a similar antigen profile, but also can coexpress CD2 and CD25, which helps in distinguishing malignant mast cells from mastocytosis.

Paroxysmal hemoglobinuria (PNH)

PNH is a rare clonal hematopoietic disorder of stem cells. This condition is caused by genetic mutation that results in the absence of over a dozen surface antigens on red and white blood cells. FCM can diagnose PNH by assessing both the red and white blood cells for the absence of these antigens.

Minimal Residual Disease (MRD)

FCM analysis for MRD must identify phenotypic features characteristic of the disease of interest. The MRD flow analysis should not rely on an exact match between the phenotype of the residual disease and the original diagnostic specimen because phenotypes can change over time and with treatment. The antibody combinations should be chosen to maximize detection of disease, limit the impact of phenotypic variation, and permit detection of disease following antibody directed therapy.

HIV Infection

HIV-1 infection causes significant changes in the number of CD4 and CD8 positive lymphocytes. CD4 count falls roughly 30% while CD8 count increases within 6 months after seroconversion, causing a decrease in the CD4/CD8 ratio

Following HIV-1 diagnosis, FCM should include enumeration of mature T cells (CD3), helper T cells (CD4) and suppressor T cells (CD8) to ensure all major T cell subsets are accounted for (the sum of helper CD4 and suppressor CD8 T cells is roughly close to the total number of CD3 positive T cells). This ensures that the absolute CD4 is not artificially decreased due to sample degradation or other artifact.

A WBC count with differential also needs to be performed to calculate the absolute CD4 count (absolute lymphocyte count times CD4%).

Organ Transplants

In order to differentiate early rejection, immunosuppressive therapy toxicity or infection, FCM may be indicated to monitor postoperative organ transplants. CD3 is useful to monitor the effectiveness of certain immunosuppressive therapies. When the transplant patient demonstrates symptoms for the above conditions, repeated analysis may be required.

DNA Analysis

Carcinoma, Non-hematolymphoid Tumors
DNA analysis of tumor for ploidy and percent S-phase cells may be necessary for a few selective patients with carcinomas. When the obtained prognostic information will affect treatment decisions in patients with low stage (localized) disease, FCM results are useful.

Molar Pregnancy

FCM is useful to evaluate molar and partial molar pregnancies. Using a method to quantify DNA, similar to that used for evaluation of carcinomas, partial moles (triploid), can be distinguished from normal placenta and complete molar (diploid) pregnancies.

Primary Immunodeficiencies(PIDS)

PIDs are rare disorders that reflect inherited abnormalities in the development and maturation of cells responsible for immune function. More than 120 inherited immunodeficiency disorders are currently recognized. Affected individuals are prone to repeated infections, allergies, autoimmune disorders, and malignancies. Diagnosis typically occurs at an early age.

FCM may be indicated for diagnostic purposes and is usually limited to T (CD3, CD4, CD8), B (CD20) and NK cell (CD56) markers. Additional disease specific markers may be indicated.

Primary Platelet Disorders, Non-neoplastic

FCM is used for platelet analysis in quantitative and qualitative disorders such as Glanzmann Thrombasthenia (GT) and Bernard-Soulier Disease (B-S). GT is a rare inherited or acquired platelet disorder. Hereditary GT is defined by platelets with decreased expression or absence of the GPIIa/GPIIIb receptor. This receptor is responsible for the initial platelet plug at the site of endothelial injury. Absence if the receptor may result in increased bleeding.

Acquired GT is likely an autoimmune phenomenon with the presence of GPIIb/GPIIIa blocking antibodies. FCM may be used to determine the functional effect and identity the molecular targets of these antibodies.

B-S is another rare inherited disorder that prevents the initial binding of platelets at the site of endothelial injury by absence of or presence of abnormal surface GPIa/V/IX receptor. Abnormalities of this receptor prevent attachment of platelets to subendothelial or free von Willebrand’s factor with subsequent tendency to bleed.

FCM may be used to measure antibodies directed at specific loci of the GPIa/V/IX receptor, which include GPIb (CD42b), GPIX (CD42a), and GPV (CD42d). FCM is also used to assess the size of platelets in the initial evaluation of B-S disease. In B-S disease, platelets are generally larger than normal. FCM can distinguish B-S platelets from fragmented RBCs and debris by antibodies directed to the GPIb/IX/V receptor.

Red Cell and White Cell Disorders, Non-neoplastic

FCM is a valuable tool to establish abnormal or defective red blood cell, leukocyte and lymphocyte surface receptors, transmembrane molecules, and intracellular DNA.
It may be used in acquired and congenital red cell conditions such as in quantifying fetomaternal hemorrhage and hereditary spherocytosis, hereditary elliptocytosis, and hereditary persistence of fetal hemoglobin in the context of compound hemoglobinopathy syndromes.

FCM is a sensitive and specific method to identify leukocyte receptor abnormalities for the diagnosis of chronic granulomatous disease and CD11b deficiency.
It is an efficient method to identify lymphocytes HLA B27 associated with uveitis, ankylosing spondylitis, Reiter’s syndrome and sacroiliitis.

Limitations:

Since FCM immunophenotypes for most common lymphomas and leukemias are well characterized, Noridian does NOT consider it “reasonable and necessary” to perform more than 24 markers in a panel. When atypical or unusual FCM results are obtained, the selective addition of more markers may be indicated.

The flow report must document the specific indication for each marker over the 24 marker limit.

The FCM report must document the specific indication for each marker over the 24-marker limit. FCM reports without clear justification for each marker over 24 will be denied.


Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
012xHospital Inpatient (Medicare Part B only)
013xHospital Outpatient
014xHospital - Laboratory Services Provided to Non-patients
018xHospital - Swing Beds
021xSkilled Nursing - Inpatient (Including Medicare Part A)
022xSkilled Nursing - Inpatient (Medicare Part B only)
023xSkilled Nursing - Outpatient
071xClinic - Rural Health
077xClinic - Federally Qualified Health Center (FQHC)
085xCritical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0300Laboratory - General Classification
0302Laboratory - Immunology
0309Laboratory - Other Laboratory



Group 2 Paragraph: Quantitative Codes in immunology section:


Group 2 Codes:

86355B cells total count
86356Mononuclear cell antigen
86357Nk cells total count
86359T cells total count
86360T cell absolute count/ratio
86361T cell absolute count
86367Stem cells total count



ICD-10 Codes that Support Medical Necessity


ICD-10 CODEDESCRIPTION

A18.01Tuberculosis of spine
B20Human immunodeficiency virus [HIV] disease
B97.33Human T-cell lymphotrophic virus, type I [HTLV-I] as the cause of diseases classified elsewhere
B97.34Human T-cell lymphotrophic virus, type II [HTLV-II] as the cause of diseases classified elsewhere
B97.35Human immunodeficiency virus, type 2 [HIV 2] as the cause of diseases classified elsewhere
C15.3Malignant neoplasm of upper third of esophagus
C15.4Malignant neoplasm of middle third of esophagus
C15.5Malignant neoplasm of lower third of esophagus
C15.8Malignant neoplasm of overlapping sites of esophagus
C16.0Malignant neoplasm of cardia
C16.1Malignant neoplasm of fundus of stomach
C16.2Malignant neoplasm of body of stomach
C16.3Malignant neoplasm of pyloric antrum
C16.4Malignant neoplasm of pylorus
C16.8Malignant neoplasm of overlapping sites of stomach
C17.0Malignant neoplasm of duodenum
C17.1Malignant neoplasm of jejunum
C17.2Malignant neoplasm of ileum
C17.8Malignant neoplasm of overlapping sites of small intestine
C18.0Malignant neoplasm of cecum
C18.1Malignant neoplasm of appendix
C18.2Malignant neoplasm of ascending colon
C18.3Malignant neoplasm of hepatic flexure
C18.4Malignant neoplasm of transverse colon
C18.5Malignant neoplasm of splenic flexure
C18.6Malignant neoplasm of descending colon
C18.7Malignant neoplasm of sigmoid colon
C18.8Malignant neoplasm of overlapping sites of colon
C19Malignant neoplasm of rectosigmoid junction
C20Malignant neoplasm of rectum
C21.1Malignant neoplasm of anal canal
C21.2Malignant neoplasm of cloacogenic zone
C21.8Malignant neoplasm of overlapping sites of rectum, anus and anal canal
C22.0Liver cell carcinoma
C22.2Hepatoblastoma
C22.3Angiosarcoma of liver
C22.4Other sarcomas of liver
C22.7Other specified carcinomas of liver
C22.9Malignant neoplasm of liver, not specified as primary or secondary
C23Malignant neoplasm of gallbladder
C24.0Malignant neoplasm of extrahepatic bile duct
C24.1Malignant neoplasm of ampulla of Vater
C25.0Malignant neoplasm of head of pancreas
C25.1Malignant neoplasm of body of pancreas
C25.2Malignant neoplasm of tail of pancreas
C25.7Malignant neoplasm of other parts of pancreas
C25.8Malignant neoplasm of overlapping sites of pancreas
C26.1Malignant neoplasm of spleen
C26.9Malignant neoplasm of ill-defined sites within the digestive system
C30.0Malignant neoplasm of nasal cavity
C30.1Malignant neoplasm of middle ear
C31.0Malignant neoplasm of maxillary sinus
C31.1Malignant neoplasm of ethmoidal sinus
C31.2Malignant neoplasm of frontal sinus
C31.3Malignant neoplasm of sphenoid sinus
C31.8Malignant neoplasm of overlapping sites of accessory sinuses
C32.0Malignant neoplasm of glottis
C32.1Malignant neoplasm of supraglottis
C32.2Malignant neoplasm of subglottis
C32.3Malignant neoplasm of laryngeal cartilage
C32.8Malignant neoplasm of overlapping sites of larynx
C33Malignant neoplasm of trachea
C34.01Malignant neoplasm of right main bronchus
C34.02Malignant neoplasm of left main bronchus
C34.11Malignant neoplasm of upper lobe, right bronchus or lung
C34.12Malignant neoplasm of upper lobe, left bronchus or lung
C34.2Malignant neoplasm of middle lobe, bronchus or lung
C34.31Malignant neoplasm of lower lobe, right bronchus or lung
C34.32Malignant neoplasm of lower lobe, left bronchus or lung
C34.81Malignant neoplasm of overlapping sites of right bronchus and lung
C34.82Malignant neoplasm of overlapping sites of left bronchus and lung
C37Malignant neoplasm of thymus
C38.1Malignant neoplasm of anterior mediastinum
C38.2Malignant neoplasm of posterior mediastinum
C38.4Malignant neoplasm of pleura
C38.8Malignant neoplasm of overlapping sites of heart, mediastinum and pleura
C40.01Malignant neoplasm of scapula and long bones of right upper limb
C40.02Malignant neoplasm of scapula and long bones of left upper limb
C40.11Malignant neoplasm of short bones of right upper limb
C40.12Malignant neoplasm of short bones of left upper limb
C40.21Malignant neoplasm of long bones of right lower limb
C40.22Malignant neoplasm of long bones of left lower limb
C40.31Malignant neoplasm of short bones of right lower limb
C40.32Malignant neoplasm of short bones of left lower limb
C40.81Malignant neoplasm of overlapping sites of bone and articular cartilage of right limb
C40.82Malignant neoplasm of overlapping sites of bone and articular cartilage of left limb
C41.0Malignant neoplasm of bones of skull and face
C41.2Malignant neoplasm of vertebral column
C41.3Malignant neoplasm of ribs, sternum and clavicle
C41.4Malignant neoplasm of pelvic bones, sacrum and coccyx
C44.01Basal cell carcinoma of skin of lip
C44.02Squamous cell carcinoma of skin of lip
C44.09Other specified malignant neoplasm of skin of lip
C44.112Basal cell carcinoma of skin of right eyelid, including canthus
C44.119Basal cell carcinoma of skin of left eyelid, including canthus
C44.122Squamous cell carcinoma of skin of right eyelid, including canthus
C44.129Squamous cell carcinoma of skin of left eyelid, including canthus
C44.192Other specified malignant neoplasm of skin of right eyelid, including canthus
C44.199Other specified malignant neoplasm of skin of left eyelid, including canthus
C44.212Basal cell carcinoma of skin of right ear and external auricular canal

Procedure codes and Description

J1459INJECTION, IMMUNE GLOBULIN (PRIVIGEN), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG

J1556INJECTION, IMMUNE GLOBULIN (BIVIGAM), 500 MG

J1557INJECTION, IMMUNE GLOBULIN, (GAMMAPLEX), INTRAVENOUS, NON-
LYOPHILIZED (E.G., LIQUID), 500 MG

J1561INJECTION, IMMUNE GLOBULIN, (GAMUNEX-C/GAMMAKED), NON-LYOPHILIZED (E.G., LIQUID), 500 MG

J1566INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, LYOPHILIZED (E.G., POWDER), NOT OTHERWISE SPECIFIED, 500 MG

J1568INJECTION, IMMUNE GLOBULIN, (OCTAGAM), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG

J1569INJECTION, IMMUNE GLOBULIN, (GAMMAGARD LIQUID), NON-LYOPHILIZED, (E.G., LIQUID), 500 MG

J1572INJECTION, IMMUNE GLOBULIN, (FLEBOGAMMA/FLEBOGAMMA DIF), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG

J1599INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), NOT OTHERWISE SPECIFIED, 500 MG



Coverage Indications, Limitations, and/or Medical Necessity

Note: Providers should seek information related to National Coverage Determinations (NCD) and other Centers for Medicare & Medicaid Services (CMS) instructions in CMS Manuals. This LCD only pertains to the contractor's discretionary coverage related to this drug.

IVIg is a solution of human immunoglobulins specifically prepared for intravenous infusion. Immunoglobulin contains a broad range of antibodies that specifically act against bacterial and viral antigens.

There may be acceptable off-label uses for IVIg in rare patient populations or in rare individual patient clinical scenarios which are not covered by this LCD. In such instances, a request for an individual patient consideration by the Medical Director should accompany the appeal of any denied claim.

There are several off-label uses for IVIg, especially in neurological disorders. There is good scientific evidence that supports use in a few of the disorders; in others, however, the evidence is either poor or absent. This policy addresses the off-label uses of IVIg in certain neurological conditions, and idiopathic thrombocytopenic purpura (ITP) in pregnancy. It also clarifies the conditions under which certain FDA-approved uses may be covered. This policy does not address the use of IVIg in any condition covered by a National Coverage Determination (NCD) or CMS manual instruction. (See attached article)

Idiopathic Thrombocytopenic Purpura (ITP) in Pregnancy:

Pregnant women with this disease are at risk for delivering thrombocytopenic infants. Protection of the fetus becomes an important consideration in management of a pregnant woman with immune thrombocytopenic purpura. IVIg may be recommended in the following:

1. Pregnant women who have previously delivered infants with autoimmune thrombocytopenia;
2. Pregnant women who have platelet counts less than 75,000/mm3 during the current pregnancy; or
3. Pregnant women with past history of splenectomy


In the presence of one of the above indications, the use of IVIg may be covered if one of the following situations is present:

•Failure of or contraindications to other therapy; and/or

•Rapidly progressive form of the disease;

All the conditions listed below (see Neurological Disorders) for Medicare coverage are met.

Neurological Disorders:
The use of IVIg in some neurological conditions has been associated with demonstrable clinical benefit. Studies with acceptable methodological bases have shown that IVIg may halt and/or reverse disease progression in Myasthenia Gravis, Guillain-Barre Syndrome and Chronic Inflammatory Demyelinating Neuropathy (CIDP). In a few neurological conditions, such as Polymyositis, Multiple Myeloma, Multifocal Motor Neuropathy (MMN), Dermatomyositis and Lambert-Eaton myasthenic syndrome, IVIg may be of benefit.

Medicare may provide coverage for the use of IVIg use in the above disease conditions if the following requirements are met.

For Guillain-Barre, Myasthenia Gravis, Acute or Chronic Inflammatory Demyelinating Neuropathy (see CIDP below for additional criteria), Dermatomyositis, and Relapsing-Remitting Multiple Sclerosis (MS), the use of IVIg may be covered if one of the following scenarios is present:

•Failure of or contraindications to other therapy (absolute requirement for Dermatomyositis and MS); and/or

•Rapidly progressive form of the disease.


The diagnosis of the disorder must be reasonably certain, based on a thorough history and examination as well as, when necessary, electromyography (EMG), spinal fluid tests, serum tests and biopsy findings.

The clinical record must document the medical necessity to initiate IVIg therapy, and the ongoing need as long as treatment continues. The reasons for prescribing IVIg must be clear and include all required information. For example, previous treatment failures must be recorded.

Once treatment is initiated, documentation of progress must be meticulous. If there is initial improvement and continued treatment is necessary, then some type of quantitative assessment to monitor and document the progress is required. Quantitative monitoring may include any accepted metric assessment such as MRC scale and activities of daily living (ADL) measurements. Changes in these measures must be clearly documented. Subjective or experiential improvement alone is insufficient to either continue IVIg or to expect coverage.

Clinical monitoring takes precedence over laboratory monitoring. If significant clinical improvement is evident, then laboratory monitoring, solely to guide IVIg therapy, is not medically necessary.

When improvement has occurred, attempts to decrease/wean the dosage must be made and documented. Following dosage reduction, if improvement is sustained, an attempt to discontinue IVIg must be made. If documentable improvement does not occur with IVIg administration, then infusions should not continue.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and its variants (multifocal motor neuropathy, multifocal acquired demyelinating polyneuropathy, multifocal motor neuropathy, pure sensory CIDP).

CIDP is an autoimmune disorder caused by an attack on peripheral nervous system myelin. Clinically CIDP follows a subacute onset of weakness and/or sensory loss, evolving progressively, or in a stepwise fashion, over several months. Reflexes are usually decreased or absent. Electrodiagnostic testing (EDX) reveals the classic features of demyelination, with prolonged distal latencies, conduction slowing, prolonged F-waves, conduction block, and temporal dispersion in most cases. Most patients have an elevated spinal fluid protein level. (Jonathan S. Katz, MD, Dept. of Neurology, Stanford University)

Chronic progressive painful peripheral sensory neuropathy, which is common with diabetes mellitus or toxins, may eventually show demyelinating features on electrodiagnostic testing. Typically, these cases have progressed for more than one year prior to electrodiagnostic testing. Many patients with CIDP are not seen until several years into their illness.

In patients with sensory or sensorimotor polyneuropathies, when a CIDP diagnosis is uncertain, a response to a therapeutic trial of prednisone (e.g. 30-60 mg/d or perhaps 50-100 mg/d for 2-4 months with a taper) should be helpful to increase the specificity of the diagnosis in order to help assure that IVIg will be effective. In the absence of other supporting information, a subjective response to a therapeutic trial of IVIg is not sufficient to validate the diagnosis of CIDP. The principal goal of the treatment is to improve motor function in most patients.

If a diagnosis of multifocal motor neuropathy is suspected, a trial of IVIg is recommended since this condition does not respond to prednisone.

Specific diagnostic criteria for CIDP should include:

•In typical CIDP, symmetrical muscle weakness affects proximal and distal muscles of all four limbs. Sensory loss may affect the distal limbs and usually involves large fiber modalities. The clinical evolution tends to be gradually progressive, evolving over periods of more than 8 weeks although patients typically present to clinicians within 6 months of onset. Decreased or absent reflexes in affected nerve distributions occur in nearly all CIDP presentations, and develop during the acute phase typically within 8 weeks of symptom onset. The patient should have a neurologic function assessment score of at least 3 or greater on the Rankin Scale at the time of initial therapy. However, IVIg can be used in patients with rapidly worsening weakness regardless of the Rankin score.

•A multifocal variant of CIDP (multifocal acquired demyelinating sensory and motor neuropathy or MADSAM) leads to sensory and motor dysfunction in multiple individual nerve distributions (for example, ulnar or median). Weakness may affect the upper or lower limbs, but it most commonly affects distal musculature and is more common in the hands. Progression tends to be step-wise with episodes of weakness compiling over time to cause gradually increasing debility.

•Multifocal motor neuropathy (MMN) is a purely motor syndrome that tends to affect the hands. Like MADSAM, the weakness affects the distribution of individual nerves and tends to progress in a step-wise fashion over time. Patients may have subjective sensory complaints but objective sensory findings are not present. The diagnosis is generally made using motor and sensory nerve conduction studies. MMN responds to IVIg but not to Prednisone. Therefore, Prednisone is never indicated in this condition.

•Occasionally, a patient with CIDP may have only sensory symptoms. The sensory loss may affect the upper or lower limbs and tends to be relatively symmetrical. Like more common sensory-motor CIDP presentations, patients typically seek medical attention within 6-9 months from onset. The sensory loss may begin relatively acutely and progresses in a stepwise or gradual fashion. The sensory distribution is usually not simply limited to the feet or in a stocking distribution, but takes on unusual patterns involving the trunk, arms, or proximal legs. The condition is rare compared with the relatively common purely sensory neuropathies such as distal diabetic, toxic, alcoholic, and idiopathic neuropathies. Pure sensory CIDP also must be distinguished from distal demyelinating neuropathies associated with an IgM paraprotein, which is not responsive to IVIg or prednisone.

•Laboratory evidence of CIDP includes:


oConduction block at sites not prone to nerve compression.

oMotor nerves characteristically show segmental conduction slowing and increased distal latencies consistent with a demyelinating polyneuropathy. This is present in typical CIDP, MADSAM, MMN, and purely sensory CIDP.

oConduction slowing from a demyelinating neuropathy should be distinguished from conduction slowing secondary to moderate to severe axonal loss.

oCytoalbuminologic dissociation in more than 90% of cases.

•Serum tests may show:

oAn IgG monoclonal gammopathy (e.g. on immunofixation electrophoresis); however, an IgM monoclonal gammopathy places the diagnosis in question.

oAn elevation of a specific antibody to GM-1 increases the likelihood of MMN. Antibodies to myelin associated glycoprotein (MAG) or sulfatide may occur in patients with demyelinating neuropathies besides CIDP and place the diagnosis in question.

•No other explanation for the diagnosis, such as

oHIV disease;

oDistally predominant diabetic neuropathy;

oDiabetic amyotrophy;

oDiabetic cachectic neuropathy;

oDistal acquired demyelinating symmetric neuropathy with an IgM paraprotein; or

•No evidence of another treatable cause of the polyneuropathy;

•No evidence of hereditary demyelinating neuropathy.

Special consultation recommendations for IVIg use for CIDP, CIDP variants, and MMN:

•Before beginning the initial treatment (i.e. the induction dose) for CIDP, or, for patients currently on treatment for CIDP within 3 months of the effective date of this policy, a consultation is expected from a neurologist or rheumatologist who is an expert in the field of CIDP. This will help validate the diagnosis is correct and the IVIg treatment is reasonable and necessary. The consultation should include a comprehensive history and examination as defined in the CPT book, validate the diagnosis of CIDP, and clarify the need for IVIg treatment. The consultation should set forth the recommended treatment regimen, appropriate measures of therapeutic benefit, and any recommendation for follow-up consultation.

•If the indication for IVIg treatment is principally for pain control in a patient with presumed CIDP predominantly affecting the sensory nerves, before beginning the initial treatment (i.e. the induction dose), the patient should have shown a measurable response to a therapeutic trial of prednisone. In addition, the consultation from a neurologist or rheumatologist who is an expert in the field of CIDP is expected. This consultation should help validate the need for IVIg treatment for pain control as opposed to other pain treatment options that do not include IVIg.

IVIg for CIDP following the initial treatment regimen:

•Once treatment is initiated, the benefit of treatment must be measured. Quantitative monitoring may use any accepted metric as MRC scale and activities of daily living (ADL) measurements.

•Subsequent treatment with IVIg will be covered only when the patient demonstrates significant improvement in clinical condition and, when relevant, a reduction in the level of sensory loss. For long-term treatment of stable patients, the dose must be periodically reduced or withdrawn, and the effects measured, in order to validate continued use.

There is no reimbursement for the use of IVIg in the treatment of the following neurological disorders: epilepsy, Amyotrophic Lateral Sclerosis (ALS), paraneoplastic neurological syndromes, undiagnosed neuropathy or weakness and malignancies with no casual link to coexisting neurological dysfunctions.

The use of IVIg should be reserved for patients with serious defects of antibody function. The goal is to provide immune globulin to those who lack it. The following are certain FDA approved indications for IVIg, which are covered by Noridian.

Acute ITP:

•Management of acute bleeding due to severe thrombocytopenia (platelet counts less than 30,000/mm3);

•To increase platelet counts prior to invasive major surgical procedures (splenectomy); or

•In patients with severe thrombocytopenia (platelet counts less than 20,000/mm3) considered to be at risk for intracerebral hemorrhage.


Chronic Refractory ITP:

First line treatment

oPediatric ITP;
oIn combination with steroids if rapid platelet response justified or to avoid splenectomy; or
oContraindications to steroids

Second line treatment

oFollowing treatment with corticosteroids with splenectomy; or
oPlatelet counts persistently at or below 20,000/mm 3.

Symptomatic Human Immunodeficiency Virus (HIV):

Indications for intravenous immunoglobulin would include:

1. Patients less than 13 years of age;
2. Entry CD4+ lymphocyte counts greater than or equal to 200/mm3; and
3. Clinically symptomatic or asymptomatic, but immunologically abnormal

Other Disorders:

a. Chronic Lymphocytic Leukemia with associated hypogammaglobulinemia. To initiate IVIg for this disease, the IgG level should be less than 600 mg/dl or there should be evidence of specific antibody deficiency and the presence of repeated bacterial infections.
b. Bone Marrow/Stem Cell Transplantation

oTransplantation must have been for a Medicare covered indication;

oPatients 20 years of age or older;

oCytomegalovirus (CMV) seropositive before transplantation; or

oCytomegalovirus (CMV) seronegative, had seropositive marrow donors, and were undergoing allogenic transplantation for hematologic neoplasms.

c. Kawasaki Disease (Mucocutaneous Lymph Node Syndrome)
d. Transplantation rejection, kidney or stem cell, antibody-mediated.
e. Autoimmune retinopathy (limited to three months unless there is improvement on therapy).

Immunoglobulin Deficiencies:
Individuals with agammaglobulinemia or hypogammaglobulin need lifelong antibody replacement, however, Ig replacement is unlikely to be necessary until the IgG levels fall below 200 mg/dl.


Bill Type Codes:
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
012xHospital Inpatient (Medicare Part B only)
013xHospital Outpatient
022xSkilled Nursing - Inpatient (Medicare Part B only)
023xSkilled Nursing - Outpatient
085xCritical Access Hospital

Revenue Codes:
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
The Section titled “Does the 'CPT 30% Rule' Apply?” needs clarification. This rule comes from the AMA (American Medical Association), the organization that holds the copyrights for all CPT codes. The rule states that if, in a given section (e.g., surgery) or subsection (e.g., surgery, integumentary) of CPT Manual, more than 30% of the codes are listed in the LCD, then the short descriptors must be used rather than the long descriptors found in the CPT Manual.
0636Pharmacy - Drugs Requiring Detailed Coding





ICD-10 Codes that Support Medical Necessity


Group 1Codes

ICD-10 CODEDESCRIPTION
B20*Human immunodeficiency virus [HIV] disease
B25.0Cytomegaloviral pneumonitis
B25.1Cytomegaloviral hepatitis
B25.2Cytomegaloviral pancreatitis
B25.8Other cytomegaloviral diseases
C90.00Multiple myeloma not having achieved remission
C90.02Multiple myeloma in relapse
C91.10Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11Chronic lymphocytic leukemia of B-cell type in remission
C91.12Chronic lymphocytic leukemia of B-cell type in relapse
D59.0Drug-induced autoimmune hemolytic anemia
D59.1Other autoimmune hemolytic anemias
D61.01*Constitutional (pure) red blood cell aplasia
D69.3Immune thrombocytopenic purpura
D69.42Congenital and hereditary thrombocytopenia purpura
D69.49Other primary thrombocytopenia
D80.0Hereditary hypogammaglobulinemia
D80.1Nonfamilial hypogammaglobulinemia
D80.5Immunodeficiency with increased immunoglobulin M [IgM]
D81.0Severe combined immunodeficiency [SCID] with reticular dysgenesis
D81.1Severe combined immunodeficiency [SCID] with low T- and B-cell numbers
D81.2Severe combined immunodeficiency [SCID] with low or normal B-cell numbers
D81.6Major histocompatibility complex class I deficiency
D81.7Major histocompatibility complex class II deficiency
D81.89Other combined immunodeficiencies
D81.9Combined immunodeficiency, unspecified
D82.0Wiskott-Aldrich syndrome
D83.0Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function
D83.2Common variable immunodeficiency with autoantibodies to B- or T-cells
D83.8Other common variable immunodeficiencies
D83.9Common variable immunodeficiency, unspecified
G25.82Stiff-man syndrome
G35Multiple sclerosis
G60.3Idiopathic progressive neuropathy
G61.0Guillain-Barre syndrome
G61.81*Chronic inflammatory demyelinating polyneuritis
G61.82Multifocal motor neuropathy
G65.0Sequelae of Guillain-Barre syndrome
G70.00Myasthenia gravis without (acute) exacerbation
G70.01Myasthenia gravis with (acute) exacerbation
G70.81Lambert-Eaton syndrome in disease classified elsewhere
G73.1Lambert-Eaton syndrome in neoplastic disease
G73.3Myasthenic syndromes in other diseases classified elsewhere
M30.3Mucocutaneous lymph node syndrome [Kawasaki]
M31.1Thrombotic microangiopathy
M33.00Juvenile dermatopolymyositis, organ involvement unspecified
M33.01Juvenile dermatopolymyositis with respiratory involvement
M33.02Juvenile dermatopolymyositis with myopathy
M33.09Juvenile dermatopolymyositis with other organ involvement
M33.10Other dermatopolymyositis, organ involvement unspecified
M33.11Other dermatopolymyositis with respiratory involvement
M33.12Other dermatopolymyositis with myopathy
M33.19Other dermatopolymyositis with other organ involvement
M33.20Polymyositis, organ involvement unspecified
M33.21Polymyositis with respiratory involvement
M33.22Polymyositis with myopathy
M33.29Polymyositis with other organ involvement
M33.90Dermatopolymyositis, unspecified, organ involvement unspecified
M33.91Dermatopolymyositis, unspecified with respiratory involvement
M33.92Dermatopolymyositis, unspecified with myopathy
M33.99Dermatopolymyositis, unspecified with other organ involvement
M34.83Systemic sclerosis with polyneuropathy
M36.0Dermato(poly)myositis in neoplastic disease
T86.01Bone marrow transplant rejection
T86.02Bone marrow transplant failure
T86.09Other complications of bone marrow transplant
T86.11Kidney transplant rejection
T86.12Kidney transplant failure
T86.19Other complication of kidney transplant
T86.5Complications of stem cell transplant
Z48.22Encounter for aftercare following kidney transplant
Z94.0Kidney transplant status
Z94.81Bone marrow transplant status
Z94.84Stem cells transplant status
Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: *B20 is only payable for children under 13 years of age.
*D61.01 is only to be used when patient has failed all first line therapies.
*G61.81 is not payable when associated with diabetes mellitus, dysproteinemias, renal failure, or malnutrition.
Showing 1 to 74 of 74 entries in Group 1
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ICD-10 Codes that DO NOT Support Medical Necessity

Group 1 Paragraph: Any diagnosis codes other than those listed in the covered ICD-10-CM codes of this policy and those in the attached article will be denied as not reasonable and necessary and will be denied provider liable unless a non-coverage notice has been issued to the beneficiary prior to the test. Screening diagnoses will be denied as routine services.

Group 1 Codes: N/A




Additional ICD-10 Information
N/A

Procedure Codes and Description

Group 1 Paragraph: Italicized and/or quoted material is excerpted from the American Medical Association, Current Procedural (CPT) codes.

Group 1 Codes:
82306VITAMIN D; 25 HYDROXY, INCLUDES FRACTION(S), IF PERFORMED
82652VITAMIN D; 1, 25 DIHYDROXY, INCLUDES FRACTION(S), IF PERFORMED

Coverage Indications, Limitations, and/or Medical Necessity

Vitamin D is called a "vitamin" because of its exogenous source, predominately from oily fish in the form of vitamin D 2 and vitamin D 3. It is more accurate to consider fat-soluble Vitamin D as a steroid hormone, synthesized by the skin and metabolized by the kidney to an active hormone, calcitriol. Clinical disorders related to vitamin D may arise because of altered availability of the parent vitamin D, altered conversion of vitamin D to its predominant metabolites, altered organ responsiveness to dihydroxylated metabolites and disturbances in the interactions of the vitamin D metabolites with PTH and calcitonin. Normal levels of Vitamin D range from 20 – 50 ng/dl. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for the lab assay.

Indications:

Measurement of 25-OH Vitamin D, CPT 82306, level is indicated for patients with:

chronic kidney disease stage III or greater

cirrhosis

hypocalcemia

hypercalcemia

hypercalciuria

hypervitaminosis D

parathyroid disorders

malabsorption states

obstructive jaundice

osteomalacia

osteoporosis if
i. T score on DEXA scan ii. History of fragility fractures or
iii. FRAX > 3% 10-year probability of hip fracture or 20% 10-year probability of other major osteoporotic fracture or
iv. FRAX > 3% (any fracture) with T-score v. Initiating bisphosphanate therapy (Vit D level should be determined and managed as necessary before bisphosphonate is initiated)

osteosclerosis/petrosis

rickets

vitamin D deficiency on replacement therapy related to a condition listed above; to monitor the efficacy of treatment.

Measurement of 1, 25-OH Vitamin D, CPT 82652, level is indicated for patients with:

unexplained hypercalcemia (suspected granulomatous disease or lymphoma)

unexplained hypercalciuria (suspected granulomatous disease or lymphoma)

suspected genetic childhood rickets

suspected tumor-induced osteomalacia

nephrolithiasis or hypercalciuria

Limitations:

Testing may not be used for routine or other screening.

Both assays of vitamin D need not be performed for each of the above conditions. Often, one type is more appropriate for a certain disease state than another. The most common type of vitamin D deficiency is 25-OH vitamin D. A much smaller percentage of 1,25 dihydroxy vitamin D deficiency exists; mostly, in those with renal disease. Documentation must justify the test(s) chosen for a particular disease entity. Various component sources of 25-OH vitamin D, such as stored D or diet-derived D, should not be billed separately.

Once a beneficiary has been shown to be vitamin D deficient, further testing may be medically necessary only to ensure adequate replacement has been accomplished. If Vitamin D level is between 20 and 50 ng/dl and patient is clinically stable, repeat testing is often unnecessary; if performed, documentation most clearly indicate the necessity of the test. If level 60 ng/dl, a subsequent level(s) may be reimbursed until the level is within the normal range.20>


Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
012xHospital Inpatient (Medicare Part B only)
013xHospital Outpatient
014xHospital - Laboratory Services Provided to Non-patients
018xHospital - Swing Beds
022xSkilled Nursing - Inpatient (Medicare Part B only)
023xSkilled Nursing - Outpatient
085xCritical Access Hospital

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0300Laboratory - General Classification
0301Laboratory - Chemistry
0309Laboratory - Other Laboratory





ICD-10 Codes that Support Medical Necessity


ICD-10 CODEDESCRIPTION

E20.0Idiopathic hypoparathyroidism
E20.8Other hypoparathyroidism
E20.9Hypoparathyroidism, unspecified
E21.0Primary hyperparathyroidism
E21.1Secondary hyperparathyroidism, not elsewhere classified
E21.2Other hyperparathyroidism
E21.3Hyperparathyroidism, unspecified
E41Nutritional marasmus
E43Unspecified severe protein-calorie malnutrition
E55.0Rickets, active
E55.9*Vitamin D deficiency, unspecified
E67.3Hypervitaminosis D
E83.30Disorder of phosphorus metabolism, unspecified
E83.31Familial hypophosphatemia
E83.32Hereditary vitamin D-dependent rickets (type 1) (type 2)
E83.39Other disorders of phosphorus metabolism
E83.50*Unspecified disorder of calcium metabolism
E83.51Hypocalcemia
E83.52Hypercalcemia
E89.2Postprocedural hypoparathyroidism
E89.820Postprocedural hematoma of an endocrine system organ or structure following an endocrine system procedure
E89.821Postprocedural hematoma of an endocrine system organ or structure following other procedure
E89.822Postprocedural seroma of an endocrine system organ or structure following an endocrine system procedure
E89.823Postprocedural seroma of an endocrine system organ or structure following other procedure
K74.1Hepatic sclerosis
K74.2Hepatic fibrosis with hepatic sclerosis
K76.9Liver disease, unspecified
K90.0Celiac disease
K90.1Tropical sprue
K90.2Blind loop syndrome, not elsewhere classified
K90.3Pancreatic steatorrhea
K90.41Non-celiac gluten sensitivity
K90.49Malabsorption due to intolerance, not elsewhere classified
K90.89Other intestinal malabsorption
K90.9Intestinal malabsorption, unspecified
K91.2Postsurgical malabsorption, not elsewhere classified
M81.0Age-related osteoporosis without current pathological fracture
M81.8Other osteoporosis without current pathological fracture
M83.0Puerperal osteomalacia
M83.1Senile osteomalacia
M83.2Adult osteomalacia due to malabsorption
M83.3Adult osteomalacia due to malnutrition
M83.4Aluminum bone disease
M83.5Other drug-induced osteomalacia in adults
M83.8Other adult osteomalacia
M83.9Adult osteomalacia, unspecified
M85.80Other specified disorders of bone density and structure, unspecified site
M85.88Other specified disorders of bone density and structure, other site
N18.3Chronic kidney disease, stage 3 (moderate)
N18.4Chronic kidney disease, stage 4 (severe)
N18.5Chronic kidney disease, stage 5
N18.6End stage renal disease
N25.81Secondary hyperparathyroidism of renal origin
Q78.2Osteopetrosis
Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: E55.9* If more than one LCD-listed condition contributes to Vit. D deficiency in a given patient and/or is improved by Vit. D administration, coders should use: ICD-10 E55.9 UNSPECIFIED VITAMIN D DEFICIENCY.This code should not be used for any other indication.

E83.50* Use only for HYPERCALCIURIA
t

Group 2 Paragraph: The following ICD-10-CM codes support the medical necessity of CPT code 82652

Group 2 Codes:
Show entries for Group 2 ICD-10 Codes that Support Medical Necessity:
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Group 2Codes

ICD-10 CODEDESCRIPTION
E55.0Rickets, active
E55.9Vitamin D deficiency, unspecified
E83.50*Unspecified disorder of calcium metabolism
E83.52*Hypercalcemia
M83.0Puerperal osteomalacia
M83.1Senile osteomalacia
M83.2Adult osteomalacia due to malabsorption
M83.3Adult osteomalacia due to malnutrition
M83.4Aluminum bone disease
M83.5Other drug-induced osteomalacia in adults
M83.8Other adult osteomalacia
M83.9Adult osteomalacia, unspecified
N20.0Calculus of kidney
N20.1Calculus of ureter
N20.2Calculus of kidney with calculus of ureter
N20.9Urinary calculus, unspecified
N22Calculus of urinary tract in diseases classified elsewhere
Group 2 Medical Necessity ICD-10 Codes Asterisk Explanation: M83.9* Use only for tumor-induced osteomalacia
E83.50* Use only for unexplained hypercalciuria
E83.52* Use only for unexplained hypercalcemia
Showing 1 to 17 of 17 entries in Group 2
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Additional ICD-10 Information
N/A-1>-2>

CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:

G0398HOME SLEEP STUDY TEST (HST) WITH TYPE II PORTABLE MONITOR, UNATTENDED; MINIMUM OF 7 CHANNELS: EEG, EOG, EMG, ECG/HEART RATE, AIRFLOW, RESPIRATORY EFFORT AND OXYGEN SATURATION

G0399HOME SLEEP TEST (HST) WITH TYPE III PORTABLE MONITOR, UNATTENDED; MINIMUM OF 4 CHANNELS: 2 RESPIRATORY MOVEMENT/AIRFLOW, 1 ECG/HEART RATE AND 1 OXYGEN SATURATION

G0400HOME SLEEP TEST (HST) WITH TYPE IV PORTABLE MONITOR, UNATTENDED; MINIMUM OF 3 CHANNELS

Group 2 Paragraph: CPT/HCPCS Codes Not Covered:


Group 2 Codes:

95803ACTIGRAPHY TESTING, RECORDING, ANALYSIS, INTERPRETATION, AND REPORT (MINIMUM OF 72 HOURS TO 14 CONSECUTIVE DAYS OF RECORDING)

95811POLYSOMNOGRAPHY; AGE 6 YEARS OR OLDER, SLEEP STAGING WITH 4 OR MORE ADDITIONAL PARAMETERS OF SLEEP, WITH INITIATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE THERAPY OR BILEVEL VENTILATION, ATTENDED BY A TECHNOLOGIST



Coverage Indications, Limitations, and/or Medical Necessity

Sleep disorder clinics are facilities in which certain conditions are diagnosed through the study of sleep. Such clinics are for diagnosis, therapy, and research. Sleep disorder clinics may provide some diagnostic or therapeutic services which are covered under Medicare. These clinics may be affiliated either with a hospital or a freestanding facility. Whether a clinic is hospital-affiliated or freestanding, coverage for diagnostic services under some circumstances is covered under provisions of the law different from those for coverage of therapeutic services. (CMS publication 100-02 Medicare Benefit Policy Manual, Chapter 15, Section 70)

The physician services related to home sleep testing are covered for the purpose of testing a patient for the diagnosis of obstructive sleep apnea if the home sleep testing is reasonable and necessary for the diagnosis of the patient’s condition, meets all other Medicare requirements, and the physician who performs the service has sufficient training and experience to reliably perform the service.

A home sleep test is covered only when it is performed in conjunction with a comprehensive sleep evaluation and in patients with a high pretest probability of moderate to severe obstructive sleep apnea.

Home sleep testing is not covered for persons with comorbidities (moderate to severe pulmonary disease, neuromuscular disease or congestive heart failure).

Home Sleep studies are only covered for the diagnosis of Obstructive Sleep Apnea. They are not covered for any other sleep disorders (central sleep apnea, periodic limb movement disorder, insomnia, parasomnias, circadian rhythm disorders or narcolepsy) or for screening asymptomatic persons.


A. Medical Conditions for Which Testing is Covered

Sleep Apnea- Apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% oxygen desaturation. This is a potentially lethal condition where the patient stops breathing during sleep. Three types of sleep apnea have been described (central, obstructive, and mixed). The nature of the apnea episodes can be documented by appropriate diagnostic testing.(CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 70).

Obstructive Sleep Apnea (OSA) is the collapse of the oropharyngeal walls and the obstruction of airflow occurring during sleep.

CMS PUB 100-03 NCD; 240.4.1 – Sleep Testing for Obstructive Sleep Apnea (OSA) finds that the evidence is sufficient to determine that the results of the sleep tests identified below can be used by a beneficiary’s treating physician to diagnose OSA:

B. Covered Home Sleep Testing Devices

1. Type II sleep testing devices are covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA.
Type II monitors have a minimum of 7 channels (e.g., EEG, EOG, EMG, ECG-heart rate, airflow, breathing/respiratory effort, SaO2)-this type of device monitors sleep staging, so AHI can be calculated).

2. Type III sleep testing devices are covered when used to aid the diagnosis of OSA in beneficiaries who have clinical signs and symptoms indicative of OSA.
Type III monitors have a minimum of 4 monitored channels including ventilation or airflow (at least two channels of respiratory movement or respiratory movement and airflow), heart rate or ECG, and oxygen saturation.

3. Type IV sleep testing devices measuring three or more channels, one of which is airflow, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA.

Type IV devices may measure one, two, three or more parameters but do not meet all the criteria of a higher category device.

Sleep testing devices measuring three or more channels that include actigraphy, oximetry, and peripheral arterial tone, are covered when used to aid the diagnosis of OSA in beneficiaries who have signs and symptoms indicative of OSA if performed unattended in or out of a sleep lab
facility or attended in a sleep lab facility.


C. Physician and Technician Requirements for Home Sleep Testing:

The physician performing the service must meet one of the following:
be a diplomate of the American Board of Sleep Medicine (ABSM) and
Board Certified Pulmonologist, or a Board Certified Neurologist or

has a Sleep Certification issued by one of the following Boards:
American Board of Internal Medicine (ABIM),
American Board of Family Medicine (ABFM),
American Board of Pediatrics (ABP),
American Board of Psychiatry and Neurology (ABPN),
American Board of Otolaryngology (ABOto),
American Osteopathic Board of Neurology and Psychiatry (AOBNP),
American Osteopathic Board of Family Medicine, (AOBFP)
American Osteopathic Board of Internal Medicine, (AOBIM)
American Osteopathic Board of Ophthalmology and Otorhinolaryngology (AOBOO), or

be an active staff member of an accredited sleep center or laboratory. The sleep facility accreditation must be from the American Academy of Sleep Medicine (AASM), inpatient or outpatient, or the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accreditation for Ambulatory care sleep centers.


Technician Credentials

The technician performing the service must meet one of the following:

American Board of Sleep Medicine (ABSM)
Registered Sleep Technologist (RST)

Board of Registered Polysomnographic Technologists (BRPT):
Registered Polysomnographic Technologist (RPSGT)

National Board for Respiratory Care (NBRC):
Certified Pulmonary Function Technologist (CPFT)
Registered Pulmonary Function Technologist (RPFT)
Certified Respiratory Therapist (CRT)
Registered Respiratory Therapist (RRT)

All centers billing sleep studies must maintain proper certification/ accreditation documentation as defined above, which include: Accreditation of sleep centers to include—AASM, or Joint Commission.


D. Actigraphy Testing:

Actigraphy measures movement of a limb. It can be measured as part of a sleep test but will not be paid for separately.

E. Home Sleep Testing (HST) is not covered in the following situations:

for the diagnosis of patients with chronic insomnia;
to preoperatively evaluate a patient undergoing a laser assisted uvulopalatopharyngoplasty without clinical evidence that obstructive sleep apnea is suspected;
to diagnose chronic lung disease (Nocturnal hypoxemia in patients with chronic, obstructive, restrictive, or reactive lung disease is usually adequately evaluated by oximetry. However, if the patient's symptoms suggest a diagnosis of obstructive sleep apnea, polysomnography is considered medically necessary);
in cases where seizure disorders have not been ruled out;
in cases of typical, uncomplicated, and non-injurious parasomnias when the diagnosis is clearly delineated
for patients with epilepsy who have no specific complaints consistent with a sleep disorder
for patients with symptoms suggestive of the periodic limb movement disorder or restless leg syndrome unless symptoms are suspected to be related to a covered indication
for the diagnosis of insomnia related to depression
for the diagnosis of circadian rhythm sleep disorders [i.e., rapid time-zone change (jet lag), shift-work sleep disorder, delayed sleep phase syndrome, advanced sleep phase syndrome, and non 24-hour sleep wake disorder].

Criteria for Coverage of Diagnostic Tests

All reasonable and necessary diagnostic tests given for the medical conditions listed in subsection B are covered when the following criteria are met:

The clinic is either affiliated with a hospital or is under the direction and control of physicians. Diagnostic testing routinely performed in sleep disorder clinics may be covered even in the absence of direct supervision by a physician;

Patients are referred to the sleep disorder clinic by their attending physicians, and the clinic maintains a record of the attending physician’s orders; and

The need for diagnostic testing is confirmed by medical evidence, e.g., physician examinations and laboratory tests.

Diagnostic testing that is duplicative of previous testing done by the attending physician to the extent the results are still pertinent is not covered because it is not reasonable and necessary under §1862(a)(1)(A) of the Act.


Home sleep studies/home sleep test may be considered medically necessary in adult patients (>18years of age) who are at high pre-test probability for moderate to severe obstructive sleep apnea (OSA), when ALL of the following criteria are met:

Patients considered high pre-test probability for moderate to severe OSA must have at least two of the following:
*Habitual snoring or gasping/choking episodes associated with awakenings;
*Observed apneas;
Excessive daytime sleepiness as evidenced by one of the following:
Questionnaires (Epworth Sleepiness Scale >10, Berlin, Wisconsin, STOP or STOP BANG)
Inappropriate day time napping (e.g. during driving, conversation or eating), or
sleepiness that interferes with daily activities not explained by other conditions;
A body mass index > 30 kg/m2;
Increased neck circumference >17 inches for men or >16 inches in women;
Morning headaches;
Sleep fragmentation or frequent unexplained arousals from sleep;
Decreased concentration/memory loss;
Treatment resistant hypertension/unexplained hypertension.
*If no bed partner is available to report snoring or observed apneas, the patient must still meet the criteria as it relates to other signs and symptoms suggestive of OSA.

AND

In addition, those patients eligible for an unattended home sleep study must have no evidence of a co-morbid medical condition including but not limited to any of the following as they might alter ventilation or require alternative treatment;
Moderate to Severe Pulmonary Disease
Congestive Heart Failure
Obesity hypoventilation syndrome
Neuromuscular disease (Parkinson’s, spina bifida, myotonic dystrophy, amyotrophic lateral sclerosis).


AND

Must not be suspected of having other sleep disorders including but not limited to the following;
Central sleep apnea
Periodic limb movement disorder
Restless leg syndrome
Insomnia
Parasomnias
Narcolepsy.


AND

Any one of the following sleep monitoring devices;
sleep monitoring using a Type II device; or
sleep monitoring using a Type III device; or
sleep monitoring using a Type IV(A) device, which must measure a minimum of three channels and must provide measurement of apnea-hypopnea index (AHI).

Unsupervised (unattended) home sleep studies/home sleep testing for an asymptomatic individual is considered not medically necessary.

Sleep studies using devices that do not provide a measurement of apnea-hypopnea index (AHI) and oxygen saturation are considered not medically necessary because they do not provide sufficient information to prescribe treatment.


Notes

See Description information above for a full description of sleep monitoring devices.
Respiratory disturbance index (RDI) may be used in place of apnea/hypopnea index (AHI) in unattended sleep studies.

Unsupervised (unattended) home sleep study/home sleep test is typically performed over multiple nights with a single interpretation and is considered a single sleep study for purposes of reimbursement.

When a diagnosis of OSA is established following a home sleep study/home sleep test (portable study), home titration to determine a fixed CPAP pressure can be effectively completed using auto-titrating positive airway pressure. Evidence from several well-designed trials demonstrates that home PAP titration using APAP compared to in-facility titration results in similar outcomes in terms of improvement in AHI, Epworth Sleepiness scores, and CPAP acceptance and adherence. Therefore laboratory CPAP titration following unattended or home sleep testing is not considered medically necessary.


Repeat unsupervised (unattended) home sleep studies/home sleep testing may be considered medically necessary in adult patients for any of the following reasons;

To assess efficacy of surgery or oral appliances/devices.
A non-diagnostic home study within the past 3 months (e.g. technical complications or negative test with a high pretest probability of OSA).
Failure of resolution of symptoms or recurrence of symptoms during treatment.
To re-evaluate the diagnosis of OSA and need for continued PAP therapy (e.g. if there is a significant change in weight or change in symptoms suggesting that PAP therapy should be adjusted or possibly discontinued).



Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
N/A


ICD-10 Codes that Support Medical Necessity


ICD-10 CODEDESCRIPTION

G47.10Hypersomnia, unspecified

G47.13Recurrent hypersomnia

G47.14Hypersomnia due to medical condition

G47.19Other hypersomnia

G47.30Sleep apnea, unspecified

G47.33Obstructive sleep apnea (adult) (pediatric)

CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:

96360Hydration iv infusion init
96361Hydrate iv infusion add-on



Coverage Indications, Limitations, and/or Medical Necessity



Indications

The clinical manifestations of dehydration or volume depletion are related to the volume and rate of fluid loss, the nature of the fluid that is lost, and the responsiveness of the vasculature to volume reduction. Rehydration with fluids containing sodium as the principal solute preferentially expands the extracellular fluid volume; a 1-liter infusion of normal saline may expand blood volume by about 300 ml. In general, an imbalance of less than 500 ml of volume is not likely to require intravenous rehydration.

Hydration services are indicated:

In documented volume depletion.

When performed in conjunction with chemotherapy, these CPT codes are covered only when infusion is prolonged and done sequentially [done hour(s) before and/or after administration of chemotherapy], and when the volume status of a patient is compromised or will be compromised by side effects of chemotherapy or an illness.

In some endocrine conditions with findings such as hypercalcemia, prolonged hydration can be medically necessary.

As an adjunct to the treatment of hypotension.
Limitations

Rehydration with the administration of an amount of fluid equal to or less than 500 ml is not reasonable and necessary.

These CPT codes are not to be used for routine IV drug injections.

Hanging of D5W or other fluid just prior to administration of chemotherapy is not hydration therapy and should not be billed with these codes.

When the sole purpose of fluid administration is to maintain patency of the access device, these infusion CPT codes should not be billed as hydration therapy.

Administration of fluid in the course of transfusions to maintain line patency or between units of blood product is not to be separately billed as hydration therapy.

Fluid used to administer drug(s) is incidental hydration and is not separately payable.

Rehydration via hydration therapy of extensively dehydrated patients can be accomplished in hours; therefore, the medical necessity of hydration beyond 12 hours must be documented in the medical record.

These CPT codes require the direct supervision of the physician or non-physician practitioner for the initiation of the service.




Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
N/A



Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

N/A




ICD-10 Codes that Support Medical Necessity


ICD-10 CODEDESCRIPTION

E11.649 - E11.69 - Opens in a new windowType 2 diabetes mellitus with hypoglycemia without coma - Type 2 diabetes mellitus with other specified complication

E13.649 - E13.69 - Opens in a new windowOther specified diabetes mellitus with hypoglycemia without coma - Other
specified diabetes mellitus with other specified complication

E83.52Hypercalcemia

E86.0 - E87.0 - Opens in a new windowDehydration - Hyperosmolality and hypernatremia

I95.9Hypotension, unspecified

K29.00 - K29.91 - Opens in a new windowAcute gastritis without bleeding - Gastroduodenitis, unspecified, with bleeding

K52.89 - K52.9 - Opens in a new windowOther specified noninfective gastroenteritis and colitis - Noninfective
gastroenteritis and colitis, unspecified

K92.0Hematemesis

N18.3Chronic kidney disease, stage 3 (moderate)

O21.1 - O21.8 - Opens in a new windowHyperemesis gravidarum with metabolic disturbance - Other vomiting complicating
pregnancy

R11.10 - R11.12 - Opens in a new windowVomiting, unspecified - Projectile vomiting

R11.2Nausea with vomiting, unspecified

R19.7Diarrhea, unspecified

R41.0Disorientation, unspecified

R41.82Altered mental status, unspecified

R42Dizziness and giddiness

R55Syncope and collapse

Z51.11Encounter for antineoplastic chemotherapy

Z91.89Other specified personal risk factors, not elsewhere classified

CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:
93224Ecg monit/reprt up to 48 hrs
93225Ecg monit/reprt up to 48 hrs
93226Ecg monit/reprt up to 48 hrs
93227Ecg monit/reprt up to 48 hrs
93228Remote 30 day ecg rev/report
93229Remote 30 day ecg tech supp
93268Ecg record/review
93270Remote 30 day ecg rev/report
93271Ecg/monitoring and analysis
93272Ecg/review interpret only

CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:
92585Auditor evoke potent compre
92586Auditor evoke potent limit

Group 2 Paragraph: N/A

Group 2 Codes:
95925Somatosensory testing
95926Somatosensory testing
95927Somatosensory testing
95928C motor evoked uppr limbs
95929C motor evoked lwr limbs
95938Somatosensory testing
95939C motor evoked upr&lwr limbs

Group 3 Paragraph: N/A

Group 3 Codes:
95930Visual evoked potential test



Coverage Indications, Limitations, and/or Medical Necessity

Background

Neurophysiology Evoked Potentials (NEPs) for the purpose of this LCD include:

Somatosensory Evoked Potentials/Responses (SEPs/SERs),
Brainstem Auditory Evoked Potentials/Responses (BAEPs/BAERs), and
Visual Evoked Potentials/Responses (VEPs/VERs)
Evoked potential studies are recorded electrical responses to stimulation of a sensory system. When a sensory impulse reaches the brain, a specific Electroencephalographic (EEG) response is produced (evoked) in the cortical area appropriate to the modality and site of the stimulus. By computer averaging techniques, the evoked responses of repetitive stimuli can be separated from the spontaneous EEG activity. Evoked potentials are clinically useful in evaluating the functional integrity of the somatosensory or special sensory pathways. Different latencies and wave patterns help to localize lesions ranging from the end organ through the nervous system to the cerebral cortex. Often defects in these pathways are not otherwise evident. Evoked potentials are also used to monitor neural pathways when patients are anesthetized during surgery and to document brain death. The following are tests that evaluate potentials evoked by stimulation of the peripheral or cranial nerves:

SEPs/SERs evaluate the pathways from nerves in the extremities through the spinal cord, to the brainstem or cerebral cortex upon stimulation of peripheral axon.

SEPs has an advantage in that it evaluates the entire somatosensory pathway and it is possible to distinguish between lesions located in the peripheral nerve, in the dorsal column pathway, or both.

VEPs/VERs evaluate the visual nervous system pathways from the eyes to the occipital cortex of the brain. VEP or VER involves stimulation of the retina and optic nerve with a shifting checkerboard pattern or flash method. This external visual stimulus causes measurable electrical activity in neurons within the visual pathways. This is called the Visual Evoked Response (VER) and is recorded by electroencephalography electrodes located over the occiput. Using special computer techniques, the evoked responses measured over multiple trials are amplified and averaged. A characteristic waveform is produced. With pattern-shift VER, the waveform normally appears as a straight line with a single positive peak (100 msec after stimulus presentation). Abnormalities in this characteristic waveform may be seen in a variety of pathologic processes involving the optic nerve and its radiations. Pattern-shift VER is a highly sensitive means of documenting lesions in the visual system. It is especially useful when the disease process is subclinical, e.g., ophthalmologic exam is normal and patient lacks visual symptoms.

BAEPs/BAERs evaluate the auditory nerve pathways from the ears through the brain stem. A clicking sound is presented to one ear at a time. The electrical activity of this signal is recorded by electrodes on the scalp. The averaged response is displayed as a waveform that contains peaks and troughs, which correspond to various points along the hearing pathway. The time between these peaks is measured and compared to normal data. A delay in a component of the response might indicate an abnormality at specific anatomic sites in the acoustic nerve or brainstem.


Indications

Somatosensory Evoked Potentials and Responses (SEPs/SERs) (CPT codes 95925, 95926, 95927, 95928, 95929, 95938, 95939) are appropriate for the following indications:

Spinal cord trauma
Degenerative, non-traumatic spinal cord lesions (e.g., cervical spondylosis with myelopathy)
Multiple sclerosis
Spinocerebellar degeneration
Myoclonus
Coma
Intraoperative monitoring
Subacute combined degeneration
Other diseases of myelin (e.g., adrenoleukodystrophy, adrenomyeloneuropathy, metachromatic leukodystrophy, and Pelizaeus-Merzbacher disease
Syringomyelia
Hereditary spastic paraplegia
Brainstem Auditory Evoked Potentials and Responses (BAEPs/BAERs) (CPT codes 92585 and 92586) are appropriate:

For one or more of the following conditions:

Asymmetric hearing loss
Unilateral tinnitus
Sudden hearing loss
Cerebellopontine angle tumor
Demyelinating disorder
Functional hearing loss
Ototoxic drug therapy monitoring including chemotherapy or antibiotics
Auditory neuropathy
Acoustic neuroma

Preoperative baseline for:

Posterior fossa surgery
Cochlear implant

Postoperative testing for:

Cochlear implant
Visual Evoked Potentials or Responses (VEPs/VERs) (CPT code 95930) are appropriate for the following indications:

Confirm diagnosis of multiple sclerosis when clinical criteria are inconclusive.

Detect optic neuritis at an early, subclinical stage.

Evaluate diseases of the optic nerve, such as:

Ischemic optic neuropathy
Pseudotumor cerebri
Toxic amblyopias
Nutritional amblyopias
Neoplasms compressing the anterior visual pathways
Optic nerve injury or atrophy
Hysterical blindness (to rule out)

Monitor the visual system during optic nerve (or related) surgery (monitoring of short-latency evoked potential studies).

Limitations

SEP studies are appropriate only when a detailed clinical history and neurologic examination and appropriate diagnostic tests such as imaging studies, electromyogram, and nerve conduction studies make a lesion (or lesions) of the central somatosensory pathways a likely and reasonable differential diagnostic possibility.

There is no need for SEPs in the diagnosis of most neuropathies because the conventional nerve conduction study can identify them and no added information is obtained from SEPs.



ICD-10 Codes that Support Medical Necessity


ICD-10 CODEDESCRIPTION

D33.3Benign neoplasm of cranial nerves
G10Huntington's disease
G21.0Malignant neuroleptic syndrome
G23.0 - G26 - Opens in a new windowHallervorden-Spatz disease - Extrapyramidal and movement disorders in diseases classified elsewhere
G35 - G36.8 - Opens in a new windowMultiple sclerosis - Other specified acute disseminated demyelination
G37.0 - G37.8 - Opens in a new windowDiffuse sclerosis of central nervous system - Other specified demyelinating diseases of central nervous system
G80.3Athetoid cerebral palsy
G90.3Multi-system degeneration of the autonomic nervous system
H46.00 - H46.9 - Opens in a new windowOptic papillitis, unspecified eye - Unspecified optic neuritis
H81.01 - H81.09 - Opens in a new windowMeniere's disease, right ear - Meniere's disease, unspecified ear
H81.41 - H81.49 - Opens in a new windowVertigo of central origin, right ear - Vertigo of central origin, unspecified ear
H83.3X1 - H83.3X9 - Opens in a new windowNoise effects on right inner ear - Noise effects on inner ear, unspecified ear
H90.3 - H90.8 - Opens in a new windowSensorineural hearing loss, bilateral - Mixed conductive and sensorineural hearing loss, unspecified
H91.20 - H91.23 - Opens in a new windowSudden idiopathic hearing loss, unspecified ear - Sudden idiopathic hearing loss, bilateral
H93.11 - H93.19 - Opens in a new windowTinnitus, right ear - Tinnitus, unspecified ear
H93.3X1 - H93.3X9 - Opens in a new windowDisorders of right acoustic nerve - Disorders of unspecified acoustic nerve
H94.00 - H94.03 - Opens in a new windowAcoustic neuritis in infectious and parasitic diseases classified elsewhere, unspecified ear - Acoustic neuritis in infectious and parasitic diseases classified elsewhere, bilateral
R25.0 - R25.9 - Opens in a new windowAbnormal head movements - Unspecified abnormal involuntary movements
R42Dizziness and giddiness



ICD-10 CODEDESCRIPTION

A18.01Tuberculosis of spine
A52.11Tabes dorsalis
A52.13 - A52.15 - Opens in a new windowLate syphilitic meningitis - Late syphilitic neuropathy
A52.17 - A52.19 - Opens in a new windowGeneral paresis - Other symptomatic neurosyphilis
A69.20 - A69.22 - Opens in a new windowLyme disease, unspecified - Other neurologic disorders in Lyme disease
A69.29Other conditions associated with Lyme disease
A83.0 - A83.8 - Opens in a new windowJapanese encephalitis - Other mosquito-borne viral encephalitis
A84.0 - A84.8 - Opens in a new windowFar Eastern tick-borne encephalitis [Russian spring-summer encephalitis] - Other tick-borne viral encephalitis
A85.2Arthropod-borne viral encephalitis, unspecified
B00.4Herpesviral encephalitis
B00.82Herpes simplex myelitis
B02.24Postherpetic myelitis
B05.0Measles complicated by encephalitis
B06.01Rubella encephalitis
C41.2Malignant neoplasm of vertebral column
C70.0 - C70.9 - Opens in a new windowMalignant neoplasm of cerebral meninges - Malignant neoplasm of meninges, unspecified
C72.0 - C72.9 - Opens in a new windowMalignant neoplasm of spinal cord - Malignant neoplasm of central nervous system, unspecified
C79.31 - C79.49 - Opens in a new windowSecondary malignant neoplasm of brain - Secondary malignant neoplasm of other parts of nervous system
D32.0 - D33.7 - Opens in a new windowBenign neoplasm of cerebral meninges - Benign neoplasm of other specified parts of central nervous system
D42.0 - D43.2 - Opens in a new windowNeoplasm of uncertain behavior of cerebral meninges - Neoplasm of uncertain behavior of brain, unspecified
D43.4Neoplasm of uncertain behavior of spinal cord
D44.3 - D44.5 - Opens in a new windowNeoplasm of uncertain behavior of pituitary gland - Neoplasm of uncertain behavior of pineal gland
D49.6Neoplasm of unspecified behavior of brain
E03.5Myxedema coma
E08.40Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
E08.42Diabetes mellitus due to underlying condition with diabetic polyneuropathy
E08.44Diabetes mellitus due to underlying condition with diabetic amyotrophy
E09.40Drug or chemical induced diabetes mellitus with neurological complications with diabetic neuropathy, unspecified
E09.42Drug or chemical induced diabetes mellitus with neurological complications with diabetic polyneuropathy
E09.44Drug or chemical induced diabetes mellitus with neurological complications with diabetic amyotrophy
E10.40Type 1 diabetes mellitus with diabetic neuropathy, unspecified
E10.42Type 1 diabetes mellitus with diabetic polyneuropathy
E10.44Type 1 diabetes mellitus with diabetic amyotrophy
E11.40Type 2 diabetes mellitus with diabetic neuropathy, unspecified
E11.42Type 2 diabetes mellitus with diabetic polyneuropathy
E11.44Type 2 diabetes mellitus with diabetic amyotrophy
E13.40Other specified diabetes mellitus with diabetic neuropathy, unspecified
E13.42Other specified diabetes mellitus with diabetic polyneuropathy
E13.44Other specified diabetes mellitus with diabetic amyotrophy
E71.50 - E71.548 - Opens in a new windowPeroxisomal disorder, unspecified - Other peroxisomal disorders
E75.23Krabbe disease
E75.25 - E75.29 - Opens in a new windowMetachromatic leukodystrophy - Other sphingolipidosis
F44.4 - F44.7 - Opens in a new windowConversion disorder with motor symptom or deficit - Conversion disorder with mixed symptom presentation
G05.4Myelitis in diseases classified elsewhere
G06.1Intraspinal abscess and granuloma
G11.0 - G11.8 - Opens in a new windowCongenital nonprogressive ataxia - Other hereditary ataxias
G13.0 - G13.1 - Opens in a new windowParaneoplastic neuromyopathy and neuropathy - Other systemic atrophy primarily affecting central nervous system in neoplastic disease
G23.0 - G23.9 - Opens in a new windowHallervorden-Spatz disease - Degenerative disease of basal ganglia, unspecified
G32.0 - G32.81 - Opens in a new windowSubacute combined degeneration of spinal cord in diseases classified elsewhere - Cerebellar ataxia in diseases classified elsewhere
G35 - G36.8 - Opens in a new windowMultiple sclerosis - Other specified acute disseminated demyelination
G37.0 - G37.8 - Opens in a new windowDiffuse sclerosis of central nervous system - Other specified demyelinating diseases of central nervous system
G45.0 - G45.2 - Opens in a new windowVertebro-basilar artery syndrome - Multiple and bilateral precerebral artery syndromes
G45.8Other transient cerebral ischemic attacks and related syndromes
G46.0 - G46.2 - Opens in a new windowMiddle cerebral artery syndrome - Posterior cerebral artery syndrome
G54.0 - G54.8 - Opens in a new windowBrachial plexus disorders - Other nerve root and plexus disorders
G55Nerve root and plexus compressions in diseases classified elsewhere
G56.40 - G56.42 - Opens in a new windowCausalgia of unspecified upper limb - Causalgia of left upper limb
G57.00 - G57.92 - Opens in a new windowLesion of sciatic nerve, unspecified lower limb - Unspecified mononeuropathy of left lower limb
G58.7Mononeuritis multiplex
G60.0 - G60.8 - Opens in a new windowHereditary motor and sensory neuropathy - Other hereditary and idiopathic neuropathies
G61.0 - G61.89 - Opens in a new windowGuillain-Barre syndrome - Other inflammatory polyneuropathies
G62.0 - G62.89 - Opens in a new windowDrug-induced polyneuropathy - Other specified polyneuropathies
G63Polyneuropathy in diseases classified elsewhere
G65.0 - G70.89 - Opens in a new windowSequelae of Guillain-Barre syndrome - Other specified myoneural disorders
G73.1 - G73.3 - Opens in a new windowLambert-Eaton syndrome in neoplastic disease - Myasthenic syndromes in other diseases classified elsewhere
G80.0 - G80.2 - Opens in a new windowSpastic quadriplegic cerebral palsy - Spastic hemiplegic cerebral palsy
G80.4 - G80.8 - Opens in a new windowAtaxic cerebral palsy - Other cerebral palsy
G81.00 - G81.94 - Opens in a new windowFlaccid hemiplegia affecting unspecified side - Hemiplegia, unspecified affecting left nondominant side
G90.3Multi-system degeneration of the autonomic nervous system
G93.2Benign intracranial hypertension
G95.0 - G95.19 - Opens in a new windowSyringomyelia and syringobulbia - Other vascular myelopathies
G95.81 - G95.89 - Opens in a new windowConus medullaris syndrome - Other specified diseases of spinal cord
G99.2Myelopathy in diseases classified elsewhere
I60.00 - I62.1 - Opens in a new windowNontraumatic subarachnoid hemorrhage from unspecified carotid siphon and bifurcation - Nontraumatic extradural hemorrhage
I63.011 - I63.09 - Opens in a new windowCerebral infarction due to thrombosis of right vertebral artery - Cerebral infarction due to thrombosis of other precerebral artery
I63.111 - I63.19 - Opens in a new windowCerebral infarction due to embolism of right vertebral artery - Cerebral infarction due to embolism of other precerebral artery
I63.211 - I63.239 - Opens in a new windowCerebral infarction due to unspecified occlusion or stenosis of right vertebral arteries - Cerebral infarction due to unspecified occlusion or stenosis of unspecified carotid arteries
I63.30 - I63.49 - Opens in a new windowCerebral infarction due to thrombosis of unspecified cerebral artery - Cerebral infarction due to embolism of other cerebral artery
I63.59 - I63.6 - Opens in a new windowCerebral infarction due to unspecified occlusion or stenosis of other cerebral artery - Cerebral infarction due to cerebral venous thrombosis, nonpyogenic
I65.01 - I65.8 - Opens in a new windowOcclusion and stenosis of right vertebral artery - Occlusion and stenosis of other precerebral arteries
I66.01 - I66.3 - Opens in a new windowOcclusion and stenosis of right middle cerebral artery - Occlusion and stenosis of cerebellar arteries
I66.9Occlusion and stenosis of unspecified cerebral artery
I67.1Cerebral aneurysm, nonruptured
M05.50 - M05.59 - Opens in a new windowRheumatoid polyneuropathy with rheumatoid arthritis of unspecified site - Rheumatoid polyneuropathy with rheumatoid arthritis of multiple sites
M34.83Systemic sclerosis with polyneuropathy
M40.00 - M41.9 - Opens in a new windowPostural kyphosis, site unspecified - Scoliosis, unspecified
M43.8X1 - M43.9 - Opens in a new windowOther specified deforming dorsopathies, occipito-atlanto-axial region - Deforming dorsopathy, unspecified
M47.011 - M47.029 - Opens in a new windowAnterior spinal artery compression syndromes, occipito-atlanto-axial region - Vertebral artery compression syndromes, site unspecified
M47.11 - M47.16 - Opens in a new windowOther spondylosis with myelopathy, occipito-atlanto-axial region - Other spondylosis with myelopathy, lumbar region
M50.00 - M50.03 - Opens in a new windowCervical disc disorder with myelopathy, unspecified cervical region - Cervical disc disorder with myelopathy, cervicothoracic region
M51.04 - M51.06 - Opens in a new windowIntervertebral disc disorders with myelopathy, thoracic region - Intervertebral disc disorders with myelopathy, lumbar region
M51.9 - M53.1 - Opens in a new windowUnspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder - Cervicobrachial syndrome
M96.2 - M96.5 - Opens in a new windowPostradiation kyphosis - Postradiation scoliosis
Q05.0 - Q05.9 - Opens in a new windowCervical spina bifida with hydrocephalus - Spina bifida, unspecified
Q07.00 - Q07.03 - Opens in a new windowArnold-Chiari syndrome without spina bifida or hydrocephalus - Arnold-Chiari syndrome with spina bifida and hydrocephalus
R20.0 - R20.9 - Opens in a new windowAnesthesia of skin - Unspecified disturbances of skin sensation
R26.0 - R26.1 - Opens in a new windowAtaxic gait - Paralytic gait
R26.81 - R27.9 - Opens in a new windowUnsteadiness on feet - Unspecified lack of coordination
R29.5Transient paralysis

CPT/HCPCS Codes

Group 1 Codes:
72192Ct pelvis w/o dye
72193Ct pelvis w/dye
72194Ct pelvis w/o & w/dye
74150Ct abdomen w/o dye
74160Ct abdomen w/dye
74170Ct abdomen w/o & w/dye
74176Ct abd & pelvis w/o contrast
74177Ct abd & pelv w/contrast
74178Ct abd & pelv 1/> regns

Coverage Indications, Limitations, and/or Medical Necessity

Indications

Evaluation of abdominal or pelvic pain.

Evaluation of known or suspected abdominal or pelvic masses or fluid collections, primary or metastatic malignancies, abdominal or pelvic inflammatory processes, and abnormalities of abdominal or pelvic vascular structures.

Evaluation of abdominal or pelvic trauma.

Clarification of findings from other imaging studies or laboratory abnormalities.

Evaluation of known or suspected congenital abnormalities of abdominal or pelvic organs.

Treatment planning for radiation therapy.

Limitations

Three dimension reconstruction of CT of Abdomen and Pelvis (CPT code 76376 or 76377) is not expected to be utilized routinely. CPT code 76376 or 76377 are not an appropriate part of every CT examination.


Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
999xNot Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999Not Applicable



ICD-10 Codes that Support Medical Necessity


ICD-10 CODEDESCRIPTION

A06.2 - A06.6 - Opens in a new windowAmebic nondysenteric colitis - Amebic brain abscess
A06.81 - A06.89 - Opens in a new windowAmebic cystitis - Other amebic infections
A18.10 - A18.18 - Opens in a new windowTuberculosis of genitourinary system, unspecified - Tuberculosis of other female genital organs
A18.31 - A18.39 - Opens in a new windowTuberculous peritonitis - Retroperitoneal tuberculosis
A18.7Tuberculosis of adrenal glands
A18.83Tuberculosis of digestive tract organs, not elsewhere classified
A18.85Tuberculosis of spleen
A31.0Pulmonary mycobacterial infection
A31.2Disseminated mycobacterium avium-intracellulare complex (DMAC)
A34Obstetrical tetanus
A39.1Waterhouse-Friderichsen syndrome
A40.0 - A41.9 - Opens in a new windowSepsis due to streptococcus, group A - Sepsis, unspecified organism
A42.7Actinomycotic sepsis
A50.04Early congenital syphilitic pneumonia
A50.06 - A50.09 - Opens in a new windowEarly cutaneous congenital syphilis - Other early congenital syphilis, symptomatic
A51.49Other secondary syphilitic conditions
A52.74 - A52.75 - Opens in a new windowSyphilis of liver and other viscera - Syphilis of kidney and ureter
A56.11Chlamydial female pelvic inflammatory disease
B15.0 - B19.9 - Opens in a new windowHepatitis A with hepatic coma - Unspecified viral hepatitis without hepatic coma
B25.1 - B25.2 - Opens in a new windowCytomegaloviral hepatitis - Cytomegaloviral pancreatitis
B37.7Candidal sepsis
B65.0 - B65.9 - Opens in a new windowSchistosomiasis due to Schistosoma haematobium [urinary schistosomiasis] - Schistosomiasis, unspecified
B67.0Echinococcus granulosus infection of liver
B67.5Echinococcus multilocularis infection of liver
B67.8 - B67.99 - Opens in a new windowEchinococcosis, unspecified, of liver - Other echinococcosis
C00.0 - C43.9 - Opens in a new windowMalignant neoplasm of external upper lip - Malignant melanoma of skin, unspecified
C4A.0 - C4A.9 - Opens in a new windowMerkel cell carcinoma of lip - Merkel cell carcinoma, unspecified
C44.00 - C49.9 - Opens in a new windowUnspecified malignant neoplasm of skin of lip - Malignant neoplasm of connective and soft tissue, unspecified
C50.011 - C75.9 - Opens in a new windowMalignant neoplasm of nipple and areola, right female breast - Malignant neoplasm of endocrine gland, unspecified
C7A.00 - C7B.8 - Opens in a new windowMalignant carcinoid tumor of unspecified site - Other secondary neuroendocrine tumors
C76.0 - C79.9 - Opens in a new windowMalignant neoplasm of head, face and neck - Secondary malignant neoplasm of unspecified site
C80.0 - C84.79 - Opens in a new windowDisseminated malignant neoplasm, unspecified - Anaplastic large cell lymphoma, ALK-negative, extranodal and solid organ sites
C84.A0 - C84.Z9 - Opens in a new windowCutaneous T-cell lymphoma, unspecified, unspecified site - Other mature T/NK-cell lymphomas, extranodal and solid organ sites
C84.90 - C84.99 - Opens in a new windowMature T/NK-cell lymphomas, unspecified, unspecified site - Mature T/NK-cell lymphomas, unspecified, extranodal and solid organ sites
C85.10 - C86.6 - Opens in a new windowUnspecified B-cell lymphoma, unspecified site - Primary cutaneous CD30-positive T-cell proliferations
C88.2 - C91.62 - Opens in a new windowHeavy chain disease - Prolymphocytic leukemia of T-cell type, in relapse
C91.A0 - C91.Z2 - Opens in a new windowMature B-cell leukemia Burkitt-type not having achieved remission - Other lymphoid leukemia, in relapse
C91.90 - C91.92 - Opens in a new windowLymphoid leukemia, unspecified not having achieved remission - Lymphoid leukemia, unspecified, in relapse
C92.00 - C92.62 - Opens in a new windowAcute myeloblastic leukemia, not having achieved remission - Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 - C92.Z2 - Opens in a new windowAcute myeloid leukemia with multilineage dysplasia, not having achieved remission - Other myeloid leukemia, in relapse
C92.90 - C92.92 - Opens in a new windowMyeloid leukemia, unspecified, not having achieved remission - Myeloid leukemia, unspecified in relapse
C93.00 - C93.32 - Opens in a new windowAcute monoblastic/monocytic leukemia, not having achieved remission - Juvenile myelomonocytic leukemia, in relapse
C93.Z0 - C93.Z2 - Opens in a new windowOther monocytic leukemia, not having achieved remission - Other monocytic leukemia, in relapse
C93.90 - C93.92 - Opens in a new windowMonocytic leukemia, unspecified, not having achieved remission - Monocytic leukemia, unspecified in relapse
C94.00 - C94.32 - Opens in a new windowAcute erythroid leukemia, not having achieved remission - Mast cell leukemia, in relapse
C94.80 - C96.4 - Opens in a new windowOther specified leukemias not having achieved remission - Sarcoma of dendritic cells (accessory cells)
C96.A - C96.Z - Opens in a new windowHistiocytic sarcoma - Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue
C96.9Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified
D00.1 - D01.9 - Opens in a new windowCarcinoma in situ of esophagus - Carcinoma in situ of digestive organ, unspecified
D03.0 - D03.9 - Opens in a new windowMelanoma in situ of lip - Melanoma in situ, unspecified
D06.0 - D09.19 - Opens in a new windowCarcinoma in situ of endocervix - Carcinoma in situ of other urinary organs
D12.0 - D12.9 - Opens in a new windowBenign neoplasm of cecum - Benign neoplasm of anus and anal canal
D13.1 - D13.9 - Opens in a new windowBenign neoplasm of stomach - Benign neoplasm of ill-defined sites within the digestive system
D16.8Benign neoplasm of pelvic bones, sacrum and coccyx
D17.5Benign lipomatous neoplasm of intra-abdominal organs
D17.71Benign lipomatous neoplasm of kidney
D18.03Hemangioma of intra-abdominal structures
D18.1Lymphangioma, any site
D19.1Benign neoplasm of mesothelial tissue of peritoneum
D20.0 - D20.1 - Opens in a new windowBenign neoplasm of soft tissue of retroperitoneum - Benign neoplasm of soft tissue of peritoneum
D21.20 - D21.22 - Opens in a new windowBenign neoplasm of connective and other soft tissue of unspecified lower limb, including hip - Benign neoplasm of connective and other soft tissue of left lower limb, including hip
D21.4 - D21.5 - Opens in a new windowBenign neoplasm of connective and other soft tissue of abdomen - Benign neoplasm of connective and other soft tissue of pelvis
D25.0 - D28.9 - Opens in a new windowSubmucous leiomyoma of uterus - Benign neoplasm of female genital organ, unspecified
D30.00 - D30.9 - Opens in a new windowBenign neoplasm of unspecified kidney - Benign neoplasm of urinary organ, unspecified
D35.00 - D35.02 - Opens in a new windowBenign neoplasm of unspecified adrenal gland - Benign neoplasm of left adrenal gland
D35.6Benign neoplasm of aortic body and other paraganglia
D3A.00 - D3A.8 - Opens in a new windowBenign carcinoid tumor of unspecified site - Other benign neuroendocrine tumors
D37.1 - D37.9 - Opens in a new windowNeoplasm of uncertain behavior of stomach - Neoplasm of uncertain behavior of digestive organ, unspecified
D39.0 - D39.9 - Opens in a new windowNeoplasm of uncertain behavior of uterus - Neoplasm of uncertain behavior of female genital organ, unspecified
D40.0 - D41.9 - Opens in a new windowNeoplasm of uncertain behavior of prostate - Neoplasm of uncertain behavior of unspecified urinary organ
D44.10 - D44.12 - Opens in a new windowNeoplasm of uncertain behavior of unspecified adrenal gland - Neoplasm of uncertain behavior of left adrenal gland
D44.6 - D44.7 - Opens in a new windowNeoplasm of uncertain behavior of carotid body - Neoplasm of uncertain behavior of aortic body and other paraganglia
D45Polycythemia vera
D48.3 - D48.4 - Opens in a new windowNeoplasm of uncertain behavior of retroperitoneum - Neoplasm of uncertain behavior of peritoneum
D49.0Neoplasm of unspecified behavior of digestive system
D57.02Hb-SS disease with splenic sequestration
D57.212Sickle-cell/Hb-C disease with splenic sequestration
D57.412Sickle-cell thalassemia with splenic sequestration
D57.812Other sickle-cell disorders with splenic sequestration
D73.1 - D73.2 - Opens in a new windowHypersplenism - Chronic congestive splenomegaly
D73.81Neutropenic splenomegaly
D75.0 - D75.1 - Opens in a new windowFamilial erythrocytosis - Secondary polycythemia
D78.01 - D78.22 - Opens in a new windowIntraoperative hemorrhage and hematoma of the spleen complicating a procedure on the spleen - Postprocedural hemorrhage of the spleen following other procedure
D86.0 - D86.2 - Opens in a new windowSarcoidosis of lung - Sarcoidosis of lung with sarcoidosis of lymph nodes
D86.84Sarcoid pyelonephritis
D86.89 - D86.9 - Opens in a new windowSarcoidosis of other sites - Sarcoidosis, unspecified
E08.51 - E08.52 - Opens in a new windowDiabetes mellitus due to underlying condition with diabetic peripheral angiopathy without gangrene - Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy with gangrene
E09.51 - E09.52 - Opens in a new windowDrug or chemical induced diabetes mellitus with diabetic peripheral angiopathy without gangrene - Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy with gangrene
E10.51 - E10.52 - Opens in a new windowType 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene - Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene
E11.51 - E11.52 - Opens in a new windowType 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene - Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene
E13.51 - E13.52 - Opens in a new windowOther specified diabetes mellitus with diabetic peripheral angiopathy without gangrene - Other specified diabetes mellitus with diabetic peripheral angiopathy with gangrene
E16.3 - E16.8 - Opens in a new windowIncreased secretion of glucagon - Other specified disorders of pancreatic internal secretion
E24.0Pituitary-dependent Cushing's disease
E24.2 - E27.9 - Opens in a new windowDrug-induced Cushing's syndrome - Disorder of adrenal gland, unspecified
E28.2Polycystic ovarian syndrome
E35 - E36.12 - Opens in a new windowDisorders of endocrine glands in diseases classified elsewhere - Accidental puncture and laceration of an endocrine system organ or structure during other procedure
E74.00 - E74.09 - Opens in a new windowGlycogen storage disease, unspecified - Other glycogen storage disease
E83.10 - E83.19 - Opens in a new windowDisorder of iron metabolism, unspecified - Other disorders of iron metabolism
E84.0 - E85.9 - Opens in a new windowCystic fibrosis with pulmonary manifestations - Amyloidosis, unspecified
E89.6Postprocedural adrenocortical (-medullary) hypofunction

CPT/HCPCS Codes:

96910 Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B

96912 Photochemotherapy; psoralens and ultraviolet A (PUVA)


96913 Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least four to eight hours of care under direct supervision of the physician (includes application of medication and dressings)


96920 Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq. cm

96921 Laser treatment for inflammatory skin disease (psoriasis); 250 sq. cm to 500 sq. cm


96922 Laser treatment for inflammatory skin disease (psoriasis); over 500 sq. cm

DESCRIPTION 2014 Total  RVUs1 2013 Total RVUs2 Total RVUs % Difference 2014 payment in $ assuming 35.6653 CF3


96900: Ultraviolet light therapy 0.58 0.65 -10.77% $20.69 $22.11 -6.46% 97,972

96910: Photochemotherapy with uv-b 1.10 2.24 -50.89% $39.23 $76.21 -48.52% 383,029

96912: Photochemotherapy with uv-a 1.10 2.87 -61.67% $39.23 $97.65 -59.82% 34,307


Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable service codes: 96900, 96912, 96913, 96920, 96921, 96922 There is no specific CPT code for laser therapy for vitiligo. It should currently be reported using the unlisted CPT 96999, but the CPT codes for laser therapy for psoriasis (96920-96922) might be used. BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information neede  to make a medical necessity determination is included

How Treatment Codes 96900, 96910, and 96912 are used: Phototherapy or light therapy, is a first-line treatment for psoriasis and involves exposing the skin to ultraviolet light B (UVB) or ultraviolet light A (UVA) on a regular basis under medical supervision. Phototherapy is one of the safest and most costeffective therapies for psoriasis and may be the only therapy option for certain subsets of psoriasis patients, i.e. children, pregnant women and immuno-suppressed patients. Both treatments work by penetrating the skin and slowing the growth of affected skin cells.

Why is CMS proposing this change? Where CMS found reimbursements to be higher in a  non-facility setting than in a facility setting, non-facility practice expense relative value units (RVUs) were reduced toalign with the Medicare's Hospital Outpatient Prospective Payment System (OPPS) payment for the same service.4

In other words, non-facility RVUs were capped at the OPPS level.5 RVUs are a calculation of physician work, practice expense, and malpractice expense. For services with no work RVUs (including phototherapy), CMS is proposing to compare the total non-facility PFS payment to the OPPS payment rates directly since no PFS payment is made for these services when furnished in the facility setting.


CMS suggests that the unaligned payments are not the result of appropriate payment differentials between the services furnished in different settings. Rather, they believe it is due to anomalies in the data they use under the PFS and in the application of the resource-based practice expense (PE) methodology to the particular services.6


Flaw with CMS rationale: The rationale underlying the phototherapy cuts in the CY 2014 Physician Fee Schedule is fundamentally flawed because the OPPS and ambulatory surgical center (ASC) fee setting does not evaluate the costs of the resources that are used to provide services and fails to recognize the extent to which a hospital or ASC may offset the costs of providing these services. OPPS and ASC fees are grouped into Ambulatory Payment Classifications (APCs) which are intended to cover the costs of providing services in those settings, but which may actually pay more or less than the costs incurred. Hospitals and ASCs are able to offset the underpaid services with those that pay more than costs that are incurred, something physicians are unable to do. There is no evidence that the fees OPPS or ASC fee schedule accurately reflect the cost of providing services, and they certainly do not reflect the cost of providing services in the physician’s office. Using APCs incomplete fees to value services that are performed 90.6% and 91.8% of  the time respectively (for codes 96910 and 96912) in a physician’s office is not in the best interest of Medicare beneficiaries.


Likely Patient Impact: There is already a shortage of phototherapy units in the country, and these cuts would likely lead to additional closures of phototherapy units and decreased availability of these treatments, adversely affecting millions of patients. Should this treatment option disappear, many patients would be forced to go without treatment or transition to a systemic therapy that includes biologics, which can cost more than 10 times the expense of phototherapy treatments. (Phototherapy costs approximately $2,000- $3,000 a year.)

NPI: Troubleshooting Rejections

Denial Reason, Reason/Remark Code(s)

N257: Information missing/invalid in Item 33 - Missing/incomplete/invalid billing provider supplier primary identifier

N290: Information missing/invalid in Item 24J - Missing/incomplete/invalid rendering provider primary identifier


Resolution/Resources:

Each NPI must match one Provider Transaction Access Number (PTAN) on the NPI crosswalk file.

Step 1: If you contract with a billing service, find out if they have had communication with Palmetto GBA about NPI claim rejections. They may have important information that will help you resolve these claims.

Step 2: Verify the information on file with the NPI Enumerator. Call the NPI Enumerator at 800-465-3203 or access their website external link  to verify your information.


Pay special attention to the following fields in your NPPES record:

Each 'sole proprietor' should have an Individual (Entity Type 1) NPI and not an Organization (Entity Type 2) NPI
List your correct, current Medicare PTAN in the 'Other Provider Identifiers' section

If your NPI matches a PTAN that you no longer use (e.g., an old practice location), obtain and complete a new CMS-855 application and mail it to Palmetto GBA. Applications are available from the CMS 855 form external link  from the Enrollment Application Finder tool. We will be happy to assist you if you have questions about how to complete the application.


Step 3: If you are continuing to receive claim rejections after verifying information on file with the NPI Enumerator, verify the information you have on file with Palmetto GBA. Changes in this information require that you complete a new CMS-855 application.


Pay special attention to the Taxpayer Identification Number (TIN), which is used to report your income to the IRS on Form 1099


Consider consolidating multiple PTANs into a single number to ensure a one-to-one NPI to PTAN match. You may collapse PTANs that are assigned to additional locations only if the additional locations are all assigned the same TIN and are within the same pricing locality. More information about consolidating multiple PTANs is available in the CMS MLN Matters article MM5906
Step 4: Be aware of NPIs submitted for ordering/referring providers and attending/operating/other/service facilities

NPI numbers submitted in these fields must be valid. You may access the CMS NPI Registry to obtain these numbers.

CPT Code Description

Non-Reimbursable

99026 Hospital mandated on call service; in-hospital, each hour

99027 Hospital mandated on call service; out-of-hospital, each hour

99360 Standby service, requiring prolonged physician attendance, each 30 minutes (e.g., operative standby, standby for frozen section, for cesarean/high risk delivery, for monitoring EEG)


QUESTIONS AND ANSWERS

1 Q: If a pediatrician or other physician is requested by the delivering physician to attend at delivery and provide services to stabilize a newborn, are those services considered standby services?

A: No. If a physician is requested by the delivering physician to attend at delivery and to provide stabilization of a newborn, the physician may bill for those direct face-to-face services provided to the newborn using CPT code 99464.


APPLICABLE LINES OF BUSINESS/PRODUCTS

This policy applies to Oxford Commercial plan membership.

This reimbursement policy applies to services reported using the UB-04 claim form, the 1500 Health Insurance Claim Form (a/k/a CMS-1500), or their electronic equivalents or their successor forms. This policy applies to all network and non-network providers, including hospitals, ambulatory surgical centers, physicians and other qualified healthcare professionals, including, but not limited to, non-network authorized and percent of charge contract physicians and other qualified health care professionals.



OVERVIEW

This reimbursement policy addresses reimbursement for standby services and hospital mandated on-call services.



Current Procedural Terminology

Per Current Procedural Terminology (CPT) definition, code 99360 is used to report physician or other qualified health care professional standby services that are requested by another individual that involves prolonged attendance without direct (face-to-face) patient contact. Care or services may not be provided to other patients during this period.

This code is not used to report time spent proctoring another individual. It is also not used if the period of standby ends with the performance of a procedure subject to a surgical package by the individual who was on standby.




REIMBURSEMENT GUIDELINES

Centers for Medicare and Medicaid Services

The Centers for Medicare and Medicaid Services (CMS) does not reimburse for physician standby services. These services are considered by CMS to be included in the payment to a facility as part of providing quality care and are not separately reimbursable.

Standby Services

In accordance with CMS, Oxford does not reimburse physician or other qualified health care professional standby services submitted with CPT code 99360. If a specific service is directly rendered to the patient by the standby physician or other qualified health care professional (i.e., tissue examination of frozen section biopsy), the service or procedure would be reported under the appropriate CPT code (i.e., 88331).


Mandated Hospital On-Call Service 

Oxford does not reimburse for hospital mandated on-call services billed under CPT codes 99026 and 99027 because they do not involve direct patient contact.

REIMBURSEMENT GUIDELINES

Time Span Codes

Oxford will reimburse a CPT or HCPCS Level II code that specifies a time period for which it should be reported (e.g., weekly, monthly), once during that time period. The time period is based on sourcing from the AMA or CMS including: the CPT or HCPCS code description, CPT book parentheticals and other coding guidance in the CPT book, other AMA publications or CMS publications.

For example: Within the CPT book, the code description for CPT code 95250 states, “Ambulatory continuous glucose monitoring of interstitial tissue fluid via subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording”. In addition to that code description, there is also a parenthetical that provides further instructions with regard to the frequency the code can be reported. The parenthetical states, “Do not report 95250 more than once per month”. Oxford will reimburse CPT Code 95250 only once per month for the same member, for services provided by the Same Group Physician and/or Other Health Care Professional. In order to consider reimbursement for these services that may be repeated following a month with fewer than 31 days, Oxford may allow reimbursement of monthly time span codes when these codes are reported with dates of service at least 28 days apart.

CPT coding guidelines specify for physicians or other qualified health care professionals to select the name of the procedure or service that accurately identifies the services performed.



End-Stage Renal Disease Services (ESRD) 90951-90962 

CPT codes 90951-90962 are grouped by age of the patient and the number of face-to-face physician or other qualified health care professional visits provided per month (i.e., 1, 2-3, or 4 or more). Oxford will reimburse the single most comprehensive outpatient ESRD code submitted per age category (i.e., under 2 years of age, 2-11 years of age, 11- 19 years of age, and 20 years of age and older) once per month. This aligns with CPT coding guidance which states to report the age-specific ESRD codes should be reported once per month for all physician or other health care professional face-to-face outpatient services.




Time Span Comprehensive and Component Codes

When related Time Span Codes which share a common portion of a code description are both reported during the same time span period by the Same Group Physicians and/or Other Health Care Professional for the same patient, the code with the most comprehensive description is the reimbursable service. The other code is considered inclusive and is not a separately reimbursable service. No modifiers will override this denial. The following example illustrates how the CPT book lists code 93268 first as it is the comprehensive code. CPT codes 93270, 93271, and 93272 are indented and each share a common component of their code description with CPT code 93268.


When CPT code 93270, 93271, or 93272 are reported with CPT 93268 during the same 30 day period by the Same Group Physician and/or Other Health Care Professional for the same patient, only CPT code 93268 is the reimbursable service.

The Time Span Comprehensive and Component Codes list includes applicable comprehensive and related component Time Span Codes.

DEFINITIONS Calendar Month: Oxford defines Calendar Month as the time span referring to an individually named month of the year, (e.g., January, February) and includes codes with Calendar Month in their description.



Same Group Physician and/or Other Health Care Professional: All physicians and/or other health care professionals of the same group reporting the same Federal Tax Identification number.

Time Span Code: A CPT or HCPCS code that specifies a time period for which it should be reported (e.g., weekly, monthly).



APPLICABLE CODES

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or noncovered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies may apply.


CPT Code Description

93268

External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; includes transmission, physician review and interpretation 93270 Recording (includes connection, recording, and disconnection) 93271 Transmission and analysis

93272 Review and interpretation by a physician or other qualified health care professional CPT® is a registered trademark of the American Medical Association QUESTIONS AND ANSWERS



1 Q: How does Oxford determine the “time span” for codes with a description of calendar month, per month or monthly?

A: The date of service (DOS) is the reference point for determining the frequency of code submission and subsequent reimbursement during that period. See the examples below: Calendar Month

CPT code 94005 (home ventilator management care plan oversight of a patient (patient not present) in home, domiciliary or rest home (e.g., assisted living) requiring review of status, review of laboratories and other studies and revision of orders and respiratory care plan (as appropriate), within a calendar month, 30 minutes or more) is submitted March 13. The Same Group Physician and/or Other Health Care Professional reports this code for the same patient on April 5. Both codes are considered eligible for reimbursement as a Time Span Code because the service was provided in a different Calendar Month.


Per Month/or Monthly

HCPCS code A4595 [Electrical stimulator supplies, 2 lead, per month, (e.g. tens, nmes)] is submitted August 31. The Same Group Physician and/or Other Health Care Professional reports this code for the same patient on September 30. Both codes are considered eligible for reimbursement.

In order to consider reimbursement for services that may be repeated following a month with fewer than 31 days, Oxford may allow reimbursement of monthly time span codes when these codes are reported with dates of service at least 28 days apart.

2 Q: Does Oxford recognize modifiers, (e.g., 59, 76), through the Time Span Codes Policy to allow reimbursement for additional submissions of a code within the designated time span?

A: No. Reimbursement for codes included in the Time Span Codes Policy is based on the time span parameter specified in the code description, CPT book parentheticals and/or other coding guidance from the AMA or CMS.

36005 Injection procedure for extremity venography 0.95 $328 $50

36010 Introduction of catheter, superior or inferior vena cava 2.18 $492 $114

36011 Selective catheter placement, venous system; first order branch 3.14 $842 $164

36012 Second order, or more selective, branch 3.51 $868 $181


Insertion 33282 Implantation of patient-activated cardiac event recorder Removal 33284 Removal of an implantable, patient-activated cardiac event recorder

Revenue Code Description

Home Health Care Visits

0642 Home iv therapy services-iv site care, central line

0643 Home iv therapy services- IV start/change, peripheral line

0644 Home iv therapy services-non-routine nursing, peripheral line

0645 Home iv therapy services-training patient/caregiver, central line

0646 Home iv therapy services-training, disabled patient, central line

0647 Home iv therapy services-training, patient/caregiver, peripheral line

0648 Home iv therapy services-training, disabled patient, peripheral line

0649 Home iv therapy services-other iv therapy services

Therapy by a Home Health Care Agency/Facility

Coding Clarification: These codes apply to the Home Health Care Visit limit with the following Bill Type:

• 032x : Home health - Home Health Services under a plan of treatment

* 034x : Home health - Home Health Services not under a plan of treatment

0420 Physical therapy-general

0421 Physical therapy-visit charge

0422 Physical therapy-hourly charge

0423 Physical therapy-group rate

0424 Physical therapy-evaluation or reevaluation

0429 Physical therapy-other physical therapy

0430 Occupational therapy-general

0431 Occupational therapy-visit charge

0432 Occupational therapy-hourly charge

0433 Occupational therapy-group rate

0434 Occupational therapy-evaluation or reevaluation

0439 Occupational therapy-other occupational therapy

0440 Speech therapy-language pathology-general

0441 Speech therapy-language pathology-visit charge

0442 Speech therapy-language pathology-hourly charge

0443 Speech therapy-language pathology-group rate

0444 Speech therapy-language pathology-evaluation or reevaluation

0449 Speech therapy-language pathology-other speech-language pathology


Hemophilia

For coverage of assisted administration of clotting factors and coagulant blood products, refer to the policy titled Assisted Administration of Clotting Factors and Coagulant Blood Products. For coverage of clotting factor and coagulant blood products, refer to the policy titled Clotting Factors and Coagulant Blood Products.

Essential Health Benefits for Individual and Small Group

For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit plan document to determine benefit coverage.



COVERAGE RATIONALE

Indications for Coverage

The services being requested must meet all of the following:

** Be ordered and directed by a treating practitioner or specialist (M.D., D.O., P.A. or N.P); and

** The care must be delivered or supervised by a licensed professional in order to obtain a specified medical outcome; and

** Services must be skilled care in nature (refer to the policy titled Skilled Care and Custodial Care Services and the Definitions section below); and

** Services must be intermittent and part time (typically provided for less than 4 hours per day; refer to the member specific benefit plan document for intermittent definitions, if provided); and

** Services are provided in the home in lieu of skilled care in another setting (such as but not limited to a nursing facility, acute inpatient rehabilitation or a hospital); and

** Services must be clinically appropriate and not more costly than an alternative health services; and

** A written treatment plan must be submitted with the request for specific services and supplies’ periodic review of the written treatment plan may be required for continued Skilled Care needs and progress toward goals; and

** Services are not provided for the comfort and convenience of the member or the member’s family; and

** Services are not custodial care in nature. Medical Necessity Plans

Use the criteria above where applicable.

Additional Information

** Medical supplies and medications that are used in conjunction with a home health care visit are covered as part of
that visit. Some examples are, but not limited to, surgical dressing, catheters, syringes, irrigation devices.

Reimbursement for home health care visits and supplies are contractually determined. ** Eligible physical, occupational and speech therapy received in the home from a Home Health Agency is covered under the Home Health Care section of the member’s certificate of coverage and/or summary of benefits. The Home Health Care section only applies to services that are rendered by a Home Health Agency.