June 2004 Medicare Bulletin - Tennessee Insert
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Table of Contents
- Bexxar® (Tositumomab and Iodine 131 - Tositumomab)-LCD Article
- Bexxar® (Tositumomab and Iodine 131 - Tositumomab)Comment Summary
- Bexxar® (Tositumomab and Iodine 131 - Tositumomab) - L15591 - LCD
- Chest X-Ray (L6097) LMRP Revision
- End Dialstolic Pneumatic Compression Therapy (L13853) - LCD Article
- End Dialstolic Pneumatic Compression Therapy (L13853) - LCD
- Off Label Use of Chemotherapy Drugs for Cancer - LCD Article
- Off Label Use of Chemotherapy Drugs for Cancer - LCD
- Omalizumab (Xolair®) (L15329) - LCD Article
- Omalizumab (Xolair®) Comment Summary
- Omalizumab (Xolair®) (L15329) - LCD
- Spinal Cord Stimulators (L6282) LMRP
- Tennessee Medical Association Workshop
- Tennessee Health Professional Shortage Areas (HPSAs)
Tennessee Medical Association’s 24th Annual Insurance Workshops ”Making Hard Jobs Easier”
Sites |
Dates |
|
|---|---|---|
| Kingsport | September 21 | |
| Knoxville | September 22 & 23 | |
| Chattanooga | September 29 | |
| Cookeville | September 30 | |
| Jackson | October 12 | |
| Memphis | October 13 | |
| Nashville | October 26 & 27 | |
Presentations By: |
||
CIGNA Government Services |
Better Health Plan |
|
Bureau of TennCare |
Health Spring |
|
BlueCare/TNCare Select |
Victory Health Plan |
|
TRICARE/PGBA |
OmniCare Health Plan |
|
AdvoCare/TBH |
TLC Family Care Healthplan |
|
John Deere Health Plan |
Frost-Arnett Company |
|
Cariten/PHP |
The Horne Group |
For More Information Contact Karen Moore @ 615.312.9026 or Karen.moore@hcpag.com
Sponsored By |
Coordinated By |
|---|---|
| TN Medical Association | The Horne Group |
| 2301 21st Ave. S. | 1801 West End Ave. #800 |
| Nashville, TN. 37212 | Nashville, TN. 37203 |
| 615.385.2100 | 615.312.9050 |
(04-0933)
TopBexxar® (Tositumomab and Iodine131-Tositumomab) (L15591) - LCD
Bexxar® (Tositumomab and Iodine131-Tositumomab) (L15591) - LCD
(04-0784)
Bexxar® (Tositumomab and Iodine131 – Tositumomab) - LCD Article
Article Publication Date
12/01/2003
Article Beginning Effective Date
12/01/2003
Article Text
This article is to describe the method of payment for tositumomab (“cold” antibody) and I-131 labeled tositumomab (the radiopharmaceutical) when these agents are covered by the Medicare program. Currently, this regimen is approved only for treatment of patients with CD20+ follicular, non-Hodgkin’s lymphoma with and without transformation, whose disease is refractory to rituximab, and has relapsed following chemotherapy. The Bexxar therapeutic regimen is administered in two separate steps: the dosimetric and the therapeutic. Each step consists of a sequential infusion of tositumomab followed by I-131 tositumomab.
The dosimetric step involves radionuclide scanning to determine the biodistribution of tositumomab. The procedure encompasses administration of radiolabeled tositumomab and whole body radionuclide scanning following administration of I-131 tositumomab. The purpose of the dosimetric dose is to determine individual pharmacokinetics and amount of radioactivity to be delivered in the therapeutic dose. Determining appropriate biodistribution involves making a qualitative comparison of isotope uptake in several organ systems between three scans taken over the seven days following the dosimetric administration of I-131 tositumomab. The therapeutic step is administered 7 – 14 days after the dosimetric step.
When Bexxar is administered in the hospital out-patient setting it is paid under the Hospital OPPS. Please see the intermediary instructions for appropriate billing in those situations. Whether given in the hospital setting or ambulatory setting, the 78990, 78999 and 78800 – 78803 codes are NOT to be used. Similarly, codes 79900, 79100, 79400 and 77750 are NOT to be used when billing for Bexxar treatment.
If a physician furnishes Bexxar to a Medicare beneficiary outside the hospital setting, the physician should bill using the following HCPCS codes:
A. Dosimetric/Diagnostic regimen
A4641 –Supply of radiopharmaceutical diagnostic imaging agent, NOC
78804 (new code, effective 01/01/2004) – Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); whole body, requiring two or more days imagingB. Therapeutic regimen
A9699 – Supply of radiopharmaceutical therapeutic imaging agent, NOC
79403 – (new code effective 01/01/2004) Radiopharmaceutical therapy, radiolabeled monoclonal antibody by intravenous infusionC. Dosimetric Calculation
77300 should be used to bill for the dosimetric calculation. Only one 77300 will be paid per complete treatment course.
The radiopharmaceutical and the “cold” tositumomab will be paid at invoice, and the claim, if filed electronically, should have the “actual invoice cost/ invoice on file” stated in the narrative field. If filing on paper, the invoice should accompany the claim, with the statement “invoice attached” in Box 19.
The claims for the Dosimetric/Diagnostic step should be submitted on one claim, the Therapeutic on another. Only one 78804 will be paid per complete treatment course of Bexxar, regardless of the number of scans performed.
Services furnished after 7/1/03 but before 1/1/04 should be billed as above, but with G0273 instead of 78804, and G0274 instead of 79403.
Related Documents
LCD(s)
L15591 - Bexxar® (Tositumomab and Iodine131-Tositumomab)
(04-0854)
Bexxar® (Tositumomab and Iodine 131 - Tositumomab) Comment Summary
Policy Title: Bexxar® (Tositumomab and Iodine131 – Tositumomab)
Open Forum Presentation: February 17, 2004
CAC Meeting Presentation: February 24, 2004
End of Comment Period: April 5, 2004
Start of Notice Period: April 22, 2004
Policy Effective Date: June 7, 2004
Comment: FDA approval stipulates that patients with previous bone marrow transplant are not eligible for this regimen.
Response: The FDA approval letter of June 27, 2003 reads: “Tositumomab and Iodine I 131 Tositumomab, administered as a therapeutic regimen, are indicated for the treatment of patients with CD20 positive, follicular, non-Hodgkin’s lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.”
Comment: Please clarify how reimbursement for the two tositumomab doses necessary prior to the dosimetric and therapeutic doses.
Response: Under A4641 we will pay for the “cold” and “hot” isotope and for any administration that is not a component of the scan. Under A9699, we will pay for the “cold” and “hot” isotope and any applicable administration fee that is not included in CPT code 79403. This comment and response are not part of the medically reasonable and necessary statement, but are being inserted for completeness.
(04-0854)
Chest X-Ray (L6097) - LMRP Revision
Chest X-Ray (L6097) - LMRP Revision
End-Diastolic Pneumatic Compression Therapy (L13853) - LCD
End-Diastolic Pneumatic Compression Therapy (L13853) - LCD
End-Diastolic Pneumatic Compression Therapy - LCD Article
End-diastolic pneumatic compression therapy is a non-surgical treatment designed to compress portions of the leg in the end phase of the cardiac cycle, enhancing blood flow to the extremity. Therapeutic effects from this treatment regimen is thought to decrease venous pressure, interstital fluid pressure, vasoconstriction, and viscosity, and increase cardiac output, pulse pressure, and fibrinolysis in the treated extremity. This therapy is used for the treatment of non-healing ulcers, which result from, or are compounded by poor blood flow to and from the extremity. Additionally, this therapy may be useful in treating claudication pain and chronic lymphedema.
The HCPCS/CPT codes may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.
End-diastolic pneumatic compression therapy should be reported using CPT Code 99199, unlisted services and procedures. Providers who qualify for the exception to bill on paper and elect to do so, should insert “end-diastolic pneumatic compression therapy” in Field 19 of Form CMS 1500. Electronic billers should enter “end-diastolic pneumatic compression therapy” in the NTE segment (notes and comment segment). This is the electronic equivalent for Field 19 of Form CMS 1500 in HIPAA compliant transactions.
CPT Code 99199 will represent all end-diastolic compression therapy provided to a patient per day. This code ( 99199) also encompasses the evaluation prior to, during, and post treatment for the date of service the therapy is rendered. Therefore, only (1) unit of service per day may be reported for this therapy, regardless of the time involved.
When billing for diabetic ulcers, please use an ICD-9 code from the series 250.70 - 250.83 as primary (line item) diagnosis and an ICD-9 code from the series 707.10 - 707.19 as secondary diagnosis, as applicable.
Since this therapy is synchronized to end-diastolic function, can affect cardiac output, and can cause significant diuresis, it is to be performed only by or under the direct supervision of a physician. Direct supervision in the office environment does not mean that the physician must be present in the same room with his or her aide. However, the physician must be present in the office suite and immediately available to provide assistance and direction throughout the time the aide is performing the services.
Services performed in the home setting should be billed to the DMERC regional carrier and are subject to DMERC’s policy for coverage.
Coverage Topic
Category Undefined
Coding Information
Bill Type Codes
999x
Not Applicable
Revenue Codes
99999
Not Applicable
CPT/HCPCS Codes
99199 UNLISTED SPECIAL SERVICE, PROCEDURE OR REPORT
Coding Table Information
There is no Coding Table Information for this policy.
Other Information
Other Comments
This Article was converted from an LMRP on 04/12/2004
Related Documents
LCD(s)
L13853 - End-Diastolic Pneumatic Compression Therapy
(04-0872)
Off Label Use of Chemotherapy Drugs for Cancer (L13684) - LCD
Off Label Use of Chemotherapy Drugs for Cancer (L13684) - LCD
Off Label Use of Chemotherapy Drugs for Cancer - LCD Article
The CMS Manual System, Pub 100-2, Medicare Benefit Policy (basic coverage rules), Chapter 15, Section 50 (http://www.cms.hhs.gov/manuals/) defines coverage for drugs and biologicals. Generally, these are covered only if all of the following requirements are met:- They meet the definition of drugs or biologicals (see CMS Manual System, Pub 100-2, Medicare Benefit Policy (basic coverage rules), Chapter 15, Section 50.1(http://www.cms.hhs.gov/manuals/);
- They are of the type that are not usually self- administered by the patient (see CMS Manual System, Pub 100-2, Medicare Benefit Policy (basic coverage rules), Chapter 15, Section 50.2
(http://www.cms.hhs.gov/manuals/); - They meet all the general requirements for coverage of items as incident to a physician’s services (see CMS Manual System, Pub 100-2, Medicare Benefit Policy (basic coverage rules), Chapter 15, Sections 50.3 (http://www.cms.hhs.gov/manuals/);
- They are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice (see CMS Manual System, Pub 100-2, Medicare Benefit Policy (basic coverage rules), Chapter 15, Section 50.4.1 (http://www.cms.hhs.gov/manuals/);
- They are not excluded as immunizations (see CMS Manual System, Pub 100-2, Medicare Benefit Policy (basic coverage rules), Chapter 15, Section 50.4.4 (http://www.cms.hhs.gov/manuals/); and
- They have not been determined by the FDA to be less than effective. (CMS Manual System, Pub 100-2, Medicare Benefit Policy (basic coverage rules), Chapter 15, Section 50.4.1 (http://www.cms.hhs.gov/manuals/)
FDA approval is one of the main criteria for Medicare coverage. An unlabeled use of a drug is a use that is not included as an indication on the drug’s label as approved by the FDA. In CMS Manual System, Pub 100-2, Medicare Benefit Policy (basic coverage rules), Chapter 15, Section 50.4.2. CMS provides instructions about the unlabeled use of anti-cancer drugs.
LCD# L13684 (Contractor’s Determination Number 2003-06-02)describes the criteria that must be met to establish medical reasonableness and necessity for the off-label use of an anti-cancer drug upon initial claim examination and on further review.
When coding for the unlabeled treatment in situations as described in the LCD under #3, #4, #5, and #6 in “Indications and Limitations of Coverage and/or Medical Necessity,” append modifier -KX to the HCPCS code for the chemotherapeutic agent and use as the line item diagnosis the ICD-9 code for carcinoma of unknown primary site in scenario #3 and an ICD-9 code for the organ in which the tumor originates in scenarios #4, #5, and #6.
For example, for carcinoma of the renal pelvis originating from transitional cell carcinoma (treated as bladder cancer), the line item diagnosis should be ICD-9 189.1 (malignant neoplasm of renal pelvis) and not carcinoma of the bladder.
For these situations, the provider must document in the medical record the supportive evidence and rationale for the choice of therapy. The -KX modifier serves as attestation that this specific required documentation is on file.
Please note that these coding guidelines are specific to the situations as described under #3, #4, #5, and #6 in the “Indications and Limitations of Coverage and/or Medical Necessity” of this policy. They do not apply to any other unlabeled uses of chemotherapy drugs than the ones listed here.
All “Incident To” rules apply.
Medicare does not provide pre-authorization for any services or procedures, and the Carrier Medical Director (CMD) cannot overturn an initial denial. However, denials may be appealed.
The appeal is an examination conducted by personnel independent of the Medical Review Department. As a result, no one outside the Appeals Department can conduct the initial appeal determination or influence it. This is to keep the appeal proceedings unbiased and distinctly apart from the initial decision. The regulations require that a specific request for an appeal be submitted to the Appeals Department. Form CMS 1964 can be used. It can be accessed at http://www.cms.hhs.gov/forms/cms1964.pdf. Providers may prefer to express their disagreement in a signed written statement. It must contain the following information:
- Beneficiary name;
- Medicare health insurance claim (HIC) number;
- Name and address of provider/supplier of item/ service;
- Date of initial determination (date of remittance for which the claim first denied);
- Date(s) of service for which the initial determination was issued (dates must be reported in a manner that comports with the Medicare claims filing instructions; ranges of dates are acceptable only if a range of dates is properly reportable on the Medicare claim form);
- Which item(s), if any, and/or service(s) are at issue in the appeal; and
- Signature of the appellant.
A copy of the Medicare Remittance Notice for the denied services should be attached.
Coverage Topic
Chemotherapy (Inpatient)
Chemotherapy (Outpatient)
Coding Information
Bill Type Codes
999x
Not Applicable
Revenue Codes
99999
Not Applicable
CPT/HCPCS Codes
XX000
Not Applicable
Coding Table Information
There is no Coding Table Information for this policy.
Other Information
Other Comments
This Article was converted from an LMRP on 04/12/2004
Related Documents
LCD(s)
L13684 - Off Label Use of Chemotherapy Drugs for Cancer
(04-0889)
Omalizumab (Xolair®) (L15329) - LCD
Omalizumab (Xolair®) (L15329) - LCD
Omalizumab (Xolair®) - LCD Article
Omalizumab (Xolair®) - Coding Guidelines and Reasons for Denial
Coding Guidelines:
- Omalizumab should be reported using the HCPCS procedure code J3490.
- Providers who qualify for the exception to bill on paper and elect to do so, should insert a narrative description of the agent and the dose administered in Field 19 of Form CMS 1500. Electronic billers should enter a narrative description of the agent and the dose administered in the NTE segment (notes and comment segment). This is the electronic equivalent for Field 19 of Form CMS 1500 in HIPAA compliant transactions.
- This service must be performed in an office for Part B reimbursement. It cannot be billed to the Part B Carrier when provided in POS 21 and 22.
- The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.
Reasons for Denial:
- Medicare will not cover this drug if the patient does not meet all of the criteria listed in the “Indications and Limitations of Coverage” section of this carrier’s corresponding Local Coverage Determination (LCD) on this service.
- Part B reimbursement for omalizumab cannot be made when it is self-administered.
- IgE levels are not reimbursable during treatment and up to one year after discontinuation of omalizumab due to total IgE levels remaining elevated throughout this time.
- Dose changes without significant weight changes will result in denials.
- Continued use of omalizumab in the face of worsening symptoms, or lack of improvement of the daytime and nighttime symptoms will result in denials.
- Use of omalizumab is reimbursable only to Specialty 03 (Allergy/Immunology), Specialty 29 (Pulmonary Disease) or other physicians (MD/DO) who have special expertise in evaluation and treatment or asthma will be denied.
- In office monitoring after administration of omalizumab is considered part of the administration and not separately payable.
Coverage Topic
Doctor Office Visits
Prescription Drugs
Related Documents
LCD(s)
L15329 - Omalizumab (Xolair®)
(04-0856)
Omalizumab (Xolair®) - Comment Summary
Policy Title: Omalizumab (Xolair®)
Open Forum Presentation: February 17, 2004
CAC Meeting Presentation: February 24, 2004
End of Comment Period: April 4, 2004
Start of Notice Period: April 22, 2004
Policy Effective Date: June 7, 2004
Comment: The requirement to meet all criteria for moderate persistent asthma is too restrictive, because of seasonal variations, the fluctuation of symptoms, and exacerbations.
Response: After careful reevaluation, discussion with subject matter experts, and consideration, we feel that all the criteria of the definition must be met before initiating treatment with Omalizumab (Xolair®). The definition has been adopted from the National Heart, Lung and Blood Institute; it was not created for the purpose of this policy. This new biological has potentially serious adverse reactions, such as anaphylaxis, and only partially known long term effects that may include neoplasms.
Comment: Difficulty to document pulmonary functions below a certain level. Due to the reversibility of asthma, the treating physician may not see patients at the point when their pulmonary functions are below these levels. The patient may be on medication that influences these results.
Response: To meet the required definition, the reduction of lung function has to be only minimal. However, it is an objective criterion, whereas, the symptom based criteria are only subjective. We feel that it has to be documented before starting this therapy that has the potential for significant adverse reactions or long term side effects.
Comment: It is too restrictive to require that only allergists and pulmonologists can use this drug.
Response: The policy statement will be expanded to state: “The use of this drug will be limited to Specialty 03 (Allergy/Immunology) and Specialty 29 (Pulmonary Disease), or other physicians (MD/DO) who have special expertise in evaluation and treatment or asthma.”
Comment: There are more perennial aeroallergens that the ones listed.
Response: The listing of specific perennial aeroallergens will be omitted.
Comment: The criterion that asthma must be present for one year before a patient can be classified as being asthmatic and payment for omalizumab can be made is arbitrary and without justification.
Response: This is a new biological with potentially serious adverse reactions and only partially known long term effects. It appears reasonable to take a conservative approach.
Comment: There is no data to suggest that a therapeutic response will occur within three months, and a 6 months trial is more likely to fully determine those patients who will benefit, although, there is no firm data to support this.
Response: If there has been no change in the daytime or nighttime symptoms within the first three months of therapy, it is reasonable to consider discontinuation of the therapy, as stated in the policy. There is no substantial data to suggest that patients who do not respond after three month will do so after six months.
Comment: Why must ‘’maximum doses’’ of corticosteroids be given prior to starting omalizumab? Recent evidence suggests that maximum doses of inhaled steroids add no more benefit than moderate doses in regard to patient response, while such higher doses only increase toxicity.
Response: The policy provides a definition of inadequate control with inhaled steroids. There is no reference to “maximum doses.” It is realized that different patients will respond differently to inhaled steroids at various stages of their illness. Inhaled steroids and their titration are the standard of care for the treatment of asthma. It is felt that before using this new biological with its potentially serious adverse reactions and only partially known long term effects, it is reasonable to utilize all existing time tested modalities.
Comment: Is it appropriate to use the CPT code 90782 and the J code for the drug?
Response: The MPFSDB Status Code indicator for CPT code 90782 is “T,” with the following definition: “There are RVU’s for these services, but they are only paid if there are no other services payable under the physician fee schedule billed on the same date by the same provider. If any other services payable under the physician fee schedule are billed under the same date by the same provider, these services are bundled into the service(s) for which payment is made.” In other words, when an E/M service that is higher than 99211 is billed with 90782, the latter will deny. If CPT 99211 is billed with CPT 90782, CPT 99211 will deny, as its work RVUs are included in CPT 90782. Additionally, an E/M code cannot be billed solely for the purpose of the injection. It must be a separately identifiable service, in which case modifier -25 would apply. If an E/M code is billed with modifier -25, CPT code 90782 is not separately payable. This comment and response are not part of the medically reasonable and necessary statement, but are being inserted for completeness.
(04-0854)
Spinal Cord Stimulators (L6282) - LMRP
Spinal Cord Stimulators (L6282) - LMRP
Tennessee Health Professional Shortage Areas (HPSAs)
Designated Geographic Areas
|
1 Classified as a HPSA, effective March 1, 2001.
2 No longer classified as a HPSA, effective January 1, 2001.
3 No longer classified as a HPSA, effective July 1, 2001.
4 Classified as a HPSA, effective July 1, 2001.
5 Classified as a HPSA, effective September 1, 2001.
6 No longer classified as a HPSA, effective February 1, 2001.
7 Classified as a HPSA, effective December 1, 2001.
8 Classified as a HPSA, effective March 1, 2002.
9 No longer classified as a HPSA, effective March 1, 2002.
10 Classified as a HPSA, effective April 1, 2002.
11 Classified as a HPSA, effective June 1, 2002.
12 Classified as a HPSA, effective February 1, 2004.
(04-1008)
