November 2003 Part B Medicare Bulletin
Table of Contents
- 2004 Healthcare Common Procedure Coding System (HCPCS) - Annual Update Reminder
- Are Your Claims Being Rejected?
- CMS Posts National Correct Coding Initiative (NCCI) Edits on Internet
- Comprehensive Error Rate Testing (CERT) and the Importance to Submit
Requested Information - Home Health Patients – Definition of Homebound
- Inappropriate Use of Home Health Certification and Recertification Codes
- Incentive Payments to Physicians for Professional Services Furnished
in Health
Professional Shortage Areas (HPSAs) - Influenza Vaccine – New Diagnosis Code
- Injectable Anti-Emetics for Chemotherapy Related Nausea and Vomiting
- Kyphoplasty Update
- Levocarnitine for Use in the Treatment of Carnitine Deficiency in ESRD Patients
- Medicare Home Health Benefit – Overview
- Medicare Program Integrity Manual (PIM)
- National Coverage Determination Implantable Automatic Defibrillators
- New Online CMS Manual System
- Overpayment Refunds
- Payment Amount for the Influenza Vaccine
- Payment Policy When More Than One Patient is Onboard an Ambulance
- Program Memorandum on Written Statements
of Intent (SOI) to Claim
Medicare Benefits
Are Your Claims Being Rejected?
Medicare providers are encouraged to bill their claims electronically, but in cases where a paper claim needs to be filed, the CMS-1500 claim form must be completed accurately to expedite processing. Instructions for completing the CMS-1500 claim form can be found on the CMS Web site. The following items from the CMS-1500 claim form have been identified as the most common reason(s) for claim rejection(s).
1. Item 1A
The Beneficiary Medicare Number must be entered in Item 1a of the CMS-1500 claim form exactly as it appears on the red, white, and blue Medicare card.
2. Item 2
Beneficiary Name should be entered in Item 2 of the CMS-1500 claim form exactly as it appears on the red, white, and blue Medicare card.
3. Item 9/Item 13 Medigap
These items should only be filled out if the following is met:
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Provider must be a participating provider.
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The beneficiary has a Medigap company as their Medicare supplement.
For Medigap crossover the claim must have the following information:
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The provider must give indication of Medigap in 9a by giving policy or group number proceeded by MEDIGAP, MG, or MGAP.
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A 9-digit PAYERID (ZIP-OCNA) number; if no PAYERID number enter Medigap Company name and complete address.
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Claim must have beneficiary signature or indication of signature on file in Item 13
4. Item 11 Other Insurance Primary to Medicare
This item must be completed. By completing this item, the physician/supplier acknowledges having made a good faith effort to determine whether Medicare is primary or secondary.
If there is an insurance primary to Medicare enter the insured’s policy or group number in Item 11 and proceed to 11a-11c. In Item 11c entered the appropriate information, insurance name/company name.
If there is no insurance primary to Medicare, “none” should be entered into this field. Entering information other than the “primary insurance” or “none” can cause your claim(s) to be denied.
5. Item 12 Patient Signature
A patient signature authorizes release of medical information necessary to process a claim. It also authorizes payment of benefits to the provider of service or supplier, when the provider of service or suppler accepts assignment.
Patient’s signature is a required field and must be filled out with date signed. If signature/date is left blank the claim will be rejected.
A signature can be submitted by:
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Patient’s signature
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If a beneficiary is illiterate or physically handicapped they can sign by using “X,” however a witness must enter his/her name and address by the mark.
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The beneficiary can sign an agreement to be retained on file at the provider’s office. Claim must indicate signature on file.
6. Item 24D Procedure code/modifiers
This Item is for procedure code(s) and modifier(s). If procedure code(s) require additional information it must be placed in “Item 19” or “an attachment.” If more than two (2) modifiers are needed on a procedure code, modifier 99 must be appended to the procedure code and all modifiers indicated in Item 19. The information in item 19 must be referenced to the appropriate procedure code in Item 24d (Example line 1 99 = 26, 76, 59).
7. Items 24k/33 Provider Number/PIN
The Medicare provider number (PIN) of the physician who rendered the service should be entered into Item 24K of the CMS-1500 claim form or in Item 33.
This will reduce the risk of misdirected payments to the wrong provider.
Proper completion of the CMS-1500 claim form will help expedite the processing of your claim(s). When a claim/service is returned as unprocessable a new CMS-1500 claim form must be submitted
Remember, beginning October 16, 2003, all Medicare claims must be submitted electronically unless you meet the exception criteria. Additional information can be found at: www.cms.hhs.gov/HIPAAGenInfo/.
(04-0164)
Payment Policy When More Than One Patient is Onboard an Ambulance
Background
The final regulation to establish an ambulance fee schedule contained an additional provision that clarified the payment policy for pricing a single ambulance vehicle transport of a Medicare beneficiary where more than one patient is onboard the ambulance.
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When more than one patient is transported in an ambulance, the Medicare allowed charge for each beneficiary is a percentage of the allowed charge for a single beneficiary transport (the “allowed charge” for a single beneficiary transport is the lower of the submitted charge and the fee schedule amount for the service – which, during the fee schedule transition period, is a blended amount.) The applicable percentage is based on the total number of patients transported, including both Medicare beneficiaries and non-Medicare patients.
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This policy applies to both ground and air transports. For purposes of this PM, the term “ground transport” includes transports by water ambulance.
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If two patients are transported at the same time in one ambulance to the same destination, the adjusted payment allowance for each Medicare beneficiary would equal 75 percent of the single-patient allowed amount applicable to the level of service furnished a beneficiary, plus 50 percent of the total mileage payment allowance for the entire trip.
If three or more patients are transported at the same time in one ambulance to the same destination, the adjusted payment for each Medicare beneficiary would equal 60 percent of the single-patient allowed amount applicable to the level of service furnished that beneficiary plus a proportional mileage allowed amount, i.e., the total mileage allowed amount divided by the number of all the patients onboard. -
The fact that the level of medically necessary service among the patients may be different is not relevant to this payment policy. The percentage is applied to the allowed amount applicable to the level of service that is medically necessary for each beneficiary.
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If a multi-patient transport includes multiple destinations, then the Medicare allowed amount for mileage depends upon whether it is for an emergency versus non-emergency ground transport.
a. For an emergency ground transport, which includes BLS-E, ALS1-E, ALS2, and SCT, the mileage payment shall be based on the number of miles to the nearest appropriate facility for each patient, divided by the number of patients on board when the vehicle arrives at the facility. This formula applies cumulatively for beneficiaries who are the 2nd or 3rd patient to be delivered. Absent evidence to the contrary, carriers should assume that the sequence of deliveries was predicated on the medical needs of each patient.
b. For a non-emergency ground transport, which includes BLS and ALS1, the mileage payment shall be based on the number of miles from the point of pickup to the nearest appropriate facility for each beneficiary, divided by the number of beneficiaries on board when the vehicle arrives at the facility. This formula applies cumulatively for beneficiaries who are the 2nd or 3rd patient to be delivered. Mileage other than the mileage that would be incurred by transporting the beneficiary directly from the point of pick-up to the nearest appropriate facility is not covered. Thus, for non-emergency transports, the extra mileage that may be incurred by having multi-destinations shall not be taken into account.
c. For air transports the policy is the same as for emergency ground transports. -
If a Medicare beneficiary is furnished medically necessary supplies, and the supplier bills supplies separately, then the allowed amount of the supplies is not subject to an apportionment for multiple patients. The allowed amount for supplies should be determined in the same manner as if the beneficiary was the only patient onboard the vehicle.
Implementation
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Suppliers should use modifier “GM” to identify a multiple transport.
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Suppliers should submit documentation to specify the particulars of a multiple transport. The documentation must include the total number of patients transported in the vehicle at the same time and the health insurance claim numbers for each Medicare beneficiary.
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Suppliers should submit the charge applicable to the appropriate service rendered to each beneficiary and the total mileage for the trip.
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Suppliers should submit all associated Medicare claims for that multiple transport within a reasonable number of days of submitting the first claim.
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If there is only one Medicare beneficiary in the multiple patient transport, carriers will claims using the necessary information from the supplier’s documentation.
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If more than one Medicare beneficiary is transported in a multiple patient transport, the carrier will associate all ambulance claims for Medicare beneficiaries for the one transport.
[EM 2002-0985/CR 1945]
(04-0125)
CMS Posts National Correct Coding Initiative (NCCI) Edits on Internet
CMS developed the NCCI to promote national correct coding by physicians and other providers and to ensure appropriate payments for Medicare services. The coding policies developed are based on coding conventions defined in the American Medical Association’s CPT Current Procedural Terminology manual, national and local policies and edits, coding guidelines developed by national medical specialty societies, analysis of standard medical and surgical practice and review of current coding practice.
CMS has posted the latest version of the NCCI Edits to the CMS Web site at http://cms.hhs.gov/physicians/cciedits/default.asp. Providers with Internet access will no longer need to contact NTIS in order to obtain a copy of the correct coding edits.
To make the edits document user friendly, an excel spreadsheet was developed that allows users to sort by procedure code and by effective date. CMS has also added a “Find” feature with which users can search for a specific code. The edit files are indexed on the Web page by procedure code ranges for easy navigation. The Web page also includes links to documents that explain the edits: the NCCI Policy Manual for Part B Medicare Carriers, Medicare Carriers Manual, and the NCCI Question and Answer page. CMS will post the edits each quarter to coincide with the normal release of the latest version of the edits.
[EM 2003-0874]
(04-0096)
Comprehensive Error Rate Testing (CERT) and the Importance to Submit Requested Information
| Article Publication Date | 10/17/2003 |
| Article Beginning Effective Date | 10/22/2003 |
| Article Text | To assess and monitor the accuracy of medical payments, the Centers
for Medicare & Medicaid Services (CMS) has implemented a system known
as the Comprehensive Error Rate Testing (CERT). The program seeks to
identify patterns of payment errors in aggregate based on random sampling.
It is not aimed at reviewing individual providers and their practices.
The primary objectives are to determine if Medicare contractors – including
CIGNA Government Services -- are paying claims correctly, and to reduce the error
rate. The largest single type of error is lack of or insufficient documentation,
responsible for over 50 percent of all errors in North Carolina and Tennessee.
As a Medicare Program Safeguard Contractor (PSC) and independent auditor, AdvanceMed Corporation is sending out requests for supporting documentation on various claims, similar to the now discontinued routine pre-payment audits. AdvanceMed has statutory authority for soliciting this information. In accordance with Section 1833 of the Social Security Act, Medicare billing providers must provide claim attachments and medical records on request to support claims for Medicare Services. AdvanceMed acts in the capacity of a business associate of CMS with respect to the HIPAA Privacy Rule. Submitting this information is not in violation with the HIPAA Privacy Rule and does not require beneficiary authorization. In the interest of the reduction of the error rate and to minimize the bureaucratic burden on our providers, we are asking that physician offices comply with these requests and send in the claim attachments and medical records requested. It is important to reply, as the lack of a response counts as an error, will set off follow-up inquiries, and will ultimately lead to suspension of payment(s) or recoupment of funds. Please respond as soon as possible, but no later than in 45 days, to the address indicated in AdvanceMed's letter and include all necessary documentation to support each and every service (line item) of every claim on the pull-list provided by AdvanceMed. An error will be counted in the case of no response but also if the CERT Contractor deems the documentation received as not sufficient to make a review decision. Therefore, the more information - the better. Thank you very much for your cooperation. |
[EM 2003-0865/CR 2886]
(04-0097)
New Online CMS Manual System
Beginning October 1, 2003, CMS will transition from a paper-based manual system to a Web-based system. The process includes the streamlining, updating, and consolidating of CMS' various program instructions into an electronic Web-based manual system for all users. The new system is called the online CMS Manual System and is located at http://www.cms.hhs.gov/manuals.
The new online CMS Manual System will be organized by functional area (e.g., eligibility, entitlement, claims processing, benefit policy, program integrity). The functional orientation of the new manual will eliminate significant redundancy within the manuals and will streamline the updating process, thus making CMS program instructions available in a more timely and accessible fashion.
Specifically, the CMS Manual System will include the following functional areas:
- Pub. 100-01--Medicare General Information, Eligibility, and Entitlement
- Pub. 100-02--Medicare Benefit Policy
- Pub. 100-03--Medicare National Coverage Determinations
- Pub. 100-04--Medicare Claims Processing
- Pub. 100-05--Medicare Secondary Payer
- Pub. 100-06--Medicare Financial Management
- Pub. 100-07--Medicare State Operations
- Pub. 100-08--Medicare Program Integrity
- Pub. 100-09--Medicare Contractor Beneficiary and Provider Communications
- Pub. 100-10--Medicare Quality Improvement Organization
- Pub. 100-11—Reserved
- Pub. 100-12--State Medicaid
- Pub. 100-13--Medicaid State Children’s Health Insurance Program
- Pub. 100-14--Medicare End Stage Renal Disease Network Organization
- Pub. 100-15--Medicare State Buy-In
- Pub. 100-16--Medicare Managed Care
- Pub. 100-17--Medicare Business Partners Systems Security
- Pub. 100-18--Medicare Business Partners Security Oversight
- Pub. 100-19—Demonstrations
- Pub. 100-20--One-Time Notification
[EM 2003-0865/CR 2886]
(04-0097)
Payment Amount for the Influenza Vaccine
Effective September 1, 2003, the Medicare Part B payment allowances for CPT 90658 and CPT 90659 is $9.95. Annual Part B deductible and coinsurance amounts do not apply. All physicians, non-physician practitioners, and suppliers who administer the influenza virus vaccination must take assignment on the claim for the vaccine.
[EM 2003-0871/CR 2918]
(04-0091)
Influenza Vaccine – New Diagnosis Code
All Medicare institutional providers, Part B physicians, non-physician practitioners, and suppliers who administer the influenza virus vaccine must use the new diagnosis code, ICD-9-CM V04.81, for claims with dates of service on and after October 1, 2003. However, there is a grace period until December 31, 2003, for all terminated ICD-9-CM codes.
If you have questions about the new diagnosis code, ICD-9-CM V04.81, for the influenza virus vaccine, please contact your appropriate carrier.
[EM 2003-0922; 2003-0884]
(04-0179, 04-0133, 04-0100)
2004 Healthcare Common Procedure Coding System (HCPCS) - Annual Update Reminder
The new HCPCS update is effective for dates of services on or after January 1, 2004. The 3-month grace period still applies to discontinued HCPCS codes. The grace period applies to claims received prior to April 1, 2004, which include 2003 discontinued codes for dates of service January 1, 2004, through March 31, 2003. We will accept both 2003 discontinued codes and valid 2004 codes from physicians, suppliers, and providers during the January-March 2004 grace period.
[EM 2003-0863/CR 2896]
(04-0090)
Medicare Home Health Benefit – Overview
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Article Beginning Effective Date |
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Article Text |
Medicare Home Health Benefit |
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Coverage Topic |
Home Health Care |
(04-0123)
Inappropriate Use of Home Health Certification and Recertification Codes
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Article Text |
The Centers for Medicare and Medicaid Services requires ongoing
data analysis by CIGNA Government Services to determine whether patterns of
claims submission and payment indicate potential billing problems
exist within our state. |
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Coverage Topic |
Home Health Care |
(04-0122)
Home Health Patients – Definition of Homebound
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Article Beginning Effective Date |
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Article Text |
As there can be a variety of reasons a person
is homebound, the following is being published to establish guidelines
to qualify for coverage of home health services. To be homebound
means that the patient cannot leave home without excessive effort
such as but not limited to requiring the aid of supportive devices
(i.e. crutches, canes, wheelchairs, and walkers), the use of special
transportation, the assistance of another person, or if he or she
has a condition which is such that leaving his or her home is medically
contraindicated. Absences from home must be infrequent, or of short
duration, or to get medical attention. Any absence of an individual
from the home attributable to the need to receive health care treatment,
including regular absences for the purpose of participating in therapeutic,
psychosocial, or medical treatment in an adult day-care program that
is licensed or certified by a state, or accredited, to furnish adult
day-care services in the state shall not disqualify an individual
from being considered to be confined to his home. It is expected
that in most instances absences from the home which occur will be
for the purpose of receiving medical treatment. However, occasional
absences from the home for non-medical purposes, e.g., an occasional
trip to the barber, attending a religious service, a walk around
the block, or a drive would not necessitate a finding that the individual
is not homebound so long as they are undertaken on an infrequent
basis or are of relatively short duration and do not indicate that
the patient has the capacity to obtain the health care provided outside
rather than in the home. Generally, if a beneficiary is absent from
the home an average of 16 or more hours per month for non-medical
reasons then the homebound criterion would not be met.
A beneficiary may be homebound and still not qualify for home health. If he or she requires more than 35 hours per week of combined skilled nursing and home health aide care then the intermittent care criterion would not be met. This individual would require a more monitored setting such as a skilled nursing facility. |
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Coverage Topic |
Home Health Care |
(04-0124)
National Coverage Determination — Implantable Automatic Defibrillators
This provider education article discusses the background of the National Coverage Determination (NCD) to expand coverage of implantable automatic defibrillators for services rendered on or after October 1, 2003, coverage guidelines, billing instructions for providers who render services to managed care patients, and billing instructions for providers who render services to fee-for-service patients.
Background
The NCD will be effective on October 1, 2003, to expand coverage of implantable automatic defibrillators for Medicare managed care and fee-for-service patients. Providers will be reimbursed for services provided to managed care patients for implantable automatic defibrillators that fall under the expanded coverage indications effective October 1, 2003, according to the NCD on a fee-for-service basis until capitation rates are adjusted to account for this expanded coverage.
Coverage Guidelines
The following service is covered when rendered on or after July 1, 1991:
- Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient or reversible cause;
The following services are covered when rendered on or after July 1, 1999:
- Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause;
- Documented familial or inherited indications with a high risk of life-threatening VT, such as long QT syndrome or hypertropic cardiomyopathy;
As stated in the NCD, the following indications will be covered when rendered on or after October 1, 2003:
- Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction £ 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 4 weeks prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.);
- Documented prior MI and a measured left ventricular ejection fraction ≤ 0.30
and a QRS duration of > 120 milliseconds. Patients must not have:
- New York Heart Association classification IV;
- Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
- Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months;
- Had an enzyme-positive MI within past month;
- Clinical symptoms or findings that would make them a candidate for coronary revascularization; or
- Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.
As stated in the NCD, effective October 1, 2003, the following additional coverage guidelines apply:
- All patients considered for implantation of a defibrillator must not have irreversible brain damage, disease, or dysfunction that precludes the ability to give informed consent;
- MIs must be documented by elevated cardiac enzymes or Q-waves on an electrocardiogram. Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography; and
- All other indications remain noncovered except in Category B IDE clinical trials (60 CFR 48417) or as a routine cost in clinical trials defined under CIM 30-1.
NOTE: Refer to Coverage Issues Manual, Section 35-85 (revisions effective October 1, 2003).
Billing Instructions for Providers Who Render Services to Managed Care Patients
The following instructions apply to providers who render expanded implantable automatic defibrillator services to managed care patients:
- Providers are encouraged not to submit claims for services rendered on or after October 1, 2003, because Medicare will not be able to process the claims until January 5, 2004.
- Physicians must use modifier KZ (new coverage not implemented by managed care) when billing for services rendered on and after October 1, 2003.
- Providers billing fiscal intermediaries on or after October 1, 2003, must use condition code 78 (payment for coverage not implemented by HMO).
- Providers who are paid under the Outpatient Prospective Payment System (OPPS) must bill all services related to this expanded coverage on one claim and for the same date of service, using condition code 78.
- Providers billing carriers and providers who are paid under the OPPS must split the bills if they overlap September 2003 and October 2003.
- Patients who receive these services must pay any applicable coinsurance amounts.
- For services rendered to managed care patients whose indications fall outside this expanded coverage, providers must not bill using condition code 78 or modifier KZ.
Billing Instructions for Providers Who Render Services to Fee-for-Service Patients
The following instructions apply to providers who render expanded implantable automatic defibrillator services to fee-for-service patients:
- Claims for these services cannot be billed using modifier KZ, condition code 78, or for services outside of this expanded coverage.
Procedure Codes
NOTE: The new G codes listed below are payable under OPPS effective October 1, 2003. These new G codes are NOT payable under the Medicare Physician Fee Schedule and, therefore, should not be billed to Medicare carriers.
- G0297
- G0298
- G0299
- G0300
- ICD-9-CM Procedure Code 37.94 (for 11X TOBs)
NOTE: The physician should bill for the appropriate service from the range of CPT codes below. These services should be billed to the appropriate Medicare carrier for payment.
- 33240
- 33241
- 33243
- 33244
- 33245
- 33246
- 33249
[EM 2003-0823/CR 2880; EM 2003-0878/CR 2922]
(04-0156)
Injectable Anti-Emetics for Chemotherapy Related Nausea and Vomiting
| Article Publication Date | 11/01/2003 |
| Article Beginning Effective Date | 11/01/2003 |
| Article Text | Chemotherapy related nausea and vomiting can be present beyond the day on which the chemotherapy is administered. In these situations, intravenous anti-emetics may be covered subject to the rules of medical necessity. When billing for injectable anti-emetics administered on a date succeeding the chemotherapy, providers must append modifier -KX to the applicable Level II HCPCS code. This attests to documentation in the medical record that the injectable anti-emetic was given for nausea and vomiting related to chemotherapy. Please use ICD-9 codes 787.01, 787.02, or 787.03, as applicable. |
(04-0081)
Kyphoplasty Update
| Article Publication Date | 10/17/2003 |
| Article Beginning Effective Date | 11/01/2003 |
| Article Text | Kyphoplasty is a surgical procedure that involves the cannulation of
the vertebral body, followed by the insertion of an inflatable balloon
tamp. Once inflated, the balloon tamp restores some height to the vertebral
body, while creating a cavity that is filled with bone cement.
In the absence of a National Policy and a Local Medical Review Policy, this carrier will be determining coverage case by case, based on Medicare's medical necessity and reasonableness criteria (similar to percutaneous vertebroplasty). Providers should submit claims with CPT code 22899 (unlisted procedure, spine) and state "Kyphoplasty" in Item 19 of Form CMS-1500 form or in its electronic equivalent. Radiological supervision and interpretation may be billed with CPT codes 76012 or 76013, as applicable. The surgical fee for this service is all-inclusive. Casting or the removal of bone to create a cavity for the insertion of the tamp, sometimes submitted as a bone biopsy, are not separately billable. The Global Period is ten days. Effective with November 1, 2003, the allowable amounts for this procedure will be increased to the following levels: Thoracic: $628.19 Please note that this treatment should only be used for vertebral compression fractures that meet the definition of medical necessity for percutaneous vertebroplasty and the coverage provisions as discussed in the Local Medical Review Policies of the respective states. Medicare coverage is based on both the FDA indications and the medical necessity for each vertebral body treated. The patient's medical record should reflect the indication for the procedure and contain a complete operative report. |
(04-0173)
Levocarnitine for Use in the Treatment of Carnitine Deficiency in ESRD Patients
This Program Memorandum (PM) contains payment instructions for intravenous levocarnitine for End Stage Renal Disease (ESRD) patients received on or after January 1, 2003.
Carnitine is a naturally occurring substance that functions in the transport of long-chain fatty acids for energy production by the body. Deficiency can occur due to a congenital defect in synthesis or utilization, or from dialysis. The causes of carnitine deficiency in hemodialysis patients include dialytic loss, reduced renal synthesis and reduced dietary intake.
Intravenous levocarnitine will only be covered for those ESRD patients who have been on dialysis for a minimum of 3 months for one of the following indications.
Patients must have documented carnitine deficiency, defined as a plasma free carnitine level<40 micromol/L (determined by a professionally accepted method as recognized in current literature), along with signs and symptoms of:
- Erythropoietin–resistant anemia (persistent hematocrit <30 percent with treatment) that has not responded to standard erythropoietin dosage (that which is considered clinically appropriate to treat the particular patient) with iron replacement, and for which other causes have been investigated and adequately treated, or
- Hypotension on hemodialysis that interferes with delivery of the intended dialysis despite application of usual measures deemed appropriate (e.g., fluid management). Such episodes of hypotension must have occurred during at least 2 dialysis treatments in a 30-day period.
Continued use of levocarnitine will not be covered if improvement has not been demonstrated within 6 months of initiation of treatment. All other indications for levocarnitine are non-covered in the ESRD population.
For a patient currently receiving intravenous levocarnitine, Medicare will cover continued treatment if:
- Levocarnitine has been administered to treat erythropoietin-resistent anemia (persistent hematocrit <30 percent with treatment) that has not responded to standard erythropoietin dosage (that which is considered clinically appropriate to treat the particular patient) with iron replacement, and for which other causes have been investigated and adequately treated, or hypotension on hemodialysis that interferes with delivery of the intended dialysis despite application of usual measures deemed appropriate (e.g., fluid management) and such episodes of hypotension occur during at least 2 dialysis treatments in a 30-day period; and
- The patient’s medical record documents a pre-dialysis plasma free carnitine level <40 micromol/L prior to the initiation of treatment; or
- The treating physician certifies (documents in the medical record) that in his/her judgment, if treatment with levocarnitine is discontinued, the patient’s pre-dialysis carnitine level would fall below 40 micromol/L and the patient would have recurrent erythropoietin-resistant-anemia or intradialytic hypotension.
[EM 2003-0810/CR 2554]
(04-0068)
Program Memorandum on Written Statements of Intent (SOI) to Claim Medicare Benefits
This Program Memorandum (PM) clarifies CMS’s policy on SOI to claim Medicare Part A or Part B benefits (SOI). This PM also provides specific guidance with respect to existing requirements in the regulations and supersedes (1) the last two paragraphs of §3004.A. of the Medicare Carriers Manual (MCM), Part 3, and (2) §3312.2 of the Medicare Intermediary Manual (MIM), Part 3.
Purpose of a Statement of Intent
The purpose of a SOI is to extend the timely filing period for the submission of an initial claim. A SOI, by itself, does not constitute a claim, but rather is used as a placeholder for filing a timely and proper claim. Medicare regulations at 42 CFR §§424.32 and at 424.44 require that Medicare claims be filed on Medicare designated claim forms pursuant to Medicare instructions by the end of the year following the year in which the service/s are furnished (services furnished in the last three (3) months of a calendar year are deemed to be furnished in the subsequent year). The timely filing period to file a specific Medicare claim may be extended when a valid SOI, with respect to that claim, is furnished to the appropriate Medicare carrier or intermediary (i.e., the one that will be responsible for processing the claim), or regional s residence within the timely office (RO) serving the area of the beneficiary filing period. (If a RO receives a SOI, it should date stamp the SOI and forward it to the appropriate Medicare contractor.)
A SOI to claim Medicare benefits must be postmarked on or before, or received by the appropriate RO or contractor, no later than the last day of the timely filing period that pertains to the service/s covered by the SOI. (See §3305.3 of the MIM.) If someone wishes to simultaneously submit more than one SOI to a RO, then he or she must sort them by Medicare contractor before submitting them. If a SOI contains the necessary information for some services, but not for others, then the SOI will be accepted only for those services for which the necessary information has been submitted.
After a valid SOI has been filed, a completed claim that meets the requirements of 42 CFR §424.32(a), §§3005-3005.4 of the MCM, and §§3605.2-3605.3 of the MIM, must be submitted to the appropriate Medicare contractor within six (6) months after the month in which the contractor notifies the party who submitted the SOI that a claim may be filed, or by the end of the applicable timely filing period, whichever is later. (The month in which the contractor notifies the party is determined by the date of the contractor’s notification letter, unless the recipient of the notice can establish by a preponderance of the evidence that the notice was sent on a materially different date. Also, “party” and “parties” are used herein in their generic sense, and are not meant to imply that an individual or entity that submits a SOI to file has standing to file a claim or pursue an appeal of a denied claim.) In order to ensure that a filed claim, which purportedly has been protected by a previously submitted SOI (and, which would be untimely if not so protected), does in fact relate back to the SOI, a SOI must be for an “identified beneficiary” and for “specified services.” (See 42 CFR §424.45(b).)
NOTE: The filing of an invalid SOI does not extend the timely filing period, so that if a party submits an invalid SOI prior to the end of the timely filing period, and the contractor or the RO does not discover the invalidity and alert the submitter of the invalidity until shortly before, or even after the timely filing period has expired, the party may not correct or resubmit the SOI after the timely filing period has expired. In this regard, a party that submits an invalid SOI bears the full risk that he or she may be unable to resubmit a valid SOI within the applicable timely filing period.
Medicare contractors are not required to develop a claim under the SOI procedures. All claims for services must meet Medicare’s timely filing requirements. (See 42 CFR §424.44.) Timely filing requirements are further discussed in §3004 of the MCM and in §§3307 - 3312.5 of the MIM.
Who Can Submit Statements of Intent
Only the following parties may submit a SOI to claim Medicare benefits:
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Providers, as defined in 42 CFR §400.202, and parties to whom they may assign their payment per 42 CFR §424.73, for items or services they have furnished or are entitled to bill Medicare.
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Suppliers, as defined in 42 CFR §400.202, and parties to whom they can reassign payment per 42 CFR §424.80, for items or services they have furnished or are entitled to bill Medicare.
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Medicaid State agencies and parties authorized to act on behalf of Medicaid State agencies, with respect to items and services rendered to dually eligible beneficiaries.
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Beneficiaries and their authorized representatives, but only where the SOI relates to (1) a claim for services furnished by a nonparticipating hospital that has elected not to claim payment for emergency services, or (2) a claim for services for which a physician or other supplier, or proper resignee, was required to file a claim under §1848(g)(4) of the Act but has not done so.
Contents of a Valid Statement of Intent
A SOI must be signed, and the person signing must indicate the capacity in which he or she is signing (e.g., beneficiary or beneficiary’s authorized representative, provider, supplier, Medicaid State agency official, or party authorized to act on behalf of the Medicaid State agency).
For a SOI to be considered valid, it must be submitted to the appropriate contractor, and if a provider or supplier (or the party to whom payment can be assigned), or Medicaid State agency (or a party authorized to act on its behalf) submits a SOI, then the following information must be submitted with the SOI:
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Beneficiary name;
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Medicare Health Insurance Claim (HIC) number;
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Name, address, and Medicare billing number of provider/physician/supplier at time of service;
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Dates of service for which a specific claim will be filed (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); and,
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Applicable revenue, DRG, CPT, HCPCS or other applicable code, and appropriate modifiers for each service. (Codes must be reported in a manner consistent with the reporting of the codes on the Medicare claim form. Diagnosis codes by themselves are not acceptable.)
In order for a SOI that is submitted to a RO to be valid, the SOI must include all of the above information and must also include the correct name and address of the Medicare contractor that will be responsible for processing the subsequent claim or claims.
If a beneficiary or authorized representative submits a SOI, it must be submitted to the appropriate contractor and must include all of the information listed below.
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Beneficiary name;
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Medicare Health Insurance Claim (HIC) number;
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Name, address, and if available, the Medicare billing number of the provider/physician/supplier at time of service;
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Date(s) of service for which a specific claim will be filed (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); and.
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Item(s) or service(s) received.
In order for a SOI that is submitted to a RO by a beneficiary or a beneficiary’s authorized representative to be valid, it must include the information listed above and must also include the name and address of the Medicare contractor that will be responsible for processing the subsequent claim or claims.
Submitters may obtain the name and address of the appropriate Medicare contractor (i.e., Medicare carrier or fiscal intermediary) at the following Web site: http://www.medicare.gov/Contacts/Home.asp.
[EM 2003-0383/CR 1050]
(04-0159)
Medicare Program Integrity Manual (PIM)
The Medicare Program Integrity Manual (PIM) is the Centers for Medicare & Medicaid Services (CMS) manual that replaced instructions previously in various other contractor and provider manuals. The manual consolidates program integrity instructions from the Medicare Carriers Manual (MCM), the Medicare Intermediary Manual (MIM), and the provider manuals into a single electronic manual.
The Initial Issuance of the PIM was released by CMS on May 30, 2000. CMS does not publish hard copies of the manual. It is only available online at www.cms.gov/manuals/PIM.
You can access CMS Transmittals regarding PIM revisions at the Program Integrity Manual Archive page on the CMS Web site.
| Transmittal Number | Release Date | Summary of Revision | Effective/Implementation Date |
| 50 | 09/26/2003 | Revises Chapter 5, Section 7.4, Instructions for Processing Advance Determination of Medicare Coverage (ADMC) Requests, instructions to DMERCs to review medical documentation as well as the beneficiary claims history when processing ADMC requests. | October 10, 2003 |
| 49 | 09/26/2003 | Revises Chapter 3, Section 4.2.C, Denial Notices, to change the use of remittance advice code N109 from mandatory to contractor's discretion. | October 10, 2003 |
| 48 | 09/12/2003 | Deletes the instruction that an item denied as not meeting the beneit category is not appealable by the supplier. | October 1, 2003 |
| 45 | 07/25/2003 | Revises the Chapter 7, Section 7 requirement that FMR activity reports and bulletins should be sent to CMS central office. FMR reports should only be sent to regional offices. The effective date for this revision is May 1, 2003 and the implementation date is August 8, 2003. | Effective - 05/02/2003 Implementation - August 8, 2003 |
[EM 2003-0895/CR 2873; EM 2003-0893/CR 2866; EM 2003-0869/CR 2872; EM 2003-0708/CR 2693]
(04-0199, 04-0153, 04-0152, 04-0092)

