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December 2003 Part B Medicare Bulletin

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Artificial Hearts and Related Devices

(Rev 1, 10-17-03)

A ventricular assist device (VAD) or left ventricular assist device (LVAD) is used to assist a damaged or weakened heart in pumping blood.  These devices are used for support of blood circulation post-cardiotomy, as a bridge to a heart transplant, or as destination therapy.

A.      Covered Indications

1. Postcardiotomy (effective for services performed on or after October 18, 1993)

Post-cardiotomy is the period following open-heart surgery.  VADs used for support of blood circulation post-cardiotomy are covered only if they have received approval from the Food and Drug Administration (FDA) for that purpose, and the VADs are used according to the FDA- approved labeling instructions.

2. Bridge-to-Transplant (effective for services performed on or after January 22, 1996)

VADs used for bridge-to-transplant are covered only if they have received approval from the FDA for that purpose, and the VADs are used according to the FDA-approved labeling instructions.  All of the following criteria must be fulfilled in order for Medicare coverage to be provided for a VAD used as a bridge-to-transplant:

  1. The patient is approved and listed as a candidate for heart transplantation by a Medicare-approved heart transplant center; and,
  2. The implanting site, if different than the Medicare-approved transplant center, must receive written permission from the Medicare-approved heart transplant center under which the patient is listed prior to implantation of the VAD.

The Medicare-approved heart transplant center should make every reasonable effort to transplant patients on such devices as soon as medically reasonable.  Ideally, the Medicare-approved heart transplant centers should determine patient-specific timetables for transplantation, and should not maintain such patients on VADs if suitable hearts become available.

3. Destination Therapy (effective for services performed on or after October 1, 2003)

Destination therapy is for patients that require permanent mechanical cardiac support.  VADs used for destination therapy are covered only if they have received approval from the FDA for that purpose, and the device is used according to the FDA-approved labeling instructions.  VADs are covered for patients who have chronic end-stage heart failure (New York Heart Association Class IV end-stage left ventricular failure for at least 90 days with a life expectancy of less than 2 years), are not candidates for heart transplantation, and meet all of the following conditions:

  1. The patient's Class IV heart failure symptoms have failed to respond to optimal medical management, including dietary salt restriction, diuretics, digitalis, beta-blockers, and ACE inhibitors (if tolerated) for at least 60 of the last 90 days;
  2. The patient has a left ventricular ejection fraction (LVEF) < 25%;
  3. The patient has demonstrated functional limitation with a peak oxygen consumption of < 12 ml/kg/min; or the patient has a continued need for intravenous inotropic therapy owing to symptomatic hypotension, decreasing renal function, or worsening pulmonary congestion; and,
  4. The patient has the appropriate body size (³ 1.5 m²) to support the VAD implantation. 

In addition, the Centers for Medicare & Medicaid Services (CMS) has determined that VAD implantation as destination therapy is reasonable and necessary only when the procedure is performed in a Medicare-approved heart transplant facility that, between January 1, 2001, and September 30, 2003, implanted at least 15 VADs as a bridge-to-transplant or as destination therapy. These devices must have been approved by the FDA for destination therapy or as a bridge-to-transplant, or have been implanted as part of an FDA investigational device exemption (IDE) trial for one of these two indications.  VADs implanted for other investigational indications or for support of blood circulation post-cardiotomy do not satisfy the volume requirement for this purpose.  Since the relationship between volume and outcomes has not been well-established for VAD use, facilities that have minimal deficiencies in meeting this standard may apply and include a request for an exception based upon additional factors.  Some of the factors CMS will consider are geographic location of the center, number of destination procedures performed, and patient outcomes from VAD procedures completed. 

Also, this facility must be an active, continuous member of a national, audited registry that requires submission of health data on all VAD destination therapy patients from the date of implantation throughout the remainder of their lives.  This registry must have the ability to accommodate data related to any device approved by the FDA for destination therapy regardless of manufacturer.  The registry must also provide such routine reports as may be specified by CMS, and must have standards for data quality and timeliness of data submissions such that hospitals failing to meet them will be removed from membership.  CMS believes that the registry sponsored by the International Society for Heart and Lung Transplantation is an example of a registry that meets these characteristics.

Hospitals also must have in place staff and procedures that ensure that prospective VAD recipients receive all information necessary to assist them in giving appropriate informed consent for the procedure so that they and their families are fully aware of the aftercare requirements and potential limitations, as well as benefits, following VAD implantation. 

CMS plans to develop accreditation standards for facilities that implant VADs and, when implemented, VAD implantation will be considered reasonable and necessary only at accredited facilities.

A list of facilities eligible for Medicare reimbursement for VADs as destination therapy will be maintained on our website and available at www.cms.hhs.gov/coverage/lvadfacility.asp.  In order to be placed on this list, facilities must submit a letter to the Director, Coverage and Analysis Group, 7500 Security Blvd, Mailstop C1-09-06, Baltimore, MD 21244.  This letter must be received by CMS within 90 days of the issue date on this transmittal.   The letter must include the following information:

Facilities not meeting the minimal standards and requesting exception should, in addition to supplying the information above, include the factors that they deem critical in requesting the exception to the standards.  

CMS will review the information contained in the above letters.  When the review is complete, all necessary information is received, and criteria are met, CMS will include the name of the newly Medicare-approved facility on the CMS web site.  No reimbursement for destination therapy will be made for implantations performed before the date the facility is added to the CMS web site.  Each newly approved facility will also receive a formal letter from CMS stating the official approval date it was added to the list. 

B. Noncovered Indications (effective for services performed on or after May 19, 1986)

1. Artificial Heart

Since there is no authoritative evidence substantiating the safety and effectiveness of a VAD used as a replacement for the human heart, Medicare does not cover this device when used as an artificial heart.

2. All other indications for the use of VADs not otherwise listed remain noncovered, except in the context of Category B IDE clinical trials (42 CFR 405) or as a routine cost in clinical trials defined under section 310.1 of the NCD manual (old CIM 30-1).

(This NCD last reviewed October 2003)

[EM 2003-0937/CR2958]
(04-0211)

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Use of GY Modifier to Identify Clinical Diagnostic Laboratory Services that are Not Covered by Medicare

I.   General Information

A. Background:

In November 2002, Medicare implemented 23 national coverage determinations (NCDs) for clinical diagnostic laboratory services.  These NCDs are specific down to the ICD-9-CM code level and included lists of ICD-9-CM codes that are covered and those that are not covered by Medicare. The ICD-9-CM codes that are not covered by Medicare are codes that are excluded from coverage based on technical denials, such as routine screening services, rather than denial due to lack of medical necessity.  Laboratories are permitted to bill beneficiaries for services that are not covered by Medicare for reasons other than medical necessity without providing for an Advance Beneficiary Notice (ABN).

Medicare clinical diagnostic laboratory services are processed using a standardized laboratory edit module.  This edit module returns a message to the local contractor indicating whether the claim passed the NCDs coverage edits, is denied for diagnoses on the non-covered list, or is denied as not medically necessary.  Healthcare Common Procedure Coding System (HCPCS) coding provides for a modifier GY to be used to indicate an item or service that is statutorily excluded or does not meet the definition of any Medicare benefit.  At present, the laboratory edit module response is not affected by the use of this modifier.

B. Policy:

By January 1, 2004, the clinical diagnostic laboratory service edit module will be changed to consider the presence of the GY modifier in selecting the appropriate response for claims for clinical diagnostic laboratory services.  Use of the GY modifier will result in a not covered response from the edit module in all cases. Laboratories should append the GY modifier to the CPT procedure codes for any service where the appropriate diagnosis for that service is on the list of diagnoses that are not covered by Medicare.

[EM 2003-0951/CR 2933]
(04-0231)

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Annual Update of HCPCS Codes Used for Home Health Consolidated Billing Enforcement

I.   General Information

A.  Background: 

The CMS periodically updates the lists of Healthcare Common Procedure Coding System (HCPCS) codes that are subject to the consolidated billing provision of the Home Health Prospective Payment System (HH PPS).   With the exception of therapies performed by physicians, supplies incidental to physician services and supplies used in institutional settings, services appearing on this list which are submitted on claims to Medicare contractors will not be paid separately on dates when a beneficiary for whom such a service is being billed is in a home health episode (i.e., under a home health plan of care administered by a home health agency).  Medicare will only directly reimburse the primary home health agencies that have opened such episodes during the episode periods.  Therapies performed by physicians, supplies incidental to physician services and supplies used in institutional settings are not subject to HH consolidated billing.  Medicare contractors include fiscal intermediaries (FIs), carriers, and durable medical equipment regional carriers (DMERCs).

The HH consolidated billing code lists are updated annually, to reflect the annual changes to the HCPCS code set itself.   Additional updates may occur as frequently as quarterly in order to reflect the creation of temporary HCPCS codes (e.g., 'K' codes) throughout the calendar year.  The new coding identified in each update describes the same services that were used to determine the applicable HH PPS payment rates.  No additional services will be added by these updates; that is, new updates are required by changes to the coding system, not because the services subject to HH consolidated billing are being redefined.

This article provides the annual HH consolidated billing update for calendar year 2004.  Quarterly updates may follow in the course of calendar year 2004 if necessary. The specific changes are described in the attached code list.

The HH consolidated billing master code list is available at the following Internet address: cms.hhs.gov/providers/hhapps/#billing.

B.  Policy: 

Section 1842(b)(6) of the Social Security Act requires that payment for home health services provided under a home health plan of care is made to the home health agency.   This requirement is found in Medicare regulations at 42 CFR 409.100.

Code Changes for January 2004 Annual Update of Medicare HH Consolidated Billing Code Lists
New & Deleted Codes for HH CB
Code Description Action Replacement Code or Code Being Replaced
Non-Routine Supplies      
K0581 Ost pch clsd w barrier/filtr Delete Replacement Code: A4416
K0582 Ost pch w bar/bltinconv/fltr Delete Replacement Code: A4417
K0583 Ost pch clsd w/o bar w filtr Delete Replacement Code: A4418
K0584 Ost pch for bar w flange/flt Delete Replacement Code: A4419
K0585 Ost pch clsd for bar w lk fl Delete Replacement Code: A4420
K0586 Ost pch for bar w lk fl/fltr Delete Replacement Code: A4423
K0587 Ost pch drain w bar & filter Delete Replacement Code: A4424
K0588 Ost pch drain for barrier fl Delete Replacement Code: A4425
K0589 Ost pch drain 2 piece system Delete Replacement Code: A4426
K0590 Ost pch drain/barr lk flng/f Delete Replacement Code: A4427
K0591 Urine ost pouch w faucet/tap Delete Replacement Code: A4428
K0592 Urine ost pouch w bltinconv Delete Replacement Code: A4429
K0593 Ost urine pch w b/bltin conv Delete Replacement Code: A4430
K0594 Ost pch urine w barrier/tapv Delete Replacement Code: A4431
K0595 Os pch urine w bar/fange/tap Delete Replacement Code: A4432
K0596 Urine ost pch bar w lock fln Delete Replacement Code: A4433
K0597 Ost pch urine w lock flng/ft Delete Replacement Code: A4434
A4416 Ost pch clsd w barrier/filtr Add Replaces Code:  K0581
A4417 Ost pch w bar/bltinconv/fltr Add Replaces Code:  K0582
A4418 Ost pch clsd w/o bar w filtr Add Replaces Code:  K0583
A4419 Ost pch for bar w flange/flt Add Replaces Code:  K0584
A4420 Ost pch clsd for bar w lk fl Add Replaces Code:  K0585
A4423 Ost pch for bar w lk fl/fltr Add Replaces Code:  K0586
A4424 Ost pch drain w bar & filter Add Replaces Code:  K0587
A4425 Ost pch drain for barrier fl Add Replaces Code:  K0588
A4426 Ost pch drain 2 piece system Add Replaces Code:  K0589
A4427 Ost pch drain/barr lk flng/f Add Replaces Code:  K0590
A4428 Urine ost pouch w faucet/tap Add Replaces Code:  K0591
A4429 Urine ost pouch w bltinconv Add Replaces Code:  K0592
A4430 Ost urine pch w b/bltin conv Add Replaces Code:  K0593
A4431 Ost pch urine w barrier/tapv Add Replaces Code:  K0594
A4432 Os pch urine w bar/fange/tap Add Replaces Code:  K0595
A4433 Urine ost pch bar w lock fln Add Replaces Code:  K0596
A4434 Ost pch urine w lock flng/ft Add Replaces Code:  K0597
A4319 Sterile H2O irrigation solution Delete Replacement codes:  A4216 & A4217
A4323 Saline irrigation solution Delete Replacement codes:  A4216 & A4217
A4216 Sterile water/saline up to 10 ml Add Replaces A4319 & A4323
A4217 Sterile water/saline 500 ml Add Replaces A4319 & A4323
A4712 Sterile water injection, per 10 ml Delete  
A4622 Trachestomy or larngectomy Delete Replacement codes:  A7520, A7521, & A7522
A7520 Tracheostomy/larynectomy tube, non-cuffed Add Replaces code:  A4622
A7521 Tracheostomy/larynectomy tube, cuffed Add Replaces code:  A4622
A7522 Tracheostomy/larynectomy tube, stainless steel Add Replaces code:  A4622
A7523 Tracheostomy shower protector, each Add From or related to discontinued code, A4622 and/or A4623: Tracheostomy
A7524 Tracheostomy stent/stud/button, each Add From or related to discontinued code, A4622 and/or A4623: Tracheostomy
A4623 Trachestomy, inner cannula Add  
A7525 Tracheostomy mask, each Add Replaces code:  A4623
A7526 Tracheostomy tube collar/holder, each Add Replaces code:  A4623
K0621 Gauze, non-impreg packing strip Delete Replacement code:  A6407
A6407 Packing strips, non-impregnated, up to 2 inches, per lin yd Add Replaces:  K0621
A4248 Chlorhexidine containing anticeptic, 1 ml Add  
A4366 Ostomy vent, any type, each Add  
A6025 Gel sheet for dermal or epidermal application (e.g.  Silicone, hydrogel, other) Add  
A6441 Padding bandage, non-elastic, non-woven/non-knitted, width greater than or equal to three inches and less than five inches, per yard Add  
A6442 Conforming bandage, non-elastic, knitted/woven, non-sterile, width less than three inches, per yard Add  
A6443 Conforming bandage, non-elastic, knitted/woven, non-sterile, width greater than or equal to three inches and less than five inches, per yard Add  
A6444 Conforming bandage, non-elastic, knitted/woven, non-sterile, width greater than or equal to 5 inches, per yard Add  
A6445 Conforming bandage, non-elastic, knitted/woven, sterile, width less than three inches, per yard Add  
A6446 Conforming bandage, non-elastic, knitted/woven, sterile, width greater than or equal to three inches and less than five inches, per yard Add  
A6447 Conforming bandage, non-elastic, knitted/woven, sterile, width greater than or equal to five inches, per yard Add  
A6448 Light compression bandage, elastic, knitted/woven, width less than three inches, per yard Add  
A6449 Light compression bandage, elastic, knitted/woven, width greater than or equal to three inches and less than five inches, per yard Add  
A6450 Light compression bandage, elastic, knitted/woven, width greater than or equal to five inches, per yard Add  
A6451 Moderate compression bandage, elastic, knitted/woven, load resistance of 1.25 to 1.34 foot pounds at 50% maximum stretch, width greater than or equal to three inches and less than five inches, per yard Add  
A6452 High compression bandage, elastic, knitted/woven, load resistance greater than or equal to 1.35 foot pounds at 50% maximum stretch, width greater than or equal to three inches and less than five inches, per yard Add  
A6453 Self-adherent bandage, elastic, non-knitted/non-woven, width less than three inches, per yard Add  
A6454 Self-adherent bandage, elastic, non-knitted/non-woven, width greater than or equal to three inches and less than five inches, per yard Add  
A6455 Self-adherent bandage, elastic, non-knitted/non-woven, width greater than or equal to five inches, per yard Add  
A6456 Zinc paste impregnated bandage, non-elastic, knitted/woven, width greater than or equal to three inches and less than five inches, per yard Add  
Therapies
97755 Assistive technology assessment (eg, to restore, augment or compensate for existing function, optimize functional tasks and/or maximize environmental accessibility), direct one-on-one contact by provider, with written report, each 15 minutes Add  

[EM 2003-0936/CR 2831]
(04-0202)

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Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 1, 2004

I. General Information

A. Background:

This transmittal announces the changes that will be included in the January 2004 release of the edit module for clinical diagnostic laboratory services.  The NCDs for clinical diagnostic laboratory services were developed by the laboratory negotiated rulemaking committee and published as a final rule on November 23, 2001.  Nationally uniform software has been developed by Computer Science Corporation and incorporated in the shared systems so that laboratory claims subject to one of the 23 NCDs are processed uniformly throughout the nation effective January 1, 2003.  The laboratory edit module for the NCDs will be updated quarterly as necessary to reflect ministerial coding updates and substantive changes to the NCDs developed through the NCD process.

B.  Policy:

1. In accordance with the decision memorandum published on the coverage Internet site on September 17, 2003, (see http://cms.hhs.gov/mcd/viewdecisionmemo.asp?id=97) we are adding the following diagnosis codes to the list of ICD-9-CM Codes Covered by Medicare for the prothrombin time (PT) and fecal occult blood test (FOBT) NCDs:

2. In accordance with the decision memorandum published on the coverage Internet site on September 23, 2003, (see http://cms.hhs.gov/mcd/viewdecisionmemo.asp?id=93, we are deleting the following diagnosis codes from the list of ICD-9-CM Codes Covered by Medicare for PT and partial thromboplastin time (PTT) NCDs:

3. In Program Memorandum AB-03-104 (CR 2814) we announced the addition of diagnosis code 401.1, benign essential hypertension, to the list of covered diagnoses for lipid testing.  However, we neglected to announce the corresponding change to the narrative of the lipid NCD that authorizes this code.  By inclusion in this transmittal, we are announcing a change to the narrative of the lipid NCD that was included in the July 17, 2003 decision memorandum posted on the Internet at http://cms.hhs.gov/mcd/viewdecisionmemo.asp?id=94.  The third bullet listed in the lipid NCD indications section is amended to read:

"Any form of atherosclerotic disease, or any disease leading to the formation of atherosclerotic disease."

4. In Program Memorandum AB-03-104, we announced a number of ICD-9-CM codes that were deleted by the update in ICD-9-CM codes that became effective October 1, 2003.  We provided for a 90-day grace period for the provider and laboratory community to adapt to these changes.  Thus, while we announced the changes in CR 2814, we did not alter the software to deny claims when these codes were used.  However, the grace period expires with the January update of the software and the following ICD-9-CM codes will be denied: 282.4, 331.1, 348.3, 530.2, 600.0, 600.1, 600.2, 600.9, 767.1, 790.2, V04.8, V43.2, V53.9, V54.0, V65.1.

[2003-0950/CR2940]
(04-0200)

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Medical Review Frequently Asked Questions

The following represent a variety of questions the Medical Review department has received. CIGNA Government Services will address at least quarterly “Frequently Asked Questions” related to coverage and local medical review policy issues. The previous issue was posted on the Web site in July and published in the September 2003 Medicare Bulletin. Providers may submit questions to the Web site at http://www.cignamedicare.com/customer_service/disclaimer.html.

Website Inquiries

Q: Why wasn’t my inquiry answered?:
A:

Providers may submit inquiries to our website at the following link:

http://www.cignamedicare.com/medicare_dynamic/customer_service/index.html

Please note Medicare allows the carrier up to 45 days to respond. Depending on the volume and nature of the inquiries, it may take us up to that time frame to research and answer your question. So, it could be your question has not been answered yet rather than it hasn’t or won’t be answered. Additionally, we have responded to inquiries that are returned to us due to the wrong email address being entered by the inquirer. To ensure your inquiry is answered, please carefully enter your email address to which a response should be sent. Finally, please do not transmit any patient specific information such as a beneficiary’s HICN or the Medicare Provider Identification Number as this violates the HIPAA Privacy Rules.

Anesthesia: 01996 vs. 99231
Q: Which code should be used for postoperative pain management via an epidural catheter?
A:

Prior to 2003, all daily hospital management of epidural or subarachnoid continuous drug administration for postoperative pain management was billed using CPT code 01996. This code was revised in 2003 with the CPT manual instructing providers to bill for daily management with CPT code 01996 when the epidural catheter was placed for anesthesia and retained for postoperative pain management. CPT 2003 further instructs providers that daily management of an epidural that was not the method of anesthesia should be billed with an E/M code. Documentation should support the medical necessity and the level of the E&M code billed. The carrier will review claims for these services according to these guidelines for dates of services on or after the effective date of the change in this code. Unless this code and guidelines are further revised, providers should not continue to bill 01996 for daily management of an epidural that was not the method of anesthesia as was the practice for 2002.

HCPCS code G0275
Q: Has there been a change in the instructions regarding this code
A:

The July 2003 issue of the Medicare Bulletin instructs providers that HCPCS code G0275 should be used for select renal arteriography at the time of cardiac catheterization. CMS has since released an update of this code stating that it is for nonselective renal arteriography:

http://www.cms.hhs.gov/manuals/pm_trans/AB03119.pdf

Therefore, providers may bill services as this more recent CMS update instructs rather than as published in the July bulletin.

Wound Debridement
Q: What’s the difference between CPT codes 97601 and the CPT series 11040-11044?
A:

Providers should select the appropriate debridement code according to the type of tissue removed. Medical reviews have found that providers are confusing the depth of the wound versus the type of tissue removed when billing for debridement. An example of this would be the beneficiary having a wound extending to the muscular layer, but the provider debrides only infected subcutaneous tissue. This service would be billed with CPT code 11042.

CPT codes 11040 - 11044 clearly describe the type of layer removed. If the debridement service consists of the removal of less defined devitalized (necrotic) tissue that is superficially lining the wound bed, commonly referred to as slough, then the provider should bill 97601. Generally, the performance of services described by CPT codes 11040 - 11044 requires more complex surgical skills, whereas, CPT code 97601 consists of the elimination of superficial debris, for example with a high pressure waterjet, scissors, scalpel, and tweezers. If the wound was only cleansed of exudate/drainage/secretions, then this service does not meet the definition of debridement; and none of the above codes should be billed for such care.

To ensure the debridement codes you file are correct and supported in the medical record, the provider should refer to the local medical review policy for coverage and utilization guidelines (including covered diagnoses and frequency of treatment) as well as document:

• a specific/detailed description of the procedure and method used
• the size, depth(or grade) and appearance of the ulcer or wound
• the type of tissue or material removed

97601 is intended for a single session of wound care that may treat one or more sites, whereas, there could be multiple charges of CPT codes 11040-11044 (corresponding to the number of different wound sites) in a single encounter.

Related LMRPs:

Idaho- http://www.cignamedicare.com/partb/lmrp/id/cms_fu/2002-01.htm
North Carolina- http://www.cignamedicare.com/partb/lmrp/nc/cms_fu/2002-02.htm
Tennessee- http://www.cignamedicare.com/partb/lmrp/tn/cms_fu/2002-01-02.html

Cap on Outpatient Rehabilitation Services
Q: In regards to the annual therapy cap on Medicare patients effective September2003, can providers have a different fee schedule for their Medicare patients?
A:

Yes, as long as you do not charge anyone less than you would charge Medicare beneficiaries.

Related CMS Program Memorandum: http://cms.hhs.gov/manuals/pm_trans/AB03097.pdf

(04-0219)

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Medicare Deductible, Coinsurance, and Premium Rates for Calendar Year 2004 – Update

I.   General Information

A.  Background:  Beneficiaries who use covered Part A services may be subject to deductible and coinsurance requirements.  A beneficiary is responsible for an inpatient hospital deductible amount, which is deducted from the amount payable by the Medicare program to the hospital, for inpatient hospital services furnished in a spell of illness.  When a beneficiary receives such services for more than 60 days during a spell of illness, he or she is responsible for a coinsurance amount equal to one-fourth of the inpatient hospital deductible per-day for the 61st-90th day spent in the hospital.  An individual has 60 lifetime reserve days of coverage, which they may elect to use after the 90th day in a spell of illness.  The coinsurance amount for these days is equal to one-half of the inpatient hospital deductible.  A beneficiary is responsible for a coinsurance amount equal to one-eighth of the inpatient hospital deductible per day for the 21st through the 100th day of skilled nursing facility services furnished during a spell of illness.

Most individuals age 65 and older, and many disabled individuals under age 65, are insured for Health Insurance (HI) benefits without a premium payment.  The Social Security Act provides that certain aged and disabled persons who are not insured may voluntarily enroll, but are subject to the payment of a monthly premium.  Since 1994, voluntary enrollees may qualify for a reduced premium if they have 30-39 quarters of covered employment.  When voluntary enrollment takes place more than 12 months after a person’s initial enrollment period for HI benefits, the monthly premium increases by 10 percent.

Under Supplementary Medical Insurance (SMI), all enrollees are subject to a monthly premium.  Most SMI services are subject to an annual deductible and coinsurance (percent of costs that the enrollee must pay),which are set by statute.  When SMI enrollment takes place more than 12 months after a person’s initial enrollment period, the monthly premium increases by 10 percent for each full 12 month period during which the individual could have been enrolled, but was not.

Year 2004 Medicare Part A Deductible, Coinsurance, & Premium Amounts:

Deductible $876.00 per benefit period
Coinsurance $219.00 a day for days 61-90 in each period
  $438.00 a day for days 91-150 for each “Lifetime Reserve” day used
 

$109.50 a day in a Skilled Nursing Facility for days 21-100 in each benefit period
Premium $343.00 per month for those who must pay a premium
  $377.30 per month for those who must pay both a premium and a 10 percent increase
  $189.00 per month for those who have 30-39 quarters of coverage
  $207.90 per month for those who have 30-39 quarters of coverage and must pay a 10 percent increase

Year 2004 Medicare Part B Deductible, Coinsurance, & Premium Amounts:

Deductible $100.00 per year
Coinsurance 20 percent
Premium $66.60 per month

[EM 2003-0969/CR 2969]
(04-0230)

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Medicare Secondary Payer (MSP) Working Aged Provision – Clarification of Policy

CMS has added material to Pub. 100-05 - Medicare Secondary Payer as required by P.L. 104-199 to the MSP for the working aged provision. The effective date for the revision is April 1, 2004.

10.2 - Individuals Not Subject to the Limitation on Payment

(Rev. 2, 10-17-03)

A3-3491.3, B3-3336.1, B3-3336.9, HO- 253.4, SNF-336.4, HH-253.4

The Medicare secondary provision for working aged does not apply to:

[EM 2003-0942/CR 2252]
(04-0212)

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Modifiers for Transportation of Portable X-rays

Effective January 1, 2004, one of five new modifiers will be required on Medicare claims when reporting HCPCS code R0075 (Transportation of portable x-ray equipment and personnel to home or nursing home, per trip to facility or location, more than one patient seen).

Only a single transportation payment for each trip the portable x-ray supplier makes to a particular location (e.g., nursing home) is allowed. When reporting a transportation service and more than one Medicare patient is x-rayed at the same location, payment for R0075 is prorated among all patients receiving the services.

R0075 must be billed in conjunction with the CPT radiology codes (70000 series) and only when the x-ray equipment used was actually transported to the location where the x-ray was taken. R0075 would not apply to the x-ray equipment stored in the location where the x-ray was done (e.g., a nursing home) for use as needed.

Below are the definitions for each modifier that must be reported with R0075. Only one of these five modifiers can be reported with R0075.

UN Two patients served
UP Three patients served
UQ Four patients served
UR Five patients served
US Six patients or more served

[EM 2003-0954/CR 2856]
(04-0213)

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Non-physician Auxiliary Personnel – Billing

It has come to our attention that various types of “clinics” (such as Coumadin clinic, lipid clinic, and hypertension clinic) for patient care are developing, staffed by various types of non-physician personnel. Some of these are billing the Medicare program incorrectly for services rendered. The purpose of this article is to inform providers of those services as to which personnel can bill “incident to” and how they should bill for those services.

Certain types of non-physician providers – physician assistants, nurse practitioners, clinical nurse specialists, certified nurse midwives, clinical psychologists, clinical social workers, physical therapists, and occupational therapists – all have their own benefit categories, may obtain their own Medicare provider numbers, and may provide services without direct physician supervision and bill directly for those services. Other types of auxiliary personnel not specifically named above cannot obtain their own Medicare number and may not provide services without direct supervision by a physician. If any auxiliary personnel, whether having their own Medicare number or not, render services and bill as “incident to” services, they must meet the “incident to” provisions.

To be covered incident to the services of a physician, services and supplies must be:

• An integral, although incidental, part of the physician’s professional service
• Commonly rendered without charge or included in the physician’s bill
• Of a type that are commonly furnished in physician’s offices or clinics
• Furnished by the physician or by auxiliary personnel under the physician’s direct supervision

To be covered as “incident to” in the office/clinic setting (for all practical purposes, there is NO incident to provision in hospital, nursing facility or other setting), there must be “direct” supervision by a physician. This means the physician must be physically present in the office suite, not just in the building somewhere. If services are performed outside the office setting, e.g., in the home, they can only be covered “incident to” if there is direct physician supervision, i.e., the physician is also in the home at the time the services are rendered.

The fact that a state has licensed or certified certain providers to perform services and receive reimbursement for them does not automatically ensure that this will be a covered service by Medicare. The provider must still be in a benefit category defined by Medicare and be eligible to have a provider number for their services to be paid by Medicare (i.e., be one of the specifically named provider types in the second paragraph above).

When any evaluation and management services are furnished “incident to” a physician’s services by a non-physician employee of the physician (or the entity that employs the physician), and the employee is not a PA, NP, CNS, Nurse Midwife, Clinical Psychologist, or other provider named above, the physician should bill CPT code 99211 for the service. Physicians are not precluded from billing under the “incident to” provisions for services rendered by employees whose services cannot be paid directly by the Medicare program. Such employees may provide some appropriate services, but only the physician is permitted to bill Medicare. All the criteria for “incident to” must be met (see above).

Practices that have received over-payments because of incorrect billing should conduct self-audits and make voluntary refunds to the Medicare program. (References - See CMS Manual System, Pub. 100-2, Chapter 15, Section 15; CMS Manual System, Pub. 100-4, Chapter 12, Section 30.6. [http://www.cms.hhs.gov/manuals])

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Positron Emission Tomography (PET) Scans

Section 50-36, Positron Emission Tomography (PET) Scans, is revised to specify that we have expanded coverage for: Noninvasive imaging of the perfusion of the heart using FDA-approved Ammonia N-13 tracer; and for: Restaging of recurrent or residual thyroid cancers of follicular cell origin that have been previously treated by thyroidectomy and radioiodine ablation and have a serum thyroglobulin >10ng/ml and negative I-131 whole body scan.

Also in Section 50-36, for: Soft Tissue Sarcoma, and for: Dementia and Neurogenerative Diseases, Medicare maintains its national noncoverage determinations for all uses of FDG-PET.

This revision to the Coverage Issues Manual is a national coverage determination (NCD). NCDs are binding on all Medicare carriers, intermediaries, peer review organizations, health maintenance organizations, competitive medical plans, and health prepayment plans. Under 42 CFR 422.256(b), an NCD that expands coverage is also binding on a Medicare+Choice Organization. In addition, an administrative law judge may not review an NCD. (See §1869(f)(1)(A)(i) of the Social Security Act.)

[EM 2003-0590; EM 2003-0594/CR 2687; EM 2003-0591/AB-03-092]
(04-0215)

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Processing Claims for Out of State Independent Clinical Diagnosis Laboratories

I. General Information

A. Background:

Medicare recognizes that a clinical diagnostic laboratory may refer a specimen to another clinical diagnostic laboratory for testing. Generally, Medicare requires that the entity that furnishes the service, in this case the clinical diagnostic laboratory that performs the test, bill for the service. However, § 1833(h)(5)(A)(ii) of the Social Security Act permits, under certain conditions, a clinical diagnostic laboratory to bill for a clinical diagnostic laboratory fee schedule service that was performed by another clinical diagnostic laboratory. This Transmittal updates the claims processing rules for processing claims submitted by independent clinical diagnostic laboratories when the claim is for a service referred by one laboratory to another.

Medicare uses certain terms of art in the context of laboratory-to-laboratory referrals. Medicare defines a referred clinical diagnostic laboratory service/test as a service performed by one laboratory at the request of another laboratory. “Referring laboratory” is defined as the laboratory that refers a specimen to another laboratory for testing. “Reference laboratory” is defined as the laboratory that receives a specimen from another laboratory and that performs one or more tests on such specimen.

Medicare’s payment policy for laboratory services is, generally, based on fee schedules and each carrier jurisdiction has its own fee schedule. Many carriers have been unable to process a claim for a referred clinical diagnostic laboratory test when the test was performed in another jurisdiction because they did not possess the fee schedule of that other jurisdiction. Moreover, carriers have not been required to adjudicate a claim for a referred service furnished in another jurisdiction unless it happened to have available the clinical laboratory fee schedule for such jurisdiction. Thus, some carriers pay for referred services performed outside of their jurisdiction and some do not.

Some referring laboratories electing to bill for a referred service performed in another jurisdiction have been unable to have the claim processed by the carrier in which they are enrolled. These laboratories have attempted to overcome the difficulty by enrolling as a reference laboratory with the carrier having jurisdiction where the test was performed. Some carriers have permitted such enrollments and issued a Provider Identification Number (PIN) for the reference laboratory as a “reference-use-only” PIN. However, not every carrier has been willing to issue “reference-use-only” PINs.

These instructions resolve these issues by requiring that: 1) an independent clinical laboratory may bill only the carrier in which it is enrolled by reason of having a physical presence; 2) an independent clinical laboratory may not enroll with a carrier as a “reference-use-only” laboratory; 3) every carrier must adjudicate a claim for a referred service, regardless of where the service was performed, if the claim is submitted by a laboratory located in its jurisdiction; 4) every carrier must pay for a referred service on the basis of the fee schedule in effect in the jurisdiction where the test was performed; 5) every carrier must cancel all existing “reference-use-only” enrollments and “reference-use-only” PINs and refrain from making any further “reference-use-only” enrollments; 6) the referring laboratory must identify a referred service as such on the claim and identify reference laboratory performing such test; and 7) both the referring laboratory and the reference laboratory must be enrolled in Medicare.

B. Policy:

Although Medicare payment may generally be made to an independent clinical laboratory only for those tests that it performs, payment may also be made to a laboratory for a test that are on the clinical laboratory fee schedule that it has referred to another laboratory, provided the referring laboratory meets one of the following three conditions:

The Medicare allowed amount for a referred test is based on the fee schedule in effect where the test was performed. For services that are carrier priced, the reimbursement amount will be based upon the price developed by the carrier processing the claim.
The billing laboratory, whether it is the referring laboratory or the reference laboratory, must submit its claim to the carrier in which it is enrolled by reason of having a physical presence.

When the billing laboratory is the referring laboratory it must:

Paper Claim Submission

Provider Information

Suppliers that submit claims in the paper format (CMS-1500 claim form) may not combine services that they performed themselves and any that they referred to another laboratory on the same CMS-1500 claim form. If a billing laboratory performs some testing and refers the remaining tests to another (referral) laboratory to perform, the laboratory must split the claim and submit two separate claims. If services are referred to more than one laboratory, a separate claim must be submitted for each laboratory that services were referred to. Referral laboratory claims submitted to carriers are permitted only for independent clinical laboratories, specialty code 69. The performing laboratory’s name and address must be reported in item 32 on the CMS-1500 form to show where the service (test) was actually performed.

CLIA Number

A paper claim for laboratory testing requires the presence of the CLIA number performing the testing in item 23 on the CMS-1500 billing form. A claim for laboratory testing must be submitted as follows:

Electronic Claim Submission

American National Standards Institute (ANSI) X12N 837 (HIPAA version) format electronic claims:

CLIA number:

An ANSI claim for laboratory testing will require the presence of the performing (and billing) laboratory’s CLIA number; if tests are referred to another laboratory, the CLIA number of the laboratory where the testing is rendered must also be on the claim. An ANSI electronic claim for laboratory testing must be submitted using the following format:

Reference Laboratory’s Address

An electronic claim for laboratory testing requires the presence of the performing and billing laboratory’s, name and address. The performing laboratory for a service with a line item CPT 90 modifier requires provider information for the X12N 837 in Loop 2420C.

National Standard Format (NSF) Electronic Claims:

CLIA number:

An NSF claim for laboratory testing will require the presence of the performing (and billing) laboratory’s CLIA number: if tests are referred to another laboratory, the CLIA number of the laboratory where the testing is rendered must be on the claim. An NSF electronic claim for laboratory testing must be submitted using the following format:

The electronic claim will not be split; CLIA numbers from both the billing and reference laboratories must be submitted on one claim. The presence of the ‘90’ modifier at the line item identifies the referral tests The CLIA number reported on line items with modifier 90 will be the CLIA number of the performing clinical diagnostic laboratory. Referral laboratory claims are only permitted for independently billing clinical laboratories, specialty code 69.

The CLIA number shall be reported in: FA0 – 34.0

Reference Laboratory’s Address

An NSF electronic claim for laboratory testing requires the presence of the performing and billing laboratory’s, name and address. The performing laboratory for a service with a line item CPT ‘90’ modifier requires provider information to be submitted in the following NSF record and fields:

FB0 – 27.0 Name
FB0 – 28.0 Address 1
FB0 – 29.0 Address 2
FB0 – 30.0 City
FB0 – 12.0 State
FB0 – 31 Zip

[EM 2003-0983/CR 2193]
(04-0259)

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Purchased Diagnostic Services by an Independent Laboratory

Currently claims for purchased diagnostic services are adjudicated based on a policy established in the paper based Medicare Carriers Manual (MCM).  The former paper based MCM §15048 states that "If a physician or laboratory bills for a laboratory test performed by an outside supplier, the fee schedule amount for the purchased service equals the lower of the billing physician's/laboratory's fee schedule or the price paid for the service."  This means we paid the lower of the fee schedule or the purchase price or the submitted charge of the purchased technical component for both physician and Independent Laboratory claims.  The physician/supplier had to identify the supplier providing the technical component. 

The carrier shared systems are currently programmed to enforce this policy as stated in the old manuals.  The updated Internet Only Manual has changed this policy to state that the payment rule applies only to physicians.

A professional component (PC) service is not relevant for this policy and business rule.  The purchase price of the PC portion is not and should not be a part of the adjudicative process. 

Publication 100-04  Chapter 1 §30.2.9; Payment to Physician for Purchased Diagnostic Tests - Claims Submitted to Carriers, states "A physician or a medical group may submit the claim and (if assignment is accepted) receive the Part B payment, for the technical component of diagnostic tests which the physician or group purchases from an independent physician, medical group, or other supplier.  (This claim and payment procedure does not extend to clinical diagnostic laboratory tests.)  The purchasing physician or group may be the same physician or group as ordered the tests or may be a different physician or group.  An example of the latter situation is when the attending physician orders radiology tests from a radiologist and the radiologist purchases the tests from an imaging center.  The purchasing physician or group may not markup the charge for a test from the purchase price and must accept the lowest of the fee schedule amount if the supplier had billed directly; the physician's actual charge; or the supplier's net charge to the purchasing physician or group, as full payment for the test even if assignment is not accepted."

A new policy is being added to Publication 100-04 Chapter 16 §40.2 that clarifies that when an independent laboratory bills for a laboratory test performed by an outside supplier, the payment amount for the purchased service is based on the lower of the submitted charge or the fee on the Medicare Physician Fee Schedule (MPFS)."  The independent laboratory must perform at least one of the services billed.  If the service being billed is the professional component of a test, the independent laboratory must meet the rules of Publication 100-04  Chapter 1 §30.2.6.

Purchased diagnostic tests are paid using the MPFS, thus, the jurisdiction rules for the MPFS apply.

[EM 2003-0964/CR 2919]
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Railroad Medicare Carrier – New Enrollment Process Effective November 3, 2003

Beginning November 3, 2003, physicians and suppliers requiring Railroad Medicare Carrier (RMC) enrollment will no longer be required to submit an RMC application for enrollment or changes of information. All enrollment information will be captured through the Medicare Part B enrollment process. Physicians and suppliers will still be required to submit claims to the RMC. However, they must ensure that prior to submitting claims, the provider/supplier information is the same as that used to submit claims to the Medicare Carrier.

New providers/suppliers should obtain a Medicare Part B Provider Identification Number (PIN). New RMC providers/suppliers will be issued an RMC PIN once their claim has been submitted. Established and new Railroad Medicare providers/suppliers should use their RMC provider/supplier PIN when submitting claims for RMC beneficiaries.

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Claims for Ventricular Assist Devices for Beneficiaries in a Medicare+Choice Plan – Billing Instructions

I. General Information

A. Background: This Change Request (CR) provides billing instructions for claims for ventricular assist devices (VADs) for beneficiaries in a Medicare+Choice (M+C) Plan.

The Centers for Medicare & Medicaid Services (CMS) has recently expanded coverage for ventricular assist devices (VADs) (see National Coverage Determination (NCD) Manual Section 20.9). Until Medicare capitation rates to M+C organizations are adjusted to account for this expanded VADs coverage, Medicare will pay providers on a fee-for-service basis for VADs that fall under the new indication for destination therapy (see NCD manual section 20.9).

B. Policy: The fee-for-service claims processing system automatically excludes claims for services provided for risk M+C beneficiaries except in certain circumstances for which editing has been created (e.g. NETT claims, clinical trials claims).

This CR instructs physicians/practitioners to use the modifier KZ (new coverage not implemented by managed care) and hospitals to use condition code 78 (new coverage not implemented by HMO) when billing for services for VADs for beneficiaries in an M+C plan when conditions fall under the new indications for destination therapy, which are effective October 1, 2003.

Until the new capitation rates to M+C organizations are in effect to include the cost of this expanded coverage, payment for VADs furnished to beneficiaries enrolled in risk M+C plans will be determined according to the applicable fee-for-service rules, except that beneficiaries are not responsible for the Part A and Part B deductibles (i.e., assume the Part A or Part B deductible has been met). M+C enrollees are liable for the coinsurance amounts applicable to services paid under Medicare fee-for service rules.

NOTE: Claims for M+C organizations’ beneficiaries with existing covered indications (see NCD manual section 20.9) should NOT be billed with the condition code or modifier since the existing covered indications are currently included in the M+C plan’s capitated rates.

[EM 2003-0939/CR 2958]
(04-0201)

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Ventricular Assist Devices (VADs) for Destination Therapy

This provider education article discusses the expansion in Medicare coverage for VADs for destination therapy for certain services performed on and after October 1, 2003. The article also discusses VAD claims processing and provides VAD information resources.

Background

For services performed on and after October 1, 2003, coverage has been expanded for VADs when used as destination therapy under the following conditions:

NOTE:  All other indications for the use of VADs remain the same.

VAD Claims Processing Information

Services Provided to Medicare+Choice (M+C) Patients

Services Provided to Fee-for-Service Patients

VAD Information Resources

http://www.cms.hhs.gov/manuals/cmsindex.asp

Pub. 100-03 - Medicare National Coverage Determination Manual, Section 20.9
[EM 2003-1010/CR 2985]
(04-0254)

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Provider Enrollment Cares About You!

We care about you, the Provider Community. Therefore Provider Enrollment’s top priority is to process all enrollment applications in a timely manner. To accomplish this priority the enrollment applications you send us must be completed correctly.

Our goal is to process any Form CMS-855R, request for change and reactivation that is not with an initial enrollment within 45 calendar days of receipt or sooner 90 percent of the time; process 99 percent of these type of applications within 60 days of receipt; process 90 percent of any Form CMS-855B, CMS-855I and CMS-855I with an 855R within 60 calendar days of receipt or sooner and to process 99 percent of these type of applications within 120 calendar days of receipt.

The following list includes some of the most commonly found errors on the CMS-855I Application for Health Care Practitioners. Please take a moment to review these common errors.

Here are some additional tips to remember:

If you have any questions concerning the enrollment application(s), please contact CIGNA Government Services’s Provider Enrollment department at 866.520.4007.

(04-0311)

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Clinical Diagnostic Laboratory

The annual update to the local clinical laboratory fees for 2004 is 2.6 percent.

The Part B deductible and coinsurance do not apply for services paid under the clinical laboratory fee schedule. The three month grace period for deleted codes begins January 1, 2004.

Pricing Information

The 2004 laboratory fee schedule includes separately payable fees for certain specimen collection methods (codes G0001, P9612, and P9615). The fees have been established in accordance with §1833(h)(4)(B) of the Act.

Instructions on separately payable fees for traveling to perform a specimen collection for either a nursing home or homebound patient were issued in June 1999. There are two codes: P9603 for a per mileage trip basis or code P9604 for a flat rate trip basis where the average round trip is generally less than 20 miles (or an average of 10 miles per leg of the trip). To bill either code requires documentation of the number of specimens performed per trip (for both Medicare and non-Medicare patients) to compute the Medicare prorated fee. Code P9604 requires the laboratory to determine the appropriateness of billing on an average round trip basis for all trips during a one-year time period. Thus, payment for travel under code P9604 is made to reasonably pay on average for a varying range of trip miles so that the laboratory should not also require payment with another basis (e.g., code P9603). The payment for codes P9603 and P9604 reflects personnel and transportation costs. For dates of service January 1, 2004, through December 31, 2004, the personnel payment is $.46 per mile. For dates of service January 1, 2004, through December 31, 2004, the standard mileage rate for transportation costs is $0.375. The 2004 payment for code P9603 is $.835 and for code P9604 is $8.35. The standard mileage rate can also be found at the Web site www.irs.gov.

The 2004 laboratory fee schedule also includes codes that have a ‘QW’ modifier to both identify codes and determine payment for tests performed by a laboratory registered with only a certificate of waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

National Minimum Payment Amounts

For a cervical or vaginal smear test (pap smear), §1833(h)(7) of the Act requires payment to be the lesser of the local fee or the NLA, but not less than a national minimum payment amount. Also, payment may not exceed the actual charge. The 2004 national minimum payment amount is $15.14 ($14.76 plus 2.6 percent update for 2004). The affected codes for the national minimum payment amount are 88142, 88143, 88147, 88148, 88150, 88152, 88153, 88154, 88164, 88165, 88166, 88167, 88174, 88175, G0123, G0143, G0144, G0145, G0147, G0148, and P3000.

Laboratory Costs Subject to Reasonable Charge Payment in 2004

For outpatients, the following codes are paid under a reasonable charge basis. In accordance with §42 CFR 405.502 - 405.508, the reasonable charge may not exceed the lowest of the actual charge or the customary or prevailing charge for the previous 12-month period ending June 30, updated by the inflation-indexed update. The inflation-indexed update is calculated using the change in the applicable Consumer Price Index for the 12-month period ending June 30 of each year as prescribed by §1842(b)(3) of the Act and §42 CFR 405.509(b)(1). The inflation-indexed update for year 2004 is 2.1 percent.

When these services are performed for independent dialysis facility patients, Medicare Claims Processing Manual, Pub. 100-04, chapter 8, §60.3 instructs the reasonable charge basis applies. However, when these services are performed for hospital based renal dialysis facility patients, payment is made on a reasonable cost basis.

Also, when these services are performed for hospital outpatients, payment is made under the hospital outpatient prospective payment system (OPPS).

Blood Products

P9010 P9011 P9012 P9016 P9017 P9019 P9020 P9021 P9022 P9023 P9031 P9032 P9033 P9034 P9035 P9036 P9037 P9038 P9039 P9040 P9044 P9050 P9051 P9052 P9053 P9054 P9055 P9056 P9057 P9058 P9059

Transfusion Medicine

86850 86860 86870 86880 86885 86886 86890 86891 86900 86901 86903 86904 86905 86906 86920 86921 86922 86927 86930 86931 86932 86945 86950 86965 86970 86971 86972 86975 86976 86977 86978 86985 G0267

Reproductive Medicine Procedures

89250 89251 89253 89254 89255 89257 89258 89259 89260 89261 89264 89268 89272 89280 89281 89290 89291 89335 89342 89343 89344 89346 89352 89353 89354 89356

Please refer to the state-specific insert for the 2004 Clinical Lab Fee Schedule.

[EM 2003-1003/CR 2959]
(04-0308)

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Electronic Funds Transfer (EFT)

New Authorization Agreement for Electronic Funds Transfer Application

The Authorization Agreement For Electronic Funds Transfer (Form CMS-588 [09/03]) application has been revised to include privacy act information. This will help ensure that the information provided to us will be used to authorize electronic funds transfers from our bank to yours.

When the completed EFT Authorization form is submitted to CIGNA Government Services, electronic payments will begin within 10-15 business days assuming all information is accurate and complete.

Enroll in the EFT program by using the new form available at www.cignamedicare.com/eft and on the CMS Web site at www.cms.hhs.gov/forms/cms588.pdf. The older forms will no be longer be accepted after January 1, 2004.

Stop waiting for your check to arrive in the mail - CIGNA Government Services can deposit your claims’ payment for you!

(04-0314)

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Pneumococcal, Hepatitis B, and Influenza Virus Vaccines – Medicare Coverage

Coverage of the pneumococcal vaccine (PPV), hepatitis B vaccine, and influenza virus vaccine and their administration is available only under Medicare Part B, regardless of the setting in which they are furnished, even when provided to an inpatient during a hospital stay covered under Part A. Payment is 100 percent of the Medicare allowed amount for PPV and influenza virus vaccine. Part B deductible and coinsurance do not apply for PPV and influenza virus vaccine. Part B deductible and 20 percent coinsurance do apply for hepatitis B vaccine.

State laws governing who may administer PPV and influenza virus vaccinations and how the vaccines may be transported vary widely. Physicians and suppliers should become familiar with state regulations for all vaccines in the areas where they will be immunizing.

Pneumococcal Pneumonia Vaccinations

The Medicare Part B program covers pneumococcal pneumonia vaccine and its administration when furnished in compliance with any applicable State law by any provider of services or any entity or individual with a supplier number. This includes revaccination of patients at highest risk of pneumococcal infection. Typically, these vaccines are administered once in a lifetime except for persons at highest risk. Effective July 1, 2000, Medicare does not require for coverage purposes that the vaccine must be ordered by a doctor of medicine or osteopathy. Therefore, the beneficiary may receive the vaccine upon request without a physician’s order and without physician supervision.

An initial vaccine may be administered only to persons at high risk (see below) of pneumococcal disease. Revaccination may be administered only to persons at highest risk of serious pneumococcal infection and those likely to have a rapid decline in pneumococcal antibody levels, provided that at least five years have passed since receipt of a previous dose of pneumococcal vaccine.

Persons at high risk for whom an initial vaccine may be administered include all people age 65 and older; immunocompetent adults who are at increased risk of pneumococcal disease or its complications because of chronic illness (e.g., cardiovascular disease, pulmonary disease, diabetes mellitus, alcoholism, cirrhosis, or cerebrospinal fluid leaks); and individuals with compromised immune systems (e.g., splenic dysfunction or anatomic asplenia, Hodgkin’s disease, lymphoma, multiple myeloma, chronic renal failure, HIV infection, nephrotic syndrome, sickle cell disease, or organ transplantation).

Persons at highest risk and those most likely to have rapid declines in antibody levels are those for whom revaccination may be appropriate. This group includes persons with functional or anatomic asplenia (e.g., sickle cell disease, splenectomy), HIV infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, or other conditions associated with immunosuppression such as organ or bone marrow transplantation, and those receiving immunosuppressive chemotherapy. Routine revaccination of people age 65 or older who are not at highest risk is not appropriate.

Those administering the vaccine should not require the patient to present an immunization record prior to administering the pneumococcal vaccine, nor should they feel compelled to review the patient’s complete medical record if it is not available. Instead, provided that the patient is competent, it is acceptable for them to rely on the patient’s verbal history to determine prior vaccination status. If the patient is uncertain about their vaccination history in the past five years, the vaccine should be given. However, if the patient is certain he/she was vaccinated in the last five years, the vaccine should not be given. If the patient is certain that the vaccine was given and that more than five years have passed since receipt of the previous dose, revaccination is not appropriate unless the patient is at highest risk.

Hepatitis B Vaccine. Coverage under Part B extends to hepatitis B vaccine and its administration, furnished to a Medicare beneficiary who is at high or intermediate risk of contracting hepatitis B. High-risk groups currently identified include (see exception below):

Intermediate risk groups currently identified include:

EXCEPTION: Persons in the above-listed groups would not be considered at high or intermediate risk of contracting hepatitis B, however, if there is laboratory evidence positive for antibodies to hepatitis B. (ESRD patients are routinely tested for hepatitis B antibodies as part of their continuing monitoring and therapy.)

For Medicare program purposes, the vaccine may be administered upon the order of a doctor of medicine or osteopathy by home health agencies, skilled nursing facilities, ESRD facilities, hospital outpatient departments, persons recognized under the incident to physicians’ services provision of law, and doctors of medicine and osteopathy.

Influenza Virus Vaccine. Medicare Part B covers influenza virus vaccine and its administration when furnished in compliance with any applicable State law by any provider of services or any entity or individual with a supplier number. Typically, these vaccines are administered once a year in the fall or winter. Medicare does not require for coverage purposes that the vaccine must be ordered by a doctor of medicine or osteopathy. Therefore, the beneficiary may receive the vaccine upon request without a physician’s order and without physician supervision.

Billing for Pneumococcal, Hepatitis B, and Influenza Virus Vaccines

Billing for Additional Services. When a provider administers PPV, influenza virus, or hepatitis B vaccines without providing any other additional services during the visit, the provider may only bill for the vaccine and its administration. These services are always separately payable, whether or not other services are also provided during the same encounter. The provider may bill for additional reasonable and necessary services in addition to the administration of PPV, influenza virus, and or hepatitis B vaccines.

Nonparticipating Physicians and Suppliers. Effective for claims with dates of service on or after February 1, 2001, §114 of the Benefits Improvement and Protection Act of 2000 mandated that all drugs and biologicals be paid based on mandatory assignment. Therefore, all providers must accept assignment for the vaccines even if the provider normally does not accept assignment. Nonparticipating physicians and suppliers (including local health facilities) that usually do not accept assignment may not collect payment from the beneficiary for the vaccine. They must file an assigned claim for the vaccine.

Assignment for the administration is not mandatory (but is applicable should the provider be enrolled as a provider type “Mass Immunizer,” submits roster bills, or participates in the centralized billing program). If nonparticipating physicians and suppliers (including local health facilities) wanted, they could collect payment from the beneficiary for the administration cost (but must submit an unassigned claim on the beneficiary’s behalf). Most providers prefer to file one assigned claim for both the vaccine and the administration. Entities, such as local health facilities, that have never submitted Medicare claims must obtain a provider identification number for Part B billing purposes.

CPT Codes

90657 Influenza virus vaccine, split virus, 6-35 months dosage, for intramuscular orjet injection use
90658 Influenza virus vaccine, split virus, 3 years and above dosage, forintramuscular or jet injection use
90659 Influenza virus vaccine, whole virus, for intramuscular or jet injection use
90723 Diphtheria, tetanus toxoids, and Acellular pertussis vaccine, Hepatitis B and Poliovirus vaccine, inactivated (DTAP-HEPB-IPV), for intramuscular use
90732 Pneumococcal polysaccharide vaccine, 23-valent, adult or immunosuppressedpatient dosage, for subcutaneous or intramuscular use
90740 Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (3 dose schedule), for intramuscular use
90743 Hepatitis B vaccine, adolescent (2 dose schedule), for intramuscular use
90744 Hepatitis B vaccine, pediatric or pediatric/adolescent dosage (3 dose schedule), for intramuscular use
90746 Hepatitis B vaccine, adult dosage, for intramuscular use
90747 Hepatitis B vaccine, dialysis or immunosuppressed patient dosage (4 dose schedule), for intramuscular use
90748 Hepatitis B and Hemophilus influenza B vaccine (HepB-Hib), for intramuscular use

These codes are for the vaccines only and do not include their administration. The following HCPCS “G” codes are used to bill for administration of vaccines:

G0009 Administration of pneumococcal vaccine
G0008 Administration of influenza virus vaccine
G0010 Administration of hepatitis B vaccine

Billing Requirements. Physicians and suppliers submit claims electronically or on Form CMS-1500. The Unique Physician Identification Number (UPIN) must be entered in Item 17A of Form CMS-1500 or its electronic equivalent field for hepatitis B vaccines. No UPIN is required for influenza virus and PPV vaccine claims since Medicare does not require that the influenza and pneumococcal vaccine be administered under a physician’s order or supervision.

Diagnosis Codes. The following diagnosis codes for PPV and influenza virus and hepatitis B vaccines and their administration should appear in Item 21 of Form CMS-1500 or its equivalent electronic field:

V03.82 PPV
V04.81 Influenza virus vaccine