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November 6, 2007 Part B Medicare Bulletin

Posted November 6, 2007

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2008 Annual Update for the Health Professional Shortage Area (HPSA) Bonus Payment

News Flash – The Centers for Medicare & Medicaid Services (CMS) is pleased to announce that reporting for the 2007 PQRI on claims for dates of service as of July 1, 2007, has begun. Eligible professionals can now start participating in the PQRI by simply reporting the appropriate quality measure data on claims submitted to their Medicare claims processing contractor. Remember, all your informational needs can be met by visiting the PQRI Web site at http://www.cms.hhs.gov/PQRI. Here you will find educational resources, including the PQRI Tool Kit, and links to our most Frequently Asked Questions (FAQs).

Provider Types Affected
Physicians and providers submitting claims to Medicare Administrative Contractors (A/B MACs), carriers, and fiscal intermediaries (FIs) for services provided in HPSAs.

Impact on Providers
This article is based on Change Request (CR) 5698, which alerts affected physicians, carriers, A/B MACs and FIs that the new HPSA bonus payment information for 2008 will be available soon. This article is informational only for physicians that the 2008 automated bonus payments applies to claims with dates of service on or after January 1, 2008 through December 31, 2008.

Background
The Medicare Prescription Drug Improvement and Modernization Act of 2003 (Section 413(b)) mandated an annual update to the automated HPSA bonus payment files, and the Centers for Medicare & Medicaid Services (CMS) creates these new automated HPSA bonus payment files annually. The 2008 HPSA bonus payment file will be used for the automated bonus payment for claims with dates of service on or after January 1, 2008, through December 31, 2008. Physicians and providers should review the CMS Web site to determine whether a HPSA bonus will automatically be paid for services provided in their ZIP code area or whether a modifier must be submitted.

In addition, physicians will find annual HPSA bonus payment files, as they become available, and other important HPSA information at http://www.cms.hhs.gov/hpsapsaphysicianbonuses/ on the CMS Web site.

Additional Information
The official instruction (CR5698) issued to your Medicare A/B MAC, carrier, or FI is available at
http://www.cms.hhs.gov/Transmittals/downloads/R1320CP.pdf on the CMS Web site.

For the CMS information about HPSA/PSA (Physician Bonuses), you may visit: http://www.cms.hhs.gov/HPSAPSAPhysicianBonuses/ on the CMS Web site.

If you have questions, please contact your Medicare A/B MAC, carrier, or FI at their toll-free number which may be found at: http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

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4th Quarter Update Part B Not Otherwise Classified Drug Fee Schedule 2007 Payment Allowance Limits for Medicare Part B Not Otherwise Classified (NOC) Drugs

4th Quarter Update Part B Not Otherwise Classified Drug Fee Schedule 2007 Payment Allowance Limits for Medicare Part B Not Otherwise Classified (NOC) Drugs

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Alert Regarding the Transition of the Medigap Claim-Based Crossover Process

The Centers for Medicare & Medicaid Services (CMS) has made a decision to delay the use of the new Coordination of Benefits Agreement (COBA) Medigap claim-based identifiers on incoming Part B claims or claims for durable medical equipment, prosthetics, orthotics, and medical supplies (DMEPOS) until October 1, 2007. This represents a change from previous CMS direction issued in accordance with Transmittal 283, Change Request (CR) 5662, and the accompanying MLN Matters Article.

Because of the CMS delay, physicians and other suppliers shall inform their billing vendors not to include any newly assigned 5-byte COBA Medigap claim-based identifiers, as referenced at
http://www.cms.hhs.gov/COBAgreement/Downloads/Medigap%20Claim-based%20COBA%20IDs%20for%20Billing%20Purpose.pdf, on incoming Medicare claims before October 1, 2007. If participating providers or suppliers include the newly assigned COBA Medigap claim-based ID on incoming claims before October 1, 2007, Medicare will not cross the claims over to the Medigap insurer.

Providers that use PC-Ace or other free billing Medicare software need to ensure this product is updated to reflect the newly assigned 5-byte COBA Medigap claim-based IDs but must ensure that the new identifiers will not be applied on incoming Medicare claims before October 1, 2007.

Effective with October 1, 2007, and as specified in Transmittal 283, CR 5662, physicians and other suppliers that bill using paper forms, i.e., those granted an exception for billing electronically under the Administrative Simplification Compliance Act (ASCA), shall include the newly assigned 5-byte identifier (number will fall in the range 55000 through 59999) within item 9-D of incoming paper CMS-1500 claim forms. These providers should complete items 9A through 9D, in accordance with previous procedures, to ensure they will successfully trigger a Medigap claim-based crossover. Providers that are required to bill Medicare electronically using the Health Insurance Portability and Accountability Act (HIPAA) American National Standards Institute (ANSI) X12-N 837 professional claim shall include the newly assigned 5-byte only COBA Medigap claim-based ID (range=55000 to 59999) in field NM109 of the NM1 segment within the 2330B loop. Retail pharmacies that bill National Council for Prescription Drug Programs (NCPDP) batch claims to Medicare shall include the newly assigned Medigap identifier within field 301-C1 of the T04 segment of their incoming NCPDP claims.

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Anesthesia Services Furnished by the Same Physician Providing the Medical and Surgical Service

Note: This article was revised on August 28, 2007, to reflect changes made to CR5618 on August 27, 2007. CR5618 was modified to include the correct Medicare Summary Notice message number for notifying beneficiaries when they are not liable for payment. The CR transmittal number, release date, and the Web address for accessing CR5618 were also changed. All other information remains the same.

National Provider Identifier (NPI) News – During this testing and implementation phase for the NPI, providers should pay close attention to information from health plans and clearinghouses to understand how claims are being processed and what providers should be doing to assure no disruption in payment. Providers should also ensure that the information they are submitting on a claim is what is being transmitted to each health plan by the billing vendors or clearinghouses who may be submitting the claims on their behalf. Additional information can be found at http://www.cms.hhs.gov/NationalProvIdentStand/ on the CMS Web site.

Provider Types Affected
Physicians and other practitioners who bill Medicare carriers and/or Medicare Administrative Contractors (A/B MACs) for anesthesia services provided in conjunction with the performance of medical/surgical services.

Provider Action Needed

STOP – Impact to You
Physicians who both perform, and provide moderate sedation for, medical/surgical services will be paid for the conscious sedation consistent with CPT guidelines. However, physicians who perform, and provide local or minimal sedation for, these procedures will not be paid separately for the sedation services.

CAUTION – What You Need to Know
The Medicare Claims Processing Manual (Publication 100-04) Chapter 12 (Physicians/Nonphysician Practitioners) Section 50A (General Payment) is being revised to be consistent with the pricing of the conscious sedation codes under the Medicare physician fee schedule payment system and CPT coding guidelines. In addition, a new section, 50L, explains the payment policy when the same physician performs both the medical/surgical service and the conscious sedation service, is added. Finally, Exhibit 1, that listed the base units by anesthesia code is deleted, because it is out of date and the material is communicated to carriers and Medicare Administrative Contractors (known as A/B MACs) annually via the HCPCS tape.

GO – What You Need to Do
Make sure that your billing staffs are aware of these new payment policies that address the same physician performing both the medical/surgical service and the conscious sedation service.

Background
The continuum of complexity in anesthesia services (from least intense to most intense) ranges from 1) local or topical anesthesia, 2) moderate (conscious) sedation, 3) regional anesthesia, to 4) general anesthesia. Moderate sedation is a drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. It does not include minimal sedation, deep sedation or monitored anesthesia care.

CR 5618, from which this article is taken announces the revision of the anesthesia policy in the Medicare Claims Processing Manual, Chapter 12 (Physicians/Nonphysician Practitioners), Section 50A (General Payment), to be consistent with the pricing of conscious sedation codes under the Medicare physician fee schedule and CPT coding guidelines. It further announces:

  1. The addition of a new Section (50L), that explains the payment policy if the same physician performs the medical/surgical service and the conscious sedation service; and
  2. The deletion of Exhibit 1, that lists the base units by anesthesia code because it is out of date and the material is communicated to the carriers annually via the HCPCS tape.

Currently, section 50A instructs carriers and MACs not to allow separate payment for the anesthesia service performed by the same physician who furnishes the medical or surgical services (for example, there is no separate payment allowed for a surgeon’s performance of a local or surgical anesthesia if the surgeon also performs the surgical procedure; or a psychiatrist’s performance of the anesthesia service associated with the electroconvulsive therapy if the psychiatrist performs the electroconvulsive therapy).

The revised policy is: If the physician performing the procedure also provides moderate sedation for the procedure, then payment may be made for conscious sedation consistent with CPT guidelines; however, if the physician performing the procedure provides local or minimal sedation for the procedure, then no separate payment is made for the local or minimal sedation service.

Carriers and A/B MACS will not allow payment for codes 99148-99150 if any of these codes are performed on the same day with a medical/surgical service listed in Appendix G of CPT and the service is provided in a non-facility setting. A facility is defined in Chapter 23 Addendum of the Medicare Claims Processing Manual as one with a place of service code of 21, 22, 23, 24, 26, 31, 34, 41, 42, 51, 52, 53, 56, or 61.

Prior to 2006, Medicare did not recognize separate payment if the same physician both performed the medical or surgical procedure and provided the anesthesia needed for the procedure. The final physician fee schedule published in the Federal Register on November 21, 2005, included newly created codes (99143 to 99150) for moderate (conscious) sedation, which the CPT added in 2006.

Note: These codes have been assigned a status indicator of “C” under the Medicare physician fee schedule designating that these services are carrier priced. CMS has not established relative value units for these services.

Three of these codes (99143, 99144, and 99145) describe the scenario in which the same physician performing the diagnostic or therapeutic procedure provides the moderate sedation, and an independent trained observer’s presence is required to assist in the monitoring of the patient’s level of consciousness and physiological status. The other three codes (99148, 99149, and 99150) describe the scenario in which the moderate sedation is provided by a physician other than the one performing the diagnostic or therapeutic procedure.

CR 5618 presents some specific points that you should be aware of:

Additional Information
You can find the official instruction, CR 5618, issued to your carrier or A/B MAC by visiting http://www.cms.hhs.gov/Transmittals/downloads/R1324CP.pdf on the CMS Web site. You will find updated Medicare Claims Processing Manual (100-04), Chapter 12 (Physicians/Non-physician Practitioners) as an attachment to that CR.

If you have any questions, please contact your carrier or A/B MAC at their toll-free number, which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip.

 

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Billing 99211 for Anticoagulation Management

CPT code 99211 is the lowest level evaluation and management (E/M) service and does not require a physician face-to-face encounter with the patient. However, it does require direct physician supervision (i.e. the supervising physician must be present in the office when the service is rendered) of the ancillary staff who are conducting the face-to-face encounter. Services billed to Medicare under CPT code 99211 must be reasonable and necessary for the diagnosis and treatment of an illness or injury. This would include appropriately performed and documented anticoagulation management.

The following represents the guidelines that would be used in review of these charges as well as the errors that have previously been found on carrier or Comprehensive Error Rate Testing reviews.

99211 for Anticoagulation Management “Do’s”

99211 for Anticoagulation Management “Dont's”

Additionally (and not just limited to anticoagulation management), 99211 should not be used for:

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Clarification Concerning Provider Billing Procedures Related to the Transition of the Medigap Claim-Based Crossover Process to the Coordination of Benefits Contractor on October 1, 2007

News Flash - A new preventive services brochure entitled Adult Immunizations, ICN# 006435, is now available on the Centers for Medicare & Medicaid Services (CMS) Medicare Learning Network (MLN). This tri-fold brochure provides health care professionals with an overview of Medicare’s coverage of influenza, pneumococcal, and hepatitis B vaccines and their administration. The brochure is available at
http://www.cms.hhs.gov/MLNProducts/downloads/Adult_Immunization.pdf on the CMS Web site.

Provider Types Affected
Physicians and suppliers submitting claims to Part B Medicare contractors (including carriers, Medicare Administrative Contractors (A/B MACs), and durable medical equipment MACs (DME MACs).

Provider Action Needed
As instructed in MLN Matters article MM5601, all providers that bill their claims to Part B carriers, A/B MACs, or DMACs should, effective with October 1, 2007, begin to include a new Coordination of Benefits Agreement (COBA) Medigap 5-byte COBA ID (range 55000 to 59999) on incoming Medicare paper claims (CMS-1500), or incoming Health Insurance Portability and Accountability Act (HIPAA) 837 professional (version 4010A1), or National Council for Prescription Drug Programs (NCPDP) version 5.1 batch standard 1.1 claims to trigger crossovers to those Medigap insurers that are participating in the Centers for Medicare & Medicaid Services (CMS) new COBA Medigap claim-based process.

Providers should be including only the new 5-byte COBA Medigap claim-based ID on incoming Medicare claims effective October 1, 2007, for the purpose of triggering crossovers to those Medigap insurers that have been assigned a COBA Medigap claim-based ID that falls in the range of 55000 through 59999. The link to the Medigap Billing ID spreadsheet, which providers or their billing vendors should consult for this purpose, remains as http://www.cms.hhs.gov/COBAgreement/Downloads/Medigap%20Claim-based%20COBA%20IDs%20for%20Billing%20Purpose.pdf on the CMS Web site.

Though the number of entities that have requested COBA Medigap claim-based IDs is currently not very large, providers and their billing vendors should continue to consult this listing for purposes of noting changes. Please be assured the list is complete and accurate. Providers or their billing vendors should include only the Medigap COBA IDs on this list (range 55000 through 59999) on Medicare claims for purposes of triggering crossovers to Medigap insurers. Providers or their billing vendors should not include any of the eligibility file-based COBA IDs (ranges 00001-29999; 30000-54999; 60000-69999; 70000-79999; and 80000-89999) on inbound claims to Medicare.

Effective October 1, 2007, if a provider or its billing vendor files a Medicare claim with a COBA ID other than the COBA Medigap IDs on the above-referenced Medigap Billing ID list, Medicare will generate an MA-19 message on the provider’s 835 electronic remittance advice (ERA) or other remittance advice in use. This message indicates: “Information was not sent to the Medigap insurer due to incorrect/invalid information you submitted concerning that insurer. Please verify your information and submit your secondary claim directly to that insurer.”

As a reminder, all entities that participate in the COBA eligibility file-based crossover process or automatic complementary crossover process may be referenced at http://www.cms.hhs.gov/COBAgreement/Downloads/Contacts.pdf on the CMS Web site.

Providers should not contact those insurers or payers listed as participating in the automatic crossover process for purposes of determining whether CMS has assigned them a COBA Medigap claim-based ID. As aforementioned, providers or their billing vendors should also not utilize COBA ID information from this listing on their incoming Medicare claims for the purpose of triggering Medigap claim-based crossovers. IMPORTANT: Not every Medigap insurer is utilizing the automatic crossover process for the purpose of identifying all of its covered members or policyholders for crossover purposes and for receiving crossover claims for those Medicare beneficiaries. An example of this scenario is as follows: If the COBC was approached by a new Medigap insurer that specified that it needed to apply for a Medigap claim-based ID (range 55000 to 59999) for various segments of its covered membership, but will utilize the automatic complementary crossover process for the remainder of its Medigap membership, the COBC would, following execution of the COBA crossover agreement with the insurer, assign it two COBA IDs—one for automatic crossover (range 30000 to 54999 for automatic Medigap eligibility file-based crossover) and the other for Medigap claim-based crossover (55000 to 59999). Thus, this Medigap insurer would appear on both the listing of automatic crossover insurers as well as the Medigap Billing ID listing at the respective URL links on the COB Web site, referenced above.

Background
All supplemental insurers are required to sign a national COBA crossover agreement with CMS’ Coordination of Benefits Contractor (COBC) if they participate in CMS’ automatic complementary crossover (COBA eligibility file-based crossover) process or in the COBA Medigap claim-based crossover process. Providers should know that it is never their responsibility to request or obtain new Medigap 5-byte IDs for their patients’ Medigap insurers through the signing of a national COBA crossover agreement.

In MLN Matters article, MM5662, CMS informed its affected provider community that, during June through August 2007, its COBC would assign a new 5-byte COBA Medigap claim-based identifier (range=55000 to 59999) to a Medigap insurer after it has signed a national crossover agreement with the COBC. Despite repeated outreach communications to the health insurance industry, not all Medigap insurers have, as instructed, contacted the COBC to specify which approach, among three available options, they will exercise to ensure continued receipt of crossover claims on and after October 1, 2007.

The three (3) options available to each Medigap insurer for addressing its receipt of Medicare crossovers remain as follows:

To be clear, if a Medigap insurer is currently participating fully in the automatic (or COBA eligibility file-based) crossover process, it merely needs to inform the COBC of this decision. Upon doing so, that Medigap insurer will experience no disruption in its receipt of crossover claims. Based upon its most recent review of trending, CMS has noted that the vast majority of the larger, more commonly known Medigap insurers, which were already participating fully in the Medicare automatic crossover process, have informed CMS and the COBC that they plan to continue to participate fully in the automatic crossover process for purposes of fulfilling their mandatory Medigap crossover payment responsibilities on behalf of their Medigap policyholders. In other words, the majority of the larger, more commonly known Medigap insurers have exercised option #1, above.

Additional Information
You can find MLN Matters articles MM5061 and MM5662 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5601.pdf and http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5662.pdf on the CMS Web site.

If you have any questions, please contact your carrier, A/B MAC, or DME MAC at their toll-free number found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

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Discontinuance of the Unique Physician Identification Number (UPIN) Registry

Note: This article was revised on September 17, 2007, to reflect changes made to CR5584, which CMS re-issued on September 14, 2007. The article was revised to show that the UPIN Registry Web site and lookup functionality will be available through May 23, 2008. Information was added regarding the release of information, including NPIs, via the NPPES. The CR transmittal number, Web address for accessing CR5584, and the CR release date were also changed. All other information remains the same.

Physician Quality Reporting Initiative (PQRI) Measures and Specifications
The Centers for Medicare & Medicaid Services (CMS) is pleased to announce that the 2007 Physician Quality Reporting Initiative (PQRI) Quality Measures and Specifications are now available. To access both the measures and measure specifications documents, visit the PQRI Web page at http://www.cms.hhs.gov/PQRI on the CMS Web site. Once there, go to the Measures/Codes section of the page and scroll down to the Downloads section. Please note that many of the quality codes are new and will be rejected by Medicare claims processing systems prior to the July 1, 2007 HCPCS update.

Provider Types Affected
Physicians, providers, and suppliers submitting claims to Medicare contractors (carriers, Durable Medical Equipment Medicare Administrative Contractors (DME MACs), Fiscal Intermediaries (FIs), Part A/B Medicare Administrative Contractors (A/B MACs), and/or Regional Home Health Intermediaries (RHHIs)) for services provided to Medicare beneficiaries.

Provider Action Needed

STOP – Impact to You
This article is based on Change Request (CR) 5584 which announces that the Centers for Medicare & Medicaid Services (CMS) will discontinue assigning Unique Physician Identification Numbers (UPINs) on June 29, 2007.

CAUTION – What You Need to Know
The National Provider Identifier (NPI) is a requirement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and the NPI will replace the use of UPINs and other existing legacy identifiers. (However, CMS recently announced a contingency plan that allows for use of legacy numbers for some period of time beyond May 23, 2007. Under the Medicare FFS contingency plan, UPINs and surrogate UPINs may still be used to identify ordering and referring providers and suppliers until further notice.) Information on that contingency plan is at http://www.cms.hhs.gov/NationalProvIdentStand/downloads/NPI_Contingency.pdf on the CMS site.)

GO – What You Need to Do
If you do not have an NPI, you should obtain one as soon as possible. Applying for an NPI is fast, easy and free by going to the National Plan and Provider Enumeration System (NPPES) Web site at https://nppes.cms.hhs.gov/. See the Background and Additional Information Sections of this article for further details.

Background
The Centers for Medicare & Medicaid Services (CMS) was required by law to establish an identifier that could be used in Medicare claims to uniquely identify providers/suppliers who order services for Medicare patients or who refer Medicare patients to physicians and certain other suppliers. The UPIN was established to meet this requirement. CMS assigns UPINs to those physicians and eligible suppliers who are permitted by Medicare to order or refer in the Medicare program. Medicare claims for services that were ordered or for services that resulted from referrals must include UPINs to identify the providers/suppliers who ordered the services or made the referral.

On January 23, 2004, the Secretary of Health and Human Services published a Final Rule in which the Secretary adopted a standard unique health identifier to identify health care providers in transactions for which the Secretary has adopted standards (known as HIPAA standard transactions). This identifier is the National Provider Identifier (NPI). The NPI will replace all legacy provider identifiers that are used in HIPAA standard transactions, including the UPIN, to identify health care providers. All HIPAA covered entities (health plans, health care clearinghouses, and those health care providers who transmit any data electronically in connection with a HIPAA standard transaction) are required by that regulation to begin using NPIs in these transactions no later than May 23, 2007 (small health plans have until May 23, 2008). Medicare is also requiring the use of NPIs in paper claims no later than May 23, 2007, but see the note in the following box regarding the May 23, 2007 implementation by Medicare.

Important Note: Effective May 23, 2007, Medicare FFS is establishing a contingency plan for implementing the National Provider Identifier (NPI). In this plan, as soon as Medicare considers the number of claims submitted with an NPI for primary providers (Billing, pay-to and rendering providers) is sufficient, Medicare (after advance notification to providers) will begin rejecting claims without an NPI for primary providers, perhaps as early as July 1, 2007. For more information on this contingency plan, please visit the NPI dedicated Web site at http://www.cms.hhs.gov/NationalProvIdentStand/. This contingency plan does not affect CMS plans to discontinue assigning UPINs on June 29, 2007 or to disable the UPIN “look-up” functionality as of May 23, 2008.

The CMS discontinued assigning UPINs on June 29, 2007, but CMS will maintain its UPIN public “look-up” functionality and Registry Web site (http://www.upinregistry.com/) through May 23, 2008. In addition, CMS published the NPPES Data Dissemination Notice (CMS-6060-N) in the Federal Register on May 30, 2007. This Notice describes the policy by which information, to include NPIs, may be disseminated by CMS from the National Plan and Provider Enumeration System (NPPES).

Additional Information
For additional information regarding NPI requirements and use, please see MLN Matters articles, MM4023 (http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM4023.pdf) titled Requirements for Use and Editing of National Provider Identifier (NPI) Numbers Received in Electronic Data Interchange Transactions, via Direct Data Entry Screens or Paper Claim Forms, and MM4293 (http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM4293.pdf) titled Revised CMS-1500 Claim Form, which describes the revision of claim form CMS-1500 (12-90) to accommodate the reporting of the National Provider Identifier (NPI) and renamed CMS-1500 (08-05).

The official instruction, CR5584, issued to your carrier, intermediary, RHHI, A/B MAC and DME MAC regarding this change may be viewed at http://www.cms.hhs.gov/Transmittals/downloads/R222PI.pdf on the CMS Web site.

If you have any questions, please contact your Medicare carrier, intermediary, RHHI, A/B MAC, or DME MAC at their toll-free number, which may be found on the CMS Web site at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip.

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Laboratory and Radiology: Adjustment to Medicare System Common Working File (CWF) Duplicate Claim Edit for the Technical Component (TC) of Radiology and Pathology Laboratory Services Provided to Hospital Patients

Note: This article was revised on September 27, 2007, to include the “bold and italicized” language in the “GO Light” section on page 2. Basically, this added language just reminds affected providers of the need to resubmit certain claims on or after October 1, 2007. All other information remains the same.

News Flash – The Centers for Medicare & Medicaid Services (CMS) is pleased to announce that reporting for the 2007 PQRI on claims for dates of service as of July 1, 2007, has begun. Eligible professionals can now start participating in the PQRI by simply reporting the appropriate quality measure data on claims submitted to their Medicare claims processing contractor. Remember, all your informational needs can be met by visiting the PQRI Web site at http://www.cms.hhs.gov/PQRI. Here you will find educational resources, including the PQRI Tool Kit, and links to our most Frequently Asked Questions (FAQs).

Provider Types Affected
Radiology suppliers, clinical diagnostic laboratories, and other providers billing Medicare carriers or Part A/B Medicare Administrative Contractors (A/B MACs) for the TC of radiology and pathology services provided to Medicare fee-for-service hospital inpatients.

Provider Action Needed

STOP – Impact to You
Previously the Centers for Medicare & Medicaid Services (CMS) issued Change Request (CR) 5347 that established duplicate claims edits, which included consideration of the admission and discharge dates of a hospital stay in identifying duplicate claims for radiology and pathology services.

CAUTION – What You Need to Know
Effective with implementation of CR5675 on October 1, 2007, claims with dates of service on or after
April 1, 2007, will be paid that provide radiology and pathology services to Medicare beneficiaries on the day of admission and the day of discharge during an inpatient hospital stay.

GO – What You Need to Do
Make certain that your billing staffs are aware of these changes. If providers, radiology suppliers, or clinical diagnostic laboratories had claims with dates of service on or after April 1, 2007, that would have been paid had these edits been in place on April 1, 2007, they should resubmit those claims on or after October 1, 2007. Medicare carriers and A/B MACs will be ready to process resubmitted claims using these new edits as of October 1, 2007. Claims resubmitted on or after October 1, 2007, will not deny as duplicates, since they were not paid initially. For information regarding recoupment/demand letters, see Chapter 4, Section 90.2 of the Medicare Financial Management Manual located at http://www.cms.hhs.gov/manuals/downloads/fin106c04.pdf on the CMS Web site.

Background
This CR is being implemented to avoid denying claims that were legitimately provided to beneficiaries on the admission and discharge dates. The general rule is that the technical component (TC) of radiology services provided during an inpatient stay may be billed only by the admitting hospital. Radiology suppliers that render services to beneficiaries in an inpatient stay may not bill the Medicare carrier for the technical portion of the service.

Also, the TC of physician pathology services provided to a hospital inpatient may be billed only by the admitting hospital. Independent laboratories have been instructed that they may not bill for these services after December 31, 2007 per CR 5468 (Transmittal 1148, issued Jan 5, 2007). The exception is that imaging and pathology services performed on the admission date and discharge date by entities other than the admitting hospital are separately payable.

Also, note that carriers and A/B MACs will not reprocess claims already processed, but they will adjust previously processed claims if affected providers bring such claims to the attention of their carrier or A/B MAC.

Additional Information
For complete details regarding this Change Request (CR) please see the official instruction (CR5675) issued to your Medicare carrier or A/B MAC. That instruction may be viewed by going to
http://www.cms.hhs.gov/Transmittals/downloads/R1295CP.pdf on the CMS Web site.

If you have questions, please contact your Medicare carrier or A/B MAC, at their toll-free number which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

CR 5347 implemented a process to prevent payments of the TC of radiology services furnished to an inpatient of a hospital by any entity other than the admitting hospital. This CR may be reviewed by clicking on http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5347.pdf on the CMS Web site.

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Lumbar Artificial Disc Replacement (LADR)

Note: This article was revised on September 24, 2007, to reflect that CMS issued a second transmittal for CR5727. The second transmittal, R1340CP, contained revisions to the Medicare Claims Processing Manual that reflect the same information contained in the original article.

News Flash - Rejected Claims Reminder
Fee-for-Service Medicare claims can be rejected by Medicare contractors (carriers, intermediaries (FIs), and Medicare Administrative Contractors (MACs)) for a variety of reasons including: incorrect billing information, terminated provider, the beneficiary is not eligible for Medicare, or the claim was sent to the wrong contractor. If a provider has questions about a claim rejected by an FI/carrier or MAC, the provider should contact the contractor directly. It is never appropriate to direct the beneficiary who received the service billed on the claim to the 1.800.Medicare toll free line to resolve a claim rejection.

Provider Types Affected
All physicians, hospitals, and providers who submit claims to Medicare contractors (Carriers, Medicare Administrative Contractors (A/B MACs), or Medicare Fiscal Intermediaries (FIs)) for LADR provided to Medicare beneficiaries.

Provider Action Needed

STOP – Impact to You
This article is based on Change Request (CR) 5727 that summarizes a national coverage analysis for the reconsideration of the national coverage determination (NCD) for LADR.

CAUTION – What You Need to Know
Effective for dates of service on or after August 14, 2007, LADR is NOT COVERED for Medicare beneficiaries over 60 years of age.

GO – What You Need to Do
Make certain your billing staffs are aware of this change and that you issue the appropriate liability notices to beneficiaries in advance of the procedure consistent with Chapter 30 of the Medicare Claims Processing Manual at http://www.cms.hhs.gov/manuals/downloads/clm104c30.pdf on the CMS Web site. Providers should make certain to issue the Advanced Beneficiary Notice (ABN) and/or (as appropriate) the Hospital Issued Notice of Noncoverage (HINN) to the beneficiary over the age of 60 years who chooses to have LADR.

Background
On November 28, 2006, the Centers for Medicare and Medicaid Services (CMS) initiated a national coverage analysis for the reconsideration of the NCD on LADR. The original NCD for LADR was focused on a specific lumbar artificial disc implant (ChariteTM) because it was the only one with FDA approval at that time. In the original decision memorandum for LADR, CMS stated that when another lumbar artificial disc received FDA approval CMS would reconsider the policy. Subsequently, another lumbar artificial disc, ProDisc®-L, received FDA approval, which initiated the reconsideration of the NCD on LADR. After reviewing the evidence, CMS is convinced that indications for the procedure of LADR exclude the over age 60 populations; therefore, the revised NCD addresses the procedure of LADR rather than LADR with a specific manufactures implant.

Key Points

Additional Information
For complete details regarding this Change Request (CR) please see the official instruction (CR5727) issued to your Medicare FI, carrier, or A/B MAC. CR5727 contains two transmittals, one for the NCD and one for the revised Medicare Claims Processing Manual instructions. These two transmittals may be viewed by going to http://www.cms.hhs.gov/Transmittals/downloads/R75NCD.pdf and http://www.cms.hhs.gov/Transmittals/downloads/R1340CP.pdf, respectively, on the CMS Web site.

If you have questions, please contact your Medicare FI, carrier, or A/B MAC at their toll-free number which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.


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Magnetic Resonance Imaging (MRI) Procedures

News Flash - A new preventive services brochure entitled Cancer Screenings, ICN# 006434, is now available on the Centers for Medicare & Medicaid Services (CMS) Medicare Learning Network (MLN). This tri-fold brochure provides health care professionals with an overview of Medicare’s coverage of the following screening services: mammography, colorectal, prostate, Pap test, and pelvic exam. The brochure is available at http://www.cms.hhs.gov/MLNProducts/downloads/Cancer_Screening.pdf on the CMS Web site.

Provider Types Affected
Independent diagnostic testing facilities and other providers submitting claims to Medicare carriers, Fiscal Intermediaries (FIs) and Part A/B Medicare Administrative Contractors (A/B MACs) for MRI services provided to Medicare beneficiaries.

Provider Action Needed

STOP – Impact to You
Effective January 1, 2007, separate payment is made for the contrast media used in various imaging procedures. The cost of the contrast media is no longer included in the practice expense (PE) relative values units (RVUs) for the procedures.

CAUTION – What You Need to Know
In addition to the Current Procedural Terminology (CPT) code representing the imaging procedure, the appropriate Healthcare Common Procedure Coding
System (HCPCS) “Q” code (Q9945-Q9954; Q9958-Q9964) can be separately billed and paid for the contrast medium utilized in performing the service.

GO – What You Need to Do
Make certain that your billing staffs are aware of these changes. See the Background and Key Points sections of this article for further information.

Background and Key Points
Prior to January 1, 2007, separate payment was not made for contrast media used in certain MRI procedures because the contrast media was included in the payment for the procedure. To read the complete change in the Medicare Claims Processing Manual, Chapter 13—Radiology Services and Other Diagnostic Procedures, see the Additional Information section of this article and click on the official instruction that was issued with CR5677. The key points of CR5677 are:

Additional Information
For complete details regarding this Change Request (CR) please see the official instruction (CR5677) issued to your Medicare carrier, FI or A/B MAC. That instruction may be viewed by going to http://www.cms.hhs.gov/Transmittals/downloads/R1339CP.pdf on the CMS Web site.

If you have questions, please contact your Medicare carrier, FI or A/B MAC, at their toll-free number
which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

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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. Providers may submit questions to the Web site at
http://www.cignagovernmentservices.com/medicare_dynamic/customer_service/index.html

  1. Certified Diabetes Educators and Diabetes Self Management Training (DSMT)
    Question: How do they bill for this?
    Answer: DSMT is billed using HCPCS code G0108 and G0109. DSMT can be furnished by anyone who qualifies for direct payment for services done by Medicare and meets the definition of certified provider as stated in CMS Publication 100-2, the Medicare Benefit Policy Manual, Chapter 15, section 300.2:
    http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf

The services of a certified diabetes educator (CDE) could be billed as part of an accredited DSMT program or if he/she is eligible for direct payment from Medicare (for example, a nurse practitioner who is also a certified diabetes instructor). A CDE that is not able to directly bill Medicare could not do DSMT as an “incident to” service to a physician billed either as DSMT or as an E&M visit (i.e. either service billed under the physician’s number). If ancillary staff provides Diabetes training in the course of an office visit, it is considered bundled into a medically necessary E&M visit provided by the billing physician that same date. If the only reason for the encounter was Diabetes training by the ancillary staff in an office setting, then the only code billable for this would be 99211. We have seen errors such as providers billing, e.g., the highest level office visit, CPT code 99215, for visits only between the patient and a CDE on staff and billed under the physician’s number

Additional information on this service (including eligible beneficiaries, individual training, etc.) can be found in sections 300-300.501 in the same cite above. Also, CMS Publication 100-4, the Medicare Claims Processing Manual, Chapter 18, beginning with section 120 details coding, payment and frequency and is accessible via the following:
http://www.cms.hhs.gov/manuals/downloads/clm104c18.pdf

  1. Fracture care in the Emergency Room
    Question: How should ER doctors bill for splinting/casting of patients with fractures that are referred to orthopedists?
    Answer: If the ER doctor is only applying a cast or strapping to stabilize or protect a fracture, injury, or dislocation and/or to afford comfort to a patient, then the code billed should be from the “Application of Casts and Strapping” section of the CPT Manual including CPT Codes 29000-29590. Furthermore, if the ER physician does not perform any restorative treatment nor plans on providing subsequent fracture care, then the ER physician should bill only the appropriate casting/strapping code and not a code for co-managed fracture care (e.g. CPT code 25600 + modifier 54). The ER physician may also report the appropriate level of E/M with the -25 modifier appended if the key components for the Evaluation and Management (E/M) service is met. The orthopedist should then be able to bill the fracture care code globally.
  2. Robotic assisted surgery
    Question: Does Medicare pay for robotic assistance?
    Answer: No additional payment would be made beyond reimbursement for the CPT surgery code. For example, we would not pay any differently for an oophorectomy w/robotic assistance as compared to an open or laparoscopic oophorectomy.
  3. Outsourcing of radiology services outside the United States
    Question: Can Medicare be billed for these circumstances?
    Answer: Medicare cannot be billed in this case. CMS Publication 100-2, the Medicare Benefit Policy Manual, Chapter 16, section 60 states:

“Payment may not be made for a medical service (or a portion of it) that was subcontracted to another provider or supplier located outside of the United States. For example, if a radiologist who practices in India analyzes imaging tests that were performed on a beneficiary in the United States, Medicare would not pay the radiologist or the U.S. facility that performed the imaging test for any of the services that were performed by the radiologist in India”.

There is also a Medicare Learning Network Matters article published this year by the Center for Medicare
and Medicaid Services available through the following link:http://www.cms.hhs.gov/MLNMattersArticles/
downloads/MM5427.pdf

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Medicare Appeals Process

Once an initial claim determination is made through the Comprehensive Error Rate Testing (CERT) Program providers have the right to appeal the CERT decision through the Medicare Appeals Process.

What is the Medicare Appeals Process?

There are Five Levels of the Medicare Appeals Process

Redeterminations
A request for a redetermination must be filed either on Form CMS-20027 or in writing. To link to this form, scroll down to “Related Links” A written request not made on Form CMS-20027 must include the following information:

The appellant should attach any supporting documentation to their redetermination request. The Carrier will generally issue a decision (either in a letter, a revised remittance advice, or a Medicare Summary Notice) within 60 days of receipt of the redetermination request.

Note: Carriers can no longer correct minor errors and omissions on claims through the appeals process. For information on how to correct minor errors and omissions, please scroll down to Correcting Minor Errors below.

Reconsideration
A written reconsideration request must be filed with a QIC within 180 days of receipt of the redetermination. To request a reconsideration, follow the instructions on your Medicare Redetermination Notice (MRN). A request for a reconsideration may be made on the standard form CMS-20033. This form is mailed with the MRN. If the form is not used, the written request must contain all of the following information:

The request should clearly explain why you disagree with the redetermination. A copy of the MRN and any other useful documentation should be sent with the reconsideration request to the appropriate QIC. Documentation that is submitted after the reconsideration request has been filed, may result in an extension of the timeframe a QIC has to complete its decision. Further, the reconsideration request must contain any evidence noted in the redetermination as missing and any other evidence relevant to the appeal. However, it is not necessary to resubmit information that was already submitted to the contractor that made the redetermination. Evidence not submitted at the reconsideration level may be excluded from consideration at subsequent levels of appeal unless you show good cause for not submitting the evidence.

Reconsideration Decision Notification
Generally, the QIC will send its decision to all parties within 60 days of receipt of the request for reconsideration. The decision will contain detailed information on further appeals rights if the decision is not fully favorable. If the QIC cannot complete its decision in the applicable timeframe, it will inform the appellant of their right to escalate the case to an Administrative Law Judge.

ALJ Hearing
Refer to the reconsideration decision letter from the QIC for details regarding the procedures for requesting an ALJ hearing. The standard form CMS-20034 A/B may be used to file a request for an ALJ hearing.

ALJ hearings are generally held by video-teleconference (VTC) or by telephone. If you do not want a VTC or telephone hearing, you may ask for an in-person hearing. An appellant must demonstrate good cause for requesting an in-person hearing, and the ALJ will determine whether an in-person hearing is warranted on a case-by-case basis. Appellants may also ask the ALJ to make a decision without a hearing (on-the-record). Hearing preparation procedures are set by the ALJ. CMS or its contractors may become a party to, or participate in, an ALJ hearing after notifying all parties to the hearing.

The ALJ will generally issue a decision within 90 days of receipt of the hearing request. This timeframe may be extended for a variety of reasons including, but not limited to:

If the ALJ cannot issue a decision in the applicable timeframe, the ALJ will notify the appellant of their right to escalate the case to the Departmental Appeals Board (DAB).

Please note that the amount in controversy required to request an ALJ hearing is increased annually by the percentage increase in the medical care component of the consumer price index for all urban consumers. The amount in controversy for 2007 is $110.

Departmental Appeals Board (DAB)
Refer to the ALJ decision for details regarding the procedures to follow when filing a request for DAB review.

Generally, the DAB will issue a decision within 90 days of receipt of a request for review. That timeframe may be extended for various reasons, including but not limited to, the case being escalated from the ALJ level.

U.S. District Court Review
The DAB’s decision will contain information about the procedures for requesting U.S. District Court Review.

Please note that the amount in controversy required to request a judicial review is increased annually by the percentage increase in the medical care component of the consumer price index for all urban consumers. The amount in controversy for 2007 is $1,130.

Correcting Minor Errors:
For situations that fall into the category of a minor error/omission, the provider should request a Reopening. This Reopening Request must be made within one year from the date of notice of the initial determination. A Reopening must state the reason the inquiry is being sent to the Medicare office and can be submitted on the Written Adjust form (see link under Related Links). Below are some examples of requests that may be resubmitted as Reopenings:

Related Links:
Centers for Medicare & Medicaid Services (CMS) Original Medicare (Fee-for-service) Appeals
http://www.cms.hhs.gov/OrgMedFFSAppeals/06_Review%20Federal%20District%20Court.asp#TopOfPage

CIGNA Government Services
http://www.cignagovernmentservices.com

Redetermination Request Form
http://www.cignagovernmentservices.com/partb/pubs/news/2007/0807/cope6337.html

Medicare Part B Reopenings Adjustment Request Form
http://www.cignagovernmentservices.com/partb/forms/pdf/GEN_reopenings_adjust.pdf

Please mail your Redeterminations request to the following PO Boxes:

Idaho
CIGNA Government Services
Attn: Redeterminations
PO Box 22990
Nashville, TN 37202

Tennessee
CIGNA Government Services
Attn: Redeterminations
PO Box 23950
Nashville, TN 37202

North Carolina
CIGNA Government Services
Attn: Redeterminations
PO Box 24770
Nashville, TN 37202

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Medicare Clinical Trial Policy (CTP)

News Flash - Since May 29, 2007, Medicare Fiscal Intermediaries, as well as Part B CIGNA Idaho and Tennessee, have been validating National Provider Identifiers (NPIs) and Legacy Provider Identifier pairs submitted on claims against the Medicare NPI Crosswalk. Between the period of September 3, 2007, and October 29, 2007, all other Part B carriers and DME MACS will begin to turn on edits to validate the NPI/Legacy pairs submitted on claims. If the pair is not found on the Medicare NPI crosswalk, the claim will reject. Medicare contractors have been instructed to inform providers at a minimum of seven days prior to turning on the edits to validate the NPI/Legacy pairs against the Crosswalk.

Provider Types Affected
All physicians, providers, and suppliers who submit claims related to clinical trials to Medicare contractors (carriers, Medicare Administrative Contractors (A/B MACs), durable medical equipment Medicare Administrative Contractors (DME/MACs), fiscal intermediaries (FIs), and regional home health intermediaries (RHHIs)).

Provider Action Needed

STOP – Impact to You
This article is based on Change Request (CR) 5719, which implements two changes to the 2000 clinical trial policy by: (1) modifying for clarity the language describing coverage of an investigational item/service in the context of a clinical trial, and, (2) adopting coverage with evidence development (CED). The remainder of the 2000 clinical trials policy continues without change.

CR 5719 states that for items and services furnished on and after July 9, 2007, the routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial. The investigational item or service itself is excluded, unless otherwise covered outside of the clinical trial.

CAUTION – What You Need to Know
In addition, the National Coverage Determination (NCD) is revised to add coverage with evidence development (CED). CED is for items and services in clinical research trials for which there is some evidence of significant medical benefit, but for which there is insufficient evidence to support a “reasonable and necessary” determination. CED is determined through the NCD process, and conditional upon meeting standards of patient safety and clinical evidence, items and services not otherwise covered would be considered “reasonable and necessary” in the context of a clinical trial. Coverage determined under CED is implemented via subsequent NCDs, CRs, and MLN Matters articles specific to the coverage issue.

GO – What You Need to Do
Make certain your billing staffs are aware of these changes. Medicare contractors will adjust claims processed prior to the implementation date of this change if you bring such claims to their attention.

Background
On June 7, 2000, the President of the United States issued an executive memorandum directing the Secretary of Health and Human Services to “explicitly authorize [Medicare] payment for routine patient care costs and costs due to medical complications associated with participation in clinical trials.” In keeping with the President’s directive, the Centers for Medicare & Medicaid Services (CMS) engaged in defining the routine costs of clinical trials and identifying the clinical trials for which payment for such routine costs should be made. On September 19, 2000, CMS implemented its initial Clinical Trial Policy through the NCD process. On July 10, 2006, CMS opened a reconsideration of its NCD on clinical trials in the NCD Manual, section 310.1. CR5719 communicates the findings resulting from that analysis.

Additional Information
To see the official instruction (CR5719) issued to your Medicare FI, carrier, DME/MAC, RHHI or A/B MAC, visit http://www.cms.hhs.gov/transmittals/downloads/R74NCD.pdf on the CMS Web site.

If you have questions, please contact your Medicare FI, carrier, DME/MAC, RHHI or A/B MAC at their toll-free number, which may be found at:
http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

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New Remark Code for Denying Separately Billed Services

Note: This article was revised on September 10, 2007, to reflect that CR5659 was revised. The CR transmittal number (see above) and the Web address for accessing CR5659 were revised. All other information remains the same.

News Flash – New Medicare Learning Network (MLN) Catalog Available!
The August 2007 edition of the MLN Products Catalog is now available - the MLN Products Catalog s an interactive downloadable document that lists all Medicare Learning Network products by media format. The catalog has been revised to provide new customer-friendly links that are embedded within the document. All product titles and the word “download” when selected, will link you to the online version of the product. The word “hard copy” when selected, will automatically link you to the MLN Product Ordering page. To access the catalog, visit http://www.cms.hhs.gov/MLNGENINFO on the CMS Web site.

Provider Types Affected
Medicare providers who submit claims to Medicare Part A/B Medicare Administrative Contractors (A/B MACs) or carriers for ambulance services rendered to Medicare beneficiaries.

Provider Action Needed
Be aware that contractors will use a new Remittance Advice Remark Code (RARC) message when denying ambulance claims submitted with a code(s) that is not separately billable and already included in the base rate. For claims submitted by ambulance suppliers that Medicare processes on or after October 1, 2007, and which Medicare denies because the code for the service does not appear on the Ambulance Fee Schedule, Medicare will return the RARC of N390 to show “This service cannot be billed separately.” See the remainder of this article for further details.

Key Points of CR5659

Background
CR5659 is the official document that announces these changes in Medicare processes and states that effective January 1, 2006, items and services which include but are not limited to oxygen, drugs, extra attendants, supplies, EKG, and night differential are no longer paid separately for ambulance services. This occurred when the Centers for Medicare & Medicaid Services (CMS) fully implemented the Ambulance Fee Schedule. Therefore, payment is based solely on the Ambulance Fee Schedule amount as cited in 42 CFR § 414.615 (e) and such payment represents payment in full for all services, supplies, and other costs for an ambulance service furnished to a Medicare beneficiary. CMS was made aware that some providers are submitting claims with ancillary services that are included in the base rate.
CMS decided that a clearer denial message was needed to explain the reason for the denial and that this service is not separately billable and as a result, these claims/services should not be resubmitted. This is true whether the primary transportation service is allowed or denied. Remember that when these services are denied, the services are not separately billable to the beneficiaries.

Additional Information
For complete details regarding this Change Request (CR) please see the official instruction (CR5659) issued to your Medicare carrier or A/B MAC. That instruction may be viewed by going to http://www.cms.hhs.gov/Transmittals/downloads/R1333CP.pdf on the CMS Web site.

If you have questions, please contact your Medicare carrier or A/B MAC, at their toll-free number, which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

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New Waived Tests

News Flash - Flu Season is upon us! Begin now to take advantage of each office visit as an opportunity to talk with your patients about the flu virus and their risks for complications associated with the flu. Encourage them to get their flu shot. It’s their best defense against combating the flu this season. (Medicare provides coverage of the flu vaccine without any out-of-pocket costs to the Medicare patient. No deductible or copayment/coinsurance applies.) And don’t forget, health care professionals need to protect themselves also. Get Your Flu Shot – Not the Flu. Remember – Influenza vaccination is a covered Part B benefit. Note that influenza vaccine is NOT a Part D covered drug. For information about Medicare’s coverage of flu vaccine and its administration as well as related educational resources for health care professions, please go to http://www.cms.hhs.gov/MLNProducts/Downloads/flu_products.pdf on the CMS Web site.

Provider Types Affected
Physicians, providers, and suppliers submitting claims to Medicare carriers and/or Part A/B Medicare Administrative Contractors (A/B MACs) for services provided to Medicare beneficiaries

Provider Action Needed
This article is based on Change Request (CR) 5715 which informs carriers and A/B MACS of new waived tests approved by the Food and Drug Administration (FDA) under Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Background
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a facility to be appropriately certified for each test they perform. Laboratory claims are currently edited at the CLIA certificate level in order to ensure that the Centers for Medicare & Medicaid Services (CMS) only pays for laboratory tests categorized as waived complexity under CLIA (for facilities with a CLIA certificate of waiver).


New waived tests are approved by the FDA on a flow basis, and the tests are valid as soon as they are approved. The new waived tests announced by CR5715 are in the following table:

CPT Codes Effective Date Description
83001QW October 21, 2003 Genosis Fertell Female Fertility Test
84443QW April 2, 2007 Jant Pharmacal Accutest TSH {Whole Blood}
86308QW April 12, 2007 Signify Mono Whole Blood
86308QW April 12, 2007 Clearview MONO Whole Blood
82465QW, 83718QW, 84460QW, 80061QW, 84478QW May 16, 2007 Cholestech LDX (Lipid Profile – ALT (GPT)){Whole Blood}
86318QW May 16, 2007 Immunostics Detector H. Pylori WB (H. pyloi Antibody Test) {Whole Blood}
86308QW May17, 2007 Immuno Detector Mono {Whole Blood}
80101QW May 24, 2007 Innovacon Multi-Clin Drug Screen Test Device
80101QW May 24, 2007 Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
87880QW May 24, 2007 Cardinal Health SP Brand Rapid Test Strep A Dipstick (K010582/A028)
86318QW May 24, 2007 Cardinal Health SP Brand Rapid Test H. pylori {Whole Blood}(K024350/A15)
82042QW, 82310QW, 82565QW, 82947QW, 82950QW, 82951QW, 82952QW, 84520QW May 31,2007 Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1)
{Whole Blood}
86308QW May 31, 2007 Cardinal Health SP Brand Rapid Test Mono {Whole Blood}
82247QW, 84075QW, 84157QW, 84450QW, 84460QW May 31, 2007 Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 2)
{Whole Blood}
A86318QW June 11, 2007 Fisher Healthcare Sure-Vue H. pylori Test {Whole Blood}
89321QW June 18, 2007 Fertell Male Fertility Test

Note: The Current Procedural Terminology (CPT) codes for these new waived tests must have the modifier QW to be recognized as a waived test.

Also, the new waived CPT/HCPCS code, 82310QW, has been assigned for the total calcium test performed using the Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}. The new waived CPT/HCPCS code, 82565QW, has been assigned for the creatinine test performed using the Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}. The new waived CPT/HCPCS code, 89321QW, has been assigned for the semen motility test performed using the Fertell Male Fertility Test.

Your Medicare carrier or MAC will not automatically adjust claims processed prior to the implementation of these changes. However, they will adjust such claims that you bring to their attention.

Additional Information
For complete details, please see the official instruction, CR5715, issued to your carrier or A/B MAC regarding this change. That instruction may be viewed at
http://www.cms.hhs.gov/transmittals/downloads/R1346CP.pdf on the CMS Web site. The attachment to CR 5715 includes the list of tests granted waived status under CLIA, and the tests mentioned on the first page of the attachment (i.e., CPT codes: 81002, 81025, 82270, 82272, G0394, 82962, 83026, 84830, 85013, and 85651) do not require a QW modifier to be recognized as a waived test.

If you have questions, please contact your Medicare carrier or A/B MAC at their toll-free number, which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

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New Web Site for Approved Transplant Centers

News Flash – The revised Sole Community Hospital Fact Sheet (March 2007), which provides information about Sole Community Hospital classification and payments, is now available in print format from the Centers for Medicare & Medicaid Services Medicare Learning Network. To place your order, visit
http://www.cms.hhs.gov/mlngeninfo, scroll down to “Related Links Inside CMS,” and select “MLN Product Ordering Page.”

Provider Types Affected
All hospital transplant programs that submit claims to Medicare administrative contractors (A/B MACs), carriers or fiscal intermediaries (FIs), for organ transplants provided to Medicare beneficiaries.

Provider Action Needed

STOP – Impact to You
This article is based on Change Request (CR) 5724, which states that on March 30, 2007, the Department of Health and Human Services (DHHS) established a regulation authorizing the survey and certification of transplant programs.

CAUTION – What You Need to Know
All hospital transplant programs covered by the regulation, whether currently approved by the Centers for Medicare & Medicaid Services (CMS) or seeking initial approval, must submit a request for approval under the new regulations to CMS by December 26, 2007 (180 days from the effective date of the regulation). Those programs that were already Medicare approved for participation at the time of the effective date (June 28, 2007) of the regulation will continue to be covered under National Coverage Determination (NCD) or End-stage renal disease (ESRD) conditions for coverage (as applicable) until they are notified in writing by CMS of their approval or denial under the new regulations.

GO – What You Need to Do
BE sure to submit your request for approval by December 26, 2007, and see the Background/Key Points section of this article for further details. The specific manual sections that relate to this article are attached to CR5724, which is available at the Web address listed in the Additional Information section of this article.

Background/Key Items
CMS is the federal agency responsible for monitoring compliance with the Medicare conditions of participation for transplant hospitals. CMS will review the information transplant hospitals submit and conduct onsite surveys as necessary to determine compliance with the conditions of participation. Transplant programs must be in compliance with the conditions of participation to continue Medicare approval or to receive initial approval for participation.

Additional Information
For complete details regarding this Change Request (CR) please see the official instruction (CR5724) issued to your Medicare FI, carrier, or A/B MAC. That instruction may be viewed by going to http://www.cms.hhs.gov/Transmittals/downloads/R1341CP.pdf on the CMS Web site.

If you have questions, please contact your Medicare FI, carrier, or A/B MAC at their toll-free number which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

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Notification of the 2008 Physician Election Period for the Part B Drug Competitive Acquisition Program (CAP)

News Flash - Rejected Claims Reminder - Fee-for-Service Medicare claims can be rejected by Medicare contractors (carriers, fiscal intermediaries (FIs), and Medicare Administrative Contractors (MACs)) for a variety of reasons including: incorrect billing information, terminated provider, the beneficiary is not eligible for Medicare or the claim was sent to the wrong contractor. If a provider has questions about a claim rejected by an FI/carrier or MAC, the provider should contact the contractor directly. It is never appropriate to direct the beneficiary who received the service billed on the claim to the 1.800.Medicare toll free line to resolve a claim rejection.

Provider Types Affected
Physicians participating in the CAP for Part B Drugs and Biologicals and physicians who would like to participate in the program during 2008.

Provider Action Needed

STOP – Impact to You
The Centers for Medicare & Medicaid Services (CMS) will hold the 2008 Part B Drug Competitive Acquisition Program (CAP) physician election period beginning on October 1, 2007 and concluding on November 15, 2007. Current participating CAP physicians must re-elect for the 2008 year if they would like to remain in the program. Interested Medicare physicians may elect to participate in CAP during this timeframe as well. New Medicare physicians may submit an application for CAP during the fall election period or anytime within 90 days from their enrollment into Medicare.

CAUTION – What You Need to Know
To participate in CAP in 2008, go to the CAP Web site and view the CAP drug list. Download the Physician 2008 Election Agreement Form, complete the form, and submit it to your local Medicare carrier or Medicare Administrative Contractor (A/B MAC). All submissions must be postmarked by November 15, 2007. The 2008 Physician Election Agreement will be effective January 1, 2008 through December 31, 2008.

GO – What You Need to Do
Read on for further details.

Background
This article contains information about the Competitive Acquisition Program (CAP). The CAP is mandated by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA, Section 303 (d)), which requires the implementation of a CAP for Medicare Part B drugs and biologicals not paid on a cost or prospective payment system basis. You can review the MMA, Section 303(d) at http://www.cms.hhs.gov/CompetitiveAcquisforBios/Downloads/303d.pdf on the CMS Web site.

CAP is an alternative to the Average Sales Price (ASP) system of obtaining drugs for Medicare. The CAP is open to Medicare physicians who administer drugs under the “incident to” provision in their offices.

The term “physician” includes individuals who are authorized to provide services under the Social Security Act and who can, within their State’s scope of practice, prescribe and order drugs covered under Medicare Part B. Physicians can buy and bill drugs under the Average Sales Price (ASP) system or, through CAP, obtain drugs from an Approved CAP Vendor that has been selected in a competitive bidding process.

The CAP drug list includes nearly 190 injectable and infused Part B drugs. A list of the CAP drugs is available in the Downloads section of the following CMS CAP Web page: http://www.cms.hhs.gov/CompetitiveAcquisforBios/15_Approved_Vendor.asp. Be sure to select the most recent list of drugs.

This article announces the 2008 annual physician election period.

Annual CAP Physician Election
The 2008 annual fall physician election period for CAP will begin on October 1, 2007 and will conclude on November 15, 2007. To begin participating in CAP effective January 1, 2008, the 2008 Physician Election Agreement Form must be postmarked by November 15, 2007 and mailed to your local carrier. Please do not mail election forms before October 1, 2007.

Current participating CAP physicians must re-elect yearly during the annual fall election period if they wish to continue participating in CAP. New Medicare physicians have 90 days to elect into the CAP.

Physicians who are not currently participating in CAP and who do not wish to participate in CAP at this time are not required to take any action.

Physicians/groups must return a completed CAP Physician Election Agreement form by mail to their local carrier or A/B MAC. Include “ATTENTION: CAP PHYSICIAN ELECTION” in the address. The address for your local Medicare carrier or A/B MAC may be found at http://www.cms.hhs.gov/MedicareProviderSupEnroll/Downloads/contact_list.pdf on the CMS Web site.

Additional Information
For additional information on the election process, please review CR4404 at http://www.cms.hhs.gov/transmittals/downloads/R932CP.pdf and its related article at http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM4404.pdf on the CMS Web site.

For more information on CAP and how to elect to participate in the program, please visit the CAP Web site at http://www.cms.hhs.gov/CompetitiveAcquisforBios/02_infophys.asp#TopOfPage.

The Physician Election Guide and Physician Election Agreement Form can be found at the bottom of that page in the “Downloads” section.

Participating CAP Physicians are encouraged to join the dedicated CAP listserv, CMS-CAP-PHYSICIANS-L, in order to receive pertinent and timely information regarding the CAP program. Please view the “Related Links Inside CMS” section on the “Information for Physicians” page at http://www.cms.hhs.gov/CompetitiveAcquisforBios/02_infophys.asp on the CMS Web site.

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Payment Allowance Limits for Medicare Part B Drugs Effective April 1, 2007 through June 30, 2007

Payment Allowance Limits for Medicare Part B Drugs Effective April 1, 2007 through June 30, 2007

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Payment Allowance Limits for Medicare Part B Drugs Effective January 1, 2007 through March 31, 2007

Payment Allowance Limits for Medicare Part B Drugs Effective January 1, 2007 through March 31, 2007

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Payment Allowance Limits for Medicare Part B Drugs Effective July 1, 2007 through September 30, 2007

Payment Allowance Limits for Medicare Part B Drugs Effective July 1, 2007 through September 30, 2007

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Payment Allowance Limits for Medicare Part B Drugs Effective October 1, 2007 through December 31, 2007

Payment Allowance Limits for Medicare Part B Drugs Effective October 1, 2007 through December 31, 2007

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Percutaneous Transluminal Angioplasty (PTA)

Note: This article was revised on September 13, 2007, to reflect that CMS revised and re-issued CR5660. The CR release date, transmittal number, and the Web address for accessing CR5660 were changed. All other information remains the same.