April 2006 Part B Medicare Bulletin
Posted April 3, 2006
Table of Contents
- 2005 Revised American National Standards Institute X12N 837 Professional Health Care Claim Companion Document
- Abatacept (Orencia)
- Additional Requirements for the Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals - MMA
- Ambulance Fee Schedule - CY 2006 Update: Correction to CR 4061
- Announcement of Redesigned National Provider Identifier Web Page
- Annual Update to the Therapy Code List
- Appropriate Billing of Ambulance Services
- April 2006 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing File and Revisions to January 2005, April 2005, July 2005, October 2005, and January 2006 Quarter ASP Medicare Part B Drug Pricing Files
- April Quarterly Update to the 2006 Annual Update of HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement
- ASC Corrections for Dates of Service October 1, 2005 and Forward
- Attestation Form for Conducting Real Time Eligibility Inquiries with Medicare - Revision to Chapter 31
- Bevacizumab (Avastin) in the Treatment of Neovascular (Wet) Macular Degeneration
- Billing Requirements for Positron Emission Tomography (PET) Scans for Dementia and Neurodegenerative Diseases
- Botulinum Toxin - Revision
- Centers for Medicare & Medicaid Services (CMS) Seeks Provider Input on Satisfaction with Medicare Fee-for-Service Contractor Services
- Change in the Long Descriptor for HCPCS Code Q4080
- Change Payment Floor Date for Paper Claims
- Changes to Chapter 29 - Appeals of Claims Decisions: Redeterminations and Reconsiderations (Implementation Date May 1, 2005)- MMA
- Changes to the Laboratory National Coverage Determination (NCD) Edit Software for April 2006
- Clinical Pathology Consultations
- Collection and Verification of Ambulance Crew Member Information
- Colorectal Cancer: Preventable, Treatable, and Beatable: Medicare Coverage and Billing for Colorectal Cancer Screening
- Competitive Acquisition Program (CAP) for Part B Drugs-Coding, Testing, and Implementation - MMA
- CPT 90862 vs M0064
- Creation of a Second Participation Enrollment Period for 2006
- Eliminate the Use of Surrogate Unique Physician Identification Numbers (UPINs) on Medicare Claims
- Enactment of the Deficit Reduction Act of 2005
- Expansion of Coverage for Percutaneous Transluminal Angioplasty (PTA)
- Guidelines for Payment of Vaccine (Pneumococcal Pneumonia Virus, Influenza Virus, and Hepatitis B Virus) Administration
- HCPCS 2006 Discontinued
- Healthcare Common Procedure Coding System (HCPCS) Codes Subject to, and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits
- Hold on Medicare Payments
- Important Notice For Providers Ordering And Rendering Bone Mineral Density Testing
- Instructions for Provider Notification Regarding Streamlined Drug Coverage Materials for Health Care Professionals, a New Fact Sheet and Script for Recent Audio Conference
- Instructions for the Payment of Health Professional Shortage Area (HPSA) and Physician Scarcity Area (PSA) Bonuses When the Place of Service (POS) Is Home
- January 2006 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing File, Effective January 1, 2006, and Revisions to January 2005, April 2005, July 2005, and October 2005 Quarterly ASP Medicare Part B Drug Pricing Files
- Medical Review Frequently Asked Questions - February 2006
- Medicare Carrier Number
- Medicare Prescription Drug Coverage: Essential Information and Resources for Prescribing Health Care Professionals - The Eleventh in the Medlearn Matters Series on the New Prescription Drug Plans
- Medicare Remit Easy Print (MREP) Enhancements, and Clarification of Check Issue/Electronic Funds Transfer (EFT) Effective Date
- Medicare Remit Easy Print (MREP) Software
- Modification to QR Modifier Edit for Automatic Implantable Cardiac Defibrillator (ICD) Services
- National Provider Identifier (NPI) Stage Two for Electronic Billers
- New 2006 Payment Rate for Services Paid Under the Medicare Physician Fee Schedule
- New 2006 Payment Rate for Services Paid Under the Medicare Physician Fee Schedule (MPFS)
- New EDI Prepass Edits for NPI
- New Skilled Nursing Facility (SNF) Consolidated Billing (CB) Web Site Address
- NPI - Medicare Policy on Subpart Designation
- Provider Enrollment in the Medicare Program
- Providers Not Submitting Documentation
- Sanctioned or Excluded Providers
- Quarterly Average Sales Price Files
- Quarterly Provider Update
-
Quarterly Update to Correct Coding Initiative (CCI) Edits, Version 12.1, Effective April 1, 2006
- Remittance Advice Remark Code and Claim Adjustment Reason Code Update
- Remittance Advice Remark Code (RARC) and Claim Adjustment Reason Code (CARC) Update
- Revisions to Instructions for Contractors Other Than the Religious Nonmedical Health Care Institutions (RNHCI) Specialty Contractor Regarding Claims for Beneficiaries with RNHCI Elections
- Shared Systems Medicare Secondary Payer (MSP) Balancing Edit and Administrative Simplification Compliance Act (ASCA) Enforcement Update
- Stage 1 Use and Editing of National Provider Identifier Numbers Received in Electronic Data Interchange Transactions, via Direct Data Entry Screens, or Paper Claim Forms
- Therapy Caps Exception Process
- Therapy Cap Exception Process - Important Information for Submitting Requests
Centers for Medicare & Medicaid Services (CMS) Seeks Provider Input on Satisfaction with Medicare Fee-for-Service Contractor Services
Note: This article was revised on January 20, 2006, to show the effective and implementation dates (see above) as January 3, 2006.
Provider Types Affected
Sample of 25,000 Medicare providers served by 42 Medicare Fee-for-Service FFS) Contractors, including fiscal intermediaries (FIs), carriers, durable medical equipment regional carriers (DMERCs), and rural home health intermediaries (RHHIs)
Provider Action Needed
STOP - Impact to You
The Centers for Medicare & Medicaid Services (CMS) would like to provide a channel for you to voice your opinions about the services you receive from your Fee-for-Service (FFS) Contractors. The Medicare Contractor Provider Satisfaction Survey (MCPSS) is designed to garner quantifiable data on provider satisfaction with the performance of FFS contractors. The MCPSS is one of the tools CMS will use to carry out the measurement of provider satisfaction levels, a requirement of the Medicare Modernization Act (MMA). Specifically, the survey will enable CMS to gauge provider satisfaction with key services performed by the 42 contractors that process and pay the more than $280 billion in Medicare claims each year. Those Medicare contractors will use the results to improve service. CMS will use the results to improve its oversight of and increase the efficiency of the administration of the Medicare program.
CAUTION - What You Need to Know
The first national implementation of the MCPSS will begin January 3, 2006. If you have been selected, you will receive a notification packet in the mail with background information about the survey, as well as an instruction sheet with information on how to access and complete the survey instrument via a secure Internet Web site. The letter will also include a phone number that you can call to request a paper copy of the survey instrument to submit your responses by mail or fax, if you prefer to do so.
GO - What You Need to Do
Be alert for a notification packet in the mail. If you are selected and receive the notification packet, please take the time to complete and submit your survey responses as soon as possible. The data collection period will continue through January 25, 2006.
Background
The 2006 survey will query approximately 25,000 randomly selected providers-those physicians, healthcare practitioners, and facilities that serve Medicare beneficiaries across the country-on the seven key areas of the provider contractor interface:
- Provider communications
- Provider inquiries
- Claims processing
- Appeals
- Provider enrollment
- Medical review
- Provider audit and reimbursement
It contains a total of 76 questions and takes approximately 21 minutes to complete. The deadline for survey submission is January 25, 2006. CMS will analyze the data and release a summary report in July that will be made available on the Internet. Each contractor will also receive an individual report on their performance in June. The MCPSS will be conducted on an annual basis. CMS has awarded a contract to Westat, a survey research firm, to administer the MCPSS.
Additional Information
For questions or additional information about the MCPSS, please visit http://www.cms.hhs.gov/MCPSS/ on the CMS Web site.
Attestation Form for Conducting Real Time Eligibility Inquiries with Medicare - Revision to Chapter 31
Note: This article was revised on January 31, 2006, to change the effective date (shown above) from
October 1, 2006, to October 1, 2005. All other information remains the same.
Provider Types Affected
Providers who access the 270/271 health care eligibility inquiry and response application in real time
Provider Action Needed
STOP - Impact to You
Beginning September 1, 2005, an on-line attestation form (Trading Partner Agreement for Submission of 270s to Medicare on a Real-Time Basis) must be completed by submitters authenticated by the Centers for Medicare & Medicaid Services (CMS) to conduct 270/271 transactions with CMS before providers may access the real-time 270/271 health care eligibility inquiry and response application.
CAUTION - What You Need to Know
Submitters requesting access to the Medicare beneficiary database must follow the procedure outlined in the Additional Information section below.
GO - What You Need to Do
Please be sure to fill out this new agreement form located at http://www.cms.hhs.gov/it so you can conduct 270/271 transactions with Medicare.
Background
The purpose of Change Request (CR) 4093 is to alert Medicare providers to the revision in the Medicare Claims Processing Manual, Chapter 31 (ANSI X12N Formats Other than Claims or Remittance).
This revision addresses the standards for Medicare beneficiary eligibility inquiries, and creates the database and infrastructure needed to provide a real-time, centralized Health Insurance Portability and Accountability Act (HIPAA) compliant Health Care Eligibility Benefit Inquiry and Response transaction (270/271).
Additional Information
Access Process for Clearinghouses/Provider Beginning September 1, 2005:
- The Medicare Eligibility Integration Contractor (MEIC) will e-mail the on-line attestation form outlining security and privacy procedures for submitters already submitting authenticated 270 transactions on a real time basis.
- Each Submitter should complete the form in its entirety and transmit it back via e-mail to MCAREHD@emdeon.com.
Beginning October 1, 2005:
- Submitters will be able to access the appropriate forms for the CMS 270/271 Medicare Eligibility transaction at: http://www.cms.hhs.gov/AccessToDataApplication
- The submitter must provide the information requested on the form electronically and click on the appropriate assurances. If the submitter does not consent to the terms of the agreement, by appropriately completing the form, the access process will be terminated.
- A copy of the appropriately completed form must be electronically submitted to CMS. Once CMS has the completed form, it will be authenticated, at which time the submitter will then be directed to complete an Medicare Data Communications Network (MDCN) connectivity form and submit it electronically in order to be connected to the 270/271 eligibility database.
CMS staff will make sure that all of the necessary information is provided on the form, and will ensure the complete connectivity to the 270/271 application. A CMS contractor known as the Medicare Eligibility Integration Contractor (MEIC) will contact the submitter in order to authenticate the accessing entity's identity.
Once authentication has been completed, the MEIC will provide the Clearinghouses, Providers, and Trading Partners with a submitter identification (ID) that must be used on all 270/271 transactions.
The MDCN extranet application is suitable for many providers that can create, send, and receive complete X12 eligibility transactions. CMS will soon offer a second solution for providers that desire to conduct the transaction using the Direct Data Entry (DDE) version. The DDE version will allow all approved providers to conduct eligibility transactions over the public internet at no cost to the provider.
Please note that in order to access the MDCN, an entity must obtain the necessary telecommunication software from the AT&T reseller on its own.
AT&T Resellers and contact numbers include the following:
- IVANS: http://www.ivans.com; Telephone: 1.800.548.2675
- McKesson: http://www.mckesson.com; Telephone: 1.800.782.7426; Key option 5, then key option 8
MEIC Helpdesk Support
You may also contact the MEIC help desk for connectivity issues on Monday through Friday, 7:00 a.m. - 9:00 p.m. EST; Telephone: 1.866.324.7315; E-mail address: MCARE@cms.hhs.gov.
Related Links
The official instruction issued to your fiscal intermediary (FI), regional home health intermediary (RHHI), carrier, or durable medical equipment regional carrier (DMERC) regarding this change may be found by going to http://www.cms.hhs.gov/Transmittals/downloads/R700CP.pdf on the CMS Web site.
Please refer to your local FI, RHHI, Carrier or DMERC for more information about this issue. To find the toll-free phone number, go to http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site.
2005 Revised American National Standards Institute X12N 837 Professional Health Care Claim Companion Document
Provider Types Affected
Physicians and suppliers who submit electronic X12N 837 claim forms to Medicare carriers, including durable medical equipment regional carriers (DMERCs).
Background
The Centers for Medicare & Medicaid Services (CMS) is updating the current inbound 837 Professional companion document to provide revisions, correct errors, and implement additional language to cover the new National Provider Identifier (NPI).
This companion document, which is attached to CR4260, supplements (but does not contradict) the X12N 837 Professional Implementation Guide and clarifies Medicare carrier and DMERC expectations regarding data/claim submission, processing, and adjudication. The revised companion guide will be available through your Medicare carrier and DMERC via their newsletter, Web site, and and/or list serve postings.
Key Points
The most important changes to the X12N 837 Professional Health Care Claim Companion Document clarify the specific processing or adjudication of the X12 837, and include the following:
Additions
- New NPI information statement - "The National Provider Identifier (NPI) must be submitted in the NM109 segment (NM108 = XX)";
- Revised taxonomy code set statement for an updated Washington Publishing Company URL, which is http://www.wpc-edi.com/codes/taxonomy;
- New "Application Receiver Code" title to GS03 statement; Corrections/Clarifications
- Corrected qualifier statement to show that only valid qualifiers may be submitted and qualifiers submitted for Medicare processing that are not defined for use by Medicare could result in claim/ transaction rejection;
- Correction of the SV104 anesthesia value statement - changing "units" to "minutes" and correcting the Implementation Guide page reference from "400" to "403";
- Clarification of the SV104 and PS102 language to show that negative values submitted in these fields could result in claim rejection.
Additional Information
Please note the following message, which will be included in the revised X12N 837 companion document:
"The Health Insurance Portability and Accountability Act (HIPAA) requires that Medicare, and all other health insurance payers in the United States, comply with the EDI standards for health care as established by the Secretary of Health and Human Services. The X12N 837 implementation guides have been established as the standards of compliance for submission of claims for all services, supplies, equipment, and health care other than retail pharmacy prescription drug claims. The implementation guides for each X12 transaction adopted as a HIPAA standard are available electronically at http://www.wpc-edi.com. This companion document supplements, but does not contradict any requirements in the X12N 837 Professional Implementation Guide."
Relevant Links
CR4260 is the official instruction issued to your carrier, including your DMERC, regarding this change.
CR4260 may be found by going to http://www.cms.hhs.gov/Transmittals/downloads/R871CP.pdf on the CMS Web site.
Please contact your local carrier or DMERC if you have questions about this issue. To find the toll-free phone number, go to http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site.
Abatacept (Orencia)
On 12/23/2005 the FDA-approved Abatacept (Orencia) for use in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs. The approved labeled indications are ICD-9 codes 714.0, 714.1, 714.2, and 714.81. When submitting claims, use HCPCS code J3590 Unclassified Biologics and include the name of the drug, the dosage, and the NDC# in the electronic notepad for EMC claims or box 19 of the CMS 1500 form if you are still allowed to submit paper claims. At this time, the allowable will be based on 250 mg SDV @ $534.375.
Additional Requirements for the Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals - MMA
Note: This article was revised on February 21, 2006, to reflect a new CR Transmittal number, CR Web address, and CR release date. The changes were made to reflect revisions made by CMS to CR4309. All other information in the article remains the same.
Provider Types Affected
Physicians and suppliers billing Medicare carriers for Part B drugs and biologicals not paid on a cost or prospective payment system basis
Provider Action Needed
STOP - Impact to You
This article is based on Change Request (CR) 4309, which provides additional requirements for the CAP for Part B drugs and biologicals.
CAUTION - What You Need to Know
CR4309 provides additional instructions for the implementation of the CAP program. It builds on CR4064 through business requirements that were identified through the implementation process of CR4064 and the development of the final CAP rule recently published on November 21, 2005.
GO - What You Need to Do
See the Background section of this article for further details regarding these additional requirements.
Background
Change Request (CR) 4309 provides new requirements that were identified both during the coding process of CR4064 (http://new.cms.hhs.gov/transmittals/downloads/R777CP.pdf) and the publication of the final rule for the CAP for Medicare Part B drugs. It provides additional instructions for the implementation of the CAP program as outlined in CR4064, and it is tied to the business requirements in CR4064. CR4309 is not a stand-alone CR and needs to be understood in conjunction with CR4064.
The Competitive Acquisition Program (CAP) for Drugs and Biologicals Not Paid on a Cost or Prospective Payment Basis
The Medicare Prescription Improvement and Modernization Act of 2003 (MMA, Section 303 (d)), requires the implementation of a CAP for Medicare Part B drugs and biologicals not paid on a cost or prospective payment system (PPS) basis. Beginning with drugs administered on or after July 1, 2006, physicians will be given a choice between buying and billing these drugs under the average sales price (ASP) system, or obtaining these drugs from vendors selected in a competitive bidding process.
For purposes of the CAP, the term "a physician" includes individuals defined under the Social Security Act, §1861(s) who are authorized to provide physician services under §1861(s) of the Social Security Act and who can, within their State's scope of practice, prescribe and order drugs covered under Medicare Part B.
Note: For 2006, the first CAP year will run from July 1, 2006, through December 31, 2006. In subsequent years, it will run annually on a calendar year basis. MMA, Section 303 (d) may be found at http://www.cms.hhs.gov/MMAUpdate/ on the CMS Web site. Social Security Act, Section 1861(s) is available at http://www.ssa.gov/OP_Home/ssact/title18/1861.htm.
The Centers for Medicare & Medicaid Services (CMS) may exclude drugs from the CAP if competitive pricing will not result in significant savings, or is likely to have an adverse impact on access to such drugs. The statute gives CMS the authority to select drugs, or categories of drugs, that will be included in the program, to establish geographic competitive acquisition areas, and to phase in these elements as appropriate.
Award Competition
A competition will be held every three years to award contracts to approved CAP vendors that will supply drugs and biologicals for the program. A three-year contract will be awarded to qualified approved CAP vendors in each geographic area who have and maintain:
- Sufficient means to acquire and deliver competitively biddable drugs within the specified contract area;
- Arrangements in effect for shipping at least five days each week for the competitively biddable drugs under the contract and means to ship drugs in emergency situations;
- Quality, service, financial performance, and solvency standards; and
- A grievance and appeals process for dispute resolution.
A vendor's contract may be terminated during the contract period if they do not abide by the terms of their contract with CMS. CMS will establish a single payment amount for each of the competitively bid drugs and areas; for this three year cycle there will be one drug category and one geographic area. After CAP drug prices are determined and vendor contracts are awarded, the information will be posted to a directory on the Medicare Web site.
Participation in the CAP
Medicare physicians will be given an opportunity to elect to participate in the CAP on an annual basis. Physicians who elect to participate in CAP will continue to bill their local carrier for drug administration. The participating CAP physicians will receive all of their drugs from the approved CAP vendor for the drug categories they have selected, with only one exception.
The exception will be for "furnish as written" situations where:
- The participating CAP physician requires that, due to medical necessity, the beneficiary must have a specific drug, defined by its National Drug Code (NDC), for one of the Healthcare Common Procedure Coding Systems (HCPCs) code within the approved CAP vendor's drug list; and
- That specific drug NDC is not available on the drug list.
In cases where the drug is not available from the approved CAP vendor, the participating CAP physician may buy the drug, administer it to the beneficiary, and bill Medicare using the ASP system using the CAP J3-"furnish as written" modifier.
The local carrier will monitor drugs obtained using the "furnish as written" provision to ensure that the participating CAP physician is complying with Medicare payment rules.
Note: Physicians will still be able to continue to purchase and bill Medicare under the Average Sales Price (ASP) system those drugs that are covered under Medicare Part B but whose HCPCS codes are not provided by the chosen approved CAP vendor.
Providing a Drug from Physician's Stock
Under emergency situations, the CAP will allow a participating CAP physician to provide a drug to a Medicare beneficiary from his or her own stock and obtain the replacement drug from the approved CAP vendor when certain conditions are met. The local carrier will monitor drugs ordered under the emergency replacement provision to ensure that the participating CAP physician is complying with Medicare payment rules.
Approved CAP Vendor Requirements
- Approved CAP vendors must qualify for enrollment in Medicare, and will be enrolled as a new provider specialty.
- The approved CAP vendor's claims for the drugs will be submitted to one designated Medicare carrier.
- The approved CAP vendor will bill the Medicare- designated carrier for the drug and the beneficiary for any applicable coinsurance and deductible.
- Payment to the approved CAP vendor for the drug is conditioned on verification that the drug was administered to the Medicare beneficiary:
- Proof of administration must be established by matching the participating CAP physician's claim for drug administration with the approved CAP vendor's claim for the drug in the Medicare claims processing system by means of a prescription order number on both claims.
- When they are matched in the claims processing system, the approved CAP vendor will be paid in full.
- Until drug administration is verified, the approved CAP vendor may not bill the beneficiary and/or his third party insurance for any applicable coinsurance and deductible.
Physician Election and Information Transfer between Carriers and the Designated Carrier for CAP Claims
For this first CAP year, by April 3, 2006, CMS will post on its Web site:
- A list of the vendors that have been selected to participate in CAP for 2006,
- The categories of drugs they will be providing, and
- The geographic areas within which each vendor will operate.
Physicians can then elect the vendors and the categories of drugs they choose to receive drugs from under the CAP program.
For this first CAP cycle, there will be one category of drugs and one geographic area.
Note: The election process for 2006 will end May 18, 2006. In subsequent years the CAP election will take place in the fall of each year and CMS will post on its Web site the updated list of vendor information. The election process will end each year approximately 45 days after the list of vendors is posted on the CMS Web site.
Additional Requirements Regarding the CAP
Additional instructions and more complete details about the CAP requirements for Part B Drugs can be found in Change Request (CR) 4309 and its attachments. Some of these important requirements to remember are as follows:
- The CAP is only available to physicians billing Medicare on a fee-for-service basis;
- Vendors can only submit claims for drugs provided by physicians who selected that vendor;
- Members of a group must elect to participate in the CAP as a whole group when billing as a group;
- Only members of a group who have prescriptive authority are eligible to participate in the CAP;
- The J1 modifier must be on every physician claim for a CAP drug; and
- All HCPCS codes for the administration of CAP drugs must be billed as assigned.
Implementation
The implementation date for this instruction is July 3, 2006, except where otherwise indicated in this article.
Additional Information
For complete details, please see the official instruction issued to your carrier regarding this change. That instruction may be viewed at
http://www.cms.hhs.gov/Transmittals/downloads/R866CP.pdf on the CMS Web site.
In addition, you may wish to review CR4064 at http://www.cms.hhs.gov/Transmittals/downloads/R777CP.pdf and its related article at http://www.cms.hhs.gov/MedlearnMattersArticles/downloads/MM4064.pdf on the CMS Web site.
If you have any questions, please contact your carrier at their toll-free number, which may be found at http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site.
Announcement of Redesigned National Provider Identifier Web Page
Announcing the redesigned CMS Web page dedicated to providing all the latest NPI news for health care providers! Visit http://www.cms.hhs.gov/NationalProvIdentStand/ on the Web. This page also contains a section for Medicare Fee-For-Service (FFS) providers with helpful information on the Medicare NPI implementation. A new fact sheet with answers to questions that health care providers may have regarding the NPI is now available on the Web page; bookmark this page as new information and resources will continue to be posted.
For more information on private industry NPI outreach, visit the Workgroup for Electronic Data Interchange (WEDI) NPI Outreach Initiative Web site at http://www.wedi.org/npioi/index.shtml on the Web.
Appropriate Billing of Ambulance Services
Based upon recent medical record reviews of ambulance services, it was discovered that a number of ambulance services were billed according to the vehicle used instead of the service furnished to the patient. The level of service billed to Medicare must be based upon the medically necessary services actually furnished and not the capabilities of the dispatched vehicle and/or emergency personnel. For example, the vehicle and crew dispatched were capable of rendering Advanced Life Support (ALS) Services, but the medical records revealed that Basic Life Support (BLS) services were actually provided. In this instance, the transport would be billed and reimbursed as a BLS service.
Medicare only covers ambulance transports that are medically necessary and reasonable. It is the responsibility of the ambulance supplier to maintain and furnish complete and accurate documentation. The documentation must include symptoms or conditions that indicate the patient's physical condition was such that transportation by some other means would have endangered the patient's health.
Please note, the presence or absence of a signed Certificate of Medical Necessity does not automatically prove or disprove medical necessity for a non-emergency ambulance transport.
Additional information regarding ambulance services can be found in CIGNA Government Services' 2005 Ambulance Manual, Chapter 10 of the Medicare Benefit Policy Manual, and 42 CFR 410.40. These citations can be located at the following Web sites:
http://www.cignagovernmentservices.com/partb/specman/pdf/Ambulance.pdf
http://www.cms.hhs.gov/manuals/102_policy/bp102index.asp
42 CFR 410.40 found at http://www.gpoaccess.gov/cfr/index.html
April 2006 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing File and Revisions to January 2005, April 2005, July 2005, October 2005, and January 2006 Quarter ASP Medicare Part B Drug Pricing Files
Provider Types Affected
All Medicare providers who bill Medicare for Part B drugs
Provider Action Needed
STOP - Impact to You
CR4319 provides notice of the updated payment allowance limits for Medicare Part B drugs, effective April 1, 2006 through June 30, 2006, as well as revised payment files for the January 2005, April 2005, July 2005, October 2005, and January 2006 Quarter ASP Medicare Part B Drug Pricing Files.
CAUTION - What You Need to Know
Be aware that certain Medicare Part B drug payment limits have been revised and that the Centers for Medicare & Medicaid Services (CMS) updates the payment allowance quarterly. The revised payment limits included in the revised ASP and Not Otherwise Classified (NOC) payment files supersede the payment limits for these codes in any publication published prior to CR4319.
GO - What You Need to Do
Make certain that your billing staffs are aware of these changes.
Background
According to Section 303 (c) of the Medicare Modernization Act of 2003 (MMA), CMS will update the payment allowances for Medicare Part B drugs on a quarterly basis.
Beginning January 1, 2005, Part B drugs that are not paid on a cost or prospective payment basis) are paid based on 106 percent of the average sales price (ASP). Additionally, in 2006, all ESRD drugs furnished by both independent and hospital based ESRD facilities, as well as specified covered outpatient drugs, and drugs and biologicals with pass-through status under the OPPS, will be paid based on the ASP methodology. The ASP methodology is based on quarterly data submitted to CMS by manufacturers. CMS will supply Medicare contractors with the ASP drug pricing files for Medicare Part B drugs on a quarterly basis.
Beginning January 1, 2005, the payment allowance limits for Medicare Part B drugs and biologicals that are not paid on a cost or prospective payment basis are 106 percent of the ASP.
Beginning January 1, 2006, the payment allowance limits for all ESRD drugs when separately billed by freestanding and hospital-based ESRD facilities, as well as specified covered outpatient drugs, and drugs and biologicals with pass-through status under the OPPS, will be paid based on 106 percent of the ASP. CMS will update the payment allowance limits quarterly.
Exceptions to General Rule
There are exceptions to this general rule as summarized below:
Blood and Blood Products
For blood and blood products (with certain exceptions such as blood clotting factors), payment allowance limits are determined in the same manner they were determined on October 1, 2003.
The payment allowance limits for blood and blood products are 95 percent of the Average Wholesale Price (AWP) as reflected in the published compendia. The payment allowance limits will be updated on a quarterly basis.
Infusion Drugs
For infusion drugs furnished through a covered item of Durable Medical Equipment (DME) on or after January 1, 2005, payment allowance limits will continue to be 95 percent of the AWP reflected in the published compendia as of October 1, 2003, regardless of whether or not the DME is implanted.
The payment allowance limits were not updated in 2005. For infusion drugs furnished through a covered item of durable medical equipment that were not listed in the published compendia as of October 1, 2003 (i.e., new drugs), the payment allowance limits are 95 percent of the first published AWP.
Influenza, Pneumococcal, Hepatitis B Vaccines
For influenza, pneumococcal, and hepatitis B vaccines, payment allowance limits are 95 percent of the AWP as reflected in the published compendia.
Drugs Not Included in ASP Medicare Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing File For drugs (other than new drugs) not included in the ASP Medicare Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing File, payment allowance limits are based on the published Wholesale Acquisition Cost (WAC) or invoice pricing.
In determining the WAC-based payment limit, Medicare contractors (carriers, including durable medical equipment regional carriers (DMERCs), and fiscal intermediaries, including regional home health intermediaries (RHHIs)) will follow the methodology specified in the Medicare Claims Processing Manual for calculating the AWP, but substitute WAC for AWP. (See Publication 100-04, Chapter 17, Drugs and Biologicals) at http://www.cms.hhs.gov/manuals/downloads/clm104c17.pdf on the CMS Web site. The payment limit is 100 percent of the lesser of the lowest brand or median generic WAC.
Your Medicare contractor may, at their discretion, contact CMS to obtain payment limits for drugs not included in the quarterly ASP or NOC files. If available, CMS will provide the payment limits either directly to the requesting contractor or will post them in an MS Excel file on the CMS Web site. If the payment limit is available from CMS, contractors will substitute the CMS-provided payment limits for pricing based on WAC or invoice pricing.
Radiopharmaceuticals
The payment allowance limits for radio-pharmaceuticals are not subject to ASP. Your carrier/FI will determine payment limits for radiopharmaceuticals based on the methodology in place as of November, 2003.
New Drugs Produced or Distributed under a New Drug Application Approved by the Food and Drug Administration
The payment allowance limits for new drugs and biologicals not included in the ASP Medicare Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing File are based on 106 percent of the WAC. This policy applies only to new drugs that were first sold on or after January 1, 2005.
How the ASP is Calculated
The ASP is calculated using data submitted to CMS by manufacturers on a quarterly basis and each quarter, CMS will update your carrier payment allowance limits with the ASP files. On or after March 20, 2006, revised January 2005, April 2005, July 2005, October 2005, and January 2006 ASP and NOC payment files and the April 2006 ASP and NOC files will be available for download.
- The revised January 2005 payment allowance limits apply to dates of service January 1, 2005 through March 31, 2005.
- The revised April 2005 payment allowance limits apply to dates of service April 1, 2005 through June 30, 2005.
- The revised July 2005 payment allowance limits apply to dates of service July 1, 2005 through September 30, 2005.
- The revised October 2005 payment allowance limits apply to dates of service October 1, 2005 through December 31, 2005.
- The revised January 2006 payment allowance limits apply to dates of service January 1, 2006 through March 31, 2006.
- The April 2006 payment allowance limits apply to dates of service April 1, 2006 through June 30, 2006.
Note: The absence or presence of a HCPCS code and its associated payment limit does not indicate Medicare coverage of the drug or biological. Similarly, the inclusion of a payment limit within a specific column does not indicate Medicare coverage of the drug in that specific category.
The carrier processing your claim will make these determinations. For any drug or biological not listed in the ASP or NOC drug pricing files, your Medicare contractor will determine the payment allowance limits in accordance with the policies described in CR4319 and fiscal intermediaries will seek payment allowances from the local Medicare carrier.
Implementation
The implementation date for the instruction is April 3, 2006
Additional Information
The official instructions issued to your carrier/FI/RHHI/DMERC regarding this change can be found at
http://www.cms.hhs.gov/Transmittals/downloads/R876CP.pdf on the CMS Web site.
If you have questions, please contact your Medicare carrier/FI/RHHI/DMERC at their toll-free number which may be found at: http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site. More information is available at http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/ on the CMS Web site.
Bevacizumab (Avastin) in the Treatment of Neovascular (Wet) Macular Degeneration
An article regarding Bevacizumab (Avastin) in the Treatment of Neovascular (Wet) Macular Degeneration has been published for all Part B states. To view the article for your particular state, please refer to the CIGNA Government Services Web site using the following links:
• Idaho -
http://www.cignagovernmentservices.com/medicare_dynamic/clickwrap/clickwrap.asp?url=idpolicies
• North Carolina -
http://www.cignagovernmentservices.com/medicare_dynamic/clickwrap/clickwrap.asp?url=ncpolicies
• Tennessee -
http://www.cignagovernmentservices.com/medicare_dynamic/clickwrap/clickwrap.asp?url=tnpolicies
Billing Requirements for Positron Emission Tomography (PET) Scans for Dementia and Neurodegenerative Diseases
IMPORTANT NOTE: This article has been revised to include Web addresses consistent with the new CMS site. Previously, this article was revised on April 22, 2005, to show that Change Request (CR) 3426 was revised by CR3640 (Transmittal 428, dated January 14, 2005). CR3640 revised billing requirements in CR3426 for PET Scans for Alzheimer's Disease (AD) by 1) removing the edit for one scan per beneficiary's lifetime for PET AD Scans, and 2) adding requirements for specifying ICD-9 diagnosis coding. In addition, Section 60.1 of the Medicare Claims Processing Manual (Publication 100-04) was updated to include specific payment information for claims for all PET Scans for services submitted by Critical Access Hospitals (CAHs). To see CR3640, go to http://www.cms.hhs.gov/Transmittals/downloads/R428CP.pdf on the CMS Web site. Also, the Medlearn Matters article related to CR3640 is located at http://www.cms.hhs.gov/MedlearnMattersArticles/downloads/MM3640.pdf on the CMS Web site.
Provider Types Affected
Physicians and providers
Provider Action Needed
This instruction notifies physicians and providers that Medicare will provide coverage for 2-deoxy-2- [F-18] fluoro-D-glucose (FDG)-PET scans for beneficiaries with a recent diagnosis of dementia and documented cognitive decline of at least 6 months duration. This service may be covered:
- When the patient meets diagnostic criteria for both fronto-temporal dementia (FTD) and Alzheimer's disease (AD) under specific requirements; or
- For use in a Centers for Medicare & Medicaid Services (CMS)-approved practical clinical trial focused on the utility of FDG-PET in the diagnosis or treatment of dementing neurodegenerative diseases.
Background
Effective for dates of service on or after September 15, 2004, Medicare will provide coverage for FDG Positron Emission Tomography PET for one of the following:
- When the patient meets diagnostic criteria for both fronto-temporal dementia (FTD) and Alzheimer's disease; or
- When used in a CMS-approved practical neurodegenerative disease clinical trial.
Clinical trial results are expected to help in determining if PET scans contribute to the effective diagnosis and treatment of Medicare beneficiaries with mild cognitive impairment or early dementia, and add information that will help monitor, evaluate, and improve clinical outcomes of patients with this disease.
Refer to the Medicare Claims Processing Manual, Publication 100-04, Chapter 13, Section 60, for general Medicare coverage and billing requirements for PET scans for dementia and neurodegenerative diseases.
Also, refer to the Medicare National Coverage Determinations (NCD) Manual, Publication 100-03, Section 220.6 for complete coverage policy and clinical trial requirements. The revision to the NCD Manual, Section 220.6 is an NCD. NCDs are binding on all carriers, fiscal intermediaries, quality improvement organizations, health maintenance organizations, competitive medical plans, and health care prepayment plans.
Under 42 Code of Federal Regulations (CFR) 422.256(b), an NCD that expands coverage is also binding on Medicare Advantage Organizations. In addition, an administrative law judge may not review an NCD. (See §1869(f)(1)(A)(i) of the Social Security Act.)
Key portions of these revised manuals are as follows:
FDG-PET Requirements for Use in the Differential Diagnosis of AD and FTD
According to the NCD on this issue, Medicare covers FDG-PET scans for either a) the differential diagnosis of both FTD and Alzheimer's disease AD under specific requirements or, b) its use in a CMS-approved practical clinical trial focused on the utility of FDG-PET in the diagnosis or treatment of dementing neurodegenerative diseases.
For use in the differential diagnosis of FTD and AD, an FDG-PET scan is considered reasonable and necessary for patients with a recent diagnosis of dementia and documented cognitive decline of at least 6 months, who meet diagnostic criteria for both AD and FTD. These patients have been evaluated for specific alternative neurodegenerative diseases or causative factors, but the cause of the clinical symptoms remains uncertain.
The following additional conditions must be met before an FDG-PET scan can be ordered:
- The patient's onset, clinical presentation, or course of cognitive impairment is such that FTD is
suspected as an alternative neurodegenerative cause of the cognitive decline. Specifically,
symptoms such as social disinhibition, awkwardness, difficulties with language, or loss of executive function are more prominent early in the course of FTD than the memory loss typical of AD; - The patient has had a comprehensive clinical evaluation (as defined by the American Academy of Neurology (AAN)) encompassing a medical history from the patient and a well-acquainted informant (including assessment of activities of daily living), physical and mental status examination (including formal documentation of cognitive decline occurring over at least 6 months) aided by cognitive scales or neuropsychological testing, laboratory tests, and structural imaging such as magnetic resonance imaging (MRI) or computed tomography (CT);
- The evaluation of the patient has been conducted by a physician experienced in the diagnosis and assessment of dementia;
- The evaluation of the patient did not clearly
determine a specific neurodegenerative disease
or other cause for the clinical symptoms, and information available through FDG-PET is reasonably expected to help clarify the diagnosis between FTD and AD and help guide future treatment; - The FDG-PET scan is performed in a facility that has all the accreditation necessary to operate nuclear medicine equipment. The reading of the scan should be done by an expert in nuclear medicine, radiology, neurology, or psychiatry, with experience interpreting such scans in the presence of dementia;
- A brain single photon emission computed tomography (SPECT) or FDG-PET scan has not been obtained for the same indication. The indication can be considered to be different in patients who exhibit important changes in scope or severity of cognitive decline, and meet all other qualifying criteria listed above and below (including the judgment that the likely diagnosis remains uncertain).
The results of a prior SPECT or FDG-PET scan must have been inconclusive or, in the case of SPECT, difficult to interpret due to immature or inadequate technology. In these instances, an FDG-PET scan may be covered after 1 year has passed from the time the first SPECT or FDG-PET scan was performed.
- The referring and billing provider(s) have documented the appropriate evaluation of the Medicare beneficiary. Providers should establish the medical necessity of an FDG-PET scan by ensuring that the following information has been collected and is maintained in the beneficiary medical record:Date of onset of symptoms;
- Diagnosis of clinical syndrome (normal aging; mild cognitive impairment or MCI; mild, moderate
or severe dementia); - Mini mental status exam (MMSE) or similar test score;
- Presumptive cause (possible, probable, uncertain AD);
- Any neuropsychological testing performed;
- Results of any structural imaging (MRI or CT) performed;
- Relevant laboratory tests (B12, thyroid hormone); and
- Number and name of prescribed medications.
- The billing provider must furnish a copy of the FDG-PET scan result for use by CMS and its contractors upon request.
- These services should be billed with HCPCS code of G0336 (Pet imaging, brain imaging for the differential diagnosis of Alzheimer's disease with aberrant features vs. FTD).
FDG-PET Requirements for Use in the Context of a CMS Approved Neurodegenerative Disease Practical Clinical Trial Utilizing Specific Protocol
With regard to use of the FDG-PET in the context of a CMS-approved clinical trial, the clinical trial must compare patients who do and those who do not receive an FDG-PET scan and have as its goal to monitor, evaluate, and improve clinical outcomes. In addition, it must meet the following basic criteria:
- Written protocol on file;
- Institutional Review Board review and approval;
- Scientific review and approval by two or more qualified individuals who are not part of the research team; and
- Certification that investigators have not been disqualified.
Physicians should note that a QV modifier must be used when billing Medicare carriers for a CMS-approved neurodegenerative disease practical clinical trial. In addition, on such claims from trials that are billed to Medicare intermediaries, a second diagnosis code (ICD-9) of V70.7, along with the appropriate principal diagnosis code and HCPCS code G0336 must be entered on the CMS-1450 or its electronic equivalent. There will be a link on the cms.hhs.gov/coverage Web site that will have a list of all the participating trial facilities once they have been selected.
Implementation
The implementation date for this instruction is October 4, 2004.
Additional Information
As previously mentioned, the Medicare Claims Processing Manual (Publication 100-04), Chapter 13 (Radiology Services), Section 60 (Positron Emission Tomography (PET) Scans), is being updated by this instruction. It includes billing and claims processing requirements for PET Scans for beneficiaries with a recent diagnosis of dementia and documented cognitive decline of at least six months duration who meet diagnostic criteria for both FTD and AD, or its use in a CMS approved practical clinical trial focused on the utility of FDG-PET in the diagnosis or treatment of dementing neurodegenerative diseases.
In addition, the Medicare NCD Manual (Publications 100-03), Chapter 1 (Coverage Determinations) Section 220 (Radiology), Subsection 6 (Positron Emission Tomography (PET)) Scans, is being updated by this instruction to include complete coverage policy and requirements for related clinical trials.
These updated manual instructions are included in the official instruction issued to your carrier/intermediary, which can be found by going to http://www.cms.hhs.gov/Transmittals/downloads/R310CP.pdf on the CMS Web site.
If you have questions, please contact your intermediary at their toll-free number, which may be found at http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site.
Botulinum Toxin - Revision
The LCD for Botulinum Toxin has been revised for all Part B states. CPT codes 95873 and 95874 were added for medical necessity. To view the article for your particular state, please refer to the CIGNA Government Services Web site using the following links:
• Idaho -
http://www.cignagovernmentservices.com/medicare_dynamic/clickwrap/clickwrap.asp?url=idpolicies
• North Carolina -
http://www.cignagovernmentservices.com/medicare_dynamic/clickwrap/clickwrap.asp?url=ncpolicies
• Tennessee -
http://www.cignagovernmentservices.com/medicare_dynamic/clickwrap/clickwrap.asp?url=tnpolicies
Change in the Long Descriptor for HCPCS Code Q4080
Provider Types Affected
Physicians, suppliers, and providers billing Medicare carriers, including durable medical equipment regional carriers (DMERCs) and/or fiscal intermediaries (FIs), including regional home health intermediaries (RHHIs), for services related to ILOPROST inhalation treatment of Medicare beneficiaries.
Provider Action Needed
This article is based on Change Request (CR) 4324, which provides information on the revised code dosage descriptor for Q4080. This is a non-systems change CR.
Background
The Centers for Medicare & Medicaid Services (CMS) established Healthcare Common Procedure Coding System (HCPCS) code Q4080 that was effective July 1, 2005, with a code descriptor that read:
"ILOPROST, INHALATION SOLUTION, ADMINISTERED THROUGH DME, 20 MICROGRAMS."
Effective January 1, 2006, the long code descriptor for HCPCS code Q4080 will read:
"ILOPROST, INHALATION SOLUTION, ADMINISTERED THROUGH DME, UP TO 20 MCG."
The short descriptor for HCPCS code Q4080 will continue to read:
"Iloprost inhalation solution."
CR4324 provides clarification on the change in the long descriptor for HCPCS code Q4080 effective January 1, 2006.
Implementation
The implementation date for the instruction is March 13, 2006.
Additional Information
For complete details, please see the official instruction issued to your carrier/DMERC/intermediary/RHHI regarding this change. That instruction may be viewed at http://www.cms.hhs.gov/Transmittals/downloads/R209OTN.pdf on the CMS Web site.
If you have any questions, please contact your carrier/DMERC/intermediary/RHHI at their toll-free number, which may be found at http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site.
Change Payment Floor Date for Paper Claims
Provider Types Affected
Physicians, providers, and suppliers who use paper claims to bill Medicare carriers, including durable medical equipment regional carriers (DMERCs), and fiscal intermediaries (FIs), including regional home health intermediaries (RHHIs)
Important Points to Remember
- CR4284 changes the payment floor date for paper claims from the 27th day to the 29th date after receipt of a claim.
- Effective January 1, 2006, Medicare carriers, DMERCs, FIs, and RHHIs will not pay paper claims prior to the 29th day after receipt of the claim.
Background
The Social Security Act Section 1816b (c) (3) (B) (ii) and Section 1842 (c) (3) (B) (ii) provides for payment waiting periods for Medicare claims before a claim is paid by the Medicare contractor. Congress has amended the Social Security Act to extend the waiting period for paper claims from 27 to 29 days, effective January 1, 2006.
Implementation
The implementation date for this instruction is March 13, 2006.
Additional Information
The official instructions issued to your carrier regarding this change can be found at http://www.cms.hhs.gov/Transmittals/downloads/R850CP.pdf on the CMS Web site.
If you have questions, please contact your Medicare carrier, DMERC, FI, or RHHI at their toll-free number which may be found at http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site.
Clinical Pathology Consultations
Limited Consultation (CPT 80500) and Comprehensive Consultation (CPT 80502)
A clinical pathology consultation is a service, including a written report, rendered by the pathologist in response to a request from an attending physician in relation to a test result(s) requiring additional medical interpretive judgment. A medical review including CPT codes 80500 and 80502 indicated that there was a lack of documentation to support payment of these services. In many cases, the physician's order for a pathology consultation was not present. Laboratory providers billed Medicare for these additional services referring to them as "Pathologist Interpretations."
Medicare reimburses clinical consultation services under the physician fee schedule only after satisfying all of the following requirements:
- Services are requested by the patient's attending physician
- Services relate to a test result that lies outside of the clinically significant normal or expected range
- Services result in written narrative report
- Services require the medical judgment of the consulting physician.
Standing orders do not meet the criteria because the results are not known at the time of the request and may not lie significantly outside of the normal range.
Medicare Part B Medical Policy: Clinical Pathology Consultation, Pages 18-20, March 2003.
Collection and Verification of Ambulance Crew Member Information
Provider Types Affected
Providers and suppliers who bill Medicare carriers for ambulance services
Key Points
- Effective February 9, 2006, the Centers for Medicare & Medicaid Services (CMS) will no longer require enrolled ambulance suppliers to report crew member changes in Attachment 1 of the provider enrollment application CMS-855B.
- This policy change only applies to ambulance companies already enrolled with Medicare.
- Ambulance suppliers that are enrolling in the Medicare program for the first time or are submitting a new enrollment application are required to report ambulance crew member information in Attachment 1 of the provider enrollment application (CMS-855B).
- This change should reduce the paperwork burden imposed on ambulance suppliers and reduce the number of ambulance supplier changes processed by contractors.
Background
On January 27, 2006, CMS published a Federal Register notice requesting public comments on revisions to the provider enrollment applications. While CMS is seeking comments regarding proposed changes to its Medicare enrollment applications, it is also adopting a policy change that affects ambulance suppliers effective immediately with regard to reporting crew member information as noted above.
Relevant Links
The Medicare Federal Health Care Provider/Supplier Enrollment Application Form CMS-855B can be found at http://new.cms.hhs.gov/MedicareProviderSupEnroll/downloads/cms855b.pdf on the CMS Web site.
If you have any questions regarding this issue, contact your carrier at their toll-free number, which is available at http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site.
Colorectal Cancer: Preventable, Treatable, and Beatable: Medicare Coverage and Billing for Colorectal Cancer Screening
Provider Types Affected
Physicians, nurse practitioners, physician assistants, clinical nurse specialists, outpatient hospital departments, community surgical centers
Provider Action Needed
STOP - Impact to You
March is National Colorectal Cancer Awareness Month. The Centers for Medicare & Medicaid Services (CMS) would like to remind providers to encourage their eligible Medicare patients ages 50 and older to get screened for colorectal cancer. This Medlearn Matters Special Edition issue reviews Medicare coverage and billing processes for colorectal cancer screening.
CAUTION - What You Need to Know
Medicare has covered colorectal cancer screening since 1998, but the benefit is underused. Claims data from 1998-2002 indicate that less than half of Medicare beneficiaries had any screening test during this five-year period, and less than one-third were tested according to recommended intervals.
GO - What You Need to Do
Encourage your patients to be screened, appropriately bill Medicare for the screening test you provide, and follow up with patients, as needed.
Background
Colorectal cancer is the second leading cause of cancer death in the United States and the third most common type of cancer. In 2005, colorectal cancer was expected to account for 56,290 deaths and 145,290 new cases. Colorectal cancer primarily affects men and women ages 50 and older, and risk increases with age. If detected early, colorectal cancer can be treated and cured.
In January 1998, Medicare began covering colorectal cancer screening. The data currently available (1998-2002) indicates that the colorectal cancer screening benefit is underused. Less than half of enrollees had any colorectal cancer test during the five-year period and less than one-third were tested according to commended intervals.
The U.S. Preventive Services Task Force (USPSTF) evaluates the clinical merits of preventive measures, and strongly recommends ("A" rating) that clinicians screen men and women ages 50 and older for colorectal cancer. The choice of screening strategy should be based on patient preferences, medical contraindications, patient adherence, and resources for testing and follow-up. To read the full recommendation, go to the following link: http://www.ahrq.gov/clinic/uspstf/uspscolo.htm
The Partnership for Prevention conducted a systematic assessment of the clinical preventive services recommended by the USPSTF to help decision-makers identify those services that provide the most value based on two criteria burden of disease prevented and cost-effectiveness. Screening adults for colorectal cancer screening was among the services considered to be of the greatest value.
Colorectal Cancer Screening Methods
There are a variety of methods available for colorectal cancer screening, including fecal occult blood testing, flexible sigmoidoscopy, colonoscopy, and screening barium enema. It is important that practitioners follow the practice guidelines for screening and follow-up.
Two studies published in January 2005 in the Annals of Internal Medicine suggest that the office-based single sample screening fecal occult blood test is of limited value, and that many physicians are not following practice guidelines for screening and follow-up. Click on the following link for information on colorectal cancer detection and American Cancer Society screening recommendations and guidelines:
http://www.cancer.org/docroot/CRI/content/CRI_2_6X_Colorectal_Cancer_Early_Detection_10.asp?sitearea=&level
Coverage
Medicare covers the following colorectal cancer screening tests and procedures:
Fecal Occult Blood Test (FOBT)
Medicare covers one FOBT annually for beneficiaries 50 and older. A written order from the beneficiary's attending physician is required. Medicare will pay for an immunoassay-based FOBT as an alternative to the guaiac-based FOBT, but will only pay for one FOBT, not both, per year.
Beneficiaries do not have to pay coinsurance for the FOBT, and don't have to meet the annual Medicare Part B deductible.
Screening Flexible Sigmoidoscopy
Medicare covers a screening flexible sigmoidoscopy once every four years for beneficiaries 50 and older. If a beneficiary had a screening colonoscopy in the previous 10 years, then the next screening flexible sigmoidoscopy would be covered only after 119 months have passed following the month in which the last screening colonoscopy was performed. A doctor of medicine or osteopathy, a physician assistant, a nurse practitioner, or a clinical nurse specialist may perform a screening flexible sigmoidoscopy.
Screening Colonoscopy
Medicare coverage for a screening colonoscopy is based on beneficiary risk.
- For beneficiaries 50 and older not considered to be at high risk for developing colorectal cancer, Medicare covers one screening colonoscopy every 10 years, but not within 47 months of a previous screening flexible sigmoidoscopy.
- For beneficiaries considered to be at high risk for developing colorectal cancer, Medicare covers one screening colonoscopy every two years, regardless of age.
- A screening colonoscopy must be ordered and provided by a doctor of medicine or osteopathy.
Screening Barium Enema
- Medicare covers a screening barium enema as an alternative to a screening flexible sigmoidoscopy or a screening colonoscopy.
- For beneficiaries 50 and older not considered to be at high risk for developing colorectal cancer, Medicare covers one screening barium enema every four years.
- For beneficiaries considered to be at high risk for developing colorectal cancer, Medicare covers one screening barium enema every two years regardless of age.
A screening barium enema must be ordered in writing and provided by a doctor of medicine or osteopathy once it is determined that it is the appropriate screening method for a beneficiary. A double contrast barium enema is preferable, but the physician may order a single contrast barium enema if it is more appropriate for the beneficiary.
The beneficiary is liable for paying 20% of the Medicare-approved amount (the coinsurance) for screening flexible sigmoidoscopy, screening colonoscopy, and screening barium enema after meeting the annual Medicare Part B deductible.
For a screening flexible sigmoidoscopy or a screening colonoscopy performed in a hospital outpatient department, the beneficiary is liable for paying the Medicare approved amount (the coinsurance) after meeting the annual Medicare Part B deductible.
Beneficiaries are considered to be at high risk for colorectal cancer if they have any of the following:
- A close relative (sibling, parent, or child) who has had colorectal cancer or an adenomatous polyp;
- A family history of adenomatous polyposis;
- A family history of hereditary nonpolyposis colorectal cancer;
- A personal history of adenomatous polyps;
- A personal history of colorectal cancer;
- A personal history of inflammatory bowel disease, including Crohn's Disease and ulcerative colitis.
How to Bill Medicare
The following Healthcare Common Procedure Coding System (HCPCS) codes should be used to bill for colorectal cancer screening:
| HCPCS Code |
HCPCS Code Descriptor |
| G0104 | Colon cancer screening; flexible sigmoidoscopy |
G0105* |
Colon cancer screening; colonoscopy on individual at high risk |
| G0106 | Colon cancer screening; barium enema as an alternative to G0104 |
| G0107 | Colon cancer screening; FOBT, 1-3 simultaneous determinations |
| G0120 | Colon cancer screening; barium enema as an alternative to G0105 |
| G0121 | Colon cancer screening; colonoscopy for individuals not meeting criteria for high risk |
| G0122** | Colon cancer screening; barium enema (non-covered) |
| G0328 | Colon cancer screening; as an alternative to G0107; fecal occult blood test, immunoassay, 1-3 simultaneous determinations |
* When billing for the "high risk" beneficiary, the screening diagnosis code on the claim must reflect
at least one of the high risk conditions mentioned previously. Examples of diagnostic codes are in
the colorectal cancer screening chapter (page 81) of the Guide to Preventive Services. This guide
is available at http://www.cms.hhs.gov/MedlearnProducts/downloads/PSGUID.pdf on the CMS Web site.
**Code G0122 should be used when a screening barium enema is performed not as an alternative to either to G0104 or G0105. This service is denied as non-covered because it fails to meet the requirements of the benefit. The beneficiary is liable for payment. Reporting of this non covered code will also allow claims to be billed and denied for beneficiaries who need a Medicare denial for other insurance purposes.
If billing Medicare carriers, the appropriate HCPCS and corresponding diagnosis codes must be provided on Form CMS-1500 (or the HIPAA 837 Professional electronic claim record).
If billing Medicare intermediaries, the appropriate HCPCS, revenue, and corresponding diagnosis codes must be provided on Form CMS-1450 (or the HIPAA Institutional electronic claim record). Information on the type of bill and associated revenue code is also provided in the colorectal cancer screening chapter (page 82) of the Guide to Preventive Services. This guide is available at: http://www.cms.hhs.gov/MedlearnProducts/downloads/PSGUID.pdf on the CMS Web site. Reimbursement information is also provided in this guide.
Other Helpful Information
CMS has developed a comprehensive prevention Web site that provides information and resources for all Medicare preventive benefits. The following link is to the colorectal cancer screening section, and includes Web site links to information and resources developed by other organizations interested in promoting colorectal cancer screening, including the National Cancer Institute, the Centers for Disease Control and Prevention, and the American Cancer Society: http://www.cms.hhs.gov/ColorectalCancerScreening/.
Also, visit the Medicare Learning Network (MLN) Web site at http://www.cms.hhs.gov/Medlearn/ to access the Guide to Medicare Preventive Services for Physicians, Providers, Suppliers, and Other Health Care Professionals as well as other educational resources designed for health care professionals to promote and increase national awareness of Medicare-covered preventive services. Once on the MLN site, scroll to the bottom of the page and click on Products, then click on Preventive Services.
Competitive Acquisition Program (CAP) for Part B Drugs-Coding, Testing, and Implementation - MMA
Provider Types Affected
Physicians billing Medicare carriers for Part B drugs and approved CAP vendors billing the designated carrier
Provider Action Needed
STOP - Impact to You
Beginning in April 2006, Medicare physicians will be given the opportunity to elect to participate in the Competitive Acquisition Program (CAP) for claims paid on or after July 1, 2006. Participating CAP
physicians will obtain Medicare Part B covered drugs from selected drug categories through the CAP. Until further notice, there is only one drug category in the CAP. (Note: Exact dates of the physician election period will be announced on the comp bid Web site (http://www.cms.hhs.gov/CompetitiveAcquisforBios)
and via a list serv notice).
CAUTION - What You Need to Know
Participating CAP physicians will receive all of their Part B drugs from the approved CAP vendor for the drug category (ies) they have selected.
The only exception is the "furnish as written" situation, in which the participating CAP physician requires that, because of medical necessity, the beneficiary must have a certain brand of a drug or a particular product identified by the product's National Drug Code (NDC) and that specific drug is not available for the HCPCS code listed on the approved CAP vendor's drug list. This one exception will be identified with the use of the new CAP J3 modifier.
Physicians participating in the CAP program should pay particular attention to the discussion in this article concerning the CAP J1, J2, and J3 modifiers.
GO - What You Need to Do
In April 2006, the Centers for Medicare & Medicaid Services (CMS) will post on its Web site a list of the CAP vendors and the drugs they will supply. Physicians wishing to participate in the CAP program in 2006 must elect to do so within 45 days of the date the election information is posted. The election agreement is effective on July 1, 2006. See the Background section of this article for further details regarding these changes.
Background
This article includes information from Change Request (CR) 4064, which provides instructions to Medicare carriers regarding the CAP program. This new CAP program applies to physician-injectable and infused drugs covered under Medicare's Supplemental Insurance (Part B) program that are commonly provided incident to a physician's service. This program does NOT apply to drugs included in the new Prescription Drug Benefit under Part D, which goes into effect on January 1, 2006.
Physicians (and other practitioners who provide physician services that include the authority to prescribe and order Medicare Part B drugs) wishing to participate in the CAP program in 2006 must elect to do within 45 days of the date that the election information is posted on the CMS Web site.
The election agreement is effective on July 1, 2006. Each subsequent year, the election period will be in the fall and physicians must make their participation decision within 45 days after CMS publishes the list of vendors and their drug list for the following year on the CMS Web site. Election decisions will take effect on the following January 1.
How Drugs Are Selected For CAP
The CMS may exclude drugs from the CAP if competitive pricing will not result in significant savings, or is likely to have an adverse impact on access to such drugs.
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) gives CMS the authority to:
- Select drugs (or categories of drugs) that will be included in the CAP program,
- Establish geographic competitive acquisition areas, and
- Phase in these elements as appropriate.
How Approved CAP Vendors Are Selected
A competition will be held every three years to award contracts to vendors that will supply drugs and biologicals for the program. A three year contract will be awarded to qualified approved CAP vendors in each geographic area who have and maintain:
- Sufficient means to acquire and deliver competitively biddable drugs within the specified contract area;
- Arrangements in effect for shipping at least 5 days each week for the competitively biddable drugs under the contract and means to ship drugs in emergency situations;
- Quality, service, financial performance, and solvency standards; and
- A grievance and appeals process for dispute resolution.
Approved CAP vendors must qualify for enrollment as a Medicare supplier, and they will be enrolled as a new provider specialty type.
CMS will establish a single payment amount for each of the competitively bid drugs and areas. For this three year contract cycle there will be one drug category and one geographic area for CAP. After CAP drug prices are determined and vendor contracts are awarded, the information will be posted to a directory at http://www.cms.hhs.gov/CompetitiveAcquisforBios on the CMS Web site.
Obtaining Drugs in the CAP
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA, Section 303 (d)) 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.
Beginning with Part B drugs administered on or after July 1, 2006 incident to a physician service, Medicare physicians will be given a choice between:
- Buying and billing these drugs under the Average Sales Price (ASP) system; or
- Obtaining these drugs from vendors selected in the CAP's competitive bidding process.
Physicians (and other practitioners who provide physician services that include the authority to prescribe and order Medicare Part B drugs) will be given the opportunity to participate in the CAP. Approved CAP vendors will supply the drugs and biologicals for the participants of this program.
Physicians who elect to participate in CAP will continue to bill their local carrier for drug administration.
Participating CAP physicians will receive all of their drugs from the approved CAP vendor for the drug categories they have selected, with only one exception:
The exception will be for "furnish as written" situations in which the participating CAP physician specifies that, because of medical necessity, the beneficiary must have a certain brand of a drug or a particular product defined by the product's National Drug Code (NDC) and that drug is not available for the HCPCS codes listed on the approved CAP vendor's drug list.
In those cases, the participating CAP physician may:
- Buy the drug;
- Administer it to the beneficiary; and
- Using the appropriate modifier (see below discussion of modifiers), bill Medicare using the average sales price (ASP) methodology.
In addition, under emergency situations, the CAP will allow a participating CAP physician to provide a drug to a Medicare beneficiary from his or her own stock and obtain the replacement drug from the approved CAP vendor under the emergency replacement provision when certain conditions are met as follows:
- The drug was required immediately;
- The need for the drug could not be anticipated;
- The CAP vendor could not deliver the drug in time;
- The drug was administered in an emergency situation; and
- Documentation is maintained on file to validate these conditions.
Note: Physicians will still be able to continue to purchase and bill Medicare under the Average Sales Price (ASP) system those drugs that are covered under Medicare Part B but whose HCPCS codes are not provided by the chosen approved CAP vendor.
Physician Billing
Physicians will be given the opportunity to participate in the CAP on an annual basis, and those who elect to participate in CAP will continue to bill their local carrier for the drug's administration. They will agree to submit a claim to Medicare within 14 days of the administration of the CAP drug.
The carrier will deny any physician Part B claims for drugs included in the CAP unless the CAP modifier codes are appropriately included. CAP has three modifier codes that will need to be used when physicians submit claims to their carriers for the administration of CAP drugs. The new CAP modifier codes are:
- J1 - Competitive Acquisition Program, no-pay submission for a prescription number
- J2 - Competitive Acquisition Program (CAP), restocking of emergency drugs after emergency administration and a prescription number
- J3 - Competitive Acquisition Program (CAP), drug not available through CAP as written, reimbursed under average sales price (ASP) methodology.
Participating CAP physicians will also use a prescription/order number to identify each CAP drug administered. This number will be matched to the prescription/order number(s) on the approved CAP vendor's claim as verification that the beneficiary received the drug(s) and that the approved CAP vendor may now be paid by Medicare.
When physicians submit claims for the administration of CAP drug (s) to their carriers, they should include:
- A prescription/order number for each CAP drug administered;
- The HCPCS code for each CAP drug administered along with the new "J1" nopay modifier;
- The HCPCS code(s) that include the administration of each CAP drug on separate lines.
Note: On paper claims, the prescription numbers will be in Item 19. When physicians submit claims for the administration of CAP drug(s) that have been administered in an emergency situation and required "emergency restocking" from the approved CAP vendor, the claim should be submitted with the:
- Prescription/order number for each CAP drug administered;
- HCPCS code for each administered CAP drug along with the new "J1" no-pay modifier and also on that same line, the new "J2" modifier denoting "Competitive Acquisition Program, (CAP) restocking of emergency drugs after emergency administration;" and
- HCPCS code(s) that include the administration of each CAP drug on separate lines.
When physicians submit claims for "furnish as written" drugs to be paid outside the CAP program:
- Physicians should use only the new "J3" modifier denoting "Competitive Acquisition Program (CAP), drug not available through CAP as written, reimbursed under the average sales price methodology."
Physicians who elect CAP should note:
- The administration services and the no-pay lines must be on the same claim or your carrier will return the claim as unprocessable and you will see
a remittance advice reason code of 16 denoting
claim lacks information which is needed for adjudication. - The Medicare carrier will identify them as physicians who elected to participate in CAP and who will not be paid for the drugs obtained from the approved CAP vendor.
Additionally, unless claims for CAP administration do not include the CAP drug no-pay, restocking, or "furnish as written" modifier, the claim will be denied and you will see a remittance advice, N348, stating that "You chose that this service/supply/drug be rendered/supplied and billed by a different
practitioner/supplier. "
Note: The physician's local carrier will monitor drugs that are:
- Obtained using the "furnish as written" provision to ensure that the participating CAP physician is complying with Medicare payment rules; and
- Ordered under the replacement provision to ensure that the participating CAP physician is complying with Medicare payment rules.
Vendor Billing
The approved CAP vendor will bill the:
- Medicare designated carrier for the drug; and
- Beneficiary for any applicable coinsurance and deductible.
The approved CAP vendor will also include a prescription/order number on the claim to identify each CAP drug administered.
Note: Payment to the approved CAP vendor for the drug is conditioned on verification that the drug was administered to the Medicare beneficiary. Proof that the drug was administered shall be established by matching the participating CAP physician's claim for drug administration with the approved CAP
vendor's claim for the drug in the Medicare claims processing system by means of a prescription number on both claims. When they are matched in the claims processing system, the approved CAP vendor will be paid in full.
Until drug administration is verified, the approved CAP vendor may not bill the beneficiary and/or his third party insurance for any applicable coinsurance and deductible.
Implementation
The implementation date for this instruction is July 3, 2006.
Additional Information
For complete details, please see the official instruction issued to your carrier regarding this change. That instruction may be viewed by going to http://www.cms.hhs.gov/Transmittals/downloads/R777CP.pdf on the CMS Web site.
Also, additional information on the CAP program is available at http://www.cms.hhs.gov/CompetitiveAcquisforBios/ on the CMS Web site.
If you have any questions, please contact your carrier at their toll-free number, which may be found at http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site
CPT 90862 vs M0064
The Medicare/Medicaid Data Project Team* for North Carolina identified, through a data analysis study, that billing for Current Procedural Terminology (CPT) 90862 (pharmacologic management, including prescription, use and review of medication with no more than minimal medical psychotherapy) accounts for 97% of the pharmacologic management codes being billed, while the billing for CPT code M0064 (brief office visit for the sole purpose of monitoring or changing drug prescriptions) accounts for 3% . The study spanned the timeframe of January 1, 2003, through December 31, 2004. The results of this study revealed that out of over 2,000 providers in North Carolina billing CPT code 90862, only 144 have used CPT M0064.
CPT code 90862 is not intended to refer to a brief evaluation of the patient's state or simple dosage adjustment of long-term medication. This code should be used in conjunction with in-depth management of psychopharmacologic agents, which are potent medications with frequent serious side effects and should represent a very skilled aspect of patient care. There should be a review of the medication and its side effects, or any drug-drug interactions, as well as a problem focused history and a mental status exam to assess the patient's response to treatment. A portion of this billing includes the writing or renewing of a prescription. This CPT code is similar to CPT code 99214.
CPT code M0064 should be used for a lesser level of drug monitoring, such as changing the dosage of prescriptions that are used in the treatment of mental, psychoneurotic and personality disorders. This CPT code is similar to 99212.
Medicare Bulletin-July/August 2001 All States, GR 01-4, GR 01-4, Medicare Bulletin April/May 1997 North Carolina, GR 97-2
Creation of a Second Participation Enrollment Period for 2006
Provider Types Affected
Physicians who bill Medicare carriers for their services
Key Points
- The Centers for Medicare & Medicaid Services (CMS) is offering a second participation enrollment period for 2006 for physicians.
- This second enrollment period will run for 45 days. It will begin on February 15, 2006, and end on March 31, 2006. Your Medicare carrier will accept any participation enrollment changes for 2006 that are received or post-marked by March 31, 2006.
- Any revisions to the participation election during this new enrollment period will be retroactive to January 1, 2006.
- This second enrollment period will allow you to reconsider your decisions in light of the revised 0
percent update stemming from the Deficit Reduction Act of 2005, and the related revision to
the 2006 Medicare Physician Fee Schedule (MPFS). - If you choose to submit your participation election (or withdrawal request) during this second enrollment period, you must begin to bill claims in accordance with your decision once the election is submitted to your local carrier.
- If you do not wish to change your current participation, or non-participation status, you do not need to do anything.
Additional Information
Enrollment Information
- To enroll, please use the Medicare Participating Physician or Supplier Agreement (Form CMS- 460). A copy of this form is attached to Change Request (CR) 4051, Transmittal R730CP, Calendar Year (CY) 2006 Participation Enrollment and Medicare Participating Physicians and Suppliers Directory (MEDPARD) Procedures. This CR can be found at http://www.cms.hhs.gov/Transmittals/downloads/R730CP.pdf on the CMS Web site.
- If you are unable to access the internet, please contact your Medicare carrier (toll-free telephone numbers are available through the link below) to request a hard-copy of the Medicare Participating Physician or Supplier Agreement (Form CMS- 460).
- The Medicare fee-for-service contractor that serves your state is responsible for processing your participation election (or withdrawal request). To locate the mailing address for the Medicare fee- for-service contractor for your state and provider type, please use the link to your carrier's toll-free phone number located below.
Note: To avoid processing delays, do not mail your application to the Centers for Medicare & Medicaid Services in Baltimore, Maryland.
- Your carrier will not automatically adjust any claims paid for services on or after January 1 based on any participation change made during this second period. However, the carrier will adjust such claims if you bring the claims to their attention.
CR4346 is the official instruction issued to your carrier regarding changes mentioned in this article. CR4346 may be found by going to http://www.cms.hhs.gov/Transmittals/downloads/R210OTN.pdf on the CMS Web site.
Please refer to your local carrier if you have questions about this issue. To find your carrier's toll-free phone number, go to: http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site.
Eliminate the Use of Surrogate Unique Physician Identification Numbers (UPINs) on Medicare Claims
Note: This article was revised on February 16, 2006, to remove a reference to FIs in the second bullet point on page 2.
Provider Types Affected
Physicians, suppliers, and providers billing Medicare carriers, including durable medical equipment regional carriers (DMERCs), using surrogate UPINs
Provider Action Needed
This article is based on Change Request (CR) 4177, which directs your carrier or DMERC to no longer accept the surrogate UPIN OTH000 to identify ordering or referring physicians on claims submitted by billers, suppliers, physicians, and nonphysician practitioners. (Beneficiary submitted claims and mass immunization claims are excluded.)
Background
The Social Security Act (Section 1833(q)) requires that all physicians who meet the definition of a physician (Section 1861(r)) must have a UPIN, and that all claims for services ordered or referred by one of these physicians include the name and UPIN of the ordering/referring physician.
Currently, suppliers, physicians, and non-physician practitioners are allowed to bill for diagnostic, radiology, consultation services, and equipment with the use of Surrogate UPIN OTH000. Surrogate UPINs were intended to be used during an interim period when a UPIN has been requested but has not yet been received.
CR4177 announces that CMS will no longer accept the Surrogate UPIN OTH000 to identify the ordering or referring physicians on claims submitted by billers, suppliers, physicians, and non-physician practitioners, effective for dates of service April 1, 2006, and later: (Beneficiary submitted claims and mass immunization claims are excluded.)
- Durable medical equipment (DME) suppliers, physicians, non-physician practitioners, and billers must submit the UPIN assigned to the ordering or referring physician; and
- Medicare carriers and DMERCs will return, as unprocessable, all claims submitted with Surrogate UPIN OTH000.
Implementation
The implementation date for this instruction is April 3, 2006.
Additional Information
For complete details, please see the official instruction issued to your carrier/DMERC regarding this change. That instruction may be viewed at http://www.cms.hhs.gov/Transmittals/downloads/R752CP.pdf on the CMS Web site.
If you need to obtain another physician's UPIN for billing purposes, you may find that UPIN by going to
http://www.upinregistry.com.
If you have any questions, please contact your carrier/DMERC at their toll-free number, which may be found at http://www.cms.hhs.gov/apps/contacts/ on the CMS Web site.
Enactment of the Deficit Reduction Act of 2005
On February 8, 2006, President Bush signed into law the Deficit Reduction Act of 2005(DRA). As of February 10, 2006, CIGNA Government Services will be processing newly received claims under the new law.
Expansion of Coverage for Percutaneous Transluminal Angioplasty (PTA)
Note: This article was revised on February 8, 2006, to clarify that reporting of both 433.30 and 433.10, in either principal diagnosis or secondary diagnosis positions, needs to be done in the same claim as noted in the "Note" box at the top of page 5 of this article. In addition, the Web addresses were changed to conform to the new CMS Web site. All other information remains the same.
Provider Types Affected
Hospitals, physicians, and suppliers billing Medicare carriers or fiscal intermediaries (FIs) for Percutaneous Transluminal Angioplasty (PTA) services provided to Medicare beneficiaries
Provider Action Needed
STOP - Impact to You
MM3811 and related CR3811 announce the expansion of Medicare coverage for PTA of the carotid artery.
CAUTION - What You Need to Know
Effective March 17, 2005, Medicare revised its coverage of PTA of the carotid artery as detailed in this article and CR 3811.
GO - What You Need to Do
If you are a provider of PTA services, be aware of the coverage changes and make certain that your billing staff is aware of the expanded national coverage allowed to Medicare beneficiaries receiving PTA services
Background
Medicare covers PTA of the carotid artery concurrent with carotid stent placement when all the requirements stipulated by the Food and Drug Administration (FDA)-approved policies for Category B Investigational Device Exemption (IDE) clinical trials are met, effective for dates of service on or after July 1, 2001.
PTA of the carotid artery concurrent with the placement of an FDA-approved carotid stent for an FDAapproved indication is covered, when all the requirements stipulated by the FDA-approved policies for postapproval studies are met, for dates of service on or after October 12, 2004.
Expanded Coverage
Effective March 17, 2005, The Centers for Medicare & Medicaid Services (CMS) expanded the coverage of PTA of the carotid artery concurrent with placement of an FDA-approved carotid stent with embolic protection for the following:
- Patients who are at high risk for carotid endarterectomy (CEA) and who also have symptomatic carotid artery stenosis ≥ 70%. Coverage is limited to procedures performed using FDA-approved carotid artery stenting systems and embolic protection devices;
- Patients who are at high risk for CEA and have symptomatic carotid artery stenosis between 50% and 70% in accordance to the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare National Coverage Determination (NCD) Manual, Section 310.1), or according to the NCD on carotid artery stenting (CAS) post-approval studies (Medicare NCD Manual, Section 20.7); and
- Patients who are at high risk for CEA and have asymptomatic carotid artery stenosis ≥ 80% (according to the Category B IDE clinical trials regulation (42 CFR 405.201)), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or according to the NCD on CAS post-approval studies (Medicare NCD Manual, Section 20.7).
Significant Comorbidities
CMS defines high risk patients as those having significant comorbidities and/or anatomic risk factors and are considered by a surgeon to be poor candidates for CEA. The significant comorbidities, include, but are not limited to, those listed in Section 20.7 of the Medicare NCD Manual as follows:
- Congestive heart failure (CHF) class III/IV;
- Left ventricular ejection fraction (LVEF) < 30%;
- Unstable angina;
- Contralateral carotid occlusion;
- Recent myocardial infarction (MI);
- Previous CEA with recurrent stenosis ;
- Prior radiation treatment to the neck; and
- Other conditions that were used to determine patients at high risk for CEA in the prior CAS trials and studies, such as ARCHER, CABERNET, SAPPHIRE, BEACH, and MAVERIC II.
Carotid Artery Stenosis
Symptoms of carotid artery stenosis include carotid transient ischemic attack (distinct focal neurologic
dysfunction persisting less than 24 hours), focal cerebral ischemia producing a non-disabling stroke
(modified Rankin scale < 3 with symptoms for 24 hours or more), and transient molecular blindness
(amaurosis fugax). Patients who have had a disabling stroke (modified Rankin > 3) would be excluded
from coverage.
The appropriate documentation confirming that a patient is at high risk for CEA and records of the patient's symptoms of carotid artery stenosis should be available in the patient medical records prior to performing any procedure.
The degree of carotid artery stenosis should be measured by duplex Doppler ultrasound or carotid artery angiography and recorded in the patient medical records. If the stenosis is measured by ultrasound prior to the procedure, then the degree of stenosis must be confirmed by angiography at the start of the procedure.
If the stenosis is determined to be less than 70% by angiography, the CAS should not proceed.
- Carotid artery stenting with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation,
