May 2005 Part B Medicare Bulletin
Posted May 4, 2005
Table of Contents
- 2nd Quarter Update Part B Not Otherwise Classified Drug Fee Schedule
- Anti-Cancer Chemotherapy for Colorectal Cancer
- April 2005 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing File, Effective April 1, 2005
- Billing for Implantable Automatic Defibrillators for Beneficiaries in a Medicare Advantage (MA) Plan and Use of the QR Modifier to Identify Patient Registry Participation
- Calculating Payment-to-Cost Ratios (PCR) for Purposes of Determining Transitional Corridor Payment under the Outpatient Prospective Payment System (OPPS)
- Claims Status Code/Claims Status Category Code Update
- Clarification for Change Request (CR) 3267
- Diabetes Screening Tests
- Drugs and Biological Excluded as Ususally Self-Administered
- GRAFTJACKET™ Regenerative Tissue Matrix
- Hospice Pre-Election Evaluation and Counseling Services
- Implementation of the Abstract File for Purchased Diganostic Tests/Interpretations (Supplemental to CR 3481)
- Implementation of the Medicare Physician Fee Schedule (MPFS) National Abstract File for Purchased Diagnostic Test and Interpretations
- Information and Education Resources for Medicare Provides, Suppliers, and Physicians
- Information for Providers, Physicians, Pharmicists and Their Staffs About Medicare Prescription Drug Coverage
- Medicare Secondary Payer (MSP) Manual
- Modification to Online Medicare Secondary Payer Questionnaire
- New Contrast Agents Healthcare Common Procedure Coding System (HCPCS) Codes
- New Remittance Advice (RA) Message for Referred Clinical Diagnostic/Purchased Diangnostic Service Duplicate Claims
- Progressive Corrective Action Review J1745
- Revised Manual Language to Item 24G (Days or Units) CMS-1500 Instructions Regarding the Billing of Oxygen and Oxygen Equipment
- Rural Ambulance Protocols Medicare Part B for Idaho, North Carolina & Tennessee
- Skilled Nursing Facility (SNF) Consolidated Billing (CB) as It Relates to Therapy Services
- Surgical Wound Catheter for Post-Operative Pain Control
- Unprocessable Unassigned Form CMS-1500 Claims
- Udpate to the Healthcare Provider Taxonomy Codes (HPTC) Version 5.0
- Xeloda
Information and Education Resources for Medicare Providers, Suppliers, and Physicians
Provider Types Affected
All Medicare physicians, providers, and suppliers
Provider Action Needed
This article is informational only and is intended to notify Medicare physicians and other providers about the information and education resources that the Centers for Medicare & Medicaid Services (CMS) have developed to help meet their Medicare business needs.
Background
One of the goals of CMS is to give Medicare’s 1.2 million physicians and other providers the information they need to understand the program, be aware of changes, and bill correctly. By making information and education resources easily accessible, understandable, and as timely as possible, physicians and other providers will be better able to submit bills correctly the first time, receive reimbursements more quickly, and spend less time dealing with paperwork. All of this can result in more time to spend on patient care.
We are committed to accomplishing this goal by offering Medicare physicians and other providers a variety of educational products and services and using various information delivery systems to reach the broadest and most appropriate audiences possible.
Three-Pronged Provider Information and Outreach Approach
CMS relies on the cooperative efforts of its Medicare contractors, Regional Offices, and Central Office provider communications staff to deliver a seamless information and outreach approach to Medicare physicians and other providers.
1) Medicare Contractors
Medicare contractors, also called fiscal intermediaries and carriers, serve as the primary point of contact for most Medicare physicians and other providers. These contractors provide toll-free telephone lines for inquiries, conduct outreach and education, and often interact with local professional associations. Their outreach and education activities include in-person seminars, bulletins and newsletters, speaker appearances, and quick dissemination of timely information via Web sites and provider-specific electronic ListServs (mailing lists).
If you have questions about the Medicare Program, you should first get in touch with your fiscal intermediary or carrier. To find fiscal intermediary and carrier contact information, please visit: http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
2) CMS Regional Offices
Staff at CMS’ Regional Offices are active with the physician and other provider communities at State and local levels through their relationships with State and local associations and big billers, and through outreach activities such as hosting provider-oriented meetings and furnishing speakers at professional conferences. CMS’ Regional Offices also provide oversight of Medicare contractors and play a key role in resolving issues that physicians and other providers cannot get resolved.
CMS Regional Offices are located at various locations around the country. You can find their contact information at: http://www.cms.hhs.gov/about/regions/professionals.asp
3) CMS Central Office in Baltimore, Maryland
The provider communications staff at the CMS Central Office work closely with both Medicare contractor and Regional Office staff to ensure that consistent and coordinated Medicare information and resources are available to all physicians and other providers. Education and outreach activities from the CMS Central Office focus on accuracy, consistency, and timeliness. Given the hectic schedules of today’s health care professionals, most of our current initiatives are aimed at fostering a “self-service” environment so that physicians and other providers can access information and education 24 hours a day, 7 days a week. As a result, we have significantly increased the use of the Internet as a key tool for continuous-improvement customer service.
Our efforts have resulted in a variety of products and services, such as:
- Medlearn Matters Articles ~ One of the best sources for the latest Medicare information is “Medlearn Matters…Information for Medicare Providers” national articles, which are available at http://www.cms.hhs.gov/medlearn/matters. These articles are designed to give physicians and other providers and their staff easy to understand information related to new and recently changed Medicare rules and policies. On the Medlearn Matters Web page, you’ll find a sortable table for Matters Web page, you’ll find a sortable table for easy access to each article and its corresponding Program instructions, if applicable. You can join the Medlearn Matters listserv to receive electronic notification when new articles are released.
- Medicare Learning Network ~ The Medicare Learning Network (MLN) is the brand name for official CMS physician and other provider educational products and is designed to promote national consistency of Medicare provider information developed for CMS initiatives. Products range from Web-based training courses, comprehensive training guides, brochures, and fact sheets to CD-ROMs and videos. All MLN products are free of charge and can be ordered or downloaded from the Medlearn Web page located at: http://www.cms.hhs.gov/medlearn.
- CMS Provider Web Pages ~ CMS has designed provider-specific Web pages to assist individual physicians and other provider types in obtaining information relevant to them more quickly. These Web pages are a customized, one-stop Web-based resource for the provider, supplier, and physician audience that also includes highlights on items such as new regulations and hot topics, links to general information on enrollment, billing, conditions of participation, publications, education, data, statistics, and links to “specialty” information. We also have Specialty Physician Web Pages where we will continue to add links of special interest to physician specialties. The first Specialty Physician Web Page, “Medicare Information for Anesthesiologists,” is available at: http://www.cms.hhs.gov/physicians/ anesthesiologist/default.asp.
From the CMS Home Page at
http://www.cms.hhs.gov, you can access select physicians and other provider pages from the “Professionals” drop-down menu. You can also see a complete listing of available provider and supplier Web pages by clicking on http://www.cms.hhs.gov/providers or http://www.cms.hhs.gov/suppliers. - Listserv Messages ~ CMS has a number of listservs that transmit important Medicare notices and reminders to subscribers. For example, listservs have been established for most provider- specific Web pages as well as for updates on the Medicare Prescription Drug, Improvement and Modernization Act of 2003, the Medicare Learning Network, and the Quarterly Provider Update. To view and subscribe to one or more listserv, please visit http://www.cms.hhs.gov/mailinglists.
- Open Door Forums ~ CMS is very interested in hearing from and interacting with the physicians and other providers who deliver quality health care to our nation’s beneficiaries. We continue to emphasize our responsiveness through an ongoing series of Open Door Forums that provide an environment for interactive dialogue. Forums are chaired by senior-level Agency officials and co- chaired by CMS Regional Office officials. For more information, please visit http://www.cms.hhs.gov/opendoor.
- Exhibit Program ~ CMS hosts exhibit booths at provider, supplier, and physician association
meetings. The CMS Exhibit Program provides an excellent opportunity for CMS Central and Regional Office staff to have direct contact with the Medicare provider, supplier, and physician communities to listen to issues, concerns, and challenges and to share timely and relevant information. If you are interested in having a CMS exhibit at your national conference, please contact David Clark at dclark@cms.hhs.gov.
Physician and Other Provider Feedback
Although we try our best to be responsive to the Medicare physician and other provider community’s education and information needs, we cannot do it alone. Your feedback on the effectiveness and
usefulness of our educational resources is very important to us as it helps ensure that we are “getting it right.” Please submit your comments or suggestions at http://www.cms.hhs.gov/providers by selecting “Feedback” from the blue template located at the top of the page. There is also a feedback link on the Medlearn Web Pages for your suggestions on new educational products at
http://www.cms.hhs.gov/medlearn/suggestform.asp. We look forward to hearing from you!
Revised Manual Language to Item 24G (Days or Units) CMS-1500 Instructions Regarding the Billing of Oxygen and Oxygen Equipment
Provider Types Affected
Providers and suppliers billing carriers and Durable Medical Equipment Regional Carriers (DMERCs) for oxygen and oxygen equipment
Provider Action Needed
STOP – Impact to You
Suppliers and providers should note that this instruction is based on information contained in Change Request (CR) 3753 regarding revised manual language for oxygen billing instructions for CMS-1500 contained in the Medicare Claims Processing Manual (Pub. 100-04).
CAUTION – What You Need to Know
The language contained in Chapter 26, Section 10.4, Item 24G of the CMS-1500 claim form regarding the billing of oxygen claims is being revised, and the Item 24G billing requirements will include a reference to the actual oxygen billing instructions contained in Chapter 20, Section 130.6 of the Medicare Claims Processing Manual.
GO – What You Need to Do
Please see the Background and Additional Information Sections of this instruction for further details regarding these changes.
Background
The Medicare Claims Processing Manual (Pub. 100-04) language contained in Chapter 26, Section 10.4, Item 24G provides an explanation of how to fill out Item 24G (Days or Units) of the CMS-1500 claim form, and the billing requirements for Item 24G can vary based on the type of service being billed.
The current language explaining the procedures for billing for oxygen is inaccurate and outdated and is removed by CR 3753. The language is being replaced with a direct reference to Chapter 20, Section 130.6 of the same manual that deals with billing for oxygen and oxygen equipment.
The following is the revised wording (bolded and italicized) that is being added to Item 24G (Pub. 100-04, Chapter 26, Section 10.4):
For instructions on submitting units for oxygen claims, see Chapter 20, Section 130.6.
The Medicare Claims Processing Manual (Pub. 100-04,) Chapter 20 (Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS,) Section 130 (Billing for Durable Medical Equipment (DME) and Orthotic/ Prosthetic Devices,) Subsection 130.6 (Billing for Oxygen and Oxygen Equipment) can be found at: http://www.cms.hhs.gov/manuals/104_claims/clm104c20.pdf
Implementation
The implementation date for this instruction is July 1, 2005.
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/manuals/transmittals/comm_date_dsc.asp
From that Web page, look for CR 3753 in the CR NUM column on the right, and click on the file for that CR.
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/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
Information for Providers, Physicians, Pharmacists and Their Staffs About Medicare Prescription Drug Coverage
MMA –Your Important Role
Provider Types Affected
Medicare physicians, institutional providers, pharmacists, and any staff who have contact with Medicare beneficiaries
Provider Action Needed
STOP – Impact to You
On January 1, 2006, a new benefit will be available to the 41 million Americans who receive health insurance coverage through the Medicare program. Medicare Prescription Drug Plans will help reduce the cost of prescription drugs. Your patients may ask you about this new benefit.
CAUTION – What You Need to Know
We need your help to make sure Medicare patients know about and understand this new benefit —information is just a click away. Through Medlearn Matters articles, we will give you access to various levels of information. You decide the level of involvement you want to have in helping Medicare patients.
GO – What You Need to Do
Stay informed, visit: http://www.cms.hhs.gov/medlearn/drugcoverage.asp on the Web. This Web site includes links to all articles in this series and information providers need about the new coverage. At a minimum, refer your Medicare patients to 1.800. MEDICARE and http://www.medicare.gov on the Web.
Background
You and your staff are trusted sources of information for your patients. You may be the first source of
information that Medicare beneficiaries use to explain Medicare Prescription Drug Coverage. Please
encourage your Medicare patients to learn more about this new coverage because it may save them
money on prescription drugs. If a beneficiary fails to actively choose a prescription drug plan, they may miss out on cost savings for prescription drugs. Medicare Prescription Drug Coverage will:
- Help pay for prescriptions;
- Provide extra help for people with limited income and resources; and
- Cover brand name and generic drugs.
CMS will include Medicare Prescription Drug Coverage details in the 2006 Medicare & You Handbook, and send it to beneficiaries in October 2005.
Your Role and Involvement – You Choose
Your interest may range from wanting basic to detailed information on this coverage. For example, if you work in a rural locale, or in areas that serve a large population of beneficiaries with limited income and resources, you may have a greater interest in counseling your patients.
- Basic - You know that Medicare Prescription Drug Coverage exists and where to send people to learn about benefit details. You may display a poster (available later this spring) in your office or clinic, and make beneficiary-focused materials available in your office.
Intermediate - You know more about Medicare Prescription Drug Coverage, such as:
- How beneficiaries can enroll;
- Co-payment amounts;
- Where to find additional help for people with limited income and resources;
- Where to find information on the following Web sites: http://www.medicare.gov
http://www.cms.hhs.gov/medlearn/drugcoverage.asp - How to answer the basic questions.
Advanced - You know detailed information about Medicare Prescription Drug Coverage and the plans available in your area. You, or someone on your staff, can answer detailed questions about the drug benefit. In some cases, you or your staff may counsel beneficiaries on their particular situation and the options that will work best for them.
To Stay Updated on New Information and Educational Resources
- Pay attention to correspondence from your national professional associations — they are part of the information stream from CMS to the community of professionals who serve people with Medicare; sign up for their listservs and read their newsletters.
- Keep current with information from your Medicare fee-for-service claims processing contractor;
bookmark their Web site, read their bulletins, and register to receive electronic listserv messages. - Bookmark and visit the provider educational Web page on Medicare Prescription Drug Coverage,
http://www.cms.hhs.gov/medlearn/drugcoverage.asp on the Web. - Register to receive listserv email messages to alert you when new Medlearn Matters articles have been released on the new drug benefit (and other Medicare information); register at http://www.cms.hhs.gov/medlearn/matters on the Web.
- Participate in CMS Open Door Forums, to hear from and ask questions of CMS leadership on topics of interest to your particular provider type; for information about these forums visit http://www.cms.hhs.gov/opendoor on the Web.
Get Your Staff Involved
In addition, inform members of your staff who interact with Medicare patients every day about the
information in this article:
- Physicians - supply this information to nursing and front office staff.
- Hospitals - supply this information to nursing, discharge planning, financial, and emergency room staff.
- Pharmacists - supply this information to your pharmacy technicians and front counter staff.
If you or your staff are willing to further advise and counsel people with Medicare, CMS will have tools to help you do this on http://www.cms.hhs.gov/partnerships (toolkit available by April 1, 2005).
Summary
CMS asks you to:
- Respond to questions from your patients in a way that encourages them to seek more information from the Medicare Program;
- Inform members of your staff who interact with Medicare patients about the information resources available to them, and where they may refer patients to learn more about Medicare Prescription Drug Coverage; and
- At a minimum, refer your Medicare patients who are looking for information on Medicare Prescription Drug Coverage to 1.800.MEDICARE or http://www.medicare.gov on the Web.
Unprocessable Unassigned Form CMS-1500 Claims
NOTE: This article was revised on March 18, 2005, because CR 3500 was reissued. The only changes to the article are to show the new CR release date and transmittal number. No other changes were made to the article.
Provider Types Affected
Physicians, providers, and suppliers who bill Medicare carriers, including Durable Medical Equipment Regional Carriers (DMERCs)
Provider Action Needed
No provider action is needed. This instruction makes necessary changes to ensure consistency in the
handling of Medicare Part B claims and to ensure that HIPAA noncompliant data is not transmitted to
Coordination of Benefits (COB) trading partners.
Provider Impact
Formerly, unassigned claims were denied with appeal rights. However, this instruction notifies physicians, providers, and suppliers that unassigned Centers for Medicare & Medicaid Services (CMS) Form 1500 claims and electronic interface equivalents that are incomplete or contain invalid information will be returned as unprocessable to the submitters for correction or resubmission. It is important to note that as an unprocessable, when the claim is returned, there are no appeal rights.
When the claims are corrected and then processed, electronic crossover claims can be sent to COB trading partners that are HIPAA compliant and the COB secondary payer claims can be processed for Medicare beneficiaries.
Background
The Medicare Claims Processing Manual (Pub. 100-04) provides instructions for handling Medicare claims, including Part B Form CMS-1500 claims that have incomplete or invalid information. Such claims are to be returned without appeal rights. See Pub. 100-04, Chapter 1 (General Billing Requirements), Section 80.3.1 (Incomplete or Invalid Claims Processing Terminology) at: http://www.cms.hhs.gov/manuals/104_claims/clm104c01.pdf
Currently, the instructions for Form CMS-1500 claims are:
- Specified to apply only to assigned Part B claims, and
- Silent as to unassigned CMS-1500 claims.
As a result, many Part B carriers and DMERCs have been denying unassigned CMS-1500 claims with appeal rights and not returning these claims as unprocessable without appeal rights.
In addition, when denying these claims, the carriers/DMERCs have been sending to COB secondary payers electronic crossover claims containing Health Insurance Portability and Accountability Act of 1996 (HIPAA) noncompliant claims data (such as diagnosis codes and procedure codes that are not part of the standard code sets).
Under HIPAA rules, COB trading partners are not required to process claims that are not HIPAA compliant, and in claims with multiple service lines, the entire claim might be rejected. The inclusion of HIPAA noncompliant data has resulted in some COB trading partners refusing to process such crossover claims for Medicare beneficiaries.
Implementation
The implementation date for this instruction is July 5, 2005.
Additional Information
The Medicare Claims Processing Manual (Pub. 100-04), Chapter 1, has been revised and is included as an attachment to the official instruction released to your carrier. You may view that instruction at:
http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
From that Web page, look for CR 3500 in the CR NUM column on the right, and click on the file for that CR.
If you have any questions, please contact your carrier/DMERC at their toll-free number found at: http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
Implementation of the Abstract File for Purchased Diagnostic Tests/Interpretations (Supplmental to CR 3481)
Provider Types Affected
Physicians and Independent Diagnostic Testing Facilities (IDTFs) billing Medicare carriers for purchased diagnostic tests/interpretations
Provider Action Needed
STOP
Related CR 3694 replaces the requirement in CR 3481 instructing carriers to pay physicians for diagnostic tests and interpretations performed outside of the local carrier’s jurisdiction.
CAUTION
All other instructions in CR 3481 remain in effect.
GO – What You Need to Do
Medicare carriers will continue to pay physicians at the local rate, until further notice, for services
purchased outside of the carrier’s jurisdiction when submitted by a physician enrolled in the carrier’s jurisdiction. Physicians should continue to report their name and service facility location on claims for purchased tests/interpretations performed outside of the local carrier’s jurisdiction. Physicians use their own PIN to bill for both the purchased portion of the test and the portion of the test that they performed. Suppliers (laboratories and IDTFs) are to bill local carriers regardless of where the tests are performed and carriers are to pay suppliers based on ZIP codes.
NOTE: Physicians should continue to follow the billing instructions provided in Change Request 3630 (Transmittal 415, issued on December 23, 2004) until further notice.
NOTE: This article was revised on March 18, 2005, to include the following message:
Some Medicare carriers use a claims processing system (known as the ViPS Medicare Part B system) to process Medicare claims. These carriers will not implement this change at this time. Those carriers are:
- Empire Medicare Services
- Blue Cross Blue Shield of Kansas
- Triple-S
- GHI
Until further notice, physicians and independent diagnostic testing facilities who bill these carriers should continue to follow the billing instructions provided in CR 3630 issued on December 23, 2004. That CR can be found at: http://www.cms.hhs.gov/manuals/pm_trans/R415CP.pdf
Also, a corresponding Medlearn Matters article related to CR 3630 may be found at: http://ww.cms.hhs.gov/medlearn/matters/mmarticles/2005/MM3630.pdf
Background
CR 3481 instituted a national abstract file of the Medicare Physician Fee Schedule (MPFS) containing
Healthcare Common Procedure Coding System (HCPCS) codes billable as purchased diagnostic tests and interpretations for every locality throughout the country. Effective April 1, 2005, suppliers, including laboratories, physicians, and IDTFs, are to bill their local carrier for purchased diagnostics tests and interpretations, regardless of the location where the service was furnished. However, until further notice, CMS is delaying the implementation of the billing instructions specified in CR 3481 for purchased diagnostic service claims submitted by physicians due to a locality reporting issue.
Effective April 1, 2005, carriers should price claims based on the ZIP code of the location where the service was rendered when submitted by a laboratory or IDTF, using a CMS-supplied abstract file of the MPFS containing the HCPCS codes that are payable under the MPFS as either a purchased test or interpretation for the calendar year. Until further notice, carriers should pay the local rate for purchased interpretation claims when submitted by a physician. Carriers should accept and process claims when billed by suppliers enrolled in the carrier’s jurisdiction, regardless of the location where the service was furnished. Carriers should allow claims submitted by an IDTF if the IDTF has previously enrolled to bill for purchased diagnostic test components it performs.
Implementation
The implementation date for this instruction is April 4, 2005.
Additional Information
To view the official instruction issued to your carrier, visit: http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
Once at that site, look for CR 3694 in the CR NUM column on the right, and click on the file for that CR.
If you have any questions, please contact your carrier at their toll-free number, which can be found at:
http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
Implementation of the Medicare Physician Fee Schedule (MPFS) National Abstract File for Purchased Diagnostic Tests and Interpretations
NOTE: This article was revised on March 18, 2005, to include the following message:
Some Medicare carriers use a claims processing system (known as the ViPS Medicare Part B system) to process Medicare claims. These carriers will not implement this change at this time. Those carriers are:
- Empire Medicare Services
- Blue Cross Blue Shield of Kansas
- Triple-S
- GHI
Until further notice, physicians, laboratories, and independent diagnostic testing facilities who bill these carriers should continue to follow the billing instructions provided in CR3630 issued on December 23, 2004.
That CR can be found at: http://www.cms.hhs.gov/manuals/pm_trans/R415CP.pdf
Also, a corresponding Medlearn Matters article related to CR3630 may be found at: http://www.cms.hhs.gov/MedlearnMattersArticles/downloads/MM3630.pdf.
Provider Types Affected
Physicians, laboratories, and independent diagnostic testing facilities.
Provider Action Needed
This instruction implements a national abstract file of the Medicare Physician Fee Schedule (MPFS)
containing Healthcare Common Procedural Coding System (HCPCS) codes billable as purchased
diagnostic tests and interpretations, for every locality throughout the country.
Effective April 1, 2005, suppliers, including laboratories, physicians, and independent diagnostic testing facilities, must bill their local carrier for purchased diagnostics tests and interpretations, regardless of the location where the service was furnished. The Centers for Medicare & Medicaid Services (CMS) recognizes that the abstract file for purchased diagnostic tests/interpretations may not include all diagnostic services that may be purchased. Suppliers may request to add other HCPCS codes that are billable as purchased services to this file by sending a note to CMS at the following address:
Centers for Medicare & Medicaid Services
Centers for Medicare Management/Provider Billing Group/Division of Supplier Claims Processing
7500 Security Blvd.
Baltimore, MD 21244
CMS will review these requests periodically to determine whether code additions or deletions are needed, and will make updates to the abstract file in conjunction with the MPFS quarterly releases. The billing physicians/suppliers should be aware that they are responsible for ensuring that the physician or supplier that furnished the purchased test/interpretation is enrolled with Medicare and is in good standing (i.e., the physician/supplier is not sanctioned, barred, or otherwise excluded from participating in the Medicare program).
The Office of Inspector General (OIG) maintains a database of information concerning parties that are excluded from participation in the Medicare, Medicaid, or other Federal health programs. The OIG exclusions database is available to the public on the OIG Web site at the following address: http://www.oig.hhs.gov/fraud/exclusions.html
Suppliers may access this database, or use another available source, to determine whether a physician/supplier is eligible to participate with Medicare prior to billing for a purchased diagnostic test or interpretation.
Background
CR 3481 implements a national abstract file of the MPFS containing HCPCS codes billable as a purchased diagnostic test/interpretation, for every locality throughout the country. Effective with the implementation of the abstract file on April 4, 2005, carrier jurisdiction rules for purchased diagnostic tests/interpretations will be changed to allow suppliers to bill their local carriers for these services and receive the correct payment amount, regardless of the location where the service was performed. Carrier jurisdictional pricing rules for all other services payable under the MPFS will remain in effect.
Implementation
The implementation date for this instruction is April 4, 2005.
Additional Information
The revised portions of the Medicare Claims Processing Manual related to this change are attached to the official instruction issued to your carrier. That instruction may be found at: http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
Once at that site, look for CR 3481 in the CR NUM column on the right, and click on the file for that CR. If you have any questions, please contact your carrier at their toll-free number, which can be found at:
http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
Xeloda
Effective April 15, 2005, CIGNA Government Services will consider capecitabine (Xeloda) as equivalent to IV 5-FU when used in combination with bevacizumab for the treatment of metastatic colon cancer. Capecitabine would be used in place of IV 5-FU in this scenario.
Clarification for Change Request (CR) 3267
Note: This article was revised on March 8, 2005, to show the correct transmittal number.
Provider Types Affected
Hospitals and independent laboratories billing Medicare carriers or fiscal intermediaries (FIs) for laboratory services
Provider Action Needed
This article contains information provided in Change Request (CR) 3729 that clarifies policies previously issued in CR 3267 (Transmittal 228, July 16, 2004). It also informs hospitals and independent labs that 1) they may use collected and retained Medicare Secondary Payer (MSP) information for the billing of nonface-to-face reference lab services, and 2) they are required to collect MSP information from the beneficiary when billing for face-to-face encounters with Medicare patients for lab services.
Background
Treatment of hospitals for certain services under Medicare Secondary Payer (MSP) Provisions of the
Medicare Prescription Drug Improvement & Modernization Act of 2003 (MMA) states:
“(a) IN GENERAL. – The Secretary shall not require a hospital (including a critical access hospital) to ask questions (or obtain information) relating to the application of section 1862(b) of the Social Security Act (relating to Medicare Secondary Payer provisions) in the case of reference lab services described in
subsection (b), if the Secretary does not impose such
requirement in the case of such services furnished by an independent laboratory.”
“(b) REFERENCE LABORATORY SERVICES DESCRIBED – Reference laboratory services described in this subsection are clinical laboratory diagnostic tests (or the interpretation of such tests, or both) furnished without a face-to-face encounter between the individual entitled to benefits under part A or enrolled under part B, or both, and the hospital involved and in which the hospital submits a claim only for such test or interpretation.” The Centers for Medicare & Medicaid Services (CMS) will not require independent reference laboratories to collect MSP information in order to bill Medicare for reference laboratory services as described in subsection (b) above.
Therefore, pursuant to the MMA (Section 943), CMS will not require hospitals to collect MSP information in order to bill Medicare for reference laboratory services (as described in subsection (b) above). This policy, however, will not be a valid defense to Medicare’s right to recover when a mistaken payment situation is later found to exist.
Therefore, in situations where hospital and independent labs have already collected and retained MSP information for beneficiaries, they may use the collected and retained MSP information for the billing of non-face-to-face reference lab services.
In addition, in situations when there is a face-to-face encounter with the beneficiary, hospitals and independent labs are required to collect MSP information from the beneficiary when billing for face to-face lab services.
This clarification should have been made as part of CR 3267 (which clarified CR 3064, Transmittal 11, February 27, 2004).
Implementation
The implementation date for this instruction is June 6, 2005.
Additional Information
CR 3267 (Transmittal 228, July 16, 2004) can be reviewed at the following CMS Web site:
http://www.cms.hhs.gov/manuals/pm_trans/R228CP.pdf
CR 3064, Transmittal 11, February, 27, 2004) can be reviewed at the following CMS Web site:
http://www.cms.hhs.gov/manuals/pm_trans/R11MSP.pdf
The Medicare Secondary Payer Manual (Pub. 100-5) can be found at the following CMS Web site:
http://www.cms.hhs.gov/manuals/105_msp/msp105index.asp
The Medicare Claims Processing Manual (Pub. 100-04), Chapter 26 (Completing and Processing Form CMS-1500 Data Set) provides instructions on how to process reference lab claims submitted on Form CMS-1500, and can be found at the following CMS Web site: http://www.cms.hhs.gov/manuals/104_claims/clm104c26.pdf
After you get to Chapter 26, click on Section 10.2 (Items 1-11 - Patient and Insured Information) in the Table of Contents.
For complete details, please see the official instruction issued to your carrier/intermediary regarding this change. That instruction may be viewed by going to:
http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
From that Web page, look for CR 3729 in the CR NUM column on the right, and click on the file for that CR.
If you have any questions, please contact your carrier/intermediary at their toll-free number, which may be found at: http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
Claims Status Code/Claims Status Category Code Update
Provider Types Affected
All providers submitting Health Care Claim Status Transactions to Medicare carriers, including Durable Medical Equipment Carriers (DMERCs), and Fiscal Intermediaries (FIs)
Provider Action Needed
This is a reminder item regarding the periodic update of certain code sets used as a result of the Health
Insurance Portability and Accountability Act (HIPAA). Effective July 1, 2005, the Medicare Claims processing system will update its lists of Health Care Claims Status Codes and Health Care Claims Status Category Codes with all applicable code changes posted online with the “new as of 10/04” and prior date designations.
Background
Under HIPAA, code sets that characterize a general administrative situation, rather than a medical
condition or service, are referred to as non-clinical or non-medical code sets.
Claim Status Category Codes and Claim Status Codes are used in the Health Care Claim Status Response (277) transaction:
- Claim Status Category Codes indicate the general payment status of the claim.
- Claim Status Codes provide more detail about the status communicated in the general Claim Status Category Codes.
These codes are available online at: http://www.wpc-edi.com/codes/Codes.asp
Additional Information
The official instruction issued regarding this change can be found at: http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
On the above page, scroll down the CR NUM column on the right to find the link for CR 3715. Click on the link to open and view the file for the CR.
If you have questions regarding this issue, you may also contact your carrier or intermediary at their toll free number, which may be found at: http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
Diabetes Screening Tests
Provider Types Affected
All Medicare providers billing Medicare carriers or fiscal intermediaries for diabetes screening tests for Medicare patients
Provider Action Needed
STOP – Impact to You
This article provides further guidance and clarification of new Medicare coverage rules for diabetes screening tests performed on or after January 1, 2005.
CAUTION – What You Need to Know
The amount of testing covered by Medicare for qualified individuals is changed to one screening test every six months for individuals diagnosed with pre-diabetes and one screening test every twelve months for individuals not diagnosed with prediabetes or who were never tested before.
GO – What You Need to Do
Please refer to the Background and Additional Information sections of this article for further details.
Background
This coverage is mandated by Section 613 of the Medicare Prescription Drug Improvement and
Modernization Act of 2003 (MMA).
Initially, coverage was provided for two screening tests per calendar year for individuals diagnosed with pre-diabetes, and one screening test per year for individuals previously tested who were not diagnosed with pre-diabetes, or who have never been tested. This article and related CR 3677 clarify that, for individuals diagnosed with pre-diabetes, the two screening tests per year are further limited to one screening test every six months. And, providers should note that these tests for individuals with a pre-diabetes diagnosis must be billed with a V77.1 diagnosis code and a “TS” modifier to reflect follow up service.
Any individual with one (1) of the following risk factors for diabetes is eligible for this benefit:
- Hypertension
- Dyslipidemia
- Obesity (with a body mass index greater than or equal to 30 kg/m2), or
- Previous identification of elevated impaired fasting glucose or glucose intolerance.
Or, an individual with any two (2) of the following risk factors is also eligible for this benefit: - Overweight (a body mass index >25, but <30kg/m2)
- A family history of diabetes
- Age 65 years or older
- A history of gestational diabetes mellitus or giving birth to a baby weighing > 9 lbs.
Effective for services performed on or after January 1, 2005, Medicare will pay for diabetes screening tests under the Medicare Clinical Laboratory Fee Schedule. To indicate that the purpose of the test(s) is for diabetes screening, a screening diagnosis code is required in the diagnosis section of the claim.
The following Health Care Common Procedure Coding System (HCPCS) Codes for Diabetes Screening are to be billed for diabetes screening:
- 82947 – Glucose, quantitative, blood (except reagent strip)
- 82950 – Post-glucose dose (includes glucose)
- 82951 – Glucose Tolerance test (GTT), three specimens (includes glucose)
Providers submitting pre-diabetes and diabetes screening claims should note that claims must contain the appropriate HCPCS codes listed above along with a diagnosis code of V77.1.
No coverage is permitted under the MMA benefit for individuals previously diagnosed as diabetic since these individuals do not require screening. Other diabetes screening blood tests for which the Centers for Medicare & Medicaid Services (CMS) has not specifically indicated national coverage continue to be noncovered.
CMS also provides the following definitions for the purpose of this article:
Diabetes: diabetes mellitus, a condition of abnormal glucose metabolism diagnosed from a fasting blood sugar > 126 mg/dL on 2 different occasions; a 2-hour post-glucose challenge > 200 mg/dL on 2 different occasions; or a random glucose test > 200 mg/dL for an individual with symptoms of uncontrolled diabetes.
Pre-diabetes: abnormal glucose metabolism diagnosed from a previous fasting glucose level of 100 to125 mg/dL, or a 2-hour post-glucose challenge of 140 to 199 mg/dL. The term “pre-diabetes” includes impaired fasting glucose and impaired glucose tolerance.
Post-glucose challenge test: an oral glucose tolerance test with a glucose challenge of 75 gms. of glucose for non-pregnant adults, or a 2-hour post-glucose challenge test alone.
Implementation
The implementation date for this article is April 4, 2005. It applies to services furnished on or after January 1, 2005.
Additional Information
Updated manual instructions are included in the official instruction issued to your carrier or fiscal intermediary and can be found at: http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
From that Web page, look for CR 3677 in the CR NUM column on the right, and click on the file for that CR.
If you have any questions, contact your carrier or intermediary at their toll free number, which may be found at: http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
Update to the Healthcare Provider Taxonomy Codes (HPTC) Version 5.0
Provider Types Affected
Providers who bill Carriers including Durable Medical Equipment Regional Carriers (DMERCs)
Provider Action Needed
STOP – Impact to You
CMS has released the summary of changes reflected in the Health Care Provider Taxonomy Code (HCPT) list version 5.0. Medicare carriers and DMERCs will update their HPTC tables with this new version effective on April 1, 2005.
CAUTION – What You Need to Know
The Health Insurance Portability and Accountability Act (HIPAA) requires that submitted data, which is part of a named code set, be valid data from that code set. Claims accepted with invalid data are non-compliant.
GO – What You Need to Do
Please review the information included here and stay current on all HIPAA requirements to assure timely processing of your claims.
Background
Under HIPAA, code sets that characterize a general administrative situation, rather than a medical condition or service, are referred to as non-clinical or non- medical code sets. The Provider Taxonomy code set is an external non-medical data code set designed for use in classifying health care providers according to provider type or practitioner specialty in an electronic environment, specifically within the American National Standards Institute (ANSI) Accredited Standards Committee (ASC) health care transaction.
HIPAA requires that submitted data, which is part of a named code set, must be valid data from that code set. The health care provider taxonomy is a named code set in the 837 professional implementation guide, thus carriers must validate the inbound taxonomy codes against their internal HPTC tables.
The HPTCs are updated twice per year, in April and October. The summary of changes for Version 5.0 is noted in the table below:
| TYPE OF CHANGE | PROVIDER TAXONOMY VALUE CODE |
| Additions | • 390200000X • 261QM1103X • 291900000X • 332000000X • 341800000X • 3418M1120X • 3418M1110X • 3418M1130X |
| Revisions | • 261QM1101X • 261QM1100X • 261QM1102X • 2865M2000X • 2865X1600X • 3416A0800X • 3416L0300X • 3416S0300X |
| Inactivation (will be deleted in future versions) | • 2865C1500X |
The HPTC code list is available in two forms from the Washington Publishing Company:
http://www.wpc-edi.com/codes/taxonomy
- A free Adobe PDF download or
- An electronic representation of the list which will facilitate automatic loading of the code set. This
version is available for purchase.
Additional Information
The official instruction issued regarding this change can be found at: http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
On the above page, scroll down while referring to the CR NUM column on the right to find the link for CR 3716. Click on the link to open and view the file for the CR.
If you have questions regarding this issue, you may also contact your carrier/ DMERC at their toll free number, which may be found at: http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
New Remittance Advice (RA) Message for Referred Clinical Diagnostic/Purchased Diagnostic Service Duplicate Claims
NOTE: This article was revised on March 17, 2005, to reflect a change to CR 3679, which was reissued on February 25, 2005. The CR 3679 was modified to show that the effective date of this change applies to claims processed on or after July 1, 2005, without regard to the date of service on the claim.
Provider Types Affected
Physicians/suppliers who bill Medicare carriers (excluding DMERCs) for referred clinical diagnostic
laboratory and purchased diagnostic services.
Provider Action Needed
STOP – Impact to You
Effective April 1, 2005 a claim for a referred clinical diagnostic/purchased diagnostic service that is
identified as duplicate will be denied. For full details of this edit, please see Medlearn Matters article
MM3551 at: http://www.cms.hhs.gov/MedlearnMattersArticles/downloads/MM3551.pdf
CAUTION – What You Need to Know
Effective with claims processed on or after July 1, 2005, CMS will implement a new Remittance
Advice (RA) message for such duplicate claims. Carriers will use the following remark code on
remittance advice notices generated for a referred clinical diagnostic/purchased diagnostic service
claim line item denied as a duplicate of a previously paid service: “Your claim for a referred clinical
diagnostic/purchased diagnostic service cannot be paid because payment has been made for this service in another carrier jurisdiction.”
GO – What You Need to Do
Be ready to accept this new remark code indicating a duplicate claim submission.
Background
Effective April 1, 2005, the Centers for Medicare & Medicaid Services (CMS) will implement a new Common Working File (CWF) edit to check for duplicate claims for referred clinical diagnostic laboratory services and purchased diagnostic services submitted by physicians/suppliers to more than one carrier.
(Per Transmittal 124, Change Request 3551, published on October 29, 2004 and described in Medlearn Matters article MM3551)
As a reminder, claims submitted for referred clinical diagnostic/purchased diagnostic services will be considered duplicate when:
- The claims contain different carrier numbers; AND
- All of the data matches on the following claim fields:
- Beneficiary Name
- Beneficiary Health Insurance Claim Number (HICN)
- Current Procedural Terminology (CPT)/Healthcare Common Procedure Coding System (HCPCS) Code
- Date of Service
- CPT/HCPCS Code Modifier.
The CWF duplicate claim edit will apply only to:
- Claims containing a CPT code that is included on the clinical laboratory fee schedule (available online at: http://www.cms.hhs.gov/suppliers/clinlab/default.asp, Clinical Laboratory Information Resource for Medicare); OR
- An HCPCS code that is included on the Abstract File for Purchased Diagnostic Tests/Interpretations to be implemented in April 2005.
Effective for claims processed on or after July 1, 2005, CMS will implement a new Remittance Advice (RA) message for claim items denied due to the CWF duplicate claim edit for referred clinical diagnostic/purchased diagnostic service claims:
- Carriers will use the following remark code on remittance advice notices generated for a referred clinical diagnostic/purchased diagnostic service claim line item denied as a duplicate of a previously paid service: “Your claim for a referred clinical diagnostic/purchased diagnostic service cannot be paid because payment has been made for this service in another carrier jurisdiction.”
Additional Information
The official instruction issued to the carrier regarding this change can be found at: http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
On the above page, scroll down while referring to the CR NUM column on the right to find the link for CR 3679. Click on the link to open and view the file for the CR. CR 3551 may be accessed at: http://www.cms.hhs.gov/manuals/pm_trans/R124OTN.pdf
If you have questions regarding this issue, you may also contact your carrier at their toll free number, which may be found at: http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
GRAFTJACKET™ Regenerative Tissue Matrix The GRAFTJACKET™
Regenerative Tissue Matrix is processed from donated human skin supplied from U.S. tissue banks utilizing the guidelines of the American Association of Tissue Banks (AATB) and the Food and Drug Administration’s (FDA) applicable rules and regulations. The allograft skin is minimally processed to remove epidermal and dermal cells through a patented method while preserving the remaining bioactive components and structure of dermis. The resulting allograft serves as a framework to support cellular repopulation and vascularization.
The GRAFTJACKET™ matrix is used for the repair or replacement of damaged or inadequate integumental tissue. It is contraindicated for use in any patient in whom soft tissue implants are contraindicated. These patients and conditions include: Patients diagnosed with autoimmune connective tissues diseases; infected or nonvascular surgical sites, unless specifically prescribed by a physician; sensitivity to specific antibiotics listed on the package; any pathology that would limit the blood supply and compromise healing; poor nutrition and/or poor general medical condition.
- In the absence of a National Coverage Determination (NCD) or Local Coverage Determination (LCD), Medicare evaluates services individually.
- Pending the release of any additional statements or policies, GRAFTJACKET™ will be considered for payment for its FDA-approved indication and based on medical reasonableness and necessity.
- For the application, providers may use the CPT code 15350 (application of allograft, skin; 100 sq cm or less) and the add-on code 15351 (application of allograft, skin; each additional 100 sq cm), as applicable. It is possible that additional instructions about this will be released later.
- For the use of this product in a physician’s office, HCPCS code J7344 (dermal tissue, of human origin, with or without other bioengineered or processed elements, without metabolically active elements, per square centimeter) applies.
- When scheduling patients, providers must make every effort to avoid wastage and to use the material efficiently.
- The medical necessity and extent of any billed wound preparation/debridement services must be carefully documented in the patient’s medical record and made available to Medicare for review upon request.
- Generally, an evaluation and management service (E/M) is not billable. This is particularly true when the grafting does not take place during the initial encounter. Reimbursement for minor surgical procedures includes payment for an element of assessment, which cannot be billed separately. However, if evaluation and management services beyond this inherent evaluative component are medically reasonable, necessary, and appropriately documented, they can be billed using an E/M code with modifier-25 appended.
- Currently, Medicare considers the GRAFTJACKET™ XPRESS product as investigational.
Skilled Nursing Facility (SNF) Consolidated Billing (CB) as It Relates to Therapy Services
Provider Types Affected
Skilled Nursing Facilities (SNFs), physicians, practitioners, physical and occupational therapists, speechlanguage pathologists, rehabilitation agencies, hospitals, home health agencies
Provider Action Needed
This article is informational only and describes SNF Consolidated Billing (CB) as it applies to physical and occupational therapies and speech-language pathology services furnished to SNF residents during a Part A covered stay, residents of a Medicare-certified SNF who are not eligible for Part A care, and beneficiaries who reside in the non-certified portion of a nursing home.
Note: The SNF CB requirement makes the SNF itself responsible for including on the Part A bill that it submits to its Medicare intermediary almost all of the services that a resident receives during the course of a Medicare-covered stay, except for a small number of services that are specifically excluded from this provision. These “excluded” services can be separately furnished to the resident and billed under Medicare Part B by a variety of outside sources. These sources can include other providers of service (such as hospitals), which would submit the bill for Part B services to their Medicare intermediary, as well as practitioners and suppliers who would generally submit their bills to a Medicare Part B carrier. (Bills for certain types of items or equipment would be submitted by the supplier to their Medicare durable medical equipment regional carrier (DMERC.)
Background
When the SNF Prospective Payment System (PPS) was introduced in 1998, it changed not only the way SNFs are paid, but also the way SNFs must work with suppliers, physicians, and other practitioners.
Consolidated billing assigns to the SNF itself the Medicare billing responsibility for virtually all of the services that the SNF’s residents receive during the course of a covered Part A stay. A covered Part A stay occurs when a beneficiary meets all of the requirements for coverage under Part A’s extended care benefit, and resides in an institution or part thereof that is Medicare-certified as an SNF. Payment for this full range of services is included in the SNF PPS global per diem rate.
The only exceptions are services specifically excluded from this consolidated billing provision, which remain separately billable to Medicare Part B by the entity that actually furnished the service.
The law specifically provides that physical therapy (PT), occupational therapy (OT), and speechlanguage pathology (SLP) services are not excluded from consolidated billing (Section 1888(e)(2)(A)(ii) of the Social Security Act and regulations at 42 CFR 411.15(p)(1)(i)). (References in this article to therapy cover only PT, OT, and SLP services.)
(See Medlearn Matters Special Edition article SE0431 for a detailed overview of SNF consolidated billing, including a section on services excluded from SNF consolidated billing.) This article can be found at: http://www.cms.hhs.gov/MedlearnMattersArticles/downloads/SE0431.pdf
The consolidated billing legislation is very emphatic that PT, OT, and SLP services furnished to SNF residents are always subject to consolidated billing. This applies even when a resident receives the therapy during a non-covered stay in which a beneficiary who is not eligible for Part A extended care benefits still resides in an institution (or part thereof) that is Medicare-certified as a SNF. The legislation also applies regardless of whether or not the services are performed by, or under the supervision of, a practitioner (such as a physician) whose services would otherwise be excluded from consolidated billing.
Therapy services that are furnished to residents of a Medicare-certified SNF are subject to the SNF consolidated billing provision. Payment for therapy services furnished during a covered Part A stay is included in the SNF’s global per diem PPS rate.
In a non-covered SNF stay, the beneficiary may be eligible for coverage of individual medical and other health services under Part B. Since the beneficiary still resides in a Medicare-certified institution (or part thereof) the therapy services are subject to the SNF consolidated billing provision. Under this provision, the claims for therapy services furnished during a non-covered SNF stay must be submitted to Medicare by the SNF itself. The SNF is responsible for reimbursing the provider. The SNF would bill its fiscal intermediary and be reimbursed under the Medicare fee schedule.
When a beneficiary resides in a nursing home (or part thereof) that is not certified as an SNF by Medicare, the Part A extended care benefit cannot cover the beneficiary’s stay. However, the beneficiary may still be eligible for Part B coverage of certain individual services, including therapy. In this case, the beneficiary is not considered an SNF resident for Medicare billing purposes, and the therapy services are not subject to consolidated billing. Either the therapy provider or the facility may bill the Medicare carrier for Part B directly.
Additional Information
See Medlearn Matters Special Edition SE0431 for a detailed overview of SNF CB. This article lists services excluded from SNF CB and can be found at:
http://www.cms.hhs.gov/MedlearnMattersArticles/downloads/SE0431.pdf
The Centers for Medicare & Medicaid Services (CMS) Medlearn Consolidated Billing Web site can be found at: http://www.cms.hhs.gov/medlearn/snfcode.asp
It includes the following relevant information:
- General SNF consolidated billing information;
- HCPCS codes that can be separately paid by the Medicare carrier (i.e., services not included in consolidated billing);
- Therapy codes that must be consolidated in a non- covered stay; and
- All code lists that are subject to quarterly and annual updates and should be reviewed periodically for the latest revisions.
The SNF PPS Consolidated Billing Web site can be found at: http://www.cms.hhs.gov/providers/snfpps/cb
It includes the following relevant information:
- Background;
- Historical questions and answers;
- Links to related articles; and
- Links to publications (including transmittals and Federal Register notices).
April 2005 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing File, Effective April 1, 2005, and New January 2005 Quarterly ASP File
Provider Types Affected
All Medicare providers
Provider Action Needed
STOP – Impact to You
CR 3667 discusses updates to the new methodology of paying for Medicare Part B covered drugs not paid on the basis of cost or prospective payment.
CAUTION – What You Need to Know
Effective January 1, 2005, Part B covered drugs and biologicals (that are not paid on a cost or prospective payment basis) are paid based on the new Average Sales Price (ASP) drug payment system, described below.
GO – What You Need to Do
Make sure that your billing staffs are aware of these changes.
Background
The Medicare Modernization Act of 2003 (MMA), Section 303(c), revises the methodology of paying for Part B covered drugs and biologicals that are not paid on a cost or prospective payment basis. Effective January 1, 2005, these drugs are paid based on the new Average Sales Price (ASP) drug payment methodology.
The ASP file, used in the ASP methodology, is based on data CMS receives quarterly from manufacturers. Each quarter, the Centers for Medicare & Medicaid Services (CMS) will update your carrier and Fiscal Intermediary (FI) payment allowance limits with the ASP drug pricing files based on these manufacturers’ data.
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, and CMS will update the payment allowance limits quarterly. However, there are exceptions to this general rule as summarized below:
- For blood and blood products (with certain exceptions like blood clotting factors), payment allowance limits are determined in the same manner they were determined on October 1, 2003. Specifically, 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.
- 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 will not be updated in 2005.
- For influenza, pneumococcal, and hepatitis B vaccines, payment allowance limits are 95 percent of the AWP as reflected in the published compendia. The payment allowance limits will be updated on a quarterly basis.
- 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 payment limit based on WAC, carriers/FIs will follow the methodology specified in the Medicare Claims Processing Manual for calculating the AWP, but substitute WAC for AWP. Please see Pub. 100-04, Chapter 17 (Drugs and Biologicals) at the following CMS Web site: http://www.cms.hhs.gov/manuals/104_claims/clm104c17.pdf. The payment limit is 100 percent of the WAC for the lesser of the lowest brand or median generic. Your carrier or FI 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 carrier/FI or via posting an MS Excel file on the CMS Web site. If the payment limit is available from CMS, carriers/FIs will substitute CMS-provided payment limits for pricing based on WAC or invoice pricing.
- For new drugs and biologicals not included in the ASP Medicare Part B Drug Pricing File or NOC Pricing File, payment allowance limits are based on 106 percent of the WAC. This policy applies only to new drugs that were first sold on or after December 1, 2004.
The April 2005 and new January 2005 ASP drug pricing files will contain three decimal places in the currency fields. In addition, the new January file contains revised payment limits for some drugs. The codes with a revised payment limit are identified in the column titled “Notes.”
The absence or presence of a HCPCS code and its associated payment limit in the pricing files do not indicate Medicare coverage of the drug. 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/FI processing your claim will make these determinations.
In addition, your carrier or FI is required to accomplish the following:
- Use the April 2005 ASP and NOC drug pricing files to pay for Medicare Part B drugs effective April 1, 2005. This file shall be used for dates of service from April 1, 2005 through June 30, 2005;
- Determine for any drug or biological not listed in the ASP or NOC drug pricing files, the payment allowance limits in accordance with the policies described in transmittal CR 3539, dated October 29, 2004, (see http://www.cms.hhs.gov/manuals/pm_trans/R348CP.pdf), and CR3232, dated December 16, 2004, (see http://www.cms.hhs.gov/manuals/pm_trans/R397CP.pdf). FIs should seek payment allowances from their local carrier;
- Use the new January 2005 ASP drug pricing file for (1) those claims where the carriers/FIs are asked to retroactively adjust claims processed with the original January 2005 file and (2) those claims with dates of service on or after January 1, 2005 and before April 1, 2005 that are processed after April 4, 2005. Your carrier or FI shall not search and adjust claims that have already been processed unless brought to their attention;
- Overlay the old January 2005 file with the new January 2005 file; and
- For any drug or biological for which they (your carrier or FI) calculate a payment allowance limit,
forward to CMS the following:
- The drug name,
- Dosage,
- Payment allowance limit, and
- National Drug Code (if available).
Note: The ASP and NOC drug pricing files will contain the 106 percent ASP, 106 percent WAC or WAC based payment allowance limits; therefore, no additional payment calculation is required by your carrier or FI. The payment limits for the blood clotting factor codes includes the $0.14 per I.U. furnishing fee.
Additional Information
The new January 2005 and April 2005 ASP and NOC Pricing Files are available from the following CMS Web site on or after March 17, 2005: http://www.cms.hhs.gov/providers/drugs/asp.asp
You can find more information about the April 2005 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing File, Effective April 1, 2005, and New January 2005 Quarterly ASP File at: http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
From that Web page, look for CR 3667 in the CR NUM column on the right, and click on the file for that CR.
Billing for Implantable Automatic Defibrillators for Beneficiaries in a Medicare Advantage (MA) Plan and Use of the QR Modifier to Identify Patient Registry Participation
Provider Types AffectedAll Medicare providers billing either a Medicare carrier or Fiscal Intermediary (FI) for Implantable Automatic Defibrillators for Medicare beneficiaries who are members of Medicare Advantage plans
Provider Action Needed
STOP – Impact to You
Be aware that CMS is expanding the set of medical indications for the use of implantable automatic defibrillators and this instruction discusses the impact of this change for beneficiaries who are members of an MA plan and receive these services.
CAUTION – What You Need to Know
Effective January 27, 2005, CMS is expanding national coverage for implantable automatic defibrillators by including the following new indications:
- Patients with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI), New York Heart Association (NYHA) Class II and III heart failure, and measured left ventricular ejection fraction (LVEF) < 35%;
- Patients with nonischemic dilated cardiomyopathy (NIDCM) > 9 months, NYHA Class II and III heart failure, and measured LVEF < 35%;
- Patients who meet all current CMS coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure;
- Patients with NIDCM > 3 months, NYHA Class II or III heart failure, and measured LVEF < 35%.
(See Note below)
GO – What You Need to Do
Make sure that your billing staffs are aware of these new indications and also the basis for billing Medicare.
Note: For beneficiaries under an MA plan, payment for defibrillator use effective January 27, 2005, is different for these new indications than it is for previously covered indications. When the beneficiary is under an MA plan, defibrillator use for these new indications is not part of the capitated rates and is to be paid Fee-For Service (FFS). However, payment for previously covered indications for defibrillators implanted in these beneficiaries will be part of the MA capitated rates
and is not to be paid FFS. In addition, data must be collected and reported through an approved data collection mechanism for beneficiaries that receive an implantable automatic defib rillator for the primary prevention (as opposed to secondary prevention) of sudden cardiac death. The above indications are considered primary prevention indications. Additional information regarding the ICD Abstraction Tool is available through a previously issued Special Edition MedLearn Article (SE0517) which is available at:
http://www.cms.hhs.gov/MedlearnMattersArticles/downloads/SE0517.pdf
Background
The Implantable Automatic Defibrillator, consisting of a pulse generator and electrodes for sensing and defibrillating, is an electronic device designed to detect and treat life-threatening tachyarrhythmias. Medicare pays for the use of these defibrillators for only certain clinical indications.
Here is a synopsis of the history of indications and payment policies (indicating the effective dates) for implantable defibrillators, leading up to Change Request (CR) 3604:
Indications
- July 1, 1991
Documented episode of cardiac arrest due to Ventricular Fibrillation (VF), not due to a transient or reversible cause - July 1, 1999
Documented sustained Ventricular Tachyarrhythmia (VT), either spontaneous or induced by an Electrophysiology (EP) study, not associated with an acute Myocardial Infarction (MI) and not due to a transient or reversible cause
Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy
- October 1, 2003
Coverage was expanded to include coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction < 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 4 weeks prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI).
Payment Policies
- October 1, 2003 (CRs 2880 & 2992)
For covered defibrillator claims made on behalf of MA (formerly known as M+C) beneficiaries, payment for the expanded coverage (above) would be made on a FFS basis until Medicare capitation rates to MA organizations were adjusted to account for expanded coverage.
Also at this time, system changes were implemented to enable the automatic processing and payment of covered defibrillator claims on an FFS basis when the beneficiary was under an MA plan and the claims included either a KZ modifier attached to the defibrillator procedure codes when billing a carrier or a condition code of 78 when billing a fiscal intermediary.
- January 1, 2005 (CR 3301)
Because MA rates have been appropriately adjusted to account for the defibrillator coverage described in CRs 2880 and 2992, covered services for the indications in these CRs will no longer be paid FFS when the beneficiary is under an MA plan.
Now in CR 3604, Medicare announces expanded coverage for implantable defibrillators for additional indications, effective January 27, 2005. These indications are:
- Patients with ischemic dilated cardiomyopathy (IDCM), documented prior myocardial infarction (MI), New York Heart Association (NYHA) Class II and III heart failure, and measured left ventricular ejection fraction (LVEF) < 35%;
- Patients with nonischemic dilated cardiomyopathy (NIDCM) > 9 months, NYHA Class II and III heart failure, and measured LVEF < 35%;
- Patients who meet all current CMS coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure;
- Patients with NIDCM > 3 months, NYHA Class II or III heart failure, and measured LVEF < 35%.
Please note this additional information:
- Since this new coverage exceeds the significant cost threshold for managed care organizations, services related to the newly covered indications will be paid only on a fee-for-service basis for patients enrolled in a managed care plan. To reiterate, for these new indications, Medicare will pay for covered defibrillators on an FFS basis for claims for beneficiaries under MA plans through December 31, 2005. (Coverage guidelines can be found in the National Coverage Determination Manual (NCDM), Section 20.4.). As a reminder, remember that MA plan beneficiaries are responsible for paying applicable coinsurance, but are not responsible for paying Part A or Part B deductibles (so you should assume that the Part A or Part B deductible has been met). To indicate that the beneficiary is under an MA plan and the services provided are for one of the new indications, providers are to include a KZ modifier for carrier claims and a condition code of 78 for fiscal intermediary claims until the MA capitated rates are adjusted.
- Payment for previously covered indications for defibrillator use, i.e., those indications approved prior to January 27, 2005, will be part of the MA capitated rates and are not to be paid on an FFS basis for beneficiaries under an MA plan.
- Except for reimbursing for the use of the defibrillators for the new indications, the processing of defibrillator claims for non-MA beneficiaries remains unchanged.
- For indications effective after January 27, 2005, patients must not have:
- Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm;
- Had a coronary artery bypass graft (CABG) or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past 3 months;
- Had an acute MI within the past 40 days;
- Clinical symptoms or findings that would make them a candidate for coronary revascularization; or
- Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.
- All patients considered for implantation of a defibrillator must be able to give informed consent.
- Myocardial infarctions must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction.
- Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography.
- Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the medical record.
You should also be aware that Medicare is requiring that patients receiving a defibrillator for the new indications (or for any other indication that is for the primary prevention of sudden cardiac arrest [no history of a previous cardiac arrest]) be enrolled in either a Food and Drug Administration-approved Category B Investigational Device Exemption (IDE) clinical trial, a trial under the Centers for Medicare & Medicaid Services Clinical Trial Policy, or a qualifying data collection system including approved clinical trials and registries to ensure the safety and quality of care.
Initially, CMS will maintain an implantable automatic defibrillator registry using a mechanism that Medicare participating hospitals already use to submit quality data to the Quality Improvement Organizations (QIOs). Hospital staff will fill out the data collection form (supplied by CMS) using the ICD Abstraction Tool and transmit it via QNet (Quality Network Exchange) to the QIO. Iowa Foundation for Medical Care (IFMC) will collect and maintain registry data and the QIOs will be able to ensure the quality of the data by sampling charts. Additional information regarding the ICD Abstraction Tool is available through a previously issued Special Edition MedLearn Article (SE0517), which is available at: http:/www.cms.hhs.gov/medlearn/matters/mmarticles/2005/SE0517.pdf
Additional data collection systems (trials or registries) addressing at a minimum the hypotheses specified in this decision 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;
- Certification that investigators have not been disqualified.
For purposes of this coverage decision, CMS will determine whether specific registries or clinical
trials meet these criteria.
Also, remember that the QR modifier was created for use on Part B claims to identify protocol covered services. The appropriate use of the QR modifier, in defibrillator claims, is to identify patients whose data is being submitted to a registry and to document meeting the coverage requirement for devices implanted for primary prevention of sudden cardiac arrest. Providers should only append the QR modifier on claims submitted on or after April 1, 2005. This modifier is not required when ICD-9-CM codes 427.1 ventricular tachycardia; 427.41 ventricular fibrillation; 427.42 ventricular flutter; 427.5 cardiac arrest; 427.9 cardiac dysrhythmia, unspecified appear on the claim, as these codes identify a patient receiving the device as secondary, not primary prevention, of sudden cardiac arrest.
On the other hand, if none of the above ICD-9 diagnosis codes applies to the device implant, patient data should be submitted to a registry and the QR modifier is required for claims submitted on or after April 1, 2005.
One final note:
- Providers billing Medicare Fiscal Intermediaries (FIs) should:
- Use the following G codes (payable under OPPS effective October 1, 2003): G0297, G0298,
G0299, and G0300.
Note: These G codes are not payable under the Medicare Physician Fee Schedule and, therefore, should not be billed to Medicare carriers. - Use the following ICD-9-CM procedure code on 11X type of bills: 37.94
- Providers billing carriers should use procedure code 33249.
Additional Information
You can find more information about Billing for Implantable Automatic Defibrillators for Beneficiaries in an MA Plan by going to: http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
From that Web page, look for CR 3604 in the CR NUM column on the right, and click on the file for that CR.
Finally, if you have any questions, please contact your carrier/intermediary at their toll-free number, which may be found at: http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
Surgical Wound Catheter for Post-Operative Pain Control
This type of catheter provides a continuous infusion of a local anesthetic directly into an intraoperative site for postoperative pain management. These catheters are being utilized in a wide variety of surgeries. No existing codes apply to this service; and CPT codes such as 11981 (insertion, non-biodegradable drug delivery implant) or codes from the series 64400-64449 (introduction/injection of anesthetic agents by single injection or continuous infusion for diagnostic or therapeutic services) cannot be used for this service. In particular, CPT code 64449 requires positioning of a catheter in order to block the entire lumbar plexus (i.e. including all the nerves formed in it). Likewise, CPT code 64448 for a continuous infusion by catheter of an anesthetic agent onto the femoral nerve requires specifically locating this nerve and placing the catheter into the sheath of the nerve. In both of these examples, the work in these procedures exceeds the placement of a pain catheter in an operative/incision site.
Please note that leaving a catheter behind in the operative field is considered a component of the surgical procedure and not separately payable by Medicare. It is important to also note that the control of pain is generally included in the global surgical package as part of post-operative care. Also, anesthesia and analgesia services provided by the operating surgeon are included in the Medicare payment for the surgical procedure and are not separately billable.
The publication of this article consolidates the approach to this subject matter across the CIGNA Government Services Part B jurisdiction and supersedes all previous statements and individual coverage determinations.
Hospice Pre-Election Evaluation and Counseling Services
Note: This article was revised on March 25, 2005, to emphasize that the medical director referenced in this article must be an employee of the hospice agency.
Provider Types Affected
Hospices, their medical directors, and physician employees
Provider Action Needed
STOP – Impact to You
Section 512 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) provides for a one-time payment to a hospice for pre-election evaluation and counseling services furnished by a physician who is either a medical director of or an employee of the hospice agency. HCPCS code G0337 will be used for these services and the payments for these services will not be included in the hospice payment cap.
CAUTION – What You Need to Know
Effective with services provided on or after January 1, 2005, Medicare systems will pay for hospice pre-election evaluation and counseling services furnished by the hospice-employed medical director or physician employee no more than one time only per beneficiary. Payment will be made on behalf of a beneficiary who is terminally ill (prognosis of six months or less if the disease runs its normal course), has not made a hospice election, and has not previously received hospice pre-election evaluation and counseling services.
GO – What You Need to Do
To ensure accurate claims processing, please review the information included here and stay current with instructions for hospice pre-election evaluation and counseling services. (The FY 2005 national payment amount for this service will be $54.57; future changes in the rate will be identified in the Physician Fee Schedules.)
Background
Effective January 1, 2005, Section 512 of the MMA amends Section 1812(a)(1)(5), 1814(i) and 1816(dd) of the Act to provide for a one-time payment to a hospice for evaluation and counseling services furnished by a physician who is either the medical director of or an employee of the hospice agency.
To be eligible to receive this service, a beneficiary must:
- Be determined to have terminal illness (which is defined as having a prognosis of six months or less if the disease or illness runs its normal course);
- Not have made a hospice election; and
- Not have previously received the pre-election evaluation and counseling services.
Services under this benefit are comprised of:
Evaluation of the patient’s need for pain and symptom management;
- Counseling regarding hospice and other care options; and may include
- Advice regarding advanced care planning.
The above noted services are currently available through other Medicare benefits. Therefore, this service may not be reasonable and necessary for all individuals. However, if a beneficiary or the beneficiary’s physician deem it necessary to seek the expertise of the medical director of the hospice agency or physician employee of the hospice agency, this benefit is available to assure that a beneficiary’s end-of-life options for care and pain management are addressed.
Please note that the evaluation and counseling service may not be initiated by the hospice (that is, the entity receiving payment for the service).
Payments by hospice agencies to physicians or others in a position to refer patients for services furnished under this provision may implicate the Federal anti-kickback statute.
If the beneficiary’s physician is also the medical director of a hospice, employed by a hospice, or possesses expertise in the provision of palliative or hospice care, that physician:
- Already possesses the expertise necessary to furnish end-of-life services; and
- Will have received payment for these services through the use of evaluation and management (E&M) codes.
Documentation
Appropriate documentation guidelines should be followed whether the beneficiary or the beneficiary’s
physician initiates the request for the evaluation and counseling service.
If the beneficiary’s physician initiates the request, which must be in writing, then:
- Determination of the terminal diagnosis should be included; however,
- Certification of the terminal diagnosis is not required, since this provision is not a prerequisite or part of the hospice benefit.
The hospice medical director or physician employee would be expected to provide a written note on the patient’s medical chart and maintain a written record of this service.
If the beneficiary initiates the request for the service, the hospice medical director or physician employee should:
- Maintain a written record of the service; and
- With the beneficiary’s permission, communicate with the beneficiary’s physician to the extent necessary to ensure continuity of care.
Payment
Section 512 of the MMA specifies that the payment will be made to the hospice for services provided by the hospice medical director or physician employed by the hospice. The provision of these services may not be delegated to any other hospice personnel (such as nurse practitioners, registered nurses, social workers, or others) and may not be furnished by a physician under contract with the hospice. Payment to the hospice agency for the provision of this evaluation and counseling service is made using HCPCS code G0337. The national payment amount for this service for FY 2005 will be $54.57.
Code G0337 will be paid only when billed by the hospice agency to its Medicare intermediary. Claim line items with G0337 submitted to a Medicare carrier will be denied. The hospice should submit such claims to its intermediary using type of bill 81x or 82x with the G0337 code and a revenue code of 0657 as the only revenue code on the claim.
Future changes in the rate will be identified in the Physician Fee Schedule.
The payment for these services is not included in the hospice payment cap, as the Evaluation and Counseling provision is not a service within the hospice benefit.
Additional Information
The official instructions issued to the intermediary regarding this change can be found at:
http://www.cms.hhs.gov/manuals/transmittals/comm_date_dsc.asp
On the above page, scroll down while referring to the CR NUM column on the right to find the links for CR3585. Click on the links to open and view the files for those CRs.
The two issuances of CR3585 include the actual revised sections of the Medicare Claims Processing and Medicare Benefit Policy Manuals resulting from this change.
If you have questions regarding this issue, please contact your fiscal intermediary at their toll free number, which may be found at: http://www.cms.hhs.gov/MedlearnProducts/downloads/CallCenterTollNumDirectory.pdf
Anti-Cancer Chemotherapy for Colorectal Cancer
Provider Types Affected
Providers and suppliers billing Medicare carriers, including Durable Medical Equipment Regional Carriers (DMERCs), and fiscal intermediaries (FIs) for anti-cancer chemotherapy
Provider Action Needed
This article is based on information contained in Change Request (CR) 3742, which states that the Centers for Medicare & Medicaid Services (CMS) will cover the off-label use of Oxaliplatin (Eloxatin™), Irinotecan (Camptosar®), Cetuximab (Erbitux™), or Bevacizumab (Avastin™) in clinical trials identified by CMS and sponsored by the National Cancer Institute (NCI).
This national coverage decision does not:
- Modify existing requirements for coverage of these and other anti-cancer chemotherapeutic agents for FDA-approved indications or for off-label indications listed in an approved compendium; or
- Change existing coverage for any off-label uses of these drugs provided outside the clinical trials identified.
Medicare carriers, DMERCs, and intermediaries will continue to make local coverage determinations for medically accepted uses of off-label indications based on guidance provided by the Secretary of the Department of Health and Human Services (DHHS).
Background
On January 28, 2005, CMS announced a National Coverage Determination (NCD) covering the off-label use of certain colorectal anti-cancer drugs in identified clinical trials of colorectal cancer and other cancer types. These clinical trials study the use of one or more off-label uses of these four drugs in colorectal and other cancer types.
