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March 4, 2008 Part B Medicare Bulletin

Posted March 4, 2008

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2007 Update of HCPCS Codes and Payments for Ambulatory Surgical Centers (ASCs)

Note: This article was revised on January 24, 2008, to add a reference to SE0742. SE0742 announced that CMS was implementing significant revisions to the payment system for ASC services beginning with services rendered on or after January 1, 2008. SE0742 may be found at http://www.cms.hhs.gov/MLNMattersArticles/downloads/se0742.pdf on the CMS Web site. All other information remains the same.

Do you have your NPI? National Provider Identifiers (NPIs) will be required on claims sent on or after May 23, 2007. Every health care provider needs to get an NPI. Learn more about the NPI and how to apply for an NPI by visiting http://www.cms.hhs.gov/NationalProvIdentStand/ on the CMS Web site.

Provider Types Affected
Ambulatory surgical centers (ASCs) submitting claims to Medicare carriers or fiscal intermediaries (FIs) for ASC services provided to Medicare beneficiaries.

Impact on Providers
This article is based on Change Request (CR) 5211, which updates the 2007 HCPCS codes and ASC payment rates, effective for services furnished on or after January 1, 2007.

Background
Section 5103 of the Deficit Reduction Act of 2005 (DRA) limits ASC payments to:

Also, §1833(i)(1) of the Social Security Act requires that the list of payable ASC procedures be updated as least every two years.

CR5211, from which this article is taken, implements the required biennial ASC update, which includes changes made by the American Medical Association for the CY 2007 Common Procedural Terminology (CPT). These changes include replacing the ASC 2-digit payment group code designation next to the ASC-approved Healthcare Common Procedure Coding System (HCPCS) codes with a “yy” designation for these codes, which will be defined as “the procedure is approved to be performed in an ambulatory surgical center.”

CR5211 also revises the manner in which ASC payment groups are defined. The number of ASC payment groups that carriers and fiscal intermediaries (FI) currently use to identify ASC payment amounts for individual HCPCS codes is being expanded in order to accommodate the new payment amounts that will be assigned to certain ASC services in Calendar Year (CY) 2007 under the DRA requirement. The ASC payment groups will now be called ASC PRICER groups

The additional ASC PRICER groups reflect the DRA-driven payment amounts, which will be included in the ASC PRICER files that carriers, and certain FIs, use to process ASC facility claims.

And lastly, CR5211 includes payment file retrieval instructions that your carriers and FIs will use to access the final payment files on, or after, the specified retrieval date provided in CMS’s notification.

You should be aware that final ASC payment rates are established after publication of the OPPS final rule and the code change update will be published as part of the OPPS final rule in the Federal Register. This publication usually occurs in late October. Shortly after publication, you can reach this rule through a link at http://www.cms.hhs.gov/center/asc.asp on the CMS Web site.

Also note that your carriers and FIs will continue to use the wage index values contained in Transmittal 51, dated February 4, 2004, to calculate payment amounts for all type of service F Healthcare Common Procedural Coding System (HCPCS) codes until further notice. This transmittal is available at http://www.cms.hhs.gov/Transmittals/downloads/R51OTN.pdf on the CMS site.

Additional Information
For complete details, please see CR 5211, the official instruction issued to your carrier/intermediary regarding this change, located at http://www.cms.hhs.gov/Transmittals/downloads/R1134CP.pdf on the CMS Web site. The “2007 ASC Approved HCPCS Codes and Payment Rates” Changes are available at http://www.cms.hhs.gov/ASCPayment/01_Overview.asp on the CMS site.

If you have any questions, please contact your carrier at their toll-free number, which may be found at
MLN Matters Number: MM5211 Related Change Request Number: 5211
http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.

Flu Shot Reminder
As a respected source of health care information, patients trust their doctors’ recommendations. If you have Medicare patients who haven’t yet received their flu shot, help protect them by recommending an annual influenza and a one time pneumococcal vaccination. Medicare provides coverage for flu and pneumococcal vaccines and their administration. And don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot. Remember —Influenza vaccination is a covered Part B benefit. Note that influenza vaccine is NOT a Part D covered drug. For more information about Medicare’s coverage of adult immunizations and educational resources, go to CMS’s Web site:
http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0667.pdf.

 

Additional Information on Reporting a National Provider Identifier (NPI) for Ordering/Referring and Attending/Operating/Other/Service facility for Medicare Claims

News Flash ― An additional election period for the Competitive Acquisition Program (CAP) for Medicare Part B drugs will start on January 15 and run through February 15, 2008, to give physicians a chance to take advantage of new changes to the program that began on January 1, 2008. The CAP is a voluntary program that provides an alternative to ASP for physicians to obtain certain Part B drugs. More information about the CAP is available at http://www.cms.hhs.gov/CompetitiveAcquisforBios/01_overview.asp on the CMS Web site.

Provider Types Affected
Physicians, providers, and suppliers who bill Medicare contractors (carriers, fiscal intermediaries (FI), Medicare Administrative Contractors (A/B MAC), or Durable Medical Equipment Medicare Administrative Contractors (DME MAC)) for services or items furnished to Medicare beneficiaries.

Provider Action Needed

STOP – Impact to You
Effective with claims received on or after May 23, 2008, Medicare will not pay for referred or ordered services or items; unless the fields for the name and NPI of the ordering, referring and attending, operating, other, or service facility providers are completed on the claims.

CAUTION – What You Need to Know
CR 5890, from which this article is taken, provides that it is the claim/bill submitter‘s responsibility to obtain the ordering, referring and attending, operating, other, service facility providers, or purchased service providers NPIs for claims. Further, it requires that the provider or supplier who is furnishing the services or items, after unsuccessfully attempting to obtain the NPI from these providers; report their own name and NPI in the ordering/referring/attending/operating/other/service facility provider/purchased service provider fields of the claims.

GO – What You Need to Do
Make sure that your billing staffs are aware of this requirement to place the “furnishing” provider or supplier’s name and NPI in the appropriate fields and to use your name and NPI if those of the ordering/referring and attending/operating/other/service facility provider/purchased service providers are not obtainable.

Background
The Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandate the adoption of a standard unique health identifier for each health care provider. The National Provider Identifier (NPI) final rule (45 CFR Part 162, CMS-045-F), published on January 23, 2004, established the NPI as this standard; and mandates that all entities covered under HIPAA (including health care providers) comply with the requirements of this NPI final rule.

Medicare previously required a unique physician identification number (UPIN) be reported on claims for any ordering, referring/attending, operating, other, and service facility providers (i.e., or for any provider that is not a billing, pay-to, or rendering provider). Further, in accordance with the NPI final rule; effective May 23, 2008, when reported on a claim, the identifier for such a provider must be an NPI, regardless of whether the provider is a covered entity, or participates in the Medicare program. Therefore, Medicare will not pay for referred or ordered services, or items, unless the name and NPI number of the ordering, referring and attending, operating, other, or service facility provider are on the claim.

Note: Physicians (MD and DO) and the following non physician practitioners: 1) nurse practitioners (NP); 2) clinical nurse specialist (CNS); 3) physician assistants (PA); 4) and certified nurse midwives (CNM) are the only types of providers eligible to refer/order services or items for beneficiaries.

You should be aware that it is the claim/bill submitter‘s responsibility to obtain the ordering, referring and attending, operating, other, service facility providers, or purchased service providers’ NPIs on the claim. If these providers do not directly furnish their NPIs to the billing provider at the time of the order, the billing provider must contact them to obtain their NPIs prior to delivery of the services or items.

If, after several unsuccessful attempts to obtain the NPI from the ordering, referring, attending, operating, other, service facility provider, or purchased service provider; CR 5890, from which this article is taken, requires that (effective May 23, 2008) the provider or supplier who is furnishing the services or items report their own name and NPI in the claim’s ordering/referring/attending/operating/other/service facility provider/purchased service provider fields.

Additional Information
You can find more information about reporting an NPI for ordering, referring and attending, operating, other, service facility providers for Medicare Claims by going to CR 5890, located at http://www.cms.hhs.gov/Transmittals/downloads/R235PI.pdf on the Centers for Medicare & Medicaid Services (CMS) Web site.

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

News Flash ― It’s Not Too Late to Get the Flu Shot. We are in the midst of flu season and a flu vaccine is still the best way to prevent infection and the complications associated with the flu. But re-vaccination is necessary each year because flu viruses change each year. Please encourage your Medicare patients who haven’t already done so to get their annual flu shot. And don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot— Not the Flu!

Remember — Influenza vaccination is a covered Part B benefit. Note that influenza vaccine is NOT a Part D covered drug. Health care professionals and their staff can learn more about Medicare’s coverage of adult immunizations and related provider education resources, by reviewing Special Edition MLN Matters article SE0748 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0748.pdf on the CMS Web site.

 

Ambulatory Surgical Center (ASC) Claims Processing Manual Clarification

Note: This article was revised on January 24, 2008, to add a reference to SE0742. SE0742 announced that CMS was implementing significant revisions to the payment system for ASC services beginning with services rendered on or after January 1, 2008. SE0742 may be found at http://www.cms.hhs.gov/MLNMattersArticles/downloads/se0742.pdf on the CMS Web site. All other information remains the same.

Do you have your NPI? National Provider Identifiers (NPIs) will be required on claims sent on or after May 23, 2007. Every health care provider needs to get an NPI. Learn more about the NPI and how to apply for an NPI by visiting http://www.cms.hhs.gov/NationalProvIdentStand/ on the CMS web site.

Provider Types Affected
Providers and suppliers of ambulatory surgical center (ASC) services

Provider Action Needed
This article is for informational purposes. CR5026 revises the Medicare Claims Processing Manual, Chapter 14 (Ambulatory Surgical Centers), Sections 10.3 (Services Furnished in ASCs Which Are Not ASC Facility Services) and 10.4 (Coverage of Services in ASCs Which Are Not ASC Facility Services) to clarify policy regarding the provision, coverage, and payment of services furnished in an ASC.

Background
Medicare conventionally reimburses ASCs in the form of a single payment that includes all “facility services” that the ASC furnishes in connection with a covered procedure. However, an ASC (perhaps as part of a medical complex that may include other entities, such as an independent laboratory, supplier of durable medical equipment, or a physician's office) may also furnish a number of covered items and services that are not considered facility services.

Be aware that such entities, which are separate from the ASC, are covered separately under Part B. Further, in general, the items or services that these entities provide are not considered ASC services, and are therefore not included in the ASC payment, but are rather covered and paid for under the applicable Part B provisions.

Examples of such services include:

More details about each of these services are shown in Table 1, below.

Table 1 - Examples of Services Not Included in the ASC Facility Rate

Items or Services Who Receives Payment Submit Bills To

Physicians' services Physicians who perform covered services ASCs receive separate payment under Part B. Such services include:

  • Anesthesiologists administering or supervising the administration of anesthesia to ASC patients and the patients’ recovery from the anesthesia;
  • Routine pre- or post-operative services, such as office visits, consultations, diagnostic tests, suture removal, dressing changes, and other services which are usually included in the physician fee for a given surgical procedure.
Physician Carrier
Non-implantable durable medical equipment (DMER) to ASC patients for in-home use
ASCs who sell, lease, or rent items of DME to patients, are treated as DME suppliers. All of the ordinary DME-applicable rules and conditions apply to the ASC, including obtaining a supplier number and billing the DMERC as required. 		Supplier
An ASC can be a supplier of DME if it has a DME supplier number from the National Supplier Clearinghouse. 		DMERC
Implantable DME and accessories
ASCs who furnish implantable DME items to patients, bill the local carrier for the surgical procedure and the implantable device. 		ASC Carrier

Non-Implantable prosthetic devices
ASCs who furnish non-implantable prosthetic devices to patients are treated as suppliers, and all the ordinary DME-applicable rules and conditions apply to the ASC, including obtaining a supplier number and billing the DMERC as required.

Supplier
An ASC can be a supplier of non-implantable prosthetics if it has a supplier number fromt he National Supplier Clearinghouse. 		DMERC
Implantable prosthetic devices except intraocular lenses (IOLs and NTIOLs [new technology intraocular lenses]), and accessories
ASCs may bill and receive separate payment for prosthetic devices (other than intraocular lenses [IOLs]) that are implanted, inserted, or otherwise applied by surgical procedures on the ASC list of approved procedures. The ASC bills the local Carrier and receives payment according to the DMEPOS fee schedule.
An intraocular lens (IOL) inserted during or subsequent to cataract surgery in an ASC is included in the facility payment rate. ASCs may receive additional payment for approved NTIOLs that are furnished in an ASC during or subsequent to certain cataract procedures.		 ASC Carrier
Ambulance Services
ASCs who furnish ambulance services, may obtain approval as ambulance suppliers to bill covered ambulance services. 		Certified ambulance supplier Carrier
Leg, arm, back, and neck braces
These items of equipment are not included in the ASC facility payment amount, but are covered under Part B. ASCs who furnish these items to patients are treated as suppliers, and all the rules and conditions ordinarily applicable to suppliers, and all the rules and conditions ordinarily applicable to suppliers apply to the ASC, including obtaining a supplier number and billing the DMERC as required. 		Supplier DMERC
Artificial legs, arms, and eyes
These items of equipment are not included in the ASC facility payment rate, but are covered under Part B.
ASCs who furnish these items to patients are treated as suppliers, and all the rules and conditions ordinarily applicable to suppliers apply to the ASC, including obtaining a supplier number and billing the DMERC as required. 		Supplier DMERC

Services Furnished by an independent laboratory
Only very limited numbers and types of diagnostic tests are considered ASC Facility services and these are included in the ASC Facility payment rate.

Since coverage of diagnostic lab tests in facilities other than physicians’ offices, rural health clinics or hospitals is limited to facilities that meet the statutory definition of an independent laboratory, in most cases diagnostic tests performed directly by an ASC are not considered ASC facility services (in fact are usually not covered under Medicare).

ASC laboratories must be CLIA certified and will need to enroll with the carrier as a laboratory. Otherwise, the ASC makes arrangements with a covered laboratory or laboratories for laboratory services. If the ASC has a certified independent laboratory, the laboratory itself bills the carrier.

Certified lab. ASCs can receive lab certification and a CLIA number Carrier

Procedures NOT on the ASC list
Physicians bill the carrier for the procedures and any implantable prosthetics/DME, using the ASC as the place of service.

Physician Carrier

Additional Information
You can find more information about services not included in the ASC facility rate (and the coverage of such services) by reviewing CR5026, which is available at http://www.cms.hhs.gov/Transmittals/downloads/R975CP.pdf on the CMS Web site.

The revised Medicare Claims Processing Manual, Chapter 14 (Ambulatory Surgical Centers), Sections 10.3 (Services Furnished in ASCs Which Are Not ASC Facility Services) and 10.4 (Coverage of Services in ASCs Which Are Not ASC Facility Services) are attached to CR5026.

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

 

CERT Improper Fee-for-Service (FFS) Error Rates November 2007 Improper Medicare Fee for Service Payment Report Results

The Centers for Medicare & Medicaid Services (CMS) has published the November 2007 Improper Medicare Fee-for-Service Payments Reports. These findings are a result of the Comprehensive Error Rate Testing (CERT) Program and percentages are based on those CIGNA Government Services Medicare Part B claims and services randomly selected and used for sampling purposes.

CIGNA Government Services wishes to thank all Part B providers and their staffs who responded and sent copies of documentation in response to CERT records requests. We recognize it is an additional task to include with the ongoing medical and administrative demands of a practice. Your cooperation helped to decrease the paid claim error rate, and helped us to pay you correctly for services you rendered to Medicare beneficiaries.

The following CERT Error Rates were published in the November 2007 report:

Also published in the November 2007 report were the CMS goals for future CERT Error Rates:

Additional information and findings may be accessed through the CMS Web site at
http://www.cms.hhs.gov/CERT/CR/list.asp.

Again, we would like to thank the entire provider community and staff members for past and future efforts directly contributing to the CERT error rate reductions. We do recognize and appreciate your labors. Congratulations!

 

Clarification Regarding the Coordination of Benefits Agreement (COBA) Medigap Claim-based Crossover Process

Note: This article was revised on January 30, 2008, to show the correct implementation date (see above), which is February 1, 2008. All other information remains the same.

News Flash ― The Hospice Payment System Fact Sheet, which offers providers information about the Medicare hospice benefit, is now available from the Centers for Medicare & Medicaid Services Medicare Learning Network in downloadable format at
http://www.cms.hhs.gov/MLNProducts/downloads/hospice_pay_sys_fs.pdf on the CMS Web site.

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

Provider Action Needed

STOP – Impact to You
This article is based on Change Request (CR) 5837 which clarifies instructions regarding the Coordination of Benefits Agreement (COBA) Medigap claim-based crossover process.

CAUTION – What You Need to Know
CR 5837 provides formal confirmation of a recent Centers for Medicare & Medicaid Services (CMS) decision to not require Medicare Part B contractors (including Durable Medical Equipment Medicare Administrative Contractors (DME MACs) to update their internal insurer tables or files with each Medigap insurer’s newly assigned Coordination of Benefits Agreement (COBA) Medigap claim-based ID, as was previously prescribed in CR 5662. In addition, CR 5837 conveys clarifying provider billing requirements in relation to Medigap claim-based crossovers.

GO – What You Need to Do
See the Background and Additional Information Sections of this article for further details regarding these changes.

Background
Effective October 1, 2007, the CMS transferred responsibility for the mandatory Medigap crossover process (also known as the “Medicare claim-based crossover process”) to its Coordination of Benefits Contractor. With this change, Part B contractors, including A/B MACs and DME MACs:

In a directive issued on September 18, 2007, CMS communicated to Medicare Part B contractors (carriers, DME MACs, and A/B MACs) its decision that they are not required to update their internal insurer files or tables with the Coordination of Benefits Contractor (COBC)-assigned COBA Medigap claim-based identifiers (IDs). This is because, as discussed in Change Request (CR) 5601, the contractors’ front-end system now simply verifies that a Medigap claim-based crossover identifier on an incoming claim is syntactically correct (5 digits, beginning with a “5”). CMS’ Common Working File (CWF) system is now tasked with validation of the actual ID submitted on incoming claims.

The September 18, 2007, directive represented a departure from previous guidance communicated in CR5662 (see MLN Matters article, MM5662, at
http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5662.pdf on the CMS Web site), in which CMS provided for transitional updating of the contractors’ internal insurer files/tables prior to October 1, 2007, once the COBC had:

CMS also required Medicare contractors to post language on their provider Web sites stipulating that:

CR 5837 instructs Part B contractors (including A/B MACs and DME MACs) that they are not required to update their internal insurer files/tables following a Medigap insurer’s readiness to move into production with the COBC. This requirement formerly applied to situations where CMS expected that contractors update their internal insurer files/tables prior to October 1, 2007, in accordance with CR 5662 (Transmittal 283). These Part B contractors may retain their older Other Carrier Name and Address (OCNA) or N-key identifiers within their internal insurer files/tables for purposes of avoiding system issues or for the printing of post-hoc beneficiary-requested Medicare Summary Notices (MSNs). However, in accordance with CR 5601, at http://www.cms.hhs.gov/transmittals/downloads/R1242CP.pdf on the CMS Web site, contractors will have disabled the logic that they formerly used to tag claims for crossover to Medigap insurers effective prior to claims they received for processing on October 1, 2007.

Effective with CR 5837, all Part B contractors (including A/B MACs and DME MACs) will discontinue publication of their routine Medigap newsletters. These contractors may, however, at their discretion, publish one last edition of this newsletter if desired to include the provider education language that follows:

In accordance with the language modification to MSN message 35.3
—“A copy of this notice will not be forwarded to your Medigap insurer because the information submitted on the claim was incomplete or invalid. Please submit a copy of this notice to your Medigap insurer.”—which contractors made as part of Transmittal 1242, CR 5601, all Part B contractors, including A/B MACs, and DME MACs shall make available a Spanish translation of the modified MSN message, which shall read as follows: “No se enviará copia de esta notificación a su asegurador de Medigap debido a que la información estaba incompleta o era inválida.

Favor de someter una copia de esta notificación a su asegurador Medigap.”

All Part B contractors (including A/B MACs, and DME MACs) are to inform their associated billing providers that are exempted from billing their claims electronically under the Administrative Simplification Compliance Act (ASCA) that they should only be entering the newly assigned 5-byte COBA Medigap claim-based ID (range 55000 to 59999) with item 9-D of the CMS-1500 claim form for purposes of triggering a crossing over of the claim to a Medigap insurer.

All Part B contractors (including A/B MACs, and DME MACs) are also to provide a link on their provider Web sites (preferably under “Hot Topics”) to the recently published special edition MLN article (SE0743 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0743.pdf on the CMS Web site) that clarifies for providers the differences between:

Providers should note that the listing at http://www.cms.hhs.gov/COBAgreement/Downloads/Medigap%20Claim-based%20COBA%20IDs%20for%20Billing%20Purpose.pdf on the CMS COB Web site is:

Additional Information
The official instruction, CR 5837, was issued in two transmittals issued to your Medicare carrier, DME MAC, or A/B MAC. Those transmittals may be viewed at http://www.cms.hhs.gov/Transmittals/downloads/R1420CP.pdf and http://www.cms.hhs.gov/Transmittals/downloads/R135FM.pdf on the CMS Web site. These transmittals make revisions to the Medicare Claims Processing and Medicare Financial Management Manuals, respectively

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

News Flash ― It’s Not Too Late to Get the Flu Shot. We are in the midst of flu season and a flu vaccine is still the best way to prevent infection and the complications associated with the flu. But re-vaccination is necessary each year because flu viruses change each year. Please encourage your Medicare patients who haven’t already done so to get their annual flu shot. And don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot – Not the Flu! Remember - Influenza vaccination is a covered Part B benefit. Note that influenza vaccine is NOT a Part D covered drug. Health care professionals and their staff can learn more about Medicare’s coverage of adult immunizations and related provider education resources, by reviewing Special Edition MLN Matters article SE0748 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0748.pdf on the CMS Web site.

Individuals Authorized Access to CMS Computer Services — Provider Community (IACS-PC): THE SECOND IN A SERIES OF ARTICLES ON THE IACS

News Flash ― Test Your Medicare Claims Now! After you have submitted claims containing both National Provider Identifiers (NPIs) and legacy identifiers and those claims have been paid, Medicare urges you to send a small batch of claims now with only the NPI in the primary provider fields. If the results are positive, begin increasing the number of claims in the batch. (Reminder: For institutional claims, the primary provider fields are the Billing and Pay-to Provider fields. For professional claims, the primary provider fields are the Billing, Pay-to, and Rendering Provider fields. If the Pay-to Provider is the same as the Billing Provider, the Pay-to Provider does not need to be identified.)

Note: This article was revised on January 15, 2008, to add another question and answer to emphasize that potential users should only register once in IACS.

This article contains:

NOTE: For purposes of the IACS-PC, “Provider Organizations” include individual practitioners who will delegate IACS-PC work to staff as well as their staff using IACS-PC.

Provider Types Affected
Physicians, providers, and suppliers (collectively referred to as providers) who submit fee-for-service claims to Medicare contractors (carriers, fiscal intermediaries (FIs), Regional Home Health Intermediaries (RHHIs), and Medicare Administrative Contractors (A/B MACs)).

Special Note for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers. Do not register for IACS -PC at this time. DMEPOS suppliers may want to review the first MLN Matters article in this new series on IACS-PC, which can be found at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0747.pdf on the Centers for Medicare & Medicaid Services (CMS) Web site.

Provider Action Needed
Even though these new Internet applications are not yet available, CMS recommends that providers take the time now to set up their online account so they can access these applications as soon as they are available. The first step is for the provider and/or appropriate staff to register for access through a new CMS security system known as the Individuals Authorized Access to CMS Computer Services - Provider Community (IACS-PC).

What Providers Need to Know
In the near future, CMS will be announcing new online enterprise applications that will allow Medicare fee-for-service providers to access, update, and submit information over the Internet. CMS enterprise applications are those hosted and managed by CMS and do not include FI/Carrier/MAC Internet applications. Details of these provider applications will be announced as they become available.

Registering in IACS-PC
The provider community is the first in a series of IACS communities which are the front-door to protecting and allowing access to CMS enterprise applications. Communities are comprised of groups of users who provide a similar service to CMS and who need access to similar applications (ex. Providers need access to provider-related CMS applications). The next community which will become available in early 2008 is the FI/Carrier/MAC community. It will be comprised of users who work within Medicare contracting organizations (FI’s, Carriers and MACs). Since many IACS communities will be added in the future, the IACS community’s user instructions are generic to allow use by multiple communities. The rules and concepts across communities are very similar.

When given a choice in IACS to select your community, please select the “Provider Community.”
The first MLN Matters article in this series provided an overview of the IACS-PC registration process as well as registration instructions for Security Officials (SOs) and individual practitioners using IACS-PC personally. This article can be found at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0747.pdf on the CMS Web site.

Four Questions and Answers about the Provider Organization Registration Process

  1. How can I get registered in IACS-PC? Can I just figure it out by myself?
    We recommend that you use the reference guides as they contain detailed explanations of the role responsibilities, acceptable data formats and interpretations of error messages. To directly access IACS-PC, go to https://applications.cms.hhs.gov and then click on Enter CMS Applications Portal.
  2. I want to register as an SO. I do not have my organization’s IRS CP-575. What else can I send?
    In addition to the CP-575, SOs may also submit copies of other official IRS documentation. An official IRS document should have the following information:

Required:

Optional:

Examples of acceptable IRS documents include, but are not limited to:

All documents received must be legible.

  1. I will work for more than one provider, or serve in multiple roles in the same organization. Do I need to register in IACS separately for each organization or role?

No. Each user will receive only one IACS-PC User ID and password. If you will work for more than one provider, or have multiple roles in the same provider, register in IACS for one role. Once you receive approval and your user ID and password, you can add additional roles to your account.

Instructions for modifying your IACS profile will be released shortly. In the meantime, questions may be directed to the help desk as shown in the “Additional Help” section at the end of this article.

  1. My organization is too small to fill all these roles. What should I do?
    As few as two staff can be registered in IACS-PC for a provider organization to access CMS enterprise applications. The first person must register as a Security Official (SO), the second registers as a User Group Administrator (UGA). The UGA may access CMS applications as approved by the SO.

The Backup Security Official is an optional role. End users are only required for provider organizations with 10 or more IACS-PC users.

If you are an individual practitioner who will be using IACS-PC personally, please refer to the first MLN article which may be found at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0747.pdf on the CMS Web site.

Quick Reference Guides for Completing the Provider Organization Registration Process

IACS-PC Registration Approval Process

  1. Backup Security Official (BSO) Guide
    BSOs will request access to an organization using the BSO Registration Quick Reference Guide at
    http://www.cms.hhs.gov/MMAHelp/downloads/iacs_backup_security_official_registration_qrg_12_06_07.pdf on the CMS Web site.
  2. User Group Administrator (UGA) Guide
    UGAs are the first user type able to request access to CMS Web-based applications. Their task, during the registration process, is to create a provider or surrogate user group, or associate with an existing provider or surrogate user group. A provider user group is a group that can be created by a UGA within an existing provider organization.

Once the user group is created and approved by the SO/BSO, end users can then submit a request to register in IACS-PC and join that user group. The UGA will either approve or deny their request to join their user group. This is a way for users within an organization to form groups that align with business needs or any other logical grouping that is appropriate for that organization and ensure that the UGA appropriately approves each end user into their user group. The important thing to keep in mind is that the UGA will need to approve the end users in the user group for which s/he is responsible, so they should know everyone in their user group.

The UGA Registration Quick Reference Guide may be found at http://www.cms.hhs.gov/MMAHelp/downloads/iacs_user_group_administrator_registration_qrg_12_06_07.pdf on the CMS Web site.

Special note for UGAs of Surrogate User Groups
A surrogate user group is established by individuals or a company outside of the provider organization which performs Medicare work on behalf of the provider organization (a contractor for a provider organization, billing company, etc.). If you will be creating a surrogate user group, the UGA of the surrogate user group must be approved by the SO or BSO in the provider organization on whose behalf it performs work. For example: Surrogate Billing Company ABC will work on behalf of Provider Organization XYZ. Once the Provider Organization XYZ is approved in IACS-PC, the Surrogate Billing Company ABC can register in IACS-PC and request to create a surrogate user group under the Provider Organization XYZ. Once approved, the UGA of a surrogate user group is issued an IACS user ID that enables the UGA to associate with other provider organizations for which it performs work without registering again.

At this time, a new surrogate user group must be created for each provider organization with which a UGA wishes to associate. If a surrogate user group performs work on behalf of 3 different provider organizations, the UGA for the surrogate user group will need to make 3 different requests to create 3 different surrogate user groups, one for each provider with which the UGA needs to associate. If a provider organization does not appear in IACS-PC, they have not yet registered/been approved and you should contact them. You will not be able to associate with them until the provider appears in IACS-PC.

If the provider organization does appear in IACS-PC, each provider’s SO or BSO must approve the request to associate that surrogate user group with their organization. Remember, as a surrogate user group, you will only be able to associate with provider organizations after those respective provider organizations and SOs have been approved in IACS-PC.

In the future, CMS will explore options for simplifying this process for contractors which perform work on behalf of more than one provider organization and also to allow surrogate user groups to associate to Individual Practitioners within IACS-PC.

  1. An End User Registration Quick Reference Guide may be found at http://www.cms.hhs.gov/MMAHelp/downloads/iacs_end_user_registration_qrg_12_06_07.pdf on the CMS Web site.
  2. Approver Quick Reference Guide
    The Approver Quick Reference Guide provides step-by-step instructions that SOs, BSOs and UGAs will use to approve or deny user requests to register in IACS-PC. The Approver Quick Reference Guide can be found at http://www.cms.hhs.gov/MMAHelp/downloads/iacs_approver_qrg_12_07_07.pdf on the CMS Web site.

Next Steps in Accessing a CMS Enterprise Application
A third MLN article discussing the final steps in accessing CMS enterprise applications has been released on this issue, and may be found at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0754.pdf on the CMS Web site.

Additional Help
The CMS has established an External User Services (EUS) Help Desk to assist with your access to IACS-PC. The EUS Help Desk may be reached by E-mail at EUSSupport@cgi.com or by phone on 1.866.484.8049 or TTY/TDD on 1.866.523.4759.

In addition, you can find an informative reference chart outlining the steps for accessing CMS enterprise applications at http://www.cms.hhs.gov/MLNProducts/downloads/IACSchart.pdf on the CMS Web site.

News Flash ― It’s seasonal flu time again! If you have Medicare patients who haven’t yet received their flu shot, you can help them reduce their risk of contracting the seasonal flu and potential complications by recommending an annual influenza and a one-time pneumococcal vaccination. Medicare provides coverage for flu and pneumococcal vaccines and their administration. And don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot — Not the Flu! Remember — Influenza vaccination is a covered Part B benefit but the influenza vaccine is NOT a Part D covered drug. Health care professionals and their staff can learn more about Medicare’s coverage of adult immunizations and related provider education resources, by reviewing Special Edition MLN Matters article SE0748 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0748.pdf on the CMS Web site.

January 2008 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

News Flash ― It’s Not Too Late to Get the Flu Shot. We are in the midst of flu season and a flu vaccine is still the best way to prevent infection and the complications associated with the flu. But re-vaccination is necessary each year because flu viruses change each year. Please encourage your Medicare patients who haven’t already done so to get their annual flu shot. And don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot — Not the Flu! Remember — Influenza vaccination is a covered Part B benefit. Note that influenza vaccine is NOT a Part D covered drug. Health care professionals and their staff can learn more about Medicare’s coverage of adult immunizations and related provider education resources, by reviewing Special Edition MLN Matters article SE0748 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0748.pdf on the CMS Web site.”

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

What You Need to Know
CR 5852, from which this article is taken, instructs Medicare contractors to download and implement the January 2008 Average Sales Price (ASP) drug pricing file for Medicare Part B drugs; and if released by CMS, also the revised January 2007, April 2007, July 2007, October 2007, April 2006, July 2006, and October 2006 files.

Background
Section 303(c) of the Medicare Modernization Act of 2003 revised the payment methodology for Part B covered drugs and biologicals that are not paid on a cost or prospective payment basis. Beginning January 1, 2005, the vast majority of drugs and biologicals not paid on a cost or prospective payment basis are paid based on the average sales price (ASP) methodology, and pricing for compounded drugs has been performed by the local contractor.

Additionally, beginning in 2006, all end-stage renal disease (ESRD) drugs (that both independent and hospital-based ESRD facilities furnish), as well as specified covered outpatient drugs, and drugs and biologicals with pass-through status under the Outpatient Prospective Payment System (OPPS), are paid based on the ASP methodology.

The ASP methodology is based on quarterly data that drug manufacturers submit to the Centers for Medicare & Medicaid Services (CMS), which CMS then provides (quarterly) to Medicare contractors (carriers, DME MACs, FIs, A/B MACs, and/or RHHIs) through the ASP drug pricing files for Medicare Part B drugs.

As announced in late 2006, CMS has been working further to ensure that accurate and separate payment is made for single source drugs and biologicals as required by Section 1847A of the Social Security Act. As part of the effort to ensure compliance with this requirement, CMS has also reviewed how the terms “single source drug,” “multiple source drug,” and “biological product” have been operationalized in the context of payment under section 1847A.

For the purpose of identifying “single source drugs” and “biological products” subject to payment under section 1847A, CMS (and its contractors) will generally utilize a multi-step process that will consider:

  1. The FDA approval,
  2. Therapeutic equivalents as determined by the FDA, and
  3. The date of first sale in the United States.

The payment limit for the following will be based on the pricing information for products marketed or sold under the applicable FDA approval:

As appropriate, a unique HCPCS code will be assigned to facilitate separate payment. Separate payment may be operationalized through use of “not otherwise classified, (NOC)” HCPCS codes.

ASP Methodology
In general, 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% of the ASP. Beginning January 1, 2006, payment allowance limits are paid based on the ASP methodology for the following:

ESRD drugs (when separately billed by freestanding and hospital-based ESRD facilities), and

Summary of Exceptions to this General Rule

 

  1. Except for blood clotting factors, the payment allowance limits for blood and blood products (that are not paid on a prospective payment basis) 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% of the average wholesale price (AWP) as reflected in the published compendia; and will be updated on a quarterly basis. Blood and blood products furnished in the hospital outpatient department are paid under OPPS at the amount specified for the APC to which the product is assigned.

Note: For 2006, the blood clotting furnishing factor of $0.146 per I.U. is added to the payment amount for the blood clotting factor when the blood clotting factor is not included on the ASP file. For 2007, the blood clotting furnishing factor of $0.152 per I.U. is added to the payment amount for a new blood clotting factor when a new blood clotting factor is not included on the ASP file. For 2008, a separate fee of $0.158 per I.U. of blood clotting factor furnished is payable when separate payment for the blood clotting factor is made. The furnishing fee will be included in the payment amounts on the quarterly ASP pricing files.

  1. Payment allowance limits for infusion drugs furnished through a covered item of durable medical equipment (DME) on or after January 1, 2005, will continue to be 95% of the AWP reflected in the published compendia as of October 1, 2003, unless the drug is compounded or incident to a professional service. The payment allowance limits will not be updated in 2008.
    Similarly, payment allowance limits for infusion drugs furnished through a covered item of DME that were not listed in the published compendia as of October 1, 2003, (i.e., new drugs) are 95 percent (95%) of the first published AWP unless the drug is compounded or furnished incident to a professional service.
  2. The payment allowance limits for influenza, Pneumococcal and Hepatitis B vaccines are 95% of
    the AWP as reflected in the published compendia except, when administered in a hospital
    outpatient department, the vaccines are paid at reasonable cost.
  3. Except for new drugs and biologicals that are produced, or distributed, under a new drug application (or other application) approved by the Food and Drug Administration (FDA), the payment allowance limits for drugs and biologicals that are not included in the ASP Medicare Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing File, are based on the published wholesale acquisition cost (WAC) or invoice pricing (except under OPPS in which the payment allowance limit is 95% of the published AWP).

In determining the payment limit based on WAC, contractors will follow the methodology specified in the Medicare Claims Processing Manual, Chapter 17, Drugs and Biologicals, for calculating the AWP but will substitute WAC for AWP. The payment limit is 100% of the lesser of the lowest-priced brand or median generic WAC.

  1. The payment allowance limits for new drugs and biologicals that were first sold on or after January 1, 2005; and are: 1) Produced or distributed under a new drug application (or other new application) approved by the Food and Drug Administration, and 2) Not included in the ASP Medicare Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing File; are based on 106% of the WAC (or invoice pricing if the WAC is not published) except under OPPS in which the payment allowance limit is 95% of the published AWP.
  2. The payment allowance limits for radiopharmaceuticals are not subject to the ASP payment methodology. Contractors should determine payment limits for radiopharmaceuticals based on the methodology in place as of November 2003 in the case of radiopharmaceuticals furnished in other than the hospital outpatient department. Radiopharmaceuticals furnished in the hospital outpatient department are paid charges reduced to cost by the hospital’s overall cost to charge ratio.
  3. The payment methodology for drugs furnished incident to the filling or refilling of an implantable pump or reservoir is determined under the ASP methodology (as described above) unless the drug furnished incident to the filling or refilling of an implantable pump or reservoir is a compounded drug, then pricing is performed by the local contractor.
    Physicians (or a practitioner described in Section 1842(b) (18) (C)) may be paid for filling or refilling an implantable pump or reservoir when it is medically necessary that they perform the service. Contractors must find the use of the implantable pump or reservoir medically reasonable and necessary in order to allow payment for the professional service to fill or refill the implantable pump or reservoir and to allow payment for drugs furnished incident to the professional service.

If a physician (or other practitioner) is prescribing medication for a patient with an implantable pump, a nurse may refill the pump if the medication administered is:

On or after December 18, 2007, the January 2008 ASP file and ASP NOC files will be available for retrieval from the CMS ASP Web page. If CMS determines that revisions to the January 2007, April 2007, July 2007, October 2007, April 2006, July 2006 and October 2006 ASP payment files are necessary, the revised files will also be available for retrieval from the CMS Web page on or after December 18, 2007. The revised payment files will be applied to claims processed or reprocessed on or after this CR’s (5852) effective date.

Table 1 below displays the payment allowance limit revision dates, and the applicable dates of service.

Table 1
Payment Allowance Limit Revision Date Applicable Dates of Service

Payment Allowance Limit Revision Date Applicable Dates of Service
January 2008 January 1, 2008 through March 31, 2008
Revised January 2007* January 1, 2007 through March 31, 2007
Revisied April 2007* April 1, 2007 through June 30, 2007
Revised July 2007 * July 1, 2007 through September 30, 2007
Revised October 2007* October 1, 2007 through December 31, 2007
Revised April 2006* April 1, 2006 through June 30, 2006
Revised July 2006* July 1, 2006 through September 30, 2006
Revised October 2006* October 1, 2006 through December 31, 2006

*If made available by CMS

Note: The payment limits included in revised ASP and NOC payment files supersede the payment limits for these codes in any publication published prior to this document.

Final Notes: 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 local Medicare contractor processing the claim will make these determinations.

Contractors (at their discretion) may contact CMS to obtain payment limits for drugs and biologicals not included in the quarterly ASP or NOC files, or that CMS has not otherwise made available on its Web site. If the payment limit is available from CMS, contractors will substitute CMS-provided payment limits for pricing based on WAC or invoice pricing.

Contractors will not search for, and adjust, a claim that has already been processed unless you bring it to their attention.

Implementation
The implementation date is January 7, 2008.

Additional Information
For complete details, please see the official instruction (CR 5852) issued to your carriers, DME MACs, FIs, A/B MACs, and/or RHHIs regarding this change, by visiting http://www.cms.hhs.gov/Transmittals/downloads/R1406CP.pdf on the CMS Web site.

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

Mammography: Change Certification-Based Action from Return to Provider (RTP)/Return as Unprocessable to Denial

Note: This article was revised on January 15, 2008, to correct the RA reason code for carriers/B MACs for claims that contain a film mammography HCPCS code and the facility is certified for digital mammography only (page 4). The correct RA code is 171 and not B6 as previously stated. All other information remains unchanged.

News Flash ― A new preventive services brochure entitled Smoking and Tobacco-Use Cessation Counseling Services, ICN# 006767, is now available on the Centers for Medicare & Medicaid Services (CMS) Medicare Learning Network (MLN). This tri-fold brochure provides health care professionals with an overview of Medicare’s coverage of smoking cessation services. The brochure is available at
http://www.cms.hhs.gov/MLNproducts/downloads/smoking.pdf on the CMS Web site.

Provider Types Affected
Providers who bill Medicare fiscal intermediaries, carriers, and Part A/B Medicare Administrative Contractors (MACs) for mammography services

What You Need to Know
CR 5577, from which this article is taken, instructs FIs, carriers and A/B MACs to deny claims for mammography services (rather than returning them as unprocessable) if the appropriate Food and Drug Administration (FDA) certification status is not listed on the FDA-created, CMS-supplied, Mammography Quality Standard Act (MQSA) data file. You should make sure that your billing staffs list the FDA certification status as required.

Background
Depending on which contractor you bill, FIs and A/B MACs return to provider (RTP), and carriers or A//B MACs return as unprocessable, claims for mammography services when:

In order to ensure that the facility has a right to appeal an inappropriate denial based on the status of its FDA certification, CR 5577, from which this article is taken, instructs Medicare FIs, carriers and A/B MACs to deny all claims for screening or diagnostic mammography services (rather than return them to the provider, or return as unprocessable to the supplier), if the appropriate FDA certification status is not listed on the claim. Please note, however, that carriers/B MACs will continue to return the claim as unprocessable if the facility’s FDA-assigned certification number is missing from the claim.

The MQSA requires that all facilities providing mammography services meet national quality standards, and provides the specific standards for those qualified to perform screening and diagnostic mammograms and how they should be certified.

The FDA Center for Devices and Radiological Health is responsible for collecting certificate fees and surveying mammography facilities; and effective October 1, 1994, all facilities that provide screening and mammography services (except those in the Veterans Administration) must have an FDA-issued certificate to continue to operate.

In addition, Section 104 of the Benefits Improvement and Protection Act (BIPA) of 2000 provided new payment methodologies for both diagnostic and screening mammograms that use digital technology. Medicare pays for film mammography and digital mammography at different rates, and moreover, pays for a service only if the provider or supplier is certified by the Food and Drug Administration (FDA) to perform those types of mammograms for which payment is sought.

Medicare determines whether the mammography facility is certified to perform the mammography services billed by using data that the FDA sends to CMS on a weekly basis. This information indicates whether a mammography facility is certified to perform digital mammography.

To verify that the facility is certified by the FDA to perform mammography services, carriers/B MACs match the supplier’s (i.e., independent facility) mammography certification number submitted on the claim to the 6-digit FDA-assigned certification number appearing on the file for the billing facility (in item 32 of the Form CMS-1500 for paper claims, or in the 2400 loop (REF02 segment, where 01=EW segment) of the ASC X12 837 professional claim format, version 4010A1, for electronic claims). If the facility’s FDA-assigned 6-digit number is not on the claim, the carrier/B MAC will return the claim as unprocessable using remittance reason code 16 (Claim/service lacks information which is needed for adjudication) and remark code MA128 (Missing/incomplete/invalid FDA approval number).

Intermediaries/A MACs identify the facility using the provider number submitted on the claim and use the certification data contained on the MQSA file. In addition, both intermediaries/A MACs and carriers/B MACs look for the film indicator (designated by “1”) or the digital indicator (designated by “2”) on the MQSA file to verify the type of mammography (film and/or digital) that the facility is certified to perform.

Therefore, effective April 1, 2008:

Further, Medicare contractors will use the FDA certification data to verify that the billing facility is eligible to bill for the type of mammography service submitted on the claim.

They will deny the claim if the facility is not certified by the FDA to perform such service (if the HCPCS code on the claim, for either film or digital mammogram, does not match the type of certification indicated on the MQSA file).

In denying these claims because the facility is not certified by the FDA to perform either a screening or diagnostic mammography service, Medicare contractors will use:

Similarly, Medicare contractors will deny the claim if it contains a digital mammography HCPCS code and the facility is certified for film mammography only. In denying these claims because the facility is not certified to perform digital mammography, they will again use MSN message 16.2. In this instance:

Additional Information
You can find the official instruction, CR5577, issued to your carrier, FI, or A/B MAC by visiting http://www.cms.hhs.gov/Transmittals/downloads/R1387CP.pdf on the CMS Web site. Additionally, you can find the revised sections of the Medicare Claims Processing Manual, Chapter 18 (Preventive and Screening Services), Section 20.2 (HCPCS and Diagnosis Codes for Mammography Services) as an attachment to CR5577.

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

News Flash ― It’s seasonal flu time again! If you have Medicare patients who haven’t yet received their flu shot, you can help them reduce their risk of contracting the seasonal flu and potential complications by recommending an annual influenza and a one-time pneumococcal vaccination. Medicare provides coverage for flu and pneumococcal vaccines and their administration. And don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot — Not the Flu! Remember— Influenza vaccination is a covered Part B benefit but the influenza vaccine is NOT a Part D covered drug. Health care professionals and their staff can learn more about Medicare’s coverage of adult immunizations and related provider education resources, by reviewing Special Edition MLN Matters article SE0748 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0748.pdf on the CMS Web site.

 

Medicare Payment for Pre-administration-Related Services Associated with Intravenous Immune Globulin (IVIG) Administration—Payment Extended through CY 2008

News Flash ― Test Your Medicare Claims Now! After you have submitted claims containing both National Provider Identifiers (NPIs) and legacy identifiers and those claims have been paid, Medicare urges you to send a small batch of claims now with only the NPI in the primary provider fields. If the results are positive, begin increasing the number of claims in the batch. (Reminder: For institutional claims, the primary provider fields are the Billing and Pay-to Provider fields. For professional claims, the primary provider fields are the Billing, Pay-to, and Rendering Provider fields. If the Pay-to Provider is the same as the Billing Provider, the Pay-to Provider does not need to be identified.)

Provider Types Affected
Physicians or hospital outpatient facilities billing Medicare contractors (carriers, fiscal intermediaries (FIs), and/or A/B Medicare Administrative Contractors (A/B MACs)) for services related to the preadministration of Intravenous Immune Globulin (IVIG) for Medicare beneficiaries.
Provider Action Needed

STOP – Impact to You
In 2006 and 2007, Medicare made a separate payment to physicians and hospital outpatient departments for pre-administration-related services associated with administration of IVIG, Healthcare Common Procedure Coding System (HCPCS) code G0332.

CAUTION – What You Need to Know
CR5713, from which this article was taken, states that the Centers for Medicare & Medicaid Services (CMS) is extending the temporary IVIG pre-administration-related services payment to hospital outpatient departments and physicians that administer IVIG through calendar year (CY) 2008. This IVIG pre-administration service can only be billed by the physician or outpatient hospital providing the IVIG infusion once per patient per day of IVIG administration. For services on or after January 1, 2008, the service must be billed on the same claim form as the IVIG product (J1566, J1568, J1569, J1561 and/or J1572) and have the same date of service as the IVIG product and a drug administration service.

GO – What You Need to Do
Make certain that your billing staff is aware of these billing requirements.

Background
Under Section 1861(s) (1) and 1861(s) (2), Medicare Part B covers IVIG administered by physicians in physician offices and by hospital outpatient departments. More specifically, when you administer IVIG to a Medicare beneficiary in the physician office or hospital outpatient department, Medicare makes separate payments to the physician or hospital for both the IVIG product itself and for its administration via intravenous infusion.

This payment is for the additional pre-administration-related services required to locate and acquire adequate IVIG product during this current period where there may be potential market issues.
As a reminder, here are some important details that you should know:

Note: The definition for J1566 is changed effective January 1, 2008. The new definition is “Injection, immune globulin, intravenous, lyophilized (e.g., powder), NOS, 500MG.”

Additional Information
For complete details regarding this issue, please see the official instruction (CR5713) issued to your Medicare FI, carrier or A/B MAC. That instruction may be viewed by going to http://www.cms.hhs.gov/Transmittals/downloads/R1338CP.pdf on the CMS Web site.

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

You may also want to view CR 5635, which implemented HCPCS Coding Changes for Immune Globulin, effective for services on or after July 1, 2007. For the article related to this CR, please visit
http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5635.pdf on the CMS site.

News Flash ― It’s Not Too Late to Get the Flu Shot. We are in the midst of flu season and a flu vaccine is still the best way to prevent infection and the complications associated with the flu. But re-vaccination is necessary each year because flu viruses change each year. Please encourage your Medicare patients who haven’t already done so to get their annual flu shot. And don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot — Not the Flu! Remember — Influenza vaccination is a covered Part B benefit. Note that influenza vaccine is NOT a Part D covered drug. Health care professionals and their staff can learn more about Medicare’s coverage of adult immunizations and related provider education resources, by reviewing Special Edition MLN Matters article SE0748 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0748.pdf on the CMS Web site.”

Modification to the Model Medicare Redetermination Notice (for partly or fully unfavorable redeterminations)

News Flash ― It’s Not Too Late to Get the Flu Shot. We are in the midst of flu season and a flu vaccine is still the best way to prevent infection and the complications associated with the flu. But re-vaccination is necessary each year because flu viruses change each year. Please encourage your Medicare patients who haven’t already done so to get their annual flu shot. And don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot — Not the Flu! Remember — Influenza vaccination is a covered Part B benefit. Note that influenza vaccine is NOT a Part D covered drug. Health care professionals and their staff can learn more about Medicare’s coverage of adult immunizations and related provider education resources, by reviewing Special Edition MLN Matters article SE0748 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0748.pdf on the CMS Web site.

Provider Types Affected
All physicians, providers, and suppliers who bill Medicare contractors (carriers, fiscal intermediaries (FI), regional home health intermediaries (RHHI), Medicare Administrative Contractors (A/B MAC), or Durable Medical Equipment Medicare Administrative Contractors (DME MAC)) for services provided or supplied to Medicare beneficiaries.

What You Need to Know
CR 5836, from which this article is taken, modifies the Reconsideration Request Form that is included with the model Medicare Redetermination Notice (for partly or fully unfavorable redeterminations), to clarify the minimum set of elements on the form that you must complete in order for the request to be considered valid for reconsideration.

You should make sure that your billing staffs are aware that they must complete items 1, 2a, 6, 7, 11 & 12 on this Reconsideration Request Form.

Background
The Reconsideration Request Form modification that CR 5836 requires is necessary because the current Medicare manual instructions do not clearly identify all of the elements required for a reconsideration request to be considered valid in accordance with Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) Section 405.964(b).

The modification to the form is as follows:
“Directions: If you wish to appeal this decision, please fill out the required information below and mail this form to the address shown below. At a minimum, you must complete/include information for items 1, 2a, 6, 7, 11 & 12 but to help us serve you better, please include a copy of the redetermination notice with your request.” Those elements that, as a minimum, you must complete in the form are:

1. Name of Beneficiary
2a. Medicare Number
6. Item or service you wish to appeal
7. Date of the service (From and To dates)
11. Name of Person Appealing
12. Signature of Person Appealing/Date

Additional Information
You can find more information about the modification to the model Medicare Redetermination Notice (for partly or fully unfavorable redeterminations) by going to CR 5836, located at http://www.cms.hhs.gov/Transmittals/downloads/R1408CP.pdf on the CMS Web site. The updated Medicare Claims Processing Manual, Chapter 29, Section 320.7 (Medicare Redetermination Notice (for partly or fully unfavorable redeterminations)) is an attachment to that CR. The Reconsideration Request Form is also attached to CR5836.

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

Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases

News Flash ― Test Your Medicare Claims Now! After you have submitted claims containing both National Provider Identifiers (NPIs) and legacy identifiers and those claims have been paid, Medicare urges you to send a small batch of claims now with only the NPI in the primary provider fields. If the results are positive, begin increasing the number of claims in the batch. (Reminder: For institutional claims, the primary provider fields are the Billing and Pay-to Provider fields. For professional claims, the primary provider fields are the Billing, Pay-to, and Rendering Provider fields. If the Pay-to Provider is the same as the Billing Provider, the Pay-to Provider does not need to be identified.)

Provider Types Affected
Providers and suppliers who bill Medicare contractors (fiscal intermediaries (FI), regional home health intermediaries (RHHI), carriers, Medicare Administrative Contractors (A/B MAC), and Durable Medical Equipment Contractors (DME MAC) for nebulized beta adrenergic agonist therapy services for lung diseases.

What You Need to Know
CR 5820, from which this article is taken, provides that (effective September 10, 2007) no National Coverage Determination (NCD) for nebulized beta adrenergic agonist therapy for lung diseases is appropriate. Therefore, you should make sure that your billing staffs are aware that local contractors will continue to make Section 1862(a) (1) (A) reasonable and necessary decisions through a local coverage determination process or case-by-case adjudication.

Note: No changes to process or policy are being made with CR5820.

Background
Lung diseases such as chronic obstructive pulmonary disease (COPD) and asthma are characterized by airflow limitation that may be partially or completely reversible. Pharmacologic treatment with bronchodilators (intended to improve the movement of air into and from the lungs by relaxing and dilating the bronchial passageways) is used to prevent and/or control daily symptoms that may cause disability for persons with these diseases.

Beta adrenergic agonists (which can be administered via nebulizer, metered dose inhaler, orally, or dry powdered inhaler) are a commonly prescribed class of bronchodilator drug. For example, nebulized beta adrenergic agonist with racemic albuterol has been used for many years, and more recently, levalbuterol, the (R) enantiomer of racemic albuterol, has been used in some patient populations.

Because of concerns regarding the appropriate use of nebulized beta adrenergic agonist therapy for lung disease, the Centers for Medicare & Medicaid Services (CMS) internally generated a formal request for a national coverage determination (NCD) to determine when treatment with a nebulized beta adrenergic agonist is reasonable and necessary for Medicare beneficiaries with COPD.

The examination of the published medical evidence did not provide sufficient information that would enable CMS to define, at this time, specific populations of patients who would benefit from a particular treatment with particular medications. Moreover, because an NCD is defined, in part, as including “whether or not a particular item or service is covered nationally” under title XVIII, sections 1862(l), 1869(f)(1)(B); CMS does not believe a national policy is possible or prudent at this time.

Therefore, effective with dates of service on and after September 10, 2007, Medicare contractors will continue to make 1862(a)(1)(A) reasonable and necessary decisions and process claims for nebulized beta adrenergic agonist therapy for lung disease through their local coverage determination process or case-by-case adjudication.

Note: No changes to process or policy are being made with CR5820.

Additional Information
You can find the official instruction, CR 5820, issued to your FI, RHHI, Carrier, A/B MAC, or

DME MAC by visiting http://www.cms.hhs.gov/Transmittals/downloads/R79NCD.pdf on the CMS Web site. You will find the Medicare National Coverage Determinations Manual, Chapter 1, Part 4 (Sections 200 – 310.1) Coverage Determinations, Section 200.2 - Nebulized Beta Adrenergic Agonist Therapy for Lung Diseases – (Effective September 10, 2007) as an attachment to that CR.

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

News Flash ― It’s seasonal flu time again! If you have Medicare patients who haven’t yet received their flu shot, you can help them reduce their risk of contracting the seasonal flu and potential complications by recommending an annual influenza and a one-time pneumococcal vaccination. Medicare provides coverage for flu and pneumococcal vaccines and their administration. And don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot—Not the Flu! Remember — Influenza vaccination is a covered Part B benefit but the influenza vaccine is NOT a Part D covered drug. Health care professionals and their staff can learn more about Medicare’s coverage of adult immunizations and related provider education resources, by reviewing Special Edition MLN Matters article SE0748 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0748.pdf on the CMS Web site.

New Healthcare Common Procedure Coding System (HCPCS) Modifiers when Billing for Patient Care in Clinical Research Studies

News Flash ― An additional election period for the Competitive Acquisition Program (CAP) for Medicare Part B drugs will start on January 15 and run through February 15, 2008, to give physicians a chance to take advantage of new changes to the program that began on January 1, 2008. The CAP is a voluntary program that provides an alternative to ASP for physicians to obtain certain Part B drugs. More information about the CAP is available at http://www.cms.hhs.gov/CompetitiveAcquisforBios/01_overview.asp on the CMS Web site.

Provider Types Affected
Physicians, providers, and suppliers who bill Medicare contractors (carriers, fiscal intermediaries (FIs), including Regional Home Health Intermediaries (RHHIs), Medicare Administrative Contractors (A/B MACs) and Durable Medical Equipment Medicare Administrative Contractors (DME MACs)) for services provided to Medicare beneficiaries in clinical research studies.

What Providers Need to Know
This article is based on Change Request (CR) 5805. The Centers for Medicare & Medicaid Services (CMS) is discontinuing the QA (FDA Investigational Device Exemption), QR (Item or Service Provided in a Medicare Specified Study), and QV (Item or Service Provided as Routine Care in a Medicare Qualifying Clinical Trial) HCPCS modifiers as of December 31, 2007, and creating two new modifiers that will be used solely to differentiate between routine and investigational clinical services.

These new modifiers will be included in the 2008 Annual HCPCS Update and are effective for dates of service on and after January 1, 2008:

Q0 - Investigational clinical service provided in a clinical research study that is in an approved clinical research study. Q0 replaces QA and QR.
Q1 - Routine clinical service provided in a clinical research study that is in an approved clinical research study. Q1 replaces QV.

Use these two new modifiers as follows:
Investigational clinical services are defined as those items and services that are being investigated as an objective within the study. Investigational clinical services may include items or services that are approved, unapproved, or otherwise covered (or not covered) under Medicare.

Routine clinical services are defined as those items and services that are covered for Medicare beneficiaries outside of the clinical research study; are used for the direct patient management within the study; and, do not meet the definition of investigational clinical services. Routine clinical services may include items or services required solely for the provision of the investigational clinical services (e.g., administration of a chemotherapeutic agent), clinically appropriate monitoring, whether or not required by the investigational clinical service (e.g., blood tests to measure tumor markers), and items or services required for the prevention, diagnosis, or treatment of research related adverse events (e.g., blood levels of various parameters to measure kidney function).

Medicare contractors will not search their files to adjust affected claims processed prior to implementation of this change, but they will adjust such claims that you bring to their attention.

Note: If a Category A or B investigational device is used on the clinical trial, providers should continue to include the Investigational Device Exemption (IDE) in item 23 of the CMS-1500 claim form or the electronic equivalent. Also, your Medicare contractor will validate the IDE# number when it appears on the claim with the Q0 modifier and if the IDE# does not meet validation criteria, the claim will be returned as unprocessable.

Additional Information
If you have questions, please contact your Medicare A/B MAC, FI, DMERC, DME/MAC, RHHI or carrier at their toll-free number which may be found at
http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.
You may see the official instruction (CR5805) issued to your Medicare A/B MAC, FI, DMERC, DME/MAC, RHHI or carrier by going to
http://www.cms.hhs.gov/Transmittals/downloads/R1418CP.pdf on the CMS Web site.

News Flash ― It’s Not Too Late to Get the Flu Shot. We are in the midst of flu season and a flu vaccine is still the best way to prevent infection and the complications associated with the flu. But re-vaccination is necessary each year because flu viruses change each year. Please encourage your Medicare patients who haven’t already done so to get their annual flu shot. And don’t forget to immunize yourself and your staff. Protect yourself, your patients, and your family and friends. Get Your Flu Shot — Not the Flu! Remember — Influenza vaccination is a covered Part B benefit. Note that influenza vaccine is NOT a Part D covered drug. Health care professionals and their staff can learn more about Medicare’s coverage of adult immunizations and related provider education resources, by reviewing Special Edition MLN Matters article SE0748 at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0748.pdf on the CMS Web site.

 

Outpatient Therapy Caps With Exceptions Start January 1, 2008

Note: This article was revised on January 18, 2008, to reflect changes to CR5871, which CMS revised on January 17. The CR release date, transmittal number, implementation date, and Web address for accessing CR5871 were changed. All other information remains the same.

News Flash – Effective March 1, 2008, Medicare fee-for-service 837P and CMS-1500 claims must include an NPI in the primary fields on the claim (i.e., the billing, pay-to, and rendering fields). You may continue to submit NPI/legacy pairs in these fields or submit only your NPI on the claim. You may not submit claims containing only a legacy identifier in the primary fields. Failure to submit an NPI in the primary fields will result in your claim being rejected or returned as unprocessable beginning March 1, 2008. Until further notice, you may continue to include legacy identifiers only for the secondary fields.

Provider Types Affected
Therapists and other providers who bill Medicare contractors (carriers, fiscal intermediaries (FIs), or Medicare Administrative Contractors (A/B MAC)) for therapy services for Medicare beneficiaries.

Provider Action Needed
CR 5871, from which this article is taken announces the dollar amount of outpatient therapy caps for 2008, and clarifies the Medicare Claims Processing Manual regarding exceptions to outpatient therapy services.

On January 1, 2008, the financial limits on outpatient therapy services will be $1,810 for combined physical therapy and speech-language pathology services; and $1,810 for occupational therapy services.

You should make sure that your billing staffs are aware of these new outpatient therapy caps. You might also want to refer to the updated Medicare Claims Processing Manual, Chapter 5 (Part B Outpatient Rehabilitation and CORF/OPT Services), Section 10.2 (The Financial Limitation), for the complete documentation of the outpatient therapy services exceptions clarification