July 7, 2008 Part B Medicare Bulletin
Posted July 7, 2008
Table of Contents
- Ambulance Fee Schedule — Conversion Factor File for CY 2009 Ambulance Inflation Factor
- Assignment of Providers to Medicare Administrative Contractors
- Attention Part B Medicare Providers: Provider
Enrollment Training Now Available on the CGS
Web site! - Average Sales Price (ASP) Updates
- Blood-Derived Products for Chronic, Non-Healing Wounds
- CIGNA Government Services Allowable Amounts for the Drugs Emend and Treanda
- Clinical Laboratory Fee Schedule — New Waived Tests
- Date of Service (DOS) for Clinical Laboratory and Pathology Specimens
- Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program: Grandfathering, Repair and Replacement, Mail Order Diabetic Supplies and Advance Beneficiary Notices (ABNs) — The second in a series of articles on the new DMEPOS competitive bidding program
- From AdvanceMed Corporation: Place of Service Coding for Physician Services
- Important Exceptions and Special Circumstances that
Occur under the Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program: – The third in
a series of articles on the new DMEPOS competitive bidding program - July Quarterly Update for 2008 Durable Medical Equipment,
Prosthetics, Orthotics and
Supplies (DMEPOS) Fee Schedule - July Quarterly Update to 2008 Annual Update of HCPCS
Codes Used for Skilled Nursing Facility
(SNF) Consolidated Billing (CB) Enforcement - July Update to the 2008 Medicare Physician Fee Schedule Database (MPFSDB)
- New Chapter in Medicare Claims Processing Manual for
Independent Diagnostic Testing
Facilities (IDTF) - Overview of New Medicare Competitive Bidding Program
for Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies (DMEPOS) – The first in a series of articles on the
implementation of this program - Phase 1 of Manual Revisions to Reflect Payment Changes
for Durable Medical Equipment,
Prosthetics, Orthotics and Supplies (DMEPOS) Items as a Result of the DMEPOS Competitive Bidding Program and the Deficit Reduction Act of 2005 - Pre-Bidding Activities for the Medicare Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Competitive Bidding Program - Quarterly Update to Correct Coding Initiative (CCI) Edits, Version 14.2, Effective July 1, 2008
- Reminder that Exceptions to Therapy Caps are Restricted as of July 1, 2008
- Reporting of Hematocrit or Hemoglobin Levels on All
Claims for the Administration of
Erythropoiesis Stimulating Agents (ESAs), Implementation of New Modifiers for Non-ESRD ESA
Indications, and Reporting of Hematocrit or Hemoglobin Levels on all Non-ESRD, Non-ESA Claims
Requesting Payment for Anti-Anemia Drugs - Rescinded:MM5890
- Therapy Personnel Qualifications and Policies Effective January 1, 2008
- Transthoracic Echocardiography (TTE) and Transesophageal Echocardiography (TEE)
- Vascular Cryoplasty Revisited
Ambulance Fee Schedule — Conversion Factor File for CY 2009 Ambulance Inflation Factor
News Flash — Don't be Surprised on May 23 . . . TRY NPI-ONLY NOW - Now that the NPI is required on all Medicare claims in the primary provider fields, if your claims are being successfully processed with NPI/legacy pairs (and most are) now is the time to begin sending a small batch of claims with NPI alone. If the Medicare NPI Crosswalk cannot match your NPI to your Medicare legacy number, the claim with an NPI-only will reject. You can and should try sending NPI-only now! If the claim is processed and you are paid, continue to increase the volume of claims sent with only your NPI. If the claims reject, go into your NPPES record and validate that the information you are sending on the claim is consistent with the information in NPPES. If it is different, make the updates in NPPES and resend a small batch of claims 3-4 days later. If your claims are still rejecting, you may need to update your Medicare enrollment information to correct this problem. Call the Customer Service Representative at your Medicare carrier, FI, or A/B MAC or at your DME MAC to discuss your situation and, if necessary, have it investigated. Have a copy of your NPPES record or your NPI Registry record available. The contractor telephone numbers are likely to be quite busy, so don't wait.
Note: This article was revised on May 6, 2008, to correct the implementation date of the instruction. That date is October 6, 2008. All other information remains the same.
Provider Types Affected
Ambulance providers and suppliers submitting claims to Medicare contractors
(carriers, Fiscal Intermediaries (FIs), and/or Part A/B Medicare Administrative
Contractors (A/B MACs)) for ambulance services provided to Medicare beneficiaries.
What Providers Need to Know
This article is based on Change Request (CR) 6000, which revises the ambulance
fee schedule file layout for Calendar Year (CY) 2009. Specifically, only
the conversion factor field is being modified to:
- Remove the sign in the numeric field; and
- Expand the length of the Conversion Factor field.
For claims with dates of service on or after January 1, 2009, Medicare contractor(s) will recognize the new Ambulance Fee Schedule file layout. For claims with dates of service prior to January 1, 2009, Medicare contractors will recognize the current layout.
Additional Information
The official instruction, CR 6000, issued to your carrier, FI, or A/B MAC
regarding this change may be viewed at http://www.cms.hhs.gov/Transmittals/downloads/R1499CP.pdf on the Centers for Medicare & Medicaid Services (CMS) Web site.
The ambulance fee schedule public use files are available at http://www.cms.hhs.gov/AmbulanceFeeSchedule/02_afspuf.asp on the CMS Web site.
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 on the CMS Web site.
Assignment of Providers to Medicare Administrative Contractors
News Flash — The Medicare Appeals Process: Five Levels to Protect
Providers, Physicians and Other Suppliers brochure has been updated and
is now available to order print copies or as a downloadable PDF file. To
view the PDF file, go to http://www.cms.hhs.gov/MLNProducts/downloads/MedicareAppealsProcess.pdf or to order hard copies, please visit the MLN Product Ordering Page at
http://cms.meridianksi.com/kc/main/kc_frame.asp?kc_ident=kc0001&loc=5 on the CMS Web site.
Provider Types Affected
All physicians, providers, and suppliers who submit claims to Medicare
Administrative Contractors A/B MACs), fiscal intermediaries (FIs), carriers
or Regional Home Health Intermediaries (RHHIs) for services provided
to Medicare beneficiaries.
Impact on Providers
This "One Time Notice" CR describes the Centers for Medicare & Medicaid
Services (CMS) approach for assigning providers to MACs and discusses the
process of moving providers to MACs.
Background
This article is based on CR 5979 and Section 911 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108–173,
amended Title XVIII of the Social Security Act (the
Act) to add section
1874A, Contracts with Medicare Administrative Contractors (MACs).
I. What are "MACs?"
Under section 911 of the MMA, Congress requires that CMS replace the current
fiscal intermediary (FI) and carrier contracts with competitively procured
contracts that conform to the Federal Acquisition Regulation (FAR). Under
the new Medicare Administrative Contractor (MAC) contracting authority,
CMS has 6 years - between 2005 and 2011 - to complete the transition
of Medicare Fee-for-Service (FFS) claims processing activities from the
FIs and carriers to the MACs.
For information on CMS' progress in awarding and implementing the MACs, please visit http://www.cms.hhs.gov/MedicareContractingReform/ on the CMS Web site.
II. What is "Provider Nomination?"
"Provider Nomination" is a phrase that describes the former
right of an individual provider or a chain of providers to select assignment
to the FI of its choice. In section 911(b) of the MMA, Congress repealed
the provider nomination provisions of the Social Security Act. Provider
nomination has been replaced with the geographic assignment rule. Generally,
a provider will be assigned to the MAC that covers the state where the
provider is located. The CMS regulation at 42 CFR 421.404 reflects this
policy shift. Other CMS regulations and policy manuals are in the process
of being updated.
A moratorium was placed on the "change of intermediary" process for individual providers in October of 2005. Transmittal 291 (CR # 5720), dated September 19, 2007, (see http://www.cms.hhs.gov/Transmittals/downloads/R291OTN.pdf on the CMS Web site) informed all FIs and A/B MACs that CMS would no longer accept a request to move from one FI/MAC to another FI/MAC from a provider moving in or out of a Medicare chain. There remains one exception for qualified chain providers (QCPs) as discussed in Section V below.
III. Where will providers eventually be assigned in the MAC environment?
A. Home Health & Hospice
All home health and hospice (HH&H) providers will be assigned to the
MAC contracted by CMS to administer HH&H claims for the geographic
locale in which the provider is physically located. See the following link
for a description of the MAC-environment HH&H regions and the four
MACs that will administer HH&H claims for those four regions.
http://www.cms.hhs.gov/MedicareContractingReform/06_SpecialtyMACJurisdictions.asp#TopOfPage
B. Durable Medical Equipment
Each supplier of durable medical equipment, prosthetics, orthotics, and
supplies (DMEPOS) will submit claims to the Durable Medical Equipment
Medicare Administrative Contractors (DME MAC) contracted by CMS to administer
DMEPOS claims for the geographic locale in which the beneficiary permanently
resides. The link above under "A" also provides a description
of the MAC-environment DMEPOS regions and the four MACs that will administer
DMEPOS claims for those four regions.
C. Qualified Railroad Retirement Beneficiaries Entitled to Medicare
Physicians and other suppliers (except for DMEPOS suppliers) will continue
to enroll with and bill the contractor designated by the Railroad Retirement
Board (under Section 1842(g) of The Act) for Part B services furnished
to these beneficiaries. Suppliers of DMEPOS will bill the DME MACs.
D. Specialty Providers and Demonstrations
Specialty providers, and providers involved with certain demonstrations,
will submit claims to a specific MAC designated by CMS. A list of those
specialty services and their designated MACs is reflected in the following
table:
| Specialty Service or Demonstration |
MAC Jurisdiction |
|---|---|
| Centralized Billing for Mass Immunizers | 4 |
| Indian Health Services | 4 |
| Low Vision Demonstration | 5,10, 11, 13, and 14 |
| Rural Community Hospital Demonstration | 1, 2, 4 and 5 |
| Veterans Affairs Medicare Equivalent Remittance Advice Project | 4 |
| Chiropractic Services Demonstration | 4 and 5 |
| Home Health Third Party Liability Demonstration Project | 14 |
| Medicare Adult Day Care Demonstration | 11, 14 and 15 |
| Independent Organ Procurement Organizations | 10 |
| Religious Non-medical Health Care Institution (RNHCI) | 10 |
| Histocompatibility Lab | 10 |
The following material describes the demonstrations and specialty providers listed above. Generally, a provider will already know whether or not it is participating in one of these categories.
Centralized Billing for Mass Immunizers - In order to encourage providers to supply flu and pneumococcal (PPV) vaccinations to Medicare beneficiaries, CMS currently authorizes a limited number of providers to centrally bill for flu and PPV immunization claims. Centralized billing is an optional program available to providers who qualify to enroll with Medicare as the provider type "Mass Immunizer," as well as to other individuals and entities that qualify to enroll as regular Medicare providers. Centralized billers must roster bill, must accept assignment, and must bill electronically.
To qualify for centralized billing, a mass immunizer must be operating in at least three payment localities for which there are three different carriers processing claims. Centralized billers must send all claims for flu and PPV immunizations to a single carrier for payment, regardless of the carrier jurisdiction in which the vaccination was administered and the carrier must make payment based on the payment locality where the service was provided. IOM Pub. 100-04, Chapter 18, Sections 10.3 and 10.3.1 provide more specific information related to this activity.
Indian Health Services - The Indian Health Service (IHS) is the primary health care provider to Medicare beneficiaries who are members of federally recognized tribes living on or near reservations. The Indian health care system, consisting of tribal, urban, and federally operated IHS health programs, delivers a spectrum of clinical and preventive health services to its beneficiaries via a network of hospitals (including CAHs), freestanding clinics, FQHCs, RHCs and other entities.
While §§1814(c) and 1835(d) of the Social Security Act (the Act), as amended, generally prohibit payment to any Federal agency, passage of the Indian Health Care Improvement Act (IHCIA) in 1976 provided for an exception, amending §1880 of the Act, for facilities of the IHS whether operated by such Service or by an Indian tribe or tribal organization (as defined in section 4 of the IHCIA). The exception under § 1880 limited payment to Medicare services provided in hospitals and skilled nursing facilities.
Effective July 1, 2001, the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), §432 extended payment on a fee-for-service (FFS) basis to services of physician and non-physician practitioners furnished in IHS hospitals and freestanding clinics. This means that clinics associated with hospitals and freestanding clinics that are owned and/or operated by IHS are authorized to bill only the Jurisdiction 4 MAC. Additionally, Tribal health facilities operated under Indian Self Determination Education and Assistance Act (ISDEAA) authorities are an extension of the IHS and considered facilities of the IHS. By virtue of this, they are authorized to bill the Jurisdiction 4 MAC. ISDEAA authorities rovide flexibilities to tribes in the administration of their programs that are not provided to general public providers.
Low Vision Demonstration - The Secretary of the Department of Health and Human Services is directed to carry out an outpatient vision rehabilitation demonstration project as part of the FY 2004 appropriations conference report to accompany Public Law HR 2673. This demonstration project will examine the impact of standardized Medicare coverage for vision rehabilitation services provided in the home, office, or clinic, under the general supervision of a physician. The services may be supplied by the following:
- Physicians;
- Occupational therapists;
- Certified low vision therapists;
- Certified orientation and mobility specialists; and
- Certified vision rehabilitation therapists.
This demonstration will last for five (5) years through March 31, 2011, and is limited to services provided specifically in New Hampshire, New York City (all 5 boroughs), North Carolina, Atlanta, Kansas, and Washington State.
Rural Community Hospital Association - The RCH Demonstration Program was mandated by section 410A of the MMA. The Secretary is required to conduct the RCH Demonstration, lasting five (5) years, to test the advisability and feasibility of establishing RCHs to provide Medicare covered inpatient hospital services in rural areas. This Demonstration will allow selected rural hospitals to benefit from cost-based reimbursement for inpatient services.
The Secretary is required to select not more than fifteen (15) hospitals to participate in the demonstration in States with low population densities. Currently, thirteen (13) hospitals participate in the program, serviced by seven different Fiscal Intermediaries (FIs).
Veteran Affairs Medicare Equivalent Remittance Advice Project - Current law permits the Department of VA to collect appropriate Medicare coinsurance and deductible amounts from supplemental insurers for claims for supplies and services ordinarily covered by Medicare but furnished:
- At VA facilities; and
- For veterans eligible to receive both VA health and Medicare benefits and also having Medicare supplemental insurance.
To facilitate this process, the Centers for Medicare & Medicaid Services (CMS) entered into an interagency agreement with the VA whereby the CMS will help the VA work with a CMS contractor to adjudicate these claims to produce a remittance advice equivalent that ordinarily produced for Medicare claims. The remittance advice, sent to the supplemental insurers, will help the insurers determine payment amounts they owe to the VA. The CMS will not pay these claims. Trailblazer was the contractor selected to perform the work.
Chiropractic Services Demonstration - Section 651 of the MMA requires the Centers for Medicare & Medicaid Services (CMS) to conduct the Expansion of Coverage for Chiropractic Services Demonstration. The purpose of the demonstration is to evaluate the feasibility and advisability of expanding coverage of chiropractic services under Medicare. The demonstration is for two years and must be conducted in four geographic areas—two rural and two urban.
Home Health Third Party Liability Demonstration - The CMS and the States of Connecticut, Massachusetts, and New York have developed a demonstration program that will use a sampling approach to determine the Medicare share of the cost of home health services claims for dual eligible beneficiaries that were submitted to and paid by the Medicaid agencies. Sampling will be used in lieu of individually gathering Medicare claims from home health agencies (HHAs) for every dual eligible Medicaid claim each State may have paid in error. This process will eliminate the need for the HHAs to assemble, copy, and submit large numbers of medical records. The project currently covers the home health claims incurred in fiscal years (FY) 2000 through 2007 for Massachusetts and New York and FY 2001 through 2005 for Connecticut.
Medicare Adult Day Care Demonstration - Section 703 of the MMA directs CMS to conduct a demonstration project that will test an alternative approach to the delivery of Medicare home health services. Under this demonstration, Medicare beneficiaries receiving home health may be eligible to receive medical adult day care services as a substitute for a portion of home health services that would otherwise be provided in the beneficiary's home. The statute requires the demonstration to run for a period of three (3) years at no more than five (5) HHA sites in states that license certified medical adult day care facilities.
Implementation of the demonstration began at five (5) sites on August 1, 2006. Participation of Medicare beneficiaries is voluntary; up to 15,000 beneficiaries at any time will be eligible to enroll in the three (3)-year demonstration.
Medicare Home Health Agency Provider Enrollment Demonstration - This demonstration is designed to combat fraudulent home health activity in the Houston and Los Angeles areas. The principal provider enrollment task will be the revalidation of all HHAs in said areas.
Independent Organ Procurement Organizations – An Organ Procurement Organization performs or coordinates the retrieval, preservation, and transportation of organs and maintains a system of locating prospective recipients for available organs.
Religious Non-Medical Health Care Institutions – A RNHCI provides care to beneficiaries in need of skilled nursing facility care or hospital care when the beneficiary's religious beliefs preclude admission to one of these institutional providers. This does not mean that the beneficiary will receive hospital or SNF care in the RNHCI, but that the beneficiary elected to pursue a religious approach to healing. Since the use of diagnoses or medical oversight is prohibited in a RNHCI, they are not candidates for any CMS existing PPS and continue to be paid using the TEFRA methodology.
Histocompatibility Lab - Histocompatibility Laboratories provide services related to tissue typing testing for possible organ recipients and donors to determine compatibility for an organ transplant. They operate on a cost reimbursement basis and bill transplant centers for their services.
E. The Geographic-Assignment Rule
Providers that are not within one of the categories described above (HH&H,
DME, RRB, or specialty & demos) will be assigned to the MAC that covers
the state where the provider is located. There are two exceptions.
First a qualified chain provider (QCP) may request that its member providers be serviced by a single A/B MAC - specifically, the A/B MAC that covers the state where the QCP's home office is located. The regulation at 42 CFR 421.404(b)(2) defines a qualified chain provider (QCP) as:
- Ten or more hospitals, skilled nursing facilities, and/or critical access hospitals, under common ownership or control, collectively totaling 500 or more certified Medicare beds; or
- Five or more hospitals, skilled nursing facilities, and/or critical access hospitals, under common ownership or control in three or more contiguous states, collectively totaling 300 or more certified Medicare beds.
CMS may assign non-QCP providers, as well as End Stage Renal Disease (ESRD)
providers to an A/B MAC outside of the prevailing geographic assignment
rule only to support the implementation of the MACs or to serve some other
compelling interest of the Medicare program.
The second exception is for providers that meet the "provider-based" criteria
of 42 CFR 413.65. Provider-based entities (other than HH+H providers) will
be assigned to the MAC that covers the state where the main ("parent")
provider is assigned.
IV. Where will providers be assigned in the interim?
All existing providers with a Medicare claims history will remain in their
current FI assignments until their workload is transferred to an A/B
MAC. The "change of intermediary" process ended for individual
providers in 2005, and ended for chain providers in 2007. A change of
ownership now serves only to update CMS provider data with information
about the new owner.
The workload currently serviced by a legacy FI will be absorbed by the incoming MAC within the 12 months following the award of MAC contract. In some situations the workload transition may be delayed by an award protest.
New providers enrolling with Medicare will be assigned to the FI or MAC that covers the state where the provider is physically located, with a few exceptions:
- The "Multi-Provider Complex/Sub-Unit" relationship (ref: 42 CFR 483.5(b)). - An initial enrollment for a sub-unit will be assigned to the FI or MAC that currently serves the existing parent hospital – even if the parent hospital is not presently billing in accordance with the "geographic assignment rule."
- An "initial enrollment" connected with a QCP. - If a QCP acquires a new hospital, skilled nursing facility, or critical access hospital that is located outside home office A/B MAC jurisdiction, then CMS will endeavor to assign the provider to the MAC that covers the state where the QCP's home office is located. This special assignment is available only for "initial enrollments" – providers that are joining the Medicare program with neither an existing administrative contractor assignment nor a Medicare claims history.
The other exceptions track the MAC-world assignment rules discussed in Sections III-A through III-D above.
V. How long will my interim assignment last?
An "out-of-jurisdiction provider" (OJP) is a provider that
is not currently assigned to the A/B MAC or FI in accordance with Sections
III-A through III-D above (including the geographic assignment rule.) For
example, an individual, freestanding provider located in Oregon, but currently
assigned to the Florida FI, would be an OJP.
New MACs will initially service some OJPs until CMS undertakes the final reassignment of all OJPs to their destination MACs based on the geographic assignment rule.
CMS will start the overall transfer of OJPs to their final destination MACs after two events have taken place. The first event is when all 15 A/B MACs have been awarded and implemented. The second event is when all the systems and contractors that support the claims processing, provider enrollment, and cost report auditing functions at the departure and destination MACs are capable of supporting the move.
Additional Information
For complete details regarding this CR please see the official instruction
(CR5979) issued to your Medicare FI, A/B MAC, or RHHI. That instruction
may be viewed by going to http://www.cms.hhs.gov/Transmittals/downloads/R333OTN.pdf on
the CMS Web site. To view any of the federal regulations cited in this
article or in CR5979, visit http://www.cms.hhs.gov/Transmittals/downloads/R333OTN.pdf on the Internet.
If you have questions, please contact your Medicare FI, A/B MAC, or RHHI at their toll-free number which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.
Attention Part B Medicare Providers: Provider Enrollment Training Now Available on the CGS Web site!
You asked for help, and CGS has delivered. We are happy to inform the Provider Community that we have added Provider Enrollment Online Education Courses to the CGS Web site.
These courses are designed to provide an overview of the enrollment process, help providers decide which application to complete based on their situation, and to assist providers in completing the CMS 855 Enrollment Applications.
These online education courses are available at the following links to
the CIGNA Government Services Web site:
http://www.cignagovernmentservices.com/medicare_dynamic/Education/index.asp
http://www.cignagovernmentservices.com/partb/enrollment/index.html
Average Sales Price (ASP) Updates
News Flash ― The Medicare Appeals Process: Five Levels to Protect
Providers, Physicians and Other Suppliers brochure has been updated and
is now available to order print copies or as a downloadable PDF file. To
view the PDF file, go to http://www.cms.hhs.gov/MLNProducts/downloads/MedicareAppealsProcess.pdf
or to order hard copies, please visit the MLN Product Ordering Page at
http://cms.meridianksi.com/kc/main/kc_frame.asp?kc_ident=kc0001&loc=5 on the CMS Web site.
Provider Types Affected
Physicians, providers, and suppliers who submit claims to Medicare contractors
(carriers, fiscal intermediaries (FIs), Part A/B Medicare Administrative
Contractors (A/B MACs), and DME Medicare Administrative Contractors (DME
MACs)) for services provided to Medicare beneficiaries.
Provider Action Needed
This article is based on Change Request (CR) 5798 and provides you with
updates and additions to language in the Medicare
Claims Processing Manual relating to the ASP drug pricing and payment methodology. This article
is informational to advise providers that the information is now in the
Medicare manual and this information has been supplied in prior MLN Matters
articles.
Key Points
The Centers for Medicare & Medicaid Services (CMS) provides an ASP
file to each FI, carrier, DME MAC, and A/B MAC for pricing drugs. Each
FI, carrier, DME MAC, and A/B MAC must accept the ASP files made available
by CMS for pricing bills/claims for any drug identified on the price files
as these files are the single national payment limit established by CMS.
- The payment limits included in the revised ASP and Not Otherwise Classified (NOC) payment files supersede the payment limits for these codes in any earlier publication.
ASP Payment Methodology
- The ASP methodology is based on quarterly data submitted to CMS by manufacturers and the updated and new guidelines established that relate to ASP pricing, payment methodology, and exceptions, are stated in Chapter 17, Section 20 of the Medicare Claims Processing Manual at http://www.cms.hhs.gov/manuals/downloads/clm104c17.pdf on the CMS Web site.
- The absence or presence of a Healthcare Common Procedure Coding System (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. Your local Medicare contractor processing the claim will make these determinations.
- The vast majority of drugs and biologicals not priced on a cost or prospective payment basis will be priced based on the ASP methodology.
- Pricing for compounded drugs is done by your local contractor.
- End Stage Renal Disease (ESRD) drugs furnished by both independent and hospital-based ESRD facilities, as well as specified covered outpatient drugs, and drugs and biologicals with pass-through status under the Outpatient Prospective Payment System (OPPS), will be priced based on the ASP methodology.
- 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.
- The payment allowance limits for ESRD drugs when separately billed by freestanding and hospital-based ESRD facilities, as well as specified covered outpatient drugs, and drugs and biologicals with pass-through status under the OPPS, will be paid based on 106 percent of the ASP.
- For the purposes of identifying "single source drugs" and "biological
products" subject to payment under Section 1847A, generally CMS
(and its contractors) will utilize a multi-step process, in which CMS
considers:
- The Food & Drug Administration (FDA) approval;
- Therapeutic equivalents as determined by the FDA; and
- The date of first sale in the United States.
- For a biological product (as evidenced by a new FDA Biologic License Application or other relevant FDA approval) or a single source drug (that is, not a drug for which there are two or more drug products that are rated as therapeutically equivalent in the most recent FDA Orange Book) first sold in the United States after October 1, 2003, the payment limit for a biological product or single source drug 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, which may be made operational through use of "not otherwise classified" HCPCS codes.
Exceptions to the ASP Payment Methodology
- The payment allowance limits for blood and blood products (other than blood clotting factors) that are not paid on a reasonable charge or prospective payment basis, are determined in the same manner the payment allowance limits 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 for infusion drugs furnished through a covered item of durable medical equipment on or after January 1, 2005, will continue to be 95 percent of the AWP reflected in the published compendia as of October 1, 2003, unless the drug is compounded or the drug is furnished incident to a professional service. The payment allowance limits for infusion drugs furnished through a covered item of durable medical equipment that were not listed in the published compendia as of October 1, 2003, (i.e., new drugs) are 95 percent of the first published AWP unless the drug is compounded or the drug is furnished incident to a professional service.
- The payment allowance limits for influenza, Pneumococcal and Hepatitis
B vaccines are 95 percent of the AWP as reflected in the published compendia
except where the vaccine is furnished in a hospital outpatient department.
Where the vaccine is administered in the hospital outpatient department,
the vaccine is paid at reasonable cost.
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, other than new drugs that are produced or distributed under a new drug application (or other application) approved by the FDA, are based on the published Wholesale Acquisition Cost (WAC) or invoice pricing, except under OPPS where the payment allowance limit is 95 percent of the published AWP. In determining the payment limit based on WAC, the contractors follow the methodology specified in the Medicare Claims Processing Manual, Chapter 17, Drugs and Biologicals, http://www.cms.hhs.gov/manuals/downloads/clm104c17.pdf on the CMS Web site, for calculating the AWP, but substitutes WAC for AWP. The payment limit is 100 percent of the lesser of the lowest-priced brand or median generic WAC. - Carriers, DME MACs, and A/B MACs will develop payment allowance limits for covered drugs when CMS does not supply the payment allowance limit on the ASP drug pricing file.
- The payment allowance limits for new drugs and biologicals that are produced or distributed under a new drug application (or other new application) approved by the FDA, and that are not included in the ASP Medicare Part B Drug Pricing File or Not Otherwise Classified (NOC) Pricing File, are based on 106 percent of the WAC, or invoice pricing if the WAC is not published, except under OPPS where the payment allowance limit is 95 percent of the published AWP.
- The payment allowance limits for radiopharmaceuticals are not subject to ASP. Carriers will 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. Please refer to Chapter 17, Section 90.2 of the Medicare Claims Processing Manual regarding radiopharmaceuticals furnished in the hospital outpatient department.
Additional Information
You may see the official instruction (CR5798) issued to your Medicare contractor
by visiting http://www.cms.hhs.gov/Transmittals/downloads/R1513CP.pdf on the CMS Web site.
If you have 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.
The ASP methodology files are posted at
http://www.cms.hhs.gov/McrPartBDrugAvgSalesPrice/ on the CMS Web site.
Blood-Derived Products for Chronic, Non-Healing Wounds
News Flash — The
Medicare Appeals Process: Five Levels to Protect Providers, Physicians
and Other Suppliers brochure has been updated and
is now available to order print copies or as a downloadable PDF file. To
view the PDF file, go to http://www.cms.hhs.gov/MLNProducts/downloads/MedicareAppealsProcess.pdf or to order hard copies, please visit the MLN Product Ordering Page at
http://cms.meridianksi.com/kc/main/kc_frame.asp?kc_ident=kc0001&loc=5
on the CMS Web site.
Provider Types Affected
Physicians, providers, and suppliers submitting claims to Medicare contractors
(carriers, Fiscal Intermediaries (FIs), and/or Part A/B Medicare Administrative
Contractors (A/B MACs)) for services provided to Medicare beneficiaries.
Provider Action Needed
STOP – Impact to You
This article is based on Change Request (CR) 6043 which provides the Centers
for Medicare & Medicaid Services (CMS) updated policy regarding autologous
blood-derived products for chronic, non-healing wounds.
CAUTION – What You Need to Know
Effective March 19, 2008, CMS is maintaining its current non-coverage determination
for autologous platelet rich plasma (PRP) for the treatment of chronic,
non-healing cutaneous wounds, and issuing a non-coverage determination
for acute surgical wounds when the autologous PRP is applied directly to
the closed incision and for dehiscent wounds.
GO – What You Need to Do
See the Background and Additional Information Sections of this article
for further details.
Background
In 1992, the Centers for Medicare & Medicaid Services (CMS) issued
a national non-coverage determination for autologous, platelet-derived
wound healing formulas intended to treat patients with chronic, non-healing
wounds.
In December 2003, CMS issued a national non-coverage determination for use of autologous platelet rich plasma (PRP) for the treatment of chronic non-healing cutaneous wounds except for routine costs when used in accordance with the clinical trial policy defined in the Medicare National Coverage Determinations (NCD) Manual (Section 310.1; see http://www.cms.hhs.gov/manuals/downloads/ncd103c1_Part4TXT.pdf on the CMS Web site).
In April 2005, CMS issued an NCD to correct the erroneous potential for local coverage of becaplermin, a non-autologous growth factor for chronic non-healing subcutaneous wounds, stating that, because it is usually self-administered, it would remain nationally non-covered under Part B based on the Social Security Act (Section 1861(s)(2)(A) and (B); see http://www.ssa.gov/OP_Home/ssact/title18/1861.htm on the Internet).
On March 19, 2008, CMS issued a Decision Memorandum following a National Coverage Analysis to evaluate the use of autologous blood-derived products for the treatment of chronic, non-healing cutaneous wounds, specifically the use of autologous PRP for the treatment of acute wounds where PRP is applied directly to the closed incision site, or for dehiscent wounds.
CMS determined that the evidence is inadequate to conclude that autologous PRP for the treatment of chronic non-healing cutaneous wounds, acute surgical wounds when the autologous PRP is applied directly to the closed incision, or dehiscent wounds, improves health outcomes in the Medicare population.
Therefore, effective March 19, 2008, CMS is maintaining its current non-coverage determination for autologous PRP for the treatment of chronic, non-healing cutaneous wounds, and issuing a non-coverage determination for acute surgical wounds when the autologous PRP is applied directly to the closed incision and for dehiscent wounds. Effective for claims with dates of service on or after March 19, 2008, the use of autologous PRP for the treatment of acute surgical wounds where the PRP is applied directly to the closed incision, or dehiscent wounds, will be denied by Medicare contractors.
Additional Information
The official instruction, CR 6043, issued to your carrier, FI, and A/B
MAC regarding this change may be viewed at http://www.cms.hhs.gov/Transmittals/downloads/R83NCD.pdf on the CMS Web site.
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 on the CMS Web site.
CIGNA Government Services Allowable Amounts for the Drugs Emend and Treanda
***UPDATE***
| Participating | Non-participating | |
| fosaprepitant dimeglumine for Injection (Emend): | $185.500 | $176.225 |
| bendamustine (Treanda) | $1,908.000 | $1,812.600 |
Clinical Laboratory Fee Schedule - New Waived Tests
News Flash ― The Clinical Laboratory Fee Schedule Fact Sheet, which provides general information about the Clinical Laboratory Fee Schedule, coverage of clinical laboratory services, and how payment rates are set, is now available in downloadable format from the Centers for Medicare & Medicaid Services Medicare Learning Network at http://www.cms.hhs.gov/MLNProducts/downloads/clinical_lab_fee_schedule_fact_sheet.pdf on the CMS Web site. The Clinical Laboratory Fee Schedule Fact Sheet, is also available in print format. To place your order, visit http://www.cms.hhs.gov/mlngeninfo/, scroll down to "Related Links Inside CMS" and select "MLN Product Ordering Page."
Provider Types Affected
Clinical diagnostic laboratories that bill Medicare Carriers or Part
A/B Medicare Administrative Contractors (A/B MACs) for laboratory tests.
What You Need to Know
CR 6021 announces the latest tests that the Food and Drug Administration
(FDA) has approved (effective July 1, 2008) as waived tests under the
Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Please be aware that In order for a laboratory with a valid, current certificate of waiver to bill for these tests, the assigned Current Procedural Terminology (CPT) codes must contain the QW modifier. The new waived tests, CPT codes, and effective dates for each are provided in Table 1, below.
Make sure that your billing staffs are aware of these newly approved FDA waived tests under CLIA.
Background
Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations
require that a laboratory facility be appropriately certified for each
test that it performs. Further, these regulations require facilities
with a Certificate of Waiver (COW) to perform only CLIA waived tests
Note: To ensure that Medicare only pays laboratories with a CLIA certificate of waiver for tests that are approved as waived complexity under the Clinical Laboratory Fee Schedule (CLFS), laboratory claims are currently edited at the CLIA certificate level.
In addition, the Centers for Medicare & Medicaid Service (CMS) is mandated by Section 1833(h) of the Social Security Act to add updated test codes to the CLFS, and CR 6021 announces the latest tests that the FDA has approved as waived tests under CLIA.
In order for a CLIA-enrolled, waived laboratory to bill for these tests, the Current Procedural Terminology (CPT) codes associated with them must contain a QW modifier. Table 1, below, lists the CPT codes, descriptions, and effective dates for these latest tests that the FDA has approved as waived tests under CLIA. Please note that the CPT codes for the tests in the table must have the modifier QW to be recognized as waived tests.
| FDA-Approved Waived Tests under CLIA | |
|---|---|
| CPT Code | Description |
| 80047QW dates of service on or after January 1, 2008 |
Basic Metabolic Panel (Calcium, Ionized) |
| 80048QW dates of service on or after January 16, 2008 |
Basic Metabolic Panel, (Calcium, total) |
| 80051QW dates of service on or after October 30, 2007 |
Electrolyte Panel |
| 80053QW dates of service on or after January 16, 2008 |
Comprehensive Metabolic Panel |
| 82042QW dates of service on or after October 4, 2006 |
Albumin; Urine or Other source, Quantitative, Each Specimen |
| 82150QW dates of service on or October 4, 2006 |
Amylase |
| 82247QW dates of service on or after October 4, 2006 |
Bilirubin; Total |
| 82977QW dates of service on or after October 4, 2006 |
Glutamyltransferase, Gamma (GGT) |
| 84075QW dates of service on or after October 4, 2006 |
Phosphatase, Alkaline |
| 84157QW dates of service on or after October 4, 2006 |
Protein, Total, Except by Refractometry; Other Source (e.g., Synovial Fluid, Cerebrospinal Fluid) |
| 84520QW dates of service on or after October 4, 2006 |
Urea Nitrogen; Quantitative |
| 87808QW dates of service on or after January 1, 2007 |
Infectious Agent Antigen Detection by Immunoassay with Direct Optical Observation; Trichomonas Vaginalis |
| 87999QW dates of service on or after July 1, 2007 |
Unlisted Microbiology Procedure |
Be aware that carriers and A/B MACS will not search their files to either retract payment or retroactively pay claim processed prior to implementation of CR6021, but they will adjust such claims if you bring them to their attention.
Additional Information
You can find the official instruction to your carrier or A/B MAC by going
to CR 6021, located at http://www.cms.hhs.gov/Transmittals/downloads/R1527CP.pdf on CMS Web site.
If you have any questions, please contact your carrier or A/B MAC at their toll-free number, which may be found at http://www.cms.hhs.gov/MLNProducts/downloads/CallCenterTollNumDirectory.zip on the CMS Web site.
Date of Service (DOS) for Clinical Laboratory and Pathology Specimens
News Flash ― The Clinical Laboratory Fee Schedule Fact Sheet, which provides general information about the Clinical Laboratory Fee Schedule, coverage of clinical laboratory services, and how payment rates are set, is now available in downloadable format from the Centers for Medicare & Medicaid Services Medicare Learning Network at http://www.cms.hhs.gov/MLNProducts/downloads/clinical_lab_fee_schedule_fact_sheet.pdf on the CMS Web site. The Clinical Laboratory Fee Schedule Fact Sheet, is also available in print format. To place your order, visit http://www.cms.hhs.gov/mlngeninfo/, scroll down to "Related Links Inside CMS" and select "MLN Product Ordering Page."
Provider Types Affected
Providers who submit claims to Medicare Administrative Contractors (A/B
MACs), fiscal intermediaries (FIs) or carriers, for laboratory tests,
or the technical component of physician pathology services, provided
to Medicare beneficiaries.
Impact on Providers
This article is based on Change Request (CR) 6018 alerting providers that
the Centers for Medicare & Medicaid Services (CMS) revised the DOS
policy for clinical laboratory tests and added the technical component
of physician pathology service effective January 1, 2009. These changes
were announced in the final Medicare physician fee schedule rule published
in the Federal Register on November 27, 2007 (42 CFR § 414.510).
Key Points of CR6018
The DOS policy as specified in 42 CFR § 414.510 for either a clinical
laboratory test or the technical component of physician pathology service
is as follows:
- General Rule: The DOS of the test/service must be the date the specimen was collected.
- Variation: If a specimen is collected over a period that spans two calendar days, then the DOS must be the date the collection ended.
The following two exceptions apply to this DOS policy for either a clinical laboratory test or the technical component of physician pathology service:
- DOS for Tests/Services Performed on Stored Specimens:
In the case of a test/service performed on a stored specimen, if a specimen was stored for less than or equal to 30 calendar days from the date it was collected, the DOS of the test/service must be the date the test/service was performed only if:
- The test/service is ordered by the patient's physician at least 14 days following the date of the patient's discharge from the hospital;
- The specimen was collected while the patient was undergoing a hospital surgical procedure;
- It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted;
- The results of the test/service do not guide treatment provided during the hospital stay; and
- The test/service was reasonable and medically necessary for treatment of an illness.
If the specimen was stored for more than 30 calendar days before testing, the specimen is considered to have been archived and the DOS of the test/service must be the date the specimen was obtained from storage.
- DOS for Chemotherapy Sensitivity Tests/Services Performed on Live Tissue:
In the case of a chemotherapy sensitivity test/service performed on live tissue, the DOS of the test/service must be the date the test/service was performed only if:
- The decision regarding the specific chemotherapeutic agents to test is made at least 14 days after discharge;
- The specimen was collected while the patient was undergoing a hospital surgical procedure;
- It would be medically inappropriate to have collected the sample other than during the hospital procedure for which the patient was admitted;
- The results of the test/service do not guide treatment provided during the hospital stay; and
- The test/service was reasonable and medically necessary for treatment of an illness.
For purposes of applying the above exception, a "chemotherapy sensitivity test" is defined as a test that requires a fresh tissue sample to test the sensitivity of tumor cells to various chemotherapeutic agents. CMS identifies such tests through program instructions issued to the Medicare contractors.
Additional Information
For complete details regarding this CR please see the official instruction
(CR6018) issued to your Medicare FI, A/B MAC, or carrier. That instruction
may be viewed by going to http://www.cms.hhs.gov/Transmittals/downloads/R1515CP.pdf on the CMS Web site.
If you have questions, please contact your Medicare FI, A/B MAC, 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.
Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program: Grandfathering, Repair and Replacement, Mail Order Diabetic Supplies and Advance Beneficiary Notices (ABNs) – The second in a series of articles on the new DMEPOS competitive bidding program
News Flash ― Now available ― CMS' Newly Redesigned DMEPOS Competitive Bidding Web Page. This dedicated Web page provides one-stop shopping for Medicare providers, suppliers, and referral agents who want the most current and reliable information on this new program. Features include links to policy information such as the Metropolitan Statistical Areas and Product Categories included in Round One, Federal regulations, notices and manual instructions, provider educational products and resources, Frequently Asked Questions, and more. You can see the latest announcements and communications sent to the Medicare provider community here as well. The web address is: http://www.cms.hhs.gov/DMEPOSCompetitiveBid. We encourage you to bookmark this NEW page as we will continue to post new information and resources!
Note: This article was revised on June 2, 2008, to add the Web address for viewing the new Chapter 36 of the Medicare Claims Processing Manual. That chapter contains the initial, official manual instructions for the DMEPOS Competitive Bidding Program. All other information remains the same.
Provider Types Affected
Any Medicare Fee-for-Service (FFS) provider supplying DMEPOS to a Medicare
beneficiary. This article also contains information of interest to those
who order DMEPOS and to referral agents as defined in MLN Matters article
SE0805.
Provider Action Needed
The first article (SE0805) in this series on the DMEPOS Competitive Bidding
Program being instituted by the Centers for Medicare & Medicaid Services
(CMS) presented an overview of how the program may affect your patients.
There are also some key provisions of the program about which your patients
may raise questions. While the competitive bidding program only affects
ten areas of the country as of July 1, 2008, it will expand to 70 additional
geographic areas in 2009. Thus, it is important for you to be familiar
with this program.
Background
MLN Matters article SE0805, entitled "Overview of New Medicare Competitive
Bidding Program for Durable Medical Equipment, Prosthetics, Orthotics,
and Supplies (DMEPOS)," which is available at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0805.pdf on the CMS Web site, summarizes information on competitive bidding that
may impact your patients. Article SE0805 contains the list of competitive
bidding areas for the first phase of competitive bidding as well as a list
of the DMEPOS product categories that are included in the program's
initial implementation.
In using this series of DMEPOS articles, it is important to remember that in most instances, beneficiaries maintaining a permanent residence in one of the Competitive Bidding Areas (CBAs) must obtain competitive bidding items from a contract supplier. There are also program requirements that apply to beneficiaries who reside in CBAs but travel outside of those CBAs and to beneficiaries who do not live in CBAs but travel to them.
Grandfathered Suppliers
The Medicare DMEPOS Competitive Bidding Program requires Medicare beneficiaries
to obtain competitive bidding items from a contract supplier, unless
an exception applies. Therefore, in some instances, your patient may
be required to change from a non-contract supplier to a contract supplier.
However, the program does allow for certain suppliers to be "grandfathered." Grandfathered
suppliers are allowed to continue to provide certain rented DME items
and services even though they are not contract suppliers.
Grandfathering only applies when the patient is renting DME or oxygen equipment at the time the competitive bidding program becomes effective and the rental period for the item began before the start of the competitive bidding program.
Beneficiaries who are receiving oxygen, oxygen equipment, or rented DME at the time the competitive bidding program becomes effective may elect to continue to receive these items from a non-contract supplier, if the supplier is willing to continue furnishing these items. If a non-contract supplier chooses not to be "grandfathered" or if a beneficiary wants to change to a contract supplier, the non-contract supplier must pick up the rental equipment and oxygen equipment.
Unless a beneficiary relocates outside of the CBA and the supplier service area, the supplier cannot discontinue services by picking up a medically necessary item prior to the end of a rental month for which the supplier was eligible to receive a rental payment, even if the last day of a rental month is after the start date of the program. If the date of the beginning of a monthly rental period is prior to the start of the competitive bidding program, the supplier must submit a claim for that month. Note that the grandfathering provision also applies to Medicare beneficiaries who transition from a Medicare Advantage Plan to the Fee-for-Service program.
If the beneficiary stays with a "grandfathered" supplier, he or she may elect to change to a contract supplier at any time, and the contract supplier would be required to accept the beneficiary as a customer. For more details on the grandfathering provision, visit http://www.dmecompetitivebid.com on the CMS Web site.
Repair and Replacement of Beneficiary-Owned Items
Repair ONLY
A beneficiary who owns a competitively bid item that needs to be repaired
may have the repairs performed by either a contract supplier or by a
non-contract supplier. In these cases, Medicare pays for reasonable and
necessary labor not otherwise covered under a manufacturer's or
supplier's warranty.
Repair and Replacement
If a part needs to be replaced in order to make the beneficiary-owned equipment
serviceable, and the replacement part is also a competitively bid item
for the CBA in which the beneficiary maintains a permanent residence,
the part may be obtained from either a contract supplier or a non-contract
supplier. In either case, Medicare pays the single payment amount provided
under the Competitive Bidding Program for the replacement part.
Replacement ONLY
Beneficiaries maintaining permanent residences in a CBA are required to
obtain replacement of all items subject to competitive bidding from a
contract supplier. This includes replacement of base equipment and replacement
of parts or accessories for base equipment that are being replaced for
reasons other than servicing of the base equipment.
Beneficiaries who are not permanent residents of a CBA but require a replacement of a competitively bid item while visiting a CBA, must obtain the replacement item from a contract supplier. The supplier will be paid the fee schedule amount for the state where the beneficiary is a permanent resident.
Mail Order Diabetic Supplies under the Program
Medicare beneficiaries who permanently reside in a CBA may purchase their
diabetic testing supplies from:
- A mail order contract supplier for the area in which the beneficiary maintains a permanent residence; or
- A non-contract supplier in cases where the supplies are not furnished on
a mail order basis.
The mail order contract period covers diabetic testing supplies furnished from July 1, 2008 through March 31, 2010. The term "mail order" refers to items ordered remotely (i.e., by phone, email, internet, or mail) and delivered to the beneficiary's residence by common carriers (e.g., U.S. Postal Service, Federal Express, United Parcel Service) and does not include items obtained by beneficiaries from local supplier storefronts.
Mail order contract suppliers will be reimbursed at the single payment amount for the CBA where the beneficiary maintains a permanent residence.
For diabetic supplies that are not furnished through mail order, suppliers will be paid the fee schedule amount.
Medicare payment will not be made to non-contract suppliers that furnish mail order diabetic testing supplies to Medicare beneficiaries residing in a CBA. A special modifier, KL, will be used on each claim to indicate that the item was furnished on a mail order basis.
Note: Suppliers that furnish diabetic testing supplies on a mail order basis and do not attach the mail order modifier could be subject to significant penalties under the False Claims Act.
Both the Medicare program and beneficiaries will save money each time a mail order contract supplier is used; however, it is solely up to the beneficiaries to decide whether or not they wish to obtain their diabetic testing supplies on a mail order basis.
All mail order contract suppliers are required to report the manufacturer or make and model number of products they furnish and must update this list on a quarterly basis. This information will be made available to the public once the contract suppliers have been announced and will be updated on a routine basis. Contract suppliers will be required to make available the same range of products to Medicare beneficiaries that they make available to non-Medicare customers.
Advance Beneficiary Notice (ABN) Information
In general, if a non-contract supplier in a CBA furnishes a competitively
bid item to any Medicare beneficiary regardless of whether that beneficiary
maintains a permanent residence in the CBA or another area, and no applicable
exceptions apply, Medicare will not make payment. In addition, the beneficiary
is not liable for payment unless the non-contract supplier in a CBA obtains
an ABN signed by the beneficiary.
A signed ABN indicates that the beneficiary was informed in writing prior to receiving the item that there would be no Medicare coverage due to the supplier's contract status, and that the beneficiary understands that he/she will be liable for all costs that the non-contract supplier may charge the beneficiary for the item.
If a non-contract supplier furnishes a competitively bid item to a beneficiary and the beneficiary signs an ABN, the supplier must use the "GA" modifier on their claim. If the "GA" modifier is not present on the claim, the supplier may not hold the beneficiary liable for the cost of the item.
Additional Information
CMS contracted with the Competitive Bidding Implementation Contractor (CBIC)
to administer the DMEPOS Competitive Bidding Program. Downloadable Patient
Education Fact Sheets can be found at:
http://www.dmecompetitivebid.com/palmetto/CBIC.nsf/docsCat/CBIC~Referral%20Providers~Patient%20Education%20Fact%20Sheets?open&cat=CBIC~Referral%20Providers~Patient%20Education%20Fact%20Sheets.
If you have concerns, questions, or complaints about the quality of an item or the service that a patient received from a contract supplier, please call the Competitive Bidding Program helpline at 1.877.577.5331.
CMS has released a new Chapter 36 of the Medicare Claims Processing Manual. This chapter is part of CR5978 and contains the initial, official manual instructions for this program. The MLN Matters article related to CR5978 is available at http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5978.pdf on the CMS Web site.
For more information about the Competitive Bidding Program, call 1.877.577.5331. TTY users call 1.877.486.2048. Stay tuned for additional articles in this series. You can also visit http://www.cms.hhs.gov/DMEPOSCompetitiveBid/ on the CMS Web site or http://www.dmecompetitivebid.com/ on the Internet for more details.
From AdvanceMed Corporation: Place of Service Coding for Physician Services
Medicare has established facility versus non-facility rates for services performed by physicians. The non-facility rates such as place of service 11 (office) have a higher payment rate to adjust for overhead costs incurred by physicians. The facility rate such as place of service 22 (hospital) should be billed where a physician's office is located within the hospital. If the facility furnishes the office space at no charge to the provider, then the facility is entitled a facility fee from Part A and the Part B provider would not bill Place of Service (POS) 11.
Physicians are required to identify the place of service on the claims they submit to Medicare. This ensures that correct payment is made and duplicate payments to the facility and physician are avoided. For physicians to receive the higher non-facility payment for a service, the service must meet the requirements of 42 CFR §414.22(b)(5)(i)(B), which states in part:
- The higher non-facility practice expense RVUs apply to services performed in a physician's office, a patient's home, an ASC if the physician is performing a procedure not on the ACS approved procedures list, a nursing facility, or a facility or institution other than a hospital or skilled nursing facility, community mental health center, or ASC performing an ASC approved procedure.
The provider should refer to the National POS Code Set, which provides facility and non-facility designations for Medicare payment for services that are listed on the Physician Fee Schedule.
AdvanceMed conducted a study to identify Medicare Part B services submitted with place of service 11 (office) where a Part A facility fee was paid by Medicare for the same beneficiary on the same date of service. Claims data was compiled from January 1, 2004 through December 31, 2006 for paid services billed by Part B physicians for office visits and consultations. The Part B data was matched to the Part A data on the same beneficiary receiving a service from the same procedure code ranges in both the Part B office setting as well as the Part A outpatient setting. The paid services included the following Current Procedural Terminology (CPT) codes:
99201 – 99205
99211 – 99215
99241 - 99245
The results of this study identified numerous Medicare providers that met the above criteria. AdvanceMed has assessed overpayments and educated the providers that were discovered in the facility versus non-facility study.
Important Exceptions and Special Circumstances that Occur under the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program: – The third in a series of articles on the new DMEPOS competitive bidding program.
News Flash ― Now available ― CMS' Newly Redesigned DMEPOS Competitive Bidding Web Page. This dedicated Web page provides one-stop shopping for Medicare providers, suppliers, and referral agents who want the most current and reliable information on this new program. Features include links to policy information such as the Metropolitan Statistical Areas and Product Categories included in Round One, Federal regulations, notices and manual instructions, provider educational products and resources, Frequently Asked Questions, and more. You can see the latest announcements and communications sent to the Medicare provider community here as well. The Web address is: http://www.cms.hhs.gov/DMEPOSCompetitiveBid. We encourage you to bookmark this NEW page as we will continue to post new information and resources!
Note: This article was revised on June 2, 2008, to add the Web address for viewing the new Chapter 36 of the Medicare Claims Processing Manual. That chapter contains the initial, official manual instructions for the DMEPOS Competitive Bidding Program. All other information remains the same.
Provider Types Affected
The following providers may be affected by this program:
- Physicians and other treating practitioners who are Medicare enrolled DMEPOS suppliers;
- Physicians and others who order or refer DMEPOS items or services for their patients;
- Skilled nursing facilities (SNFs) and nursing facilities (NFs); and
- Physical therapists and occupational therapists in private practice who are Medicare enrolled DMEPOS suppliers.
Many Medicare Fee-for-Service (FFS) providers may be in a position of ordering, referring, or supplying DMEPOS to a Medicare beneficiary. This includes physicians (including podiatric physicians), other treating practitioners (nurse practitioners, physician assistants, and clinical nurse specialists), physical and occupational therapists, and institutional providers (especially skilled nursing facilities and their social workers or care coordinators, hospitals and their discharge planners, home health agencies and pharmacists).
Provider Action Needed
Understand these special program rules that may affect you. This article
is especially important if you are a Medicare-enrolled DMEPOS supplier
of items governed by the new program, even if you are not located in
a competitive bidding area (CBA). It is important to understand that
the program affects any beneficiaries who permanently reside in or travel
to CBAs. Some program requirements apply to beneficiaries who reside
in CBAs even if these beneficiaries travel outside their CBAs. Thus,
it is important for you to be familiar with this program.
While the first phase of the competitive bidding program only affects ten CBAs in the country as of July 1, 2008, the second phase will expand to 70 additional geographic areas in 2009. See MLN article SE0805 for information about CBAs and items governed by this new program and for information about how the program applies to traveling beneficiaries.
Background
MLN Matters article SE0805 that is entitled, "Overview of New Medicare
Competitive Bidding Program for Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS)," which is available at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0805.pdf on the CMS Web site, summarizes information on competitive bidding that
may impact your patients. Article SE0805 contains the list of competitive
bidding areas for the first phase of competitive bidding as well as a list
of the DMEPOS product categories that are included in the program's
initial implementation.
MLN Matters article SE0806 that is entitled, "Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program: Grandfathering, Repair and Replacement, Mail Order Diabetic Supplies, and Advanced Beneficiary Notices (ABNs)," which is available at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0806.pdf on the CMS Web site, provides an overview of the rules regarding grandfathered suppliers, repair and replacement of beneficiary-owned equipment, mail order diabetic supplies under the program, and ABNs.
In this, the third in a series of articles on the new DMEPOS competitive bidding program, we provide information on some special circumstances and exceptions of particular interest to physicians and other treating practitioners, SNFs and NFs , and physical and occupational therapists in independent practice.
Note: It is important to note that the Competitive Bidding Program does
not affect your patients' choice of physician or treating practitioner.
In using this series of DMEPOS articles, remember that in most instances,
beneficiaries maintaining a permanent residence in one of the Competitive
Bidding Areas (CBAs) must obtain competitive bidding items from a contract
supplier. There are also program requirements that apply to beneficiaries
who reside in CBAs but travel outside of those CBAs and to beneficiaries
who do not live in CBAs but travel to them.
Physicians and Other Treating Practitioners Who are Enrolled Medicare
DMEPOS Suppliers
Medicare physicians and treating practitioners who have also enrolled as
Medicare DMEPOS suppliers via the 855S enrollment form have the option
to furnish certain types of competitively bid items to their own patients
without submitting a bid or being awarded a competitive bid contract, provided
the following requirements are met:
- For the first phase of the program being implemented July 1 2008, the item furnished must be a walker. In the future, the items will be limited to crutches, canes, walkers, folding manual wheelchairs, blood glucose monitors, and infusion pumps that are DME;
- The items must be furnished by the physician or treating practitioner DMEPOS supplier to his or her own patients as part of his or her professional service; and
- The items must be billed to a DME MAC using the DMEPOS billing number that is assigned to the physician, the treating practitioner (if possible), or a group practice to which the physician or treating practitioner has reassigned the right to receive Medicare payment.
Where the furnished item is a bid item and the beneficiary resides in a CBA, the physician or treating practitioner will be paid the single payment amount established by this program for the item. This exception does not affect the applicability of the physician self-referral (Stark law) provisions in section 1877 of the Act. All provisions of the physician self-referral law remain fully in effect.
Physicians and Other Treating Practitioners Who Prescribe Specific Brand
or Mode of Delivery to Avoid an Adverse Medical Outcome
A physician (including a podiatric physician) or treating practitioner
may prescribe, in writing, a particular brand of DMEPOS bid item or mode
of delivery for an item if he or she determines that the particular brand
or mode of delivery would avoid an adverse medical outcome for the beneficiary.
The physician or treating practitioner must document in the beneficiary's
medical record the reason why the specific brand or mode of delivery is
necessary to avoid an adverse medical outcome.
In these cases, the contract supplier under the Competitive Bidding Program must:
- Furnish the particular brand or mode of delivery as prescribed by the physician or treating practitioner;
- Consult with the physician or treating practitioner to find another appropriate brand of item or mode of delivery for the beneficiary and obtain a revised written prescription from the physician or treating practitioner; or
- Assist the beneficiary in locating a contract supplier that can furnish the particular brand of item or mode of delivery prescribed by the physician or treating practitioner.
Any change in the prescription requires a revised written prescription. A contract supplier is prohibited from submitting a claim to Medicare if it furnishes an item different from that specified in the written prescription received from the beneficiary's physician or treating practitioner.
Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs) Specialty
Suppliers
The DMEPOS Competitive Bidding Program applies to SNFs and NFs to the extent
that their residents receive competitively bid items under Medicare Part
B. Unlike most suppliers, SNFs and NFs have the option to bid for, and
be awarded, contracts to be "specialty suppliers" that only
furnish competitively bid items to their own residents. SNFs and NFs that
become specialty suppliers may not furnish competitively bid items and
services to Medicare beneficiaries outside their facilities for purposes
of Medicare payment. SNFs and NFs can also become regular contract suppliers
that furnish competitively bid items to beneficiaries throughout a CBA.
If a SNF or NF is not a contract supplier (either a specialty contract supplier or a regular contract supplier), it must use a contract supplier for its CBA to furnish competitively bid items to its residents.
Physical Therapists and Occupational Therapists in Private Practice Who
are Enrolled Medicare DMEPOS Suppliers
Physical therapists and occupational therapists in private practice who
are enrolled DMEPOS suppliers may eventually have the option to furnish
certain types of competitively bid items to their own patients and be paid
the single payment amount for such items without being contract suppliers,
provided the following requirements are met:
- The items are limited to off-the-shelf (OTS) orthotics; and
- The items must be furnished only to their own patients as part of the physical or occupational therapy service.
Note: OTS orthotics are not included in the first phase of competitive bidding, this exception is not relevant in the first phase of the DMEPOS Competitive Bidding program beginning July1, 2008.
Additional Information
CMS has released a new Chapter 36 of the Medicare Claims Processing Manual.
This chapter is part of CR5978 and contains the initial, official manual
instructions for this program. The MLN Matters article related to CR5978
is available at http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5978.pdf on the CMS Web site.
If you have concerns, questions, or complaints about the quality of an item or the service that a patient received from a contract supplier please call the Competitive Bidding Program helpline at 1.877.577.5331.
For more information about the Competitive Bidding Program, call 1.877.577.5331. TTY users call 1.877.486.2048. Stay tuned for additional articles in this series. You can also visit http://www.dmecompetitivebid.com/palmetto/cbic.nsf/DocsCat/Home on the Internet and at http://www.cms.hhs.gov/DMEPOSCompetitiveBid/ on the CMS Web site for more details.
July Quarterly Update for 2008 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule
News Flash ― Now available ― CMS' Newly Redesigned DMEPOS Competitive Bidding Web Page. This dedicated Web page provides one-stop shopping for Medicare providers, suppliers and referral agents who want the most current and reliable information on this new program. Features include links to policy information such as the Metropolitan Statistical Areas and Product Categories included in Round One, Federal regulations, notices and manual instructions, provider educational products and resources, Frequently Asked Questions, and more. You can see the latest announcements and communications sent to the Medicare provider community here as well. The Web address is: http://www.cms.hhs.gov/DMEPOSCompetitiveBid. We ncourage you to bookmark this NEW page as we will continue to post new information and resources!
Note: This article was revised on June 2, 2008, to reflect an effective date (see above) of January 1, 2008. All other information remains the same.
Provider Types Affected
Providers and suppliers submitting claims to Medicare contractors (carriers,
DME 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 DMEPOS provided to Medicare
beneficiaries.
Provider Action Needed
This article is based on Change Request (CR) 6022, which provides the quarterly
update to the July 2008 DMEPOS fee schedules in order to implement fee
schedule amounts for new codes and to revise any fee schedule amounts
for existing codes that were calculated in error. Be sure your billing
staffs are aware of these changes.
Background
This recurring update notification, CR6022, provides specific instructions
regarding the July quarterly update for 2008 for the DMEPOS fee schedule.
Payment on a fee schedule basis is required for durable medical equipment
(DME), prosthetic devices, orthotics, prosthetics, and surgical dressings
by §1834(a), (h), and (i) of the Social Security Act. Payment on
a fee schedule basis is required for parenteral and enteral nutrition
(PEN) by regulations contained at 42 CFR 414.102.
The update process for the DMEPOS fee schedule is located in the Medicare Claims Processing Manual, Chapter 23, Section 60, which is available at http://www.cms.hhs.gov/manuals/downloads/clm104c23.pdf on the Centers for Medicare & Medicaid Services (CMS) Web site. Other information on the fee schedule, including access to the DMEPOS fee schedules is at http://www.cms.hhs.gov/DMEPOSFeeSched/01_overview.asp on the CMS Web site.
Key Points
The following Healthcare Common Procedure Coding System (HCPCS) codes were
added to the HCPCS file effective January 1, 2008 and the fee schedule
amounts for these HCPCS codes may be established as part of this update
and are effective for claims with dates of service on or after January
1, 2008.
| Code | Description | Code | Description |
| A5083 | Continent device, stoma absorptive cover for continent stoma. | E0856 | Cervical traction device, cervical collar with inflatable air bladder. |
| E2227 | Manual wheelchair accessory, gear reduction drive wheel, each. | E2228 | Manual wheelchair accessory, wheel braking system and lock, complete, each. |
| E2397 | Power wheelchair accessory, lithium-based battery, each. | L3927 | Finger orthosis, proximal interphalangeal (pip)/distal interphalangeal (dip),without joint/spring, extension/flexion (e.g. static or ring type), may include soft interface material, prefabricated, includes fitting and adjustment. |
| L7611 | Terminal device, hook, mechanical, voluntary opening, any material, any size, lined or unlined, pediatric. | L7612 | Terminal device, hook, mechanical, voluntary closing, any material, any size, lined or unlined, pediatric |
| L7613 | Terminal device, hand, mechanical, voluntary opening, any material, any size, pediatric | L7614 | Terminal device, hand, mechanical, voluntary closing, any material, any size, pediatric |
| L7621 | Terminal device, hook or hand, heavy duty, mechanical, voluntary opening, any material, any size, lined or unlined. | L7622 | Terminal device, hook or hand, heavy duty, mechanical, voluntary closing, any material, any size, lined or unlined. |
- The above codes were paid on a local fee schedule basis prior to implementation of the fee schedule amounts established in accordance with this update. Claims for these codes with dates of service on or after January 1, 2008 that have already been processed will not be adjusted to reflect the newly established fees if they are resubmitted for adjustment.
- The fee schedule amounts for the following codes are being revised as part of this quarterly update to correct fee schedule calculation errors and the revised fee schedule amounts will be added to the fee schedule file as part of this update.
| Code | Description | Code | Description |
| L3905 | Wrist hand orthosis, includes one or more nontorsion joints, elastic bands. Turnbuckles, may include soft interface, straps, custom fabricated, includes fitting and adjustment. | L3806 | Wrist hand finger orthosis, includes one or more nontorsion joint(s), turnbuckles, elastic bands/springs, may include soft interface material straps, custom fabricated, includes fitting and adjustment. |
| L3808 | Wrist hand finger orthosis, rigid without joints, may include soft interface material; straps, custom fabricated, includes fitting and adjustment. |
- Your Medicare contractor will adjust previously processed claims for codes L3905, L3806 and L3808 with dates of service on or after January 1, 2008 if they are resubmitted for adjustments.
- HCPCS code K0672 (Addition to Lower Extremity Orthosis, Removable Soft Interface, All Components, Replacement Only, Each) was added to the HCPCS file effective April 1, 2008.
- The fee schedule amounts for HCPCS code E0461 (Volume Control Ventilator, Without Pressure Support Mode, May Include Pressure Control Mode, Used with Non-Invasive Interface (e.g. Mask)) were inadvertently dropped from the January 2008 DMEPOS fee schedule file and the file was subsequently revised to add the fee schedule amounts for code E0461.
Additional Information
For complete details regarding this CR please see the official instruction
(CR6022) issued to your Medicare contractor. That instruction may be
viewed by going to http://www.cms.hhs.gov/Transmittals/downloads/R1516CP.pdf on the CMS Web site.
If you have 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.
July Quarterly Update to 2008 Annual Update of HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement
News Flash — Effective July 1, 2008, Medicare will begin implementation of a new program for purchasing DMEPOS for Medicare patients. For Medicare beneficiaries whose permanent residence is in 1 of the 10 metropolitan statistical areas (MSAs) affected by the first phase of this program, only contract suppliers, in most instances, will be eligible to provide competitive bid items and receive payment from Medicare. While new payment rules may not impact referral agents directly, they may impact your patients.
For more information on this program, please refer to MLN Matters articles
located at http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0805.pdf,
http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0806.pdf, http://www.cms.hhs.gov/MLNMattersArticles/downloads/SE0807.pdf,
or visit at http://www.cms.hhs.gov/CompetitiveAcqforDMEPOS/ on the CMS
Web site.
Provider Types Affected
Providers submitting claims to Medicare contractors (carriers, Fiscal Intermediaries
(FIs), and/or Part A/B Medicare Administrative Contractors (A/B MACs))
for services provided to Medicare beneficiaries in Skilled Nursing Facilities.
Provider Action Needed
This notification provides updates to the lists of Healthcare Common Procedure
Coding System (HCPCS) codes that are subject to the consolidated billing
provision of the SNF Prospective Payment System (PPS). CR 6009 adds HCPCS
code J9303 (Injection, Panitumumab, 10MG) to the Major Category III.A.
Chemotherapy services FI/A/B MAC Exclusion List retroactive to January
1, 2008.
Background
The Social Security Act (Section 1888) codifies the Skilled Nursing Facility
(SNF) Prospective Payment System (PPS) and Consolidated Billing (CB).
The new coding identified in each update describes the same services
that are subject to SNF PPS payment by law. No additional services are
added by these routine updates; that is, new updates are required by
changes to the coding system, not because the services subject to SNF
CB are being redefined. Other regulatory changes beyond code list updates
will be noted when and if they occur.
The Centers for Medicare & Medicaid Services (CMS) periodically updates the lists of HCPCS codes that are not subject to the consolidated billing provision of the SNF PPS. Services not appearing on this list submitted on claims to FIs/A/B MACs and carriers/A/B MACS, including DME MACs, will not be paid by Medicare to providers, other than a SNF, when included in SNF Consolidated Billing (CB).
For non-therapy services, SNF CB applies only when the services are furnished to a SNF resident during a covered Part A stay. However, SNF CB applies to physical and occupational therapies and speech-language pathology services whenever they are furnished to a SNF resident, regardless of whether Part A covers the stay. Services excluded from SNF PPS and CB may be paid to providers, other than SNFs, for beneficiaries, even when in a SNF stay. In order to assure proper payment in all settings, Medicare systems will edit for services provided to SNF beneficiaries both included and excluded from SNF CB.
CR 6009 adds HCPCS code J9303 to the Major Category III.A. Chemotherapy services FI/A/B MAC Exclusion List retroactive to January 1, 2008.
Medicare contractors will reopen and reprocess claims affected by this instruction when providers bring such claims to their contractor's attention.
Additional Information
The official instruction, CR 6009, issued to your carrier, FI, and A/B
MAC regarding this change may be viewed at http://www.cms.hhs.gov/Transmittals/downloads/R1501CP.pdf on the CMS Web site.
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 on the CMS Web site.
July Update to the 2008 Medicare Physician Fee Schedule Database (MPFSDB)
News Flash ― Effective July 1, 2008, Medicare will begin implementation of a new program for purchasing DMEPOS for Medicare patients. For Medicare beneficiaries whose permanent residence is in 1 of the 10 metropolitan statistical areas (MSAs) affected by the first phase of this program, only contract suppliers, in most instances, will be eligible to provide competitive bid items and receive payment from Medicare. While new payment rules may not impact referral agents directly, they may impact your patients. For more information on this program, please refer to MLN Ma
