CMS

Change Request:  5205 (PDF).

Effective January 02, 2007, CR 5205 provides instructions for implementing the lab competitive bidding demonstration required by Section 302(b) of the Medicare Modernization Act of 2003 for services paid under the Medicare Part B. Pap smears and colorectal cancer screening tests are excluded.

• The project will cover demonstration tests for beneficiaries who live in demonstration sites, as determined by the beneficiary's zip code.
• Hospital inpatient testing is exempt from the demonstration.
• Physician office lab (POL) testing and hospital outpatient testing are excluded and will continue to be paid on the existing lab fee schedule, except where the lab functions as an independent lab performing testing for a non-patient.

Required Bidders
Labs with $100,000 or more in annual Medicare Part B payments for 2005 for “demonstration tests” provided to beneficiaries residing in the CBAs will be required to bid.

Passive Laboratories
Small labs with less than $100,000 in annual Medicare Part B payments for demonstration tests provided to beneficiaries residing in the CBAs will not be required to bid. Passive labs will be paid the lab competitive bidding demonstration fee schedule for demonstration tests provided to beneficiaries residing in the CBA until they exceed the annual ceiling of $100,000 at which time they will stop being paid anything by Medicare for demonstration tests provided to beneficiaries residing in the CBAs for the duration of the demonstration.

Winners
Both required and non-required bidders that bid and win will be paid the lab competitive bidding demonstration fee schedule for demonstration tests provided to beneficiaries residing in the CBAs.

Non-Winners
Both required and non-required bidders that bid and do not win may neither be paid by Medicare for demonstration tests provided to beneficiaries residing in the CBAs for the duration of the demonstration, nor may they charge the beneficiary for Part B lab services or request an ABN.

Demonstration-Covered Laboratory Tests
Only the performing lab may bill for services. Non-winner labs may neither bill Medicare or the beneficiary for any demonstration-covered services, but may refer services to a winner lab or a passive lab.
Labs will be paid according to the clinical lab fee schedule for tests and/or beneficiaries not covered under the demonstration.

Demonstration Sites
There are two demonstration sites and each site runs for three years with a staggered start of one year.

Implementation
By January 01, 2007, CMS will provide Medicare carriers and FIs with a national zip code pricing file identifying the zip codes included in CBA1; a list of the labs eligible to participate (“winners” and passive laboratories); and a list of those laboratories not selected to participate in CBA1.

For covered services in CBA1 with dates of service April 01, 2007 - March 31, 2010, Medicare will pay the lab demonstration fee schedule amounts.

Claims submitted by non-winner labs for dates of service April 01, 2007 - March 31, 2010, for Medicare beneficiaries in CBA1 will be denied using:

• Reason code 96 (non-covered charges);
• Remark code M114 (This service was processed in accordance with rules and guidelines under the Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project. If you would like more information regarding this project, you may contact your local contractor.); and
• Remark code N83 (No appeal rights. Administrative decision based on the provisions of a demonstration project.)

Using these same reason and remark codes, Medicare will reject any laboratory claims with a date of service between April 01, 2007, and March 31, 2010 with a modifier of “90” submitted by laboratories for demonstration-covered services provided to beneficiaries residing in the CBA, regardless of the referring laboratory’s participation status.

A subsequent CR will be issued with requirements to implement the demonstration in the second CBA (CBA2) with a tentative start date of April 01, 2008.

  CMS

Transmittal:  1050 (PDF).
Implementation Date: October 02, 2006

CMS has released the October 2006 update to its Medicare National Coverage Determinations (NCDs) Manual for Clinical Diagnostic Laboratory Services. This update, requires updating of the laboratory edit module. These changes become effective for services furnished on or after October 01, 2006.

Changes are being made to the NCD code lists for services furnished on or after October 01, 2006, are as follows:

190.12 - Urine Culture, Bacterial
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Urine Culture, Bacterial (190.12) NCD:

• ICD-9-CM codes 288.00, 288.01, 288.02, 288.03, 288.04, 288.09, 608.20, 608.21, 608.22, 608.23, 608.24, 616.81, 616.89, 780.96, 780.97, 788.64 and 788.65

The following ICD-9-CM codes are being deleted from the list of ICD-9-CM codes covered by Medicare for the Urine Culture, Bacterial (190.12) NCD:

• ICD-9-CM codes 288.0, 608.2 and 616.8

190.14 - Human Immunodeficiency Virus (HIV) Testing (Diagnosis)
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Human Immunodeficiency Virus (HIV) Testing (Diagnosis) (190.14) NCD:

• ICD-9-CM codes 052.2, 053.14, 054.74, 288.00, 288.01, 288.02, 288.03, 288.04, 288.09, 288.4, 288.50, 288.51, 288.59, 288.60, 288.61, 288.62, 288.63, 288.64, 288.65, 288.69, 289.53 and 331.83

The following ICD-9-CM code is being deleted from the list of ICD-9-CM codes covered by Medicare for the Human Immunodeficiency Virus (HIV) Testing (Diagnosis) (190.14) NCD:

• ICD-9-CM code 288.0

190.15 - Blood Counts
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes that do not support medical necessity for the Blood Counts (190.15) NCD:

• ICD-9-CM codes 338.0, 338.11, 338.12, 338.18, 338.19, 338.21, 338.22, 338.28, 338.29, 338.4, 389.15, 389.16, 478.11, 478.19, 521.81, 521.89, 525.60, 525.61, 525.62, 525.63, 525.64, 525.65, 525.66, 525.67, 525.69, 526.61, 526.62, 526.63, 526.69, 608.20, 608.21, 608.22, 608.23, 608.24, 618.84, V26.34, V26.35, V45.86, V72.11 and V72.19
• ICD-9-CM codes 521.8 and V72.1 are deleted from the list of codes that do not support medical necessity for the Blood Counts (190.15) NCD.

190.16 - Partial Thromboplastin Time (PTT)
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Partial Thromboplastin Time (PTT)(190.16) NCD:

• ICD-9-CM codes 238.71, 238.72, 238.73, 238.74, 238.75, 238.76, 238.79, 277.30, 277.31, 277.39, 289.81, 649.30, 649.31, 649.32, 649.33, 649.34, 649.50, 649.51, 649.53, 998.12, 995.20, 995.21, 995.27, and 995.29

The following ICD-9-CM codes are being deleted from the list of ICD-9-CM codes covered by Medicare for the Partial Thromboplastin Time (PTT)(190.16) NCD:

• ICD-9-CM codes 238.7, 277.3 and 995.2

190.17 - Prothrombin Time (PT)
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Prothrombin Time (PT) (190.17) NCD:

• ICD-9-CM codes 238.71, 238.72, 238.73, 238.74, 238.75, 238.76, 238.79, 277.30, 277.31, 277.39, 289.81, 649.30, 649.31, 649.32, 649.33, 649.34, 649.50, 649.51, 649.53, 995.20, 995.21, 995.27 and 995.29

The following ICD-9-CM codes are being deleted from the list of ICD-9-CM codes covered by Medicare for the Prothrombin Time (PT) (190.17) NCD:

• ICD-9-CM codes 238.7, 277.3 and 995.2

190.18 - Serum Iron Studies
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Serum Iron Studies (190.18) NCD:

• ICD-9-CM codes 238.71, 238.72, 238.73, 238.74, 238.75, 238.76 and 238.79

The following ICD-9-CM code is being deleted from the list of ICD-9-CM codes covered by Medicare for the Serum Iron Studies (190.18) NCD:

• ICD-9-CM code 238.7

190.20 - Blood Glucose Testing
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Blood Glucose Testing (190.20) NCD:

• ICD-9-CM codes 331.83, 528.00, 528.09, 649.20, 649.21, 649.22, 649.23, 649.24 and 780.32

The following ICD-9-CM code is being deleted from the list of ICD-9-CM codes covered by Medicare for the Blood Glucose Testing (190.20) NCD:

• ICD-9-CM code 528.0

190.22 - Thyroid Testing
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Thyroid Testing (190.22) NCD:

• ICD-9-CM codes 331.83, 780.96 and 780.97

The following ICD-9-CM code is being deleted from the list of ICD-9-CM codes covered by Medicare for the Thyroid Testing (190.22) NCD

• ICD-9-CM code 793.9

190.23 - Lipids Testing
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Lipids Testing (190.23) NCD:

• ICD-9-CM codes 277.30, 277.31 and 277.39

The following ICD-9-CM code is being deleted from the list of ICD-9-CM codes covered by Medicare for the Lipids Testing (190.23) NCD:

• ICD-9-CM code 277.3

190.24 - Digoxin Therapeutic Drug Assay
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Digoxin Therapeutic Drug Assay (190.24) NCD:

• ICD-9-CM codes 995.20, 995.21, 995.27 and 995.29

The following ICD-9-CM code is being deleted from the list of ICD-9-CM codes covered by Medicare for the Digoxin Therapeutic Drug Assay (190.24) NCD:

• ICD-9-CM code 995.2

190.25 - Alpha-fetoprotein
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Alpha-fetoprotein (190.25) NCD:

• ICD-9-CM codes V86.0, V86.1, 795.89 and 338.3

190.26 - Carcinoembryonic Antigen
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Carcinoembryonic Antigen (190.26) NCD:

• ICD-9-CM codes 795.81, 795.89 and 338.3

190.27 - Human Chorionic Gonadotropin
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Human Chorionic Gonadotropin (190.27) NCD:

• ICD-9-CM codes 795.89 and 338.3

190.28 - Tumor Antigen by Immunoassay CA 125
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Tumor Antigen by Immunoassay CA 125 (190.28) NCD:

• ICD-9-CM codes 795.82, 795.89 and 338.3

190.29 - Tumor Antigen by Immunoassay CA 15-3/CA27.29
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Tumor Antigen by Immunoassay CA 15-3/CA27.29 (190.29) NCD:

• ICD-9-CM codes 338.3 and 795.89

190.30 - Tumor Antigen by Immunoassay CA 19.9
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Tumor Antigen by Immunoassay CA 19.9 (190.30) NCD:

• ICD-9-CM codes 338.3 and 795.89

190.31 - Prostate Specific Antigen (PSA)
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Prostate Specific Antigen (PSA) (190.31) NCD:

• ICD-9-CM codes 600.00, 600.10, 600.11, 600.21, 788.64 and 788.65.

190.32 - Gamma Glutamyl Transferase (GGT)
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Gamma Glutamyl Transferase (GGT) (190.32) NCD:

• ICD-9-CM codes 238.71, 238.72, 238.73, 238.74, 238.75, 238.76, 238.79, 277.30, 277.31 and 277.39

The following ICD-9-CM codes are being deleted from the list of ICD-9-CM codes covered by Medicare for the Gamma Glutamyl Transferase (GGT) (190.32) NCD:

• ICD-9-CM codes 238.7 and 277.3

190.33 - Hepatitis Panel/Acute Hepatitis Panel
The following ICD-9-CM code of 780.32 is being added to the list of ICD-9-CM codes covered by Medicare for the Hepatitis Panel/Acute Hepatitis Panel (190.33) NCD.

190.34 - Fecal Occult Blood Test (FOBT)
The following ICD-9-CM codes are being added to the list of ICD-9-CM codes covered by Medicare for the Fecal Occult Blood Test (FOBT) (190.34) NCD:

• ICD-9-CM codes 284.2 and 338.3

The following ICD-9-CM codes are being deleted from the list of ICD-9-CM codes covered by Medicare for the Fecal Occult Blood Test (FOBT) (190.34) NCD:

• ICD-9-CM code 995.2

List of denied ICD-9-CM codes for all NCDs
The following ICD-9-CM codes are being added to the list of denied ICD-9-CM codes for all NCDs:

• ICD-9-CM codes V18.51, V18.59, V82.71 and V82.79

ICD-9-CM code V18.5 is deleted from the list of denied ICD-9-CM codes for all NCDs.

  CMS

Change Request:  5231 (PDF).

The following list are the latest tests approved by the FDA as waived tests under CLIA. The CPT codes for the following new tests must have the modifier QW to be recognized as a waived test.

  CMS

Special Edition:  SE0555 (PDF).

Beginning May 23, 2007 (May 23, 2008, for small health plans), the NPI must be used in lieu of legacy provider identifiers. Legacy provider identifiers include:

• Online Survey Certification and Reporting (OSCAR) system numbers;
• National Supplier Clearinghouse (NSC) numbers;
• Provider Identification Numbers (PINs); and
• Unique Physician Identification Numbers (UPINs) used by Medicare.

They do not include taxpayer identifier numbers (TINs) such as:

• Employer Identification Numbers (EINs); or
• Social Security Numbers (SSNs).

Primary and Secondary Providers

• Primary providers include billing, pay-to, rendering, or performing providers.
• Secondary providers include supervising physicians, operating physicians, referring providers, and so on.

Crosswalk
During Stage 2, Medicare will utilize a Crosswalk between NPIs and legacy identifiers to validate NPIs received in transactions, assist with population of NPIs in Medicare data center provider files, and report NPIs on remittance advice (RA) and coordination of benefit (COB) transactions. Key elements of this Crosswalk include the following:

• Each primary provider’s NPI reported on an inbound claim or claim status query will be cross-walked to the Medicare legacy identifier that applies to the owner of that NPI.
• The Crosswalk will be able to do a two-directional search, from a Medicare legacy identifier to NPI, and from NPI to a legacy identifier.
• The Medicare Crosswalk will be updated daily to reflect new provider registrations.

NPI Transition Plans for Medicare FFS Providers

Stage	Medicare Implementation
May 23, 2005 - January 2, 2006:	Providers should submit Medicare claims using only their existing Medicare numbers. They should not use their NPI numbers during this time period. CMS claims processing systems will reject, as unprocessable, any claim that includes an NPI during this phase.
January 3, 2006 - October 1, 2006:	Medicare systems will accept claims with an NPI, but an existing legacy Medicare number must also be on the claim. Note that CMS claims processing systems will reject, as unprocessable, any claim that includes only an NPI. Medicare will be capable of sending the NPI as primary provider identifier and legacy identifier as a secondary identifier in outbound claims, claim status response, and eligibility benefit response electronic transactions.
October 2, 2006 - May 22, 2007: (This is stage 2, the subject of CR4023)	CMS systems will accept an existing legacy Medicare billing number and/or an NPI on claims. If there is any issue with the provider’s NPI and no Medicare legacy identifier is submitted, the provider may not be paid for the claim. Therefore, Medicare strongly recommends that providers, clearinghouses, and billing services continue to submit the Medicare legacy identifier as a secondary identifier. Medicare will be capable of sending the NPI as primary provider identifier and legacy identifier as a secondary identifier in outbound claim, claim status response, remittance advice (electronic but not paper), and eligibility response electronic transactions.
May 23, 2007 – Forward:	CMS systems will only accept NPI numbers. Coordination of benefit transactions sent to small health plans will continue to carry legacy identifiers, if requested by such a plan, through May 22, 2007.

Claim Rejection
Claims will be rejected if:

• The NPI included in a claim or claim status request does not meet the content criteria requirements for a valid NPI
• An NPI reported cannot be located in Medicare files;
• The NPI is located, but a legacy identifier reported for the same provider in the transaction does not match the legacy identifier in the Medicare file for that NPI;
• Claims include the NPI but do not have a taxpayer identification number (TIN) reported for the billing or pay-to provider in electronic claims received via X12 837, DDE screen (FISS only), or Medicare’s free billing software.

X12 837 Incoming Claims and COB
During Stage 2, an X12 837 claim may technically be submitted with only an NPI for a provider, but you are strongly encouraged to also submit the corresponding Medicare legacy identifier for each NPI in X12 837 Medicare claims.

Use of both numbers could facilitate investigation of errors if one identifier or the other cannot be located in the Medicare validation file. When an NPI is reported in a claim for a billing or pay-to provider, a TIN must also be submitted in addition to the provider’s legacy identifier as required by the claim implementation guide.

Paper Claim Forms
The transition period for the revised CMS-1500 is currently scheduled to begin October 01, 2006 and end February 01, 2007. The transition period for the UB-04 is currently scheduled for March 1, 2007 - May 22, 2007.

Pending the start of submission of the revised CMS-1500 and the UB-04, providers must continue to report legacy identifiers, and not NPIs, when submitting claims on the non-revised CMS-1500 and the UB-92 paper claim forms.

Provider identifiers reported on those claim forms are presumed to be legacy identifiers and will be edited accordingly. “Old” form paper claims, received through the end of the transition period that applies to each form, may be rejected if submitted with an NPI.

Or, if they are not rejected—since some legacy identifiers were also 10-digits in length—could be incorrectly processed, preventing payment to the provider that submitted that paper claim.

  CMS

Change Request:  5210 (PDF).

Section 732 of the Medicare Modernization Act (MMA) extended, for 2005 and 2006, the provision of section 542 of the Benefits Improvement Act of 2000 (BIPA) that allowed certain independent laboratories to bill under the physician fee schedule for the technical component of physician pathology services furnished to patients of covered hospital. CR5210 instructs Medicare carriers to notify all independent laboratories that they may no longer bill for these services after the MMA provision expires on December 31, 2006.

  California — Medi-Cal

Medi-Cal Update:  GM Contents.

An article published in the July 2006 Medi-Cal Update incorrectly stated policy. The policy should read:

Codes 88184 and 88185 must be billed with modifier -TC (technical component).

Providers should note that code 88145 is not a Medi-Cal benefit.

  California — Medi-Cal

Medi-Cal Update:  GM Contents.

Payment Reduction Reversed for Select Genetic Disease Lab Panels

The 5 percent payment reduction that was applied to the following genetic disease tests for dates of service on January 01, 2006 through March 03, 2006 is being reversed.

Providers need take no action. Claims for these codes for the affected dates of service will be reprocessed for correct payment.

  California — Medi-Cal

Medi-Cal Update:  Bulletin 386 (PDF).

In accordance with the 2006 updates to the Current Procedural Terminology – 4th Edition (CPT-4 code book), the provider manual has been updated to reflect changes in reporting for codes used to bill for Pap smear tests.

This section contains information to assist providers in billing for pathology procedures related to cytopathology services.

Pap Smear Tests
Taking a Papanicolaou (Pap) smear sample is considered part of a pelvic examination and is not separately reimbursable. The Pap smear test is reimbursable only to the provider who performs and reads the Pap smear and issues the written report. These tests include up to three smears for Pap tests for cancer screening and/or a qualitative report on the patient's level of estrogen.

Modifiers -TC, -ZS and -26
Providers may use modifiers -TC or -ZS to bill cervical or vaginal Pap smear results. When a smear is billed with modifier -26, it is reimbursable only to a hospital pathologist whose service is not covered by the hospital.

Clinical or Hospital laboratory
Pap smears examined in a clinical or hospital can be Laboratory reimbursed with modifier -ZS only if both the professional and technical components are performed in the laboratory.

Billing Restrictions
CPT-4 codes 88142, 88143, 88147, 88148, 88150, 88152, 88153, 88154, 88164, 88165, 88166 or 88167, 88174 or 88175 may be used to bill cervical or vaginal Pap smear tests and to report physician interpretation services. Reimbursement is limited to one Pap smear in 30 days when billed by any provider, for the same recipient.

Physicians, hospital outpatient departments and clinical laboratories may bill using codes 88147 and 88148.

Note: Clinical laboratories must use technical component modifier -TC when billing for these services.

CPT-4 code 88141 (cytopathology, cervical or vaginal [any reporting system]; requiring interpretation by physician) is used to report smears that require separate interpretation by a physician. Providers must bill CPT-4 code 88141 with modifier -26. This code is not to be used to bill routine quality control measures used in the supervision of technicians.

Note: Same day billing is allowed for code 88141 and a Pap smear code (88142, 88143, 88147, 88148, 88150, 88152, 88153, 88154, 88164, 88165, 88166 or 88167, 88174 and 88175) when a smear requiring separate physician interpretation is detected and documented on the claim. Same day billing for these codes is not allowed for the routine quality control re-examination of slides made by a technical supervisor or pathologist.

Optical Imaging Evaluations
CPT-4 code 88152 (cytopathology, slides, cervical or vaginal; with manual screening and computer- assisted rescreening under physician supervision) describes an improved technology using optical imaging equipment to routinely evaluate negative smears. This code is not to be used to bill routine quality control measures used in the supervision of technicians.

Hormonal Evaluation
CPT-4 code 88155 is reimbursable for Pap smears performed for a definitive hormonal evaluation, and may be billed in conjunction with codes 88141 - 88143, 88147, 88148, 88150, 88152 - 88154 or 88164 - 88167, 88174 and 88175. Medical justification must be documented in the Remarks area/Reserved For Local Use field (Box 19) of the claim or on an attachment. Code 88155 is reimbursable once in 30 days when billed by the same provider for the same recipient.

Fine Needle Aspirates
CPT-4 codes 88172 and 88173 are used for billing the cytopathology evaluations of fine needle aspirates. Code 88199 or other “By Report” codes for this procedure will be denied. Providers must use the appropriate modifier when billing these procedures.

  Illinois — Medicaid

Bulletin:  August 29, 2006 (PDF).

The American College of Obstetrics and Gynecology (ACOG) recommends pregnant women be screened for HIV as part of the routine battery of prenatal blood tests. ACOG further recommends that an offer of HIV testing be repeated in the third trimester to women in areas with high HIV prevalence, women known to be at high risk for HIV infection, and women who declined testing earlier in pregnancy. The rapid HIV test can be used to determine the HIV status of the mother. The woman’s written informed consent must be obtained before administering an HIV test.

Reimbursement for Rapid HIV Testing
HFS covers Rapid HIV testing. Reimbursement for the test, which consists of a finger stick and mouth swab, is $11.60. The procedure code for billing is 86701 with the QW modifier