Outpatient Services
• Clinics and Hospitals
Outpatient and Medical Crossover Claims Billing Update
October 2008 • Bulletin 409
Contents
Medi-Cal Training Seminars Outpatient and Medical Crossover
Claims Billing Update ... 1 Reimbursement for Second
Assistant Surgeon Update ... 1 Physician Assistant
Services Expanded ... 2 Abatacept Injection Policy Update ... 2 Secretin Injection Update ... 2 Pediatric Combination Vaccine
New Benefit ... 2 Rabies Biologics Update ... 3 Bortezomib (Velcade)
Policy Update ... 3 Expanded Telemedicine Benefits ... 3 Billing Code Changes for
Chemotherapy Drugs Irinotecan and Leucovorin
Calcium ... 4 HCPCS code J9310
Requirements Update ... 4 Cataract Postoperative Care
Billing Guidelines ... 5 “One Time Drug Fill” Language
Removed from Part 2 Manual ... 5 Family PACT Provider Orientation
and Update Sessions ... 5 National Drug Code (NDC)
Reporting Requirements ... 7 CCS Physician Services Supplemental
Rate Increase for Physician-Only Service Components ... 11 Maximum Reimbursement Rates
for Pathology Codes ... 13 Utilization of Zolpidem in
New Start Recipients ... 13
Variances in Medicare/Medi-Cal billing policy may cause hospital outpatient or medical crossover claims for the same procedure code to deny as duplicate billings. When a hospital or physician bills the professional component of a pathology or radiology service with modifier 26, and bills the technical component for the same code separately without modifier TC (blank modifier), one of the claims will cross over to Medi-Cal and deny as a duplicate. A blank modifier triggers a payment for the global service (both the professional and technical components) in the Medi-Cal system. To prevent a denial, providers must bill Medicare for the technical component with modifier TC. Providers with denied technical component claims for duplicate services (Remittance Advice Details [RAD] code 010) may resubmit the outpatient crossover claim by adding modifier TC to the Medicare Remittance Advice (RA). Until a system solution can be implemented, there is no similar workaround for denied professional component claims billed by different providers. When a system solution is implemented, EDS, an HP company, will automatically reprocess affected claims for payment.
Reimbursement for Second Assistant Surgeon Update
Effective for dates of service on or after November 1, 2008, reimbursement for a second assistant surgeon is allowed for the following CPT-4 codes.
Cardiopulmonary Surgery 32852, 32854 33031, 33120, 33251, 33259, 33261, 33305, 33315, 33321, 33322, 33332, 33335, 33400, 33403, 33405, 33406, 33410 – 33412, 33415 – 33417, 33422, 33425 – 33427, 33430, 33460, 33465, 33468, 33474, 33476, 33478, 33496, 33500, 33504, 33510 – 33514, 33516 – 33519, 33521 – 33523, 33530, 33533 – 33536, 33542, 33545, 33572, 33641, 33645, 33647, 33660, 33665, 33670, 33675 – 33677, 33681, 33684, 33688, 33692, 33694, 33702, 33710, 33720, 33724, 33726, 33730, 33736, 33774 – 33781, 33786, 33788, 33814, 33840, 33845, 33851 – 33853, 33860, 33861 33863, 33864, 33870, 33875, 33877, 33910, 33916, 33922, 33925, 33926, 33945, 35081, 35082, 35091, 35092, 35103, 35211, 35241, 35271, 35331, 35361, 35363, 35526, 35531, 35548, 35549, 35551, 35560, 35626, 35631, 35646, 35651
Urinary System Surgery
51590, 51595 – 51597, 59510, 59525
Providers must document in the Reserved for Local Use field (Box 19) of the claim that the services were rendered by more than one assistant surgeon for the same surgery on the same date.
Physician Assistant Services Expanded
Effective retroactively for dates of service on or after January 1, 2008, the number of physician assistants (PAs) that may be supervised by a physician and surgeon is expanded to four. In addition, all services performed by a PA within his or her scope of practice may be reimbursed when the service would be a covered benefit if performed by a physician and surgeon.
The supervising physician and surgeon shall review, countersign and date a sample consisting of, at minimum, 5 percent of the medical records of patients treated by the PA functioning under the protocols within 30 days of the date of treatment by the PA. If the PA ordered Schedule II drugs, the supervising physician and surgeon must review, countersign and date the records within seven days. When billing for assistant surgeon services performed by the PA, providers should bill with modifier 99 (multiple modifiers). Modifier 99 = modifier 80 (assistant surgeon) + modifier AN (PA). Modifier AS is no longer an approved modifier for these services.
Timeliness will be overridden until April 1, 2009.
This information is reflected on manual replacement pages modif app 4 (Part 2), non ph 1, 2, 3 and 5 (Part 2) and psych 1 (Part 2).
Abatacept Injection Policy Update
Effective for dates of service on or after November 1, 2008, policy for HCPCS code J0129 (injection, abatacept, 10 mg) is revised. Documentation is required when requesting a Treatment Authorization
Request (TAR) or Service Authorization Request (SAR) if the patient had an inadequate response
after treatment with one of the following:
• One or more non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), or • At least one or more TNF antagonists (infliximab, etanercept or adalimumab), or the
interleukin-1 receptor antagonist anakinra
There is no age restriction or diagnosis restriction for abatacept. In addition, either of the following dosing schedules may be used:
• Abatacept 10 mg/kg with a maximum dose of 1,000 mg, or • According to body weight
This information is reflected on manual replacement pages inject 45 and 46 (Part 2).
Secretin Injection Update
Effective for dates of service on or after November 1, 2008, HCPCS code J2850 (injection, secretin, synthetic, human, 1 mcg) is updated to remove the Treatment Authorization Request (TAR) requirement, as well as the diagnosis restrictions.
This information is reflected on manual replacement page inject 57 (Part 2).
Pediatric Combination Vaccine a New Benefit
Effective retroactively to August 15, 2008, the Pentacel pediatric combination vaccine, CPT-4 code 90698 (diphtheria, tetanus toxoids, acellular pertussis vaccine, haemophilus influenza Type B, and poliovirus vaccine, inactivated [DTaP-Hib-IPV] for intramuscular use) is a new Vaccines For Children (VFC) program benefit for infants and children as an alternative to pre-existing vaccines already approved for pediatric immunization.
Vaccine (continued)
The Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to haemophilus influenza Type B. Pentacel is contraindicated in children with histories of severe allergic reaction (for example, anaphylaxis) to a previous dose of the Pentacel vaccine or its ingredients, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine and hemophilic influenza Type B vaccine.
Pentacel is billed with CPT-4 code 90698 and modifier SL (state-supplied vaccine). It is reimbursable for children 6 months through 4 years of age.
This information is reflected on manual replacement pages inject 23 (Part 2), inject vacc 1 (Part 2) and vaccine 3 and 9 (Part 2).
Rabies Biologics Update
Effective for dates of service on or after November 1, 2008, rabies biologics for the pre-exposure and post-exposure prophylaxis of rabies are updated as follows:
• CPT-4 codes 90375 (rabies immune globulin [RIg], human, for intramuscular use) and 90376 (rabies immune globulin, heat-treated [RIg-HT], human, for intramuscular and/or subcutaneous use) are Medi-Cal benefits for the post-exposure prophylaxis of rabies and must be billed with diagnosis code V01.5.
• CPT-4 code 90675 (rabies vaccine, for intramuscular use) no longer requires an invoice, but must still be billed with the SK modifier.
• CPT-4 code 90676 (rabies vaccine, for intradermal use) is no longer a Medi-Cal benefit.
This information is reflected on manual replacement pages inject 2 and 5 (Part 2), inject vacc 1 (Part 2), modif used 4 (Part 2) and non ph 11 (Part 2).
Bortezomib (Velcade®) Policy Update
Effective for dates of service on or after November 1, 2008, diagnosis restrictions for bortezomib (Velcade) are updated as follows:
• Bortezomib (HCPCS code J9041 [injection, bortezomib, 0.1 mg]) must be billed with ICD-9-CM codes 203.00 – 203.02 (multiple myeloma) and 200.40 – 200.48 (mantle cell lymphoma).
• Bortezomib is no longer reimbursable when billed in conjunction with ICD-9-CM code 202.80 (other lymphomas).
Dosage limitations for bortezomib are also updated.
The updated information is reflected on manual replacement pages chemo 26 and 27 (Part 2).
Expanded Telemedicine Benefits
Effective retroactively to July 1, 2008, telemedicine services have been expanded. An originating site facility fee is reimbursable when billed with code Q3014 (telehealth originating site facility fee). Transmission costs incurred from providing telemedicine services via audio/video communication is reimbursable when billed with code T1014 (telehealth transmission, per minute, professional services bill separately). The timeliness for these claims will be overridden through April 16, 2009.
Telemedicine (continued)
Restrictions for billing transmission costs are as follows:
HCPCS Code Transmission Site Frequency Limit Rate
Q3014 Originating site Once per day $22.94
T1014 Originating site and distant site
Maximum of 90 minutes per day (1 unit = 1 minute)
24 cents per minut
Transmission Sites
These services provide expanded coverage to improve access to specialty care for Medi-Cal recipients where the transmission site of a practitioner and patient differs from the site of a consulting practitioner. Interactive telemedicine consists of audio/video equipment with live or “real time” transmission between a practitioner and patient at the “originating site” and a consulting practitioner at a “distant site.”
An “originating site” is the location of an eligible recipient at the time service is furnished via telecommunications. Originating sites authorized by law are as follows:
• Offices of physicians or practitioners • Critical access hospitals
• Rural health clinics
• Federally Qualified Health Center
A “distant site” is the location from where a physician or practitioner provides professional services via telecommunications.
This information is reflected on manual replacement pages medne tele 1 thru 4 and 8 (Part 2).
Billing Code Changes for Chemotherapy Drugs Irinotecan and Leucovorin Calcium Effective for dates of service on or after November 1, 2008, chemotherapy drugs irinotecan and leucovorin calcium will be billed with national HCPCS Level II codes, as follows.
New
HCPCS Code Description Previous Code/Strength
J0640 Calcium leucovorin, 50 mg X6446/10 mg/ml
J9206 Irinotecan, 20 mg X7636/100 mg
There is no change in policy. Claims billed for HCPCS codes X6446 and X7636 for dates of service on or after November 1, 2008 will be denied.
This information is reflected on manual replacement pages chemo 3 and 14 (Part 2) and inject list 9 and 10 (Part 2).
HCPCS code J9310 Requirements Update
Effective for dates of service on or after November 1, 2008, the policy and restrictions for HCPCS code J9310 (rituximab [Rituxan®]), when used for rheumatoid arthritis and other inflammatory polyarthropathies, have been updated. Rituximab does not require a Treatment Authorization Request (TAR) and the age restriction no longer applies. However, providers must document the requirements in the Remarks field (Box 80) of the UB-04 claim form or the Reserved for Local Use field (Box 19) of the CMS-1500 claim form, or on an attachment to the claim, all of the following:
• A diagnosis of ICD-9-CM code 714.0 – 714.9
• Documentation that the patient has had an inadequate response after treatment with one or more non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs) and at least one or more tumor necrosis factor (TNF) antagonists (infliximab, etanercept or adalimumab) or the interleukin-1 receptor antagonist anakinra.
Note: Claims without the required documentation listed above will be denied.
Cataract Postoperative Care Billing Guidelines
Medi-Cal considers CPT-4 code 92015 (determination of refractive state) as typical postoperative follow-up care included in the surgical package for cataract extraction surgeries. Therefore, effective November 1, 2008, code 92015 is not reimbursable when billed in conjunction with or within the 90-day post follow-up period of CPT-4 codes 66840, 66850, 66852, 66920, 66930, 66940 and 66982 – 66985.
This information is reflected on manual replacement page ophthal 7 (Part 2).
“One Time Drug Fill” Language Removed from Part 2 Manual
Effective immediately, all language regarding percent variance applicability to one-time drug fills is being removed from Part 2 manual sections related to Treatment Authorization Requests (TARs) for Pharmacy.
This information has been removed from manual replacement page tar comp 9 (Part 2).
Provider Orientation and Update Session
Medi-Cal providers seeking enrollment in the Family PACT (Planning, Access, Care and Treatment) Program are required to attend a Provider Orientation and Update Session. Dates for an upcoming session is listed below. Registration opens at 8 a.m., with Session I beginning promptly at 8:30 a.m.
Individual and group providers wishing to enroll must send a physician-owner to the session. Nonprofit and government clinics seeking to enroll must send their medical director, physician or nurse practitioner who is responsible for oversight of medical services rendered at the service site where the provider wants to enroll.
Office staff members, such as clinic managers, billing supervisors and client eligibility enrollment supervisors, are encouraged to attend. However, these staff members are not eligible to receive a
Certificate of Attendance. Enrolled clinicians and staff members are encouraged to attend to remain
current with program policies and services. New Session Format
Family PACT has created a new session format, which offers an option for currently enrolled providers and staff to attend only the afternoon update session, along with either the clinical session or the billing and coding session.
Session I – Overview of the Family PACT Program:
Start Time 8:30 a.m. to 2 p.m.
Instructions Attendance at this presentation is mandatory for clinician providers wishing to enroll in Family PACT and is recommended for other staff who are new to the program or need a refresher.
Note: The following afternoon sessions will run concurrently from 2 p.m. to 4 p.m.: Session II – Clinical Practice Alerts:
Start Time 2 p.m. to 4 p.m.
Instructions Clinicians in attendance who wish to become Family PACT providers must also attend this session. Free continuing education (CE) credit is available for Session II. Providers must bring their medical license numbers if requesting CE credit; a continuing education request form will be available during onsite registration. Other interested clinical staff members are welcome to attend and may request free CE credit for this session.
Provider Orientation (continued)
Session III – Tips for Successful Family PACT Administration:
Start Time 2 p.m. to 4 p.m.
Instructions Administrators and billers interested in Family PACT program administration and
billing information may attend.
Please note the upcoming Provider Orientation and Update Session below. San Diego
December 4, 2008 8:30 a.m. – 4 p.m. The Westgate Hotel 1055 2nd Avenue San Diego, CA 92101 (619) 557-3713
For a map and directions to these locations, providers can go to the Family PACT Web site (www.familypact.org) and click “Providers” at the top of the home page, then “Provider Training” in the menu on the left-hand side, then “Orientation Sessions,” and finally, click “Directions and Map of Location” for the appropriate session location.
Registration
To register for an orientation and update session, providers should:
• Go to the Family PACT Web site (www.familypact.org) and click “Providers” at the top of the home page, then “Provider Training” and “Click here to find out about upcoming Orientation Sessions.” Identify the session you wish to attend and click “Registration” next to the appropriate date and location.
• Print a copy of the registration form.
Fill out the form and fax it to the Office of Family Planning, ATTN: Darleen Kinner, at (916) 650-0468.
If you do not have Internet access, you may request the registration form by calling 1-877-FAMPACT (1-877-326-7228). Providers must supply the following when registering:
• Name of the Medi-Cal provider or facility • National Provider Identifier (NPI) • Contact telephone number
• Anticipated number of people attending Check-In
Check-in begins at 8 a.m. All orientation sessions start promptly at 8:30 a.m. and end by 4 p.m. At the session, providers must present the following:
• NPI
• Medical license number • Photo identification
Note: Individuals representing a clinic or physician group should use the clinic or group NPI, not an individual NPI or license number.
Certificate of Attendance
Upon completion of the orientation session, each prospective new Family PACT medical provider will receive a Certificate of Attendance. Providers should include the original copy of the Certificate
of Attendance when submitting the Family PACT application and agreement forms (available at the
session) to Family PACT Provider Enrollment. Providers arriving late or leaving early will not receive a Certificate of Attendance. Currently enrolled Family PACT providers do not receive a certificate.
Provider Orientation (continued)
Contact Information
For more information about the Family PACT Program, please call 1-877-FAMPACT (1-877-326-7228) or visit the Family PACT Web site at www.familypact.org.
The Family PACT Program was established in January 1997 to expand access to comprehensive family planning services for low-income California residents.
National Drug Code (NDC) Reporting Requirements
Beginning September 1, 2008, providers are encouraged to begin using the National Drug Code (NDC) for physician-administered drugs, in conjunction with the customary Healthcare Common Procedure Coding System (HCPCS) Level I, II or III code, on all Medi-Cal claims.
• Claims submitted for dates of service from September 1, 2008 through March 31, 2009 without an NDC will not be denied.
• Claims with dates of service on or after April 1, 2009 that do not meet the NDC reporting requirements to include a valid NDC paired with a HCPCS code, will result in claims being denied.
The Deficit Reduction Act of 2005 (DRA) requires all state Medicaid agencies to collect rebates from drug manufacturers for physician-administered or dispensed drugs. Only those products manufactured by companies participating in the federal Medicaid rebate program are reimbursable under Medi-Cal. A list of manufacturers participating in the rebate program, which changes periodically, is available in the Part 2 manual section Drugs: Contract Drugs List Part 5 – Authorized
Manufacturer Labeler Codes.
National Drug Code Description
The NDC is a number that identifies a specific drug. The NDC number consists of 11 digits in a 5-4-2 format. NDCs printed on packages often have fewer than 11 digits, with hyphens (-) separating the number into three segments. A complete 11-digit number must have five digits in the first segment, four digits in the second segment, and two digits in the last segment. The first five digits of an NDC identify the manufacturer of the drug and are assigned by the Food and Drug Administration (FDA). The remaining digits are assigned by the manufacturer and identify the specific product and package size. Leading zeros are added wherever they are needed to complete a segment with the correct number of digits.
Example: 5-4-2 Format
Package Number Zero Fill 11-digit NDC 1234-1234-12 (01234-1234-12) 01234123412 12345-123-12 (12345-0123-12) 12345012312 2-22-2 (00002-0022-02) 00002002202
The NDC is found on the drug container (vial, bottle or tube). The NDC submitted to Medi-Cal must be the actual NDC number on the package or container from which the medication was administered. Providers should not bill for one manufacturer’s product and dispense another. It is considered to be a fraudulent billing practice to bill using an NDC other than the one administered.
Physician-Administered Drugs
A physician-administered drug includes any covered outpatient drug provided or administered to a recipient, which is billed by a provider other than a pharmacy. Such providers would include, but not be limited to, physician offices, clinics and hospitals. A covered outpatient drug is broadly defined as a drug that may be dispensed only upon prescription and is approved for safety and effectiveness as a prescription drug under the Federal Food, Drug and Cosmetic Act. Physician-administered drugs are not restricted to injectable drugs only. Physician-administered drugs include any drug regardless of the method of administration.
NDC (continued)
Drug Identification Guidelines
There are three items to look for that will identify whether or not a product is a drug:
1. NDC – The vial or box that held the drug would have an NDC on it that will be used for claims.
2. Lot and Expiration Date – All drugs have both a lot number and expiration date on the vial or box.
3. Legend – This refers to statements such as, “Caution: Federal law prohibits dispensing without prescription,” “Rx only” or similar words. All prescription drugs have these types of
statements. Claims Processing
Claims will continue to be priced based on the HCPCS code, with the NDC and corresponding units being used for drug rebate processing. Medicare primary claims will also require NDCs with HCPCS codes.
Quantity Reporting
Reporting instructions apply to both paper claims and electronic transactions. At this time, Medi-Cal will use only the HCPCS quantities/units for payment and rebate purposes. Sometimes it may be necessary for providers to bill multiple NDCs for a single procedure code. This may happen when two different strengths of the same drug are needed in order to administer the appropriate dose. This will also be necessary when multiple vials of the same drug are used to administer the appropriate dose, and the vials are manufactured by different manufacturers. When a provider uses more than one NDC for a drug, the provider must include all NDCs on the claim. The quantity for each NDC must be reported separately by repeating the HCPCS code.
PAPER CLAIMS CMS-1500 Claim Form
For paper claims submitted on the CMS-1500 claim form, the NDC is reported in the shaded area of Box 24A.
• Box 24A (shaded area) – This area will have a combination of two values entered: Bytes 1 and 2 will include the Product ID Qualifier. This qualifier identifies the type of number that is being provided, which is an NDC, with a qualifier of ‘N4’. Bytes 3 – 21 will consist of the entry of the appropriate number for the qualifier entered in the first two digits. The length of this additional information will vary depending on the type of number being provided (as identified by the previous 2-byte Product ID Qualifier).
Example: N4 as the Product ID Qualifier, followed by the 11-digit NDC – N412345678901
• Box 24D – The HCPCS code will continue to be entered in 24D, with the charges in Box 24F and units in Box 24G.
NDC (continued)
• Box 24D (shaded area) – In this area, enter the NDC unit of measure (two positions) immediately followed by the numeric quantity administered to the patient, which is a full 10-digit number. The 10 digits consist of seven digits for the whole number, followed by the three-digit decimal portion of the number.
Note: The quantity field should be entered from left to right. Do not enter a decimal. Valid Unit of Measurement Qualifiers are the following:
F2 = International Unit GR = Gram
ML = Milliliter UN = Unit
Examples: UN0000012000 for a quantity of 12 units
ML0000124540 for a quantity of 124.54 milliliters UB-04 Claim Form
For paper claims submitted on the UB-04 claim form, the NDC is reported in the Description field (Box 43).
• Box 43 – Enter the two-digit Product ID Qualifier ‘N4’ in the first two positions, immediately followed by the 11-digit NDC (no hyphens). Directly following the last digit of the NDC (no delimiter), enter the two-digit Unit of Measurement Qualifier as noted above. Immediately following the Unit of Measurement Qualifier, enter the nine-digit quantity. The nine digits consist of six digits for the whole number, followed by the three-digit decimal portion of the number.
Note: The quantity field should be entered from left to right; do not enter a decimal. The Description field on the UB-04 form is 24 characters in length.
Example: Unit quantity of 30 for NDC 12345678901: N412345678901UN000030000 • Box 44 – Using the HCPCS/RATE/HIPPS Code field, enter the five-character HCPCS code. • Box 46 – Using the Serv. Units field, enter the corresponding service units for the HCPCS
reported. Direct Data Entry
The Point of Service (POS) device and Internet Professional Claim Submission (IPCS) system have not been updated yet.
NDC (continued)
Direct Data Entry (continued)
In the interim, providers using these means of claims submission should continue to provide the HCPCS code only. These applications will be remediated and HCPCS/NDC pairing will be required beginning with dates of service on April 1, 2009 and after. Please watch for more detailed information in future Medi-Cal Updates.
HIPAA 837 Institutional Transactions
For HIPAA-compliant ASC X12N 837 Institutional electronic claim transactions, the HCPCS code is reported in Loop ID 2400.
Loop 2400:
Field SV201 – Enter the national code. Field SV202-1 – Enter qualifier ‘HC’. Field SV202-2 – Enter the HCPCS code.
Field SV202-3 – Enter the UD modifier if you obtained the drug under the 340B program. Field SV204 – Enter qualifier ‘UN’.
Field SV205 – Enter the quantity.
Example: SV2*250*HC*Jxxxx**UN*1~ Loop 2410:
Field LIN02 – Enter qualifier ‘N4’.
Field LIN03 – Enter NDC without hyphens. Example: LIN**N4*12345678901~ Field CTP04 – Enter quantity.
Field CTP05 – Enter unit of measure. Example: CTP****2*ML~
For more detailed information, please refer to the 837 Transaction Companion Guides billing instructions for electronic claim transactions on the Medi-Cal Web site (www.medi-cal.ca.gov). From the home page, click the “References” tab, then “HIPAA Update, ” and finally the “ASC X12N Version 4010A1 Companion Guides and NCPDP Technical Specifications” link.
SECTION 340B OF THE PUBLIC HEALTH SERVICE ACT Background Information
The 340B Drug Pricing Program resulted from enactment of Public Law 102-585, the Veterans Health Care Act of 1992, which is codified as Section 340B of the Public Health Service Act. Section 340B limits the cost of covered outpatient drugs to certain federal grantees, federally qualified health center look-alikes and qualified disproportionate share hospitals. Significant savings on pharmaceuticals may be seen by those entities that participate in this program.
Section 340B of the Public Health Service Act provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services, in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed the average manufacturer price (“AMP”) decreased by a rebate percentage. Section 340B also requires eligible entities to charge the Medicaid program no more than the actual acquisition cost of the drug plus the state allowed dispensing/administration fee, and to require the state Medicaid program to exclude these claims from the collection of rebates.
340B Outpatient Drugs – UD Modifier
In order for providers to identify 340B outpatient drugs that have been dispensed, the National Medicaid EDI Healthcare (NMEH) has recommended use of the ‘UD’ modifier. This will allow Medicaid to identify those claims that are from 340B entities and exclude them from the rebate collection process. The ‘UD’ modifier should be billed on the CMS-1500 & 837 Professional and the
UB-04 & 837 Institutional claim forms, associated with the applicable HCPCS code and NDC, to
properly identify 340B drugs. The UD modifier is to be used only in this circumstance. All non-340B drugs are billed using the applicable HCPCS and NDC pair without a modifier.
CCS Physician Services Supplemental Rate Increase for Physician-Only Service Components
Effective for dates of service on or after October 27, 2008, the Department of Health Care Services (DHCS) has determined the following:
• For procedure codes that contain both a technical and a professional (physician)
component, the California Children’s Services (CCS) physician services supplemental rate increase should only be applied to the professional component.
• For procedure codes that do not constitute a physician service, the supplemental rate increase should not be applied.
Effective for dates of service on or after October 27, 2008, application of the supplemental rate increase will be restricted as follows:
• Procedure codes billed with surgical supply modifiers ZM and ZN will not receive the CCS increase, as these two modifiers are reimbursed for supply items and do not constitute a physician service.
• Specific codes in the following table have no physician/professional component and will not receive the CCS increase.
Procedure code Description
77401 Radiation, treatment delivery, superficial and/or ortho voltage
77402 Radiation, treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks; up to 5 MeV
77403 Radiation, treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks; 6 – 10 MeV
77404 Radiation, treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks; 11 – 19 MeV
77406 Radiation, treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks; 20 MeV or greater
77407 Radiation, treatment delivery, two separate treatment areas, three or more ports on a single treatment area, use of multiple blocks; up to 5 MeV 77408 Radiation, treatment delivery, two separate treatment areas, three or more
ports on a single treatment area, use of multiple blocks; 6 – 10 MeV 77409 Radiation, treatment delivery, two separate treatment areas, three or more
ports on a single treatment area, use of multiple blocks; 11 – 19 MeV 77411 Radiation, treatment delivery, two separate treatment areas, three or more
ports on a single treatment area, use of multiple blocks; 20 MeV or greater 77412 Radiation treatment delivery, three or more separate treatment areas, custom
blocking, targential ports, wedges, rotational beam, compensators, electron beam; up to 5 MeV
77413 Radiation treatment delivery, three or more separate treatment areas, custom blocking, targential ports, wedges, rotational beam, compensators, electron beam; 6 – 10 MeV
77414 Radiation treatment delivery, three or more separate treatment areas, custom blocking, targential ports, wedges, rotational beam, compensators, electron beam; 11 – 19 MeV
77416 Radiation treatment delivery, three or more separate treatment areas, custom blocking, targential ports, wedges, rotational beam, compensators, electron beam; 20 MeV or greater
Rate Increase (continued)
Procedure code Description
77520 Proton treatment delivery; simple, without compensation 77522 Proton treatment delivery; simple, with compensation 77523 Proton treatment delivery; intermediate
77525 Proton treatment delivery; complex
81025 Urine pregnancy test, by visual color comparison methods 83013 Helicobacter pylori; breath test analysis for urease activity,
non-radioactive isotope
88184 Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; first marker
88185 Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; each additional marker
88400 Bilirubin, total, transcutaneous
89055 Leukocyte assessment, fecal, qualitative or semiquantitative
Note: Procedure codes 70000 – 89999 that have a professional component (physician) will receive the CCS supplemental increase only for the professional (physician) component. Procedure codes billed with the modifiers in the following table will be priced as specified in the table:
Modifier CCS Increase Description
26 – Professional component No impact: Claims will receive the full CCS supplemental increase.
22 – Unusual Service
Claims will receive the CCS supplemental increase on the physician/professional component of the procedure only.
25 – Significantly separately identifiable E&M – same provider and date of service 59 – Separately identifiable service 78 – Return to operating room 79 – Unrelated procedure or service 90 – Reference (outside) Laboratory ET – Emergency Services
QW – CLIA waived test SA – Nurse Practitioner
SC – Medically necessary service ZS – Professional and Technical Component
TC – Technical component Claims will not receive the CCS supplemental increase.
Maximum Reimbursement Rates for Pathology Codes
Effective for dates of service on or after October 27, 2008, Medi-Cal policy indicates that laboratory services are paid at the least amount of the following:
• The amount billed
• The charge to the general public • Medicare’s maximum allowance • Medi-Cal’s maximum allowance
In some instances, California Children’s Services (CCS) and outpatient hospital claims for certain laboratory services receive a payment increase resulting in a rate that exceeds the Medicare maximum allowable amount. Current payments are limited to the Medicare maximum amount regardless of the modifier billed. For dates of service on or after October 27, 2008, modifiers will be used when determining the appropriate Medicare maximum allowable amount for the procedure and/or modifier combination billed. Reimbursement for the professional component of such services will continue to receive the CCS supplemental increase when appropriate. Claims that are not split-billed will not be impacted.
Utilization of Zolpidem in New Start Recipients
D
RUG U SER
EVIEWE ducational I nformation
6/01/07 5/31/08
3/01/07
90-Day Washout Zolpidem New Start
Continuous Eligibility
3/01/07 5/31/08
Insomnia is one of the most common complaints brought to a physician’s office affecting approximately one-third of the adult population in the United States.1 While there are a number of pharmacologic treatment options available, many are associated with undesirable adverse effects such as daytime drowsiness, memory and psychomotor impairment, orthostatic hypotension, and blurred vision.2 Tolerance and dependency may also occur with prolonged use of some agents.3 Zolpidem immediate release (IR) (Ambien®) and zolpidem extended-release (ER) (Ambien CR®) are among the most utilized drugs for the management of insomnia. Their documented efficacy with minimal residual effects, decreased risk of tolerance, and lowered potential for abuse are reasons for their popularity.4 Pharmacy claims data for Medi-Cal fee-for-service (FFS) showed that since January 2006, the total number of claims for zolpidem IR and zolpidem ER combined averaged approximately 18,000 per month. To understand this utilization better, a retrospective analysis was conducted to determine utilization characteristics of zolpidem among FFS recipients who were new starts on zolpidem IR or zolpidem ER between June 1, 2007 and May 31, 2008.
We identified 19,488 FFS recipients who met the above criteria and included them in our analysis.
Table 1 presents our recipients by gender and age group. Many studies have found insomnia to be
more prevalent among females.5 It was therefore not unusual to see two-thirds of the recipients were females. This increased prevalence may also be due to there being more female (60 percent) than male recipients in the general FFS population. Insomnia also has greater prevalence among the elderly population.6 Sixty-six percent of the recipients were between 40 – 64 years of age and 11 percent were 65+. The greater majority of recipients in the 40 – 64 age group may in part be due to the greater number of recipients belonging to that age group in the general FFS population to begin with. The 65+ age group may be under-represented in the analysis since the majority of patients who are 65+ should have their prescription drugs covered under Medicare Part D. Significant changes in zolpidem utilization under FFS occurred as a result of the implementation of Medicare Part D. In 2005, there were 137,605 zolpidem recipients with a total of 564,129 claims for zolpidem. In 2006 the number of zolpidem recipients decreased by over 50 percent to 68,238 and a total of 223,881 zolpidem claims.
Zolpidem (continued) 12,887 (66.1%) Female 19,488 (100%) Total 2,176 (11.2%) 65+ 12,885 (66.1%) 40 - 64 4,011 (20.6%) 19 -39 52 (0.27%) 0 -12 364 (1.9%) 13 - 18 19,448 (100.0%) Total Age Group 6,601 (33.9%) Male Gender
Table 1: Zolpidem Recipient Population by Gender and Age Group
19,488 (100.0 %) Total 1,089 (5.6%) • 706 (64.8 %) : IR Æ ER • 381 (35%): ER Æ IR • 2 (0.2%): IR + ER Both 4,000 (20.5 %) Extended-Release 14,399 (73.9 %) Immediate-Release
Table 2: Recipient Population by Formulation of Zolpidem Prescription
During the 12-month period of our analysis, almost 75 percent of the recipients were on the IR formulation of zolpidem and 20 percent were on the ER formulation (Table 2). The remaining 5 percent of the recipients had at least one claim for each formulation. Of the recipients that had been on both, 65 percent started on the IR formulation before switching to the ER formulation. There were two recipients who had a claim for both formulations on the same day. Approximately half of those recipients who had switched from one formulation to another, made their switch within 90 days of their initial zolpidem prescription.
Extended-Release Immediate-Release 12.5 mg 6.25 mg 10 mg 5 mg Extended-Release Immediate-Release
Table 3b: Total Zolpidem Claims by Strength Within Each Formulation
11,413 (78.6%) 3,110 (21.4%)
30,011 (71.1%) 12,217 (28.9%)
56,751 (100.0%) Table 3a: Total Zolpidem Claims by Strength
56,751 (100.0%) 14,523 (25.6%) 42,228 (74.4%) 14,523 (100.0%) 42,228 (100.0%) 11,413 (20.1%) 3,110 (5.5%) 30,011 (52.9%) 12,217 (21.5%) 12.5 mg 6.25 mg 10 mg 5 mg Extended-release Immediate-release
Table 3: Total Zolpidem Claims by Formulation
Between June 1, 2007 and May 31, 2008, there were a total of 56,751 claims for zolpidem (Table 3). Almost 75 percent of these claims were for zolpidem IR. More than 50 percent of all zolpidem claims (Table 3a) and 71 percent of claims for the IR formulation (Table 3b) were for the 10 mg strength. Zolpidem IR is indicated for the “short-term treatment of insomnia characterized by difficulties with sleep onset”; whereas zolpidem ER is indicated for “insomnia characterized by difficulties with sleep onset and/or sleep maintenance.”7 - 8 The greater utilization of zolpidem IR over zolpidem ER may indicate the majority of our recipients may have problems with initiating sleep rather than maintaining sleep, or both. The recommended dose of zolpidem IR and zolpidem ER for adults is 10 mg and 12.5 mg, respectively.7 - 8 Patients who are elderly or debilitated may be especially sensitive to the effects of zolpidem.7 - 8 Patients who have hepatic insufficiency do not clear zolpidem as rapidly as normal patients.7 - 8 Therefore, the recommended zolpidem dose for both patient populations is 5 mg for zolpidem IR and 6.25 mg for zolpidem ER.7 - 8 Since the majority of our elderly patients 65+ would have their prescription drug coverage under Medicare Part D and because the majority of our recipient population instead were adults 40 – 64 years of age, it was not unusual to see a larger number of claims for the 10 mg and 12.5 mg strengths.
Zolpidem (continued)
C
Ninety-four percent of all claims for zolpidem were for a 30-day supply. The cumulative days supply for all these claims during the 12-month period was generated for each recipient.
Chart 1 presents the percentage of recipients within each cumulative days supply range. The majority
of our recipients had a cumulative days supply between 1 – 90 days and 12 percent had more than 180 days supply. Graph 1 depicts the number of recipients within each cumulative days supply range. The greater majority of our recipients had a cumulative days supply of 1 – 30 days. Although few, some of our recipients had more than 360 days supply.
hart 1: Percentage of Recipients Within Each Cumulative Days Supply Range
1 - 90 Days: 71% 91 - 180 D 17% 180+ Days: 12% ays:
Graph 1 : Number of Recipients Within Each Cumulative Days Supply Range
0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 1 - 30 31 - 60 61 - 90 91 - 120 121 -150 151 -180 181 -210 211 -240 241 -270 271 -300 301 -330 331 -360 360+ Days Supply Nu m b e r o f R e ci pi en ts Antiepileptics •Phenytoin •Lamotrigine Antihypertensives •Clonidine •Propranolol Decongestants •Pseudoephedrine •Phenylephrine SSRIs •Fluoxetine •Sertraline Levodopa Theophylline MAOIs
Caffeine and Caffeine-Containing Products Quinidine Oral Contraceptives CNS Stimulants •Methylphenidate •amphetamine •Dextroamphetamine •Modafinil Bupropion Thyroid Hormones Steroids
Table 6: Drugs with Insomnia as a Potential Side Effect*
*List of drugs is not all-inclusive. Adapted from references 3 and 9.
Some commonly used drugs are known to disrupt normal sleep (Table 6). The claims history of our recipient population was searched for these drugs. Fifty-three percent of our recipients had at least one claim for one of the drugs listed. Each patient’s response to a drug is generally individualized, but should always be considered as possible contributors when evaluating patients experiencing insomnia.9
From the results of our analysis, a few areas of utilization stood out:
• More than 50 percent of our recipients had a claim for a drug that may have contributed to their insomnia or can counter the effects of zolpidem. If a primary root cause for a patient’s insomnia exists, whether it is a drug or medical condition, it is important that it be identified and appropriately addressed to avoid treating insomnia as merely a symptom of that cause. • The large majority of our recipients had a cumulative days supply of 1 – 30. The shorter
duration of use in these recipients may indicate the acute nature of their insomnia or it may suggest the possible ineffectiveness of zolpidem, requiring a switch to an alternate
medication. A further analysis of this group of recipients found that 39 percent had a claim for a possible sleep aid after they started taking zolpidem. However, since many drugs used to treat insomnia are also used for other medical conditions, we were unable to distinguish between a true switch versus a new treatment for a separate medical condition.
Zolpidem (continued)
• Twelve percent of our recipients were on zolpidem for more than 180 days. This demonstrates the possible chronic nature of insomnia. Patients often continue to report symptoms for many years after the onset of their insomnia.10 This results in patients taking sedative hypnotics for longer duration than is clinically evaluated and recommended.10 There is currently no published data supporting the efficacy and safety of zolpidem beyond six months.10
In comparison to many other insomnia treatment medications, zolpidem may have improved safety profiles. Despite this improvement, there are still risks associated with its use. A retrospective study by Wang PS, et al. found the use of zolpidem by individuals 65 years of age and older was associated with nearly twice the risk of hip fracture.11 There have been reports of hallucinations and sensory distortions even at therapeutic doses of zolpidem.2 Behaviors such as sleep-driving, preparing and eating food, making phone calls, or having sex have been reported with zolpidem with the patient having no recollection of the event(s).7 - 8 There were also reports in the media on the use of zolpidem possibly contributing to accidents on the road.12 Due to the lack of sufficient evidence supporting the efficacy and safety of long-term use of zolpidem beyond six months, the risks of adverse effects from the use of zolpidem may be under-recognized. It therefore remains essential that patients who receive treatment for insomnia with zolpidem are informed of the possible risks associated with it, in addition to receiving adequate follow-up care with their physicians to monitor for efficacy and safety.
References
1. American Academy of Sleep Medicine. Insomnia Fact Sheet.
http://www.aasmnet.org/resources/factsheets/insomnia.pdf. Accessed March 10, 2008. 2. Benca RM. Diagnosis and Treatment of Chronic Insomnia: A Review. Psychiatric Services.
2005; 56(3):332 – 343.
3. Ramakrishnan K and Scheid DC. Treatment Options for Insomnia. American Family Physician. 2007; 76: 517 – 526.
4. Jacobs GD, Pace-Schott EF, Stickgold R, Otto MW. Cognitive Behavior Therapy and
Pharmacotherapy for Insomnia. A Randomized Controlled Trial and Direct Comparison. Archives of Internal Medicine. 2004; 164: 1888 – 1896.
5. National Institutes of Health. NIH State-of-the-Science Conference on Manifestations and Management of Chronic Insomnia in Adults. National Institutes of Health
State-of-the-Science Conference Statement. June 13 – 15.
http://consensus.nih.gov/2005/2005InsomniaSOS026main.htm. Accessed January 17, 2008.
6. Thorpy MJ, Lieberman JA, Roth T, Owens GS. Sleep Disorders and Excessive Sleepiness: Impact on Quality of Life. Patient Identification. The American Journal of Managed Care.
2007; 13(6)(suppl):S132 – 139.
7. Ambien [Package Insert]. Sanofi-Aventis U.S. LLC, Bridgewater, NJ; February 2008. http://products.sanofi-aventis.us/ambien/ambien.html. Accessed June 23, 2008. 8. Ambien CR [Package Insert]. Sanofi-Aventis U.S. LLC, Bridgewater, NJ; January 2008.
http://products.sanofi-aventis.us/ambien_cr/ambiencr.html. Accessed June 23, 2008. 9. Reeder CE, Franklin M, Bramley TJ. Management and Treatment of Insomnia and Its Impact on
Today’s Managed Care. Current Lanscape of Insomnia in Managed Care. The American Journal
of Managed Care. 2007; 13(5)(suppl):S112 – 116.
10. Krystal AD, Erman M, Zammit GK, Soubrane C, Roth T, on behalf of the ZOLONG Study Group. Long-Term Efficacy and Safety of Zolpidem Extended-Release 12.5 mg,
Administered 3 to 7 Nights Per Week for 24 Weeks, in Patients With Chronic Primary Insomnia: A 6-Month, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study.
Sleep. 2008; 31(1):79 – 90.
11. Wang PS, Bohn RL, Glynn RJ, Mogun H, Avorn J. Zolpidem Use and Hip Fracture in Older People. Journal of the American Geriatric Society. 2001; 49:1685 -1690.
12.CBS Broadcasting. Concern Over Ambien and Driving. CBS Evening News.
March 8, 2006. http://www.cbsnews.com/stories/2006/03/09/eveningnews/main1384884.shtml. Accessed January 28, 2008.
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