Provider Update

Volume 18, Issue 2 

April/May 2001


Clarification of CPT Code 99431 Code Changes for All Hemodialysis Centers
Changes to OB Sonogram Policy Feeding Syringes (Code Z0477) Being Denied
DME Equipment Purchases Fee Adjustments for DME Codes
New Procedure Code for External Insulin Infusion Pumps Repair and Preventive Maintenance for Breathing Equipment
2000 Provider Workshop Questions Correction to 2000 Hospital Training Packets
LADUR: Treatment of HIV Infection: Part II Childhood Lead Poisoning Screening

Childhood Lead Poisoning Screening

Lead poisoning is the most common environmental health problem of children. In 1997 an estimated 890,000 children, age 1 through 5, were affected, even though this problem is entirely preventable.

In the past 30 years there has been a great deal of change in the approach to dealing with or reducing lead poisoning in the United States. The lowering of the level for defining lead elevation has been reduced from 60 ug/dl in 1960 to 30ug/dl in1978 and finally to 10 ug/dl in 1991. This reduction may be attributed to concern about the long term effects of lead on the nervous system. Developmental delay, behavioral problems, Attention Deficit Disorder (ADD), and speech and language problems have been reported even at these lower levels.

Children at highest risk for the development of lead toxicity are typically urban, low income, African-American children under 6 years of age who live in homes built before 1950 or homes remodeled before 1978. Children enrolled in Medicaid account for an estimated 60% of all children with elevated blood lead levels.

In 1999, the Government Accounting Office in Washington, DC, reported that despite a federal mandate that all Medicaid children be screened for lead toxicity, only 19% were screened. In Louisiana, an estimated 25% of all 1 and 2 year-old recipients were screened for lead in 1999.

The need for early detection and management is crucial in decreasing or actually preventing the effects of lead poisoning in children. Currently, the Medicaid KIDMED Program requires that screening for risk factors begin at 6 months of age. Unfortunately, not all Medicaid children are enrolled in the KIDMED program. All Medicaid children should have lead levels blood testing at 1 and 2 years of age. Children up to 6 years of age should have a blood lead test on their initial visit if a previously normal blood lead test is not documented.

Management strategies for children with elevated blood lead levels depends on the level. An elevated capillary test should be confirmed by a venous test. The classification of elevated blood levels and recommended management are outlined below. The most important thing in the management of lead toxicity is identification of the source of the lead and separating the child from the source. Referral to the Office of Public Health Sanitarian Services should be done for any child with one venous blood level of 20 ug/dl or greater or 2 levels between 15 and 19 ug/dl in a 3 month period.

Although the Centers for Disease Control (CDC) currently recommends screening of all children under 6 years of age, the Louisiana Childhood Lead Poisoning Prevention Program is establishing a population-based surveillance system to develop a plan for targeted screening. For more information, please contact Ms. Maria Lancaster at (504)599-0257 or Dr. Jean Takenaka at (504)568-5073. 

Personal Risk Questionnaire

The CDC recommends this basic questionnaire as a starting point:

1. Does your child live in or regularly visit a house that was built before 1950? This question could apply to a facility such as a home day-care center or the home of a babysitter or relative.

2. Does your child live in or regularly visit a house built before 1978 with recent or ongoing renovations or remodeling (within the last 6 months)?

3. Does your child have a sibling or playmate who has or did have lead poisoning?

Screen all children whose parent/guardian responds "yes" or "don't know" to any question.

CLASSIFICATION OF ELEVATED LEAD LEVELS AND RECOMMENDED MANAGEMENT

BLL (Ug/dL)

ACTION

< 10

Reassess or rescreen in 1 year. If child has not been screened, provide screening at

1 and 2 years of age. No additional action unless exposure sources change.

10 -14

Provide lead education to the family and provide follow-up testing in 3 months.

15 - 19

Provide lead education to the family and provide follow-up testing in 3 months, refer

to social services if necessary. If BLLs persist (i.e., 2 venous BLLs in this range at least 3 months apart) or worsen, proceed according to actions for BLLs 20-44.

20 - 44

Provide coordination of care (case management, clinical management, provide environmental investigation, and lead hazard control) with follow-up testing

monthly until environmental hazard has abated. Then quarterly or per physician�s order.

45 - 69

Within 48 hours, begin coordination of care (case management, clinical management, environmental investigation, and lead hazard control). Provide follow-up testing

monthly until environmental hazard has abated. Then quarterly or per physician�s orders.

>

70

Hospitalize child and begin medical treatment immediately. Begin coordination of care (case management, clinical management, environmental investigation, and lead hazard control) immediately and provide follow-up testing at 1 to 2 week intervals until environmental hazard has abated. Then at intervals ordered by the physician.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Clarification of CPT Code 99431 
RA Message 3/20/01 and 3/27/01 - FIMS # 6254

CPT code 99431 (History and examination of the normal newborn infant, etc.) must be performed within the first twenty-four hours of the child's life. If questions arise, please contact Tracey Zimmerman, Program Specialist, at 225-342-9319. Your cooperation is appreciated.


Code Changes for All Hemodialysis Centers

The following HCPCS Codes have been deleted effective August 15, 2000: 

J1760 Iron dextran 2 CC inj 
J1770 Iron dextran 5 CC inj 
J1780 Iron dextran 10 CC inj

Instead you are to use J1750 - Injection, Iron Dextran, 50 mg which replaces the above codes effective with date of service January 1, 2000. The reimbursement rate for this code is $14.32.


Changes to OB Sonogram Policy
RA Message 2/20/01 and 2/27/01 - FIMS # 6229

Effective with date of service March 1, 2001, Louisiana Medicaid's policy on reimbursement for obstetric sonograms is as follows:

One complete sonogram (either code 76805 or 76810) and two follow-up sonograms (either two 76815's, two 76816's or a combination of 76815 and 76816) will be reimbursed per recipient per 270 days per provider.

Third and succeeding claims for 76815 or 76816 with a diagnosis code of V22, V22.0, V22.1 or V22.2 from any provider will be denied.

Third and succeeding claims for 76815 or 76816 with a diagnosis code other than those above will be denied unless accompanied by dated notes which justify medical necessity, as these claims will pend for review.

Please call Kandis Whittington at 225-342-9490 or Tracey Zimmerman at 225-342-9319 if you have any questions.


Feeding Syringes (Code Z0477) Being Denied

Effective immediately, the Prior Authorization Unit of Unisys will begin denying prior authorization requests submitted for payment of 60cc feeding syringes (code Z0477) when they are requested in addition to enteral nutrition supply kits (codes B4034, B4035, & B4036). BHSF considers that enteral nutrition supply kits should normally contain these feeding syringes. Please note the following description of the enteral nutrition supply kits procedure codes and the minimal items that BHSF expects to be contained in each kit:

B4034 � Syringe-fed enteral nutrition supply kits 
              Feeding syringes 
              Tape/wipes

B4035 � Pump-fed enteral nutrition supply kits 
              Pump sets 
              Containers 
              Feeding syringes 
              Tape/wipes 

B4036 � Gravity-fed enteral nutrition supply kits 
               Gavage sets 
               Containers 
               Feeding syringes 
               Tape/wipes

Any questions concerning supply items expected to be covered as part of enteral nutrition supply kits should be directed to the Prior Authorization Unit of Unisys Corporation at phone #800-488-6334.


DME Equipment Purchases

The Durable Medical Equipment (DME) Program does not have any provision for the purchase of used or refurbished equipment. All fees established in the DME Program for purchase of DME items are based on prices for new equipment. 

Rentals that are authorized for short term needs may be either new or used equipment. Please note that in situations where rental equipment is later approved for purchase, that it must be replaced with new equipment. 


Fee Adjustments for DME Codes 

The adjusted maximum allowable fee for the DME procedure codes is as follows:

Procedure Code Description New Fee Effective Date
Z0629 Augmentative Communication Devices $7500 07/01/2000
Z4100 Low Profile Gastrostomy Kit  $ 192  11/01/2000
Z4101 Mickey Gastrostomy Kit w/Replacement Tube $ 114  11/01/2000

New Procedure Code for External Insulin Infusion Pumps

Code E0784 (authorization of external ambulatory insulin infusion pumps) has been made payable with a retroactive effective date of January 01, 2001. The Bureau has authorized reimbursement for external ambulatory infusion pumps for recipients who are EPSDT eligible (under age 21) and coverage is restricted to this age group. A maximum reimbursement fee of $3195.84 has been established for this purchase.


Repair and Preventive Maintenance for Breathing Equipment 
RA Message 2/6/01, 2/13/01, and 2/20/01 - FIMS # 6222

Medicaid does not provide for coverage in the DME Program for preventive maintenance of breathing equipment. When these services are done on a routine or periodic basis and involve filter replacements, fittings, minor adjustments, etc., we will consider these services to be preventive maintenance. 

DME providers of breathing equipment, such as oxygen concentrators, may request repairs for these equipment items when a recipient requests that the provider inspect and fix a broken or malfunctioning machine. To be considered as repairs, requests for prior authorization should document that the services were done as a result of a request by phone, or otherwise, from the recipient, to the provider, to come to the home to inspect and fix a broken or malfunctioning machine. Repairs needed on equipment brought to the provider by the recipient because of a broken or malfunctioning machine may also be considered when the provider documents that this was the situation. 

Documentation that repairs were requested by the recipient to fix broken or malfunctioning equipment may be noted on the delivery or invoice forms, or otherwise stated in writing to the Prior Authorization Unit.


2000 Provider Workshop Questions

The following information is the first half of the questions asked during the 2000 Provider Workshop sessions. A second series of questions will be included in the June/July 2001 Provider Update.

General Questions
1. Where is there a listing of Parish Office phone numbers?
On page 29 in the 2000 Basic Services Training Manual.

2. Adult recipients do not seem to be told by their local parish office that hospital emergency room visits are limited to 3 per calendar year. Can something be done about this?
The parish offices are not set up to conduct extensive recipient education on Medicaid benefits.

3. It seems like it is more difficult to get into Unisys to talk to someone lately.
We have had an increase in the number of people calling in to Provider Relations to check eligibility. Providers have told us that they would rather talk to a person than wait to use REVS. Unfortunately, this can tie up the lines for providers who have problems for which they need assistance. We are working to possibly change the REVS line to ring continuously while the system is busy as opposed to giving back a busy signal. This tends to encourage providers to hold on the line until the next phone line is free and REVS picks up the call.

4. If a presumptive eligible woman goes into labor or has a miscarriage and must be hospitalized, will Medicaid cover the inpatient charges?
No. Remember that presumptive eligibility only covers outpatient prenatal care including non-emergency transportation. Note that if the parish office changes the recipient's eligibility category from presumptive to regular Medicaid coverage then those inpatient services could be considered for payment.

5. If a recipient comes back with a retroactive Medicaid card, is the provider required to accept the card?
No. If the provider does not accept the retroactive card, then the parish office will require the provider to fill out the RRP-P form. The provider uses this form to indicate how much the recipient paid for the prior services so the State can issue a reimbursement to the recipient.

6. Does a recipient's 13-digit Medicaid number change if the CCN changes?
No. The 13-digit Medicaid number is a permanent number and will not change.

7. Are State Medicaid cards interchangeable? If a recipient has a Louisiana Medicaid card, can it be used in other states?
Louisiana Medicaid reimburses providers who are enrolled, some of whom are out-of-state providers. If a Louisiana Medicaid recipient uses the Louisiana Medicaid card for coverage with any other out-of-state provider that provider must enroll in order to be paid. They can enroll retroactively and the claim must be filed within one year of date of service. 

8. Can providers request a face-to-face visit when we have a problem?
Yes. Call Provider Relations at 1-800-473-2783 to request a field analyst visit.

9. For recipients in Medicare HMOs that receive pharmacy services, can we collect the Medicaid pharmacy co-payment?
Yes.

10. Do we have to accept the Medicaid card for prior services if the recipient did not inform us of their Medicaid coverage at the time of services?
No. If at the time of service the patient did not inform you of their Medicaid coverage, they were treated as a private pay patient, you do not have to go back and accept the Medicaid card for those prior services.

11. Who should be contacted if a provider is retiring?
The Unisys Provider Enrollment Unit must be notified of the retirement date. The phone number is (225)923-8510. CommunityCARE providers are required to notify the CommunityCARE Program at 1-800-609-3888 sixty (60) days prior to retirement.

12. If we bill Medicaid for accident-related services, do we have to use the annotation stamp on our documentation?
Yes. The annotation stamp should be on all accident-related documentation.

13. What if a Lock-In recipient tries to circumvent the program by going to the ER for services?
Report the recipient to the Lock-In Unit at the State so they can work with the recipient.

14. If our office accepts Medicaid, do we have to accept all Medicaid recipients?
No. You can determine your Medicaid caseload (Except Medicare/Medicaid recipients. By taking Medicare assignment, you must also accept Medicaid). However, once you accept the Medicaid card from the recipient, you cannot pick and choose which services you bill the Medicaid Program; you must bill all covered services to the Program.

15. If an attorney wants copies of itemized bills, etc. foraccident-related services, can the provider release this information to the attorney?
Yes. Please remember that all pertinent documents must have the Medicaid approved annotation stamp on them.

16. Does the State print a complete list of error codes for provider use?
No, however, providers receive an explanation of their error codes on their remittance advice.

17. If we do not want to continue accepting Medicaid from an existing patient, can we stop seeing the patient?
If a provider does not want to continue accepting Medicaid from an existing patient, they must notify the recipient before they want to stop seeing the patient. The patient can either continue seeing the provider as a private pay patient or they need to find another provider to accept their Medicaid card. You must notify the recipient first and give them ample time to find another provider that will accept their Medicaid card. Ample time is considered at least two (2) months prior to discontinuing services. CommunityCARE providers must call the CommunityCARE contractor to have that recipient unlinked from their caseload.

Case Management Questions
1. I have a three-month prior authorization (PA) in which the recipient had only one face-to-face contact during that time span. No other contacts or service logs were made for that recipient during that period. Despite this, my system generated claims for each of the three month-long periods. Is it permissible to bill for the entire quarter if the only contact during the quarter is a single face-to-face contact?
This question should be submitted in writing with a request for reply to the following address: Department of Health and Hospitals, Bureau of Community Supports and Services, Case Management Section, P. O. Box 91030, Baton Rouge, LA 70821-9030. 

2. When a recipient has private insurance and Medicaid, does Unisys forward a claim to the third-party carrier?
No, Unisys does not forward a claim to private insurance. However, case management services are exempt from TPL editing, so the case management provider may submit his claim to Unisys for processing without regard to the recipient's private insurance. 

3. Who is responsible for obtaining a completed 90-L-the case manager or the waiver service provider?
The case manager is ultimately responsible for obtaining the completed 90-L form; however, the process should be a cooperative effort between the case manager and the waiver service provider. The case manager should obtain the blank 90-L form, but the service provider is the one who can actually take the recipient to the physician's office so the physician can complete the 90-L.

4. We have determined that a waiver provider has overbilled based on what was approved via the MR/DD-14. We have advised the provider to submit voids to return payments in excess of what was approved. Can we obtain proof from Unisys that the voids were submitted by the provider?
Unisys cannot release that information to a provider other than the one submitting the voids. The waiver provider should be able to provide proof once the voids are processed and appear on a remittance advice. The remittance advice will show that the claims have been voided. This should be reported to the Bureau of Community Supports and Services Regional office and they will provide the necessary follow-up. 

5. Will the prior authorization process for waiver services prevent overbilling?
When prior authorization goes into effect, the waiver provider will be able to bill no more than the number of units approved on the prior authorization record. Therefore, waiver providers will not be able to bill more units than have been authorized. This is similar to the prior authorization process that affects case management services.

Claims Filing
1. Why does Medicaid not accept the Electronic Remittance Advice printout as proof of timely filing?
At this time we are not set up to verify the electronic remittance advice printouts. However, providers who get electronic RAs also get paper RAs, so a hardcopy is available for you to use as proof of timely filing. Some changes regarding the use of electronic RAs as proof of timely filing may be coming with HIPAA, but that would be in the future.

2. What do you do when you get a denial code 799 (No history record on file for this adjustment) when you know you put the right control number on your adjustment form?
Verify that you are using the correct control number and the correct RA date. If the control number has been verified it is possible that the recipient's record has been purged because the recipient had more than one recipient file. In that case, the adjustment should be sent to Unisys Provider Relations.

3. Do corrected claims need to be submitted to the same address as "problem" claims (Provider Relations Correspondence Unit)?
No, send your corrected claims straight to the P.O. Box designated for your claim type.

4. We have received a 110 MNP form from a recipient that has both Medicare and Medicaid. Do we have to accept this form and proceed billing Medicaid, or since the patient was Medicaid eligible at the time we accepted him as a patient, can we continue to bill the patient for the portion Medicare did not pay?
When the recipient has both Medicare and Medicaid, the provider, through Medicare assignment, must also bill Medicaid for co-insurance and deductible and cannot bill the patient.

5. If the patient liability amount for a Spend-Down eligible was only a portion of the Medicare co-insurance/deductible, is it guaranteed that Medicaid will pick up the remaining balance?
No, Medicaid is using a payment methodology to allow your total payment to be up to what is allowed by Medicaid for those services. If the payment from Medicare and the patient liability amount are more than Medicaid pays for that service, then your payment will be zero and you cannot bill the patient for the balance.

6. If there is an accident that occurs to a pregnant person under our care, can we choose (at the point of the accident) whether or not to accept Medicaid for the accident-related services?
Yes, the accident constitutes a separate situation from the pregnancy.

7. If you have a claim that denies, how long do you have to get the claim processed?
If the denial occurred within one year from the date of service, you have an additional year from the date of service in which to finally resolve the claims, a total of two (2) years except for KIDMED KM-3 claim forms. The initial timely filing guideline for KM-3 claims forms is 60 days from the date of service. If the denial occurs within that guideline, then an additional year is extended for payment consideration.

8. Can we bill the Medicaid recipient when we get 996 (Deductible and/or Co-insurance reduced the max allowable) denials?
No. Claims with the 996 code are considered APPROVED, not denied. The claim is considered to be paid (even if the payment is $0.00) and the recipient may not be billed for any balance.

9. Does Medicaid require the recipient to sign a waiver before the provider can bill the recipient for non-covered services?
No. Medicaid does ask that providers notify recipients ahead of time if they know Medicaid does not cover the service and that the recipient is responsible for payment.

10. If a claim pends for an error code that states, "Recycled recipient not on file," should we refile the claim?
No. You should wait until the claim actually is approved or denied. If your claim denied, then you would resubmit a corrected claim. 

11. If we file claims electronically, how can we sign each claim form?
The EMC certification letter that providers sign when submitting electronically acts as a signature for all claims for that EMC transmission.

12. What is the purpose of the CCN (Card Control Number) number when it cannot be used for billing claims?
The purpose of the CCN number is to prevent fraud and abuse and to be able to access a recipient's Medicaid eligibility.

13. We send our electronic claims to a clearinghouse on Thursday and sometimes on Wednesday, and the claims do not get processed for the next week. Why is that?
Since you are sending your claims to a clearinghouse, it would seem that the clearinghouse is not getting the electronic claims to us in a timely manner. The claims must get to Unisys from the clearinghouse by the EMC deadline (Thursdays at 10 a.m.) in order to be processed that same week.

14. When you say that the electronic filing certification letter must be submitted within 48 hours, does that include Saturday and Sunday?
No. The requirement is within 48 hours counting only business working days.

15. What is a claim in process?
It is a claim that is being reviewed for a particular reason and is pending in our system (e.g. medical review, timely filing, TPL, etc.). Claims pend for no more than 30 days. If your claim does pend longer, please report this to Provider Relations.

16. How do we know what to do about a claim in process?
Wait to see if the claim pays or denies after it comes out of processing. If the claim denies, you would need to make the appropriate corrections and resubmit the claim.

17. We occasionally get a denial for PA (Prior Authorization) not on file, but we know the PA number is good for our waiver services. Why does this occur?
It could be because you used an invalid PA number, or perhaps the PA number was not loaded to the PA files until after your claim was submitted, or it is possible that the PA number on your claim was incorrect or keyed incorrectly. Call Provider Relations at 1-800-473-2783 if you continue to have problems.

18. Is there a charge for provider histories?
There is no charge at this time for provider histories; however, this is not an efficient manner to reconcile accounts.

19. Why are claims denied even when the REVS system states the adult recipient has outpatient visits remaining?
Services limits are determined when claims hit the system. If other outpatient visit claims hit the system before your bill, then those service limits are used and hit against the total limit for the recipient.

20. Does Medicaid pend claims when there is a high dollar amount indicated on the claim?
Yes. Sometimes if the billed amount is extremely over the Medicaid approved amount for the service, the claim will pend and is reviewed to make sure there has not been a keying error. Conversely, if the billed amount is much lower than the approved amount, the claim will pend and is reviewed for the same reason.

21. Can you bill a recipient who is over 21 and has received concurrent care visits?
Yes. Medicaid does not cover concurrent care visits for adult patients. The patient can be billed for the denied visit. However, the State asks that providers coordinate care in these situations so as to reduce any unnecessary overlap of services.

22. For accident-related services, if we decide not to accept Medicaid and pursue a future settlement and the settlement does not come forth, can we go back and bill Medicaid for those accident-related services if we haven't accepted any money from another party?
Medicaid can be billed, keeping in mind timely filing deadlines, if money has not been received from any other party.

23. Can a Medicare/Medicaid recipient be billed for outpatient visits that exceed the Medicaid limits?
Yes. Services that exceed the Medicaid limits are considered non-covered and the recipient may be billed.

24. For non-covered Medicaid services, does the provider adjust off the balance or can they bill the recipient?
Either. The provider can write off the charge or bill the recipient.

25. If the provider does not accept the retroactive card for prior services, can the provider start accepting the Medicaid card for present and future services?
Yes. The provider can deny the card for retro services and start accepting the card for present and future services.

26. How do I get set up to bill electronic adjustments and voids?
Contact your software vendor and let them know you are interested in having these capabilities added. The software vendor may need to contact the Unisys EMC department for setup information. 

27. If we file electronically and get a claim denial, can the claim be resubmitted electronically?
Yes, as long as no claim attachments are needed for processing.

28. Can LTC providers bill electronically?
No, not at this time.

29. What if a patient has a TPL and the TPL is holding up payment and the claim is pushing the Medicaid timely filing deadlines? Should we go ahead and bill the claim to Medicaid to meet timely filing guidelines even though we do not have an EOB yet from the TPL?
Yes, submit the claim to Unisys to establish timely filing guidelines. Of course the claim should deny requesting the EOB, but once you have the EOB from the TPL, resubmit again to Unisys for payment consideration.

30. On the HCFA 1500, when the services billed are accident-related, should we check "yes" for accident related in block #10?
Yes, if the services are accident-related, mark the appropriate block in item #10 on the HCFA 1500.

CommunityCARE Questions
1. Our PCP office has several physicians in our group. Would CommunityCARE recipients be linked to the group or to an individual doctor?
Usually recipients are linked to the group by the group number.

2. When a CommunityCARE referral date expires, do we have to get another referral?
Yes, the PCP referral date must match the date of service.

3. How does a provider know that a recipient is a CommunityCARE recipient?
REVS and MEVS will tell you the recipient is in the CommunityCARE program and give you the PCP's name and phone number. 

4. Do routine eye exams require a PCP referral?
Routine, in office, non-surgical eye care procedures (eyeglasses, opthamology office visits, optometry office visits) are exempt services and do not require a referral.

5. Are adult recipients (21 and older) responsible for the bill for emergency room visits over the allowed 3 per year?
Yes, except for CommunityCARE recipients. Effective 7/1/2000, the three visit limit for emergency room visits is not applied to CommunityCARE recipients.

6. Are there any time restrictions for getting a PCP referral?
No, but you do have one year from the date of service to file the claim with Unisys. Referrals should be requested /issued prior to the service being provided or as soon as possible after the service is provided if a post-request is necessary.

7. Is there any situation in which a CommunityCARE recipient can pick a PCP from a non-CommunityCARE parish?
Yes. A CommunityCARE recipient can choose a PCP from a non-CommunityCARE parish if that parish is adjacent to the recipient's CommunityCARE parish and the provider is enrolled as a CommunityCARE provider.

8. What progress has the CommunityCARE program made? What are the future goals for the program?
The CommunityCARE program has been successful in improving the quality of and access to care for Medicaid recipient by providing a �medical home,� strengthening the patient/physician relationships by supporting use of community health care systems. CommunityCARE has also proven to be cost effective and DHH plans to expand the program statewide by 2002.

9. CommunityCARE recipients 21 or older now have unlimited ER visits?
Yes. Effective 7/1/00, the 3 visit limit for ER visits for 21 or older was abolished for CC recipients only.

10. Do lab services require a referral from the PCP?
Yes. If the ordering physician is not the PCP, the lab should obtain a copy of the ordering physician�s referral from the PCP (i.e. For emergency related services or inpatient related services the lab should obtain a copy of the hospital�s referral from the PCP).

11. Do you have to have a PCP referral for all specific diagnosis treatments?
Not necessarily. The diagnosis/condition on the referral should be consistent with the treatment provided. If a different diagnosis/condition is discovered the PCP should be consulted to determine if a new referral is needed.

12. If a specialist sees a recipient and determines the medical problem is unrelated to his specialty, and refers the recipient to another specialist, does the new specialist need to contact the PCP or does the first specialist pass his referral along to the new specialist?
The first specialist should advise the PCP of his findings and the PCP should write a new referral to the second specialist.

13. Our doctor reads diagnostic tests after the tests were performed by a hospital. The hospital gets a referral from the PCP only for the date of the test; however, the reading is done on the next day. Will the doctor who reads the test need to get a corrected referral to cover his date of service? And if so, who is responsible for getting the corrected referral from the PCP?
The doctor who reads the test does not need to obtain a corrected referral. The original referral may be used.

14. If you cannot get the CommunityCARE referral from the PCP when they said they would send one, can the recipient be billed?
No. The recipient should not be billed. Referrals should be obtained prior to providing services to CommunityCARE recipients. When referral must be issued retroactively, the PCP should issue them in 7-10 working days. Untimeliness in issuing referrals should be reported to your Unisys Provider Relations representative or the CommunityCARE program. 

15. If a recipient is changing their PCP, until the change is made in the system, what providers can use the referral that has the referral reason as "Change PCP?
"A PCP transfers overall care of that recipient when they give a �change PCP� referral. The new PCP becomes repsonsible for the recipients overall care. The new PCP should share a copy of the initial referral when a recipient needs speciality care, until the PCP change is entered in the system.

Eligibility Questions
1. If MEVS prints out an eligibility ticket, does that always mean the recipient is eligible?
No. The recipient's eligibility is not based on whether or not the MEVS machine prints out a ticket, but whether or not the recipient is certified Medicaid eligible for the service dates.

2. Do you have to have the card to use the MEVS system?
No. You can use the keypad to punch in the required information.

3. We have a situation where the birth date is wrong on the Medicaid file and the PR inquiry agent could not give us the birth date on the file. Shouldn't the inquiry agent give me the birth date on file for a recipient? 
No, the phone representatives can give out only segments of a patient's file information. The phone reps can only verify a patient's birth date.

4. Who completes the 110 MNP form? Who will send the 110 MNP form to the provider?
The recipient's local parish Medicaid office completes the form and will send it to the provider after they complete it.

5. Is there a presumptive eligibility for newborns?
No. The presumptive eligibility category is only for pregnant women. However, any child born to a Medicaid eligible mother can be automatically certified for Medicaid coverage. The hospital may initiate the Medicaid enrollment for the baby through the 152-N form or the mother can contact her local parish office to initiate the enrollment process.

6. Can the mother's ID number be used to bill for baby services before the baby is certified with his own Medicaid number?
No. The baby's charges must be billed with the baby's own number.

7. When a patient receives a paper eligibility form, does the paper form have the patient's 13-digit Medicaid number on it?
Yes.

8. Is the eligibility information on REVS and MEVS the same information?
Yes. Both the REVS and MEVS pull eligibility information from the same system.

9. Are prescription services covered under the LaCHIP program?
Yes, prescription services are covered for recipients who are covered under the LaCHIP program.

10. How long does it take to process a LaCHIP application? 
The state has up to 45 days to process the application. Depending upon the documentation supplied, it may take only three or four weeks. Coverage may be made retroactive up to three months prior to the application date provided the child meets all eligibility requirements during the three months. 

11. Does the applicant have to request retroactive coverage?
Yes, the applicant must request that retroactive coverage be granted. There is a section of the LaCHIP application that asks if the recipient has already incurred medical expenses.

12. What is the LaCHIP age limit?
LaCHIP eligibility terminates when the recipient reaches the age of 19.

13. Is there any way to identify a child as being a LaCHIP recipient by the Medicaid ID card?
The Medicaid card does not contain any information that identifies a Medicaid recipient as being covered through LaCHIP. 

14. If a pregnant woman's income status changes after she is deemed eligible, will she lose eligibility?
Pregnant women continue to be Medicaid eligible for pregnancy-related and postpartum services through the end of the month in which the 60 day period (beginning on the last day of pregnancy) ends.

15. What type of claim forms are used to file for LaCHIP services?
Providers use the same claim forms for LaCHIP recipients as for any other Medicaid recipients.

16. When is a recipient no longer eligible for EPSDT services?
Eligibility for EPSDT services ends on the date on which the recipient turns 21 years of age.

17. When we swipe the Medicaid ID card, we're told that the recipient has visits left. Then when we file our claim, it is denied because the patient has used all his office visits. Why does this happen?
The REVS and MEVS systems report office visits remaining based on paid claims rather than incurred services. If office visit claims are paid after eligibility is verified, the number of office visits remaining will be decreased by the number of office visits paid in that interim. 

18. We were told that we could use the MEVS printout from our swipe machine showing that there were office visits remaining to have our claim paid after it denied for error code 907 because the recipient used all his office visits. Is this true?
This is not true. The MEVS printout may be used in cases in which the recipient's eligibility is questioned for the date on which eligibility was verified by MEVS. There is a process in which the provider may request an extension of allowed office visits using the 158-A form. This process is discussed in the Medicaid provider manual for physicians. 

19. Can a pediatrician see a patient over age 21?
Medicaid policy does not prohibit a pediatrician from seeing a patient over age 21.

20. Is there a different reimbursement for KIDMED providers versus regular physicians for the immunization administration fee?
No, the reimbursement for immunization administration is the same for physicians and KIDMED providers.

21. Where do we obtain information on Medicaid providers in our area?
Providers may call Birch and Davis Health Management Corporation at (877) 455-9955 to obtain referral information on other providers who accept Medicaid.

22. Can a child who becomes sick in another state be covered by Louisiana Medicaid?
Yes, a Louisiana Medicaid-covered recipient who becomes ill in another state will still be covered by Louisiana Medicaid. However, the provider must enroll as a Louisiana Medicaid provider in order for the services to be payable. If the child has moved with intent to remain in the other state, then our case would need to be closed and that child would need to apply in the state of residence.

23. Is a 110-MNP spend-down form proof of retroactive eligibility?
No, it is not considered proof of retroactive eligibility. While spend-down eligibility is normally retroactive, the Form 18-SSI is the Medicaid eligibility form for this type of retroactive case and documents retroactive eligibility.

Home Health Questions
1. Does Medicaid cover aide-only visits for recipients with Medicare primary?
Yes, Medicaid does cover aide-only services. When billing for these services, the provider must indicate "aide-only" or "custodial care only" in the remarks section of the Unisys 101 home health claim form.

2. We are a home health agency and we have been doing ongoing physical therapy in the home for a recipient under the age of 21. With the new prior authorization (PA) guidelines for therapies in the home, do we now have to have all therapies prior authorized for dates of service on or after September 21, 2000-including the therapies we have obtained PA for as a multiple visit?
Effective with date of service September 21, 2000, all therapies must be prior authorized in order for the services to be reimbursed. 

3. Are speech therapy, physical therapy, and occupational therapy provided in the home by home health providers restricted to recipients under the age of 21?
No, these services are not restricted to recipients under age 21.

4. For physical therapies that now require PA, will the old physician orders be acceptable to send in for PA approval?
Yes, but the physician's prescription should be no more than six months old and should cover the dates to be prior authorized.

5. What is the turnaround time for PAs to be approved?
The Unisys Prior Authorization department has up to 25 days from receipt to process most prior authorization requests. However, most requests are processed in less time than this. 

Hospital Questions
1. Where on the UB-92 claim form does the attending provider number go and where does the CommunityCARE referral authorization number go?
On the UB-92, the attending provider number should be entered in form locator 82. The CommunityCARE referral authorization number should be entered in form locator 83A.

2. Is the prior authorization (PA) number always a nine-digit number?
Yes. The PA number for outpatient hospital services that require PA will always be a nine-digit number.

3. Is it necessary to indicate on the UB-92 form that the patient was transferred to our hospital from another hospital?
Yes. The receiving hospital indicates in form locator 84 ("remarks") of the UB-92 form that the patient is being transferred and indicates the name of the hospital from which the patient is being transferred.

4. When billing adjustments and voids electronically, are reason codes "00" and "99" accepted? We haven't been able to use those reason codes when billing electronically.
Until recently, not all reason codes could be submitted electronically. The electronic claim submission system has recently been updated. The acceptable EMC adjustment/void reason codes are as follows:
Reasons for Adjustment 
01 - Third Party Liability Recovery
02 - Provider Correction 
03 - Fiscal Intermediary Error
16 - SURS Recoupments 
88 - LTC PLI 148 Adjustment
90 - State Office Use Only - Recovery
99 - Other Adjustment Reason

Reasons for Void
10 - Claim Paid for Wrong Recipient
11 - Claim Paid for Wrong Provider
12 - Medicare Retro Recoupment
00 - Other Void Reason

5. Should we keep the prior year's Medicaid training packets?
Providers are encouraged to keep them for reference purposes.

6. We have a recipient with Medicare Part A only. We're billing Part B charges and keep getting 275 denials. Why?
Possibly there is a QMB (Qualified Medicare Beneficiary) indicator error in the recipient's Medicaid eligibility file, or in the Medicare file for Medicaid. Send your claim and EOMB to the Unisys Provider Relations Correspondence Unit at P. O. Box 91024, Baton Rouge, LA 70821, with a cover letter indicating the problem. The matter will be researched and you will receive a written response.

7. If a patient is an inpatient and receiving therapy, do these services require PA?
No, the therapy does not require PA if performed on an inpatient basis. Only outpatient therapy requires PA.

8. When billing revenue 490, do we have to include all other revenue codes?
Yes, you should include all charges associated with he ambulatory surgery, including all applicable revenue codes, in addition to the 490 revenue code. These HCPCS/CPT codes are needed to gather information for APGs.

9. In form locator 54 of the UB-92, is the dollar amount the amount paid by the TPL or is the contractual amount also included?
The amount entered in form locator 54 should include any contractual "write off" amount that is associated with the private insurance. 

10. Can CommunityCARE referrals be faxed?
Yes, a faxed copy of a referral can be used as long as the form is completed correctly and covers the dates of service in question.

11. When billing for an ambulatory surgery, should we no longer use HR 490 and list all charges separately?
Revenue code 490 should always be used when billing for ambulatory surgery procedures that are on the list of four surgical groupings. In addition, if the ICD-9 code on the UB-92 falls within the range of 01-86, you must use HR 490 on the claim form. You should also list all other revenue codes and CPT/HCPC codes that reflect the services provided. The latter information, (listing all other revenue codes) is for data collection purposes with DHH.

12. How do you determine the HCPC/CPT code to use with HR 490?
Providers should use the code that corresponds to the principal procedure performed.

13. Do we have to bill Medicare first even when we know the Medicaid patient's Part A is exhausted? Is pre-certification required when Part A is exhausted?
Providers must bill Part B charges to Medicare and enter the amount billed to Medicare Part B in form locator 54. Providers must also attach a copy of the Part B EOMB and documentation that Part A is exhausted. Pre-certification is required when Medicare Part A is exhausted.

14. What is error code 915 for?
Denial code 915 ("emergency outpatient visits exceed annual maximum (3)" ) is returned when a recipient 21 or older has used more than three emergency room (ER) visits per calendar year. These recipients can be billed for services in excess of the Medicaid established service limits.

15. Can we bill the recipient if the inpatient claim is denied for a pre-certification related reason?
This policy is covered in an article in the June/July 1999 provider newsletter. The recipient may not be billed if the pre-certification is denied because medical necessity is not met. Providers may not bill recipients simply because they were late in submitting the pre-certification information. The only situation in which the recipient may be billed is if the recipient presented himself as a private-pay patient, not informing the hospital of his Medicaid coverage. 

Mental Health Rehabilitation (MHR) Questions
1. What is the minimum age at which a recipient can receive MHR services?There is no set minimum age to receive MHR services. The child would have to meet the established criteria. 

2. Would there be a situation in which a MHR provider would have to submit a void?Such a situation could arise, though it should be rare. This is an example of such a situation: Data is entered into MHRSIS on the wrong recipient, the data allows a prior authorization to be issued, and charges are billed and paid on that recipient. The end result is that a claim has been paid for the wrong recipient, so that claim must be voided by the provider. Any errors in keying data should be voided or added in the MHRSIS system. If such errors result in less than 80% of the services delivered to the recipient or errors that result in the agency not meeting clinical manager requirements, the claim submitted to Unisys should be voided. 

PCA Waiver/EPSDT PCS Questions
1. Does Medicaid cover the pneumovax vaccine?
It is covered for recipients through age 17 if provided through VFC.

2. Is Z0010 a new PCA code?
No. Z0010 is the procedure code billed for recipients in the PCA waiver as opposed to PCA services rendered to recipients in the MR/DD waiver.

3. What is the point of entry for PCA waiver recipients?
The individual interested in applying for this waiver may contact BCSS at 1-800-660-0488 for more information. There is currently a waiting list.

4. Does the provider request the correct number of hours of PCS services to be authorized based on what he thinks he'll need to provide the care the recipient needs? 
Yes, and the provider bases this estimate on the daily schedule that is submitted with the PA request.

5. Does the old agency need to do anything when a recipient receiving PCS changes agencies?
Yes--the first agency must submit a reconsideration of the original prior authorization (PA) to Unisys to indicate the new ending date of service for that recipient. The new agency must request prior authorization by submitting a new PA 14 with documentation.

6. Is it acceptable to give blank copies of the 90-L form to physicians?
Providers may share blank copies of the 90-L form with physicians. 

7. What can be done if a PCS PA request is denied by Unisys?
Providers may submit up to 3 reconsiderations on a denied prior authorization.Providers should submit a copy of the denied request letter with "RECON" written at the top, all original documentation, and any additional documentation to support the request. It may be advantageous to call the Unisys Prior Authorization Unit to determine how best to resubmit the reconsideration (what type of additional medical documentation is needed or what was missing from the original request).

8. What is the benefit to our agency to provide PCS? 
It seems to us we are having to do work that the case management agency should do in preparing the paperwork.PCS is different from PCA services provided to MR/DD waiver recipients. With regard to PCS, the service provider is responsible for assembling required paperwork and obtaining prior authorization from Unisys-not the case manager. DHH is aware of provider concerns regarding reimbursement. 

9. Is there an EPSDT PCS manual available?
EPSDT PCS services are discussed in the EPSDT provider manual. Providers may request an EPSDT manual from the Unisys Provider Relations Telephone Inquiry Unit at (800) 473-2783. 

10. We were told that we cannot bill PCS services electronically. Is this true? 
No, providers may submit PCS electronically using the same claim format that is used to bill for PCA services. 

11. How often can we bill PCS services? 
PCS services may be billed in whatever intervals or cycles the provider chooses. However, all claims are subject to timely filing limitations.

12. If claims are denied because they contain an incorrect Medicaid ID number, should they be voided, or can they just be resubmitted?
Only paid claims can be adjusted or voided. Providers should resubmit denied claims after correcting any incorrect information. 

13. Is the PCS reimbursement rate included in the packet?
The reimbursement rate was not included in the training packet. PCS procedure code Z0200 is reimbursed at $4.05, which represents half an hour of service. 

14. Is one unit a half hour or a whole hour?
One unit is half an hour of service. Page 21 of the 2000 PCA Waiver/PCS training packet includes instructions for calculating the required number of units. 

15. Can a recipient receive more than four hours of PCS services per day?
PCS services are approved on a case by case basis. The physician consultant determines the number of hours to be approved based on the documentation submitted with the request. Documentation would have to support a request for more than four hours per day in order for such a request to be approved.

16. Is a requirement for PCS services that there is no one in the home able to care for the child? 
This is not a requirement for PCS services. The purpose of PCS services is to assist the caregiver of the child who qualifies for PCS. If a recipient is 15 years of age or older, the PCS worker may be left alone with the recipient while the caregiver is absent only if the recipient can direct his own care. 

Rural Health Clinic/Federally Qualified Health Center (RHC/FQHC) Questions
1. Are flu shots covered for adults? What is the payment for the flu shot?
Flu shots are only payable for recipients under 21. The payment for the flu shot is $9.45 to cover administration. Because the administration cost is covered, providers must not bill for an encounter and the flu shot on the same day of service.

2. How may we bill for flu vaccines for OB patients under age 21? 
As stated above, those under 21 may receive a flu shot but the cost is covered in the encounter and �Z� code procedure. 

3. Our RHC claims deny if we use our nurse practitioner's provider number as the attending number, but the regulations say that our nurse practitioner can perform these services. What is the problem?
DHH is aware of this problem and is working on a solution. At this time, in order to allow these claims to pay, use the provider number of the nurse provider's supervising physician as the attending provider number.

4. Who took Ruby Wilson's place as the cost reporting contact for RHCs and FQHCs?
Hayden Ellis is now the DHH cost reporting contact.

5. Can an RHC bill for vaccines provided through VFC if the RHC is not a KIDMED provider?
Yes, but because the administration costs are covered under the encounter code, encounters and vaccines are not payable on the same day of service.

6. What is the length of time it takes for a new provider to get a provider number?
As of March 2001, Unisys has taken over the DHH Provider Enrollment section. The new address is: Provider Enrollment, P.O. Box 80159, Baton Rouge, LA 70898-0159. The telephone number is (225)923-8510. The process should take 20-25 working days provided the application was complete. Incomplete applications will be returned to sender and not processed.

7. We're sending in immunizations on the KM-3 and they're not getting paid. Why not?
Immunizations may not be billed on the KM-3 claim form. They are to be billed only on the HCFA 1500 claim form.

8. How can we check status of KM-3 claims?
It is not possible to check the status of KM-3 claims. You must carefully monitor all documentation you receive regarding your KM-3 claims, including recycled claims listings, denied claim listings, and resubmittal turnaround documents. If your KM-3 claims have not appeared as paid or denied within about 3 weeks, resubmit them. 

9. We've always been told that we cannot adjust dates of service, but you're telling us that we can. Which is correct?
The date of service for claims filed on the HCFA-1500 claim form can be adjusted using the Unisys 213 form.

10. What constitutes proof of timely filing?
For claims other than KM-3 claims, a remittance advice page showing the claim was received by Unisys within one year of the date of service is the best proof of timely filing. For KM-3 claims, a number of forms that prove timely filing are discussed in the 2000 KIDMED training packet.

TPL Questions
1. Where do we put the TPL Carrier Code on the HCFA-1500?
On the HCFA-1500, the 6-digit carrier code goes in item 9a.

2. We have an updated address for a particular TPL carrier, but Provider Relations says the State files still have the old address. How can we have this corrected?
Please send the information to the Correspondence Unit, which will send the update to DHH, where the TPL address will be corrected.

3. We have a patient whose old TPL ended and who now has a new TPL. Unisys has both the old and new TPL on file for the recipient. We only have one EOB. How do we handle this?
If you can submit proof that the old TPL ended, and you have the EOB from the new TPL, submit all to the Correspondence Unit with a cover letter. We can send your claim through for processing and forward the request to DHH to end the first TPL and add the new insurance to the recipient's file.

4. Suppose you do not know the services rendered were related to an accident and you have already taken Medicaid payment. Once you find out the services are accident-related could you then void the Medicaid payment and bill the liability insurance?
You would need to contact the TPL Unit at DHH.

5. If a patient has both private insurance and Medicaid and the private carrier pays more than Medicaid, will Medicaid pay the difference?
No. If it is a covered service, Medicaid will approve the claims at zero.

6. We have a recipient whose Medicaid file indicates the recipient has a Medicare HMO, but the HMO carrier claims the patient is no longer covered. When we file to Medicaid, the claim denied because the HMO did not pay. How can we resolve this situation?
You can send the HMO's EOB that indicates no coverage to the Correspondence Unit with a cover letter explaining the problem. The State TPL Unit will follow up on the situation and update the patient's coverage so your claim(s) can process.

7. If a patient travels outside of their HMO network in order to be seen by our office, can we bill Medicaid?
If the HMO network denies the claim, then Medicaid will also deny the claim.

8. With TPL claims, once Medicaid pays, can you collect money from the recipient if there is a balance?
No. You cannot collect money from a Medicaid recipient unless it is a non-covered service.

9. A patient who has both Medicaid and a TPL, if Medicaid pays at zero ($0), can we bill the patient the balance?
No. If there were a balance it would be a write-off.

10. Can we collect co-pays from a Medicaid recipient whose TPL requires one?
No. The co-pay is built into our reimbursement and if there were a balance after Medicaid pays, it would be a write off. 

11. When a Medicare HMO is involved, can we collect the co-pay from the recipient?
No, you cannot collect a co-pay from a Medicaid eligible recipient even when the recipient has a Medicare HMO replacement plan.

12. How do you go about having the Medicaid TPL file for a recipient updated when they no longer have the insurance showing on the Medicaid file or if the recipient has coverage with another insurance not on file?
If you have an EOB from the insurance, send it along with the claim to the Provider Relations Correspondence Unit with a cover letter explaining the problem. If there is no EOB, send a letter to the Correspondence Unit explaining the problem and request that they forward the information to the State TPL Unit for review.

13. How long does it take to have the TPL file for a recipient updated?
 It takes about 7-14 days.

14. When dealing with accident-related services, what if the accident carrier (other payment resource) pays the provider even though we billed Medicaid and received payment?
Return the check to the accident carrier with a letter that states you billed and were paid by Medicaid and the money should go directly to the Medicaid Program.

15. Do REVS and MEVS identify the Medicare/Medicaid crossover recipient categories?Yes. The REVS system will give messages that identify the QMB category.
1. Pure QMB-the message will state the recipient is eligible for Medicare co-insurance and deductible only.
2. Dual QMB-the message will state the recipient is eligible for both Medicare co-insurance and deductible and Medicaid services.
3. Non-QMB- there will not be a specific message; however, REVS will indicate the recipient has Medicare in the TPL segment of the response. MEVS vendors identify these recipient categories through like messages on their response tapes.

16. If the recipient has Medicaid and other coverage with a PPO and the patient does not tell the provider they have a PPO, thus the provider does not get the services authorized with the PPO, can the patient be billed?
No. Eligibility inquiries prior to services will substantiate other resource. 

17. Can we collect a co-payment from a recipient who has an HMO and Medicaid?
No. If Medicaid is accepted, the patient cannot be billed the co-payment.

18. Can the provider go back and void Medicaid payment on accident-related services if the provider does not know at the time of service that the services are accident-related?
This procedure falls outside the normal process. The provider could appeal to the TPL Unit at the State, but it would be unusual not to know the services were accident related at the time of service.

19. How does a provider refund Medicaid when a recipient's TPL is found after Medicaid payment?
A provider can refund Medicaid through filing a void/adjustment claim or by sending the State a refund check.

20. Is there any difference between LaCHIP eligibility and regular Medicaid eligibility?
Louisiana implemented LaCHIP as a Medicaid expansion. LaCHIP is Medicaid. The only difference is that recipients eligible under Title XXI cannot have other creditable health insurance.


Correction to 2000 Hospital Training Packets

In the 2000 hospital training packet presented at the 2000 annual provider workshops, pages 32-39 include a list of ICD-9 procedures that fall into the surgical groupings considered under the outpatient surgical program. However, some codes were inadvertently omitted from the list. Please note that the following codes are also included in the outpatient surgical groupings:

ICD-9 Code

Description

Surgical Grouping

Fee

 

 

 

 

8782

GAS CONTRAST HYSTEROSALPINGOGRAM

2

$262.36

8783

OPAQUE DYE CONTRAST HYSTEROSALPINGOGRAM

2

$262.36

8926

GYNECOLOGICAL EXAMINATION

1

$220.39

9616

OTHER VAGINAL DILATION

1

$220.39

9622

DILATION OF RECTUM

1

$220.39

9623

DILATION OF ANAL SPHINCTER

1

$220.39

9625

THERAPEUTIC DISTENTION OF BLADDER

1

$220.39

9649

OTHER GENITOURINARY INSTILLATION

1

$220.39

9659

OTHER IRRIGATION OF WOUND

2

$262.36

9739

REMOVAL OF OTHER THERAPEUTIC DEVICE FROM   

2

$262.36

9802

REMOVAL OF INTRALUMINAL FOREIGN BODY FROM

1

$220.39

9803

REMOVAL OF INTRALUMINAL FOREIGN BODY FROM

1

$220.39

9804

REMOVAL OF INTRALUMINAL FOREIGN BODY FROM

1

$220.39

9805

REMOVAL OF INTRALUMINAL FOREIGN BODY FROM

1

$220.39

9814

REMOVAL OF INTRALUMINAL FOREIGN BODY FROM

1

$220.39

9815

REMOVAL OF INTRALUMINAL FOREIGN BODY FROM

1

$220.39

9821

REMOVAL OF SUPERFICIAL FOREIGN BODY FROM

1

$220.39

9822

REMOVAL OF OTHER FOREIGN BODY WITH INCISION

1

$220.39

9827

REMOVAL OF FOREIGN BODY WITHOUT INCISION

2

$262.36

9985

LOCALIZED HYPERTHERMIA

1

$220.39

9986

PLACED EXT. BONE STIM

1

$220.39

 

 

 

 


Louisiana Drug Utilization Review (LADUR) Education

Treatment of HIV Infection: An Overview - Part II

Nancy M. Toedter, Pharm.D.Associate Professor of Clinical Pharmacy Practice
The University of Louisiana at Monroe College of Pharmacy
Pharmacy Clinical Coordinato - Glenwood Regional Medical Center West Monroe, Louisiana

ISSUES:


� Management of HIV infection with highly active antiretroviral therapy (HAART) has dramatically reduced the progression of HIV to AIDS and has prolonged survival in HIV-infected patients.

� Therapy with a minimum of two nucleoside reverse transcriptase inhibitors (NRTIs) plus one to two protease inhibitors (PIs) or two NRTIs plus a non-nucleoside reverse transcriptase inhibitor (NNRTI) is considered the standard of care.

� These complex regimens are associated with serious drug-drug interactions, a multitude of adverse effects, and difficult dosing schedules, which make patient adherence a challenge.

Review of Part I 
The previous article (February 2001 issue) reviewed current epidemiological trends, goals of antiretroviral therapy, and the six nucleoside reverse transcriptase inhibitors (NRTIs) presently available. Since 1996, there has been a decline in both AIDS incidence and deaths, and AIDS prevalence continues to increase as the number of persons living with AIDS grows. The availability of potent antiretroviral therapies accounts for these favorable trends and as a result, has shifted HIV infection from being a uniformly progressive and fatal disease to being a chronic, manageable one. Blacks, Hispanics, and women continue to be disproportionately affected by the AIDS epidemic, and heterosexual HIV transmission continues to rise. 

Fifteen antiretroviral agents from three different classes are currently available in the U.S. for treating HIV infection (Table 1). These drug classes, which are designed to interrupt the life cycle of the virus at various stages, include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs). Highly active antiretroviral therapy (HAART) is considered the standard of care and generally consists of two NRTIs plus a PI or NNRTI. The goals of therapy include suppression of viral replication to undetectable levels while minimizing adverse effects and improving the patient's quality of life. 

There are currently six NRTIs and two combination nucleoside analog products (Combivir and Trizivir) approved for treating HIV infection. NRTIs, which must be phosphorylated to be active, work early in the viral replication cycle by inhibiting the reverse transcriptase enzyme. As a result, these agents slow or prevent HIV replication in newly infected cells. They are generally well tolerated and are associated with few drug interactions. However, it is important to note that in January 2001, the FDA and Bristol-Myers Squibb issued a warning to health care professionals that pregnant women may be at increased risk of liver damage and fatal lactic acidosis when prescribed the combination of stavudine and didanosine with other antiretroviral agents.38 

In this article, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, and treatment strategies will be discussed.

Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs) 
Three drugs are currently available in this class: nevirapine, delavirdine, and efavirenz. Similar to the nucleoside analogs, these drugs work early in the HIV life cycle and target the reverse transcriptase enzyme. However, NNRTIs differ from nucleoside analogs in several ways. They bind directly to reverse transcriptase and cause disruption of the enzyme's catalytic site; they act in a noncompetitive manner and do not compete with endogenous nucleoside triphosphates; they do not require cellular phosphorylation for activity, and they have no activity against HIV-2.22,39,40 Drug interactions are of concern with this class, since each NNRTI is a substrate of the cytochrome P450 enzyme system - nevirapine tends to induce cytochrome P450 metabolism; delavirdine tends to inhibit its metabolism; and efavirenz is both an enzyme inducer and inhibitor. Resistance and cross-resistance may develop rapidly with each NNRTI, and as a result, could eliminate this entire class in future regimens. Therefore, these drugs should only be used in potent combination regimens that maximally suppress viral replication, which usually consists of two NRTIs plus an NNRTI.30,39,40 When used in combination regimens, the NNRTIs can suppress viremia to undetectable levels; however, nevirapine and delavirdine have demonstrated a less durable effect on viral suppression than protease inhibitors and are generally considered less potent, so they are recommended as an alternative to PI-containing regimens. On the other hand, regimens containing efavirenz are considered as potent as PI-containing regimens and are therefore recommended as preferred initial regimens along with PIs. Advantages of these PI-sparing regimens include favorable adherence properties, less complicated dosing regimens, and avoiding the PI-related adverse effects.15,18,40 Rash, which can sometimes be severe, is the most common toxicity associated with this class of drugs.29,39 Average wholesale price (AWP) for these medications is approximately $300-$400 per month.23 

In 1996, nevirapine (Viramune) became the first NNRTI approved by the FDA. It has good CNS penetration, and although approved for twice-daily dosing (200 mg bid), its pharmacokinetic profile may permit once-daily administration (400 mg qd). Nevirapine is an enzyme inducer and has the potential to decrease serum concentrations of various medications, including PIs and oral contraceptives. Rash is the most common adverse effect associated with nevirapine, usually occurring within the first few weeks of treatment. To reduce the incidence of rash, nevirapine is dosed using a lead-in period. Other adverse effects include elevated transaminases, hepatitis, fever, nausea, and headache.29,30,39,40 In 1999, results from a clinical trial in central Africa (HIVNET 012 trial) showed that nevirapine reduced perinatal HIV transmission when given as a single 200-mg oral dose to an HIV-positive mother during labor, followed by a single oral 2-mg/kg dose administered to her newborn within seventy-two hours of birth. In contrast to a more complex zidovudine regimen, which is traditionally used to reduce perinatal transmission, nevirapine has favorable characteristics that make it attractive for widespread use in developing countries. These include a long half-life, potent antiviral activity, rapid onset of action, and reduced cost.41 Favorable data from the use of nevirapine in preventing perinatal HIV transmission have lead doctors to include this drug in postexposure prophylaxis (PEP) regimens following HIV exposures, although nevirapine is not indicated for this use. However, a report released by the CDC in January 2001 indicates that healthy people taking abbreviated four-week nevirapine regimens for PEP are at risk for serious adverse events, including severe hepatotoxicity and skin reactions. Serious toxicity has not been reported with nevirapine's single-dose regimen for preventing perinatal HIV transmission.41a 

Delavirdine (Rescriptor), the second NNRTI approved by the FDA, has several characteristics that make this drug less desirable than other NNRTIs. Delavirdine's shorter half-life necessitates dosing three times daily; it has a large pill burden requiring twelve tablets per day; it does not effectively penetrate into the CNS; it has multiple drug interactions, and there are no data with delavirdine showing a survival advantage or reduction in the incidence of AIDS-related complications. In contrast to nevirapine, which is an enzyme inducer, delavirdine is a P450 system enzyme inhibitor and, therefore, may increase serum concentrations of certain medications metabolized in the liver, resulting in potentially serious adverse effects. However, an advantage of enzyme inhibition is that delavirdine may raise serum concentrations of some protease inhibitors, thus allowing dosage reductions and simpler dosing schedules. Rash is the most common adverse effect with delavirdine, but it is generally less severe than that seen with nevirapine, and dose escalation to prevent rash is not helpful with delavirdine. Other adverse effects include headache, fatigue, nausea, diarrhea, and elevation of liver enzymes.29,30,40,42 

Efavirenz (Sustiva) is the newest NNRTI and the only one approved for once-daily dosing. When combined with two NRTIs, efavirenz appears to be as potent as PI-containing regimens in suppressing viral load and increasing CD4 counts.29 Therefore, the DHHS treatment guidelines recommend efavirenz, in a three-drug regimen, as a first-line treatment option and as a comparable PI alternative.15 It offers the advantages of easier dosing and better tolerability. Efavirenz is used in combination with NRTIs and/or PIs and may also prove useful in salvage regimens for patients not responding to standard treatment. The most common adverse effects include CNS symptoms (dizziness, somnolence, insomnia, confusion, impaired concentration, headache, vivid dreams) and rash, which is less common than that seen with other NNRTIs. These CNS side effects, which are due to the drug's good CNS penetration, generally begin during the first or second day of therapy and usually resolve after the first few weeks of dosing. Administering efavirenz in the evening (i.e., 12 hours before patients need to be alert) or at bedtime may improve the tolerability of these CNS symptoms. Efavirenz is both an inducer and inhibitor of the cytochrome P450 enzyme system; therefore, it is associated with several drug interactions, including some PIs. Lastly, efavirenz should be avoided during pregnancy because fetal abnormalities have been reported in monkeys.29,30,39,43

Protease Inhibitors (PIs) 
PIs have revolutionized the treatment of HIV infection. Introduced in late 1995, these agents, when used in combination regimens, have dramatically decreased AIDS-related opportunistic infections and deaths and prolonged survival in patients with HIV infection. The combination of a PI plus two NRTIs has achieved persistent viral suppression and a sustained increase in CD4+ T cell counts and is therefore recommended as a preferred initial antiretroviral regimen.15,18 Six PIs are currently approved in the U.S. and include two formulations of saquinavir (hard-gel and soft-gel capsules), ritonavir, indinavir, nelfinavir, amprenavir, and the new lopinavir/ritonavir fixed-dose combination product. 

Unlike nucleoside analogs and NNRTIs that work early in the HIV life cycle and prevent infection of new cells, PIs act in the later stages of the cycle and inhibit HIV replication in chronically infected cells (cells in which the HIV genetic material is integrated into the host cells' nucleus). PIs work by blocking the viral protease enzyme, which is responsible for cleaving large, precursor polyproteins into smaller, functional proteins. Inhibiting this enzyme results in the production of immature, noninfectious virions that are incapable of infecting new cells. Unfortunately, PIs do not prevent destruction of already infected cells. Since PIs target a different enzyme in the viral replication process, synergism occurs when these drugs are combined with reverse transcriptase inhibitors.44,45,46,47 

Although PIs are very effective, several issues are associated with their use. The high pill burden, administration instructions (e.g., take with food or on an empty stomach), and the frequency of dosing may affect compliance, and strict adherence is essential in order to maintain the drug's antiviral efficacy. Secondly, drug interactions are common with this medication class. All PIs are metabolized by hepatic cytochrome P450 enzymes, and these drugs are also inhibitors of cytochrome P450 activity. Ritonavir is the most potent, and saquinavir is the least potent P450 enzyme inhibitor. Thirdly, all PIs may be associated with the development of metabolic abnormalities, including hypertriglyceridemia, hypercholesterolemia, hyperglycemia, diabetes, insulin resistance, and lipodystrophies/abnormal body fat redistribution (buffalo hump). Resistance and cross-resistance are also major concerns with this medication class.44,45,46,47,48 Lastly, PIs are quite expensive, with AWP for these drugs ranging from approximately $500-$675 per month.23 

PIs may also be used together, known as dual PI therapy. These PI combinations take advantage of pharmacokinetic interactions to increase plasma concentrations of either of the two agents, thus allowing increased potency, dose reductions, reduced pill burdens, and simplified dosing regimens. The most common dual PI regimen is ritonavir plus saquinavir, with ritonavir being used because of its potent inhibition of the cytochrome P450 enzyme system.18,48,49 

Saquinavir was the first PI approved in 1995 for treatment of HIV infection. The original hard-gel capsule formulation (Invirase) had poor oral bioavailability (approximately 4%), resulting in low plasma drug levels. As a result, a reformulated soft-gel capsule (Fortovase) with enhanced oral bioavailability was introduced in 1997. Although more potent, the soft-gel saquinavir is associated with a large pill burden, requiring eighteen capsules per day. Both formulations remain available, but the hard-gel saquinavir should not be used as the sole PI in three-drug regimens. It should only be used when combined with ritonavir plus two NRTIs. Saquinavir is generally well tolerated, with mild gastrointestinal disturbances (nausea, diarrhea, abdominal discomfort) and rash occurring most frequently.15,18,44,48 

Ritonavir (Norvir) was the second PI approved by the FDA. Although extremely potent, ritonavir is poorly tolerated, resulting in a high rate of drug discontinuation. Adverse effects, which are particularly common during the first few weeks of therapy, include nausea, vomiting, diarrhea, anorexia, taste disturbances, asthenia, circumoral and peripheral paresthesias, and headache. These symptoms can be minimized by slowly escalating the dose. Another concern is ritonavir's extensive drug interaction profile. Of the PIs, it is the most potent inhibitor of the cytochrome P450 enzyme system and is known to interact with numerous medications. Because of its poor tolerability and many drug interactions, ritonavir as a sole PI in combination with nucleoside analogs is considered a second-line agent. Instead, it is mainly used in lower doses in dual PI combinations, whereby ritonavir acts as a pharmacokinetic enhancer to increase serum levels and decrease the dosing frequency of other PIs.15,29,30,44,48 

Indinavir (Crixivan) is also a potent PI, but it is better tolerated and has fewer drug interactions than ritonavir. Indinavir should be taken on an empty stomach for maximal absorption, but if gastrointestinal symptoms are intolerable, it can also be administered with a light, low-protein, low-fat meal. Because of its short half-life, indinavir should be dosed every eight hours around the clock. Twice-daily dosing is less effective and is not recommended unless combined with nelfinavir or ritonavir. Indinavir is generally well tolerated but has two notable side effects: nephrolithiasis and indirect hyperbilirubinemia. Kidney stones have been reported in approximately 5% of patients and are caused by crystallization of the drug in the kidney. To prevent stone formation, patients should drink at least 48 ounces (or 1.5 liters) of water throughout the day. Indinavir is a less potent inhibitor of the cytochrome P450 liver enzymes than ritonavir, so it is associated with fewer drug interactions.29,30,44,48,49 

Nelfinavir (Viracept) was the fourth PI to gain FDA approval. It is commonly used because it is very well tolerated and is easier to take than the other PIs. The most frequently reported adverse effect is mild to moderate diarrhea, which can be managed with over-the-counter antidiarrheal agents, such as loperamide or fiber supplements. Nelfinavir should be taken with food for better absorption and may be administered as 750 mg tid or 1250 mg bid, both regimens being equally effective. Nelfinavir is most similar to indinavir in its drug interaction profile.29,44,46 

Amprenavir (Agenerase) received FDA approval in 1999. It is formulated with a large amount of vitamin E to enhance absorption, so patients should be advised to avoid additional vitamin E supplements. Amprenavir's long half-life permits twice-daily dosing, but the high pill burden of sixteen capsules per day is a challenge for adherence. Amprenavir appears well tolerated, with the most common adverse effects being nausea, vomiting, diarrhea, oral paresthesias, headache, and rash. Rarely, severe or life-threatening rashes, including Stevens-Johnson syndrome, have occurred. Amprenavir is a sulfonamide; therefore, patients with sulfa allergies may be at increased risk for cross-sensitivity reactions. Similar to indinavir and nelfinavir but less than ritonavir, amprenavir also inhibits the cytochrome P450 hepatic system, resulting in several important drug interactions. Its resistance pattern remains to be determined, although cross-resistance to other PIs may be less likely.29,30,50,51 

Lopinavir/ritonavir (Kaletra) is the newest PI available for treating HIV infection. Approved in September 2000, it is the first fixed-dose dual PI combination product. This combination utilizes a pharmacokinetic interaction between the drugs to optimize treatment. Inhibition of cytochrome P450 metabolism through the use of low-dose ritonavir increases both the peak plasma concentration and the half-life of lopinavir. Therefore, lopinavir gives the combination product its antiviral activity, and ritonavir is used only as a "booster", inhibiting lopinavir's metabolism and causing increased and more sustained drug levels. This drug should be taken with food to enhance absorption, and the usual adult dose is three capsules or 5 mL of liquid (providing 400 mg lopinavir/100 mg ritonavir per dose) twice daily. Lopinavir/ritonavir is generally well tolerated, with the most common adverse effects including diarrhea, nausea, fatigue, headache, and asthenia. The PI class effects (hyperglycemia, hyperlipidemia, and abnormal fat distribution) have also been reported. The drug interaction profile of lopinavir/ritonavir is similar to that of the other PIs. A potential advantage of this dual PI combination is that it is active against some HIV strains resistant to other PIs and therefore may be useful for patients who have failed other regimens.52,53,54

Treatment Strategies 
The International AIDS Society-USA Panel (18) and the Department of Health and Human Services (DHHS) Panel on Clinical Practices for Treatment of HIV Infection (54) have developed treatment guidelines regarding antiretroviral therapy in adults. These guidelines are also periodically updated; IAS guidelines were last updated January 2000, and the new DHHS guidelines were recently released in February 2001. For the most part, both guidelines are similar in their recommendations. The preferred initial regimen should be potent, resulting in sustained suppression of viral load, preferably to undetectable levels, a sustained increase in CD4+ counts, and favorable clinical outcomes (i.e., reduced morbidity and mortality). Other considerations include the regimen's pill burden, dosing frequency, tolerability, food and drug interactions, adverse effects, and resistance profiles. Additionally, patients must be ready and willing to adhere to a complex drug regimen. This is important because the first HAART regimen is generally the most effective one and has the greatest chance for long-term success. A typical initial regimen would include at least 2 NRTIs plus one or two PIs or 2 NRTIs plus an NNRTI. Various combinations of agents are available, with each regimen having its own advantages and disadvantages.18,54

Conclusion
HIV infection is a complex disease, and its treatment remains a challenge to both patients and practitioners. Although the development of potent antiretroviral medications has revolutionized the care of HIV-infected patients, therapy is associated with many adverse effects and drug interactions as well as difficult dosing schedules. Therefore, medication adherence is often poor. However, a team approach to caring for these patients may help ensure success while improving the patient's quality of life.

Table 1. Currently Available Antiretroviral Agents

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Protease Inhibitors (PIs)

Zidovudine (Retrovir, AZT, ZDV)

Nevirapine (Viramune)

Saquinavir-HGC* (Invirase)

Didanosine (Videx, ddI)

Delavirdine (Rescriptor)

Saquinavir-SGC* (Fortovase)

Zalcitabine (Hivid, ddC)

Efavirenz (Sustiva)

Ritonavir (Norvir)

Stavudine (Zerit, d4T)

 

Indinavir (Crixivan)

Lamivudine (Epivir, 3TC)

 

Nelfinavir (Viracept)

Abacavir (Ziagen, ABC)

 

Amprenavir (Agenerase)

Combivir (AZT + 3TC)

 

Lopinavir/Ritonavir (Kaletra)

Trizivir (AZT + 3TC + ABC)

 

 

*There are two formulations of saquinavir: hard-gel capsule (HGC) and soft-gel capsule (SGC).

 

Table 2. Summary of Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Drug Name

Dosage Forms

Usual Adult Dose (oral)

Adverse Effects

Comments

 

Nevirapine

(Viramune)

200-mg tablet

50 mg/5 mL oral solution

200 mg qd x 14 days, then 200 mg bid

-Rash (most common)

-Elevated transaminases

-Hepatitis

-Nausea, fever, headache

-Take without regard to meals.

-May be dosed as 400 mg qd (non-FDA approved).

-Cytochrome P450 enzyme inducer.

-A single oral dose given to an HIV-positive mother and her newborn has been shown to reduce perinatal HIV transmission (HIVNET 012 trial).

 

Delavirdine

(Rescriptor)

100-, 200-mg tablets

400 mg tid

(100-mg tablets can be mixed with at least 3 oz of water to form slurry.)

-Rash (less severe than that seen with nevirapine)

-Elevated transaminases

-Headache, fatigue, nausea, diarrhea

 

-Take without regard to meals.

-Separate dosing from ddI or antacids by 1 hour.

-Cytochrome P450 enzyme inhibitor.

Efavirenz

(Sustiva)

50-, 100-, 200-mg capsules

600 mg qhs

-Rash (less common than that seen with other NNRTIs)

-CNS symptoms (dizziness, somnolence, insomnia, abnormal dreams, confusion, headache, impaired concentration)

-Elevated transaminases

 

-Appears to be as potent as a protease inhibitor (first-line therapy).

-Administer in the evening or at bedtime to minimize CNS symptoms.

-Take without regard to meals, but avoid high fat meals.

-Cytochrome P450 mixed enzyme inducer/inhibitor.

-Teratogenic in monkeys.

 

 

 

 

Table 3. Summary of Protease Inhibitors (PIs)

Drug Name

Dosage Forms

Usual Adult Dose (oral)

Adverse Effects

Comments

 

Saquinavir

(Invirase, SQV-HGC)

 

(Fortovase, SQV-SGC)

 

200-mg capsule (hard-gel)

 

200-mg capsule (soft-gel)

 

400 mg bid with ritonavir only

1200 mg tid

-GI intolerance (nausea, diarrhea, abdominal discomfort)

-Headache

(SE more common with Fortovase than Invirase.)

-Hyperglycemia, fat redistribution, abnormal lipids

-Invirase should not be the sole PI in a regimen.  It should only be used with ritonavir.

-Invirase can be taken without regard to meals.  Fortovase should be taken with a large meal.

-Least potent cytochrome P450 enzyme inhibitor.

-Refrigerate Fortovase capsules or store at room temp for up to 3 months.

Ritonavir

(Norvir)

100-mg capsule

600 mg/7.5 mL oral solution

600 mg bid

(400 mg bid when used with saquinavir)

-GI intolerance (common)

-Taste disturbances

-Asthenia, headache

-Circumoral and peripheral paresthesias

-Hyperglycemia, fat redistribution, abnormal lipids

-Take with food.

-Dose escalation may reduce the incidence of adverse effects.

-Most potent cytochrome P450 enzyme inhibitor.

-Mix oral solution with chocolate milk or Ensure to improve taste.

-Store capsules in the refrigerator.

Indinavir

(Crixivan)

200-, 400-mg capsules

800 mg q8h

 

(Administer around-the-clock to avoid significant fluctuation in serum levels.)

-GI intolerance

-Nephrolithiasis

-Indirect hyperbilirubinemia

-Hyperglycemia, fat redistribution, abnormal lipids

-Take on an empty stomach but may be taken with a light snack, if necessary.

-Drink at least 48 ounces of water daily.

-Separate dosing from ddI by 1 hour.

-Moderate cytochrome P450 enzyme inhibitor.

-Store and dispense in original container.

Nelfinavir

(Viracept)

250-mg tablet

50 mg/g oral powder

750 mg tid or

1250 mg bid

-Diarrhea (most common)

-Hyperglycemia, fat redistribution, abnormal lipids

-Take with food.

-Manage diarrhea with OTC agents.

-Moderate cytochrome P450 enzyme inhibitor.

Amprenavir

(Agenerase)

50-, 150-mg capsules

15 mg/mL oral solution

 

(Capsules and solution are NOT interchangeable on mg per mg basis.)

1200 mg bid (caps)

1400 mg bid (soln)

-GI intolerance

-Rash, headache

-Oral paresthesias

-Hyperglycemia, fat redistribution, abnormal lipids

-Take without regard to meals but avoid high fat meals.

-Avoid vitamin E supplements.

-Amprenavir is a sulfonamide, so watch for cross-sensitivity reactions.

-Moderate cytochrome P450 enzyme inhibitor.

Lopinavir/Ritonavir

(Kaletra)

133.3 mg LPV/33.3 mg RTV per capsule

400 mg LPV/100 mg RTV per 5 mL oral solution

3 caps or 5 mL bid

 

(Provides 400 mg LPV/100 mg RTV per dose)

-GI intolerance

-Fatigue, headache, asthenia

-Hyperglycemia, fat redistribution, abnormal lipids

-The first fixed-dose dual PI combination product.

-Take with food.

-Antiviral activity is due to the lopinavir.

-Store in refrigerator.  If kept at room temperature, stable for 2 months.

 

References available upon request.
Contact Dr. Sandra Blake, Assistant Professor, University of Lousiana at Monroe, College of Pharmacy
700 University, Monroe, LA 71209-0470 
e-mail pyblake@ulm.edu