DOH Medicaid Update February 2002 Vol.17, No.2

---

An estimated 580,000 people in New York State have been diagnosed with diabetes (4.2% of the population). Approximately one in twelve New Yorkers has diabetes, about half of whom are undiagnosed (Source: Behavioral Risk Factor Surveillance System). Diabetes is a chronic disease that, left untreated, can cause serious complications affecting the circulatory and nervous systems, kidneys, eyes and feet.

During 2001, the Medicaid Program has encouraged providers to treat and manage our Medicaid population with diabetes according to nationally recognized standards of care. The following 2001 Medicaid Update articles were printed and made available for you to use as a resource for you and your patients. These articles can be located:

on the Department of Health website at: http://www.health.state.ny.us/health_care/medicaid/index.htm
or by request, by emailing your address to: MedicaidUpdate@health.state.ny.us.

Preventive Foot Care for People With Diabetes (January)
Timely Blood Testing for Diabetes Detection (February)
Diabetes and Kidney Disease (March)
Diabetes and the Use of ACE Inhibitors (April)
Diabetes and Serious Eye Disease (May)
The Emerging Epidemic of Type 2 Diabetes in Children (June)
Obesity and the Link To Diabetes (July)
Diabetes and Exercise (August)
Smoking and the Link To Diabetes (September)
Diabetes and Insulin Pump Therapy (November)

---

---

In November 2001, the Agency for Healthcare Research and Quality (AHRQ) released a new synthesis of diabetes care, entitled: Improving Care for Diabetes Patients Through Intensive Therapy and a Team Approach. AHRQ-funded research findings demonstrated that, even though the treatment of diabetes is complex and major barriers to achieving good outcomes exist, glycemic control can be achieved and complications of diabetes postponed through a combination of intensive drug therapy and a team approach.

The concept of tight glycemic control was controversial until a decade ago when the United Kingdom Prospective Diabetes Study (UKPDS) for Type 2 diabetes and in the Untied States the Diabetes Control and Complications Trial (DCCT) for Type 1 diabetes demonstrated that any reduction in blood sugar (measured by HbA1c) is likely to reduce the risk of complications. The AHRQ funded studies used more broadly representative groups of patients than either the UKPDS or the DCCT studies.

The AHRQ research examined what can be achieved when treating patients in an office practice. A synthesis of the research of necessary components of effective management of diabetes is included in the chart below.

• More frequent use of two oral medications (a hypoglycemic and an agent to improve glycemic control), or one oral medication plus insulin
• Three or more daily injections for insulin recipients
• Four or more visits per year for many patients
• Visits with both physicians and nurse practitioners alternating with visits with a nurse practitioner alone
• Nurse practitioners, who were directly available at other times for phone contact, were able to facilitate more frequent adjustment of therapy when necessary
• Screening for complications
• Self-monitoring

AHRQ also released a new fact sheet showing that racial and ethnic minorities are at greater risk for diabetes and that certain minorities also have much higher rates of diabetes-related complications and death. This fact sheet, Diabetes and Disparities Among Racial and Ethnic Minorities, is based on a review of research articles that appeared in peer-reviewed journals.

Both of the AHRQ documents are available on the AHRQ Website.

The synthesis is available at:
http://www.ahrq.gov/research/diabria/diabetes.htm

The fact sheet is available at:
http://www.ahrq.gov/research/diabdisp.htm

For additional information regarding Medicaid payment on medically necessary care, services and supplies for the diagnosis and treatment of diabetes, please contact the Bureau of Program Guidance at (518) 474-9219.

---

For the next several months, the Medicaid Update will feature work of the New York State Department of Health's seven statewide asthma coalitions. The intent of these asthma coalitions is to reduce the burden of asthma, reduce emergency room utilization and to decrease school absences for children due to asthma. It is hoped that this information will assist Medicaid providers in rendering asthma care.

Interested in being part of your region's coalition? Contact Bill Campbell, NYSDOH, Bureau of Child and Adolescent Health, at (518) 474-2084 or wdc03@health.state.ny.us.

---

In late 2000, St. John's Riverside Hospital in Yonkers was awarded a Department of Health grant to be one of seven statewide asthma coalitions. The core of the Yonkers asthma program is a partnership between physicians, Yonkers schools, and St. John's Riverside Hospital. Prior to the partnership with St. John's, Yonkers schools were not equipped with the necessary equipment to treat students having asthma episodes at school. The school nurse's only option was to send the asthmatic student home or to an emergency room to receive treatment.

In the fall of 1998, St. John's obtained funding to donate asthma treatment equipment to allow nurses to administer breathing treatments to students at school. School nurses are working with students, parents, and physicians to help meet the provisions of the "Asthma Action Plan." The program, now into its fourth year, has been very successful. The number of treatments given by school nurses has consistently increased: from 937 in the first year, 1,285 in year two, to 1,682 last year. As a result of treatment, 95% of students were able to return to class and the number of times a student was sent to an emergency room was reduced by 91%. Concomitantly, the number of times students were sent home was drastically reduced.

Due to its success, the St.John's asthma program was adopted for implementation in all school districts in Westchester County. This school year, 2001-2002, 188 schools from 25 school districts (61% of all Westchester school districts)are participating in the program.

The Joint Commission on Accreditation of Health Care Organizations acknowledged St. John's asthma program with the Yonkers schools by awarding St. John's Riverside Hospital its prestigious 2001 Ernest A. Codman Award. The Codman Award recognizes excellence in the use of outcomes measurement to achieve health care quality improvement.

For more information on the St. John's asthma program contact Jeff Byrne, Asthma Program Director, at: (914)-964-4312 or jbyrne@riversidehealth.org.

For more information on NYSDOH statewide asthma coalitions, contact Bill Campbell, NYSDOH, Bureau of Child and Adolescent Health, at (518) 474-2084 or wdc03@health.state.ny.us.

---

Optometrists who are certified by the State Education Department (SED) to prescribe, in addition to "Phase I" agents, "Phase II" pharmaceutical agents for the treatment of glaucoma and ocular hypertension are also authorized to prescribe:

Optometrists who have received certification to prescribe "Phase I" therapeutic pharmaceutical agents will have a special privilege letter (U) that will precede their six-digit license number (ex. U123456).

Optometrists who are certified by SED to prescribe "Phase II" pharmaceutical agents for the treatment of glaucoma and ocular hypertension are limited to prescribing:

Optometrists who have received certification to prescribe "Phase I" and "Phase II" therapeutic pharmaceutical agents will receive the special privilege letter (V) that will precede their six-digit license number (ex. V234567).

The optometrist's license number, name, office address, and office telephone number should appear on the prescription.

---

Enclosed bed systems are beds which are surrounded by a canopy-type enclosure, from which an individual cannot leave at will.

Medicaid does not approve, cover, pay for or otherwise sanction the use of enclosed bed systems designed to prevent children and some adults with disabilities from getting out of bed.

Enclosed beds constitute a restraint and may pose even greater risks of harm than those posed by other, less restrictive interventions, such as increased monitoring, alarm systems, padding or placing the mattress on the floor.

The Commission on Quality of Care for the Mentally Disabled has concluded that there is no medical justification for enclosed bed systems. The real need is to proactively address the underlying medical and/or behavioral issues that give rise to the risk of harm. Restraints should be used on an emergency, time-limited basis only when an imminent risk of harm arises, and only the least restrictive form of restraint should be employed. The literature accompanying enclosed beds seems to promote their long-term use and makes no mention of improving the underlying problems that suggest the need for this level of intervention.

The Division of Quality Assurance of the Office of Mental Retardation and Developmental Disabilities has prohibited the use of these beds in all OMRDD-funded, operated or certified facilities.

Questions regarding this policy can be directed to the Medical Prior Approval Unit in the Bureau of Medical Review and Payment at 1-800-342-3005.

---

The following information is intended for pharmacies.

Prior authorization for serostim prescriptions must be obtained by the prescriber and verified by the pharmacist, prior to dispensing, for payment. A voice interactive phone system (VIPS) for this program allows access to the prior authorization system for Serostim 24 hours per day, 7 days per week. The toll free pharmacy prior authorization number is 1 (877) 309-9493.

• The prescriber is responsible for obtaining the prior authorization number. Prescribers are required to call the toll free telephone number and respond to a series of questions that identify the prescriber, the patient and the reason for prescribing. An eight-digit prior authorization number will be issued following completion of the questions. The eight-digit prior authorization number must be entered on the face of the prescription.
• The completed prescription may be filled at any New York State Medicaid enrolled pharmacy that stocks the drug.
• Pharmacists should review the prescription for all information necessary to fill the prescription according to New York State Medicaid parameters and look for an eight-digit prior authorization number on the face of the prescription, fax, or telephone order.
• Phone and fax orders for Serostim will be allowed. The prescriber is required to provide the pharmacy with the original script within 5 business days.
• A prescription may not be filled unless the pharmacy provider calls the Pharmacy Prior Authorization system and submits the necessary information. Completion of the prior authorization process by the pharmacy is required.
• For a claim to be paid, initial dispensing must occur on or after the date the prior authorization number is issued and within 28 days of the date prior authorization was obtained.
• Pharmacists must call the toll free telephone number, enter the prior authorization number and verify prescription information including patient identification.
• Once information is verified, the pharmacist will input pharmacy identification information including MMIS number, category of service (COS), telephone number and drug NDC. A prior authorization will be for a maximum 28-day supply, with no refill.
• If the pharmacy inputs information that does not match the prescriber input, the pharmacy will get an error message that directs them to contact the prescriber.
• Pharmacy response to the prior authorization system is not expected to take more than a few minutes.
• Fill the prescription on-line by placing the correct information into the prior authorization code field. The NCPDP format for this field uses the number "1" followed by the eight-numeric prior authorization number and then three zeroes/co-pay exemption values. Please check with your software vendor prior to submitting a claim regarding your ability to submit for this drug. No more than two claims can be submitted in one transaction with different prior authorization numbers. Refer to the ProDUR/ECC Provider Manual for complete instructions. Systems questions regarding electronic claims capture should call 1-800-343-9000.
• If the pharmacy is billing a paper claim, only the eight-digit prior authorization number is required for the prior authorization field. The eight-digit prior authorization number must be entered on the claim to receive payment. Prior authorization does not guarantee payment. Payment is subject to patient eligibility and other Medicaid guidelines.
• Verify and transcribe all prior authorization numbers correctly. If a claim is submitted electronically and the prior authorization number is transcribed incorrectly, the claim will go through electronically but Computer Sciences Corporation (CSC) will deny payment. These claims, if authenticated, can be resubmitted via paper using the correct prior authorization number.
• Serostim is reimbursable for patients that have Medicaid Disaster Relief Temporary Medicaid Authorization, (CINs beginning with the letter 'L'). Prescribers are required to get prior authorization for these patients. The eight-digit Prior Authorization number should be submitted on the paper claim.
• Serostim is not reimbursable to pharmacies on an outpatient basis for patients who have temporary Medicaid authorization, "unless their CIN starts with the letter 'L'."

A list of prior authorization questions that will need response and the proper format for responding follows the Serostim protocols. Fill in the information and have this information in front of you before calling into the prior authorization system. You should reproduce the blank form for future Serostim dispensing.

Pharmacy Prior Authorization Toll Free Number
1 (877) 309-9493

For your information, these are the NYS Medicaid Serostim protocols:

1. The patient must be 18 years or older with a clearly documented HIV diagnosis receiving at least 100% of estimated caloric requirement.
2. The patient must have had a documented unintentional weight loss of at least 5% from premorbid weight or weigh an amount that indicates recent significant weight loss or have a BMI <20kg/m2 in the absence of opportunistic infection.
3. The patient is on current anti-viral therapy with good viral suppression.
4. The patient has had recent blood work to confirm an amylase level ≤3 times upper normal limit, a creatinine level ≤2mg/dl or a fasting triglyceride level ≤500mg/dl.
5. The patient has no active malignancy (other than Kaposi's Sarcoma) and is not undergoing systemic chemotherapy, or therapy with interferon, anabolic steroids or investigational drugs.
6. The patient has no evidence of gastrointestinal (GI) bleeding, intestinal obstruction or malabsorption or severe liver dysfunction.
7. The patient has no history of angina pectoris, coronary artery disease, congestive heart failure, renal failure, or serious chronic edema. The patient has had previous unsuccessful treatment with other therapy alternatives or the use of these products was contraindicated.
8. The patient has no history of glucose intolerance. Hypertension is controlled.
9. Patient's current weight/appropriate dose:

Weight Range	Appropriate Dose
>55 kilograms (over 110 lb)	6 mg subcutaneously (SC) daily
45 to 55 kilograms (100 to 110 lb)	5 mg SC daily
35 to 45 kilogram (77 to 99 lb)	4 mg SC daily

Be prepared to answer these questions on the telephone:

Place 8 digit prior authorization number here	_________________________________
Recipient CIN (Client ID number is 2 alpha/5 numeric/1 alpha)	_________________________________
Pharmacy MMIS Number	_________________________________
Pharmacy Category of Service COS (0161, 0441, 0288)	_________________________________
Pharmacy telephone number with area code	_________________________________
Quantity per fill (not to exceed 28 doses)	____________________________doses
NDC of the Serostim dispensed	_________________________________

For policy questions, contact the Pharmacy Policy and Operations Unit at (518) 486-3209.
For systems questions, call 1-800-343-9000.

---

The following information is intended for prescribers of Serostim.

Prior authorization for serostim prescriptions must be obtained by the prescriber, and verified by the pharmacist, prior to dispensing, for payment. A voice interactive phone system (VIPS) for this program allows access to the prior authorization system for Serostim 24 hours per day, 7 days per week. The toll free pharmacy prior authorization number is 1 (877) 309-9493.

• Prescribers will be required to call the toll free telephone number and respond to a series of questions that identify the prescriber, the patient and the reason for prescribing. An eight-digit prior authorization number will be issued following completion of the questions. The eight-digit prior authorization number must be entered on the face of the prescription along with the prescriber's MMIS or license number. Prescriptions may be filled at any NYS Medicaid enrolled pharmacy that stocks the drug.
• Hospital,clinic, or other health care facility/group MMIS ID numbers cannot be used when prescribing Serostim. For orders written by an unlicensed intern or resident, the supervising physician's MMIS ID number or their license number must be entered.
• Prior authorizations will be limited to a maximum 28 injections (28 day supply)-no refill.
• To continue treatment, the patient must be re-examined and a positive therapeutic response documented. If a determination to continue Serostim therapy is made, the prescriber must obtain another prior authorization.
• If a patient has received a prior authorization for Serostim recently, the prescriber will be informed of that issuance date. A new prior authorization for Serostim should not be issued unless 75% of the previously authorized product has been used as determined by the previous issuance date.
• The VIPS system will inform prescribers if a patient has received three prior authorizations. The manufacturer's product information/package insert states "no significant additional efficacy was observed beyond 12 weeks". If a prescriber determines that continuation of Serostim beyond 12 weeks/3 prior authorizations is medically necessary, validating documentation must be available for review by the Department when requested.
• Phone and fax orders for Serostim will be allowed but the prescriber is required to provide the pharmacy with the original prescription including the prior authorization number within 5 business days. Prescriber response and issuance of the eight-digit prior authorization number is not expected to take more than a few minutes of telephone time.
• The dispensing pharmacist will call the same toll free telephone number and use the issued prior authorization number to complete the prior authorization information prior to dispensing.
• If Serostim is not dispensed by a pharmacy within 28 days of the order date, the prior authorization number will expire. A new prior authorization will be necessary for the patient to continue therapy.
• Serostim is reimbursable for patients with Medicaid Disaster Relief Temporary Medicaid Authorization, (CINs beginning with the letter 'L'). Prescribers are required to get prior authorization for these patients.
• Serostim is not reimbursable to pharmacies on an outpatient basis for patients who have temporary Medicaid authorization (TMA forms),"unless their CIN starts with the letter 'L'."
• The next page has a list of prior authorization questions that will need response and the proper format for responding. You should reproduce the blank form for future Serostim prescribing. Fill in the information and have that information in front of you before calling into the prior authorization system.
• The toll free pharmacy prior authorization number, 1 (877) 309-9493, can be used to cancel a prior authorization number that you obtained as long as the drug was not dispensed.

For technical assistance or policy questions, contact the Pharmacy Policy and Operations Unit at (518) 486-3209.

Pharmacy Prior Authorization Toll Free Number
1 (877) 309-9493

Serostim Call Worksheet: To facilitate the process, be prepared to answer these questions when you call the Pharmacy Prior Authorization Line. This documentation should be maintained in the patient's medical record.

PRESCRIBER IDENTIFIER - complete one of the following prescriber identifiers:
Physician or Nurse Practitioner MMIS ID	MMIS ID #_________________________
or NYS MD license/NP license	00________or_F_____________
or Out of State Physician license	___________________use your state abbreviation in 1st 2 spaces
or Out of State Nurse Practitioner license	____________________use your state abbreviation in 1st 2 spaces
Recipient CIN (Client ID number is 2 alpha/5 numeric alpha)	__________________________________
Prescriber telephone number(where you can be reached)	__________________________________
Dose (based upon weight-see dosing chart)	______________________mg SC daily_
Does patient have clearly documented HIV infection or AIDS?	_______________or_________________
Is patient 18 years of age or older?	__________________________________
Is patient receiving at least 100% of estimated caloric requirement on current nutritional regimen?	_______________or_________________
Are you or have you consulted with an HIV specialist?	_______________or_________________
Is patient receiving at least 100% of estimated caloric requirement on current nutritional regimen?	_______________or_________________
Is patient receiving at least 100% of estimated caloric requirement on current nutritional regimen?	_______________or_________________
Are you or have you consulted with an HIV specialist?	_______________or_________________
Does patient have unintentional weight loss of at least 5% or greater from baseline pre-morbid weight or weigh an amount that indicates a recent significant weight loss has occurred (BMI< 20kg/m2) in the absence of opportunistic infection?	_______________or_________________
Is patient on current anti-viral therapy with good viral suppression?	_______________or_________________
Does patient have recent blood work to confirm an amylase level < times the upper normal limit, a creatinine level ‹ or › 2 mg/dl or a fasting triglyceride level ‹ or › 500 mg/dl?	_______________or________________
Does the patient have an active malignancy (other than Kaposi's Sarcoma) or are they undergoing systemic chemotherapy, or being treated with interferon, anabolic steroids or investigational drugs?	_______________or________________
Does patient have evidence of GI bleeding, intestinal obstruction, malabsorption syndrome, or severe liver dysfunction?	_______________or________________
Does the patient have angina pectoris, coronary artery disease, congestive heart failure, renal failure or serious chronic edema?	_______________or________________
Does the patient have a history of glucose intolerance or uncontrolled hypertention?	_______________or________________
Have other treatment modalities been tried and failed?	_______________or________________
Patient's current weight in pounds	______________________________lbs
Patient's height in inches	___________________________inches
Patient's current Body Mass Index (BMI)	_________________________________
Quantity (maximum of 28 doses)	______________________doses(max 28)
Days supply (not to exceed 28 days)	______________________days (max 28)
Record the prior authorization number here (for your records) and on the top of the patient's Serostim prescription	_________________________________

Serostim protocols are based upon manufacturer recommendations and New York State policy determination.

1. The patient must be 18 years or older with a clearly documented HIV diagnosis receiving at least 100% of estimated caloric requirement.
2. The prescriber should be, or consult with, an HIV specialist.
3. The patient must have had a documented unintentional weight loss of at least 5% from pre-morbid weight or weigh an amount that indicates recent significant weight loss or have a BMI <20kg/m2 in the absence of opportunistic infection.
4. The patient is on current anti-viral therapy with good viral suppression.
5. The patient has had recent blood work to confirm an amylase level ≤3 times upper normal limit, a creatinine level ≤2mg/dl and a fasting triglyceride level ≤500mg/dl.
6. The patient has no active malignancy (other than Kaposi's Sarcoma) and is not undergoing systemic chemotherapy, or therapy with interferon, anabolic steroids or investigational drugs.
7. The patient has no evidence of gastrointestinal (GI) bleeding,intestinal obstruction or malabsorption or severe liver dysfunction.
8. The patient has no history of angina pectoris, coronary artery disease, congestive heart failure, renal failure, or serious chronic edema.
9. The patient has no history of glucose intolerance. Hypertension is controlled.
10. The patient has had previous unsuccessful treatment with other therapy alternatives or the use of these products was contraindicated.

Weight Range	Appropriate Dose
>55 kilograms (over 110 lb)	6 mg subcutaneously (SC) daily
45 to 55 kilograms (100 to 110 lb)	5 mg SC daily
35 to 45 kilogram (77 to 99 lb)	4 mg SC daily

---

The following list of enteral formulae is provided as a guideline for dispensers when the prescriber has ordered an enteral formula using a brand name. This is not an all-inclusive list, but is meant to assist providers in determining the correct item code for use in MMIS billing. Powdered, liquid and fiber-added forms of the same formula are billed under the same code. For products not listed below, providers are to use their judgment in selecting the appropriate product classification based upon the physician's order and the general categorical descriptions.

The calculation for pricing Enteral Therapy is as follows: Number of calories per can divided by 100 = number of caloric units per can. Medicaid will pay for up to 600 caloric units per item code per month. Each claim for B4150-B4156, Z2111 and Z2112 requires an EMEVS Dispensing Validation System (DVS) number.B9998 requires prior approval.

Please keep this information in the Enteral Therapy section of your MMIS Provider Manual. Coverage criteria for Enteral Therapy can be found in the July 2001 Medicaid Update.

Product	Code
80056 Powder	B4154
Acerflex	B4154
Accupepha	B4153
Advera	B4154
Alimentum	B4154
Alitraq Powder	B4154
Amin-Aid Powder	B4154
Analog MSUD	B4154
Analog XP	B4154
Analog XPTM	B4154
Analog XPHEN, TYR	B4154
Analog XMET	B4154
Analog XMTVI	B4154
Analog XLYS, TRY	B4154
Analog XLEU	B4154
Apple Fiber	B9998
Aquasol E	B9998
ATMF	B4150
Attain	B4150
BCAD-2	B4154
Bio-care	B4150
Boost	B4150
Boost High Protein Liquid	B4150
Boost High Protein Powder	B4150
Boost Plus	B4152
Boost Pudding	B4150
Boost w/Fiber	B4150
Casec Powder	B4155
Choice DM	B4154
Citrisource	B4150
Citrotein Powder	B4154
Compleat Modified	B4151
Compleat-B	B4151
Compleat Pediatric	B4151
Comply	B4152
Criticare-HN	B4153
Crucial	B4153
Cyclinex-1	B4154
Cyclinex-2	B4154
Deliver 2.0	B4152
Diabetisource	B4154
Doucal	B4154
Egg/Pro Powder	B4155
EleCare Powder	B4153
Elemental 028 Extra	B4154
Elementra	B4155
Enfamil AR	B9998
Enlive	B4150
Enriched Anti Form	B4155
Ensure	B4150
Ensure High Protein	B4150
Ensure HN	B4150
Ensure Light	B4150
Ensure Plus	B4152
Ensure Plus HN	B4152
Ensure Powder	B4150
Ensure Pudding	B4150
Ensure w/Fiber	B4150
Ensure w/Calcium	B4150
Entera	B4150
Entera Isotonic	B4150
Entera OPD	B4154
Enteralife HN	B4150
Enteralife HN-2	B4150
Entrition HN	B4150
Entrition 1.5	B4152
Epulor	B4155
Essential Pro Plus	B4155
Essential Protein	B4155
Fiberlan	B4150
Fibersource	B4150
Fibersource HN	B4150
Flavonex	B9998
Food Thicken Con per oz	Z2112
Food Thicken Reg per oz	Z2111
Forta Drink Powder	B4150
Forta Shake Powder	B4150
Fortison	B4150
Gevral Protein Pow	B4155
Glucerna	B4154
Glucerna Shake	B4154
Gluco-Pro	B4154
Glutamine-Plain Pow	B4155
Glutamine Rapid Release	B4155
Glutasolve	B4155
Glutasorb RTU	B4153
Glytrol	B4150
Hearty Balance	B4150
Hepatic-Aid Powder	B4154
Hominex-1	B4154
Hominex-2	B4154
HOM 1	B4155
HOM 2	B4155
HPF Plus	B4155
Immun-Aid	B4154
Immune Syst Boost	B4155
Immunocal	B4155
Imu-Plus	B4156
Impact	B4154
Impact 1.5	B4154
Impact Glutamine	B4153
Impact Oral	B4154
Impact Recover	B4154
IntensiCal	B4153
Introlite	B4150
Isocal	B4150
Isocal HN Plus	B4150
Isocal-HN	B4150
Isocal II	B4150
Isofiber	B4150
Isolan	B4150
Isomil	B4150
Isosource	B4150
Isosource 1.5	B4152
Isosource VHN	B4154
Isosource-HN	B4150
Isotein-HN Powder	B4153
Jevity	B4150
Jevity Plus	B4150
Juven	B4155
Ketonex 1	B4154
Ketonex 2	B4154
Kindercal	B4150
LactAid Tablets	B9998
Lactofree	B9998
L-Emental	B4153
L-Emental Hepatic	B4154
L-Emental Pediatric	B4153
Lipisorb Liquid	B4154
Lipisorb Powder	B4154
Lipomul	B4155
Lofenelac Powder	B4154
Lonalac Powder	B4150
Lorenzo Oil	B4154
Magnacal Renal	B4154
Maxamaid MSUD	B4154
Maxamaid XP	B4154
Maxamaid XMET	B4154
Maxamaid XPHEN, TYR	B4154
Maxamaid XLYS, TRY	B4154
Maxamaid XMTVI	B4154
Maxamaid XLEU	B4154
Maxamum MSUD	B4154
Maxamum XP	B4154
Maxamum XMET	B4154
Maxamum XLYS, TRY	B4154
MCT Oil	B4155
Meritene Liquid	B4150
Meritene Powder	B4150
Microlipid	B4155
Moducal Powder	B4155
MSUD Diet Powder	B4154
MSUD Maxamum	B4154
MSUD-1 Powder	B4154
MSUD-2 Powder	B4154
Naturite	B4150
Naturite Plus	B4152
NeoCalglucon	B9998
Neocate	B4153
Neocate One + Liquid	B4153
Neocate One + Powder	B4153
Nepro	B4154
Neutra-Phos	B9998
Newtrition	B4150
Newtrition HN	B4150
Newtrition Isofiber	B4150
Newtrition Isotonic	B4150
Newtrition 1.5	B4152
Nitrolan	B4150
NovaSource 2.0	B4152
NovaSource Pulmonary	B4154
NovaSource Renal	B4154
NuBasics	B4150
NuBasics 2.0	B4152
NuBasics Juice Drink	B4150
NuBasics Plus	B4152
Nubasics VHP	B4150
Nutri-Drink	B4150
Nutramigen	B4150
Nutrassist-1.5	B4152
Nutren Junior	B4150
Nutren-1	B4150
Nutren-1.5	B4152
Nutren-2	B4152
Nutrifocus	B4152
Nutrihep	B4154
Nutrilan	B4150
NutriRenal	B4154
NutriVent	B4154
NutriVir	B4154
Optimental	B4153
OS 1	B4154
OS 2	B4154
Osmolite	B4150
Osomolite-HN	B4150
Osomolite-HN Plus	B4150
Pediasure	B4150
Pediasure w/Fiber	B4150
Pepdite One+	B4153
Peptamen	B4154
Peptamen 1.5 Diet	B4153
Peptamen Jr	B4154
Peptamen VHP	B4154
Peptical	B4153
Perative	B4154
Periflex	B4154
PFD-2	B4155
Phenex 1	B4154
Phenex 2	B4154
PhenylAde Powder	B4154
Phenylfree Powder	B4154
Phenylfree 2	B4154
Phenylfree 2 HP	B4154
Phlexy-10 Capsules	B4155
Phlexy-10 Drink Mix	B4155
PKU2	B4154
Polycose Liquid	B4155
Polycose Powder	B4155
Portagen Powder	B4150
Pregestimal	B4154
ProBalance	B4150
ProCel Powder	B4155
Product 3232A	B4155
Product 80056	B4154
Profiber Liquid	B4150
Promix	B4155
ProMod Powder	B4155
Promote	B4150
Propac Powder	B4150
Pro-Peptide	B4154
Pro-Peptide VHN	B4154
Pro-Phree	B4155
Propimex 1	B4154
Propimex 2	B4154
ProSobee	B4151
Protain XL	B4154
Provide	B4154
ProViMin	B4154
Pulmocare	B4154
Reabilan	B4153
Reabilan-HN	B4154
ReGain Plus	B4154
Renalcal	B4154
Re-Neph	B4154
Re-Neph Free	B4154
Replete w/ or w/o Fiber	B4154
Resource	B4150
Resource Arginaid	B4155
Resource for Kids w/Fiber	B4150
Resource Diabetic	B4150
Resource for Kids	B4150
Resource Fruit Bev.	B4150
ReSource Inst Protein Pwd	B4155
Resource Plus	B4152
Resource Select	B4154
Respalor	B4152
Restore-X	B4155
Ross Carbohydrate Free	B4155
Sandosource Peptide	B4154
Scandi Shake	B4152
Similac PM 60/40	B4154
SLD	B4154
SoyPro	B4155
Stresstein Powder	B4154
Subdue	B4153
Subdue Plus	B4153
Sumacal	B4155
Suplena	B4154
Sustacal	B4150
Sustacal Plus	B4152
Sustacal Powder	B4150
Sustacal Pudding	B4150
Sustacal w/fiber	B4150
Sustagen Powder	B4150
Sympt-X Glutamine	B4155
Tolerex Powder	B4156
Traumacal	B4154
Traum-Aid HBC	B4154
Travasorb Hepatic	B4154
Travasorb-MCT	B4154
Travasorb Renal	B4154
Travasorb Standard	B4156
Travasorb-HN	B4153
TwoCal-HN	B4152
Ultracal	B4150
Ultracal HN Plus	B4150
Ultralan	B4152
Ultracare Kids	B4154
Vital-HN	B4153
Vitaneed	B4151
Vivonex Flavor Pkts	B9998
Vivonex Pediatric Pd	B4153
Vivonex Plus	B4154
Vivonex Standard	B4156
Vivonex-TEN	B4154

---

---

Note: The NYSDOH Drug Utilization Review (DUR) Board reprints the following article for educational purposes. The Board's mission is to encourage wise drug use so that Medicaid recipients receive the most appropriate and least hazardous pharmacotherapy available. Articles describing points of wise drug use will appear from time to time in the Medicaid Update. If you have any questions, please contact the DUR Program at (518) 474-6866.

Safety and efficacy of treatments are the primary considerations when selecting among antipsychotic treatments for patients who suffer from schizophrenia. However, medication and other costs are important to consider as well. With the rising use of the second-generation antipsychotics (SGAs), pharmacy budgets nationwide both in the public and private sectors are escalating. Moreover, the overall treatment for schizophrenia accounts for about 2.5% of the total healthcare expenditures nationally and more than 32.5 billion dollars being spent in the United States annually (1). One of the primary costs in the cost-treatment equation, other than loss of income, is inpatient hospitalization. This factor accounts for more than 30% of the overall treatment costs while only 5% of expenditures for schizophrenia treatment are owed to direct medication costs (2).

Many variables may contribute to frequent hospitalizations including an early age of onset, extensive functional impairment/disability, concurrent medical illness, rejection of treatment/poor compliance and adherence, self-neglect and acts of violence. Therefore, selecting treatments, which may improve many of these issues, may help alleviate rising costs and actually prove to be cost-effective therapies. The SGAs have demonstrated many advantages over conventional antipsychotic treatments such as lower rates of extrapyramidal side effects (EPSs), tardive dyskinesia (TD) and improvement in some symptom and cognitive domains (3).

Five SGAs are currently approved for use in the US: clozapine, risperidone, olanzapine, quetiapine and ziprasidone. Clozapine is the only SGA that has consistently demonstrated superiority for treatment resistance, however it is reserved for second-line use due to side effect concerns (4). A few other of the SGAs in pivotal trials have demonstrated superiority to conventional antipsychotics in some symptom domains in treatment-responsive individuals with schizophrenia. Risperidone was found to be superior to both positive and negative symptoms as compared to haloperiodol (5). This finding has been replicated in long-term data as well using ideal doses of risperidone (6). Olanzapine has shown benefits over haloperidol in the negative symptom domain only (7) while the other SGAs available appear to be as effective as haloperidol with a better side effect profile (8,9,10). Furthermore, risperidone and olanzapine appear to be more effective in treatment-resistance than traditional antipsychotics (11,13). Dosing is crucial for maximizing efficacy for some of the SGAs. Risperidone is most effective in doses lower than 6 mg/day while clozapine response is greatest at blood levels greater than 350 ng/ml (13,14). Ideal dosing is not yet known for the other SGAs however, dosing appears to be gravitating upwards for olanzapine and quetiapine, which may contribute to added costs with little additional benefit.

The newer antipsychotics have much improved rates of TD incidence and EPS which, in addition to improved efficacy, may contribute to better compliance and adherence and less rejection of treatment. Some of the SGAs carry additional side effect burdens that may lead to long-term health morbidities and mortalities, including new onset medical illnesses, which may offset some of the cost benefits the SGAs may have. Weight gain is a side effect of most of the SGAs. However, clozapine and olanzapine are associated with the greatest gains. Gains of 4 to 5 kg are considered average after 10 weeks on olanzapine and clozapine treatment while gains typically seen with risperidone are around 2 kg (15). Consequences of weight increases include cardiovascular morbidity and mortality, increased risk of some cancers in men and women, psychosocial distress, nonadherence with treatment and increased risk of diabetes (16). Diabetes may also occur without large gains in weight but is most likely to occur with clozapine or olanzapine treatment (17). All of these consequences, however, can be extremely costly and contribute to increases in hospitalization and overall treatment costs.

Hospitalization rates with oral conventional antipsychotic treatment are as high as 50% annually (18). This is mostly likely due to untoward side effects such as EPS and tardive dyskinesia but may also be due to worsening of cognition, lack of efficacy, or secondary negative symptom worsening. The SGAs are associated with lower rates of rehospitalization than the conventional agents with annual rates of 10-20% with clozapine, risperidone, and olanzapine treatment (19,20,21). In chronic patients with schizophrenia, the SGAs have also been found to have lower rehospitalization rates than conventional depot preparations (22). While compliance is implied with the depot formulations, better adherence to therapy due to improved side effect profiles may offer one explanation. In fact, Desai, (23) switched patients from depot formulations to risperidone treatment and studied patients' opinions on each of the regimens. A significantly greater percentage of patients favored risperidone. Moreover, a growing body of literature suggests that SGAs are indeed cost-effective as compared to traditional antipsychotics (24,25,26,27,28). Most of the data on cost-effectiveness is published in regard to risperidone and clozapine, but a few reports of olanzapine are emerging (29,30).

Little direct comparative data pertaining to costs and outcomes for the SGAs are available but direct costs of therapy differ for these medications. Risperidone and olanzapine claim the largest market share in terms of overall use, each accounting for 25-30% of the SGA market (31). National data sources indicate that risperidone costs approximately $7.50 daily for an average dose (4.6 mg) in schizophrenia. Olanzapine at an average dose (13.5 mg/day) costs about 40% more ($10.30) (32). Interestingly, quetiapine and ziprasidone are competitively priced to risperidone. There is no compelling data demonstrating olanzapine's benefits over the other SGAs for its increase in cost. Furthermore, several studies have demonstrated higher discharge rates, lower costs and preferability of risperidone as compared to olanzapine (33,34,35,36). Little comparative data is available for quetiapine and ziprasidone in regard to outcomes and costs.

It is not surprising that the SGAs are fast becoming first line antipsychotics for the treatment of schizophrenia owing to a whole host of reasons for this rapid growth. However, not all SGAs are alike and clinicians must consider dosage, side effects, and cost when making a selection. Comparison trials are beginning to differentiate efficacy, safety and long-term outcomes associated with these antipsychotic medications. These differences should affect drug choice for individual patients and for healthcare systems.

References:

1. Williams R, Dickson RA: Economics of schizophrenia. Can J Psychiatry 40:60S-67S, 1995.
2. Rice DP. The economic impact of schizophrenia. J. Clin Psychiatry 1999; 60(suppl 1):4-6
3. Love RC: Novel versus conventional antipsychotic drugs. Pharmacotherapy 16:6-10, 1996.
4. Conley RR, Buchanan RW. Evaluation of treatment-resistant schizophrenia. Schizophr Bull 1997; 23 (4):663-74.
5. Marder SR, Davis JM, Chouinard G. The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis; combined results of the North American trials.J Clin Psychiatry 1997; 58:538-546.
6. Csernansky J, Okamota A. Risperidone vs. haloperidol for prevention of relapse in schizophrenia and schizoaffective disorders: a long-term double-blind comparison. Presented at: the 10^th Biennial Winter Workshop on Schizophrenia; February 5-11, 2000; Davis, Switzerland.
7. Beasley CM Jr, Tollefson G, Tran P, Satterlee W, Sanger T, Hamilton S. Olanzapine versus placebo and haloperidol: acute phase results of the North American Double-blind olanzapine trial.Neuropsychopharmacology1996;14:111-123
8. Arvanitis LA, Miller BG. Multiple fixed doses of "Seroquel" (quetiapine) in patients with acute exacerbation of schizophrenia: a comparison with haloperidol and placebo. The Seroquel Trial 13 Study Group. Biol Psychiatry 1997;42:233-246.
9. Small JG, Hirsch SR, Arvanitis LA, Miller BG, Link CG, Seroquel Study Group.Quetiapine in patients with schizophrenia. A high -and low -dose double -blind comparison with placebo. Arch Gen Psychiatry 1997; 54:549-557.
10. Data on file, Study 115, Pfizer Inc.
11. Wirshing DA, Marshall BD, Green MF, Mintz J, Marder SR, Wirshing WC. Risperidone in treatment-refractory schizophrenia. Am J Psychiatry 1999; 156(9):1374-9.
12. Breier A, Hamilton SH. Comparative efficacy of olanzapine and haloperidol for patients with treatment-resistant schizophrenia. Biol Psychiatry 1999; 45(4):403-11.
13. Love RC, Conley RR, Kelly DL, et al. A dose-outcome analysis of risperidone. J Clin Psychiatry 1999; 60:771-775.
14. Bell R, McLaren A, Gaalanos J, Copolov D: The clinical use of plasma clozapine levels. Aust N Z Psychiatry 1998 Aug; 32 (4): 567-74. Clozapine blood levels.
15. Allison DB, Mentor JL, Moonseong H, et al. Antipsychotic-induced weight gain: a comprehensive research synthesis. AM J Psychiatry 1999; 156:1686-1696.
16. Van Itallie TB: Obesity: adverse effects on health and longevity. Am J Clin Nutr 32:2723-33, 1979.
17. Casey D. Weight gain and glucose metabolism with atypical antipsychotics. Presented at: the 38^th American College of Neuropsychopharmacology; December 1999; Acapulco, Mexico.
18. Weiden P, Aquila R, Standard J: Atypical antipsychotic drugs and long-term outcome in schizophrenia. J Clin Psych 1996; 57:53-60
19. Conley RR, Love RC, Kelly DL, Bartko JJ. Rehospitalization rates of patients recently discharged on a regimen of risperidone or clozapine.American Journal of Psychiatry 1999; 156:863-868.
20. Essock SM, Hargreaves WA, Covel NH, Goethe J: Clozapine's effectiveness for patients in state hospitals: results from randomized trial.Psychopharmacology Bulletin 1996; 32(4):683-97.
21. Rabinowitz J, Licthenberg P, Kaplan Z, Mark M, Nahon D, Davidson M. Rehospitalization rates of chronically ill schizophrenic patients discharged on a regimen of risperidone, olanzapine, or conventional antipsychotics. Am J Psychiatry 2001; 158:266-269.
22. Love RC, Conley RR, Kelly DL, Bartko JJ. A Comparison of rehospitalization rates between patients treated with atypical antipsychotics and those treated with depot antipsychotics.Schizophrenia Research 1999; 36(1-3): 345.
23. Desai NM, Hug Z, Martin SD, McDonald G: Switching from depot antipsychotics to risperidone: results of a study of chronic schizophrenia. The schizophrenia treatment and assessment group. Adv Ther 1999;16(2): 78-88.
24. Revicki, DA. Pharmacoeconomic evaluation of treatments for refractory schizophrenia: clozapine-related studies. J Clin Psychiatry 1999; 60(suppl): S101-S109.
25. Rosenheck R, Cramer J, Weichum X, Thomas J, Henderson W, Frisman L, Fye C, Charney D, for the Department of Veteran Affairs Cooperative Study Group on Clozapine in Refractory Schizophrenia. A comparison of clozapine and haloperidol in hospitalized patients with refractory schizophrenia. N Engl J Med 1997; 337: 809-15.
26. Albright P, Livingstone S, Keegan DL, et al: Reduction of healthcare resource utilization and costs following the use of risperidone for patients with schizophrenia previously treated with standard antipsychotic therapy.Clin Drug Invest 11(5): 289-299, 1996.
27. Finley PR, Sommer BR, Corbitt JL, Brunson GH, Lum BL. Risperidone: clinical outcome predictors and cost-effectiveness in a naturalistic setting. Psychopharmacol Bull 1998; 34:75-81.
28. Nightengale BS, Crumly JM, Liao J, Lawrence BJ, Jacobs EW. Economic outcomes of antipsychotic agents in a Medicaid population: traditional agents vs. risperidone. Psychopharmacol Bull 1998; 34:373-382.
29. Hamilton SH, Revicki DA, Edgell ET, Genduso LA, Tollefson G. Clinical economic outcomes of olanzapine compared with haloperidol for schizophrenia. Results from a randomized clinical trial.Pharmacoeconomics 1999; 15:469-480.30 Glazer WM, Johnstone BM. Pharmacoeconomic evaluation of antipsychotic therapy for schizophrenia. J Clin Psychiatry 2997; 58(suppl 10):50-54.
30. IMS Health, NDTI, 1999.
31. IMS Health, NDTA 3 months ending December 1999.
32. Kelly DL. Nelson MW, Love RC, YU Y, Conley RR. Outcomes and economic considerations with atypical antipsychotics: risperidone vs. olanzapine.Psychiatric Services 2000; 52:676-678.
33. Prosyshyn RM, Zerjav S: Drug utilization patterns and outcomes associated with in-hospital treatment with risperidone or olanzapine.Clin Ther 20:1203-1217, 1998.
34. Nasrallah HA, Chan Y, Votolato NA: Higher costs of olanzapine compared to risperidone in acute psychotic relapse. In: Abstracts of the XXIst Collegium International Neuro-Psychopharmacologicum (CINP) Congress, Glasgow, Scotland, July 1998.Abstract PM04012.
35. Rabinowitz J, Lictenberg P, Kaplan Z. Comparison of cost, dosage, and clinical preference for risperidone and olanzapine. Schizophr Res 2000:46:91-96.

---

Effective for dates of services on or after February 1, 2002, claims for compounded prescriptions must be submitted using the NDC codes for the ingredients, or by using the corresponding Z code. Applicable dispensing fees will be reimbursed.

Code	Type	Reimbursement
Z0900	Ointment	usual or customary, up to $50.00
Z0920	Lotion	usual or customary, up to $50.00
Z0930	Cream	usual or customary, up to $50.00
Z0940	Capsule	usual or customary, up to $50.00
Z0950	Tablet	usual or customary, up to $50.00
Z0960	Other	usual or customary, up to $100.00

In order for Medicaid to consider a compound reimbursable, the following conditions must be met:

• A combination of any two or more legend drugs found on the List of Medicaid Reimbursable Drugs; or,
• A combination of any legend drug(s) included on the List of Medicaid Reimbursable Drugs and any other item(s) not commercially available as an ethical or proprietary product, or,
• A combination of two or more products which are labeled "Caution: For Manufacturing Purpose only."

Refer to Pharmacy Provider Letter dated December 21, 2001 for specific billing details.
Questions regarding this article should be directed to the New York State Department of Health, Bureau of Program Guidance, Pharmacy Policy and Operations at (518) 486-3209.

---

The State Department of Health welcomes your comments or suggestions regarding the Medicaid Update.

Please send suggestions to the editor, Timothy Perry-Coon:

NYS Department of Health
Office of Medicaid Management
Bureau of Program Guidance
99 Washington Ave., Suite 720
Albany, NY 12210
(e-mail MedicaidUpdate@health.state.ny.us )

The Medicaid Update, along with past issues of the Medicaid Update, can be accessed online at the New York State Department of Health web site: http://www.health.state.ny.us/health_care/medicaid/program/main.htm