Provider Update
Volume 23, Issue 3
May/June
2006
The Take Charge Family Planning Waiver Program
The Department of Health and Hospitals will soon be implementing a Section 1115 Demonstration Waiver to provide family planning services for women between the ages of 19-44 who have income up to 200% of the Federal Poverty Level. The waiver program, named "Take Charge" has a specified benefit package. Services will include yearly physical exams, laboratory tests, contraceptive counseling, medications and supplies (such as birth control pills, patches, injections, intrauterine devices, diaphragms, etc.). Voluntary sterilization procedures are also included. Services may be provided by any enrolled Medicaid provider(s) whose scope of practice permits the delivery of the services covered by the waiver program. More specific information about the Take Charge Family Planning Waiver will be included in remittance advice messages prior to the implementation of the program. The anticipated implementation date is September 1, 2006.
Changes in the Elderly and Disabled Adult Waiver Service Package
Effective July 1, 2006, the Department of Health and Hospitals will implement the following changes in the service package for the Elderly and Disabled Adult Waiver.
� Termination of coverage for Household Supports services; and
� Combining Personal Supervision (Day) and Personal Supervision (Night) into one service known as Companion Service.
If you have any questions, please contact your Division of Long Term Supports and Services regional office staff and/or support coordination agencies.
Hospital Precertification
Physician to Physician Conference
The Bureau of Health Services Financing's policy for physician to physician conferences regarding hospital pre-certification denials is as follows:
� All physician to physician conferences must be scheduled and completed within six months of the date of the first pre-cert denial.
� If a hospital misses a physician to physician conference the hospital would forfeit the right to further physician to physician conferences and would have to go through the appeal process for further relief.
� If a hospital missed a physician to physician conference because of extenuating circumstances and has less than two (2) missed physician to physician reviews, Unisys will reschedule a conference.
Any questions regarding the above policy and procedures should be directed to Sandy Whitcomb or Janeen Tarrow in the Unisys Hospital Pre-certification Department at 1-800-877-0666.
CommunityCARE Becomes a State Plan Service
The Louisiana Medicaid CommunityCARE Program, previously operated under the provisions of a 1915(b) Waiver, has been approved by CMS to operate under the authority of the Title XIX Medicaid State Plan effective April 1, 2006. The program will continue to operate in accordance with Medicaid Managed Care regulations set forth in the 42 CFR, Part 438 for Primary Care Case Management (PCCM).
However, under the State Plan provisions, the following additional groups of Medicaid recipients must be exempt from mandatory participation in the CommunityCARE Program: SSI recipients under the age of 19, New Opportunities Waiver (NOW) recipients under the age of 19, Children's Choice Waiver recipients under the age of 19 and recipients of Title V services (Children's Special Health Services - OPH).
Over the next few months the CommunityCARE Program staff will take actions to comply with the new requirement. Providers should monitor remittance advice messages for further information as these changes are implemented.
RA Messages
Mental Health Rehabilitation Providers
Effective with dates of service June 1, 2006 the reimbursement rate for Medication Assessment, Monitoring and Education (Procedure Code 90862) is being increased. The maximum allowable fee for this procedure will be $49.64 when the servicing provider is a psychiatrist, $39.71 when the servicing provider is an APRN and $33.26 when the servicing provider is a RN. Providers must enter the servicing provider's (Psychiatrist or APRN only) individual Medicaid Provider Number in Item 24 K of the CMS 1500 claim form. If Item 24 K is blank, payment will be made at the RN rate.
New Opportunities Waiver Services Providers
Due to information from CMS, beginning June 15, 2006, providers of Medicaid New Opportunities Waiver Services (NOW) will no longer be reimbursed for providing waiver services to participants during inpatient hospital days. See DHH website for further information.
Professional Services Providers - Corrections to 2006 Professional Services Training Manual
Pediatric Moderate (Conscious) Sedation Policy
The following correction is to be made on page 20 of the 2006 Professional Services Training manual:
The last sentence under the heading of 'Pediatric Moderate (Conscious) Sedation' should read: "No claims will be considered for recipients twenty-one years of age or older."
Web Address for OMB No. 0937-0166 Form
The following correction is to be made on page 82 of the 2006 Professional Services Training manual:
The website address for obtaining the OMB No. 0937-0166 form should be:
http://opa.osophs.dhhs.gov/pubs/publications.html
If you attended the 2006 Professional Services Provider Workshop, please make these corrections in your manual. The corrections will be made in the manual available on-line at: www.lamedicaid .com
Question and Answer Corner
Question
If a CommunityCARE recipient receives private insurance while linked to CommunityCARE Primary Care Provider (PCP), can his PCP refuse to continue treating him/her as a Medicaid recipient and bill only the third party insurance?
Answer
No, when the CommunityCARE PCP signed the supplemental enrollment agreement, he/she agreed to take assignment of Medicaid enrollees on a month to month basis (i.e. patients are linked in monthly intervals).
If a CommunityCARE recipient gets insurance at some point during the month, the provider still has an obligation to continue to accept him/her as a Medicaid recipient until the CommunityCARE
linkages closes. Linkages automatically close at the end of the month in which third party insurance information is added to the Medicaid files, because Medicaid eligibles with third party insurance, which includes physician benefits, are not required to be in CommunityCARE.
However, if the recipient does not notify Medicaid to add the third party coverage, the recipient will remain linked to the PCP.
NOTE: Providers may also notify Medicaid if they are aware that a recipient has third party coverage. Medicaid will attempt to verify the coverage.
Louisiana Drug Utilization Review (LADUR) Education
Benign Prostatic Hyperplasia - A Focus on Medication Management
By: Justin Sherman, M.C.S., Pharm.D.
Assistant Professor of Pharmacy Practice
University of Louisiana at Monroe
College of Pharmacy
Issues
� Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in American males.
� ...at the crux of the problem is a gradual change in prostate size, which can begin when the male
is in his thirties and forties.
� The goals of treatment for BPH are to improve symptoms, to halt disease progression,
and to prevent complications resulting from untreated or undertreated BPH.5
Benign prostatic hyperplasia (BPH) is the most common benign neoplasm in American males. The prostate itself is a male accessory sex gland with minimal physiologic use - secretion of an alkaline fluid that becomes part of the semen during
ejaculation.1 However, its impact on quality of life, especially in elderly patients, can be quite profound. Usually, at the crux of the problem is a gradual change in prostate size, which can begin when the male is in his thirties and forties. The symptoms begin to manifest and become especially troubling with age. For example, 90% of males between seventy and ninety years of age have significant BPH
symptoms.1
Presentation of BPH
Although the term "dysuria" was used to describe symptoms of BPH, this term has fallen out of favor to "lower urinary tract symptoms" (LUTS), a more general
term.2 Patients who present with LUTS associated with BPH have a progression of symptoms. The growth of prostate tissue over time causes a mechanical obstruction during the earlier phase of BPH by decreasing the urethral lumen size. Obstructive symptoms are present during this phase, including difficulty initiating urination or having a weak stream. Some patients even push on their bladder to initiate urination. Other symptoms include involuntary postvoid dripping and a sensation of having a full bladder with an inability to completely
void.1
As patients have progressive voiding problems, the irritative symptoms indicative of the later phase of BPH begin to emerge. Unvoided urine will eventually cause the bladder to become hypersensitive to even small amounts of
urine.3 As a result, patients are likely to experience increased frequency, sometimes to the point that they exhibit "toilet mapping", which involves the patient locating the nearest bathroom immediately upon entering a
building.2 They also have increased urgency and nocturia. These patients may even keep a makeshift bedpan in the bedroom. Finally, if patients present with BPH complications, such as hydronephrosis, hematuria, renal insufficiency, or frequent urinary tract infections, they should be referred to a urologist.
The clinician should not assume symptoms are a definitive diagnosis of BPH by themselves. Other disease states are usually ruled out first, including prostate cancer, prostatitis, and urinary tract
infections.4 The digital rectal examination (DRE) and the prostate specific antigen (PSA) laboratory tests are helpful in this regard. The DRE roughly estimates the prostate size by examination with a finger through the rectal mucosa. While the normal prostate is soft, pliable, and about the size of a walnut, the prostate affected by BPH can be enlarged with a rubbery consistency. Likewise, prostatitis presents as an indurated or tender prostate, and a cancerous prostate could be enlarged, firm, or nodular. Although an experienced clinician who performs the DRE for the same patient each year is most reliable, the DRE still tends to underestimate the size of larger
prostates.4
The PSA helps eliminate prostate cancer as a diagnosis. For example, the likelihood of a patient having prostate cancer when the PSA is greater than 10 ng/ml is 50%.5 In contrast, a PSA of < 4 ng/ml is usually considered "normal". However, a PSA between 4 and 10 ng/ml is a "gray area" that needs further investigation, because prostate cancer is still diagnosed 25% of the time while in this range.5 The main definitive way of ruling out cancer at this point, of course, is to perform a biopsy if the patient presents with a DRE and a PSA that are clinically suspicious for cancer.
The American Urological Association advocates the Symptom Score Index Questionnaire (SSI) as a very useful tool to establish a baseline of symptom severity and efficacy of treatment. The questionnaire consists of seven questions that are ranked from one to five in symptom severity
(TABLE 1). Increased LUTS is represented by an increased score, with a maximum of 35. The severity of symptoms is indicated by this score, such as mild (score of 0 - 7), moderate (score of 8 - 19), and severe (score > 20).6 Although the questionnaire was designed for patient self-administration, the clinician may need to define terms for better patient comprehension. Also, the interviewer conducting the questionnaire should maintain consistency throughout the patient's therapy. Finally, the designations of mild, moderate, and severe BPH are based on an arbitrary point system and may not necessarily indicate the efficacy of the medication. The degree of increase or decrease of the score from baseline is more reliable. Patients detect a "slight" or "moderate" improvement when the score decreases by 3 to 4 points or 5 to 7 points,
respectively.4
|
TABLE 1
The American Urological Association Symptom Score Index Questionnaire
for Benign Prostatic Hyperplasia
Instructions: Please answer the questions that follow according to the scale below:
0 = Not at all
1 = Less than 1 time in 5
2 = Less than half the time
3 = About half the time
4 = More than half the time
5 = Almost always
1. Throughout the past month, how often have you had a sensation of not emptying your bladder completely after
you finished urinating?
2. Throughout the past month, how often have you had to urinate again less than 2 hours after you finished
urinating?
3. Throughout the past month, how often have you found that you stopped and started again several times when
you urinated?
4. Throughout the past month, how often have you found it difficult to postpone urination?
5. Throughout the past month, how often have you had a weak urinary stream?
6. Throughout the past month, how often have you had to push or strain to begin urination?
Instructions for question #7: Please answer the following question with a number response.
7. Throughout the past month, how many times did you most typically get up to urinate from the time you went to
bed at night until the time you got up in the morning? |
Treatment Options
The goals of treatment for BPH are to improve symptoms, to halt disease progression, and to prevent complications resulting from untreated or undertreated BPH.5 Since quality of life is an important consideration, a patient's choice of therapy should take precedence once the SSI is completed. Therefore, an appropriate treatment for a patient with mild symptoms (SSI < 7) and no treatment request would include watchful waiting, annual PSA and DRE monitoring, and lifestyle changes (i.e., stopping coffee consumption or diuretics at bedtime). Patients with moderate to severe symptoms (SSI 8 - 19 or 20 - 35, respectively) would be offered either pharmacologic or surgical intervention.6 A more detailed nomogram can be found in
FIGURE 1.
Figure 1
Of the choices for moderate symptoms, BPH medications are usually preferred, including alpha1 receptor inhibitors or 5 alpha reductase inhibitors. These are the two classes of medications available for BPH. Alpha1 receptor inhibitors decrease smooth muscle tone in the prostate tissue, bladder neck, and urethra. This action is quick compared to 5 alpha reductase inhibitors, thus making them the drugs of choice for patients needing immediate symptom
relief.7
All of the clinically available alpha1 receptor inhibitors are equally efficacious since they all decrease the SSI an average of 5 - 7 points when compared to placebo.
2 However, they can be stratified into three classes depending upon their adverse event profile, degree of receptor and subreceptor selectivity, and chronology of discovery. Phenoxybenzamine was the first alpha receptor inhibitor to be used for BPH, but it was very nonselective (inhibiting alpha2 receptors) and caused severe cardiovascular adverse effects, such as tachycardia, arrhythmias, increased blood pressure, and heart palpitations.
The 2nd generation alpha1 receptor inhibitors include doxazosin and terazosin. Because they reduce blood pressure, they are FDA-approved for both hypertension and BPH. Therefore, sitting and standing blood pressure should be checked to determine whether the patient can tolerate doxazosin or terazosin. Also, patients should be cautioned to use them only at bedtime to avoid the orthostasis or dizziness that may occur when starting the medication, known as the "first dose
effect".8 This effect is more pronounced when combined with other blood pressure medications. Finally, this medication must be started at a low dose and titrated up slowly to avoid the first dose effect. A feasible titration schedule would be to start with a 1 or 2 mg dose of either of these medications and double the dose every two weeks until the maximum dose is reached (8 mg and 10 mg for doxazosin and terazosin, respectively), adverse effects occur, or LUTS are alleviated. Onset of symptom relief occurs at 1 to 2 weeks and peaks at 2 to 4
weeks.6
Another issue of concern must be discussed when using doxazosin or terazosin: neither should be used as sole therapy for patients with both BPH and hypertension. As an antihypertensive medication, an alpha1 receptor inhibitor is mildly effective when compared with other antihypertensives. Also, the ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) study revealed some intriguing results for this patient
population.9 The doxazosin arm was discontinued early because it had no effect on reducing CHD or total mortality, and there was an 80% increased risk for developing heart failure. Therefore, 2nd generation alpha1 receptor inhibitors should not be used as sole therapy for the dual treatment of BPH and hypertension. In the ALLHAT study, adding a thiazide diuretic attenuated the risk for heart
failure.9
The 3rd generation alpha1 receptor inhibitors, tamsulosin and alfuzosin, are uroselective because they act on prostate tissue without decreasing blood pressure. In the case of tamsulosin, it is more selective at inhibiting the alpha1a than the alpha1b subreceptors, which occur in the prostate tissue and the peripheral vascular system,
respectively.10 Thus, they do not cause a significant reduction in blood pressure (and are not FDA approved for this indication) and do not need to be titrated for effect. Tamsulosin is available in 0.4 mg doses, and alfuzosin is available in a 10 mg dose. Both are dosed once daily but should be given after the same meal each day rather than at bedtime. Also, they relieve symptoms quicker (1 day for onset and 1 week for peak relief) compared to the 2nd generation alpha1 receptor
inhibitors.6 However, waiting 2 to 4 weeks after starting these medications to evaluate efficacy ensures a peak response. The adverse effects of tamsulosin and alfuzosin include dizziness, asthenia, and, in the case of tamsulosin, abnormal
ejaculation.10
The 5 alpha reductase inhibitors, finasteride and dutasteride, shrink prostate tissue by apoptosis and inhibit the enzyme that converts testosterone to
dihydrotestosterone.11,12 Finasteride and dutasteride are available as 5 mg and 0.5 mg dosage forms, respectively, and are administered once daily regardless of meals or time of day. Since the mechanism of action relies on shrinking the prostate tissue, symptom relief takes up to 6 months after starting daily use. Also, these medications should be reserved in most cases for patients with enlarged prostates (> 40 grams), since studies have consistently shown that patients with smaller prostate sizes do not experience significant symptom
relief.11,12 On the positive side, they have been proven to attenuate disease progression, including the need for surgical intervention or development of acute urinary
retention.13
The contraindications and adverse effects of this class are different from the alpha1 receptor inhibitors. Since 5 alpha reductase inhibitors are teratogenic, this class is contraindicated for pregnant females and those of childbearing age. The adverse effects experienced include erectile dysfunction, decreased libido, and ejaculatory disorder. Rarely, patients could also experience gynecomastia or breast
tenderness.11, 12
A final concern with the 5 alpha reductase inhibitors is clinically important. Due to the apoptotic nature of these medications in reducing prostate tissue size, PSA concentrations are usually reduced as well. Therefore, it has been suggested that these medications might interfere with the detection of prostate cancer. However, studies have determined that the PSA can be used to monitor for prostate cancer in the following manner: the PSA level should always be drawn at baseline prior to initiating finasteride or dutasteride. Once the patient has taken the medication for six months, another level should be drawn and multiplied by "2" to maintain sensitivity for prostate cancer detection.
14 Finally, one study was initiated to determine whether finasteride given 5 mg daily versus placebo could attenuate development of prostate cancer.15 Although prostate cancer was attenuated in the medication-using group, the patients who presented with prostate cancer tended to have a more severe form. Therefore, the study was inconclusive regarding any widespread recommendation for using 5 alpha reductase inhibitors for prostate cancer prevention.
A word of caution concerning herbal therapies: although they represent attractive alternatives to the public seeking LUTS relief, recommending use of herbals is problematic. Herbal manufacturers are not tightly regulated and are not generally held accountable for maintaining product consistency. Therefore, neither the mechanism of action nor the efficacy of individual herbals can be confirmed. Although studies compare saw palmetto, in particular, versus placebo and other BPH medications, they are inhibited by a lack of standardization for symptom scores and general use of an open
label.16 Clinically, if patients exhibit symptoms severe enough to request relief (i.e., moderate to severe BPH), they should be offered medication relief rather than herbal
therapy.6
If symptoms are moderate or severe despite maximum use of medications - or, if the patient and clinician have determined that medications would not be beneficial - surgery is another
option.6 In the past, resection of the prostate was the only option, but it is invasive, expensive, and may require a hospital stay. Also, patients are more likely to experience erectile dysfunction adverse effects post-surgery than if a minimally invasive surgery is used. Minimally invasive surgeries include transurethral needle ablation, interstitial laser thermoablation, and transurethral microwave thermotherapy. These types of surgery are more likely to be performed on an outpatient basis and usually have relatively fewer adverse effects. However, prostate tissue can regrow more quickly using minimally invasive surgery as compared to the more invasive
form.17
Implementation of BPH Management into Primary Care Practice
The patient's need for onset of symptomatic relief, degree of prostate enlargement, and tolerability to the medication should all be considered when prescribing BPH medications. Since 2nd generation alpha1 receptor inhibitors can cause blood pressure reduction - and this reduction is increased proportional to dose - these medications should be used for those who can tolerate dose adjustment for full symptom relief. Also, the elderly may be susceptible to falls from the adverse effects, dizziness and syncope. Thus, 3rd generation alpha1 receptor inhibitors may be a better choice for patients with baseline hypotension or
orthostasis.2
If the maximum titration of an alpha1 receptor inhibitor does not yield significant relief of LUTS, a 5 alpha reductase inhibitor may be added. The MTOPS (Medical Therapy of Prostatic Symptoms Trial) study showed an increased efficacy in symptom relief and reduction in disease progression when using both classes compared to either class alone. However, adverse effects are significantly increased when using both classes together, and benefit is most likely for patients with enlarged
prostates.13
Other factors also contribute to increased LUTS. Stopping or decreasing the dose of certain concomitant medications could alleviate LUTS, such as with nasal decongestants like pseudoephedrine (stimulates prostate alpha receptors), anticholinergics like antihistamines and tricyclic antidepressants (increase urination frequency), and diuretics. In particular, patients who use twice daily diuretics could combine their daily dose into morning administration only, thus preventing significant nocturia. Finally, clinicians should talk to patients about "common sense" measures, such as eliminating water, coffee, and tea consumption after their evening
meals.2
Conclusions
The impact of untreated or undertreated LUTS on quality of life is enormous. Thus, this disease state should be treated as thoroughly as other chronic disease states, such as diabetes, hypertension, and heart failure. After ruling out other causes of BPH such as prostatitis and prostate cancer, baseline tests (i.e., PSA, DRE, symptom score index questionnaire) should be obtained. By selecting the most appropriate medication (or non-medication) therapy and maintaining a vigilant examination on successive patient
visits, the clinician can reduce LUTS and considerably improve their patients' quality of life.
References
1. Dull P, Reagan RW, Bahnson RR. Managing benign prostatic hyperplasia. Am Fam
Physician 2002; 55:77-84, 87-8.
2. Sherman JJ. Prostate Health Considerations: the pharmacist's role. Pharmacy Times
2005;71(8):75-85.
3. Cohen H, Levy SB. Newer pharmacotherapeutic approaches to the management of benign
prostatic hyperplasia. US Pharmacist 2002; 27(12):73-84.
4. Jacobsen SJ, Girman CJ, Lieber MM. Natural history of benign prostatic
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5. Sherman JJ. Benign Prostatic Hyperplasia. Pharmacotherapy Self-Assessment Program:
Men and Women's Health. 5th Edition. American College of Clinical Pharmacy 2003; 181-206.
6. AUA Practice Guidelines Committee. AUA guideline on management of benign prostatic hyperplasia (2003). Chapter 1: diagnosis and treatment recommendations.
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8. Narayan P, Tewari A. Overview of alpha-blocker therapy for benign prostatic hyperplasia.
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9. ALLHAT Collaborative Research Group. Diuretic versus alpha-blocker as first-step
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11. Roehrborn C, Boyle P, Nickel J, et al. Efficacy and safety of a dual inhibitor of 5 alpha reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia.
Urology 2002; 50(3):434.
12. Wilde MI, Goa KL. Finasteride: an update of its use in the management of symptomatic benign prostatic hyperplasia. Drugs 1999; 57(4):557-81.
13. McConnell JD, Roehrborn CG, Tautista OM, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia.
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Urology 1998; 52:195-201.
15. Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the
development of prostate cancer. N Engl J Med 2003; 349(3):215-24.
16. Dvorkin L, Song KY. Herbs for benign prostatic hyperplasia. Ann Pharmacother
2002; 36:1443-52.
17. Blute ML, Larson T. Minimally invasive therapies for benign prostatic hyperplasia.
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