Provider Update
Volume 16, Issue 1
February 1999
New Recipient Billing Identification Number
Medicaid recipients now have a Plastic Swipe ID Card which is encoded with a 16 digit Card Control Number (CCN) containing the lead digits of 777. The purpose of this card number is to access Medicaid eligibility, benefit, and service limits information. The CCN should never be used for billing with the exception of Pharmacy POS. Claims submitted with this number will deny.
The Medicaid recipient billing identification number presently assigned to recipients is a 13 digit number which includes parish and eligibility type codes within the first four digits. The use of this �smart� number for billing Medicaid claims has caused difficulty for the Provider community. Each time a recipient moved or changed basis of eligibility a new number was issued. In spite of our best efforts to link multiple ID numbers to a recipient to whom more than one number was issued, we have continued to have problems. Many claims have denied for lack of eligibility, name/number mismatch, pre-certification, or prior authorization for this reason.
Providers have had the burden of locating another identification number with which to bill and then resubmitting claims for processing. Beginning July 6, 1999, a permanent 13 digit billing number will be assigned to each Medicaid recipient. Although the Permanent number will frequently look the same as the Medicaid recipient billing identification number presently assigned to a recipient, this number will not denote an information related to parish or eligibility type. Each recipient on file as of 6/30/99 will have his/her most current 13 digit ID number selected as his/her permanent number. Recipients added to the file 7/99 and after will be assigned one new permanent number.
This does not mean that the other ID numbers issued to recipients cannot be used to bill. In fact, when billing for services which have been pre-certified or prior authorized it will be necessary to bill using the number under which the pre-cert or prior authorization was issued. We encourage Providers, beginning 7/99 to make note of the identification number confirmed or obtained from the Unisys REVS telephone inquiry , or the MEVS plastic id card swipe inquiry as this will be the permanent number. You will still need to access REVS or MEVS to verify eligibility.
We hope that the Provider community will find this change a positive one which will remove the burden of determining what 13 digit ID number to use when requesting pre-cert, prior authorization, or claim submission. Every effort is being made to make this a smooth transition. Thank you for your patience and participation in Louisiana Medicaid Program.
Warning to Physicians Announced
Louisiana Medicaid�s Program Integrity (PI) Section has uncovered a disturbing billing practice in which entities not enrolled as Medicaid providers are using physician�s Medicaid numbers in order to submit billing for their services. PI has found that some physicians have unknowingly become involved in this fraudulent billing practice and want to raise physician awareness of this practice so that physicians may not become liable for this billing.
This scam is put into motion when a non-Medicaid enrolled entity hires an enrolled physician provider, and then uses that physician�s Medicaid number for billing. These fraudulent billings are detected by audits, which find unusual aberrant billing patterns; for example, inappropriate testing may be detected. Physicians risk being drawn into a long, complicated fraud investigation and risk criminal prosecution. Please be careful with your Medicaid provider number. The number assigned to an individual provider belongs to that provider, only, and he/she is the only person authorized to report changes regarding that number to the Medicaid provider file personnel. If you are aware of a suspicious practice, please call our fraud line at 1-800-488-2917.
Hospital Pre-Cert Process Changes Implemented
As you know, according to our Pre-Admission Certification rules published in 1994, a hospital must request an extension of inpatient hospital days on or before the last day of the approved stay. Many hospitals are submitting a request on the day after the last approved day which is not timely according to the rule. In order to assist you in this matter and to improve the process we are implementing the following
changes:
1. The Department of Health and Hospitals will now allow hospitals to submit an extension request on the expected discharge date instead of the day before the expected discharge
date.
2. In situations when a hospital is denied an extension request based on timely submittal of the medical information requested by Unisys, and the patient is still in the hospital, the Department of Health and Hospitals will allow hospitals to request to re-open the Pre-Cert case under a new Pre-Cert number when the hospital submits current documentation to be reviewed as long as the patient continues to be an inpatient. A new Pre-Cert number will be issued with the admit date being the date that the hospital submits current documentation to the Unisys Pre-Cert Department. The days that were denied may be appealed through the DHH appeal process using the Pre-Cert number under which the days were denied.
Funding of Chemotherapy Injections
The Bureau of Health Services Financing will fund the following chemotherapy injections effective with date of service February 1,
1999
| Chemotherapy Injection |
Diagnoses |
Code |
Fee |
| Fludarabine(aka Fludara)50mg |
Leukemia and Lymphoma |
J9185 |
$198.58 |
| Irinotecan(aka Camptosar) 20mg |
Colon Cancer |
J9191 |
$98.79 |
| Topotecan(aka Hycamtin) 4mg vial |
Ovarian Cancer |
J9350 |
$490.77 |
| Trastuzumab(aka Herceptin) 1mg |
Breast Cancer |
J9192 |
$4.60 |
|
These drugs will be administered by infusion and the dosage varies according
to the patient's weight.
Untimely Crossover Claims Recovery Project Announced
If you received a claim listing and message advising that you were wrongly paid and that the amount of your payment(s) would be withheld from the 12/22/98 checkwrite, please disregard the notice and listing. The run contained claims originally voided in a Duplicate Recovery Project (remittance date 3/03/96) which, when appropriate , were refiled by the providers. We have eliminated these repayments, sent all providers new listings, and set a new date for recovery.
Medicare Part A Claims Clarified
We have recently been asked for a clarification in billing Medicare Part A only claims. If the recipient has Medicare Part A only coverage, the hospital should submit an inpatient claim, including the ancillary charges, to its Medicare intermediary for reimbursement. The claim will automatically cross over to Medicaid for payment of the co-insurance and deductible amounts for the inpatient stay.
A revision to page 10-31 of the Hospital Manual will be issued in the near future.
�Prudent layperson� Standard Defined
Provisions of the Balanced Budget Act of 1997 require that emergency services be covered without regard to prior authorization for Medicaid recipients who are enrolled in managed care programs such as the CommunityCARE program operated by the State of Louisiana. Emergency services are defined in the Balanced Budget Act of 1997 as covered inpatient or outpatient services needed to evaluate or stabilize an emergency medical condition, as found to exist using the �prudent layperson� standard as defined below:
�A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that a prudent layperson who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, serious impairment of bodily functions or serious dysfunction of any bodily organ or part.�
As a CommunityCARE provider, please begin immediately to use this �prudent layperson� standard when reviewing any request for authorization of emergency services for any CommunityCARE recipient. If you have questions regarding this matter, please contact the CommunityCARE office at (225)342-1304.
Recipient Calls to Provider Relations Discouraged
The Provider Relations Inquiry Unit was established to receive telephone inquiries from providers, not recipients. We do not have access to information that could benefit recipients. Therefore, we ask that providers not issue our telephone numbers to Medicaid patients. Recipient inquiries tie up the inquiry lines and prevent the processing of provider inquiries in an efficient and timely manner.
If recipients have problems or questions concerning eligibility or claim concerns, it is appropriate to refer them to their case worker at the parish office.
If providers have problems with claims processing or payment, they should contact Unisys Provider Relations for assistance. IT IS NEVER ACCEPTABLE TO GIVE A RECIPIENT YOUR PROVIDER NUMBER FOR THEIR USE IN CONTACTING OUR OFFICE CONCERNING CLAIMS PAYMENT/PROBLEMS.
Third Party Liability Billing Clarified *
Federal regulations and applicable state laws require that third-party resources be used before Medicaid is billed. Third-Party refers to those payment resources available from both private and public health insurance and from other liable sources, such as liability and casualty insurance, that can be applied toward the Medicaid recipient�s medical and health expenses. Providers should check the recipient�s TPL segment to verify that the third-party liability(TPL) codes are accurate according to the TPL listing and the name of the third-party insurance carrier. (TPL carrier code listings are mailed by Unisys to providers twice yearly � in January or February and in July or August.) This information is also supplied through the MEVS and REVS automated eligibility systems.
If this code is not correct, the provider should instruct the recipient to contact his/her parish worker to correct the file, especially if the insurance has been canceled. The provider may also initiate updates to the TPL file by submitting a cover letter of explanation, along with a letter or EOB of termination or cancellation (containing specific recipient and date information) to Unisys Provider Relations Correspondence Unit. Claims submitted for payment will deny unless the insurance coverage is noted on the claim with the appropriate TPL code or unless a letter explaining the cancellation of the insurance from the carrier is attached to the claim.
The lack of a third-party TPL code segment does not negate the provider�s responsibility for asking the recipient if he/she has insurance coverage.
When billing Medicaid after receiving payment from a TPL (except Medicare), the provider must bill a hard-copy claim. The six-digit carrier code from the TPL segment must be entered in the appropriate block and any payments received must also be entered as prior payments. The EOB from the other insurance should be attached to the claim form and the dates of service, procedure codes and total charges must match, or the claim will deny. All Medicaid requirements such as precertification or prior authorization, must be met before payment will be considered.
Claims submitted where the billing information does not match the EOB should be sent to Provider Relations with a cover letter explaining the discrepancy. Such instances would include payment for dates not precertified by Medicaid and privately assigned procedure codes not recognized by Medicaid.
* Note: Pharmacy provider and certain EPSDT providers follow the Medicaid Pay and Chase Policy concerning TPL coverage.
Provider Relations Inquiry Unit
The Provider Relations inquiry staff strives to respond to provider inquiries quickly and efficiently. The purpose of the Provider Relations Inquiry Unit is to assist providers who have questions concerning billing claims, printed policy, procedural issues, or claims processing problems.
Unisys Provider Relations responds to inquiries concerning particular claims when the provider has reconciled the Remittance Advice (RA) and determined that the claim has denied, pended, paid or been rejected prior to entry into the system. It is not possible for Unisys Provider Relations to take the place of the provider�s weekly Remittance Advice by checking the status of numbers of claims on which providers, billers or collection agencies are checking.
In situations where providers choose to contract with outside agencies to bill claims and reconcile accounts, it is the provider�s responsibility to provide the contracted agency with copies of RA�s or other billing related information in order to bill the claims and reconcile the accounts. When providers or contractors are attempting to reconcile old accounts, if RA�s are not available through the provider, it may be necessary for the provider to arrange to obtain a claims history which is available for a fee through Unisys Provider Relations. Please contact Unisys at (800) 473-2783 or (225) 924-5040 for information on how to order a history.
To expedite any and all inquiries, please have your Medicaid provider number and all of the necessary information available when you call.
Electronic Claims Submission
Electronic media claim submission is an alternate method of submitting Medicaid claims to Unisys. With electronic media, a provider or a third party contractor (billing agent) submits Medicaid claims to Unisys on a computer encoded magnetic tape, diskette or via telecommunications.
Each claim undergoes the editing common to all claims, e.g., verification of dates and balancing. Each type of claim has unique edits consistent with the requirements outlined in the provider manuals. All claims received via electronic media must satisfy the criteria listed in the manual for that type of claim.
Advantages of submitting claims electronically include increased cash flow, improved claim control, decrease in time for receipt of payment, automation of receivables information, improved claim reporting by observation of errors and reduction of errors through pre-editing claims information.
Each reel of tape, diskette or telecommunicated file submitted for processing must be accompanied by a submission certification form signed by the authorized Medicaid provider or billing agent for each provider whose claims are billed using electronic media. The certification must be included in each tape or diskette submitted. Providers submitting by telecommunications must submit this certification within 48 hours.
If you are not in possession of the certification forms, you should call the EMC Department at Unisys and request an EMC packet. The packet includes all the different types of certification forms required. Third-party billers are also required to submit a certification form. You should select the certification form in the packet that applies to your particular provider type and make copies as necessary for submission to Unisys. Contact the EMC Department at Unisys at (225) 237-3303. The mailing address for the EMC Department at Unisys is P.O. Box 91025, Baton Rouge, LA 70821.
New Local Phone Number for REVS
A new, local telephone number has been added to the Recipient Eligibility Verification System (REVS) for local provider use. The new number is 216-REVS (7387). If you are located in the Baton Rouge area, please begin using this number rather than (800) 776-6323. This will allow more long distance providers accessing REVS to use the toll free number for eligibility verification. We hope this new number will be a positive and effective addition for your staff.
REVS Reminders: Please remember to use eight-digit numbers (dates of birth, dates of service, etc.) when accessing information using REVS. Also, please remember if you are using a 13 digit recipient number to access REVS, only recipient identification numbers which are current within the last 12 months will allow you to access REVS eligibility information. If you are using a number that is not valid within the last 12 months, the system will respond stating the recipient is not on file.
DHH Accepting Nominations for DUR Committee
The Department of Health and Hospitals is currently accepting pharmacist nominations for the Region 1 Drug Utilization Review Committee. The Committee consists of three pharmacists and one physician who meet monthly to review profiles of drug usage from a therapeutic perspective and to clarify or send information to the medical community. Currently one pharmacist opening is available. We are requesting that the nominees be Louisiana Medicaid providers and practice in at least one of the following parishes:Jefferson St. Tammany Orleans Tangipahoa Washington St. Bernard Plaquemines Prospective committee members must have time available to meet monthly for one to three hours and must meet the following requirements:Pharmacy degree from an accredited U.S. pharmacy schoolLicensed to practice in Louisiana as a pharmacistNo previous sanctions from the State of Louisiana Please print or type your nominations on this form in the space provided below (brief resume appreciated) and return the form as soon as possible
to:
Unisys: Louisiana Medicaid
8591 United Plaza Blvd., Suite 300
Baton Rouge, LA. 70809
ATTN: S. DELAVILLE
_______________________________________________
LMMIS REGION ONE DRUG UTILIZATION REVIEW COMMITTEE
NAME:____________PHONE:_______________ADDRESS:_____________ PARISH:_______________EMPLOYER:______________I am nominating the above mentioned for consideration as a member in the LMMIS REGION ONE DRUG UTILIZATION REVIEW COMMITTEE.
SIGNATURE:____________PARISH:_______________________________
Prescription Payment Responsibility of Skilled Nursing Facility
When a resident of a skilled nursing facility is in Medicare payment status, payment for prescription medications becomes the responsibility of the facility as prescription services are included in the per diem paid by Medicare. When the facility is paying for the medications, the facility has a right to contract with a pharmacy of its choice. If the resident converts back to Medicaid, at that point the resident may exercise his right to utilize the pharmacy of his choice.
A skilled nursing facility may choose to contract with whomever it wishes in order to obtain medications for the Medicare residents.
When Medicare is the primary and Medicaid is the secondary payor for a resident, Medicare regulations govern the reimbursement. The same holds true for Medicare as the primary with no Medicaid as the secondary.
Correct Phone Number for PCS Prior Authorization
You recently received a notice concerning the implementation of Prior Authorization for PCS services. Page 3 of this notice listed an incorrect phone number for Unisys Provider Relations. The correct numbers are (800) 473-2783 or (225) 924-5040.
Hepatitis A Vaccine Code Added to Reimbursable List
Hepatitis A vaccine code has been added to the list of codes reimbursable to Certified Nurse Practitioners for children ages 0 through 20. The administration fee of $ 9.45 will be funded effective with date of service July 14, 1998.
Certified Nurse Practitioner services are reimbursed at 80% of the current fee on file, with the exception of immunizations, which are reimbursed at 100% of the fee on file.
LADUR Education Article
Erectile Dysfunction
By Edwin Adams, Pharm.D.Northeast Louisiana University School of PharmacyDivision of Clinical Pharmacy Practice
Issues
- Erectile Dysfunction may be the result of treatable
pathologies.
- There are various pharmacological treatment options currently
available.
- The potential results of prescribing Viagra in patients at clinical risk from cardiovascular effects
Since the introduction of Viagra in March of 1998, erectile dysfunction (ED) has been discussed more openly and a greater number of patients have sought treatment for this condition. This Provider Update article, Part 1 of a 2-part series, will briefly review the etiology and pathology of ED, along with the pharmacological treatment options currently available, drug interactions and therapeutic considerations.
In 1992, the Consensus Conference at the National Institutes of Health formally defined erectile dysfunction as the inability to achieve and maintain a penile erection satisfactory for sexual intercourse. This condition should not be confused with ejaculatory disorders or those conditions related to arousal. Because erectile dysfunction is more common in older men does not mean that it is a normal part of aging. There may be treatable pathologies, such as hypertension, atherosclerosis, or psychological problems, in the differential diagnosis. Arthur Burnett, M.D., Assistant Professor of Urology at the Johns Hopkins University Hospital in Baltimore, commented, �Twenty five years ago, it was believed that 75% to 80% of presentations resulted from psychological disturbances. Now we believe that the reverse is true.�
Erections are the result of blood vessels feeding the erectile tissue undergoing vasodilation. The smooth muscle tissue comprising the trabecular meshwork, or the erectile tissue (the corpus spongiosum and the corpora cavernosa) undergoes relaxation. The sequence leading to smooth muscle relaxation includes nerve impulses in the brain, spinal column, and penis, and responses in muscle, fibrous tissues, veins, and arteries in or near the corpora cavernosa. Erection occurs when the relaxed muscles allow the corpora cavernosa to fill with excess blood fed by the arteries, causing expansion and rigidity. At the same time, expansion compresses the venules against the wall of the penis, preventing blood outflow.
There are several chemical factors involved in the erectile process, including hormones, neurotransmitters, and substances locally released from the endothelial or smooth muscle components of the erectile tissue. Recently, the principal mediator of the erectile process was identified as nitric oxide (NO), a vital component of smooth muscle relaxation. NO is produced in the endothelial cells of the cavernous sinusoids, and exerts its effect through the second messenger cyclic guanosine monophosphate (cGMP).
Damage to the arteries, smooth muscles, and fibrous tissues is the most common cause of erectile dysfunction. This damage may result from prostate, colon, or bladder surgery; or may result from such diseases as diabetes, kidney disease, chronic alcoholism, multiple sclerosis, atherosclerosis, and vascular
disease.
Pharmacologic Options:
Recognition of the organic pathologies associated with erectile dysfunction has resulted in a few successful therapies. Before the spring of 1998, only alprostadil-containing products had received approval for the treatment of erectile dysfunction. However, many products touting erectogenic effects have not been studied with controlled clinical trials.
The use of intracavernosal injections of vasoactive agents has contributed significantly to the management of erectile dysfunction. These agents include alprostadil, phentolamine, and papaverine. The mechanisms of action include stimulation of the vascular component of penile erection, the inhibition of sympathetic tome and the relaxation of the corporeal smooth muscle. These drugs are often used in combination providing synergy with few adverse effects. Effectiveness is achieved in approximately 90% of patients.
Alprostadil is a synthetic prostaglandin E1 with a-adrenergic blocking properties. Single injections induce erection in approximately 70% of patients with erectile dysfunction of mixed etiology. It is rapidly removed from local and systemic circulation with 60 minutes of injection. The most common adverse reaction is penile pain, occurring in at least 35% of patients.
Papaverine is an opium alkaloid that inhibits phosphodiesterases, causing an attenuation of a-1-adrenergic mediated smooth muscle contraction. This facilitates smooth muscle relaxation in the sinusoids. Papaverine alone achieves erectile function in 40% to 60% of cases. However, it is generally used in combination with other vasoactive substances due to its adverse effect profile. Due to its slow removal from local and systemic circulation, papaverine may cause priapism, a sustained erection for longer than four to six hours. There is also a risk of hepatotoxicity and corporeal fibrosis. As a single agent, doses of 10mg to 60mg are required, but with combination therapy, lower doses of 3mg to 5mg are effective.
Phentolamine is an a-1 and a-2 adrenergic receptor blocker that dilates arterial vessels and interferes with the sympathetic inhibition of erection. This drug is only used in combination therapy with papaverine and alprostadil. The most common adverse effects are orthostatic hypotension and tachycardia.
Adverse effects resulting from intracavernosal injection include a 5% risk of priapism, which can result in erectile tissue damage. Fibrosis, urethral damage, pain after injection, local infection, and hematomas can occur with single or combination drug therapy. Contraindications to intracavernosal injections include hemoglobinopathy, bleeding disorders, penile implants, anatomical deformations of the penis, Peyronie�s Disease, and predisposition to priapism (multiple myeloma, leukemia, sickle-cell anemia). More than 50% of patients discontinue intracavernosal injections within 12 months due to a loss of interest, complications or decreased efficacy.
There is an alternate method of delivery for alprostadil. The MUSE (Medicated Urethral System for Erection) transurethral device allows for alprostadil gel to be inserted into the tip of the penis using an applicator. Effectiveness ranges from 40% to 65%. Compared with intracavernosal injections, higher concentrations of drug reach the systemic circulation, resulting in more frequent hypotensive episodes. Priapism and penile fibrosis are less likely, but 10% of patients still experience penile pain and 5% of users may experience urethral bleeding. As can be expected, the MUSE system of administration is more expensive to use than intracavernosal injections.
In March of 1998, sildenafil (Viagra�) was approved for the treatment of erectile dysfunction. Sildenafil is a potent inhibitor of Type-V phosphodiesterase, the enzyme responsible for cGMP metabolism in the corpus cavernosum. Therefore, sildenafil exerts its action through enhancement of cGMP, the second messenger of NO. The end result is the relaxation of smooth muscle lining the cavernosum.
After oral administration, sildenafil achieves maximum plasma concentrations in about 60 minutes. Sildenafil does not appear to increase heart rate or blood pressure. Penile erection with sildenafil requires sexual stimulation; otherwise the agent has no effect at recommended doses. In fixed-dose trials, improvements in erections were reported in 82% of men taking 100mg, 74% taking 50mg, and 63% taking 25mg. The recommended dosage of sildenafil is 50mg taken approximately one hour before sexual activity. The dosage may be adjusted up to 100mg or down to 25mg as needed. The maximum recommended dosing frequency is once per day. Adverse effects include headache, flushing, and dyspepsia. Visual disturbances (color discrimination) have been reported in 3% of patients taking sildenafil. No cases of priapism have been reported. Sildenafil is contraindicated in persons who are currently using organic nitrates in any form, as sildenafil may potentiate the hypotensive effects of nitrates. Elderly patients and those with significant renal or hepatic impairment may show a reduced clearance of sildenafil.
Other oral therapies for erectile dysfunction include yohimbine, apomorphine, and phentolamine. Yohimbine has been the most widely used; however, this agent may be no more effective than placebo. Oral apomorphine is currently in the final stages of development. Oral phentolamine is expected to be indicated for mild erectile dysfunction.
Drug Interactions and Therapeutic Considerations with
Sildenafil
The American College of Cardiology (ACC), in conjunction with the American Heart Association (AHA), has published an expert consensus document titled, �Use of Sildenafil (Viagra�) in Patients with Cardiovascular Disease.� The following information was adapted from that expert consensus
document.
Prescribing Sildenafil to Patients at Clinical Risk
Sildenafil is absolutely contraindicated in patients undergoing any long-acting nitrate drug therapy or using short-acting nitrates because of the risk of developing potentially life-threatening hypotension.
If a patient has stable coronary disease, is not taking a long-acting nitrate, has short-acting nitrate use as the only contraindication to sildenafil, and does not appear to need the nitrate on a consistent basis, the physician and the patient should carefully weigh the risks and benefits of sildenafil treatment. If the patient requires nitrates for mild or moderate exercise limitation, sildenafil should probably not be used.
All patients taking organic nitrates, even if they have not asked for Viagra, should be informed about the nitrate-sildenafil hypotensive interaction. There is a substantial potential for patients to obtain Viagra from another physician, a friend, or through the �black market,� circumventing healthcare providers who could offer appropriate caution. Because sildenafil also potentiates the hypotensive effect of an inhaled form of nitrate, such as amyl nitrate or poppers, the concurrent recreational use of poppers and sildenafil could result in sudden and marked hypotensive response that could be serious or fatal. The interaction may be more pronounced in patients taking protease inhibitors concurrently (eg, indinavir, ritonavir, nelfinavir, and saquinavir.)
Similarly, patients must be warned of the contraindication of taking sildenafil in the 24-hour time interval after taking a nitrate preparation, including sublingual nitroglycerin. The administration of sildenafil to a patient who has taken a nitrate in any form in the preceding 24 hours is contraindicated.
Although firm data are lacking, pre-Viagra treadmill tests to assess the presence of stress-induced ischemia in patients with overt and covert coronary artery disease can guide the patient and physician relative
to the risk of cardiac ischemia during sexual intercourse. If the patient can achieve >=5 to 6 METS on an ETT without demonstrating ischemia, the risk of ischemia during coitus with a familiar partner, in familiar settings, with out the added stress of a heavy metal or alcohol ingestion, is probably low. We wish to stress that the physical and emotional stresses of sexual intercourse can be excessive in some people, particularly those who have not performed this activity in some time and who are not in good condition. These stresses themselves may produce acute ischemia or precipitate myocardial infarction. Such patients should be advised to use common sense and to moderate their physical exertion and their emotional expectations as they begin their experience with taking Viagra.
If patients are taking a combination of antihypertensive medication, they should be cautioned about the possibility of sildenafil-induced hypotension. Because both venous and arterial vasodialation occur with sildenafil, initial monitoring of the blood pressure with the institution of Viagra use would identify patients with an undesired hypotensive blood pressure response. This is an area of particular concern for the patient with congestive heart failure who has a borderline low blood volume and a low blood pressure status as well as for the patient who is following a complicated, multidrug, antihypertensive therapy
regimen.
Management of Acute Cardiac Ischemia Syndromes With Patients on
Viagra�
The physician should try to establish the time of the last dose of sildenafil. Definitive evidence is currently lacking, but it is possible that a precipitous reduction in blood pressure may occur over the initial 24 hours after a dose of sildenafil. Administration of nitrates in this time interval should be avoided. In the event that nitrates are given after sildenafil administration, it is essential to have the capability to support the patient with fluid resuscitation and alpha-adrenergic agonists if needed. After 24 hours, the administration of a nitrate may be considered, but once again, appropriate caution with careful monitoring of initial dosages must be used. In patients in whom the half-life of sildenafil may be prolonged, such as in renal and hepatic dysfunction or patients concurrently taking a potent CYP 3A4 inhibitor, a more extended period of time from sildenafil administration to the time of nitrate administration may be required. In patients with recurring mild angina after sildenafil use, other nonnitrate antianginal agents, such as beta-blockers, should be considered.
Patients taking sildenafil who have an acute myocardial infarction should be treated in the usual manner as described in the ACC/AHA clinical practice guidelines including, where appropriate, primary angioplasty or thrombolytics. The only difference is that nitrates are contraindicated for these patients. If the patient had already used nitrates and sildenafil together, the acute myocardial infarction may have been caused by the low diastolic perfusion pressure of the coronary circulation. Blood pressure support may be sufficient to prevent further myocardial damage if no acute plaque rupture is present.
In patients with unstable angina, therapy should include only nonnitrate antianginal medications, but should otherwise adhere to principles established in the clinical practice guidelines available from
the Agency for Health Care Policy and Research. to date, there is no evidence of significant interactions between sildenafil and heparin, beta-adrenergic blockers, calcium channel blockers, narcotics, or aspirin. These agents can be used as appropriate. After 24 hours, nitrates may be administered if close monitoring is provided and proper facilities are available for fluid and vasopressor support.
Treatment of the Hypotensive Patient With Inadvertent Viagra� Nitrate
Combination Effect
In patients who inadvertently received nitrates while taking sildenafil and who manifest a severe hypotensive response, nitrate and nitroprusside (ie, NO donor) therapy should be immediately stopped. Depending on clinical circumstances, any of the following therapies should be considered alone or in combination:
� Placing the patient in Trendelenburg position;
� Aggressive fluid resuscitation; � Judicious use of an intravenous -adrenergic agonist, such as phenylephrine
(Neosynephrine�)
� An alpha- and beta-adrenergic agonist (norepinephrine) for blood pressure support with the realization that this could exacerbate or lead to an acute ischemia syndrome;
� Intraaortic balloon counterpulsation.
Limitations and Unresolved Issues
Expert Consensus Documents are often written in circumstances in which the evidence base and experience with the technology or practice are limited. This is clearly the case with Viagra. The evidence base had significant limitations, and many important issues remain unresolved. Of special significance to the concurrent report is the fact that the preapproval clinical trials of Viagra excluded certain high-risk groups of patients with significant cardiac disease (ie. patients with heart failure, patients with myocardial infarction or stroke within 6 months, or patients with uncontrolled hypertension) or patients with blood pressures of <90/50 or 170/100 mm Hg. More research needs to be done to assess the specific risks of Viagra use among these cardiovascular patients.
The authors of this Expert Consensus Document identified a number of other unresolved issues that could affect clinical management of the cardiovascular consequences of sildenafil use, including the following:
� Interaction with nonaspirin antiplatelet agents (eg, ticlopi dine, clopidogrel, and dipyridamole).
� Interaction with other PDE inhibitors, including specific PDE inhibitors (eg, milrinone, vesnarinone, and enoximone) and nonspecific PDE inhibitors (eg, theophylline, dipydamole, papaverine, and pentox- fylline).
� Central nervous system effects of sildenafil (PDE5 is present in the brain).
� Hypotensive effects with sildenafil alone in high-risk cardiac patients (severe heart failure).
� Musculoskeletal effects (myalgias with chest pains that could be confused with angina).
As more evidence is accumulated, the ACC will consider an update of the Expert Consensus Document.
This clinical discussion of ED and Viagra, Part 1, will be followed by Part 2 in the April 1998 issue of the Provider Update. Part 2 will use claims data to demographically profile Medicaid recipients who received prescriptions for any of several of the most common drug treatments for ED, as well as comorbid contributory conditions and concurrent drug therapies. The upcoming article will also report on the impact of Viagra and the limit of 6 per month on utilization and expenditures for ED treatment.
References
Matsumoto AM. The Testis and Male Sexual Function. Cecil's Textbook of Medicine, 19th Edition. W.B. Saunders Company. Philadelphia, USA. Pages
1336-2095.
Boolell M, Allen MJ, Ballard SA, et al. Sildenafil: An Orally Active Type 5 cCclic GMP-Specific Phosphodiesterase Inhibitor for the Treatment of Penile Erectile Dysfunction. International Journal of Impotence Research 8(2):47-52, 1996 June. Accessed via www.medscape.com on
10/19/98.
Christensen D. Impotent Men Do Not Know There Is Treatment. Medical Tribune: Internist and Cardiologist Edition; 38(2))L 1997. Jobson Healthcare Group. Accessed via www.medscape.com on
10/19/98.
Demott K. Oral Drugs Allow Simpler Treatment of Impotence. Clinical Psychiatry News; 26(1):28, 1998. International Medical News Group. Accessed via www.medscape.com on
10/19/98.
Viagra(r) (sildenafil citrate). Patient Package Insert, 1998 Pfizer, Inc. Printed May 1998. Accessed via www.viagra.com on
10/19/98.
FDA Talk Paper. New Drug: Viagra. U.S. Department of Health and Human Services, Rockville, MD. Accessed via www.pharmacistsle ter.com on
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