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The elderly population is at increased risk for potentially inappropriate medication use due to age-related changes to their metabolism, the presence of multiple co-morbid disease states, and extensive prescription and over-the-counter (OTC) drug use. Drug-related adverse events result in approximately 30 percent of hospital admissions. Medication-related problems have been estimated to cost $76.6 billion dollars within the ambulatory care population.  Community Care Rx (CCRx) is committed to cost-effective and safe medication use with a special emphasis on our elderly patient population.

The widely accepted Beers Criteria, recently updated in 2003, identifies 48 medications or individual classes of medications to avoid in patients over age 65 due to potential concerns of adverse events and 20 diseases/conditions and medications to be avoided in older adults. Support for these recommendations is incorporated in the CCRx formulary, including use of quantity limits, prior authorization, and quality assurance programs. These approaches in conjunction with pharmacist counseling and therapeutic interventions help ensure appropriate medication use for CCRx members.  Following is a discussion of four medications/classes included in the Beers Criteria.  Additional medications will be featured in future newsletters.

Antiplatelet Agents

• The formulary does not include ticlopidine (Ticlid*), as this agent has been implicated in severe hematological adverse effects (thrombocytopenia, aplastic anemia, neutropenia, thrombotic thrombocytopenic purpura).  Intensive CBC monitoring is required in patients maintained on ticlopidine therapy.
• The use of ticlopidine should be reserved for patients failing, intolerant of, or allergic to aspirin, Plavix, or, Aggrenox therapy.

NSAIDs

• Long-term use of full dosage and longer half-life agents such as ketorolac, indomethacin, oxaprozin, piroxicam, and naproxen have the potential to produce GI bleeding, high blood pressure, and heart failure.
• Ketorolac tablets should be avoided in the elderly due to gastrointestinal toxicity.
• Alternatives to NSAIDs such as acetaminophen or opiates for severe pain should be considered.
• NSAIDs with lower GI toxicity include etodolac, nabumetone, and salsalate.  As all NSAIDs have the potential to cause GI toxicity, established risk factors for GI toxicity such as advanced age (> 65 years); prior peptic ulcer disease or prior peptic ulcer related GI bleeding; concomitant severe illness; concomitant medications (corticosteroids, aspirin, anticoagulant, or antiplatelet therapy) should be taken into consideration  when considering NSAID therapy.  Use of gastroprotective therapy (e.g., omeprazole 20 mg or misoprostol) should be recommended in combination with an NSAID when clinically appropriate.
• The following CCRx limits apply to high-risk NSAIDs:
  
  • ketorolac (Toradol*):  Quantity Limit: 5 day supply (20 tabs or 20 mL of 15 mg/mL inj) per 30 days
  • indomethacin (Indocin*):  Quantity Limit:  42 caps per 30 days
  • indomethacin (Indocin SR):  Quantity Limit: 28 caps per 30 days
  • oxaprozin (Daypro*):  Prior Authorization Required
    
  • piroxicam (Feldene*):  Prior Authorization Required

Narcotics

• Meperidine (Demerol*) can result in seizures and other adverse effects due to impaired renal clearance in the elderly.
• Propoxyphene (Darvon*, Darvocet*) has not been shown to provide greater pain control than acetaminophen but is limited by narcotic-like side effects.
• Pentazocine (Talwin*)  is not included on formulary due to increased risk of CNS effects as compared to alternate analgesic drugs.
• Judicious use of alternate narcotic analgesics (e.g., morphine, oxycodone) for short periods of time (due to risk of respiratory depression, sedation, and dependency) in combination with non-pharmacological pain modalities should be recommended for pain management in the elderly population.

Muscle Relaxants

• Anticholinergic side effects, sedation, and weakness limit the tolerability of muscle relaxants and antispasmodic drugs in the elderly. Additionally, their safety and effectiveness in doses tolerated by the elderly is not well documented.
• For patients requiring a muscle relaxant, use should be limited to periods of two weeks or less for acute muscle pain.
• The following CCRx limits apply to the following muscle relaxants included in the Beers list of high risk medications:
  • methocarbamol (Robaxin*):  Quantity Limit: 90 tabs/ 30 days
  • carisoprodol (Soma*):  Quantity Limit: 40 tabs/30 days
  • chlorzoxazone (Parafon Forte*):  Quantity Limit: 40 tabs/ 30 days
  • cyclobenzaprine (Flexeril*):  Quantity Limit: 40 tabs/30 days
  • orphenadrine (Norflex*): Quantity Limit: 30 tabs/30 days
  • orphenadrine with aspirin and caffeine (Norgesic*):  Quantity Limit: 80 tabs/ 10 days
  • orphenadrine with aspirin and caffeine (Norgesic Forte*):  Quantity Limit: 40 tabs/ 10 days

* Brand name provided for reference only.  Generic equivalent products available on formulary.
 

The Pharmacy and Therapeutics Committee has established quantity limitations on certain medications to ensure patient safety and appropriate dosing. Quantity limits are generally based on manufacturer’s recommended dosing guidelines. To minimize disruption during the transition period, CCRx relaxed enforcement of quantity limits.

Beginning March 1, quantity limit edits will be restored for the following medications. 

Quantity Limits (Per 30 Days)
albuterol inhaler:  4 inhalers
albuterol syrup:  480 mL
albuterol tablets:  120 tablets
albuterol unit-dose inhalation solution:  450 mL
albuterol 0.5% inhalation solution:  300 mL
Aranesp vials:  8 vials (4 for 300 mcg/mL vials)
Aranesp prefilled syringes:  8 syringes (4 for 300 and 500 mcg syringes)Atrovent: 2 inhalers
Cialis:  6 tablets
Combipatch:  8 patches
Combivent:  2 inhalers
fentanyl:  16 patches
Flonase:  2 bottles
Foradil:  60 capsules
Lamisil:  30 tablets
Lotronex:  60 tablets
Nasonex:  2 bottles
Niaspan:  500 mg = 90; 750 and 1000 mg = 60 (Niaspan will deleted per CMS effective 4-1-06)
Procrit:  12 vials
Provigil:  30 tablets
Rhinocort Aqua:  2 bottles
Serevent:  60 doses
Spiriva:  30 capsules
Strattera:  60 tablets
Viagra:  6 tablets
Zelnorm:  60 tablets

Pharmacists should work with physicians to change prescription quantities if needed.  The dynamic PA, which overrides ‘PRODUCT NOT COVERED’ rejects, can still be used until further notice for initial non-formulary prescriptions for patients who need a transition supply.

Physicians should request an exception if it is medically necessary to exceed these limits.  The request form and a complete list of CCRx quantity limits are available for download at CCRx.net.
 

Effective immediately, the CCRx Pharmacy Tech Center (PTC) will be open 24 hours a day/7 days a week. A 24/7 operation will improve customer service and assist pharmacies that stay open round-the-clock. PTC representatives can assist with a number of tasks including looking up member ID and group numbers, formulary questions, and answering questions about quantity limits, prior authorization, and step therapy requests.

The Beneficiary Call Center (BCC) is now open to serve your patients from 8 a.m. until 8 p.m. seven days a week in all time zones. Beneficiaries can call 866-684-5353 to enroll in CCRx or inquire about application status, billing, or claims.
 

After the deductible and initial coverage periods of the CCRx Medicare Part D benefit, patients will enter the coverage gap, also referred to as the donut hole, phase of the benefit. A beneficiary reaches this stage of the benefit after $2,250 in total drug spend. During the coverage gap, dual eligible and low income subsidy (LIS) beneficiaries no longer have a $0 copay on generics and will now have a copay for generic drugs of $1-$2 or 15 percent coinsurance depending on the LIS level. Institutionalized full-benefit dual eligible beneficiaries do not have any cost sharing in the coverage gap period. All other regular CCRx beneficiaries will pay 100 percent of the drug cost unless they have supplemental coverage from another payer (e.g., employer wrap-around or State Pharmacy Assistance Program).

It is extremely important to educate your patients about this phase of the benefit to reduce noncompliance and pill-splitting, which could result in even more costly hospitalizations. Patients will be receiving a monthly statement from CCRx that includes their current level of True Out-of-Pocket Costs (TrOOP). Once a beneficiary reaches $3,600 in TrOOP, he/she moves into the catastrophic coverage period which has little to no cost-sharing depending on the beneficiary’s status.

The following is a breakdown of expected cost sharing for CCRx beneficiaries during the coverage gap period by grouping.

• Institutionalized full-benefit dual eligible: no cost sharing
• Group 1 (full benefit duals at or below the federal poverty level-FPL): $1 generic/$3 brand
• Group 2 (full benefit duals above the FPL and low income individuals below 135 percent of the FPL and meeting the lowest asset test): $2 generic/$5 brand
• Group 3 (low income individuals below 150 percent of the FPL and meeting the higher assets test): 15 percent coinsurance for generic and brand
• All other CCRx beneficiaries: 100 percent cost-sharing

The CCRx formulary is designed to offer generic therapeutic equivalents when available. Generic drugs save your patients money and postpone the onset of the coverage gap phase of the benefit. Pharmacists function as risk managers by working with patients and their physicians to safely switch patients to therapeutically equivalent alternatives to brand and preferred brand drugs. As a reminder, the CCRx provider agreements offer higher dispensing rates for generic medications, creating a win-win situation for both pharmacists and their patients.

The state of Pennsylvania chose Community Care Rx as one of six plans to receive auto enrollments from the Pharmaceutical Assistance Contract for the Elderly (PACE) and PACE Needs Enhancement Tier (PACENET). With more than 200,000 participants, PACE and PACENET combined are one of the nation’s largest State Pharmacy Assistance Programs (SPAP). MemberHealth, plan sponsor for CCRx, worked as a team with community pharmacists during the entire process from the initial proposal to the final decision. “There is no doubt that the support of the community pharmacists played a major role in our success,” said Rick Kelley, Director of Sales for MemberHealth.
 

As the drug discount card benefit winds down toward its May 15 expiration date, it’s important to educate your patients about Part D and the benefits of enrolling in a plan before the initial enrollment deadline of May 15.  Patients who are using the Community Care Rx Drug Discount Card (DDC) will not automatically be enrolled in a CCRx Part D plan. They need to enroll in the same manner as all other CCRx beneficiaries: paper enrollment application, online, phone, or with an enroller from Community Care Outreach Services (CCOS).

DDC patients should use any remaining Transition Assistance funds immediately. You can help your patients maintain their access to needed medications by educating them about the CCRx Part D plans which provide more coverage than the DDC and encouraging them to apply for the low income subsidy through the Social Security Administration. The earlier they apply, the sooner they can take advantage of the subsidy and cost savings.  Don’t let your patients end up in the last minute crunch of beneficiaries trying to enroll before the May 15 deadline. We expect enrollments the last two weeks of May to be as hectic as they were the last two weeks of December. By enrolling in a CCRx Part D plan now, your DDC patients should experience a smooth transition from their DDC to Part D benefit.
 

Following is a description of each category and their Part D benefit level.

Medicaid Only: Eligible for Medicaid benefits, categorically, or through optional coverage groups such as medically needy or special income levels for institutionalized or home and community-based waivers, but do not meet the income or resource criteria for QMB or SLMB. Federal financial participation (FFP) is Federal medical assistance percentage (FMAP).

• Full-benefit Medicaid patient that previously had prescription coverage under the Medicaid benefit
• Claim may adjudicate at three different levels:
  • $0 cost-sharing for institutionalized full-benefit dua
  • $1/$3 cost-sharing for full-benefit dual with income below 100 percent of the Federal Poverty Level (FPL)
  • $2/$5 cost-sharing for full-benefit dual with income above 100 percent of the FPL

Qualified Medicare Beneficiary (QMB)*: Entitled to Medicare Part A, income of 100 percent Federal Poverty Level (FPL) or less, and resources that do not exceed twice the SSI limit ($4,000 for an individual, and $6,000 for a couple).  FFP is FMAP.

• May have a Medicaid card
• Medicaid pays for patient’s Medicare Part B premium and cost-sharing
• Pays $2/$5 cost-sharing for Part D benefit

Specified Low-income Medicare Beneficiary (SLMB)*: Entitled to Medicare Part A, income above 100% FPL but less than 120% FPL, and resources that do not exceed twice the SSI limit ($4,000 for an individual, and $6,000 for a couple).  FFP is FMAP.

• May have a Medicaid card
• Medicaid pays for patient’s Medicare Part B premium but not Medicare Part A and B cost-sharing
• Pays $2/$5 cost-sharing for Part D benefit

*QMB Plus and SLMB Plus categories were created when Congress changed eligibility criteria for QMBs and SLMBs to eliminate the requirement that QMBs and SLMBs could not otherwise qualify for Medicaid.