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CMS is considering changing the date when new Part D enrollments received late in the month become effective. Beneficiaries who sign up late in the month may not have an Rx card or be entered in the eligibility database, causing delays and confusion at the pharmacy counter.

CMS has updated the Part D performance standards for 2007 to require drug plans to operate a toll-free pharmacy technical help call center that is open for the entire period during which network pharmacies in their service areas are open. Thus, if a network includes pharmacies open 24 hours, the plan's technical help desk must also be open round-the-clock.

Long-term care pharmacy providers and consultants rated Pfizer as the drug company with the promotional activities that best met their needs with regard to Medicare Part D prior to implementation of the drug benefit. Johnson & Johnson, Forest, Novartis, and Amgen rounded out the top five in Verispan's Fall 2005 nursing home promotional audit.

Legislators in Kansas and Nebraska have introduced bills to tighten regulation of drug wholesalers, a move supported by pharmacy associations and state pharmacy boards. The Kansas legislation would require licensure of the nearly 700 wholesalers doing business in the state and institute other drug supply safeguards.

A citizen's petition has been filed with the FDA calling for a phased withdrawal of propoxyphene-containing drugs due to their toxic side effects. The group responsible for the move, Public Citizen, said that the risks associated with the painkiller—including the conversion of the drug to a toxic metabolite that leads to cardiac depression—far outweigh the benefit.

An Instant Poll on Drug Topics' Web site, posted in February, found that most respondents think that Tysabri (natalizumab, Biogen Idec) should be brought back to the market. Out of 145 people who voted, 68% said the multiple sclerosis agent should be brought back but with new warnings added, 16% said it should be restored with no new restrictions added, only 10% said it should not be returned to market, and 6% said they didn't know whether FDA should let it come back.

Ever since the sole U.S. manufacturer of varicella zoster immune globulin (VZIG) discontinued its production in October 2004, supply has dwindled to the point of depletion. This February, however, an investigational VZIG product, called VariZIG, has become available under an investigational New Drug Application (IND) for patients who have been exposed to varicella and are at increased risk for severe disease and complications.

Sanofi-Aventis has announced that Apidra (insulin glulisine [rDNA origin] injection) is now available for the control of hyperglycemia in adult patients with Type 1 and Type 2 diabetes. Apidra is a rapid-acting insulin with an onset and duration of action that are faster and shorter than those of regular human insulin.

Specialty pharmaceutical company Santarus has received FDA approval for immediate-release proton pump inhibitor Zegerid. The new product contains omeprazole and sodium bicarbonate in 40 mg/1100 mg and 20 mg/1100 mg combinations.

Coverage for psychotropic drugs under Medicare Part D is under fire. The goal of covering all or substantially all products and providing appropriate care for all patients is not being met.

As if the cash flow problems many pharmacists are experiencing lately due to Medicare Part D aren't bad enough, President Bush just delivered another sucker punch to the nation's drug professionals. He signed the budget reconciliation bill, which cuts Medicaid reimbursement to pharmacies for generic drugs by a whopping $6.3 billion over the next five years.

Nearly all persons enrolled in Medicare Part D prescription drug plans (PDPs), except those with the most generous subsidies or those in high-end plans, are subject to co-pays and deductibles. CMS has provided for a central reporting mechanism for recording these out-of-pocket expenditures. The amount a beneficiary must spend on Part D drugs to reach the catastrophic coverage provision is being called "true out-of-pocket," or TrOOP, expenditure. In 2006, persons covered by a PDP are eligible for catastrophic coverage after they have paid $3,600 in TrOOP cost. The threshold can change annually as provided by the Medicare Modernization Act (MMA).

Lou Spadafora, co-owner of Midland Pharmacy on Staten Island, N.Y., bounced a check for $51,000 last month. The pharmacy's bank account was $2,000 short of covering the check. It wasn't the first check he bounced, because he serves a lot of dual eligibles in group homes who were switched from Medicaid to Medicare Part D.

The Food & Drug Administration recently approved sunitinib (Sutent, Pfizer) for the treatment of gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib (Gleevec, Novartis). Sunitinib was also granted accelerated approval for the treatment of metastatic renal cell carcinoma (MRCC). This is the first time that the agency has approved an oncology drug for the treatment of two indications simultaneously.

In an attempt to eradicate hepatitis B virus (HBV) from the United States, the Centers for Disease Control & Prevention Advisory Committee on Immunization Practices (ACIP) issued updat-ed guidelines for vaccination against the disease.

The American Heart Association (AHA) estimates that approximately 6.6 million Americans are affected with chronic angina.

Pharmacies already reeling from the botched implementation of Medicare Part D took another body blow Feb. 1, when Congress narrowly approved federal Medicaid reimbursement cuts of $3.6 billion over the next five years. Just five days later, the Bush Administration's new budget proposed lopping an additional $1.3 billion from Medicaid reimbursement.

Pharmacies that want to pull out of Medicare Part D should check the fine print of their drug plan network contracts.

In remarks about his proposed 2007 budget and deficit reduction, President Bush said, "People talked about how the decision to reform Medicaid was immoral. Well, it's not immoral to make sure that prescription drug pharmacists don't overcharge the system.... It turns out that there was inflated markups for people who had government help to buy drugs. That doesn't make sense, so we reformed that. The people are still going to get their drugs, but the taxpayers aren't going to pay inflated prices." Bush's accusation about pharmacy overcharging came the same day HHS secretary Michael Leavitt repeated his praise of R.Ph.s for their "heroic" efforts to help patients get their Medicare Part D drugs.

The HealthWell Foundation, a nonprofit organization that assists indigent patients in meeting their cost-sharing obligations for Rx medications, has launched four new programs to help patients afford the medical treatments they need. The new programs will assist patients with colorectal cancer, moderate to severe asthma, non-small cell lung cancer, and non-Hodgkin's lymphoma.

NCPA has urged CMS to not allow drug plans and drugstore chains to co-brand Part D identification cards. Independent pharmacists contend that the co-branded Rx cards confuse beneficiaries into mistakenly thinking they can get their medications only at the drugstores shown on their ID cards.

Charfoos & Christensen has filed a lawsuit against Walgreens on behalf of Michael Wells in U.S. District Court, Eastern District of Michigan. Attorney Douglas Peters of Charfoos & Chistensen told Drug Topics that Wells' surgeon prescribed the antibiotic Duricef (cefadroxil/cefadroxil hemihydrate, Warner Chilcott) to prevent the development of postsurgical wound infection.

First DataBank has introduced the OrderView Med Knowledge Base CPOE-ready drug database designed to be physician-friendly by reducing mouse clicks and drug pick lists, according to the San Diego technology firm. One component of the system is Orderable Meds, which focus only on data necessary for ordering, not for dispensing, administration, research, or billing.

The American College of Apothecaries (ACA) has created the American College of Hospice Pharmacists for R.Ph.s interested in strengthening their knowledge and skills in hospice care and pain management. Programs being developed for the specialty college include separate newsletters for pharmacists, prescribers, and patients/caregivers, as well as a 20-hour didactic certificate program to be offered during ACA's annual meeting and a lab-based 16-hour certificate program to be offered at ACA's Research & Education Center.

Physicians will be able to securely access patient medication histories through pharmacies that belong to the SureScripts electronic prescribing network. Physicians will be able to see a patient's medication records and pharmacy data, such as allergies and when drugs were dispensed, across all prescribers.

CMS has ruled that prescription niacin products, such as Niaspan and Niacor, are prescription vitamins and are, therefore, excluded from Part D coverage. After May 31, the two products cannot be included in Part D formularies.

A group of pharmacists has launched USGenerics, an on-line pharmacy offering patients FDA-approved generics for 30-day and 90-day scripts. To keep prices low, the Wisconsin-based firm does not accept any insurance plans.