Breaking News

February 7, 2005

Under the final rule issued by CMS for the Medicare Rx drug benefit, the pharmacy access standard has been changed to apply on a state-by-state, rather than a regionwide, basis. In addition, the final rule will now allow certain nonretail pharmacies, such as federally qualified health centers, to be in Rx plan networks; will follow any-willing-provider provisions to allow any pharmacy of any type to join a network under standard contract terms; and will make it easier for beneficiaries to get drugs from non-network pharmacies.

CMS issues Medicare Rx final rule Under the final rule issued by CMS for the Medicare Rx drug benefit, the pharmacy access standard has been changed to apply on a state-by-state, rather than a regionwide, basis. In addition, the final rule will now allow certain nonretail pharmacies, such as federally qualified health centers, to be in Rx plan networks; will follow any-willing-provider provisions to allow any pharmacy of any type to join a network under standard contract terms; and will make it easier for beneficiaries to get drugs from non-network pharmacies. Noting that any qualified providers, not just R.Ph.s, can be used to deliver medication therapy management programs mandated by the law, the final rule gives drug plans flexibility to develop such programs. NCPA said the regulations for long-term care coverage would open competition to smaller pharmacies.

Medicare proposes e-prescribing rules HHS has proposed regulations to support electronic prescriptions for the Medicare Rx benefit. The proposed rules set standards for transactions between prescribers and R.Ph.s on new Rxs, refill requests, Rx cancellation requests, and related messaging, as well as eligibility and benefit inquiries between prescribers and Rx plans, and formulary and benefit coverage information. The proposed compliance date is next Jan. 1. HHS will accept comments on the proposed rules through April 5. For more information, go to http://www.cms.hhs.gov/.

Wegman funds N.Y. pharmacy school Robert B. Wegman, chairman of Wegmans Food Markets, has donated $5 million to fund the creation of the Wegman School of Pharmacy at St. John Fisher College in Pittsford, N.Y. Construction is expected to begin next fall; the school is set to open in 2006 with an initial class of 50 students. The new facility will become the fifth pharmacy school in New York State.

MTM programs automated Pharmacy OneSource and Applied Informatics unveiled MTM OneSource to automate the delivery of medication therapy management (MTM) consultations in the Medicare drug benefit. The integrated solution includes basic DUR, patient-specific checks on drug dosing and drug-disease conflicts, compliance tracking, medication profile risk prediction, patient education materials, R.Ph. annotation, and report generation and archiving. The Web site is at http://www.mtmonesource.com/.

Leavitt confirmed to head HHS The Senate confirmed former Utah governor Michael Leavitt as secretary of HHS, replacing Tommy Thompson. Leavitt moved over from his position as head of EPA. Sen. Byron Dorgan (D, N.D.) dropped threats to hold up Leavitt's appointment after Senate Republican leaders reportedly agreed to hold hearings soon on bipartisan legislation to allow Rx importation from Canada and other industrialized countries.

Medicine Shoppe kicks off new ad campaign Medicine Shoppe International, a subsidiary of Cardinal Health, kicked off a national advertising campaign that touts the unique customer experience Medicine Shoppe pharmacists provide. Dubbed "Caring Beyond Prescriptions," the campaign includes TV and radio ads that highlight customers' experiences.

JCAHO urges patients to 'speak up' to prevent drug errors JCAHO has launched a national campaign urging Americans to speak up as a way to avoid medication errors. The organization forwarded brochures and posters to Fortune 1000 companies with the theme "Things You Can Do to Prevent Medication Mistakes." The PR blitz will focus on med errors that occur in hospitals as well as those associated with other settings. In addition to sharing the brochure, JCAHO is asking employers to encourage their employees to complete a wallet card entitled "My Medication List," which people can share with their R.Ph.s, doctors, and other caregivers. The brochure, card, and poster can be downloaded at http://www.JCAHO.org/.

Medco outsources R.Ph. help desk Medco Health Solutions has reportedly outsourced its pharmacy help desk to India, according to NCPA. After encountering difficulties getting answers to their questions, some NCPA members confirmed with the help desk reps that they were based in India. One member speculated that such outsourcing raises the specter of PBMs going offshore for cheaper labor to fill Rxs if drug importation is legalized in the U.S. Asked for a response, Medco did not call back.

Public Citizen asks FDA for Celebrex, Bextra withdrawal The consumer advocacy group Public Citizen has petitioned the FDA to withdraw the COX-2 inhibitors celecoxib (Celebrex, Pfizer) and valdecoxib (Bextra, Pfizer) from the market. Public Citizen cited cardiovascular risks associated with the use of these drugs as the reason for its request. The petition also requests that the FDA freeze applications for etoricoxib (Arcoxia, Merck) and lumiracoxib (Prexige, Novartis) for the same reason. Pfizer said it "remains confident in its COX-2 medicines as important treatment options that provide necessary pain relief for patients around the world." A Merck spokeswoman and a Novartis spokesman both said they believe it is inappropriate to comment on the petition before the FDA meeting on Feb. 16-28 to discuss the risks and benefits of COX-2 inhibitors.

Antiretroviral cocktail recommended after HIV exposure CDC has released new recommendations for preventing HIV infection due to nonoccupational exposure to HIV. CDC recommends that within 72 hours after exposure to potentially infectious bodily fluids of a person known to be infected with HIV, a 28-day course of highly active antiretroviral therapy (HAART) should be started. The recommendations were published in the Jan. 21 Morbidity and Mortality Weekly Report and are available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5402a1.htm.

Final wording for antidepressant warnings approved Officials from the FDA said that they have approved the final wording for black box warnings to be added to the labeling of certain widely prescribed antidepressants, including paroxetine (Paxil, Paxil CR). The warnings advise consumers that the drugs can cause suicidal thoughts and actions in those under age 18. The labeling must be placed on manufacturers' Web sites within two weeks and on all products within 30 days, according to an agency letter to drugmakers. Wyeth recently added the warning to its antidepressants paroxetine and tranylcypromine (Parnate).

Merck acts to issue refunds for undispensed Vioxx Merck has announced the following new developments in its rofecoxib (Vioxx) refund program: By mid-February, all pending pharmacy returns will be processed by NNC, which is coordinating the returns process, and then submitted to Merck. Merck will review and authorize the reimbursement of return requests within approximately 10 business days after receiving the data from NNC. NNC will then issue reimbursement checks directly to pharmacies. Pharmacies awaiting a refund should receive payment in the first weeks of March. Merck advised that those still awaiting a reimbursement check on March 31 can contact NNC at 1-(800) 805-9542.

First quadrivalent meningitis vaccine gets FDA nod The FDA has approved meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (Menactra, Sanofi Pasteur) for the prevention of meningococcal disease in adolescents and adults age 11 to 55. According to Sanofi Pasteur, Menactra is the first quadrivalent conjugate vaccine approved in the U.S. for the prevention of meningococcal disease caused by Neisseria meningitidis.

CVS exits drug network CVS has voluntarily left the pharmacy networks provided by the Toyota Motor Co. and the state of Ohio because the PBMs in those programs require patients with chronic illnesses to use mail-order companies to refill their Rxs. "We feel strongly that plans like this one are not in our patients' best interest, as they lose the option to access personal interaction and counseling from a community pharmacist," said a CVS spokeswoman, adding that CVS isn't opposed to filling Rxs through the mail, since its own PharmaCare subsidiary does that. "What we oppose are prescription plans that severely limit patients' ability to choose their preferred channel of delivery," she said.