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§ The Senate confirmed the nomination of Michael O. Leavitt as Secretary of Health and Human Services.

§ Confirmation hearings offered a sneak peak at the congressional agenda with several issues impacting health-system pharmacy at the forefront:

• Medicare Modernization Act
in January 2006
Republicans pledged to reject major amendments to the benefit this year although many lawmakers suggested that technical corrections could be necessary to ensure smooth implementation.

• Drug Importation
With continuing pressure from the public for legalization of prescription drug importation, Leavitt noted that he would consider importation if the practice is proven safe and cost effective.

• Patient Safety
Leavitt and several senators identified patient safety as a priority, particularly related to medical error reporting. A renewed commitment was expressed to improve health information technology.

• FDA Reform/Drug Safety
Due to increased scrutiny for the FDA to ensure safety of our drug supply, Leavitt was asked to expedite naming a new FDA head.

• Medicaid
Medicaid could be a prime target for cost containment strategies due to President Bush’s promise to halve the budget deficit in five years.

§ The Combat Meth Act was introduced to restrict the sale of nonprescription cold medicines that contain pseudoephedrine.

• Pharmacy employees (licensed pharmacist or pharmacy technician) would be required to check photo I.D.s and keep a log of everyone who buys pseudoephedrine-based products. No person would be permitted to purchase more than 9 grams of the substance within a 30-day period unless dispensed with a valid prescription. Some exceptions do apply.

§ The Centers for Medicare & Medicaid Services (CMS) issued its final regulations

(Jan. 28 ’05) to implement the new Medicare Prescription Drug Benefit that will begin on January 1, ’06. Here are ASHP issues of key importance to pharmacists:

• Definition of “Dispensing Fee”
• P&T Committee – CMS’ proposed rule sought comment on whether a Prescription Drug Plan (PDP’s) P&T Committee’s decisions should be binding on the plan, and whether more than one physician and pharmacist on the P&T Committee should be independent and free from conflicts of interest.

• Formulary Development
CMS asked for comment on what criteria and standards the agency should use to determine that a plan’s formulary system that is not based on the USP model classification system does not discriminate against certain classes of eligible Medicare beneficiaries.
• Medication Therapy
Management Programs (MTMPs)
CMS admitted that the agency does not “have extensive experience requiring or reimbursing for MTMPs, sought comments on a multitude of issues regarding best practices, components, qualifications and quality assurance requirements.”

§ ASHP responded to the CMS February 4 proposed rule that would adopt standards for an electronic prescription drug program under Title I of the Medicare Prescription Drug, Improvement and Modernization Act of 2003. (MMA).

§ ASHP responded to the CMS March 4 proposed rule that would implement a competitive acquisition program for certain Medicare Part B drugs not paid on a cost or prospective payment system basis, as required by the MMA.

§ ASHP provided comments on the FDA March 14, 2003 Federal Register notice requesting comments on the agency’s proposed rule that would require manufacturers to place bar codes on drug products and blood.

§ ASHP adopted a policy on counterfeit drugs with a purpose to encourage the FDA to develop and implement regulations to restrict or prohibit licensed drug distributors from purchasing legend drugs from unlicensed entities and to document in the distribution chain the original source of drugs and chain of custody from the manufacturer to the pharmacy.

§ CMS May 18 proposed rule eliminates mention of funding for allied health professional education, particularly for pharmacy residency program. CMS stated that the agency was ending reasonable-cost, pass-through funding for second-year specialized pharmacy residency programs because CMS determined that second-year residencies would not qualify for reasonable cost pass-through payment because it is not currently the ‘industry norm’ for hospitals to require completion of these programs before begging work in these specialties.

• NJSHP sent a letter on June 13 to the CMS to protest the agency’s decision not to restore funding for specialty residency programs.

• NJSHP also contacted the offices of Senators Jon Corzine and Frank Lautenberg to enlist their support for funding for pharmacist education.

• ASHP conducted a survey that showed 82% of hospitals that employ clinical pharmacy specialists require specialized pharmacy residency training for these practitioners.