AMCP Provides Federal and State Update

San Antonio—A range of issues at the federal and state level are affecting managed care pharmacy. Sean Karbowicz, PharmD, director, clinical evaluation and policy at RegenceRx, provided an update on some of the most significant legislative and regulatory proposals of interest to managed care pharmacy during a webinar titled Federal & State Legislative & Regulatory Update, which was available to AMCP meeting attendees.

Dr. Karbowicz started the presentation with a federal fiscal update. The sequester—the across the board, automatic federal budget cuts that took effect March 1 was mandated by the Budget Control Act of 2011. Except for Social Security and Medicaid, all other government programs received an approximately 5% budget cut. Medicare received only a 2% cut in its budget, which was solely born by the providers and not the beneficiaries.

“Compounding the problem—the amount of cuts was based on a full year’s operating budget. However, since there were only 7 months left in the current fiscal year when it was imposed, agencies had to find a full year of cuts in a shorter amount of time," explained Dr. Karbowicz.

Another federal issue important to managed care pharmacy is possible changes or modifications outlined in the Centers for Medicare & Medicaid Services (CMS) 2014 Call Letter, which included Medicare Part D parameters. One key issued addressed in the call letter was medication therapy management (MTM) programs, which have been part of the Medicare Part D program since its inception in 2006. In response to the MTM proposals, AMCP submitted the following recommendations to CMS:

•   Standards of practice should focus on plan-based MTM

•   Consider a variety of interests before setting standards of practice

•   Develop a payment methodology for MTM

•   Include MTM in medical loss ratio (MLR) calculations

CMS final rule in May 2013 allows for MTM in MLR if it meets certain requirements for quality improvement, according to Dr. Karbowicz. He also highlighted MTM data analysis performed by Acumen on behalf of CMS using congestive heart failure and chronic obstructive pulmonary disease data from 2010. The findings showed that MTM generally improved health outcomes, adherence, and lowered rate of emergency visits and hospitalizations. Beneficiaries who received comprehensive medication reviews had better outcomes and pharmacist–physician communication improved outcomes.

While AMCP is generally supportive of the study findings, the association recognizes additional research in MTM outcomes and costs are necessary. “AMCP encourages the government agencies to use managed care organizations to conduct this research,” said Dr. Karbowicz.

He provided a brief update on Medicare Part D legislation. Currently, 3 bills have been introduced in 2013 and pending in Congress that would establish a system of negotiation for drug prices between pharmaceutical manufacturers and the federal government. He also noted pending legislation that would expand MTM programs to include beneficiaries with 1 chronic condition. “AMCP opposes efforts to arbitrarily expand MTM benefit based solely on disease states,” he said.

Controlled substances also continue to be a “hot button issue,” according to Dr. Karbowicz. AMCP’s legislative committee is currently developing a position statement on the appropriate management of the opioid therapeutic class. He noted one issue surrounding controlled substances is the substitution of generic opioids that do not have a tamper-resistant formulation (TRF). Draft guidance for the industry was released in 2013 and 7 states have considered legislation to restrict substitution of non-TRF generics. On the federal level, the Stop Tampering of Prescription Pills Act of 2013 would require the FDA to define TRF and would prohibit approval of non-TRF generics.

For more information on the positions and actions AMCP has taken on the issues discussed in the presentation, visit www.amcp.org.