Federal and State Legislative Update

San Diego—The federal budget sequester struggle, the continuing movement toward the implementation of the Patient Protection and Affordable Care Act (ACA), and issues facing Medicare Part D are among the most significant legislative and regulatory proposals of interest to managed care pharmacy.

Daniel Tomaszewski, PharmD, PhD candidate, The College of Pharmacy at the University of Minnesota, Duluth, focused on the legislative and regulatory framework at the federal and state level in a Contemporary Issues session at the AMCP meeting. The session was titled Federal, State, Legislative, and Regulatory Update.

While there are no layoffs expected at the FDA, the sequester does affect the regulatory agency because its budget received $210 million in cuts, approximately 8.75% of its remaining budget for fiscal year 2013. AMCP, in a policy statement, continued to advocate for adequate FDA funding.

All provisions of the ACA, passed in 2010 and upheld in 2012 by the Supreme Court, will be implemented in 2014. Though the ACA was a landmark piece of federal legislation, the states are largely charged with implementation unless they default to the federal administration of insurance exchanges.

States with significant populations that have deferred to the federal exchanges include New Jersey, Pennsylvania, Texas, and Florida; states that will run their own exchanges include California, New York, and Massachusetts. The US Department of Health & Human Services will take plans from states until July 2013; enrollment of patients into the exchanges, whether federal or state, will begin October 1, 2013.

Another federal issue affecting managed care pharmacy is possible changes or modifications in policies outlined in the Medicare Part D Call Letter, released annually by the Centers for Medicare & Medicaid Services (CMS).

Among the key issues addressed in the 2014 Call Letter was a medication therapy management (MTM) data analysis that CMS performed using chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF) data from 2010. The analysis found that patients who received MTM had lower rates of hospitalization than those who did not receive MTM; that patients who received a comprehensive medication review (CMR) had even better outcomes than those who did not; and that MTM is more effective when focused on the overall health of a patient rather than when it is focused on the disease.

CMS is expanding its qualitative and quantitative MTM analysis and is suggesting that implementing a $0 copayment and MTM for hypertension treatment would improve effectiveness. CMS is also seeking comment on whether Part D plans should offer awards or incentives.

Another issue in the Call Letter was the instance of inappropriate cost shifting of benefits from Part B to Part D. CMS has received complaints about improper use of prior authorization (PA); a major CMS goal is to make sure that PA forms be used to ensure appropriate clinical utilization of medications and not to determine delivery systems or mechanisms. As for opioid utilization, a controversial issue, CMS proposes to expand utilization controls to antipsychotics, amphetamines, benzodiazepines, and non-benzodiazepine sleep aids. Regulations concerning hydrocodone rescheduling (as CII) are being discussed by the FDA as well as by a bill in the House and one in the Senate.

Currently, there are 3 bills pending in Congress that would establish a system of negotiation for drug prices between pharmaceutical manufacturers and the federal government. The bills are sponsored by Senators Al Franken and Amy Klobuchar (both MN-Dem) and in the House by Representative Peter Welch (VT-Dem). Another bill pending in Congress would establish a nationwide public option for Medicare Part D.

There is legislation pending on the federal and state level concerning biosimilars; on the federal level, regulations are pending on approval and interchangeability. On the state level, bills have been introduced in 17 states; 3 have passed regulations and legislature has failed in 5 states.

States and the federal government are currently drawing up regulations to increase oversight of compounding pharmacies, as the FDA is looking to regulate compounders acting as manufacturers and states are trying to expand authority for pharmacy regulation and inspection.

The AMCP has taken positions on many of the legislative and regulatory initiatives mentioned during this session and is actively involved in advocating for its positions and members; for information, visit www.amcp.org.