AMCP Addresses Stance on Federal and State Legislative and Regulatory Moves

Boston—Legislation on medication therapy management (MTM) expansion and Medicare drug price negotiations are being discussed on the federal level, while states are considering legislation in the areas of biosimilars, controlled substances, and benefit design. These are highlights from a session presented at the AMCP meeting that gave an update on both federal and state legislative efforts. The session, led by Mark Hopman, RPh, MBA, director, national retail, Dexcom, also addressed the 2015 Medicare Part D call letter, the recent Medicare Part D final rule, and ways to participate in managed care advocacy efforts.

Mr. Hopman opened the session by providing an update on federal funding for the FDA. According to the presentation, for the fiscal year 2014, the FDA received $2.5 billion. This figure not only restored presequester funding, but it also increased the FDA funds beyond appropriations in fiscal year 2012. Dr. Hopman said AMCP would like to see an increase in funding for fiscal year 2015 as well.

Also this year, a final Medicare Part D rule was issued that includes provisions to reduce fraud as well as require regular updates and reporting of maximum allowable cost pricing as part of network contracts. Under the final rule, plans that contract with the Centers for Medicare & Medicaid Services (CMS) will be required to disclose all individual drug prices and provide updates to pharmacies before claims are reimbursed. In addition, plans will have to notify pharmacies when medications are added or removed from the maximum allowable cost list. According to the presentation, AMCP opposes the maximum allowable cost reporting requirements because the organization feels that it could hinder competition or prevent aggressive negotiations from taking place between pharmacies and plans.

While AMCP may oppose the maximum allowable cost reporting requirements, Mr. Hopman said there were initially other areas of concern in the proposed rule that was first announced in January. However, after advocacy efforts from AMCP and others in the industry, the final rule that was issued revised most of the more controversial provisions, according to Mr. Hopman.

In addition to the Medicare Part D final rule, there was also a Medicare Part D call letter, which includes rates and nonbinding policy regulations that was finalized earlier this year, and MTM was 1 area discussed in the final letter. According to the call letter, the CMS will develop new audits for MTM that may impact Medicare Star ratings.

The letter encouraged plans to:
• Cover more populations outside Medicare targets with MTM
• Add management of opioids
• Adopt electronic MTM standards

Each year, Medicare Part D sponsors must submit a MTM program description for the CMS to review and approve. To aid sponsors, the CMS issued guidance for 2015 Medicare Part D MTM programs. This year, the guidance maintained minimum requirements for targeted MTM beneficiaries and encouraged plan sponsors to expand the eligible population with a focus on opioid management as well as blood pressure.During the presentation, Mr. Hopman also discussed current legislation and the position AMCP has taken on the issues. For example, several bills have been introduced that would legislate Medicare drug price negotiations, if approved. AMCP opposes federal negotiation of drug prices and is advocating against this legislation. Another area of concern on the federal level is the expansion of MTM programs. According to the presentation, there is proposed legislation that would expand MTM programs to include beneficiaries with 1 chronic condition. Mr. Hopman said that while AMCP supports MTM, the organization does not believe it should be expanded based solely on disease states without some additional research or evidence to support the expansion.

One area AMCP would like to see legislation passed is fraud. According to Mr. Hopman, AMCP continues to advocate for the introduction of their antifraud bill, which would amend current “prompt pay” requirements and give sponsors the ability to suspend payment if fraud is suspected.

Discussion about the regulation of drug products, such as biosimilars, specialty tiers, or controlled substances, is also occurring at the federal level, and AMCP is currently providing advocacy efforts in these areas. For biosimilars, AMCP is working with other stakeholders to convince key federal agencies and Congress of the importance of common naming of biosimilars.

On the state level, AMCP is working to oppose legislative efforts to regulate substitution differently from other drug categories and also to oppose requiring additional prescriber or patient notification of a substitution or labeling requirements for pharmacists.

Mr. Hopman said biosimilar bills are pending in 4 states across the United States and have been adopted into law in 3 states. States are also looking into legislation regarding controlled substances and benefit design and operations.
According to Mr. Hopman, 17 states have considered legislation to regulate the pharmacy audit process, with 5 states ultimately enacting laws. Some states are also considering mandates that would require a uniform prior authorization process, while others have considered legislation to the mail-order process.—Jill Sederstrom