NCPA Congressional Pharmacy Summit
Less than 3 Weeks Away

The NCPA Congressional Pharmacy Summit is less than 3 weeks away. There is still time to register to take advantage of several CE opportunities as we provide you with a legislative briefing and the latest Medicare and Medicaid updates. Then you will have an opportunity advocate for your pharmacy, your patients and your profession in meetings with legislators to encourage them to support common sense legislative reforms. If you need additional inspiration, view this invitation from pharmacy champion, Congressman Doug Collins (R-Ga.) expressing the importance of pharmacist attendance. See the agenda for more information.

NCPA Responds to Senate Drug Pricing Transparency Request

On Friday, NCPA responded to a request from six Senators, led by Sen. Bill Cassidy (R-La.) and including Sen. Michael Bennet (D-Colo.), Sen. Charles Grassley (R-Iowa), Sen. Tom Carper (D-Del.),Sen. Todd Young (R-Ind.) and Sen. Claire McCaskill (D-Mo.), for comments regarding the ongoing effort to improve health care price and information transparency. In the letter, NCPA highlighted the critical role community pharmacies play in ensuring patients have immediate access to medications and offer face-to-face counseling, as well as other services to help boost patient adherence to medications. NCPA reiterated its commitment to working collaboratively with members of Congress, the Administration, and other stakeholders in adopting viable solutions to increase drug pricing transparency, but also noted these issues cannot be adequately addressed without addressing the role PBMs play in increasing prescription drug costs.

President Trump Talks Opioids, Hints
at Major Drug Pricing Announcement

During a speech this week to announce new initiatives to address the opioid crisis, President Trump announced the White House will have a major announcement and news conference on drug pricing “in about a month.” He indicated the U.S. pays much more for prescription drugs because of the “drug lobbies” and “other reasons,” including the distribution system, which he indicated is a way to figure out how to “get more money.” He asserted that U.S. drug costs are many times higher than prices in other countries for the exact same pill or other medication, in the same package and made in the same plant. He indicated the Administration plans to change that dynamic.

Secretary Azar echoed the President’s comments, indicating the Administration will roll out a slate of proposals in about a month to decrease drug prices, including a focus on shifting the discounts “middlemen” receive and instead providing those discounts to individuals.

House Energy and Commerce Committee
Keeps Focus on Opioids

This week, the House Energy & Commerce Committee held two hearings related to the opioid crisis. On March 20, 2018, the Subcommittee on Oversight and Investigations held a hearing entitled, “The Drug Enforcement Administration’s Role in Combating the Opioid Epidemic,” focusing on the Drug Enforcement Administration’s (DEA) enforcement approach and actions to detect and investigate suspicious opioid orders. Subcommittee Chairman Gregg Harper (R-MS), Committee Chairman Greg Walden (R-OR), Subcommittee Ranking Member Diana DeGette (D-CO), Committee Ranking Member Frank Pallone (D-NJ), and multiple Members on both sides of the aisle criticized the DEA for its failure to take timely, effective action to address the opioid epidemic. Members repeatedly cited examples of excessive opioid prescriptions and orders, particularly in small, rural communities in West Virginia, that were allowed to continue for years, even in cases where distributors reported suspicious orders to the DEA. On March 21-22, 2018, the Health Subcommittee held a two day hearing to consider 25 opioid bills focused on public health and prevention. There was broad interest among Members on both sides of the aisle in the hearing and the ideas presented, including developing innovative technologies and new approaches to dispose of unused opioids and reduce diversion; addressing opioid-related infectious diseases; considering abuse potential in FDA approval processes; and improving Prescription Drug Monitoring Programs (PDMPs).

Congressmen Buddy Carter and Peter Welch
Seek to Address Gag Clauses

This week, NCPA endorsed new legislation introduced in the House of Representatives by Representatives Buddy Carter (R-Ga.) and Peter Welch (D-Vt.) which addresses gag clauses. H.R. 5343, the Prescription Transparency Act of 2018, would grant pharmacists the ability to make patients aware if there is a lower cost option for their prescription drugs. This legislation, which is also cosponsored by Morgan Griffith (R-Va.), Austin Scott (R-Ga.), Doug Collins (R-Ga.) and Cathy McMorris Rodgers (R-Wash.), is similar to two bipartisan Senate bills introduced last week, S. 2553, the Know the Lowest Price Act of 2018, and S. 2554, the Patient Right to Know Drug Prices Act.

Congress and President Trump Avert Shutdown
and Clarify Congressional Intent on Compounding

Late Thursday night, the Senate cleared the FY19 Omnibus Appropriations package, following after the House approved the packaged Thursday morning. The bill provides $1.3 trillion in discretionary funding for all 12 annual Appropriations bills. Congress committed roughly $4 billion to fight the opioid crisis. Included in that $4 billion is $500 million for research on opioid addiction and new non-addictive pain therapies at NIH; $130 million to address opioid addiction in rural areas; and $94 million that would help FDA expand its efforts to crack down on shipments of synthetic opioids at international mail facilities. In addition to the funding measures, the Omnibus Appropriations package also includes Report Language on compounding that addresses concerns with FDA implementation of the DQSA in a manner that is contrary to Congressional intent. This does not change current law, but it does give strong directives to FDA to change the regulatory guidance documents and inspection processes that FDA has implemented.

President Trump averted a potential government shutdown and signed the bill early Friday afternoon after tweeting in the a.m. that he was considering vetoing it.

NCPA Government Affairs Team
Joins Pharmacy Ally in Hill Meetings

On March 20-21, 2018, NCPA’s lobbyists, Karry La Violette and Adam Harbison, joined Bill Eley, Director of Legislative Affairs for American Pharmacy Cooperative, Inc. (APCI) to conduct meetings with House & Senate offices from Alabama and Georgia. In partnership with APCI, these meetings discussed NCPA priorities with Members of Congress and their staff, including DIR fees.

NCPA Staff Represent on Behalf of Community Pharmacy

• NCPA’s SVP of Communications & State Government Affairs Scott Brunner, CAE represented NCPA at the NASPA Spring Meeting
• NCPA’s Associate Director of Public Affairs and Grassroots, Michael Rule, presented on behalf of NCPA at the Ohio Marshall County Pharmacists Association’s Spring Seminar
• NCPA’s Associate Director of State Government Affairs, Allie Jo Shipman, represented NCPA at the APhA annual meeting.

FDA Releases Draft Guidance on Bulk Substances

The U.S. Food and Drug Administration today issued for public comment a new draft guidance (“Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act”), which discusses the FDA’s interpretation of the statutory phrase “bulk drug substances for which there is a clinical need,” as well as the factors and processes that the FDA proposes to use when evaluating whether to include a bulk drug substance on the list of bulk drug substances that outsourcing facilities may use in compounding drugs.

In the states…

• Alabama HB 457, which provides further fair audit protections for pharmacies, passed both chambers and has been delivered to the governor.
• Kansas SB 351, which permits pharmacists to provide a covered person information related to the person’s cost share and lower-cost alternative drugs and which prohibits copayments that exceed total submitted charges by the network pharmacy, passed both chambers and will be sent to the governor.
• Kentucky SB 5, which would require the Department of Medicaid Services to directly administer all outpatient pharmacy benefits, was amended and passed in the House and sent back to the Senate for concurrence on the amendment.
• South Carolina H 5038, which prevents PBMs from prohibiting a pharmacist or pharmacy from providing information to insureds regarding cost share, prohibiting a pharmacist or pharmacy from providing ancillary delivery services, charging or collecting a copayment from an insured that exceeds the charges submitted by a network pharmacy, or retaliating against a pharmacist or pharmacy, passed the House and is headed to the Senate.
• Utah SB 184, which permits a pharmacist to dispense a self-administered hormonal contraceptive under a standing prescription drug order, was signed by the governor.
• West Virginia SB 46, which permits pharmacists to inform customers of lower-cost alternative drugs, was approved by the governor.