National News
 
Invite your Senator or Member of Congress to Your Pharmacy
The next Congressional recess begins today (June 28-July 8). This is a perfect time to invite your Senator or member or Congress - especially new members of Congress - to your store. With all the attention on drug prices and PBMs, this is a great opportunity to show them what really goes on in Community Pharmacy.
 
105 U.S. Reps., 28 U.S. Senators Urge Trump Administration to Fix Pharmacy DIR Fees
Nearly a quarter of the House of Representatives - 105 members - has sent a letter to President Donald Trump noting the "missed opportunity" to reduce seniors' out-of-pocket costs for prescription drugs. This missed opportunity occurred when pharmacy direct and indirect remuneration (DIR) fee reform was excluded from a recent Medicare rule.
 
The legislators, including one-third of the House Energy and Commerce Committee's majority members, urged the administration to finalize pharmacy DIR reform this year. Last week, 28 bipartisan members of the Senate, sent a similar letter. The letter from House members cited Centers for Medicare & Medicaid Services data indicating that "DIR fees on pharmacies participating in Part D grew by 45,000 percent between 2010 and 2017." The House members said, "This increase is unacceptable and unsustainable, and creates uncertainty not only for community and specialty pharmacies, but also for the patients who rely on Part D for prescription drugs. Until pharmacy DIR fee reform occurs, seniors will continue to pay higher cost-sharing for their prescription drugs."
 
The abuse of DIR fees is a result of a regulatory loophole. Payers claw back reimbursement paid to pharmacies for Medicare prescriptions, often more than half-a-year after the transaction. They allege that these fees are based on quality performance, yet these metrics lack transparency, vary widely, and often do not reflect areas under pharmacy's control.
From NCPA
 
Court Ruling Allows The Washington Post to Access DEA's Opioid Database 
A Drug Enforcement Administration (DEA) database that contains detailed information about how opioids are distributed in the US will be made available to The Washington Post, as per a June 20, 2019, ruling at the US Court of Appeals for the Sixth Circuit, according to a report from Bloomberg Law. The court ruled that DEA had failed to show "good cause" for keeping the database confidential. The decision is a reversal of an earlier decision in trial court. According to Cleveland.com, the ruling was sparked by requests by The Washington Post and the West Virginia-based newspaper chain HD Media for Automation of Reports and Consolidated Orders System data given to local governments in several states.
From NABP
 
Senate Committee Votes To Force Pharma To Justify Large Price Hikes
A key Senate committee last Wednesday voted to require drug companies to justify price hikes to the federal government if they exceed 10% in a year or 25% in a three-year span, advancing a proposal that also enjoys bipartisan support in the House. The measure, spearheaded by Sen. Tammy Baldwin (D-Wis.), was offered as an amendment to a broader health care bill being considered by the Senate's Health, Education, Labor, and Pensions Committee. Three other senators - two Republicans and one Democrat - co-sponsored the legislation, which the committee voted to include by a 16-7 margin.
By Facher, Published in Stat 6/26
 
Google And The University Of Chicago Are Sued Over Data Sharing
When the University of Chicago Medical Center announced a partnership to share patient data with Google in 2017, the alliance was promoted as a way to unlock information trapped in electronic health records and improve predictive analysis in medicine. On Wednesday, the University of Chicago, the medical center and Google were sued in a potential class-action lawsuit accusing the hospital of sharing hundreds of thousands of patients' records with the technology giant without stripping identifiable date stamps or doctor's notes. By Wakabayashi, Published in The New York Times, 6/26
 
Former FDA Commissioner Scott Gottlieb Joins Pfizer Board
Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb will join the board of directors of Pfizer, the company announced Thursday. Gottlieb stepped down in April after running the FDA for two years and is currently a resident at the American Enterprise Institute. One of his main priorities at the agency was to speed up the approval of new treatments, especially generic drugs and biosimilars - identical copies of a complex drug manufactured by a different company. 
By Weixel, Published in The Hill, 6/27
State News

ALABAMA
Pharmacies Can Now Sell CBD  
Governor Kay Ivey has signed Senate Bill 225 into law, allowing pharmacies to sell cannabidiol (CBD) products containing a maximum of 0.3% tetrahydrocannabinol (THC), according to a report from AL.com. The move was taken after the passing of a December 2018 bill in the United States Congress, which reclassified CBD derived from industrial hemp as an agricultural commodity, so long as it contained a THC concentration of 0.3% or less. Previous guidance from the Alabama State Board of Pharmacy noted that until the Alabama Department of Public Health removed hemp and hemp-derived products from the list of Schedule I controlled substances, pharmacists and pharmacies were required to abide by the strictest rule, thus were unable to sell CBD products.
From NABP
 
NEVADA
NACDS Praises New Law to Curb Opioid Abuse
Electronic prescribing bill (AB 310), will require prescriptions for controlled substances, including opioids, to be submitted electronically, which will help in the fight against opioid abuse. Nevada Gov. Steve Sisolak signed the bill into law June 7, and it will become effective Jan. 1, 2021.
 
In addition to e-prescribing, NACDS' recommendations relate to drug disposal, prescription drug monitoring plans, health plan design, pain management, and a seven-day supply limit on the first prescription of an opioid for a patient's acute - or temporary - pain.
By Sandra Levy, Published in Drug Store News, (edited)
 
OKLAHOMA
Attorney General Announces Settlement With Teva Pharmaceuticals in Opioid Case
Teva Pharmaceuticals has agreed to an $85 million settlement with the state of Oklahoma for its alleged role in fueling the state's opioid epidemic. The specific terms of the agreement have not yet been finalized, according to the Oklahoma Attorney General . A trial against the remaining defendant, Johnson & Johnson, began on May 28, 2019, as reported by NPR .
From NABP
 
WASHINGTON
CMS Approves Plan Amendment Proposal to Allow Supplemental Rebates
On June 12, 2019, the Centers for Medicare & Medicaid Services (CMS) approved the fourth Medicaid state plan amendment proposal to negotiate supplemental rebate agreements involving value-based purchasing arrangements with drug manufacturers that allows states to link payment for prescription drugs to the value delivered.
 
This approval is for the state of Washington and follows similar approvals for proposals from Oklahoma, Michigan, and Colorado.  Washington's proposal is specifically designed to allow the state to negotiate under a "subscription" model with manufacturers of prescription drugs that treat patients with the Hepatitis C Virus.
 
The approval of a state plan amendment to pursue supplemental rebate agreements involving value-based purchasing is the first that CMS has approved that is primarily focused on Hepatitis C drugs.
CMS-authorized supplemental rebates that pharmaceutical companies pay to states are exempt from the Medicaid "Best Price" rule.  This rule requires prescription drug manufacturers to offer the lowest price for a drug they negotiate with any other purchaser (subject to certain exceptions) to all states in the Medicaid program.
From CMS News
PFOA Board of Directors
2018-2019
President
Todd Pendergraft

Dirk Andrepont
Ron Robichaux
Vice President
Doug Coyle

Gabriel Guijarro
Ty Stout
Secretary
 Phil Rigsby
Gaye Moseman
John Zuzak

Treasurer
Larry McIntosh

Eric Pusey 

PFOA-MS Board of Directors
President
Dirk Andrepont

Secretary/Treasurer
John Zuzak

David Cole
Phil Rigsby


PFOA-MC Board of Directors
President
Eric Pusey
Vice President

Secretary/Treasurer
Bobbie Barbrey

For Board of Directors contact information, please call 314-843-5977