(Updated Tuesday, April 6, 2021, 4:00 p.m. EDT—Individuals who were among CV340B’s Notable Women of 340B were excluded from the original version of this article. They have been added to the list at the end.)
Women have played a key role in the 340B program since its inception nearly 30 years ago. Their historic and ongoing involvement was observed and celebrated in “Notable Women of 340B,” a webinar broadcast by Community Voices for 340B (CV340B) last week as Women’s History Month came to a close.
All of the panelists were women prominent in 340B government affairs and program management—Colleen Meiman, a national policy advisor for community health centers; Peggy Tighe, principal at 340B law firm Powers Pyles Sutter & Verville; Lorrie Carr, CEO of Avita Pharmacy; and Colleen DiClaudio, founder and president of 340Basics. Marilyn Hayes, regional sales director for Tango340B, moderated the hour-long event. (Powers Pyles, 340Basics, Avita, and Tango340B are 340B Report sponsors.)
Hayes noted that 340B has long been a magnet for women. The panelists agreed, noting that it tended to reflect their relationship to the health care system in general.
“As a mom of four I can confirm that women are generally the health care consumers, and certainly caretakers,” Carr said. She added that, given that 12 states have yet to expand Medicaid eligibility under the Affordable Care Act, access to care can be extraordinarily difficult for lower-income families and their children.
“Without the (340B) funding, there wouldn’t be any community health centers to provide low or no-cost prescriptions, medical benefits, access to food, transportation and many other services that exist because of this program,” Carr said.
Meiman noted that 340B is a way of providing care, particularly among a generation of women who have had far more opportunity to be involved in health care delivery and policy beyond being nurses. “Working in this field is a way of trying to make a more fair and equitable and kind society,” she said.
DiClaudio said she has been extremely gratified by the growth of 340B over the years and what it has accomplished. “More and more patients now can get the drugs that they need in the communities they live in, without limited access,” she said. “It’s a pleasure to be in this space, and I’m super passionate about it.”
The panel discussed the contributions of 30 women (see list below) who have been key to the program’s formation in the early 1990s to the present day. Among the most important pioneers are Marsha Simon, a former staffer for U.S. Sen. Ted Kennedy (D-Mass.), who was instrumental in putting together and helping to pass the legislation that created the program, and Kathy McGee, deputy to former U.S. Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) Director Jimmy Mitchell.
“Jimmy Mitchell was the face of the program, but Kathy McGee was the person you always reached out to,” Meiman said. “She was the person who just helped you figure out how things are working.”
Public Health Service Rear Adm. Krista Pedley, Mitchell’s successor at OPA, is considered perhaps the most important woman in 340B today.
Also lauded were nine lawmakers who have played key roles in tweaking and funding 340B. Although eight of them are Democrats, Sen. Shelly Moore Capito (R-W.V.), received particular praise from Tighe. She noted that 340B has taken a partisan bent in recent years and that Moore Capito’s willingness to advocate for the program was brave.
“For Shelley Moore Capito to come in and say ‘this matters for my people in West Virginia and I’m going to stand up for this program,’ is a very big deal,” Tighe said.
Although the panelists acknowledged that 340B is under pressure from many directions, Carr said she is “extremely optimistic” about its future, adding there are enough competent policymakers and advocates to ensure its problems are resolved.
Carr spent the first half of her career in the pharmaceutical industry involved in drug pricing and market access, and later served as a vice president for specialty drug sales and strategy at Walgreens, giving her a broad perspective on 340B.
Drug manufacturers support 340B, Carr said. They just do not want to have to pay multiple drug discounts. Meiman said there is more common ground in 340B than there might appear to be at first glance, especially if the issue of pharmacy benefit managers attempting to “pickpocket” covered entities’ 340B discounts was taken care of.
“There are outliers, but everybody’s intending to do the right thing,” Carr said, later noting that she is hopeful that advocates will not only protect the program over the long-term, “but that we can find a way to get to a good place where…the finger-pointing and vilification of the system goes away.”
Key Women of the 340B Program
340B Program Groundbreakers
Mary Lou Anderson, Public Health Advisor/Deputy Director of HRSA
Freda Mitchem, Associate VP of Policy for National Association of Community Health Centers
Kathy McGee, Former Deputy, Office of Pharmacy Affairs, HRSA
Marsha Simon, former staffer for Sen. Ted Kennedy, D-MA. Currently President, M.J. Simon and Company
Key Figures in the Early Days of 340B
Marsha Alvarez, Director, Office of Drug Pricing Program
Mary Wakefield, former HRSA Administrator
Lisa Scholz, Senior VP, market strategy, Sentry Data Systems; formerly served with HRSA’s Pharmacy Services and Support Center and 340B Health
Lisa Sokol, VP, marketing and customer success, Apexus
Key Senators
Patty Murray, D-WA
Debbie Stabenow, D-MI
Tammy Baldwin, D-WI
Shelley Moore Capito, R-WV
Key Representatives
Diana DeGette, D-CO
Cindy Axne, D-IA
Anna Eshoo, D-CA
Abigail Spanberger, D-VA
Doris Matsui, D-CA
Key HRSA/HHS/ Personnel and Policymakers
Rear Adm. Krista Pedley, Director of HRSA’s 340B program
Katheryne Richardson, VP of 340B policy and compliance, Apexus
Dr. Marcella Nunez-Smith, Assistant Professor of Medicine, Yale University; member of COVID-19 Task Force
Kimberly Espinosa, HHS Deputy Assistant Secretary for Legislation
Rachel Pryor, Counselor for Health Policy, Office of the HHS Secretary
Liz Fowler, Deputy Administrator and Innovation Director, Centers for Medicare & Medicaid Services
340B Related Associations
Shannon Stephenson, President, RWC-340B
Colleen Meiman, National Policy Advisor, NACHC
Beth Feldpush, Senior VP of Policy and Advocacy, America’s Essential Hospitals
Erin O’Malley, Senior Director of Policy, America’s Essential Hospitals
Maureen Testoni, President and CEO, 340B Health
Kathryn DiBitetto, VP of Government Relations, 340B Health
Stephanie Arnold-Pang, Director, Policy and Government Relations, National Coalition of STD Directors
Mindy McGrath, Sr. Director, Advocacy & Communications
CV340B Board Members
Lorrie Carr, CEO, Avita Pharmacy
Colleen DiClaudio, President/Founder, 340Basics
Leah Bailey, General Counsel, Maxor National Pharmacy Services
CV340B Advisory Committee
Naseema Shafi, CEO, Whitman-Walker Health, Washington, D.C.
Sima Shah, 340B Program Director at Howard Brown Health, Chicago
Sue Veer, President and CEO, Carolina Health Centers
340B Legal & Regulatory
Ellen Riker, Principal, Artemis Policy Group
Barbara Straub Williams, Principal, Powers Pyles Sutter & Verville
Amy Yenyo, Assistant Director, Public Policy Division at Planned Parenthood Federation of America
Issie Karan, Principal, Artemis Policy Group
