news image

June 07, 2015

By Gary A. Puckrein, PhD


June 6, 2015 | BOSTON, MA

Disruption in Access to Diabetes Monitoring Supplies Leads to Increased Hospitalizations, Mortality Among Medicare Beneficiaries 

Data Analysis of CMS Competitive Bidding Program Shows Harm to Patient Care 

Gary A. Puckrein, PhD, president and CEO of the National Minority Quality Forum (NMQF), today will present an award to John Castellani, president of the Pharmaceutical Research and Manufacturers of America (PhRMA), for his demonstrated leadership to increase diversity in clinical trials. On behalf of PhRMA, and in conjunction with NMQF, Castellani spearheaded the “I’m In” campaign to build awareness, start conversations, and increase diversity in clinical trials, especially among African Americans, Asian Americans, and Hispanic populations.

“Through his remarkable leadership in ensuring safety and efficacy testing for new drugs include minority Americans who have traditionally been underrepresented in clinical trials, John Castellani is paving the way for the nation to develop a set of comprehensive guidelines that will, for the first time, reflect the diverse population for whom they serve,” said Gary A. Puckrein, PhD, president and CEO of NMQF.

When a potential new medicine is developed, researchers must prove safety and effectiveness through clinical trials before the medicine is approved by regulatory agencies, such as the Food and Drug Administration. Traditionally, individuals volunteer for clinical trials at the behest of their physicians, but physician referrals alone are often insufficient to attract a large and diverse group of volunteers.

“Despite making up 13 percent of the U.S. population, African Americans only represent about 5 percent of clinical trial participants, and Hispanics, who comprise 17 percent of the U.S., account for a mere one percent of participants,” added Puckrein. “A wide variety of clinical trial participants is critical to adequately assessing whether or not a drug is safe and effective on different populations, and John Castellani is the first person to truly work towards turning the tide on this risky practice.”

The “I’m In” campaign, conceptualized by John Castellani and co-founded by PhRMA and NMQF in March 2014, was created to bridge this awareness gap and encourage minority Americans to participate in clinical trials.

“Only once we include all members of our society in the testing phase of new medicines can we hope to effectively connect patients with the medicines they need, and John Castellani has planted the seed that will get us there,” said Puckrein. 

Gary Puckrein will present the award to John Castellani at the 2015 Leadership Awards Dinner, the culmination of the NMQF Leadership Summit, which was held from April 20-21 at the Ritz-Carlton Hotel in Washington, DC. Organized by NMQF and the Congressional Black Caucus Health Braintrust, the dinner will begin at 6PM tonight with host John Brockington, founder of The John Brockington Foundation, and will feature welcome addresses by Congresswoman Robin L. Kelly, chair of the Congressional Black Caucus Health Braintrust, and Gary A. Puckrein. The keynote address will be delivered by U.S. Representative James “Jim” Clyburn.

About the Competitive Bidding Program 

The Centers for Medicare and Medicaid Services’ (CMS) Competitive Bidding Program (CBP) is mandated by Congress through the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The program required Medicare to replace the fee schedule payment methodology for selected Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) items, such as respiratory devices, mobility equipment and diabetes testing supplies, with a competitive bid process. DMEPOS suppliers must compete to become Medicare contract suppliers by submitting bids, and CMS awards contracts to winning suppliers. The intent of the program is to reduce beneficiary out-of-pocket expenses and save Medicare money while ensuring beneficiary access to quality items and services.


The National Minority Quality Forum received support for the study from Abbott; Acelity L.P. Inc.; LifeScan, Inc., part of the Johnson & Johnson Diabetes Solutions Companies; Roche Diabetes Care; US Healthcare Supply LLC.; and US MED. Portions of the study findings were presented as posters at the American Association of Clinical Endocrinologists 24th Annual Scientific and Clinical Congress, May 13-17, 2015, Nashville, USA; and American Diabetes Association 75th Scientific Sessions, June 5-7, 2015, Boston, USA.

Full Press Release
ADA Poster
ADA Fact Sheet
AACE Poster
AACE Fact Sheet


About The Forum

The National Minority Quality Forum (NMQF) is a 501(c)(3) not-for-profit, non-partisan, independent research and education organization. The vision of NMQF is a health services research, delivery and financing system that provides quality and effective health services to the biodiverse American general population of the 21st century. NMQF helps assure that national and local quality improvement initiatives are informed by scientific evidence, and place a priority on the quality of care and patient outcomes in all populations.

Media Contact

Gretchen C. Wartman, VP Policy and Program | 202.223.7560