U.S. Pain submitted letters on three key federal topic this month: a proposed measure for tracking opioid abuse across health plans; the reauthorization of an act on the drug evaluation process; and whether manufacturers should be allowed to communicate about off-label uses of medications.

NCQA proposed measure changes

Last month, U.S. Pain submitted comments to the National Committee for Quality Assurance (NCQA) on a proposal for tracking opioid abuse through the Healthcare Effectiveness Data and Information Set (HEDIS) 2018. HEDIS is a tool used by more than 90 percent of America’s health plans to measure performance in areas of care and service.

The change would measure the rate per 1,000 of members receiving opioid prescription from four or more prescribers during the intake period, and the rate per 1,000 of members receiving prescriptions from four or more pharmacies during the intake period.

“U.S. Pain’s comments encompassed its commitment to protecting access to vital pain management options and preventing pain medication abuse,” says Shaina Smith, director of State Advocacy and Alliance Development. “We believe reform is necessary, but we need to be careful to ensure that reforms don’t unfairly penalize legitimate patients. We want groups like NCQA to be mindful of that.”

The organization’s comments to NCQA also emphasized its support for increasing access to comprehensive, multidisciplinary treatment options, such as massage, chiropractic, physical therapy, etc.

The Prescription Drug User Fee Act (PDUFA)

This month, U.S. Pain was one of many patient groups to urge the reauthorization of Prescription Drug User Fee Act (PDUFA) through a group letter to congressional leadership. Every five years, Congress considers reauthorizing this legislation.

Created in 1992, PDUFA established a process through which the Food and Drug Administration (FDA) collects fees from drug manufacturers to fund the new drug approval process. The idea behind the user fees is that it helps fund additional resources for the FDA to accelerate and enhance the drug approval process. PDUFA also encourages dialogue between the medical product industry and patient communities in the form of a patient-focused drug development program and a rare diseases program.

According to the Information Technology & Innovation Foundation, an independent think tank, PDUFA “enables a safe, timely, and efficient process of drug evaluation while applying best practices in regulatory science that play a foundational part in supporting America’s role as the world’s leader in biomedical innovation.”

This year’s version of the act, PDUFA VI, proposes creating steps which would speed up the advancement of new treatments for patients within the chronic pain community. The latest model would also create advancements and approval of treatments to manage pediatric rare diseases.

If you support the concept of bringing more attention to patient-focused medical advances and increasing efforts in breakthrough therapies, submit a letter to congressional leaders today.

FDA hearing on off-label prescribing

In April, U.S. Pain also responded to the FDA’s request for comment regarding the question of whether manufacturers should be allowed to communicate with consumers about unapproved uses (often referred to as “off-label” uses) of approved medical products.

“The successful use of medications with other label indications for a wide variety of pain conditions has long been a cornerstone of pain treatment,” wrote Cindy Steinberg, U.S. Pain’s national director of Advocacy and Policy, in the letter to the FDA. “We do not believe that manufacturers should be permitted to promote unregulated, off-label indications directly to consumers and patients. However, we would like to suggest a middle ground for FDA to consider.”

In the letter, the organization suggests the FDA contract with a third-party to set-up a database of “moderated” reports and data sharing of off-label use of approved medications and devices. Anyone using the database would need to make their own determination of the accuracy, authenticity, and value of the material reviewed. Many websites already exist for patients to record their experiences with off-label prescribing, but through this approach, FDA could take a proactive, but neutral role.