SCPC Urges Secretary Azar to Address Conflicting Insulin Pen Policy

DATE: June 16, 2020

In a letter to the Secretary of the U.S. Department of Health and Human Services, SCPC warns that conflicting regulatory policy puts patient access at risk and threatens LTC’s good faith efforts to provide insulin pens

Washington, DC –The Senior Care Pharmacy Coalition (SCPC), the only national organization exclusively representing the interests of long-term care (LTC) pharmacies, has sent a letter to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar warning about the conflicting legal and regulatory requirements and interpretations of current health policy concerning insulin pens.

Representing more than 400 LTC pharmacies who serve over 850,000 patients across the country, many of whom live with diabetes, SCPC urged Secretary Azar to convene officials from the Food and Drug Administration (FDA), HHS Office of Inspector General (OIG) and other relevant agencies to work together to clarify insulin pen regulations in order to assure patients’ health, safety, and uninterrupted access to the life-sustaining medications they are prescribed.

Since November 2019, there has been a troubling regulatory conflict that has caused payers, particularly Part D Prescription Drug Plans, to deny pharmacy claims for payment for boxes of insulin pens, which are sometimes necessary to provide a 30-day supply of medication. In settling a case in January 2019, OIG determined that dispensing insulin pens in manufacturer boxes rather than as individual insulin pens constitutes fraud under Medicare, Medicaid, and other federal laws. Yet in November 2019, the FDA updated labeling requirements for insulin pens that specifically prohibit “breaking” a box of pens to dispense in individual units. Because both regulations directly conflict with one another, there has been tremendous confusion that inadvertently opens up LTC pharmacies to compliance concerns. Moreover, payers and pharmacy benefit managers (PBMs) have cited both of these policies for denying claims for insulin pens. At the same time, state Medicaid programs routinely refuse to provide prior approval or pay for dispensing insulin pens by the box.

“LTC pharmacies are caught between directly conflicting regulatory regimes,” SCPC wrote to Secretary Azar. “If they dispense individual pens, they run afoul of FDA instruction.  If they dispense multiple pens in manufacturer boxes, they risk allegations of fraud from the OIG and state Medicaid Fraud Control Units.  In either case, payers have a legitimate basis to deny claims or recoup payments and may simply deny prior authorization for amounts greater than 30-day supplies such that patients would receive no medication at all.  LTC pharmacies also face conflicting interpretations and payment rules among payers and PBMs, while patients may be at greater risk.”

To address these regulatory inconsistencies and ensure patients’ continued access to insulin pens, SCPC urged HHS to develop consistent policies across all relevant agencies, divisions, and other key stakeholders. Until this coordinated response resolves the conflicting regulations, SCPC urges HHS to notify all relevant stakeholders (including payers and PBMs) that LTC pharmacies may dispense insulin pens to patients in LTC facilities either as individual pens or in unopened boxes provided that dispensing decisions are made in good faith and in the best interest of patient care and safety.

“Absent clear, consistent and coordinated instruction from multiple government agencies, patients in nursing homes and other LTC facilities are at medical risk, the LTC facilities in which they reside may be unable to comply with applicable regulations, and the long-term care pharmacies that dispense their medications face potential sanction and adverse financial impact regardless of good faith compliance efforts,”  according to the letter.

“We strongly recommend that you convene all relevant agencies and divisions within those agencies and that you include appropriate stakeholders in such multi-agency/division efforts to assure consistent and effective policies across the Department,” the letter concluded.

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The Senior Care Pharmacy Coalition (SCPC) is the only national organization exclusively representing the interests of LTC pharmacies. Its members operate in all 50 states and serve 850,000 patients daily in skilled nursing and assisted living facilities across the country. Visit seniorcarepharmacies.org to learn more.