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Pharmacy groups says 'lock-in' provision is problematic

May 1, 2015
by Lois A. Bowers, Senior Editor
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ASCP comments

The American Society of Consultant Pharmacists told Long-Term Living that it “believes this proposal is unwise, as it has the potential to disrupt the availability of necessary pain medication to vulnerable seniors who reside in long term care and other types of facilities. CMS has recognized that the national practice and standard of care is for a single nursing facility to be served by a single institutional long term care pharmacy. These institutional pharmacies are experienced in maintaining accountability for narcotics. They follow specific regulations and practices, along with the facilities they service, in order to provide a safe and effective system for monitoring and providing pain medications to the residents of facilities. Because of the regulatory systems already in place in this area of healthcare, we feel that pharmacies serving nursing facilities are already part of a safe system for handling controlled dangerous substances.”

Seniors’ access to medications in skilled nursing facilities (SNFs) and other long-term care (LTC) facilities could be restricted inadvertently under a Medicare Part D “lock-in” provision contained in a bill under consideration, the Senior Care Pharmacy Coalition (SCPC) has told the U.S. House of Representatives’ Energy and Commerce Committee Health Subcommittee.

The “21st Century Cures” legislation has a goal of helping to reduce drug abuse among Prescription Drug Plan (PDP) Part D beneficiaries. SCPC says that goal is commendable, but the group says that the provision would cause problems for Part D beneficiaries living in LTC facilities because such facilities and pharmacies already must satisfy more stringent safeguards than the legislation would establish.

“The SCPC supports the committee’s goals of improving Medicare Part D through fraud and abuse prevention efforts, and of reducing prescription drug abuse and diversion among Part D beneficiaries,” SCPC President and CEO Alan G. Rosenbloom said in a statement submitted for the record for an April 30 hearing. “However, we are concerned that the PDP Drug Safety Program established in section 3151 of the bill does not recognize the specialized capacity of LTC pharmacies to prevent potential abuse of controlled substances.”

Because of the differences between retail and LTC pharmacies, Rosenbloom said, the provision as drafted would pose significant quality of care and compliance issues for LTC pharmacies and LTC facilities, particularly SNFs. “More importantly, section 3151 inadvertently could...undermine Medicare beneficiary choice in selection of an LTC facility.”

The SCPC represents companies that own and operate independent LTC pharmacies in more than 40 states, serving more than 350,000 patients and residents in SNFs and assisted living communities every day. LTC pharmacies are in a unique position to ensure the integrity of the Part D program, Rosenbloom said. “As contracted pharmacies servicing LTC facilities, our members’ pharmacists already have oversight of patients’ entire drug regimens. The statutory and regulatory requirements imposed by Medicare on LTC pharmacies—as well as the methods of packaging, dispensing and tracking medications and monitoring usage in LTC facilities—mean that LTC pharmacies already satisfy higher standards than those section 3151 would impose on pharmacies in any safe pharmacy network.”

Among requirements already in place, according to the SCPC:

  • Extensive pharmacy operations and prescription services;
  • Around-the-clock delivery;
  • 24-hour on-call pharmacists, including many pharmacies that open and staffed 24 hours a day, seven days a week; 
  • Emergency medications;
  • Specialized packaging;
  • Comprehensive inventory;
  • Capacity to comply with the reporting requirements necessary to provide these services.

In addition, Rosenbloom said, Medicare and Medicaid conditions of participation for LTC facilities require that their pharmacies oversee and manage all medications for each patient or resident receiving care and services in the facility.

With respect to narcotics:

  • LTC pharmacists and licensed LTC facility staff use count sheets to track every dose of narcotics prescribed and administered.
  • LTC pharmacists and licensed LTC facility staff conduct regular narcotic audits to ensure compliance.
  • Orders and reorders of narcotics are handled by LTC pharmacists and licensed facility staff, not the Medicare beneficiaries themselves. 

The final bill should exempt certain individual Part D beneficiaries living in settings in which pharmacy access already is highly controlled, the SCPC recommended to the committee. “SCPC’s desired clarification will ensure that Part D beneficiaries in LTC facilities are not inadvertently prohibited from access to needed medications when they transition into or out of the LTC facility or reside there,” Rosenbloom concluded.