50th Anniversary Logo

The American Society for Pharmacy Law (ASPL) is an organization of attorneys, pharmacists, pharmacist-attorneys and students of pharmacy or law who are interested in the law as it applies to pharmacy, pharmacists, wholesalers, manufacturers, state and federal government and other interested parties.

ASPL is a non-profit which encourages diversity & inclusion with the Society, regardless of differing backgrounds, perspectives, experiences, orientations, origins, and practice settings. The Society embraces participation and diversity as it leads to advancing our purpose: 

  • Furthering knowledge in the law related to pharmacists, pharmacies, the provision of pharmaceutical care, the manufacturing and distribution of drugs, and other food, drug, and medical device policy issues;
  • Communicating accurate legal educational information; and
  • Providing educational opportunities for pharmacists, attorneys, and others who are interested in pharmacy law

Latest News

April 30, 2024

CMS FINALIZES LTC FACILITIES STAFFING RULE

CMS has issued its Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting final rule. The final rule governs Medicare- and Medicaid-certified long-term care facilities, and is effective on June 21, 2024.

New institutional payment reporting requirements are included in the final rule, requiring states to report to CMS on the percentage of Medicaid payments for services in nursing facilities and intermediate care facilities for individuals with intellectual disabilities (ICFs/IID) that is spent on compensation for direct care workers (such as nursing and therapy staff) and support staff (such as housekeepers and drivers providing transportation for residents).

CMS did not explicitly include pharmacists into the definition of "direct care worker." In the final rule, CMS clarified that included in the definition should be nurses or other staff who provide clinical oversight and training for direct care staff (as allowed by their professional license), participate in activities directly related to provision of beneficiary care (such as completing or reviewing documentation of care), are qualified to provide services directly to beneficiaries, and periodically interact with beneficiaries. In some instances, CMS recognized that this may also pertain to physicians, physician assistants, or pharmacists who meet the elements of this description of nurses or other staff who provide clinical supervision. However, CMS ultimately declined to add physicians, physician assistants, or pharmacists as additional categories in the definition of direct care worker because CMS wanted to keep the definition focused on the staff that commonly provide most of the direct care in facilities.

Staffing requirements. The final rule stipulates a total nurse staffing standard of 3.48 hours per resident day (HPRD), which must include at least 0.55 HPRD of direct registered nurse (RN) care and 2.45 HPRD of direct nurse aide care. Facilities may use any combination of nurse staff (RN, licensed practical nurse (LPN) and licensed vocational nurse (LVN), or nurse aide) to account for the additional 0.48 HPRD needed to comply with the total nurse staffing standard. CMS also finalized enhanced facility assessment requirements and a requirement to have an RN onsite 24 hours a day, seven days a week, to provide skilled nursing care. The 24/7 RN onsite can be the director of nursing, but must be available to provide direct resident care.

CMS finalized a section titled "pharmacy services," stipulating that the facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement. The section also stated that a facility may permit unlicensed personnel to administer drugs if state law permits, but only under the general supervision of a licensed nurse.

The final rule also stated that the required facility assessment must include services provided, including pharmacy services. Under the final rule, the facility must conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations (including nights and weekends) and emergencies. The facility must review and update that assessment, as necessary, and at least annually. The facility must also review and update this assessment whenever there is, or the facility plans for, any change that would require a substantial modification to any part of this assessment.

CMS argued that this final rule will not negatively impact LTC pharmacy reimbursement. A commenter had expressed concern that the proposed rule would undermine payments for LTC pharmacy services. That commenter argued, for example, that a facility census may decline, resulting in a decrease in the use of pharmacy services and causing various economic challenges for LTC pharmacies. In response to this comment, CMS stated that it disagreed with the assumption that implementation of this rule will result in an overall decline in resident census that undermines reimbursement and affects LTC pharmacy services. CMS argued that the final rule includes multiple flexibilities for eligible facilities located in areas affected by pronounced workforce shortages and provides staggered implementation periods to allow time for additional workforce development to comply with the requirements of this rule.

[Medicare and Medicaid Programs: Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting. Federal Register 22 April 2024 (Display Copy); Fact Sheet: Medicare and Medicaid Programs: Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting Final Rule (CMS 3442-F). Centers for Medicare and Medicaid Services 22 April 2024; Press Releases: Biden-Harris Administration Takes Historic Action to Increase Access to Quality Care, and Support to Families and Care Workers. Centers for Medicare and Medicaid Services 22 April 2024.]