An updated Interpretive Guidance (IG) was issued by the Centers for Medicare & Medicaid Services (CMS) on July 5, 2017 that has far-reaching implications for long-term care facilities (LTCFs) and the pharmacists and pharmacies that provide services to residents. The IG revisions come more than nine months after CMS released a final rule in October 2016 that implemented a major overhaul of Medicare and Medicaid requirements for participation for LTCFs.1,2 The final rule establishes a three-part phase-in, with Phase 1 effective November 28, 2016, Phase 2 effective November 28, 2017 and Phase 3 effective November 28, 2019. The IG, which will be used by all nursing home survey teams beginning November 28, 2017, includes significant restructuring of the survey process as well as new requirements with an emphasis on patient-centered care.
While CMS develops the IG to guide surveyors with facility survey protocols and processes, LTCFs and their affiliated providers use it to ensure they understand how they will be evaluated and what elements will be included on a survey. The new IG represents the most significant revision to LTCF requirements in over 25 years, presenting a steep learning curve for surveyors and providers alike. Fortunately, since the final rule was released in 2016, all affected parties will have the advantage of over a year’s time to learn and understand the new requirements.
CMS wisely announced a one-year delay in enforcement for some of the provisions to allow LTCFs to adapt to the new requirements and processes. In a memo accompanying the IG release, CMS stated, “Specifically, we will not utilize civil money penalties, denial of payment, and/or termination. Should a facility be found to be out of compliance with these new requirements beginning in November of 2017, CMS would use this year-long period to educate facilities about certain new Phase 2 quality standards by requiring a directed plan of correction or additional directed in-service training.”3 The list of specific Phase 2 requirements associated with the one-year enforcement delays will be shared by CMS at a later date. CMS intends to enforce all other existing standards (including requirements from November 2016) through the standard process.
In another positive development, CMS will maintain the Five-Star Quality Rating of each facility at its pre-November 2017 rating so the phase-in process will not have a negative impact. This transitional policy is intended to allow facilities to adapt to the new requirements.
Key Areas of Interest
The IG includes a series of changes for pharmacy services, organized in four sections: Drug Regimen Review (F756); Unnecessary Medications (F757); Psychotropic Medications (F758); and Infection Control Program (F945).
Under the requirements, a pharmacist must perform a drug regimen review (DRR) for each resident at least once a month. In addition to the attending physician and director of nursing, CMS now requires the facility’s medical director to obtain a copy of the DRR. Facilities must also develop policies and procedures concerning the DRR, including timeframes, pharmacist procedures and notification procedures.
The rules also require a resident’s drug regimen be free of unnecessary drugs. CMS defines an unnecessary drug as any drug when used in: excessive dose (including a duplicate drug); excessive duration; without adequate monitoring; without adequate indication for its use; in the presence of adverse consequences, which indicate the dose should be reduced or discontinued; or any combination of these conditions.
Focus on Psychotropic Medications
Under Phase 2, CMS makes broad changes regarding the use of psychotropic drugs in an effort to ensure residents receive these drugs only when appropriate. Changes include revisions to the requirements to refer to “antipsychotic” drugs as “psychotropic” drugs and define “psychotropic drug” as any drug that affects brain activities associated with mental processes and behavior. These drugs include the following categories: antipsychotic, antidepressant, antianxiety and hypnotic. Based on the comprehensive assessment of a resident, the facility must ensure that residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record. Residents who receive psychotropic drugs must receive gradual dose reductions (GDRs) and behavioral interventions, unless otherwise contraindicated, in an effort to discontinue use.
The requirements also restrict PRN (or as needed) orders for psychotropic drugs. Residents may not receive PRN orders for psychotropic drugs unless the drug is intended to treat a condition that is documented in the clinical record. Those PRN orders are limited to 14 days, unless the prescriber believes it is appropriate to extend the order beyond 14 days and documents this in the clinical record. The requirements restrict PRN order renewal beyond 14 days, unless the prescriber has evaluated the resident for the appropriateness of the medication. The prescriber is required to write a new PRN script every 14 days after the resident has been evaluated, if the prescriber believes the resident requires an antipsychotic drug on a PRN basis for longer than 14 days.
Pharmacists and pharmacies will also play a key role in new requirements that facilities have an infection prevention and control system in place that includes an Antibiotic Stewardship Program (ASP). An ASP must include antibiotic use protocols and a system to monitor antibiotic use. According to CMS, the ASP should include leadership support and accountability via the participation of the medical director, consulting pharmacist and nursing and administrative leadership. The requirement is intended to ensure each facility: develops and implements protocols to optimize the treatment of infections; reduces the risk of adverse events, including the development of antibiotic-resistant organisms, from unnecessary or inappropriate antibiotic use; and develops, promotes and implements a facility-wide system to monitor the use of antibiotics. In addition, facilities must establish a process for providing feedback to prescribing practitioners regarding antibiotic resistance data, their antibiotic use and compliance with facility antibiotic use protocols. To help guide facilities in the development of an ASP, the IG references the Centers for Disease Control and Prevention’s (CDC) core elements for antibiotic stewardship in nursing homes, which include: facility leadership commitment to safe and appropriate antibiotic use; appropriate facility staff accountable for promoting and overseeing antibiotic stewardship; and accessing pharmacists and others with experience or training in antibiotic stewardship.4
The IG places an emphasis on antibiotic stewardship during patient transfers, calling for reviewing and monitoring: when the resident is new to the facility; when a prior resident returns or is transferred from a hospital or other facility; and during each monthly medication regimen review when the resident has been prescribed or is taking an antibiotic. When a resident is discharged, the discharge summary must include the resident’s disease diagnoses and health conditions, course of illness/treatment or therapy, medications and pertinent labs, radiology and consultation results and instructions or precautions for ongoing care.
These new changes for antibiotic use mean surveyors will be making a comprehensive review of nursing home procedures and documentation to ensure antibiotics are prescribed for the correct indication, dose and duration to appropriately treat the resident while also attempting to reduce the development of antibiotic-resistant organisms.
The Road Forward
Taken together, the comprehensive reform to the IG creates new opportunities for pharmacists and pharmacies to work with LTCFs and their residents to ensure appropriate medication use. Facilities are likely to lean heavily on the expertise of pharmacists to support more frequent DRRs, reduce inappropriate drug use and implement processes to closely manage the use of psychotropic and antibiotic medications. While the far-reaching breadth of the updated IG will challenge facilities and providers to adapt to the expanded scope of surveys, the sensible decision by CMS to delay some civil money penalties, denial of payment and/or termination, should help facilities navigate the changes.
Brad Kile is president of the Dumbarton Group, LLC, an advocacy and policy firm.
1 Medicare State Operations Manual. P – Survey Protocol for Long-Term Care Facilities and PP – Interpretive Guidelines for Long-Term Care Facilities. Centers for Medicare & Medicaid Services. n.d. Web. 4 Aug. 2017. www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107_Appendixtoc.pdf
2 Federal Register. Centers for Medicare & Medicaid Services. CMS–3260–F. Medicare and Medicaid Programs; Reform of Requirements for Long Term Care Facilities. October 4, 2016. Web. 4 Aug. 2017. www.gpo.gov/fdsys/pkg/FR-2016-10-04/pdf/2016-23503.pdf
3 Revision to State Operations Manual (SOM) Appendix PP for Phase 2, F-Tag Revisions, and Related Issues. Centers for Medicare & Medicaid Services. July 30, 2017. Web. 4 Aug. 2017. www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Downloads/Survey-and-Cert-Memo-Revision-SOM-Appendix-PP-Phase-2.pdf
4 The Core Elements of Antibiotic Stewardship in Nursing Homes. Centers for Disease Control and Prevention. Feb. 28, 2017. Web. 4 Aug. 2017. www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html