CMS Pharmacy and Medication; Complying with the Hospital CoPs and Changes

If a surveyor showed up at your hospital today, would you be prepared? Are you up to speed with the new antibiotic stewardship requirements and pharmacy’s involvement in the new regulations under the Hospital Improvement Rule which became final on November 29, 2019? The interpretive guidelines and survey procedure will be issued in 2020. The CDC issued revised core elements for the hospital antibiotic stewardship program in November of 2019.

CMS also has a new website to locate the hospital CoP manual and a new email to address questions and information on both of these will be provided.

In 2020, CMS is also removing all references to the USP standards. They have included a requirement to follow all national standards of practice and the evidence-based literature.

CMS rewrote 10 of the 18 tag hospital pharmacy sections on November 20, 2015, and many hospitals are still struggling with compliance. There has been increased scrutiny of the standards and an increase in the number of deficiencies for hospitals. This should be on the radar screen of all hospitals. This includes changes regarding the compounding of sterile medication and the beyond-use date (BUD) and bringing them into alignment with the acceptable standards of practice. The language was included to allow the surveyor to cite the hospitals at either the standard or condition level.

There have been many recent changes in the nursing section that address medication usage also. This includes changes to the timing of medication, self-administered medication, compounding, blood, and safe opioid use.  There are three-time frames that medications must be administered along with the QAPI requirements. These will be provided as additional resources. There will also be additional resources.

The OIG recommended surveyor training and the evaluation of 55 things in addition to revising the pharmacy standards which was done. More educated surveyors can increase the chances of finding a deficiency. The surveyor may ask for the contract if the hospital outsources compounding.

Did you know the most common medical error in hospitals today is medication errors? CMS said that drug-related adverse outcomes occur in 1.9 million inpatient stays which is almost 5% of all admissions. There are also 838,000 patients a year who are treated as an outpatient who has a drug-related adverse event. Hospitals that spend more resources on medication issues generally have lower rates.

Just about every hospital in America accepts Medicare and Medicaid reimbursement and as such must follow the Center for Medicare and Medicaid Services (CMS) hospital interpretive guidelines. These regulations and interpretive guidelines must be followed for all patients in the hospital.

Information will be provided on the top problematic pharmacy standards by CMS. CMS is now issuing a deficiency report showing when the pharmacy is cited for being out of compliance. This program is a must to help ensure compliance with the hospital CoPs.

It is important for nursing to understand the medication and pharmacy standards since many of them apply to the nurse. For the first time, CMS mentions that nursing needs to be aware of some of the pharmacy standards and vice versa. This includes medication errors, adverse events, drug incompatibilities, self-administered medication, and required medication policies. If a medication error or ADE occurs there must be notification of the physician, documentation in the medical record and it must be included in the PI data.

The timing of medication requires policies and procedures and training by hospitals. This section requires notification of the physicians and discusses when this must occur. Hospitals should have a non-punitive approach and the definition of medication error should be broad enough to include near misses.

The CMS interpretive guidelines address medication management and pharmacy-related standards. These can be looked at when CMS conducts a complaint or validation survey. Medication management is not only a big issue with CMS but also with the Joint Commission. Medication errors are the largest number of medical errors in healthcare today. They are also the most common reason for unnecessary readmissions to the hospital.

It is essential that hospitals work together to implement and follow these regulations. Problematic standards include verbal orders for medication, order for medications, and standing orders.

• Recall that all hospitals that receive Medicare/Medicaid reimbursement must follow the medication guidelines for all patients
• Discuss that CMS has requirements  on BUD and compounding
• Recall that CMS has a number of required pharmacy policies and procedures
• Describe that CMS requires a policy for high-risk drugs such as double-checks or dose limits.

• Pharmaceutical Services requirements
  • Qualified pharmacy director
• How to locate the CMS manual
• How to email questions directly to CMS
• OIG Report on Oversight of Compounded Pharmaceuticals Used in Hospitals
  • 55 areas surveyors should look at
  • ASHP and ISMP on compounding
• Additional resources will be available and will be discussed briefly
  • CMS final infection control worksheet: safe injection practices, microbial stewardship, and MDRO
  • Final changes: antibiotic stewardship program requirements and new CDC core elements
  • ISMP IV Push Guidelines
  • CMS and TJC Antimicrobial standards and issues
• Ten final tag number changes
• CDC vaccine storage document
• Common problematic pharmacy standards
• Standards of care
  • ISMP, USP, ASHP, APA, FDCA, etc.
• Recent CMS Memos: safe injection practices, infection control breaches, Luer misconnections, insulin pens
• CMS 45 page memo regarding pharmacy and medication changes and changes final now
• Nursing tag 405 and additional resource
  • Compounded medications and BUD
  • Safe injection practices
  • Compounded sterile preparations(CSP)
  • Immediate-use CSP and one hour rule
• Meeting the needs of patients
  • What is included in pharmaceutical services?
  • Medications must be available timely
• Condition or standard level deficiencies
• Medications timing changes
• MS role in developing P&P including minimizing drug errors
• Functions of pharmacist
• Required P&P
• Flag new types of medication errors
• High alert medication
• Limiting the number of medication-related devices
• Pharmacist on call if not open 24 hours
• Standardization of prescribing and communication practices
• Weight-based dosing
• Availability of patient-specific information
• Abbreviations, look alike-sound alike drugs
• Pre-printed order sheets
• The voluntary non-punitive reporting system
• Weight-based dosing for the pediatric population
• Incorporation external alerts
• P&P required by hospitals
• Policy to minimize drug errors
• Storage of drugs
• Pharmacy director role in P&P
• Drug storage of medications and biologicals
• Dispensing and administration of medications
• Pharmacist job description
• Pharmacy personnel requirements
• First review of new medications by pharmacy
• Policy to address medications brought in
• Monitoring effects of medications
• Investigation drug policy
• Recalled or discontinued drugs
• Compounding of drugs
  • The Drug Quality and Security Act (DQSA)
  • Outsourcing facilities
  • Use of compounding pharmacies
  • Medications compounded by the hospital pharmacy
  • Compounding practices and quality control
  • BUD, packaging, and labeling of medications
• Locked storage areas
• OR anesthesia carts and ASA guideline
• Medication and crash carts
• Patient self-administration of drugs regulation
• Outdated or mislabeled drugs
• When a pharmacist is not on duty
• Night cabinet standard
• Automated stop orders and policy
• Medication error and near misses
• Proactively identify medication errors
• Indicator or trigger drug review
• Drug interaction information
• Formulary

This program is for anyone involved in the medication process especially pharmacists, chief pharmacy officers, physicians, all nurses, patient safety officers, nursing supervisors, nurse managers, and others. Risk managers, hospital attorneys, compliance officers, Joint Commission coordinators, and quality and performance improvement staff, chief nursing officer, chief medical officer, chief operation officer, policy and procedure committee members, case managers, nurse educators, nurse managers, compliance officer, director of regulations, Joint Commission director and others who participate in the mediation process should attend.