8/29/2017 CMS Mega Rule: Implications for Pharmacists and Pharmacies Curt Wood, RPh, BCGP, FASCP Disclosure and Conflict of Interest Pharmacist Objectives At the conclusion of this program, the pharmacist will be able to: Curt Wood declares no conflicts of interest, real or apparent, 1. Describe the implications of the ‘Mega’ Rule on long- and no financial interests in any company, product, or service term care facilities. mentioned in this program, including grants, employment, gifts, 2. Summarize the implications of the ‘Mega Rule on stock holdings and honoraria. pharmacies/pharmacists. 3. Identify the Phases of the ‘Mega’ Rule and effective dates of each Phase. 4. Identify the additional responsibilities of the consultant pharmacist on Antibiotic Stewardship and Unnecessary Medications. 1
8/29/2017 Technician Objectives Pre-Test Questions At the conclusion of this program, the technician will be 1. T or F: Implementation of the ‘Mega’ Rule was able to: completed on 11/28/2016. 1. Describe the implications of the ‘Mega’ Ruel on long- term care facilities. 2. Summarize the implications of the ‘Mega’ Rule on pharmacists/pharmacies. 3. Identify the Phases of the ‘Mega’ Rule and effective 2. The ‘Mega’ Rule is expected to cost each facility (in dates of each Phase. the first year) an average of: 4. Identify the additional responsibilities of A. $22,900 pharmacists/pharmacies in order to develop B. $42,900 processes to support them in providing the additional C. $62,900 services required by the ‘Mega’ Rule. D. $82,900 Pre-Test Questions 3. Which of the following methods is acceptable for the attending physician to document response to Drug Regimen Review (DRR)? A. Pharmacist writes DRR into Medical Record and Physician CMS Mega Rule: responds directly into medical record. B. Pharmacist writes DRR on separate form, physician writes response on form, then writes a separate note into medical Implications for Pharmacists record. C. Pharmacist writes DRR on separate form, physician esponds and Pharmacies on form and form is placed in medical record. D. All are acceptable. 4. T or F: PRN orders for Alprazolam, Lorazepam, Trazodone or Hydroxyzine (used for anxiety/behaviors) must be limited to 14 days, unless the physician documents the rationale for a longer time frame, and indicates the duration for the PRN order. 2
8/29/2017 Purpose of the ‘Mega’ Rule How Did We Get Here? CMS has stated that they: • CMS first published requirements for long term care (LTC) facilities in the Federal Register on February 2, 1989. • Last comprehensive update occurred September 26, 1991. “…reviewed regulations in an effort to improve the quality of life, care, and services in LTC facilities, • CMS believes that since the last update (1991), optimize resident safety, reflect current professional “…significant innovations in resident care and quality standards, and improve the logical flow of the assessment practices have emerged. In addition, the regulations.” population of LTC facilities has changed, and has become more diverse and more clinically complex. • CMS further states that extensive, evidence-based “These proposals are also an integral part of our efforts research has been conducted and has enhanced to achieve broad-based improvements both in the knowledge about resident safety, health outcomes, quality of health care furnished through federal individual choice, and quality assurance and performance programs, and in patient safety, while at the same time improvement. reduction procedural burdens on providers.” Then Comes the ‘Mega’ Rule! Then Comes the ‘Mega’ Rule! • Sections Revised include: • ‘Mega’ Rule proposed on July 16, 2015 – Resident Rights (483.10) – CMS offered an extended comment period for review of – Facility Responsibilities (483.11) proposed rule by industry leaders and experts, facilites, those working in the industry, and the public. – Freedom From Abuse, Neglect, and Exploitation (483.12) • Final ‘Mega’ Rule published on September 26, – Transitions of Care (483.15) 2016. – Resident Assessments (483.20) – Rewrites all LTC regulations required for participation in – Comprehensive Resident-Centered Care Plans Medicare/Medicaid. (483.21) – Totals 185 pages in the Federal Register. – Quality of Care and Quality of Life (483.25) – Physician Services (483.30) – Nursing Services (483.35) – Behavioral Health Services (483.40) 3
8/29/2017 Then Comes the ‘Mega’ Rule! Phase-In of Regulations • Sections Revised continued: • CMS stated “Given the comprehensive nature of – Pharmacy Services (483.45) the regulatory revisions, it agreed that a longer – Laboratory, Radiology, and Other Diagnostic Services period of time is necessary to implement the (483.50) challenges outlined in this final rule.” – Dental Services (483.55) – Food an d Nutrition Services (483.60) – Specialized Rehabilitative Services (483.65 • The also stated, “In addition, we anticipate that – Outpatient Rehabilitative Services (483.67) additional time will be needed to develop revised – Administration (483.70) interpretive guidance and survey process, conduct – Quality Assurance and Performance Improvement (483.75) surveyor training on the changes and implement – Infection Control (483.80) – Compliance and Ethics Program (483.85) the software changes in the Quality Indicator – Physical Environment (483.90) Survey (QIS) system.” – Training Requirements (483.95) Phase-In of Regulations Better Quality? At What Cost? • Phase 1 went into effect on November 28, 2016. • Federal government estimates initial federal start up costs between $15-20 million and also $15-20 million annually in additional survey costs. • Phase 2 takes effect on November 28, 2017. • CMS expects that complying with the ‘Mega’ Rule will cost facilities $831 million in the first year. That is an average of $62,900 per facility! • Phase 3 takes effect on November 28, 2019. • Projected costs after the first year are estimated at $736 million or $55,000 per facility! 4
8/29/2017 Better Quality? At What Cost? Phase 1 – Focus on Pharmacy • These projected costs are likely to be extremely • Medications Errors: F332 and F333 moved to conservative! – especially in rural areas where Pharmacy Services CFR 483.45. Still requires attracting and keeping qualified staff is less than 5% med errors and residents are free exceedingly difficult. from any significant medication errors. • In addition, failure to comply with the ‘Mega’ Rule • Influenza and Pneumococcal Immunization: F334 will result in compliance issues, penalties, and moved to Pharmacy Services CFR 483.45. fines! Phase 1 – Focus on Pharmacy Phase 1 – Focus on Pharmacy • Drug Regimen Review (DRR): F428 moved to • RECOMMENDATION: Pharmacy Services CFR 483.45. – Facility must have policy and procedure for monthly – Make an extra copy of reports for Medical Director – DRR that includes time frames for different steps in the make sure it is documented that he/she has received process and steps the PHARMACIST must take when and reviewed them! identifying an irregularity that requires urgent action to • Use a separate sheet that states something like “ RECEIPT OF protect the resident. CONSULTANT PHARMACIST’S REPORTS. As Medical Director of this facility, I have received and reviewed the reports from the Consultant Pharmacist for the following months.” – The facility Medical Director must also receive/review • Produce a separate “Executive Summary” report of all DRR’s any irregularities identified by the PHARMACIST. each month. Irregularities are defined as, but not limited to, any drug • Some software programs now provide a signature for the Medical Director for documentation of receipt and review. that meets the criteria for an unnecessary medication. 5
8/29/2017 Phase 1 – Focus on Pharmacy Phase 1 – Focus on Pharmacy • Drug Regimen Review (DRR) continued: • RECOMMENDATION: – Pharmacist writes DRR on separate form, physician responds on form – The attending physician must document in the • Original to be placed in chart or scanned into medical record. resident’s medical record that the identified irregularity • Copy to be maintained in Nursing Office. has been reviewed and what, if any action has been taken to address it. If there is not a change in the medication, the attending physician should document his or her rationale in the resident’s medical record. Phase 1 – Focus on Pharmacy Phase 1 – Focus on Pharmacy • Drug Regimen Review (DRR) continued: • RECOMMENDATION: – The facility must develop and maintain policies and – Policy might state something like “Physician response procedures for the monthly drug regimen review that to DRR will occur within 30 days, or more promptly, if includes, but are not limited to, time frames for the possible.” different steps in the process and steps the pharmacist must take when he or she identifies an irregularity that requires urgent action to protect the resident. • EXPECTATION: CMS is concerned with prescriber response to DRR. It is unclear at this time what CMS Surveyors will deem acceptable. 6
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