Five-Star Rating System: How to Prepare Your Pharmacy Donna K. Thiel Partner King & Spalding, LLP Washington, DC
Star Rating: Active Purchasing The Centers for Medicare and Medicaid Services (CMS) put in place the Five-Star Quality Rating System to help educate consumers on quality and make quality data more transparent The Medicare Star Rating system is part of CMS s efforts to define, measure, and reward quality health care The Nursing Home Compare website now features a quality rating system that gives each nursing home a rating of between 1 and 5 stars Nursing homes with 5 stars are considered to have above average quality and nursing homes with 1 star are considered to have quality below average
Star Ratings: Nursing Homes Concern that the rankings may raise unrealistic expectations for consumers, anticipating the same 5-Star service from a nursing home as would be provided at a correspondingly-rated luxury resort The rankings may also cause consumers to avoid facilities that might otherwise be ideally suited for their loved one All meet Medicare minimum criteria for certification
Limitations of CMS's Health Inspection Database Includes the nursing home characteristics and health deficiencies issued during the three most recent state inspections and recent complaint investigations Data about staffing and penalties levied against nursing homes also come from this database All data are reported by the nursing homes themselves. Nursing home inspectors review it, but don t formally check it to ensure accuracy. This information changes frequently as residents are discharged and admitted, or residents' conditions change The information should be interpreted cautiously and used along with information from the Long Term Care Ombudsman's office, the state survey agency, or other sources
Consensus Criteria? Snap-shot evaluation of a nursing facility akin to restaurant and hotel rating programs has drawn criticism Not an independent reviewing organization, the system results in a ranking from the United States federal government No opportunity for consumer input Much of the ranking left to the subjectivity of federal surveyors
August 24, 2014
McKnights
NY Times Editorial AUG 26, 2014 -Editorial underscores major flaws in Medicare's rating system for nursing homes, particularly its overreliance on self-reporting by nursing homes; calls for improvements in rating system
How are the Five-Star Ratings Calculated? Methodology for Constructing the Ratings https://www cms gov/medicare/provider-enrollment-and- Certification/CertificationandComplianc/downloads/usersguide pdf
SNF Five Star Rating There is one overall 5-Star rating for each nursing home, and a separate rating for each of the following three sources of information: Health Inspections The health inspection rating contains information from the last 3 years of onsite inspections, including both standard surveys and any complaint surveys Staffing The staffing rating has information about the number of hours of care on average provided to each resident each day by nursing staff Quality Measures The quality measure rating has information on 9 different physical and clinical measures for nursing home residents
Step 1: Health Inspection Domain Nursing home that participates in the Medicare or Medicaid program have an onsite standard comprehensive survey annually Surveys are unannounced and are conducted by a team of health care professionals Certification surveys provide a comprehensive assessment of the nursing home, including assessment of such areas as medication management, proper skin care, assessment of resident needs, nursing home administration, environment, kitchen/food services, and resident rights and quality of life
Health Inspections: Interpretive Guidance Compliance with the survey process and requirements established by CMS and published in the State Operations Manual (SOM) is the primary regulatory focus for nursing facilities and consultant pharmacists Any deficiency cited against the facility will result in regulatory and/or monetary penalties to the facility, will become a part of the public record about the facility, and may reflect poorly on the providers and facility
Synopsis of The Pharmaceutical Services, Procedures and Consultation The Pharmaceutical Services, Procedures and Consultation requirement has four aspects First, the facility must provide routine and/or emergency medications and biologicals or obtain them under an agreement described in 42 CFR 483 75(h) Second, the facility must have procedures for pharmaceutical services to meet the resident's needs The procedures must assure accurate acquisition, receipt, dispensing, and administration of all medications and biologicals Third, the facility must have a licensed pharmacist who provides consultation and oversees all aspects of the pharmaceutical services Fourth, the facility must follow applicable laws and regulations about who may administer medications
Pharmaceutical Services Procedures These procedures address, but are not limited to, Acquiring; Receiving; Dispensing; Administering; Disposing; Labeling and storage of medications; and Personnel authorized to access or administer medications
Acquisition of Medications Examples of procedures addressing acquisition of medications include: Availability of an emergency supply of medications, if allowed by state law, Location of the supply; personnel authorized to access the supply; record keeping; monitoring for expiration dates; and the steps for replacing the supply when medications are used; When, how to, and who may contact the pharmacy regarding acquisition of medications and the steps to follow for contacting the pharmacy for an original routine medication order, Transportation of medications from the dispensing pharmacy consistent with manufacturer's specifications, State and federal requirements, and Standards of professional practice to prevent contamination, degradation, and diversion of medications
Receiving Medication Examples of procedures addressing receipt of medications include: How the receipt of medications from dispensing pharmacies (and family members or others, where permitted by state requirements) will occur and how it will be reconciled with the prescriber's order and the requisition for the medication; How staff will be identified and authorized in accordance with applicable laws and requirements to receive the medications and How access to the medications will be controlled until the medications are delivered to the secured storage area;
Dispensing Medication Examples of procedures to assure compatible and safe medication delivery, to minimize medication administration errors, and to address the facility's expectations of the in-house pharmacy and/or outside dispensing pharmacies include: Delivery and receipt; Labeling; and The types of medication packaging (eg, unit dose, multi-dose vial, blister cards)
Administering Medications Examples of procedures for administering medications include: Defining general guidelines for specific monitoring related to medications, when ordered or indicated, including specific items to monitor (e.g., blood pressure, pulse, blood sugar, weight), frequency (e.g., weekly, daily), timing (before or after administering the medication); Defining pertinent techniques and precautions for administering medications through alternate routes such as eye, ear, buccal, injection, intravenous, atomizer/aerosol/inhalation therapy, or enteral tubes; Clarifying any order that is incomplete, illegible, or presents any other concerns, and Reconciling medication orders including telephone orders, monthly or other periodic recapitulations, medication orders to the pharmacy, and medication administration record
Disposition of Medications Examples of procedures addressing the disposition of medications include: Timely identification and removal (from current medication supply) of medications for disposition; Identification of storage method for medications awaiting final disposition; Control and accountability of medications awaiting final disposition consistent with standards of practice; Documentation of actual disposition of medications to include: Resident name Medication name Strength, prescription number quantity, date of disposition Involved facility staff
Authorized Personnel The facility assures that all persons administering medications are: Authorized according to state and federal requirements, Oriented to the facility's procedures, and Have access to current information regarding medications being used within the facility, including side effects of medications, contraindications, dosages Examples of procedures addressing authorized personnel include: How the facility assures ongoing competency of all staff (including temporary, agency, or on-call staff) authorized to administer medications and biologicals; Identifying pharmacy personnel in addition to the pharmacist (e g, pharmacy technicians, pharmacist assistants) who are authorized under state and federal requirements to access medications and biologicals
Contributing To SNF Quality The standards of practice are designed to fulfill federal mandates to: Decrease medication errors and adverse drug events Assure proper medication selection Monitor drug interactions, over-medication, and under-medication Improve the documentation of medication administration The LTC pharmacy can: Perform in-house mock surveys Check medication carts Ensure that drugs are stored correctly and not expired Assist with policies and procedures
Drug Disposal SNFs struggle with proper disposal of unused medications, especially those that operate in states without return regulations Offer technology-solutions or process suggestions tailored to the individual facility
Step 2: Quality Measure Domain A set of quality measures has been developed from Minimum Data Set (MDS)-based indicators to describe the quality of care provided in nursing homes. These measures address a broad range of functioning and health status in multiple care areas The measures were selected based on their validity and reliability, the extent to which the measure is under the facility s control, statistical performance, and importance Data for quality measures come from the MDS Repository The MDS is an assessment done by the nursing home at regular intervals on every resident in a Medicare- or Medicaid-certified nursing home. These data are used by the nursing home to assess each resident's needs and develop a plan of care.
Long-Stay Residents Percent of residents whose need for help with activities of daily living has increased Percent of high risk residents with pressure sores Percent of residents who have/had a catheter Percent of residents who were physically restrained Percent of residents with a urinary tract infection Percent of residents who selfreport moderate to severe pain Percent of residents experiencing one or more falls with major injury Short-Stay Residents Percent of residents with pressure ulcers(sores) that are new or worsened Percent of residents who self-report moderate to severe pain https://www cms gov/medicare/quality-initiativespatient-assessmentinstruments/nursinghomequalityin its/downloads/mds30qm-manual pdf
Targeted Education LTC pharmacy often plays a major role in educating a facility s medical team on over-the-counter and prescriptions drugs effects on geriatric patients Inform medical staff on how medications may be causing persistent health issues Performance measures that could be improved with pharmacist support. These include: Annual influenza vaccine Cardiovascular care cholesterol screening Care for older adults medication review Care for older adults pain screening Colorectal cancer screening Diabetes care cholesterol screening Diabetes care eye exam Osteoporosis management
Readmissions Section 3025 of the Affordable Care Act added section 1886(q) to the Social Security Act establishing the Hospital Readmissions Reduction Program, which requires CMS to reduce payments to IPPS hospitals with excess readmissions, effective for discharges beginning on October 1, 2012 Defined readmission as an admission to a: Hospital within 30 days of a discharge from the same or another subsection(d) hospital; Adopted readmission measures for the applicable conditions of Acute Myocardial Infarction (AMI), Heart Failure (HF) and Pneumonia (PN); In the FY 2015 IPPS Final Rule, CMS has made refinements to the readmissions measures CMS is finalizing to include two additional readmissions measures, COPD and THA/TKA in the calculation of a hospital s readmissions payment adjustment factor
Readmissions Patients are often prescribed new medications when released to a community after a hospital stay The resident may not know how to use new medications or they may negatively interact with other drugs in the regimen, causing adverse effects that can lead to hospital readmissions By ensuring proper medication use and administration, the LTC pharmacy can help facilities stop the revolving door of hospital readmissions in healthcare
Quality of Care 42 CFR 483.25 Antipsychotic Drugs Based on a comprehensive assessment of a resident, the facility must ensure that: (i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and (ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs
Antipsychotic Medication Use in Nursing Facility Residents An estimated half of nursing facility residents have some form of dementia, many of whom experience behavioral and psychological symptoms associated with dementia Over 25% of patients in nursing facilities in the United States receive antipsychotic medications, according to data from the Certification and Survey Provider Enhanced Reporting (CASPER) data network In March 2012, CMS launched a nursing facility quality initiative that included a goal to decrease the off-label use of antipsychotics by 15% by December 2012
Antipsychotic Drugs Identify who is being prescribed antipsychotics If the need still exist, suggest alternative courses of treatment if possible The use of antipsychotics in nursing facility residents should include: An appropriate indication for use A specific and documented goal of therapy Ongoing monitoring of the resident to evaluate effectiveness in achieving the therapy goal, and Development or presence of adverse effects from the medication Use of the medication only for the duration needed, and at the lowest effective dose
Step 3: Nurse Staffing Domain The CMS Staffing Study found a clear association between nurse staffing ratios and nursing home quality of care, identifying specific ratios of staff to residents below which residents are at substantially higher risk of quality problems The source data for the staffing measures is CMS form CMS-671 (Long Term Care Facility Application for Medicare and Medicaid) The resident census is based on the count of total residents from CMS form CMS-672 (Resident Census and Conditions of Residents) The specific fields that are used in the RN, LPN, and nurse aide hours calculations are: RN hours Includes registered nurses, RN director of nursing, and nurses with administrative duties LPN hours Includes licensed practical/licensed vocational nurses Nurse aide hours Includes certified nurse aides, aides in training and medication aides/technicians
Five-Star for MA and PD Plans
Program Expansion CMS is adding a 5-Star rating system to the Facility Compare, Dialysis Facility Compare, and Home Health Compare websites on Medicare.gov. Physician Compare has just started to include star ratings in certain situations for physician group practices Data Medicare.gov
Legislative History CMS originally developed star ratings in 2008 as a system to help consumers compare quality among competing Medicare Advantage plans The Affordable Care Act introduced a quality-based payment (QBP) structure for Medicare Advantage plans Medicare Advantage and MA-PD plans with a rating of four or more stars receive quality bonus payments (QBPs) based on quality ratings
Who is awarding star ratings? CMS does not give out star ratings to the pharmacy; they only evaluate the health plans Plans have the ability to see how pharmacies meet the five medication management measures While 5-Star compliance is primarily aimed at health plans, some measures, such as comprehensive medication review, high-risk drug education and point-of-service interventions for adherence are in the hands of the pharmacist These measures are solely based on claims billed from the pharmacy This gives the health plans a way to give pharmacies star ratings and evaluate which pharmacies are better at meeting the quality measures
Different Than in the SNF Context MA-PD Plans achieving star ratings of 4 ( above average ) or 5 ( excellent ) receive quality bonus payments, which can potentially represent millions of dollars in revenue The difference in payment between a 3-star and a 5-star plan averages $16 per member per month If a plan has 1 million members, that plan receives $192 million per year of additional revenue
Competitive Advantage Plan ratings can have a substantial impact on beneficiary enrollment Plans are required to use QBPs to provide extra benefits for enrollees (eg, eyeglasses, transportation to medical appointments) Plans that receive QBPs should be able to offer a larger set of benefits than their competitors, leading to greater enrollment The Medicare.gov website highlights 5-Star plans with a special icon to encourage beneficiary enrollment in these plans Conversely, plans that receive fewer than three stars for 3 or more consecutive years are designated by a warning symbol
Compensation Medicare Advantage and MA-PD plans with a rating of four or more stars receive quality bonus payments (QBPs) based on quality ratings Medicare Advantage plans began to receive bonus payments expected to amount to approximately $3.1 billion MA-PD Plans achieving star ratings of 4 ( above average ) or 5 ( excellent ) receive quality bonus payments, which can potentially represent millions of dollars in revenue The difference in payments between a 3-star and a 5-star plan averages $16 per member per month If a plan has 1 million members, that plan receives $192 million per year of additional revenue
Enrollment Members in a low rated plan can switch to a 5-Star rated plan at any time throughout the year, not just during open enrollment Beneficiaries enrolled in low ranked plans are notified and given the option to switch to higher quality plans Plans with fewer than three stars for the last 3 consecutive years will not be permitted to enroll beneficiaries through the Medicare website CMS star ratings have been shown to influence Medicare beneficiaries choice of a plan according to a study in JAMA
What s Needed: Share the Data The patient data available to pharmacists is limited largely to medications dispensed at their specific pharmacy The power of the pharmacist to contribute in a positive way would be much greater if pharmacists had access to both pharmacy and medical claims data and laboratory test results Without such access, pharmacists must draw inferences regarding patients diseases and health status a highly unreliable approach Assessing and sharing a patient's clinical status is the ultimate determinant of whether a specific drug is working as intended To provide quality-based outcomes, LTC Rxs need connectivity to the health information exchange and data exchange capabilities so that they can send information to other health care providers and receive information from providers
What s Needed: Technology Pharmacy management systems support medication adherence by offering such value-added services as: automated refill notifications, including text, e-mail, and voice messaging; prescription pick-up notifications; online refill requests and mobile technology; and ongoing measures of patient progress Pharmacists can consider investing in web-based systems that provide visibility on their CMS Star measure performance Inventory tracking, product procurement, and vendor management take considerable personnel time Systems for inventory management and dispensary workflow
What s Needed: Tools Medication use quality assessment Improve adherence Avoid waste and overfilling of medications Chronic disease management Transitional care intervention Behavioral change programs