Pharmacy Quality Assurance Continues To Change and Expand
Roger S. Klotz, R.Ph., BCNSP, FASCP, FACA, FCPhA, CDM
Care Partners Consulting Pharmacist, LLC
Hospital and home care professionals are very familiar with Quality Improvement Organizations in the form of the JCAHO and ACHC who have developed standards and then survey the providers to assure that the meet the standards in order to receive full accreditation status. Bothe the ACHC and the JCAHO have attained “Deemed Status” with CMS. Added to this list of quality measures are the USP/NF Chapter <797> standards which are now part of the standards for the accrediting organizations. Chapter <797> revised standards for 2006 have been under review and should be released this year or early next year when the review is completed.
All of the above standards have changed the way hospitals and home infusion providers operate and care for patients. Pharmacy in particular has to meet standards regarding not only sterile compounding and the compounding environment, but also has been given additional responsibilities and now are accountable for assuring that sterile products are not only compounded proper, but also that professionals and patients are properly trained regarding the proper handling, storage, administration, and monitoring for adverse reactions for all sterile medications. The accrediting bodies require that the pharmacist correlate the patient’s diagnosis to the drug therapy being administered in order to avoid inappropriate use, unwanted drug-diagnosis interactions, and/or drug induced disease. This requirement is part of the accreditation organizations survey as a result of the requirements of CMS. Obtaining “Deemed Status” also changed the way the accreditation organizations must operate. Pharmacists are now also responsible to not only document drug allergies, but to indicate the symptoms associated with those drug allergies. This is now required to assure that the patient indicated allergy is actually an allergy and not an adverse reaction. The difference will have a significant impact on the options available in the treatment of their disease. Accreditation surveyors are now required to review the patient’s record in order to collect data to assure that these new standards are fully implemented by the providers. Accreditation surveyors like the professionals they survey are continually required to participate in training programs to bring them up to date with the every changing quality improvement standards.
Pharmacists in all areas of pharmacy have been and will be greatly impacted by the additional changes resulting from the passage of the “Medicare Modernization Act” of 2003 which include the creation of Medicare Part D benefit. The full impact of Part D implementation by CMS will be felt over the next few years and will further create quality improvement changes. Pharmacist and their professional organizations are very excited about the inclusion of the “Medication Therapy Management” benefit into the Part D benefit. This is good news to the profession in general that the pharmacist is now being considered a Medicare Provider, but with respect and professional acceptance will also come responsibilities and accountability. We must expect that patients/consumers and the payers, especially CMS, will want to know the quality services/care being provided and which pharmacist providers are the most effective and quality providers. One would expect that this would result in the development of quality standards and a program to measure each of these quality standards and whether the pharmacist provider is addressing and meeting these standards as they are developed. CMS requires that hospitals, nursing home care providers, and home infusion providers be accredited as a means of addressing the quality care issues. So it is not surprising that Mark McCullan M.D., head of the CMS, has created and is chairing the Pharmacy Quality Alliance (PQA) steering committee.
The PQA committee is made up of representatives from the pharmacy professional organizations, pharmaceutical industry, payer organizations, consumer groups, and the CMS. The charge is, through a pharmacy alliance, to develop quality measures and a reporting system. There are two work groups that have been created as part of the PQA. The Quality Metrics Work Group has been assigned the task of developing the Quality Metrics (standards) that can be used to measure the quality of patient care provided to Medicare recipients. The Report Work Group is assigned the task of developing a report process that will collect the data, analyze the data collected, and develop methods for report back to the pharmacy providers. The quality standards are assumed to be applied and measure in all areas of pharmacy practice including community pharmacy practice. The PQA committee will thus affect all pharmacy providers who will participate in provision of patient care services. The Work Groups have already begun to meet on a regular basis and members of each Work Group can participate in both groups and is a member of the PQA committee. A meeting of the full committee will be held November 20th 2006 in Washington DC. Prior to this each of the Work Groups will hold telephonic meetings approximately twice monthly. It appears that the PQA is moving aggressively ahead in developing, implementing, and reporting the results of the new quality standards.
- The PQA does recognize that reporting information to pharmacist providers on their respective performance is critical for improving quality and patient safety as well as promoting accountability. Some of the key points that the Reporting Work Group is considering the following:
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- Reports should focus on the areas that have the greatest opportunities to improve the quality by making care safe, timely, effective, efficient, equitable and patient centered.
- Reports should produce actionable information that allows for improvement in at least one of three areas which include processes, outcomes, and/or structure.
- Reports should include overall composite assessments of individual pharmacist or pharmacy practice performance as well as assessment of the individual measures used for the overall composite assessment.
- Reports should consider the practice setting and acknowledge that measures, processes, outcomes, and structure may need to be tailored as appropriate
It is obvious that there will be major changes in the way data is collected, distributed, and assessed. The Quality Metrics Work Group will deal with the development of the outcomes to be measured and the information needed to address the quality metrics to allow for efficient and consistent data collection.
Added to the process for change is the Institute of Medicine’s report regarding “Redesigning the Health Insurance” will probably add to the focus on changing the healthcare system and documenting the providers who will provide quality care. Quality care in the long run reduces total healthcare costs, which the reason Congress is added MTM requirement to Part D benefit. You can get a copy of the IOM report at www.iom.edu .
The fact that Dr. McCullan is directly involved in the PQA committee is a further indication of the placed by CMS and the Congress of developing pharmacy provider quality standards. This also speaks to the fact that the developed quality standards will be applied to pharmacy practice reimbursement aggressively. This will be a challenge to the profession, but on the other hand it shows that the pharmacy profession has gained the respect of the consumer, medicine, and the government. With respect comes responsibility so it is not surprising that society is saying that we want to be assured that we are fully utilizing the professional skills/knowledge of the pharmacist and we want to reward those pharmacists that will commit to providing excellence in patient care. The PQA committee and CMS will have a tremendous impact on all areas of pharmacy practice so we will continue to update you in this news letter as the PQA committee develops the quality standards and ultimately in the progress toward full implementation. The impact will probably not only be to the pharmacists caring for Medicare/Medicaid patients, but ultimately to the pharmacists providing care to all patients. Ultimately the patient and their physician, I assume, will be able to go to the CMS web site to evaluate their pharmacist provider.
You may also want to go to the PQA web site (www.pqaalliance.org) periodically to see the progress of the committee and the development of the new quality standards/measures. At this time all pharmacists should have obtained their National Provider Identification (NPI) number as an individual practitioner. If you haven’t registered for your NPI number you can go the web site (https://nppes.cms.hhs.gov) to register. It is critical that all pharmacists and their organizations keep up to date on what is happening with the PQA committee as well as the progress of the implementation of the NPI number system implementation. The traditional reimbursement numbers (i.e. UPIN, NABP) numbers will be replaced in 2007 (full implementation by May 15th 2007) by the NPI number for all providers (i.e. physicians, pharmacists, pharmacies). NCPDP has recently joined the PQA committee to participate in the reporting program development. NCPDP already has some of the reporting capabilities for reporting advanced patient information in their Telecommunication Standard Version 5.1 such as creating fields for communicating clinical laboratory values to health plans for each patient. Things are moving forward rapidly so please pay attention so you can participate and you won’t be surprised when the final standards are implemented. Please feel free to submit any questions you have to this newsletter and we will respond in the following issues.