CMS Expands Use of PQA Measures

In October 2010, the Centers for Medicare & Medicaid Services (CMS) added another PQA-endorsed performance measure to the Medicare Part D performance evaluation system.  The Proportion of Days Covered (PDC) measure of medication adherence was added to the Part D Display Measure Set which is used for performance feedback to Part D plans.  At this time, it is not included in the Part D star ratings. 

The PDC measure includes separate rates for several classes of medications, including diabetes medications (biguanides, sulfonylureas, thiazolidinediones, and combined rate), angiotensin-converting enzyme inhibitor/angiotensin receptor blockers (ACEI/ARB), and medications for dyslipidemia.  These measures were initially developed and tested by PQA in collaboration with NCQA and Advanced Pharmacy Concepts.  In 2009, they were endorsed by the National Quality Forum (NQF).

The PDC measures join four other PQA-endorsed measures in the Part D performance evaluation system.  These measures are 1) high-risk medications in the elderly, 2) the use of ACEI/ARBs in patients with diabetes, 3) drug-drug interactions, and 4) excessive doses of oral diabetes medications.  PQA has agreed to provide CMS with semi-annual updates of the technical specifications and drug lists for these PQA-maintained measures. Back to Top

Hot Off the Press: Rapid Reviews of Key Quality Publications
by David Nau, PhD, RPh, CPHQ,Senior Director, Research & Performance Measurement, PQA

Three recent articles have highlighted the variation in drug utilization across the U.S.  Two studies by Zhang and colleagues revealed significant geographic variation in both Medicare drug spending and in the quality of medication use for Medicare beneficiaries.  To measure the quality of prescribing, the researchers used two measures from NCQA's HEDIS program, including "drugs to be avoided in the elderly” (aka, high-risk medications in the elderly) and "drug-disease interactions.”  They compared the rates on these measures across every Medicare hospital-referral region in the U.S. for Medicare beneficiaries enrolled in stand-alone Part D plans in 2007. The rates for the drugs to be avoided in the elderly ranged from 11.4% to 44.0% across the regions, while the rates for drug-disease interactions ranged from 9.5% to 30.6%. The highest rates for both measures were in southern states and sections of the Rocky Mountains, and the lowest rates were in the Great Lakes states and the northeast.

A study by Gellad and colleagues identified significant variation in drug spending across Veterans Administration Medical Centers (VAMC) for diabetes and lipid-lowering drugs.  This occurred despite the use of a National Formulary by VAMCs and nationally-standardized benefits for veterans.  The strongest predictor of the costs was the use of brand-name drugs.  The researchers found no correlation between drug spending and the quality of care as measured by HEDIS outcomes measures for diabetes and lipid control.  A key difference between VAMCs within the highest, and lowest, quartiles of spending was in their procedures for handling non-Formulary drug requests. 

Why These Studies are Relevant
 An important finding across these studies is that the quality of medication use was not significantly correlated with the amount of drug spending.  Thus, the quality of medication use needs to be independently assessed, and we should not presume that spending on drugs can be used as a proxy for the appropriateness or quality of medication use.  PQA continues to encourage public and private payers, as well as practitioners, to assess the safety and quality of medication use.  We also encourage collaboration between payers, physicians and pharmacists to measure and improve quality.   

Highlighted Articles: 
Zhang Y, Baicker K, Newhouse JP.  Geographic Variation in the Quality of Prescribing. N Engl J Med. (10.1056/NEJMp1010220); downloaded Nov 3, 2010.

Zhang Y, Baicker K, Newhouse JP.  Geographic Variation in Medicare Drug Spending. N Engl J Med. 2010;363:405-9.

Gellad WF, Good CB, Lowe JC, Donohue JM. Variation in Prescription Use and Spending for Lipid-lowering and Diabetes Medications in the Veterans Affairs Healthcare System.  Am J Manag Care. 2010;16:741-50. Back to Top

MARK YOUR CALENDAR: PQA Quality Forum Lecture Series Lines Up Two Timely Programs

December 9, 2010 at 1 PM EST
Partnering to Improve Adherence:
A Health Plan, Technology Company and Retail Chain Pharmacy Integrate Pharmacy Performance Reporting and
Quality Metric-Focused Interventions to Improve Medication Adherence for Health Plan Members

PQA is pleased to announce that the collaborating team of Highmark, Rite Aid, University of Pittsburgh and CECity will present an in-depth look at their PQA Phase II Demonstration Project. Focused on western Pennsylvania, the teams have built a scalable model for the delivery of performance reports to network pharmacies as well as for testing the effectiveness and return-on-investment of specific adherence interventions based on PQA quality measures. 

The presenters at this program will include Mark Conklin, PharmD, Clinical Pharmacy Specialist with Highmark, Annette Boyer, RPh, Vice President of CECity.com, Jesse McCullough, Field Clinical Services from the Rite Aid Corporation and Janice Pringle, PhD, principal investigator of the project from the University of Pittsburgh School Of Pharmacy.

Please RSVP to Karen Peterson, kpeterson@PQAalliance.org, by close of business on Tuesday, December 7, 2010 if you would like to join PQA for this lecture. The presentation and dial in number will be emailed out to all registered individuals the morning of December 8th.

January 20, 2011 at 1 PM EST
Specialty Pharmacy Issues and Trends:
Advancing Access, Affordability and Adherence

PQA is pleased to announce the speakers for January's PQA Quality Forum Lecture. Dr. Norrie Thomas and Richard Fry will share with you the results of an initiative organized and led by the Foundation for Managed Care Pharmacy (FMCP). The umbrella goal of the project is to conduct research and educational activities regarding access, affordability, and adherence to life-saving specialty medications that will help people live healthier, happier lives. To achieve this goal their work is devoted to (1) gaining consensus on definitions, terminology and language in specialty pharmacy, assessing current benefit design and care delivery methods, (2) examining service-level specifics, incentives and fees associated with specialty pharmacy products and offerings and (3) assembling information that enhances decision-makers understanding and interpretation of the specialty medication pipeline.

Join us as they share results from their Phase I of this important work, and their plans for Phase II research.

Dr. Norrie Thomas is the President of the Manchester Square Group and currently serves as the Interim Executive Director for the Foundation of Managed Care Pharmacy. She will be joined by Richard Fry, a consultant for the Foundation for Managed Care Pharmacy.

Please RSVP to Karen Peterson, kpeterson@PQAalliance.org, by close of business on Tuesday, January 18, 2011 if you would like to join PQA for this lecture.  The presentation and dial in number will be emailed out to all registered individuals the morning of January 19th. Back to Top

PQA Submits Comments to HHS: Adherence and Care Coordination Are Top Goals

In the early fall, the US Department of Heath and Human Services (HHS) released its draft of the National Health Care Quality Strategy and Plan and invited comments on their proposed principles for the National Quality Strategy as well as the proposed framework. PQA convened a small group of its members to draft comments for HHS on the document.  The document asked organizations to comment on a series of questions and PQA made two specific recommendations for 5-year aspirational goals that should be put in place.

The first of the PQA goals is:
"By 2015, at least 75% of patients taking chronic medications will be highly adherent to their medication regimen.”
This has been coined the "75 in 5” goal.

Similar to IHI's 100,000 Lives Campaign, PQA proposes that there would be a public-private partnership established that would set a target goal of 75% of patients maintaining high levels of adherence with medications used to treat chronic conditions. This goal could be tracked using adherence measures jointly developed by PQA and NCQA, and endorsed by the National Quality Forum (NQF). The measures evaluate the proportion of days covered (PDC) for patients who use medications for diabetes and /or cardiovascular diseases.  CMS has begun to monitor the PDC for Medicare beneficiaries who are enrolled in Medicare Part D and will provide feedback to Part D plans to engage them in improvement efforts related to adherence.  Additional feedback to physicians and pharmacists may also help engage all providers and plans in a coordinated effort to support patients in appropriate use of chronic medications. Electronic health information technology may further assist in this effort to share information across providers.

The second PQA aspirational goal is:
"By 2015, every patient discharged from a hospital who is at high risk for readmission will receive a comprehensive medication review by a pharmacist.”
Care coordination is one of the 6 national healthcare priorities identified by the National Priorities Partnership. There is growing evidence that better care coordination can lead to a measureable reduction in hospital readmissions and better patient outcomes. PQA commented that since many readmissions to a hospital are due to medication-related problems, each patient being discharged from the hospital should receive a comprehensive medication review by a pharmacist or other healthcare provider. This review process should include reconciliation of the patient's medications prior to their hospitalization with the list of discharge medications. Any and all medication changes and other critical medication information should be clearly communicated to patients, family members, and the patient's primary healthcare provider or other organization of care (i.e., assisted living facility, nursing home, etc.) and medications should be reconfirmed each time a patient experiences a transition in care. 

To achieve this goal, HHS should continue to promote the implementation of electronic health information technology to facilitate communications between hospitals, primary care physicians and pharmacies. We recommend that HHS and/or CMS together along with the private sector establish and support demonstration projects that can work to implement this model within the healthcare delivery system. PQA has created the model framework for medication reconciliation projects that delineate the steps, the partners, and the process necessary to achieve appropriate medication reconciliation as an integral part of the care coordination process.
PQA stands ready to assist HHS and AHRQ in the implementation of any elements of the National Health Care Quality Strategy and Plan that can improve the safe and appropriate use of medications.  Over the past 4-5 years, there has been a proliferation of sector-specific quality alliances, including the Ambulatory Quality Alliance, the Long-Term Care Quality Alliance, the Hospital Quality Alliance, the Nursing Quality Alliance, and the Dental Quality Alliance...to name a few. PQA recommended HHS consider convening the leadership of these various alliances to seek their direct support as implementers of the plan. As an alternative, HHS may want to seek commitments from the various Alliances to develop well-defined action plans for those specific goals that are included in the report to Congress.

A final recommendation from PQA was to include community pharmacies and pharmacists in initiatives involving the implementation of electronic health information technology.  This involvement needs to go beyond enabling pharmacies to receive electronic prescriptions. Pharmacists also need to be able to ensure appropriate care by sharing information with primary care physicians and hospitals regarding medication use by patients and to facilitate medication reconciliation efforts as patients transition from one care setting to another. The newly formed Pharmacy e-HIT Collaborative (http://www.pharmacye-hit.org/) will be critical in facilitating these efforts. Back to Top

New England Journal of Medicine Article Heightens Issues of Four-Dollar Generics: Affordability and Accessibility on the Rise, However May Impair Quality Assurance Efforts

In a recent article in the New England Journal of Medicine (November 11, 2010 issue) Niteeesh K. Choudhry, MD, PhD, and William Shrank, MD, MSHS, discussed the growth of low-cost generic drug programs offered by many leading drug chains, and the impact of these programs on the ability of health plans to measure quality.

These low cost generic drug programs, often referred to as "$4 generic programs,” were introduced by Wal-Mart in 2006 and have rapidly spread throughout the country. The programs allow patients to purchase selected generic medications for $4 per month or perhaps even $10 for a 3-month supply. The prices offered by these programs are often lower than the copayment for generic drugs in commercial insurance programs. Therefore, some patients opt to have the prescription filled outside of their prescription benefits program to save money. 

The good news mentioned in the article is the positive impact that these programs are having on the affordability of essential medications for patients with chronic conditions, particularly with respect to patients who do not have health insurance. However, a consequence of patients filling their prescriptions outside of their prescription drug program is the loss of information about the patient's medication-use patterns.  If no prescription claim is submitted to the insurer, then efforts to monitor and improve the quality of medication utilization are hampered.

The article cites the role of PQA in developing quality metrics that use pharmacy claims, including the PQA measures of medication adherence, and how these data are being used to support interventions to improve adherence with chronic medications.  What is unclear is the extent to which the $4 generic programs may be affecting the accuracy of medication adherence estimates generated from drug claims. Some health plans have tried to minimize the likelihood of patients getting prescriptions filled outside of the plan by either setting their copayments for generic drugs at retail stores to $4, creating incentives to use the plan's mail-service pharmacy, or by creating requirements for the pharmacy to submit all transactions for their patients (including cash transactions).

The potential fix: the authors explore two potential solutions:

1. Ensure that pharmacists submit to pharmacy benefit managers all claims for beneficiaries, including those for drugs that are paid for in cash. This may require incentives to the pharmacies/pharmacists to submit this documentation but with an incentive structure that does not violate kickback regulations.
2. New information systems can be developed that can integrate pharmacy data with other rich data sources. Electronic health records, and electronic prescribing systems can play a role in health system monitoring and quality assurance, by developing new strategies and applications for harnessing data on prescriptions issued, instead of prescriptions filled.

Bottom Line: Administrative data are critical to the evaluation and management of the quality of health systems. Low cost generic programs have a role to play in improving access to medications. Together we must find a way to not diminish our ability to measure and improve the quality of U.S. healthcare. Back to Top

Nayer and Sweet Share Vision around Outcomes-Based Contracting and Value-based Design: PQA Quality Lecture Series Review

"The importance of aligning incentives cannot be overstated: the value-based design comes of age by focusing the behavior change across all the stakeholders, producing healthier people, healthier organizations, and healthier communities.” This was the core message from Cindy Nayer, President and Founder at Center for Health Value Innovation. Nayer was joined by Brian Sweet and the pair spoke to a "capacity” virtual crowd during the October 28th, 2010 PQA Quality Lecture Series.

The presentation provided an overview on the evidence of improved health and economic outcomes through value-based designs, the framework that emerges when aligned incentives focus on the ultimate end-game: individuals who get healthier and organizations that develop predictable economic trends. Nayer envisions more rapid adoption of outcomes-based contracting (OBC) than earlier value-based benefit design models "because the pathway is now clear for a complete shift to accountability, the natural extension of shared-risk and shared-reward.” Nayer continues, "If the dividends of reduced health risks and costs are shared across the stakeholders, then everyone wins. The goal is to find that harmony, strengthen engagement, value and accountability, and provide meaningful improvement in quality and effective care.”

Brian Sweet, B.S. Pharm., M.B.A. is Chief Pharmacy Officer at WellPoint, Inc., a 33 million member Health Benefits Company. Brian is responsible for overseeing the company's Clinical Pharmacy Services including clinical product development and strategic partnerships with pharmacy-based organizations. Sweet echoed that there is a natural progression from value-based designs (VBD) that reduce waste and increase stakeholder engagement to outcomes-based contracting that aligns incentives and creates an accountable care environment.

The value-based design (VBD) is a quality improvement tool that emphasizes data, design, deliver and dividends where data is used to design incentives for improving care delivery and, when these components and processes are aligned, dividends are reflected in improved quality and health, system performance and cost trend reduction.  Some key care performance targets with specific data indicators ("levers”) include prevention/wellness, chronic care and care delivery.  One example of an outcomes-based contracting arrangement would be for a drug manufacturer to back the performance outcomes to demonstrate the value of its drug(s). The process would require agreement between the care provider organization and the manufacturers on identifying the most important clinical outcomes measure(s) to track for a particular agent and the duration of treatment to determine benefit. This relationship would offset the uncertainty for the care system/providers regarding the therapeutic value of the drug or the external validity of the supporting clinical trial data. One example shared in the presentation was, in 2007, Johnson & Johnson made a deal in the U.K. that guaranteed rebates on its cancer drug Velcade. If patients didn't show enough improvement then the company would reimburse the health system for the cost of that patient's drug. Another example involved a pharmacist coaching/MTM program for diabetic and hypertensive patients supported by an employer organization that waived copayments for diabetes, hypertension, and cholesterol medications for its employees as long as they maintained participation in the program.

For more information on outcomes-based contracting or value-based design, visit the Center for Health Value Innovation. Back to Top

New Pharmacy e-HIT Collaborative Seeks to Secure Position of Pharmacy Clinical Services

The Pharmacy e-Health Information Technology Collaborative (Collaborative) is an organization focused on influencing the structure, development, and implementation of the U.S. health information technology (HIT) infrastructure with the goal of ensuring the profession's HIT needs are addressed and integrated into the national HIT framework. The Collaborative is an organization founded by nine unified pharmacist organizations to ensure that pharmacist-provided clinical services are represented in the electronic health record (EHR). [See website link at http://www.pharmacye-hit.org/about_us] The founding organizations of the Collaborative represent pharmacists working in all patient care settings within the health care system, in addition to many other facets of pharmacy including pharmacy education and pharmacy education accreditation.

The Collaborative will:

• Facilitate the provision and enhance the quality of patient care services provided by pharmacists.
• Address the profession's HIT needs and functionality to provide, document and bill for pharmacist-provided patient care services in all care settings.
• Influence HIT policy through unified, consistent communications to the Office of the National Coordinator for Health Information Technology (ONC) and other HIT organizations about pharmacist-provided patient care services and pharmacists' contributions to the ONC defined meaningful use (MU) of EHR.
• Ensure that resources, technical standards, and provider knowledge are aligned with the nation's growing need for pharmacists' services.

The Collaborative has developed a number of key objectives, including defining the minimum data set and functional Pharmacist/Pharmacy Provider electronic health record (PP-EHR) capabilities.  The group plans to facilitate actions that entrench the PP-EHR in the national HIT initiatives in order to support the delivery, documentation, and billing of services provided by pharmacists in all patient care settings through the meaningful use of HIT. The Collaborative plans to form a structured group consisting of organizations and individuals interested in creating a consensus-based "Roadmap” document that will ensure that medication-related technology is meaningfully used in an efficient and effective manner that enables pharmacists to affect improved medication use.  A critical goal of these efforts will be to guarantee that the PP-EHR becomes a model through the technology standards development organizational process; that criteria for certification are defined; and that the PP-EHR is certified and adopted by the pharmacy sector.

The Collaborative is an ambitious effort and the timing of these efforts could not be more optimal. Ideally the group will service as a unified voice of pharmacy representation on key HIT‐related committees and workgroups to influence the recognition of pharmacists and the services they provide.  As pharmacists become more engaged with HIT policymakers, the influence of other health professionals' defining of HIT platforms that impact pharmacy HIT will be lessened.  More information on the Collaborative can be found at  www.pharmacye-HIT.org. Back to Top

NCQA Releases Draft Standards for ACOs

In October 2010, the National Committee for Quality Assurance (NCQA), which accredits managed care organizations, released a set of draft standards for accountable care organizations (ACO) for public comment. NCQA currently develops quality measures for health plans, including Medicare Advantage plans, and recognizes organizations as patient-centered medical homes (PCMH). The draft criteria were developed by an NCQA task force to assess "core capabilities" for ACO success. " Criteria should provide a blueprint for ACO development and assess core capabilities that improve the likelihood of success," stated the chair, Robert J. Margolis, MD, of HealthCare Partners Medical Group.

The recently approved Patient Protection and Affordable Care Act (HR 3590) seeks to improve the health care delivery system through incentives to enhance quality, improving beneficiary outcomes and increasing the value of care. ACOs are provider-based organizations that take responsibility for meeting the health care needs of a defined population with the goal of simultaneously improving health, improving patient experience and reducing per capita costs. The PPACA makes provisions for ACOs to share in the cost savings they achieve for public purchasers; many private payers are expected to follow suit. Providers in several states are already working to establish ACOs. How they organize themselves as accountable entities will vary based on region, population needs or local environmental factors. NCQA is developing criteria that are within reach of the range of ACO configurations (e.g. "virtual” ACOs created by independent practice associations, multispecialty practices, integrated delivery systems, etc.) and that provide consumers, policy makers and other stakeholders greater confidence in this emerging innovation.

The NCQA standards included 13 key target issues. Some of the key inclusions that PQA members and pharmacists should take note of are:

• Health services contracting. The organization arranges for pertinent healthcare services and determines payment arrangements and contracting. At least a portion of practitioners' compensation is based on the performance of the ACO as a whole, using clinical quality, cost and satisfaction indicators, and there is a process to monitor utilization patterns for inappropriate restrictions on care that may arise unintentionally from existing payment arrangements.
• Population health management. Accurate identification of care needs and the provision of population health management programs enable organizations to provide quality patient-centric care. There is a documented process to identify patients who are eligible for wellness or preventive care services, chronic disease management services and complex case management.
• Practice support. The organization encourages practice sites to engage in registry data collection, electronic prescribing and patient self-management.
• Information exchange for care coordination and transitions. The organization has a coordinated system of care between multiple providers to offer integrated, timely and effective care.
• Performance reporting. The organization measures and reports clinical quality of care, patient experience and resource stewardship. At least once a year, the ACO monitors at least three preventive care measures, at least five chronic care clinical measures, at least one acute-care clinical measure and at least two measures of expenditures, resource use or appropriateness.
• Quality improvement. At least annually, the organization measures and analyzes the results of performance measurement activities and takes action to improve effectiveness in key areas.
  

One key question offered up by the NCQA taskforce was how might currently available measures such as HEDIS, Meaningful Use, and California IHA be used?

There is vigorous debate in policy circles today about how to qualify organizations to act as ACOs and how to evaluate their performance. Based on years of experience with measurement and evaluation, NCQA believes that it should begin with structure and process measures that tell us that an ACO has the infrastructure necessary to function as an accountable entity and achieve the triple aims. "While performance measurement is critical to evaluate ACO success, it will take some time before organizations can be judged on the outcomes they achieve” said Dr.Margolis. Back to Top