Applying Public Comparative Effectiveness Research: How States Are Facing the Challenges

The comparative effectiveness research (CER) landscape has ballooned over the last decade (Figure 1). In 2005, the Agency for Healthcare Research and Quality (AHRQ) launched the Effective Health Care Program, in part, to produce, translate, and disseminate CER. The 2009 American Recovery and Reinvestment Act expanded government spending on CER to $1.1 billion over a 2-year period. Subsequently, the passage of the Affordable Care Act established the Patient-Centered Outcomes Research Institute (PCORI) and earmarked $6 billion for CER over the next 10 years.

A variety of different stakeholders turn to CER to meet their distinct needs. Patients and clinicians see CER as a way to inform their decision making with clinicians, and payers see CER as a resource for their coverage and reimbursement decisions.

Two primary providers of public CER to date have been AHRQ and the Drug Effectiveness Review Project (DERP). In 2011, more than 1300 CER reports were published (Figure 2). However, despite the volume and breadth of CER that exists and the number of potential users, no clear mechanism exists to ensure that the information is being translated and communicated in a way that actually meets stakeholders’ needs.

At the 2012 annual meeting of the Academy of Managed Care Pharmacy, Jenny Gaffney, senior manager, Avalere Health, discussed the challenges faced by state Medicaid programs in using public CER. Steven Pearson, MD, founder and president, Institute for Clinical and Economic Review (ICER) at Massachusetts General Hospital and Harvard Medical School, described a model that is enabling several New England states to overcome these barriers.

Last year Avalere and the Kaiser Family Foundation (KFF) initiated a study to look at how state Medicaid programs are using CER to determine their pharmacy benefits. “Now, more than ever,” said Gaffney, “Medicaid programs face a delicate balance in providing quality healthcare access to vulnerable individuals, while also being prudent with taxpayer dollars.” The report of their findings, The Role of Clinical and Cost Information in Medicaid Pharmacy Decisions: Experience in Seven States, was published in September 2011. Their study involved primary and secondary research on 7 state Medicaid programs (Florida, Minnesota, Nevada, Washington, Maryland, Louisiana, and Massachusetts) and 3 Medicaid managed care plans (Amerigroup, Molina, and United Healthcare).

What Type of Research Do States Need?

Pharmacy directors from both Medicaid fee-for-service and managed care plans prioritize clinical effectiveness in their preferred drug list decision making. All too often, however, evidence is not suffi cient for determining the equivalency or superiority of one drug versus another in terms of efficacy or safety.

In these cases, Medicaid programs default to comparisons of drug price to make their ultimate coverage decision. One state pharmacy director interviewed said, “We often have to line up the drugs and choose what drug to prefer based on the cost of the drug alone.”

Specialty pharmacy and therapeutic areas for which multiple treatment options exist are a priority of pharmacy directors from both the state Medicaid programs and managed care organizations (MCOs). These individuals also expressed a need for research in areas of high cost or prevalence. Specifically, they mentioned a need for CER on hepatitis C, multiple sclerosis, biologics, and atypical antipsychotics. “What is interesting,” Gaffney pointed out, “is that there are public CER reports in these areas, raising the question: Why aren’t they using this research?”

Challenges of Using Public CER

The Avalere/KFF report identifi ed challenges faced by states seeking to use public CER in their decision making: lag time between updates to public reports, lengthy format, and lack of cost information. Furthermore, the reviews are not customized to individual states’ needs and research priorities.

Pearson described some of the specific barriers faced by the New England Comparative Effectiveness Public Advisory Council (CEPAC), an independent evidence review body that serves to enhance the applicability of CER for its 6 constituent New England states and other stakeholders. States want to know more than just acquisition cost, he explained. They are looking to answer questions about budget impact, downstream effects, and cost offset (eg, reduced hospitalizations or doctor visits). The focus needs to go beyond next year’s budget to a demonstration of value. In other words, whether inclusion of something that is more costly in the short term will save money and provide clinical benefits in the long term.

Timing of report release in relation to the state drug review process is also a major issue. Medicare regional directors have to issue formal public notifications prior to drug coverage reviews and offer a public comment period as well. It is diffi cult to integrate public CER into this process because the report release dates are unpredictable.

What Alternatives to Public CER Exist?


Study investigators found 4 different models being employed by Medicaid programs (Figure 3).

In the first model, the Medicaid program partners with a local academic institution. For example, Massachusetts hires its local medical school to conduct clinical and cost reviews.

In the second model, the state relies on the clinical reviews of 1 or more public health technology assessment organizations. Only the state of Washington relies completely on public health technology assessment.

To make spending more predictable, other state Medicaid programs are turning over their pharmacy benefits to MCOs. Thirty-fi ve states currently contract with MCOs to provide services for almost half of their Medicaid beneficiaries. According to Gaffney, this is an increasing trend. Compared with the state Medicaid programs included in the study, the coverage decision– making processes of Amerigroup, Molina, and United Healthcare are less transparent—MCOs do not use public CER or stakeholder input during formulary development.

Finally, in the most popular model of the study, states contract with a pharmacy benefi ts manager (PBM). PBMs are able to cater specifically to the scope of each state’s preferred drug list (PDL) review. The drug review reports of one popular PBM address all of the aforementioned barriers imposed by public CER, which is one of the reasons the interviewed states have come to rely so heavily on them.

States see PBMs as a 1-stop shop for claims processing, supplemental rebate negotiations, and clinical and cost review preparation. The pharm acy directors from each of these states explained that their PBM provides a consolidated, up-to-date drug review that includes both clinical and cost information for the specifi c drug or class they are considering. And, best of all, the reviews conclude with specific PDL recommendations. Florida, Louisiana, Nevada, Maryland, and Minnesota rely on the same PBM for drug reviews.

The study identified 5 commonalities in the type of information states are seeking to inform their coverage decisions:

1. Backed by rigorous methodology.

2. Relevant to local needs and local contacts.

3. Timely and conclusive.

4. Produced in a transparent process.

5. Includes cost information.

Ultimately, Gaffney said, “It is going to be important to have a dialogue about how to reconcile the economic pressures states are facing with the sensitivity to cost and have a discussion around how we can explicitly include cost in these reports.”

Enhancing the Applicability of Federal CER

Steven Pearson talked about the process being employed by CEPAC to incorporate federal CER into state coverage and reimbursement decisions in New England. In describing CEPAC’s model, he broke it down into 3 components: structure, content, and process.

Structure


CEPAC comprises 19 members (minimum of 2 per state) from all 6 New England states. The council consists of clinicians and methodologists, as well as health policy experts. Two ex officio nonvoting members represent the payer perspective: 1 public and 1 private. Members of CEPAC are expected to be experienced with evidencebased medicine.

The day-to-day operations of CEPAC are overseen by ICER as part of an AHRQ-funded initiative to develop and test new ways to improve the usefulness of federal evidence reviews for patients, clinicians, and payers.

CEPAC seeks guidance from an advisory board comprising state Medicaid directors, medical society representatives, patient advocates, and regional private insurers. The board helps with topic selection and offers advisement on CEPAC products and processes. But more importantly, said Pearson, board members engage in rich dialogue about the use of evidence reviews in policy. They have learned from one another, not just about the evidence, but about what they are going to do with it and some of the barriers to actually using it.

Supplementary Content

At its core, the process relies on the executive summary of the AHRQ review itself. To make it more applicable to CEPAC’s needs, ICER provides supplementary content.

Prior to topic review, ICER improves the timeliness and relevance of the AHRQ review by conducting a follow-up search—using the search terms of the original report—to identify late-breaking studies published after the report’s fi nal search date. ICER also provides CEPAC with state-specifi c data; for example, prevalence, utilization, and practice patterns.

To address the need for cost information, ICER prepares a comparative value report. Different aspects of value are included: cost, budget impact analyses (shortand long-term), and cost-effectiveness analyses.

Process

After CEPAC receives the AHRQ review and supplementary content, a preliminary teleconference is held with regional clinical experts to discuss any questions they might have about the evidence.

CEPAC holds an average of 2 day-long public meetings each year during which select comparative effectiveness topics are reviewed. Toward the end of each public meeting, CEPAC interfaces with payers and clinical experts during a policy round table. “This has been very, very valuable for driving an alignment between health technology assessment and what is going on in the clinical community,” said Pearson.

CEPAC does not make formal coverage decisions. Rather, it mimics the model used by the FDA advisory committees in which recommendations are based on committee members’ up or down vote regarding the adequacy of the evidence.

The votes taken by the CEPAC advisory board include: “Is the evidence adequate to demonstrate that drug A is equivalent or superior to usual care or drug B for patients with condition x?” It is to some extent, admits Pearson, a judgment: “There is no perfect algorithm.” CEPAC members are also asked to vote on whether each care option is “high,” “reasonable,” or “low” value and to describe, for the public record, their reasoning for their vote (Table).

CEPAC sees this process as a way to engage not just payers but also the clinical community and the public in wrestling with these issues and in making votes about value.

A final report is prepared that includes policy recommendations regarding actions desired by societies, hospitals, or other stakeholders; comments on coverage options; and future research recommendations. The report is posted to the CEPAC website.

The ultimate goal of CEPAC is to synthesize the AHRQ review and the supplementary content into something that allows payers, practice guideline panels, patients, and others to grasp the real-world signifi cance of the evidence.


Revisiting Hypoglycemia in Patients With Diabetes


The primary goal of diabetes treatment is to achieve glycemic control through lifestyle change and the use of a variety of oral and injectable therapies, either alone or in combination. Intensive glucose-lowering therapy reduces costs and risk of long-term adverse outcomes, while increasing quality of life, but carries an increased risk for hypoglycemia.1-5

During a product theater sponsored by Novo Nordisk, Inc, at the Academy of Managed Care Pharmacy 2012 Annual Meeting, Kyle Peters, PharmD, RPh, BC-ADM, CDE, Siouxland Community Health Center, gave attendees an in-depth look at hypoglycemia and its significance. “As you try to intensify [diabetes] therapy and get patients to goal, you will have more lows just because of the nature [of the fact] that you are lowering blood sugars,” he stated.

In response to low blood sugar, the sympathetic nervous system initiates a “fight or flight” chain of events that shunts blood away from the extremities and toward the body’s core. The acute outcomes of a severe hypoglycemic event can be as severe as loss of consciousness, seizure, coma, or even death.

Hypoglycemia is a serious complication faced by patients with both type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM). A common misconception, according to Peters, is that hypoglycemia is only an issue for patients with T1DM because of the intensive insulin usage required with this group of patients. In a recent report, 3.5% of patients who were taking oral antidiabetes monotherapy for T2DM experienced hypoglycemia requiring medical intervention (n = 18,657).6 The vast majority of the approximately 26 million Americans with diabetes have type 2 (90%-95%), making the public health burden of hypoglycemia among this population significant.

The true impact of hypoglycemia, in terms of adverse outcomes and health cost expenditures, is difficult to assess because the condition is underreported by patients and underdiagnosed. Patients often have unrecognized hypoglycemia. In severe cases, Peters explained, patients may not sense a problem until their blood sugar is dangerously low, in the range of 30 to 40 mg/dL.

A 2003 study used continuous glucose monitoring over a 3-day period to record real-time blood sugar measurements of 70 patients being treated for diabetes. Study investigators found that 63% of T1DM patients (n = 40) and 47% of T2DM patients (n = 30) had unrecognized hypoglycemia.7 Seventy-four percent of all hypoglycemic episodes occurred at night.

Trial data on hypoglycemia is diffi cult to aggregate because no standardized defi nition of the condition exists. In fact, 3 major trials that looked at the efficacy of intensive glycemic control in patients with T2DM (ie, ACCORD, ADVANCE, and UKPD) each defi ned severe hypoglycemia differently.4,8,9

Adverse Outcomes

The body of evidence documenting the association between hypoglycemia and adverse events is strengthening.10 It is now known that hypoglycemia is associated with increased healthcare costs, fear, and anxiety, as well as increased risk of cardiovascular morbidity and death from any cause or a cardiovascular cause (Table 1).11,12 Additionally, reductions in quality of life and productivity have been linked to hypoglycemia.12

Fear of hypoglycemia among patients poses a psychological barrier to achieving tight glycemic control. Patients ranked their fear of severe hypoglycemia at the level of their concern about blindness and kidney disease.13 Peters, who has had diabetes since he was a child, remarked, “Once a patient has had a severe low, they are not going to be as aggressive…they are worried about waking up in the morning, and that is a real concern.

“The real moral of the story,” said Peters, “is if we can prevent hypoglycemia, we can prevent a lot of those poor outcomes.”

Hypoglycemia-Associated Healthcare Costs

Peters reviewed several studies that estimated the costs associated with hypoglycemia among diabetes patients. A recent retrospective cohort analysis of insurance claims data (Medstat MarketScan database, 2004-2008) assessed the costs of hypoglycemia among adults with T2DM who were taking at least 1 oral antidiabetes drug.6 Total hypoglycemiaassociated costs (inpatient, emergency department [ED], and outpatient) over the study period were $52,223,675.

“If you were thinking one day in your office, wondering how we could save money in diabetes care, well, if you eliminated a lot of the low blood sugar, you could probably take out a big chunk of that $52 million,” speculated Peters.

The mean cost of medical encounters (ie, inpatient, ED, outpatient) associated with hypoglycemia was up to 4 times higher than for other diabetes-related claims and was higher across several classes of encounters: inpatient hypoglycemia admissions, $17,564.25 versus $13,862.03 (P <.001); ED visits, $1386.80 versus $320.54 (P <.001); and outpatient episodes, $393.64 versus $112.22 (P <.001; Table 2).6

The authors concluded that potentially avoidable inpatient admissions for hypoglycemia accounted for nearly 60% of hypoglycemia-associated expenses for this population ($30,930,649 of $52,223,675).

A 2009 study documented 5 million hypoglycemiarelated ED visits by patients with diabetes between 1993 and 2005, equating to nearly 400,000 visits per year. Among those episodes, 25% resulted in admittance to the hospital.15

The 2011 diabetes mellitus clinical practice guidelines issued by the American Association of Clinical Endocrinologists includes the statement, “Patients may need to be hospitalized for observation if a sulfonylurea or a very large dose of insulin is the cause of the hypoglycemia because prolonged hypoglycemia can occur.”16

Compared with non–hypoglycemia-associated inpatient diabetes care, hypoglycemia in the inpatient setting was associated with higher total charges, longer lengths of stay, higher mortality, and higher odds of being discharged to a skilled nursing facility (mean total inpatient charge: $86,000 vs $54,000).17

Reducing Hypoglycemia

Treatment of the complications of diabetes, not the cost of medications, accounts for the majority of expense related to diabetes care.10 It is likely that decreasing the incidence of hypoglycemia will decrease adverse events and associated expenditures. Peters reviewed some of the ways hypoglycemia can be reduced.

Patient Education. Patients should be educated on the risk factors for hypoglycemia, including delayed, missed, or small meals; exercise (recommendations suggest 150 minutes per week of moderate-intensity exercise for patients with diabetes; hypoglycemia can occur during exercise or 2 to 3 hours post-exercise); diabetes medication (particularly older oral antidiabetes medications and older insulin prescribed as part of an aggressive protocol); drug or alcohol consumption; increased insulin sensitivity; and decreased insulin clearance. Peters explained the connection between insulin clearance and hypoglycemia: “Since insulin is cleared by the kidney, you see a lot of hypoglycemia in patients with poor renal function.”

Additional risk factors for severe hypoglycemia include advanced age and duration of treatment; intensive glycemic control (glycated hemoglobin [A1c] <6%)4; and hypoglycemic unawareness, which may be suspected in patients who have or have had nighttime hypoglycemia, antecedent hypoglycemia, or a history of severe hypoglycemia. Patients should also be made aware of the symptoms of hypoglycemia, which can be neurogenic or neuroglycopenic in nature. Trembling, palpitation, sweating, anxiety, hunger, tingling, dry mouth, and pupil dilation are commonly reported neurogenic symptoms.

Peters explained that it takes 15 to 30 minutes for patients to feel better after treating their hypoglycemia, and often they overtreat it and end up with a drastic spike in blood sugar. Hunger as a symptom of hypoglycemia is especially important because patients often overcompensate by eating too much.

Neuroglycopenic symptoms have more to do with behavior and function. They include cognitive impairment, difficulty concentrating or speaking, confusion, anger, headache, seizure, and loss of consciousness.

The message to patients, Peters concluded, should be, “If you don’t feel right, check and see where your glucose level is at.”

Practice Change. Doctors can help their patients avoid hypoglycemia by making appropriate therapy selections based on patient risk factors, intensity of glycemic control, and published recommendations and guidelines. A key consideration for prevention of hypoglycemia is to minimize fluctuations in blood glucose levels.

In a 2009 consensus statement, the American Association of Clinical Endocrinologists and American College of Endocrinology stressed that when making treatment selections for patients with diabetes, more weight should be placed on safety and efficacy than on cost of medications, since cost of medications represent only a small proportion of the overall cost of diabetes care.10

The consensus panel favors the use of GLP-1 agonists and DPP-4 inhibitors over sulfonylureas and glinides. Their rationale partially stems from the comparative safety profiles of these agents related to hypoglycemia risk.10

A recently completed comparative effectiveness review of oral diabetes medications (N = 107 studies) conducted by the Agency for Healthcare Research and Quality found that hypoglycemic episodes were 3 to 7 times more likely to occur in T2DM patients taking sulfonylureas versus those taking metformin, thiazolidinediones, or DPP-4 inhibitors. Combination therapies that included a sulfonylurea plus metformin were associated with excess risk of hypoglycemia risk compared with metformin plus a thiazolidinedione. The evidence supporting these conclusions was rated moderate to high by the report authors.18

In their 2012 T2DM guidelines, the American Diabetes Association and the European Association for the Study of Diabetes recommend metformin and lifestyle interventionsas first-line therapy for patients diagnosed with T2DM, unless metformin is contraindicated.19,20

If patients do not respond to the maximal tolerated dose of noninsulin therapy over 3 to 6 months, a second oral agent, GLP-1 receptor agonist, or insulin should be added.

Insulin, with or without additional agents, should be considered for newly diagnosed patients who are markedly symptomatic and/or have high blood sugar or A1c.

An update of the Beers criteria was published in April 2012. New to the criteria were 2 strong recommendations against the use of sliding scale insulin or glyburide in the elderly due to their association with risk of hypoglycemia. The sulfonylurea chlorpropamide remained on the list for the risk of hypoglycemia and syndrome of inappropriate antidiuretic hormone secretion it carries.21

Peters suggests analogue insulin for patients with T1DM or T2DM who require insulin to achieve blood glucose goals. Achieving an A1c level of less than 7 will reduce long-term complications of diabetes, including eye, kidney, and nerve disease. Effective control improves quality of life, decreases healthcare costs, and positively affects health outcomes.

When the wrong medicine is selected, or diabetes drugs are not used wisely, he cautioned, the result is more hypoglycemia, reduced medication adherence, reduced quality of life, less productivity, and increased healthcare costs.

Peters summed it up this way: “High blood sugar, over years, will lead to eye, kidney, and nerve disease. But, it only takes 1 hypoglycemic episode for you to lose co nsciousness… so hypoglycemia is more severe in the acute time frame.” Put that into context with the adverse outcomes and cost data and the gravity of hypoglycemia becomes clear.


Now Is the Time for Quality Improvement in the Pharmacy Setting


With new drivers emerging in the marketplace, including the financial implications of the Affordable Care Act, the importance of improving and maintaining the quality of healthcare is becoming increasingly apparent. Along these lines, mechanisms for measuring, monitoring, and reporting healthcare quality are drawing attention. The Pennsylvania Collaborative, led by CECity, created a model for improving and monitoring quality across health plans and pharmacies. The model is designed to serve as a foundation for future pharmacy risk-share and pay-for-performance programs.

The PA Collaborative includes the following organizations:

• CECity: provided the web-based, scalable technology platform and solution

• Highmark Blue Cross Blue Shield (Highmark): served as the source of prescription data for calculation of medication-use metrics

• Pharmacy Quality Alliance (PQA): provided the medication-use measures for performance assessment

• Rite Aid Corporation (Rite Aid): engaged the healthcare providers (ie, pharmacists and pharmacy managers) and provided executive-level organizational support to facilitate pharmacy involvement

• University of Pittsburgh School of Pharmacy (UPSOP): provided the intervention strategy for improvement and the detailed analysis for publication

Improving Medication Adherence: An Intervention Strategy

During a session of the 2012 Academy of Managed Care Pharmacy Annual Meeting, titled Measuring Up: What Is Around the Corner for Quality Improvement?, the PA Collaborative provided an overview of its quality improvement initiative, presented its most recent results, and discussed the expansion of the project to 3 states, Pennsylvania, Florida, and Alabama.

Demonstration phases of the project aimed to establish continuous information fl ow and methodologies while developing capabilities to measure improvements in professional practice and patient medication adherence. The group focused on the PQA adherence metrics for proportion of days covered (PDC). Annette Boyer, RPh, vice president, business development, CECity, explained, “The measures used focused on adherence for medications used in chronic disease. These were also the measures the pharmacists felt they could have an impact on.” During the demonstration, patients from 118 Rite Aid pharmacies in Western Pennsylvania (N ≈ 46,000) were universally screened to identify those at high or moderate risk of nonadherence to their prescription medication.

The screening instrument was a 3-to-4–question survey that utilized visual analogue scales and pictures to reduce literacy as a barrier to completion. In most pharmacies, screening was conducted by technicians. Pharmacists who were trained in motivational interviewing techniques followed up with at-risk patients. For their part, most pharmacists were very willing participants in the endeavor. “They were so eager to be able to have more patient involvement,” said Jan Pringle, PhD, director, Program Evaluation Unit, UPSOP.

David Nau, PhD, RPh, senior director, quality strategies, PQA, commented, “This is an effi cient model because it is not saying that you have to deliver the intervention to every patient out there, just to the ones who expressed concern and are likely to be nonadherent.” He estimated that 10% to 15% of screened patients expressed concern about their medication.

Monthly reports of performance were accessible to the pharmacies via a web-based platform developed by CECity. The platform provided store performance assessment based on data provided by Highmark and aggregated by CECity. Pharmacists’ performance was compared with goals established by Highmark, as well as with the performance of their peers.

To address gaps in performance, the platform dynamically linked just-in-time educational training, tools, and resources with performance metrics.

Impact on Adherence

The collaborative recruited UPSOP to oversee development and implementation of the intervention, evaluation of the project, and validation of the approach toward data aggregation and measurement.

Jan Pringle reported the results of their analyses of Highmark formulary claims data to assess improvements of the PQA PDC quality metrics.

Intervention stores (n = 118) experienced signifi cantly greater improvements in adherence rates compared with census-matched control group stores (n = 120) for most categories of medications. Of most importance, the changes in medication adherence in the intervention stores were sustainable and accumulated over time. Furthermore, their analyses found that successful stores visited and used the web-based platform more than stores with limited improvement.

For their analysis, the collaborative focused on 7 medication classes associated with major chronic diseases (including diabetes, cardiovascular diseases, and respiratory diseases). The results indicated a signifi cant increase in the percentage of Highmark patients who met a pre-established benchmark PQA PDC score for all the medication classes except dyslipidemia. The most dramatic improvements, approximately 10%, were seenwith patients taking beta-blockers and calcium channel blockers.

Putting this into perspective using their results from patients on ACEI/ARB therapy for hypertension, each month about 33 additional patients became adherent (n = 11,342; 118 stores). When multiplied over population and time, an improvement in medication adherence of this magnitude can add up to a signifi cant number of positively affected patients.

The Health Plan Perspective

Highmark’s participation in the project stems from its desire to balance the cost of healthcare with quality and access. The key, according to Maureen Bieltz, PharmD, clinical pharmacy specialist at Highmark, is to control and reduce healthcare spending while improving quality of services for plan members.

Incentive reimbursement programs (eg, pay for performance) have traditionally been used at the hospital and physician levels. Prior to this project, the utility of these programs at the pharmacy level had not been well explored. “I think we can all agree that pharmacists are the most easily accessible healthcare professional; this really gives us an opportunity to utilize them to improve quality of care,” Bieltz said.

The Center for Medicare & Medicaid Services (CMS) utilizes a Five-Star Quality Rating System to measure quality and performance of Medicare Advantage plans. One star indicates poor performance, 5 stars mean excellent performance. Plans receive an overall star rating, as well as categorical ratings. Now more than ever, health plans are looking for innovative ways to improve their star ratings.

Quality Bonus Payments (QBPs), a percentage increase in payment to Medicare Advantage plans above the standard rate, was introduced by the Affordable Care Act. Higher-rated plans will get higher payments. During the demonstration phase, planned to end in 2015, QBPs will be awarded on a sliding scale according to star ratings. Stand-alone part D plans will have marketing advantages related to star ratings, but not QBPs.

“In reality, the majority of health plans actually fall below the 4-star rating, so plans will be looking for ways to increase from now to 2015, to achieve that 4-star rating, to ensure that they are going to be reimbursed for their quality of care,” explained Bieltz. Because the PQA-endorsed metrics used by the PA Collaborative are also recognized by CMS, they emphasized that their approach can be used as a tool to improve plan star ratings.

Why Do Quality Bonus Payments Matter?


For 2012 and 2013, the QBP percentages for 4- and 5-star ratings will be 4% and 5%, respectively. In the year 2014, this percentage is planned to increase by 5% for plans with a star rating of 4 and above. The expected difference in payments for a 3-star plan is about 16% per member per month. This can have a signifi cant impact on the bottom line for large health plans.

For a Medicare Advantage plan with 1 million members, moving from a 3-star to a 5-star rating would boost revenue by approximately $200 million. PQA measures account for about 20% of the star rating for a Medicare Advantage plan that offers drug benefit. In 2015, when the ongoing demonstration period is scheduled to end, plans below 4 stars will not be eligible for QBPs and QBPs will change to ACA-specifi ed rates unless additional changes occur.

According to the collaborative, now is the time to start putting quality improvement measures into place to ensure 4-star ratings. Health plans need to fi nd ways to improve star ratings going forward.

Implications for Pharmacy

Bieltz explained that as CMS and employers increase their scrutiny of quality medication utilization, health plans are asking pharmacy benefit managers (PBMs) to measure and improve quality. PBMs will be looking to their retail networks and pharmaceutical companies to help boost adherence. Plans, pharmacies, and pharmaceutical companiescan work together to drive improvements in medication-use quality and improved medication adherence. She advocated that pharmacies and plans should share in the quality rewards (QBPs).

Future

Planned analyses will examine how well the intervention effect is sustained, if the accumulated impact results in further improvements, and whether the positive impact on adherence translates to decreased healthcare utilization (and perhaps medical costs). The potential impact of a pay-for-performance program for pharmacy will also be explored.

David Nau talked about the next stage of the project, a beta-phase of the Electronic Quality Improvement Platform for Plans and Pharmacies (EQuIPP; www.equipp .org). The group is getting ready for a May 2012 launch of EQuIPP in Alabama, Florida, and Pennsylvania. This phase will entail a multi-payer/multi-provider approach and the participation of major pharmacy chains (Target, Walmart, Rite Aid, CVS, Winn-Dixie, and others), independent pharmacies, and more than 10 health plans across the 3 states, including Highmark.

Enhanced reporting capabilities of the web-based platform will provide health plans with plan-level scores and benchmarks on selected PQA measures, as well as pharmacy-level reports for network pharmacies.

Pharmacies will receive their scores on PQA measures compared with peers and other state pharmacists, and by insurance mix. A pharmacy organization management report will also be offered, along with access to the online library of performance improvement resources. Nau commented, “We are trying to build this ability for community pharmacies to manage for quality and trying to help them view these as metrics that are just as important as cost to dispense and number of prescriptions sold… we are trying to make it easy for them to engage in quality management.”

While talking about the ongoing forward momentum of EQuIPP, Nau encouraged the participation of additional interested parties in the 3 target states. “It is not too late to get in on this phase if you want to get involved now.”