Centers For Medicare Medicaid Services Research Articles

Moving toward Equitable Care for Sleep Apnea in the United States: Positive Airway Pressure Adherence Thresholds: An Official American Thoracic Society Policy Statement.

Background: Positive airway pressure (PAP) is a highly effective treatment for obstructive sleep apnea (OSA), but adherence limits its efficacy. In addition, coverage of PAP by CMS (Centers for Medicare & Medicaid Services) and other insurers in the United States depends on adherence. This leaves many beneficiaries without PAP, disproportionally impacting non-white and low socioeconomic position patients with OSA and exacerbating sleep health disparities. Methods: An inter-professional, multidisciplinary, international committee with various stakeholders was formed. Three working groups (the historical policy origins, impact of current policy, and international PAP coverage models) met and performed literature reviews and discussions. Using surveys and an iterative discussion-based consensus process, the policy statement recommendations were created. Results: In this position paper, we advocate for policy change to CMS PAP coverage requirements to reduce inequities and align with patient-centered goals. We specifically call for eradicating repeat polysomnography, eliminating the 4-hour rule, and focusing on patient-oriented outcomes such as improved sleepiness and sleep quality. Conclusions: Modifications to the current policies for PAP insurance coverage could improve health disparities.

Conflicts of Interest Among Authors of Systematic Reviews and Meta-analyses Investigating Interventions for Melanoma: Cross-sectional Literature Study.

Previous studies have highlighted the potential influence that industry relationships may have on the outcomes of medical research. We aimed to determine the prevalence of author conflicts of interest (COIs) in systematic reviews focusing on melanoma interventions, as well as to determine whether the presence of these COIs were associated with an increased likelihood of reporting favorable results and conclusions. This cross-sectional study included systematic reviews with or without meta-analyses focusing on interventions for melanoma. We searched MEDLINE and Embase for eligible systematic reviews published between September 1, 2016, and June 2, 2020. COI disclosures were cross-referenced with information from the CMS (Centers for Medicare & Medicaid Services) Open Payments database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office, and previously published COI disclosure statements. Results were quantified using descriptive statistics, and relationships were evaluated by Fisher exact tests. Of the 23 systematic reviews included in our sample, 12 (52%) had at least one author with a COI. Of these 12 reviews, 7 (58%) reported narrative results favoring the treatment group and 9 (75%) reported conclusions favoring the treatment group. Of the 11 systematic reviews without a conflicted author, 4 (36%) reported results favoring the treatment group and 5 (45%) reported conclusions favoring the treatment group. We found no significant association between the presence of author COIs and the favorability of results (P=.53) or conclusions (P=.15). Author COIs did not appear to influence the outcomes of systematic reviews regarding melanoma interventions. Clinicians and other readers of dermatology literature should be cognizant of the influence that industry may have on the nature of reported outcomes, including those from systematic reviews and meta-analyses.

Current State of Shared Decision-Making for CT Lung Cancer Screening and Improvement Strategies.

Introduction:Lung cancer remains the leading cause of oncologic mortality in the United States. Computed tomography (CT) screening has begun to combat this prevalent health problem. Prior to enrollment, a shared decision-making conversation is required to ensure a patient preference decision. This is the first and only imaging study to hold this requirement and compliance has been suspected to be low, but there is limited literature proving this.Methods:At a single academic institution, 30 patients who declined and 38 patients who enrolled in CT lung cancer screening were interviewed about their shared decision-making provider conversation. All referring providers were surveyed regarding their methods of shared decision-making for CT lung cancer screening. Clinical notes were evaluated 9 months prior to 2 interventions and 6 months following the first intervention to improve clinical documentation.Results:85% to 89% of the interviewed patients could not recall a decision aid used during the shared decision-making conversation. Zero percent of clinical notes met the Centers for Medicare/Medicaid Services (CMS) encounter requirements for shared decision-making despite interventions to improve knowledge and ease accessibility to decision aids and documentation templates.Discussion:Lack of compliance with CMS requirements has a low patient decision satisfaction. This also places the institution at risk for financial repercussions of reimbursement which may jeopardize the longevity of screening programs. Development of strategies to improve the patient experience and provider facilitation are nascent and require a dedicated leadership team with carefully constructed electronic health record support.

Accurate Identification of Infection Source in Burn Trauma Patients With Central Line Infection to Determine Appropriate Treatment Option As Well As Proper Public Reporting.

With the advent of the Patient Safety Movement in the late 1990s and the CMS (Centers for Medicare & Medicaid Services) nonreimbursement program for never events, there has been much focus on the prevention and accurate identification of health care-associated infections such as central line-associated bloodstream infections (CLABSIs). There has certainly been a national effort to decrease the occurrence of these infections. With the implementation of patient safety initiatives such as the central line prevention bundle, there has been a considerable reduction in the number of CLABSIs except for patients with burn trauma. Because of the compromised nature of these patients, the number of CLABSIs has not decreased similarly to other types of patients. In addition, these patients may have a secondary infection that was not accurately or timely identified. With CLABSIs, proper identification of primary and secondary infections is very important, particularly when identifying treatment options and ensuring accurate public reporting of health care-associated infection information.

Is More Really Better? An Examination of Services and Payment Patterns among Urologists from the Centers for Medicare & Medicaid Services

IntroductionWe examined provider and regional variation in services provided and payments made to urologists by CMS (Centers for Medicare & Medicaid Services) by linking payments to individual beneficiaries and examining the proportion of submitted charges resulting in payments. MethodsWe analyzed Medicare Part B Provider Utilization and Payment Data released by CMS for 2012, the last year of the purely fee-for-service reimbursement model. For each provider we determined the ratio of number of services provided to individual beneficiaries as well as the ratio of total submitted charges-to-total Medicare payments. Each provider was stratified into deciles of total Medicare payments and the mean per decile of total Medicare payment was calculated. Finally, to elucidate the potential association between the ratio of services-to-beneficiaries, we conducted multivariate linear regressions. ResultsThe 20th, 40th, 60th and 80th percentiles for the ratio of number of services per individual beneficiary ratios to total Medicare Part B payments are 2.8, 4.0, 5.2 and 7.4, respectively. Urologists with greater payments received provided more services to individual beneficiaries. Submitted charges exceeded payments by 3:1. Finally, female providers had lower ratios (p <0.01) and there was significant regional variation in the ratio of services per unique beneficiary (p <0.001 for each of the 10 Standard Federal Regions). ConclusionsWe found significant variation in services and payment in CMS. Reimbursement models replacing fee-for-service should be tailored to ensure appropriate health care resource utilization.

Making the Case for Nurse Practitioners in the Emergency Department: A Clinical Case Study.

Emergency departments (EDs) across the country are inundated with patients and they struggle to provide the expected standard of care while meeting set benchmarks. A shortage of emergency medicine physicians further complicates the situation, and many facilities are utilizing nurse practitioners to bridge the gap. A clinical case study was conducted at Touro Infirmary, a large urban hospital in New Orleans, LA, to provide an in-depth look at the implementation and positive outcomes of nurse practitioners in one ED. The model used at this facility included a nurse practitioner in the "fast track" area of the ED as well as a nurse practitioner in triage. Overall, the door-to-provider time decreased from 59.25 min in 2012 to 32.08 min in 2013. The bed-to-provider time decreased by an average of 9.17 min, with a 22.92-min average seen in 2012 and a 13.75-min average seen in 2013. An average decrease of 18.3 min was seen in the overall length of stay from 2012 to 2013. The percentage of left without treatment dropped by 3.77%, from 5.07% in 2012 to 1.3% in 2013. In addition to the improved statistics, an increase in the number of patients was also seen. The number of daily visits increased by an average of 2.25 patients per day or 51.4 patients per month. The acuity of the patients did not change, with an average admission rate of 21% noted in both 2012 and 2013. Patient satisfaction remained high at more than 90% during both years. The percentage of significant returns also remained constant at less than 1% in both 2012 and 2013. Assessment of the CMS (Centers for Medicare & Medicaid Services) Quality Measures and PRQS (Physician Quality Reporting System) Indicators do not reveal any change of statistical significance. The average of all providers was shown to be at or above the benchmark set for each measurement/indicator.

Cost-effectiveness of comprehensive medication reviews versus noncomprehensive medication review interventions and subsequent successful medication changes in a Medicare Part D population.

An estimated 1.5 million preventable medication-related adverse events occur annually, with some resulting in serious injury and even death. To help address this issue, the Centers for Medicare Medicaid Services (CMS) now require medication therapy management (MTM) programs to offer comprehensive medication reviews (CMRs) to all Medicare Part D beneficiaries at least once a year. During a CMR, patients receive an extensive amount of medication and educational information. In contrast, noncomprehensive medication reviews (non-CMRs) are more targeted and focus on resolving a particular medication-related problem (MRP) via short patient consultations, patient letters, and direct provider interventions. To conduct a cost-effectiveness analysis comparing CMRs with non-CMR interventions on successful medication regimen changes and reductions in adverse drug events (ADEs). This decision analytic model compared the cost-effectiveness of CMRs with other intervention methods (non-CMRs) from a payer's perspective. For this model, a successful outcome was defined as a beneficiary case devoid of an ADE due to MRPs. The model was extensively tested and subjected to a thorough one-way sensitivity analysis and a second-order probabilistic sensitivity analysis with 10,000 iterations from the variable distributions. Non-CMR interventions were less costly and more effective than CMRs. The point estimate for direct medical costs was $193 for CMRs and $157 for non-CMRs, and the estimated probability of avoiding an ADE was 0.93 and 0.94 for CMRs and non-CMRs, respectively. The 10,000 iteration-Monte Carlo simulation scatterplot and cost-effectiveness acceptability curve (CEAC) revealed a dominance by non-CMRs in preventing harmful ADEs from cost and effectiveness perspectives; however, there was an overlap in the 95% CIs for both cost and ADEs prevented. Despite this, a non-CMR intervention saved estimated $5,377.08 per ADE prevented. One-way sensitivity analysis indicated the results were sensitive to the cost of treating a preventable ADE. In 100% of cases, the CEAC demonstrated that non-CMRs were likely the most cost-effective intervention regardless of the health plan's willingness to pay. The cost-effectiveness acceptability curve suggests that non-CMR interventions were less costly and more effective than CMRs; however, there was overlap in the 95% CIs for costs and ADEs prevented. In all cases, the CEAC demonstrated that non-CMRs were the most economical intervention with regard to time and cost. Non-CMRs show promise as a viable method to address MRPs, reduce ADEs, and improve patient-related health outcomes.

Determinants of Patient Satisfaction with Urology Practice

IntroductionAlthough patient satisfaction surveys will be used by CMS (Centers for Medicare & Medicaid Services) to determine reimbursement in physician offices within 2 years, there are no published data to our knowledge on what influences patient satisfaction with the urology office. Therefore, we evaluated which parameters had the greatest impact on a patient’s likelihood to refer another patient to our practice. MethodsWe employed a national survey firm to mail patient satisfaction questionnaires consisting of 21 questions covering parameters on logistics, practice and physician interactions to a random subset of urology outpatients. Data on number of patients seen, wait time in clinic, survey response rate and likelihood to refer were also collected. Interrelations between survey parameters were analyzed using a Pearson product-moment correlation and Fisher’s transformation. ResultsDuring a 2-year period we received 58,932 responses to 211,679 surveys (27.8% response rate). Although logistical and staff parameters correlated positively with likelihood to refer, the strongest correlation was observed in physician parameters (r=0.947, p <0.01). Of physician parameters, patient confidence in physician correlated most strongly with likelihood to refer (r=0.976, p <0.01). Clinic wait time showed a relatively weak correlation to likelihood to refer (r= 0.500, p <0.01), while number of patients seen did not correlate to likelihood to refer (r=−0.090, p=0.40). Survey response correlated positively with likelihood to refer (r=0.593, p <0.01). ConclusionsOur large series demonstrates that patient satisfaction in the urology office correlates most strongly with patient-physician interaction. Implementation of systematic, comprehensive patient satisfaction surveys is feasible for urology practices and can provide meaningful data to enhance the patient experience.

Meaningful Use: An Update on the Electronic Health Record Incentive Program for Urologists

IntroductionMeaningful use is a federal incentive program designed to stimulate the adoption of health information technology and improve the quality of care delivery in the United States. This article provides a specialty specific perspective to clarify program details and review participation for the specialty of urology. MethodsPublicly available documents from CMS (Centers for Medicare & Medicaid Services), including program materials, participation and payment data, were reviewed to construct this narrative as well as statistics on adoption in urology. ResultsDetails of eligibility, participation, certification, attestation and payment are presented. Since program inception, 4,700 unique urologists have received payments totaling $95,864,021 or 2.4% of program payments. Of urologists who received payment for program year 2011, 14.8% did not receive a payment for program year 2012. Of eligible urologists 47.2% successfully attested for meaningful use in 2012. ConclusionsMeaningful use has stimulated the adoption of health information technology and about half of all eligible urologists have participated. There was a significant dropout rate in program year 2012 compared to 2011.

Analysis of costs to dispense prescriptions in independently owned, closed-door long-term care pharmacies.

The need for accurate calculation of long-term care (LTC) pharmacies' costs to dispense (CTD) has become more important as payers have moved toward reimbursement models based on pharmacies' actual acquisition cost for drug products and the Centers for Medicare Medicaid Services (CMS) has implemented requirements that LTC pharmacies must dispense prescriptions for certain branded drugs in 14-day-or-less quantities. To (a) calculate the average cost that the typical independently owned, closed-door LTC pharmacy currently incurs to dispense and deliver a prescription to the resident of a client LTC facility and (b) estimate how CMS-mandated changes to a 14-day-or-less dispensing cycle would affect the typical LTC pharmacy's average CTD. The data requirements and measurement model were developed by academic researchers in consultation with an industry advisory committee of independent LTC pharmacy owners. A survey instrument was constructed to collect financial and operating data required to calculate the CTD. Surveys were distributed via 3 dissemination channels to approximately 1,000 independently owned, closed-door LTC pharmacies. The National Community Pharmacists Association mailed surveys to their LTC members; 3 major national wholesalers distributed surveys to their LTC customers through their newsletters; and 3 LTC group purchasing organizations distributed the surveys to their members through emails, newsletters, mailings, and/or regional meetings. Each pharmacy's CTD was calculated by dividing total LTC dispensing-related costs by the total number of prescriptions dispensed. Dispensing-related costs included costs incurred to physically dispense and deliver prescriptions (e.g., dispensing pharmacists' and technicians' salaries and costs of medication containers) and costs incurred to support the dispensing function (e.g., salaries of delivery and medical records personnel). A model based on dispensing-related fixed, variable, and semivariable costs was developed to examine the impact of shorter dispensing cycles on LTC pharmacies' CTD. A prescription volume increase of 19% was assumed based on converting only solid oral branded drugs to short-cycle dispensing. A diverse sample of 64 closed-door LTC pharmacies returned usable surveys. Sales from dispensing to LTC facilities accounted for more than 98% of total sales. Respondents indicated that they currently dispensed 23% of total doses in 14-day-or-less cycles and 76% in 28-31 day cycles. Most pharmacies used automated medication packaging technology, heat and cold package sealers, bar code systems, sterile compounding hoods, LTC printers or labelers, and electronic prescribing. The median CTD was $13.54 with an interquartile range (25th to 75th percentiles) of $10.51 to $17.66. More than half of dispensing-related costs were from personnel expense, of which pharmacists and managers accounted for more than 40%. The results of the fixed and variable cost modeling suggested that converting solid oral brand-name drugs from 30-day to 14-day dispensing cycles would lower the median per prescription CTD to between $11.63 and $12.54, depending on the assumptions made about the effects of semivariable costs. However, this decrease in per prescription dispensing cost is dwarfed by an increase in total dispensing cost incurred by pharmacies that results from doubling the monthly volume of short-cycle prescriptions that must be dispensed. The result is that the typical LTC pharmacy in our sample incurred a CTD of $13.54 if the medication is dispensed in a 30-day cycle or $23.26 if the medication is dispensed in two 14-day cycles (at a cost of $11.63 for each cycle dispensed). Our results indicated a median CTD of $13.54 for the typical independently owned, closed-door LTC pharmacy. Moving to a shorter cycle would reduce pharmacies' average per-prescription CTD but would increase the number of prescriptions dispensed per month. Our results indicated that transitioning solid oral branded products to 14-day cycles would reduce the median CTD to a minimum of $11.63 but would increase total dispensing costs because each sold oral branded prescription would require twice the number of monthly dispensing events.

Cost variability of suggested generic treatment alternatives under the Medicare Part D benefit.

The substitution of generic treatment alternatives for brand-name drugs is a strategy that can help lower Medicare beneficiary out-of-pocket costs. Beginning in 2011, Medicare beneficiaries reaching the coverage gap received a 50% discount on the full drug cost of brand-name medications and a 7% discount on generic medications filled during the gap. This discount will increase until 2020, when beneficiaries will be responsible for 25% of total drug costs during the coverage gap. To examine the cost variability of brand and generic drugs within 4 therapeutic classes before and during the coverage gap for each 2011 California stand-alone prescription drug plan (PDP) and prospective coverage gap costs in 2020 to determine the effects on beneficiary out-of-pocket drug costs. Equivalent doses of brand and generic drugs in the following 4 pharmacological classes were examined: angiotensin II receptor blockers (ARBs), bisphosphonates, HMG-CoA reductase inhibitors (statins), and proton pump inhibitors (PPIs). The full drug cost and patient copay/coinsurance amounts during initial coverage and the coverage gap of each drug was recorded based on information retrieved from the Medicare website. These drug cost data were recorded for 28 California PDPs. The highest cost difference between a brand medication and a Centers for Medicare Medicaid Services (CMS)-suggested generic treatment alternative varied between $110.53 and $195.49 at full cost and between $51.37 and $82.35 in the coverage gap. The lowest cost difference varied between $38.45 and $76.93 at full cost and between -$4.11 and $18.52 during the gap. Medicare beneficiaries can realize significant out-of-pocket cost savings for their drugs by taking CMS-suggested generic treatment alternatives. However, due to larger discounts on brand medications made available through recent changes reducing the coverage gap, the potential dollar savings by taking suggested generic treatment alternatives during the gap is less compelling and will decrease as subsidies increase.

Round and Round We Go: The Development of an Effective, Sustainable Multidisciplinary Rounding Process

Regulatory and accrediting agencies have recently increased scrutiny of the environment in hospital surveys. Many findings are cited in “Infection Control” chapters. In early 2012, our acute care hospitals were surveyed by the Centers for Medicare/Medicaid Services (CMS) and cited for a number of environmental issues. There is very little information published or available in Infection Prevention (IP) courses regarding “how to” effectively conduct environment of care (EOC) rounds. Historically, EOC rounds were conducted only twice a year at our hospitals, we had no standardized tool, and no scoring mechanism. In addition, we found that Department Managers (DM) did not realize their responsibility toward assuring a clean and safe environment.

Generic drug discount programs: are prescriptions being submitted for pharmacy benefit adjudication?

In 2006, pharmacies began offering select generic prescription drugs at discount prices (e.g., $4 for a 30-day supply) through nonmembership and membership programs. As part of the contract in membership generic drug discount programs, the member agrees to forgo submission of the claim to the insurance company. Claims not submitted for insurance adjudication may result in incomplete pharmacy benefit manager (PBM) and health plan data, which could negatively influence adherence reporting and clinical programs. To address potentially missing claims data, the Centers for Medicare Medicaid Services (CMS) encourages Medicare Part D sponsors to incentivize network pharmacies to submit claims directly to the plan for drugs dispensed outside of a member's Part D benefit, unless a member refuses. The extent of PBM and health plan claims capture loss due to generic drug discount programs is unknown. To identify changes in levothyroxine utilizers' prescription claims capture rate following the advent of generic drug discount membership and nonmembership programs. This retrospective concurrent cohort study used claims data from 3.5 million commercially insured members enrolled in health plans located in the central and southern United States with Prime Therapeutics pharmacy benefit coverage. Members were required to be 18 years or older and younger than 60 years as of January 1, 2006, and continuously enrolled from January 1, 2006, through December 31, 2010. Members utilizing generic levothyroxine for at least 120 days during January 1, 2006, through June 30, 2006 (baseline period) from the same pharmacy group with supply on July 1, 2006, were placed into 1 of 3 pharmacy groups: (1) nonmembership (Walmart, Sam's Club, Target, Kroger, City Market, and King Soopers pharmacies), (2) membership (Walgreens, CVS, Albertsons, and Savon pharmacies), or (3) the reference group of all other pharmacies. The index date was defined as July 1, 2006. The levothyroxine claim providing supply on July 1, 2006, was the index claim. Members with a Kmart pharmacy index claim were excluded, since the Kmart membership drug discount program began prior to July 1, 2006. Levothyroxine claims capture nonpersistency, defined as the occurrence of a claim supply end date prior to a 180-day gap, was the primary outcome variable and was assessed from July 1, 2006, through June 30, 2010 (follow-up period). The odds of levothyroxine claims capture nonpersistency by pharmacy group were assessed using a logistic regression analysis adjusted for the following covariates: age, gender, median income in the ZIP code of residence (binomial for ≤ $50,000 vs. greater than $50,000), switch to a brand levothyroxine product during the follow-up period, index levothyroxine claim supply of 90 days or more, and index levothyroxine claim member cost share per 30-day supply in tertiles (≤ $5.00, $5.01-$7.99, ≥ $8.00). Of 2,632,855 eligible members aged 18 years or older, 13,427 met all study eligibility criteria. The baseline pharmacy groups were membership with 3,595 (26.8%), nonmembership with 1,919 (14.3%), and all other pharmacies with 7,913 (58.9%) members. The rates of levothyroxine claims capture persistency throughout the 4-year follow-up period were 85.4% for nonmembership (P = 0.593 vs. all other pharmacies), 77.7% for the membership group (P less than 0.001 vs. all other pharmacies), and 85.9% for all other pharmacies. The Kaplan-Meier comparison of claims capture persistency found nearly identical claims capture loss for the nonmembership compared with all other pharmacies group, and when compared in a multivariate logistic regression model, there was no difference in the odds of levothyroxine claims capture over 4 years follow-up (OR = 1.01, 95% CI = 0.88-1.16, P = 0.900). The membership generic drug discount programs (Walgreens, CVS, Alberstons, and Savon pharmacies) had a statistically significant 61% higher odds (OR = 1.61, 95% CI = 1.45-1.79, P less than 0.001) of levothyroxine claims capture nonpersistency. The onset of the difference between the membership group and the all other pharmacies group was temporally associated with the launch of the membership programs. In comparison to index levothyroxine member cost of ≤ $5.00 per 30-day supply, higher cost shares were associated with higher levothyroxine claims capture nonpersistency ($5.01 to $7.99 OR 1.34, 95% CI 1.19-1.52 and ≥ $8.00 OR 1.60, 95% CI 1.40-1.82). Among levothyroxine utilizers in 2006 (prior to the advent of drug discount programs), those with claims from a pharmacy that subsequently implemented a nonmembership generic drug discount program did not appear to have a different rate of levothyroxine claims capture than members from the reference group when followed through June 2010. Utilizers with claims from a pharmacy that subsequently implemented a membership program had a significantly lower levothyroxine claims capture rate. Increasing index levothyroxine member cost was associated with higher levothyroxine claims capture loss. Because the analysis could not directly measure claims capture loss associated with members who switched to a new pharmacy group without presenting their insurance information (e.g., membership discount programs), further research is needed to confirm these findings.

Long-term Medicaid excess payments from alleged price manipulation of generic lorazepam.

Cost savings from the use of generic drugs versus brand-name drugs are well known. Both private and public prescription drug plans encourage the use of generic drugs through a variety of mechanisms. The magnitude of cost savings for a given generic drug is dependent on the degree to which the generic market is competitive. Should the competitive structure become compromised, higher prices and reduced cost savings may result. An alleged conspiracy between Mylan Laboratories and its active-ingredient suppliers in 1997 was associated with an increase in seller concentration in the generic lorazepam market. The Federal Trade Commission (FTC) alleged that Mylan raised costs to consumers by $120 million because of price increases for generic lorazepam from March through December 1998 and for generic clorazepate from January through December 1998. In November 2002, a settlement with Mylan was approved by the FTC, and a federal district court required Mylan to pay $147 million, including $28.2 million to state agencies including Medicaid. To (a) describe the seller concentration in the national Medicaid generic lorazepam market over a 19-year period from January 1991 through December 2009, (b) estimate the excess payments for generic lorazepam by Medicaid between 1998 and 2009, and (c) investigate potentially increased utilization and prices of 2 substitute pharmaceuticals: branded lorazepam (Ativan) and generic alprazolam (another widely used intermediate-acting benzodiazepine). Using Medicaid State Drug Utilization Data from the Centers for Medicare Medicaid Services, we calculated the 4-firm concentration ratio (CR₄) and the Herfindahl-Hirschman Index (HHI) for the Medicaid generic lorazepam market, along with pre-rebate reimbursement for pharmacy claims, number of claims (utilization), and average pre-rebate reimbursement per claim (average "price") for generic lorazepam, from 1991 through 2009. Medicaid's excess payments were estimated under 2 different assumptions regarding what the average generic lorazepam price would have been in the absence of the alleged conspiracy. To find counterfactual prices, the average per-claim reimbursement for lorazepam for the 4 quarters prior to the alleged conspiracy, $6.80, was inflated using (a) the quarterly change in the average per-claim reimbursement for generic alprazolam and (b) the Consumer Price Index (CPI) for all urban consumers, all goods. Potential impact of the alleged conspiracy on the branded lorazepam and generic alprazolam markets was investigated. The average pre-rebate reimbursements per claim for generic lorazepam were $10.25, $23.12, and $8.48 in 1991, 1998, and 2009, respectively. For the same 3 years, CR₄ = 52.80, 76.02, and 86.74, while HHI = 905.71, 2,166.25, and 2,233.36. Medicaid's excess payments from 1998-2009 were estimated at approximately $625-$657 million. The data also suggest the possibility of small impacts on the utilization of branded lorazepam and the price of generic alprazolam. Prior to the alleged conspiracy in 1997, average pre-rebate reimbursement per claim for generic lorazepam was declining, while seller concentration was rising. After a jump in average payment per claim in the years immediately following the alleged conspiracy, prices have gradually returned to their pre-1998 levels. However, the generic lorazepam market was more concentrated in 2009 than prior to the alleged conspiracy.

Evaluation of pneumococcal vaccination rates after vaccine protocol changes and nurse education in a tertiary care teaching hospital.

Pneumococcal vaccination in eligible patients is recommended by the Infectious Disease Society of America and the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices. Because hospitalization provides an opportunity to vaccinate patients at high risk for developing serious pneumonia complications, eligibility screening and administration of the pneumococcal vaccine prior to discharge in qualified patients are evaluated by the Joint Commission and the Centers for Medicare Medicaid Services (CMS) as part of pneumococcal vaccination core quality measures. Among patients with an inpatient diagnosis of pneumonia in 2008, 56% in our 580-bed tertiary care teaching hospital, compared with 84% nationwide, received pneumococcal vaccination. To improve pneumococcal vaccination rates for all patients in the study facility and not just those with pneumonia, a multifaceted intervention including a revised nurse screening tool, rescheduling of the vaccine order, storage of the vaccine in automated dispensing cabinets on the nursing unit, and creation of a vaccine tracking system was developed and implemented between August 2009 and October 2009. To determine the impact of a multifaceted intervention on pneumococcal vaccine screening and administration rates in eligible patients according to the CDC recommendations who were admitted to an internal medicine unit of a tertiary care teaching hospital. All patients aged 18 years or older from 2 internal medicine units were identified during 4-month time intervals before (pre-intervention, April through July 2009) and after (post-intervention, November 2009 through February 2010) implementation of the multifaceted pneumococcal vaccine protocol. Of these, 150 patients from each 4-month period were randomly selected for electronic medical record review. Eligibility for pneumococcal vaccination was derived from the CDC recommendations and consensus of the vaccine steering committee at the study institution; the criteria included aged 65 years or older, admitting diagnosis of pneumonia, at least 1 of several chronic diseases, immunocompromising condition, cochlear implant, cerebrospinal fluid leak, current tobacco smoking, pregnancy or having a child in the home less than aged 6 months, or awaiting solid organ transplantation. Patients who had vaccine contraindications/precautions or had been vaccinated in the previous 5 years were ineligible. Data on demographics, presence of vaccine screening, indication, administration, rescheduling, and refusal were collected. The primary endpoint was the rate of pneumococcal vaccine administration in eligible medicine patients. Secondary endpoints included changes in screening rates, vaccine refusal, and order rescheduling. Descriptive statistics and Student's t-test were used to evaluate patient demographic data. Pearson chi-square was used to compare the pre- and post-implementation periods. The rate of pneumococcal vaccine administration in eligible patients significantly improved post-implementation compared with pre-implementation (74.2% vs. 19.1%, respectively, P < 0.001). Rates of vaccine screening were similar pre-implementation (96.0%) and post-implementation (99.3%, P = 0.056). The rates of vaccine refusal in the pre- and post-implementation periods did not significantly differ (10.6% vs. 22.6%, respectively, P = 0.203). Implementation of vaccine protocol changes was associated with improved pneumococcal vaccination rates in eligible medicine patients. Protocol changes were relatively easy to implement in a large institution, and a similar approach may be implemented at other institutions as an effective way to improve pneumococcal vaccination rates.

Coming soon: NIH genetic test registry

Coming soon: NIH genetic test registry

Compliance Requirements of PPACA

This course attempted to cover some of the major legislation that impacts the health care industry. Recently, some major health care legislation was passed and is in the process of implementation, Public Law 111-148 & Public Law 111-152 (2010). This is commonly referred to as the Patient Protection and Affordable Care Act (PPACA). One of the requirements of this act is generally believed to be to require a compliance program to be in place to ensure compliance with the Centers for Medicare & Medicaid Services (CMMS) requirements. This would be for all the entities that will be receiving CMMS reimbursement. The specific regulations regarding what the compliance program should include are yet to be published by Department of Human Health Services (DHHS) and should be forthcoming in the timeframe indicated in the new legislation. This paper takes a general look at the likely elements of the compliance program that entities will most likely have to have in place if they do not already as part of their policies and procedures, which will need to be updated to include and comply with the additional regulatory requirements.

Medicare Quality Improvement Organizations' Ambulatory Drug Therapy Improvement Activities and Partnerships With Medicare Part D Prescription Drug Plans and Medicare Advantage Plans

BACKGROUND: The Medicare Modernization Act (MMA) has provided an opportunity for quality improvement organizations (QIOs) to partner with Medicare Part D plan sponsors. These new relationships have developed into a set of diverse projects, each approved by the Centers for Medicare Medicaid Services. OBJECTIVE: To provide information about the scope of the projects being conducted by the QIOs and their partners. SUMMARY: The document describes a variety of quality improvement projects addressing medication use by beneficiaries enrolled in Medicare Part D.Private Medicare QIO contractors are implementing these projects in each state. Descriptions of each project were developed by individual QIOs with the assistance of lead staff for the Physician Practice/Pharmacy QIO SupportCenter for all QIOs nationwide. These projects vary in their complexity, in the quality measures used, and in the clinical processes and economic impact they seek to improve. The summaries in this supplement were prepared 6 months into ...

Adequacy of evolving national standardized terminologies for interdisciplinary coded concepts in an automated clinical pathway

Purpose. The purpose of this analysis was to determine the adequacy of evolving national standardized terminologies with regard to coded data elements (concepts) in an automated clinical pathway designed to drive adherence with the American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for Evaluation and Management of Chronic Heart Failure. Method. Concepts were identified in a previously developed automated clinical pathway and associated tools. Once identified, concepts were categorized according to the conceptual domains identified by Campbell et al. (1997). A review of evolving national standardized terminologies and coding systems was initiated to determine if the identified concepts had corresponding representation in one of these coding systems. Available codes were then evaluated for adequacy with respect to national guideline adherence measures put forth by the Centers for Medicare/Medicaid Services (CMS) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Results. The concept domain model put forth by Campbell et al. (1997) worked well for organizing concepts and for providing a useful framework for data analysis. Using our method, 260 unique pathway concepts were identified, of which, 91.9% (239) are represented by one or more of the standardized coding systems. Logical Observation Identifiers Names and Codes (LOINC) and SNOMED CT alone represented 86.2% of the concepts. Seventy percent (70%) of the clinical pathway concepts are represented using the Health Insurance Portability and Accountability Act (HIPAA) mandated national terminologies alone. Less than 50% of CMS and JCAHO guideline adherence concepts were found to have representation in the HIPAA mandated terminologies. The addition of Logical Observation Identifier Names and Codes (LOINC) and SNOMED CT improved representation up to 86.4%, but did not include representation of all concepts necessary for complete electronic monitoring of guideline adherence. Conclusions. Evolving national standardized terminologies provided matching terms for the majority of the data elements in the automated clinical pathway. Standard clinical terminologies with granular terms such as LOINC and SNOMED CT are required to represent the depth and detail of certain procedures and guideline-based care. Gaps exist in Health Insurance Portability and Accountability Act (HIPAA) mandated terminologies for representing interdisciplinary concepts in national adherence measures.