Friedman, B.

Lenhart, G.M.

Marder, W.D.

Wier, L.M.

Elsevier - Publisher Connector 

PHP137 The Effect Of Massachusetts Health Care Reform On Inpatient And Emergency Department Use 

 V A L U E  I N  H E A L T H  1 6  ( 2 0 1 3 )  A 1 - A 2 9 8  A267 
 
 
that a positive correlation exists in hospitals between service specialization and 
the level of clinical quality; furthermore, one also exists between clinical quality 
and financial performance. Finally, service specialization has a positive effect on 
financial performance, which is fully mediated by clinical quality. 
CONCLUSIONS: Based on a complete set of national data, this study 
demonstrates that hospital specialization has positive effects. Specialist hospital 
organizations provide superior quality of care and enhanced financial 
performance. Consequently, more specialization may prove to be a beneficial 
policy for the NHS.  
 
HEALTH CARE USE & POLICY STUDIES – Regulation of Health Care Sector 
 
PHP136  
PRE-MARKETING AUTHORIZATION OF NEW MEDICAL DEVICES IN THE 
EUROPEAN UNION AND THE UNITED STATES  
Abraham PS1, Gholmie J1, Seoane-Vazquez E1, Rodriguez-Monguio R2 
1Massachusetts College of Pharmacy and Health Sciences University, Boston, MA, USA, 
2University of Massachusetts, School of Public Health and Health Sciences,, Amherst, MA, USA  
OBJECTIVES: The European Union (EU) and the United States (US) have different 
regulatory systems for pre-marketing approval of medical devices (MDs) that 
result in differences in the MDs market authorizations and dates of market 
entry. This study analyzed differences between the MD regulatory systems in the 
US and the EU and evaluated the effect of those differences in pre-marketing 
authorization of new MDs in the period January 2000 to September 2012. 
METHODS: The study included a comparison of the regulation of MDs in the EU 
and the US and an analysis of MDs pre-marketing authorization dates in both 
systems in the period January 2000 to October 2012. Data were collected from the 
US Food and Drug Administration (FDA), companies’ webpages and a review of 
the literature. Descriptive statistics were used to compare differences in 
approval dates. Regression analysis was used to assess trends in differences in 
approval dates over the study period. RESULTS: There were important 
differences in pre-marketing approval systems for MDs between the US and the 
EU. More clinical information was required for approval of MDs in the US than in 
the EU. The FDA listed 514 new MDs approved in the study period. FDA pre-
marketing authorization and EU pre-marking authorization (i.e. CE mark) dates 
were available for 201 MDs. Approval of MDs occurred on average±stdev 
2.57±3.79 years earlier in the EU than in the US (median=2.42 years; 95%CI=1.86-
3.29 years). Overall, 171 MDs (85.1%) were authorized first in the EU. The 
difference in authorization dates grew over the study period at a rate of 
approximately 2.5 months per year. CONCLUSIONS: The EU and the US have 
different safety and efficacy regulatory requirements for MDs pre-marketing 
authorization. European patients have early access to new devices, whereas US 
patients have more MD-related information available for reimbursement and 
clinical decisions.  
 
PHP137  
THE EFFECT OF MASSACHUSETTS HEALTH CARE REFORM ON INPATIENT AND 
EMERGENCY DEPARTMENT USE  
Marder WD1, Wier LM1, Lenhart GM1, Friedman B2 
1Truven Health Analytics, Cambridge, MA, USA, 2Self Employed, Cambridge, MA,  
USA  
OBJECTIVES: The Commonwealth of Massachusetts implemented the first phase 
of a broad health care reform program from 2006 through 2008. The 
Massachusetts (MA) reform has increased insurance coverage and improved 
access to care. How the ACA will affect the hospital sector is undefined. The 
objectives of this study were to examine the effects of health care reform on 
inpatient services and emergency department visits in MA. METHODS: We used 
data from AHRQ's Healthcare Cost and Utilization Project (HCUP) State Inpatient 
Databases (SID) and the State Emergency Department Databases (SEDD). We 
implemented a difference-in-difference model to estimate the impact of the 
legislation and examined the changes between 2005 and 2009 in both MA and in 
control hospitals for a limited number of high-level indicators: discharges 
(overall and in selected categories); length of stay; cost per discharge; and 
emergency department (ED) visits and charges. We also estimated regression 
models that controlled for the hospital’s competitive environment for both the 
inpatient and ED variables. There were 64 MA hospitals with nonmissing values 
for all of the variables used in this study (62 with EDs). The control populations 
were propensity-score matched samples of hospitals drawn separately from the 
SID and the SEDD. RESULTS: Changes in inpatient utilization in MA were similar 
to those in other states. Length of stay declined more rapidly relative to the 
control sample (–6.0% versus –0.4%, respectively. The number of preventable 
hospitalizations for acute conditions declined in MA and the rest of the country. 
Hospitalizations associated with chronic conditions increased overall; results are 
at least suggestive that they rose faster in MA (0.05<p< 0.10). ED utilization grew 
in both groups, but ED charges per visit grew more slowly over the 5-year period 
in MA. CONCLUSIONS: Overall, the Massachusetts reform had modest effects on 
the hospital sector.  
 
PHP138  
PREDICTORS OF STATE ADOPTION OF FEDERAL HEALTH INSURANCE 
EXCHANGES  
Luong M1, Suh K1, Kiptanui Z2, Lu J3, Sikirica S4 
1Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 2University of Maryland, 
Baltimore, MD, USA, 3Scott & White Health Plan, Temple, TX, USA, 4Thomas Jefferson 
University, Philadelphia, PA, USA  
OBJECTIVES: Health insurance exchanges (HIX) are regulated, standardized 
online marketplaces that allow consumers to compare and purchase health 
insurance coverage. The U.S. Patient Protection and Affordable Care Act (2010) 
required all states and the District of Columbia to choose between establishing 
state-controlled HIX, either independently or through a state-federal 
partnership, or else defer to federally-controlled programs. Following a 
December 2012 decision deadline, 18 states and the District of Columbia opted to 
establish state-based programs, 7 states opted for partnership programs, and 25 
states defaulted to federally-controlled programs. The objective of this study was 
to examine variables associated with the adoption of federally-controlled HIX 
versus state-controlled and partnership HIX. METHODS: This descriptive, cross-
sectional study used publically available state-level data (n=51) from 2009 to 
2012. Information was obtained from sources such as the Kaiser Family 
Foundation and the Centers for Medicare and Medicaid Services. Chi-square 
analyses were performed on categorical variables in relation to federal versus 
state-controlled and partnership HIX and t-tests were used to compare means of 
continuous variables. RESULTS: 19 continuous and 5 categorical variables, 
including political, economic, and population health measures, were included in 
this analysis. Of these, political party of the governorship (p<0.001), 2012 
Electoral College result (p<0.01), decision regarding Medicaid expansion 
(p<0.001), unemployment rate (6.78% for federally-controlled HIX vs. 7.79% for 
state, p<0.05), and Medicaid enrollment in the <200% of Federal Poverty 
Guideline population (37.1% for federally-controlled HIX vs. 44.5% for state, 
p<0.05) were found to be significantly associated with default to federally-
controlled HIX. CONCLUSIONS: States that opted for, or defaulted to, federally-
controlled programs have shared political, economic, and population 
characteristics that may impact HIX design, implementation, and 
administration. Access to other state-level data may yield further significant 
findings.  
 
PHP139  
REVIEW OF FRANCE'S TRANSPARENCY COMMITTEE'S 2011-2012 
ASSESSMENTS  
Aggarwal S, Topaloglu H, Kumar S 
Novel Health Strategies, Bethesda, MD, USA  
OBJECTIVES: In France assessments by the Transparency Committee (TC) plays a 
significant role in pricing and market access of new products. TC evaluates 
clinical efficacy and safety data of new interventions, and compares it to current 
standard of care. TC’s assessments are made using ASMR ratings ranging from I 
to V (major innovation to no improvement). The objective of this study was to 
understand trends in TC’s assessments for new products approved by the EMA 
between 2011-2012. METHODS: TC’s assessments for 11 products approved by 
the EMA between 2011-2012 were analyzed for their ASMR ratings. Analysis was 
conducted to identify new trends and compare them for products based on their 
indications, comparators, and launch timing. RESULTS: Analysis of 2011-2012 
assessments by TC shows that the majority of products (73%) received an ASMR 
rating of IV (minor improvement). Approximately 27% of the products received 
an ASMR rating of III and V. A new trend in TC’s assessment is the assignment of 
two ASMR ratings for one product for different subgroups or patient line of 
treatment. During last one year 3 out of 11 products received two ASMR ratings. 
None of the products received ASMR ratings of I and II. The products that 
received ASMR rating of V (no improvement) were indicated for cardiovascular, 
epilepsy, and bone metastases. All assessments included analysis of 
intervention’s data versus one or more comparators. CONCLUSIONS: France TC’s 
assessments trends show a need for robust comparative effectiveness data to 
obtain better ASMR ratings, which affects both pricing and market access of new 
products. Future products would need subgroup analysis to obtain high ASMR 
ratings for all patient populations.  
 
PHP140  
CHARACTERISTICS OF COMMUNITY PHARMACIES IN CAIRO, EGYPT: RESULTS 
FROM THE FIRST WAVE OF A CROSS-SECTIONAL SURVEY  
Soliman AM1, Mohamed O2, Kaf HA3, Hussein M4 
1College of Pharmacy, University of Minnesota, Minneapolis, MN, USA, 2Misr International 
University, Cairo, Egypt, 3Ain Shams University, Cairo, Egypt, 4University of Tennessee Health 
Science Center, Memphis, TN, USA  
OBJECTIVES: In the pursuit of performance enhancement in the health care 
system in Egypt, particularly in the pharmaceutical sector, researchers face 
severe lack of relevant data. This limits our understanding of the health care 
system and the ability to detect policy-relevant problems. This is especially true 
for community pharmacies, which make the most easily accessible health care 
avenues for Egyptian households. We, therefore, sought to explore the 
characteristics of Egyptian community pharmacies in terms of labor force and 
practice patterns. METHODS: This is the first wave of a modified cross-sectional 
survey adapted from the US National Pharmacist Workforce Survey.  
We randomly sampled pharmacies located in the East and South regions of Cairo 
from addresses listed in Yellow Pages using a systematic random sampling 
methodology. Pharmacy data was collected through personal interviewing of the 
pharmacist on duty in the surveyed pharmacies. RESULTS: One-hundred- 
and-sixty-nine pharmacies participated in the survey (72% response rate). 
Independent pharmacies accounted for 88% of respondents. Only 35% of  
the pharmacies had a full time pharmacist, while 20% suffered recent layoffs  
of pharmacists. Virtually all pharmacies offered disease and medication 
counseling, 58% offered compounding services, 56% offered drug information 
services, and 40% carried durable medical equipments. Respondent pharmacists 
were on average 31.6 years old; 62% were male; the majority (94%) had only  
the bachelor's of pharmacy degree; work 56.3 hours per week; and receive  
6.05 Egyptian Pounds (EGP) (~ $1) per hour in compensation. Males reported 
working more weekly hours (58.8 vs. 52.4, p=0.02) but the average hourly  
rate was not statistically different from females (6.12 vs. 5.94 EGP, p=0.2). 
CONCLUSIONS: This study illustrates an ongoing effort to document  


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PHP137 The Effect Of Massachusetts Health Care Reform On Inpatient And Emergency Department Use

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