Immigrant Health, Value-Based Care, and Emergency Medicaid Reform

Functional tests used in the catheterization laboratory have emerged as a very important adjunctive tool to coronary angiography that can identify patients with myocardial blood flow impairment. Fractional Flow Reserve (FFR) measurement is highly recommended for detection of ischemia-related coronary lesion(s) when objective evidence of vessel-related ischemia is not available. Recently, the much simpler instantaneous wave free ratio (iFR) was proposed as an alternative to FFR without the requirement for administration of vasodilators. More user-friendly techniques like iFR might further contribute to value-based care in coronary interventions.

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A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries

Applied Clinical Research Clinical Trials and Regulatory Affairs ◽

10.2174/2213476x07666200708105237 ◽

2020 ◽

Vol 7 (3) ◽

pp. 162-176

Author(s):

Kapil Pihwal ◽

Neelam Pawar ◽

Sheikh Aamir ◽

Mohammad Shahbaz Alam ◽

Vikas Rathee

Keyword(s):

Regulatory Requirements ◽

Health Value ◽

Drug Products ◽

Registration Process ◽

Potential Market ◽

Regulatory Guidelines ◽

Cis Countries ◽

In Cis ◽

Regulatory Organization ◽

Country Specific

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization and it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also imposing strict rules and expecting USFDA level documents for approval. Conclusion: The overall conclusion is that harmonization in CIS is highly imbalanced, which affects both time and cost for product registration. Harmonization is the need of the era for easy product registration, and it will be beneficial for the manufacturer, regulator, importer, exporter, and to access medicines of high public health value.

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Differences in Hospital Costs among Octogenarians and Nonagenarians Following Primary Total Joint Arthroplasty

Geriatrics ◽

10.3390/geriatrics6010026 ◽

2021 ◽

Vol 6 (1) ◽

pp. 26

Author(s):

Christopher Fang ◽

Andrew Hagar ◽

Matthew Gordon ◽

Carl T. Talmo ◽

David A. Mattingly ◽

...

Keyword(s):

Length Of Stay ◽

Total Joint Arthroplasty ◽

Hospital Costs ◽

Cost Effective ◽

Joint Arthroplasty ◽

Nursing Facilities ◽

Activity Based Costing ◽

Skilled Nursing ◽

Value Based Care ◽

Hospital Expenses

The proportion of patients over the age of 90 years continues to grow, and the anticipated demand for total joint arthroplasty (TJA) in this population is expected to rise concomitantly. As the country shifts to alternative reimbursement models, data regarding hospital expenses is needed for accurate risk-adjusted stratification. The aim of this study was to compare total in-hospital costs following primary TJA in octogenarians and nonagenarians, and to determine the primary drivers of cost. This was a retrospective analysis from a single institution in the U.S. We used time-drive activity-based costing (TDABC) to capture granular total hospital costs for each patient. 889 TJA’s were included in the study, with 841 octogenarians and 48 nonagenarians. Nonagenarians were more likely to undergo total hip arthroplasty (THA) (70.8% vs. 42.4%; p < 0.0001), had higher ASA classification (2.6 vs. 2.4; p = 0.049), and were more often privately insured (35.4% vs. 27.8%; p = 0.0001) as compared to octogenarians. Nonagenarians were more often discharged to skilled nursing facilities (56.2% vs. 37.5%; p = 0.0011), experienced longer operating room (OR) time (142 vs. 133; p = 0.0201) and length of stay (3.7 vs. 3.1; p = 0.0003), and had higher implant and total in-hospital costs (p < 0.0001 and 0.0001). Multivariate linear regression showed implant cost (0.700; p < 0.0001), length of stay (0.546; p < 0.0001), and OR time (0.288; p < 0.0001) to be the strongest associations with overall costs. Primary TJA for nonagenarians was more expensive than octogenarians. Targeting implant costs, length of stay, and OR time can reduce costs for nonagenarians in order to provide cost-effective value-based care.

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