BMS Publications

	La Jolla, April 30, 2008 - CMS published the Proposed Rule for the Federal FY 2009 Inpatient Prospective Payment System (IPPS) (73 FR 23528). This document announces the the Administration’s plans for changes in Medicare hospital payments in the next Federal fiscal year. This proposal includes a very positive assessment of the eligibility of the TherOx Downstream® system for New Technology Add-On Payments. These payments compensate the hospital for its costs for using a new technology that offers substantial clinical benefits for the patient. In the case of the Downstream® system, patients with acute myocardial infarct (AMI, “heart attack”) are treated with an infusion of oxygenated blood after placement of a stent to open the coronary artery. This procedure results in a very substantial decrease in the amount of scar tissue formed and preserves heart muscle and function. CMS has very high standards for proof that the new technology meets the requirements of the program, and a critical component of a CMS decision to approve these payments is data that proves that the hospitals’ charges for patients receiving the new technology are expected to exceed a threshold that CMS establishes. In addition to advising TherOx on their successful presentation of clinical data to CMS, BMS carried out and submitted the economic analysis that received CMS’ favorable assessment. This analysis included the collection and analysis of hospital charges for patients in the pivotal clinical trial as well as an analysis of CMS’ database of historical data for similar patients. (Final approval of the add-on payments is pending FDA approval of the Downstream® system, and CMS' publication of a Final Rule this Summer.)
	La Jolla, June 12, 2006 - BioMedical Strategies LLC (BMS) has filed a Comments Letter in response to the Centers for Medicare and Medicaid Services (CMS) April 12th Inpatient Prospective Payment System (IPPS) Proposed Rule. BioMedical Strategies’ comment letter focuses on the proposed introduction of “consolidated severity-adjusted DRG” methodology as well as “HSRVcc” cost-based weights to the IPPS. BMS’ letter asserts that the proposed rule is based on flawed methodology and does not meet CMS’ needs. Furthermore, CMS relies on proprietary software and may not be in compliance with Public Law 104-113, the National Technology Transfer and Advancement Act of 1995. BMS proposes that CMS employ methodology based on a consensus standards process that is in compliance with PL 104-113. In addition, BMS proposes that a reformed IPPS system should use statistical methodology for severity adjustment, that it should address best practice guidelines and outcomes, and that it be based on the ICD-10 procedure coding system. Please click here to read a copy of BioMedical Strategies’ Comments Letter
	White Paper by Frederick Cahn, Ph.D., CEO of BioMedical Strategies. "Medical Device Reimbursement: Using Data to Drive Strategy." With more than 30 years of experience in all aspects of product development, including scientific research, marketing, and clinical studies, Dr. Cahn helps medical device companies bring their products to market quickly and profitably.

Additional Publications & Patents

      • Cahn, F., E.M. Schachter, and A. Rich, "Polypeptide Synthesis with Ribonuclease Digested Ribosomes", Biochemica and Biophysica Acta, 209: 512 520 (1970).

      • Cahn, F. and M. Lubin, "Antiviral Drugs and Protein Synthesis in Reticulocyte Lysates", Intervirology, 1: 376 385 (1973).

      • Cahn, F. and M. Lubin, "Ability of Formyl methionyl tRNA to Initiate Globin Synthesis in the Presence of Double Stranded RNA or in the Absence of Hemin", Molecular Biology Reports, 2: 49 57 (1975).

      • Cahn, F. and M. Lubin, "Inhibition of Elongation Steps of Protein Synthesis at Reduced Potassium Concentrations in Reticulocytes and Reticulocyte Lysate", The Journal of Biological Chemistry, 253: 7798 7803 (1978).

      • Lubin, M., F. Cahn, and B.A. Coutermarsh, "Amiloride, Protein Synthesis, and Activation of Quiescent Cells", Journal of Cellular Physiology, 113: 247 251 (1982).

      • Cahn, F. and S. Compton, Multivariate Calibration of Infrared Spectra for Quantitative Analysis Using Designed Experiments, Applied Spectroscopy, 42:865-872 (1988).

      • Adema, E., D. Shnek, F. Cahn, and A.J. Sinskey, Use of porous microcarriers in agitated cultures, BioPharm, 3:20-23 (1990).

      • Cahn, F., "Biomaterials aspects of porous microcarriers for animal cell culture", Trends in Biotechnology, 8:131-136 (1990).

      • Tres. L.L., F. Cahn and A.L. Kierszenbaum, "Rat Sertoli-spermatogenic cell co¬cultures established on collagen-glycosaminoglycan crosslinked copolymers", Journal of Tissue Culture Methods, 14:265-269 (1992).

      • Cahn, F., Immunostimulatory Microsphere, U.S. Patent 5,008,116 (1991).

      • Foran, D.J., F. Cahn, and E.F. Eikenberry, "Cellular growth on porous microcarriers analyzed using statistical image processing", Analytical and Quantitative Cytology and Histology, 13:215 22 (1991).

      • Dean, RC., F. Cahn, and P.G. Phillips, Weighted Microsponge for Immobilizing Bioactive Material, U.S. Patent 5,100,783 (1992).

      • Tres. L.L., F. Cahn and A.L. Kierszenbaum, "Rat Sertoli-spermatogenic cell co¬cultures established on collagen-glycosaminoglycan crosslinked copolymers", Journal of Tissue Culture Methods, 14:265-269 (1992).

      • Tres, L.L., F. Cahn, and A.L. Kierszenbaum, "Permeable collagen-glycosaminoglycan crosslinked copolymers for the study of biological responses of cocultured Sertoli and spermatogenic cells", Cell Biology and Toxicology, 8:61-71 (1992).

      • Burke, J.F., F. Cahn, and J. O’Grady, Integra™ Artificial Skin physician training manual, Integra LifeSciences Corporation (1996).

      • Cahn, F., Method of Making a Porous Matrix, U.S. Patent 5,629,191 (1997)

      • Cohenford, M.A., T.A. Godwin, F. Cahn, P. Bhandari, T.A. Caputo, and B. Rigas, “Infrared spectroscopy of normal and abnormal cervical smears: evaluation by principal component analysis,” Gynecol Oncol. 66:59-65 (1997)

      • Cohenford, MA., PS Bhandare, F Cahn, K Krishnan, B Rigas, Method for the detection of cellular abnormalities using infrared spectroscopic imaging US Patent 5,976,885 (1999)

      • Cohenford M.A., P.S. Bhandare, F. Cahn, K Krishnan, B Rigas, Method for the detection of malignant and premalignant stages of cervical cancer . US Patent 6,031,232 (2000)

      • Cahn, F., Review: Technologies and Characteristics of Tissue-Engineered Skin Substitutes e-biomed 1:145-155 (2000).

      • Cahn, F., Modification of natural polymers: Collagen-glycosaminoglycan copolymers In Methods of Tissue Engineering (A. Atala and R.P. Lanza, eds.) Academic Press, New York, pp. 515-524 (2002)

      • Standard Guide for Classification of Therapeutic Skin Substitutes, Standard F2311-06, ASTM International (2003)

      • Cohenford, MA, PS Bhandare, F Cahn, K Krishnan, B Rigas, Method for the detection of cellular abnormalities using Fourier transform infrared spectroscopy. US Patent 6,620,621 (2003)

      • Cahn, F. and M. White, Wound closure system and methods. International Patent Application No. PCT/US20050/16321 (2005)

      • Mattern, RH, MD Pierschbacher, F Cahn, JF Tschopp, T Malaney, Collagen/glycosamino-glycan matrix stable to sterilizing by electron beam radiation. US Patent 6,969,523 (2005)

      • J. Arvesen, Jackknifing U-Statistics, The Annals of Mathematical Statistics, December, 1969, p.2076-2100.

      • J. Arvesen and T. Schmitz, Robust procedures for variance component problems using the jackknife, Biometrics, December, 1970, p.677-686.

      • J. Arvesen and B. Rosner, Optimal Pari-Mutuel Wagering, Purdue symposium in Decision Theory, p. 239-254, edited by S. Gupta and J. Yackel, published by Academic Press, 1971.

      • G. McCabe, J. Arvesen and R. Pohl, A computer program for subset selection in regression analysis, Mimeo series, No. 317, Department of Statistics, Purdue University, 1973.

      • J. Arvesen and B. Rosner, Multivariate analysis of horse race betting, Proceedings of the Business and Economic Statistics Section of the American Statistical Association, p. 238-240, 1973.

      • J. Arvesen and G. McCabe, Subset selection problems for variances with applications to regression analysis, Journal of the American Statistical Association, March, 1975, p. 166-170.

      • G. McCabe and J. Arvesen, A subset selection procedure for regression variables, Mimeo series, Department of Statistics, Purdue University, 1974.

      • J. Arvesen and M. Layard, Asymptotically robust tests in unbalanced variance component models, The Annals of Statistics, September, 1975, p. 1122-1134.

      • J. McKie, J. Seo and J. Arvesen, Rapid determination of minimum inhibitory concentrations of antimicrobial agents by regression analysis of light scattering data, Antimicrobial Agents and Chemotherapy, May, 1980, p.813-823.

      • J. Arvesen, Method and apparatus for determining the minimum concentration of antibiotic necessary to at least inhibit microorganism growth. US Patent 4,236,211 (1980).

      • J. Arvesen and M. Layard, Jackknife techniques in practice, Statistics in the Pharmaceutical Industry, p.435-448, edited by C. Buncher and J. Tsay, book published by M. Dekker, Inc., 1981.