GENZYME CORPORATION for GENZYME CORPORATION

Copyright/Patent/Trademark CPT

e) Patent reform issues. f) H.R. 1908 "Patent Reform Act of 2007" g) S.1145, "Patent Reform Act of 2007" a) Patent framework affecting generic biologics. b) S.1695, "Biologics Price Competition and Innovation Act of 2007 c) S.623, "Access to Life-Saving Medicine Act" d) H.R. 1038, Access to Life-Saving Medicine Act"

Contacted: Health & Human Services, Dept of (HHS); Agency for Healthcare Research & Quality (AHRQ); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Patent & Trademark Office (PTO); SENATE

Bills named: S. 1695 (110th), H.R. 1908 (110th), H.R. 1038 (110th), S. 623 (110th), S. 1145 (110th)

Medicare/Medicaid MMM

d) S.691/H.R. 1193 The Kidney Care Quality and Education Act e) H.R. 3162, The Children's Health and Medicare Protection Act of 2007 f) CPT Coding decisions g) Reimbursement for Part B Drugs administered in hospital outpatient departments, dialysis centers and physician officers. h) Implementation of the Competitive Acquisition (CAP) Program for Part B Drugs. i) 340B Programs. j) CMS guidance on coverage under evidence development. k) Physicians fee schedule payment rates for lab tests. l) Medicaid budget reductions. m) Medicaid rebates n) H.R. 2184, the Enhanced Health Care Value for All Act o) Technology assessment report on osteoarthritis treatments a) Medicare Prescription Drug Benefit: Implementation of issues associated w/P.L. 108-173, including reimbursement for orphan drugs. b) H.R. 1321 “Medicare Advanced Laboratory Diagnostics Act of 2007”, reimbursement for lab tests c) Bundling Payment system for dialysis centers

Contacted: Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Patent & Trademark Office (PTO); Executive Office of the President (EOP); Food & Drug Administration (FDA); SENATE; HOUSE OF REPRESENTATIVES; Agency for Healthcare Research & Quality (AHRQ)

Bills named: H.R. 1193 (110th), S. 691 (110th), H.R. 3162 (110th), H.R. 2184 (110th), H.R. 1321 (110th)

Pharmacy PHA

e) Senate Concurrent Resolution 21 f) S.251, Pharmaceutical Market Access & Drug Safety Act of 2007" - Importation. g) S. 242, "Pharmaceutical Market Access & Drug Safety Act of 2007" a) Issues related to Drug Safety, Generic Biologics & Drug Approvals, FDA User Fees. b) S.1082, "Food & Drug Administration Revitalization Act of 2007" c) H.R. 2900, "Food & Drug Administration Amendments Act of 2007" d) H.R. 380, "Pharmaceutical Market Access and Drug Safety Act of 2007" - Importation.

Contacted: Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Patent & Trademark Office (PTO); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Agency for Healthcare Research & Quality (AHRQ); SENATE; Executive Office of the President (EOP)

Bills named: S. 1082 (110th), S. 251 (110th), S. 242 (110th), H.R. 2900 (110th), H.R. 380 (110th)

Medical/Disease Research/Clinical Labs MED

e) S.1082 "FDA Revitalization Act of 2007" Provision Re: IOM Lab Study f) S.736, "The Laboratory Test Improvement Act" a) Reimbursement for clinical lab services under Medicare. b) H.R. 1321 "Medicare Advanced Laboratory Diagnostics Act" c) S.976 "Genomics & Personalized Medicine Act of 2007" d) Competitive bidding for lab tests

Contacted: HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Executive Office of the President (EOP); Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Agency for Healthcare Research & Quality (AHRQ); Patent & Trademark Office (PTO); SENATE

Bills named: S. 736 (110th), S. 1082 (110th), H.R. 1321 (110th), S. 976 (110th)