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Medicare & Biotech: Ensuring Patient Access to Breakthrough Therapies
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Established in 1965, the Medicare program provides health insurance for 40 million senior citizens and disabled individuals - the same populations many biotech products are designed to help. Representing an industry that is devoted to discovering new cures, BIO has long supported patient access to critical biotech therapies under the Medicare program. In 2003, Congress passed landmark legislation to add prescription drug coverage to Medicare and modernize the benefit structure to provide patients with access to breakthrough biotechnology medicines.
Medicare Prescription Drug Coverage (Medicare Part D):
Comments on the Medicare Advantage-Prescription Drug (MA-PD), Cost-Based Plan, and Stand Alone Prescription Drug Plan (PDP) (January 30, 2008)
BIO's comment on the Centers for Medicare & Medicaid Services’ Draft 2009 Medicare Advantage
Read the letter (190 KB PDF)
Comments on the USP Draft Medicare Model Guidelines Version 4.0 (December 6, 2007)
BIO letter to the United States Pharmacopeia regarding the USP Draft Medicare Model Guidelines
Read the letter (190 KB PDF)
Technical Changes to the Medicare Prescription Drug Benefit (July 24, 2007)
BIO letter to CMS
Read the letter (249 KB PDF)
BIO opposes the Chairman's Mark to the Medicare Prescription Drug Price Negotiation Act of 2007 (S. 3) (April 11, 2007)
BIO letter to Senators Baucus and Grassley
Read the letter (114 KB PDF)
Read the press release
CMS' Draft 2008 Call Letter (April 3, 2007)
BIO's Comments.
Read the comments (124 KB PDF)
Survey on Savings Part D (February, 2007)
Survey Finds Private Sector Negotiations Provide Both Savings and Choice, Making Government Interference Unnecessary.
Read the comments (97 KB PDF)
Read the press release
CMS' Medicare Part D Data (December 18, 2006)
Comments to agency's Proposed Rule regarding collection of and access to claims data under Medicare Part D.
Read the comments (97 KB PDF)
USP's Draft Medicare Model Guidelines Version 3.0 (December 8, 2006)
BIO's comments
Read the comments (167 KB PDF)
Beneficiary Access to Vaccines Under Part D (November 16, 2006)
BIO's letter to CMS Acting Administrator Leslie Norwalk
Read the letter (35 KB PDF)
Draft of Chapter 6 of the Medicare Part D Manual. (September 26, 2006)
Comments to CMS on the draft.
Read the comments (116 KB PDF)
"National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development (CED)." (September 22, 2006)
Comments to CMS on the guidance document
Read the comments (99 KB PDF)
Medicare Prescription Drug Benefit Manual ñ Draft Chapter 5 (September 18, 2006
Comments to CMS
Read the comments (81 KB PDF)
Comments on on CMS' Draft Guidelines- Formularies (March 6, 2006)
Read the comments. (100 KB PDF)
Comments on the Revised Model Guidelines
To United States Pharmacopeia (January 6, 2006)
Read the comments. (46 KB PDF)
Comments on Safe Harbor for Electronic Prescribing
BIO's comments on the Office of Inspector GeneralÃs proposed Rule regarding new Safe Harbors for e-prescribing. (December 13, 2005)
Read the comments. (63 KB PDF)
Comments on CMS's Draft Formulary Review Criteria
as posted on CMS's Web site on December 3, 2004. (December 23, 2004)
Read the comments. (188 KB PDF)
Comments on CMS's Draft Decision Memorandum for Anticancer Chemotherapy for Colorectal Cancer.
CAG-00179N. (December 23, 2004)
Read the comments. (116 KB PDF)
Comments on CMS' proposed rule regarding the Medicare Part D prescription drug benefit
Federal Register CMS-4068-P, August 3, 2004. (October 4, 2004)
Read the comments. (272 KB PDF)
Comments on Medicare Prescription Drug Benefit Model Guidelines
Comments to United States Pharmacopeia's draft Medicare Prescription Drug Benefit Model Guidelines. (September 17, 2004)
Read BIO's comments. (144 KB PDF)
U. S. Pharmacopeia Medicare Prescription Drug Benefit Model Guidelines
Presentation before a Public Meeting (Aug. 27, 2004)
Read the Presentation
Reimbursement for Physicians in Inpatient and Outpatient Settings (Medicare Parts A & B):
Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates (June 13, 2008)
BIO's comments to the CMS regarding Hospital Inpatient Prospective Payment Systems for 2009
Read the comments (169 KB PDF)
Positron Emission Tomography for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (May 9, 2008)
BIO's comments to the CMS regarding the tracking sheet and prospective data collection requirements
Read the comments (73 KB PDF)
Medicare Program; Town Hall Meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) (April 3, 2008)
BIO's comments to the CMS April 30th public meeting of MedCAC
Read the comments (192 KB PDF)
Statement to the Coverage and Analysis Group of the Centers for Medicare & Medicaid Services (March 14, 2008)
BIO's comments to the CMS regarding adding compendia for the purposes of making medicare coverage determinations
Read the comments (110 KB PDF)
Statement to the Advisory Panel on Ambulatory Payment Classification Groups (March 7, 2008)
BIO's testimony before the Advisory Panel on Ambulatory Payment Classifications regarding the policies the CMS has adopted and is considering adopting for drug and biological therapies
Read the comments (216 KB PDF)
Comments on the changes to the Hospital Outpatient Prospective Payment System (January 28, 2008)
Bio's comments on the CMS final rule regarding revisions to the hospital outpatient prospective payment system and 2008 payment rates
Read BIO's comments (214 KB PDF)
Proposed changes to the 2010 Healthcare Common Procedure Coding System (HCPCS) (December 10, 2007)
Bio's comments on proposed changes to the 2010 HCPCS Level II Modification Process
Read BIO's comments (192 KB PDF)
Proposed changes to the 2009 Healthcare Common Procedure Coding System (HCPCS) (September 18, 2007)
Bio's comments on proposed changes to the 2009 HCPCS Level II Modification Process
Read BIO's comments (197 KB PDF)
Evidentiary Priorities for the Medicare Program (September 17, 2007)
Bio's comments on the Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC)
Read BIO's comments (198 KB PDF)
Proposed Changes to the Hospital Outpatient Prospective Payment System (OPPS) (September 14, 2007)
BIO's comments to CMS regarding proposed changes
Read BIO's comments (649 KB PDF)
Proposed Revisions to Payment Policies Under the Physician Fee Schedule (August 31, 2007)
Bio's comments on
Read BIO's comments (872 KB PDF)
Proposed Decision Memorandum for Second Reconsideration of the Medicare Clinical Trial Policy (August 17, 2007)
Bio's comments on the CMS' Proposed Decision Memorandum.
Read BIO's comments (553 KB PDF)
Erythropoiesis Stimulating Agents (ESAs) (June 13, 2007)
BIO's comments regarding CMS' proposed restrictions for FDA approved uses and off-label uses.
Read BIO's comments (201 KB PDF)
Inpatient Prospective Payment System (June 12, 2007)
BIO's comments regarding CMS' proposed 2008 changes.
Read BIO's comments (232 KB PDF)
CMS Proposed Decision Memo for the Medicare Clinical Trial Policy (May 10, 2007)
Read BIO's comments (90 KB PDF)
APC Panel (February 2007)
BIO's testimony before the Advisory Panel on Ambulatory Payment Classification Groups
Read the testimony (70 KB PDF)
FY 2008 Applications for New Medical Services and Technologies (February 6, 2007)
BIO's Comments on the Town Hall Meeting
Read the comments (72 KB PDF)
Proposed Changes to CMS' Clinical Trial Policy (December 13, 2006)
BIO's presentation to MCAC
Read the statement (90 KB PDF)
Cancer Journals in Medicare Benefit Policy Manual (November 22, 2006)
BIO's comments to CMS including list of recommended journals to be added
Read the comments (64 KB PDF)
List of recommended journals (31 KB PDF)
Noridian Administrative Services' draft policies for MAC Jurisdiction 3 (October 31, 2006)
BIO's Comments
Read the comments (66 KB PDF)
Physician Fee Schedule (October 10, 2006)
BIO's Comments to CMS
Read the comments (213 KB PDF)
Hospital Outpatient Prospective Payment System (October 10, 2006)
BIO's Comments to CMS
Read the comments (111 KB PDF)
Findings from a replication of the CMS ASP+5% calculation (October 6, 2006)
From the Moran Company
Read the memo (220 KB PDF)
Comments to CMS on the RVU's and Practice Expense Methodology (August 21, 2006)
BIO's comments regarding the CMS proposed notice on the five-year review of work relative value units (RVUs) and proposed changes to the practice expense methodology under the physician fee schedule.
Read the comments (55 KB PDF)
APC Panel (August 18, 2006)
BIO's testimony before the Advisory Panel on Ambulatory Payment Classifications (the APC Panel)
Read the testimony
Comments on NCA Tracking Sheet for Clinical Trial Policy
BIO's comments on the CMS' Tracking Sheet regarding the development of a Clinical Research Policy (CRP) as a reconsideration of its national coverage decision (NCD) on Medicare coverage of clinical trials.
Read the comments (92 KB PDF)
A side-by-side summary of BIO's comments to the IPPS proposed rule and CMS' response
Learn more.
Comments to CMS' proposed rule regarding the competitive bidding program for DMEPOS (June 30, 2006)
Read the comments. (101 KB PDF)
Comments to CMS on Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates (June 12, 2006)
Read the comments. (88 KB PDF)
BIO's Comments to NHIC regarding the draft LCD for Gonadotropin-Releasing Hormone Analogs (June 2, 2006)
Read the comments. (54 KB PDF)
Comments on Authoritative Drug Compendia
BIOÃs Comments on Authoritative Drug Compendia That May Be Used in Determining Medically Accepted Indications of Drugs and Biologicals Used in an Anti-Cancer Chemotherapeutic Regimen. (February 27, 2006)
Read the comments. (71 KB PDF)
BIO's Testimony
before the Advisory Panel on Ambulatory Payment Classification Groups(March 1-3, 2006)
Read the comments.
Comments on Exclusion of Vendor Purchases
BIO's Comments on the Centers for Medicare and Medicaid Servicesà interim final rule regarding exclusion of vendor purchases made under the Competitive Acquisition Program (CAP) for outpatient drugs and biologicals under Part B. (January 20, 2006)
Read the comments. (77 KB PDF)
Comments on Proposed Bulletin for Good Guidance Practices
BIO's comments on the Proposed Bulletin for Good Guidance Practices released by the Office of Management and Budget (OMB). (January 9, 2005)
Read the comments. (31 KB PDF)
Comments on Outpatient Prospective Payment System
BIO's comments on the Centers for Medicare and Medicaid Servicesà final rule regarding revisions to the hospital outpatient prospective payment system (OPPS). (January 9, 2005)
Read the comments. (64 KB PDF)
Comments on Revisions to Payment Policies and the Competitive Acquisition Program
BIO's Comments on the Centers for Medicare and Medicaid Services' final rule regarding revisions to payment policies under the Medicare physician fee schedule and certain provisions related to the Competitive Acquisition Program. (December 23, 2005)
Read the comments. (66 KB PDF)
Comments on Part B Local Coverage Determinations regarding drugs and their covered Diagnosis
BIOÃs comments on Noridian Admistrative Servicesà draft LCD regarding drugs and their covered diagnosis. (December 14, 2005)
Read the comments. (36 KB PDF)
BIO comments regarding manufacturer submission of average sales price data.
42 CFR 414.804 (CMS-10110) October 14, 2005 (45 KB PDF)
Read the comments.
BIO comments regarding coverage with evidence development.
June 6, 2005 (704 KB PDF)
Read the comments.
Oral Statement Before the Advisory Panel on Ambulatory Payment Classification Groups
February 23-25, 2005
Read the statement.
Comments on CMS's Revisions to Payment Policies Under Medicare Physician Fee Schedule
CMS-1429-FC. (December 27, 2004)
Read the comments. (146 KB PDF)
Comments to the hospital outpatient prospective payment system (HOPPS)
Relating to CMS' proposed rule revisions from the Federal Register CMS-1427-P, August 16, 2004 (October 8, 2004)
Read the comments. (158 KB PDF)
Comments to Medicare physician fee schedule payment policies
Relating to CMS's proposed rule revisions (September 24, 2004)
Read the comments. (167 KB PDF)
Testimony on 2005 OPPS Proposal and Other Medicare Issues
Presented to the APC Advisory Panel (Sep. 2, 2004)
Read the Testimony
Medicaid:
Comments on the treatment of prescription drugs under the Medicaid Drug Rebate Program (December 21, 2007)
A letter from BIO to CMS regarding the Final Rule with comment period.
Read the letter (244 KB PDF)
BIO's Letter to Jimmy Mitchell from HRSA (April 16, 2007)
Regarding their letter to Pharmaceutical Manufacturers on the definition of AMP used to calculate 340B ceiling prices.
Read the letter (125 KB PDF)
Proposed Rule on Medicaid Program; Prescription Drugs (February 20, 2007)
Comments regarding the treatment of prescription drugs under the Medicaid Drug Rebate Program
Read the comments (223 KB PDF)
Other Agency Notices:
Steps Tricare Management Activity (TMA) has taken to implement a new rebate regime (April 10, 2008)
Comments on prescriptions filled through the Tricare Retail Pharmacy Network
Read the comments (171 KB PDF)
340-B Drug Pricing at Children's Hospitals (September 7, 2007)
Comments on Notice Regarding the 340B Pricing Program; Children's Hospitals
Read the comments (209 KB PDF)
GSA Interim Final Rule (April 2, 2007)
Comments regarding purchasing by state and local governments through Federal Supply Schedules.
Read the comments (106 KB PDF)
340B Drug Pricing Program-Contract Pharmacy Services (March 13, 2007)
Comments on the HRSA Notice
Read the comments (114 KB PDF)
Section 602 of the Veterans Health Care Act of 1992; Definition of Patient (March 13, 2007)
Comments on the HRSA Notice
Read the comments (138 KB PDF)
Medicare Modernization Act (MMA) of 2003:
BIO's comments to AHRQ
BIO's comments to AHRQ regarding the Guide to Conducting Comparative Effectiveness Reviews (November 7, 2007)
Read the comments (208 KB PDF)
BIO's comments to AHRQ
BIO's comments regarding the Effectiveness and Off-Label Use of Recombinant Factor VIIa (October 26, 2007)
Read the comments (197 KB PDF)
BIO's comments to AHRQ
BIO's comments regarding the Medicare Prescription Drug, Improvement, and Modernization Act of 2003; Section 1013: Identification of Priority Topics for Effective Health Care Research (March 1, 2006)
Read the comments (116 KB PDF)
BIO Press Release on Passage of the MMA
Medicare Drug Coverage Will Expand Access to Biotech Products (November 25, 2003)
Read Press Release
Fact Sheet on the MMA
Legislation Offers Important Coverage to Seniors While Safeguarding Innovation (November 18, 2003).
Read the Fact Sheet
MMA Legislative Text
Full Text of the Medicare Modernization Act, Medicare Prescription Drug and Modernization Act of 2003, Public Law 108-173
Full Legislative Text (1.1 MB PDF)
Medicare Archive
Older materials on this subject are available in our archive.
Browse the Archive
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