Letters, Testimony & Comments

Dear Chairman Upton and Ranking Member Pitts:   We are writing to you on behalf of the Biotechnology Innovation Organization (...
April 5 2016
Dear Ms. Kemp:   The Biotechnology Innovation Organization (BIO) appreciates the opportunity to submit comments to the Health...
April 5 2016
Dear Ms. Drew:   The Biotechnology Innovation Organization (BIO) appreciates the opportunity to respond to the solicitation...
April 5 2016
Dear Captain Pedley:   The Biotechnology Innovation Organization (BIO) appreciates the opportunity to submit the following...
April 5 2016
Dear Acting Administrator Slavitt:   The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments...
April 5 2016
Dear Mr. Cavanaugh:   The Biotechnology Innovation Organization (BIO) appreciates this opportunity to comment on the Centers for...
April 5 2016
Dear Acting Administrator Slavitt:   The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments...
April 5 2016
Dear Dr. Goodrich:   The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments in response to...
April 5 2016
Ranking Member Wyden and Senator Grassley:   The Biotechnology Innovation Organization (BIO) is pleased to submit the following...
April 5 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit comments in response to the Centers for Medicare & Medicaid...
April 4 2016
RE: CMS Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive...
December 22 2015
Captain Krista M. Pedley, PharmD, M.S., USPHS, Director Office of Pharmacy Affairs Health Resources and Services Administration...
December 22 2015
The Biotechnology Industry Organization (BIO) is pleased to submit feedback in response to the U.S. Department of Health and Human...
December 22 2015
Sylvia Mathews Burwell Secretary U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C....
December 22 2015
Andrew Slavitt Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H...
December 22 2015
Andrew Slavitt Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H...
December 22 2015
Marilyn Tavenner  Administrator Centers for Medicare & Medicaid Services  Department of Health and Human Services...
December 22 2015
Sean Cavanaugh Deputy Administrator Director, Center for Medicare Centers for Medicare & Medicaid Services 7500 Security Boulevard...
December 22 2015
BIO Draft Comments in Response to the 2017 Star Ratings Update Request for Comments Note to Members: CMS requires that responses to...
December 22 2015
Re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective...
December 22 2015
Sylvia Mathews Burwell  Secretary U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C...
December 17 2015
Re: 340B Drug Pricing Program Omnibus Guidance [RIN-0906-AB08]   Dear Secretary Burwell, Acting Administrator Macrae, and...
October 30 2015
The Honorable Howard A. Shelanski Administrator Office of Information and Regulatory Affairs Office of Management and Budget 725...
October 30 2015
Dear Commander Pedley: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments in response to the...
October 30 2015
Dear Dr. Pearson:   On behalf of the Biotechnology Industry Organization (BIO), I would like to submit the following feedback...
October 14 2015
Jennifer Carver HCPCS Public Meeting Coordinator Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C5...
September 28 2015
Re: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2016 [CMS-1631-...
September 8 2015
Re:  Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting...
September 2 2015
Dear Acting Administrator Slavitt: The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for...
August 25 2015
Dear Secretary Burwell and Commander Pedley:   The Biotechnology Industry Organization (BIO) appreciates the opportunity to...
August 25 2015
The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS...
August 25 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide feedback on the American Society of Clinical...
August 25 2015
The Biotechnology Industry Organization (BIO) is pleased to provide comments in response to the May 7 Centers for Medicare and Medicaid...
May 8 2015
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments regarding the Center for Medicare and Medicaid...
January 16 2015
The Biotechnology Industry Organization (BIO) appreciates this opportunity to submit the following comments on the National Association...
January 16 2015
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments regarding the Department of Health and Human...
January 6 2015
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Patient-Centered Outcomes Research...
November 14 2014
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Patient-Centered Outcomes Research...
November 14 2014
The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services...
October 1 2014
August 29, 2014   BY ELECTRONIC DELIVERY   Sylvia M. Burwell Secretary Department of Health and Human Services...
September 2 2014
August 29, 2014   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid...
September 2 2014
August 29, 2014   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid...
September 2 2014
August 29, 2014   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid...
September 2 2014
  June 10, 2014   Jacob J. Lew Secretary, Department of the Treasury 1500 Pennsylvania Avenue, NW Washington, D.C....
June 11 2014
February 25, 2013     Marilyn Tavenner, B.S.N., M.H.A. Administrator Centers for Medicare & Medicaid Services...
March 27 2014
Dear Ms. Badrov: The Biotechnology Industry Organization (BIO) and the Illinois Biotechnology Industry Organization (iBIO) appreciate...
January 31 2014
Dear Ms. Gibson: To Whom It May Concern: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the...
January 31 2014
Re: Revision of USP Medicare Model Guidelines v6.0 for Benefit Years 2015-2017   Dear Members of the Therapeutic Information and...
November 5 2013
    September 6, 2013   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare...
September 16 2013
September 6, 2013   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid...
September 16 2013
  March 15, 2013 Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services...
August 16 2013
Joe V. Selby, M.D., M.P.H. Executive Director Patient-Centered Outcomes Research Institute 1701 Pennsylvania Ave. NW Suite 300...
August 2 2013
Louis Jacques, M.D. Director, Coverage and Analysis Group Centers for Medicare and Medicaid Services 7500 Security Boulevard...
August 2 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the "Notification of Comment Period...
July 23 2013
Dear Dr. Conway: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on Section 220.6 of the National...
July 3 2013
Re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective...
June 24 2013
  BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter, submitted Friday,...
March 1 2013
Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H....
February 21 2013
The Biotechnology Industry Organization (“BIO”) is pleased to submit the following comments in response to “Proposed...
December 21 2012
          The Biotechnology Industry Organization (BIO) is pleased to submit the following...
December 21 2012
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical...
October 4 2012
Re:  Patient-Centered Outcomes Research Institute (PCORI) Draft Methodology Report Dear Dr. Selby: The Biotechnology Industry...
September 13 2012
Re:      Hospital Outpatient Prospective and Ambulatory Surgical Center Payment Systems and Quality Reporting...
September 3 2012
Re:  Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule; Proposed Rule [CMS-1590-P] Dear Acting...
September 3 2012
Dear Mr. Reed: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Draft Methodology for...
August 16 2012
Marilyn Tavenner Acting CMS Administrator Centers for Medicare and Medicaid Services     Dear Acting Administrator...
August 14 2012
Re:      Proposed Project: Enrollment and Recertification of Entities in the 340B Drug Pricing Program (OMB No....
May 17 2012
  The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid...
May 17 2012
BIO Public Statement Medicare Evidence Development & Coverage Advisory Committee Meeting Evidentiary Characteristics for Coverage...
May 15 2012
Re:      CMS-2345-P (Proposed Rule, Medicaid Program; Covered Outpatient Drugs) Dear Ms. Tavenner: The...
April 1 2012
RE: Patient-Centered Outcomes Research Institute (PCORI) Draft National Priorities and Research Agenda Dear Dr. Selby:   ...
March 14 2012
Re: Draft 2013 Call Letter Dear Mr. Blum and Mr. Spitalnic: The Biotechnology Industry Organization (BIO) appreciates this...
March 2 2012
BIO Public Statement: National Patient and Stakeholder Dialogue Thank you for the opportunity to present comments on behalf...
February 27 2012
Centers for Medicare & Medicaid Services  Re:  Docket No. CMS-5060-P:  Proposed rule implementing Section 6002 of...
February 17 2012
Re:    Draft Framework for the National Plan to Address Alzheimer's Disease Dear Ms. Glied:     ...
February 8 2012
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Department of Health and Human Services...
January 31 2012
Re: Request for Comments Regarding Enhancements to the Part C and Part D Plan Ratings The Biotechnology Industry Organization (BIO)...
January 20 2012
Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for...
November 23 2011
Thank you for the opportunity to present comments on behalf of the innovative biotechnology industry which is working to prevent, treat,...
October 25 2011
  Re:  Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient...
September 30 2011
RE:      Comments on Proposed Definition of PCORI  1.   Does the definition place appropriate...
September 2 2011
RE:     June 29, 2011 Memorandum on Proposed Changes to the Medicare Coverage Gap Discount Program – Low-Volume...
August 1 2011
BIO’s comments addressed maters such as HRSA’s application of the exclusion, operational concerns arising from the proposed...
July 19 2011
Re: Medicare Program; Medicare Shared Saving Program: Accountable Care Organizations; Proposed Rule [CMS-1345-P] Dear Dr. Berwick:...
June 6 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9] Dear Mr. Commissioner: The Biotechnology Industry...
April 29 2011
The Biotechnology Industry Organization (BIO) thanks the Institute of Medicine (IOM) for the opportunity to comment on the successes and...
April 28 2011
RE: Medicare Coverage Gap Discount Program Appeals Guidance The Biotechnology Industry Organization (BIO) appreciates this opportunity...
April 22 2011
Re: Comments on Section 6002 of the Affordable Care Act Dear Sir or Madam: BIO appreciates the opportunity to comment on the...
April 7 2011
Re: Draft 2012 Part D Call Letter Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) appreciates this...
March 4 2011
HHS-OS-2010-002: Request for Information Regarding Value-based Insurance Design in Connection with Preventive Care Benefits The...
March 1 2011
RE: Draft Update to Chapter 4 of the Medicare Managed Care Manual Dear Ms. Moon: The Biotechnology Industry Organization (BIO) is...
February 24 2011
Re: Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year...
January 11 2011
Re: Parallel Review of Medical Products [FDA-2010-N-0308] Dear Dr. Berwick and Dr. Hamburg: The Biotechnology Industry Organization (...
December 16 2010
Institute of Medicine Essential Health Benefits BIO Comments 1. What is your interpretation of the word “essential” in...
December 6 2010
Re: Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program [CMS-1345-...
December 3 2010
Re: Comments on Dispute Resolution Dear Ms. Taylor: The Biotechnology Industry Organization (“BIO”) appreciates this...
November 19 2010
Re: Comments on the Civil Monetary Penalties Dear Mr. Lang: The Biotechnology Industry Organization (BIO) appreciates this...
November 19 2010
Re: Docket No. Docket No. FDA-2010-N-0506, Request for Comments on the Food and Drug Administration Fiscal Year 2011-2015 Strategic...
November 1 2010
Re: Docket No. FDA-2010-D-0246: Draft Guidance for Industry on Residual Drug in Transdermal and Related Drug Delivery Systems Dear Sir...
November 1 2010
Re: Docket No. FDA–2010–N–0437, Development and Distribution of Patient Medication Information for Prescription Drugs...
October 29 2010
BIO submitted comments on FDA’s "Development and Distribution of Patient Medication Information for Prescription Drugs."...
October 29 2010
Dear Ms. Maloy, As President and CEO of the Biotechnology Industry Organization (BIO) and on behalf of our more than 1,100...
September 30 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes...
September 23 2010
Re: Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: Inclusion of TRICARE Retail Pharmacy Program in...
September 23 2010
Re: Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient...
September 17 2010
BIO suggests the proposed guidance address dose finding, additive or synergistic efficacy, additive or synergistic safety, drug...
September 7 2010
BIO is pleased that CMS proposes to reimburse all separately payable drugs and biologicals at average sales price (ASP) plus six percent...
August 31 2010
BIO is concerned about problems in CMS methodology that continue to create instability in reimbursement for separately payable drugs and...
August 24 2010
Although BIO recognizes that preventing a significant cut in physician payment rates is largely within Congress' authority, we urge...
August 24 2010
BIO recently submitted written comments to the FDA on the impact of Risk Evaluation and Mitigation Strategies (REMS) on the healthcare...
August 13 2010
BIO encourages ASPE to proceed with caution on the creation of an inventory and raises some methodological and structural considerations.
August 9 2010
BIO is concerned about CMS’ decision to open an NCA on a recently-approved therapy because it could establish a precedent that...
July 30 2010
BIO comments on the Medicare Coverage Gap Discount Program Draft Third Party Administrator Agreement (TPA Agreement) and the Draft Data...
July 16 2010
Re: Medicare Coverage Gap Discount Program Model Manufacturer Agreement – [CMS-4151-NC] RIN 0938-AQ04 Dear Administrator Tavenner...
June 21 2010
BIO supports the coverage gap discount program and believes that it will increase patient access to life-saving and life enhancing...
May 14 2010
Re: Draft 2011 Part D Call Letter Dear Acting Administrator Frizzera: The Biotechnology Industry Organization (BIO) appreciates this...
March 5 2010
Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on...
November 23 2009
BIO Comments to CMS regarding Proposed Rule CMS-1413-P
August 31 2009
BIO Comments to CMS regarding Proposed Rule CMS-1414-P
August 31 2009
BIO is the largest trade organization to serve and represent the biotechnology industry in the United States and around the globe. BIO...
April 13 2009
BIO’s Comments on the Provisional Appointments for the Institute of Medicine Committee on Comparative Effectiveness Research...
April 2 2009
Re: CMS-4138-IFC4 (Medicare Program; Medicare Advantage and Prescription Drug Programs MIPPA Drug Formulary and Protected Classes...
March 17 2009
Re: Request for Comments regarding the July 30, 2008 CMS Posting of Potential National Coverage Decision Topics Dear Dr. Phurrough:...
September 26 2008
Re: CMS-1404-P (Medicare Program; Proposed Changes to the Hospital Outpatient Prospective Payment System and CY 2009 Payment Rates;...
September 2 2008
  Re: Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009;...
August 29 2008
Re: Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates [CMS-1390-P]...
June 13 2008
BIO's comments to CMS regarding the tracking sheet and prospective data collection requirements
May 9 2008
Re: Medicare Program; Town Hall Meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC)—April 30,...
April 3 2008
Re: Adding Compendia for the Purposes of Making Medicare Coverage Determinations Dear Ms. Tillman: The Biotechnology Industry...
March 14 2008
BIO's testimony before the Advisory Panel on Ambulatory Payment Classifications regarding the policies the CMS has adopted and is...
March 7 2008
Re: Comments on Draft CY 2009 Call Letter Dear Dr. Tudor: The Biotechnology Industry Organization (BIO) appreciates this opportunity to...
January 30 2008
Re: CMS-1392-FC (Medicare Program; Changes to the Hospital Outpatient Prospective Payment System and CY 2008 Payment Rates) Dear...
January 28 2008
Re: CMS–10224 (Agency Information Collection Activities: Proposed Collection; Comment Request; HCPCS Level II Code Modification...
January 10 2008
Re: CMS-2238-P (Medicaid Program; Prescription Drugs) Dear Acting Administrator Weems: The Biotechnology Industry Organization (BIO)...
December 21 2007
BIO's comments on proposed changes to the 2010 HCPCS Level II Modification Process
December 10 2007
Re: Comments on the USP Draft Medicare Model Guidelines Dear Dr. Perfetto: The Biotechnology Industry Organization (BIO) appreciates...
December 6 2007
BIO's comments to AHRQ regarding the Guide to Conducting Comparative Effectiveness Reviews
November 7 2007
BIO's comments regarding the Effectiveness and Off-Label Use of Recombinant Factor VIIa
October 26 2007
BIO's comments on proposed changes to the 2009 HCPCS Level II Modification Process
September 18 2007
BIO's comments on the Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC)
September 17 2007
BIO's comments to CMS regarding proposed changes
September 14 2007
Comments on Notice Regarding the 340B Pricing Program; Children's Hospitals
September 7 2007
BIO's comments on
August 31 2007
BIO letter to CMS
July 24 2007
Re: Proposed Decision Memorandum for Erythropoiesis Stimulating Agents (ESAs) for Non-Renal Disease Indications (CAG-00383N) Dear Dr....
June 13 2007
Dear Acting Administrator Norwalk: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers...
June 13 2007
BIO's presentation to MCAC
May 10 2007
Regarding their letter to Pharmaceutical Manufacturers on the definition of AMP used to calculate 340B ceiling prices.
April 16 2007
BIO letter to Senators Baucus and Grassley
April 11 2007
BIO's Comments.
April 3 2007
Comments regarding purchasing by state and local governments through Federal Supply Schedules.
April 2 2007
Comments on the HRSA Notice
March 13 2007
Comments on the HRSA Notice
March 13 2007
Comments regarding the treatment of prescription drugs under the Medicaid Drug Rebate Program
February 20 2007
BIO's Comments on the Town Hall Meeting
February 6 2007
Survey Finds Private Sector Negotiations Provide Both Savings and Choice, Making Government Interference Unnecessary.
February 1 2007
BIO's testimony before the Advisory Panel on Ambulatory Payment Classification Groups
February 1 2007
Comments to agency's Proposed Rule regarding collection of and access to claims data under Medicare Part D.
December 18 2006
BIO's presentation to MCAC
December 13 2006
BIO's comments
December 8 2006
BIO's comments to CMS including list of recommended journals to be added
November 22 2006
BIO's letter to CMS Acting Administrator Leslie Norwalk
November 16 2006
BIO's Comments
October 31 2006
BIO's Comments to CMS
October 10 2006
BIO's Comments to CMS
October 10 2006
From the Moran Company
October 6 2006
Comments to CMS on the draft.
September 26 2006
Comments to CMS
September 18 2006
BIO's comments regarding the CMS proposed notice on the five-year review of work relative value units (RVUs) and proposed changes to...
August 21 2006
The Biotechnology Industry Organization (BIO) appreciates this opportunity to testify before the Advisory Panel on Ambulatory Payment...
August 18 2006
BIO's comments on the CMS' Tracking Sheet regarding the development of a Clinical Research Policy (CRP) as a reconsideration of...
August 9 2006
On August 1, 2006 the Centers for Medicare and Medicaid Services (CMS) released the fiscal year (FY) 2007 hospital inpatient prospective...
August 8 2006
BIO's comments regarding the Medicare Prescription Drug, Improvement, and Modernization Act of 2003; Section 1013: Identification of...
March 1 2006
The Biotechnology Industry Organization (BIO) appreciates this opportunity to testify before the Advisory Panel on Ambulatory Payment...
March 1 2006
BIO's Comments on Authoritative Drug Compendia That May Be Used in Determining Medically Accepted Indications of Drugs and...
February 27 2006
BIO's Comments on the Centers for Medicare and Medicaid Servicesí interim final rule regarding exclusion of vendor purchases...
January 20 2006
To United States Pharmacopeia
January 6 2006
BIO's Comments on the Centers for Medicare and Medicaid Services' final rule regarding revisions to payment policies under the...
December 23 2005
BIOís comments on Noridian Admistrative Services draft LCD regarding drugs and their covered diagnosis.
December 14 2005
BIO's comments on the Office of Inspector General's proposed Rule regarding new Safe Harbors for e-prescribing
December 13 2005
42 CFR 414.804 (CMS-10110)
October 14 2005
Dr. Hambrick and members of the APC Advisory Panel, thank you for the opportunity to be here today. Unfortunately, Terry Ghio was unable...
February 23 2005
BIO's comments on the Proposed Bulletin for Good Guidance Practices released by the Office of Management and Budget (OMB).
January 9 2005
BIO's comments on the Centers for Medicare and Medicaid Servicesí final rule regarding revisions to the hospital outpatient...
January 9 2005
As posted on CMS's Web site on December 3, 2004
December 23 2004
Relating to CMS' proposed rule revisions from the Federal Register CMS-1427-P, August 16, 2004
October 8 2004
Federal Register CMS-4068-P, August 3, 2004
October 4 2004
Relating to CMS's proposed rule revisions
September 24 2004
Under the Medicare physician fee schedule.
September 24 2004
Comments to United States Pharmacopeia's draft Medicare Prescription Drug Benefit Model Guidelines
September 17 2004
The Biotechnology Industry Organization (BIO) appreciates this opportunity to testify about the hospital outpatient department...
September 2 2004
Good morning, my name is Jayson Slotnik and I am here on behalf of the Biotechnology Industry Organization (BIO), the trade association...
August 27 2004
Executive Summary The Biotechnology Industry Organization (BIO) supports amendment of the current reexamination authority to enhance patent...
May 10 2001

Letters, Testimony & Comments

April 21 2016
We share the Department’s goals of improving population health, improving individual health outcomes, and rewarding high value care delivery. While the goals of the DSRIP program focus more specifically on decreasing unnecessary hospitalizations and increasing care coordination, the current structure of the Roadmap may allow participating MCOs and Performing Provider Systems (PPS)...
April 5 2016
We write to articulate our firm belief that facilities and organizations prohibited by BBA section 603 from billing Medicare as Hospital Outpatient Departments (HOPDs), starting in 2017, should be prohibited from being listed as reimbursable on hospitals’ Medicare cost reports and be similarly prohibited from participating in the 340B Program.
April 5 2016
Last year, Maryland enacted legislation that purports to expand 340B eligibility with respect to certain outpatient facilities in the state. We write to reinforce the need to ensure that these facilities meet all applicable federal requirements with respect to 340B eligibility before they are able to obtain discounts through the program.
April 5 2016
Since the OIG last revised the discount safe harbor to the AKS in 1999, for example, the U.S. healthcare marketplace has undergone significant changes, including not only the creation of the Medicare Part D benefit, but also a shift away from a system based solely on fee-for-service towards one that aims to incentivize the provision of higher quality and more efficient care.
April 5 2016
BIO represents an industry devoted to discovering new treatments and ensuring patient access to them. Accordingly, we support the 340B Program as a way to improve access to therapies for indigent patients. We believe that compliance with 340B Program requirements by all parties—including manufacturers—is an important part of ensuring the sustainability of the 340B Program. To these ends, we applaud HRSA’s recent commitment and activities to enforce program oversight and compliance, including to provide further details surrounding manufacturer audits of covered entities authorized under section 340B(a)(5)(C) of the Public Health Service Act (PHSA). That said, while a number of factors make it difficult for us to evaluate HRSA’s estimated manufacturer burden for these activities with precision, we are concerned that HRSA’s Proposed ICR underestimates the time it generally takes manufacturers to complete each of the reporting activities described.

Press Releases

April 25 2016
Washington, D.C. (April 25, 2016) – The Biotechnology Innovation Organization (BIO) issued the following statement today regarding the Campaign for Sustainable Rx Pricing’s policy proposals on prescription drug prices:
March 30 2016
Washington, D.C. (March 30, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement today regarding the American College of Physicians’ policy paper on prescription drugs:
April 29 2015
Washington, D.C. (April 29, 2015) – The Biotechnology Industry Organization (BIO) today releases the following statement on the 21st Century Cures Initiative discussion draft shared by Chairman Fred Upton (R-MI), Rep. Diana DeGette (D-CO), Rep. Frank Pallone, Jr. (D-NJ), Rep. Joe Pitts (R-PA), and Rep. Gene Green (D-TX). 
May 29 2014
Many participating hospitals appear to be deviating from the program’s original intent by leveraging 340B discounts for financial gain, rather than improving patient access
March 11 2014
BIO commended the Centers for Medicare & Medicaid Services (CMS) for announcing their decision to halt movement on several proposals in their Medicare Part D draft rule.