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BIO Comments on Proposed Section 382(h) Regulations

Nov 13 2019
The Biotechnology Innovation Organization provided comments to the Treasury Department and Internal Revenue Service on proposed regulations under Section 382 with respect to the built-in gain and built-in loss rules of Section 382(h), as generally requested in the preamble to the proposed regulations.

BIO Comments on SEC Proposal to Amend the Accelerated Filer and Large Accelerated Filer Definitions

Nov 11 2019
The Biotechnology Innovation Organization provided comments to the Securities and Exchange Commission on File No. S7-06-19, its proposal to amend the Accelerated Filer and Large Accelerated Filer definitions.

BIO Commends the Introduction of the Helping Startups Continue to Grow Act

Nov 8 2019
BIO supports the “Helping Startups Continue to Grow Act” which extends the exemption afforded to Emerging Growth Companies under the JOBS Act from certain executive compensation, financial, and other disclosure requirements for an additional five years.

State Biotech Associations Warn Part D Redesign Puts New Treatments for Patients at Risk

Nov 4 2019
In a letter to Chairman Grassley (R-IA) and Ranking Member Wyden (D-OR), the leaders of the Senate Finance Committee, state biotech associations warn that the Committee’s proposed redesign of Medicare Part D puts new, innovative treatments for patients at risk.

BIO Comments from Stephen Rapundalo (MichBio) on 2020 RFS SRE Public Hearing

Oct 31 2019
I am appearing on behalf of the Biotechnology Innovation Organization (BIO). BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations.

BIO Submits Comments to the House Energy and Commerce Hearing on "Protecting the RFS: The Trump Administration's Abuse of Secret Waivers"

Oct 31 2019
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the to the United States House of Representatives Committee on Energy and Commerce Subcommittee on Environment and Climate Change hearing, "Protecting the RFS: The Trump Administration's Abuse of Secret Waivers."

BIO Testimony to the House Energy and Commerce Subcommittee on Environment and Climate Change: “Building a 100 Percent Clean Economy”

Oct 24 2019
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the to the United States House of Representatives Committee on Energy and Commerce Subcommittee on Environment and Climate Change hearing on “Building a 100 Percent Clean Economy: Solutions for Planes, Trains and Everything Beyond Automobiles.” BIO applauds the Subcommittee for examining the challenges and opportunities associated with decarbonizing the U.S. transportation sector, with an emphasis on medium and heavy-duty trucks, buses, ships, aircraft, and rail.

BIO Submits Comments to the Office of Science Technology and Policy (OSTP) on the Bioeconomy

Oct 22 2019
The Biotechnology Innovation Organization (BIO) has submitted comments to the Office of Science Technology and Policy (OSTP) on the bioeconomy, explaining the critical role America’s biotechnology industry plays in feeding, fueling, and healing the world. The comments were recently highlighted by Tom DiLenge, president of BIO’s Advocacy, Law & Public Policy Division, during The White House Summit on America’s Bioeconomy, which included leaders from industry, academia, and the government.

BIO Submits Comments re: CY 2020 Medicare Physician Fee Schedule Proposed Rule

Oct 21 2019
BIO offers comments on the following areas in the proposed rule, with an emphasis on ensuring that Medicare beneficiaries have access to the full range of items and services necessary to their health: • BIO appreciates the opportunity to comment on the agency’s future consideration of bundled payments under the PFS but urges CMS to prioritize patient access to appropriate therapies and to weigh the results of other demonstrations underway rather than attempting to swiftly implement bundled payments. • BIO supports the proposal to retain more granular payments for Evaluation and Management (E/M) services, which we think will support access to appropriate care for the sickest patients. • BIO appreciates the efforts CMS is making to treat patients with opioid addiction and offers comments about the agency’s proposals in this area, again with an emphasis on ensuring patient access to appropriate care.

BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule

Oct 21 2019
On September 27, BIO submitted final comments in response to the CY 2020 Outpatient Prospective Payment System Proposed Rule. BIO members are eager to improve health care through the discovery and advancement of new therapies and thus are supportive of appropriate reimbursement in our health care system both to ensure that beneficiaries have proper access to care and to encourage investment in innovation. BIO has evaluated each of CMS's proposals to ensure that they support continued access to crucial treatments and therapies in the hospital outpatient setting for Medicare beneficiaries. We briefly describe our feedback on these proposals in more detail in the balance of the letter.