The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ (CMS’s) CY2020 Revisions to Payment Policies under the Physician Fee Schedule (PFS) and Other Changes to Part B Payment Policies (“Proposed Rule”).
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’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions. BIO membership includes biologics and vaccine manufacturers and developers who have worked closely with stakeholders across the spectrum, including the public health and advocacy communities, to support policies that help ensure access to innovative and life-saving medicines and vaccines for all individuals.
We offer 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.
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
Dear Administrator Verma:
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment
on the Center for Medicare and Medicaid Services’ (CMS’s) CY2020 Revisions to Payment
Policies under the Physician Fee Schedule (PFS) and Other Changes to Part B Payment
Policies (“Proposed Rule”).
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’s members develop medical products and
technologies to treat patients afflicted with serious diseases, to delay the onset of these
diseases, or to prevent them in the first place. In that way, our members’ novel
therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also
have reduced healthcare expenditures due to fewer physician office visits, hospitalizations,
and surgical interventions. BIO membership includes biologics and vaccine manufacturers
and developers who have worked closely with stakeholders across the spectrum, including
the public health and advocacy communities, to support policies that help ensure access to
innovative and life-saving medicines and vaccines for all individuals.
We offer 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.