CALIFORNIA LIFE SCIENCES for CALIFORNIA LIFE SCIENCES

Trade (domestic/foreign) TRD

Oppose proposals to reduce data exclusivity.

Contacted: Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Natl Institute of Standards & Technology (NIST); SENATE

Defense DEF

Oppose domestic manufacturing/procurement mandates in NDAA for pharmaceutical products, APIs, & medical devices.

Contacted: Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Natl Institute of Standards & Technology (NIST); HOUSE OF REPRESENTATIVES; SENATE

Disaster Planning/Emergencies DIS

Support exemptions from California's COVID-19 stay-at-home order for the life sciences community.

Contacted: Natl Institute of Standards & Technology (NIST); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); SENATE

Budget/Appropriations BUD

Labor/HHS/Ed Appropriations: NIH, antimicrobial resistance, biodefense/pandemic, CDC, science/math education, and strategic stockpile funding and preparation; Coronavirus funding and response. FDA Appropriations; PTO Appropriations.

Contacted: Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Natl Institute of Standards & Technology (NIST); SENATE

Medical/Disease Research/Clinical Labs MED

Support NIH research funding. Support implementation of 21st Century Cures Act.

Contacted: Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); SENATE; Natl Institute of Standards & Technology (NIST); HOUSE OF REPRESENTATIVES

Taxation/Internal Revenue Code TAX

Support Research & Development and NOL tax incentives.

Contacted: Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); SENATE; Natl Institute of Standards & Technology (NIST); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES

Copyright/Patent/Trademark CPT

Address concerns with provisions of patent litigation reform, including inter partes review. Support STRONGER Patents Act. Oppose "march-in" rights and "compulsory licensing" proposals. Support transferable exclusivity extensions to incentivize novel antibiotic Research & Development. Support efforts to strengthen Bayh-Dole provisions.

Contacted: HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); SENATE; Natl Institute of Standards & Technology (NIST); Food & Drug Administration (FDA)

Health Issues HCR

Support FDA user fee programs and review process consistency and predictability. Support policy improvements to address antimicrobial resistance. Oppose domestic manufacturing/procurement mandates for pharmaceutical products, APIs, & medical devices. Support improvements to the Strategic National Stockpile for pandemic testing preparedness. Support public education campaign on pandemic preparedness. Support reauthorization of Rare Pediatric Disease Priority Review Voucher (RPD PRV) program. Oppose drug importation proposals.

Contacted: Centers For Medicare and Medicaid Services (CMS); SENATE; Natl Institute of Standards & Technology (NIST); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA)

Small Business SMB

Support changes to SBA's "affiliation rule." Support changes to Main Street Lending Program's eligibility criteria. Support Emerging Growth Companies (EGCs) Extension due to COVID-19.

Contacted: Centers For Medicare and Medicaid Services (CMS); SENATE; HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Natl Institute of Standards & Technology (NIST); Food & Drug Administration (FDA)

Medicare/Medicaid MMM

Address concerns with changes to Medicare Part B and Part D programs, and Hospital Outpatient Prospective Payment System. Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law. Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3. Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule, final rule implementation, and legislation. Oppose drug importation proposals. Support temporary home administration of Medicare Part B infused and injectable medicines during the COVID-19 public health emergency. Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule regarding cost-sharing assistance. Support separate reimbursement structure for novel antibiotics to incentivize Research & Development. Support Medicare coverage of remote patient monitoring services. Oppose prior authorization requirements in Medicare Advantage. Support expanded access to telehealth. Support value-based purchasing provision, but opposed line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule.

Contacted: Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Natl Institute of Standards & Technology (NIST); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 3 (117th)