Legislative Update

COVID-19

Summary

Status

S. 3489

Would establish or continue a multidisciplinary research program to advance the discovery and preclinical development of medical products for priority virus families and other viral pathogens with a significant potential to cause a pandemic, and for other purposes.

Referred to the Committee on Health, Education, Labor, and Pensions on Jan. 12.

H.R. 6321

Would  require the head of each Federal agency, within 100 calendar days, to complete all pending Freedom of Information Act requests related to a drug or medical device to prevent, diagnose, mitigate, or treat COVID-19, gain-of-function or potential pandemic pathogen research, or a policy, rule, or standard requiring COVID-19 vaccination of individuals, and for other purposes.

Referred to the Committee on Oversight and Reform, and to the Committee on Appropriations on Dec. 16. 

FDA Funding

Summary

Status

S. 4348

A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.

Referred to the Committee on Health, Education, Labor, and Pensions on May 26.

H.R. 7667

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.

Received in the Senate on June 9.

H.R. 6119 — Further Extending Government Funding Act

Makes further continuing appropriations for the fiscal year ending September 30, 2022, and for other purposes.

Signed into law by President Biden on Dec. 3.

Device Supply

Summary

Status

S. 3834

Would strengthen medical device supply chains.

Referred to the Committee on Health, Education, Labor, and Pensions on March 14.

S. 3496 — Promoting ACCESS to Diagnostics Act

Would improve research and development of medical countermeasures for novel pathogens.

Referred to the Committee on Health, Education, Labor, and Pensions on Jan. 13.

S. 3477 — PREVENT Medical Device Shortages Act of 2022

Would improve the program for reporting on device shortages.

Referred to the Committee on Health, Education, Labor, and Pensions on Jan. 11.

S. 3416

Would expand the enforcement authority of the Food and Drug Administration with respect to counterfeit devices.

Referred to the Committee on Health, Education, Labor, and Pensions on Dec. 16.

S. 3395 —Medical Device Integrity Act

Would amend the Federal Food, Drug, and Cosmetic Act with respect to records and other information inspections.

Referred to the Committee on Health, Education, Labor, and Pensions on Dec. 14.

H.R. 6202

Would amend titles XI and XVIII of the Social Security Act to establish requirements for the provision of certain high-cost durable medical equipment and laboratory testing; to extend and expand access to telehealth services; and for other purposes.

Referred to the Committee on Energy and Commerce, to the Committee on Ways and Means on Dec. 9.

H.R. 3635 — Strengthening America’s Strategic National Stockpile Act of 2021

Would replenish the national stockpile of devices and other medical products for use in national emergencies.

Passed in the House on Oct. 21.

H.R. 5555 — MADE HERE Act

Would establish a domestic manufacturing cluster program, and for other purposes.

Referred to the House Committee on Energy and Commerce, and the Committees on Science, Space and Technology, and Armed Services on Oct. 12.

S. 2304

Would provide Federal support for nonprofit generic and essential medicine and device manufacturers to increase the availability of drugs and devices in order to reduce drug or device shortages and drug and device costs.

Referred to the Senate Finance Committee on June 24.

Device R&D

Summary

Status

H.R. 5585 — Advanced Research Project Agency–Health Act

Would establish the Advanced Research Projects Agency–Health, and for other purposes.

Placed on Union Calendar on June 13.

H.R. 5566 — FORWARD Act of 2021

Would support fungal disease research, incentivize fungal vaccine development, discover new antifungal therapies and diagnostics, and for other purposes.

Referred to the House Committee on Energy and Commerce on Oct. 12.

Reimbursement

Summary

Status

H.R. 6848

Would provide for a Medicare demonstration project to evaluate the fiscal impact of covering low vision devices as durable medical equipment under part B of the Medicare program.

Referred to the Committee on Energy and Commerce, and to the Committee on Ways and Means on Feb. 25.

H.R. 5331 — Patient Access to ESRD New Innovative Devices Act

Would require the Centers for Medicare & Medicaid Services (CMS) to provide a certain payment adjustment under the Medicare end-stage renal disease (ESRD) prospective payment system. Specifically, the CMS must provide for a three-year temporary add-on payment adjustment for new medical devices used to diagnose, treat, or manage ESRD. (CMS regulations currently provide a two-year temporary add-on payment adjustment.)

Referred to the Committee on Energy and Commerce, and to the Committee on Ways and Means on Sept. 22.

H.R.4479 — Facilitating Innovative Nuclear Diagnostics Act of 2021

Would establish separate payment requirements for diagnostic 
radiopharmaceuticals under the Medicare prospective payment system for hospital outpatient department services. The bill's requirements apply to diagnostic 
radiopharmaceuticals that have an average daily cost of $500 or more in 2022 and as adjusted based on a specified fee schedule factor in each year thereafter.

Referred to the Committee on Energy and Commerce, and to the Committee on Ways and Means on July 16.

S. 2609 — Facilitating Innovative Nuclear Diagnostics Act of 2021

Would establish separate payment requirements for diagnostic 
radiopharmaceuticals under the Medicare prospective payment system for hospital outpatient department services. The bill's requirements apply to diagnostic 
radiopharmaceuticals that have an average daily cost of $500 or more in 2022 and as adjusted based on a specified fee schedule factor in each year thereafter.

Referred to the Committee on Finance on Aug. 4.