Resources

Regulatory Activity

Key Legislative Developments and Activity

External Stakeholder Activity

Reports and Publications

Regulatory Activity

February 20, 2024 — PCRC Comments to FDA Re: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
January 2, 2024 — PCRC Comments in Response to 21st Century Cures Act Establishment of Disincentives for Health Care Providers that Have Committed Information Blocking Proposed Rule
September 11, 2023—PCRC Letter to CMS Re: the Proposed 2024 Updates to the Quality Payment Program
August 17, 2023—PCRC Letter to CMS Re: Episode-Based Payment Models
June 30, 2023—PCRC Letter to ONC Re: Draft Data Element List for United States Core Data for Interoperability Plus (“USCDI+”) Quality
November 21, 2022—PCRC Letter to FTC Re: Trade Regulation Rule on Commercial Surveillance and Data Security
September 6, 2022—PCRC Letter to CMS Re: the Proposed 2023 Updates to the Quality Payment Program
August 5, 2022—PCRC Feedback Regarding the Measure Set Review Process
September 13, 2021—PCRC Letter to CMS Re: the Proposed 2022 Updates to the Quality Payment Program
November 10, 2020—PCRC Letter Re: Data Validation for Merit-based Incentive Payment System Performance Year 2020
October 5, 2020—PCRC Letter to CMS Re: the Proposed CY 2021 Updates to the Quality Payment Program
April 13, 2020—PCRC Letter to CMS Re. MIPS MVP Program
December 11, 2019—PCRC Letter to CMS Re. QCDR Measure Testing Requirement
October 24, 2019—PCRC Letter to CMS Re. Pre-Submission Audit Requirement
September 27, 2019—PCRC comments on CMS Physician Fee Schedule Proposed Rule
June 3, 2019 – PCRC Comments on CMS Interoperability Proposed Rule
June 3, 2019 – PCRC Comments on ONC Information Blocking Proposed Rule
February 28, 2019 - PCRC ONC EHR Reporting Program RFI Response
February 28, 2019 - PCRC Comments on CY 2019 PFS Proposed Rule
February 28, 2019 - PCRC HIPAA Request for Information Comments
February 28, 2019 - PCRC Comments on ONC Draft Burden Reduction Strategy
June 25, 2018 - Physician Clinical Registry Coalition Comments on FY 2019 IPIPS NRPM
February 8, 2018 - PCRC Letter to HHS Regarding Information Blocking by Electronic Health Record Vendors
January 1, 2018 - PRCR Comments on the CY 2018 Quality Payment Program final rule
November 20, 2017 - PCRC Letter to CMS Regarding Commercial Use of QCDR/MIPS Measures and Licensing
November 16, 2017 - CY 2018 Quality Payment Program Final Rule
August 21, 2017 - PCRC Comments on the 2018 updates to the Quality Payment Program
July 11, 2017 - PCRC Letter to CMS regarding Qualified Clinical Data Registry Issues
June 30, 2017 - CY 2018 Quality Payment Program Proposed Rule
June 22, 2017 - handout on QCDR access to Medicare claims data
February 13, 2017 - PCRC Letter to OHRP on the Federal Policy for the Protection of Human Subjects
January 19, 2017 - Final Rule on the Federal Policy for the Protection of Human Subjects

Key Legislative Developments and Activity

September 28, 2023—Coalition’s Response to Senate HELP Committee’s RFI on Health Data Privacy
October 31, 2022—PCRC Comments on Medicare Access and CHIP Reauthorization Act of 2015
December 2, 2021—PCRC Letter Supporting Sections 309 and 411 of the Cures 2.0 Act
October 6, 2021—PCRC Letter Supporting H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act of 2021
July 29, 2021—PCRC Letter Requesting a Hearing on the Implementation of MACRA (Senate)
July 28, 2021—PCRC Letter Requesting a Hearing on the Implementation of MACRA (House)
June 23, 2020 - PCRC Letter to Congress Re. Cures 2.0 Legislation
December 13, 2016 - 21st Century Cures Act

External Stakeholder Activity

National Quality Registry Network Resources
Health Insurance Portability and Accountability Act Resources
Office for Human Research Protections Resources
Quality Payment Program Resources
Council of Medical Specialty Society Resources

Research Reports and Publications

February 2016 - Council of Medical Specialty Societies Clinical Data Registry Primer
February 2015 - Guidance on Legal Challenges and Regulatory Obligations for Clinical Data Registries
Registries for Evaluating Patient Outcomes: A User’s Guide