On December 2, 2021, the Physician Clinical Registry Coalition (“PCRC”) submitted a letter to Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) commending them for including Section 411 in the Cures 2.0 Act, which would ensure that clinician-led clinical data registries have meaningful access to Medicare, Medicaid, and State Children’s Health Insurance Program claims data to better track patient outcomes over time, expand their ability to assess the safety and effectiveness of medical treatments, and provide them with the information necessary to assess the cost-effectiveness of therapies.  This legislation would allow clinician-led clinical data registries to link their outcomes data with claims data in a way that would help ascertain the value of new medical technologies and therapies and assist in the development of effective alternative payment models (“APMs”).

PCRC also applauded Representatives DeGette and Upton for including Section 309 in the Cures 2.0 Act, which seeks to increase the use of real-world evidence and support the use of data from clinical care data repositories and patient registries to fulfill post-approval study requirements for products regulated by the Food and Drug Administration.

Click here to read the full letter.

The Physician Clinical Registry Coalition (“PCRC”) recently wrote to Congress requesting that the House Ways and Means and Energy and Commerce Committees and the Senate Finance and HELP Committees convene an oversight hearing (or hearings) to examine the Centers for Medicare and Medicaid Services’ (“CMS”) implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) as it relates to Qualified Clinical Data Registries (“QCDRs”) and clinician-led clinical data registries.  MACRA requires the Secretary of Health and Human Services (“Secretary”) to encourage the use of QCDRs for reporting measures under the quality performance category of the Merit-Based Incentive Payment System (“MIPS”) program.  MACRA also directs the Secretary to provide Medicare claims data to QCDRs “for purposes of linking such data with clinical outcomes data and performing risk-adjusted, scientifically valid analyses and research to support quality improvement or patient safety.”  Over recent years, however, CMS has established policies that contravene the language and intent of MACRA, including policies that disincentivize meaningful specialty measures.  Therefore, PCRC urged the aforementioned Committees to hold a hearing (or hearings) to examine CMS’s MACRA policies concerning measure testing, data validation requirements, access to claims data, harmonization, topped out measures, credit/incentivization for clinical data and measure testing participation, cooperative agreements, and the MIPS Value Pathway program.

Click here to read the letter to the House Ways and Means and Energy and Commerce Committees.

Click here to read the letter to the Senate Finance and HELP Committees.

In response to the released discussion draft of the Cures 2.0 legislation, the Physician Clinical Registry Coalition (“PCRC”) submitted a letter to Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) on July 9, 2021, offering recommendations for legislative reform to include in the Cures 2.0 package.  Specifically, PCRC requested that Cures 2.0 include language guaranteeing clinician-led clinical data registries access to Medicare, Medicaid, and State Children’s Health Insurance Program (“SCHIP”) claims data for quality improvement, patient safety, and research purposes.  Such reforms would allow clinician-led clinical data registries to link their outcomes data with the Centers for Medicare and Medicaid Services’ (“CMS’s”) claims data in a way that would assist in the development of effective alternative payment models and provide a greater understanding of the real-world impact of new medical technologies and therapies across numerous patient populations.  PCRC looks forward to working with Representatives DeGette and Upton to ensure that clinician-led clinical data registries have a meaningful way to gain continuous access to Medicare, Medicaid, and SCHIP claims data.

Click here to read the full letter.

On June 23, 2020, the Physician Clinical Registry Coalition (“PCRC”) submitted a letter to Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) offering recommendations for legislative reform to include in the Cures 2.0 package.  In response to the published Cures 2.0 concept paper, PCRC requested that Cures 2.0 include language guaranteeing clinician-led clinical data registries access to Medicare claims data for quality improvement, patient safety, and research purposes.  PCRC also urged that Medicare claims data be readily available to clinician-led clinical data registries through the Fast Healthcare Interoperability Resources-based application programming interface and that the Centers for Medicare and Medicaid Services (“CMS”) be required to collect Unique Device Identifiers and share that information with clinician-led clinical data registries.  Such reforms would allow clinician-led clinical data registries to link their outcomes data with CMS claims data in a way that would assist in the development of effective alternative payment models and provide a greater understanding of the real-world impact of new medical technologies and therapies across numerous patient populations.  PCRC looks forward to working with Representatives DeGette and Upton to ensure that clinician-led clinical data registries have a meaningful way to gain continuous access to Medicare claims data.

Click here to read the full letter.