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.
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.
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.
On July 9, 2019, the Physician Clinical Registry Coalition (Coalition), with the support of the American Society of Hematology, the American Psychiatric Association, and the American Medical Association (AMA) Cancer Caucus, submitted a letter to the AMA Board of Trustees regarding the reconsideration of Report 26-A-19, “Research Handling of De-Identified Patient Information” (Report 26).
Report 26 contains valuable information, both about various uses of de-identified clinical data and the differences between individually identifiable health information or protected health information and de-identified data. However, Report 26 calls for the imposition of unprecedented limitations on the use of wholly de-identified data. In its letter to the AMA Board of Trustees, the Coalition expressed concern that such limitations may have adverse long-term effects that will harm patients by creating barriers to accessing information that provides critical insight to care delivery and health outcomes. The Coalition emphasized that limitations on the use of wholly de-identified data run counter to the Health Insurance Portability and Accountability Act and other well-established privacy and research protection laws and will curtail improvements in quality of care. The Coalition noted that a system in which individual patients could influence the creation, use or disclosure of a de-identified data set would exceed any current legal boundaries or authorities and would threaten the viability of the clinical data registries that hold so much promise for improving the quality of care.
The Coalition also expressed concern regarding a reference in Report 26 that appears to question the propriety of “patient record licensing contracts with exclusive rights.” The Coalition believes that such licensing agreements should not automatically be cause for concern as long as they are accompanied by appropriate safeguards and accountability to prevent re-identification of de-identified data and to allow registries to continue to advance their core missions. The Coalition requested an opportunity for further dialogue to better understand the nature of the concerns that prompted that remark in Report 26.
The Coalition looks forward to working with the AMA Board of Trustees to help ensure that appropriate protections for personal health information are in place, while supporting a strong registry environment that leads to critical insights about quality and patient outcomes.
On June 3, 2019, the Physician Clinical Registry Coalition submitted comment letters on proposed rules from the Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS) related to information blocking and interoperability.
ONC’s proposed rule implements Section 4004 of the 21st Century Cures Act, which prohibits information blocking by health care providers, health IT developers, and health information networks and exchanges. In its comments, the Coalition urged ONC to address both the ability of electronic health record (EHR) vendors to exchange electronic health information, as well as the usability of the exchanged data. The Coalition expressed concern about the breadth of ONC’s proposed definitions of health information networks and health information exchanges, as these definitions appeared to be contrary to Congressional intent. The Coalition strongly urged ONC to ensure that its proposed exceptions to the information blocking prohibition be narrowly tailored. The Coalition also asked ONC to provide additional information regarding how it will effectively enforce the information blocking provision. Click here to read the full letter.
CMS’s proposed rule focuses largely on patient access to health care data and interoperability. In its comments, Coalition urged CMS to take steps to expand provider access to data in order to promote quality of care and enhance health care decision making, as well as to take steps to encourage participation in clinical data registries. Click here to read the full letter.
In both comment letters, the Coalition emphasized that registries and their participants must comply with a complex framework of laws and regulations that includes the HIPAA regulations, the Common Rule, the FTC Act, and state privacy laws and security standards. The Coalition encouraged ONC and CMS to work with the Office for Civil Rights, the Office of Human Research Protections, and the FTC to eliminate conflicts or duplication between HIPAA, the Common Rule, the FTC’s enforcement efforts, and this new regulatory scheme. The Coalition looks forward to working with each of these agencies and departments on these important issues.
On February 12, 2019, the Physician Clinical Registry Coalition submitted a comment letter to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services in response to a request for information on modifying the HIPAA Rules to improve coordinated care.
The Coalition urged OCR to ensure that any potential new requirements to disclose PHI are consistent with the Office of the National Coordinator for Health Information Technology’s (ONC) ongoing rulemaking to prohibit ‘‘information blocking,’’ as defined by the 21st Century Cures Act. The Coalition also strongly urged OCR to coordinate with the Office of Human Research Protections to eliminate conflicts or duplication between HIPAA and the Common Rule. Finally, as a part of the Coalition’s efforts to protect clinical registry data, the Coalition expressed its support for a safe harbor that protects data that identifies individual physicians and other health care providers from discovery in litigation. The Coalition hopes to work with OCR and members of Congress on this issue.
In light of this request for information and ONC’s recently released proposed rule on information blocking, the Coalition looks forward to working with OCR, ONC, and other divisions of the U.S. Department of Health and Human Services to promote information sharing and interoperability and reduce regulatory and administrative burden.
Click here to read the full letter.
On February 6, 2019, the Physician Clinical Registry Coalition participated in a “white boarding” session with officials from the Centers for Medicare and Medicaid Services (CMS), the Council for Medical Specialty Societies (CMSS), and PCPI. The session focused on improving the qualified clinical data registry (QCDR) measure review process, licensing and harmonization of QCDR measures, and other issues impacting QCDR participation in the Merit-based Incentive Payment System (MIPS).
The session came at a key time as CMS embarks on drafting the Quality Payment Program proposed rule for CY 2020. The Coalition participated in this session as a part of its ongoing dialogue with CMS about the QCDR program and QCDR participation in MIPS. The Coalition submitted a letter to CMS in December 2018 that identified many of the issues discussed in the white boarding session. The full letter is available here. The Coalition also advocated for solutions to many of these issues in its comments on the CY 2019 Physician Fee Schedule and Quality Payment Program proposed rule. The Coalition’s comments are available here.
As a result of the Coalition’s advocacy efforts on the CY 2019 Physician Fee Schedule and Quality Payment Program proposed rule, CMS decided not to adopt its proposed mandatory QCDR measure licensing requirement. The proposal would have taken away QCDRs’ ability to ensure that only qualified third parties can use their measures and that their measures are used appropriately, as well as threatened the intellectual property rights of measure owners. The Coalition applauds CMS’s decision not to adopt this proposal. The Coalition will continue to work with CMS to develop ways to preserve the intellectual property rights of QCDR measure owners, while ensuring that measures are readily available to other qualified QCDRs.
On January 28, 2019, the Physician Clinical Registry Coalition submitted comments on the Office of the National Coordinator for Health Information Technology’s (ONC) draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs.
While the Coalition appreciated ONC’s attention to reducing regulatory and administrative burden relating to the use of health information technology (Health IT) and electronic health records (EHRs), the Coalition expressed concern that ONC’s draft strategy failed to acknowledge the value of clinical data registries, particularly the important role that QCDRs and other clinical data registries play in enhancing quality improvement activities and reducing administrative burden for clinicians. The Coalition strongly urged ONC to address the burden associated with the lack of interoperability between EHRs and clinical data registries in its burden reduction strategy.
Click here to read the full letter.
On October 17, 2018, the Physician Clinical Registry Coalition submitted a comment letter to the Office of the National Coordinator for Health Information Technology (ONC) in response to a request for information on the Electronic Health Record (EHR) Reporting Program established by the 21st Century Cures Act (the Cures Act). The Cures Act requires the Secretary of the U.S. Department of Health and Human Services to develop an EHR Reporting Program and establish reporting criteria that address security, interoperability, usability and user-centered design, and conformation to certification testing, as well as other categories as appropriate, which may include those suggested in the statute.
In the interoperability category, the Coalition urged ONC to establish reporting criteria that include information about how EHRs exchange electronic health information with registries and the usability of such data. This information will assist efficient exchange of health information and allow providers and clinicians to make informed decisions about their EHR vendors. The Coalition also strongly encouraged ONC to prioritize the inclusion of the “submitting, editing, and retrieving data from registries, such as clinician-led clinical data registries” category in the EHR Reporting Program, as suggested by the Cures Act.
Click here to read the full letter.
On September 10, 2018, the Physician Clinical Registry Coalition submitted a comment letter to the Centers for Medicare & Medicaid Services (“CMS”) at the U.S. Department of Health and Human Services on the CY 2019 Physician Fee Schedule proposed rule, which included proposed changes to the Quality Payment Program.
While the Coalition supports CMS’s proposal to revise the definition of a qualified clinical data registry (“QCDR”) to require clinical expertise in medicine and quality measure development, the Coalition expressed significant concerns about other proposals related to QCDRs and the use of QCDR measures in the Merit-based Incentive Payment System (“MIPS”) program. Among other concerns, the Coalition strongly urged CMS to reject a proposal that would require QCDR measure owners to enter into license agreements with CMS as a condition of measure approval. The Coalition strongly opposes this proposal because it undermines QCDR measure ownership and investment in measure development, as well as violates the intellectual property rights of QCDRs.
The Coalition also advised CMS to reconsider its proposals or seek additional input on the self-nomination process, treatment of topped out measures, development of QCDR benchmarks, the removal of the Public Health and Clinical Data Exchange objective from the Promoting Interoperability performance category, and the facility-based measurement scoring option.
Click here to read the full letter.