ROBERT PORTMAN

Prepared comments on the Centers for Medicare and Medicaid Services data request and access policy changes; Prepared comments on the Food and Drug Administrations Draft Guidance for Industry and Food and Drug Administration Staff-Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.

Prepared comments on the Office of the National Coordinator for Health Information Technologys and the Centers for Medicare and Medicaid Services proposed rule to enforce the information blocking provisions of the 21st Century Cures Act.

Prepared advocacy paper on clinical data registries.

Analyze the 2024 updates to the Quality Payment Program.

Prepare white paper on clinical data registries; prepare comments on the proposed rule governing information blocking; and prepare comments in response to the request for information on improving health data privacy.

Drafted comments and background materials on CMS Proposed 2024 Updates to the Quality Payment Program (CMS-1784-P); drafted letter in response to CMS Request for Information; Episode-Based Payment Model; prepared summary of CMS Transitional Coverage for Emerging Technologies Notice

Drafted letter in response to Senate Health Committee RFI on Privacy of Patient Health Data

Provided advice and counsel on various issues relating to CMS Quality Payment Program for Qualified Clinical Data Registries, access to Medicare claims data through ResDAC process, and Coverage with Evidence Development revised requirements; prepared white paper on clinician led clinical data registries to support advocacy efforts; prepared comment letter on data element list for United States Core Data for Interoperability Plus (USCDI+) Quality submitted to HHS Office of National Coordinator for Health Information Technology; prepared comments on topics for 2023 MIPS QCDR and Qualified Registry Town Hall submitted to Center for Clinical Standards and Quality;

Provided advice and counsel on various issues relating to CMS Quality Payment Program for Qualified Clinical Data Registries, access to Medicare claims data through ResDAC process, and Coverage with Evidence Development revised requirements; prepared white paper on clinician led clinical data registries to support advocacy efforts.

Provided advice and counsel and arranged meetings on various pending issues under CMS Quality Payment Program (QPP); prepared analysis of Final Physician Fee Schedule Rule; supported advocacy efforts for Section 411 of proposed Cures 2.0 legislation providing clinical data registries with access to Medicare claims data; drafted letter to Congress on CMS implementation of MACRA directive that agency provide clinical data registries with access to Medicare data for research and quality improvement purposes; drafted comments on Federal Trade Commission ANPR on Trade Regulation Rule on Commercial Surveillance and Data Security.

Provided advice and counsel on various pending issues under CMS Quality Payment Program (QPP); provided analysis and drafted comment letter on CMS Proposed Physician Fee Schedule and letter to CMS regarding measure development rules and process; supported advocacy efforts for Section 411 of proposed Cures 2.0 legislation providing clinical data registries with access to Medicare claims data.

Provided advice and counsel on various pending issues under CMS Quality Payment Program; drafted letters to CMS regarding measure development rules and process; supported advocacy efforts for Sections 309 and 411 of proposed Cures 2.0 legislation providing clinical data registries with access to Medicare claims data.

Provided advice and counsel on various pending issues under CMS Quality Payment Program; supported advocacy efforts for Sections 309 and 411 of proposed Cures 2.0 legislation providing clinical data registries with access to Medicare claims data; participated in meeting and corresponded with MedPAC on value of registries to Medicare quality payment initiatives.

Provided advice and counsel on various pending issues under CMS Quality Payment Program; supported advocacy efforts for proposed legislation providing clinical data registries with access to Medicare claims data; drafted letter to lead House sponsors (DeGette and Upton) in support of inclusion of clinical data registry access to Medicare claims data and other registry provisions in Cures 2.0 bill; drafted letter to MedPAC requesting meeting on value of registries to Medicare quality payment initiatives.

Provided advice and counsel on various pending issues under CMS Quality Payment Program; supported advocacy efforts for proposed legislation providing clinical data registries (QCDRs) with access to Medicare claims data; drafted letters to House and Senate health committee chairs to support inclusion of registry provisions in Cures 2.0 bill and to request oversight hearing of CMS implementation of Merit-Based Incentive Payment System;prepared and submitted comments on QCDR provisions CMS Proposed CY 2022 Updates to the Quality Payment Program (CMS-1751-P).

Provided advice and counsel on various pending issues under CMS Quality Payment Program; supported advocacy efforts for proposed legislation providing clinical data registries with access to Medicare claims data; drafted letters to House health committee chairs to support inclusion of registry provisions in Cures 2.0 bill and to request oversight hearing of CMS implementation of Merit-Based Incentive Payment System.

Provided advice and counsel on various pending issues under CMS Quality Payment Program; supported advocacy efforts for proposed legislation providing clinical data registries with access to Medicare claims data.

Prepared and submitted comment letter, follow-up correspondence, and background memorandum on Qualified Payment Program provisions of 2021 Proposed Physician Payment Fee Schedule relating to Qualified Clinical Data Registries and Qualified Registries. Prepared draft legislation on access to Medicare claims data for clinician-led clinical data registries.

Prepared and submitted comment letter and background memorandum on Qualified Payment Program provisions of 2021 Proposed Physician Payment Fee Schedule relating to Qualified Clinical Data Registries and Qualified Registries. Prepared outline of draft legislation on access to Medicare claims data for clinician-led clinical data registries.

Prepared and submitted letters and emails to Centers for Medicare and Medicaid Services regarding issues related to Qualified Clinical Data Registries under the MIPS Program. Drafted letter to Representatives DeGette and Upton regarding request for comments on Cures Act 2.0 relating to clinical data registries' access to Medicare Claims Data.

Prepared and submitted letters to and participated in conference calls with Centers for Medicare and Medicaid Services regarding issues related to Qualified Clinical Data Registries under the MIPS Program.

Prepared and filed comments on CMS NPRM on FY2020 Medicare Physician Fee Schedule regarding issues related to Qualified Clinical Data Registries under the MIPS Program.

Prepared and submitted letters to and participated in conference calls with Centers for Medicare and Medicaid Services regarding issues related to Qualified Clinical Data Registries under the MIPS Program.

Prepared and filed comments on CMS NPRM on FY2020 Medicare Physician Fee Schedule regarding issues related to Qualified Clinical Data Registries under the MIPS Program.

Prepared and filed comments on Office National Coordinator RFI and NPRM on information blocking and interoperability issues

Prepared and filed comments on CMS NPRM on interoperability and information blocking.

Prepared background materials for and participated in meetings with QPP/CMS staff re Qualified Clinical Data Registry measures issues. Prepared comments on CMS NPRM on interoperability and information blocking.

Prepared comments on Office National Coordinator RFI and NPRM on information blocking and interoperability issues; prepared comments on HHS Office of Civil Rights RFI on HIPAA issues.

Follow-up letters and meetings with CMS and House and Senate Committee staff regarding provisions of CMS-1693-P - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019 relating to Qualified Clinical Data Registry measure issues. Drafted comments on Re: HHS-ONC-2018-022 - Request for Information Regarding the 21st Century Cures Act Electronic Health Reporting Program.

Drafted comments on CMS-1693-P - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program; met with CMS staff regarding same.

Drafted correspondence and participated in meeting with Office of National Coordinator of Health Information Technology and Office of Inspector General regarding interoperability and information blocking relating to flow of data from electronic health record vendors and clinical data registries under the 21st Century Cures Act.

Drafted comments on CMS-1694-P - Medicare Programs: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims

Drafted correspondence and participated in meeting with Office of National Coordinator of Health Information Technology and Office of Inspector General regarding interoperability and information blocking relating to flow of data from electronic health record vendors and clinical data registries under the 21st Century Cures Act.

Drafted correspondence and participated in meeting with Centers for Medicare and Medicaid Services Quality Payment Program team regarding issues relating to the development of quality measures by Qualified Clinical Data Registries under the Merit-Based Incentive Payment System.

Drafted correspondence and participated in meetings with CMS officials regarding self-nomination and measure approval processes for QCDRs under the Physician Quality Reporting System and the new Merit-Based Incentive Payment System. Drafted and filed comments on Quality Payment Program proposed and final 2018 updates.

Drafted correspondence and participated in meetings with CMS officials regarding self-nomination and measure approval processes for QCDRs under the Physician Quality Reporting System and the new Merit-Based Incentive Payment System. Drafted and filed comments on Quality Payment Program proposed 2018 updates.

Meetings with officials from various Centers for Medicare and Medicaid Services agencies regarding clinical data registry access to Medicare claims data and follow-up correspondence.

Background work for Coalition advocacy efforts with Centers for Medicare and Medicaid Services (CMS)regarding implementation of Section 105(b) of the Medicare Access and CHIP Reauthorization Act of 2015 regarding Qualified Clinical Data Registry (QCDR) access to Medicare data. Met with various CMS officials regarding same. Drafted correspondence and participated in meetings with CMS officials regarding self-nomination and measure approval processes for QCDRs under the Physician Quality Reporting System and the new Merit-Based Incentive Payment System.

Meeting and follow-up activity with various sub-agencies within the Centers for Medicare and Medicaid Services regarding options for registry access to Medicare claims data for quality improvement and research purposes.

Prepared letter to HHS Office of Human Research Protections regarding Final Rule on changes to the Federal Policy for the Protection of Human Subjects. 82 Fed. Reg. 7149(Jan. 19,2017).

Background work for Coalition advocacy efforts with Centers for Medicare and Medicaid Services regarding implementation of Section 105(b) of the Medicare Access and CHIP Reauthorization Act of 2015 regarding Qualified Clinical Data Registry access to Medicare data.

Draft letters to congressional committees with health care jurisdiction in support of registry-related provisions in HR 6, 21st Century Cures Act. Prepared comments for Coalition on CMS Medicare Access and CHIP Reauthorization Act (MACRA) final rule as it applies to registries; prepared letter to CMS re qualified clinical data registry performance measure consolidation issue.

Prepared comments for Coalition on CMS Medicare Access and CHIP Reauthorization Act (MACRA) final rule as it applies to registries; prepared letter to CMS re qualified clinical data registry performance measure consolidation issue.

Prepared Coalition letter to Centers for Medicare and Medicaid Services on access to Medicare data by qualified clinical data registries under Final Rule for Qualified Entities; prepared background materials for same.

Prepared Coalition comments on NPRM issued by Centers for Medicare and Medicaid Services (CMS)regarding MACRA provisions affecting qualified clinical data registries (QCDRs); worked on draft bill to protect registry data from discovery or subpoena; drafted letter to leaders of health committees on CMS NPRM on Qualified Entities regarding MACRA Section 105(b)regarding QCDR access to Medicare claims data.

Prepared Coalition comments on NPRM issued by Centers for Medicare and Medicaid Services (CMS)regarding MACRA provisions affecting qualified clinical data registries (QCDRs); worked on draft bill to protect registry data from discovery or subpoena; drafted letter to leaders of health committees on CMS NPRM on Qualified Entities regarding MACRA Section 105(b)regarding QCDR access to Medicare claims data.

Prepared Coalition comments on Improving Health Information Technology Act (S. 2511); prepared comments for Coalition on NPRM issued by HHS Office of Human Research Protections on proposed changes to the Common Rule; prepared Coalition comments on NPRM issued by Centers for Medicare and Medicaid Services regarding Qualified Entities and access to Medicare data by Qualified Clinical Data Regstries; worked on draft bill to protect registry data from discovery or subpoena.

Prepared Coalition comments on Improving Health Information Technology Act (S. 2511); prepared comments for Coalition on NPRM issued by HHS Office of Human Research Protections on proposed changes to the Common Rule; prepared Coalition comments on NPRM issued by Centers for Medicare and Medicaid Services regarding Qualified Entities and access to Medicare data by qualified clinical data registries; worked on draft bill to protect registry data from discovery or subpoena.

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill (HR 6); prepared comments for Coalition on notice of proposed rulemaking issued by HHS Office of Human Research Protections on proposed changes to the Common Rule.

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill (HR 6).

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill (HR 6); prepared comments for Coalition on notice of proposed rulemaking issued by HHS Office of Human Research Protections on proposed changes to the Common Rule.

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill (HR 6).

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill (HR 6); prepared comments for Coalition on notice of proposed rulemaking issued by HHS Office of Human Research Protections on proposed changes to the Common Rule.

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill (HR 6); prepared comments for Coalition on notice of proposed rulemaking issued by HHS Office of Human Research Protections on proposed changes to the Common Rule.

Drafted comments on qualified clinical data registry provisions in CMS proposed Medicare physician fee schedule; communications with Congress on interoperability issues for EHRs.

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill.

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill.

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill and SGR Reform bill (Medicare Access and CHIP Reauthorization Act of 2015--HR 2); communications with relating to the Social Security Death Master File; communications with CMS regarding implementation of funding for quality measures development

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill and SGR Reform bill (Medicare Access and CHIP Reauthorization Act of 2015--HR 2); communications with relating to the Social Security Death Master File; communications with CMS regarding implementation of funding for quality measures development

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill and SGR Reform bill.

Various bills to promote use of and limit regulatory burdens on clinical data registries and qualified clinical data registries, including 21st Century Cures bill and SGR Reform bill.

ASC Sterilization Policy and Meaningful Use EMR Scribe Reimbursement

Various bills addressing policy issues affecting clinical data registries, including "Protecting the Integrity of Medicare Act of 2014"

Assisted Coalition in commenting on proposed legislation being considered by House Energy & Commerce Committee to encourage the Office of Human Research Protections to create a HIPAA exception to the Common Rule in certain circumstances (e.g., Sec. 18 of the Protecting the Integrity of Medicare Act 2014)

Assisted AJRR (as member of Physician Clinical Registry Coalition) in commenting on language in proposed legislation/bills being considered by House Energy & Commerce Committee to encourage Office of Human Research Protection to create HIPAA exception to Common Rule in certain circumstances (e.g., Sec. 18 of the Protecting the Integrity of Medicare Act 2014)

Assisted Coalition in commenting on language in proposed legislation/bills being considered by House Energy & Commerce Committee to encourage Office of Human Research Protection to create HIPAA exception to Common Rule in certain circumstances (e.g., Sec. 18 of the Protecting the Integrity of Medicare Act 2014)

Assisted in preparation of comments on CMS request for information on agency's interpretation of ACA section 2706(a) nondiscrimination provisions.

Provided information on effect of HIPAA rules and Common Rule on clinical data registries to FDA staff.

Advice re Medicare Advantage Participant Bill of Rights Act of 2014 (S2552)

Provided information to FDA on HIPAA and Common Rule Issues affecting clinical data registries.

Regulations and legislation relating to clinical data registries.

Federal regulations and other matters affect clinical data registries.

Health Care Reform; Medical Data Registries; Medicare

Health Care Reform; Medical Data Registries; Medicare

Health Care Reform; Medical Data Registries; Medicare

Various issues relating to clinical data registries, including HIPAA and Common Rule issues before the HHS Office of Civil Rights and the Office of Human Research Protections; access to the Social Security Death Master File; and the final rules on Qualified Clinical Data Registries issued by CMS.

Application of HIPAA and Common Rule to clinical data registries; proposed rule on qualified clinical data registries

HIPAA and Common Rule issues affecting clinical data registries; legal protections for registry data; federal funding for registries and registry studies/programs.

HIPAA and Common Rule issues affecting clinical data registries; legal protections for registry data; federal funding for registries and registry studies/programs.

Possible legislation to protect clinical registry data and promote registry participation

Assisted in preparing legislative proposals for protecting and promoting clinical data registries.

Review of Medical Device Patient Safety Act

Drafted comments on CMS NPRM on Release of Medicare Claims Data

Meetings with executive branch officials on interpretations of HIPAA patient privacy and Common Rule requirements for clinical data registries.

Drafted comments on CMS proposed rule for sharing Medicare physician claims information with certain qualified entities.

Medical registries

Health Care Reform; Medical Data Registries; Medicare; HIPAA; Common Rule

Health Care Reform; Medical Data Registries; Medicare; HIPAA; Common Rule

Health Care Reform; Medical Data Registries; Medicare; HIPAA; Common Rule

Red Flags Rule legislation (S. 3987)

Medicare SGR legislation

Medicare SGR legislation.

Medicare SGR Reform

Health System Reform Legislation

Health System Reform Legislation

Health System Reform Legislation

Health System Reform Legislation

Health Care Reform; Medicare physician reimbursement

Review of registry provisions of various health care reform bills; comments on AHRQ white paper on registry data

Health Care Reform Legislation

Health Care Reform; Medical Data Registries; Medicare

Health Care Reform; Medical Data Registries; Medicare

Health Care Reform; Medical Data Registries; Medicare

Health Care Reform; Medical Data Registries; Medicare

Health Care Reform; Medical Data Registries; Medicare

Health Care Reform; Medical Data Registries; Medicare

Medicare Ambulatory Surgery Center Access Act of 2009--ASC quality reporting legislation; interpretation of DMEPOS surety bond requirements

HR 2425--Medicare reimbursement for certified diabetes educators

Medicare Physician Fee Schedule

Medicare DMEPOS quality standards applicability to physicians; Ambulatory Surgery Center Access Act of 2009 quality reporting requirements.

Medicare Reform Legislation

Medicare proposed anti-markup and gainsharing rules in

Medicare reimbursement for physicians; imaging legislation

Medicare physician reimbursement

Medicare anti-markup rule

Medicare DMEPOS quality standards; applicability to physicians

Medicare proposed anti-markup and gainsharing rules in

Medicare reimbursement for physicians; imaging legislation

Medicare reimbursement issues.

Medicare reimbursement for physicians; imaging legislation

Medicare reimbursement issues.

NIH research funding for interventional radiology; physician gift disclosure legislation; comparative effectiveness legislation

Medicare reform, physician payment reform, presidential and congressional Medicare budget proposals, Medicare 'trigger' legislation, PQRI program and physician quality measure legislation, Medicare coverage of imaging procedures.

Medicare Physician Reimbursement National Institutes of Health (NIH) Funding FDA Medical Device Regulation

Medicare Physician Reimbursement National Institutes of Health (NIH) Funding FDA Medical Device Regulation

Medicare Physician Payment System, Medicare Diagnostic Imaging Coverage, and NIH Authorization and Appropriations related to pulmonary artery disease and uterine fibroids.

Medicare physician reimbursement and quality issues (S-1519)

Medicare reimbursement for Certified Diabetes Educators