Policy & Regulatory

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CARIN tirelessly works on commenting, best-practices, and writing consumer-directed exchange letters to harmonize rules across government agencies.

We are currently focused on (and anticipating) updates to: information blocking, the second version of TEFCA and patient access, and interoperability.

Submitted Public Comments

Please search below to review our recent public Documents and Filings activity. Please note CMS and ONC are subsidiary agencies to HHS.

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CMS
Best Practice
December 1, 2023
Best Practice Recommendations for HL7® FHIR® Based Deployment

CARIN is publishing a Best Practice Recommendations for HL7® FHIR® Based Deployment for how to improve the current HL7® FHIR® ecosystem to prepare the industry for implementing HL7® FHIR® at scale. We believe if followed, these best practices will dramatically improve FHIR connectivity across the country with provider, payers, and patients.

CMS
ONC
HHS
Letter
December 1, 2023
CARIN Letter to HHS on Provider Information Blocking Disincentives

The CARIN Alliance provided comment to ONC and CMS on their provider information blocking disincentive proposed rule with recommendations on its complaint submission process, applicable providers, and prioritization of enforcement activity. In our comments we provided a number of innovative ideas including a ‘complaint clearinghouse’ concept that requests ONC to allow providers and payers an option to submit complaints to an independent third-party who would aggregate those complaints and then submit them as a group. This would avoid individual providers and payers knowing which of their trading partners submitted the complaints but would also identify clear violations of information blocking to advance information sharing with providers, payers, and most importantly patients. See the link above for our full comments.

HHS
CMS
Comment
December 1, 2023
CARIN Alliance Comments on National Healthcare Directory

CARIN Alliance Comments on National Healthcare Directory

HHS
CMS
ONC
FTC
Comment
June 1, 2023
CARIN Alliance Comments on the ONC Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm

CARIN Alliance Comments on the ONC Health Data, Technology, and Interoperability: Certification Program Updates, AlgorithmTransparency, and Information Sharing NPRM

CMS
Comment
March 1, 2023
CARIN Alliance Comments on the CMS Advancing Interoperability and Improving Prior Authorization Processes NPRM (CMS-0057-P)

CARIN Alliance Comments on the CMS Advancing Interoperability and Improving Prior Authorization Processes NPRM (CMS-0057-P)

HHS
CMS
Comment
February 1, 2023
CARIN Alliance Comments on Medicare Advantage requirements for Real-time Benefit Tools

CARIN Alliance Comments on Medicare Advantage requirements for Real-time Benefit Tools

HHS
ONC
Comment
September 1, 2022
CARIN Alliance Comments on ISA 093022

CARIN Alliance Comments on ISA 093022

ONC
CMS
HHS
Comment
July 1, 2022
Comments to Recognized Coordinating Entity on the Current Draft IAS Exchange Purpose Implementation SOP

Comments to Recognized Coordinating Entity on the Current Draft IAS Exchange Purpose Implementation SOP

HHS
CMS
ONC
FTC
Comment
July 1, 2022
Comments on the RCE’s Draft IAS Provider Privacy and Security SOP

CARIN Alliance Comments to Recognized Coordinating Entity on the Current Draft IASProvider Privacy and Security Notice and Practices SOPs

HHS
OCR
Letter
July 1, 2022
Letter to OCR requesting clarification regarding Breach Notification requirements for Patient Access in a Networked Environment

Letter to OCR requesting clarification regarding Breach Notification requirements for Patient Access in a Networked Environment

HHS
ONC
Comment
April 1, 2022
CARIN Alliance Comments on Draft USCDI v3 042922 –

CARIN Alliance Comments on Draft USCDI v3 042922 –

CMS
ONC
HHS
February 1, 2022
Response to the Request for Information (RFI) on Strengthening Community Health Through Technology

Response to the Request for Information (RFI) on Strengthening Community Health Through Technology

HHS
ONC
Letter
September 1, 2021
Letter to ONC on CARIN IG for Blue Button® Data Class for USCDI 09302021

Letter to ONC on CARIN IG for Blue Button® Data Class for USCDI 09302021

HHS
OCR
Comment
May 1, 2021
Comments on HIPPA NPRM

Comments on HIPPA NPRM

HHS
CMS
Comment
January 1, 2021
Comments for CMS-9123-P Rule

Medicaid Program; Patient Protection and Affordable Care Act; Reducing Provider and Patient Burdenby Improving Prior Authorization Processes, and Promoting Patients’ Electronic Access to HealthInformation for Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIPManaged Care Entities, and Issuers of Qualified Health Plans on the Federally-facilitated Exchanges;Health Information Technology Standards and Implementation Specifications

FTC
Comment
August 1, 2020
Comments on FTC Health Breach Notification Rule

RE: Health Breach Notification Rule, 16 CFR part 318, Project No. P205405

HHS
ONC
Comment
June 1, 2019
"Proposed Trusted Exchange Framework "
HHS
CMS
Comment
June 1, 2019
Comments on 2019 proposed CMS Patient Access and Interoperability rule

RE: Medicare and Medicaid Programs: Patient Protection and Affordable Care Act; Interoperability andPatient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State MedicaidAgencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans in theFederally-facilitated Exchanges and Health Care Providers

HHS
Comment
June 1, 2019
Comments on 2019 proposed ONC Information Blocking rule
HHS
CMS
Comment
September 1, 2018
Comments on QPP Proposed Rule- 2019 proposed Physician Fee schedule and Quality Payment Program rule

RE: Medicare Program; Revisions to Payment Policies under the Physician Fee Scheduleand Other Revisions to Part B for CY 2019; Medicare Shared Savings ProgramRequirements; Quality Payment Program; and Medicaid Promoting InteroperabilityProgram

HHS
CMS
Comment
April 1, 2018
"Comments on 2019 proposed inpatient prospective payment system rule "

Re: Medicare Program; 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

HHS
ONC
Comment
February 1, 2018
Comments on the initial draft of the ONC’s 21st Century Cures Act Trusted Exchange Framework and Common Agreement
HHS
CMS
Comment
November 1, 2017
Comments on the CMMI New Direction RFI regarding “Consumer-Directed Care and Market Based Innovation Models”

RE: CMS: Innovation Center New Direction RFI

HHS
ONC
Comment
November 1, 2017
Comments on the 2018 ONC Interoperability Standards Advisory (ISA)

RE: 2018 Interoperability Standards Advisory (ISA)

HHS
Comment
October 1, 2017
"Comments on the HHS Draft Strategic Plan FY 2018-2022 "

RE: HHS DRAFT Strategic Plan FY 2018-2022

HHS
ONC
Comment
August 1, 2017
"Comments on the ONC’s 21st Century Cures Act Trusted Exchange Framework and Common Agreement (pre-release) "

RE: 21st Century Cures Act Trusted Exchange Framework and Common Agreement Public Comments

HHS
CMS
Comment
August 1, 2017
"Comments on the 2018 MACRA / Quality Payment Program proposed rule "

Re: Medicare Program; CY 2018 Updates to the Quality Payment ProgramDocket No. CMS-2017-0082

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