Advocacy & Public Affairs

Since many of our Registry policies and procedures closely follow Centers for Medicare & Medicaid (CMS) and government regulations, we have an advocacy and public affairs program that monitors issues and viewpoints of the orthopaedic community before Federal and State legislative, regulatory, and executive agencies. Based in Washington, D.C., but also including staff from our Rosemont, Ill. office, our program identifies, analyzes, and directs all health policy activities and initiatives of the AJRR.

The Common Rule

We get a lot of questions pertaining to the “The Common Rule” that we’d like to address:

The Common Rule does not apply to AJRR activities as that rule relates to research that is “conducted, supported, or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research.” The Common Rule defines “research subject to regulation” as:

Research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration).  It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department’s or agency’s broader responsibility to regulate certain types of activities whether research or non-research in nature.

Where the Common Rule applies, it covers research involving human subjects, which includes the collection of identifiable patient information. The Common Rule does not apply to privately-funded research activities such as the AJRR that are not otherwise subject to federal regulation.

The Common Rule also does not apply to participants that submit data to the AJRR. The HHS Office for Human Research Protections has clearly stated that data collected in the course of clinical care that is submitted to external researchers is not human subjects research and therefore is not subject to the Common Rule. Specifically, “Institutions whose employees or agents release to investigators at another institution identifiable private information or identifiable biological specimens pertaining to the subjects of the research” are not engaged in human subjects research. Thus, hospitals that submit PHI collected in the course of clinical care to national registries for research purposes are not engaged in human subjects research.

Nonetheless, AJRR has obtained a waiver of the Common Rule informed consent requirement from WIRB to cover the collection of patient information for research purposes. The Office for Human Rights Protections, like OCR, strongly supports the use of central IRB review for multicenter clinical research, including research conduct or facilitated by clinical data registries.

Access the AJRR HIPAA/Common Rule Compliance Strategy here.

Protected Health Information (PHI)

Our Registry collects and utilizes data derived from information submitted by physicians, hospitals, and manufacturers related to joint replacements. Some of this data will qualify as protected health information (PHI) under the Health Information Portability and Accountability Act of 1996 (HIPAA) Privacy and Security rules. Since many of our participants ask for clarification as it pertains to this, we’ve included our HIPAA compliance strategy. It also addresses the applicability of the Common Rule.

Access the AJRR HIPAA/Common Rule Compliance Strategy here.

Access the HIPAA Final Omnibus Rule here

Comment Letters

Physician Clinical Registry Coalition's Joint Letter to CMS on QCDR Quality Measures - October 2016
AJRR Comment to the House Ways and Means Health Subcommittee for holding the hearing on Incentivizing Quality Outcomes in Medicare Part A - September 2016
AJRR Comment Letter to CMS on MIPS and APM Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models - June 2016
Physican Clinical Registry Coalition's Joint Letter to CMS on MIPS and APM Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models - June 2016
Physican Clinical Registry Coalition's Joint Letter to CMS on Medicare Program: Expanding Uses of Medicare Data by Qualified Entities - March 2016
AJRR Comment Letter to CMS on Medicare Program: Expanding Uses of Medicare Data by Qualified Entities - March 2016
AJRR Comment Letter to Senate Health, Education, Labor and Pensions Committee to Improved Health Information Technology - January 2016
Physican Clinical Registry Coalition's Joint Letter to Senate Health, Education, Labor and Pensions Committee - January 2016
Physician Clinical Registry Coalition's Joint Letter to CMS on Proposed Making on the Common Rule - January 2016
AJRR OHRP Comment Letter on Proposed Rule Making on the Common Rule - January 2016
AJRR CMS Comment Letter on Meaningful Use Stage 3 - December 2015
AJRR CMS Comment Letter on EHR Incentive Program - December 2015
AJRR CMS Comment Letter on MACRA - November 2015
AJRR FDA Comment Letter on MDEpiNet - October 2015
AJRR CMS Comment Letter on Physician Fee Schedule for CY 2016 - September 2015
AJRR CMS Comment Letter on CJR - September 2015
AJRR and PCRC Comment Letter to SACHRP on Common Rule - July 2015

The Medicare Access and CHIP Reauthorization Act (MACRA) and Delivery Reform

On April 27, 2016, the Department of Health and Human Services issued a Notice of Proposed Rulemaking to implement key provisions of the Medicare Access and CHIP Reauthorization Act (MACRA), bipartisan legislation that replaced the flawed SGR formula with a new approach to paying clinicians for the value and quality of care they provide. The proposed rule implements these changes through the unified framework called the “Quality Payment Program,” which includes two paths: the Merit-Based Incentive Payment System (MIPS) or the Advanced Alternative Payment Models (APMs).

The registry community also recently received clarification from the HHS Office for Human Research Protections regarding applicability of the Common Rule to various registry activities.

The Merit-based Incentive Payment System (MIPS)

Currently, Medicare measures the value and quality of care provided by doctors and other clinicians through a patchwork of programs, including PQRS, the VBM, and the Medicare Electronic Health Record (EHR) Incentive Program. Through the law, Congress streamlined and improved these programs into one new system called MIPS. Most Medicare clinicians will initially participate in the Quality Payment Program through MIPS.

Consistent with the goals of the law, the proposed rule would improve the relevance and depth of Medicare’s value and quality-based payments and increase clinician flexibility by allowing clinicians to choose measures and activities appropriate to the type of care they provide. MIPS allows Medicare clinicians to be paid for providing high quality, efficient care through success in four performance categories: Cost (10%), Quality (50%), Clinical Practice Improvement Activities (CPIAs) (15%) and Advancing Care Information (25%). Clinicians’ MIPS scores would be used to compute a positive, negative, or neutral adjustment to their Medicare payments. In the first year, depending on the variation of MIPS scores, adjustments are calculated so that negative adjustments can be no more than 4 percent, and positive adjustments are generally up to 4 percent, with additional bonuses for the highest performers. The maximum negative adjustment in 2020 is 5 percent, 7 percent in 2021, and 9 percent in 2022 and thereafter.

Advanced Alternative Payment Models (APMs)

APMs are the CMS Innovation Center models, Shared Savings Program tracks, or statutorily-required demonstrations where clinicians accept both risk and reward for providing coordinated, high-quality, and efficient care. These models must also meet criteria for payment based on quality measurement and for the use of EHRs. From 2019 through 2024, Qualifying APM Professionals (QPs) would receive a lump sum payment equal to 5 percent of the estimated aggregate payment amounts for Part B services. Clinicians participating in APMs are excluded from MIPS.

Acronyms

AAHKS: American Association of Hip and Knee Surgeons
AAOS: American Association of Orthopaedic Surgeons
ABMS: American Board of Medical Specialties
ABOS: American Board of Orthopaedic Surgery
ACA: Affordable Care Act
ACO: Accountable Care Organizations
AHA: American Hospital Association
AJRR: American Joint Replacement Registry
AMA: American Medical Association
APM: Alternative Payment Model
CAHPS: Consumer Assessment of Healthcare Providers and Systems Survey
CDC: Centers for Disease Control and Prevention
CJR: Comprehensive Care for Joint Replacement model         
CJRR: California Joint Replacement Registry
CMS: Center for Medicare & Medicaid Services

DHHS:  Department of Health and Human Services

eCQM: Electronic Clinical Quality Measures
EHR: Electronic Health Record
EMR: Electronic Medical Record
EP: Eligible Professional as in a medical professional, doctor, surgeon
FDA: U.S. Food and Drug Administration
GPRO: Group Practice Reporting Option
HIPAA: Health Insurance Portability and Accountability Act
ICOR: International Consortium of Orthopaedic Registries
IRB: Institutional Review Board
ISAR: International Society of Arthroplasty Registers
JBJS: Journal of Bone and Joint Surgery
MACRA: Medicare Access and CHIP Reauthorization Act
MDEpiNet: Medical Device Epidemiology Network Initiative
MIPS: Merit-Based Incentive Payment System
MOC: Maintenance of Certification (from the ABOS)
MU: Meaningful Use of Electronic Medical Records CMS
NCQA: National Committee on Quality Assurance
NQF: National Quality Forum
NQRN: National Quality Registry Network
NQS: National Quality Strategy
NsQIP: National Surgical Quality Improvement Program
OCSQ: Office of Clinical Standards and Quality
OHRP: Office for Human Research Protections (HHS)
ONC: Office of the National Coordinator for Health Information Technology
PCPI: Physician Consortium for Performance Improvement
PFS: Medicare Physician Fee Schedule
PHI: Protected Health Information
PQRS: Physician Quality Reporting System – CMS Program
PROMs: Patient Reported Outcome Measures
PSQIA: Patient Safety and Quality Improvement Act
QCDR: Qualified Clinical Data Registry
SGR: Sustainable Growth Rate: control spending by Medicare on physician services
THA: Total Hip Arthroplasty
THR: Total Hip Replacement
TJC: The Joint Commission
TJR: Total Joint Replacement
TKA: Total Knee Arthroplasty
TKR: Total Knee Replacement
UDI: Unique Device Identifier
VM: Value Based Modifier – CMS Program
WIRB: Western Institutional Review Board
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