CHA Regulatory Tracker

Due May 6, 2021

• Changes to HIPAA Privacy Rule Proposed Rule
  • Extension of comment period
  • Summary

• CY 2021 DMEPOS Final Rule and Competitive Bidding Program Information​
  • Proposed Rule Summary
  • Proposed Rule

• Comprehensive Care for Joint Replacement (CJR) Model 3 Year Extension and Changes to Episode Definition and Pricing Final Rule Extension of Performance Year 5 to Sept. 30, 2021
  • CHA Proposed Rule Comment Letter
  • Extension of Comment Period 
  • Proposed Rule Summary 
  • Proposed Rule

• HHS OIG Information Blocking Civil Monetary Policies Final Rule
  • ​Proposed Rule

• Methods for Assuring Access to Covered Medicaid Services – Rescission Final Rule
  • 2019 Proposed Rule Comment Letter
  • Proposed Rule
  • ​2018 Proposed RuleComment Letter
  • ​2018 Proposed Rule
  • 2015 Final Rule with Comment Period Comment Letter
  • 2011 Proposed Rule Comment Letter

• Long-Term Care Facilities Conditions of Participation Final Rule
  • Comment Letter 
  • Proposed Rule Summary
  • Proposed Rule

• Accrediting Organization Ownership Changes Final Rule
  • ​CHA Comment Letter
  • Proposed Rule

• CLIA Proficiency Testing Regulations Related to Analytes and Acceptable Performance Final Rule 
  • Comment Letter
  • Proposed Rule

Effective January 1, 2021

• Hospital Price Transparency Final Rule​
  • Final Rule Summary

• CY 2021 Outpatient Prospective Payment System Final Rule
  • Final Rule Summary
  • CHA Proposed Rule Comment Letter
  • CHA Proposed Rule On-Demand Webinar
  • ​Proposed Rule Summary
  • Proposed Rule

• CY 2021 Physician Fee Schedule Final Rule 
  • Final Rule Summary
  • CHA Proposed Rule Comment Letter
  • CHA Proposed Rule On-Demand Webinar
  • ​Proposed Rule Summary
  • HPA PFS Rate Comparison
  • Proposed Rule

• CY 2021 Home Health Prospective Payment System Final Rule
  • Final Rule Summary 
  • CHA Comment Letter
  • ​Proposed Rule Summary
  • Proposed Rule

• CY 2021 End-stage Renal Disease Prospective Payment System Final Rule
  • Final Rule Summary
  • ​Proposed Rule Summary 
  • Proposed Rule

• Contract Year 2021 and 2022 Medicare Advantage and Part D Final Rule
  • Proposed Rule Summary
  • Proposed Rule

• CY 2021 Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies

Effective January 11, 2021

• Transparency in Coverage Final Rule
  • Final Rule Summary
  • Comment Letter
  • ​Proposed Rule Summary
  • Proposed Rule

Effective January 13, 2021

• 340B Drug Pricing Program Administrative Dispute Resolution Final Rule
  • Comment Letter

• Confidentiality of Substance Use Disorder Patient Records – Investigation or Prosecution of Extremely Serious Crime – Final Rule​
  • Proposed Rule Summary
  • Proposed Rule

Effective January 19, 2021

• Modernizing and Clarifying the Physician Self-Referral Regulations Final Rule
  • Final Rule Summary
  • Comment Letter
  • ​Proposed Rule Summary
  • Proposed Rule

• Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements Final Rule
  • Final Rule Summary
  • Comment Letter
  • ​Proposed Rule Summary
  • Proposed Rule

Effective March 15, 2021

• Final Notice of Benefit and Payment Parameters for 2022​
  • Proposed Rule Summary
  • Proposed Rule

Effective April 5, 2021

• 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (information blocking requirements)
  • Delay of Information Blocking Compliance 
  • Interim Final Rule Summary 
  • Final Rule Summary
  • Comment Letter
  • CHA Member Forum Slide Deck & Recording (April 19, 2019)
  • Extension of Comment Period to June 3
  • CHA Request for Extension of Comment Period 
  • ​Proposed Rule Summary
  • Proposed Rule

​Effective July 2021

• Specialty Care Models Final Rule (RO and ETC Models)
  • Delay of Implementation
  • CHA Executive Summary of RO Model
  • Final Rule Summary
  • Comment Letter
  • Member Forum Slide Deck & Recording (September 5)
  • ​Proposed Rule Summary
  • Proposed Rule

Effective January 1, 2022

• CY 2022 Final Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies

Effective January 1, 2023

• Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals (changes to existing discounts safe harbor)
  • Final Rule Summary
  • Delay of effective date

​Effective Date TBD due to Regulatory Freeze

• Reducing Provider and Patient Burden by Improving Prior Authorization Processes Final Rule
  • Comment Letter
  • ​Proposed Rule Summary
  • Proposed Rule

• Executive Order: Lowering Drug Prices by Putting America First (Part B Drugs, September 13, 2020)
• Executive Order: Lowering Drug Prices by Putting America First (Part D Drugs, September 13, 2020)
• Executive Order: Promoting the Rule of Law Through Improved Agency Guidance Documents (October 9, 2019)
• Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors (October 3, 2019)
• Executive Order on Price Transparency (June 24, 2019)
• Executive Order: Promoting Healthcare Choice and Competition Across the United States (October 12, 2017)
• Executive Order on Reducing Regulatory Burden (Jan. 30, 2017)​
  • Interim Guidance on Implementation of Section 2 of EO (Feb. 2, 2017)
• Presidential Memorandum – Regulatory Freeze (Jan. 20, 2017)​
  • OMB Memorandum – Implementation of Regulatory Freeze (Jan. 24, 2017)
• Executive Order on Reducing ACA Burden (Jan. 20, 2017)​
  • OMB Budgetary Statement (Jan. 26, 2017)

• Hospital Price Transparency 
• AWI Litigation
• Alternative Payment Model Resources
• IMPACT Act Resources
• MACRA Resources
• Worksheet S-10 Resources