On October 28, the U.S. Department of Health and Human Services (HHS), the U.S. Department of Labor, and the U.S. Department of the Treasury released the coverage transparency final rule. Building on earlier administration actions requiring hospitals to disclose standard charges and negotiated rates with third-party payers, this new rule includes two requirements aimed at increasing healthcare price transparency in the commercial market.

First, health plans and payers will be required to provide participants, beneficiaries, and enrollees with personalized out-of-pocket cost information, and the underlying negotiated rates, for all covered health care items, services, and prescription drugs. Plans and payers must provide cost-sharing information through an internet-based self-service tool or in paper form upon request. An initial list of 500 services as determined by the departments must also be available for plans on January 1, 2023. The remainder are required to be available for plans on January 1, 2024.

Second, the rule requires payers and plans to post three data files for public use: 1) negotiated rates for all covered items and services between the plan or payer and in-network providers; 2) historical payments to, and billed charges from, out-of-network providers; and 3) in-network negotiated rates and historical net prices for all covered prescription drugs by plan or issuer at the pharmacy location level. These files are required to be made public for plan years that begin on or after January 1, 2022.

Learn more about the coverage transparency rule.

The Centers for Medicare & Medicaid Services (CMS) released its fourth COVID-19 interim final rule with comment period. This rule requires U.S. Food and Drug Administration-approved COVID-19 vaccines to be provided at no-cost to beneficiaries enrolled in Medicare and Medicare Advantage. Medicaid beneficiaries can receive the vaccine at no cost only during the public health emergency (PHE), and most private payors will also be required to provide the vaccine at no cost. While codes to bill vaccines will not be available until the vaccines have been approved, CMS has set reimbursement rates for single and multiple vaccine doses. Additionally, CMS is continuing efforts around transparency by requiring any provider who performs a COVID-19 diagnostic test to post their prices online.

Learn more about the fourth COVID-19 interim final rule.

Additionally, the Office of the National Coordinator for Health Information Technology (ONC), released an interim final rule with comment period that, due to the COVID-19 PHE, provides flexibilities for health IT developers and health care providers in the Health IT Certification Program. Specifically, the rule:

• Delays the information blocking provisions, which were set to go into effect Monday, November 2nd, are now delayed until April 5, 2021
• Availability of standardized application programming interfaces are delayed until December 31, 2022
• Extends the compliance dates in the ONC Health IT Certification Program, including certain 2015 edition health IT certification criteria and conditions and Maintenance of Certification requirements
• Makes changes to the program by updating standards and clarifying regulatory text for specific certification criteria

ASCO is reviewing these three rules and will provide more in-depth analysis. Stay tuned to ASCO in Action for additional details.