On the evening of October 28, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a press release, fact sheet, and an unpublished interim final rule with comment period (IFC) on its website related to the COVID-19 public health emergency (PHE). The IFC interprets and implements CARES Act requirements regarding COVID-19 immunizations and treatments, as well as other specified policies:

• Discusses the CMS implementation of Section 3713 of the CARES Act (Pub. L. 116-136),[1] which established Part B coverage and payment for COVID-19 vaccines and their administration;
• Implements CARES Act requirements that providers of COVID-19 diagnostic tests provide public information on the cash prices for the tests;
• Establishes enforcement mechanisms for providers that fail to publish or charge published prices;
• Includes IPPS add-on payment for cases using new COVID-19 treatments;
• Provides separate OPPS payment for new COVID-19 treatments for the remainder of the PHE when provided at the same time as a comprehensive ambulatory classification (C-APC) service;
• Implements requirement in the FFCRA (Pub. L. 116-127)[2] that states maintain Medicaid enrollment in order to receive temporary increase in the Federal Medical Assistance Percentage (FMAP);
• Makes changes to the Comprehensive Care for Joint Replacement (CJR) model;[3]
• Amends regulations to implement CARES Act requirements that shorten the timeframe with which certain insurers must cover coronavirus preventive services, including COVID-19 immunizations; and
• Revises regulations to allow flexibilities in public notice requirements and post-award public participation requirements for State Innovation Waivers, also known as Section 1332 waivers.[4]

CMS believes that the urgency of the COVID-19 PHE constitutes good cause to waive the normal notice-and-comment process and the normal 30-day delay in effective date. Thus, unless otherwise noted, these changes are immediate upon display in the Federal Register and are applicable for the duration of the COVID-19 PHE. Comments are due within 60 days after the date of display in the Federal Register.

Part B Coverage and payment for COVID-19 vaccination

The rule implements numerous measures to help ensure the American population has timely access and minimal out-of-pocket costs for a COVID-19 vaccine, regardless of their health insurance coverage. The IFC interprets and implements Section 3713 of the CARES Act, which added COVID-19 vaccination (vaccine and administration) to the Social Security Act as a covered service.[5] Section 3713 also specified that under Medicare Part B, beneficiaries who receive the vaccination have no cost-sharing.

As directed by Section 3202 of the CARES Act, the Departments of HHS, Labor, and Treasury (“the Departments”) jointly address vaccination coverage and cost-sharing in the IFC as it applies to the Employee Retirement Income Security Act (ERISA) and the Internal Revenue Code (the Code). The Departments change the relevant regulations to implement the requirements for rapid coverage of qualifying coronavirus preventive services:

• Defines qualified coronavirus preventive services consistent with Section 3202 of CARES Act;
• Clarifies that plans and issuers must cover recommended immunizations even if not listed on immunization schedules produced by the Centers for Disease Control and Prevention (CDC);
• Provides that during the COVID-19 PHE, that plans and issuers must cover, without cost-sharing, qualifying coronavirus preventive services, regardless of provider network status; and
• Coverage is REQUIRED within 15 business days after the date the USPTF[6] or the ACIP[7] makes a recommendation regarding a qualifying coronavirus preventive service.

Cost transparency requirements and enforcement

The CARES Act (Section 3002) also requires that providers and suppliers publish a cash price for COVID-19 diagnostic testing during the PHE. The IFC codifies this requirement at 45 CFR part 182 by defining “provider,” “cash price,” and “COVID-19 diagnostic test.” It also includes the posting requirements to include websites or upon request and through signage (if provider does not have its own website). CMS has discretion under the IFC to escalate enforcement actions, up to a civil monetary penalty (CMP).

New IPPS Add-on payment for cases including drug or biological products authorized or approved for COVID-19

Until the end of the COVID-19 PHE, the IFC establishes a New COVID-19 Treatments Add-on Payment (NCTAP) for certain cases that include the use of a drug or biological product currently authorized or approved for treating COVID-19. The NCTAP will pay hospitals the lesser of:

• 65 percent of the operating outlier threshold for the claim or
• 65 percent of the amount by which the costs of the case exceed the standard DRG payment.[8]

Separate OPPS payment for new COVID-19 treatments when provided as part of C-APC service

Until the end of the COVID-19 PHE, the IFC provides for a separate payment for New COVID-19 Treatments similar to the inpatient setting but only when those treatments are provided at the same time as a comprehensive ambulatory payment classification (C-APC) service.

Temporary increase in medicaid FMAP requirements

The IFC implements a section of the FFCRA (Pub. L. 116-127), which requires states to maintain their beneficiary enrollment with specified protections as a condition of their receiving an enhanced Federal Medical Assistance Percentage (FMAP). The rule codifies the expectation effective immediately upon display and replaces CMS’ previous interpretation.

CMS modifies the CJR MODEL to account for COVID-19

The IFC modifies the Comprehensive Care for Joint Replacement (CJR) model and makes various technical changes to help address COVID-19. Specifically, the IFC:

• Extends Performance Year (PY) 5 an additional 6 months;
• Creates an episode-based extreme and uncontrollable circumstances (ECE) COVID-19 policy;
• Provides two reconciliation periods for PY 5; and
• Adds DRGs 521 and 522 for hip and knee procedures.

CMS adds flexibilities for section 1332 waivers

The IFC provides flexibilities for Section 1332 Waivers (also known as State Innovation Waivers) from states that apply during the COVID-19 PHE. The IFC gives the Secretaries of HHS and Treasury the authority to modify public notice procedures to expedite a decision on a proposed waiver request during the COVID-19 PHE. The IFC also gives these Secretaries the authority to modify the post-award public notice requirements for an approved waiver request during the COVID-19 PHE.

[1] https://www.congress.gov/116/plaws/publ123/PLAW-116publ123.pdf

[2] https://www.congress.gov/116/plaws/publ127/PLAW-116publ127.pdf

[3] https://innovation.cms.gov/innovation-models/cjr

[4] https://www.cms.gov/CCIIO/Programs-and-Initiatives/State-Innovation-Waivers/Section_1332_State_Innovation_Waivers-

[5] Sec. 1861(s)(10)(A). [42 U.S.C. 1395x]

[6] United States Preventive Services Task Force: https://uspreventiveservicestaskforce.org/uspstf/home

[7] Advisory Committee on Immunization Practices: https://www.cdc.gov/vaccines/acip/index.html

[8] The NCTAP will not be included as part of the calculation of the operating outlier payments.