Editor’s Note: In the article below, Manatt Health provides an update on the latest policy developments around the No Surprises Act (NSA) and the vaccination mandate for health care workers. More information on the latest legal, policy and market developments is available on Manatt on Health, Manatt’s premium information service that keeps you ahead of the trends shaping our evolving health ecosystem. 

HHS Releases Several Guidance Documents Ahead of January 1 Implementation of No Surprises Act

As of January 1, 2022, the major provisions of the federal No Surprises Act (NSA) have gone into effect. The NSA, enacted in December 2020 as part of the Consolidated Appropriations Act, 2021, prohibits out-of-network health care providers from billing patients for amounts above their in-network cost-sharing for any emergency services at a hospital or freestanding independent emergency department or by air ambulance or for certain nonemergency services at an in-network hospital or ambulatory surgery center. The NSA defers to certain state laws in setting out-of-network provider reimbursement in those cases. Where state law does not determine the amount of reimbursement, the NSA establishes a federal independent dispute resolution (IDR) process to set provider reimbursement. However, several hospital and provider groups have challenged the federal regulations that set standards for how IDR entities will determine reimbursement amounts, throwing into question what standards will apply when the first IDR arbitrations occur later this year.

In the final weeks of 2021, the federal Department of Health and Human Services (HHS) released several guidance documents for patients, providers and health plans on the NSA, much of which restate rules that were published during 2021. The guidance documents focus on the good faith estimates that providers must give to uninsured or self-pay patients and the dispute resolution process that will apply to bills that exceed those estimates, as well as details of the federal IDR process for out-of-network provider reimbursement and the patient-provider dispute resolution process (PPDR). These guidance documents include the following:

• Federal Independent Dispute Resolution (IDR) Process Guidance for Certified IDR Entities. This document summarizes earlier rules on how parties may initiate the federal IDR process and how determinations are made, as well as guidance to IDR entities on confidentiality, recordkeeping and revocation of IDR entity certification. In addition, the guidance provides details regarding when and in what manner IDR entities should consider evidence other than the qualifying payment amount (QPA) in choosing the out-of-network reimbursement amount.
• Guidance on Good Faith Estimates and the Patient-Provider Dispute Resolution (PPDR) Process (for patients). This document is patient-facing guidance on how to request and interpret a good faith estimate and the process for initiating the PPDR process when the actual charges exceed the estimate by more than $400 for an uninsured or self-pay patient.
• Guidance on Good Faith Estimates and the Patient-Provider Dispute Resolution (PPDR) Process (for providers and facilities). This document provides detailed guidance to health care providers and facilities on notice requirements regarding the good faith estimate for uninsured or self-pay patients, how to prepare a good faith estimate, how to update a good faith estimate and the PPDR process.
• Guidance for Selected Dispute Resolution (SDR) Entities: Required Steps to Making a Payment Determination under the PPDR Process. This document provides guidance to dispute resolution entities on conducting the PPDR process for bills that exceed the good faith estimate by more than $400 for uninsured or self-pay patients.
• Good Faith Estimates for Uninsured (or Self-Pay) Individuals. These FAQs provide general information about the good faith estimate requirement.
• Patient-Provider Dispute Resolution (PPDR) Administrative Fee as Established in Surprise Billing, Part II; Interim Final Rule with Comment Period (CMS 9908-IFC). This document sets at $25 the administrative fee that uninsured or self-pay patients must pay to initiate the PPDR process for bills that are at least $400 more than the good faith estimate. The fee is applied to the provider’s charges if the patient prevails in the dispute resolution process.
• Consolidated Appropriations Act, 2021 Enforcement Letters. These letters from CMS to state governors describe CMS’ understanding of the manner in which the NSA will be enforced in each state: whether directly by the state, by the state in collaboration with the federal government or by the federal government alone. In addition, the letters state CMS’ determination regarding whether the out-of-network rate will be calculated based upon an All-Payer Model Agreement, a specified state law that determines the out-of-network rate, or the federal IDR process or a combination of state law and the federal IDR process. Finally, the letters contain information regarding whether patient-provider disputes regarding the cost of items and services that are substantially in excess of a good faith estimate will be decided under state or federal processes.  

For additional information, please see the HHS press release announcing the implementation of the NSA.

CMS Releases Updated Guidance on Vaccination Mandate for Health Care Staff in Half the U.S.

On December 28, 2021, the Centers for Medicare & Medicaid Services (CMS) released guidance and an updated set of FAQs on the implementation of the COVID-19 Health Care Staff Vaccination Interim Final Rule. The Interim Final Rule (IFR), released on November 5, 2021, requires vaccination of staff of health care providers and suppliers that are subject to CMS health and safety standards known as Conditions of Participation. As a result of ongoing legal challenges to the IFR, CMS’ implementation and enforcement of the rule is currently enjoined in 25 states (Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Utah, West Virginia and Wyoming).

The updated guidance released last week applies to Medicare- and Medicaid-certified providers and suppliers in the remaining 25 states, the District of Columbia and the territories. The guidance requires that such providers and suppliers establish policies and procedures that ensure as follows:

• By January 27, 2022 (30 days after the guidance was published): All eligible staff who do not have a pending or granted request for a qualifying exemption must receive either the single-dose Johnson & Johnson vaccine or at least the first dose of either the Pfizer or Moderna COVID-19 vaccines prior to providing any care, treatment or services for the provider/supplier or its patients.
• By February 28, 2022 (60 days after the guidance was published): All eligible staff who have not been granted a qualifying exemption must be fully vaccinated (either the single Johnson & Johnson dose or both doses of either the Pfizer or Moderna COVID-19 vaccines, as applicable) before providing care, treatment or other services for the provider/supplier or its patients.

CMS’ publication also included information and infographics on enforcement actions, deadlines and provider types for providers and suppliers in the states where this guidance is effective. The Supreme Court is set to hear arguments later this week regarding the validity of CMS’ vaccine requirement for health care workers as well as of the Occupational Safety and Health Administration emergency temporary standard for large employers to require employee vaccination later this week.