Background
On October 7, 2021, the Department of Health and Human Services (HHS), in conjunction with the Office of Personnel Management (OPM), Department of the Treasury (DOT), and Department of Labor, including the Internal Revenue Service (IRS) and Employee Benefits Security Administration (EBSA) (collectively “the Departments”), published the second iteration of the interim final rules implementing certain provisions of the No Surprises Act (NSA), which was enacted as part of the Consolidated Appropriations Act, 2021.
These interim final rules (IFRs) implement provisions of the NSA that provide for a Federal Independent Dispute Resolution (Federal IDR) process to permit group health plans, and health insurance issuers offering group or individual health insurance coverage, and nonparticipating providers, facilities, and providers of air ambulance services to determine the out-of-network rate for items and services that are emergency services, nonemergency services furnished by nonparticipating providers at participating facilities, and air ambulance services furnished by nonparticipating providers of air ambulance services. In addition to the IFRs issued jointly by the Departments, this document includes IFRs issued by HHS that address good faith estimates of health care items and services for uninsured or self-pay individuals and the associated patient-provider dispute resolution process. The HHS-only interim final rules apply to selected dispute resolution (SDR) entities, providers, facilities, and providers of air ambulance services.
The Departments are seeking comment on these interim final rules until December 5, 2021. Utilize this template to submit your comments. Comments can be submitted online here.
Four Proposed Requirements You Need to Know
1) The Federal Independent Dispute Resolution Process
2) External Review
3) Good Faith Estimates to Uninsured and Self-Pay Individuals
4) Patient-Provider Dispute Resolution Process
A detailed explanation of the four key items is below. Click here for a comprehensive comparison of NSA requirements previously and the new proposed requirements in this IFR.
Federal Independent Dispute Resolution Process
Applies to Insured Patients and Out-of-Network Items and Services
Notice of Open Negotiation PeriodThe notice of intent to negotiate must include information sufficient to identify the items and/or services to be subject to the negotiation, including:
The notice must be delivered in writing to the other party within 30 business days of the initial payment or denial. Notice can be satisfied electronically by email if:
For electronic notices, the date the notice is sent will also be considered the date it is received, but parties should make efforts to confirm contact information receipt. If the notice is not properly provided to the other party, and no reasonable effort has been made to ensure receipt, then the Departments may determine that the 30-business-day open negotiation period has not begun, potentially rendering any subsequent payment determination from an IDR entity unenforceable. The Departments have issued a standard notice form which can be found at: https://www.dol.gov/sites/dolgov/files/ebsa/laws-and-regulations/laws/no-surprises-act/surprise-billing-part-ii-information-collection-documents-attachment-2.pdf |
Duration of Open Negotiation PeriodThe 30-business-day open negotiation begins on the day the open negotiation notice is sent by the party. The parties may discontinue the negotiation if they agree on an out-of-network rate before the last day of the thirty-business-day period. |
Initiation of the Federal Independent Dispute Resolution (IDR) ProcessA federal independent dispute resolution portal is being established and will be available at https://www.nsa-idr.cms.gov. The initiation period for the IDR process is four (4) business days, starting the day after the open negotiation ends. The initiation of the IDR process starts on the date of submission, or a date specified by the Departments. The entity initiating IDR must submit notice to the other party and the Departments. The notice may be electronically submitted and mustcontain the below:
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Agreement on a Certified Dispute Resolution Entity
Notice of Certified Dispute Resolution EntityBy the conclusion of the four (4) day IDR initiation period, the initiating party must notify the Departments electronically of the IDR entity selection or the failure to select one. . Content of Notice If both parties agree on a certified IDR entity, the notice of the selection must include the following:
If the parties cannot agree on an IDR entity, or if there is a conflict of interest, the Departments will randomly select an IDR entity within six (6) business days of the initiation period. A conflict of interest, under this IFR, would be a material relationship, status, or condition of the party, or certified IDR entity that impacts its ability to make an unbiased and impartial payment determination.[1] Authority to Continue NegotiationIf parties agree on a rate after IDR initiation but before the IDR determination, then the initiating party must notify the Departments and the IDR entity as soon as possible but no later than within 3 business days. Submission of Offers to an IDR Entity: After an IDR entity is selected, the parties must submit:
Offer Submission Date Offers and additional information are due ten (10) business days after the date of the IDR entity selection. |
Certified Independent Dispute Resolution Entity DecisionThe IDR entity will issue a binding determination selecting one of the offers as the appropriate OON payment amount. Certified Independent Dispute Resolution Entity Criteria: The IDR entity should make its determination based on:
Decision Date: Determination of payment will be made within 30 business days after the IDR is selected. Payment submitted to applicable party: Payment is due within 30 calendar days of the IDR’s payment determination. Both parties must pay an administrative fee ($50 each for 2022) and an IDR entity fee (determined by the entity). Payment for these fees can be made in the federal IDR portal. Within 30 days of determination, the prevailing party will receive a refund of the IDR entity fee..
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Effect of IDR DeterminationItems that arise during this 90-calendar day suspension period will then be able to be batched together and submitted after the period ends. Normally, all batched items[2] submitted must have occurred within the same 30-day period. |
Good Faith Estimate – DefinedGood Faith Estimate means a notification of expected charges for a scheduled or requested item or service, including items or services that are reasonably expected to be provided in conjunction with such scheduled or requested item or service, provided by a convening provider, convening facility, co-provider, or co-facility. |
Good Faith Estimate – Expected ChargeExpected charge means, for an item or service, the cash pay rate or rate established by a provider or facility for an uninsured (or self-pay) individual, reflecting any discounts for such individuals. This means that the good faith estimate can be the gross charges or chargemaster rates if that is the amount the individual is expected to pay, but HHS wants this estimate to be accurate so it should reflect any discounts that would be extended to uninsured or self-pay individuals, including any applicable financial assistance policy. |
Good Faith Estimate – Items and ServicesGood faith estimate applies to the “primary item or services” — i.e., the initial reason for the visit. It also applies to items or services that are reasonably expected to be provided with care scheduled by all providers and facilities, like imaging and lab services. It does not apply to unanticipated or emergent care. |
Good Faith Estimate – Period of CareA good faith estimate must reflect the expected charges during a “period of care.” Period of care means the day or multiple days during which the good faith estimate for a scheduled or requested item or service (or set of scheduled or requested items or services) are furnished or are anticipated to be furnished, regardless of whether the convening provider, convening facility, co-providers, or co-facilities are furnishing such items or services, including the period of time during which any facility equipment and devices, telemedicine services, imaging services, laboratory services, and preoperative and postoperative services that would not be scheduled separately by the individual, are furnished. |
Convening Providers/Facilities Versus Co-Providers/FacilitiesThe “convening health care provider or health care facility” is the entity that receives the initial request for an estimate and is responsible for scheduling the primary item or service. The co-providers/facilities are those providers or facilities who are not the convening provider/facility but will furnish items or services that are customarily provided with the primary item or service. |
Good Faith Estimate – ExampleKnee Surgery Example: A good faith estimate could include an itemized list of items or services in conjunction with and including the actual knee surgery (such as physician professional fees, assistant surgeon professional fees, anesthesiologist professional fees, facility fees, prescription drugs, and durable medical equipment fees) that occur during the period of care. An individual would not typically schedule days in the hospital post-procedure separately from scheduling the primary service of a knee surgery. HHS would therefore expect that all the items or services that are reasonably expected to be provided from admission through discharge as part of that scheduled knee surgery, from all physicians, facilities, or providers be included in the good faith estimate. |
Notice of Availability of Good Faith Estimates – Uninsured (or self-pay)Convening providers/facilities must inform uninsured (or self-pay) individuals that good faith estimates of expected charges are available to individuals upon scheduling an item or service or upon request[4]. This information must be provided in writing and orally during scheduling an item or service or when the individual has questions about the cost. Notice regarding the availability of good faith estimates:
HHS anticipates providing a model notice for notifying individuals of the availability of good faith estimates, but it is not yet available, and HHS will not require its use. |
Gathering the Good Faith Estimates from Co-Providers and Co-FacilitiesThe convening provider/facility must contact all applicable co-providers and co-facilities to request their good faith estimates no later than 1 business day after the request for the good faith estimate is received or after the primary item or service is scheduled. This request must include a date that their good faith estimate is due back. |
New Good Faith Estimates – Uninsured (or self-pay)New (i.e., updated) good faith estimates are due to the individual when information used to create the original good faith estimate changes. The new estimate must be issued no later than one (1) business day before the item or service is scheduled. The same applies if there are any changes in the expected providers or facilities who will be providing the items or services. In situations where an individual only requests a good faith estimate but does not schedule the service until after receiving that estimate, then a new estimate must be provided to the individual upon scheduling the item or service. In these situations, HHS encourages reviewing any previously issued good faith estimates before issuing a new one, and then communicating to the individual any changes between the two. |
Good Faith Estimates for Recurring Items or Services – Uninsured (or self-pay)Good faith estimates may be issued for recurring primary items or services if the following are met:
Anything items or services beyond 12 months require a new good faith estimate with an explanation of any changes.. |
Content of a Good Faith Estimate for an Uninsured (or Self-Pay) IndividualA good faith estimate issued by the convening provider/facility to the uninsured (or self-pay) individual must include:
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Requirements for Co-Providers and Co-Facilities Submitting Good Faith Estimate Information – Uninsured (or self-pay)The good faith estimate information submitted by co-providers or co-facilities must include:
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Separately Scheduled Items and Services Impact to Good Faith Estimate – Uninsured (or self-pay)For situations where certain items or services will need to be separately scheduled, the good faith estimate must include a list of those items or services which will require separate scheduling. The good faith estimate must also include a disclaimer that notifies the uninsured (or self-pay) individual that:
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Required Methods for Providing Good Faith Estimates for Uninsured (or Self-Pay) IndividualsThe good faith estimate must be provided in written form either on paper or electronically, pursuant to the uninsured (or self-pay) individual’s requested method of delivery. For good faith estimates provided electronically, they must be provided in a manner that the individual can both save and print and must be use clear and understandable language in a manner calculated to be understood by the average individual. If an uninsured (or self-pay) individual requests a good faith estimate be provided orally, the convening provider/facility may discuss the information included in the good faith estimate but it will also issue the good faith estimate in written form. The good faith estimate may be issued to the authorized representative to the extent not prohibited under state law. There are additional requirements to use clear and understandable language recognizing communication, and literacy barriers, and providers and facilities should also take into account any vision, hearing, or language limitations; communication needs of underserved populations; individuals with limited English proficiency; and persons with health literacy needs. |
Good Faith Estimates Record KeepingA good faith estimate is considered part of the patient’s medical record and must be maintained in the same manner. Convening providers/facilities must provide a copy of any previously issued good faith estimate furnished within the last six (6) years to an uninsured (or self-pay) individual upon request. |
Errors or Omissions in Good Faith EstimateIn circumstances in which a provider or facility, acting in good faith, makes an error or omission in a good faith estimate, a provider or facility must still comply with this section despite acting in good faith and with reasonable due diligence. If the provider or facility makes an error or omission in a good faith estimate, they must correct it as soon as practicable. However, if the services are furnished before the error in the good faith estimate is addressed, the provider or facility may be subject to patient-provider dispute resolution if the billed charges are substantially in excess of the good faith estimate. The provider or facility will not be in violation if it relied in good faith on information from another entity, unless the provider or facility knows, or reasonably should have known, that the information is incomplete or inaccurate. |
Complaints Against Other ProvidersHHS notes that providers and facilities (including convening providers/facilities or co-providers/co-facilities) who experience other providers’ or facilities’ failures to comply with the requirements in these interim final rules may file a complaint for enforcement investigation. |
Enforcement Discretion in 2022HHS understands that it may take time for providers and facilities to develop systems and processes for receiving and providing the required information from co-providers and co-facilities. Therefore, for good faith estimates provided to uninsured (or self-pay) individuals from January 1, 2022 through December 31, 2022, HHS will exercise its enforcement discretion in situations where a good faith estimate provided to an uninsured (or self-pay) individual does not include expected charges from co-providers or co-facilities. |
Good Faith Estimate VariationsWhere good faith estimates are also required in other provisions of the NSA: HHS recognizes that providers and facilities have some discretion in the assumptions that they make regarding which items or services to include in a good faith estimate, and that some natural variation may occur across providers and facilities in terms of which items or services they would include in an estimate. However, HHS is of the view that it is critical for providers and facilities to apply the same process and considerations in developing the good faith estimate required under other sections of the NSA to avoid consumers receiving two different estimates describing care from the same provider or facility for the same care. |
[1] HHS notes that uninsured (or self-pay) individuals may use different terminology other than “good faith estimate” when requesting a good faith estimate. Convening providers and convening facilities shall therefore consider any discussion or inquiry regarding the potential cost of items or services under consideration as a request for a good faith estimate.
Protections for Uninsured or Self-Pay Individuals: Patient-Provider Dispute Resolution Process
Applies to Uninsured/Self-Pay Individuals
Eligibility for Patient-Provider Dispute Resolution ProcessA patient’s bill will be eligible for the patient-provider dispute resolution process if the following conditions are met:
Note that payment of all or part of the billed charges by the uninsured (or self-pay) individual (or by another party on their behalf) does not demonstrate agreement by the individual to settle at that amount or any other amount and the individual may still pursue the dispute resolution process. |
Initiation of Patient-Provider Dispute ResolutionThe Patient-Provider Dispute Resolution (PPDR) process can only be initiated by an uninsured (self-pay) individual by providing notice to HHS within 120 calendar days of receiving the bill containing charges for the items or services that is substantially in excess of the expected charges. HHS selects the dispute resolution entity if the eligibility factors are met. The selected dispute resolution entity will provide notice to all parties with information identifying the item or service under dispute and various other related information. No later than ten (10) business days after the receipt of notice from the selected dispute resolution entity a provider or facility must submit information, including:
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Provider Rules During the Patient-Provider ResolutionAll collection efforts must cease when a PPDR is pending, including the accrual of any late fees. Retributive action against an uninsured (self-pay) individual is prohibited. |
Dispute Resolution Entity DeterminationThe SDR entity should use the expected charges in the good faith estimate as the presumed appropriate amount and unless the provider or facility provides credible information justifying the difference between the total billed charges and the good faith estimate by demonstrating that the difference between the billed charges and the expected charges in the good faith estimate for the item or service reflects the costs of a medically necessary item or service and is based on unforeseen circumstances that could not have reasonably been anticipated by the provider or facility when the good faith estimate was provided. For this purpose, information is credible if critical analysis the information shows it is worthy of belief and consists of trustworthy information. SDR determinations are binding and not subject to judicial review. |
Administrative FeeThe IFR provides that the administrative fee may be no more than $25.00 assessed to the non-prevailing party. |
SettlementThe parties may agree to resolve the dispute by settling on a payment amount at any point after the PPDR has been initiated but before the date on which a determination is made by the dispute resolution entity. The parties can settle the payment amount through either an offer of financial assistance, an offer to accept a lower amount, or via an agreement by the individual to pay the billed charges in full. In the event that the parties agree to settle on a payment amount, the provider or facility should notify the dispute resolution entity through the Federal IDR Portal, electronically, or in paper form, as soon as possible, but no later than 3 business days after the date of the agreement. The settlement notification must contain at a minimum, the settlement amount, the date upon which settlement was reached, and documentation demonstrating that the provider or facility and uninsured (or self-pay) individual have agreed to the settlement. The settlement notice must also document that the provider or facility has applied a reduction to the uninsured (or self-pay) individual’s settlement amount that is equal to at least half the amount of the administrative fee paid. |
How to Take Action
CMS is accepting comments to the proposed IFRs until December 5, 2021. Utilize this template to submit your comments. Comments can be submitted online here.
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Additional Resources:
Federal Register: https://www.govinfo.gov/content/pkg/FR-2021-10-07/pdf/2021-21441.pdf Regulations.gov: https://www.regulations.gov/document/CMS-2021-0156-0001
[1] Additionally, a conflict is when:
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An IDR entity is, or is an affiliate or subsidiary of, a group health plan, a health insurance issuer offering group health insurance coverage, individual health insurance coverage or short-term, limited-duration insurance, an FEHB carrier, or a provider, a facility, or a provider of air ambulance services. (While the NSA does not specify that the independent dispute resolution entity must not be a health insurance issuer offering short-term, limited-duration insurance, the Departments have determined that would also be prohibited);
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An IDR entity is an affiliate or subsidiary of a professional or trade association representing group health plans, health insurance issuers offering group health insurance coverage, individual health insurance coverage or short-term, limited-duration insurance, FEHB carriers, or providers, facilities, or providers of air ambulance services;
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An IDR entity has, or any personnel assigned to a determination have, a material familial, financial, or professional relationship with a party to the payment determination being disputed, or with any officer, director, or management employee of the plan, issuer or carrier offering a health benefits plan, the plan administrator, plan fiduciaries, or plan, issuer, or carrier’s employees, the health care provider, the health care provider’s group or practice association, the provider of air ambulance services, the provider of air ambulance services’ group or practice association, or the facility that is a party to the dispute.
[2] Batched items and services are qualified IDR items or services that are considered jointly as part of a single payment determination.
[3] Uninsured (or self-pay) individual means: (A) An individual who does not have benefits for an item or service under a group health plan, group or individual health insurance coverage offered by a health insurance issuer, Federal health care program (as defined in section 1128B(f) of the Social Security Act), or a health benefits plan under chapter 89 of title 5, United States Code; or (B) An individual who has benefits for such item or service under a group health plan, or individual or group health insurance coverage offered by a health insurance issuer, or a health benefits plan under chapter 89 of title 5, United States Code but who does not seek to have a claim for such item or service submitted to such plan or coverage.
Note here that persons enrolled only in a short-term limited duration insurance policy would be considered uninsured for purposes of the good faith estimate.
[4] HHS notes that uninsured (or self-pay) individuals may use different terminology other than “good faith estimate” when requesting a good faith estimate. Convening providers and convening facilities shall therefore consider any discussion or inquiry regarding the potential cost of items or services under consideration as a request for a good faith estimate.