Federal Register - October 7, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 192 / Thursday, October 7, 2021 / Rules and Regulations iii Notice of the additional requirements for providers or facilities specified in paragraphs c5 and 6 of this section while the patient-provider dispute resolution process is pending;
and iv Information to the uninsured or self-pay individual about the availability of consumer assistance resources that can assist the individual with the dispute.
4 Validation of initiation notice.
After the selection of the SDR entity, as described in paragraph c2 of this section, the SDR entity shall review the initiation notice to ensure the items or services in dispute meet the eligibility criteria described in paragraph b of this section and the initiation notice contains the required information described in paragraph c2. The SDR
entity will notify the uninsured or selfpay individual of the outcome of the review, including, if applicable, providing the individual with 21
calendar days to submit supplemental information when the initiation notice is determined to be incomplete or the items or services are determined ineligible for dispute resolution.
i If the SDR entity determines that the item or service meets the eligibility criteria, and the initiation notice contains the required information, the SDR entity will notify the uninsured or self-pay individual and the provider or facility that the that the item or service has been determined eligible for dispute resolution. The SDR entity shall request the provider or facility provide the information described in paragraph f2 of this section within 10 business days.
ii If the SDR entity determines that the item or service does not meet the eligibility criteria or that the initiation notice does not contain the required information, the SDR entity will provide an insufficiency notice to the uninsured or self-pay individual of the determination and the reasons for the determination and will notify the uninsured or self-pay individual that the individual may submit supplemental information, postmarked within 21 calendar days, to resolve any deficiencies identified. If the insufficiency notice is not made available to an individual in a format that is accessible to individuals with disabilities or with low-English proficiency within 14 calendar days of such a request from the individual, a 14calendar-day extension will be granted so that the individual will have a total of 35 calendar days to submit supplemental information.
5 Prohibitions on collections. While the patient-provider dispute resolution
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process is pending, the provider or facility must not move the bill for the disputed item or service into collection or threaten to do so, or if the bill has already moved into collection, the provider or facility should cease collection efforts. The provider or facility must also suspend the accrual of any late fees on unpaid bill amounts until after the dispute resolution process has concluded.
6 Prohibitions on retributive action.
The provider or facility must not take or threaten to take any retributive action against an uninsured or self-pay individual for utilizing the patientprovider dispute resolution process to seek resolution for a disputed item or service.
d Certification of SDR entities1
In general. The Secretary shall contract with and certify only that number of SDR entities the Secretary believes will be necessary to timely resolve the volume of patient-provider disputes. As part of the contract process with HHS, a potential SDR entity must satisfy the Federal IDR entity certification criteria specified in 149.510e, subject to the exceptions set forth in paragraphs d2
of this section. In addition, the SDR
entity must also meet the conflict-ofinterest mitigation policy requirements specified in paragraph d3 of this section. Through this contract process, HHS will assess the dispute resolution entity for compliance with all applicable SDR entity certification requirements.
2 Exception for SDR entity certification. With respect to certified IDR entity requirements that do not apply to an SDR entity, potential SDR
entities are not required to make the following submissions:
i Information regarding the service areas for which the entity will arbitrate cases, however, a potential SDR entity will need to submit information on their ability to operate nationwide through the contract process;
ii Fee schedule for batched and nonbatched claims;
iii Policies and procedures to hold dispute resolution entity fees in a trust or escrow account, however, a potential SDR entity must submit policies and procedures to hold administrative fees, as described in paragraph g of this section, and remit them to HHS in a manner specified by HHS.
3 Conflict of interest mitigation policies. A potential SDR entity must also provide additional information on the SDR entitys conflict-of-interest policies and procedures, including outlining a mitigation plan in the event of an entity-level conflict of interest, under which no dispute resolution
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personnel affiliated with the SDR entity can fairly and impartially adjudicate a case, in compliance with the standards in Federal Acquisition Regulationsubpart 9.5 48 CFR subpart 9.5. Such conflict of interest mitigation plan could include utilizing a subcontractor without a conflict of interest that meets SDR entity requirements to conduct the patient-provider dispute resolution for the case.
e Selection of an SDR entity. 1
After the Secretary has received the initiation notice as described in paragraph c of this section, the Secretary will assign an SDR entity that is certified and contracted under paragraph d of this section to conduct the dispute resolution process for the item or service. Upon receiving an assignment from the Secretary to make a determination for an item or service as described in paragraph c3 of this section, the SDR entity shall ensure that no conflict of interest exists, and in such case, shall notify the uninsured or selfpay individual and the provider or facility of the selection of the SDR
entity.
2 Should a conflict of interest exist, the SDR entity must submit notice to the Secretary of such conflict no later than 3 business days following selection by the Secretary. The Secretary will then automatically select a new SDR entity to conduct the patient-provider dispute resolution process for the item or service. In the event that no SDR entities are available to resolve the dispute, the initially-selected SDR entity will be required to initiate their entity-level conflict of interest mitigation plan as described in paragraph d3 of this section. If no other contracted SDR
entity, and no subcontracted entity, is able to provide the patient-provider dispute resolution services due to conflicts of interest that cannot be sufficiently mitigated or any other reason, HHS may seek to contract with an additional SDR entity as needed. In the event that HHS needs to contract with an additional SDR entity, the time periods specified in this section may be extended at HHS discretion to allow for HHS to contract with that SDR entity.
3 Conflict of interest means, with respect to a party to a payment determination, or SDR entity, a material relationship, status, or condition of the party, or SDR entity that impacts the ability of the SDR entity to make an unbiased and impartial payment determination. For purposes of this section, a conflict of interest exists when an SDR entity is:
i A provider or a facility;
ii An affiliate or a subsidiary of a provider or facility;
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