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Federal Register / Vol. 86, No. 177 / Thursday, September 16, 2021 / Proposed Rules
random or targeted investigations of providers and facilities. This would allow CMS to proactively identify and address issues of non-compliance, and it would generally align CMSs enforcement procedures with respect to providers and facilities with those applicable to non-Federal governmental plans and issuers under newly proposed 45 CFR 150.303c, but would exclude any reference to market conduct examinations, as these are typically used in connection with group health plans and health insurance issuers, and not with providers.
HHS proposes to codify in 45 CFR
150.503d the statutory language, located at section 1128Ak of the SSA
and included via section 2799B4 of the PHS Act, that allows HHS to bring an action to prevent a provider or facility from engaging in activity that would make the provider or facility subject to a civil money penalty. HHS also proposes that CMS may bring an action to prevent a provider or facility from concealing, removing, encumbering, or disposing of assets that may be required in order to pay any civil money penalty that might be imposed or to seek other appropriate relief.
23. Notice to Responsible Entities 45
CFR 150.505
HHS proposes to specify in 45 CFR
150.505 that if CMS receives information that indicates a possible violation, or selects a provider or facility for investigation, or fails to receive data required in 45 CFR 149.460, CMS would provide a written notice to the provider or facility. The notice would describe the information that prompted the investigation or notify the provider or facility that it was selected for investigation. The notice would also state that a civil money penalty may be assessed, and that CMS may require a plan of corrective action. The notice would provide the date by which the provider or facility must respond with additional information, including documentation of compliance. In the case of a provider of air ambulance services, this could include a date by which the provider of air ambulance services would be required to submit any missing information from the report required under 45 CFR 149.460. HHS
anticipates that CMS would generally provide 14 days for providers and facilities to respond to the notice with the requested documentation. This would provide sufficient time for a recipient to investigate the substance of an allegation and respond to CMS. HHS
anticipates that the documentation or information necessary to respond to most complaints should be readily
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available to a provider for example, in the form of computerized patient billing records, etc.. A 14-day window for response should provide sufficient time to gather this documentation and formulate a response. In circumstances that warrant a more rapid response, such as complaints involving urgent medical issues or allegations of fraud and abuse, CMS may shorten the time frame for the provider or facility to provide the requested documentation but does not anticipate requesting responses within less than 24 hours.
24. Request for Extension 45 CFR
150.507
HHS proposes to provide in 45 CFR
150.507 that if a provider or facility received a notice of possible violation from CMS, and the provider or facility could not prepare a response by the deadline provided in the notice under 45 CFR 150.505, such provider or facility may make a written request for an extension. The request must detail the reason for the extension request and must show good cause. Examples of what CMS would consider good cause include, but are not limited to, when a responsible entity indicates it has limited staffing resources to prepare a response, or when a responsible entity requests clarification from CMS
regarding its request for information. If CMS grants the extension, the provider or facility would be required to respond within the specified time frame. Failure to respond within the time allotted would result in CMS initiating an action to impose a civil money penalty.
25. Responses to Notice of Potential Violations 45 CFR 150.509
HHS proposes to provide in 45 CFR
150.509 that CMS would consider all relevant documentation provided when determining whether to impose a civil money penalty, including information from the complainant and information from the provider or facility. In responding to an allegation of noncompliance, a provider or facility may submit medical bills; notice and consent forms signed by the participant, beneficiary, or enrollee or an authorized representative; proof of public disclosure of patient protections against balance billing; or any other evidence of compliance.
In 45 CFR 150.509d, HHS proposes that a provider or facility may also submit to CMS any evidence documenting the development and implementation of internal policies and procedures to ensure compliance with the PHS Act and section 106a of the No Surprises Act, as applicable. One example would be a voluntary
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compliance program. A voluntary compliance program should, at a minimum: Effectively articulate and demonstrate the fundamental mission of compliance and the provider or facilitys commitment to the compliance process; include the name of the individual in the organization who is responsible for compliance; include an effective monitoring system to identify practices that do not comply with PHS
Act requirements or section 106a of the No Surprises Act, as applicable, and to provide reasonable assurance that violations are detected in a timely manner; and address procedures to improve internal policies when noncompliant practices are identified.
In 45 CFR 150.509e, HHS proposes that a provider or facility may respond to an allegation of noncompliance by submitting evidence documenting the provider or facilitys record of previous compliance with PHS Act requirements or section 106a of the No Surprises Act, as applicable. Examples of previous compliance would include copies of signed notice and consent forms or prominently displayed disclosures of patient protections against balance billing.
Section 106e2 of the No Surprises Act provides that HHS may waive a penalty when a provider of air ambulance services submits only some of the data required in section 106a of the No Surprises Act if the provider of air ambulance services makes a good faith effort to submit the missing data.
In 45 CFR 150.509f, HHS proposes that such a provider can exhibit a good faith effort by submitting and implementing a corrective action plan that: i Identifies the cause underlying the submission of incomplete data and effectively articulates and demonstrates the measures that would be taken to submit complete data; ii provides the timeline for submitting complete data; iii provides the name of the individual in the organization responsible for overseeing corrective actions and submitting complete data; and iv addresses procedures to improve internal policies to ensure that incomplete data reports are identified and completed prior to submission for future reporting periods. HHS is of the view that these elements would demonstrate that a provider of air ambulance services is committed to identifying and correcting any errors that prevented it from submitting the complete set of data required. HHS
seeks comment on this proposal.

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