Marketplace Quality Initiatives FAQs

QHP Issuer Patient Safety

Q1: How can QHP issuers and hospitals meet the patient safety standards requirements outlined in 45 CFR 156.1110 in accordance with the Patient Protection and Affordable Care Act (PPACA) Section 1311(h), specifically since examples noted in the 2017 HHS Payment Notice Final Rule1 (“Final Rule”) such as Hospital Engagement Networks and Quality Improvement Organizations have evolved?2

  • The patient safety requirements outlined in 45 CFR 156.1110 are part of the annual certification requirements for QHPs offered on an Exchange and are intended to be broad and inclusive of various initiatives. We expect hospitals and their partners to determine and engage in the most relevant patient safety strategies for their patient populations.  It is also the responsibility of the QHP issuer and its contracted hospitals to ensure ongoing compliance with the documentation requirement outlined in 45 CFR 156.1110(b)(2). 

    To meet these QHP issuer patient safety requirements, a contracted hospital with greater than 50 beds can contract with a Patient Safety Organization3 (PSO) as specified in 45 CFR 156.1110(a)(2)(i)(A). In addition, CMS previously provided flexibility and established reasonable exceptions to the PSO requirement consistent with section 1311(h)(2) of PPACA.  As clarified in 45 CFR 156.1110(a)(2)(ii), a QHP issuer-contracted hospital could instead implement an evidence-based initiative to improve health care quality through the collection, management and analysis of patient safety events that reduces all-cause preventable harm, prevents hospital readmissions or improves care coordination.

    The QHP issuer patient safety standards are intended to be broad and the reasonable exceptions provision finalized at 45 CFR 156.1110(a)(2)(ii) is intended to be inclusive of various initiatives.  As explained in the Final Rule, we did not intend to provide an exhaustive list of initiatives and instead wanted to allow for flexibility and innovative for future advances in patient safety.4 Some examples of patient safety initiatives identified in the Final Rule that would fall within the reasonable exceptions provision include Hospital Engagement Networks and Quality Improvement Organizations. However, CMS acknowledges that contracts and funding for these specific programs have ended. We reiterate that these were provided as illustrative examples at the time and appreciate some initiatives may have evolved.  However, the reasonable exceptions provision continues to apply and is available to QHP issuers and their contracted hospitals.

    If the hospital contracting with the QHP issuer implements an evidence-based initiative to improve health care quality through the collection, management and analysis of patient safety events that reduces all cause preventable harm, prevents hospital readmissions or improves care coordination, then the requirements outlined in 45 CFR 156.1110(a)(2)(ii) would be met.  QHP issuers and their contracted hospitals also have flexibility in how they comply with the documentation requirement outlined in 45 CFR 156.1110(b)(2). For example, a QHP issuer could demonstrate compliance with this requirement through the collection of current hospital agreements or attestations.5

Quality Rating

Q1: Is an issuer required to report QRS and QHP Enrollee Survey data for a reporting unit (defined by the unique issuer-state-product network type combination) when the issuer makes a change to an existing product that results in the product being offered as a different product network type (e.g., an issuer discontinues their HMO product in 2018 and is offering a POS product in its place in 2019)?

  • As a general matter, per the guaranteed renewability regulations set forth at 45 CFR  147.106, and the definition of product set forth at 45 CFR 144.103, changes to a product offering that result in the product being offered as a different product network type (e.g., health maintenance organization [HMO], preferred provider organization [PPO], exclusive provider organization [EPO], point of service [POS], or indemnity) do not fall within the uniform modification exceptions specified in the regulations identified above, and trigger a discontinuation of the former product. Therefore, if a change occurs that impacts the reporting unit’s product network type, the former product is considered discontinued, and the new product is considered a new offering. States generally are the primary enforcers of these guaranteed renewability and product definition standards, and generally would determine whether a product network type change has occurred, triggering a product discontinuance. CMS recommends QHP issuers work with the state in which their reporting unit(s) operate if they need assistance to determine whether a change in a product’s network type triggering a product discontinuation has occurred.

    For QRS and QHP Enrollee Survey reporting purposes, if a product network type change has not occurred, the QHP issuer would be required to submit QRS and QHP Enrollee Survey data for the POS reporting unit for the 2019 ratings year, and the QHP issuer should review the annual QRS and QHP Enrollee Survey: Technical Guidance available on the Marketplace Quality Initiatives website. If a product network type change triggers a product discontinuation and introduction of a new product, the new product offering will not be required to report data until its second consecutive year of operation through the Exchange, consistent with the regulations at 45 CFR 156.1120(a) and 156.1125(b). Please note, the new product offering will not be eligible to receive a QRS rating until its third consecutive year of operation, per the QRS ratings eligibility criteria described in the annual QRS and QHP Enrollee Survey: Technical Guidance.

Quality Improvement Strategy


Q1: Should an issuer password protect or scan its Quality Improvement Strategy (QIS) Implementation Plan form, Progress Report form, or Modification Summary Supplement prior to submission?

  • No. Issuers should not password protect or scan their QIS Implementation Plan form, Progress Report form, or Modification Summary Supplement prior to submission via the Health Insurance Oversight System (HIOS) or the System for Electronic Rate and Form Filing (SERFF). Issuers should submit their QIS forms as fillable-PDF files, as opposed to files that have been scanned. Password protecting and/or scanning QIS submissions prevents the Centers for Medicare & Medicaid Services (CMS) from processing QIS submissions for evaluation. Issuers who submit scanned and/or password protected QIS forms will be asked to reformat and/or remove password protection and resubmit.

Q2: How does an issuer applying for Qualified Health Plan (QHP) Certification in the Federally-facilitated Exchanges (FFEs) for the upcoming plan year demonstrate compliance with QIS?

  • As specified in 45 C.F.R. §156.1130(c), issuers participating in an Exchange for two or more consecutive years must implement and report on a QIS in a manner and timeframe specified by the Exchange. This includes providing annual updates on their existing quality improvement strategies.

    Issuers participating in the FFEs that submitted a QIS Implementation Plan for a prior plan year are required to submit a QIS Progress Report on their quality improvement strategies for the upcoming plan year. If an issuer is making any modifications to its strategy, the issuer can use the Modification Summary Supplement to indicate any changes to an existing Implementation Plan form on file for the upcoming plan year (e.g., making changes to goals, activities, measures, performance targets, and/or the product types). The issuer must also report progress on their current QIS using the separate QIS Progress Report form.

    Additional details on the QIS submission requirements, participation criteria, and timeline can also be found in the QIS Guidance.

    At this time, issuers participating in the FFEs will not be penalized for failure to meet their performance targets. However, each issuer should strive to achieve progress toward meeting the goals and corresponding performance targets specified in its QIS. Issuers will also not be penalized if they need to adjust the timelines or redefine the milestones in an existing QIS.

Q3: How often will an issuer’s minimum enrollment threshold be calculated?

  • Minimum enrollment is assessed prior to the third year in which an issuer would be reporting on progress on their QIS. Minimum enrollment is also assessed prior to the sixth year in which an issuer would reporting on progress for a particular QIS. If an issuer closes out a QIS prior to the third year of progress reporting, the minimum enrollment will be assessed prior to the third year of progress reporting on the new QIS.
Issuers must provide two consecutive years of progress updates if they are continuing their QIS, regardless of whether these issuers’ product type(s) meet the minimum enrollment threshold. Issuers may discontinue progress reporting if their product type(s) no longer meet the minimum enrollment threshold prior to the third consecutive year of progress reporting.

Q4: What is the QIS evaluation timeline and process?

  • CMS will evaluate QIS submissions according to the timeline for QHP Certification in the FFEs described in the annual Letter to Issuers. Per the current QHP Certification timeline, there are two review periods during the QHP Application submission and review period (QHP Application Period), during which the FFEs, including FFEs where States perform plan management, evaluate issuers’ QIS submissions.

    QIS submissions received during the QHP Application Period will be assessed for completeness. Issuers whose submissions contain blank fields or are missing information will receive correction notices after the first round of QHP Application review indicating which fields were missing information. Issuers that receive correction notices identifying QIS deficiencies must correct and resubmit their QIS Implementation Plan form, Progress Report form, and Modification Summary Supplement, if applicable, during the subsequent review period. Issuers whose resubmissions contain missing info or blank fields after the second round of review will not receive second correction notices but will be notified of potential concerns during the Post-Certification Assessment (PCA) period.

    Issuers that met the QIS participation criteria, but did not submit at least one QIS as expected, will receive a correction notice after the first round of review.  If they do not submit a QIS form during the subsequent review period, they will receive a second correction notice.

    Issuers will not be notified if their QIS submissions are assessed as complete during the QHP Application period. Issuers will not be notified if their QIS submissions receive an overall outcome of “Meets” during the PCA period.

Q5: How should an issuer respond to Element 16 in the QIS Implementation Plan and Element 15 in the Progress Report form if its percentage of any payment model is greater than 0%, but less than 1%?

Q6: Does an issuer need to submit a separate QIS for each eligible product type (e.g. Health Maintenance Organizations (HMOs), Preferred Provider Organizations (PPOs), Point of Service (POS) plans, Exclusive Provider Organizations (EPOs), and indemnity plans) within an Exchange?

  • No. An issuer may choose to implement a single QIS to cover all of its eligible health plans and product types or may choose to implement multiple quality improvement strategies.

Q7: Can the QIS Implementation Plan form, Progress Report form, and Modification Summary Supplement be submitted independently of the larger QHP Application?

  • Issuers should submit their QIS Implementation Plan form, Progress Report form, and Modification Summary Supplement as part of QHP Certification, when they submit their QHP Applications. Submission instructions related to the QHP Application and QIS Implementation Plan form, Progress Report form, and Modification Summary Supplement may vary by Exchange. For example, issuers operating in FFE States will submit via HIOS. Issuers operating in FFEs where States perform plan management will submit via SERFF. Issuers operating in State-based Exchanges (SBEs) or SBEs on the Federal Platform (SBE-FPs) should contact their Exchange for specific instructions on QHP Application submission, including QIS submission. 

Q8: Should an issuer use its Quality Rating System (QRS) measures as its QIS baseline data in Element 25 of the QIS Implementation Plan, Element 16 of the Progress Report form, and Element 8 of the Modification Summary Supplement?

  • Issuers are not required to use QRS measures for their QIS baseline data. Issuers may choose to use QRS measures or may choose to use other data sources that identify QHP enrollee population needs and support their QIS rationale for their QIS baseline data in Element 25 of the QIS Implementation Plan, Element 16 of the Progress Report form, and Element 8 of the Modification Summary Supplement.

Q9: What is QIS baseline data?

  • Baseline assessment results should measure an issuer’s performance before beginning the QIS and serve as a basis for comparison with results for the same measure in subsequent years. When reporting on progress, issuers should use the data from their initial QIS Implementation Plan if they have not modified their measures. 

Q10: For issuers in FFE States, including FFEs where States perform plan management, what happens to issuers' QIS Implementation Plan form, Progress Report form, and Modification Summary Supplement following submission during QHP Certification?

  • For issuers in FFE States, including FFEs where States perform plan management, QIS forms submitted during QHP Certification are first assessed for completeness, and then undergo full evaluation by CMS.

    Issuers participating in the FFEs whose QIS forms were not received as required, were missing information, or contained blank fields receive correction notices during QHP Certification that specify any QIS deficiencies. Issuers participating in the FFEs that receive correction notices must correct and resubmit their QIS forms.

    If issuers participating in the FFEs do not receive correction notices that list QIS deficiencies, their QIS forms are complete and will undergo full evaluation.

    For issuers in FFEs where States perform plan management, the submission is jointly reviewed by CMS and the State, with the final determination being made by CMS. Issuers operating in these States should contact the State for details on the State's process for evaluating QIS submissions.

Q11: When will CMS notify issuers operating in FFE States, including FFEs where States perform plan management, of their full QIS evaluation results?

  • CMS notifies issuers in FFE States, including FFEs where States perform plan management, of any concerns with their QIS submissions based on their full QIS evaluation results at the end of the calendar year during the PCA Period, which occurs after the conclusion of the annual QHP Certification Period in which the QIS submissions were made.

    An issuer participating in an FFE that receives outreach regarding potential concerns with its QIS must work with CMS to address these concerns.

    CMS does not provide affirmative notification of fulfillment of the QIS requirements. Issuers participating in the FFEs that do not receive notification of potential concerns by the end of the calendar year following the conclusion of the applicable QHP Certification cycle should continue their QIS implementation.

    For issuers in FFEs where States perform plan management, the submission is jointly reviewed by CMS and the State, with the final determination being made by CMS. Issuers operating in these states should contact the State for details on the State's process for evaluating QIS submissions.


1Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2017, Final Rule, 81 FR 12204 (March 8, 2016), available at: https://www.federalregister.gov/documents/2016/03/08/2016-04439/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2017.
2The contents of this FAQ do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.  This information is intended only to provide clarity to the public regarding existing requirements under the law.
3Patient Safety and Quality Improvement Act (42 U.S. Code § 299b–21) which defines a patient safety evaluation system(the collection, management or analysis of information for reporting to or by a PSO). The listed PSOs are available at https://www.pso.ahrq.gov/pso.
4See 81 FR at 12316.
5Id.