Supporting Statement Part-A
Applicable Integrated Plan Coverage Decision Letter
The Bipartisan Budget Act (BBA) of 2018 directed the establishment of procedures to unify Medicare and Medicaid grievance and appeals procedures to the extent feasible for dual eligible special needs plans (D-SNPs) and companion Medicaid managed care organizations beginning in 2021. On April 16, 2019, CMS finalized rules (hereafter referred to as the April 2019 final rule) to implement these new statutory provisions.1 As a result of these regulations, starting in 2021, a subset of fully integrated dual special needs plans (FIDE SNPs) and highly integrated dual special needs plans (HIDE SNPs) and companion Medicaid managed care organizations (i.e., applicable integrated plans) unified and updated appeals and grievance procedures, including how enrollees are notified of their appeal rights.
This information collection request is for the “Applicable Integrated Plan Coverage Decision Letter” or the “coverage decision letter,” which an applicable integrated plan will issue as a result of an integrated organization determination under 42 CFR 422.631 when the applicable integrated plan reduces, stops, suspends, changes or denies, in whole or in part, a request for a service or item (including a Part B drug) or a request for payment of a service or item (including a Part B drug) that the enrollee has already received. “Applicable integrated plans,” are D-SNPs and affiliated Medicaid MCOs with exclusively aligned enrollment that meet the criteria at 42 CFR 422.561. Applicable integrated plans will issue the coverage decision letter in place of the Notice of Denial of Medical Coverage (or Payment) (NDMCP) form (CMS-10003; 0938-0829) as part of requirements to unify appeals and grievance processes. All other Medicare Advantage (MA) plans will continue to use the NDMCP.
We are requesting an revision approval by renewing this information with minor changes to the coverage decision letter to improve readability and reduce confusion. Throughout the letter, we made edits to differentiate between requests for a “Medicare Part B drug” and “Medicaid drug” to ensure clarity for the enrollee. In the second paragraph, we changed the term “partially denied” to “partially approved” for consistency with the Medicare Advantage integrated denial notice. Additionally, in the section titled “There are two kinds of appeals,” we clarified the standard appeal timeframe of 7 calendar days only applies for Medicare Part B drugs the enrollee has not yet received.
Section 1859(f)(8) of the Act requires development of unified grievance and appeals processes for D-SNPs, to the extent feasible. We finalized regulations for integrated organization determinations at § 422.631, affecting D-SNP administration for January 1, 2021 and beyond. The rule requires applicable integrated plans to send an enrollee a written notice of any adverse decision on an integrated organization determination using a notice that is written in plain language and contains the information detailed at § 422.631(d)(1)(iii).
Applicable integrated plans as defined at § 422.561 issue form CMS-10716 when a request for either a medical service or payment is denied in whole or in part after considering both the Medicare and Medicaid benefit. Applicable integrated plans issue this form to enrollees when the plan reduces, stops, suspends, changes, or denies, in whole or in part, a request for a service or item (including a Part B drug) or a request for payment of a service or item (including a Part B drug) that the enrollee has already received. The form provides the enrollee with information regarding their right to an appeal of the applicable integrated plan’s decision and the enrollee will use the instructions to navigate the appeal process.
CMS will not use form CMS-10716 to collect and analyze data on applicable integrated plan appeals.
No data are being collected through this form for analysis; therefore, CMS does not use automated, electronic, mechanical, or other technological collection techniques or other forms of information technology to collect data related to these forms.
The form is available for completion electronically, however, the form must be delivered in writing unless an enrollee opts in to receive notifications via electronic means. Currently, there is no data available to determine how many applicable integrated plan enrollees have chosen to receive notifications electronically and CMS has no current plans to rely on electronic delivery of this form. The form does not require a signature from respondents, so the question of CMS accepting electronic signatures is not applicable.
This information collection does not duplicate any other effort and the information cannot be obtained from any other source. While the purpose for the coverage decision letter is substantially similar to form CMS-10003, we are not able to combine this information collection with CMS-10003 due to potential confusion for MA plans and MA enrollees. The content of the coverage decision letter is for enrollees in a specific subset of MA plans (i.e., applicable integrated plans) and requires different instructions from form CMS-10003. Inclusion of this coverage decision letter with form CMS-10003 could result in MA plans sending the incorrect form to enrollees, potentially causing harm due to an incorrect understanding of their right to file an appeal.
There is no significant impact on small businesses. The form informs enrollees of the right to file an appeal if a request for service or payment is denied in whole or in part.
The statute requires plans to issue written notices to enrollees whenever requests for items/services or payment are denied by Medicare or Medicaid. Thus, there are no opportunities for less frequent collection.
The coverage decision letter is issued by applicable integrated plans when an enrollee’s request for either an item/service or payment is denied in whole or in part. There are no special circumstances to report, and no statistical methods will be employed. More specifically this form:
Does not require respondents to report information to the agency more often than quarterly;
Does not require respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;
Does not require respondents to submit more than an original and two copies of any document;
Does not require respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records for more than three years;
Is not connected with a statistical survey that is not designed to produce valid and reliable results that can be generalized to the universe of study;
Does not require the use of a statistical data classification that has not been reviewed and approved by OMB;
Does not include a pledge of confidentiality that is not supported by authority established in statue or regulation that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
Does not require respondents to submit proprietary trade secret, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
8. Federal Register Notice/Outside Consultation
The 60-day notice published in the Federal Register (90 FR 13367) on March 21, 2025.
We received three comments submitted by two commentors. The first comment requested that we add language to the appeal rights section of the Coverage Decision Letter to align with the National Committee for Quality Assurance guidelines appeal timelines for standard and expedited requests. A second comment recommended that we include the option to use “medical/service item and Medicare Part B drug” throughout the Coverage Decision Letter instead of “medical service/item or Medicare Part B drug”. Changes were made as a result of these comments. The third comment suggested a need to update the timeline for filing appeals. The timeline for filing appeals is correct in the Coverage Decision Letter and therefore we did not make any change related to that comment.
The 30-day notice published in the Federal Register (90 FR 35529) on July 28, 2025.
This collection provides zero payments or gifts to respondents, but it does provide information on why the plan denied the service or payment and informs Medicare enrollees of their appeal rights.
Personally identifiable information contained in the form is protected by the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA) standards for plans and their providers. CMS will not collect data from the forms. Thus, CMS assurance of confidentiality is not applicable to this collection.
Sensitive Questions
No questions of a sensitive nature will be asked.
Burden Estimates
Background
The number of respondents for this collection is based on enrollment for the 129 applicable integrated plans. In January 2025, the enrollment for all applicable integrated plans is 1,163,067.2
To derive average costs, we used data form the U.S. Bureau of Labor Statistics’ May 2024 National Occupation Employment and Wage Estimates for all salary estimates
(http://www.bls.gov/oes/current/oes_nat.htm). In this regard, the following table presents the mean hourly wage, the cost of fringe benefits (calculated at 100 percent of salary), and the adjusted salary wage.
Occupation Title |
Occupation Code |
Median Hourly Wage ($/hr) |
Fringe Benefit ($/hr) |
Adjusted Hourly |
Healthcare Support Workers |
31-9099 |
$22.14 |
$22.14 |
$44.28 |
As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative, and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
We estimate it will take applicable integrated plan staff about 10 minutes (0.1667 hours) to complete the coverage decision letter for denied Medicare and Medicaid services. We base this estimate on an estimate for similar form in CMS-10003.
Only a portion of plan enrollment will require an integrated organization determination. Dual eligible special needs plan reconsideration data does not drill down to show the applicable integrated plan population only. Given the similarity of population characteristics, we used the reconsideration experience for the Medicare-Medicaid Plans (MMPs) participating in the Financial Alignment Initiative as a proxy for the applicable integrated plans. In 2023, 2,647 reconsiderations were resolved adversely or partially favorably to MMP enrollees. The corresponding MMP enrollment in 2023 was 294,386, which implies a rate of 9 reconsiderations per 1,000 in 2023. Applying the MMP reconsideration rate of 9 per 1,000 to the 2025 enrollment in applicable integrated plans of 1,163,067 results in an estimated
10,468 (1,163,067 x 9 / 1,000) service reconsiderations for applicable integrated plans in 2025.
The total annual hourly burden for this collection is 1,745 hours (0.1667 hours x 10,468 forms). The total estimated annual cost for this collection is $77,269 (1,745 hours x $44.28/hr) or $7.38 per form ($77,269 / 10,468 service reconsiderations).
Regulatory Reference |
Respondents |
Total Number of Responses |
Hours Per Response |
Total Hours |
Wages ($/hr) |
Total Cost ($) |
422.631 |
129 AIPs |
10,468 |
0.1667 |
1,745 |
$44.28 |
$77,269 |
There are no capital costs.
14. Cost to the Federal Government
The calculations for CMS employees’ hourly salary were obtained from the Office of Personnel Management 2024 General Schedule Pay Table for the Washington DC Metro area https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2024/generalschedule/.
The annual burden to the Federal Government including the cost of CMS employees’ time is calculated to be: $6,523.
Coverage Decision Letter Review |
|
|
|
Medicare MA, Medicaid CMCS and MMCO D- SNP Subject Matter Experts and staff |
|
Help/Review:5 GS-13 step 5: 5 x $64.06/hr. x 2 hours |
$641 |
1 GS-13 step 5: 1 x $64.06/hr. x 80 hours |
$5,125 |
1 GS-14 step 5: 1 x $75.70/hr. x 10 hours |
$757 |
SUBTOTAL |
$6,523 |
The changes to this collection will have some impact to the burden. Applicable integrated plans will need to make minor changes to the coverage decision letter including updates throughout for consistent language where it refers to Medicare Part B drugs and a clarification to the standard appeal timeframe for Part B drugs not yet received. It is estimated to take an applicable integrated plan of 30 minutes to make these changes to the coverage decision letter.
There is a burden decrease in this collection due to an error made in the data used for the previous package that included adverse, partially favorable, and fully favorable appeal decisions. The data should have only included adverse and partially favorable decisions; thus, the appeal number was higher leading to a higher burden erroneously. We correct for that in this collection in Section 12.
The overall number of applicable integrated plans and enrollees increased. In 2023, there were 112 applicable integrated plans with 810,377 enrollees. In 2025, there are 129 applicable integrated plans with 1,163,067 enrollees. The total number of hours is now 1,745.
The change in cost to the government increased slightly due to the increase in hourly wages. The cost to the government still includes the time of subject matter experts in CMS to update the coverage decision letter, getting feedback from internal CMS departments and creating the Paperwork Reduction Act package.
16. Publication/Tabulation Dates
CMS does not intend to publish data related to the forms.
CMS will display the expiration date and OMB approval number on the coverage decision letter and instructions document.
18. Certification Statement
No exception to any section of OMB Form 83-I is requested.
This collection does not employ statistical methods.
1 See CMS-4185-F, the “Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare
Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid
Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021” final rule. Retrieved from https://www.govinfo.gov/content/pkg/FR-2019-04-16/pdf/2019-06822.pdf.
2 AIP enrollment data from the SNP Comprehensive Report January 2025.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | 2025 Dual Eligible Special Needs Coverage Decision Letter Paperwork Reduction Act Package Supporting Statement |
| Subject | 2024 PRA CDL Supporting Statement |
| Author | CMS/MMCO |
| File Modified | 0000-00-00 |
| File Created | 2025-07-29 |