CMS-10558 - Supporting Statement

Supporting Statement for Machine Readable Data for Provider Network and Prescription Formulary Content for FFM QHPs

(CMS-10558/OMB control number: 0938-1284)

1. Background

On March 23, 2010, the Patient Protection and Affordable Care Act (PPACA; P.L. 111-148) was signed into law and on March 30, 2010, the Health Care and Education Reconciliation Act of 2010 (P.L. 111-152) was signed into law. The two laws implement various health insurance policies.

45 C.F.R. § 156.122(d)(1)-(2) and 156.230(b)-(c) as finalized in the rule, the Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2018 (CMS-9934-F), established standards for qualified health plan (QHP) issuers for the submission of provider and formulary data in a machine-readable format to the Department of Health and Human Services (HHS) and for posting the data on issuer websites. These standards provide greater transparency for consumers, including by allowing software developers to access formulary and provider data to create innovative and informative tools. On September 30, 2015, the Office of Management and Budget (OMB) granted approval to the data collection Information Collection for Machine Readable Data for Provider Network and Prescription Formulary Content for FFE QHPs under OMB control number 0938-1284. OMB approval was granted again on November 3, 2017 and March 22, 2021. The Centers for Medicare and Medicaid Services (CMS) is continuing that information collection request (ICR) in connection with these machine-readable standards.

2. Justification

1. Need and Legal Basis

Issuers are required to produce certain data to CMS in a machine-readable format to increase and enhance transparency of QHP drug formulary information and of information about providers under health plans. Under 45 C.F.R. § 156.122(d), QHP issuers, including Small Business Health Options Program (SHOP) issuers but excluding stand-alone dental plans (SADP) issuers, are required to publish an up-to-date, accurate, and complete list of all covered drugs, known as formularies.¹ Section 156.122(d)(1) states that formularies must list all drugs that fall under the category of essential health benefits (EHB), and list all drug names currently covered by the plan. Issuers must provide complete, accurate, and up-to-date formulary information for consumers on their website and must update this information not less than monthly. Further, §156.122(d)(2) requires that QHP issuer in the Federally-facilitated Exchanges (FFE) publish their formulary drug list on its website in an HHS-specified format and submit this information to HHS in a format and at times determined by HHS. The machine-readable file or a format specified by HHS increases transparency by allowing software developers to access this information to create innovative and informative tools to help enrollees better understand plans’ drug lists. QHP issuers must update the drug information in a machine-readable format not less than monthly. QHP issuers must submit drug information by “RxNorm Concept Unique Identifier” (RxCUI), including all drug formulations covered.

In addition, 45 C.F.R. § 156.230(b)(1)-(2) requires QHP issuers, including Small Business Health Options Program (SHOP) issuers and stand-alone dental plans (SADP) issuers, to publish an up-to-date, accurate, and complete provider directory, including information on which providers are accepting new patients, the provider’s location, contact information, specialty, medical group, and any institutional affiliations, in a manner that is easily accessible to plan enrollees, prospective enrollees, States, the Exchange, CMS, and the Office of Personnel Management (OPM). Section 156.230(b)(2) specifies that an issuer must update the directory information at least once a month. Section 156.230(c) requires issuers to make information about providers in its provider networks available to HHS in a specified format at times determined by HHS, and to make the information available on their websites. Additionally, under the No Surprises Act section 116 (H.R. 133, Public Law 116-260), Internal Revenue Code section 9820(a) and (b), ERISA section 720(a) and (b), and PHS Act section 2799A-5(a)

and (b), group health plan or health insurance issuer offering group or individual health insurance coverage shall establish a database and provider directory information on a public website of each plan or issuer that contains a list of each health care provider and health care facility with which the plan or issuer has a director or indirect contractual relationship. The provider directory information includes the name, address, specialty telephone number, and digital contact information of each health care provider or facility with which the plan or issuer has a contractual relationship furnishing items or services.

The machine-readable file increases transparency by allowing software developers to access formulary and provider data, to create innovative and informative tools to assist enrollees in understanding plans’ provider networks.

2. Information Uses

Software developers and CMS access this information to create and maintain tools to help enrollees better understand the availability of drugs and providers in a specific plan.

3. Use of Information Technology

The availability of provider and formulary information aids consumers in efficiently selecting and using their QHP benefits.

Establishing machine-readable files with this data provides the opportunity for third parties to create resources that aggregate information on different plans and thus improve transparency.

4. Duplication of Efforts

We anticipate no duplication of effort for issuers. There are no other federal requirements that would require QHP issuers to provide provider directory and drug formulary information in a machine-readable format.

5. Small Business

This information collection will not have a significant impact on small businesses.

6. Less Frequent Collection

The burden associated with this information collection consists of QHP issuers updating provider and formulary information, which QHP issuers are required to make available to consumers and to CMS not less than monthly. Because provider contracts and formularies change frequently, a less frequent information collection increases inaccuracy of data over time.

7. Special Circumstances

There are no special circumstances.

8. Federal Register/Outside Consultation

A 60-day notice was published in the Federal Register on November 3, 2023 (88 FR 75597) for the public to submit written comment on the information collection requirements. No public comments were received.

A 30-day notice published in the Federal Register on March 27, 2024 (89 FR 21254) for the public to submit written comment on the information collection requirements.

No additional outside consultation was sought.

9. Payments/Gifts to Respondents

No payments and/or gifts will be provided to respondents.

10. Confidentiality

To the extent of the applicable law and HHS policies, we will maintain consumer privacy with respect to the information disclosed.

11. Sensitive Questions

There are no sensitive questions included in this information collection effort.

12. Burden Estimates (Hours & Wages)

Average labor costs (including 100 percent fringe benefits) used to estimate the costs are calculated using data available from the May 2022 National Industry-Specific Occupational Employment and Wage Estimates (Bureau of Labor Statistics (BLS) (https://www.bls.gov/oes/current/oes_nat.htm#11-0000). The adjusted median hourly wages applicable to this ICR are provided in Table 1.

Table 1: Adjusted Hourly Wages Used in Burden Estimates

Occupation Title	Occupational Code	Median Hourly Wage ($/hour)	Fringe Benefits & Overhead (100%)($/hour)	Adjusted Hourly Wage ($/hour)
Pharmacist	29-1051	$63.82	$63.82	$127.64
Operations Research Analyst/ Health Policy Analyst1	15-2031	$41.21	$41.21	$82.42
Computer Programmer	15-1251	$47.02	$47.02	$94.04
General and Operations (Senior) Manager	11-1021	$47.16	$47.16	$94.32

¹ As with prior versions of this ICR, the Health Policy Analyst wage (which no longer has an OES designation in the BLS OES wage estimates) is estimated to be equivalent to that of an Operations Research Analyst, Occupational Code 15-2031.

The following section contains an estimate of the burden imposed by the associated ICRs. The burden estimates reflect the time and effort for QHP and SADP issuers to update and publish the appropriate data and submit it to CMS.

We estimate 219 QHP issuers will be subject to the requirement to update and publish both provider directory data and formulary data monthly, and submit it to CMS, based on the number of issuers that were approved to offer QHPs in the 2024 plan year. We estimate that 215 SADP issuers will be subject to the requirement to update and publish only provider directory data monthly and submit it to CMS, based on the number of issuers that were approved to offer SADPs in the 2024 plan year. Information regarding the data fields that we propose issuers provide is contained in Appendix A, which is also posted on: https://developer.cms.gov/marketplace-api/coverage-portal/#/schema. Issuers will report their URLs annually and communicate their URLs for their JSON file locations through an online submission form located at the MarketPlace Plan Management System (MPMS). MPMS Issuer Details content can also be found in Appendix B.

We estimate that about 28 new QHP issuers will need to fulfill the formulary and provider directory monthly data requirements for the first time each year of this ICR, based on the rate of new issuers entering the marketplace in prior years. Table 2a displays the burden for the new QHP issuers in their first year on the Exchange relating to these regulatory requirements. We estimate that that the hours required to complete the monthly data requirements for all 12 months of a new QHP issuer’s first year in the marketplace will be as follows: it will take a pharmacist 8 hours (at $127.64 per hour), a health policy analyst 28 hours (at $82.42 per hour), an operations research analyst 2 hours (at $82.42 per hour), a computer programmer 94 hours (at $94.04 per hour), and a senior manager 4 hours (at $94.32 per hour). The total estimated burden per new QHP issuer per year is $12,710.76 and 136 hours. For all new QHP issuers in a given year, the total estimated burden is $355,901.28 and 3,808 hours.

Pursuant to 45 C.F.R. 156.230(c), QHP issuers, including new QHP issuers, must publish and update provider directory data in the machine readable format directed by CMS, on a monthly basis. In addition, 45 C.F.R. 156.122(d)(1)-(2) requires QHP issuers, including new QHP issuers, to publish and update formulary data in a machine readable format designated by CMS, on a monthly basis.

Table 2a: Total Annual Burden to New QHP Issuers (N=28) in their First Year

Labor Category	Number of Respondents	Hourly Labor Costs (Hourly Wage Rate + 100% Fringe benefits)	Burden Hours (per Respondent)	Total Burden Costs (per Respondent)	Total Burden Cost (All Respondents)
Pharmacist	1	$127.64	8	$1,021.12	$28,591.36
Health Policy Analyst1	1	$82.42	28	$2,307.76	$64,617.28
Operations Research Analyst	1	$82.42	2	$164.84	$4,615.52
Computer Programmer	1	$94.04	94	$8,839.76	$247,513.28
Senior Manager	1	$94.32	4	$377.28	$10,563.84
Total			136	$12,710.76	$355,901.28

¹ As with prior versions of this ICR, the Health Policy Analyst wage (which no longer has an OES designation in the BLS OES wage estimates) is estimated to be equivalent to that of an Operations Research Analyst, Occupational Code 15-2031.

We estimate that about 11 new SADP issuers will need to fulfill the provider directory monthly data requirements for the first time each year of this ICR, based on the rate of new issuers entering the marketplace in prior years. We estimate that the hours required to complete the monthly data requirements for all 12 months of a new SADP issuer’s first year in the marketplace will be as follows: it will take a health policy analyst 14 hours (at $82.42 per hour), an operations research analyst one hour (at $82.42 per hour), a computer programmer 47 hours (at $94.04 per hour), and a senior manager 2 hours (at $94.32 per hour) for new SADPs to fulfill these requirements in the first year. The total estimated burden per new SADP issuer per year is $5,844.82 and 64 hours. For all new SADP issues in a given year, the total estimated burden is $64,293.02 and 704 hours.

Pursuant to 45 C.F.R. 156.230(c), SADP issuers, including new SADP issuers, must publish and update provider directory data in the machine readable format directed by CMS, on a monthly basis. Table 2b displays the burden for the new SADP issuers in their first year on the Exchange relating to this regulatory requirement.

Table 2b: Total Annual Burden to New SADP Issuers (N=11) in their First Year

Labor Category	Number of Respondents	Hourly Labor Costs (Hourly rate + 100% Fringe benefits)	Burden Hours (per Respondent)	Total Burden Costs (per Respondent)	Total Burden Cost (All Respondents)
Health Policy Analyst1	1	$82.42	14	$1,153.88	$12,692.68
Operations Research Analyst	1	$82.42	1	$82.42	$906.62
Computer Programmer	1	$94.04	47	$4,419.88	$48,618.68
Senior Manager	1	$94.32	2	$188.64	$2,075.04
Total			64	$5,844.82	$64,293.02

¹ As with prior versions of this ICR, the Health Policy Analyst wage (which no longer has an OES designation in the BLS OES wage estimates) is estimated to be equivalent to that of an Operations Research Analyst, Occupational Code 15-2031.

We estimate that 210 existing QHP issuers will have the infrastructure in place to fulfill the provider directory and formulary monthly data requirements across the first year of data collection under this ICR. For each existing QHP issuer, we estimate that it will take a health policy analyst 18 hours per year (at $82.42 per hour) and a computer programmer 18 hours per year (at $94.04 per hour) to fulfill these requirements. The total estimated burden for existing QHP issuers in Year 1 is $3,176.28and 36 hours. For all existing QHP issuers in Year 1, the total estimated burden is $667,018.80 and 7,560 hours.

Pursuant to 45 C.F.R. 156.230(c), QHP issuers must publish and update provider directory data in the machine readable format directed by CMS, on a monthly basis. In addition, 45 C.F.R. 156.122(d)(1)-(2) requires QHP issuers to publish and update formulary data in a machine readable format as designated by CMS, on a monthly basis. Table 3a displays the burden for existing QHP issuers relating to these regulatory requirements. 

Table 3a: Total Annual Burden to Existing QHP Issuers (N=210) in Year 1

Labor Category	Number of Respondents	Hourly Labor Costs (Hourly rate + 100% Fringe benefits)	Burden Hours (per Respondent)	Total Burden Costs (per Respondent)	Total Burden Cost (All Respondents)
Health Policy Analyst1	1	$82.42	18	$1,483.56	$311,547.60
Computer Programmer	1	$94.04	18	$1,692.72	$355,471.20
Total			36	$3,176.28	$667,018.80

¹ As with prior versions of this ICR, the Health Policy Analyst wage (which no longer has an OES designation in the BLS OES wage estimates) is estimated to be equivalent to that of an Operations Research Analyst, Occupational Code 15-2031.

We estimate that 197 existing SADP issuers will have the infrastructure in place to fulfill the provider directory monthly data requirements across the first year of data collection under this ICR. For each existing SADP issuer, we estimate that it will take a health policy analyst 9 hours per year (at $82.42 per hour) and a computer programmer 9 hours per year (at $94.04 per hour) to fulfill these requirements. The total estimated burden for existing SADP issuers in Year 1 is $1,588.14 and 18 hours. For all existing SADP issuers in Year 1, the total estimated burden is $312,863.58 and 3,546 hours.

Pursuant to 45 C.F.R. 156.230(c), SADP issuers must publish and update provider directory data in the machine readable format directed by CMS, on a monthly basis. Table 3b displays the burden for existing SADP issuers relating to this regulatory requirement.

Table 3b: Total Annual Burden to Existing SADP Issuers (N=197) in Year 1

Labor Category	Number of Respondents	Hourly Labor Costs (Hourly rate + 100% Fringe benefits)	Burden Hours (per Respondent)	Total Burden Costs (per Respondent)	Total Burden Cost (All Respondents)
Health Policy Analyst1	1	$82.42	9	$741.78	$146,130.66
Computer Programmer	1	$94.04	9	$846.36	$166,732.92
Total			18	$1,588.14	$312,863.58

¹ As with prior versions of this ICR, the Health Policy Analyst wage (which no longer has an OES designation in the BLS OES wage estimates) is estimated to be equivalent to that of an Operations Research Analyst, Occupational Code 15-2031.

In years two and three, we estimate that it will take a health policy analyst 18 hours per year (at

$82.42 per hour) and a computer programmer 18 hours per year (at $94.04 per hour) to fulfill the provider directory and formulary data requirements for each QHP issuer. This is a total estimated burden of $3,176.28 and 36 hours per issuer per year in each of these two years, or $695,605.32 and 7,884 hours in each of these two years for all 219 QHP issuers. Thus, the total burden in years 2 and 3, combined, for all 219 QHP issuers is $1,391,210.64 and 15,768 hours.

Pursuant to 45 C.F.R. 156.230(c), QHP issuers, including QHP issuers in years two and three on the Exchange, must publish and update provider directory data in the machine readable format directed by CMS, on a monthly basis. In addition, 45 C.F.R. 156.122(d)(1)-(2) requires QHP issuers to publish and update formulary data in a machine readable format designated by CMS, on a monthly basis. Table 4a displays the burden for QHP issuers in years two and three on the Exchange relating to these regulatory requirements. 

Table 4a: Total Annual Burden to QHP Issuers (N=219) in Year 2 and Year 3

Labor Category	Number of Respondents	Hourly Labor Costs (Hourly rate + 100% Fringe benefits)	Burden Hours (per Respondent)	Total Burden Costs (per Respondent)	Total Burden Cost (All Respondents)
Health Policy Analyst1	1	$82.42	18	$1,483.56	$324,899.64
Computer Programmer	1	$94.04	18	$1,692.72	$370,705.68
Total			36	$3,176.28	$695,605.32

¹ As with prior versions of this ICR, the Health Policy Analyst wage (which no longer has an OES designation in the BLS OES wage estimates) is estimated to be equivalent to that of an Operations Research Analyst, Occupational Code 15-2031.

In years two and three, we estimate that it will take a health policy analyst 9 hours per year (at $82.42 per hour) and a computer programmer 9 hours per year (at $94.04 per hour) to fulfill the provider directory data requirements for each SADP issuer. This is a total estimated burden of $1,588.14 and 18 hours per issuer per year in each of these two years, or $341,450.10 and 3,870 hours in each of these two years for all 215 SADP issuers. Thus, the total burden in years 2 and 3, combined, for all 215 SADP issuers is $682,900.20 and 7,740 hours.

Pursuant to 45 C.F.R. 156.230(c), SADP issuers, including SADP issuers in years two and three on the Exchange, must publish and update provider directory data in the machine readable format directed by CMS, on a monthly basis. Table 4b displays the burden for the SADP issuers in years two and three on the Exchange relating to this regulatory requirement.

Table 4b: Total Annual Burden to SADP Issuers (N=215) in Year 2 and Year 3

Labor Category	Number of Respondents	Hourly Labor Costs (Hourly rate + 100% Fringe benefits)	Burden Hours (per Respondent)	Total Burden Costs (per Respondent)	Total Burden Cost (All Respondents)
Health Policy Analyst1	1	$82.42	9	$741.78	$159,482.70
Computer Programmer	1	$94.04	9	$846.36	$181,967.40
Total			18	$1,588.14	$341,450.10

¹ As with prior versions of this ICR, the Health Policy Analyst wage (which no longer has an OES designation in the BLS OES wage estimates) is estimated to be equivalent to that of an Operations Research Analyst, Occupational Code 15-2031.

The aggregate cost for years one through three across all 434 issuers is $3,474,187.52($1,400,076.68 in year one + $1,037,055.42 x 2 for years two and three). The total burden hours across all 434 issuers is 39,126 hours (15,618 hours in year one + 23,508 for years two and threes).

Table 5 provides a summary of the estimates within this package.

Table 5: Summary of Total Annual Burden

Table Number: Name	CFR Section	Burden Hours	Burden Cost
Table 2a: New QHP Issuers in First Year	45 C.F.R. § 156.122(d)(1)-(2) and 156.230(c)	3,808	$355,901.28
Table 2b: New SADP Issuers in First Year	45 C.F.R. § 156.230(c)	704	$64,293.02
Table 3a: Existing QHP Issuers in Year 1	45 C.F.R. § 156.122(d)(1)-(2) and 156.230(c)	7,560	$667,018.80
Table 3b: Existing SADP Issuers in Year 1	45 C.F.R. § 156.230(c)	3,546	$312,863.58
Table 4a: QHP Issuers in Years 2 and 3 (both years combined)	45 C.F.R. § 156.122(d)(1)-(2) and 156.230(c)	15,768	$1,391,210.64
Table 4b: SADP Issuers in Years 2 and 3 (both years combined)	45 C.F.R. § 156.230(c)	7,740	$682,900.20
Total		39,126	$ 3,474,187.52

13. Capital Costs

There are no additional capital costs associated with these information collections.

14. Cost to Federal Government

There are no additional costs to the federal government.

15. Changes to Burden

Burden hours increased by 7,642 hours (from 31,484 hours to 39,126 hours). This change is mainly due to more issuers (376 in the previously approved package compared to 434 in this current request) participating in the health insurance Exchanges. In addition, because the burden is calculated separately for the 219 QHP issuers and 215 SADP issuers on the Exchanges, the increased burden reflects greater growth in QHP issuers (175 in the previously approved package compared to 219 in this current request, an increase of 25 percent) compared with SADP issuers (201 in the previously approved package compared to 215 in this current request, an increase of 7 percent). Because SADP issuers are not required to make updated formulary information available to consumers and to CMS, we estimate that SADP issuers will require no pharmacist burden hours and will require half the burden hours estimated for QHPs for the remaining labor categories (per respondent). As a result of including more total issuers in the calculations, and proportionally higher numbers of QHP issuers, specifically, whose organizations will bear a higher reporting burden, the total three-year cost has increased from $2,780,537.46 to $3,474,187.52.

16. Publication/Tabulation Dates

The updating of provider and formulary data by QHPs occurs monthly. The updating of provider data by SADPs also occurs monthly. The data collected will be submitted to CMS and made public through the QHP and SADP issuers’ websites on a recurring basis to ensure the most up-to-date information is available to Marketplace consumers.

17. Expiration Date

The expiration date and OMB control number will appear on the first page of the instrument (top-right corner).

1 Note that 45 C.F.R. 156.122(d)(2) includes individual and SHOP QHPs but does not include stand-alone dental plans (SADP). Therefore, SADP issuers are not required to provide drug formulary data in a machine-readable format.

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