Oferta de semillas

Under the Paperwork Reduction Act of 1995 (PRA), we are required to provide 30-day notice in the Federal

Register and solicit public comment

before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. To fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 requires that we solicit comment on the following issues:

• The need for the information collection and its usefulness in carrying out the proper functions of our agency.

• The accuracy of our estimate of the information collection burden.

• The quality, utility, and clarity of the information to be collected.

• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

The following sections of this document contain estimates of paperwork burden; however, not all of these estimates are subject to the information collection requirements (ICRs) under the PRA for the reasons noted.

A. Collections Related to State Operation of Reinsurance & Risk Adjustment Programs (§ 153.210 Through § 153.240, § 153.310)

In sections § 153.210 through

§ 153.240 and § 153.310 of the proposed rule, we estimated the cost of collecting data for State-operated reinsurance and risk adjustment. Fewer than 10 States have told HHS that they will operate reinsurance or risk adjustment for the

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34_{We use an estimate of self-insured entities}

published by the Department of Labor in the April 2012 ‘‘Report to Congress: Annual Report of Self- insured Group Health Plans,’’ which reflects only those self-insured health plans (including 14,800 self-insured plans and 6,300 plans that mixed self- insurance and insurance) that are required to file a Form 5500 with the Department of Labor. 2014 benefit year. Since collections

from fewer than 10 persons are exempt from the PRA under 44 U.S.C.

3502(3)(A)(i), we are not seeking PRA approval for these information collection requirements. However, if more than nine States elect to operate risk adjustment in the future, we will seek PRA approval for these information collections.

Comment: One commenter stated that our administrative cost estimates for these provisions were too low to be credible. Another commenter stated that we underestimated the cost to States of administering supplemental reinsurance payment parameters and monitoring fund balances. In particular, the commenter stated that establishing a governing board, engaging with stakeholders, and hiring independent actuaries would be expensive. One commenter believed that the cost to submit a report should include the State’s costs for executive-level review to determine whether to operate reinsurance, and that HHS was confusing regulatory cost with the PRA’s information collection burden.

Response: We limited our estimates in the proposed rule to the incremental information collection associated with the requirements of these provisions. In the ‘‘Supporting Statement for

Paperwork Reduction Act submissions: Standards related to Reinsurance, Risk Corridors, and Risk Adjustment’’ (Premium Stabilization Rule Supporting Statement), we estimated a baseline cost for the development of the State notice of benefit and payment. Therefore, we believe that there will only be a small incremental cost to States as a result of the reporting requirements at § 153.210 through § 153.240, § 153.310. However, for reasons described earlier in this Collection of Information section, we are not seeking PRA approval for these collections. We have moved our discussion of the administrative costs associated with these provisions to the Regulatory Impact Analysis section of this final rule.

B. ICRs Regarding Calculation of Reinsurance Contributions (§ 153.405)

In § 153.405, we finalize the rules related to an annual enrollment count of covered lives by contributing entities using counting methods derived from the PCORTF Rule. We are requiring contributing entities to provide annual counts of their enrollment and remit reinsurance contributions to HHS based on that enrollment count. The work associated with this requirement is the time and effort required by an issuer or self-insured group health plan to derive an annual enrollment count. Because

issuers or self-insured group health plans will already be obligated to determine a count of covered lives using a PCORTF counting method, the cost associated with this requirement is conducting these counts using the slightly modified counting methods specified in this final rule. In this final rule, we are modifying our estimate of the number of contributing entities from the proposed rule. We estimate that 22,900 contributing entities will be subject to this requirement, based on the Department of Labor’s estimated count of self-insured plans and the number of fully insured issuers that we estimate will make reinsurance contributions.34 On average, we estimate it will take each issuer or self-insured group health plan 1 hour (at a wage rate of $55 for an operations analyst) to calculate and submit final enrollment counts to HHS. Therefore, we estimate an aggregate cost of $1,259,500 for 22,900 reinsurance contributing entities as a result of this requirement. We will revise the Premium Stabilization Rule Supporting Statement to include the required data elements that issuers or self-insured group health plans will need to submit their annual enrollment counts in accordance with the counting methodology established in this final rule.

C. Requests for Reinsurance Payment (§ 153.410)

As described in § 153.410, issuers of reinsurance-eligible plans seeking reinsurance payments must make requests in accordance with the requirements of this final rule or the State notice of benefit and payment parameters, as applicable. To be eligible for reinsurance payments, issuers of reinsurance-eligible plans must submit or make accessible to HHS or the State, as applicable, all necessary data to be considered for reinsurance payments for the applicable benefit year.

To minimize burden on issuers, HHS intends to collect data in an identical manner for HHS-operated reinsurance programs and HHS-operated risk adjustment. Although we clarified the data elements issuers would be required to submit as part of the reinsurance payment request process, the burden associated with this requirement is already accounted for under the Premium Stabilization Rule Supporting

Statement with an October 31, 2015 expiration date, and we will update it to reflect these clarified data elements. D. Upload of Risk Adjustment and Reinsurance Data (§ 153.420, § 153.700, § 153.710, § 153.720)

Under the HHS-operated risk adjustment and reinsurance programs, HHS will use a distributed data collection approach for enrollee-level enrollment, claims and encounter data that reside on an issuer’s dedicated data environment. Under § 153.710(a), an issuer of a risk adjustment covered plan or a reinsurance-eligible plan in a State where HHS is operating the risk adjustment or reinsurance on behalf of the State, as applicable, must provide HHS, through the dedicated data environment, access to enrollee-level plan enrollment data, enrollee claims data, and enrollee encounter data, as specified by HHS. Under § 153.710(b), all claims data submitted by an issuer of a risk adjustment covered plan or a reinsurance-eligible plan in a State in which HHS is operating risk adjustment or reinsurance, as applicable, must have resulted in payment by the issuer. Under § 153.710(c), an issuer of a risk adjustment covered plan or a

reinsurance-eligible plan in a State in which HHS is operating risk adjustment or reinsurance, as applicable, that does not generate individual enrollee claims in the normal course of business must derive costs on all applicable provider encounters using its principal internal methodology for pricing those

encounters.

Issuers will be directed to make risk adjustment and reinsurance data accessible to HHS in a way that

conforms to HHS-established guidelines and applicable standards for electronic data collection and submission, storage, privacy and security, and processing. In § 153.720(a), we require these issuers to establish a unique masked enrollee identification number for each enrollee, in accordance with HHS-defined requirements and maintain the same masked enrollee identification number for enrollees that enroll in different plans within the issuer, within the State, during a benefit year. Issuers must provide all data to HHS in the specified formats, and must correct submitted files to resolve problems detected by HHS during file processing. The cost associated with this requirement is the time and effort to ensure that

information in the dedicated data environment complies with HHS requirements. We estimate this will affect 1,800 issuers and will cost each issuer approximately $178 per year, reflecting three hours of work by a

35_{‘‘Health Plans’ Estimated Costs of Compliance}

with Expanded Federal Rate Review and with Data Collection for Risk Adjustment and Reinsurance,’’ Center for Policy Research, America’s Health Insurance Plans, December 2012.

technical employee at $59.39 per hour. Therefore, we estimate an aggregate cost of $320,706 for all issuers as a result of these provisions.

In addition, we discussed in the proposed rule an updating amendment to the Premium Stabilization Rule Supporting Statement that was approved with an October 31, 2015 expiration date reflecting updated cost estimates for implementing the distributed data approach. We are making a slight modification to the labor estimate we assumed in our proposed rule by assuming Federal holidays and two weeks of vacation time for full time employees. In this final rule, we estimate that this data submission requirement will affect 1,800 issuers, and will cost each issuer approximately $342,086 in total labor costs. This cost reflects an estimate of three full-time equivalent employees (5,760 hours per year) at an average hourly rate of $59.39 per hour. We anticipate that

approximately 400 data processing servers will be established across the market in 2014 (at an average cost of $15,000), and these servers will process approximately 9 billion claims and enrollment files. Therefore, we estimate an aggregate cost that includes labor and capital of $621,754,800 for all issuers as a result of these provisions. Although we had previously accounted for this estimate as a new administrative cost to issuers in the proposed rule, we are not doing so in this final rule because it is not an incremental cost that issuers will incur as a result of the provisions in this final rule. We had previously estimated the costs associated with these risk adjustment and reinsurance enrollment data submission requirements in the Premium Stabilization Rule Supporting Statement that was approved with an October 31, 2015 expiration date. We will revise that supporting statement to reflect our updated estimate. We are also amending the tables in the Collection of Information section and Regulatory Impact Analysis section of this final rule so that the tables reflect only those incremental costs that result from provisions of this final rule.

Comment: One commenter stated that there was no basis for the proposed estimate and that the values seemed low considering the importance and

complexity of the tasks involved. The commenter also believed that the estimate did not account for costs associated with overhead,

administrative tasks, and employee benefits.

Response: We believe that our proposed estimate is reasonable for first year operations. The estimate reflects average labor and capital costs

associated with standing up a dedicated data environment, as well as average claims volume. Some issuers will have appropriate staff and infrastructure in place to support the data collection and other issuers will need to acquire resources. While we anticipate an initial concentrated effort for set-up of the dedicated data environment, we believe that three full-time equivalents would cover the number of hours needed (on average) for set-up and maintenance in the first year of operations. The average hourly rate of $59.39 is based on the Bureau of Labor Statistics, U.S. Department of Labor, National Compensation Survey: Occupational Earnings in the United States, 2011. We note that it approximates the lower range of hourly wages, $60, estimated by respondents to a recent industry

survey,35_{and that industry respondents’} cost estimates ranged widely to reflect different pricing and conditions. Our aggregate cost estimate also includes costs associated with capital purchases, overhead, and fringe benefits.

E. ICR Regarding User Fee When HHS Operates Risk Adjustment (§ 153.610) Under § 153.610(f), we establish a user fee to support Federal operation of risk adjustment. This per capita monthly fee will be charged to issuers of risk adjustment covered plans based on enrollment estimates provided to HHS in the distributed data

environment. HHS will calculate user fees owed, and issuers will remit the fee owed only once, in June of the year following the benefit year, in connection with processing of payments and charges for risk adjustment.

We estimate that 1,800 issuers will be required to pay risk adjustment user fees, and the additional cost associated with this requirement is the time and effort for an issuer to provide monthly enrollment data and remit fees. Because HHS will utilize existing data collection and payments and charges processing, we do not anticipate that this provision will alter the collection cost that is already approved in the Premium Stabilization Rule Supporting Statement under OMB control number 0938–1155 with an October 31, 2015 expiration date.

F. ICRs Regarding Data Validation Requirements When HHS Operates Risk Adjustment (§ 153.630)

Under § 153.630(b), an issuer that offers at least one risk adjustment

covered plan in a State where HHS is operating risk adjustment on behalf of the State for the applicable benefit year must have an initial validation audit performed on its risk adjustment data. The cost associated with this

requirement is the issuer’s time and effort to provide HHS with source claims, records, and enrollment information to validate enrollee

demographic information for initial and second validation audits and the issuer’s cost to employ an independent auditor to perform the initial validation audit on a statistically valid sample of enrollees.

The statistically valid sample of enrollees provided to each issuer will consist of enrollees both with and without HCCs. We estimate that each issuer sample will consist of

approximately 300 enrollees, with approximately two-thirds of the sample consisting of enrollees with HCCs. We anticipate that this audit will affect approximately 1,800 issuers.

Based on Truven Health Analytics 2010 MarketScan®_{data, we have}

determined that for enrollees with HCCs, the average number of HCCs to be reviewed by an auditor per enrollee is approximately two. Additionally, based on HHS audit experience, we estimate that it will cost approximately $180 ($90 per hour for two hours) for an auditor to review the medical record

documentation for one enrollee with two HCCs. In the proposed rule, we did not estimate the cost of reviewing medical records for enrollees without HCCs. HHS intends to require the review of medical records for all sample enrollees in the initial validation audit. Therefore, we are revising our estimate to align with the policy finalized in this rule. We expect that it may cost

approximately $60 per enrollee ($90 per hour for 40 minutes) to validate

demographic information and review medical records for all enrollees in the audit sample, totaling approximately $210 per enrollee with HCCs ($90 per hour for two hours and 20 minutes) and $60 per enrollee with no HCCs. We assume that an initial validation audit will be performed on 180,000 enrollees without HCCs, and 360,000 enrollees with HCCs. Based on the information above, we estimate that the total cost per issuer to retain initial validation

auditors to perform the initial validation would cost approximately $48,000. Therefore, for 1,800 issuers, the total cost of conducting initial validation audits will be $86.4 million. We will revise the information collection currently approved OMB Control Number 0938–1155 with an October 31,

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2015 expiration date to account for this additional burden.

Under § 153.630(d), issuers will have the opportunity to appeal errors

identified through the second validation audit process. Because we intend to provide further detail on this process in later guidance and rulemaking, we currently cannot estimate the number of issuers that will appeal HCC findings, or the cost per issuer for doing so.

Therefore, we will seek OMB approval and solicit public comment on the information collection requirements established under § 153.630(d) at a future date.

G. ICRs Regarding QHP Certification Standards Related to Advance Payments of the Premium Tax Credit and Cost-Sharing Reductions (§ 155.1030)

In § 155.1030(a)(1) of this final rule, we establish that the Exchange must ensure that each issuer that offers or intends to offer a QHP in the individual market on the Exchange submit the required plan variations, as set forth in § 156.420, for each of its health plans proposed to be offered as a QHP in the individual market on the Exchange. Further, the Exchange must certify that the plan variations meet the

requirements detailed in § 156.420. We expect that an Exchange will collect prior to each benefit year the

information necessary to validate that the issuer meets the requirements for silver plan variations, as detailed in § 156.420(a), and collect as part of QHP certification the information necessary to validate that the issuer meets the requirements for zero and limited cost sharing plan variations, as detailed in § 156.420(b). We expect that this data collection would include the cost- sharing requirements for the plan variations, such as the annual limitation on cost sharing, and any reductions in deductibles, copayments or

coinsurance. In addition, the Exchange will collect or calculate the actuarial values of each QHP and silver plan variation, calculated under § 156.135 of the final EHB/AV Rule. We proposed in § 155.1030(a)(2) that the Exchange provide the actuarial values of the QHPs and silver plan variations to HHS. As set forth in § 155.1030(b)(4), HHS may use this information in connection with approving estimates for advance payment of cost-sharing reductions submitted by issuers under § 156.430 finalized here. Because HHS will already have this information for Federally-facilitated Exchanges, the burden associated with this requirement is the time and effort for a State

participating in each State Partnership

and for a State-based Exchange to submit this information to HHS. We estimate that the submission from each of these entities will take approximately 3.5 hours to collect, validate, and submit to HHS (3 hours by a database administrator at $47.70 per hour, and 0.5 hours by a manager at $75.15 per hour). We estimate that this will cost each submitting entity approximately $181 per year. We plan to revise the supporting statement published under CMS form number 10433, which is pending OMB approval, to account for this additional burden.

In paragraph (b)(1) and (2), we established that the Exchange collect, review, and submit the rate or expected premium allocation, the expected allowed claims cost allocation, and the actuarial memorandum that a metal level health plan or stand-alone dental plan issuer submits under § 156.470. This collection will allow for the calculation of the advance payments of