Supporting Statement Part A
Medicare Prescription Drug Benefit Program
CMS-10141, OMB 0938-0964
This is a revision of an approved collection. We are adding a new burden to reflect business continuity requirements under §§ 422.504(o) and 423.505(p). We are also modifying the burden previously reported and approved to reflect more recent CMS experience as well a decrease in the number of Part D sponsors and increased labor costs, to correct errors in previously reported data, and to delete the burden related to requirements that are no longer subject to the PRA.
Background
The Centers for Medicare and Medicaid Services (CMS) published the final rule to establish the Medicare Prescription Drug Benefit on January 28, 2005. The PRA requirements referenced in this PRA submission, as reflected in the final regulation, assisted in the implementation of the provisions of the Social Security Act (the Act) establishing and regulating the Medicare Prescription Drug Benefit and continue to support administration of the program. The voluntary prescription drug benefit program was enacted into law on December 8, 2003 in section 101 of Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). As specified in the MMA, the prescription drug benefit program became available to beneficiaries beginning on January 1, 2006.
The submission consists of four information collection requests. The first is associated with new regulatory requirements related to business continuity plans that were finalized in the Federal Register on February 12, 2015 (80 FR 7912) and that apply, with some variations reflecting program needs, to Part D sponsors and Medicare Advantage (MA) organizations.
The remaining three collections are related to information requirements imposed on: Medicare beneficiaries; the private prescription drug plans and MA prescription drug plans that offer the Medicare Part D prescription drug benefit; and States. Information collected from beneficiaries supports Part D sponsor’s administration of eligibility, enrollment and benefit activities, including provision of beneficiary protections. The second collection, Part D sponsor information collection and reporting, is critical to CMS’ payment processes and enables us to evaluate sponsor compliance with the regulatory requirements governing plan administration of the Part D benefit. States determine beneficiary eligibility for the low-income subsidy available under Part D. This information, together with Medicaid eligibility information, is reported to CMS to support administration of the low-income subsidy program and identification of dual eligible beneficiaries. These latter three information collections have been updated as experience with the program has enabled CMS to refine our burden estimates. The approval for this collections expires on February 28, 2017, but because CMS has added new burdens, we are seeking renewal of existing collections as well.
A. Justification
1. Need and Legal Basis
Section 101 of Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added sections 1860D-1 through D-42 and sections Sec. 102, Sec. 103, Sec. 104 and Sec. 109 to the Social Security Act (the Act) establishing the Medicare prescription drug benefit program.
The previously approved information collection requirements are mandated by regulations at 42 CFR Part 423—Voluntary Medicare Prescription Drug Benefit. The regulations governing—
Medicare supplemental policies (Medigap) are in 42 CFR part 403 (subpart B);
exclusions from Medicare and limitations on Medicare payment (the physician self-referral rules) are in 42 CFR part 411;
managed care organizations that contract with CMS under cost contracts are in 42 CFR part 417, Health Maintenance Organizations, Competitive Medical Plans, and Health Care Prepayment Plans; and
PACE organizations are in 42 CFR part 460.
The new information requirements are mandated by regulations at 42 CFR §§422.504(o) and 423.505(p) which were finalized on February 12, 2015. These provisions respectively require MA organizations and Part D sponsors to develop business continuity plans with the goal of better ensuring beneficiary access to health care services and Part D drugs during and after interruptions to regular business operations. (80 FR 7912). However, when we originally proposed these regulations on January 10, 2014, we did not include these proposed regulations in the Collection of Information Requirements section, which meant there was no 60 day notice to solicit public comment. (79 FR 1918). To correct this oversight we published separate Federal Register notices (April 10, 2015, 80 FR 19323 and June 19, 2015, 80 FR 35362) which solicited public comment for 60- and 30-days, respectively. No comments were received in response to these solicitations.
2. Information Users
Part D plans and, to the extent applicable, MA organizations will use the information discussed below to comply with the eligibility and other requirements associated with their participation in Part D. CMS will use this information from plan sponsors and States to approve contract applications, monitor compliance with contract requirements, make proper payment to plans, and ensure that correct information is disclosed to potential and current enrollees. The new information collection will allow CMS to ensure sponsors have plans in place to restore business operations following a disruption of regular operations. Medicare beneficiaries will use the information provided by the Part D sponsors to make decisions regarding Part D enrollment as well as grievance and appeal requests.
3. Improved Information Technology
Where feasible the collection of information covered by this regulation will involve the use of automated, electronic, mechanical, or other technological collection techniques designed to reduce burden and enhance accuracy.
4. Duplication of Similar Information
The information collection requirements contained in the regulations are not duplicated through any other effort.
5. Small Businesses
Some Part D sponsors and MA organizations are small businesses so they may be affected. They will have to comply with all the information requirements described in this supporting statement.
6. Less Frequent Collection
This information is collected on the least frequent basis necessary to support CMS’ administration of the Part D and MA programs and plan sponsor’s provision of benefits under their contracts with CMS. With less frequent collection, CMS would not have access to the data necessary to administer these programs and plan sponsors.
For example, under the new information collection on business continuity plans, existing plan sponsors are required to annually test their plan and update these documents as needed. New plan sponsors without existing business continuity plans must develop and implement such plans. Business continuity plans ensure that plan sponsors are able to restore business operations after disruptions caused by events such as natural or man-made disasters, systems failures and emergencies. In another example information collected from beneficiaries is collected when an enrollment application is filed and when a coverage determination is requested. Other information, such as other payers reimbursing Part D costs on the enrollee’s behalf, is collected from beneficiaries only annually. Information from Part D sponsors related, for example, to drug utilization management or dissemination of plan information, is an annually requirement; however, although bid information from sponsors is an annual collection, cost information is collected monthly. Information collected from the states pertaining to low-income subsidy determinations and redeterminations is collected monthly.
Conducting testing of business continuity plans less frequently than annually increases the risks associated with a service disruption to beneficiary access to care and coverage. Some other consequences of less frequent collection would be improper or erroneous payment to Part D plans, improper enrollment of beneficiaries in a Part D organization, release of misleading information regarding the health care coverage through a plan to potential members, and inadequate provision of patients’ rights to Medicare-covered services.
7. Special Circumstances
Generally, information collections contained in the Part D drug program occur annually or quarterly. Special circumstances may require information to be submitted to the agency more often than quarterly. (See section 12 below for specific instances.)
8. Federal Register Notice/Outside Consultation
The 60-day Federal Register notice published on April 10, 2015 (80 FR 19323). No comments were received.
9. Payments/Gifts To Respondents
There are no payments/gifts to respondents.
10. Confidentiality
CMS recognizes the potential confidential or proprietary nature of the information related to the new information collection on business continuity plans. Plans are not required as a matter of course to submit these plans to CMS or to make such plans publicly available. If CMS requests the documents, we do not intend to voluntarily disclose then to any parties outside the government. Although the documents may be subject to release under the Freedom of Information Act (FOIA) plan sponsors may seek to protect their information from disclosure by claiming FOIA exemption 4 and taking the appropriate steps, including labeling the information in questions as “confidential” or “proprietary.”
The information collected from organizations for the purposes of disclosing to the potential enrollees their health care coverage choices is public information. The information is being collected for purposes of the National Medicare Education Program, the purpose of which is the broad public dissemination of objective, comparative information on benefits, program rules, and premiums of the contracting with organizations. The information collected from Medicare beneficiaries and contained in medical records and other health and enrollment information must conform to all requirements at 42 CFR Parts 417, 422, and 423 including all Federal and State laws regarding confidentiality and disclosure.
11. Sensitive Questions
There are no sensitive questions included in this collection effort.
12. Burden Estimate (Total Hours & Wages)
The information collections set out under this burden section consist of six Information Collection Requests (ICRs):
12.1 ICRs Regarding Business Continuity Plans under §§422.504(o) and 423.505(p)
12.2 ICRs Regarding Medicare Prescription Drug Benefit Program (Beneficiaries)
12.3 ICRs Regarding Medicare Prescription Drug Benefit Program (Plans)
12.4 ICRs Regarding State Eligibility Determinations [423.904(b)] and Reporting [423.910(d)]
12.5 ICRs Exempt from the Requirements of the Paperwork Reduction Act
12.6 Related ICRs Approved Under Other OMB Control Numbers
To derive average costs, we used data from the U.S. Bureau of Labor Statistics’ May 2014 National Occupational Employment and Wage Estimates for all salary estimates (www.bls.gov/oes/current/oes_nat.htm). In this regard, we believe that a Business Operations Specialists (Occupation Code 13-1199) will perform the PRA-related tasks at a mean hourly wage of $35.10/hr.
12.1 ICRs Regarding Business Continuity Plans under §§422.504(o) and 423.505(p)
This section describes a new ICR.
12.1.1 Contract provisions (§§422.504 and 423.505)
Sections 422.504(o) and 423.505(p) require, respectively, MA organizations and Part D sponsors to develop, maintain, and implement business continuity plans that identify potential business disruptions and develop ways to maintain functions or restore them as soon possible thereafter. We believe many entities already have developed and are maintaining plans that meet these requirements for two reasons - 1) creating business continuity plans is a well-established practice across most industries; and 2) CMS finalized a regulation (80 FR 7912) that created flexibility for industry practices related to business continuity. Accordingly, the burden associated with the requirement is the time and effort necessary for Part D sponsors and MA organizations without plans to develop and maintain business continuity plans and the time and effort for entities that have existing business continuity plans that do not meet all the requirements to revise them. For the first year, we estimate 28 entities do not have the plans in place and it will take 240 hours each to fulfill the business continuity requirements, for a total burden of 6,720 hours. We also estimate that there are 57 entities with existing plans that need to be updated and it will take 120 hours to revise their business continuity plans in the first year, for a total burden of 6,840 hours.
In subsequent years, we estimate there will be 9 new Part D sponsors and MA organizations that do not already have a business continuity plan based on our experience that most entities that create new plans each year are under parent organizations that already have business continuity plans in place. We estimate a burden of 240 hours for each of these 9 entities. We also estimate that 5 entities with existing plans will either experience a problem or for some other reason update their plan and it will take each plan 40 hours for these revisions. For each subsequent year, we estimate 9 entities will not have the plans in place and it will take 240 hours each to fulfill the business continuity requirements, for a total burden of 2,160 hours. We also estimate for each subsequent year 5 entities with existing plans will need to update their business continuity plans and it will take 40 hours for each plan to make these revisions, for a total burden of 200 hours.
Burden Summary (Subtotal)
CFR Section |
Respondent Type |
# Respondents |
Time (hr per response) |
# Responses (per respondent) |
Total Responses (all respondents) |
Total Annual Time (all respondents) |
423.505(p) combined with 422.504(o) |
Private sector (Contracts) |
28 |
240 |
1 |
28 |
6,720 |
57 |
120 |
1 |
57 |
6,840 |
||
9 |
240 |
1 |
9 |
2,160 |
||
5 |
40 |
1 |
5 |
200 |
||
Subtotal |
99 |
-- |
1 |
99 |
15,920 |
|
12.2 ICRs Regarding Medicare Prescription Drug Benefit Program (Benes)
The changes in two of the ICRs described below reflect recent CMS experience. The specific ICRs are those related to the provisions related to enrollment process and creditable coverage.
12.2.1 Enrollment process (§423.32)
(a) A Part D eligible who wishes to enroll in a Part D plan may enroll during the enrollment periods specified in §423.38, by submitting an enrollment request to the Part D plan through one of the mechanisms CMS determines are appropriate.
The burden associated with this requirement is the time and effort necessary for an individual to submit the enrollment request to a Part D plan sponsor. We estimate that it will take 30 minutes (0.5 hours) to complete and submit the request to the Part D plan. Since the inception of the Part D program in 2006, more than 30 million individuals are enrolled in the program. Once enrolled, individuals are not required to complete an enrollment request to remain enrolled in their chosen plan year-to-year. Generally individuals are limited to changing Part D plans during the annual coordinated election period, and enrollment data indicates that individuals typically stay with a plan once enrolled. In the Fall of 2014, about 1.9 million individuals newly enrolled in or switched stand-alone Medicare prescription drug plans (PDPs) during the annual coordinated election period; these enrollments took effect on January 1 of 2015. New PDP enrollments (not counting those with a January 1effective date) average approximately 186.000 per month. Therefore, it is estimated that a total of 3.954 million individuals may newly enroll in or change their PDP annually. The total burden is calculated to be 3.954 million enrollments x 0.5 hours = 1,975,000 hours. The change in burden is due to decreases in the number of individuals enrolling in Part D plans.
(b) Enrollment form or CMS-approved mechanism. The enrollment request must be completed by the individual and include an acknowledgement by the beneficiary for disclosure and exchange of necessary information between the U.S. Department of Health and Human Services (or its designees) and the Part D plans sponsor. Persons who assist beneficiaries in completing the enrollment, including authorized representatives, must indicate they have provided assistance and their relationship to the beneficiary. The burden associated with this requirement is reflected above under section 423.32(a).
A Part D plan sponsor must require Part D eligible individuals enrolling or enrolled in its Part D plan to provide information regarding reimbursement for Part D costs through other insurance, group health plan or other third-party payment arrangement, in a form and manner approved by CMS. All new enrollments require this information as part of the enrollment application (burden reflected under section 423.32(a)); however, plan sponsors may request currently enrolled members to provide this information upon indication of other insurance.
The burden associated with the requirement for individuals enrolled or enrolling in a Part D plan to provide information regarding reimbursement for Part D costs through other insurance, group health plan or other third-party payment arrangement is a total annual burden of 44,200 hours. We estimate that 2.6 million beneficiaries will need 1 minute (0.017 hours) to disclose reimbursement for Part D costs to the appropriate entity on an annual basis, for a total annual burden of 44,200 hours.
12.2.2 Enrollment of full-benefit dual eligible individuals (§423.34)
Section 423.34(e) states that a full-benefit dual eligible beneficiary may decline automatic enrollment in a Part D plan or may enroll in a plan different than the plan into which CMS placed them.
The burden associated with this requirement is the time and effort put forth by the individual to actively decline enrollment or to actively enroll in a new, and for plans to process the enrollments and disenrollments. We estimate it would take an individual about 15 minutes (0.25 hours) to, either contact the plan to disenroll or contact the new plan to enroll (resulting in an automatic disenrollment from the plan into which the person was enrolled by CMS). Beneficiaries can contact plans in a number of ways, with varying amounts of time needed for the contact. A beneficiary would need to contact the plan only once. There are, on average, approximately 130,000 individuals who choose their own plan instead of the automatic enrollment each year so we estimate that it takes full dual beneficiaries 32,500 hours each year to decline the automatic enrollment or enroll in a different plan (causing a disenrollment). We further estimate the same amount of time for plans to receive and process these enrollments/disenrollments. The total number of hours is 32,500 hours for the full dual beneficiaries.
12.2.3 Enrollment periods (§423.38)
In paragraph (b), under the Special Enrollment Period provisions, an individual is eligible to enroll in a Part D plan or disenroll from a Part D plan and enroll in another Part D plan, if the individual demonstrates to CMS, in accordance with guidelines CMS issues, that the Part D plan sponsor offering the Part D plan substantially violated a material provision of its contract under this part that meets the requirements set forth in this section.
The burden associated with this requirement is the time and effort necessary for an individual to submit the required materials to CMS demonstrating that a Part D plan substantially violated a material provision of its contract. Based on our experience with the current Medicare Advantage program, we would expect that fewer than 10 individuals, if any, will avail themselves of this option. Generally, in those instances where CMS has found that an MA organization has substantially violated a material provision of its contract, CMS has taken the necessary action on behalf of these individuals. Thus, we do not estimate any burden on individuals under this provision.
12.2.4 Procedures to document creditable status of prescription drug coverage (§ 423.56)
If an individual establishes to CMS that he or she was not adequately informed that he or she no longer had creditable prescription drug coverage or the coverage is involuntarily reduced, the individual may apply to CMS to have the coverage treated as creditable coverage so as to not be subject to the late enrollment penalty described in §423.46. The burden associated with this requirement is the time and effort necessary for an individual to apply to CMS to have such coverage treated as creditable coverage. Based on recent experience (i.e., 2012 – 2014, we estimate that on an annual basis it will take 100 individuals 15 minutes (0.25 hours) to apply to CMS, for a total of 25 hours.
12.2.5 Exceptions process (§423.578)
In paragraphs (a) and (b) an enrollee, the enrollee’s representative, or the enrollee’s prescribing physician or other prescriber (on behalf of the enrollee) may file a request for an exception that meets the requirements of this section.
The burden associated with this requirement is the time and effort necessary for an individual to submit an exception request. We estimate that that 3,185,000 exception requests will be received by 424 Part D plan sponsors. We further estimate it will take an individual an average of 15 minutes (0.25 hours) to provide the request for a total annual burden of 796,250 hours.
Burden Summary (Subtotal)
CFR Section |
Respondent Type |
# Respondents |
Time (hr per response) |
# Responses (per respondent) |
Total Responses (all respondents) |
Total Annual Time (all respondents) |
423.32(a) and (b) |
Individual |
3,954,000 |
0.5 |
1 |
3,954,000 |
1,975,000 |
423.32(b) |
Individual |
2,600,000 |
0.017 (1 min) |
1 |
2,600,000 |
44,200 |
423.34(e) |
Individual |
130,000 |
0.25 |
1 |
130,000 |
32,500 |
423.56(f) |
Individual |
100 |
0.25 |
1 |
100 |
25 |
423.578(a) and (b) |
Individual |
3,185,000 |
0.25 |
1 |
3,185,000 |
796,250 |
Subtotal |
9,869,100 |
-- |
1 |
9,869,000 |
2,847,975 |
|
12.3 ICRs Regarding Medicare Prescription Drug Benefit Program (Plans)
The changes in the ICRs described below reflect:
Recent CMS experience related to enrollment and disenrollment notice requirements, involuntary disenrollments by plans, and creditable coverage;
Increased labor costs; and
A decreased number of Part D plan sponsors.
12.3.1 Enrollment process (§423.32)
(d) Notice requirement. The Part D plan sponsor must provide the individual with prompt notice of acceptance or denial of the individual’s enrollment request, in a format and manner specified by CMS.
The burden associated with this requirement is the time and effort necessary for a Part D plan sponsor to provide an individual notice of acceptance or denial of the individual’s enrollment request. Every enrollment request requires a response from the Part D plan so that the individual knows if he or she will be covered under the plan. There are approximately 793 Part D plan sponsors in 2015. Each Part D plan creates the acceptance and denial notices, and most plans continue to use the same notice year-after-year, with some minor adjustments. Therefore, we estimate that it will take each Part D plan approximately 3 hours to produce each notice –an acceptance and a denial notice. 793 plan sponsors x (3 hours x 2 notices) = 4,758 hours. We further estimate that on average, it will take each Part D plan sponsor 1 minute (0.017 hours) to assemble and disseminate the proper notice for each of the enrollment requests received annually. 3.954 million requests x 0.017 hours (1 minute each) = 67,218 hours. The total number of hours is 71,976 (4,758 + 67,218) or 92.43 hours per sponsor annually. The estimated annual cost is $2,526,358 ($35.10/hr x 71,976 hr).
12.3.2 Enrollment of full-benefit dual eligible individuals (§423.34)
As noted above, section 423.34(e) states that a full-benefit dual eligible beneficiary may decline automatic enrollment in a Part D plan or may enroll in a plan different than the plan into which CMS placed them.
The burden associated with this requirement is the time and effort put forth by the individual to actively decline automatic enrollment or to actively enroll in a new, and for plans to process the enrollments and disenrollments. We estimate it would take an individual about 15 minutes (0.25 hours) to, either contact the plan to decline the automatic enrollment or contact a different plan to enroll (resulting in an automatic disenrollment from the plan into which the person was enrolled by CMS). Beneficiaries can contact plans in a number of ways, with varying amounts of time needed for the contact. A beneficiary would need to contact the plan only once. There are on average approximately 130,000 individuals who choose their own plan instead of the automatic enrollment each year so we estimate that it takes full dual beneficiaries 32,500 hours a year to decline the automatic enrollment or enroll in a different plan (causing a disenrollment) each year. We further estimate the same amount of time for plans to receive and process these declinations/enrollments. The total burden is 32,500 hours for the 793 Part D plan sponsors. The estimated annual cost is $1,140,750 ($35.10/hr x 32,500 hr).
12.3.3 Disenrollment process (§423.36)
Section (b) requires the Part D plan sponsor to submit a disenrollment transaction to CMS within timeframes CMS specifies; provide the enrollee with a notice of disenrollment as CMS determines and approves; and file and retain disenrollment requests for the period specified in CMS instructions.
The burden associated with this requirement is the time and effort necessary for a Part D plan sponsor to provide an individual a notice of disenrollment, whether it is the result of the individual leaving the Part D program or switching plans during a valid enrollment period. Based on disenrollment data for January through August 2015, we estimate that on an annual basis it will require a total of 1,903,752 notices, affecting each Part D plan sponsors to some degree, as described below. There are approximately 793 Part D plan sponsors in 2015. Each Part D plan creates the disenrollment notice, and most plans continue to use the same notice year-after-year, with some minor adjustments. Therefore, we estimate that it will take each Part D plan sponsor approximately 1 hour to produce the notice. 793 plan sponsors x 1 hour = 793 hours. We further estimate that on average, it will take each Part D plan sponsor 1 minute (0.017 hours) to assemble and disseminate the notice for each disenrollment. 1,903,752 notices x 0.017 hours (1 minute each) = 32,364 hours. The total number of hours is 33,157 hours (793 + 32,364) or 41.8 hours per sponsor annually. The estimated annual cost is $1,163,811 ($35.10/hr x 33,157 hr).
12.3.4 Involuntary disenrollment by the Part D plan (§423.44)
If the disenrollment is for any of the reasons specified in paragraphs (b)(1), (b)(2)(i) or (b)(2)(iv) of 42 CFR§423.44, the Part D plan sponsor must give the individual timely notice of the disenrollment with an explanation of why the Part D plan is seeking to disenroll the individual. Notices for these reasons must be provided to the individual before submission of the disenrollment notice to CMS; and include an explanation of the individual's right to a hearing under the Part D plan’s grievance procedures.
A Part D plan sponsor may disenroll an individual from the Part D plan for failure to pay plan premiums following a minimum 2-month grace period and if the Part D plan sponsor can demonstrate to CMS that it made reasonable efforts to collect the unpaid premium amount.
The burden associated with this requirement is the time and effort necessary for a Part D plan sponsor to effectuate the disenrollment and provide an individual the notice of disenrollment. There are approximately 793 Part D plan sponsors in 2015. Each Part D plan creates the disenrollment notice, and most plans continue to use the same notice year-after-year, with some minor adjustments. Therefore, we estimate that it will take each Part D plan approximately 1 hour to produce the notice. 793 plan sponsors x 1 hour = 793 hours. We estimate that it will take a Part D plan 5 minutes (0.083 hours) to submit the required transaction to CMS for each occurrence and 1 minute (0.017 hours) to assemble and disseminate the notice for each disenrollment. Based on disenrollment data for January through June 2015, we estimate that on an annual basis 496,344 individuals will be disenrolled for failure to pay premiums. 496,344 notices x 0.1 hours (6 minutes each) = 49,634 hours. The total number of hours is 50,427 (793 + 49,634) or 63.6 hours per sponsor annually. The estimated annual cost is $1,769, 988 ($35.10/hr x 50,427 hr).
Following the enactment of section 3308 of the Affordable Care Act in 2011 which required additional premium amounts to be paid directly to the government by higher-income individuals when enrolled in Part D, CMS may disenroll individuals who do not pay their additional premium amounts, also known as Part D Income Related Monthly Adjustment Amount (Part D-IRMAA), to the government within a 3-month grace period. If payment is not received timely, CMS processes the disenrollment and notifies Part D plans of the involuntary disenrollment, and the plan is required to notify their member of the disenrollment from their plan.
The burden associated with this requirement is the time and effort for the Part D plan sponsor to disclose to an individual the notice of disenrollment. There are approximately 793 Part D plan sponsors in 2015. Each Part D plan creates the disenrollment notices, and most plans continue to use the same notice year-after-year, with some minor adjustments. Therefore, we estimate that it will take each Part D plan approximately 1 hour to produce the notice. 793 plan sponsors x 1 hour = 793 hours. We estimate that it will take a Part D plan 1 minute (0.017 hours) to assemble and disseminate the notice for each disenrollment. Based on data from January 1 through September 23, 2015, we estimate that on an annual basis 1,100 individuals will be disenrolled for failure to pay Part D-IRMAA. 1,100 notices x 0.017 hours = 18.7 hours. The total number of hours is 811.7 (73 + 18.7) or 1.02 hours per sponsor annually. The estimated annual cost is $28,491 ($35.10/hr x 811.7 hr).
An individual who is disenrolled for non-payment of plan premiums or non-payment Part D-IRMAA may be reinstated by the Part D sponsor or by CMS, respectively, if the individual shows good cause for not paying premiums timely. In this process, the plan or CMS determines if good cause is met based on the individual’s request for review and his or her attestation of the unexpected and unforeseen event. Should an individual receive a favorable determination, the payment of all overdue premiums must be paid to the plan and CMS as applicable. Individuals are notified by the plan sponsor of the plan premium amount owed for reinstatement. CMS notifies individuals of any Part D-IRMAA amounts owed to the government.
The Part D plan sponsor burden associated with this requirement is the time and effort for the Part D plan sponsor to provide an individual the notice of the owed plan premium amount required for reinstatement. There are approximately 793 Part D plan sponsors in 2015. Each Part D plan creates the notice of the plan premium amount owed, and most plans continue to use the same notice year-after-year, with some minor adjustments. Therefore, we estimate that it will take each Part D plan approximately 1 hour to produce the notice. 793 plan sponsors x 1 hour = 793 hours. We estimate that it will take a Part D plan 5 minutes (0.083 hours) to compile the arrearage information and 1 minute (0.017 hours) to assemble and disseminate the notice for each favorable determination. We estimate that on an annual basis 17,772 individuals will request and receive favorable good cause determinations. 17,772 notices x 0.1 hours (6 minutes) = 1,777 hours. The total number of hours is 2,570 (793 + 1,777) or 3.24 hours per sponsor annually. The estimated annual cost is $90,207 ($35.10/hr x 2,570 hr).
A Part D plan may disenroll an individual whose behavior is disruptive, only after it meets the requirements described in guidance and after CMS has reviewed and approved the request. To disenroll an individual from its Part D plan, based on an individual’s behavior, the Part D plan sponsor must document the enrollee’s behavior, its own efforts to resolve any problems and any extenuating circumstances. The Part D plan must submit this information and any documentation received by the beneficiary to CMS. The Part D plan sponsor may request from CMS the ability to decline future enrollment by the individual.
The burden associated with this requirement is the time and effort necessary for a Part D plan to document and retain the documentation that meets the requirements set forth in guidance. We estimate that it will take a Part D plan 3 hours to capture and retain the required documentation for each occurrence. Based on actual experience, CMS receives approximately 1-2 total requests for involuntary disenrollment due to disruptive behavior annually. Thus, the burden to Part D plan sponsors is negligible.
In addition, the Part D plan must inform the individual of the right to use the Part D plan’s grievance procedures. The burden associated with this requirement is captured under section § 423.128.
When a Part D plan contract terminates as stipulated under 423.507 and 423.510 the Part D plan sponsor must send a notice to the enrollee before the effective date of the plan termination. The notice must give provide an effective date of the plan termination and a description of alternatives for obtaining benefits under Part D. The burden associated with these requirements is discussed below under sections 423.507 and 423.510.
12.3.5 Late enrollment penalty (§423.46)
Section 423.46(b) states that Part D sponsors must obtain information on prior creditable coverage from all enrolled or enrolling beneficiaries and report this information to CMS in a form and manner determined by CMS. Individuals enrolling in Part D with 63 days or more without creditable coverage will be assessed a Part D late enrollment penalty.
The burden associated with this requirement is the time and effort put forth by the Part D sponsor to obtain the required information. There are approximately 793 Part D plan sponsors in 2015. To comply with this requirement, Part D sponsors would expend 15 minutes (0.25 hours) per new Part D enrollee to obtain the information and report it to CMS for calculation of the late enrollment penalty, if one is required. We estimate that a total of 3.954 million individuals may newly enroll in or change their Part D plans annually and, as such, approximately 3,954 million new Part D enrollees will need to provide this information on an annual basis. Therefore the total annual burden associated with this requirement will be 3.954 million new enrollees x 0.25 hours (15 minutes) = 988,500 hours. The estimated annual cost is $34,696,350 ($35.10/hr x 988,500 hr).
Section 423.46(d) requires the Part D plan sponsor to retain all information collected concerning a credible coverage period determination in accordance with the enrollment records retention requirements described in subpart K, §423.505(e)(1)(iii).
The burden associated with this requirement is the time and effort put forth by the Part D plan sponsor to retain the required information. To comply with this requirement, Part D sponsors would expend 5 minutes (0.083 hours) per new Part D enrollee. We estimate that a total of 3.954 million individuals may newly enroll in or change their Part D plan annually. We estimate the total annual burden associated with this requirement will be 328,182 hours for all new Part D enrollees. The estimated annual cost is $11,519,188 ($35.10/hr x 328,182 hr).
12.3.6 Information about Part D (§423.48)
Each Part D plan must provide, on an annual basis, and in a format and using standard terminology that CMS may specify in guidance, the information necessary to enable CMS to provide to current and potential Part D eligible individuals the information they need to make informed decisions among the available choices for Part D coverage.
The burden associated with this requirement is the time and effort necessary for a Part D sponsor to submit the required materials to CMS. We estimate that on an annual basis it will take 793 Part D sponsors 2 hours to submit the required documentation to CMS for a total annual burden of 1,586 hours. The decrease in total annual burden from the previous estimate is due to the decreased number of respondents. The estimated annual cost is $55,669 ($35.10/hr x 1,586 hr).
12.3.7 Requirements related to qualified prescription drug coverage (§423.104)
(g) A Part D plan sponsor is required to disclose to CMS data on aggregate negotiated price concessions obtained from pharmaceutical manufacturers, as well as data on aggregate negotiated price concessions obtained from pharmaceutical manufacturers that are passed through to beneficiaries, via pharmacies and other dispensers, in the form of lower subsidies, prices, and/or monthly beneficiary prescription drug premiums, in the manner and frequency specified by CMS.
The burden associated with this requirement is the time and effort necessary for a Part D plan sponsor to disclose to CMS the aggregate negotiated price data on concessions. Given the complexity of this reporting, we estimate the time and effort required will be similar to that associated with the payment-related reporting requirements. Therefore, we estimate that on an annual basis it will take each of the 793 respondents 10 hours to submit the required documentation to CMS for total annual burden of 7,930 hours. The estimated annual cost is $278,343 ($35.10/hr x 7,930 hr).
12.3.8 Access to covered Part D drugs (§423.120)
(b) A Part D plan sponsor’s formulary must be reviewed by a pharmacy and therapeutic committee that must maintain written documentation of its decisions regarding formulary development and revision.
The burden associated with this requirement is the time and effort necessary for a Part D sponsor’s pharmacy and therapeutic committee to document and retain the documentation that meets the requirements set forth in this section. We estimate that it will take 793 respondents 2 hours each to capture and retain the required documentation on an annual basis for total annual burden of 1,586 hours. The decrease in total annual burden from the previous estimate is due to the decreased number of respondents. The estimated annual cost is $55,669 ($35.10/hr x 1,586 hr).
Prior to removing a covered Part D drug from its plan’s formulary, or making any change in the preferred or tiered cost-sharing status of a covered Part D drug, a Part D plan sponsor must provide at least 60 days notice to CMS, State Pharmaceutical Assistance Programs, entities providing other prescription drug coverage (as described in §423.464(f)(1)), authorized prescribers, network pharmacies, and pharmacists.
The burden associated with this requirement is the time and effort necessary for a Part D sponsor to provide notice of at least 60 days to CMS, State Pharmaceutical Assistance Programs, entities providing other prescription drug coverage, authorized prescribers, network pharmacies, and pharmacists of the removal of a covered Part D drug from its formulary.
Given that each entity has already created disclosure notices for mass mailings, we estimate that on an annual basis it will take on average, each of the 793 respondents 40 hours to disclose the required notice for a total annual burden of 31,720 hours. The decrease in total annual burden from the estimate previously reported is due to the decreased number of respondents. The estimated annual cost is $1,113,372 ($35.10/hr x 31,720 hr).
Paragraph (b)(3)(iv) requires sponsors to provide enrollees with appropriate notice regarding their transition process within three business days after providing a temporary supply of non-formulary Part D drugs (including Part D drugs that are on a sponsor’s formulary but require prior authorization or step therapy under a sponsor’s utilization management rules). The burden associated with this requirement is the time and effort necessary for a Part D plan sponsor to provide a notice to beneficiaries regarding the transition process. We estimate this will result in 19 million notices that would take an average of 5 minutes (0.083 hours) to prepare. Thus, we estimate the total burden to be 1,577,000 hours. The estimated annual cost is $55,352,700 ($35.10/hr x 1,577,000 hr).
(c)(1) A Part D sponsor must issue and reissue, as necessary, a card or other type of technology to its enrollees to use to access negotiated prices for covered Part D drugs.
The burden associated with this requirement is the time and effort necessary for an entity to provide each enrollee a card. The burden associated with this requirement is reflected in section 423.128.
12.3.9 Dissemination of plan information (§423.128)
(a) A part D sponsor must disclose information about its Part D plan(s) as required by this section to each enrollee of a Part D plan offered by the Part D sponsor under this part and to Part D eligible individuals. The burden associated with this requirement is the time and effort necessary for a Part D sponsor to disclose information and materials about its Part D plan(s). We estimate that it will require 793 respondents 80 hours on an annual basis to prepare the plan materials. We further estimate that, on average, it will require each entity 120 hours on an annual basis to disseminate the required materials to enrollees and eligible individuals for a total annual burden of 158,600 hours. The increase in total annual burden from the previously reported estimate is due to a correction in the number of respondents. The estimated annual cost is $5,566,860 ($35.10/hr x 158,600 hr).
(e) A Part D sponsor must furnish directly to enrollees an explanation of benefits when prescription drug benefits are provided under qualified prescription drug coverage that meets the requirements set forth in this section. The burden associated with this requirement is the time and effort necessary for 793 respondents to provide an explanation of benefits when prescription drug benefits are provided to enrollees. We estimate that it will require each entity 160 hours on an annual basis disseminate the required materials for total annual burden of 126,880 hours. The increase in total annual burden from the previously reported estimate is due to a correction in the number of respondents. The estimated annual cost is $4,453,488 ($35.10/hr x 126,880 hr).
12.3.10 Drug Utilization Management, Quality Assurance, and Medication Therapy Management (MTM) (§423.153)
(b) A Part D plan sponsor or MA organization offering an MA-PD plan must provide CMS with information concerning the procedures and performance of its drug utilization management program, according to guidelines specified by CMS.
The burden associated with this requirement is the time and effort necessary for the Part D plan sponsor or MA organization offering an MA-PD plan to provide CMS with information concerning its drug utilization management program, according to guidelines specified by CMS. We estimate that it will require 793 respondents 30 minutes (0.5 hours) each to provide the required material to CMS for consideration for a total annual burden of 396.5 hours. The increase in total annual burden from the previously reported estimate is due to the increase in the mean wage for a business operations specialist. The estimated annual cost is $13,917 ($35.10/hr x 396.5 hr).
(c) A Part D plan sponsor or MA organization offering an MA-PD plan must provide CMS with information concerning its quality assurance measures and systems, according to guidelines specified by CMS.
The burden associated with this requirement is the time and effort necessary for the Part D plan sponsor or MA organization offering a MA-PD plan to provide CMS with information concerning its quality assurance measures and systems, according to guidelines specified by CMS. We estimate that it will require 793 respondents 30 minutes (0.5 hours) each to provide the required material to CMS for consideration for a total annual burden of 396.5 hours. The increase in total annual burden from the previously reported estimate is due to the increase in the mean wage for a business operations specialist. The estimated annual cost is $13,917 ($35.10/hr x 396.5 hr).
12.3.11 Determination of payment (§423.329)
(b) Part D plan contracts must submit data regarding drug claims to CMS that can be linked at the individual level to Part A and Part B data in a form and manner similar to the process provided under § 422.310 and other information as CMS determines necessary.
The burden associated with this requirement is the time and effort necessary for Part D plan sponsors submit the required claims data to CMS. We estimate that on an annual basis it will take 70stand-alone Part D plan contracts and 117 PACE contracts 52 hours to submit the required documentation to CMS for total annual burden of 9,724 hours. The estimated annual cost is $341,312 ($35.10/hr x 9,724 hr).
(b)(ii) MA organizations that offer MA–PD plans to submit data regarding drug claims that can be linked at the individual level to other data that the organizations are required to submit to CMS in a form and manner similar to the process provided under § 422.310 and other information as CMS determines necessary.
The burden associated with this requirement is the time and effort necessary for MA organizations submit the required claims data to CMS. We estimate that on an annual basis it will take 599 MA contracts 15 hours to submit the required documentation to CMS for total annual burden of 8,985 hours. The estimated annual cost is $315,374 ($35.10/hr x 8,985 hr).
12.3.12 Risk sharing arrangements (§423.336)
A Part D plan sponsor may submit a bid that requests a decrease in the applicable first or second threshold risk percentages or an increase in the percent applied under paragraph (b) of this section.
The burden associated with this requirement is the time and effort necessary for Part D plan sponsors submit the required bid materials to CMS. We estimate that on an annual basis it will take 5 Part D plan sponsors 20 hours to submit the required documentation to CMS for total annual burden of 100 hours. The estimated annual cost is $3,510 ($35.10/hr x 100 hr).
(c) Within 6 months of the end of a coverage year, the Part D plan must provide the information that CMS requires.
The burden associated with this requirement is the time and effort necessary for Part D plan sponsors submit the required cost data to CMS. We estimate that on an annual basis it will take each of the 793 Part D plan sponsors 10 hours per month to submit the required documentation to CMS for total annual burden of 95,160 hours. The estimated annual cost is $3,340,116 ($35.10/hr x 95,160 hr).
12.3.13 Retroactive adjustments and reconciliations (§423.343)
(c) Within 6 months of the end of a coverage year, the Part D plan must provide the information that CMS requires.
The burden associated with this requirement is the time and effort necessary for Part D only sponsors to submit the required data to CMS. We estimate that on an annual basis it will take each of the 793 Part D plan sponsors 10 hours to submit the required documentation to CMS for total annual burden of 7,930 hours. The estimated annual cost is $278,343 ($35.10/hr x 7,930 hr).
(d) Within 6 months of the end of a coverage year, the Part D plan must provide the information that CMS requires.
The burden associated with this requirement is the time and effort necessary for Part only sponsors to submit the required cost data to CMS. We estimate that on an annual basis it will take each of the 793 Part D plan sponsors10 hours to submit the required documentation to CMS for total annual burden of 7,930 hours. The estimated annual cost is $278,343 ($35.10/hr x 7,930 hr).
12.3.14 Coordination of benefits with other providers of prescription drug coverage (§423.464)
(f) A Part D sponsor must exclude expenditures for covered Part D drugs made by insurance or otherwise, a group health plan, or other third party payment arrangements, including expenditures by plans offering other prescription drug coverage for purposes of determining whether a Part D plan enrollee has satisfied the out-of-pocket threshold provided under §423.104(d)(5)(iii). To ensure that this requirement is met, A Part D enrollee must disclose all these expenditures to a Part D plan in accordance with requirements under §423.32(b)(ii).
The burden associated with this requirement is the time and effort necessary for a Part D enrollee to disclose all these expenditures to a Part D plan in accordance with requirements under §423.32(b)(ii). The burden associated with this requirement is captured and discussed above under §423.32(b).
12.3.15 Contract provisions (§423.505)
(d) The Part D sponsor agrees must maintain for 10 years books, records, documents, and other evidence of accounting procedures and practices that are sufficient to meet the requirements set forth in this section.
The burden associated with this requirement is the time and effort necessary for Part D sponsors and MA organizations to maintain the required documentation outlined in this section. We estimate that on an annual basis it will take 793 respondents 52 hours to maintain the required documentation on an annual basis, for total annual burden of 41,236 hours. The estimated annual cost is $1,447,384 ($35.10/hr x 41,236 hr).
(f) The Part D sponsor must submit to CMS certified financial information that must include the requirements set forth in this section.
The burden associated with this requirement is the time and effort necessary for Part D sponsors and MA organizations to submit the required certified data to CMS. We estimate that on an annual basis it will take 793 respondents 8 hours to submit the required documentation to CMS for total annual burden of 6,344 hours. The estimated annual cost is $222,674 ($35.10/hr x 6,344 hr).
12.3.16 Novation agreement requirements (§423.552)
(a) Discusses the conditions for CMS approval of a novation agreement. This paragraph requires the Part D plan sponsor to notify CMS at least 60 days before the date of the proposed change of ownership and requires them to provide CMS with updated financial information and a discussion of the financial solvency impact of the change of ownership on the surviving organization.
The burden associated with this requirement is discussed above in §423.551 of the PRA section.
12.3.17 General Provisions (§423.562)
(a) A Part D plan sponsor must ensure that all enrollees receive written information about the grievance, coverage determination, and appeals procedures that are available to and the information must satisfy the requirements set forth in this section.
The burden associated with this requirement is the time and effort necessary for each of the 793 Part D plan sponsors to disclose the necessary information to enrollees. We estimate that it will require each of the 793 Part D plan sponsors 8 hours on an annual basis to disclose the information for a total annual burden of 6,344 hours. The estimated annual cost is $222,674 ($35.10/hr x 6,344 hr).
12.3.18 Grievance procedures (§423.564)
(e) A Part D plan sponsor must notify the enrollee of its decision as expeditiously as the case requires, based on the enrollee's health status, but no later than 30 days after the date the plan sponsor receives the oral or written grievance.
The burden associated with this requirement is the time and effort necessary for Part D plan sponsors to notify an enrollee of its decision as expeditiously as the case requires, based on the enrollee's health status, but no later than 30 days after the date the plan receives the oral or written grievance. We estimate that 793 Part D plan sponsors will provide notification of 55,334 grievance decisions. The Part D plan must provide written notification of the decision if the grievance was submitted in writing, if the enrollee requests a written response, or if the grievance relates to a quality of care issue. We estimate that the plan sponsor will have to provide written notification to enrollees in 13,200 grievances and oral notification in 118,800 grievances. We estimate it will take 30 minutes (0.5 hours) to provide written notification for a total annual burden of 6,600 hours. We estimate it will take 15 minutes (0.25 hours) to provide oral notification to enrollees for a total annual burden of 29,700 hours. The total number of hours is 36,300 (6,600 + 29,700) annually. The estimated annual cost is $1,274,130 ($35.10/hr x 36,300 hrs).
(g) The Part D plan must maintain records on all grievances received both orally and in writing, including, at a minimum, the date of receipt, final disposition of the grievance, and the date that the Part D plan notified the enrollee of the disposition.
The burden associated with this requirement is the time and effort necessary for Part D plans to maintain the required documentation outlined in this section. We estimate that on an annual basis it will take 793 Part D plan sponsors 52 hours to maintain the required documentation on an annual basis, for a total annual burden of 41,236 hours. The estimated annual cost is $1,447,384 ($35.10/hr x 41,236 hrs).
12.3.19 Standard timeframe and notice requirements for coverage determinations (§423.568)
(a)(3) A Part D plan sponsor must accept requests for benefits orally or in writing and must establish and maintain a method of documenting all oral requests for standard coverage determinations and retain the documentation in the case file.
The burden associated with this requirement is the time and effort necessary for Part D plan sponsors to document oral requests and retain the documentation in the case file. We estimate that Part D plan sponsors will receive about 3,675,000 standard coverage determination requests annually and, of that number, 1,837,500 will be oral requests. We estimate that it will take a Part D plan sponsor 3 minutes (0.05 hours) to document and retain the required documentation in the case file. Thus, we estimate that it will take 793 Part D plan sponsors a total of 91,875 hours to perform this function on an annual basis. The estimated annual cost is $3,224,813 ($35.10/hr x 91,875 hrs).
(b), (c), (d) and (f) When a party makes a request for a drug benefit, a Part D plan sponsor must notify the enrollee in writing of favorable and unfavorable decisions. Enrollees (and the enrollee’s prescriber, as appropriate) must be notified of a coverage decision as expeditiously as the enrollee’s health condition requires, but no later than 72 hours after receipt of the request, or, for an exceptions request, the physician's or other prescriber’s supporting statement. For payment requests, the plan sponsor must notify the enrollee of its decision and make any applicable payment no later than 14 calendar days after receiving the request.
The burden associated with this requirement is the time and effort necessary for the 793 Part D plan sponsors to provide written notice to the enrollee. We estimate it will take a plan sponsor 15 minutes (0.25 hours) to issue a written denial notice in 1,139,250 cases for a total estimate of 284,813 hours. We estimate it will take a plan sponsor 15 minutes (0.25 hours) to issue a written notice for 2,535,750 favorable decisions for a total estimate of 633,938 hours.
The total number of hours is 918,751 (284,813 + 633,938) annually. The estimated annual cost is $32,248,160 ($35.10/hr x 918,751 hrs).
12.3.20 Expediting certain coverage determinations (§423.570)
(c)(2) A Part D plan sponsor must document all oral requests in writing and maintain the documentation in the case file. The burden associated with this requirement is the time and effort necessary for Part D plans to maintain the required documentation outlined in this section. We estimate that on an annual basis Part D plan sponsors will receive 1,225,000 expedited coverage determination requests, of which 1,163,750 will be received orally. We estimate it will take 3 minutes (0.05 hours) for a plan sponsor to document an oral request for an expedited coverage determination. Thus, it will take 793 Part D plan sponsors 58,188 hours to perform this function on an annual basis. The estimated annual cost is $2,042,399 ($35.10/hr x 58,188 hrs).
(d) If a Part D plan denies a request for expedited determination, it must give the enrollee prompt oral notice of the denial and subsequently deliver, within 3 calendar days, a written letter that explains the notice requirements set forth in this section.
The burden associated with this requirement is the time and effort necessary for each of the 793 Part D plan sponsors to disclose the necessary information to an enrollee. We estimate that 12,250 expedited requests will be transferred to the standard adjudication process. We estimate that it will take plan sponsors 15 minutes (0.25 hours) to provide this notice, for a total annual burden of 3,063 hours. The estimated annual cost is $107,511 ($35.10/hr x 3,063 hrs).
12.3.21 Timeframes and notice requirements for expedited coverage determinations (§423.572)
(a) and (c) A Part D plan sponsor must notify the enrollee (and the prescribing physician or other prescriber involved, as appropriate) of its decision, whether adverse or favorable, as expeditiously as the enrollee’s health condition requires, but no later than 24 hours after receiving the request, or, for an exceptions request, the physician's or other prescriber’s supporting statement. Plan sponsors must notify enrollees in writing of favorable and unfavorable expedited coverage determinations.
The burden associated with this requirement is the time and effort necessary for each of the 793 Part D plan sponsors to disclose the necessary information to an enrollee and prescribing physician or other prescriber involved. We estimate it will take 15 minutes (0.25 hours) to provide notice of 1,212,750 expedited coverage determination decisions for a total estimated annual burden of 303,188 hours. The estimated annual cost is $10,641,899 ($35.10/hr x 303,118 hrs).
12.3.22 Exceptions process (§423.578)
Exception requests must be supporting by a statement from the enrollee’s prescriber and if the supporting statement is provided orally, a Part D plan sponsor may require a written follow-up. The burden associated with this requirement is the time and effort necessary for a prescribing physician or other prescriber to submit the written supporting statement or other medical documentation to the Part D plan sponsor. We estimate 2,388,750 requests will require written documentation and that it will take the physician or other prescriber 15 minutes (0.25 hours) to provide the supporting documentation. Therefore, we estimate a total annual burden of 597,188 hours. The estimated annual cost is $54,481,461 ($91.23/hr x 597,188 hrs).
12.3.23 Administration of subsidy program (§423.800)
Paragraph (b) of this section requires the Part D plan sponsor offering the Part D plan, or the MA organization offering the MA-PD plan, to reduce the individual’s premiums and cost-sharing as applicable and provide information to CMS on the amount of such reductions, in a manner determined by CMS. This paragraph also requires the Part D plan sponsor offering the Part D plan to maintain documentation to track the application of the low-income cost-sharing subsidies to be applied to the out-of-pocket threshold.
The burden associated with these requirements is the time and effort for the Part D plan sponsor offering the Part D plan to provide information to CMS and to maintain documentation. We estimate that it will take each of the 793 respondents approximately 52 hours on an annual basis to provide the information to CMS. We also estimate that it will take approximately 26 hours for each of the 793 respondents to maintain the information for tracking purposes. Therefore, we estimate a total annual burden of 61,854 hours to comply with these requirements. The estimated annual cost is $2,171,075 ($35.10/hr x 61,854 hr).
12.3.24 Change in Ownership (§423.892)
(c) A sponsor who is contemplating or negotiating a change of ownership must notify CMS. We estimate that approximately 1 percent of sponsors will fall into this category in a given year.
The burden associated with this requirement is the time and effort necessary for a sponsoring entity to submit the required notification to CMS. On an annual basis it will take 50 entities (1 percent of 5,000) about one hour (60 minutes) to submit the required notification to CMS, for a total of approximately 50 hours. The estimated annual cost is $1,755 ($35.10/hr x 50 hr).
Burden Summary (Subtotal)
CFR Section |
Respondent Type |
# Respondents |
Time (hr per response) |
# Responses (per respondent) |
Total Responses (all respondents) |
Total Annual Time (all respondents) |
423.32(d) |
Private Sector |
793 |
3 |
2 |
1,586 |
4,758 |
|
|
|
0.017 (1 min) |
4,986 |
3,954,0000 |
62,218 |
423.34(e) |
Private Sector |
793 |
0.25 |
164 |
130,000 |
32,500 |
423.36(b) |
Private Sector |
793 |
1.017 |
32401 |
1,903,752 |
33,157 |
423.44(b) |
Private Sector |
793 |
1 |
1 |
793 |
793 |
|
|
|
0.1 (6 min) |
626 |
496,344 |
49,634 |
|
|
|
1 |
1 |
793 |
793 |
|
|
|
0.017 (1 min) |
1.4 |
1,100 |
18.7 |
|
|
|
1 |
1 |
793 |
793 |
|
|
|
0.1 (6 min) |
22 |
17,772 |
1,777 |
423.46(b) |
Private Sector |
793 |
0.25 |
4,986 |
3,954,000 |
988,500 |
423.46(d) |
Private Sector |
793 |
0.083 (5 min) |
4,986 |
3,954,000 |
328,182 |
423.48 |
Private Sector |
793 |
2 |
1 |
793 |
1,586 |
423.104(g) |
Private Sector |
793 |
10 |
1 |
793 |
7,930 |
423.120(b) |
Private Sector |
793 |
2 |
1 |
793 |
1,586 |
|
|
|
40 |
1 |
793 |
31,720 |
|
|
|
0.083 (5 min) |
1 |
19,000,000 |
1,577,000 |
423.128(a) |
Private Sector |
793 |
200 |
1 |
793 |
158,600 |
423.128(e) |
Private Sector |
793 |
160 |
1 |
793 |
126,880 |
423.153(b) |
Private Sector |
793 |
0.5 |
1 |
793 |
396.5 |
423.153(c) |
Private Sector |
793 |
0.5 |
1 |
793 |
396.5 |
423.329(b) |
Private Sector |
187 |
52 |
1 |
187 |
9,724 |
|
|
599 |
15 |
1 |
599 |
8,985 |
423.336(a) |
Private Sector |
5 |
20 |
1 |
5 |
100 |
423.336(c) |
Private Sector (Contracts) |
793 |
10/month |
12 |
9,516 |
95,160 |
423.343(cc) |
Private Sector (Contracts) |
793 |
10 |
1 |
793 |
7,930 |
423.343(d) |
Private Sector (Contracts) |
793 |
10 |
1 |
793 |
7,930 |
423.505(d) |
Private Sector |
793 |
52 |
1 |
793 |
41,236 |
423.505(f) |
Private Sector |
793 |
8 |
1 |
793 |
6,344 |
423.562(a) |
Private Sector |
793 |
8 |
1 |
793 |
6,344 |
423.564(e) |
Private Sector |
793 |
0.5 |
16.6 |
13,200 |
6,600 |
|
|
|
0.25 |
149.8 |
118,800 |
29,700 |
423.564(g) |
Private Sector |
793 |
52 |
1 |
793 |
41,236 |
423.568(a)(3) |
Private Sector |
793 |
0.05 (3 min) |
2,317 |
1,837,500 |
91,875 |
423.568(b), (c), (d), and (f) |
Private Sector |
793 |
0.25 |
1436.6 |
1,139,250 |
284,813 |
|
|
|
0.25 |
3,197.7 |
2,535,750 |
633,938 |
423.570(c)(2) |
Private Sector |
793 |
0.05 (3 min) |
1,467.5 |
1,163,750 |
58,188 |
423.570(d) |
Private Sector |
793 |
0.25 |
15.4 |
12,250 |
3,063 |
423.572(a) and (c) |
Private Sector |
793 |
0.25 |
1,529.3 |
1,212,750 |
303,188 |
423.578(a) and (b) |
Private Sector |
|
0.25 |
|
2,388,750 |
597,188 |
423.800(b) |
Private Sector |
793 |
78 |
1 |
793 |
61,834 |
423.892(cc) |
Private Sector |
50 |
1 |
1 |
50 |
50 |
Subtotal |
793 |
-- |
-- |
43,859,185 |
5,703,872 |
|
12.4 ICRs Regarding State Eligibility Determinations [423.904(b)] and Reporting [423.910(d)]
There have been no updates to the ICRs in this section.
12.4.1 Eligibility determinations for low-income subsidies (§423.904)
Paragraph (b) of this section states the State agency must inform CMS of cases where eligibility is established or redetermined.
The burden associated with the requirement on State agencies to inform CMS of cases where eligibility is established or redetermined is estimated to total approximately 6,120 annual hours. We estimate that there will be approximately 600,000 of these cases on an annual basis. We also estimate that it will take approximately 10 hours per month for the State agency to inform CMS of these cases.
Paragraph (d) of this section requires States to make available--low-income subsidy application forms, information on the nature of, and eligibility requirements for the subsidies under this section, and offer assistance with the completion of the application forms. States must require an individual or personal representative applying for the low-income subsidy to complete all required elements, provide documents as necessary, and certify as to the accuracy of the information provided. In addition, States must provide CMS with other information as specified by CMS that may be needed to carry out the requirements of the Part D prescription drug benefit.
The burden associated with the requirement on States to require the applicant of the low-income subsidy to complete all required elements, to provide documents, and to certify as to the accuracy of the information is subject to the PRA; however, the burden associated with this requirement is discussed in §423.774 above.
The burden associated with the requirement on States to provide CMS with other information as specified by CMS is estimated to total approximately 1,020 annual hours. Based on the experience to date, it will take on average 20 hours per State on an annual basis to provide CMS with the specified information.
12.4.2 Requirements (§423.910)
(d) The subpart also requires States to submit an electronic file, in a manner specified by the Secretary, identifying each full benefit dual eligible beneficiary enrolled in the State for each month with Part D drug coverage who is also determined to be full benefit eligible by the State for full Medicaid benefits.
The burden associated with the requirement on States to submit an electronic file identifying each full benefit dual eligible enrolled in the State for each month with Part D drug coverage is estimated to total approximately 120 hours per State on an annual basis. We estimate that it will take approximately 10 hours for each State to submit an electronic file on a monthly basis. Therefore, we estimate a total burden of 6,120 hours on an annual basis. The estimated annual cost is $214,812 ($35.10/hr x 6,120 hr).
Burden Summary (Subtotal)
CFR Section |
Respondent Type |
# Respondents |
Time (hr per response) |
# Responses (per respondent) |
Total Responses (all respondents) |
Total Annual Time (all respondents) |
423.904(b) |
State |
51 |
10/month |
12,000 |
600,000 |
6,120 |
|
|
|
20 |
1 |
51 |
1,020 |
423.910(d) |
State |
51 |
10/month |
12 |
51 |
6,120 |
Subtotal |
51 |
-- |
-- |
600,102 |
13,260 |
|
12.5 ICRs Exempt from the Requirements of the Paperwork Reduction Act
In §423.168(c), an accreditation organization approved by CMS must provide to CMS in written form and on a monthly basis copies of accreditation surveys, notices of accreditation decisions, notice of all complaints, information about any remedial or adverse action taken, and notice of any proposed changes to accreditation standards, requirements or survey processes.
In §423.171(a), a private, national accreditation organization applying for approval must furnish to CMS all of the information and materials set forth in this part.
In §423.507(a), if a Part D sponsor does not intend to renew its contract, it must notify CMS in writing by the first Monday of June in the year in which the contract ends and notify, in an manner that meets the requirements of this section, each Medicare enrollee, at least 90 days before the date on which the nonrenewal is effective.
In §423.508(b), if the contract is terminated by mutual consent, the Part D sponsor must provide notice to its Medicare enrollees and the general public as provided in paragraph (c) of this section.
In §423.509(b), if CMS notifies the Part D sponsor in writing 90 days before the intended date of their termination the Part D plan sponsor must notify its Medicare enrollees of the termination by mail at least 30 days before the effective date of the termination. The Part D sponsor must also notify the general public of the termination at least 30 days before the effective date of the termination by publishing a notice in one or more newspapers of general circulation in each community or county located in the Part D sponsor's service area.
In §423.510(a), if a Part D sponsor terminates its contract because CMS fails to substantially carry out the terms of the contract the Part D sponsor must give advance notice to CMS, its Medicare enrollees, and the general public in a manner that meets the requirements set forth in the section.
In §423.551(c), states that a Part D plan sponsor that has a Medicare contract in effect under §423.502 of this part and is considering or negotiating a change in ownership must notify CMS at least 60 days before the anticipated effective date of the change. The Part D plan sponsor must also provide updated financial information and a discussion of the financial and solvency impact of the change of ownership on the surviving organization.
In §423.552(a), Part D plan sponsors are required to submit to CMS, at least 30 days before the proposed change of ownership date, 3 signed copies of the novation agreement containing the provisions specified in this section, and 1 copy of other relevant documents required by CMS.
In §423.859(c), states that CMS may waive or modify the requirements of this part if an entity seeking to become a prescription drug plan in an area such, as a territory, other than the 50 States or the District of Columbia requests waiver or modification of any Part D in order to provide qualified prescription drug. The burden associated with this requirement is the time and effort for the Part D plan to make a request of waiver or modification to CMS. We estimate that approximately 2 Part D plans will request a waiver or modification on an annual basis.
Section 423.863(a) discusses the process CMS uses for the solicitation and approval of bids. CMS solicits bids from eligible fallback entities for the offering in all fallback service areas in one or more Part D plan regions of a fallback prescription drug plan. CMS specifies the form and manner in which fallback bids are submitted in separate guidance to bidders. The burden associated with this requirement is the time and effort for the fallback entities to prepare and submit a bid that meets the requirements of the section and related sections. We estimate fewer than 10 fallback entities will submit a bid every three years.
Section 423.863(b) discusses the procedures CMS uses to enter into contracts. CMS solicits bids from eligible fallback entities and uses competitive procedures to enter into contracts. The burden associated with this requirement is the time and effort for the fallback entities to enter into a contract with CMS that meets the requirements of this section and related sections. We estimate, as an upper limit, that approximately 5 fallback entities will enter into a contract with CMS on an annual basis.
Section 423.871(f) states that each contract for a fallback prescription drug plan requires an eligible fallback entity offering a fallback prescription drug plan to provide CMS with the information CMS determines is necessary to carry out the requirements of this section. The burden associated with this requirement is the time required of the fallback prescription drug plan to provide CMS with the information CMS determines necessary. We estimate that approximately 5 fallback prescription drug plans will enter into a contract with CMS.
Section 423.907(a) discusses the requirements on territories to submit plans for approval by the Secretary to receive increased grants. This paragraph states that a territory may submit a plan to the Secretary under which medical assistance is to be provided to low-income individuals for the provision of covered Part D drugs. Paragraph (b) describes what a plan must include. The burden associated with this requirement is the time and effort of territories to prepare and submit a plan for approval. We estimate that this requirement would affect 5 territories.
12.5.2 The following information collection requirements are associated with an administrative action (see 5 CFR 1320.4(a)(2) and (c)). Consequently, they are exempt from the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
In §423.580, the requirements under Right to a Redetermination.
In §423.582, the requirements under Request for a Standard Redetermination.
In §423.584, the requirements under Expediting Certain Redeterminations.
In §423.590, the requirements under Timeframes and Responsibility for Making redeterminations.
In part 423, the requirements under subpart N (Medicare Contract Determinations and Appeals).
In §423.756(a), CMS will allow the Part D plan sponsor to provide evidence that it has not committed an act or failed to comply with the requirements as described. In addition, CMS may allow additional time for the Part D plan sponsor to provide the evidence if the Part D plan sponsor sends a written request providing a credible explanation of why additional time is necessary.
12.5.3 We believe the burden associated with the following requirements is exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). Specifically, we believe that the time, effort, and financial resources necessary to comply with the aforementioned requirements would be incurred by pharmacies during the normal course of their activities and, therefore, should be considered usual and customary business practices.
In §423.132(a), a Part D sponsor must require a pharmacy that dispenses a covered Part D drug to inform an enrollee of any differential between the price of that drug and the price of the lowest priced generic version of that covered Part D drug that is therapeutically equivalent and bioequivalent and available at that pharmacy, unless the particular covered Part D drug being purchased is the lowest-priced therapeutically equivalent and bioequivalent version of that drug available at that pharmacy. The information must be provided after the drug is dispensed at the point of sale or, in the case of dispensing by mail order, at the time of delivery of the drug. The burden associated with this requirement is the time and effort necessary for the Part D sponsor to notify the pharmacy of the disclosure requirement referenced in this section and the burden on a pharmacy to provide the necessary disclosure to the enrollee.
In §423.136(c) and (d), for any medical records or other health and enrollment information it maintains with respect to enrollees, a Part D plan sponsor must maintain the records and information in an accurate and timely manner and provide timely access by enrollees to the records and information that pertain to them. The burden associated with this requirement is the time and effort necessary to maintain and disclose enrollee records.
Section 423.904(d) requires States to make available low-income subsidy application forms, information on the nature of, and eligibility requirements for the subsidies under this section, and offer assistance with the completion of the application forms. States must require an individual or personal representative applying for the low-income subsidy to complete all required elements, provide documents as necessary, and certify as to the accuracy of the information provided. In addition, States must provide CMS with other information as specified by CMS that may be needed to carry out the requirements of the Part D prescription drug benefit.
12.5.4 Since the following requirements is associated with an affirmation and certification, the requirements and burden are exempt (5 CFR 1320.3(h)(1)) from the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)
Section 423.505(k)(5) states that the Chief Executive Officer, Chief Financial Officer, or an individual delegated the authority to sign on behalf of one of these officers, and who reports directly to the officer, must certify that the information provided is accurate, complete, and truthful and fully conforms to the requirements in §§423.336 and 423.343 and acknowledge that this information will be used for the purposes of obtaining Federal reimbursement.
12.6 Related ICRs Approved Under Other OMB Control Numbers
12.6.1 Burden for the following collections of information are approved by OMB under control number 0938-0936 (CMS-10137).
In §423.410(e), a Part D plan sponsor applicant may submit a waiver application to CMS to waive certain state licensure and fiscal solvency requirements in order to contract with CMS. The burden associated with this requirement is the time and effort necessary for a Part D plan sponsor applicant to submit a waiver application that meets the requirements of this section.
In §423.458(b), organizations offering or seeking to offer a MA-PD plan may request from CMS in writing waiver or modification of those requirements under this part that are duplicative of, or that are in conflict with provisions otherwise applicable to the plan under Part C.
In §423.458(c), any entity seeking to offer, sponsor, or administer an employer-sponsored group prescription drug plan may request, in writing, a waiver or modification of additional requirements under this Part that hinder its design of, the offering of, or the enrollment in, such employer-sponsored group prescription drug plan.
In §423.458(d), a cost plan (as defined in 42 CFR 417.401) or PACE organization (as defined in 42 CFR 460.6) that offers qualified prescription drug coverage under Part D may request, in writing, a waiver or modification of those requirements under this part otherwise applicable to cost plans or PACE organizations that are duplicative of, or that are in conflict with, provisions otherwise applicable to cost plans under section 1876 of the Act or PACE organizations or under sections 1894 and 1934 of the Act, or as may be necessary in order to improve coordination of this Part with the benefits offered by cost plans or PACE organizations.
In §423.502(b), to become a Part D sponsor an entity or an individual authorized to act for the entity (the applicant), must complete, comply with, and submit a certified application in the form and manner required by CMS that meets the requirements set forth in this section. The burden associated with this requirement is the time and effort necessary for Part D sponsors and MA organizations to submit the required application materials to CMS.
12.6.2 Burden for the following collections of information are approved by OMB under control number 0938-0944 (CMS-10142).
In §423.153(d), to become a Part D sponsor, an applicant must describe in its application how it will take into account the resources used and time required to implement the MTM program it chooses to adopt in establishing fees for pharmacists or others providing MTM services for covered Part D drugs under a prescription drug plan and disclose to CMS upon request the amount of the management and dispensing fees and the portion paid for MTM services to pharmacists and others upon request. Reports of these amounts are protected under the provisions of section 1927(b)(3)(D) of the Act. The burden is captured under §423.265.
In §423.265(a), an applicant may submit a bid that meets the requirements set forth in this section and related sections of this regulation, to become a Part D plan sponsor, to become an MA organization offering an MA-PD plan, or to become a PACE organization offering Part D coverage to Part D eligible PACE participants. The burden associated with this requirement is the time and effort necessary for an entity to submit the required materials to CMS.
12.6.3 Burden for the following collections of information are approved by OMB under control number 0938-0957 (CMS-10156).
In §423.884 (a),(b), (c) and (d), to qualify for the retiree drug subsidy the employer or union sponsor shall file an annual application with CMS that meets the requirements of this section and related sections, for each qualified retiree prescription drug plan maintained, including an attestation as to actuarial value. The burden associated with this requirement is the time and effort necessary for an entity to prepare and submit the application to CMS.
12.6.4 Burden for the following collections of information are approved by OMB under control number 0938-0977 (CMS-10170).
In §423.888 (b) and (c), to receive payment under this section each qualified entity must submit information in a form and manner and at such times provided in this paragraph and under other guidance specified by CMS, by the sponsor or any party designated the sponsor. If a sponsor elects to receive monthly or quarterly retiree subsidy payments or an interim annual retiree subsidy payment, the plan sponsor may submit aggregated gross cost data or estimated premium amounts costs under the cost threshold costs over the cost limit, an estimate of the expected rebates and other price concessions, and any other data CMS may require upon submission of data for payment with a final reconciliation within 15 months after the end of the plan year. For final reconciliation purposes, sponsors must submit actual cost data for the categories of costs in the preceding sentence (they may not submit estimated premium amounts), as well as actual, as opposed to estimated, rebates and other price concessions, within 15 months after the end of the plan year, or by some other date established by CMS. In addition, plan sponsors are required to provide on a monthly basis an update to their retiree list if information associated with their retirees’ changes.
12.6.5 Burden for the following collections of information are approved by OMB under control number 0938-0978 (CMS-10171).
In §423.464(a), the administrative processes referred to in this section of the regulation were established by CMS in a Part D Manual chapter titled “Chapter 14 – Coordination of Benefit Manual. The requirements are approved under the subject control number.
12.6.6 Burden for the following collections of information are approved by OMB under control number 0938-0992 (CMS-10185).
In §423.514, under Validation of Part D Reporting Requirements, the burden estimate for the validation of Part D reporting requirements is under the subject control number.
12.6.7 Burden for the following collections of information are approved by OMB under control number 0938-1013 (CMS-10198).
In §423.56(e), each entity must disclose their creditable coverage status to CMS in the form and manner described by CMS. In January 2006, CMS issued guidance on the form and manner of the disclosure to CMS. Each entity was required to disclose their initial creditable coverage status to CMS in 2006, and within 60 days of the beginning date of their plan year, as well as upon any subsequent change in creditable coverage status. CMS provided an on-line Disclosure to CMS Form CMS-10198 to satisfy this requirement.
12.6.8 Burden for the following collections of information are approved by OMB under control number 0938-0467 (CMS-R-74).
Section 423.774(d) discusses the application requirements for individuals applying for low-income subsidy. Individuals applying for low-income subsidy, or a personal representative applying on the individual’s behalf, must complete all required elements of the application, provide any statements from financial institutions, as requested, to support information in the application, and certify, as to the accuracy of the information provided on the application form. The burden associated with this requirement is the time and effort for the individual or personal representative applying on the individual’s behalf, to complete the low-income subsidy application, provide financial statements as requested and to certify that the information provided is accurate.
12.6.9 Burden for the following collections of information are approved by OMB under control number 0938-0502 (CMS-R-107).
Section §423.910(c) sets forth the requirements for State contributions for Part D drug benefits based on dual eligible drug expenditures. It requires States to submit MSIS data to provide accurate and complete coding to identify the numbers and types of Medicaid and Medicare dual eligibles in their MSIS data submittals. States must provide accurate and complete coding in their MSIS data submittals.
12.7 Total Annual Burden
ICR |
# Respondents |
Time (hr per response) |
# Responses (per respondent) |
Total Responses (all respondents) |
Total Annual Time (all respondents) |
Business Continuity Plans |
99 |
-- |
1 |
99 |
15,920 |
Medicare Prescription Drug Benefit Program (Benes) |
9,869,100 |
-- |
1 |
9,869,100
|
2,847,975 |
Medicare Prescription Drug Benefit Program (PLAN) |
793 |
-- |
-- |
43,859,185 |
5,703,872 |
State Eligibility Determinations |
51 |
-- |
-- |
600,102 |
13,260 |
TOTAL |
9,870,043 |
-- |
-- |
54,328,486 |
8,581,027 |
All states and Part D plan sponsors are fully operational and equipped to fulfill these requirements. Therefore no additional capital or equipment costs will result from the collection of information.
14. Cost to the Federal Government
We estimate that on an annual basis 200 individuals will be required to pay arrearages for Part D-IRMAA to CMS in order to be reinstated. We estimate that it will take a CMS staff person 5 minutes (0.083) to compile the arrearage information and 1 minute (0.017 hours) to assemble and disseminate the notice for each Part D-IRMAA favorable determination. 200 notices x 0.1 hours (6 minutes) = 20 hours. The estimated annual cost is $698. This is based upon the 2015 Washington-Baltimore-Northern VA Locality Pay Area hourly rate for a GS-11/step 6 of $35.62/hr (http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/15Tables/html/DCB_h.aspx) multiplied by the number of burden hours (20).
15. Changes to Burden
ICRs Regarding Business Continuity Plans
This is a revision of an approved collection. We are adding a new burden to reflect business continuity requirements finalized in §§ 422.504(o) and 423.505(p).
423.505(p) combined with 422.504(o) |
Contracts |
Respondents |
Time (hr per response) |
# responses (per respondent) |
Total Responses |
Time (aggregate) |
28 MAOs and/or Part D sponsors (entities) with no BCP |
240 |
1 |
28 |
6,720 |
||
57 entities revising an existing BCP |
120 |
1 |
57 |
6,840 |
||
85 (year 1) contracts |
360 hr (per response) |
2 |
85 responses (aggregate) |
13,560 hours |
||
9 new entities each year will not have a BCP and will need to create |
240 |
1 |
9 |
2,160 |
||
5 entities with an existing BCP will need to revise (these respondents could already be counted above) |
40 |
1 |
5 |
200 |
||
|
|
9 (subsequent years) contracts |
280 hr (per response) |
2 |
14 responses (aggregate) |
2,360 hours |
The revision will add 15,920 hours (13,650 + 2,360).
ICRs Regarding Medicare Prescription Drug Benefit Program (Beneficiaries)
We decreased the burden that was already reported and approved to reflect recent CMS experience.
CFR Section |
Hours |
Costs |
Reason for Change |
||||
Previous |
Revised |
Difference |
Previous |
Revised |
Difference |
|
|
423.32(a) and (b) |
2,000,000 |
1,975,000 |
25,000 |
--- |
--- |
N/A |
Revised estimate reflects recent CMS experience |
423.32(b) |
--- |
--- |
N/A |
--- |
--- |
N/A |
|
423.34(e) |
--- |
--- |
N/A |
--- |
--- |
N/A |
|
423.56(f) |
100,000 |
100 |
99,900 |
--- |
--- |
N/A |
Revised estimate reflects recent CMS experience |
423.578(a) and (b) |
--- |
--- |
N/A |
--- |
--- |
N/A |
|
ICRs Regarding Medicare Prescription Drug Benefit Program (Plans)
There are changes to the previously reported and approved burden that are due to: improved estimates based on recent CMS experience; increased labor costs; a decreased number of Part D sponsors; and the correction of errors in previously reported data. Additionally, although burden hours reported for several requirements in this ICR, the costs were inadvertently omitted; this package corrects that omission by including these cost estimates. Finally, the burden in this ICR is being reduced to reflect three requirements that are no longer subject to the PRA and were discontinued as of December 31, 2011 (CMS-10182).
CFR Section |
Hours |
Costs |
Reason for Change |
||||
Previous |
Revised |
Difference |
Previous |
Revised |
Difference |
|
|
423.32(d) |
73,112 |
73,296 |
184 |
2,273,783 |
2,526,358 |
252,575 |
Recent CMS experience; a decreased number of Part D sponsors; and increased labor costs |
423.34(e) |
--- |
--- |
N/A |
1,017,575 |
1,140,750 |
123,175 |
A decreased number of Part D sponsors and increased labor costs |
423.36(b) |
10,646 |
33,157 |
22,511 |
333,326 |
1,163,811 |
830,485 |
Recent CMS experience; a decreased number of Part D sponsors; and increased labor costs |
423.44(b) |
25,306 |
517,595 |
492,289 |
563,548 |
1,888,686 |
1,325,138 |
Recent CMS experience; a decreased number of Part D sponsors; and increased labor costs |
|
|
|
|
|
|
|
|
423.46(b) |
125,000 |
988,500 |
863,500 |
3,913,750 |
34,696,350 |
30,482,600 |
Recent CMS experience; a decreased number of Part D sponsors; and increased labor costs |
423.46(d) |
41,667 |
328,182 |
286,515 |
1,304,583 |
11,519,188 |
10,214,605 |
Recent CMS experience; a decreased number of Part D sponsors; and increased labor costs |
423.48 |
1,704 |
1,586 |
(118) |
53,353 |
55,669 |
2,316 |
A decreased number of Part D sponsors and increased labor costs |
423.56(f) |
174,642 |
0 |
(174,642) |
5,468,041 |
0 |
(5,468,041) |
Discontinued and not subject to the PRA |
423.104(g) |
8,520 |
7,930 |
(590) |
266,761 |
278,343 |
11,582 |
A decreased number of Part D sponsors and increased labor costs |
423.120(b) |
1,612,784 |
1,610,306 |
(2,478) |
50,496,267 |
56,521,741 |
6,025,474 |
A decreased number of Part D sponsors and increased labor costs |
423.128(a) |
149,000 |
158,600 |
9,600 |
4,665,190 |
5,566860 |
901,670 |
Correction to the number of Part D sponsors and increased labor costs |
423.128(e) |
119,200 |
126,880 |
7,680 |
3,732,152 |
4,453,488 |
721,336 |
Correction to the number of Part D sponsors and increased labor costs |
423.153(b) |
426 |
396.5 |
29.5 |
13,338 |
13,917 |
579 |
A decreased number of Part D sponsors and increased labor costs |
423.153(c) |
426 |
396.5 |
29.5 |
13,338 |
13,917 |
579 |
A decreased number of Part D sponsors and increased labor costs |
423.329(b) |
19,588 |
18,709 |
(879) |
--- |
656,686 |
656,686 |
A decreased number of Part D sponsors and correction of omission of cost data |
423.336(a) |
--- |
--- |
N/A |
--- |
3,510 |
3,510
|
Correction of omission of cost data |
423.336(c) |
104,640 |
95,160 |
9,480 |
--- |
3,340,116 |
3,340,116
|
A decreased number of Part D sponsors and correction of omission of cost data |
423.343(c) |
8,720 |
7,930 |
(790) |
--- |
278,343 |
278,343
|
A decreased number of Part D sponsors and correction of omission of cost data |
423.343(d) |
8,720 |
7,930 |
(790) |
--- |
278,343 |
278,343
|
A decreased number of Part D sponsors and correction of omission of cost data |
423.505(d) |
44,304 |
41,236 |
(3,068) |
1,387,158 |
1,447,384 |
60,226 |
A decreased number of Part D sponsors and increased labor costs |
423.505(f) |
6,816 |
6,344 |
(472) |
213,409 |
222,674 |
9,265 |
A decreased number of Part D sponsors and increased labor costs |
423.562(a) |
3,392 |
6,344 |
2,952 |
--- |
222,674 |
222,674
|
Correction to the number of Part D sponsors |
423.564(e) |
--- |
--- |
N/A |
--- |
1,274,130 |
1,274,130
|
Correction of omission of cost data |
423.564(g) |
22,048 |
41,236 |
19,188 |
--- |
1,447,384 |
1,447,384
|
Correction to the number of Part D sponsors and correction of omission of cost data |
423.568(a)(3) |
--- |
--- |
N/A |
--- |
3,224,813 |
3,224,813
|
Correction of omission of cost data |
423.568(b), (c), (d), and (f) |
--- |
--- |
N/A |
--- |
32,248,160 |
32,248,160 |
Correction of omission of cost data |
423.570(c)(2) |
--- |
--- |
N/A |
--- |
2,042,399 |
2,042,399
|
Correction of omission of cost data |
423.570(d) |
--- |
--- |
N/A |
--- |
107,511 |
107,511
|
Correction of omission of cost data |
423.572(a) and (c) |
--- |
--- |
N/A |
--- |
10,641,899 |
10,641,899 |
Correction of omission of cost data |
423.578(a) and (b) |
--- |
--- |
N/A |
--- |
54,481,461 |
54,481,461 |
Correction of omission of cost data |
423.800(b) |
66,456 |
61,834 |
(4,622) |
2,080,732 |
2,171,075 |
90,343 |
A decreased number of Part D sponsors and increased labor costs |
423.892(cc) |
--- |
--- |
N/A |
--- |
1,755 |
1,755 |
Correction of omission of cost data |
ICRs Regarding State Eligibility Determinations and Reporting
There is no change to the burden that was already reported and approved.
We are also correcting the iteration that was approved by OMB on February 6, 2014 (ICR ref # 201312-0938-021) by removing Attachments 1a and 1b; 2a and 2b; 3; 4; and 5a, 5b, and 5c.. All of the attachments should have been removed since the marketing requirements had been moved to a separate PRA package.
This 2015 iteration does not propose any marketing-related burden adjustments since the associated burden was removed from this package and was accounted for and approved in OMB #0938-1051.
16. Publication and Tabulation Dates
There are no publication or tabulation dates. Subsequent PRA packages may include these requirements, which will be addressed, as required, when packages are submitted to OMB for approval.
17. Expiration Date
Three years from the date of OMB approval.
18. Certification Statement
There are no exceptions to the certification statement.
B. Collections of Information Employing Statistical Methods
Not applicable.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Supporting Statement For Collection Requirements pertaining to the Medicare Prescription Drug Benefit Program |
| Author | CMS |
| File Modified | 0000-00-00 |
| File Created | 2021-01-24 |