[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Notices]
[Pages 32659-32661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12950]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-367, CMS-10279, CMS-10483, CMS-301, CMS-317, 
CMS-319, CMS-10178 and CMS-10307]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS) is publishing the following summary of proposed 
collections for public comment. Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: The 
necessity and utility of the proposed information collection for the 
proper performance of the agency's functions; the accuracy of the 
estimated burden; ways to enhance the quality, utility, and clarity of 
the information to be collected; and the use of automated collection 
techniques or other forms of information technology to minimize the 
information collection burden.
    1. Type of Information Collection Request: Extension without change 
of a currently approved collection. Title of Information Collection: 
Medicaid Drug Program Monthly and Quarterly Drug Reporting Format; Use: 
Labelers transmit drug data to CMS within 30 days after the end of each 
calendar month and quarter. We calculate the unit rebate amount (URA) 
for each National Drug Code and distribute to all state Medicaid 
agencies. States use the URA to invoice the labeler for rebates. The 
monthly data is used to calculate Federal Upper Limit prices for 
applicable drugs and for states that opt to use this data to establish 
their pharmacy reimbursement methodology. Form Number: CMS-367 (OCN: 
0938-0578); Frequency: Monthly and quarterly; Affected Public: Private 
sector (business or other for-profits); Number of Respondents: 590; 
Total Annual Responses: 9,440; Total Annual Hours: 139,712. (For policy 
questions regarding this collection contact Cindy Bergin at 410-786-
1176. For all other issues call 410-786-1326.)
    2. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Ambulatory Surgical Center Conditions for Coverage; Use: 
The Ambulatory Surgical Center (ASC) Conditions for Coverage (CfCs) 
focus on a patient-centered, outcome-oriented, and transparent 
processes that promote quality patient care. The CfCs are designed to 
ensure that each facility has properly trained staff to provide the 
appropriate type and level of care for that facility and provide a safe 
physical environment for patients. The CfCs are used by federal or 
state surveyors as a basis for determining whether an ASC qualifies for 
approval or re-approval under Medicare. We, along with the healthcare 
industry, believe that the availability to the facility of the type of 
records and general content of records, which this regulation 
specifies, is standard medical practice and is necessary in order to 
ensure the well-being and safety of patients and professional treatment 
accountability. Form Number: CMS-10279 (OCN: 0938-1071); Frequency: 
Annual; Affected Public: Business or other for-profit, Not-for-profit 
institutions; Number of Respondents: 5,300; Total Annual Responses: 
5,300; Total Annual Hours: 206,700. (For policy questions regarding 
this collection contact Jacqueline Leach at 410-786-4282. For all other 
issues call 410-786-1326.)
    3. Type of Information Collection Request: New Collection (Request 
for a new control number); Title of Information Collection: Evaluation 
of the Multi-Payer Advanced Primary Care Practice (MAPCP) 
Demonstration: Conduct Beneficiary Experience with Care Surveys; Use: 
On September 16, 2009, the Department of Health and Human Services 
announced the establishment of the Multi-payer Advanced Primary Care 
Practice (MAPCP) Demonstration, under which Medicare joined Medicaid 
and private insurers as a payer participant in state-sponsored patient-
centered medical home (PCMH) initiatives. We selected eight states to 
participate in this demonstration: Maine, Vermont, Rhode Island, New 
York, Pennsylvania, North Carolina, Michigan, and Minnesota.
    We are conducting a survey to assess the care experiences of 
beneficiaries involved in the MAPCP Demonstration. We have chosen to 
measure patient experience using a validated, standardized survey 
questionnaire, the PCMH version of the Consumer Assessment of 
Healthcare Providers and Systems (PCMH-CAHPS). The PCMH-CAHPS is a 
validated, federally developed instrument that measures patient 
experience in 6 domains (access to care, provider communication, office 
staff interactions, attention to medical/emotional health, health care 
support, and medication decisions). Form Number: CMS-10483 (OCN: 0938-
NEW); Frequency: Annually; Affected Public: Individuals and households; 
Number of Respondents: 10,038; Total Annual Responses: 10,038; Total 
Annual Hours: 3,313. (For policy questions regarding this collection 
contact Suzanne Goodwin at 410-786-0226. For all other issues call 410-
786-1326.)
    4. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Certification of Medicaid Eligibility Quality Control (MEQC) Payment 
Error Rates; Use: We conduct these to determine whether or not the 
sampled cases meet applicable state Title XIX or XXI eligibility 
requirements when applicable. The reviews are also used to assess 
beneficiary liability, if any, and to determine the amounts paid to 
provide Medicaid services for these cases. In the Medicaid Eligibility 
Quality Control (MEQC) system, sampling is the only practical method of 
validating eligibility of the total caseload and determining the dollar 
value of eligibility liability errors. Any attempt to make such 
validations and determinations by reviewing every case would be an 
enormous and unwieldy undertaking. During each 6-month review period 
states are required to collect data on eligibility payment error 
dollars and paid claims dollars for each case in the sample. States 
must also identify cases for which a review cannot be conducted. At the 
conclusion of the 6-month review period, states must complete the 
Payment Error Rate form which contains aggregate data on sample size, 
number of sampled cases dropped, and number of sampled cases listed in 
error. These data, along with the calculated eligibility payment error 
rate and lower limit are certified by the State Medicaid Director (or 
designee) and submitted to the Regional Office. The collection of 
information is also necessary to implement provisions from the 
Children's Health Insurance Program Reauthorization Act of 2009 
(CHIPRA) (Pub. L. 111-3) with regard to the MEQC and Payment Error Rate 
Measurement (PERM) programs. Form Number: CMS-301 (OCN: 0938-0246); 
Frequency: Semi-Annually; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 51; Total Annual Responses: 102; 
Total Annual Hours: 16,446. (For policy questions regarding this 
collection contact Monetha Dockery at 410-786-0155. For all other 
issues call 410-786-1326.)

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    5. Type of Information Collection Request: Reinstatement of 
previously approved collection; Title of Information Collection: State 
Medicaid Eligibility Quality Control (MEQC) Sample Plans; Use: The 
Medicaid Eligibility Quality Control (MEQC) system is based on monthly 
state reviews of Medicaid and Medicaid expansion under Title XXI cases 
by states performing the traditional sampling process identified 
through statistically reliable statewide samples of cases selected from 
the eligibility files. These reviews are conducted to determine whether 
or not the sampled cases meet applicable state Title XIX or XXI 
eligibility requirements when applicable. The reviews are also used to 
assess beneficiary liability, if any, and to determine the amounts paid 
to provide Medicaid services for these cases. In the MEQC system, 
sampling is the only practical method of validating eligibility of the 
total caseload and determining the dollar value of eligibility 
liability errors. Any attempt to make such validations and 
determinations by reviewing every case would be an enormous and 
unwieldy undertaking. In 1993, CMS implemented MEQC pilots in which 
states could focus on special studies, targeted populations, geographic 
areas or other forms of oversight with CMS approval. States must submit 
a sampling plan, or pilot proposal to be approved by CMS before 
implementing their pilot program. The Children's Health Insurance 
Program Reauthorization Act (CHIPRA) was enacted February 4, 2009. 
Sections 203 and 601 of the CHIPRA relate to MEQC. Section 203 of the 
CHIPRA establishes an error rate measurement with respect to the 
enrollment of children under the express lane eligibility option. The 
law directs states not to include children enrolled using the express 
lane eligibility option in data or samples used for purposes of 
complying with the MEQC requirements. Section 601 of the CHIPRA, among 
other things, requires a new final rule for the Payment Error Rate 
Measurement (PERM) program and aims to harmonize the PERM and MEQC 
programs and provides states with the option to apply PERM data 
resulting from its eligibility reviews for meeting MEQC requirements 
and vice versa, with certain conditions. CMS reviews, either directly 
or through its contractors, of the sampling plans helps to ensure 
states are using valid statistical methods for sample selection. The 
collection of information is also necessary to implement provisions 
from the Children's Health Insurance Program Reauthorization Act of 
2009 (CHIPRA) (Pub. L. 111-3) with regard to the MEQC and Payment Error 
Rate Measurement (PERM) programs. Form Number: CMS-317 (OCN: 0938-
0148); Frequency: Semi-Annually; Affected Public: State, Local, or 
Tribal Governments; Number of Respondents: 10; Total Annual Responses: 
20; Total Annual Hours: 480. (For policy questions regarding this 
collection contact Monetha Dockery at 410-786-0155. For all other 
issues call 410-786-1326.)
    6. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: State 
Medicaid Eligibility Quality Control (MEQC) Sample Selection Lists; 
Use: The Medicaid Eligibility Quality Control MEQC system is based on 
monthly state reviews of Medicaid and Medicaid expansion under Title 
XXI cases by states performing the traditional sampling process 
identified through statistically reliable statewide samples of cases 
selected from the eligibility files. These reviews are conducted to 
determine whether or not the sampled cases meet applicable state Title 
XIX or XXI eligibility requirements when applicable. The reviews are 
also used to assess beneficiary liability, if any, and to determine the 
amounts paid to provide Medicaid services for these cases. In the MEQC 
system, sampling is the only practical method of validating eligibility 
of the total caseload and determining the dollar value of eligibility 
liability errors. Any attempt to make such validations and 
determinations by reviewing every case would be an enormous and 
unwieldy undertaking. At the beginning of each month, state agencies 
still performing the traditional sample are required to submit sample 
selection lists which identify all of the cases selected for review in 
the states' samples. The sample selection lists contain identifying 
information on Medicaid beneficiaries such as: State agency review 
number, beneficiary's name and address, the name of the county where 
the beneficiary resides, Medicaid case number, etc. The submittal of 
the sample selection lists is necessary for regional office validation 
of state reviews. Without these lists, the integrity of the sampling 
results would be suspect and the regional offices would have no data on 
the adequacy of the states' monthly sample draw or review completion 
status. The authority for collecting this information is Section 
1903(u) of the Social Security Act. The specific requirement for 
submitting sample selection lists is described in regulations at 42 CFR 
431.814(h). Regional Office staff review the sample selection lists to 
determine that states are sampling a sufficient number of cases for 
review. Form Number: CMS-319 (OCN: 0938-0147); Frequency: Monthly; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 10; Total Annual Responses: 120; Total Annual Hours: 960. 
(For policy questions regarding this collection contact Monetha Dockery 
at 410-786-0155. For all other issues call 410-786-1326.)
    7. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: 
Medicaid and Children's Health Insurance (CHIP) Managed Care Claims and 
Related Information; Use: The Payment Error Rate Measurement (PERM) 
program measures improper payments for Medicaid and the State 
Children's Health Insurance Program (SCHIP). The program was designed 
to comply with the Improper Payments Information Act (IPIA) of 2002 and 
the Office of Management and Budget (OMB) guidance. Although OMB 
guidance requires error rate measurement for SCHIP, 2009 SCHIP 
legislation temporarily suspended PERM measurement for this program and 
changed to Children's Health Insurance Program (CHIP) effective April 
01, 2009. Please see Children's Health Insurance Program 
Reauthorization Act of 2009 (CHIPRA) Public Law 111-3 for more details. 
There are two phases of the PERM program, the measurement phase and the 
corrective action phase. The PERM measures improper payments in 
Medicaid and CHIP and produces state and national-level error rates for 
each program. The error rates are based on reviews of Medicaid and CHIP 
fee-for-service (FFS) and managed care payments made in the federal 
fiscal year under review. States conduct eligibility reviews and report 
eligibility related payment error rates also used in the national error 
rate calculation. We created a 17 state rotation cycle so that each 
state will participate in PERM once every three years. Following is the 
list of states in which CMS will measure improper payments over the 
next three years in Medicaid. We need to collect capitation payment 
information from the selected states so that the federal contractor can 
draw a sample and review the managed care capitation payments. We will 
also collect state managed care contracts, rate schedules and updates 
to the contracts and rate schedules. This information will be used by 
the federal contractor when conducting the managed care claims reviews. 
Sections 1902(a)(6) and

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2107(b)(1) of the Social Security Act grants CMS authority to collect 
information from the States. The IPIA requires CMS to produce national 
error rates in Medicaid and CHIP fee-for-service, including the managed 
care component. The state-specific Medicaid managed care and CHIP 
managed care error rates will be based on reviews of managed care 
capitation payments in each program and will be used to produce 
national Medicaid managed care and CHIP managed care error rates. Form 
Number: CMS-10178 (OCN: 0938-0994); Frequency: Occasionally; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 34; 
Total Annual Responses: 2040; Total Annual Hours: 28,050. (For policy 
questions regarding this collection contact Monetha Dockery at 410-786-
0155. For all other issues call 410-786-1326.)
    8. Type of Information Collection Request: Reinstatement with 
change of a previously approved information collection; Title of 
Information Collection: Medical Necessity and Claims Denial Disclosures 
under MHPAEA; Use: The Paul Wellstone and Pete Domenici Mental Health 
Parity and Addiction Equity Act of 2008 (MHPAEA) (P.L.110-343) requires 
that group health plans and group health insurance issuers offering 
mental health or substance use disorder (MH/SUD) benefits in addition 
to medical and surgical (med/surg) benefits ensure that that they do 
not apply any more restrictive financial requirements (e.g., co-pays, 
deductibles) and/or treatment limitations (e.g., visit limits) to MH/
SUD benefits than those requirements and/or limitations applied to 
substantially all med/surg benefits.

Medical Necessity Disclosure Under MHPAEA

    The MHPAEA section 512(b) specifically amends the Public Health 
Service (PHS) Act to require plan administrators or health insurance 
issuers to provide, upon request, the criteria for medical necessity 
determinations made with respect to MH/SUD benefits to current or 
potential participants, beneficiaries, or contracting providers. The 
interim final rules Under the Paul Wellstone and Pete Domenici Mental 
Health Parity and Addiction Equity Act of 2008 (75 FR 5410, February 2, 
2010) set forth rules for providing criteria for medical necessity 
determinations. CMS oversees non-federal governmental plans or related 
health insurance.

Claims Denial Disclosure Under MHPAEA

    The MHPAEA section 512(b) specifically amends the Public Health 
Service (PHS) Act to require plan administrators or health insurance 
issuers to supply, upon request, the reason for any denial of payment 
for MH/SUD services to the participant or beneficiary involved in the 
case. The interim final rules Under the Paul Wellstone and Pete 
Domenici Mental Health Parity and Addiction Equity Act of 2008 (75 FR 
5410, February 2, 2010) implement 45 CFR 146.136(d)(2), which sets 
forth rules for providing reasons for denial of payment. We oversee 
non-federal governmental plans or related health insurance, and the 
regulation provides a safe harbor such that plans or issuers are deemed 
to comply with requirements of paragraph (d)(2) of 45 CFR 166.136 if 
they provide the notice in a form and manner consistent with ERISA 
requirements found in 29 CFR 2560.503-1. Form Number: CMS-10307 (OMB 
Control No. 0938-1080); Frequency: On Occasion; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 20,300; Number of 
Responses: 509,600; Total Annual Hours: 2,200. (For policy questions 
regarding this collection, contact Usree Bandyopadhyay at 410-786-6650. 
For all other issues call (410) 786-1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995, 
or Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected], or call 
the Reports Clearance Office on (410) 786-1326.
    In commenting on the proposed information collections please 
reference the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by July 30, 2013:
    1. Electronically. You may submit your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number --------, Room C4-26-05, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850.

    Dated: May 28, 2013.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2013-12950 Filed 5-30-13; 8:45 am]
BILLING CODE 4120-01-P